阅读说明：本技术 用于监测用于尿节制的可植入装置的设备 (Apparatus for monitoring an implantable device for urinary continence ) 是由 蒂莫西·C·库克 约翰·H·伯顿 于 2020-02-14 设计创作，主要内容包括：一个或更多个传感器(2328)被并入可植入装置(2310)以及用于可植入装置的放置和/或调节的手术工具(2324)中的一个或更多个上。可植入装置包括用于身体内腔的可控接合例如尿道的接合作为尿失禁的治疗的可调节膜元件(2312)。在各种实施方式中,一个或更多个传感器可以被配置成检测指示可调节膜元件的形状、可调节膜元件相对于身体内腔的位置或身体内腔的形状中的至少一个的信息。(One or more sensors (2328) are incorporated on one or more of the implantable device (2310) and the surgical tool (2324) for placement and/or adjustment of the implantable device. The implantable device includes an adjustable membrane element (2312) for controlled coaptation of a body lumen, such as coaptation of a 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.)

1. An implantable device kit for controlled engagement of a body lumen in tissue of a living body, comprising:

an implantable device configured to control engagement of the body lumen, the implantable device comprising:

an adjustable membrane element including a continuous wall having an inner surface defining a chamber;

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

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

a sensor probe including a probe front end configured to enter the catheter lumen through a puncture septum and to reach the closed end of the catheter lumen, the sensor probe including 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, or a shape of the body lumen.

2. The implantable device kit of claim 1, further comprising an additional implantable device including an additional adjustable membrane element, and wherein the sensor probe is configured to further detect information indicative of at least one of a shape of the additional adjustable membrane element or a position of the additional adjustable membrane element.

3. The implantable device kit of any one of the preceding claims, wherein the sensor probe comprises a probe lumen configured to be in fluid communication with the chamber of the adjustable membrane element when the probe leading end is within the catheter lumen at the closed end of the catheter lumen, 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.

4. The implantable device kit of any one of the preceding claims, wherein the sensor probe is configured to be used as a pusher to advance the implantable device in the tissue during implantation of the implantable device.

5. The implantable device kit according to any one of the preceding claims, wherein the sensor comprises an optical sensor configured to sense information indicative of a shape of the adjustable membrane element.

6. The implantable device kit according to claim 5, wherein the optical sensor comprises a camera device configured to provide visualization of an inner surface of the continuous wall of the adjustable membrane element.

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

8. The implantable device kit according to any one of claims 1-4, wherein the sensor comprises an ultrasound sensor configured to provide an ultrasound image showing a shape of the body lumen and a position of the adjustable membrane element relative to the body lumen, wherein the shape of the body lumen indicates a degree of engagement of the body lumen.

9. An implantable device kit for controlled engagement of a body lumen in tissue of a living body, comprising:

a sensor probe comprising a probe front end and a sensor incorporated on the probe front end; and

an implantable device configured to control engagement of the body lumen, the implantable device comprising:

an adjustable element comprising a continuous wall having an inner surface defining a chamber;

an elongate catheter comprising a catheter peripheral surface, a catheter trailing end, a catheter leading end, a first catheter lumen, and a second catheter lumen, the catheter peripheral surface being connected to and sealed to the adjustable element at or near the catheter leading end, the first catheter lumen having a first opening at the catheter trailing 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 leading end, and the second catheter lumen is configured to allow the stylet leading end to advance to the closed end; and

a rear port connected to a rear end of the conduit, the rear port including a lumen in fluid communication with the first opening of the first conduit,

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 lumen.

10. The implantable device kit of claim 9, further comprising an additional implantable device including an additional adjustable membrane element, and wherein the sensor probe is configured to further detect information indicative of at least one of a shape of the additional adjustable membrane element or a position of the additional adjustable membrane element.

11. The implantable device kit of any one of claims 9 and 10, further comprising a pushrod configured to advance the implantable device in the tissue during implantation of the implantable device, and wherein the inlet of the second catheter lumen is configured to receive a portion of the pushrod and the second catheter lumen is configured to receive a portion of the pushrod.

12. The implantable device kit of any one of claims 9 and 10, wherein the sensor probe is configured to function as a pusher to advance the implantable device in the tissue during implantation of the implantable device.

13. The implantable device kit according to any one of claims 9-12, wherein the sensor comprises an optical sensor configured to sense information indicative of a shape of the adjustable membrane element.

14. The implantable device kit according to claim 13, wherein the optical sensor comprises a camera device configured to provide visualization of an inner surface of the continuous wall of the adjustable membrane element.

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

16. The implantable device kit of any one of claims 9-12, wherein the sensor comprises an ultrasound sensor configured to provide an ultrasound image showing at least one of a shape of the body lumen and a position of the adjustable membrane element relative to the body lumen, wherein the shape of the body lumen indicates a degree of engagement of the body lumen.

17. An implantable device configured to be implanted within body tissue adjacent a body lumen for controlled engagement of the body lumen, the implantable device comprising:

an adjustable membrane element including a continuous wall having an inner surface defining a chamber;

an elongate catheter, comprising:

a catheter peripheral surface connected to and sealed to the adjustable membrane element;

a conduit rear end;

a catheter tip; and

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

one or more sensors incorporated in 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.

