Medical devices and implant assemblies for implant capture

This invention generally relates to devices and methods that allow an operator to position an implant into the body of a patient without the need for direct-vision of the operator or the need to hand-guide a needle in order to capture an implant. In one aspect, a multi-arm delivery device includes a receiving arm that releasably holds an implant in place for capture and a clamping arm that includes a needle deployment mechanism for advancing a needle directly to the implant for capture and for retracting the needle with the implant attached to deliver the implant into the desired location. In one embodiment, the needle includes a plurality of retaining slots. In another embodiment, an end portion of the implant is configured to receive a needle into the end portion and at least some of the end portion of the implant is configured to be retained into one or more retaining slots of the needle.

TECHNICAL FIELD

This invention generally relates to implants and medical devices that are configured to position implants within the body of a patient.

BACKGROUND

Urinary incontinence, or loss of bladder control, is a condition that causes people to involuntarily leak urine while coughing, sneezing, laughing, and exercising. Men and women both suffer from incontinence. Almost 16 percent of the women population suffers from urinary incontinence, and men account for a quarter the total patient population.

Typically, urinary incontinence is treated by placing a supportive implant, often called a sling, into the pelvic region of a patient. The supportive implant is used to cradle or support the bladder or urethra, depending on the procedure. Supportive implants are delivered to the pelvic region through one or more vaginal incisions and/or through exterior incisions in body of the patient. In addition to urinary incontinence, supportive implants placed into the pelvic region can also be used to correct various pelvic prolapse conditions, which include uterine prolapse, rectocele, cystocele, and urethrocele.

The common procedure for delivering such implants into the pelvic region of the patient involves a delivery tool that has a long curved shaft with a hooked needle tip attached to a handle. A surgeon maneuvers by hand the delivery tool into and within the pelvic region through and/or around tissue where the implant is desired to be placed. Once positioned, the surgeon must further manipulate the delivery tool by hand to capture an implant attached to a looped end onto the hooked needle tip. In some instances, the surgeon may require an additional tool to grasp the implant and place the implant onto the hooked needle tip. After which, the surgeon withdraws the delivery tool to position the implant in the desired location.

The above procedure is limited because it requires direct vision of the surgeon to capture the implant in sometime hard to access regions of the pelvic. In addition, the delivery tool is hard to control by hand, and often the delivery tool deviates from the desired path of implantation. This deviation can result in failed attempts to capture the implant and to improper placement of the implant. Moreover, deviation of the delivery tool can result in inadvertent tissue, nerve, bladder, or urethral damage, and any required additional attempts at implant delivery significantly increase the risk of such tissue and/or nerve damage.

SUMMARY

Devices and methods of the invention allow an operator to position an implant into the body of a patient without the need for direct-vision of the operator or the need to hand-guide a needle in order to capture an implant. The invention includes multi-arm delivery devices, implants and implants assemblies, and methods for blind-capture of the implants with the multi arm delivery device. In one aspect, the multi-arm delivery device includes a receiving arm that releasably holds an implant in place for capture and a clamping arm that includes a needle deployment mechanism for advancing a needle directly to the releasably-held implant for capture and for retracting the needle with the implant attached to deliver the implant into the desired location. Because the multiarm delivery device does not require the operator to hand guide the needle, the device significantly lessens inadvertent tissue damaged caused by needle deviation. In addition, the multi-arm delivery device advantageously allows one to pre-position the implant into the body. Once pre-positioned, the device guides the needle through the desired implantation location directly to the implant for capture, and then the pulls the implant to the desired location. This diminishes the risk of improper placement of the implant and increases successful capture events.

In addition, the inventors realized that the needle path may minutely deviate despite being directed by the multi-arm delivery device due to the densely-packed tissue in the pelvic region. Such minute deviations are not likely to cause damage, but the deviations may result in a failure to capture the implant. For example, if the implant is attached to a single suture loop and the needle includes one retaining slot, the needle deployment mechanism must precisely position the needle so that the single suture loop is placed into the retaining slot of the needle. If the needle path deviates so that the needle goes slightly under or below the suture loop, the suture loop may not be placed in the needle retaining slot.

To account for such minute deviations in the needle path and to prevent any potential failed implant capture, the invention provides for use of needles with multiple retaining slots and/or implant assemblies including multiple capture portions. The combination of the multi-arm delivery with the needle having multiple retaining slots and/or implant assemblies with multiple capture portions significantly expands the acceptable range of the delivery path of the needle and increases the probability that the implant will be captured by the needle. This provides for implant capture regardless of slight deviation of the needle.

