WO2019058180A2

WO2019058180A2 - Readjustable and reversible tensioning means for urinary incontinence

Info

Publication number: WO2019058180A2
Application number: PCT/IB2018/001225
Authority: WO
Inventors: Marian Devonec
Original assignee: Marian Devonec
Priority date: 2017-09-25
Filing date: 2018-09-25
Publication date: 2019-03-28
Also published as: WO2019058180A3

Abstract

An implantable medical device for the treatment of urinary incontinence having a tensioning means including a body having a proximate end, a distal end, a top side, a bottom side, a first opening, and a second opening, a mobile member located within the body and movable along a longitudinal axis, a balloon positioned between the mobile member and the proximate end of the body, a channel located within the mobile member, and at least one thread entering through the first opening, extending through the channel and exiting through the second opening.

Description

READJUSTABLE AND REVERSIBLE TENSIONING MEANS FOR URINARY

INCONTINENCE

BACKGROUND

Urinary incontinence is an involuntary leakage of urine that occurs when control over the urinary sphincter is either lost or weakened. There are many types of incontinence with the most common being stress incontinence. This involves urine leakage when pressure is exerted on the bladder by activities such as coughing, sneezing, laughing, exercising, and heavy lifting. In females, stress incontinence can be caused by a variety of factors including weakened muscles associated with child birth, menopause, and muscle tone relaxing with age, resulting in pelvic floor and urethra hypermobility. While stress incontinence is more common in women, men may also be affected. Therefore, it is important for solutions to be applicable to both the male and female anatomy. In males, prostate cancer surgery is the main cause of stress incontinence, often causing direct injury or indirect nerve damage of the sphincter muscle.

A healthy human body stores urine in the bladder, which is located within the lower abdominal region known as the pelvis. The bladder connects to the urethra, a tube through which urine leaves the body. During urination, the sphincter muscle surrounding the urethra relaxes and allows urine to pass. In a body suffering from urinary incontinence, the sphincter muscle may be consistently in a relaxed or weakened state. This causes urine to pass involuntarily through the urethra, resulting in leakage and/or frequent u rination, among other issues. Sphincter deficiency is often minute and requires a small adjustment to correct. Sphincter deficiency may also require multiple adjustments over a period of time.

There are several current treatments for stress u rinary incontinence in females. A common treatment involves the use of tapes such as tension free vaginal tape (TVT), trans-obturator tape (TOT), or mini tapes to support and maintain the ureth ra in a stable position. These tapes are placed under the urethra like a sling or hammock to retain and stabilize the urethra in its natural position. However, these procedures often incur groin pain, infection, urethra erosion, and/or vaginal erosion over time. Dysuria or persisting incontinence may also occur and often requires re-operation and, in some cases, surgical removal of the tape altogether. Among available devices, the Remeex device (Neomedic international) consists publication 2008/0021263 A!) . This re-adjustable device is the combination of a woven tape suspended by threads anchored to a tensioning and rotating device consisting in a drum or spool positioned in the supra-pubic area. Tension re-adjustment with this device necessitates re-operation to free the device from surrounding tissue colonization, Electro cautery dissection of fibrotic tissue surrounding the device is mandatory. Then, tension readjustment Is made with the use of a screwdriver on 8 patient under anesthesia. Adjustment Is realized under conditions different far from natural conditions,

Wijay (US patent US 8,211,004} has Improved the design of the original emeex device. The drum is protected and sea!ed inside a housing with a hermetic seai. This prevents from colonization of the device by surrounding scar tissue. The sling does not comprise a tape. The sling is a hollow tube with a thread inside. The two extremities of the thread are rotated around the drum. Rotation of the drum around its axis allows more tension or less tension according to the clockwise or anticlockwise rotation of a screw. A screw-driver is needed to rotate the screw.

