WO2024145529A1

WO2024145529A1 - Devices for the treatment of fistulas

Info

Publication number: WO2024145529A1
Application number: PCT/US2023/086317
Authority: WO
Inventors: Abram D. Janis; Elizabeth M. STARCK; Irina Y. CHENG; Julia Sheridan SCHMULEWITZ; Ria M. DESAI; Timothy Jisuk HONG; David P. O'NEILL; Jeffrey BLIBO
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2022-12-29
Filing date: 2023-12-28
Publication date: 2024-07-04
Anticipated expiration: 2025-06-29
Also published as: EP4642341A1

Abstract

Vaginal fistula repair products for vesicovaginal fistulas and rectovaginal fistulas. The products includes sleeves, plugs and/or drainage devices.

Description

DEVICES FOR THE TREAMENT OF FISTULAS

FIELD OF DISCLOSURE

[0001] The present disclosure is generally directed to devices, products, and methods for the treatment of fistulas and, more particularly, alleviating incontinence symptoms associated with vaginal fistulas. The present disclosure is also directed to vaginal fistula devices that may be patient-operated or clinically deployed and prevent or treat urinary or fecal leakage from the vaginal canal.

BACKGROUND

[0002] A fistula is an abnormal opening or connection between two body parts. A vaginal fistula is an abnormal opening that forms between the wall of the vagina and another organ. Common types of vaginal fistulas are vesicovaginal fistulas (between the vaginal wall and the bladder) and rectovaginal fistulas (between the vaginal wall and the rectum or colon). Vesicovaginal fistulas result in urine leaking out of the vagina, and rectovaginal fistulas result in fecal matter leaking out of the vagina. [0003] Vaginal fistulas caused by childbirth are referred to as obstetric fistulas. Such fistulas are typically caused by obstructed labor, resulting in abnormal communication between the vagina and neighboring organs, usually the bladder (vesicovaginal) or rectum (rectovaginal). It is estimated that more than 2 million individuals globally are affected, with around 100,000 new cases annually. The primary treatment for a vaginal fistula is surgery. However, the relatively high cost of the procedure and the inaccessibility of surgical clinics may render surgery impossible for many women in low-resource environments. Surgery also may be delayed while inflammation and/or infection at the injury site resolves.

[0004] Accordingly, there remains a need for solutions, and in particular non- surgical solutions, to help alleviate urinary and fecal incontinence symptoms for women with vaginal fistulas.

SUMMARY

[0005] In one aspect, a product for treating vaginal fistulas includes an inflatable member having an outer surface and an inner surface. The inner surface defining an inflation cavity. The inflatable member has an initial inverted configuration and an inflated deployed configuration. The product also includes a liner for covering fistulas associated with the outer surface of the inflatable member, the liner being releasable from the outer surface. During inflation, the inflatable member everts, moving from the initial inverted configuration to the deployed inflated configuration within a vagina. When in the deployed inflated configuration, the inflatable member is configured to deploy the liner over a fistula in a vaginal wall of the vagina.

[0006] In another aspect, a product for treating vaginal fistulas includes a cup shaped and sized to be placed in a vagina below a fistula. The cup is configured to collect fluid leaking from a fistula.

[0007] In another aspect, a product for treating vaginal fistulas includes a head shaped and sized to be placed in a vagina below a fistula, the head include of an absorbent material that is configured to collect fluid leaking from a fistula.

[0008] In another aspect, a product for treating vaginal fistulas includes a vaginal catheter comprising a housing having a wall, wherein at least a portion of the wall is a permeable portion, and a vacuum device operatively connected to the housing for creating a vacuum with the housing to pull fluid into the housing.

[0009] In another aspect, a product for treating vaginal fistulas includes a plug sized and configured to seal the fistula.

BRIEF DESCRIPTION OF DRAWINGS

[0010] Fig. 1 is a schematic illustration of the female pelvic region, showing a liner of a fistula treatment product of the present disclosure within a vagina.

[0011] Fig. 2a is a perspective view of one embodiment of a liner in accordance with the present disclosure.

[0012] Fig. 2b is a perspective view of another embodiment of a liner in accordance with the present disclosure.

[0013] Fig. 2c is a perspective view of another embodiment of a liner in accordance with the present disclosure.

[0014] Fig. 2d is a perspective view of another embodiment of a liner in accordance with the present disclosure.

[0015] Fig. 3 is a perspective view of one embodiment of a fistula treatment product in accordance with the present disclosure.

[0016] Fig. 4 is a cross-sectional view of one embodiment of an inflatable member and liner of the product shown in Fig. 3.

[0017] Fig. 5a is a cross-sectional view of the product of Fig. 3, shown in the initial inverted configuration. [0018] Fig. 5b is a cross-sectional view of the product of Fig. 3, shown in transition from the initial configuration to the inflated configuring and with the inflatable member and liner everting out of the housing.

[0019] Fig. 6 is a cross-sectional view of the product of Fig. 3, shown in the deployed inflated configuration.

[0020] Fig. 7 is a cross-sectional view of another embodiment of the product in accordance with the present disclosure.

[0021] Figs. 8a-8c are schematic illustrations showing the deployment of the liner into the vagina using the device shown in Fig. 3.

[0022] Fig. 9 is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure.

[0023] Fig. 10 is a schematic illustration showing the fistula treatment device of Fig. 9 positioned within the vagina.

