CN102892457B - Integrated vascular delivery system with safety needle - Google Patents

Integrated vascular delivery system with safety needle Download PDF

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Publication number
CN102892457B
CN102892457B CN201180024152.XA CN201180024152A CN102892457B CN 102892457 B CN102892457 B CN 102892457B CN 201180024152 A CN201180024152 A CN 201180024152A CN 102892457 B CN102892457 B CN 102892457B
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CN
China
Prior art keywords
epitheca
pin
hub
housing
catheter
Prior art date
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Active
Application number
CN201180024152.XA
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Chinese (zh)
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CN102892457A (en
Inventor
艾德丽安·R·哈里斯
史蒂芬·B·怀特
埃莉丝·凯默勒
内森·法雷尔
哈里·J·H·布朗
罗纳德·D·杜伊斯
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Tangent Medical Technologies Inc
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Tangent Medical Technologies Inc
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Application filed by Tangent Medical Technologies Inc filed Critical Tangent Medical Technologies Inc
Priority claimed from US13/111,716 external-priority patent/US8814833B2/en
Priority claimed from US13/111,693 external-priority patent/US8771230B2/en
Publication of CN102892457A publication Critical patent/CN102892457A/en
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Publication of CN102892457B publication Critical patent/CN102892457B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0606"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • A61M25/0625Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/325Means obstructing the needle passage at distal end of a needle protection sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0097Catheters; Hollow probes characterised by the hub
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0693Flashback chambers

Abstract

An integrated vascular delivery system and safety needle including: a frame having a catheter hub providing a first anchoring point and that receives a catheter that transfers fluid at an insertion site, and a stabilization hub providing a second anchoring point; a fluidic channel coupled to the catheter; a housing; a needle insertable through the frame; and a sheath telescopically engaged with the housing. The sheath couples to the frame such that needle removal from the frame transitions the sheath from a retracted position, in which the sheath exposes the needle, to an extended position in which the sheath surrounds the needle. The frame operates in a folded configuration in which each hub couples to the housing and/or sheath and in an unfolded configuration in which the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

