CA1162177A - Atraumatic blood access device valve - Google Patents

Atraumatic blood access device valve

Info

Publication number
CA1162177A
CA1162177A CA000379272A CA379272A CA1162177A CA 1162177 A CA1162177 A CA 1162177A CA 000379272 A CA000379272 A CA 000379272A CA 379272 A CA379272 A CA 379272A CA 1162177 A CA1162177 A CA 1162177A
Authority
CA
Canada
Prior art keywords
blood
valve chamber
access device
retaining element
passageway
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000379272A
Other languages
French (fr)
Inventor
Donald A. Raible
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bentley Laboratories Inc
Original Assignee
Bentley Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bentley Laboratories Inc filed Critical Bentley Laboratories Inc
Priority to CA000439344A priority Critical patent/CA1172616A/en
Application granted granted Critical
Publication of CA1162177A publication Critical patent/CA1162177A/en
Expired legal-status Critical Current

Links

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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0261Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/027Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or septum
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0276Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing or removing fluids into or out of the body

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Abstract

ABSTRACT

A valving mechanism for use within a blood passage-way of a blood access device. The valving mechanism includes a plugging means and a valve chamber for receiving the plugging means when it is removed from its seat in the blood passageway. The valving mechanism also includes a retaining element adapted to slidably engage the valve chamber and an external rim of the blood access device for securing the valve chamber and blood access device. When the valve chamber is not in use, a retaining cap and retaining cap ring are used to secure the plugging means within the blood access device passageway.

Description

~ 162~77 ATRAUMATIC ~LOOD ACCESS DEVICE VALVE

The present invention relates to a blood access device and its method of implantation.
There are a number of situations in which it is necessary to provide for fluid communication with the vascular system.
For example, patients suffering from kidney failure require the dialysis of their blood by means external from the body.
Blood containing toxic substances, such as urea, uric acid, creatine, phosphorus and calcium, must be removed from the blood system, treated and then returned to the patient.
Patients requiring such blood dialysis need treatment at least two or three times per week. Patients suffering from hypoalimentation require a device for providing access to the body's vascular system on at least a daily basis.
One prior method of providing fluid communication with the vascular system involved the insertion of a needle into an artery from which blood to be treated was taken, and the insertion of a needle into a patient's vein for blood return. Such a method proved unsatisfactory due to the difficulty in providing for the healing of the artery upon removal of the needle and the trauma produced by the repeated needle insertions. Such shortcomings led to the development of external, and later, internal shunts. An external shunt involves the insertion of tubes, such as those made of Teflon (trademark), into an artery and an adjacent vein in a limb and providing an external communication or shunt between the tubes, which extends
-2-1 1~2177 from the body of the patient. The shunt between the tubes is required in order to provide flow through the tubes during that period of time that access is not required for blood treatment. Were such circulating blood flow not provided, a blood clot or thrombus could form, as would be the case if the tubes were simply capped, creating a static blood volume when the tubes were not in use. Dialysis, for e~ample, i8 accomplished by connecting the arterial and venous tubing to a 10 suitable dialysis unit. Such an external shunt config-uration traumatizes the skin adjacent the Teflon tubes and a path is provided through the skin for infection to enter the patientls body. Furthermore, even with external shunts, blood clots sometimes form within the tubes and create a health hazard to the patient.
The disadvantages of external shunts led to the development of the internal shunt. An internal shunt is performed by joining, within a body, openings between an 20 artery and an adjacent vein. The pressure in the artery being substantially greater than that in the vein causes the vein to become distended, forming a fistula. One or two needles are then inserted into the fistula in order to achieve communication with the patient's vascular system. The patient suffers major discomfort and pain each time the needles are inserted into the fistula.
Moreover, the continuous insertions into the fistula cause it to become layered with scar tissue which ultimately prevents further intrusion, thus requiring 30 the formation of another shunt.