[0024] Fig. 10a is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure positioned within a vagina.

[0025] Fig. 11 is a side view of another embodiment of a fistula treatment device in accordance with the present disclosure.

[0026] Fig. 12a is a cross-sectional view of the device of Fig. 11 , shown with a film covering the inner and outer surfaces.

[0027] Fig. 12b is a cross-sectional view of an alternative embodiment of the device of Fig. 11 , shown with a film covering the inner surface.

[0028] Figs. 13a and 13b are schematic illustrations showing the deployment of the device into the vagina using the device shown in Fig. 11 .

[0029] Fig. 14 is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure.

[0030] Fig. 15 is a schematic illustration showing the device positioned in the vagina.

[0031] Fig. 16 is a schematic illustration showing another embodiment of a fistula treatment device in accordance with the present disclosure.

[0032] Fig. 17 is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure.

[0033] Fig. 18 is a side view of the catheter of the device shown in Fig. 17.

[0034] Fig. 19 is a cross-sectional view of the catheter shown in Fig. 18. [0035] Fig. 20 is a schematic illustration showing the device positioned in the vagina.

[0036] Fig. 21 is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure.

[0037] Fig. 22 is a partial cross-sectional view of the device shown in Fig. 21 . [0038] Fig. 23 is a schematic illustration showing the device positioned in the vagina.

[0039] Fig. 23a is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure.

[0040] Fig. 24 is a schematic illustration showing another embodiment of a fistula treatment device positioned in the vagina.

[0041 ] Fig. 25 is a perspective view of the device being deployed.

[0042] Fig. 26 is a perspective view of the device being withdrawn.

[0043] Fig. 27 is a schematic illustration showing an anchor for holding the device of Fig. 24 in the vagina.

[0044] Fig. 28 is a schematic illustration of the device of Fig. 24 attached to the anchor.

[0045] Fig. 29 is a perspective view of another embodiment of a fistula treatment device in accordance with the present disclosure.

DETAILED DESCRIPTION

[0046] A more detailed description of the devices, products, and methods in accordance with the present disclosure is set forth below. It should be understood that the description of the specific devices below is intended to be exemplary, and not exhaustive of all possible variations or applications. Thus, the scope of the disclosure is not intended to be limiting and should be understood to encompass variations or embodiments that would occur to persons of ordinary skill.

[0047] The devices, products, and methods disclosed herein may serve as a bridge between injury and surgery to repair the vaginal fistula. Alternatively, they may be used for long-term treatment to allow the patient to control their incontinence and prolong the period they can forgo surgery. In yet another alternative where surgery is not feasible, these devices can act as an alternative that improves the quality of life by effectively managing incontinence. [0048] Fig. 1 is a schematic illustration of the anatomy of the female pelvic region and shows one embodiment of a fistula treatment product 10. The female pelvic area includes the bladder 12, urethra 14, cervix 16, uterus 18, rectum 20, and vagina 22. In this figure, there is a vesicovaginal fistula 24 between the vaginal wall 26 and the urethra 14 or bladder 12. There is also a rectovaginal fistula 28 between the vaginal wall 26 and the rectum 20 or colon. It will be understood that fistulas 24 and 28 are shown for illustrative purposes, that a patient may have one or both types of fistulas, and that there may be multiple fistulas of either type. It will also be understood that the device, products, and methods disclosed herein may be used to treat any fistula in the vaginal region or any other region of the body. [0049] Product 10 is or includes a liner 30 that is positioned in contact with wall 26 of vagina 22 and covers and/or substantially seals fistulas. In the embodiment illustrated in Fig. 1 , liner 30 covers and/or substantially seals fistulas 24 and 28. Liner 30 may have a variety of shapes and sizes. Turning to Fig. 2a, in one alternative, liner 30 may be a sleeve or tube. Liner 30 has a proximal end 32, a distal end 34, and a passageway 36 therethrough. In Fig. 2b, liner 30a has the shape of an elongated strip. In Fig. 2c, liner 30b is a rectangular patch, and in Fig. 2d, the liner 30c is a round patch. Liners 30-30c may generally be referred to herein as liner 30.

[0050] Liner 30 may adhere to wall 26 of the vagina 22 and/or be biased against wall 26. For example, liner 30 may be made from a material that inherently exhibits adhesive properties or may include an adhesive applied to the surface 35 of the liner 30 that is adhered to vaginal wall 26. In one alternative, liner 30 may be made from hydrogels with inherent adhesive properties. Such hydrogels may include gelatin methacrylate hydrogels, alginate-boronic acid hydrogels, cellulose, and cellulose derivatives. In one embodiment, the hydrogel may be made from hydroxypropylmethyl cellulose (HPMC). In other alternative embodiments, liner 30 may be made from a hydrogel with an adhesive additive, such as a hydrogel with a chitosan additive or thermoreversible hydrogels with formulations that include thermoreversible gel with a combination of poloxamer Lutrol F 127, bioadhesive product Carbopol 5984, with a preservative such as sodium methyl parahydrobenzoate or sodium propyl parahydrobenzoate, and a neutralizer such as sodium hydroxide. In yet other alternatives, the liner 30 may be any suitable polymer material that is inherently adhesive or includes an adhesive coating on the outer surface or surface that contacts the vaginal wall 26. In one alternative, the liner may be made from a material or include an additive, wherein the adhesive characteristics are activated as liner 30 is applied to vaginal wall 26. For example, a material wherein wetting the material activates the adhesive characteristics. When the liner contacts the vaginal wall and bodily fluids associated with the vagina, the adhesive characteristics are activated.

