METHOD OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 62/325,125 filed April 20, 2016, which is hereby incorporated by reference in its entirety.

BACKGROUND

A. Field

[0002] This disclosure relates generally to intrauterine adhesion barrier (IUAB) devices and more particularly to an IUAB device for preventing adhesion reformation.

B. Description of Related Art

[0003] Asherman's syndrome refers to symptomatic intra-uterine adhesions that form most commonly as a result of gravid or non-gravid curettage or infection, and is a significant source of infertility and recurrent miscarriages. Uterine curettage ("D&C") is the most common cause of Asherman's syndrome, particularly when performed shortly after a pregnane}'.

[0004] The treatment for Asherman Syndrome is hysteroscopic adhesiolysis. The uterine cavity is distended with fluid media and the adhesions are divided with scissors. The uterine cavity is generally in the shape of a triangle. It is a virtual space since the anterior and posterior walls are in direct contact.

[0005] Because the anterior and posterior walls are again in direct contact immediately after lysis of adhesions, recurrence of the adhesions during subsequent healing is common. In an effort to prevent recurrence, it is recommended that a mechanical barrier be placed into the uterus for a number of days immediately after lysis of intrauterine adhesions. Clinicians frequently insert a "stent" into the uterine cavity to keep the anterior and posterior walls separated immediately following lysis of adhesions. Several different stents are currently used to reduce recurrence.

[0006] In the past, an intrauterine device (IUD) was used as a stent. However, because of the profile of IUDs, none of them prevented contact between the majority of the anterior and posterior wall of the uterus.

[0007] Currently, balloons catheters are the most common intrauterine stents used for prevention of reformation of intrauterine adhesions after hysteroscopic lysis. One example is the Foley catheter, which is an elastic balloon catheter designed for continuous drainage of the urinary bladder. However, because of the spherical shape of the Foley balloon, it does not effectively separate the uterine walls in the upper areas of the triangle shaped uterine cavity. In addition, distension of the uterine cavity by the balloon often results in significant uterine cramping and occasionally extrusion of the catheter. Further, the 4-5 mm diameter of the catheter extending through the cervix into the vagina is associated with an increased risk of ascending infection.

[0008] To improve upon this, a heart-shaped balloon uterine stent was developed for preventing post-operative recurrence of intrauterine adhesions. The heart shape is designed to more effectively separate the uterine walls both in the lower and upper areas. However, because of the shape, it is more difficult to place into the uterus than a Foley catheter, and is relatively painful to remove. Like the Foley catheter, the heart-shaped balloon stent is associated with uterine cramping in many women due to uterine distension. The 3 mm stem is likely to increase the risk of ascending infection, and thus prophylactic antibiotics are recommended while in place.

[0009] Thus, it would be desirable to provide an improved intrauterine stent to prevent reformation of intrauterine adhesions after hysteroscopic lysis. Specifically, the intrauterine stent should be relatively easy to insert, prevent apposition of the majority of the anterior and posterior uterine walls, minimally distend the uterine cavity to decrease discomfort and the risk of being expelled, minimize the risk of ascending intrauterine infection, and minimize discomfort during removal.

SUMMARY

[0010] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[0011] In one aspect, an intrauterine adhesion barrier (IUAB) device is disclosed. The IUAB device includes a frame having a vertical member and a horizontal member, and at least one flexible member attached to the vertical member and to the horizontal member. The vertical member has a first end and a second end, and the horizontal member has a first end, a second end, and a middle portion. The first end of the vertical member extends from the middle portion of the horizontal member, and the first end and the second end of the horizontal member extend outwardly from the vertical member.

[0012] In another aspect, an intrauterine adhesion barrier (IUAB) device includes a frame including a vertical member and a horizontal member, a first flexible member attached to the vertical portion at two attachments points and to the horizontal portion at one attachment point, a second flexible member attached to the vertical portion at two attachments points and to the horizontal portion at one attachment point, and a retrieval element. The vertical member having a first end and a second end, and the horizontal member having a first end, a second end, and a middle portion. The retrieval element is attached to the second end of the vertical member. The first end of the vertical member extends from the middle portion of the horizontal member, and the first end and the second end of the horizontal member extend outwardly from the vertical member. [0013] In yet another aspect, a method of inserting an intrauterine adhesion barrier device into a patient is provided. The method includes providing an intrauterine adhesion barrier device having a frame with a vertical member and a horizontal member, and at least one flexible member attached to the vertical member and to the horizontal member. The vertical member has a first end and a second end, and the horizontal member has a first end, a second end, and a middle portion. The first end of the vertical member extends from the middle portion of the horizontal member, and the first end and the second end of the horizontal member extend outwardly from the vertical member. The method further includes providing an insertion tube with an internal diameter equal to or larger than that of an external diameter of the 1UAB device, inserting the insertion tube into a uterus of a patient, pushing the IUAB device through the insertion tube, removing the insertion tube from the patient, and ensuring that the device is securely in place.

