Medical device having bonding regions and method of making the same

• US 8,133,346 B2
• Filed: 09/30/2008
• Issued: 03/13/2012
• Est. Priority Date: 09/30/2008
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Huang, I Mark, Williamson, Michael V.
• Primary Examiner(s): Nguyen, Khanh P
• Assistant Examiner(s): Patel, Vishal I
• Application Number:
  US12/242,088
• Publication Number:
  US 20100078123A1
• Time in Patent Office: 1,260 Days
• Field of Search: 156/89.15, 156/89.16, 156/320, 156/321, 156/322, 156/325, 156/244.11, 156/242
• US Class Current: 156/325
• CPC Class Codes: B32B 9/04 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material next to a glass layer B32B17/06; layered products with at least two ceramic layers composed mainly of ceramic B32B18/00
• CPC Class Codes: C04B 37/00 Joining burned ceramic articles with other burned ceramic articles or other articles by heating soldering and welding materials B23K35/24; laminated products B32B, E04C
• CPC Class Codes: C09J 2400/166 in the pretreated surface to be joined
• CPC Class Codes: C09J 5/02 involving pretreatment of the surfaces to be joined
• CPC Class Codes: C09J 5/06 involving heating of the applied adhesive
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 428/12979 Containing more than 10% nonferrous elements [e.g., high alloy, stainless]
• CPC Class Codes: Y10T 428/31504 Composite [nonstructural laminate]
• CPC Class Codes: Y10T 428/31544 Addition polymer is perhalogenated
• CPC Class Codes: Y10T 428/31678 Of metal

Abstract

Medical devices comprised of bonded joints are disclosed. The bonded joints comprise two surfaces bonded by a layer of phenoxy resin therebetween. In the preferred embodiments, bonded surfaces are comprised of materials that are suitable for medical devices. Most preferably, Nitinol comprises at least one bonded surface, however, other preferred materials may include, but are not limited to cobalt chromium, stainless steel, titanium, tantalum, and plastic. An intraluminal device comprised of a plurality of locations with a phenoxy resin layer is also disclosed wherein the phenoxy resin is further comprised of a radiopaque additive, a lubricious additive, or both radiopaque and lubricious additives. Also disclosed is an intraluminal device comprised of contiguous heterogeneous structural elements comprised of metallic members and non-metallic sections that are bonded together by a layer of phenoxy resin therebetween.

Claims

1. A method for fabricating a medical device, the method comprising the steps of:

providing a first member, the first member having a first surface with an available surface oxygen;

providing a second member, the second member having a second surface with an available surface oxygen;

providing a bonding agent having a plurality of secondary hydroxyl functional groups with an affinity to form hydrogen bonds with the oxygen present on the surface of the first and the second member; and

indirectly affixing the first member and the second member with the bonding agent by heating at least one of the first member, the second member or the bonding agent until (i) forming a covalent bond between the available surface oxygen on the first surface and at least one of the hydroxyl functional groups of the bonding agent, and (ii) forming a covalent bond between the available surface oxygen on the second surface and at least one of the hydroxyl functional groups of the bonding agent.

2. The method of claim 1 wherein at least one of the first surface or the second surface have an oxide surface.

3. The method of claim 2 wherein the oxide surface is a passivated oxide surface.

4. The method of claim 1 wherein at least one of the first member or the second member comprises a nickel titanium alloy.

5. The method of claim 1 wherein at least one of the first member or the second member comprises Chromium oxide.

6. The method of claim 1 wherein at least one of the first member or the second member comprises Titanium oxide.

7. The method of claim 1 wherein at least one of the first member or the second member is an inert material having available surface oxygen.

8. The method of claim 7 wherein the inert material is polytetrafluoroethylene.

9. The method of claim 1 wherein the bonding agent is a polyhydroxyl ether.

10. The method of claim 9 wherein the polyhydroxyl ether is a phenoxy resin.

11. The method of claim 1 further comprising cross linking at least one of the first member, the second member or the bonding agent until the covalent bond is created between at least one of the first member or the second member and the bonding agent.

12. The method of claim 1 wherein the bonding agent has a high glass transition temperature.

13. The method of claim 12 wherein the glass transition temperature is between about 70 degrees Celsius and 100 degrees Celsius.

14. The method of claim 1 further comprising sterilizing the medical device after affixing the first member and the second member.

15. The method of claim 14 wherein sterilizing the medical device comprises heating an ethylene oxide gas.

16. The method of claim 14 wherein the ethylene oxide gas is heated to a temperature of about 60 degrees Celsius.

17. The method of claim 14 wherein sterilizing the medical device includes heating the medical device in an autoclave employing superheated steam.

18. The method of claim 14 wherein sterilizing the medical device includes bombarding the medical device with an electron beam.

19. The method of claim 14 wherein sterilizing the medical devices includes bombarding the medical device with gamma radiation.

20. The method of claim 1 wherein causing the bonding agent to contact the first surface and the second surface comprises spray coating the bonding agent on at least one of the first surface or the second surface.

21. The method of claim 1 wherein causing the bonding agent to contact the first surface and the second surface comprises powder coating the bonding agent on at least one of the first surface or the second surface.

22. The method of claim 1 wherein causing the bonding agent to contact the first surface and the second surface comprises fluidized bed coating the bonding agent on at least one of the first surface or the second surface.

23. The method of claim 1 wherein causing the bonding agent to contact the first surface and the second surface comprises solution dipping coating the bonding agent on at least one of the first surface or the second surface.

24. The method of claim 1 further comprising pre-forming the bonding agent by extrusion.

25. The method of claim 1 further comprising pre-forming the bonding agent by molding.

26. A method for fabricating a medical device, the method comprising the steps of:

providing a first member, the first member having a first surface with an available surface oxygen;

providing a second member, the second member having a second surface with an available surface oxygen;

providing a bonding agent having a plurality of secondary hydroxyl functional groups with an affinity to form hydrogen bonds with the oxygen present on the surface of the first and the second member; and

affixing the first member and the second member by heating at least one of the first member, the second member or the bonding agent to create a hydrogen bond between the (i) the available surface oxygen on the first surface and at least one of the hydroxyl functional groups of the bonding agent and (ii) the available surface oxygen on the second surface and at least one of the hydroxyl functional groups of the bonding agent.