US20040097961A1 - Tenaculum for use with occlusion devices - Google Patents

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'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
• 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.[0001]
BACKGROUND OF THE INVENTION
• 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.[0002]
• 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.[0003]
• 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.[0004]
• 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.[0005]
• 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.[0006]
• 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.[0007]
• 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.[0008]
• 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.[0009]
SUMMARY OF THE INVENTION
• 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.[0010]
• 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.[0011]
• 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.[0012]
• 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.[0013]
• 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.[0014]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a perspective view of an angled tenaculum embodying features of the invention.[0015]
• FIG. 1B is a perspective view of a linear tenaculum embodying features of the invention with the retention element in a disengaged configuration.[0016]
• FIG. 1C is a longitudinal cross-sectional view of the deployable linear tenaculum illustrated in FIG. 1B taken along line[0017]1C-1C.
• FIG. 2A is a perspective view of a linear tenaculum embodying features of the invention with the retention element in an engaged configuration.[0018]
• FIG. 2B is a transverse cross-sectional view of the linear tenaculum illustrated in FIG. 2A taken along line[0019]2B-2B.
• 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.[0020]
• 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.[0021]
• FIG. 4A illustrates an angled tenaculum having features of the invention assembled with a medical instrument.[0022]
• FIG. 4B illustrates a linear tenaculum having features of the invention assembled with a medical instrument.[0023]
• 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.[0024]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The invention provides[0025]systems10, devices and methods for gripping and manipulating tissue. Atenaculum12 embodying features of the invention may be used alone to grip and manipulate tissue, or with other devices as part of asystem10 to provide a stable foundation for, e.g., the occlusion of uterine arteries in a female patient. Atenaculum12 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 oftenacula12 suitable for use in asystem10 having features of the invention include anangled tenaculum12 embodying features of the invention, as shown in FIG. 1A and alinear tenaculum12 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 anangled tenaculum12 may also apply to alinear tenaculum12 as well, and that tenaculum features and elements discussed with respect to alinear tenaculum12 may also apply to anangled tenaculum12.
• As shown in FIG. 1, a[0026]tenaculum12 has atenaculum shaft14 that may be connected with handle or handles16.Shaft14 has a distal portion comprising atenaculum sound18 with adistal tip20. Asound18 is preferably malleable or flexible, and may be resilient. Flexibility and malleability are useful, for example, in order to accommodate a patient's anatomy, including the orientation and disposition of a patient's cervix and cervical os. A sound18, and adistal tip20 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, adistal tip20 is preferably rounded in order to reduce the possibility of trauma to the cervix and to reduce possible discomfort to the patient assound18 is introduced into a cervix via a cervical os, enabling atenaculum12 to provide a structure for guiding subsequent placement of another device or devices of asystem10. In addition, asound18 anddistal tip20 may be sized, angled, finished, coated, or otherwise configured to reduce possible trauma and discomfort during use.
• A[0027]tenaculum12 may be secured in place by application of a retention element such as tenaculum spike22 into tissue so as to retain atenaculum12 in place. A retention element such asspike22 orspikes22 may be disposed on anengagement arm24 and configured to move into place so as to hold tissue. Aspike22 may be disposed so as to engage tissue, for example, when atenaculum12 is in place with asound18 within a cervical os, by movement ofengagement arm24 so as to place aspike22 into tissueadjacent sound18. Thus, for example, closure of tenaculum handles16 of an angled tenaculum12 (e.g., by pressing tenaculum handles16 closer together), rotatingengagement arm24 aroundpivot26 is effective to movespike22 towardssound18, and is effective to pressspike22 into tissue in a tissue-engaging configuration. Aspike22 pressed into cervical tissue is effective to retain atenaculum12 in place within a patient's vagina whensound18 is in place within a cervical os of a patient. Atenaculum12 may includemultiple spikes22. It will be understood that other retention elements configured to retain atenaculum12 in place within or on a patient's body, such as serrations, grooves, or other elements, may be used with or in place of aspike22. A retention element such as aspike22 may be held in a tissue-engaging configuration by alock mechanism28, such as a ratchet shown in FIG. 1A.
