Medical devices for women's reproductive health and their usage

Abstract

A single handheld medical device for performing endometrial abrasion and / or HSG procedures is disclosed. A preferred embodiment includes a body comprising a handle integrally attached to an arm having a hinged member at its distal end. The handle includes means for storing fluid and pumping the fluid into the uterus, such that ultrasound or X-rays can be used to determine the location of the hinged member within the uterus. The arm also includes a shielding device operable to slidably engage the arm of the device, and the shielding and the arm are configured to cover and seal the external os of the cervix to prevent backflow during use. An optional viewing device is disclosed, including an imaging screen mountably attached to the device and communicating with a mirror disposed within the arm.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63,074,096, filed September 3, 2020; U.S. Provisional Patent Application No. 63,110,544, filed November 6, 2020; U.S. Provisional Patent Application No. 63,123,694, filed December 10, 2020; and U.S. Provisional Patent Application No. 63,136,338, filed January 12, 2021. The entire contents of these applications are hereby incorporated by reference, as if fully set forth herein. Technical Field

[0003] This invention generally relates to medical devices used in female reproductive procedures. More specifically, this invention relates to a device and method for improving the intrauterine environment before and during pregnancy. Background Technology

[0004] Assisted reproductive technology (“ART”) is not a new concept. Numerous problems exist that can prevent or reduce the likelihood of a successful pregnancy. While ART has made concrete technological advances to address recurring female fertility issues, it has done little to increase the chances of a fertilized egg successfully implanting itself into the uterine lining—a crucial step in the pregnancy process.

[0005] Once the egg is fertilized, it must then successfully implant itself into the uterine wall so that placental formation can occur, allowing the fertilized egg to receive the necessary nutrients from the mother. Unfortunately, despite the possibility of successful fertilization, mothers using ART often experience repeated implantation failure (“RI F”); this failure is often attributed to abnormalities in the endometrium or the mother’s immune system at the time of implantation.

[0006] Currently, physicians intentionally scrape the lining of the uterus to induce an inflammatory response within the uterine cavity before ovulation. The body's natural wound-healing response after the scraping improves the endometrial environment and makes it more likely for an embryo to implant and result in pregnancy.

[0007] To date, there is no device specifically designed to allow physicians to make precise “scratches” along the uterine lining while simultaneously observing the device’s position within the patient’s body. Currently, medical professionals will pick up a catheter or some other similar device and blindly push it forward until they feel some form of resistance; believing the resistance is caused by the uterine wall, the medical professional will begin scraping. This seemingly ancient and barbaric method of performing the procedure results in unnecessary deep punctures, or even complete perforation of the uterine wall.

[0008] When a patient's fallopian tubes are clear of blockages, the chances of a successful pregnancy increase. A hysterosalpingography (HSG) is an X-ray procedure performed on a woman to check if her fallopian tubes are open and if the inside of her uterus is normal. HSG is an outpatient procedure that typically takes less than 5 minutes. It is usually performed after menstruation has ended but between ovulation.

[0009] In a typical HSG procedure, the woman is positioned under a fluoroscope (an X-ray imaging device that takes pictures during the study) on a table. A gynecologist or radiologist then examines the patient's uterus and inserts a speculum into her vagina. Her cervix is ​​cleaned, and a device (cannula) is placed into the opening of the cervix. The doctor gently fills the uterus with an iodine-containing fluid (a fluid visible to X-rays) through the cannula. The contrast agent will appear white on the image, and the outline of the uterus can be seen as the fluid travels from the cannula into the uterus and through the fallopian tubes. As the contrast agent enters the fallopian tubes, it outlines the length of the fallopian tubes and overflows from their ends when they are patent. Abnormalities inside the uterine cavity can also be detected by the doctor viewing the X-ray images if the fluid movement is abnormally disturbed. Typically, a side view of the uterus and fallopian tubes is obtained by having the woman change her position on the table. This procedure usually requires the doctor to use multiple tools simultaneously, such as positioning all the tubing, syringes, and devices to prevent dye leakage while viewing the fallopian tubes on X-ray.