According to certain aspects, a multi-arm delivery device includes a first portion and a second portion coupled to the first portion. The first portion of the delivery device includes a handle, a junction section, and a needle-receiving arm extending distally from the junction section. A distal portion of the needle receiving-arm is configured to releasably-hold an end portion of an implant. The distal portion defines an opening that leads to a cavity for receiving a needle comprising a plurality of retaining slots. The implant end portion is releasably held within the cavity. The second portion of the multi-arm delivery device includes a clamping arm movably coupled to the junction section of the first portion. The clamping arm allows an operator of the delivery device to hold the handle and move the clamping arm with respect to the first portion. In one embodiment, the clamping arm is curved. The clamping arm includes a needle deployment mechanism for advancing the needle comprising a plurality of retaining slots through tissue of the body of the patient and into the cavity of the distal portion of the needle-receiving arm. The needle deployment mechanism is configured to direct the needle towards the receiving arm. As the needle is advanced into the cavity, at least a portion of the implant end portion is placed into at least one of the plurality of needle retaining slots. The needle deployment mechanism also retracts the advanced needle out of the cavity and back through the tissue to pull the end portion of the implant through tissue for positioning.

Embodiments according to this aspect of the invention can include various features. In one embodiment, the needle deployment mechanism of the clamping arm has a distal end and a proximal end and includes a sliding component coupled to the needle. The sliding component can be slideably disposed on a guide rail such that movement of the sliding component in the distal direction along the guide rail advances the needle to the receiving arm and movement of the sliding component in the proximal direction along the guide rail retracts the needle. The guide rail can be straight or curved. In an embodiment, the guide rail conforms to the shape or curvature of at least a portion of the clamping arm. The needle can include one or more retaining slots. The retaining slots can be located on the distal end of the needle and configured to capture the end portion of the implant when the needle retracts from the cavity of the needle-receiving arm. The retaining slots can be arranged around the same cross-section of the needle, spirally-aligned on the needle, located distal to one and other, or arranged in any other orientation. In addition, the needle can be straight or curved. For example, the needle can conform to the shape or curvature of the at least a portion of the clamping arm or at least a portion of the guide rail. The implant end portion can include a mesh catch for receiving the needle. The mesh catch may include a plurality of openings. Each of the plurality of openings of the mesh catch can be defined by at least one flexible edge configured to move. During capture, at least one of the flexible edges moves as the needle advances into one of the plurality of openings of the mesh catch, and this at least one of the flexible edge moves into at least one retaining slot as the needle is retracted. The mesh catch can be formed as part of the implant or coupled to the implant via a suture. The implant end portion can include a bundled catch for receiving the needle. The bundled catch can define a volume. The bundled catch can comprise a plurality of flexible members spherically disposed between two suture arms for receiving a needle. Alternatively, the bundled catch can comprise a plurality of looped members for receiving the needle, or the bundled catch can be a netted or threaded ball. The bundle catch can be coupled to at least one suture arm. During capture with the bundle catch, at least a portion of the advancing needle enters into the bundled catch, and a portion of the bundle catch is configured to enter one or more retaining slots as the advanced needle retracts.

Although the multi-arm delivery device is suitable for delivering any type of implant, in certain aspects, the implant is a sling for implantation into the body of the patient to treat urinary incontinence by raising or supporting the patient's bladder neck. The implant may also be a mesh implant used to correct various pelvic prolapse conditions, which include uterine prolapse, rectocele, cystocele, and urethrocele. The implant also includes an end portion (also referred to herein as the capture portion) for receiving a needle. The capture portion of the implant can be formed as part of the implant or can be coupled to or attached to the implant. For example, the capture portion can be coupled to the implant via a connecting element (e.g. a suture). Because certain embodiments of the implant include a sling and a capture portion, the implant is also referred to as an implant assembly. In some embodiments, the capture portion is detachable from the sling after the sling is positioned within the body of the patient. In certain embodiments, the implant is contained within a packaging, and the end portion or capture portion extends from the packaging. In another aspect, the invention relates to an implant assembly for treating urinary incontinence in a patient. The implant assembly includes a sling configured for implantation into the body of the patient the patient for raising or supporting the patient's bladder, bladder neck or urethra, and a capture portion coupled to the sling and configured to receive at least portion of a needle comprising one or more retaining slots into the capture portion. At least a part of the capture portion configured to be retained in the one or more retaining slots to allow the needle to position the sling into the body of the patient. Embodiments according to this other aspect of the invention also can include various features. In certain embodiments, the capture portion of an implant assembly is coupled to a suture that attaches the capture portion to a sling. The suture can directly attach to the capture portion, or the suture can include two or more suture arms that attach to the capture portion. The suture and/or suture arms assist in positioning and releasably holding the capture portion in the cavity of the receiving arm. For example, the distal end of the receiving arm can have one or more slits, and the suture or suture arms are positioned within the slits to place the capture portion within the cavity.

In certain embodiments, the capture portion is a mesh catch comprising a plurality of openings for receiving the advanced needle. Each of the plurality of mesh openings can be defined by at least one flexible edge of the mesh catch. As the needle passes into one of the plurality of openings in the mesh catch, at least one of the flexible edges of this opening moves to receive the needle and then moves again into a retaining slot of the needle. When the needle retracts, the flexible edge remains in the retaining slot, and the needle pulls the implant into the desired position in the body. In other embodiments, the capture portion is a bundled catch that is configured to receive at least a portion of the needle into the bundle catch and at least a portion of the bundled catch is configured to enter one or more retaining slots of the needle. The bundle catch can be a three-dimensional catch defining a volume that includes a plurality of capture members. The plurality of capture members increase the likelihood that a portion of the bundle catch will enter and be retained in one or more retaining slots of a needle. In one embodiment, the bundle catch is a plurality of looped members. In another embodiment, the bundle catch is a threaded or netted ball. In yet another embodiment, the bundled catch is a plurality of flexible members spherically disposed between two suture arms.