[0014] In yet another embodiment, a method of removing an intrauterine adhesion barrier device from a patient is disclosed. The method includes providing an intrauterine adhesion barrier device having a frame with a vertical member and a horizontal member, and at least one flexible member attached to the vertical member and to the horizontal member. The vertical member has a first end and a second end, and the horizontal member has a first end, a second end, and a middle portion. The first end of the vertical member extends from the middle portion of the horizontal member, and the first end and the second end of the horizontal member extend outwardly from the vertical member. The method further includes applying a downward force to the vertical member, thereby causing the horizontal member to fold upwardly.

[0015] In another embodiment, a kit including the intrauterine adhesion barrier (IUAB) device described above is disclosed. The kit is enclosed in sterile packaging, and also includes an insertion tube with an internal diameter equal to or larger than that of an external diameter of the IUAB device, and instructions for insertion of the IUAB device into the uterus of a patient. The IUAB device is positioned within the insertion tube.

[0016] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Exemplary embodiments are illustrated in the drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

[0018] Figure 1A is a front view of an intrauterine adhesion barrier device of the present application including a retrieval element;

[0019] Figure IB is a front view of another embodiment of an intrauterine adhesion barrier device of the present application including a retrieval element;

[0020] Figure 2A is the intrauterine adhesion barrier device shown in Figure 1A without the retrieval element;

[0021] Figure 2B shows the intrauterine adhesion barrier device with arms folded upward;

[0022] Figure 2C shows the intrauterine adhesion barrier device with arms folded downward;

[0023] Figure 3A is the intrauterine adhesion barrier device shown in Figure IB without the retrieval element;

[0024] Figure 3B shows the intrauterine adhesion barrier device of Figure 3A with arms folded upward;

[0025] Figure 4 shows the intrauterine adhesion barrier device of Figure 1A inserted in a proper uterine position; [0026] Figure 5 shows the intrauterine adhesion barrier device of Figure 1A being removed from a uterus with arms folded upward attached to material; and

[0027] Figure 6 shows the intrauterine adhesion barrier device of Figure 1A being removed from a uterus with arms folded upward detached from material.

DETAILED DESCRIPTION

[0028] An intrauterine adhesion barrier (IUAB) device that aids in the prevention of adhesion reformation in a patient is disclosed. The IUAB device is easy to insert and remove, minimizes uterine cramping, minimizes the risk of being expelled, and minimizes the risk of ascending uterine infection. In some embodiments, the device comprises a T-shaped frame that supports one large or two smaller triangle shaped pieces of impervious flexible adhesion preventing material, and that prevents contact of the anterior and posterior walls of the uterine cavity during healing. The IUAB device may be inserted into a patient's uterus in its folded state using an insertion tube similar to, but of slightly greater diameter than that used for contemporary IUD insertion. The IUAD has a flat profile which minimizes uterine cramping and the risk of being expelled. Moreover, the risk of ascending uterine infection is minimized by the utilization of a retrieval means, such as a monofilament string, instead of a thick stem. Removal is relatively easily and painless because the arms of the frame extend and fold with traction.

[0029] Figures 1A and IB show an example IUAB device 100 of the present application. The IUAB device 100 includes a frame 102, which may have a T-shape. The frame 102 has a first, vertical member 104 and a second, horizontal member 110. The vertical and horizontal members 104, 110 may be constructed of a soft, flexible plastic material, for example. It should be understood that other suitable materials may be used as well. In one embodiment, the vertical member 104 and horizontal member 110 are constructed as a single piece. In an alternate embodiment, the vertical member 104 and horizontal member 110 may be constructed as two separate pieces which are connected together by a thread, for example. In other embodiments, the vertical and horizontal members may be connected together by any suitable fastening device.

[0030] The vertical member 104 has a first end 106 located adjacent the horizontal member 110, and a second end 108 located opposite the first end 106. The horizontal member 110 includes a first end 112, a second end 114 which is opposite the first end, and a middle portion 116 located between the first end 112 and the second end 114. The first end 106 of the vertical member 104 extends from the horizontal member 110 at the middle portion 116. Additionally, the first end 112 and the second end 114 of the horizontal member 110 extend outwardly from the vertical member 104.

[0031] As shown in Figure 1A, the IUAB device 100 further comprises one or two flexible members 130, 132 attached to both the vertical member 104 and to the horizontal member 110. The flexible members 130, 132 may comprise any shape such that when inserted into the uterus, the IUAB device 100 is of a sufficient size to prevent contact of the anterior and posterior walls of the uterine cavity. In some embodiments, the flexible members 130, 132 comprise triangle-shaped pieces of a flexible material. In an alternative embodiment, shown in Figure IB, a single flexible member 131, which may be a triangle- shaped flexible material, is connected to the frame 102. In other embodiments, the flexible materia] may take alternate shapes.

