Abstract:
Apparatuses and methods for performing a procedure on a uterine cavity of a patient are disclosed. The methods can include visualizing the uterine cavity, biopsying a tissue with a biopsy device, and ejecting fluid from the biopsying device into the uterine cavity. The apparatuses can have a sealable acorn tip, a handle, a repositioning clip, a distal indicia, a proximal indicia, and a fluid reservoir. The biopsying device can be configured to biopsy and eject fluid under the control of a single hand of a user of the device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional application of U.S. patent application Ser. No. 13/830,202, filed Mar. 14, 2013, which claims the benefit of U.S. Provisional Application No. 61/723,114, filed 6 Nov. 2012, both of which are incorporated by reference herein in their entireties. 
     
    
     FIELD OF THE DISCLOSURE 
       [0002]    The present disclosure generally relates to procedures for assessing bodily cavities such as the uterine cavity, Such procedures utilize ultrasonography and the removal of bodily tissue for further pathological analysis. Methods for the assessment of the uterine cavity and endometrial lining of the uterus can be performed by the devices disclosed herein. Methods of the delivery of drugs, agents, and therapeutic devices in targeted locations of the uterus are disclosed herein, Methods for performing an endometrial biopsy and saline infusion sonography (SIS) in a simplified fashion that can enable the physician to perform these procedures while simultaneously operating ultrasonographic probes are disclosed. 
       BACKGROUND 
       [0003]    In gynecological, practice, it is standard for women to undergo procedures to assess their uterine cavities and the endometrial tissue, in particular for woman suffering from abnormal bleeding., infertility, suspected cancer, sexually transmitted diseases, pelvic pain, and other maladies of the reproductive tract. These procedures include making an assessment of the uterine cavity with or without saline infusion, assessing the patency of the fallopian tubes, determining the thickness of endometrial lining as per the time of the woman&#39;s cycle, examining for uterine abnormalities such as polyps, adhesions, and fibroids within the cavity or wall of the uterus, and performing an biopsy of the uterine lining. As part of the work up, these standard procedures typically are performed in an office setting or small suite without the use of anesthesia for the patient. Since these procedures are typical in the gynecological work up of a patient, a gynecologist could be expected to perform many assessments of the uterine cavity during the course of patient consultations and visits. 
         [0004]    Specifically during a uterine cavity assessment, the gynecologist will access the cervix through the vagina by utilizing a speculum. The gynecologist may or may not use a tenaculum to stabilize or straighten the cervical canal depending upon the anatomy and physician preference. For greater patient comfort, the gynecologist seeks to reduce the amount of materials that enter the patient&#39;s vagina as well as minimize the number of times different devices need to be inserted within the patient. Patient comfort is further enhanced by a reduced procedural time and due to capitated fee structures and scheduling constraints, the gynecologist also is incentivized to reduce procedural time yet obtaining a proper and efficient diagnosis is paramount. 
         [0005]    Using either a vaginal or abdominal ultrasonographic probe, a general assessment of the uterus and surrounding organs can be performed. In an effort to simplify the assessment of the uterine cavity, gynecologists have incorporated the use of saline infusion to distend the cavity and provide further contrast for the detection of uterine cavity abnormalities. The continued injection of saline with or without the use of Doppler ultrasound can provide further information. on fallopian tube patency if a spill or free flow of saline in the peritoneal space can be visualized by ultrasound in some cases the saline can be enhanced for ultrasonography if bubbles or foams are incorporated into the saline fluid. In an effort for further echogenicity, the saline can be replaced by gels that are known to have higher contrast for ultrasonographic detection. 
         [0006]    To perform these infusions, gynecologists have employed a variety of catheter tools and many of these devices are indicated for other procedures. For instance, it is standard practice for physicians to use insemination catheters for the infusion of saline into the uterine cavity since these devices are small in diameter or profile, do not require cervical dilation, and they are readily available in the gynecologist&#39;s practice. These insemination catheters are typically characterized as single lumen catheters with a smooth distal end opening, flexible shaft, indicia for uterine depth markings in centimeter increments, and a proximal liter connector or coupling for connecting a syringe or fluid source. These simple catheters have no ability to improve the distension of the uterine cavity during infusion and in a majority of cases, especially in multi-parous women, a significant amount of the fluid will escape through the cervical canal. 