Another current treatment for stress urinary incontinence is Burch colposuspension. This surgical technique involves suspension of the vagina by threads positioned laterally on either side of the urethra, resulting in the urethra suspended indirectly by a natural vaginal hammock. The Burch technique does not induce groin pain and results in less urethra or vaginal erosion compared to the use of tapes as described above. However, over time, the threads often cut progressively into the vaginal wall, causing the natural hammock to lose its th read support. This results in a recurrence of incontinence and the need for reoperation .

In men, similar techniques may be used to treat incontinence caused by surgical procedures, such as radical prostatectomy. An example of a common technique involves the use of a tape, such as a transobturator tape, to support and maintain the urethra, pelvic floor fascia, and vesico-urethral anastomosis in a stable position. However, groin pain, infection, urethra erosion, and insufficient correction are common during such procedures.

If incontinence persists after an original operation, such as due to aging, further muscle relaxation, or other diseases or disorders, one or more adjustments to reposition the urethra may be necessary. Therefore, minimally invasive techniques for adjusting the position of the urethra without reoperation would be beneficial. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A-D are front views of a suspension means, consistent with various aspects of the present disclosure.

FIG. 2A is a cross-sectional view of an example of an implantable medical device before initial tensioning, consistent with various aspects of the present disclosure.

FIG. 2B is a cross-sectional view of the implantable medical device of FIG. 2A after initial tensioning, consistent with various aspects of the present disclosure.

Fig. 2C is a cross-sectional view of the implantable medical device of FIG. 2B after an optional first adjustment, consistent with various aspects of the present disclosure.

FIG. 2D is a cross-sectional view of the implantable medical device of FIG. 2C after an optional second adjustment, consistent with various aspects of the present disclosure.

FIGS. 2A'-D' show an example route of the suspension means through the implantable medical device of FIGS. 2A-D, consistent with various aspects of the present disclosure.

FIG. 3A shows a first step of an example method of using the implantable medical device, consistent with various aspects of the present disclosure.

FIG. 3B shows a second step of the method of using the implantable medical device of FIG. 3A, consistent with various aspects of the present disclosure.

FIG. 3C shows an optional third step of the method of using the implantable medical device of FIG. 3B, consistent with va rious aspects of the present disclosure.

FIG. 3D shows an optional fourth step of the method of using the implantable medical device of FIG. 3C, consistent with various aspects of the present disclosure.

FIG. 4A is a perspective view of another example of an implantable medical device, consistent with various aspects of the present disclosure.

FIG. 4B is a cross-sectional side view of the implantable medical device of FIG. 4A, consistent with various aspects of the present disclosure.

FIG.4C is a cross-sectional front view of the implantable medical device of FIG. 4B, consistent with various aspects of the present disclosure. FIG. 4D is a cross-sectional side view of the implantable medical device of FIG. 4A, consistent with various aspects of the present disclosure.

FIG.4E is a cross-sectional front view of the implantable medical device of FIG. 4D, consistent with various aspects of the present disclosure.

FIG. 5A is a schematic representation of another example of the implantable medical device of FIG. 4A before initial tensioning, consistent with various aspects of the present disclosure.

FIG. 5B is a schematic representation of the implantable medical device of FIG. 4A after initial tensioning, consistent with various aspects of the present disclosure.

FIG. 5C is a schematic representation of the implantable medical device of FIG.

4A after an optional first adjustment, consistent with various aspects of the present disclosure.

FIG. 5D is a schematic representation of the implantable medical device of FIG. 4A after an optional second adjustment, consistent with various aspects of the present disclosure.

FIGS. 5A'-D' show a route of the suspension means through the implantable medical device of FIGS. 5A-D, consistent with various aspects of the present disclosure.

FIG. 6A is a perspective view of another example implantable medical device before initial tensioning, consistent with various aspects of the present disclosure.

FIG. 6B is a perspective view of the implantable medical device of FIG. 6A after initial tensioning, consistent with various aspects of the present disclosu re.

FIG. 6C is a perspective view of the implantable medical device of FIG. 6B after an optional first adjustment, consistent with various aspects of the present disclosu re.