Description

The integrated vascular delivery system with safty pin
The cross reference of related application
The application requires the rights and interests of following U.S. Provisional Application number: on June 21st, 2010 submit to 61/356,776, in 61,352,220 of submission on June 07th, 2010, in 61/407,777 of submission on October 28th, 2010, in 61/448,132 of submission on March 01st, 2011, in 61/346,292 of submission on May 19th, 2010, in 61/407,797 of submission on October 28th, 2010, in 61/418,349 of submission on November 30th, 2010, in 61/438,774 of submission on February 02nd, 2011, in 61/418,352 of submission on November 30th, 2010, in 61/438,778 of submission on February 02nd, 2011, in 61/418,354 of submission on November 30th, 2010, in 61/438,781 of submission on February 02nd, 2011, in 61/442,456 of submission on February 14th, 2011, in 61/418,358 of submission on November 30th, 2010, in 61/438,782 of submission on February 02nd, 2011, in 61/448,318 of submission on March 02nd, 2011, with on March 01st, 2011, submit to 61/448,140.13/111,716 the rights and interests that the application also requires the U. S. application submitted to May in 2011 19 number 13/111,693 and submits on May 19th, 2011.Each in these 17 provisional application and 2 non-provisional applications is incorporated to by originally quoting with its integral body.
Technical field
The present invention relates generally to medical field, and relates more specifically to the improved integrated vascular delivery system with safty pin in medical field.
Background
Intravenous injection (IV) therapy that stands a kind of form of the frequent needs of patient of therapeutic treatment, the intravenous administration that fluid is passed through patient in intravenous therapy is in patient.IV therapy is the most fast for fluid and drug delivery being entered to one of the mode of patient's health.The fluid of intravenous injection and transfusion typically comprises saline, medicine, blood and antibiotic, is introduced into patient routinely by being positioned in the catheter at any place in a plurality of veins path, and described a plurality of veins path is for example peripheral vein and central vein.Typically, catheter is used adhesive tape or similar catheter stabilizing device (CSD) with the pipeline being associated, for example, retrain the cohesive stabilisation pad of drain body, is fixed to the skin of being directly close to patient.Yet the conventional apparatus and method for IV therapy have shortcoming.Extending pipeline can be on the nigh barrier of hook during patient moving or care-giver's manipulation, and this can cause venous stimulation and the infringement IV of pain.The existing CSD of adhesive tape and other is optimum for stabilisation because circular, rigidity and parts large volume be fixed as be close to skin can be difficulty with poor efficiency.The existing CSD of adhesive tape and other prevents that catheter from moving at intravenous by halves, and the complication that this causes endangering patient comprises catheter displacement, infiltration (fluid enters tissue around, and non-vein) and phlebitis (inflammation of vein).Cohesive stabilisation pad is tending towards causing other unexpected effect, the skin irritation for example being caused by the dense adhesion to skin over a long time and/or deteriorated.In addition, adhesive tape and current CSD do not prevent that catheter from causing sorely and jeopardously around inserting position pivot, rotate and move at intravenous.
In addition, the placement of catheter assembly typically utilizes the pin being inserted in patient.By body contact, organize and fluid blood for example, such pin brings biohazard thing risk, comprises the transmission of disease that cross-contamination and blood carry, and is applied in the unexpected pin puncture on the user of medical treatment device.
Therefore, in medical field, have creating one or more improved vascular delivery system in the shortcoming overcome conventional vascular delivery system and the needs of safty pin.The invention provides so improved vascular delivery system with safty pin.
Accompanying drawing summary
Fig. 1 is the general view schematic diagram with the integrated vascular delivery system of safty pin;
Fig. 2-5th, the version of integrated vascular delivery system;
Fig. 6-14th, for the version of the catheter hub of coupling integration vascular delivery system and the means of stable hub;
Figure 15-21st, has the version of the isolator in the integrated vascular delivery system of safty pin;
Figure 22-27th, the version of the pin blunt mechanism in integrated vascular delivery system;
Figure 28 A and 28B are minute other retracted position of safty pin system and the schematic diagrams of extended position that is coupled in the first preferred embodiment of catheter hub;
Figure 29-32 are schematic diagrams of the housing in the safty pin system of the first preferred embodiment;
Figure 33 A-33C is the version of the pin in safty pin system;
Figure 34 A-34F is the schematic diagram of the epitheca in the safty pin system of the first preferred embodiment;
Figure 35 A-35F is the schematic diagram of the slider in the safty pin system of the first preferred embodiment;
Figure 36 A-36B and 37A-37B are the schematic diagrams of the version of the epitheca in the safty pin system of the first preferred embodiment;
Figure 38 A-38C is the schematic diagram in the coupling between epitheca, slider and housing between the operating period of the safty pin system of the first preferred embodiment;
Figure 39 and 40 is " closing " configuration of pawl and the schematic diagrams of " opening " configuration in the epitheca of version of safty pin system of the first preferred embodiment;
Figure 41 A-41F is the schematic diagram of slider of version of the safty pin system of the first preferred embodiment;
Figure 42 A and 42B are the schematic diagrams that divides other retracted position and extended position of the safty pin system of the second preferred embodiment;
Figure 43 A-43C is the schematic diagram of housing of the safty pin system of the second preferred embodiment;
Figure 44-46 are versions of the epitheca in the safty pin system of the second preferred embodiment;
Figure 47 and 48 is versions of the locking mechanism in the safty pin system of the second preferred embodiment;
Figure 49-50th, the schematic diagram of the method for the safty pin system of assembling the second preferred embodiment;
Figure 51-56th, the schematic diagram of the epitheca isolator in safty pin system;
Figure 57 is the schematic diagram of the draft chamber in safty pin system;
Figure 58-60th, has the schematic diagram of the pin protective cap in the integrated vascular delivery system of safty pin; And
Figure 61-70th, is used the schematic diagram of the method for the integrated vascular delivery system stability catheter with safty pin.
The description of preferred embodiment
The following description to preferred embodiment of the present invention is not intended to the present invention to be limited to these preferred embodiments, but intention makes any those skilled in the art can manufacture and use the present invention.
As shown in Figure 1, the integrated vascular delivery system 100 with safty pin of preferred embodiment comprises: framework 110, its have be configured to receive catheter 122 catheter hub 120, stablize hub 130 and cross member 140 that at least one extends between catheter hub and stable hub; Fluid passage 150, it is fluidly communicated with catheter; Housing 310, it comprises pin installation portion; Pin 320, the proximal end that it has the distal end of penetrable framework and is coupled in pin installation portion; And epitheca, itself and housing telescopically mesh.Catheter hub 120 is preferably provided in the first anchor point 112 on patient and is configured to be received in and inserts 102 places, position and can insert in patient the catheter 122 with conveyance fluid, and stable hub 130 be preferably provided in the second anchor point 112 on patient '.Framework 110 is preferably in folded configuration 114 and not operation in folded configuration 116, in folded configuration 114, catheter hub and stable hub can be coupled, and in folded configuration 116 not, the first anchor point and the second anchor point are distributed on and insert position 102 around so that framework 110 is anchored in to patient, thus stabilisation catheter.For example, in preferred embodiments, the first anchor point and the second anchor point are inserting the relative side at position, for example, at near-end and the far-end of side, or at the relative cross side that inserts position.Epitheca therein the distal end of epitheca exposed needle retracted position and wherein epitheca in the extended position of the distal end of pin, operate in fact.Epitheca preferably can be coupled in framework, makes to remove pin from framework epitheca is pulled with respect to pin, thus epitheca is converted to extended position.System 100 preferably includes catheter 122, for example, be embedded in the catheter in catheter hub 120, but system can selectively be configured to receive and/or be coupled in this separated catheter before or after separated conduit inserts in patient.
Integrated vascular delivery system can be used to the blood vessel that access for example stands the patient of intravenous injection (IV) therapy.System can be used to medicine, antibiotic, saline, blood or any suitable fluid administration in patient, and/or for fluid is removed from patient.System can be used to create, the stable and IV line that remains on peripheral vein or eparterial insertion position, for example, on arm, hands or lower limb, or for the central vein access on neck, breast, abdomen or any suitable IV place.Yet system can be used to create, stable and keep any suitable access to patient based on catheter, for example, for the catheter of the conveying of cerebrospinal fluid.The use of safty pin can reduce the risk from the cross-contamination of body fluid and infection and other biohazard, and reduces the risk to the unexpected pin injury of the user of manipulation medical treatment device.
1. integrated vascular delivery system
The framework 110 of integrated vascular delivery system works to be stabilized in system and the catheter on patient.As shown in Fig. 2-3, framework 110 preferably includes provides the catheter hub 120 of the first anchor point 112 on patient, the second anchor point 112 on patient is provided ' stable hub 130 and the cross member 140 that at least one extends between catheter hub and stable hub.In the selectable embodiment of framework 110, framework can comprise the hub of any suitable quantity and the cross member of any suitable quantity, framework is formed on insert position 102 around there is the besieged of any suitable shape and size or the not besieged periphery of part.Framework preferably allows insertion position visual of catheter, for example, by reserving in the catheter unlapped region of opening around, but selectively system can comprise the covering of the material that is transparent, translucent, opaque or any suitable type, on framework surface, extend to cover and insert position and/or catheter.
Catheter hub 120 is configured to receive catheter 122, catheter 122 can be embedded within catheter hub and be the part of the one of system, can be maybe the separated catheter that is coupled in catheter hub 120 before or after in inserting patient, for example, use to the snap fit in catheter hub 120.Selectively, any suitable part of framework can be configured to receive catheter.Catheter hub 120 preferably includes passage 124, and it is aimed at one heart with catheter, and this catheter may be received in catheter to the pin 320 using during the insertion in patient.As shown in Fig. 2 D, catheter hub and/or stable hub can comprise the biometric parameter sensor 126 of temperature, blood pressure or pulse rate for example of measuring patient.Sensor 126 can be additionally and/or any suitable parameter of sensing selectively, for example, about the parameter of the fluid through catheter, and for example pH or flow velocity.
Catheter hub and/or stable hub can have relatively wide and thin profile, and this can help that power is distributed on the larger region on skin and reduce patient to produce skin irritation, pain and other deteriorated chance.Thin profile can help to reduce hub and be hooked in or stumble at bed facility or the nigh of other and can make catheter in intravenous motion and cause the risk on for example catheter displacement of complication, infiltration and phlebitic barrier.Yet catheter hub and stable hub can have any suitable shape.Catheter hub and stable hub can comprise plastics rigidity or semirigid or other suitable material and/or softer material.For example, one or two hub the two can comprise for example plastic rigidity core of silicone of the softer material of use.
As shown in Figure 2 A, system can also comprise be coupled in catheter hub 120 and/or stable hub 130 fluid is delivered to at least one extension 160 and/or the fluid source joint 162 of fluid passage 150 from fluid source.The extension 160 that stress relieving for example, is provided while being pushed (handling from patient moving or care-giver) in system preferably by flexible conduit for example polymer conduit manufacture, but can be selectively the path by any other suitable material manufacture.Extension 160 preferably grows to is enough to provide stress relieving, if necessary, but be as short as, be enough to reduce extension and be hooked in or stumble the chance on nigh barrier.In another version, fluid passage 150 and/or extension 160 can be coiled, and spring-like, to provide stress relieving.The length of extension can be selectively any suitable length, and can depend on the concrete application of system.The dimension of other of extension, for example external diameter and internal diameter, also can depend on the concrete application of system.Fluid source joint 162 preferably includes the adapter (for example pole IV bag, syringe or the pump through pipeline fluid supply) that extension is attached to fluid source.Adapter can be the cloudy luer lock connection (Fig. 4 A and 4B) of standard or the three way cock (Fig. 4 C and 4D) that common and conventional IV bag interface is connected.Selectively, adapter can be any suitable sun or female connector of being connected with fluid source interface of being adapted to.In addition, luer lock connection or other fluid source joint can be directly coupled in catheter hub and/or stable hub, rather than are coupled in extension.
In the selectable form of system, system can comprise more than one extension 160 and/or fluid source joint 162, to help that the fluid from a plurality of fluid sources is side by side delivered to system.For example, in the embodiment of system that comprises two fluid passages, system can comprise first fluid is delivered to the first extension of first fluid passage and the second extension that second fluid is delivered to second fluid passage.Yet two extensions can be useful in the application of using of the same fluid passage 150 of the process that relates to two minutes other fluids and catheter.
Cross member 140 works with by catheter hub 120, with respect to stablizing, hub 130 is stable provides structural stability to framework 110.As shown in Fig. 2-4, framework preferably includes with catheter hub and stable hub and forms around two cross members 140 of the periphery of catheter.Two cross members can be approximately parallel, maybe can be with any intersection, nonparallel or other suitable orientation.For example, yet as shown in Figure 3, framework 110 can comprise the only periphery around catheter of part, uses a cross member to replace two.Each cross member 140 can be flexible, for example, to allow catheter hub and stable hub relative to each other with a lot of degree of freedom motions, be included in displacement (and follow-up displacement at draw direction) along the compression direction of the axis of catheter, the both direction of two axis along other the two displacement, the both direction of the axis along catheter the two distortion and in the two the bending of the both direction of two axis along other.Especially, cross member 140 can be reversibly flexible to allow framework 110 in catheter wherein and to be in the folded configuration that can be coupled.One or more cross members can be tubuloses.For example, cross member can be the medical pipeline of straight soft and flexible hollow channel shape substantially, but can be any suitable structure with tube chamber.
Fluid passage 150 works that fluid is delivered to catheter from fluid source, and in certain embodiments, fluid to from catheter, send, for example the fluid of removing from patient is transferred to exterior reservoir through catheter.As shown in Fig. 2 C, at least a portion of fluid passage 150 can be fixed at least one in hub and/or in the cross member of tubulose.As shown in Fig. 5 A-5C, at least a portion of fluid passage 150 can be additionally and/or selectively in the outside of hub and cross member.For example, at least a portion of fluid passage 150 can be moulded to catheter hub, stablize the outer surface of hub and/or cross member.Fluid passage 150 preferably includes knuckle section 152, and fluid flows in the different direction of the direction from catheter 122 therein.Especially, knuckle section 152 is preferably directed to the direction with opposite direction in catheter fluid stream, or with the turnings of approximately 180 degree.The knuckle section 152 of fluid passage 150 can be fixed or be embedded in catheter hub and/or stable hub.In one of system exemplary application, catheter is inserted in patient, make it thrust end towards the direction that approaches patient's heart, and the knuckle section of fluid passage 150 allows to support that the base of IV bag or other fluid source is retained as the head that approaches bed, or inserting the near-end at position in other mode, as typically practice in patient treatment environment.The fluid circulation crook minimizing of the interiorization in the knuckle section 152 of fluid passage 150 can be hooked on or stumble on nigh barrier and therefore upset catheter and the quantity of the external structure of IV setting.Another effect of knuckle section is, if the exterior line of IV in arranging is pulled or hooks, knuckle section can make the framework 110 can be by making catheter further be pulled in patient more effectively stabilisation catheter so.For example, therein catheter be placed on forearm, make it distal end in the general catheter that approaches patient's ancon is placed, if exterior line was unexpectedly pulled towards patient afterwards, so pipeline by so that the knuckle section of fluid passage 150 and catheter hub 120 are pulled towards patient, thus catheter is further pulled in patient's blood vessel rather than catheter is gone out from insertion section displacement.
In some version, system can comprise the fluid passage of, two or any suitable quantity.For example, second fluid passage 150 can be through the second cross member 140.Second fluid passage 150 preferably receives second fluid, and second fluid can be identical from the first fluid that is provided to first fluid passage 150 or different.As shown in Fig. 4 A-4C, system can also comprise the second extension 160 that second fluid is supplied to framework and catheter.Yet as shown in Fig. 4 D, system can comprise an only extension 160 that fluid is supplied to one or more fluid passages.Fluid passage can have at minute other entrance (Fig. 4 A and 4C) of stablizing on hub 130, maybe can be shared in the same entrance (Fig. 4 B and 4D) that the stream therein of stablizing on hub can be used valve or other fluid control device to be conditioned.In a version, the first and second fluid passages are preferably fluidly communicated with the same catheter in catheter hub 120, at the same point (Fig. 4 A and 4B) of the length along catheter or passage or different points (Fig. 4 C), locate to be coupled in catheter.In this version, comprise optimum system choosing in constrain fluids optionally one or two to catheter and therefore to patient's mobile flow system 154.Flow system 154 can comprise one or more valves 156, for example (Fig. 4 A and 4B), place, the junction surface between fluid passage 150 and catheter (Fig. 4 C and 4D) or any suitable place at extension place.Flow system can be additionally and/or is selectively used pressure drop, ventilation or any suitable technology to flow with the fluid of controlling between fluid passage and catheter.Flow system can also exist in comprising the embodiment of a fluid passage 150 only.In another version, first fluid passage and second fluid passage are preferably fluidly communicated with the catheter with dual lumens, make a catheter tube chamber be coupled in first fluid passage and another catheter tube chamber is coupled in second fluid passage.In another version again, first fluid passage and second fluid passage are fluidly communicated with minute other catheter.Other version is expanded on these versions, has three or more fluid passages.
As illustrated best in Fig. 2 D, preferably catheter hub 120 and stable hub 130 can be coupled in folded configuration 114 each other and the first anchor point and the second anchor point are distributed on and insert operation in the not folded configuration 116 around of position therein framework 110 therein.In order to help to realize folded configuration, framework 110 preferably allows catheter hub 120 and stable hub 130 relative to each other to move with a lot of degree of freedom.Especially, framework is preferably reversibly flexible or folding so that catheter hub and stable hub is folding toward each other, or with one in hub the surface of another hub and/or below pass through.
In folded configuration 114, catheter hub 120 and stable hub 130 can be coupled in each other, thus framework are fixed in folded configuration.When catheter hub and stable hub are coupled, these hubs are with respect to entering catheter hub 120 and the identical motion of pin 320 experience in catheter, for example catheter to during the insertion in patient.In the first version, catheter hub 120 and stable hub 130 can be coupled in each other by pin 320 and the interaction of catheter hub 120 and/or stable hub 130.In an embodiment of this version, as shown in Fig. 6 A-6D, stablize hub 130 and comprise extension 132, and catheter hub 120 can comprise the depressed part of groove 128 or other reception extension 132, but catheter hub 120 can comprise that extension 132 and stable hub 130 can comprise groove 120 in another embodiment.Extension 132 defines through hole 134, makes when extension 132 is inserted in groove 128, and through hole 134 is aimed in fact with the pin receive path 124 of catheter hub 120.In this version, framework 110 can be during catheter in patient inserts, for example, by the user (doctor) that catheter hub and stable hub are coupled by pin 320 is folded into folded configuration through the passages 124 of catheter hubs 120 and the through hole 134 that passes through extension 132.Selectively, during manufacture, for example, during assembling and/or packing, framework 110 can be folded and/or pin 320 can be through extension and the groove of hub.When pin 320 is recalled from hub, hub can be unfolded as folded configuration not by de-coupling and framework 110.As shown in Figure 7A and 7B, extension 132 can be when extension is no longer required, for example when framework 110 in folded configuration not and be ready to patient fixedly time, collapsiblely enter in hub.Catheter hub and stable hub can comprise extension and/or the groove of, two or any suitable quantity.For example, yet catheter hub 120 and/or stable hub 130 can be additionally and/or (are used the housing around pin) selectively in any suitable manner and interact to help the optionally coupling of catheter hub and stable hub with pin.
In the second version, as shown in Figure 9, catheter hub 120 and stable hub 130 can be coupled in each other indirectly by being coupled in mutually housing.For example, as shown in Figure 9, in the folded configuration of framework, catheter hub can be coupled in epitheca and is indirectly coupled in housing, and stable hub can be coupled in housing, and hub and framework is fixed in folded configuration thus is indirectly coupled.
In the 3rd version, as shown in Figure 10-12, catheter hub 120 and stable hub 130 can be coupled in each other indirectly by being coupled in mutually epitheca.In the first embodiment, as shown in Figure 10 A-10D, catheter hub can be coupled in epitheca, and stable hub can comprise the extension that can aim at catheter hub and/or epitheca, make additionally to pass extension and catheter hub through the pin of epitheca, be coupled thus catheter hub and stable hub, to a certain extent similar in appearance to the first version of hub coupling, except extension is received by epitheca.With in the first version of hub coupling similarly, extension can be contractile.In a second embodiment, stable hub can be coupled in epitheca by being entered by interference fit or snapping in the surface of epitheca, and catheter hub and stable hub thus are indirectly coupled.For example, as shown in Figure 11 A-11B, epitheca can comprise the recess of profile of at least one part of the periphery with stable hub, for example, stablize hub and be assemblied in two projections or the stake between it.In order to help such interference fit or snap fit, stablize hub and/or epitheca and can comprise for example molded portion of silicone, isoprene, thermoplastic elastomer (TPE) or any suitable material of soft compressible material.In the 3rd embodiment, as shown in Figure 12 A-12B, catheter hub and/or stable hub can be used connection part to be coupled in epitheca.In the present embodiment, stable hub has the extension that possesses through hole, and the extension with through hole can be embedded in catheter hub or between catheter hub and epitheca when framework is in folded configuration.Connection part can be laterally or longitudinally through catheter hub, stablize extension in hub and the pin of epitheca and/or housing.Yet connection part can be the connection part of the manual coupling of any suitable breech lock of being controlled by user or other the folded configuration that is provided for fixed frame.
In the 4th version, catheter hub, stablize hub, epitheca and/or housing and latch system mutually coupling so that framework is fixed in folded configuration and epitheca and is coupled in framework.For example, catheter hub 120, stablize each in hub 130 and epitheca 330 and comprise that at least one extension (for example boss or arm) or at least one groove, to receive the extension of in other part, make framework and epitheca interlocking.For example, as shown in Figure 13 A-13D, catheter hub 120 is included in the groove 172 of its proximal lateral, stablizes the stable hub boss 174 of distal side and the epitheca 330 that hub 130 is included in it and comprises the side arm 178 that epitheca boss 176 and/or at least one distal end from epitheca extend.As shown in Figure 14, when framework is in folded configuration, groove, boss and/or side arm interlocking.Especially, (1) epitheca side arm 178 is coupled in the proximal end (Figure 14 A and 14B) of catheter hub, catheter hub is seated in epitheca, (2) the stable hub boss 174 on the stable hub being reversed is coupled in catheter hub groove (Figure 14 C), and the epitheca boss 176 on (3) epitheca is coupled in and stablizes hub groove (Figure 14 D and 14E).In other embodiment, the different part of framework, epitheca and pin housing can comprise the different combination of extension and groove, snapping portion, magnet, breech lock and/or any suitable retention mechanism of mutual coupling.
In the 5th version, catheter hub 120 and stable hub 130 can be coupled in each other thus indirectly by interacting with the 3rd structural detail mutually, are coupled in each other.For example, as shown in Figure 8, when framework 110 is in folded configuration, piece 136 can be coupled in catheter hub 120 and stable hub 130 the two.Although piece 136 is shown as in Fig. 8, have concrete geometric configuration, piece can comprise switch, breech lock, stopper and/or any suitable securing member or other mechanism.Piece 136 remove the de-coupling that can help catheter hub 120 and stable hub, make the framework can be in folded configuration not.As another embodiment, when framework is in folded configuration, pin 320 can be coupled in catheter hub 120 and stable hub 130 the two, for example, during catheter inserts.After catheter inserts, pin remove the de-coupling that can help catheter hub 120 and stable hub.
In the 6th version, catheter hub 120 and stable hub 130 can slidably be coupled in each other.For example, one in hub can have side trench or passage, and another hub can have lateral ridge portion, and when framework 110 is in folded configuration, the groove of this lateral ridge portion and another hub meshes slidably.Another embodiment of this version can comprise the boss being inserted in groove, or any suitable mechanism.
In the 7th version, catheter hub 120 and stable hub 130 are used snapping portion, breech lock, magnet and/or any suitable securing member to be coupled in each other in the time of can be in framework 110 is folded into folded configuration.Securing member can be coupled in the separated part of catheter hub and stable hub mutually.The other version of the coupling of catheter hub and stable hub comprises the multiple combination of above version.In addition, catheter hub and stable hub can be coupled in any suitable manner, use or do not use the cooperation of pin to help coupling fixing or locking catheter hub and stable hub.
