Implantable urine suppression device with spiral anchor

Abstract

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

Description

Technical Field

[0001] This specification generally relates to implantable medical devices, and more particularly to devices having a helix for anchoring to tissue after implanting a device for treating urinary incontinence in a patient.

Background Art

[0002] 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 conduit. The implantable device can be implanted in a patient by minimally invasive surgery with the adjustable membrane element disposed adjacent to the patient's urethra and the rear port disposed under the patient's skin. The adjustable membrane element can be adjusted during and after surgery by injecting fluid percutaneously into the rear port using a needle or by extracting fluid from the rear port. In an exemplary treatment, two such implantable devices are placed within a patient so that the two adjustable membrane elements provide compression and support to the patient's bladder neck to protect against accidental leakage of urine, such as in cases of stress urinary incontinence (e.g., leakage during sneezing, coughing, or physical activity). The effectiveness of this treatment depends on the accurate placement of the adjustable membrane element at the target site within the patient, the adjustment of the adjustable membrane element after placement, and the maintenance of the position of the adjustable membrane element over time.

Summary of the Invention

[0003] The implantable device includes a conduit, an adjustable membrane element coupled to the conduit near its anterior end for controllable junction of a body lumen, such as urethral coaptation as a treatment for urinary incontinence, and a helical body coupled to the anterior end of the conduit. The helical body functions as a fixation mechanism for securing the implantable device to tissue. The implantable device can be inserted into tissue using a sheath, and the adjustable membrane element located at the anterior end of the sheath can be rotated with the sheath by partially inflating it, and the helical body can be rotated into the tissue by rotating the sheath.

[0004] This summary is a partial summary of the teachings of this application and is not intended to be an exclusive or exhaustive representation of the subject matter. Further details relating to the subject matter are found in the modes for carrying out the invention and the appended claims. The scope of the invention is defined by the appended claims and their legal equivalents. [Brief explanation of the drawing]

[0005] [Figure 1] This is a perspective view of an implantable device and a syringe source for providing a fluid material to an adjustable membrane element of the implantable device, according to an embodiment of the subject. [Figure 2] Figure 1 is a longitudinal cross-sectional view of an implantable device according to an embodiment of the subject of this paper. [Figure 3] This is a cross-sectional view along line 3-3 in Figure 2, according to an embodiment of the subject of this paper. [Figure 4] Figure 1 shows the implantable device according to an embodiment of this subject, after it has been placed in a desired location within a patient and expanded to displace body tissue toward a body lumen to cause adjustable restraint of the body lumen. [Figure 5] This is a longitudinal cross-sectional view of another implantable device according to an embodiment of the subject. [Figure 6] This is a cross-sectional view along line 6-6 in Figure 5, according to an embodiment of the subject of this paper. [Figure 7] This shows a sheath used for implanting an implantable device according to an embodiment of this subject. [Figure 8] The trocar used with the sheath shown in Figure 7, according to the embodiment of this subject, is shown. [Figure 9] The assembly of the sheath shown in Figure 7 and the trocar shown in Figure 8 according to the embodiment of this subject is shown. [Figure 10] This figure, including a cutaway view, illustrates the introduction of an implantable device into patient tissue to provide urethral connection using the sheath of Figure 7 and the trocar assembly of Figure 8, according to an embodiment of the subject. [Figure 11] This figure, including a cutaway view, shows a pair of implantable devices placed in a patient to provide urethral connection according to an embodiment of the subject. [Figure 12] This figure, including a cutaway view, shows the adjustment of the urethral connection after a pair of implantable devices, according to an embodiment of the subject, have been placed in a patient as shown in Figure 11. [Figure 13] This figure shows an implantable device, a push wire, and a sheath according to an embodiment of the subject of this subject. [Figure 14] This is a diagram of another implantable device, push wire, and sheath according to an embodiment of the subject matter. [Figure 15] This figure illustrates a method for placing an implantable device in a patient using a sheath, according to an embodiment of this subject. Figure 15 shows an implantable device partially placed within the sheath. [Figure 16] Figure 16 shows a method for placing an implantable device in a patient using a sheath, according to an embodiment of the subject. The adjustable membrane element of the implantable device is advanced into the anterior part of the sheath and partially inflated to allow the helical body of the implantable device to rotate and enter the tissue. [Figure 17]This figure illustrates a method for placing an implantable device in a patient using a sheath, according to an embodiment of this subject. Figure 17 shows the sheath partially extended to allow expansion of an adjustable membrane element. [Figure 18] Figure 18 shows a method for placing an implantable device in a patient using a sheath, according to an embodiment of this subject. Figure 18 shows an adjustable membrane element being inflated for joining with the patient's body lumen. [Figure 19] Figure 19 shows a method for placing an implantable device in a patient using a sheath, according to an embodiment of this subject. Figure 19 shows the sheath being pulled out to allow the sheath to be separated from the implantable device. [Figure 20] This figure shows scenarios for performing the methods shown in Figures 15-19 according to embodiments of this subject, and the device features associated with those scenarios. Figure 20 shows the adjustable membrane elements of the implantable device protruding from the slots in the sheath. [Figure 21] Figure 21 shows scenarios for performing the methods shown in Figures 15-19 according to embodiments of this subject, and device features associated with those scenarios. [Modes for carrying out the invention]