[0010] Typically, HSG procedures are performed separately from procedures that create abrasions in the uterine lining. This requires the patient to undergo two procedures and medical staff to use multiple instruments. These existing procedures also require multiple hands to work simultaneously to control the various instruments involved. Accordingly, there is a strong need for a single device that can be manually controlled with one hand and precisely guided into the uterus to avoid unnecessary trauma and damage while clearing blockages from the patient's fallopian tubes. Summary of the Invention

[0011] This invention addresses existing problems in the technology by allowing physicians to carefully guide the device through the cervix and into the uterine cavity. Additionally, once in the uterus, the device's articulated arms allow medical professionals to make precise, minor abrasions on the endometrial wall while avoiding the risks of puncture or perforation of the uterine wall.

[0012] The disclosed medical device allows a user to perform abrasion and / or HSG procedures while controlling the instrument with one hand. A preferred embodiment includes a body comprising a handle integrally connected to an arm housing a hinge tube. The handle includes a fluid cartridge in communication with the hinge tube and a trigger. When the trigger is actuated, the hinge tube is operable to curl beyond the distal end of the arm. The handle also includes means for pumping fluid from the cartridge through the hinge tube. The arm further includes a shielding device operable to slidably engage the arm of the device, and the shield and the arm are configured to cover and seal the external os of the cervix to prevent backflow during use.

[0013] Alternative embodiments of the medical device include a digital viewing device comprising a viewing screen using a flexible mirror disposed within the arm of the medical device and a viewing screen mountably attached to the body of the device.

[0014] Alternative embodiments of the medical device include other devices for performing abrasions, including retractable balloons, snare ends, or wires.

[0015] Alternative embodiments of the invention include methods for performing precise endometrial abrasion and / or HSG procedures using the disclosed medical devices. Attached Figure Description

[0016] Figure 1 This is an isometric view of a medical device according to a preferred embodiment of the present invention, showing the hinge tube in the retracted position.

[0017] Figure 2 This is an isometric view of a medical device according to a preferred embodiment of the present invention, showing the hinge tube in its extended position.

[0018] Figure 3 This is an alternative isometric view of a medical device according to a preferred embodiment of the invention, showing the hinge tube in an extended position.

[0019] Figure 4 This is a side view of a medical device according to a preferred embodiment of the present invention, showing the hinge tube in its extended position.

[0020] Figure 5 This is a top view of a medical device according to a preferred embodiment of the present invention, showing the hinge tube in its extended position.

[0021] Figure 6 This is a cross-sectional view of a medical device according to a preferred embodiment of the present invention, showing the cavity disposed within the arm.

[0022] Figure 7 This is an exploded view of a medical device according to a preferred embodiment of the present invention.

[0023] Figure 8 This is a side view of an alternative embodiment of the present invention.

[0024] Figure 9 This is a side view of an alternative embodiment of the invention, showing the end of the wire.

[0025] Figure 10 This is a perspective view of an alternative embodiment of the invention, showing the end of the wire in the retracted position.

[0026] Figure 11 This is a perspective view of an alternative embodiment of the invention, showing the end of the wire in an extended position.

[0027] Figure 12 This is a side view of an alternative embodiment of the invention, showing the tip of the inflatable balloon in the extended position.

[0028] Figure 13 This is a perspective view of an alternative embodiment of the invention, showing the tip of the inflatable balloon in the extended position.

[0029] Figure 14 This is a side view of an alternative embodiment of the invention, showing the end of the snare.

[0030] Figure 15 This is a cross-sectional view of a shielding device according to an embodiment of the present invention.

[0031] Figure 16 This is a top view of a shielding device according to an embodiment of the present invention.

[0032] Figure 17 This is a bottom view of a shielding device according to an embodiment of the present invention.

