Fixation of implantable devices for continence

Abstract

A method and apparatus for inhibiting migration of a device implanted in a patient for treating urinary incontinence is provided. The implantable device (1310) includes a conduit (1314), an adjustable membrane element (1312) coupled to the conduit near its forward end for controllable joining of a body lumen, such as joining of the urethra for treating urinary incontinence, and a fixation mechanism (1350) located at or near the forward end of the conduit. In various embodiments, the fixation mechanism can utilize movement of a push wire (1324) to anchor the implantable device to tissue. Optionally, the fixation mechanism can also utilize separate movement of the push wire to release the implantable device from tissue, allowing for repositioning or removal of the implantable device.

Description

[Technical Field]

[0001] This document relates to implantable medical devices, and more particularly to methods and devices for inhibiting migration of a urinary incontinence treatment device implanted in a patient. [Background technology]

[0002] An implantable device for treating urinary incontinence includes an adjustable membrane element, such as a balloon, connected to a posterior port by a conduit. The implantable device is implanted in a patient through minimally invasive surgery, with the adjustable membrane element positioned near the patient's urethra and the posterior port positioned under the patient's skin. The adjustable membrane element can be adjusted during and after surgery by percutaneously injecting or withdrawing fluid from the posterior port using a needle. In an exemplary treatment, two such implantable devices are placed in a patient, and the two adjustable membrane elements provide pressure and support to the patient's bladder neck to prevent unintentional leakage, such as from stress urinary incontinence (e.g., leakage during sneezing, coughing, or physical activity) or neurogenic bladder (e.g., leakage due to spinal cord injury). The effectiveness of such treatment depends on accurately positioning the adjustable membrane element at the patient's desired location, adjusting the adjustable membrane element after placement, and maintaining the position of the adjustable membrane element over time. Summary of the Invention [Problem to be solved by the invention]

[0003] SUMMARY OF THE INVENTION It is an object of the present invention to provide a method and apparatus for inhibiting migration of a urinary incontinence treatment device implanted in a patient. [Means for solving the problem]

[0004] The implantable device includes a conduit, an adjustable membrane element coupled to the conduit near its forward end for controllable joining of a body lumen, such as joining of the urethra for treating urinary incontinence, and an anchoring mechanism located at or near the forward end of the conduit. In various embodiments, the anchoring mechanism can utilize movement of a push wire to anchor the implantable device to tissue. Optionally, the anchoring mechanism can also utilize another movement of the push wire to release the implantable device from tissue, allowing for repositioning or removal of the implantable device.

[0005] In one exemplary embodiment, an implantable device is configured to be positioned within biological tissue using a push wire to join a body lumen of a living body. The implantable device includes an adjustable membrane element, an elongate conduit, and an anchoring mechanism. The adjustable membrane element includes a continuous wall having an inner surface defining a chamber. The elongate conduit includes a conduit outer periphery, a conduit rear end, a conduit front end, and a push wire lumen. The conduit outer periphery is connected to and adheres to the adjustable membrane element at or near the conduit front end. The push wire lumen extends longitudinally within the conduit and has an entrance for receiving a portion of the push wire and a diameter suitable for accommodating the received portion of the push wire. The anchoring mechanism is coupled to the conduit front end and configured to utilize movement of the push wire to anchor the implantable device to tissue.

[0006] In another exemplary embodiment, a method for joining a body lumen within living tissue is provided. The method includes providing an implantable device and operating a fixation mechanism of the implantable device with a push wire. The implantable device includes an adjustable membrane element, an elongate conduit, and a fixation mechanism. The adjustable membrane element has a continuous wall having an inner surface defining a chamber. The elongate conduit has a conduit outer periphery, a conduit rear end, a conduit front end, and a push wire lumen. The conduit outer periphery is connected to and adheres to the adjustable membrane element at or near the conduit front end. The push wire lumen extends longitudinally within the conduit and has an entrance for receiving a portion of the push wire and a diameter suitable for accommodating the received portion of the push wire. The fixation mechanism is configured to secure the implantable device to tissue.

[0007] 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. More detail about the present subject matter is found in the detailed description and claims. The scope of the present invention is defined by the claims and their legal equivalents. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view illustrating an implantable device and a syringe source for supplying flowable material to an adjustable membrane element of the implantable device, according to one embodiment of the present subject matter. [Figure 2] 2 is a longitudinal cross-sectional view of the implantable device shown in FIG. 1 according to one embodiment of the present subject matter. [Figure 3] 3 is a cross-sectional view of FIG. 2 taken along line 3-3, according to one embodiment of the present subject matter. [Figure 4] 1A and 1B illustrate a guide probe inserted into body tissue to an implantation location near a patient's body lumen prior to insertion of an implantable device, according to one embodiment of the present subject matter. [Figure 5] 1A-1C show an implantable device partially advanced to a desired position with the adjustable membrane element positioned over the guide probe in a contracted state, according to one embodiment of the present subject matter. [Figure 6]FIG. 1 illustrates an implantable device in an expanded state at a desired location within a patient's body tissue for moving the body tissue toward the body lumen to provide adjustable restriction of the body lumen, according to one embodiment of the present subject matter. [Figure 7] 7 is a cross-sectional view of FIG. 6 taken along line 7-7, according to one embodiment of the present subject matter. [Figure 8] FIG. 1 illustrates an implantable device after insertion with the posterior port located under the patient's skin, according to one embodiment of the present subject matter. [Figure 9] 1 is a schematic diagram illustrating another implantable device according to an embodiment of the present subject matter. [Figure 10] 1 is a schematic diagram illustrating another implantable device according to an embodiment of the present subject matter. [Figure 11] FIG. 1 is a top view showing the approximate target placement site of an implantable device for improving urethral coaptation, according to one embodiment of the present subject matter. [Figure 12] 1 is a diagram of an implantation region along the length of the urethra showing approximate target placement sites for an implantable device for improving urethral coaptation, according to one embodiment of the present subject matter. [Figure 13] 1 illustrates an implantable device and a push wire according to one embodiment of the present subject matter. [Figure 14] 10 illustrates another implantable device and push wire according to one embodiment of the present subject matter. [Figure 15] 10A-10C illustrate another push wire according to an embodiment of the present subject matter. [Figure 16] 10A-10C illustrate yet another push wire according to an embodiment of the present subject matter. [Figure 17A] FIG. 10 is a view of the front end of an implantable device for use with a push wire, including a fixation mechanism with a spring, with the spring shown in an extended position. [Figure 17B] FIG. 10 is a view of the front end of an implantable device for use with a push wire, including a fixation mechanism with a spring, with the spring shown in a rest position. [Figure 18A] 17A and 17B, showing a wire having a semicircular cross section, according to an embodiment of the present subject matter. FIG. [Figure 18B] 17C is a diagram of a wire used to make the spring of FIGS. 17A and 17B, showing a wire with a rectangular cross section and a recess, according to an embodiment of the present subject matter. FIG. [Figure 18C] 17C is a diagram of a wire used to make the spring of FIGS. 17A and 17B, showing a wire with a semicircular cross section and a protrusion, according to an embodiment of the present subject matter. FIG. [Figure 19] 18 illustrates the front end of the implantable device of FIG. 17 used with an alternative push wire, according to one embodiment of the present subject matter. [Figure 20A] FIG. 1 is a side cross-sectional view of the front end of an implantable device for use with a push wire, including a fixation mechanism with clamps, according to one embodiment of the present subject matter, showing the clamps in an open position. [Figure 20B] FIG. 1 is a side cross-sectional view of the front end of an implantable device for use with a push wire, including a fixation mechanism with clamps, according to one embodiment of the present subject matter, showing the clamps in a closed position. [Figure 20C] FIG. 1 is an end view of the front end of an implantable device for use with a push wire, including a fixation mechanism with clamps, according to one embodiment of the present subject matter, showing the clamps in a closed position. [Figure 21] 1A-1C illustrate the front end of an implantable device for use with a push wire having a fixation mechanism with a helix, according to one embodiment of the present subject matter. [Figure 22A] 22 is a top view of an example of the front end of an implantable device for use with the push wire of FIG. 21, where the implantable device is a single lumen device or a multi-lumen device, according to one embodiment of the present subject matter. FIG. [Figure 22B] FIG. 22 is a side view of an example of the front end of an implantable device for use with the push wire of FIG. 21, where the implantable device is a multi-lumen device, according to one embodiment of the present subject matter. [Figure 23] 22A-22C illustrate another example of a front end of an implantable device for use with the push wire of FIG. 21 according to one embodiment of the present subject matter. [Figure 24]22 illustrates yet another example of a front end of an implantable device for use with the push wire of FIG. 21 according to an embodiment of the present subject matter. [Figure 25] 1 is a flowchart illustrating a method for anchoring an implantable device to tissue, according to one embodiment of the present subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0009] 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 detail to enable those skilled in the art to practice the subject matter. References to "one embodiment" or "various embodiments" in this disclosure do not necessarily refer to the same embodiment, but may be intended to refer to more than one embodiment. The following detailed description is illustrative and is not to be construed in a limiting sense. The scope of the present subject matter is defined by reference to the appended claims, along with the full scope of legal equivalents to which such claims are entitled.

