IMPLANTABLE URINARY CONTINENCE DEVICE HAVING HELICAL ANCHOR - Patent application

Abstract

The implantable device includes a conduit, an adjustable membrane element coupled to the conduit near a front end thereof for controllable joining of a body lumen, such as joining of the urethra as a treatment for urinary incontinence, and a helix coupled to the front end of the conduit. The helix serves as an anchoring mechanism for anchoring the implantable device to tissue. The implantable device can be inserted into tissue using a sheath and rotated with the sheath by partially expanding the adjustable membrane element located at the front end of the sheath, and the helix can be rotated into tissue by rotating the sheath.

Description

[Technical field]

[0001] The present specification relates generally to implantable medical devices, and more particularly to devices having a spiral for anchoring the device to tissue after implantation in a patient for treating urinary incontinence. [Background technology]

[0002] One example of an implantable device for treating urinary incontinence includes an adjustable membrane element, such as a balloon, connected to a rear port by a conduit. The implantable device can be implanted in a patient through minimally invasive surgery, with the adjustable membrane element positioned adjacent to the patient's urethra and the rear port positioned under the patient's skin. The adjustable membrane element can be adjusted during and after surgery by percutaneously injecting fluid into the rear port using a needle or extracting fluid from the rear port. In an exemplary treatment, two such implantable devices are placed in a patient, such that the two adjustable membrane elements provide compression and support to the patient's bladder neck to protect against accidental leakage of urine, such as in cases of stress urinary incontinence (e.g., leakage during sneezing, coughing, or physical activity). The effectiveness 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 placement, and maintenance of the position of the adjustable membrane element over time. Summary of the Invention

[0003] The implantable device includes a conduit, an adjustable membrane element coupled to the conduit near a forward end thereof for controllable coaptation of a body lumen, such as coaptation of the urethra as a treatment for urinary incontinence, and a helix coupled to the forward end of the conduit. The helix serves as an anchoring mechanism for anchoring the implantable device to tissue. The implantable device can be inserted into tissue using a sheath and rotated with the sheath by partially expanding an adjustable membrane element located at a forward end of the sheath, and the helix can be rotated into tissue by rotating the sheath.

[0004] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details regarding the present subject matter are found in the detailed description and appended claims. The scope of the present invention is defined by the appended claims and their legal equivalents. [Brief description of the drawings]

[0005] [Figure 1] FIG. 1 is a perspective view of an implantable device and a syringe source for providing a flowable material to an adjustable membrane element of the implantable device, according to an embodiment of the present subject matter. [Diagram 2] 2 is a longitudinal cross-sectional view of the implantable device shown in FIG. 1 in accordance with an embodiment of the present subject matter. [Diagram 3] FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2, in accordance with an embodiment of the present subject matter. [Figure 4] 1 after being placed at a desired location within a patient and expanded to displace body tissue toward a body lumen to cause adjustable constraint of the body lumen, according to an embodiment of the present subject matter. [Diagram 5] 1 is a longitudinal cross-sectional view of another implantable device, in accordance with an embodiment of the present subject matter. [Figure 6] FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5, in accordance with an embodiment of the present subject matter. [Figure 7] 1 illustrates a sheath used for implantation of an implantable device, according to an embodiment of the present subject matter. [Figure 8] 8 illustrates a trocar for use with the sheath of FIG. 7, according to an embodiment of the present subject matter. [Figure 9] 9 illustrates an assembly of the sheath of FIG. 7 with the trocar of FIG. 8 according to an embodiment of the present subject matter. [Figure 10] 9A-9C are diagrams, including cutaway views, illustrating the introduction of an implantable device into a patient's tissue to provide urethral coaptation using an assembly of the sheath of FIG. 7 and the trocar of FIG. 8 in accordance with an embodiment of the present subject matter. [Figure 11] 1A-1C are diagrams, including cutaway views, illustrating a pair of implantable devices being placed in a patient to provide urethral coaptation, in accordance with an embodiment of the present subject matter. [Figure 12] 12A-12C are diagrams, including cutaway views, illustrating adjustment of the urethral coaptation after a pair of implantable devices have been placed in a patient as shown in FIG. 11, according to an embodiment of the present subject matter. [Figure 13] 1 is a diagram of an implantable device, a push wire, and a sheath, according to an embodiment of the present subject matter. [Figure 14] 1 is a diagram of another implantable device, a push wire, and a sheath in accordance with an embodiment of the present subject matter. [Figure 15] 15 is a diagram of a method for placing an implantable device in a patient using a sheath, according to an embodiment of the present subject matter.FIG 15 shows an implantable device partially placed in a sheath. [Figure 16] 16 shows a method for positioning an implantable device in a patient using a sheath, according to an embodiment of the present subject matter. FIG. 16 shows an adjustable membrane element of the implantable device advanced into the front of the sheath and partially expanded to allow the spiral of the implantable device to rotate into tissue. [Figure 17]17 shows a sheath being partially withdrawn to allow for expansion of an adjustable membrane element; [Figure 18] 17-19 are diagrams of a method for positioning an implantable device in a patient using a sheath, according to embodiments of the present subject matter.FIG 18 shows the adjustable membrane element being inflated for joining of a body lumen of a patient. [Figure 19] 19 shows a method for placing an implantable device in a patient using a sheath, according to an embodiment of the present subject matter. FIG. 19 shows the sheath being retracted to allow the sheath to be separated from the implantable device. [Figure 20] 15-19 according to embodiments of the present subject matter, and device features associated with the scenarios during implementation of the method of FIG. 20. FIG. 20 shows an adjustable membrane element of an implantable device protruding from a slot in a sheath. [Figure 21] 15-19 according to embodiments of the present subject matter, and device features associated with the scenarios during implementation of the method of FIG. 21. FIG. 21 is a longitudinal cross-sectional view of an adjustable membrane element of an implantable device protruding from a slot in a sheath. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The following detailed description of the present subject matter refers to subject matter in the accompanying drawings, which show, by way of illustration, specific aspects and embodiments in which the present subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. References in this disclosure to "an," "one," or "various" embodiments are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is illustrative and is not to be taken in a limiting sense. The scope of the present subject matter is defined by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.

[0007] This specification discusses, among other things, mechanisms and tools for fixing an implantable device to surrounding tissue to treat urinary incontinence. The implantable device may include, for example, an adjustable membrane element connected to a rear port by a conduit, the conduit having a lumen providing fluid communication between a chamber of the adjustable membrane element and an internal cavity of the rear port. Various structural elements of the implantable device described herein (e.g., implantable device 110 shown in FIG. 1) may each be referred to by various terms. The "adjustable membrane element" (e.g., adjustable membrane element 112 shown in FIG. 1) may also be referred to, for example, as an adjustable element, an expandable element, an expandable membrane element, a front expandable membrane element, a balloon, or an adjustable balloon. The "conduit" (e.g., conduit 114 shown in FIG. 1) may also be referred to, for example, as a central conduit element, a device conduit, a connecting conduit, a connecting conduit tube, or a tubular elongated body. The "rear port" (e.g., rear port 116 shown in FIG. 1) may also be referred to, for example, as a rear port portion or a rear port element. The "lumens" (eg, first lumen 115 and second lumen 117 shown in FIG. 2) may also be referred to as, for example, passages, inner passages, or internal passages.

[0008] In one example, the implantable device includes an adjustable balloon connected to the port by a conduit. The balloon is positioned adjacent to the urethra and applies non-circumferential compression to the urethral wall. The effectiveness of the treatment depends on proper positioning of the balloon at a target site within the patient's body, such as the retropubic space near the urethral-vesical junction above the urogenital diaphragm in close proximity to the urethral wall. When two balloons (e.g., of two implantable devices) are used, their preferred positioning is usually symmetrical and lateral to the urethra. Medical imaging techniques, such as fluoroscopy or transrectal ultrasonography (TRUS), may be used to assist in the positioning of the balloon(s). As discussed in U.S. patent application Ser. No. 16 / 450,246, filed June 24, 2019, and assigned to UroMedica, Inc., which is incorporated by reference in its entirety, sensors incorporated into the implantable device(s) and / or one or more surgical tools may also be used to assist in positioning the balloon(s).

[0009] During the implantation procedure, the implantable device(s) are placed in the patient's body with the balloon(s) positioned and fixed in place at the target site(s). The balloon(s) are only slightly inflated, typically between 0.5-1.5 cc, over a period of 4-6 weeks to allow tissue encapsulation to stabilize the balloon(s) at its(their) target site(s). Notably, without encapsulation, the implantable device(s) will tend to migrate down the dilation pathway through which the implantable device(s) were implanted. For optimal effectiveness, it is important that the balloon(s) are maintained above the pelvic floor. It is therefore very important that fixation occurs during this implantation procedure. After encapsulation, the patient may undergo one or more adjustment procedures to adjust the volume of fluid within the balloon(s) in order to achieve and maintain continence without causing undesirable obstruction.