FIG. 6A' is a perspective view of another example implantable medical device before initial tensioning, consistent with various aspects of the present disclosure.

FIG. 6B' is a perspective view of the implantable medical device of FIG. 6A' after initial tensioning, consistent with various aspects of the present disclosure.

FIG. 6C is a perspective view of the implantable medical device of FIG. 6B' after an optional first adjustment, consistent with various aspects of the present disclosure. While the invention is amenable to various modifications and alternative forms, specific aspects have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular aspects described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

DESCRIPTION

Various aspects of the present disclosu re are directed toward implantable medical devices for the treatment of stress urinary incontinence in accordance with various aspects disclosed. In certain instances, an implantable medical device for the treatment of female or male stress urinary incontinence consists of a tensioning means and a suspension means. According to aspects of the present disclosure, the suspension means is a device capable of suspending a patient's urethra in an elevated position. The tensioning means allows for adjustment of the suspension means within the patient's body.

FIGS. 1A-1D are front views of a suspension means 20, consistent with various aspects of the present disclosure. The suspension means 20 may include a pair of threads 21 having a first end and a second end. The first end includes at least one suspension member 22 at a first extremity 21b of each of the pair of threads 21. The second end at a second extremity 21a of each of the pair of threads 1 is free. In certain instances, the pair of threads 21 is formed from a non-biodegradable material with a monofilament structure. In other instances, the pair of threads 21 may be poly-propylene threads, polyvinylidene difluoride (PVDF) threads, or biologically compatible metallic threads.

As shown in FIGS. 1A-1C, the suspension member 22 may include, for example, a bead 22a, a solid washer 22b, or a clip 22c arranged with the pair of threads 21. As shown in FIG. ID, to prevent migration of the suspension member 22 through tissue, a soft woven perforated washer 25 may be used in conjunction with bead 22a, solid washer 22b or clip 22c The diameter of the suspension member 22 is at least about 5 mm (although other sizes may be used). In certain instances, the suspension member 22 is made of a nonbiodegradable and biologically compatible material. For example, the suspension member 22 may be a biologically compatible metal such as gold, silver, or titanium. The suspension member 22 may also be glass or a biologically compatible plastic material. FIG. 2A is a cross-sectional view of an example of an implantable medical device before initial tensioning, consistent with various aspects of the present disclosure. In certain instances, the tensioning means 30 includes a body comprising an outer cylinder 31 with a mobile member 33. The mobile member 33 includes an inner cylinder 32. The inner cylinder 32 is capable of moving along a longitudinal central axis within the outer cylinder 31. The inner cylinder 32 has a smaller diameter and height than the outer cylinder 31. This allows for ease of movement of the inner cylinder 32 within outer cylinder 31. The outer cylinder 31 has a base 31a, a summit 31b, a top side 31f, and a bottom side 31g. The summit 31b is closed by a membrane 31c. In certain instances, the membrane 31c is porous to liquid but does not allow the passage of cells. A chamber 38 is located within the outer cylinder 31 and between the top 32c of inner cylinder 32 and membrane 31c of outer cylinder 31. After implantation in vivo, the chamber 38 is filled with interstitial liquid 8. A movable member 35 may be located within outer cylinder 31 and between the base 31a of outer cylinder 31 and the bottom 32a of inner cylinder 32. The movable member 35 may be in liquid connection with a subcutaneous port 37 coupled to a free end of a tubular member36. In some embodiments, the movable member 35 is a balloon capable of expanding upon inflation with a fluid. In certain instances, the inner cylinder 32 is perforated by a straight vertical channel 34 positioned perpendicular to the longitudinal central axis. The outer cylinder 31 has two diametrically opposed openings. The first opening 31d is located on the bottom side 31g of outer cylinder 31 and the second opening 31e is located on the top side 31f of outer cylinder 31. Both openings are in alignment with the straight vertical channel 34 of inner cylinder 32.

