Abstract:
Devices, systems and methods for grasping, manipulating and retaining tissue are provided. In different aspects, devices, systems and methods for locating tissue; for guiding instruments to tissue; for grasping tissue; and for retaining and manipulating tissue are provided. Such tissue may include the cervix of a female patient. A device may have a distal portion having a sound configured to enter a cervical os without causing undue trauma or discomfort to the patient, and a retention element such as a spike configured to engage and retain a patient&#39;s cervix. Devices may include a proximal portion, such as a handle. Devices may be configured to co-operate with other instruments. Cooperation with other instruments may include serving as a mount for instruments and guiding instruments. Such devices may aid in the placement and operation of instruments for therapeutic and diagnostic procedures, such as, for example, treating uterine disorders and conditions.

Description:
FIELD OF THE INVENTION  
         [0001]    The invention relates generally to the field of devices and methods for holding and manipulating body tissue. In particular, the invention is directed to devices and methods for holding and manipulating the cervix and uterus of a female patient.  
         BACKGROUND OF THE INVENTION  
         [0002]    It is often desirable to hold, maneuver, and retain tissue during medical procedures. Devices for gripping, holding, and manipulating tissue are thus often very useful during medical procedures, particularly ones involving tissues, organs, and structures that are relatively inaccessible or otherwise difficult to reach or to retain.  
           [0003]    In many medical procedures, it is useful to locate the cervix and cervical os of a female patient. For example, location of the cervical os and cervix is necessary for proper positioning for the performance of a dilatation and curettage procedure. In order to perform a hysterectomy, particularly with a transvaginal approach, it is often useful to grasp the cervix. This may aid in orienting the uterus, in reducing unwanted motion of the uterus during a procedure, or to manipulate the uterus into a favorable position during treatment. Devices and methods for grasping, retaining and manipulating a uterus may be useful in many other medical procedures as well.  
           [0004]    Hysterectomy (surgical removal of the uterus) is performed on approximately 800,000 women annually in the United States. Hysterectomy is often the therapeutic choice for the treatment of uterine cancer, adenomyosis, menorrhagia, uterine prolapse, dysfunctional uterine bleeding (abnormal menstrual bleeding that has no discrete anatomic explanation such as a tumor or growth), and muscular tumors of the uterus, known as leimyoma or uterine fibroids.  
           [0005]    However, hysterectomy is a drastic treatment, entailing the removal of the uterus and the resulting loss of reproductive function. Thus, any method which can approximate the therapeutic result of a hysterectomy without removing the uterus would be a significant improvement in this field. Newer treatment methods have been developed for some diseases which may spare these women a hysterectomy.  
           [0006]    In 1995, it was demonstrated that uterine fibroids could be treated without hysterectomy using a non-surgical therapy, specifically comprising bilateral intraluminal occlusion of the uterine arteries (Ravina et al., “Arterial Embolization to Treat Uterine Myomata”, Lancet Sept. 9, 1995; Vol. 344; pp. 671-692, incorporated in its entirety herein). This technique is known as “uterine artery embolization”. In this technique, uterine arteries are accessed via a transvascular route from a common femoral artery into the left and right uterine arteries.  
           [0007]    The uterus has a dual (or redundant) blood supply, the primary blood supply being from the bilateral uterine arteries, and the secondary blood supply from the bilateral ovarian arteries. Consequently, when both uterine arteries are occluded, i.e. bilateral vessel occlusion, the uterus and the fibroids contained within the uterus are both deprived of their blood supply. However, as demonstrated by Ravina et al., the effect on the fibroid is greater than the effect on the uterus. In most instances, the fibroid withers and ceases to cause clinical symptoms. See also Burbank, et al., “Uterine Artery Occlusion by Embolization or Surgery for the Treatment of Fibroids: A Unifying Hypothesis—Transient Uterine Ischemia,” The Journal of the American Association of Gynecologic Laparoscopists, November 2000, Vol. 7, No.4 Supplement, pp. S3-S49. U.S. Pat. No. 6,254,801, to Burbank et al., entitled “Methods for Occlusion of the Uterine Arteries,” describes numerous devices and methods useful for occluding a uterine artery by penetrating the tissue of the patient to access the uterine artery.  
           [0008]    However, catheter-based uterine artery embolization under radiologic direction requires specialized equipment and sophisticated procedures. Accordingly, far fewer uterine artery embolizations than hysterectomies are performed for uterine fibroids which are symptomatic.  
           [0009]    What is needed, therefore, are devices and methods to locate, retain and manipulate the cervix, uterus and related tissues and structures that can be used by physicians of ordinary skill in a simple medical setting or environment to aid in therapeutic procedures.  