[0051] In yet other alternatives, liner 30 may have a size and shape that biases or forces the liner 30 against vaginal wall 26. For example, when liner 30 is a sleeve, it may have dimensions slightly larger than the vaginal canal so that the liner is biased against the wall.

[0052] Figs. 3-6 illustrate an example of a fistula treatment product 38 that deploys liner 30 into the vagina to cover or substantially seal a fistula(s). Product 38 includes an inflatable member 40 with an initial inverted configuration (Fig. 3). That is, the inflatable member 40 is turned inside out. In the deployed inflated configuration shown in Fig. 6, inflatable member 40 has an inner surface 42 that defines an inflation cavity 44 (Fig. 6) and an outer surface 46. To provide consistency in the product’s description, the terms inner surface and outer surface of the inflatable member 40 are used to reference these surfaces regardless of the inflatable member’s configuration. Liner 30 is associated with the outer surface 46 of inflatable member 40. Liner 30 may be any of the above-discussed liners. In the embodiment illustrated in Figs. 3-6, liner 30 is shown as a sleeve. However, liner 30 may be an elongated strip or patch, as described above. Liner 30 may be applied to the outer surface 46 of the inflatable member 40 in any suitable manner. For example, liner 30 may be fitted over inflatable member 40 or dip-coated, sprayed, or painted on the outer surface 46 of the inflatable member 40.

[0053] Referring to Fig. 6, inflatable member 40 is shown in a deployed inflated configuration. In the deployed inflated configuration, inflatable member 40 is generally cylindrically shaped and has a proximal end 48, a distal end 50, and a longitudinal axis A extending between the proximal and distal ends 48, 50. Generally cylindrically shaped means that inflatable member 40 may have the shape of a right cylinder, the side may have a slight taper, or the inflatable member 40 may be slightly cone-shaped or truncated-cone-shaped. The length L of inflatable member 40 in the deployed inflated configuration between proximal end 48 and distal end 50 may be a length selected to suit the anatomy of the user and/or the location of the fistula within the vagina. In one alternative, the length L may range from about 7 cm to about 17 cm. In another alternative, the length L may be from about 8.2 cm to about 10.6 cm, and in yet another alternative, the length L may be about 9.5 cm. Additionally, the outer cross-sectional width or diameter D of inflatable member 40 in the deployed inflated configuration may range from about 18 mm to about 70 mm. In one alternative, the outer cross-sectional width may be about 30 mm.

[0054] Inflatable member 40 may have any variety of shapes and sizes in the initial configuration. Inflatable member 40 may be made from any suitable material. In one alternative, inflatable member 40 may be made from a suitable compliant material. In one example, the complaint material may be able to stretch 100% to 800% of its initial size. This allows the inflatable member to fully fill the space within the vagina and conform to the shape of the vagina. The compliant material may be, for example, a silicone or polyurethane material. In another alternative, the inflatable member 40 is made from a non-compliant or semi-compliant material that may be inflated to selected dimensions, such as selected lengths and cross-sectional widths, but is prevented or resists expanding beyond the selected dimensions by the constraints of the material. Such materials may include, for example, nylon, polyester, or PEBAX. In yet another alternative, inflatable member 40 may be made from both a compliant and a non/semi-compliant material to provide directional inflation. For example, the proximal and distal ends of inflatable member 40 may be made from non/semi-compliant materials, and the middle may be made from a compliant material. Alternatively, inflatable member 40 may include alternating compliant and non/semi-compliant segments.

[0055] Product 38 also may include an applicator 52 for inserting and/or positioning the inflatable member 40 and liner 30 into the vagina. Applicator 52 includes a body or housing 54 with at least one wall 56 that defines an internal compartment 58. Housing 54 includes a proximal end 60 and a distal end 62. Referring to Figs. 3 and 6, the distal end 50 of inflatable member 40 is operatively attached to the proximal end 60 of housing 54 so that inflation cavity 44 (Fig. 6) is in fluid communication with internal compartment 58. Also, inflation member 40, in the initial inverted configuration (Figs. 3 and 5), is located within internal compartment 58. As shown in Figs. 3 and 5, proximal end 48 of inflation member is located within internal compartment 58. [0056] Product 38 includes an inflation device 64 that delivers fluid into the internal compartment 58 of the housing 54. The fluid delivered into internal compartment 58 increases the pressure with internal compartment 58 and inflation cavity 44 of inflatable member 40 to deploy the inflatable member. Inflation device 64 is fluid communication with internal compartment 58. For example, a conduit 66 may fluidly connect inflation device 64 and internal compartment 58. In the illustrated embodiment, the inflation device 64 is a bulb pump, wherein one end of conduit 66 is connected to the bulb pump, and the other is connected to the distal end 62 of housing 54. The bulb pump may pump/deliver ambient gas (air) into the internal compartment 58/inflation cavity 44. Fig. 7 illustrates another embodiment of a product 38a wherein inflation device 64a is a syringe. The syringe may deliver a gas or a liquid into compartment 58a/inflation cavity. Accordingly, the fluid delivered into compartment 58/inflation cavity 44 may be a liquid or gas.

