WO2015077310A1 - Apparatus for treating vaginal prolapse - Google Patents

Apparatus for treating vaginal prolapse Download PDF

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Publication number
WO2015077310A1
WO2015077310A1 PCT/US2014/066362 US2014066362W WO2015077310A1 WO 2015077310 A1 WO2015077310 A1 WO 2015077310A1 US 2014066362 W US2014066362 W US 2014066362W WO 2015077310 A1 WO2015077310 A1 WO 2015077310A1
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WO
WIPO (PCT)
Prior art keywords
apparatus
needle
graft
mesh
vaginal
Prior art date
Application number
PCT/US2014/066362
Other languages
French (fr)
Inventor
Dennis Miller
Original Assignee
Boston Scientific Scimed, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US14/084,956 priority Critical patent/US20140179992A1/en
Priority to US14/084,956 priority
Application filed by Boston Scientific Scimed, Inc. filed Critical Boston Scientific Scimed, Inc.
Publication of WO2015077310A1 publication Critical patent/WO2015077310A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045Support slings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/005Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable inflatable

Abstract

The invention disclosed herein includes an apparatus for the treatment of prolapse in a pelvic region of a patient. The apparatus is a graft having a central body portion and at least one wing extending from it. A needle is attached to the end of the wing opposite the central body, and the needle in configured to engage the patient's soft tissue positioned near the pelvic region.

Description

APPARATUS FOR TREATING VAGINAL PROLAPSE

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and is a continuation of, U.S. Nonprovisional Patent Application No. 14/084,956, filed on November 20, 2013, which is a continuation-in-part of U.S. Application No. 12/903,797, filed on October 13, 2010, which claims priority to U.S. Provisional Patent Application No. 61/251,049, filed on October 13, 2009, the disclosures of which are incorporated by reference herein in their entirety.

BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention

[0003] The present invention relates in general to a system and method in the field of prolapse treatment. More particularly, the present invention relates to an apparatus with multiple components and method for correcting tissue wall prolapse using the same. Specifically, a preferred embodiment of the present invention is a kit that has at least a pessary.

[0004] 2. Discussion of the Related Art

[0005] As is known to those skilled in the art, the treatment of vaginal wall prolapse has been hampered by high fai lure rates. The main reasons for failure have been the inherent weakness of the tissue being re-approximated and the inability of the repair to withstand the forces applied by the abdominal cavity bearing down from above. In the last decade, one major advance in repair has been the addition of grafts to reinforce those repairs. While this phenomenon has been gaining wide spread acceptance, there lacks a consensus regarding how to affix the graft under the vaginal wall to best maintain durability and vaginal caliber. Note that vaginal caliber is important because of its impact on sexual function.

[0006] Unfortunately, with current procedures, the graft is at risk for being dislodged over time. For example, when the graft is sewn into place with standard sutures over the pelvic floor muscles, it is prone to cause pain from suture entrapment. Further, there is concern that sutures may be prone to pullout. This is especially true since the tissues the sutures are placed in are thin and inherently weak. Finally, the placement of the sutures is variable from surgeon to surgeon. This causes an impact on teaching proper graft placement. [0007] All of the above issues may affect the success of the repair. Therefore, there is now greater interest in new ways of affixing and maintaining grafts. As a result, several recent procedure iterations have become available on the market in this regard. With the introduction of new techniques, several improved devices, such as the Prolift™ device from Ethicon, Inc., have been made commercially available. Other commercial device kits are available in this field for prolapse repair that compete with Prolift™, for example, American Medical Systems' Apogee™ and Perigee™ system, Tyco's IVS Tunneller™ system, and Bard's Avaulta™ system. In general, these systems utilize medical mesh with wings at the corners so that the mesh may be drawn through the pelvic floor musculature and pelvic ligaments to secure the mesh.

[0008] A well-accepted access point to securing the wings of these systems has been through the obturator membrane and ischiorectal fossa. Access is generally made via these structures because the apex of the vagina is located deep with the pelvis. However, the problem with accessing the apex via these structures is that this anatomy is unfamiliar to surgeons. Further, safety remains a concern for surgeons because these systems require the passage of sharp needles long distances through these unfamiliar anatomic. Thus, extensive training and anatomy education is required to properly learn the technique. As a result, only a small number of surgeons have actually adopted these techniques.

[0009] The patents and publications of general interest here include: U.S. Pat. No. 6,936,052; U.S. Pat. No. 5,364,408; U.S. Pat. No. 5,458,609; U.S. Pat. No. 5,575,800; U.S. Pat. No. 5,662,664; U.S. Pat. No. 5,540,704; U.S. Pat. No 6,470,890; U.S. Pat. Pub. Nos. 2005/0261545 and 2006/0052801; W02002/078568A1; W02003/028585A 1 ; W02002/078552A1 ; and W02004/045457 Al. These patents and published applications disclose embodiments that were at least in part satisfactory for the purposes for which they were intended. The disclosures of all of these patents and applications in their entireties are hereby expressly incorporated by reference into the present application for purposes including, but not limited to, indicating the background of the present invention and illustrating the state of the art.

