[0001] This application claims the benefit of the filing date of United States Provisional Patent Application Number 61/614,053, filed March 22, 2012. the contents of which are hereby incorporated by reference.

TECHNICAL FIELD

[0002] The present embodiments generally relate to medical devices for prolapse repair within a body and to methods of use thereof.

BACKGROUND

[0003] Prolapse is a medical term used to describe an organ that has fallen out of place from its usual position. Pelvic organ pro lapse is a condition where the bladder and/or uterus literally fall down out of their anatomical positions due to weakening or deterioration of the tissue(s) that hold the organs in place. When this occurs, the unsupported organs fall on top of the anatomical structures directly below them. The bladder lands onto the vaginal canal causing the vagina to invert and protrude outside of the body. The uterus lands onto the anal canal likewise causing the rectum to invert and protrude outside of the body. The breakdown in the tissue(s) supporting pelvic organs can be a result of child birth, surgery within the pelvic region and normal weakening of tissue due to old age.

[0004] To repair the prolapse, a gynecological surgeon can reconstruct or fully replace the broken-down tissue by implanting a surgical repair-graft. When a graft is implanted, it must be fixated properly in order to reposition and keep the organ(s) in the natural anatomical position. The most common fixation technique is to attach the graft to ligaments within the pelvic region. Ligaments are very strong fibrous tissues that attach bones to other bones. The most common ligaments used are the sacrospinous and uterosacral ligaments.

[Θ005] Fixation of the graft to the ligaments is achieved by tying with surgical suture. Prolapse repair procedures are commonly performed as a minimally invasive procedure. For example, an incision isi the vaginal canal is made in order to gain access to the pelvic cavity so the graft can be implanted. Once in the pelvic cavity the surgeon first threads suture strands at different points along each ligament. Threading the ligaments can be highly challenging because of three primary factors. First, the ligaments are located deep inside the pelvic cavity and are difficult to reach. Second, the small incision restricts the amount of space the surgeon has to work and maneuver within, and lastly the procedure is performed blindly without the help of medical imaging.

[0006] Because of these and other factors, surgeons utilize long suturing devices to help them access the ligaments. Suturing devices on the market today- may come with their own customized suture "packets." For example, suture device may come with suture packets consisting of a loose strand of suture with a piercing device at the end of the strand. The suture is loaded onto the suturing device by positioning the piercing device at the end of the device head. This device punctures the ligaments and threads the suture strand therethrough,

[0007] There are at a number of deficiencies with these suturing devices and the suture packets that accompany such devices. First, the devices do not allow the user to maintain tension on the suture strand while the device is maneuvered through the pelvic cavity. In addition, when using such devices the user must use one hand to hold and maneuver the device while the other hand holds the suture taut. These factors can increase both the complexity and time required to complete the procedure.

BRIEF SUMMARY

[Θ008] One aspect of the present invention provides a suture cartridge including a cartridge housing having a first end wall, a second end wall and a side wall extending between the first and second end wails. The first end wail includes a hub extending into the interior of the cartridge housing from the first end wall. The axis of the hub ex tends through the center of a circular opening in the second end wall. A spool is positioned in the cartridge housing between the first end wall and the second end wail and is supported for rotation about the hub by the hub and by the perimeter of the circular opening in the second end wall. An external wail of the spool is posi tioned in the circular opening and includes a slit positioned at the perimeter of the external wail. A spring is positioned on the hub between the first end wall and the spool and engages a first notch on the hub and a second notch on the spool. In one embodiment, a suture support assembly is positioned on an external surface of the side wall. The suture support, assembly can include a first suture support element extending from the side wall of the cartridge housing adjacent to the first end wall of the cartridge housing and a second suture support element extending from the side wall of the cartridge housing adjacent to the second end wall of the cartridge housing. The cartridge housing also includes a slot extending from a position on the side wall to the circular opening. In one embodiment, the slot extends from adjacent to the support assembly to the circular opening.

