Bulking agents

<u>Technical Field</u>

0001The invention relates generally to the treatment of mammalian tissue through the process of bulking, and more specifically to the injection of bulking particles into a treatment region of a mammal.

<u>Background</u>

0002Urinary incontinence, vesicourethral reflux, fecal incontinence, and intrinsic sphincter deficiency (ISD), for example, are disorders that have responded to treatments with augmentative materials. Such disorders occur when the resistance to flow of bodily discharges decreases to the point where the resistance can no longer overcome the intra-abdominal pressure. Nearly all procedures developed to restore continence are based on restoring the lost resistance.

0003Surgical implantation of artificial sphincters has often been employed to treat patients suffering from urinary incontinence. The surgical implantation of the artificial sphincter commonly requires hospitalization, is relatively complex and expensive, and will usually require six to eight weeks of recovery time. Moreover, the procedure may be unsuccessful if the artificial sphincter malfunctions. As a result, additional surgery is required to adjust, repair, or replace the implant.

0004Urinary incontinence can also be treated using nonsurgical means. A common method to treat patients with urinary incontinence is periurethral injection of a bulking material. One such bulking composition is a Teflon^® paste known commercially as "Polytef' or "Urethrin." This paste is comprised of a fifty-fifty (50-50) by weight mixture of a glycerin liquid with Teflon^® (polytetrafluoroethylene (PTFE)) brand particles sold by DuPont. The glycerin is biodegradable, however, and over a period of time the glycerin dissipates into the body and is then metabolized or eliminated leaving only about fifty percent (50%) of the injected mixture (i.e., the Teflon^® particles) at the injection site. Consequently, to achieve the desired result, the surgeon typically overcompensate for the anticipated loss of bulking material by injecting a significantly larger amount of material than initially required. At the extreme, this overcompensation can lead to complete closure of the urethra, which could put the patient into temporary urinary retention. Additionally, the eventual dissipation of the glycerin complicates the surgeon's ability to visually gauge the appropriate amount of bulking material to inject. To avoid these over-bulking side effects, the surgeon may ultimately not inject enough bulking mixture, leading to the likelihood of a second or even a third procedure to inject additional material.

0005Further, the particle size in the Teflon^® paste bulking material if sufficiently small may allow the particles to migrate to other locations of the body, such as the lungs, brain, etc. Teflon^® particles have been known to induce undesirable tissue reaction and form Teflon^® induced granulomas in certain individuals.

0006In addition, the Teflon^® paste is typically highly viscous and can only be injected using a hypodermic needle held by an injection assist device. Use of an injection assist device may be required, because a surgeon would likely not have sufficient strength to force the highly viscous Teflon^® paste through a needle of any acceptable size.

0007Two alternatives to the Teflon^® paste are a collagen gel and carbon coated zirconium beads. One such commercially available product includes Contigen^®, available from CR Bard. The collagen gel is injected in the same manner as the Teflon^®paste and forms a fibrous mass of tissue around the augmentation site. This fibrous mass created by the collagen injection, however, also dissipates over time and is eventually eliminated by the patient's body. As a result, additional injections are periodically required.

0008Yet another bulking procedure includes the injection of swollen hydrogel particles. The swollen hydrogel particles exhibit relatively low injection forces by incorporating low molecular weight water-soluble organic compounds, along with water, in the particles. See, for example, <patcit id="pcit0001" dnum="US5813411A"><text>U.S. Patent Nos. 5,813,411</text></patcit> and <patcit id="pcit0002" dnum="US5902832A"><text>5,902,832 to Van Bladel et al</text></patcit>., and <patcit id="pcit0003" dnum="US5855615A"><text>U.S. Patent No. 5,855,615 to Bley et al</text></patcit>.

0009<patcit id="pcit0004" dnum="WO0023054A"><text>WO00/23054</text></patcit>, <patcit id="pcit0005" dnum="EP0826381A"><text>EP0826381</text></patcit> and <patcit id="pcit0006" dnum="EP0730847A"><text>EP0730847</text></patcit> separately describe a bulking agent for medical applications comprising a carrier and a plurality of spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the spherical polyvinyl alcohol particles.

0010<patcit id="pcit0007" dnum="WO03082359A"><text>WO03/082359</text></patcit> discloses a method for treating tissue which includes placing substantially spherical particles in the tissue. The particles are made from polyvinyl alcohol which are dispersed in a carrier, the carrier aiding at the delivery. Moreover, the particles and/or carrier comprise a lubricant.

