US20050027161A1

Movatterモバイル変換

Info

Publication number: US20050027161A1
Application number: US10/932,414
Authority: US
Inventors: Timothy Cook; John Burton
Original assignee: Uromedica Inc
Current assignee: Uromedica Inc
Priority date: 1997-06-12
Filing date: 2004-09-02
Publication date: 2005-02-03
Also published as: US6645138B2; US20020151763A1

Abstract

An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable, self-sealing element having a continuous wall, including an inner surface defining a chamber. The adjustable element expands or contracts due to fluid volume introduced into the chamber for restricting a body lumen. After being implanted into a patient, the size of the adjustable element is altered by first locating the adjustable element implanted adjacent the body lumen, and then establishing fluid communication with the adjustable element. The volume of the adjustable element is then adjusted by either introducing or removing volume from the chamber of the adjustable element.

Description

FIELD OF THE INVENTION

The invention relates generally to implantable medical devices and in particular to implantable medical devices for treating urinary incontinence.

BACKGROUND OF THE INVENTION

Various implantable devices, such as distensible medical devices, are known in which the distensible medical devices are implanted into the tissue of a human to treat urinary incontinence. These devices have typically relied upon restricting or constricting the urethra of the patient to maintain continence.

U.S. Pat. No. 4,733,393 to Haber et al. is an attempt at such a proposed device. U.S. Pat. No. 4,733,393 relates to a hypodermically implantable genitourinary prosthesis which provides an extensible, inflatable tissue expanding membrane to be located in proximal urethral tissue to add bulk to these tissues for overcoming urinary incontinence by localized increase in tissue volume.

U.S. Pat. No. 4,802,479 to Haber et al. is an attempt at an instrument for dispensing and delivering material to an inflatable membrane of a genitourinary prosthesis within the tissues of a patient for overcoming urinary incontinence. U.S. Pat. No. 4,832,680 to Haber et al. relates to an apparatus for hypodermically implanting a genitourinary prosthesis comprising an extensible containment membrane for retaining a fluid or particulate matter which is injected from an external source.

U.S. Pat. No. 5,304,123 to Atala et al. relates to a detachable membrane catheter incorporated into an endoscopic instrument for implantation into the suburethral region of a patient. Also, U.S. Pat. No. 5,411,475 to Atala et al. discusses a directly visualized method for deploying a detachable membrane at a target site in vivo.

Once inflated, these devices maintain pressure on the urethra of the patient in an attempt to assist with continence. However, these devices are prone to being under or over inflated at time of implant, leading to undesirable postoperative results. For example, if the devices are overinflated it may cause the urethra to be restricted too tightly, and the patient is at risk for retention, a condition where the patient cannot pass urine. Such a condition could lead to kidney damage, necessitating major corrective surgery or at minimum use of self-catheterization to empty the bladder on a regular basis thus increasing the risk of urinary tract infection.

Furthermore, once these devices have been implanted within the patient, the only means of removing them in the event of a postoperative problem or device malfunction is through major surgery. Also, the devices are secured within the tissues of the patient, so there is the possibility of the devices migrating back along the pathway created in inserting them, a problem which has been noted with prior art devices. Thus, an important medical need exists for an improved implantable device for treating urinary incontinence.

SUMMARY OF THE INVENTION

The present invention provides an implantable device and a method for its use in restricting a body lumen. In one embodiment, the body lumen is a urethra, where the implantable device is used to coapt the urethra to assist the patient in urinary continence. The implantable medical device has the advantage of being adjustable both at the time of implantation and postoperatively. This postoperative adjustability of the implantable medical device allows a physician to regulate the amount of pressure applied to the urethra to ensure continence of the patient and to minimize iatrogenic effects.

In one embodiment of the invention, a patient's incontinence is treated by positioning one or more of the implantable devices adjacent to at least one side of a patient's urethra so as to adjust liquid flow resistance in the urethra This is accomplished by using the implantable devices to coapt the patient's urethra so as to maintain a transverse cleft or slit structure of the collapsed urethra and thereby provide sufficient flow resistance to ensure continence, while still allowing the patient to consciously discharge urine when necessary.

The device according to one embodiment of the invention is intended S to work immediately adjacent to the urethral wall of a patient to create an increase in urethral coaptation and flow resistance. However, in the prior art devices any tissue change which may occur postoperatively such as a reduction in tissue edema associated with the procedure may cause a reduction in clinical effect because of the reduced coaptation and resistance after the swelling has subsided. Although some minor degree of adjustability is available at the time of implantation in the prior art devices, not until the availability of the present invention is it possible to access the implanted device and adjust the membrane volume after implantation in a postoperative manner.

In one embodiment, the implantable device for treating urinary incontinence comprises an adjustable element having a continuous wall or membrane, where the wall includes an inner surface defining a chamber. The continuous wall is constructed of at least one material that is substantially self-sealing, and therefore, is able to withstand multiple punctures, for example from non-coring hypodermic needles, during postoperative adjustments of the adjustable element. In one embodiment, the continuous wall is constructed of a biocompatible resiliently elastomeric polymer or polymer blend of polyurethane, silicone, or the like. In an additional embodiment, the continuous wall of the adjustable element has an outer surface generally defining a sphere. In yet another embodiment, the continuous wall has an outer surface generally defining an elongate body having semi-spherical end portions.