[0032] The flexible material may comprise, for example, an inert flexible material that does not adhere to healing human tissue, and thus acts as an adhesion barrier, such as expanded polytetrafluoroethylene material. In alternate embodiments, the flexible material may comprise other similar suitable materials as well.

[0033] Referring again to Figure 1A, the flexible members 130, 132 are attached to the IUAB device 100 via at least two respective attachment points, the first attachment point 134 positioned on the vertical member 104 and the second attachment point 136 positioned on the horizontal member 110. In some embodiments, the flexible members 130, 132 are attached to the frame 102 at three respective attachment points. In an example embodiment, the first attachment point 134 is at the first end 106 of the vertical member 104, the second attachment point 136 is at one end of the horizontal member 110, and the third attachment point 138 is at the second end 108 of the vertical member 104. In another embodiment, the second flexible member 132 is attached to the horizontal member 110 by an additional fourth attachment point 140. In other embodiments, alternate attachment configurations are possible.

[0034] In the case where a single flexible member 131 is used, the flexible member 131 may be attached to the horizontal member 110 at two attachment points 142, 144, as shown in Figure IB. In one embodiment, two layers of flexible material can be secured together around the vertical member 104 to create openings. Alternatively, the flexible member 131 may be securely attached to the vertical member 104 via a suitable fastening mechanism.

[0035] The flexible members 130, 132, or 131, may be firmly affixed to the IUAB frame 102 so that they do not become completely detached from the frame 102 during insertion or removal of the IUAB device 100 from the uterus. In some embodiments, the flexible members 130, 132, or 131 may be attached to the vertical and/or horizontal members 104, 110 by one or more of threads, staples, sleeves, or an adhesive, such as glue, or a combination thereof. In the case where only one flexible member 131 is used, two layers of flexible material can be secured together around the vertical member using adhesive, staples, or thread, for example.

[0036] In one embodiment, the flexible members 130, 132, or 131 may be attached to the horizontal member 110 using a structure that is intended to break when pulled into tension, such as a pop-off mechanism, fine thread or suture, an adhesive, or other similar structure. This type of structure will detach or break when a force is applied that folds the horizontal member 110 upwardly past perpendicular. In this embodiment, the flexible members 130, 132, or 131 will be firmly affixed to the vertical member 104 in such a manner that will not detach, thereby ensuring that the flexible members 130, 132, or 131 do not become completely detached from the frame 102.

[0037] The IUAB device 100 may further include a retrieval element 150 attached to the second end 108 of the vertical member 104. In some embodiments, the retrieval element 150 comprises a string, such as a monofilament string made of a durable material such as polyethylene or isotactic polypropylene, for example. It should be understood that other suitable retrieval elements and materials may be used as well. The retrieval element 150 facilitates removal of the IUAB device 100 from the uterus, which is described in more detail below.

[0038] Referring now to Figures 2A-2C, the IUAB device 100 is adapted to be folded in order to fit inside an insertion tube 200 for deliver)' to a patient. In one embodiment, the IUAB device 100 folds at one or more hinge points on the horizontal member 110 of the IUAB frame 102. In one example, the horizontal member 110 folds at two hinge points 118, 120. The first hinge point 118 is positioned between the first end 112 of the horizontal member 110 and the middle portion 116, and the second hinge point 120 is positioned between the second end 114 of the horizontal member 110 and the middle portion 116. When folded, the horizontal member 110 is divided into a first arm 111 and a second arm 113. The first arm 111 extends from the first end 112 of the horizontal member 110 to the first hinge point 118, and the second arm 113 extends from the second end 114 of the horizontal member 110 and the second hinge point 120. [0039] The arms 111, 113 of the IUAB device 100 may also fold during removal in order to allow for the device to slide through the cervix and out of the patient. For example, in one embodiment, the flexible material is firmly affixed to the horizontal member 110 with a breakable component (e.g., a thread) that remains attached when the arms 111, 113 are flexed downward for insertion, but breaks during removal when the arms 111, 113 are flexed upward. In an alternate embodiment, the connection between the flexible material and the horizontal member 110 may be in the form of one or more sleeves that slide along the horizontal member so that the flexible material can stay attached when the arms 111, 113 are flexed either upwards or downward for insertion and upward for removal. The insertion and removal of the IUAB device 100 is described in more detail below.

[0040] Figure 2B shows the IUAB device 100 with the flexible material 130, 132 folded upwardly. In this embodiment, the flexible material of the flexible members 130, 132 is folded upwardly by sliding or moving the third attachment 138, which may be in the form of a sleeve, upward on the vertical member 104. Figure 2C shows the IUAB device 100 with the flexible material of the flexible members 130, 132 folded downwardly. In this embodiment, the flexible material of the flexible members 130, 132 is folded downwardly by the first and fourth attachment points 136, 140, which may also be in the form of sleeves, sliding or moving along the horizontal member 110.