Other and further aspects and features of the invention will be evident from the following detailed description and accompanying drawings, which are intended to illustrate, not limit, the invention.

DETAILED DESCRIPTION

The invention relates to multi-arm delivery devices, implants and implant assemblies, and method of using the device for inserting and placing implants or implant assemblies within a body of the patient. The multi-arm tool is suitable for delivering implants into any portion of the body. Particularly, the multi-arm delivery device is for inserting and placing supportive implants into the pelvic region of a patient. Once the multi-arm delivery device places an implant into the desired location within the pelvic region of the patient, the implant can be secured to the pelvic wall or surrounding tissue to provide required support for treatment.

Typically, the supportive implants are positioned with the multi-tool delivery device for the treatment of urological disorders, such as stress incontinence, urge incontinence, mixed incontinence, overflow incontinence, prolapse (e.g. vaginal), enteroceles (e.g. of the uterus), rectoceles and other non-urological disorders, are also included within the scope of the present invention. The multi-arm delivery device is also suitable for delivering implants in procedures to treat, for example, cystocele prolapse, other types of vaginal prolapse and anatomic hypermobility.

Various embodiments of the multi-arm delivery device, methods of use, and implants assemblies for use with the multi-arm delivery device are described hereinafter. The various implant assemblies can be used in combination with any one of the embodiments of the multi-arm delivery device without limitation. In addition to use in combination with the multi-arm delivery device of the invention, the implant assemblies and implants may also be used in conjunction with any other implant delivery devices.

FIG. 1depicts an embodiment of the multi-arm delivery device100. The multi-arm delivery device100includes a clamping arm10and a receiving arm15. The receiving arm15extends distally from a junction section25which extends distally from a handle20. The clamping arm10is movably coupled to the junction section25. In addition, the receiving arm25can be movably coupled to the junction section25. The clamping arm15typically has an L-like shape or T-like shape, and a portion of the clamping arm10can be curved or straight. The clamping arm10, as shown inFIG. 1, includes a curved portion. The curvature of the clamping arm10is designed to deliver the needle directly into a cavity of the distal end of the receiving arm15.

The junction section25, as shown inFIG. 1, includes a finger hole30that can be used to grasp the delivery device100along with the handle20. The junction section25also operates as a hinge to allow movement of the clamping arm10with respect to the receiving arm15, or vice versa. The clamping arm10is rotatably movable in the direction O1and/or the direction O2with respect to the receiving arm15. Alternatively, the receiving arm15is rotatably movable in the direction O1and/or the direction O2with respect to the clamping arm10.

FIG. 4shows the multi-arm delivery device in an open configuration with the clamping10moved away from the receiving arm15.FIG. 5shows the clamping arm10in a completely clamped configuration, i.e. moved all the way towards the receiving arm15in the O1direction.FIG. 2shows the clamping arm10is a partially clamped configuration. The desired clamped configuration for a procedure will depend on the amount of tissue between the receiving arm15and clamping arm10and the type of procedure.

The multi-arm delivery device100as shown inFIGS. 1-5includes inner guide80. The inner guide80is an optional element that is fixed to junction section25and disposed within the clamping arm10. The inner guide80can be used as an additional gripping element for the operator, and acts to stabilize and direct the clamping arm towards the receiving arm. The clamping arm10slideably moves over the inner guide10in the O1direction and O2direction. When the device is in the open configuration as shown inFIG. 4, the inner guide80is shown in the open space between the clamping arm10and the receiving arm15.FIGS. 2 and 3show the clamping arm10in a partially clamped position in which the inner guide117is completely disposed within the clamping arm10.FIG. 4shows the clamping arm10in a fully clamped position with the inner guide extending behind the clamping arm10.

The clamping arm10includes one or more side tabs85along the side of the clamping arm10. The side tabs85include a smooth portion85aand rough portion85b. The side tabs85are best shown inFIG. 3, which provides an angled view of multi-arm delivery device100. The side tabs85can be used by an operator to push (e.g. using a thumb) the clamping arm10towards the receiving arm15in the O1direction. The side tabs85can also be pulled on by an operator to move the clamping arm in the O2direction. The side tabs85can be used to hold the device100in a clamped configuration. For example, the operator can hold the device100in a clamped configuration prior to operating the needle deployment mechanism of the clamping arm, which is described more detail below. The smooth portion85ais configured so that a thumb of an operator can slide along the smooth portion85ato move the clamping arm10towards the receiving arm15. The rough portion85bis configured to stop the sliding of the operator's thumb and the rough portion85bacts as a grip. The rough portion85bcan have any suitable friction-based surface, such as a rough adhesive surface, sandpaper-type surface or a bumpy surface. As shown inFIGS. 1-5, the clamping arm10also includes one or more finger tabs75that can also be used by an operator to push the clamping arm10in the O1direction and pull the clamping arm in the O2direction. The finger tabs75can include any shape suitable for pushing and pulling the clamping arm10. As shown, the finger tabs75have a rough surface for pushing and the finger tabs form an finger hole in the clamping arm10that allows an operator to insert a finger to pull the clamping arm10.