During the postoperative adjustments, the adjustable element is expanded or contracted (ie., the volume of the adjustable element is increased or decreased) due to fluid volume introduced into the chamber. In one embodiment, fluid volume is introduced into the chamber through a hollow non-coring needle, such as a hypodermic needle, inserted through the wall of the adjustable element. The self-sealing ability of the wall allows for such adjustments by needles during one or more postoperative occasions without compromising the pressure retaining ability of the wall of the adjustable element.

In an additional embodiment, the implantable device includes one or more reinforcing structures positioned between the inner surface and an outer surface of the continuous wall. In one embodiment, woven or layered fibers of polyester, nylon, polypropylene, polytetrafluoroethylene (such as TEFLON) or other polymers having a high durometer measure or high modulus constitute the reinforcing structures. The reinforcing structures help to maintain structural integrity and the shape of the adjustable element during the initial inflation and any postoperative adjustments made thereafter.

In an additional embodiment, the continuous wall of the adjustable element has a porous polymer structure that allows the movement of water between the outer surface and the inner surface. A hydrophilic polymer is substantially encapsulated in the chamber, where the hydrophilic polymer absorbs water to expand the implantable device. Once implanted within a patient, the volume of the adjustable element is altered (ie., expanded or contracted) during implantation and/or postoperatively by introducing or removing the hydrophilic polymer from the chamber. In one embodiment, the hydrophilic polymer is hyaluronic acid, polyvinylpyrrolidone, polyethylene glycol, or carboxy methyl cellulose.

In an additional embodiment, the implantable medical device includes a tubular elongate body connected to and sealed to the adjustable element. The tubular elongate body includes a first interior passageway extending longitudinally in the tubular elongate body from a first port at the proximal end to a second port in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the expandable element by applied fluid volume introduced through the first port.

The tubular elongate body further includes a second interior passageway extending longitudinally in the tubular elongate body from a proximal opening through the peripheral surface positioned between the proximal and the distal end to a distal opening through the distal end of the tubular elongate body. This second interior passageway is of sufficient diameter to receive and guide an obturator for the insertion of the implantable device into a human body.

This embodiment of the implantable device also includes a rear port element coupled to the proximal end of the tubular elongate body. The rear port element including a cavity in fluid communication with the first port of the first interior passageway. An elastic septum is included on the rear port element, and is retained in the rear port element by a clap ring located around the rear port element.

An important improvement provided by one embodiment of the present invention resides in the ability to access the implanted rear port element located close to the surface of the patient's skin to adjustably restrict the urethra. This is accomplished by controlling the volume of a fluid, such as a flowable material, in the adjustable element after it has been implanted in the patient. Suitable flowable materials for introduction into the expandable membrane include a saline liquid, a flowable gel, or a slurry of small particles such as silicone in a fluid carrier. Moreover, the flowable material may be made radiopaque to facilitate fluoroscopic visualization for postoperative inspection.

The post implantation, or postoperative, urethral restriction is realized by the adjustable element acting on tissue adjacent to the walls of the urethral lumen and forcefully closing the urethral lumen. Voiding of urine from the bladder only occurs when the intravesicular pressure overcomes the resistance established by the adjustable element.

An important feature of the implantable device of the present invention relates to the adjustable element or membrane which is accessible for subsequent adjustment in volume through the rear port element located under a patient's skin, remotely from the adjustable element. Another important feature of the present invention over the prior art devices is the convenient in vivo postoperative adjustability of both pressure and size of the adjustable element.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, where like numerals describe like components throughout the several views:

FIG. 1(A-D) is a schematic view of an adjustable element according to one embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of the adjustable element ofFIG. 1;

FIG. 3 is one embodiment of reinforcing structures within the continuous wall of the adjustable element;

FIG. 4 is one embodiment of an implantable device according to the present invention;

FIG. 5 is a longitudinal cross-sectional view of the implantable device ofFIG. 4;

FIG. 6 is a cross-sectional view taken along line6-6 ofFIG. 5;

FIG. 7 is a schematic view of an adjustable element according to one embodiment of the present invention;

FIG. 8 is a schematic cross-sectional view of the adjustable element ofFIG. 7;

FIG. 9 is one embodiment of an obturator inserted into body tissue to an implant location adjacent a body lumen of a patient prior to insertion of the implantable device;

FIG. 10 is one embodiment of the implantable device placed over an obturator and partially advanced to the desired location with the adjustable element being deflated;

FIG. 11 is one embodiment of the implantable medical device implanted within the body tissue with the adjustable element expanded to cause the adjustable restriction of the body lumen;

FIG. 12 is a partial view of one embodiment of the implantable medical device implanted within the body tissue;

FIG. 13 is a cross-sectional view taken along line13-13 ofFIG. 11;

FIG. 14 is one embodiment of adjusting an implanted adjustable element; and

FIG. 15 is one embodiment of adjusting an implanted adjustable element.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description, reference is made to the accompanying drawings which form a part hereof and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice and use the invention, and it is to be understood that other embodiments may be utilized and that logical, and structural changes may be made without departing from the spirit and scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense and the scope of the present invention is defined by the appended claims and their equivalents,

In FIGS.1(A-D) and2 of the drawings, there is shown animplantable device20 for restricting a body lumen. In one embodiment, theimplantable device20 is for treating ureteral reflux of a patient by implanting at least one of the implantable devices adjacent one or both ureter proper. In an alternative embodiment, theimplantable device20 is for treating urinary incontinence by implanting at least one of the implantable devices adjacent the urethra.

