CN105407813A - Enteroatmospheric fistula treatment devices - Google Patents

Abstract

An implantable device covers and seals an enteroatmospheric fistula or other short-tract opening in tissue and assists in healing the fistula. The implantable device may include a cap that is configured to be positioned on a first side of the tissue and to substantially cover a first opening of the short-tract fistula. The implantable device may also include an anchor member operably connected to the cap. The anchor member may be configured to be positioned on a second side of the tissue and to substantially cover a second opening of the short-tract fistula. Also, the implantable device may include a plug structure operably connected to the cap and the anchor member. The plug structure may be configured to fill the short-tract fistula.

Description

Bowel air fistula treatment device

Cross References to Related Applications

This application claims priority to US Provisional Patent Application No. 61/837,597, filed June 20, 2013, entitled "Enteroatmospheric Fistula Treatment Devices and Methods." The aforementioned patent applications are hereby incorporated by reference in their entirety.

technical field

The present invention relates generally to medical devices, and more particularly to treatment devices for intestinal air fistulas.

Background technique

A fistula is an abnormal path of tissue connection or means of communication between two surfaces of the body. For example, a fistula may develop between a body cavity and an organ, or between a cavity or organ and a surface of the body. A fistula pathway or lumen comprises a cavity in the soft tissue that extends from a first fistula opening to a closed end or leads to one or more second fistula openings. Fistulas may develop as a result of a wound, may be the result of infection or abscess formation, or may be purposeful (eg, tracheostomy tract, gastric feeding tube, etc.). However, most abnormal fistulas can typically occur congenitally, after surgery, as a result of surgery-related complications, or as a result of trauma. Fistulas may typically have epithelialized, endothelialized, or mucosalized lumens or pathways.

A fistula can form between almost any two organs. For example, a fistula can occur between an internal organ and the skin (eg, enterocutaneous, gastrocutaneous, anal, etc.), or between two internal organs (eg, gastrointestinal, colovesical, etc.). A perforated bowel or rectum exposed through an open abdominal wound is called an "enteric air fistula."

Some fistulas close on their own and may not cause major injury, while some fistulas are life-threatening and may result in death. For example, an enterocutaneous fistula between the intestine and the skin can result in intestinal contents entering the abdomen, which can lead to major medical problems. Additionally, fistulas are often difficult to treat. For example, while negative pressure can often be used to treat other types of abdominal wounds, in the case of intestinal air fistulas, negative pressure may draw intestinal fluid from the intestine into the abdomen, which can lead to sepsis. At the same time, it may be difficult to simply suture or sew closed intestinal fistulas. For example, tissue may be severely damaged, and adding additional perforations to suture closed tissue may further damage tissue, preventing healing.

One method of treating a fistula may be surgery in which the fistula and affected part of the organ are removed. However, such surgical procedures are often major and the mortality rate can be extremely high. Additionally, patients undergoing this type of surgery (for example for enterocutaneous fistulas) may have chronic inflammation near the affected area and may have thick adhesives and highly fragile tissue, further complicating the process. Other treatment options may include implanted devices designed to help the body close the fistula itself. However, some of these devices may cause an adverse immune response, may allow fluid to leak from around the device, may be expelled, or may move from its current location when the patient moves.

The information contained in the Background section of the specification, including any references cited herein and any description or discussion thereon, is included for technical reference purposes only and should not be construed as limiting the scope of the claims. subject matter defining the scope of the invention.

Contents of the invention

An example of the invention may include an implantable device for occluding a short opening in tissue, such as a short fistula, and facilitating healing of the short opening. The implantable device can include a cap configured to be positioned on the first side of the tissue and substantially cover a first (eg, proximal) opening of the fistula tract in the tissue. The implantable device may also include an anchor operably connected to the cap. The anchor can be configured to be positioned on the second side of the tissue and substantially cover the second (eg, distal) opening of the fistula tract. The implantable device may also include a plug structure operatively connected between the cap and the anchor. The plug structure may be configured to be positioned or received in a fistula tract. A short-track fistula may include a region of relatively constant diameter and a tapered region. The devices described herein can be configured to accommodate this anatomy.

Another example of the invention may include a method of treating a fistula or wound. The method can include inserting the anchor into a fistula (eg, a short fistula) in tissue. The anchor can then be manipulated (eg, rotated and/or expanded) such that the anchor substantially covers the first (eg, distal) opening of the fistula tract. The cap can then be positioned over the second (eg, proximal) opening of the fistula tract (eg, after the anchor is in place). The cap and anchor can then be operatively connected to form a seal over at least one of the first and second openings of the fistula tract.

