Pelvic implant systems and methods with expandable anchors

• US 8,852,075 B2
• Filed: 06/12/2011
• Issued: 10/07/2014
• Est. Priority Date: 10/12/2000
• Status: Expired due to Fees

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US13/158,426
• Publication Number:
  US 20110237878A1
• Time in Patent Office: 1,213 Days
• Field of Search: 600 29- 31, 600/37, 606139-158
• US Class Current: 600/30
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An implant for supporting pelvic anatomy includes a first soft tissue anchor, a second soft tissue anchor, and a support portion. The first and second soft tissue anchors each include a central portion and a plurality of projections biased radially from the central portion of the soft tissue anchors, respectively. The implant is configured for selective adjustment of an effective length of the implant between the first and second soft tissue anchors.

Claims

1. An implant for supporting pelvic anatomy, the implant comprising:

a first soft tissue anchor comprising a central portion and a plurality of projections biased radially from the central portion of the first soft tissue anchor;

a second soft tissue anchor comprising a central portion and a plurality of projections biased radially from the central portion of the second soft tissue anchor; and

a support portion connected to the first and second soft tissue anchors; and

an introducing tool having a handle directly coupled to an elongate shaft and further comprising a collar, the collar being configured to confine the plurality of projections during insertion of the first soft tissue anchor into the pelvic anatomy, wherein withdrawal of the introducing tool after insertion of the first soft tissue anchor into soft tissue of the pelvic anatomy removes the collar from around the plurality of projections of the first soft tissue anchor such that the plurality of projections expand from the central portion of the first soft tissue anchor to engage soft tissue and anchor the support portion at a desired location in the pelvic anatomy.

2. The system of claim 1, wherein the collar releasably retains the plurality of projections of the first soft tissue anchor in a confined state.

3. The system of claim 2, wherein the collar has a cross-sectional opening configured such that withdrawing the introducing tool removes the collar from the implant such that the implant passes through the cross-sectional opening in the collar.

4. A surgical method comprising:

retaining a plurality of radially biased projections of a first soft tissue anchor of a pelvic implant in a radially confined state with a collar of an introducer;

making an incision in a vaginal wall of a patient;

inserting the introducer and first soft tissue anchor through the incision in the vaginal wall into soft tissue of a pelvic space of the patient, the introducer including a handle directly attached to a shaft and further comprising the collar;

inserting the first soft tissue anchor into soft tissue of the pelvic anatomy followed by withdrawing the introducer wherein withdrawing the introducer removes the collar from around the plurality of projections of the first soft tissue anchor such that the plurality of projections transition to a radially expanded state to engage the soft tissue;

supporting a sling of the pelvic implant under a urethra of the patient with the first soft tissue anchor and a second soft tissue anchor without penetrating a rectus sheath of the patient.

5. The method of claim 4, further comprising adjusting a length of the pelvic implant between the first and second soft tissue anchors.

6. An implant for supporting pelvic anatomy, the implant comprising:

a first retaining portion formed of a resilient material and comprising a plurality of projections adapted for fixation in soft tissue of a pelvic space;

a second retaining portion formed of a resilient material and comprising a plurality of projections adapted for fixation in soft tissue of a pelvic space;

a support portion positioned between the first and second retaining portions, the support portion being configured to support a urethra of a patient;

an introducer having a handle directly coupled to a shaft and further comprising a collar, the collar being adapted to penetrate into soft tissue while maintaining the first retaining portion in a collapsed state during insertion of the introducer into the retropubic space, the first retaining portion being configured to resiliently transition to an expanded state upon removal of the collar of the introducer during withdrawal of the introducer, wherein withdrawal of the introducer after insertion of the first retaining portion into soft tissue of the pelvic anatomy results in removal of the collar from the first retaining portion.

7. The implant of claim 6, wherein the introducer includes a recess configured to receive the first retaining portion and to retain the first retaining portion in a preselected orientation.

8. The implant of claim 6, wherein the collapsed state of the first retaining portion includes the plurality of projections being positioned more closely to the one another than in the expanded state.

9. A method of supporting pelvic anatomy, the method comprising:

maintaining a first retaining portion of a pelvic implant in a collapsed state with a collar of an introducer, the introducer having a handle directly coupled to an elongate shaft, the first retaining portion being formed of a resilient material and comprising a plurality of projections adapted for fixation in soft tissue;

making an incision in a vaginal wall of a patient;

inserting the introducer and first retaining portion through the incision in the vaginal wall into soft tissue of a pelvic space of the patient without penetrating a rectus sheath of the patient;

inserting the first retaining portion into soft tissue of the pelvic anatomy followed by withdrawing the introducer wherein withdrawing the introducer removes the collar from around the first retaining portion such that the plurality of projections of the first retaining portion transition to an expanded state to engage the soft tissue;

inserting a second retaining portion of the pelvic implant into soft tissue of a pelvic space of the patient without penetrating a rectus sheath of the patient; and

maintaining a support portion of the pelvic implant under a urethra of the patient with the first retaining portion and a second retaining portion.

10. The method of claim 9, wherein maintaining the first retaining portion of the pelvic implant in the collapsed state with the collar of the introducer includes positioning the first retaining portion in a recess in the collar.

11. The method of claim 9, wherein the plurality of projections transition to an expanded state by moving outwardly away from one another to the expanded state.