The present disclosure relates generally to medical devices, and more specifically, to treatment devices for enteroatmospheric fistulas.
Fistulas are abnormal tissue-lined pathways or communications between two surfaces of the body. For example, fistulas may develop between body cavities and organs, or between cavities or organs and the surface of the body. A fistula pathway or tract includes a void in the soft tissues extending from a primary fistula opening to a blind ending or leading to one or more secondary fistula openings. Fistulas may develop due to a wound, may be the consequence of infection or abscess formation, or may be purposefully developed (e.g., tracheostomy tracts, gastric feeding tube tracts, etc.). However, most abnormal fistulas may typically occur congenitally, after surgery, from surgery related complications, or from trauma. Fistulas may often have tracts or pathways that are epithelialized, endothelialized, or mucosalized.
Fistulas may form between almost any two organs. For example, fistulas may occur between internal organs and the skin (e.g., enterocutaneous fistulas, gastrocutaneous fistulas, anal fistulas, etc.), or between two internal organs (e.g., gastrointestinal fistulas, colovesicular fistulas, etc.). A perforated intestine or bowel exposed through an open abdominal wound is referred to as an “enteroatmospheric fistula.”
Some fistulas may close on their own and may not cause a person significant harm, while some fistulas are life-threatening and may lead to death. For example, an enterocutaneous fistula between the intestinal tract and the skin can cause intestinal content to enter into the abdomen, which can result in significant medical issues. Further, fistulas are often difficult to treat. For example, while negative pressure may often be used to treat other types of abdominal wounds, in the case of enteroatmospheric fistulas, negative pressure may draw enteric succus from the intestinal tract into the abdomen, which can lead to sepsis. Also, it may be difficult to simply suture or stitch an enteric fistula closed. For example, the tissue may be severely damaged, and adding additional perforations to suture the tissue closed may further damage the tissue, preventing healing.
One method of treating a fistula may be surgery in which the fistula and portions of the affected organs are removed. However, this type of surgery is often a major procedure and the mortality rate may be extremely high. Furthermore, patients undergoing this type of surgery, for example, for an enterocutaneous fistula, may have chronic inflammation near the affected area, and may have dense adhesions and highly friable tissues, further complicating the procedure. Other treatment options may include implantable devices designed to aid in the closure of the fistula by the body itself. However, some of these devices may cause an adverse immunological reaction, may allow leakage of fluid from around the device, may become dislodged, or may migrate from their current position as the patient moves.
The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the invention as defined in the claims is to be bound.
One example of the disclosure may include an implantable device for plugging a short-tract opening in tissue, such as a short-tract fistula, and assisting in healing the short-tract opening. The implantable device may include a cap configured to be positioned on a first side of tissue and to substantially cover a first (e.g., proximal) opening of a fistula tract in the tissue. 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 (e.g., distal) opening of the fistula tract. The implantable device may further include a plug structure operably connected between the cap and the anchor member. The plug structure may be configured to be positioned or received within the fistula tract. A short-tract fistula may comprise a region having a relatively constant diameter, as well as a tapered region. Devices described herein may be configured to accommodate this physiology.
Another example of the disclosure may include a method of treating a fistula or wound. The method may include inserting an anchor member into a fistula (e.g., a short-tract fistula) in tissue. The anchor member may then be manipulated (e.g., rotated and/or expanded) so that a first (e.g., distal) opening of the fistula tract is substantially covered by the anchor member. A cap may then be positioned over a second (e.g., proximal) opening of the fistula tract (e.g., after the anchor member is positioned). The cap and the anchor member may then be operably connected to form a seal over at least one of the first and second openings of the fistula tract.
A further example may include an implantable device for treatment of a fistula (e.g., a short-tract fistula in tissue). The device may include a first member configured to be positioned on a first side of a fistula, covering a 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 a second side of the tissue to cover a second opening of the fistula tract. A plug structure may be operably connected to the first and second members and may be configured to be received within the 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 more extensive presentation of features, details, utilities, and advantages of the present invention as defined in the claims is provided in the following written description of various embodiments of the invention and illustrated in the accompanying drawings.
These and other aspects and embodiments will be described in further detail below, in reference to the attached drawing figures.
Embodiments of an implantable device for treating enteroatmospheric fistulas, short-tract fistulas, and other openings in tissue, such as wounds, are described herein. In some embodiments, the implantable device plugs and covers a fistula or wound opening to promote healing (in certain embodiments, without requiring sutures or stitching). The implantable device may be inserted into the fistula or wound opening to close or seal the fistula or wound opening, and may be formed of or include one or more materials that encourage tissue growth in order to help permanently close the fistula or wound opening. The implantable device may be used for a number of different types of fistulas, tissue openings, or other wounds.
The implantable device may include a cap and an anchor member that may be connected together via a plug section or support structure comprising tissue growth enhancing material (e.g., collagen). This configuration may allow tissue to grow into and around the tissue growth enhancing material of the plug section or support structure. Additionally, the cap and the anchor member may be pulled together to seal the tissue opening by either the tissue growth enhancing material plug section or a separate retaining or securing structure (e.g., sutures, bioabsorbable hook and loop, or both). Thus, the implantable device may provide both fistula sealing and a framework for tissue ingrowth.