         SUMMARY OF THE INVENTION  
         [0010]    The invention is directed to devices and methods for locating, retaining, and manipulating a cervix and uterus and related tissues and structures of a female human patient. Thus, in one embodiment, the invention provides devices for locating a cervix and a cervical os comprising an elongated shaft having a distal portion configured for entry into a cervical os. The elongated shaft has a proximal portion, which may include a handle and may be detachable from the distal portion. A gripping mechanism configured for engaging a cervix and/or a uterus may be operatively connected to the elongated shaft effective to retain the device in a desired location adjacent the cervix. A guide rail may also be connected to the proximal portion of the elongated shaft. The elongated shaft distal portion preferably has a rounded tip, and may comprise a soft material, or a malleable material, or both. In further embodiments, at least a portion of the guide rail may be configured to cooperate with other instruments. For example, in some embodiments, the guide rail is configured to receive a cylindrical connector, rounded sleeve, or other attachment element attached to another instrument effective to allow the tenaculum to work cooperatively with the other instrument.  
           [0011]    A tenaculum having features of the invention may be used to guide, stabilize, anchor, or otherwise control the relationship between body tissue and another instrument. A tenaculum having features of the invention may be configured to grasp and hold onto the cervix of a female patient to, for example, aid in placement and retention of uterine artery occlusion devices. A tenaculum having features of the invention may be configured to function cooperatively with other devices to provide occlusion of the uterine arteries. Such a tenaculum may provide guidance for the placement and use of other devices, such as uterine artery occlusion devices, including providing guidance along centerline of the cervix. A tenaculum having features of the invention may provide a locking feature effective to maintain the axial position relative to the cervix of a device such as a uterine artery occlusion device. A tenaculum having features of the invention may include detachable portions, so that a distal portion configured to be completely contained within the vagina, cervix and uterus may be deployable while attached to a cervix, providing greater mobility and comfort to a patient during treatment.  
           [0012]    In further embodiments, the invention provides methods for gripping a cervix, comprising inserting into a cervical os a sound of a tenaculum having an elongated shaft having a distal portion configured for entry into a cervical os and a proximal portion, a handle operatively connected to said proximal portion of said elongated shaft, a gripping mechanism operatively connected to said elongated shaft and configured for engaging a cervix effective to retain said device in a desired location adjacent said cervix, and a guide rail connected to said proximal portion of said elongated shaft, and engaging said cervix with said gripping mechanism.  
           [0013]    The methods further comprise methods for manipulating a cervix and uterus, comprising inserting into a cervical os and/or uterine canal a sound of a tenaculum having an elongated shaft having a distal portion configured for entry into a cervical os and a proximal portion, a handle operatively connected to said proximal portion of said elongated shaft, a gripping mechanism operatively connected to said elongated shaft and configured for engaging a cervix effective to retain said device in a desired location adjacent said cervix, and a guide rail connected to said proximal portion of said elongated shaft; engaging said cervix with said gripping mechanism; and manipulating said handle portion so as to maneuver and/or retain said cervix and uterus into and/or in a desired position.  
           [0014]    The devices, systems and methods embodying features of the invention thus provide tools and methods to aid in the treatment of diseases and conditions that may require grasping and retaining a cervix and uterus. Devices and methods having features of the invention may be used to provide improved treatments for serious conditions and diseases, including uterine fibroids, adenomyosis, dysfunctional uterine bleeding (DUB), postpartum hemorrhage, and other uterine disorders. The devices and methods are simple and easy to use, simple to remove, and thus provide many advantages over other methods and devices for treating such conditions and diseases.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    [0015]FIG. 1A is a perspective view of an angled tenaculum embodying features of the invention.  
         [0016]    [0016]FIG. 1B is a perspective view of a linear tenaculum embodying features of the invention with the retention element in a disengaged configuration.  
         [0017]    [0017]FIG. 1C is a longitudinal cross-sectional view of the deployable linear tenaculum illustrated in FIG. 1B taken along line  1 C- 1 C.  
         [0018]    [0018]FIG. 2A is a perspective view of a linear tenaculum embodying features of the invention with the retention element in an engaged configuration.  
         [0019]    [0019]FIG. 2B is a transverse cross-sectional view of the linear tenaculum illustrated in FIG. 2A taken along line  2 B- 2 B.  
         [0020]    [0020]FIG. 3A is a perspective view of a deployable angled tenaculum embodying features of the invention after separation of a distal portion from proximal handle portions.  
         [0021]    [0021]FIG. 3B is a perspective view of a deployable linear tenaculum embodying features of the invention after separation of a distal portion from a proximal portion.  
         [0022]    [0022]FIG. 4A illustrates an angled tenaculum having features of the invention assembled with a medical instrument.  
         [0023]    [0023]FIG. 4B illustrates a linear tenaculum having features of the invention assembled with a medical instrument.  
