Intraparenchymal infusion catheter system

• US 6,594,880 B2
• Filed: 05/23/2001
• Issued: 07/22/2003
• Est. Priority Date: 04/28/1995
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Elsberry, Dennis D.
• Primary Examiner(s): Bryant, David P.
• Assistant Examiner(s): Cozart, Jermie E.
• Application Number:
  US09/864,646
• Publication Number:
  US 20010027599A1
• Time in Patent Office: 790 Days
• Field of Search: 294/47, 294/50, 604/8, 604/9, 604/19, 604/20, 604/48, 604/508, 604/510, 604/514, 604/515, 604/516, 604/517, 604/73, 604/93, 604/117, 604/123, 604/131, 604/264-266, 604/275, 604/523, 604/892.1, 604/506, 604/528, 604/530, 604/531, 604/533, 604/534-536, 128/DIG.12, 128/898
• US Class Current: 29/447
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]

Abstract

An intraparenchymal infusion catheter system for delivering drugs or other agents to selected sites in an organism, such as a human, includes a pump that may be implanted or disposed outside the organism. A catheter is coupled to the pump. The catheter comprises a flexible biocompatible tubular portion terminating in a free distal end. The distal end of the catheter bears a rounded tip, a portion of which is slidably disposed within the lumen of the tubular portion. The tip is porous for discharging an agent or drug to a selected site. The tip has a microporosity of less than or equal to 0.22 microns. The tubular portion is composed from a material that will expand from its nominal size when exposed to a stimulus such as heat or a solvent and return to its nominal size when the stimulus is withdrawn. By expanding the tubular portion, a physician can select the amount of the tip that is exposed to the organism, thereby customizing the catheter to the structural size of the selected site within the body.

Claims

1. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion formed having a lumen;

forming a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen to form an overlap with the first tubular portion;

adjusting the length of the second tubular portion to conform to the dimensions of a selected site in an organism; and

establishing a near zero tolerance fit between the overlap of second tubular portion and the first tubular portion;

wherein the step of adjusting the length of the second tubular portion comprises the steps of;

a) exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

b) sliding the second tubular portion in the lumen to obtain a preselected length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

c) ceasing to expose the first tubular portion to the solvent whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented.

2. The method of claim 1 wherein the step of adjusting the length of the second tubular portion is performed by a medical practitioner.

3. The method of claim 2 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for implantation into a patient.

4. The method of claim 3 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for intracerebral placement.

5. The method of claim 4 wherein the first tubular portion is sufficiently flexible to facilitate insertion into an implanted position within a patient.

6. The method of claim 5 wherein the first tubular portion is generally elastomeric.

7. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion formed having a lumen;

forming a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen to form an overlap with the first tubular portion;

adjusting the length of the second tubular portion to conform to the dimensions of a selected site in an organism; and

establishing a near zero tolerance fit between the overlap of the second tubular portion and the first tubular portion;

wherein the step of adjusting the length of the second tubular portion comprises the steps of;

a) exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

b) sliding the second tubular portion in the lumen to obtain a preselected length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

c) ceasing to expose the first tubular portion to the solvent whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

the first tubular portion including material selected from the group consisting of silicone or polyurethane;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to freon; and

the step of ceasing to expose the first tubular portion to the solvent whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

8. The method of claim 7 wherein the step of adjusting the length of the second tubular portion is performed by a medical practitioner.

9. The method of claim 8 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for implantation into a patient.

10. The method of claim 9 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for intracerebral placement.

11. The method of claim 10 wherein the first tubular portion is sufficiently flexible to facilitate insertion into an implanted position within a patient.

12. The method of claim 11 wherein the first tubular portion is generally elastomeric.

13. The method of claim 12 wherein the first tubular portion has a durometer value of approximately Shore 80.

14. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion formed having a lumen;

forming a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen to form an overlap with the first tubular portion;

adjusting the length of the second tubular portion to conform to the dimensions of a selected site in an organism; and

establishing a near zero tolerance fit between the overlap of the second tubular portion and the first tubular portion;

wherein the step of adjusting the length of the second tubular portion comprises the steps of;

a) exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

b) sliding the second tubular portion in the lumen to obtain a preselected length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

c) ceasing to expose the first tubular portion to the solvent whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to a solvent that will evaporate; and

the step of ceasing to expose the first tubular portion to the solvent whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

15. The method of claim 14 wherein the step of adjusting the length of the second tubular portion is performed by a medical practitioner.

16. The method of claim 15 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for implantation into a patient.

17. The method of claim 16 wherein the step (a) of adjusting the length of the second tubular portion is performed to customize the catheter for intracerebral placement.

18. The method of claim 17 wherein the first tubular portion is sufficiently flexible to facilitate insertion into an implanted position within a patient.

19. The method of claim 18 wherein the first tubular portion is generally elastomeric.

20. The method of claim 19 wherein the first tubular portion has a durometer value of approximately Shore 80.

21. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen;

forming second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a volatile solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent and allowing the solvent to evaporate such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented.

22. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen;

forming second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

wherein;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprises exposing the first tubular portion to a solvent that will evaporate; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprises allowing the solvent to evaporate.

