Medical devices for women's reproductive health and their uses

Abstract

A single handheld medical device for performing endometrial curettage and / or HSG procedures is disclosed. A preferred embodiment includes a body including a handle integrally connected to an arm with an articulating member at its distal end. The handle includes a means for storing and pumping fluid into the uterus and for locating the articulating member within the uterus using ultrasound or x-rays. The arm further includes a shield device operable to slidably engage with the arm of the device, the shield and arm configured to cover and sealingly engage the external cervical os of the cervix to prevent reflux during use. Optional display means are disclosed, including an image screen mountably attached to the device and in communication with a scope disposed within the arm.

Description

[Technical Field]

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63,074,096, filed September 3, 2020, U.S. Provisional Application No. 63,110,544, filed November 6, 2020, U.S. Provisional Application No. 63,123,694, filed December 10, 2020, and U.S. Provisional Application No. 63,136,338, filed January 12, 2021, the entire contents of which are incorporated herein by reference as if fully set forth herein.

[0002] (Technical field) The present invention relates generally to medical devices used in female reproductive procedures. More specifically, the present invention relates to devices and methods for improving the intrauterine environment before and during conception. [Background technology]

[0003] Assisted reproductive technologies ("ART") are not a new concept. Numerous issues exist that can hinder or reduce the chances of a successful pregnancy. While ART has made certain technological advancements to solve recurring problems with women's fertility, little has been done to increase the chances of a fertilized egg successfully implanting in the uterine lining - a critical step in the conception process.

[0004] Once an egg is fertilized, it must successfully implant itself into the uterine wall for placentation to occur, allowing the fertilized egg to receive necessary nutrients from the mother. Unfortunately, even if fertilization is successful, recurrent implantation failure ("RIF") often occurs in mothers using ART. This implantation failure is often due to abnormalities in the uterine lining or abnormalities in the mother's immune system at the time of implantation.

[0005] Currently, doctors intentionally scratch the endometrial layer to create an inflammatory response in the uterine cavity before ovulation. The body's natural wound-healing response after scratching improves the endometrial environment, making it more favorable for embryo implantation and pregnancy.

[0006] Currently, there are no devices calibrated to allow a physician to create precise "scratches" along the endometrial layer while viewing the device's position inside the patient's body. Currently, a medical professional takes a catheter or other similar device and, without being able to see it, pushes it forward until they feel some resistance. They then begin scratching, believing that the resistance is coming from the uterine wall. This seemingly archaic and barbaric procedure can result in unnecessarily deep punctures or even complete perforation of the uterine wall.

[0007] A patient's chances of a successful pregnancy are higher if their fallopian tubes are unblocked. A hysterosalpingogram (HSG) is an x-ray test performed on a female patient to determine if their fallopian tubes are open (open) and if the inside of their uterus is normal. An HSG is an outpatient procedure that usually takes less than five minutes. It is usually performed after the end of menstruation, before ovulation.

[0008] In a typical HSG procedure, the woman is positioned under a fluoroscope (an X-ray imaging device that takes pictures during the examination) on a table. A gynecologist or radiologist then examines the patient's uterus and places a speculum in her vagina. The cervix is ​​irrigated, and a device (cannula) is inserted into the cervical opening. The physician slowly fills the uterus with an iodine-containing fluid (fluid visible on X-rays) through the cannula. The contrast appears white on the image and can outline the uterus as the fluid moves from the cannula into the uterus and through the fallopian tubes. As the contrast enters the fallopian tubes, it outlines their length and spills out the ends of the tubes if they are open. Abnormalities within the uterine cavity can also be detected by the physician observing the X-ray images when the abnormality disrupts the movement of fluid. A lateral view of the uterus and fallopian tubes is often obtained by having the woman change positions on the table. The procedure typically requires the doctor to use multiple tools simultaneously, including positioning the catheter, syringe, and device to prevent dye leakage, while viewing an X-ray image of the fallopian tubes.

