US3826256A - Catheter delivery device - Google Patents

Catheter delivery device Download PDF

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US3826256A
US3826256A US00217468A US21746872A US3826256A US 3826256 A US3826256 A US 3826256A US 00217468 A US00217468 A US 00217468A US 21746872 A US21746872 A US 21746872A US 3826256 A US3826256 A US 3826256A
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catheter
passageway
lumen
feeding nose
feeding
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US00217468A
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G Smith
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Medidyne Corp
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Medidyne Corp
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    • 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
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0122Steering means as part of the catheter or advancing means; Markers for positioning with fluid drive by external fluid in an open fluid circuit

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  • ABSTRACT In a device for ejecting a catheter into a passageway like a blood vessel, the device including a housing containing a catheter extending or extendable into a feeding nose, such as a cannulated needle, the housing interior to be fluid pressurized to effect fluid flow around the catheter.
  • the catheter is inwardly compressible and of a size where the outer diameter is about equal to and preferably somewhat greater than the inner diameter of the needle lumen.
  • the build-up of fluid pressure within the housing of the device was found to compress the catheter making it of a smaller diameter than the needle lumen and in the process forming, at least during the initial stages of catheter movement, 'a catheter with a piston-like profile so that the catheter is impelled by fluid friction and piston acmen.
  • CATHETER DELIVERY DEVICE This invention relates to a catheter delivery device which incorporates the invention of and is an improvement over the catheter delivery devices disclosed in my application Ser. No. 54,732 entitled METHOD AND APPARATUS FOR CATHETER INJECTION filed July 14, 1970.
  • the catheter injection devices disclosed in this application and the catheter device which is the subject of the present invention utilize the build-up of fluid pressure in a catheter housing having a feeding nose for guiding the catheter, to cause the flow of fluid between the catheter and the inside wall of the feeding nose (which may be a cannulated needle) to inject the catheter within a body passageway such as a blood vessel.
  • the catheter material is most advantageously very limp to minimize irritation of the blood vessel walls and to enable the catheter readily to follow irregular paths within the blood vessel.
  • the catheter diameter it is desirable to make the outside diameter of the catheter as close as possible to the outer diameter of the needle through which it passes, so that upon removal of the needle after catheter injection, the skin, blood vessel wall and other tissue punctured by the needle will contract as tightly as possible around the catheter to minimize leakage of fluid around the catheter. ldeally, therefore, although limitations on the operation of catheter delivery devices heretofore was thought to mitigate against the same, it would be desirable for the catheter diameter to be equal to and even greater than the diameter of the defining walls of the needle lumen'through which it is guided into a blood vessel or other passageway.
  • catheters placed in body passageways, like blood vessels, using the lumen of a cannulated needle or other feeding nose as an exterior guiding means were always of a size smaller than the lumen of the guiding means, so that the catheter can freely slide or pass through the lumen.
  • the friction between the catheter and the lumen would be such that the catheter could not be advanced through the lumen of the guiding means.
  • the present invention for a given needle size, a larger catheter can be ejected from the needle than was thought heretofore possible and greater catheter ejection velocities are obtained for a modest increase in fluid pressure making catheter injection more effective, especially in circumstances when the catheter must be ejected substantial distances through irregular paths within blood vessels and the like. Moreover, the present invention has substantially reduced the reject ratios to a point where practically all manufactured catheter delivery devices are operable in ejecting their catheters with appreciable velocities.
  • the present invention is based on my discovery that where an elastic catheter which is compressible is utilized, most preferably one made of a soft, very pliable rubber-like material having the limp resilient and inert quality of a silicone elastomer and the outer diameter of the catheter is made at least about equal to at least the minimum diameter of the needle lumen (i.e.
  • some needle lumens have a variation in diameter) and preferably at least equal to or, even better, slightly larger than the diameter of the entire length of a needle lumen, where it would be assumed that the fit between the catheter and defining walls of the needle lumen would prevent any catheter ejection, the catheter is actually ejected at a higher velocity'and more readily for a modest increase in manual force applied to a squeeze bulb or the like than in the case where a small but finite clearance was provided as described above.
  • the fluid pressure within the catheter delivery device housing was instrumental in compressing the catheter so that the catheter within the needle lumen is very closely spaced from the walls of the needle lumen during the application of the fluid pressure. Also, for a given pressure, a greater velocity of fluid flow results in the very small clearance between the catheter and needle lumen walls which increases the fluid shear forces acting on the catheter.
  • the pressure acting on the catheter is believed to provide, during at least the initial catheter ejection operation, a forwardly and outwardly flaring profile which provides a rearwardly facing shoulder against which the force of fluid ejected from the needle lumen is applied to substantially increase the ejection force on the catheter.
  • the junction between the initially compressed and uncompressed portions of the catheter is not an abrupted right angled juncture, but is a gradually forwardly and outwardly flaring portion which has both radially outwardly and rearwardly facing components, so that there is a surface against which the pressure can act to compress the same radially inwardly.
  • the aforementioned forwardly and outwardly flaring profile of the catheter, which initially is located at the point where the catheter first enters the needle lumen of the same or smaller size, under the application of fluid pressure is caused to progressively move down the length of the catheter toward the front of the needle.
  • the entire catheter leaves contact with the needle lumen at the end of the needle lumen where the fluid pressure on the catheter is greatly reduced permitting the catheter to expand at this point to its initial size.
  • the catheter then has a piston-like profile at the end of the needle lumen and also, it is believed, an outwardly flaring profile within the needle lumen and so presents rearwardly facing surfaces against which the moving fluid applies a force to aid in catheter ejection.
  • the catheter is free to be impelled by both the increased frictional forces of the flow of fluid which then begins around the catheter and also by the force of the fluid flow against the rearwardly facing component of the catheter profile.
  • the catheter delivery device is manufactured in a state where it has to be subsequently filled with a sterile liquid like saline solution or other liquid.
  • a sterile liquid like saline solution or other liquid.
  • the small head pressures which are normally present are insufficient to overcome the opposition to compression of the catheter for normal catheter lengths (e.g. 9 inches) and some air remains trapped within the device which is expelled when the catheter is impelled by the liquid moving around the catheter.
  • the catheter utilized is made of an unusually long length which length depends upon the inside diameter of the catheter so that the pressure drop occurring when the liquid rises in the catheter is so substantial at the point where the catheter contacts the needle lumen walls that even a few feet of head pressure is sufficient to compress the catheter to permit liquid and air to pass air around the catheter.
  • the catheter is of a more common length, such as 9 inches, a similar result is achieved by forming a partial obstruction at the rear of the catheter which effects a substantial pressure drop or hinderance to liquid flow at this point, so that in effeet a similar pressure drop is present at the points where the catheter makes contact with the needle lumen walls.
  • the catheter injection device is provided with its own valve so that at any desirable time the device can be charged with a sterile liquid and disconnected from the source of liquid and be ready immediately to be used where the catheter injection operation is desired.
  • Another feature of the invention relates to an improved infusion liquid-receiving adapter assembly carried on the feeding nose of a catheter delivery device and which can easily be pulled from the feeding nose together with the rear end portion of an ejected catheter temporarily held in the feeding nose lumen, and then sealingly related to the released end of the catheter.
  • FIG. 1 illustrates an initially liquid-free catheter delivery device in its packaged condition
  • FIG. 2 is a longitudinal, sectional view through the catheter delivery device shown in FIG. 1, after it is removed from the package;
  • FIG. 3 is an enlarged, longitudinal, sectional view through the rear end portion of the catheter delivery device of FIG. 2, taken along section line 3-3 therein;
  • FIG. 4 is an enlarged, transverse, sectional view through the rear end portion of the catheter delivery device of FIG. 2, taken along section line 4-4 therein;
  • FIG. 5 is an enlarged, transverse, sectional view through the front end portion of the catheter delivery device shown in FIG. 2, taken along section line 5-5 thereof;
  • FIG. 6 is a view showing the catheter delivery device of FIGS. 1-5 connected to an infusion bottle assembly for filling the delivery device with liquid and oriented to expunge air therefrom;
  • FIG. 7 is a transverse sectional view of that portion of the rear end of the catheter delivery device shown in FIG. 4 when the portion shown in squeezed to open the check valve formed thereby;
  • FIG. 8 is an enlarged, fragmentary, longitudinal, sectional view through the front end portion of the catheter delivery device of FIGS. l-4 during the time air is being expunged therefrom;
  • FIG. 9A is a greatly enlarged, fragmentary, longitudinal sectional view of the front and rear end portions of the catheter containing portions of the catheter delivery device of FIGS. l-8 after having been filled with liquid and prior to the application of fluid pressure within the same and when the catheter has a diameter equal to the diameter'of the main portion of the needle lumen;
  • FIG. 9B is a longitudinal, sectional view corresponding to FIG. 9A during the instant when fluid pressure has been applied to the fluid within the catheter delivery device of FIG. 9A but prior to the bodily movement of the catheter from the catheter delivery device;
  • FIG. 9C is a longitudinal, sectional view corresponding to FIGS. 9A and 98 at the moment the catheter within the device has a configuration where the flow of fluid is impelling the same from the needle thereof;
  • FIG. 91 is a longitudinal sectional view of the base portion of the needle and the enlarged rear end portion of the catheter frictionally locked within the base of the needle after completion of a catheter ejection operation;
  • FIG. 10A is a greatly enlarged, fragmentary, longitudinal, sectional view of the front and rear end portions of the catheter containing portions of the catheter delivery device of FIGS. l-8 after having been filled with liquid and prior to the application of fluid pressure within the same, and when the catheter has a diameter just equal to the diameter of the narrow swaged point of the needle lumen;
  • FIG. 10B is a longitudinal, sectional view corresponding to FIG. 10A during the instant when fluid pressure has been applied to the fluid within the catheter delivery device of FIG. 9A but prior to the bodily movement of the catheter from the needle thereof;
  • FIG. 10C is a longitudinal, sectional view corresponding to FIGS. 10A and 108 at the moment the catheter within the device has a configuration where the flow of fluid is impelling the same from the catheter delivery device;
  • FIG. 11 is a greatly enlarged view of the front end portion of the catheter containing portions of the catheter delivery device of FIGS. 1-8 after having been filled with liquid and prior to the application of fluid pressure within the same, and when the catheter has a diameter greater than that of the main portion of the needle lumen;
  • FIG. 12 is an enlarged, longitudinal, sectional view of the depressible bulb-like portion of the catheter delivery devices of FIGS. l-ll after the bulb-like portion has been fully compressed to eject the catheter from the catheter delivery device;
  • FIG. 13 is a view showing the separation of the assembly of the end of the catheter, infusion liquidreceiving adapter and associated sleeve from the needle and the attached tubing;
  • FIG. 14 is a longitudinal, sectional view of the catheter and the infusion-receiving adapter after the catheter has been fully pulled into interlocking relationship with the adapter and the adapter attached to the complimentary connector of an infusion bottle assembly shown in FIG. 6;
  • FIG. 15 is a partially sectional view though a moditied form of catheter delivery device which includes a unique infusion liquid-receiving adapter construction
  • FIG. 16 is a fragmentary longitudinal sectional view through the adapter holding portion of the catheter delivery device of FIG. 15 taken along section lines 16-16 therein;
  • FIG. 17 is a fragmentary, longitudinal, sectional view showing the front portion of the catheter delivery device in FIG. 15 with the catheter injected into a blood vessel and the needle withdrawn from the blood vessel and in the process of being pulled over the catheter and through the infusion liquid-receiving adapter;
  • FIG. 18 is a partly broken away viewv of the remaining portion of the infusion liquid-receiving adapter and catheter of FIG. 17 after separation from the needle, portions of the adapter have been discarded, the catheter has been pulled securely into interlocking relationship with the remaining portion of the adapter, and the adapter taped to the patients body;
  • FIG. 19 is a transverse sectional view through the taped remaining portion of the adapter of FIG. 18, taken along section line 19-19 thereof.
  • an embodiment of the catheter delivery device of the invention identified by reference number 1 is shown initially packaged in a sterilized state in a suitable transparent package or container 2 in which the device may be sterilized in a conventional way.
  • the catheter delivery device 1 as illustrated is designed for injecting a catheter 3 through a cannulated needle 4 or the like into a blood vessel.
  • the catheter delivery device 1 as illustrated is designed for injecting a catheter 3 through a cannulated needle 4 or the like into a blood vessel.
  • the catheter delivery device 1 includes a catheter containing body assembly 6 comprising a main tubular body portion 6a which may be made of a suitable transparent synthetic plastic tubing.
  • the rear end of the tubing terminates in a laterally extending bulb-like portion 6b, also made of a synthetic plastic material, which is the fluid pressure applying means of the catheter injection device 1. (However, other fluid pressure applying means could be used in the present invention other than bulb-like portion.)
  • the cannulated needle 4 is connected to the front end of the tubing 6a by a hollow needle hub 8 which is somewhat larger than the tubing 60 and over which hub the tubing is securely anchored.
  • the needle 4 is anchored within the hub 8.
  • the lumen 4a of the needle 4 forms a continuation of an open-ended passageway 14 within the tubing 6a.
  • the catheter 3 has an intermediate portion 30 extending through the passageway 14 and a front end portion 3b extending part way into the needle 4. Where the length of catheter desired is longer than the distance between the bulb-like portion 6b of the catheter containing body assembly 6 and a point near the forward end of the needle, the intermediate portion 3a of the catheter 3 terminates at the rear thereof in a coiled portion 3c confined in a neatly coiled relation by the walls of the bulb-like portion 6b.