Implantable devices designed for treating urinary incontinence are typically referred to as a genitourinary prosthesis. Many designs for genitourinary prosthesis have been proposed. In one such proposed embodiment, genitourinary prosthesis are comprised of elastomeric, elliptoidally or spherically-shaped containment membranes which have an interior chamber designed to receive a measured supply of fluid to inflate the prosthesis. One such description of a genitourinary prosthesis is also provided in a co-pending U.S. patent application Ser. No. ______, entitled “Implantable Device and Method for Adjustably Restricting a Body Lumen” filed Jun. 12, 1997, by Burton et al., which is hereby incorporated by reference in its entirety.

In treating urinary incontinence, the prosthesis are delivered within the body to a location that is typically within the periurethral tissue and adjacent to the urethra to enable a patient to overcome urinary incontinence by means of increasing both localized tissue volume and passive occlusive pressure upon the urethral mucosa.

The prosthesis is typically mounted on a hollow non-coring needle, such as a hypodermic needle, which is releasably connected to a fluid source, such as a syringe element. In order to facilitate inserting the prosthesis into position, the prosthesis is housed within a tubular body, such as a trocar tube, where the tubular body is designed to penetrate the tissues of the patient, thus allowing the proper placement of the prothesis. Alternatively, the prosthesis could be mounted at or on a distal end of a trocar tube to allow for delivery of the prosthesis within the patient.

Once the prosthesis has been positioned within the body, it is inflated by infusing a measured supply of fluid volume, including fluid volume having particulate matter into the interior of the of the membrane of the prosthesis. Fluids suitable for infusing into the prothesis include, but are not limited to, sterile saline solutions, polymer gels such as silicone gels or hydrogels of polyvinylpyrrolidone, polyethylene glycol, or carboxy methyl cellulose for example, high viscosity liquids such as hyaluronic acid, dextran, polyacrylic acid, or polyvinyl alcohol for example, or liquids that coagulate on contact with body fluids. The fluids also include fluids having a variety of particulate matter, and include, but are not limited to particles have a spherical shape, an elongate shape, or particles having a cross sectional star shape. Once the prothesis has been inflated, the needle is withdrawn from the prosthesis and the tubular body is withdrawn from the body, leaving the inflated prothesis in position.

FIGS. 1A and 2 shows one embodiment of animplantable device20 for restricting a body lumen comprising an adjustable, self-sealingelement22 having acontinuous wall24. Thecontinuous wall24 includes aninner surface26 defining achamber28. Furthermore, thecontinuous wall24 is constructed of at least one material that is substantially self-sealing to allow for theadjustable element22 to be expanded or contracted due to fluid volume introduced into thechamber28. In one embodiment, thecontinuous wall24 itself is constructed of a self-sealing material. In an alternative embodiment, theinner surface26 of theadjustable element22 has a material that imparts a self-sealing ability to theadjustable element22 such as crosslinked silicone gel, polyvinylpyrrolidone, or karaya gum for example.

FIGS.1B-D show several embodiments of genitourinary prosthesis implanted in a patient.FIG. 1B is one embodiment of positioning theadjustable element22 of the present invention, where oneadjustable element22 is positioned adjacent aurethra23 of the patient. In an alternative embodiment,FIG. 1C shows two of theadjustable element22 positioned adjacent theurethra23, where each of theadjustable element22 are generally disposed on opposite sides of and in a similar plane perpendicular to theurethra23. In an additional embodiment,FIG. 1D shows two of theadjustable element22 positioned adjacent theurethra23, where each of theadjustable element22 are generally disposed on opposite sides of theurethra23, with each of theadjustable elements22 in generally a different plane perpendicular the urethra23 to create at least two portions of the urethra having a coapted portion and leading to the urethra23 having a tortious configuration. In an alternative embodiment, theadjustable element22 is placed next to a ureter proper.

In one embodiment, thecontinuous wall24 is intended and designed to be pierced by hollow non-coring needles on one or more occasions for adjusting the volume of the adjustable element during both the implanting of the adjustable element and during subsequent postoperative adjustment of the adjustable element. As such, thecontinuous wall24 is constructed of a material that is tear-resistant and biocompatible. In one embodiment, the material is also substantially self-sealing during and after being pierced by a hollow non-coring needle to maintain fluid volume within thechamber28 of the adjustable element.

In an additional embodiment, theadjustable element22 has two or morecontinuous walls24, where thecontinuous walls24 are arranged concentrically with one of two or morecontinuous walls24 being within another continuous wall24 (not shown). The two or morecontinuous walls24 of the present embodiment are separated from each other due to the presence of fluid between thecontinuous walls24. In one embodiment, the chambers created by each of thecontinuous walls24 are filled with any combination of fluids described within this detailed description.