[0057] Still referring to Fig. 7, optionally, products 38 and 38a may also include a pressure sensor 68 for monitoring the pressure within internal compartment 58, 58a/inf lation cavity 44. Pressure sensor 68 may be used with any of the embodiments disclosed herein. The pressure within internal compartment 58 of housing 54 and inflation cavity 44 of inflatable member 40 should be sufficient to deploy inflatable member 40 out of housing 54 and apply liner 30 to the vaginal wall. However, the pressure should be limited so as not to cause injury to the vaginal wall. In one embodiment, the pressure within inflation cavity 44 does not exceed 232 kPa, and preferably does not exceed 26 kPa. In one embodiment, the pressure within inflation cavity 44 is 6.67 kPa to 232 kPa, or 6.67 kPa to 26 kPa, or 6.67 kPa and 13 kPa. In another alternative, the inflation pressure may be 6.67 kPa. In other embodiments, the pressure limit within inflation cavity 44 may be selected for the particular application.

[0058] Optionally, inflatable member 40 and housing 54 may be a unitary construct not intended to be separated by the user. In another alternative, inflatable member 40 and housing 54 may be detachable from one another, wherein inflatable member 40 is a single-use, disposable assembly or component, and housing 54 is a durable assembly or component. The housing may be made from, for example, polypropylene or Acrylonitrile-Butadiene-Styrene (ABS). In this alternative, inflatable member 40 may have a coupling (not shown) that is screwed or snap-fit with housing 54. Also, the user may be supplied with a plurality of inflatable members 40 having liners thereon or with new inflatable members 40/liners 30 on a periodic schedule or as needed to re-apply a liner.

[0059] Figs. 8a-8c illustrate the use of product 38. Referring to Fig. 8a, inflatable member 40, with liner 30 thereon, is in the initial inverted configuration and located in compartment 58 of housing 54 (Fig. 5). The proximal end 60 of housing 54 is inserted into the vaginal canal of vagina 22. Optionally, housing 54 may include a shoulder or a stop 70 that aids in inserting housing 54 to a desired depth and/or reduces the risk of over-insertion. When shoulder 70 is present, housing 54 is inserted until the shoulder contacts the area around the vaginal opening.

[0060] Referring to Figs. 8b and 8c, inflation device 64 is activated to deliver fluid into the internal compartment 58/inflation cavity 44 (Fig. 6). The pressure forces inflatable member 40 to inflate. As inflatable member 40 inflates, it everts and exits out of housing 54. As inflatable member 40 exits out of housing 54 and into the vagina 22, the outer surface of inflatable member 40 places or forces liner 30 into contact with the vaginal wall 26. For example, as inflatable member 40 evert and extends along the vaginal canal, inflatable member 40 lines at least a portion of the vaginal wall 26 with liner 30. When liner 30 is a sleeve, inflatable member 40 circumferentially lines the vaginal wall 26. When liner 30 is a strip or patch, inflatable member 40 lines a selected portion of the vaginal wall 26 having a fistula 24, 28. Whether the liner is a sleeve, strip, or patch, the liner covers and/or substantially seals the fistula to prevent or reduce the amount of bodily fluids and other bodily matter from flowing through the fistula.

[0061] When a pressure sensor 68 (Fig. 7) is present, the user may monitor the pressure. The user may stop the delivery of fluid when the pressure reaches a selected pressure or limit. Optionally, housing 54 may include a pressure relief valve that relieves pressure if the pressure exceeds a selected limit.

[0062] Liner 30 adheres to wall vaginal wall 26 or is otherwise held against the wall to cover and/or substantially seal the fistula 24. 28. For example, when liner 30 is or includes an adhesive, the liner adheres to the vaginal wall 26. In another embodiment, the dimensions of liner 30 may be such that it is biased against wall 26. After the liner 30 has been applied to the vaginal wall 26, inflatable member 40 is moved to a deflated configuration and removed from the vagina. That is, the inflatable member is deflated and removed, leaving the liner in place, as shown in Fig. 1 . In one example, the internal compartment of housing 54 is placed in fluid communication with ambient pressure. In one alternative, the housing 54 includes a resealable opening that is opened to deflate the inflatable member. In another alternative, the conduit 66 or inflation device 64 is detached from housing 54.

[0063] In some instances, the reapplication of a new sleeve may be required. The timing of reapplication will depend on various considerations, such as the material of the sleeve, the adhesive used, etc.

[0064] Insertable Drainage Product

[0065] Figs. 9 and 10 illustrate another embodiment of a fistula treatment product 100, which includes a wall 102 that defines a cup 104 that is shaped and sized to be inserted and retained within vagina 22. Wall 102 is made from a resilient material that may be folded or bunched up for insertion into the opening of vagina 22. After product 100 is inserted into vagina 22, it springs open towards its original shape, forming a seal against vaginal wall 26. The rim 106 of cup 104 may contact the vaginal wall 26 and be maintained in vagina 22 by friction fit with the vaginal wall. In one alternative, the cup 104 or rim 106 of cup 104 may have a size slightly larger than the vaginal canal of vagina 22. The pressure of vaginal wall 26 against cup 104 retains product 100 in vagina 22. In one embodiment, the cup’s dimensions may be a length of 40.00 mm to 78.60 mm and a width of 39.00 mm to 48.70 mm. In one alternative, the firmness of the cup could be 3.39 N to 13.92 N. The device may be suitable for staying in the vaginal canal for 4-12 hours. For removal, base 108 of cup 104 is pinched, and product 100 is moved gently from side to side while pulling down. The materials of cup 104 may include silicone, thermoplastic elastomer, natural rubber, etc. The material of product 100 and/or components of product 100 may be selected to last up to 10 years.