[0006] The following detailed description of the subject matter refers to the subject matter in the accompanying drawings, which illustrate specific modes and embodiments in which the subject matter may be carried out. These embodiments are described in sufficient detail so that a person skilled in the art can carry out the subject matter. References to “an,” “one,” or “various” embodiments in this disclosure do not necessarily refer to the same embodiment, and such references intend to describe two or more embodiments. The following detailed description is illustrative and should not be construed as restrictive. The scope of the subject matter is defined by the accompanying claims, together with the entire scope of legal equivalents to which such claims are granted.

[0007] This specification, in particular, discusses mechanisms and tools for securing implantable devices to surrounding tissues for the treatment of urinary incontinence. The implantable device may include, for example, an adjustable membrane element connected to a posterior port by a conduit, the conduit having a lumen that provides fluid communication between the chamber of the adjustable membrane element and the internal cavity of the posterior port. Various structural elements of the implantable device described herein (e.g., implantable device 110 shown in Figure 1) may be referred to by various terms. The “adjustable membrane element” (e.g., adjustable membrane element 112 shown in Figure 1) may also be referred to, for example, an adjustable element, expandable element, expandable membrane element, forward expandable membrane element, balloon, or adjustable balloon. The “conduit” (e.g., conduit 114 shown in Figure 1) may also be referred to, for example, a central conduit element, device conduit, connecting conduit, connecting conduit tube, or tubular elongated body. The “posterior port” (e.g., posterior port 116 shown in Figure 1) may also be referred to, for example, a posterior port portion or posterior port element. The "lumens" (for example, the first lumen 115 and the second lumen 117 shown in Figure 2) may also be referred to, for example, as passages, internal passages, or internal passages.

[0008] In one example, the implantable device includes an adjustable balloon connected to a port by a conduit. The balloon is positioned adjacent to the urethra and applies non-circumferential compression to the urethral wall. The effectiveness of the treatment depends on the proper positioning of the balloon at a target site within the patient's body, such as the retropubic space near the urethral-bladder junction, above the urogenital diaphragm adjacent to the urethral wall. If two balloons (e.g., two implantable devices) are used, their preferred positioning is usually symmetrical and lateral with respect to the urethra. Medical imaging techniques such as fluoroscopy or transrectal ultrasonography (TRUS) may be used to assist in the positioning of the balloon(s). As discussed in U.S. Patent Application No. 16 / 450246, filed on 24 June 2019 and assigned to UroMedica, Inc. (which is incorporated herein by reference in its entirety), sensors incorporated into implantable devices and / or one or more surgical tools may also be used to assist in the positioning of balloons.

[0009] During the implantation procedure, the implantable device(s) are placed inside the patient's body with the balloon(s) positioned and fixed in place at the target site(s). The balloon(s) are only slightly inflated, typically between 0.5 and 1.5 cc, over a period of 4 to 6 weeks to allow tissue encapsulation and stabilize the balloon(s) at their target site(s). In particular, without encapsulation, the implantable device(s) tend to move through the expansion pathway into which they are implanted. For optimal effect, it is important that the balloon(s) remain above the pelvic floor. Therefore, it is crucial that fixation occurs during this implantation procedure. After encapsulation, one or more modulochemical procedures can be performed on the patient to adjust the volume of fluid within the balloon(s) to achieve and maintain urinary suppression without causing undesirable obstruction.

[0010] The subject of this invention provides an implantable device for treating urinary incontinence, the implantable device having a helical fixation mechanism to prevent the balloon of the implantable device from undergoing undesirable displacement. Figures 1 to 9 show various embodiments of the implantable device, which can incorporate the helical fixation mechanism, and surgical tools used to place the implantable device in the patient's body. Various embodiments of the implantable device and surgical tools are shown in Figures 1 to 9 and are described below as examples, not as limitations. These examples, as well as additional examples of implantable devices and surgical tools, are discussed in U.S. Patents 5,964806, 6,045498, 6,419624, 6,579224, 8,926494, and 9,861384, all granted to UroMedica, Inc., and are incorporated herein by reference in their entirety. Figures 10 to 12 show examples of placement and adjustment of a pair of implantable devices for urethral junction in a patient after prostatectomy. Figures 13 to 19 illustrate the helical fixation mechanism incorporated into the implantable device and the process of placing the implantable device within the patient's tissue and securing the implantable medical device to the tissue.

