IMPLANTABLE URINARY CONTINENCE DEVICE WITH HELICAL ANCHOR

An implantable device includes a conduit, an adjustable membrane element coupled to the conduit near the front end of the conduit for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence, and a helix coupled to the front end of the conduit. The helix functions as a fixation mechanism to anchor the implantable device to the tissue. The implantable device can be inserted into tissue using a sheath and can be rotated with the sheath by partially inflating the adjustable membrane element placed in a front end portion of the sheath, and the helix can be turned into the tissue by rotating the sheath.

TECHNICAL FIELD

This document relates generally to implantable medical devices and more particularly to a device with a helix for anchoring a device for treating urinary incontinence to tissue after its implantation in a patient.

BACKGROUND

An example of an implantable device for treating urinary incontinence includes an adjustable membrane element, such as a balloon, connected to a rear port with a conduit. The implantable device can be implanted in a patient with the adjustable membrane element placed adjacent to the patient's urethra and the rear port placed underneath the patient's skin by minimally invasive surgery. The adjustable membrane element can be adjusted during and after the surgery by injecting fluid into the rear port or extracting fluid from the rear port percutaneously using a needle. In an exemplary treatment, two of such implantable devices are placed in the patient such that the two adjustable membrane elements provide pressure and support at the patient's bladder neck to protect against accidental leaking of urine in cases such as stress urinary incontinence (e.g., leaking during sneeze, cough, or physical activity). The efficacy of this treatment depends on accurate placement of the adjustable membrane element at a target site in the patient, adjustment of the adjustable membrane element after the placement, and maintaining the position of the adjustable membrane element over time.

SUMMARY

An implantable device includes a conduit, an adjustable membrane element coupled to the conduit near the front end of the conduit for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence, and a helix coupled to the front end of the conduit. The helix functions as a fixation mechanism to anchor the implantable device to the tissue. The implantable device can be inserted into tissue using a sheath and can be rotated with the sheath by partially inflating the adjustable membrane element placed in a front end portion of the sheath, and the helix can be turned into the tissue by rotating the sheath.

DETAILED DESCRIPTION

This document discusses, among other things, a mechanism and tool for fixation of an implantable device to surrounding tissue for treating urinary incontinence. The implantable device can include, for example, an adjustable membrane element connected to a rear port with a conduit that has a lumen providing for fluid communication between a chamber of the adjustable membrane element and an interior cavity of the rear port. Various structural elements of the implantable device (e.g., an implantable device110shown inFIG.1) discussed in this document may each be referred to by various terms. The “adjustable membrane element” (e.g., the adjustable membrane element112shown inFIG.1) can also be referred to as, for example, an adjustable element, an expandable element, an expandable membrane element, a forward expandable membrane element, a balloon, or an adjustable balloon. The “conduit” the conduit114shown inFIG.1) can also be referred to as, for example, a central conduit element, a device conduit, a connecting conduit, a connecting conduit tube, or a tubular elongate body. The “rear port” (e.g., the rear port116shown inFIG.1) can also be referred to as, for example, a rearward port portion or a rear port element. The “lumen” (e.g., the first lumen115and the second lumen117shown inFIG.2) can also be referred to as, for example, a passageway, an inner passageway, or an interior passageway.

In an example, the implantable device includes an adjustable balloon connected to a port with a conduit. The balloon is placed adjacent the urethra to exert non-circumferential compression upon the urethral wall. The effectiveness of the therapy depends on proper positioning of the balloon at a target site in a patient's body, such as in the retropubic space near the urethra-vesical junction above the urogenital diaphragm in close proximity to the urethral walls. When two balloons (e.g., of two implantable devices) are used, their preferred positioning is usually symmetrical and lateral with respect to the urethra. Medical imaging techniques such as fluoroscopy or transrectal ultrasonography (TRUS) can be used to aid the positioning of the balloon(s). Sensors incorporated into the implantable device(s) and/or one or more surgical tools can also be used to aid the positioning of the balloon(s), such as discussed in U.S. patent application Ser. No. 16/450,246, filed on Jun. 24, 2019, assigned to UroMedica, Inc., which is incorporated by reference herein in its entirety.

During the implantation procedure, the implantable device(s) is(are) placed in the patient with the balloon(s) positioned and fixed in place at the target site(s). The balloon(s) is(are) only slightly inflated, typically between 0.5 and 1.5 cc, for a period of 4 to 6 weeks to allow tissue encapsulation in order to stabilize the balloon(s) at its(their) target site(s). In particular, without encapsulation the implantable device(s) is(are) prone to migrate down the dilation path through which the implantable device(s) was(were) implanted. For optimal effect it is important that the balloon(s) be maintained above the pelvic floor. Thus, it is very important that fixation occur during this implantation procedure. After the encapsulation, the patient will go through one or more adjustment procedures during which the volume of fluid in the balloon(s) is adjusted to obtain and maintain urinary continence without causing undesirable obstruction.

The present subject matter provides an implantable device for treating urinary incontinence that has a helical fixation mechanism for preventing a balloon of the implantable device from unwanted displacement.FIGS.1-9illustrate various embodiments of an implantable device into which the helical fixation mechanism can be incorporated and surgical tools used for placing the implantable device into a patient. The various embodiments of the implantable device and the surgical tools are illustrated inFIGS.1-9and discussed below by way of example, and not by way of restriction. These examples as well as additional examples of the implantable device and the surgical tool are discussed in U.S. Pat. Nos. 5,964,806, 6,045,498, 6,419,624, 6,579,224, 8,926,494, and 9,861,384, all assigned to UroMedica, Inc., which are incorporated by reference herein in their entireties.FIGS.10-12illustrate an example of placement and adjustment of a pair of the implantable devices for urethral coaptation in a post-prostatectomy patient.FIGS.13-19illustrate the helical fixation mechanism incorporated onto the implantable device and a process for placing the implantable device into tissue of a patient and anchoring the implantable medical device to the tissue.

FIG.1is a perspective view of an implantable device110and a syringe120, according to an embodiment of the present subject matter.FIG.2is a longitudinal cross-sectional view of the implantable device110FIG.3is a cross-sectional view of the implantable device110taken along line3-3ofFIG.2. The implantable device110includes an adjustable membrane element (also referred to as a balloon)112, shown in its expanded state inFIG.1, which is attached pressure-tightly to an elongate conduit114. The conduit114has a front end160. In one embodiment, the peripheral surface of the conduit114is connected to and sealed to the adjustable membrane element112. In one embodiment, the adjustable membrane element112includes a continuous wall having an inner surface defining a chamber.

The conduit114includes a first lumen115and a second lumen117(as shown inFIGS.2and3). In one embodiment, the first lumen115extends longitudinally in the conduit114from a first opening115A. to one or more second openings115B (e.g., two openings as shown inFIG.2). The second opening(s)115B is(are) in fluid communication with the chamber of adjustable membrane element112for adjustably expanding or contracting the adjustable membrane element112by flowable material introduced through the first opening115A. To prevent leakage of the fluid from the adjustable membrane element112, the first lumen115has a closed end at or near the front end160of the conduit114. The closed end can be formed by sealing the front end of the first lumen115, for example, using silicone adhesive. Alternatively, the first lumen115can be closed by manufacturing it to end before reaching the front end of the conduit1014.

The second lumen117extends longitudinally along the conduit114from an inlet117A to a closed end117B at the front end160. In one embodiment, the second lumen117and the inlet117A are each of sufficient diameter to receive a push wire (also referred to as a push rod) that can be used to advance the implantable device110in the tissue.