~ 162177 Both the internal and external shunts increase the loading on the patient's heart due to the joining of the artery to a vein having a lower pressure, thereby lowering the artery's pressure, and requiring the heart to attempt to regain the original arterial blood pressure. Further, in many cases, the reduced circulation in the distal portion of the limb wherein the shunt is effected impairs the adequate removal of waste products from the muscles and other tissues resulting in weakness of the limb.
An object of the present invention is to provide an atraumatic valve for a blood access device. Other objects and advantages of this invention will become apparent upon a reading of the entire specification, including the drawings and clai.ms.
According to one aspect of the invention there is provided an atraumatic valving mechanism for operation within a blood passageway of a blood access device having an external rim, said blood passageway adapted to connect a blood vessel within a body to the body exterior, said valving mechanism comprising: a plugging means for sealing said blood passageway;
a reciprocable stem member means for connection to said plugging means; a valve chamber means adapted to be secured to the portion of said blood access device blood passageway at said body exterior, said valve chamber including an aperture through which said reciprocable stem member means for connection to said plugging means may be passed and; a retaining element and a retaining element ring for engaging therewith for securing said valve chamber means to said blood access device, said retaining element having an aperture for slidably engaging said valve chamber and a restraining shoulder for engaging said blood access device external rim and forcing, from opposed directionsJ
said valve chamber and blood access device together upon engaging said retaining element and retaining element ring.
According to another aspect of the invention there is provided an atraumatic valving mechanism for operation within a blood passageway of a blood access device, said blood passageway adapted to connect a blood vessel within a body to the body exterior, said valving mechanism comprising:

.~

a plugging means for sealing said blood passageway; a reciprocable stem member means for connection to said plugging means; a valve chamber means adapted to be secured to the portion of said blood access device blood passageway at said body exterior, said valve chamber including a valve chamber shoulder and an aperture through which said reciprocable stem member means for connection to said plugging means may be passed and; a retaining element and a retaining ring for engaging therewith, securing said valve chamber means to said blood access device, said retaining element ring having a member for engaging said valve chamber shoulder and forcing said valve chamber and said blood access device together upon engaging said retaining element and retaining element ring.
According to a further aspect of the invention there is provided an atraumatic valving mechanism for operation within a blood passageway of a blood access device, having an external rim, said blood passageway adapted to connect a blood vessel within a body to the body exterior, said valving mechanism comprising: a plugging means for sealing said blood passageway;
a reciprocable stem member means for connection to said plugging means;
a valve chamber means adapted to be secured to the portion of said blood access device blood passageway at said body exterior, said valve chamber including a blood outlet, a valve chamber shoulder, and an aperture through which said reciprocable stem member means for connection to said plugging means may be passed and; a retaining element and a retaining ring for engaging therewith securing said valve chamber means to said blood access device, said retaining element having an aperture for slidably engaging said valve chamber and a restraining shoulder for engaging said blood access device external rim and said retaining element ring having a member for engaging said valve chamber shoulder, thereby forcing, in opposed directions on either side of said external rim, said valve chamber and said blood access device together upon engaging said retaining element and retaining element ring Figure 1 is a side view in partial cross-section, illustrating the present invention, Figures 2 is a cross-sectional view taken about 2-2 3f Figure l;
Figures 3, 4, 5 and 8 are pictorial views i~lustrating a portion of the present invention; and Figures 6 and 7 are side views, in partial cross-section, illustrating the present invention.
Referring now to Figure 1, the blood access device within which the atraumatic valving mechanism of this invention operates, will be discussed. The blood access device, generally referred to as l, includes a blood passageway 3 having an external rim or lip 7, an anchor flange 15 and a flange means 5. The flange means 5 is secured to a blood vessel 13 by means of suitable surgical suture fiber 11.
Figure 1 further illustrates the use of vascular grafting material 19 which both provides for the minimizing of blood loss during implantation surgery and provides structural support for tissue ingrowth which allows the blood vessel 13 and body tissues to be securely anchored to the blood access device 1. In a preferred embodiment the vascular grafting material is made o a Dacron, or a like fabric, and is impregnated with collagen.
Figure 7 illustrates a patient's skin 18, fat 20, fascia 22 and muscle 24 within which the blood access device 1 is anchored. A plugging means 31 is shown positioned within the blood passageway 3 of the blood access device 1 and is adapted to prevent blood flow therethrough and to expel blood from the blood passageway 3 upon insertion. The blood passageway is preferably tapered as illustrated in Figure 1~ the taper having an untapered portion along its tapered length as shown as a vertical ring 38 in Figure 1 in order to provide an improved seal between the plugging means 31 and the blood passageway 3. The plugging means 31 is preferably restrained within the blood passageway , <~

