Abstract:
Methods for decreasing the size and/or changing the shape of pelvic tissues. Energy, preferably radio frequency or laser energy, may be applied to endopelvic fascia or other subcutaneous tissue transcutaneously, through one or more incisions in skin, or directly to the desired subcutaneous tissue after a strip of mucosa or skin has been removed. Such an application of energy may cause the subcutaneous tissue to shrink, thereby bringing the mucosa or skin edges closer together while minimizing damage to deep nerves and other surrounding tissues. Such manipulation of the layers of the skin may be utilized to decrease the size or change the shape of numerous anatomical structures and may also serve to alleviate the symptoms of urinary incontinence, dyspareunia, or chronic pelvic pain. The method steps of the present invention may further provide for the beneficial pretreatment of a tissue site prior to stem cell implantation.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of provisional patent application Ser. No. 61/077,348, filed with the USPTO on Jul. 1, 2008, which is herein incorporated by reference in its entirety. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISK 
       [0003]    Not applicable. 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    The present invention generally relates to surgical methods, more specifically, the present invention relates to changing the shape and/or size of tissues and structures within the pelvic region including but not limited to the vagina, labia, prepuce, perineum, and other tissues. 
         [0006]    2. Background Art 
         [0007]    Many women are unhappy with the size, shape, and/or contour of the vagina or labia. This may be secondary to changes that occur with childbirth, vaginal or pelvic surgery, and/or aging. Sometimes the size, shape, and/or contour abnormality may be congenital. This enlargement and/or unsatisfactory shape or contour may lead to sexual dysfunction which may be anatomic or psychological in nature. Until recently, vaginal reconstruction and vulvar surgery has been reserved for the treatment of neoplasia and prolapse. As women have become more outspoken about their dissatisfaction with their genitalia, surgeons have begun to offer those patients surgical corrections typically utilized for the treatment of neoplasia and prolapse. Although these surgeries may alter the size and shape of the vagina and labia, they may often compromise sexual function or create less than optimal aesthetic results. 
         [0008]    Presently utilized surgeries injure tissue, deform anatomy, or remove vital tissue. The sexual dysfunction created by such surgeries may be secondary to stenosis of the vagina, shortening of the vagina, injury to muscles or nerves leading to pain or anesthesia, injury of the Graffenberg Spot, removal of the Graffenberg spot, or poor aesthetic appearance leading to psychological sexual dysfunction. 
         [0009]    Injuries to the supporting structures of the vagina and surrounding tissues may also cause urinary incontinence. Present treatments for urinary incontinence do not restore normal anatomic structure. Such treatments either create new support with donor or synthetic tissue or distort anatomy to create a compensatory mechanism for managing the defect. The present invention provides for methods that may be used to change the size or shape of pelvic tissues, wherein such methods may be used for aesthetic procedures, treatments for urinary incontinence, and the like. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    In accordance with one embodiment, a method for reshaping pelvic treatment tissue, wherein the method comprises the steps of incising a first tissue layer, removing at least a portion of the first tissue layer, and applying an energy to an underlying tissue layer for initiating shrinkage of the underlying tissue layer. 
         [0011]    Another aspect of the present invention provides for a method for reshaping pelvic tissue via transmucosal energy delivery, wherein the method comprises the steps of providing a probe capable of emitting an energy source from a distal end of the probe, inserting the probe into the pelvic tissue, activating the energy source, translating the distal end of the probe across the pelvic tissue, wherein the distal end of the probe is kept in continuous motion, deactivating the energy source, and removing the distal end of the probe from the pelvic tissue. 
         [0012]    An additional aspect of the present invention provides for a method for reshaping tissue, the method comprises the steps of providing a device comprising a cannula needle and a laser fiber coaxially disposed within the cannula needle, wherein the laser fiber may be disposed in a retracted position with a distal end of the laser fiber disposed within the distal tip of the cannula needle and an extended position wherein the distal end of the laser fiber protrudes beyond the distal tip of the cannula needle, advancing the cannula needle into the tissue while the laser fiber is in the retracted position, disposing the laser fiber in the extended position, activating the laser fiber for delivery of laser energy to the tissue, withdrawing the cannula needle along the pathway of the step of advancement providing for delivery of the laser energy along the pathway of the step of advancement, and deactivating the laser fiber. 
         [0013]    Accordingly, it is the object of the present invention to provide a method to contour one or more pelvic tissues without leading to loss of function or poor aesthetic results. Additionally, one or more of the embodiments of the present invention may also be used to treat urinary incontinence. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1A  depicts a schematic diagram of one step in a first embodiment of the present invention. 