[0010] In general, the embodiments disclosed in the above-referenced patents and publications have the disadvantage that they are in general difficult or dangerous to use without extensive training. Also, they are only partially effective to treat prolapse. Other disadvantages include increased risk and ineffective results over time. For example, after sutures are made, the vagina is traditionally packed with gauze. This leads to significant discomfort after surgery. If the gauze is not removed within 24 hours, infection and other problems may develop.

[0011] Given the above, patients suffering prolapse either must wait long periods of time for treatment or forego the same altogether because of the risk involved and the necessary high-level of surgeon skill. It should be noted also that only a fraction of the hundreds of thousands of patients getting prolapse repair surgery are availed to the latest technology. This further leads to a procedure with a relatively high cost.

[0012] Therefore, what is needed is a relatively simple system and method. Further, what is also needed is a system and method that are easily repeatable and highly effective over time.

SUMMARY AND OBJECTS OF THE INVENTION

[0013] By way of summary, the present invention is directed to preferably a system that includes a kit. The kit preferably has a post-operative pessary. Other components may include a pre-cut shaped mesh graft, and a graft delivery device. The present invention also includes a method of using the kit to repair a vaginal prolapse.

[0014] A primary object of the invention is to provide an apparatus that reduces patient discomfort. Another object of the invention is to provide a system that is ruggedized and reliable. Another object of the invention is to provide an apparatus that has one or more of the characteristics discussed above but which is relatively simple to implant without too much additional training.

[0015] Another object of the invention is to provide a method that can be used to prevent recurring prolapse. Another object of the invention is to provide a method that is predictable and reproducible, thereby increasing success rates and decreasing risk, pain, variance, recovery time, and medical costs. Another object of the invention is to provide a method that has one or more of the characteristics discussed above but which is relatively simple to set up and perform.

[0016] These and other aspects and objects of the present invention will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments of the present invention, is given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] A clear conception of the advantages and features constituting the present invention, and of the construction and operation of typical mechanisms provided with the present invention, will become more readily apparent by referring to the exemplary, and therefore non-limiting, embodiments illustrated in the drawings accompanying and forming a part of this specification, wherein like reference numerals designate the same elements in the several views, and in which:

[0018] Fig. la illustrates the top plan view of the pessary component of the kit of the present invention;

[0019] Fig. lb illustrates the side view of the pessary component of the present invention;

[0020] Fig. lc illustrates the end view of the pessary component of the present invention;

[0021] Figs. 2, 2a-2c shows the graft of the kit of the present invention;

[0022] Figs. 3a - 3b show a graft placement component of the kit of the present invention;

[0023] Figs. 4a, 4b, 5a, 5b, 5c, 5d and 6 show the operation of the graft placement component of Fig. 3a having a bullet needle and thread of the graft of Fig. 2 attached thereto;

[0024] Figs. 7a -7d show an incision being made in the vaginal wall and the muscle and flesh pulled back and show the incision after the graft has been inserted and the incision has been sutured; and

[0025] Fig. 8 shows various parts of the anatomy with some components of the system of the present invention in place.

[0026] Fig. 9a shows a pictorial view of an alternative embodiment of the pessary of the present invention, being vaginally inserted.

[0027] Fig. 9b shows various parts of the anatomy with some components of the system of Fig. 9a in place.

[0028] Fig. 9c shows various parts of the anatomy with some components of the system of Fig. 9a in place, with the inflation tube removed.

[0029] Fig. 10 illustrates a post-surgical alternative embodiment of the graft, which has been placed into a patient.

[0030] Fig. 11 illustrates a post-surgical alternative embodiment of the graft, which has been placed into a patient that does not have a uterus. [0031] Fig. 12 illustrates a post-surgical alternative embodiment of the graft, which has been placed into a patient, wherein the wings have been affixed to the sacrospinous ligaments.

[0032] Fig. 13 shows an alternative embodiment of the graft of the present invention.

[0033] Fig. 14 shows an alternative embodiment of the graft of the present invention having wings and needle connecting segments attached thereto.

[0034] Fig. 15 shows an alternative embodiment of the graft of the present invention, and a tack weld located on a needle connecting segment.

[0035] In describing the preferred embodiment of the invention that is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. For example, the word "connected" or terms similar thereto are often used. They are not limited to direct connection but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art.

DESCRIPTION OF EMBODIMENTS

[0036] The present invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments described in detail in the following description.