1 1621~7
3 by means of a cap means 33 having a slot 34 at the top thereof and a threaded retaining ring 35. As shown in Figures 7 and 8, the retaining ring 35 is provided with an aperture 36 and a restraining shoulder 38 for sliding onto blood access device 1 and engaging external rim or lip 7 for a secure seal. As retaining ring 35 is threaded onto cap means 33, the base 40 of cap means 33 engages the upper portion 42 of external ring 7 and its restraining shoulder 38 engages the lower portion 44 of 10 the external rim in an opposing direction.
Having briefly described the blood access device with which the subject matter of this invention is utilized, the valving mechanism of this invention will now be more fully discussed.
When it is desired to remove blood from a patient's vascular system, restraining ring 35 is unthreaded, thereby allowing cap means 33 to be removed. A connec-tor or valve chamber generally referred to as 51 may be positioned about the external rim or lip 7 of the blood 20 access device 1 and retained in such a position by retaining element 83. The valve chamber 51 is prefer-ably provided with an engaging lip 53 which mates with ring 7 of the blood access device 1.
In accordance with this invention, plugging means 31 is provided with an internally threaded aperture 55 adapted to engage the threaded portion 57 of a recipro-cable stem member 59. The valve chamber 51 is further provided with a cavity portion 65 adapted to receive at least a portion of the plugging means 31 when said stem 30 member 59 and connected plugging means 31 are pulled ~ ~B2177 from said blood passageway 3 so as to allow blood flow from the blood vessel 13 through the blood passage-way 3.
The retaining element 83 i5 provided with an aper-ture 84 which allows the retaining element to slide into place about the valve chamber 51. The retaining element 83 further includes external threads 85 and a restraining shoulder 87 adapted to engage external rim 7 of blood access device 1. Restraining element 10 ring 89 is adapted to engage the shoulder 52 of valve chamber 51 with retaining ring member 93. Internal threads 91 of retaining ring 89 allow for the vice-like securing of the valve chamber 51 to blood access device 1. As the retaining element ring 89 is threaded onto retaining element 83, as illustrated in Figure 1, retaining ring member 93 bears down on valve chamber shoulder 52 and restraining shoulder 87 exerts an opposing upward force on the external rim on lip 7 of the blood access device 1.
Reciprocable stem member 59 includes an annular slot 60 which corresponds to the top of the valve chamber 51 when the reciprocable stem 59 is withdrawn in order to open the blood access device valves as shown in Figure 6.
When the reciprocable stem member 59 is in such position, the slotted aperture 62 of tool 63 can be positioned about annular slot 60 in order to lock the reciprocable stem member in the open position. The opposed end 64 of the tool 63 is adapted to engage slot 34 of cap means 33 in order to assist in securing or removing the cap means 30 33.

While the preferred embodiments and the application of this invention have been shown and described, it will be apparent to those skilled in the art that modifica-tions thereto may be made without departing from the inventive concepts herein described. The invention is, therefore, to be limited only by the scope of the claims appended hereto.

