insertion device for an IUD and kit

专利摘要:
INSERTION DEVICE AND KIT. The present invention relates to an intrauterine system (insertion device) which includes an intrauterine device (IUD), an inserter or applicator for inserting the IUD (202, 302, 402, 502, 3102, 3202) into the cervix of a female patient, methods relating to the insertion procedure, and manufacturing methods for the insertion device.
公开号:BR112014000440B1
申请号:R112014000440-4
申请日:2012-07-09
公开日:2021-05-25
发明作者:Rob Deckman；Richard E. Repp；Curt Guyer；Justin Westendorf；Timothy PARMER
申请人:Medicines360；
IPC主号:

专利说明:

CROSS REFERENCE
[0001] This application claims the benefit of US Utility Application Number 13/539,843, filed July 2, 2012, which claims the benefit of US Provisional Application Number 61/506,434, filed July 11, 2011, which application is incorporated herein by reference. BACKGROUND OF THE INVENTION FIELD OF THE INVENTION
[0002] The description refers to intra-urinary systems, intrauterine devices (IUDs), insertion devices, methods of use, and kits therefor. BACKGROUND OF THE INVENTION
[0003] An intrauterine device (IUD) is an object that, when placed inside a female's uterus, acts as a birth control device to prevent pregnancy. Two types of IUDs are commonly available, devices that contain poor and devices that contain hormones that release progestin. Devices containing hormones are considered to be a different form of birth control and can be distinguished in the literature by the term intrauterine system (IUS).
[0004] Functional copper IUDs negatively affect sperm motility and prevent sperm from attaching to an egg. In addition, the copper foreign body positioned inside the uterus also irritates the uterine lining and the uterine wall, making it difficult for an embryo to settle into the wall if the egg is fertilized by sperm. IUS devices such as the Mirena® hormonal IUD (marketed by Bayer) reduce or prevent menstrual bleeding. The Mirena® device releases levonorgestres1 (a progestogen).
[0005] A variety of shapes and sizes have previously been described for IUD devices. See, for example, U.S. Patent 3,407,806 to Hulka et al for Contraceptive Intrauterine Devices issued October 29, 1968; 3,902,483 for Place and others for Intrauterine Device with Locator Means to Indicate Uterine Device Position issued September 2, 1975; 4,372,302 to Akerlund for Instrument for Retrieval of Retracted Threads from Intrauterine Contraceptive Devices issued February 8, 1983; 3,973,217 to Kosenen for Intrauterine Contraceptive Device issued February 10, 1976; 4,353,363 for Sopena Quesada for Intrauterine Spermicide issued October 12, 1982; 4,359,046 to Shaw Jr. for IUD Disposition issued November 16, 1982; 4,381,001 to Shaw Jr. for IUD Disposition issued April 26, 1983; 4,495,934 to Shaw Jr. for IUD Disposition issued January 29, 1985; 4,830,025 to Gainutdinova et al. for Intrauterine Contraceptive Device issued May 16, 1989; 4,957,119 para de Nijs for Contraceptive Implant issued September 18, 1990; 5,088,505 para de Nijs for Contraceptive Implant issued on February 18, 1992; 6,039,968 to Nabahi for Intravaginal Drug Delivery Device issued March 21, 2000; 7,862,552 to McIntyre and others for Medical Devices to Treat Urological and Uterine Conditions issued January 4, 2011; and U.S. Patent Publications 2005/0045183 A1 to Callister et al. for Methods and Devices issued and March 3, 2005.
[0006] IUDs are typically inserted using an insertion device or instrument. See, for example, U.S. Patent 3,783,861 to Abramson for Inserter for Intrauterine Devices issued January 8, 1974; 3,794,025 to Lerner for Intrauterine Device Saddle Inserter issued February 26, 1974; 4,920,727 to Ristimaki and others for Cassette System and Apparatus to Fabricate an Active Agent Release Capsule for Subcutaneous Use issued May 1, 1990; 4,949,732 to Spoon and others for Apparatus for Insertion and Attachment of an Intrauterine Contraceptive Device to the Fundus Uterine issued and, August 21, 1990; 5,084,004 to Ranoux for Process for Intrauterine Fertilization in Mammals and Device for Its Implementation issued January 28, 1992; 5,370,129 to Diaz et al for IUD Insertion Apparatus issued December 6, 1994; 5,400,804 to Helle et al. for Method and Equipment for Installing a Medical Capsule in a Holder issued March 28, 1995; 5,785,053 to Macandrew and others for Inserter for the Positioning of an Intrauterine Device issued July 28, 1998.
[0007] Other references of interest in the field of IUS and IUD include, for example, U.S. Patent 6,056,76 to Markkula et al. for Elastomer, Its Preparation and Use issued May 2, 2000; 6,063,395 to Markkula and others for Drug Delivery Device Specially for the Delivery of Progestins and Estrogens issued May 16, 2000; 6,103,256 to Nahabi for Intravaginal Drug Delivery Device issued August 15, 2000; 6,117,442 to Markkula and others for Drug Delivery Device, Especially for Androgen Delivery issued September 12, 2000; and U.S. Patent Publication US 2008/0095825 A1 to LaFont for Method of Making a Reservoir Containing a Diffuse Active Substance through the Reservoir and Installation Therefor published April 24, 2008.
[0008] Conventional insertion devices used with IUDs (which include devices used for IUSs) can cause pain and even loss of consciousness to a patient during the insertion procedure as a result of inducing a vagal reflex response. Conventional inserters lack smooth operability and exhibit problems with ease of use. Thus, there is a need for an adaptable and configurable insertion device for use with IUDs and related methods and kits which reduce patient pain and trauma during the insertion procedure and provide a simple, high quality, easy to use solution, it operates smoothly, economical. SUMMARY OF THE INVENTION
[0009] One aspect of the description is directed to inserters comprising: an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end; an elongated inner member having a proximal end and a distal end available within the lumen of the elongated sheath; a proximally positioned user interface, wherein the proximally positioned user interface further comprises one or more elongated guides formed at least partially therefrom and along at least a portion of a length thereof; and a movable sheath slider in communication with the elongated sheath wherein the movable sheath slider is adaptable and configurable to move securely within the elongated guide and further wherein the movable sheath slider controls axial movement of the elongated sheath. The elongated guide is further configurable to comprise one or more motion control features along the length of the elongated guide. In addition, the one or more motion control characteristics are selected from the group comprising a hard motion control characteristic, a soft motion control characteristic. Furthermore, the one or more motion control features comprise at least one configurable force limiting feature to limit an amount of force applied to the movable sheath slide. The one or more motion control features are selectable from the group comprising stops, notches, grooves, protrusions, tabs, edges, flanges, flaps, ports, flexible members, elongated guide contours, and elongated guide curved surface. Furthermore, the elongated guide has a length, a width and a depth, further wherein the elongated guide width is at least one of a variable length and a selected stepped width of two or more of a first width and a second width . The elongated guide may further be configured to have a profile in the plane selected from rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semicircular, and oval. The sheath slider may also be configured to comprise one or more surface profiles adapted and configured to mechanically complement the one or more motion control features. The one or more sheath slide surface profiles are selected from the group comprising one or more each of non-planar surfaces, curved surfaces, and sloped surfaces. In addition, the sheath slider housing further comprises one or more alignment surfaces, wherein the one or more housing alignment surfaces are adapted and configured to mechanically complement the one or more sheath alignment surfaces. In at least some configurations, a first sheath slider alignment surface aligns with a first housing alignment surface at a first position along the length of the elongated guide. In addition, the one or more sheath slide alignment surfaces and the one or more housing alignment surfaces are selected from the group comprising a curved surface, an angled surface, an inclined surface, and a dimensional surface. The elongate guide may further be configured to comprise one or more recesses over one or more of the proximal end of the elongate guide and the distal end of the elongate guide wherein the one or more recesses are adapted and configured to accommodate at least a portion of the elongate guide. mobile sheath. In at least some configurations, the devices further comprise a lanyard control slide. The bead control slide can be adaptable and configurable to safely move within the elongated guide. Furthermore, the elongated sheath slide and the cord control slide are adapted and configured to operate at least one of simultaneously and independently within one or more elongated guides. In at least some configurations, the sheath slide and the bead control slide are telescopically movable along at least a first portion of the elongated guide, and further wherein the sheath slide and the bead control slide are configurable from so that at least one of the sheath slide and the cord slide partially surrounds the remaining slide. The sheath slide and the bead control slide are further configurable to comprise one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group comprising a first vertical sheath slide surface, a second vertical surface of hem slide, a bead control slide first vertical surface and a bead control slide second vertical surface, wherein one or more of the vertical surfaces are configured to form an adjacent surface aligned at one or more positions along the length of elongated guide. Typically, devices are configurable so that the sheath slide and bead control slide have a combined width less than or equal to at least one of 19 mm (0.75 inches), 17.8 mm (0, 7 inches), 12.7 mm (0.5 inches), 8.9 mm (0.35 inches), or 6.3 mm (0.25 inches). The inserter is also configurable to receive an IUD within the distal end of the elongated sheath lumen further comprising at least one adaptable and configurable cord locking feature for securing one or more cord components of the IUD. In some configurations the at least one strand locking feature comprises one or more of a slot, a clamp, a wedge, a clamp, a spring, or teeth. In other embodiments, the strand locking feature comprises a slit, and the strand unlocking feature comprises a movable member which pushes the one or more strands out of the slit to unlock the one or more strands. The distal end of the elongated sheath is also configurable so that it has an atraumatic tip selected from the group comprising a rounded tip and a tapered tip. The distal end of the elongated sheath has an outside diameter of approximately 3mm to 5mm. In some configurations, the distal end of the elongated sheath has an outside diameter which is equal to or less than 80%, 50%, 30% of the outside diameter of the proximal end of the elongated sheath. In addition, the distal end of the elongated sheath is configurable so that it has an outside diameter which is less than the maximum cross-sectional dimension of an IUD positionable within the lumen of the elongated sheath. In at least some configurations, the distal end of the elongated sheath further comprises one or more slits or tabs in the forward end of the sheath. Furthermore, one or more feedback mechanisms may be provided which are selected from the group comprising audible, visible, and tactile.
[00010] Another aspect of the description is directed to inserters comprising: an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end; an elongated inner member having a proximal end and a distal end available within at least a portion of the lumen of the elongated sheath; a proximally positioned user interface; and an actuatable sheath control knob associated with the proximally positioned user interface in communication with the elongated sheath wherein the actuable sheath control knob is adaptable and configurable to control axial movement of the elongated sheath where the elongated sheath extends distally the housing, and where the hem control button causes the hem to recede closer when the hem control button is actuated. The elongated guide is further configurable to comprise one or more motion control features along the length of the elongated guide. In addition, the one or more motion control characteristics are selected from the group comprising a hard motion control characteristic, a soft motion control characteristic. Furthermore, the one or more motion control features comprise at least one configurable force limiting feature to limit an amount of force applied to the movable sheath slide. The one or more motion control features are selectable from the group comprising stops, notches, grooves, protrusions, tabs, edges, flanges, flaps, ports, flexible members, elongated guide contours, and elongated guide curved surface. Furthermore, the elongated guide has a length, a width and a depth, further wherein the elongated guide width is at least one of a variable length and a selected stepped width of two or more of a first width and a second width . The elongated guide may further be configured to have a profile in the plane selected from rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semicircular, and oval. The sheath slider may also be configured to comprise one or more surface profiles adapted and configured to mechanically complement the one or more motion control features. The one or more sheath slide surface profiles are selected from the group comprising one or more each of non-planar surfaces, curved surfaces, and sloped surfaces. Furthermore, the housing and the sheath slide further comprise one or more alignment surfaces, wherein the one or more housing alignment surfaces are adapted and configured to mechanically complement the one or more sheath alignment surfaces. In at least some configurations, a first sheath slider alignment surface aligns with a first housing alignment surface at a first position along the length of the elongated guide. In addition, the one or more sheath slide alignment surfaces and the one or more housing alignment surfaces are selected from the group comprising a curved surface, an angled surface, an inclined surface, and a dimensional surface. In at least some configurations, the sheath slide and the bead control slide are telescopically movable along at least a first portion of the elongated guide, and further wherein the sheath slide and the bead control slide are configurable from so that at least one of the sheath slide and the cord slide partially surrounds the remaining slide. The sheath slide and the bead control slide are further configurable to comprise one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group comprising a first vertical sheath slide surface, a second vertical surface of hem slide, a bead control slide first vertical surface and a bead control slide second vertical surface, wherein one or more of the vertical surfaces are configured to form an adjacent surface aligned at one or more positions along the length of elongated guide. Typically, devices are configurable so that the sheath slide and bead control slide have a combined width less than or equal to at least one of 19 mm (0.75 inch), 17.8 mm (0, 7 inch), 12.7 mm (0.5 inch), 8.9 mm (0.35 inch), or 6.3 mm (0.25 inch). The inserter is also configurable to receive an IUD within the distal end of the elongated sheath lumen further comprising at least one adaptable and configurable cord locking feature for securing one or more cord components of the IUD. In some configurations the at least one strand locking feature comprises one or more of a slot, a clamp, a wedge, a clamp, a spring, or teeth. In other embodiments, the strand locking feature comprises a slit, and the strand unlocking feature comprises a movable member which pushes the one or more strands out of the slit to unlock the one or more strands. The distal end of the elongated sheath is also configurable so that it has an atraumatic tip selected from the group comprising a rounded tip and a tapered tip. The distal end of the elongated sheath has an outside diameter of approximately 3mm to 5mm. In some configurations, the distal end of the elongated sheath has an outside diameter which is equal to or less than 80%, 50%, 30% of the outside diameter of the proximal end of the elongated sheath. In addition, the distal end of the elongated sheath is configurable so that it has an outside diameter which is less than the maximum cross-sectional dimension of an IUD positionable within the lumen of the elongated sheath. In at least some configurations, the distal end of the elongated sheath further comprises one or more slits or tabs in the forward end of the sheath. In some configurations, the hem control knob and bead control knob are available adjacent to each other on the housing.