         [0007]    Other catheters have been developed that improve the infusion of saline through the incorporation of means for blocking or sealing the cervical canal. These catheters also have applications for the fluoroscopic or x-ray assessment of the uterine cavity in a procedure known as hysterosalpingography whereby contrast agents and fluids are injected into the uterine cavity and fallopian tubes for assessment for radiographic techniques. In one form, these catheters have balloons on their distal ends which seal the cervical canal within the lower uterine segment. Following insertion in to the uterine cavity, these distal balloons are inflated and pulled back proximally to allow for the balloon to engage and seal within the lower uterus at the upper endocervical canal, Once pulled into and pressed into the endocervix, the balloon provides a seal for the distension of the uterine cavity. These distal balloons can obscure the lower uterine cavity region from ultrasonographic analysis. 
         [0008]    Other catheters have acorn or bulbous tips near their distal end. The purpose of these acorn tips is to occlude the exocervix and thereby maintain pressure or distension in the uterine cavity. In practice the gynecologist presses the acorn tip into and against the exocervix to occlude the cervical opening to improve uterine distension. These acorn tips have conic in a variety of shapes and sizes. Typically they are not efficient in providing an adequate seal in most women since the exocervix in women can be highly irregular. Some systems have utilized a tenaculum to provide a compressive force to help stabilize and enforce the pressure of the acorn tip against the exocervix. In practice this combination can be uncomfortable for the patient, especially during the manual injection of fluids or saline into the uterine cavity. 
         [0009]    During the gynecological assessment of the uterine cavity, it is desirable to obtain a portion of tissue for pathological analysis. Some devices incorporate the use of vacuum at the distal tip (e.g., PIPELLE® manufactured by Cooper Surgical, Inc. of Trumbull, Conn.). These devices may utilize an inner mandrel that is withdrawn proximally by the physician to create a vacuum force. The vacuum force draws fluid and tissue into the distal opening of the catheter within the uterus. Once removed from the uterine cavity, the distal catheter is placed into a specimen container and the inner mandrel is advanced to expel the contents collected in the distal end into the specimen container. 
         [0010]    Another biopsy device utilizes a brush within the inner catheter that is advanced from the distal end of the catheter which is placed within the uterine cavity. The brush (e.g., TAO BRUSH™ manufactured by Cook Medical, Inc of Bloomington, Ind.) is advanced from the distal end of the catheter. The brush is typically rotated in situ to increase the amount of contact with the tissue in the uterine cavity. After several rotations the brush is withdrawn back into the distal end of the catheter and the entire device is removed from the uterus and body of the patient. Once removed, the inner brush is advanced beyond the distal end of the catheter within a specimen container partially filled with fluid or saline. The brush is agitated within the fluid so that tissue on the brush can be released into the fluid so that the specimen container can be processed by the pathologist. 
         [0011]    Both of these biopsy devices typically collect tissue without visualization and the devices provide no means for determining their location with the use or ultrasound or radiographic. techniques. Thereby the location of the biopsy sample is not known. 
         [0012]    Several researchers have sought to simplify the combination of ultrasonography and pathological analysis in the uterine cavity by reducing the number of devices required for insertion in the practice setting. The device e.g., GOLDSTEIN CATHETER™ manufactured by Cook Medical, Inc of Bloomington, Ind.) can employ a single catheter lumen, a distal opening, a distal shaft with indicia for depth markings, a slideable acorn tip, a proximal coupling, used for both the injection of fluid such as saline from the distal end opening, and a vacuum source such as a syringe that will cause fluid and tissue to be withdrawn into the distal opening. In practice, the physician has to simultaneously maintain uterine cavity position and distension with the acorn tip, while manipulating a syringe at the proximal end. In this situation, the physician cannot also operate the ultrasound probe and equipment and would need the assistance of a nurse and technician. In addition, to operate the biopsy mechanism, vacuum needs to he employed within the inner catheter thereby removing all distension and visibility in the uterine cavity. Also, with a vacuum force at the distal end of the catheter, the ability to re-position or re-direct the location of the distal end of the catheter, and what tissue is being collected, is significantly minimized. 