           [0015]      FIG. 1B  depicts a schematic diagram of another step in the first embodiment of the present invention. 
           [0016]      FIG. 1C  depicts a schematic diagram of still another step in the first embodiment of the present invention. 
           [0017]      FIG. 1D  depicts a schematic diagram of yet another step in the first embodiment of the present invention. 
           [0018]      FIG. 2A  depicts a schematic diagram of one step in a second embodiment of the present invention. 
           [0019]      FIG. 2B  depicts a schematic diagram of another step in the second embodiment of the present invention. 
           [0020]      FIG. 2C  depicts a schematic diagram of still another step in the second embodiment of the present invention. 
           [0021]      FIG. 3A  depicts a schematic diagram of one step in a third embodiment of the present invention. 
           [0022]      FIG. 3B  depicts a schematic diagram of another step in the third embodiment of the present invention. 
           [0023]      FIG. 3C  depicts a schematic diagram of still another step in the third embodiment of the present invention. 
           [0024]      FIG. 4A  depicts a schematic diagram of a treatment phase of a fourth embodiment of the present invention. 
           [0025]      FIG. 4B  depicts a schematic diagram of a post-treatment phase of the fourth embodiment of the present invention. 
           [0026]      FIG. 5A  depicts a side view of one embodiment of a laser energy source of the present invention. 
           [0027]      FIG. 5B  depicts a magnified side view of the embodiment of the laser energy source of the present invention depicted in  FIG. 5A . 
           [0028]      FIG. 6A  depicts a schematic diagram of a treatment phase of a fifth embodiment of the present invention. 
           [0029]      FIG. 6B  depicts a schematic diagram of a post-treatment phase of the fifth embodiment of the present invention. 
           [0030]      FIG. 7  depicts a side view of another embodiment of a laser energy source of the present invention comprising a laser scalpel. 
           [0031]      FIG. 8  depicts a side view of another embodiment of a laser energy source of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]    The scope and breadth of the present inventive disclosure is applicable across a wide variety of procedures, tissues and anatomical structures. Although the following detailed description contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following preferred embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention. 
         [0033]    A first embodiment, depicted in  FIGS. 1A-1D , may provide for protection of the Graffenberg Spot (G-Spot). In this embodiment, the vaginal mucosa of the G-Spot  100  may be left intact. At least one incision  110  of any known shape, preferably triangular-shaped, may be made around the G-Spot  100 , as shown in  FIG. 1A . The at least one incision  110  may be carried through the thickness of the vaginal mucosa  120 . The at least one incision  110  may spare the endopelvic fascia  130 . The at least one incision  110  may assume any known shape thereby defining the shape of an island  140  of tissue. In a preferred embodiment, as shown in  FIGS. 1A-1D , a triangular-shaped island  140  of mucosa  120  may be created by the at least one incision  110 . A strip  150  of mucosa  120  may be removed from the circumference of the island  140  to expose a channel  160  of endopelvic fascia  130 , as shown in  FIG. 1B  and  FIG. 1C . The diameter of this channel  160  will determine the final shape and/or size of the vagina. As shown in  FIG. 1D , radio frequency (RF) energy may then be applied to shrink the channel  160  of endopelvic fascia  130  and close the gap between the mucosal  120  edges as shown by the relative movement of point A and point B. The limited penetration of RF energy spares the underlying nerve structure and improves the thickness of peri-island fascia. The mucosal  120  edges may be left “as is”, approximated with sutures or glue, or closed by any other manner known within the art. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0034]    A second embodiment, depicted in  FIGS. 2A-2C , may provide for vaginal shaping without removal of fascia. In this embodiment, as shown in  FIG. 2A , strips  250  of vaginal mucosa layer  220  may be removed while sparing the underlying endopelvic fascia  230  and nerve injury (see  FIG. 2B ). Rather than pulling the mucosal  220  edges together and creating a submucosal deformity, RF energy may be applied to shrink the endopelvic fascia  230  and bring the mucosal  220  edges closer together, as shown by the relative movement of point A and point B in  FIGS. 2B and 2C . The limited penetration of RF energy acts to spare the underlying nerve structure and improves the thickness of underlying tissue. The mucosal  220  edges may be left “as is”, approximated with sutures or glue, or closed by any other manner known within the art. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0035]    A third embodiment, depicted in  FIGS. 3A-3C , may provide for vaginal shaping without removal of mucosa. As shown in  FIG. 3A , one or more incisions  310  may be made in the mucosa  320 . The endopelvic fascia  330  or other submucosal tissue may be left attached to the mucosa  320 . As shown in  FIG. 3B , RF energy may be applied to the endopelvic fascia  330  or other submucosal tissue exposed between the one or more incision  310  margins. Such an application of energy will cause shrinkage of such endopelvic fascia  330  tissue with proportional contraction of the overlying mucosa  320  and spare the deep nerves and subfascial or subcutaneous tissue  335 . Any such endopelvic fascia  330  that is left exposed (as expressly disclosed in all embodiments) may be treated with RF energy. In this manner, the mucosal  320  edges closer together and provide a new contour or shape to the mucosa  320 , as shown in  FIG. 3C , as the mucosal  320  edges are motivated against each other due to the shrinkage of the endopelvic fascia  330 . The mucosal  320  edges may be left “as is”, approximated with sutures or glue, or closed by any other manner known within the art. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0036]    A fourth embodiment may provide for contouring of the prepuce. As expressly disclosed in the method steps above, one or more incisions may be created around the prepuce and RF energy may thereafter be applied to the underlying fascia. Such an embodiment is similar to that shown in  FIGS. 3A-3C  and analogous steps may be applied to the prepuce. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0037]    A fifth embodiment may provide for contouring of the labia minora. As expressly disclosed in the method steps above, one or more incision may be made in the labia minora. The subcutaneous tissue may not be separated from the epithelium. RF energy may then be applied to the subcutaneous tissue. The shrinkage of the subcutaneous tissue and/or fascia shall contour the labia. Such an embodiment is similar to that shown in  FIGS. 3A-3C  and analogous steps may be applied to the labia minora. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0038]    A sixth embodiment may provide for contouring of the perineum. As expressly disclosed in the method steps above, a portion of perineum skin may be removed sparing the underlying fascia and nerves. RF energy may then be applied to the fascia and other subcutaneous tissue. The shrinkage of the subcutaneous tissue and/or fascia will bring the epithelial edges closer together. The edges may be left “as is”, approximated with sutures or glue, or closed by any other manner known within the art. Such an embodiment is similar to that shown in  FIGS. 2A-2C  and analogous steps may be applied to the perineum. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0039]    A seventh embodiment may provide for contouring of the labia majora. As expressly disclosed in the method steps above, one or more incisions may be made in the labia majora. The subcutaneous tissue may not be separated from the epithelium. RF energy may then be applied to the subcutaneous tissue. The shrinkage of the subcutaneous tissue and/or fascia shall contour the labia. Such an embodiment is similar to that shown in  FIGS. 3A-3C  and analogous steps may be applied to the labia majora. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0040]    As an alternative or addition, a portion of labial skin may be removed sparing the underlying fascia and nerves. RF energy may then be applied to the subcutaneous tissue and/or fascia. The shrinkage of the subcutaneous tissue and/or fascia will bring the labial skin edges closer together. The edges may be left “as is”, approximated with sutures or glue, or closed by any other manner known within the art. Such an embodiment is similar to that shown in  FIGS. 2A-2C  and analogous steps may be applied to the labial skin. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0041]    An eighth embodiment, depicted in  FIG. 4A  and  FIG. 4B , may provide for transmucosal and transcutaneous contouring. As shown in  FIG. 4A , pelvic tissues including but not limited to the vaginal mucosa, labia, prepuce, and/or perineum may be treated by the transcutaneous application of RF energy. In such an embodiment, RF energy may be applied to the tissue  430  (e.g. dermis, subcutaneous tissue, and/or fascia) below the mucosa or skin  420  without an incision being made or portions of the mucosa or skin  420  being removed. Application of such RF energy may preferably be via a needle, probe, or any other non-invasive instrument  440  known within the art.  FIG. 4A  depicts one embodiment performing the step of application of energy from one or more side ports  450  of a non-invasive means  440 . As shown in  FIG. 4B , the resultant shrinkage and changes to underlying tissue  430  shall shape the overlying structures as needed. Although RF is the preferred energy source, any other types of energy known within the art including but not limited to laser energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used. 