[0010] The present subject matter provides an implantable device for treating urinary incontinence, the implantable device having a helical fixation mechanism for preventing undesired displacement of the balloon of the implantable device. Figures 1-9 show various embodiments of an implantable device that may incorporate a helical fixation mechanism and a surgical tool used to position the implantable device within a patient's body. Various embodiments of the implantable device and surgical tool are shown in Figures 1-9 and described below by way of example and not by way of limitation. These examples, as well as additional examples of implantable devices and surgical tools, are discussed in U.S. Patent Nos. 5,964,806, 6,045,498, 6,419,624, 6,579,224, 8,926,494, and 9,861,384, all of which are assigned to UroMedica, Inc. and are incorporated herein by reference in their entireties. Figures 10-12 show an example of the placement and adjustment of a pair of implantable devices for urethral coaptation in a post-prostatectomy patient. 13-19 illustrate a helical fixation mechanism incorporated into an implantable device and the process of placing the implantable device within a patient's tissue and fixating the implantable medical device to the tissue.

[0011] FIG. 1 is a perspective view of an implantable device 110 and a syringe 120, according to an embodiment of the present subject matter. FIG. 2 shows a longitudinal cross-sectional view of the implantable device 110. FIG. 3 is a cross-sectional view of the implantable device 110 taken along line 3-3 of FIG. 2. The implantable device 110 includes an adjustable membrane element (also called a balloon) 112, shown in an expanded state in FIG. 1, that is pressure-tightly attached to an elongated conduit 114. The conduit 114 has a front end 160. In one embodiment, the periphery of the conduit 114 is connected to and sealed to the adjustable membrane element 112. In one embodiment, the adjustable membrane element 112 includes a continuous wall having an inner surface that defines a chamber.

[0012] The conduit 114 includes a first lumen 115 and a second lumen 117 (as shown in Figures 2 and 3). In one embodiment, the first lumen 115 extends longitudinally within the conduit 114 from a first opening 115A to one or more second openings 115B (e.g., two openings as shown in Figure 2). The second opening(s) 115B are in fluid communication with a chamber of the adjustable membrane element 112 to adjustably expand or contract the adjustable membrane element 112 with a flowable material introduced through the first opening 115A. To prevent leakage of fluid from the adjustable membrane element 112, the first lumen 115 has a closed end at or near the front end 160 of the conduit 114. The closed end may be formed by sealing the front end of the first lumen 115 using, for example, a silicone adhesive. Alternatively, the first lumen 115 may be closed by manufacturing it to terminate before reaching the front end of the conduit 1014 .

[0013] Second lumen 117 extends longitudinally along conduit 114 from inlet 117A to a closed end 117B at front end 160. In one embodiment, second lumen 117 and inlet 117A are each of sufficient diameter to accommodate a push wire (also referred to as a push rod) that may be used to advance implantable device 110 within tissue.

[0014] The implantable device 110 further includes a rear port 116 coupled to the rear end of the conduit 114. In one embodiment, it includes a cavity 116A and an elastic septum 118. The cavity 116A is coupled to and in fluid communication with the first lumen 115 at the first opening 115A. The elastic septum 118 allows access to the cavity 116A using a needle (such as the needle 121 shown in FIG. 1) to introduce and / or withdraw fluid to expand (inflate) and / or contract (deflate) the adjustable membrane element 112. The diameter of the elastic septum 118 can be slightly larger than the diameter of the cavity 116A to create compression in the elastic septum 1018 for better sealing. A syringe 120 including a hollow needle 121 and a rear axially movable plunger 122 is provided for injecting or withdrawing a suitable flowable material into or from the implantable device 110 through the rear port 116 to expand or contract, respectively, the adjustable membrane element 112. In various embodiments, the flowable material may be, for example, saline, a polymer gel such as a silicone gel or hydrogel of polyvinylpyrrolidone, polyethylene glycol, or carboxymethylcellulose, or a high viscosity liquid such as hyaluronic acid, dextran, polyacrylic acid, or polyvinyl alcohol. If desired, the flowable material may be made radiopaque (such as an isotonic contrast agent) so that the extent of membrane expansion may be seen by x-ray, or echogenic so that it may be seen by ultrasound.

[0015] In one embodiment, as shown in FIG. 2, the rear port 116 includes a titanium port liner 111 and an overmold 113. The port liner 111 surrounds the cavity 116A and a portion of the septum 118 to prevent the needle 121 from piercing the rear port 116 from the inside or to prevent the needle 121 from piercing the rear port 116 if misdirected from the outside. The inner diameter of the port liner 111 can be slightly smaller than the enclosed portion of the septum 118 to provide compression for a better seal. As shown in FIG. 2, the port liner 111 includes a cylindrical portion that surrounds the cavity 116A and a cap connected to the cylindrical portion. The cap has a hole that allows fluid communication between the cavity 116A and the first lumen. The hole can have a diameter smaller than the diameter of the needle to prevent the needle from penetrating forward beyond the cavity 116A. The overmold 113 may be made from silicone or a biostable segmented polyurethane elastomer and molded over the port liner 111 and a real portion of the conduit 114 to connect the rear port 116 to the conduit 114. The overmold 113 includes a tapered portion that acts as a strain relief to protect the conduit 114, including the connection between the conduit 114 and the rear port 116, from damage that may result from, for example, cyclic bending due to body movement while the implantable device 110 is implanted in a patient, or from straining during removal of the implantable device 110 from tissue.

[0016] The entire implantable device 110, including the adjustable membrane element 112, is formed from biocompatible materials, including, for example, silicone or polyurethane-based elastomers, and metals such as titanium or tantalum suitable for long-term implantation. Optionally, the conduit 114 and rear port 116 can be formed as a unitary structure. Optionally, the implantable device 110 includes one or more elastic portions each constructed from a biostable segmented polyurethane, which is a polyurethane with flexible segments of macrodiols selected for biostability. This biostability is the ability of a polymer to resist degradation, such as by stress cracking, in the body over time as expected for long-term implantation. Silaxane, polyether, and polycarbonate macrodiols are known to impart biostability to segmented polyurethanes and can be used in any combination to impart properties such as toughness, cut resistance, abrasion resistance, and lack of permeability superior to silicone. Additionally, being thermoplastic, the macrodiols allow for the adjustable membrane element 112 to be blow molded at greatly reduced costs, and in some cases, to use additive manufacturing such as 3D printing. The adjustable membrane element 112 can be attached to the conduit 114 using a suitable adhesive or by means such as sonic welding or solvent bonding. Examples of silicone-based materials include polydimethylsiloxane (PDMS), which has a variety of formulations depending on the intended application, such as injection molding, extrusion, a dispersion for dip molding over a mandrel, or as an adhesive.

[0017] FIG. 4 illustrates an implantable device 110 after being placed in a desired location in a patient and expanded to displace body tissue toward a body lumen 432 to cause adjustable restraint of the body lumen 432, according to an embodiment of the present subject matter. After the implantable device 110 is positioned in a patient such that the adjustable membrane element 112 in a contracted state is in a desired location adjacent the body lumen 432 (e.g., using a method using a surgical tool as described below with reference to FIGS. 7-10), the body lumen 432 can be restrained to a desired degree by piercing the septum 118 with a needle 121 of a syringe 120 and injecting a flowable material through the first lumen 115 into the adjustable membrane element 112. A physician can determine the desired degree of restraint of the body lumen 432 by means such as injecting fluid through the restraint and through the body lumen 432 to measure back pressure. In one embodiment, the body lumen is the urethra, as described further below with reference to FIGS. 10-12.

[0018] After the implantable device 110 is properly positioned, with the adjustable membrane element 112 positioned adjacent to the body lumen 432 and the septum 118 in the rear port 116 positioned adjacent to the skin 430, the device is injected with flowable material from the syringe 120. The adjustable membrane element 112 is allowed to expand to a certain extent and then contract to a degree suitable for encapsulation of the adjustable membrane element 112 by the body tissue.

[0019] The present subject matter provides an implantable device 110 with adjustability of post-operative membrane expansion. This adjustability is provided because the septum 118 is positioned separate from the adjustable membrane element 112, but beneath and proximate to the patient's skin, for example, within the scrotum of a male patient or the labia of a female patient. The rear port 116 and septum 118 are located, for example, by manual palpation of the skin area, and a needle 121 of a syringe 120 is inserted through the skin and septum 118 to add or remove flowable material from the adjustable membrane element 112, thus increasing or decreasing the restriction of the body lumen 432.

[0020] Figure 5 is a longitudinal cross-sectional view of an implantable device 510 in accordance with an embodiment of the present subject matter. Figure 6 is a cross-sectional view of the implantable device 510 taken along line 6-6 of Figure 5. The implantable device 510 includes an adjustable membrane element (also referred to as a balloon) 512 and an elongate conduit 514 including at least a first lumen 515 extending longitudinally within the conduit 514 from a first opening 515A at a rear end (also referred to as a proximal end) of the conduit to a second opening 515B.