FIG. 2A' shows an example route of the pair of threads 21 through the tensioning means before initial tensioning.

A second extremity 21a of each of the pair of threads 21 may be locked in a tense position as shown in FIG. 2B by a clip 24 permitting the creation of an in situ natural hammock of the pelvic floor fascia and vaginal wall below the urethra. The clip 24 may be, for example, spherical or elongate in shape. The clip may also be a bead, a knot, or any other mechanism capable of locking the second extremity 21a of each of the pair of threads 21 in place and preventing downward movement of the pair of threads 21 through the tensioning means 30. FIG. 2B' shows an example route of the pair of threads 21 after initial tensioning.

After time, the tensioning means 30 may require additional adjustment due to further relaxation of muscles or persistent incontinence due to other factors. Therefore, suspension means 20 may require an optional adjustment as shown in FIG. 2C. To adjust the suspension means 20, a liquid may be introduced into the subcutaneous port 37 and move through the tubular member 36 to the movable member 35, resulting in inflation of the movable member 35. Inflation of the movable member 35 forces the inner cylinder 32 toward the summit 31b of the outer cylinder 31. As this occurs, the interstitial liquid in chamber 38 moves out of chamber 38 through the pores of membrane 31c. The position of the inner cylinder 32 is determined by the degree of inflation of the movable member 35. As shown in FIG. 2C, the inner cylinder 32 moves toward the summit 31b in a direction denoted by the arrow by a distance (dT). Movement of the inner cylinder 32 translates to tensioning of the pair of threads 21 by a distance (D) denoted by the equation below:

D+dT*2

This results in an elevation of the suspension member 22 by the distance D and subsequent elevation of the patient's urethra by distance D.

FIG. 2C shows an example route of the pair of threads 21 after an optional first adjustment.

Any number of additional adjustments may be made to the tensioning means

30 as required by the patient. For example, tension in the pair of threads 21 can be decreased by an aspiration of liquid from subcutaneous port 37 as shown in FIG. 2D. The inner cylinder 32 moves toward the base 31a in a direction denoted by the arrow by a distance dR. As tension is decreased, the pair of threads 21 moves backwards through the first opening 31d of outer cylinder 31 by a distance (d) denoted by the equation below:

d= dR *2.

FIG. 2D' shows an example route of the pair of threads 21 after a second optional adjustment of the tensioning means 30. FIGS. 3A-3D show a schematic representation of a method of using an implantable medical device according to various aspects of the present disclosure. In a first step characterized by FIG. 3A, a first incision 4a is made in a supra-pubic area 4 of the patient. The first incision 4a may be at least about 20 mm in length. However, depending on the anatomy of the patient, the first incision 4a may be greater than 20 mm in length. In instances where the patient is a woman, a second incision la is made at a level of the vaginal wall 1 and just below the urethra 2. The second incision la may be at least about 15 mm in length. However, as disclosed above, the second incision la may be greater than 15 mm in length.

A pair of threads 21 with suspension member 22 is inserted through the second incision la and guided upwards through the patient's retro-pubic space 7 to the first incision 4a in the supra-pubic area 4. Each thread within the pair of threads 21 is positioned on either side of the urethra 2. The suspension member 22 of each thread is then fixed in place within the tissue (such as the vaginal wall 1 in a female patient) such that, when elevated, a pelvic floor fascia 3 forms an in situ natural hammock lb supporting the urethra 2. In a second step characterized by FIG. 3B, the pair of threads 21 are tensioned until the suspension member 22 contacts the pelvic floor fascia 3 of the pelvic floor. This tensioning of the pair of threads 21 creates the in situ natural hammock lb by elevating the pelvic floor fascia 3 to support and stabilize the u rethra 2 in a normal or natural position. After tensioning, the pair of threads 21 is fixed in position by a clip 24 at the second opening 31e. Any extra thread extending beyond the clip 24 may be cut and discarded. The subcutaneous port 37 is then positioned below the skin laterally to the first incision 4a in the supra-pubic area 4. The first incision 4a and second incision la are then closed.

