Patent Grant
9211116
The present invention relates to medical apparatus and methods. More specifically, the present invention relates to implantable devices for closing fistulas and methods of using such devices.
Fistulas are a major cause of morbidity and mortality, as there are over one hundred thousand cases of pathologic fistulas a year, which account for over ten thousand deaths. They cost the healthcare system billions of dollars each year to treat.
Fistulas are tissue-lined connections between body cavities and hollow organs or between such cavities or organs and the surface of the body. The fistula tract includes a void or potential void in the soft tissues extending from a primary fistula opening to a blind ending or leading to one or more secondary fistula openings, sometimes following along tissue planes of organs or between organs. Fistulas frequently develop as a consequence of infections or accompany abscess formations. Although some fistulas are purposely created for therapeutic purposes such as tracheostomy tracts, gastric feeding tube tracts, or arteriovenous fistulas for dialysis access, pathological fistulas are abnormal tracts that typically occur either congenitally or form after surgery, surgery-related complications, or trauma. They are most often open tracts that have epithelialized, endothelialized, or mucosalized.
Fistulas can form between almost any two-organ systems, or multiple organs between different sites of the same organ. For example, they may occur between internal organs and skin (enterocutaneous fistulas, gastrocutaneous fistulas, anal fistulas, rectovaginal fistulas, colocutaneous fistulas, vesiclocutaneous fistulas, intestinocutaneous fistulas, tracheocutaneous fistulas, bronchocutaneous fistulas, etc.) or between internal organs themselves (tracheal-esophageal fistulas, gastrointestinal fistulas, colovesicular fistulas, palatal fistulas, etc.). Fistulas may also form between blood vessels such as arteriovenous fistulas.
Although fistulas may form in many locations in the body, they are almost universally highly morbid to patients and difficult for clinicians to treat. For example, enterocutaneous fistulas are one of the most feared complications of abdominal surgery. Enterocutaneous fistulas are abnormal connections that form between the bowel and skin and can occur after abdominal surgery, after trauma, or as a complication of Crohn's disease. Some reports estimate that enterocutaneous fistulas may form in as many as 1% of patients that undergo major abdominal surgery. They often require months of supportive care and/or major abdominal surgery. The overall mortality rate for patients that develop enterocutaneous fistulas remains high at around 20%.
Current options for treatment of enterocutaneous fistulas include long-term conservative management or major surgery. In a first option, the patients are placed on restricted enteric intake and managed with parenteral nutritional support. The fistula leakage is controlled using a stoma bag. If the fistula output is high, drains are sometimes placed to try and control the fistula output. Spontaneous closure is relatively low at around 25%. If fistulas fail to spontaneously close with current management after 5 weeks of bowel rest, then many surgeons advocate surgical treatment at this point, though supportive care could continue indefinitely. Patients with open fistula tracts often have ongoing associated malnutrition and electrolyte imbalance issues as well as chronic non-healing abdominal wounds.
A second option is a major surgery, which has a mortality rate near 30%. The surgery involves resection of the diseased intestinal segment, extirpation of the fistula, and debridement of the fistulous tract through the abdominal wall and subcutaneous tissue. This major abdominal surgery often requires blood transfusion and post-operative ICU admissions. As a result of chronic inflammation and having abdomens that have been previously operated on, these patients typically form dense adhesions and have highly friable tissues. In addition, these patients can be severely malnourished. These conditions make operations on enterocutaneous fistulas extremely difficult and dangerous. After the surgery the patient is put on total parenteral nutrition (“TPN”) for several more days before the patient can be weaned off TPN and slowly introduced to normal foods.
Other treatment options may include implantable devices designed to aid in the closure of the fistula. These devices, however, may cause adverse immunological reactions in patients, may allow leakage of fluid around them, or may migrate or become dislodged when the patient exerts himself, such as during exercise. There is a need in the art for an implantable device for closing a fistula that reduces the chance of adverse immunological reactions, and the leakage of fluid through the fistula tract, and that has a reduced chance of migration or dislodgement during use.
Disclosed herein are implantable fistula closure devices and related kits and methods. In some embodiments, a distal anchor for an implantable fistula treatment device may comprise a suture, and a plurality of foldable members including at least a distal-most foldable member and a proximal-most foldable member, wherein the distal-most foldable member comprises a suture attachment structure, wherein the proximal-most foldable member is configured to couple to a surface of a body lumen at a distal opening of a fistula, wherein the proximal-most foldable member is configured to occlude the fistula at the distal opening, wherein the proximal-most foldable member is configured to slide along the suture attached to the suture attachment structure, wherein the proximal-most foldable member comprises a proximal first average dimension substantially parallel to a longitudinal axis of the suture, a proximal second average dimension orthogonal to the proximal first average dimension, and a proximal third average dimension orthogonal to the proximal first and second average dimensions, the proximal first average dimension being no greater than 10% of the greater of the proximal second and third average dimensions, and wherein the distal-most foldable member comprises a distal first average dimension substantially parallel to the longitudinal axis of the suture, a distal second average dimension orthogonal to the distal first average dimension, and a distal third average dimension orthogonal to the distal first and second average dimensions, the distal first average dimension being no greater than 30% of the greater of the distal second and third average dimensions. The distal anchor may comprise at least one additional foldable member positioned between the distal-most foldable member and the proximal-most foldable member. The proximal second average dimension of the proximal-most foldable member of the distal anchor may be larger than the distal second average dimension of the distal-most foldable member. The distal second average dimension of the distal-most foldable member of the distal anchor may have less than or equal to 20% of the proximal second average dimension of the proximal-most foldable member.
The proximal-most foldable member of the distal anchor may comprise a generally circular perimeter. The proximal-most foldable member of the distal anchor may comprise a generally concave shape. The distal-most foldable member of the distal anchor may comprise a generally concave shape, and a radius of curvature of the distal-most foldable member may be smaller than a radius of curvature of the proximal-most member.
The distal anchor may comprise coupling members on opposing surfaces of at least two of the plurality of foldable members. The coupling members of the distal anchor may comprise complementary protrusions or recesses on the surfaces of the members. The complementary protrusions of the distal anchor may comprise teeth. The coupling member of at least one foldable member of the distal anchor may comprise a curing agent. The coupling member of the at least one foldable member of the distal anchor may comprise a capsule enclosing the curing agent. The capsules of the distal anchor may be configured to rupture upon contact with another foldable member. The coupling members of at least two foldable members of the foldable members may be configured to produce attracting electromagnetic forces.
Each of the foldable members may decrease in flexibility from the proximal-most to the distal-most foldable member. The proximal first average dimension of the proximal-most foldable member may be less than the distal first average dimension of the distal-most foldable member. A density of the proximal-most foldable member of the distal anchor may be less than a density of the distal-most foldable member.
A proximal surface of the proximal-most foldable member of the distal anchor may comprise a grapple configured to attach the proximal-most foldable member to a surface of the body lumen. A distal surface of the proximal-most foldable member of the distal anchor may comprise a grapple activation structure configured to activate the grapple upon contact with the proximal surface of another foldable member. The grapple activation structure of the distal anchor may comprises a protrusion.
At least one of the plurality of foldable members of the distal anchor may include a protrusion configured to resist relative movement between at least two of the plurality of foldable members. At least one other of the plurality of foldable members of the distal anchor may include a recess configured to receive the protrusion. At least one of the plurality of foldable members of the distal anchor may comprise at least two protrusions configured to resist relative movement between the at least two of the plurality of foldable members.
The distal-most foldable member of the distal anchor may be pre-attached to the suture at the suture attachment mechanism. The proximal-most foldable member may not be pre-attached to the suture.
In some embodiments, a method of sealing a fistula tract may comprise positioning a first sealing member adjacent a distal opening of a fistula tract at a location outside of the fistula tract and positioning a second sealing member against the first sealing member at a location outside of the fistula tract, wherein at least one dimension of the second sealing member is larger than the first sealing member. The method of sealing a fistula tract may also comprise passing the first sealing member through the fistula tract before positioning the first sealing member at the location outside of the fistula tract. Positioning a second sealing member in the method of sealing a fistula tract may comprise positioning an interfit structure of the second sealing member against a complementary interfit structure of the first sealing member. The method of sealing a fistula tract may comprise positioning a third sealing member against the second sealing member at a location outside of the fistula tract, wherein at least one dimension of the third sealing member is larger than the second sealing member. The method of sealing a fistula tract may comprise positioning a porous body within the fistula tract after positioning the second sealing member against the first sealing member. The method of sealing a fistula tract may comprise tensioning a tether member attached to the first sealing member to deform an aggregate distal anchor comprising the first and second sealing members toward the distal fistula tract. The method of sealing a fistula tract may comprise sealing the aggregate distal anchor at an outer edge seal and an inner seal that is spaced apart from the outer edge seal. The method of sealing a fistula tract may comprise securing the tether to maintain the tensioning of the tether member. Securing the tether in the method of sealing a fistula tract may comprise securing the tether to a resilient structure.
In some embodiments, a fistula irrigation catheter may comprise a tubular member, where the tubular member may comprise a proximal end, a distal end and a wall portion therebetween, the wall portion having a plurality of apertures therethrough, wherein the distalmost aperture of the plurality of apertures is located at least about 2 centimeters from the distal end of the tubular member, and wherein the plurality of apertures are oriented to provide non-orthogonal irrigation therethrough. The plurality of apertures of the fistula irrigation catheter may be configured to provide bidirectional irrigation. The fistula irrigation catheter may also comprise a brushing member configured to brush a fistula tract.
In some embodiments, a method of irrigating a fistula tract comprises inserting an irrigation catheter into the fistula tract, grasping both a proximal end of the irrigation catheter and a distal end of the irrigation catheter, and moving the irrigation catheter proximally and distally within the fistula tract to irrigate different portions of the fistula tract. The irrigation catheter of the method of irrigating a fistula tract may comprise a brushing member, and the method may comprise brushing the fistula tract.
While multiple embodiments are disclosed, still other embodiments fistula treatment devices, kits and methods will become apparent to those skilled in the art from the following Detailed Description. As will be realized, the devices, kits and methods are capable of modifications in various aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
Fistula tracts 10 can be nonlinear or curvilinear and contain cavities of varying sizes at different intervals within the tract. Fistulas may also comprise multiple interconnected passages. An implantable fistula closure device 5 disclosed herein employs advantageous design, configuration techniques and attributes to accommodate such constraints.
