IUD insertion devices

Single-handed IUD insertion devices, methods and kits are disclosed. The single-handed IUD insertion devices have a plurality of flexing detent arms to control axial movement of the 641 elongated guide and string control slider during use.

BACKGROUND

Field of the Invention

The disclosure relates to intrauterine systems (IUS), intrauterine devices (IUDs), insertion devices, methods of use, and kits therefor.

Background of the Invention

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).

Copper IUDs work by negatively affecting the mobility of sperm and preventing the sperm from joining an egg. Additionally, the foreign copper body positioned within the uterus also irritates the lining of the uterus and uterine wall making it difficult for an embryo to plant in the wall if the egg is fertilized by the sperm. IUS devices, such as the hormonal IUD Mirena® (marketed by Bayer) reduce or prevent menstrual bleeding. The Mirena® device releases levonorgestresl (a progestogen).

Conventional insertion devices used with IUDs (which includes devices used for IUSs) can cause pain and even loss of consciousness to a patient during the insertion procedure as a result of induction of a vagal reflex response.

As will be appreciated by those skilled in the art, a variety of shapes and sizes have been previously disclosed for IUD devices. Additionally, IUDs are typically inserted using an insertion device or instrument.

Thus, there exists a need for insertion devices adaptable and configurable for use with IUDs and related methods and kits which are easy-to-use, and operate smoothly for a healthcare practitioner using a single hand.

SUMMARY

Disclosed is an insertion device for use with an IUD. The insertion device has a handle and an elongated sheath. Two curved members forming cavities for a pair of sliders are positioned at a proximal end of the handle and a distal end of the handle. A sheath slider is positioned distally and is configurable to slide proximally within a portion of the distal cavity. When the sheath slider moves proximally, the sheath slider engages a string control slider. The sheath slider and the string control slider are configurable to engage and operate integrally when further proximal movement occurs. A small amount of force, e.g., from 0.25 to 0.75 lbs, more preferably from 0.5 to 0.75 lbs moves the sheath slider from an initial position to a second position. The small amount of force helps avoid or minimize incomplete insertions of an IUD by providing additional stability while the user loads the IUD and inserts the insertion device holding the IUD into a patient. The sheath slider is configurable so that it does not move past the string control slider. This ensures that the string control slider is moved all the way to the proximal position allowing the release of the strings of the IUD. The configuration of the insertion device eliminates the need for an inner sleeve at a distal position within the sheath. A hard stop feature is positioned within an interior of the handle assembly. Three pairs of detent features are positioned within the interior of the housing along the length of the housing. All three detent features have a plane of action oriented 90 degrees from a plane of ultrasonic welding of the handles. Positioning the detent features 90 degrees from the plane of the ultrasonic weld minimizes any influence of the ultrasonic welding process on a detent force value. The main slider will have additional tensile holding features to secure the tube and minimize the change of the tube dislodging from the main slider. Additional torsional holding features are also provided to secure the main tube to the handle to minimize the chance of the tube rotating within the main slider. Additional strengtheners are positioned inside the handle around the weld area to minimize the handle haves from separating during removal from the packaging. The sharp edge of the cleft has been rounded to minimize breakage of the IUD strings and the string control slider and string guide are molded into a single part.

An aspect of the disclosure is directed to insertion devices for inserting an IUD. Insertion devices comprise: an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, a rail along a side of the moveable sheath slider and a lateral detent arm, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises a hard stop and one or more string control slider detent arms in an interior of the user interface and a rib.

Another aspect of the disclosure is directed to methods of inserting an IUD into a uterus with an insertion device. Suitable methods comprise the steps of: providing the insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, a rail along a side of the moveable sheath slider and a lateral detent arm, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises a hard stop and one or more string control slider detent arms in an interior of the user interface and a rib; advancing the insertion device and the IUD into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing a radial diameter of the IUD; and releasing the IUD from the insertion device.

Still another aspect of the disclosure is directed to methods of hormonally treating a patient. Suitable methods comprise the steps of: providing an IUD which delivers an active agent; inserting the IUD with the active agent into a uterus of a patient with an insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, a rail along a side of the moveable sheath slider and a lateral detent arm, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises a hard stop and one or more string control slider detent arms in an interior of the user interface and a rib; advancing the insertion device and the IUD with the active agent into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD with the active agent distally; releasing the IUD with the active agent from the insertion device; and delivering the active agent from the IUD to the patient.

Another aspect of the disclosure is directed to insertion devices for inserting an IUD comprising: an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, a rail along a side of the moveable sheath slider and a lateral detent arm, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider. In some configurations, the proximally positioned user interface and the sheath slider further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the user interface is adapted and configured to mechanically complement the one or more alignment surfaces of the sheath. Additionally, a first sheath slider alignment surface can align with a first user interface alignment surface at a first position along a length of the elongated channel. The elongated channel can further comprise one or more cavities on one or more of a proximal end of the elongated channel and a distal end of the elongated channel wherein the one or more cavities are adapted and configured to house at least a portion of the movable sheath slider. The string control slider can be configured such that it is adaptable and configurable to securely move within the elongated channel. In at least some configurations, the moveable sheath slider and the string control slider are adapted and configured to operate at least one of simultaneously and independently within the elongated channel. The string slider can also be configured to partially surround and the sheath slider. The insertion device can be configurable to receive the IUD within a distal end of the lumen of the elongated sheath and wherein the insertion device further comprises at least one string locking feature adaptable and configurable to secure one or more string components of the IUD. Additionally, the distal end of the elongated sheath can have an atraumatic tip selected from the group comprising a rounded tip and a tapered tip. The moveable sheath slider can further comprise a second rail along a second side of the moveable sheath slider and a second lateral detent arm. Additionally, in at least some configurations, the moveable sheath slider further comprises a top half and a bottom half. The string control slider further can further comprise an interiorly positioned hard stop. The user interface can further comprise one or more string control slider detent arm in an interior of the user interface and a rib. In some configurations, the one or more string control slider detent arms flex inwardly and/or flex outwardly, i.e, towards a central axis or away from a central axis.