In folded configuration 116 not, as shown in Figure 2A and 2B, catheter hub 120 and stable hub 130 are by de-coupling, make framework 110 can be fixed in patient, make the first anchor point and the second anchor point 112 and 112 ' be distributed on around the insertion position 102 of catheter, stablize thus catheter.Framework 110 is preferably fixed in patient by catheter hub 120 and stable hub 130 are fixed on to patient at the first anchor point and the second anchor point respectively.Yet framework 110 can be additionally and/or is selectively fixed by fixing only catheter hub 120, any suitable part of only stablizing hub 130, cross member 140 and/or framework 110.Framework can selectively be positioned at the anchor point place stabilisation catheter that inserts any suitable place, place at position with respect to catheter.Framework 110, when being fixed in patient, make the integrated vascular delivery system can be than the conventional catheter fixture stabilisation catheter more effectively inserting an only side stabilisation catheter at position, because reduce rotatablely moving of the catheter that occurs during the care-giver that may arrange at normal patient moving and/or IV handles at two that insert position different side stabilisation catheters.Framework 110 is preferably used adhesive tape to be fixed in patient, but can be additionally and/or selectively use the binding agent of the downside that is positioned at catheter hub and/or stable hub; Elastic straps; By the fastening tape of the securing member such as hook, hook and rubber band; Or any suitable fixed mechanism fixes.
In a selectable embodiment, as shown in Fig. 5 A-5C, framework 110 comprises a catheter hub, two two cross members and fluid passages that are positioned at stable hub, each connection catheter and minute other stable hub of the side contrary with catheter hub of framework.In this version, each hub provides one minute other anchor point, make overall framework 110 comprise three anchor points 112,112 ' and 112 ".In other embodiment, framework can comprise the anchor point that is distributed in equably or unequally insertion position 102 any suitable quantity around.As shown in Figure 5 A, catheter hub 120, stablize hub 130 and cross member 140 can be integrated in a single part.Single part can comprise the material of single type, maybe can comprise the skin of the rigidity core of the first material (for example rigid material, for example plastics) and second material (for example soft material, for example silicone) of covering rigidity core.
Catheter hub, other the version of stablizing the configuration of hub and cross member can be similar in appearance to the U. S. application number 12/855 that is called " Integrated vascular delivery system " in name, in 013, describe, it is incorporated to by originally quoting with its integral body.In addition, framework can comprise that catheter hub and stable hub still lack cross member; For example, together with catheter hub can be coupling in chain connection mode with stable hub, make framework can and launch in folding (" closed hinge ") configuration to operate in (" hinge-opening ") configuration.
1.1 hub isolators
Catheter hub 120 preferably also comprises catheter hub isolator 200, after catheter hub isolator 200 works and returns insertion pin 320 with rut after catheter inserts, the inner passage 124 of sealing catheter hub 120, in case Hemostatic Oral Liquid and other potential biohazard thing or other fluid are from escape or the leakage of catheter hub 120.Catheter hub isolator 200 is preferably coupled in catheter hub 120, is preferably disposed in the inner passage 124 of catheter hub, and can be aimed at one heart with catheter.Catheter hub isolator 200 is preferably coupled in catheter hub 120 and comprises primary seal portion 210 and secondary seal portion 212, but isolator 200 can be additionally and/or is selectively coupled in stable hub.Primary seal portion 210 is the interior sealings that work as the first defence portion of opposing fluid escape, and secondary seal portion 212 is the outer seal portion that work as the second defence portion of opposing fluid escape.In certain embodiments, catheter hub isolator 200 can comprise still less or the more sealing similar in appearance to primary seal portion and secondary seal portion, and this can be suitable for some amount of applying to revise escape of liquid protection.Catheter hub isolator is preferably defined in the catheter hub isolator cavity 214 between primary seal portion and secondary seal portion, and it can hold the captive fluid through primary seal portion.Catheter hub isolator cavity 214 can be larger than the diameter of pin 320, to reduce the frictional force on pin during pin inserts through catheter hub isolator, increases thus the easiness through catheter hub isolator pin.Yet cavity can selectively closely be assembled, and/or can comprise material and/or the fluid absorbency material with lower coefficient of friction.
Catheter hub isolator 200 can comprise elastomeric material, and the diameter can with the passage 124 being slightly greater than in catheter hub 120, while making in being assembled into passage, the compression of catheter hub isolator 200 is caused being sealed in the annular gap between the outer circumferential edges of catheter hub isolator and the wall of the passage in catheter hub 120, prevent that thus fluid from escaping through annular gap, and further keep the coupling between catheter hub isolator 200 and catheter hub 120, similar in appearance to interference fit.Catheter hub isolator 200 can be additionally and/or selectively comprise be applied to isolator outer peripheral sealant material to prevent fluid passing through between isolator and catheter hub wall, and/or temporarily or be for good and all incorporated into catheter hub, for example use that sonic soldering connects, chemistry welding or binding agent.
As shown in Figure 15 A-15E, in preferred embodiments, isolator 200 comprises rigidity core 222 and is coupled in the compressible stopper 288 of rigidity core.Rigidity core is the frame structure that preferably includes the wall member 285 that has the back wall 224 in hole 286 and extend from back wall.Back wall 224 can be offered help isolator 200 is seated in to the flange in catheter hub 120.Wall member 285 is preferably parallel in fact, but can be with any suitable relative orientation that defines the gap between wall member.Compressible stopper 228 is partially or even wholly coupling in around rigidity core, cover or filler opening 286 and surrounding wall member 285 to be defined in the cavity 214 in the middle body of isolator.An end of compressible stopper forms primary seal portion 210, and another end in the hole of the covering back wall of compressible stopper forms secondary seal portion 212.The hole 226 of back wall allows into and goes out the pin puncture path of isolator cavity (and catheter).Rigidity core 222 is preferably by for example Merlon, acronitrile-butadiene-styrene (ABS) or other styrene manufacture of rigidity plastics, and compressible stopper 228 preferably comprises elastomeric material, for example isoprene or silicone.Yet rigidity core and compressible stopper can comprise any suitable material.Compressible stopper is preferably coupled in rigidity core in molded manufacturing process, but can be additionally and/or selectively comprise other coupling mechanism or technique, for example binding agent.
In the first version, as shown in Figure 16 A-16C, isolator is the division isolator 230 of division portion 232 of a part comprising along its length.Division portion is longitudinally divided into isolator that approximate two half-unit is divided or other a plurality of part.Division portion can be in the inner face vicinity of primary seal portion 210 termination, make division portion 232 partly advance and be engaged near primary seal portion along at least one of length of isolator, but division portion can be selectively any suitable length, comprise the whole length along isolator, make isolator comprise two separated parts.As shown in Figure 16 C, when isolator 230 is assembled in catheter hub 120, the passage of catheter hub preferably radially compresses separator materials with closure division portion, forms thus cavity 214 and secondary seal portion 212.Division isolator can be manufactured by injection moulding, and for example use has the mould with the cavity of isolator shape complementarity as shown in Figure 16 B.In another embodiment of this version, division portion can start and continue towards secondary seal portion at interior primary seal portion place.In another embodiment again of this version, isolator can longitudinally be divided along two or more lines, forms three or more division parts.
In the second version, as shown in Figure 17 A and 17B, isolator is to comprise that at least two are in series placed on isolator part 242 in catheter hub 120 or the dual grommet isolator 240 of " grommet ".One in isolator part forms primary seal portion 210 and another isolator part formation secondary seal portion 212.Isolator part 242 is preferably closely adjacent to each other, a part that makes their inside face be contact and form the fluid-tight sealing be close to catheter hub wall.The inside face of isolator part 242 can chamfering or is become Radiation to be defined in the isolator cavity 214 between isolator part, but isolator part can selectively have any suitable geometric configuration.Selectively, isolator part can be separated certain distance, and isolator cavity is formed by the wall of catheter hub 120 at least in part.In other the embodiment of this version, isolator can comprise that three or more are in series placed on the isolator part in catheter hub 120, for example, so that three or more sealings to be provided.
In the 3rd version, as shown in Figure 18 A and 18B, isolator 250 comprises at least two separated isolator parts 252 and is disposed in the inner sleeve 254 between isolator part.In this version, two isolator parts are in series placed in catheter hub 120, are directly adjacent to each other or are separated certain distance.One in isolator part forms primary seal portion 210 and another isolator part formation secondary seal portion 212.The inside face of isolator part 252 is preferably adapted to receive inner sleeve 254, for example, by defining the depressed part of axially aiming at.Inner sleeve 254 can be columniform and by controlling dimension to be assemblied in the depressed part of isolator part, have greatly to the internal diameter that is enough to form the cavity 214 of the diameter that adapts to pin 320.Inner sleeve 254 preferably rigidity and by thermoplastic or any other suitable rigid material, but inner sleeve can be by any suitable material manufacture.In other the embodiment of this version, isolator can comprise more than two isolator parts, for example, also comprise around the isolator part of the overcoat tubular of inner sleeve.
In the 4th version, as shown in Figure 19 A-19E, isolator 260 comprises housing and first and second isolator parts 262 with the first and second housing parts 264.In this version, as shown in Figure 19 E, isolator comprises far-end half part and is near-end half part of the substantial mirror image of far-end half part, and wherein each half part comprises housing parts 264 and corresponding isolator part 262.As shown in Figure 19 A and 19B, each housing parts comprises for receiving the chamber 266 of hourglass shape of the taper of corresponding isolator part.Taper in chamber 266 helps to reduce the relative motion between isolator part 262 and housing 264, for example translational motion.Each housing parts can also comprise that outer annular flange or other help reduce the protuberance of the translational motion between housing and catheter hub 120.Two housing parts 264 can be coupling in together and/or be coupled in catheter hub 120 by ultrasonic bonding, epoxy material or other binding agent, screw thread and/or any suitable coupling mechanism.As shown in Figure 19 C and 19D, each isolator part 262 preferably includes from one of isolator part and opens the cavity 263 that end extends internally, and isolator part is preferably assembled as the end abutment of opening of isolator part is close to each other.By this way, minute other primary seal portion and secondary seal portion 210 and 212 of closing end formation isolator 260 of isolator part, and the engaged end of opening of isolator part forms besieged isolator cavity 214.Housing and isolator part are preferably combined, and corresponding isolator is for example partly seated in, in (entered by molding or be pressed into) each housing parts, and the housing being combined and isolator part are preferably installed in catheter hub 120.
In selectable embodiment, isolator can only have primary seal portion.In the first selectable version of the present embodiment, isolator 200 is manufactured to be formed on the flexible material of the gas-tight seal on hub by self sealss.This self-packing isolator prevents that fluid from leaving catheter hub 120, contributes to form blood wherein and other fluid will not leave the closed system of catheter hub.In the second selectable version, as shown in Figure 20 and 21, isolator 200 can be with stopper stopper or sealed by the sealant material that user is applied to isolator for example.Before catheter inserts and during, the rear end of the passage of catheter hub can be held to open (Figure 20 A and 21A).After catheter is inserted in patient, user can artery-clogging (for example, by applying exterior orientation pressure), pin 320 is recalled from catheter and catheter hub 120, flowing out (Figure 20 B and 20B) from hub to prevent fluid in the rear end that stopper is placed on to catheter hub 120, and allows blood vessel to be communicated with (for example, by discharging the exterior orientation pressure on blood vessel) with catheter fluid.Stopper can comprise that separated restraint stopper (Figure 20), the user that are applied to catheter hub slide it to turn-off the slide unit (Figure 21) at the back of hub, hinge member and/or any suitable isolator part at back that user is rocked to hub.Any in these single sealing versions of isolator can in series be repeated to form two sealings (primary and secondary) or more sealing.
Isolator can be one or more in above-described embodiment and version, and/or be the U.S. Provisional Application 61/346 submitted on May 19th, 2010,292 and on October 28th, 2010 submit to 61/407, one or more in the embodiment of describing in 797, its each by originally quoting with its integral body, be incorporated to.In addition, isolator can be the mechanism of any suitable escape or the leakage from the catheter hub 120 that help prevent fluid.
1.2 needle shield
As shown in Figure 22-27, catheter hub 120 and/or stable hub 130 can comprise needle shield 190.Needle shield 190 work with pin after catheter inserts by the distal end of passivation pin 320 after recalling from catheter and catheter hub or protect user not suffer the distal end of pin 320.Needle shield 190 helps prevent to the unexpected acupuncture of user and the transfer of biohazard thing.Needle shield 190 is preferably coupled in catheter hub 120 and/or stable hub 130, but can be additionally and/or be selectively coupled in any suitable part of system.Needle shield 190 is clip preferably, and for example alligator clamp, still can selectively comprise any suitable passivation mechanism, for example cap.Conventionally, catheter to during the insertion in patient, pin 320 is through inactive needle shields 190 and enter (for example Figure 22 A) in catheter.After catheter is placed in patient, pin 320 from catheter, recalled at proximal direction and, for example due to pin 320 on the interaction of pin capture unit 106, pin 320 and needle shield 190 engagements.After pin capture unit 106 and needle shield mesh, needle shield is for example triggered, with the distal end (Figure 22 B) from catheter hub and/or the de-coupling of stable hub and covering or passivation pin.The distal end that movable needle shield 190 continues to cover pin 320 when pin is further recalled and remove from catheter hub 120 now.The pin capture unit 106 that triggers the de-coupling from hub of needle shield 190 can be one or more multiple version.In a version, pin capture unit 106 can be the loop configuration around pin main body, and it is stuck in a part for needle shield 190 when hub is recalled at pin.In another version, pin capture unit 106 can be included in pin and allow having free passage of pin process needle shield 190 through time in catheter hub 120, but at pin, when catheter hub 120 is recalled, is hooked in the barb needle shield 190.Selectively, pin capture unit 106 can be positioned on needle shield 190.Yet, can use any suitable version that contributes to the pin capture unit 106 that the engagement of pin and needle shield 190 and needle shield close from the drop out of gear of hub.
Needle shield 190 can be configured to one or more in multiple layout.In the first embodiment, needle shield 190 is coupled in catheter hub 120.In first version of this first embodiment, needle shield is coupled in the interior section of catheter hub 120 removedly.For example, needle shield 190 can be coupled in any suitable surface, inside of the surface, inside (Figure 22 and 24) of the proximal part of catheter hub 120, the distal portions of catheter hub 120 or catheter hub.As shown in Figure 22, needle shield 190 can be coupled in the surface, the inside at catheter hub sunken inside of catheter hub, or as shown in Figure 24, needle shield 190 can be coupled in the surface, inside that the outer surface with catheter hub of catheter hub flushes approx, for example, when framework is in folded configuration, be adjacent to stable hub.As another embodiment, needle shield 190 can be engaged in catheter hub 120 at the near-end (Figure 23 A) of isolator 170 and/or at the far-end of isolator 170.As another embodiment, needle shield is engaged on the isolator 170 interior (Figure 23 B) of catheter hub, for example, in the cavity in isolator, slit or other suitable acceptance division.As another embodiment again, needle shield 190 can be adjacent to excessive chamber 192.
In the second version of the first embodiment, needle shield 190 is coupled in the exterior section of catheter hub 120 removedly.For example, as shown in Figure 25 A and 25B, needle shield can be at least three some places and catheter hub 120 and/or pin 320 interactions.Needle shield can be coupled in catheter hub 120 at first a place, for example, be coupled in the outside (for example Figure 25 A) of hub or be coupled in recess or other the receive feature (for example Figure 25 B) on the proximal part of catheter hub 120.The distal end ground around pin 320 is closed at second point b place for needle shield 190.The rut of pin 320 returns and causes when pin capture unit 106 is when thirdly needle shield 190 is meshed at c place, and needle shield closes from catheter hub drop out of gear.In the present embodiment, needle shield can be alligator clamp, and it is configured such that when pin capture unit 106 on pin 320 meshes with needle shield during rut returns, and this engagement side by side triggers surrounds pin end at a b place and needle shield closes from catheter hub drop out of gear.Alligator clamp is preferably by with respect to pin controlling dimension, make to be defined in the distal end of pin 320 and the distance " x " of the distance between pin capture unit 106 is equal to or less than the distance " y " that is defined as the distance between a b and c approx, but alligator clamp can have any suitable geometric configuration.Yet needle shield can be any suitable for the mechanism at the outside passivation pin of catheter hub end.
In the second embodiment, needle shield 190 is coupled in stablizes hub 130.In first version of the present embodiment, as shown in Figure 26 A and 26B, needle shield is coupled in the interior section of stablizing hub removedly, in the mode of the mode similar in appearance to the first embodiment.For example, stable hub can comprise the boss of aiming in fact with catheter hub 120 when framework 110 is in folded configuration.Boss can define the depressed part that inner needle shield is coupled in it, or outer needles sheath can externally be coupled in boss.At catheter between resting period, framework 110 is preferably in folded configuration, and pin 320 is through boss, through needle shield and through catheter hub 120.From catheter hub 120 removes pin 320, needle shield merges and covering pin from stablizing hub 130 drop out of gears.At pin, from catheter hub rut, return and needle shield from stablizing after hub drop out of gear closes, framework 110 can be unfolded the not folded configuration into it.In the second version, needle shield 190 is coupled in the exterior section of stablizing hub removedly, particularly when framework 110 is in folded configuration, is coupled in the version of the exterior section of catheter hub similar in appearance to needle shield wherein.
The other selectable embodiment of needle shield comprises the multiple combination of the above version of needle shield.In other words, needle shield can be in inner side and/or the outside of catheter hub 120 and/or stable hub.For example, as shown in Figure 27, needle shield 190 can be directly coupled in the interior section of catheter hub 120 and be indirectly coupled in the exterior section of stablizing hub 130.As another embodiment, needle shield can be partly in catheter hub inner side and partly in catheter hub outside, or 3 contact pin sheaths of the first embodiment can be coupled in stable hub, rather than catheter hub 120.In addition, any needle shield in these versions can be coupled in the epitheca of at least a portion that covers pin main body, and pin deactivator and epitheca combination are held more than the distal end of pin only.
Needle shield can be one or more in above-described embodiment and version, and/or be the U.S. Provisional Application 61/418 submitted on November 30th, 2010,358, in 61/438 of submission on February 02nd, 2011,782 and on March 02nd, 2011 submit to 61/448, one or more in the embodiment of describing in 318, its each by originally quoting with its integral body, be incorporated to.In addition, needle shield can be the mechanism of the distal end of any suitable sufficiently covering and/or passivation pin.
2. safty pin system
In the first preferred embodiment, as shown in Figure 28 A and 28B, use the exercisable safty pin system 100 of integrated vascular delivery system or other medical treatment device to comprise: housing 310, it has pin installation portion 312; Pin 320, it has can be through the distal end of framework and the proximal end that is coupled in pin installation portion 312; Epitheca 330, itself and housing 310 telescopically mesh and in circumferential at least a portion around pin 320, wherein epitheca 330 operates in retracted position 332 and extended position 334; And slider 350, itself and epitheca and/or housing longitudinally mesh and comprise optionally the suppressor with epitheca engagement.In the retracted position 332 of epitheca, the distal end of epitheca exposed needle.In the extended position 334 of epitheca, epitheca is in fact around the distal end of pin.In the retracted position 332 of epitheca, the distal end of epitheca exposed needle.In the extended position 334 of epitheca, epitheca is in fact around the distal end of pin.Epitheca can be coupled in medical treatment device, and making to remove pin from medical treatment device will pull epitheca with respect to pin, thus epitheca is converted to extended position from retracted position.In preferred embodiments, suppressor is optionally meshed with epitheca, make (1) suppressor at epitheca, in retracted position and while being coupled in medical treatment device, be coupled in epitheca, and suppressor strengthens the coupling to medical treatment device of epitheca, and (2) suppressor is coupled from epitheca is de-when epitheca is in extended position, and suppressor weakens epitheca to the coupling of medical treatment device, reduce thus for epitheca is taken off to the needed power of coupling from medical treatment device.In other version, the pin when epitheca is pulled with respect to pin from during the removing of medical treatment device, slider automatically triggers the de-coupling completely of epitheca and medical treatment device.Pin remove preferably by pin away from medical treatment device pull to carry out, but selectively, pin remove can by medical treatment device away from pin pull to carry out.In other words, for epitheca from its retracted position be pulled to its extended position and for safty pin system from the de-coupling of medical treatment device, user (for example doctor) can remotely pull pin at proximal direction (or medical treatment device is systematically pulled away from safty pin at distal direction), allow thus epitheca to slide into its extended position from its retracted position, to cover the distal end of pin.In preferred embodiments, slider also comprises near-end joint portion 364 and distal joint portion 366.When epitheca is in extended position, the distal joint portion that the near-end joint portion of slider is coupled in housing 310 and slider is coupled in epitheca, thus epitheca is locked in extended position; Yet system can comprise any suitable for epitheca being locked in to the locking mechanism of extended position.
Housing 310 works to support epitheca 330 and slider 350, to support pin and/or so that user interface to be provided.As shown in Figure 29 A-29C, housing 310 comprises that pin is coupled in its pin installation portion 312.Pin installation portion is the heart placed in the middle axially on the distal end of housing and on housing preferably, but can be selectively in any suitable part of housing.Pin can be entered to make in pin installation portion the distal end of pin to extend out from the distal end of housing by molding, but pin can selectively be used snap fit, frictional fit, screw thread, epoxy material or be coupled in any suitable manner pin installation portion.
Housing 310 is meshed with epitheca 330 and/or slider 350 slidably or telescopically.Housing 310 comprises the interior section being accommodated in epitheca, and housing is slided in epitheca.Yet, selectively, housing can be tubulose or in other mode, be configured such that epitheca slides in housing.The interior section of housing can comprise the track 314 that slider 350 is meshed slidably along it.Track preferably along housing body longitudinally, and can be for example track (Figure 30 B-30D) of spine (Figure 30 A and 30D) and/or depression of outstanding track.In a version, as shown in Figure 29 A, housing comprises the one or more arcuation things 318 that form around the outside framework structure of epitheca and/or slider, for example bracket.
Housing 310 preferably includes the housing stopper 316 being configured to when epitheca is in extended position in abutting connection with the near-end joint portion of slider 350.In preferred embodiments, housing stopper 316 be close to near-end joint portion 364 (or other part of slider) in abutting connection with the relative position working with stationary housing and slider, contribute to thus epitheca to be locked in extended position.In a version, as illustrated best in Figure 29 C and 32, housing stopper 316 comprises springlock cantilevered arm, and its free end is in abutting connection with the near-end joint portion of slider.Housing stopper 316 can be setovered towards slider or deflection radially, for example with allow slider in a direction for example, through housing stopper (when slider at the distal direction with respect to housing through out-of-date) but with anti-skidding device in contrary direction for example, through housing stopper (when slider at the proximal direction with respect to housing through out-of-date).Selectively, other housing stopper can comprise slide latch, lever, button, housing and mechanism interactional another protuberance of slider or another suitable any suitable part in abutting connection with slider.As another alternative form, housing stopper can comprise and receives the near-end joint portion of slider or the hole of any suitable part.Housing stopper preferably forms with housing, but can be selectively at the assembly process of safety needle device, to be coupled in the separated part of housing.
In certain embodiments, as illustrated best in Figure 28, housing 310 can have one or more handles 311, and one or more handles 311 can be controlled and handle to user with handling safety needle system.Handle 311 is preferably incorporated in making in the relative side of housing and uses a hands fixedly to control to become two possible side handle parts.Handle 311 can comprise such as the feature of ergonomics profile, for improvement of the spine of the friction in handle part, such as the padded coaming of silicone or any suitable part that adds.In addition, the version of other of handle can comprise less or more handle part (for example single knob), and can be specific for concrete application.In certain embodiments, as shown in Figure 33, handle can work as hub bracket further, for example, for receiving catheter hub or stable hub, the hub bracket of for example describing in U.S. Patent Application No. 12/855,013, or other part of any suitable hub or medical treatment device.
Housing 310 is plastics and can being manufactured by a single piece preferably, for example, by the remainder with housing, form the injection moulding of pin installation portion, arcuation thing and/or handle.Housing can selectively comprise to be manufactured separatedly and in the second process, for example uses binding agent, locked joints or other securing member to be attached to a plurality of parts of the tubular portion of housing.Yet housing can be manufactured in any suitable manufacturing process, for example grinding, turning or stereolithography, and by any suitable material manufacture.
The pin 320 of safty pin system preferably has the medical grade pin of sleeve pipe, for example, for assisting the pin of the insertion of catheter.Pin can have specification or the size of the group that is selected from available gauge, for example normal diameter size.In a version, as shown in Figure 33 A, pin 320 can comprise the recess 322 along a part for the length of pin.Recess 322 is positioned in recess extended distance 326 places, and recess extended distance 326 is defined as the distance between the distal end of pin and the proximal edge of recess.In the exemplary embodiment with the common use of catheter, at endovascular catheter, between resting period, pin 320 is typically telescopically engaged in catheter, is formed on the annular space between the outer wall of pin and the inwall of catheter.In the time of in pin is placed on blood vessel, blood or other fluid are along the length process of pin, and the recess in pin allows a small amount of fluid (being called as " excessive ") process and enters in the annular space between pin and catheter.This " excessive " becomes visible by catheter for the user, and excessive appearance represents that pin has been placed in blood vessel.