The implantable device110further includes a rear port116, which is coupled to the rear end of the conduit114. In one embodiment, this includes a cavity116A and an elastic septum118. The cavity116A is coupled to and in fluid communication with the first lumen115at the first opening115A. The elastic septum118allows for access to the cavity116A using a needle (such as the needle121shown inFIG.1) for introducing and/or withdrawing fluid to expand (inflate) and/or contract (deflate) the adjustable membrane element112. The diameter of the elastic septum118can be slightly larger than the diameter of the cavity116A to produce compression to the elastic septum1018for better sealing. A syringe120including a hollow needle121and a rear axially-movable plunger122is provided for injecting a suitable flowable material into or drawing the suitable flowable material from the implantable device110through the rear port116to expand or contract, respectively, the adjustable membrane element112. In various embodiments, the flowable material can be, for example, normal saline, polymer gels such as silicone gels or hydrogels of polyvinylpyrrolidone, polyethylene glycol, or carboxy methyl cellulose, or high viscosity liquids such as hyaluronic acid, dextran, polyacrylic acid, or polyvinyl alcohol. When desired, the flowable material can be made radiopaque (such as isotonic contrast media) so that the degree of membrane inflation can be viewed by x-ray or be echogenic so that it can be viewed by ultrasound.

In one embodiment, as illustrated inFIG.2, the rear port116includes a titanium port liner111and an overmold113. The port liner111surrounds the cavity116A and a portion of the septum118to prevent the needle121from piercing through the rear port116from the inside or in case needle121has been misdirected from the outside. The inner diameter of the port liner111can be slightly smaller than the enclosed portion of the septum118to provide compression for better sealing. As shown inFIG.2, the port liner111includes a cylindrical portion that surrounds the cavity116A and a cap connected to the cylindrical portion. The cap has a hole that allows for the fluid communication between the cavity116A and the first lumen. The hole can have a smaller diameter than that of the needle to prevent the needle from forward penetration beyond the cavity116A, The overmold113can be made of a silicone or biostable segmented polyurethane elastomer and molded over the port liner111and a real portion of the conduit114to connect the rear port116to the conduit114. The overmold113includes a tapered portion that functions as a strain relief, which protects the conduit114including the connection between the conduit114and the rear port116from, for example, damage that may result from cyclic bending due to body movements while the implantable device110is implanted in the patient or breakage that may result from puling during removal of the implantable device110from tissue.

The entire implantable device110, including the adjustable membrane element112is formed of biocompatible materials including, for example, a silicone or polyurethane-based elastomer and metals such as titanium or tantalum, suitable for long-term implant. Optionally, the conduit114and the rear port116can be formed as a unitary construction. Optionally, the implantable device110includes one or more elastic portions each constructed of biostable segmented polyurethane, which is polyurethane with flexible segments of macrodiols chosen for biostability. This biostability is the ability of a polymer to resist degradation such as by stress cracking in the body over time expected of a long-term implant. Macrodiols of silaxane, polyether, and polycarbonate are known to impart biostability to segmented polyurethanes and can be used in any combination to impart properties such as toughness, resistance to cuts, wear and lack of permeability superior to silicone. In addition, being thermoplastic, the macrodiols allow for blow molding the adjustable membrane element112at a significant reduction in cost and possibly use of additive manufacturing such as 3D printing. The adjustable membrane element112can be adhered to the conduit114using a suitable adhesive or by means such as sonic welding or solvent bonding. An example of a silicone-based material includes polydimethylsiloxane (PDMS), having various formulation depending on the intended application, such as for injection molding, extrusion, in a dispersion for dip molding on a mandril, or as an adhesive.

FIG.4shows the implanted device110after being placed at a desired location in a patient and expanded to displace body tissue toward a body lumen432for causing adjustable restriction of the body lumen432, according to an embodiment of the present subject matter. After the implantable device110has been placed in the patient (e.g., using a method with surgical tools as discussed below with reference toFIGS.7-10) such that the adjustable membrane element112in its contracted state is in the desired position adjacent to the body lumen432, the body lumen432can be restricted to a desired degree by piercing septum118with the needle121of the syringe120and injecting the flowable material through the first lumen115into the adjustable membrane element112. The physician can determine the desired degree of restriction of the body lumen432by means such as infusing fluid through the body lumen432past the restriction and measuring the back pressure. In one embodiment, the body lumen is the urethra, as further discussed below with reference toFIGS.10-12.

After the implantable device110has been properly positioned with the adjustable membrane element112located near the body lumen432and the septum118in the rear port116located near the skin430, the device is injected with the flowable material from the syringe120. The adjustable membrane element112can be inflated to a certain extent and then deflated to an extent suitable for encapsulation of the adjustable membrane element112by body tissue.

The present subject matter provides the implantable device110with adjustability of the membrane expansion post-operatively. This adjustability is effected because the septum118is located remote from the adjustable membrane element112but near and under the patient's skin, for example in the scrotum of a male patient or labia of a female patient. The rear port116and septum118are located by, for instance, manual palpation of the skin region and the needle121of the syringe120is inserted through the skin and the septum118to add or remove the Plowable material from the adjustable membrane element112, thus increasing or decreasing the restriction of the body lumen432.

FIG.5is a longitudinal cross-sectional view of an implantable device510, according to an embodiment of the present subject matter.FIG.6is a cross-sectional view of the implantable device510taken along line6-6ofFIG.5. The implantable device510includes an adjustable membrane element (also referred to as a balloon)512and an elongate conduit514, where the conduit514includes at least a first lumen515which extends longitudinally in the conduit514from a first opening515A at a rear end (also referred to as a proximal end) of the conduit to a second opening515B.

The implantable device510further includes a rear port516, where the rear port516is coupled to the rear end of the conduit514. In one embodiment, the rear port516is coupled to the rear end of the elongate body514using chemical adhesives, or alternately, depending on the materials, using sonic welding, solvent bonding and/or other techniques as are known in the art. In an additional embodiment, the rear port516and the conduit514are formed together in a polymer molding process, such as liquid injection molding or overmolding.

The rear port516includes a cavity516A, where the cavity516A is in fluid communication with the first opening515A of the conduit514. In one embodiment, the rear port516also includes an elastic septum518through which the cavity516A is accessed, where the elastic septum518is self-sealing after repeated pierces, for example, with a needle. In one embodiment, the elastic septum518is retained in the rear port516by a clamp ring519located around the rear port516. In one embodiment, the clamp ring519is made of a biocompatible material, such as, for example, titanium. In one embodiment, the elastic septum518is made of a biocompatible material, such as, for example, silicone or biostable segmented polyurethane. The rear port516has an outer diameter defined by an outer surface554of the rear port516. In one embodiment, the rear port516has an outer diameter between 2 and 15 millimeters, with 5.7 millimeters being a specific example.