In certain aspects, the multi-arm delivery device100includes a biasing mechanism such as a spring, ratchet or gear that biases the clamping arm10, for example, in the open configuration shown inFIG. 4or the clamped configurationFIG. 5. The biasing mechanism automatically moves the clamping arm10towards the biased position upon removal of operator applied force. In some aspects, medical device100can include a locking element on the clamping arm10that locks the clamping arm in a specific position. The clamping arm10of the medical device100can be configured to be fixed at any location along the direction O1by the locking mechanism. The locking mechanism can include a ratchet mechanism.

The distal end of the clamping arm10, as shown inFIG. 1, includes a needle deployment mechanism that includes a proximal portion50and a distal portion52. The needle deployment mechanism is used to advance the needle40through tissue towards the receiving arm15to capture an implant165, and is also used to retract the needle40back through the tissue while pulling the captured implant165into position.

The needle deployment mechanism includes a sliding component55and a guide rail60. The guide rail60can be curved or straight, but is shown inFIGS. 1-5as curved. In some embodiments, the shapes of the guide rail60and the needle40are dependent on the curvature or shape of the clamping arm10. The guide rail60includes a groove61(shown inFIG. 3) that allows the sliding component55to slidably move within the groove61in direction P1and in direction P2. The sliding component55is operably coupled to the needle40, and movement of the sliding component55allows for the needle to be advanced and refracted. As the sliding component moves in direction P1, the needle is advanced towards the receiving arm15.FIGS. 3 and 4show the sliding component moved towards the distal portion of the needle deployment mechanism52with the needle40advanced halfway across an open space between the receiving arm15and clamping arm10. During a procedure, the needle40would pass through or around tissue disposed within the open space.

The sliding component55includes a grip90that allows the operator to push and pull the sliding component along the guide rail60in order to deploy and retract the needle. The grip90can be made in any shape or size that is convenient to the operator. As shown inFIGS. 1-5, the grip90is a tab structure. Alternatively, the grip90can made into a handle or configured to receive and retain a detachable handle. In one aspect, the grip is configured to receive and attach to a syringe, and the syringe can be used to move the sliding component55and deliver drugs through the needle and into tissue of the patient while the needle is advanced and retracted through tissue. In such embodiment, the needle40defines a lumen for transmitting the drug delivered into the needle by the syringe.

In certain aspects, the needle deployment mechanism includes a biasing mechanism that causes the sliding component55to be biased to the stowed configurations (i.e. when the needle is retracted) as shown inFIGS. 1, 4 and 5, or alternatively, in a deployed configuration (i.e. when the needle is advanced) as shown inFIGS. 2 and 3. Although not shown, the biasing mechanism can be a spring disposed within the groove61of the guide rail60. When force is no longer applied to the sliding component in the P1direction, the spring automatically pushes the sliding component in the P2direction towards the proximal portion of the needle deployment mechanism50. In some embodiments, the needle deployment mechanism can include at least one of a piston, a spring, an actuator, and the like mechanism to make the sliding component55movable.

The sliding component55can move independently from the clamping arm10, and the clamping arm10can move independently from the sliding component55. For example, during a procedure, the operator can, without moving the sliding component, clamp down the tissue through which the implant will be placed by moving the clamping arm in the O1direction towards the receiving arm with the tissue disposed between the arms. With the tissue clamped and the clamping arm held in the clamped position, the operator can then move the sliding component in the P1direction towards the receiving arm15to capture the implant165.

As shown in at leastFIG. 1, a guide compartment70is disposed on the distal portion52of the needle deployment mechanism. The guide compartment70defines at least one lumen115through which the needle40passes during deployment and retraction. As shown inFIG. 1-5, the guide compartment includes two sections and defines two lumens.FIGS. 8a-8cshow a guide compartment70with only one section that defines one lumen. The guide compartment70also houses or stows the needle40prior to deployment, as shown inFIGS. 1, 4and5. The guide compartment70acts to direct the advancing needle40with little to no deviation towards the receiving arm15.

The receiving arm15is configured to releasably hold a capture portion55of an implant assembly (i.e. the end portion of an implant) in the distal end35of the receiving arm15. The distal end35of the receiving arm15is best shown inFIGS. 13cand 15c. As shown inFIG. 13c, the distal end35of the receiving arm15includes an opening237leading to a cavity240. The distal end35of the receiving arm contains one or more slits145for releasably holding the capture portion within the cavity240. InFIG. 13c, the distal end35includes two slits145for releasably holding a mesh capture portion185that is coupled to two arms of a suture205. InFIG. 15c, the distal end35includes one slit145for releasably holding a bundled capture portion400that is directly coupled to a suture205.