For example, and referring to
In certain embodiments, when the body 13 expands to fill the fistula tract, the device may generally stop, resist or slow fluid flow from the bowel from running out through the fistula tract. The device may do this by occluding the distal end of the tract via a distal end of the device body 13 that is generally non-porous or has an ability to seal the distal end of the tract. However, generally speaking, a fistula tract will leak fluid from within the tissue walls surrounding the fistula tract. Some of this fluid will be absorbed by the device. The remaining fluid will drain out of the proximal end of the tract, potentially through the proximal end of the device body 13, which is generally porous or has the ability to allow the passage of fluids while generally occluding or filling the tract.
The time to closure and the necessity for surgery may be reduced (e.g., significantly) by preventing or reducing bodily fluids that originate at the distal end of the tract (e.g., bowel fluids) from passing through a fistula tract 10 and, in some embodiments, also by reducing the amount or rate of flow through the fistula tract for body fluids originating in the tract itself. In certain embodiments, the devices 5 disclosed herein may reduce or eliminate the passage of fluids through the tract 10 while also providing a matrix that promotes tissue growth. The devices 5 may be utilized to treat a variety of clinically significant fistulas 10, as appropriate, including enterocutaneous fistulas, anal fistulas, bronchopleural fistulas, non-healing g-tube tracts, tracheal-esophageal fistulas, and others.
Referring again to
As can be understood from
In some embodiments, the spaced-apart distances D between adjacent proximal and distal ends 25, 30 of the bodies 15 in a compressed or non-expanded state are between approximately zero percent and approximately two and one-half percent of the overall non-expanded length L of a body 15. Where the distance D between immediately adjacent bodies 15 is approximately zero percent of the length L of a body 15 when the bodies 15 are in a non-expanded state, the bodies 15 will be said to be in an abutting or touching configuration, as opposed to a spaced-apart condition. The device body 13 will still be considered to be segmented, however, on account of the device body 13 being formed of a plurality of individual porous bodies 15.
Regardless of whether the bodies are in a spaced-apart configuration or an abutting or touching configuration when the bodies 15 are in the compressed state, the segmented configuration of the device body 13 facilitates the device body 13 being inserted in and conforming to the tortuous diametrically varied route formed by the tract 10.
As can be understood from
While a segmented body 13 has been described, some embodiments of tissue treatment devices may comprise a non-segmented body (i.e., a body 13 that is a continuous, single-piece body 13 as opposed to being formed from multiple bodies 15).
Any suitable methods may be used to deliver or deploy the fistula treatment devices described herein.
In one embodiment, and as illustrated in
In another embodiment, and as shown in
In some embodiments, a catheter comprising a peel-away sheath may be used. For example, a skive, score, partial cut, mechanical joint or formed groove may create a longitudinally extending stress concentration for causing the catheter to peel along the stress concentration.
In certain embodiments, the delivery device 900 may be tracked over a guidewire 901 with the fistula occlusion device 5 residing in the main lumen. Once properly positioned in the fistula tract, the delivery device 900 can be removed from about the closure device 5. The removal of the delivery device 900 from about the closure device 5 may be accomplished by grasping an exposed portion of the delivery device 5 or a grasping member, for example, and then pulling or pushing the delivery device relative to the closure device 5. Alternatively, a hooked member having a hook or other engagement feature that engages an end of the delivery device 900 may be employed where the hooked member can be used to pull the delivery device 900 from about the closure device 5.
In other embodiments, the device 5 may be deployed via a guidewire with a hook-like feature at one end. Such a delivery device can be used for an anal fistula 10, where there is access at both a proximal and a distal end of the fistula tract 10 (in contrast to an enterocutaneous fistula, which has one external access point). The guidewire with the hook-like feature may be inserted into the fistula tract at a first end and passed through the tract 10 such that it can be used to pull the device 5 through the tract 10 by the hook to a second end. The distal end of the device 5, which may already be in an expanded state, may anchor the device 5 into the fistula tract. This embodiment of the delivery device may reduce the amount of work required of the surgeon as the hook may be used to pull the delivery device into place. In an additional embodiment, a guidewire or stylet may be extended through the device body 13 generally parallel to the connecting member 20. In other words the device body 13 may be threaded onto the guidewire or stylet. The guidewire or stylet may then be used to negotiate the device body 13 into the tract 10. Once positioned in the tract 10, the stylet or guidewire may be withdrawn from the device body 13. Where the device body 13 is threaded onto the stylet or guidewire, the bodies 15 may have holes therein for receiving the stylet or guidewire. Also, the bodies 15 may have slots through their sides that lead to the holes so the stylet or guidewire can be inserted into the holes without having to be placed therein via a threading motion. In versions of such embodiments, the slots and/or holes in the bodies 15 for receiving the stylet or guidewire in a threaded arrangement are configured to close after the stylet or guidewire is withdrawn from the bodies 15. The closure of the slots and/or holes may result from the expansion of the bodies 15.
Regardless of whether a catheter, sheath, guidewire or stylet or combination thereof is used to deploy the device 5 in the tract 10, once located within the tract 10, the device body 13 will begin to expand and fill the voids of the tract 10. Expansion of the bodies 15 may be a result of being free of the constraints of the lumen of the sheath, catheter or guidewire used to deliver the device 5. Expansion of the bodies 15 may be a result of being free of the constraints of a restraining mechanism such as a biodegradable ring, sheath, member, etc. extending about the bodies 15 when first deployed in the tract 10. Expansion may be a result of being exposed to body fluids or temperature within the tract 10. Expansion may be a result of any one or more of these aforementioned expansion methods.
As can be understood from
In a manner similar to that discussed above with respect to the distal most body 110, the proximal most body at the proximal end 31 of the device 5 may be adapted and configured to anchor or otherwise hold the device 5 in place within the fistula tract. Where both the distal and proximal most bodies are so configured, the distal and proximal most bodies will provide a counter force or counter balance to each other through the connecting member 20. In some embodiments, the proximal most and/or distal most bodies may be or include an adhesive layer to further strengthen the seal around the respective fistula tract openings.
For a discussion of distal most or proximal most bodies 15 having shapes other than generally cylindrical, reference is made to
In some embodiments, the conically shaped most distal body 120 is generally shaped such that its distal end 125 is generally greater in diameter than its proximal end. The distal end 32 of the device 5 may be advanced into the distal opening 12 of the fistula tract 10 such that a distal portion 125 of the body 120 extends from the tract opening 12 into, for example, the bowel lumen. As illustrated in
In some embodiments, the difference in diameter of the distal end 125 could be a result of a difference in the distance by which the different parts of the distal body 120 can expand. For example, the diameter of the cylinder in the compressed or non-expanded state is uniform; however, when the cylinder expands, the proximal end of the cylinder may reach the wall of the fistula tract 10, while the distal end may have a greater distance to expand before reaching the wall of the fistula tract 10 which corresponds to its target area of expansion. In this case, the diameter of the cylinder in a non-expanded state is uniform, but the diameter of the cylinder in the expanded state forms a conical shape.
In
The expandable member 200 may have any appropriate configuration, and in some cases may include a gel-filled or otherwise readily deformable member sandwiched between a pair of generally rigid discs. In some embodiments, the expandable member 200 may be shaped like a wagon wheel, with the outer rim being the sealing part and the spokes helping to distribute air and/or any other suitable inflation fluids. The expandable member 200 may, for example, comprise a generally flat and circular configuration, or may be thicker and non-circular, including oval or rectangular shaped devices. Although the expandable member 200 is depicted as comprising a generally planar configuration, in other variations, the expandable member may comprise a concave proximal surface and a convex distal surface, which can resiliently deform toward a flattened or everting configuration
The expandable member 200 may be configured to be collapsed for delivery to the target location and to re-expand when deployed. In some examples, the expandable member 200 may comprise a resilient material that re-expands upon removal of any restraint acting on the collapsed body, such as the removal or withdrawal of a delivery catheter, or the cessation of suction or vacuum acting on the collapsed body. For example, the body may be molded (e.g., injection or blow molded) using polyurethane, polyvinyl chloride or any other suitable resilient polymeric material into its base configuration that may then be collapsed using suction or vacuum. In some examples, the expandable member 200 may comprise a shape-memory or superelastic material, including but not limited to nickel-titanium alloys or shape-memory polymers. In other examples, re-expansion may be facilitated by the infusion or inflation of a liquid or gas into the expandable member 200. The expandable member 200 may generally comprise any suitable material or materials. For example, in some cases the expandable member 200 may comprise one or more biocompatible polymers and/or one or more biodegradable or bioabsorbable materials. Expandable members are described, for example, in U.S. Patent Application Publication No. US 2010/0228184 A1, which is incorporated herein by reference in its entirety.
As shown in
In some embodiments, the expandable member 200 may comprises at least one inflatable balloon, chamber or cavity. The inflatable balloon may, for example, be advanced in a non-inflated state through the distal opening 12 of the fistula tract 10. Once in position, the balloon may be inflated (e.g., via a lumen in the connecting member 20) with a material such as air or saline, or another biocompatible fluid or solidifying gel. The balloon may be a fluid-inflatable or expandable disc-shaped balloon adapted to occlude the distal tract opening. Alternatively, the balloon may be a fluid-inflatable or expandable flat cone-shaped balloon adapted to occlude the distal tract opening. Other suitable shapes or configurations may also be used, e.g. a curved configuration with a distal convex surface and a proximal concave surface, as mentioned earlier. Tension may then be applied to the device 5 via the connecting member 20, to thereby cause the balloon to occlude the distal opening 12 of the fistula tract 10. In some variations, the expandable member 200 may be sufficiently resilient to achieve its expanded configuration when any collapsing force or structure is removed, but wherein the inflation chambers may be used to alter the resiliency, rigidity or other mechanical characteristics of the expandable member.
In some embodiments, one or more actuation mechanisms may be used to expand the expandable member 200, while in other embodiments, the expandable member 200 may be expanded without any actuation mechanisms. For example, the expandable member 200 may expand upon exposure to body fluids or a temperature differential within the tract 10, or via its own biased nature. In addition to the expandable member 200 expanding to anchor the device 5, the device body 13 expands to generally fill the rest of the fistula tract 10 as described above, and as depicted in the progression from
In some embodiments of a fistula closure device 5 equipped with an expandable member 200, the device 5 and its expandable member 200 in a non-expanded state are configured to pass through a lumen of catheter size of nine French or smaller, and in some embodiments, twenty French or smaller.
In certain embodiments, the expandable member 200 may comprise an adhesive coating adapted to adhere to the tissue surface of the region adjacent the distal opening 12 of the fistula tract 10, while in other examples, the adhesive may be light curable, where the light is provided via a fiberscope inserted into the fistula tract (with or without the delivery tool or a cannula in place), or in some variations, via the lumen of the gastrointestinal tract. The adhesive may activate after exposure to a fluid (e.g., body fluid) or body temperature. The adhesive may initially strengthen the bond of the member 200 to the tissue and then gradually degrade in strength as fistula tract healing occurs or after fistula tract healing. Depending on the embodiment, the adhesive may create a fluid impermeable seal for at least 7, 14, 21, 28, 35, 60 or any other number of days.