In another version of pin 320, as shown in Figure 33 B, pin can be solid in fact pin rather than the pin with the hollow of sleeve pipe.For example, pin 320 can comprise that the trocar is as catheter introducer.In this version, pin can comprise sharp distal tip and the groove extending from the distal tip of pin.Groove 324 preferably receives excessive (Figure 33 C) when pin inserts in blood vessel, and excessive can be visible by catheter pipeline and/or catheter hub for the user.
The epitheca 330 of safty pin system preferably works to cover the distal end of pin 320 after pin end is no longer required, to help protecting user not punctured by fluid contamination and unexpected pin.Epitheca 330 operates in retracted position 332 and extended position 334, makes the distal end of epitheca exposed needle 320 in retracted position 332, and in extended position 334 epitheca from housing, extended and in fact around or cover the distal end of pin 320.In extended position, epitheca can cover whole pin main body, or an only part that comprises distal end for pin main body.
As illustrated best in Figure 34 F, epitheca 330 preferably includes one group of epitheca stopper, comprises the first stopper 336 and the second stopper 337.The first stopper 336 is configured to when suppressor 351 distal joint portion in abutting connection with slider 350 during by division part 340 engagement with epitheca.The second stopper 337 is configured to when epitheca is in extended position the distal joint portion in abutting connection with slider 350, and the relative in fact motion longitudinally that this prevents epitheca and housing, contributes to epitheca to be locked in extended position thus.Epitheca stopper can be additionally and/or selectively against any suitable part of slider.In a version, as shown in Figure 34 E, epitheca stopper 336 and 337 holes that can comprise in the sidewall that is defined at epitheca.Hole can have by the part periphery being defined by the gap between two or more division parts 340 in the sidewall of epitheca.For example, division part 340 can be relative member, and wherein each member has angled or has an end 342 of tooth.Relative angled end 342 defines the surperficial hole having for the distal joint portion in abutting connection with slider.Selectively, hole can be the hole with besieged periphery being defined in the sidewall of epitheca.In other version, epitheca stopper can comprise protuberance or other extension, for example, similar in appearance to any protuberance or extension in the version of housing stopper, or any suitable part of epitheca.
Epitheca 330 can comprise the matching characteristic that makes epitheca can be coupled in framework or other suitable medical treatment device.In a version, the distal end of epitheca is adapted to mechanically be coupled in medical treatment device.In a preferred embodiment, as shown in Figure 34 A-34E, matching characteristic comprises the pawl 342 longitudinally extending from the distal end of epitheca 330.Pawl 342 is preferably flexible and be coupled in the corresponding matching characteristic (for example outside joint portion, otch or pouch) on medical treatment device.Each pawl can be coupled in the division part 340 of the distal end of epitheca, and is preferably coupled in the suppressor boss 351 of slider.For example, as shown in Figure 34 F, each division part or pawl can define the suppressor groove 138 of minute other suppressor boss 351 that receives epitheca.In a version, pawl can have the profile (Figure 34 A) of approximate arc to meet the part of the sub-circular of medical treatment device.In other version, pawl can comprise hook-shaped end 344 (Figure 36 A and 36B) and/or the platform 346 (Figure 37 A and 37B) configuring for the specific corresponding feature on medical treatment device and/or slider 350.In being mechanically coupled in other version of medical treatment device, epitheca 330 can extend beyond the distal end of housing when epitheca is in retracted position, for example, so that the distal end of epitheca can be seated in the passage (isolator or other acceptance division) of medical treatment device.For example, medical treatment device can fetter the distal end of epitheca.As another embodiment, the distal end of epitheca 330 can comprise the extension mating with corresponding depressed part in medical treatment device, or medical treatment device can comprise the extension mating with corresponding depressed part on epitheca 330.The distal end of epitheca 330 can comprise other for being seated in the feature in another receiving unit of isolator or medical treatment device, for example have to the taper slightly that is assemblied in the narrower diameter in isolator, such as the friction characteristic of the constraint in isolator that can comprise epitheca 330 of flank or spine.The distal end of epitheca can be additionally and/or is selectively used magnet, binding agent, springlock, securing member or any suitable mechanical means to be coupled in medical treatment device.
In another version, the distal end of epitheca 330 is adapted to manually be coupled in framework.For example, as shown in Figure 34 A, epitheca can comprise the maintenance boss 348 extending from the distal end of epitheca, and it is provided for pressing against medical treatment device the finger rest that keeps boss, and epitheca and medical treatment device thus are manually coupled.The protuberance that keeps boss can laterally stretch out or extend from epitheca with any suitable direction.Keep boss 348 to provide auxiliary to user, using housing and pin 320 away from medical treatment device as counteracting force, epitheca is remained and is close to medical treatment device while pulling.As shown in Figure 34 D, keep boss 348 can comprise the bridge of the division part of connection epitheca stopper.Selectively, epitheca can comprise a plurality of maintenance boss, for example a maintenance boss 348 extending from each division part 340 or pawl 342 of epitheca.Keep boss 348 can comprise for helping user maintenance boss to be remained to the feature of being close to medical treatment device, for example the spine of lip, increase friction or for example silicone of coating that rubs.Keep boss can comprise binding agent and/or the mechanical attachment that maintenance boss is coupled in to medical treatment device, for example pin, snapping or breech lock.
In preferred embodiments, slider 350 works optionally to regulate the bonding force between epitheca and medical treatment device.Slider 350 can further contribute to epitheca 330 to be locked in the extended position on the distal end of pin.Slider 350 longitudinally extends and is meshed slidably with epitheca and/or housing along at least a portion of epitheca 330 and/or housing, and it is relative to each other longitudinally movable making housing, epitheca and slider.As shown in Figure 35 A-35E, slider 350 can comprise planar section 352 and epitheca insertion portion 346.Planar section preferably smooth in fact and with the slide of housing mesh, but can be selectively curved surface.Planar section 352 can comprise groove 356 (Figure 30 A) and/or the spine 358 (Figure 30 B) with track 314 complementations of housing 310, or any suitable profile.Epitheca insertion portion 354 is preferably located in the distal segment of slider, and is telescopically engaged in epitheca 330.As shown in Figure 35 D, epitheca insertion portion can have the cross-sectional profiles of approximate arc, or the profile of any suitable and cross-sectional profiles complementation epitheca, to allow epitheca insertion portion to be meshed slidably with epitheca.Epitheca insertion portion 354 preferably defines permission pin 320 processes and enters the hole 362 in epitheca insertion section.Hole 362 can be circle hole, groove or any suitable opening, to allow the relative longitudinal translation of slider 350 and pin 320.In certain embodiments, as shown in Figure 41, slider 350 can comprise protuberance 356, protuberance 356 is connected with the flexible pawl interface of epitheca 330, protuberance 368 when slider is recalled from medical treatment device is triggered pawl for " opening " configuration, thus automatically by epitheca 330 and the de-coupling of medical treatment device.
Epitheca insertion portion 354 preferably includes suppressor, suppressor and epitheca optionally mesh, and make when suppressor is meshed with epitheca, and suppressor strengthens the coupling to medical treatment device of epitheca, and when suppressor is closed from epitheca drop out of gear, suppressor weakens epitheca to the coupling of medical treatment device.In preferred embodiments, as shown in Figure 35 F, slider 350, particularly epitheca insertion portion 354, can comprise division part 340 that at least one can be inserted in epitheca or the suppressor boss 351 in the suppressor groove 338 on pawl 342.In the present embodiment, when epitheca be contracted and pawl 342 around when controlling medical treatment device, suppressor boss 351 is coupled in suppressor groove 338 and the anti-in fact claw stop of suppressor boss relative to each other moves, thus strengthened flexible pawl 142 controlling on medical treatment device.For example, when epitheca is extended (housing is moved away from medical treatment device on proximal direction), suppressor boss becomes by from the de-coupling of suppressor groove 338, make flexible pawl 342 more freely with respect to other motions, weaken thus the controlling on medical treatment device of flexible pawl 342.In other words, the suppressor boss 351 on slider is optionally coupling in suppressor groove 338 on epitheca effectively regulate for deflection pawl and epitheca the amount from the needed power of the de-coupling of medical treatment device.
Slider 350 preferably includes when epitheca 330 is in extended position in abutting connection with the near-end joint portion 364 of housing stopper and/or in abutting connection with the distal joint portion 366 of epitheca stopper.When epitheca 330 is in extended position, near-end joint portion and distal joint quality award from the ministry selection of land are fixing respectively with respect to the two sliding position of housing and epitheca, and this fixes epitheca 330 indirectly with respect to housing, thus epitheca 330 is locked in extended position.Selectively, system can comprise any suitable for epitheca being locked in to the locking mechanism of extended position.As illustrated best in Figure 35 E, the near-end joint portion 364 of slider 350 is preferably for example, on the proximal part of slider and be the laterally outside extension in abutting connection with housing stopper, boss.Near-end joint portion 364 can or can not comprise similar in appearance to the hole in the hole 362 of epitheca insertion portion, to allow pin 320 to pass through through near-end joint portion.The distal joint portion 366 of slider 350 is extension preferably, for example fritter or the capture unit of the seizure on epitheca insertion portion in the hole 336 of epitheca stopper.Selectively, distal joint portion 366 can be on any suitable distal portions of slider.As shown in Figure 49 and 41, near-end joint portion and distal joint portion can be outstanding towards the bottom of slider 350, but they can be outstanding in any suitable direction in the place on epitheca of the place on housing corresponding to housing stopper and epitheca stopper.In other version, near-end joint portion and distal joint portion can any suitable place on slider in and can each be hole or the extension corresponding to the type of the housing stopper on housing and the epitheca stopper on epitheca.
Generally in preferred embodiments, the part that the distal portions of epitheca is coupled in to medical treatment device relates to flexible pawl (it is the extension of the division part on epitheca) is coupling in around medical treatment device.As shown in FIG. 38 A, epitheca is preferably contracted, and the suppressor boss 351 on slider is inserted in the suppressor groove 338 in division part.When suppressor boss is inserted in suppressor groove, by anti-in fact claw stop, laterally move separately, the coupling between the strengthening of suppressor boss or lock pawl and medical treatment device.When housing and slider by away from medical treatment device pull, when thus epitheca is pulled with respect to pin, the distal joint portion of slider is temporarily in abutting connection with the first epitheca stopper 336, makes suppressor boss 351 keep being engaged in suppressor groove 338 and epitheca keeps being coupled in medical treatment device.In this intermediate steps, the distal joint portion of slider preferably overcomes against the first epitheca stopper the shearing force being caused by the friction between housing and slider.As shown in Figure 38 C, when housing is pulled further away from each other medical treatment device, housing slider away from medical treatment device pull, until the first stopper 336 is crossed by distal joint portion 366 and in abutting connection with the second epitheca stopper 337, now the near-end joint portion 364 of slider is in abutting connection with housing stopper 316.In addition,, when slider is crossed the first stopper 336, the part of any other of medical treatment device (for example the stable hub 130 in integrated vascular delivery system, described above) can be discharged from safty pin system and de-coupling.In addition,, as shown in Figure 38 B, when distal joint portion adjacency the second epitheca stopper, suppressor boss 351 closes from suppressor groove 338 drop out of gears, weakens thus the coupling between pawl and medical treatment device.For example, after this last step, user can easily provide is enough to separated (around the pin) epitheca extending and the power of medical treatment device.
In selectable embodiment, as shown in Figure 39-41, slider works when pin is recalled from medical treatment device, automatically to trigger the de-coupling between epitheca 330 and medical treatment device.In the present embodiment, as shown in Figure 39, pawl 342 can be biased into its median claw be tending towards controlling the matching characteristic on medical treatment device " sealing " configuration 341 in.As shown in Figure 40, pawl 342 can be handled with deflection, swing or in other mode and be moved in " opening " configuration 343 that its median claw laterally moves separately, make thus the de-coupling of epitheca 330 and medical treatment device 302 become possibility, for example, after epitheca has been pulled in its extended position.Pawl 343 can automatically be handled in " opening " configuration when housing and/or slider 350 are pulled away from medical treatment device on proximal direction, thus automatically epitheca 330 from the de-coupling of medical treatment device.In the present embodiment, as shown in Figure 41 E, slider 350 comprises the protuberance 356 being connected with the flexible pawl interface of epitheca 330, make when slider is recalled from medical treatment device, protuberance 368 triggers pawl in " opening " configuration, automatically takes off thus coupling epitheca 330 and medical treatment device.
In the second preferred embodiment, as shown in Figure 42 A and 42B, safty pin system 400 comprises: housing 410, and it comprises the pin installation portion 412 that is coupled in base 414, base 414 is positioned at the approximate axial center of pin installation portion 412 in housing 410; Pin 412, it has can pass framework or the distal end of other suitable medical treatment device and the proximal end that is coupled in pin installation portion 412; And epitheca 430, itself and housing 410 telescopically mesh and have and define the distal end wall 444 of pin hole 446 and the long rails 442 being meshed slidably by the base 414 with housing 410.Epitheca 430 therein the distal end of epitheca exposed needle retracted position 432 and wherein epitheca in fact around operation in the extended position 434 of the distal end of pin.Similar to the epitheca of the first preferred embodiment of safty pin system, epitheca 430 preferably can be coupled in medical treatment device, and the epitheca 430 that removes from medical treatment device of pin is pulled with respect to pin, thus epitheca is converted to extended position from retracted position.Also comprise locking mechanism 450 safty pin optimum system choosing.In the preferred embodiment of safty pin system, when epitheca is in extended position, the proximal part of epitheca 430 is in abutting connection with housing stopper or catch in housing, and locking mechanism 450 constrains in epitheca in extended position.In a version, locking mechanism 450 is the housing stoppers that comprise springlock cantilevered arm, and the free end of springlock cantilevered arm is configured to when epitheca is in extended position the proximal part in abutting connection with epitheca.Yet, can use any suitable locking mechanism.
The housing 410 of the second embodiment of safty pin system similarly works with the housing of the first embodiment of system.As shown in Figure 43 A-43C, housing 410 is tubulose preferably, define the passage 416 that telescopically meshes epitheca 430, and housing 410 and/or passage 416 are preferably microscler with columniform, but can selectively there is any suitable cross section, for example avette or approximate rectangle.Similar to the housing in the first embodiment, the housing 410 of the second embodiment comprises that pin 420 (it is preferably similar in appearance to the pin of the first embodiment) is coupled in its pin installation portion 412.Housing preferably also comprises pin installation portion 412 is anchored to the base 414 in housing.The pin installation portion 412 of housing is preferably located on the distal end of housing and preferably in housing, is positioned at approximate axial center.Yet, pin installation portion can be selectively from the off-centring of housing, or be located in the inside of housing or any suitable position on surface.Base is the feature of inwardly radially extending of stake, protuberance or other the interior wall that is coupled in housing preferably.Base 414 preferably meshes to help the assembling in retracted position and extended position and/or the operability of epitheca slidably with epitheca 430.Base 414 can have the shape of cross section of any suitable epitheca for guided slidable, for example square or rectangle.In addition, base 414 can have the shape of cross section of the transverse movement in housing that can help especially to reduce epitheca 430, for example dovetail.Housing 410 can also have the base that meshes slidably and guide epitheca in a plurality of passages 416 that are arranged on housing.For example, housing can have in a side of passage for guiding the first base of the upside of epitheca 430, and passage with respect in the contrary side of the first base for guiding the second base of the downside of epitheca 430.Pin installation portion 412 is preferably coupled in base 414, makes base that pin installation portion is anchored in to housing, but pin installation portion and base can selectively be independent of each other and be arranged in the inside of housing or any suitable position on surface.For example, base 414 can be to be positioned at along the vertical line identical with pin installation portion 412 or on the contrary wall of pin installation portion 412 or at the guide in any suitable place.As shown in Figure 44 C, the relative dimension of pin installation portion and base preferably forms the portion of dangling, and it is defined in alcove space 415 or depressed part between pin installation portion and housing.Alcove space 415 preferably by controlling dimension to hold the thickness of epitheca when epitheca is in extension mode, and do not allow epitheca to rock in housing on a large scale.
In certain embodiments, housing 410 also comprises one or more handles 418, and one or more handles 418 can be controlled and handle to user with handling safety needle system.Handle is preferably incorporated in making in the contrary side of housing and uses a hands fixedly to control to become two possible side handle parts.Side handle part can be can be maybe relative wide and extend (Figure 45 A) along the length of the essence of housing along the length of housing, relatively short and thin (Figure 43 A).Similar to the handle of the first preferred embodiment of system, handle 418 can comprise such as the feature of ergonomics profile, for improvement of the spine of the friction in handle part, such as the padded coaming of silicone or any suitable part that adds.In addition, the version of other of handle can comprise less or more handle part (for example single knob), and can be specific for concrete application.In certain embodiments, handle can be further used as hub bracket and work, for example, for receiving other suitable part of catheter hub 120 or stable hub 130 or medical treatment device.
As shown in Figure 43 C, the distal end of housing 410 can also comprise the crosspiece 417 that helps to support epitheca 430 when epitheca is in extended position.Crosspiece 417 preferably extends beyond the distal end of housing, preferably at least one downside of housing, supports for gravity the epitheca having extended with opposing, and can be smooth, bending or any for supporting the geometric configuration of epitheca.Crosspiece can comprise other for example, for example, for helping feature fixing or epitheca that support to have extended, the handle part of coat with rubber or tooth, or securing member, magnet, clip or binding agent.In addition, crosspiece can be used hinge to attach to housing, for example, for folding so that system is compacter between the storage life before or after using.Yet crosspiece can have any other suitable geometric configuration and/or layout.
The epitheca 430 of the safty pin system of the second preferred embodiment similarly works with the epitheca of the first embodiment of system.As illustrated best in 45A figure, epitheca 430 preferably slidably mates with housing 410, and epitheca is telescopically passed through in the passage of housing.Epitheca 430 be therein epitheca by the housing 410 of retracting at least in part and the retracted position 432 reconciling the exterior and interior of the body sheaths 430 of the distal end of exposed needle are extended from housing 410 and in fact around exercisable at least one extended position 434 of the distal end of pin.As shown in Figure 44-45, epitheca comprises the long rails 442 that other the part with base or housing meshes slidably, and the distal end wall 444 that contributes to cover the distal end of pin when epitheca is in extended position.
In a preferred embodiment, epitheca 430 comprises two parts, comprises near-end epitheca part 430a and far-end epitheca part 430b.As shown in Figure 44 A-44E, near-end epitheca part 430a and far-end epitheca part 430b are assembled to form integrated epitheca main body.As shown in Figure 44 E, near-end epitheca part 430a preferably includes snapping breech lock 431a and far-end epitheca partly preferably includes the snapping hole 431b that receives snapping breech lock 431a with snap fit fastening means.Yet, additionally and/or selectively, far-end epitheca part can comprise that snapping breech lock and near-end epitheca part can comprise snapping hole, or near-end epitheca part and far-end epitheca partly can or be attached in any suitable manner by screw thread, interference fit, magnet, binding agent.Near-end epitheca part and far-end epitheca part are preferably assembled in housing 410, be bonded on base and/or inside housing other inside protuberance around.At assembly process, far-end epitheca part can enter from the distal end of housing housing 410 and near-end epitheca part can enter housing from the proximal end of housing.In another version, epitheca comprise epitheca part and, preferably in long rails as described below, comprise and contribute to the feature of assembling in housing.
The long rails 442 of epitheca 430 works to guide the transformation between retracted position and extended position of epitheca.Long rails is groove preferably, but can be selectively the groove of engaged with base slidably, maybe can comprise the combination of single or multiple groove and/or groove.Long rails 442 is preferably parallel in fact the longitudinal axis of epitheca, the distal end from the proximal end of epitheca towards epitheca, and mesh slidably with another feature of base and/or pin installation portion or housing 410.
As shown in Figure 45 and 46, in single-piece epitheca version, long rails preferably include a series of by arc the reeded part of adjoining that is offset, and more preferably overlapping to form two such parts of the single track of the vicissitudinous width of tool at least in part.In preferred embodiments, as what illustrate best in " expansion " view of the track in Figure 45 C, the first rail portion 442a longitudinally extends to from the proximal end of epitheca along epitheca 430 partly along the point of the length of epitheca.In the present embodiment, the second rail portion 442b is preferably parallel to the first rail portion and extends in certain deviation angle of circumferential offset and along the whole in fact length of epitheca 430 from the first rail portion.Each in two rail portion is preferably equally wide with the width of the base of housing approx, or slightly wider than the width of the base of housing, make when base is meshed slidably with track 442, when epitheca 430 telescopically moves in housing 410, base 414 freely moves in long rails.In preferred embodiments, the first rail portion 442a slidably engaged with base to allow epitheca 430 in proximal direction process, until the end of the first rail portion, particularly, for example, at the assembly process of safty pin system, epitheca is retracted in housing at least in part.The second rail portion 442b is preferably with the engaged with base slidably of the different angle of circumference around epitheca 430, to allow epitheca to pass through towards complete retracted position at proximal direction further.The second rail portion 442b is engaged with base 414 also preferably, with for example with safty pin system, cover pin during, the extended position towards epitheca passes through at distal direction to allow epitheca.Although the first and second rail portion are preferably shared an edge at least in part, in other version, track 442 can comprise the rail portion with any suitable arrangement of any suitable quantity.For example, the first and second rail portion can be offset relatively large deviation angle, make the first and second rail portion not share edge.In addition, as shown in Figure 46 A, long rails part can for example, be engaged by cross track 442c or other open access (distal end of the opening of the epitheca as shown in Figure 46 B), makes the rotation in housing of epitheca that base can be advanced between rail portion.
The part of other of long rails 442 and/or epitheca 430 be preferably also defined in epitheca close end office work prevent that the epitheca having extended from fully leaving the seizure part 438 of housing 410.Capture unit 438 is preferably arranged on the close end office of epitheca and in abutting connection with base and/or pin installation portion when epitheca is in extended position.Capture unit 438 can be fitted in the alcove space 415 of housing.Another catches mechanism, and for example spring or breech lock can be additionally and/or be selectively used to prevent that epitheca from fully leaving housing.In one or more in these versions, epitheca is preferably limited to slide and exceeds the specific point extending (far-end) direction.
The distal end wall 444 of epitheca 430 works to cover in fact the distal end of pin when epitheca is in extended position, and when epitheca 430 is in retracted position, as the stopper against pin installation portion and/or base, work further, to prevent that epitheca is fully retracted in housing 410.Distal end wall 444 be formed on the distal end of epitheca in fact completely or the face of part, and define even as big as receiving and allow pin hole 446 or the hole of process of at least a portion of pin.Pin hole 446 can be opening (Figure 46 B) in the distal end wall of epitheca or can be in extending beyond the guide of distal end wall or part pin covering (Figure 49).For being limited to certain point, epitheca retraction (is for example less than in the housing 410 of fully retracting, make the distal end of epitheca still extend beyond the distal end of housing), distal end wall 444 can work as epitheca in retracted position time in abutting connection with pin installation portion and/or base, or additionally and/or selectively the proximal end of epitheca can be against proximal end wall or another stopper in housing 410.In at least one in these modes, epitheca is preferably prevented to slide to exceed the specific point shrinking (near-end) direction.
Similar in appearance to the epitheca of the first preferred embodiment of system, the distal end of epitheca 430 is adapted to mechanically and/or manually be coupled in medical treatment device.
The locking mechanism 450 of safty pin system works that epitheca 430 is constrained in extended position and prevents that epitheca is back to retracted position from extended position.In certain embodiments, safty pin system can be included in two or more locking mechanisms in epitheca 430 and/or housing 410.In a version, as shown in Figure 47 A-47D, locking mechanism 450 can be coupled in epitheca 430 and/or housing 410.For example, locking mechanism 450 can be the boss 452 that is coupled in epitheca, corresponding capture unit 454 in boss 452 engagement housings 410 or other stopper, for example near the capture unit 454 in (or other the suitable place in housing) base and pin installation portion or other stopper, to be locked in epitheca in extended position in fact.In single-piece epitheca, boss 452 is preferably near the proximal end of epitheca.In two pieces type epitheca, boss can be positioned in near-end epitheca part or far-end epitheca part.Boss preferably makes the process on proximal direction in housing 410 (for example, only in assembling) of epitheca 430 become possibility, simultaneously in fact when epitheca is in extended position, when boss engages catch portion, prevent the process on proximal direction of epitheca.For example, as shown in Figure 47 B, assembly process when epitheca 430 by proximal direction by entering housing 410 time, epitheca can be rotated to specific angle, make the preferably wall deflection towards housing 410 boss of base and/or pin installation portion, epitheca can be moved freely in housing 410 on proximal direction.As shown in Figure 47 C and 47D, in the operating period of safty pin system, when epitheca is pulled outwardly while moving to its extended position, the end that has barb of boss is meshed the capture unit of housing and stops in the capture unit of housing, prevents in fact thus the motion on proximal direction of epitheca and epitheca is constrained in its extended position.