[0066] When inserted into vagina 22, cup 104 is located below the fistulas 24 and 28, and the cup includes a cavity that collects fluids leaking through the fistulas. The volume of cup 104 may be 18.18 ml to 34.34 ml. As shown in Fig. 9, in one embodiment, product 100 may have a drainage port 110. A tubing 112 may be connected to port 110 to drain fluid from product 100. Furthermore, port 110 and/or tubing 112 may include a valve. In one embodiment, wherein tubing 112 is periodically attached to port 110 for drainage, port 110 may have a cap or a valve. In one embodiment, the valve may be a pinch valve. In another embodiment, the valve may be a needless connector-type valve that opens when tubing or drainage tube 112 is attached. In one embodiment, the tubing 112 may be a short tube connectable/attachable to port 110 to allow for periodic drainage from the cup.

[0067] Drainage port 110 may be in fluid communication with a collection bag (not shown) that collects fluids from cup 104. For example, tubing 112 may be a longer tube connected to a collection bag. In this embodiment, tubing 112 stays connected to port 110 the entire time product 100 is worn. Fluids collected in cup 104 constantly drain into the collection bag, which may be a wearable pouch. The collection bag could then be emptied at a later time.

[0068] Fig. 10a illustrates another insertable drainage product 114 with a head 116 made of a flexible absorbent material. The absorbent material may be a sponge. Head 116 may be a sponge material that, optionally, has a liquid impervious skin 118 on the outer surface. Product 114 is located in the vagina below the fistula. The absorbent material absorbs liquid leaking from fistula 28. Optionally, head 116 may include a central passageway 120 for the passage of solids. Similar to product 100, product 114 includes a port 122 and, optionally a valve, that may be connected to a tubing for drainage.

[0069] Covered Stent

[0070] Figs. 11 and 12a-b illustrate another embodiment of product 130 for treating fistulas. Product 130 includes a scaffold 132 covered or surrounded by a film or a sleeve 134. Scaffold 132 may be a stent or mesh member made from a metal, such as stainless steel or nitinol. The scaffold 132 is in the shape of a tube with a passageway therethrough. The scaffold 132 has an inner and outer surface. In the embodiment shown in Fig. 12a, the film 134 covers the inner and outer surfaces of the scaffold 132. In Fig. 12b, the film 134 covers the outer surface of the scaffold. [0071] Turning to Figs. 13a and 13b, product 130 is inserted into vagina 22 so that it lines the vaginal wall to seal off fistulas 24 and 28. The implantation of product 130 may be facilitated by a delivery device 136, which may be similar to a tampon applicator. Product 130 is compressed inside the barrel 138 of delivery device 136 and will self-expand within the vagina 22 as the product 130 is pushed out of the applicator.

[0072] In one alternative, product 130 lines the entire vaginal canal to seal off fistulas 24 and 28, regardless of the location of the fistula along vaginal wall 26. This reduces the need for diagnostic technology to determine the precise location of the fistula 24 and 28, which may be especially advantageous in low-resource areas. In one embodiment, product 130 may have a length of about 63 mm and a diameter of about 30 mm. The shape of product 130 may be generally cylindrical. In other embodiments, the ends of the cylinder may taper inward or outward. In another embodiment, the shape may generally conform to the shape of the user’s vaginal canal.

[0073] Product 130 may be permanent or temporary. In the situations where product 130 is permanent, once implanted, the product would remain in the vaginal canal permanently and allow for the growth of new tissue around the fistula 24 and 28 to heal the fistula over time. Product 130 may include an anti-inflammatory or antibacterial and a regenerative aid. The anti-inflammatory or antibacterial may be incorporated into the sleeve or film covering the scaffold or a coating on the sleeve or film. Product 130 may also include a natural, biological material to serve as a scaffold for tissue growth in the injured region or a biodegradable scaffold to serve a similar purpose.

[0074] When product 130 is designed for temporary implantation, the scaffold may be made from silicone or acrylic. Products may be designed to be used only for a certain number of hours per day. For example, product 130 may be used for 4-5 hours per day for two weeks. The user may perform insertion, removal, and cleaning. [0075] Fistula Plug

[0076] Fig. 14 illustrates another embodiment of a product 140 for treating fistulas. Product 140 may be a fistula plug 142 with a first end 144, a second end 146, and a middle section 148. The first and second ends 144, 146 are larger in diameter or cross-section width than the middle section 148. In the illustrated embodiment, plug 142 has a barbell-like shape. Additionally, plug 142 may be a solid plug or in the form of microgels or bio-adhesives. In one embodiment, plug 142 may be made from a lyophilized, or freeze-dried, porcine small intestinal submucosa due. Such material may have inherently biocompatible properties, such as resistance to infection, no generation of foreign body or giant cell reaction, and the ability to be repopulated by host cell tissue over time.

