Devices and methods for improving implantation of a fertilized egg during pregnancy

Abstract

The disclosed invention comprises a device that utilizes a manually controlled articulated arm to apply small, precise abrasions to the inner wall of the uterus prior to ovulation. A preferred embodiment of the invention comprises a handle, an arm having a rigid portion and an articulated distal end, both of which are covered by a non-irritating housing, wherein the handle is connected to the arm via a connecting member containing a trigger mechanism operable to move the articulated distal end by pulling a trigger.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62,814,910, filed on March 7, 2019, and U.S. Provisional Application No. 62,662,253, filed on April 25, 2018. The entire contents of the above applications are incorporated herein by reference in their entirety as if fully set forth herein. Technical Field

[0003] The present invention relates generally to medical devices and, more particularly, to devices and methods for improving the intrauterine environment before and during pregnancy. Background Art

[0004] Artificial reproductive technology ("ART") is not a new concept. Numerous issues exist that may prevent or reduce the likelihood of a successful pregnancy. While ART has led to specific technological advances to address recurring fertility issues in women, little has been done to increase the chances of a fertilized egg successfully implanting itself in the lining of the uterus, a crucial step in the pregnancy process.

[0005] Once the egg is fertilized, it must successfully implant itself in the wall of the uterus to form the placenta, which allows the fertilized egg to obtain necessary nutrients from the mother. Unfortunately, although fertilization may be successful, recurrent implantation failure ("RIF") often occurs in mothers using ART; this failure is usually attributed to abnormalities in the endometrium at the time of implantation or abnormalities in the mother's immune system.

[0006] Currently, doctors intentionally scrape the endometrial lining of the uterus to trigger an inflammatory response in the uterine cavity before ovulation. Following the scraping, the body's natural wound healing response improves the environment of the endometrium and makes it more likely that the embryo will implant and result in a pregnancy.

[0007] Until now, there has been no device suitable for creating precise "scratches" along the endometrial layer of the uterus. Currently, a medical professional will take a catheter or other similar device and blindly advance it until they feel some form of resistance; believing the resistance is caused by the uterine wall, the medical professional will begin scraping. This seemingly outdated and crude way of performing the procedure can result in unnecessary punctures or even complete penetration of the uterine wall.

[0008] Therefore, there is a great need for a device that can be precisely manually controlled and guided into the uterus to avoid unnecessary trauma and injury. Summary of the Invention

[0009] The present invention solves this problem by allowing the physician 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 personnel to make precise, small abrasions on the endometrial wall while avoiding the risk of puncturing or penetrating the uterine wall.

[0010] A preferred embodiment of the invention is shown in the accompanying drawings and comprises a handle, an arm having a rigid portion and an articulated end, both of which are covered by a housing, wherein the handle is connected to the arm by a connecting member, the connecting member comprising a spring-loaded trigger mechanism operable to move the articulated end by pulling the trigger. Preferably, the degree of articulation is proportional to the extent to which the trigger is pulled toward the handle. The proximal end of the arm may also comprise a rotatable knob operable to adjust the planar orientation of the articulated end. Another aspect of the invention is that the outer surface of the arm has measurement markings which serve to inform the physician of the length of the arm that has been inserted into the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 . Figure 1 is a perspective view of the device showing the trigger mechanism contained within the connecting member.

[0012] Figure 2 . Figure 2 is an outline diagram of the device, showing the Figure 1 Opposite side shown.

[0013] Figure 3 . Figure 3 is an exploded view of the device.

[0014] Figure 4 . Figure 4 is a top view of the arm.

[0015] Figure 5 . Figure 5 is a transparent perspective view of the connecting member, showing the trigger mechanism.

