Method of fabricating implantable medical devices from a polymer coupon that is bonded to rigid substrate

• US 9,700,262 B2
• Filed: 02/06/2015
• Issued: 07/11/2017
• Est. Priority Date: 05/17/2011
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Janik, John, Tang, Edward Chia-Ning, Brindley, Robert
• Primary Examiner(s): Vinh, Lan
• Application Number:
  US14/615,547
• Publication Number:
  US 20150150504A1
• Time in Patent Office: 886 Days
• Field of Search: 216 33, 216 34, 216 35, 216 40, 216 41, 216 56, 216 20, 438106166
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: H01L 23/5389 the chips being integrally enclosed by the interconnect and support structures
• CPC Class Codes: H01L 24/19 Manufacturing methods of high density interconnect preforms

Abstract

Plural medical device formed from one or more layers of thin film polymer are assembled from a single polymer coupon. Initially the coupon is bonded to a rigid substrate. Force, heat and a suction are selectively applied to the coupon to ensure that it has a consistent height across its exposed surface. Once the polymer coupon is bonded the components forming the medical device are attached to the coupon and the coupon is shaped to form the individual medical devices. Shaped sections of the coupon are then lifted off the rigid backing. The lifted off sections on which the components were attached are the medical devices.

Claims

1. A method of assembling plural medical devices for implantation on or in a living being, said method including the steps of:

bonding a first flexible polymer coupon formed from biocompatible material to a first rigid backing, said bonding step including the sub-steps of;

applying an adhesive layer to an exposed face of the first rigid backing;

placing the first polymer coupon on the first rigid backing;

applying a force against the first polymer coupon to urge the coupon against the first rigid backing;

while performing said step of applying the force against the first polymer coupon, drawing a suction below ambient pressure on the first polymer coupon and the first rigid backing;

while performing said step of applying a force against the first polymer coupon and said step of drawing a suction on the first polymer coupon and the first rigid backing, heating the first polymer coupon and the rigid backing;

decreasing the temperature of the first polymer coupon and the first rigid backing;

after the temperature of the first polymer coupon and the first rigid backing is allowed to decrease, terminating said step of drawing a suction on the polymer coupon and the rigid backing and terminating said step of applying a force against the first polymer coupon;

attaching plural components to an exposed face of the first polymer coupon, the components able to provide a therapeutic benefit and/or offer diagnostic information;

while the first polymer coupon remains attached the first rigid backing, bonding an additional layer of polymer over the exposed face of the first polymer coupon;

while the first polymer coupon and attached components remain attached to said first rigid backing, separating the first polymer coupon into at least two sections, wherein each section has at least one component able to provide a therapeutic benefit or perform a diagnostic function;

shaping the additional layer of polymer disposed over the at least two sections of the first polymer coupon that have a component able to provide a therapeutic benefit or perform a diagnostic function so that each section forms a polymer laminate consisting of a portion of the first polymer coupon and a portion of the additional layer of polymer to which at least one component able to provide a therapeutic benefit or perform a diagnostic function is attached;

after said step of separating the first polymer coupon into the at least two sections, dissolving the adhesive layer between the first polymer coupon and the first rigid backing; and

after said step of dissolving the adhesive layer, lifting off the polymer laminates to which the components are attached from the first rigid backing, the lifted off polymer laminates and attached components forming plural medical devices.

2. The method of assembling medical devices of claim 1, wherein, during said first polymer coupon bonding step, said sub-step of applying a force against the first polymer coupon is initiated prior to initiating said step of drawing the suction on the first polymer coupon and the first rigid backing.

3. The method of assembling medical devices of claim 1, wherein said step of separating the first polymer coupon into separate sections is performed after said step of attaching the plural components to the first polymer coupon.

4. The method of assembling medical devices of claim 1, wherein after said step of drawing a suction on the first polymer coupon and the first rigid backing is terminated so that the first coupon and the first rigid backing return to an ambient pressure, said step of applying a force to the first polymer coupon is terminated.

5. The method of assembling medical devices of claim 1, wherein said step of separating the first polymer coupon into plural sections is performed by cutting the coupon or etching away portions of the coupon to define the separate sections of the coupon.

6. The method of assembling medical devices of claim 1, wherein said step of attaching components to the first polymer coupon includes:

forming voids in the first polymer coupon that extend inwardly from the exposed face of the first polymer coupon; and

positioning or forming the components in the voids formed in the first polymer coupon.

7. The method of assembling medical devices of claim 1, wherein, while the first polymer coupon is bonded to the first rigid backing, at least one slot is formed in at least one section of the coupon that becomes part of a medical device so that, when the polymer laminate with the section is lifted off from the first rigid backing, at least one medical devices is formed to have slot that extends at least partially through the medical device.

