Abstract:
A device for degenerating a fibroid comprises a pincher mechanism capable of pinching a uterine artery with a force sufficient to substantially obstruct blood flow therethrough. The pincher mechanism is sized and shaped so as to access the uterine artery through a wall of a patients vaginal vault. In a method for degenerating a uterine fibroid, the aforesaid pincher mechanism is, closed about a uterine artery so as to block the flow of blood therethrough. The pincher mechanism is maintained in the closed position for a period of time-necessary to degrade or kill the fibroid. After such time has, passed, the pincher mechanism is opened, removed from around the artery such that normal blood flow resumes.

Description:
FIELD OF THE INVENTION 
       [0001]    This invention relates, generally, to the treatment of uterine fibroids by obstruction of the uterine arteries. More specifically, it relates to the use of mechanical instruments to block the flow of blood through the arteries. 
       BACKGROUND OF THE INVENTION 
       [0002]    Uterine leiomyomas (i.e., fibroids) are extremely common benign tumors, which are located primarily within the uterine muscle (i.e., intramural fibroids), the uterine cavity (i.e., submucosal fibroids) or on the serosal surface of the uterus. Such fibroids occur in approximately 20% to 30% of women older than 30 years of age. Medical treatment is usually sought when the fibroids are associated with menorrhagia, pelvic pain or urinary symptoms, or when they are suspected to be the cause of infertility. Treatment options include medical therapy and various types of surgical intervention. 
         [0003]    Hysterectomy: is considered to be the definitive surgical treatment for those women who no longer wish to maintain their fertility. Though effective, this method has a number of undesirable characteristics. First is the mortality rate for this procedure, which is approximately 30 times as great as the mortality rate for women who have not had hysterectomies. Further adverse effects of hysterectomies include damage to adjacent organs, including removal, of the ovaries, lengthy hospital stays and periods of recovery, and an increased likelihood of cardiac arrest, decreased sexual pleasure, and increases in depression or anxiety. Surgical removal of fibroids without hysterectomy, by any surgical method, presents a risk of recurrence of fibroids or, more often, failure to observe existing fibroids or misidentification of the fibroids that are causing adverse symptoms. 
         [0004]    It has been established that fibroids can be treated by non-surgical therapies involving the temporary obstruction of the blood flow within the arteries transporting blood into the uterus. One example of such a treatment is uterine artery embolization (UAE). UAE involves the injection of tiny particles of polyvinyl alcohol (PVA) through blood vessels to block the arteries supplying blood to the fibroids. This blockage of the blood supply causes degeneration of the fibroids leading to their death. However, UAE is performed by radiologists who, typically, are unfamiliar with, practices of gynecological care. As of now, UAE&#39;s are performed in radiology suites, which have high installation and operational costs and which, therefore, are generally restricted to major medical centers. Also, however UAE is practiced, the movement of the PVA particles is flow-directed and their distribution is not limited to the arteries that supply the fibroids, but may affect blood flow to other areas of the uterine tissue or to the ovaries. 
         [0005]    There exists a need for devices and methods that can be used to temporarily obstruct the flow of blood to fibroids. The devices should be relatively inexpensive and simple to apply, and should allow the physician to control the degree by which blood flow is reduced. Various devices and methods for obstructing the uterine arteries have been disclosed in the prior art. 
         [0006]    U.S. Pat. No. 6,254,601 discloses methods for penetrating the wall of the vaginal vault near the uterine artery with devices that sense the locations of the anatomical structures and occlude the uterine artery. A number of methods and devices are disclosed. These disclosures are also presented in U.S. Pat. Nos. 6,602,251 and 6,764,488. 
         [0007]    U.S. Pat. No. 6,550,482 discloses a clamp for temporarily obstructing the uterine artery. The clamp stretches the wall of the vaginal vault around the artery and applies pressure to stop blood flow. 
         [0008]    U.S. Patent Publication No. 2002/0165579 discloses a compression device for distending the wall of the vaginal vault and thus, compressing the uterine artery. Doppler ultrasound techniques are used to locate the uterine artery and sense when blood flow has stopped. 
         [0009]    U.S. Patent Publication No. 2002/0183771 discloses a compression device that clamps around the uterine artery and, the vaginal wall to stop blood flow. 
         [0010]    U.S. Patent Publication No. 2002/0188306 discloses a forceps-type clamp that is inserted into the vagina and clamps around the uterine artery and; the vaginal wall. Ultrasound sensors are placed on the ends of the clamp to allow location of the uterine artery and sense blood flow. Similar forceps-type clamps are described in a number of other references. 
