Implantable device kit and implantable device for controllable engagement of a body luminal in a tissue of a living body

Abstract

The invention relates to an implantable device kit and an implantable device for controllable engagement of a body lumen in a tissue of a living body. An implantable device kit for controllable engagement of a body lumen in a tissue of a living body includes two implantable devices, each implantable device including: an adjustable membrane element including a continuous wall having an inner surface defining a chamber, the adjustable membrane element configured to engage the body lumen; an elongate catheter comprising a catheter peripheral surface connected to and sealed to the adjustable membrane element at or near the catheter front end, a catheter rear end, a catheter front end, and a catheter lumen, the catheter lumen has a first opening at the catheter rear end, a second opening in fluid communication with the chamber, and a closed end at or near the catheter front end; and a posterior port wherein the two implantable devices are each configured to be implanted in tissue wherein the adjustable membrane element is adjacent a body lumen.

Description

[0001] This application is a divisional application of the application with national application number 202080028548.0, international application date February 14, 2020, national entry date October 13, 2021, and invention name “Device for monitoring an implantable device for urinary continence”.

[0002] Claiming priority

[0003] This application claims the benefit of priority to U.S. patent application serial number 16 / 450,246, filed on June 24, 2019, which claims the benefit of priority to U.S. provisional application serial number 62 / 805,503, filed on February 14, 2019, the disclosures of each of which are incorporated herein by reference in their entirety. Technical Field

[0004] This document 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 Art

[0005] The example of the implantable device for treating urinary incontinence includes an adjustable membrane element such as a balloon connected to the rear port by a catheter. The implantable device can be implanted in the patient's body by minimally invasive surgery, wherein the adjustable membrane element is placed adjacent to the patient's urethra and the rear port is placed under the patient's skin. The adjustable membrane element can be adjusted during and after the operation by injecting fluid into the rear port or extracting fluid percutaneously from the rear port using a needle. In an exemplary treatment, two of this implantable device are placed in the patient's body so that two adjustable membrane elements provide pressure and support at the patient's bladder neck to prevent the accidental leakage of urine during sneezing, coughing or physical activity. The effect of this treatment depends on the appropriate placement in the patient's body and the adjustment of the adjustable membrane element after the placement. Summary of the invention

[0006] One or more sensors are incorporated into the implantable device and one or more of the surgical tools for placement and / or adjustment of the implantable device. The implantable device includes an adjustable membrane element for controllable engagement of a body lumen, such as engagement of the urethra, as a treatment for urinary incontinence. In various embodiments, the one or more sensors can be configured to detect information indicating at least one of the shape of the adjustable membrane element, the position of the adjustable membrane element relative to the body lumen, or the shape of the body lumen.

[0007] In various embodiments, an implantable device for controllable engagement of a body lumen may include an adjustable membrane element and an elongated catheter. The adjustable membrane element may include a continuous wall having an inner surface defining a chamber. The elongated catheter may include an inner cavity that is connected to and sealed to the peripheral surface of the adjustable membrane element, a rear end, a front end, and a first opening at the rear end in the elongated catheter that extends longitudinally to a second opening that is in communication with the chamber fluid of the implantable device, for adjustably expanding or contracting the adjustable membrane element by the applied flowable material introduced via the first opening. One or more sensors may be incorporated into the implantable device and / or the sensor probe for monitoring the positioning of the implantable device, the adjustment of the implantable device, and / or the engagement state of the body lumen. In one embodiment, one or more sensors are incorporated into at least one of the adjustable membrane element or the elongated catheter of the implantable device. In another embodiment, the sensor probe includes a front end into which a sensor is incorporated. In one embodiment, the inner cavity of the elongated catheter 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 in the elongated catheter and having: an inlet configured to receive a portion of the sensor probe; and a closed end for stopping the sensor probe; or an outlet configured to allow exit of a portion of the sensor probe including its leading end. In various embodiments, the one or more sensors may include one or more optical sensors such as a camera or borescope, and / or one or more ultrasonic transducers for generating ultrasonic images.

[0008] According to one embodiment of the present disclosure, there is provided an implantable device kit for controllable engagement of a body cavity in a living body's tissue, comprising: two implantable devices, each implantable device comprising: an adjustable membrane element, the adjustable membrane element comprising a continuous wall having an inner surface defining a chamber, the adjustable membrane element being configured to engage the body cavity; an elongated catheter, the elongated catheter comprising a catheter peripheral surface, a catheter rear end, a catheter front end, and a catheter lumen, the catheter peripheral surface being connected to and sealed to the adjustable membrane element at or near the catheter front end, the catheter lumen having a first opening at the catheter rear end, a second opening in fluid communication with the chamber, and a closed end at or near the catheter front end; and a rear port, the rear port being connected to the catheter rear end and comprising a closed end in communication with the catheter front end. a cavity connected to the first opening fluid of the tube cavity; and two sensor probes, each sensor probe is configured to be partially placed in one of the two implantable devices, and each sensor probe includes: a probe front end, the probe front end has a sharp tip, and is configured to enter the catheter cavity of the one implantable device and reach the closed end of the catheter cavity by piercing the rear port of the one implantable device; and a sensor, the sensor is configured to detect information indicating at least one of the shape of the adjustable membrane element, the position of the adjustable membrane element relative to the body cavity, or the shape of the body cavity, wherein the two implantable devices are each configured to be implanted in the tissue, wherein the adjustable membrane element is adjacent to the body cavity.

[0009] According to one embodiment of the present disclosure, there is provided an implantable device kit for controllable engagement of a body cavity in tissue of a living body, comprising: two sensor probes, each sensor probe comprising a probe front end and a sensor incorporated into the probe front end, the sensor being configured to detect information indicating the degree of engagement of the body cavity; and two implantable devices, each implantable device comprising: an adjustable membrane element, the adjustable membrane element comprising a continuous wall having an inner surface defining a chamber, the adjustable membrane element being configured to engage the body cavity; an elongated catheter, the elongated catheter comprising a catheter outer surface, a catheter rear end, a catheter front end, a first catheter lumen, and a second catheter lumen, the catheter outer surface being adjustable at the catheter front end. The first catheter lumen has a first opening at the rear end of the catheter and a second opening in fluid communication with the chamber, the second catheter lumen has: an inlet configured to receive a portion of the sensor probe including the front end of the probe; and a closed end at or near the front end of the catheter, and the second catheter lumen is configured to allow the front end of the probe to be advanced to the closed end; and a rear port connected to the rear end of the catheter and including a cavity in fluid communication with the first opening of the first catheter, wherein the two implantable devices are each configured to be implanted in the tissue, with the adjustable membrane element adjacent to the body lumen.

[0010] According to one embodiment of the present disclosure, an implantable device is provided, which is configured to be implanted in body tissue adjacent to a body cavity for controllable engagement with the body cavity, the implantable device comprising: an adjustable membrane element, the adjustable membrane element comprising a continuous wall having an inner surface defining a chamber; an elongated catheter, the elongated catheter comprising: a catheter outer peripheral surface connected to and sealed to the adjustable membrane element; a catheter rear end; a catheter front end; and a catheter lumen, the catheter lumen extending longitudinally in the catheter from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device to adjustably expand or contract the adjustable membrane element by a flowable material introduced through the first opening; and one or more sensors, the one or more sensors being incorporated into at least one of the adjustable membrane element or the elongated catheter and being configured to detect information indicating at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body cavity.

[0011] According to one embodiment of the present disclosure, there is provided an implantable device kit for controllable engagement of a body cavity in a living body tissue, the implantable device kit comprising: an implantable device, the implantable device being configured to control engagement of the body cavity, the implantable device comprising: an adjustable membrane element, the adjustable membrane element comprising a continuous wall having an inner surface defining a chamber; an elongated catheter, the elongated catheter comprising: a catheter peripheral surface connected to and sealed to the adjustable membrane element; a catheter rear end; a catheter front end; a first catheter lumen, the first catheter lumen extending longitudinally in the catheter from a first opening at the rear end to a second opening in fluid communication with the cavity of the implantable device, so as to control engagement of the body cavity by a fluid passing through the catheter. The adjustable membrane element is adjustably expanded or contracted by a flowable material introduced into the first opening; and a second catheter lumen, which extends longitudinally in the catheter from an inlet on the catheter and an end at or near the front end of the catheter; a sensor probe, the sensor probe including a probe front end, the probe front end is configured to enter the inlet of the second catheter lumen and reach the end of the second catheter lumen through the second catheter lumen; and a plurality of sensors, which are incorporated into the implantable device and the sensor probe and are configured to detect information indicating at least one of the shape of the adjustable membrane element, the position of the adjustable membrane element, or the shape of the body lumen.