[0037] 1. System Overview

[0038] This invention, which includes elements of a method and device, represents a novel way of treating vaginal wall prolapse. Prior art, as discussed above, is inadequate and limited by complexity of use, etc.

[0039] The present invention is a system that preferably includes a kit to overcome the above-mentioned limitations. The kit preferably has at least one main component: an optional inflatable post-operative pessary. The pessary shown in U.S. Patent No. 6,470, 890 (incorporated herein by reference) is similar. However, the present invention is a unique inflatable postoperative pessary device, shaped to mirror the shape of the vagina and to capitalize on surfaces of the vagina that will aid in retention. U.S. Pat. Pub. No. 2009/0326573, filed March 23, 2009 by the same inventor hereof, the entirety of which is expressly incorporated by reference herein, further discloses features and embodiments of this pessary. This invention may be a line extension of the traditional pessary device although here it acts as a vaginal splint during surgical healing (i.e., for keeping the mesh back as far as it will go). This splint could also be used non-surgically as a replacement for standard pessaries. Note Mentor and Milex make the majority of currently used pessaries. However, such prior art designs are fundamentally decades old and suffer from difficulty with insertion and retention. Moreover, the firm shapes of such previous pessaries create an increased probability of pressure sores on the vagina and are not used as postoperative vaginal splints for this reason.

[0040] In one preferred embodiment, the kit may also include a synthetic polypropylene mesh graft version that is similar to the mesh of the Pro lift™ system produced in a kit form by Ethicon, Inc. One patent associated with this system is for the specific graft used, that being a synthetic polypropylene mesh shown and described in U.S. Patent No. 6,638,284 which is herein incorporated by reference. Similar to the Prolift™ graft, the inventive graft is preferably designed to cover the entire vaginal vault and provide anchoring to the Arcus Tendineous and Sacrospinous Ligament. U.S. Pat. Pub. No. 2007/0173864, and U.S. Pat. Pub. No. 2009/0171 143, both of which are expressly and entirely incorporated by reference herein, further disclose features and embodiments of this graft.

[0041] Another component may be a graft placement component or delivery device. The inventive delivery device is preferred blade trocar similar to the ones illustrated in U.S. patent numbers mentioned above. For example, such a "Laurus TM„ or "Capio TM„ device may be a good predicate device for the delivery device component of this kit. The graft delivery device acts preferably as a suture-capturing device also but here the suture is a mesh wing.

[0042] Using the components described above, the inventive method includes the following steps: make an incision in the vaginal wall; open the incision to gain access inside the vagina and Pelvic Floor; take a suture-capturing device in hand; attach the mesh wing; insert the wing; push the wing through the ligaments; pull the wing back out the cut hole with the suture device; attach another wing; and repeat the process at another location within the vagina; repeat the process with the other wings until all of the wings are attached to commonly accepted apical and lateral support structures. These are generally the Sacrospinous Ligament and proximal Arcus tendineus. This tension-free wing securement allows the custom adjustment for each patient, which would not occur with suture fixation. The excess mesh wing material should then be trimmed away and discarded. After the remaining mesh is secured, the incision is closed, an inventive pessary device is then inserted into the vagina and inflated. The pessary holds the mesh in place and also allows healing to take place so that the mesh becomes embedded into the vaginal wall. The pessary preferably stays in place over a period of time, for example, three to ten days.

[0043] 2. Detailed Description of the Preferred Embodiments

[0044] As mentioned above, the system of the present invention in one embodiment is a kit preferably having main parts.

[0045] The first component is a pessary. As shown in Figs, la-lc, pessary 123 of the present invention preferably has a configuration designed to hold it in place within the vaginal cavity.

[0046] Further, while a limited number of inflatable pessaries are currently available, they are shaped in ways that reduce retention since they do not capitalize on the aspects of the vagina and pelvic floor muscles that could be used to increase retention in the vaginal vault. See, for example, W02004/045457 herein incorporated by reference. However, the inventive pessary component is constructed and shaped to overcome the limitations found in the prior art. See, e.g., Figs la-lc.

[0047] The inventive pessary further may have a bumpy or dimpled surface to aid in retention to the wall tissue. The pessary is preferably made of pliable material such as a soft polymer, e.g., rubber, a non-latex, or silicone. In one preferred embodiment, the pessary is preferably an inflatable pessary. The pessary is used as a splint after surgery to temporarily hold the mesh in place until it physically bonds to the interior vaginal wall. In one alternative embodiment the pessary may have a shape like that of a Gellhorn TM pessary, but instead of being made of a solid silicone it may be inflatable.

[0048] At the present time, pessaries are rarely used as a post-operative splint to help maintain the position of a vaginal surgical repair. Currently, surgeons most often use gauze packing for that purpose, which is significantly limited by the need to remove it after a short period of time and the relative discomfort associated with its use. The other significant limitation is that the packing compresses the urethra, reducing the patient's ability to void until it is removed.