[0010] Described herein are mechanisms for anchoring an implantable device to surrounding tissue for treating urinary incontinence. The implantable device includes, for example, an adjustable membrane element connected to a rear port by a conduit. The conduit has a lumen communicating a chamber of the adjustable membrane element with an internal cavity of the rear port. Various structural elements of an implantable device described herein (e.g., implantable device 110 shown in FIG. 1 ) may 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 as, for example, an adjustable element, an expandable element, an expandable membrane element, a forwardly expandable membrane element, a balloon, or an adjustable balloon. The “conduit” (e.g., conduit 114 shown in FIG. 1 ) may 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. A "rear port" (e.g., rear port 116 shown in FIG. 1) may also be referred to as, for example, a rear port portion or a rear port element. A "lumen" (e.g., first lumen 215 and second lumen 217 shown in FIG. 2) may also be referred to as, for example, a passageway, an inner passageway, or an internal passageway.

[0011] In one example, the implantable device includes an adjustable balloon connected to a port by a conduit. The balloon is positioned near the urethra and applies non-circumferential compression to the urethral wall. The effectiveness of the treatment depends on proper positioning of the balloon within the patient, such as in the retropubic space near the urethrovesical junction above the urogenital diaphragm, adjacent to the urethral wall. When two balloons (e.g., two implantable devices) are used, they are generally preferably positioned symmetrically and transversely to the urethra. Medical imaging techniques, such as fluoroscopy or transrectal ultrasound (TRUS), can be used to assist in balloon positioning. As described in U.S. Patent Application Publication No. 16 / 450,246, filed June 24, 2019, sensors integrated into the implantable device and / or one or more surgical instruments may also be used to assist in balloon positioning.

[0012] During the implantation procedure, the implantable device is placed in the patient's body with the balloon positioned and secured in place at the target site. The balloon is slightly inflated, typically to a maximum of 1.0 cc, for 4-6 weeks to allow a tissue encapsulation reaction to occur and stabilize the balloon at the target site. Especially if encapsulation does not occur, the implantable device has a tendency to migrate within the dilation channel used to implant it. Therefore, securing the device during the implantation procedure is very important. Following encapsulation, the patient may undergo one or more adjustment procedures to adjust the amount of fluid in the balloon to achieve and maintain continence without causing undesirable obstruction.

[0013] The present subject matter provides implantable devices for treating urinary incontinence having a fixation mechanism for preventing undesired displacement of the implantable device's balloon. Figures 1-10 illustrate various embodiments of implantable devices that can incorporate fixation mechanisms, as well as implantable surgical instruments that can also be used to activate and deactivate the fixation mechanisms. Various embodiments of implantable devices and surgical instruments are shown in Figures 1-10 and described below by way of example and not limitation. Examples of such devices and surgical instruments, as well as other examples of implantable devices and surgical instruments, are described in U.S. Patent Nos. 5,964,806, 6,045,498, 6,419,624, 6,579,224, and 8,926,494, all of which are assigned to UroMedica and are incorporated herein by reference. Figures 13-24 illustrate various embodiments of fixation mechanisms incorporated into implantable devices.

[0014] FIG. 1 illustrates an elongate implantable device 110 in accordance with the present subject matter. The implantable device 110 includes an adjustable membrane element 112, shown at its fully expanded size. The adjustable membrane element 112 is sealingly attached to an elongate conduit 114 connected to a rear port 116. The rear port 116 communicates with the expandable element 112 via a first lumen 215 (FIG. 2). The conduit 114 has a front end 114A that extends slightly beyond the expandable element 112. A syringe 120 includes a hollow needle 121 and an axially movable rear plunger 122. The syringe 120 is used to expand the adjustable membrane element 112 by adjustably injecting a suitable flowable material into the implantable device 110 via the rear port 116.

[0015] In various embodiments, the implantable medical device 110 is deployed during the implantation procedure using a push wire (also referred to as a push rod) as a surgical instrument. The conduit 114 has one or two elongate lumens or passageways. Figures 9 and 10 show an example of an implantable medical device 110 (without a fixation mechanism) deployed using a push wire.

[0016] In various other embodiments, the implantable medical device 110 is positioned during the implantation procedure using a guide probe (also referred to as a guidewire) as a surgical instrument. This implantation method is also referred to as an over-the-wire method. As further shown in FIGS. 2 and 3 , the conduit 114 has two elongate lumens or passageways. The first lumen 215 forms an internal passageway for a flowable material delivered from a cavity 216A of the rear port 116 to expand the adjustable membrane element 112. The conduit 114 is integrally attached to the rear port 116 at its rear end. The second lumen 217 extends from the front opening 117A to the rear opening 117B and functions to receive an elongate guide probe ( FIG. 4 ) to deliver the implantable device 110 to a desired location within the patient's body tissue.

[0017] A key feature of the implantable device 110 having a first lumen 215 is the first opening 215A, which is located in a cavity 216A of the rear port 116. The cavity 216A is located between an elastic septum 218 and the conduit 114 and is connected to the first lumen 215. Flowable material is injected through the first opening 215A. A second opening 215B of the first lumen 215 functions to deliver a working fluid to the adjustable membrane element 112. To adjust the membrane volume, fluid supplied from a hollow needle 121 of a syringe 120 is injected through the septum 218 and passes through the conduit 114 connected to the adjustable membrane element 112. The diameter of the rear port 116 is preferably larger than the diameter of the conduit 114 to accommodate the cavity 216A and the septum 218. The septum 218 is secured in place by a clamping ring 119.

[0018] The entire implantable device 110, including the adjustable membrane element 112, can be formed of a biocompatible material such as silicone or polyurethane elastomer, with the conduit 114 and rear port 116 formed as a unitary structure. Optionally, the adjustable membrane element 112, rear port 116, and conduit 114 can be integrally molded. As shown in FIG. 2, the front end of the adjustable membrane element 112 is adhered at 213 to the conduit tube 114 with a suitable adhesive material.

[0019] The subject implantable device and assembly includes three main components. The first component, the elongate guide member, is configured as a rigid, solid elongate guide probe 424 (FIG. 4). As generally shown in FIGS. 4 and 5, the guide probe 424 is configured to deliver the implantable device 110 to a desired location in a patient's body tissue. Alternatively, the elongate guide member may be configured as a flexible guidewire. Such a guidewire may be initially delivered to the body tissue via a separate, hollow, rigid probe inserted into the body tissue at the desired location. The second component of the assembly, the implantable device 110, includes an adjustable membrane element 112, a conduit 114 with two lumens 215 and 217, and a rear port 116. During implantation, the solid elongate guide probe 424 is first surgically inserted into the patient's body tissue to form an initial pathway, after which the implantable device 110 is guided to a predetermined location within the patient's body adjacent a body lumen. The implantable device 110 is guided by placing the leading lumen opening 117A of the implantable device 110 over the trailing end of the guide probe 424 to a predetermined location within the body tissue adjacent to the body lumen that the adjustable membrane element 112 (in its contracted state) adjustably restricts. The diameter of the second lumen 217 is slightly larger than the diameter of the guide probe 424 to allow the implantable device 110 to easily slide over the probe member.

[0020] To implant the implantable device 110, a physician first makes a small incision in the patient's skin 430 near the body lumen 432 that needs to be restricted. Using visualization tools, such as fluoroscopy or ultrasound imaging, the solid guide probe 424 is then advanced to the desired location, depending on the patient's anatomy. Then, with the adjustable membrane element 112 in its initial, unexpanded, or contracted state, the opening 117A of the second lumen 117 of the conduit 114 is slid over the rear end 424A of the guide probe 424. The front end 114A of the conduit 114 may be pointed to facilitate passage of the implantable device 110 through tissue. The guide probe 424 slides through the second lumen 217 of the conduit 114 and exits through the rear opening 117B. As shown in FIG. 2 , the opening 117B is located between the adjustable membrane element 112 and the rear port 116. However, it may be beneficial to locate the opening 117B near the adjustable membrane element 112, or it may be beneficial for the second lumen 217 to extend through the rear port 116.

[0021] Optionally, the guide probe 424 may include a marking 533. Aligning the marking 533 with a feature of the implantable device 110, such as the rear port 116, may assist in proper placement of the implantable device 110 at the correct depth within the patient's body tissue 430. To facilitate placement of the septum 218 close to the patient's skin, it may be necessary to provide multiple lengths of the conduit 114. Alternatively, the conduit 114 may be shaped like a helix, similar to a coiled spring, to allow the effective length of the conduit 114 to be adjustable.

[0022] After the implantable device 110 is advanced over the guide probe 424 to position the contracted adjustable membrane element 112 at a desired location near the body lumen 432, the body lumen 432 can be restricted to a desired degree by piercing the septum 218 with the needle 121 of the syringe 120 and injecting a flowable material into the adjustable membrane element 112 via the first lumen 215. A physician can determine the desired degree of restriction of the body lumen 432, such as by injecting fluid into the body lumen and passing it through the restriction and measuring backpressure.

[0023] 1 and 6, the source of the flowable material is typically a syringe 120 having a hollow needle that is used to pierce the elastomeric septum 218. However, another fluid container with a means for providing a bidirectional connection to the implantable device 110 may also be used. The flowable material may be, for example, saline, a flowable gel, or a slurry of particles in a liquid carrier. It may also be beneficial to use a radiopaque flowable material so that the degree of membrane expansion is visible by x-ray.

[0024] Another method of delivering the implantable device 110 involves withdrawing the guide probe 424 from the body tissue and then inflating the adjustable membrane element 112. Yet another method involves first placing the implantable device 110 outside the body over the solid guide probe 424 and then inserting both into the body tissue as a unit. To facilitate this latter method, some friction between the solid guide probe 424 and the second lumen 217 in the conduit 114 may be desirable.