Once the implantable device510is positioned within a body, the adjustable membrane element512is inflated by releasably connecting a flowable material source to the rear port516. In one embodiment, the flowable material source includes a syringe with a non-coring needle, such as the syringe120with the needle121, where the needle is inserted through the elastic septum518. A measured supply of fluid volume can be introduced into the implantable device510, and the adjustable membrane element112expands or contracts due to a volume of the flowable material introduced into the cavity516A of the rear port516from the flowable material source. The adjustable membrane element512is then used to at least partially and adjustably restrict the body lumen. Once the adjustable membrane element512has been inflated, the needle is withdrawn from the septum518of the rear port516.

in an additional embodiment, a detectable marker570is imbedded in the implantable device510. For example, the detectable marker570is located at the front end (also referred to as a distal end)560of the conduit514. In one embodiment the detectable marker570is located in a lumen of the conduit514. The detectable marker570allows the front end560, and thus the front end of the adjustable membrane element512, to be located within the tissue of a patient using any number of visualization techniques which employ electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker570is constructed and located to allow for visualization and orientation of the adjustable membrane element512in the tissue of the patient. In one embodiment, the detectable marker570is constructed of radiopaque tantalum and can be visualized with X-ray. In one embodiment, the entire conduit514is made radiopaque by, for example, dispersing tantalum powder in the conduit514. The implantable device510can formed of biocompatible materials in the same or substantially similar manner as discussed above for the implantable medical device110. Likewise, a detectable marker can be placed in substantially the same way, and serve substantially the same purposes, as discussed above for the implantable medical device110.

FIGS.7-9illustrate a surgical tool kit for placement of an implantable device, such as the implantable device110and510, in tissue of the patient. The surgical tool kit includes a sheath746(shown inFIG.7) and a trocar838(shown inFIG.8).FIG.9shows an assembly940including the sheath746and the trocar838.

The trocar838includes an elongate member (shaft)837and a handle portion836. In one embodiment, the trocar838is disposable (i.e., not intended for reuse or not suitable for reuse, e.g., not suitable for cleansing and re-sterilization after use). In another embodiment, the trocar838is reusable (i.e., can be cleansed and re-sterilized after each use). The elongate member837, in various embodiments, is sterilizable. In additional embodiments, the handle portion836is also sterilizable. In another embodiment, the trocar838includes steam sterilizable components. Various embodiments incorporate materials known to provide for such function, such as surgical grade stainless steel. Multiple embodiments are contemplated by the present subject matter. In each embodiment, one or more materials are used in constructing the elongate member837. In each embodiment, one or more materials are used in constructing handle portion836.

The trocar838has a proximal end and a distal end, with the handle portion located at the proximal end. In one embodiment, the trocar838has a sharp tip at the distal end. In another embodiment, the trocar838has a blunt tip at the distal end. In one embodiment, the trocar838having the sharp tip and the trocar838having the blunt tip are both provided for implanting the device such as implantable device110and510.

The sheath746includes an elongate member (shaft)745and a handle portion743. In one embodiment, the sheath746is disposable (i.e., not intended for reuse or not suitable for reuse, e.g., not suitable for cleansing and re-sterilization after use). This may provide for cost effectiveness when the sheath746is subjected to damage during use (e.g., to be modified to facilitate its separation from the implantable device during an implantation procedure). In another embodiment, the sheath746is reusable (e.g., can be cleansed and re-sterilized after each use). The elongate member745is trough (U- or C-) shaped across its diameter, in one embodiment. In various embodiments, the elongate member745includes tubing which has a slot opening running at least part of the way down its length. The elongate member745has a cross section which is curved in various embodiments. As such, these embodiments define a channel744of the sheath746. In various embodiments, a removable trocar is sized for slidable disposition in the elongate member of the sheath746, via an opening in the handle portion743. In various embodiments, one or more materials are used in constructing the elongate member745. In each embodiment, one or more materials are used in constructing handle portion743. Examples of such one or more materials include stainless steel and various suitable polymers.

The trocar838is inserted into the sheath746to form the assembly940, as shown inFIG.9. In one embodiment, the trocar838having the sharp tip is used for penetrating tissue of the patient, such as when the physician grasps the handle836and maneuvers the trocar838, distal portion first, through an incision, any scar tissue that may be present, the facia of the pelvic floor and toward an implant site located proximal to the bladder neck or prostate (if present) of the patient. In various embodiments, the physician is to insert the assembly940with the trocar838into an incision made on the patient and to advance the assembly940in tissue of the patient until the trocar838reaches the bladder neck, and the tip of the sheath746is withdrawn (e.g., about 1 to 2 cm) to allow the adjustable membrane element112to be partially inflated (e.g., to about 1 cc) at the bladder neck while maintaining position of the tip of the sheath746at the target site. In one embodiment, the trocar838having the sharp tip is used until the sharp tip reaches the pelvic floor of the patient, and then it is replaced by the trocar838having the blunt tip to avoid bladder perforation when approaching the bladder neck of the patient.

In various embodiments, a surgical tool kit including the trocar838and the sheath746is provided to the physician performing implantation of the device such as implantable device110and510. In one embodiment, the surgical tool kit includes the trocar838having the sharp tip, the trocar838having the blunt tip, and the sheath746. In one embodiment, the surgical tool kit, including the trocar(s)838(sharp tip and/or blunt tip) and the sheath746is disposable, i.e., intended for single-use. Compared to reusable trocar and sheath, the disposable trocar and sheath can be more cost effective and/or safer (e.g., due to the cost and effectiveness concerns associated with the cleansing and re-sterilization).

FIG.10is an illustration, including a broken-out view, showing introduction of an implantable device1010into tissue of a male post-prostatectomy patient using the assembly940, to provide for coaptation of a urethra, according to an embodiment of present subject matter. Examples of the implantable device1010include implantable devices110,510,1310,1410,1510, and any of their embodiments as discussed in this document. In various embodiments, the physician is to insert the assembly940into an incision made in the perineum below the scrotum of the patient and to advance the assembly940in tissue of the patient until the tip of the trocar838reaches a target site proximal to the bladder neck of the bladder. Then, the trocar838is removed while maintaining position of the tip of the sheath746at the target site. The implantable device1010is advanced with the adjustable membrane element deflated through the sheath746to a selected position using a push wire. In one embodiment, it is helpful to ensure the push wire is fully inserted in the adjustable continence device. In one embodiment, the position of the front end of the implantable device1010can be confirmed by, for example, fluoroscopy, cystoscopy or palpation. In one embodiment, the tip of the implantable device1010is positioned adjacent the bladder neck.

In one embodiment, the sheath is pulled back about 2 centimeters such that the adjustable membrane element of the implantable device1010is clear of the sheath746. This is to, in part, ensure that the balloon is not damaged during inflation. The implantable device1010can then be adjusted by penetrating the septum of the rear port of the implantable device1010with a needle of a syringe, such as a 23 gauge non-coring needle on the syringe, and the adjustable membrane element can be partially inflated with fluid, such as with approximately 1 milliliter of normal saline or isotonic contrast solution. In embodiments using x-ray visualization or ultrasound, the physician can view the adjustable membrane element assuming a spherical shape. In one embodiment, the sheath746is completely removed from the patient before the adjustable membrane element is inflated.

In one embodiment, after the adjustable membrane element of the implantable device1010is partially inflated and the sheath746is completely removed from the patient, a path is tunneled into the scrotum, and the rear port of the implantable device1010is grasped with a forceps and placed toward the top end of the scrotum. The incision can be closed, such as by suturing, over the conduit of the implantable device1010.

FIG.11is an illustration, including a broken-out view, showing a pair of implantable devices1010A and1010B placed in the patient to provide for coaptation of the urethra, according to an embodiment of present subject matter. In various embodiments, the implantable devices1010A and1010B are each an instance of the implantable device1010. The physician can apply the same procedure as discussed above to place each of the implantable devices1010A and1010B, with the two devices positioned contralaterally to each other with respect to the urethra of the patient.

In one embodiment, when it is possible, the physician is to confirm symmetrical positioning of the adjustable membrane elements of the implantable devices1010A and1010B with respect to the urethra such as by using x-ray visualization or ultrasound. The push wires can be removed from the implantable devices1010A and1010B after the positioning of both devices is determined to be adequate by the physician.

