Patent Description:
IUDs are typically inserted into the uterus using an insertion device or instrument. See, for example, <CIT>;<CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; and <CIT>.

<CIT> which is the closest prior art document for the present invention, discloses an intrauterine system including an intrauterine device (IUD), an insertion device or applicator for inserting the IUD into the cervix of a female patient.

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.

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.

An aspect of the invention is directed to a loading device according to claim <NUM>. 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.

Another aspect of the invention is directed to a loading device according to claim <NUM>. 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.

Still another aspect of the invention is directed to a method of inserting an IUD into an IUD insertion device according to claim <NUM>. 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.

<FIG>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 <NUM>, is illustrated in <FIG>. IUDs typically have a length of from about <NUM> to about <NUM> and a width of from about <NUM> to about <NUM> 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 <NUM> having a proximal end <NUM> and a distal end <NUM>. The elongated body <NUM> 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 <NUM> of the IUD (i.e., the end positioned away from the physician's hand), IUD arms 106a, 106b are attached to or integrally formed with the elongated body <NUM>. The IUD arms 106a, 106b 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 106a, 106b are configurable to include an enlarged or bulbous tip 108a, 108b, which can, for example, have a curved, spherical or semi-spherical shape. The bulbous tips 108a, 108b of the IUD arms 106a, 106b can be formed such that the IUD arms 106a, 106b, when folded upward and pushed together, form a smooth and rounded distal tip. At the proximal end <NUM> of the IUD <NUM>, the IUD <NUM> can further include one or more flexible members 110a, 110b, such as strings, attached to the IUD <NUM>. The flexible members 110a, 110b are connectable to the IUD <NUM> at a connection point <NUM> which can be an aperture or eyelet in the elongated body <NUM> at the proximal end <NUM>, e.g., tied in a knot as illustrated.

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.

<FIG> is a cross-section of an insertion device (such as the insertion device shown in <FIG>). As can be seen in this illustration when the IUD <NUM> is positioned at the distal tip or the elongated sheath <NUM> of the IUD insertion device <NUM> prior to deployment, the distal <NUM> tip has an aperture <NUM> with a diameter d1 that is smaller than the diameter d3 of the IUD <NUM>. The aperture of the IUD insertion device <NUM> has a diameter d1 that is smaller than the diameter d2 of the sheath of the IUD insertion device <NUM>. The IUD <NUM> is rotatable r in-plane about longitudinal axis x, such that the IUD arms 106a, 106b or similar features of the IUD <NUM> will deploy in-line with respective openings of the patient's fallopian tubes.

An exemplar IUD insertion device <NUM> is illustrated in <FIG>. The IUD insertion device <NUM> is configurable to comprise a first cavity 145a and a second cavity 145b in the handle <NUM>. During step <NUM> of the insertion procedure, the sheath slider <NUM> and string control slider <NUM> are in the full proximal <NUM> position along the longitudinal axis of the elongated guide, and at least partially surrounded by the second cavity 145b which is proximal to the first cavity 145a. Additional visual indication features <NUM>, <NUM>', <NUM>" are shown. Visual indication features can be provided on the elongated sheath <NUM>, the handle <NUM>, or both. The numbers <NUM>, <NUM>, and <NUM> 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.

<FIG> illustrates an IUD partially positioned within the distal end of an IUD deployment device within packaging <NUM>. The IUD arms 106a, 106b extend beyond the distal end of the IUD deployment device <NUM>.

<FIG> is an exploded view of an IUD insertion device loader <NUM>. The IUD insertion device loader <NUM> has an elongated planar base <NUM> which supports a linear slider <NUM>. A support plate <NUM> can also be provided which engages the linear slider <NUM>. An insertion device retainer <NUM> is provided and is configurable to engage the insertion device (such as the IUD insertion device <NUM> shown in <FIG>) during the loading process. An IUD retainer <NUM> is positioned in-line with the insertion device retainer <NUM> and positioned above the support plate <NUM>. A clamp <NUM> is positioned between the IUD retainer <NUM> and the insertion device retainer <NUM>. Pneumatic controls <NUM> 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 <NUM>. 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 <NUM> can engage the linear slider <NUM> and elongated planar base <NUM> by any suitable mechanism including, for example, the use of screws, bolts, washers, nuts, adhesive materials, or any other suitable material or device.