[0025] After the implantable device 110 is properly positioned with the adjustable membrane element 112 positioned near the body lumen 432 and the septum 218 of the rear port 116 positioned near the skin 430, a flowable material is injected into the device from the syringe 120. The expandable member is allowed to expand to a certain extent and then may be deflated to an extent suitable for encapsulation of the expandable member by the body tissue. The guide probe 24 is then withdrawn from the device, leaving the slightly expanded membrane element within the body tissue. The skin incision 431 is then closed over the port 116, for example, by means of sutures 834 as shown in FIG. 8 .

[0026] The subject implantable device 110 allows for post-operative adjustment of the membrane expansion. This adjustment is made possible by the septum 218 being located remotely from the adjustable membrane element 112, but beneath the patient's skin in a location proximal to the skin. For example, the location of the port and septum can be identified, such as by palpation of the skin area, and material can be added or removed from the expandable member by inserting a syringe needle through the skin and septum, thereby increasing or decreasing the degree of restriction of the body lumen.

[0027] To ensure a tight seal at the septum 218, the septum 218 is placed in compression within the cavity 216A by placing a tightly fitting metal ring 119 around the port, the metal ring 119 being smaller in diameter than the rear port 116. After the needle 121 of the syringe 120 is withdrawn from the septum 218 following expansion or adjustment of the adjustable membrane element 112, a tight seal is maintained around the septum 218.

[0028] FIGS. 4-8 generally illustrate an "over-the-wire" method or procedure for properly implanting an implantable device 110 into a patient's body tissue. As shown in FIG. 4, after locating a body lumen, such as the patient's urethra, a physician forms a small incision 431 and inserts a guide probe 424 into the body tissue to a desired location near the body lumen 432. This procedure is typically performed by the physician under local anesthesia using visual guidance, such as fluoroscopy. The physician then positions the implantable device 110 over the guide probe 424 through the second lumen 217, as shown in FIGS. 1 and 2. The guide probe 424 enters through the posterior opening 117B and exits through the anterior opening 117A. The implantable device 110, having a sufficiently flexible conduit 114, is advanced through the body tissue along the guide probe 424.

[0029] After reaching the desired location within the body tissue, a suitable flowable material is introduced into the implantable device 110 from a source, such as a syringe 120 having a hollow needle 121 inserted through the septum 218, to at least partially expand the adjustable membrane element 112, as shown in FIG. 6. The guide probe 424 is then removed, and the adjustable membrane element 112 is further expanded to a desired expanded size to restrict the body lumen 432. After the syringe 120 is removed from the implantable device 110, the elastic septum 218 maintains the adjustable membrane element 112 at the desired size. The patient's incision 431 is then surgically closed using sutures 834 over the port 116 and septum 218.

[0030] FIGS. 9-24 show examples of implantable devices and examples of push wires that can be deployed using a push wire. A method or procedure for properly implanting such an implantable device into a patient's body tissue is similar to the over-the-wire method or procedure shown in FIGS. 4-8, except that a push wire is used instead of a guide probe. After locating a body lumen, such as the patient's urethra, a physician forms an incision and inserts a sheath into the body tissue to a desired location near the body lumen. The physician then places the implantable device into the sheath, e.g., with the push wire pre-inserted into the push wire lumen and pushes the push wire to advance the implantable device to a desired location within the body tissue. The sheath is then withdrawn from the patient's tissue, and the adjustable membrane element of the implantable device is expanded to a desired size.

[0031] 9 is a cross-sectional view of an implantable device kit 940 according to one embodiment of the present subject matter. The implantable device kit 940 includes an implantable device 910 having an adjustable membrane element 912 and an elongate conduit 914. The conduit 914 has at least a first lumen 915 extending longitudinally therethrough from a first opening 915A at a trailing end (also referred to as a proximal end) 962 to a second opening 915B. The implantable device 910 is shown positioned within a channel 944 of a sheath 946.

[0032] The implantable device kit 940 further includes a rear port 916 coupled to a rear end 962 of the conduit 914. In one embodiment, the rear port 916 is coupled to the rear end 962 of the elongated body 914 by a chemical adhesive or by sonic welding techniques known in the art. In another embodiment, the rear port 916 and the rear end 962 are formed together by a polymer molding process, such as liquid injection molding, known in the art.

[0033] The rear port 916 has a cavity 916A, which communicates with the first opening 915A of the conduit 914. In one embodiment, the rear port 916 also has a resilient septum 918 for accessing the cavity 916A, which is self-sealing, for example, after repeated punctures with a needle. In one embodiment, the resilient septum 918 is retained in the rear port 916 by a clamping ring 919 disposed around the rear port 916. In one embodiment, the clamping ring 919 is made of a biocompatible material, such as titanium. In one embodiment, the resilient septum 918 is made of a biocompatible material, such as silicone or polyurethane. The rear port 916 has an outer diameter defined by an outer surface 954 of the rear port 916. In one embodiment, the outer diameter of the rear port 916 is between 1 and 15 millimeters, and in one particular example, is 4.5 millimeters.

[0034] In one embodiment, the outer surface of the rear port 916 and the adjustable membrane element 912 are sized (e.g., diameter) smaller than the inner size (e.g., diameter) of the channel 944 to allow longitudinal movement of the implantable device 910 through the channel 944 of the sheath 946. In an alternative embodiment, the rear port 916 includes at least one material that is sufficiently flexible so that the rear port 916 in its relaxed state can be compressed to a small enough size to allow longitudinal movement of the implantable device 910 through the channel 944 of the sheath 946. In various embodiments, the conduit 914 has a sufficiently high stiffness that a force applied to the rear end of the tubular elongate body of the conduit 914 can at least partially move the implantable device 910 through the channel 944 of the sheath 946. In one embodiment, the stiffness of the conduit 914 is determined by the type of material used to form the tubular elongate body of the conduit 914. Alternatively, a support element can be added to the tubular elongate body. For example, a metal coil may be disposed longitudinally within the tubular elongate body to increase the stiffness of the tubular elongate body.

[0035] Once the implantable device 910 is positioned within the body, the adjustable membrane element 912 is inflated by releasably connecting a source of flowable material to the rear port 916. In one embodiment, the source of flowable material comprises a syringe with a non-coring needle, which is inserted through the elastic septum 918. A measured amount of fluid can be introduced into the implantable device 910, and the adjustable membrane element 912 expands or contracts depending on the amount of flowable material introduced from the source into the cavity 916A of the rear port 916. The body lumen is then at least partially and adjustably restricted by the adjustable membrane element 912. Examples of fluids suitable for injection into the prosthetic device include, but are not limited to, normal saline, polymer gels such as silicone gel, hydrogels such as polyvinylpyrrolidone, polyethylene glycol, or carboxymethylcellulose, high viscosity liquids such as hyaluronic acid, dextran, polyacrylic acid, polyvinyl alcohol, and radiopaque fluids such as isotonic contrast agents. After the adjustable membrane element 912 is inflated, the needle is withdrawn from the septum of the rear port 916. In another embodiment, a detectable marker 970 is embedded in the continuous wall of the adjustable membrane element 912. The detectable marker 970 allows the location of the adjustable membrane element 912 within the patient's tissue to be identified using any number of visualization techniques involving electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker 970 is formed from tantalum, and the visualization technique used to visualize the adjustable membrane element 912 is x-ray or fluoroscopy, as are well known in the art.

[0036] In another embodiment, a detectable marker is embedded in the implantable device 910. For example, the detectable marker 970 is located at the leading end (also referred to as the tip) 960 (e.g., at the tip) of the conduit 914. Alternatively, the detectable marker may be located on a continuous wall of the adjustable membrane element 912. The detectable marker 970 allows the location of the leading end 960 or the adjustable membrane element 912 within the patient's tissue to be identified using any number of visualization techniques involving electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker 970 is formed of tantalum, and the visualization techniques used to visualize the leading end 960 or the adjustable membrane element 912 are x-ray or fluoroscopy, which are well known in the art. In another embodiment, the sheath also has a detectable marker, which may be incorporated into or on the wall of the sheath. Alternatively, the entire sheath may be formed to be radiopaque.

[0037] 10 illustrates another embodiment of an implantable device 1010 in accordance with the present subject matter. The implantable device 1010 includes an adjustable membrane element 1012 and a conduit 1014. The conduit 1014 has a front end 1060. In one embodiment, the outer periphery of the conduit 1014 connects and seals to the adjustable membrane element 1012. In one embodiment, the adjustable membrane element 1012 includes a continuous wall having an inner surface defining a chamber.

[0038] The conduit 1014 has a first lumen 1015 and a second lumen 1017. In one embodiment, the first lumen 1015 extends longitudinally within the conduit 1014 from a first opening 1015A to one or more second openings 1015B (e.g., two openings shown in FIG. 10 ). The second openings 1015B communicate with a chamber of the adjustable membrane element 1012 to adjustably expand or contract the adjustable membrane element 1012 with a flowable material introduced through the first opening 1015A. To prevent leakage of fluid from the adjustable membrane element 1012, the first lumen 1015 has a closed end at or near the front end 1060 of the conduit 1014. The closed end can be formed by sealing the front end of the first lumen 1015 using, for example, a silicone adhesive. Alternatively, the first lumen 1015 may be manufactured to terminate before reaching the front end of the conduit 1014 .

[0039] The second lumen 1017 extends longitudinally along the conduit 1014 from the inlet 1017A to the closed end 1017B of the front end 1060. In one embodiment, the second lumen 1017 and the inlet 1017A each have a diameter sufficient to accommodate a push rod used to advance the implantable device 1010 within tissue.

