Implantable urinary continence device kit

Abstract

To provide an apparatus for monitoring an implantable device for urinary continence.SOLUTION: One or more sensors are incorporated onto one or more of an implantable device and a surgical tool used for placement and / or adjustment of the implantable device. The implantable device includes an adjustable membrane element for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence. In various embodiments, the one or more sensors can be configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, or a shape of the body lumen.SELECTED DRAWING: Figure 23

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present specification relates generally to implantable medical devices, and more particularly to methods and systems for monitoring the placement and / or adjustment of implantable devices for treating urinary incontinence. [Background technology]

[0002] One example of an implantable device for treating urinary incontinence includes an adjustable membrane element, such as a balloon, connected to a rear port by a conduit. The implantable device can be implanted in a patient using an adjustable membrane element positioned adjacent to the patient's urethra and a rear port placed under the patient's skin via minimally invasive surgery. The adjustable membrane element can be adjusted during and after surgery by injecting fluid into the rear port or percutaneously extracting fluid from the rear port using a needle. In an exemplary treatment, two such implantable devices are placed in a patient so that the two adjustable membrane elements provide pressure and support to the patient's bladder neck to protect against accidental urine leakage during sneezing, coughing, or physical activity. The effectiveness of this treatment depends on proper placement in the patient and adjustment of the adjustable membrane element after placement. Summary of the Invention [Means for solving the problem]

[0003] The one or more sensors are incorporated into one or more of the implantable device and surgical instruments used to position and / or adjust the implantable device. The implantable device includes an adjustable membrane element for controllable joining of a body lumen, such as joining of the urethra as a treatment for urinary incontinence. In various embodiments, the one or more sensors can be configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, or a shape of the body lumen.

[0004] In various embodiments, an implantable device for controllably joining a body lumen can include an adjustable membrane element and an elongate conduit. The adjustable membrane element can include a continuous wall having an inner surface defining a chamber. The elongate conduit can include a circumferential surface connected and sealed to the adjustable membrane element, a rear end, a front end, and a lumen extending longitudinally within the elongate conduit from a first opening at the rear end to a second opening. The second opening is in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the adjustable membrane element with a flowable material introduced and applied through the first opening. One or more sensors can be incorporated into the implantable device and / or a sensor probe. The sensor probe is for positioning the implantable device, adjusting the implantable device, and / or monitoring the joining status of the body lumen. In one embodiment, one or more sensors are incorporated into at least one of the adjustable membrane element or the elongate conduit of the implantable device. In another embodiment, the sensor probe includes a front end incorporating a sensor. In one embodiment, the lumen of the elongate conduit is configured to accommodate a portion of the sensor probe, including its front end. In another embodiment, the implantable device includes another lumen extending longitudinally within the elongate conduit. The lumen has an inlet configured to receive a portion of the sensor probe and either a closed end configured to stop the sensor probe or an outlet configured to allow a portion of the sensor probe, including its front end, to exit. In various embodiments, the one or more sensors can include one or more optical sensors, such as a camera or borescope, and / or one or more ultrasound transducers for generating ultrasound images.

[0005] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details regarding the present subject matter are found in the detailed description and appended claims. The scope of the present invention is defined by the appended claims and their legal equivalents. [Brief explanation of the drawings]

[0006] [Figure 1] FIG. 1 is a perspective view of an implantable device and a syringe source for providing flowable material to an adjustable membrane element of the implantable device, according to an embodiment of the present subject matter. [Figure 2] FIG. 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] FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2, according to one embodiment of the present subject matter. [Figure 4] FIG. 4 illustrates a guide probe inserted into body tissue at an implantation location adjacent a patient's body lumen prior to insertion of an implantable device, according to an embodiment of the present subject matter. [Figure 5] FIG. 5 illustrates an implantable device positioned over a guide probe and partially advanced to a desired position with the adjustable membrane element retracted, according to an embodiment of the present subject matter. [Figure 6] FIG. 6 shows an implantable device according to an embodiment of the present subject matter after being expanded at a desired location in a patient's body tissue to move the body tissue toward a body lumen to create an adjustable constraint in the body lumen. [Figure 7] FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 6, according to one embodiment of the present subject matter. [Figure 8] FIG. 8 shows an implantable device after insertion of the rear port under the patient's skin, according to one embodiment of the present subject matter. [Figure 9] FIG. 9 is a schematic diagram of another implantable device, according to an embodiment of the present subject matter. [Figure 10] FIG. 10 is a schematic diagram of another implantable device, according to an embodiment of the present subject matter. [Figure 11] FIG. 11 is a top view showing an approximate target site for placement of an implantable device for improving urethral coaptation, according to an embodiment of the present subject matter. [Figure 12]FIG. 12 is a view along the length of the urethra in the region of implantation showing approximate target sites for placement of an implantable device to improve urethral coaptation, according to an embodiment of the present subject matter. [Figure 13] FIG. 13 is an illustration of an implantable device and a sensor probe, according to an embodiment of the present subject matter. [Figure 14] FIG. 14 is a diagram of a portion of a sensor probe, according to an embodiment of the present subject matter. [Figure 15] FIG. 15 is a view of the front end of a sensor probe, according to an embodiment of the present subject matter. [Figure 16] FIG. 16 is a cross-sectional view of a portion of the front end of an implantable device, according to an embodiment of the present subject matter. [Figure 17] FIG. 17 is a cross-sectional view of a portion of the front end of an implantable device, according to an embodiment of the present subject matter. [Figure 18] FIG. 18 is a diagram of an implantable device having one or more sensors, according to an embodiment of the present subject matter. [Figure 19] FIG. 19 is an illustration of an implantable device kit according to an embodiment of the present subject matter. [Figure 20] FIG. 20 is an illustration of joining a body lumen with an implantable device, according to an embodiment of the present subject matter. [Figure 21] FIG. 21 is an illustration of joining a body lumen with two implantable devices, according to an embodiment of the present subject matter. [Figure 22] FIG. 22 is an image showing two implantable devices implanted in a patient adjacent body lumens for joining the body lumens, according to an embodiment of the present subject matter. [Figure 23] FIG. 23 is an illustration of a single lumen implantable device and sensor probe, according to an embodiment of the present subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0007] The following detailed description of the present subject matter refers to subject matter in the accompanying drawings, which show, by way of illustration, specific aspects and embodiments in which the present subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. References in this disclosure to "an" embodiment, "one" embodiment, or "various" embodiments do not necessarily refer to the same embodiment, and such references contemplate multiple embodiments. 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 the appended claims, along with the full scope of legal equivalents to which such claims are entitled.