[0033] Figure 18 This is a side cross-sectional view of a medical device with an imaging apparatus according to an embodiment of the present invention.

[0034] Figure 19 This is a side view of a medical device that surrounds a syringe and has a hinged end according to an embodiment of the present invention. Detailed Implementation

[0035] Turning Figures 1 to 7 A preferred embodiment of medical device 5 is shown. For example... Figures 1 to 2 As shown, the medical device 5 includes an integral body 10, which includes a handle 35 attached to the arm 15 via a bow-shaped hinge connection 45.

[0036] Arm 15 has a proximal end 20 and a distal end 25, wherein a hinged cavity 30 is disposed in the arm. Figure 6And extends along the length of arm 15 from proximal end 20 to distal end 25. The articulated cavity 30 is operable to receive an open first end and an opposing open second end 52. Figure 6 The arm 15 and the hinged tube 50 have an internal bore extending their entire length. Both the arm 15 and the hinged tube 50 must be made of a material with sufficient flexibility to allow a physician or user to guide the arm through the vagina, cervix, and into the uterus.

[0037] Handle 35 includes trigger 40 and cartridge port 60 configured to receive fluid cartridge 61. The first end of hinge tube 50 is preferably in fluid communication with fluid cartridge 61 via connecting tube 64 having quick-connect fastener 65, as... Figure 4 As seen in the previous embodiment. The handle 35 also includes a hinged handle 62 operable to secure the fluid cartridge 61 in place. The hinged handle 62 may form an integral part of the handle 35 or may be removably attached to the handle 25. Alternatively, as seen in the preferred embodiment, the hinged handle 62 may be U-shaped and include an ergonomically designed plunger 66 configured for easy actuation by a user's hand while holding the handle 35. When the user squeezes the plunger 66, an inward force is directed to the sac-like structure 63 disposed on the fluid cartridge 61, causing fluid to be squeezed from the fluid cartridge 61 through the connecting tube 64 into the first end of the hinged tube 50, and fluid will flow from the open second end 52 (…). Figure 6 )spread.

[0038] The proximal end 20 of arm 15 is fixedly attached to trigger 40 such that when trigger 40 of handle 25 is pulled proximally toward handle 25, hinge tube 50 extends beyond the distal end 25 of arm 15. A second end 51 of hinge tube 50 is operable in the extended position ( Figure 2 The tube is rolled up to ninety degrees from the longitudinal axis of the hinge tube and is flexible enough to be in the retracted position. Figure 1 The trigger 40 retracts into the hinged cavity 30. For example, the hinge tube 50 can be made of a material with shape memory properties, including, for example, a nickel-titanium alloy (or "NiTi"). The bow-shaped hinge connection 45 is made of a semi-rigid, flexible material (e.g., TR-90 nylon) that allows the bow-shaped hinge connection to maintain its shape but also to flex when the trigger 40 is pulled. For embodiments where the trigger and handle are not integrated, any hinge connection can be used, as long as it allows axial movement of the arm 15 via the hinge tube 50.

[0039] In another embodiment of the invention, the medical device 5 includes a rotator 55 operable to rotate the articulated tube 50 along its longitudinal axis, such that a second end 52 of the articulated tube 50 is allowed to articulate when in an extended, curled position. Figures 1 to 2As shown, the rotator 55 is preferably positioned close to the handle 35 so that the user can activate the rotator 55 with his thumb or other fingers while maintaining control of the device 5 with his hand.

[0040] In another embodiment of the invention, the medical device 5 includes a rotary lock 56. When actuated, the rotary lock 56 locks the articulated tube 50 in a specific extended position while allowing the articulated tube 50 to rotate freely. The rotary lock 56 allows the user to disengage from the trigger 40, thereby allowing the user to focus on the surgery without having to apply a constant force to the trigger 40.