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

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

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

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

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

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

[0017] Figure 4 shows the implantable device 110, according to an embodiment of the subject, after it has been placed in a desired location within the patient and expanded to displace body tissue toward the body lumen 432 in order to cause adjustable restraint of the body lumen 432. After the implantable device 110 has been placed in the patient (for example, using a method involving surgical tools as described below with reference to Figures 7-10) such that the contracted adjustable membrane element 112 is in a desired position adjacent to the body lumen 432, the body lumen 432 can be restrained to a desired degree by puncturing the septum 118 with the needle 121 of a syringe 120 and injecting a fluid material through the first lumen 115 into the adjustable membrane element 112. The physician can determine the desired degree of restraint of the body lumen 432 by means such as injecting fluid through the body lumen 432 and measuring back pressure. In one embodiment, the body lumen is the urethra, as will be further described below with reference to Figures 10-12.

[0018] After the implantable device 110 is properly positioned with the adjustable membrane element 112 positioned near the body lumen 432 and the septum 118 in the posterior port 116 positioned near the skin 430, a fluid material is injected into the device from a syringe 120. The adjustable membrane element 112 can be expanded to a certain extent and then contracted to a degree suitable for encapsulation of the adjustable membrane element 112 by body tissue.

[0019] This subject provides an implantable device 110 having adjustable postoperative membrane dilation. This adjustability is achieved because the septum 118 is located beneath and close to the patient's skin, for example, within the scrotum of a male patient or the labia of a female patient, although it is separated from the adjustable membrane element 112. The posterior port 116 and septum 118 are located, for example, by palpation of the skin area, and the needle 121 of a syringe 120 is inserted through the skin and septum 118 to add or remove fluid material to the adjustable membrane element 112, thereby increasing or decreasing the restraint of the body lumen 432.

[0020] Figure 5 is a longitudinal cross-sectional view of an implantable device 510 according to an embodiment of the subject. Figure 6 is a cross-sectional view of the implantable device 510 along line 6-6 in Figure 5. The implantable device 510 comprises an adjustable membrane element (also called a balloon) 512 and a long conduit 514, the conduit 514 comprising at least a first lumen 515 extending longitudinally within the conduit 514 from a first opening 515A at the rear end (also called the proximal end) of the conduit to a second opening 515B.

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

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

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

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

[0025] Figures 7–9 show a surgical toolkit for placing implantable devices, such as implantable devices 110 and 510, into patient tissue. The surgical toolkit includes a sheath 746 (shown in Figure 7) and a trocar 838 (shown in Figure 8). Figure 9 shows assembly 940, which includes the sheath 746 and the trocar 838.

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

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

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

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

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

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

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

[0033] In one embodiment, after the adjustable membrane element of the implantable device 1010 is partially inflated and the sheath 746 is completely removed from the patient, the pathway is passed through to the scrotum, the posterior port of the implantable device 1010 is grasped with forceps and positioned toward the upper end of the scrotum. The incision can be closed on the conduit of the implantable device 1010 by suturing or the like.

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

[0035] In one embodiment, if possible, the physician verifies the symmetrical positioning of the adjustable membrane elements of the implantable devices 1010A and 1010B relative to the urethra, for example, by using X-ray visualization or ultrasound. The push wire may be removed from the implantable devices 1010A and 1010B after the physician has determined that the positioning of both devices is appropriate.

[0036] Figure 12 is a diagram including a breakaway showing the adjustment of urethral junction after a pair of implantable devices 1010A and 1010B have been placed in a patient according to an embodiment of the subject. After they have been placed in the patient, the volume within the adjustable membrane elements of implantable devices 1010A and 1010B can be adjusted percutaneously, respectively, by piercing the skin and the septum of the posterior ports of implantable devices 1010A and 1010B with the needle of syringe 120. After placement at the target site, the adjustable membrane elements are each inflated to a volume of 0.5–1.5 cc and observed by X-ray or ultrasound to ensure they are in the correct position for urethral junction. Once this is confirmed, the adjustable membrane elements are left to their respective volumes of 0.5–1.5 cc, so that they remain firmly in place but are not distorted, for example, by scar tissue or anatomical abnormalities. The adjustable membrane elements are left in this state for 4–6 weeks to allow tissue encapsulation to fix their position. Next, the volume of each adjustable membrane element is adjusted to increase by 0.5–1.0 cc every 4–6 weeks until suppression is achieved. Over time, further adjustments may be needed to increase the volume of each adjustable membrane element to maintain suppression, or to decrease its volume to prevent urinary retention. In some cases, the physician will, if necessary, confirm that there is no urethral or bladder injury by cystoscopy.

[0037] While urethral junction in male patients after prostatectomy is shown as an example in Figures 10-12, this subject can be applied to urethral junction in any patient for urinary suppression in various embodiments (for example, in female patients or in male patients after transurethral resection of the prostate (TURP)). In various other embodiments, this subject can be applied to junction of any body lumen where necessary and feasible, taking into account factors including anatomical structure.

