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

Patent metadata

Field	Value
Publication number	US-2017367652-A1
Application number	US-201715643656-A
Country	US
Kind code	A1
Filing date	Jul 7, 2017
Priority date	May 17, 2011
Publication date	Dec 28, 2017
Grant date	—

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.

First claim

What is claimed is:

1 . A method of assembling a medical device 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 rigid backing;
placing the polymer coupon on the adhesive layer; and
applying pressure to the polymer coupon to cause the coupon to bond to the adhesive layer wherein, as a result of said bonding step, the first polymer coupon has an exposed face that is opposite the first rigid backing;
attaching a component to a the exposed face of a section of the coupon, the component able to provide a therapeutic benefit and/or offer diagnostic information; while the first flexible polymer coupon remains attached to the first rigid backing, selectively shaping the coupon so that the section of the coupon to which the therapeutic or diagnostic component is attached is smaller is area than the whole of the coupon; and 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 section of the first polymer coupon to which the therapeutic or diagnostic component is attached from the first rigid backing, the lifted off section of the first polymer coupon forming the medical device.

2 . The method of assembling a medical device for implantation of any one of claim 1 , wherein:
in said step of attaching the therapeutic or diagnostic component to the first polymer coupon, plural therapeutic or diagnostic components are attached to the coupon so as to be spaced apart from each other; in said step of selectively shaping the first polymer coupon the coupon is shaped to form plural sections, each section having at least one of the therapeutic or diagnostic components mounted to the section; and in said adhesive dissolving step, dissolving the adhesive between the plural sections of the polymer coupon and the first rigid backing so that, in said lift off step, the plural polymer sections with attached therapeutic or diagnostic component are lifted off from the first rigid backing.

3 . The method of assembling a medical device for implantation of claim 1 , wherein:
after the first polymer coupon is bonded to the first backing, forming an opening that extends inwardly from the exposed surface of the first polymer coupon; and in said step of attaching the component to the coupon, the component is at least partially seated in the opening formed in the coupon.

4 . The method of assembling a medical device for implantation of claim 3 , wherein, in said step of forming the opening in the first polymer coupon, forming the opening so that the opening does not extend completely through the coupon.

5 . The method of assembling a medical device for implantation of claim 1 , further including the steps of:
bonding a second flexible polymer coupon ( 196 ) to a second rigid backing using said bonding step used to bond the first flexible polymer coupon to the first rigid backing wherein, as a result of said bonding step, the second polymer coupon has an exposed face opposite the second rigid backing; bonding the exposed faces of the first and second polymer coupons together to form a multilayer structure; and dissolving the adhesive layer between the second flexible polymer coupon and the second rigid backing to remove the second rigid backing from the second polymer coupon.

6 . The method of assembling a medical device for implantation of claim 5 , wherein:
after said step of dissolving the adhesive layer between the second flexible polymer coupon and the second rigid backing, selectively shaping the multilayer structure; and after shaping the multilayer structure, performing said step of dissolving the adhesive layer between the first flexible polymer layer and the first rigid backing.

7 . The method of assembling a medical device for implantation of claim 1 , further including the steps of:
prior to said step of dissolving the adhesive layer between first polymer coupon and the first rigid backing, mounting a stiffening component to the first polymer coupon; and in said step of shaping the first polymer coupon, shaping the coupon so that the section of the coupon to which the therapeutic or diagnostic component is attached includes the stiffening component.

8 . The method of assembling a medical device for implantation of claim 7 , wherein the stiffening component is elastic.

9 . The method of assembling a medical device for implantation of claim 1 , wherein said step of selectively shaping the first coupon is performed after said step of attaching the therapeutic or diagnostic device to the first coupon.

10 . The method of assembling a medical device for implantation of claim 1 , wherein said step of selectively shaping the first coupon is performed by selectively cutting the coupon.

11 . The method of assembling a medical device for implantation of claim 1 , wherein said step of selectively shaping the first coupon is performed by etching away sections of the coupon to define the section of the coupon with the attached therapeutic or diagnostic component.

12 . The method of assembling a medical device for implantation of claim 1 , wherein in, said step of apply adhesive to the first rigid backing the adhesive is a applied so the variation in thickness of the adhesive layer is adhesive has a maximum thickness of 5 microns and variation in thickness of less than 1%.

13 . The method of assembling a medical device for implantation of claim 1 , wherein during said step of applying pressure to the first polymer coupon to bond the coupon to the adhesive layer, the pressure while the coupon and the first rigid backing are in a chamber in which a suction is drawn.

14 . The method of assembling a medical device for implantation of claim 1 , wherein the first polymer coupon has a maximum thickness of 1 mm.

15 . The method of assembling a medical device for implantation of claim 1 , wherein the first polymer coupon is from one of the group consisting of: liquid crystal polymer; silicone; parylene; polyamide; and composite structures that include at least one polymer.

16 . The method of assembling a medical device for implantation of claim 1 , wherein the assembled device includes plural electrodes.

17 . A method of assembling a medical device 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 rigid backing;
placing the polymer coupon on the adhesive layer; and
applying pressure to the polymer coupon to cause the coupon to bond to the adhesive layer wherein, as a result of said bonding step, the first polymer coupon has an exposed face that is opposite the first rigid backing;
bonding a second flexible polymer coupon formed from biocompatible material to a second rigid backing using said bonding step used to bond the first flexible polymer coupon to the first rigid backing wherein, as a result of said bonding step, the second polymer coupon has an exposed face opposite the second rigid backing; attaching a component to the exposed face of at least one of the polymer coupons, the component able to provide a therapeutic benefit and/or offer diagnostic information; bonding the exposed faces of the first an

Assignees

• Stryker Corp

Inventors

• Janik John
• Brindley Robert
• Tang Edward Chia-Ning

Classifications

• H10W70/614

  the multiple chips being integrally enclosed · CPC title

• H10W70/09 Primary

  extending onto an encapsulation that laterally surrounds the chip or wafer, e.g. fan-out wafer level package [FOWLP] RDLs · CPC title

• A61N1/05

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title

• A61N1/0553

  Paddle shaped electrodes, e.g. for laminotomy · CPC title

• A61B5/05

  Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (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 title