[0041] Similarly, in the case where only one flexible member 131 is used, the flexible material of the flexible member 131 folds as the two attachment points 142, 144 slide along the horizontal member 110, as shown in Figures 3 A and 3B. In one example, the flexible member 131 can comprise two layers of flexible material secured together around the vertical member 104 to create openings, allowing the connections or attachment points 142, 144 to slide along the horizontal member 110 when the frame folds upward, as shown in Figure 3B. It should be understood that the single flexible member 131 may fold downward as well, in a similar manner as described above with respect to Figure 2C.

[0042] When folded, the IUAB device 100 will fit into an insertion tube 200, as shown in Figures 2B, 2C, and 3B, similar to that used for IUD insertion, but of a slightly larger diameter to accommodate the bulk of the flexible members 130, 132. The insertion tube 200 facilitates insertion of the IUAB device 100 into a patient. When folded, the diameter of the IUAB device 100 measures in the range of about 5 mm to about 7 mm. Thus, the diameter of the insertion tube 200 may be in the range of about 7 mm to about 9 mm, for example.

[0043] Another aspect of the present disclosure provides a kit including the intrauterine adhesion barrier device 100. The kit may include, under sterile packaging, an inserter made up of a tube, such as tube 200 described above, having an internal diameter equal to or slightly larger than the external diameter of the intrauterine adhesion barrier (IUAB) device 100 described above. The kit further includes the IUAB device 100 positioned within the tube 200, and instructions for inserting the IUAB device 100 into the uterus of a patient.

[0044] In operation, the IUAB device 100 may be prepared for insertion into a patient by being collapsed into a folded state. The IUAB device 100 may be folded by pulling downward on the retrieval element 150, allowing the arms 111,113 of the horizontal member 110 to fold upwardly, as described above. In one embodiment, the IUAB device 100 is then placed into an inserter such as insertion tube 200. In some embodiments, the cervix of the patient is dilated prior to inserting the tube 200. For example, the cervix of the patient may be dilated to accommodate an operative hysteroscope with a diameter of about 5.5mm to about 8mm. The tube 200 containing the IUAB device 100 is then inserted into the uterus of the patient through the vagina. The tube 200 is placed at the mouth of the cervix, and the IUAB device 100 is then pushed through the tube 200 to fully insert the IUAB device 100 into the uterus of the patient. The IUAB device 100 is considered to be securely in place within the uterus when the arms 111, 113 fully extend so that they are perpendicular to the horizontal member 110, resulting in the triangle configuration. In one embodiment, the IUAB device is inserted into the uterus immediately following hysteroscopic lysis of adhesions to prevent adhesion reformation.

[0045] Referring to Figure 4, once inserted into the uterus 300, the tube 200 is removed from the patient, which causes the folded arms 111, 113 of the horizontal member 110 to expand outwardly about 90 degrees from the vertical member 104, and spread out the flexible members 130, 132. The retrieval element 150 may extend downwardly from the vertical member 104 into the vagina. Due to the substantially flat configuration of the IUAB device 100, there is minimal distention of the uterus.

[0046] To remove the IUAB device 100, the arms 111, 113 of the horizontal member 110 are once again folded by pulling downwardly on the retrieval element 150, as shown in Figure 5. In this embodiment, the flexible material of the flexible members 130, 132 slides at the third attachment 138 to the vertical member 104, and folds upwardly with the arms 111,113 when the IUAB device 100 is pulled into the tubular uterine cervix. The third attachment 138 may therefore be in the form of a sleeve.

[0047] Figure 6 shows an alternative embodiment of the folding of the IUAB device 100 for removal. In this embodiment, the arms 111, 113 of the horizontal member 110 are folded by pulling downwardly on the retrieval element 150 as in Figure 5. The downward force bends the arms 111, 113 upwardly past perpendicular, which causes the attachments 136, 140 to break, and therefore fully detach from the horizontal member 110. As mentioned above, the attachments 136, 140 may be any type of known mechanism, such as a pop-off mechanism, a fine suture or thread, or an adhesive, for example. The attachments 134, 138 to the vertical member 104 remain, and the IUAB device 100 can be fully removed from the patient. Example

[0048] In one embodiment, the IUAB device 100 may be inserted into the uterus immediately following hysteroscopic lysis of adhesions to prevent adhesion reformation. Because of the generally flat profile of the IUAB device 100, placement of the device does not result in uterine distension. Further, a thick stem does not protrude into the vagina.

[0049] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize that still further modifications, permutations, additions and sub-combinations thereof of the features of the disclosed embodiments are still possible. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and subcombinations as are within their true spirit and scope.