[0040] The implantable device 1010 further includes a rear port 1016 coupled to the rear end of the conduit 1014. In one embodiment, the rear port 1016 is similar to the rear port 916 and includes a cavity 1016A and a resilient septum 1018. The cavity 1016A is coupled to and communicates with the first lumen 1015 at a first opening 1015A. The resilient septum 1018 allows needle access to the cavity 1016A for the introduction and / or withdrawal of fluids to expand (inflate) and / or contract the adjustable membrane element 1012. The diameter of the resilient septum 1018 is slightly larger than the diameter of the cavity 1016A, causing compression of the resilient septum 1018 to provide a more secure seal.

[0041] FIG. 11 is a top view of the bladder 1101 and urethra 1102 illustrating the approximate target placement site for an implantable device 1110 for improving urethral coaptation, according to one embodiment of the present subject matter. The implantable device 1110 may represent any of the embodiments of the implantable device described herein (with the expandable or adjustable membrane element shown to indicate location), such as, but not limited to, the implantable device 110, the implantable device 910, the implantable device 1010, or implantable devices including various combinations of features of the implantable devices 110, 910, and 1010. A Cartesian coordinate system with X, Y, and Z axes (two of which are shown in each figure) is shown in FIGS. 11-14 to illustrate exemplary orientations of the structures shown in these figures. The Z axis is aligned with the direction of the urethra 1002 at the approximate implantation location. The implantation location is near the bladder neck and urethrovesical junction in radical prostatectomy cases, and at the apex of the prostate, further down the urethra, after transurethral resection of the prostate (TURP).

[0042] 12 is a view along the length of the urethra 1102 (or along the Y-axis) in the implantation region showing the approximate target placement site of an implantable device 1110 for improving urethral coaptation, according to one embodiment of the present subject matter. The present subject matter can aid in the correct placement of the implantable device 1110 during implantation in a patient and / or adjustment of the implantable device 1110 after implantation. Application of the present subject matter can particularly facilitate accurate placement of the implantable device 1110 along the Y-axis (sagittal view).

[0043] 13 illustrates an implantable device kit 1320 including an implantable device 1310 and a push wire 1324, according to one embodiment of the present subject matter. The implantable device 1310 and push wire 1324 can be provided as a device kit, which may also include other accessories. The implantable device 1310 can be used to join a body lumen and includes an adjustable membrane element 1312, an elongate conduit 1314, a rear port 1316, and a fixation mechanism 1350. The adjustable membrane element 1312 is configured to join a body lumen and includes a continuous wall having an inner surface defining a chamber. The conduit 1314 has a rear conduit end 1314A, a front conduit end 1314B connected to the adjustable membrane element 1312, an outer periphery that connects to and seals against the adjustable membrane element 1312 near the front conduit end 1314B, and a push wire lumen 1317 that extends longitudinally within the conduit 1314 from a lumen entrance 1317A near the rear conduit end 1314A to a front lumen 1317B at the front conduit end 1314B. The lumen entrance 1317A is sized to accommodate a portion of the push wire 1324. The front lumen 1317B may be a closed front end to allow the push wire 1324 to push against the implantable device 1310, or it may be an exit through which a portion of the push wire 1324 can exit, depending on the type of fixation mechanism 1350. The push wire lumen 1317 has a diameter that can accommodate at least a portion of the push wire 1324 entering through the lumen entrance 1317A. This diameter allows the push wire 1324 to move longitudinally within the push wire lumen 1317 by pushing on the portion of the push wire 1324 that is outside the conduit 1314. Longitudinal movement of the push wire 1324 not only advances the implantable device 1310 within the tissue but also operates the fixation mechanism 1350. This diameter also allows the push wire 1324 to rotate within the push wire lumen 1317 by rotating the portion of the push wire 1324 that is outside the conduit 1314 when rotational movement of the push wire 1324 is used to operate the fixation mechanism 1350.

[0044] The rear port 1316 is coupled to the conduit rear end 1314A and has a cavity that communicates with the chamber of the adjustable membrane element 1312 via an inflation lumen (not shown in FIG. 13) in the conduit 1314. This allows 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.

[0045] In various embodiments, the implantable device 1310 is a multi-lumen (eg, dual-lumen) implantable device having a pushwire lumen 1317 and an inflation lumen (not shown in FIG. 13) as separate lumens.

[0046] The fixation mechanism 1350 is coupled to the leading end of the conduit 1314B and anchors the implantable device 1310 to tissue, thereby preventing displacement of the implantable device 1310 within the tissue after implantation. In various embodiments, the fixation mechanism 1350 anchors the implantable device 1310 to tissue by actively capturing a portion of tissue within the fixation mechanism 1350. The fixation mechanism 1350 has a space that allows the captured portion of tissue to remain viable permanently. The fixation mechanism 1350 is also configured to release the captured portion of tissue for repositioning the implantable device 1310 within the tissue or for removal of the implantable device 1310 from the tissue. In various other embodiments, the fixation mechanism 1350 anchors the implantable device 1310 to tissue by extending fixation members into the tissue. The fixation mechanism 1350 is configured to allow the anchoring member to be detached from the tissue for repositioning the implantable device 1310 in the tissue or for removal of the implantable device 1310 from the tissue.

[0047] Implantable device 1310 represents a suitable combination of implantable device and fixation mechanism 1350 selected from the implantable devices described with reference to Figures 1-10, such as, but not limited to, implantable device 110, implantable device 1010, or implantable devices including various combinations of features of implantable devices 110, 910, and 1010.

[0048] The push wire 1324 includes an elongate push wire body 1326 having a trailing push wire end 1326A and a leading push wire end 1326B. The leading push wire end 1326B may have any suitable shape for advancing the implantable device 1310 within tissue as well as for manipulating (e.g., activating and / or deactivating) the fixation mechanism 1350. The elongate push wire body 1326 has a diameter that allows longitudinal movement within the push wire lumen 1317 of the conduit 1314. Longitudinal movement of the push wire 1324 involves moving the push wire 1324 along its longitudinal axis (substantially parallel to the longitudinal axis of the conduit 1314). The push wire body 1326 has a diameter that is suitable for rotation within the push wire lumen 1317 of the conduit 1314. Rotational movement of the push wire 1324 involves rotating the push wire 1324 about its longitudinal axis.

[0049] As used herein, "activation" of a fixation mechanism refers to the operation of the fixation mechanism to secure the implantable device to tissue, and "deactivation" of the fixation mechanism refers to the operation of releasing the implantable device from tissue. Thus, a fixation mechanism is activated (i.e., in an activated state) when it is in a state that secures the implantable device to tissue, and is deactivated (i.e., in a deactivated state) when it is not in a state that secures the implantable device to tissue.

[0050] As used herein, terms such as "substantially," "generally," "approximately," and "approximately" may refer to imperfections or inaccuracies due to practical factors, such as, but not limited to, manual inaccuracies and manufacturing variations. For example, a push wire is "substantially parallel" when partially positioned within a conduit push wire lumen because the longitudinal axis of the push wire and the longitudinal axis of the conduit push wire lumen are not perfectly parallel due to (1) variations within manufacturing tolerances, (2) manually controlled movement of the push wire within the push wire lumen, or (3) portions of the push wire extending outside the push wire lumen. Such terms (e.g., "substantially," "generally," "approximately," and "approximately") may also refer to small deviations due to design. For example, in a configuration in which the push wire lumen is "substantially parallel" to the conduit longitudinal axis, a small portion of the push wire lumen adjacent the inlet (on the side of the conduit) is not, by design, parallel to the conduit longitudinal axis. In a multi-lumen implantable device, the pushwire lumen is "substantially parallel" to the longitudinal axis of the conduit, with the majority of the pushwire lumen being off-center of the conduit to allow space for the inflation lumen, but the forward end of the pushwire lumen may terminate at the center of the forward end of the conduit rather than parallel to the longitudinal axis of the conduit.

[0051] 14 illustrates an implantable device kit 1420 including an implantable device 1410 and a push wire 1324, according to one embodiment of the present subject matter. The implantable device 1410 and the push wire 1324 can be provided as a device kit, which may also include other accessories. The implantable device 1410 can be used to join body lumens and includes an adjustable membrane element 1412, an elongate conduit 1414, a rear port 1416, and a fixation mechanism 1450. The adjustable membrane element 1412 is configured to join body lumens and includes a continuous wall having an inner surface defining a chamber. The conduit 1414 has a rear conduit end 1414A, a front conduit end 1414B connected to the adjustable membrane element 1412, an outer periphery connected to and in intimate contact with 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 located at the rear conduit end 1414A, a front lumen opening 1415B, and a front lumen end 1415C. The front lumen opening 1415B communicates with a chamber of the adjustable membrane element 1412, allowing the adjustable membrane element 1412 to be expanded by injecting fluid into the chamber and to be deflated by withdrawing fluid from the chamber. The leading lumen end 1415C allows the push wire 1324 to advance the implantable device 1410 within tissue and / or to operate the fixation mechanism 1450. The leading lumen end 1415C is a closed end configured to prevent fluid leakage from the lumen 1415.

[0052] The rear port 1416 is coupled to the rear end of the conduit 1414A and has a cavity 1419 that communicates with the chamber of the adjustable membrane element 1412 via an inflation lumen 1415. This allows the adjustable membrane element 1412 to expand by injecting fluid into the chamber and to contract by withdrawing fluid from the chamber. The cavity 1419 is sealed by a resilient septum 1418. The septum 1418 is self-sealing after being pierced, for example, by a hollow needle connected to a syringe for injecting and withdrawing fluid. In some embodiments, the rear port 1416 is releasably coupled to the rear end of the conduit 1414A.