18. The implantable device of claim 17, wherein the one or more sensors comprise at least one ultrasound sensor.

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

20. The implantable device of any one of claims 17-19, further comprising a posterior port connected to the elongate catheter at the catheter posterior end, the posterior port comprising a lumen configured to contain the flowable material and in fluid communication with the catheter lumen and an elastic septum configured to seal the lumen.

Technical Field

This document relates generally to implantable medical devices, and more particularly to methods and systems for monitoring placement and/or adjustment of implantable devices for treating urinary incontinence.

Background

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

Disclosure of Invention

One or more sensors are incorporated on one or more of the implantable device and the surgical tools for placement and/or adjustment of the implantable device. The implantable device includes an adjustable membrane element for controlled coaptation of a body lumen, such as coaptation of a 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.

In various embodiments, an implantable device for controlled engagement of a body lumen can 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 conduit may include a peripheral surface connected to and sealed to the adjustable membrane element, a rear end, a front end, and a lumen extending longitudinally in the elongated conduit from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the adjustable membrane element with the applied flowable material introduced through 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 status of the engagement of the body lumen. In one embodiment, the one or more sensors are incorporated on at least one of an adjustable membrane element or an elongated catheter of the implantable device. In another embodiment, the sensor probe includes a front end having a sensor incorporated therein. In one embodiment, the lumen of the elongate catheter is configured to receive a portion of the sensor probe including the forward end thereof. In another embodiment, the implantable device comprises another lumen extending longitudinally in the elongate catheter and having: an inlet configured to receive a portion of a 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 the leading end thereof. 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 producing an ultrasonic image.

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 present subject matter. Further details on the present subject matter may be found in the detailed description and the appended claims. The scope of the invention is defined by the appended claims and their legal equivalents.

Drawings

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

Fig. 2 is a longitudinal cross-sectional view of the implantable device shown in fig. 1, according to an embodiment of the present subject matter.

Fig. 3 is a cross-sectional view taken along line 3-3 of fig. 2, according to an embodiment of the present subject matter.

Fig. 4 illustrates a guide probe inserted into body tissue to an implantation position adjacent a body lumen of a patient prior to insertion of an implantable device according to an embodiment of the present subject matter.

Fig. 5 illustrates an implantable device placed over a guide probe and partially advanced to a desired position, wherein an adjustable membrane element is deflated, according to an embodiment of the present subject matter.

Fig. 6 illustrates the implant device after expansion at a desired location in the body tissue of a patient to move the body tissue toward a body lumen to cause adjustable restriction of the body lumen, according to an embodiment of the present subject matter.

Fig. 7 is a cross-sectional view taken along line 7-7 of fig. 6, according to an embodiment of the present subject matter.

Fig. 8 illustrates an implantable device after insertion with its rear port under the patient's skin, according to embodiments of the present subject matter.

Fig. 9 is a schematic view of another implantable device according to an embodiment of the present subject matter.

Fig. 10 is a schematic view of another implantable device according to an embodiment of the present subject matter.

Figure 11 is a top view illustrating a general target site for placement of an implantable device for improving engagement of the urethra according to embodiments of the present subject matter.

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

Fig. 13 is an illustration of an implantable device and a sensor probe according to an embodiment of the present subject matter.

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

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

Fig. 16 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.

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.

Fig. 18 is an illustration of an implantable device having one or more sensors according to an embodiment of the present subject matter.

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

Fig. 20 is an illustration of engagement of a body lumen using an implantable device according to an embodiment of the present subject matter.

Fig. 21 is an illustration of engagement of a body lumen using two implantable devices according to an embodiment of the present subject matter.

Fig. 22 is an image showing two implantable devices implanted in a patient adjacent a body lumen for engagement of the body lumen, according to embodiments of the present subject matter.

Fig. 23 is an illustration of a single lumen implantable device and sensor probe according to an embodiment of the present subject matter.

Detailed Description

The following detailed description of the present subject matter refers to the subject matter in the accompanying drawings that show, 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 present subject matter. References to "an," "one," or "various" embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is illustrative and is not to be taken in a limiting sense. The scope of the present subject matter is defined by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.

This document discusses, among other things, 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 the rear port, such as by a catheter having an inner lumen providing fluid communication between a lumen of the adjustable membrane element and a lumen of the rear port. The various structural elements of implantable devices discussed in this document (e.g., implantable device 110 shown in fig. 1) may be referred to by various terms. An "adjustable membrane element" (such as adjustable membrane element 112 shown in fig. 1) may also be referred to as, for example, an adjustable element, an expandable membrane element, a forward-expandable membrane element, a balloon, or an adjustable balloon. A "catheter" (e.g., catheter 114 shown in fig. 1) may also be referred to as, for example, a central catheter element, a device catheter, a connecting conduit, or a tubular elongate body. A "rear port" (e.g., rear port 116 shown in FIG. 1) may also be referred to as, for example, a rear port portion or rear port element. "lumens" (e.g., the first lumen 215 and the second lumen 217 shown in fig. 2) may also be referred to as channels, internal channels, or internal channels, for example.