In one embodiment, the continuous wall is constructed of a biocompatible resiliently elastomeric polymer or polymer blend of polyurethane, silicone, or the like. In this embodiment, thecontinuous walls24 stretch as theadjustable element22 expands or contracts to a desired size. In an alternative embodiment, the continuous wall is constructed of a biocompatible non-resilient polymer or polymer blend of polyethylene, polytetraflouroethylene, polystyrene, or polyesteretherketone (PEEK). In this embodiment, thecontinuous wall22 of theadjustable element22 expand to a predetermined shape. The adjustable element is formed into a variety of shapes. In one embodiment, theouter surface32 of thecontinuous wall24 generally defines a spherical shape. In an alternative embodiment, theouter surface32 of thecontinuous wall24 generally defines an elongate body having semi-spherical end portions. In one embodiment, aadjustable element22 being constructed of a biocompatible resiliently elastomeric polymer or polymer blend typically retains the same general cross-sectional shape deflated as when inflated. In an alternative embodiment, when theadjustable element22 is constructed of a biocompatible non-resilient elastomeric polymer or polymer blend the deflatedadjustable element22 typically has a configuration in which thecontinuous wall24 has a folded structure which as theadjustable element22 is inflated changes to take on a preformed cross-sectional shape and size and/or diameter.

Referring now toFIG. 3, there is shown an embodiment of a portion of thecontinuous wall24, where thecontinuous wall24 further includes one or more reinforcingstructures30 positioned between theinner surface26 and anouter surface32 of thecontinuous wall24. In one embodiment, the one or more reinforcingstructures30 are designed to support the structural integrity of thecontinuous wall24, helping to provide the substantially self-sealing nature of theadjustable element22, and to assist in retaining particles within thechamber28 of theadjustable element22. In one embodiment, the one or more reinforcingstructures30 are fibers constructed from the group comprising one or more of polyester, nylon, polypropylene, polytetrafluoroethylene (such as TEFLON) or other polymers having a high durometer measure or high modulus constitute the reinforcing structures.

In one embodiment, the fibers of the one or more reinforcingstructures30 are woven into a support structure that is positioned between theinner surface26 and theouter surface32 of thecontinuous wall24. In an additional embodiment, the fibers of the one or more reinforcingstructures30 are less elastic than thecontinuous wall24, and the woven support structure has a lose weave configuration to allow for the support structure to expand or contract with the expansion and contraction of thecontinuous wall24 of theadjustable element22.

In an alternative embodiment, the fibers of the one or more reinforcingstructures30 are substantially non-elastic and are arranged in a woven configuration, where the fibers have a kinked structure that allows them to expand or contract with the expansion and contraction of thecontinuous wall24 of theadjustable element22.

The one or more reinforcingstructures30 provide theadjustable element22 with reinforced structural integrity and an increased ability to retain infused particles within thechamber28 of theadjustable element22. In one embodiment, the fibers of the one ore more reinforcingstructures30 woven into the support structure provide a “rip-stop” function. As an example, the woven support structure allows for rip-stop protection from tears in thecontinuous wall24 due to insertion and removal of hollow non-coring needles through thecontinuous wall24. In an additional embodiment, the woven support structure prevents the migration of particle from thechamber28, where the particles are used to inflate theadjustable element22. In one embodiment, the particles are prevented from migrating out of thechamber28 due to the tightness of the weave of the support structure.

As previously mentioned, a variety of particulate matter is suitable for infusing into thechamber28 of theadjustable element22. The particulate matter is typically suspended in a carrier fluid, or lubricious fluid, however, this is not necessary. Examples of particulate matter shapes include collapsible hollow spheres or those having multiple projecting arms or structures from a central axis. In one embodiment, the structure of the particulate matter has a larger diameter than both the inner diameter of the hollow non-coring needle and the opening in the woven structure of the reinforcingstructure30. To inject the particulate matter into thechamber28 of theadjustable element22, the surface of the particulate matter is physically distorted to allow it to pass through the inner diameter of the hollow non-coring needle, such as the hollow spheres collapsing or the projecting arms bending. Once the particulate matter has passed through the hollow non-coring needle, the particulate matter expands back to a size greater than the hole created by the needle, thus making the device self sealing.

In an alternative embodiment, the particulate matter is an elongate body, such as a tubular elongate structure, such that the particulate matter can pass longitudinally through the hollow non-coring needle, but once inside theadjustable element22 their random orientation would essentially prevent them from passing back through any needle hole created by the hollow non-coring needle.

In an alternative embodiment, the inner diameter of the hollow non-coring needle is sufficient to pass the particulate matter, however the structure of the particulate matter has a larger diameter than the openings in the woven structure of the reinforcingstructure30. In this embodiment, inserting the hollow non-coring needle distorts the mesh of the woven structure of the reinforcingstructure30 to allow the hollow noncoring needle to pass through thecontinuous wall24 and into thechamber28.

Alternatively, the particle is made of a hydrophillic material such as polyvinylpyrrolidone, polyethylene glycol, carboxy methyl cellulose, hyaluronic acid, or the like, which expands once inside theadjustable element22 due to the absorption of liquid that is either delivered with the particles or passes through at least a portion of thecontinuous wall24 of theadjustable element22.

In an additional embodiment, adetectable marker34 is imbedded in thecontinuous wall24 of theadjustable element22. Thedetectable marker34 allows theadjustable element22 to be located and its shape to be visualized within the tissues of a patient using any number of visualization techniques which employ electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker is constructed of tantalum and the visualization techniques used to visualize theadjustable element22 are x-ray or fluoroscopy as are known in the art. In an additional embodiment, the one or more reinforcingstructures30 are labeled with tantalum to allow theadjustable element22 to be visualized using x-ray, fluoroscopy or other visualization techniques as are known in the art.