[0009] Typically, the HSG procedure is performed separately from the abrasion procedure to scrape (or scrape) the endometrial layer. This requires the patient to undergo two procedures and the physician to use multiple tools. These existing procedures also require multiple hands working simultaneously to control the various instruments involved. Therefore, there is a strong need for a single device that can be manually controlled with one hand and precisely navigated into the uterus while avoiding unnecessary trauma and injury, while simultaneously releasing the blockage in the patient's fallopian tubes. Summary of the Invention

[0010] The present invention solves existing problems in the art by allowing a physician to carefully guide a device through the cervical canal and into the uterine cavity. Additionally, once inside the uterus, the articulating arms of the device allow the medical professional to precisely make small abrasions in the endometrial wall while avoiding the risk of puncturing or penetrating the uterine wall.

[0011] The disclosed medical device allows a user to perform curettage and / or HSG procedures while controlling the instrument with one hand. A preferred embodiment includes a body including a handle integrally connected to an arm that houses an articulation tube. The handle includes a fluid cassette in communication with the articulation tube and a trigger. When the trigger is actuated, the articulation tube is operable to curl over the distal end of the arm. The handle further includes means for pumping fluid from the cassette through the articulation tube. The arm further includes a shield device (or obstructing device) operable to slidably engage with the arm of the device, the shield and arm configured to cover and sealingly engage the external cervical os of the cervix to prevent reflux during use.

[0012] Another embodiment of the medical device includes a digital display means that includes the use of a flexible scope located within the arm of the medical device and a display screen mountably attached to the body of the device.

[0013] Alternative embodiments of the medical device include other means for performing curettage, including a retractable balloon, an ensnare tip, or a wire.

[0014] Another embodiment of the present invention includes a method of using the disclosed medical device to perform precise endometrial curettage and / or HSG procedures. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is an isometric view of a medical device according to a preferred embodiment of the present invention, showing the articulation tube in a retracted position. [Figure 2] FIG. 2 is an isometric view of a medical device according to a preferred embodiment of the present invention, showing the articulation tube in an extended position. [Figure 3] FIG. 3 is another isometric view of a medical device according to a preferred embodiment of the present invention, showing the articulation tube in an extended position. [Figure 4] FIG. 4 is a side view of a medical device according to a preferred embodiment of the present invention, showing the articulation tube in an extended position. [Figure 5] FIG. 5 is a top view of a medical device according to a preferred embodiment of the present invention, showing the articulation tube in an extended position. [Figure 6] FIG. 6 is a cutaway cross-sectional view of a medical device according to a preferred embodiment of the present invention, showing lumens located within the arms. [Figure 7] FIG. 7 is an exploded view of a medical device according to a preferred embodiment of the present invention. [Figure 8] FIG. 8 is a side view of another embodiment of the present invention. [Figure 9] FIG. 9 is a side view of another embodiment of the present invention showing the wire tip. [Figure 10] FIG. 10 is a perspective view of another embodiment of the present invention showing the wire tip in a retracted position. [Figure 11] FIG. 11 is a perspective view of another embodiment of the present invention showing the wire tip in an extended position. [Figure 12] FIG. 12 is a side view of another embodiment of the present invention showing the inflatable balloon tip in an expanded position. [Figure 13] FIG. 13 is a perspective view of another embodiment of the present invention showing an inflatable balloon tip in an expanded position. [Figure 14] FIG. 14 is a side view of another embodiment of the present invention showing an ensnare tip. [Figure 15] FIG. 15 is a cross-sectional view of a shield device according to an embodiment of the present invention. [Figure 16] FIG. 16 is a top view of a shield device according to an embodiment of the present invention. [Figure 17] FIG. 17 is a bottom view of a shield device according to an embodiment of the present invention. [Figure 18] FIG. 18 is a cross-sectional view of a medical device having an imaging device according to an embodiment of the present invention. [Figure 19] FIG. 19 is a side view of a medical device according to an embodiment of the invention that encloses a syringe and has an articulating tip. DETAILED DESCRIPTION OF THE INVENTION

[0016] 1-7, there is shown a preferred embodiment of a medical device 5. As shown in FIGS. 1-2, the medical device 5 includes a unitary body 10 including a handle 35 attached to an arm 15 by an arched hinge connection 45.