[0021] Implantable device 510 further includes a rear port 516, which is coupled to the rear end of conduit 514. In one embodiment, rear port 516 is coupled to the rear end of elongated body 514 using a chemical adhesive, or alternatively, depending on the material, using sonic welding, solvent bonding, and / or other techniques known in the art. In additional embodiments, rear port 516 and conduit 514 are formed together in a polymer molding process, such as liquid injection molding or overmolding.

[0022] The rear port 516 includes a cavity 516A, which is in fluid communication with the first opening 515A of the conduit 514. In one embodiment, the rear port 516 also includes an elastic septum 518 through which the cavity 516A is accessed, the elastic septum 518 self-sealing after repeated punctures, for example with a needle. In one embodiment, the elastic septum 518 is held within the rear port 516 by a clamp ring 519 disposed about the rear port 516. In one embodiment, the clamp ring 519 is made from a biocompatible material, for example, titanium. In one embodiment, the elastic septum 518 is made from a biocompatible material, for example, silicone or biostable segmented polyurethane. The rear port 516 has an outer diameter defined by an outer surface 554 of the rear port 516. In one embodiment, the rear port 516 has an outer diameter of 2 to 15 millimeters, with 5.7 millimeters being an example.

[0023] Once the implantable device 510 is placed within the body, the adjustable membrane element 512 is inflated by releasably connecting a flowable material source to the rear port 516. In one embodiment, the flowable material source includes a syringe with a non-coring needle, such as syringe 120 with needle 121, which is inserted through the elastic septum 518. A measured amount of fluid can be introduced into the implantable device 510, and the adjustable membrane element 112 expands or contracts due to the volume of flowable material introduced from the flowable material source into the cavity 516A of the rear port 516. The adjustable membrane element 512 is then used to adjustably restrain at least a portion of the body lumen. Once the adjustable membrane element 512 is inflated, the needle is withdrawn from the septum 518 of the rear port 516.

[0024] In an additional embodiment, a detectable marker 570 is embedded in the implantable device 510. For example, the detectable marker 570 is disposed at the leading end (also referred to as the distal end) 560 of the conduit 514. In one embodiment, the detectable marker 570 is disposed within the lumen of the conduit 514. The detectable marker 570 allows for the location of the leading end 560, and therefore the leading end of the adjustable membrane element 512, within the patient's tissue using any number of visualization techniques that use electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker 570 is constructed and positioned to allow for visualization and orientation of the adjustable membrane element 512 within the patient's tissue. In one embodiment, the detectable marker 570 is constructed from radiopaque tantalum and can be visualized with an x-ray. In one embodiment, the entire conduit 514 is made radiopaque, for example, by dispersing tantalum powder within the conduit 514. Implantable device 510 can be formed from biocompatible materials in the same or substantially similar manner as described above for implantable medical device 110. Similarly, the detectable markers can be positioned in substantially the same manner and serve substantially the same purposes as described above for implantable medical device 110.

[0025] 7-9 show a surgical tool kit for placing an implantable device, such as implantable devices 110 and 510, within a patient's tissue. The surgical tool kit includes a sheath 746 (shown in FIG. 7) and a trocar 838 (shown in FIG. 8). FIG. 9 shows an assembly 940 that includes the sheath 746 and the trocar 838.

[0026] Trocar 838 includes an elongate member (shaft) 837 and a handle portion 836. In one embodiment, trocar 838 is disposable (i.e., not intended for or suitable for reuse, e.g., not suitable for cleaning and resterilization after use). In another embodiment, trocar 838 is reusable (i.e., can be cleaned and resterilized after each use). Elongate member 837 is sterilizable in various embodiments. In additional embodiments, handle portion 836 is also sterilizable. In another embodiment, trocar 838 includes steam sterilizable components. Various embodiments incorporate materials known to provide such functionality (e.g., surgical grade stainless steel). Multiple embodiments are contemplated by the present subject matter. In each embodiment, one or more materials are used to construct elongate member 837. In each embodiment, one or more materials are used to construct handle portion 836.

[0027] Trocar 838 has a proximal end and a distal end, with a handle portion disposed at the proximal end. In one embodiment, trocar 838 has a sharp tip at the distal end. In another embodiment, trocar 838 has a blunt tip at the distal end. In one embodiment, both sharp-tipped trocar 838 and blunt-tipped trocar 838 are provided for implanting devices such as implantable devices 110 and 510.

[0028] The sheath 746 includes an elongate member (shaft) 745 and a handle portion 743. In one embodiment, the sheath 746 is disposable (i.e., not intended for or suitable for reuse, e.g., not suitable for cleaning and resterilization after use). This can provide cost-effectiveness when the sheath 746 is damaged during use (e.g., modified to facilitate separation from the implantable device during the implantation procedure). In another embodiment, the sheath 746 is reusable (e.g., can be cleaned and resterilized after each use). The elongate member 745, in one embodiment, is concave (U- or C-shaped) shaped across its diameter. In various embodiments, the elongate member 745 comprises a tube having a slotted opening extending across at least a portion of its length. The elongate member 745 has a curved cross-section in various embodiments. Thus, these embodiments define the channel 744 of the sheath 746. In various embodiments, the removable trocar is sized to be slidably disposed within the elongate member of the sheath 746 through an opening in the handle portion 743. In various embodiments, one or more materials are used in constructing the elongate member 745. In each embodiment, one or more materials are used in constructing the handle portion 743. Examples of such one or more materials include stainless steel and various suitable polymers.

[0029] The trocar 838 is inserted into the sheath 746 to form the assembly 940, as shown in FIG. 9. In one embodiment, the trocar 838 having a sharp tip is used to penetrate the patient's tissue, distal portion first, through the incision, any scar tissue that may be present, the fascia of the pelvic floor, and toward the implantation site located proximal to the patient's bladder neck or prostate (if present), such as when the physician grasps the handle 836 and manipulates the trocar 838. In various embodiments, the physician inserts the assembly 940 with the trocar 838 into the incision made in the patient and advances the assembly 940 within the patient's tissue until the trocar 838 reaches the bladder neck, and the tip of the sheath 746 is withdrawn (e.g., about 1-2 cm) to allow the adjustable membrane element 112 to be partially inflated (e.g., to about 1 cc) at the bladder neck while maintaining the position of the tip of the sheath 746 at the target site. In one embodiment, a trocar 838 having a sharp tip is used until the sharp tip reaches the patient's pelvic floor and is then replaced by a trocar 838 having a blunt tip to avoid bladder perforation when approaching the patient's bladder neck.

[0030] In various embodiments, a surgical tool kit including trocar 838 and sheath 746 is provided to a physician implanting a device such as implantable devices 110 and 510. In one embodiment, the surgical tool kit includes a trocar 838 with a sharp tip, a trocar 838 with a blunt tip, and a sheath 746. In one embodiment, the surgical tool kit including trocar(s) 838 (sharp tip and / or blunt tip) and sheath 746 is disposable, i.e., intended for a single use. Compared to reusable trocars and sheaths, disposable trocars and sheaths may be more cost-effective and / or safer (e.g., due to cost and efficacy concerns associated with cleaning and resterilization).

[0031] FIG. 10 is a diagram, including a cutaway view, illustrating the introduction of an implantable device 1010 into the tissue of a male patient after a prostatectomy using assembly 940 to provide urethral coaptation, according to an embodiment of the present subject matter. Examples of implantable devices 1010 include implantable devices 110, 510, 1310, 1410, 1510, and any of their embodiments described herein. In various embodiments, a physician inserts assembly 940 into an incision made in the perineum below the patient's scrotum and advances assembly 940 into the patient's tissue until the tip of trocar 838 reaches a target site proximal to the bladder neck of the bladder. Trocar 838 is then removed while maintaining the position of the tip of sheath 746 at the target site. The implantable device 1010, along with the retracted adjustable membrane element, is advanced through sheath 746 to a selected location using a push wire. In one embodiment, it is useful to ensure that the push wire is fully inserted into the adjustable restraining device. In one embodiment, the location of the front end of the implantable device 1010 can be confirmed, for example, by fluoroscopy, cystoscopy, or palpation. In one embodiment, the tip of the implantable device 1010 is positioned adjacent to the bladder neck.

[0032] In one embodiment, the sheath is pulled back approximately 2 centimeters so that the adjustable membrane element of the implantable device 1010 is clear of the sheath 746. This is in part to ensure that the balloon is not damaged during inflation. The implantable device 1010 can then be adjusted by piercing the septum of the rear port of the implantable device 1010 with a needle of a syringe, such as a 23 gauge non-coring needle of a syringe, and the adjustable membrane element can be partially inflated with approximately 1 milliliter of fluid, such as saline or isotonic contrast. In an embodiment using x-ray visualization or ultrasound, the physician can see the adjustable membrane element taking on a spherical shape. In one embodiment, the sheath 746 is completely removed from the patient before the adjustable membrane element is inflated.