[0041] When performing abrasion on the endometrium of the uterus, it is crucial to know the position of the second end 52 of the hinge tube 50 relative to the endometrium of the uterus. One way to accomplish this is by dispersing a fluid or dye into the uterus so that it can be viewed with ultrasound or via X-ray. For either method, the ultrasound dye or fluoroscopy can be a fluid contained in the fluid cartridge 61.

[0042] Alternative embodiments of medical device 5 include an additional imaging device that allows the user to know the position of the hinge tube 50 within the uterus. For example... Figure 6 As shown, arm 15 may include an additional optical cavity 71. (Steering) Figure 7 The optical cavity 71 is adapted to receive a flexible mirror 75 (e.g., an optical mirror, fiber optic mirror, or hysteroscope) having a camera positioned 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 mirror 75. To enhance viewing capability while maintaining the device 5, an imaging screen 76 is mountably attached to the body 10. The imaging screen 76 communicates with the mirror 75 such that the image displayed through the mirror 75 is enhanced on the imaging screen 76.

[0043] When the uterus is dilated for visualization under X-ray or ultrasound, or alternatively during a HSG procedure, it is crucial that the uterus remain dilated throughout the duration of the procedure. Therefore, it is important to prevent backflow of fluid from the cervix when fluid is injected into the uterus. In another embodiment, the medical device 5 includes a shielding device 79 operable to seal the external os of the cervix during the aforementioned procedure. An exemplary embodiment of the shielding device 79 includes a shield 80 and a shielding device arm 81 fastened to the shield 79. The shielding device 79 includes a bore operable to slidably engage the arm 15. The shielding device arm 81 is inserted into the cervix, and the shield 80 and arm 81 are operable to prevent backflow from the cervical os. Figures 15 to 17 Other exemplary embodiments of the shielding device 79 are discussed below.

[0044] Turning Figures 8 to 19Alternative embodiments of the invention are shown. For the purposes of this application, where applicable, Figures 8 to 19 Other embodiments and components of the medical device 100 disclosed herein may be incorporated into Figures 1 to 7 The preferred embodiment of the medical device 5 disclosed herein.

[0045] like Figure 8 As shown, the medical device 100 includes a body 102 having a handle end 104 opposite to an arm end 106. The body 102 may 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 attached to the body 102. In one embodiment, the handle 108 is offset from a longitudinal plane of the arm 112. The arm 112 has a proximal end 114 opposite to a distal end 116. For example, the arm 112 may be made of a flexible material such as a polymer, thermoplastic, or thermosetting material. In embodiments made of a flexible material, the arm 112 is operable to be bent and shaped so that a physician can aim at an area for abrasion in any plane within the patient's uterus. In another embodiment, for example, the arm 112 may be made of a rigid material such as metal, plastic, or carbon fiber. Markers 113 indicate the depth of the device 100 within the patient and may be applicable to any embodiment disclosed herein.

[0046] In an alternative embodiment, such as Figures 8 to 9 As illustrated, medical device 100 includes alternative means for maintaining a dispersed fluid through the medical device. A body 102 of medical device 100 defines a cartridge port 166 operable to receive and secure a fluid cartridge, such as a saline solution or dye cartridge 168. Body 102 may include a hinge or sliding door 182 for access to the cartridge port 166. Body 102 may be made of a transparent material to allow viewing of the saline solution cartridge 168. Pump 170 is operable to pump a saline solution from cartridge 168 through a fluid channel 134 and into the patient. Pump 170 may be powered by a battery 164 and activated by a button 174 electronically connected to pump 170. In some embodiments, a pull tab 184 is used to activate battery 164 to power pump 170. The fluid dispersion means disclosed in this paragraph are operable with any embodiment of the embodiments disclosed herein (including...). Figures 1 to 7 The preferred embodiment described herein) and with any type of end (including articulated end 120, wire 124, loop end 125 and inflatable balloon 128, such as Figures 8 to 14 Used together (as shown in the diagram). Figure 8 The conduit 118 shown in the figure is defined by an arm 112. For example, the diameter of the arm 112 may be 3 mm. A high-flow-rate output port 119 is located at one end of the arm 112 and is operable to receive and discharge fluid flowing through the fluid passage 134.