In another version, as shown in Figure 48 A-48D, locking mechanism 450 comprises the housing stopper that is coupled in housing 410.In the extended position of epitheca 430, the capture unit of epitheca preferably in abutting connection with base or housing 410 other stopper and housing stopper in abutting connection with the proximal end face of capture unit, thus capture unit is captured between base and housing stopper.Housing stopper is springlock cantilevered arm or the boss on the wall of housing 410 preferably, and it is radially inwardly deflective (Figure 48 A) and/or have the protuberance (Figure 48 B) radially extending internally.In other version, locking mechanism 450 can be slide latch (Figure 48 C), lever (Figure 48 D), button or another suitable engageable with the capture unit of epitheca 430 against the base of housing capture, thus epitheca is locked in to the mechanism in extended position.In further version, locking mechanism 450 can be additionally and/or selectively in abutting connection with distal portions, middle body or any suitable part of epitheca.Locking mechanism preferably forms with housing 210, but can be selectively at the assembly process of safety needle device, to be coupled in the separated part of housing.
Preferably, the assembly process of safty pin or at needs epitheca 430 in extended position with before covering pin end, locking mechanism 450 is closed by drop out of gear or is not disturbed epitheca 430 on proximal direction, to move to the ability of its retracted position in other mode.For example, the free end of cantilever can extend in the alcove space 415 of base of contiguous housing 410, thereby outside the assembly path in epitheca, make assembly process cantilever can be not unexpectedly in abutting connection with the capture unit of epitheca 430 with prematurely epitheca is locked in extended position.In other version, when epitheca when being contracted (if for example need to be in unlapped words at assembly process or pin), locking mechanism can be closed by drop out of gear optionally according to its machinery essence, for example by slide latch or pivot rotating lever not stop epitheca.
As shown in Figure 49 A-49D, the method for the safty pin system 500 of assembling the second embodiment comprises: S510 in the distal end of the proximal end of epitheca insertion housing; The base of housing is engaged on to S520 in the first rail portion of long rails; The base of housing is advanced in the first rail portion of long rails, and epitheca is telescopically slid into at least one partially retracted position S530 in housing; Epitheca is rotated in housing to deviation angle S540, the base of housing is engaged in the second rail portion of long rails; And the base of housing is advanced in the second rail portion of long rails, epitheca is slided in housing to S550 in complete retracted position.As shown in Figure 49 E, method can also comprise pin is sterilized and/or helping to keep aseptic and protection user not to be subject to the protectiveness cap of unexpected acupuncture to be placed to S560 on the distal end of pin between transportation and storage life.This method can be used to the embodiment that assembling has the safty pin system of single-piece epitheca, but version 500 ' can similarly be used to the safty pin system that assembling possesses the epitheca with two or more parts.Another version 500 ' in, as shown in Figure 50 A and 50B, for the two pieces type epitheca version of package system, near-end epitheca part and far-end epitheca part are preferably coupled in each other around other housing stopper of base or housing.For example, method 500 ' can comprise S570 in the proximal end of near-end epitheca partial insertion housing, S580 in the distal end of far-end epitheca partial insertion housing, and near-end epitheca part and far-end epitheca partial coupling in S590 each other, preferably around base, be coupled.After assembling, epitheca is preferably similar to one heart and is enclosed within housing.Safty pin system is can be during manufacture assembled and when epitheca is in its retracted position or when epitheca is in its extended position, be provided to user.Selectively, safty pin system can be assembled by user before using.
2.1 epitheca isolators
In any one preferred embodiment, safty pin system can also comprise epitheca isolator 200 ' one or more embodiment, epitheca isolator 200 ' work with when pin by when medical treatment device is recalled when epitheca enters extended position through pin any body fluid, blood for example, or other potential biohazard thing is sealed in epitheca.Although epitheca isolator mainly illustrates jointly with the safty pin system of the first preferred embodiment, the second preferred embodiment of system can also comprise epitheca isolator 200 '.Epitheca isolator 200 ' be preferably coupled in epitheca 330 and more preferably in epitheca.Epitheca isolator 200 in safty pin system ' be configured to is coupled in catheter hub (or selectively any suitable medical treatment device) in fluid-tight mode, to help prevent the escape of liquid through the junction surface between catheter hub and safty pin system.For example, the end of epitheca isolator can circumferentially surrounded by catheter hub, or catheter hub can circumferentially surrounded by safty pin system isolator.As another embodiment, the junction surface between safty pin system and medical treatment device can comprise fluid-tight banjo fixing butt jointing and/or sealant.
As shown in Figure 51, epitheca isolator preferably include the first sealing 210 ' and the second sealing 212 '.The first sealing 210 ' be the defence portion that opposing is escaped from the fluid of an end of epitheca isolator, and the second sealing 212 ' as opposing, from the defence portion of the fluid escape of another end of epitheca isolator, work.In certain embodiments, epitheca isolator 200 ' can comprise still less or the more sealing similar in appearance to the first sealing and the second sealing, this can be suitable for some amount of applying to revise escape of liquid protection.The cavity that can hold captive fluid 214 between the first sealing and the second sealing of epitheca isolator 200 ' be preferably defined in '.Cavity 214 ' can be than the diameter of pin greatly to reduce the frictional force when epitheca isolator passes through pin.Yet cavity can be selectively closely matched with pin, and/or comprise material and/or the fluid absorbency material with lower coefficient of friction.In certain embodiments, pin can comprise other fluid issuing point, and for example, along its a plurality of recesses of length, and epitheca can comprise that longer epitheca isolator or a plurality of epitheca isolator are to hold a plurality of fluid issuing points on pin.One or more, described above similar in appearance in the version of catheter hub isolator of isolator 200 ' can be structurally.
As shown in Figure 51-53, in a version, epitheca isolator length, and epitheca isolator cavity length more preferably, at least equally long with the recess extended distance of pin, and be positioned as and make when epitheca is in extension mode, this recess is fully contained in epitheca isolator.As shown in Figure 54, in another version, catheter hub isolator length y and epitheca isolator length z summation are at least equally long with recess extended distance 326 seal length.In this version, catheter hub isolator 200 and/or epitheca isolator 200 ' can be shorter than recess extended distance respectively, but jointly, be equal to or greater than recess extended distance, so that recess extended distance is fully contained at least one in hub the combinatorial optimization of catheter hub isolator and epitheca isolator.
As shown in Figure 52 A and 52B, safty pin isolator 200 ' can be shorter than the length of epitheca 330, for example, near the distal end of epitheca, make when epitheca is in extended position, isolator holds the distal end that comprises pin of pin main body and the part of recess.Selectively, epitheca isolator can be at least identical in fact with epitheca length.For example, as shown in Figure 53 A and 53B, isolator can be and epitheca identical length approx, makes when epitheca is in extended position, and isolator holds the large part of pin main body.In another embodiment, as shown in Figure 54 A and 54B, epitheca can be at least to extend the same long to hold recess, still short than overall pin length with recess with isolator.
Similar in appearance to catheter hub isolator, epitheca isolator 200 ' can comprise elastomeric material, and the diameter can with the diameter that is slightly greater than epitheca, in the time of in being assembled into epitheca, make the compression of isolator by the annular gap sealing between the outer circumferential edges at isolator and the wall of epitheca, prevent that thus fluid from escaping through annular gap, and further keep the coupling between isolator and epitheca, similar in appearance to interference fit.Isolator can be additionally and/or is selectively comprised and be applied in the outer surface of isolator and the sealant material between epitheca, and/or temporarily or is for good and all incorporated into epitheca, for example, use that sonic soldering connects, chemistry welding or binding agent.
In any one preferred embodiment, safty pin system can also comprise capture unit 480, and capture unit 480 helps isolator 200 ' (or selectively the part that there is no isolator of epitheca 330) to be locked in the distal end of place on recess 122 and/or pin 120.Capture unit 380 can additionally and/or selectively be fixed on epitheca in extended position.As shown in Figure 33 A and 33B, in a version, capture unit can be coupled in the interior section of isolator, for example the alligator clamp in isolator cavity (or other part of isolator or epitheca), when epitheca is in its extended position, this alligator clamp engagement pin.When alligator clamp engagement pin, alligator clamp prevents the motion of epitheca on proximal direction, thus isolator locks in place.As also shown in Figure 56 A and 56B, in another version, capture unit is compressible ring 484 or the fritter on the outer surface of pin 120, it compresses when isolator 200 ' move through capture unit on distal direction, and when isolator covers the distal end of recess and/or pin, again expand, prevent thus that epitheca from moving on proximal direction and isolator locks in place.
In any one preferred embodiment, as shown in Figure 57, housing 110 can, outside epitheca isolator or alternative epitheca isolator ground, comprise the ventilator 272 of an end of draft chamber 270 and sealing draft chamber.Draft chamber 270 can be coupled in pin installation portion, and draft chamber is received through the blood of pin or other body fluid.In a version, draft chamber is included in the depressed part in the pin installation portion of housing, and the proximal end of pin is inserted in the entrance of draft chamber so that fluid is carried in draft chamber.In this version, the interface between pin and draft chamber is sealed further to defend to resist the release of fluid, for example, use filter, packing ring, O shape ring, epoxy material or any suitable encapsulant or mechanism.In addition, housing can comprise that an end that seals draft chamber is to prevent that fluid is through the ventilator 272 of the remainder of housing and safty pin system.Ventilator is preferably hydrophobic, prevents that fluid from leaving draft chamber and allowing air to leave draft chamber simultaneously, creates thus the pressure differential that the difference by between vascular pressure and atmospheric pressure in pin main body causes.Blood " excessive time " in this pressure official post pin enters in draft chamber.In another version, the proximal end of pin comprises the pin chamber volume being increased that receives fluid, and the draft chamber of housing receives pin chamber.In this version, fluid is accommodated in needle construction, needle construction and then be installed in housing.
3. pin protective cap
Integrated vascular system and/or safty pin system can be coupled in pin protective cap 460; pin protective cap 460 is before catheter inserts in patient; for example, in the packing of integrated vascular delivery device and/or safty pin system, cargo transport with between the storage life, the cross member that protection is folding or crooked.Pin protective cap 460 can also protect user or other operator not punctured by unexpected pin before pin and/or catheter insertion patient.As shown in Figure 58, the pin protective cap 460 of preferred embodiment comprises and is configured to receive the tube chamber 462 of pin and the depressed part that is configured to receive catheter hub.Selectively, protectiveness cap can be the sleeve around at least a portion of the pin exposing, and/or comprises and covering or the passivation stopper of the distal end of passivation pin.Yet, can use the cap of any other suitable type.In addition, cap can be used to only protect pin; For example, if integrated vascular delivery system is by not folded configuration intermediate package and cargo transport, cap can mainly work to cover pin so, and can be coupled in pin (additionally and/or being selectively coupled in any suitable part of integrated vascular delivery device and/or safty pin system).
As shown in Figure 59 A and 59B; pin protective cap 460 overall preferably at least equally high and/or at least equally loose with the dimension of at least folding cross member and/or pin, makes 460 carryings of pin protective cap originally for example, by the feature that the is applied in integrated vascular delivery device power (power horizontal with the axis of pin) on folding cross member for example.In one aspect; pin protective cap overall preferably equally high or higher than the height of folding cross member with the height of folding cross member, makes the carrying of pin protective cap originally by the crown force (overhead force) being applied on folding cross member.In yet another aspect, pin protective cap totally can be the same with the length that extends beyond housing of the pin exposing long or longer than the length that extends beyond housing of the pin being exposed with tube chamber 462.In yet another aspect, as shown in Figure 60 A, at least one point, pin protective cap totally can be equally loose or looser than the loosest width of folding cross member with the loosest width of folding cross member.In addition,, as shown in Figure 60 B, in selectable version, pin protective cap can also cover some or all of folding cross member and/or catheter hub, for larger protection.Pin protective cap can also comprise for carrying the sidewall of the horizontal power of other the axis with pin.
Pin protective cap 460 totally can by the elastomer of plastics rigidity or semirigid and/or resiliency for example silicone manufacture, but can be additionally and/or selectively use flexible plastic or any suitable material.Pin protective cap can be manufactured by the parts of single one, maybe can comprise a plurality of parts that are coupled.
The tube chamber 462 of pin protective cap works to receive and covers pin end, for example the distal end that is coupled in integrated vascular delivery system of the pin of safty pin system.In a version, tube chamber is from an end of cap, to extend to the through hole of the contrary end of cap.In another version, tube chamber is the cavity being closed on distal end.At two versions, in the two, tube chamber is preferably long than the length of the pin being exposed, and the distal end of pin is accommodated in tube chamber.In addition, tube chamber sterilizes before can being included in and inserting a needle in patient and/or further prevents the sterilization gel of being infected with of pin end or other material.What tube chamber can also comprise " handle part " or other is fixed on the inside lines on pin for helping pin protective cap.
The depressed part 464 that is configured to receive catheter hub 120 works that pin protective cap is fixed on to framework.In preferred embodiments, depressed part receives catheter hub and uses interference fit that pin protective cap is coupled in to integrated vascular delivery device.In selectable embodiment, pin protective cap can be additionally and/or is selectively comprised snapping portion, breech lock, capture unit or any suitable for pin protective cap being fixed on to the coupling mechanism of integrated vascular delivery device.Yet; pin protective cap can be additionally and/or is selectively coupled in any one or more suitable parts of framework and/or safty pin system, for example the stable hub of integrated vascular delivery device or flexible cross member or the pin housing of epitheca or safty pin system.
4. for stablizing the method for catheter
In preferred embodiments, as shown in Figure 61-69, for catheter being stabilized in to catheter on patient, inserting position method 600 around and comprise: provide to comprise catheter hub, be coupled in the catheter of catheter hub and the framework S610 of stable hub; To the safty pin system that comprises housing, pin installation portion is provided, is coupled in the pin of pin installation portion and the epitheca S612 telescopically meshing with housing, wherein epitheca operates in the extended position of the retracted position of the distal end of exposed needle and the distal end of covering pin; Catheter hub and the folding toward each other S620 of stable hub, thus framework is folded in folded configuration; Epitheca in retracted position is coupled in to other part S630 of catheter hub or framework; Catheter S640 in inserting position insertion patient; Housing away from catheter hub pull S650, thus epitheca is pulled to S652 in extended position; The epitheca having extended is taken off to coupling S660 and epitheca is locked in to S662 extended position from catheter hub; Launch framework S670, make framework in folded configuration not around inserting position; And framework is inserted to a plurality of anchor points place around, position and is fixed on patient 680 being distributed on, thus catheter with respect to inserting position stabilisation.
Catheter hub and the folding toward each other step S620 of stable hub are worked to expose to the end of catheter, this can help to provide clearization vision and/or physics to waiting to be positioned in the catheter that inserts position.As shown in Figure 62, catheter hub and stable hub are folded and thus framework folded in folded configuration toward each other.Folding step S620 can comprise stable hub is moved, catheter hub is moved or side by side the two moves towards each other catheter hub and stable hub towards the stable hub relative to static towards the catheter hub relative to static.In one embodiment, framework can by user, for example doctor be folding.In an embodiment of folding step S620, it be that the proximal part (with respect to patient) of framework and catheter hub be positioned as is the distal portions of framework that stable hub is positioned as.With respect to the insertion position on patient's forearm, stablize hub closer to ancon and catheter hub closer to hands.In the present embodiment, folding step S620 stable hub towards catheter hub away from patient fold.In another embodiment, before using, (for example, during assembling or packing) for example during manufacture, framework can be folded and/or pin can be inserted in catheter.For example, framework can be transported and provide to user in folded configuration, and the pin protective cap that makes epitheca in retracted position and make pin be coupled in framework, pin, epitheca, housing covers.Pin cap can further folding assisted step.In selectable embodiment, catheter hub and stable hub can be moved in any suitable relative motion, for example, relative to each other slide or distortion.
Folding catheter hub and stable hub S620 can also comprise coupling catheter hub and stable hub.Catheter hub and stable hub can be directly coupled in each other, maybe can by with three element, for example a part for safty pin system, pin protective cap or other part, be connected to each other and be indirectly coupled.For example, in one embodiment, method can comprise epitheca and/or housing are coupled in to stable hub, makes in conjunction with epitheca is coupled in to catheter hub, and catheter hub and stable hub are coupled in each other indirectly.
Epitheca is coupled in to catheter hub S630 can be comprised epitheca is mechanically coupled in to catheter hub.In a version, as shown in Figure 63 A, epitheca is mechanically coupled in to catheter hub and comprises a part for medical treatment device is arranged in the distal portions of epitheca, for example use flexible pawl around or control a part for medical treatment device or the feature of catheter hub be received in the acceptance division of epitheca.In another version, epitheca is mechanically coupled in to medical treatment device and comprises the distal end of epitheca is arranged on to S526 in the acceptance division of medical treatment device.In other version, epitheca is mechanically coupled in to medical treatment device and comprises manipulation snapping portion, breech lock, boss and groove, magnet or any suitable securing member.Selectively, as shown in Figure 63 B, the part that epitheca is coupled in to medical treatment device comprises the distal portions of epitheca is manually coupled in to medical treatment device S632, and this can be included in the maintenance boss of manually pressing epitheca on medical treatment device (or other part of other finger rest, extension or epitheca).In other version, epitheca is manually coupled in to medical treatment device and can comprises any suitable manual coupling step.
Catheter is inserted to S640 in patient and preferably include any suitable step for concrete application, for example, remove pin protective cap (before or after folding step), catheter is crossed to pin penetrate in blood vessel, or by the pin liquid of drawing blood.These steps are general and those skilled in the art are afamiliar with, but can use any suitable inserting step.As shown in Figure 64, the step that pin is inserted in patient can also comprise the part through medical treatment device, for example catheter hub pin insertion.
As shown in Figure 65, housing away from catheter hub pull S650 to start to allow epitheca towards extended position, to slide on distal direction.Housing away from catheter hub pull and comprise the coupling keeping between epitheca and catheter hub, but in preferred embodiments, coupling between epitheca and medical treatment device can be weakened after epitheca is in extension mode, reduces thus the amount for separated or de-coupling epitheca and the needed power of medical treatment device.Allow epitheca to extended position slip, comprising epitheca is pulled in extended position on distal direction.In one embodiment, allow epitheca comprising epitheca isolator is pulled to S652 with respect to pin towards distal direction slip, this allows epitheca to hold the escape of liquid from pin.When epitheca is in extended position, isolator preferably surrounds distal tip and the recess (if present) of pin.Step S650 and S652 are preferably similar to side by side and are carried out, but can selectively be carried out respectively and one after the other.
As shown in Figure 66 A and 66B, the distal portions of epitheca is comprised and reverse the machinery carrying out or the step that is manually coupled when the distal portions of epitheca is coupled in to catheter hub from the de-coupling of hub S660.De-coupling can comprise removes, epitheca is removed, discharged from catheter hub manual retentivity or any suitable step of coupling catheter hub and epitheca catheter hub in epitheca.In certain embodiments, the interaction of epitheca, slider and housing triggering epitheca is coupled from catheter hub automatic trip.After de-coupling step, pin be accommodated in the epitheca having extended and safty pin system by from catheter hub fully drop out of gear close.
It can be one or more in multiple version that epitheca is locked in to S662 in extended position.In a version, for example use the safty pin system of the first embodiment, as shown in Figure 67 A-67C, locking epitheca S662 comprises slider is longitudinally wedged to S664 between the epitheca that extended and housing.Wedging slider S664 preferably includes the proximal end of slider is coupled in to housing S666 and the distal end of slider is coupled in to epitheca S668, prevents thus the relative lengthwise movement between epitheca and housing.In another version, locking epitheca comprise allow locking mechanism the proximal part of epitheca against stopper.In the 3rd version, locking epitheca comprises permission epitheca and pin and capture unit engagement.Capture unit can be coupled in epitheca and by with pin engagement (for example the isolator of epitheca or the alligator clamp in other part), and/or capture unit can be coupled in pin and by with epitheca engagement the compressible ring of the outer surface of pin (for example around).Yet, epitheca is locked in extended position and can comprises any suitable step.
Launch framework S670 and work that framework be not orientated around inserting position in folded configuration.As shown in Figure 68, launch framework S670 and preferably reverse the motion of carrying out in the step of folded frame on catheter hub and stable hub, but can be additionally and/or selectively comprise other suitable step, for example catheter hub and stable hub in another direction motion, a part for distortion framework or a part for sliding frame.
Framework is inserted to a plurality of anchor points place around, position and is fixed on patient 680 and works with framework being distributed on, and catheter thus, with respect to inserting position, stablize.Fixed frame comprises to be fixed catheter hub and stable hub is fixed at the second anchor point place at the first anchor point place.As shown in Figure 69, the first anchor point and the second anchor point are distributed on and insert around position, preferably in the relative in fact side of inserting position.More preferably, as shown in Figure 70, a near-end at insertion position in anchor point and another anchor point are at the far-end that inserts position.Yet the first anchor point and the second anchor point can be distributed in any suitable manner and insert around position.In a version, fixed frame can also comprise to be fixed framework at the 3rd anchor point place, the first anchor point, the second anchor point and the 3rd anchor point is distributed on and inserts around position.Framework can be also fixed in patient at four or more anchor points place.A plurality of anchor points can be similar to equably or unequally be distributed in to be inserted around position.Fixing step can comprise framework gluing for example, in patient's (using medical belt or aseptic cohesive dressing), use binding agent that framework is adhered to patient, framework is bundled in to patient or any suitable fixed mechanism.
As shown in Figure 69, method can also comprise dressing is applied in to the step S690 inserting on position and framework.The step of using dressing works to protect the opposing of insertion position antibacterial, virus and other pathogen.The aseptic dressing that dressing is preferably breathed freely.Dressing is preferably transparent in to allow inserting the visual of position, and comprises that binding agent is to attach to patient's skin and so that the fixing of framework to be provided.Dressing can be used after framework is fixed in patient, or dressing can be used to framework to be fixed on patient.Yet dressing can comprise any suitable device or method for auxiliary protection insertion position.
In another embodiment, method can also comprise uses isolator stopper, is preferably applied to the proximal part (for example pin receive path) of catheter hub, and this works to help to prevent after catheter inserts fluid from catheter escape or leaks.Isolator stopper can be used in one or more modes, depend on the essence of stopper, and use isolator stopper can comprise isolator stopper with respect to catheter hub slide (for example isolator is sliding door), passage (for example isolator is stopper) or any suitable step in blocking-up catheter hub.
In another embodiment, method can also comprise at least one distal portions of pin and the needle shield engagement that is coupled in catheter hub and/or stable hub.Needle shield preferably works to cover the distal end of pin and can be alligator clamp, cap or any suitable mechanism.Needle shield can be inner or outside at catheter hub, stablize hub inside or outside, or be coupled in any suitable part of framework.In this version, insert catheter can also be included in a pin from catheter hub, recall before, simultaneously or afterwards needle shield from catheter hub and/or the de-coupling of stable hub.The action that pin inserts and/or pin rut returns can trigger needle shield from catheter hub and/or the de-coupling of stable hub.By this way, pin can fully be recalled from catheter hub, still by needle shield, is meshed and/or covers simultaneously.
If those skilled in the art is by the detailed description from above and recognize from accompanying drawing and claim, can make the modification of preferred embodiment of the present invention and change, and do not depart from of the present invention in following claim limited scope.