Claims (10)

The embodiments of the invention in which an exclu-sive property or privilege is claimed are defined as follows:
1. An atraumatic valving mechanism for operation within a blood passageway of a blood access device having an external rim, said blood passageway adapted to connect a blood vessel within a body to the body exterior, said valving mechanism comprising:
a plugging means for sealing said blood passageway;
a reciprocable stem member means for connection to said plugging means;
a valve chamber means adapted to be secured to the portion of said blood access device blood passageway at said body exterior, said valve chamber including an aperture through which said reciprocable stem member means for connection to said plugging means may be passed and;
a retaining element and a retaining element ring for engaging therewith for securing said valve chamber means to said blood access device, said retaining element having an aperture for slidably engaging said valve chamber and a restraining shoulder for engaging said blood access device external rim and forcing, from opposed directions, said valve chamber and blood access device together upon engaging said retaining element and retaining element ring.
2. The atraumatic valving mechanism claimed in claim 1 wherein:

said stem member is further defined as having a threaded portion adpated to be inserted within an inter-nally threaded portion of said plugging means.
3. The atraumatic valving mechanism claimed in claim 1 wherein:
said valve chamber includes a blood inlet and a blood outlet.
4. An atraumatic valving mechanism for operation within a blood passageway of a blood access device, said blood passageway adapted to connect a blood vessel within a body to the body exterior, said valving mechanism comprising:
a plugging means for sealing said blood passageway;
a reciprocable stem member means for connection to said plugging means;
a valve chamber means adapted to be secured to the portion of said blood access device blood passageway at said body exterior, said valve chamber including a valve chamber shoulder and an aperture through which said reciprocable stem member means for connection to said plugging means may be passed and;
a retaining element and a retaining ring for engaging therewith, securing said valve chamber means to said blood access device, said retaining element ring having a member for engaging said valve chamber shoulder and forcing said valve chamber and said blood access device together upon engaging said retaining element and retain-ing element ring.
5. The atraumatic valving mechanism claimed in claim 4 wherein:
said stem member is further defined as having a threaded portion adapted to be inserted within an internally threaded portion of said plugging means.
6. The atraumatic valving mechanism claimed in claim 1 wherein:
said valve chamber further includes a blood inlet and a blood outlet.
7. An atraumatic valving mechanism for operation within a blood passageway of a blood access device, having an external rim, said blood passageway adapted to connect a blood vessel within a body to the body exterior, said valving mechanism comprising:
a plugging means for sealing said blood passageway;
a reciprocable stem member means for connection to said plugging means;
a valve chamber means adapted to be secured to the portion of said blood access device blood passageway at said body exterior, said valve chamber including a blood outlet, a valve chamber shoulder, and an aperture through which said reciprocable stem member means for connection to said plugging means may be passed and;
a retaining element and a retaining ring for engaging therewith securing said valve chamber means to said blood access device, said retaining element having an aperture for slidably engaging said valve chamber and a restraining shoulder for engaging said blood access device external rim and said retaining element ring having a member for engaging said valve chamber shoulder, thereby forcing, in opposed directions on either side of said external rim, said valve chamber and said blood access device together upon engaging said retaining ele-ment and retaining element ring.
8. The atraumatic valving mechanism claimed in claim 7 wherein:
said stem member is further defined as having a threaded portion adapted to be inserted within an internally threaded portion of said plugging means.
9. The atraumatic valving mechanism claimed in claim 7 wherein:
said valve chamber further includes a blood inlet and a blood outlet.
10. The atraumatic valving mechanism claimed in claim 8 wherein said threaded portion adapted to be inserted within said internally threaded portion of said plugging means includes a slot corresponding to the outer surface of said valve chamber when said plugging means is disengaged from said blood access device, thereby allowing blood flow therethrough for locking said plugging device in such disengaged position.
CA000379272A 1980-06-09 1981-06-08 Atraumatic blood access device valve Expired CA1162177A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA000439344A CA1172616A (en) 1980-06-09 1983-10-19 Atraumatic blood access device valve