  • the bulb-like portion 6b is most advantageously a member having a dome-shaped depressible wall 15 (FIG. '12).
  • the tubing 6a has a rear end portion which extends within a tubular extension of the cylindrical wall 17 where the tubing communicates with a chamber 22 within the bulb-like portion 6b.
  • a short compressible tubular section 24 extends rearwardly from the bulb-like portion 6b and has a passageway 18 communicating with the chamber 22 and forming at the end thereof a portion 180 for snugly receiving a connector 23 at the end of an infusion bottle assembly 26 (FIG. 6) or other source ofa sterile liquid like saline solution.
  • the tubular section 24 has friction fitted in the front end portion of the passageway 18 a plug or pinch valve-forming member 21 which closes the passageway 18.
  • the member 21 has a forwardly extending pin-like projection 21a (FIG. 3) over which the rear end portion 3d of the catheter most desirably loosely extends to form a plug or hinderance to fluid flow through the catheter.
  • the pinching of the tubular section 24 elongates the cross-section thereof as shown in F IG. 7 to form openings on opposite sides of the check valve-forming member for passage of fluid into the catheter delivery device.
  • the dome-shaped wall 15 When the dome-shaped wall 15 is depressed, it preferably snaps into an inverted shape as shown in FIG. 12, so that once the bulb is fully compressed, the depressed wall 15 remains collapsed. However, if the wall 15 is only slightly depressed and released, it returns to its initial position. Such slight depression of the wall 15 is sometimes carried out after the needle has been apparently placed in a blood vessel as an aid in drawing some blood into the catheter delivery device which, if visible through the transparent portions of the device, indicates that the needle tip is located in a blood vessel.
  • the end of the needle 4 carries a preferably transparent synthetic plastic needle cover 25 best shown in FIG. 8 having an opening 250 at the front end thereof.
  • the needle cover has fixed therein a long catheter holding member 27 which extends into the front end portion of the needle lumen 4a to prevent movement of the catheter from the needle when air is flushed from the device.
  • the catheter holding member 27, as illustrated, has a flat shank portion 27a frictionally held in the needle cover and terminates in a head portion 2712 outside of the needle cover.
  • the needle cover 25 has a front cylindrical portion 25b defining a corresponding cylindrically shaped passageway 25c therein, the defining walls of which snugly engage the needle 4.
  • the needle cover 25 has a rearwardly outwardly flaring portion 25d which engages around the front end portion of an infusion liquid-receiving adapter member 29 which is used to make connection to the connector 23 of an infusion bottle assembly 26 shown in FIG. 6 after ejection of the catheter from the catheter delivery device 1.
  • the flat profile of the shank portion 27a of the catheter holding member forms clearance spaces through which air and liquid can pass through the needle lumen 4a in front of the catheter and the opening 250 at the front end of the needle cover after flowing between the catheter and the needle lumen in a manner to be described.
  • the needle cover 25 and the catheter holding member 27 carried thereby are removed together as a unit from the needle after air has been expunged from the catheter delivery device. (Manifestly, the needle cover 25 and the catheter holding member can have other configurations.)
  • the base portion of the needle 4 is initially tightly enveloped by the defining walls of a passageway 46 in the nose portion 30 of the infusion liquid-receiving adapter member 29 made of an expandable resilient plastic material which has a hollow cylindrical rear portion 31 which fits within the front end of a sleeve 34 preferably made of a transparent synthetic plastic material.
  • the rear end of the sleeve 34 has a flanged end portion 35 with an opening 36 into a cylindrical space 39 within the sleeve 34.
  • the tubing 60 fits with a slide or loose fit into the rear sleeve opening 36.
  • the needle hub 8 secured to the front of the tubing 6a makes a slide frictional fit within the sleeve 34 and can be removed with the needle 4 from the sleeve by pulling the same rearwardly to separate it from the sleeve, as shown in F 1G.
  • the catheter 3 is made of a material which is completely inert to body fluids and tissue so it can remain indefinitely in the body passage involved and does not irritate such tissue.
  • the catheter should also be very limp and elastic and most desirably when it is to be coiled it should have a resiliency as well as the limpness of gum rubber or a well cooked wet noodle.
  • An example of what is meant by a limp and elastic catheter is one which has an elongation of 450 to 800 percent as determined by a STM test procedure P 412. Unlike gum rubber which is not inert to body fluids, a catheter material which has all these qualities is silicone elastomer.
  • the catheter 3 preferably has a two-step enlargement at the very rear end thereof, the first enlargement being identified by reference numeral 3d and the second enlargement being identified by reference numeral 3d" (FIG. 9A).
  • the pin-like projection 21a of the check valve-forming member 21 fits into the interior of the first enlargement 3d preferably loosely but sufficiently close to the catheter walls to reduce the opening therein to a size where liquid cannot readily enter the same, causing a substantial pressure drop when fluid tries to flow therethrough. For example, a clearance of about 0.002 inch was found to be satisfactory in one case. As shown in FIG.
  • the outer diameter of the first enlargement 3d is somewhat greater than the inner diameter of the needle lumen 4a and joins the portion of the catheter in front of the same by a forwardly tapered portion 41 so that when catheter ejection is initiated and the first enlargement reaches the needle lumen 4a, the tapered part will become wedged in the needle lumen 4a and reduce the catheter clearance to zero.
  • the wedging of the tapered portion 41 of the first enlargement 3d of the need] lumen 4a prevents any backward movement of the catheter which could bring the catheter against the sharp end of the needle to sever the catheter.
  • the enlargements 3d and 3d of the catheter are of such a length and thickness that by pulling on the catheter 3 the enlargements will distend in length and contract in diameter so the catheter can be readily pulled through the needle 4.
  • the needle hub can have a variety of constructions, as shown, for example, in FIG. 9A, it has a flanged portion 8a from which extends a reduced forwardly projecting nose portion 8b defining a passageway 8b' into which the cylindrical cannulated needle 4 extends and is anchored as by swaging the nose portion therearound.
  • This forms a short inwardly projecting portion or constriction at 40' within the needle lumen which defines an opening or constriction in the needle lumen of less diameter than the rest of the needle lumen.
  • the needle hub further has a rearwardly projecting skirt portion 8c defining an inner cylindrical bore 80 of greater size than said nose portion passageway 8a and merging therewith through a tapered opening 8d.
  • the catheter enlargements 3d and 3d readily fit within the hub bore 8c.
  • the hub bore 80' communicates with the rear of the hub 8 through a flared entryway 8c".
  • the outer surface of the skirt is serrated at 45 to form a friction surface over which the tubing 6a snugly fits.
  • the connector 23 of the infusion bottle assembly 26 shown in FIG. 6 fits into an initially cylindrical opening 40 formed by the rear cylindrical portion 31 thereof.
  • the adapter member 29 is also provided with a recess 42 behind the nose portion 30 for receiving the second enlargement 3d of the catheter 3 after completion of catheter ejection and the removal of the adapter member and the catheter from the rest of the catheter delivery device in a manner to be explained.
  • the nose portion passageway 46 of the adapter member after removal from the needle contracts to a size smaller in size than the first enlargement 3d at the end of the catheter and into which such enlargement 3d is pulled and seals after catheter ejection.
  • the catheter delivery device 1 impels the catheter 3 by causing a relatively high velocity flow of fluid between the catheter and the defining walls of the needle lumen. This requires that at least during the time that the catheter is being ejected from the catheter delivery device the catheter 1 must be of a size and shape to pass freely through the needle lumen 4a.
  • catheter ejection is most effectively achieved by making the compressible catheter of an initial diameter such that it would not freely pass through the needle lumen unless the size thereof would reduced from its initial size, which is achieved by the compression of the catheter when fluid pressure is applied thereto.
  • the catheter is thus made of a diameter so that it makes initial engagement with the walls of the needle lumen 4a as, for example, shown in FIG. 9A.
  • the first step in using the catheter deliverly device 1 is to connect the catheter delivery device to a source of a sterile liquid like the infusion bottle assembly 26 shown in FIG. 6, by removing the device from the package 2 and connecting the rearwardly projecting tubular section 24 of the device to the connector 23 at the end of the infusion bottle assembly 26.
  • the catheter delivery device is then picked up and held so that the tip of the needle points upwardly, and a pinch clamp 46 of the infusion bottle assembly is released to permit infu sion liquid to pass to the connector 23.
  • the compressible tubular section 24 of the catheter delivery device is then squeezed to permit the infusion fluid to flow into the device until liquid flows through the opening 25a at the end of the needle cover 25 indicating that the air above the same has been expunged from the device.
  • the tubular section 24 is then released and disconnected from the infusion connector 23.
  • the liquid readily rises within the catheter delivery device and first fills the bulb-like portion 6b and pushes any air upwardly ahead of the same.
  • the fluid also enters the rear or bottom end of the catheter because it is only loosely obstructed by the pin-like projection 21a, to flush air from the catheter.
  • the compressible nature of the catheter and the lower pressure within the catheter resulting from the drop in fluid pressure as the liquid flows through the obstructed rear end of the catheter and the length of the catheter behind the point where the catheter enters the needle lumen enables the pressure caused by the pressure head of the infusion bottle system slightly to compress the catheter so the air and liquid can pass around the catheter and gain access to the clearance spaces between the shank portion 27a of the catheter holding member 27 and the upper or front end of the needle lumen and between the shank portion 27a of the catheter holding member 27 and the needle cover 25, ultimately passing through the opening 25a in the end of the needle cover.
  • the needle cover 25 and the catheter holding member 27 carried thereby are removed by pulling the same from the end of the needle 4.
  • the needle 4 is then inserted into the blood vessel involved and after a tourniquet has been applied in the usual manner for needle insertion, the depresssible wall 15 of the bulb-like portion 6b is fully depressed to inject the catheter 3 into the blood vessel involved.
  • FIGS. 9A through 93 the catheter 3 is shown as having a diameter equal to the diameter of the needle lumen 4a (and therefore somewhat greater than the diameter of the constricted portion of the needle lumen at 4a).
  • the constriction at 4a may be 0.003 inch less than the diameter of the rest of the needle lumen.
  • FIG. 9A illustrates the condition of the catheter delivery device 1 before application of pressure thereto.
  • This outwardly flaring portion exposes a small exterior portion of the catheter at the base of the needle lumen to which the fluid pressure is applied and this portion of the catheter is fully compressed to form another outwardly flaring portion immediately in front of the same. It can thus be seen that, upon initial application of fluid pressure, the portion of the catheter within the needle lumen becomesprogressively sively compressed until the entire length thereof leaves contact with the needle lumen walls. Then the flow of fluid is instrumental in effecting movement of the catheter from the needle lumen, and when the catheter reaches the outer end of the needle lumen, as shown in FIG. 9C, the catheter sharply expands to the diameter of the needle lumen.
  • the pressure conditions against the catheter vary somewhat along the length of the needle lumen from a point where it leaves the needle lumen where the pressure is a minimum and equal to the patients blood pressure to a point deeply within the lumen where a maximum pressure is realized.
  • There will, therefore, be a slightly progressive outward flaring of the catheter for its full length within the needle lumen even after it completely leaves contact with the needle lumen, and this outwardly flaring portion of the catheter as well as the more sharply outwardly expanding portion of the catheter as it leaves the needle lumen provides rearwardly facing surfaces against which liquid pressure is applied to form a piston-like action which cooperates with the force applied to the catheter by the friction of fluid flow therearound, to impart a greater impelling force to the catheter.
  • the present invention also includes the use of a catheter whose outer diameter is approximately equal to or slightly greater than the diameter of the constricted portion of the needle lumen at 4a and somewhat smaller than the remaining diameter of the needle lumen.
  • a catheter whose outer diameter is approximately equal to or slightly greater than the diameter of the constricted portion of the needle lumen at 4a and somewhat smaller than the remaining diameter of the needle lumen.
  • FIGS. 10A, 10B and 10C respectively show the condition of the catheter before application of fluid pressure, at the instant of initial application of fluid pressure and when the fluid pressure and resultant fluid flow has caused the catheter to leave the needle lumen. As shown in FIG.
  • the initial compression of the catheter instantaneously causes the catheter to lose contact with the constriction of the needle lumen and thereby provides a piston-like profile which is instantaneously instrumental in effecting movement of the catheter from the lumen as it provides a shoulder against which the fluid pressure propels the catheter forwardly along with the friction of the moving fluid against the sides of the catheter.
  • the present invention is also effective when the catheter is of a greater size than the diameter of the needle lumen for its full length, such as an oversize of 0.005 inch.
  • the catheter is not readily possible to mount the catheter within the needle lumen prior to the application of pressure to the catheter.
  • the front end of a preferably modified catheter 3 having preferably a beveled tip 53 in the needle hub bore 80' where there is preferably only the tapered surface 8d in front of the oversized catheter against which the catheter can strike.
  • the catheter Upon application of fluid pressure by depression of the bulb-like portion 6b, the catheter is guided into the needle lumen adjacent to which it is located and is compressed by the pressure conditions involved for the same reasons and in the same manner as shown in FIGS. 9A-9C.