Another example may include an implantable device for treating fistulas, such as short tract fistulas in tissue. The device may include a first member configured to be positioned on a first side of the fistula tract, covering the first opening of the fistula tract. The device may also include a second member configured to be operably connected to the first member and positioned on the second side of the tissue to cover the second opening of the fistula tract. The plug structure can be operably connected to the first and second members, and can be configured to be received in a fistula.

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. A greater description of the features, details, utilities and advantages of the invention as defined in the claims is provided in the following written description of various embodiments of the invention and shown in the accompanying drawings.

These and other aspects and embodiments will be described in more detail below with reference to the accompanying drawings.

Description of drawings

Figure 1A is a front view of a human with an intestinal air fistula (ie, a perforated intestine accessible through a wound opening in the epidermis).

Figure IB is an enlarged cross-sectional view of a fistula in the intestine.

2 is an isometric view of the implantable device in an extended position configured to be inserted into the intestinal fistula of FIG. 1B.

3A is a cross-sectional view of the implantable device of FIG. 2 partially inserted in an intestinal fistula.

3B is a cross-sectional view of the implantable device of FIG. 2 inserted through an intestinal fistula.

3C is a cross-sectional view of the implantable device of FIG. 2 partially occluding an intestinal fistula.

3D is a cross-sectional view of the implantable device of FIG. 2 fully inserted and occluding an intestinal fistula.

3E is a top plan view of the implantable device of FIG. 2 inserted in an intestinal fistula.

4A is a cross-sectional view of the implantable device of FIG. 2 inserted in a fistula opening with the anchor in an inserted configuration.

4B is a cross-sectional view of the implantable device of FIG. 2 inserted in a fistula opening with the anchor in an expanded configuration.

5 is an isometric view of another example of the implantable device of FIG. 2 in a collapsed or inserted configuration.

6A is a cross-sectional view of the implantable device of FIG. 5 in position over a fistula opening prior to insertion.

6B is a cross-sectional view of the implantable device of FIG. 5 inserted in a fistula with the anchor in the inserted configuration.

6C is a cross-sectional view of the implantable device of FIG. 5 inserted in a fistula with the anchor in an expanded configuration.

7 is an isometric view of another embodiment of an implantable intestinal air fistula treatment device.

8A is a cross-sectional view of the implantable device of FIG. 7 inserted in a fistula.

8B is an enlarged cross-sectional view of FIG. 8A showing a fixation member of the implantable device.

8C is a top plan view of the implantable device of FIG. 7 inserted in a fistula.

Figure 9 is an isometric view of another embodiment of an implantable intestinal air fistula treatment device.

10A is a cross-sectional view of the implantable device of FIG. 9 inserted in a fistula.

10B is a top plan view of the implantable device of FIG. 9 inserted in a fistula.

11A is an isometric view of another embodiment of an implantable intestinal air fistula treatment device.

11B is an exploded front cross-sectional view of the implantable device of FIG. 11A.

12A is a cross-sectional view of the implantable device of FIG. 11A inserted in a fistula.

12B is a top plan view of the implantable device of FIG. 11A inserted in a fistula.

13 is an exploded view of another example of the implantable device of FIG. 11A.

detailed description

Described herein are embodiments of implantable devices for treating intestinal air fistulas, short tract fistulas, and other openings in tissue, such as wounds. In some embodiments, the implantable device occludes and covers the fistula or wound opening to promote healing (in some embodiments, sutures or stitches are not required). The implantable device can be inserted into a fistula or wound opening to close or seal the fistula or wound opening and can be made of or include one or more tissue growth promoting materials to help permanently close the fistula or wound openings. Implantable devices can be used in a number of different types of fistulas, tissue openings or other wounds.

The implantable device may include a cap and an anchor, which may be connected together via a plug segment or support structure comprising a tissue growth promoting material such as collagen. This configuration may allow tissue growth into and around the tissue growth promoting material of the plug section or support structure. Additionally, the cap and anchor may be pulled together to plug the segment through tissue growth promoting material or through a separate retaining or fastening structure (such as sutures, bioabsorbable hooks and loops, or both) to seal tissue openings. Thus, the implantable device can provide a fistula seal and framework for tissue ingrowth.