Still another aspect of the disclosure is directed to methods of inserting an IUD into a uterus with an insertion device comprising the steps of: providing the insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath, an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member, a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, a rail along a side of the moveable sheath slider and a lateral detent arm, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider; advancing the insertion device and the IUD into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing a radial diameter of the IUD; and releasing the IUD from the insertion device. The methods can further comprise the step of moving the string control slider within the elongated channel. Additionally, the step of moving the moveable sheath slider and the string control slider of the insertion device can occur simultaneously within the elongated channel. In some embodiments, the step of moving the moveable sheath slider and the string control slider of the insertion device independently within the elongated channel. The sheath slider and the string control slider of the insertion device can also be moved telescopically along at least a first portion of the elongated channel. The IUD can deliver an active agent once inserted. The active agent can be a hormone used for the treatment of menopausal troubles or for contraception.

Yet another aspect of the disclosure is directed to methods of hormonally treating a patient comprising the steps of: providing an IUD which delivers an active agent; inserting the IUD with the active agent into a uterus of a patient with an insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath, an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member, a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, a rail along a side of the moveable sheath slider and a lateral detent arm, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider; advancing the insertion device and the IUD with the active agent into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD with the active agent distally; releasing the IUD with the active agent from the insertion device; and delivering the active agent from the IUD to the patient. The active agent can be a hormone used for the treatment of menopausal troubles or for contraception.

Another aspect of the disclosure is directed to an insertion device for inserting an IUD comprising: an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises an interiorly positioned hard stop. The proximally positioned user interface and the sheath slider can further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the user interface is adapted and configured to mechanically complement the one or more alignment surfaces of the sheath. In some configurations, a first sheath slider alignment surface aligns with a first user interface alignment surface at a first position along a length of the elongated channel. The elongated channel further comprises one or more cavities on one or more of a proximal end of the elongated channel and a distal end of the elongated channel wherein the one or more cavities are adapted and configured to house at least a portion of the movable sheath slider. In some configurations, the string control slider is adaptable and configurable to securely move within the elongated channel. Additionally, the moveable sheath slider and the string control slider are adapted and configured in at least some configurations to operate at least one of simultaneously and independently within the elongated channel. The string slider can be configured to partially surround and the sheath slider in some configurations. The insertion device can be configurable to receive the IUD within a distal end of the lumen of the elongated sheath and further comprise at least one string locking feature adaptable and configurable to secure one or more string components of the IUD. The distal end of the elongated sheath can be configurable to have an atraumatic tip selected from the group comprising a rounded tip and a tapered tip. In some configurations, the moveable sheath slider further comprises a rail along a side of the moveable sheath slider and a lateral detent arm. The moveable sheath slider can further comprise a second rail along a second side of the moveable sheath slider and a second lateral detent arm. The moveable sheath slider can further comprise a top half and a bottom half in some configurations. Additionally, the user interface can further comprise one or more string control slider detent arm in an interior of the user interface and a rib. The one or more string control slider detent arms can also be configured to flex inwardly and/or flex outwardly.

Still another aspect of the disclosure is directed to methods of inserting an IUD into a uterus with an insertion device comprising the steps of: providing the insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises an interiorly positioned hard stop; advancing the insertion device and the IUD into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing a radial diameter of the IUD; and releasing the IUD from the insertion device. The methods can further comprise the step of moving the string control slider within the elongated channel. Additionally, the step of moving the moveable sheath slider and the string control slider of the insertion device can occur simultaneously within the elongated channel. In some embodiments, the step of moving the moveable sheath slider and the string control slider of the insertion device independently within the elongated channel. The sheath slider and the string control slider of the insertion device can also be moved telescopically along at least a first portion of the elongated channel. The IUD can deliver an active agent once inserted. The active agent can be a hormone used for the treatment of menopausal troubles or for contraception.

Another aspect of the disclosure is directed to methods of hormonally treating a patient comprising the steps of: providing an IUD which delivers an active agent; inserting the IUD with the active agent into a uterus of a patient with an insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises an interiorly positioned hard stop; advancing the insertion device and the IUD with the active agent into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD with the active agent distally; releasing the IUD with the active agent from the insertion device; and delivering the active agent from the IUD to the patient. The active agent can be a hormone used for the treatment of menopausal troubles or for contraception.

Another aspect of the disclosure is directed to insertion device for inserting an IUD comprising: an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises one or more string control slider detent arms in an interior of the user interface and a rib. The proximally positioned user interface and the sheath slider can further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the user interface is adapted and configured to mechanically complement the one or more alignment surfaces of the sheath. Additionally, a first sheath slider alignment surface can align with a first user interface alignment surface at a first position along a length of the elongated channel. The elongated channel can further comprise one or more cavities on one or more of a proximal end of the elongated channel and a distal end of the elongated channel wherein the one or more cavities are adapted and configured to house at least a portion of the movable sheath slider. The string control slider, in some configurations, is adaptable and configurable to securely move within the elongated channel. The moveable sheath slider and the string control slider are also adaptable and configurable to operate at least one of simultaneously and independently within the elongated channel. The string slider can also be configured to partially surrounds and the sheath slider. In some configurations, the insertion device is configurable to receive the IUD within a distal end of the lumen of the elongated sheath and wherein the insertion device further comprises at least one string locking feature adaptable and configurable to secure one or more string components of the IUD. The distal end of the elongated sheath can have an atraumatic tip selected from the group comprising a rounded tip and a tapered tip. Additionally, the moveable sheath slider can further comprise a second rail along a second side of the moveable sheath slider and a second lateral detent arm. In some configurations, the moveable sheath slider further comprises a top half and a bottom half. The moveable sheath slider further comprises a rail along a side of the moveable sheath slider and a lateral detent arm. The user interface can further comprise a hard stop. Additionally, one or more string control slider detent arms can flex inwardly and/or flex outwardly.