[0049] Only Mentor has a pessary for surgical use called an "adjustable vaginal stent". However, this post-operative splint has fallen into disuse because its oblong tubular shape is inefficient for the dissimilarly shaped vagina and retention rates are poor as a result. Interest in splinting the vagina has been renewed because a graft reinforced vaginal repair creates a greater need to support the vagina during healing. These grafted procedures often utilize less tacking sutures and rely on the resistance to displacement of the material to maintain its position while healing. [0050] There has been some attempt to design pessaries to serve as a post-operative splint. However, design deficiencies cause the devices to be poorly retained if not sewn in or cause pressure spots and pain if the traditional shapes are used. This is primarily because they were designed without correct understanding of the actual shape of the vagina in a live ambulatory woman and a lack of understanding of the best retention points within the vaginal cavity. Recent use of MRI 3D reconstructed images has furthered understanding of these issues.

[0051] Further, prior art inflatable pessaries lack the properties of good retention because they fail to achieve a shape, which mirrors the shape of the vaginal cavity. They also fail to capitalize on the retention points created by the shape of the Levator Ani muscle as it surrounds the mid vagina.

[0052] The inventive pessary device 123 is novel in that the design is created to improve retention without increasing the pressure within the vagina. Being inflatable and appropriately shaped also allows it to evenly distribute the pressure of the vaginal walls. Rather than having the circular or symmetrically tubular shape of prior art, the pessary 123 possesses an arc to mirror the posterior axis deviation of the vagina and has a horizontally ovoid cross-sectional shape. In one embodiment, the shape resembles a mushroom or toggle bolt with a banana shaped axis. Such a shape allows the pessary to be better "captured" behind the Levator Ani within the midvagina.

[0053] The pessary 123 further has a first lobe 124, second lobe 125, a base 130, an inflation tubel32a, and an anchoring knob 137. Preferably, a slight central depression 136 is present to keep pressure off the surgical sites when used post-operatively. In use, the inflated lobes or flanges 124, 125 protrude from the midsection to lodge behind the Levator margin. The knob 137 is convex to elevate the anterior wall. The inflation access or tube 1 32a will protrude from a distal end and inflate with a standard inflation device. A variety of connectors could be added to it. Dimples or bumps 139 may also be present.

[0054] Figs. 9a-9c show various other configurations of the pessary 123. In Figs. 9a- 9c, e.g., the pessary 123 includes a base 130, an inflation tube 132a, an anchoring knob 137, and a shaft 135 that extends between and connects base 130 and anchoring knob 137. In use, any of base 130, shaft 135, and anchoring knob 137, optionally more than one or all or base 130, shaft 135, and anchoring knob 137 can be inflated by way of a standard inflation device, such as the illustrated bulb inflator.

[0055] There are several extensions to this use of this device 123. It is estimated that only a small fraction of patients with prolapse are operated upon. For a large number of patients, surgery is undesirable or not possible. The only alternative for those women is the traditional rigid pessary devices that are used in a small number of patients. Similar to the concerns with post-operative use, these devices are difficult to fit and are associated with uneven pressure distribution. There is an inflatable pessary (e.g., Inflatoball™ Milex, Inc.) that solves these dilemmas but its spherical shape makes retention more difficult. This inventive pessary 123 could be used in its place and would solve these problems with a design that aids retention without making insertion more difficult or cause skin irritation. One important aspect to this inventive design is that it allows a ventral protuberance to be fashioned under the urethra. This could be used for its ability to non-surgically treat urinary incontinence. Current pessaries that purport to treat stress incontinence with a ventral protuberance often fail because the circular shape fails to keep the position of the protuberance constant and it shifts away from the desired suburethral location.

[0056] The future uses of this pessary could be to evenly deliver therapies through its uniform contact with the vagina. Drugs or even electrical stimulation can be delivered transdermally through this device.

[0057] The next kit component is a preferably a graft. As best shown in Figs. 2 -2c, the mesh has a unique shape. Turning to Fig. 2, in this embodiment, the inventive graft here is a mesh 22 having protrusions referred to as arms, legs, and wings (or generally "wings"). The inventive mesh 22 preferably includes an upper portion 23, first edge 24, first optional wing 25a, second optional wing 25b, third wing 26a, and fourth wing 26b. Preferably, a first needle connecting segment 26c, a second needle connecting segment 26d, a central body portion 27, a first arm 27a, and a second arm 27b also make up the mesh 22. The mesh 22 may further include a lower portion 29, a first leg 29a, a second leg 29b, a third connecting segment 29c, a fourth connecting segment 29d, and a tail 29e. On each arm and leg respectively is preferably a first bullet needle 28a, second bullet needle 28b, third bullet needle 28c, and fourth bullet needle 28d. In another embodiment, wings 25 a and 25b are not present.