The first member or cap of the device may be configured to be positioned on the first or outer surface of the damaged tissue, or against or above the first (eg, proximal) opening of the short-track fistula. For example, the cap can be made of one or more impermeable biocompatible and/or bioabsorbable materials. In this way, the cap may be able to prevent liquids (eg, intestinal fluid) and other materials from entering or exiting the fistula opening while also substantially preventing damage to the body and autoimmune responses from the body as the material may eventually be absorbed by the body. This is very important, for example, in the case of intestinal fistulas, where the impermeable cap of the device prevents intestinal material and fluids from passing through the fistula into the abdominal cavity. Similarly, the second member or anchor can be configured to be positioned over a second (e.g., distal) opening of the short-track fistula (e.g., an opening in the interior surface of damaged tissue), and can be formed, for example, by one or more incapable components. Permeable biocompatible and bioabsorbable material. Of course, other suitable materials may alternatively or additionally be used. The cap and anchor can be operatively connected together, sandwiching tissue surrounding the fistula. The cap and anchor can be joined together by any suitable means, including, but not limited to, plug segments, sutures, keyed formations, hook and loop fasteners, collagen plugs, via magnetic force, or by other means. similar structure.

The anchor can be configured to be inserted into the fistula opening, then expanded and manipulated. This expansion and manipulation may substantially secure the anchor in place on the second or medial side of the tissue insert passing through the opening. In one example, the anchor may comprise a series of stacked sheets of the same or varying diameters that may be folded or compressed when inserted into a first opening of the fistula tract and then exited at a second opening of the fistula tract. Can be expanded or unfolded when open.

In various configurations, the cap and anchor may be spaced apart from each other on opposite sides of the tissue surrounding the fistula, but substantially secured in place. This may allow damaged tissue to grow together in the space between the cap and the surface of the anchor while closing or sealing the fistula. Additionally, the cap, anchor and/or separating or fastening structure may be bioabsorbable such that it can eventually be absorbed into the body.

FIG. 1A is a front view of a person 100 with a perforated intestine 105 . An open wound 102 in the abdominal wall 104 exposes a fistula 106 in the bowel 105 to the atmosphere. Due to the additional wound 102 in the abdominal cavity 104, the fistula 106 may be difficult to treat. FIG. 1B is an enlarged view of damaged intestinal tissue 112 showing fistula 106 . Fistula 106 may extend through one or more layers of tissue 112 and may have any of a number of different sizes and shapes.

FIG. 2 is an isometric view of the implantable device 110 for closing the entire fistula tract 106 . Implantable device 110 extends to cover the margins of tissue 112 on both sides of fistula tract 106 and occludes the fistula tract, thereby providing a framework for tissue 112 to grow to permanently close fistula tract 106 . Although the implantable device 110 is illustrated as closing a fistula 106 in the intestinal tract 105, it can be used to close essentially any short length opening in tissue, including but not limited to short fistulas, colon tears, vascular perforations Wait.

Implantable device 110 is configured to be inserted into fistula 106 in tissue 112 . 3A-3D are cross-sectional views of the implantable device of FIG. 2 partially inserted in an intestinal fistula, inserted through an intestinal fistula, partially occluded an intestinal fistula, and fully inserted and occluded an intestinal fistula, respectively. 3E is a top plan view of the implantable device of FIG. 2 inserted in an intestinal fistula. As shown, the implantable device 110 can include a cap 114 , an anchor 116 operably connected or coupled to the cap 114 , and a plug structure 118 . Cap 114 may have a smaller diameter than anchor 116 when anchor 116 is in its expanded position (see, eg, FIG. 2 ). Cap 114 is configured to be inserted over first (eg, proximal) surface 122 ( FIG. 3D ) of tissue 112 , and over and partially into opening 106 .

Cap 114 may be formed as a spherical extension of plug structure 118 covering one end of fistula tract 106 . Spherical cap 114 may be configured to have a diameter larger than the diameter of the opening of fistula tract 106 to substantially prevent fluids and other materials from entering or exiting fistula tract 106 . Cap 114 may be formed from one or more fluid-impermeable materials, such as fluid-impermeable silicone, thereby preventing fluid and other materials from entering or exiting fistula 106 around or through cap 114 . In some cases, cap 114 may be bioabsorbable (eg, cap 114 may be formed from one or more bioabsorbable polymers) such that cap 114 may eventually be absorbed by the body of person 100 . Cap 114 may also be of other shapes or sizes (see, eg, FIG. 6A ).

The cap portion 114 may be spherical and may be operable to extend downwardly to form a plug structure 118 . Referring to FIGS. 2 and 3D , the plug structure 118 may be a shaft extending downwardly (or distally) from the bottom surface of the cap 114 and operatively connected to the anchor 116 . The plug structure 118 operably connects the cap 114 to the anchor 116 and keeps the two spaced apart from each other. This may advantageously prevent cap 114 and anchor 116 from pinching or otherwise forcing tissue 112 away from its intervening position. Plug structure 118 may be made of a tissue growth promoting material such as collagen. Thus, the plug structure 118 can provide a type of framework or scaffold through which tissue can grow to fill the fistula 106 . Other suitable materials may alternatively or additionally be used.