• A[0028]spike22, or other retention element, allows an operator to manipulate a patient's tissue with atenaculum12 by, for example, pulling on ahandle16 whenspike22 is engaged with tissue so that the tissue follows the movement of thetenaculum12. Such manipulation of a patient'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. Atenaculum12 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 atenaculum12.
• A[0029]shaft14 of anangled tenaculum12 may include aguide rail30 disposed proximal to sound18. Aguide rail30 may have a smooth outer surface or may havethreads32 on at least a portion of its length. Asound18 andguide rail30 are preferably collinear, and may comprise parts or ends of asingle shaft14.
• A locking[0030]tube34 may be attached to, or mounted on, aguide rail30. A lockingtube34 may be configured to engage aguide rail30 by having a distal collar portion36 (which preferably has a bore with internal threads) that is configured to engagethreads32 of aguide rail30. A lockingtube34 may also have aproximal portion38, which may be configured as a handle for manipulation by an operator, connected to thedistal collar portion36 by a connectingportion40. In preferred embodiments, a connectingportion40 is flexible; for example, a connectingportion40 may be a piece of flexible tubing sized to tightly engage the distal36 and proximal38 portions of a lockingtube34.
• An[0031]angled tenaculum12 embodying features of the invention may have a pair ofhandles16, or may have ahandle16 comprising only a single handle portion. Alinear tenaculum12 typically has asingle handle portion16. Alinear tenaculum12 may have ashaft14 including adistal portion42 and aproximal portion44.Sound18 withdistal tip20 is typically collinear withshaft14 of alinear tenaculum12. Ahandle16 may be attached to aproximal portion44 of alinear tenaculum12; alternatively, aproximal portion44 may serve as ahandle16 when held by an operator. In either case, ashaft14 of alinear tenaculum12, or portions thereof, may serve as aguide rail30.
• A[0032]linear tenaculum12 having features of the invention may comprise multiple shafts or tube assembled together to form ashaft14. For example, as illustrated in FIG. 1C, ashaft14 of alinear tenaculum12 may comprise abolt46 having bolt threads48 on at least a distal portion, aproximal body tube50 and adistal body tube52 having inner threads54 complementary to bolt threads48. Aproximal body tube50 may be configured to engage adistal body tube52 by, for example, having adistal end56 comprising a lip58 with a stop60. The lip58 of aproximal body tube50 may be configured to accept a portion of adistal body tube52, and the stop60 may be configured to regulate the length ofdistal body tube52 held within lip58. Anouter tube62 may be disposed aroundproximal body tube50 and configured to move longitudinally alongshaft14.
• A retention element such as a[0033]spike22 oflinear tenaculum12 is disposed on anengagement arm24 which may be connected toshaft14 at a joint64. In preferred embodiments, a joint64 is a fixed point of attachment betweenengagement arm24 andshaft14; movement of retention element such asspike22 towardsshaft14 is enabled by the flexibility of at least a portion ofengagement arm24. Alternatively, joint64 may comprise a pivot, a spring, a flexible sleeve, or other form of flexible attachment mechanism to joinengagement arm24 withshaft14. Closure ofengagement arm24, effective to movespike22 near toshaft14 andsound18 for engagement with tissue, may be effected, for example, by distal movement ofhandle16, causing distal movement of a closure element such as aclosure sleeve66 disposed aboutshaft14 so as to press on joint64 so as to movespike22 towardsshaft14. Alinear tenaculum12, as illustrated in FIGS. 1 and 2 provides the advantage of a much lower profile than, for example, anangled tenaculum12 as illustrated in FIG. 1. A lower profile may be advantageous during use within a patient'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.
• An engagement arm[0034]24 (carrying a spike22) is preferably a flexible arm, and is preferably fixedly joined toshaft14 at a joint64. As illustrated in the Figures, joint64 may be a depression, such as a “D”-shaped slot in around shaft14, into which a complementarily-shapedend68 ofengagement arm24 is fitted.End68 may be welded, pinned, glued, or otherwise fixedly attached toshaft14. Anengagement arm24 may be made with metal, such as stainless steel, or other durable, flexible material, including polymers. Alternatively, a joint64 may include a spring, or a hinged joint, or both.
• A[0035]spike22 disposed on portions ofengagement arm24 may be moved closer toshaft14 by pressure effective to flex engagement arm towardsshaft14 effective to place it in a tissue-engaging configuration. For example, aclosure sleeve66 may be disposed aroundshaft14, preferably outsideproximal body tube50 and configured to move (e.g., slide) longitudinally alongproximal body tube50. In embodiments of the invention, anouter tube62 may have a distal end configured to engage aclosure sleeve66 effective to cause it to move longitudinally alongproximal body tube50.
• A[0036]closure sleeve66 held in place by aclosure pin70, pressing on anengagement arm24 is effective to close and retainengagement arm24 in a closed configuration. Anengagement arm24 having aspike22 disposed in such a closed configuration and in contact with tissue is effective to grip tissue and to retain atenaculum12 in place engaged with the tissue.