[0058] The inventive wings, legs, arms, etc. are intended to be used for attachment via the Arcus Tendineous near the Ischial Spine for the anterior vaginal wall and the Sacrospinous Ligament on the posterior vaginal wall. These anatomical structures are deep in the pelvis making them excellent for support but otherwise difficult to access without a special graft delivery device as will be described more fully below. However, once such a device reaches the preferred location, the device helps the surgeon to wedge the graft mesh into place. [0059] Figs. 2a-2c show various preferred configurations of the bullet needle and the leg or arm. In Fig. 2a, e.g., the bullet needle 28a is relatively small and generally round and is connected to the arm 26a via a thread or very thin segment of mesh, e.g., by second needle connecting segment 26c. In Fig. 2b, e.g., the bullet needle 128a is bigger (than 28a) and round and is connected to the arm 126a via segment of mesh 126a. In Fig 2c, e.g., the bullet needle 228a is bigger and flatter (than 28a and 128a) and is connected to the arm 226a via wider segment of mesh 226a. While the mesh 22 is preferably shaped as shown in Fig. 2, the mesh may be of any suitable shape and generally will incorporate a central body portion and at least two longitudinal side portions, e.g., arms. For example, the mesh of the present invention may be produced in a substantially oval shape or trapezium shape with extension arms and legs extending away from the central body portion of the mesh. The mesh is configured in this way so that it can be easily position over the pubocervical fascia and secured via the surrounding ligaments. Alternatively, the "needle" may be more densely formed mesh material. In such an embodiment, the small stainless steel needles may be replaced altogether. See, e.g., U.S. App. Pub. No. 2006/0052801.

[0060] The mesh material itself is preferably similar to the mesh material made by Boston Scientific Corporation called "POLYFORM™." Such a mesh is described in U.S. Patent Application Pub. No. 2005/0261545 incorporated herein by reference. There are many types of available mesh grafts such as the mesh described in PCT/US 02/31681 to Ethicon, also incorporated herein by reference. Nearly every medical device company has it's own patented mesh and any of them can be used for this procedure.

[0061] The mesh preferably includes a plurality of open pores bounded by strands made of non-woven polymeric material, for example, a polypropelene having monofilament fibers, wherein the junctions between the strands are without open interstices and the majority of open pores of the mesh have an area of less than 15 mm2. Preferably, the pore size has an area of less than 10 mm2. In the most preferred embodiments, the pore size of the central body portion of the mesh is greater than the pore size of the longitudinal side portions. The pore size range in these portions is preferably between 3 mm and 8 mm wide. The preferred mesh is also light and very flexible having a weight of less than .0080 g cm2. The materials and mesh arrangement are such so as to minimize the chance of infection after implant.

[0062] While any conventional prosthetic material currently used for the treatment of pelvic organ prolapse can be employed when performing the inventive method, there are many so-called biografts that can be used as well such as animal or human donor tissue or any other xenograft material such as pig dermis, allograft, or homograft of skin, while any of these materials are suitable for reinforcing the vaginal wall, a synthetic polyprolpylene mesh is preferred.

[0063] While the inventive wing, leg, or arm of the graft is preferably affixed to a relatively small rounded bullet needle, it is also preferably tapered to allow atraumatic passage of it through the tissue and promote gripping of the wider portion of the arm or leg to the surrounding tissue. Further, instead of using the needle method for attaching the graft mesh, it is also possible for the mesh to be attached by other fastening means. Such a fastening means including a medical adhesive or glue, microwave or radio frequency welding, staples, tacks, and a hook and loop type fastener.

[0064] The second component is the graft delivery device or placement component as shown in Figs. 3a- 6. One of the novel concepts in this invention is the adaptation of a previously patented suture-passing device for the graft delivery device, e.g., U.S. Pat. Nos. 5,364,408; 5,540,704; 5,458,609; 5,575,800; and 5,662,664. The modification of such a device allows the surgeon to use this device to pass the graft mesh's wings, e.g., the arms and legs, directly through the desired anchoring structures without have to traverse these pathways. Further, the inventive device itself is easier to use then the graft delivery devices currently in use in prolapse surgery. Therefore, the inventive device requires less skill to deliver the graft wings to their target location.

[0065] As mentioned, the inventive delivery device is preferably based in part on the "Capio TM„ device (see e.g., patent numbers above) which is sold by Boston Scientific. See also, e.g., U.S. Pat. App. Pub. No. 2006/0052801. The Capio™ device was originally patented as the Laurus™ device and is generally used elsewhere for suture passage in limited access cavities. The device is preferably a trocar capped by a curvilinear needle guide and deployable bullet needle that passes to a catch mechanism. A plunger at the other end of the device deploys it.