Although the needle40, as shown inFIGS. 1-5, includes a single retaining slot215located on the distal end45of the needle40, in preferred aspects of the invention, the needle includes a plurality of retaining slots215. The needles40with a plurality of retaining slots are shown inFIGS. 12a-12dand are described hereinafter.

In an embodiment, the medical device100, can be made of ultra violet (UV) cured epoxy resin. In some embodiments, the UV cured epoxy resin can be fabricated by Stereo Lithography Apparatus (SLA). In some embodiments, various components of the medical device100can be made of any plastic or metal (such as polycarbonate or 304 stainless steel) materials. Other embodiments may include use of manufacturing methods including but not limited to molding or machining components and materials including but not limited to metals, polymers and ceramics.

The multi-arm delivery device can be used to place supportive implants into the various positions within pelvic region for treatment of incontinence and to correct various pelvic prolapse conditions such as uterine prolapse, rectocele, cystocele, and urethrocele.

The supportive implants, typically called slings, include posterior support implants, anterior support implants, and or total pelvic floor repair implants. The implants are used to treat a variety of pelvic dysfunctions and can be placed and secured at various locations within the pelvic space for treatment. For example, an implant can be secured to a sacrospinous ligament or an ureterosacral ligament for posterior support or for uterine preservation. A uterine preservation procedure is performed, instead of a hysterectomy, when the prolapsed uterus is otherwise healthy and can maintain normal function if re-suspended by an implant. Posterior support is used to treat posterior vaginal wall prolapse, also called “rectocele,” that is caused by a weakening of the wall between the vagina and the rectum. Implants can also be placed for securing the implant to the pubo-urethral tissue or an obturator muscle (e.g. internus or externus) and/or obturator membrane to treat, for example, incontinence. An implant can also be secured to a sacrospinous ligament or an arcus tendineus fascia pelvis (also known as “arcus tendineus) for paravaginal repairs. Paravaginal repairs include cystoceles, rectoceles, and enteroceles.

Patients that undergo implant procedures include both male and female patients. A patient may have one or multiple implants inserted at a time. For example, an implant procedure may include securing an implant to the sacrospinus ligament and securing an implant to the pubo-urethal tissue.

Because different procedures and different treatments require different implant positions, the multi-arm delivery device provides for implant delivery through a variety of incisions sites into the body. For example, the multi-arm delivery device can be used to position an implant through a vaginal incision, in a retro-pubic direction (i.e. behind the pubic bone), in a pre-pubic direction (i.e. in front of the pubic bone), or in a supra-pubic direction (above the pubic bone). The multi-arm delivery device can also be used to places an implant through or around any anatomical tissues or ligaments disposed within the pelvic region. Types of vaginal incisions through which the multiarm delivery tool place implants include anterior vaginal incisions and/or posterior vaginal incisions. In addition, the multi-arm delivery tool can also be used to deliver implants through an exterior incision.

FIGS. 6a-6cdepict the various implant locations that the multi-arm delivery device100can be used for positioning or delivering the implant to the location. The various implant locations illustrated inFIGS. 6a-6bare not exhaustive, but rather shown to exemplify some of the many positions that the multi-arm delivery device100can place implants.

FIG. 6aillustrates an implant positioned between a portion of a vagina V of a patient and a portion of a bladder BL of the patient so that the implant provides support to the bladder BL of the patient.

FIG. 6billustrates an implant A positioned into the body so that the implant A extends through the patient's obturator foramens OF. In addition,FIG. 6billustrates an implant B positioned between the midline incision, the Ischiocavernosus muscle IC, and in front of the pubic bone. In order to position implant B, the multi-arm delivery device would enter the pelvic region from a pre-pubic direction. Although not shown, Implant B can also be extended between the arcus tendineus facia pelvis (ATFP) and the obturators OF.FIG. 6balso illustrates implant C positioned in a “V” shape under the bladder and in front of the Ischiocavernosus muscle IC.

FIG. 6cillustrates an implant positioned so that the implant extends towards the obturator foramens OF but does not extend through the obturator foramens OF. In this position, the implant may be disposed within or coupled to muscles that are proximate to the obturator foramens OF.

FIG. 7shows an embodiment of the multi-arm delivery device200in use within the body of a patient. As shown inFIG. 7, at least a portion of the receiving arm15is disposed within the vaginal region120of the patient. The clamping arm10is pressed against the tissue122between the receiving arm15and the clamping arm10. The guide compartment70is pressed against the obturator foramens95of the patient. The sliding component55is deployed in the F1direction so that at least a portion of the needle40is pushed through the lumen115of the guide compartment70and into the tissue122. The multi-arm delivery device200includes a locking mechanism105. The locking mechanism105rotatably couples to the receiving arm15and engages with the clamping arm10. The locking mechanism105includes a finger tab110, which may be used to adjust the locking mechanism105. The locking mechanism105may include a ratchet mechanism.