         [0024]    [0024]FIG. 5 is a schematic diagram of a reproductive system of a human female illustrating the placement of a tenaculum embodying features of the invention partially into the cervical os within the vagina of a female human patient. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0025]    The invention provides systems  10 , devices and methods for gripping and manipulating tissue. A tenaculum  12  embodying features of the invention may be used alone to grip and manipulate tissue, or with other devices as part of a system  10  to provide a stable foundation for, e.g., the occlusion of uterine arteries in a female patient. A tenaculum  12  embodying features of the invention is suitable for gripping a cervix, uterus, or other related structure of a female patient, and for manipulating the position of cervix, uterus, or other related structure of a female patient. Embodiments of tenacula  12  suitable for use in a system  10  having features of the invention include an angled tenaculum  12  embodying features of the invention, as shown in FIG. 1A and a linear tenaculum  12  embodying features of the invention, as shown in FIGS. 1B and 1C. It will be understood that tenaculum features and elements discussed with respect to an angled tenaculum  12  may also apply to a linear tenaculum  12  as well, and that tenaculum features and elements discussed with respect to a linear tenaculum  12  may also apply to an angled tenaculum  12 .  
         [0026]    As shown in FIG. 1, a tenaculum  12  has a tenaculum shaft  14  that may be connected with handle or handles  16 . Shaft  14  has a distal portion comprising a tenaculum sound  18  with a distal tip  20 . A sound  18  is preferably malleable or flexible, and may be resilient. Flexibility and malleability are useful, for example, in order to accommodate a patient&#39;s anatomy, including the orientation and disposition of a patient&#39;s cervix and cervical os. A sound  18 , and a distal tip  20  are preferably configured to contact tissue without causing undue trauma or discomfort to a female patient. A configuration that does not cause undue trauma or discomfort, and tissue contact without undue trauma or discomfort, may be termed “atraumatic”; entry of such a device or element within a cervical os may be termed “atraumatic entry.” For example, a distal tip  20  is preferably rounded in order to reduce the possibility of trauma to the cervix and to reduce possible discomfort to the patient as sound  18  is introduced into a cervix via a cervical os, enabling a tenaculum  12  to provide a structure for guiding subsequent placement of another device or devices of a system  10 . In addition, a sound  18  and distal tip  20  may be sized, angled, finished, coated, or otherwise configured to reduce possible trauma and discomfort during use.  
         [0027]    A tenaculum  12  may be secured in place by application of a retention element such as tenaculum spike  22  into tissue so as to retain a tenaculum  12  in place. A retention element such as spike  22  or spikes  22  may be disposed on an engagement arm  24  and configured to move into place so as to hold tissue. A spike  22  may be disposed so as to engage tissue, for example, when a tenaculum  12  is in place with a sound  18  within a cervical os, by movement of engagement arm  24  so as to place a spike  22  into tissue adjacent sound  18 . Thus, for example, closure of tenaculum handles  16  of an angled tenaculum  12  (e.g., by pressing tenaculum handles  16  closer together), rotating engagement arm  24  around pivot  26  is effective to move spike  22  towards sound  18 , and is effective to press spike  22  into tissue in a tissue-engaging configuration. A spike  22  pressed into cervical tissue is effective to retain a tenaculum  12  in place within a patient&#39;s vagina when sound  18  is in place within a cervical os of a patient. A tenaculum  12  may include multiple spikes  22 . It will be understood that other retention elements configured to retain a tenaculum  12  in place within or on a patient&#39;s body, such as serrations, grooves, or other elements, may be used with or in place of a spike  22 . A retention element such as a spike  22  may be held in a tissue-engaging configuration by a lock mechanism  28 , such as a ratchet shown in FIG. 1A.  
         [0028]    A spike  22 , or other retention element, allows an operator to manipulate a patient&#39;s tissue with a tenaculum  12  by, for example, pulling on a handle  16  when spike  22  is engaged with tissue so that the tissue follows the movement of the tenaculum  12 . Such manipulation of a patient&#39;s tissue may be desirable to place the tissue in a desired position or orientation; for example, pulling on a cervix extends the cervix and stretches adjacent tissue, such as the vaginal formix, and pulls the uterine arteries towards the vagina so that these arteries become stretched and compressed between vaginal formix and uterus so as to occlude, or to facilitate the occlusion of, the uterine arteries. A tenaculum  12  embodying features of the invention may be used with devices and methods for occlusion of uterine arteries, including occlusion devices with pressure-applying members. For example, occlusion devices may be guided by, may mount on, may be retained by, and may be stabilized by a tenaculum  12 .  
         [0029]    A shaft  14  of an angled tenaculum  12  may include a guide rail  30  disposed proximal to sound  18 . A guide rail  30  may have a smooth outer surface or may have threads  32  on at least a portion of its length. A sound  18  and guide rail  30  are preferably collinear, and may comprise parts or ends of a single shaft  14 .  
