US20140257026A1 - Adjustable implants and methods of implanting the same - Google Patents

Abstract

In one embodiment, a medical device includes a tissue anchor has a first portion and a second portion. The tissue anchor is configured to be placed within bodily tissue of a patient. The first portion of the tissue anchor includes an extension member configured to engage the bodily tissue to help retain the tissue anchor within the bodily tissue. The first portion has an inner surface and defines a cavity. The second portion of the tissue anchor has a helical ridge. The helical ridge is configured to engage the inner surface of the first portion of the tissue anchor to movably couple the second portion of the tissue anchor to the first portion of the tissue anchor.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a Nonprovisional of, and claims priority to, U.S. Patent Application No. 61/775,079, filed on Mar. 8, 2013, entitled “ADJUSTABLE IMPLANTS AND METHODS OF IMPLANTING THE SAME”, which is incorporated by reference herein in its entirety.
TECHNICAL FIELD
• This disclosure relates generally to medical devices and more particularly to implants configured to provide support within a body of a patient and methods for securing such implants with the body of the patient.
BACKGROUND
• A variety of medical procedures are performed to provide support to portions of a body of a patient. For example, some medical procedures are performed to treat various female pelvic dysfunctions, including procedures to treat urinary incontinence, and correcting various prolapse conditions such as uterine prolapse, cystoceles, rectoceles, and vaginal vault prolapse. Additionally, some medical procedures are performed to treat various male pelvic dysfunctions, such as urinary incontinence.
• Women often experience vaginal prolapses due to age or other factors. For example, women may experience a cystocele, a rectocele and/or a hysterocele. A cystocele occurs when the bladder bulges into the vagina, and a rectocele occurs when the rectum bulges into the vagina. A hysterocele occurs when the uterus descends into the vagina. An enterocele (small bowel prolapse) can also occur, when the small bowel pushes through the upper wall of the vagina.
• Treatments of such dysfunctions have included suturing procedures or the use of implants for support or suspension of a portion of a body of a patient. For example, a hysterocele is often treated with a hysterectomy followed by a vaginal vault suspension. Various devices and procedures are used to deliver and secure pelvic implants within a variety of different anatomical structures within a pelvic region. Implants can be delivered to a pelvic region through one or more vaginal incisions, and/or through exterior incisions in the patient.
• Existing implants differ in many ways including size, shape, material, number and location of straps, and in the method in which they are delivered and placed within a pelvic region. Additionally, depending on the particular condition to be treated and the implant used, pelvic floor repair can require various fixation locations within a pelvic region. For example, an implant can be secured using a number of anchors disposed at various fixation points.
• It may be difficult to insert known implants and apply the correct tension to the known implants during the implantation procedure. Thus, it would be beneficial to provide an implant and system that facilitates the implantation of the implant and the tensioning of the implant during the implantation procedure. It would also be beneficial to provide an implant and system that that facilitates the adjustment of the effective length, such as the length between the anchors, of an implant.
SUMMARY
• In one embodiment, a medical device includes a tissue anchor has a first portion and a second portion. The tissue anchor is configured to be placed within bodily tissue of a patient. The first portion of the tissue anchor includes an extension member configured to engage the bodily tissue to help retain the tissue anchor within the bodily tissue. The first portion having an inner surface and defining a cavity. The second portion of the tissue anchor has a helical ridge. The helical ridge is configured to engage the inner surface of the first portion of the tissue anchor to movably couple the second portion of the tissue anchor to the first portion of the tissue anchor. Accordingly, the medical device is a medical device that includes a size or a length that can be adjusted.
• In another embodiment, a medical device includes an elongate member, a shaft member, and an actuator. The elongate member has a proximal end portion and a distal end portion. The elongate member defines a cavity. The shaft member is at least partially disposed within the cavity of the elongate member. The shaft member is configured to rotate with respect to the elongate member. The actuator is operatively coupled to the shaft member and is configured to cause the shaft member to rotate with respect to the elongate member. Accordingly, the medical device is a medical device that includes a size or a length that can be adjusted.
• In yet another embodiment, a method of placing a medical device within a body of a patient includes inserting a tissue anchor into the body of the patient, the tissue anchor having a first portion and second portion; and rotating the second portion of the tissue anchor with respect to the first portion of the tissue anchor.
• The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features will be apparent from the description and drawings, and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic illustration of a medical device according to an embodiment of the invention.
• FIG. 2 is a top view of a medical device according to an embodiment of the invention.