The first member or cap of the device may be configured to be positioned on a first or exterior surface of the damaged tissue, or against or over a first (e.g., proximal) opening of the short-tract fistula. The cap may, for example, be made of one or more impermeable biocompatible and/or bioabsorbable materials. As such, the cap may be capable of preventing liquids (e.g., enteric succus) and other materials from entering into or exiting out of the fistula opening, while also substantially preventing damage to, and an autoimmune response from, the body as the material may be eventually absorbed by the body. This is important, for example, in the case of an intestinal fistula, where the impermeable cap of the device may prevent intestinal matter and liquids from passing through the fistula into the abdominal cavity. Similarly, the second member or anchor member may be configured to be positioned over a second (e.g., distal) opening of the short-tract fistula (e.g., an opening in an interior surface of the damaged tissue) and may, for example, be made of one or more impermeable biocompatible and bioabsorbable materials. Of course, other appropriate materials may alternatively or additionally be used. The cap and anchor member may be operably connected together, sandwiching the tissue surrounding the fistula therebetween. The cap and the anchor member may be connected together in any appropriate fashion, including but not limited to a plug section, sutures, a keying configuration, hook and loop fasteners, a collagen plug, via magnetic forces, or by other similar structures.
The anchor member may be configured to be inserted into the fistula opening and then expanded and manipulated. This expansion and manipulation may substantially secure the anchor member in place on the second or interior side of the tissue insertion through the opening. In one example, the anchor member may include a series of stacked sheets of uniform or varying diameter that may be folded or compressed while inserted into a first opening of the fistula and then may expand or unfurl when exiting a second opening of the fistula.
In many configurations, the cap and the anchor member may be spaced apart from one another on opposing sides of the tissue surrounding the fistula, but substantially secured in position. This may allow the damaged tissue to grow together within the space between the surfaces of the cap and the anchor, while the fistula is closed or sealed. Additionally, the cap, the anchor member, and/or the separating or securing structure may be bioabsorbable, such that they may eventually be absorbed into the body.
The implantable device 110 is configured to be inserted into the fistula 106 in the tissue 112.
The cap 114 may be formed as a bulbous extension of the plug structure 118 covering one end of the fistula 106. The bulbous cap 114 may be configured to have a larger diameter than a diameter of the opening of the fistula 106, to substantially prevent fluids and other materials from entering or exiting the fistula 106. The cap 114 may be formed of one or more fluid-impermeable materials (e.g., fluid-impermeable silicone), thus preventing fluids and other materials from passing around or through the cap 114 into or out of the fistula 106. In some cases, the cap 114 may be bioabsorbable (e.g., the cap 114 may be formed of one or more bioabsorbable polymers), so that the cap 114 may eventually be absorbed by the body of the person 100. Also, the cap 114 may be other shapes or sizes (see, e.g.,
The cap 114 may be bulbous and may operably extend downward to form the plug structure 118. Referring to
As shown in
Referring now to
Referring to
The sheets 124, 126, 128, 130 may be resilient and flexible, allowing the sheets 124, 126, 128, 130 to be folded or deformed into an insertion position and then to expand or spring outwards upon emerging from the second end of the fistula 106. This may allow the anchor member 116 to be inserted through the fistula 106 without substantially further damaging the tissue 112 or increasing the diameter or size of the fistula 106.
The sheets 124, 126, 128, 130 may be substantially any size or shape, and may be present in any suitable number, as long as they can contract to pass through the fistula 106. For example, in some embodiments, the anchor member 116 may be formed of a single support sheet that may expand outwards on a pull cord similar to an umbrella. Other appropriate anchor member configurations may also be used.
Referring now to
As noted, both the anchor member 116 and the cap 114 may comprise one or more impermeable materials. In this manner, fluids (e.g., enteric succus), waste (e.g., 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. Thus, the implantable device 110 may help to prevent medical complications resulting from the escape of fluids, waste, and the like through the fistula.
Also, as the support structure 118 may comprise one or more tissue growth enhancing materials, such as collagen, the implantable device 110 may provide a tissue growth framework. The tissue 112 may be encouraged to grow within the fistula 106 between the cap 114 and the anchor member 116 throughout the framework of the plug structure 118, to fill the fistula 106 and thereby heal the tissue damage. Furthermore, as the cap 114 and anchor member 116 substantially sandwich or encase the tissue 112, lateral tissue growth may be encouraged across the diameter of the ends of the fistula 106.
The implantable device 110 may include a variety of different embodiments. As an example,
In an exemplary embodiment, and referring to
The securing members 321, 322 function as a hook and loop system in order to secure the cap 314 and the anchor member 316 together, thereby preventing the cap 314 and the anchor member 316 from drifting away from one another. In some embodiments, the hook securing members 321 may be relatively rigid, such that they can pierce the tissue 112 and further act as spacers to space the cap 314 apart from the anchor member 316, to avoid pinching the tissue 112. In certain embodiments, the securing members 318 may be made of one or more bioabsorbable materials so that over time they may eventually be absorbed into the tissue 112.