         [0030]    A locking tube  34  may be attached to, or mounted on, a guide rail  30 . A locking tube  34  may be configured to engage a guide rail  30  by having a distal collar portion  36  (which preferably has a bore with internal threads) that is configured to engage threads  32  of a guide rail  30 . A locking tube  34  may also have a proximal portion  38 , which may be configured as a handle for manipulation by an operator, connected to the distal collar portion  36  by a connecting portion  40 . In preferred embodiments, a connecting portion  40  is flexible; for example, a connecting portion  40  may be a piece of flexible tubing sized to tightly engage the distal  36  and proximal  38  portions of a locking tube  34 .  
         [0031]    An angled tenaculum  12  embodying features of the invention may have a pair of handles  16 , or may have a handle  16  comprising only a single handle portion. A linear tenaculum  12  typically has a single handle portion  16 . A linear tenaculum  12  may have a shaft  14  including a distal portion  42  and a proximal portion  44 . Sound  18  with distal tip  20  is typically collinear with shaft  14  of a linear tenaculum  12 . A handle  16  may be attached to a proximal portion  44  of a linear tenaculum  12 ; alternatively, a proximal portion  44  may serve as a handle  16  when held by an operator. In either case, a shaft  14  of a linear tenaculum  12 , or portions thereof, may serve as a guide rail  30 .  
         [0032]    A linear tenaculum  12  having features of the invention may comprise multiple shafts or tube assembled together to form a shaft  14 . For example, as illustrated in FIG. 1C, a shaft  14  of a linear tenaculum  12  may comprise a bolt  46  having bolt threads  48  on at least a distal portion, a proximal body tube  50  and a distal body tube  52  having inner threads  54  complementary to bolt threads  48 . A proximal body tube  50  may be configured to engage a distal body tube  52  by, for example, having a distal end  56  comprising a lip  58  with a stop  60 . The lip  58  of a proximal body tube  50  may be configured to accept a portion of a distal body tube  52 , and the stop  60  may be configured to regulate the length of distal body tube  52  held within lip  58 . An outer tube  62  may be disposed around proximal body tube  50  and configured to move longitudinally along shaft  14 .  
         [0033]    A retention element such as a spike  22  of linear tenaculum  12  is disposed on an engagement arm  24  which may be connected to shaft  14  at a joint  64 . In preferred embodiments, a joint  64  is a fixed point of attachment between engagement arm  24  and shaft  14 ; movement of retention element such as spike  22  towards shaft  14  is enabled by the flexibility of at least a portion of engagement arm  24 . Alternatively, joint  64  may comprise a pivot, a spring, a flexible sleeve, or other form of flexible attachment mechanism to join engagement arm  24  with shaft  14 . Closure of engagement arm  24 , effective to move spike  22  near to shaft  14  and sound  18  for engagement with tissue, may be effected, for example, by distal movement of handle  16 , causing distal movement of a closure element such as a closure sleeve  66  disposed about shaft  14  so as to press on joint  64  so as to move spike  22  towards shaft  14 . A linear tenaculum  12 , as illustrated in FIGS. 1 and 2 provides the advantage of a much lower profile than, for example, an angled tenaculum  12  as illustrated in FIG. 1. A lower profile may be advantageous during use within a patient&#39;s vagina, for example, in that it leaves more room around the device for other instruments, for observation, and may be more comfortable for the patient than other designs.  
         [0034]    An engagement arm  24  (carrying a spike  22 ) is preferably a flexible arm, and is preferably fixedly joined to shaft  14  at a joint  64 . As illustrated in the Figures, joint  64  may be a depression, such as a “D”-shaped slot in a round shaft  14 , into which a complementarily-shaped end  68  of engagement arm  24  is fitted. End  68  may be welded, pinned, glued, or otherwise fixedly attached to shaft  14 . An engagement arm  24  may be made with metal, such as stainless steel, or other durable, flexible material, including polymers. Alternatively, a joint  64  may include a spring, or a hinged joint, or both.  
         [0035]    A spike  22  disposed on portions of engagement arm  24  may be moved closer to shaft  14  by pressure effective to flex engagement arm towards shaft  14  effective to place it in a tissue-engaging configuration. For example, a closure sleeve  66  may be disposed around shaft  14 , preferably outside proximal body tube  50  and configured to move (e.g., slide) longitudinally along proximal body tube  50 . In embodiments of the invention, an outer tube  62  may have a distal end configured to engage a closure sleeve  66  effective to cause it to move longitudinally along proximal body tube  50 .  
