US 20090216075 A1
This invention relates to a surgical implant system for repairing pelvic prolapse in a patient. In particular, the present invention relates to an implant, a delivery device and a method for implanting and securing the implant to tissue structures in the pelvic region of the body.
1. An apparatus for treating pelvic floor disorders comprising:
an implant having at least one arm extending from the implant that is adapted to secure the implant to a tissue structure,
a delivery device having a housing with a passer disposed inside, said passer configured to penetrate said tissue structure to form a generally circular path when advanced from the housing,
said passer further adapted to couple to the arm and pull the arm through said path when retracted.
2. The delivery device of
3. The delivery device of
4. The implant of
5. The arm of
6. The arm of
7. The arm of
8. The differentiators of
9. The connector of
10. The arm of
11. The arm of
12. A delivery device for securing an arm extending from an implant to a tissue structure comprising:
a housing with a passer disposed within,
the passer configured to penetrate at least a portion of the tissue to form a generally circular path when advanced from the housing in a plane orthogonal to the longitudinal axis of the housing, said passer having a connector adapted to couple to the arm after penetrating the tissue structure,
and said passer further adapted to pull the arm back through the path when retracted.
13. The delivery device of
14. The delivery device of
15. The generally circular path of
16. The generally circular path of
17. The apparatus of
18. The apparatus of
19. The mechanical coupler of
20. The delivery device of
21. The passer of
22. The generally circular path of
23. The delivery device of
24. An apparatus for securing an arm of a surgical implant to at least a portion of a tissue structure comprising:
a tubular housing containing a guide, said guide adapted to penetrate the tissue structure in a substantially circular path when advanced from the open distal end of the housing,
a strap tube connected to the arm and disposed about the guide,
a pusher disposed about the guide in a proximal position to the strap tube,
and said pusher adapted to push the strap tube along the guide.
25. The guide of
26. The substantially circular path of
27. The housing of
28. The apparatus of
29. A surgical kit for treating pelvic prolapse comprising:
an implant arm having at least one arm extending therefrom,
a delivery device for securing said arm to a portion of pelvic tissue comprising a passer configured to penetrate at least a portion of the pelvic tissue in a generally circular path when advanced,
said passer having a connector adapted to couple to the arm after penetrating the pelvic tissue,
and said passer adapted to pull the arm through the path when retracted.
30. The delivery device of
31. The circular path of
32. The surgical kit of
the wide opening forming an opening in the drape and the narrow opening sized for placement into a surgical incision, said funnel further adapted to receive the implant.
33. The funnel of
34. The funnel of
35. A method of securing an implant having at least one arm to the pelvic cavity of a patient comprising:
making an incision in the vaginal wall,
positioning a delivery device having a housing into the incision, the delivery device also having a passer,
advancing the passer from the housing and penetrating an adjacent tissue structure in a generally circular path,
coupling the passer to the arm,
retracting the passer and pulling the coupled arm back through said path.
36. The method of
37. The method of
38. The method of
39. The method of
40 The method of
41. The method of
42. The method of
43 The method of
44. The method of
introducing the implant through the funnel,
pulling a free end of the arm back through the funnel after securing the delivery device to the incision.
45. The method of
46. The method of
47. A method of securing an implant having at least one arm to the pelvic floor of a patient comprising:
making an incision in the vaginal wall,
positioning a delivery device having a housing and a guide into the incision,
advancing the guide through at least a portion of a tissue structure, said guide having a proximal end adapted to penetrate tissue structures in a generally circular path,
advancing a strap tube which is connected to the arm and disposed about the guide, along the path of the guide by using a pusher, said pusher being disposed about the guide.
48. The method of
49. The method of
50. The method of
51. The method of
52. The method of
This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/013,619, filed Dec. 13, 2007, and U.S. Provisional Application No. 61/030,439, filed Feb. 21, 2008 the entire contents of which are hereby expressly incorporated by reference.
This invention relates to a surgical implant system for repairing pelvic floor prolapse in a patient. In particular, the present invention relates to an implant, a delivery device and a method for implanting and securing the implant to tissue structures in the pelvic region of the body.