[0047] The medical device 100 may be configured with various ends operable to ablate the endometrium of a patient's uterus. Each type of end is operable to function in conjunction with other features of the invention disclosed herein. In one embodiment, such as Figure 8 As illustrated, a hinged end 120 is provided. The hinged end 120 is located at the distal end 116 of the arm 112. The handle 108 includes a spring-loaded trigger mechanism 110 operable to curl the hinged end 120 in various planar directions by pulling the trigger 122. Preferably, the handle 108 is offset from the longitudinal plane of the arm 112 by approximately 45° to allow easier guidance of the arm 112 into the uterine cavity, and the handle 108 is positioned such that the user's index finger (not shown) can easily actuate the trigger 122.

[0048] In alternative embodiments, such as Figures 9 to 11 As illustrated, a wire 124 is disposed at the distal end 116. A wire recessed aperture 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 aperture 126. A triggering mechanism 110 is disposed within the handle 108 and operable to extend and retract the wire 124 through the wire recessed aperture 126. For example, the triggering mechanism 110 may be spring-loaded. In one embodiment, the wire 124 is operable to coil into an arc and extend through the wire recessed aperture 126.

[0049] In another embodiment, such as Figures 12 to 13 As illustrated, an inflatable balloon 128 is located at the distal end 116 of the arm 112. A trigger mechanism 110 is located within the handle 108 and is operable to inflate and deflate the balloon 118. For example, the trigger mechanism 110 may be spring-loaded. For example, the trigger mechanism 110 may inflate the balloon 128 pneumatically, hydraulically, or by injecting fluid from an external syringe. For example, the means for inflating the balloon 128 may be a pump included within the device 100 or an external pump attached to the device 100.

[0050] In yet another embodiment, such as Figure 14As illustrated, a snare end 125 is provided. A snare recessed aperture 127 is defined by a distal end 116 of an arm 112. The snare end 125 is operable to retract into and be compressed within the snare recessed aperture 127, and is operable to expand upon extension from the snare recessed aperture 127. A triggering mechanism 110 is disposed within a handle 108 and operable to extend and retract the snare end 125 from the snare recessed aperture 127. For example, the triggering mechanism 110 may be spring-loaded. For example, embodiments of the medical device 100 including the snare end 125 allow medical personnel to mitigate the force of abrasion on a patient's endometrium because the snare end 125 will compress upon contact with the patient's endometrium, thereby reducing the force applied to the endometrium as opposed to rigid abrasion tools. The gauge of the wire at the end of the snare 125 further mitigates the contraction of the end of the snare 125 upon contact with the endometrium, because the thicker wire will provide a higher spring force than the thinner wire.

[0051] For any of the embodiments described above, an indicator may be included on the body 102 and operable to indicate whether the articulated end 120 is straight or curled, whether the wire 124 or the loop end 125 is extended or retracted, or whether the balloon 128 is inflated or constricted.

[0052] All of the foregoing embodiments of medical device 100 are configured to include shielding device 140. Figures 15 to 17 An additional exemplary embodiment of the shielding device 150 is shown. The shielding device arm 144 defines an internal bore 154. To accommodate the contour of the cervical portion surrounding the external os of the cervix of a patient, the shield 142 may have a concave shape including a concave side and a convex side, wherein, when the medical device 100 is in place, the concave side of the shield 142 faces the external os of the cervix and the convex side faces the vaginal cavity.

[0053] In one embodiment, the shielding device arm 144 is operable to expand to further conform to the internal contours of the patient's cervix. For example, the shielding device arm 144 can expand by injection from a syringe into a port (not shown) on, for example, the shielding device 140. The shield 142 can be shaped such that the concave side of the shield 110 mates flush with the external os of the patient's cervix and the cervical tissue surrounding the external os. The curvature of the shield 142 can be adjusted for different patients. The shielding device arm 144 can be fastened to the concave side of the shield 142. Alternatively, the shield 142 can have a generally circular shape, and the shielding device arm 144 can be fastened to the shield 142 generally at the center of the shield. Alternatively, the shield 142 can have another shape suitable for covering the external os of the patient's cervix, such as an oval shape.