[0008] This specification describes, inter alia, systems and methods for monitoring the placement and / or adjustment of an implantable device for treating urinary incontinence. The implantable device may include, for example, an adjustable membrane element connected to a rear port by a conduit. The conduit has a lumen that provides fluid communication between a chamber of the adjustable membrane element and an internal cavity of the rear port. Each of the 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. An "adjustable membrane element" (e.g., adjustable membrane element 112 shown in FIG. 1) may be referred to, for example, as an adjustable element, an expandable element, an expandable membrane element, a forwardly expandable membrane element, a balloon, or an adjustable balloon. A "conduit" (e.g., conduit 114 shown in FIG. 1) may also be referred to, for example, as a central conduit element, a device conduit, a connecting conduit, a connecting conduit tube, or a tubular elongate body. A "rear port" (e.g., rear port 116 shown in FIG. 1) may also be referred to, for example, as a rear port portion or rear port element. A "lumen" (e.g., first lumen 215 and second lumen 217 shown in FIG. 2) may also be referred to, for example, as a passageway, inner passageway, or internal passageway.

[0009] In one example, the implantable device includes an adjustable balloon connected to a port by a conduit. The balloon is positioned adjacent to the urethra and applies non-circumferential compression to the urethral wall. The effectiveness of the treatment depends on proper placement of the balloon within the patient, such as in the retropubic space (resulting from a radical prostatectomy) near the urethral vesicostomy on the urogenital diaphragm adjacent to the urethral wall. When two balloons (e.g., two implantable devices) are used, their preferred placement is usually symmetrical and transverse to the urethra. Fluoroscopy or transrectal ultrasound can be used to visually monitor the position of the balloon during implantation of the implantable device. Fluoroscopy has become a standard technique, but it exposes the patient to radiation and provides a two-dimensional view that can be difficult to visualize in some situations. For example, when the patient is on the operating table, fluoroscopic images do not show the position of the balloon in the anterior-posterior plane and therefore do not indicate whether the balloon is properly positioned to apply compression to the urethral wall. Transrectal ultrasonography (TRUS) can provide a better view (e.g., the location of the balloon in the anterior-posterior plane), but the surgeon must be familiar with this imaging technique. During the implantation process, the implantable device is first placed in the patient with the balloon positioned in the target space. The balloon may be kept slightly inflated to allow encapsulation (by the patient's tissue) without migration from the target space. After encapsulation, the patient undergoes one or more adjustment procedures in which the balloon is adjusted to obtain and maintain urinary continence without causing undesirable obstruction.

[0010] The present subject matter uses one or more sensors incorporated into the implantable device and / or surgical instruments used to implant the implantable device to monitor placement and / or adjustment of the implantable device. This monitoring technique avoids the use of fluoroscopy or transrectal ultrasound and their drawbacks, such as exposure to X-rays or rectal insertion of an ultrasound probe. In one embodiment, the one or more sensors include one or more ultrasound transducers on the implantable device and / or on the surgical instrument to enable ultrasound imaging to be used to monitor balloon placement and adjustment during device implantation. An ultrasound sensor on the implantable device can further enable post-operative adjustment of the balloon.

[0011] In various embodiments, the present subject matter provides sensing means for monitoring, for example, the position of each balloon and the amount of inflation (distension) of each balloon. In various embodiments, the sensing means can be used to monitor various urethral conditions, which can indicate the amount of compression due to the degree of balloon inflation, such as excessive compression due to over-inflation of the balloon, adequate compression (target of treatment), and insufficient compression due to under-inflation of the balloon. The goal of treatment is to provide the patient with urinary continence free from unwanted obstruction, which requires the appropriate amount of urethral coaptation resulting from properly positioning the balloons and inflating each balloon by the appropriate amount. The present subject matter allows for the determination of the appropriate position and amount of inflation of each balloon.

[0012] FIGS. 1-10 illustrate various embodiments of implantable medical devices and surgical instruments. The surgical instrument includes an elongated body and can be used as a base device that can incorporate one or more sensors. The implantable medical device can be used with a surgical instrument that includes a sensor or can be used as a base device that can incorporate one or more sensors. Various embodiments of implantable devices and surgical instruments are illustrated in FIGS. 1-10 and described below by way of example, and not by way of limitation. These examples, as well as additional examples of implantable devices and surgical instruments, are described in U.S. Pat. Nos. 5,964,806, 6,045,498, 6,419,624, 6,579,224, and 8,926,494, which are assigned to Uromedica, Inc. and are incorporated herein by reference in their entireties. FIGS. 11-23 illustrate various embodiments of one or more sensors incorporated into implantable devices and / or surgical instruments as described herein.

[0013] In accordance with the present subject matter, as shown in FIG. 1 , an elongated implantable device 110 is provided that includes an adjustable membrane element 112, shown at its fully expanded size, and that is pressure-tightly attached to an elongated conduit 114. The conduit 114 is connected to a rear port 116 that communicates with the expandable element 112 via a first lumen 215 (see FIG. 2 ). The conduit 114 has a pointed front end 114A that extends slightly beyond the expandable element 112. A syringe 120, including a hollow needle 121 and a rear, axially movable plunger 122, is provided for adjustably injecting a suitable flowable material into the implantable device 110 via the rear port 116 to expand the adjustable membrane element 112.

[0014] As further shown in Figures 2 and 3, the conduit 114 includes two elongate lumens or passageways. A first lumen 215 provides an internal passageway through which flowable material is directed from a cavity 216A within 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. A second lumen 217 extends from a front opening 117A to a rear opening 117B and functions to receive an elongate guide probe (see Figure 4) and effect delivery of the implantable device 110 to a desired location in the patient's body tissue.