FIG.12is an illustration, including a broken-out view, showing adjustment of the coaptation of the urethra after the pair of the implantable devices1010A and1010B are placed in the patient, according to an embodiment of present subject matter. After their placement in the patient, the volume in the adjustable membrane elements of the implantable devices1010A and1010B can each be adjusted percutaneously by penetrating the skin and the septum of the rear port of each of the implantable devices1010A and1010B with the needle of the syringe120. After placement at the target sites, the adjustable membrane elements are each inflated to a volume of 0.5 to 1.5 cc to observe, with x-ray or ultrasound, that they are in the correct positions to coapt the urethra. Once this is confirmed, the adjustable membrane elements are left at a volume of 0.5 to 1.5 cc each such that they remain firmly in position but not distorted, for example, by scar tissue or anatomical abnormalities. The adjustable membrane elements are left in this state for 4 to 6 weeks so that tissue encapsulation fixes their positions. Subsequently, the volume of each adjustable membrane element is adjusted upward in 0.5 to 1.0 cc every 4 to 6 weeks until continence is achieved. Over time further adjustments may be needed to increase the volume of each of the adjustable membrane elements in order to maintain continence or to decrease that volume to prevent urinary retention. In some examples, the physician optionally confirms absence of urethral or bladder injury by cystoscopic examination.

While coaptation of the urethra in a male post-prostatectomy patient is illustrated inFIGS.10-12as an example, the present subject matter can be applied for coaptation of the urethra of any patient for urinary continence, in various embodiments (e.g., in a female patient, or in a male patient after transurethral resection of the prostrate (TURP)). In various other embodiments, the present subject matter can be applied for coaptation of any body lumen when desired and feasible considering factors including anatomy.

FIG.13is an illustration of an implantable device kit1320, including an implantable device1310, a sheath1346, and optionally a push wire1324, according to an embodiment of present subject matter. The implantable device1310, the sheath1346, and optionally the push wire1324can be provided as a device kit1320, which can also include other accessories (e.g., surgical tools for inserting the sheath1346into tissue, such as one or more trocars for use with the sheath, as discussed with reference toFIGS.7-9above). The implantable device1310can be used to coapt a lumen in a body, and can include an adjustable membrane element (also referred to as a balloon)1312, an elongate conduit1314, a rear port1316, and a helix1350. The adjustable membrane element1312is configured to coapt the lumen and includes a continuous wall having an inner surface defining a chamber. The rear port1316includes a conical strain relief1325made of a silicone-based or segmented polyurethane-based elastomer coupled to a port base1323. The conduit1314has a conduit rear end1314A coupled to the rear port1316within the strain relief1325, a conduit front end1314B coupled to the adjustable membrane element1312, a peripheral surface connected to and sealed to the adjustable membrane element1312near the conduit front end1314B, and optionally (when the push wire1324is used, as discussed below) a push wire lumen1317extending longitudinally in the conduit1314from a lumen inlet1317A near the conduit rear end1314A to a lumen front end1317B at the conduit front end1314B. The lumen inlet1317A has a size allowing a portion of the push wire1324to enter. The push wire lumen1317has a diameter to accommodate at least the portion of the push wire1324that enters through the lumen inlet1317A. The diameter is suitable for the push wire1324to move longitudinally in the push wire lumen1317by pushing a portion of the push wire1324that is outside of the conduit1314.

The rear port1316is coupled to the conduit1314with the conduit rear end1314A in the strain relief1325. The port base1323includes a cavity (not shown inFIG.13) in fluid communication with the chamber of the adjustable membrane element1312through an inflation lumen (not shown inFIG.13) in the conduit1314to allow for expansion of the adjustable membrane element1312by injecting a fluid into the chamber and contraction of the adjustable membrane element1312by withdrawing the fluid from the chamber. In some embodiments, the rear port1316is releasably coupled to the conduit rear end1314A. In various embodiments, the exterior surface of the port base1323is covered by a layer made from the same material as the strain relief. This can be done by extending the strain relief1325to cover a substantial portion of the port base1323or the entire port base1323.

In one embodiment, the rear port1316is substantially identical to the rear port116as discussed above with reference toFIG.2. The strain relief1325is formed by the tapered portion of the overmold113. The port base1323is formed by the remaining portion of the overmold113(surrounding the port liner111), the port liner111, the elastic septum118, and the cavity116A. In other words, the strain relief1325includes the tapered portion of the overmold113of the rear port116as shown inFIG.2, and the port base1323includes the rest of the rear port116as shown inFIG.2.

In various embodiments, the implantable device1310is a multi-lumen (e.g., dual lumen) implantable device including the push wire lumen1317and the inflation lumen (not shown inFIG.13) as separate lumens,

The helix1350is coupled to the conduit front end1314B to function as a fixation mechanism that limits displacement of the implantable device1310in the tissue after implantation by anchoring the implantable device1310to the tissue. In various embodiments, the implantable device1310can be anchored to the tissue by turning the helix1350into a portion of the tissue using a rotational movement of the implantable device1310in a tightening direction (e.g., a clockwise direction). In some embodiments, the implantable device1310can be released from the tissue by disengaging the helix1350from the portion of the tissue using a rotational movement of the implantable device1310in a loosening direction (e.g., a counterclockwise direction) when, for example, the implantable device1310needs to be repositioned in the tissue or removed from the tissue. This may be done, for example, by introducing the push wire1324to rotate the implantable device1310or to aid such rotation. In various embodiments, the implantable device1310can also be released from the tissue by disengaging the helix1350from the portion of the tissue by pulling the implantable device1310(a method referred to as a “pull-out release”), with the helix1350being configured to avoid unacceptable level of tissue damage and/or device breakage resulting from the pulling. For example, the amount of pulling force required for pulling the implantable device1310from the tissue at the target site while the helix1350remains engaged with the tissue (referred to as the “pull-out force”) is to be small enough to prevent the implantable device1310from being broken and a portion left inside the patient. In one embodiment, the helix1350is made of a bioresorbable material to facilitate the pull-out release. After being placed in body tissue, a bioresorbable material (also referred to as biodegradable material) degrades over time into one or more non-toxic substances that can be safely absorbed by the patient's body. The bioresorbable helix1350can anchor the implantable device1310until it is stabilized by the tissue encapsulation that follows the initial placement. Examples of bioresorbable materials for the helix1350include bioresorbable polymers that have mechanical properties (e.g., strength and stiffness) suitable to be used to construct the helix, such as chitosan (e.g., derived from naturally occurring chitin, such as from shellfish or mushrooms), and bioresorbable metals such as alloys of manganese, magnesium, iron, and/or zinc.

The implantable device1310can be a combination of the helix1350with a suitable implantable device selected from those discussed with reference toFIGS.1-12, including but not limited to the implantable device110or an implantable device including various combinations of features of the implantable devices110,510, and1010.