[0033] In one embodiment, after the adjustable membrane element of the implantable device 1010 is partially inflated and the sheath 746 is completely removed from the patient, the passage is passed through the scrotum and the rear port of the implantable device 1010 is grasped with forceps and positioned toward the top of the scrotum. The incision can be closed, such as by suturing, over the conduit of the implantable device 1010.

[0034] 11 is a diagram, including a cutaway view, showing a pair of implantable devices 1010A and 1010B positioned in a patient to provide urethral coaptation, according to an embodiment of the present subject matter. In various embodiments, implantable devices 1010A and 1010B are each examples of implantable devices 1010. A physician can apply the same procedures described above to position each of implantable devices 1010A and 1010B, with the two devices positioned opposite each other relative to the patient's urethra.

[0035] In one embodiment, if possible, the physician confirms symmetric positioning of the adjustable membrane elements of implantable devices 1010A and 1010B relative to the urethra, such as by using x-ray visualization or ultrasound. The push wires may be removed from implantable devices 1010A and 1010B after the positioning of both devices is determined to be proper by the physician.

[0036] FIG. 12 is a diagram, including a cutaway view, illustrating the adjustment of urethral coaptation after a pair of implantable devices 1010A and 1010B are placed in a patient, according to an embodiment of the present subject matter. After placing them in the patient, the volume within the adjustable membrane elements of the implantable devices 1010A and 1010B can be adjusted percutaneously by penetrating the skin and the septum of the rear port of each of the implantable devices 1010A and 1010B with the needle of a syringe 120. After placement at the target site, the adjustable membrane elements are each inflated to a volume of 0.5-1.5 cc and observed by x-ray or ultrasound that they are in the correct position to coapt the urethra. Once this is confirmed, the adjustable membrane elements are left at a volume of 0.5-1.5 cc each, so that they remain securely in place but are not distorted by, for example, scar tissue or anatomical abnormalities. The adjustable membrane elements are left in this state for 4-6 weeks to allow tissue encapsulation to fix their position. The volume of each adjustable membrane element is then adjusted in increments of 0.5-1.0 cc every 4-6 weeks until suppression is achieved. Over time, further adjustments may be required to increase the volume of each adjustable membrane element to maintain suppression or decrease its volume to prevent urinary retention. In some instances, the physician will confirm the absence of urethral or bladder injury by cystoscopy, if necessary.

[0037] Although coaptation of the urethra in a male patient following a prostatectomy is shown in Figures 10-12 as an example, the present subject matter may be applied in various embodiments to coaptation of the urethra in any patient for urinary continence (e.g., in a female patient, or in a male patient following a transurethral resection of the prostate (TURP)). In various other embodiments, the present subject matter may be applied for coaptation of any body lumen, as necessary and feasible, taking into account factors including anatomy.

[0038] 13 is a diagram of an implantable device kit 1320 including an implantable device 1310, a sheath 1346, and optionally a push wire 1324, according to an embodiment of the present subject matter. The implantable device 1310, the sheath 1346, and optionally the push wire 1324 can be provided as a device kit 1320, which can also include other accessories (e.g., a surgical tool for inserting the sheath 1346 into tissue, such as one or more trocars for use with the sheath, as described above with reference to FIGS. 7-9). The implantable device 1310 can be used to join lumens in the body and can include an adjustable membrane element (also referred to as a balloon) 1312, an elongated conduit 1314, a rear port 1316, and a spiral 1350. The adjustable membrane element 1312 is configured to join a lumen and includes a continuous wall having an inner surface that defines a chamber. The rear port 1316 includes a conical strain relief 1325 made from a silicone or segmented polyurethane based elastomer bonded to the port base 1323. The conduit 1314 has a rear conduit end 1314A bonded to the rear port 1316 within the strain relief 1325, a front conduit end 1314B bonded to the adjustable membrane element 1312, a periphery connected and sealed to the adjustable membrane element 1312 near the front conduit end 1314B, and optionally (if a push wire 1324 is used, as described below) a push wire lumen 1317 extending longitudinally within the conduit 1314 from a lumen entrance 1317A near the rear conduit end 1314A to a lumen entrance 1317B at the front conduit end 1314B. The lumen entrance 1317A is sized to allow a portion of the push wire 1324 to enter. Pushwire lumen 1317 has a diameter to accommodate at least a portion of pushwire 1324 entering through lumen entrance 1317A. This diameter is suitable for the pushwire 1324 to move longitudinally within pushwire lumen 1317 by pushing the portion of pushwire 1324 outside of conduit 1314.

[0039] The rear port 1316 is coupled to the conduit 1314 by the conduit rear end 1314A in the strain relief 1325. The port base 1323 includes a cavity (not shown in FIG. 13) that is in fluid communication with the chamber of the adjustable membrane element 1312 through an inflation lumen (not shown in FIG. 13) in the conduit 1314, allowing the adjustable membrane element 1312 to expand by injecting fluid into the chamber and to contract by withdrawing fluid from the chamber. In some embodiments, the rear port 1316 is releasably coupled to the conduit rear end 1314A. In various embodiments, the exterior surface of the port base 1323 is covered by a layer made of the same material as the strain relief. This can be done by extending the strain relief 1325 to cover a substantial portion of the port base 1323 or the entire port base 1323.

[0040] In one embodiment, the rear port 1316 is substantially identical to the rear port 116 described above with reference to FIG. 2. The strain relief 1325 is formed by the tapered portion of the overmold 113. The port base 1323 is formed by the remainder of the overmold 113 (surrounding the port liner 111), the port liner 111, the elastomeric septum 118, and the cavity 116A. In other words, the strain relief 1325 includes the tapered portion of the overmold 113 of the rear port 116 as shown in FIG. 2, and the port base 1323 includes the remainder of the rear port 116 as shown in FIG. 2.

[0041] In various embodiments, implantable device 1310 is a multi-lumen (eg, dual lumen) implantable device that includes a pushwire lumen 1317 and an inflation lumen (not shown in FIG. 13) as separate lumens.

[0042] The helix 1350 is coupled to the conduit front end 1314B and functions as an anchoring mechanism to anchor the implantable device 1310 to tissue, thereby limiting displacement of the implantable device 1310 within tissue after implantation. In various embodiments, the implantable device 1310 can be anchored to tissue by rotating the helix 1350 into a portion of tissue using a rotational motion of the implantable device 1310 in a tightening direction (e.g., clockwise direction). In some embodiments, the implantable device 1310 can be released from tissue by disengaging the helix 1350 from the portion of tissue using a rotational motion of the implantable device 1310 in a loosening direction (e.g., counterclockwise direction), for example, when the implantable device 1310 needs to be repositioned within or removed from tissue. This can be done, for example, by introducing a push wire 1324 to rotate the implantable device 1310 or assist such rotation. In various embodiments, the implantable device 1310 can also be released from the tissue by disengaging the spiral 1350 from a portion of the tissue by pulling on the implantable device 1310 (a method called "pull-out release"), where the spiral 1350 is configured to avoid unacceptable levels of tissue damage and / or device breakage resulting from pulling. For example, the amount of pulling force required to pull the implantable device 1310 from tissue at the target site while the spiral 1350 remains engaged with the tissue (called "pull-out force") must be small enough to prevent the implantable device 1310 from breaking and leaving a portion behind in the patient's body. In one embodiment, the spiral 1350 is made of a bioresorbable material to facilitate pull-out release. After being placed in body tissue, the bioresorbable material (also called a biodegradable material) breaks down over time into one or more non-toxic substances that can be safely absorbed by the patient's body. The bioabsorbable spiral 1350 can anchor the implantable device 1310 until stabilized by tissue encapsulation following initial placement.Examples of bioabsorbable materials for the spiral 1350 include bioabsorbable polymers having suitable mechanical properties (e.g., strength and stiffness) for use in constructing the spiral, such as chitosan (e.g., derived from natural chitin from shellfish or mushrooms), and bioabsorbable metals, such as alloys of manganese, magnesium, iron, and / or zinc.

[0043] Implantable device 1310 may be a combination of spiral 1350 and implantable device 110 or any suitable implantable device selected from those described with reference to Figures 1-12, including but not limited to implantable devices including various combinations of features of implantable devices 110, 510, and 1010.