[0012] According to one embodiment of the present disclosure, there is provided an implantable device kit for controllable engagement of a body cavity in tissue of a living body, comprising: a sensor probe, the sensor probe comprising a probe front end and a sensor incorporated into the probe front end, the sensor being configured to detect information indicating the degree of engagement of the body cavity; and an implantable device, the implantable device comprising: an adjustable membrane element, the adjustable membrane element comprising a continuous wall having an inner surface defining a chamber, the adjustable membrane element being configured to engage the body cavity; an elongated catheter, the elongated catheter comprising a catheter peripheral surface, a catheter rear end, a catheter front end, a first catheter lumen and a second catheter lumen, the catheter peripheral surface being connected to and sealed to the adjustable membrane element at or near the catheter front end, the first catheter lumen having a first opening at the catheter rear end and a second opening communicating with the chamber fluid, the second catheter The inner cavity is configured to receive a portion of the sensor probe including the front end of the probe and allow the front end of the probe to be advanced to a position at or near the front end of the catheter for the sensor to receive a signal including information to be detected, the second catheter inner cavity including an inner cavity shoulder; and a rear port, the rear port is connected to the rear end of the catheter and includes a cavity in fluid communication with the first opening of the first catheter, wherein the second catheter inner cavity includes: an outlet at or near the front end of the catheter, the outlet allows the front end of the probe including the sensor to protrude from the elongated catheter, wherein the sensor probe is configured to be used as a push rod to advance the implantable device in the tissue during implantation of the implantable device, and the sensor probe includes a probe shoulder, the probe shoulder is configured to abut the inner cavity shoulder to allow force applied to the sensor probe to be transmitted to the implantable device.

[0013] This summary is an overview of some of the teachings of the present application and is not intended as an exclusive or exhaustive treatment of the subject matter. More details on the subject matter can be found in the detailed description and the appended claims. The scope of the present invention is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 is a perspective view of an implantable device and a syringe source for providing a flowable material to an adjustable membrane element of the implantable device according to an embodiment of the present subject matter.

[0015] Figure 2 According to the implementation of the present subject Figure 1 A longitudinal cross-sectional view of the implantable device is shown.

[0016] Figure 3 According to the embodiment of the present subject Figure 2 A cross-sectional view taken along line 3-3.

[0017] Figure 4 A guide probe is shown inserted into body tissue to an implantation site adjacent a body lumen of a patient prior to insertion of an implantable device in accordance with an embodiment of the present subject matter.

[0018] Figure 5 An implantable device according to an embodiment of the present subject matter is shown placed on a guide probe and partially advanced to a desired position, with an adjustable membrane element deflated.

[0019] Figure 6 An implanted device is shown after being expanded at a desired location in body tissue of a patient to move the body tissue toward a body lumen to cause an adjustable restriction of the body lumen in accordance with an embodiment of the present subject matter.

[0020] Figure 7 According to the embodiment of the present subject Figure 6 A cross-sectional view taken along line 7-7.

[0021] Figure 8 An implantable device according to an embodiment of the present subject matter is shown after insertion with its rear port beneath the patient's skin.

[0022] Fig. 9 is a schematic diagram of another implantable device according to an embodiment of the present subject matter.

[0023] Fig.10 is a schematic diagram of another implantable device according to an embodiment of the present subject matter.

[0024] Fig.11 is a top view showing a general target site for placement of an implantable device for improving urethral coaptation according to an embodiment of the present subject matter.

[0025] Fig.12 is a view along the length of the urethra in the region of implantation, showing the approximate target site for placement of an implantable device for improving coaptation of the urethra, according to an embodiment of the present subject matter.

[0026] Fig.13 is a diagram of an implantable device and a sensor probe according to an embodiment of the present subject matter.

[0027] Fig.14 is an illustration of a portion of a sensor probe according to an embodiment of the present subject matter.

[0028] Fig.15 is an illustration of a front end of a sensor probe according to an embodiment of the present subject matter.

[0029] Fig.16is a cross-sectional view of a portion of a leading end of an implantable device according to an embodiment of the present subject matter.

[0030] Fig.17 is a cross-sectional view of a portion of a leading end of an implantable device according to an embodiment of the present subject matter.

[0031] Fig.18 is an illustration of an implantable device having one or more sensors in accordance with an embodiment of the present subject matter.

[0032] Fig.19 is an illustration of an implantable device kit according to an embodiment of the present subject matter.

[0033] Fig. 20 is an illustration of engagement of a body lumen using an implantable device in accordance with an embodiment of the present subject matter.

[0034] Fig.21 is an illustration of engagement of a body lumen using two implantable devices in accordance with an embodiment of the present subject matter.

[0035] Fig. 22 is an image showing two implantable devices for engagement of a body lumen implanted in a patient adjacent to the body lumen, in accordance with an embodiment of the present subject matter.

[0036] Fig.23 is an illustration of a single lumen implantable device and a sensor probe in accordance with an embodiment of the present subject matter. DETAILED DESCRIPTION

[0037] The following detailed description of the subject matter refers to the subject matter in the accompanying drawings, which illustrate by way of illustration specific aspects and embodiments in which the subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the subject matter. References to "one," "an," or "various" embodiments in this disclosure do not necessarily refer to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is illustrative and should not be construed as limiting. The scope of the subject matter is defined by the appended claims and the full scope of legal equivalents to which such claims are entitled.

[0038] Among other things, the document discusses systems and methods for monitoring placement and / or adjustment of an implantable device for treating urinary incontinence. The implantable device may include an adjustable membrane element connected to a rear port, for example, by a catheter having an inner cavity that provides fluid communication between a chamber of the adjustable membrane element and a cavity of the rear port. The implantable devices discussed in this document (e.g., Figure 1 Various structural elements of the implantable device 110 shown may be referred to by various terms. An "adjustable membrane element" (e.g., Figure 1 The adjustable membrane element 112 shown may also be referred to as, for example, an adjustable element, an expandable element, an expandable membrane element, a forward expandable membrane element, a balloon, or an adjustable balloon. Figure 1 The catheter 114 shown may also be referred to as, for example, a central catheter element, a device catheter, a connecting catheter, a connecting guidewire, or a tubular elongated body. A "rear port" (e.g., Figure 1 The rear port 116 shown may also be referred to as, for example, a rear port portion or a rear port element. An "inner cavity" (e.g., Figure 2 The first inner cavity 215 and the second inner cavity 217 shown in FIG. 1 may also be referred to as, for example, a channel, an inner channel, or an internal channel.

[0039] In one example, the implantable device includes an adjustable balloon connected to a port with a catheter. The balloon is placed adjacent to the urethra to apply non-circumferential compression to the urethral wall. The effectiveness of physical therapy depends on the correct positioning of the balloon in the patient's body, such as the retropubic space near the urethrovesical anastomosis above the urogenital diaphragm near the urethral wall (generated by radical prostatectomy). When two balloons (e.g., two implantable devices) are used, their preferred positions are usually symmetrical and transverse to the urethra. Fluoroscopy or transrectal ultrasound can be used to visually monitor the position of the balloon during the implantation of the implantable device. Fluoroscopy has become a standard technique, but fluoroscopy exposes the patient to radiation and provides a two-dimensional view that is difficult to view in some cases. For example, when the patient is on the operating table, the fluoroscopic image does not show the position of the balloon in the anterior-posterior plane, and therefore does not show whether the balloon is correctly positioned to apply pressure to the urethral wall. Transrectal ultrasound (TRUS) can provide better observation (e.g., the position of the balloon in the anterior-posterior plane), but requires the surgeon to be familiar with this imaging technique. During the implantable process, the implantable device is initially placed in the patient with the balloon positioned in the target space. The balloon may be slightly inflated to allow encapsulation (by the patient's tissue) without removal from the target space. After encapsulation, the patient will undergo one or more adjustment procedures during which the balloon is adjusted to obtain and maintain urinary control without causing undesirable obstruction.

[0040] The present subject matter uses one or more sensors incorporated into an implantable device and / or a surgical tool 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 its disadvantages, 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 ultrasonic transducers on the implantable device and / or the surgical tool, allowing the use of ultrasonic imaging to monitor the placement and adjustment of the balloon during device implantation. The ultrasonic sensor on the implantable device can further allow post-operative adjustment of the balloon.