In one example, the implantable device includes an adjustable balloon connected to the port with a catheter. The balloon is placed adjacent the urethra to apply non-circumferential compression to the urethral wall. The effectiveness of the therapy depends on the correct positioning of the balloon within the patient's body, for example in the retropubic space (resulting from radical prostatectomy) near the urethrovesical anastomosis above the urogenital septum close to the urethral wall. When two balloons are used (e.g., of two implantable devices), their preferred locations are generally symmetrical and transverse to the urethra. Fluoroscopy or transrectal ultrasound may be used to visually monitor the position of the balloon during implantation of the implantable device. Fluoroscopy has become a standard technique, but it exposes the patient to radiation and provides a two-dimensional view that in some cases makes viewing difficult. For example, when the patient is on the operating table, the fluoroscopic image does not show the position of the balloon on the anterior-posterior plane, and therefore does not show whether the balloon is properly positioned to apply pressure to the urethral wall. Transrectal ultrasound (TRUS) can provide better visualization (e.g., location of the balloon in the anterior-posterior plane), but requires the surgeon to be familiar with this imaging technique. During the implantable procedure, the implantable device is initially placed within 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 dislodgement from the target space. After packaging, the patient will undergo one or more adjustment procedures during which the balloon is adjusted to achieve and maintain the urogenital control without causing undesirable obstruction.

The present subject matter monitors placement and/or adjustment of an implantable device using one or more sensors incorporated on the implantable device and/or on a surgical tool used to implant the implantable device. This monitoring technique avoids the use of fluoroscopy or transrectal ultrasound and its disadvantages, such as exposure to the rectal insertion of an X-ray or ultrasound probe. In one embodiment, the one or more sensors comprise one or more ultrasonic transducers on the implantable device and/or surgical tool, allowing the use of ultrasonic imaging to monitor balloon placement and adjustment during device implantation. An ultrasound sensor on the implantable device may further allow for post-operative adjustment of the balloon.

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 may also be used to monitor various conditions of the urethra, which may indicate the amount of compression resulting from the degree of expansion of the balloon, such as over-compression resulting from over-inflation of the balloon, sufficient compression (the target of treatment), and under-compression resulting from under-inflation of the balloon. The goal of the treatment is to provide the patient with continence without undesirable obstruction, and this requires the correct amount of coaptation of the urethra created by placing the balloons in the correct position and giving each balloon the correct amount of inflation. The present subject matter allows for the determination of the correct location and the correct amount of inflation for each balloon.

Fig. 1-10 illustrate various embodiments of implantable medical devices and surgical tools. The surgical tool includes an elongated body and may serve as a base device upon which one or more sensors may be incorporated. Implantable medical devices may be used with surgical tools that include sensors or may serve as a base device upon which one or more sensors may be incorporated. Various embodiments of implantable devices and surgical tools are shown in fig. 1-10 and discussed 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. patent No. 5,964,806, U.S. patent No. 6,045,498, U.S. patent No. 6,419,624, U.S. patent No. 6,579,224, and U.S. patent No. 8,926,494, all assigned to uromedical, inc. Fig. 11-23 illustrate various embodiments of one or more sensors incorporated on implantable devices and/or surgical tools such as those discussed in the documents.

In accordance with the present subject matter as illustrated by fig. 1, an elongated implantable device 110 is provided that includes an adjustable membrane element 112 shown in its fully expanded size, and is compressively attached to an elongated catheter 114, the elongated catheter 114 being connected to a rear port 116 in communication with the expandable element 112 through a first lumen 215 (see fig. 2). The catheter 114 has a pointed leading end 114A that extends slightly beyond the expansible member 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 through the rear port 116 into the implantable device 110 to expand the adjustable membrane element 112.

As further shown in fig. 2 and 3, the catheter 114 contains two elongated lumens or channels. The first lumen 215 provides an internal channel through which flowable material is directed from a lumen 216A in the rear port 116 to expand the adjustable membrane element 112. The conduit 114 is integrally attached at its rear end to a rear port 116. The second lumen 217 extends from the anterior opening 117A to the posterior opening 117B and is used to receive an elongated guide probe (see fig. 4) and effect delivery of the implantable device 110 to a desired location in the body tissue of the patient.

Important features of the implantable device 110 having a first lumen 215 include a first open port 215A, the first open port 215A being located in the lumen 216A of the rear port 116 between the resilient partition 218 and the conduit 114 and being connected to the first lumen 215 such that flowable material can be injected through the first open port 215A and a second port 215B for directing working fluid to the adjustable membrane element 112. During adjustment of the volume of membrane fluid provided from the hollow needle 121 of the syringe 120, the membrane fluid is injected through the septum 218 and continues through the conduit 114 connected to the adjustable membrane element 112. Rear port 116 preferably has a larger diameter than conduit 114 to accommodate chamber 216A and septum 218, septum 218 being securely retained by clamp ring 119.

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 may be formed as a unitary structure. Alternatively, the adjustable membrane element 112, the rear port 116 and the conduit 114 may be molded as one piece. As shown in fig. 2, the adjustable membrane element 112 is adhered at 213 to the conduit 114 at its forward end by a suitable adhesive material.