         [0036]    A closure sleeve  66  held in place by a closure pin  70 , pressing on an engagement arm  24  is effective to close and retain engagement arm  24  in a closed configuration. An engagement arm  24  having a spike  22  disposed in such a closed configuration and in contact with tissue is effective to grip tissue and to retain a tenaculum  12  in place engaged with the tissue.  
         [0037]    A closure sleeve  66  may be locked into place so as to maintain a spike  22  in a tissue-engaging configuration. A closure sleeve  66  may have a locking slot  72  configured to accept a closure pin  70 . For example, a closure pin  70  attached to shaft  14  may be lodged within a locking slot  72  so as to hold a closure sleeve  66  in a configuration that contacts engagement arm  24  so as to place a spike  22  into a tissue-engaging configuration. A closure pin  70  is preferably disposed on distal shaft portion  42 , preferably on distal body tube  52 . Preferably, a locking slot  72  has a non-linear shape, including, for example, a bend such as a right-angled bend, so that a locking slot  72  has a longitudinal portion disposed along a longitudinal axis and a latitudinal portion disposed at an angle (e.g., at a right angle) to a longitudinal axis. A non-linear slot is effective to retain a closure pin  70  and constrain a closure sleeve  66  from further longitudinal motion after lodgment of closure pin  70  within locking slot  72 . Such lodgment may be obtained, for example, by longitudinal movement of closure sleeve  66  so as to bring a closure pin  70  within a longitudinal portion of a locking slot  72 , followed by rotational movement of closure sleeve  66  so as to place closure pin  70  within a latitudinal portion of the locking slot  72 .  
         [0038]    A closure sleeve  66  may be moved into place by distal movement of an outer body tube  62  disposed around proximal body tube  50 . A distal portion  74  of outer body tube  62  is preferably configured to engage with a proximal portion  76  of a closure sleeve  66  so as to transmit both longitudinal and rotational motion from the outer body tube  62  to the closure sleeve  66 . For example, a distal portion  74  may have a step or steps configured to engage a complementary step or steps of a proximal portion  76  as illustrated in FIGS. 1 and 2, effective to allow rotation of an outer body tube  62  to be transferred to a closure sleeve  66 . As discussed above, such rotational motion of closure sleeve may be effective to lodge a closure pin  70  within a locking slot  72 .  
         [0039]    A tenaculum having features of the invention may be configured for disassembly during use, resulting in separate distal and proximal portions, so as to leave a distal portion engaged with tissue while allowing removal of a proximal portion. Removal of a proximal portion provides another means for providing greater comfort and freedom of movement to a patient receiving treatment. A tenaculum configured for disassembly during use may be termed a “deployable tenaculum.” For example, an angled tenaculum  12  as illustrated in FIG. 3A may have detachable handles  16  configured for detachment from, and re-attachment to, a distal portion of angled tenaculum  12  that includes pivot  26 , engagement arm  24 , spike  22 , and sound  18 . The detachable distal portion may thus be deployed while engaged with tissue, and remain engaged with tissue, after detachment of handles  16 . Handles  16  may be re-attached at a later time if desired, and may, for example, aid in removal of the distal portion from the patient&#39;s tissue.  
         [0040]    In embodiments of tenacula having features of the invention, a linear tenaculum  12  may be configured to disassemble into a separate distal portion  42  and a separate proximal portion  44 . Such separation allows the removal of proximal portion  44  from within a patient&#39;s body while distal portion  42  remains in place during use. As illustrated in FIG. 3B, a spike  22  and engagement arm  24  may be retained in a tissue-engaging configuration after deployment of the distal portion  42  by locking a closure sleeve  66  into place with a closure pin  70  lodged within locking slot  72 .  
         [0041]    [0041]FIG. 3B provides a perspective view of a deployable linear tenaculum  12 , including a distal portion  42  and a proximal portion  44  of a disassembled deployable linear tenaculum  12 . Portions  42  and  44  of a linear tenaculum  12  may be held together by a bolt  46 , with a portion of distal body tube  52  held within a lip  58 . Alternatively, a distal portion  42  of shaft  14  may be attached with a proximal portion  44  of shaft  14  by a lip  58  and distal body tube  52  having complementary threads configured to form a threaded attachment. Thus, for example, distal portion  42  may be attached to proximal portion  44  by screwing the portions together, and distal portion  42  may be detached from proximal portion  44  by unscrewing the portions.  
         [0042]    Thus, a deployable linear tenaculum may have a sound  18  for entry into the cervical os, a shaft  14  for manipulating and controlling the cervix, a spike  22  for grasping the cervix disposed on an engagement arm  24 , a mechanism to open and close the spike  22  (such as a joint  64  configured to be operated by closure sleeve  66  disposed around shaft  14 ), and a mechanism to deploy the distal portion  42  (such as by unscrewing bolt  46 ). An advantage of a tenaculum  12  having a deployable distal portion  42  over other configurations of tenacula  12  having features of the invention is that the deployed distal portion  42  may be fully contained within the vagina and uterus of the patient during use after deployment. The deployable distal portion  42  may serve as a guide and/or as a base or mounting element for the use with other instruments.  
