Method and device for insertion and implantation of a subcutaneous electrode

• US 20020107559A1
• Filed: 11/05/2001
• Published: 08/08/2002
• Est. Priority Date: 09/18/2000
• Status: Active Grant

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Sanders, Gary H., Bardy, Gust H.
• Granted Patent: US 7,090,682 B2
• Time in Patent Office: Days
• US Class Current: 607/129
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

There is provided in one aspect of the present invention an assembly for subcutaneous implantation in a patient including a lead electrode assembly having an opening and an introducer disposed within the opening of the housing. Another aspect of the invention is an extractor for extracting a lead electrode assembly subcutaneously implanted in a patient, including an insertion portion for insertion into an opening in the lead electrode assembly, and a handle assembly connected to the insertion portion.

Claims

1. An assembly for subcutaneous implantation in a patient comprising:

a lead electrode assembly having an opening;

an introducer disposed within the opening of the housing.

2. The assembly of claim 1, wherein the lead electrode assembly further comprises a housing.

3. The assembly of claim 1, wherein the lead electrode assembly further comprises an electrical connector.

4. The assembly of claim 3, wherein the electrical connector further comprises two or more electrical contacts.

5. The assembly of claim 4, wherein the housing comprises a polymeric material.

6. The assembly of claim 5, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

7. The assembly of claim 1, wherein the introducer further comprises a handle.

8. An extractor for extracting a lead electrode assembly subcutaneously implanted in a patient, comprising:

an insertion portion for insertion into an opening in the lead electrode assembly; and

a handle assembly connected to the insertion portion.

9. The extractor of claim 8, wherein the handle assembly further comprises a gripping assembly.

10. The extractor of claim 9, wherein the gripping assembly further comprises a wedge connected to the handle and two prongs;

and

wherein the wedge is positioned to separate the two prongs when the handle assembly is moved away from the insertion portion.

11. The extractor of claim 10, wherein the two prongs further comprise a barb-shaped outside portion for contact with the opening of the lead electrode assembly.

12. The extractor of claim 9, wherein the extractor further comprises a covering disposed around the insertion device.

13. The extractor of claim 8, wherein the insertion portion comprises a polymeric material.

14. The extractor of claim 13, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

16. The method of claim 15, wherein the step of creating a subcutaneous path outside the ribcage further comprises:

creating an incision in the thoracic region of the patient.

17. The method of claim 15, wherein the lead electrode assembly further comprises an electrical connector.

18. The method of claim 17, wherein the electrical connector further comprises two or more electrical contacts.

19. The method of claim 18, wherein the housing comprises a polymeric material.

20. The method of claim 19, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

21. The method of claim 15, wherein the introducer further comprises a handle.

15. A method of surgically implanting a lead electrode assembly subcutaneously outside a patient'"'"'s ribcage, the method comprising:

creating a subcutaneous path outside the ribcage

inserting an introducer into the lead electrode assembly;

inserting the introducer and the lead electrode assembly into the subcutaneous path; and

removing the introducer from the lead electrode assembly.

22. A method of extracting a lead electrode assembly subcutaneously implanted in a patient, comprising:

inserting an extractor into an opening in the lead electrode assembly; and

removing the extractor and the lead electrode assembly from the patient.

23. The method of claim 22, wherein the extractor further comprises a handle assembly.

24. The method of claim 22, wherein the extractor further comprises a gripping assembly.

25. The method of claim 24, wherein the gripping assembly further comprises a wedge connected to the handle and two or more prongs;

and

wherein the wedge is positioned to separate the two prongs when the handle assembly is moved away from the insertion portion.

26. The method of claim 25, wherein each of the two or more prongs further comprises a barb-shaped outside portion for contact with the opening of the lead electrode assembly.

27. The method of claim 22, wherein the extractor further comprises a covering disposed around the insertion device.

28. The method of claim 22, wherein the extractor further comprises an insertion portion that comprises a polymeric material.

29. The method of claim 28, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.