Referring now toFIGS. 4, 5, and6 there is shown an alternative embodiment of theimplantable device20 further includes a tubularelongate body36, where the tubularelongate body36 has aperipheral surface38, aproximal end40 and adistal end42. Theadjustable element22 has at least one opening through thecontinuous wall24 to which theperipheral surface38 is connected to and sealed to theadjustable element22. The tubularelongate body36 is inserted through thefirst opening44 and thesecond opening46 such that thedistal end42 of theelongate body36 partially extends beyond theouter surface32 of theadjustable element22. Theperipheral surface38 is then sealed to the walls creating thefirst opening44 and thesecond opening46. In one embodiment, theperipheral surface38 is sealed to the openings using a chemical or polymer adhesive, such as silicone. In an alternative embodiment, theperipheral surface38 is sealed to the openings using sonic welding techniques as are known in the art.

The tubularelongate body36 further includes a firstinterior passageway48 extending longitudinally in the tubularelongate body36 from afirst port50 at theproximal end40 to asecond port52 in fluid communication with thechamber28 of the implantable device for adjustably expanding or contracting theexpandable element22 by applied fluid volume introduced through thefirst port50.

In an additional embodiment, the tubularelongate body36 further includes a secondinterior passageway54 extending longitudinally in the tubularelongate body36 from aproximal opening56 through theperipheral surface38 positioned between theproximal end40 and thedistal end42 to adistal opening58 through thedistal end42 of the tubularelongate body36. In one embodiment, the secondinterior passageway54 is of sufficient diameter to receive and guide an obturator for the insertion of theimplantable device20 into a human body. In an alternative embodiment, the obturator is removably attached at thedistal end42 and passes outside theexpandable element22 and along side theelongate body36 to allow placement of the device without the need for the secondinterior passageway54.

Theimplantable device20 further includes arear port element60 coupled to theproximal end40 of the tubularelongate body36. In one embodiment, therear port element60 is coupled to theproximal end40 of theelongate body36 using chemical adhesives, or alternatively, using sonic welding techniques as are known in the art. In an additional embodiment, therear port element60 andproximal end40 are formed together in an polymer extrusion process or polymer casting process as are known in the art.

Therear port element60 includes acavity62, where thecavity62 is in fluid communication with thefirst port50 of theelongate body36. Therear port element60 also includes anelastic septum64 through which thecavity62 is accessed. Theelastic septum64 is retained in therear port element60 by aclamp ring66 located around therear port element60. In one embodiment, theclamp ring66 is made of a biocompatible material, such as, for example, titanium. In one embodiment, theelastic septum64 is made of a biocompatible material, such as, for example, silicone or polyurethane.

Referring now toFIGS. 7 and 8, there is shown an alternative embodiment of theimplantable device20 for treating urinary incontinence or ureteral reflux. Theimplantable device20 comprises anadjustable element100 having acontinuous wall102, including aninner surface104 and anouter surface106, where theinner surface104 defines achamber108. Thecontinuous wall102 also has at least a portion of the continuous wall that is constructed of a porous polymer structure that allows the movement of water between theouter surface106 and theinner surface104. Ahydrophilic polymer110 is substantially encapsulated in thechamber108, where thehydrophilic polymer110 absorbs water. As thehydrophilic polymer110 absorbs water, it causes thechamber108 to expand, thus enlarging theadjustable element100.

In one embodiment, thecontinuous wall102 is intended and designed to be pierced by hollow non-coring needles on one or more occasions for adjusting the volume of the adjustable element during both the implanting of the adjustable element and during subsequent postoperative adjustment of the adjustable element. As such, thecontinuous wall102 is constructed of a material that is substantially self-sealing during and after being pierced by a hollow non-coring needle to maintain fluid volume within thechamber108 of the adjustable element, and the adjustable element expands or contracts by introducing or removing the hydrophilic polymer from the chamber.

Referring now to.FIG. 8, there is shown an embodiment of a portion of thecontinuous wall102, where thecontinuous wall102 further includes one or more reinforcingstructures120 positioned between theinner surface104 and theouter surface106 of thecontinuous wall102. In one embodiment, the one or more reinforcingstructures120 are fibers constructed from the group comprising one or more of polyester, nylon, polypropylene, polytetrafluoroethylene (such as TEFLON) or other polymers having a high durometer measure or high modulus constitute the reinforcing structures.

In one embodiment, the fibers of the one or more reinforcingstructures120 are woven into a support structure that is positioned between theinner surface104 and theouter surface106 of thecontinuous wall102. In an additional embodiment, the fibers of the one or more reinforcingstructures120 are less elastic than thecontinuous wall102. The woven support structure, in one embodiment, has a lose weave configuration to allow for the support structure to expand or contract with the expansion and contraction of thecontinuous wall102 of theadjustable element100.

In an alternative embodiment, the fibers of the one ore more reinforcingstructures120 are substantially non-elastic and are arranged in a woven configuration, where the fibers have a kinked structure that allows them to expand or contract with the expansion and contraction of thecontinuous wall102 of theadjustable element100.

