MEDICAL DEVICES, SYSTEMS AND METHODS FOR RAPID DEPLOYMENT AND FIXATION OF TISSUE ANCHORS

• US 20100256679A1
• Filed: 04/02/2010
• Published: 10/07/2010
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: DUCHARME, RICHARD W.
• Granted Patent: US 8,382,776 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061

Abstract

Medical devices, systems and related methods for delivering a plurality of tissue anchors. The medical devices generally comprise a needle and an over-the-needle suture lock, employed via inner and outer sheaths. The medical systems include a plurality of tissue anchors and at least one biodegradable or resorbable spacer member positioned between adjacent tissue anchors in conjunction with the medical devices.

Claims

1. A medical device for delivering a plurality of tissue anchors through tissue, each tissue anchor having an anchoring member connected to a suture, the medical device comprising:

a needle having a needle lumen sized to slidably receive the plurality of tissue anchors, the needle and the needle lumen defining a longitudinal axis of the medical device, the plurality of tissue anchors including first and second tissue anchors;

at least one spacer member positioned between the first and second tissue anchors within the needle lumen;

a suture lock for fixing the suture after delivery of the tissue anchors, the suture lock comprising,

a plug having a main body having a first internal wall defining a first internal passageway sized to slidably receive the needle, and

a retaining sleeve having a tubular body having a second internal wall defining a second internal passageway sized to receive the plug therein and engage the suture of the plurality of tissue anchors between the plug and the second internal wall of the retaining sleeve;

an inner sheath having an inner sheath lumen sized to slidably receive the needle, wherein the inner sheath is sized and positioned to abut the plug, wherein translation of the inner sheath causes the plug to slide over-the-needle; and

an outer sheath having an outer sheath lumen sized to slidably receive the inner sheath and the plug, wherein the outer sheath is sized and positioned to abut the retaining sleeve.

2. The medical device of claim 1, wherein the plug includes a grip and a stop, the stop extending radially from the main body defining a first shoulder facing proximally, wherein the retaining sleeve includes a peripheral rim extending radially from the tubular body defining a second shoulder facing proximally, wherein the inner sheath is sized and positioned to abut the first shoulder of the plug, and wherein the outer sheath is sized and positioned to abut the second shoulder of the retaining sleeve.

3. The medical device of claim 2, wherein the suture lock is operable between an unlocked configuration during delivery of the plurality of tissue anchors through tissue and a locked configuration after delivery of the plurality of tissue anchors through tissue, the plug and the retaining sleeve being separated in the unlocked configuration and being connected in the locked configuration, the plug and the retaining sleeve sized and structured to compress the suture of the plurality of tissue anchors between the grip of the plug and the second internal wall of the retaining sleeve in the locked configuration.

4. The medical device of claim 1, wherein the first and second tissue anchors include respective first and second anchoring members, the first and second anchoring members and the spacer member being serially aligned within the needle lumen, the medical device further comprising a pusher slidably received within the needle lumen, the pusher sized and positioned to engage the proximal-most anchoring member of the plurality of tissue anchors.

5. The medical device of claim 1, wherein the medical device is operable between a delivery configuration and a deployed configuration, the inner sheath, the plug, and the needle being substantially contained within the outer sheath lumen in the delivery configuration, the needle projecting beyond a distal end of the outer sheath and the retaining sleeve in the deployed configuration.

6. The medical device of claim 1, wherein the suture of the plurality of tissue anchors extends proximally and in between the plug and the retaining sleeve.

7. The medical device of claim 1, wherein the suture of the plurality of tissue anchors extends in a proximal direction along an exterior of the inner sheath and within the outer sheath lumen.

8. The medical device of claim 1, wherein the suture of the plurality of tissue anchors is pre-loaded within the suture lock.

9. The medical device of claim 1, wherein a distal end of the needle defines a needle slot sized to receive the suture of the plurality of tissue anchors therein, the needle slot including a slot length dependent upon the number and the length of the anchoring members of the plurality of tissue anchors and upon the number and length of the spacer members received within the needle lumen.