[0041] In various embodiments, the present subject matter provides sensing devices for monitoring, for example, the position of each balloon and the amount of inflation (expansion) of each balloon. In various embodiments, the sensing device can also be used to monitor various states of the urethra, which can indicate the amount of compression produced by the degree of balloon expansion, such as excessive compression produced by over-inflation of the balloon, sufficient compression (the goal of treatment), and insufficient compression produced by insufficient inflation of the balloon. The goal of treatment is to provide the patient with continence without unexpected obstruction, and this requires the correct amount of engagement of the urethra produced by placing the balloons in the correct position and giving each balloon the correct amount of inflation. The present subject matter allows the correct position and the correct amount of inflation to be determined for each balloon.

[0042] Figures 1 to 10 Various embodiments of implantable medical devices and surgical tools are shown. The surgical tool includes an elongated body and can be used as a base device onto which one or more sensors can be incorporated. The implantable medical device can be used with a surgical tool including a sensor, or can be used as a base device onto which one or more sensors can be incorporated. Various embodiments of implantable devices and surgical tools are shown in Figures 1 to 10 These and other examples of implantable devices and surgical tools are discussed in and below by way of example and not by way of limitation. These and other examples of implantable devices and surgical tools are discussed in U.S. Pat. No. 5,964,806, U.S. Pat. No. 6,045,498, U.S. Pat. No. 6,419,624, U.S. Pat. No. 6,579,224, and U.S. Pat. No. 8,926,494, all of which are assigned to UroMedica, Inc., and are incorporated herein by reference in their entirety. Figures 11 to 23 Various embodiments are shown that incorporate one or more sensors on implantable devices and / or surgical tools such as those discussed in the document.

[0043] One or more sensors 2328 are incorporated into the implantable device 2310 and one or more of the surgical tools 2324 for placement and / or adjustment of the implantable device. The implantable device includes an adjustable membrane element 2312 for controllable engagement of a body lumen, such as engagement 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.

[0044] According to Figure 1 The present subject matter shown provides an elongated implantable device 110 including an adjustable membrane element 112 shown in its fully expanded size and press-fittingly attached to an elongated catheter 114 connected to a first lumen 215 (see Figure 2 ) A rear port 116 in communication with the expandable element 112. The catheter 114 has a pointed front end 114A that slightly extends 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 through the rear port 116 to expand the adjustable membrane element 112.

[0045] like Figure 2 and 3 As further shown, the catheter 114 includes two elongated lumens or channels. The first lumen 215 provides an internal passage through which the flowable material is directed from the lumen 216A in the rear port 116 to expand the adjustable membrane element 112. The catheter 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 is used to receive an elongated guide probe (see Figure 4 ) and achieve delivery of the implantable device 110 to a desired location in the patient's body tissue.

[0046] Important features of the implantable device 110 having a first lumen 215 include a first opening port 215A, which is located in the cavity 216A of the rear port 116 between the elastic diaphragm 218 and the catheter 114 and is connected to the first lumen 215, so that the flowable material can be injected through the first opening port 215A, and the second port 215B is used to guide the working fluid to the adjustable membrane element 112. During the adjustment of the volume of the membrane fluid provided from the hollow needle 121 of the syringe 120, the membrane fluid is injected through the diaphragm 218 and continues through the catheter 114 connected to the adjustable membrane element 112. The rear port 116 preferably has a larger diameter than the catheter 114 to accommodate the cavity 216A and the diaphragm 218, and the diaphragm 218 is firmly held by the clamp ring 119.

[0047] The entire implantable device 110 including the adjustable membrane element 112 is formed of a biocompatible material such as silicone or polyurethane elastomer, and the catheter 114 and the rear port 116 can be formed as an integral structure. Alternatively, the adjustable membrane element 112, the rear port 116 and the catheter 114 can be molded as one piece. Figure 2 As shown, the adjustable membrane element 112 is adhered to the conduit 114 at its front end at 213 by a suitable adhesive material.

[0048] The implantable device and assembly according to the present subject matter may include three main components. The first component provided is a rigid solid elongated guide probe 424 (see Figure 4 ) in the form of an elongated guide member configured to deliver the implantable device 110 to a desired location in a patient's body tissue, such as by Figure 4 and Figure 5 As shown generally. Alternatively, the elongated guiding member can be in the form of a flexible guide wire, which has initially been delivered to the body tissue by a separate hollow rigid probe that has been inserted into the desired position in the body tissue. The second member of the assembly is an implantable device 110, which includes an adjustable membrane element 112, a catheter 114 comprising two lumens 215 and 217, and a rear port 116. During its implantation, after an elongated solid guiding probe 424 is first surgically inserted into the body tissue of the patient to establish an initial access, the implantable device 110 is guided to a predetermined position of a body lumen in the body of the adjacent patient. The lumen front end opening 117A of the implantable device 110 is then arranged above the rear end of the guiding probe 424 to guide the implantable device 110 and the adjustable membrane element 112 (in its contracted shape) is delivered to the predetermined position of the lumen that will be adjustably restricted in the adjacent body tissue. The diameter of the second lumen 217 is made slightly larger than the diameter of the guide probe 424 to allow the implantable device 110 to slide easily over the probe member.

[0049] During implantation of the implantable device 110, the physician may first make a small incision in the skin 430 of the patient near the body cavity 432 to be restricted, and then guide the solid guide probe 424 to the desired location according to the patient's anatomy by means of visualization such as fluoroscopy or ultrasound imaging. Thereafter, the opening 117A of the second lumen 117 of the catheter 114 is slid over the rear end 424A of the guide probe 424 with the adjustable membrane element 112 in its initial deflated or contracted state. The guide probe 424 slides through the second lumen 217 of the catheter 114 and exits at the rearward opening 117B. Figure 2As shown, 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 adjacent to the adjustable membrane element 112 or alternatively to extend the second lumen 217 through the rear port 116.

[0050] If desired, markings 533 may be provided on the guide stylet 424 which, when aligned with features on the implantable device 110, such as the rear port 116, may ensure that the implantable device 110 is properly placed at the correct depth in the patient's body tissue 430. It may be desirable to provide catheters 114 of various lengths to facilitate placement of the septum 218 adjacent to the patient's skin. Alternatively, the effective length of the catheter 114 may be made adjustable by having a helical shape similar to the helical shape of a coil spring.

[0051] After the implantable device 110 has been advanced over the guide probe 424 so that the retracted adjustable membrane element 112 is in the desired position adjacent the body lumen 432, the body lumen 432 can be restricted to the desired degree by piercing the septum 218 with the needle 121 of the syringe 120 and injecting the flowable material into the adjustable membrane element 112 through the first lumen 215. The physician can determine the desired degree of restriction of the body lumen 432 by, for example, injecting a fluid through the body lumen beyond the restriction and measuring the back pressure.

[0052] As Figure 1 and Figure 6 As shown, the source of the flowable material is typically a syringe 120 with a hollow needle for piercing the elastic diaphragm 218. However, alternative fluid containers with means for reversibly connecting to the implantable device 110 may be used. The flowable material may be, for example, a saline solution, 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 inflation can be viewed by X-ray.

[0053] An alternative method of delivering the implantable device 110 may be to first extract the guide probe 24 from the body tissue and then inflate the adjustable membrane element 112. Another alternative method may be to first place the implantable device 110 above the solid guide probe 424 outside the body and then insert both of them as a unit into the body tissue. To facilitate this latter procedure, some friction may be required between the solid guide probe 424 and the second lumen 217 in the catheter 114.

[0054] After the implantable device 110 has been properly positioned, with the adjustable membrane element 112 located near the body lumen 432 and the septum 218 in the rear port 116 located near the skin 430, the device is injected with a flowable material from the syringe 120. The expandable member can be inflated to a certain level and then deflated to a level suitable for encapsulating the expandable member through 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 above the port 116 by means such as sutures 834, such as Figure 8 shown.

[0055] The present subject matter provides adjustability of post-operative membrane expansion for the implantable device 110. This adjustability is achieved because the septum 218 is positioned distal to the adjustable membrane element 112 but adjacent to and beneath the patient's skin. The port and septum are located, for example, by manual palpation of the skin area, and the needle of a syringe 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.