         [0042]    Another effective embodiment, similar to that shown in  FIGS. 4A and 4B , may involve the use of a cannula needle and laser fiber.  FIG. 5A  depicts one potential and preferred embodiment of such a cannula needle and laser fiber device  500 . In one embodiment, the device  500  may comprise an outer housing  501  secured to a cannula needle  502  having a distal portion  503 . The distal portion  503  may comprise a distal tip  504  from which a laser fiber  505  may be extended and retracted.  FIG. 5B  illustrates a close-up view of the laser fiber  505  disposed in an extended state and protruding beyond the distal tip  504  of the cannula needle  502 . The device  500  may comprise additional optional features to facilitate use, such optional features may include but are not limited to male/female Luer locks  506  for attaching the cannula needle to the outer housing  501 , and a compression spring  507 , clocking pin  508 , spring cap  509 , slide body  511 , and slide limiter  512  providing for modes of extending and retracting the laser fiber  505  relative to the distal tip  504  of the cannula needle  502 . The laser fiber  505  may extend from the proximal end of the device  500  to a laser source  513  through a fiber locking screw  514 . 
         [0043]    In use, the laser fiber  505  may be advanced to the distal portion  503  of the cannula needle  502  without extending beyond the distal tip  504  and thereafter the cannula needle  502  may be inserted through a small puncture and advanced to the desired pelvic treatment area. In one embodiment, the cannula needle  502  may then be slightly retracted disposing the distal end of the laser fiber  505  just beyond the distal tip  504  of the cannula needle  502 . The laser fiber  505  may then be activated to deliver laser energy along the path of the cannula needle&#39;s  502  withdrawal. This delivery of energy may be supplied either continuously or in a pulsed fashion. The energy being delivered through the distal end of the laser fiber  505  may also be altered in power, pulse width, and/or rest time in order to provide differential treatment along the path of movement of the distal end of the laser fiber  505 . Application of energy in this manner may result in a shaping or molding of the tissue rather than a uniform contraction. One example of use of such a device  500  and/or method may be in the vagina where distal application of a greater magnitude of energy will help to create the normal taper of the vagina. In a preferred embodiment, energy may be applied in the form of a 980 nm-1064 nm wavelength laser to be effective. However, other laser wavelengths and other forms of energy may replace a highly preferred 980 nm laser within the scope of the present invention. In a preferred embodiment, 810-1064 nm will be delivered at no less than 4 watts and no more than 25 watts. In the preferred embodiment pulse time will be no less than 0.1 second and no more than 2 seconds continuous energy. However, in circumstances where the cannula needle  502  is kept in continuous motion (pulled out without stopping), the pulse may be equal to the length of time required to treat the entire cannula needle removal or insertion tract with the cannula needle  502  moving no slower than 0.25 cm per second. 
         [0044]    In one variation of the preferred embodiment, the energy will be increased or decreased as the distal end of the laser fiber  505  approaches the opening of the vagina. If the vagina needs more tightening near the opening, the energy may be increased at such a location. If the apex of the vagina needs more shrinking relative to the opening of the vagina, the energy will be decreased as the distal end of the laser fiber  505  approaches the vaginal opening. Preferably these power and/or pulse adjustments may be preset in the laser device  500 . In one embodiment the laser power and/or pulse width will be serially increased or decreased each time the surgeon deactivates and then reactivates the laser (e.g. releases and steps back down on the laser pedal). Four typical presets may start with the laser power at 12, 14, 17, and 19 watts and increase by 1 watt each time the surgeon reactivates the laser. The maximum increase is typically set between 5 and 10 watts. Once the maximum is reached, there may be no change in power with subsequent activations. Additionally, while the disclosure describes a preferred method of energy application during withdrawal of the device  500 , energy may additionally or alternatively be applied or delivered during advancement of the device  500  through the pelvic treatment tissue. Although the present embodiment utilizes a laser as the preferred energy source, any other types of energy known within the art including but not limited to RF energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery may be used with such respective structures replacing the laser fiber  505 . 
         [0045]    In a preferred embodiment of the device  500 , forward pressure or advancement of the cannula needle  502  may cause the laser fiber  505  to move back against a spring  507 . Similarly, backward movement or withdrawal of the cannula needle  502  may cause the laser fiber  505  to be advanced or extended beyond the distal tip  504  of the cannula needle  502  by the biasing force of the spring  507 . In an alternate embodiment of the device  500 , the laser fiber  505  may require manual advancement against the biasing force of a spring  507  to advance or extend the distal end of the laser fiber  505  beyond the distal tip  504  of the cannula needle  502 . 
