PELVIC IMPLANT SYSTEMS AND METHODS WITH EXPANDABLE ANCHORS

• US 20110237878A1
• Filed: 06/12/2011
• Published: 09/29/2011
• Est. Priority Date: 10/12/2000
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Granted Patent: US 8,852,075 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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
• 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;

wherein the implant is configured for selective adjustment of an effective length of the implant between the first and second soft tissue anchors.

2. The system of claim 1, further comprising an introducing tool for confining the plurality of projections for insertion into the pelvic anatomy such that upon release of the soft tissue anchor from the introducing tool the plurality of projections expand from the central portion to engage soft tissue and anchor the sling at a desired location in the pelvic anatomy.

3. The system of claim 1, wherein the introducing tool comprises a collar which releasably retains the projections in a confined state.

4. The system of claim 2, wherein the collar of the introducing tool has a cross-sectional opening configured such that once the tool is withdrawn the collar may be removed from the surgical implant by passing the implant through the cross-sectional opening in the collar.

5. 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 an introducer;

making an incision in a vaginal wall of a patient;

inserting the first soft tissue anchor through the incision in the vaginal wall into soft tissue of a pelvic space of the patient with the introducer;

releasing the first soft tissue anchor from the introducer 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.

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

7. 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 tip adapted to maintain the first retaining portion in a collapsed state, the first retaining portion being configured to resiliently transition to an expanded state upon being released from the tip of the introducer.

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

9. The implant of claim 7, wherein the introducer is configured to release the retaining portion of the implant during withdrawal of the introducer from the pelvic space.

10. The implant of claim 7, wherein the collapsed state of the retaining portion includes the plurality of projections being positioned more closely to the one another than in the expanded state.

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

maintaining a first retaining portion of a pelvic implant in a collapsed slate with a tip of an introducer, the introducer having an elongate shaft and a handle, 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 first retaining portion through the incision in the vaginal wall into soft tissue of a pelvic space of the patient with the introducer without penetrating a rectus sheath of the patient;

releasing the first retaining portion from the introducer such that the plurality of projections 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 soft tissue anchor and a second soft tissue anchor.

12. The method of claim 11, wherein maintaining the first retaining portion of the pelvic implant in a collapsed state with the tip of the introducer includes positioning the first retaining portion in a recess in the tip.

13. The method of claim 11, wherein releasing the first retaining portion from the introducer includes withdrawing the introducer from the pelvic space.

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