• A[0037]closure sleeve66 may be locked into place so as to maintain aspike22 in a tissue-engaging configuration. Aclosure sleeve66 may have alocking slot72 configured to accept aclosure pin70. For example, aclosure pin70 attached toshaft14 may be lodged within a lockingslot72 so as to hold aclosure sleeve66 in a configuration thatcontacts engagement arm24 so as to place aspike22 into a tissue-engaging configuration. Aclosure pin70 is preferably disposed ondistal shaft portion42, preferably ondistal body tube52. Preferably, a lockingslot72 has a non-linear shape, including, for example, a bend such as a right-angled bend, so that a lockingslot72 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 aclosure pin70 and constrain aclosure sleeve66 from further longitudinal motion after lodgment ofclosure pin70 within lockingslot72. Such lodgment may be obtained, for example, by longitudinal movement ofclosure sleeve66 so as to bring aclosure pin70 within a longitudinal portion of a lockingslot72, followed by rotational movement ofclosure sleeve66 so as to placeclosure pin70 within a latitudinal portion of the lockingslot72.
• A[0038]closure sleeve66 may be moved into place by distal movement of anouter body tube62 disposed aroundproximal body tube50. Adistal portion74 ofouter body tube62 is preferably configured to engage with aproximal portion76 of aclosure sleeve66 so as to transmit both longitudinal and rotational motion from theouter body tube62 to theclosure sleeve66. For example, adistal portion74 may have a step or steps configured to engage a complementary step or steps of aproximal portion76 as illustrated in FIGS. 1 and 2, effective to allow rotation of anouter body tube62 to be transferred to aclosure sleeve66. As discussed above, such rotational motion of closure sleeve may be effective to lodge aclosure pin70 within a lockingslot72.
• 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[0039]angled tenaculum12 as illustrated in FIG. 3A may havedetachable handles16 configured for detachment from, and re-attachment to, a distal portion ofangled tenaculum12 that includespivot26,engagement arm24, spike22, andsound18. The detachable distal portion may thus be deployed while engaged with tissue, and remain engaged with tissue, after detachment ofhandles16.Handles16 may be re-attached at a later time if desired, and may, for example, aid in removal of the distal portion from the patient's tissue.
• In embodiments of tenacula having features of the invention, a[0040]linear tenaculum12 may be configured to disassemble into a separatedistal portion42 and a separateproximal portion44. Such separation allows the removal ofproximal portion44 from within a patient's body whiledistal portion42 remains in place during use. As illustrated in FIG. 3B, aspike22 andengagement arm24 may be retained in a tissue-engaging configuration after deployment of thedistal portion42 by locking aclosure sleeve66 into place with aclosure pin70 lodged within lockingslot72.
• FIG. 3B provides a perspective view of a deployable[0041]linear tenaculum12, including adistal portion42 and aproximal portion44 of a disassembled deployablelinear tenaculum12.Portions42 and44 of alinear tenaculum12 may be held together by abolt46, with a portion ofdistal body tube52 held within a lip58. Alternatively, adistal portion42 ofshaft14 may be attached with aproximal portion44 ofshaft14 by a lip58 anddistal body tube52 having complementary threads configured to form a threaded attachment. Thus, for example,distal portion42 may be attached toproximal portion44 by screwing the portions together, anddistal portion42 may be detached fromproximal portion44 by unscrewing the portions.
• Thus, a deployable linear tenaculum may have a sound[0042]18 for entry into the cervical os, ashaft14 for manipulating and controlling the cervix, aspike22 for grasping the cervix disposed on anengagement arm24, a mechanism to open and close the spike22 (such as a joint64 configured to be operated byclosure sleeve66 disposed around shaft14), and a mechanism to deploy the distal portion42 (such as by unscrewing bolt46). An advantage of atenaculum12 having a deployabledistal portion42 over other configurations oftenacula12 having features of the invention is that the deployeddistal portion42 may be fully contained within the vagina and uterus of the patient during use after deployment. The deployabledistal portion42 may serve as a guide and/or as a base or mounting element for the use with other instruments.
• [0043]Systems10 including anangled tenaculum12 and alinear tenaculum12 engaged with other instruments are illustrated in FIGS. 4A and 4B respectively. Other instruments suitable for use with atenaculum12 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 asystem10 with atenaculum12 having features of the invention, one example of such an instrument is anocclusion device80 with pressure-applyingelements82 as illustrated in FIGS. 4A and 4B. Asystem10 including anangled tenaculum12 and adevice80 is illustrated in FIG. 4A; asystem10 including alinear tenaculum12 and adevice80 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.