         [0011]    U.S. Patent Publication No. 2002/0124853 is directed to a method of temporarily obstructing blood flow through the uterine artery for a set period of time, then re-establishing blood flow through the artery. A forceps-type clamp is used to compress the artery from both sides. 
         [0012]    U.S. Patent Publication No. 2004/0092979 discloses a device with paddles that are used to distend the wall of the vaginal vault around the uterus, thus compressing both uterine arteries at the same time. 
         [0013]    U.S. Patent Publication No. 2003/0120286 discloses a clip for encircling and compressing a body lumen, of which a uterine artery is one example. 
         [0014]    U.S. Patent Publication No. 2004/0097962 discloses constriction devices that can be deployed to distend the vaginal wall around the uterus and thus obstruct the uterine arteries. 
       SUMMARY OF THE INVENTION 
       [0015]    The invention provides a device for degenerating a fibroid by using clip-like devices to obstruct the flow of blood through a uterine artery. The invention further provides a method for degenerating a fibroid using a pincher mechanism having two opposable pincher members. The pincher members are placed on opposite sides of a; uterine artery and moved toward each other so as to pinch the uterine artery with sufficient force to substantially obstruct the flow of blood through the artery for a long enough time to degrade the fibroid. 
         [0016]    It should be understood that the embodiments described above are merely exemplary and that additional embodiments may be realized that are within the scope of the invention. The invention is further described in the Detailed Description of the Invention presented below. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    For a more complete understanding of the present invention, reference is made to the following detailed description of the present invention considered in conjunction with the accompanying drawings, in which: 
           [0018]      FIG. 1  is a front perspective illustration of an arterial clip according to an embodiment of the present invention. 
           [0019]      FIG. 2A  is affront view of a component of the arterial clip of  FIG. 1 . 
           [0020]      FIG. 2B  is a side view of the component of  FIG. 2A . 
           [0021]      FIG. 2C  is a front view of the component of  FIG. 2A  in stalled in the arterial clip of  FIG. 1 . 
           [0022]      FIG. 3A  is an illustration of the arterial clip of  FIG. 1  in its first closed position. 
           [0023]      FIG. 3B  is an illustration of the arterial clip of  FIG. 1  in its first open position. 
           [0024]      FIG. 3C  is an illustration of the arterial clip of  FIG. 1  in its second closed position. 
           [0025]      FIG. 3D  is an illustration of the arterial clip of  FIG. 1  in its second open position. 
           [0026]      FIG. 4  is an illustration of the arterial clip, of  FIG. 1  in its first open position straddling a uterine artery. 
           [0027]      FIG. 5  is an illustration of the arterial clip of  FIG. 1  in its second closed position obstructing blood flow through the uterine artery. 
           [0028]      FIG. 6  is an, illustration of the arterial clip of  FIG. 1  in its second open position once again straddling the uterine artery. 
           [0029]      FIG. 7  is an exploded perspective view of an arterial clip according to another embodiment of the present invention. 
           [0030]      FIG. 8  is an illustration of the arterial clip of  FIG. 7  in its open position. 
           [0031]      FIG. 9  is an illustration of the arterial clip of  FIG. 7  in its closed position. 
           [0032]      FIG. 10  is an illustration of the arterial clip of  FIG. 7  being handled with forceps. 
           [0033]      FIG. 11  is an illustration of the arterial clip and forceps of  FIG. 10 , the arterial clip being shown in its open position straddling a uterine artery. 
           [0034]      FIG. 12  is an illustration of the arterial clip of  FIG. 11  in its closed position obstructing the uterine artery after the removal of the forceps. 
           [0035]      FIG. 13  is an illustration of the arterial clip of  FIG. 12  being disassembled so as to release the uterine artery. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0036]      FIG. 1  shows an exemplary arterial clip  10  comprising a generally U-shaped body  12  having a pair of pincher members (“branches”)  14 ,  16  joined by a U-bend  18 . The branches  14 ,  16  are symmetrical to each other and substantially parallel to, a longitudinal axis through the midpoint of the U-bend  18 . The arterial clip  10  also comprises a rod  20  having a solid body  22  having a regular shape (hereinafter referred to as an “expander”) attached eat one end thereof, and a grippable handle  24  attached at the opposite end thereof. The rod  20  extends through the U-bend  18  of the U-shaped body  12  along the aforesaid longitudinal axis, in such a way that the expander  22  is positioned between the branches  14 ,  16 . 
         [0037]    Referring to  FIGS. 2A and 2B , it can be seen that the expander  22  is provided with an indentation  26  along its perimeter. The indentation  26  is shaped to accept the branches  14 ,  16 , as can be seen in  FIG. 2C . Alternatively, the expander  22  may have a raised edge along its perimeter and each of the branches  14 ,  16  may have a slot along its length to receive the raised edge. 