[0053] In various embodiments, the implantable device 1410 is a single-lumen implantable device having an inflation lumen 1415 that also functions as a pushwire lumen. The inflation lumen 1415 meets the above requirements of the pushwire lumen 1317, with the pushwire lumen entrance at the inflation lumen rear end 1415A. The pushwire 1324 enters the inflation lumen 1415 by piercing the septum 1418.

[0054] The fixation mechanism 1450 is coupled to the leading end of the conduit 1414B and anchors the implantable device 1410 to tissue, thereby preventing displacement of the implantable device 1410 within the tissue after implantation. In various embodiments, the fixation mechanism 1450 anchors the implantable device 1410 to tissue by actively capturing a portion of tissue within the fixation mechanism 1450. The fixation mechanism 1450 has a space that allows the captured portion of tissue to remain viable permanently. The fixation mechanism 1450 is also configured to release the captured portion of tissue for repositioning the implantable device 1410 within the tissue or for removal of the implantable device 1410 from the tissue. In various other embodiments, the fixation mechanism 1450 anchors the implantable device 1410 to tissue by extending fixation members into the tissue. The fixation mechanism 1450 is configured to allow the anchoring member to be retracted from the tissue for repositioning or removal of the implantable device 1410 from the tissue. In various embodiments, the fixation mechanism 1450 functions with a leak-tight lumen 1415 at the leading lumen end 1415C (in contrast, the fixation mechanism 1350 may or may not require a push wire 1324 exiting the leading lumen end 1317B to operate).

[0055] Implantable device 1410 represents a suitable combination of implantable device and fixation mechanism 1450 selected from the implantable devices described with reference to Figures 1-10, such as, but not limited to, implantable device 910 or implantable devices including various combinations of features of implantable devices 110, 910, and 1010.

[0056] FIG. 15 illustrates another push wire 1524 according to one embodiment of the present subject matter. The implantable device kit 1320 or 1420 includes the push wire 1524 in addition to, or instead of, the push wire 1324. The push wire 1524 is a hollow push wire including an elongated push wire body 1526 and a core lumen 1552 extending longitudinally through the push wire body 1526. The push wire body 1526 includes an elongated push wire body 1526 having a trailing push wire end 1526A and a leading push wire end 1526B. The core lumen 1552 has a trailing opening 1552A at the trailing push wire end 1526A and a leading opening 1552B at the leading push wire end 1526B. In addition to functioning as a push wire 1324, the push wire 1524 allows for the injection and withdrawal of fluids into and from the area surrounding the fixation mechanism 1350 or 1450.

[0057] FIG. 16 illustrates yet another push wire 1624 according to one embodiment of the present subject matter. The implantable device kit 1320 or 1420 includes the push wire 1624 in addition to, or instead of, the push wire 1324 / 1524. The push wire 1624 is another hollow push wire including an elongated push wire body 1626 and a core lumen 1652 extending longitudinally through the push wire body 1626. The push wire body 1626 includes a trailing push wire end 1626A and a leading push wire end 1626B. The core lumen 1652 includes a trailing opening 1652A at the trailing push wire end 1626A and multiple leading openings 1652B at and / or near the leading push wire end 1626B. In addition to its function as a push wire 1324, the push wire 1624 allows for the injection and withdrawal of fluids into and from the area surrounding the fixation mechanism 1350 or 1450. Fixing mechanism example Various embodiments of the fixation mechanisms 1350 and 1450 are described below. Each embodiment is suitable for use as one or both of the fixation mechanisms 1350 and 1450, as will be understood by those skilled in the art from the description herein. For example, some embodiments require a pushwire lumen with an open leading lumen end and are therefore suitable for use as part of the implantable device 1310. Other embodiments can be used with a pushwire lumen or inflation lumen with a closed (leak-tight) leading lumen end and are therefore suitable for use as part of the implantable device 1410. These embodiments are illustrative, rather than limiting, of the various fixation mechanisms according to the present subject matter. 1. Attachment / release via push wire In various embodiments, the fixation mechanism (e.g., fixation mechanism 1350 or 1450) secures the implantable device (e.g., implantable device 1310 or 1410) to tissue by receiving energy transmitted through a push wire (e.g., push wire 1324, 1524, or 1624). In various other embodiments, the fixation mechanism can also release the implantable device from tissue by receiving additional energy transmitted through a push wire. 1.1.Using longitudinal movement of the push wire In various embodiments, the fixation mechanism can secure the implantable device to tissue (i.e., be activated) by engaging a portion of tissue with forward longitudinal movement of the push wire and capturing the engaged portion of tissue with reverse longitudinal movement of the push wire. Forward longitudinal movement of the push wire occurs by pushing the push wire, i.e., applying force toward the front end of the conduit. Reverse longitudinal movement of the push wire occurs by pulling the push wire and / or terminating the push, depending on the type of fixation mechanism. In various other embodiments, the fixation mechanism can release the implantable device from tissue (i.e., become deactivated) without capturing another portion of tissue again by utilizing additional longitudinal movement of the push wire to push out the captured portion of tissue. In some embodiments, the fixation mechanism remains deactivated after the implantable device is released from tissue to prevent unintentional engagement and capture of another portion of tissue while the implantable device is still within the patient. In various embodiments, the implantable device can be released from the tissue by pulling it away from the captured portion of tissue without using the push wire to manipulate the fixation mechanism (i.e., without disabling the fixation mechanism), a method referred to as "pull-out release." The implantable device is configured to allow pull-out release without causing unacceptable tissue and / or device damage. For example, with the fixation mechanism activated, the amount of pulling force (referred to as "pull-out force") required to pull the implantable device from the captured portion of tissue should be small enough to prevent the implantable device from being destroyed within the patient's body.

[0058] In various embodiments, the amount of pullout force is determined experimentally and considered a constraint in the design of the fixation mechanism. The pullout force must be greater than that required to prevent migration of the implantable device within the tissue, but less than the pulling force that would cause unacceptable tissue and / or device damage. For example, excessive pullout force may rupture the implantable device's conduit, leaving the front of the device inside the patient and requiring surgical removal. Experiments with prototype implantable devices have shown that a pullout force of approximately 5 pounds can damage the conduit. The pullout force required to prevent unacceptable migration of the implantable device within the tissue was approximately 1 pound. Therefore, the fixation mechanism should be designed to provide a pullout force of approximately 2 to 4 pounds to allow for pullout release.

[0059] 17A and 17B illustrate the front end of an implantable device 1710 for use with a push wire 1324, according to one embodiment of the present subject matter. The implantable device 1710 is an example of an implantable device 1310 and includes an anchoring mechanism 1750, which is an example of an anchoring mechanism 1350. As shown in FIG. 17, the front end of the implantable device 1710 includes a front portion of an elongate conduit 1714 having a front conduit end 1714B. A push wire lumen 1717 extends longitudinally within the conduit 1714 and has a front lumen end 1717B.

[0060] The locking mechanism 1750 includes a coil spring 1752 and a device tip 1753. Figure 17A shows the spring 1752 in an extended position. Figure 17B shows the spring 1752 in a rest position (i.e., at its natural length). The spring 1752 has a spring rear end 1752A connected to the conduit front end 1714B and a spring front end 1752B. The device tip 1753 is connected to the spring front end 1752B and receives the push wire front end 1326B, and is pushed forward by the push wire 1324 to extend the spring 1752. The spring 1752 extends ( FIG. 17A ) using forward longitudinal motion of the push wire 1324 to engage a portion of tissue and returns to a resting position ( FIG. 17B ) using reverse longitudinal motion of the push wire 1324 to capture the engaged portion of tissue, thereby anchoring the implantable device 1710 to the tissue. Repeated back-and-forth longitudinal movement of the push wire 1324 may be required to adequately stabilize the anchoring. The spring 1752 can release the implantable device 1710 from the tissue without re-capturing another portion of tissue by pushing out the captured portion of tissue using additional longitudinal motion of the push wire 1324. After release, the implantable device 1710 can be moved away from the captured portion of tissue while maintaining the spring 1752 in the extended position to prevent the spring 1752 from engaging and capturing another portion of tissue. In various embodiments, the implantable device 1710 can be released from the tissue by pulling it away from the captured portion of tissue (pull-release) without using the push wire 1324 (to stretch the spring 1752). The implantable device 1710 can be configured to be pull-released without causing unacceptable tissue and / or device damage.

[0061] 18A-18C illustrate wires that can be used to make spring 1752, according to various embodiments of the present subject matter. In various embodiments, spring 1752 is made of metal and has multiple turns. Gaps exist between the turns when the spring 1752 is at rest to maintain the viability of the tissue portion captured by the spring 1752. In various embodiments, spring 1752 is formed from metal wire. Examples of metal wires are wire 1852A shown in FIG. 18A, wire 1852B shown in FIG. 18B, and wire 1852C shown in FIG. 18C. Metal wire 1852A has a semicircular cross-section. The flat surface of a wire with a semicircular cross-section provides a stronger grip on tissue compared to a wire with a circular cross-section. Metal wire 1852B has a generally rectangular cross-section with recesses 1855 and / or 1856 in the wire to create gaps between the turns. The rectangular cross-section of the wire prevents the turns from nesting when the spring is in the rest or compressed position. Metal wire 1852C has a generally semicircular cross-section with protrusions 1857 on the wire to create gaps between the turns. Other examples of metal wire include metal wires with circular cross-sections and braided wires. In various embodiments, the metal wire can have any cross-section and / or characteristics that facilitate engagement of a portion of tissue by the spring in the extended position and / or capture of the engaged portion of tissue by the spring in the rest position, and that maintain viability of the tissue captured by the spring in the rest position over the life of the implantable device.