         [0013]    In U.S. Pat. No. 8,157,745 to Schoot, which is incorporated b reference herein in its entirety, a method and apparatus is described that combines features of a saline infusion system and a biopsy device that withdraws tissue and fluid within its distal end opening by the withdrawal of an inner mandrel. In Schoot, an acorn tip is fixed to an outer catheter with an inner, slideable, concentric catheter. Within the inner catheter is housed an inner mandrel configured to provide a vacuum force once withdrawn by the physician from at the proximal end. The Shoot system provides a saline source. Using the Schoot device, the physician has to simultaneously maintain uterine cavity position and distension with the acorn tip, while manipulating the withdrawal of the inner mandrel within the inner catheter at the proximal end. In this situation, the physician cannot also operate the ultrasound probe and equipment and would need the assistance of a nurse and technician. In addition, to operate the biopsy mechanism, vacuum is created by withdrawing the inner mandrel and this action removes all distension and visibility in the uterine cavity. Also, with a vacuum force at the distal end of the catheter, the ability to re-position or re-direct the location of the distal end of the catheter, and what tissue is being collected, is significantly minimized. 
         [0014]    In practice, it would be beneficial to the physician to have a simplified system that could perform uterine cavity assessments without the need for further technicians, assistants, nurses or manpower, yet maintain a high quality diagnosis. For uterine cavity distension, it would be beneficial if the sealing mechanism of the exocervix was improved. In addition, it would be beneficial if the biopsy system could be easily directed and visualized to allow for targeted collection of tissue. 
       SUMMARY OF THE INVENTION 
       [0015]    A method of performing a procedure on a uterine cavity of a patient is disclosed. The method can include visualizing, the uterine cavity, biopsying a tissue with a biopsy device, and ejecting fluid from the biopsying device into the uterine cavity. 
         [0016]    The biopsying can include at least one of advancing, rotating, and withdrawing the biopsy device into the uterine cavity. The biopsy device can have a sealable tip on a repositionable component, proximal indicia and distal indicia. The biopsying device can be configured to biopsy and eject fluid under the control of a single hand of a user of the device. 
         [0017]    An apparatus for performing a procedure on a uterine cavity of a patient is also disclosed. The apparatus can have a sealable acorn tip, a handle, a repositioning clip, a distal indicia, a proximal indicia, and a fluid reservoir. The handle can have a pumping lever and a biopsy instrument. The biopsy instrument can be configured to translate and rotate with respect to the handle. 
         [0018]    A further apparatus for performing a procedure on a uterine cavity of a patient is disclosed. The apparatus can have an elongated member, a sealable tip, a handle, a repositioning clip, a distal indicial, a proximal indicia, a fluid reservoir; and a vaginal ultrasound probe. The probe can have a rotatable clip attached to at least one of the elongated member and the handle. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1  illustrates one example of a device, not the invention, within the cross-section of a uterine cavity. 
           [0020]      FIGS. 2   a,    2   b,    2   c,  and  2   d  illustrate examples of acorn tips, not the invention, engaging a cross-section view of an exocervix of a patient. 
           [0021]      FIGS. 3   a  and  3   b  illustrate one configuration of a new sealable acorn tip in a cross-sectional view of a uterine cavity of a patient. 
           [0022]      FIGS. 4   a  and  4   b  illustrate one configuration of a device for performing simultaneous sonography and biopsy with partial cross sectional views. 
           [0023]      FIGS. 5   a  and  5   b  illustrate one configuration of an apparatus for performing simultaneous sonography and biopsy that engages a vaginal ultrasound probe during a uterine cavity assessment. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    In  FIG. 1  illustrates a device I within a cross-sectional view of the uterine cavity  20 . The distal end of the device  3  is shown with a distal end opening  4 , inner lumen  6 , and indicia  5  for determining the depth of insertion within the uterine cavity using, the exocervix  30  of the cervix or endocervical canal  31  as a frame of reference. Located at the exocervical opening  30 , an acorn tip  50  is placed and pressed into the exocervical opening  30  to provide a seal for media within the uterine cavity  20 . A connector or coupling  60  can be located on the proximal end of the device  1 . This coupling  60  can be configured as a stopcock, T-connector or Y-connector to allow for the injection of fluids or media into connector opening  61 . This connector opening  61  can be configured as a luer connector to allow for the connection of a syringe  63  or other fluid supplying source. In operation the syringe  63  or other fluid supplying source  64  can be used to distend the uterine cavity  20  when performing an ultrasonographic or radiographic examination of the uterine cavity. Ultrasonography and radiographic equipment are not shown. From connector opening  61 , a syringe  63  or other vacuum supplying source can be can be connected to supply negative pressure within the inner lumen  6  of device  1  to withdraw fluid and tissue from the uterine cavity within the distal end opening  4 . 