[0015] An important feature of the implantable device 110 having a first lumen 215 is the first open port 215A, which is disposed in the cavity 216A of the rear port 116 between the elastic septum 218 and the conduit 114 and is connected to the first lumen 215. Thus, a flowable material can be injected therethrough. The second port 215B functions to direct the working fluid toward the adjustable membrane element 112. During adjustment of the membrane fluid volume, a hollow needle 121 of the syringe 120 is injected through the septum 218 and passes through the conduit 114 connected to the adjustable membrane element 112. The rear port 116 preferably has a larger diameter than the conduit 114 to accommodate the cavity 216A and the septum 218. The septum 218 is securely held in place by a clamp ring 119.

[0016] The entire implantable device 110, including the adjustable membrane element 112, may be formed of a biocompatible material, such as a 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 may be integrally molded. As shown in FIG. 2, the adjustable membrane element 112 is adhered at its front end to the conduit tube 114 at 213 by a suitable adhesive.

[0017] Implantable devices and assemblies according to the present subject matter can include three main components. The first component provided is an elongate guide in the form of a rigid, solid, elongate guide probe 424 (see FIG. 4 ) configured to deliver the implantable device 110 to a desired location within a patient's body tissue, as generally shown in FIGS. 4 and 5 . Alternatively, the elongate guide member may be in the form of a flexible guidewire initially delivered to the body tissue via a separate, hollow, rigid probe inserted into the desired location within the body tissue. The second component of the assembly is the implantable device 110, which includes the adjustable membrane element 112, the conduit 114 including two lumens 215 and 217, and the rear port 116. During implantation, the elongate, solid guide probe 424 is first surgically inserted into the patient's body tissue to establish an initial pathway, after which the implantable device 110 is guided to a predetermined location adjacent a body lumen in the patient's body. The leading lumen opening 117A of the implantable device 110 is then positioned over the rear end of the guide probe 424 to guide the implantable device 110 and deliver the adjustable membrane element 112 (in its contracted configuration) to a predetermined location within the body tissue adjacent to the adjustably restricted body lumen. 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.

[0018] During implantation of the implantable device 110, a physician can first make a small incision in the patient's skin 430 near the body lumen 432 that needs to be restricted. Then, using visualization means such as fluoroscopy or ultrasound imaging, the solid guide probe 424 is directed to the desired location based on the patient's anatomy. The opening 117A of the second lumen 117 of the conduit 114, with the adjustable membrane element 112 in an initial contracted or deflated state, then slides over the rear end 424A of the guide probe 424. 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 between the adjustable membrane element 112 and the rear port 116. However, it may be advantageous to position the opening 117B near the adjustable membrane element 112 or to have the second lumen 217 extend through the rear port 116.

[0019] Optionally, markings 533 can be provided on guide probe 424 which, when aligned with features on implantable device 110, such as rear port 116, can ensure that implantable device 110 is properly placed at the correct depth in the patient's body tissue. To facilitate placement of septum 218 adjacent the patient's skin, it may be necessary to provide multiple lengths of conduit 114. Alternatively, the effective length of conduit 114 can be adjustable by having a helical shape similar to that of a coil spring.

[0020] After the implantable device 110 has been advanced over the guide probe 424 and the contracted adjustable membrane element 112 has been positioned at a desired location adjacent the body lumen 432, the body lumen 432 may 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 through the first lumen 215. The physician may determine the desired degree of restriction of the body lumen 432 by means such as injecting fluid through the body lumen beyond the restriction or measuring backpressure.

[0021] As shown in Figures 1 and 6, the source of the flowable material is typically a syringe 120 with a hollow needle used to pierce the elastic septum 218. However, alternative fluid containers with means for reversible connection to the implantable device 110 can be used. The flowable material may be, for example, saline, a flowable gel, or a slurry of particles in a liquid carrier. It may be advantageous to make the flowable material radiopaque so that the extent of membrane expansion can be seen by x-ray.

[0022] Another method of delivering the implantable device 110 is to first withdraw the guide probe 24 from the body tissue and then inflate the adjustable membrane element 112. Another alternative is to first position the implantable device 110 over the solid guide probe 424 outside the body and then insert them both as a unit into the body tissue. To facilitate this latter procedure, some friction between the solid guide probe 424 and the second lumen 217 in the conduit 114 may be desirable.

[0023] 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, the device is infused with a flowable material from a syringe 120. The expandable member is allowed to expand to a certain extent and then contract to a degree 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 in the body tissue. The skin incision 431 is then closed over the port 116 by means such as sutures 834, as shown in FIG. 8 .

[0024] The present subject matter provides implantable device 110 with adjustability for post-operative membrane expansion. This adjustability is achieved because septum 218 is separate from adjustable membrane element 112 but is located near and under the patient's skin. The port and septum are positioned, for example, by manual palpation of the skin area, and a syringe needle is inserted through the skin and septum to add or remove material from the expandable member, thereby increasing or decreasing the restriction of the body lumen.

[0025] To ensure proper sealing of the septum 218, a metal ring 119 is provided that surrounds the rear port 116 and is smaller and tighter in diameter than the port, so that it is placed in compression within the cavity 216A. When the needle 121 of the syringe 120 is withdrawn from the septum 218 after expansion or adjustment of the adjustable membrane element 112, a reliable seal exists around the septum 218.

[0026] 4-8 generally illustrate a 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 makes a small incision 431 and inserts a guide probe 424 into the body tissue at a desired location adjacent to the body lumen 432. This procedure is typically performed under local anesthesia with visual guidance by the physician, for example, under fluoroscopy. The physician then takes the implantable device 110 and positions it over the guide probe 424 via the second lumen 217, as shown in FIGS. 1 and 2 . The guide probe 424 enters the rear opening 117B and exits the front opening 117A. The implantable device 110, whose conduit 114 is sufficiently flexible, is advanced into the body tissue along the guide probe 424.