As shown in FIG. 3A, anchor 116 may be substantially flexible such that it may be inserted into a fistula and then expanded outward (as shown in FIG. 3D). Referring to Figure 3B, in one embodiment, implantable device 110 may be inserted through the fistula tract, starting with anchor 116, until the entire device 110 is positioned on the opposite side of the tissue. After the implantable device 110 is inserted, the surgeon may pull on the drawstring 113 operably connected to the cap 114 . Referring now to FIG. 3C , with the cap 114 being forced upward, the cap 114 and plug structure 118 can be reinserted into the fistula. The anchor 116 is not reinserted, but forms a seal over the bottom opening of the fistula. Referring now to FIG. 3D , once the cap 114 has reached the other opening of the fistula tract, it can expand to form a plug or seal on the opposite side of the fistula tract. FIG. 3E is a top plan view of implantable device 110 inserted in fistula tract 106 .

Referring now to FIGS. 4A and 4B, the anchor 116 may comprise a series of successively smaller sized sheets 124, 126, 128, 130 which may be compressed or deformed to fit through the fistula tract and then may be expanded or resized. Reshape (e.g. into original sheet shape). The sheets 124 , 126 , 128 , 130 may be shrunk or folded prior to insertion of the implantable device 110 into the fistula tract 106 . After the sheets 124, 126, 128, 130 pass through the fistula and into the abdominal cavity, the plug structure 118 is seated in the fistula 106, and the sheets 124, 126, 128, 130 may expand outward. As such, the sheets 124 , 126 , 128 , 130 of the anchor 116 may cover the second end of the fistula 106 and may be wider than the opening 106 but may still be insertable into the opening 106 . Anchor 116 covers the opening of fistula tract 106 on the inner wall of tissue 112 and serves to anchor implantable device 110 within fistula tract 106 preventing implantable device 110 from being easily dislodged or forced out of fistula tract 106 . The sheets 124, 126, 128, 130 may comprise any suitable material or materials (eg, collagen) and may comprise the same or different materials.

4A is a cross-section of implantable device 110 inserted in fistula tract 106 before anchor 116 is expanded, and FIG. 4B is a cross-sectional view of implantable device 110 inserted in fistula 106 after anchor 116 is expanded. Sheets 124 , 126 , 128 , 130 may be deformed to be bent or folded or bent around each other in order to be inserted into fistula tract 106 . For example, the small diameter inner sheet 130 may be bent or folded downward from its central connection point with the adjacent sheet 128 . A middle sheet 128 having a larger diameter than the inner sheet 130 may be folded adjacent to the inner sheet 130 and substantially over and around the inner sheet 130, a second middle sheet 128 having a larger diameter than the first middle sheet 128. Intermediate sheet 126 may similarly deform around first intermediate sheet 128 . The outer sheet 124 having the larger diameter may be folded over the middle sheet 126 and thus over the middle and inner sheets 128 , 130 . In some embodiments, the sheets 124 , 126 , 128 , 130 may be joined at midpoints of each sheet 124 , 126 , 128 , 130 .

Referring to Figure 4B, after the sheets 124, 126, 128, 130 are inserted through the fistula 106 and into the abdominal cavity, the sheets 124, 126, 128, 130 may expand outwardly. Outer sheet 124 can be positioned adjacent to second surface 120 of tissue 112, second intermediate sheet 126 can be positioned adjacent to outer sheet 124, and first intermediate sheet 128 can be positioned adjacent to second surface 120. Adjacent the middle sheet 126 , the inner sheet 130 may be positioned adjacent to the first middle sheet 128 . In this configuration, the sheets 124, 126, 128, 130 form a stepped inverted pyramid or frusto-conical structure. Outer sheet 124 is configured to expand over the inner opening in tissue 112 to form a cover or seal over fistula 106 . Intermediate sheets 126 , 128 and inner sheet 130 provide a self-supporting structure to ensure that the span of largest diameter sheet 124 covers and seals the opening of fistula tract 106 . Each sheet 124 , 126 , 128 , 130 may be made from a slightly different material formulation to increase stiffness from the largest diameter sheet 124 to the smallest diameter sheet 130 . In this way, the smallest sheet may be better able to support the span of the largest sheet 124 . Alternatively, based on the material forming the sheets 124, 126, 128, 130, the inherent structure of the material may increase relative stiffness as size decreases.