Claims (9)

1. a system with safty pin, comprising:
Housing, it comprises pin installation portion;
Pin, the proximal end that it has the distal end of penetrable medical treatment device and is coupled in described pin installation portion;
Epitheca, itself and described housing telescopically mesh and in circumferential at least a portion around described pin, wherein said epitheca operates in retracted position and extended position:
In described retracted position, described epitheca exposes the distal end of described pin; And
In described extended position, described epitheca is around the distal end of described pin;
Wherein said epitheca can be coupled in medical treatment device, and making to remove described pin from described medical treatment device will pull described epitheca with respect to described pin, thus described epitheca is converted to described extended position from described retracted position; And
Slider, at least one in itself and described epitheca and described housing longitudinally meshes and comprises the suppressor that optionally meshes described epitheca, wherein:
When described suppressor is engaged in the described epitheca in described retracted position, in described retracted position, described suppressor strengthens the coupling of described epitheca and described medical treatment device; And
When described suppressor is closed by the described epitheca drop out of gear from described extended position, described suppressor weakens the coupling of described epitheca and described medical treatment device.
2. system according to claim 1, wherein said housing comprises the interior section being telescopically engaged in described epitheca, wherein said epitheca is configured to telescopically mesh around described slider, and wherein said housing comprises at least one arcuation thing, described at least one arcuation thing is configured to form at least in part the outside framework structure around described epitheca and described slider.
3. system according to claim 1, wherein said needle set has tube chamber.
4. system according to claim 1, wherein said slider comprises near-end joint portion and distal joint portion, wherein when described epitheca is in described extended position, described near-end joint portion is coupled in described housing and described distal joint portion is coupled in described epitheca, thus described epitheca is locked in described extended position.
5. system according to claim 4, wherein said epitheca comprises epitheca stopper, described epitheca stopper is configured to when described epitheca is in described extended position the described distal joint portion in abutting connection with described slider, and the described distal joint portion of wherein said slider is configured to the extension that blocked by described epitheca stopper.
6. system according to claim 1, also comprises framework, and described framework comprises:
Catheter hub, it provides the first anchor point on patient, and wherein said catheter hub is configured to receive and can inserts in patient with the catheter inserting position conveyance fluid; And
Stablize hub, it provides the second anchor point on described patient;
Wherein said framework is in folded configuration and in folded configuration, do not operating;
Fluid passage, it is fluidly communicated with described catheter;
Wherein, in the described folded configuration of described framework, each is coupled at least one in described housing and described epitheca described catheter hub and described stable hub; And wherein, in the described not folded configuration of described framework, described the first anchor point and described the second anchor point are distributed on described insertion position around so that described framework is anchored in to described patient, stablize thus described catheter.
7. system according to claim 6, wherein in the described not folded configuration of described framework, with respect to described patient, in described the first anchor point and described the second anchor point one is configured to be configured to the far-end at described insertion position at the near-end at described insertion position and another in described the first anchor point and described the second anchor point.
8. system according to claim 6, wherein said catheter hub comprises the hub isolator with hub isolator cavity and hub isolator length, described epitheca comprises the epitheca isolator with epitheca isolator length, and described pin comprises the recess that is positioned in recess extended distance place, described recess extended distance is defined as the distal end of described pin to the distance between the proximal edge of described recess, and the summation of wherein said hub isolator length and described epitheca isolator length is more than or equal to described recess extended distance.
9. system according to claim 4, wherein said slider comprises the part of plane and is telescopically engaged on the nonplanar epitheca insertion portion in described epitheca, and wherein said housing comprises housing stopper, described housing stopper is configured to the described near-end joint portion of the described slider of adjacency when described epitheca is in described extended position.
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Applications Claiming Priority (39)