         [0038]    Returning to  FIG. 1 , each of the branches  14 ,  16  has the following sections, in succession away from the U-bend  18 : a first straight section  28 ,  30  that is substantially parallel to the longitudinal axis; a first curved section  32 ,  34  that is bent away from the longitudinal axis, then back toward it so as to form a curve having a concave side facing the longitudinal axis; a second straight section  36 ,  38  that is substantially parallel to the longitudinal axis and closer to the longitudinal axis than the first straight section  28 ,  30  is; a second curved section  40 ,  42  that is bent away from the longitudinal axis, then back toward it so as to form a curve having a concave side facing the longitudinal axis; and a third straight section  44 ,  46  (hereinafter referred to as a “tine”) that is closer to the longitudinal axis than the second straight section  36 ,  38  is. Each of the curved sections  32 ,  34 ,  40 ,  42  is shaped so as to snugly accept the expander  22  between the curved section  32  or  40  on the branch  14  and the corresponding curved section  34  or  42  on the branch  16 . 
         [0039]    The branches  14 ,  16  are biased toward each other so that the tines,  44 ,  46  close against each other when the expander  22  is held between the pair of second curved sections  40 ,  42 , as is shown in  FIG. 3A . This position is referred to hereinafter as “the first position” of the expander  22 . In  FIG. 3B , the expander  22  has been moved toward the U-bend  18  such that it is at a position between the second straight sections  36 ,  38  (hereinafter “the second position”), causing the tines  44 ,  46  to separate thereby opening the clip  10 . The expander  22  is moved by bracing the body  12  of the arterial clip (e.g., using a tube or forceps, neither of which is shown) and pulling on the rod  20  from the handle  24  end. In  FIG. 3C , the expander  22  has been moved to a “third position”, where it is held snugly between the pair of first curved sections  32 ,  34 , allowing the tines  44 ,  46  to close against each other. Finally, in  FIG. 3D , the expander  22  has been moved to a “fourth position”, which is a position between the first straight sections  28 ,  30 , thus separating the tines,  44 ,  46  of the clip  10 . 
         [0040]      FIGS. 4-6  show steps in the operation of the arterial clip  10 . For the purpose of the following disclosure, and for any further disclosures made hereinafter, the relevant features of the female anatomy are the vaginal vault  48 , the vaginal wall  50 , the uterine artery  52  and the uterus  54 . 
         [0041]    First, an incision (not shown) is made in the vaginal wall  50  and the uterine artery  52  is dissected. As shown in  FIG. 4 , the expander  22 , has been moved to its second position, opening the arterial clip  10 . The opened arterial clip  10  is inserted through the incision such that the tines  44 ,  46  are positioned on either-side of the uterine artery  52 . The expander  22  is then moved to its third position, allowing the tines  44 ,  46  to close, as shown in  FIG. 5 , thus squeezing the uterine artery  52  shut and obstructing blood flow for a period of time sufficient to degenerate or kill the fibroid without killing the adjacent tissue. Preferably, blood flow through the artery is blocked for 6 to 8 hours, after which the expander  22  is moved to its fourth position, opening the arterial clip  10 , as shown in  FIG. 6  and allowing normal blood flow to resume. The arterial clip  10  is then pulled back through the incision, using forceps (not shown) or some other gripping device, and the incision is closed. 
         [0042]    During the foregoing procedure, it is important that the position of arterial clip  10  be known relative to the uterine artery  52 , so that the clip  10  is not mistakenly applied to another blood vessel or to the ureter (not shown). The position of the arterial clip  10  relative to the uterine artery  52  may be determined by any of a number of imaging techniques and/or techniques for monitoring the flow of blood through blood vessels. 
         [0043]    Appropriate sensors for imaging and/or blood flow monitoring include blood flow sensors, sound sensors, pressure sensors, or electromagnetic radiation sensors (e.g., X-ray detectors). Sensors may be mounted on the arterial clip  10 , on the forceps or other tool used to place or remove the arterial clip  10 , or on implements temporarily attached to the arterial clip  10  during insertion. Since any sensor that is used will have associated wiring it is preferable to use an implement that can be removed after the arterial clip  10  is applied to the uterine artery  52 . In the absence of such an implement, the patient may move about with the arterial clip  10  in place. 
