Abstract:
Disclosed are devices and methods for loading an intrauterine device (IUD) with a thread or suture engaged therewith into an insertion device. The devices and methods are suitable for use with an automated knot typing system.

Description:
CROSS-REFERENCE 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62/198,961, filed Jul. 30, 2015, entitled  Loading Device for IUDs and Insertion Devices  which application is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    An intrauterine device (IUD) is an object that, when placed in the uterus of a female, acts as a birth control device to prevent pregnancy. Two types of IUDs are commonly available, copper-containing devices and hormone-containing devices that release a progestogen. Hormonal containing devices are considered to be a different form of birth control and may be distinguished in the literature by the term intrauterine system (IUS). 
         [0003]    IUDs are typically inserted into the uterus using an insertion device or instrument. See, for example, U.S. Pat. No. 3,783,861 to Abramson for Inserter for Intrauterine Devices issued Jan. 8, 1974; U.S. Pat. No. 3,794,025 to Lerner for Intrauterine Device Saddle Inserter issued Feb. 26, 1974; U.S. Pat. No. 4,920,727 to Ristimaki et al. for Cassette System and Apparatus for Manufacturing an Active Agent Liberating Capsule for Subcutnaeous Use issued May 1, 1990; U.S. Pat. No. 4,949,732 to Spoon et al. for Apparatus for Insertion and Fixation of an Intra Uterine Contraceptive Device to the Uterine Fundus issued Aug. 21, 1990; U.S. Pat. No. 5,084,004 to Ranoux for Process for Intra-Uterine Fertilization in Mammals and Device for Implementation Thereof issued Jan. 28, 1992; U.S. Pat. No. 5,370,129 to Diaz et al. for IUD Inserting Apparatus issued Dec. 6, 1994; U.S. Pat. No. 5,400,804 to Helle et al. for Method and Equipment for Installing a Medicine Capsule on a Support issued Mar. 28, 1995; U.S. Pat. No. 5,785,053 to Macandrew et al. for Inserter for the Positioning of an Intrauterine Device issued Jul. 28, 1998; and US 2013/0014762 A1 to Deckman et al. for Intrauterine Systems, IUD Insertion Devices, and Related Methods and Kits Therefor published Jan. 17, 2013. 
         [0004]    During manufacturing of the system various challenges arise loading a threaded IUD into the distal end of the IUD insertion device such that the IUD is ready for deployment during use. 
       SUMMARY 
       [0005]    Disclosed are intrauterine device (IUD) insertion device loaders and methods for loading an IUD with a flexible member, such as a thread or suture engaged therewith, into an IUD insertion device. The deployed IUD insertion device loaders and methods are suitable for use with an automated knot tying system. 
         [0006]    An aspect of the disclosure is directed to an IUD loading device. Suitable IUD loading devices comprise: an elongated planar base having an upper surface and a lower surface; a linear slider engaging the upper surface of the planar base; a support plate secured to a portion of the linear slider; an IUD retainer; a clamp having a linear aperture therethrough and having a first clamp end and a second clamp end wherein the linear aperture at the first clamp end has a first diameter which tapers to a second aperture diameter central to the first clamp end and further wherein the linear aperture at the second clamp end has a first diameter which tapers to a second aperture diameter central to the second clamp end; and an inserter device retainer. Additionally, operation of the device can be controlled by pneumatic controls. Additionally, a vacuum applicator, such as a vacuum pump or venturi pump, can be provided in at least some configurations. The clamp may have a bivalve configuration that is openable about a hinge. Additionally, the insertion device retainer can include a hypotube. Additionally, the IUD retainer can comprise a channel for one or more flexible members of the IUD. 
         [0007]    Another aspect of the disclosure is directed to an IUD loading device comprising: an elongated planar base having an upper surface and a lower surface; an IUD retainer; a clamp having a linear aperture therethrough and having a first clamp end and a second clamp end wherein the linear aperture at the first clamp end has a first diameter which tapers to a second aperture diameter central to the first clamp end and further wherein the linear aperture at the second clamp end has a first diameter which tapers to a second aperture diameter central to the second clamp end; an inserter retainer; and pneumatic controls configured to draw a flexible member of an IUD through the clamp and into an inserter. The clamp can be openable about a hinge. additionally, the insertion device retainer can be a hypotube. A channel can be provided for one or more flexible members of the IUD. Additionally a vacuum applicator, such as a vacuum pump or venturi pump, can be provided. 