[00011] Yet another aspect of the description is directed to inserters comprising: an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end wherein the distal end of the elongated sheath forms an atraumatic tip selected from the group comprising a rounded tip and a sharpened tip; an elongated inner member having a proximal end and a distal end available within the lumen of the elongated sheath; and a proximally positioned user interface. The elongated guide is further configurable to comprise one or more motion control features along the length of the elongated guide. In addition, the one or more motion control characteristics are selected from the group comprising a hard motion control characteristic, a soft motion control characteristic. Furthermore, the one or more motion control features comprise at least one configurable force limiting feature to limit an amount of force applied to the movable sheath slide. The one or more motion control features are selectable from the group comprising stops, notches, grooves, protrusions, tabs, edges, flanges, flaps, ports, flexible members, elongated guide contours, and elongated guide curved surface. Furthermore, the elongated guide has a length, a width and a depth, further wherein the elongated guide width is at least one of a variable length and a selected stepped width of two or more of a first width and a second width . The elongated guide may further be configured to have a profile in the plane selected from rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semicircular, and oval. The sheath slider may also be configured to comprise one or more surface profiles adapted and configured to mechanically complement the one or more motion control features. The one or more sheath slide surface profiles are selected from the group comprising one or more each of non-planar surfaces, curved surfaces, and sloped surfaces. In addition, the sheath slider housing further comprises one or more alignment surfaces, wherein the one or more housing alignment surfaces are adapted and configured to mechanically complement the one or more sheath alignment surfaces. In at least some configurations, a first sheath slider alignment surface aligns with a first housing alignment surface at a first position along the length of the elongated guide. In addition, the one or more sheath slide alignment surfaces and the one or more housing alignment surfaces are selected from the group comprising a curved surface, an angled surface, an inclined surface, and a dimensional surface. The elongate guide may further be configured to comprise one or more recesses over one or more of the proximal end of the elongate guide and the distal end of the elongate guide wherein the one or more recesses are adapted and configured to accommodate at least a portion of the elongate guide. mobile sheath. In at least some configurations, the devices further comprise a lanyard control slide. The bead control slide can be adaptable and configurable to safely move within the elongated guide. Furthermore, the elongated sheath slide and the cord control slide are adapted and configured to operate at least one of simultaneously and independently within one or more elongated guides. In at least some configurations, the sheath slide and the bead control slide are telescopically movable along at least a first portion of the elongated guide, and further wherein the sheath slide and the bead control slide are configurable from so that at least one of the sheath slide and the cord slide partially surrounds the remaining slide. The sheath slide and the bead control slide are further configurable to comprise one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group comprising a first vertical sheath slide surface, a second vertical surface of hem slide, a bead control slide first vertical surface and a bead control slide second vertical surface, wherein one or more of the vertical surfaces are configured to form an adjacent surface aligned at one or more positions along the length of elongated guide. Typically, devices are configurable so that the sheath slide and bead control slide have a combined width less than or equal to at least one of 19 mm (0.75 inch), 17.8 mm (0, 7 inch), 12.7 mm (0.5 inch), 8.9 mm (0.35 inch), or 6.3 mm (0.25 inch). The inserter is also configurable to receive an IUD within the distal end of the elongated sheath lumen further comprising at least one adaptable and configurable cord locking feature for securing one or more cord components of the IUD. In some configurations the at least one strand locking feature comprises one or more of a slot, a clamp, a wedge, a clamp, a spring, or teeth. In other embodiments, the strand locking feature comprises a slit, and the strand unlocking feature comprises a movable member which pushes the one or more strands out of the slit to unlock the one or more strands. The distal end of the elongated sheath has an outside diameter of approximately 3mm to 5mm. In some configurations, the distal end of the elongated sheath has an outside diameter which is equal to or less than 80%, 50%, 30% of the outside diameter of the proximal end of the elongated sheath. In addition, the distal end of the elongated sheath is configurable so that it has an outside diameter which is less than the maximum cross-sectional dimension of an IUD positionable within the lumen of the elongated sheath. In at least some configurations, the distal end of the elongated sheath further comprises one or more slits or tabs in the forward end of the sheath. Furthermore, one or more feedback mechanisms may be provided which are selected from the group comprising audible, visible, and tactile. In at least some configurations, the device further comprises one or more motion control features along the length of the elongated guide.
[00012] A further aspect of the description is directed to kits comprising: an inserter having an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end; an elongated inner member having a proximal end and a distal end available within the lumen of the elongated sheath; a proximally positioned user interface, wherein the proximally positioned user interface further comprises one or more elongated guides formed at least partially therein and along at least a portion of a length thereof; and a movable sheath slider in communication with the elongated sheath wherein the movable sheath slider is adaptable and configurable to move securely within the elongated guide and further wherein the movable sheath slider controls axial movement of the elongated sheath; and an intrauterine device positioned within the distal lumen of the elongated sheath.
[00013] Still other aspects of the description are directed to kits comprising: an insertion device having an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end; an elongated inner member having a proximal end and a distal end available within the lumen of the elongated sheath, a proximally positioned user interface, and an actuable sheath control knob associated with the proximally positioned user interface in communication with the elongated sheath wherein the actuatable sheath slider is adaptable and configurable to control axial movement of the elongated sheath, wherein the elongated sheath extends outward from the housing, and wherein the sheath control knob causes the sheath to recede closer when the Sheath control button is actuated, and an intrauterine device is positioned within the distal lumen of the elongated sheath.
[00014] Yet another aspect of the description is directed to kits comprising: an inserter having an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein distal end of the elongated sheath forms an atraumatic tip selected from the group comprising a rounded tip and a tapered tip, an elongated inner member having a proximal end and a distal end available within the lumen of the elongated sheath, and a proximally positioned user interface; and an intrauterine device positioned within the distal lumen of the elongated sheath.
[00015] Still other aspects of the description are directed to methods for using an inserter comprising: advancing an inserter having an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end; an elongated inner member having a proximal end and a distal end available within the lumen of the elongated sheath; a proximally positioned user interface, wherein the proximally positioned user interface further comprises one or more elongated guides formed at least partially therein and along at least a portion of a length thereof; and a movable sheath slider in communication with the elongated sheath wherein the movable sheath slider is adaptable and configurable to move securely within the elongated guide and further wherein the movable sheath slider controls axial movement of the elongated sheath; actuate the sheath slide; at least one of moving the elongated sheath closer and advancing the IUD distally; automatically or semi-automatically increasing the radial diameter of the IUD; and release the IUD from the insertion device.
[00016] Additional aspects of the description are directed to methods for using an inserter comprising: advancing an inserter having an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end, an elongated inner member having a proximal end and a distal end available within the elongated sheath lumen, a proximally positioned user interface, and an actuable sheath control knob associated with the proximally positioned user interface in communication with the elongated sheath wherein the actuatable sheath slider is adaptable and configurable to control axial movement of the elongated sheath, wherein the elongated sheath extends outwardly from the housing, and wherein the sheath control knob causes the sheath to retract to closest when the hem control button is actuated; actuate the hem control button; at least one of moving the elongated sheath closer and advancing the IUD distally; automatically or semi-automatically increasing the radial diameter of the IUD; and release the IUD from the insertion device.
[00017] The description also contemplates methods for using an inserter comprising: advancing an inserter having an elongated sheath having a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the distal end of the elongated sheath forms an atraumatic tip selected from the group comprising a rounded tip and a tapered tip, an elongated inner member having a proximal end and a distal end available within the elongated sheath lumen, and a user interface positioned proximally; at least one of moving the elongated sheath closer and advancing the IUD distally; automatically or semi-automatically increasing the radial diameter of the IUD; and release the IUD from the insertion device. INCORPORATION BY REFERENCE
[00018] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference to the same degree as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS
[00019] The accompanying drawings, which are incorporated herein and form part of the specification, illustrate the present invention and, together with the description, further serve to explain the principles of the invention and allow a person skilled in the pertinent art to make and use the invention.
[00020] Figures 1A-1C illustrate a conventional IUD insertion device;
[00021] Figure 2 illustrates a conventional T-shaped IUD;
[00022] Figures 3A-3E illustrate the positioning of an IUD during the first phase of IUD insertion;
[00023] Figures 4A-4C illustrate an animation of positioning an IUD within an insertion device during the transition from the first stage (1) to the second stage (2) of IUD insertion, and Figures 4D-4F illustrate the positioning an IUD with the insertion device during the second phase of IUD insertion;
[00024] Figures 5A-5C illustrate an IUD positioning during the third stage of insertion;
[00025] Figure 6A illustrates a top view of an inserter, and Figures 6B-6D illustrate details of insert handle, slide, and slot features;
[00026] Figures 7A-7C illustrate various slot features and configurations suitable for incorporation into an inserter handle;
[00027] Figure 8A illustrates a top view, and 8B illustrates a side view of an inserter; Figure 8C illustrates an exploded view of the device of Figures 8A-8B, showing the individual components and a method for assembling the device; Figures 8D-8F show a side view of the device with the slide in different positions;
[00028] Figures 9A and 9B illustrate the position control characteristics of an insertion device;
[00029] Figure 10A illustrates a perspective view of an inserter; Figure 10B illustrates a top view, and Figure 10C illustrates a side view of the inserter shown in Figure 10A. Figures 10D-10F illustrate operational positioning of the insertion device during a first, second, and third phase of an IUD insertion procedure;
[00030] Figure 11 illustrates an inserter having multiple slides;
[00031] Figure 12A illustrates a top view and Figure 12B illustrates a side view of an inserter;
[00032] Figure 13A illustrates a top view and Figure 13B illustrates a side view of an inserter with telescopic slides;
[00033] Figure 14A illustrates a top view and Figure 14B illustrates a side view of an inserter with telescopic slides;
[00034] Figures 15A-15C illustrate an operational positioning of the insertion device comprising telescopic sliders during the first, second, and third stages of an IUD insertion procedure;
[00035] Figures 16A-16C illustrate an inserter having a position control feature that includes a crank system;
[00036] Figures 17A-17C illustrate an inserter having a position control feature that includes a crank system;
[00037] Figures 18A-18B illustrate an inserter having a position control feature that includes a gear system;
[00038] Figures 19A-19B illustrate an insertion device having a position control feature that includes a gear and ratchet system;
[00039] Figure 20A illustrates a top view, and Figures 20B-20D illustrate cross-sectional side views of telescopic control buttons, operable to control the components of the inserter;
[00040] Figures 21A illustrates a top view, and Figures 21B-21D illustrates cross-sectional side views of telescopic control knobs, operable for controlling the components of the inserter;
[00041] Figures 22A-22C illustrate cross-sectional side views illustrating a mechanism of action of an actuatable sheath position control knob.
[00042] Figures 23A-23E illustrate various IUD position control features of the plunger and inserter sheath;
[00043] Figures 24A-24G illustrate various aspects of the elongated inserter sheath and atraumatic sheath tip.
[00044] Figures 25A-25B illustrate various lanyard locking features;
[00045] Figures 26A-26E illustrate various lanyard control features, including lanyard locking and lanyard unlocking features;
[00046] Figures 27A-27C illustrate various lanyard control features, including lanyard locking and lanyard unlocking features;
[00047] Figure 28 illustrates an exemplary aspect of an inserter that includes lanyard control features;
[00048] Figures 29A-29D illustrate various bead control features, including bead locking and bead unlocking features, as well as sheath alignment features;
[00049] Figures 30A-30B illustrate indication features of the inserter;
[00050] Figures 31A-31B illustrate features of the inserter sheath, including IUD loading features and methods; and
[00051] Figures 32A-32B illustrate IUD loading characteristics and methods. DETAILED DESCRIPTION OF THE INVENTION I. INSERTION PROCEDURE
[00052] Conventional intrauterine insertion devices include an inserter or insertion device such as the device shown in Figures 1A-1C, which includes a sheath 132 having a proximal end and a distal end and a lumen extending between the end. proximal and distal end for housing the IUD, a plunger 134 for pushing the IUD through the sheath, and a user interface such as a handle 135 for holding the insertion device. The device shown in Figures 1A-1C requires a two-handed procedure, whereby the operator holds the handle 135 in one hand and the sheath 132 in the other hand.
[00053] As will be discussed below in more detail in contrast to conventional inserters as shown in Figure 1, the inserters of the present description are configured to house an IUD during the insertion procedure and are further configured to assist 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 device is adaptable and configurable for insertion of a variety of IUD configurations.
[00054] Insertion devices can, for example, be used with a T-shaped 202 IUD, such as the IUD as shown in Figure 2. IUDs typically have a length of approximately 31.90 mm to approximately 32.22 mm mm and a width of approximately 31.81 mm to approximately 32.13 mm when the IUD is in the fully developed position. As those skilled in the art will appreciate, the length does not include the knot or cords that can accompany the IUD. The T-shaped IUD comprises an elongated body 204 having a proximal end 10 and a distal end 20. The elongated body 204 may include a coating such as a drug or time-release hormone. The elongated body can be formed from any suitable material, including but not limited to plastic or copper. At the distal end 20 of the IUD (i.e., the end positioned away from the physician's hand), arms 206a, 206b are secured to or integrally formed with elongated body 204. Arms 206a, 206b are configurable to fold up u or down d to minimize the IUD cross section so that the IUD can fit inside the sheath or inserter tube for insertion through the cervix and into the uterus. Furthermore, each or both of the arms 206a, 206b are configurable to include an enlarged or bulbous tip 208a, 208b, which may, for example, have a curved, spherical or semi-spherical shape. The tips 208a, 208b of the arms 206a, 206b can be formed so that the arms, when folded up and pushed together, form a smooth, rounded distal tip, for example, as shown in Figures 3B-3C and described below. At the proximal end of the IUD 10, the IUD may further include one or more strands 210a, 210b attached to the IUD. The cords are connectable to the IUD at connection point 211, for example, tied in a knot as illustrated.
[00055] Although the inserter is generally described herein with respect to a T-shaped IUD such as the IUD shown in Figure 2, it should be noted that the inserters of the present description are adaptable to facilitate insertion of other configurations of the IUD, as would be appreciated by a person skilled in the art. Furthermore, the insertion device operation and the IUD insertion procedures can include any number of steps that correspond to a desired IUD position. In addition to the features described below, the insertion devices of the present description include IUD position control features which can be advantageous for insertion of IUDs having a variety of configurations. For example, although the IUD insertion procedure described below refers to a three-phase procedure corresponding to three different IUD positions, the insertion device operating procedure may include less than three or more than three steps. Consequently, the insertion devices can include any number of position control features that correspond to the desired IUD positions. The inserter of the present description can be used with several 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®.
[00056] The insertion device described here is configurable to operate according to procedural steps which generally mimic commonly known procedures used for IUD insertion. However, the inserter of the present description includes improvements in device structure and operation. In another aspect of the devices described, the procedural steps for insertion of an IUD include: (i) procedures for preparing a pre-insertion insertion device, (ii) a first step of insertion of the IUD (also referred to herein as step 1 , position 1, or step 1), (iii) a second step of IUD insertion (also referred to herein as step 2, position 2, or step 2, (iv) a third step of IUD insertion (also referred to herein, as phase 3, position 3, or step 3), and (v) post-insertion procedures.
[00057] Pre-insertion insertion device preparation procedures may include loading an IUD, such as the IUD illustrated in Figure 2, into an insertion device, aligning the IUD in plane with a patient, positioning the IUD in a correct longitudinal position along the length of an insertion device sheath, and lock the IUD into position for insertion. Such pre-insertion inserter preparation procedures are described in further detail below.