FIGS. 8a-8cillustrate the multi-arm delivery device200in various positions of operation. As shown inFIG. 8a, the multi-arm delivery device200includes a receiving arm15and a clamping arm10rotatably coupled to receiving arm at junction25. The junction25includes a hinge H (e.g. coupled via a pin, screw, etc.) that allows the clamping arm10and the receiving arm15to rotate towards and away from each other in the C1and C2directions. The clamping arm has a T-like shape, and a needle deployment mechanism is disposed on a slightly-curved portion of the clamping arm10(cross-bar of the T). The needle deployment mechanism includes a guide rail60, needle40, a sliding component55that are curved to conform to the curved portion of the clamping arm10. In other embodiments, the portion of the clamping arm10that holds the needle deployment mechanism, the guide rail60, the needle40and the sliding component55are straight, curved, or a combination of both.

The guide rail60of multi-arm delivery device200is shown in greater detail inFIG. 9.FIG. 9is the cross-sectional view of the Z-section fromFIG. 8a.FIG. 9shows a cross-sectional view of the sliding component55on the guide rail60. In this embodiment, the sliding component55includes sliding members155that wrap at least partially around the guide rail60so that the sliding component55remains securely on the guide rail60during operation. The guide rail60has a top surface160along which the sliding component55can slidably move. The top surface160can be a curved surface and/or a flat surface. A portion of the needle is disposed within or coupled to the sliding component55.

The distal end35of the receiving arm15is configured to releasably hold an implant165, which is part of an implant assembly. The implant assembly includes the implant, i.e. sling,165, and a capture portion150coupled to or formed as part of the implant165. The capture portion150is also referred to the end portion of the implant165.

The following describes the operational positions of the multi-arm delivery device200as shown inFIGS. 8a-8b.

FIG. 8adepicts the multi-arm delivery device200with the clamping arm10and receiving arm15in open configuration having the needle40in a retracted position. When the needle40is in this position, the distal end45of the needle40is stowed or held within the lumen115of the guide compartment70.

FIG. 8bdepicts the multi-arm delivery device200having the clamping arm10and receiving arm15in a partially clamped position. In operation, tissue and/or a ligament may be placed in the space S between the clamping10arm and receiving arm15. The sliding component moved in the C1direction so that the needle40is advanced across the space S and into the distal end35of the receiving arm15where the capture portion55of the implant is releasably held. Within Section Y, the needle40captures the end portion of the implant55. The capture event that occurs in Section Y is shown inFIGS. 13c-13e, 14c-14e, 15c-15eand described in the corresponded text.

FIG. 8cdepicts the needle40retracting out of the distal end35of the receiving arm15as the sliding component55is moved in the D2direction. As shown, the needle40has the capture portion55of the implant165disposed within the retaining slot215of the needle40. As the needle40retracts, the needle pulls at least a portion of the implant165along the path of the needle40across space S. The retraction of the needle with the captured implant allows the operator of the device200position the implant into the desired location. If the needle penetrated tissue, the retraction of the needle allows the operator to position the implant165substantially along the needle path through tissue. If the needle does not penetrate tissue, it allows the operator to position the sling around tissue, ligaments, etc. disposed within the space S between the receiving arm15and clamping arm10. Both movement of the sliding component in the D2direction and movement of the clamping arm in the C2direction can cause the needle40to retract out of the distal portion35of the receiving arm15.

In certain aspects, the multi-arm delivery device utilizes a needle40that includes a plurality of retaining slots215and pointed tip120at the distal end of the needle40. In certain embodiments, the pointed tip120is a tissue penetrating tip. In some embodiments, pointed tip120may include multiple facets or edges. Each retaining slot215defines a recess within the body of the needle40and includes an angled inner wall designed to hook/retain at least some of the capture portion during retraction of the needle40. The plurality of retaining slots215provides for a higher capture probability because the plurality of retaining slots215increases the surface area of the needle that is capable of retaining at least some of the capture portion55. Any configuration of retaining slots215is suitable for use in the invention. For example, the retaining slots215can be placed in an organized fashion around the needle40or placed randomly on the needle40. For example, needle40can have two retaining slots215disposed on the same cross-section, three retaining slots215disposed on the same cross section, two retaining slots215in a row on the top of the needle, two retaining slots215in a row on the bottom of the needle, etc.

FIGS. 12a-12dexemplify various embodiments of a needle40with a plurality of retaining slots215.FIG. 12ashows a needle40having a top retaining slot215and a bottom retaining slot215.FIG. 12bshows a needle40having a first side retaining slot215and a second side retaining slot215.FIG. 12cillustrates a needle40with four retaining slots215, which includes a first set of two retaining slots near the needle tip120and a second set of two retaining slots proximal to the first set. The retaining slots215of each set are open in the opposite direction. As shown inFIG. 12c, one set of retaining slots215defines recesses that are open on the side of the needle body, and the other more proximal set of retaining slots215defines recesses that are open from the top and bottom of the needle body.FIG. 12dillustrates four retaining slots215in a spiral formation around the needle40.