         [0025]    The acorn tip  50  can be positioned at the exocervical opening  30 . The acorn tip  50  can be configured in a conical shape with smaller diameter distal end  51  and larger diameter proximal end  52 . The acorn tip  50  can be slid or re-positioned on distal end of the device  3  to correspond to the desired depth of insertion as indicated by the indicia  5 . In practice, a physician may perform a scout film of the uterine cavity  20  by use of the ultrasonographic or radiographic equipment, both not shown in  FIG. 1 . 
         [0026]    The inner lining  21  of the uterine cavity  20  is a potential space. To visualize features, contours and structures within the uterine cavity  20 , distension media  70  can be supplied from syringe  63  or other fluid supplying source. The inner most part of the inner lining  21  is the endometrial lining  22  in which this tissue and cells are desired for pathological anal sis. Other structures such as polyps, myomas, adhesions, fibroids, septated tissue, and other implantable devices may be located within or protruding into the uterine cavity  20  at the time of examination and their visualization is facilitated by the distension media  70  which separates the potential space (not shown as a potential in these sketches) within the uterine cavity  20 . 
         [0027]      FIGS. 2   a,    2   b,    2   c,  and  2   d  illustrate examples acorn tips  50  or similar devices that can engage the exocervical opening  30  of a patient, shown in cross-section. In  FIG. 2   a,  another acorn tip is depicted as a cylindrical block  52  with outer diameter  53 . In practice, the cylindrical block  52  is made of rigid materials such as stainless steel, plastic, or combination of both and is designed to be pressed against the exocervical opening  30 . The cylindrical block  52  can have a distal end surface  54  that can be flat, convex, or concave. In  FIG. 2   a,  the cylindrical block is shown with distal end surface  54  drawn as a convex surface. 
         [0028]      FIG. 2   b  illustrates a cervical cup  55  which is similar in function to the acorn tip. The cervical cup is designed to engage the exocervical opening with leading edge  57 . The area surrounding, the exocervical opening  30  is engaged by outer rim  56  of the cervical cup  55 . Within the cervical cup  55 , a lumen  58  is connected to a syringe  63  or other vacuum supplying source, not shown. By applying vacuum pressure within the cervical cup  55 , the outer rim  56  is compressed against the area surrounding the exocervical opening  30  to create a seal. 
         [0029]      FIG. 2   c  illustrates a balloon  90  that is placed on the distal end portion  3  of a device  1 . The balloon can be inflated by air, gas, fluid, saline, or contrast agent through connection  91  by a syringe  63  or other fluid or air supplying source, not shown. In theory the balloon can be placed on a separate, concentric catheter body  11  so that the insertion depth of the device  1  can be configured appropriately as per the patient&#39;s anatomy. In practice, due to the pressure from the air or fluid within the balloon  90 , the balloon  90  can back away proximally from the exocervical opening  30  unless stabilizers are employed by a tenaculum, not shown, on the cervix  31 . 
         [0030]      FIG. 2   d  illustrates another variation of balloon  90  which is inflated within the endocervical canal  31  to create a seal. In this configuration, the air or fluid pressure from the balloon  90  on the endocervical canal can create additional pain and discomfort for the patient. In practice, since the endocervical canal can be irregular in shape, inner diameter, or tortuosity, a balloon  90  can be difficult to stabilize within the cervix  31  without modifications to the balloon surface for greater adhesion to the inner lining of the endocervical canal, or the use of tenaculum stabilizer as described above. Finally, placing the balloon  90  within the uterine cavity  20  at the distal end of the endocervical canal  31  is less desirous since the presence of balloon  90  can obscure anatomical features within uterine cavity  20  during the examination. 