[0077] In one embodiment, one or more ends 144, 146 of plug 142 may be conically shaped. The conical-shaped ends may provide added mechanical stability in the rectum where high pressures keep the plug in the proper position. This avoids dislodgement during strain, making this a more permanent and long-term alternative. [0078] Turning to Fig. 15, the plugs 142 are implanted by inserting one of the ends 144, 146 through the fistula 24, 28 so that the middle section 148 is located in the fistula 24, 28. One end 144, 146 is located in the vagina, and the other end 144, 146 is located in the other organ (e.g., urethra, rectum, etc.). The larger ends 144, 146 contact the tissue to hold plug 142 in place. Optionally, product 140 may include sutures 150 for holding plug 142 in place. A Seton Guide may be used to guide the plug into place and suture the plug to tissue.

[0079] When plug 142 is made from a bioabsorbable synthetic material, it may be made from a polymer-based prosthetic material, such as polyglycolic acid/trimethylene carbonate, that undergoes hydrolytic and enzymatic degradation, resulting in the plug being gradually absorbed by the body.

[0080] Referring to Fig. 16, in another alternative, the fistula plug 152 is formed from an injection of the water-immiscible, mussel protein-based bio-adhesive (WIMBA), wherein the bio-adhesive closes the fistula 28. This bio-adhesive involves the formation of a coacervate formed by combining the bioengineered mussel adhesive protein solution with the catechol-conjugated hyaluronic acid. In one embodiment, the catechol-conjugated hyaluronic acid is synthesized by conjugating dopamine hydrochloride or dihydroxyphenylalanine (Dopa) to hyaluronic acid through a carbodiimide coupling reaction, which increases surface adhesion strength and inter/intramolecular cohesion of WIMBA (imWIMBA). This imWIMBA resists being dissolved in urine or blood and has relatively greater stability in adhesion in the presence of bodily fluids and a greater rate of curing or healing. The addition of NalO₄ facilitates the oxidation of catechol moieties, leading to the solidification of the liquid adhesives, forming plug 152 through covalent crosslinking. In one embodiment, plug 152, made from the modified WIMBA, may have a storage modulus of about 7200 Pa, which allows for more significant stress caused by muscle contractions and movement along the area. Plug 152, made from the imWIMBA, is also biodegradable, allowing the fistula to heal naturally. It also reduces inflammation or immune response from the foreign substance and does not require a surgical procedure like suturing. Instead, an injection device 154 is used to deploy the plug material at the site of the fistula 28. The plug may also be used to plug a fistula between the bladder and vaginal tract. The injection device 154 may include a thin syringe needle 156. [0081] In another alternative fistula plug 152, the plug utilizes cryogel microparticles, or microgels, as the filling material. Cryogels can be challenging to adapt to the varied structure of fistulas, but the use of microparticles allows for the maintenance of macroscopic hydrogel properties such as good elasticity along with microparticle properties such as shear-thinning behavior.

[0082] The plug 152 may utilize polyethylene glycol diacrylate (PEGDA) crosslinked with biodegradable disulfide bond N, N’-bis (acryloyl) cysteamine (BAG) where they undergo cryogelation. Dopamine may be utilized to create nano silver (AgNPs) in situ on the coating surface, which is useful for its antibacterial properties. The cryogel is then broken up through mechanical fragmentation into microgels, which undergo reassembly into a solid form via self-healing. These microgels may have shear-thinning, self-healing, and sol-gel reversible transitions with excellent yield strength along with anti-infective.

[0083] Vacuum Drainage Device

[0084] Figs. 17-20 illustrate another product 170 for treating fistulas. Product 170 is a vacuum device that suctions urine and/or fecal matter from the vagina 22.

Referring to Figs. 17-19, product 170 includes a vaginal catheter 172 with a proximal end 174 and a distal end 176. Vaginal catheter 172 includes a wall 178 that defines an internal cavity 180. At least a portion 182 of the wall is a permeable portion made from a permeable material that allows the passage of urine and/or fecal matter. Portion 182 of wall 178, made from permeable material, communicates with internal cavity 180 and allows passage of urine and/or fecal matter from outside catheter 172 to internal cavity 180. The permeable portion may be a permeable material or, optionally, may include drainage eyelets or holes 183 through the material. Distal end 176 includes a port 184 in communication with internal cavity 180.

[0085] Product 170 also includes a vacuum device 186 that is operatively connected to catheter 172. Vacuum device 186 applies a suction force to internal cavity 180 of catheter 172. In the illustrated embodiment, a fluid conduit 188 connects vacuum device 186 to port 184. The suction force via conduit 188 creates a vacuum within internal cavity 180 of catheter 172. The vacuum within cavity 180 pulls fluids (e.g., urine, fecal matter, etc.) from outside catheter 172 through portion 182 of the wall 178 into cavity 180. The section force pulls the fluids in internal cavity 180 through conduit 188 and into vacuum device 186. Vacuum device 186 may include a collection container 190 that collects the fluids. [0086] Turning to Fig. 20, in one embodiment, catheter 172 is inserted into vagina 22 and the permeable portion 182 towards or against a fistula, such as fistulas 24 and 28. In the illustrated embodiment, permeable portion 182 is shown facing and/or against fistula 28. Of course, permeable portion 182 may be placed toward or against fistula 24. In other embodiments, the catheter 172 may be rotated during use to face or be placed against two or more fistulas. For example, catheter 172 may be rotated from the position shown in Fig. 20 to place the permeable portion against fistula 24. During use the catheter 172 may be rotated or placed . Alternatively, catheter 172 may be an external catheter that is placed against the vaginal opening, with the permeable portion 182 facing the vaginal opening. The vacuum device is activated to create suction and remove fluids from the vagina 22 as described above. In some embodiments, catheter 172 is adhered to the patient and will be connected to a small, relatively vacuum device and discrete collection container. Catheter 172 may be held in place by a belt that wraps around the patient’s waist and holds the catheter in place. In another embodiment, catheter 172 may be attached to wings or flaps that wrap around the patient’s undergarment (similar to a menstrual pad) to hold the catheter in place.