The implants, or slings,165for use with the multi-arm delivery devices can include a wide variety of shapes and sizes, materials and treatments. While the sling165is preferably rectangular for treating incontinence, other shapes are also contemplated. Depending on the treatment addressed (e.g. to provide hammock support for the bladder or bladder neck, or to address a rectocele, enterocele or prolapse) the sling may be any of a wide variety of shapes. As an example, the sling may be of the general shape of the slings described and shown in Moir et al., The Gauze-Hammock Operation, Journal of Obstetrics and Gynaecology of the British Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968).FIG. 10illustrates a rectangular sling65suitable for use in the invention.

The sling165can also be formed in a protective sheath170which surrounds the sling165, as shown inFIG. 11. The protective sheath170is used to facilitate delivery of the sling165without friction against the body tissue, ligaments, organs, etc. Once the sling165is placed into the desired position, the protective sheath170is typically removed. In some embodiments, the sheath170extends along substantially the full length of the implant. In some embodiments, the sheath may extend along only a portion of the length of the implant. In some embodiments, more than one sheath is utilized. As an alternative to the protective sheath, any other packaging can be used, such as a sleeve.

In certain embodiments, sheath170and the implant165are made of materials having sufficient strength and structural integrity to withstand the various forces exerted upon these components during an implant delivery procedure and/or following implantation within a patient.

In one embodiment, the sling165is made of a mesh material. The mesh material comprises one or more woven or inter-linked filaments or fibers that form multiple fiber junctions throughout the mesh. The fiber junctions may be formed via weaving, bonding, ultrasonic welding or other junction forming techniques, including combinations thereof. In addition, the size of the resultant openings or pores of the mesh should be sufficient to allow tissue in-growth and fixation within surrounding tissue. As an example, not intended to be limiting, the holes may comprise polygonal shaped holes with diagonals of 0.132 inches and 0.076 inches. The quantity and type of fiber junctions, fiber weave, pattern, and material type influence various sling properties or characteristics. In some embodiments, the mesh material comprises the least amount of material necessary to perform its function. Less material may promote quicker ingrowth of tissue through the mesh and may promote better securement at the implantation site.

There are many suitable mesh materials, and the implant may, in the alternative or in combination, be made of non-mesh materials. Exemplary mesh materials include, for example, synthetic materials, natural materials (e.g., biological) or a combination thereof. The mesh may be fabricated from any of a number of biocompatible materials, such as nylon, silicone, polyethylene, polyester, polyethylene, polyimide, polyurethane, polypropylene, fluoropolymers, copolymers thereof, combinations thereof, or other suitable synthetic material(s). The material may be, for example, a biodegradable synthetic material. The term “biodegradable,” as used herein, refers to the property of a material that dissolves in the body. Such materials may also be absorbed into the body, i.e., bioabsorbable.

In some aspects, the ends of the implant165or the ends of the protective sheath170having an implant165disposed therein are attached to capture portions55to form an implant assembly. Typically, the capture portions55are attached to the implant165or to the protective sheath170via a suture or other connecting element. It is also contemplated that the implant165or sheath170may have any number of ends, and the capture portion may be coupled to one end, a few of the ends, or all of the ends. In another embodiment, the implant165and protective sheath170are not coupled to the capture portion55, but rather the capture portion55is formed as part of the implant165or sheath170(i.e. the capture portion is the actual end portion of the implant or sheath).

Various embodiments of implant assemblies are shownFIGS. 13a, 14a, and 15a. As shown inFIGS. 13a, 14a, and 15a, each implant assembly includes an implant or sling165that are coupled to attachment members180. A suture205, or other cord-like member, is coupled to the attachment member180and extends to a capture portion55(shown as185inFIG. 13a,200inFIG. 14a, and400in15a). The suture205may be coupled to the capture portion in any suitable manner to allow the capture portion to be releasably-held within receiving arm15. As best shown inFIG. 14b, the suture205can be split into two separate arms207then coupled to the sides of the capture portion200. Alternatively, the suture205can be directly attached to the capture portion400, as shown inFIGS. 15a-15d.

In certain aspects, the capture portion55, as used with the multi-arm delivery devices of the invention, is disposed within the distal end35of the receiving arm15so that the needle40advances substantially perpendicular to the body of the capture portion55. In other words, the capture portion defines a plane that is substantially perpendicular to the advancing needle40. As the needle40advances, at least a portion of the needle40enters substantially perpendicular into the capture portion55, and, as the needle40retracts, the needle40retains at least some of the capture portion55into at least one of the needle's40retaining slots215. A portion of the needle40may partially enter the capture portion55or a portion of the needle40may pass through the capture portion55prior to retraction.