The sheets 124, 126, 128, 130 may be resilient and flexible, allowing the sheets 124, 126, 128, 130 to fold or deform into the insertion position, and then expand outward when emerging from the second end of the fistula tract 106. or pop open. This may allow anchor 116 to be inserted through fistula 106 without substantially further damaging tissue 112 or increasing the diameter or size of fistula 106 .

Sheets 124 , 126 , 128 , 130 may be of substantially any size or shape, and may be present in any suitable number, so long as they are capable of collapsing to pass through fistula tract 106 . For example, in some embodiments, anchor 116 may be formed from a single support sheet, similar to an umbrella, that may expand outward on a drawstring. Other suitable anchor configurations may also be used.

Referring now to FIGS. 3A and 4B , when implantable device 110 is seated in fistula tract 106 and anchor 116 is expanded, implantable device 110 may substantially cover fistula tract 106 on both surfaces of tissue 112 . Cap 114 is configured to seat over a first (eg, proximal) opening of fistula tract 106 in first surface 122 of tissue 112 . Plug structure 118 is inserted into fistula tract 106 and may be configured to have approximately the same diameter as fistula tract 106 , thereby filling fistula tract 106 . When expanded, anchor 116 covers the second (eg, distal) opening of fistula tract 106 and is positioned adjacent to second surface 120 of tissue 112 . Cap 114 and anchor 116 may be spaced apart from each other by a distance at least equal to the thickness of tissue 112 . For example, as shown in FIG. 3A , the plug structure 118 can have a length that is about the same as the thickness of the tissue 112 , and thus can provide an appropriate separation distance between the cap 114 and the anchor 116 .

It should be noted that anchor 116 and cap 114 may comprise one or more impermeable materials. In this manner, fluid (eg, intestinal fluid), waste (eg, feces), and other materials may be substantially prevented from traveling from the second surface 120 of the tissue 112 to the first surface 122 of the tissue 112 via the fistula 106 . Accordingly, implantable device 110 may help prevent medical complications due to leakage of fluid, waste, etc. through the fistula.

Also, since support structure 118 may include one or more tissue growth promoting materials, such as collagen, implantable device 110 may provide a framework for tissue growth. Growth of tissue 112 in fistula 106 between cap 114 and anchor 116 through the framework of plug structure 118 may be promoted to fill fistula 106 and thereby heal tissue damage. Additionally, since the cap 114 and anchor 116 substantially clamp or encase the tissue 112, transverse tissue growth across the diameter of the end of the fistula tract 106 may be promoted.

Implantable device 110 may comprise a variety of different embodiments. For example, FIG. 5 is an isometric view of another configuration of implantable device 210 , which may be substantially similar to implantable device 110 shown in FIG. 2 . However, implantable device 210 may include a differently shaped cap 214 . In this embodiment, cap 214 is substantially planar or disk-shaped rather than spherical. Other embodiments of implantable devices may include caps having other different shapes.

FIG. 6A shows implantable device 210 before insertion into fistula tract 106 , FIG. 6B shows implantable device 210 during insertion into fistula tract 106 , and FIG. 6C shows implantable device 210 after insertion into fistula tract 106 . As shown in Figure 6A, prior to insertion, the sheets 124, 126, 128, 130 may be deformed to pass through the fistula 106, as explained above with respect to Figure 4A. As can be seen, the sheets 124, 126, 128, 130 can be folded down to flex around each other. As shown in FIG. 6B , when the plug structure 118 is inserted into the fistula tract 106 , the sheets 124 , 126 , 128 may begin to expand as they reach the second side of the fistula tract 106 . Referring now to FIG. 6C , once the plug structure 118 is fully inserted into the fistula tract 106 , the sheets 124 , 126 , 128 , 130 may be fully expanded to form the anchor 116 . The anchor 116 covers the second end of the fistula tract 106 .

FIG. 7 is an isometric view of another embodiment of an implantable device 310 . Implantable device 310 may be substantially similar to implantable device 110 in that it may include cap 314 and anchor 316 . However, implantable device 310 may not include a plug structure. Instead, anchor 316 and cap 314 may be operatively connected via fastener 318 . Additionally, the anchor 316 may be a single piece rather than being formed from multiple sheets as in previous embodiments. Of course, other suitable configurations of anchors may also be used with the anchor.