         [0044]    Techniques that may be used include direct visual examination, abdominal ultrasound, Doppler ultrasound, X-ray detection, sound detection, and angiography. Direct visual examination is the preferred method of application. Ultrasound techniques are also beneficial, because they are reliable, real-time techniques for imaging the position of the arterial clip  10  in relation to the uterine artery  52  while the procedure is underway. Doppler ultrasound techniques are especially useful, because they can also be used to determine when blood flow ceases or is restored. Optical fibers may also be used to illuminate the organs, and transmit images to an optical viewer. Adaptations of suitable techniques for use with the arterial clip  10 , or other devices that may, be discussed herein, will be apparent to a person skilled in the application of such techniques to surgical procedures. 
         [0045]      FIG. 7  illustrates an, example of a second arterial clip,  56 , in exploded view. The arterial clip  56  comprises three parts. The first part is a short pincher member  58  having a hook  60  at one end and a thin lip  62  at the other end. The short pincher member  58  is made of a bioabsorbable polymer. The bioabsorbable polymers that can be used to make devices according to the present invention include conventional biocompatible, bioabsorbable polymers including polymers selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylene oxalates, polyalkylene diglycolates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, poly(propylene fumarates), absorbable poly(ester urethanes), biomolecules (i.e., biopolymers such as collagen, elastin, bioabsorbable starches, etc.) and combinations and blends thereof. The polyoxaesters include the polymers based on 3,6-dioxaoctanedioic acid, 3,6,9-trioxaundecanedioic acid, and the diacid known as polyglycol diacid, which can be made from the oxidation of low molecular weight polyethylene glycol. Currently, aliphatic polyesters are among the preferred absorbable polymers for use in making the implants according to the present invention. Aliphatic polyesters can be homopolymers, copolymers (random, block, segmented, tapered blocks, graft, triblock, etc.) having a linear, branched or star structure. Suitable monomers for making aliphatic homopolymers and copolymers may be selected from the group consisting of, but are hot limited, to lactic acid (both L- and D-isomers), lactide (including L-, D-, and meso-lactide), glycolic acid, glycolide, ε-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), and combinations thereof. Aliphatic polyesters can be homopolymers, copolymers (random, block, segmented, tapered blocks, graft, triblock, etc.) having a linear, branched or star structure; alternately they can be a component of a cross-linked network. It is to be understood that exemplary bioabsorbable, biocompatible polymers may be generally synthesized by a ring-opening polymerization of the corresponding lactone monomers or by polycondensation of the corresponding hydroxy-acids, or by combinations of these two polymerization methodologies. Thus as used herein, the term “polyglycolide” is understood to include polyglycolic acid. Further, the term “polylactide” is understood to include polymers of L-lactide, D-lactide, meso-lactide, blends thereof, and lactic acid polymers and copolymers in which other moieties are present in amounts leas than 50 mole percent. Other aliphatic polyesters that may provide utility include the hydroxybutyrates and polyhydroxyvalerates. 
         [0046]    The second part is a long pincher member  64  having a tip  66  at one end, a shaft  68 , a handle  70  at the other end of the shaft  68 , and a slot  72  in the body of the long pincher member  64  that is positioned between the tip  66  and the handle  70 . The handle  70  of the long pincher member  64  is bulky, such that it can be gripped securely by tweezers-, forceps or other gripping devices. The long pincher member  64  is sufficiently long (i.e., roughly 5-6 cm) so that the end of the shaft  68  with the handle  70  projects into the vaginal vault  48  (not shown) when the short part  58  of the arterial clip  56  is positioned at the uterine artery  52  (not shown). The tip  66  of the long pincher member  64  and the hook  60  of the short pincher member  58  are shaped such that the hook  60  can securely latch over the tip  66 . Further, the slot  72  of the long pincher member  64  and the lip  62  of the short pincher member  58  are shaped such that the lip  62  may be inserted into the slot  72 . Overall, the surfaces of the long pincher member  64  are smooth and shaped to be easily withdrawn through a small opening in the vaginal wall  50  (not shown). 
         [0047]    Both the short-pincher member  58  and the long pincher member  64  may be provided with pins  74 ,  76 , respectively, to receive pressure from a forceps, while allowing the arterial clip  56  to rotate about the axis formed by the pins  74 ,  76  without moving the short pincher member  58  or long pincher member  64  relative to each other. This arrangement is explained more fully in relation to  FIG. 10 . 
         [0048]    The third piece is a wire  78  that is long enough to extend through most of the length of the long pincher member  64  and has, a hooked end  80  with a tip  82 . The long pincher member  64  has an interior bore (not shown) to receive the wire  78 , one end of the bore being within the slot  72 . The short pincher member  58  also has an interior bore (hot shown) to receive the wire  78  within an opening (not shown) at the end of the lip  62 . Turning again to the long pincher member  64 , the handle  70  of the long pincher member  64  may have a second bore (not shown) positioned to receive the tip  82  of the hook  80  that is turned forward along the wire  78 . 