         [0043]    Systems  10  including an angled tenaculum  12  and a linear tenaculum  12  engaged with other instruments are illustrated in FIGS. 4A and 4B respectively. Other instruments suitable for use with a tenaculum  12  having features of the invention include clamps and constrictors configured for applying pressure to tissue, such as a cervix or uterus of a female patient. Although it will be understood that many devices are suitable for use in a system  10  with a tenaculum  12  having features of the invention, one example of such an instrument is an occlusion device  80  with pressure-applying elements  82  as illustrated in FIGS. 4A and 4B. A system  10  including an angled tenaculum  12  and a device  80  is illustrated in FIG. 4A; a system  10  including a linear tenaculum  12  and a device  80  is illustrated in FIG. 4B. Occlusion devices with pressure-applying elements are disclosed in co-pending U.S. patent applications “Occlusion Device with Deployable Paddles for Detection and Occlusion of Blood Vessels” by Fred H. Burbank et al., assigned to Vascular Control Systems Inc., and “Deployable Constrictor for Uterine Artery Occlusion,” by Fred H. Burbank et al., assigned to Vascular Control Systems Inc., both applications filed on the same day as the present application, and both hereby incorporated by reference in their entirety.  
         [0044]    A device  80  may be operatively connected with a tenaculum by an attachment sleeve  84 , which may be configured to at least partially surround or enclose a portion of guide rail  30 . An attachment sleeve  84  may be configured to engage a guide rail  30  effective that an attachment sleeve  84  may slide longitudinally along the guide rail  30 . An attachment sleeve  84  is preferably configured to slide along portions of a guide rail  30  having a smooth outer surface and to slide along portions of a guide rail  30  having threads  32 . Such sliding movement of an attachment sleeve  84  carries device  80  along the path defined by guide rail  30  of tenaculum  12 . Thus, engagement of an attachment sleeve  84  with a guide rail  30  is effective to guide and direct the movement of a device  80  by a tenaculum  12 . Where locking tube  34  is not moved, or where it is locked into a position, such engagement between an attachment sleeve  84  of a device  80  is effective to immobilize and retain device  80  with respect to a tenaculum  12 .  
         [0045]    A tenaculum  12  may engage a patient&#39;s tissue; thus, where a device  80  is engaged with a tenaculum  12 , the positioning and movement of a device  80  relative to a patient&#39;s tissue may be guided and directed by a tenaculum  12 . For example, the advancement of a locking tube  34  effective to press distal collar portion  36  of locking tube  34  against attachment sleeve  84  is effective to advance attachment sleeve  84  distally, and thereby also moving device  80  and pressure-applying elements  82  in a distal direction. Advancement of an outer tube  62  distally along a shaft  14  of a linear tenaculum  12  is similarly effective to advance an attachment sleeve  84  distally, and thereby to move a device  80  and pressure-applying elements  82  in a distal direction. Such distal movement may be useful, for example, to advance a device  80  towards a cervix where a device  80  is mounted on a tenaculum  12  is engaged with cervical tissue.  
         [0046]    A schematic diagram of female human reproductive anatomy and related structures is shown in FIG. 5, illustrating the placement and use therein of a tenaculum  12  embodying features of the invention. The anatomical features shown in FIG. 5 include uterus  90 , vagina  92 , cervix  94 , vaginal formix  96 , cervical os  98 , and uterine arteries  100  (which provide a large fraction of the uterine blood supply). A uterine fibroid  102  is also illustrated. As discussed above, and as disclosed in U.S. application Ser. No. 09/908,815, filed Jul. 20, 2001, to Burbank et al. (“&#39;815 application”), co-assigned with the present application, the entire contents of which are incorporated by reference herein, reduction or abolition of blood flow in the uterine arteries  100  is effective to treat uterine fibroids  102  and other disease conditions of the uterus  90  and female reproductive organs. An angled tenaculum  12  may be useful in such treatments, by, for example, guiding clamps or other instruments configured to occlude a uterine artery  100  into position within a patient&#39;s vagina  92 , cervix  94 , and/or uterus  90 , and by, for example, serving as a guide to aid in the placement of an instrument and/or by providing a platform for stabilizing or holding such instruments in place during their use. Although a linear tenaculum  12  is shown in FIG. 5, it will be understood that an angled tenaculum  12  as illustrated in FIG. 1, and other tenacula embodying features of the invention may also be placed and used therein in a similar manner.  