         [0031]      FIG. 3   a  illustrates one configuration of a new sealable acorn tip  101  about to engage a cross-sectional view of an exocervical opening  30 , of a patient. The sealable acorn tip  101  has a smaller distal end  102 , in profile, than the proximal end  103  and a length  104 . The sealable acorn tip  101  is made from a deformable, resilient material such as silicone. The silicone material can be made from durometers as low as 5 and as high as 60 with 10 to 20 durometer being optimal. Within the sealable acorn tip  101  as separate back plate  105  is placed. Back plate  105  is made from a rigid plastic or metal, and has a diameter or profile less than proximal end  103 . The sealable acorn tip  101  can be placed on a translatable or slidable outer catheter  110  that is configured to slide on the distal end portion  3  of device  1 . Back plate  105  can be attached to the distal end of outer catheter  110 . Back plate  105  can be embedded within sealable acorn tip  101  with pad area  108 . Sealable acorn tip  101  can be free floating on outer catheter  110  and can stay attached to back plate  105  through a process of insert molding or other mechanical attachment. Back plate  105  can be affixed to outer catheter  110  or its shaft  111 . Thus, areas  113  in  FIG. 3   a  indicate areas without direct adhesion of the sealable acorn tip  101  and outer catheter  110  and shaft  111 . Holes and other mechanical features within the back plate  105  create mechanical fixation for the sealable acorn tip  101 . The sealable acorn tip  101  can be directly adhered to the back plate  105  In addition, outer catheter  110  and shaft  111  can have a re-positionable clip  112  on the proximal end of area  113 . 
         [0032]      FIG. 3   a  also shows sealable acorn tip  101  with leading distal end  102  that is flexible, resilient, and adapted to have a minimal profile for entry into the exocervical opening  30 . Just proximal to the distal end  102 , a curved, funnel-shaped neck  106  transforms from a concave curve  107  into a larger diameter, convex curve  108  just before the back plate  105  located at the proximal portion of the sealable acorn tip  101 . The inflection point  109  can be located at a distance equal to 50%, plus or minus 20%, of the length  104  of the sealable acorn tip  105 . By this terminology, an inflection point  109  at 70% would be closer to the proximal end  103  of the sealable acorn tip  101  and would in turn have a longer neck portion  106  and shorter pad area  108 . The diameter of the proximal end  103  can be a equal to or larger than 100% larger than the diameter of the distal end  102 , or equal to or larger than 200% the diameter of the distal end  102 . 
         [0033]      FIG. 3   b  illustrates the sealable acorn tip  101  in use while forward pressure is being applied by the physician (not. shown). The sealable acorn tip  101  provides a sealing element to the endocervical canal  31  to provide distension in the uterine cavity  20  as a result of the free floating aspect and re-formable shape of the sealable acorn tip  101 , As the physician provides forward pressure on the device, the back plate  105  and re-forms the sealable acorn tip  101  by providing a re-forming surface from within the sealable acorn tip  101 . The distal end  102  intubates the exocervical canal and the bulging, proximal end  103 , which expands in outer diameter in response to the forward pressure, serves to occlude the endocervical canal  31 . Also in response to forward pressure, neck portion  106  expands in outer diameter and depending upon the patient anatomy and the forward pressure applied by the physician, the entire length of the sealable acorn tip can compress up to 50%. In  FIG. 3   b,  distal surface of back plate  105  is illustrated as a flat surface but the distal surface may be convex, conical. or contain multiple projections to provide further re-forming force to the sealable acorn tip  101 . 
         [0034]    The sealable acorn tip  101  can be resilient and translucent, for example, so the physician has visibility of the approaching cervix as the device is being inserted. The sealable acorn tip can have an illumination element or LED (not shown) that can provide additional light within the vagina. Illumination can be provided in a co-axial fashion as an added component to the outer catheter shaft  110 , illumination not shown. 
         [0035]    The sealable acorn tip  101  can be applied to a number of devices and sheaths that are used in uterine cavity assessment without biopsy including diagnostic and operative hysteroscopy, hysterosalpingography, SIS, and intrauterine insemination. 
         [0036]      FIG. 3   a  illustrates that re-positionable clip  112  can be located the proximal end  113  of outer catheter  110 , for example, to provide a pre-determined insertion depth for the device within the uterine cavity  20 . Re-positionable dip  112  can have two configurations. In the normal or resting state, the re-positionable clip  112  can provide a fixation force with holding grips  117  for outer catheter  110  on distal end portion  113  of a device. When outer tabs  116  of the re-positionable clip  112  are compressed, holding grips  117  can be released or open to remove the fixation force. Thus the re-positionable clip  112  can have a resilient force in the closed position to hold the repositionable clip  112  on the device. The re-positionable clip can be configured to close upon the compression force supplied by the physician and open upon a releasing force by the physician. 