[0066] Detailed drawings of an illustrative embodiment of the invention are shown in Figs. 3a, 3b, 4a, 4b, 5a-d, and Fig. 6 wherein the graft delivery device 30 includes an outer housing 32, with finger grips 34a and 34b, and a deployment catch 36. The outer housing 32 is preferably made of injection molded plastic such as polycarbonate, as are many other of the components described herein. A deployment sleeve 38, slidably disposed within the outer housing 32, has a retention catch 40 and is attached to a pushrod 42, constructed for example, of stainless steel. A driver shaft 44 includes a button 46 and has a hole 48a, into which is bonded an elongate rigid shaft 50a. The rigid shaft 50a, which may be made of music wire, passes through outer housing ribs 52a, 52b, and 52c, terminates slidably disposed within a hollow cylinder 54a. The hollow cylinders 54a and 54b, preferably made from stainless hypodermic tubing, are held in recesses in the outer housing ribs 52b and 52c. An elongate flexible tubular member 56a, that may be made of polypropylene or other suitable material, is also slidably disposed within the hollow cylinder 54a. As shown in Fig. 6b, needle guide 58a may also be constructed from stainless hypodermic tubing, and has pivot pin 60a pivotally disposed within outer housing boss 62a. A driving link 64a is attached by a link pin 66 to the pushrod 42 and to the needle guide 58a by a pivot pin 68a, with the entire mechanism preferably made of stainless steel so as to maximize the biocompatibility as well as the strength of the actuating members.

[0067] Referring again to Figs. 3a and 3b, the device 30 has a driver retainer 70 that is slidably disposed within the outer housing 32, and is fixably attached to rigid shaft 50a, with a hole 72 to allow the pushrod 42 to pass slidably therethrough. A driver spring 74, preferably wound from stainless steel wire is compressed between the driver retainer 70 and the outer housing rib 52b. A deployment spring 76, also made of stainless steel wire is compressed between an end 77 of the deployment sleeve 38 and outer housing rib 52a. A needle catch 78a is housed within a recess 80a in the outer housing 32.

[0068] Referring now to Fig. 4b, a retraction line 82a that is preferably made of Kevlar, is slidably threaded through the flexible tubular member 56a and is attached to a needle carrier 84a by means of a crimp 86a or other means that would bind the retraction line 82a to the needle carrier 84a. The distal end of the retraction line 82a is attached to the rigid shaft 50a by means of another crimp 98a or other means. The needle carrier 84a is slidably disposed within the needle guide S8a, and holds a needle 88a (or e.g. bullet needle 28a), typically constructed of surgical grade stainless steel in a recess 90a, such needle having a suture 92a attached thereto. The suture material is preferably polyglycolic acid, but may be made of polypropylene, nylon, silk, catgut, or any other materials known in the art selected for their biocompatibility and tensile strength to be used in the body for the approximation of tissue. The suture 92a exits the needle guide 58a by means of a groove 94a and is stored in a recess 96 in outer housing 32. In one preferred embodiment, suture 92a would be, e.g., thread 26c which is connected to arm 26a as shown in Fig. 2.

[0069] Referring to Figs. 3b and 4b, arm 124 of deployment sleeve 38 is pushed so that the sleeve slides within the outer housing 32, compressing spring 76, and in tum sliding pushrod 42. When the pushrod 42 slides relative to the outer housing 32, driving link 64a, which is pivotally attached to both pushrod 42 and needle guide 58a, the pushrod forces the needle guide 58a to pivot about the pin 60a that is retained in outer housing boss 62a. [0070] One other embodiment of the present invention is shown in Figs. 5a, 5b, 5c, 5d, and 6. It should be again understood that in the interest of clarity only one half of the instrument is being shown. The other half is quite similar in function and structure as the half described herein. The upper portion of the device is similar in construction and materials to the previously disclosed embodiments, and is not repeated here.

[0071] A mesh placement device 196 includes an outer housing 198 having bosses 200 into which a pin 202 is rotatably inserted. The pin 202 is secured to an arm 204, which is attached to a needle carrier 206. A pin 208 on needle carrier 206 is rotatably inserted into a hole 210 in a link 212. Another pin 214 is secured to a pushrod 216 and is rotatably inserted into another hole 218 in the link 212. The pushrod 216 is attached to a sleeve 220 slidably disposed within the outer housing 198.

[0072] Fig. 6 shows a detail view of a needle 222 (similar to bullet needle 28a) held in a recess 224 in the needle carrier 206. A thread 226, like thread 26c, is attached to the needle 222 and is threaded through a slot 228 in the needle carrier 206. All components in this mechanism are preferably constructed of surgical grade stainless steel, chosen for its biocompatibility and strength.

[0073] 3. In Use

[0074] As mentioned above, there are specific anatomic structures, deep in the pelvis, typically used for graft fixation, which are chosen due to their advantageous location and resistance to displacement.