Still another aspect of the disclosure is directed to methods of inserting an IUD into a uterus with an insertion device comprising the steps of: providing the insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; and a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises one or more string control slider detent arms in an interior of the user interface and a rib; advancing the insertion device and the IUD into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing a radial diameter of the IUD; and releasing the IUD from the insertion device. The methods can further comprise the step of moving the string control slider within the elongated channel. Additionally, the step of moving the moveable sheath slider and the string control slider of the insertion device can occur simultaneously within the elongated channel. In some embodiments, the step of moving the moveable sheath slider and the string control slider of the insertion device independently within the elongated channel. The sheath slider and the string control slider of the insertion device can also be moved telescopically along at least a first portion of the elongated channel. The IUD can deliver an active agent once inserted. The active agent can be a hormone used for the treatment of menopausal troubles or for contraception.

Yet another aspect of the disclosure is directed to methods of hormonally treating a patient comprising the steps of: providing an IUD which delivers an active agent; inserting the IUD with the active agent into a uterus of a patient with an insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath; an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member; a proximally positioned user interface, wherein the proximally positioned user interface further comprises an elongated channel, a moveable sheath slider moveable within the elongated channel wherein the moveable sheath slider has an upper surface, a lower surface and two side surfaces, further wherein the moveable sheath slider has a depression on an upper surface of the moveable sheath slider facing an exterior of the user interface, and a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider wherein the string control slider further comprises one or more string control slider detent arms in an interior of the user interface and a rib; advancing the insertion device and the IUD with the active agent into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD with the active agent distally; releasing the IUD with the active agent from the insertion device; and delivering the active agent from the IUD to the patient. The active agent can be a hormone used for the treatment of menopausal troubles or for contraception.

INCORPORATION BY REFERENCE

U.S. Pat. No. 3,902,483 A to Place et al. for Intrauterine Device with Locator Means for Indicating Uterine Position of Device issued Sep. 2, 1975;

U.S. Pat. No. 4,372,302 A to Akerlund for Instrument for Retrieval of Retracted Threads of Intrauterine Contraceptive Devices issued Feb. 8, 1983;

U.S. Pat. No. 4,920,727 A 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 A 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 A to Ranoux for Process for Intra-Uterine Fertilization in Mammals and Device for Implementation Thereof issued Jan. 28, 1992;

U.S. Pat. No. 5,400,804 A 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 A to Macandrew et al. for Inserter for the Positioning of an Intrauterine Device issued Jul. 28, 1998;

U.S. Pat. No. 6,056,976 A to Markkula et al. for Elastomer, Its Preparation and Use issued May 2, 2000;

U.S. Pat. No. 6,063,395 A to Markkula et al. for Drug Delivery Device Especially for the Delivery of Progestins and Estrogens issued May 16, 2000;

U.S. Pat. No. 6,117,442 A to Markkula et al. for Drug Delivery Device, Especially for the Delivery of Androgens issued Sep. 12, 2000;

U.S. Pat. No. 7,862,552 B2 to McIntyre et al. for Medical Devices for Treating Urological and Uterine Conditions issued Jan. 4, 2011;

U.S. Patent Pub. US 2005/0045183 A1 to Callister et al. for Methods and Devices for Occluding Body Lumens and/or for Delivering Therapeutic Agents issued Mar. 3, 2005; and

U.S. Patent Pub. US 2008/0095825 A1 to LaFont for Method for Making a Reservoir Containing an Active Substance Diffused Through the Reservoir and Installation Therefor published Apr. 24, 2008.

DETAILED DESCRIPTION

One type of intrauterine insertion devices is a two-handed insertion device100or inserter such as the two-handed insertion device100shown inFIGS.1A-1C. The two-handed insertion device100includes a sheath132having a proximal end10and a distal end20and a lumen extending between the proximal end and the distal end for housing the IUD. A plunger134is provided for pushing and IUD through the sheath when deploying the IUD within a uterus of a patient. User interface, such as a handle135, is provided for holding the two-handed insertion device100. When in use, an operator (healthcare provider) holds the handle135of the two-handed insertion device shown inFIGS.1A-1Cin one hand and the sheath132with the other hand. When the insertion device is positioned within the uterus of a patient, the handle135is moved distally to push the IUD, which is positioned within the sheath132, out the distal end of the sheath132. Once the IUD is pushed out of the distal end of the sheath, the IUD is deployed within the uterus of the patient.

As will be discussed in more detail below, in contrast to two-handed insertion devices, such as depicted inFIG.1A-C, the insertion devices of the present disclosure are configured to house an IUD during the insertion procedure and is further configured to aid in positioning the IUD during the insertion procedure as well as advancing the IUD from the insertion device into a patient's uterus. The insertion devices are adaptable and configurable for insertion of a variety of IUDs configurations. Moreover, the insertion devices can be operated with a single hand. The insertion devices also provide tactile feedback to the user during the insertion steps.

The insertion devices can, for example, be used with a t-shaped IUD202, such as the IUD as shown inFIG.2. IUDs typically have a length of from about 31.90 mm to about 32.22 mm and a width of from about 31.81 mm to about 32.13 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 body204having a proximal end10and a distal end20. The elongated body204can include a coating such as a time-release drug or hormone. The elongated body204can be formed from any suitable material, including, but not limited to plastic or copper. At the distal end20of the IUD (i.e., the end positioned away from the physician's hand), IUD arms206a,206bare attached to or integrally formed with the elongated body204. The IUD arms206a,206bare 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. Additionally, either or both of the IUD arms206a,206bare configurable to include an enlarged or bulbous tips208a,208b, which can, for example, have a curved, spherical or semi-spherical shape. The bulbous tips208a,208bof the IUD arms206a,206bcan be formed such that the IUD arms, when folded upward and pushed together, form a smooth and rounded distal tip, for example, as shown inFIGS.3B-3Cand described below. At the proximal end of the t-shaped IUD202, the IUD can further include one or more strings210a,210battached to the IUD. The strings are connectable to the IUD at a connection point211, e.g., tied in a knot as illustrated.

