US20140128732A1 - Biopsy and sonography method and apparatus for assessing bodily cavities - Google Patents

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, 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 APPLICATION
• This application claims the benefit of U.S. Provisional Application No. 61/723,114, filed 6 Nov. 2012, which is incorporated by reference herein in its entirety.
FIELD OF THE DISCLOSURE
• 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
• 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'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.
• 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'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.
• 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.
• 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'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 luer 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.
• 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.
• 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 come 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.
• 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.
• 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.
• 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 of radiographic techniques. Thereby the location of the biopsy sample is not known.
• 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 be 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.
• In U.S. Pat. No. 8,157,745 to Schoot, which is incorporated by 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.
• 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 a targeted collection of tissue.
SUMMARY OF THE INVENTION
• 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.
• 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.
• 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 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.
• 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 judicial, 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
• FIG. 1 illustrates one example of a device, not the invention, within the cross-section of a uterine cavity.
• FIGS. 2a,2b,2c, and2dillustrate examples of acorn tips, not the invention, engaging a cross-section view of an exocervix of a patient.
• FIGS. 3aand3billustrate one configuration of a new sealable acorn tip in a cross-sectional view of a uterine cavity of a patient.
• FIGS. 4aand4billustrate one configuration of a device for performing simultaneous sonography and biopsy with partial cross sectional views.
• FIGS. 5aand5billustrate one configuration of an apparatus for performing simultaneous sonography and biopsy that engages a vaginal ultrasound probe during a uterine cavity assessment.
DETAILED DESCRIPTION
• InFIG. 1 illustrates a device1 within a cross-sectional view of theuterine cavity20. The distal end of the device3 is shown with a distal end opening4, inner lumen6, and indicia5 for determining the depth of insertion within the uterine cavity using theexocervix30 of the cervix or endocervical canal31 as a frame of reference. Located at theexocervical opening30, anacorn tip50 is placed and pressed into theexocervical opening30 to provide a seal for media within theuterine cavity20. A connector or coupling60 can be located on the proximal end of the device1. This coupling60 can be configured as a stopcock, T-connector or Y-connector to allow for the injection of fluids or media into connector opening61. This connector opening61 can be configured as a luer connector to allow for the connection of asyringe63 or other fluid supplying source. In operation thesyringe63 or other fluid supplying source64 can be used to distend theuterine cavity20 when performing an ultrasonographic or radiographic examination of the uterine cavity. Ultrasonography and radiographic equipment are not shown. From connector opening61, asyringe63 or other vacuum supplying source can be can be connected to supply negative pressure within the inner lumen6 of device1 to withdraw fluid and tissue from the uterine cavity within the distal end opening4.
• Theacorn tip50 can be positioned at theexocervical opening30. Theacorn tip50 can be configured in a conical shape with smaller diameter distal end51 and larger diameter proximal end52. Theacorn tip50 can be slid or re-positioned on distal end of the device3 to correspond to the desired depth of insertion as indicated by the indicia5. In practice, a physician may perform a scout film of theuterine cavity20 by use of the ultrasonographic or radiographic equipment, both not shown inFIG. 1.
• The inner lining21 of theuterine cavity20 is a potential space. To visualize features, contours and structures within theuterine cavity20, distension media70 can be supplied fromsyringe63 or other fluid supplying source. The inner most part of the inner lining21 is the endometrial lining22 in which this tissue and cells are desired for pathological analysis. Other structures such as polyps, myomas, adhesions, fibroids, septated tissue, and other implantable devices may be located within of protruding into theuterine cavity20 at the time of examination and their visualization is facilitated by the distension media70 which separates the potential space (not shown as a potential in these sketches) within theuterine cavity20.
• FIGS. 2a,2b,2c, and2dillustrateexamples acorn tips50 or similar devices that can engage the exocervical opening30 of a patient, shown in cross-section. InFIG. 2a, another acorn tip is depicted as a cylindrical block52 with outer diameter53. In practice, the cylindrical block52 is made of rigid materials such as stainless steel, plastic, or combination of both and is designed to be pressed against theexocervical opening30. The cylindrical block52 can have a distal end surface54 that can be flat, convex, or concave. InFIG. 2a, the cylindrical block is shown with distal end surface54 drawn as a convex surface.
• FIG. 2billustrates a cervical cup55 which is similar in function to the acorn tip. The cervical cup is designed to engage the exocervical opening with leading edge57. The area surrounding theexocervical opening30 is engaged by outer rim56 of the cervical cup55. Within the cervical cup55, a lumen58 is connected to asyringe63 or other vacuum supplying source, not shown. By applying vacuum pressure within the cervical clip55, the outer rim56 is compressed against the area surrounding theexocervical opening30 to create a seal.