[0044] The sheath 1346 has an elongate cylindrical sheath body 1345 and a channel 1344 extending longitudinally within the sheath body 1345. The sheath body 1345A has a rear sheath end 1345A, a front sheath end 1345B, and slots 1348B-C extending longitudinally along at least a portion of the sheath body 1345. In the illustrated embodiment, the slots 1348B-C include a front slot portion 1348B and an intermediate slot portion 1348C. In other embodiments, the intermediate slot portion 1348C can extend to a point at or near the rear sheath end 1345A. The intermediate slot portion 1348C is sized to allow at least the adjustable membrane element 1312 (in its contracted state) and the conduit 1314 to be disposed within the channel 1344 of the sheath 1346. The slot front 1348B is sized to prevent the adjustable membrane element 1312 from exiting the channel 1344 as it is advanced therein, and to allow the sheath 1346 to be separated from the implantable device 1310 (e.g., by passing a portion of an elongated conduit 1314 through the slot front 1348B, which can be stretched to reduce its diameter if necessary), and then removed from the tissue after the implantable device 1310 has been positioned and anchored within the tissue. This is to reduce the likelihood that the edges of the slot front 1348B will cut into the inflation lumen in the conduit 1314. Another way (other than stretching the elongated conduit 1314) to protect the inflation lumen in the conduit 1314 from being cut by the edges of the slot front 1348B is to align the lumen entrance 1317A with the center of the slot front 1348B as a portion of the elongated conduit 1314 passes through the slot front 1348B. Yet another way to protect the inflation lumen in the conduit 1314 from being cut by the edges of the slot front 1348B is to pass a portion of a strain relief through the slot front 1348B, as will be further described below with reference to FIG. 19. In various embodiments, the sheath 1346 may be a sheath 946 modified to include a slot 1348 that is C-shaped across its diameter and has a varying width, the slot including a front portion and a middle portion that is wider than the front portion.

[0045] In one embodiment, the exterior surface of the rear port 1316 and the adjustable membrane element 1312 are sized (e.g., diameter) smaller than the interior size (e.g., diameter) of the channel 1344 to allow the implantable device 1310 to move longitudinally through the channel 1344 of the sheath 1346. In an alternative embodiment, the rear port 1316 is constructed from at least one material having sufficient flexibility to allow the size of the rear port 1316 in a relaxed state to be compressed to a sufficiently small size to allow the implantable device 1310 to move longitudinally through the channel 1344. In one embodiment, the conduit 1314 has sufficient stiffness to allow a force applied at the conduit rear end 1314A (e.g., through the rear port 1316) to move the implantable device 1310 at least partially through the channel 1344. In this embodiment, the push wire 1324 is optional and the implantable device kit 1320 can include only the implantable device 1310 and the sheath 1346. In one embodiment, the stiffness of the conduit 1314 is determined based on the type of material used in constructing its tubular elongate body. For example, the conduit 1314 may be made of polyurethane or silicone. A conduit 1314 made of polyurethane is substantially stiffer than a conduit 1314 made of silicone. Alternatively, support elements may be added to the tubular elongate body of the conduit 1314. For example, a metal coil may be placed longitudinally within the tubular elongate body to increase the stiffness of the tubular elongate body. In one embodiment, the conduit 1314 may have varying stiffness along its length provided by polyurethane having varying levels of stiffness.

[0046] In another embodiment, the push wire 1324 can be used to move the implantable device 1310 at least partially through the channel 1344 of the sheath 1346. The push wire 1324 has an elongate push wire body 1326 having a push wire trailing end 1326A and a push wire leading end 1326B. The push wire leading end 1326B can have any shape suitable for advancing the implantable device 1310 through the channel 1344 of the sheath 1346 and / or tissue. The elongate push wire body 1326 has a diameter suitable for moving longitudinally within the push wire lumen 1317 of the conduit 1314. Longitudinal movement of the push wire 1324 includes moving the push wire 1324 along its own longitudinal axis (which is also substantially parallel to the longitudinal axis of the conduit 1314).

[0047] The push wire 1324 and conduit 1314 may optionally be configured to allow the push wire to be used to rotate or assist in rotating the implantable device 1310. In some embodiments, as illustrated in FIG. 13, the pulse push wire front end 1326B is configured to include a driver 1327 and the conduit front end 1314B is configured to include a drive 1328 that is shaped to fit the driver 1327. For example, the driver 1327 may have a shape similar to the front end of a screwdriver and the drive 1328 may have a screw head drive shape that corresponds to the screwdriver shape (e.g., slot, Phillips, square, hex, or another standard or non-standard screw drive shape). In other embodiments where the push wire 1324 is not intended to be used to rotate the implantable device 1310, the driver 1327 and drive 1328 are not necessary and may not be included.

[0048] As used herein, terms including "substantial," "substantially," "approximately," "nearly," and the like, can refer to imperfections or inaccuracies resulting from practical factors including, but not limited to, errors in precision and manufacturing tolerances in manual operations. For example, the longitudinal axis of the push wire and the longitudinal axis of the push wire lumen of a conduit may be "substantially parallel" when the former (the push wire) is partially disposed within the latter (the push wire lumen) because they are not perfectly parallel due to, among other things, (1) errors in their manufacturing tolerances, (2) manually controlled movement of the push wire within the push wire lumen, and (3) a portion of the push wire not being within the push wire lumen. Such terms (such as "substantial," "substantially," "approximately," "approximately," and the like) can also refer to small deviations by design. For example, the push wire lumen may be "substantially parallel" to the longitudinal axis of the conduit, but a small portion of the push wire lumen adjacent the inlet (on the side of the conduit) deviates from being parallel to the longitudinal axis of the conduit as designed. In a multi-lumen implantable device, the pushwire lumen may be "substantially parallel" to the longitudinal axis of the conduit. A major portion of the pushwire lumen may be off-center within the conduit to allow space for the inflation lumen, but a front end portion of the pushwire lumen may deviate from being parallel to the longitudinal axis of the conduit and terminate in the center of the front end of the conduit.

[0049] 14 is a diagram of an implantable device kit 1420 including an implantable device 1410, a sheath 1346, and optionally a push wire 1324, according to an embodiment of the present subject matter. The implantable device 1410, the sheath 1346, and optionally the push wire 1324 can be provided as a device kit 1420, which can also include other accessories (e.g., a surgical tool for inserting the sheath 1346 into tissue, such as one or more trocars for use with the sheath, as described above with reference to FIGS. 7-9). The implantable device 1410 can be used to join lumens in the body and can include an adjustable membrane element (also referred to as a balloon) 1412, an elongated conduit 1414, a rear port 1416, and a fixation mechanism 1350. The adjustable membrane element 1412 is configured to join a lumen and includes a continuous wall having an inner surface defining a chamber. The rear port 1416 includes a conical strain relief 1425 (e.g., made from silicone or biostable segmented polyurethane) coupled to a port base 1423. The conduit 1414 has a rear conduit end 1414A coupled to the rear port 1416 within the strain relief 1425, a front conduit end 1414B coupled to the adjustable membrane element 1412, a periphery connected and sealed to the adjustable membrane element 1412 near the front conduit end 1414B, and an inflation lumen 1415 extending longitudinally within the conduit 1414. The inflation lumen 1415 has a rear lumen opening 1415A at the rear conduit end 1414A, a front lumen opening 1415B that is in fluid communication with the chamber of the adjustable membrane element 1412 and allows the adjustable membrane element 1412 to expand by injecting fluid into the chamber and to contract by withdrawing fluid from the chamber, and a front lumen end 1415C that allows the push wire 1324 to advance the implantable device 1410 within tissue and / or operate the fixation mechanism 1450. The front lumen end 1415C is a closed end that does not allow fluid to leak out of the lumen 1415.

[0050] The rear port 1416 is coupled to the conduit 1414 at the rear end 1414A within a strain relief 1425. The port base 1423 includes a cavity 1419 in fluid communication with the chamber of the adjustable membrane element 1412 through an inflation lumen 1415, allowing the adjustable membrane element 1412 to expand by injecting a fluid into the chamber and to contract by withdrawing a fluid from the chamber. The cavity 1419 is sealed by a septum 1418 that is elastic and self-sealing after being pierced, for example, by a hollow needle coupled to a syringe for injecting and withdrawing fluid. In some embodiments, the rear port 1416 is releasably coupled to the rear end 1414A of the conduit. In various embodiments, the exterior surface of the port base 1423 is covered by a lining made of a material such as a silicone-based or polyurethane-based copolymer. For example, the lining may include a thin layer formed by extending the strain relief 1425 over a substantial portion of the port base 1423 or over the entire port base 1423 .

