Patterned implant and method

• US 9,060,836 B2
• Filed: 11/23/2010
• Issued: 06/23/2015
• Est. Priority Date: 11/23/2009
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Jagger, Karl A., Hacker, Dean W., Felton, Jessica E., Frigstad, John R., Peterson, Alex A.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): DORNA, CARRIE R
• Application Number:
  US12/953,268
• Publication Number:
  US 20110144417A1
• Time in Patent Office: 1,673 Days
• Field of Search: 600 29- 32, 600/37, 606/151, 606/157, 606/153
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0023 differing in porosity

Abstract

A unitary or homogeneous patterned implant is provided. The implant is constructed of patterned cells formed by way of a molding, die casting, laser etching, laser cutting, extruding, and the like. Portions of the implant can be formed into sinusoid or other waveform strut members to control and promote elongation, expansion or contraction along single or multiple axes. As such, controlled and designated stress, tension and compression distribution is promoted across specific or localized areas of the implant.

Claims

1. A unitary patterned implant device for treating vaginal prolapse in a patient, comprising:

a non-woven unitary support portion including a plurality of undulating strut members joined at and spanning out from a plurality of fixed junctions to define a plurality of substantially identical repeating cells having voids, the support portion having first and second opposing eyelets;

first and second opposing anchor portions provided a distance from the first and second opposing eyelets, with each of the first and second opposing anchor portions further including a cylindrical rod extending out from the anchor portions and a tissue anchor provided at a distal end of the cylindrical rod of each of the first and second opposing anchor portions, the tissue anchor having one or more angled tines and an anchor length;

at least one transition zone integrally formed with the support portion and the first anchor portion, defining a plurality of generally elongate non-woven cells of a different shape and larger than the substantially identical repeating cells of the support portion, and spanning between the support portion and the first anchor portion such that the at least one transition zone tapers and narrows from the support portion to the first anchor portion; and

an anchoring arm having a distal tissue anchor and an extending rod member adapted to slidably engage and secure with one of the first and second eyelets of the support portion.

2. The implant device of claim 1, further including a grommet having a plurality of extending teeth, the grommet integrally formed with at least one of the first and second opposing eyelets.

3. The implant device of claim 1, further including a central axis line defined in the plurality of undulating strut members.

4. The implant device of claim 1, further including a removable posterior tail portion.

5. The implant device of claim 4, wherein the removable posterior tail portion includes a crush line along a portion of the undulating strut members.

6. The implant device of claim 1, further including stretch sinusoid elements with a plurality of the plurality of undulating strut members to provide selective stretching of a portion of the support portion.

7. The implant device of claim 6, wherein the stretch sinusoid elements includes at least one low frequency sinusoid element and at least one high frequency sinusoid element.

8. The implant device of claim 1, further including a plurality of nubs disposed and extending within a plurality of the voids.

9. The implant device of claim 1, further including a second transition zone spanning between the non-woven unitary support portion and the second anchor portion.

10. The implant device of claim 1, wherein a plurality of the repeating cells display a Negative Poisson ratio during a load application.

11. A unitary implant system for treating vaginal prolapse in a patient, comprising:

a non-woven unitary support portion including a plurality of undulating strut members joined at and spanning out from a plurality of fixed junctions to define a plurality of substantially identical repeating cells having voids, the support portion having first and second opposing eyelets and first and second opposing anchor portions provided a distance from the first and second opposing eyelets and extending out from the support portion with each of the first and second opposing anchor portions further including an end anchor and a cylindrical anchor rod;

a transition zone integrally formed with the support portion and the first anchor portion, defining a plurality of generally elongate non-woven cells of a different shape and larger than the substantially identical repeating cells of the support portion, and spanning between the support portion and the first anchor portion such that the transition zone tapers and narrows from the support portion to the first anchor portion;

an insertion tool having a handle, a needle and a distal tip; and

an anchoring arm having a distal tissue anchor and an extending rod member, wherein the distal tissue anchor is adapted to releasably engage with the distal tip of the insertion tool and the extending rod member is adapted to slidably engage and secure with one of the first and second eyelets of the support portion.

12. The system of claim 11, further including a grommet having a plurality of extending teeth, the grommet integrally formed with at least one of the first and second opposing eyelets.

13. The system of claim 12, wherein the anchoring arm further includes a mesh element securable within the plurality of extending teeth of the grommet.

14. The system of claim 11, wherein the support portion further includes a removable posterior tail portion.

15. The system of claim 14, wherein the removable posterior tail portion includes a crush line along a portion of the undulating strut members.

16. The system of claim 11, wherein the support portion further includes stretch sinusoid elements with a plurality of the plurality of undulating strut members to provide selective stretching of a portion of the support portion.

17. The system of claim 11, further including a plurality of nubs disposed and extending within a plurality of the voids.

18. The system of claim 11, wherein a plurality of the repeating cells display a Negative Poisson ratio during a load application.

19. The system of claim 11, wherein the insertion tool further includes an actuation mechanism in operative communication with the distal tip and adapted to releasably engage the distal tissue anchor from the distal tip.

20. The system of claim 11, wherein the unitary support portion is formed from a polymer molding process.