• A[0044]device80 may be operatively connected with a tenaculum by anattachment sleeve84, which may be configured to at least partially surround or enclose a portion ofguide rail30. Anattachment sleeve84 may be configured to engage aguide rail30 effective that anattachment sleeve84 may slide longitudinally along theguide rail30. Anattachment sleeve84 is preferably configured to slide along portions of aguide rail30 having a smooth outer surface and to slide along portions of aguide rail30 havingthreads32. Such sliding movement of anattachment sleeve84 carriesdevice80 along the path defined byguide rail30 oftenaculum12. Thus, engagement of anattachment sleeve84 with aguide rail30 is effective to guide and direct the movement of adevice80 by atenaculum12. Where lockingtube34 is not moved, or where it is locked into a position, such engagement between anattachment sleeve84 of adevice80 is effective to immobilize and retaindevice80 with respect to atenaculum12.
• A[0045]tenaculum12 may engage a patient's tissue; thus, where adevice80 is engaged with atenaculum12, the positioning and movement of adevice80 relative to a patient's tissue may be guided and directed by atenaculum12. For example, the advancement of a lockingtube34 effective to pressdistal collar portion36 of lockingtube34 againstattachment sleeve84 is effective to advanceattachment sleeve84 distally, and thereby also movingdevice80 and pressure-applyingelements82 in a distal direction. Advancement of anouter tube62 distally along ashaft14 of alinear tenaculum12 is similarly effective to advance anattachment sleeve84 distally, and thereby to move adevice80 and pressure-applyingelements82 in a distal direction. Such distal movement may be useful, for example, to advance adevice80 towards a cervix where adevice80 is mounted on atenaculum12 is engaged with cervical tissue.
• A schematic diagram of female human reproductive anatomy and related structures is shown in FIG. 5, illustrating the placement and use therein of a[0046]tenaculum12 embodying features of the invention. The anatomical features shown in FIG. 5 includeuterus90,vagina92,cervix94,vaginal formix96,cervical os98, and uterine arteries100 (which provide a large fraction of the uterine blood supply). Auterine fibroid102 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. (“'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 theuterine arteries100 is effective to treatuterine fibroids102 and other disease conditions of theuterus90 and female reproductive organs. Anangled tenaculum12 may be useful in such treatments, by, for example, guiding clamps or other instruments configured to occlude auterine artery100 into position within a patient'svagina92,cervix94, and/oruterus90, 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 alinear tenaculum12 is shown in FIG. 5, it will be understood that anangled tenaculum12 as illustrated in FIG. 1, and other tenacula embodying features of the invention may also be placed and used therein in a similar manner.
• In order to engage a[0047]tenaculum12 with cervical tissue,distal tip20 of atenaculum sound18 may be inserted without trauma into thecervical os98, providing a structure for guiding subsequent placement of adevice80 of asystem10. Placement of adistal tip20 of asound18 within a patient'scervix94 serves to locate theangled tenaculum12 in a position effective to guide the placement of pressure-applyingelements82 onto and around acervix94 so as to aid in the location and occlusion ofuterine arteries100 of a female patient. Pressure-applyingelements82 may be configured to release from a proximal portion of adevice80, while retaining a secure attachment between pressure-applyingelements82 and atenaculum12 even after the release of pressure-applyingelements82 from the rest ofdevice80.
• A[0048]device80 may be attached to atenaculum12 before placement of a tenaculum within a patient'svagina92, for example, or may be attached at a later time, such as after atenaculum12 has been engaged with a patient's tissue. The secure engagement betweentenaculum12 and a cervix94 may be used to pull, or otherwise maneuver, the cervix94 as needed by the operator. For example, pulling oncervix94 may be useful to placeuterine arteries100 into closer apposition to thevaginal formix96 oruterus90, or both, and so to aid in subsequent compression of these arteries by adevice80 attached to atenaculum12.
• Rotation of locking[0049]tube34 so thatthreads32 engaged with internal threads of lockingtube34advance locking tube34 may be effective to advance a lockingtube34. Such advancement placesdistal collar portion36 of lockingtube34 in contact withattachment sleeve84, pushingattachment sleeve84 and connecteddevice80 in a distal direction. Such movement is effective to advance adevice80 towards target tissue when asystem10 is in place with atenaculum12 engaged with a patient's tissue. Such movement may be useful in methods for occludinguterine arteries100. For example, where adevice80 comprises a clamp with pressure-applyingelements82 configured to apply pressure to a cervix94 oruterus90, such advancement is effective to place pressure-applyingelements82 in a suitable position within a female patient'svagina92 so as to allow application of pressure-applyingelements82 for occlusion of the patient'suterine arteries100.
• A[0050]uterus90 may be accessed via avagina92 andcervix94. Avagina92 has a wall extending to form thevaginal formix96adjacent cervix94.Cervix94 may be approached by medical instruments such as atenaculum12 as illustrated in FIG. 5, and/or asystem10 including anangled tenaculum12 having features of the invention.Cervical os98, located at the apex of the cervix94, provides an opening into theuterus90. Theuterus90 is supplied with blood by theuterine arteries100 and the ovarian arteries; it is believed that, in most women, theuterine arteries100 provide the more significant fraction of the uterine blood supply. Thus, a major portion of the blood supply to theuterus90 derives from theuterine arteries100 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.
