Self-anchoring sling and introducer system

• US 9,005,222 B2
• Filed: 01/13/2012
• Issued: 04/14/2015
• Est. Priority Date: 08/02/2002
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: Coloplast A/S
• Inventors: Evans, Douglas G., Butcher, Ken, Davis, Michele Gandy
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/350,655
• Publication Number:
  US 20120116154A1
• Time in Patent Office: 1,187 Days
• US Class Current: 606/151
• 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 for prosthetic joint-implanting tools A61F2/4603
• 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 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61B 2017/0609 having sharp tips at both ends, e.g. shuttle needle alternately retained and released by first and second facing jaws of a suturing instrument MIS suturing instruments A61B17/0469; jaws of MIS forceps A61B2017/2926
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A system for supporting the urethra using an introducer needle, the ends of which are flattened and which have openings therethrough, a handle having a latch mechanism which engages the opening in the flattened portion of the first end of the introducer needle, an implant, and a connector joining the end of the implant to the flattened portion of one of the ends of the introducer needle. These components are used to draw the implant into position, either through vaginal or abdominal incisions, to form a U-shaped loop beneath the urethra. The ends of the implant are adjusted to provide proper support for the urethra. The implant can have slits that open under applied tensile force.

Claims

1. A system to implant a support member, comprising:

an introducer needle having a first end and a second end, each of the first end and second end including a flattened portion with an opening therethrough;

a handle having a latch mechanism engaging the opening in the flattened portion of the first end of the introducer needle;

a support member having an end; and

a connector joining the end of the support member to the flattened portion of the second end of the introducer needle, the connector comprising;

a central portion;

a first pair of arms, including a first lower arm pivotally mounted to the central portion and having a first projection, and a first upper arm pivotally mounted to the central portion and having a first opening positioned to receive the first projection when the first lower arm and first upper arm are brought together into a locking relationship; and

a second pair of arms, each of the second pair of arms pivotally mounted to the central portion.

2. The system according to claim 1, wherein at least a portion of the introducer needle is curved and symmetrical.

3. The system according to claim 1, wherein the flattened portion of the first end differs in at least one of size and shape from the flattened portion of the second end.

4. The system according to claim 1, wherein the introducer needle has a flared section having a cross-sectional profile that, in a given direction, is at least as large as a cross-sectional profile of the connector in the given direction.

5. The system according to claim 1, wherein the introducer needle has a rounded tip.

6. The system according to claim 1, wherein the introducer needle has an asymmetric shape.

7. The system according to claim 1, wherein a tip of the first flattened portion has a first configuration and a tip of the second flattened portion has a second configuration different from the first configuration.

8. The system according to claim 1, wherein the introducer needle has an arcuate shape.

9. The system according to claim 1, wherein at least a portion of the introducer needle has an oval cross section.

10. The system according to claim 1, wherein at least a portion of the introducer needle has a circular cross-section.

11. The system according to claim 1, wherein the second pair of arms includes a second lower arm having a second projection, and a second upper arm having a second opening positioned to receive the second projection when the second lower arm and second upper arm are brought together into a locking relationship.

12. The system according to claim 1, wherein the first upper arm and one of the second pair of arms includes a plurality of openings.

13. The system according to claim 12, wherein the plurality of openings of each of the first upper arm and one of the second pair of arms are arranged in a two-dimensional pattern.

14. The system according to claim 1, wherein the support member comprises an elongated body made of a flexible material having a first end, a second end, and a support portion, the support portion having an axis running along the length of the implant member, the support portion having a plurality of slits arranged along at least a portion of the axis.

15. The system according to claim 14, wherein the slits are selected from the group consisting of V-shaped, semicircular, rectangular, oval, and arrowhead shaped.

16. The system according to claim 1, wherein at least one of the first pair of arms and second pair of arms include a set of opposing and interlocking teeth dimensioned and disposed to mate when the at least one of the first pair of arms and second pair of arms are brought into a locking relationship.

17. The system according to claim 1, wherein the first lower arm includes a boss having a height less than a height of the first projection to establish a minimum separation distance between the first lower arm and first upper arm when the first lower arm and first upper arm are brought together into a locking relationship.

18. The system according to claim 17, wherein the boss has a cross-sectional shape in the form of a “

+”

.

19. A system to implant a support member, comprising:

an introducer needle having a first end and a second end, each of the first end and second end including a flattened portion with an opening therethrough;

a handle having a latch mechanism engaging the opening in the flattened portion of the first end of the introducer needle;

a support member having an end; and

a connector joining the end of the support member to the flattened portion of the second end of the introducer needle, the connector comprising;

a central portion;

a first pair of arms, including a first lower arm rigidly mounted to the central portion and having a first opening, and a first upper arm pivotally mounted to the central portion and having a first projection to be received in the first opening when the first upper arm is pivoted into locking relationship with the first lower arm; and

a second pair of arms, including a second lower arm rigidly mounted to the central portion and having a second opening, and a second upper arm pivotally mounted to the central portion and having a second projection to be received in the second opening when the second upper arm is pivoted into locking relationship with the second lower arm.