Although the insertion devices are generally described herein with regard to a t-shaped IUD such as the IUD shown inFIG.2, it should be noted that the insertion devices of the present disclosure are adaptable to facilitate insertion of other IUD configurations, as would be appreciated by a person of skill in the art. Moreover, insertion device operation and IUD insertion procedures can include any number of steps corresponding to a desired IUD position. In addition to the features described below, the insertion devices of the present disclosure include IUD position control features which may be advantageous for insertion of IUDs having a variety of configurations. For example, while the IUD insertion procedure described below refers to a three-phase procedure corresponding to three different IUD positions, the insertion device operation procedure can include less than three or more than three steps. Accordingly, the insertion devices can include any number of position control features corresponding to the desired IUD positions. The insertion device of the present disclosure can be used with various conventional IUDs available on the market, including such devices as the T-frame LNg-20 IUD, marketed as Mirena® by Bayer®, as well as the Neo-Safe CuT 380A™ available from Mona-Lisa™.

Insertion devices disclosed herein are configurable to operate according to procedural steps which generally mimic commonly known and used procedures for IUD insertion. However, the insertion devices of the present disclosure include improvements in the structure and operation of the insertion devices. In another aspect of the disclosed insertion devices, procedural steps for IUD insertion include: (i) insertion device preparation procedures that occur pre-insertion, (ii) a first phase of IUD insertion (also referred to herein as phase 1, position 1, or step 1), (iii) a second phase of IUD insertion (also referred to herein as phase 2, position 2, or step 2), (iv) a third phase of IUD insertion (also referred to herein as phase 3, position 3, or step 3), and (v) post-insertion procedures. The positioning and operation of the insertion devices during the first phase through third phase are discussed in more detail below with respect toFIGS.17A-17C.

Insertion device preparation procedures that occur pre-insertion include, for example, loading a t-shaped IUD202, such as the IUD illustrated inFIG.2, into an insertion device, aligning the t-shaped IUD202in-plane with a patient, positioning the t-shaped IUD202in a correct longitudinal position along the length of a sheath of the insertion device, and locking the IUD into a position for insertion. As will be appreciated by those skilled in the art, loading the IUD into the insertion device can occur as part of Such insertion device preparation procedures are described in further detail below.

FIGS.3A-3Cillustrate positioning of the distal tip of an insertion device300during a first phase of IUD insertion according to an aspect of the present disclosure using a demonstrator333to represent patient anatomy. The demonstrator333has a cervical canal321area and a uterus314area.

InFIG.3A, the insertion device300is sized and configured for positioning within a uterus, having a tube length (or working length) of from 15 cm to 25 cm, and a diameter of 3 mm to about 5 mm. A distal end20of a sheath332, having a proximal end and a distal end and a sheath lumen extending between the proximal end and the distal end, is advanced through a cervical canal such that the sheath332protrudes slightly into the uterus (uterus314area of the demonstrator333). The t-shaped IUD202is not yet deployed and remains within the sheath332. The bulbous tips208a,208bof the t-shaped IUD202may be partially deployed to create a rounded shape at the distal end20of the insertion device300, as shown inFIG.3B, while the elongated body204of the t-shaped IUD202remains positioned within the elongated lumen of the sheath332Alternatively, in aspects where the sheath332of the insertion device300or other feature provides a rounded distal tip, the IUD arms206a,206bare encasable by the sheath332, as shown in the cross-section taken along the lines B-B inFIG.3Band shown inFIG.3C. In a first dimension, the diameter of the IUD when it is fully positioned within the sheath332will be smaller than a second, larger, diameter when the IUD is advanced distally beyond the tip of the sheath332so that the IUD arms206a,206bextend away from a central axis of the t-shaped IUD202. A reservoir220can be provided for containing an active agent.

FIG.3Dillustrates a view down the barrel of the device taken from the view D-D inFIG.3Bof the insertion device300, during a first phase of IUD insertion according to an aspect of the present disclosure. Aperture331has a diameter d1that is smaller than the diameter d2of the sheath332. The t-shaped IUD202is rotatable r in-plane about longitudinal axis x as shown inFIG.3D, such that the IUD arms206a,206b, or similar features of the IUD will deploy in-line with respective openings of the patient's fallopian tubes.

A contraceptive device, which is available on the market and which releases levonorgestrel, consists of a t-shaped IUD202having an elongated body204fabricated of polyethylene equipped with a reservoir220adjusted around the elongated body204and containing, for example, the hormone levonorgestrel. Thus, the IUD is configurable to comprise a core part around which a jacket-like polymeric reservoir containing an active agent has been fitted. The active agent includes hormones used for the treatment of menopausal troubles or for contraception. The IUD is sold in sterile packaging together with the inserter with the plunger contained within the protecting tube. The t-shaped IUD202can be positioned at the forward end of the plunger (distal end) with the hormone-containing elongate member protected by the sheath132. The IUD arms206a,206bof the transverse member, on the other hand, are expanded in order to prevent fatigue. The strings210a,210bby which the t-shaped IUD202is retracted towards the outside of a patient during removal (e.g., pulled proximally) run between the plunger134and the sheath132(e.g., protective tube) and end at the end of the handle135.

FIGS.4A-4Cdepict a cross-section of the t-shaped IUD202positioned in a distal end20of an insertion device400taken along the lines4-4ofFIG.3B. Initially, the t-shaped IUD202is fully positioned within the sheath432of the insertion device (FIG.4Aduring phase 1). Once the insertion device is positioned within the uterus, the t-shaped IUD202is advanced distally so that the IUD arms206a,206bbegin to exit the sheath432of the insertion device400(FIG.4Bduring phase 1).

Once the IUD is advanced distally the IUD arms206a,206bof the t-shaped IUD202extend radially away from a central axis x when the IUD arms206a,206bare clear of the distal end of the sheath during phase 2 of the insertion process.