         [0037]      FIG. 4  illustrates one configuration of an apparatus for performing simultaneous, concurrent, or concomitant sonography and biopsy. At the proximal end of device  200 , there is a handle  210 , which is shown in partial cross section. The handle  210  can be grasped by the physician with one hand. Within handle  210 , there can be a lever  220  shown in two positions. In Position A, the lever can have a fluid bag  230  that can contain saline, contrast agent, therapeutic agent such as lidocaine, or other solution that enables visualization by ultrasonography or radiography, or combinations thereof. In Postion B indicated in the drawing, the lever  220  can he depressed closer to handle  210  which forces the fluid in bag  230  to be ejected from the device  200  at its distal end  205 . Lever  220  facilitates the delivery of fluid from bag  230  since the physician does not need to move or withdraw his or her hand to force the action to occur. Prior to ejecting the fluid, and near the index finger of the physician, there can be a lever or trigger  240  that can be actuated by the physician prior to ejecting the fluid. Trigger  240  can be a gate valve, stop cock, or pinch valve but can be positioned and actuated without requiring the physician to use another hand, or change hand position, on handle  210 . Actuating the trigger  240  Opens the conduit  250  pass the valve  241  and through conduit  251 . From there fluid flows through T-connector  260  with O-ring seal at its proximal end  261 , The O-ring seal (not shown) allows for a biopsy instrument  300  to translate and rotate through T-connector  260  without a loss of fluid or leak at the proximal end  261 . 
         [0038]    Alternatively, trigger  240  mechanism can be a check valve (not shown) that can remain in the closed condition or state until the physician squeezes the fluid bag  230  with enough force to open the cracking pressure of the check valve. Such cracking pressure can be 1 to 2 psi or greater. 
         [0039]    Handle  210  can contain a mechanism for advancing, rotating, and retracting a biopsy instrument  300  contained within the central lumen of device  200 . Advancement and retraction of the biopsy instrument  300  can be done by pushing button  310  forward or backward on track  311 . The position of button  300  can be placed to allow a one-handed approach to actuating the biopsy instrument  300  without requiring the physician to move or alter his or her hand position throughout the entire procedure. In practice, the biopsy instrument  300  can be advanced forward along track  311  in the translational direction indicated by motion  315 . Once advanced, the biopsy component  301 , shown as biopsy bristles or brushes, can be positioned inside the uterine cavity (not shown) and beyond the distal end  205  of device  200 . Other biopsy components are feasible including ridges, mechanical shavers, or graspers (not shown). Moreover once advanced from the distal end  205  of device  200 , turn knob  312  is provided on handle  210  that can be easily rotated, as indicated by motion  313 . The motion  313  serves to rotate the central core  314  of the biopsy instrument  300  and thereby rotates the biopsy components  301  in the motion  317  indicated, Once rotated inside the uterine cavity (not shown), the biopsy instrument  300  is withdrawn back into the distal end  205  of device  200  by retracting the button  310  back along track  311 . 
         [0040]    Outer catheter  240  can be at the mid-section of device  200 . Outer catheter  240  can contain a reposition clip  248  at its proximal end and a sealable acorn tip  245  at its distal end.  FIG. 4   a  depicts the sealable acorn tip  245  in a state prior to intubation within the exocervix of a patient (not shown).  FIG. 4   b  depicts the sealable acorn tip  245  in a state in which the physician has placed the device  200  under a compressive force against the exocervix (not shown) in which the sealable acorn tip is depicted with bulging proximal end as a result of the back plate pushing the proximal pad and neck as a result of the free floating attachment of the sealable acorn tip  245  that was described earlier. 
         [0041]    As described earlier, re-positionable clip  248  can be placed in a state that locks outer catheter  240  to the device. The location of the re-positionable clip  248  can be placed to allow the physician to lock the location of the sealable acorn tip  245  outside of the vagina. To facilitate the re-positioning performed by the physician, two sets of indicia can be provided. Distal indicia indicated by  271 ,  272 , and  273  in  FIGS. 4   a  and  4   b.  More or less distal indicia that provide a frame of reference for depth of insertion are possible. Distal indicia  271 ,  272 , and  273  indicate the depth of insertion of distal end  205  within the uterine cavity (not shown). Proximal indicia,  276 ,  277 , and  278  can provide a visual reference for the physician while the device  200  is inserted inside the patient. Proximal indicia  276 ,  277 , and  278  can remain outside of the vagina as a result of its location on device  200  and the length of outer catheter  240 . The device can have more or less proximal indicia that can provide an external frame of reference for the physician. 