[0009] in one embodiment, a suture having a first looped end and a second end attached to a needle is positioned within the suture cartridge. In another embodiment, the first looped end is supported by the suture support assembly, the suture extending from the first looped end, through the slot, around the spool, and exiting the cartridge housing thro ugh the slit in the external wall of the spool. In yet another embodiment, a number of retainers are positioned on the external wall of the spool so as to hold the needle against the external wail.

fOOlti] in another embodiment, the suture cartridge is provided with a locking tab. The locking tab includes a handle element positioned on an external surface of the side wall of the cartridge housing and a locking element attached to the handle element and extending through the side wall of the cartridge housing. The handle element is movable between a first position where the locking element engages the perimeter of the spool and a second position where the locking element is positioned away from the perimeter of the spool. The perimeter of the spool can include a plurality of gear teeth.

[001 ij Yet another embodiment of the suture cartridge includes a telescopic arm having a first end attached to the second end wail of the cartridge housing and extending to a second end positioned over the external wail of the spool, The external wall includes a spiral groove extending from, a first stop near the extended axis of the hub to a second stop positioned radially away from the first stop and towards the perimeter of the circular opening. The second end of the telescopic arm can include an engagement element, which is positioned in the spiral groove. A hole in the external wall of the spool, of a greater depth than the groove, is positioned at either the first stop or the second stop. The engagement element is sized and shaped to fit into the hole in the wall of the spool. Rotation of the spool is prevented when the engagement element is positioned in the hole.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is an illustration showing the components of one embodiment of a suture cartridge,

[0013] Figures 2(a) and 2(b) are illustrations showing one embodiment of a suture cartridge.

[00141 Figures 3(a) and 3(b) are illustrations showing partial views of another embodiment of a suture cartridge. In Figure 3(a) the locking tab is positioned to allow rotation of a spool within the cartridge housing, in Figure 3(b) the locking tab is positioned to prevent rotation of the spool.

[0015] Figures 4(a) and 4(b) are illustrations showing partial views of yet another embodiment of a suture cartridge,

[001.6] Figures 5(a) and 5(b) are illustrations showing the placement of one embodiment of a suture cartridge on a suture device. Figure 5(a) illustrates the placement of the looped end of the suture onto the suture device. Figure 5(b) is an enlarged illustration showing the placement of the looped end of the suture onto the suture device. Figure 5(c) illustrates the placement of the suture cartridge on the device. DETAILED DESCRIPTION

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0018] The terms "proximal" and "distal" as used herein are intended to have a reference point relative to the operator of the suture device. Specifically, throughout the specification, the terms "distal" and "distal ly" shall denote a position, direction or orientation of a device that is generally away from the user then the device is partially inverted into a body cavity of a subject. Similarly, the terms "proximal" and "proximally" shall denote a position, direction or orientation of a device that is generally towards the user then the device is partially inverted into a body cavity of a subject.

[0019] One aspect of the present invention provides a suture cartridge having a suture positioned around a spool contained within the cartridge housing, in certain embodiments, the suture cartridge includes a cartridge housing, a suture with a looped end and a needle attached to the other end, a suture spool, and a spring inside the spool that keeps the suture taut when the device is in use.

[0020] Figure 1 illustrates the components of one embodiment of the suture cartridge. Suture cartridge 100 includes a cartridge housing including first end wall 102, second end wall 104 and side wall 106 extending between the first and second end walls. First end wall 102 includes hub 108 extending into the interior of the cartridge housing. An axis of hub 108 extends through the center of circular opening 1 10 in second end wall 104.

[ΘΘ21] Spool 1 12 is positioned within the cartridge housing between first end wall 102 and second end wall 104 and is supported for rotation on hub 108 by the hub and by perimeter 1 14 of circular opening 1 10 in second end wall 104, External wall 1 13 of spooi 1 12 is positioned in circular opening 1 10. Slit 132 in external wall 113 is positioned at the perimeter of externa! wall 1 13. Spring 116 is positioned on hub 108 between first end wall 102 and spool 1 12 and engages a first notch 1 18 in hub 108 and a second notch (not illustrated) in the spool 1 12.