FIGS.4D-4Eillustrate positioning of an insertion device400during phase 2 of the IUD insertion procedure using a demonstrator433to represent the patient anatomy. The t-shaped IUD202is partially deployed (similar toFIG.4C) such that the elongated body204of the t-shaped IUD202remains positioned within the sheath432, and the IUD arms206a,206bof the t-shaped IUD have been fully released from the sheath432and unfold to extend outward from the elongated body204of the t-shaped IUD202. As shown inFIG.4D, the insertion device400is extended distally into the uterus, represented by the demonstrator433, until a flange434reaches a set distance from an external orifice422of the cervix420, and the IUD is partially deployed from the sheath432of the insertion device400into the uterus. A clinician operating the insertion device400can, during use, maintain a position shown inFIG.4Dfor a period of time, e.g., 10-25 seconds, and more often 15 seconds, to ensure that the IUD arms206a,206bof the t-shaped IUD are fully unfolded or expanded to the desired position or configuration. Subsequently, as shown inFIG.4E, the insertion device400is advanced distally until the flange434reaches the external orifice of the cervix420, at which point the IUD arms206a,206bof the t-shaped IUD202contact the fundus416of the uterus.

FIGS.5A-5Billustrate positioning of a t-shaped IUD202during phase 3 of an insertion procedure. The t-shaped IUD202is completely deployed from the insertion device into the uterus (shown as the demonstrator433inFIG.5A).

FIG.5Bprovides a planar view showing a detailed illustration of the relevant female anatomy, including the uterus514, fundus516, openings of the fallopian tubes518a,518b, cervix520, cervical canal521, external orifice522of the cervix520, and internal orifice523of the cervix520. Once inserted, the IUD strings210extend from the uterus514, through the cervix520, and into the vagina524, as shown inFIG.5B.

Upon completion of the IUD insertion phase, post-insertion procedures can be performed, such as removal of the insertion device sheath from the patient and trimming the IUD strings to an appropriate length for a particular patient.

The insertion devices of the present disclosure demonstrate improved device structure and operation technique, as well as increased ease of operability for the user. The insertion devices of the present disclosure are configured to reduce pain and trauma suffered by patients during the IUD insertion procedure. Most women have a cervix which varies in diameter of the opening from about 1 to about 3 millimeters. The size and shape of the cervix varies widely with the patient's age, the patient's hormonal state, and whether the patient has born a child via vaginal birth. However, the IUD and insertion device typically have a diameter larger than the diameter of the cervical canal, especially at the external orifice and internal orifice of the cervix or uterus. Such a mismatch between the diameters of the cervix and insertion device creates a resistive pathway for IUD insertion which can hinder proper insertion of the IUD and result in a traumatic insertion for the patient. Diameters of IUDs and traditional insertion devices are large compared to the typical female human cervical canal into which the IUD and applicator are inserted during the IUD insertion process. As will be appreciated by those skilled in the art, traumatic IUD insertion procedures can cause a variety of adverse side effects including, but not limited to, bleeding, intense pain, and an adverse vasovagal response, which can result in fainting or seizure.

Pain during the IUD insertion procedure is reduced by the structure and operation of the insertion device, as well as by the ease of operability of the insertion device. Traumatic insertion can result from difficulties in operating the IUD insertion tool, malfunctioning of the insertion device, improper IUD positioning during insertion, operator error, and inherent design features of the insertion device itself. The insertion devices of the present disclosure are configured to reduce resistance and friction during the IUD insertion process. The insertion devices are configurable to operate smoothly, quickly, steadily, easily, and in a highly controlled and consistent manner, thereby reducing trauma to the patient during insertion and deployment of the IUD.

The present disclosure provides insertion device structures and operation which controls the position of the IUD during various phases of the insertion procedure. Traditional insertion devices do not provide a reliable mechanism to position the IUD and maintain appropriate IUD positioning throughout the insertion procedure. Securing the IUD in the proper location during multiple stages of insertion is important for proper and painless insertion. Improper IUD positioning such as misalignment and premature or late deployment of the IUD can cause unsuccessful and painful insertion. The present disclosure provides improved position control through the use of position control features for control of both in-plane and longitudinal alignment of the IUD during the insertion procedure. In an aspect of the disclosed devices, the insertion device further includes position control feedback or signal features to provide verification and assurance of proper IUD positioning.

The insertion devices of the present disclosure are configurable to exhibit a high degree of control and accuracy of the position of an IUD during an IUD insertion procedure using one hand. The insertion devices are configured to prevent the sheath slider from advancing distally beyond the distal cavity.

As will be appreciated by those skilled in the art, it is important to control the positioning and alignment of the IUD with a high degree of accuracy during the IUD insertion procedure. For example, in the IUD insertion procedure illustrated inFIGS.3-5and discussed above, it is important to control the longitudinal position of the IUD, in-plane alignment of the IUD, and cross-section of the t-shaped IUD202and insertion device sheath.

As discussed above, the t-shaped IUD202is rotatable r in-plane about longitudinal axis x as shown inFIG.3D, such that the IUD arms or similar features of the IUD will deploy in-line with respective openings of the fallopian tubes518a,518bof the patient, as shown inFIG.5B, to achieve an in-plane alignment. Generally speaking, when an IUD is in an in-plane alignment the IUD is laid flat, or substantially flat, within a plane defined by the openings of fallopian tubes518a,518band cervical canal521, such as the coronal plane shown x-y inFIG.5B. The IUD arms206a,206b, or the like functional feature for a non-t-shaped IUDs, will be positioned near the openings of the fallopian tubes518a,518bwhen the IUD is deployed. The proximal end of the elongated body204of the t-shaped IUD is proximate to the internal orifice523of the cervix, and the IUD strings210extend proximally from the t-shaped IUD202into the vagina524.