Implantable devices and assemblies according to the present subject matter can include three primary components. The first member provided is an elongated guide in the form of a rigid solid elongated guide probe 424 (see fig. 4) configured for delivering the implantable device 110 to a desired site in a body tissue of a patient, as generally shown by fig. 4 and 5. Alternatively, the elongate guide member may be in the form of a flexible guide wire which has been initially delivered into the body tissue by a separate hollow rigid probe which has been inserted into the body tissue at the desired location. The second component of the assembly is an implantable device 110 that includes an adjustable membrane element 112, a catheter 114 containing two lumens 215 and 217, and a rear port 116. During implantation thereof, after the elongate solid introducer probe 424 is first surgically inserted into the body tissue of the patient to establish an initial passageway, the implantable device 110 is introduced to a predetermined location adjacent to a body lumen in the body of the patient. The lumen leading end opening 117A of the implantable device 110 is then disposed over the trailing end of the introducer probe 424 to guide the implantable device 110 and deliver the adjustable membrane element 112 (in its collapsed shape) to a predetermined location adjacent the lumen to be adjustably restricted in the body tissue. The diameter of the second lumen 217 is made slightly larger than the diameter of the introducer probe 424 to allow the implantable device 110 to easily slide over the probe member.

During implantation of the implantable device 110, the physician may first make a small incision in the skin 430 near the body lumen 432 that the patient needs to circumscribe, and then guide the solid guide probe 424 to a desired location according to the patient's anatomy by visualization means 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 introducer probe 424 with the adjustable membrane element 112 in its initial deflated or collapsed state. The introducer probe 424 slides through the second lumen 217 of the catheter 114 and exits at the rearward opening 117B. As shown in fig. 2, opening 117B is between adjustable membrane element 112 and 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.

If desired, a marker 533 may be provided on the guide probe 424, which marker 533, when aligned with a feature 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 near the skin of the patient. Alternatively, the effective length of the conduit 114 may be made adjustable by its helical shape having a helical shape similar to that of a coil spring.

After the implantable device 110 has been advanced over the introducer probe 424 such that the collapsed adjustable membrane element 112 is in a desired position adjacent the body lumen 432, the body lumen 432 can be restricted to a desired degree by piercing the septum 218 with the needle 121 of the syringe 120 and injecting 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 fluid through the body lumen past the restriction and measuring back pressure.

As shown by fig. 1 and 6, the source of flowable material is typically a syringe 120 with a hollow needle for piercing the elastomeric septum 218. However, alternative fluid reservoirs having means for reversibly connecting with 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 inflation of the membrane can be viewed by X-ray.

An alternative method of delivering the implantable device 110 may be to first withdraw the introducer probe 24 from the body tissue and then inflate the adjustable membrane element 112. Another alternative is to first place the implantable device 110 over a solid introducer 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 need to exist between the solid introducer probe 424 and the second lumen 217 in the catheter 114.

After the implantable device 110 has been properly positioned with the adjustable membrane element 112 positioned adjacent the body lumen 432 and the septum 218 in the rear port 116 positioned adjacent the skin 430, the device is injected with flowable material from the injector 120. The expandable member may be inflated to a certain extent and then deflated to an extent suitable for encapsulating the expandable member by body tissue. The introducer probe 24 is then withdrawn from the device leaving the slightly enlarged membrane element in the body tissue. The skin incision 431 is then closed over the port 116, such as by suture 834, as shown in FIG. 8.

The present subject matter provides adjustability of post-operative membrane expansion for the implantable device 110. This adjustability is achieved because the partition 218 is positioned away from the adjustable membrane element 112 but near and below the skin of the patient. The port and septum are positioned by, for example, manual palpation of the skin area, and the needle of the 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.

To ensure proper sealing of the diaphragm 218, the diaphragm 218 is placed in compression within the cavity 216A by providing a tight metal ring 119 around 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 expansion or adjustment of the adjustable membrane element 112, there is a positive seal around the perimeter of the septum 218.

Fig. 4-8 generally illustrate a method or procedure for properly implanting an implantable device 110 in body tissue of a patient. As shown by fig. 4, after positioning a body lumen, such as the urethra, of a patient, the physician makes a small incision 431 and inserts the introducer probe 424 into the body tissue to a desired location adjacent the body lumen 432. The procedure is typically performed by a physician under local anesthetic with visual guidance, e.g., under fluoroscopy. Next, the physician holds the implantable device 110 and places it over the introducer probe 424 through the second lumen 217 as shown in FIGS. 1 and 2. The guide probe 424 enters the rear opening 117B and exits the front opening 117A. With the catheter 114 sufficiently flexible, the implantable device 110 is advanced along the introducer probe 424 and into the body tissue.

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, the syringe 120 having a hollow needle 121 inserted through the septum 218 to at least partially expand the adjustable membrane element 112, as shown by FIG. 6. Next, the introducer probe 424 is removed and the adjustable membrane element 112 is further expanded to a desired enlarged size for confinement of the body lumen 432. The injector 120 is removed from the implantable device 110, after which the adjustable membrane element 112 of the desired size is retained by the resilient membrane 218. Next, the patient's incision at 431 is surgically closed over port 116 and septum 218 by suture at 834.