[0017] The arm 15 has a proximal end 20 and a distal end 25, with a joint lumen 30 disposed therein and extending along the length of the arm 15 from the proximal end 20 to the distal end 25. The joint lumen 30 is operable to receive an articulation tube 50 having an open first end and an opposing open second end 52 ( FIG. 6 ) and including an internal bore extending the entire length of the arm 15. The arm 15 and articulation tube 50 should be formed from a material having sufficient flexibility to allow a physician or user to guide the arm through the vagina and cervix and into the uterus.

[0018] The handle 35 includes a trigger 40 and a cartridge port 60 configured to receive a fluid cassette 61. As shown in FIG. 4 , a first end of the articulating tube 50 is preferably in fluid communication with the fluid cassette 61 via a connecting tube 64 equipped with quick-connect fasteners 65. The handle 35 further includes a hinged handle 62 operable to secure the fluid cassette 61 in place. The hinged handle 62 may form an integral part of the handle 35 or may be removably attached to the handle 35. Alternatively, as in the preferred embodiment, the hinged handle 62 may be U-shaped and include an ergonomic plunger 66 configured to be easily actuated by a user's hand while holding the handle 35. When the user squeezes the plunger 66, an inward force is directed against the bladder 63 disposed on the fluid cassette 61, causing fluid to be squeezed from the fluid cassette 61, through the connecting tube 64, and into the first end of the articulation tube 50. The fluid is dispersed from the second end 52 (FIG. 6) of the opening.

[0019] The proximal end 20 of the arm 15 is fixedly attached to the trigger 40 of the handle 25 so that when the trigger 40 is pulled proximally toward the handle 25, the articulation tube 50 extends beyond the distal end 25 of the arm 15. The second end 51 of the articulation tube 50 is operable to curl up to 90° from the longitudinal axis of the articulation tube in the extended position ( FIG. 2 ) and is flexible enough to retract into the articulation lumen 30 in the retracted position ( FIG. 1 ). For example, the articulation tube 50 may be fabricated from a material with shape memory properties, including, for example, nickel titanium (or “NiTi”). The arched hinge connection 45 is formed from a semi-rigid, flexible material (e.g., TR-90 nylon) that can bend when the trigger 40 is pulled while retaining its shape. In embodiments, the trigger and handle are not integrated, but any hinge connection can be used as long as the entire articulation tube 50 is movable axially relative to the arm 15.

[0020] In yet another embodiment of the present invention, the medical device 5 includes a rotator 55 operable to rotate the articulation tube 50 along its longitudinal axis so that the second end 52 of the articulation tube 50 can articulate when in an extended, curled position. As shown in FIGS. 1-2 , the rotator 55 is preferably located proximate the handle 35 so that a user can actuate the rotator 55 with their thumb or fingers while maintaining control of the device 5 with their hand.

[0021] In yet another embodiment of the present invention, the medical device 5 includes a rotational lock 56. The rotational lock 56, when activated, serves to lock the articulation tube 50 in a particular extension position while still allowing the articulation tube 50 to rotate freely. The rotational lock 56 allows the user to release (or disengage) the trigger 40, allowing the user to focus on the procedure without having to apply a constant force to the trigger 40.

[0022] When performing an endometrial scraping, it is important to know the position of the second end 52 of the articulating tube 50 relative to the endometrium. One way to accomplish this is to disperse a fluid or dye into the uterus so that the uterus can be seen by ultrasound or x-ray. In either method, the ultrasound dye or fluoroscopy dye can be a fluid contained in the fluid cassette 61.

[0023] Another embodiment of the medical device 5 includes additional imaging means that allow the user to determine the location of the articular tube 50 within the uterus. As shown in FIG. 6, the arm 15 may include an additional optical lumen 71. As shown in FIG. 7, the optical lumen 71 is adapted to receive a flexible scope 75 (e.g., an optical scope, fiber optic scope, or hysteroscope) with a camera disposed at the distal end 25 of the arm 15. The arm 15 includes a port 72 and an adapter 74 operable to receive and accommodate the scope 75. To enhance viewing capabilities while holding the device 5, an image screen 76 is mountably attached to the body 10. The image screen 76 is in communication with the scope 75 such that images displayed through the scope 75 are enhanced on the image screen 76.

