Implantable medical device having pre-implant exoskeleton

• US 20050154437A1
• Filed: 12/10/2004
• Published: 07/14/2005
• Est. Priority Date: 12/12/2003
• Status: Active Grant

• Current Assignee: Interventional Autonomics Corporation
• Original Assignee: Synecor LLC
• Inventors: Williams, Michael S.
• Granted Patent: US 7,747,335 B2
• Time in Patent Office: Days
• US Class Current: 607/123
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37516 Intravascular implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation

Abstract

The present application describes a method and apparatus for implanting a medical device within a living body. The apparatus includes an elongate sleeve positionable with a living body, such as within a blood vessel, and a medical device insertable into the sleeve. During use, the sleeve is retained with the body, and the medical device is sealed within the sleeve. The sleeve substantially avoids biological growth onto the medical device, and thus permits removal of the medical device independently of the sleeve.

Claims

1. A method of implanting a medical device within a living body, the method comprising the steps of:

forming an incision in a living body;

introducing a sleeve having a length through the incision;

positioning the entire length of the sleeve within the body;

inserting an implantable medical device into the sleeve and sealing the medical device within the sleeve.

2. The method of claim 1, wherein the positioning step positions at least a portion of the sleeve within a blood vessel.

3. The method of claim 1, wherein the inserting step is performed prior to the introducing step.

4. The method of claim 1, wherein the inserting step is performed after the introducing step.

5. The method of claim 2, further including the step of anchoring the sleeve within the blood vessel.

6. The method of claim 5, wherein the sleeve includes an expandable retention device, and wherein the anchoring step includes the step expanding the retention device into contact with walls of the vessel.

7. The method of claim 2, wherein the positioning step positions the entire length of the sleeve within the blood vessel.

8. The method of claim 1, wherein the medical device is removable from the sleeve while the sleeve remains within the body

9. The method of claim 1, wherein the sealing step attaches a sealing device to the sleeve.

10. The method of claim 9, wherein the sealing step attaches a cap or plug to the sleeve.

11. The method of claim 9, wherein the sealing step applies a sealing compound to the sleeve.

12. The method of claim 1, wherein after the sealing step, the sleeve substantially prevents body fluids surrounding the sleeve from contacting the medical device.

13. The method of claim 1, wherein after the sealing step, the sleeve substantially prevents biological growth onto the medical device.

14. The method of claim 1, wherein

the introducing step introduces a sleeve having an exterior and at least one electrode on the exterior;

the sealing inserting step inserts a medical device having an interior and pulse generator sealed within the interior; and

the method further includes the step of electrically coupling the pulse generator to the electrode.

15. The method of claim 14, wherein the sleeve includes a side branch extending from the sleeve, wherein the method includes positioning the side branch within the heart.

16. The method of claim 15, wherein at least one electrode is a branch electrode positioned on the side branch, and wherein the electrically coupling step couples the branch electrode to the pulse generator.

17. The method of claim 1, wherein:

the introducing step introduces a sleeve having a fluid delivery port;

the inserting step inserts a medical device having an interior and a fluid reservoir in the interior; and

the method further includes the step of fluidly coupling the fluid delivery port and the fluid reservoir.

18. The method of claim 1, wherein the method is further for explanting the medical device, and wherein the method includes the steps of:

withdrawing a portion of the sleeve from the body; and

extracting the medical device from within the sheath.

19. The method of claim 18, further including the step of:

after the extracting step, inserting a second medical device into the sleeve.

20. The method of claim 1, further include the step of allowing the incision to heal, leaving the medical device and the sleeve within the body.

21. A implantable intravascular medical system including:

a elongate sleeve proportioned for implantation within a blood vessel of a patient; and

an implantable medical device positionable within the sleeve, the medical device including a housing and a pulse generator sealed within the housing.

22. The system of claim 21, wherein:

the sleeve includes an interior and an exterior surface, at least one electrode on the exterior surface, and a contact positioned in the interior and electrically coupled to the electrode; and

the implantable medical device includes an outer surface and a conductive element on the outer surface and electrically coupled to the pulse generator, wherein the conductive element is positioned to electrically couple to the contact on the sleeve when the implantable medical device is positioned within the sleeve.

23. The system of claim 21, wherein the implantable medical device is a defibrillation device.

24. The system of claim 21, wherein the implantable medical device is a pacemaker.

25. The system of claim 21, wherein the implantable medical device is a cardioverter.

26. The system of claim 21, wherein the sleeve includes an opening, wherein the implantable medical device is insertable into the sleeve through the opening, and wherein the system further includes a seal positionable in the opening to seal the opening against body fluids.

27. The system of claim 26, wherein the sleeve includes a side branch extending from the sleeve, wherein at least one electrode is positioned on the side branch.

28. The system of claim 21, further including an anchor on the sleeve, the anchor expandable into contact with the walls of the blood vessel to retain the sleeve therein.

29. The system of claim 26, wherein the sleeve includes a distal section and a proximal section, wherein the proximal section is more flexible than the distal section, and wherein the opening is formed in the proximal section.

30. The system of claim 21, wherein the sleeve is constructed to prevent biological growth onto the medical device when the sleeve and medical device are implanted in a blood vessel.

31. A implantable intravascular medical system including:

a elongate sleeve proportioned for implantation within a blood vessel in a body of a patient; and

an implantable medical device positionable within the sleeve, the medical device including a drug reservoir, a delivery port fluidly coupled to the drug reservoir, and a pump positioned to pump drug stored in the drug reservoir out the delivery port.

32. The system of claim 31, wherein:

the sleeve includes an interior and an exit orifice fluidly coupled to the interior; and

the delivery port of the implantable medical device is positioned to fluidly couple to the exit orifice of the sleeve when the implantable medical device is positioned within the sleeve.

33. The system of claim 31, wherein the sleeve includes an opening, wherein the implantable medical device is insertable into the sleeve through the opening, and wherein the system further includes a seal positionable in the opening to seal the opening against body fluids.

34. The system of claim 31, further including an anchor on the sleeve, the anchor expandable into contact with the walls of the blood vessel to retain the sleeve therein.

35. The system of claim 33, wherein the sleeve includes a distal section and a proximal section, wherein the proximal section is more flexible than the distal section, and wherein the opening is formed in the proximal section.

36. The system of claim 31, wherein:

the implantable medical device includes a fill tube fluidly coupled to the drug reservoir; and

a port fluidly coupled to the fill tube, the port accessible from outside the body.

37. The system of claim 36, wherein:

the system includes a vessel containing a volume of a drug, the vessel enageable with the port for fluid communication with the fill tube.

38. The system of claim 37, wherein the vessel comprises a having a needle tip sufficiently sharpened to penetrate the patient'"'"'s skin for access to the port.

39. The system of claim 37, wherein the fill tube is fully disposed within the sleeve, and wherein the fill tube and sleeve have sufficient length to extend outside the body, and wherein the vessel and port are engageable outside the body.

40. The system of claim 31, wherein the sleeve is constructed to prevent biological growth onto the medical device when the sleeve and medical device are implanted in a blood vessel.

41. An implantable intravascular medical system kit, including:

a elongate sleeve proportioned for implantation within a blood vessel of a patient;

an implantable medical device positionable within the sleeve; and

instructions for use setting forth implantation methods for the sleeve and medical device, including the steps of;

forming an incision in a living body;

introducing the sleeve through the incision and into a blood vessel;

positioning an entire length of the sleeve within the body;

inserting the medical device into the sleeve and sealing the medical device within the sleeve.