[0056] To ensure proper sealing of the septum 218, the septum 218 is compressed and placed within the cavity 216A by providing a tight metal ring 119 surrounding the rear port 116 and having a smaller diameter than the port. When the needle 121 of the syringe 120 is withdrawn from the septum 218 after the adjustable membrane element 112 is expanded or adjusted, there is a positive seal around the periphery of the septum 218.

[0057] Figures 4 to 8 A method or procedure for appropriately implanting an implantable device 110 into a patient's body tissue is generally shown. Figure 4 As shown, after locating a body cavity such as the urethra of a patient, the physician makes a small incision 431 and inserts a guide probe 424 into the body tissue to a desired location adjacent to the body cavity 432. This procedure is typically performed by the physician under local anesthetic with visual guidance, such as under fluoroscopy. Next, the physician takes the implantable device 110 and passes it through the Figure 1 and Figure 2 The second lumen 217 is shown positioned above the guide probe 424. The guide probe 424 enters the rear opening 117B and exits the front opening 117A. In the case where the catheter 114 is sufficiently flexible, the implantable device 110 is advanced along the guide probe 424 into the body tissue.

[0058] 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, such as by Figure 6Next, the guide probe 424 is removed and the adjustable membrane element 112 is further expanded to the desired enlarged size for restriction of the body cavity 432. The syringe 120 is removed from the implantable device 110, after which the adjustable membrane element 112 of the desired size is maintained by the elastic diaphragm 218. Next, the patient's incision at 431 is surgically closed over the port 116 and the diaphragm 218 by sutures at 834.

[0059] Fig. 9 940 is an illustration of an implantable device kit 940 according to one embodiment of the present subject matter, showing a cross-sectional view. The implantable device kit 940 includes an implantable device 910 having an adjustable membrane element 912 and an elongated catheter 914, wherein the catheter 914 includes at least a first lumen 915 extending longitudinally from a first opening 915A at a rear end (also referred to as a proximal end) 962 to a second opening 915B in the catheter 914, and wherein the implantable device 910 is shown positioned within a channel 944 of a sheath 946.

[0060] The implantable device kit 940 also includes a rear port 916, wherein the rear port 916 is coupled to the rear end 962 of the catheter 914. In one embodiment, the rear port 916 is coupled to the rear end 962 of the elongated body 914 using a chemical adhesive, or alternatively using sonic welding techniques as known in the art. In other embodiments, the rear port 916 and the rear end 962 are formed together in a polymer molding process, such as liquid injection molding as known in the art.

[0061] The rear port 916 includes a cavity 916A, wherein the cavity 916A is in fluid communication with the first opening 915A of the catheter 914. In one embodiment, the rear port 916 also includes an elastic diaphragm 918, through which the cavity 916A is entered, wherein the elastic diaphragm 918 is sealable after repeated punctures, such as with a needle. In one embodiment, the elastic diaphragm 918 is retained in the rear port 916 by a clamp ring 919 located around the rear port 916. In one embodiment, the clamp ring 919 is made of a biocompatible material such as, for example, titanium. In one embodiment, the elastic diaphragm 918 is made 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 mm, wherein 4.5 mm is a specific example.

[0062] In one embodiment, the outer surface of the rear port 916 and the adjustable membrane element 912 have a size (e.g., diameter) that is smaller than the inner size (e.g., diameter) of the channel 944 to allow the implantable device 910 to move longitudinally through the channel 944 of the sheath 946. 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 its relaxed state to be compressed to a size that is small enough so that the implantable device 910 can move longitudinally through the channel 944 of the sheath 946. In various embodiments, the catheter 914 has sufficient rigidity to allow the force applied at the rear end of its tubular elongated body to move the implantable device 910 at least partially through the channel 944 of the sheath 946. In one embodiment, the rigidity of the catheter 914 is determined based on the type of material used to construct its tubular elongated body. Alternatively, a support element can be added to the tubular elongated body. For example, a metal coil can be placed longitudinally within the tubular elongated body to increase the rigidity of the tubular elongated body.

[0063] 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 coreless needle, wherein the needle is inserted through the elastic diaphragm 918. A measured fluid volume supply can be introduced into the implantable device 910, and the adjustable membrane element 912 expands or contracts due to the volume of the flowable material introduced into the cavity 916A of the rear port 916 from the source of flowable material. The adjustable membrane element 912 is then used to at least partially and adjustably restrict the body cavity. Fluids suitable for injection into the prosthesis include, but are not limited to, sterile saline solutions; polymer gels, such as silicone gels or hydrogels such as polyvinyl pyrrolidone, polyethylene glycol, carboxymethyl cellulose; high viscosity liquids, such as hyaluronic acid, dextran, polyacrylic acid, polyvinyl alcohol, or, for example, radiopaque fluids. Once the adjustable membrane element 912 has been inflated, the needle is withdrawn from the diaphragm of the rear port 916. In other embodiments, a detectable marker 970 is embedded in the continuous wall of the adjustable membrane element 912. The detectable marker 970 allows the adjustable membrane element 912 to be positioned within the patient's tissue using any number of visualization techniques that employ electromagnetic energy as a means of positioning an object within the body. In one embodiment, the detectable marker 970 comprises tantalum and the visualization technique used to visualize the adjustable membrane element 912 is an X-ray or fluoroscopy examination as known in the art.

[0064] In other embodiments, detectable markers are embedded in the implantable device 910. For example, detectable markers 970 are located at the front end (also referred to as distal end) 960 (e.g., tip) of catheter 914. Alternatively, detectable markers can be located in the continuous wall of adjustable membrane element 912. Detectable markers 970 allow the front end 960 or adjustable membrane element 912 to use any number of visualization techniques employing electromagnetic energy as the means of locating an object in vivo. In one embodiment, detectable markers 970 include tantalum and the visualization techniques for making the front end 960 or adjustable membrane element 912 visualized are X-rays or fluoroscopic fluoroscopy as known in the art. In other embodiments, sheaths can also have detectable markers, wherein markers can be incorporated in or on sheath walls. Alternatively, the whole sheath can be constructed to be radiopaque.

[0065] Fig.10 is an illustration of an additional embodiment of an implantable device 1010 according to the present subject matter. The implantable device 1010 includes an adjustable membrane element 1012 and a catheter 1014. The catheter 1014 has a leading end 1060. In one embodiment, the outer peripheral surface of the catheter 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 defining a chamber.

[0066] The catheter 1014 includes a first lumen 1015 and a second lumen 1017. In one embodiment, the first lumen 1015 extends longitudinally in the catheter 1014 from a first opening 1015A to one or more second openings 1015B (e.g., Fig.10 The second opening 1015B is in fluid communication with the chamber of the adjustable membrane element 1012 to adjustably expand or contract the adjustable membrane element 1012 by the flowable material introduced through the first opening 1015A.

[0067] Second lumen 1017 extends longitudinally along catheter 1014 from inlet 1017B to closed end 1017A at leading end 1060. In one embodiment, second lumen 1017 and inlet 1017B each have a sufficient diameter to receive a push rod that can be used to advance implantable device 1010 in tissue.

[0068] The implantable device 1010 also includes a rear port 1016 coupled to the rear end of the catheter 1014. In one embodiment, the rear port 1016 is similar to the rear port 916 and includes a cavity 1016A and an elastic diaphragm 1018. The cavity 1016A is coupled to the first inner cavity 1015 at the first opening 1015A and is in fluid communication with the first inner cavity 1015. The elastic diaphragm 1018 allows the use of a needle to transition to the cavity 1016A for introducing and / or withdrawing fluid to expand and / or withdraw the adjustable membrane element 1012.

[0069] Fig.11 1 is a top view of a bladder 1101 and a urethra 1102, showing an approximate target location for placement of an implantable device 1110 to improve urethral coaptation according to an embodiment of the present subject matter. Implantable device 1110 can present any embodiment of an implantable device as discussed in this document (where an expandable membrane element or an adjustable membrane element is shown in the figure to illustrate its location), 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. A Cartesian coordinate system having an X-axis, a Y-axis, and a Z-axis is in Figures 11 to 21 1002 (where two of the X, Y, and Z axes are seen in each of these figures) as a reference to exemplary orientations of the structures shown in these figures. The Z axis is oriented along the urethra 1002 in the direction of the approximate location of implantation. In the case of a radical prostatectomy, this location is near the bladder neck and urethrovesical anastomosis, or further down the urethra at the top of the prostate following a transurethral resection of the prostate (TURP).