  • the needle is withdrawn from the patient, the user grasps the flanged portion 35 of the sleeve 34 with one hand (usually the left hand) and pulls on the tubing 6a with the other hand to bring the needle hub 8 against a small shoulder 55 (FIG. 12) at the rear of the sleeve 34 where the tip of the needle is retracted within the infusion liquid-receiving adapter member 29.
  • the assembly of the adapter member 29, the sleeve and the catheter are held together as a unit by pinching the portion of the sleeve 34 around the adapter 29 with one hand which compresses the desirably compressible adapter around the catheter to hold the same in place while the tubing is pulled sharply with the other hand.
  • the sleeve 34 now acts like a catheter holding skirt by preventing the catheter from dropping upon contaminating surfaces.
  • the catheter is then pulled fully into the adapter member 29 where it is drawn into its extreme position therein, as shown in FIG. 14.
  • the sleeve 34 is pulled from the adapter member 29 and thrown away.
  • the rear cylindrical portion 31 of the adapter member 29 may then be connected to the connector 23 of the infusion bottle assembly 26.
  • FIGS. 15-19 illustrates a modification of the present invention involving, among other things, the elimination of the sleeve 34 which is primarily for the purpose of protecting the catheter when the catheter is pulled into position within the adapter member 29, and the inclusion of a modified infusion liquidreceiving adapter assembly 29.
  • the catheter 3" utilized is much longer than the catheters 3 previously described in that it is not necessary to use an obstruction like the plug-forming extension 21a in the open rear end of the catheter to reduce the pressure at the point where the catheter engages the needle lumen walls to an extent permitting the escape of air and fluid around the catheter under relatively small pressure head conditions. (The catheter 3" is, of course, fully impelled into the blood vessel involved and after catheter ejection would be withdrawn from the blood vessel an amount to leave the desired length of catheter in the blood vessel.)
  • the modified adapter assembly 29 in addition to simplifying the construction of the device by eliminating the sleeve 34, is that it permits a tighter fit between it and the enlarged rear end of the catheter 3".
  • the adapter assembly 29' as well as the adapter member 29 previously described are preferably initially slidably mounted around the exterior of the needle 4.
  • the smallest interior passage thereof cannot be very much smaller than the needle diameter so the adapter member is not stretched too tightly over the needle lumen. Accordingly, when the catheter 3 is pulled into sealing position within the base of the adapter member 29, it
  • the modified catheter delivery device although having a much longer catheter 3" is of the same overall length as the previously described catheter delivery device 1, the additional space for the longer catheter being obtained by providing many more additional coils in the portion of the catheter within the bulb-like portion 6b. Also, the enlarged rear end of the catheter 3" is located completely within the bulb-like portion 6b.
  • the adapter assembly 29 includes a main body member 58 which ultimately forms a liquid-passing connector attachable to the said infusion bottle system connector 23 or other connectors.
  • the main body member which is preferably made of a relatively rigid molded synthetic plastic material has a main central tubular portion 58a having a straight passageway extending from the inlet to the outlet end thereof. This passageway has a relatively small front passageway portion 60a at the front end of the main body member 58 which loosely receives the needle.
  • the front passageway portion 60a joins a relatively large passageway portion 62, the front end of which is defined by an abutment shoulder 64 formed by a transversely extending wall 66.
  • An annular groove 68 is formed in the larger passageway portion 62.
  • the seat-forming sleeve 70 has a passageway 70 extending therethrough, the defining walls of which in the contracted condition of the sleeve form a slide friction fit with the catheter 3" and a very tight fit with the first enlargement 3d at the end of the catheter 3".
  • the seat-forming sleeve 70 may be held in place against the aforementioned shoulder 64 by a cylindrical holding member 72 which fits within the rear end of the large passageway portion 62 of the main body member 58.
  • the holding member '72 is releasably interlocked within the main body member 58 and projects from the rear end thereof where it can be grasped after removal of the adapter assembly 29 from the needle to separate it from the main body member 58.
  • the holding member 72 may include an annular rib 72a on the outside thereof which releasably snaps into the aforementioned annular groove 68 in the large passageway portion 62 of the main body member 58.
  • the holding member 72 which is also preferably made of a relatively rigid synthetic plastic material, has an open ended passageway 72b which loosely fits on the needle 4.
  • the adapter assembly 29 is frictionally held on the base of the needle by the seat-forming sleeve 70 which frictionally engages the needle 4.
  • the friction between the confronting surfaces of the sleeve 70 and the needle 4 is such that a modest longitudinal force applied to the entire adapter assembly 29' can pull the assembly off of the needle 4.
  • a needle cover 25' with a catheter holding member (not shown) is removably secured around the front end of the main body member 58.
  • the most advantageous means for effecting movement of the adapter assembly 29 off of the needle 4 is a flexible elongated pull tab 75, which may be made of any suitable material which can withstand the tensile strength required to pull the adapter assembly 29' from the needle 4 and also to overcome the small force which opposes the pulling of the catheter 3" from the needle lumen.
  • the pull tab 75 has an opening 77 at the inner end thereof which loosely fits around the holding member 72. This inner end portion of the pull tab is held in place against the rear end of the holding member 72 by radial projections 80 of the main body part 58.
  • the pull tab 75 has a relatively large front end portion 75a having an opening 79 therein.
  • the pull tab 75 has a length so it can extend substantially beyond the front end of the needle 4.
  • the degree to which the pull tab 75 extends beyond the needle is important for reasons to be explained.
  • the main body member 58 of the adapter assembly 29' is provided with diametrically opposed radial projections 80-80 which are adapted to interlock with one form of liquid-passing connector (not shown) different from the infusion bottle system connector 23 to which connector the main body member 58 may be secured subsequent to its separation from the rest of the catheter delivery device.
  • liquid-passing connector not shown
  • the holding member 72 is ultimately disconnected from the main body member 58 to permit the insertion within the rear end of the larger passageway portion 62 of liquid-passing connector like connector 23 of the infusion bottle system 26.
  • the removal of the adapter assembly 29' and the catheter 3" from the needie 4 is effected by first placing the enlarged front end portion 75a of the pull tab 75 against the portion of the ejected catheter immediately beyond the front end of the needle 4, as indicated by the dashed line position thereof shown in FIG. 17.
  • the catheter 3" is gripped tightly through the opening 79 of the enlarged front end portion of the pull tab which then has substantial slack therein so the pull tab and the catheter can be pulled a distance together from the end of the needle without effecting any movement of the adapter assembly.
  • the rear end of the catheter will snap into a position within the interior of the adapter assembly where it cannot touch any contaminating surfaces.
  • the broadest aspect of the invention envisions a catheter snapping into a position outside of but yet adjacent to the end of the adapter assembly.
  • the degree of slack provided in the pull tab when it is placed against the catheter just beyond the front end of the needle is, therefore, selected to provide just this result.
  • the sleeve 70 contracts snugly around the catheter 3 thereby to fix the relative position between the adapter assembly 29 and the rear end of the catheter 3".
  • the catheter is grasped and pulled as far as it can be pulled within the adapter assembly which brings the first enlargement 3d of the catheter within the passageway 70 of the seat-forming sleeve 70.
  • the distance which the rear end of the catheter has to move upon leaving the needle lumen to snap into the end of the adapter is minimized in the illustrated embodiment of the invention by the fact that the adapter assembly is positioned adjacent the needle hub 8 at a point preferably spaced only a small distance forwardly of the point where the enlarged rear end portion of the catheter becomes wedged in the needle lumen after catheter ejection.
  • the pulling of the enlargement 3d within the sleeve 70 expands the sleeve tightly against the defining walls of the large passageway section 62 of the main body member 58 to form such a firm and tight seal and connection between the catheter and the sleeve at this point that it is impossible to pull the catheter through this sleeve.
  • the holding member 72 is then pulled from the body member 58 and discarded with the pull tab.
  • the tubular portion 58a of the main body member 58 of the adapter assembly has a completely flat surface 82 on one side thereof in a plane extending longitudinally thereof.
  • the main body member has a pair of outwardly projecting wings 8484 which on one side thereof are coplanar with and form an extension of the flat surface 82.
  • the wings 8484 give the main body member 58 lateral stability when placed against the skin 85 of the users body adjacent the point where the catheter 3 enters the same as shown in FIG. 19.
  • the main body member 58 when viewed in transverse cross ection as shown in FIG. 19, has a generally triangular or tapered configuration providing thin, marginal, longitudinal sides so a string of adhesive tape 86 can securely retain the main body member 58 by engaging the skin immediately beyond the thin longitudinal sides 82a82a of the flat surface 82.
  • a medical device for injecting an elongated member into a passageway of the body of an animal or human, the device including a housing having a feeding nose portion with means for emplacing the feeding nose portion in said passageway and from which feeding nose portion said elongated member is to be ejected into said passageway after the feeding nose portion has been inserted therein, said feeding nose portion having an open-ended lumen communicating with a fluidholding space within said housing, said housing to contain fluid to be pressurized and including means for effecting the pressurizing of said fluid so as to cause a flow of fluid through said lumen and around an elongated member therein with sufficient velocity to impel the elongated member therethrough, the improvement comprising: an elongated member contained within said housing space, said elongated member having limp and elastic consistency and extending into or in close proximity to said lumen of said feeding nose portion, said elongated member having an outside diameter at least about the size of the minimum diameter of the lumen of said feeding nose portion so as not to be freely passable
  • portion of the elongated member to be ejected from the lumen is at least about the size of substantially all portions of the lumen of said feeding nose portion.
  • said pressure effecting means is a manually movable means which is a part of said medical device, said elongated member being so compressible that a modest application of force applied to said movable means is sufficient to create the pressure in said housing which compresses the elongated member to a size less than said minimum diameter of the feeding nose portion lumen.
  • said pressure effecting means is a manually movable means incorporated in said medical device, said elongated member being so compressible that a modest application of force applied to said movable means is sufficient to create said pressure in said housing which compresses the elongated member to a size less than said minimum diameter of the feeding nose portion lumen.
  • said elongated member is a catheter having a passageway extending therethrough.
  • said feeding nose portion is a cannulated needle
  • said means for preventing the ejection of the rear end of said catheter including an enlargement on the end thereof which is not compressible by said fluid pressurization to the degree to pass through said lumen of said needle under the fluid pressure and which becomes frictionally locked in the needle lumen when it reaches the same, the fluid pressure in the catheter then expanding the catheter outwardly to lock the same in the lumen, and said catheter closure means temporarily initially obstructs said rear open end of said catheter so that the ejection of said catheter through said feeding nose portion lumen separates the rear end of the catheter from said catheter closure means.
  • said catheter closure means includes a portion projecting loosely within the rear end of the catheter.
  • said device is provided with a compressible tubular extension having a passageway for making connection between an external source of liquid to constitute said fluid in said device and the interior of said housing, there being a plug-forming member snugly fitted within said passageway to close the same off from the exterior of the device, said tubular extension when pinched between the users fingers elongates in a given direction to separate the same from said plug-forming member at the points of elongation thereof to form clearance spaces for the passage of said liquid into said housing, and said portion projecting into said rear end of the catheter being a forwardly projecting extension on said plugforming member.
  • a medical device for feeding a catheter into a blood vessel or other passageway comprising a housing defining a catheter holding space and including a feeding nose portion through which the catheter is to be guided into said passageway, a catheter in said space, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which blocks the complete passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such that by manually pulling on the portion of the catheter projecting from the feeding nose portion the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose portion, and a liquid-passing adapter means adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said adapter means having an open-ended passageway the defining walls of which are initially in spaced surrounding relation to said catheter but slidably frictionally fits around said feeding nose portion, said adapter means and catheter, on the one hand, and
  • said pull tab means is a flexible elongated member extendable to a point substantially beyond the end of said feeding nose portion, the initial inlet end of said adapter means is positioned forwardly of said enlargement on said catheter when the enlargement is in said locked portion in said housing, said flexible elongated pull tab member being adapted initially to be positioned against a portion of the ejected catheter at the end of the feeding nose portion where there is slack in the pull tab member and when pulled outwardly with the catheter from this point until the pull tab is taut the catheter is distended and pulled without movement of said adapter means, the slack in said pull tab member when initially positioned at the end of said feeding nose portion is such that when the catheter and adapter means are finally separated from the feeding nose portion by continuation of the pulling of said pull tab member and catheter, the catheter is at least in the vicinity of said adapter means where it quickly contracts into a position adjacent to or inside of said adapter means passageway to avoiding striking contaminated surface.
  • said adapter means is initially mounted around said feeding nose portion and includes a main body portion made of a relatively rigid material which body portion includes a passageway which loosely surrounds the feeding nose portion, a resilient expandable sleeve anchored in the latter passageway and expanded into frictional engagement around said feeding nose portion, and the enlarged portion of said catheter being pullable into sealing relation with said sleeve when said catheter and adapter means are pulled from said feeding nose portion, the sleeve being expanded by said enlarged portion of the catheter against the defining walls of said adapter means passageway.
  • said adapter means has a main body portion with a relatively fiat side adapted to lay against the skin where the main body portion can be immobilized thereagainst by a strip of adhesive tape applied thereover.