In certain embodiments, an expandable member 200 may include attachment members, such as micro hooks or tines. Such attachment members may be located on a surface of the expandable member 200 intended to contact the tissue surface area forming the opening 12, thereby facilitating the adherence of the expandable member to the tissue surface bordering the distal tract opening and the occlusion thereof.
In some embodiments, an expandable member 200 or various components thereof may be resorbable and adapted to occlude the fistula tract and then resorb after the tract 10 has closed at least about 45%, 55%, 65%, 75%, 85%, 95%, 100% or any other percentage. The expandable member 200 or various components thereof may be biodegradable and/or adapted to fall away from the distal fistula opening 12 and be extruded through the gastrointestinal tract. For example, the expandable member 200 or various components thereof may be secreted from the body after the tract 10 has progressed towards closure (e.g., after at least 7, 14, 21, 28, 35 or any other number of days adequate to achieve sufficient closure).
In some embodiments, the connecting member 20 may be a biocompatible polymer string extending through the tract from the expandable member 200. The connecting member 20 may be formed of one or more resorbable materials and may resorb after the tract 10 has closed at least about 45%, 55%, 65%, 75%, 85%, 95%, 100%, or a percentage range between any two of the above percentages. The connecting member 20 may provide tensile force substantially perpendicularly to the expandable member 200, thereby pulling the expandable member 200 against the tract's distal opening 12 and anchoring the expandable member 200 in place to occlude the distal tract opening.
Expandable members or components 200 may have any suitable shape or configuration, and may be actuated using any appropriate mechanism. In some cases, a plugging mechanism may be used to seal an expandable member 200 (e.g., after the expandable member has been positioned at a target site and expanded). For example,
In
While plug members comprising elongated members and plug portions have been described, other embodiments of plug members having different components and/or configurations may also be used, as appropriate. For example, a plug member may comprise multiple plug portions and/or a plug portion having a different configuration.
Once the expandable member 20 has been expanded, it may be used to seal the distal opening of a fistula tract.
As discussed above, in some embodiments of the device 5, the proximal end of the device may be adapted and configured to receive a proximal clip that secures the device in place. The clip may, for example, be disc-shaped, or may have a different (e.g., polygonal) shape. The clip may be made of any biocompatible material, such as PGLA, PVA or PVC, or any other suitable biocompatible polymer or plastic. The material may also be resorbable. In use, the clip may extend across the proximal end of the fistula tract 10 and may be generally flush or slightly raised relative to the proximal end of the fistula tract 10. The clip may help to maintain tension on the connecting member 20 that couples the expanding member 50 with the clip, thereby helping to maintain or anchor the device 5 in the tract 10. The clip may be coupled to the connecting member 20 in any appropriate fashion, such as via friction, pinching, suturing or any other suitable method.
Features of the clip and/or proximal end 31 of the device 5 may be transparent to allow visual inspection of the tract. In some embodiments, the clip and/or proximal end of the device may be adapted to cover the proximal end of the fistula tract without completely sealing the proximal end of the tract, thereby allowing accumulating fluids to drain or escape from the proximal end of the tract. In some cases, the clip may comprise a mesh-like membrane that permits drainage of accumulating fluids from the proximal end of the tract. After the tract 10 heals, the proximal clip may resorb or otherwise be removed.
Referring back to
In
In use, the proximal anchor 250 may be slid onto one or both of the tethers and positioned adjacent the skin surface (e.g., after the expandable members 15 have been expanded in the fistula tract 10 by, for example, infusing saline into the fistula tract). While maintaining tension on the tension tether 254 through the proximal anchor 250, the delivery tether 256 may be sutured or otherwise attached to the surrounding tissue using a free needle passed through the proximal anchor 250 and tied to the tissue with the desired tension. At a location opposing the delivery tether 256 on the proximal anchor 250, a free needle may be used to pass through the proximal anchor 250 and to suture the tension tether 254 to the surrounding tissue. Additional sutures (e.g., 3-0 or 4-0 nylon) may be used to further secure the proximal anchor 250 to the surrounding superficial tissue as needed.
The size and shape of the proximal anchor 250 may depend, for example, upon the particular fistula being treated. In some embodiments, the proximal anchor 250 may have a diameter or maximum transverse dimension that is at least the same as that of the expandable member 200. In further examples, the diameter or maximum transverse dimension may be at least two times, three times, or four times or greater than the corresponding dimension of the expandable member 200. The expandable member 200 and the proximal anchor 250 may both have the same shape (e.g., circular) or may have different shapes.
The proximal anchor 250 may also comprise one or more securing apertures 258 that may permit the attachment of the proximal anchor 250 to the skin or a bandage surrounding the dermal fistula opening. These securing apertures 258 may be spaced around the periphery of the proximal anchor 250, closer to the outer edge rather than the center of the proximal anchor 250. Any suitable number of apertures having any appropriate size may be used. In other examples, the proximal anchor 250 may comprise an adhesive surface that contacts the skin surrounding the fistula and resists movement. The tethers 254 and 256 of the device may be secured to the proximal anchor 250 by any of a variety of mechanisms, including a clamping structure, adhesive, or by a deformable slit that provides a releasable friction fit interface for the tethers 254 and 256. The attachment site of the tethers 254 and 256 on the proximal anchor 250 may further comprise access openings that may be used to infuse therapeutic agents into the fistula, and/or to permit passive or active fistula drainage, or the application of negative pressure therapy to the fistula.
During use, when the first and second portions 260, 262 are coupled to a tether, the first and second portions can move relative to each other to accommodate changes in the length of tether between them. For example, movement by the patient may necessitate having a lesser or greater length of tether between the first and second portions. The ability of the first and second portions to move relative to each other may allow for such a change to take place without, for example, resulting in tether breakage or excessive tether slackness. While the first and second portions 260, 262 of the proximal anchor 250 of
It should be noted that any of the proximal anchors described herein may be configured to allow for negative pressure transmission (e.g., negative pressure wound therapy), as appropriate. For example, the proximal anchors may include one or more apertures configured for negative pressure wound therapy. A vacuum pump may be applied to suction out fluid and/or collapse dead space to facilitate healing.
Referring to
The first and second portions 702, 704 of the proximal anchor 250 comprise protruding members or pegs 706 through which at least one tether (here, the tension tether 254) may be routed. Additionally, the proximal anchor 250 comprises a tether clamp 711 that may be used to lock or secure the tether 254 at a proximal location 715. During use, the first and second portions 702, 704 may slide away from each other (in the directions of arrows 706, 708) and toward each other, to accommodate for variations in the length of tether extending from the skin surface. For example, in
As discussed above, methods described herein employ expandable members 15 to fill a fistula tract. Different expandable members 15 and arrangements thereof may be used with the devices, methods and kits described herein, as appropriate.
In some embodiments, the expandable members 15 of the device 5 may comprise porous bodies. For example, the expandable members 15 may comprise a compressed open cell polymer and may be made of any synthetic or natural biodegradable, resorbable, biocompatible polymer or polymers, such as collagen, hyaluronic acid and polyglycolic acid (“PGA”). The biodegradability may allow for degradation at a specified rate that matches the rate of tissue ingrowth and fistula tract healing, such that by the time the fistula tract is healed, the material is completely absorbed by the body. It should be noted that in some cases, the fistula tract may heal before the material is completely absorbed by the body. That is, the degradation rate of the device may not match, or may be slower than, the rate of tissue ingrowth and fistula tract healing.
Expansion of the bodies 15 within the tract 10 provides a porous scaffold to the fistula tract and may partially or entirely stop the flow of bodily fluids through the tract. The scaffold provides a matrix that may promote tissue in-growth, allowing the fistula to close. In certain embodiments, one or more antimicrobial agents, such as silver, may be incorporated in the porous bodies 15 and/or in the insertion methodology to actively prevent infection and/or sepsis formation and aid in the healing of the tract. The porous bodies 15 may include wound-healing agents, such as growth factors. In some embodiments, the porous bodies may include fibrosis-promoting agents.
A porous body may be adapted and configured to expand after placement in the fistula tract and to absorb fluid, thereby approximating closely the tract intra-luminal walls. In some embodiments, a porous body may include a porous resorbable open cell polymer foam adapted to expand and serve as a scaffold for tissue growth and closure of the fistula tract.
In certain embodiments, a porous body may comprise collapsed or compressed pores, adapted and configured to increase in size after placement in a fistula tract, thereby filling the fistula tract. In some embodiments, the pores of the bodies may advantageously be of a reduced size. For example, pore size may vary from 5 to 1000 microns with an overall porosity of 25-95%. In certain embodiments, bodies with a controlled pore size (i.e., without a broad distribution of pore sizes) of between approximately 50 microns and approximately 100 microns may be used. A body with a controlled pore size may promote greater angiogenesis, which, in turn, may promote better wound-healing. Examples of materials that may provide some or all of the controlled pore size and porosities include various biomaterials manufactured by Kensey Nash Corporation, CollaPlug® or other collagen products as manufactured by Integra Corporation, and STAR® materials as manufactured by Healionics Corporation.
In some embodiments, the fluid permeability (i.e., porosity or pore size) of the bodies 15 may increase from the distal end of the device 5 to the proximal end of the device 5. For example, a first body 15 at the distal end of the device 5 may have a lower fluid permeability than other bodies 15 of the device 5. That is, in a segmented body 13, a most distal body 15 or the most distal several bodies 15 (i.e., the single body 15 or the few multiple bodies 15 in closest proximity to the distal end of the tract, e.g., at the bowel end of the tract) may have the lowest fluid permeability and the bodies 15 extending proximally away from the most distal body 15 may have a higher fluid permeability. In certain embodiments, the fluid permeability of the bodies 15 proximal to the most distal body or bodies 15 may increase from body to body, moving in the proximal direction. A most distal body 15 or bodies 15 with a lowest fluid permeability may further enhance occlusion of the distal end 12 of the fistula tract 10 and prevent unwanted fluid from the bowel from entering the fistula tract. The bodies 15 proximal of the most distal body 15 or bodies 15 may have a higher fluid permeability to permit drainage of fluids accumulating in the tract and to promote tissue ingrowth to facilitate healing of the fistula tract.
A non-segmented body 13 may have a fluid permeability (i.e., porosity or pore size) that changes along its length. For example, the distal portion of the non-segmented body 13 may have a lower fluid permeability as compared to the proximal portion.