[0027] After reaching the desired location within the body tissue, as shown in FIG. 6 , 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. The guide probe 424 is then removed, and the adjustable membrane element 112 is further expanded to a desired expanded size due to the restriction of the body lumen 432. After the syringe 120 is removed from the implantable device 110, the desired size of the adjustable membrane element 112 is maintained by the elastic septum 218. The patient's incision at 431 is then surgically closed over the port 116 and the septum 218 with sutures at 834.

[0028] 9 is a diagram, showing 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 including a first lumen 915 extending longitudinally of the conduit 914 from a first opening 915A at a trailing end (also referred to as a proximal end) 962 to a second opening 915B, and the implantable device 910 is shown disposed within a channel 944 of a sheath 946.

[0029] Implantable device kit 940 further includes a rear port 916, which is connected to a rear end 962 of conduit 914. In one embodiment, rear port 916 is connected to rear end 962 of elongated body 914 using a chemical adhesive or using sonic welding techniques as known in the art. In an additional embodiment, rear port 916 and rear end 962 are formed together in a polymer molding process, such as liquid injection molding, as known in the art.

[0030] The rear port 916 includes a cavity 916A, which is in fluid communication with the first opening 915A of the conduit 914. In one embodiment, the rear port 916 includes a resilient septum 918 for accessing the cavity 916A, which is sealable, for example, even after repeated needle punctures. In one embodiment, the resilient septum 918 is retained in the rear port 916 by a clamp ring 919 disposed around the rear port 916. In one embodiment, the clamp ring 919 is formed of a biocompatible material, such as, for example, titanium. In one embodiment, the resilient septum 918 is formed of a biocompatible material, such as, for example, 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 rear port 916 has an outer diameter of 1 to 15 millimeters, with 4.5 millimeters being a specific example.

[0031] 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 interior size (e.g., diameter) of the channel 944 of the sheath 946 to allow the implantable device 910 to move longitudinally therethrough. In an alternative embodiment, the rear port 916 is constructed of at least one material that is sufficiently flexible to allow the size of the rear port 916 in a relaxed state to be compressed to a size small enough so that the implantable device 910 can be moved longitudinally through the channel 944 of the sheath 946. In various embodiments, the conduit 914 has sufficient rigidity to allow a force applied to the rear end of the tubular elongate body of the conduit 914 to at least partially move the implantable device 910 through the channel 944 of the sheath 946. In one embodiment, the rigidity of the conduit 914 is determined based on the type of material used in constructing the tubular elongate body of the conduit 914. Alternatively, a support element may 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.

[0032] Once the implantable device 910 is placed 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 includes a syringe with a non-coring needle, which is inserted through the elastic septum 918. A measured supply of fluid can be introduced into the implantable device 910, and the adjustable membrane element 912 will expand or contract due to the amount of flowable material introduced from the source into the cavity 916A of the rear port 916. The adjustable membrane element 912 is then used to at least partially and adjustably restrict the body lumen. Fluids suitable for injection into the prosthesis include, but are not limited to, sterile saline, polymer gels such as hydrogels or silicone gels made from polyvinylpyrrolidone, polyethylene glycol, or carboxymethylcellulose, high viscosity liquids such as hyaluronic acid, dextran, polyacrylic acid, polyvinyl alcohol, or radiopaque liquids. As the adjustable membrane element 912 expands, the needle is withdrawn from the septum of the rear port 916. In an additional embodiment, a detectable marker 970 is embedded in the continuous wall of the adjustable membrane element 912. The detectable marker 970 allows for the adjustable membrane element 912 to be located within the patient's tissue using any number of visualization techniques that use electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker 970 is comprised of tantalum, and the visualization technique used to visualize the adjustable membrane element 912 is x-ray or fluoroscopy, as known in the art.

[0033] In additional embodiments, 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 distal end) 960 (e.g., the tip) of the conduit 914. Alternatively, the detectable marker may be located on the continuous wall of the adjustable membrane element 912. The detectable marker 970 allows the leading end 960, i.e., the adjustable membrane element 912, to be located within the patient's tissue using any number of visualization techniques that use electromagnetic energy as a means of identifying objects within the body. In one embodiment, the detectable marker 970 is comprised of tantalum, and the visualization technique used to visualize the leading end 960, i.e., the adjustable membrane element 912, is x-ray or fluoroscopy, as known in the art. In additional embodiments, the sheath can have a detectable marker, which can be incorporated into or on the wall of the sheath. Alternatively, the entire sheath can be configured to be radiopaque.

[0034] 10 is a diagram of an additional 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 periphery of the conduit 1014 is connected to and sealed to the adjustable membrane element 1012. In one embodiment, the adjustable membrane element 1012 includes a continuous wall having an inner surface that defines a chamber.

[0035] The conduit 1014 includes 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 are in fluid communication with a chamber of the adjustable membrane element 1012 for adjustably expanding or contracting the adjustable membrane element 1012 with a flowable material introduced through the first opening 1015A.

[0036] Second lumen 1017 extends longitudinally along conduit 1014 from inlet 1017B to closed end 1017A at front end 1060. In one embodiment, second lumen 1017 and inlet 1017B are each of sufficient diameter to receive a push rod that can be used to advance implantable device 1010 within tissue.

[0037] The implantable device 1010 further includes a rear port 1016 connected 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 an elastic septum 1018. The cavity 1016A is connected to and in fluid communication with the first lumen 1015 at a first opening 1015A. The elastic septum 1018 allows overflow into the cavity 1016A using a needle to introduce and / or withdraw fluids to expand and / or extract the adjustable membrane element 1012.

[0038] FIG. 11 is a top view of a bladder 1101 and a urethra 1102 showing an approximate target site for placement of an implantable device 1110 to improve urethral coaptation, according to an embodiment of the present subject matter. The implantable device 1110 (with an expandable or adjustable membrane element shown in the figure to indicate its location) may represent any embodiment of an implantable device as described herein, including, but not limited to, implantable device 110, implantable device 910, implantable device 1010, or implantable devices including various combinations of features of implantable devices 110, 910, and 1010. A Cartesian coordinate system with X, Y, and Z axes is shown in FIGS. 11-21 as an example directional reference for the structures shown in FIGS. 11-21 (two of the X, Y, and Z axes are shown in each of these figures). The direction of the Z axis is along the direction of the urethra 1002 at the approximate location of implantation. The location is near the bladder neck and urethrovesical anastomosis in the case of radical prostatectomy, or further down the urethra at the apex of the prostate after transurethral resection of the prostate (TURP).