During phase 1 of the insertion procedure, as shown inFIGS.4A-4B, the t-shaped IUD202is positioned within an insertion device400such that the t-shaped IUD202will not prematurely deploy but will deploy readily during the transition to phase 2 of the insertion procedure (FIG.4C). The cross-section of a distal end20of the insertion device400is configurable such that it presents a minimal diameter along a longitudinal portion of the insertion device that is inserted into a patient's cervix and uterus, and the distal end20of the insertion device400is further configurable to present a distal end that is rounded or curved, smooth, and free of blunt or abrupt features. The use of a rounded distal tip which is free of blunt or abrupt features reduces or eliminates harm or trauma to the patient and reduces any impediment to smooth insertion of the insertion device through the cervical canal and into the uterus. The t-shaped IUD202is preferably deployed into the uterus having in-plane alignment such that the deployed IUD will be substantially in, for example, a coronal plane as discussed above.

III. IUDs and Hormones

A contraceptive device, which is available on the market and which releases levonorgestrel, consists of a t-shaped IUD202having an elongated body204fabricated of polyethylene equipped with a jacket-like polymeric reservoir220adjusted around the elongated body204. The reservoir220contains an active agent. The active agent includes hormones used for the treatment of menopausal troubles or for contraception, such as levonorgestrel. The IUD is sold in sterile packaging together with the insertion device with the IUD positioned within a protective tube. The t-shaped IUD202is positioned at the forward end (distal end) with the hormone-containing elongate member protected by a sheath or tube. The IUD arms206a,206bof the transverse member, on the other hand, are expanded in order to prevent fatigue. The strings by which the t-shaped device is retracted towards the outside run between the plunger and the protective tube and end at the end of the handle.

FIGS.6A-6Eillustrate an insertion device600.FIGS.6A-6Bare top and side views of the insertion device600.FIG.6Cis a cross-sectional view of a prior version of the insertion device600.FIG.6Dis a cross-section of an embodiment of the insertion device600;FIG.6Eis a cross-section of an alternative embodiment of the insertion device600.FIG.6Fis an exploded view of the insertion device600ofFIG.6A-B;FIG.6Gis an exploded view of the insertion device600ofFIG.6E.

The insertion device600comprises an elongated sheath632or tube having an interior lumen configured to house the IUD prior to deployment, an elongated inner member or plunger that fits within the elongated sheath632, a handle635or housing, an elongated channel638, a first slider that is a sheath slider642having a depression with a first sheath slider alignment surface642A and a second sheath slider alignment surface642B opposite the first sheath slider surface642A, for controlling the translational movement of the elongated sheath632and the elongated inner member relative to one another along a corresponding longitudinal axis of the elongated channel638, and a second slider which is a string control slider646, having a first string control slider alignment surface646A for controlling one or more strings attached to the IUD. The elongated channel638guides movement of the sheath slider642and the string control slider646in a proximal and distal direction along a longitudinal axis.

As explained in further detail below, the string control slider646can control the locking and unlocking of one or more strings attached to the IUD.

The handle635of the insertion device600is adaptable and configurable to provide a housing for insertion device parts such as the elongated sheath632, plunger, and the sheath slider642and the string control slider646, and provides a handle for the operator to hold the insertion device600during operation.

The handle635can have a marking639, such as a single raised line, related to a step in the insertion procedure, e.g., “1” corresponding to phase 1 of the procedure with a corresponding marking on the sheath slider642. The string control slider646and the handle635can have a marking639′, such as two raised lines, related to a step in the insertion procedure, e.g. “2.” The handle635can have another marking639″, also two raised lines related to a step in the insertion procedure, e.g., “3.”

The handle635is further adaptable and configurable to include an elongated channel638which allows user access to the sheath slider642and the string control slider646. As will be appreciated by those skilled in the art, movement of the sliders along the length of the elongated channel638can be one or more of concurrent or independent, at any given time during the procedure.

As illustrated, the sheath slider642is a sheath slider which is attachable to elongated sheath632and directly controls the longitudinal location and translational movement of the elongated sheath632relative to the elongated inner member and IUD as it moved within the elongated channel638. The string control slider646unlocks or releases the strings of the IUD. During an insertion procedure, the operator's thumb is used to move both the sheath slider642and the string control slider646in a proximal direction (i.e., towards the proximal end10) and a distal direction (i.e., towards a distal end20) along the elongated channel638to control the elongated sheath632and IUD strings, respectively. As will be appreciated by those skilled in the art, during routine insertion, the user would only need to move the sliders in the proximal direction. Only if there were a need to reload the IUD would the user move in the distal direction.

The sheath slider642and the string control slider646each have alignment surfaces and move within the elongated channel638along a longitudinal axis in a proximal direction or a distal direction. At the distal end20of the elongated channel638is a cavity645having a cavity alignment surface645′ within the handle635into which at least a portion of the distal end of the sheath slider642can be advanced. Interior features of the handle635and the sheath slider642prevent the sheath slider642from advancing distally to a point where the distal surface of the finger indent660is flush with an edge of the first cavity645a. The second cavity645B has a cavity alignment surface645″ that aligns with the string control slider alignment surface646′ when the string control slider646is in a rearward (proximal) position. The second sheath slider alignment surface642B aligns with the string control slider alignment surface646′ when the string control slider646is in a first rearward (proximal) position, and both the string control slider alignment surface646′ and the cavity alignment surface645″ when both the sheath slider642and the string control slider646are in a is second rearward (proximal) position.

The sheath slider642and the string control slider646have a telescopic configuration, whereby at least one slider slides within or through at least a portion of one other slider along the longitudinal axis. As shown inFIGS.6A-Bfor example, the sheath slider642can slide under a portion of the string control slider646.

The first cavity645ais positioned at a first end of the elongated channel638and the second cavity645B is positioned at a second end of the elongated channel638. The second cavity645B has a cavity alignment surface645″ that aligns with the first sheath slider alignment surface642A when the first sheath slide is in a rearward position. During phase 3 of the insertion procedure, the sheath slider642and string control slider646are in the full proximal position along the longitudinal axis of the elongated channel638, and at least partially surrounded by the second cavity645B.