In certain instances, a Foley catheter is systematically inserted in the bladder after spinal anesthesia to prevent urine retention due to pertaining bladder anesthesia. After removal of the Foley catheter, flowmetry and post void residual volume measurement with supra-pubic sonography are performed. Discharge of the patient is authorized after recording of at least two voids with satisfactory peak flow and acceptable residual volume and comparison of the post-operative data to respective pre-operative data. The first control is performed at one week and further at one month or later. In a third step characterized by FIG. 3C, the tensioning means 30 may be optionally adjusted to incrementally increase tension in the pair of threads 21 and subsequently elevate the urethra 2. Millimetric adjustments to the tension may be made by injection of a fluid into the subcutaneous port 37.

Alternatively, the tensioning means 30 may be optionally adjusted to incrementally decrease tension in the pair of threads 21 as shown in FIG. 3D. This may be done to lower the urethra 2 to a more suitable position according to the patient's needs. Tension in the pair of threads 21 is released by removing fluid from the tensioning means 30 by way of the subcutaneous port 37. Removal of fluid may be done, for example, by aspiration of fluid through the subcutaneous port 37 with a needle and syringe.

FIG. 4A is a side view of another example implantable medical device, consistent with various aspects of the present disclosure. As shown in FIG. 4A, the tensioning means 30 is a cylinder 41. The cylinder 41 has a first opening 31d and a second opening 31e with diametrically opposed positions. Additionally, the cylinder 41 has a base 41a and a summit 41b. Each of the base 41a and the summit 41b has a central orifice, 43a (not shown) and 43b, respectively, to hold and drive a needle 50 along a longitudinal central axis 60c. The needle 50 has a proximate end 50a extending from the base 41a and a distal end 50b extending from the summit 41b. In certain instances, the distal end 50b of needle 50 includes an at least one tooth 51. In other instances, the distal end 50b includes multiple teeth extending from the distal end 50b to approximately halfway between the distal end 50b and the proximate end 50a of needle 50.

FIG.4B is a schematic representation of a side view of the implantable medical device shown in FIG. 4A. The central orifice 43a located at the base 41a of cylinder 41 is smooth such that the needle 50 can glide through without resistance. The needle 50 is positioned in the center of the cylinder 41 and glides along the longitudinal central axis 60c of cylinder 41. The needle 50 has a male rack bar 51 with teeth 52 along its longitudinal central axis. In certain instances, the male rack bar 51 may extend approximately half the length of needle 50. In other instances, the male rack bar 51 may extend over half the length of needle 50. The length of the needle 50 may be at least two times the height of the cylinder 41. A pair of threads 21 extends through the first opening 31d and through an orifice 53 in needle 50 and exits through the second opening 31e. In certain instances, the central orifice 53 is aligned with the first opening 31d and second opening 31e. In other instances, the central orifice 53 may be moved toward the base 41a or summit 41b of cylinder 41.

FIG. 4C is a close up view of the summit 41b shown in FIG. 4B. The orifice 43 located at the summit 41b has flexible blades 43b which lock the distal end 50b of needle 50 with an at least one tooth 52 (not shown) in a fixed position.

FIG. 4D is a schematic representation of a side view the implantable medical device shown in FIGS. 4A-C. The cylinder 41 may have a thick wall (as shown by the shaded portion of FIG. 4D) and a female rack bar 51a with at least one groove along the longitudinal central axis 60c. The female rack bar 51a cooperates with an at least one tooth 52, such that when the at least one tooth 52 fits within a groove of the rack bar 51a, the needle 50 no longer moves through the cylinder 41. The needle 50 has a central orifice 53 through which the pair of threads 21 is threaded as disclosed above.

