Transcutaneous infusion apparatus and methods of manufacture and use

• US 5,248,301 A
• Filed: 11/27/1989
• Issued: 09/28/1993
• Est. Priority Date: 12/03/1987
• Status: Expired due to Fees

• Current Assignee: Medex Incorporated (Smiths Group International Holdings Ltd.)
• Original Assignee: Medfusion, Inc. (NextGen Healthcare, Inc.)
• Inventors: Moschler, Melvin B. Jr., Koenig, Marvin E. Jr.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/441,299
• Time in Patent Office: 1,401 Days
• Field of Search: 604/93, 604/117, 604/164, 604/165, 604/166-167, 604/169, 604/170, 604/175, 604/272, 604/110, 604/263
• US Class Current: 604/288.02
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 2205/197 by the seal material
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

Apparatus for accessing the circulatory system of a person or animal includes a port and a device for accessing the port. The access device has a solid introducer with a catheter received thereabout. The introducer and catheter are covered by telescoping containers which expose the insertion ends of the introducer and catheter only at the time of insertion. The catheter is separable from the access device after insertion.

Claims

1. A transcutaneous infusion apparatus, comprising:

an implantable infusate injection port including a housing forming a reservoir with a self-sealing septum on an access side and a solid surface on a side opposite, said port having an outlet tube, said port being adapted for implantation in a human or animal body with the septum located under the skin and the outlet tube leading to an infusion site in the body;

a needle having a tip and a longitudinal shaft;

catheter means for accessing the reservoir of said port, said catheter means fitting about a portion of said shaft of said needle while allowing said tip to be exposed; and

means for holding said needle and said catheter means in order to insert said needle and said catheter means through said septum, said holding means including means for pushing said needle and said catheter means during insertion until said needle contacts said solid surface of said port, said pushing means including means for yielding with respect to said needle to allow said catheter means to more closely approach said solid surface, said yielding means comprising a yieldable material which is generally rigid at force levels sufficient to introduce said needle and said catheter means through said septum but which will yield and collapse when greater force is applied thereto, said needle and said holding means being separable from said inserted catheter means.

2. Apparatus in accordance with claim 1 wherein said catheter means includes a catheter having proximal and distal ends and a wall intermediate said catheter proximal and distal ends with a surface transverse with respect to said catheter and wherein said pushing means also includes means for contacting said transverse surface.

3. Apparatus in accordance with claim 1 wherein said holding means has a distal end and a proximal end opposite the distal end, said holding means including a pair of arms, said arms having mating grooves therein to receive and support said catheter means and said needle.

4. Apparatus in accordance with claim 3 wherein said holding means has first, second, and third positions, said first position longitudinally covering said catheter means and said needle, said second position exposing portions of said catheter means and said needle for insertion, said third position longitudinally covering said needle, said apparatus further including first and second means for locking said arms relative to said holding means when said holding means is in said first and second positions.

5. Apparatus in accordance with claim 4 including means for unlocking said arms relative to said holding means as said holding means is moved from said second position to said third position.

6. Apparatus in accordance with claim 5 wherein said catheter means includes first and second tubes with a connector therebetween and a coupler on an end of said second tube opposite said connector, said arms when unlocked having positions separable from one another to allow said connector and said coupler to move therebetween when said catheter means is separated from said holding means.

7. Apparatus in accordance with claim 1 wherein said holding means has first, second, and third positions, said first position longitudinally covering said catheter means and said needle, said second position exposing portions of said catheter means and said needle for insertion, said third position longitudinally covering said needle, said apparatus further including means for preventing movement of said holding means from said third position.

8. A catheter introducer assembly comprising:

a solid needle having a proximal end and a distal tip;

a catheter having a proximal end and a distal tip, the catheter being slidably received over the needle;

a first housing member, the proximal end of the needle being housed by and affixed to the first housing member;

a second housing member receivable over the distal tips of the needle and catheter, the first and second housing members being telescopably slidable between a first extended position whereat the distal tips of the needle and the catheter are enclosed within the second housing member and a second collapsed position whereat the distal tips of the needle and catheter are exposed, the first and second housing members having a combined length which is greater in the extended position than in the collapsed position.

9. The catheter introducer assembly of claim 8 further comprising rigid means affixed to the catheter for receiving a pushing force, the first housing member including means internally thereof for applying a pushing force to the rigid means of the catheter as the housing members are telescoped from the first position to the second position.

10. The catheter introducer assembly of claim 9, the rigid means of the catheter including wing members extending transversely relative to the catheter.

11. The catheter introducer assembly of claim 9, the rigid means of the catheter including a connector at the proximal end of the catheter.

12. The catheter introducer assembly of claim 8 wherein the catheter includes a connector at the proximal end, the assembly further comprising:

guide means releasably attached to the second housing member for guiding the needle and catheter out of the second housing member as the second housing member telescopes from the first to the second position.