• FIG. 3 is a perspective view of an anchor of the medical device ofFIG. 2.
• FIG. 4 is a side view of the anchor ofFIG. 3.
• FIG. 5 is a perspective view of a first portion of the anchor ofFIG. 3.
• FIG. 6 is a perspective view of the second portion of the anchor ofFIG. 3.
• FIG. 7 is a top view of an implant according to an embodiment of the invention.
• FIG. 8 is a side view of an insertion tool of the medical device ofFIG. 2.
• FIG. 9 is a cross-sectional view of the insertion tool taken along line9-9 ofFIG. 8.
• FIG. 10 is a distal end view of the insertion tool ofFIG. 8
• FIG. 11 is a proximal end view of the insertion tool ofFIG. 8.
• FIG. 12 is a top view of an implant according to an embodiment of the invention.
• FIG. 13 is a side view of an anchor of the implant ofFIG. 12.
• FIG. 14 is a schematic view of an implant disposed within a body of a patient.
• FIG. 15 is a flow chart of a method according to an embodiment of the invention.
DETAILED DESCRIPTION
• The devices and methods described herein are generally directed to implants configured to be disposed within a body of a patient. In some embodiments, the implants are pelvic implants (e.g., posterior support implants, anterior support implants, total pelvic floor repair implants) and the delivery and placement of such implants within a pelvic region (also referred to herein as “pelvis”) of a patient. An implant can be placed into the pelvic space of a patient and secured at any of several locations within the pelvic space to treat many different pelvic floor dysfunctions. For example, an implant can be secured to a sacrospinous ligament or a ureterosacral ligament for uterine preservation (e.g., if a prolapsed uterus is otherwise healthy, a hysterectomy is not preformed and the uterus is re-suspended with an implant), or for posterior support. In another embodiment, an implant can be secured to pubo-urethral tissue or an obturator muscle (e.g., internus or externus) or membrane (each also referred to herein as “obturator”) to treat, for example, incontinence. In yet another embodiment, an implant can be secured to a sacrospinous ligament or an arcus tendineus fascia pelvis (i.e., white line) (also referred to herein as “arcus tendineus”) for paravaginal repairs including, for example, cystoceles, rectoceles and enteroceles. An implant can also be secured to various combinations of such locations. A single implant or multiple implants can be used in a single procedure. In some applications, when multiple implants are used, support can be provided in desired areas and improved control of the direction of stretch or support of the implant can be achieved. Various delivery devices, delivery aids, and methods are also described for delivering and securing an implant assembly within the patient. The implants and procedures described herein may be used in a female patient or a male patient.
• An implant according to an embodiment of the invention can be implanted, for example, through a vaginal incision, in a retro-pubic direction (behind the pubic bone), in a pre-pubic direction (in front of the pubic bone). In other embodiments, an implant can be placed in the direction of other anatomical structures or tissues as desired. A procedure to deploy a pelvic implant can include vaginal incisions, such as an anterior vaginal incision and/or an anterior vaginal incision. In some embodiments, a procedure may include an exterior incision.
• Various embodiments of implants are described herein. The implants can be delivered to various parts of the body of the patient using a variety of different method and delivery devices. The implants and methods disclosed herein include pelvic floor implants, but the implants may be configured to be placed and methods may be used to place such implants in any portion of the body of the patient.
• An implant can be delivered to a pelvic region of a patient using a variety of different delivery devices, only some examples of which are described herein.
• FIG. 1 is a schematic illustration of a medical device orsystem100. Themedical device100 includes animplant110 and aninsertion tool150. Theimplant110 has asupport member120. Thesupport member120 includes afirst end portion122 coupled to a first mesh carrier oranchor130 and asecond end portion124 coupled to a second mesh carrier oranchor140.
• Theimplant110 is configured to be placed within a body of a patient to provide support to a portion of the body of the patient. For example, in some embodiments, thesupport member120 of theimplant110 is configured to be placed proximate or adjacent a bladder of a patient to provide support to the bladder of the patient. In other embodiments, thesupport member120 of the implant is configured to support the urethera or bladder neck of a patient. In yet other embodiments, thesupport member120 of theimplant110 is configured to be placed adjacent another portion of the body to provide support to another portion of the body.
• The support member includesend portions122 and124. Theimplant110 also includes mesh carriers or anchors130 and140 coupled to endportions122 and124 of thesupport member120. In some embodiments, theanchors130 and140 are directly coupled to theend portions122 and124 of thesupport member120. In other embodiments, a tether or suture is coupled between theend portions122 and124 and theanchors130 and140. Any known mechanism may be used to couple theanchors130 and140 to thesupport member120. For example, an adhesive may be used to couple theanchors130 and140 to thesupport member120. Alternatively, theanchors130 and140 may surround and be frictionally coupled to thesupport member120.