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

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

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

[0041] In various embodiments, the implantable device 1310 is a multi-lubricated (e.g., double-lubricated) implantable device that includes a push-wire lumen 1317 and an expansion lumen (not shown in Figure 13) as separate lumens.

[0042] The helical body 1350 is coupled to the conduit front end 1314B and functions as a fixation mechanism that limits the displacement of the implantable device 1310 within the tissue after implantation by securing the implantable device 1310 to the tissue. In various embodiments, the implantable device 1310 can be secured to the tissue by using rotational motion of the implantable device 1310 in a tightening direction (e.g., clockwise) to rotate and insert the helical body 1350 into a portion of the tissue. In some embodiments, the implantable device 1310 can be released from the tissue by using rotational motion of the implantable device 1310 in a loosening direction (e.g., counterclockwise) to disengage the helical body 1350 from a portion of the tissue when the implantable device 1310 needs to be repositioned within the tissue or removed from the tissue. This can be done, for example, by introducing a push wire 1324 to rotate the implantable device 1310 or by assisting such rotation. In various embodiments, the implantable device 1310 can also be released from tissue by pulling the implantable device 1310 to disengage the helical body 1350 from a portion of the tissue (a method called “pulling release”), and the helical body 1350 is configured to avoid unacceptable levels of tissue damage and / or device failure resulting from pulling. For example, the amount of tensile force required to pull the implantable device 1310 from the tissue at the target site while the helical body 1350 remains engaged with the tissue (called “pulling force”) must be small enough to prevent the implantable device 1310 from breaking and leaving a portion in the patient’s body. In one embodiment, the helical body 1350 is made of a bioabsorbable material to facilitate pulling release. After being placed in body tissue, the bioabsorbable material (also called a biodegradable material) decomposes over time into one or more non-toxic substances that can be safely absorbed by the patient’s body. The bioabsorbable helical body 1350 can fix the implantable device 1310 until it is stabilized by tissue encapsulation following the initial placement.Examples of bioabsorbable materials for the helical body 1350 include bioabsorbable polymers having mechanical properties (e.g., strength and rigidity) suitable for use in constructing helical bodies, such as chitosan (e.g., derived from natural chitin from crustaceans or mushrooms), as well as bioabsorbable metals such as manganese alloys, magnesium alloys, iron alloys, and / or zinc alloys.

[0043] The implantable device 1310 can be a combination of the helical body 1350 and an implantable device selected from those described with reference to Figures 1 to 12, including but not limited to implantable devices including implantable device 110, or implantable devices including various combinations of features of implantable devices 110, 510, and 1010.

[0044] The sheath 1346 has a long cylindrical sheath body 1345 and a channel 1344 extending longitudinally within the sheath body 1345. The sheath body 1345A has a rear end 1345A, a front end 1345B, and slots 1348B-C extending longitudinally along at least a portion of the sheath body 1345. In the illustrated embodiment, slots 1348B-C include a slot front 1348B and a slot middle 1348C. In other embodiments, the slot middle 1348C may extend to the sheath rear end 1345A or a point near the sheath rear end 1345A. The slot middle 1348C is sized to allow at least an adjustable membrane element 1312 (in its contracted state) and a conduit 1314 to be positioned within the channel 1344 of the sheath 1346. The slot front 1348B is sized to prevent the adjustable membrane element 1312 from exiting the channel 1344 when it is advanced within the channel 1344, and to allow the sheath 1346 to be separated from the implantable device 1310 (for example, by passing a portion of the elongated conduit 1314, which can be stretched to reduce its diameter if necessary, through the slot front 1348B), and subsequently removed from the tissue after the implantable device 1310 has been positioned and fixed in the tissue. This is to reduce the possibility of the edge of the slot front 1348B cutting into the expansion lumen within the conduit 1314. Another method (other than stretching the long conduit 1314) to protect the expansion lumen within the conduit 1314 from being cut by the edge of the slot front 1348B is to align the lumen inlet 1317A with the center of the slot front 1348B when passing a portion of the long conduit 1314 through the slot front 1348B. Yet another method to protect the expansion lumen within the conduit 1314 from being cut by the edge of the slot front 1348B is to pass a portion of the strain relief through the slot front 1348B, as will be further described below with reference to Figure 19. In various embodiments, the sheath 1346 may be a modified sheath 946 that includes a slot 1348 which is C-shaped over its diameter and has a varying width, and which includes a front portion and a middle portion that is wider than the front portion.

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

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

[0047] The push wire 1324 and conduit 1314 may optionally be configured to allow the push wire to be used to rotate or assist in the rotation of the implantable device 1310. In some embodiments, as shown in Figure 13, the pulse push wire front end 1326B is configured to include a driver 1327, and the conduit front end 1314B is configured to include a drive 1328 molded to fit into the driver 1327. For example, the driver 1327 may have a shape similar to the front end of a screwdriver, and the drive 1328 may have a screw head drive shape corresponding to the shape of a screwdriver (e.g., slotted, Phillips, square, hexagonal, or another standard or non-standard screwdrive shape). In other embodiments where the push wire 1324 is not intended to be used to rotate the implantable device 1310, the driver 1327 and drive 1328 are not required and may not be included.