The one or more reinforcingstructures120 provide theadjustable element100 with reinforced structural integrity and an increased ability toretain particles within thechamber108 of theadjustable element100. In one embodiment, the fibers of the one ore more reinforcingstructures120 woven into the support structure provide a “rip-stop” function. As an example, the woven support structure allows for rip-stop protection from tears in thecontinuous wall102 due to insertion and removal of hollow non-coring needles through thecontinuous wall102. In an additional embodiment, the woven support structure prevents the migration of particle from thechamber108, where the particles are used to inflate theadjustable element100. In one embodiment, the particles are prevented from migrating out of thechamber108 due to the tightness of the weave of the support structure.

In an additional embodiment, a detectable marker122 is imbedded in thecontinuous wall102 of theadjustable element100. The detectable marker122 allows theadjustable element100 to be located and its shape to be visualized within the tissues of a patient using any number of visualization techniques which employ electromagnetic energy as a means of locating objects within the body. In one embodiment, the detectable marker is constructed of tantalum and the visualization techniques used to visualize theadjustable element100 are x-ray or fluoroscopy as are known in the art. In an additional embodiment, the one or more reinforcingstructures120 are labeled with tantalum to allow theadjustable element100 to be visualized using x-ray, fluoroscopy or other visualization techniques as are known in the art.

The hydrophilic material used within thechamber108 of theadjustable element100 is selected from a group comprising one or more of polyvinylpyrrolidone, polyethylene glycol, carboxy methyl cellulose, or hyaluronic acid. In one embodiment, the hydrophilic polymer have a particular structure, where the hydrophilic polymer takes the form of discrete, individual polymeric units. Additionally, the particulate structure of the hydrophilic polymer has an average diameter that is greater than an average diameter of pores of the porous polymer structure. In an additional embodiment, the porous polymer structure of thecontinuous wall102 has openings that are less than or equal to 200 micrometers.

In one embodiment, thecontinuous wall102 is constructed of a biocompatible resiliently elastomeric polymer or polymer blend of polyurethane, silicone, or the like. In this embodiment, thecontinuous wall102 stretches as theadjustable element100 expands or contracts to a desired size. In an alternative embodiment, thecontinuous wall102 is constructed of a biocompatible non-resilient polymer or polymer blend of polyethylene, polyesterterethalate, or high modulus polystyrene, or polyesteretherketone. In this embodiment, thecontinuous wall102 of theadjustable element100 expand to a predetermined shape. Theadjustable element100 is formed into a variety of shapes. In one embodiment, theouter surface106 of thecontinuous wall102 generally defines a spherical shape. In an alternative embodiment, theouter surface106 of thecontinuous wall102 generally defines an elongate body having semi-spherical end portions. In one embodiment, aadjustable element102 being constructed of a biocompatible resiliently elastomeric polymer or polymer blend typically retains the same general cross-sectional shape deflated as when inflated. In an alternative embodiment, when theadjustable element102 is constructed of a biocompatible non-resilient elastomeric polymer or polymer blend the deflatedadjustable element102 typically has a configuration in which thecontinuous wall102 has a folded structure which as theadjustable element100 is inflated changes to take on a preformed cross-sectional shape and size and/or diameter.

Referring now toFIGS. 9 and 10, there is shown an embodiment of the method of implanting one embodiment of theimplantable device assembly200 of the present invention for restricting a body lumen in a patient. Theimplantable device assembly200 is adapted to be surgically implanted intobody tissue202 of a patient adjacent to a body lumen for coaptating the body lumen.

Theimplantable device assembly200 comprises anobturator206 having a cuttingend208 adapted for being inserted as a guide member intobody tissue202 to locate a portion of the obturator adjacent the body lumen to be restricted. Referring toFIG. 9, a physician after locating the body lumen such as theurethra23 of a patient, first makes a small incision in skin of thepatient211 and inserts theobturator206 in the body tissue to a desired location adjacent theurethra23. This procedure is usually carried out under a local anesthetic with visual guidance, for instance under fluoroscopy by the physician. Theobturator206 is of sufficient strength and rigidity to allow its insertion into thetissue202 of the patient adjacent and parallel with theurethra23.

Referring toFIG. 10, an implantablemedical device210, adapted for being surgically implanted into thetissue202 adjacent to the body lumen, is then positioned onto theobturator206 and advance into thetissue202 of the patient. In one embodiment, theobturator206 is inserted near themeatus urinarius204 and advance through the periurethral tissue adjacent theurethra23. In one embodiment, a detent or mark is provided on theobturator206 which when aligned with a feature on the implantablemedical device210, such as arear port element60, ensures that an implantablemedical device210 is appropriately placed at the correct depth in the patient's body tissue. In an additional embodiment, theelongate body36 of the implantablemedical device210 is available having a variety of lengths to accommodate the patient's physiological structure so as to facilitate placement of the elastic septum on therear port element60 near the patient's skin. Alternatively, theelongate body36 effective length could be made adjustable by it having a helical shape similar to that of a coiled spring.

FIG. 10 shows one embodiment of the implantablemedical device210, where the implantablemedical device210 includes anadjustable element22, a tubularelongate body36, and arear port element60. Theadjustable element22 has a continuous wall, including an inner surface defining a chamber. The tubularelongate body36, has aperipheral surface38, aproximal end40 and adistal end44, where the peripheral surface is connected to and sealed to theadjustable element22. The tubular elongate body includes a first interior passageway and a second interior passageway, the first interior passageway extending longitudinally in the tubular elongate body from a first port at the proximal end to a second port in fluid communication with the chamber of the implantable device for adjustably expanding or contracting theexpandable element22 by applied fluid volume introduced through the first port.