The porous bodies 15 may be in the form of polymer members that are anisotropic. For example, in some embodiments, the polymer members 15 may be anisotropic such that they have substantial radial expansion, but minimal, if any, longitudinal expansion.
In certain embodiments, the porous bodies 15, when in a compressed or non-expanded state, may have a volume that is significantly less than the volume of the bodies 15 when in a non-compressed or expanded state. For example, in some embodiments, the compressed or non-expanded volume of the bodies 15 may be between approximately 10% and approximately 60% of the non-compressed or expanded state volume. In certain embodiments, the compressed volume may be between approximately 20% and approximately 25% of the expanded volume. As a result, the bodies 15 may expand between approximately four and approximately five times their compressed volumes when expanding from a compressed state to an expanded state. For example, a body 15 with a porosity of 80% can be compressed to 20% of its expanded state. In other words, the body 15 may expand approximately five times its compressed volume when expanding from a compressed to a non-compressed state. The body 15 may expand even more if it retains any absorbed fluid from the fistula tract 10.
The porous bodies 15, when in a compressed or non-expanded state, may be relatively easy to insert in a fistula tract 10 and may cause less damage upon insertion due to the reduced size. The compressed porous bodies 15 also may allow for controlled expansion. In other words, the expanded size of a compressed porous body 15 is generally known and may be chosen and optimized based upon the configuration of the fistula tract 10. Thus, use of a compressed porous body 15 may permit greater occlusion of the fistula tract 10 because the compressed porous bodies 15 conform to the tract 10, as opposed to making the tract 10 conform to the body of the device. The porous bodies 15 also may not require fluid to expand or to be maintained in an expanded state. Such controlled expansion porous bodies 15 may be formed of hyaluronic acid, hyaluronic acid mixed with collagen, or any other suitable materials that offer control or specific pore size or porosity.
In some embodiments, the controlled expansion of the bodies 15 may be a function of precompressing the bodies 15 a certain extent (e.g., approximately 80 percent of their non-compressed state) and then releasing the bodies 15 to resume their non-compressed state. Thus, it is possible to readily determine the final fully expanded condition of the bodies 15 because they may only expand to their non-compressed state upon being released to resume the non-compressed state.
As mentioned above with respect to
As shown above in
In some embodiments, the device 5 may be configured to fill multi-tract fistulas. For example, the device 5 may comprise multiple device bodies 13 joined together at a common point of the device 5. In other words, the device may have at least two chains of porous bodies 15 joined together to allow a segmented device body 13 to be inserted into each of the tracts 10 of a multi-tract fistula. Alternatively, at least two chains of porous bodies 15 may be joined together to create a device 5 with at least two segmented device bodies 13.
In certain embodiments (not shown), the porous bodies 15 may also include attachment members that are configured to attach and engage the bodies 15 with the tract 10, and that deploy when the bodies 15 are in a non-compressed or expanded state. The attachment members may be unidirectional (e.g., comparable or similar to a fish hook barb) or may have a compressed fishbone-like structure and may be made of any appropriate biocompatible, resorbable material. The attachment members may permit outward removal but not inward traction. That is, when the attachment members are deployed, the bodies 15 may be retracted towards the proximal end without damaging the fistula tract 10, but the bodies 15 may be engaged with the tract 10 such that they will not migrate towards the distal end 12 of the tract 10.
As can be understood from
In certain embodiments, the bodies 15 of the fistula closure device 5 may be formed from materials other than a graft, wherein graft is defined as a transplant from animal or human tissue.
In some embodiments, the bodies 15 of the fistula closure device 5 may be formed from materials other than an extracellular matrix (“ECM”) material, wherein ECM material is defined as decellularized organic tissue of human or animal origin. Furthermore, in some such embodiments, the bodies 15 of the fistula closure device 5 may be formed from materials other than those that are remodelable, where remodelable is defined as the ability of the material to become a part of the tissue. Instead, in some embodiments, the bodies 15 of the fistula closure device 5 may rely heavily on the amount of induced cross-linking that allows control of the resorption rate. Cross-linking essentially destroys the remodelable properties of a material. While remodelable may not exclude resorbable material completely, in some embodiments, the bodies 15 of the fistula closure device 5 may be formed of material that is completely resorbable and has no remodelable requirements or capabilities.
In some embodiments of the fistula closure device 5, the device body 13 may be formed of multiple bodies 15 to form a segmented body 13. The body 13 may include a distal occlusion member 200 (e.g., an umbrella-like member), the member 200 acting as an occlusion mechanism that is more of an occlusive cover rather than a plug or sealing member.
The fistula closure devices 5 as described herein may be implanted into a fistula tract 10 via various methods. For example, the fistula tract 10 may be visualized via direct visual inspection or medical imaging methods (e.g., Fluoroscopy, CT scan, MRI, etc.). A guidewire may be negotiated through the tract 10. The tract 10 may then be de-epithelializing irrigated. The device 5 may then be threaded over the guidewire and pushed into the tract 10. The distal fistula opening 12 may be occluded via elements of the device 5 (e.g., the most distal body 110 and/or expandable member 200). The device 5 may be trimmed to the length of the tract 10, after which the guidewire is removed. The device 5 and, more specifically, the device body 13, may be irrigated to cause expansion of the body 13. The device 5 may be anchored at the proximal fistula opening with a proximal end piece. For example, a retaining member may be connected to the distal end of the device 5 and secured to the region surrounding the proximal end opening of the tract 10, thereby creating tension in the device 5. The proximal fistula opening may then be covered with a dressing.
In another method of implanting the fistula closure device 5 in a fistula tract 10, a compressed porous scaffold 13 is placed in the fistula tract 10, wherein the scaffold 13 is at least partially inserted into the tract 10. The porous scaffold may be filled with, for example, an injectable polymer fluid, which may form an occlusive plug and may promote tissue growth and hence healing of the fistula tract. The method may further include fixating the device 5 in the tract 10 using a biocompatible connecting member 20, such as a string, which is attached to the device 5. The polymer injected into the tract 10 may be in a form that allows the foam to approximate the walls of the fistula tract 10 and fill any voids in the tract.
In another method of implanting the fistula closure device 5 in a fistula tract 10, a distal end 32 of the device 5 may be placed in such a way as to protect and occlude the distal end 12 of the fistula tract 10. The body 13 of the device 5 may be inserted into the fistula tract 10 in such a way as to at least partially fill the fistula tract 10. The surface load or point load dependent expansion of porous bodies 15 may then be activated within the fistula tract and the device 5 may be anchored in place at the distal and/or proximal ends 32, 31. For purposes of this disclosure, surface load or point load dependent expansion refers to the expansion of the porous bodies where, upon contact between the fistula tract wall (the “load”) and a point on the porous body, that point of the porous body will stop expanding. The points on any or all of the rest of the porous body will continue to expand until the remaining points also make contact with the fistula tract wall. Thus, the surface load or point load dependent expansion of the bodies 15 of the device 5 disclosed herein allows the body 13 to generally fill and conform to the tract 10 without distorting the tract 10 or causing the tract to conform or deform due to the expansion of the body 13 in the tract. This ability of the body 13 can be a result of pre-compression of the body 13 and/or the nature of the material used.
Examples of materials from which to form the bodies 15 of the device 5 include: AngioSeal-like products, collagen sponge or other biomaterial materials as manufactured by Kensey Nash Corporation (Exton, Pa.); CollaPlug® or other collagen products as manufactured by Integra Corporation (Plainsboro, N.J.); and STAR® materials as manufactured by Healionics Corporation (Redmond, Wash.). With respect to the CollaPlug® material, in some embodiments, the CollaPlug® material may be compressed prior to delivery into the tract 10, the CollaPlug® material being approximately 90% porous. With respect to the STAR® materials, some such materials are known to have a specific pore size that promotes better angiogenesis. The STAR® materials and some of the materials and products discussed above may be capable of achieving a desirable controlled pore size and overall porosity for purposes of the devices and methods disclosed herein.
In another method of implanting the fistula closure device 5 in a fistula tract 10, the tract may be visualized and a guidewire may be routed into the tract. The tract 10 may be de-epithelialized and irrigated to remove any unwanted internal matter. The fistula closure device 5 may be tracked over the guidewire and the device 5 may then be received into the fistula tract until the distal end of the device 5 extends beyond the distal fistula opening 12. The device 5 may be expanded by irrigation so as to approximate the fistula tract 10. The device 5 may be trimmed if required. The method may include clipping or otherwise securing the proximal end of the device 10 at the proximal tract opening to provide a secure anchor. The proximal opening may then be covered with a dressing. In one embodiment, the segmented body 13 of the device 5, when in an expanded state, generally approximates the volume of the fistula tract with minimal distortion of the fistula tract.
As further depicted in
The sealing body 1302 may further comprise an attachment structure 1320 to facilitate delivery of the sealing body 1302. The delivery catheter, if any, may releasably engage the sealing body 1302 at the attachment structure 1320. The attachment structure 1320 may also be the attachment site for one or more tethers or sutures that may be used in conjunction with the sealing body 1302. In some further examples, the attachment structure 1320 may be located centrally with respect to the overall shape of the sealing body 1302, but in other examples the attachment structure 1320 may be eccentrically located. The attachment structure 1320 may be integrally formed with the access lumen 1314, or may be separate from the access lumen, which may be used to inject materials into the hollow lumens and/or cavities of the support structures 1312 and the annular seal 1310, if any. In other examples, through lumens in the body may permit access to the intestinal lumen for fluid sampling, placement of sensors, and/or therapeutic agent delivery.
Referring to
It should be understood that features and characteristics described herein with reference to specific expandable members 200 and sealing bodies 1302 may be applied to any of the other expandable members and sealing bodies described herein, as appropriate.
As shown in
In one exemplary delivery procedure, the fistula tract and surrounding area may be prepped and draped in the usual sterile fashion. Anesthesia may be achieved as needed using topical and/or injectable anesthetics. The fistula tract may then be irrigated with sterile saline, hydrogen peroxide or any other suitable biocompatible irrigation fluid. In some further examples, portions of the fistula tract may be de-epithelialized using silver nitrate sticks, cautery and/or mechanical debridement using a scalpel, for example. The delivery instrument may be removed from its aseptic packaging and placed onto a sterile field. To reduce the risk of dislodging the sealing body 1302, tensioning of the attached sutures 1424 and 1426 may or may not contraindicated. Various extension tubes and stopcocks, if any, may be attached to the delivery instrument 1550 at this time. Flushing, patency/leakage testing of the delivery instrument connections may be performed using saline or similar fluid. The integrity of the sealing body 1302 may also be assessed using saline, contrast agent or a mixture of both and the application of positive and/or negative fluid pressure through the delivery instrument 1550. Prior to delivery, the sealing body 1302 may be evacuated with negative pressure to collapse the sealing body 1302. The same or a separate syringe of saline, contrast agent or combined fluid may be prepared as an inflation syringe for the sealing body.