[0048] In this specification, terms including “substantial,” “substantially,” “approximately,” and “nearly” may refer to imperfections or inaccuracies arising from practical factors, including accuracy in manual operation and errors within manufacturing tolerances. For example, the longitudinal axes of the push wire in a conduit and the longitudinal axis of the push wire lumen are not perfectly parallel due to, in particular, (1) errors within their manufacturing tolerances, (2) the manually controlled movement of the push wire within the push wire lumen, and (3) the absence of a portion of the push wire within the push wire lumen, so when the former (push wire) is partially positioned within the latter (push wire lumen), they may be “substantial.” Such terms (“substantial,” “substantially,” “approximately,” and “nearly” may also refer to small deviations due to design. For example, the push wire lumen may be “substantial” to the longitudinal axis of the conduit, but a small portion of the push wire lumen adjacent to the inlet (on the side of the conduit) deviates from being parallel to the longitudinal axis of the conduit by design. In a multi-lume implantable device, the pushwire lumen may be "substantially parallel" to the longitudinal axis of the conduit. The main portion of this pushwire lumen may be off-center within the conduit to allow space for the expansion lumen, but the anterior portion of the pushwire lumen may deviate from being parallel to the longitudinal axis of the conduit and terminate at the center of the anterior end of the conduit.

[0049] Figure 14 shows an implantable device kit 1420 according to an embodiment of the subject, including an implantable device 1410, a sheath 1346, and optionally a push wire 1324. The implantable device 1410, the sheath 1346, and optionally the push wire 1324 can be provided as a device kit 1420, and the kit may also include other accessories (e.g., surgical tools for inserting the sheath 1346 into tissue, such as one or more trocars for use with the sheath, as described above with reference to Figures 7-9). The implantable device 1410 can be used to join lumens in the body and may include an adjustable membrane element (also referred to as a balloon) 1412, a long conduit 1414, a posterior port 1416, and a fixation mechanism 1350. The adjustable membrane element 1412 is configured to join lumens and includes a continuous wall having an inner surface defining a chamber. The rear port 1416 includes a conical strain relief 1425 (for example, made from silicone or biostable segmented polyurethane) coupled to the port base 1423. The conduit 1414 has a rear conduit end 1414A coupled to the rear port 1416 in the strain relief 1425, a front conduit end 1414B coupled to an adjustable membrane element 1412, a sealed circumferential surface connected to the adjustable membrane element 1412 near the front conduit end 1414B, and an expansion lumen 1415 extending longitudinally within the conduit 1414. The expansion lumen 1415 has a nasoluminous

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

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

[0052] In another embodiment, a push wire 1324 can be used to move the implantable device 1310 at least partially through a channel 1344 of the sheath 1346. The implantable device 1410 may be a single-lube implantable device having an expansion lumen 1415 which also functions as a push wire lumen. The expansion lumen 1415 can satisfy the requirements of the push wire lumen 1317 as described above, with the push wire lumen inlet being the rear end 1415A of the expansion lumen. The push wire 1324 can enter the expansion lumen 1415 by perforating a partition 1418.

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

[0054] The push wire 1324 and conduit 1414 may optionally be configured to allow the push wire to be used to rotate or assist in the rotation of the implantable device 1410. In some embodiments, as shown in Figure 14, the pulse push wire front end 1326B is configured to include a driver 1327, and the conduit front end 1414B is configured to include a drive 1428 molded to fit into the driver 1327. For example, the driver 1327 may have a shape similar to the front end of a screwdriver, and the drive 1428 may have a screw head drive shape corresponding to the shape of the screwdriver (e.g., slotted, Phillips, square, hexagonal, or another standard or non-standard screwdrive shape). In other embodiments where the push wire 1324 is not intended to be used to rotate the implantable device 1310, the driver 1327 and drive 1428 are not required and may not be included.

[0055] The implantable device 1410 can be a combination of the helical body 1350 and an implantable device selected from the implantable devices described with reference to Figures 1 to 12, including but not limited to implantable devices including implantable device 510 or implantable devices including various combinations of features of implantable devices 110, 510, and 1010.

[0056] In various embodiments, the implantable devices 1310 and 1410 may have substantially similar sizes. For example, the adjustable membrane elements 1312 and 1412 may have substantially similar sizes, the elongated conduits 1314 and 1414 may have substantially similar sizes, and the rear ports 1316 and 1416 may have substantially similar sizes.