Fig. 9 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 in the catheter 914 from a first opening 915A at a rear end (also referred to as a proximal end) 962 to a second opening 915B, and wherein the implantable device 910 is shown positioned within a channel 944 of a sheath 946.

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 are known in the art. In further embodiments, the rear port 916 and rear end 962 are formed together in a polymer molding process, such as liquid injection molding as is known in the art.

The rear port 916 includes a lumen 916A, wherein the lumen 916A is in fluid communication with a first opening 915A of the catheter 914. In one embodiment, the rear port 916 further comprises a resilient septum 918, through the resilient septum 918 into the cavity 916A, wherein the resilient septum 918 is sealable after repeated punctures, such as with a needle. In one embodiment, the resilient diaphragm 918 is retained in the rear port 916 by a clamping ring 919 positioned 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 resilient membrane 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 millimeters, with 4.5 millimeters being a specific example.

In one embodiment, the outer surface of the rear port 916 and the adjustable membrane element 912 have a dimension (e.g., diameter) that is smaller than an interior dimension (e.g., diameter) of the passage 944 to allow the implantable device 910 to move longitudinally through the passage 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 dimensions of the rear port 916 in its relaxed state to be compressed to a size small enough that the implantable device 910 can be moved longitudinally through the passage 944 of the sheath 946. In various embodiments, the catheter 914 is sufficiently rigid to allow a force applied at the trailing end of its tubular elongate body to move the implantable device 910 at least partially through the channel 944 of the sheath 946. In one embodiment, the stiffness of the catheter 914 is determined based on the type of material used to construct its tubular elongate body. Alternatively, a support element may be added to the tubular elongate body. For example, a metal coil may be placed longitudinally within the tubular elongate body to increase the rigidity of the tubular elongate body.

Once the implantable device 910 is positioned within the body, the adjustable membrane elements 912 are inflated by releasably connecting a source of flowable material to the rear port 916. In one embodiment, the flowable material source comprises a syringe having a coreless needle inserted through the resilient membrane 918. A measured fluid volume supply can be introduced into the implantable device 910 and the adjustable membrane element 912 can expand or contract due to the volume of flowable material introduced into the cavity 916A of the rear port 916 from the source of flowable material. The adjustable membrane elements 912 are then used to at least partially and adjustably restrict the body lumen. Fluids suitable for injecting the prosthesis include, but are not limited to, sterile saline solution; polymer gels, such as silicone gels or hydrogels of, for example, polyvinylpyrrolidone, polyethylene glycol, carboxymethylcellulose; high viscosity liquids such as hyaluronic acid, dextran, polyacrylic acid, polyvinyl alcohol or radiopaque fluids for example. Once the adjustable membrane element 912 has been inflated, the needle is withdrawn from the septum of the rear port 916. In additional embodiments, the detectable marker 970 is embedded in a continuous wall of the adjustable membrane element 912. Detectable marker 970 allows adjustable membranous element 912 to be positioned within a 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, detectable marker 970 comprises tantalum and the visualization technique used to visualize adjustable membrane element 912 is X-ray or fluoroscopy as is known in the art.

In further embodiments, a detectable marker is embedded in the implantable device 910. For example, the detectable marker 970 is located at the forward end (also referred to as distal end) 960 (e.g., tip) of the catheter 914. Alternatively, the detectable marker can be located in a continuous wall of the adjustable membrane element 912. Detectable marker 970 allows for any number of visualization techniques using electromagnetic energy as a means of locating objects in the body to be used by front end 960 or adjustable membrane element 912. In one embodiment, detectable marker 970 comprises tantalum and the visualization technique used to visualize front end 960 or adjustable membrane element 912 is X-ray or fluoroscopy as known in the art. In further embodiments, the sheath may also have a detectable marker, wherein the marker may be incorporated into or on the sheath wall. Alternatively, the entire sheath may be constructed to be radiopaque.

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 conduit 1014 has a forward end 1060. In one embodiment, the outer peripheral surface of the conduit 1014 is attached to and sealed to an adjustable membrane element 1012. In one embodiment, the adjustable membrane element 1012 includes a continuous wall having an inner surface defining a chamber.

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., two openings as shown in fig. 10). The second opening 1015B is in fluid communication with a chamber of the adjustable membrane element 1012 to adjustably expand or contract the adjustable membrane element 1012 with a flowable material introduced through the first opening 1015A.

The second lumen 1017 extends longitudinally along the conduit 1014 from the inlet 1017B to a closed end 1017A at a front end 1060. In one embodiment, the second lumen 1017 and the inlet 1017B each have a sufficient diameter to receive a push rod that may be used to advance the implantable device 1010 in tissue.

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 a resilient septum 1018. The cavity 1016A is coupled to the first lumen 1015 at the first opening 1015A and is in fluid communication with the first lumen 1015. The resilient septum 1018 allows for needle over-travel to the chamber 1016A for introducing and/or withdrawing fluid to expand and/or withdraw the adjustable membrane element 1012.