0011<patcit id="pcit0008" dnum="EP0251695A"><text>EP0251695</text></patcit> discloses a lubricant in an injectable implant composition in order to improve intrudability.

0012Another alternative to the Teflon paste is a hard particle suspension. One such commercially available product is Durasphere^® available from Carbon Medical Technologies. These hard particles, for example carbon coated zirconium beads, are injected in a beta-glucan carrier. The beta-glucan is eliminated by the patient's body over time. As a result, additional injections may be required. Furthermore, hard particle suspensions, depending on the size of the particle, may tend not to be easily dispensed without clogging smaller gauge injection needles.

0013Furthermore, available methods of injecting bulking agents require the placement of a needle at a treatment region, for example, peri-urethrally or transperenially. Assisted by visual aids, the bulking agent is injected into a plurality of locations, causing the urethral lining to coapt. In cases where additional applications of bulking agent are required (<i>e.g</i>., when bulking agents are dissipated within the body), the newly added bulking agent may need to be injected at a higher pressure than the pressure at which the initial bulking agent was injected. The higher pressure requirements for subsequent injections may result from the effect of closing off the treatment region by the initial bulking agent, thereby creating backpressure when attempting to insert additional bulking agent(s). Typically, the bulking agent is injected at multiple locations to cause the uretheral lining to coapt with a higher opening pressure than the patient had prior to injection of the bulking agent.

0014Bulking agent delivery methods have attempted to address the issue of subsequent injection requirements. One method that has been employed is hydrodissection of tissue in the vicinity of the treatment region, thereby creating tissue voids designed to decrease the injection pressure required when adding additional bulking agent to the voids. Another method used to reduce injection pressures is the Urovive^™ device available from American Medical Systems. Urovive^™ utilizes a plurality of silicone balloons that are inserted into the treatment region, specifically, the periphery of the sphincter. The balloons are then filled with a hydrogel to effect tissue coaptation.

<u>Summary of the Invention</u>

0015The invention generally relates to an injectable bulking composition that does not degrade or dissipate in the body, has sufficiently low viscosity such that it is easily administered via injection, and will not migrate from the site of injection, thereby enabling the affected tissue to maintain the desired constriction without causing undesirable side effects as described in the claims.

0016In one aspect the invention relates to the use of polymeric particles to facilitate bulking in a treatment region of a mammal's body through injection of the particles into the treatment region. The particles are compliant enough to be delivered through a relatively small gauge injection device. Generally, the invention is employed in the treatment of diseases requiring sphincter bulking, <i>e.g</i>., for treating urinary or fecal incontinence; however, the bulking method described herein can also be used for soft tissue bulking for use during, for example, plastic surgery.

0017In another aspect the invention relates to a bulking agent for medical applications. The bulking agent includes a carrier and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier. The carrier aids the delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.

0018In yet another aspect, a method for bulking mammalian tissue which does not fall under the working of the claims is described. The method includes the steps of introducing a bulking agent to the mammalian tissue to coapt the mammalian tissue with the bulking agent. The bulking agent includes a carrier and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier. The carrier aids the delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.

0019In various embodiments of the foregoing aspects, the bulking agent comprises a volume. The volume could be, for example, from 1 ml to 30 ml, from 20 ml to 30 ml, or from 2 ml to 16 ml. In additional embodiments, the spherical polyvinyl alcohol particles are sized from 40 micron to 1500 microns in diameter, preferably from 150 micron to 1100 microns in diameter, and more preferably from 500 micron to 900 microns in diameter. Further, the spherical polyvinyl alcohol particles can comprise pores and/or bioreactive agents, such as drugs, proteins, genes, chemo-therapeutic agents, and growth factors. In other embodiments, the substantially spherical polyvinyl alcohol particles can be compressible and/or substantially dimensionally stable.

0020In additional embodiments, the carrier can be a water-based solution, such as saline solution. In addition, the carrier can include at least one of a lubricant, a biocompatible thickening agent, or a color. Furthermore, the bulking agent can be delivered through a needle and/or a catheter. In one embodiment, the bulking agent is delivered transuretherally. In addition, the bulking agent can be delivered while viewing the tissue to be bulked with a cytoscope.