[0024] When the uterus is dilated and viewed with an x-ray or ultrasound, or alternatively, while an HSG procedure is being performed, it is important that the uterus remain dilated throughout the procedure. Therefore, once fluid is infused into the uterus, it is important to prevent backflow of fluid through the cervix. In yet another embodiment, the medical device 5 includes a shield device 79 operable to sealingly engage the external os of the cervix during the aforementioned procedure. An exemplary embodiment of the shield device 79 includes a shield 80 and a shield device arm 81 secured to the shield 79. The shield device 79 includes a bore operable to slidably engage with the arm 15. The shield device arm 81 is inserted into the cervix, and the shield 80 and arm 81 are operable to prevent backflow through the cervical os. Other exemplary embodiments of the shield device 79 are discussed in FIGS. 15-17.

[0025] 8-19, another embodiment of the present invention is shown. For purposes of this application, other embodiments and components of medical device 100 disclosed in Figures 8-19 that are applicable herein may be incorporated into the preferred embodiment of medical device 5 disclosed in Figures 1-7.

[0026] As shown in FIG. 8 , the medical device 100 includes a body 102 having a handle end 104 opposite an arm end 106. The body 102 can be made of a material such as metal, plastic, or carbon fiber. A handle 108 is defined by the body 102. An arm 112 is connected to the body 102. In one embodiment, the handle 108 is offset from the longitudinal plane of the arm 112. The arm 112 has a proximal end 114 opposite a distal end 116. The arm 112 can be made of a flexible material, such as a polymer, thermoplastic, or thermoset material. In embodiments made of a flexible material, the arm 112 is maneuverable so that it can be bent and shaped to allow a physician to target an area in any plane within the patient's uterus for scraping. In another embodiment, the arm 112 can be made of a rigid material, such as metal, plastic, or carbon fiber. Markings 113 indicate the depth of the device 100 within the patient's body and can be applied to any embodiment disclosed herein.

[0027] In one alternative embodiment, as shown in FIGS. 8-9 , the medical device 100 includes an alternative means for retaining the dispersed fluid throughout the medical device. The body 102 of the medical device 100 defines a cartridge port 166 operable to receive and secure a fluid cartridge, such as a saline or dye cartridge 168. The body 102 may include a hinged or sliding door 182 for accessing the cartridge port 166. The body 102 may be fabricated from a transparent material to allow viewing of the saline cartridge 168. A pump 170 is operable to pump saline from the cartridge 168 through the fluid passageway 134 and into the patient's body. The pump 170 is powered by a battery 164 and may be activated by a button 174 electronically connected to the pump 170. In some embodiments, a pull tab 184 is used to activate the battery 164 to power the pump 170. The fluid distribution means disclosed in this paragraph is operable for use with any of the embodiments disclosed herein, including the preferred embodiment described in Figures 1-7, as well as with any type of tip, including an articulating tip 120, a wire 124, an ensnare tip 125, and an inflatable balloon 128, as shown in Figures 8-14. The conduit 118 is defined by an arm 112, as shown in Figure 8. The arm 112 may be, for example, 3 mm in diameter. A high flow output port 119 is disposed at the end of the arm 112 and is operable to receive and discharge fluid flowing through the fluid passageway 134.

[0028] The medical device 100 can be configured with a variety of tips operable to scrape the patient's endometrium. Each type of tip is operable to function with other features of the invention disclosed herein. In one embodiment, as shown in FIG. 8 , an articulating tip 120 is provided. The articulating tip 120 is disposed at the distal end 116 of the arm 112. The handle 108 includes a spring-loaded trigger mechanism 110 operable to curl the articulating tip 120 in various planar directions by squeezing a trigger 122. Preferably, the handle 108 is offset approximately 45° from the longitudinal plane of the arm 112 to facilitate guidance of the arm 112 into the uterine cavity, and the handle 108 is positioned so that the user's index finger (not shown) can easily actuate the trigger 122.