[0062] In various other embodiments, spring 1752 may be a lattice tube (e.g., a structure similar to an intravascular stent) or a high durometer spiral silicone tube. Spring 1752 can have any structure that is biocompatible and capable of engaging and capturing a portion of tissue through one or more cycles of extension and return to a resting position.

[0063] FIG. 19 illustrates the front end of an implantable device 1710 in use with a push wire 1624, according to one embodiment of the present subject matter. FIG. 19 differs from FIG. 17 in that a push wire 1624 is used instead of the push wire 1324 of FIG. 17. The push wire 1624 is used to facilitate engaging a portion of tissue with the spring 1752 when the push wire 1624 is used to stretch the spring to anchor the implantable device 1710 to tissue, and / or to facilitate pushing a portion of tissue off the spring when releasing the implantable device 1710 from tissue. During anchoring, a syringe 1958 can be used to aspirate fluid (such as air) through the front opening 1652B of the core lumen 1652 of the push wire 1624. This reduces the pressure within the lumen 1652, further drawing tissue into the gaps between the turns of the spring 1752. Upon release, a syringe 1958 is used to inject fluid (such as saline) through the front opening 1652B of the core lumen 1652 of the push wire 1624. This forces the portions of tissue located in the gaps between the turns of the spring 1752 out of the spring 1752.

[0064] 20A-20C illustrate the front end of an implantable device 2010 for use with a push wire 2024, according to one embodiment of the present subject matter. The implantable device 2010 is an example of an implantable device 1310 and includes a fixation mechanism 2050, which is another example of a fixation mechanism 1350. As shown in FIG. 20, the front end of the implantable device 2010 includes a front portion of an elongate conduit 2014 having a front conduit end portion 2014B. A push wire lumen 2017 extends longitudinally within the conduit 2014 and has a front lumen end portion 2017B. The push wire 2024 is an example of a push wire 1324 and includes an elongate push wire body 2026 and a front push wire end portion 2026B configured to operate the fixation mechanism 2050.

[0065] The fixation mechanism 2050 includes a jaw 2064 coupled to the conduit front end 2014B. FIG. 20A is a side cross-sectional view of the jaw 2064 in an open position. FIG. 20B is a side cross-sectional view of the jaw 2064 in a closed position. FIG. 20C is an end view of the jaw 2064 in a closed position. The jaw 2064 opens (FIG. 20A) with a forward longitudinal movement of the push wire 2024 to engage a portion of tissue and closes (FIG. 20B) with a reverse longitudinal movement of the push wire 2024 to capture the engaged portion of tissue, thereby anchoring the implantable device 2010 to the tissue. The jaw 2064 can be released from the tissue without capturing another portion of tissue by pushing out the captured portion of tissue with another longitudinal movement of the push wire 2024. After release, the implantable device 2010 can be moved away from the captured portion of tissue with the clamps 2064 in an open position to prevent the clamps 2064 from engaging and capturing another portion of tissue. In various embodiments, the implantable device 2010 can be released from the tissue by pulling it away from the captured portion of tissue (pull-release) without using the pushwire 2024. The implantable device 2010 is configured to be pull-released without causing unacceptable tissue and / or device damage.

[0066] The push wire front end 2026B has a shape suitable for opening the clamp 2064. In various embodiments, the clamp 2064 includes a radiopaque material such as tantalum or nitinol (an alloy of nickel and titanium) to function as an X-ray marker. 1.2. Use of Rotational Motion of the Push Wire In various embodiments, the fixation mechanism can secure the implantable device to the tissue (i.e., activated) by rotating the push wire in a tightening rotational direction. In various other embodiments, the fixation mechanism can release the implantable device from the tissue (i.e., deactivated) by rotating the push wire in a loosening rotational direction. In one embodiment, the tightening rotational direction is clockwise, and the loosening rotational direction is counterclockwise. In another embodiment, the tightening rotational direction is counterclockwise, and the loosening rotational direction is clockwise. In various embodiments, the implantable device can be released from the tissue by pulling it away from the captured portion of tissue without using the push wire to operate the fixation mechanism (i.e., pull-out release without deactivating the fixation mechanism). The implantable device is configured to perform pull-out release without causing unacceptable tissue and / or device damage. For example, the amount of force required to pull the implantable device from the captured portion of tissue with the fixation mechanism activated should be small enough to prevent the implantable device from being destroyed within the patient's body.

[0067] FIG. 21 illustrates the front end of an implantable device 2110 for use with a push wire 2124, according to one embodiment of the present subject matter. The implantable device 2110 is an example of an implantable device 1310 or 1410 and includes a fixation mechanism 2150, which is another example of a fixation mechanism 1350 or 1450. As shown in FIG. 21 , the front end of the implantable device 2110 includes a front portion of an elongate conduit 2114 having a front conduit end 2114B. A lumen 2117, which is an example of a push wire lumen 1317 or inflation lumen 1415, extends longitudinally within the conduit 2114 and has a front lumen end 2117B. The push wire 2124 is an example of a push wire 1324 and includes an elongate push wire body 2126 and a front push wire end 2126B configured to operate the fixation mechanism 2150.

[0068] The fixation mechanism 2150 is a helix assembly having a base 2167 and a helix 2166 coupled to the base 2167. The base 2167 is coupled to the lumen 2117 at the conduit front end 2114B and is configured to engage the push wire front end 2126B of the push wire 2124. The implantable device 2110 is anchored to tissue by rotating the push wire 2124 (engaged to the base 2167) in a tightening rotational direction so that the helix 2166 enters the tissue. After anchoring, the implantable device 2110 can be released from the tissue by rotating the push wire 2124 in a loosening rotational direction. In some embodiments, the helix 2166 is configured to allow the implantable device 2110 to be released from the tissue by simply pulling the implantable device 2110 from the tissue (pull-out release). For example, the spiral portion 2166 may have multiple turns and may be sized to limit the expected damage to the tissue and / or the implantable device 2110 that may result from pull-out release. In various embodiments, the number of turns of the spiral portion 2166 is determined so as to control the amount of pull-out force by controlling the degree of tightening and turning motion. The amount of pull-out force varies depending on the type of tissue to which the implantable device is secured (e.g., fat, muscle, or scar tissue) and may vary from patient to patient. During the implantation procedure, the procedural physician can determine the number of turns of the spiral portion 2166 to actually drive into the tissue, for example, by incrementally tightening and turning the implantable device while feeling the pull-out force.

[0069] In various embodiments, the base 2167 is watertightly coupled to the lumen 2117 to configure the implantable device 2110 as a single-lumen implantable device with the lumen 2117 functioning as both a pushwire lumen and an inflation lumen. In various other embodiments, the base 2167 is coupled to the pushwire lumen of a multi-lumen implantable device having a separate inflation lumen.

[0070] Several examples of implantable devices 2110 including fixation mechanisms 2150 are described below with reference to Figures 22-24. In various embodiments, considerations in selecting materials for constructing fixation mechanisms 2150 (including the various examples described below with reference to Figures 22-24) include, for example, biocompatibility for long-term implantation, MRI (magnetic resonance imaging) safety, radiopacity, and resistance to galvanic corrosion if multiple materials are used. Examples of suitable materials include titanium, nitinol (nickel titanium), tantalum, and platinum iridium. 1.2.1. A helical part with a base that rotates within a threaded sleeve FIG. 22A illustrates the front end of an implantable device 2210 for use with a push wire 2124, according to one embodiment of the present subject matter. The implantable device 2210 is an example of an implantable device 2110 and includes a helical assembly and an anchoring mechanism 2250, which is an example of an anchoring mechanism 2150. As shown in FIG. 22A, the front end of the implantable device 2210 includes a front portion of an elongate conduit 2214 having a front conduit end 2214B. A lumen 2217, which may function as a push wire lumen (such as the push wire lumen 1317) or as both a push wire lumen and an inflation lumen (such as the inflation lumen 1415), extends longitudinally within the conduit 2214 and has a front lumen end 2217B. The push wire 2124 is an example of a push wire 1324 and includes an elongate push wire body 2126 and a front push wire end 2126B configured to operate the anchoring mechanism 2250.

[0071] Conduit 2214 has a threaded sleeve 2270 attached to the surface of lumen 2217 at conduit front end 2214B. Fixation mechanism 2250 has a threaded base 2267 and a helical portion 2266 coupled to threaded base 2267. Threaded base 2267 and threaded sleeve 2270 mate with one another such that threaded base 2267 can be rotated within threaded sleeve 2270 for longitudinal movement. Threaded base 2267 engages push wire front end 2126B of push wire 2124 such that rotating push wire 2124 in a tightening rotational direction will cause helical portion 2266 to exit lumen 2217 and enter tissue, and such that rotating push wire 2124 in a loosening rotational direction will cause helical portion 2266 to be released from tissue and retracted back into lumen 2217. Additionally, the spiral portion 2266 is configured so that it can be released from the tissue by simply pulling the implantable device 2210 away from the tissue (pull-out release) without causing unacceptable damage to the tissue and / or the implantable device 2210. The threaded sleeve 2270 is sized and positioned within the conduit 2214 to allow the spiral portion 2266 to be positioned completely within the conduit 2214, thereby allowing the spiral portion 2266 to be conveniently spaced away from the exterior surface of the implantable device 2210 during insertion into the patient.