The second interior passageway also extends longitudinally in the tubularelongate body36 from aproximal opening56 through theperipheral surface38 positioned between theproximal end40 and thedistal end44 to adistal opening58 through the distal end of the tubularelongate body42. The second interior passageway being of sufficient diameter to receive and guide theobturator206 for the insertion of the implantable device into the patient's body. Therear port element60 of the implantablemedical device210 is coupled to theproximal end40 of the tubularelongate body36, where the rear port element includes a cavity in fluid communication with the first port of the first interior passageway.

In one embodiment, once theobturator206 has been inserted into the patient's tissue, the portion of theobturator206 extending from the patient's body is inserted into thedistal opening58 of the second interior passageway. The implantablemedical device210 is then advance or moved along or over theobturator206 to position theadjustable element22 adjacent the body lumen to be restricted and to position the rear port element subcutanesouly. In one embodiment, theadjustable element22 is positioned adjacent a urethra. In an additional embodiment, two or more of the implantablemedical devices220 are implanted within the body tissue adjacent a urethra. Theobturator206 is then withdrawn from the tissue of the patient by pulling theobturator206 through theproximal opening56 of the second interior passageway, leaving the implantablemedical device210 in position.

Referring now toFIGS. 11, 12 and13 there is shown one embodiment of the implantablemedical device210 implanted in the tissue of a patient for restricting a body lumen. In one embodiment, the body lumen is the urethra23 and the implantablemedical device210 has been implanted in the periurethral tissue of the patient.

After the implantablemedical device210 has been advanced over theobturator206 so that the contractedadjustable element22 is in the desired position adjacent to theurethra23, theurethra23 is restricted to a desired degree by piercing the elastic septum with a needle of a syringe and injecting a flowable material through the first interior passageway into theadjustable element22. The physician may determine the desired degree of restriction ofurethra23 by means such as infusing fluid through the urethra23 past the restriction and measuring the back pressure. As illustrated byFIG. 11 the source of flowable material is usually asyringe220 with ahollow non-coring needle222 used to pierce the elastic septum, however alternate fluid containers with means for making a reversible connection to implantablemedical device210 could be used. The flowable material may be, for example, a saline solution, a flowable gel, or a slurry of particles in a liquid carrier. It may be advantageous to make the flowable material radiopaque so that the degree of membrane inflation may be viewed by x-ray.

An alternative method of delivery of the implantablemedical device210 could be to first withdrawobturator206 from the body tissue and then inflateadjustable element22. A further alternative would be to first place the implantablemedical device210 over theobturator206 outside the body and then insert them both into the body tissue as a unit. To facilitate this latter procedure, it may be desirable that there be some friction between theobturator206 and the second interior passageway.

After the implantable device has been properly positioned with theadjustable element22 located near theurethra23 and the elastic septum inrear port element60 located near the skin, the implantablemedical device210 is injected with a flowable material from thesyringe220. Once filling of theadjustable element22 is complete, theobturator206 is withdrawn from the implantablemedical device210 leaving the adjustable implantable medical device in the body tissue. Then the skin incision is closed over therear port element60 by means such as asuture230 as shown inFIG. 12.

As described, one feature of this invention relates to the adjustability of theadjustable element22 postoperatively. This adjustability is effected because the elastic septum is located remote from theadjustable element22 but near and under the patient's skin. Therear port element60 and the elastic septum are located by, for instance, manual palpation of the skin region and the needle of the syringe is inserted through the skin and septum so as to add or remove material from theadjustable element22, thus increasing or decreasing the restriction of the body lumen.

Referring toFIG. 13, there is shown one embodiment of theadjustable element22 implanted adjacent a body lumen. Theadjustable element22 is shown in an expanded state, such that it increases both localized tissue volume and passive occlusive pressure upon the body lumen. In one embodiment, the body lumen is theurethra23 of a patient, and the patient's incontinence is treated by positioning one or more of theadjustable elements22 of the implantablemedical devices210 adjacent the urethra23 so as to allow the physician to adjust liquid flow resistance in theurethra23. This is accomplished by the implantable devices coapting the patient's urethra as previously described so as to maintain a transverse cleft or slit structure of the collapsed urethra and thereby provide sufficient flow resistance, so that enough pressure is provided to maintain continence, but not so much pressure as to prevent the patient from consciously urinating.

Referring now toFIGS. 14 and 15 there is shown embodiments of postoperatively adjusting an implantedadjustable element22. Theadjustable element22 having been implanted adjacent a body lumen within a patient, is first located within the tissues of the patient. In one embodiment, locating theadjustable element22 is accomplished using fluoroscopy, x-ray, or ultrasound visualization techniques as are known in the art. Once the adjustable element has been located within the tissue of the patient, the physician then proceeds to establish fluid communication with theadjustable element22. InFIG. 14 oneadjustable element22 having generally a spherical configuration is shown positioned adjacent a body lumen, such as a urethra or a ureter proper, of a patient. Alternatively,FIG. 15 shows an additional embodiment where twoadjustable elements22 each having a configuration that is generally an elongate body having semi-spherical end portions.

