Implantable electronic device employing coated lead retaining setscrews

• US 10,639,484 B2
• Filed: 10/19/2017
• Issued: 05/05/2020
• Est. Priority Date: 10/19/2017
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bilu, Avi, Choi, Daniel, Dadashian, Asghar
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/788,239
• Publication Number:
  US 20190117981A1
• Time in Patent Office: 929 Days
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: B05D 1/60 Deposition of organic layers from vapour phase vapour phase deposition in general C23C14/00, C23C16/00
• CPC Class Codes: B05D 2258/00 Small objects (e.g. screws)
• CPC Class Codes: B05D 3/102 Pretreatment of metallic substrates C23C takes precedence

Abstract

Disclosed herein is an implantable electronic device for use with implantable medical leads. The implantable medical leads are retained within the implantable electronic device with coated setscrews and, in particular, setscrews having a vapor-deposited coating, such as parylene. The coated setscrews have improved thread locking capabilities that resist unscrewing once tightened and, as a result, improve retention of implantable leads within the implantable electronic device.

Claims

1. An implantable electronic device for use with an implantable medical lead, the implantable medical lead including a proximal lead end, the implantable electronic device comprising:

a housing;

a header connector assembly coupled to the housing and defining a threaded setscrew bore, the header connector assembly comprising a connector assembly adjacent the threaded setscrew bore, the connector assembly adapted to receive the proximal lead end of the implantable medical lead; and

a setscrew threadedly movable within the threaded setscrew bore to retain the proximal lead end within the connector assembly, the setscrew comprising;

an anodized threaded body and a vapor-deposited coating disposed on a threaded portion of the anodized threaded body, the anodized threaded body defining a socket that is not coated by the vapor-deposited coating and that extends into the anodized threaded body, the socket shaped to receive a tool adapted to rotate the setscrew within the threaded setscrew bore.

2. The implantable electronic device of claim 1, wherein the vapor-deposited coating is a poly(p-xylelene) polymer coating.

3. The implantable electronic device of claim 2, wherein the vapor-deposited coating is a parylene coating.

4. The implantable electronic device of claim 1, wherein the vapor-deposited coating has a thickness from and including 0.0001 inches to and including 0.005 inches.

5. The implantable electronic device of claim 1, wherein the setscrew is formed from a substrate material selected from a group of substrate materials including titanium and stainless steel.

6. The implantable electronic device of claim 1, wherein the anodized threaded body comprises a thread having a pitch from and including 0.0125 inches to and including 0.2222 inches and a pitch diameter from and including 0.060 inches in to and including 2.00 inches.

7. The implantable electronic device of claim 1, wherein the torque required to rotate the setscrew within the threaded setscrew bore is from and including 0.2 ounce-inches to and including 2.0 ounce-inches.

8. A method of manufacturing an implantable electronic device including a header that further includes a connector assembly and a threaded setscrew bore adjacent the connector assembly, the method comprising:

producing a coated setscrew by applying a vapor-deposited coating to threads of an anodized setscrew substrate, the anodized setscrew substrate including a socket that is not coated by the vapor-deposited coating and that extends into the anodized setscrew substrate, the socket shaped to receive a tool adapted to rotate the setscrew within the threaded setscrew bore; and

at least one of providing the coated setscrew with the implantable electronic device or threadedly engaging the coated setscrew within the threaded setscrew bore.

9. The method of claim 8, wherein the vapor-deposited coating is a poly(p-xylelene) polymer.

10. The method of claim 9, wherein the vapor-deposited coating is parylene.

11. The method of claim 8, wherein the vapor-deposited coating is has a thickness from and including 0.0002 inches to and including 0.005 inches.

12. The method of claim 8 further comprising applying a primer to the anodized setscrew substrate before applying the vapor-deposited coating.

13. The method of claim 12, wherein the primer includes silane.

14. The method of claim 8 further comprising masking a portion of the anodized setscrew substrate such that the vapor-deposited coating is not applied to the masked portion of the anodized setscrew substrate.

15. The method of claim 14, wherein masking the portion of the setscrew comprises applying at least one of a masking dot, tape, a contact pad, and a masking solution to the portion of the setscrew.

16. The method of claim 8, wherein the method further comprises supporting the setscrew on a fixture shaped to be inserted into the socket such that the fixture prevents application of the vapor-deposited coating to the socket.