0021In still another aspect, an apparatus for bulking mammalian tissue which does not fall under the working of the claims is described The apparatus includes a needle defining a lumen, an inflation device adapted to advance through the lumen of the needle, and a bulking agent insertable via the lumen of the needle. The needle is adapted to penetrate the mammalian tissue. The inflation device is disposed adjacent to the mammalian tissue after being advanced through the needle. The inflation device is inflatable and subsequently deflatable to create a void in the mammalian tissue. The bulking agent is inserted to fill at least partially the void in the tissue, the bulking agent coapting the mammalian tissue.

0022The inflation device can include a biocompatible balloon, and/or a color coating for visualization made from at least one of a silicone, an ethylene vinyl alcohol, a polypropylene, a latex rubber, a polyurethane, a polyester, a nylon, or a thermoplastic rubber. Additionally, the inflation device can have a shape selected from the group consisting of substantially round, oval, hemi spherical, spherical, or oblong. The needle may be sized from 16 gauge to 24 gauge, preferably from 18 gauge to 22 gauge.

0023In additional embodiments, the bulking agent comprises a plurality of polymeric particles and can be injected into the void by a syringe. In one embodiment, the bulking agent includes a carrier and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier. The carrier aids the delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked. The bulking agent can further include a color.

0024In yet another aspect, a a method for bulking mammalian tissue which does not fall under the working of the claims is described. The method includes the steps of inserting an inflation device within a portion of a mammal, inflating the inflation device to compress the mammalian tissue surrounding the inflated inflation device, thereby creating a void in the tissue, deflating the inflation device, removing the inflation device from the mammal, and providing a bulking agent to at least partially fill the void, the bulking agent coapting the mammalian tissue.

0025The method includes the steps of inserting a needle with a penetration device into the mammalian tissue, removing the penetration device while retaining the inserted needle, and advancing the inflation device through the needle. The needle can be sized from 16 gauge to 24 gauge, preferably 18 gauge to 22 gauge. The method can also include the step of viewing the tissue to be bulked with a cytoscope. The inflation device can include a biocompatible balloon, and/or a color coating for visualization made from at least one of a silicone, an ethylene vinyl alcohol, a polypropylene, a latex rubber, a polyurethane, a polyester, a nylon and a thermoplastic rubber. Additionally, the inflation device can have a shape selected from the group consisting of substantially round, oval, hemi spherical, spherical, or oblong.

0026In additional embodiments, the bulking agent comprises a plurality of polymeric particles and can be injected into the void by a syringe. In another embodiment, the substantially spherical polyvinyl alcohol particles are coated, embedded, or filled with a material that will aid the delivery of the particles to a site to be bulked. In one embodiment, the bulking agent includes a carrier and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier. The carrier aids the delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked. The bulking agent can further include a color.

0027These and other objects, along with advantages and features of the present invention, will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations.

<u>Brief Description of the Drawings</u>

0028In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which: <ul id="ul0001" list-style="bullet" compact="compact"><li><figref idref="f0001">FIG. 1</figref> depicts a side view of a tissue structure with an enlarged lumen surrounded by muscle tissue;</li><li><figref idref="f0001">FIG. 2</figref> depicts the tissue structure of <figref idref="f0001">FIG. 1</figref> immediately after a bulking agent in accordance with the invention has been injected around the enlarged lumen of the tissue;</li><li><figref idref="f0002">FIG. 3</figref> depicts the tissue structure of <figref idref="f0001">FIG. 1</figref> immediately after a bulking agent in accordance with the invention has been injected around the enlarged lumen of the tissue utilizing a cystoscope-aided injection method;</li><li>FIG. 4 is a schematic plan view of a needle assembly;</li><li>FIG. 5 is a schematic plan view of the needle assembly of FIG. 4 with the trocar/obtuator assembly being removed;</li><li>FIG. 6 is a schematic plan view of the needle assembly of FIG. 4 with a balloon assembly being inserted into the needle assembly;</li><li>FIG. 7 is a schematic plan view of the needle assembly of FIG. 4 with a syringe attached to the needle assembly for inflating the balloon;</li><li>FIG. 8 is a schematic plan view of the assembly of FIG. 7 with the syringe and balloon assembly being removed;</li><li>FIG. 9 is a schematic plan view of the assembly of FIG. 4 with another syringe attached to the needle assembly for injecting a bulking agent into tissue;</li><li>FIG. 10 is a pictorial representation of a method of creating a void within a patient's tissue by inserting and inflating a balloon; and</li><li>FIG. 11 is a pictorial representation of a method of filling the void within the patient's tissue with a bulking agent.</li></ul>

<u>Description</u>

0029Embodiments of the present invention are described below. The invention is not limited, however, to these embodiments. For example, various embodiments of the invention are described in terms of treating incontinence; however, embodiments of the invention may be used in other applications, such as cosmetic reconstruction.