Fig. 11 is a top view of a bladder 1101 and urethra 1102 illustrating an approximate target location for placement of an implantable device 1110 to improve the coaptation of the urethra according to an embodiment of the present subject matter. The implantable device 1110 can exhibit any embodiment of an implantable device as discussed in this document (where an expandable membrane element or an adjustable membrane element is shown to illustrate its position), including but not limited to implantable device 110, implantable device 910, implantable device 1010, or implantable devices including various combinations of features of implantable devices 110, 910, and 1010. A cartesian coordinate system having X, Y and Z axes is shown in fig. 11-21 (where two of the X, Y and Z axes are seen in each of these figures) as a reference for exemplary orientations of the structures shown in these figures. The orientation of the Z-axis is along the urethra 1002 in the direction of the approximate location of implantation. In the case of radical prostatectomy, this location is near the bladder neck and urethral bladder anastomosis, or further down the urethra at the apex of the prostate following transurethral prostatectomy (TURP).

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

Fig. 13 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 sensor probe 1324 may be provided as a device kit that may also include other accessories. The implantable device 1310 can be used to engage a lumen within a 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 lumen and includes a continuous wall having an inner surface defining a chamber. The conduit 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 a lumen (not shown in fig. 13) extending longitudinally along the conduit 1314 from a first opening at the rear end 1315 to a second opening at or near the front end 1313 in fluid communication with the chamber. 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 interior cavity and a resilient septum that allows access to the chamber through the needle. In some embodiments, the rear port 1316 is releasably coupled to the rear end of the catheter 1314. The implantable device 1310 may represent any embodiment of an implantable device as discussed in this document, including but not limited to implantable device 110, implantable device 910, implantable device 1010, or implantable devices including various combinations of features of implantable devices 110, 910, and 1010.

The 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 on the elongated body 1326. In various embodiments, the sensor probe 1324 can be incorporated into any surgical tool having an elongated body that is used during implantation and/or adjustment of the implantable device 1310 by incorporating a sensor. Examples of such surgical tools include a push rod (e.g., push rod 1450) and a guide probe (or guide rod or wire, such as guide probe 424). In one embodiment, as shown in FIG. 13, one sensor 1328 is shown at the front end 1325. In another embodiment, as shown in fig. 14, which illustrates a portion of a sensor probe 1424, a plurality of sensors 1328 are distributed over at least a portion of an elongated body 1326, according to embodiments of the present subject matter.

In various embodiments, the sensor 1328 can be rotated by rotating the elongated body 1326, such as by rotating the rear end 1327. The elongated body 1326 may 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 circuitry 1330. In one embodiment, the sensor connection circuitry 1330 includes a connector for connecting to an external system that processes signals sensed by the sensor 1328. In another embodiment, the sensor connection circuit 1330 includes a telemetry circuit and a battery so that it can communicate wirelessly with an external system. The telemetry circuitry may perform wireless communication using, for example, electromagnetic, magnetic, acoustic, or optical telemetry.

In various implementations, the sensor 1328 may include one or more ultrasonic transducers that each convert an electrical input signal to ultrasound, transmit the ultrasound, receive reflected ultrasound (echoes of the transmitted ultrasound), and convert the received reflected ultrasound to an electrical image signal. The external system may receive the electrical image signal and generate an ultrasound image based on the electrical image signal. The one or more ultrasonic transducers may each comprise a piezoelectric transducer or a capacitive transducer, and each have an ultrasonic beam direction and an ultrasonic beam angle.

In various implementations, the sensor 1328 can 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 a captured image into an electrical image signal. The external system may receive the electrical image signal and generate a visual image based on the electrical image signal.

In various embodiments, the lumen of the implantable device 1310 in fluid communication with the chamber is also configured to receive a sensor probe 1324 that functions as a push rod (e.g., as shown in fig. 9). The end of the lumen at the leading end 1313 is configured to receive a force applied through the sensor probe 1324 to move the implantable device 1310. The interior chamber includes a closed end near the front end 1313. The closed end has sufficient strength and rigidity to receive the forward end 1325 of the sensor probe 1324 and transmit the force applied at the rearward end 1327 of the sensor probe to the implantable device 1310.

In various other embodiments, the first lumen of the implantable device 1310 is in fluid communication with the chamber to regulate 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., as shown in fig. 2, 3, 5, and 10). The second lumen includes an inlet at or near the trailing end 1315 of the catheter 1314 and an outlet at or near the leading end 1313 of the catheter 1314. The leading end 1313 is configured to receive a force applied through the sensor probe 1324 to move the implantable device 1310.