• Theanchors130 and140 are configured to be disposed in bodily tissue and provide a support forimplant110. Specifically, once disposed within bodily tissue, theanchors130 and140 are configured to help retain theimplant110 in place within a body of a patient. In some embodiments, theanchors130 and140 are configured to be disposed within pelvic tissue of a patient. In other embodiments, theanchors130 and140 are configured to be disposed in other bodily tissue, such as muscle tissue.
• In some embodiments, theanchors130 and140 include barbs or projections that are configured to help secure theanchors130 and140 in place within the bodily tissue. In some embodiments, theanchors130 and140 do not include any sort of structure for securing the anchors in place within the body of the patient.
• In the illustrated embodiment, theanchor130 includes afirst portion132 and asecond portion134. Thefirst end portion122 of thesupport member120 is coupled to thesecond portion134 of theanchor130. Thesecond portion134 of theanchor130 is configured to move with respect to thefirst portion132 of theanchor130. For example, in some embodiments, thesecond portion134 of theanchor130 is configured to selectively move with respect to thefirst portion132 of theanchor130. In such an embodiment, thesecond portion134 can be moved with respect to thefirst portion132 of theanchor130 to a desired location and then locked or fixed with respect to thefirst portion132 of the anchor130 (to no longer move with respect to thefirst portion132 of the anchor130). In some embodiments, thesecond portion134 of theanchor130 is configured to rotate with respect to thefirst portion132 of theanchor130. In some such embodiments, thesecond portion134 of theanchor130 moves with respect to thefirst portion132 of theanchor130 is a screw type manner. In other embodiments, the second portion of the anchor is configured to be selectively coupled to the first portion of the anchor via a different mechanism. For example, in some embodiments, the second portion may be configured to be frictionally fit or coupled to the first portion. In other embodiments, tapered surfaces or clamping mechanisms may be used to selectively or movably couple the second portion of the anchor to the first portion of the anchor.
• In some embodiments, theanchor130 may be disposed within the body of the patient. For example, the anchor may be placed within in bodily tissue such that a barb or other projection of the anchor130 (such as a barb or other projection disposed on or extending from thefirst portion132 of the anchor130) engages body tissue to couple theanchor130 to the bodily tissue. The tension or location of theimplant110 may then be adjusted by moving thesecond portion134 with respect to thefirst portion132 of theanchor130.
• In some embodiments, theanchor140 is a two part anchor (similar to anchor130). In other embodiments, theanchor140 is a one part anchor (or an anchor that does not include any portions that are configured to move with respect to each other).
• Theinsertion tool150 of themedical device100 is configured to place theimplant110 into the body of the patient. For example, in some embodiments, theinsertion tool150 is configured to engage theimplant110 and guide the implant into position within the body of the patient. In some embodiments, theinsertion tool150 is configured to engage thesecond portion134 of theanchor130 to deliver or guide theanchor130 into place within the body of the patient. In some embodiments, theinsertion tool150 is configured to cause thesecond portion134 of theanchor130 to move with respect to thefirst portion132 of theanchor130. Similarly, theinsertion tool150 may be used to place thesecond anchor140 into the body of the patient.
• For example, in embodiments where theimplant110 is being placed in a pelvic region of a female patient, a vaginal incision may be made and theimplant110 may be placed into the body of the patient through the vaginal incision. In some embodiments, theinsertion tool150 may be used to guide theimplant110 into the vaginal incision and to the appropriate location within the body of the patient. In other embodiments, theimplant110 is inserted into the body of the patient through a different bodily incision and theanchors130 and140 are placed using a different type of insertion tool.
• Theimplant110, including thesupport member120, may be formed of any biocompatible material. In some embodiments, thesupport member120 is formed of a mesh material. For example, thesupport member120 may be formed of Advantage® mesh or the Polyform™ synthetic mesh, both as sold by Boston Scientific Corporation. In some embodiments, in thesupport member120 may be formed of a polymer material. In some embodiments, the material of thesupport member120 allows for tissue in-growth to secure theimplant100 to the bodily tissue of the patient. In some embodiments, the mesh weight can be approximately between 15 g/cm²to 35 g/cm²(e.g., 20 g/cm², 25 g/cm², 30 g/cm²). In other embodiments, the mesh weight can be greater than 35 g/cm².
• In some embodiments, thesupport member120 includes tangs to help retain the implant in place within the body of the patient. In such embodiments, the tang or tangs are configured to engage the bodily tissue surrounding thesupport member120 help retain theimplant100 in place within the body of the patient. The terms “tanged” or “tangs” as used herein mean roughened or jagged edges or areas, such as can result from cutting a woven or knit mesh material.
• Theanchors130 and140 may be formed of any biocompatible material. For example, in some embodiments, theanchors130 and140 are formed of polypropylene or a bio-absorbable material.
• FIG. 2 illustrates a medical device orsystem200 according to an embodiment. Themedical device200 includes animplant210 and aninsertion tool250. Theimplant210 has asupport member220. Thesupport member220 includes afirst end portion222 coupled to a first mesh carrier oranchor230 and asecond end portion224 coupled to a second mesh carrier oranchor240.