• The[0051]uterine arteries100 of female humans are typically disposed about 3 cm or less from the vaginal wall near thevaginal formix96 where auterine artery100 meets theuterus90, although this distance between auterine artery100 and theuterus90 may vary between patients. The cervix94 can be used as a platform and a landmark from which to locate and access auterine artery100. In addition, theuterus90, a muscular and generally firm mass, can be used as a backstop or anvil against which auterine artery100 can be compressed.
• FIG. 5 illustrates a[0052]linear tenaculum12 in use and configured to grasp acervix94 of a female patient. Thesound18 is inserted into thecervical os98 and thespike22 is closed onto the cervix94 to establish traction and hold on thecervix94. Thespike22 can be used on different portions of a cervix94, including on either the anterior or posterior lip of the cervix. Engagement of aspike22 with tissue allows an operator to pull on or otherwise manipulate a patient's tissue with atenaculum12. Such manipulation of a patient's tissue may be desirable to place the tissue in a desired position or orientation; for example, pulling on acervix94 extends the cervix94 so as to provide a better configuration for placement ofpaddles14 and for occlusion of uterine arteries. Pulling on a cervix94 also stretchesuterine arteries100, placing them closer touterus90 and in a favorable position for their occlusion by compression between vaginal formix96 anduterus90. Lodgment of aclosure pin70 within a lockingslot72 in aclosure sleeve66 is effective to maintainengagement arm24 and spike22 of alinear tenaculum12 in position so as to maintain the tissue configuration for as long as desired. Similarly, aratchet28 configured to lockhandles16 of anangled tenaculum12 into a closed configuration is effective to maintainengagement arm24 and spike22 in position so as to maintain the tissue configuration for as long as desired.
• A[0053]deployable tenaculum12 has adistal end42 configured to engage and retain acervix94, and aproximal end44 which may have ahandle16. Thedistal end42 may be detached from theproximal end44, so as to remain engaged with a cervix94 while detached from theproximal end44. During attachment and use, before detachment of the proximal44 (handle) portion from the distal42 (tissue-engaging) portion, at least part of the proximal portion44 (e.g., a handle portion16) may extend out from a patient's vagina, available to an operator. Where thelinear tenaculum12 is a deployable tenaculum, the distal42 and proximal44 portions may be disassembled after attachment ofspike22 with thecervix94. With thedistal portion42 of thelinear tenaculum12 firmly grasping thecervix94, theproximal portion44 of thelinear tenaculum12 can then be removed fromvagina92, leaving only the distaldeployable portion42 attached to the cervix94 and within thevagina92. By removing the portion of the device that extends outside her body, detachment of theproximal portion44 from thedistal portion42 allows greater comfort and freedom of movement to a patient during a procedure.
• The[0054]proximal portion44 of thedevice12 can be set aside and later used to retrieve the deployabledistal portion42 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 adistal portion42 allows for minimal bulk and discomfort within thevagina92 relative to anon-deployable tenaculum12, 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 atenaculum12 where patient comfort or increased visual field are desired.
• A[0055]tenaculum12 may be used to pull, stretch, and otherwise manipulate a cervix to aid in the application and use of adevice80. For example, adevice80 may comprise a constrictor, such as a resilient form made of wire or other material configured to contact and to compress acervix94. Deployment of such adevice80 may be aided by use of atenaculum12 to engage acervix94. For example, anangled tenaculum12 may be used to manipulate the cervix94, to reposition it or to apply tension to it during initial placement of adevice80. Atenaculum12 may be used to guide a delivery shaft carrying adevice80 within thevagina92 so as to aid in the placement of adevice80 onto thecervix94, and to aid in the positioning of thedevice80 for the duration of the occlusion ofuterine arteries100.
• In embodiments of devices having features of the invention, a[0056]tenaculum sound18 may be between about 1 inch and about 5 inches, preferably between about 1.5 inches and about 2.5 inches in length. Aguide rail30 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, aguide rail30 may be between about 0.125 inches and about 0.25 inches in diameter.Handles16 of anangled tenaculum12 may lie generally along a line making an angle with aguide rail30, 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°.
• A[0057]sound18 anddistal tip20 may be made, at least in part, with materials such as silver, silver alloys, or other biocompatible materials. A sound18 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.
• In embodiments of devices having features of the invention, an[0058]engagement arm24 may have a length of between about 1 and about 4 inches, preferably between about 2 to about 3 inches.
• 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.[0059]
• 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.[0060]