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

In another embodiment, the sensor probe 1324 includes a sharp tip adapted to penetrate tissue, as in the example shown in FIG. 10. Fig. 15 is a diagram illustrating a front end 1525 of a sensor probe 1524 according to an embodiment of the present subject matter. Sensor probe 1524 may represent an example of sensor probe 1324 and include a sharp tip 1531 at a front end 1525. The second lumen includes an outlet near the forward 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 is a cross-sectional view of a portion of the leading end 1713 of an elongate catheter 1714 according to an embodiment of the present subject matter. Front end 1713 may represent an example of front end 1313. The second lumen includes a first shoulder 1736 and the sensor probe 1524 includes a second shoulder 1532, the second shoulder 1532 configured to abut the first shoulder 1736 to allow transmission of forces applied at the rear end 1327 of the sensor probe 1324 to the implantable device 1310. In one embodiment, as shown in fig. 15 and 17, first shoulder 1736 is formed by a change in diameter of the second lumen, and second shoulder 1532 is formed by a change in diameter of sensor probe 1524. The sensor 1328 can be incorporated onto the elongate body 1526 of the sensor probe 1524 at the leading end 1525 such that both the sharp tip 1531 and the sensor 1328 can protrude from the catheter 1314 of the implantable device 1310.

Fig. 18 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 on the implantable device 1310. The implantable device 1810 also includes sensor interface circuitry 1840, e.g., at the trailing end 1315, and a conductor 1841 extending within the elongate body 1314 to provide a connection between the sensor 1828 and the sensor interface circuitry 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 posterior connection between the adjustable membrane element 1312 and the catheter 1314, and along a midline of the adjustable membrane element 1312 that is perpendicular to the catheter (i.e., perpendicular to the Z-axis). In various embodiments, any number of sensors are incorporated at any location on the implantable device 1810. For example, the one or more sensors 1828 can be incorporated on the conduit 1314 (e.g., at or adjacent the front end 1313, at or adjacent the distal connection between the adjustable membrane element 1312 and the conduit 1314, and/or at or adjacent the rear connection between the adjustable membrane element 1312 and the conduit 1314) and/or the adjustable membrane element 1312 (e.g., on a centerline perpendicular to the adjustable membrane element 1312 of the conduit 1314, adjacent the distal connection between the adjustable membrane element 1312 and the conduit 1314, and/or adjacent the rear connection between the adjustable membrane element 1312 and the conduit 1314).

In various implementations, the sensor 1828 may include one or more ultrasonic transducers that each convert an electrical input signal to ultrasound, transmit the ultrasound, receive reflected ultrasound (echoes of the transmitted ultrasound), and convert the received reflected ultrasound to an electrical image signal. The external system may receive the electrical image signal and generate an ultrasound image based on the electrical image signal. The one or more ultrasonic transducers may each comprise a piezoelectric transducer or a capacitive transducer, and each have an ultrasonic beam direction and an ultrasonic beam angle. Multiple ultrasound transducers may be arranged on the implantable device 1810 to provide a specified overall ultrasound beam angle (e.g., 90, 180, 270, or 360 degrees).

In various implementations, 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. The external system may receive the electrical image signal and generate a visual image based on the electrical image signal.

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

Sensor connection circuitry 1840 may 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 may communicate with an external system using a wired connection. The sensor link circuit 1840 includes a connector. The external system includes a percutaneous connector to pierce the resilient septum of the rear port 1316 and mate with a connector in the rear port 1316. In another embodiment, the implantable device 1810 may communicate with an external system in a wireless manner. The sensor link circuit 1840 includes a telemetry circuit and a battery or inductive power receiver. The telemetry circuit may transmit power to the implantable device 1810 and receive sensed signals from the implantable device 1810.

Fig. 19 is an illustration of an implantable device set 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, as shown in fig. 19, and may also include other tools or accessories for implantation of the implantable device 1810. One or more sensors selected from sensor 1828 and sensor 1328 may be used to provide monitoring of the implantable device 1810 during implantation and/or adjustment. For various purposes and circumstances, the user may monitor using one or more sensors of only the implantable device 1810, one or more sensors of only the sensor probe 1324, or sensors of both the implantable device 1810 and the sensor probe 1324.

Fig. 20 is an illustration of the engagement of a body lumen 1102 using an implantable device 2010 and a probe 2024, according to an embodiment of the present subject matter. Examples of implantable device 2010 include, but are not limited to, any of the implantable devices discussed in this document (with or without one or more sensors), such as implantable devices 110, 910, 1010, 1310, and 1810. Examples of probes 2024 include, but are not limited to, any of the probes (with or without one or more sensors) discussed in this document, such as guide probe 424, pusher bar 1450, and sensor probes 1324, 1424, and 1524. The sensor 2028 is representative of any one or more sensors incorporated on the implantable device 2010 and/or the probe 2024. In one embodiment, the sensor 2028 provides an image such as the image shown in fig. 22 for guiding placement of the implantable device 2010 adjacent to the lumen 1102 (e.g., urethra) to achieve coaptation of the lumen, and/or to allow determination of whether a body lumen is coaptated to a desired degree.