[0072] In various embodiments, the threaded base 2267 and threaded sleeve 2270 are configured to be watertight to configure the implantable device 2210 as a single lumen implantable device with the lumen 2217 functioning as both the pushwire lumen and the inflation lumen. In various other embodiments, the threaded sleeve 2270 is attached to the pushwire lumen of a multi-lumen implantable device where the lumen 2217 is the pushwire lumen (formed separately from the inflation lumen).

[0073] FIG. 22B is another view of the front end of an implantable device 2210 for use with a push wire 2124, according to one embodiment of the present subject matter. FIG. 22A is a top view of the front end of an implantable device 2210, which may be either a single-lumen or a multi-lumen implantable device. FIG. 22B is a side view of the front end of the implantable device 2210. The inflation lumen 2215 has a front lumen opening 2215B that communicates with a chamber of an adjustable membrane element (not shown) of the implantable device 2210. The inflation lumen 2115 is watertight, either by being fabricated to terminate within the conduit 2214 or by having the front conduit end 2214B plugged. 1.2.2. A spiral with a base that rotates within a bushing FIG. 23 illustrates the front end of an implantable device 2310 for use with a push wire 2124, according to one embodiment of the present subject matter. The implantable device 2310 is another example of an implantable device 2110 and includes a helical assembly and a fixation mechanism 2350, which is another example of a fixation mechanism 2150. As shown in FIG. 23 , the front end of the implantable device 2310 includes a front portion of an elongate conduit 2314 having a front conduit end 2314B. A lumen 2317, which may function as a push wire lumen (such as the push wire lumen 1317) or as both a push wire lumen and an inflation lumen (such as the inflation lumen 1415), extends longitudinally within the conduit 2314 and has a front lumen end 2317B. The push wire 2124 is an example of a push wire 1324 and includes an elongate push wire body 2126 and a front push wire end 2126B configured to operate the fixation mechanism 2350.

[0074] Conduit 2314 has a bushing 2371 attached to the surface of lumen 2317 at conduit front end 2314B. Fixation mechanism 2350 has a base 2367 and a helix 2366 coupled to base 2367. Base 2367 is configured to allow base 2367 to rotate within bushing 2371 without longitudinal movement of fixation mechanism 2350 relative to conduit 2314. Base 2367 engages push wire front end 2126B of push wire 2124 such that rotating push wire 2124 in a tightening rotational direction will cause helix 2366 to enter tissue, and rotating push wire 2124 in a loosening rotational direction will cause helix 2366 to be released from tissue. Additionally, the spiral portion 2366 is configured so that it can be released from the tissue by simply pulling the implantable device 2310 away from the tissue (pull-out release) without causing unacceptable damage to the tissue and / or the implantable device 2310. The fixation mechanism 2350 is configured so that the spiral portion 2366 is disposed completely or substantially outside the conduit 2314. The diameter of the spiral portion 2366 is not limited by the diameter of the lumen 2317. In the illustrated embodiment, the diameter of the spiral portion 2366 is larger than the diameter of the lumen 2317 and is substantially the same as the diameter of the conduit 2314 when the leading lumen end 2317B is centered at the leading end of the conduit 2314. In various embodiments, the diameter of the spiral portion 2366 can be larger, substantially the same as, or smaller than the diameter of the lumen 2317 and can be determined based on the amount of force required to hold the implanted device 2310 in place once implanted.

[0075] In various embodiments, the base 2367 and bushing 2371 are configured to be watertight to configure the implantable device 2310 as a single-lumen implantable device with the lumen 2317 functioning as both the pushwire lumen and the inflation lumen. In various other embodiments, the bushing 2371 is attached to the pushwire lumen of a multi-lumen implantable device where the lumen 2317 functions as the pushwire lumen in addition to the inflation lumen. The relative positions of the pushwire lumen and inflation lumen in such multi-lumen embodiments of the implantable device 2310 may be the same as or similar to the implantable device 2210 shown in FIG. 22B. 1.2.3. A spiral with a base fixed to the implantable device FIG. 24 illustrates the front end of an implantable device 2410 for use with a push wire 2124, according to one embodiment of the present subject matter. The implantable device 2410 is another example of the implantable device 2110 and includes a helical assembly and a fixation mechanism 2450, which is another example of the fixation mechanism 2150. As shown in FIG. 24 , the front end of the implantable device 2410 includes a front portion of an elongate conduit 2414 having a front conduit end 2414B. A lumen 2417, which may function as a push wire lumen (such as the push wire lumen 1317) or as both a push wire lumen and an inflation lumen (such as the inflation lumen 1415), extends longitudinally within the conduit 2414 and has a front lumen end 2417B. The push wire 2124 is an example of a push wire 1324 and includes an elongate push wire body 2126 and a front push wire end 2126B configured to operate the fixation mechanism 2450.

[0076] The fixation mechanism 2450 includes a base 2467 and a helix 2466 coupled to the base 2467. The base 2467 is attached to the lumen 2417 at the conduit leading end 2414B via an attachment portion 2472 (e.g., an adhesive layer). The base 2467 engages the push wire leading end 2126B of the push wire 2124 such that rotating the push wire 2124 in a tightening rotational direction causes the helix 2466 to enter tissue, and rotating the push wire 2124 in a loosening rotational direction causes the helix 2466 to release from tissue. Because the base 2467 is attached to the lumen 2417, when the push wire 2124 engages and rotates with the base 2467, the entire implantable device 2410 rotates with the helix 2466. Additionally, the spiral portion 2466 is configured such that the spiral portion 2466 can be released from the tissue by simply pulling the implantable device 2410 away from the tissue (pull-out release) without causing unacceptable damage to the tissue and / or the implantable device 2410. The diameter of the spiral portion 2466 is not limited by the diameter of the lumen 2417. In the illustrated embodiment, the diameter of the spiral portion 2466 is substantially the same as the diameter of the lumen 2417. In various embodiments, the diameter of the spiral portion 2466 can be larger, substantially the same as, or smaller than the diameter of the lumen 2417 and can be determined based on the amount of force required to hold the implanted implantable device 2410 in place once implanted.

[0077] In various embodiments, the base 2467 is watertightly attached and sealed to the lumen 2417 by the attachment 2472 to configure the implantable device 2410 as a single-lumen implantable device with the lumen 2417 functioning as both the pushwire lumen and the inflation lumen. In various other embodiments, the base 2467 is attached to the pushwire lumen of a multi-lumen implantable device, where the lumen 2417 functions as the pushwire lumen in addition to the inflation lumen. The relative positions of the pushwire lumen and inflation lumen in such multi-lumen embodiments of the implantable device 2410 may be the same or similar to the implantable device 2210 shown in FIG. 22B . Compared to multi-lumen implantable devices, single-lumen implantable devices can accommodate a larger diameter pushwire due to the larger diameter of the pushwire lumen. A larger diameter pushwire can rotate the implantable device 2410 with more torque when anchoring or releasing. In various embodiments where the implantable device 2410 is a single-lumen implantable device (such as example implantable device 1410), the implantable device 2410 can be removed from the patient by (1) maintaining the integrity of the implantable device 2410 by rotating the push wire 2124 in a relaxed rotational direction after it has been reinserted through a septum (such as septum 1418), (2) cutting the rear port (such as rear port 1416) and reinserting the push wire 2124 directly into the lumen 2417 and rotating it in a relaxed rotational direction, or (3) withdrawing the implantable device 2410 without using the push wire 2124 (pull-out release). 2. Transluminal fixation / release In various embodiments, the fixation mechanism (such as fixation mechanism 1350 or 1450) secures the implantable device (such as implantable device 1310 or 1410) to tissue by receiving energy transmitted through a lumen (such as pushwire lumen 1315 of implantable device 1310, inflation lumen 1415 of implantable device 1410, core lumen 1552 of pushwire 1524, or core lumen 1652 of pushwire 1624). In various other embodiments, the fixation mechanism can also release the implantable device from tissue by receiving additional energy transmitted through a lumen. In various embodiments, the fixation mechanism may be hydraulically controlled (e.g., hydraulically activated and / or hydraulically deactivated) by flowing one or more fluids through the lumen. 2.1. Use of pressure transmitted through the lumen In various embodiments, to facilitate anchoring of the implantable device to tissue, a portion of tissue is engaged with and captured within the fixation mechanism by withdrawing fluid from a lumen or push wire of the implantable device that provides access to the portion of tissue, thereby generating low pressure or vacuum. The lumen has one or more front openings that allow access to the tissue. Examples of such lumens include a push wire lumen with one or more front openings of the implantable device and a core lumen with one or more front openings of the hollow push wire. In various other embodiments, to facilitate release of the implantable device from tissue, a fluid is injected into the lumen to generate hydraulic pressure, thereby pushing the captured portion of tissue away from the fixation mechanism. Extraction and injection of fluid into the lumen can be accomplished by connecting a syringe to the lumen.

[0078] This pressure method may be used in conjunction with another fixation method configured to facilitate engagement and ejection of a portion of tissue by using a push wire to engage a portion of tissue with a fixation mechanism, capture the engaged portion of tissue to anchor the implantable device to the tissue, and eject the captured portion of tissue with the push wire to release the implantable device, an example of such a method was described above with reference to FIG. 2.2 Utilization of energy transmitted through the lumen In various embodiments, the fixation mechanism secures the implantable device to the tissue by receiving a liquid through the lumen. The liquid causes a thermal or chemical reaction in the fixation mechanism to engage and capture a portion of the tissue within the fixation mechanism. In various other embodiments, the fixation mechanism releases the implantable device from the tissue by receiving another liquid through the lumen. The liquid causes another thermal or chemical reaction in the fixation mechanism to expel the captured portion of the tissue from within the fixation mechanism. A syringe may be connected to the lumen to inject the liquid.