[0070] Fig.12 1 is a view along the length of the urethra 1102 in the implantation region (or along the y-axis), showing the approximate target location for placement of the implantable device 1110 to improve coaptation of the urethra, according to one embodiment of the present subject matter. The present subject matter can assist in the proper placement of the implantable device 1110 during implantation in a patient and / or in the adjustment of the implantable device 1110 after implantation. In particular, the application of the present subject matter facilitates accurate placement of the implantable device 1110 along the Y-axis (sagittal view).

[0071] Fig.1313 is an illustration 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 can be provided as a device kit, which can also include other accessories. The implantable device 1310 can be used to engage an inner cavity in the body, and can include an adjustable membrane element 1312, an elongated catheter 1314, and a rear port 1316. The adjustable membrane element 1312 is configured to engage the inner cavity and includes a continuous wall having an inner surface defining a chamber. The catheter 1314 has a rear end 1315, a front end 1313 coupled to the adjustable membrane element 1312, a peripheral surface connected to and sealed to the adjustable membrane element 1312 near the front end 1313, and an inner cavity ( Fig.13 1314). The rear port 1316 is coupled to the rear end 1315 and includes a chamber in fluid communication with the first opening of the first lumen and an elastic diaphragm that allows access to the cavity by a needle. In some embodiments, the rear port 1316 is releasably coupled to the rear end of the catheter 1314. The implantable device 1310 can present any embodiment of an implantable device as discussed in this document, including but not limited to the implantable device 110, the implantable device 910, the implantable device 1010, or an implantable device including various combinations of features of the implantable devices 110, 910, and 1010.

[0072] Sensor probe 1324 has an elongated body 1326 including a rear end 1327 and a front end 1325, and one or more sensors 1328 incorporated into elongated body 1326. In various embodiments, sensor probe 1324 can be incorporated into any surgical tool having an elongated body that is used during implantation and / or adjustment of implantable device 1310. Examples of such surgical tools include a push rod (e.g., push rod 1450) and a guide probe (or guide rod or guide wire, such as guide probe 424). In one embodiment, as Fig.13 As shown, a sensor 1328 is shown at the front end 1325. In another embodiment, as Fig.14 , which illustrates a portion of a sensor probe 1424 having a plurality of sensors 1328 distributed over at least a portion of an elongated body 1326, in accordance with an embodiment of the present subject matter.

[0073] In various embodiments, the sensor 1328 can be rotated by rotating the elongated body 1326, for example, by rotating the rear end 1327. The elongated body 1326 can include a sensor connection circuit 1330, for example, 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 the signal sensed by the sensor 1328. In another embodiment, the sensor connection circuit 1330 includes a telemetry circuit and a battery so that it can communicate with the external system in a wireless manner. The telemetry circuit can perform wireless communication using, for example, electromagnetic, magnetic, acoustic, or optical telemetry.

[0074] In various embodiments, the sensor 1328 may include one or more ultrasonic transducers, each of which converts an electrical input signal into ultrasound, transmits the ultrasound, receives reflected ultrasound (echoes of the transmitted ultrasound), and converts the received reflected ultrasound into an electrical image signal. An external system may receive the electrical image signal and generate an ultrasonic image based on the electrical image signal. The one or more ultrasonic transducers may each include a piezoelectric transducer or a capacitive transducer, and each have an ultrasonic beam direction and an ultrasonic beam angle.

[0075] In various embodiments, sensor 1328 may include one or more optical sensors. The one or more optical sensors may each 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 the captured image into an electrical image signal. An external system may receive the electrical image signal and generate a visual image based on the electrical image signal.

[0076] In various embodiments, the lumen of the implantable device 1310 in fluid communication with the chamber is also configured to receive a push rod (e.g., Fig. 9 13. The end of the lumen at the front end 1313 is configured to receive a force applied by 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 hardness to receive the front end 1325 of the sensor probe 1324 and transmit the force applied at the rear end 1327 of the sensor probe to the implantable device 1310.

[0077] 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 catheter 1314 and configured to receive a sensor probe 1324 (e.g., such as Figure 2 , Figure 3 , Figure 5 and Fig.10 13). The second lumen includes an inlet at or near the rear end 1315 of the catheter 1314 and an outlet at or near the front end 1313 of the catheter 1314. The front end 1313 is configured to receive a force applied by the sensor probe 1324 to move the implantable device 1310.

[0078] In one embodiment, the second lumen includes a closed end near the front end 1313 of the catheter 1314. The closed end has sufficient strength and rigidity to receive the front end 1325 of the sensor probe 1324 and transmit forces applied at the rear end 1327 of the sensor probe 1324 to the implantable device 1310. Fig.16 1 is a cross-sectional view of a portion of a front end 1613 of an elongated catheter 1614 according to an embodiment of the present subject matter, showing a closed end of a first internal channel or a second internal channel, which is configured to receive a force applied by a sensor probe 1324 to move an implantable device 1310. The front end 1613 can represent an example of a front end 1313. In one embodiment, the front end 1613 includes a sensor window 1635 to provide transparency to the signal to be sensed. For example, an ultrasonic transparent material can be used for the sensor window 1635. The sensor window 1635 can be configured for a specified overall ultrasound beam angle, up to 360 degrees (i.e., the sensor window has a length equal to the circumference of the second lumen).

[0079] In another embodiment, the sensor probe 1324 includes a sharp tip suitable for penetrating tissue, such as Fig.10 In the example shown. Fig.15 1 is a diagram showing a leading end 1525 of a sensor probe 1524 according to an embodiment of the present subject matter. The sensor probe 1524 can represent an example of the sensor probe 1324 and includes a sharp tip 1531 at the leading end 1525. The second lumen includes an exit port near the leading end 1313 of the catheter 1314. The exit port allows a portion of the sensor probe 1524 including the sharp tip 1531 to protrude from the catheter 1314. Fig.17 17 is a cross-sectional view of a portion of a front end 1713 of an elongated catheter 1714 according to an embodiment of the present subject matter. The front end 1713 can represent an example of the front end 1313. The second lumen includes a first shoulder 1736 and the sensor probe 1524 includes a second shoulder 1532 that is configured to abut the first shoulder 1736 to allow a force applied at the rear end 1327 of the sensor probe 1324 to be transmitted to the implantable device 1310. In one embodiment, as Fig.15 and Fig.17As shown, the first shoulder 1736 is formed by a change in the diameter of the second lumen, and the second shoulder 1532 is formed by a change in the diameter of the sensor probe 1524. The sensor 1328 can be incorporated into the elongated body 1526 of the sensor probe 1524 at the front end 1525 so that both the sharp tip 1531 and the sensor 1328 can protrude from the catheter 1314 of the implantable device 1310.

[0080] Fig.18 1 is an illustration of an implantable device 1810 having one or more sensors according to an embodiment of the present subject matter. The implantable device 1810 includes the implantable device 1310 as discussed above and one or more sensors 1828 incorporated into the implantable device 1310. The implantable device 1810 also includes a sensor connection circuit 1840, for example, at the rear end 1315, and a conductor 1841 extending within the elongated body 1314 to provide a connection between the sensor 1828 and the sensor connection circuit 1840. In the illustrated embodiment, the implantable device 1810 includes six sensors 1828 at the distal connection between the adjustable membrane element 1312 and the catheter 1314, at the rear connection between the adjustable membrane element 1312 and the catheter 1314, and along the midline of the adjustable membrane element 1312 perpendicular to the catheter (i.e., perpendicular to the Z axis). In various embodiments, any number of sensors are incorporated into any location on the implantable device 1810. For example, one or more sensors 1828 can be incorporated into the catheter 1314 (e.g., at or adjacent to the front end 1313, at or adjacent to the distal connection between the adjustable membrane element 1312 and the catheter 1314, and / or at or adjacent to the rear connection between the adjustable membrane element 1312 and the catheter 1314) and / or the adjustable membrane element 1312 (e.g., on the midline of the adjustable membrane element 1312 perpendicular to the catheter 1314, adjacent to the distal connection between the adjustable membrane element 1312 and the catheter 1314, and / or adjacent to the rear connection between the adjustable membrane element 1312 and the catheter 1314).