The fistula tract may be traversed using a guidewire, with or without the assistance of imaging modalities such as plain X-ray, fluoroscopy, CT scanning, endoscopy, or ultrasound, for example. The peel-away sheath may be passed over the guidewire and through the dermal ostium of the fistula tract. A dilator may be used as needed to prepare the fistula tract for passage of the delivery instrument and/or endoscopic instrument. The position of the sheath may be verified with the same or different imaging modality. The procedure may be continued once the desired sheath tip location is achieved or verified, e.g. the distal tip is located beyond the intestinal or central ostium of the fistula tract. The guidewire (and dilator, if any) may then be removed. The sheath may be flushed with sterile saline. The collapsed sealing body 1302 may be wrapped around the distal end of the delivery instrument 1550 by rolling, rather than collapsing the sealing body 1302 like an umbrella. The delivery instrument 1550 may be inserted into the sheath and advanced until the sealing body 1302 is located beyond the distal tip of the sheath. The relative location of the delivery instrument 1550 may be evaluated by imaging, by the distance between proximal ends of the sheath and delivery instrument, and/or by the loss of insertion resistance that may be tactilely felt once the sealing body 1302 has exited the sheath. A 10 cc syringe, for example, may be attached to the delivery instrument and negative pressure may be applied to the sealing body 1302 through one of the stopcocks, which then may be closed to maintain the sealing body 1302 in a collapsed state. The syringe may then be removed and is replaced with a syringe of the same or smaller size. The stopcock is re-opened and the evacuation of the sealing body 1302 may be confirmed by pulling back on the syringe and assessing plunger displacement. A portion of the fluid in the syringe (e.g. 0.5 cc) may then be injected into the sealing body 1302 to inflate it. The stopcock may be closed to maintain the inflation.
While maintaining the position of the delivery catheter (or the Touhy Borst valve), gentle traction may be applied to the tension tether attached to the sealing body 1302 to fully seat the sealing body 1302 to the delivery instrument 1550. The Touhy Borst valve may then be loosened and the sheath may be partially retracted into the fistula tract (e.g., proximal to the central ostium). The sealing body 1302 may then be deployed by disengaging or otherwise separating the lock mechanism between the Touhy Borst valve 1562 and the connector 1556. The remaining distal portions of the delivery instrument 1550 may then be slowly withdrawn from the fistula tract. While maintaining slight tension on the tension tether 1424 to hold the sealing body 1302 against the central ostium of the fistula tract, the sheath may be slid proximal the desired length that is to be filled with the expandable members. Slight tension may be maintained on the tension tether 1424 through the remaining procedure until the tether is anchored to the skin.
The actuator 1572 may be inserted into the plug delivery catheter 1570 until the suture loop 1434 just exits the distal end 1578 of the catheter 1570. The actuator 1572 may then be withdrawn. While maintaining slight tension on the tension tether 1424, the delivery tether 1426 may be threaded through the loop 1434 at the distal end 1578 of the delivery catheter 1570. The catheter 1570 may then be advanced over the delivery tether 1426 until the catheter tip 1578 is located at the desired delivery location. The actuator 1572 may be reinserted into the catheter 1570 until the distal end 1574 of the actuator 1572 contacts the most proximal expandable member 1428 in the catheter 1570. The position of the actuator 1572 may then be maintained while the delivery catheter 1570 is retracted to deploy the distalmost expandable member 1428. The catheter 1570 may or may not be relocated to deploy the remaining expandable members 1428. Once deployment of all the expandable members 1428 is completed, the Luer fittings on the proximal end 1576 of the delivery catheter 1570 and actuator 1572 may be engaged and the catheter 1570 and actuator 1572 may be removed from the sheath. Saline may be optionally infused through the sheath to facilitate expansion of the expandable members 1428. Using separately supplied catheters 1570 and actuators 1572, additional expandable members may be deployed using the above procedure to fill the fistula to the desired level. Sealing body 1302 placement may be reconfirmed by imaging techniques to ensure that the sealing body 1302 is located against the central ostium.
While maintaining tension on the tension tether 1424, the restraining structure 1430 may be separated from the sheath and the sheath may be removed from the fistula tract. While continuing to maintain slight tension on the tension tether 1424 through the restraining structure 1430, the delivery tether 1426 may be sutured or otherwise attached to the surrounding tissue using a free needle passed through the restraining structure and tied to the tissue with the desired tension. At a location opposing the delivery tether 1426 on the restraining structure 1430, a free needle may be used pass through the restraining structure 1430 and to suture the tension tether 1424 to the surrounding tissue. Additional sutures (e.g., 3-0 or 4-0 nylon) may be used to further secure the restraining structure 1430 to the surrounding superficial tissue as needed. Final imaging confirmation of the sealing body 1302 placement along the central ostium may be performed at this point using the imaging modalities as previously described, but also including double-contrast x-ray studies and colonoscopy/enteroscopy. An absorbent dressing may be securely on top of the restraining structure 1430 to absorb any excess drainage that may occur. Alternatively active drainage of the fistula/wound may be performed using wound drainage products or negative pressure wound therapy products. Prophylactic antibiotics may be optionally provided post-procedure.
The size and shape of the restraining structure 1430 may be different depending upon the particular fistula being treated, but in some examples, the restraining structure 1430 may have a diameter or maximum transverse dimension that is at least the same as the sealing body 1302. In further examples, the diameter or maximum transverse dimension may be at least two times, three times, or four times or greater than the corresponding dimension of the sealing body 1302. The restraining structure 1430 may also comprise one or more securing apertures 1436 that may permit the attachment of the restraining structure 1430 to the skin or a bandage surrounding the dermal fistula opening. These securing apertures 1436 may be spaced around the periphery of the restraining structure 1430, closer to the outer edge rather than the center of the restraining structure 1430. In other examples, the restraining structure 1430 may comprise an adhesive surface that contacts the skin surrounding the fistula and resists movement. The tethers 1424 and 1426 of the device may be secured to the restraining structure 1430 by any of a variety of mechanisms, including a clamping structure, adhesive, or by a deformable slit 1438 that provides a releasable friction fit interface for the tethers 1424 and 1426. The attachment site of the tethers 1424 and 1426 on the restraining structure 1430 may further comprise access openings 1440 that may be used to infuse therapeutic agents into the fistula, and/or to permit passive or active fistula drainage, or the application of negative pressure therapy to the fistula.
Referring to
As shown in
The expandable members 1428 may be provided in a rigid or flexible tubular catheter 1570, as depicted in
To perform the procedures described above, a kit may be provided that contains the delivery instrument 1550 along with the sealing body 1302 and attached tethers 1424 and 1426. The sealing body 1302 and attached tethers 1424 and 1426 may be coupled to the instrument 1550 at the point-of-manufacture or at the point-of-use, and therefore may be provided in the kit either pre-attached or separate from the instrument 1550. The kit may also comprise an actuator pre-filled catheter 1570 with one or more expandable members 1428 that are pre-attached with a plug tether 1430. Additional catheters 1570 with expandable members 1428 may be also be packaged and provided separately. In further examples, the kit may also contain one or more other items, including but not limited to a guidewire (e.g. 0.038″ guidewire), a peel-away sheath (e.g. 7F, 8F, 9F, 10F, or 12F sheath), one or more syringes (e.g. 0.5 cc, 1 cc, 5 cc, and/or 10 cc syringes), saline or biocompatible fluid, contrast media, a scalpel, one or more free needles, and non-resorbable sutures (e.g. 3-0 or 4-0 nylon suture) that may be used to attach the restraining structure 1430 to the adjacent skin or to a bandage. A fistula tract dilator may also be provided in the kit.
Fistula treatment devices described herein may in some cases be provided in a kit. The kit may also include any other appropriate devices or components, such as delivery tools or other fistula treatment devices (i.e., a kit may include multiple fistula treatment devices). The contents of a kit may be provided in sterile packages. Instructions may be provided on or with the kit, or alternatively via the internet or another indirect method, and may provide direction on how to employ the kit (e.g., outlining a deployment method such as one of those described herein).
Each foldable member comprises a large dimension (diameter) and a small dimension (thickness). In some variations, the diameter is considerably larger than the thickness. For example, the foldable members of distal anchor 1600 comprise a very large diameter relative to their thickness so that the foldable members take on a “pancake” appearance. In some variations, the small dimension of the foldable members are characterized as percentages of the large dimension, and may sometimes be less than or equal to 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 30%, 40% or 50%, or any percentage range between any two of the above percentages. The foldable members are configured so that the large dimension is oriented generally in parallel to a surface of a body lumen when the foldable members are deployed.
In some variations, the foldable members may reduce in diameter from the proximal-most foldable member 1608 to the distal-most foldable member 1602. The diameter of the distal-most foldable member may be characterized as a percentage from 1% to 100% of the diameter of the proximal-most foldable member 1602, and may sometimes be about 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, or any percentage range between any two of the above percentages. In other variations, the diameter difference may be approximately equal to a percentage between any of the foregoing percentages. The diameters of the inner foldable members 1604 and 1606 may also be characterized as a percentage from 1% to 100% of the diameter of the proximal-most foldable member 1602, and may sometimes be about 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, or any percentage range between any two of the above percentages. In other variations, the diameter difference may be approximately equal to a percentage between any of the foregoing percentages. In some variations, the diameter of the proximal-most foldable member may be sized to occlude a distal opening of a fistula tract. In some variations, the diameter of the proximal-most foldable member may be in the range of about 4 mm to about 50 mm, sometimes about 8 mm to about 30 mm, and other times about 10 mm to about 45 mm, and still other times about 12 mm to about 30 mm. Further, although four foldable members are illustrated in
In some variations, one or more of the foldable members are non-circular. A non-circular outline can be understood to be any shape in which the perimeter is not a constant radius from a center point. Non-circular shapes include shapes with first-derivative discontinuities at one or more locations. Non-circular shapes may also be Non-circular shapes may also be Non-circular shapes a generally circular shape with protrusions or recesses on the perimeter to accommodate a predetermined surface of a body lumen. Non-circular shapes may include, but are not limited to, ovals, ellipses, rectangles, lenses, deltoids, and bell-shapes. When non-circular, a diameter of a foldable member may be understood to mean a length of the member in one dimension. For example, a line taken through a center point or a widest span of the member. In such variations, the diameters of the distal-most and inner foldable members may be characterized as a percentage from 1% to 100% of the diameter of the proximal-most foldable member, and may sometimes be about 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, some of the foldable members take a shape different from one or more of the other foldable members. For example the distal members may be circular, but the proximal-most foldable member may be shaped to occlude a non-circular fistula opening. In some other variations, the distal foldable members are also non-circular in order to achieve a desired distribution of forces, for example.