Pelvic floor disorders are a type of abnormality that affects the pelvic region and is a painful and dangerous condition whereby delicate anatomical structures can shift and even protrude into other pelvic structures such as the bladder, rectum and vagina. Typical pelvic floor disorders include vaginal vault; whereby the vagina prolapses on itself usually following hysterectomy, rectocele; a protrusion of the rectum into the posterior vaginal wall, enterocele; a protrusion of the small bowel into the posterior vaginal space, uterocele; a collapse of the support for the uterus and subsequent falling into the vagina and urethrocele; a collapse of the bladder and/or the urethra into the anterior vaginal wall. This displacement from a normal position of these organs is caused by damage or stretching of complex supporting structures such as ligaments or muscles. Once these supporting structures are compromised, artificial methods must be utilized to restore these anatomical structures to their proper position and provide long term securement in place. This condition is often treated by systems that position a surgical implant, often a mesh, into the pelvic cavity. This mesh requires some fixation through deep structures such as ligaments or muscles or through the skin.
The mesh implants often have straps that fix in anterior and posterior structures. The straps are positioned using various needle assemblies that create pathways in tissue that extend from the pelvic cavity to the skin. These needle assemblies pass from outside the body into the pelvic cavity to collect the straps whereby they may be pulled outside the body and secured. Alternatively these straps may be secured by needles that create pathways in tissue which are passed from inside the pelvic cavity and pass in the opposite direction to the skin outside the body. The passage of these long needles requires considerable skill so that the needles do not damage nerves or blood vessels present in the needle pathways. The passage of these needles is performed without direct visualization so considerable skill on the part of the surgeon is required to avoid these critical structures and to place the implant correctly. In some procedures these mesh implants are secured directly to the pelvic region using staples or suture and these can pull out over time and are often the cause of considerable pain and discomfort for the patient. Thus there is a need for an improved device and method for the treatment of pelvic floor disorders that eliminates the passage of these needles through delicate structures and avoids sutures or staples. A device that can deliver and secure a strap to the pelvic region from within the pelvic floor region without requiring long needle passes through the skin is needed.
The present invention generally describes systems and methods to treat pelvic floor disorders, particularly pelvic prolapse conditions and /or urinary incontinence using single incision techniques through the vaginal wall. In this type of procedure, access to the pelvic floor cavity is made through the anterior or posterior vaginal wall so that supporting structures such as slings or mesh implants may be introduced and secured to support the urethra, bladdemeck, vagina, bladder and pelvic floor. Access through the vagina may be used to insert, position, tension and fixate an implant to the pelvic floor without requiring dangerous blind procedures described previously. Devices and methods that utilize single incision surgery may be safer, quicker and less traumatic for the patient.
One aspect of the invention is an apparatus for treating pelvic floor disorders. The invention includes an implant that has at least one arm extending from the implant. The implant arm is adapted to secure the implant to a tissue structure by generally passing through or around the tissue. The invention also includes a delivery device to deliver the apparatus to the treatment area and may have a housing with a passer disposed inside. The passer may be configured to penetrate pelvic tissue structures in a generally circular path when it is advanced from the housing. The passer may be further adapted to couple to the implant arm and pull the arm through the path when it is retracted.
In another embodiment of the invention, the delivery device may have the arm detachably coupled to the housing and the arm may be positioned to intersect the expected path of the passer such that a distal end of the passer contacts and couples to the arm before the passer is retracted. The arm may also be preloaded onto the housing before insertion into the pelvic floor region of the body.
In another embodiment, the arm may be positioned independently from the implant A connector may be configured to detachably couple the arm to the implant such that the arm may be first secured to a tissue structure, then the implant is introduced and the arm may be coupled to the implant. This may allow strap placement before the implant is introduced and secured. In another aspect the arm may have an inner portion and an outer portion with the two portions detachably joined together end to end with a removable cord. This cord may be removed or severed so that the distal portion separates from the proximal portion.
Another aspect of the invention is a delivery device for securing an arm extending from an implant to a tissue structure. This delivery device may have a housing with a passer disposed within. This passer may be configured to penetrate at least a portion of the tissue structure to form a generally circular path when it is advanced from the housing. This advancement may be in a plane orthogonal to the housing's longitudinal axis and the passer may have a connector adapted to couple to the arm after penetrating the tissue structure. The passer may be used to pull the arm back through the path when it is retracted. This delivery device may also include a pivot and an actuator that is coupled to the passer and this passer may have a circular radius and be configured such that as the actuator is advanced, the passer rotates about the pivot in the generally circular path. In general the circular path may encircle various ligaments or pelvic tissues such as the sacrospinous ligament or the arcus tendineus.