[00058] Figures 3A-3D illustrate the positioning of an insertion device 300 during a first stage of IUD insertion in accordance with an aspect of the present description. Inserter 300 is sized and configured for placement within a uterus, having a tube length (or working length) of 15 cm to 25 cm, and a diameter of 3 mm to approximately 5 mm. A distal end 20 of sheath 332, which has a proximal end and a distal end and a lumen extending between the proximal end and the distal end, is advanced through a cervical channel (not shown) so that sheath 332 projects slightly to inside the uterus as illustrated in Figure 3A using a demonstrator representing human anatomy. The IUD 302 is not yet unfolded and remains within the sheath 332. The hands of the IUD 308a, 308b can be partially unfolded to create a rounded shape on the distal end 30 of the inserter 300, as shown in Figure 3B, while the body is elongated. 304 of the IUD remains within the 332 sheath. Alternatively, in aspects where the 332 inserter sheath or other aspect provides a rounded distal tip, the IUD arms 306a, 306b are encircled by the 332 sheath, as shown in the cross section taken by along lines BB in Figure 3B and shown in Figure 3C. Distal end 20 of sheath 332 is configurable so that it forms a rounded tip which can swell open when the IUD positioned within the sheath is advanced beyond its distal end (e.g., has a first diameter opening when the IUD is fully positioned within the sheath, and an opening of one second, larger in diameter when the IUD is advanced distally beyond the tip of the sheath).
[00059] Figure 3D shows another cross section taken along the DD lines in Figure 3B of inserter 300. As seen in this illustration when the IUD 302 is positioned fully inside the sheath 332, the distal tip 20 has an opening 331 with a diameter d1 that is smaller than the diameter d2 of the IUD 302. Figure 3E illustrates a view below the barrel of the device taken from view EE in Figure 3B of the inserter 300, during a first IUD insertion step of in accordance with an aspect of the present description. The opening 331 has a diameter d1 that is smaller than the diameter d2 of the sheath 332. The IUD 302 is rotatable r in the plane around the longitudinal axis x as shown in Figure 3D, so that the IUD arms or similar features of the IUD will be in line with the respective openings of the patient's fallopian tubes.
[00060] Figures 4A-4C show a cross section of the IUD 402 in combination with an insertion device 400 during the transition from a first stage (1) to a second stage (2) of IUD insertion, along the cross section DD of Figure 3B. As illustrated in Figure 4C the arms 406a, 406b of the IUD 402 have been advanced distally (i.e., toward the distal end 20) and out of the sheath 432, which has a proximal end and a distal end and an extending lumen. between the proximal end and the distal end, which allows arms 406a, 406b to extend radially away from a central geometric axis x. Figures 4D-4F illustrate the positioning of insertion device 400 during a second phase of IUD insertion. In stage 2, the IUD 402 is partially deployed from the sheath 432 as shown in Figure 4b.
[00061] Looking now at Figures 4D-4F, the IUD 402 is partially unfolded so that the elongated body 404 of the IUD 402 remains positioned within the sheath 432, and the arms 406a, 406b extend from the sheath 432 and unfold to extend to extend to outside the elongated body 404 of the IUD 402. As shown in Figure 4E, the insertion device 400 is extended distally into the uterus (not shown) until a flange 433 reaches a set distance from an outer orifice 422 of the cervix 420, and the IUD is partially deployed from the inserter sheath 432 into the uterus (not shown). A clinician operating the insertion device may, during use, maintain a position shown in Figure 4E for a period of time, eg 10-25 seconds, and more often 15 seconds, to ensure that the 406a IUD arms, 406b are fully unfolded or expanded to the desired position or configuration. Subsequently, as shown in Figure 4F, the inserter 400 is advanced distally until the flange 433 reaches the outer cervix orifice (not shown), whereby the IUD arms 406a, 406b contact the fundus 416 of the uterus. (not shown).
[00062] Figures 5A-5C illustrate the positioning of an IUD 502 during a third phase of an insertion procedure. As shown in Figures 5A-5B, the IUD 502 is fully deployed from the insertion device (not shown) into the uterus 514, and the cords of the IUD 510 extend from the uterus 514, through the cervix 520, and into the vagina 524. as shown in Figure 5B. Figure 5B provides a plan view showing a detailed illustration of the relevant female anatomy, including uterus 514, fundus 516, fallopian tube openings 518a, 518b, cervix 520, cervical canal 521, external orifice 522 of the cervix 520, and the inner orifice 523 of the cervix 520.
[00063] Upon completion of the IUD insertion phase, post-insertion procedures are performed, such as removing the insertion device sheath from the patient and trimming the IUD cords to an appropriate length for a specific patient.
[00064] The inserters of the present description demonstrate improved device structure and operating technique, as well as increases in ease of operability. The insertion devices of the present description are configured to reduce the pain and trauma suffered by patients during the IUD insertion procedure. Most women have a cervix which varies in opening diameter from approximately 1 to approximately 3 millimeters. The size and shape of the cervix varies widely with the patient's age, the patient's hormonal status, and whether the patient has given birth to a child through vaginal birth. However, the IUD and insertion device typically have a larger diameter than the diameter of the cervical canal, especially at the external orifice and internal orifice of the cervix or uterus. Such mismatch between the diameters of the cervix and the insertion device creates a resistive path for IUD insertion which can hinder proper IUD insertion and result in a traumatic insertion for the patient. The diameters of traditional IUDs and insertion devices are large compared to the typical human female 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, severe pain, and an adverse vasovagal response, which can result in fainting or seizures.
[00065] Pain during the IUD insertion procedure is reduced by the structure and operation of the insertion device, as well as the ease of operability of the insertion device. Traumatic insertion can result from difficulties in operating the IUD insertion tool, insertion device malfunction, improper IUD placement during insertion, operator error, and inherent design features of the insertion device itself. The insertion devices of the present description are configured to reduce drag and friction during the IUD insertion process. The insertion devices are configurable to operate smoothly, quickly, stably, easily, and in a highly controlled and consistent mode, thereby reducing trauma to the patient during IUD insertion and deployment.
[00066] The present description provides an insertion device structure and operation that control the position of the IUD during the various phases of the insertion procedure. Traditional insertion devices do not provide a reliable mechanism to position the IUD and maintain proper IUD placement throughout the insertion procedure. Holding the IUD in the proper location during multiple stages of insertion is important for proper and pain-free insertion. Improper IUD placement such as misalignment or premature or posterior IUD deployment can cause unsuccessful and painful insertion. The present description provides improved position control through the use of position control features to control both in-plane and longitudinal alignment of the IUD during the insertion procedure. In one aspect of the devices described, the insertion device further includes position control feedback or signal characteristics to provide verification and assurance of proper IUD placement. II. POSITION CONTROL & IUD ALIGNMENT
[00067] The inserters of this description are configurable to exhibit a high degree of control and accuracy of the position of an IUD during an IUD insertion procedure. It is important to control the placement and alignment of the IUD with a high degree of precision during the IUD insertion procedure. For example, in the IUD insertion procedure illustrated in Figures 3-5 and discussed above, it is important to control the longitudinal position of the IUD, and the alignment in the IUD plane, the cross section of the IUD and the insertion device sheath.
[00068] As discussed above, the IUD 302 is rotatable r in the plane around the longitudinal geometric axis x as shown in Figure 3D, so that the IUD arms or similar features of the IUD will be positioned in line with the respective tube openings the patient's fallopian tubes 518a, 518b, as shown in Figure 5B, to obtain an in-plane alignment. Generally speaking, when an IUD is in in-plane alignment the IUD is positioned flat, or substantially flat, within a plane defined by the openings of the fallopian tubes 518a, 518b and the cervical canal 521, such as the coronal plane shown xy in Figure 5B. The arms of the IUD 506a, 506b, or the similar functional characteristic for a non-T-shaped IUD, will be positioned close to the openings of the fallopian tubes 518a, 518b when the IUD is in place. The proximal end of the elongated body of IUD 504 is proximal to the inner hole 523 of the cervix, and the strands of the IUD 510 extend closer to the IUD 502 into the vagina 524.
[00069] In phase 1 of insertion, as shown in Figures 3A-3E, the IUD 302 is positioned within a delivery device 300 so that the IUD 302 will not deploy prematurely but will deploy readily during the transition to phase 2. The cross-section of a distal end 20 of the inserter 300 is configurable so that it has a minimum diameter along a longitudinal portion of the inserter that is inserted into a patient's cervix and uterus, and the distal tip 301 of the inserter 300 is further configurable to feature 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 damage 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 IUD 302 is preferably positioned within the uterus having an in-plane alignment such that the positioned IUD will be substantially in, for example, a coronal plane as discussed above. POSITION CONTROL CHARACTERISTICS
[00070] The present description describes insertion devices comprising one or more features for controlling a longitudinal position of an IUD through all the various stages of the IUD insertion procedure. The inserters are adaptable and configurable to include an IUD inserter comprising an elongated inner member and an elongated sheath at least partially surrounding or encircling the elongated inner member, wherein the inner member and sheath are configurable to engage in a translational movement relative to one another along the longitudinal geometric axis. IUD insertion devices can further accommodate a variety of IUD configurations.
[00071] The elongated sheath of the insertion device houses the IUD during the insertion procedure and has a narrow sheath tip cross-section at its distal end so that the distal end of the sheath and the IUD housed in it will mount through the cervix during insertion of the inserter into the uterus. In at least some configurations, the 1mm to 2mm distal end of the tube is tapered from its maximum diameter (eg 3-5mm) to a value at the distal portion that is approximately 50-90% of the diameter (eg , a diameter of approximately 2.4 mm to approximately 4.4 mm). The inserter sheath tip is configured to compress an IUD positioned within the sheath along the elongated or longitudinal axis of the IUD confining the IUD within a narrow sheath opening. In at least some configurations, the inserter sheath is an elongated member which is hollow, such as an elongated hollow cylinder or tube, along at least a portion of its longitudinal length. The elongated sheath of the inserter is additionally configurable to be flexible enough to allow the sheath to be moldable or conformable to each patient's unique anatomy, yet strong and rigid enough to prevent collapse or unwanted movement during the procedure. insertion. Suitable materials for the insertion device sheath include biocompatible materials such as plastic or thermoplastic polymer including, for example, polyethylene or polypropylene.
[00072] The elongated inner member mounts at least partially within the cavity or opening of the sheath, and thus, the elongated inner member is at least partially surrounded or surrounded by the sheath, whereby the inner member can slide into the sheath along of a longitudinal axis without unwanted friction. The elongated inner member can be a rod, sheath, or any elongated member capable of translating the IUD along a longitudinal axis during the IUD insertion procedure. The elongated inner member, or plunger, is typically configured so that it is flexible enough to allow the plunger to take the shape of the elongated sheath once molded or conformed to the individual patient's anatomy. Suitable materials for the insertion device sheath include biocompatible thermoplastic polymer materials such as polyethylene or polypropylene. In one aspect of the devices described, at least a portion of the plunger is hollow to provide a path for one or more strand components of the IUD to pass.
[00073] The translational movement of the elongated inner member and the inserter sheath relative to each other along a longitudinal geometric axis allows the translational movement of the IUD with respect to the inserter sheath and/or elongated inner member to the along the longitudinal axis. The IUD and inner member typically do not translate along the longitudinal axis relative to each other. In addition, an inserter sheath and IUD typically translate relative to each other along the longitudinal axis during the IUD insertion procedure, whereby the inserter sheath is pulled closer (backward) of the uterus and cervix while the IUD remains positioned inside the uterus.
[00074] As will be appreciated by those of skill in the art, the insertion devices are configurable so that the elongated inner member can be pushed or extended distally (toward the patient and away from the operator) to position the IUD either retracted or extended closer (away from the patient and towards the operator). Thus, for example, the sheath can be pulled back closer and/or the elongated inner member can be extended distally to position the IUD.
[00075] In some configurations, the plunger is configurable so that it remains stationary during the insertion procedure and only the sheath is retracted. In other respects, the sheath is configurable to remain stationary and only the plunger is advanced distally. In still other aspects, the insertion device includes one or more sheath and plunger position control features which allow movement of both the sheath and the plunger, either simultaneously or at different times and either the same distance or different distances. For example, in step 1, the insertion device is advanced distally through the cervical canal and into the uterus. In step 2, the position control feature pushes the plunger distally slightly to unfold the IUD arms. Optionally, the position control feature then moves both the plunger and sheath distally so that the arms of the IUD approach the fundus of the uterus (ie, the upper portion opposite the cervix). In step 3, either the sheath is retracted and the plunger is advanced distally, or the sheath is only retracted closer.
[00076] The inserters of the description are further adaptable and configurable to include a portable IUD inserter comprising an elongated inner member, an elongated sheath that at least partially surrounds or surrounds the elongated inner member, and at least one feature control which controls the translational movement of the elongated inner member and the elongated sheath relative to one another along a longitudinal axis. III. SLIDE CONTROLS
[00077] In one aspect of the inserters of the present description, as illustrated in Figures 6A-6C, the inserter 600 having a proximal end 10 and a distal end 20 comprises a portable inserter comprising a limb elongated inner (plunger) 634, an elongated sheath 632, an interface such as a user interface or handle 635, and a slide 642 for actuating or controlling the translational movement of the elongated sheath 632 and the elongated inner member 634 relative to each other along its longitudinal geometric axes. Inserter handle 635 provides a housing for inserter parts such as proximal end 10 of sheath 632, proximal end of plunger 634, and slide 642. Handle 635 is further configurable to allow an operator to engage handle 635 when operating inserter 600. Handle 635 is configurable to include an elongated guide (slit, channel, slide track or sliding window) 640. Elongated guide 640 is adaptable and configurable to provide a guide or channel (e.g., a U-shaped channel, or a channel that has a bottom surface, and two side walls) along which the slide 642 can move or slide during operation. Slide 642 is configurable so that it physically engages elongated sheath 632 and directly controls the longitudinal location and translational movement of sheath 632 in at least one of a proximal and distal direction relative to elongated inner member 634 and the IUD (not shown). In operation, an operator's finger, or, more preferably, the thumb, moves slide 642 along elongated guide 640.
[00078] The elongated slide and guide system is configurable to allow the user to control the positioning and IUD during the insertion procedure. As shown in Figure 6B, slide 642 is located in a distal starting position during step 1 of the insertion procedure. In step 2, the user moves slide 642 along elongated guide 640 to a second position (not shown). In step 3, the user moves slide 642 along elongated guide 640 to a third position (not shown). Typically, slide 640 is positioned in a distal position and then moved closer to steps 2 and 3.
[00079] As described above, preserving a smooth, rounded, and low-profile inserter tip as shown in Figures 3A-4A reduces pain and prevents premature deployment of the inserter IUD. Maintaining a proper IUD position and controlling the positions of the IUD, the elongated inserter sheath, and the elongated inner member of the inserter during the insertion process can also alleviate other problems that may arise during the insertion procedure, such as such as managing the IUD cords. In addition to the elongated slide and guide system described above, the inserters of the present description are further configurable to include one or more additional features to improve IUD position control.