8A is a cross-sectional view of implantable device 310 inserted in fistula tract 106 , FIG. 8B is an enlarged view of a portion of FIG. 8A , and FIG. 8C is a top plan view of implantable device 310 inserted in fistula tract 106 . Anchor 316 may be a generally disc-shaped member having a larger diameter than the opening of fistula tract 106 . In some embodiments, anchor 316 may be deformed and inserted through fistula 106 , wherein the anchor may be manipulated by a surgeon once the anchor has been deployed in the recess adjacent second side 120 of tissue 112 . For example, the anchor 316 can be manipulated for placement adjacent the second side 120 of the tissue 112 and can be positioned to substantially cover the opening of the fistula 106 . In such an embodiment, anchor 316 may be substantially similar to cap 314 and may be formed of an impermeable material to seal fistula 106 .

Figure 8B is an enlarged view of implantable device 310 inserted into fistula tract 106 as shown in Figure 8A. Once anchor 316 has been positioned to cover the opening of fistula tract 106, cap 314 and anchor 316 may be secured together. A fastener 318 may be operably connected to each cap 314 and anchor 316 . In certain embodiments, the fixation 318 connected to the cap 314 may also be connected to an opposing fixation 318 which in turn is connected to the anchor 316 . In some embodiments, the anchor 318 may be inserted into the tissue 112 surrounding the fistula 106 .

In an exemplary embodiment, referring to FIG. 8B , at least some of the fasteners 318 may include hook fasteners 321 and loop fasteners 322 . The hook fastener 321 may be configured to engage or connect with the loop fastener 322 . In an example, the bottom surface of cap 314 may be formed with hook fasteners 321 and the top surface of anchor 316 may be formed with loop fasteners 322 . Hook fastener 321 may be pressed through tissue 112 and out into a cavity on the opposite side of fistula 106 to engage loop fastener 322 . Other embodiments and combinations of fasteners may also be used.

The fasteners 321, 322 act as a hook and loop system to secure the cap 314 and anchor 316 together, thereby preventing the cap 314 and anchor 316 from drifting away from each other. In some embodiments, the hook fixture 321 can be relatively rigid so that it can penetrate the tissue 112 and also act as a spacer separating the cap 314 from the anchor 316 to avoid pinching the tissue 112 . In some embodiments, the fixation member 318 can be made from one or more bioabsorbable materials so that it can eventually be absorbed into the tissue 112 over time.

As shown in FIG. 8A , when inserted, implantable device 310 clamps tissue 112 between cap 314 and anchor 316 . Collagen plug 317 may be disposed in fistula 106 between cap 314 and anchor 316 to promote tissue growth in fistula 106 . This configuration can help ensure more rapid healing of ruptured tissue 112 . In addition, cap 314 may be positioned to cover fistula 106 to help prevent fluids and other materials from entering or exiting fistula 106 .

In another embodiment, referring now to FIG. 9 , implantable device 410 may use an attractive force (eg, magnetic force) to secure cap 414 and anchor 416 in place. FIG. 10A is a cross-sectional view of implantable device 410 inserted in fistula tract 106 , and FIG. 10B is a top plan view of implantable device 410 . In this embodiment, cap 414 and anchor 416 may have substantially the same dimensions.

In this embodiment of implantable device 410, both cap 414 and anchor 416 may include one or more types of magnetic materials, such as ferromagnetic materials, dispersed throughout their bodies. Non-limiting examples of ferromagnetic materials include iron, iron oxides, magnetite, and ferrofluids. Due to the magnetic material, cap 414 and anchor 416 may attract each other across tissue 112 when properly aligned. This magnetic attraction may function similarly to the previously described mount 320 in that the magnetic force holds the cap 414 substantially in place over the anchor 416 .

The anchor 414 can be deformed for insertion into the fistula 106 and then manipulated in the abdominal cavity to restore its normal planar disc shape and cover the opening. Since the anchor 416 may include magnetic elements dispersed throughout its body, the surgeon may use magnetic tools to manipulate the anchor 416 after the anchor 416 has been inserted through the fistula 106 . Positioning the magnets can align the anchor 416 such that it substantially covers the fistula 106 .

With continued reference to FIGS. 9 and 10A , implantable device 410 may additionally include a spacer 418 positioned between cap 414 and anchor 416 . Spacer 418 may help prevent a direct connection between cap 414 and anchor 416 that could pinch tissue 112 or force tissue 112 away from between cap 414 and anchor 416 . In some cases, if the magnetic attraction between cap 414 and anchor 416 causes these two components to compress and necrose tissue 112 around the edge of fistula 106 over time, thereby enlarging fistula 106 and Instead of promoting healing, spacer 418 may be used. In some embodiments, spacer 418 may have a height substantially equal to the thickness of tissue 112 . This may allow cap 414 and anchor 416 to be spaced far enough apart to avoid putting too much pressure on tissue 112 , yet close enough together to provide a good seal against tissue 112 .