Suture attachment structure 1612 is illustrated on a distal surface of foldable member 1602, but in some variations is positioned on a proximal surface of distal-most foldable member 1602. When on the distal surface, the suture attachment structure may comprise an aperture to allow the suture to pass through the foldable member and an additional feature to fixedly couple the suture to the foldable member. When positioned on the proximal surface, the suture attachment structure may include a loop or other feature to fixedly couple the suture to the foldable member. In some variations, the suture attachment structure includes a recess on the distal surface of the distal-most foldable member 1602. Distal-most foldable member 1602 may also comprise reinforcing structure (not shown) for the suture attachment structure 1612. In some variations, the reinforcing structure is a wire mesh embedded within distal-most foldable member 1602 and configured to distribute the force resulting from tensioning the suture across all or some of the distal-most foldable member 1602. In other variations, the reinforcing structure might include a button-shaped suture attachment structure, wherein the expanded areas of the button-shaped suture attachment structure serve to distribute the force over a wider area.
In some variations, the foldable members 1604, 1606, and 1608 may include apertures (not shown) to permit the members to slide along suture 1610. Although illustrated in
As described above, the foldable members 1602, 1604, 1606, and 1608 are configured to be released from an insertion device. In some variations, the foldable members are configured to be reduced in size to fit within an insertion rod of a given diameter. For example, one or more of the foldable members may be configured to reduce its cross-sectional profile by folding or rolling, thereby facilitating entry into the insertion rod, as described in more detail later. In some variations, the flexibility of the foldable members may be increased as the diameters increase to facilitate folding or rolling of the foldable members to a predetermined cross-sectional profile for insertion. In some variations, a flexibility of a foldable member may be characterized by a thickness of the foldable member. In some variations, a flexibility of the foldable members may be characterized by its percentage thickness, from 1% to 100%, of the thickness of the distal-most foldable member, and may sometimes be about 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, a flexibility of the foldable members may be characterized by its percentage density, from 1% to 100%, of the density of the distal-most foldable member, and may sometimes be about 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, or any range between any of the two percentages. In some variations, a flexibility of the foldable members may be characterized by its percentage coefficient of resistance to deformation, from 1% to 100%, of the coefficient of resistance to deformation of the distal-most foldable member, and may sometimes be about 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the flexibility of a foldable member may be constant across the member. In other variations, the flexibility of a foldable member may vary across the member by, for example, a variance in the density and/or thickness in different regions of the foldable member. This flexibility variance may be controlled to facilitate folding the member or to facilitate coupling two foldable members.
Foldable members 1602, 1604, 1606, and 1608 are depicted in
Although the geometries described above are generated by a single curve defining both the distal and proximal surface of each foldable member—that is, the foldable member has a constant thickness—other variations may have different curves to respectively define the proximal and distal surfaces. Further, although the curves above are discussed with respect to an (x,y) Cartesian plane, it should be understood that the cross-section of the foldable member may not be positioned in a fistula tract so that the curve remains in that orientation. For example, although a cross-sectional area of a foldable member may be described in (x,y) coordinates so that its first derivatives are at the top or bottom of a curve, in some variations, the foldable member is rotated for insertion so that the minimum point is now at a vertical mid-point.
Further, the curves and shapes described above refer to a general or overall shape of a foldable member, the foldable members may have additional surfaces features. For example, a foldable member's overall shape may be augmented with any of the recesses, protrusions, and coupling members described herein.
As depicted in
Returning to
In some variations, the proximal surface of the proximal-most foldable member may be structured to facilitate a secure and lasting coupling of the distal anchor to the surface of a body lumen. In some variations, the structure may be a grapple, as described herein. In some variations, an adhesive may be added to the proximal surface of the proximal-most member. The adhesive may be applied by a physician before inserting the proximal-most foldable member into the body lumen or applied after insertion. In other variations, the adhesive may be applied during a manufacturing process and covered with a liner. In some variations, the liner is removed by the physician prior to insertion. In other variations, the liner is configured to dissolve upon contact with bodily fluid or after a force is applied to the distal anchor. The adhesive may initially strengthen the bond of the proximal-most foldable member to the tissue and then gradually degrade in strength as fistula tract healing occurs or after fistula tract healing. Depending on the variation, the adhesive may create a fluid impermeable seal for at least 7, 14, 21, 28, 35, 60 or any other number of days. The structure for a secure and lasting coupling may also comprise microneedles, such as hooks and/or barbs. The microneedles may be distributed throughout the proximal surface of the proximal-most member, but may also be distributed at predetermined locations. In some variations, the microneedles are distributed along a perimeter of the proximal surface, but in other variations the microneedles may be distributed at a position where contact is anticipated, such as the inner sealing regions described herein.
In some variations, a drug-eluting or therapeutic agent may be added to the distal anchor or the suture associated therewith. The drug-eluting or therapeutic agent may include healing factors, antibiotics, or other healing agents, for example. In some variations, the drug-eluting agent is coated on a foldable member or a suture. In other variations, the therapeutic agent is impregnated within a foldable member or a suture and may be configured for latent release.
In some variations, one or more of the foldable members or the suture may comprise a radio-opaque material or radio-opaque markers. In this way, the distal anchor or suture can be viewed in vivo by using an X-ray, CT scanner, or similar imaging devices.
A proximal surface of each of the distal-most foldable member 1802, first inner foldable member 1804, and second inner foldable member 1806 is contoured to receive a distal surface of the first inner foldable member 1804, second inner foldable member 1806, and proximal-most foldable member 1808, respectively. The surface contours of each of the foldable members serve to relatively restrain the foldable members in the width dimension. Because the cross-sectional view shown in
Proximal-most foldable member 1808 may be generally described as having an inner region 1810 and an outer region 1812 on its distal surface. Inner region 1810 may be defined as a generally smooth surface, such as a surface with a constant radius of curvature. Outer region 1812 may be defined as beginning at a point at which the constant radius of curvature ends—such as the angular region 1818 identified in FIG. 18—and continuing until the peripheral edge of foldable member 1808. Outer region 1812 may be a distal protrusion 1814 and inner region 1810 may be a recess, such as depicted in
Distal protrusion 1814 of proximal-most foldable member 1808 restrains the second inner foldable member 1806 in the width dimension. Protrusion 1814 may be characterized by angular region 1816, angular region 1818, angular region 1820, and the length of the sides 1822 and 1824 connecting angular region 1816 to angular region 1820 and angular region 1820 to angular region 1818, respectively. Angular region 1816 may be characterized as the angle between a proximal surface of the proximal-most foldable member 1808 and the side 1822 of the proximal-most foldable member 1808. In some variations, this angle may be any angle between 0 and 90 degrees, including 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, and 90°, or any range between any two of the above angles. Angular region 1818 may be characterized as the angle between the side 1824 of the proximal-most foldable member 1808 and the surface of the inner region 1810 of the proximal-most foldable member 1808. In some variations, this angle may be any angle between 180 and 270 degrees, including 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, and 270°, or any range between any two of the above angles. In some further variations, angular region 1818 may include an angle greater than 270 degrees to provide a “snap-fit” with an opposing surface of an adjacent foldable member. Angular region 1820 may be characterized as the angle between the side 1822 of the proximal-most foldable member 1808 and the side 1824 of the proximal-most foldable member 1808. In some variations, this angle may be any angle between 0 and 180 degrees, including 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. Although angles 1816, 1818, and 1820 are depicted in
The relative widths of the inner regions and outer regions may be varied. In some variations, the width of the inner region is characterized as a percentage of the width of the outer region and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the width of the outer region is characterized as a percentage of the width of the inner region and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Proximal-most folding member 1808 is depicted as comprising an inner region which is relatively thin with respect to the total thickness of the distal anchor 1800 in the constrained configuration. In some variations, the thickness of the inner region is characterized as a percentage of the thickness of the distal anchor 1800 in the constrained configuration and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Proximal-most foldable member 1808 is illustrated as comprising a generally concave proximal surface with a constant radius of curvature. In other variations, the proximal surface of proximal-most foldable member 1808 has a non-constant radius of curvature. In yet other, variations the proximal surface of proximal-most foldable member 1808 comprises any of the surface geometries described herein. In some variations, the proximal surface of proximal-most foldable member 1808 is contoured to improve alignment with a non-planar surface of a body lumen.
In some variations, the cross-sectional profile of the foldable members illustrated in
The second inner foldable member 1806 may comprise a proximal surface that is contoured to align exactly with the contours of the distal surface of proximal-most foldable member 1808. In some variations, the surfaces do not align exactly and may be contoured only as is necessary to provide a predetermined limit on relative movement between the foldable members in the transverse direction. As depicted in
Additional inner foldable members may take similar structures and provide similar functions as those described above with respect to second inner foldable member 1806. For example, first inner foldable member 1804 may comprise a proximal surface configured to align exactly with the contours of the distal surface of second inner foldable member 1806, but other variations may not align the opposing surfaces exactly. Any angular features on second inner foldable member 1806 may take any of the angles described above with respect to proximal-most foldable member 1808. Similarly, any inner and outer regions of first inner foldable member 1804 may take any of the relative widths described above with respect to proximal-most foldable member 1808.
Similarly, the proximal surface of distal-most foldable member 1802 may take similar structures and provide similar functions as those described above with respect to the proximal-most foldable member 1808 and the inner foldable members 1804 and 1806. Any angular features on distal-most foldable member 1802 may take any of the angles described above with respect to the inner foldable member 1804 and 1806. Similarly, any inner and outer regions of distal-most foldable member 1802 may take any of the relative thickness described above with respect to proximal-most foldable member 1808.