[00080] In another aspect of the devices described, the slide, the elongated guide, and/or the housing are adaptable and configurable to include one or more position control features which can ensure that the slide is maintained in the proper location in each one of the stages of the insertion procedure, such as the positions shown in Figures 3-5. For example, as shown in Figure 6C (which shows the handle without the slide 642 positioned within the elongated guide 640) the position control features 641a, 641b, 641c help the user to control the slide position, thereby positioning the slide in a predefined location that corresponds to each procedure step. As illustrated in Figures 6C-D, position control features 641a, 641b, 641c are female indentations configured to mate with male protrusions on the slider (not shown). These position control features are holds that act as a mechanism that temporarily holds one part (the slide and its attachment) in one position relative to that of another (the handle), and can be released by applying a force to one of the parts. By precisely controlling the position of the sheath slide of the inserter, the sheath will be properly positioned relative to the IUD as the sheath slide controls the sheath. Position control features can be "soft stop" features which prevent or otherwise interrupt uniform sliding movement of the slide along the elongated guide.
[00081] In some configurations, soft motion control characteristics (for example, stop characteristics, position control characteristics, and motion control characteristics) are not based on direct physical contact between different control surfaces. components of the inserter as provided with the stop configuration. For example, the elongated guide soft stops 641a, 641b, 641c are adaptable and configurable to include a decrease in a width w of the elongated guide 640, or a decrease in tolerance between the elongated guide and the slide, whereby friction Increased exists between the sheath slide 642 and the housing 635 at different locations along the elongated guide 640 corresponding to a procedural stop or pause - e.g., step 1, 2, or 3 corresponding to the IUD positions shown in Figures 3A , 4C, and 5C, respectively. This configuration could be in place of the stop configuration described above. The position control features of the housing, elongated guide, and/or slide may include physical features such as stops, notches, grooves, protrusions, tabs, edges, flanges, flaps, doors, flexible members, contours, curves, shapes, etc. which are configurable to prevent slide movement at corresponding locations within the housing or elongate guide. Soft motion control features can, for at least some configurations, be advantageous over hard motion control features because soft motion control features can increase a user's control during operation. i. As will be appreciated by those skilled in the art, motion control features may also include "hard stop" features which include physical contact between the slide and the surface of other components of the inserter to prohibit further movement of the slide in an unwanted direction. Typically, hard stops include direct physical contact between two or more device components, whereby the hard stop prohibits further movement of each component beyond the hard stop point. For example, the inserter shown in Figure 6D includes a first hard motion control surface 641d (e.g., stop surface) at the distal end of the elongated guide 640 and a second hard motion control surface 641e at the proximal end of the elongated guide 640. In this configuration, step 1 of the insertion procedure can be defined by physical contact between the slide 642 and the first hard motion control surface 641d, and step 3 of the insertion procedure can be defined by physical contact between the slide (not shown) and the second motion control surface lasts 641e. Intermediate stops can be facilitated by using a 641b soft stop similar to the soft stop illustrated in Figure 6C. ii. When the stop position of a procedure phase involves a hard motion control characteristic (for example, stop characteristics, position control characteristics, and motion control characteristics), the user would be more likely to use a speed or excessive force when moving the slide. The hard motion control features could encourage the user to disregard the need for caution, precision, and delicacy, as the user will rely on the contact between the hard motion control surfaces to ensure that the procedural step is complete. The user would be more likely to use excessive force and forcefully knock the slide or other position control feature into contact with the hard motion control surface, which would result in disruptive movement of the entire inserter as a whole and cause pain for the patient or interrupting the insertion procedure. Unlike hard stops, the soft motion control surfaces of this description encourage the user to exercise care, precision, and delicacy during the insertion procedure. In addition, certain soft stop control features of the features of the present description can be sensed by touch by the user's thumb or finger, providing a sensory signal to the user that corresponds to procedural steps or stopping points. For example, with the device shown in Figure 6D, the user would not feel the hard motion control surfaces 641d, 641e directly in contact with the user's thumb.
[00082] However, as explained in more detail below referring to the device shown in Figures 8A-8F, the device has a proximal end 10, a distal end 20, an upper surface 30, a lower surface 40, and at least one surface side 50. When using the device of the description, the user can feel the housing surfaces 844a, 844b, which are force limiting characteristics, in direct contact with the user's thumb in steps 1 and 3, respectively, as shown in Figures 8D and 8F. Although the force limiting features 844a, 844b of the inserter 800 prevent movement of the slide 842 past the housing surface 844a, 844b, the force limiting features do not require a contact between the multiple inserter components, however example, between the slides 842 and the housing surfaces 844a, 844b. Additional benefits of soft motion control features will be recognized by persons skilled in the art. For example, the soft motion control features can minimize the sharp edges of the inserter and prevent the inserter from pinching the user.
[00083] The position control features of the present description, such as the slide features, the elongated guide features, and/or housing features are soft motion control features which provide a soft stop during operation of the device. of insertion and merely prevent or interrupt the sliding movement of the slide along the elongated guide, thereby contributing to a smooth, uninterrupted sliding movement. However, features may also include "hard stop" features which prohibit further movement of the slide in a desired direction.
[00084] Alternatively or in addition, the elongated housing or guide may be adapted and configured to include one or more sensory signal features or indicators which provide sensory feedback to the user that the slide is in the proper position corresponding to one or more stages of the insertion procedure. Indicating characteristics such as sensory signal characteristics are discussed in more detail below. For example, the sensory signal characteristics of the inserter may include a visual indicator such as a visual alignment feature, an auditory indicator such as a click or other noise heard by the inserter operator, and/or an indicator feature. tangible which can be felt by the operator, such as a tangible forefinger felt by the operator's finger or thumb.
[00085] The slider may be a sheath slider attached to the elongated sheath to retract the sheath to position the IUD. Alternatively, or in addition, the slide may be a plunger slide which is secured to the plunger and pushes the plunger distally to position the IUD. The slide may include any suitable structure which allows the user to move the slide. For example, the slide may include a button, tab, slit, or any suitable interface for moving the slide and the attached sheath or plunger in the proper direction. Preferably, the slide slides smoothly along the elongate guide, although it is also preferred that some friction exists between the slide and the elongate guide so that the slide will not slide as easily along the elongate guide. Some friction between these components is preferred so that the user has control over the slide movement and the slide will not easily or unintentionally slide along the elongated guide without a force applied by the user - i.e. the slide will not move within the elongated guide due to mere gravitational force or external movement. As will be understood by those skilled in the art, the tolerance or spacing between inserter components can be adjusted to provide the appropriate amount of frictional force between the components. Such frictional force or resistance exists unanimously or substantially between the slide and the housing or the elongated guide rather than between the sheath and the plunger.
[00086] Additional elongated guide configurations may be incorporated into any of the inserters of the present description. For example, the housing or handle described above is adaptable and configurable to have a variety of elongated guide configurations as shown in Figures 7A-7C. For example, for a curved elongated guide 740, as shown in the examples shown in the figures. In Figures 7A-7C, the one or more curves c1, c2, c3, are configurable to correspond to a procedural step such as a stop or pause, whereby the curves provide a soft stop or increased resistance to slide movement 742 within the elongated guide 740 or channel. The increased friction between the elongate guide 740 and the slide 742 at the one or more curves c1, c2, c3 of the elongate guide 740 decreases the movement of the slide 742, thereby creating a soft stop at one or more curved locations along the length. of the elongated guide. Curves c1, c2, c3 on the elongated guide 740 are disposed along the longitudinal axis x of the inserter handle, whereby the slide moves from side to side as it slides along the elongated guide. As will be appreciated by those skilled in the art, in some configurations both side-to-side movement and longitudinal movement are obtainable by the slide. In still other embodiments (not shown), the elongated guide curves are disposed at different depths within the handle, whereby the slide moves up and down as it slides along the elongated guide. As will be understood by persons skilled in the art, the elongated guide may be disposed along any suitable geometric axis of the inserter. For example, the elongated guide can be arranged along the geometric x longitudinal axis of the inserter or along a geometric axis perpendicular thereto. Furthermore, as will be understood by those of skill in the art, the elongated guide may have any suitable shape not limited to the straight or curved paths shown in the Figures and described herein.
[00087] Additional aspects for the slide or other position control features are discussed in more detail below. For example, the inserter is configurable to include multiple sliders for controlling multiple device components. For example, the inserter can have a bilateral configuration so that the slide or other control features can be operated from the top or bottom side of the device housing, thereby allowing for left-hand or right-hand control while still providing the benefits of the improved inserter of the present description. The insertion device is further adaptable to include additional control features built into the slide itself to allow additional functionality beyond sheath or plunger movement control. For example, the insertion device may include IUD cord control features and signal features for indicating procedural steps or IUD location.
[00088] As shown in the configuration of the inserter illustrated in Figures 8A-8F, the inserter 800 of the present description includes an elongated sheath 832, a sheath flange 833, an elongated inner member or plunger 834, a slide 842, a housing 835 including a housing top piece or top surface 835a and a housing bottom piece or bottom surface 835b, and an elongated guide 840. Slide 842 may be integrally formed of a sheath slide, e.g. so that it operates in a unified mode or is constructed or constructable in a single piece, attached to the elongated sheath 832. However, as will be understood by persons skilled in the art, the slide can be attached to the plunger or integrally formed with the plunger without moving away from it. the scope of the description. Inserter 800 includes control features to control the relative positions of sheath 832, plunger 834, and IUD (not shown in Figure 8). Such position control features may include slide features, elongated guide features, and/or housing features, including, but not limited to, any of the features described above. Slide 842 and housing 835 or elongate guide 840 each include at least one alignment surface, which surfaces become aligned when the slide is positioned at a location that corresponds to the appropriate slide position that corresponds to a defined step. in the IUD insertion procedure. The slide and elongated housing/guide may further be adapted and configured to include multiple alignment surfaces, wherein different slide and/or elongated housing/guide surfaces are differently aligned during different phases of the IUD insertion procedure - for example, at different locations along the elongated guide, at different stages of the insertion procedure, or at different times during the insertion procedure.
[00089] Looking at Figure 8C, sheath 832 couples slide 842 to the proximal end 10 of the sheath and to the distal end 20 of the slide mechanism. Slide 842 as shown has an upper surface 842a, a lower surface 842b, and two side surfaces 842c, 842d. The upper surface 842a is further characterized by an indentation that has a length L1 and sized sufficiently to communicate with the user's finger during use. The indentation is further characterized by a first side surface 842e, a second side surface 842f which faces the first side surface 842e, and a bottom surface 842g. Plunger 834 couples housing 835 to proximal end 10 of plunger 834 and to the distal end of housing 835. Plunger 834 is an elongated shaft having a first diameter d1 along a distal section s1, a second diameter d2 along a a penultimate section s2, different from the first diameter d1, and a third diameter d3 along a proximal section s3, which is larger than the second diameter and can be the same as the first diameter. Housing 835, as shown, has an upper surface 843a, a lower surface 843b, and two side surfaces 843c, 843d. The upper surface 843a is further characterized by an indentation that has a length L2 greater than the length L1 of the slide. The indentation or channel is defined by a first side surface 842a, a second side surface 842b which faces the first side surface 842a, and a bottom surface 842c. As shown in the configuration of Figure 8, the width of the slide 842 is such that it mounts within an elongated channel 840 of the housing 835.
[00090] In the configuration illustrated in Figures 8A-F, the slide 842 includes at least a first slide surface 842e and at least a second slide surface 842f, and the housing 835 includes at least a first surface 844a and at least one second surface surface 44b. Figures 8D-8F illustrate these position control features of slide 842 and housing 835 during different phases of an IUD insertion procedure. Figure 8D corresponds to step 1, Figure 8E corresponds to step 2, and Figure 8F corresponds to step 3 of the insertion procedure described above. As slide 842 is moved along an x longitudinal axis of inserter 800 during the various stages of IUD insertion, surfaces 842e, 842f of slide 842 are configured to align with one of housing surfaces 844a, 844b during at least one step of the procedure. In step 1, the first slide surface 842e is aligned with the first housing surface 844a, while the second slide surface 842f and the second housing surface 844b are not aligned. In step 3, second slide surface 842f is aligned with second housing surface 844b, but first slide surface 842e and first housing surface 844a are not aligned. Although only two alignment points are shown in Figures 8D-8F, fewer or more than two alignment points are anticipated by the present description. For example, the inserter may further include additional slide and/or housing surfaces which are aligned in step 2 of the insertion procedure. The lower surface 842g of the slide 842 and the lower surface 844c of the housing are configurable so that the depths d4 (the depth set between 835a and 844c), d5 (the depth set between 842a and 842g) relative to the top surfaces 835a, 842a of housing 835 and slide 842 are the same or similar.
[00091] When the respective features (eg surfaces 842, 844) are aligned during use, such alignment indicates to the user that the IUD is in the proper location that corresponds to the corresponding procedure step. Position control features can be configured so that the features are force limiting (or force absorbing) characteristics which restrict or prohibit further movement of the slide beyond designated locations on the elongated guide. Features are also configurable to prevent the user from applying excessive force to the slide, which could interfere with IUD placement or even damage the insertion device.
[00092] As shown in Figures 9A-9B, the width w of the sheath slide 942 and/or the elongated guide 940 is sufficiently narrow so that the user's finger or thumb can control and move the slide 942 along the elongated guide. 940 without the ability to move slide 942 beyond the force limiting characteristics on handle 935 or elongate guide 940. For example, in one aspect, elongate guide 940, slide 942, and slide surfaces 942a, 942b each one has a width which prevents the user from moving the slide 942 beyond the force limiting characteristics 944a, 944b of the grip housing 935. This limited width prevents the user from moving the slide beyond the alignment points.
[00093] Force limiting features improves IUD position control by preventing the user from moving the IUD out of the proper position. For example, in step 1 corresponding to Figure 8D and Figures 3A-3D, the force limiting feature 844a prevents the user applied force on the slide from moving the slide past the force limiting feature 844a. As the user's thumb cannot fit through the elongated guide beyond the force limiting feature 844a, the user's thumb encounters the force limiting feature 844a and the slide 842 will not move distally. As shown in Figures 9A-9B, the user's thumb is prevented from moving beyond the force limiting characteristics 944a and 944b due to the narrow width w of the slide 942 and the elongated guide 940. Preferably the width of the elongated guide 940 or the sledge 942 (or the combined width of multiple sledges) is 19 mm (0.75 inch) or less, 17.8 mm (0.7 inch) or less, 12.7 mm (0.5 inch) or less, 8 .9 mm (0.35 inch) or less, or 6.3 mm (0.25 inch) or less.
[00094] Excessive force applied to the slide by the user will be completely transferred to or absorbed by the stationary force limiting feature. As an additional benefit, force limiting features such as the force limiting features 844a and 844b prevent unwanted movement of the entire insertion device as a whole during the insertion procedure. As mentioned above, the alignment or coincidence of the slide and housing features can provide a signal to the user which indicates that the IUD is in the proper location that corresponds to the corresponding procedural step.