<FIG> is a close-up of the clamp <NUM> in an open configuration which, when closed, has an aperture therethrough forming a channel <NUM> formed in one or both the surfaces of the interior surfaces <NUM>, <NUM>' of the clamp <NUM>. In one configuration, the clamp <NUM> is a bivalve having two similar parts hinged together. The two parts or plates <NUM>, <NUM>' of the clamp <NUM> open and close about a hinge <NUM>. When the clamp <NUM> is closed an aperture extends linearly from a first end to a second end. The aperture has a first recess <NUM> on the first end, followed by a central tubular portion <NUM>' forming an interior portion of the aperture, and then a second recess <NUM>" 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 <NUM>, and the narrowest portion is adjacent the central tubular portion <NUM>'. 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 <NUM> 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.

<FIG> illustrates the IUD insertion device loader <NUM> shown in <FIG> in an assembled configuration.

<FIG>illustrate the steps of using the IUD insertion device loader <NUM> shown in <FIG>. The IUD insertion device <NUM> is placed on the insertion device retainer <NUM>. A hypotube <NUM> of the IUD insertion device loader <NUM> is inserted into a proximal aperture <NUM> of IUD insertion device <NUM>. A suitable hypotube <NUM> is a small radiused tube which can, for example, be made from stainless steel. The hypotube <NUM>, passes through a central aperture of the IUD insertion device <NUM> from the proximal end <NUM> until it exits a distal end <NUM> of the IUD insertion device <NUM>. The end of the hypotube <NUM> extending out of the distal end of the IUD insertion device <NUM> is placed within the central channel <NUM>' formed in the clamp <NUM> while the clamp <NUM> is in an open position (shown in <FIG>). The distal end <NUM> of the IUD insertion device <NUM> is positioned within the first recess <NUM> which is a conical aperture formed at the insertion device receiving end of the clamp <NUM>. The positioning of the IUD insertion device <NUM> is such that the distal end <NUM> of the IUD insertion device <NUM> is not pinched by the clamp <NUM> when the clamp <NUM> is in a closed positon (shown in <FIG>), or otherwise engaged by the clamp <NUM> to cause deformation of the distal end <NUM> of the IUD insertion device <NUM>. The IUD <NUM> is placed within the IUD retainer <NUM> so that the flexible members 110a, 110b, or strings, are positioned near the IUD receiving conical opening <NUM>" of the clamp <NUM>. The end of the strings or flexible members 110a, 110b are positioned near enough the IUD receiving conical recess <NUM>" of the clamp <NUM> so that when the vacuum is applied by the vacuum applicator to the hypotube passing through the IUD insertion device <NUM> into the clamp <NUM>, the strings or flexible members 110a, 110b are placed a centimeter or two inside the inner channel <NUM>' of the clamp/hypotube and then the vacuum draws the flexible members 110a, 110b through the remainder of the IUD insertion device.

Thereafter, the clamp <NUM> is opened, and the IUD <NUM> is drawn into a final position within the IUD insertion device <NUM> so that the IUD <NUM> and IUD insertion device <NUM> are ready to be packaged and shipped as shown in <FIG>.

Once the IUD is positioned within the IUD inserter device, the device can be packaged, sterilized and shipped.

Claim 1:
A loading device (<NUM>) for performing a loading process of loading an IUD (<NUM>) into an IUD insertion device (<NUM>), the loading device comprising:
an elongated planar base (<NUM>) having an upper surface and a lower surface;
a linear slider (<NUM>) engaging the upper surface of the planar base;
a support plate (<NUM>) secured to a portion of the linear slider;
an IUD retainer (<NUM>) into which an IUD may be placed;
a clamp (<NUM>) 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 IUD insertion device retainer (<NUM>) configured to releasably engage an IUD insertion device during a loading process.