23. The method of claim 22 wherein the step of adjusting the length of the second tubular portion is performed by a medical practitioner.

24. The method of claim 23 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for implantation into a patient.

25. The method of claim 24 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for intracerebral placement.

26. The method of claim 25 wherein the first tubular portion is sufficiently flexible to facilitate insertion into an implanted position within a patient.

27. The method of claim 26 wherein the first tubular portion is generally elastomeric.

28. The method of claim 27 wherein the first tubular portion has a durometer value of approximately Shore 80.

29. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen;

forming second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

the step of adjusting the length of the second tubular portion being performed by a medical practitioner.

30. The method of claim 29 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for implantation into a patient.

31. The method of claim 30 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for intracerebral placement.

32. The method of claim 31 wherein the first tubular portion is sufficiently flexible to facilitate insertion into an implanted position within a patient.

33. The method of claim 32 wherein the first tubular portion is generally elastomeric.

34. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen;

forming second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

the first tubular portion including material selected from the group consisting of silicone or polyurethane;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to freon; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

35. A method of manufacturing an implantable infusion pump and catheter system comprising the steps of:

providing an implantable infusion pump;

forming a catheter having;

a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen, and

a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a volatile solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion;

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent and allowing the solvent to evaporate such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented; and

coupling the catheter to the implantable infusion pump.

36. A method of manufacturing an implantable infusion pump and catheter system comprising the steps of:

providing an implantable infusion pump;

forming a catheter having;

a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen, and

a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion;

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented; and

coupling the catheter to the implantable infusion pump;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to a solvent that will evaporate; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

37. The method of claim 36 wherein the step of adjusting the length of the second tubular portion is performed by a medical practitioner.

38. The method of claim 37 wherein the step of adjusting the length of the second tubular portion is performed to customize the catheter for intracerebral placement.

39. The method of claim 38 wherein the first tubular portion is sufficiently flexible to facilitate insertion into an implanted position within a patient.

40. The method of claim 39 wherein the first tubular portion is generally elastomeric.

41. A method of manufacturing an implantable infusion pump and catheter system comprising the steps of:

providing an implantable infusion pump;

forming a catheter having;

a first tubular portion of a relatively impermeable material, the first tubular portion having a lumen, and

a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion;

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented; and

coupling the catheter to the implantable infusion pump;

the first tubular portion including material selected from the group consisting of silicone or polyurethane;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to freon; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

42. A method of manufacturing an implantable infusion pump and catheter system comprising the steps of:

providing an implantable infusion pump;

forming a catheter having;

a first tubular portion of a relatively impermeable material, the first tubular portion formed having a lumen; and

a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen to form an overlap with the first tubular portion;

adjusting the length of the second tubular portion to conform to the dimensions of a selected site in an organism by;

exposing the first tubular portion to a volatile solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a preselected length of the second tubular portion extending distally beyond the distal end of the first tubular portion;

establishing a near zero tolerance fit between the overlap of the second tubular portion and the first tubular portion by;

ceasing to expose the first tubular portion to the solvent and allowing the solvent to evaporate whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented; and

coupling the catheter to the implantable infusion pump.

43. A method of manufacturing an implantable infusion pump and catheter system comprising the steps of:

providing an implantable infusion pump;

forming a catheter having;

a first tubular portion of a relatively impermeable material, the first tubular portion formed having a lumen; and

a second tubular portion of a porous material;

partially disposing the second tubular portion within the lumen to form an overlap with the first tubular portion;

adjusting the length of the second tubular portion to conform to the dimensions of a selected site in an organism by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a preselected length of the second tubular portion extending distally beyond the distal end of the first tubular portion;

establishing a near zero tolerance fit between the overlap of the second tubular portion and the first tubular portion by;

ceasing to expose the first tubular portion to the solvent whereby the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented; and

coupling the catheter to the implantable infusion pump;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to a solvent that will evaporate; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

44. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion having a lumen;

forming second tubular portion;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a volatile solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent and allowing the solvent to evaporate such that the diameter of the tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented.

45. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion having a lumen;

forming second tubular portion;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to a solvent that will evaporate; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.

46. A method of manufacturing a catheter comprising the steps of:

forming a first tubular portion having a lumen;

forming second tubular portion;

partially disposing the second tubular portion within the lumen;

adjusting the length of the second tubular portion by;

exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen;

sliding the second tubular portion in the lumen to obtain a desired length of the second tubular portion extending distally beyond the distal end of the first tubular portion; and

immobilizing the second tubular portion and the first tubular portion relative to each other by;

ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented;

the first tubular portion including material selected from the group consisting of silicone or polyurethane;

the step of exposing the first tubular portion to a solvent that increases the diameter of the lumen a sufficient amount to permit relative sliding movement of the second tubular portion in the lumen comprising exposing the first tubular portion to freon; and

the step of ceasing to expose the first tubular portion to the solvent such that the diameter of the first tubular portion decreases until relative sliding movement between the first tubular portion and the second tubular portion is prevented comprising allowing the solvent to evaporate.