  • a device for feeding a catheter through a feeding nose into a blood vessel or other passageway including a body from which the feeding nose extends, the body and feeding nose defining a space, a catheter in said space to be fed through the feeding nose into the passageway involved, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which prevents the passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such a size that, by manually pulling on the portion of the catheter projecting from the feeding nose, the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose, the improvement comprising a liquid-passing adapter means adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said liquidpassing adapter means including a main body portion made of a relatively rigid material and including a passageway the defining walls of which loosely surround said feeding nose,

Abstract

In a device for ejecting a catheter into a passageway like a blood vessel, the device including a housing containing a catheter extending or extendable into a feeding nose, such as a cannulated needle, the housing interior to be fluid pressurized to effect fluid flow around the catheter. The catheter is inwardly compressible and of a size where the outer diameter is about equal to and preferably somewhat greater than the inner diameter of the needle lumen. The build-up of fluid pressure within the housing of the device was found to compress the catheter making it of a smaller diameter than the needle lumen and in the process forming, at least during the initial stages of catheter movement, a catheter with a piston-like profile so that the catheter is impelled by fluid friction and piston action.

Description

United States Patent [191 Smith [111 3,826,256 51 July 30, 1974 1 1 CATHETER DELIVERY DEVICE [75] Inventor: Gordon E. Smith, Sun Prairie, Wis.
[73] Assignee: Medidyne Corporation, Chicago, 111.
[22] Filed: Jan. 13, 1972 [21] Appl. No.: 217,468
[52] US. Cl 128/2144, 128/348, 221/64, 221/278, 226/97 [51] Int. Cl A6lm 5/18 [58] Field of Search 128/2144, 221, 218 R,
[56] References Cited UNITED STATES PATENTS 2,518,165 8/1950 Millard 128/2l4.4 2,999,499 9/1961 Willet 128/214.4 3,010,453 11/1961 Dohcrtyml 128/214.4 3,185,152 5/1965 Ring 128/221 X 3,262,449 7/1966 Pannier, Jr. et a1. 128/2144 3,463,152 8/1969 Sorcnson 128/2144 3.509.880 5/1970 Guttman 128/221 3,561,445 2/1971 Katerndahl et a1. 128/2144 3.572.334 3/1971 Pctterson 128/214.4 3,633,579 1/1972 Alley 3.703.174 11/1972 Smith 128/348 X FOREIGN PATENTS OR APPL1CAT1ONS Germany 128/2144 Primary ExaminerRichard A. Gaudet Assistant Examiner-J. C. McGowan Attorney, Agent, or Firm-Wallensteen, Spangenberg, Hattis & Strampel [57] ABSTRACT In a device for ejecting a catheter into a passageway like a blood vessel, the device including a housing containing a catheter extending or extendable into a feeding nose, such as a cannulated needle, the housing interior to be fluid pressurized to effect fluid flow around the catheter. The catheter is inwardly compressible and of a size where the outer diameter is about equal to and preferably somewhat greater than the inner diameter of the needle lumen. The build-up of fluid pressure within the housing of the device was found to compress the catheter making it of a smaller diameter than the needle lumen and in the process forming, at least during the initial stages of catheter movement, 'a catheter with a piston-like profile so that the catheter is impelled by fluid friction and piston acmen.
27 Claims, 24 Drawing Figures PAIENIEB mums snmsor 7.
CATHETER DELIVERY DEVICE This invention relates to a catheter delivery device which incorporates the invention of and is an improvement over the catheter delivery devices disclosed in my application Ser. No. 54,732 entitled METHOD AND APPARATUS FOR CATHETER INJECTION filed July 14, 1970. The catheter injection devices disclosed in this application and the catheter device which is the subject of the present invention utilize the build-up of fluid pressure in a catheter housing having a feeding nose for guiding the catheter, to cause the flow of fluid between the catheter and the inside wall of the feeding nose (which may be a cannulated needle) to inject the catheter within a body passageway such as a blood vessel. Where the catheter is to be injected into a blood vessel, the catheter material is most advantageously very limp to minimize irritation of the blood vessel walls and to enable the catheter readily to follow irregular paths within the blood vessel.
It is desirable to make the outside diameter of the catheter as close as possible to the outer diameter of the needle through which it passes, so that upon removal of the needle after catheter injection, the skin, blood vessel wall and other tissue punctured by the needle will contract as tightly as possible around the catheter to minimize leakage of fluid around the catheter. ldeally, therefore, although limitations on the operation of catheter delivery devices heretofore was thought to mitigate against the same, it would be desirable for the catheter diameter to be equal to and even greater than the diameter of the defining walls of the needle lumen'through which it is guided into a blood vessel or other passageway. However, despite the obvious desirability for catheters of a diameter as close to the needle diameter as possible, prior to the present invention, catheters placed in body passageways, like blood vessels, using the lumen of a cannulated needle or other feeding nose as an exterior guiding means, were always of a size smaller than the lumen of the guiding means, so that the catheter can freely slide or pass through the lumen. For example, if astiff catheter of the same size as the lumen of the guiding means is utilized, the friction between the catheter and the lumen would be such that the catheter could not be advanced through the lumen of the guiding means. Even in the case of limp flexible catheters like that used in the catheter delivery devices disclosed in said copending application, where the catheter is ejected from the lumen of the guiding means by the flow of fluid around the catheter, it was thought necessary to utilize a catheter diameter smaller than the diameter of the lumen of the guiding means by a number of thousandths of inches to provide clearance for the ready flow of fluid around the catheter so the fluid would not flow through the catheter and expand the same against the lumen of the guiding means, and to keep the manual compression forces necessary to build up a fluid eject a long catheter an appreciable length from the catheter delivery device involved. in such case, the impelling force on the catheter is the friction between the fast moving stream of liquid moving around the catheter and the outside walls of the catheter. It was found that in mass producing the catheter delivery devices of certain catheter sizes, a certain percentage of the catheters would not eject from the devices.
In the present invention, for a given needle size, a larger catheter can be ejected from the needle than was thought heretofore possible and greater catheter ejection velocities are obtained for a modest increase in fluid pressure making catheter injection more effective, especially in circumstances when the catheter must be ejected substantial distances through irregular paths within blood vessels and the like. Moreover, the present invention has substantially reduced the reject ratios to a point where practically all manufactured catheter delivery devices are operable in ejecting their catheters with appreciable velocities.
The present invention is based on my discovery that where an elastic catheter which is compressible is utilized, most preferably one made of a soft, very pliable rubber-like material having the limp resilient and inert quality of a silicone elastomer and the outer diameter of the catheter is made at least about equal to at least the minimum diameter of the needle lumen (i.e. some needle lumens have a variation in diameter) and preferably at least equal to or, even better, slightly larger than the diameter of the entire length of a needle lumen, where it would be assumed that the fit between the catheter and defining walls of the needle lumen would prevent any catheter ejection, the catheter is actually ejected at a higher velocity'and more readily for a modest increase in manual force applied to a squeeze bulb or the like than in the case where a small but finite clearance was provided as described above.
In examining into the possible reasons, it was concluded that the fluid pressure within the catheter delivery device housing was instrumental in compressing the catheter so that the catheter within the needle lumen is very closely spaced from the walls of the needle lumen during the application of the fluid pressure. Also, for a given pressure, a greater velocity of fluid flow results in the very small clearance between the catheter and needle lumen walls which increases the fluid shear forces acting on the catheter. The pressure acting on the catheter is believed to provide, during at least the initial catheter ejection operation, a forwardly and outwardly flaring profile which provides a rearwardly facing shoulder against which the force of fluid ejected from the needle lumen is applied to substantially increase the ejection force on the catheter. Thus, there is both a piston-like action and an increased frictional force acting on the catheter aiding the cather ejection process. It should be noted that where the catheter is the same size or larger than substantially the entire length of the needle lumen while the increase of fluid pressure within the housing of the catheter delivery device provides an external inward compressive force on the radially outwardly facing surfaces of the catheter located rearwardly of the needle lumen, one would think that the radially outwardly facing surfaces of the portion of the catheter inside the needle lumen with which the catheter makes engagement are not so exposed and thus remain uncompressed where it cannot be moved from the needle. However, the junction between the initially compressed and uncompressed portions of the catheter is not an abrupted right angled juncture, but is a gradually forwardly and outwardly flaring portion which has both radially outwardly and rearwardly facing components, so that there is a surface against which the pressure can act to compress the same radially inwardly. The aforementioned forwardly and outwardly flaring profile of the catheter, which initially is located at the point where the catheter first enters the needle lumen of the same or smaller size, under the application of fluid pressure is caused to progressively move down the length of the catheter toward the front of the needle. Finally, the entire catheter leaves contact with the needle lumen at the end of the needle lumen where the fluid pressure on the catheter is greatly reduced permitting the catheter to expand at this point to its initial size. The catheter then has a piston-like profile at the end of the needle lumen and also, it is believed, an outwardly flaring profile within the needle lumen and so presents rearwardly facing surfaces against which the moving fluid applies a force to aid in catheter ejection. Thus, at the instant when the catheter looses contact with the needle lumen walls, the catheter is free to be impelled by both the increased frictional forces of the flow of fluid which then begins around the catheter and also by the force of the fluid flow against the rearwardly facing component of the catheter profile.
In the case where a needle hub is swaged upon the end of a cannulated needle body, there is generally produced an inwardly extending shoulder at the point where the swaging operation is carried out which is of lesser size than the rest of the needle lumen. A pistonlike action described above can be achieved by a catheter having a diameter which is equal to or somewhat larger than the diameter of the swaged portion of the needle lumen but of a smaller diameter than the rest of the lumen. In this case, upon application of fluid pres sure, a piston-like profile is formed just beyond the shoulder and since the catheter initially engages the lumen over only a very small length of the needle lumen, the catheter instantaneously leaves contact with the needle lumen and a piston-like action immediately takes place to aid in moving the catheter both by the friction of the moving fluid around the catheter and by the force of fluid pressure against the rearwardly facing portion of the catheter profile.
It should be noted that even if it were appreciated that the application of fluid pressure within the housing of the catheter delivery device provides an external inward compressive force on the radially outwardly facing surfaces of the catheter initially engaging the needle lumen walls, one would think also that there would be an equal radially outwardly directed pressure on the inside of the catheter which would cancel out such compressive force. However, as soon as fluid starts to flow within the catheter, there is a pressure drop along the catheter interior which, because the rear end of the catheter is usually a substantial distance from the point where the catheter makes contact with the needle lumen walls, results in a substantial pressure drop thereat. The substantial fluid pressures which are readily built up within a catheter delivery device by the squeezing of a bulb or the like was found easily to overcome any opposition to compression of the catheter even when the catheter is larger in size than the entire length of the needle lumen because of the pressure drop within the catheter.
There is, however, a problem with regard to flushing air out of a catheter delivery device of the invention where liquid is used to impel the catheter into a blood vessel. In the most preferred form of the present invention, the catheter delivery device is manufactured in a state where it has to be subsequently filled with a sterile liquid like saline solution or other liquid. When air is expelled by the charging of the catheter delivery device having a catheter of a smaller size than the needle lumen, by pointing the needle end thereof upwardly and feeding liquid into the bottom portion of the device, as the liquid rises within the device it readily fills both the space around the catheter and the catheter interior and drives the air ahead of the same. However, when the catheter is made of a size where it engages the walls of the needle lumen, the small head pressures which are normally present (for example where an infusion liquid from a hanging infusion bottle is caused to enter the catheter delivery device the head pressure is usually only about 2-3 feet of liquid) are insufficient to overcome the opposition to compression of the catheter for normal catheter lengths (e.g. 9 inches) and some air remains trapped within the device which is expelled when the catheter is impelled by the liquid moving around the catheter.
Another aspect of the present invention, therefore, is in overcoming this in one of two ways. In one form of the invention, the catheter utilized is made of an unusually long length which length depends upon the inside diameter of the catheter so that the pressure drop occurring when the liquid rises in the catheter is so substantial at the point where the catheter contacts the needle lumen walls that even a few feet of head pressure is sufficient to compress the catheter to permit liquid and air to pass air around the catheter. In another form of the invention, where the catheter is of a more common length, such as 9 inches, a similar result is achieved by forming a partial obstruction at the rear of the catheter which effects a substantial pressure drop or hinderance to liquid flow at this point, so that in effeet a similar pressure drop is present at the points where the catheter makes contact with the needle lumen walls.
In accordance with another feature of the present invention, the catheter injection device is provided with its own valve so that at any desirable time the device can be charged with a sterile liquid and disconnected from the source of liquid and be ready immediately to be used where the catheter injection operation is desired.
Another feature of the invention relates to an improved infusion liquid-receiving adapter assembly carried on the feeding nose of a catheter delivery device and which can easily be pulled from the feeding nose together with the rear end portion of an ejected catheter temporarily held in the feeding nose lumen, and then sealingly related to the released end of the catheter.