FIG. 4E is a close up view of the summit 41b of cylinder 41 shown in FIG. 4D. The needle 50 with an at least one tooth 52 (not shown) extends through the cylinder 41 along the longitudinal central axis. The orifice 43 located at the summit 41b of cylinder 41 is smooth such that the needle 50 with at least one tooth 52 can move through orifice 43 without resistance.

FIG. 5A is a schematic representation of another implantable medical device, consistent with various aspects of the present disclosure. The pair of threads 21 extends through the first opening 31d, the central orifice 53 of needle 50, and the second opening 31e of cylinder 41.

FIG. 5A' shows an example route of the pair of threads 21 through the tensioning means 30.

FIG. 5B shows the pair of threads 21 shown in FIG. 5A. The pair of threads 21 is tensioned appropriately such that the patient's urethra is suspended at an appropriate height. The pair of threads 21 are then locked in this tense position with a clip 24 positioned at the second opening 31e of cylinder 41.

FIG. 5B' shows an example tensioned route of the pair of threads 21 through the tensioning means 30.

FIG. 5C shows a first optional adjustment of the tensioning means 30, consistent with various aspects of the present disclosure. Percutaneous mobilization of the needle 50 by finger pressure on either the proximate end 50a or the distal end 50b allows for adjustment of the pair of threads 21. The adjustment may consist either of increasing or decreasing tension in the pair of threads 21 according to the direction of mobilization. This increase or decrease in tension translates to a lifting or lowering of the vaginal wall and, subsequently, a lifting or lowering of the urethra. The pair of threads 21 is tensioned by pushing proximate end 50a of the needle 50 a distance dT in a direction denoted by the arrow in FIG. 5C. The suspension member 22 and pelvic floor fascia 3 against which the suspension member 22 is located, lifts the pelvic floor fascia 3 to a height equal to two times the distance dT. The new tension is fixed by the flexible blades 43b and teeth 52 at the summit 41b of cylinder 41 (not shown in figure 5C).

FIG. 5C shows the route of the pair of threads 21 after a first optional adjustment of tensioning means 30.

FIG. 5D shows a second optional adjustment, consistent with various aspects of the present disclosure. If necessary, tension can be relieved by pushing distal end 50b of the needle 50 a distance dR in a direction denoted by the arrow in FIG. 5D. During the second optional adjustment, the distance covered by the pair of threads 21 is two times the distance dR.

FIG. 5D' shows an example route of the pair of threads 21 after a second optional adjustment of tensioning means 30.

FIG. 6A is a schematic representation of an example implantable medical device after implantation and before initial adjustment, consistent with various aspects of the present disclosure. A cylinder 60 is covered by an expandable wall 62a of a balloon 62. The wall 62a of external balloon 62 is attached to the cylinder 60 at a base 60a and a summit 60b. The wall 62a may be attached in a variety of ways sufficient to create a tight seal against cylinder 60. For example, the wall 62a may be glued to the base 60a and summit 60b of cylinder 60. The cylinder 60 houses a tubular member 36, which is coupled to a subcutaneous port 37 positioned in subcutaneous tissue of a supra-pubic area of the patient. The tubular member 36 extends along the longitudinal central axis 60c of cylinder 60.

An extensible channel 63 is located inside the wall 62a of the external balloon

62. The extensible channel 63 is positioned vertically in a plane perpendicular to the longitudinal central axis 60c. In some instances, the extensible channel may be approximately midway between the base 60a and summit 60b. The extensible channel 63 forms a circle around cylinder 60 having a diameter approximately equivalent to or slightly greater than the diameter of cylinder 60.

The extensible channel 63 has two openings with diametrically opposed positions, a first opening 31d and a second opening 31e. Thus, there are two extensible hemi-channels with substantially the same length, radius, and shape. Both extensible hemi- channels 64 are located in a plane perpendicular to the longitudinal central axis 60c of cylinder 60. The pair of threads 21 extends through the first opening 31d. Each thread may extend through a separate extensible hemi-channel such that the threads meet near the second opening 31e. The pair of threads 21 then exits through the second opening 31e.