[0081] In various embodiments, the sensor 1828 may include one or more ultrasonic transducers, each of which converts an electrical input signal into ultrasound, transmits the ultrasound, receives reflected ultrasound (echoes of the transmitted ultrasound), and converts the received reflected ultrasound into an electrical image signal. An external system may receive the electrical image signal and generate an ultrasonic image based on the electrical image signal. One or more ultrasonic transducers may each include a piezoelectric transducer or a capacitive transducer, and each have an ultrasonic beam direction and an ultrasonic beam angle. Multiple ultrasonic transducers may be arranged on the implantable device 1810 to provide a specified overall ultrasonic beam angle (e.g., 90, 180, 270, or 360 degrees).

[0082] In various embodiments, the sensor 1828 may include one or more optical sensors. The one or more optical sensors may each include a CCD image sensor or an APS to convert the captured image into an electrical image signal. An external system may receive the electrical image signal and generate a visual image based on the electrical image signal.

[0083] In various embodiments, sensor 1828 may include one or more of any type that can sense signals that help assist in the placement and adjustment of implantable device 1810, such as pressure sensors and strain gauges.

[0084] The sensor connection circuit 1840 can be within the rear port 1316 and provide 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 to pierce the elastic septum of the rear port 1316 and mate with the connector in the rear port 1316. In another embodiment, the implantable device 1810 can communicate with the external system wirelessly. The sensor connection circuit 1840 includes a telemetry circuit and a battery or an inductive power receiver. The telemetry circuit can transmit power to the implantable device 1810 and receive sensed signals from the implantable device 1810.

[0085] Fig.19 1 is a diagram of an implantable device kit 1920 according to an embodiment of the present subject matter. The implantable device kit includes at least an implantable device 1810 and a sensor probe 1324, such as Fig.19 1828 and sensor probe 1324. The implantable device 1810 may be provided with a plurality of sensors, such as those shown in FIG. ...

[0086] Fig. 202024 and 1524. Sensor 2028 represents any one or more sensors incorporated into implantable device 2010 and probe 2024. In one embodiment, sensor 2028 provides a sensor such as a sensor or a sensor. Fig. 22 The images shown are used to guide placement of implantable device 2010 adjacent lumen 1102 (eg, urethra) to achieve engagement of the lumen, and / or to allow a determination of whether the body lumen has been engaged to a desired degree.

[0087] Fig.21 is an illustration of engagement of a body lumen 1102 using two implantable devices 2010 and two stylets 2024 in accordance with an embodiment of the present subject matter. Fig. 22 An example of an image of the therapy is shown. When the body lumen (e.g., urethra) is properly engaged, the adjustable membrane element 1312 facing the lumen of each implantable device is observed to flatten. In various embodiments, the sensor 2028 can be used to provide images and / or other information indicating the position of each of the implantable devices 2010, the degree of flattening of the adjustable membrane element 1312, and / or the shape of the body lumen, thereby providing guidance when placing and / or adjusting the implantable device 2010. The shape of the body lumen can indicate the degree of engagement of the body lumen. In various embodiments, the sensor 2028 placed in each of the implantable devices 2010 can detect information indicative of the shape of the adjustable membrane element 1312 of the same implantable device, the position of the adjustable membrane element 1312 of the same implantable device (e.g., relative to the body lumen 1102), the shape of the adjustable membrane element 1312 of another implantable device 2010, the position of the adjustable membrane element 1312 of another implantable device 2010 (e.g., relative to the body lumen 1102), and / or the shape of the body lumen 1102. In various embodiments, the sensor 2028 placed in the implantable device 2010 can detect information indicative of the shape and / or position of another implantable device or a portion thereof that is present in tissue near the implantable device 2010.

[0088] Fig.2323 is an illustration 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 an example of the implantable device kit 1320, wherein the implantable device 2310 is used for engagement of the urethra, and the sensor probe 2324 is used to detect one or more indications of the engagement state or degree of the urethra and adjust the volume in the adjustable membrane element 2312 of the implantable device 2310 to obtain optimal efficacy in treating urinary incontinence without causing obstruction of the urethra. 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 fixed 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 catheter 2314 and is in fluid communication with the chamber of the adjustable membrane element 2312 at the distal opening 2315B and is in fluid communication with the lumen 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 serve 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 in tissue by applying force to the closed front end of the lumen 2315 at the front end 2360, and (3) a hollow needle including a lumen 2365 through which fluid can be introduced and withdrawn to inflate and deflate the adjustable membrane element 2312, respectively, through the distal opening 2315B of the lumen 2315. The inner cavity 2315 is configured to accommodate the front portion of the sensor probe 2324, wherein the front end of the sensor probe 2324 reaches the closed front end of the inner cavity 2315. Fig.23 As shown, when the adjustable membrane element 2312 is placed adjacent to the urethra and deflated, pressure from the urethra can flatten one side of the adjustable membrane element 2312. The sensor 2328 can allow this flattening to be observed, which indicates the amount of pressure that can be adjusted for optical efficacy in treating urinary incontinence.

[0089] like Fig.23As shown, adjustable membrane element 2312 is inflated to provide urethral engagement and has a flattened portion where it encounters expansion resistance from the urethra. Implantable device 2310 includes a radiopaque marker 2370 at the front end 2360. Radiopaque marker 2370 is also used as a stopper for sensing probe 2324 to ensure that it is in the correct position for sensing. The stopper is also used as a stopper for a push rod (e.g., a sensor probe 2324 used as a push rod) for placement of implantable device 2310 in an initial implantation procedure. When sensor probe 2324 is used as a push rod, sensor 2328 can be used to guide the placement and / or initial adjustment of implantable device 2310 to observe the engagement of the urethra. Rear port 2316 includes a self-sealing septum 2318 to allow sensor probe 2324 (and other push rods or push wires, if used) to enter lumen 2315. The front end of sensor probe 2324 has a sharp tip for piercing septum 2318. Advantages of a single lumen implantable device include providing a larger cross-sectional area to accommodate the sensor 2328 within a catheter 2314 of a given diameter.

[0090] In the illustrated embodiment, the sensor 2328 is an optical sensor for visually observing the flattening of the adjustable membrane element 2312 against the urethra as an indicator of actual visualization of the engagement within the urethra. In another embodiment, the sensor 2328 is an ultrasonic sensor. In addition to directly observing the engagement of the urethra, if the ultrasonic sensor transmits ultrasound with sufficient penetration depth within the tissue, it can also allow visualization of the adjustable membrane element 2312 relative to anatomical structures such as the bladder neck and rectum. This visualization can be used to assist 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 and / or visualization of the adjustable membrane element 2312 in the tissue relative to various anatomical structures.

[0091] In the illustrated embodiment, the sensor 2328 (i.e., an 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 by means of a mirror 2363. The chip 2362 is powered and returns data acquired by the sensor 2328 via an electric heating wire 2364. The electric heating wire 2364 can also be used to power a light source such as an LED to help with visualization (if the chip 2362 is an infrared CCD or CMOS chip, it is not necessary). The sensor probe 2324 can be rotated around its longitudinal axis within the inner cavity 2315 to scan circumferentially to find the maximum engagement point of the flattening of the adjustable membrane element 2312. Rotating the sensor probe 2324 can also help it pass through the bend in the catheter 2314, especially when the rear port 2316 is directed to the scrotum or labia. At least for this reason, the sensor probe 2324 is provided with a certain amount of flexibility. In one embodiment, the sensor probe 2324 having the optical sensor 2328 is equipped with a wide angle lens to allow viewing of the entire inner surface of the adjustable membrane element 2312, so that circumferential scanning is not required.

[0092] In another embodiment, the sensor probe 2324 can include a borescope for optical visualization, wherein a fiber optic bundle extends through the sensor probe. A light source within the sensor probe 2324 is unnecessary, as the optical fiber can also be used to transmit light from a light source externally connected to the sensor probe. The fiber optic bundle can have a significantly smaller diameter when compared to the size of the CCD or CMOS chip, thereby reducing the diameter of the sensor probe 2324, and thus reducing the diameter of the catheter 2314 and the rear port 2316. This allows the overall size of the implantable device 2310 and the overall size of the sensor probe 2328 to be reduced. The smaller diameter of the sensor probe 2324 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 after the implantable device is implanted in the patient. In addition, the fiber optic implementation of the sensor probe 2324 can reduce production costs when compared to an optical sensor implementation with a CCD or CMOS chip, thereby improving the affordability of making the sensor probe 2324 into a disposable device.

[0093] This application is intended to cover adaptations or variations of this subject matter. It should be understood that the above description is intended to be illustrative rather than restrictive. The scope of this subject matter should be determined by reference to the appended claims and the full scope of legal equivalents to which these claims are entitled.