13. The catheter introducer assembly of claim 8, the guide means normally defining an aperture smaller than the connector, the assembly further comprising means for enlarging the aperture whereby to allow the catheter connector to pass therethrough.

14. The catheter introducer assembly of claim 8 further comprising:

yieldable means for affixing the needle to the first housing member.

15. The catheter introducer assembly of claim 8, the catheter comprising a first tube of less flexible material and a second tube of more flexible material, said first and second tubes joined by a connector member and said first tube including said catheter distal tip and said second tube including said catheter proximal end.

16. The catheter introducer assembly of claim 15, the first tube of less flexible material extending from the connector member to the distal tip of the catheter, and the second tube of more flexible material extending from the connector member to the proximal end of the catheter.

17. The catheter introducer assembly of claim 15, the connector member including wing members extending transversely of the first and second tubes.

18. The catheter introducer assembly of claim 17, the first housing member including a handle portion and an internal shoulder at the distal end of the handle portion.

19. The catheter introducer assembly of claim 18, the internal shoulder abutting the wing members for applying a pushing force thereagainst as the housing members are telescoped from the first position to the second position.

20. The catheter introducer assembly of claim 8, the needle having a knife-like edge extending away from the distal tip.

21. The catheter introducer assembly of claim 20, the knife-like edge of the needle tip including burr portions.

22. The catheter introducer assembly of claim 8 wherein said second housing member includes stabilizing means for stabilizing the catheter and needle prior to and during insertion into a patient.

23. The catheter introducer assembly of claim 22, the stabilizing means being separable from the housing members and having a first orientation defining an aperture smaller than the connector member to retain the catheter at least partially within the first and second housing members, and a second orientation defining an aperture of sufficient size to permit removal of the catheter from the first and second housing members.

24. The catheter introducer assembly of claim 23, the stabilizing means comprising at least one arm having a groove for receiving the catheter and needle, the groove having sufficient length to provide radial support for the catheter and needle to prevent bending or kinking thereof during insertion in a patient, said at least one arm pivotally received in a respective longitudinal slot in the second housing member.

25. The catheter introducer assembly of claim 24 further comprising means for causing said at least one arm to pivot outwardly of the second housing member.

26. A catheter introducer assembly comprising:

a solid needle having a proximal end and a distal tip;

a catheter comprising a first tube of less flexible material including a catheter distal tip and a second tube of more flexible material including a catheter proximal end, said first and second tubes joined by a connector member, the catheter being slidably received over the needle;

a first housing member, the proximal end of the needle being housed by the first housing member;

a second housing member receivable over the distal tips of the needle and catheter and including stabilizing means for stabilizing the catheter and needle prior to and during insertion into a patient, the first and second housing members being telescopably slidable between a first extended position whereat the distal tips of the needle and catheter are enclosed within the second housing member and a second collapsed position whereat the distal tips of the needle and catheter are exposed.

27. The catheter introducer assembly of claim 26, the stabilizing means comprising a pair of arms having mating grooves for receiving the catheter and needle therebetween, the mating grooves having sufficient length to provide radial support for the catheter and needle to prevent bending or kinking thereof during insertion in a patient, each of the arms pivotally received in a respective longitudinal slot in the second housing member.

28. The catheter introducer assembly of claim 27 further comprising means for causing said arms to pivot outwardly of the second housing member.

29. The catheter introducer assembly of claim 27, the arms and the first housing member having cooperating radially extending flanges and corresponding longitudinal slots in which the flanges are slidably received as the housing members are telescoped from the first position to the second position.

30. The catheter introducer assembly of claim 29, the first housing member having a pair of channels formed therein and a pair of cantilever arms having a free end, each cantilever arm having inwardly extending ramp means at the free end thereof.

31. The catheter introducer assembly of claim 30, the second housing member having a pair of radially outwardly extending flanges slidably receivable in the channels in the first housing member, the flanges riding in the channels, biasing the cantilever arms outwardly as they ride on the ramp means, and positively locking the first and second housing members in a third extended position whereat the distal tip of the needle is enclosed within the second housing member.

32. A catheter introducer assembly comprising:

a solid needle having a proximal end and a distal tip;

a catheter having a proximal end and a distal tip, the catheter being slidably received over the needle;

a first sleeve member having a distal end portion; and

a second sleeve member having a distal end and a proximal end, the proximal end adapted to be telescopically slidable with respect to the distal end portion of the first sleeve member, the sleeve members having a first extended position with respect to one another wherein the sleeve members surround the needle and the catheter, the sleeve members having a collapsed position with respect to one another wherein the needle and the catheter extend outwardly from the distal end of the second sleeve, and the sleeves having a second extended position with respect to one another wherein the sleeves surround the needle after retraction of the needle from the catheter after introduction of the catheter, the first and second sleeve members having a combined length which is greater in the extended position than in the collapsed position.

33. The catheter introducer assembly of claim 32 further comprising locking means for locking the sleeves in the second extended position.