The above and other features and advantages of the invention will become apparent uponn making reference to the specification to follow, the claims and the drawings wherein:
FIG. 1 illustrates an initially liquid-free catheter delivery device in its packaged condition;
FIG. 2 is a longitudinal, sectional view through the catheter delivery device shown in FIG. 1, after it is removed from the package;
FIG. 3 is an enlarged, longitudinal, sectional view through the rear end portion of the catheter delivery device of FIG. 2, taken along section line 3-3 therein;
FIG. 4 is an enlarged, transverse, sectional view through the rear end portion of the catheter delivery device of FIG. 2, taken along section line 4-4 therein;
FIG. 5 is an enlarged, transverse, sectional view through the front end portion of the catheter delivery device shown in FIG. 2, taken along section line 5-5 thereof;
FIG. 6 is a view showing the catheter delivery device of FIGS. 1-5 connected to an infusion bottle assembly for filling the delivery device with liquid and oriented to expunge air therefrom;
FIG. 7 is a transverse sectional view of that portion of the rear end of the catheter delivery device shown in FIG. 4 when the portion shown in squeezed to open the check valve formed thereby;
FIG. 8 is an enlarged, fragmentary, longitudinal, sectional view through the front end portion of the catheter delivery device of FIGS. l-4 during the time air is being expunged therefrom;
FIG. 9A is a greatly enlarged, fragmentary, longitudinal sectional view of the front and rear end portions of the catheter containing portions of the catheter delivery device of FIGS. l-8 after having been filled with liquid and prior to the application of fluid pressure within the same and when the catheter has a diameter equal to the diameter'of the main portion of the needle lumen;
FIG. 9B is a longitudinal, sectional view corresponding to FIG. 9A during the instant when fluid pressure has been applied to the fluid within the catheter delivery device of FIG. 9A but prior to the bodily movement of the catheter from the catheter delivery device;
FIG. 9C is a longitudinal, sectional view corresponding to FIGS. 9A and 98 at the moment the catheter within the device has a configuration where the flow of fluid is impelling the same from the needle thereof;
FIG. 91) is a longitudinal sectional view of the base portion of the needle and the enlarged rear end portion of the catheter frictionally locked within the base of the needle after completion of a catheter ejection operation;
FIG. 10A is a greatly enlarged, fragmentary, longitudinal, sectional view of the front and rear end portions of the catheter containing portions of the catheter delivery device of FIGS. l-8 after having been filled with liquid and prior to the application of fluid pressure within the same, and when the catheter has a diameter just equal to the diameter of the narrow swaged point of the needle lumen;
FIG. 10B is a longitudinal, sectional view corresponding to FIG. 10A during the instant when fluid pressure has been applied to the fluid within the catheter delivery device of FIG. 9A but prior to the bodily movement of the catheter from the needle thereof;
FIG. 10C is a longitudinal, sectional view corresponding to FIGS. 10A and 108 at the moment the catheter within the device has a configuration where the flow of fluid is impelling the same from the catheter delivery device;
FIG. 11 is a greatly enlarged view of the front end portion of the catheter containing portions of the catheter delivery device of FIGS. 1-8 after having been filled with liquid and prior to the application of fluid pressure within the same, and when the catheter has a diameter greater than that of the main portion of the needle lumen;
FIG. 12 is an enlarged, longitudinal, sectional view of the depressible bulb-like portion of the catheter delivery devices of FIGS. l-ll after the bulb-like portion has been fully compressed to eject the catheter from the catheter delivery device;
FIG. 13 is a view showing the separation of the assembly of the end of the catheter, infusion liquidreceiving adapter and associated sleeve from the needle and the attached tubing;
FIG. 14 is a longitudinal, sectional view of the catheter and the infusion-receiving adapter after the catheter has been fully pulled into interlocking relationship with the adapter and the adapter attached to the complimentary connector of an infusion bottle assembly shown in FIG. 6;
FIG. 15 is a partially sectional view though a moditied form of catheter delivery device which includes a unique infusion liquid-receiving adapter construction;
FIG. 16 is a fragmentary longitudinal sectional view through the adapter holding portion of the catheter delivery device of FIG. 15 taken along section lines 16-16 therein;
FIG. 17 is a fragmentary, longitudinal, sectional view showing the front portion of the catheter delivery device in FIG. 15 with the catheter injected into a blood vessel and the needle withdrawn from the blood vessel and in the process of being pulled over the catheter and through the infusion liquid-receiving adapter;
FIG. 18 is a partly broken away viewv of the remaining portion of the infusion liquid-receiving adapter and catheter of FIG. 17 after separation from the needle, portions of the adapter have been discarded, the catheter has been pulled securely into interlocking relationship with the remaining portion of the adapter, and the adapter taped to the patients body; and
FIG. 19 is a transverse sectional view through the taped remaining portion of the adapter of FIG. 18, taken along section line 19-19 thereof.
As shown in FIG. 1, an embodiment of the catheter delivery device of the invention identified by reference number 1 is shown initially packaged in a sterilized state in a suitable transparent package or container 2 in which the device may be sterilized in a conventional way. The catheter delivery device 1 as illustrated is designed for injecting a catheter 3 through a cannulated needle 4 or the like into a blood vessel. However, the
device can be modified for other uses and with or without the use of a cannulated needle as a tissue piercing catheter guiding means. The catheter delivery device 1 includes a catheter containing body assembly 6 comprising a main tubular body portion 6a which may be made of a suitable transparent synthetic plastic tubing. The rear end of the tubing terminates in a laterally extending bulb-like portion 6b, also made of a synthetic plastic material, which is the fluid pressure applying means of the catheter injection device 1. (However, other fluid pressure applying means could be used in the present invention other than bulb-like portion.) The cannulated needle 4 is connected to the front end of the tubing 6a by a hollow needle hub 8 which is somewhat larger than the tubing 60 and over which hub the tubing is securely anchored. The needle 4 is anchored within the hub 8. The lumen 4a of the needle 4 forms a continuation of an open-ended passageway 14 within the tubing 6a. The catheter 3 has an intermediate portion 30 extending through the passageway 14 and a front end portion 3b extending part way into the needle 4. Where the length of catheter desired is longer than the distance between the bulb-like portion 6b of the catheter containing body assembly 6 and a point near the forward end of the needle, the intermediate portion 3a of the catheter 3 terminates at the rear thereof in a coiled portion 3c confined in a neatly coiled relation by the walls of the bulb-like portion 6b.
The bulb-like portion 6b is most advantageously a member having a dome-shaped depressible wall 15 (FIG. '12). The tubing 6a has a rear end portion which extends within a tubular extension of the cylindrical wall 17 where the tubing communicates with a chamber 22 within the bulb-like portion 6b. A short compressible tubular section 24 extends rearwardly from the bulb-like portion 6b and has a passageway 18 communicating with the chamber 22 and forming at the end thereof a portion 180 for snugly receiving a connector 23 at the end of an infusion bottle assembly 26 (FIG. 6) or other source ofa sterile liquid like saline solution. (For blood vessel applications, gases like carbon diox ide could be used instead of a liquid, but liquids are greatly preferred as the catheter injection fluid for this application). The tubular section 24 has friction fitted in the front end portion of the passageway 18 a plug or pinch valve-forming member 21 which closes the passageway 18. The member 21 has a forwardly extending pin-like projection 21a (FIG. 3) over which the rear end portion 3d of the catheter most desirably loosely extends to form a plug or hinderance to fluid flow through the catheter. The pinching of the tubular section 24 elongates the cross-section thereof as shown in F IG. 7 to form openings on opposite sides of the check valve-forming member for passage of fluid into the catheter delivery device.
When the dome-shaped wall 15 is depressed, it preferably snaps into an inverted shape as shown in FIG. 12, so that once the bulb is fully compressed, the depressed wall 15 remains collapsed. However, if the wall 15 is only slightly depressed and released, it returns to its initial position. Such slight depression of the wall 15 is sometimes carried out after the needle has been apparently placed in a blood vessel as an aid in drawing some blood into the catheter delivery device which, if visible through the transparent portions of the device, indicates that the needle tip is located in a blood vessel.
The end of the needle 4 carries a preferably transparent synthetic plastic needle cover 25 best shown in FIG. 8 having an opening 250 at the front end thereof. The needle cover has fixed therein a long catheter holding member 27 which extends into the front end portion of the needle lumen 4a to prevent movement of the catheter from the needle when air is flushed from the device. The catheter holding member 27, as illustrated, has a flat shank portion 27a frictionally held in the needle cover and terminates in a head portion 2712 outside of the needle cover. The needle cover 25 has a front cylindrical portion 25b defining a corresponding cylindrically shaped passageway 25c therein, the defining walls of which snugly engage the needle 4. The needle cover 25 has a rearwardly outwardly flaring portion 25d which engages around the front end portion of an infusion liquid-receiving adapter member 29 which is used to make connection to the connector 23 of an infusion bottle assembly 26 shown in FIG. 6 after ejection of the catheter from the catheter delivery device 1. The flat profile of the shank portion 27a of the catheter holding member forms clearance spaces through which air and liquid can pass through the needle lumen 4a in front of the catheter and the opening 250 at the front end of the needle cover after flowing between the catheter and the needle lumen in a manner to be described. The needle cover 25 and the catheter holding member 27 carried thereby are removed together as a unit from the needle after air has been expunged from the catheter delivery device. (Manifestly, the needle cover 25 and the catheter holding member can have other configurations.)
The base portion of the needle 4 is initially tightly enveloped by the defining walls of a passageway 46 in the nose portion 30 of the infusion liquid-receiving adapter member 29 made of an expandable resilient plastic material which has a hollow cylindrical rear portion 31 which fits within the front end of a sleeve 34 preferably made of a transparent synthetic plastic material. The rear end of the sleeve 34 has a flanged end portion 35 with an opening 36 into a cylindrical space 39 within the sleeve 34. The tubing 60 fits with a slide or loose fit into the rear sleeve opening 36. The needle hub 8 secured to the front of the tubing 6a makes a slide frictional fit within the sleeve 34 and can be removed with the needle 4 from the sleeve by pulling the same rearwardly to separate it from the sleeve, as shown in F 1G.
The catheter 3 is made of a material which is completely inert to body fluids and tissue so it can remain indefinitely in the body passage involved and does not irritate such tissue. The catheter should also be very limp and elastic and most desirably when it is to be coiled it should have a resiliency as well as the limpness of gum rubber or a well cooked wet noodle. An example of what is meant by a limp and elastic catheter is one which has an elongation of 450 to 800 percent as determined by a STM test procedure P 412. Unlike gum rubber which is not inert to body fluids, a catheter material which has all these qualities is silicone elastomer. Limp materials like silicone elastomer remain in a fairly tightly coiled condition idefinitely without any significant curvature setting therein, so that the catheter will at all times uncoil in a substantially straight condition (i.e. without any significant curvature). If the catheter has any substantial curvature set therein, it would catch on the walls of the needle or housing, making it impossible to feed the catheter from the needle. The resiliency of the catheter material enables the catheter to feed easily from a coiledto a straight configuration and keeps the coils neatly pressed against the walls of the bulb-like portion 6b.
The catheter 3 preferably has a two-step enlargement at the very rear end thereof, the first enlargement being identified by reference numeral 3d and the second enlargement being identified by reference numeral 3d" (FIG. 9A). The pin-like projection 21a of the check valve-forming member 21 fits into the interior of the first enlargement 3d preferably loosely but sufficiently close to the catheter walls to reduce the opening therein to a size where liquid cannot readily enter the same, causing a substantial pressure drop when fluid tries to flow therethrough. For example, a clearance of about 0.002 inch was found to be satisfactory in one case. As shown in FIG. 9A, the outer diameter of the first enlargement 3d is somewhat greater than the inner diameter of the needle lumen 4a and joins the portion of the catheter in front of the same by a forwardly tapered portion 41 so that when catheter ejection is initiated and the first enlargement reaches the needle lumen 4a, the tapered part will become wedged in the needle lumen 4a and reduce the catheter clearance to zero. The wedging of the tapered portion 41 of the first enlargement 3d of the need] lumen 4a prevents any backward movement of the catheter which could bring the catheter against the sharp end of the needle to sever the catheter. Also, the enlargements 3d and 3d of the catheter are of such a length and thickness that by pulling on the catheter 3 the enlargements will distend in length and contract in diameter so the catheter can be readily pulled through the needle 4.
Although the needle hub can have a variety of constructions, as shown, for example, in FIG. 9A, it has a flanged portion 8a from which extends a reduced forwardly projecting nose portion 8b defining a passageway 8b' into which the cylindrical cannulated needle 4 extends and is anchored as by swaging the nose portion therearound. This forms a short inwardly projecting portion or constriction at 40' within the needle lumen which defines an opening or constriction in the needle lumen of less diameter than the rest of the needle lumen. The needle hub further has a rearwardly projecting skirt portion 8c defining an inner cylindrical bore 80 of greater size than said nose portion passageway 8a and merging therewith through a tapered opening 8d. The catheter enlargements 3d and 3d readily fit within the hub bore 8c. The hub bore 80' communicates with the rear of the hub 8 through a flared entryway 8c". The outer surface of the skirt is serrated at 45 to form a friction surface over which the tubing 6a snugly fits.
As best shown in FIG. 14, when the adapter member 29 is separated from the needle 4 after catheter ejection the connector 23 of the infusion bottle assembly 26 shown in FIG. 6 fits into an initially cylindrical opening 40 formed by the rear cylindrical portion 31 thereof. The adapter member 29 is also provided with a recess 42 behind the nose portion 30 for receiving the second enlargement 3d of the catheter 3 after completion of catheter ejection and the removal of the adapter member and the catheter from the rest of the catheter delivery device in a manner to be explained. The nose portion passageway 46 of the adapter member after removal from the needle contracts to a size smaller in size than the first enlargement 3d at the end of the catheter and into which such enlargement 3d is pulled and seals after catheter ejection.