Distal-most foldable member 1802 may be concave on its distal surface, as depicted in
First distal protrusion 1912 of proximal-most foldable member 1908 restrains the second inner foldable member 1906 in the width dimension. Protrusion 1914 may be characterized by angular region 1918, angular region 1920, angular region 1922, and the length of the sides 1924 and 1926 joining angular region 1918 to angular region 1920 and angular region 1920 to angular region 1922, respectively. Angular region 1918 may be characterized as the angle between the second inner region 1914 and the side 1924. In some variations, this angle may be any angle between 180 and 270 degrees, including 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, and 270°, or any range between any two of the above angles. In some further variations, angular region 1918 may include an angle greater than 270 degrees to provide a “snap-fit” with an opposing surface of an adjacent foldable member. Angular region 1920 may be characterized as the angle between the side 1924 and the side 1926. In some variations, this angle may be any angle between 0 and 180 degrees, including 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. Angular region 1922 may be characterized as the angle between the first inner region 1910 and the side 1926. In some variations, this angle may be any angle between 180 and 270 degrees, including 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, and 270°, or any range between any two of the above angles. In some further variations, angular region 1922 may include an angle greater than 270 degrees to provide a “snap-fit” with an opposing surface of an adjacent foldable member. Although angles 1918, 1920, and 1922 are depicted in
The relative widths of first inner region 1910, first distal protrusion 1912, second inner region 1914, and outer region 1916 may be varied. In some variations, the widths of first inner region 1910, first distal protrusion 1912, and second inner region 1914 may be characterized as percentages of the width of outer region 1916 and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the widths of first inner region 1910, first distal protrusion 1912, and outer region 1916 may be characterized as percentages of the width of second inner region 1914 and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the widths of first inner region 1910, second inner region 1914, and outer region 1916 may be characterized as percentages of the width of first distal protrusion 1912 and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the widths of first distal protrusion 1912, second inner region 1914, and outer region 1916 may be characterized as percentages of the width of first inner region 1910 and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Second inner foldable member 1906 may comprise a recess 1928 on its proximal surface corresponding to the first distal protrusion 1912 of proximal-most foldable member 1908. Recess 1928 may be defined by the length of the side surfaces and the angles created where the sides meet each other and where the sides meet the proximal surface of second inner foldable member. The lengths of the side surfaces may be characterized as a percentage of the diameter of the proximal-most foldable member 1908 and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. The angle may correspond to the angles of the distal protrusion 1912 on proximal-most foldable member 1908.
First inner foldable member 1904 may comprise a recess on its proximal surface corresponding to a distal protrusion on second foldable member 1906. The recess may be defined by the length of the side surfaces and the angles created where the sides meet each other and where the sides meet the proximal surface of second inner foldable member. The lengths of the side surfaces may be characterized as a percentage of the width of the proximal-most foldable member 1908 and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. The angle may correspond to the angles of the distal protrusion on second inner foldable member 1906.
Distal-most foldable member 1902 may share similar geometries and functions as distal-most foldable member 1802.
Although
In some variations, teeth configured to restrain movement may take the form of a series of peaks and troughs. In some variations, the peaks and troughs may be symmetrical. In other variations, the peaks and troughs may not be symmetrical. In some variations, the peaks and troughs may repeat at constant distances. In other variations, the peaks and troughs may be distributed unevenly throughout the surface of the foldable member. In some variations, the peaks and troughs are rounded. In others, some or all of the peaks and troughs have pointed edges. In some variations, an opposing surface of an adjacent foldable member may have a recess configured to receive the teeth. In other variations, the opposing surface of the adjacent foldable member does not include a recess for one or more of the teeth. In some variations, each surface of a foldable member that opposes a surface of an adjacent foldable member has teeth. In other variations, one or more of the foldable members of a distal anchor does not include teeth. In some variations, the teeth protrude the same distance from the surface of the foldable member. In other variations, one or more teeth protrude at a different distance from the surface of the foldable member. In some variations, the distance the teeth protrude from the surface of the foldable member may be characterized as a percentage of the thickness of the foldable member without the teeth and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the foldable member without the teeth may be characterized as a percentage of the distance the teeth protrude from the surface of the foldable member and may sometimes be about 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Distal-most foldable member 2502 comprises generally concave distal and proximal surfaces. As illustrated in
Inner foldable member 2504 comprises a proximal surface and a distal surface. As with distal-most foldable member 2502, the proximal surface may have a different curvature than the distal surface. The distal surface comprises an elevated region 2520 and a recessed region 2522. Elevated region 2520 may include a distal angular region 2514, a perimeter surface 2516, and a proximal angular region 2518. Distal angular region 2514, perimeter surface 2516, and proximal angular region 2518 may comprise any of the geometries discussed above with respect to distal angular region 2508, perimeter surface 2510, and proximal angular region 2512. Recessed region 2522 may be configured to mate inner foldable member 2504 with the proximal surface of distal-most foldable member 2502. Recessed region 2522 may comprise a distal angular region 2524, an interior surface 2526, and a proximal angular region 2528. Distal angular region 2524, interior surface 2526, and proximal angular region 2528 may be configured to mate recess 2522 of inner foldable member 2504 with distal-most foldable member 2502. Distal angular region 2524 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the diameter of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle may sometimes be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. In other variations, distal angular region 2524 may be a pointed corner created by the surface of elevation 2520 and the interior surface 2526. In some variations, the angle of the pointed corner may be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. In some variations, interior surface 2526 may comprise a length characterized as a percentage of the diameter of the inner foldable member, and may sometimes be 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, or any percentage range between any two of the above percentages. In some variations, proximal angular region 2528 may be a pointed corner created by the surface of recess 2522 and the interior surface 2526. In some variations, the angle of the pointed corner may be 0°, 10°, 20°, 30°, 60°, 90°, 120°, 150°, 180°, or any range between any two of the above angles.
Proximal-most foldable member 2506 comprises a proximal surface and a distal surface. The distal surface comprises a sloped region 2530 and a recessed region 2532. Recessed region 2532 may be configured to mate inner foldable member 2504 with the distal surface of proximal-most foldable member 2506. Recessed region 2532 may comprise a distal angular region 2534, an interior surface 2536, and a proximal angular region 2538. Distal angular region 2534 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the diameter of the proximal-most foldable member, and may sometimes be 55%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle may sometimes be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles. In other variations, distal angular region 2534 may be a pointed corner created by the surface of sloped region 2530 and the interior surface 2536. In some variations, the angle of the pointed corner may be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. In some variations, interior surface 2536 may comprise a length characterized as a percentage of the diameter of the inner foldable member, and may sometimes be 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, or any percentage range between any two of the above percentages. In some variations, proximal angular region 2538 may be a pointed corner created by the surface of recess 2532 and the interior surface 2536. In some variations, the angle of the pointed corner may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles.
The proximal surface of proximal-most foldable member 2506 may be configured to provide additional support. The proximal surface of proximal-most foldable member may include a recess 2544 and a proximal protrusion 2546. Both recess 2544 and proximal protrusion 2546 may be defined by an arc of a length and an angle. In some variations, the length of the arc is characterized as a percentage of the diameter of the inner foldable member, and may sometimes be 1%, 2%, 3%, 4%, 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle may sometimes be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles. Proximal protrusion 2546 may comprise an inner sealing region to preventingress of fistula material to the body lumen. Angular region 2542 may comprise an outer edge region of the proximal-most foldable member. In some variations, the outer edge region is oriented at an acute angle to the inner sealing region. In some embodiments, the position of the proximal protrusion may be characterized as a percentage of the diameter of the proximal-most foldable member and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Although distal anchor 2500 is illustrated with three foldable members, other variations may include four or more foldable members. Additional foldable members may comprise additional inner foldable members configured to mate to adjacent foldable members. In addition, although the foldable members are illustrated as having an overall curved form, in some variations the foldable members may have an overall planar form. Moreover, any of the overall shapes described herein may be employed. The distal-most and inner foldable members are depicted with a smooth proximal surface, but some variations may include topographical features configured to further restrain relative movement between the foldable members, such as those described herein. In addition, although a suture, a suture attachment structure, and apertures for threading a suture are not illustrated in
As depicted in
Distal-most foldable member 2602 comprises a generally planar proximal surface and a curved distal surface, with a side surface connecting the proximal and distal surfaces. The side surface of distal-most foldable member 2602 may be oriented at an acute angle to the height dimension, wherein the angle may sometimes be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. The thickness of distal-most foldable member 2602 may be characterized as a percentage of the overall thickness of the distal anchor 2600 in the deployed configuration, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. The diameter of distal-most foldable member 2602 may be characterized as a percentage of the diameter of proximal-most foldable member 2608, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
First inner foldable member 2604 may comprise a protruding outer region and a recess on its distal face. First inner foldable member 2604 may also comprise a recess on its proximal face, which may be aligned with an annular rib on second inner foldable member 2606. The protrusions and recess of first inner foldable member 2604 may comprise any of the protrusion and recess geometries described herein.
Second inner foldable member 2606 may comprise a protruding outer region, a first recess, an annular rib, and a second recess on its distal face. The relative size and positions of the first and second recesses may be determined by the positioning and size of the annular rib. Second inner foldable member 2606 may comprise a recess on its proximal face. The protrusions and recess of second inner foldable member 2606 may comprise any of the protrusion and recess geometries described herein.
Proximal-most foldable member 2608 may comprise a protruding outer region, a first recess, an annular rib, and a second recess on its distal face. The relative size and positions of the first and second recesses may be determined by the positioning and size of the annular rib. Proximal-most foldable member 2608 may comprise a smooth proximal face. The protrusions and recess of proximal-most foldable member 2608 may comprise any of the protrusion and recess geometries described herein.
Proximal-most foldable member comprises annular ribs 2710, 2712, 2714, 2718, and 2720. Annular ribs 2710, 2712, 2714, 2718, and 2720 may provide a separation between the proximal-most foldable member 2708 and the second inner foldable member 2706 while also providing a resistance to relative motion between the two adjacent foldable members. Although six annular ribs are shown in
Distal-most foldable member 2802 includes an outer region on its distal surface which may be tapered to improve mating. The outer region includes a distal angular region 2808, a planar surface 2810, and a proximal angular region 2812. Distal angular region 2808 may create an obtuse angle where the distal surface of distal-most foldable member 2802 and planar surface 2810 meet. In some variations, the angle may sometimes be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. Proximal angular region 2812 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the distal-most foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the distal-most foldable member is characterized as a percentage of the radius of proximal angular region 2812, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of proximal angular region 2812 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles. In some variations, the length of planar surface 2810 is characterized as a percentage of the thickness of the distal-most foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the distal-most foldable member is characterized as a percentage of the length of planar surface 2810, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Inner foldable member 2804 includes an outer region on its distal surface which comprises a protrusion and a recess. The recess comprises a distal angular region 2814, a first planar surface 2816, a proximal angular region 2824, and a second planar surface 2820. Distal angular region 2814 may create an obtuse angle where the distal surface of inner foldable member 2804 and first planar surface 2816 meet. In some variations, the angle may sometimes be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°. In some variations, the length of first planar surface 2816 is characterized as a percentage of the thickness of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the inner foldable member is characterized as a percentage of the length of first planar surface 2816, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. Proximal angular region 2824 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the inner foldable member is characterized as a percentage of the radius of proximal angular region 2824, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of proximal angular region 2824 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. In some variations, the length of second planar surface 2820 is characterized as a percentage of the thickness of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the inner foldable member is characterized as a percentage of the length of second planar surface 2820, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. The protrusion on the outer region of inner foldable member 2804 comprises a distal angular region 2818, a planar surface 2822, and a proximal angular region 2826. Distal angular region 2818 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the inner foldable member is characterized as a percentage of the radius of distal angular region 2818, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of distal angular region 2818 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles. In some variations, the length of planar surface 2822 is characterized as a percentage of the thickness of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the inner foldable member is characterized as a percentage of the length of planar surface 2822, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. Proximal angular region 2820 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the inner foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the inner foldable member is characterized as a percentage of the radius of proximal angular region 2820, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of proximal angular region 2820 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles.