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US34629210P 2010-05-19 2010-05-19
US61/346,292 2010-05-19
US35222010P 2010-06-07 2010-06-07
US61/352,220 2010-06-07
US35677610P 2010-06-21 2010-06-21
US61/356,776 2010-06-21
US40777710P 2010-10-28 2010-10-28
US40779710P 2010-10-28 2010-10-28
US61/407,777 2010-10-28
US61/407,797 2010-10-28
US41835810P 2010-11-30 2010-11-30
US41835210P 2010-11-30 2010-11-30
US41834910P 2010-11-30 2010-11-30
US41835410P 2010-11-30 2010-11-30
US61/418,349 2010-11-30
US61/418,352 2010-11-30
US61/418,358 2010-11-30
US61/418,354 2010-11-30
US201161438782P 2011-02-02 2011-02-02
US201161438781P 2011-02-02 2011-02-02
US201161438774P 2011-02-02 2011-02-02
US201161438778P 2011-02-02 2011-02-02
US61/438,781 2011-02-02
US61/438,774 2011-02-02
US61/438,778 2011-02-02
US61/438,782 2011-02-02
US201161442456P 2011-02-14 2011-02-14
US61/442,456 2011-02-14
US201161448132P 2011-03-01 2011-03-01
US201161448140P 2011-03-01 2011-03-01
US61/448,132 2011-03-01
US61/448,140 2011-03-01
US201161448318P 2011-03-02 2011-03-02
US61/448,318 2011-03-02
US13/111,716 US8814833B2 (en) 2010-05-19 2011-05-19 Safety needle system operable with a medical device
US13/111,693 2011-05-19
PCT/US2011/037230 WO2011146764A1 (en) 2010-05-19 2011-05-19 Integrated vascular delivery system with safety needle
US13/111,693 US8771230B2 (en) 2010-05-19 2011-05-19 Integrated vascular delivery system
US13/111,716 2011-05-19