         [0008]    Still another aspect of the disclosure is directed to a method of inserting an IUD into an IUD insertion device. Suitable methods comprise: placing an IUD in an IUD retainer of an IUD loading device; positioning the IUD in the IUD retainer of the IUD loading device adjacent a first aperture in a clamp; placing an IUD inserter in an IUD inserter retainer of an IUD loading device; positioning the IUD inserter retainer of the IUD loading device adjacent a second aperture in the clamp; and applying a vacuum on the IUD inserter retainer and drawing one or more flexible members of the IUD into an aperture in the IUD insertion device. The methods can also include passing a hypotube through the IUD insertion device and/or feeding the flexible members of the IUD into the first aperture of the clamp. 
         [0009]    Yet another aspect of the disclosure is directed to an IUD loading device means. Suitable IUD loading device means comprise: an elongated planar base having an upper surface and a lower surface; a linear slider means engaging the upper surface of the planar base; a support plate secured to a portion of the linear slider; an IUD retainer means; a clamp means having a linear aperture therethrough and having a first clamp end and a second clamp end wherein the linear aperture at the first clamp end has a first diameter which tapers to a second aperture diameter central to the first clamp end and further wherein the linear aperture at the second clamp end has a first diameter which tapers to a second aperture diameter central to the second clamp end; and an insertion device retainer means. Additionally, a pneumatic control or pneumatic control means can be provided. In at least some configurations a vacuum pump or vacuum pump means (e.g. venturi pump) is also provided. Additionally, the clamp means can be configurable to be openable about a hinge. The insertion device retainer means can be a hypotube. Additionally, the IUD retainer means can comprise a channel for one or more flexible members of the IUD. 
         [0010]    Another aspect of the disclosure is directed to a method of inserting an IUD into an IUD insertion device comprising: placing an IUD in an IUD retainer means of an IUD loading device means; positioning the IUD in the IUD retainer means of the IUD loading device means adjacent a first aperture in a clamp; placing an IUD inserter in an inserter retainer means of an IUD loading device means; positioning the IUD inserter retainer means of the IUD loading device adjacent a second aperture in the clamp; and applying a vacuum on the IUD inserter retainer means and drawing one or more flexible members of the IUD into an aperture in the insertion device. Additionally, the method can include passing a hypotube through the IUD insertion device and/or feeding the flexible members of the IUD into the first aperture of the clamp. 
         [0011]    Still another aspect of the disclosure is directed to an IUD loading device comprising: an elongated planar base means having an upper surface and a lower surface; an IUD retainer means; a clamp means having a linear aperture therethrough and having a first clamp end and a second clamp end wherein the linear aperture at the first clamp end has a first diameter which tapers to a second aperture diameter central to the first clamp end and further wherein the linear aperture at the second clamp end has a first diameter which tapers to a second aperture diameter central to the second clamp end; an inserter retainer means; and pneumatic control means configured to draw a flexible member of an IUD through the clamp means and into an inserter means. The clamp means can be openable about a hinge means. Additionally, the insertion device retainer means can be a hypotube. A channel can be provided for one or more flexible members of the IUD. Additionally a vacuum applicator means can be provided. 