[0054] The shielding device arm 144 can be permanently fastened to the shield 142. For example, the shielding device arm 144 and the shield 142 can be molded as a single material part. Alternatively, the shielding device arm 144 can be fastened to the shield 142 with an adhesive. To facilitate easy entry and exit of the shielding device arm 144 from the patient's cervical canal, the shielding device arm 144 can have a generally cylindrical shape. The arm 112 of the medical device 100 is configured to be inserted into the bore 154 of the shielding device 140 when the medical device 100 is in use. In one embodiment, the shielding device 140 is permanently fixed to the arm 112. In one embodiment, the shielding device 140 is operable to slide along the arm 112 and be removed from the arm.

[0055] like Figure 15 As illustrated, the shielding device arm 144 may have a circumferential protrusion 146 to help hold the device 100 in place during use, when inserted into the cervical canal. The protrusion 146 is positioned along the length of the shielding device arm 144 between its midpoint and distal end 148, and may preferably be positioned closer to the distal end 148 than to its midpoint. Once the shielding device arm 144 is inserted into the cervical canal, the wider diameter of the circumferential protrusion 146 provides resistance to removal of the shielding device arm 144 from the cervical canal, thereby helping to hold the medical device 100 in place for a period of time after fluids such as saline solution have been introduced into the cervical canal or uterine cavity, preventing fluid leakage from the cervical canal into the vaginal cavity. The protrusion 146 preferably has a contoured surface to prevent discomfort during insertion of the shielding device arm 144 into the cervical canal.

[0056] The shielding device 140 may also include valves 150 disposed at the distal and proximal ends of the shielding device arm 144. Valve 150 is operable between an open position and a closed position. When in the closed position, valve 150 forms a substantially leak-proof seal to prevent fluid leakage through valve 150. Figures 15 to 17In the embodiment illustrated herein, valve 150 is a circular valve with a small circular opening, allowing the arm 112 of the medical device to pass through valve 150 to form a seal around the arm 112. In another embodiment, valve 150 includes a plurality of elastomeric flaps integrally attached to the end of the shielding device arm 144. When valve 150 is in the closed position, the elastomeric flaps are elastically biased inward toward the center of bore 154 and abut against each other. The elastomeric flaps are sized and shaped to form a substantially fluid-impermeable seal over the opening of bore 154. As used herein, the term "elastomeric" refers to any flexible and / or stretchable material 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 elastomeric flaps, each of which has a generally triangular shape. When valve 150 is in the closed position, the three triangular flaps are assembled together to form a substantially fluid-impermeable seal to prevent fluid leakage through valve 150.

[0057] During the procedure of HSG and / or endometrial abrasion of the patient's endometrium, the arm 112 of the medical device 100 is inserted through and secured to the entire shielding device 140. When the arm 112 is pushed through the bore 154, it is forced through the valve 150 and thus forces the internal opening of the valve 150 outward to form a seal around the arm 112. In this way, the medical device 100 can deliver fluids such as saline solutions into the uterine cavity and perform endometrial abrasion through the shielding device 140. With the shielding device 140 close to the patient's cervix, a leak-proof seal is formed and the injected fluid remains in the uterus.

