Apparatus and methods for enhancing the functional longevity and for facilitating the implantation of medical devices

• US 6,582,443 B2
• Filed: 12/27/2000
• Issued: 06/24/2003
• Est. Priority Date: 12/27/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Deininger, Steven T., Cabak, James E., Westrum, John W. Jr.
• Primary Examiner(s): Nerbun, Peter
• Assistant Examiner(s): Moran, Katherine M
• Application Number:
  US09/749,301
• Publication Number:
  US 20020082619A1
• Time in Patent Office: 909 Days
• Field of Search: 606/151, 606/148
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Surgical apparatus and associated methods of use are provided for enhancing the functional life-span of medical implants and for facilitating their implantation, particularly for medical devices designed to support anatomical structures. The apparatus comprises a reinforcing fastener guide for fixedly mounting or interlocking onto the surface of a medical device such as a urethral sling or the like. Formed of surgical grade metals or plastics, the attached reinforcing fastener guide defines an easily identified location for the implanting surgeon to position one or more surgical fasteners, such as a suture, to the patient'"'"'s body in order to permanently position the medical implant. This greatly simplifies and shortens the implantation protocol while substantially reducing undesirable mechanical stresses within the implant at these attachment points, thereby increasing the useful life of the implanted medical device.

Claims

1. A self-affixing apparatus for enhancing the functional longevity and for facilitating the implantation of medical devices having first and second major surfaces, said apparatus comprising:

a reinforcing fastener guide having surfaces for abutting the first and second major surfaces of the medical device to fixedly mount on the medical device,

wherein said reinforcing fastener guide is a generally circular, planar disc having at least one fastener aperture therethrough, and

wherein said medical device is a urethal sling provided with a plurality of said reinforcing fastener guides.

2. The apparatus of claim 1, wherein said reinforcing fastener guide is made from a material selected from the group consisting of surgical grade metals and polymers.

3. The apparatus of claim 2, wherein said reinforcing fastener guide is made from surgical-grade stainless steel.

4. An apparatus for enhancing the functional longevity and for facilitating the implantation of medical devices, said apparatus comprising:

a reinforcing fastener guide fixedly mountable upon at least one surface of a medical device, and

at least one external ring affixed to said reinforcing fastener guide.

5. The apparatus of claim 4, wherein said external ring is pivotally attached to said reinforcing fastener guide.

6. The apparatus of claim 4, wherein said external ring is made from surgical grade stainless steel.

7. A self-affixing apparatus for enhancing the functional longevity and for facilitating the implantation of medical devices having first and second major surfaces, said apparatus comprising:

a reinforcing fastener guide having surfaces for abutting the first and second major surfaces of the medical device to fixedly mount on the medical device,

wherein said reinforcing fastener guide includes a generally circular, planar disc having at least one fastener aperture therethrough, and

where the circular, planar disc has grasping formations.

8. A self-affixing apparatus for enhancing the functional longevity and for facilitating the implantation of medical devices having first and second major surfaces, said apparatus comprising:

a reinforcing fastener guide having surfaces for abutting the first and second major surfaces of the medical device to fixedly mount on the medical device,

wherein said reinforcing fastener guide is provided with at least one fixation interlock, and

wherein the fixation interlock comprises a locking pin and the locking pin pierces/cores through the medical device prior to locking engagement.

9. A self-affixing apparatus for enhancing the functional longevity and for facilitating the implantation of medical devices having first and second major surfaces, said apparatus comprising:

a reinforcing fastener guide having surfaces for abutting the first and second major surfaces of the medical device to fixedly mount on the medical device,

wherein said reinforcing fastener guide is provided with at least one fixation interlock, and

wherein said fixation interlock comprises;

at least one locking pin projecting from said reinforcing fastener guide into locking engagement with said medical device.

10. The apparatus of claim 9, wherein said fixation interlock further comprises:

a complimentary reinforcing fastener guide backing plate dimensioned to receive said at least one locking pin in fixed, interlocking relationship.

11. The apparatus of claim 10, wherein backing plate is hinged to said reinforcing fastener guide.

12. The apparatus of claim 10, wherein said reinforcing fastener guide and said backing plate include mating grasping formations.

13. The apparatus of claim 9, wherein said at least one locking pin is configured to pierce and retain a generally planar portion of a medical device.

14. The apparatus of claim 13, wherein said medical device is a sling.

15. A self-affixing apparatus for enhancing the functional longevity and for facilitating the implantation of medical devices having first and second major surfaces, said apparatus comprising:

a reinforcing fastener guide fixedly mountable upon the first and second major surfaces of a medical device,

wherein said reinforcing fastener guide is provided with at least one fixation interlock, and

further comprising a compression ring,

the fixation interlock comprises at least one locking pin projecting from said reinforcing fastener guide and the locking pin pierces/cores through the medical device prior to locking engagement,

wherein the compression ring compresses the medical device upon pin locking and thus distributes stresses along a larger surface area away from the pierced/cored holes.

16. An implantation method for enhancing the functional longevity while facilitating the implantation of a medical device, said method comprising the steps of:

fixedly mounting at least one reinforcing fastener guide to at least one portion of a medical device prior to implantation of said device;

positioning said reinforced fastener guide mounted medical device at a desired location within a patient'"'"'s body; and

placing at least one surgical fastener through each of said at least one reinforcing fastener guide.

17. The method of claim 16, wherein said surgical fastener is a suture.

18. The method of claim 16, wherein said medical device is a urethral sling.

19. A generally planar urethral sling provided with a plurality of self-affixing apparatuses for enhancing the functional longevity and for facilitating the implantation of the urethral sling, the urethral sling having first and second major surfaces and edges, said self-affixing apparatuses comprising:

a reinforcing fastener guide fixedly mountable upon the first and second major surfaces of the urethral sling,

wherein said reinforcing fastener guide is provided with at least one fixation interlock, and

the self-affixing apparatuses being disposed adjacent the edges of said urethral sling and fixedly interlocked thereto.