As previously indicated, the catheter delivery device 1 impels the catheter 3 by causing a relatively high velocity flow of fluid between the catheter and the defining walls of the needle lumen. This requires that at least during the time that the catheter is being ejected from the catheter delivery device the catheter 1 must be of a size and shape to pass freely through the needle lumen 4a. As previously indicated, in accordance with the invention, catheter ejection is most effectively achieved by making the compressible catheter of an initial diameter such that it would not freely pass through the needle lumen unless the size thereof would reduced from its initial size, which is achieved by the compression of the catheter when fluid pressure is applied thereto. The catheter is thus made of a diameter so that it makes initial engagement with the walls of the needle lumen 4a as, for example, shown in FIG. 9A.
The first step in using the catheter deliverly device 1 is to connect the catheter delivery device to a source of a sterile liquid like the infusion bottle assembly 26 shown in FIG. 6, by removing the device from the package 2 and connecting the rearwardly projecting tubular section 24 of the device to the connector 23 at the end of the infusion bottle assembly 26. The catheter delivery device is then picked up and held so that the tip of the needle points upwardly, and a pinch clamp 46 of the infusion bottle assembly is released to permit infu sion liquid to pass to the connector 23. The compressible tubular section 24 of the catheter delivery device is then squeezed to permit the infusion fluid to flow into the device until liquid flows through the opening 25a at the end of the needle cover 25 indicating that the air above the same has been expunged from the device. The tubular section 24 is then released and disconnected from the infusion connector 23. During the filling operation, the liquid readily rises within the catheter delivery device and first fills the bulb-like portion 6b and pushes any air upwardly ahead of the same. The fluid also enters the rear or bottom end of the catheter because it is only loosely obstructed by the pin-like projection 21a, to flush air from the catheter. When the air and the liquid reaches the bottom portion of the needle lumen 4a, although the catheter engages the walls of the needle lumen, the compressible nature of the catheter and the lower pressure within the catheter resulting from the drop in fluid pressure as the liquid flows through the obstructed rear end of the catheter and the length of the catheter behind the point where the catheter enters the needle lumen enables the pressure caused by the pressure head of the infusion bottle system slightly to compress the catheter so the air and liquid can pass around the catheter and gain access to the clearance spaces between the shank portion 27a of the catheter holding member 27 and the upper or front end of the needle lumen and between the shank portion 27a of the catheter holding member 27 and the needle cover 25, ultimately passing through the opening 25a in the end of the needle cover.
When the catheter delivery device is ready to be used for catheter injection, the needle cover 25 and the catheter holding member 27 carried thereby are removed by pulling the same from the end of the needle 4. The needle 4 is then inserted into the blood vessel involved and after a tourniquet has been applied in the usual manner for needle insertion, the depresssible wall 15 of the bulb-like portion 6b is fully depressed to inject the catheter 3 into the blood vessel involved.
In FIGS. 9A through 93, the catheter 3 is shown as having a diameter equal to the diameter of the needle lumen 4a (and therefore somewhat greater than the diameter of the constricted portion of the needle lumen at 4a). For example, the constriction at 4a may be 0.003 inch less than the diameter of the rest of the needle lumen. FIG. 9A illustrates the condition of the catheter delivery device 1 before application of pressure thereto. When the catheter 3 is lubricated with alcohol or the like, it has been found that when its diameter is equal to the diameter of the needle lumen the catheter can be manually slid by the lumen constriction at 4a" into the position shown in FIG. A. When the bulb-like portion 6b of the catheter delivery device is depressed, this sudden application of appreciable pressure initially causes a compression of the portion of the catheter positioned rearwardly of the needle lumen 4b as shown in FIG. 98. While this pressure is not instantaneously applied to the radially outwardly facing surfaces of the portion of the catheter within the needle lumen, which surfaces contact the needle lumen walls, the juncture between the compressed portion of the catheter within the tubing 6 a and the portion of the catheter within the needle lumen not yet compressed is a gradually outwardly flaring portion 50. This outwardly flaring portion exposes a small exterior portion of the catheter at the base of the needle lumen to which the fluid pressure is applied and this portion of the catheter is fully compressed to form another outwardly flaring portion immediately in front of the same. It can thus be seen that, upon initial application of fluid pressure, the portion of the catheter within the needle lumen becomes progres sively compressed until the entire length thereof leaves contact with the needle lumen walls. Then the flow of fluid is instrumental in effecting movement of the catheter from the needle lumen, and when the catheter reaches the outer end of the needle lumen, as shown in FIG. 9C, the catheter sharply expands to the diameter of the needle lumen. The pressure conditions against the catheter vary somewhat along the length of the needle lumen from a point where it leaves the needle lumen where the pressure is a minimum and equal to the patients blood pressure to a point deeply within the lumen where a maximum pressure is realized. There will, therefore, be a slightly progressive outward flaring of the catheter for its full length within the needle lumen even after it completely leaves contact with the needle lumen, and this outwardly flaring portion of the catheter as well as the more sharply outwardly expanding portion of the catheter as it leaves the needle lumen provides rearwardly facing surfaces against which liquid pressure is applied to form a piston-like action which cooperates with the force applied to the catheter by the friction of fluid flow therearound, to impart a greater impelling force to the catheter.
Some liquid also flows into and along the inside of the catheter as a result of the depression of the bulb-like portion 6a, but the friction to such flow in the long and initially obstructed catheter causes a substantial pres sure drop in the catheter aiding in the catheter compression described. The resulting high velocity flow of liquid around the catheter causes such a sudden movement of the catheter that the catheter movement occurs faster than the flow of liquid in the catheter and little or no liquid actually flows out of the catheter during catheter ejection. When the enlarged rear end of the catheter reaches the base of the needle lumen 4a, the tapered part 41 of the first enlargement 3d of the catheter wedges in the needle lumen walls. The rather large momentum of the catheter does not pull the rear end of the catheter through the needle lumen because when the enlargement reaches and enters the needle lumen, there is suddenly only liquid flow in the catheter (which has left the pin-like extension 21a) which causes a resultant outward expansion of the catheter within the needle lumen, firmly to lock the catheter in place within the needle lumen.
The present invention also includes the use of a catheter whose outer diameter is approximately equal to or slightly greater than the diameter of the constricted portion of the needle lumen at 4a and somewhat smaller than the remaining diameter of the needle lumen. This application of the invention is illustrated in FIGS. 10A, 10B and 10C which respectively show the condition of the catheter before application of fluid pressure, at the instant of initial application of fluid pressure and when the fluid pressure and resultant fluid flow has caused the catheter to leave the needle lumen. As shown in FIG. 10B, the initial compression of the catheter instantaneously causes the catheter to lose contact with the constriction of the needle lumen and thereby provides a piston-like profile which is instantaneously instrumental in effecting movement of the catheter from the lumen as it provides a shoulder against which the fluid pressure propels the catheter forwardly along with the friction of the moving fluid against the sides of the catheter.
The present invention is also effective when the catheter is of a greater size than the diameter of the needle lumen for its full length, such as an oversize of 0.005 inch. In this embodiment of the invention shown in FIG. 11, it is not readily possible to mount the catheter within the needle lumen prior to the application of pressure to the catheter. Accordingly, the front end of a preferably modified catheter 3 having preferably a beveled tip 53 in the needle hub bore 80' where there is preferably only the tapered surface 8d in front of the oversized catheter against which the catheter can strike. Upon application of fluid pressure by depression of the bulb-like portion 6b, the catheter is guided into the needle lumen adjacent to which it is located and is compressed by the pressure conditions involved for the same reasons and in the same manner as shown in FIGS. 9A-9C.
After catheter injection, the needle is withdrawn from the patient, the user grasps the flanged portion 35 of the sleeve 34 with one hand (usually the left hand) and pulls on the tubing 6a with the other hand to bring the needle hub 8 against a small shoulder 55 (FIG. 12) at the rear of the sleeve 34 where the tip of the needle is retracted within the infusion liquid-receiving adapter member 29. The assembly of the adapter member 29, the sleeve and the catheter are held together as a unit by pinching the portion of the sleeve 34 around the adapter 29 with one hand which compresses the desirably compressible adapter around the catheter to hold the same in place while the tubing is pulled sharply with the other hand. This stretches and elongates the catheter enlargement 3d and 3d'fland the rest of the catheter to reduce the size thereof where it slips from the needle lumen. The sleeve 34 now acts like a catheter holding skirt by preventing the catheter from dropping upon contaminating surfaces. The catheter is then pulled fully into the adapter member 29 where it is drawn into its extreme position therein, as shown in FIG. 14. The sleeve 34 is pulled from the adapter member 29 and thrown away. The rear cylindrical portion 31 of the adapter member 29 may then be connected to the connector 23 of the infusion bottle assembly 26.
Refer now to FIGS. 15-19 which illustrates a modification of the present invention involving, among other things, the elimination of the sleeve 34 which is primarily for the purpose of protecting the catheter when the catheter is pulled into position within the adapter member 29, and the inclusion of a modified infusion liquidreceiving adapter assembly 29. Also, the catheter 3" utilized is much longer than the catheters 3 previously described in that it is not necessary to use an obstruction like the plug-forming extension 21a in the open rear end of the catheter to reduce the pressure at the point where the catheter engages the needle lumen walls to an extent permitting the escape of air and fluid around the catheter under relatively small pressure head conditions. (The catheter 3" is, of course, fully impelled into the blood vessel involved and after catheter ejection would be withdrawn from the blood vessel an amount to leave the desired length of catheter in the blood vessel.)
One of the reasons for the modified adapter assembly 29 in addition to simplifying the construction of the device by eliminating the sleeve 34, is that it permits a tighter fit between it and the enlarged rear end of the catheter 3". It should be noted that the adapter assembly 29' as well as the adapter member 29 previously described are preferably initially slidably mounted around the exterior of the needle 4. In order to permit the expandable adapter member 29 in the previously described embodiments of the invention to be pulled along the needle without too much difficulty, the smallest interior passage thereof cannot be very much smaller than the needle diameter so the adapter member is not stretched too tightly over the needle lumen. Accordingly, when the catheter 3 is pulled into sealing position within the base of the adapter member 29, it
-is sometimes possible to so distend the enlarged end of the catheter (whose maximum size is limited) to a point where it can be pulled completely through the not very much smaller passageway of the adapter member in which it is to be locked and sealed. This is not possible with the adapter assembly 29' now to be described.
As best shown in FIG. 15, the modified catheter delivery device, although having a much longer catheter 3", is of the same overall length as the previously described catheter delivery device 1, the additional space for the longer catheter being obtained by providing many more additional coils in the portion of the catheter within the bulb-like portion 6b. Also, the enlarged rear end of the catheter 3" is located completely within the bulb-like portion 6b.
As best shown in FIG. 16, the adapter assembly 29 includes a main body member 58 which ultimately forms a liquid-passing connector attachable to the said infusion bottle system connector 23 or other connectors. The main body member which is preferably made of a relatively rigid molded synthetic plastic material has a main central tubular portion 58a having a straight passageway extending from the inlet to the outlet end thereof. This passageway has a relatively small front passageway portion 60a at the front end of the main body member 58 which loosely receives the needle.
The front passageway portion 60a joins a relatively large passageway portion 62, the front end of which is defined by an abutment shoulder 64 formed by a transversely extending wall 66. An annular groove 68 is formed in the larger passageway portion 62.
There is located at the forward end of the larger passageway portion 62 of the main body member 58 a resilient rubber-like seat-forming sleeve 70 which is expanded to fit over the needle 4. The seat-forming sleeve has a passageway 70 extending therethrough, the defining walls of which in the contracted condition of the sleeve form a slide friction fit with the catheter 3" and a very tight fit with the first enlargement 3d at the end of the catheter 3". The seat-forming sleeve 70 may be held in place against the aforementioned shoulder 64 by a cylindrical holding member 72 which fits within the rear end of the large passageway portion 62 of the main body member 58. The holding member '72 is releasably interlocked within the main body member 58 and projects from the rear end thereof where it can be grasped after removal of the adapter assembly 29 from the needle to separate it from the main body member 58. To this end, the holding member 72 may include an annular rib 72a on the outside thereof which releasably snaps into the aforementioned annular groove 68 in the large passageway portion 62 of the main body member 58. The holding member 72, which is also preferably made of a relatively rigid synthetic plastic material, has an open ended passageway 72b which loosely fits on the needle 4.
The adapter assembly 29 is frictionally held on the base of the needle by the seat-forming sleeve 70 which frictionally engages the needle 4. However, the friction between the confronting surfaces of the sleeve 70 and the needle 4 is such that a modest longitudinal force applied to the entire adapter assembly 29' can pull the assembly off of the needle 4. A needle cover 25' with a catheter holding member (not shown) is removably secured around the front end of the main body member 58.
The most advantageous means for effecting movement of the adapter assembly 29 off of the needle 4 is a flexible elongated pull tab 75, which may be made of any suitable material which can withstand the tensile strength required to pull the adapter assembly 29' from the needle 4 and also to overcome the small force which opposes the pulling of the catheter 3" from the needle lumen. The pull tab 75 has an opening 77 at the inner end thereof which loosely fits around the holding member 72. This inner end portion of the pull tab is held in place against the rear end of the holding member 72 by radial projections 80 of the main body part 58. The pull tab 75 has a relatively large front end portion 75a having an opening 79 therein.
The pull tab 75 has a length so it can extend substantially beyond the front end of the needle 4. The degree to which the pull tab 75 extends beyond the needle is important for reasons to be explained.