In one embodiment the connector described is a magnetic coupler and in another the connector is mechanical coupler. The delivery device may be rigid or it may be flexible and may have a preset or flexible shape.
In another embodiment the passer may be made from a super elastic alloy that has a pre-set radius and the passer may be confined to a straightened condition by an outer tube and configured such that as the passer is advanced from the tube it penetrates tissue in a generally circular path.
Another aspect of the invention is an apparatus for securing an arm of a surgical implant to a tissue structure. The apparatus may have a tubular housing that contains a guide and the guide may be adapted to penetrate the tissue in a substantially circular path when advanced from the open distal end of the housing. The apparatus may further include a strap tube that is connected to the arm and disposed about the guide. Additionally a pusher may be disposed about the guide in a proximal position to the strap tube and the pusher may be adapted to push the strap tube along the guide.
A further embodiment of the invention is a surgical kit for treating pelvic prolapse including an implant arm with at least one arm, a delivery device for securing the arm to the pelvic tissue and a funnel. The funnel may have an attached drape and a retention ring adapted to retain the funnel in an incision.
Another aspect of the invention is a method of securing an implant having at least one arm to the pelvic cavity of a patient. The steps may include making an incision in the vaginal wall, positioning a delivery device into the incision, advancing a passer and penetrating adjacent tissue, coupling the passer to the arm, retracting the passer and pulling the coupled arm back through the tissue and withdrawing the delivery device and the arm from the incision.
The method may further include positioning the delivery device using a finger or an endoscope coupled to a distal end of the device. The method may further include positioning a funnel in the incision, introducing the implant through the funnel and pulling a free end of the arm back through the funnel.
Another embodiment of the invention is a method of securing an implant having at least one arm to the pelvic floor of a patient including the steps of making an incision in the vaginal wall, positioning a delivery device into the incision, advancing a guide through tissue, advancing a strap tube along the path of the guide by using a pusher, withdrawing the guide and pusher into the housing and removing the delivery device.
It is understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. The accompanying drawings illustrating an embodiment of the invention and together with the description serve to explain the principles of the invention.
Although many different devices and several different methods of accessing and repairing pelvic floor disorders such as fecal or urinary incontinence, vaginal vault prolapse, vaginal hernia, rectocele, enterocele, uterocele, and urethocele or combinations of these disorders have been tried, including surgical and laparoscopic procedures, a better device and method are needed. Particularly a device that can be easily implanted and secured to pelvic floor structures without requiring dangerous and highly skilled needle passes through the skin is necessary. An implant and implantation method that permit introduction of a delivery device to which is attached a surgical implant to the pelvic cavity using a small incision, that can be implanted and secured without exceptional skill by the surgeon or risk to the patient may lead to better outcomes.
Although the repair of pelvic floor disorders is particularly referenced, it is anticipated that the apparatus and methods described herein may be used for other surgical or laparoscopic procedures whereby a tissue structure of the human body requires strengthening or supporting. The delivery devices described are applicable to pelvic floor disorders but may be used wherever a strap, cord, arm or suture needs to be passed through a tissue of the body.
Referring now to
The implant 30 may be made initially oversized compared to the size of the pelvic disorder. The implant may be sized substantially larger than the area of the disorder and the implant 30 may be trimmable so that the implant may be trimmed in situ to fit the size of the interventional need. In this way one implant size may be provided to the user and then the implant custom trimmed to fit the surgical conditions.
The arm 32A-E may be used to secure the implant 30 to the pelvic cavity and if more than one arm 32 is used then they are preferably symmetrically arranged around the perimeter of the implant 30. Although five arms 32A, 32B, 32C, 32D, and 32E are shown in
The arm may be identified with unique identifying characteristics called differentiators so that one arm may be discerned from another. In this way an arm corresponding to a particular location on the implant may be identified and the anatomical position of the arm can be discerned. By way of example that is not meant to be limiting, each arm may have a different color coding so that when the implant is inside the pelvic space, the orientation of the implant may be discerned and correct positioning of the arms to avoid entanglement can be realized. The arm may be further differentiated from other arms by degrees of radiopacity, by an identifying structure such as interwoven threads, by a printed number on the arm itself, or by differences in materials. Other means of differentiation are possible and these examples are not intended to be limiting.