FIG. 6A' is a longitudinal section of the tensioning means 30 shown in FIG. 6A. Tubular member 36 runs inside cylinder 60 and opens inside external balloon 62 through a small orifice 36a. Threads 21 enter extensible channel 63 through first opening 31d. Each thread 21 glides inside one hemi-channel 64 and exits through second opening 31e, before initial adjustment threads are loose.

FIG. 6B is a schematic representation of the implantable medical device shown in FIG. 6A after initial tensioning of the pair of threads 21. The pair of threads 21 is tensioned appropriately such that the patient's pelvic floor fascia 3 and, subsequently, urethra 2 is lifted and positioned appropriately. The pair of threads 21 is then fixed in place by a clip 24 to prevent movement of the pair of threads 21 th rough second opening 31e.

FIG. 6B' is a longitudinal section of tensioning means 30. Threads 21 enter extensible channel 63 through first opening 31d and each thread 21 glides through one of the two hemi-channels 64. Threads 21 are locked in tense position by a spherical or elongated clip 24 against the second opening 31e of extensible channel 63. Beyond clip 24, any extra length of threads 21 may be cut and discarded. External balloon 62 remains deflated.

FIG. 6C shows an optional first adjustment to the implantable medical device shown in FIGs. 6A-B. The external balloon 62 can be inflated with liquid introduced through the tubular member 36 by way of injection into subcutaneous port 37. When inflated to its maximum, the wall 62a of external balloon 62 may form a sphere. However, the external balloon 62 may be inflated any amount to correspond to an appropriate elevation of the urethra 2. The diameter of the external balloon 62 is equal to the height of cylinder 60. Since the pair of threads 21 have a fixed length and are fixed against the second opening 31e, inflation of the external balloon 62 results in the movement of the pair of threads 21 through first opening 31d and hemi-channels 64. This results in the elevation of the suspension member 22 and subsequent elevation of the pelvic floor fascia 3, vaginal wall 1, and urethra 2 (not shown in FIGs. 6A-C). The distance covered by the pair of th reads 21 corresponds to the hemi-circumference of inflated external balloon 62. For example, when the external balloon 62 is inflated to its maximum, the distance (D) by which the suspension member 22 and vaginal wall elevates is shown in the equation below:

dl is the diameter of the deflated external balloon 62. d2 is the diameter of the inflated external balloon 62 with a spherical shape.

FIG. 6C is a longitudinal section of tensioning means 30 shown in FIG. 6C. Threads 21 glided inside first opening 31d of extensible channel 63. The distance covered by threads 21 is approximately equal to the distance (D) by which the vaginal wall elevates as denoted by (d2-dl) x 3.14 / 2. The vaginal wall 1 (not shown in the figure) elevates by the same distance.

In men, access to the vesico-urethral anastomosis through the retro-pubic space is not possible following some surgical operations, such as a radical prostatectomy, due to the development of a tight fibrosis that forms in the retro-pubic space. Therefore, implantation of the device is performed as a preventive means during the operation.

Implantation may be performed during operation or after operation in case of persisting or significant incontinence. In cases where patients have a high risk of incontinence due to weak muscles, other anatomical conditions, and/or advanced prostate cancer, preventive implantation (i.e. during radical prostatectomy) may be beneficial so that, if incontinence occurs post-operation, the device may be adjusted without reoperation. During operation, the suspension members 22 are positioned and sutured to the pelvic fascia 30a. The second extremity 21a of the pair of threads 21 is positioned in the retro-pubic space along the midline. The tensioning means 30 is then implanted and realized in a similar manner as described above for females and the pair of threads 21 is locked in place by clip 24. Tensioning means 30 may be implanted after operation if needed in case of incontinence. The illustrative components shown in FIGs. 1A-6C are not intended to suggest any limitation as to the scope of use or functionality of embodiments of the disclosed subject matter. Neither should the illustrative components be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, any one or more of the components depicted in any of FIGS. 1A-6C may be, in some embodiments, integrated with various other components depicted therein (and/or components not illustrated), all of which are considered to be within the ambit of the disclosed subject matter.