[0029] 9-11 , a wire 124 is provided at the distal end 116. A wire recessed opening 126 is defined by the distal end 116 of the arm 112. The wire 124 is disposed within the conduit 118. The wire 124 is operable to extend through the wire recessed opening 126. A trigger mechanism 110 is disposed within the handle 108 and is operable to retract and extend the wire 124 through the wire recessed opening 126. The trigger mechanism 110 may be spring-loaded, for example. In one embodiment, the wire 124 is operable to bend to form an arc and extend through the wire recessed opening 126.

[0030] In another embodiment, as shown in FIGS. 12-13 , an inflatable balloon 128 is provided at the distal end 116. The inflatable balloon 128 is disposed at the distal end 116 of the arm 112. A trigger mechanism 110 is disposed within the handle 108 and is operable to inflate and deflate the balloon 118. The trigger mechanism 110 may be spring-loaded, for example. The trigger mechanism 110 may inflate the balloon 128 by, for example, air pressure, hydraulic pressure, or injection of fluid from an external syringe. The means for inflating the balloon 128 may be, for example, by a pump included within the device 100 or an external pump attached to the device 100.

[0031] In yet another embodiment, as shown in FIG. 14 , an ensnare tip 125 is provided. An ensnare recessed opening 127 is defined by the distal end 116 of the arm 112. The ensnare tip 125 is operable to retract and compress into the ensnare recessed opening 127, and to extend from the ensnare recessed opening 127. A trigger mechanism 110 is disposed within the handle 108 and operable to extend and retract the ensnare tip 125 from the ensnare recessed opening 127. The trigger mechanism 110 may be, for example, spring-loaded. In embodiments of the medical device 100 including the ensnare tip 125, the ensnare tip 125 compresses upon contact with the patient's endometrium, allowing the practitioner to ease the scraping force on the patient's endometrium, thereby reducing the force applied to the endometrium, as opposed to, for example, a rigid scraping tool. Because thicker wire provides a higher spring force than thinner wire, the gauge of the wire comprising the ensnare tip 125 further cushions the contraction of the ensnare tip 125 when it contacts the endometrium.

[0032] In any of the foregoing embodiments, an indicator may be included in the body 102 and operable to indicate whether the articulating tip 120 is straight or curled, whether the wire 124 or ensnare tip 125 is extended or retracted, or whether the balloon 128 is inflated or deflated. All of the foregoing embodiments of the medical device 100 are configured to include a shield device 140. An additional exemplary embodiment of a shield device 150 is shown in FIGS. 15-17. The shield device arms 144 define an internal bore 154. To accommodate a portion of the contours of the patient's cervix surrounding the external cervical os, the shield 142 may have a concave shape with a concave side and a convex side, with the concave side facing the external cervical os and the convex side facing the vaginal cavity when the medical device 100 is in place.

[0033] In one embodiment, the shield device arms 144 are operable to expand to more closely conform to the internal contours of the patient's cervix. The shield device arms 144 may be expandable, for example, by injecting fluid from a syringe into a port (not shown) on the shield device 140. The shield 142 may be shaped so that the concave side of the shield 142 fits flush against the patient's external cervical os and the cervical tissue surrounding the external cervical os. The curvature of the shield 142 may be adjusted for different patients. The shield device arms 144 may be secured to the concave side of the shield 142. Additionally, the shield 142 may have a generally circular shape, and the shield device arms 144 may be secured to the shield 142 approximately at the center of the shield. Alternatively, the shield 142 may be another shape, such as an oval, suitable for covering the patient's external cervical os.

[0034] The shield device arm 144 may be permanently secured to the shield 142. For example, the shield device arm 144 and the shield 142 may be molded as a unitary piece of material. Alternatively, the shield device arm 144 may be secured to the shield 142 with an adhesive. To facilitate entry and exit of the shield device arm 144 into the patient's cervical canal, the shield device arm 144 may have a generally cylindrical shape. The arm 112 of the medical device 100 is configured to be inserted into the hole 154 of the shield device 140 when the medical device 100 is in use. In one embodiment, the shield device 140 is permanently attached to the arm 112. In one embodiment, the shield device 140 is operable to slide along and be removed from the arm 112.