         [0049]      FIG. 8  shows the arterial clip of  FIG. 7 , assembled and in its open position. As can be seen, the lip  62  of the short pincher member  58  fits into the slot  72  of the long pincher member  64 . The wire  78  extends through the body of the long pincher member  64  and into the lip  62  of the short pincher member  58 . Depending on the shapes of the lip  62  and slot  72 , the wire  78  could extend through the lip  62  and forward [back] into the body of the long pincher member  64 . 
         [0050]      FIG. 9  shows the arterial clip  56  of  FIG. 7 , assembled and in its closed position. The hook  52  of the short pincher member  58  is securely latched over the tip  66  of the long pincher member  64 , with the lip  62  of the short pincher member  58  and the wire  78  remaining in the positions shown in  FIG. 8 . 
         [0051]      FIG. 10  shows the arterial clip  56  being gripped between opposed tongs  84 ,  86  of a forceps  88 . In such an arrangement, it can be seen that the shaft  68  of the long pincher member  64  must lie outside of the body of the forceps  88  while the short pincher member  58  and the long pincher member  64  are held by the tongs  84 ,  86  of the forceps  88 . Such a position is allowed by rotation of the arterial clip  56  about the axis formed by the aforementioned pins  74 ,  76  (see, e.g.,  FIG. 7 ). 
         [0052]      FIGS. 11 through 13  show steps in the operation of the arterial clip  56 . First, an incision (not shown) is made in the vaginal wall  50  and the uterine artery  52  is dissected. The opened arterial clip  56  is manipulated, using the forceps  88 , until the short pincher member  58  is on one side of the uterine artery  52  and the long pincher member  64  is on the other side of the uterine artery  52 , as shown in  FIG. 11 . 
         [0053]    Referring to  FIG. 12 , the short pincher member  58  and the long pincher member  64  are pressed together, causing the hook  60  of the short pincher member  58  to catch the tip  66  of the long pincher member  64 , thus locking the short pincher member  58  and the long pincher member  64  together in the closed position. When the arterial clip  56  is in this closed position, blood flow through the uterine artery  52  is blocked. The clip  56  is, then released and forceps  88  removed, making sure that the handle  70  of the arterial clip  56  remains within the vaginal vault  48 . 
         [0054]    The arterial clip  56  remains in the closed position for a period of time needed to degenerate or kill the fibroid without killing the adjacent tissue. The arterial clip  56  is then opened by gripping the handle  70  with tweezers or a similar gripping implement, gripping the hooked end  80  of the wire  78  with another implement, and withdrawing the wire,  78  from the arterial clip  56  so that the short pincher member  58  and long pincher member  64  are no longer-secured, to each other. The wire  78  is removed from the vaginal vault  48 , and the short pincher member  58  of the arterial clip  56  is separated from the long pincher member  64  by gently shaking the long pincher member  64 . Separating the short pincher member  58  and the long pincher member  64  relieves pressure on the uterine artery  52  and allows normal blood flow to resume. The long pincher member  64  is then pulled back through the incision and removed from the vaginal vault  48 . The incision is then closed. The short pincher member  58  remains in the body, where it degrades and is absorbed. 
         [0055]    During the procedure, the position of the arterial clip  56  relative to the uterine artery  52  may be determined by the same techniques that were identified above with respect to the arterial clip  10 . Adaptations of suitable techniques for use with the arterial clip  56 , will be apparent to a person skilled in the application of such techniques to surgical procedures. 
         [0056]    It should be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications thereto without departing from the spirit and scope of the present invention. For example, in the first arterial clip  10 , the branches  14 ,  16  could be biased apart from each other and, instead of the expander  22 , a collar (not shown) could be placed around the outside of the clip. The arterial clip  10  could be re-dimensioned such that the collar would cause then clip to close when it was passed over the bent sections  32 ,  34  or  40 ,  42  and to open when it passed over straight sections  28 ,  30  or  36 ,  38 . With respect to the second arterial clip  56 , the hook-and-tip mechanism discussed can be replaced by a ratcheting lock such as those used in some cable ties or by any other mechanism that will hold, the ends of the short pincher member and the long pincher member together while allowing the two pincher members to separate when the lip  62  is separated from the slot  72 . Instead of using a short pincher member  58 , a longer pincher member could be used, such that the ends of both pincher members of the device remain within the vaginal vault. In such an arrangement, restraining devices other than the wire  78  could be used to restrain the lip  62  within the slot  72 . All such variations and modifications, including those discussed above, are intended to be included within the scope of the invention, which is described, in part, in the claims presented below.