[0087] Other Fistula Treatment Products

[0088] Figs. 21 -23a illustrate further embodiments of products 200 (Fig. 21 ) and 200a (Fig. 23a). Product 200 includes a housing 202 with a proximal end 204, distal end 206, and a middle section 208. Housing 202 defines an internal cavity 210 (partially shown in Fig. 22). Middle section 208 is a permeable middle section made from a porous material that allows the passage of fluids. Middle section 208 is in fluid communication with internal cavity 210 and allows fluid passage from outside housing 202 into internal cavity 210.

[0089] Proximal end 204 of housing 202 includes an anchor 212 for holding product 100 within the vagina 22. Referring to Fig. 23, product 100 is placed within vagina 22 so that the anchor is superior to fistula 24, and permeable middle section 208 is positioned against fistula 24 (as also shown in Fig. 22). Anchor 212 may be a shoulder having a wider diameter than the remainder of housing 202. In some embodiments, anchor 212 may be inflatable or expandable and is expanded after product 200 is inserted into vagina 22.

[0090] Referring to Figs. 22 and 23, middle section 208 is placed against fistula 24. Fluid from the urethra or rectum passes through middle section 208 into cavity 210 and is collected in distal portion 206 of housing 202. A port 214 is associated with distal portion 206 for draining fluids from housing 202. Port 214 may be connected to a conduit 216 for fluid drainage. Port 214 may have a valve 215. Like the products above, housing 202 can be periodically drained or connected to a collection bag for continuous draining. Furthermore, when anchor 212 is an inflatable device, conduit 216 may include an inflation device 218 in fluid communication with anchor 212 for inflation thereof. The inflation device may or may not be associated with conduit 216.

[0091] Turning to Fig. 23a, product 200a is similar to product 200 in that it has a proximal end 204a, a distal end 206a, and a middle section 208a. It also has a port 214a and drainage conduit 216a. In this embodiment, product 200a, optionally, does not include a superior anchor. Product 200a includes an inferior anchor 220a that holds product 200a within vagina 22. Inferior anchor 220a could be a tension fit ring (similar to a female condom), an expandable sponge (polyvinyl acetal or other material that expands on hydration), or an inflatable balloon anchorage. Product 200a may include an inflation device 218a if an inflatable balloon is used.

[0092] Figs. 24-28 illustrate additional products for treating fistulas. Fig. 24 illustrates product 250, which includes an elastic sleeve 252 with a central passageway therethrough. The elastic sleeve 252 may be a stent-like material or a woven material. Sleeve 252 may be made from a polymer, such as polypropylene. The proximal end 254 and/or distal end (not shown) of sleeve 252 may have an anchoring ring 256 for holding sleeve 252 within the vagina. Anchor ring 256 may have a tension or friction fit with the vaginal wall that holds sleeve 252 within vagina 22. In one embodiment, anchor ring 256 is expandable. For example, anchor ring 256 may be inflatable or made of nitinol.

[0093] Referring to Fig. 25, product 250 may include an applicator 258 that can be used to insert sleeve 252 into the vagina. Sleeve 252 may be in a compact configuration within the applicator 258. Referring to Figs. 24 and 25, the applicator 258 is inserted into vagina 22, and sleeve 252 is deployed. Sleeve 252 expands to the expanded deployed configuration to line the vagina and cover a fistula 24. Anchor ring 256 holds sleeve 252 in place.

[0094] Referring to Fig. 26, to remove sleeve 252, applicator 258 (which may be the same or different applicator) may engage distal end 260 of sleeve 252. The sleeve 252 is then pulled into the applicator 258. As sleeve 252 is pulled into applicator 258, sleeve 252 is forced into a compact configuration and removed from vagina 22. The applicator 258 and sleeve 252 may have features for twisting engagement between the applicator and the sleeve. When inserting or withdrawing the sleeve, application 258 may be twisted to engage the sleeve.

[0095] Referring to Figs. 27 and 28, in an alternative embodiment, product 250 may include an anchor 262 placed in the vagina. As illustrated in Fig. 27, anchor 262 may be placed at a selected location in the vagina. In one embodiment, anchor 262 is placed superior to the location of sleeve 252. In the illustrated figure, deployment device 264 is used to place anchor 262 within vagina 22. Anchor 262 may be a cuff, cap, ring, etc. Anchor 262 may be made from a stiff but pliable material. In one embodiment, anchor 262 could be made of silicone. Referring to Fig. 28, when sleeve 252 is deployed, it engages anchor 262 to hold sleeve 252 in place. This engagement could be any suitable engagement, such as snap-fit, tension fit, threaded, or the like.