[0058] like Figure 18The illustration shows an alternative embodiment of the invention incorporated into an imaging device. Here, the imaging device 156 is integrated with the medical device 100. Embodiments including integrated imaging eliminate the need for ultrasound, as the physician can locate and operate the medical device by viewing the video output of the imaging device. The imaging device 156 is positioned on the distal end 116 of arm 112 and is operable to transmit images of the patient's uterine cavity via an electronic connector 158. For example, the imaging device 156 may be an optical endoscope, fiber optic endoscope, hysteroscope, or camera. In one embodiment, an endoscope system may be used as the imaging device 156 and is a wireless handheld endoscope system (not shown). Such a system may include an endoscopic cannula, a disposable support, focusing / zoom functionality, a wireless camera (e.g., a 2.4 GHz high-resolution camera used with a laptop computer or other monitor), and controls for imaging and power supply. The electronic connector 158 is disposed within catheter 118 and operable to transmit images of the patient's uterine cavity to a connection port 160. Catheter 118 is operable to surround the electronic connector 158, a fluid channel 134, and mechanical mechanisms for operating the distal end. The connection port may be defined by the body and operable to receive images of the patient's uterus from the electronic connector 158 and operable 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 integrated into the body 102 of the medical device 100. The connection port 160 may be configured to attach to the display. The connection port 160 may be configured to transmit images via a wired connection, such as Ethernet or USB, or a wireless means, such as Bluetooth or Wi-Fi. The connection port 160 may be further operable to transmit images to a computer-readable medium, such as a flash drive, external storage drive, or cloud storage.

[0059] In one embodiment, the medical device 100 includes a power supply 188 operable to power an imaging device 156, a light source 162, and a display 186, such as a battery or a cable operable to connect to an external power supply. A pull tab 190 is operable to activate the power supply 188. For example, the power supply 164 may be a battery pack or a cable operable to connect to an external power supply. The power supply 164 is further operable to power embodiments of the invention including a pump 170.

[0060] refer to Figure 11 The end 192 can be like this Figures 1 to 19 The articulated end, balloon, snare end, or wire disclosed herein, or any other device suitable for performing abrasions on the interior of a patient's uterus. For example, the high-flow output port 119 may be an aperture defined by arm 112 or a circumferential slit around the circumference of arm 112. Figure 18As shown, the imaging device 156 is positioned behind the end 192 of the arm so that the physician can see the end 192. Rotating the knob 155 allows the arm 112 to rotate to move the end 192 into a desired plane. In one embodiment, the medical device 100 includes a light source 162 operable to illuminate the interior of a patient's uterus. For example, the light source 162 may be one or more light-emitting diodes or optical fibers.

[0061] Turning Figure 19 One embodiment 200 of the invention 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. A marker 213 indicates the depth of the device 200 within the patient's body. For example, the syringe 222 can be engaged in the appropriate position 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 the end 226 of the syringe 216. The lock 224 is operable to form a leak-proof seal between the lock 224 and the end 226 of the syringe 222. The lock 224 is further operable to allow fluid communication between the end 226 of the syringe 222 and a fluid inlet 215 of a catheter 214. For example, the handle 208 includes a spring-loaded trigger mechanism 228, such as a ring, operable to drive a plunger 230 into the syringe 222 to advance fluid contained within the syringe 222. In one embodiment, the mechanical actuator 231 is operable to drive the internal push plate of the plunger 230 into the syringe 222 and drive the fluid contained within the syringe 222 through the conduit 214, exiting the high-flow output port 219, and into the patient's uterus and fallopian tubes. For example, 30 cc of dye may be used in an HSG procedure. The articulated rod 229 is operable to coil the arm 210 in various directions by pulling the articulated rod 229. The medical device 200 may be configured with various ends, such as articulated ends, balloons, snare ends, wires, or any other suitable device operable to abrade the endometrium of the patient's uterus.