[0075] Nevertheless, because these structures are difficult to access, an incision must be made in the vaginal wall. See, e.g., Figs. 7a and 7d. Once the incision is made, a delivery device 30 is used to put the graft, e.g., 22 in place. The delivery device 30 uses a needle, e.g., 28a that can be affixed to each one of the mesh arms or legs, e.g. 26a. The needle and graft are loaded into a needle guide located on the delivery device. Preferably, once the mesh and the needle are loaded in the delivery device, the remainder of the body of the mesh with the remaining three arms and legs hang from the needle. After the appropriate dissection of the para vaginal tissue is made and the anchoring structures are located and cleared of any connective tissue, the delivery device is moved into place over the desired structure. The plunger is then compressed and the needle deployed. Once the needle and mesh pass through the desired anchoring structure, the entire device 30 is gently retracted out of the vagina. This leaves the ami or leg of the mesh loosely encircling the anchoring point. The delivery device is then again held in position to engage the subsequent needles from each of the remaining three needles passing each wing around its anchoring point. The mesh can be delivered as a single piece or cut into two separate pieces for delivery into the anterior and posterior wall of the vagina separately. Adjustment of the arm or leg then can take place. This is done by pulling the mesh as cephalad as need be and causing the mesh to lie flat in its respective compartment. The ends of each arm or leg are then cut to release the needle. The excess mesh and needle are then disposed of. After closing the vagina, the pessary 123 is then inserted into the vagina and inflated to an appropriate degree. See, e.g., one possible embodiment shown in Figs, la-lc. This accomplishes the goal of using the pessary to be retained in the vaginal wall and hold the mesh back into place. It does this while not being inflated to a degree that would impede blood flow or result in postoperative pain.

[0076] Turning now to Figs. 7a-7d, posterior vaginal wall (213) is shown with the epithelium (214) of the posterior vaginal wall in place. In one preferred method of the present invention, a longitudinal incision is performed in order to mobilize the epithelium (214) off the underlying fascia (215). Dissection is carried out medially to the Levator Ani muscles on each side. In the upper part of the vagina, dissection is continued in a lateral and cranial direction through the peri-rectal space on both sides towards the Sacrospinous ligaments on each side. This creates a safe space through which to deploy the device. The pre-shaped mesh graft, e.g. 216, is designed for the posterior vaginal wall repair. It is placed over the rectovaginal septum (215) with each extension arm (217,218) placed into the space extending from the posterior vaginal wall dissection to the Sacrospinous ligament. The positioning of one possible embodiment of the mesh (216) is more clearly depicted in Fig. 8, which shows its location relative to the Sacrospinous ligament (233), the rectum (234) and the vagina (235).

[0077] The preferred intra-vaginal splint or pessary 123 is shown in Figs, la-le. The splint is preferably a rubber or silicone membrane. In one embodiment, the membrane is twin skinned and is inflatable. Inflation of the membrane with fluid e.g., air, is possible through tube 132a that provides a fluid channel into the space between the respective layers of the membrane. Figs, la-lc shows a deflated intra-vaginal splint 123 preferably retained in the vagina before inflation. Like the embodiments shown in Figs, l a-l c, the embodiments of Figs. 9a-9c can have a twin skinned configuration which enables its inflation. Optionally, one or more of base 130, shaft 135, and anchoring knob 137, depending on the intended end-use configuration, is hollow which enables inflation of respective portions or the entirety of pessary 123.

[0078] After inflation, the splint 123 can stay three (3) or more days and up to a period of four (4) weeks. Once this period has elapsed, the splint 123 can be removed by deflating it. After this time, the synthetic mesh should have become incorporated into the tissue of each of the respective vaginal walls.

[0079] While the preferred embodiments and best modes of utilizing the present invention have been disclosed above, other variations are also possible. For example, the materials, shape and size of the components may be changed.

[0080] Additionally, the Uphold™ Vaginal Support System, which is sold by Boston Scientific, may constitute an illustrative embodiment. The Uphold™ Vaginal Support System constitutes an intra-vaginal approach to apical and anterior prolapse that utilized a small incision and mesh only where it is needed, designed to reduce the risk of erosion. The Uphold™ Vaginal Support System provides Level I and II support. To this point, loss of apical support is often involved with the occurrence of cystocele, and anterior wall descent occurrence is due to ATFP detachment from the ischial spine over 95% of the time. Accordingly, the mesh of the Uphold™ Vaginal Support System was designed to provide Level I support at the vaginal apex, while also providing Level II support where a concomitant cystocele may likely occur. In a retrospective study, anterior sacrospinous valut suspension was associated with increased vaginal length and apical suspension compared with posterior sacrospinous suspension. Accordingly, the Uphold™ Vaginal Support System provides an anterior sacrospinous option for apical prolapse, in that it was designed with an anterior sacrospinous approach to help improve vaginal depth. Furthermore, a retrospective study demonstrates that reducing the number and extent of vaginal incisions may reduce the risk of exposure. Accordingly, the Uphold™ Vaginal Support System offers a technique to avoid mesh overlapping the incision lines. Referring to Figs. I 0-15, Uphold™ Vaginal Support System procedural techniques were designed using a small incision, leaving approximately 2 centimeters undisturbed at the vaginal apex, to reduce the risk of erosion.