Spacer 418 may have any suitable configuration and, in some embodiments, may be a substantially cylindrical shaft or rod inserted into tissue 112 between cap 414 and anchor 416 . For example, spacer 418 may comprise one or more bioabsorbable materials (eg, relatively rigid materials). Non-limiting examples of potentially suitable bioabsorbable materials include bioabsorbable polymers such as poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(dex-lactide/co-glycolide) (PDLA) and polycaprolactone (PCL). In one embodiment, spacer 418 may be formed on and extend from a surface of cap 414 .

In operation, anchor 416 may be inserted into fistula tract 106 and manipulated in the abdominal cavity to cover the rim of the hole and adjacent tissue 112 . Once anchor 416 is in place, spacer 418 may be inserted into tissue 112 and operably connected to anchor 416 . Alternatively or additionally, spacer 418 may be inserted into fistula 106 to connect to anchor 416 without passing through tissue 112 . Cap 414 may then be disposed on top of the first surface of tissue 112 , substantially over fistula tract 106 and anchor 416 . Optionally, spacer 418 may be formed on and extend from a surface of cap 414 . Cap 414 may be disposed over tissue 112 and septum 418 may be advanced through tissue 112 . In some cases, some spacers 418 may be advanced through tissue 112 while other spacers 418 may be advanced through fistula tract 106 without entering tissue 112 . In certain embodiments, the entirety of septum 418 may be advanced through fistula tract 106 without entering tissue 112 . The attractive force of cap 414 and anchor 416 may serve to hold each in place over the first and second ends of fistula 106 .

11A and 11B are exploded isometric and frontal views, respectively, of another embodiment of an implantable device 510 . In this embodiment, the implantable device 510 can include a cap 514 having a shaft 527 with a head 529 at a first end. Implantable device 510 may also include an anchor 516 defining a receiving cavity 525 configured to receive a head 529 of cap 514 . 12A is a cross-sectional view of implantable device 510 inserted in fistula tract 106 , and FIG. 12B is a top plan view of implantable device 510 inserted in fistula tract 106 . Cap 514 and anchor 516 are configured to be fastened together in a snap fit or other suitable fastening configuration.

Cap 514 may have a generally mushroom-shaped top portion that extends downward at a middle portion to form shank 527 . In other embodiments, the stem may not be centrally located on the cap, or multiple stems may be used. Stem 527 may be similar to plug structure 118 shown in FIG. 2A in that stem 527 is configured to be inserted into fistula tract 106 . A first end of the shaft 527 inserted into the fistula 106 may extend outwardly to form a spherical head 529 . Stem 527 and head 529 may each be formed from a tissue growth promoting substance such as collagen. This may allow tissue 112 to grow around and through shaft 527 and head 529 to fill fistula 106 .

The anchor 516 may be shaped substantially the same as the cap 514 . As noted above, the anchor 516 can define a receiving cavity 525 for receiving the head 529 of the cap 514 . Positioning the head portion 529 in the receiving cavity 525 operatively connects the cap portion 514 to the anchor 516 . Receiving cavity 525 may be substantially the same size as head 529 and may receive head 529 in a snap-fit connection to secure cap 514 to anchor 516 .

In some embodiments, cap 514 and anchor 516 may include multiple stems and receiving cavities (e.g., for securely attaching a large diameter implantable device 510 to cover and fill larger diameter fistulas) . For example, FIG. 13 shows a cap 514 having three shanks 527 extending from the bottom surface and an anchor 516 including three receiving cavities 525 for receiving heads 529 . Also, while a circular head and cavity configuration is shown, other forms of keying structures are possible, and the snap-fit connection shown in FIGS. 11A and 13 is only one exemplary embodiment.

In operation, anchor 516 may be deformed (eg, folded or rolled) and inserted into fistula 106 . The anchor 516 can then be manipulated in the abdominal cavity to deploy or spread and move into position. The operator can then align cap 514 with fistula 106 so that shaft 527 and head 529 can be inserted into fistula 106 . The head 529 may then be inserted through the second surface 120 of the tissue 112 and received in the receiving cavity 525 such that the head 529 is secured in the cavity 525 . In some cases, the anchor can include a puller that can be used to hold the anchor in place when the cap is pushed down. Once the cap 514 and the anchor are engaged, the tissue 112 can be substantially sandwiched between them. The length of the shaft 527 can provide a suitable offset distance between the cap 514 and the anchor 516 so that the tissue 112 is not substantially compressed and retreated.