[0Θ22] In certain embodiments, a suture support assembly is positioned on an external surface of side wall 106. In one embodiment, the suture support assembly includes first suture support element 120 extending from side wall 106 of the cartridge housing adjacent to first end wall 102 and second suture support element 121 extending from side wall 106 adjacent to second end wall 104. Support element 120 and 121 are positioned side by side to allow for looped 130 of suture 126 to be held by these elements. Such an embodiment is illustrated in Figures 1 and 2.

[0023J However, other embodiments of suture support assembly are also encompassed in the present embodiments. The function of the suture support assembly is to hold looped end 130 of suture 128 and possibly assist in the loading of looped end 130 onto a suturing device. Any structure that provides one of both of these functions can be incorporated into the suture cartridge housing. In other embodiments, no suture support assembly is present on the suture cartridge housing.

[0024] The suture cartridge housing also includes slot 122, which extends from a position in slide wail 106 adjacent to the suture support assembly (if present) to the perimeter of circular opening 1 10. Suture 128 is loaded into the suture cartridge 100 so that looped suture end 130 is positioned outside the cartridge housing with looped suture end 130 positioned on the suture support assembly (if present). Suture 128 extends through slot 122 at side wail 106 into the cartridge and is looped around spool 3 12. Suture 128 then exits the cartridge through slit 132 in external wall 113 of spooi 1 12, Needle 126 is attached to the non-looped end of suture 128. In one embodiment, needle 126 is a standard surgical needle for use for threading suture through a graft material. [0025] Figure 2 illustrates one embodiment of the suture cartridge with suture 128 loaded into the cartridge. Here, looped suture end 130 is positioned on suture support elements 120 and 121. Suture 128 exits the cartridge at slit 132 in external wall 1 13 of spool 1 12. In this embodiment, a plurality of retainers 134 is present on external wall 1 13, These retainers are positioned to hold the needle 126 against external wall 1 13.

[0026] Figure 3 illustrates another embodiment of a suture cartridge. Mere the suture cartridge includes locking tab 149. Locking tab handle element 150 is positioned on an external surface of side wall 106 of the cartridge housing.

Locking element 152 is attached to handle element 150 and extends through side wall 106 into the cartridge. Handle element 150 is movable between a first position where locking element 152 engages a portion of the perimeter of spool 1 12 and a second position wherein locking element 152 is positioned away from the perimeter of spool 1 12. In certain embodiments, a plurality of gear teeth 152 is present on the perimeter of spool 1 12.

[0027] Locking tab 149 allows a clinician to control the removal of the suture from the cartridge. Once a required amount of suture is extracted, the clinician presses handle element 150 to engage locking element 152 with the perimeter of spool 1 12. By doing so, the clinician prevents further rotation of spool 1 12 and any pull back of the suture into the cartridge by spring 1 16.

[0028] Figures 4(a) and 4(b) illustrate yet. another embodiment of the suture cartridge. Figure 4(a) illustrates a suture cartridge similar to the embodiment shown in Figures 2(a) and 2(b). However, this embodiment also includes telescopic arm. 206 ha ving a first end attached to second end wall 104 of the cartridge housing and extending to a second end positioned over external wall 1 13 of spool 1 12. External wall 1 13 includes spiral groove 204 extending from first stop or end 220 positioned near the extended axis of the hub to second stop or end 224 positioned radially away from first stop 220 and towards the perimeter of circular opening 1 10. The second end of telescopic arm 206 includes engagement element 222 which is sized and shaped to fit into spiral grove 204. In. one embodiment, telescopic ami 206 is spring loaded, whereby engagement element 222 is pressed against a surface of groove 204,