The sheath1346has an elongate cylindrical sheath body1345and a channel1344extending longitudinally within the sheath body1345. The sheath body1345A has a sheath rear end1345A, a sheath front end1345B, and a slot1348B-C extending longitudinally along at least a portion of sheath body1345. In the illustrated embodiment, the slot1348B-C includes a slot front portion1348B and a slot middle portion1348C. In other embodiments, the slot middle portion1348C can extend to the sheath rear end1345A or a point near the sheath rear end1345A. The slot middle portion1348C is sized to allow at least the adjustable membrane element1312(in its deflated state) and the conduit1314to be placed in the channel1344of the sheath1346. The slot front portion13488is sized to prevent adjustable membrane element1312from exiting the channel1344when being advanced within the channel1344and to allow the sheath1346to be separated from the implantable device1310(e.g., by passing a portion of the elongate conduit1314, which can be stretched to reduce its diameter if necessary, through the slot front portion1348B) and then removed from the tissue after the implantable device1310is placed in and anchored to the tissue. This is to reduce the possibility of an edge of the slot front portion1348B cutting into the inflation lumen in the conduit1314. Another way (other than stretching the elongate conduit1314) to protect the inflation lumen in the conduit1314from being cut by an edge of the slot front portion1348B is to align the lumen inlet1317A with the middle of the slot front portion1348B when passing the portion of the elongate conduit1314through the slot front portion1348B). Yet another way to protect the inflation lumen in the conduit1314from being cut by an edge of the slot front portion1348B is to pass a portion of the strain relief through the slot front portion1348B, as further discussed below with reference toFIG.19. In various embodiments, the sheath1346can be a sheath946that is C-shaped across the diameter and modified to include the slot1348having a varying width, which includes a front portion and a middle portion that is wider than the front portion.

In one embodiment, the outer surface of the rear port1316and the adjustable membrane element1312are of a size (e.g., a diameter) that is smaller than an inner size (e.g., a diameter) of the channel1344to allow the implantable device1310to be moved longitudinally through the channel1344of the sheath1346. In an alternative embodiment, the rear port1316is constructed of at least one material flexible enough to allow the size of the rear port1316in its relaxed state to be compressed to a size sufficiently small so that the implantable device1310can be moved longitudinally through the channel1344. In one embodiment, the conduit1314has a stiffness sufficient to allow force applied at the conduit rear end1314A (e.g., through the rear port1316) to move the implantable device1310at least partially through the channel1344. In this embodiment, the push wire1324is optional, and the implantable device kit1320may only include the implantable device1310and the sheath1346. In one embodiment, the stiffness of the conduit1314is determined based on the type of material used in constructing its tubular elongate body. For example, the conduit1314can be made of polyurethane or silicone. The conduit1314made of polyurethane would be substantially stiffer than the conduit1314made of silicone. Alternatively, support elements can be added to the tubular elongate body of the conduit1314. For example, a metal coil can be placed longitudinally within the tubular elongate body to increase the stiffness of the tubular elongate body. In one embodiment, the conduit1314can have variable stiffness along its length provided by polyurethane having various levels of stiffness.

In another embodiment, the push wire1324can be used to move the implantable device1310at least partially through the channel1344of the sheath.1346. The push wire1324has an elongate push wire body1326having a push wire rear end1326A and a push wire front end1326B. The push wire front end1326B can have any shape suitable for advancing the implantable device1310in the channel1344of the sheath1346and/or the tissue. The elongate push wire body1326has a diameter suitable for moving longitudinally in the push wire lumen1317of the conduit1314. The longitudinal movements of the push wire1324includes moving the push wire1324along its own longitudinal axis (which is also substantially parallel to the longitudinal axis of the conduit1314).

The push wire1324and the conduit1314can optionally be configured to allow the push wire to be used to rotate, or to aid the rotation of, the implantable device1310. In some embodiments, as illustrated inFIG.13, the pulse push wire front end1326B is configured to include a driver1327, and the conduit front end1314B is configured to include a drive1328that is shaped to mate the driver1327. For example, the driver1327can have a shape similar to the front end of a screw driver, and the drive1328can have a shape of the drive in a screwhead that corresponds to the shape of the screw driver (e.g., slot, Phillips, square, hex, or another standard or nonstandard screw drive shape). In other embodiments in which the push wire1324is not intended to be used for rotating the implantable device1310, the driver1327and the drive1328are unnecessary and may not be included.

In this document, terms including “substantial”, “substantially”, “approximate”, “approximately”, or the like can refer to imperfection or inaccuracy resulting from practical factors including, but not limited to, accuracy in manual handling and errors within manufacturing tolerances. For example, the longitudinal axes of the push wire and the push wire lumen of the conduit can be “substantially parallel” when the former is partially placed in the latter because they are not perfectly parallel due to (1) errors within their manufacturing tolerances, (2) manually controlled movements of the push wire in the push wire lumen, and (3) a portion of the push wire is not in the push wire lumen, among other things. Such terms (“substantial”, “substantially”, “approximate”, “approximately”, or the like” can also refer to small deviations by design. For example, a push wire lumen can be “substantially parallel” to the longitudinal axes of the conduit while a small portion of the push wire lumen next to the inlet (on a lateral side of the conduit) deviates from being parallel to the longitudinal axes of the conduit by design. In a multi-lumen implantable device, the push wire lumen can be “substantially parallel” to the longitudinal axes of the conduit. While a major portion of this push wire lumen can be off-center in the conduit to allow space for inflation lumen, the front-end portion of the push wire lumen can deviate from being parallel to the longitudinal axes of the conduit to end at the center of the front end of the conduit.

FIG.14is an illustration of an implantable device kit1420, including an implantable device1410, the sheath1346, and optionally the push wire1324, according to an embodiment of present subject matter. The implantable device1410, the sheath1346, and optionally the push wire1324can be provided as a device kit1420, which can also include other accessories (e.g., surgical tools for inserting the sheath1346into tissue, such as one or more trocars for use with the sheath, as discussed with reference toFIGS.7-9above). The implantable device1410can be used to coapt a lumen in a body, and can include an adjustable membrane element (also referred to as a balloon)1412, an elongate conduit1414, a rear port1416, and a fixation mechanism1350. The adjustable membrane element1412is configured to coapt the lumen and includes a continuous wall having an inner surface defining a chamber. The rear port1416includes a conical strain relief1425(e.g., made of silicone or biostable segmented polyurethane) coupled to a port base1423. The conduit1414has a conduit rear end1414A coupled to the rear port1416within the strain relief1425, a conduit front end1414B coupled to the adjustable membrane element1412, a peripheral surface connected to and sealed to the adjustable membrane element1412near the conduit front end1414B, and an inflation lumen1415extending longitudinally in the conduit1414. The inflation lumen1415has a lumen rear opening1415A at the conduit rear end1414A, a lumen front opening1415B in fluid communication with the chamber of the adjustable membrane element1412to allow for expansion of the adjustable membrane element1412by injecting a fluid into the chamber and contraction of the adjustable membrane element1412by withdrawing the fluid from the chamber, and a lumen front end1415C to allow the push wire1324to advance the implantable device1410in the tissue and/or to operate fixation mechanism1450. Lumen front end1415C is a closed end that does not allow the fluid to leak out of the lumen1415.

The rear port1416is coupled to the conduit1414with the conduit rear end1414A in the strain relief1425. The port base1423includes a cavity1419in fluid communication with the chamber of the adjustable membrane element1412though the inflation lumen1415to allow for expansion of the adjustable membrane element1412by injecting a fluid into the chamber and contraction of the adjustable membrane element1412by withdrawing the fluid from the chamber. The cavity1419is sealed by a septum1418that is elastic and self-sealing after being pierced through, for example by a hollow needle coupled to a syringe for injecting and withdrawing the fluid, In some embodiments, the rear port1416is releasably coupled to the conduit rear end1414A. In various embodiments, the exterior surface of the port base1423is covered by a lining made of a material such as a silicone- or polyurethane-based copolymer. For example, the lining can include a thin layer formed by extending the strain relief1425to cover a substantial portion of the port base1423or the entire port base1423.