[0094] According to the above description, the embodiments of the present invention also disclose the following technical solutions, including but not limited to:

[0095] Solution 1. An implantable device kit for controlled engagement of a body cavity in a living tissue, comprising:

[0096] An implantable device configured to control engagement of the body lumen, the implantable device comprising:

[0097] an adjustable membrane element comprising a continuous wall having an inner surface defining a chamber;

[0098] an elongated conduit comprising a conduit peripheral surface connected to and sealed to the adjustable membrane element at or near the conduit forward end, a conduit rear end, a conduit forward end, and a conduit lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit forward end; and

[0099] a rear port connected to a rear end of the catheter, the rear port comprising a lumen in fluid communication with the first opening of the catheter lumen; and

[0100] A sensor probe, comprising a probe front end, the probe front end being configured to enter the catheter lumen by piercing the septum and reach the closed end of the catheter lumen, the sensor probe comprising a sensor, the sensor being configured to detect information indicating at least one of the shape of the adjustable membrane element, the position of the adjustable membrane element, or the shape of the body lumen.

[0101] Option 2. The implantable device kit according to Option 1 further includes an additional implantable device, wherein the additional implantable device includes an additional adjustable membrane element, and wherein the sensor probe is configured to further detect information indicating at least one of the shape of the additional adjustable membrane element or the position of the additional adjustable membrane element.

[0102] Option 3. An implantable device kit according to any of the preceding options, wherein the sensor probe includes a probe lumen, which is configured to be connected to the chamber fluid of the adjustable membrane element when the front end of the probe is within the catheter lumen at the closed end of the catheter lumen, so as to allow inflation of the adjustable membrane element by introducing fluid into the chamber via the probe lumen, and to allow deflation of the adjustable membrane element by extracting the fluid from the chamber via the probe lumen.

[0103] Option 4. An implantable device kit according to any of the preceding options, wherein the sensor probe is configured to be used as a push rod to advance the implantable device in the tissue during implantation of the implantable device.

[0104] Embodiment 5. The implantable device kit according to any one of the preceding embodiments, wherein the sensor comprises an optical sensor configured to sense information indicative of the shape of the adjustable membrane element.

[0105] Embodiment 6. The implantable device kit of embodiment 5, wherein the optical sensor comprises an imaging device configured to provide visualization of the inner surface of the continuous wall of the adjustable membrane element.

[0106] Embodiment 7. The implantable device kit of Embodiment 5, wherein the optical sensor comprises a fiber optic borescope configured to provide visualization of the inner surface of the continuous wall of the adjustable membrane element.

[0107] Option 8. An implantable device kit according to any one of Options 1 to 4, wherein the sensor includes an ultrasonic sensor, and the ultrasonic sensor is configured to provide an ultrasonic image, which shows the shape of the body cavity and the position of the adjustable membrane element relative to the body cavity, wherein the shape of the body cavity indicates the degree of engagement of the body cavity.

[0108] Solution 9. An implantable device kit for controlled engagement of a body cavity in a living tissue, comprising:

[0109] a sensor probe comprising a probe front end and a sensor incorporated into the probe front end; and

[0110] An implantable device configured to control engagement of the body lumen, the implantable device comprising:

[0111] an adjustable element comprising a continuous wall having an interior surface defining a chamber;

[0112] An elongated catheter comprising a catheter peripheral surface, a catheter rear end, a catheter front end, a first catheter lumen, and a second catheter lumen, wherein the catheter peripheral surface is connected to and sealed to the adjustable element at or near the catheter front end, the first catheter lumen having a first opening at the catheter rear end and a second opening in fluid communication with the chamber, the second catheter 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 catheter front end, and the second catheter lumen is configured to allow the probe front end to be advanced to the closed end; and

[0113] a rear port connected to a rear end of the catheter, the rear port comprising a lumen in fluid communication with the first opening of the first catheter,

[0114] Wherein 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, or a shape of the body cavity.

[0115] Option 10. The implantable device kit according to Option 9 further includes an additional implantable device, wherein the additional implantable device includes an additional adjustable membrane element, and wherein the sensor probe is configured to further detect information indicating at least one of a shape of the additional adjustable membrane element or a position of the additional adjustable membrane element.

[0116] Option 11. The implantable device kit according to any one of Options 9 and 10 further includes a push rod configured to advance the implantable device in the tissue during implantation of the implantable device, and wherein the entrance of the second catheter lumen is configured to receive a portion of the push rod, and the second catheter lumen is configured to accommodate a portion of the push rod.

[0117] Option 12. An implantable device kit according to any one of Option 9 and Option 10, wherein the sensor probe is configured to be used as a push rod to advance the implantable device in the tissue during implantation of the implantable device.

[0118] Embodiment 13. The implantable device kit according to any one of embodiments 9 to 12, wherein the sensor comprises an optical sensor configured to sense information indicative of the shape of the adjustable membrane element.

[0119] Embodiment 14. The implantable device kit of embodiment 13, wherein the optical sensor comprises an imaging device configured to provide visualization of the inner surface of the continuous wall of the adjustable membrane element.

[0120] Embodiment 15. The implantable device kit of embodiment 13, wherein the optical sensor comprises a fiber optic borescope configured to provide visualization of the inner surface of the continuous wall of the adjustable membrane element.

[0121] Option 16. An implantable device kit according to any one of Options 9 to 12, wherein the sensor includes an ultrasonic sensor, which is configured to provide an ultrasonic image, which shows at least one of the shape of the body cavity and the position of the adjustable membrane element relative to the body cavity, wherein the shape of the body cavity indicates the degree of engagement of the body cavity.

[0122] Embodiment 17. An implantable device configured to be implanted in body tissue adjacent to a body cavity for controllable engagement of the body cavity, the implantable device comprising:

[0123] an adjustable membrane element comprising a continuous wall having an inner surface defining a chamber;

[0124] An elongated catheter comprising:

[0125] connected to and sealed to the peripheral surface of the conduit of the adjustable membrane element;

[0126] The rear end of the catheter;

[0127] The front end of the catheter; and

[0128] a catheter lumen extending longitudinally in the catheter from a first opening at a rearward end to a second opening in fluid communication with a chamber of the implantable device to adjustably expand or contract the adjustable membrane element by flowable material introduced through the first opening; and

[0129] One or more sensors incorporated into at least one of the adjustable membrane element or the elongated catheter and configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body lumen.

[0130] Embodiment 18. An implantable device according to Embodiment 17, wherein the one or more sensors include at least one ultrasonic sensor.

[0131] Option 19. The implantable device according to any one of Option 17 and Option 18, further comprising an additional catheter extending longitudinally in the catheter, the additional catheter lumen having an inlet configured to receive a portion of the push rod.

[0132] Option 20. An implantable device according to any one of Options 17 to 19, further comprising a rear port connected to the elongated catheter at the rear end of the catheter, the rear port comprising a cavity and an elastic diaphragm configured to seal the cavity, the cavity being configured to contain the flowable material and being connected to the catheter lumen fluid.

Claims

1. An implantable device kit for controlled engagement of a body cavity in a living tissue, comprising: Two implantable devices, each implantable device comprising: an adjustable membrane element comprising a continuous wall having an interior surface defining a chamber, the adjustable membrane element being configured to engage the body lumen; an elongated conduit comprising a conduit peripheral surface connected to and sealed to the adjustable membrane element at or near the conduit forward end, a conduit rear end, a conduit forward end, and a conduit lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit forward end; and a rear port connected to the rear end of the catheter and including a lumen in fluid communication with the first opening of the catheter lumen; and two sensor probes, each sensor probe being configured to be partially placed in one of the two implantable devices, and each sensor probe comprising: a probe front end having a sharp tip and configured to enter the catheter lumen of the one implantable device by piercing the rear port of the one implantable device and reach the closed end of the catheter lumen; and 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, or a shape of the body lumen, Wherein, each of the two implantable devices is configured to be implanted in the tissue, wherein the adjustable membrane element is adjacent to the body cavity.

2. The implantable device kit of claim 1, wherein: The two sensor probes each include a probe lumen, which is configured to be connected to the chamber fluid of the adjustable membrane element of the one implantable device when the front end of the probe is within the catheter lumen of the one implantable device at the closed end of the catheter lumen, so as to allow inflation of the adjustable membrane element by introducing fluid into the chamber via the probe lumen, and to allow deflation of the adjustable membrane element by withdrawing the fluid from the chamber via the probe lumen.