8. The method of assembling medical devices of claim 1, wherein in said step of attaching components to the first polymer coupon, components are attached to the coupon so that the lifted off polymer laminates and attached components form plural implantable electrode arrays.

9. The method of assembling medical devices of claim 1, wherein the first polymer coupon is a liquid crystal polymer.

10. The method of assembling medical devices of claim 1, wherein the first polymer coupon has a maximum thickness of 1 mm.

11. The method of assembling medical devices of claim 1, wherein, said step of shaping the first polymer coupon into at least two sections and said step of shaping the additional layer of polymer disposed over the at least two sections of the first polymer coupon are performed as single step.

12. The method of assembling plural medical devices of claim 1, where said step of bonding an additional layer of polymer to the first polymer coupon is performed by:

bonding a second polymer coupon to a second rigid backing;

bonding the second polymer coupon to the first polymer coupon so that, in said step of bonding the second polymer coupon to the first polymer coupon, an exposed face of the second polymer coupon opposite the second rigid backing is bonded to the exposed face of the first polymer coupon; and

after said step of bonding the second polymer coupon to the first polymer coupon, the second rigid backing is removed from the second polymer coupon.

13. The method of assembling plural medical devices of claim 1, wherein:

prior to said step of bonding the additional layer of polymer over the first polymer coupon, at least one stiffening member that increases the rigidity of the polymer is attached to the first polymer coupon;

after said step of attaching the at least one stiffening member to the first polymer coupon, said step of bonding the additional layer of polymer of the first polymer coupon is performed so the additional layer of polymer is disposed over the at least one stiffening member; and

said step of separating the first polymer coupon and said step of shaping the additional polymer layer of polymer are performed so that the at least one stiffening member is contained in one of the polymer laminates that form a medical device.

14. The method of assembling plural medical devices of claim 1, wherein said step of shaping the additional layer of polymer disposed over the first polymer coupon is performed prior to said step of bonding the additional layer of polymer to the first polymer coupon.

15. The method of assembling medical devices of claim 1, wherein:

while said first polymer coupon remains attached to the first rigid coupon, attaching at least one stiffening member that increases the rigidity of the polymer of the first polymer coupon; and

in said step of shaping the first polymer coupon, shaping the first polymer coupon so the at least one stiffening member is part of one of the polymer laminates that becomes medical device.

16. The method of assembling medical devices of claim 15, wherein, in said step of attaching at least one stiffening member to the first polymer coupon, the first polymer coupon is heated so as to a level sufficient to cause the semi-liquefaction of the exposed surface of the polymer coupon so that the polymer coupon interlocks with the at least one stiffening member.

17. A method of assembling plural medical devices for implantation on or in a living being, said method including the steps of:

bonding a first flexible polymer coupon formed from biocompatible material to a first rigid backing, said bonding step including the sub-steps of;

applying an adhesive layer to an exposed face of the first rigid backing;

placing the first polymer coupon on the first rigid backing;

applying a force against the first polymer coupon to urge the coupon against the first rigid backing,

while performing said step of applying the force against the first polymer coupon, drawing a suction below ambient pressure levels on the first polymer coupon and the first rigid backing;

while performing said step of applying a force against the first polymer coupon and said step of drawing a suction on the first polymer coupon and the first rigid backing, heating the polymer coupon and the rigid backing;

allowing the temperature of the first polymer coupon and the first rigid backing to decrease;

after the temperature of the first polymer coupon is allowed to decrease;

terminating said step of drawing a suction on the first polymer coupon and the first rigid backing and said step of applying a force against the first rigid backing;

while the first polymer coupon remains bonded to the first rigid backing, forming plural spaced apart slots in the first polymer coupon that extend inwardly from an exposed face of the first polymer coupon;

while the first polymer coupon remains bonded to the first rigid backing, affixing plural components to the first polymer coupon, the components able to provide a therapeutic benefit and/or offer diagnostic information;

while the first polymer coupon remains attached the first rigid backing, bonding an additional layer of polymer over the exposed face of the first polymer coupon, wherein the additional layer of polymer is formed with slots that are in registration with the slots in the first polymer coupon;

while the first polymer coupon and attached components remain attached to said first rigid backing, separating the first polymer coupon into at least two separate sections, where each section including at least one of the voids formed in the polymer coupon and each section having at least one component able to provide a therapeutic benefit or perform a diagnostic function and containing one of the slots formed in the first polymer coupon;

shaping the additional layer of polymer disposed over the at least two sections of the first polymer coupon that have a component able to provide a therapeutic benefit or perform a diagnostic function so that each section forms a polymer laminate consisting of a portion of the first polymer coupon and a portion of the additional layer of polymer that includes a slot to which at least one component able to provide a therapeutic benefit or perform a diagnostic function is attached;

after said step of separating the first polymer coupon into the at least two sections, dissolving the adhesive layer between the first polymer coupon and the first rigid backing; and

after said step of dissolving the adhesive layer, lifting off the polymer laminates to which the components are attached and that include the slots from the first rigid backing, the lifted off polymer laminates and the attached components forming plural medical devices.

