Frames for implantable medical devices and methods
Frame structures, assemblies and methods for use in implantable medical devices. The frames may include one or more first polymeric portions and one or more second polymeric portions coupled to the one or more first polymeric portions. The one or more first polymeric portions may have a higher durometer than the one or more second polymeric portions. The one or more second polymeric portions may provide an interference fit between the one or more second polymeric portions and the housing and/or between the one or more second polymeric portions and one or more components disposed in the housing.
1. An implantable medical device comprising:
a housing defining an interior space;
one or more components disposed in the interior space of the housing;
a frame disposed in the interior space of the housing, wherein the frame comprises:
one or more first polymeric portions; and
one or more second polymeric portions coupled to the one or more first polymeric portions;
wherein at least one of the one or more first polymeric portions has a higher durometer than at least one of the one or more second polymeric portions; and
wherein the one or more second polymeric portions provides an interference fit between the one or more second polymeric portions and at least one of the housing and the one or more components disposed in the interior space of the housing.
2. The device of claim 1 , wherein at least one of the one or more second polymeric portions comprise a thermoplastic elastomer.
3. The device of claim 1 , wherein the one or more second polymeric portions comprises a material having a durometer less than or equal to 55D.
4. The device of claim 1 , wherein the one or more second polymeric portions are resilient such that the one or more second polymeric portions are compressible under application of force from an uncompressed state to a compressed state.
5. The device of claim 4 , wherein the one or more first polymeric portions defines an outer surface, and wherein the one or more second polymeric portions define a contact surface configured to contact at least one of the one or more components or the housing, wherein the contact surface is located away from the outer surface of the first polymeric portion, wherein the contact surface of the second polymeric portion is located closer to the outer surface of the one or more first polymeric portions when in the compressed state than when in the uncompressed state.
6. The device of claim 5 , wherein the housing applies a compressive force to the one or more second polymeric portions to provide the interference fit between the one or more second polymeric portions and at least one of the housing and the one or more components.
7. The device of claim 1 , wherein the one or more first polymeric portions defines a first surface, a second surface opposite the first surface, and one or more openings extending through the one or more first polymeric portions from the first surface to the second surface, wherein at least a portion of at least one of the one or more components is located within at least one of the one or more openings.
8. The device of claim 1 , wherein the one or more first polymeric portion defines a first surface, a second surface opposite the first surface, and one or more apertures extending from the first surface to the second surface, and wherein at least a portion of at least one of the one or more second polymeric portions is located within at least one of the one or more apertures.
9. The device of claim 1 , wherein the one or more first polymeric portions defines an outer perimeter, and wherein at least a portion of the one or more second polymeric portions is coupled to the first polymeric portion proximate the outer perimeter.
10. The device of claim 1 , wherein the one or more first polymeric portions defines an outer perimeter, and wherein at least one of the one or more second polymeric portions is not exposed to the outer perimeter.
11. The device of claim 1 , wherein at least one of the one or more first polymeric portions and/or at least one of the one or more second polymeric portions further comprise a desiccant.
12. The device of claim 11 , wherein the one or more second polymeric portions comprise a polymer including a desiccant material, wherein the second polymeric portions are configured to absorb 0.1-300 milligrams of moisture per gram of the polymer including the desiccant material at 0.1-300 hours exposure to 0-70% relative humidity.
13. The device of claim 12 , wherein the one or more second polymeric portions comprise a polymer including a desiccant material, wherein the second polymeric portions are configured to absorb 50-120 milligrams of moisture per gram of the polymer including the desiccant material at 200 hours exposure to 20-50% relative humidity.
14. The device of claim 1 , wherein at least one of the one or more first polymeric portions and/or the one or more second polymeric portions further comprise a sorbent.
15. The device of claim 14 , wherein the sorbent comprises activated carbon.
16. The device of claim 14 , wherein the sorbent comprises a hydrogen gas sorbent.
17. The device of claim 1 , wherein the one or more second polymeric portions comprise an SEBS thermoplastic elastomer mixed with a molecular sieve powder desiccant.
18. The device of claim 1 , wherein the one or more second polymeric portions comprise an EPDM/PP thermoplastic elastomer blend mixed with a molecular sieve powder desiccant.
19. The device of claim 1 , wherein the one or more second polymeric portions comprise thermoplastic polyether-polyurethane copolymer elastomer mixed with a molecular sieve powder desiccant.
20. The device of claim 1 , wherein the one or more second polymeric portions comprise a crystalline polyethylene (PE) polymer mixed with a molecular sieve powder desiccant.
21. The device of claim 1 , wherein the one or more first polymeric portions have a durometer greater than or equal to 90D, and the one or more second polymeric portions have a durometer less than or equal to 90A on the Shore Durometer Scale.
22. The device of claim 1 , wherein the one or more first polymeric portions have a durometer greater than or equal to 100 on Rockwell R scale, and the one or more second polymeric portions have a durometer less than or equal to 80A on Shore Durometer scale.
23. A method of manufacturing an implantable medical device, wherein the method comprises:
providing a housing defining an interior space;
providing one or more components;
providing one or more first polymeric portions;
coupling one or more second polymeric portions to the one or more first polymeric portions to form a frame, wherein at least one of the one or more first polymeric portions has a higher durometer than at least one of the one or more second polymeric portions;
inserting the one or more components and the frame into the interior space of the housing; and
closing the housing, providing an interference fit between the one or more second polymeric portions and at least one of the housing and the one or more components.
24. The method of claim 23 , wherein at least one of the one or more first polymeric portions and the one or more second polymeric portions further comprise a desiccant material.
25. The method of claim 23 , wherein providing the one or more first polymeric portions comprises:
providing a first mold defining a first cavity for forming the one or more first polymeric portions;
introducing a first moldable material into the first cavity of the first mold to form the one or more first polymeric portions; and
forming the one or more first polymeric portions from the first moldable material within the first cavity of the mold.
26. The method of claim 23 , wherein providing the one or more first polymeric portions comprises:
providing a first mold defining a first cavity for forming the one or more first polymeric portions;
introducing a first moldable material into the first cavity of the first mold to form the one or more first polymeric portions; and
forming the one or more first polymeric portions from the first moldable material within the first cavity; and
wherein coupling the one or more second polymeric portions to the one or more first polymeric portions comprises:
providing a second mold defining a second cavity for forming a second polymeric portion;
positioning the one or more first polymeric portions into the second cavity; and
introducing a second moldable material into the second cavity of the second mold to form the one or more second polymeric portions and to couple the one or more second polymeric portions to the one or more first polymeric portions.
27. The method of claim 26 , wherein the second mold comprises at least a portion of the first mold.