The main body member 58 of the adapter assembly 29' is provided with diametrically opposed radial projections 80-80 which are adapted to interlock with one form of liquid-passing connector (not shown) different from the infusion bottle system connector 23 to which connector the main body member 58 may be secured subsequent to its separation from the rest of the catheter delivery device. As will appear, only the main body member 58 is ultimately used to make connection to an external source of liquid like an infusion bottle assembly. The holding member 72 is ultimately disconnected from the main body member 58 to permit the insertion within the rear end of the larger passageway portion 62 of liquid-passing connector like connector 23 of the infusion bottle system 26.
After catheter ejection is effected, the removal of the adapter assembly 29' and the catheter 3" from the needie 4 is effected by first placing the enlarged front end portion 75a of the pull tab 75 against the portion of the ejected catheter immediately beyond the front end of the needle 4, as indicated by the dashed line position thereof shown in FIG. 17. The catheter 3" is gripped tightly through the opening 79 of the enlarged front end portion of the pull tab which then has substantial slack therein so the pull tab and the catheter can be pulled a distance together from the end of the needle without effecting any movement of the adapter assembly. In the example of the invention illustrated in the drawings (see especially FIG. 17), when the pull tab while gripping the catheter therethrough has been pulled to its fullest extent so any further movement of the pull tab will effect sliding movement of the adapter assembly on the needle, the catheter has been distended to a point where the second enlargement 3d" thereof begins sliding along the needle lumen. 1n the illustrated embodiment of the invention where the rear end of the catheter 3" is initially spaced behind the adapter assembly 29' (although contiguous thereto), the distention of the catheter without movement of the adapter assembly in effect brings the final position of the rear end of the catheter closer to the inlet end of the adapter assembly 29'. Thus, when the catheter leaves the needle lumen and the tension in the catheter is relieved, the rear end of the catheter will snap into a position within the interior of the adapter assembly where it cannot touch any contaminating surfaces. (However, the broadest aspect of the invention envisions a catheter snapping into a position outside of but yet adjacent to the end of the adapter assembly.) The degree of slack provided in the pull tab when it is placed against the catheter just beyond the front end of the needle is, therefore, selected to provide just this result.
When the portion of the main body member 58 of the adapter assembly containing the seat-forming sleeve 70 leaves the needle, the sleeve 70 contracts snugly around the catheter 3 thereby to fix the relative position between the adapter assembly 29 and the rear end of the catheter 3". After both the catheter 3" and the adapter assembly 29' have been pulled from the end of the needle, the catheter is grasped and pulled as far as it can be pulled within the adapter assembly which brings the first enlargement 3d of the catheter within the passageway 70 of the seat-forming sleeve 70. The distance which the rear end of the catheter has to move upon leaving the needle lumen to snap into the end of the adapter is minimized in the illustrated embodiment of the invention by the fact that the adapter assembly is positioned adjacent the needle hub 8 at a point preferably spaced only a small distance forwardly of the point where the enlarged rear end portion of the catheter becomes wedged in the needle lumen after catheter ejection. The pulling of the enlargement 3d within the sleeve 70 expands the sleeve tightly against the defining walls of the large passageway section 62 of the main body member 58 to form such a firm and tight seal and connection between the catheter and the sleeve at this point that it is impossible to pull the catheter through this sleeve. The holding member 72 is then pulled from the body member 58 and discarded with the pull tab.
The tubular portion 58a of the main body member 58 of the adapter assembly. has a completely flat surface 82 on one side thereof in a plane extending longitudinally thereof. The main body member has a pair of outwardly projecting wings 8484 which on one side thereof are coplanar with and form an extension of the flat surface 82. The wings 8484 give the main body member 58 lateral stability when placed against the skin 85 of the users body adjacent the point where the catheter 3 enters the same as shown in FIG. 19. The main body member 58 when viewed in transverse cross ection as shown in FIG. 19, has a generally triangular or tapered configuration providing thin, marginal, longitudinal sides so a string of adhesive tape 86 can securely retain the main body member 58 by engaging the skin immediately beyond the thin longitudinal sides 82a82a of the flat surface 82.
It is apparent that the embodiments of the present invention described above provides an exceedingly effective, easy to use, and relatively inexpensive means for injecting catheters into blood vessels and separating the catheters from the same and securing the catheters to a liquid-passing connector. The same principles of the invention utilized in the injection of catheters by liquid into blood vessels can be applied in readily injecting compressible catheters or other slim elongated members into other passageways of the body with liquid or air. While elongated members made of silicone elastomer (which is incompressible in solid form) must be hollow or have other spaces formed therein like catheters to be compressible, the invention could be used to inject other elongated members in solid form which are readily compressible in such form.
It should be understood that numerous modifications may be made in the most preferred forms of the invention described without deviating from the broader aspects of the invention.
1 claim:
1. In a medical device for injecting an elongated member into a passageway of the body of an animal or human, the device including a housing having a feeding nose portion with means for emplacing the feeding nose portion in said passageway and from which feeding nose portion said elongated member is to be ejected into said passageway after the feeding nose portion has been inserted therein, said feeding nose portion having an open-ended lumen communicating with a fluidholding space within said housing, said housing to contain fluid to be pressurized and including means for effecting the pressurizing of said fluid so as to cause a flow of fluid through said lumen and around an elongated member therein with sufficient velocity to impel the elongated member therethrough, the improvement comprising: an elongated member contained within said housing space, said elongated member having limp and elastic consistency and extending into or in close proximity to said lumen of said feeding nose portion, said elongated member having an outside diameter at least about the size of the minimum diameter of the lumen of said feeding nose portion so as not to be freely passable through the lumen when the elongated member is in its initial state, said elongated member being sufficiently compressible that under said fluid pressurization the elongated member compresses to a size less than said minimum diameter of said lumen where fluid is forced by said pressure around the elongated member in said lumen to eject the same therefrom, and means for preventing the ejection of the rear end portion of the elongated member from said feeding nose portion lumen.
2. The medical device of claim 1 wherein the portion of the elongated member to be ejected from the lumen is at least about the size of substantially all portions of the lumen of said feeding nose portion.
3. The medical device of claim 1 wherein the lumen of said feeding nose portion has a construction therein and the portion of the elongated member to be ejected from the lumen is at least about the size of said construction but smaller than the size of the rest of the lumen.
4. The medical device of claim 1 wherein the portion of the elongated member to be ejected from the lumen is initially slightly larger than substantially all portions of the lumen of said feeding nose portion.
5. The medical device of claim 1 wherein said pressure effecting means is a manually movable means which is a part of said medical device, said elongated member being so compressible that a modest application of force applied to said movable means is sufficient to create the pressure in said housing which compresses the elongated member to a size less than said minimum diameter of the feeding nose portion lumen.
6. The medical injection device of claim 2 wherein said pressure effecting means is a manually movable means incorporated in said medical device, said elongated member being so compressible that a modest application of force applied to said movable means is sufficient to create said pressure in said housing which compresses the elongated member to a size less than said minimum diameter of the feeding nose portion lumen.
7. The medical device of claim 1 wherein said elongated member is a catheter having a passageway extending therethrough.
8. The medical device of claim 7 wherein said fluid is a sterile liquid but said housing is initially free of such liquid, there is provided connector means for filling said housing with said sterile liquid from a source of such liquid which may have only a few feet of head pressure, the rear end of said catheter is permanently completely open, and said catheter having such a length such that the resistance to liquid flow through said passageway thereof reduces the pressure therein at the points where the catheter engages the walls of said feeding nose portion lumen, so that filling said housing with said liquid at said head pressure provides sufficient pressure around the catheter at said points that the catheter will compress so said liquid and air ahead of the same pass around the catheter.
9. The medical device of claim 7 wherein said fluid is a sterile liquid but said housing is initially free of such liquid, there is provided connector means for filling said housing with said sterile liquid from a source of such liquid which may have only a few feet of head pressure, said catheter is of insufficient length that liquid flow through the same under said head pressure will cause a sufficient pressure drop at the points where the catheter engages the walls of said feeding nose portion lumen to enable said head pressure to compress the catheter to permit flow of air and fluid flow around the catheter, and there is provided catheter closure means for obstructing the open rear end of said catheter to produce said pressure drop at said points where the catheter engages the walls of the feeding nose portion lumen.
10. The medical injection device of claim 9 wherein said feeding nose portion is a cannulated needle, said means for preventing the ejection of the rear end of said catheter including an enlargement on the end thereof which is not compressible by said fluid pressurization to the degree to pass through said lumen of said needle under the fluid pressure and which becomes frictionally locked in the needle lumen when it reaches the same, the fluid pressure in the catheter then expanding the catheter outwardly to lock the same in the lumen, and said catheter closure means temporarily initially obstructs said rear open end of said catheter so that the ejection of said catheter through said feeding nose portion lumen separates the rear end of the catheter from said catheter closure means.
11. The medical device of claim 10 wherein said catheter closure means includes a portion projecting loosely within the rear end of the catheter.
12. The medical device of claim 11 wherein said device is provided with a compressible tubular extension having a passageway for making connection between an external source of liquid to constitute said fluid in said device and the interior of said housing, there being a plug-forming member snugly fitted within said passageway to close the same off from the exterior of the device, said tubular extension when pinched between the users fingers elongates in a given direction to separate the same from said plug-forming member at the points of elongation thereof to form clearance spaces for the passage of said liquid into said housing, and said portion projecting into said rear end of the catheter being a forwardly projecting extension on said plugforming member.
13. The medical device of claim 4 wherein the front end of the elongated member is initially positioned immediately contiguous to the inlet end of the lumen of said feeding nose portion.
14. The medical device of claim 13 wherein the front end of said elongated member is tapered readily to be guided into said feeding nose portion lumen.
15. In a medical device for feeding a catheter into a blood vessel or other passageway, the device comprising a housing defining a catheter holding space and including a feeding nose portion through which the catheter is to be guided into said passageway, a catheter in said space, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which blocks the complete passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such that by manually pulling on the portion of the catheter projecting from the feeding nose portion the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose portion, and a liquid-passing adapter means adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said adapter means having an open-ended passageway the defining walls of which are initially in spaced surrounding relation to said catheter but slidably frictionally fits around said feeding nose portion, said adapter means and catheter, on the one hand, and at least said feeding nose portion of said housing on the other hand, being manually separable after the catheter has been injected into said passageway by pulling the same relatively apart, said adapter means passageway having at least one portion within which the enlarged rear end portion of the catheter sealingly fits, the improvement comprising: pull tab means attached to said adapter means and extendable to a point beyond the end of said feeding nose portion where the pull tab means and an ejected portion of the catheter can be held together with one hand while a part of said housing is grasped with the other hand, so that by pulling one hand away from the other the adapter means and catheter can be separated from the feeding nose portion.
16. The medical device of claim wherein said pull tab means is a flexible elongated member extendable to a point substantially beyond the end of said feeding nose portion, the initial inlet end of said adapter means is positioned forwardly of said enlargement on said catheter when the enlargement is in said locked portion in said housing, said flexible elongated pull tab member being adapted initially to be positioned against a portion of the ejected catheter at the end of the feeding nose portion where there is slack in the pull tab member and when pulled outwardly with the catheter from this point until the pull tab is taut the catheter is distended and pulled without movement of said adapter means, the slack in said pull tab member when initially positioned at the end of said feeding nose portion is such that when the catheter and adapter means are finally separated from the feeding nose portion by continuation of the pulling of said pull tab member and catheter, the catheter is at least in the vicinity of said adapter means where it quickly contracts into a position adjacent to or inside of said adapter means passageway to avoiding striking contaminated surface.
17. The medical device of claim 16 when said slack in said pull tab member is equal to the distance the catheter must be distended to finally release the rear end of the catheter for movement in said housing.
18. The medical device of claim 15 wherein the initial normal position of said adapter means and the enlarged portion of said catheter in said blocked position is such that upon pulling said pull tab member and catheter to the point where both are separated from said feeding nose portion, the rear end of the catheter is located inside of said adapter means passageway.
19. The medical device of claim 15 wherein said enlarged portion on the end of said catheter is of a size to become frictionally locked within said feeding nose portion upon catheter ejection, and said adapter means is slidably and frictionally mounted around said feeding nose portion.
20. The medical device of claim 15 wherein said adapter means is initially mounted around said feeding nose portion and includes a main body portion made of a relatively rigid material which body portion includes a passageway which loosely surrounds the feeding nose portion, a resilient expandable sleeve anchored in the latter passageway and expanded into frictional engagement around said feeding nose portion, and the enlarged portion of said catheter being pullable into sealing relation with said sleeve when said catheter and adapter means are pulled from said feeding nose portion, the sleeve being expanded by said enlarged portion of the catheter against the defining walls of said adapter means passageway.
21. The medical device of claim 15 wherein said pull tab means has an opening at the inner end thereof which receives and surrounds said feeding nose portion at a point rearwardly of said adapter means, said housing having a portion projecting outwardly thereof behind said inner end of said pull tab means, said pull tab means being confined between the rear end of said adapter means and said enlarged portion of said housing, a forward pull on said pull tab means bringing the inner end of the pull tab means against the rear end of said adapter means to move the same forwardly along said feeding nose portion.
22. The medical device of claim 20 wherein said expandable sleeve in said adapter means passageway is anchored to said passageway by a holding member removably anchored within the rear end of said adapter means passageway which holding member includes an open ended passageway the defining walls of which initially loosely fit around said feeding nose portion and upon removal of the adapter means from the feeding nose portion receives and surrounds a portion of the catheter ejected from the device, said holding member being removable from said main body portion of the adapter means to free the rear end portion of said adapter means passageway to receive said complimentary liquid-passing connector.