[0081] Referring to Fig. 10-15, the Uphold™ Vaginal Support System illustrates many of the features previously discussed herein. The mesh includes a pair of legs, each culminating in a "Capio" taper cut needle, which is well-known technology designed for efficient platement, a lead dilator transition, which opens the sacrospinous ligament to facilitate smooth passage of the leg into position; a mesh leg assembly, which automatically throws and places the mesh assembly in one step, adjustability of the mesh leg assembly is designed to provide precision control of mesh placement; a leader loop, which facilitates precise mesh leg placement; a tack weld, which holds the mesh leg within the sleeve; and a separator welds, which aids access to a single lead for efficient trimming and removal of the protective sleeve. The mesh further includes a center blue line, designed to improve visual orientation of the material.

[0082] The Uphold™ Vaginal Support System mesh assembly utilizes polyform mesh, which is made from uncoated monofilament macroporous polypropylene. This material has had a history of success in various parts of the body for over 30 years. The goal was to improve upon this well-known material, and make it soft, smooth, thin, and light with increased stretch compared to a leading synthetics mesh for pelvic organ prolapse. The Uphold™ Vaginal Support System is intended to be used in conjunction with the Capio® suture capturing device, which is designed to extend one's reach into deep, difficult-to-access cavities for precise placement within a small incision. Increased procedural control by eliminating the need for trocar passes, and offering a completely intra-vaginal approach is therefore achieved.

[0083] Various alternatives are contemplated as being within the scope of the following claims that particularly point out and distinctly claim subject matter regarded as the invention.

Claims

WHAT IS CLAIMED IS:
1. An apparatus for treatment of prolapse in a pelvic region of a patient, comprising; a graft having a central body;
at least one wing extending therefrom; and
a needle attached to a distal end of the wing, wherein the needle in configured for engagement with soft tissue proximate the pelvic region.
2. The apparatus of claim 1 further comprising a vaginal splint.
3. The apparatus of claim 2 wherein the vaginal splint comprises a pessary having an inflatable membrane.
4. The apparatus of claim 1 wherein the graft is comprised of stretchable material.
5. The apparatus of claim 4 wherein the graft is comprised of polypropylene.
6. The apparatus of claim 1 wherein the wing tapers frame the central body to the needle.
7. The apparatus of claim 5 further comprising a needle connecting segment connecting the needle to the central body.
8. The apparatus of claim I wherein the graft is comprised of a mesh material.
9. The apparatus of claim 1 wherein the needle is formed of stainless steel.
10. The apparatus of claim I further comprising a graft delivery device configured to place the needle at a desired anchoring point and anchor the needle to soft tissue proximate the pelvic region.
11. An apparatus for treatment of pelvic organ prolapse, comprising;
a graft having a central body;
at least two wings extending therefrom;
at least one needle connecting segment extending from the distal end of a wing; and a needle attached to the needle connecting segment; and
wherein the graft and the at least two wings are formed of deformable mesh.
12. The apparatus of claim 11 wherein the needle connecting segment tapers from the distal end of the wing to the proximal end of the needle.
13. The apparatus of claim 1 1 wherein the needle is made of stainless steel.
14. The apparatus of claim 1 1 further comprising a vaginal splint.
15. The apparatus of claim 14 wherein the vaginal split is made of an inflatable membrane.
16. The apparatus of claim 1 1 wherein the deformable mesh is made of propylene.
17. The apparatus of claim 1 1 wherein the deformable mesh is made of a mono filament polypropylene.
18. An apparatus for treatment of pelvic organ prolapse comprising;
a graft having a central body configured to provide suspension of a pelvic organ; at least two wings extending therefrom having a width and length configured for anchoring to respective portions of the sacrospinous ligament;
at least one lead extending from the distal end of each wing;
a needle attached to each lead, wherein the leads taper from respective distal ends of the wings to respective proximal ends of the needles; and
a graft delivery apparatus configured for intra-pelvic graft delivery and suture capture with an external deployment apparatus.
19. The apparatus of claim 18 further comprising a vaginal splint.
20. The apparatus of claim 19 wherein the vaginal splint comprises a pessary having an inflatable membrane.
PCT/US2014/066362 2009-10-13 2014-11-19 Apparatus for treating vaginal prolapse WO2015077310A1 (en)

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