• Theimplant210 is configured to be placed within a body of a patient to provide support to a portion of the body of the patient. For example, in some embodiments, thesupport member220 of theimplant210 is configured to be placed proximate or adjacent a bladder of a patient to provide support to the bladder of the patient. In other embodiments, thesupport member220 of the implant is configured to support the urethera or bladder neck of a patient. In yet other embodiments, thesupport member220 of theimplant210 is configured to be placed adjacent another portion of the body to provide support to another portion of the body.
• The support member includesend portions222 and224. Theimplant210 also includes mesh carriers or anchors230 and240.Anchor230 is coupled to endportion222 andanchor240 is coupled to theend portion224. In some embodiments, theanchors230 and240 are directly coupled to theend portions222 and224 of thesupport member220. In the illustrated embodiment, a tether orsuture235 is coupled between theend portions222 and theanchors230. The tether orsuture235 is looped or threaded through thesupport member220 and is looped around and tied to theanchor230. Any other known mechanisms may be used to couple theanchors230 and240 to thesupport member220. For example, an adhesive may be used to couple theanchors230 and240 to thesupport member220. Alternatively, theend portions222 and224 may surround and be frictionally coupled to theanchors230 and240.
• Theanchor230 and240 are configured to be disposed in bodily tissue and provide a support forimplant210. Specifically, once disposed within bodily tissue, theanchors230 and240 are configured to help retain theimplant210 in place within a body of a patient. In some embodiments, theanchors230 and240 are configured to be disposed within pelvic tissue of a patient. In other embodiments, theanchors230 and240 are configured to be disposed in other bodily tissue, such as muscle tissue.
• In the illustrated embodiment, theanchor230 includes a barb orprojection231 disposed on or projecting from the first portion of theanchor232. Theanchor240 includes also includes a barb orprojection241 projecting from theanchor240. In other embodiments, theanchors230 and240 do not include any barbs or projections for securing theanchors230 and240 in place within the body of the patient.
• In the illustrated embodiment, theanchor230 includes afirst portion232 and asecond portion234.FIG. 3 is a perspective view of theanchor230.FIG. 4 is a side view of theanchor230.FIG. 5 is a perspective view of thefirst portion232 of theanchor230.FIG. 6 is a perspective view of thesecond portion234 of theanchor230. Thefirst end portion222 of thesupport member220 is coupled to thesecond portion234 of the anchor230 (as described above). Thesecond portion234 of theanchor230 is configured to move with respect to thefirst portion232 of theanchor230. In the illustrated embodiment, thesecond portion234 of theanchor230 moves with respect to thefirst portion232 of theanchor230 as a screw moves. Thesecond portion234 of theanchor230 includes a ridge (a helical ridge)237. Thefirst portion232 of theanchor230 defines alumen239. Thelumen239 is configured to receive thefirst portion232 of theanchor230 and has a sidewall that defines a groove (a helical groove)238. Thehelical groove238 is configured to receive thehelical ridge237 of thesecond portion234 of theanchor230. Thehelical groove238 and thehelical ridge237 interact to selectively move thesecond portion234 of theanchor230 with respect to thefirst portion232 of theanchor230. Specifically, thesecond portion234 of theanchor230 may be rotated with respect to thefirst portion232 of theanchor230 to move thesecond portion234 longitudinally with respect to thefirst portion232 of theanchor230.
• In the illustrated embodiment, aproximal end241 of thesecond portion234 of theanchor230 defines a recess orslot243. Therecess243 is configured to receive a portion of thedelivery tool250 to allow for the coupling or engaging of thedelivery tool250 with theanchor230 and to allow for the rotation of thesecond portion234 of theanchor230 with respect to thefirst portion232 of theanchor230. In the illustrated embodiment, therecess243 is star or “t” shaped. In other embodiments, therecess243 has a different shape.
• In some embodiments, theanchor230 may be disposed within the body of the patient. For example, the anchor may be placed within in bodily tissue such that the barb orprojection231 of theanchor230 engages body tissue to couple theanchor230 to the bodily tissue. The tension of the implant210 (or the location of the support member220) may then be adjusted by moving thesecond portion234 with respect to thefirst portion232 of theanchor230.
• In the illustrated embodiment, thesecond anchor240 is a one part anchor (or an anchor that does not include any portions that are configured to move with respect to each other). In other embodiments, thesecond anchor240 is a two part anchor and is structurally and functionally similar to thefirst anchor230.
• Theimplant210, including thesupport member220, may be formed of any biocompatible material. In some embodiments, thesupport member220 is formed of a mesh material. For example, thesupport member220 may be formed of Advantage® mesh or the Polyform™ synthetic mesh, both as sold by Boston Scientific Corporation. In some embodiments, in thesupport member220 may be formed of a polymer material. In some embodiments, the material of thesupport member220 allows for tissue in-growth to secure theimplant200 to the bodily tissue of the patient.
• In some embodiments, thesupport member220 includes tangs to help retain the implant in place within the body of the patient. In such embodiments, the tang or tangs are configured to engage the bodily tissue surrounding thesupport member220 help retain theimplant200 in place within the body of the patient. The terms “tanged” or “tangs” as used herein mean roughened or jagged edges or areas, such as can result from cutting a woven or knit mesh material.