[0051] In one embodiment, the exterior surface of the rear port 1416 and the adjustable membrane element 1412 are sized (e.g., diameter) smaller than the interior size (e.g., diameter) of the channel 1344 to allow the implantable device 1310 to move longitudinally through the channel 1344 of the sheath 1346. In an alternative embodiment, the rear port 1416 is constructed from at least one material having sufficient flexibility to allow the size of the rear port 1416 in a relaxed state to be compressed to a sufficiently small size to allow the implantable device 1410 to move longitudinally through the channel 1344. In one embodiment, the conduit 1414 has sufficient stiffness to allow a force applied at the conduit rear end 1414A (e.g., through the rear port 1316) to move the implantable device 1410 at least partially through the channel 1344. In this embodiment, the push wire 1324 is optional and the implantable device kit 1420 can include only the implantable device 1410 and the sheath 1346. In one embodiment, the stiffness of the conduit 1414 is determined based on the type of material used in constructing its tubular elongate body. For example, the conduit 1414 may be made of polyurethane or silicone. A conduit 1414 made of polyurethane is substantially stiffer than a conduit 1414 made of silicone. Alternatively, support elements may be added to the tubular elongate body of the conduit 1414. For example, a metal coil may be placed longitudinally within the tubular elongate body to increase the stiffness of the tubular elongate body. In one embodiment, the conduit 1414 may have varying stiffness along its length provided by polyurethane having varying levels of stiffness.

[0052] In another embodiment, the push wire 1324 can be used to move the implantable device 1310 at least partially through the channel 1344 of the sheath 1346. The implantable device 1410 can be a single lumen implantable device having an inflation lumen 1415 that also functions as the push wire lumen. The inflation lumen 1415 can meet the requirements of the push wire lumen 1317 as described above, with the push wire lumen entrance being the inflation lumen rear end 1415A. The push wire 1324 can enter the inflation lumen 1415 by piercing the septum 1418.

[0053] The helix 1350 is coupled to the conduit front end 1414B and functions as a fixation mechanism to anchor the implantable device 1410 to tissue, thereby limiting displacement of the implantable device 1410 within tissue after implantation. In various embodiments, the implantable device 1410 can be fixed to tissue by extending the helix 1350 into a portion of tissue using rotational motion of the implantable device 1410 in a tightening direction (e.g., clockwise direction). In some embodiments, the implantable device 1410 can be released from tissue by disengaging the helix 1350 from the portion of tissue using rotational motion of the implantable device 1410 in a loosening direction (e.g., counterclockwise direction), for example, when the implantable device 1410 needs to be repositioned within or removed from tissue. This can be done, for example, by introducing a push wire 1324 to rotate the implantable device 1410 or to assist in such rotation. In various embodiments, the implantable device 1410 can also be released from the tissue by disengaging the spiral 1350 from a portion of the tissue by pulling on the implantable device 1410 (i.e., pull-out release), where the spiral 1350 is configured to avoid unacceptable levels of tissue damage and / or device breakage resulting from pulling. For example, the magnitude of the pull-out force should be small enough to prevent the implantable device 1410 from breaking off and leaving a portion within the patient's body.

[0054] The push wire 1324 and conduit 1414 may optionally be configured to allow the push wire to be used to rotate or assist in rotating the implantable device 1410. In some embodiments, as illustrated in FIG. 14, the pulse push wire front end 1326B is configured to include a driver 1327 and the conduit front end 1414B is configured to include a drive 1428 that is shaped to fit the driver 1327. For example, the driver 1327 may have a shape similar to the front end of a screwdriver and the drive 1428 may have a screw head drive shape that corresponds to the screwdriver shape (e.g., slot, Phillips, square, hex, or another standard or non-standard screw drive shape). In other embodiments where the push wire 1324 is not intended to be used to rotate the implantable device 1310, the driver 1327 and drive 1428 are not necessary and may not be included.

[0055] Implantable device 1410 may be a combination of spiral 1350 and a suitable implantable device selected from the implantable devices described with reference to Figures 1-12, including, but not limited to, implantable device 510 or implantable devices including various combinations of features of implantable devices 110, 510, and 1010.

[0056] In various embodiments, implantable device 1310 and implantable device 1410 can have a substantially similar size. For example, adjustable membrane element 1312 and adjustable membrane element 1412 can have a substantially similar size, elongated conduit 1314 and elongated conduit 1414 can have a substantially similar size, and rear port 1316 and rear port 1416 can have a substantially similar size.

[0057] 15-19 are diagrams of a method for positioning an implantable device 1510 in a patient's tissue using a sheath 1346, according to an embodiment of the present subject matter. The implantable device 1510 can be used to join lumens within the body and can include an adjustable membrane element (also referred to as a balloon) 1512, an elongated conduit 1514, a rear port 1516, and a spiral 1350. Examples of implantable devices 1510 include implantable device 1310 (having adjustable membrane element 1512, elongated conduit 1514, rear port 1516 corresponding to adjustable membrane element 1312, elongated conduit 1314, rear port 1316, respectively) and implantable device 1410 (having adjustable membrane element 1512, elongated conduit 1514, rear port 1516 corresponding to adjustable membrane element 1412, elongated conduit 1414, rear port 1416, respectively). The embodiments shown in Figures 15-19 are described by way of example and not by way of limitation to illustrate how implantable device 1510 may be positioned within and secured to tissue. For example, while a push wire is not used in the illustrated embodiment, a push wire can be used in various embodiments where the implantable device 1510 is configured to receive a portion of the push wire to advance the implantable device 1510 within the sheath 1346 and / or tissue channel 1344. During the method, the portion of the implantable device 1510 that has entered the patient and the sheath 1346 can be viewed using medical imaging techniques such as fluoroscopy or ultrasound.

[0058] 15 shows that the implantable device 1510 is partially positioned in the channel 1344 of the sheath 1346 through the slot middle portion 1348C after the sheath has been positioned to allow the adjustable membrane element 1512 to be positioned at a target site in a patient. The sheath 1346 has a rear sheath portion including a rear slot portion 1348A, a front sheath portion including a front slot end 1348B, and a middle sheath portion including a slot middle portion 1348C. The slot middle portion 1348C is sized to allow the adjustable membrane element 1512 and the elongated conduit 1514 to be positioned in the channel 1344 when the adjustable membrane element 1512 is substantially retracted. The slot front portion 1348B is substantially narrower than the slot middle portion 1348C to form a substantially closed portion of the channel 1344 at the sheath front and guide the substantially retracted adjustable membrane element 1512 to the sheath front. The narrower slot front 1348B also prevents the adjustable membrane element 1512 from exiting the channel 1344 when it is advanced within the channel 1344 at the sheath front.

[0059] 16 shows that the adjustable membrane element 1512 of the implantable device 1510 has been advanced into the front of the sheath (including the slotted front 1348) such that the spiral 1350 extends from the sheath 1346, as may be seen using fluoroscopy or ultrasound. The adjustable membrane element 1512 is expanded to such an extent that it fills a portion of the channel 1344 at the front of the sheath and grips the inside of the sheath, so that when the sheath 1346 is rotated, it rotates with the sheath 1346, thus rotating the spiral 1350 attached to the conduit 114 or 514 into the tissue for fixation. This requires a relatively small volume (e.g., on the order of 0.1 cc). Over-inflation at this point can cause a portion of the adjustable membrane element 1512 to protrude (or bulge out) from the sheath 1346 through the slot front 1348B, a scenario that is described further below with reference to Figures 20 and 21.

[0060] Due to the high sensitivity of the adjustable membrane element 1512 volume to resist rotation (i.e., slippage) of the adjustable membrane element 1512 relative to the sheath due to the substantially limited protrusion through the slot front 1348B, the inflation of the adjustable membrane element 1512 at this point in the 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 element 1512. In another embodiment, the adjustable membrane element 1512 can be inflated to a specific pressure. This can be done, for example, using a pressure gauge on the syringe or a T-connector coupled between the syringe and the adjustable membrane element 1512. By controlling pressure rather than volume, the method can be performed using a single syringe to inflate the adjustable membrane element 1512 first for rotational stability and later for coaptation of the body lumen. In various embodiments, if desired, this volume sensitivity can be reduced with a looser fit by either increasing the diameter of the sheath 1346 and / or decreasing the diameter of the adjustable membrane element 1512 (in its contracted state).

[0061] In various embodiments, the adjustable membrane element 1512 can be configured for desired characteristics related to its protrusion through the slot. In various embodiments, the rotational stability (i.e., slip resistance) of the adjustable membrane element 1512 within the sheath 1346 can be increased by incorporating a gripping mechanism in a portion of the channel 1344 in the front of the sheath (with the front slot 1348B) to prevent the adjustable membrane element 1512 from slipping within the front of the sheath. Examples of such mechanisms include textures and shallow longitudinal grooves or ridges on the surface of a portion of the channel 1344 (i.e., the inner surface of the front of the sheath).

[0062] After the adjustable membrane element 1512 is secured to the front of the sheath to prevent the helix 1350 from rotating relative to the sheath 1346 with the helix 1350 extending into tissue at the target site, the sheath 1346 is rotated in a clamping direction to rotate the helix 1350 into the tissue. The number of turns required to provide a desired level of fixation can be determined using testing and experience for each of the different types of tissue (e.g., scar, muscle, or fat) to which the implantable device 1510 may be anchored. The desired level of fixation can provide sufficient fixation to the implantable device 1510 to prevent the adjustable membrane element 1512 from migrating until encapsulation occurs. In various embodiments, the desired level of fixation also allows for removal of the implantable device 1510 by pull-out release (without actively disengaging the helix 1350 from the tissue) without causing tissue damage and / or device failure.