[0079] In one embodiment, the fixation mechanism includes a clamp. The clamps open upon delivery of a hot liquid above the opening threshold temperature to receive a portion of tissue, and then close upon delivery of a cold liquid below the closing threshold temperature to capture the received portion of tissue, thereby securing the implantable device to the tissue. In one embodiment, as shown in FIG. 20 , the implantable device 2010 includes a clamp 2064. The clamp 2064 is formed of a thermally controllable material, and changing the temperature changes the state of the clamp 2064. The clamp 2064 may be used instead of or in addition to the push wire 2024. In this embodiment, the clamp 2064 opens upon injection of a hot liquid into the lumen and closes upon injection of a cold liquid into the lumen. The hot and cold liquids may be the same liquid (e.g., saline) but at different temperatures. Fixation method example 25 is a flowchart illustrating a method 2580 for anchoring an implantable device to tissue, according to one embodiment of the present subject matter. In various embodiments, the implantable device provides controllable junctions of a body lumen within biological tissue, for example, to treat urinary incontinence in a patient. Examples of implantable devices include, but are not limited to, all of the various embodiments of implantable devices described herein (e.g., implantable devices 110, 910, 1010, 1310, 1410, 1710, 2010, 2110, 2210, 2310, and 2410). In one example, but not limited to, method 2580 described below uses a push wire (used as a surgical tool to position the implantable device) to operate (activate and optionally deactivate) the fixation mechanism.

[0080] At 2581, an implantable device is provided. The implantable device includes an adjustable membrane element (also referred to as a balloon) and an elongate conduit. The adjustable membrane element has a continuous wall with an inner surface defining a chamber. The elongate conduit has a conduit outer periphery, a conduit rear end, a conduit front end, and a pushwire lumen. The conduit outer periphery is connected to and adhered to the adjustable membrane element at or near the conduit front end. The pushwire lumen extends longitudinally within the conduit and has an entrance for receiving a portion of the pushwire and a diameter suitable for accommodating the received portion of the pushwire. The implantable device may have a rear port permanently or releasably coupled to the conduit at the conduit rear end. Examples of implantable devices provided at 2281 include, but are not limited to, implantable devices 110, 910, and 1010 and various embodiments thereof described herein.

[0081] In 2582, the implantable device is provided with an anchoring mechanism to prevent displacement of the implantable device after implantation in tissue. That is, the implantable device also has an anchoring mechanism. Examples of such implantable devices 2281 include, but are not limited to, implantable devices 1310, 1410, 1710, 2010, 2110, 2210, 2310, and 2410 and various embodiments thereof described herein.

[0082] At 2583, the fixation mechanism is activated to secure the implantable device to the tissue. In various embodiments, the implantable device may need to be repositioned or removed from the tissue to enhance therapeutic effects. In this case, at 2584, the fixation mechanism is optionally deactivated to release the implantable device from the tissue. In some embodiments, the implantable device is released from the tissue by pulling on the implantable device without deactivating the fixation mechanism (pull-out release). In such embodiments, the fixation mechanism is configured to acceptably limit the amount of damage that may occur to the tissue and / or the implantable device. For example, the fixation force should be limited to an amount that does not rupture the conduit of the implantable device when the implantable device is withdrawn.

[0083] In various embodiments, the implantable device is anchored to the tissue at 2583 by activating the fixation mechanism to capture a portion of the tissue within the fixation mechanism. The implantable device is released from the tissue at 2584 by deactivating the fixation mechanism to release the captured portion of the tissue from the fixation mechanism, or by simply pulling on the implantable device (pull-out release). In various other embodiments, the implantable device is anchored to the tissue at 2583 by activating the fixation mechanism to extend the fixation members of the fixation mechanism into the tissue. The implantable device is released from the tissue at 2584 by deactivating the fixation mechanism to retract the fixation members of the fixation mechanism from the tissue, or by simply pulling on the implantable device (pull-out release).

[0084] In various embodiments, the fixation mechanism is activated at 2583 by transmitting energy through the push wire. Optionally, another energy may be transmitted through the push wire to deactivate the fixation mechanism at 2584. The energy transmitted at 2583 and the energy transmitted at 2584 may be the same type of energy or different types of energy. In one embodiment, the fixation mechanism is activated by longitudinal movement of the push wire and, optionally, deactivated by another longitudinal movement of the push wire. In another embodiment, the fixation mechanism is activated by rotational movement of the push wire in a rotational direction and, optionally, deactivated by rotational movement of the push wire in a counter-rotational direction. In yet another embodiment, the fixation mechanism is activated by delivering non-mechanical energy to the fixation mechanism using the push wire and, optionally, deactivated by delivering another non-mechanical energy to the fixation mechanism using the push wire. In such embodiments, deactivation of the fixation mechanism is optional, and the implantable device may be released by simply pulling on the implantable device without deactivating the fixation mechanism (pull-out release).

[0085] In various embodiments, a fluid is passed through the lumen to activate the fixation mechanism at 2583. Optionally, the fixation mechanism is deactivated at 2584 by passing another fluid through the lumen. This lumen may be the pushwire lumen of the implantable device conduit and / or the core lumen of the pushwire. In such embodiments, deactivation of the fixation mechanism is optional, and the implantable device may be released by simply pulling on the implantable device without deactivating the fixation mechanism (pull-out release).

[0086] This application is intended to cover any adaptations or variations of the present subject matter. The above detailed description is exemplary and not limiting. Other embodiments will be apparent to those skilled in the art from 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. An implantable device configured to be placed within the tissue of a living organism using a push wire to join the tubular lumens of the living organism, An adjustable membrane element including a continuous wall having an inner surface defining the chamber, A long conduit comprising a conduit outer surface, a conduit rear end, a conduit front end, and a push wire lumen, wherein the conduit outer surface is connected to and in close contact with the adjustable membrane element at or near the conduit front end, and the push wire lumen extends longitudinally within the conduit and has an inlet for receiving a portion of the push wire and a diameter suitable for accommodating the received portion of the push wire, A helical assembly having a base connected to the push wire lumen at the front end of the conduit and a helical portion connected to the base, wherein the base is configured to engage with the push wire, An implantable device equipped with [a specific feature / method].

2. The helical assembly is configured to fix the implantable device to the tissue by rotation in the tightening rotation direction of the push wire. The implantable device according to claim 1.

3. The helical assembly is configured such that, after the implantable device is fixed to the tissue, the rotation of the push wire in the slack rotation direction releases the implantable device from the tissue. The implantable device according to claim 2.

4. The helical assembly is further configured to allow the implantable device to be released from the tissue by pulling the implantable device from the tissue while limiting damage to the tissue to an acceptable degree. The implantable device according to claim 2.

5. The elongated conduit further comprises a threaded sleeve attached to the surface of the push wire lumen at or near the front end of the conduit, the base includes a threaded base, and the threaded base is The rotation of the push wire in the tightening rotation direction allows the helical portion to exit the push wire lumen at the front end of the conduit and enter the tissue, and The screwed sleeve is configured to engage with the push wire such that the helical portion retracts from the tissue and returns to the lumen of the push wire due to rotation in the slack rotation direction of the push wire. The implantable device according to claim 2.

6. The elongated conduit further comprises a bushing attached to the surface of the push wire lumen at or near the front end of the conduit, and at least a portion of the base is The rotation of the push wire in the tightening rotation direction allows the helical portion to enter the tissue, and The bushing is positioned such that the helical portion can retract from the tissue due to the rotation of the push wire in the slack rotation direction. The implantable device according to claim 2.

7. The base is attached to the surface of the push wire lumen at or near the front end of the conduit, The rotation of the push wire in the tightening rotation direction allows the helical portion to enter the tissue, and The adjustable membrane element and the elongated conduit rotate together with the helical portion and the base so that the helical portion can retract from the tissue by rotation in the slack rotation direction of the push wire. The implantable device according to claim 2.

8. The aforementioned helical assembly is made of titanium. The implantable device according to claim 1.

9. The aforementioned helical assembly is made of nickel-titanium. The implantable device according to claim 1.

10. The aforementioned helical assembly is formed of tantalum. The implantable device according to claim 1.

11. The aforementioned helical assembly is formed of platinum iridium. The implantable device according to claim 1.

12. In addition to the push wire lumen, there is an expansion lumen extending longitudinally within the conduit, separate from the push wire lumen, having a rear opening located at the rear end of the conduit and a front opening communicating with the chamber of the adjustable membrane element to allow the adjustable membrane element to be adjustablely expanded or contracted by a fluid material introduced through the rear opening. The rear port, connected to the conduit at the rear end of the conduit, further comprises a rear port having a cavity and an elastic septum configured to seal the cavity, wherein the cavity is configured to contain the fluid material and communicates with the expansion lumen through the rear opening of the expansion lumen. An implantable device according to any one of claims 1 to 11.

13. The push wire lumen has an inlet which is a rear opening located at the rear end of the conduit, and a front opening which communicates with the chamber of the adjustable membrane element to allow the adjustable membrane element to be adjustablely expanded or contracted by a fluid material introduced through the rear opening. The rear port, connected to the conduit at the rear end of the conduit, further comprises a rear port having a cavity and an elastic septum configured to seal the cavity, wherein the cavity is configured to contain the fluid material and communicates with the push wire lumen through the rear opening of the push wire lumen. An implantable device according to any one of claims 1 to 11.

14. The base is connected to the push wire lumen in such a way that it is watertight. The implantable device according to claim 13.

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