The above description has broad application. For example, while the embodiments disclosed herein may focus on closing intestinal air fistulas or other short tract fistulas, the concepts disclosed herein may equally apply to closing other types of wounds and tissue openings. Similarly, although fistulas and wounds may be discussed with respect to humans, the devices and techniques disclosed herein are equally applicable to other animals. Accordingly, discussion of any embodiments is intended to be exemplary only, and is not intended to suggest that the scope of the invention, including the claims, be limited by these examples.

All directional terms (e.g., proximal, distal, upper, lower, up, down, left, right, transverse, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial , axial, clockwise, and counterclockwise) are for identification purposes only to aid the reader in understanding the application and are not intended to be limiting, particularly with respect to position, orientation, or use of the invention. Connective terms such as attached, coupled, connected, and joined are to be interpreted broadly and, unless otherwise indicated, may include intermediate members between a number of elements and relative movement between those elements. As such, joinder terms do not necessarily mean that two elements are directly connected and in fixed relation to each other. The exemplary drawings are for illustration purposes only, and the size, position, order and relative dimensions reflected in the drawings may vary.

The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the invention as defined in the claims. Although various embodiments of the claimed invention have been described above with a certain degree of specificity or with reference to one or more individual embodiments, without departing from the spirit or scope of the invention as claimed, the art Various changes to the disclosed embodiments can be made by those skilled in the art. Other embodiments are therefore conceivable. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative of particular embodiments only and not in limitation. Changes in detail or structure may be made without departing from the essential elements of the invention as defined in the claims below.

Claims (16)

1. An implantable device configured for insertion into a short-track fistula in tissue, the implantable device comprising: a cap configured to be positioned on the first side of the tissue and substantially cover the first opening of the short tract fistula; an anchor operatively connected to the cap and configured to be positioned on the second side of the tissue and substantially covering the second opening of the short tract fistula; and A plug structure is operably connected between the cap and the anchor and is configured to be positioned in the short tract fistula. 2. The implantable device of claim 1, wherein the first opening is a proximal opening of a short-track fistula. 3. The implantable device of claim 2, wherein the second opening is a distal opening of a short-track fistula. 4. The implantable device of claim 1, wherein the plug structure comprises collagen. 5. The implantable device of claim 1, further comprising: a hook fastener operably connected to the surface of the cap; and a loop fastener operably connected to the surface of the anchor, Therein, the hook fastener is configured to pass through tissue and to be inserted into the loop fastener. 6. The implantable device of claim 1, wherein: The cap also includes a first magnetic material; and The anchor includes a second magnetic material that is substantially attracted to the first magnetic material. 7. The implantable device of claim 1, wherein the anchor comprises a first sheet having a first configuration to allow passage through a short tract fistula and a second expanded configuration having a size type, the second expanded configuration has a dimension larger than the diameter of the short-track fistula. 8. The implantable device of claim 7, wherein the anchor further comprises a second sheet operatively connected to the first sheet and having a third configuration and a dimension The expanded fourth configuration has a size larger than the diameter of the short tract fistula but smaller than the size of the first sheet. 9. The implantable device of claim 1, wherein the plug structure is connected directly to the cap and to the anchor via a snap-fit connection. 10. The implantable device of claim 9, wherein the plug structure further comprises: a shank extending from the bottom surface of the cap; and A head extending from the bottom end of the shank. 11. The implantable device of claim 10, wherein the anchor further comprises a cavity configured to receive at least a portion of the head. 12. An implantable device comprising: a first member configured to be positioned on the first side of the tissue to cover the first opening of the short tract fistula in the tissue; a second member configured to be operably connected to the first member and to be positioned on the second side of the tissue to cover the second opening of the short tract fistula; and A plug structure is operably connected to the first member and the second member and is configured to be received in a short-track fistula. 13. The implantable device of claim 12, wherein the second member is configured to deform into the first configuration prior to insertion into the short tract fistula, and to expand into the second configuration after insertion into the short tract fistula. 14. The implantable device of claim 13, wherein the second member comprises a first sheet configured to be deformed into a first configuration and expanded into a second configuration to have A size larger than the diameter of a short-track fistula. 15. The implantable device of claim 12, wherein the plug structure is directly connected to the first member and is connected to the second member via a snap-fit connection. 16. The implantable device of claim 12, wherein the plug structure is a tissue growth framework material.