In one embodiment, fluid communication is established with the adjustable element by first inserting acatheter structure300 into the urethra of the patient. In one embodiment, thecatheter structure300 has anelongate body302

proximal end

304 and adistal end306. Thecatheter structure300 includes a fluid passageway extending longitudinally within thecatheter structure300 from aninlet port308 at theproximal end304 to aoutlet port310 at thedistal end306. In one embodiment, ahollow non-coring needle312 is coupled to theoutlet port310. In an additional embodiment, the fluid passageway housed within theelongate body302 of thecatheter structure300 moves longitudinally within theelongate body302 to allow thehollow non-coring needle312 coupled to theoutlet port310 to, in one position, extend beyond thedistal end306 of theelongate body302, and in another position to be housed completely within theelongate body302 of thecatheter structure300.

In an additional embodiment, the path of thehollow non-coring needle312 as it is extended beyond thedistal end306 of thecatheter structure300 deflects away from a plane that is generally parallel with the longitudinal axis of theelongate body302 of thecatheter structure300. In one embodiment, this allows thehollow non-coring needle312 to penetrate through the urethral tissue and into the continuous wall of theadjustable element22. Thehollow non-coring needle312 is then advance into the chamber of theadjustable element22 at which point the physician adjusts the volume of theadjustable element22. In one embodiment, the volume of the adjustable element is adjusted by passing fluid and/or particles through the hollow non-coring needle to adjustably contract or expand theadjustable element22 due to fluid volume introduced into the chamber.

FIG. 15 shows an alternative embodiment for adjusting theadjustable element22, where thecatheter structure300 is first inserted through the tissues of the patient. The distal end of thecatheter structure300 is then aligned with the outside surface of theadjustable element22 and thehollow non-coring needle312 is advance through the continuous wall of the adjustable element and into the chamber to allow the adjustable element to be either expanded or contracted by passing fluid, particles and/or hydrophilic polymer through thehollow non-coring needle312 as previously described.

In an additional embodiment, theelongate body302 of thecatheter structure300 acts as a needle stop to limit the depth to which the needle is allow to penetrate the implantedadjustable element22. In an additional embodiment, theouter surface32 of the adjustable element is secured to thecatheter structure300 during the insertion of thehollow non-coring needle312 into theadjustable element22. In one embodiment, a suction passageway extends longitudinally within theelongate body302 to allow thedistal end306 of thecatheter structure300 to be secured to theouter surface32 of theadjustable element22 by a negative or vacuum pressure applied through the suction passageway. Once thecatheter structure300 is secured to theadjustable element22, thehollow non-coring needle312 is extended from thecatheter structure300 to pierce the continuous wall of theadjustable element22 and allow for its volumetric adjustment.

Claims

1-21. (Cancelled).

22. A device adapted for implantation in body tissue adjacent to a lumen, the device comprising:

an adjustable element adapted to coapt the lumen, the adjustable element including a continuous wall having an inner surface defining a chamber, wherein at least a portion of the continuous wall includes a porous structure allowing fluid to move across the continuous wall;

a hydrophilic material substantially encapsulated in the chamber;

a tubular elongate body having a proximal end and a distal end, the tubular elongate body including a first interior passageway extending longitudinally in the tubular elongate body from a first port at the proximal end to a second port in fluid communication with the chamber; and

a rear port element coupled to the proximal end of the tubular elongate body, the rear port element including a cavity in fluid communication with the first port of the first interior passageway and an elastic septum allowing access to the cavity by a needle.

23. The device ofclaim 22, wherein the tubular elongate body further comprises a second interior passageway extending longitudinally in the tubular elongate body from a proximal opening positioned between the proximal end and the distal end of the tubular elongate body to a distal opening through the distal end of the tubular elongate body.

24. The device ofclaim 22, wherein the hydrophilic material includes one or more of polyvinylpyrrolidone, polyethylene glycol, carboxy methyl cellulose, and hyaluronic acid.

25. The device ofclaim 22, wherein the hydrophilic material includes a hydrophilic polymer in a form of discrete, individual polymeric units.

26. The device ofclaim 22, further comprising a detectable marker imbedded in the continuous wall.

27. The device ofclaim 26, wherein the detectable marker is opaque to x-ray or fluoroscopy.

28. The device ofclaim 22, wherein the continuous wall is constructed of a biocompatible resiliently elastomeric polymer or polymer blend.

29. The device ofclaim 28, wherein the continuous wall is constructed of one or more of polyurethane and silicone.

30. The device ofclaim 28, wherein the adjustable element retains a general cross-section shape when being deflated.

31. The device ofclaim 22, wherein the continuous wall is constructed of a biocompatible non-resilient polymer or polymer blend.

32. The device ofclaim 31, wherein the continuous wall is constructed of one or more of polyethylene, polytetraflouroethylene, polystyrene, and polyesteretherketone.

33. The device ofclaim 31, wherein the adjustable element has a folded structure when being deflated.

34. The device ofclaim 22, wherein at least a portion of the continuous wall comprises at least one reinforcing structure.

35. The device ofclaim 34, wherein the reinforcing structure comprises fibers constructed from one or more of polyester, nylon, polypropylene, and polytetrafluoroethylene.