[0035] As shown in FIG. 15 , the shield device arms 144 can have circumferential bulges 146 to help maintain the device 100 in place when the shield device arms 144 are inserted into the cervical canal during use. The bulges 146 are located along the length of the shield device arms 144 between the midpoint of the shield device arms 144 and the distal end 148 of the shield device. The bulges 146 are preferably located closer to the distal end 148 of the shield device arms 144 than the midpoint of the shield device arms 144. Once the shield device arms 144 are inserted into the cervical canal, the wider diameter of the circumferential bulges 146 provides resistance to removal of the shield device arms 144 from the cervical canal, thereby helping to hold the medical device 100 in place for a period of time after introducing a fluid, such as saline, into the cervical canal or uterine cavity, preventing the medical device 100 from leaking fluid from the cervical canal into the vaginal cavity. The bulge 146 preferably has a contoured surface to prevent discomfort when inserting the shield device arm 144 into the cervical canal.

[0036] The shield device 140 may further include valves 150 disposed at the distal and proximal ends of the shield device arms 144. The valves 150 are operable between an open position and a closed position. When in the closed position, the valves 150 form a substantially fluid-tight seal to prevent leakage of fluid through the valve 150. In the embodiment shown in FIGS. 15-17, the valves 150 are circular valves with small circular openings that allow the arms 112 of the medical device to pass through the valve 150 and form a seal around the arms 112. In another embodiment, the valves 150 include multiple resilient flaps integrally attached to the ends of the shield device arms 144. When the valve 190 is in the closed position, the resilient flaps are resiliently biased against each other in an inward direction toward the center of the hole 154. The resilient flaps are sized and shaped to form a substantially fluid-tight seal over the opening of the hole 154. As used herein, the term "elastomeric" refers to any material that is flexible and / or extensible, such that the material can flex and / or stretch and then return to its original position. In this case, the original position refers to the closed position of the valve. Preferably, valve 150 has three resilient flaps, each having a generally triangular shape. When valve 150 is in the closed position, the three triangular flaps fit together to form a substantially fluid-tight seal to prevent fluid from leaking through valve 150.

[0037] During an HSG procedure and / or an endometrial scraping procedure on a patient's endometrium, the arms 112 of the medical device 100 are inserted through and secured to the shield device 140. When the arms 112 are forced into the holes 154, the arms 112 push through the valve 150, thereby forcing the interior opening of the valve 150 outward and forming a seal around the arms 112. In this manner, the medical device 100 can pass through the shield device 140 to deliver a fluid, such as saline, into the uterine cavity and perform the endometrial scraping. When the shield device 140 is secured against the patient's cervical os, a leak-proof seal is formed and the injected fluid remains within the uterus.

[0038] As shown in FIG. 18 , another embodiment of the present invention incorporating imaging means is shown. Here, an imaging device 156 is integral with the medical device 100. In an embodiment including integrated imaging, ultrasound is not required, as the physician can position and operate the medical device by viewing the video output of the imaging device. The imaging device 156 is located at the distal end 116 of the arm 112 and is operable to transmit images of the interior of the patient's uterus via an electronic connector 158. The imaging device 156 may be, for example, an optical scope, a fiber optic scope, a hysteroscope, or a camera. In one embodiment, an endoscopy system may be utilized as the imaging device 156, which may be a wireless handheld endoscopy system (not shown). Such a system may include, for example, an endoscope cannula, a disposable mount, focus / zoom capabilities, a wireless camera, a 2.4 GHz high-resolution camera used in conjunction with a laptop or other monitor, and imaging and power controls. The electronic connector 158 is disposed within the conduit 118 and is operable to transmit images of the patient's uterus interior to the connection port 160. The conduit 118 is operable to enclose the electronic connector 158, the fluid passageway 134, and a mechanical mechanism for operating the tip. The connection port is defined by the body and is operable to receive images of the patient's uterus from the electronic connector 158 and to transmit the images to a display, such as an attachable screen 186 or a computing device. In one embodiment, the display may be integrally incorporated into the body 102 of the medical device 100. The connection port 160 can be configured to attach to the display. The connection port 160 may be configured to transmit the images via a wired connection, such as Ethernet or USB, or wireless means, such as Bluetooth or Wi-Fi. The connection port 160 may further be operable to transmit the images to a computer-readable medium, such as a flash drive, an external storage drive, or cloud storage.