In one embodiment, the outer surface of the rear port1416and the adjustable membrane element1412are of a size (e.g., a diameter) that is smaller than an inner size (e.g., a diameter) of the channel1344to allow the implantable device1310to be moved longitudinally through the channel1344of the sheath1346. In an alternative embodiment, the rear port1416is constructed of at least one material flexible enough to allow the size of the rear port1416in its relaxed state to be compressed to a size sufficiently small so that the implantable device1410can be moved longitudinally through the channel1344. In one embodiment, the conduit1414has a stiffness sufficient to allow force applied at the conduit rear end1414A (e.g., through the rear port1316) to move the implantable device1410at least partially through the channel1344. In this embodiment, the push wire1324is optional, and the implantable device kit1420may only include the implantable device1410and the sheath1346. In one embodiment, the stiffness of the conduit1414is determined based on the type of material used in constructing its tubular elongate body. For example, the conduit1414can be made of polyurethane or silicone. The conduit1414made of polyurethane would be substantially stiffer than the conduit1414made of silicone. Alternatively, support elements can be added to the tubular elongate body of the conduit1414. For example, a metal coil can be placed longitudinally within the tubular elongate body to increase the stiffness of the tubular elongate body. In one embodiment, the conduit1414can have variable stiffness along its length provided by polyurethane having various levels of stiffness.

In another embodiment, the push wire1324can be used to move the implantable device1310at least partially through the channel1344of the sheath1346. The implantable device1410can be a single-lumen implantable device with the inflation lumen1415also functioning as a push wire lumen. The inflation lumen1415can meet the requirements for the push wire lumen1317as discussed above, with the push wire lumen inlet being the inflation lumen rear end1415A. The push wire1324can enter inflation lumen1415by piercing through the septum1418.

The helix1350is coupled to the conduit front end1414B to function as a fixation mechanism that limits displacement of the implantable device1410in the tissue after implantation by anchoring the implantable device1410to the tissue. In various embodiments, the implantable device1410can be anchored to the tissue by extending the helix1350into a portion of the tissue using a rotational movement of the implantable device1410in a tightening direction (e.g., a clockwise direction). In some embodiments, the implantable device1410can be released from the tissue by disengaging the helix1350from the portion of the tissue using a rotational movement of the implantable device1410in a loosening direction (e.g., a counterclockwise direction) when, for example, the implantable device1410needs to be repositioned in the tissue or removed from the tissue. This may be done, for example, by introducing the push wire1324to rotate the implantable device1410or to aid such rotation. In various embodiments, the implantable device1410can also be released from the tissue by disengaging the helix1350from the portion of the tissue by pulling the implantable device1410(i.e., the pull-out release), with the helix1350being configured to avoid unacceptable level of tissue damage and/or device breakage resulting from the pulling. For example, the amount of pull-out force is to be small enough to prevent the implantable device1410from being broken and leaving a portion inside the patient.

The push wire1324and the conduit1414can optionally be configured to allow the push wire to be used to rotate, or to aid the rotation of, the implantable device1410. In some embodiments, as illustrated inFIG.14, the pulse push wire front end1326B is configured to include the driver1327, and the conduit front end1414B is configured to include a drive1428that is shaped to mate the driver1327. For example, the driver1327can have a shape similar to the front end of a screw driver, and the drive1428can have a shape of the drive in a screwhead that corresponds to the shape of the screw driver (e.g., slot, Phillips, square, hex, or another standard or non-standard screw drive shape). In other embodiments in which the push wire1324is not intended to be used for rotating the implantable device1310, the driver1327and the drive1428are unnecessary and may not be included.

The implantable device1410can be combination of the helix1350with a suitable implantable device selected from those discussed with reference toFIGS.1-12, including but not limited to the implantable device510or an implantable device including various combinations of features of the implantable devices110,510, and1010.

In various embodiments, the implantable device1310and the1410implantable device can have substantially similar sizes. For example, adjustable membrane element1312and adjustable membrane element1412can have substantially similar sizes, the elongate conduit1314and the elongate conduit1414can have substantially similar sizes, and the rear port1316and the rear port1416can have substantially similar sizes.

FIGS.15-19are illustrations of a method for placing an implantable device1510into tissue of a patient using the sheath1346, according to an embodiment of present subject matter. Implantable device1510can be used to coapt a lumen in a body and can include an adjustable membrane element (also referred to as a balloon)1512, an elongate conduit1514, a rear port1516, and a helix1350. Examples of the implantable device1510includes the implantable device1310(with the adjustable membrane element1512, the elongate conduit1514, the rear port1516corresponding to the adjustable membrane element1312, the elongate conduit1314, the rear port1316, respectively) and the implantable device1410(with the adjustable membrane element1512, the elongate conduit1514, the rear port1516corresponding to the adjustable membrane element1412, the elongate conduit1414, the rear port1416, respectively). The embodiment as illustrated inFIGS.15-19is discussed by way of example, but not by way of limitation, to show how the implantable device1510can be placed in and anchored to the tissue. For example, while no push wire is used in the illustrated embodiment, a push wire can be used in various embodiments in which the implantable device1510is configured to receive a portion of the push wire for advancing the implantable device1510in the channel1344of the sheath1346and/or the tissue. During the performance of the method, portions of the implantable device1510and the sheath1346that has entered the patient can be seen using a medical imaging technique such as fluoroscopy or ultrasound.

FIG.15shows that the implantable device1510is partially placed in the channel1344of the sheath1346through the slot middle portion1348C, after the sheath is placed to allow placement of the adjustable membrane element1512at a target site of the patient. The sheath1346has a sheath rear portion including the slot rear portion1348A, a sheath front portion including the slot front end1348B, and a sheath middle portion including the slot middle portion13480. The slot middle portion1348C is sized to allow the adjustable membrane element1512and the elongate conduit1514to be placed in the channel1344when the adjustable membrane element1512is substantially deflated. The slot front portion1348B is substantially narrower than the slot middle portion1348C to form a substantially closed portion of the channel1344at the sheath front portion to guide the substantially deflated adjustable membrane element1512into the sheath front portion. The narrower slot front portion1348B also prevents the adjustable membrane element1512from exiting the channel1344when being advanced within the channel1344at the sheath front portion.

FIG.16shows that the adjustable membrane element1512of the implantable device1510advanced into the sheath front portion (which includes the slot front portion1348) such that the helix1350extends from the sheath1346, as can be seen using fluoroscopy or ultrasound. The adjustable membrane element1512is inflated to an extent such that it fills the portion of the channel1344in the sheath front portion and grips the inside of the sheath so that it rotates with the sheath1346when the sheath1346is rotated thus turning helix1350attached to conduit114or514into the tissue for fixation. This requires a relatively small volume (e.g., on the order of 0.1 cc). Over-inflation at this point may cause a portion of the adjustable membrane element1512to protrude from (or bulge out of) the sheath1346through the slot front portion1348B, a scenario further discussed below with reference toFIGS.20and21.

Due to the high sensitivity to the volume of the adjustable membrane element1512for resisting rotation (i.e., slipping) of the adjustable membrane element1512relative to the sheath with substantially limited protrusion through the slot front portion1348B, inflation the adjustable membrane element1512at this point of performance of the method needs to be precisely controlled. In one embodiment, a small volume syringe, such as 1.0 cc, can be used for fine volume control in inflating the adjustable membrane element1512. In another embodiment, the adjustable membrane element1512can be inflated to a specified pressure. This can be done, for example, using a pressure gauge on a syringe or a T connector coupled between the syringe and the adjustable membrane element1512. By controlling the pressure rather than the volume, the method can be performed with a single syringe for inflating the adjustable membrane element1512for the rotational stability first and the coaptation of the body lumen later. In various embodiments, when desired, this volume sensitivity can be reduced with a looser fit, either by increasing the diameter of the sheath1346and/or decreasing the diameter of the adjustable membrane element1512(in its deflated state).