Claims (32)

What is claimed is:

1. A hand-held device for use with medical instruments and for manipulating tissue of a female patient having a cervix and a cervical os, comprising:

an elongated shaft with a proximal portion and a distal portion defining a longitudinal direction along a longitudinal axis, said distal portion having a distal tip configured for atraumatic entry into said cervical os;

a tissue retention element operatively attached to said elongated shaft and configured to grip tissue when said shaft distal tip is disposed within said cervical os; and

a guide rail portion of said device configured to engage a medical instrument.

2. The tissue manipulating device ofclaim 1, wherein said elongated shaft distal tip comprises a rounded tip.

3. The tissue manipulating device ofclaim 1, wherein said distal portion of said elongated shaft comprises a malleable material.

4. The tissue manipulating device ofclaim 3, wherein said malleable material comprises a soft metal.

5. The tissue manipulating device ofclaim 4, wherein said soft metal comprises silver.

6. The tissue manipulating device ofclaim 1, wherein said tissue retention element comprises an elongated arm, and wherein said operative attachment comprises a flexible connection between said elongated arm and said elongated shaft.

7. The tissue manipulating device ofclaim 6, further comprising a closure element configured to press said elongated arm towards said elongated shaft.

8. The tissue manipulating device ofclaim 7, wherein said closure element is configured to move longitudinally along said elongated shaft effective to press said elongated arm towards said elongated shaft.