[0063] 17 shows that after the spiral 1350 is rotated into the tissue, the sheath 1346 is withdrawn to allow expansion of the adjustable membrane element 1512. The adjustable membrane element 1512 is retracted to allow withdrawal of the sheath 1346 before it is expanded into the tissue.

[0064] FIG. 18 shows the adjustable membrane element 1512 being inflated (e.g., to a volume of 2-3 cc) at the tissue site. Proper positioning of the adjustable membrane element 1512 can be confirmed by observing the coaptation (e.g., flattening) of the body lumen (e.g., urethra) using fluoroscopy or endoscopy. If the position is adjusted, the adjustable membrane element 1512 can be deflated, moved back into the front of the sheath, and inflated to re-anchor the adjustable membrane element 1512 to the front of the sheath and prevent it from rotating relative to the sheath 1346, and the helix 1350 can be actively disengaged from the tissue by rotating the sheath 1346 in the loosening direction. The steps described above with reference to FIGS. 16-18 can be repeated until the positioning of the adjustable membrane element 1512 is satisfactory. Alternatively, the steps described above with reference to FIGS. 15-18 can be partially performed by skipping rotations of the helix 1350 until proper positioning of the adjustable membrane element 1512 is confirmed. The adjustable membrane element 1512 can then be retracted, the sheath 1346 advanced so that the front of the sheath is over the adjustable membrane element 1512, and the steps described above with reference to Figures 16-18 performed to anchor the implantable device 1510 to tissue at the target site.

[0065] 19 shows that after the implantable device 1510 is anchored in tissue at the target site and proper positioning of the adjustable membrane element 1512 is confirmed, the sheath 1346 is withdrawn until the rear port 1516 reaches the transition between the middle slot portion 1348C and the front slot portion 1348B. As shown in FIG. 19, the rear port 1516 has a conical strain relief at the transition between the rear port 1516 and the conduit 1514. In one embodiment, the transition between the middle slot portion 1348C and the front slot portion 1348B engages the conical strain relief of the port 1516 to prevent damage to the conduit 1514 while the port 1516 is being pushed and / or while the sheath 1346 is being pulled to separate the implantable device 1510 from the sheath 1346. The strain relief can have sufficient elastic bulk to resist any significant damage. In another embodiment, the conduit 1514 and sheath 1346 are configured to allow the conduit 1514 to be stretched to have a diameter smaller than the width of the slot front 1348B. The sheath 1346 can then be separated from the implantable device 1510 by threading the stretched conduit 1514 through the slot front 1348B. In another embodiment where the slot front 1348B is replaced by a slit or very narrow slot, the slit or narrow slot can be opened using a tool (e.g., internal snap ring pliers) to allow the sheath 1346 to be separated from the implantable device 1510.

[0066] After the implantable device 1510 is positioned and secured to tissue at the target site and the sheath 1346 is separated from the implantable device 1510, the implantable device may need to be removed from the patient for repositioning or replacement of the device, for example, when the patient's condition changes and / or a more suitable device is available. In one embodiment, the sheath 1346 may be inserted into the patient and engaged with the implantable device 1510, for example, by placing the exposed portion of the conduit 1514 through the slot front 1348B and advancing the sheath 1346 until the adjustable membrane element 1512 (which has been contracted) is within the sheath front. The adjustable membrane element 1512 is then expanded to a degree that allows the helix 1350 to be actively disengaged from the tissue by rotating the sheath 1346 in a loosening direction. In another embodiment, the implantable device 1510 is removed using a pull-out release. In one embodiment, the spiral 1350 is made from a bioabsorbable material, as described above, which makes it easier and safer to remove the implantable device 1510 by pull-out release (or any pulling method to remove the implantable device 1510 for repositioning) after the spiral 1350 has substantially degraded.

[0067] 20-21 are diagrams illustrating scenarios and device features associated with the scenarios during the implementation of the method of FIGS. 15-19, according to embodiments of the present subject matter. FIG. 20 illustrates an adjustable membrane element 1512 of an implantable device 1510 protruding from a portion of a slot (e.g., slot front 1348B) of a sheath 1346. FIG. 21 is a longitudinal cross-sectional view of the adjustable membrane element 1512 from the slot front 1348B of the sheath 1346. As discussed above with reference to FIG. 16, overinflation of the adjustable membrane element 1512 can cause a portion of it to protrude from the sheath 1346 through the slot front 1348B, thereby exposing the adjustable membrane element 1512 to a risk of injury from the edge of the slot front 1348B. Such protrusion can be observed, for example, using fluoroscopy. On the other hand, the limited protrusion of the adjustable membrane element 1512 from the slot front 1348B can add rotational stability (i.e., slip resistance) of the adjustable membrane element 1512 in the sheath 1346. In this case, special care should be taken to ensure that the edges of the slot are smooth and rounded. In various embodiments, as shown in FIG. 21, the slot front 1348B has two slot edges, each of which includes a rounded inner edge 1349 with an inner radius (directly bonded to the inner surface of the sheath 1346) and a rounded outer edge 1350 with an outer radius (directly bonded to the outer surface of the sheath 1346). The inner and outer radii can be experimentally determined to prevent damage to the adjustable membrane element 1512 caused by the protrusion of the adjustable membrane element 1512 from the sheath 1346 through the slot front 1348B, with the inner radius being greater than the outer radius. In various embodiments, the entire slot 1348 can have such inner and outer edges. Additionally, the edges of the slots 1348 or the entire elongated cylindrical sheath body 1345 may be treated with a lubricious coating, such as parylene, to further prevent damage to the adjustable membrane element 1512.

[0068] In various embodiments, the volume of the adjustable membrane element 1512 during each step in performing the methods shown in FIGS. 15-19 can be empirically determined to ensure that each step can be performed as intended. Various factors for determining the appropriate volume for each step include, but are not limited to, the torque required to rotate the implantable device 1510 together with the sheath 1346, the amount of protrusion of the adjustable membrane element 1512 from the sheath 1346 through the slot front portion 1348B that is allowed and / or desired, the characteristics of the inner surface of the sheath 1346, and / or the durability of the adjustable membrane element 1512.

[0069] Some non-limiting examples (Examples 1-21) of the present subject matter are provided below. In Example 1, an implantable device configured to be positioned within a living tissue for joining body lumens is provided. The implantable device may include an adjustable membrane element, a long conduit, a rear port, and a helix. The adjustable membrane element may be configured to join body lumens and may include a continuous wall having an inner surface defining a chamber. The long 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 with the adjustable membrane element at or near the conduit front end. The one or more conduit lumens may at least 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 long conduit at the conduit rear end and may 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 may be configured to secure the implantable device to the tissue by rotating the entire implantable device in a tightening direction.

[0070] 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 the conduit rear end is connected to the long conduit with the conduit rear end within the strain relief.

[0071] 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 a biostable segmented polyurethane.

[0072] In Example 4, the subject matter of any one or any combination of Examples 1-3 may optionally be configured such that the spiral is constructed from a bioabsorbable material. In Example 5, an implantable device kit for controllably joining a body lumen in tissue at 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 elongated conduit, a rear port, and a spiral. The adjustable membrane element may be configured to join the body lumen and include a continuous wall having an inner surface defining a chamber. The elongated conduit may include a conduit circumferential surface, a rear conduit end, a front conduit end, and one or more conduit lumens. The conduit circumferential surface may be connected to the adjustable membrane element at or near the front conduit end and sealed. The one or more conduit lumens may include an inflation lumen having a first opening at the rear conduit end, a second opening in fluid communication with the chamber, and a closed end at or near the front conduit end. The rear port may include a cavity connected to the rear conduit end and in fluid communication with the first opening of the inflation lumen. The spiral may be coupled to the conduit front end and configured to anchor the implantable device to tissue. The sheath may be configured to house a portion of the implantable device including the adjustable membrane element and be used to guide the implantable device to a target site and rotate the implantable device when the portion of the implantable device is disposed within the sheath with the adjustable membrane element partially expanded.

[0073] In Example 6, the subject matter of Example 5 may be configured to optionally further include a push wire, and the one or more conduit lumens may further include a push wire lumen having an opening on the elongate conduit and a closed end at or near a forward end of the conduit, the opening allowing the push wire to enter the push wire lumen and the closed end configured to allow the implantable device to be pushed forward through the sheath by applying an advancing force to the push wire.

[0074] 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 elongate body and a longitudinal slot. The elongate body includes a rear sheath section, a front sheath section, and a middle sheath section coupled between the rear sheath section and the front sheath section. The longitudinal slot includes at least a middle slot section extending on the middle sheath section and a front slot section extending on the front sheath section. The middle slot section is configured to allow placement of a portion of the implantable device within the sheath. The front slot section is configured to allow the implantable device to rotate with the sheath when the adjustable membrane element is substantially disposed within the sheath and partially inflated, and is configured to allow the sheath to be separated from the implantable device.