23. The medical device of claim 15 wherein said adapter means has a main body portion with a relatively fiat side adapted to lay against the skin where the main body portion can be immobilized thereagainst by a strip of adhesive tape applied thereover.
24. The medical device of claim 23 wherein said main body portion has outwardly extending portions providing substantial surface areas both longitudinally and transversely of the main body portion to stabilize the same when resting against a skin surface.
25. The medical device of claim 23 wherein said main body portion has outer surfaces meeting the longitudinal side margins of said fiat surface at an acute angle thereby forming relatively thin longitudinal edges so adhesive tape enveloping the same makes contact with the skin adjacent the point where it makes contact with the main body portion of the adapter means.
26. In a device for feeding a catheter through a feeding nose into a blood vessel or other passageway, the device including a body from which the feeding nose extends, the body and feeding nose defining a space, a catheter in said space to be fed through the feeding nose into the passageway involved, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which prevents the passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such a size that, by manually pulling on the portion of the catheter projecting from the feeding nose, the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose, the improvement comprising a liquid-passing adapter means adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said liquidpassing adapter means including a main body portion made of a relatively rigid material and including a passageway the defining walls of which loosely surround said feeding nose, a resilient expandable seat-forming sleeve anchored in said passageway and frictionally engaging around said feeding nose, said adapter means and catheter, on the one hand, and at least said feeding nose, on the other hand, being manually separable after the catheter has been injected into said passageway, and said enlarged portion of said catheter being pullasaid passageway, said holding member being made of a relatively rigid material and having an open ended passageway which is initially loosely received around the feeding nose and which when the adapter means is removed from the feeding nose, is removable from the rear end of said passageway of said main body portion of the adapter means to provide clearance for the insertion of said complimentary liquid-passing connector.

Claims (27)

1. In a medical device for injecting an elongated member into a passageway of the body of an animal or human, the device including a housing having a feeding nose portion with means for emplacing the feeding nose portion in said passageway and from which feeding nose portion said elongated member is to be ejected into said passageway after the feeding nose portion has been inserted therein, said feeding nose portion having an open-ended lumen communicating with a fluid-holding space within said housing, said housing to contain fluid to be pressurized and including means for effecting the pressurizing of said fluid so as to cause a flow of fluid through said lumen and around an elongated member therein with sufficient velocity to impel the elongated member therethrough, the improvement comprising: an elongated member contained within said housing space, said elongated member having limp and elastic consistency and extending into or in close proximity to said lumen of said feeding nose portion, said elongated member having an outside diameter at least about the size of the minimum diameter of the lumen of said feeding nose portion so as not to be freely passable through the lumen when the elongated member is in its initial state, said elongated member being sufficiently compressible that under said fluid pressurization the elongated member compresses to a size less than said minimum diameter of said lumen where fluid is forced by said pressure around the elongated member in said lumen to eject the same therefrom, and means for preventing the ejection of the rear end portion of the elongated member from said feeding nose portion lumen.
2. The medical device of claim 1 wherein the portion of the elongated member to be ejected from the lumen is at least about the size of substantially all portions of the lumen of said feeding nose portion.
3. The medical device of claim 1 wherein the lumen of said feeding nose portion has a construction therein and the portion of the elongated member to be ejected from the lumen is at least about the size of said construction but smaller than the size of the rest of the lumen.
4. The medical device of claim 1 wherein the portion of the elongated member to be ejected from the lumen is initially slightly larger than substantially all portions of the lumen of said feeding nose portion.
5. The medical device of claim 1 wherein said pressure effecting means is a manually movable means which is a part of said medical device, said elongated member being so compressible that a modest application of force applied to said movable means is sufficient to create the pressure in said housing which compresses the elongated member to a size less than said minimum diameter of the feeding nose portion lumen.
6. The medical injection device of claim 2 wherein said pressure effecting means is a manually movable means incorporated in said medical device, said elongated member being so compressible that a modest application of force applied to said movable means is sufficient to create said pressure In said housing which compresses the elongated member to a size less than said minimum diameter of the feeding nose portion lumen.
7. The medical device of claim 1 wherein said elongated member is a catheter having a passageway extending therethrough.
8. The medical device of claim 7 wherein said fluid is a sterile liquid but said housing is initially free of such liquid, there is provided connector means for filling said housing with said sterile liquid from a source of such liquid which may have only a few feet of head pressure, the rear end of said catheter is permanently completely open, and said catheter having such a length such that the resistance to liquid flow through said passageway thereof reduces the pressure therein at the points where the catheter engages the walls of said feeding nose portion lumen, so that filling said housing with said liquid at said head pressure provides sufficient pressure around the catheter at said points that the catheter will compress so said liquid and air ahead of the same pass around the catheter.
9. The medical device of claim 7 wherein said fluid is a sterile liquid but said housing is initially free of such liquid, there is provided connector means for filling said housing with said sterile liquid from a source of such liquid which may have only a few feet of head pressure, said catheter is of insufficient length that liquid flow through the same under said head pressure will cause a sufficient pressure drop at the points where the catheter engages the walls of said feeding nose portion lumen to enable said head pressure to compress the catheter to permit flow of air and fluid flow around the catheter, and there is provided catheter closure means for obstructing the open rear end of said catheter to produce said pressure drop at said points where the catheter engages the walls of the feeding nose portion lumen.
10. The medical injection device of claim 9 wherein said feeding nose portion is a cannulated needle, said means for preventing the ejection of the rear end of said catheter including an enlargement on the end thereof which is not compressible by said fluid pressurization to the degree to pass through said lumen of said needle under the fluid pressure and which becomes frictionally locked in the needle lumen when it reaches the same, the fluid pressure in the catheter then expanding the catheter outwardly to lock the same in the lumen, and said catheter closure means temporarily initially obstructs said rear open end of said catheter so that the ejection of said catheter through said feeding nose portion lumen separates the rear end of the catheter from said catheter closure means.
11. The medical device of claim 10 wherein said catheter closure means includes a portion projecting loosely within the rear end of the catheter.
12. The medical device of claim 11 wherein said device is provided with a compressible tubular extension having a passageway for making connection between an external source of liquid to constitute said fluid in said device and the interior of said housing, there being a plug-forming member snugly fitted within said passageway to close the same off from the exterior of the device, said tubular extension when pinched between the user''s fingers elongates in a given direction to separate the same from said plug-forming member at the points of elongation thereof to form clearance spaces for the passage of said liquid into said housing, and said portion projecting into said rear end of the catheter being a forwardly projecting extension on said plug-forming member.
13. The medical device of claim 4 wherein the front end of the elongated member is initially positioned immediately contiguous to the inlet end of the lumen of said feeding nose portion.
14. The medical device of claim 13 wherein the front end of said elongated member is tapered readily to be guided into said feeding nose portion lumen.
15. In a medical device for feeding a catheter into a blood vessel Or other passageway, the device comprising a housing defining a catheter holding space and including a feeding nose portion through which the catheter is to be guided into said passageway, a catheter in said space, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which blocks the complete passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such that by manually pulling on the portion of the catheter projecting from the feeding nose portion the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose portion, and a liquid-passing adapter means adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said adapter means having an open-ended passageway the defining walls of which are initially in spaced surrounding relation to said catheter but slidably frictionally fits around said feeding nose portion, said adapter means and catheter, on the one hand, and at least said feeding nose portion of said housing on the other hand, being manually separable after the catheter has been injected into said passageway by pulling the same relatively apart, said adapter means passageway having at least one portion within which the enlarged rear end portion of the catheter sealingly fits, the improvement comprising: pull tab means attached to said adapter means and extendable to a point beyond the end of said feeding nose portion where the pull tab means and an ejected portion of the catheter can be held together with one hand while a part of said housing is grasped with the other hand, so that by pulling one hand away from the other the adapter means and catheter can be separated from the feeding nose portion.
16. The medical device of claim 15 wherein said pull tab means is a flexible elongated member extendable to a point substantially beyond the end of said feeding nose portion, the initial inlet end of said adapter means is positioned forwardly of said enlargement on said catheter when the enlargement is in said locked portion in said housing, said flexible elongated pull tab member being adapted initially to be positioned against a portion of the ejected catheter at the end of the feeding nose portion where there is slack in the pull tab member and when pulled outwardly with the catheter from this point until the pull tab is taut the catheter is distended and pulled without movement of said adapter means, the slack in said pull tab member when initially positioned at the end of said feeding nose portion is such that when the catheter and adapter means are finally separated from the feeding nose portion by continuation of the pulling of said pull tab member and catheter, the catheter is at least in the vicinity of said adapter means where it quickly contracts into a position adjacent to or inside of said adapter means passageway to avoiding striking contaminated surface.
17. The medical device of claim 16 when said slack in said pull tab member is equal to the distance the catheter must be distended to finally release the rear end of the catheter for movement in said housing.
18. The medical device of claim 15 wherein the initial normal position of said adapter means and the enlarged portion of said catheter in said blocked position is such that upon pulling said pull tab member and catheter to the point where both are separated from said feeding nose portion, the rear end of the catheter is located inside of said adapter means passageway.
19. The medical device of claim 15 wherein said enlarged portion on the end of said catheter is of a size to become frictionally locked within said feeding nose portion upon catheter ejection, and said adapter means is slidably and frictionally mounted around said feeding nose portion.
20. The medical device of claim 15 wherein said Adapter means is initially mounted around said feeding nose portion and includes a main body portion made of a relatively rigid material which body portion includes a passageway which loosely surrounds the feeding nose portion, a resilient expandable sleeve anchored in the latter passageway and expanded into frictional engagement around said feeding nose portion, and the enlarged portion of said catheter being pullable into sealing relation with said sleeve when said catheter and adapter means are pulled from said feeding nose portion, the sleeve being expanded by said enlarged portion of the catheter against the defining walls of said adapter means passageway.
21. The medical device of claim 15 wherein said pull tab means has an opening at the inner end thereof which receives and surrounds said feeding nose portion at a point rearwardly of said adapter means, said housing having a portion projecting outwardly thereof behind said inner end of said pull tab means, said pull tab means being confined between the rear end of said adapter means and said enlarged portion of said housing, a forward pull on said pull tab means bringing the inner end of the pull tab means against the rear end of said adapter means to move the same forwardly along said feeding nose portion.
22. The medical device of claim 20 wherein said expandable sleeve in said adapter means passageway is anchored to said passageway by a holding member removably anchored within the rear end of said adapter means passageway which holding member includes an open ended passageway the defining walls of which initially loosely fit around said feeding nose portion and upon removal of the adapter means from the feeding nose portion receives and surrounds a portion of the catheter ejected from the device, said holding member being removable from said main body portion of the adapter means to free the rear end portion of said adapter means passageway to receive said complimentary liquid-passing connector.
23. The medical device of claim 15 wherein said adapter means has a main body portion with a relatively flat side adapted to lay against the skin where the main body portion can be immobilized thereagainst by a strip of adhesive tape applied thereover.
24. The medical device of claim 23 wherein said main body portion has outwardly extending portions providing substantial surface areas both longitudinally and transversely of the main body portion to stabilize the same when resting against a skin surface.
25. The medical device of claim 23 wherein said main body portion has outer surfaces meeting the longitudinal side margins of said flat surface at an acute angle thereby forming relatively thin longitudinal edges so adhesive tape enveloping the same makes contact with the skin adjacent the point where it makes contact with the main body portion of the adapter means.
26. In a device for feeding a catheter through a feeding nose into a blood vessel or other passageway, the device including a body from which the feeding nose extends, the body and feeding nose defining a space, a catheter in said space to be fed through the feeding nose into the passageway involved, the catheter being made of a resilient readily manually stretchable material and having an enlarged portion at the rear end portion thereof which prevents the passage thereof from said space so the rear end portion of the catheter cannot be ejected from the device, said enlarged portion at the rear end of the catheter being such a size that, by manually pulling on the portion of the catheter projecting from the feeding nose, the enlarged portion will distend to a point where the catheter slips from said space through said feeding nose, the improvement comprising a liquid-passing adapter means adapted to fit a complimentary liquid-passing connector communicating with a liquid-holding container, said liquid-passing adapter means including a main body portion made of a relatively rigid material and including a passageway the defining walls of which looSely surround said feeding nose, a resilient expandable seat-forming sleeve anchored in said passageway and frictionally engaging around said feeding nose, said adapter means and catheter, on the one hand, and at least said feeding nose, on the other hand, being manually separable after the catheter has been injected into said passageway, and said enlarged portion of said catheter being pullable into sealing relation with the interior of said sleeve when said catheter and adapter means are pulled from said feeding nose, the sleeve being sized to be expanded by the presence therein of the enlarged portion of said catheter against the defining walls of said adapter means passageway.
27. The device of claim 26 wherein said seat-forming sleeve is anchored within said passageway of said main body portion of the adapter means by a holding member removably anchored within the rear end portion of said passageway, said holding member being made of a relatively rigid material and having an open ended passageway which is initially loosely received around the feeding nose and which when the adapter means is removed from the feeding nose, is removable from the rear end of said passageway of said main body portion of the adapter means to provide clearance for the insertion of said complimentary liquid-passing connector.
US00217468A 1972-01-13 1972-01-13 Catheter delivery device Expired - Lifetime US3826256A (en)

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