IP Library Granted Patent US 12,161,873
Granted Patent B2
US 12,161,873 · App. 17/384,193 · Granted Dec 10, 2024

Header connection system for implantable medical device

Inventors: Scott Carter (Orchard Park, NY); Luis Daniel Villamil (Montevideo, UY)
Assignee: Greatbatch Ltd.
A61N1/3752
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Quick Facts
Patent No.
US 12,161,873
App. No.
17/384,193
Granted
Dec 10, 2024
Kind
B2
Abstract

In various examples, a header of an implantable device includes a first header portion and a second header portion at least partially disengageable from the first header portion. In a closed configuration, the first header portion is fully engaged with the second header portion, and in an open configuration, the first header portion is at least partially disengaged from the second header portion. At least one bore within the header is sized and shaped to accommodate a proximal end of a lead. The bore is split substantially longitudinally to form a first bore portion and a second bore portion. With the proximal end of the lead disposed within the bore and a positioning feature interacting with a lead feature, at least one lead contact aligns with at least one header contact to allow the at least one lead contact to electrically couple to the at least one header contact.

Claims (50)

1. A header of an implantable device, the implantable device including a housing and a lead, the housing including electronics disposed within the housing, the lead including an elongate body with a proximal end and a distal end, the lead including at least one lead contact proximate the proximal end and at least one lead electrode proximate the distal end, the header comprising:

a first header portion;

a second header portion at least partially disengageable from the first header portion, wherein the header includes:

a closed configuration in which the first header portion is fully engaged with the second header portion; and

an open configuration in which the first header portion is at least partially disengaged from the second header portion;

at least one bore within the header sized and shaped to accommodate the proximal end of the lead, the bore including a bore opening in a wall of the header, the bore being split substantially longitudinally to form a first bore portion and a second bore portion, the first bore portion forming a first channel disposed within the first header portion and including a first channel opening in a first surface of the first header portion along a length of the first channel, and the second bore portion forming a second channel disposed within the second header portion and including a second channel opening in a second surface of the second header portion along a length of the second channel;

at least one header contact disposed within the bore and configured to electrically couple to the lead contact with the proximal end of the lead disposed within the bore; and

a positioning feature disposed within the bore, the positioning feature configured to interact with a corresponding lead feature proximate the proximal end of the lead, wherein, with the proximal end of the lead disposed within the bore and the positioning feature interacting with the lead feature, the at least one lead contact aligns with the at least one header contact to allow the at least one lead contact to electrically couple to the at least one header contact, wherein:

with the header in the open configuration, the length of the first channel is accessible to allow the lead to be inserted laterally into the first channel through the first channel opening; and

with the header in the closed configuration, the first surface of the first header portion abuts the second surface of the second header portion so that the first bore portion and the second bore portion form the bore accessible only through the bore opening in the wall of the header, such that, with the proximal end of the lead disposed within the bore, the elongate body of the lead extends distally from the bore opening.

2. The header of claim 1 , wherein the positioning feature includes a pin disposed within the bore and the lead feature includes a corresponding hole within the lead proximate the proximal end of the lead, the hole being complementary to the pin, such that, with the proximal end of the lead disposed within the bore and the pin disposed within the hole of the lead, the lead is positioned within the bore to allow the at least one lead contact to align with and electrically couple to the at least one header contact.

3. The header of claim 1 , wherein the positioning feature includes a protrusion disposed within the bore and the lead feature includes a corresponding indentation within the lead proximate the proximal end of the lead, the indentation being complementary to the protrusion, such that, with the proximal end of the lead disposed within the bore and the protrusion disposed within the indentation of the lead, the lead is positioned within the bore to allow the at least one lead contact to align with and electrically couple to the at least one header contact.

4. The header of claim 3 , wherein the protrusion includes a bump extending into the bore and the indentation includes a notch within the lead.

5. The header of claim 3 , wherein the protrusion includes one or more radially-extending bumps extending into and disposed at least partially around the bore and the indentation includes a groove disposed within and extending at least partially radially around the lead.

6. The header of claim 1 , wherein the at least one header contact includes a spring.

7. The header of claim 1 , wherein the at least one header contact includes a spring contact.

8. The header of claim 1 , comprising a seal member including a first seal portion disposed within the first bore portion of the first header portion and a second seal portion disposed within the second bore portion of the second header portion, wherein, with the header in the closed configuration and the proximal end of the lead within the bore, the first seal portion abuts the second seal portion, and the first seal portion and the second seal portion extend into the bore to abut the elongate body of the lead.

9. The header of claim 1 , wherein the first header portion is pivotably coupled to the second header portion, such that the second header portion is rotatable with respect to the first header portion from being fully engaged with the first header portion in the closed configuration to being partially disengaged from the first header portion in the open configuration.

10. The header of claim 9 , wherein the first header portion is pivotably coupled to the second header portion at a hinge.

11. The header of claim 1 , wherein the first header portion is removably coupled to the second header portion, such that the second header portion is fully engaged with the first header portion in the closed configuration and fully disengaged and removed from the first header portion in the open configuration.

12. The header of claim 11 , wherein the first header portion is removably coupled to the second header portion using securement members.