[0096] Referring to Fig. 29, any products disclosed herein may include a flushing system to introduce fluids, such as saline or therapeutic solutions (e.g., antimicrobial solutions, tissue repairing solutions, etc.). Saline may be delivered through to the device to irrigate the area. Additionally, therapeutic solutions may be delivered to treat the area. In the illustrated example, a product 300, which may be any of the sleeves, cups, housings, heads, etc. disclosed herein, has one or more lumens 302, 302a with a port 304, 304a that can be connected to a fluid source. Product 300 is shown with two lumens and two ports. It will be understood that the lumens and ports are shown to provide an example, and any of the products could include one or both of these ports and lumens. Port 304 includes a luer fitting with a needless valve, and port 304a includes a check or pinch valve. Of course, other ports and valves may be employed.

[0097] It will also be understood that any of the products disclosed herein could include therapeutic coatings, such as but not limited to antimicrobial silver, antibiotics, virulence triggers, probiotics, disinfectants, hydrogen peroxide or oxygen eluting coating, or polyhexamethylene biguanide, or PHMB). The products may also include desiccants or absorbent hydrogels.

Claims

1. A product for treating vaginal fistulas, comprising: an inflatable member having an outer surface and an inner surface, the inner surface defining an inflation cavity, the inflatable member has an initial inverted configuration and an inflated deployed configuration; a liner for covering fistulas associated with the outer surface of the inflatable member, the liner being releasable from the outer surface; wherein, during inflation, the inflatable member everts, moving from the initial inverted configuration to the deployed inflated configuration within a vagina; and when in the deployed inflated configuration, the inflatable member is configured to deploy the liner over a fistula in a vaginal wall of the vagina.

2. The product of claim 1 , wherein the inflatable member has a deflated configuration for withdrawing the inflatable member from the vagina.

3. The product of any one of claims 1 and 2, further including a deployment device for deploying the inflatable member into the vagina.

4. The product of claim 3, wherein the deployment device comprises a housing having an internal compartment, wherein at least a portion of the inflatable member in the initial inverted configuration is located in the internal compartment of the housing.

5. The produce of claim 4, wherein during inflation, the inflatable member exits from the internal compartment.

6. The product of any one of claims 4 and 5, further including an inflation device operatively connected to the internal compartment, wherein the inflation device delivers a fluid into the internal compartment of the housing and the inflation cavity of the inflatable member.

7. The product of claim 6, wherein the inflation device is a pump or syringe.

8. The product of any one of claims 6 and 7, wherein the fluid is gas or liquid.

9. The product of any one of claims 6-8, further including a pressure sensor for sensing a pressure of the internal compartment of the housing.

10. The product of any one of claims 1 -9, wherein the inflatable member and liner are a disposable assembly that can be separated from the housing and disposed of after use, and the housing is a reusable component.

11. The product of claim 10, further including a plurality of inflatable members configured to be attached to the housing.

12. The product of any one of claims 1 -11 , wherein the liner comprises a strip or material.

13. The product of any one of claims 1 -12, wherein the liner comprises a patch of material.

14. The product of any one of claims 1 -13, wherein the liner comprises a sleeve having a proximal end, a distal end and a passageway therethrough.

15. The product of any one of claims 1 -14, wherein the liner comprises an adhesive.

16. The product of any one of claims 1 -14, wherein the liner is made from a hydrogel.

17. The product of any one of claims 1 -16, wherein the inflatable member is made from a compliant, non-compliant and/or semi-compliant material.

18. A product for treating vaginal fistulas, comprising: a sleeve having a proximal end, a distal end, and a passageway therethrough, the sleeve being sized and configured to be placed in a vagina and against a vaginal wall having a fistula, wherein the sleeve covers the fistula.

19. The product of claim 18, wherein the sleeve comprises an adhesive.

20. The product of claim 18, wherein the sleeve comprises a hydrogel.

21. The product of claim 18, wherein the sleeve comprises a scaffold covered by a film.

22. The product of claim 21 , wherein the scaffold comprises a metal mesh.

23. The product of any one of claims 21 and 22, wherein the film comprises.

24. The product of claim 18, wherein the sleeve comprises a mesh or woven material.

25. The product of claim 24, wherein the sleeve is made from a polymer.

26. The product of any one of claims 18-26, wherein the sleeve has a compact configuration for deployment and an expanded deployed configuration.

27. The product of any one of claims 18-26, further including a delivery device for delivering the sleeve into a vagina.

28. A product for treating vaginal fistulas, comprising: a cup shaped and sized to be placed in a vagina below a fistula, the cup configured to collect fluid leaking from a fistula.

29. The product of claim 28, further comprising a drainage tube for draining the cup.

30. A product for treating vaginal fistulas, comprising: a head shaped and sized to be placed in a vagina below a fistula, the head comprised of an absorbent material that is configured to collect fluid leaking from a fistula.

31. The product of claim 30, further comprising a drainage tube for draining fluid from the head.

32. The product of any one of claims 30 and 31 , wherein the head is a sponge.

33. A product for treating vaginal fistulas, comprising: a vaginal catheter comprising a housing having a wall, wherein at least a portion of the wall is a permeable portion; a vacuum device operatively connected to the housing for creating a vacuum with the housing to pull fluid into the housing.

34. The product of claim 33, wherein the vaginal catheter is sized and shaped to be inserted into the vagina.

35. The product of claim 33, wherein the vaginal catheter is an external catheter.

36. The product of any of claims 1 -33, for including a flushing system for delivering fluids.

37. A product for treating vaginal fistulas, comprising a plug sized and configured to seal the fistula.