[00095] As will be appreciated by those skilled in the art, additional features and mechanisms in addition to the alignment surfaces discussed above can be used for position control and are provided for in the present description. Control features may include additional or different features, as will be understood by a person skilled in the art. Such slide, housing, and/or elongated guide position control features may include physical attributes such as shapes, distinctive physical features, angles, contour patterns, colors, sizes, or visual symbols, which assist the user in precisely controlling position the IUD through the entire insertion procedure. For example, features could be misaligned when defined procedure steps occur and aligned at other times - that is, misaligned in defined procedure steps 1, 2, and/or 3, and aligned in times between said steps. Mechanical characteristics could also be configured to coincide in a way other than by surface alignment or other physical characteristics. In certain aspects, when a defined procedural step is achieved such that a slide is in the appropriate corresponding position, an inserter may display a visual signal to the user which appears only when the slide is in the proper location corresponding to such. procedure step. For example, the inserter could display a visual indicator symbol such as an image, word, character, number, pattern, color change, etc., whenever the slide location corresponds with a procedural step (or whenever the slide location does not correspond to a procedure step). The indicating features of the inserter of the present description are described in more detail below.
[00096] The present devices may be configured to include a portable inserter adapted and configured to insert an IUD or IUS comprising an elongated inner member, an elongated sheath that at least partially surrounds or surrounds the elongated inner member, and one or more control features to control various features of the insertion device. The control features are further adapted and configurable to include at least one control feature which controls the translational movement of the elongated sheath and the elongated inner member relative to each other along the longitudinal axis, and at least one control feature to control one or more IUD cord components during the insertion and/or post-insertion procedure. Bead control features, mechanisms, and methods of the present description are discussed in more detail below. As will be appreciated by those skilled in the art, any such features, mechanisms, and bead control methods can be used in combination with the various inserter designs discussed herein.
[00097] In one aspect of the inserter of the present description, as illustrated by the example in Figures 10A-10F, the inserter 1000 having a proximal end 10 and a distal end 20 comprises a portable inserter comprising a limb elongated inner or plunger 1034, an elongated sheath 1032, a handle or housing 1035, a sheath slider 1042 that projects or extends from an upper and/or lower surface of the housing 1035 and adapted and configured to control the translational movement of the elongated sheath 1032 and the inner member elongated relative to one another along their longitudinal axes in one or more of a proximal and/or distal direction, and at least one strand control feature for controlling one or more strands attached to the IUD (shown above and described with reference to Figure 2). A lanyard control feature can include, for example, a lanyard control slide 1046, as shown in Figures 10A-10F. As explained in more detail below, the 1046 Lanyard Control Slide is adaptable and configurable to control the attachment of the lanyards, for example, allowing for a locking and unlocking of one or more strands attached to the IUD.
[00098] Inserter housing 1035 provides a housing for the proximal end of inserter parts such as sheath 1032, plunger 1034, and slide 1042. In addition, housing 1035 forms a handle configured for a operator hold the insertion device during use. Housing 1035 includes one or more elongate slide windows or guides 1040a, 1040b which allow a user to access slides 1042, 1046. First elongate guide 1040a provides a guide along which sheath control slide 1042 can slide or slide. move during operation. A second elongated guide 1040b provides a guide along which the lanyard control slide 1046 can slide during operation. Slider 1042 may be a sheath slider which is physically attached to sheath 1032 and is adapted and configured to control the longitudinal location and translational movement of sheath 1032 relative to inner member 1034 and the IUD. In an insertion procedure, the operator's thumb is used to move the slides 1042, 1046 along their respective elongated guides 1040a, 1040b which are positioned adjacent to each other and can be partially or completely overlapped to control the elongated sheath 1032 and the IUD cords (not shown in Figure 10), respectively.
[00099] As can be seen in Figure 10B, the inserter 1000 includes a bilateral configuration, in which the side-by-side hem control and bead control slides 1042, 1046 are accessible or from the top (top) surface or bottom (bottom) of housing / handle 1035. A bilateral configuration of runners 1042, 1046 allows both left and right hand users to operate the inserter in the same mode. Sheath 1032 comprises a flexible yet rigid material which is formable or conformable to each patient's unique anatomy. Inserter 1000 is further configurable to include one or more force limiting features 1044a, 1044b adapted and configured to prevent the user from applying excessive force to slides 1042, 1046. The one or more force limiting features 1044a, 1044b can be configured so that features extend each or both of above and below each or both of the upper and lower surface of the housing. Force limiting features 1044a, 1044b may also be formed integrally with housing 1035, as shown in Figures 10A-10B. In at least some configurations, at least one of said force-limiting features functions as a soft stop rather than a hard stop, whereby the force applied by the user is limited by the force-limiting feature without requiring a contact between the inserter components or inserter component surfaces. Rather, the force limiting feature limits the user-applied force applicable to one or more slides by preventing or prohibiting the user's finger from moving the slide beyond a certain point along the longitudinal axis. For example, as shown in Figure 10C, inserter 1000 includes a hem control slide 1042 having a first surface 1042a and a second surface 1042b, a cord control slide 1046 having at least a first surface 1046a and a second surface 1046b, and a housing 1025 having a first surface 1044a and a second surface 1044b. Housing 1035 includes at least one force limiting feature that corresponds to housing surfaces 1044a, 1044b.
[000100] As will be appreciated by those of skill in the art, the force limiting feature prevents the slide from continuing movement in a distal (forward) direction when the force limiting feature(s) are engaged. Without the force limiting feature, the slide would continue to move distally (forward).
[000101] As shown in Figures 10A-10F, a bilaterally operative inserter 1000 may further be configured to comprise a housing 1035 which includes a further garage, opening, cavity, or hole features which surround or cover at least one portion of one or more slides 1042, 1046 in one or more positions during certain phases of the insertion procedure. For example, as shown in Figures 10D-E, the distal and proximal force limiting features of housing 1035 each comprise a cavity 1045a, 1045b. In step 1 of the insertion procedure, sheath slide 1042 is located within first cavity 1045a, near the distal end of elongated sheath guide 1040a. In step 3 of the insertion procedure, both sheath slide 1042 and bead control slide 1046 are located within second cavity 1045b, near the proximal end of elongated guides 1040a, 1040b. Inserter 1000 further comprises one or more alignment features, such as surface features of the one or more slides and elongated housing or guides. As shown in Figure 10D, the housing includes a first surface 1044a at the distal end of the elongated sheath guide 1040a and a second surface 1044b at the proximal end of the elongate sheath guide. Sheath slide 1042 includes a first surface 1042a and a second surface 1042b. As shown in Figures 10E-F, bead control slide 1046 includes a first surface 1046a and a second surface 1046b. As mentioned above, the alignment or coincidence of the slide and housing features can provide a signal to the user which indicates that the IUD is in the proper location that corresponds to the corresponding procedural step. For example, the alignment / position control surfaces 1044a and 1042b are aligned in step 1, as shown in Figure 10D. Surfaces 1042a and 1046a are aligned in step 2, as shown in Figure 10E. Surfaces 1042a, 1046a, and 1044b are aligned in step 3, as shown in Figure 10F. As described above, the force limiting characteristics and alignment characteristics are soft motion control characteristics that do not require physical contact between the inserter features or components. Such smooth motion control feature prevents unwanted inserter movement during the insertion procedure and promotes smooth user movements without interruption caused by inserter components contacting each other.
[000102] As shown in Figures 10C-10F, the alignment of position control features or alignment surfaces corresponds to defined procedure steps and corresponding IUD positions. Furthermore, the alignment of these features provides a force limiting mechanism to prevent further slide movement caused by the force applied by the user. As shown in Figure 10D, which corresponds to the configuration of inserter 1000 during step 1 of the insertion procedure, the sheath slider is in the full distal position along the longitudinal axis of the elongated guide. The first surface 1042a of the sheath slider is aligned with the first surface 1044a of the housing, whereby the user's finger can simultaneously contact both the aligned surfaces 1042a and 1044a. The first surface 1044a of the housing is a force limiting feature, whereby the user's fingers will touch the first surface 1044a of the housing, and the user is prevented from sliding the sheath slide 1042 beyond the force limiting feature 1044a . Preferably, the combined width of both slides is narrow enough to prevent the user's finger from entering any of the cavities 1045a, 1045b.
[000103] As shown in Figure 10E, which corresponds to the insertion device configuration during step 2 of the insertion procedure, the sheath slide and the bead control slide are each at an average position along the longitudinal axis of the elongated guide. During steps 1 and 2, the bead control slide may be disposed on a separate elongated guide 1040b, and the bead control slide may be positioned in the full distal position of the elongate guide 1040b. As the user slides sheath slide 1042 backward along the elongated guide, sheath slide 1042 approaches bead control slide 1046. Eventually, second surfaces 1042a of sheath slide 1042 and first surface 1046a of slide control cord are aligned, meaning the IUD is in the proper position that corresponds to step 2.
[000104] As shown in Figure 10F, which corresponds to the configuration of inserter 1000 during step 3 of the insertion procedure, sheath slide 1042 and bead control slide 1044 are in full proximal position along the geometric axis lengthwise of the elongated guides 1040a, 1040b. The second surface 1042b of the hem slide is aligned with the first surface 1048a of the bead control, and the user simultaneously slides both the hem slide and the bead control slide 1048 backward toward the second surface 1044a of the housing. When reaching step 3 of the insertion procedure, the user's finger contacts both the aligned surfaces 1042b and 1046a, as well as the second surface 1044b of the housing. The second surface 1044b of the housing is force limiting as the user's finger touches the second surface 1044b of the housing and the user is thereby prevented from sliding the first sheath slide surface 1042a and the first control slide surface lanyard 1046a in addition to the force limiting feature 1044b.
[000105] Sheath Slide 1042 and Lanyard Control Slide 1046 are configurable so that they can but do not need to be physically secured together. Furthermore, sheath slide 1042 and bead control slide 1046 are configurable so that they can translate or slide freely and independently of each other. The combined width of sheath slide 1042 and cord control slide 1046 is of sufficient width to allow a user's finger or thumb to control and move the slides along their respective elongated guides 1040a, 1040b. In at least some configurations, control and movement of the slides are performed simultaneously. Housing 1035 includes one or more garage, cavity, or opening which is configured to surround or cover at least a portion of one or more slides. For example, as shown in Figure 10C, the force limiting features 1044a and 1044b of housing 1035 each comprise a cavity 1045a, 1045b. In step 1 of the insertion procedure, sheath slide 1042 is at least partially positionable within first cavity 1045a during at least part of the procedure, near the distal end of the elongated guide. In step 3 of the insertion procedure, sheath slide 1042 and bead control slide 1046 are both at least partially positionable within second cavity 1045b, near the proximal end 10 of elongated guides 1040a, 1040b. As described above, the force limiting characteristics of the inserter 1000 can be soft motion control features which do not require physical contact between the inserter features. Such smooth motion control feature prevents unwanted movement of the inserter during the insertion procedure and promotes smooth user movements without interruption caused by inserter components contacting each other. Furthermore, the alignment or coincidence of the slide and housing features can provide a signal to the user which indicates that the IUD is in the proper location that corresponds to the corresponding procedural step.
[000106] As shown in Figure 11, the distal (front) limit of the sheath slider movement is configurable so that the distal end 20 of the elongated sheath control guide 1140, and the closest limit of the control slider movement of hem 1142 is defined by the proximal end 10 of the elongated hem control guide 1140. In addition to the elongate hem control guide 1140, the inserter 1100 further comprises a cord control slide 1146 which is adaptable and configurable to move. within the elongated guide 1140. The cord control slide 1146 is configured so that it has two protrusions 1146a, 1146b that extend above the upper surface 30 of the handle 1135. A channel 1136c is formed in the cord control slide 1146 between them. two lumps 1146a, 1146b. When the user slides hem control slide 1142 closer to the position where the user's thumb contacts both hem control slide 1142 and cord control slide 1146, hem control slide 1142 is sized by so that it can slide between the channel 1136c formed in the bead control slide 1146. When the sheath control slide 1142 and the bead control slide 1146 are both advanced in the distal direction 20, the sheath control slide mounts inward of the cord control slide channel 1146 so that the two slides create a single profile extending from the housing 1135. Furthermore, the alignment of both slides sends a feedback to the user that the sheath control slide is in position suitable for step 2. Feedback can be tactile, visual, or audible. When the user slides sheath control slide 1142 and cord control slide 1146 simultaneously during the transition from step 2 to step 3 of the insertion procedure, both slides 1142, 1146 contact the distal end of the elongated guide 1140, thereby prohibiting the user from further movement of the slides in the distal direction. Distal movement of the sheath slide 1142 is also prevented as the sheath control slide 1142 and the cord control slide 1146 are moved simultaneously by the user. This mechanism sends a return to the user, indicating that step 3 of the insert procedure has been performed.
[000107] In another example, the insertion device includes multiple sheath slides or multiple bead control slides. Thus, for example, strand control slide 1146 may be formed of two distinct sledges 1146b, 1146c which are configured to operate independently and each slide controls one of the two strands over the IUD device.
[000108] In yet another aspect, as shown in Figures 12A-12B, the inserter 1200 which has an elongated sheath 1232 and a handle 1235, includes a sheath slide 1242 and a bead control slide 1246 at the handle 1235 As in the configuration shown in Figures 10A-10F, sheath slide 1242 slides in a proximal 10 and distal 20 direction along a path defined by a first elongated guide 1240a, and the strand control slide 1246 is movable along of a path defined by a second elongated guide 1240b. In this regard, the distal and closer ranges of motion for the slides 1242, 1246 may include elongated guide features such as the hard motion control surfaces 1241a, 1241b, 1241c, 1241d, rather than the illustrated inserter cavities 1000 in Figures 10A-10F. The distal movement limit of sheath slide 1242 is the hard movement control feature 1241a of the elongated guide 1240a, and the closest movement limit of the sheath slide 1242 is the hard movement control feature 1241b of the elongated guide 1240a. The distal movement limit of the bead control slide 1246 is the 1241c hard movement control characteristic of the elongated guide 1240b, and the closest movement limit of the bead control slide is the 1241d hard movement control characteristic of the elongated guide 1240b.
[000109] In step 1 of the insertion procedure (position not shown), sheath slide 1242 is in the distal position on the hard motion control feature 1241a of the elongated guide 1240a, and the bead control slide 1246 is in the distal position in the hard motion control feature 1241c of the elongated guide 1240b. In step 2 of the insertion procedure (position not shown), sheath slide 1242 is in a median position, positioned somewhere along the length of the elongated guide with cord control slide 1246 which is in the full distal position. of the hard motion control feature 1241c of the elongated guide 1240b. In step 3 of the insertion procedure (position not shown), sheath slide 1242 and bead control slide 1246 are aligned and located on proximal hard motion control feature 1241d of elongated guide 1240b. Although the closest limit of motion for sheath slide 1242 is configured as the proximal hard motion control feature 1241b of elongated sheath control guide 1240a, the insertion procedure is complete at step 3 when sheath slide 1242 is aligned with the proximal 1241d hard motion control feature of the elongated guide 1240b. A hollow area, indentation, slit or optional split 1248 may be provided on a proximal surface of cuff 1235 into which one or more strands may be secured.