[0039] In one embodiment, medical device 100 includes a power source 188, such as a battery, or a power cable operable to connect an external power source, operable to provide power to imaging device 156, light source 162, and display 186. Pull tab 190 is operable to activate power source 188. Power source 164 may be, for example, a battery pack, or a power cable operable to connect an external power source. Power source 164 is further operable to provide power to embodiments of the invention, including pump 170.

[0040] As shown in FIG. 11 , the tip 192 can be an articulating tip, a balloon, an ensnare tip, or a wire, as disclosed in FIGS. 1-19 , or any other device suitable for performing curettage inside a patient's uterus. The high-flow output port 119 can be, for example, a hole defined by the arm 112 or a circumferential slit surrounding the periphery of the arm 112. As shown in FIG. 18 , an imaging device 156 is positioned behind the arm's tip 192 to allow a physician to view the tip 192. A rotation knob 155 allows the arm 112 to be rotated to move the tip 192 in a desired plane. In one embodiment, the medical device 100 includes a light source 162 operable to illuminate the interior of the patient's uterus. The light source 162 can be, for example, one or more light-emitting diodes or light-delivery fibers.

[0041] As shown in FIG. 19 , one embodiment of the present invention 200 includes a body 202 defining a syringe cavity 216 having a handle end 218 opposite an arm end 220 and operable to receive and secure a syringe 222. Markings 213 indicate the depth of the device 200 within a patient's body. The syringe 222 can, for example, be snapped into place within the syringe cavity 216. A lock 224 is disposed at the arm end 220 of the syringe cavity 216 and operable to receive and secure a tip 226 of the syringe 216. The lock 224 is operable to form a leak-proof seal between the lock 224 and the tip 226 of the syringe 222. The lock 224 is further operable to allow fluid communication between the tip 226 of the syringe 222 and the fluid input end 215 of the conduit 214. The handle 208 includes a spring-loaded trigger mechanism 228, such as, for example, a finger ring, operable to drive a plunger 230 into the syringe 222 to advance the fluid contained therein. In one embodiment, a mechanical drive device 231 is operable to drive an internal push pad of the plunger 230 into the syringe 222, driving the fluid contained within the syringe 222 through the conduit 214 and out the high flow output port 219 into the patient's uterus and fallopian tubes. An HSG procedure may utilize, for example, 30 cc of dye. The articulating lever 229 is operable to curl the arm 210 in various directions by pulling the articulating lever 229. The medical device 200 may be configured with a variety of tips, such as an articulating tip, a balloon, an ensnare tip, a wire, or other device suitable for scraping the endometrium of a patient's uterus.

[0042] According to an embodiment of the present invention, a method for performing an endometrial scraping and / or HSG procedure using any of the aforementioned embodiments is provided. The method includes the following steps: (a) a first step of providing a defined medical device 5, 100; (b) introducing the medical device 5, 100 into a patient's uterine cavity before ovulation so that a shielding device 79, 140 is firmly positioned against the patient's cervical os to provide a leak-proof seal for fluids injected into the uterus; (c) injecting a fluid, such as saline or dye, into the patient's uterus to fill it and perform the HSG procedure to remove blockages from the patient's fallopian tubes; and / or (d) using ultrasound or x-ray to view the medical device 5, 100 in the patient's fallopian tubes and within the patient's uterus. In an embodiment of the device 5, 100 that includes an imaging device, the physician would use an image of the patient's uterus displayed on the imaging device in step (d) rather than viewing the device by ultrasound or x-ray. The method further includes (e) performing endometrial curettage at the desired location by using an ultrasound, x-ray, or imaging device to position the medical device 5, 100 and actuating the articulating tube, wire, ensnare tip, or balloon as defined herein. The method includes (f) removing 316 the medical device 5, 100 from the patient.