18. The method of assembling medical devices of claim 17, wherein:

in addition to said step of forming slots in the first polymer coupon, forming voids in the first polymer coupon, the voids being separate from the slots, and formed to extend only partially through the first polymer coupon and being located in the first polymer coupon so as to be within the sections of the first polymer coupon that will form the polymer laminates; and

in said step of attaching components to the first polymer coupon, components are disposed in the voids located in the sections of the polymer coupon that will form the medical devices.

19. The method of assembling medical devices of claim 17, wherein during said first polymer coupon bonding step, said sub-step of applying a force against the first polymer coupon is initiated prior to initiating said step of drawing the suction on the first polymer coupon and the first rigid backing.

20. The method of assembling medical devices of claim 17, wherein said step of separating the first polymer coupon into separate sections is performed after said step of affixing components to the first polymer coupon.

21. The method of assembling medical devices of claim 17, wherein said step of forming slots in the first polymer coupon is performed prior to said step of affixing components to the first polymer coupon.

22. The method of assembling medical devices of claim 17, wherein, after said step of drawing a suction of the first polymer coupon and the first rigid backing is terminated so that the first coupon and the first rigid backing return to an ambient pressure, said step of applying a force to the first polymer coupon is terminated.

23. The method of assembling medical devices of claim 17, wherein said step of separating the first polymer coupon into plural sections is performed by cutting the coupon or etching away portions of the coupon to define the separate sections of the coupon.

24. The method of assembling medical devices of claim 17, wherein:

while said first polymer coupon remains attached to the first rigid coupon, attaching at least one stiffening member that increases the rigidity of the polymer to the first polymer coupon; and

in said step of shaping the first polymer coupon, shaping the first polymer coupon so the at least one stiffening member is part of one of the polymer laminates that becomes medical device.

25. The method of assembling medical devices of claim 17, wherein in said step of affixing components to the first polymer coupon, components are attached to the coupon so that the lifted off polymer laminates and attached components form plural implantable electrode arrays.

26. The method of assembling medical devices of claim 17, wherein the first polymer coupon is a liquid crystal polymer.

27. The method of assembling medical devices of claim 17, wherein the first polymer coupon has a maximum thickness of 1 mm.

28. The method of assembling medical devices of claim 17, wherein, said step of shaping the first polymer coupon into at least two sections and said step of shaping the additional layer of polymer disposed over the at least two sections of the first polymer coupon are performed as single step.

29. The method of assembling plural medical devices of claim 17, where said step of bonding an additional layer of polymer to the first polymer coupon is performed by:

bonding a second polymer coupon to a second rigid backing;

bonding the second polymer coupon to the first polymer coupon so that, in said step of bonding the second polymer coupon to the first polymer coupon, an exposed face of the second polymer coupon opposite the second rigid backing is bonded to the exposed face of the first polymer coupon; and

after said step of bonding the second polymer coupon to the first polymer coupon, the second rigid backing is removed from the second polymer coupon.

30. The method of assembling plural medical devices of claim 17, wherein:

prior to said step of bonding the additional layer of polymer over the first polymer coupon, at least one stiffening member that increases the rigidity of the polymer is attached to the first polymer coupon;

after said step of attaching the at least one stiffening member to the first polymer coupon, said step of bonding the additional layer of polymer of the first polymer coupon is performed so the additional layer of polymer is disposed over the at least one stiffening member; and

said step of separating the first polymer coupon and said step of shaping the additional polymer layer of polymer are performed so that the at least one stiffening member is contained in one of the polymer laminates that form a medical device.

31. The method of assembling plural medical devices of claim 17, wherein said step of shaping the additional layer of polymer disposed over the at least two sections of the first polymer coupon is performed prior to said step of bonding the additional layer of polymer to the first polymer coupon.

32. The method of assembling plural medical devices of claim 17, wherein, prior to said step of bonding the additional layer of polymer over the exposed face of the first polymer coupon, the slots are formed in the additional layer of polymer.

33. The method of assembling plural medical devices of claim 17, wherein in said step of forming slots in the first polymer coupon the slots are positioned and the slots formed in the additional polymer layer are positioned so that at least one of the slots in the polymer laminates that form the medical devices is located inwardly of an outer perimeter of the polymer laminate that includes the slot.