• FIG. 7 is a top view of animplant310 according to another embodiment. Theimplant320 includes tangs orprojections348 that extend from thesupport member320 of the implant (such as the rough or jagged edges of a cut mesh material). In some embodiments, thetangs348 are configured to engage bodily tissue when theimplant310 is disposed within the body to help retain theimplant310 in place within the body of the patient.
• Thesupport member320 of theimplant310 includes atapered end portion322. Thetapered end portion322 is directly coupled to the anchor330. In the illustrated embodiment, the anchor330 extends through a portion of thetapered end portion322 to couple the anchor330 to thetapered end portion322. In other embodiments, thetapered end portion322 is coupled to the anchor330 via another mechanism, such an adhesive or other mechanism.
• Theinsertion tool250 of themedical device200 is configured to place theimplant210 into the body of the patient. For example, in some embodiments, theinsertion tool250 is configured to engage theimplant210 and guide the implant into position within the body of the patient.
• FIG. 8 is a side view of theinsertion tool250.FIG. 9 is a cross-sectional view of theinsertion tool250 taken along line9-9 ofFIG. 8.FIG. 10 is an end view of a distal tip of theinsertion tool250.FIG. 11 is an end view of the proximal end of theinsertion tool250.
• In the illustrated embodiment, theinsertion tool250 is configured to engage thesecond portion234 of theanchor230 to deliver or guide theanchor230 into place within the body of the patient. Theinsertion tool250 is configured to cause thesecond portion234 of theanchor230 to move with respect to thefirst portion232 of theanchor230. Theinsertion tool250 may be used to place thesecond anchor240 into the body of the patient.
• Theinsertion tool250 includes ahandle portion252 and aneedle portion254. Theneedle portion254 has atubular member256 and a shaft orstylet258. Thetubular member256 is coupled to thehandle portion252. Thestylet258 extends through a cavity or lumen defined by thetubular member256. Thestylet258 has a proximal portion261 that is disposed within thehandle portion252 and adistal portion263 that disposed distally of thetubular member256.
• Theneedle portion254 is sized and shaped to allow a user to position theimplant210 within the body of the patient. In the illustrated embodiment, theneedle portion254 includes a slight curvature. In other embodiments, theneedle portion254 includes a larger curvature. In yet other embodiments, theneedle portion254 is linear or substantially linear.
• Thestylet258 is configured to rotate along a longitudinal axis with respect to thetubular member256 and thehandle portion252. Thestylet258 is operatively coupled to anactuation member259 that is disposed within a window or opening257 defined by thehandle portion252 of theinsertion tool250. A user my grasp thehandle portion252 of theinsertion tool250 and move or rotate theactuation member259 to rotate thestylet258 with respect to thetubular member256.
• As best illustrated inFIG. 11, theactuation member259 is disposed below the outer surface of thehandle portion252 of theinsertion member250. In use, a user inserts a finger or a portion of a finger into the opening defined by thehandle portion252 of theinsertion tool250 to access and move theactuation member259 with respect to thehandle portion252. In some embodiments, this helps prevent unintentional movement of theactuation member259. In other embodiments, theactuation member259, or a portion of theactuation member259, extends above an outer surface of thehandle portion252.
• Thedistal tip263 of theinsertion tool250 is configured to engage theanchors230 and240 to place or push theanchors230 and240 into place within the body of the patient. Thedistal tip263 is “t” or star shaped. Thedistal tip263 is configured to mate with and engage therecess243 of theanchor230. In some embodiments, thedistal tip263 is sized and shaped to frictionally couple (or operatively couple) within therecess243 of theanchor230.
• When thedistal tip263 is engaged with therecess243 of theanchor230, the user of the insertion tool250 (such as a physician) may rotate theactuation member259 to rotate thestylet258 and cause thesecond portion234 of theanchor230 to rotate with respect to thefirst portion232 of theanchor230. As thesecond portion234 of theanchor230 rotates with respect to thefirst portion232 of theanchor230, thesecond portion234 of theanchor230 will move longitudinally with respect to thefirst portion232 of theanchor230.
• In embodiments where theimplant210 is being placed in a pelvic region of a female patient (for example, to be placed adjacent a bladder or bladder neck of a patient), a vaginal incision may be made and theimplant210 may be placed into the body of the patient through the vaginal incision. In some embodiments, theinsertion tool250 may be used to guide theimplant210 into the vaginal incision and to the appropriate location within the body of the patient.