3. The implantable device kit according to any one of claims 1 and 2, wherein: The two sensor probes are each configured to function as a push rod to advance the one implantable device in the tissue during implantation of the one implantable device.

4. The implantable device kit according to any one of claims 1 to 3, wherein: The sensor comprises an optical sensor.

5. The implantable device kit according to any one of claims 1 to 3, wherein: The sensor includes an ultrasonic sensor.

6. The implantable device kit according to any one of claims 1 to 5, wherein: The catheter front end includes a sensor window that provides transparency to signals to be received by the sensor when the sensor is placed within the catheter lumen.

7. The implantable device kit according to any one of claims 1 to 6, wherein: The sensor is configured to detect information indicative of a shape of the body lumen, the shape indicative of a degree of occlusion of the body lumen.

8. An implantable device kit for controlled engagement of a body lumen in tissue of a living subject, comprising: two sensor probes, each sensor probe comprising a probe front end and a sensor incorporated on the probe front end, the sensor configured to detect information indicative of a degree of engagement of the body lumen; as well as Two implantable devices, each implantable device comprising: an adjustable membrane element comprising a continuous wall having an interior surface defining a chamber, the adjustable membrane element being configured to engage the body lumen; An elongated catheter comprising a catheter peripheral surface, a catheter rear end, a catheter front end, a first catheter lumen, and a second catheter lumen, wherein the catheter peripheral surface is connected to and sealed to the adjustable membrane element at or near the catheter front end, the first catheter lumen having a first opening at the catheter rear end and a second opening in fluid communication with the chamber, the second catheter 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 catheter front end, and the second catheter lumen is configured to allow the probe front end to be advanced to the closed end; and a rear port connected to a rear end of the catheter and comprising a lumen in fluid communication with the first opening of the first catheter, Wherein, each of the two implantable devices is configured to be implanted in the tissue, wherein the adjustable membrane element is adjacent to the body cavity.

9. The implantable device kit of claim 8, wherein: The two sensor probes are each configured to function as a push rod to advance an implantable device in the tissue during implantation of the implantable device.

10. The implantable device kit according to any one of claims 8 and 9, wherein: The sensor comprises an optical sensor.

11. The implantable device kit of claim 10, wherein: The optical sensor includes a camera device.

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

13. The implantable device kit according to any one of claims 8 and 9, wherein: The sensor includes an ultrasonic sensor.

14. The implantable device kit according to any one of claims 8 to 13, wherein: The catheter front end includes a sensor window that provides transparency to signals to be received by the sensor when the sensor is placed in the second catheter lumen.

15. The implantable device kit according to any one of claims 8 to 13, wherein: The second catheter lumen includes an exit port at or near the catheter leading end, the exit port allowing the probe leading end including the sensor to protrude from the elongated catheter.

16. An implantable device configured to be implanted in body tissue adjacent a body lumen for controllable engagement of the body lumen, the implantable device comprising: an adjustable membrane element comprising a continuous wall having an inner surface defining a chamber; An elongated catheter, the elongated catheter comprising: connected to and sealed to the peripheral surface of the conduit of the adjustable membrane element; The rear end of the catheter; The front end of the catheter; and a catheter lumen extending longitudinally in the catheter from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device to adjustably expand or contract the adjustable membrane element by flowable material introduced through the first opening; and One or more sensors incorporated into at least one of the adjustable membrane element or the elongated catheter and configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body lumen.

17. The implantable device of claim 16, wherein: The one or more sensors include at least one ultrasonic sensor.

18. The implantable device of claim 16, wherein: The one or more sensors include at least one optical sensor.

19. The implantable device of claim 16, wherein: The one or more sensors include at least one pressure sensor.

20. The implantable device of claim 16, wherein: The one or more sensors include at least one strain gauge.

21. The implantable device of any one of claims 16 to 20, further comprising an additional catheter lumen extending longitudinally in the catheter, the additional catheter lumen having an inlet configured to receive a portion of the push rod.

22. The implantable device according to any one of claims 16 to 20 further includes a rear port connected to the slender catheter at the rear end of the catheter, the rear port including a cavity and an elastic diaphragm configured to seal the cavity, the cavity being configured to contain the flowable material and being in fluid communication with the catheter lumen.

23. The implantable device of any one of claims 16 to 20, further comprising a sensor connection circuit configured to provide access to the one or more sensors.

24. The implantable device of claim 23, further comprising a rear port connected to the elongated catheter at a rear end of the catheter, the rear port comprising a cavity and an elastic diaphragm configured to seal the cavity, the cavity being configured to contain the flowable material and being in fluid communication with the catheter lumen, wherein The sensor connection circuit is within the rear port.

25. The implantable device of claim 24, wherein: The sensor connection circuit includes a connector configured to mate with a percutaneous connector configured to provide a wired connection by piercing the resilient septum.

26. The implantable device of claim 24, wherein: The sensor connection circuit includes telemetry circuitry and a battery or inductive power receiver.

27. An implantable device kit for controllable engagement of a body lumen in tissue of a living subject, the implantable device kit comprising: An implantable device configured to control engagement of the body lumen, the implantable device comprising: an adjustable membrane element comprising a continuous wall having an inner surface defining a chamber; An elongated catheter, the elongated catheter comprising: connected to and sealed to the peripheral surface of the conduit of the adjustable membrane element; The rear end of the catheter; The front end of the catheter; a first catheter lumen extending longitudinally in the catheter from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device to adjustably expand or contract the adjustable membrane element by flowable material introduced through the first opening; and a second catheter lumen extending longitudinally within the catheter from an inlet on the catheter and an end at or near a forward end of the catheter; a sensor probe including a probe front end configured to enter the entrance of the second catheter lumen and pass through the second catheter lumen to an end of the second catheter lumen; and A plurality of sensors are incorporated into the implantable device and the sensor probe and are configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element, or a shape of the body lumen.

28. The implantable device kit of claim 27, wherein: The plurality of sensors includes at least one of an ultrasonic sensor or an optical sensor incorporated into at least one of the adjustable membrane element or the elongated catheter of the implantable device.

29. The implantable device kit of claim 27, wherein: The plurality of sensors includes at least one of an ultrasonic sensor or an optical sensor incorporated into the front end of the probe.

30. The implantable device kit of claim 27, wherein: The plurality of sensors include at least one of a pressure sensor or a strain gauge.

31. An implantable device kit for controlled engagement of a body lumen in tissue of a living subject, comprising: a sensor probe comprising a probe front end and a sensor incorporated on the probe front end, the sensor configured to detect information indicative of a degree of engagement of the body lumen; as well as An implantable device, comprising: an adjustable membrane element comprising a continuous wall having an interior surface defining a chamber, the adjustable membrane element being configured to engage the body lumen; an elongated catheter comprising a catheter peripheral surface, a catheter rear end, a catheter front end, a first catheter lumen, and a second catheter lumen, wherein the catheter peripheral surface is connected to and sealed to the adjustable membrane element at or near the catheter front end, the first catheter lumen having a first opening at the catheter rear end and a second opening in fluid communication with the chamber, the second catheter lumen being configured to receive a portion of the sensor probe including the probe front end and to allow the probe front end to be advanced to a position at or near the catheter front end for the sensor to receive a signal including information to be detected, the second catheter lumen comprising a lumen shoulder; and a rear port connected to a rear end of the catheter and comprising a lumen in fluid communication with the first opening of the first catheter, Wherein, the second catheter lumen comprises: an outlet at or near the front end of the catheter, the outlet allowing the front end of the probe including the sensor to protrude from the elongated catheter, wherein the sensor probe is configured to function as a push rod to advance the implantable device in the tissue during implantation of the implantable device, and the sensor probe includes a probe shoulder configured to abut the inner cavity shoulder to allow force applied to the sensor probe to be transmitted to the implantable device.

32. The implantable device kit of claim 31, wherein: The sensor comprises an optical sensor.

33. The implantable device kit of claim 32, wherein: The optical sensor includes a camera device.

34. The implantable device kit of claim 32, wherein: The optical sensor includes a fiber optic borescope.

35. The implantable device kit of claim 31, wherein: The sensor includes an ultrasonic sensor.

36. The implantable device kit of claim 31, wherein: The sensor is configured to detect at least one of a shape of the adjustable membrane element or a position of the adjustable membrane element.

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