       INCORPORATION BY REFERENCE 
       [0012]    All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: 
           [0014]      FIGS. 1A-D  illustrate an IUD, an IUD positioned within the distal end of an IUD insertion device prior to deployment; an exemplar IUD insertion device, and a packaged IUD and IUD insertion device; 
           [0015]      FIGS. 2A-C  is an exploded view of a IUD insertion device loader for use associating an IUD with an IUD insertion device; a close-up of the hinged member; and a perspective view of the IUD insertion device loader in an assembled form; and 
           [0016]      FIGS. 3A-G  illustrate the steps of using the IUD insertion device loader. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]      FIGS. 1A-D  illustrates a T-frame intrauterine device (IUD), having an eyelet (aperture) at one end through which a flexible member, such as a thread or suture, is secured. A conventional T-shaped IUD  102 , is illustrated in  FIG. 1A . IUDs typically have a length of from about 31.5 mm to about 32.5 mm and a width of from about 31.5 mm to about 32.5 mm when the IUD is in the fully deployed position. As will be appreciated by those skilled in the art, the length does not include the knot or strings that may accompany the IUD. The T-shaped IUD comprises an elongated body  104  having a proximal end  10  and a distal end  20 . The elongated body  104  can include a time-release drug such as a hormone. In some configurations, the time-release drug can be provided as a coating or covering. The elongated body can be formed from any suitable material, including, but not limited to plastic or metal alloy. At the distal end  20  of the IUD (i.e., the end positioned away from the physician&#39;s hand), IUD arms  106   a,    106   b  are attached to or integrally formed with the elongated body  104 . The IUD arms  106   a,    106   b  are configurable to fold upward u or downward d to minimize the IUD cross-section such that the IUD can fit into an insertion device sheath or tube for insertion through the cervix and into the uterus during deployment. Additionally, either or both of the IUD arms  106   a,    106   b  are configurable to include an enlarged or bulbous tip  108   a,    108   b,  which can, for example, have a curved, spherical or semi-spherical shape. The bulbous tips  108   a,    108   b  of the IUD arms  106   a,    106   b  can be formed such that the IUD arms  106   a,    106   b,  when folded upward and pushed together, form a smooth and rounded distal tip. At the proximal end  10  of the IUD  102 , the IUD  102  can further include one or more flexible members  110   a,    110   b,  such as strings, attached to the IUD  102 . The flexible members  110   a,    110   b  are connectable to the IUD  102  at a connection point  111  which can be an aperture or eyelet in the elongated body  104  at the proximal end  10 , e.g., tied in a knot as illustrated. 
         [0018]    For purposes of providing perspective to the various components of the loading device and the IUD and IUD insertion device, the relative terms of proximal and distal have been used where proximal refers to the end closest to the user and distal refers to the end further away from the user. Thus it is convenient to describe the loading device in a way which references the positioning of the proximal and distal ends of the IUD and the IUD insertion device. These references are provided for convenience of disclosure and are not meant to be limiting. 
         [0019]      FIG. 1B  is a cross-section of an insertion device (such as the insertion device shown in  FIG. 1C ). As can be seen in this illustration when the IUD  102  is positioned at the distal tip or the elongated sheath  132  of the IUD insertion device  100  prior to deployment, the distal  20  tip has an aperture  131  with a diameter d 1  that is smaller than the diameter d 3  of the IUD  102 . The aperture of the IUD insertion device  100  has a diameter d 1  that is smaller than the diameter d 2  of the sheath of the IUD insertion device  100 . The IUD  102  is rotatable r in-plane about longitudinal axis x, such that the IUD arms  106   a,    106   b  or similar features of the IUD  102  will deploy in-line with respective openings of the patient&#39;s fallopian tubes. 
         [0020]    An exemplar IUD insertion device  100  is illustrated in  FIG. 1C . The IUD insertion device  100  is configurable to comprise a first cavity  145   a  and a second cavity  145   b  in the handle  135 . During step  3  of the insertion procedure, the sheath slider  142  and string control slider  146  are in the full proximal  10  position along the longitudinal axis of the elongated guide, and at least partially surrounded by the second cavity  145   b  which is proximal to the first cavity  145   a.  Additional visual indication features  160 ,  160 ′,  160 ″ are shown. Visual indication features can be provided on the elongated sheath  143 , the handle  135 , or both. The numbers 1, 2, and 3 on the insertion device components provide a visual indication to the user the appropriate positions of the insertion device components during the multiple phases of the insertion procedure. Visual indicators, such as numbers, can be applied in any suitable fashion including, but not limited to, printing, etching, molding, stamping, and the like. Moreover, visual indicators can be positioned such that they are visible only during certain aspects of the procedure, and not visible during other aspects of the procedure. 
         [0021]      FIG. 1D  illustrates an IUD partially positioned within the distal end of an IUD deployment device within packaging  190 . The IUD arms  106   a,    106   b  extend beyond the distal end of the IUD deployment device  100 . 