[0039] 12 is a view along the length of the urethra 1102 (or along the Y-axis) in the implantation region showing approximate target sites for placement of an implantable device 1110 to improve urethral coaptation, according to embodiments of the present subject matter. The present subject matter can assist in proper placement of the implantable device 1110 during implantation in a patient and / or adjustment of the implantable device 1110 after implantation. In particular, accurate placement of the implantable device 1110 along the Y-axis (sagittal view) is facilitated by application of the present subject matter.

[0040] 13 is a diagram of an implantable device kit 1320 including an implantable device 1310 and a sensor probe 1324, according to an embodiment of the present subject matter. The implantable device 1310 and the sensor probe 1324 may be provided as a device kit, which may include other accessories. The implantable device 1310 may be used to join a body lumen and may include an adjustable membrane element 1312, an elongate conduit 1314, and a rear port 1316. The adjustable membrane element 1312 is configured to join the lumen and includes a continuous wall having an inner surface that defines a chamber. The conduit 1314 has a rear end 1315, a front end 1313 connected to the adjustable membrane element, a periphery connected to and sealed to the adjustable membrane element near the front end 1313, and a lumen (not shown in FIG. 13 ) extending longitudinally within the conduit from a first opening at the rear end 1315 to a second opening located at or near the front end 1313 and in fluid communication with the chamber. A rear port 1316 is connected to the rear end 1315 and includes a cavity in fluid communication with the first opening of the first lumen and a resilient septum that allows access to the cavity by a needle. In some embodiments, the rear port 1316 is releasably connected to the rear end of the conduit 1314. Implantable device 1310 may represent any embodiment of an implantable device as described herein, including, but not limited to, implantable device 110, implantable device 910, implantable device 1010, or an implantable device including various combinations of features of implantable devices 110, 910, and 1010.

[0041] The sensor probe 1324 has an elongate body 1326 having a trailing end 1327 and a leading end 1325, and one or more sensors 1328 integrated into the elongate body 1326. In various embodiments, the sensor probe 1324 may be configured by incorporating the sensor 1328 into any surgical instrument having an elongate body used during implantation and / or adjustment of the implantable device 1310. Examples of such surgical instruments include push rods (e.g., push rod 1450) and guide probes (or guide rods or guide wires, e.g., guide probe 424). In one embodiment, as shown in FIG. 13 , one sensor 1328 is shown at the leading end 1325. In another embodiment, multiple sensors 1328 are distributed throughout at least a portion of the elongate body 1326, as shown in FIG. 14 , which illustrates a portion of a sensor probe 1424 according to an embodiment of the present subject matter.

[0042] In various embodiments, the sensor 1328 can be rotated by rotating the elongated body 1326, such as by rotating the rear end 1327. The elongated body 1326 can include a sensor connection circuit 1330, such as at the rear end 1327. A conductor 1329 extends within the elongated body 1326 to provide a connection between the sensor 1328 and the sensor connection circuit 1330. In one embodiment, the sensor connection circuit 1330 includes a connector for connecting to an external system that processes signals sensed by the sensor 1328. In another embodiment, the sensor connection circuit 1330 includes a telemetry circuit and a battery to enable wireless communication with the external system. The telemetry circuit can perform wireless communication using, for example, electromagnetic, magnetic, acoustic, or optical telemetry.

[0043] In various embodiments, the sensor 1328 can include one or more ultrasound transducers for converting an electrical input signal into ultrasound, transmitting ultrasound, receiving reflected ultrasound (echoes of the transmitted ultrasound), and converting the received reflected ultrasound into electrical image signals. An external system can receive the electrical image signals and generate an ultrasound image based on the electrical image signals. The one or more ultrasound transducers can each include a piezoelectric transducer or a capacitive transducer, each having an ultrasound beam direction and an ultrasound beam angle.

[0044] In various embodiments, sensor 1328 may include one or more optical sensors. Each of the one or more optical sensors may include a charge-coupled device (CCD) image sensor or an active pixel sensor (APS, also known as a complementary metal-oxide semiconductor (CMOS) image sensor) to convert a captured image into an electrical image. An external system may receive the electrical image signals and generate a visual image based on the electrical image signals.

[0045] In various embodiments, a lumen of the implantable device 1310 in fluid communication with the chamber is configured to receive a sensor probe 1324 used as a push rod (e.g., as shown in FIG. 9 ). The end of the lumen at the front end 1313 is configured to receive a force applied via the sensor probe 1324 to move the implantable device 1310. The lumen includes a closed end near the front end 1313. The closed end has sufficient strength and rigidity to receive the front end 1325 of the sensor probe 1324 and to transmit a force applied to the rear end 1327 of the sensor probe to the implantable device 1310.

[0046] In various other embodiments, the first lumen of the implantable device 1310 is in fluid communication with the chamber to adjust the volume of the chamber, and the implantable device 1310 includes a second lumen extending longitudinally within at least a portion of the conduit 1314 and configured to receive a sensor probe 1324 (e.g., as shown in FIGS. 2, 3, 5, and 10). The second lumen includes an inlet at or near the rear end 1315 of the conduit 1314 and an outlet at or near the front end 1313 of the conduit 1314. The front end 1313 is configured to receive a force applied via the sensor probe 1324 to move the implantable device 1310.

[0047] In one embodiment, the second lumen includes a closed end near the forward end 1313 of the conduit 1314. This closed end has sufficient strength and rigidity to receive the forward end 1325 of the sensor probe 1324 and transmit forces applied to the rear end 1327 of the sensor probe to the implantable device 1310. FIG. 16 is a cross-sectional view of a portion of the forward end 1613 of the elongate conduit 1614, illustrating the closed end of a first or second internal passage configured to receive forces applied via the sensor probe 1324 to move the implantable device 1310, according to an embodiment of the present subject matter. The forward end 1613 may represent an example of a forward end 1313. In one embodiment, the forward end 1613 includes a sensor window 1635 to provide transparency to sensed signals. For example, an ultrasound-transparent material may be used for the sensor window 1635. The sensor window 1635 may be configured for a specified overall ultrasound beam angle up to 360 degrees (ie, the sensor window has a length equal to the circumference of the second lumen).