Additional visual indication features and/or tactile features can be provided. Visual indication features can be provided on the elongated sheath632, the handle635, or both. The proximal end of the handle has a string control surface648. The string control surface648also provides a visual indicator for the user that the strings of the IUD have been released during the insertion process. As noted above, the numbers1,2, and3on 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, carving, 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. Additionally, the visual indicators can be both visible and tactile.

As shown inFIG.6C, an interior of a prior version of the insertion device600included detent ribs641,641′ of the string control slider646that flexed within the plane of the ultrasonic weld of the handle halves. The detent ribs641,641′ within the plane of the ultrasonic weld of the handle635halves led to detent force variability.

As shown inFIG.6D, the distally positioned sheath slider detent arms672,673have been reconfigured so that the distally positioned sheath slider detent arms672,673flex 90 degrees relative to the ultrasonic weld plane of the handle halves. In one configuration, the sheath slider642has distally positioned sheath slider detent arms672,673on either side of both the top and bottom halves of the sheath slider642, as shown in more detail inFIG.7A.

FIG.6E, is an alternative configuration, where each half of the sheath slider642has one detent arm. When the two halves of the sheath slider642are mated, a detent arm is positioned on each side of the sheath slider642, as shown in more detail inFIG.7B. The distally positioned sheath slider detent arms672,673are positioned on either side of the sheath slider642when the two pieces of the sheath slider are assembly. The distally positioned sheath slider detent arms672,673can be positioned on both sides of each half of the sheath slider642, on both sides of one half of the sheath slider642, or on opposing sides of each half of the sheath slider642.

FIG.6Fis an exploded view of the insertion device600ofFIG.6D.FIG.6Gis an exploded view of the insertion device600ofFIG.6E. The insertion device600includes a handle635, shown in two pieces. The handle has an elongated channel638or guide and a distal cavity or first cavity645A and a proximal cavity or second cavity645B which faces the first cavity645A at an opposite side of the elongated channel638. A sheath slider642is positioned distally relative to a string control slider646. An elongated sheath632, a plunger634and a flange633is provided.

FIG.7Aillustrates additional detail of the sheath slider642shown inFIG.6E. The top half of the sheath slider642has a pair of lateral rails670,670′ on either side of the sheath slider642. The lateral rails670,670′ fit within a channel on either side of the housing (shown inFIG.9). A pair of distally positioned sheath slider detent arms672,673are provided distal to the lateral rails670. The distally positioned sheath slider detent arm672s672,673are lateral flexing detent arms.

FIG.7Billustrates additional detail of the sheath slider642shown inFIG.6E. The top half of the sheath slider642has a pair of lateral rails670,670′ on either side of the sheath slider642. The pair of lateral rails670,670′ fit within a channel in the housing (shown inFIG.9). A distally positioned sheath slider detent arm673is provided distal to the lateral rails670. The distally positioned sheath slider detent arm673is a lateral flexing detent arm. In one configuration, the bottom half of the sheath slider642could have a distally positioned sheath slider detent arm on a side opposite the distally positioned sheath slider detent arm673so that when the top and bottom of the sheath slider642are mated, a sheath slider detent arms extend from either side of the sheath slider642.

FIG.7Cillustrates the sheath slider642shown inFIG.7Apositioned within a portion of the housing for the handle635. A pair of lateral ribs674,675which extend from an interior surface of the housing of the handle635engage the distally positioned sheath slider detent arms672,673. The sheath slider642engages the elongated sheath632at a distal end20, and a string control slider646at a proximal end10. The sheath slider642has a visual indicator, such as a “1” on a concave upper surface. The concave upper surface is designed to fit a finger of a user during one-handed use of the IUD insertion device.

FIG.7Dillustrates the sheath slider642shown inFIG.7Bpositioned within a portion of the housing of the handle635. A lateral rib675extends from an interior surface of bottom half of the housing of the handle635to engage a proximal surface of the lateral rib675. The sheath slider642engages the elongated sheath632at a distal end20. and a string control slider646at a proximal end10.

FIG.8illustrates the sheath slider642positioned partially within a cavity formed in the string control slider646with a first sheath hard stop surface690on an interior surface of the string control slider646. The first sheath hard stop surface690prevents the sheath slider642from moving proximally past the string control slider646during use.

FIG.9illustrates another view of the sheath slider642positioned partially nested within a cavity formed in the string control slider646with a first sheath hard stop surface690on an interior surface of the string control slider646. The channel686that the one of the lateral rails670fits within can be appreciated from this view.

FIG.10illustrates a distal end20of the insertion device600ofFIG.6A. The t-shaped IUD202is positioned in the distal end20of the elongated sheath632. The plunger634engages the proximal end10of the t-shaped IUD202without the use of any additional tube segment.

FIG.11illustrates an interior view of a distal portion of the handle635adjacent the elongated sheath632shown inFIG.6C. An elongated sheath hard stop surface692is provided which eliminates the need to provide an inner sleeve inside the elongated sheath632to prevent further movement of the elongated sheath632.

FIGS.12A-12Cillustrate elements of the insertion device600during various steps of the insertion process.FIG.12Aillustrates an interior of the insertion device in position 1 at the beginning of the insertion procedure (phase 1) when the sheath slider642ofFIG.6Ais in a distal position. As shown in the cut-away, the distally positioned sheath slider detent arms672,673engage the lateral ribs674,675on the bottom half of the handle635.

FIG.12Billustrates position 1 of an alternate embodiment at the beginning of the insertion procedure (phase 1) when the sheath slider642is in a distal position. As shown in the cut-away, one of the distally positioned sheath slider detent arms672is positioned on the lower portion of the sheath slider642and would engage a lateral rib positioned within the upper half of the handle (not shown). A lateral rib675is shown on the opposing side of the bottom half of the handle635, which would engage a lateral rib positioned within the upper portion of the sheath slider.