[0057] Figures 15–19 illustrate a method for placing an implantable device 1510 in patient tissue using a sheath 1346, according to an embodiment of the subject. The implantable device 1510 can be used to join lumens within the body and may include an adjustable membrane element (also referred to as a balloon) 1512, a long conduit 1514, a posterior port 1516, and a helical body 1350. Examples of implantable devices 1510 include implantable device 1310 (having an adjustable membrane element 1512, an elongated conduit 1514, a rear port 1516 corresponding to the adjustable membrane element 1312, an elongated conduit 1314, and a rear port 1316, respectively), and implantable device 1410 (having an adjustable membrane element 1512, an elongated conduit 1514, a rear port 1516 corresponding to the adjustable membrane element 1412, an elongated conduit 1414, and a rear port 1416, respectively). Embodiments shown in Figures 15 to 19 are described as examples, not limitations, to illustrate how implantable devices 1510 may be positioned in and fixed to tissue. For example, although a push wire is not used in the illustrated embodiment, a push wire can be used in various embodiments in which the implantable device 1510 is configured to accept a portion of the push wire in order to advance the implantable device 1510 within the sheath 1346 and / or the tissue channel 1344. During the execution of this method, the portion of the implantable device 1510 and the sheath 1346 that has entered the patient can be visualized using medical imaging techniques such as fluoroscopy or ultrasound.

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

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

[0060] Due to the high sensitivity of the volume of the adjustable membrane element 1512 to resist rotation (i.e., sliding) of the adjustable membrane element 1512 against the sheath due to the substantially limited protrusion through the front of the slot 1348B, the inflation of the adjustable membrane element 1512 at this point in the implementation of the method needs to be precisely controlled. In one embodiment, a small volume syringe, such as 1.0 cc, can be used for fine volume control when inflating the adjustable membrane element 1512. In another embodiment, the adjustable membrane element 1512 can be inflated to a specific pressure. This can be done, for example, using a pressure gauge on the syringe or a T-connector coupled between the syringe and the adjustable membrane element 1512. By controlling pressure rather than volume, the method can be performed using a single syringe to inflate the adjustable membrane element 1512, first for rotational stability and later for joining the body lumen. In various embodiments, this volume sensitivity can be reduced in a looser fit as needed, either by increasing the diameter of the sheath 1346 and / or decreasing the diameter (in its contracted state) of the adjustable membrane element 1512.

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

[0062] The adjustable membrane element 1512 is fixed to the front of the sheath to prevent the spiral body 1350 from rotating relative to the sheath 1346 while it extends into the tissue at the target site. The sheath 1346 is then rotated in a tightening direction to rotate and insert the spiral body 1350 into the tissue. The number of rotations required to provide the desired level of fixation can be determined using testing and experience on each of the different types of tissue to which the implantable device 1510 can be fixed (e.g., scar, muscle, or fat). The desired level of fixation can provide sufficient fixation to the implantable device 1510 to prevent the adjustable membrane element 1512 from moving until encapsulation occurs. In various embodiments, the desired level of fixation also allows for the removal of the implantable device 1510 by withdrawal release (without actively disengaging the spiral body 1350 from the tissue) without causing tissue damage and / or device failure.

[0063] Figure 17 shows that after the helical body 1350 is rotated and inserted into the tissue, the sheath 1346 is withdrawn to allow the adjustable membrane element 1512 to expand. The adjustable membrane element 1512 is deflated to allow the withdrawal of the sheath 1346 before it expands in the tissue.

[0064] Figure 18 shows the adjustable membrane element 1512 being inflated in the tissue site (e.g., to a volume of 2-3 cc). Proper positioning of the adjustable membrane element 1512 can be confirmed by observing the joint (e.g., flattening) of the body lumen (e.g., urethra) using fluoroscopy or endoscopy. When the position is adjusted, the adjustable membrane element 1512 is deflated, returned into the anterior part of the sheath, and inflated to re-secure the adjustable membrane element 1512 to the anterior part of the sheath, preventing it from rotating relative to the sheath 1346, and the helical body 1350 can be actively disengaged from the tissue by rotating the sheath 1346 in the loosening direction. The steps described above with reference to Figures 16-18 can be repeated until the positioning of the adjustable membrane element 1512 is satisfactory. Alternatively, the steps described above with reference to Figures 15-18 can be partially performed by skipping the rotation of the helical body 1350 until proper positioning of the adjustable membrane element 1512 is confirmed. Next, the adjustable membrane element 1512 is contracted, and the sheath 1346 is advanced so that the anterior portion of the sheath passes over the adjustable membrane element 1512, and the implantable device 1510 can be fixed to the tissue at the target site by performing the steps described above with reference to Figures 16-18.