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US158,063 1980-06-09
US06/158,063 US4349021A (en) 1980-06-09 1980-06-09 Atraumatic blood access device valve

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA000439344A Division CA1172616A (en) 1980-06-09 1983-10-19 Atraumatic blood access device valve

Publications (1)

Publication Number Publication Date
CA1162177A true CA1162177A (en) 1984-02-14

Family

ID=22566546

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000379272A Expired CA1162177A (en) 1980-06-09 1981-06-08 Atraumatic blood access device valve

Country Status (7)

Country Link
US (1) US4349021A (en)
JP (1) JPS57500866A (en)
CA (1) CA1162177A (en)
FR (1) FR2483784B1 (en)
GB (4) GB2088218B (en)
IT (1) IT1136663B (en)
WO (1) WO1981003425A1 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4421507A (en) * 1980-12-24 1983-12-20 Carbomedics, Inc. Plug-type fluid access devices
FR2561922B1 (en) * 1984-04-02 1987-04-30 Biomasys DEVICE FOR ATRAUMATIC ACCESS TO THE BLOOD CIRCUIT
US4639247A (en) * 1984-11-02 1987-01-27 Carbomedics, Inc. Percutaneous access device
US5788215A (en) * 1995-12-29 1998-08-04 Rymed Technologies Medical intravenous administration line connectors having a luer or pressure activated valve
US5833213A (en) * 1995-12-29 1998-11-10 Rymed Technologies, Inc. Multiple dose drug vial adapter for use with a vial having a pierceable septum and a needleless syringe
US5954313A (en) * 1995-12-29 1999-09-21 Rymed Technologies, Inc. Medical intravenous administration line connectors having a luer activated valve
US7618410B2 (en) 2004-10-05 2009-11-17 Cardia Access, Inc. Devices and methods for access through a tissue wall
WO2009033177A1 (en) * 2007-09-07 2009-03-12 Imtec, Llc Method and device for dialysis
US20100152640A1 (en) * 2008-09-05 2010-06-17 Imtecbiomedical, Inc. Methods and apparatus for vascular access
EP2575951B1 (en) * 2010-06-04 2015-10-07 Cendres + Métaux SA Implanted access port
US9333331B2 (en) 2010-11-08 2016-05-10 Cendres+Metaux Sa Method for implanting an access port
EP2859911A1 (en) 2013-10-11 2015-04-15 qSTAR Medical SAS Vascular access port devices with incorporated sensors

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL7202310A (en) * 1971-03-01 1972-09-05
US4015601A (en) * 1975-10-14 1977-04-05 General Atomic Company Blood access device
US4092983A (en) * 1977-01-31 1978-06-06 General Atomic Company Blood access device
US4108173A (en) * 1977-04-11 1978-08-22 General Atomic Company Blood access device
US4164221A (en) * 1977-07-28 1979-08-14 Bentley Laboratories, Inc. Atraumatic blood access device valve
GB2000977B (en) * 1977-07-07 1982-07-14 Bentley Lab Blood access devices and methods of implantation
DE2948949A1 (en) * 1979-08-15 1981-03-26 American Hospital Supply Corp., Evanston, Ill. IMPLANTATION ELEMENT
US4350157A (en) * 1980-06-03 1982-09-21 Bentley Laboratories Atraumatic blood access device valve

Also Published As

Publication number Publication date
GB2088218A (en) 1982-06-09
GB2088218B (en) 1985-07-03
GB8404194D0 (en) 1984-03-21
GB2142828B (en) 1985-07-24
IT8122198A0 (en) 1981-06-09
JPS57500866A (en) 1982-05-20
GB8419075D0 (en) 1984-08-30
FR2483784A1 (en) 1981-12-11
WO1981003425A1 (en) 1981-12-10
GB8419074D0 (en) 1984-08-30
US4349021A (en) 1982-09-14
FR2483784B1 (en) 1986-10-24
IT1136663B (en) 1986-09-03
GB2142828A (en) 1985-01-30

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