• FIG. 2C illustrates a balloon90 that is placed on the distal end portion3 of a device1. The balloon can be inflated by air, gas, fluid, saline, or contrast agent through connection91 by asyringe63 or other fluid or air supplying source, not shown. In theory the balloon can be placed on a separate,concentric catheter body11 so that the insertion depth of the device1 can be configured appropriately as per the patient's anatomy. In practice, due to the pressure from the air or fluid within the balloon90, the balloon90 can back away proximally from theexocervical opening30 unless stabilizers are employed by a tenaculum, not shown, on the cervix31.
• FIG. 2dillustrates another variation of balloon90 which is inflated within the endocervical canal31 to create a seal. In this configuration, the air or fluid pressure from the balloon90 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 balloon90 can be difficult to stabilize within the cervix31 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 balloon90 within theuterine cavity20 at the distal end of the endocervical canal31 is less desirous since the presence of balloon90 can obscure anatomical features withinuterine cavity20 during the examination.
• FIG. 3aillustrates one configuration of a new sealable acorn tip101 about to engage a cross-sectional view of anexocervical opening30, of a patient. The sealable acorn tip101 has a smaller distal end102, in profile, than the proximal end103 and alength104. The sealable acorn tip101 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 tip101 a separate back plate105 is placed. Back plate105 is made from a rigid plastic or metal, and has a diameter or profile less than proximal end103. The sealable acorn tip101 can be placed on a translatable or slidable outer catheter110 that is configured to slide on the distal end portion3 of device1. Back plate105 can be attached to the distal end of outer catheter110. Back plate105 can be embedded within sealable acorn tip101 withpad area108. Sealable acorn tip101 can be free floating on outer catheter110 and can stay attached to back plate105 through a process of insert molding or other mechanical attachment. Back plate105 can be affixed to outer catheter110 or its shaft111. Thus,areas113 inFIG. 3aindicate areas without direct adhesion of the sealable acorn tip101 and outer catheter110 and shaft111. Holes and other mechanical features within the back plate105 create mechanical fixation for the sealable acorn tip101. The sealable acorn tip101 can be directly adhered to the back plate105. In addition, outer catheter110 and shaft111 can have are-positionable clip112 on the proximal end ofarea113.
• FIG. 3aalso shows sealable acorn tip101 with leading distal end102 that is flexible, resilient, and adapted to have a minimal profile for entry into theexocervical opening30. Just proximal to the distal end102, a curved, funnel-shaped neck106 transforms from a concave curve107 into a larger diameter,convex curve108 just before the back plate105 located at the proximal portion of the sealable acorn tip101. The inflection point109 can be located at a distance equal to 50%, plus or minus 20%, of thelength104 of the sealable acorn tip105. By this terminology, an inflection point109 at 70% would be closer to the proximal end103 of the sealable acorn tip101 and would in turn have a longer neck portion106 andshorter pad area108. The diameter of the proximal end103 can be a equal to or larger than 100% larger than the diameter of the distal end102, or equal to or larger than 200% the diameter of the distal end102.
• FIG. 3billustrates the sealable acorn tip101 in use while forward pressure is being applied by the physician (not shown). The sealable acorn tip101 provides a sealing element to the endocervical canal31 to provide distension in theuterine cavity20 as a result of the free floating aspect and re-formable shape of the sealable acorn tip101. As the physician provides forward pressure on the device, the back plate105 and re-forms the sealable acorn tip101 by providing a re-forming surface from within the sealable acorn tip101. The distal end102 intubates the exocervical canal and the bulging proximal end103, which expands in outer diameter in response to the forward pressure, serves to occlude the endocervical canal31. Also in response to forward pressure, neck portion106 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%. InFIG. 3b, distal surface of back plate105 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 tip101.
• The sealable acorn tip101 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 shaft110, illumination not shown.
• The sealable acorn tip101 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.
• FIG. 3aillustrates thatre-positionable clip112 can be located theproximal end113 of outer catheter110, for example, to provide a pre-determined insertion depth for the device within theuterine cavity20.Re-positionable clip112 can have two configurations. In the normal or resting state, there-positionable clip112 can provide a fixation force with holding grips117 for outer catheter110 ondistal end portion113 of a device. When outer tabs116 of there-positionable clip112 are compressed, holding grips117 can be released or open to remove the fixation force. Thus there-positionable clip112 can have a resilient force in the closed position to hold therepositionable clip112 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.
• FIG. 4 illustrates one configuration of an apparatus for performing simultaneous, concurrent, or concomitant sonography and biopsy. At the proximal end ofdevice200, there is ahandle210, which is shown in partial cross section. Thehandle210 can be grasped by the physician with one hand. Withinhandle210, there can be alever220 shown in two positions. In Position A, the lever can have a fluid bag230 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 Position B indicated in the drawing, thelever220 can be depressed closer to handle210 which forces the fluid in bag230 to be ejected from thedevice200 at itsdistal end205.Lever220 facilitates the delivery of fluid from bag230 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 trigger240 that can be actuated by the physician prior to ejecting the fluid.Trigger240 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, onhandle210. Actuating thetrigger240 opens the conduit250 pass the valve241 and through conduit251. From there fluid flows through T-connector260 with o-ring seal at itsproximal end261. The o-ring seal (not shown) allows for a biopsy instrument300 to translate and rotate through T-connector260 without a loss of fluid or leak at theproximal end261.