[0043] For any of the foregoing embodiments, some or all of the medical device 100 may be fabricated from a transparent material to allow the physician to see the amount of saline delivered to the patient. Additionally, it may include markings indicating 5cc, 10cc, 15cc, and 20cc, allowing the physician to inject the correct amount of saline to fill the uterus.

[0044] For the purposes of promoting an understanding of the principles of the present invention, reference has been made to preferred embodiments illustrated in the drawings, and specific language has been used to describe these embodiments. However, this specific language is not intended to limit the scope of the present invention, and the present invention should be construed to encompass all embodiments that would normally occur to one of ordinary skill in the art. The specific implementations shown and described herein are illustrative examples of the present invention and are not intended to limit the scope of the present invention in any way. For the sake of brevity, conventional aspects of systems (and components of individual operating components of systems) may not be described in detail. Furthermore, the connecting lines or connectors shown in the various presented figures are intended to represent example functional relationships between various elements and / or example physical or logical couplings between various elements. It should be noted that many alternative or additional functional relationships, physical connections, or logical connections will be present in an actual device. Furthermore, unless an element is specifically described as "essential" or "critical," no item or component is essential to the practice of the present invention. Many modifications and adaptations will be readily apparent to those skilled in the art without departing from the spirit and scope of the present invention.

Claims

1. A medical device configured to perform endometrial scraping and / or HSG procedures, comprising: an arm having a proximal end and a distal end, the arm including a joint lumen disposed within the arm and extending along the length of the arm from the proximal end to the distal end; a handle including a trigger and a fluid cassette disposed within the handle; a flexible joint tube disposed within the joint canal, the flexible joint tube including a bore extending from a first end to a second end; the fluid cassette is in fluid communication with the bore; the medical device further comprising means for pumping fluid from the fluidic cassette through the bore; the trigger is operable to extend the second end of the articulation tube beyond the distal end of the arm and to controllably curl the second end of the articulation tube as the second end of the articulation tube extends beyond the distal end of the arm; The medical device, wherein the distal end of the joint tube is operable to extend beyond the distal end of the arm and to controllably curl up to 90° from the longitudinal axis of the joint tube upon actuation of the trigger and exiting the distal end of the arm.

2. The medical device of claim 1 , including an optical lumen disposed within the arm, the optical lumen configured to receive a scope.

3. a scope having a camera at its distal end and an imaging device including a display screen; the imaging device is mountably attached to the handle; the imaging device is in communication with the scope; The medical device of claim 2 , wherein the image from the camera is displayed on the display screen.

4. The medical device of claim 1 , wherein the joint tube is made from a material having shape memory properties.

5. The medical device of claim 1 , including a rotator operable to rotate the articulation tube along a longitudinal axis.

6. The medical device of claim 5 , including a rotation lock operable to lock the articulation tube in a fixed, extended position.

7. the trigger includes a channel operable to receive the articulation tube; the handle and the trigger form a unitary body integrally connected by an arcuate hinge connection; the trigger is biased away from the handle; the arm is fixedly attached to the trigger; The medical device of claim 1 , wherein when the trigger is pulled proximally toward the handle, the second end of the articulation tube extends beyond the distal end of the arm.

8. The medical device of claim 1, comprising a shield operable to sealingly engage the external cervical os of the cervix, the shield including a hole configured to slidably engage with the arm.

9. The medical device of claim 1, further comprising a conduit defined by the arm.

10. The medical device of claim 9, further comprising a wire recessed opening defined by the distal end of the arm, and a wire disposed within the conduit and operable to extend through the wire recessed opening.

11. The medical device described in claim 10, wherein the trigger is capable of manipulating the wire to extend and retract through the wire recessed opening.

12. The medical device of claim 11, wherein the wire is operable to curl and extend through the wire recessed opening.

13. The medical device of claim 1, wherein the trigger is a spring-loaded trigger.

14. The device described in claim 1, wherein the handle is offset approximately 45° from the longitudinal plane of the arm.

15. The medical device of claim 1, wherein the trigger is operable to curl the articulated arm in various planar directions by actuating the trigger.

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