In various embodiments, the adjustable membrane element1512can be configured for desirable characteristics related to its protrusion through a slot. In various embodiments, the rotational stability (i.e., slipping resistance) of the adjustable membrane element1512in the sheath1346can be increased by incorporating gripping features to a portion of the channel1344in the sheath front portion (with the slot front portion1348B) to prevent the adjustable membrane element1512from slipping in the sheath front portion. Examples of such features include texture and shallow longitudinal grooves or ridges on surface of the portion of the channel1344(i.e., the interior surface of the sheath front portion).

After the adjustable membrane element1512is fixed in the sheath front portion to prevent its rotation relative to the sheath1346with the helix1350extending into the tissue at the target site, the sheath1346is rotated in a tightening direction to turn the helix1350into the tissue. The number of rotations needed to provide a desirable level of fixation can be determined with testing and experience for each of different types of the tissue that the implantable device1510can anchor into (e.g., scar, muscle, or fat). The desirable level of fixation can provide the implantable device1510with sufficient fixation to prevent the adjustable membrane element1512from migration until encapsulation has occurred, In various embodiments, the desirable level of fixation also allowing for removal of implantable device1510by the pull-out release (without actively disengaging the helix1350from the tissue) without causing tissue damage and/or device breakage.

FIG.17shows that the sheath1346is withdrawn to allow inflation of the adjustable membrane element1512after the helix1350has been turned into the tissue. The adjustable membrane element1512is deflated to allow the withdrawal of the sheath1346before it is inflated in tissue.

FIG.18shows that the adjustable membrane element1512is inflated (e.g., to a volume of 2-3 cc) at the tissue site. Proper positioning of the adjustable membrane element1512can be confirmed by observing coaptation (e.g., flattening) of the body lumen (e.g., urethra) with the fluoroscopy or endoscopy. If the position is to be adjusted, the adjustable membrane element1512can be deflated, returned into the sheath front portion, inflated to re-fix the adjustable membrane element1512in the sheath front portion to prevent it from rotating relative to the sheath1346, and actively disengage the helix1350from the tissue by rotating the sheath1346in the loosening direction. The steps as discussed above with reference toFIGS.16-18can be repeated until the positioning of the adjustable membrane element1512is satisfactory. Alternatively, the steps as discussed above with reference toFIGS.15-18can be partially performed, by skipping the turning of the helix1350, until the proper positioning of the adjustable membrane element1512is confirmed. Then, the adjustable membrane element1512is deflated, the sheath1346is advanced such that the sheath front portion is over the adjustable membrane element1512, and the steps as discussed above with reference toFIGS.16-18can be performed to anchor the implantable device1510into the tissue at the target site.

FIG.19shows that the sheath1346is withdrawn until the rear port1516reaches the transition between the slot middle portion1348C and the slot front portion1348B, after the implantable device1510is anchored into the tissue at the target site and the proper positioning of the adjustable membrane element1512is confirmed. As illustrated inFIG.19, the rear port1516has a conical strain relief at the transition between the rear port1516and the conduit1514. In one embodiment, the transition between the slot middle portion1348C and the slot front portion1348B engages the conical strain relief of the port1516to prevent damage to the conduit1514while the port1516is pushed and/or the sheath1346is pulled to separate the implantable device1510form the sheath1346. The strain relief can have enough elastic bulk to resist any significant damage. In another embodiment, the conduit1514and the sheath1346are configured to allow the conduit1514to be stretched to have a diameter smaller than the width of the slot front portion1348B. The sheath1346can then be separated from the implantable device1510by passing the stretched conduit1514through the slot front portion1348B. In another embodiment, in which the slot front portion1348B is replaced by a slit or a very narrow slot, the slit or narrow slot can be opened using a tool (e.g., internal snap ring plyers) to allow the sheath1346to be separated from the implantable device1510.

After the implantable device1510is placed in and anchored to the tissue at the target site, and the sheath1346is separated from the implantable device1510, the implantable device may need to be removed from the patient, for example for device repositioning or replacement when the patient's condition has changes and/or when a more suitable device is available. In one embodiment, the sheath1346can be inserted into the patient and engaged with the implantable device1510, for example by placing an exposed section of the conduit1514through the slot front portion1348B and advancing the sheath1346until the adjustable membrane element1512(which has been deflated) is within the sheath front portion. The adjustable membrane element1512is then inflated to the extent allowing the helix1350to be actively disengaged from the tissue by rotating the sheath1346in the loosening direction. In another embodiment, the implantable device1510is removed using the pull-out release. In one embodiment, the helix1350is made of a bioresorbable material, as discussed above, which makes removal of the implantable device1510by the pull-out release (or any pulling method for removing for repositioning the implantable device1510) easier and safer after the helix1350substantially degrades.

FIGS.20-21are illustrations of a scenario in performing the method ofFIGS.15-19and device features related to the scenario, according to an embodiment of present subject matter.FIG.20shows the adjustable membrane element1512of the implantable device1510protruding from a portion of the slot of the sheath1346(e.g., the slot front portion1348B).FIG.21is a longitudinal cross-sectional view of the adjustable membrane element1512from the slot front portion1348B of the sheath1346. As discussed above with reference toFIG.16, over-inflation of the adjustable membrane element1512may cause a portion of it to protrude from the sheath1346through the slot front portion1348B, thereby exposing the adjustable membrane element1512to the risk of damage from edges of the slot front portion1348B. Such protrusion can be observed, for example, using fluoroscopy. On the other hand, limited protrusion of the adjustable membrane element1512from the slot front portion1348B can add rotational stability (i.e., slipping resistance) of the adjustable membrane element1512in the sheath1346. In this instance, extra care should be taken so that the edges of the slot be smooth and rounded. In various embodiments, as illustrated inFIG.21, the slot front portion1348B has two slot edges each including a round inner edge1349(directly coupled to the interior surface of the sheath1346) having an inner radius and a round outer edge1350(directly coupled to the exterior surface of the sheath1346) having an outer radius. The inner radius and the outer radius can be experimentally determined for preventing the adjustable membrane element1512from damages caused by the protrusion of the adjustable membrane element1512from the sheath1346through the slot front portion1348B, with the inner radius being larger than the outer radius. In various embodiments, the entire slot1348can have such inner and outer edges. Additionally, the edges of the slot1348, or the entire elongate cylindrical sheath body1345, can be treated with a lubricous coating such as parylene to further prevent the adjustable membrane element1512from being damaged.

In various embodiments, the volume of the adjustable membrane element1512during each step in performing the method illustrated inFIGS.15-19can be empirically determined to ensure that each step can be performed as intended. Various factors determining an adequate volume for each step including, but not limited to, the torque needed to rotate the implantable device1510with the sheath1346, the amount of protrusion of the adjustable membrane element1512from the sheath1346through the slot front portion1348B that is allowed and/or desired, characteristics of the interior surface of the sheath1346, and/or durability of the adjustable membrane element1512.

