Pelvic implant and treatment method

• US 9,974,640 B2
• Filed: 09/24/2012
• Issued: 05/22/2018
• Est. Priority Date: 09/22/2011
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hacker, Dean W., Jagger, Karl A., Wilke, Benjamin M., Kelto, Seth C., Felton, Jessica E.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US14/346,383
• Publication Number:
  US 20140257032A1
• Time in Patent Office: 2,066 Days
• Field of Search: 600 29- 32, 600 37, 606151, 606153
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 5/107 Measuring physical dimensions, e.g. size of the entire body or parts thereof
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2240/004 Using a positive or negative model, e.g. moulds
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

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. One or more undulating anchor arms or rods extend out from the implant for tissue fixation, with the one or more undulating anchor arms including one or more arcuate bends.

Claims

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

a 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 repeating cells having voids, the support portion having a first eyelet, and a second eyelet;

an undulating rod member operatively extending out from the support portion, the undulating rod member including a first curved section and a second curved section, the second curved section curving in a direction opposite to the first curved section, the second curved section having a radius larger than a radius of the first curved section; and

a tissue anchor coupled to a distal end of the undulating rod member, the tissue anchor having one or more tines configured to engage soft tissue of the patient.

2. The implant device of claim 1, further including at least one 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, wherein the distal tissue anchor of the at least one anchoring arm is adapted for fixation to the sacrospinous ligament of the patient.

3. 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 eyelets.

4. The implant device of claim 1, wherein the tissue anchor is rotatably coupled to the distal end of the undulating rod member.

5. The implant device of claim 1, further including at least one transition zone extending out from the support portion to a proximal end of the undulating rod member.

6. The implant device of claim 1, wherein the undulating rod member includes a third curved section.

7. The implant device of claim 1, wherein the second curved section has a length larger than a length of the first curved section.

8. 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 repeating cells having voids, the support portion having first and second opposing anchoring portions operatively extending out from the support portion; and

first and second opposing undulating rod members operatively extending out from the respective first and second opposing anchoring portions, the first undulating rod member including a first curved section, and a second curved section, the second curved section having a length larger than a length of the first curved section,

a first tissue anchor coupled to a distal end of the first undulating rod member; and

a second tissue anchor coupled to a distal end of the second undulating rod member.

9. The system of claim 8, further including first and second eyelet portions.

10. The system of claim 9, further including first and second grommets provided with the respective first and second eyelet portions, the first and second grommets having a plurality of extending teeth.

11. The system of claim 10, wherein the first and second grommets are integrally formed with the first and second eyelets.

12. The system of claim 8, wherein the first and second undulating rod members are polymer rod members.

13. The system of claim 8, further including at least one transition zone extending out from the support portion to at least one of the first and second opposing undulating rod members.

14. The system of claim 8, wherein the first undulating rod member includes a third curved section, the first curved section defining a first C-shape, the second curved section defining a second C-shape, and the third curved section defining a third C-shape.

15. The system of claim 8, wherein the second curved section has a radius larger than a radius of the first curved section.

16. The system of claim 8, wherein the non-woven unitary support portion is formed from a polymer molding process.

17. The system of claim 8, wherein portions of the outer periphery of the unitary support portion includes rounded struts to assist in reducing tissue snagging.

25. The implant device of claim 8, wherein at least the support portion is formed from a polymer molding process.

18. An implant device for supporting tissue of a patient, comprising:

a support portion adapted to support pelvic tissue within the patient; and

first and second opposing anchor portions, the first anchor portion including an undulating rod member operatively extending out from the support portion, the undulating rod member including a first curved portion and a second curved section, the second curved section curving in a direction opposite to the first curved section, the second curved section having a length larger than a length of the first curved section, the second curved section having a radius larger than a radius of the first curved section; and

a tissue anchor coupled to a distal end of the undulating rod member, the tissue anchor having one or more tines configured to engage with soft tissue of the patient.

19. The implant device of claim 18, further including first and second eyelet portions.

20. The implant device of claim 19, further including first and second grommets provided with the respective first and second eyelet portions, the first and second grommets having a plurality of extending teeth.

21. The implant device of claim 20, wherein the first and second grommets are integrally formed with the respective first and second eyelets.

22. The implant device of claim 18, wherein the support portion is constructed as a molded 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 repeating cells having voids.

23. The implant device of claim 18, further including at least one transition zone extending out from the support portion to at least one of the first and second opposing undulating rod members.

24. The implant device of claim 18, wherein the undulating rod member includes a third curved section.