         [0046]    A ninth embodiment, depicted in  FIG. 6A  and  FIG. 6B , may provide for applying minimally destructive energy directly or indirectly to the tissues  620  of the vagina and/or vulva, which may be followed by the implantation of stem cells  670 . Such a “pretreatment” of energy may take the form of RF energy, microwave energy, laser energy, chemical energy, monopolar or bipolar electrosurgery, or any other surgical energy sources known within the art. As shown in  FIG. 6A , the application of such energy may be delivered with or without an incision. Application of such energy may preferably be via a needle, probe, or any other non-invasive means  640  known within the art having application elements  650  such as ports, conduits, fibers, and the like respective to the specific type of energy source used. The pretreatment of energy creates an environment favorable to stem cells  670 . Chemical pretreatment, via any known chemical agent(s), may also provide for minimal destruction and/or minimal injury. As shown in  FIG. 6B , following pretreatment with an energy source, stem cells  670  may be implanted within the pelvic treatment tissue through exit ports  660  of the non-invasive instrument  640 . Such implantation may be performed with a needle, via an incision, or any other means known within the art. The respective steps of the energy pretreatment and the stem cell implantation treatment may be performed in either one stage or two separate stages and by one device or two separate devices for each step. 
         [0047]    A tenth embodiment may provide for a method of treating periurethral tissue. All method steps disclosed herein for decreasing the size or changing the shape of anatomical tissue, most particularly the ninth embodiment above, may further be used in the treatment of periurethral tissue. Such treatments may improve the symptoms commonly associated with urinary incontinence. 
         [0048]    In an eleventh embodiment, the shaping or resizing of the vulva or other pelvic structure may be facilitated by the delivery of energy through a mechanical cutting instrument. One embodiment of such a device is depicted in  FIG. 7  and may consist of a glass scalpel  700  or any other similar instrument known within the art. Such a glass scalpel  700  or equivalent device may be used to create a mechanical cut or incision and simultaneously deliver laser energy for coagulation and tissue treatment (e.g. shrinkage) purposes. In a preferred embodiment, CO 2  laser energy may be delivered by a laser fiber  705  to the scalpel cutting blade  715  in the range of 2 watts to 15 watts of continuous power. In a preferred embodiment, the energy will be delivered to the blade as close to TEM 00  as possible. 
         [0049]    In a twelfth embodiment, as generally depicted in  FIG. 8 , low level laser energy may be delivered transmucosally to the vagina or other pelvic tissue. The use of such energy has been shown to increase cytochrome c oxidase production and reverse the effects of cellular inhibitors of respiration. Such steps may lead to healing of tissue, reshaping of tissue, and creation of a fertile environment for the potential implantation of stem cells. In one embodiment, the low level laser energy may be delivered via a device  800  comprising a laser fiber  805  disposed inside a vaginal probe  801 . The probe  801  may be moved in and out of the vagina in order to deliver the energy to the appropriate surrounding tissues. The probe  801  may be made of glass, plastic, or any other material known within the art and may have a bulbous or “roller ball” type distal end  816 . Such a “roller ball” structure may allow for the bulb to illuminate  825  in a uniform 360 degree pattern or as close to such a pattern as possible. Multiple treatments may be necessary to achieve the desired effect. While 980 nm and 808 nm wavelength lasers are the preferred energy sources, other wavelengths, other energy sources including but not limited to RF energy, microwave energy, chemical energy, and monopolar or bipolar electrosurgery, and any combinations thereof may be used within the scope of the present invention. 
         [0050]    In one method of use, the probe  801  may be inserted into the vagina until the distal end  816  reaches the vaginal apex. The laser fiber  805  may be in standby mode until the distal end  816  of the probe  801  is at least introduced into the vagina. Once the distal end  816  reaches the apex of the vagina, the laser fiber  805  may be put in ready mode. Once in ready mode, the laser  805  may be activated by stepping on a foot pedal. The user may step on the foot pedal once the distal tip  816  reaches the vaginal apex and then stay on the foot pedal while moving the probe  801  and distal end  816  in an “in and out” motion. In one embodiment, the probe  801  may be kept in constant motion for at least five minutes and reaches a total output of approximately 4200 J. The user may then release the foot pedal to place the laser  805  back in standby mode prior to the extraction of the probe  801  and distal end  816  from the vagina. 
         [0051]    While the above description contains much specificity, these should not be construed as limitations on the scope of any embodiment, but as exemplifications of the presently preferred embodiments thereof. Many other ramifications and variations are possible within the teachings of the various embodiments. 
         [0052]    Thus the scope of the invention should be determined by the appended claims and their legal equivalents, and not by the specific examples given.