         [0047]    In order to engage a tenaculum  12  with cervical tissue, distal tip  20  of a tenaculum sound  18  may be inserted without trauma into the cervical os  98 , providing a structure for guiding subsequent placement of a device  80  of a system  10 . Placement of a distal tip  20  of a sound  18  within a patient&#39;s cervix  94  serves to locate the angled tenaculum  12  in a position effective to guide the placement of pressure-applying elements  82  onto and around a cervix  94  so as to aid in the location and occlusion of uterine arteries  100  of a female patient. Pressure-applying elements  82  may be configured to release from a proximal portion of a device  80 , while retaining a secure attachment between pressure-applying elements  82  and a tenaculum  12  even after the release of pressure-applying elements  82  from the rest of device  80 .  
         [0048]    A device  80  may be attached to a tenaculum  12  before placement of a tenaculum within a patient&#39;s vagina  92 , for example, or may be attached at a later time, such as after a tenaculum  12  has been engaged with a patient&#39;s tissue. The secure engagement between tenaculum  12  and a cervix  94  may be used to pull, or otherwise maneuver, the cervix  94  as needed by the operator. For example, pulling on cervix  94  may be useful to place uterine arteries  100  into closer apposition to the vaginal formix  96  or uterus  90 , or both, and so to aid in subsequent compression of these arteries by a device  80  attached to a tenaculum  12 .  
         [0049]    Rotation of locking tube  34  so that threads  32  engaged with internal threads of locking tube  34  advance locking tube  34  may be effective to advance a locking tube  34 . Such advancement places distal collar portion  36  of locking tube  34  in contact with attachment sleeve  84 , pushing attachment sleeve  84  and connected device  80  in a distal direction. Such movement is effective to advance a device  80  towards target tissue when a system  10  is in place with a tenaculum  12  engaged with a patient&#39;s tissue. Such movement may be useful in methods for occluding uterine arteries  100 . For example, where a device  80  comprises a clamp with pressure-applying elements  82  configured to apply pressure to a cervix  94  or uterus  90 , such advancement is effective to place pressure-applying elements  82  in a suitable position within a female patient&#39;s vagina  92  so as to allow application of pressure-applying elements  82  for occlusion of the patient&#39;s uterine arteries  100 .  
         [0050]    A uterus  90  may be accessed via a vagina  92  and cervix  94 . A vagina  92  has a wall extending to form the vaginal formix  96  adjacent cervix  94 . Cervix  94  may be approached by medical instruments such as a tenaculum  12  as illustrated in FIG. 5, and/or a system  10  including an angled tenaculum  12  having features of the invention. Cervical os  98 , located at the apex of the cervix  94 , provides an opening into the uterus  90 . The uterus  90  is supplied with blood by the uterine arteries  100  and the ovarian arteries; it is believed that, in most women, the uterine arteries  100  provide the more significant fraction of the uterine blood supply. Thus, a major portion of the blood supply to the uterus  90  derives from the uterine arteries  100  which branch off the iliac arteries, and a smaller but often still significant portion of the uterine blood supply derives from the ovarian arteries which branch directly from the aorta.  
         [0051]    The uterine arteries  100  of female humans are typically disposed about 3 cm or less from the vaginal wall near the vaginal formix  96  where a uterine artery  100  meets the uterus  90 , although this distance between a uterine artery  100  and the uterus  90  may vary between patients. The cervix  94  can be used as a platform and a landmark from which to locate and access a uterine artery  100 . In addition, the uterus  90 , a muscular and generally firm mass, can be used as a backstop or anvil against which a uterine artery  100  can be compressed.  
         [0052]    [0052]FIG. 5 illustrates a linear tenaculum  12  in use and configured to grasp a cervix  94  of a female patient. The sound  18  is inserted into the cervical os  98  and the spike  22  is closed onto the cervix  94  to establish traction and hold on the cervix  94 . The spike  22  can be used on different portions of a cervix  94 , including on either the anterior or posterior lip of the cervix. Engagement of a spike  22  with tissue allows an operator to pull on or otherwise manipulate a patient&#39;s tissue with a tenaculum  12 . Such manipulation of a patient&#39;s tissue may be desirable to place the tissue in a desired position or orientation; for example, pulling on a cervix  94  extends the cervix  94  so as to provide a better configuration for placement of paddles  14  and for occlusion of uterine arteries. Pulling on a cervix  94  also stretches uterine arteries  100 , placing them closer to uterus  90  and in a favorable position for their occlusion by compression between vaginal formix  96  and uterus  90 . Lodgment of a closure pin  70  within a locking slot  72  in a closure sleeve  66  is effective to maintain engagement arm  24  and spike  22  of a linear tenaculum  12  in position so as to maintain the tissue configuration for as long as desired. Similarly, a ratchet  28  configured to lock handles  16  of an angled tenaculum  12  into a closed configuration is effective to maintain engagement arm  24  and spike  22  in position so as to maintain the tissue configuration for as long as desired.  