FIG.12Cillustrates an interior of the insertion device in position 2 midway during the procedure (phase 2). Interiorly engaging string control slider detent arms680,681are positioned proximal to the distally positioned sheath slider detent arms672,673. The interiorly engaging string control slider detent arms680,681engage a pair of ribs684,685which engage the plunger634on one side and the interiorly engage string control slider detent arms680,681on the other side. The interiorly engaging string control slider detent arms680,681of position 2 (phase 2) provide the user tactile feedback that they have reached the second position. When this feedback occurs, the user then waits 15 seconds for the IUD arms to come down. Then the user moves the sheath slider642together with the string control slider646out of position 2 and proximally into position 3.

FIG.12Da proximal end10of the interior of the handle635during position 3 showing the proximal end of the string control slider646. A pair of outwardly facing string control slider detent arms682,683. The outwardly facing string control slider detent arms682,683at position 3 again provide the user tactile feedback and an audible click to let the user know that position 3 has been reached.FIG.12Dillustrates the string control slider at position 3 with the outwardly facing string control slider detent arms682,683engaging the proximal handle ribs687,688. Additional locating features693,694shown inFIG.12Eare provided which assist in achieving proper alignment and quick positioning of the two handles prior to ultrasonic welding. The locating features are illustrated as an “O” and a “+” to distinguish a first locating feature on a first side of the handle635and a second locating feature on a second side of the handle635opposite the first side of the handle.

Turning toFIGS.13A-C, the bottom half of the sheath slider642illustrating an interior surface has a plurality of internal curved ribs695(illustrated as three ribs) with a pair of tensile holders696,696′ on an upper surface of one or more of the internal curved ribs695. The pair of tensile holders696,696′ provide additional tensile holding strength for the sheath slider642during use. Thus, inFIG.13A, there are three internal curved ribs695wherein each of the three internal curved ribs each have two tensile holders, for a total of six tensile holders.FIG.13Billustrates the use of alternating the tensile holders696and torsional holder697at a 90 degree angle from the tensile holder which provides additional torsional strength during use. Thus, inFIG.13B, there are also three internal curved ribs695. In this configuration, two of the internal curved ribs have two tensile holders, for a total of four tensile holders, and the third rib (the center rib) has a torsional holder697.

The bottom half of the sheath slider642inFIG.13Ahas a pair of distally positioned sheath slider detent arms672,673. The configuration illustrated inFIG.13Bshows the bottom portion of the sheath slider642with only one of the distally positioned sheath slider detent arms672. As will be appreciated by those skilled in the art, the configuration ofFIG.13Ahaving two of the distally positioned sheath slider detent arms672,673can have a single detent arm and/or can have tensile holders696on one or more of the internal curved ribs695or can have a combination of tensile holders696and torsional holder697. Similarly, the configuration shown inFIG.13Bcan have two detent arms.FIG.13Cillustrates a bottom portion and interior surface of a sheath slider642with a torsional holder697at a front curved surface.

FIG.14illustrates a cut away of the housing forming the handle635. A tongue and groove interface698is provided to improve the weld strength of the handle. Additionally rails699can be provided to increase rigidity of the handle635.

FIG.15illustrates the proximal end10of the handle635and the string control surface648which has a radiused edge instead of a sharp edge. Use of a radiused edge helps prevent the strings from being damaged or cut by the device during the insertion process.

FIG.16illustrates the string control slider646which is a single molded part. The string control slider646has a proximal end10and a distal end20. An interiorly facing channel686is formed along a portion of the length at the distal end in which the lateral rails of the sheath slider moves. The string control slider646has two pairs of detents. A first pair of interiorly engaging string control slider detent arms680,681is positioned proximally relative to a pair of outwardly facing string control slider detent arms682,683. A pair of flexible arms649are positioned about the proximal end10of the string control slider646and positioned in a plane that is perpendicular to the plane in which the interiorly engaging string control slider detent arms680,681and outwardly facing string control slider detent arms682,683are positioned.

FIGS.17A-Cillustrate the proximal and distal end of the insertion device at phase 1 of the insertion process (FIG.17A), phase 2 of the insertion process (FIG.17B) and phase 3 of the insertion process (FIG.17C). At each phase of the process, tactile feedback can be provided to the user when the interior components described and shown above are engaged.

InFIG.17A, during phase 1, the t-shaped IUD202is loaded into the elongated sheath by pulling on the IUD strings210and is shown positioned within the interior of the elongated sheath632when the sheath slider642is positioned at a distal most position within the elongated channel in the handle635. The distal surface of the sheath slider642aligns with the edge of the first cavity645a. Additionally, the style of the marking639on the exterior surface of the handle635can align with a marking on the surface of the sheath slider642(shown as a single raised rib).

During phase 2, shown inFIG.17B, the sheath slider642is moved proximally (towards the user) and slides under a portion of the string control slider646at which point, the plunger positioned within the elongated sheath632pushes the t-shaped IUD partially out of the distal end of the elongated sheath632. The user will feel a click when the distally positioned sheath slider detent arms672,673shown inFIG.6Dmove past the lateral ribs674,675.—The IUD arms extend laterally away from a central axis, while the elongated body remains within the interior of the elongated sheath632. During this phase the marking639on the handle635can align with markings on the string control slider646(shown as two adjacent raised ribs). When the sheath slider642is positioned optimally with respect to the string control slider646, the proximal surface of the sheath slider642aligns with a surface of the string control slider646a. Additionally, the interiorly engaging string control slider detent arms680,681engage a pair of ribs684,685which engage the plunger634on one side and the interiorly engage string control slider detent arms680,681on the other side.

As shown inFIG.17C, during phase 3, the sheath slider642and string control slider646are drawn further back in the channel at which point the entire t-shaped IUD is released from the distal end of the elongated sheath632. The user will feel a click when the sheath slider642and string control slider646are moved together and an additional click when reaching the full proximal position. The sheath slider642and string control slider646are in the full proximal position along the longitudinal axis of the elongated channel638, and at least partially surrounded by the second cavity645B.