         [0022]      FIG. 2A  is an exploded view of an IUD insertion device loader  200 . The IUD insertion device loader  200  has an elongated planar base  210  which supports a linear slider  212 . A support plate  214  can also be provided which engages the linear slider  212 . An insertion device retainer  230  is provided and is configurable to engage the insertion device (such as the IUD insertion device  100  shown in  FIG. 1C ) during the loading process. An IUD retainer  220  is positioned in-line with the insertion device retainer  230  and positioned above the support plate  214 . A clamp  250  is positioned between the IUD retainer  220  and the insertion device retainer  230 . Pneumatic controls  270  can be provided at one end of the assembly to apply a vacuum, for example on an end of the assembly having the insertion device retainer  230 . The vacuum can be applied by any suitable vacuum applicator, such as a vacuum pump or venturi pump. The pneumatic controls can include pneumatically controlled valves that control the flow of pressurized air. Suitable valves include, for example, needle valves. The support plate  214  can engage the linear slider  212  and elongated planar base  210  by any suitable mechanism including, for example, the use of screws, bolts, washers, nuts, adhesive materials, or any other suitable material or device. 
         [0023]      FIG. 2B  is a close-up of the clamp  250  in an open configuration which, when closed, has an aperture therethrough forming a channel  252  formed in one or both the surfaces of the interior surfaces  254 ,  254 ′ of the clamp  250 . In one configuration, the clamp  250  is a bivalve having two similar parts hinged together. The two parts or plates  256 ,  256 ′ of the clamp  250  open and close about a hinge  258 . When the clamp  250  is closed an aperture extends linearly from a first end to a second end. The aperture has a first recess  260  on the first end, followed by a central tubular portion  260 ′ forming an interior portion of the aperture, and then a second recess  260 ″ on the second end. As illustrated the first and second recesses are shaped to define a conical aperture where the widest portion of the aperture is adjacent the exterior surface of the clamp  250 , and the narrowest portion is adjacent the central tubular portion  260 ′. As will be appreciated by those skilled in the art, other shapes could be used without departing from the scope of the disclosure. During use, the clamp  250  can be secured in a closed position using any suitable mechanism, including, but not limited to the use of magnetic material, suitable clasps or pins. 
         [0024]      FIG. 2C  illustrates the IUD insertion device loader  200  shown in  FIG. 2A  in an assembled configuration. 
         [0025]      FIGS. 3A-G  illustrate the steps of using the IUD insertion device loader  200  shown in  FIG. 2 . The IUD insertion device  100  is placed on the insertion device retainer  230 . A hypotube  280  of the IUD insertion device loader  200  is inserted into a proximal aperture  148  of IUD insertion device  100 . A suitable hypotube  280  is a small radiused tube which can, for example, be made from stainless steel. The hypotube  280 , passes through a central aperture of the IUD insertion device  100  from the proximal end  10  until it exits a distal end  20  of the IUD insertion device  100 . The end of the hypotube  280  extending out of the distal end of the IUD insertion device  100  is placed within the central channel  260 ′ formed in the clamp  250  while the clamp  250  is in an open position (shown in  FIG. 2B ). The distal end  20  of the IUD insertion device  100  is positioned within the first recess  260  which is a conical aperture formed at the insertion device receiving end of the clamp  250 . The positioning of the IUD insertion device  100  is such that the distal end  20  of the IUD insertion device  100  is not pinched by the clamp  250  when the clamp  250  is in a closed positon (shown in  FIG. 3F ), or otherwise engaged by the clamp  250  to cause deformation of the distal end  20  of the IUD insertion device  100 . The IUD  102  is placed within the IUD retainer  220  so that the flexible members  110   a,    110   b,  or strings, are positioned near the IUD receiving conical opening  252 ″ of the clamp  250 . The end of the strings or flexible members  110   a,    110   b  are positioned near enough the IUD receiving conical recess  252 ″ of the clamp  250  so that when the vacuum is applied by the vacuum applicator to the hypotube passing through the IUD insertion device  100  into the clamp  250 , the strings or flexible members  110   a,    110   b  are placed a centimeter or two inside the inner channel  252 ′ of the clamp/hypotube and then the vacuum draws the flexible members  110   a,    110   b  through the remainder of the IUD insertion device. 
         [0026]    Thereafter, the clamp  250  is opened, and the IUD  102  is drawn into a final position within the IUD insertion device  100  so that the IUD  102  and IUD insertion device  100  are ready to be packaged and shipped as shown in  FIG. 1D . 
         [0027]    Once the IUD is positioned within the IUD inserter device, the device can be packaged, sterilized and shipped. 
         [0028]    While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.