[0062] According to embodiments of the present invention, a method is provided for performing endometrial abrasion and / or HSG procedures using any of the embodiments described above. The method includes the following first steps: (a) providing medical devices 5, 100 as defined herein; (b) introducing medical devices 5, 100 into the patient's uterine cavity prior to ovulation, such that shielding devices 79, 140 are securely positioned at the patient's cervix to provide a leak-proof seal for fluid injected into the uterus; (c) injecting a fluid, such as a saline solution or dye, into the patient's uterus to fill the uterus for performing the HSG procedure and to remove blockages from the patient's fallopian tubes; and / or (d) using ultrasound or X-rays to view the patient's fallopian tubes and the medical devices 5, 100 within the patient's uterus. In embodiments including devices 5, 100 with imaging capabilities, the physician will use images of the patient's uterus displayed on the imaging device in step (d) instead of viewing the device via ultrasound or X-rays. The method further includes the step (e) of using ultrasound, X-ray, or imaging equipment to position medical devices 5, 100 to perform endometrial abrasion at a desired location, as defined herein, via an actuating hinge tube, wire, snare tip, or balloon. The method includes the step (f) 316 of removing medical devices 5, 100 from the patient.

[0063] For any of the foregoing embodiments, part or all of the medical device 100 may be made of a transparent material to allow the physician to view the amount of saline solution being injected into the patient. Additionally, markers indicating 5cc, 10cc, 15cc, and 20cc may be included. This will allow the physician to inject the correct amount of saline solution to fill the uterus.

[0064] To facilitate understanding of the principles of the invention, reference is made to the preferred embodiments illustrated in the accompanying drawings, and specific language has been used to describe these embodiments. However, this specific language is not intended to limit the scope of the invention, and the invention should be interpreted as encompassing all embodiments that would not normally evoke the mind of one skilled in the art. The specific embodiments shown and described herein are illustrative examples of the invention and are not intended to further limit the scope of the invention in any way. For brevity, conventional aspects of the system (and components in the various operating parts of the system) may not be described in detail. Furthermore, the connection lines or connectors shown in the various drawings are intended to represent exemplary functional relationships and / or physical or logical connections between various elements. It should be noted that many alternative or additional functional relationships, physical connections, or logical connections may exist in the actual device. Moreover, no item or component is essential to the practice of the invention unless the element is specifically described as "essential" or "critical." Many modifications and adaptations will be readily apparent to one skilled in the art without departing from the spirit and scope of the invention.

Claims

1. A medical device comprising: An arm having a proximal end and a distal end, wherein a hinged cavity is disposed within the arm and extends from the proximal end to the distal end. The handle includes a trigger and a removable fluid cartridge disposed within the handle. A hinged tube, the hinged tube including a bore extending from a first end to a second end and disposed within the hinged cavity. An electric pump system, comprising a power supply and a button, wherein the button is configured to activate the electric pump system. The fluid box is in fluid communication with the bore. The electric pump system is operable to pump fluid from the fluid cartridge through the bore. The trigger is operable to cause the second end of the hinge tube to extend beyond the distal end of the arm. The distal end of the arm is operable to curl in an upward direction as it leaves the distal end of the arm.

2. The medical device of claim 1, comprising an optical cavity disposed within the arm, wherein, The optical cavity is configured as a receiving mirror.

3. The medical device of claim 2, comprising a mirror having a camera at its distal end and an imaging device including a viewing screen, wherein, The imaging device is mountably attached to the handle, wherein the imaging device communicates with the mirror, and wherein a view from the camera is displayed on the viewing screen.

4. The medical device as described in claim 1, wherein, The hinge tube is made of a material with shape memory properties.

5. The medical device of claim 1, further comprising a rotator operable to rotate the articulated tube along a longitudinal axis.

6. The medical device of claim 5, further comprising a rotary lock operable to lock the articulated tube in a fixed extended position.

7. The medical device as claimed in claim 1, wherein, The trigger includes a channel operable to receive the hinge tube, and wherein the handle and the trigger are molded together by an arcuate hinge operable to flex between a first position and a second position. In the first position, the trigger is biased away from the handle. In the second position, the trigger is pulled proximally toward the handle, thereby allowing the second end of the hinge tube to extend beyond the distal end of the arm, and The arm is fixedly attached to the trigger.

8. The medical device of claim 1, comprising a shield operable to sealably engage the external opening of the cervix, the shield including a bore configured to slidably engage the arm.

Images