13. An implantable device comprising:

a housing including electronics disposed within the housing;

a lead including an elongate body with a proximal end and a distal end, the lead including at least one lead contact proximate the proximal end and at least one lead electrode proximate the distal end; and

a header attached to the housing, the header configured to engage with the lead and electrically couple the lead to the electronics disposed within the housing, the header including:

a first header portion;

a second header portion at least partially disengageable from the first header portion, wherein the header includes:

a closed configuration in which the first header portion is fully engaged with the second header portion; and

an open configuration in which the first header portion is at least partially disengaged from the second header portion;

at least one bore within the header sized and shaped to accommodate the proximal end of the lead, the bore including a bore opening in a wall of the header, the bore being split substantially longitudinally to form a first bore portion and a second bore portion, the first bore portion forming a first channel disposed within the first header portion and including a first channel opening in a first surface of the first header portion along a length of the first channel, and the second bore portion forming a second channel disposed within the second header portion and including a second channel opening in a second surface of the second header portion along a length of the second channel;

at least one header contact disposed within the bore and configured to electrically couple to the lead contact with the proximal end of the lead disposed within the bore; and

a positioning feature disposed within the bore, the positioning feature configured to interact with a corresponding lead feature proximate the proximal end of the lead, wherein, with the proximal end of the lead disposed within the bore and the positioning feature interacting with the lead feature, the at least one lead contact aligns with the at least one header contact to allow the at least one lead contact to electrically couple to the at least one header contact, wherein:

with the header in the open configuration, the length of the first channel is accessible to allow the lead to be inserted laterally into the first channel through the first channel opening; and

with the header in the closed configuration, the first surface of the first header portion abuts the second surface of the second header portion so that the first bore portion and the second bore portion form the bore accessible only through the bore opening in the wall of the header, such that, with the proximal end of the lead disposed within the bore, the elongate body of the lead extends distally from the bore opening.

14. The implantable device of claim 13 , wherein the positioning feature includes a pin disposed within the bore and the lead feature includes a corresponding hole within the lead proximate the proximal end of the lead, the hole being complementary to the pin, such that, with the proximal end of the lead disposed within the bore and the pin disposed within the hole of the lead, the lead is positioned within the bore to allow the at least one lead contact to align with and electrically couple to the at least one header contact.

15. The implantable device of claim 13 , wherein the positioning feature includes a protrusion disposed within the bore and the lead feature includes a corresponding indentation within the lead proximate the proximal end of the lead, the indentation being complementary to the protrusion, such that, with the proximal end of the lead disposed within the bore and the protrusion disposed within the indentation of the lead, the lead is positioned within the bore to allow the at least one lead contact to align with and electrically couple to the at least one header contact.

16. The implantable device of claim 15 , wherein the protrusion includes a bump extending into the bore and the indentation includes a notch within the lead.

17. The implantable device of claim 13 , wherein the header includes a seal member including a first seal portion disposed within the first bore portion of the first header portion and a second seal portion disposed within the second bore portion of the second header portion, wherein, with the header in the closed configuration and the proximal end of the lead within the bore, the first seal portion abuts the second seal portion, and the first seal portion and the second seal portion extend into the bore to abut the elongate body of the lead.

18. The implantable device of claim 13 , wherein the first header portion is pivotably coupled to the second header portion, such that the second header portion is rotatable with respect to the first header portion from being fully engaged with the first header portion in the closed configuration to being partially disengaged from the first header portion in the open configuration.

19. The implantable device of claim 13 , wherein the first header portion is removably coupled to the second header portion, such that the second header portion is fully engaged with the first header portion in the closed configuration and fully disengaged and removed from the first header portion in the open configuration.

20. A header of an implantable device, the header comprising:

a first header portion;

a second header portion at least partially disengageable from the first header portion, wherein the header includes:

a closed configuration in which the first header portion is fully engaged with the second header portion; and

an open configuration in which the first header portion is at least partially disengaged from the second header portion;

at least one bore within the header sized and shaped to accommodate a proximal end of a lead, the bore including a bore opening in a wall of the header, the bore being split substantially longitudinally to form a first bore portion and a second bore portion, the first bore portion forming a first channel disposed within the first header portion and including a first channel opening in a first surface of the first header portion along a length of the first channel, and the second bore portion forming a second channel disposed within the second header portion and including a second channel opening in a second surface of the second header portion along a length of the second channel;

at least one header contact disposed within the bore and configured to electrically couple to a lead contact with the proximal end of the lead disposed within the bore; and

a positioning feature disposed within the bore, the positioning feature configured to interact with a corresponding lead feature proximate the proximal end of the lead, wherein:

with the header in the open configuration, the length of the first channel and the length of the second channel are accessible to allow a lead to be inserted laterally into either the first channel through the first channel opening or the second channel through the second channel opening; and

with the header in the closed configuration, the first surface of the first header portion abuts the second surface of the second header portion so that the first bore portion and the second bore portion form the bore accessible only through the bore opening in the wall of the header.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2024
From: CARTER, SCOTT; VILLAMIL, LUIS DANIEL
To: GREATBATCH LTD.
Reel/Frame 068294/0411 →
SECURITY INTEREST Recorded Sep 10, 2021
From: GREATBATCH LTD.; ELECTROCHEM SOLUTIONS, INC.; LAKE REGION MEDICAL, INC.; LAKE REGION MANUFACTURING, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 057468/0056 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2021
From: CARTER, SCOTT; VILLAMIL, LUIS DANIEL
To: GREATBATCH LTD.
Reel/Frame 056965/0049 →