• For example, theinsertion tool250 may be used to insert and place theanchor240 through the vaginal incision and into place within the body of the patient. Theinsertion tool250 may then be engaged with the anchor (by inserting the tip of theinsertion tool250 into the recess of the anchor230) and used to insert and place theanchor230 through the vaginal incision and into place with the body of the patient. Once theanchor230 is placed the support member may be placed below are proximate the portion of the body to be supported (such as a bladder or a urethera of a patient). To adjust the tension of thesupport member220 against the portion of the body to be supported, theinsertion tool250 can be used to move thesecond portion234 of theanchor230 with respect to thefirst portion232 of theanchor230. Specifically,actuation member259 may be rotated or moved by the user to move thesecond portion234 of theanchor230 with respect to the first portion of the anchor230 (as described in detail above). As thesupport member220 is coupled to thesecond portion234 of theanchor230, movement of thesecond portion234 of theanchor230 with respect to thefirst portion232 of theanchor230 will provide more tension (movement of thesecond portion234 towards the first portion232) or less tension (movement of thesecond portion234 away from the first portion232) on thesupport member220. In other words, the movement of thesecond portion234 with respect to thefirst portion232 causes the operating length of theimplant210 to change.
• FIG. 12 is a top view of animplant410 according to an embodiment. Theimplant410 has asupport member420. Thesupport member420 includes afirst end portion422 coupled to a first mesh carrier oranchor430 and asecond end portion424 coupled to a second mesh carrier oranchor440.
• Thefirst end portion422 is coupled to thefirst anchor430 via a suture ortether435. One end of the suture ortether435 is coupled to thefirst end portion422 of theimplant420. Any coupling method may be used to couple theend portion436 of the suture ortether435 to thefirst end portion422 of theimplant420. For example, the suture ortether435 may be tied or looped through a portion of thefirst end portion422. In other embodiments, an adhesive may be used to couple the suture ortether435 to thefirst end portion422.
• The suture ortether435 extends through anopening449 defined by theanchor430.FIG. 13 is a side view of theanchor430. Theopening449 defines an axis that is offset from the longitudinal axis (or disposed at an angle with respect to the longitudinal axis) of theanchor430. In the illustrated embodiment, the axis of the opening orlumen449 is disposed orthogonally or perpendicularly to the longitudinal axis of theanchor430. Theanchor430 includes afirst portion432 and asecond portion434. Thesecond portion434 of theanchor430 is configured to move with respect to thefirst portion432 of theanchor430. In the illustrated embodiment, thesecond portion434 of theanchor430 moves with respect to thefirst portion432 of theanchor430 as a screw moves. Thesecond portion434 of theanchor430 includes a ridge (a helical ridge)437. Thefirst portion432 of theanchor430 defines alumen439. Thelumen439 is configured to receive thefirst portion432 of theanchor430 and has a sidewall that defines a groove (a helical groove). The helical groove is configured to receive thehelical ridge437 of thesecond portion434 of theanchor430. The helical groove and thehelical ridge237 interact to selectively move thesecond portion434 of theanchor430 with respect to thefirst portion432 of theanchor430. Specifically, thesecond portion434 of theanchor430 may be rotated with respect to thefirst portion432 of theanchor430 to move thesecond portion434 longitudinally with respect to thefirst portion432 of theanchor430.
• In the illustrated embodiment, aproximal end441 of thesecond portion434 of theanchor430 defines a recess or slot. The recess is configured to receive a portion of a delivery tool (such as delivery tool250) to allow for the coupling or engaging of the delivery tool with theanchor430 and to allow for the rotation of thesecond portion434 of theanchor430 with respect to thefirst portion432 of theanchor430.
• Thesuture435 extends through theopening449 defined by theanchor430. In the illustrated embodiment, theopening449 is defined by thefirst portion432 of theanchor430. When thesecond portion434 of theanchor430 is in a first portion (as illustrated inFIG. 13), thesuture435 extends through theopening449 and may move within the opening. Accordingly, the length of the implant between theanchors430 and440 may be adjusted by pulling thesuture435 through theopening449 to a different location. Thesecond portion434 of theanchor430 may be moved to a second position (toward thefirst portion432 of the anchor430) to lock thesuture435 in place with respect to theanchor430. In the illustrated embodiment, thesecond portion434 of theanchor430 moves towards thefirst portion432 of theanchor430 to trap or frictionally engage or couple thesuture435 in place within theopening449.
• In use, theanchor440 may be placed within the body of the patient.Anchor430 may then be placed with thesecond portion434 of theanchor430 in its first position. Theimplant420 may be positioned under a bodily portion to be supported (such as the bladder or bladder neck). Thesuture435 may then be pulled or adjusted to move thesuture435 within theopening449 of theanchor440 and set the tension of theimplant410 and/or the length of theimplant410 between theanchors430 and440. Once the tension or length is set, thesecond portion434 of theanchor430 may be moved towards thefirst portion432 of theanchor430 to frictionally couple thesuture435 to theanchor430.
• In some embodiments, thesuture435 has a length sufficient to extend through theopening449 and out of the body of the patient when theanchor430 is placed within the body of the patient. For example, in some embodiments, thesuture435 has a length to extend from a vaginal incision of the patient when theanchor430 is disposed within the body of the patient.
• FIG. 14 illustrates theimplant210 disposed within a pelvic region of a female patient. Thesupport member220 is disposed adjacent a portion of a bladder B of the patient and theanchors230 and240 are disposed in pelvic tissue.
