Coaxial device for delivering an implant to a patient's pelvic region

• US 20080132753A1
• Filed: 10/03/2007
• Published: 06/05/2008
• Est. Priority Date: 10/03/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Goddard, James
• Granted Patent: US 8,974,367 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor

Abstract

Systems and methods for implanting a surgical sling in a patient by a transobturator approach are disclosed. A sling delivery device couplable to a sling assembly with the surgical sling includes a guide tube and an extendible shaft section movable inside the guide tube. At least a portion of the shaft may be made of a shape memory material and can, when extended, assume a shape different from the shape of the guide tube in which the shaft is housed. This allows the extended shaft to navigate along a path that tracks close to bone structures, in particular the ischiopubic ramus, and prevents damage to surrounding tissue.

Claims

1. A device for delivering an implant to a patient'"'"'s pelvic region comprising:

a guide tube with a proximal end, a distal end and a first radius of curvature; and

a shaft slidingly interfitted in the guide tube with a proximal end and a distal end, said shaft adapted to extend from the distal end of the guide tube in a first position and retract into the distal end of the guide tube in a second position;

wherein the shaft has a radius of curvature substantially equal to the first radius of curvature when retracted in the guide tube, and wherein at least a section of the shaft assumes a second radius of curvature different from the first radius of curvature of the guide tube, when the section of the shaft extends from the guide tube.

2. The device of claim 1, wherein at least the section of the shaft is preformed with the second radius of curvature before being inserted in the guide tube.

3. The device of claim 1, wherein at least the section of the shaft comprises a shape memory material.

4. The device of claim 3, wherein the shape memory material comprises a nickel titanium alloy.

5. The device of claim 3, wherein the shape memory material has a phase transition temperature in a range of a body temperature of a mammal.

6. The device of claim 1, further comprising a handle joined to the proximate end of the guide tube.

7. The device of claim 6, further comprising an actuator secured on the handle and operatively connected to the proximal end of the shaft for extending at least the section of the shaft from the distal end of the guide tube and retracting at least the section of the shaft into the distal end of the guide tube.

8. The device of claim 1, further comprising a connector adapted to attach to a sling assembly, said connector attached to or integrally formed with the distal end of the shaft.

9. The device of claim 1, wherein the shaft comprises a lumen and a heating or cooling element disposed in the lumen in at least the section of the shaft made of the shape memory material.

10. The device of claim 9, wherein the heating element is energized to increase the temperature of the shape memory material above a phase transition temperature of the shape memory material when at least the section of the shaft made of the shape memory material is extended to protrude from the distal end of the guide tube.

11. The device of claim 9, wherein the cooling element is energized to decrease the temperature of the shape memory material below a phase transition temperature of the shape memory material when at least the section of the shaft made of the shape memory material is retracted toward the distal end of the guide tube.

12. The device of claim 1, wherein the second radius of curvature of the extended section is smaller than the first radius of curvature of the guide tube.

13. A sling delivery assembly comprising:

a delivery device having

a guide tube with a proximal end and a distal end, said distal end of the guide tube having a first radius of curvature,

a shaft slidingly interfitted in the guide tube and having a proximal end and a distal end, said distal end of the shaft having a radius of curvature substantially identical to the first radius of curvature while inside the guide tube and being adapted to protrude from the distal end of the guide tube with a second radius of curvature different from the first radius of curvature, and

a first connector attached to or integrally formed with the distal end of the shaft; and

a sling assembly having a proximal end and a distal end, and a second connector attached to or integrally formed with the distal end of the sling assembly and adapted for engagement with the first connector.

14. The assembly of claim 13, wherein the delivery device further comprises a dilator tip or tissue dissector disposed on the distal end of the shaft.

15. The assembly of claim 13, wherein the second connector of the sling assembly is formed as a dilator.

16. The assembly of claim 13, wherein the delivery device further comprises:

a handle secured to the proximate end of the guide tube; and

an actuator disposed on or in the handle for causing the distal end of the shaft to protrude from and be retracted toward the distal end of the guide tube

17. The assembly of claim 13, wherein the shaft comprises a lumen and a heating or cooling element disposed in the lumen in at least the portion of the shaft made of the shape memory material.

18. The assembly of claim 17, wherein the heating element is energized to increase the temperature of the shape memory material above a phase transition temperature of the material when at least the portion of the shaft made of the shape memory material is extended to protrude from the distal end of the guide tube.

19. The assembly of claim 17, wherein the cooling element is energized to decrease the temperature of the shape memory material below a phase transition temperature of the material when at least the portion of the shaft made of the shape memory material is retracted in the distal end of the guide tube.

20. The assembly of claim 13, wherein the shape memory material comprises a nickel titanium alloy.

21. The assembly of claim 13, wherein the shape memory material has a phase transition temperature in a range of a body temperature of a mammal.

22. The assembly of claim 13, wherein the second radius of curvature of the distal end of the shaft is smaller than the first radius of curvature of the guide tube.

23. A method of implanting a surgical sling into the pelvic region of a patient, the method comprising:

inserting a delivery device coupled to a sling assembly with a surgical sling through an incision of a patient; and

extending a shaft portion from a distal end of the delivery device to navigate around a bodily structure, said extended shaft portion assuming a curvature different from a curvature of the distal end of the delivery device.

24. The method of claim 23, further comprising retracting the extended shaft portion after placement of the surgical sling, with the retracted shaft portion conforming to the curvature of the distal end of the delivery device.

25. The method of claim 24, further comprising cooling at least the extended shaft portion when the shaft is retracted.

26. The method of claim 24, further comprising heating at least the extended shaft portion when the shaft is extended.

27. The method of claim 23, further comprising advancing the delivery device to the vicinity of an obturator foramen.

28. The method of claim 27, wherein advancing the delivery device includes penetrating the obturator foramen and extending the shaft portion around and in close proximity to the ischiopubic ramus.