Proximal-most foldable member 2806 includes an outer region on its distal surface which comprises a protrusion and a recess. The recess comprises a distal angular region 2830, a first planar surface 2832, a proximal angular region 2836, and a second planar surface 2834. Distal angular region 2830 may create an obtuse angle where the distal surface of proximal-most foldable member 2806 and first planar surface 2832 meet. In some variations, the angle may sometimes be 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°, or any range between any two of the above angles. In some variations, the length of first planar surface 2832 is characterized as a percentage of the thickness of the proximal-most foldable member, and may sometimes be 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%. In some variations, the thickness of the proximal-most foldable member is characterized as a percentage of the length of first planar surface 2832, and may sometimes be 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%. Proximal angular region 2836 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the proximal-most foldable member, and may sometimes be 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%. In some variations, the thickness of the proximal-most foldable member is characterized as a percentage of the radius of proximal angular region 2836, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of proximal angular region 2836 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°. In some variations, the length of second planar surface 2834 is characterized as a percentage of the thickness of the proximal-most foldable member, and may sometimes be 5%, 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%. In some variations, the thickness of the proximal-most foldable member is characterized as a percentage of the length of second planar surface 2834, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. The protrusion on the outer region of proximal-most foldable member 2806 comprises a distal angular region 2842, a planar surface 2840, and a proximal angular region 2838. Distal angular region 2842 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the proximal-most foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the proximal-most foldable member is characterized as a percentage of the radius of distal angular region 2842, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of distal angular region 2842 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles. In some variations, the length of planar surface 2840 is characterized as a percentage of the thickness of the proximal-most foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the proximal-most foldable member is characterized as a percentage of the length of planar surface 2840, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. Proximal angular region 2838 may be an arc with a radius and an angle. In some variations, the radius is characterized as a percentage of the thickness of the proximal-most foldable member, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the thickness of the proximal-most foldable member is characterized as a percentage of the radius of proximal angular region 2838, and may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In some variations, the angle of proximal angular region 2838 may be 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, or any range between any two of the above angles.
Protrusion 3110 is depicted as circular, but in some variations protrusion 3110 is non-circular. When circular, protrusion 3110 might be characterized as an arc with a radius that intersects the distal surface of an inner region of proximal-most foldable member 3104. In some variations, the radius of the arc is described as a percentage of the diameter of the proximal-most foldable member and may sometimes be 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, or any percentage range between any two of the above percentages. In some variations, the arc does not have a constant radius. In some variations, protrusion 3110 may be less resistant to movement than surrounding areas of the proximal-most foldable member 3104. In this way, protrusion 3110 may be configured to move relative to the surrounding area of proximal-most foldable member. In some variations, the reduction in resistance to deformation is facilitated by a decrease in the thickness of the proximal-most foldable member 3104 in the area of the protrusion 3110. In other areas, the density of the material is reduced in the area of the protrusion 3110. Although
Grapple 3114 is illustrated as being “fang” shaped, but in other embodiments grapple 3114 takes an alternative shape, such as a hook shape, that can puncture the surface of a body lumen. Grapple 3114 may comprise barbs oriented away from the direction of insertion, thereby preventing withdrawal of the fang after insertion. In some variations, the length of grapple 3114 is described as a percentage of the thickness of proximal-most foldable member 3104 from its distal-most point to its proximal-most point, and the percentage may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages. In other variations, the thickness of proximal-most foldable member 3104 from its distal-most point to its proximal-most point is described as a percentage of the length of grapple 3114, and the percentage may sometimes be 5%, 10%, 20%, 30%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 95%, or any percentage range between any two of the above percentages.
Although
The interior diameter of the elongate tubular member 3204 may be characterized as a percentage of the diameter of a proximal-most foldable member and may sometimes be 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, or any percentage range between any two of the above percentages. In some variations, profile reduction member 3204 is integrally connected to elongate tubular member 3202 and in other variations it is configured to removably couple to the tubular member. In some variations, the size and shape of a profile reduction section may be configured for a specific foldable member. For example, a distal-most foldable member may require a different profile reduction section than a larger proximal-most foldable member.
In some variations, the profile member 3204 includes inner grooves or ridges to guide the foldable members into the delivery tube and control the folding. The grooves or ridges may be configured to interact with surface features on the foldable members, such as the surface features described above that are configured for relatively restraining two adjacent foldable members.
Fistula tracts may be nonlinear or curvilinear and may contain cavities of varying sizes at different intervals within the tract. Fistulas may also comprise multiple interconnected or branching passages. A fistula treatment device disclosed herein may employ advantageous design, configuration techniques and attributes to accommodate such constraints and may be used, for example, in the treatment of anorectal fistulas. Some embodiments of fistula treatment devices may comprise irrigation and/or brushing devices which may be used, for example, to clean a fistula tract prior to, during, and/or after a procedure, and/or which may be used to clean a fistula tract prior to insertion of one or more implantable devices or other members (e.g., collagen plugs) therein.
Referring to
The apertures 3720 may be used to irrigate a fistula tract—in other words, one or more irrigation fluids may flow through, or be sprayed or otherwise dispersed via, the apertures 3720. In some embodiments, the distalmost aperture 20′ may be located at least about 2 centimeters (e.g., at least about 3 centimeters, at least about 4 centimeters, at least about 5 centimeters, at least about 10 centimeters, at least about 20 centimeters, at least about 30 centimeters, at least about 40 centimeters, at least about 50 centimeters, at least about 100 centimeters) from the distal end 3714 of the fistula irrigation catheter 3710. In other words, a fistula irrigation catheter may include apertures that are offset from the distal end of the catheter. This may be advantageous because it may, for example, provide for irrigation of a greater region of a fistula tract (e.g., both proximal and distal irrigation) than an irrigation catheter that only has an irrigation aperture at its distal end.
While the apertures 3720 are depicted as generally oval or elliptical in shape, apertures in a fistula irrigation catheter may have any suitable shape, and may all be of the same shape or may have different shapes from each other. In some embodiments, an aperture may be circular, triangular, or square. Other appropriate shapes may also be used. Moreover, the apertures may all have the same size or may have different sizes (e.g., to provide differing amounts of irrigation to different regions of a fistula tract).
In some embodiments, apertures may be radially positioned around a fistula irrigation device. For example,
In certain embodiments, apertures may be radially positioned around an irrigation catheter, and may be the distal termination points of radially oriented tubular members or lumens within the irrigation catheter. In some embodiments, a fistula irrigation device may comprise one or more infusion lumens that terminate at the location of one or more apertures in the device, such that the lumens do not extend any further distally, thereby avoiding creating “dead space” within the device. In certain embodiments, a fistula irrigation device may include one or more infusion lumens that extend distally beyond one or more apertures in the device; however, in some such embodiments, the infusion lumens may be plugged or otherwise filled distally of the apertures. In such cases, a guidewire lumen may be maintained open.
The tubular member 3716 of the fistula irrigation catheter 3710 may be relatively flexible in some embodiments and in certain embodiments, may include one or more relatively rigid regions. This may, for example, allow the tubular member 3716 to conform well to a tissue tract during use.
In certain embodiments, a fistula irrigation catheter may also have fistula brushing or debriding capabilities. As an example,
Of course, brushing members having different configurations may be used. For example,
It should be understood that while combination fistula irrigation and brushing or debriding devices have been described, in some cases a fistula treatment device may be configured to brush or debride a fistula tract without also irrigating the tract. Additionally, in some embodiments a fistula brushing device may not be in the form of a catheter. As an example,
Any appropriate methods may be used to deliver or deploy the fistula treatment devices described herein. For example,
Once the tubular member 3716 with the apertures 3720 is located within the fistula tract, the fistula irrigation catheter 3710 may be grasped at both its proximal and distal ends 3712 and 3714, and moved back and forth within the tract 4000 (e.g., as illustrated by arrow 4008), to effectively “floss” the tract 4000 and thereby irrigate different regions of the tract 4000. This may, for example, provide for good cleaning and minimal contamination of the fistula tract 4000 (e.g., by providing for both proximal and distal irrigation of the fistula tract). Moreover, and as discussed above, the apertures 3720 may be oriented to spray irrigation fluid (e.g., saline) in a non-orthogonal direction—for example, some of the apertures 3720 may be forward-angled and some of the apertures 3720 may be backward-angled, so that bidirectional irrigation may be provided. Additionally, it should be noted that, while not shown here, fistula brushing members or devices may also be moved back and forth within a fistula tract in the manner described above.
To perform the procedures described above, a kit may be provided that contains, for example, one or more fistula irrigation devices, one or more fistula brushing devices, and/or one or more combination fistula irrigation and brushing devices. The kit may also contain one or more other items, including but not limited to a guidewire (e.g., a 0.038″ guidewire), a peel-away sheath (e.g., a 7F, 8F, 9F, 10F, or 12F sheath), one or more syringes (e.g., 0.5 cc, 1 cc, 5 cc, and/or 10 cc syringes), saline or biocompatible fluid, contrast media, a scalpel, one or more free needles, and non-resorbable sutures (e.g. 3-0 or 4-0 nylon suture). A fistula tract dilator may also be provided in the kit. The contents of a kit may be provided in sterile packages. Instructions may be provided on or with the kit, or alternatively via the Internet or another indirect method, and may provide direction on how to employ the kit (e.g., outlining a deployment method such as one of those described herein). While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that those examples are brought by way of example only. Numerous changes, variations, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that the methods and structures within the scope of these claims will be covered thereby.
This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Ser. No. 61/497,899, filed Jun. 16, 2011, and U.S. Provisional Ser. No. 61/498,495, filed Jun. 17, 2011, which are hereby incorporated by reference in their entireties.
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