[0029] Figures 4(a) and 4(b) also show hole 208 in external wall 113 of spool 1 12, positioned within spiral groove 204 at or near second stop 224. Hole 208 is of a greater depth than the depth of spiral groove 204. in another embodiment, hole 208 is positioned at first stop 220 instead of at second stop 224. In operation of the suture cartridge, engagement element 222 is positioned in spiral groove 204 at or near the end of spiral groove 204 not including hole 208. As the suture is withdrawn for the suture cartridge and spool 1 12 rotates, the configuration of spiral grove 204 is such that engagement element 222 moves along spiral grove 204 towards hole 208. Upon reaching hole 208, engagement element 222 falls or is pushed into hole 208, whereby further rotation of spool 1 12 is prevented. The ability of the suture cartridge to auto-lock once a certain amount of suture has been extracted from the cartridge allows the clinician can easily remove suture needle 126 without fear of the cartridge reel pulling the suture back rapidly and causing the needle to injure the clinician.

[0030] Another aspect of the present embodi ments pro vides a method of repairing a prolapse within a body cavity using one of the embodiments of a suture cartridge disclosed above, Figures 5(a-c) show suturing device 500 and suture cartridge 100. In Figures 5(a) and 5(b), suture cartridge 100 is positioned at the distal end of suturing device 500 to illustrate the placement of looped end 130 of the suture onto suturing device 500. The distal end of the device includes suture connector 512 and articulating arm 504 having suture grab 514 positioned at or near its extremity. The suture is loaded onto suturing device 500 by placing looped end 130 of the suture on suture connector 512. Suture cartridge 100 is then connected to the handle 520 of suturing device 500. In one embodiment, suture cartridge includes attachment element 522 on the cartridge housing, for example, on the side wall of the cartridge housing. Attachment element 522 is sized and shaped to connect to handle 520 and to hold the suture cartridge on handle 520, thus freeing the operator from the need to continue to hold the cartridge. Figure 5(c) shows suture cartridge 100 positioned on handle 520 of suture device 500. Looped end 130 of suture is connected to suture connector 512 and suture 128 extends from the suture connector to suture cartridge 100.

|0031] Once the suture cartridge is loaded onto the suturing device, the device is ready for use in reconstructing or ftilly replacing the broken-down tissue by implanting a surgical repair graft. The distal end of suturing device 500 is inserted into a body cavity of the patient, for example into the pelvic cavity, and is positioned at a ligament within the cavity such that the ligament is positioned between suture connector 512 and articulating arm 504. The articulating arm is then activated fay trigger 502 on handle 520. Activation of articulating arm 504 causes the arm and hence suture grab 514 to move towards suture connector 512 and to hold the ligament between suture connector 512 and articulating arm 504, Second trigger 503 is then activated to cause suture grab 514 to penetrate the ligament, and to connect to the looped end 130 of suture 128. Articulating arm 504 is then returned to its original position whereby the looped end of the suture is pulled through the ligament.

[0032] The suturing device is then withdrawn from the body cavity. As the device is withdrawn, suture 130 continues to be released from the suture cartridge and to be pulled through the ligament. When the suturing device is fully withdrawn from the body cavity, needle 126 is removed from retainers 334 on external wall 1 13. Suture 130 is then removed from the suture cartridge by moving the suture along slot 122. Needle 126 can then be used to attach suture 130 to a graft material. During this process, the locking mechanism (if present) may be activated to prevent the suture from being pulled back into the cartridge.

[0033] The process outlined above can then be repeated, each time using a new suture cartridge. Each additional suture can be threaded through a different position on the ligament or through a different ligament, depending on where the graft is to be placed within the body cavity. After being threaded through the appropriate ligament, each suture is attached to the graft material using the procedure outlined above, The graft is then moved into the body cavity by pulling on the sutures at the looped ends [0Θ34] Although the invention has been described and illustrated with reference to specific illustrative embodiments thereof, it is not intended that the invention be limited to those illustrative embodiments. Those skilled in the art will i-ecognize that variations and modifications can be made without departing from the true scope and spirit of the invention as defined by the claims that follow, it is therefore intended to include within the invention all such variations and modifications as fall within the scope of the appended claims and equivalents thereof.