[0016] Figure 6 . Figure 6 is a perspective view of the device showing the hinged end in a curled position. DETAILED DESCRIPTION

[0017] Go to Figures 1 to 3A preferred embodiment of the present invention comprises a handle 10, an arm 20 including an articulating distal end 40, wherein the handle 10 is connected to the arm 20 by a connecting member 50, the connecting member 50 containing a spring-loaded trigger mechanism 60 operable to curl the articulating distal end 40 in various planar orientations by pulling a trigger 65. Preferably, the handle 10 is offset approximately 45° from the longitudinal plane of the arm 20 to facilitate guiding the arm 20 into the uterine cavity, and is positioned so that the trigger 65 can be easily actuated by a user's index finger (not shown).

[0018] Go to Figure 4 The articulated tip 40 at the distal end of the arm 20 is made of a material having flexible properties, including but not limited to flexible polymers, solid foams, thermoplastics, thermosetting materials, or other materials known in the art having similar properties. When activated, the articulated tip 40 will curl in a given planar direction, wherein the inner portion of the curled tip 40 will be compressed, while the outer portion of the curled tip 40 will be in a tensioned state (e.g., Figure 6 ). Thus, preferably, the articulating tip 40 will have a larger circumferential slit 75 on an inner portion of the tip 40 and a smaller circumferential slit 85 on an outer portion of the tip 40 to allow the articulating tip 40 to curl.

[0019] The proximal end of the arm includes a rotatable knob 90 that is operable to adjust the planar orientation of the articulating tip 40. A non-flexible portion 100, or rigid portion, of the arm 20 located between the rotatable knob 90 and the articulating tip 40 is made of a substantially rigid material, such as metal or a hardened polymer (e.g., carbon fiber or other plastic), to prevent flexing along the portion 100 of the arm 20. For a preferred embodiment, the rotatable knob 90 includes an indicator, such as an arrow 170, that alerts the user that the articulating tip 40 should be curled in a planar orientation.

[0020] As shown, a cable or wire 110 extends longitudinally from the distal end of the arm 20 and wraps around the spring-loaded trigger mechanism 60 before returning to the distal end of the arm 20, thereby forming a continuous closed loop; a portion of the cable 110 is connected to the trigger mechanism 60 by a slot-pin 120 (e.g., Figure 5) or some other attachment means known in the art is fixedly attached to the trigger mechanism 60. Alternatively, the present invention contemplates the use of at least two separate cables or wires 110 that follow similar paths and are parallel, wherein one end of the wire is fixedly attached to the trigger mechanism 60 and the opposite end of each wire 110 is fixedly attached at the distal end of the arm 20. With either arrangement, when the trigger 65 is actuated, the trigger mechanism 60 causes a portion of the cable 110 to be slack in the arm 20 while the other portion is tightened. This process enables the flexible articulating end 40 to curl in the direction of pulling the cable 110, thereby forming a circular bend (e.g., Figure 6 As shown, the degree of annular curvature produced by the articulated end 40 is proportional to the extent to which the trigger 65 is pulled toward the handle 10. As shown, the outer surface of the trigger mechanism 60 has an arrow 160 that rotates in the opposite direction of the handle 10 when pulled. As a means of alerting the user to the degree of annular curvature, the arrow 160 will correspond to a measurement mark on the outer housing (not shown) of the connecting member 50.

[0021] Go to Figure 3 and Figure 4 The preferred embodiment further includes a sleeve 130 adapted to fit over and completely surround the arm 20; a cap portion 140 of the sleeve 130 covers the distal end of the articulated tip 40. The sleeve may be made of any fabric, polymer, or other material that is flexible and has properties that minimize or do not cause irritation to the patient. Figure 4 As shown in , a preferred embodiment of the cap portion 140 includes a rounded surface to further minimize irritation to the patient when in contact with the endometrial layer of the uterus. Although this embodiment is preferred, it is contemplated that the cap portion 140 may have different sizes, shapes, and materials depending on the needs of the user.

[0022] like Figure 3 As shown, another aspect of the present invention is that the outer surface of the sleeve 130 includes measurement markings 150 that serve to inform the physician of the length of the arm 20 that has been inserted into the patient. Although not required, it is preferred that these markings be spaced in one centimeter increments.