         [0053]    A deployable tenaculum  12  has a distal end  42  configured to engage and retain a cervix  94 , and a proximal end  44  which may have a handle  16 . The distal end  42  may be detached from the proximal end  44 , so as to remain engaged with a cervix  94  while detached from the proximal end  44 . During attachment and use, before detachment of the proximal  44  (handle) portion from the distal  42  (tissue-engaging) portion, at least part of the proximal portion  44  (e.g., a handle portion  16 ) may extend out from a patient&#39;s vagina, available to an operator. Where the linear tenaculum  12  is a deployable tenaculum, the distal  42  and proximal  44  portions may be disassembled after attachment of spike  22  with the cervix  94 . With the distal portion  42  of the linear tenaculum  12  firmly grasping the cervix  94 , the proximal portion  44  of the linear tenaculum  12  can then be removed from vagina  92 , leaving only the distal deployable portion  42  attached to the cervix  94  and within the vagina  92 . By removing the portion of the device that extends outside her body, detachment of the proximal portion  44  from the distal portion  42  allows greater comfort and freedom of movement to a patient during a procedure.  
         [0054]    The proximal portion  44  of the device  12  can be set aside and later used to retrieve the deployable distal portion  42  at the end of the procedure (e.g., after uterine artery occlusion has been achieved and maintained for a therapeutically effective time period). The ability to detachable a distal portion  42  allows for minimal bulk and discomfort within the vagina  92  relative to a non-deployable tenaculum  12 , and provides better visual access to an attending physician during a procedure following deployment. Thus, a deployable tenaculum having features of the invention is useful in any procedure requiring a tenaculum  12  where patient comfort or increased visual field are desired.  
         [0055]    A tenaculum  12  may be used to pull, stretch, and otherwise manipulate a cervix to aid in the application and use of a device  80 . For example, a device  80  may comprise a constrictor, such as a resilient form made of wire or other material configured to contact and to compress a cervix  94 . Deployment of such a device  80  may be aided by use of a tenaculum  12  to engage a cervix  94 . For example, an angled tenaculum  12  may be used to manipulate the cervix  94 , to reposition it or to apply tension to it during initial placement of a device  80 . A tenaculum  12  may be used to guide a delivery shaft carrying a device  80  within the vagina  92  so as to aid in the placement of a device  80  onto the cervix  94 , and to aid in the positioning of the device  80  for the duration of the occlusion of uterine arteries  100 .  
         [0056]    In embodiments of devices having features of the invention, a tenaculum sound  18  may be between about 1 inch and about 5 inches, preferably between about 1.5 inches and about 2.5 inches in length. A guide rail  30  may be between about 1 inch and about 12 inches long, and is preferably between about 3 inches and about 6 inches in length. In preferred embodiments of devices embodying features of the invention, a guide rail  30  may be between about 0.125 inches and about 0.25 inches in diameter. Handles  16  of an angled tenaculum  12  may lie generally along a line making an angle with a guide rail  30 , or may form an angle bisected by such a line, where the angle may be between about 10° and about 30°, preferably between about 15° and about 20°.  
         [0057]    A sound  18  and distal tip  20  may be made, at least in part, with materials such as silver, silver alloys, or other biocompatible materials. A sound  18  made at least in part with a silver or silver alloy, or of other biocompatible materials, may be flexible and or malleable, so that a clinician may readily adjust the tip to conform to the anatomy and clinical presentation of an individual patient if desired.  
         [0058]    In embodiments of devices having features of the invention, an engagement arm  24  may have a length of between about 1 and about 4 inches, preferably between about 2 to about 3 inches.  
         [0059]    Tenacula having features of the invention may be made from any suitable biocompatible, sterilizable material or combination of materials including stainless steel, shape memory alloys such as nickel titanium alloys, biocompatible and sterilizable thermoplastic and thermoset materials such as for example, polycarbonate, polyesters, modified polyurethanes, polyphenylene oxide, polysulfone, polyethylene, polyacetal, and other polymers and other biocompatible and preferably sterilizable metals, plastics, ceramics, and other materials suitable for making medical instruments known in the art. Devices and systems may be designed for single use (disposable) or may be sterilizable and capable of being used multiple times.  
         [0060]    While particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention to be defined by the scope of the appended claims as broadly as the prior art will permit, and in view of the specification if need be. Moreover, those skilled in the art will recognize that features shown in one embodiment may be utilized in other embodiments. Terms such a “element”, “member”, “device”, “sections”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the terms “means” or “step” followed by a particular function without specific structure or action. All patents and patent applications referred to above are hereby incorporated by reference in their entirety.