The arm may have different configurations and the device 28 may utilize one configuration only for a particular implant or multiple configurations may be utilized on a single implant. However the arm is generally flexible and not rigid. While other prior art devices utilize stiff and rigid engagement type arms and especially rigid placement needles or trocars, the present invention is flexible. The arms are adapted to pass through or in some case around pelvic tissue structures such as the sacrospinous ligament or the arcus tendineus.
Arm 32A is shown as a woven mesh that is integrally formed as an extension of the implant mesh 30. In this configuration the arm 32A is a mesh strap that may extend 2-20 inches from the perimeter of the implant 30. As can be shown the arm 32A has a tapered end 33 that reduces the width of the strap. The end of the arm may have a piercing element 34 attached at the end of the arm.
Arm 32B, having an inner end 35 and an outer end 36, is shown coupled to the implant 30 at inner end 35. Inner end 35 is located interiorly from the perimeter of the implant 30. This attachment location may facilitate trimming the implant area at the interventional site because the attachment point is set apart from the edge that might be trimmed. The attachment location could be located anywhere on the implant and is not limited to a particular location. Secondly, arm 32B is not integral to the implant 30 but is a separate arm. Arm 32B is attached to the implant with a connector 37 at the end 35 of the arm 32B. This arm may be deployed as part of the implant or may be decoupled from the implant and re-coupled later. This configuration of implant allows separate placement of the arm and implant. In some situations it may be preferable to position the arm 32B prior to insertion of the implant. In other situations it may be preferable to position the arm after the implant is positioned. The connector 37 may be any type of mechanical connector, magnetic connector, adhesive or other connector. Some examples of mechanical connectors are hooks, snaps, threaded sections, bayonet fastener, hook and loop type fastener, snares, buttons, suture, or clamps although any type of connector may be suitable and this list is not meant to be limiting.
Arm 32B also has a detachment zone 38 that is the coupling zone for the inner portion 32B and the outer portion 40. Outer portion 40 has inner and an outer ends 41 and 42. The inner end 41 of the outer portion 40 is coupled to the outer end 36 with the use of cord 44. The cord 44 may be a thread, suture or other similar material configured so that the two described ends 36 and 41 can be coupled by loosely tying them together. An end of the cord 46 may extend outside the body. Together the arm 32B and the outer portion 40 provide a long enough length of strap so that the combination can be used to tension the implant by pulling the outer portion 40 from outside the body. However, once the implant is tensioned properly any excess arm is unnecessary and is often removed so that the end of the arm can be positioned inside the incision. Therefore the excess may be cut away but the optimal cutting point may be deep inside the pelvic cavity and difficult to reach especially with a small incision. Therefore the detachment zone 38 is intended to provide a remote method of detaching unneeded length of the arm that is inside the incision. The cord 44 may be severed at the detachable zone 38 with a blade or may be released by pulling on the cord end 46 from outside the body. In another embodiment of the invention the arm 32B terminates at outer end 36 and outer portion 40 is not present. However cord 44 may still be threaded through the outer end 36 only. Tension may be applied to the arm by pulling on the cord 44. After proper positioning and tensioning of the implant 30, the cord may be removed from the arm 32B by pulling on the cord end 46 so that the outer end 36 remains inside the pelvic cavity.
In another embodiment of the arm 32C, the width of the arm is reduced to facilitate pulling the arm through various tissue structures. The reduced lateral profile may reduce friction and the resultant force required to pull or push the arm. The arm 32C profile may be reduced by spinning, forming or winding the arm 32C material into a smaller diameter and thereby forming a cord or leader. The arm 32C profile may be reduced by the use of a sleeve 50 disposed around the arm. Such a sleeve 50 may be made of polyethylene, polypropylene, nylon, silicone or other suitable polymer that may be useful to reduce the friction as the arm passes through tissue structures. The sleeve 50 may be made from a shrink tubing. Arm 32C may have all or a part of its length comprised of a leader 52. This leader may be made of suture, cord, string, wire or other suitable flexible material. This leader 52 may be coupled directly to the implant 30 or may comprise a portion of the arm 32C and a piercing member may or may not be attached at the end. The outer end of the arm may also terminate with an anchor 54 or 56 attached to arms 32D and 32E. Arms 32D and 32E may be positioned in a tissue structure either by pushing or pulling the arms as will be shown. These arms' outer ends enter tissue structures and then anchor into the tissue to secure the arm to the tissue. Various anchor designs are anticipated and the anchors 54 and 56 are not meant to be limiting. Anchor 54 is shown having lateral barbs 55 that may have a fixed configuration or these barbs may be deployable after positioning. The anchor 56 is a barbed hook which may pass easily into tissue and then inhibit reverse movement to prevent pullout of the anchor and arm.