[0023] The subject device is to be positioned inside the uterus to create small, precise abrasions along the uterine endometrial lining. For optimal results, this procedure is performed several days before ovulation; typically, depending on the patient, it occurs on day 7, 8, or 9 of the menstrual cycle. The physician uses handle 10 to guide arm 20 through the cervix and into the patient's uterine cavity until cap portion 140 of articulating tip 40 abuts the endometrial lining of the uterus. Next, when trigger mechanism 60 is actuated by pulling trigger 65 inward a certain distance toward handle 10, articulating tip 40 curls in the direction of the plane set by rotating knob 90, pulling trigger 65 an angular distance proportional to that degree. Articulating tip 40 creates small abrasions on the uterine lining. After the abrasions are created, when handle 10 is slowly released, the spring-loaded trigger mechanism 60 operates to return articulating tip 40 to its resting state, which is longitudinally aligned with rigid portion 100 of arm 20. At this stage, the physician can safely and easily manually remove the arms 20 from the uterine cavity.

[0024] In order to promote the understanding of the principles of the present invention, the preferred embodiments shown in the accompanying drawings have been described, 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 considered to cover all embodiments that a person of ordinary skill in the art would normally think of. The specific embodiments 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, the conventional aspects of the system (and the components of the various operating components of the system) may not be described in detail. In addition, the connecting lines or connectors shown in the various figures presented are intended to represent exemplary functional relationships and / or physical or logical couplings between the various elements. It should be noted that many alternative or additional functional relationships, physical connections or logical connections may exist in actual devices. Moreover, unless an element is specifically described as "essential" or "critical", no item or component is essential for implementing the present invention. Without departing from the spirit and scope of the present invention, many modifications and changes will be apparent to those skilled in the art.

Claims

1. A medical device comprising: a.Handle; b. an arm further comprising a rigid portion and an articulated end, the rigid portion and the articulated end each having a proximal end and a distal end, wherein the distal end of the rigid portion is connected to the proximal end of the articulated end; c. a connecting member further comprising a trigger mechanism; and d. a sleeve comprising a circular cap portion disposed at a distal end of the sleeve such that the sleeve and the circular cap portion form a continuous body, wherein the sleeve and the circular cap portion completely cover the arm, wherein the circular cap portion is configured to cover a distal end of the articulated end of the arm, wherein the handle is connected to the proximal end of the rigid portion of the arm via the connecting member, Wherein, the trigger mechanism is operable to curl the articulated end.

2. The medical device according to claim 1, wherein The handle is offset from the longitudinal plane of the arm.

3. The medical device according to claim 1, wherein The trigger mechanism is spring loaded.

4. The medical device according to claim 1, wherein The articulated end is capable of curling up to 90° from the longitudinal plane of the arm.

5. The medical device according to claim 4, wherein The articulating end includes a circumferential slit.

6. The medical device according to claim 5, wherein The articulating tip has an inner side and an opposing outer side, wherein a circumferential slit along the inner side is wider than a circumferential slit on the outer side.

7. The medical device according to claim 4, wherein The articulating tip is constructed from a flexible material, wherein the flexible material is a polymer.

8. The medical device according to claim 1, wherein The rigid portion of the arm is selected from the group of materials comprising: metal; plastic; or carbon fiber.

9. The medical device according to claim 1, wherein The arm further includes a rotatable knob operable to adjust the plane in which the articulating end curls.

10. The medical device according to claim 9, wherein The rotatable knob also includes an indicator on its exterior surface that marks the direction of the plane in which the hinged end is curled.

11. The medical device according to claim 1, wherein The sleeve is selected from the group of materials having properties of being flexible and non-irritating to human skin.

12. The medical device according to claim 1, wherein The sleeve also includes markings adapted to measure the length of the arm.

13. The medical device according to claim 4, wherein The articulating tip is constructed of a flexible material, wherein the flexible material is a thermoplastic or a thermosetting material.

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