9. The tissue manipulating device ofclaim 6, wherein said elongated arm comprises a flexible portion, and said operative attachment comprises a fixed attachment between said elongated arm and said elongated shaft.

10. The tissue manipulating device ofclaim 6, wherein said operative attachment comprises a pivot.

11. The tissue manipulating device ofclaim 1, further comprising a securing element configured to secure said retention element so as to maintain the retention element in contact with tissue when said distal tip is disposed within said cervical os.

12. The tissue manipulating device ofclaim 1, wherein said retention element comprises a sharp point.

13. The tissue manipulation device ofclaim 6, wherein said guide rail portion is configured to receive a slidable coupling element attached to a medical device, said slidable coupling element being configured to move in a longitudinal direction along said guide rail portion effective to guide the motion of said medical device.

14. The tissue manipulating device ofclaim 6, further comprising a collar configured to move in a longitudinal direction along said guide rail portion.

15. The tissue manipulating device ofclaim 14, wherein said guide rail portion and said collar each comprise complementary threads configured to operatively engage with each other effective that engagement of said threads and rotation of said collar around said longitudinal axis is effective to provide longitudinal movement of said collar along said guide rail portion.

16. The tissue manipulating device ofclaim 15, wherein said collar is configured to contact said slidable coupling element effective that longitudinal movement of said collar towards said slidable coupling element when said collar is in contact with said slidable coupling element is effective to effect longitudinal movement of said slidable coupling element.

17. The tissue manipulating device ofclaim 1, further comprising a handle.

18. The tissue manipulating device ofclaim 17, wherein said handle comprises two pivotally-connected portions configured for engagement by a human hand.

19. The tissue manipulating device ofclaim 17, wherein said handle comprises a substantially cylindrical shaft.

20. The tissue manipulating device ofclaim 19, wherein said handle comprises a proximal portion of said elongated shaft.

21. The tissue manipulating device ofclaim 1, comprising a proximal portion and a distal portion, wherein said distal portion of said elongated shaft is configured to separate from said proximal portion of said device.

22. The tissue manipulating device ofclaim 21, wherein said distal portion is configured to be retained in tissue when said portions are separated following engagement of said retention element with tissue.

23. A system for manipulating tissue of a female patient having a cervix and a cervical os, comprising:

a) a hand-held device for use with medical instruments and for manipulating tissue of a female patient having a cervix and a cervical os, comprising:

an elongated shaft with a proximal portion and a distal portion defining a longitudinal direction along a longitudinal axis, said distal portion having a distal tip configured for atraumatic entry into said cervical os;

a tissue retention element operatively attached to said elongated shaft and configured to grip tissue when said shaft distal tip is disposed within said cervical os;

and a guide rail portion of said device configured to engage a medical instrument; and

b) a medical instrument having a slidable coupling element configured to engage said guide rail portion of said device.

24. The system for manipulating tissue of a female patient ofclaim 23, wherein said slidable coupling element is configured to move along said longitudinal direction.

25. A hand-held device for use with a medical instrument and for manipulating tissue of a female patient having a cervix and a cervical os, comprising:

a positioning means for atraumatic positioning of said device adjacent said cervical os;

a tissue retention means configured to grip tissue; and

a guide means configured to engage a medical instrument.

26. The device ofclaim 1, wherein said distal portion having a distal tip configured for atraumatic entry into said cervical os comprises a length of between about 1 inch and about 5 inches.

27. The device ofclaim 26, wherein said distal portion having a distal tip configured for atraumatic entry into said cervical os comprises a length of between about 1.5 inches and about 2.5 inches.

28. The device ofclaim 1, wherein said guide rail comprises a length of between about 1 inch and about 12 inches.

29. The device ofclaim 28, wherein said guide rail comprises a length of between about 3 inches and about 6 inches.

30. The device ofclaim 1, wherein said guide rail comprises a diameter of between about 0.125 inch and about 0.25 inch.

31. The device ofclaim 6, wherein said elongated arm comprises a length of between about 1 inch and about 4 inches.

32. The device ofclaim 31, wherein said elongated arm comprises a length of between about 2 inches and about 3 inches.

Images