[0048] In another embodiment, the sensor probe 1324 includes a sharp tip suitable for penetrating tissue, such as the example shown in FIG. 10. FIG. 15 illustrates a front end 1525 of a sensor probe 1524, according to one embodiment of the present subject matter. The sensor probe 1524 may represent an example of a sensor probe 1324 and includes a sharp tip 1531 at the front end 1525. The second lumen includes an outlet near the front end 1313 of the conduit 1314. The outlet allows a portion of the sensor probe 1524, including the sharp tip 1531, to protrude from the conduit 1314. FIG. 17 illustrates a cross-sectional view of a portion of the front end 1713 of an elongate conduit 1714, according to an embodiment of the present subject matter. The front end 1713 may represent an example of a front end 1313. The second lumen includes a first shoulder 1736, and the sensor probe 1524 includes a second shoulder 1532 configured to abut the first shoulder 1736 to allow a force applied to the rear end 1327 of the sensor probe 1324 to be transferred to the implantable device 1310. In one embodiment, as shown in FIGS. 15 and 17 , the first shoulder 1736 is formed by a change in diameter of the second lumen, and the second shoulder 1532 is formed by a change in diameter of the sensor probe 1524. The sensor 1328 can be integrated into the elongate body 1526 of the sensor probe 1524 at the front end 1525 such that both the sharp tip 1531 and the sensor 1328 can protrude from the conduit 1314 of the implantable device 1310.

[0049] 18 is a diagram of an implantable device 1810 having one or more sensors, according to an embodiment of the present subject matter. The implantable device 1810 includes an implantable device 1310 as described above and one or more sensors 1828 incorporated into the implantable device 1310. The implantable device 1810 further includes a sensor connection circuit 1840, such as at the rear end 1315, and conductors 1841 extending within the elongated body 1314 to provide a connection between the sensors 1828 and the sensor connection circuit 1840. In the illustrated embodiment, the implantable device 1810 includes six sensors 1828 at the distal connection locations between the adjustable membrane element 1312 and the conduit 1314, at the infrequent connection locations between the adjustable membrane element 1312 and the conduit 1314, and at locations along the centerline of the adjustable membrane element 1312 (perpendicular to the conduit, i.e., perpendicular to the Z-axis). In various embodiments, any number of sensors are incorporated anywhere on the implantable device 1810. For example, one or more sensors 1828 may be incorporated in the conduit 1314 (e.g., at or adjacent the front end 1313, at or adjacent the distal connection between the adjustable membrane element 1312 and the conduit 1314, and / or at or adjacent the rear connection between the adjustable membrane element 1312 and the conduit 1314) and / or the adjustable membrane element 1312 (e.g., on a centerline of the adjustable membrane element 1312 perpendicular to the conduit 1314, adjacent the distal connection between the adjustable membrane element 1312 and the conduit 1314, and / or adjacent the rear connection between the adjustable membrane element 1312 and the conduit 1314).

[0050] In various embodiments, the sensor 1828 can include one or more ultrasound transducers for converting electrical input signals into ultrasound, transmitting ultrasound, receiving reflected ultrasound (echoes of the transmitted ultrasound), and converting the received reflected ultrasound into electrical image signals. An external system can receive the electrical image signals and generate an ultrasound image based on the electrical image signals. The one or more ultrasound transducers can each include a piezoelectric or capacitive transducer, each having an ultrasound beam direction and an ultrasound beam angle. Multiple ultrasound transducers can be arranged on the implantable device 1810 to provide a specified overall ultrasound beam angle (e.g., 90, 180, 270, or 360 degrees).

[0051] In various embodiments, the sensor 1828 can include one or more optical sensors. Each of the one or more optical sensors can include a CCD image sensor or an APS to convert the captured image into an electrical image. An external system can receive the electrical image signals and generate a visual image based on the electrical image signals.

[0052] In various embodiments, the sensors 1828 may include one or more of any type capable of sensing signals useful in assisting in the placement and adjustment of the implantable device 1810, such as pressure sensors and strain gauges.

[0053] The sensor connection circuit 1840 may be within the rear port 1316 and provides access to one or more sensors 1828 via the rear port 1316. In one embodiment, the implantable device 1810 can communicate with an external system using a wired connection. The sensor connection circuit 1840 includes a connector. The external system includes a percutaneous connector that penetrates the elastic septum of the rear port 1316 and mates with a connector at the rear port 1316. In another embodiment, the implantable device 1810 can communicate with the external system wirelessly. The sensor connection circuit 1840 includes telemetry circuitry and a battery or inductive power receiver. The telemetry circuit can transmit power to the implantable device 1810 and receive sensed signals from the implantable device 1810.

[0054] 19 is a diagram of an implantable device kit 1920 according to an embodiment of the present subject matter. The implantable device kit, as shown in FIG. 19 , includes at least an implantable device 1810 and a sensor probe 1324, as well as other instruments or accessories used in the implantation of the implantable device 1810. The sensor 1828 and one or more sensors selected from the sensor 1328 can be used to provide monitoring of the implantable device 1810 during implantation and / or adjustment. For various purposes and situations, a user may use only one or more of the implantable devices 1810, only one or more sensors of the sensor probe 1324, or sensors of both the implantable device 1810 and the sensor probe 1324 for monitoring.