• FIG. 15 is a flow chart of a method500 according to an embodiment. The method includes at510 inserting a tissue anchor into a body of a patient. The tissue anchor includes a first portion and a second portion that is configured to move with respect to the first portion. At520, the second portion of the tissue anchor is adjusted with respect to the first portion of the tissue anchor. For example, in some embodiments, the second portion of the tissue anchor is rotated with respect to the first portion of the tissue anchor. In some embodiments, the rotation of the second portion of the tissue anchor with respect to the first portion of the tissue anchor includes engaging a shaft or a stylet with the second portion of the tissue anchor. In some embodiments, the shaft or stylet is engaged with the second portion of the tissue anchor by inserting a tip or end portion of the shaft or stylet into a recess or slot defined by the second portion of the tissue anchor.
• In some embodiments, the method500 includes inserting a second tissue anchor into the body of the patient. A sling or support member extends from the first tissue anchor to the second tissue anchor.
• In some embodiments, a medical device includes a tissue anchor having a first portion and a second portion. The tissue anchor is configured to be placed within bodily tissue of a patient. The first portion of the tissue anchor includes an extension member configured to engage the bodily tissue to help retain the tissue anchor within the bodily tissue. The first portion has an inner surface and defining a cavity. The second portion of the tissue anchor has a helical ridge. The helical ridge is configured to engage the inner surface of the first portion of the tissue anchor to movably couple the second portion of the tissue anchor to the first portion of the tissue anchor.
• In some embodiments, the extension member is a barb member. In some embodiments, the inner surface of the first portion defines a helical groove. The helical ridge of the second portion of the tissue anchor is configured to engage the helical groove of the inner surface of the second portion of the tissue anchor.
• In some embodiments, the medical device includes an implant coupled to the tissue anchor.
• In some embodiments, the tissue anchor is a first tissue anchor and the device further includes an implant having a first end portion and a second end portion opposite the first end portion. The first end portion is coupled to the first tissue anchor. The second end portion is coupled to a second tissue anchor. In some embodiments, the second portion of the tissue anchor is configured to rotate with respect to first portion of the tissue anchor. In some embodiments, the second portion of the tissue anchor includes an engagement portion configured to engage an insertion device. In some embodiments, the second portion of the tissue anchor includes a slot configured to engage an insertion device. In some embodiments, the first portion of the tissue anchor defines a longitudinal axis. The first portion of the tissue anchor defines a lumen defining a longitudinal axis. The longitudinal axis of the first portion of the tissue anchor is offset from the longitudinal axis of the lumen.
• In some embodiments, the first portion of the tissue anchor defines a longitudinal axis. The first portion of the tissue anchor defines a lumen defines a longitudinal axis. The longitudinal axis of the first portion of the tissue anchor is disposed at an angle with respect to the longitudinal axis of the lumen.
• In some embodiments, a medical device includes an elongate member having a proximal end portion and a distal end portion, a shaft member, and an actuator. The elongate member defines a cavity. The shaft member is at least partially disposed within the cavity of the elongate member. The shaft member is configured to rotate with respect to the elongate member. The actuator is operatively coupled to the shaft member and configured to cause the shaft member to rotate with respect to the elongate member.
• In some embodiments, a portion of the shaft member extends from the distal end portion of the elongate member. In some embodiments, a portion of the shaft member extends from the distal end portion of the elongate member and a portion of the actuator extends from a sidewall of the proximal end portion. In some embodiments, the actuator is configured to rotate with respect to the elongate member. In some embodiments, the actuator is configured to rotate with respect to the elongate member and at least a portion of the actuator extends from a sidewall of the proximal end portion. In some embodiments, the shaft member includes a tip that is configured to engage a tissue anchor.
• In some embodiments, a method of placing a medical device within a body of a patient includes inserting a tissue anchor into the body of the patient, the tissue anchor having a first portion and second portion; and adjusting the second portion of the tissue anchor with respect to the first portion of the tissue anchor.
• In some embodiments, the adjusting is a rotating and the rotating the second portion of the tissue anchor with respect to the first portion of the tissue anchor includes engaging the second portion of the tissue anchor with an insertion device that includes a shaft that is rotatably disposed within a cavity of an elongate member. In some embodiments, the rotating the second portion of the tissue anchor with respect to the first portion of the tissue anchor includes engaging a projection of a shaft of an insertion device with a slot defined by the second portion of the tissue anchor. In some embodiments, the tissue anchor is a first tissue anchor and the method further includes inserting a second tissue anchor into the body of the patient, the second tissue anchor being coupled to a sling member.
• While certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, changes and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the embodiments.