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

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

[0067] Figures 20-21 show scenarios for performing the methods shown in Figures 15-19 according to embodiments of this subject, and device features associated with those scenarios. Figure 20 shows an adjustable membrane element 1512 of the implantable device 1510 protruding from a portion of the slot in the sheath 1346 (e.g., the slot front 1348B). Figure 21 is a longitudinal cross-sectional view of the adjustable membrane element 1512 from the slot front 1348B of the sheath 1346. As described above with reference to Figure 16, over-expansion of the adjustable membrane element 1512 may cause a portion of it to protrude from the sheath 1346 through the slot front 1348B, thereby exposing the adjustable membrane element 1512 to the risk of damage from the edge of the slot front 1348B. Such protrusions can be observed, for example, using fluorescence fluoroscopy. On the other hand, limited protrusion of the adjustable membrane element 1512 from the slot front 1348B can add rotational stability (i.e., sliding resistance) of the adjustable membrane element 1512 within the sheath 1346. In this case, special care should be taken to ensure that the edges of the slot are smooth and rounded. In various embodiments, as shown in Figure 21, the slot front 1348B has two slot edges, each slot edge including a rounded inner edge 1349 with an inner radius (directly coupled to the inner surface of the sheath 1346) and a rounded outer edge 1350 with an outer radius (directly coupled to the outer surface of the sheath 1346). The inner and outer radii can be determined experimentally to prevent damage to the adjustable membrane element 1512 caused by its protrusion from the sheath 1346 through the slot front 1348B, with the inner radius being greater than the outer radius. In various embodiments, the entire slot 1348 may have such inner and outer edges. Furthermore, the edges of the slot 1348 or the entire elongated cylindrical sheath body 1345 can be treated with a lubricating coating such as parylene to further prevent damage to the adjustable membrane element 1512.

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

[0069] Several non-limiting embodiments of this subject (Examples 1-21) are provided below. Example 1 provides an implantable device configured to be positioned within the tissue of a living organism for joining body lumens. The implantable device may include an adjustable membrane element, a long conduit, a rear port, and a spiral body. The adjustable membrane element may include a continuous wall having an inner surface defining a chamber and configured to join body lumens. The long conduit may include a conduit circumferential surface, a conduit rear end, a conduit front end, and one or more conduit lumens. The conduit circumferential surface may be connected to and sealed by the adjustable membrane element at or near the conduit front end. One or more conduit lumens may include at least an expansion lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end. The rear port may be connected to the long conduit at the conduit rear end and may include a cavity in fluid communication with the first opening of the expansion lumen. The spiral may be connected to the front end of the conduit, and the implantable device may be configured to be secured to the tissue by rotating the entire implantable device in a tightening direction.

[0070] In Example 2, the subject of Example 1 may optionally be configured such that the rear port includes a strain relief and a port base coupled to the strain relief, and is connected to a long conduit with the rear end of the conduit located within the strain relief.

[0071] In Example 3, the subject matter of either one or any combination of Examples 1 and 2 may optionally be configured such that the implantable device includes one or more elastic portions, each constructed of biostable segmented polyurethane.

[0072] In Example 4, the subject of any one or any combination of Examples 1 to 3 may be optionally configured such that the helical body is constructed from a bioabsorbable material. Example 5 provides an implantable device kit for controllable joining of a body lumen in tissue at a target site in vivo. The implantable device kit may include an implantable device and a sheath. The implantable device may include an adjustable membrane element, a long conduit, a rear port, and a helical body. The adjustable membrane element may include a continuous wall having an inner surface that joins the body lumen and defines a chamber. The long conduit may include a conduit circumferential surface, a conduit rear end, a conduit front end, and one or more conduit lumens. The conduit circumferential surface may be connected to and sealed by an adjustable membrane element at or near the conduit front end. One or more conduit lumens may include an expansion lumen having a first opening at the conduit rear end, a second opening that is in fluid communication with the chamber, and a closed end at or near the conduit front end. The rear port may include a cavity connected to the conduit rear end and in fluid communication with the first opening of the expansion lumen. The spiral body may be connected to the leading end of the conduit and configured to secure the implantable device to the tissue. The sheath may house a portion of the implantable device, including an adjustable membrane element, and be used to guide the implantable device to the target site and to rotate the implantable device when the portion of the implantable device is positioned within the sheath with the adjustable membrane element partially inflated.

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

[0074] In Example 7, the subject matter of any one or any combination of Examples 5 and 6 may optionally be configured such that the sheath includes a long body and a longitudinal slot. The long body includes a rear sheath, a front sheath, and a middle sheath coupled between the rear and front sheaths. The longitudinal slot includes at least a middle slot extending over the middle sheath and a front slot extending over the front sheath. The middle slot is configured to allow the placement of a portion of the implantable device within the sheath. The front slot is configured to allow the implantable device to rotate with the sheath when an adjustable membrane element is substantially positioned within the sheath and partially inflated, thereby allowing the sheath to be separated from the implantable device.

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

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

[0077] In Example 11, the subject of any one or any combination of Examples 7 to 10 may optionally be configured such that the sheath includes an inner surface and an outer surface, and the longitudinal slot is formed by two slot edges bonded between the inner surface and the outer surface, each of which includes an inner edge directly bonded to the inner surface and having an inner radius, and an outer edge directly bonded to the outer surface and having an outer radius, and at least for the front of the slot, the inner radius is greater than the outer radius.