[0055] 20 is a diagram of joining of a body lumen 1102 with an implantable device 2010 and a probe 2024, in accordance with an embodiment of the present subject matter. Examples of implantable device 2010 include, but are not limited to, any of the implantable devices described herein (with or without one or more sensors), such as implantable devices 110, 910, 1010, 1310, and 1810. Examples of probe 2024 include, but are not limited to, any of the probes described herein (with or without one or more sensors), such as guide probe 424, push rod 1450, and sensor probes 1324, 1424, and 1524. Sensor 2028 represents any one or more sensors incorporated into implantable device 2010 and / or probe 2024. In one embodiment, the sensor 2028 provides an image, such as that shown in FIG. 22, to guide placement of the implantable device 2010 adjacent the lumen 1102 (e.g., the urethra) for joining the lumens and / or to enable determination of whether the body lumen has been joined to a desired degree.

[0056] FIG. 21 is a diagram of the coaptation of a body lumen 1102 using an implantable device 2010 and two probes 2204, in accordance with an embodiment of the present subject matter. FIG. 22 shows an example of an image of this treatment. When the body lumen (e.g., the urethra) is properly coapted, flattening of the adjustable membrane element 1312 of each implantable device facing the body lumen is observed. In various embodiments, the sensor 2028 can be used to provide an image of the position of each of the multiple implantable devices 2010 and / or other information indicative of the position, an image of the degree of flattening of the adjustable membrane element 1312 and / or other information indicative of the degree of flattening, and / or an image of the shape of the body lumen and / or other information indicative of the shape of the body lumen, thereby providing guidance in positioning and / or adjusting the implantable device 2010. The shape of the body lumen can indicate the degree of coaptation of the body lumen. In various embodiments, sensors 2028 disposed on each of the implantable devices 2010 can detect information indicative of the shape of the adjustable membrane element 1312 of the same implantable device, information indicative of the position (e.g., position relative to the body lumen 1102) of the adjustable membrane element 1312 of the same implantable device, information indicative of the shape of the adjustable membrane element 1312 of other implantable devices 2010, information indicative of the position (e.g., position relative to the body lumen 1102) of the adjustable membrane element 1312 of other implantable devices 2010, and / or information indicative of the shape and / or position of another implantable device or portion thereof present in tissue near the implantable device 2010.

[0057] 23 is a diagram of an implantable device kit 2320 including a single-lumen implantable device 2310 and a sensor probe 2324, according to an embodiment of the present subject matter. The implantable device kit 2320 may represent one example of the implantable device kit 1320, in which the implantable device 2310 is used for urethral coaptation and the sensor probe 2324 is used to detect one or more indicators of the state or degree of urethral coaptation and to adjust the volume of the adjustable membrane element 2312 of the implantable device 2310 for optimal effectiveness in treating urinary incontinence without causing urethral obstruction. The implantable device 2310 includes a front end 2360, a rear port 2316, and an elongated conduit 2314 connected between the front end 2360 and the rear port 2316. The adjustable membrane element 2312 is secured to the conduit 2314 near the front end 2360 and includes a continuous wall having an inner surface defining a chamber. The lumen 2315 extends longitudinally within the conduit 2314 and is in fluid communication with the chamber of the adjustable membrane element 2312 at the distal opening 2315B and with the cavity 2316A of the rear port 2316 at the rear opening 2315A. In the illustrated embodiment, the sensor probe 2324 is a three-in-one device that can also be used as: (1) a sensing device including a sensor 2328 at the front end of the sensor probe 2324, (2) a push rod for advancing the implantable device 2310 within tissue by applying force at the front end 2360 against the closed front end of the lumen 2315, and (3) a needle including a lumen 2365 through which fluid is admitted and withdrawn for inflation and deflation of the adjustable membrane element 2312, respectively, through the distal opening 2315B of the lumen 2315. The lumen 2315 is configured to receive the front of the sensor probe 2324 such that the front end of the sensor probe 2324 reaches the closed front end of the lumen 2315. As shown in FIG. 23 , when the adjustable membrane element 2312 is positioned adjacent the urethra and inflated, pressure from the urethra can flatten the sides of the adjustable membrane element 2312. The sensor 2328 allows for observation of such flattening, which indicates the amount of pressure that can be adjusted for optical effectiveness in treating urinary incontinence.

[0058] As shown in FIG. 23 , the adjustable membrane element 2312 has a flat portion that expands to provide urethral coaptation and resists expansion from the urethra. The implantable device 2310 includes a radiopaque marker 2370 at the leading end 2360. The radiopaque marker 2370 serves as a stop for the sensing probe 2324 to ensure that the sensing probe 2324 is in the correct position for sensing. The stop also serves as a stop for a push rod (e.g., the sensor probe 2324 used as a push rod) for positioning the implantable device 2310 during the first implantation procedure. When the sensor probe 2324 is used as a push rod, the placement and / or initial adjustment of the implantable device 2310 can be guided using the sensor 2328 to observe urethral coaptation. The rear port 2316 includes a self-closing septum 2318 to allow access to the lumen 2315 by the sensor probe 2324 (and other push rods or push wires, if used). The front end of the sensor probe 2324 has a sharp tip for penetrating the septum 2318. Advantages of a single lumen implantable device include providing more cross-sectional area to accommodate the sensor 2328 within a conduit 2314 of a given diameter.

[0059] In the illustrated embodiment, the sensor 2328 is an optical sensor for visually observing the flattening of the adjustable membrane element 2312 relative to the urethra as a surrogate for actual visualization of the coaptation within the urethra. In another embodiment, the sensor 2328 is an ultrasound sensor. In addition to directly observing the coaptation of the urethra, if the ultrasound sensor transmits ultrasound with sufficient penetration depth into tissue, it may also allow visualization of the adjustable membrane element 2312 in relation to anatomical structures such as the bladder neck and rectum. Such visualization can be used to aid in the placement of the adjustable membrane element 2312 during implantation of the implantable device 2310. In various embodiments, the sensor 2328 may include any type of sensor that allows detection of the flattening of the adjustable membrane element 2312 within tissue and / or visualization of the adjustable membrane element 2312 in relation to various anatomical structures.