As the terms are used herein with respect to ranges of measurements (such as those disclosed immediately above), "about" and "approximately" may be used, interchangeably, to refer to a measurement, position, or arrangement, that includes the stated measurement, position, or arrangement and that also includes any measurement, positions, or arrangements that are reasonably close to the stated measurement, position, or arrangement, but that may differ by a reasonably small amount such as will be understood, and readily ascertained, by individuals having ordinary skill in the relevant arts to be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, positions, or arrangements, adjustments made to optimize performance and/or structural parameters in view of differences in measurements, positions, or arrangements associated with other components, particu lar implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like.

Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

Claims

CLAIMS What is claimed is:

1. An implantable medical device for the treatment of urinary incontinence, comprising:

a tensioning means comprising a body, the body having a proximate end, a distal end opposite the proximate end, a top side, a bottom side opposite the top side, a first opening in the bottom side, and a second opening in the top side,

a mobile member located within the body, wherein the mobile member is movable along a longitudinal central axis within the body,

a balloon located within the body and positioned between the mobile member and the proximate end of the body,

a channel located within the mobile member, the channel being positioned vertically and perpendicular to the longitudinal central axis, and

an at least one thread entering through the first opening, extending through the channel, and exiting through the second opening.

2. The device of claim 1, wherein inflation of the balloon translates to movement of the mobile member along the longitudinal central axis and toward the distal end of the body.

3. The device of claim 1, wherein the distal end is a membrane.

4. The device of claim 1, further comprising a tubular member coupled to the balloon, the tubular member having a free end extending out of the proximate end of the body.

5. The device of claim 3, further comprising a subcutaneous port coupled to the free end of the tubular member.

6. An implantable medical device for the treatment of urinary incontinence, comprising:

a tensioning device comprising a body, the body having a proximate end, a distal end opposite the proximate end, a top side, a bottom side opposite the top side, a first opening in the bottom side, and a second opening in the top side,

a first orifice located within the mobile member, and

an at least one thread entering through the first opening, extending through the first orifice, and exiting through the second opening.

7. The device of claim 6, further comprising a second orifice in the proximate end of the body, the second orifice having a plurality of flexible members capable of bending upon exertion of a force.

8. The device of claim 6, the mobile member further comprising at least one tooth.

9. The device of claim 8, wherein within the body is at least one groove for containing the at least one tooth and preventing movement of the mobile member along the longitudinal central axis within the body.

10. The device of claim 6, wherein the mobile member is a needle.

11. An implantable medical device for the treatment of urinary incontinence, comprising:

a tensioning device comprising a body, the body having a proximate end and a distal end opposite the proximate end, a top side, a bottom side opposite the top side, a first opening in the bottom side, and a second opening in the top side,

an expandable wall covering the body,

an extensible channel located within the expandable wall and positioned centrally on the body, and

at least one thread entering through the first opening, extending through the extensible channel, and exiting th rough the second opening.

12. A method of using an implantable medical device for the treatment of urinary incontinence, the method comprising:

inserting at least one thread through a first incision and a second incision, positioning a first end of the at least one thread against a pelvic floor fascia, threading a second end of the at least one thread through the implantable medical device and positioning the implantable medical device between a supra-pubic area and the pelvic floor fascia,

tensioning the at least one thread such that the tensioning causes a raising of the first end of the at least one thread and an elevation of the pelvic floor fascia, and fixing a clip to the second end of the at least one thread to prevent movement of the at least one thread through the implantable medical device and a loss of tension in the at least one thread.

13. The method of claim 12, further comprising introducing a fluid into a subcutaneous port connected to the implantable medical device such that the fluid translates to movement of a movable member and tensioning of the at least one th read.

14. The method of claim 13, wherein the movable member is an inner cylinder.

15. The method of claim 13, wherein the movable member is a balloon.