As shown in
In another embodiment, and referring now to
In this embodiment of the implantable device 410, both the cap 414 and the anchor member 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. Because of the magnetic material(s), the cap 414 and the anchor member 416 may attract each other across the tissue 112 when properly aligned. This magnetic attraction may function similarly to the previously described securing members 320, in that the magnetic force positions the cap 414 substantially above the anchor member 416.
The anchor member 414 may be deformed for insertion into the fistula 106 and then manipulated within the enteric cavity to recover its normal, flat, disk-like shape and cover the opening. As the anchor member 416 may include magnetic elements dispersed through its body, a surgeon may use a magnetic tool to manipulate the anchor member 416 after it has been inserted through the fistula 106. The positioning magnet may align the anchor member 416 so that it substantially covers the fistula 106.
With continuing reference to
The spacer members 418 may have any appropriate configuration, and in some embodiments may be substantially cylindrical shafts or rods that are inserted into the tissue 112 between the cap 414 and the anchor member 416. The spacer members 418 may, for example, comprise one or more bioabsorbable materials (e.g., that are relatively rigid). Non-limiting examples of bioabsorbable materials which may be appropriate include bioabsorbable polymers, such as poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(DL-lactide/glycolide) copolymer (PDLA), and polycaprolactone (PCL). In one embodiment, a spacer member 418 may be formed on and extend from a surface of the cap 414.
In operation, the anchor member 416 may be inserted into the fistula 106 and manipulated within the enteric cavity to cover the hole and adjacent margins of the tissue 112. Once the anchor member 416 is positioned, the spacer members 418 may be inserted into the tissue 112 and operably connected to the anchor member 416. Alternatively or additionally, spacer members 418 may be inserted into the fistula 106, to connect to the anchor member 416 without passing through the tissue 112. The cap 414 may then be placed on top of the first surface of the tissue 112, substantially over the fistula 106 and the anchor member 416. Alternatively, the spacer members 418 may be formed on and extend from a surface of the cap 414. The cap 414 may be placed on the tissue 112 and the spacer members 418 may be pushed through the tissue 112. In some cases, some of the spacer members 418 may be pushed through the tissue 112, while other of the spacer members 418 may be advanced through the fistula 106 without entering the tissue 112. In certain embodiments, all of the spacer members 418 may be advanced through the fistula 106 without entering the tissue 112. The attractive force of the cap 414 and the anchor member 416 may act to hold each of them in place over the first and second ends of the fistula 106.
The cap 514 may have a generally mushroom-shaped top portion that extends downward at a middle portion to form the stem 527. In other embodiments, a stem may not be centrally located on a cap, or multiple stems may be employed. The stem 527 may be similar to the plug structure 118 illustrated in
The anchor member 516 may be shaped substantially the same as the cap 514. As discussed above, the anchor member 516 may define a receiving cavity 525 for receiving the head 529 of the cap 514. Positioning the head 529 within the receiving cavity 525 operably connects the cap 514 to the anchor member 516. The receiving cavity 525 may be substantially the same size as the head 529 and may receive the head 529 in a snap-fit connection, thereby securing the cap 514 to the anchor member 516.
In some embodiments, the cap 514 and the anchor member 516 may include multiple stems and receiving cavities (e.g., for securely connecting a large diameter implantable device 510 to cover and fill a larger diameter fistula). For example,
In operation, the anchor member 516 may be deformed (e.g., folded or rolled) and inserted into the fistula 106. The anchor member 516 may then be manipulated within the enteric cavity so that it is unfolded or unrolled and moved into position. Next, the operator may align the cap 514 with the fistula 106, so that the stem 527 and the head 529 may be inserted into the fistula 106. The head 529 may then be inserted past the second surface 120 of the tissue 112, and received into the receiving cavity 525 so that the head 529 is secured within the cavity 525. In some cases, the anchor member may comprise a pulling member that may be used to hold the anchor member in position while the cap is pushed down. Once the cap 514 and the anchor member 516 are engaged, the tissue 112 may be substantially sandwiched between them. The length of the stem 527 may provide an appropriate setoff distance between the cap 514 and anchor member 516, such that the tissue 112 is not substantially compressed and compromised.
The foregoing description has broad application. For example, while embodiments disclosed herein may focus on closing enteroatmospheric fistulas or other short-tract fistulas, the concepts disclosed herein may equally apply to closing other type 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, the discussion of any embodiment is meant only to be exemplary and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples.
All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. The exemplary drawings are for purposes of illustration only and the dimensions, positions, order and relative sizes reflected in the drawings attached hereto 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 particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of the claimed invention. Other embodiments are therefore contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the invention as defined in the following claims.
The present application claims priority to U.S. Provisional Patent Application No. 61/837,597, entitled “Enteroatmospheric Fistula Treatment Devices and Methods,” filed on Jun. 20, 2013. The full disclosure of the above-listed patent application is hereby incorporated by reference herein.
Number | Date | Country | |
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61837597 | Jun 2013 | US |