0030Referring to <figref idref="f0001">FIG. 1</figref>, a tissue structure, more specifically a urethra/ureter 10, having a wall 20 and an enlarged lumen 30 surrounded by muscle tissue 40 is shown in side view. Before the enlarged lumen 30 is constricted with the bulking composition, a cystoscope 50 comprising a fiberoptic light transmitting element 60, a working channel 70 and a viewing element 80 encased in a sheath 90 may be inserted in the urethra/ureter 10 to a distance close to the enlarged lumen 30. The close distance is selected to allow a clear view of the enlarged lumen 30.

0031Referring to <figref idref="f0001">FIG. 2</figref>, the urethra/ureter 10 is shown immediately after a bulking agent in accordance with the invention has been injected around the enlarged lumen 30 of the tissue. Once the enlarged lumen 30 is readily in view, a hypodermic needle 100 is inserted through the tissue 40, preferably over the enlarged lumen 30, stopping near the wall 20 of the enlarged lumen 30. Thereafter, a bulking agent 110 including polymeric particles 120 is injected via the hypodermic needle 100 into the tissue 40 adjacent the wall 20. The result is a constricted region 130 located in the vicinity of the accumulation of the bulking agent 110.

0032Alternatively, referring to <figref idref="f0002">FIG. 3</figref>, the urethra/ureter 10 is shown immediately after the bulking agent 110 of the present invention has been injected around the enlarged lumen 30 of the tissue 40 utilizing a cystoscope 50 aided injection method. An elongate needle 140 may be inserted through the working channel 70 into the urethra/ureter 10 and the surrounding tissue 40 and the injection can be completed operating solely through the cystoscope 50. This is generally the preferred method of operation on male patients for the area surrounding the urethra/ureter and is the preferred method for female patients for the area surrounding the ureter.

0033Furthermore, the present invention relates to a bulking agent including spherical polyvinyl alcohol particles used to facilitate bulking in a region of the human body through injection of the particles into the treatment region. The particles are compliant enough to be delivered through a substantially small gauge injection device. In one embodiment, the particles are 50% compressible. This is accomplished through the use of particles that are adapted to compress as they pass through the small gauge injection device. In one embodiment, a 16 to 24 gauge needle is used to dispense the bulking composition without clogging. In other applications, other size needles may be preferred, for example 18-22 gauge.

0034Filling the space surrounding the urethra/ureter allows the sphincter to be more readily coapted by the patient to maintain continence. Generally, the present invention is employed in the treatment of diseases requiring bulking, <i>e.g</i>., urinary or fecal incontinence. Some examples of conditions that can be treated by way of the present invention include urinary incontinence, vesicourethral reflux, fecal incontinence and intrinsic sphincter deficiency or ISD. However, the bulking method described herein can also be used for soft tissue bulking for use during, for example, plastic surgery.

0035In greater detail, the method of providing a bulking agent to the human body includes using polymeric particles, such as polyvinyl alcohol, as a bulking agent and injecting the particles into the treatment region of the human body. An advantage of the present invention is that the particles are substantially non-biodegradable, thereby virtually eliminating the need for replenishing the particles to maintain efficacy. A further advantage of the present invention is that the spherical size and shape of the particles allows for close packing of the particles in the treatment space.

0036In one embodiment, the particles are made of a water and polyvinyl alcohol mixture. For a description of particles contemplated for use with the present invention, see U. S. Patent <patcit id="pcit0009" dnum="US2004076582A"><text>US 2004 076582</text></patcit>, <patcit id="pcit0010" dnum="US2003233150A"><text>US 2003 233 150</text></patcit>, <patcit id="pcit0011" dnum="US2003203985A"><text>US 2003 203985</text></patcit>, <patcit id="pcit0012" dnum="US2003233150A"><text>US 2003 233 150</text></patcit>. Generally, water, polyvinyl alcohol, and alginate are combined and pumped through a nozzle under pressure, generating substantially spherically-shaped droplets. The substantially spherically-shaped droplets encounter a solution that promotes cross-linking of the polyvinyl alcohol. Subsequently, the alginate is removed from the outer surface. The result is a substantially spherically-shaped particle that is substantially all polyvinyl alcohol.