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

[0079] Example 13 provides a method for joining body lumens in tissue at a target site in vivo. The method may include providing an implantable device. The implantable device may include an adjustable membrane element, a long conduit, a rear port, and a helical body. The adjustable membrane element may be configured to join body lumens and may include a continuous wall having an inner surface defining a chamber. The long conduit may include a conduit circumferential surface, a conduit rear end, a conduit front end, and one or more conduit lumens. The conduit circumferential surface may be connected to and sealed by an adjustable membrane element at or near the conduit front end. One or more conduit lumens may include an expansion lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end. The rear port may include a cavity connected to the conduit rear end and in fluid communication with the first opening of the expansion lumen. The helical body may be coupled to the conduit front end. The method may further include, after positioning the implantable device at the target site, rotating the implantable device in a tightening direction to rotate and insert the helical body into the tissue.

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

[0081] In Example 16, the subject matter of any one or any combination of Examples 13-15 may optionally further include providing a sheath and positioning a portion of an implantable device, including an adjustable membrane element, within the sheath such that the helical body extends from the front end of the sheath, thereby rotating the implantable device, which includes partially inflating the adjustable membrane element so that the implantable device rotates with the sheath, and rotating the sheath.

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

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

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

[0085] In Example 20, the subject of partially inflating a membrane element that can be adjusted so that the implantable device rotates with the sheath, as seen in any one or any combination of Examples 16-18, may optionally include injecting fluid into a cavity at the rear port of the implantable device and controlling the pressure of the fluid injected into the cavity.

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

[0087] This application is intended to encompass adaptations or variations of the subject matter. It should be understood that the above detailed description is illustrative and not limiting. Other embodiments will be apparent to those skilled in the art upon reading and understanding the above description. The scope of the subject matter should be determined with reference to the appended claims, along with the entire scope of legal equivalents to which such claims are granted.

Claims

1. An implantable device configured to be positioned within the tissue of a living organism for joining the body tubular lumens of the living organism, wherein the implantable device is An adjustable membrane element comprising a continuous wall having an inner surface defining a chamber, configured to join the body lumen, A long conduit comprising a conduit circumferential surface, a conduit rear end, a conduit front end, and one or more conduit lumens, wherein the conduit circumferential surface is connected to and sealed by the adjustable membrane element at or near the conduit front end, and the one or more conduit lumens each include at least an expansion lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end, A rear port, which includes a cavity connected to the long conduit at the rear end of the conduit and in fluid communication with the first opening of the expansion tube lumen, An implantable device comprising: a spiral body connected to the front end of the conduit, which is rotated into the tissue by rotating the entire implantable device in a tightening direction, thereby fixing the implantable device to the tissue.

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

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

4. The implantable device according to claim 1 or 2, wherein the helical body is constructed from a bioabsorbable material.

5. An implantable device kit for controllable joining of body lumens in tissue at a target site within a living organism, An implantable device, An adjustable membrane element comprising a continuous wall having an inner surface defining a chamber, configured to join the body lumen, A long conduit comprising a conduit circumferential surface, a conduit rear end, a conduit front end, and one or more conduit lumens, wherein the conduit circumferential surface is connected to and sealed by the adjustable membrane element at or near the conduit front end, and the one or more conduit lumens include an expansion lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber, and a closed end at or near the conduit front end, A rear port, which includes a cavity connected to the rear end of the conduit and in fluid communication with the first opening of the expansion tube lumen, An implantable device comprising: a spiral body connected to the front end of the conduit, which is rotated into the tissue by rotating the entire implantable device in a tightening direction, thereby fixing the implantable device to the tissue; An implantable device kit comprising: a sheath configured to house a portion of the implantable device including the adjustable membrane element, the sheath configured to guide the implantable device to the target site, and configured to be used to rotate the implantable device when the portion of the implantable device is positioned within the sheath with the adjustable membrane element partially expanded.

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

7. The aforementioned sheath is A long body including a rear sheath, a front sheath, and an intermediate sheath connected between the rear and front sheaths, An implantable device kit according to claim 5 or 6, comprising a longitudinal slot including at least a slot intermediate portion extending over the sheath intermediate portion and a slot front portion extending over the sheath front portion, wherein the slot intermediate portion is configured to allow placement of a portion of an implantable device within the sheath, and the slot front portion is configured to allow rotation of the implantable device with the sheath when the adjustable membrane element is substantially positioned within the sheath and partially inflated, and to allow separation of the sheath from the implantable device.

8. The implantable device kit according to claim 7, wherein the front part of the sheath has an inner surface including one or more gripping mechanisms.

9. The implantable device kit according to claim 8, wherein one or more gripping mechanisms are provided with longitudinal grooves or protrusions.

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

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

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

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