Some non-limiting examples (Examples 1-21) of the present subject matter are provided as follows:

In Example 1, an implantable device configured to be positioned in tissue of a living body for coaptation of a body lumen of the living body is provided. The implantable device may include an adjustable membrane element, an elongate conduit, a rear port, and a helix. The adjustable membrane element may be configured to coapt the body lumen and including a continuous wall having an inner surface defining a chamber. The elongate conduit may include a conduit peripheral surface, a conduit rear end, a conduit front end, and one or more conduit lumens The conduit peripheral surface may be connected to and sealed to the adjustable membrane element at or near the conduit front end. The one or more conduit lumens may include at least an inflation lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end. The rear port may be connected to the elongate conduit at the conduit rear end and include a cavity in fluid communication with the first opening of the inflation lumen. The helix may be coupled to the conduit front end and configured to anchor the implantable device to the tissue by rotating the entire implantable device in a tightening direction.

In Example 2, the subject matter of Example 1 may optionally be configured such that the rear port includes a strain relief and a port base coupled to the strain relief and is connected to the elongate conduit with the conduit rear end in the strain relief.

In Example 3, the subject matter of any one or any combination of Examples 1 and 2 may optionally be configured such that the implantable device includes one or more elastic portions each constructed of biostable segmented polyurethane.

In Example 4, the subject matter of any one or any combination of Examples 1 to 3 may optionally be configured such that the helix is constructed of a bioresorbable material.

In Example 5, an implantable device kit for controllable coaptation of a body lumen in tissue of a target site in a living body is provided. The implantable device kit may include an implantable device and a sheath. The implantable device may include an adjustable membrane element, an elongate conduit, a rear port, and a helix. The adjustable membrane element may be configured to coapt the body lumen and include a continuous wall having an inner surface defining a chamber. The elongate conduit may include a conduit peripheral surface, a conduit rear end, a conduit front end, and one or more conduit lumens. The conduit peripheral surface may be connected to and sealed to the adjustable membrane element at or near the conduit front end. The one or more conduit lumens may include an inflation lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end. The rear port may be connected to the conduit rear end and include a cavity in fluid communication with the first opening of the inflation lumen. The helix may be coupled to the conduit front end and configured to anchor the implantable device to the tissue. The sheath may be configured to accommodate portions of the implantable device including the adjustable membrane element, to guide the implantable device to the target site, and to be used to rotate the implantable device when the portions of the implantable device is placed in the sheath with the adjustable membrane element partially inflated.

In Example 6, the subject matter of Example 5 may optionally be configured to further include a push wire and configured such that the one or more conduit lumens further include a push wire lumen having an opening on the elongate conduit to allow the push wire to enter the push wire lumen and a closed end at or near the conduit front end to allow the implantable device to be pushed forward through the sheath by applying a forwarding force to the push wire.

In Example 7, the subject matter of any one or any combination of Examples 5 and 6 may optionally be configured such that the sheath includes an elongated body and a longitudinal slot. The elongated body includes a sheath rear portion, a sheath front portion, and a sheath middle portion coupled between the sheath rear portion and the sheath front portion. The longitudinal slot includes at least a slot middle portion extending on the sheath middle portion and a slot front portion extending on the sheath front portion. The slot middle portion is configured to allow placement of the portions of the implantable device in the sheath. The slot front portion is configured to allow the implanted device to rotate with the sheath when the adjustable membrane element is placed substantially in the sheath and partially inflated and to allow the sheath to be separated from the implantable device.

In Example 8, the subject matter of Example 7 may optionally be configured such that the sheath front portion includes an interior surface including one or more gripping features.

In Example 9, the subject matter of Example 8 may optionally be configured such that the one or more gripping features include longitudinal grooves or ridges.

In Example 10, the subject matter of any one or any combination of Examples 7 to 9 may optionally be configured such that the rear port of the implantable device includes a strain relief and a port base coupled to the strain relief and is connected to the elongate conduit with the conduit rear end in the strain relief, and at least a portion the strain relief is configured for passing the slot front portion of the sheath when the sheath is separated from the implantable device.

In Example 11, the subject matter of any one or any combination of Examples 7 to 10 may optionally be configured such that the sheath includes an interior surface and an exterior surface, the longitudinal slot is formed by two slot edges each coupled between the interior surface and an exterior surface, the two slot edges each include an inner edge directly coupled to the interior surface and having an inner radius and an outer edge directly coupled to the exterior surface and having an outer radius, and the inner radius is larger than the outer radius at least for the slot front portion.

In Example 12, the subject matter of any one or any combination of Examples 5 to 11 may optionally be configured such that the implantable device includes one or more elastic portions each constructed of biostable segmented polyurethane.

In Example 13, a method for coapting a body lumen in tissue of a target site in a living body is provided. The method may include providing an implantable device. The implantable device may include an adjustable membrane element, an elongate conduit, a rear port, and a helix. The adjustable membrane element may be configured to coapt the body lumen and including a continuous wall having an inner surface defining a chamber. The elongate conduit may include a conduit peripheral surface, a conduit rear end, a conduit front end, and one or more conduit lumens The conduit peripheral surface may be connected to and sealed to the adjustable membrane element at or near the conduit front end. The one or more conduit lumens may include an inflation lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end. The rear port may be connected to the conduit rear end and including a cavity in fluid communication with the first opening of the inflation lumen. The helix may be coupled to the conduit front end. The method may further include rotating the implantable device in a tightening direction to turn the helix into the tissue upon placement of the implantable device at the target site.

In Example 14, the subject matter of Example 13 may optionally further include disengaging the helix from the tissue by pulling the implantable device.

In Example 15, the subject matter of providing the implantable device as found in any one or any combination of Examples 13 and 14 may optionally include constructing the helix using bioresorbable material.

In Example 16, the subject matter of any one or any combination of Examples 13 to 15 may optionally further include providing a sheath and placing portions of the implantable device including the adjustable membrane element in the sheath with the helix extending from a front end of the sheath, such that rotating the implantable device includes partially inflating the adjustable membrane element so that the implantable device rotates with the sheath and rotating the sheath.

In Example 17, the subject matter of providing the sheath as found in Examples 16 may optionally include providing a sheath including an elongated body and a longitudinal slot. The elongated body includes a sheath rear portion, a sheath front portion, and a sheath middle portion coupled between the sheath rear portion and the sheath front portion. The longitudinal slot includes a slot middle portion extending in the sheath middle portion and a slot front portion extending in the sheath front portion. The slot middle portion is wider than the slot front portion and sized to al low the placement of the portions of the implantable device in the sheath. The slot front portion is sized to allow the sheath to be separated from the implantable device by passing a portion of the elongate conduit through the slot front portion.

In Example 18, the subject matter of providing the sheath as found in any one or any combination of Examples 16 and 17 may optionally include providing a disposable sheath.

In Example 19, the subject matter of partially inflating the adjustable membrane element so that the implantable device rotates with the sheath as found in any one or any combination of Examples 16 to 18 may optionally include injecting a fluid into the cavity of the rear port of the implantable device and controlling a volume of the fluid being injected into the cavity to cause a portion of the adjustable membrane element of the implantable device to protrude through the slot front portion when the adjustable membrane element is placed in the sheath front portion.

In Example 20, the subject matter of partially inflating the adjustable membrane element so that the implantable device rotates with the sheath as found in any one or any combination of Examples 16 to 18 may optionally include injecting a fluid into the cavity of the rear port of the implantable device and controlling a pressure of the fluid being injected into the cavity.

In Example 21, the subject matter of rotating the implantable device in the tightening direction to turn the helix into the tissue as found in any one or any combination of Examples 13 to 20 may optionally include controlling an amount of the rotation based on a type of the tissue.

This application is intended to cover adaptations or variations of the present subject matter. It is to be understood that the above detailed description is intended to be illustrative, and not restrictive. Other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. The scope of the present subject matter should be determined with reference to the appended claims, along with the full scope of legal equivalents to which such claims are entitled.