         [0042]    Biopsy instrument  300  can have a bulbous, rounded, tear-drop shaped, or ball tip  400  at its distal end at the distal end  205  of device  200 . The ball tip  400  can provide a less traumatic leading surface of device  200 , when the biopsy instrument  300  is retracted within the distal end  205  of the device  200 , and for the biopsy instrument  300  when the biopsy instrument  300  is advanced beyond the distal end  205  when a biopsy is taken. The proximal hemi-spherical section of ball tip  300  can have fenestrations, grooves, or channels so that fluid from bag  230  can be easily ejected from distal end  205  when the ball tip  400  is full retracted within distal end  205 . 
         [0043]      FIG. 4   a  illustrates a handle  210  that can eject fluid from bag  230  by the actuation of a lever  220  by pumping action that takes lever  220  from Position A to Position B in a one handed technique. There are several alternatives for this action including the introduction of air or gas pressure with a CO 2  cartridge or pumping air pressure within the bag system through a separate check valve (not shown). In addition, the fluid bag could be positioned in a foot pedal system in which the physician can eject fluid by depressing a foot actuated system (not shown). Other pump systems or gravity feed systems are possible. 
         [0044]    In  FIGS. 4   a  and  4   b,  fluid bag  230  can be supplied prefilled to the physician. In addition, at the proximal end of handle  210 , or anywhere on handle  210 , a luer connector  600  is placed with conduit  610  connected to fluid bag  230 . With luer connector  600  and conduit  610 , the physician can add different or additional fluid media or agents to fluid bag  230 , for example when media is desired for further diagnostic information, or if a new fluid agent, such as a gel or foam, was desired for added visualization or the application of a therapeutic agent, such as lidocaine, is desired during a procedure. 
         [0045]    In addition, the advancement or button  310  and subsequent rotation of turn knob  312  can be controlled by a motor (not shown). The addition of the motor would continue the desire to keep a one-handed procedure without additional manipulations for the physician. There would be cost benefits by not having a motor as depicted in  FIGS. 4   a  and  4   b.    
         [0046]      FIGS. 5   a  and  5   b  illustrate one configuration of an apparatus for performing simultaneous sonography and biopsy that engages a vaginal ultrasound probe  810  during a uterine cavity assessment (uterine cavity not shown). During a procedure, gynecologists will typically use a vaginal ultrasound probe for performing a diagnostic assessment. In practice, this requires one hand of the physician to be on the vaginal ultrasound probe  810  while the other hand would be needed to remain on the handle  805  of device  800 . One mechanism to make this process easier for the physician is illustrated in  FIG. 5   a  with handle  805  in side view, and  FIG. 5   b  with handle  805  in top view. In both  FIGS. 5   a  and  5   b,  rotatable, repositionable, clip  815  is located on the distal portion of handle  805 . Clip  815  contains arm projections  820  that are configured to grasp and lock onto vaginal ultrasound probe  810 . Arm projections  820  can contain indentations, grips, mechanical locks, magnets. Velcro, or straps to maintain position of the vaginal ultrasound probe  810  with handle  805 . 
         [0047]    An apparatus and method for performing simultaneous ultrasonography, or radiographic visualization, and biopsy without loss of visualization during the biopsy step is disclosed herein. The apparatus is configured to perform both procedures with one instrument and one hand position by the physician. The one hand position can allow the physician to use his or her free hand to stabilize the patient, operate ultrasound controls, or manipulate another device or instrument without the requirement of additional manpower. Being able to perform both procedures with only one device insertion can reduce procedure time and cost for the physician, patient, and payors. 
         [0048]    The sealable acorn tip and outer catheter configuration with re-positionable clip can be a separate device for mounting onto traditional hysteroscopy sheaths and other devices utilized in uterine cavity procedures. 