10. A medical system comprising:

at least one tissue anchor, the tissue anchor having an anchoring member connected to a suture;

a needle having a needle lumen sized to slidably receive the tissue anchor, the needle and needle lumen defining a longitudinal axis, a distal end of the needle defining a needle slot sized to receive the suture therein;

a suture lock for fixing the suture after delivery of the tissue anchor through tissue, the suture lock including a plug and a retaining sleeve, the plug having a main body including a grip extending radially therefrom and a first internal wall defining a first internal passageway, the retaining sleeve having a tubular body with a second internal wall defining a second internal passageway sized to receive the plug and its grip therein, the grip sized to compress the suture against the second internal wall, both the first and second internal passageways sized to slidably receive the needle during delivery of the tissue anchor;

an inner sheath engageable with the plug and having an inner sheath lumen sized to slidably receive the needle; and

an outer sheath engageable with the retaining sleeve and having an outer sheath lumen sized to slidably receive the inner sheath and the plug.

11. The medical system of claim 10, wherein the suture lock is operable between a locked configuration and an unlocked configuration, the plug and the retaining sleeve being connected in the locked configuration and being separated in the unlocked configuration, the plug and the retaining sleeve sized and structured to compress the suture between the plug and the second internal wall of the tubular body of the retaining sleeve in the locked configuration.

12. The medical system of claim 10, wherein the medical system is operable between a delivery configuration and a deployed configuration, the inner sheath, the plug, and the needle being substantially contained within the outer sheath lumen in the delivery configuration, the needle projecting beyond a distal end of the outer sheath and the retaining sleeve in the deployed configuration.

13. The medical system of claim 10, further comprising a plurality of tissue anchors each having an anchoring member connected to a suture, and wherein the anchoring members are serially aligned within the needle lumen.

14. The medical system of claim 13, further comprising a pusher slidably received within the needle lumen, the pusher sized and positioned to engage the proximal-most anchoring member of the plurality of tissue anchors.

15. The medical system of claim 13, wherein the plurality of tissue anchors includes first and second tissue anchors having first and second respective anchoring members, the medical system further comprising at least one resorbable spacer member disposed between the first and second anchoring members within the needle lumen.

16. The medical system of claim 10, wherein the plug includes a stop extending radially from the main body to define a first shoulder facing proximally and the retaining sleeve includes a peripheral rim extending radially from the tubular body to define a second shoulder facing proximally, wherein the inner sheath engages the first shoulder and the outer sheath engages the second shoulder.

17. A method of delivering at least one tissue anchor through tissue, the tissue anchor having an anchoring member connected to a suture, the method comprising:

providing a medical device comprising a needle, inner and outer sheaths, and a suture lock, the needle having a needle lumen sized to slidably receive the tissue anchor, a distal end of the needle defining a needle slot sized to receive and engage the suture therein, the suture lock including a plug and a retaining sleeve, the plug having a main body with a first internal wall defining a first internal passageway, the retaining sleeve having a tubular body with a second internal wall defining a second internal passageway sized to receive the plug therein, the plug sized to engage the suture within the second internal passageway of the retaining sleeve when in a locked configuration, both the first and second internal passageways sized to slidably receive the needle, the inner sheath engageable with the plug and having an inner sheath lumen sized to slidably receive the needle, and the outer sheath engageable with the retaining sleeve and having an outer sheath lumen sized to slidably receive the inner sheath and the plug;

delivering the medical device to a position proximate the tissue;

deploying the needle by translating the needle relative to the inner and outer sheaths; and

deploying the tissue anchor by translating the tissue anchor relative to the needle such that the tissue anchor exits the needle lumen.

18. The method of claim 17, further comprising the step of fixing the suture relative to the tissue by:

engaging the retaining sleeve with the outer sheath;

positioning the retaining sleeve proximate the tissue with the suture extending through the second internal passageway;

placing the suture in tension;

engaging the plug with the inner sheath;

positioning the plug within the second internal passageway of the retaining sleeve such that the suture is compressed between the plug and the retaining sleeve.

19. The method of claim 18, further comprising the step of pulling the suture in a proximal direction while pushing the inner sheath and the plug distally, the inner sheath and the plug being pushed distally relative to the outer sheath and the retaining sleeve.

20. The method of claim 17, wherein the medical device includes a plurality of tissue anchors serially aligned within the needle lumen, and wherein the step of deploying the tissue anchor is repeated for at least a portion of the plurality of tissue anchors.