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Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8323249B2 (en) 2009-08-14 2012-12-04 The Regents Of The University Of Michigan Integrated vascular delivery system
US8814833B2 (en) 2010-05-19 2014-08-26 Tangent Medical Technologies Llc Safety needle system operable with a medical device
WO2011146769A2 (en) 2010-05-19 2011-11-24 Tangent Medical Technologies Llc Integrated vascular delivery system
US20130158506A1 (en) * 2011-05-19 2013-06-20 Tangent Medical Technologies Llc Catheter and needle system and method of inserting a catheter
US8979802B2 (en) * 2013-03-15 2015-03-17 B. Braun Melsungen Ag Safety IV catheter assembly with seal
EP3102258A4 (en) 2014-02-04 2017-12-27 ICU Medical, Inc. Self-priming systems and methods
CN107921241B (en) * 2015-07-02 2021-05-25 B.布劳恩梅尔松根股份公司 Catheter device with integrated tubing management mechanism and related methods
US10625028B2 (en) * 2017-06-28 2020-04-21 Retractable Technologies, Inc. Safety syringe with needle redirection device
US10646148B2 (en) * 2017-09-22 2020-05-12 Retractable Technologies, Inc. Bodily fluid collection device with integral tube seal
WO2019234748A1 (en) * 2018-06-07 2019-12-12 Xact Robotics Ltd Attachment appratus for a body mountable medical device
US11446472B2 (en) * 2018-08-23 2022-09-20 Becton, Dickinson And Company Low-drag septum for a catheter system
US20200078564A1 (en) * 2018-09-10 2020-03-12 Becton, Dickinson And Company Peripheral intravenous catheter assembly having an extension set
WO2020066781A1 (en) * 2018-09-25 2020-04-02 テルモ株式会社 Catheter assembly
CN112546405A (en) 2019-09-10 2021-03-26 巴德阿克塞斯系统股份有限公司 Rapid insertion central catheter and method
EP4028100A4 (en) 2019-09-24 2023-11-22 Bard Access Systems, Inc. An integrated acute central venous catheter and peripherally inserted venous catheter
MX2022008713A (en) 2020-01-23 2022-08-11 Bard Access Systems Inc Splitable catheter docking station system.
JP2023523934A (en) 2020-04-23 2023-06-08 バード・アクセス・システムズ,インコーポレーテッド Rapid-entry central venous catheter with catheter assembly
US11819638B2 (en) 2020-05-21 2023-11-21 Bard Access Systems, Inc. Rapidly insertable central catheters including catheter assemblies and methods thereof
CN114533055A (en) * 2020-11-18 2022-05-27 贝克顿·迪金森公司 Blood collection device, system, and blood collection method
US20220193376A1 (en) * 2020-12-21 2022-06-23 Bard Access Systems, Inc. Optimized Structural Support in Catheter Insertion Systems

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4380234A (en) * 1979-08-16 1983-04-19 Baxter Travenol Laboratories, Inc. Infusion needle attachment
US5643216A (en) * 1995-06-08 1997-07-01 White; James E. Patient bracelet having catheter capture integrally formed therewith and methods of making the same
JP2910915B2 (en) * 1995-03-07 1999-06-23 ベクトン・ディキンソン・アンド・カンパニー Assembly of catheter and needle introducer with needle retraction device
CN101466431A (en) * 2006-05-22 2009-06-24 贝克顿·迪金森公司 Catheter assembly with tip shield closure
US7651481B2 (en) * 2004-12-30 2010-01-26 CareFusion 303 Inc. Self-sealing male connector device with collapsible body

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3782383A (en) * 1973-03-06 1974-01-01 Vicra Sterile Inc Winged infusion holding device with thermoplastic elastomeric body
AU4131793A (en) * 1992-06-26 1994-01-06 Critikon, Inc. Catheter with extensible, two-piece needle guard
US6972002B2 (en) * 2000-04-28 2005-12-06 Specialized Health Products, Inc. Passively activated safety shield for a catheter insertion needle
US6997902B2 (en) * 2003-11-13 2006-02-14 David L. Thorne Safety shield for medical needles
AU2005326534A1 (en) * 2005-02-03 2006-08-10 Douglas Arthur Emmott A safety needle
US7189217B2 (en) * 2005-02-22 2007-03-13 Joseph Jawshin Chang Skin puncture device with needle stick protection
US7658725B2 (en) * 2006-02-16 2010-02-09 Smiths Medical Asd, Inc. Enclosed needle device with duckbill release mechanism
JP4211858B2 (en) * 2006-06-30 2009-01-21 ニプロ株式会社 Indwelling needle with wings

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4380234A (en) * 1979-08-16 1983-04-19 Baxter Travenol Laboratories, Inc. Infusion needle attachment
JP2910915B2 (en) * 1995-03-07 1999-06-23 ベクトン・ディキンソン・アンド・カンパニー Assembly of catheter and needle introducer with needle retraction device
US5643216A (en) * 1995-06-08 1997-07-01 White; James E. Patient bracelet having catheter capture integrally formed therewith and methods of making the same
US7651481B2 (en) * 2004-12-30 2010-01-26 CareFusion 303 Inc. Self-sealing male connector device with collapsible body
CN101466431A (en) * 2006-05-22 2009-06-24 贝克顿·迪金森公司 Catheter assembly with tip shield closure

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JP第2910915号B2 1999.06.23

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CN102892457A (en) 2013-01-23
JP2014208293A (en) 2014-11-06

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