• Alternatively, trigger240 mechanism can be a check valve (not shown) that can remain in the closed condition or state until the physician squeezes the fluid bag230 with enough force to open the cracking pressure of the check valve. Such cracking pressure can be 1 to 2 psi or greater.
• Handle210 can contain a mechanism for advancing, rotating, and retracting a biopsy installment300 contained within the central lumen ofdevice200. Advancement and retraction of the biopsy instrument300 can be done by pushing button310 forward or backward on track311. The position of button300 can be placed to allow a one-handed approach to actuating the biopsy instrument300 without requiring the physician to move or alter his or her hand position throughout the entire procedure. In practice, the biopsy instrument300 can be advanced forward along track311 in the translational direction indicated by motion315. Once advanced, thebiopsy component301, shown as biopsy bristles or brushes, can be positioned inside the uterine cavity (not shown) and beyond thedistal end205 ofdevice200. Other biopsy components are feasible including ridges, mechanical shavers, or graspers (not shown). Moreover once advanced from thedistal end205 ofdevice200,turn knob312 is provided onhandle210 that can be easily rotated, as indicated bymotion313. Themotion313 serves to rotate thecentral core314 of the biopsy instrument300 and thereby rotates thebiopsy components301 in the motion317 indicated. Once rotated inside the uterine cavity (not shown), the biopsy instrument300 is withdrawn back into thedistal end205 ofdevice200 by retracting the button310 back along track311.
• Outer catheter240 can be at the mid-section ofdevice200.Outer catheter240 can contain a repositionclip248 at its proximal end and a sealable acorn tip245 at its distal end.FIG. 4adepicts the sealable acorn tip245 in a state prior to intubation within the exocervix of a patient (not shown).FIG. 4bdepicts the sealable acorn tip245 in a state in which the physician has placed thedevice200 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 flee floating attachment of the sealable acorn tip245 that was described earlier.
• As described earlier,re-positionable clip248 can be placed in a state that locksouter catheter240 to the device. The location of there-positionable clip248 can be placed to allow the physician to lock the location of the sealable acorn tip245 outside of the vagina. To facilitate the re-positioning performed by the physician, two sets of indicia can be provided. Distal indicia indicated by271,272, and273 inFIGS. 4aand4b. More or less distal indicia that provide a frame of reference for depth of insertion are possible. Distal indicia271,272, and273 indicate the depth of insertion ofdistal end205 within the uterine cavity (not shown). Proximal indicia,276,277, and278 can provide a visual reference for the physician while thedevice200 is inserted inside the patient.Proximal indicia276,277, and278 can remain outside of the vagina as a result of its location ondevice200 and the length ofouter catheter240. The device can have more or less proximal indicia that can provide an external frame of reference for the physician.
• Biopsy instillment300 can have a bulbous, rounded, tear-drop shaped, orball tip400 at its distal end at thedistal end205 ofdevice200. Theball tip400 can provide a less traumatic leading surface ofdevice200, when the biopsy instrument300 is retracted within thedistal end205 of thedevice200, and for the biopsy instrument300 when the biopsy instrument300 is advanced beyond thedistal end205 when a biopsy is taken. The proximal hemi-spherical section of ball tip300 can have fenestrations, grooves, or channels so that fluid from bag230 can be easily ejected fromdistal end205 when theball tip400 is full retracted withindistal end205.
• FIG. 4aillustrates ahandle210 that can eject fluid from bag230 by the actuation of alever220 by pumping action that takeslever220 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 CO2 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.
• InFIGS. 4aand4b, fluid bag230 can be supplied prefilled to the physician. In addition, at the proximal end ofhandle210, or anywhere onhandle210, a luer connector600 is placed with conduit610 connected to fluid bag230. With luer connector600 and conduit610, the physician can add different or additional fluid media or agents to fluid bag230, 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.
• In addition, the advancement or button310 and subsequent rotation ofturn knob312 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 inFIGS. 4aand4b.
• FIGS. 5aand5billustrate one configuration of an apparatus for performing simultaneous sonography and biopsy that engages a vaginal ultrasound probe810 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 probe810 while the other hand would be needed to remain on thehandle805 of device800. One mechanism to make this process easier for the physician is illustrated inFIG. 5awithhandle805 in side view, andFIG. 5bwithhandle805 in top view. In bothFIGS. 5aand5b,rotatable, repositionable, clip815 is located on the distal portion ofhandle805. Clip815 contains arm projections820 that are configured to grasp and lock onto vaginal ultrasound probe810. Arm projections820 can contain indentations, grips, mechanical locks, magnets, Velcro, or straps to maintain position of the vaginal ultrasound probe810 withhandle805.
• 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.
• 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.
• 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.
• The biopsy instillment 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), biopsy cup, grasper, probe, endoscope, drug or energy delivery device, or other instrument for a therapeutic or diagnostic procedure. The biopsy instrument can be replaced by an implant delivery device that provides permanent contraception within the fallopian tube or uterine cavity.
• 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.
• 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.
• 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. On 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.
• 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 be limited by the subject specification, but rather only by the plain meaning of the terms employed.
• 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.

