Surgical implants and related methods and systems

• US 7,722,528 B2
• Filed: 02/03/2006
• Issued: 05/25/2010
• Est. Priority Date: 02/04/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Hauschild, Sidney F., Arnal, Kevin R., Roychowdhury, Suranjan, Lund, Robert E., Vancelette, David W.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/347,596
• Publication Number:
  US 20060195010A1
• Time in Patent Office: 1,572 Days
• Field of Search: 128897-898, 128/885, 600 29- 30, 600/37, 606/72, 606/119, 606/139, 606151-156, 606/198, 623/13.11, 623/13.2
• US Class Current: 600/30
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• 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 2250/0078 Gender-specific, e.g. different for male and female patients
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

Described are surgical implants, tools, systems, and related methods, useful for implantation of surgical implants, such as those used to treat pelvic conditions including but not limited to incontinence; an implant may features such as a stiffened non-flat form; a suture running; a system may include a surgical implant as described and an installation tool; methods may include a method of preparing a surgical implant and a method of implanting a urethral sling.

Claims

1. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions selected from the group consisting of a barb, a tine, a fiber, a strand, a filament, and combinations thereof.

2. The implant of claim 1, wherein each layer comprises a major surface and side edge, wherein the layers are substantially aligned along lengths of the end portions, and one layer is attached to a major surface of another layer.

3. The implant of claim 1, wherein layers are attached by a fastening mechanism selected from the group consisting of adhesive, suture, staple, thermoforming, and combinations thereof.

4. A method of preparing a surgical implant according to claim 1, the method comprising:

providing at least two open pore elongate strips comprising major surfaces and edges;

contacting a major surface of one strip, to the other strip,

attaching the strips.

5. A surgical system comprising, in combination,

a urethral sling according to claim 1, and

an installation tool comprising a handle and a curved portion, the curved portion being curved in three-dimensions.

6. The implant of claim 1, wherein one or more of the multiple layers of the end portion comprises a mesh.

7. The implant of claim 1 wherein the two layers of the end portion comprise a mesh.

8. The implant of claim 1 wherein each layer comprises a porous material selected from the group consisting of:

a porous film, a porous braided material, a porous knit material, a porous tied material, a porous mesh material, a porous woven material, a porous non-woven material, a porous fabric-type material, and combinations thereof.

9. A method of preparing a surgical implant comprising a central support portion and two elongate end portions attached to the central support portion, the central support portion comprising a stiffened non-flat curved form conforming to pelvic tissue selected from tissue selected from the group consisting of a bladder, urethra, vagina, corpus spongiosum, and bulbous cavernosum muscle, the method comprising:

providing an open pore elongate material in the form of a portion of an implant;

treating the central support portion to produce a central support portion having a stiffened non-flat curved form of a shape adapted to align with a tissue selected from the group consisting of a bladder, urethra, vagina, corpus spongiosum, and bulbous cavernosum muscle;

wherein the central support portion is treated by a method selected from the group consisting of;

heat treatment, thermoforming, coating with a stiffening material, and a combination thereof.

10. A method of claim 9 wherein the implant comprises a non-flat stiffened end portion comprising a form selected from a longitudinal wave, a lateral curl, a longitudinal curl, a bend, and a longitudinal twist.

11. A method of claim 9 wherein the central support portion is treated using a stiffening coating comprising polymer selected from the group consisting of mannitol, dextrose, sorbose, sucrose, a salt, sodium chloride, potassium chloride, sodium carbonate, polyvinylpyrrolidone, and combinations thereof.

12. A surgical system comprising, in combination,

a urethral sling comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion comprising a stiffened non-flat curved form conforming to pelvic tissue selected from the group consisting of a bladder, urethra, vagina, corpus spongiosum, and bulbous cavernosum muscle, wherein the central support portion is treated to achieve the non-flat form, by treatment selected from the group consisting of:

heat treatment, thermoforming, coating with a stiffening material, and a combination thereof, and

an installation tool comprising a handle and a curved portion, the curved portion being curved in three-dimensions.

13. A method of implanting a urethral sling in a male, the method comprising

providing a sling comprising a support portion and an elongate end portion attached to the support portion, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension,

providing a biological adhesive,

installing the sling to contact pelvic tissue of a male using a transobturator tissue path, including

creating a medial incision at the external male perineum,

inserting the sling through the medial incision to place the support portion at a location to support the urethra,

contacting the end portion with biological adhesive, and

placing the end portion through a tissue path extending between the location to support the urethra, and an obturator foramen, to secure the sling internally.

14. A surgical implant comprising an elongate end portion, the elongate end portion comprising a suture running along a length of the end portion, the suture being attached at more than two attachment points.

15. The implant of claim 14, wherein the suture is attached at intervals in the range from 0.5 to 5 centimeters.

16. The implant of claim 14, wherein the implant comprises 2 sutures, each extending along a length of the implant and each attached at intervals in the range from 0.5 to 5 centimeters.

17. The implant of claim 14 wherein the end portion comprises two sutures running along a length of the end portion, each suture being attached at more than two attachment points.

18. The implant of claim 14 wherein the implant comprises two elongate end portions each end portion extending from the central support portion, and wherein the central support portion has a width greater than the width of the elongate end portions.

19. The implant of claim 18 wherein the implant comprises a sheath along each elongate end portion.

20. The implant of claim 18 comprising reinforced edge extensions.

21. A kit comprising an implant of claim 14 in combination with an insertion tool, the insertion tool comprising a handle and a helical needle, the handle comprising a non-circular cross-section and a midplane.

22. A kit according to claim 21

wherein the implant comprises two elongate end portions, each extending from the central support portion,

wherein the central support portion has a width greater than a width of the elongate end portions,

wherein the implant comprises a plastic sheath along each elongate end portion, and

wherein each sheath comprises a connector at an end of the sheath, the connector being capable of engaging a distal end of the helical needle.

23. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions, wherein each layer comprises a major surface, wherein the layers are substantially offset along the lengths of the end portions, and one layer is attached to a major surface of another layer.

24. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions, wherein a first layer of open pore elongate strip is twisted relative to a second layer of open pore elongate strip having first and second major surfaces and attached to a first major surface of the second layer.

25. The implant of claim 24, wherein a third layer of open pore elongate strip is twisted relative to the second layer and attached to the second major surface of the second layer.

26. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions, wherein a first layer and a second layer of open pore elongate strip are twisted and attached to each other.

27. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions, wherein one or more of the multiple layers of the end portion comprises a mesh, and wherein one or more of the multiple layers of the end portion comprises a twist, bend, curve or wave.

28. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions, wherein the two layers of the end portion comprise a mesh.

29. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions selected from the group consisting of a barb, a tine, a fiber, a strand, a filament, and combinations thereof, wherein each layer comprises a major surface, wherein the layers are substantially offset along the lengths of the end portions, and one layer is attached to a major surface of another layer.

30. A surgical implant comprising a central support portion and an elongate end portion attached to the central support portion, the central support portion being configured to support pelvic tissue, the elongate end portion having a length dimension extending away from the central support portion, and a width dimension, the length dimension being greater than the width dimension, the elongate end portion extending from the central support portion and configured to extend to pelvic tissue to support the central support portion, the end portion comprising multiple layers of open pore elongate strip, wherein two edges of two layers comprise edge extensions, and wherein each layer comprises a porous material selected from the group consisting of:

a porous film, a porous braided material, a porous knit material, a porous tied material, a porous mesh material, a porous woven material, a porous non-woven material, a porous fabric-type material, and combinations thereof.