Fig. 21 is an illustration of the engagement of a body lumen 1102 using two implantable devices 2010 and two probes 2024, according to an embodiment of the present subject matter. Fig. 22 shows an example of an image of this therapy. When the body lumen (e.g., urethra) was properly engaged, the lumen-facing adjustable membrane elements 1312 of each implantable device were observed to flatten. In various embodiments, sensors 2028 can be used to provide images and/or other information indicative of the position of each of implantable devices 2010, the degree of flattening of adjustable membrane elements 1312, and/or the shape of the body lumen, thereby providing guidance when placing and/or adjusting implantable devices 2010. The shape of the body lumen may 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 a shape of the adjustable membrane element 1312 of the same implantable device, a position of the adjustable membrane element 1312 of the same implantable device (e.g., relative to the body lumen 1102), a shape of the adjustable membrane element 1312 of another implantable device 2010, a position of the adjustable membrane element 1312 of another implantable device 2010 (e.g., relative to the body lumen 1102), and/or a 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 proximate to the implantable device 2010.

Fig. 23 is an illustration of an implantable device kit 2320 including a single lumen implantable device 2310 and a sensor probe 2324, in accordance with an embodiment of the present subject matter. The implantable device kit 2320 may represent an example of an implantable device kit 1320 in which 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 state or extent of engagement of the urethra and adjust the volume in the adjustable membrane element 2312 of the implantable device 2310 for optimal efficacy in treating urinary incontinence without causing obstruction of the urethra. The implantable device 2310 includes a forward end 2360, a rearward port 2316, and an elongate catheter 2314 coupled between the forward end 2360 and the rearward port 2316. An adjustable membrane element 2312 is secured to catheter 2314 near 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 lumen of the adjustable membrane element 2312 at the distal opening 2315B and with the lumen 2316A of the rear port 2316 at the rear opening 2315A. In the illustrated embodiment, sensor probe 2324 is a three-in-one device that can also be used as: (1) a sensing device comprising a sensor 2328 at a forward end of the sensor probe 2324, (2) a push rod for advancing the implantable device 2310 in tissue by applying a force to a closed forward end of the lumen 2315 at a forward end 2360, and (3) a hollow needle comprising a lumen 2365 through which a fluid can be introduced and withdrawn to inflate and deflate, respectively, the adjustable membrane element 2312 through a distal opening 2315B of the lumen 2315. The internal cavity 2315 is configured to receive a forward portion of the sensor probe 2324, with a forward end of the sensor probe 2324 reaching a closed forward end of the internal cavity 2315. As shown in FIG. 23, when the adjustable membrane elements 2312 are placed adjacent to the urethra and deflated, pressure from the urethra can flatten one side of the adjustable membrane elements 2312. Sensor 2328 may allow such flattening to be observed, which indicates the amount of pressure that may be adjusted for optical efficacy in treating urinary incontinence.

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

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 intraurethral coaptation. In another embodiment, sensor 2328 is an ultrasonic sensor. In addition to direct visualization of the junction of the urethra, the ultrasound sensor may also allow visualization of the adjustable membrane element 2312 relative to anatomical structures such as the bladder neck and rectum if it transmits ultrasound with sufficient penetration depth within the tissue. Such visualization may be used to aid in the placement of the adjustable membrane element 2312 during implantation of the implantable device 2310. In various embodiments, the sensor 2328 may include any type of sensor that allows for detection of flattening of the adjustable membrane element 2312 and/or visualization of the adjustable membrane element 2312 in tissue relative to various anatomical structures.

In the illustrated embodiment, the sensor 2328 (i.e., optical sensor) includes a flattened optical sensing element 2361 for viewing the adjustable membrane element 2312 with 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 the electrical heating wire 2364. The electrical heating wire 2364 may also be used to power a light source such as an LED to aid visualization (it is not necessary if the chip 2362 is an infrared CCD or CMOS chip). The sensor probe 2324 can be rotated about its longitudinal axis within the lumen 2315 to scan circumferentially to find a maximum engagement point at which the membrane element 2312 can be adjusted to flatten. Rotating the sensor probe 2324 may also help to pass it through bends in the catheter 2314, particularly when the rear port 2316 is directed into the scrotum or labia. For at least this reason, sensor probe 2324 is provided with a certain amount of flexibility. In one embodiment, the sensor probe 2324 with 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.

In another embodiment, sensor probe 2324 may include a borescope for optical visualization, wherein a fiber optic bundle extends through the sensor probe. A light source within sensor probe 2324 is not necessary as an optical fiber may also be used to transmit light from a light source externally connected to the sensor probe. The fiber bundle may have a significantly smaller diameter when compared to the size of a CCD or CMOS chip, thereby reducing the diameter of the sensor probe 2324 and, therefore, the catheter 2314 and rear port 2316. This allows for a reduction in the overall size of the implantable device 2310 and the overall size of the sensor probe 2328. The smaller diameter of the sensor probe 2324 is desirable because after the implantable device is implanted in the patient, the sensor probe 2324 must pass through the skin of the scrotum or labia to reach the rear port 2316 of the implantable device. Furthermore, the fiber optic implementation of sensor probe 2324 may reduce production costs when compared to optical sensor implementations with CCD or CMOS chips, thereby improving the affordability of making sensor probe 2324 a disposable device.

This application is intended to cover adaptations or variations of the present subject matter. It is to be understood that the above description is intended to be illustrative, and not restrictive. The scope of the present subject matter should be determined with reference to the appended claims, along with the full scope of legal equivalents to which such claims are entitled.