Claims (25)

We claim:

1. A method of performing a procedure on a uterine cavity of a patient, comprising:

visualizing the uterine cavity;

biopsying a tissue comprising at least one of advancing, rotating, and withdrawing a biopsy device into the uterine cavity, wherein the biopsy device comprises a sealable tip on a repositionable component, proximal indicia and distal indicia; and

ejecting fluid from the biopsying, device into the uterine cavity, wherein the biopsying device is configured to biopsy and eject fluid under the control of a single hand of a user of the device.

2. The method ofclaim 1, wherein the visualizing is concurrent with the biopsying.

3. The method ofclaim 1, wherein the visualizing is concurrent with the ejecting of the fluid.

4. The method ofclaim 1, wherein the visualizing comprises diagnostically visualizing.

5. The method ofclaim 1, further comprising removing the biopsy device from the uterine cavity and then inserting a medical device into the uterine cavity.

6. The method ofclaim 1, wherein ejecting the fluid comprises ejecting a gel into the uterine cavity.

7. The method ofclaim 1, wherein ejecting the fluid comprises ejecting a foam into the uterine cavity.

8. The method ofclaim 1, wherein ejecting the fluid comprises ejecting a contrast agent into the uterine cavity.

9. The method ofclaim 1, wherein ejecting the fluid comprises ejecting a or therapeutic agent into the uterine cavity.

10. The method ofclaim 1, wherein the tip comprises a rigid plate.

11. The method ofclaim 10, wherein the rigid plate is embedded in the tip.

12. The method ofclaim 1, wherein the tip is acorn-shaped.

13. An apparatus for performing a procedure on a uterine cavity of a patient comprising:

a sealable acorn tip;

a handle comprising a pumping lever and a biopsy instrument, wherein the biopsy instrument is configured to translate and rotate with respect to the handle;

a repositioning clip;

a distal indicia;

a proximal indicia; and

a fluid reservoir.

14. The apparatus ofclaim 13, wherein the tip is acorn-shaped.

15. The apparatus ofclaim 13, wherein the tip comprises a rigid plate.

16. The apparatus ofclaim 13, wherein the rigid plate is embedded in the tip.

17. The apparatus ofclaim 13, wherein the fluid reservoir comprises a refillable fluid bag.

18. The apparatus ofclaim 13, wherein the biopsy instrument is configured to advance

19. The apparatus ofclaim 13, wherein the biopsy instrument is configured to withdraw

20. An apparatus for performing a procedure on a uterine cavity of a patient comprising:

an elongated member;

a sealable tip;

a handle;

a repositioning clip;

a distal judicial;

a proximal indicia;

a fluid reservoir; and

a vaginal ultrasound probe comprising a rotatable clip attached to at least one of the elongated member and the handle.

21. The apparatus ofclaim 20, wherein the tip is acorn-shaped.

22. The apparatus ofclaim 20, wherein the tip comprises a rigid plate.

23. The apparatus ofclaim 20, wherein the rigid plate is embedded in the tip.

24. The apparatus ofclaim 20, wherein the fluid reservoir comprises a refillable fluid bag.

25. The apparatus ofclaim 20, wherein the rotatable clip is configured to be translatable along at least one of the elongated member and the handle.

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