[000110] As will be understood by persons skilled in the art, the inserters of the present description may include any suitable combination of position control features, including, but not limited to hard motion control features, soft motion control features , force limiting characteristics, cavities, or the like. For the sake of clarity and brevity, all possible combinations of such features are not discussed in detail here, but such combinations are included in the inserter of the present description.
[000111] The inserters of the description are also configurable to include an IUD inserter further comprising an elongated inner member, an elongated sheath at least partially surrounding or surrounding the elongated inner member, and one or more control features to control various features of the insertion device. Control features include, but are not limited to, at least one control feature which controls the translational movement of the elongated sheath and the elongated inner member relative to each other along the longitudinal axis in one or both of a direction. proximal and distal, and at least one control feature to control one or more strands attached to the IUD during the insertion and/or post-insertion procedure. The sheath slide and the bead control slide are configured so that the slides have a telescopic configuration. The strand control features, mechanisms and methods of the present description are discussed in more detail below. As will be appreciated by those skilled in the art, such strand control features, mechanisms and methods can be used in combination with the various inserter configurations discussed herein.
[000112] As illustrated by the example in Figures 13A-13B, the inserter 1300 comprises an elongated sheath 1332, an elongated inner member or plunger (not shown), a handle or housing 1335, at least one elongated guide, a first slide 1342 to control the translational movement of the elongated sheath 1332 and the elongated inner member relative to one another along their longitudinal geometric axes, and a strand control slide 1346 to control one or more strands attached to the IUD. The lanyard control feature may include a lanyard control slide 1346, as shown in Figures 13A-13B. As explained in more detail below, the 1346 lanyard control slide can control the locking and unlocking of one or more strands attached to the IUD. Inserter housing 1335 is adaptable and configurable to provide a housing for inserter parts such as sheath 1332, plunger, and slides 1342, 1346, and provides a handle for the operator to hold the inserter. during operation. Housing 1335 is further adaptable and configurable to include a slide window or elongated guide which allows the user to access slides 1342, 1346. The elongated guide can be configured as illustrated in Figures 13A-B to include multiple elongated guides 1340a, 1340b which provide a guide 1340 along which runners 1342, 1346 can slide during operation. As will be appreciated by those skilled in the art the movement of the slides along the one or more elongated guides can be one or more concurrent or independent at any given time during the procedure. As illustrated, slide 1342 is a sheath slide which is secured to sheath 1332 and directly controls the longitudinal location and translational movement of sheath 1332 relative to the elongated inner member and the IUD. Slide 1346 is a bead control slide (for example, a bead release or bead release slide). In an insertion procedure, the operator's thumb is used to move both sliders 1342, 1346 closer and distally along respective elongated guides 1340a, 1340b to control sheath 1332 and IUD cords, respectively. As can be seen in Figure 13B , inserter 1300 is configurable to include a bilateral configuration, wherein slides 1342, 1346 are accessible either from the top 30 (top) or bottom 40 (bottom) face or surface of the handle. 1335. Furthermore, the telescopic slide configuration allows for left-hand or right-hand user operation without the need for a two-way configuration with slide control features on both the top and bottom of the handle/housing.
[000113] As illustrated in Figures 13A-B, sheath slide 1342 and bead control slide 1346 each slide along the elongated guide along a longitudinal axis in a proximal or distal direction. At the distal end of the guide is a housing with a cavity 1345 into which at least a portion of the slide can be advanced. Slides 1342, 1346 have a telescopic configuration whereby at least one slide slides within or across at least one other slide along the longitudinal axis. As will be appreciated by those of skill in the art, although sheath 1342 slides through 1346 bead control slide 1346 in the configuration shown in Figures 13A-13B, the description also includes designs where 1346 bead control slide 1346 slides in or through of the 1342 sheath slide.
[000114] In alternative embodiments, a first slide may include a plunger slide instead of a sheath slide. The telescopic configuration of the slides allows for a more functional, compact, and reduced-size insertion device. Additionally, this configuration can help avoid user confusion as the slides move along the same path on the elongated guide. As with the previous example, an optional hollow area, indentation, slot or optional split 1348 may be provided on a proximal surface of the handle 1335 within which one or more strands may be secured.
[000115] Inserter 1400 of Figures 14A-14B is similar to inserter 1300 of Figures 13A-13B, but inserter 1400 is further configured to comprise a first cavity 1445a and a second cavity 1445b at handle 1435 During step 3 of the insertion procedure, sheath slide 1442 and bead control slide 1446 are in full proximal position 10 along the longitudinal axis of elongated guide 1440, and at least partially surrounded by proximal cavity 1445b. Additional visual indication features 1460, 1460', 1460" are shown. Visual indication features may be provided on elongated sheath 1432, handle 1435, or both. Numbers 1, 2, and 3 on device components insertion provides a visual indication to the user of the proper 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 way including, but not limited to, printing, recording , molding, notching, etc. Furthermore, the visual indicators can be positioned so that they are only visible during certain aspects of the procedure, and not visible during other aspects of the procedure.
[000116] As with other configurations discussed above, the alignment of certain features or control surfaces is configurable to match a defined procedure step and corresponding IUD position, for example, as shown in Figures 15A-15C. As shown in Figure 15A the inserter 1500 is shown as it would be configured during step 1 of the insertion procedure with the sheath slide 1542 in a full distal position 20 along the longitudinal axis of the elongated guide 1540. As shown in Figure 15B, which shows inserter 1500 as it would be configured during step 2 of the insertion procedure, and sheath slide 1542 and bead control slide 1546 are each at a mid or intermediate position with respect to a proximal end and distal end of the elongated guide 1540 along the longitudinal axis of the elongated guide, at a location between the distal and proximal ends of the elongated guide. As the user slides sheath slide 1542 closer along elongated guide 1540 transitioning from step 1 to step 2, sheath slide 1542 approaches bead control slide 1546 and slides under or through a cavity on the 1546 lanyard control slide in a telescopic mode.
[000117] As shown in Figure 15B, a surface of sheath slide 1542 aligns with a surface of bead control slide 1546 to form a smooth interface where the user's thumb meets both slides simultaneously, or substantially simultaneously. As shown in Figure 15B, in step 2, a first sheath slide surface 1542a and a first strand control slide surface 1546a are aligned, meaning that the IUD is in an appropriate position that corresponds to step 2. In step 3, as illustrated in Figure 15C, which corresponds to the configuration of inserter 1500 during step 3 of the insertion procedure, the alignment of the first sheath control slide surface 1542a and the first strand control slide surface 1546a allows the user to simultaneously move both slides in sync from step 2 to step 3. As shown in Figure 15C, corresponding to the inserter configuration during step 3 of the insertion procedure, the sheath control slide 1542 and the bead control slide 1546 are at a proximal position along the longitudinal axis of the elongated guide 1540. Nearby, a second hem control slide surface 1542b abuts a proximal elongated guide surface 1540b.
[000118] As discussed above, the inserters of the present description may include one or more slides such as a cord control slide to control the cord release feature and a sheath or plunger slide to control the translational movement of the sheath elongated and the inner member elongated relative to each other along their longitudinal geometric axes. As discussed above, the inserters may include one or more elongated guides on which the slides slide along the longitudinal axis of the inserter. In the above configurations a simple elongated slide and guide configuration was discussed for the sake of simplicity and brevity. In the above configurations, such as those shown in Figures 6, 8, and 10-15, the slide movement can cause simple, direct translational movement of the corresponding inserter components - for example, the sheath slide can be directly attached in the hem, whereby when the hem slider is moved back by a given distance, the hem also moves back by the same distance. As will be understood by those skilled in the art, additional operating mechanisms for the control features are provided by the inserter of the present description. The inserters of the present description may include any number of a variety of different operating mechanisms for transforming user input movement into a translational or rotational movement of the inserter components, such as those mechanisms available and known to those skilled in the art. technique. For example, the inserters can include a crank system, a piston system, a rotary system, an oscillating lever system, a ratchet system, a rack and pinion system, a gear system, a hydraulic system, a spring system, a Geneva mechanism system, or the like, as well as combinations of any such systems.
[000119] In a general class of configurations, as shown in Figures 16A-16C, the inserter includes a slide 1642 positioned within an elongated guide 1640 which controls a hinge system 1650. The configurations illustrated in Figures 16A-C are configurable to reduce the total displacement required by the user to reach the various positions while using the device. As will be appreciated by reviewing the figures, an offset multiplier can be achieved so that a given user movement is amplified and thus requires less actual movement by the user on the slide. Thus, the movement achieved at the wrist is not 1:1 of the movement achieved at the distal end of the device. In the configuration illustrated in Figures 16A-16C, the hinge system comprises one or more rods 1651, 1651', 1651" and pins 1652, 1652', 1652". The articulation system is attached to a translational member such as a sheath, plunger or a cord control feature. As illustrated in Figures 16A-16C, slide 1642 moves along elongated guide 1640, and slide controls a hinge system 1650 which is secured in and moves with sheath 1632. As will be understood by those skilled in the art, hinge system components are adjustable to match target distances for sheath movement during, for example, phases 1, 2, and 3 of the IUD insertion procedure. In the aspect illustrated in Figures 16A-16C, the hinge system 1650 is attached to the proximal end of the hinge system 1650, and the hinge system 1650 is secured in the sheath at the distal end of the hinge system 1650.
[000120] A similar appearance is illustrated in Figures 17A-17C. Crank system 1750 features one or more rods 1751, 1751' and pins 1752, 1752', 1752". However, in this configuration, crank system 1750 couples slide 1742 at its distal end 20 and a gear 1753 at its distal end. proximal end 10. The crank system is positioned within the handle 1735 and at least a portion of the crank system 1750 operates within the elongated guide 1740. The crank system 1750 is further configurable to include an attached rotary gear or dial member 1753. at the proximal end of crank system 1750 to limit or control movement of the proximal end of crank system 1750. As gear 1753 is rotated about a central axis the longitudinal position of sheath control slide 1742 moves closer as the gear moves in a counterclockwise direction, as shown in Figures 17A-C. The pivot point shown in 1752" is configurable so that it remains stationary. ionary during movement shown in Figures 17. Where the 1752" pivot point remains stationary, the total linear movement required of the user is reduced. This facilitates one-handed operation by a user during use.
[000121] In another general class of configurations, as illustrated in Figures 18A-18B, the inserter 1800 includes a lever 1842 secured to a gear system 1855 that includes a first gear 1856, wherein the first gear 1856 moves a second gear gear 1857, where second gear 1857 is secured in sheath 1832. When lever 1842 is actuated by the inserter operator, for example by squeezing the lever, first gear 1856 causes second gear 1857 to move closer. , thereby moving the 1832 hem closer. Inserter 1800 may further include a spring (not shown) secured to lever 1842, which spring (not shown) provides a counterforce to user input force applied to lever 1842. Inserter 1800 is further configurable to include a ratchet mechanism, whereby the spring returns lever 1842 to its home position without causing the sheath to move distally.
[000122] In another embodiment, as illustrated in Figures 19A-19B, the inserter 1900 includes at least one gear or rack 1957 positioned within the handle housing 1935 secured to lever 1942. When lever 1942 is depressed by the operator, the 1957 gear moves a 1958 ratchet attached to the 1932 sheath, whereby the 1957 gear moves the sheath closer.
[000123] In other embodiments, as illustrated in Figures 20A-20D, 21A-21D, and 22A-22C, the inserters include position control features such as buttons 2042, 2046 which exhibit a vertical movement rather than a longitudinal movement along an elongated guide. In this way, the inserter operator can press down on one or more buttons to activate the position control features. For example, as illustrated in Figures 20A-20D, the inserters include a first button 2042 which is a sheath position control button, and a second button 2046 which is a lanyard control button on housing 2035. The lanyard control button activates a lanyard unlock feature; exemplary bead control features are discussed in more detail below. As illustrated in Figures 20A-20D, the first button is pressed down in step 1 to retract the hem. In step 2, a surface of the first button and a surface of the second button are aligned. In step 3, both the first and second buttons are pressed down to further retract the sheath and activate bead control features, such as a bead unlock feature. After step 3 is completed, the surfaces of the buttons can be aligned with the housing 2035 which provides a force limiting feature that prevents further downward movement of the buttons. In other embodiments, further movement of the knobs is prevented by a hard stop or soft motion control feature, such as features discussed in detail throughout the detailed description of this specification. As illustrated in Figures 20A-20D, the buttons can be telescopic with reaction to each other, whereby a first button moves through or within the second button. The embodiment illustrated in Figures 21A-21D is similar to the embodiment illustrated in Figures 20A-20D, except that sheath position control knob 2142, and lanyard control knob 2146 are located side by side in housing 2135 instead of in a telescopic configuration.
[000124] Figures 22A-22C illustrate an action mechanism for the sheath position control buttons described in Figures 20A-20D and 21A-21D, according to an exemplary embodiment of the present invention. As illustrated in Figures 22A-22C, sheath control knob 2242 positioned in housing 2235 contacts a sheath feature 2232r during one or more phases of the insertion procedure. For example, the hem feature can include a ramp or an inclined surface. When the button is pressed down by the operator, input force is translated from the button to the feature or surface 2242a of the button. Button feature or surface 2242a pushes against sheath feature 2232r and moves the sheath in the rearward direction. Additionally, or alternatively, as will be understood by those skilled in the art, the insertion device can be configured to push the plunger distally rather than pushing the sheath closer. As can be seen in Figures 22A-22C, button feature 2242a moves along ramp or sloped surface 2232r, allowing simultaneous downward movement of button 2242 and longitudinal movement of sheath 2232. This action mechanism is a non-limiting example modalities provided for in this description. Any suitable features and mechanisms are included in the present description, as will be understood by persons skilled in the art. For example, the inserter may include a gear system to allow simultaneous downward movement of the sheath position control feature and longitudinal movement of the sheath.
[000125] As described above, preserving a low profile dome shape at the distal end of the insertion device prevents or reduces trauma during the insertion process as well as premature leakage of the IUD from the insertion device during the insertion process. In certain insertion device modalities, in order to pass through the cervix without increased resistance, the insertion device must be positioned at the distal end of the tube so that the arms and hands of the IUD are pressed together and form an atraumatic configuration in the tip of the insertion device. The inserters of the present description are further adaptable to include one or more dimensional motion control features associated with the sheath and/or plunger to provide improved control of the distance between the plunger, the sheath, and the IUD so that the IUD remains securely in the proper position during one or more steps of the insertion procedure. Alternatively or in addition to the position control features discussed above which are associated with the slides, elongated guides, and housing, the sheath and/or plunger may include separate position control features directly attached to or associated with the sheath or plunger itself. These features can include dimensional motion control features to precisely control the distance between the plunger tip and the sheath tip. For example, as illustrated in the exemplary embodiments of Figures 23A-23C, the inserter may include a sheath 2332 and a plunger 2334, wherein one or both of the plunger 2334 and the sheath 2332 each comprise one or more control features. position associated with this. For example, plunger 2334 may include a first motion control feature 2338 having a first motion control surface 2338a and a second motion control surface 2338b on an opposing surface. Plunger 2334 may further include a second motion control feature 2339 which has a first motion control surface 2339a. As shown, first motion control surface 2338a of first motion control feature 2338 is configured to face or oppose first motion control surface 2339a of second motion control feature 2339. Sheath 2332 is further adaptable and configurable to including one or more first motion control feature 2336 having a first motion control surface 2336a configured to face the first motion control feature 2338a of the first motion control feature 2338 of piston 2334 and a second motion control surface. opposite motion 2336b configured to face the first motion control feature 2339a of the second motion control feature 2339 of piston 2334. Sheath 2332 is further adaptable to include additional motion control features such as one or more second motion control features. movement 2337a at a distal end and one or more third motion control features 2337b positioned proximal to the second motion control feature. As will be appreciated by those of skill in the art the motion control features 2336, 2337 illustrated in the cross section shown in Figures 23A-C may be distinct features placed at intervals under the inner surface of the sheath, or may form a continuous ring around an inner surface of the sheath.