Claims (20)

What is claimed is:

1. A medical device, comprising:

a tissue anchor having a first portion and a second portion, the tissue anchor being configured to be placed within bodily tissue of a patient,

the first portion of the tissue anchor includes an extension member configured to engage the bodily tissue to help retain the tissue anchor within the bodily tissue, the first portion having an inner surface and defining a cavity,

the second portion of the tissue anchor having a helical ridge, the helical ridge being configured to engage the inner surface of the first portion of the tissue anchor to movably couple the second portion of the tissue anchor to the first portion of the tissue anchor.

2. The medical device ofclaim 1, wherein the extension member is a barb member.

3. The medical device ofclaim 1, wherein the inner surface of the first portion defines a helical groove, the helical ridge of the second portion of the tissue anchor being configured to engage the helical groove of the inner surface of the second portion of the tissue anchor.

4. The medical device ofclaim 1, further comprising:

an implant coupled to the tissue anchor.

5. The medical device ofclaim 1, the tissue anchor being a first tissue anchor, the device further comprising:

an implant having a first end portion and a second end portion opposite the first end portion, the first end portion being coupled to the first tissue anchor, the second end portion being coupled to a second tissue anchor.

6. The medical device ofclaim 1, wherein the second portion of the tissue anchor is configured to rotate with respect to first portion of the tissue anchor.

7. The medical device ofclaim 1, wherein the second portion of the tissue anchor includes an engagement portion configured to engage an insertion device.

8. The medical device ofclaim 1, wherein the second portion of the tissue anchor includes a slot configured to engage an insertion device.

9. The medical device ofclaim 1, wherein the first portion of the tissue anchor defines a longitudinal axis, the first portion of the tissue anchor defining a lumen defining a longitudinal axis, the longitudinal axis of the first portion of the tissue anchor being offset from the longitudinal axis of the lumen.

10. The medical device ofclaim 1, wherein the first portion of the tissue anchor defines a longitudinal axis, the first portion of the tissue anchor defining a lumen defining a longitudinal axis, the longitudinal axis of the first portion of the tissue anchor being disposed at an angle with respect to the longitudinal axis of the lumen.

11. A medical device comprising:

an elongate member having a proximal end portion and a distal end portion, the elongate member defining a cavity;

a shaft member at least partially disposed within the cavity of the elongate member, the shaft member being configured to rotate with respect to the elongate member; and

an actuator operatively coupled to the shaft member and configured to cause the shaft member to rotate with respect to the elongate member.

12. The medical device ofclaim 11, wherein a portion of the shaft member extends from the distal end portion of the elongate member.

13. The medical device ofclaim 11, wherein a portion of the shaft member extends from the distal end portion of the elongate member and a portion of the actuator extends from a sidewall of the proximal end portion.

14. The medical device ofclaim 11, wherein the actuator is configured to rotate with respect to the elongate member.

15. The medical device ofclaim 11, wherein the actuator is configured to rotate with respect to the elongate member and at least a portion of the actuator extends from a sidewall of the proximal end portion.

16. The medical device ofclaim 11, wherein the shaft member includes a tip that is configured to engage a tissue anchor.

17. A method of placing a medical device within a body of a patient, comprising:

inserting a tissue anchor into the body of the patient, the tissue anchor having a first portion and second portion; and

adjusting the second portion of the tissue anchor with respect to the first portion of the tissue anchor.

18. The method ofclaim 17, wherein the rotating the second portion of the tissue anchor with respect to the first portion of the tissue anchor includes engaging the second portion of the tissue anchor with an insertion device that includes a shaft that is rotatably disposed within a cavity of an elongate member.

19. The method ofclaim 17, wherein the rotating the second portion of the tissue anchor with respect to the first portion of the tissue anchor includes engaging a projection of a shaft of an insertion device with a slot defined by the second portion of the tissue anchor.

20. The method ofclaim 17, the tissue anchor being a first tissue anchor, the method further comprising:

inserting a second tissue anchor into the body of the patient, the second tissue anchor being coupled to a sling member.

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