0037To facilitate other treatments, dosages of bio-active agents can be added to the particles. For example, substances, such as drugs, growth factors, proteins, genes, and chemo-therapeutic agents can be added to the particles to enhance localized treatments while still providing significant bulking benefits. The particles themselves are substantially inert in that they do not tend to react with body fluids and/or tissue. For example, many other types of bulking particles swell in use. In contrast thereto, the substantially spherical polyvinyl alcohol particles are substantially dimensionally stable. Some tissue growth on, near, or around the particle surface may occur, but no biological interaction between the tissue and the particles is expected.

0038In one embodiment, the particles are substantially solid. In a particular embodiment, the particles are substantially spherically-shaped and are sized in a range of 40 microns to 1500 microns in diameter, preferably 150 microns to 1100 microns in diameter, and more preferably 500 microns to 900 microns in diameter. The size of the particles chosen for a particular application will be determined by a number of factors. Smaller particles are easier to inject with a smaller gauge size needle; however, embolization due to migration of the particles is a concern with the smaller particle sizes. The size of the particles used in a particular procedure will include consideration of the procedure employed, disease progression, the degree of degradation of the affected region, patient size, the disposition of the patient, and the preferences and techniques of the doctor performing the procedure. Similarly, such factors must be considered when determining the proper volume of bulking agent to inject into a patient. In one embodiment of the invention, the volume of bulking composition is 1 ml to 30 ml, and preferably 20 ml to 30 ml. In another embodiment, the volume of bulking composition injected into a patient is 2 ml to 16 ml. However, these amounts can vary significantly based on the doctor's determination as to when the target region is sufficiently bulked up.

0039To vary compressibility, provide for absorption of medications, or for the purpose of incorporating the particles into the surrounding tissue, the porosity of the particles may be modified. These effects, if desired, can be enhanced by increasing pore size. For example, tissue in-growth can be encouraged by increasing pore size. Preferably, pore sizes are within a range of 4 microns to 5 microns up to 30 microns to 50 microns. In one embodiment, the pores cover up to 80% of the surface area of the particle.

0040In one embodiment, the bulking particles are injected through a needle. In other embodiments, a cystoscope is used to allow for viewing the injection area. The bulking particles can be supplemented with a contrast agent to enhance their appearance as an aid to the doctor performing the procedure. Other methods of visual enhancement to assist in viewing of the bulking agent can also be employed. Injection of the particles can also be accomplished transuretherally by, for example, using a catheter.

0041The method of providing the bulking agent to the human body further includes mixing the bulking particles with a carrier such that the particles are suspended in the carrier, and then injecting the particles-carrier mix into the treatment portion of the human body. The carrier serves as a lubricant for the particles thereby increasing the ease with which the particles move into the body. In another embodiment, the carrier is a saline solution. In other embodiments bio-compatible thickening agents such as alginate, beta-glucan, glycerin, cellulose, or collagen are added to the carrier or serve as the carrier themselves to modify the viscosity of the carrier. By varying the carrier viscosity, proper disbursement of the bulking particles can be accomplished; however, carriers must not be so viscous that their passage through an injection device is inhibited. In yet another embodiment, the carrier may be bio-active, that is the carrier includes an anti-microbial agent, or the like.

0042The following method may be used to dilate tissue within a treatment tissue region to facilitate injection of the bulking agent. The method includes: inserting a needle with a penetration device (<i>e.g</i>., a taper point obtuator or trocar) into the treatment region (<i>e.g</i>., the sphincter region) (FIG. 4); removing the penetration device while retaining the inserted needle (FIG. 5); advancing a balloon through the needle (FIG. 6); inflating the balloon, thereby creating a void in the treatment region (FIG. 7); deflating and removing the balloon from the treatment region (FIG. 8); affixing a syringe with a bulking agent to the needle and injecting the bulking agent into the tissue void (FIG. 9). This procedure can be repeated as necessary in order to maximize the effectiveness of the bulking agent and to achieve the desired results.