[000126] As illustrated in Figures 23A-23C, the various position control features or motion control features, as well as the various motion control surfaces, are locatable at different positions along the longitudinal axis of the inserter 2300. Similar to the position control features discussed above, these features are adaptable to match various phases of the IUD insertion procedure. These motion control features or motion control surfaces are configurable to control the position of the inserter components during insertion, including the relative positions of the IUD, sheath, and plunger.
[000127] For example, in step 1 of an insertion procedure illustrated in Figure 23A, a proximal surface of the distal plunger movement control feature 2338 contacts a distal surface of the first sheath movement control feature 2336 such that the first motion control surface 2338a distal plunger motion control feature 2338 contact first motion control surface 2336a of first sheath motion control feature 2336, thereby preventing further movement of the plunger in the proximal direction of the sheath in the distal direction. Thus, motion control surfaces 2336a and 2338a are motion control surfaces that are hard relative to one another. As will be appreciated by persons skilled in the art these features or surfaces may also include soft motion control features or surfaces which merely impede rather than prohibit further movement. For example, as illustrated in Figures 23D-E, sheath 2332 includes one or more soft motion control features positioned distally 2337a, 2337b. In operation for the device shown in Figure 23D, sheath 2332 includes at least one motion control feature 2337c which is a cutout or stop that is conformable to a shape or profile of an IUD or a portion thereof. For example, stop 2337c allows the IUD hands (not shown) to rest on it and properly align the IUD along the longitudinal axis of sheath 2332. In addition, one or more stops 2337a can be positioned at limited locations as which are located in plane around an inner circumference of sheath 2332 to properly align the IUD arms in plane prior to positioning within the patient.
[000128] In step 2 of the insertion procedure illustrated in Figure 23B, sheath 2332 is recoiled in the proximal direction (or the plunger is advanced distally) so that the first motion control feature of sheath 2336 approaches the second motion control feature of proximally positioned plunger 2339. Inserter 2300 is configurable to include one or more additional motion control features such as a second sheath motion control feature 2337a and a third sheath motion control feature 2337b. These motion control features may be soft motion control features which merely prevent further movement of sheath 2332 and plunger 2338 relative to one another and/or provide an indication, such as tactile feedback, to the operator of insertion device that the insertion device 2300 performed an intermediate stage of the insertion procedure. Soft motion control features 2337a, 2337b can be further configurable to match the DIU position in step 2 as illustrated in Figure 4C and described above. These features provide a signal to the insertion device operator that the IUD arms are unfolded from the sheath. As illustrated in Figure 23B the one or more sheath soft motion control features 2337a may be positioned distal along the sheath relative to the first sheath motion control feature 2336, and/or to one or more sheath control features. Soft hem movement 2337b. Furthermore, motion control features 2336b are locatable proximally along sheath 2332 to the first sheath motion control feature 2336. These motion control features provide a low resistive force against plunger 2338 after the delivery device. insert 2300 be advanced beyond step 2 and to step 3. This can be achieved by minimizing the size or length of the first and second piston movement control features 2336, 2339 along the longitudinal axis of piston 2334 as illustrated in Figures 23D and 23E. Thus only a short length or portion of piston 2334 will contact resistive soft motion control characteristics 2337a, 2337b, 2337d. For example, piston motion control features 2336, 2339 are configurable to have a length which is similar to the length of sheath soft motion control features 2337a, 2337b, or may have a shape such as a curved shape. or rounded, which minimizes contact between the piston motion control characteristic 2338 and the soft motion control characteristic 2337d.
[000129] In step 3 of the insertion procedure illustrated in Figure 23C, sheath 2332 is further retracted closer (or the plunger is advanced distally), and the proximal plunger motion control feature 2339 contacts the first feature of sheath motion control 2336 such that the first motion control surface 2339a of the proximal plunger motion control feature 2339 contacts the second motion control surface 2336b of the first sheath motion control feature 2336, thereby preventing further movement of the plunger in the proximal direction and the sheath in the distal direction. Thus, motion control surfaces 2336b and 2339a are motion control surfaces that are hard relative to one another. As will be appreciated by persons skilled in the art, these features or surfaces may also include soft motion control features or surfaces which merely impede rather than prohibit further movement.
[000130] As will be understood by those skilled in the art, the present description includes variations of the exemplary embodiment illustrated in Figures 23A-23C. For example, the sheath and/or plunger may include any suitable number of motion control features which may include any suitable number or arrangement of motion control surfaces. As discussed above with reference to the position control features of the slides, the elongated guide, and the housing, the piston and/or sheath motion control features may include any suitable type of hard motion control features, speed control features. soft movement, or any suitable combination thereof. For example, motion control features or surfaces may include physical features such as stops, notches, grooves, protrusions, tabs, edges, flanges, flaps, ports, flexible members, contours, curves, shapes, etc. Furthermore, although the motion control features or surfaces are preferably located proximal to the distal or front end of the inserter, such features or surfaces may suitably be located in any suitable position along the longitudinal geometric axes of the sheath and plunger .
[000131] With these plunger and sheath motion control features, loading of the plunger and IUD into the sheath prior to insertion is achievable by preloading the components during insertion device fabrication. In addition, motion control features are available so that motion control features are aligned in a first position and then misaligned in a second position which is obtainable when rotating one or more of the plunger and sheath one in relation to the other, thereby allowing the IUD and plunger to be loaded into the sheath by first rotating the components, then sliding the plunger motion control features in addition to the sheath motion control features, and finally rotating the components again to realign the plunger and sheath motion control features so that they are aligned during the insertion procedure. In another embodiment, the IUD can be loaded into an opening in the housing/cuff or in the side wall of the sheath, as discussed in more detail below.
[000132] In yet another embodiment, the inserters are adaptable to include a plunger having a feature to lock the IUD in place to prevent the IUD from moving relative to the plunger along the longitudinal axis of the inserter during one or more stages of the insertion procedure. For example, the plunger may include a feature which grips or grips the IUD during at least the first stage of insertion, and optionally the second and third stages. For example, the plunger can grip or pinch the IUD at the proximal end of the IUD near the cords, or grab or pinch the IUD cords. The insertion device may further include an IUD unlocking feature. For example, the sheath may include a feature which unlocks the IUD from the plunger as the sheath is moved during step 2 or step 3, or after step 3.
[000133] The inserters of the present description are further adaptable to include features which provide an atraumatic distal or front end or tip of the inserter to minimize pain induced by the inserter as it passes through the patient's cervix and to inside the uterus, as well as during the removal of the insertion device from the patient after the IUD is inserted. The inserters of the present description are also adaptable to include features which minimize the cross-sectional dimensions of the distal end of the inserter during insertion and reduce or eliminate blunt or abrupt features at the distal end of the inserter which may cause pain or discomfort to the patient as the insertion device passes through the cervix during use.
[000134] Inserters are also configurable to include a sheath 2432 having a tapered or rounded distal tip or tip 2432t, wherein the cross section, or outside diameter, D, of the inserter sheath decreases by one more value. towards the end or distal point of the insertion device, as illustrated in Figures 24A-24G. Sheath tip 2432t is tapered or taper toward the distal end of sheath 2432, as illustrated in Figures 24A-24B. As illustrated in Figure 24B, sheath wall thickness T 2432 may also be minimized at the distal end of sheath 2432 to reduce the impact of sheath wall thickness on the patient. Sheath wall thickness can be reduced at the distal end of the sheath relative to the thickness measured at a different location along the longitudinal axis of sheath 2432. Keeping a thicker sheath wall away from the distal end of the sheath will allow for proper rigidity of the sheath, while a reduced sheath wall thickness near the 2432t sheath tip will minimize any abrupt features which may scratch or pinch the patient during insertion. As illustrated in Figure 24C, the ends 2432e of the sheath wall may be further rounded to minimize the sharp or abrupt features of the inserter. Inserter sheath 2432 may also include an opening 2432o, as illustrated in Figures 24A-24C.
[000135] In another general class of embodiments, as illustrated in Figures 24D-24F, sheath tip 2432t is formed so that the IUD is substantially or completely covered by sheath 2432 during an early stage of the insertion procedure, for example, when the insertion device is inserted through the cervix. At this early stage of the procedure the devices are configurable so that the sheath does not or almost completely lack an opening in the 2432t sheath tip. The tip can be formed as part of the sheath as illustrated in Figure 24D. Alternatively, as illustrated in Figure 24E, the sheath tip may include a separate component such as a sheath cap or cover 2432c which mounts or slides over the sheath 2432 to cover the end of the sheath during insertion. Preferably, the sheath cover has a thickness which is thinner than the sheath wall, but is made of a material which is strong enough to contain the IUD during insertion. The sheath cover can be made of a material which is the same as the sheath material, or the sheath and cover can comprise different materials. The cover is configurable to be secured to the sheath through mechanical force or chemical adhesion, including suitable fastening methods known in the art. As will be appreciated by those skilled in the art, if the diameter of the tapered tip is less than the diameter of the opening of the outer cervix orifice, and then gradually increases in diameter along its length to accommodate the IUD, the tip can be advanced. through the external orifice and as the diameter of the device increases the device will apply lateral pressure on the walls of the cervix causing the opening to the cervix to slowly increase in diameter to accommodate the remainder of the device.
[000136] In another exemplary embodiment, as illustrated in Figure 24F, the inserter includes an outer sleeve or sheath 2432a and at least one inner sheath 2432b. The 2402 IUD is housed by the inner sheath 2432b, and the inner sheath slides into the outer sheath 2432a in a telescopic fashion so that the inner sheath and the IUD can be loaded into the outer sheath to prepare the inserter for the procedure. of IUD insertion. The exemplary embodiment illustrated in Figure 24F features an inner sheath 2432b comprising the tapered or rounded sheath tip 2432t. However, as will be understood by those of skill in the art, the inner sheath and/or the outer sheath is configurable to comprise the 2432t sheath tip. Preferably, the interface i between the sheath and cap of Figure 24E, or between the inner and outer sheaths of Figure 24F, is an uninterrupted interface which does not pinch, scratch, adhere or otherwise harm the patient during the procedure. insertion. For example, the uninterrupted interface is obtainable by matching the outer diameter of both components at the interface, i, for example, by matching the outer diameters of sheath 2432 and sheath cap 2432c at interface i shown in Figure 24E, or by matching the outer diameters of outer sheath 2432a and inner sheath 2432b at interface i shown in Figures 24F-G. In the embodiment illustrated in Figure 24F, inner sheath 2432b may include a lip 2432l which allows the outer diameter of inner sheath 2432b to match the outer diameter of outer sheath 2432a, while at the same time allowing the inner sheath to slide within the outer sheath. along the portion of the inner sheath which is below the lip 2432l. In another exemplary embodiment (not shown), the interface may be located at a distance along the longitudinal axis of the inserter that is far enough from the distal end of the sheath such that the interface will not enter the patient's cervix during the insertion procedure.
[000137] As the sheath and plunger motion control characteristics are small due to their position within the sheath or affixed to the plunger, the inserters are configurable to include one or more force limiting characteristics such as those described above , to prevent the user from applying excessive force to the slide which could subsequently break or damage the sheath and plunger motion control features. IV. WIRE LOCKING AND UNLOCKING FEATURES
[000138] As described above, the inserters of the present description include one or more string control features or mechanisms. The lanyard control feature can include one or more lanyard locking features and at least one lanyard unlocking feature or mechanism. The one or more strand control features or mechanisms may include manual features, automatic features, or a combination thereof.
[000139] In a general class of configuration, as illustrated in Figures 25A-25B and 26A-26E, the inserters are adaptable to include a dimensional feature such as an opening, stop, notch, wedge, or slot 2548, by means of that one or more IUD cords (not shown) are securely attachable within the dimensional characteristic. The dimensional bead locking feature is formable in inserter housing 2535 or as part of another suitable inserter component. In an exemplary embodiment, the insertion device operator may pull the IUD strings into the 2548 dimensional string lock feature when loading the IUD into the insertion device. In additional embodiments, strands may be automatically placed or locked within the strand locking feature, as discussed below in additional embodiments. The one or more bead locking features can function to control the position of the IUD during insertion and/or move the beads out of the way to prevent the beads from interfering with the insertion procedure. Additional advantages will be appreciated by people skilled in the art. Cords can be manually, automatically or semi-automatically removed from the 2548 locking feature upon completion of IUD insertion.
[000140] In addition to the at least one lanyard locking feature, the inserter includes one or more lanyard unlocking features to remove the strands from a locked position. The one or more unlocking features can include manual and/or automatic lanyard unlocking features. As illustrated in the exemplary embodiment of Figures 26A-26E, the inserter may include a movable cord control feature 2649 which pushes or releases the cords out of the cord locking feature 2648. As illustrated in Figures 26A-26E, the inserter includes a movable cord release feature which can move past or through the cord lock feature 2648. As discussed above and illustrated in Figures 26A-26E, the cord lock feature may include an aperture or feature. dimensional in the inserter housing 2635. When the strand unlock feature 2649 is in a first position, the strands remain locked within the strand lock feature 2648. When the strand unlock feature 2649 is moved, the strands are released or unlocked by the lanyard unlock feature 2649.
[000141] As in the exemplary embodiment illustrated in Figures 26A-26C, the inserter may include a feature 2649 which is both a cord locking and a cord unlocking feature. For example, bead control feature 2649 is configurable to lock the IUD cords in place by clamping the cords against housing 2635 in a first position (not shown). For example, the strands can be clamped or locked onto the strand lock feature 2648 by the strand control feature 2649. When the strand control feature is moved (e.g., pushed closer), as illustrated in Figure 26A, the strands are released from the lanyard locking feature 2648 as the strand locking and unlocking control feature 2649 is no longer pinching or locking the strands against the housing 2635, the strand locking feature 2648, or other device component of insertion. As illustrated in Figure 26A, housing or strand locking feature 2648 and/or strand unlocking feature 2649 may include an angled or slanted surface, whereby a surface of strand unlocking feature 2649 contacts a surface of the lanyard lock feature 2648 when lanyards are locked and surfaces are not in contact when strands are unlocked.