As shownFIGS. 13a-13f, the capture portion55is a mesh catch185.FIG. 13bshows a close-up of mesh catch185. The mesh catch185has a plurality of openings195. Because the needle40can enter any one of the plurality of openings to capture the implant, the mesh catch greatly increasing the acceptance range of the needle40and the probability that the needle40will capture the implant assembly to position the sling165. Each opening is defined by at least one flexible edge, or wall,195of the mesh catch185. The mesh catch can be formed from a single structure, e.g. a synthetic mesh formed in a mold, or, alternatively, the mesh catch is a net, e.g. mesh formed by knotting together, for example, twine, cords, rope, or thread. The mesh catch185can be directly attached to a suture205or attached to two or more arms207extending from the suture205.FIG. 13dshows the mesh catch coupled to the implant165prior to placement of the mesh catch185into the cavity240of the distal end35of the receiving arm15.FIG. 13edepicts the mesh catch185disposed within the cavity240. The arms207coupled to the mesh catch185are releasably held within the slits145. The mesh catch185, as disposed within the cavity240, is substantially perpendicular to the advanced needle40. As further shown inFIG. 13e, the distal portion of the needle40enters into one of the plurality of openings195. As the needle40advances into one of the plurality of openings195, the flexible edge190of the opening moves to allow the needle40to pass through the opening195. When a retaining slot215of the needle40passes the flexible edge190, the flexible edge190moves into the retaining slot215. This movement of the flexible edge190into the retaining slot215allows the needle40to capture the implant assembly.

FIG. 13fshows a partially retracted needle40with the mesh catch185retained/captured within one of the needle's40retaining slots215. As the needle40retracts, the needle40pulls the mesh catch185along with the sling165and delivers the sling165to a desired position.

In other embodiments, the capture portion55is a bundled catch. The bundle catch is a three-dimensional catch defining a volume that is configured to receive at least a portion of the needle into the bundle catch. In addition, at least a portion of the bundled catch is configured to enter one or more retaining slots of the needle40. Various embodiments of the bundled catch are described hereinafter.

As shown inFIG. 14b, the bundled catch200comprises a plurality of flexible curved members210disposed between two arms207to form a sphere-like shape. The flexible curved members210flex to allow the needle40to enter into the body of the bundled catch200. When a retaining slot215of the needle40passes by one of the flexible curved members210, the flexible curved member210can enter one or more retaining slots215. This allows the retaining slot215to capture the implant assembly. One or more of the plurality of flexible curved members210can enter any one of a plurality of retaining slots215disposed on a needle40.

FIG. 14cdepicts the bundled catch200prior to placement within the cavity240of the distal end35of the receiving arm15. As shown inFIG. 14d, the arms207are disposed within the slits145to releasably hold the bundled catch within the cavity240of the distal end35of the receiving arm15.FIG. 14dalso shows the distal end45of the advanced needle40as received into the body of the bundled catch200, and shows the flexible curved members210as entered into the retaining slots215of the needle40. The needle40has retaining slots215located on the top portion and bottom portion that align with the direction of the flexible curved members210for capture.FIG. 14eshows the needle40partially retracted with the bundled catch200captured in the retaining slots215. As the needle40continues to retract, the needle40pulls the bundle catch200along with the sling165and delivers the sling165to a desired position.

As shown inFIG. 15b, the three-dimensional bundle catch400that includes a plurality of looped members220connected directly connected to the suture205. In one embodiment, the looped members220are flexible with some rigidity.FIG. 15bshows close-up view of the bundle catch400with a plurality of semi-rigid looped members220that form a spherically-shaped catch, which resembles the looped wires that form a whisk. Alternatively, the looped members220can include a plurality of looped non-rigid members, e.g. series of looped cords or threads.

FIG. 15cshows the bundled catch400prior to placement within the cavity240of the distal end35of the receiving arm15. Because the bundle catch400is attached directly to the suture205, the distal end35of the receiving arm has one slit145for releasably holding the bundle catch400.FIG. 14dshows the bundle catch400disposed within the cavity240of the distal end35. As disposed within the catch, the looped members240are in a vertical orientation. The needle40is shown advanced into bundle catch40. The needle40has retaining slots215on the sides of the needle40to allow the vertically orientated looped members240to enter the retaining slots215.FIG. 14eshows the needle40partially retracted with the bundled catch400captured in at least one of the retaining slots215. As the needle40continues to retract, the needle40pulls the bundle catch400along with the sling165and delivers the sling165to a desired position.

FIG. 16shows a three-dimensional bundle catch300that is a threaded/netted ball structure. Although not shown, the bundle catch300can be part of an implant assembly like other embodiments of the bundle catch200and400. The bundle catch300has multiple layers of threaded/netted material arranged in a ball-like structure. The layers of netted/threaded material are preferably loosely-packed to allow the distal end45of a needle40to enter and/or pass through the bundle catch300. As the needle40retracts, at least a portion of the bundle catch300is deposited in one or more retaining slots215of the needle40. This allows the needle to pull the bundle catch300along with the sling165and deliver the sling to a desired position.

The capture portions described above can be formed from many suitable materials. Exemplary materials include, for example, synthetic materials, natural materials or a combination thereof. The capture portion may be formed in any manner including but not limited to knitting, weaving, non-woven constructions, braiding, layered filaments or materials. The capture portion may be fabricated from any of a number of biocompatible materials, such as nylon, silicone, polyethylene, polyester, polyethylene, polyimide, polyurethane, polypropylene, fluoropolymers, copolymers thereof, combinations thereof, or other suitable synthetic material(s). In some embodiments, the capture portions comprise a sheet or layer of material that can be pierced by a needle for capture.

EQUIVALENTS