0043The method and apparatus for carrying out the method in a method to treat urinary incontinence by bulking the urethral tissue is described generally with reference to FIGS. 4-11. A needle 400, such as a blunt-end hypotube or hypodermic needle having a first end and a second end, is adapted to accept a penetration device 404, such as a taper point obtuator or a trocar, at the first end of the needle 400 (FIG. 4). The needle 400 may range in size from about 18 gauge to about 22 gauge, and preferably about 20 gauge to about 22 gauge. The penetration device 404 is attached to the needle 400 to enable penetration of the needle 400 into the tissue. The penetration device 404 may be adapted to the needle 400 by way of a luer hub or fitting, and in one embodiment, a male luer hub is used. The needle 400 is inserted with the penetration device 404 into the treatment region 420 (<i>e.g</i>., the sphincter region)(FIG. 10) to the desired depth. The desired penetration depth can be determined by striping 406 located on the penetration device 404. The amount of penetration of the penetration device 404 ranges from about 2 cm to about 2.5 cm (FIG. 4). The amount of tissue penetration of the needle 400 ranges from about .5 cm to about 1 cm beyond the tissue line 407 (FIG. 5). The penetration device 404 is removed while retaining the inserted needle 400 (FIG. 6).

0044A luer hub 402 or fitting, or a female luer hub, may be adapted to the second end of the needle 400, to which a syringe 412, 418 (FIGS. 7-9) is adapted. Referring to FIG. 4, the luer hub 402 is depicted in its locked position, and in FIG. 5 the luer hub 402 is depicted in its unlocked position. In the locked position, the luer hub 402 can be positioned for inflating the balloon 408 or injecting a bulking agent 416. In the unlocked position, the luer hub 402 can be positioned for accepting the balloon 408 for insertion or for removal of the balloon 408 after dilation.

0045The balloon 408 is adapted to advance through a lumen of the needle 400, and an adapter on the balloon 408 provides a means to lock the balloon 408 to the luer hub 402, which in turn adapts to the syringe 412 (FIG. 6). The balloon 408 may have no tip or, alternatively, the balloon 408 may have a small stump appendage, which may remain from processing of the balloon. The balloon 408 is affixed to an end of a plastic tube 410 (FIG. 6). The tip for the balloon 408 is integral with a shaft. Balloon 408 may include at least one fill and/or evacuation port.

0046The balloon may be a colored balloon (e.g., blue) to facilitate remote visualization of the procedure and proper placement of the balloon. Alternatively, the balloon could be clear to transparent and the inflation media could be colored, for example, a colored saline solution. The balloon may be semi-compliant or non-compliant. The balloon may be manufactured from any suitable material, for example, a polymer. Some examples of suitable balloon materials include: silicone, ethylene vinyl acetate (EVA), polypropylene, latex rubber, polyurethane, polyester, nylon and thermoplastic rubber. The balloon is inflated to, for example, about 3 cm to about 5 cm in diameter. The balloon may assume a variety of shapes. Some shapes that may be considered, depending upon the attendant requirements of the procedure, include substantially round, oval, hemi spherical, and oblong. The length of the balloon may vary depending upon the procedure. The inflated balloon may have a length in the range of, for example, about 3 cm to about 10 cm. Other balloon configurations may be employed, and the types and methods used to employ the most suitable balloon configurations for a particular application of this invention will be obvious to those skilled in the art.

0047The balloon 408 is then inflated using an inflation device, such as the syringe 412, creating a void in the treatment region (FIGS. 7 and 8). The balloon may be colored (i.e. blue) to aid in visibility through the tissue. As the balloon 408 expands, the balloon 408 becomes visible to aid in proper balloon placement. For example, the expanding balloon 408 may become visible under the urethra as it thins. The balloon 408 inflates to a volume of about 1cc to about 1.5 cc, although such volumes may vary depending upon many factors inherent in the characteristics of the particular application, some of which were discussed previously. Saline may be used to inflate the balloon 408. About 3 cc of saline is placed in the syringe 412 and injected into the balloon 408 for inflation.

0048The balloon 408 is then deflated and removed from the treatment region, resulting in a tissue void 414 where the inflated balloon 408 previously resided (FIGS. 8 and 10). The balloon 408 is removable through the lumen of the needle 400. A plastic tube or other tip 410 is used to aid in removal of the balloon 408.

0049A syringe or other injection device 418 containing the bulking agent 416 is then affixed to the needle 400 by way of the luer hub 402. The plunger of the syringe 418 is then depressed, thereby injecting the bulking agent 416 into the tissue void 414 (FIGS. 9 and 11).

0050While the invention has been shown and described with reference to specific embodiments, it should be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the invention.

0051Having thus described certain embodiments of the present invention, various alterations, modifications, and improvements will be apparent to those of ordinary skill. Such alterations, modifications, and improvements are within the scope of the invention, and the foregoing description of certain embodiments is not exhaustive or limiting.