         [0049]    The system described herein could be utilized as a platform for the introduction of other materials and therapeutic agents into the uterine cavity such as gels, foams, and contrast agents for either echogenicity or radiographic visualization. Other therapeutic agents can be applied through this platform including sclerosing, contraception, and adhesion prevention agents. Additional agents can include gametes, blastocysts, and other biological products utilized in infertility procedures. 
         [0050]    The biopsy instrument described herein could be replaced or removed before or after use by another instrument such as a polypectomy snare (with or without a coupling to an electrosurgical energy source), biopy cup, grasper, probe, endoscope, drug or energy delivery device, or other instrument for a therapeutic or diagnostic procedure. The biopsy instrument can  1  I be replaced by an implant delivery device that provides permanent contraception within the fallopian tube or uterine cavity. 
         [0051]    The physician can locate the biopsy instrument at a targeted region within the body cavity, for example by using ultrasonography or radiographic visualization simultaneously with a biopsy procedure. For gynecologic practice, physicians may want to target certain regions of the uterus if atypical lesions or identified with diagnostic visualization. Utilizing a biopsy instrument that does not require vacuum pressure to withdraw tissue within the distal end of the device allows for both of these procedures to be performed simultaneously. Coupled with the use of a sealable acorn tip that reforms within the endocervical canal at the exocervix this procedure can reduce the amount of manpower, steps, or hands required to perform the procedure. This is especially true since endocervical canals are presented to the physician in a multitude of shapes and configurations. They are not round and cylindrical but instead in majority they are elliptical, irregular, and unpredictable in shape and configuration. 
         [0052]    In describing the method of performing simultaneous ultrasonography, or radiographic examination, and biopsy, the physician would prepare the vagina and cervix as per standard technique. Typically the physician would take a scout Film or ultrasound view to distinguish anatomical landmarks. In some cases, the length of the cervical canal and uterine cavity would be determined. Alternatively, the physician may sound or measure the length of the uterine cavity by retracting the sealable acorn tip to its most proximal position prior to insertion through the cervix and into the uterine cavity. If the length of the cervix and uterine cavity is determined, and a depth of insertion into the uterine cavity is calculated, the physician could then set the re-positionable clip on the device to the desired length using the indicia provided on the device. The device could be inserted into the cervix until the sealable acorn tip engages the exocervix with slight forward pressure. The bulging of the proximal pad area of the sealable acorn tip can be visualized and felt with tactile sensation. The trigger on the handle of the device can then be released to open the conduit of the fluid bag to the distal end of the device. 
         [0053]    Alternatively, the physician may eject fluid out of the distal end of the device while inserting the device through the cervix to create a hydraulic distending action through the endocervical canal and uterine cavity. Once positioned in the uterine cavity with the sealable acorn tip engaged and reformed into place at the exocervix, the physician can then pump additional fluid, such as saline, into the uterine cavity to distend the cavity and create room for visualization. Additional fluid may be placed into the cavity for assessing patency in the fallopian tubes and viewing other anatomical features. Additional fluid can be inserted into the proximal luer connector and conduit that facilitates the addition of extra fluid during a procedure. The fluid bag can be pre-filled with an appropriate amount of fluid at the start of a procedure. The physician can change the depth of insertion of the device by opening and repositioning the clip if necessary by utilizing the proximal indicia, which is visible outside of the vagina, to re-position the distal end of the device. The physician may wish to target the distal end of the device at or near a region of interest inside the uterine cavity. The physician can advance the button on the handle to advance the biopsy instrument towards the region of interest. The rotatable turn knob allows the physician to rotate and manipulate the biopsy components in a fashion to collect, cut, grasp, or shave the tissue of interest. Once done, the physician can retract the button on the handle to retract the biopsy instrument within the distal end of the device. Then the physician can withdraw the entire device from the patient. Once outside of the patient, the physician can place the distal of the device into a specimen container and re-advance the biopsy instrument within the specimen container. The physician may elect to advance and retract the biopsy instrument several times against, the distal end of the device to further release tissue contents collected on the biopsy components. 
         [0054]    Materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the disclosure in terms of additional acts commonly or logically employed. Any optional feature of the variations described herein may be set forth and claimed independently, or in combination with any one or more of the features described herein. Reference to a singular item includes the possibility that there are plural of the same items present. More specifically, as used herein, the singular forms “a” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The breadth of the present disclosure is not to he limited by the subject specification, but rather only by the plain meaning of the terms employed. 
         [0055]    All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.