Referring now to
The delivery device 100 includes a housing 102 having a cavity 104 disposed at its distal end 106. A curvilinear passer 108 having an inner end 109 and an outer end 110 is disposed inside the housing 102. The outer end 110 is sharpened to facilitate passage through tissue structures. The inner end 109 is coupled to the housing 102 at a rotating pivot 112 so that the passer can rotate about this pivot in a generally circular pathway. The passer 108 is rotatably linked to an actuator 114 at linkage 116 and the actuator is slidably disposed inside the housing. The outer end 110 of the passer may also have a connector 118 that is adapted to couple to an arm. As shown in
Once the arm 119 is coupled to the connector 118, the actuator may be retracted away from the distal end 106 which also retracts the passer 108. This movement pulls the arm 119 along the generally circular pathway of the passer, and back into the housing. The delivery device 100 may be withdrawn in the direction of the arrow, pulling the arm through or around the tissue structures. In the case of pelvic prolapse repair, the delivery device 100 maybe used to position the arms in or around various tissue structures such as the sacrospinous ligament, arcus tendineus, bone or other pelvic structures.
An alternate delivery device 130 is shown in
An alternate delivery device 140 is shown in
Alternate connectors are illustrated in
Also shown is connector 160 attached to a passer (not shown) similar to those discussed. The connector 160 may be a threaded rod 162 that is configured to mate with a similarly threaded tube 164 attached to an arm 165. As the threaded rod 162 passes through tissue structures and approaches the threaded tube 164, the two may be coupled by screwing the two together and the arm 165 is detachably joined to the connector 160. The threaded coupling should be strong enough to maintain the coupling as the passer is withdrawn pulling the arm 165 through tissue structures.
In addition to these connector examples shown, the passer 152 may utilize any number of mechanical connectors such a barb, a spear, a threaded connector, a snap, a bayonet system, a latch, a clamp, hook and loop type fasteners or a jaw. Any connector that can couple an end portion of the arm with the passer tip may be used. Likewise any number of magnetic couplers as well as adhesives may be utilized. The list of potential couplers is large and any number of suitable connectors known by those skilled in the art may be successfully employed. An alternate embodiment of an arm delivery device 200 is shown in
In use, the body 201 is introduced into the pelvic cavity through an incision in the vaginal wall and the guide 204 is extended from the housing 202 such that the guide makes a generally circular pathway through and around tissue structures 218 and enters the opening 214 in the body 201. Alternatively other sites other than the vaginal example given may be used to insert the delivery device into the pelvic cavity. If this is used outside the pelvic region, then other suitable entry sites may be used.
The housing 202 is then extended from the body and the strap tube 208 is pushed from the housing along the guide 204 by the pusher 210. The strap tube 208 is pushed through tissue structures 218 while following the guide until it enters the opening 214 and is captured by the catch 212. At this point the strap tube is coupled to the body 201. The guide, pusher and housing are retracted back into the body and the body removed from the pelvic space. As can be seen, as the body is withdrawn, the arm 216 is positioned through and around tissue structures 218. The device of
As shown in
All the delivery devices previously described may be placed in the pelvic cavity using positioning aids to guide and direct the placement of the arms. These aids may utilize tactile or visual feedback to the operator so that tissue structures such as arteries, veins, nerves, bone, ligaments or tendons in the body can be identified and the placement of the arm may be properly directed compared to a blind approach. Referring to
Multiple arms may be used to secure an implant in the pelvic space. These arms may have cords or leaders that extend from the distal ends of the arms that may be used to tension the implant. Keeping these ends organized and identified may be challenging. Additionally the sterility of all of these loose ends and the implant must be maintained in a crowded surgical site. To organize and identify the various cords coming from the arms, the leaders themselves or the arms may be color coded, shape coated or in some other way uniquely identified with differentiators so that an individual arm and its location to the implant and the pelvic cavity can be determined.
A device to organize the method of implanting the implant and providing a large sterile barrier is illustrated in
This invention has been described and specific examples of the invention have been portrayed.
The use of those specifics is not intended to limit the invention in anyway. Additionally, to the extent that there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is our intent that this patent will cover those variations as well.