[0075] In Example 8, the subject matter of Example 7 may optionally be configured such that the front portion of the sheath includes an inner surface that includes one or more gripping features. In Example 9, the subject matter of Example 8 may optionally be configured such that one or more gripping features include longitudinal grooves or ridges.

[0076] In Example 10, the subject matter of any one or any combination of Examples 7-9 may optionally include a rear port of the implantable device that includes a strain relief and a port base coupled to the strain relief and is configured to be connected to a long conduit with the rear end of the conduit within the strain relief, and at least a portion of the strain relief configured to pass through a front slot of the sheath when the sheath is separated from the implantable device.

[0077] 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 inner surface and an outer surface, the longitudinal slot is formed by two slot edges each bonded between the inner surface and the outer surface, the two slot edges each including an inner edge directly bonded to the inner surface and having an inner radius, and an outer edge directly bonded to the outer surface and having an outer radius, and the inner radius is greater than the outer radius, at least for a front portion of the slot.

[0078] In Example 12, the subject matter of any one or any combination of Examples 5-11 may optionally be configured such that the implantable device includes one or more elastic portions, each constructed from a biostable segmented polyurethane.

[0079] In Example 13, a method is provided for joining a body lumen in tissue at a target site in a living body. The method may include providing an implantable device. The implantable device may include an adjustable membrane element, an elongated conduit, a rear port, and a spiral. The adjustable membrane element may be configured to join a body lumen and may include a continuous wall having an inner surface defining a chamber. The elongated conduit may include a conduit circumferential surface, a rear conduit end, a front conduit end, and one or more conduit lumens. The conduit circumferential surface may be connected to the adjustable membrane element and sealed at or near the front conduit end. The one or more conduit lumens may include an inflation lumen having a first opening at the rear conduit end, a second opening in fluid communication with the chamber, and a closed end at or near the front conduit end. The rear port may include a cavity connected to the rear conduit end and in fluid communication with the first opening of the inflation lumen. The spiral may be coupled to the front conduit end. The method may further include, once the implantable device is positioned at the target site, rotating the implantable device in a tightening direction to rotate the helix into tissue.

[0080] In Example 14, the subject matter of Example 13 can optionally further include disengaging the spiral from the tissue by pulling the implantable device. In Example 15, the subject matter of providing an implantable device as in any one or any combination of Examples 13 and 14 may optionally include constructing the spiral using a bioabsorbable material.

[0081] In Example 16, the subject matter of any one or any combination of Examples 13-15 may optionally further include providing a sheath and disposing a portion of the implantable device including the adjustable membrane element within the sheath with the spiral extending from a front end of the sheath, such that rotating the implantable device includes partially expanding the adjustable membrane element such that the implantable device rotates with the sheath and rotating the sheath.

[0082] In Example 17, the subject matter of providing a sheath as seen in Example 16 may optionally include providing a sheath including an elongate body and a longitudinal slot. The elongate body includes a rear sheath section, a front sheath section, and a mid-sheath section coupled between the rear sheath section and the front sheath section. The longitudinal slot includes a mid-slot section extending into the mid-sheath section and a front slot section extending into the front sheath section. The mid-slot section is wider than the front slot section and sized to allow placement of a portion of an implantable device within the sheath. The front slot section is sized to allow the sheath to be separated from the implantable device by passing a portion of an elongate conduit through the front slot section.

[0083] In Example 18, the subject matter of providing a sheath as in any one or any combination of Examples 16 and 17 may optionally include providing a disposable sheath.

[0084] In Example 19, the subject matter of partially expanding the adjustable membrane element so that the implantable device rotates with the sheath as found in any one or any combination of Examples 16-18 may optionally include injecting fluid into a cavity of a rear port of the implantable device and controlling the volume of fluid injected into the cavity to cause a portion of the adjustable membrane element of the implantable device to protrude through the front of the slot when the adjustable membrane element is positioned in front of the sheath.

[0085] In Example 20, the subject matter of partially expanding an adjustable membrane element such that the implantable device rotates with the sheath, as in any one or any combination of Examples 16-18, may optionally include injecting fluid into a cavity in the rear port of the implantable device and controlling the pressure of the fluid injected into the cavity.

[0086] In Example 21, the subject matter of rotating the implantable device in a tightening direction to rotate the spiral into tissue as in any one or any combination of Examples 13-20 may optionally include controlling the amount of rotation based on the tissue type.

[0087] This application is intended to cover any adaptations or variations of the present subject matter. It is to be understood that the above detailed description is illustrative, and not restrictive. Other embodiments will be apparent to those skilled 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.

Claims

1. 1. An implantable device configured to be positioned within tissue of a living body for joining a body lumen of the living body, the implantable device comprising: an adjustable membrane element configured to join the body lumen and including a continuous wall having an inner surface defining a chamber; an elongate conduit including a circumferential conduit surface, a rear conduit end, a front conduit end, and one or more conduit lumens, the circumferential conduit surface being connected to and sealed to the adjustable membrane element at or near the front conduit end, the one or more conduit lumens including at least an inflation lumen having a first opening at the rear conduit end, a second opening in fluid communication with the chamber, and a closed end at or near the front conduit end; a rear port connected to the elongate conduit at a rear end of the conduit and including a cavity in fluid communication with the first opening of the inflation lumen; a helix 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.

2. 2. The implantable device of claim 1, wherein the rear port comprises a strain relief and a port base coupled to the strain relief, and is connected to the elongated conduit with the conduit rear end within the strain relief.

3. 3. The implantable device of claim 1 or 2, comprising one or more elastic portions each constructed of a biostable segmented polyurethane.

4. The implantable device of claim 1 or 2, wherein the spiral is constructed from a bioabsorbable material.

5. 1. An implantable device kit for controllable joining of a body lumen in tissue at a target site in vivo, comprising:

1. An implantable device comprising: an adjustable membrane element configured to join the body lumen and including a continuous wall having an inner surface defining a chamber; an elongate conduit including a circumferential conduit surface, a rear conduit end, a front conduit end, and one or more conduit lumens, the circumferential conduit surface being connected to and sealed to the adjustable membrane element at or near the front conduit end, the one or more conduit lumens including an inflation lumen having a first opening at the rear conduit end, a second opening in fluid communication with the chamber, and a closed end at or near the front conduit end; a rear port connected to the rear end of the conduit and including a cavity in fluid communication with the first opening of the inflation lumen; a helix coupled to the conduit front end and configured to anchor the implantable device to the tissue; an implantable device kit comprising: a sheath configured to house a portion of the implantable device including the adjustable membrane element, the sheath configured to guide the implantable device to the target site and configured to be used to rotate the implantable device when a portion of the implantable device is positioned within the sheath with the adjustable membrane element partially expanded.

6. 6. The implantable device kit of claim 5, further comprising a push wire, and the one or more conduit lumens further include a push wire lumen having an opening on the elongate conduit and a closed end at or near a forward end of the conduit, the opening allowing the push wire to enter the push wire lumen and the closed end allowing the implantable device to be pushed forward through the sheath by applying a forward force to the push wire.

7. The sheath is an elongated body including a rear sheath section, a front sheath section, and a middle sheath section coupled between the rear sheath section and the front sheath section; 7. The implantable device kit of claim 5 or 6, comprising a longitudinal slot including at least a middle slot portion extending on the sheath middle portion and a front slot portion extending on the sheath front portion, the middle slot portion configured to allow placement of a portion of an implantable device within the sheath, the front slot portion configured to allow the implantable device to rotate with the sheath when the adjustable membrane element is substantially positioned within the sheath and partially inflated, and configured to allow the sheath to be separated from the implantable device.

8. The implantable device kit of claim 7 , wherein the front portion of the sheath comprises an inner surface including one or more gripping features.

9. The implantable device kit of claim 8 , wherein the one or more gripping features comprise longitudinal grooves or ridges.

10. 8. The implantable device kit of claim 7, wherein the rear port of the implantable device comprises a strain relief and a port base coupled to the strain relief, the rear end of the conduit is connected to the elongate conduit with the rear end of the conduit within the strain relief, and at least a portion of the strain relief is configured to pass through the front slot of the sheath when the sheath is separated from the implantable device.

11. 8. The implantable device kit of claim 7, wherein the sheath has an inner surface and an outer surface, the longitudinal slot is formed by two slot edges respectively connected between the inner surface and the outer surface, the two slot edges each having an inner edge directly connected to the inner surface and having an inner radius, and an outer edge directly connected to the outer surface and having an outer radius, the inner radius being greater than the outer radius, at least for the front of the slot.

12. 7. The implantable device kit of claim 5 or 6, wherein the implantable device comprises one or more elastic portions, each constructed of a biostable segmented polyurethane.

Images