[0060] In the illustrated embodiment, the sensor 2328 (i.e., optical sensor) includes an optical sensing element 2361 for observing the flattening of the adjustable membrane element 2312 using a CCD or CMOS chip 2362 that obtains a radial view using a mirror 2363. Power is supplied to the chip 2362, and data obtained by the sensor 2328 is returned via a filament 2364. The filament 2364 can be used to power a light source, such as an LED, to aid in visualization (this is not necessary if the chip 2362 is an infrared CCD or CMOS chip). The sensor probe 2324 can rotate about its longitudinal axis within the lumen 2315 to scan circumferentially to find the maximum juncture point where the adjustable membrane element 2312 is flattened. Rotating the sensor probe 2324 can aid in negotiating curves within the conduit 2314, especially if the rear port 2316 is wired to the scrotum or labia. For at least this reason, the sensor probe 2324 is provided with some flexibility. In one embodiment, the sensor probe 2324 with optical sensor 2328 is provided with a wide angle lens so that it can view the entire inner surface of the adjustable membrane element 2312 so that circumferential scanning is not required.

[0061] In another embodiment, the sensor probe 2324 may include a borescope for optical visualization with a fiber optic bundle extending through the sensor probe. The fiber can also be used to transmit light from a light source externally connected to the sensor probe, eliminating the need for a light source within the sensor probe 2324. The fiber optic bundle has a substantially smaller diameter when compared to the size of a CCD or CMOS chip, thereby reducing the diameter of the sensor probe 2324 and, therefore, the diameter of the conduit 2314 and rear port 2316. This allows for a reduction in the overall size of the implantable device 2310 and the overall size of the sensor probe 2328. A smaller diameter is desirable because the sensor probe 2324 must pass through the skin of the scrotum or labia to reach the rear port 2316 of the implantable device 2310 after implantation in the patient. Furthermore, fiber optic implementation of the sensor probe 2324 may reduce manufacturing costs when compared to optical sensor implementations using CCD or CMOS chips, thereby improving the affordability of manufacturing the sensor probe 2324 as a disposable device.

[0062] This application is intended to cover any adaptations or variations of the present subject matter. It is to be understood that the above description is intended to be illustrative, and not limiting. 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 kit capable of controlling the degree of closure of a body lumen in living tissue, comprising: Two implantable devices, each of the implantable devices comprising: an adjustable membrane element configured to close the body lumen, the membrane element including a continuous wall having an inner surface defining a chamber; an elongate conduit including a conduit periphery, a conduit rear end, a conduit front end, and a conduit lumen, the conduit periphery being connected and sealed to the adjustable membrane element at or near the conduit front end, the conduit lumen having a first opening located at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end; a rear port connected to the rear end of the conduit and including a cavity in fluid communication with the first opening of the conduit lumen; two implantable devices, two sensor probes configured to be partially disposed on two of the implantable devices, each of the sensor probes comprising: a probe front end having a sharp tip configured to penetrate the rear port of a corresponding implantable device to enter the conduit lumen of the implantable device and reach the closed end of the conduit lumen; a sensor configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, and a shape of the body lumen; two sensor probes, wherein each of the two implantable devices is configured to be implanted in the tissue with the adjustable membrane element adjacent to the body lumen.

2. 2. The implantable device kit of claim 1, wherein each of the two sensor probes has a probe lumen configured to be in fluid communication with the chamber of the adjustable membrane element of the corresponding implantable device, and when the probe front end is positioned within the conduit lumen of the corresponding implantable device at the closed end of the conduit lumen, introducing fluid into the chamber through the probe lumen allows expansion of the adjustable membrane element, and expelling fluid from the chamber through the probe lumen allows contraction of the adjustable membrane element.

3. 3. The implantable device kit of claim 1, wherein each of the two sensor probes is configured to be used as a push rod for advancing the corresponding implantable device within the tissue during implantation of the implantable device.

4. The implantable device kit of claim 1 , wherein the sensor comprises an optical sensor.

5. The implantable device kit of claim 1 , wherein the sensor comprises an ultrasonic sensor.

6. The implantable device kit of claim 1 , wherein the conduit front end comprises a sensor window that transmits signals received by the sensor when the sensor is positioned within the conduit lumen.

7. The implantable device kit of claim 1 , wherein the sensor is configured to detect information indicative of a shape of the body lumen, the shape indicating a degree of occlusion of the body lumen.

8. An implantable device kit capable of controlling the degree of closure of a body lumen in living tissue, comprising: two sensor probes, each of the sensor probes including a probe front end and a sensor integrated into the probe front end; Two implantable devices, each of the implantable devices comprising: an adjustable membrane element configured to close the body lumen, the membrane element including a continuous wall having an inner surface defining a chamber; an elongate conduit including a conduit periphery, a conduit rear end, a conduit front end, a first conduit lumen, and a second conduit lumen, the conduit periphery connected and sealed to the adjustable membrane element at or near the conduit front end, the first conduit lumen having a first opening at the conduit rear end and a second opening in fluid communication with the chamber, the second conduit lumen having an inlet configured to receive a portion of the sensor probe including the probe front end and a closed end at or near the conduit front end and configured to allow the probe front end to advance into the closed end; a rear port connected to the rear end of the conduit and including a cavity in fluid communication with the first opening of the first conduit lumen; two implantable devices, the sensor is configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, and a shape of the body lumen; An implantable device kit, wherein each of the two implantable devices is configured to be implanted in the tissue with the adjustable membrane element adjacent to the body lumen.

9. 9. The implantable device kit of claim 8, wherein each of the two sensor probes is configured to be used as a push rod for advancing the corresponding implantable device within the tissue during implantation of the implantable device.

10. The implantable device kit of claim 8 or 9, wherein the sensor comprises an optical sensor.

11. The implantable device kit of claim 10 , wherein the optical sensor comprises a camera.

12. The implantable device kit of claim 10 , wherein the optical sensor comprises a fiber optic borescope.

13. The implantable device kit of claim 8 or 9, wherein the sensor comprises an ultrasonic sensor.

14. 14. The implantable device kit of claim 8, wherein the conduit front end comprises a sensor window that transmits signals received by the sensor when the sensor is positioned within the second conduit lumen.

15. 14. The implantable device kit of claim 8, wherein the second conduit lumen has an outlet at or near the forward end of the conduit, the outlet allowing the forward end of the probe including the sensor to protrude from the elongate conduit.

Images