[000142] In the exemplary embodiments illustrated in Figures 26D-26E, the lanyard locking feature 2648 locks or controls the strands a dimensional feature in the inserter housing 2635, and the lanyard unlocking feature 2649 releases, releases or unlocks the strands when it is moved from a first position (as shown in Figure 26D) to a second position (as shown in Figure 26E). For example, the strands are positionable so that they extend beyond, or project through, a proximal end of the inserter through an opening in the lanyard unlocking feature 2649. For example feature 2649 may include a hollow tube portion through from which the cords are threaded. In this embodiment, the strands are pulled firmly from the opening in the feature 2649 and into the strand lock feature 2648. When the strand unlock feature 2649 is moved closer, the unlock feature 2649 pushes against the strands to remove it. these of the locking feature 2648. As will be understood by persons skilled in the art, these exemplary non-limiting embodiments are illustrated to illustrate the lanyard control features provided by the present description, and additional operating modes and mechanisms are included, such as the embodiments discussed throughout this specification.
[000143] The lanyard control feature 2649, which may be a lanyard locking and/or lanyard unlocking feature, is further configurable to be controllable by a strand control feature such as a slide 2646, as illustrated in Figures 26D-26E. As illustrated in Figure 26D, lanyard control feature 2646 includes a slide position return feature 2646r which allows the user to move slide 2646 back to its home position. The slide position return feature may include a spring, stop, tab, or any other suitable feature, as will be understood by those skilled in the art. Lanyard control feature 2646 is adaptable to include a telescopic lanyard control slide, for example, as in the embodiment illustrated in Figures 13-15, as discussed in more detail above. Alternatively, or in addition, lanyard control feature 2649 is controllable by one or more lanyard release buttons 2647, as illustrated in Figures 26B (top view) and 26C (side view). Buttons 2647 may be located in or on the housing at a location separate from the sheath control slide 2642, as illustrated in Figures 26B-26C. The at least one button 2647 may include a slide, a push-button, or any other suitable control feature or mechanism for moving the lanyard unlocking feature 2649. The lanyard control feature 2649 may be adapted and configured to include a member elongate which is physically attached to or operatively connected to one or more lanyard control features such as lanyard release slide 2646 or lanyard release button 2647.
[000144] Figures 27A-27C show additional details of the inserter 800 illustrated in Figures 8A-8F and described in more detail above. In one configuration, as illustrated in Figures 27A-27C, the inserter includes a strand control feature 2747 which comprises one or more dimensional strand locking features 2748. The strand locking features 2748 are configurable so that each A feature includes a surface 2748a adapted and configured to clamp or lock one or more IUD strands 2710 which extend from within elongated sheath 2732 against another component or surface of the inserter. Strand locking features 2748 or surfaces 2748a are formable from ramps, curved surfaces, sloped surfaces, rounded features, depressions, protrusions, or other suitable dimensional features. The lanyard control feature 2747 provides both a lanyard lock and lanyard unlocking mechanism. When the bead control feature is moved from a first position to a second position, the IUD bead is locked or constrained in a first position or unlocked or unrestrained. When the strand control feature 2747 is in a first position, as illustrated in Figure 27C, the at least one IUD strand 2710 is lockable or constrainable in place by the strand lock feature 2748, whereby the surface 2748a of the feature 2748 clamps, presses or constrains the cord against another component or surface of the inserter (not shown), such as an inner surface of the handle 2735. When the cord control feature 2747 is moved to a second position, as illustrated in Figure 27C, the cord is released from the locked position. Strand locking features 2748 include a curved or slanted surface to allow for a gradual locking or restriction of the inserter as the curved or slanted surface moves across the string. Lanyard control feature 2747 is movable through a range of motion from the locked to unlocked position by sliding, swinging or otherwise moving the feature 2747.
[000145] In yet another embodiment, the inserter includes a cord locking feature comprising one or more grooves or teeth which grip and lock the cord in place by pinching the cord against the grooves or teeth of another surface of the device of insertion. For example, as illustrated in Figure 28, strand locking feature 2847 comprises a first component with at least one surface having teeth 2848a. The strand locking feature 2847 may further comprise a second component with at least one surface having teeth 2848b wherein the teeth of the first component face the teeth of the second component. Moving the strand locking feature 2847 towards the second component surface 2848b causes the two surfaces having teeth to engage or clamp a strand 2810 positioned between the surfaces, thereby locking the strand in place. In one embodiment, the lanyard is locked or restrained by pressing the lanyard control feature 2847 and released or unlocked by releasing the lanyard control feature 2847. In other embodiments, the lanyard is lockable by another feature such as a hitch or hinge which secures surfaces 2848a, 2848b together. In still other embodiments, strand control feature 2847 is moved by sliding or rotating strand control feature 2847, whereby the strand is clamped between a first surface of strand control feature 2847 and a second surface, at that the first and/or the second surface comprise teeth or grooves. As will be appreciated by those skilled in the art, the cord control mechanisms are adaptable to secure a cord in a first position, and then release the cord, or control cord tension with respect to the IUD during placement by restricting the cord or cords until the cord is released. Thus, all lanyard locking and unlocking features and mechanisms are adaptable to lock, constrain, tension, or release (either partially or fully) the strands that engage the mechanisms.
[000146] In still other embodiments, the cord locking and unlocking feature or mechanism is adaptable to include a hinge or clamp feature, whereby the cords are locked when the hinge or clamp is closed or tightened, and the lanyards are unlocked when the hinge or clamp is opened or loosened.
[000147] In yet another embodiment, the insertion devices are configurable to include one or more mechanisms which prevent the user from positioning the IUD while the cords remain in a locked or restricted position. Such a feature can facilitate the prevention of pain associated with the insertion procedure when the device operator pulls on the positioned IUD cords, for example, when the inserter attempts to withdraw the inserter post-insertion while the cords remain locked. Requiring the lanyards to be unlocked before the insertion device allows full IUD deployment, the preventative feature provides a feedback mechanism, signal or reminder to the operator that the strands need to be unlocked before proceeding with the procedure.
[000148] In an exemplary embodiment, as illustrated in Figures 29A-29D, the inserters described herein are configurable to include a lanyard lock and unlock feature 2947, which includes one or more alignment features 2960. As illustrated in Figures 29A-29D, IUD cords are locked and unlocked by the cord control feature 2947. The cord 2910 passes through an opening 2948. For example, sliding or rotating the cord control feature 2947 can lock and unlock the cords depending on the direction the feature is moved or rotated. When strands are locked or clamped by the strand lock feature 2947, as illustrated in Figure 29B, the strand control feature 2947 exhibits an interface which prevents the sheath from proceeding beyond the strand control feature interface. For example, the sheath may include one or more dimensional features 2961, such as tabs or protrusions, which align with one or more features 2960 of strand control feature 2947, such as apertures 2960, 2960' illustrated in Figures 29A- 29D. When the strands are locked, the sheath features 2961, 2961' are not aligned with the openings 2960, 2960' in the strand lock feature 2947, and the sheath 2932 cannot be retracted, as illustrated in Figure 29B. When the strands are unlocked, the sheath features 2961, 2961' are aligned with the openings 2960, 2960' in the strand lock feature 2947, and the sheath can be retracted, as illustrated in Figures 29C-29D.
[000149] In yet another embodiment, the inserter includes a cord cut feature. The strand cut feature may be a strand unlocking feature, whereby the strands are cut by a strand cut feature and hereby released from a locked position. Alternatively, the strand cut feature can be separated from the strand unlock feature. As will be understood by those skilled in the art, the cord cutting feature may include a blade or any known mechanism suitable for cutting or severing the IUD cords.
[000150] Characteristics of locking or unlocking cord or manual, automatic or semi-automatic are contemplated in the insertion devices of the present description. Incorporating any of the aforementioned features, the inserters are configurable to include an automatic lanyard locking feature, whereby strands are automatically locked and unlocked by the inserter without requiring additional procedural steps or user input. The automatic locking and unlocking features can include any suitable features or mechanisms known in the art, as well as the features of the present description discussed herein. For a manual process, a user pulls the strands when the device is in a correct or desired position or configuration, for example, when a dome shape is achieved, and then positions the one or more strands within the slit so that the walls from the slit clamp the cords, thereby locking the cords in place. V. RETURN CHARACTERISTICS
[000151] As described above, the inserters of the present description are adaptable and configurable to include one or more indicator or signal characteristics which provide a sensory signal to the user that the IUD and other inserter components are in a appropriate or targeted position that corresponds to one or more phases of the IUD insertion procedure. The sensory indicator or user feedback features of the present description include, but are not limited to, a visual indicator such as a visual alignment feature described above, an auditory indicator such as a click or other noise heard by the insertion device operator. , and/or a tactile forefinger feature which can be felt by the operator such as a tactile forefinger felt by the operator's finger or thumb (e.g., when one component of the device couples another component, such as with configurations having the soft motion control features).
[000152] Insertion devices are further configurable to include one or more signal features to alert the operator at various stages of the insertion procedure or provide assurance that the IUD is properly positioned, thereby signaling the operator to perform the next step in the procedure. Likewise, such guidance may inform the clinician of instances where the IUD is improperly positioned, either for lack of the aforementioned positive sign that shows proper IUD placement, or by including an additional negative sign feature. Inserters include non-visible pointing features such as tactile or audible pointing features. In this way, the inserter provides indicators without requiring the user to look away from the patient and back to the inserter, whereby the user can focus on the patient at the insertion point.
[000153] In further aspects of the description, the inserters are adaptable to display a visual indicator symbol such as an image, word, number, pattern, color change, or the like whenever the IUD location corresponds to a step of procedure (or, conversely, whenever the IUD location does not match a procedure step). As illustrated in Figures 30A-30B, the inserter indicating features may include symbols 3070 which show the IUD positioning that corresponds to the inserter positioning and procedure step. For example, slide 3042 may include a viewing window 3071 which displays a symbol showing corresponding IUD placement at various slide positions. When slide 3042 is moved by the operator, the window lines up with and shows the appropriate symbol printed or molded over the inserter housing or other inserter component that corresponds to a configuration of the IUD and/or inserter. IUD in a corresponding procedure step. SAW. PRE-INSERTION IUD LOADING
[000154] The present description includes various features to prepare the insertion device for the IUD insertion procedure, as well as relative methods. For example, the IUD 3102 can be loaded into housing or sheath 3132 through one or more openings 3132h in the inserter sheath, including an outer sheath 3132a or inner sheath 3132b, as illustrated in Figures 31A-31B.
[000155] In additional aspects, as illustrated in Figures 32A-32B, the IUD 3202 and the plunger 3234 are simultaneously loaded into the inserter through an opening 3235h in the inserter housing 3235. The plunger 3234 is adaptable and configurable to includes one or more features 3234f for securing plunger 3234 to housing 3235 when loading plunger 3234 and IUD 3202 into the inserter. As illustrated in Figure 32B, the inserter may be further adapted and configured to include a packaging sleeve or inner sheath 3232b which provides a loading sheath for folding the IUD 3202 for loading into the inserter. The packaging sleeve or inner sheath 3232b may include one or more stop features 3232c to stop the packaging sleeve 3232b from moving into the outer sheath 3232a as the plunger 3234 is inserted through the housing and into the outer sheath. For example, stop feature 3232c is configurable to include a dimensional feature such as a protrusion which contacts a surface within housing 3235 and prevents the packing sleeve from further movement. The IUD can be a T-shaped IUD, or any other IUD configuration, which is prepackaged with the IUD arms in the extended position. The packaging sleeve can be slipped over the IUD prior to loading the IUD to fold the IUD arms together for loading onto the inserter.
[000156] In another aspect, the upper and lower parts of the handle or housing can be separated or opened to allow loading of the plunger and the IUD. For example, the housing may include a hinge which allows the housing to swing open for IUD loading.
[000157] In yet another aspect of the present description, the sheath or plunger position control features allow movement of the sheath or plunger to load the IUD into the sheath for insertion. For example, the IUD can be loaded into the insertion device sheath by advancing the sheath distally to cover the IUD prior to insertion. The insertion device may include a sheath slide located at a second mid-position along the elongated guide prior to insertion of the IUD. While the IUD is locked into the plunger or housing, the slide is moved distally to advance the distal sheath and cover the IUD arms. Then, the insertion procedure is started with the sheath slider in the first distal position. Step 2 of the insertion procedure involves moving the sheath slider back to the second mid position, and step 3 involves moving the sheath slider back to the proximal third position along the elongated guide.
[000158] Although various aspects of the present description have been described above, it should be understood that these have been presented as examples only, and not limitation. It will be apparent to persons versed in the relevant technique that various changes in form and detail can be made to it without departing from the spirit and scope of the description. Thus, the extent and scope of the present description is not to be limited by any of the exemplary aspects described above, but is to be defined only in accordance with the following claims and their equivalents. As will be understood by persons skilled in the art, any of the above device components or process may be used in any suitable combination to form the inserter of the present description.
[000159] Although 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 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 can be employed in the practice of 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 are covered therein.

权利要求:
Claims (13)
[0001]
1. Inserter (800, 1300, 1400) for an IUD, the inserter comprising: an elongated sheath (832, 1332, 1432) having a proximal end and a distal end and a lumen extending between the end. proximal and distal end; an elongated inner member (834) having a proximal end and a distal end splayable within the lumen of the elongated sheath (832, 1332, 1432); a proximally positioned user interface (835, 1335, 1435), wherein the proximally positioned user interface further comprises a housing having one or more elongated guides (840, 1340, 1440) formed at least partially therein. and along at least a portion of a length thereof; and a movable sheath slide (842, 1342, 1442) in communication with the elongated sheath wherein the movable sheath slide is adaptable and configurable to move securely within the elongated guide and wherein, in addition, the movable sheath slide controls axial movement of the elongated sheath, wherein the elongated guide further comprises one or more motion control features along its length and wherein the one or more motion control features comprise at least one force limiting feature (844 ) configurable to limit an amount of force applied to the movable sheath slide, and characterized by the fact that: the one or more motion control features is/are adapted to provide tactile feedback, and the insertion device comprises further a bead control slide (1046, 1346, 1446), wherein the sheath slide and the bead control slide are further configurable to comprise one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group comprising a first vertical sheath slide surface, a second vertical sheath slide surface, a first vertical bead control slide surface and a second vertical bead control slide surface, wherein one or more of the vertical surfaces are configured to form an adjacent surface aligned at one or more positions along the length of the elongated guide.
[0002]
2. Insertion device according to claim 1, characterized in that the one or more force limiting or motion control characteristics are selected from the group comprising stops, notches, grooves, protuberances, flaps, edges , flanges, flaps, ports, flexible members, contours, curves and shapes.
[0003]
3. Insertion device according to claim 1, characterized in that the elongated guide: has a length, a width and a depth, and wherein, in addition, the width of the elongated guide is at least one of a length variable along and a stepped width selected from two or more of a first width and a second width; or has a plane profile selected from rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semicircular and oval; or further comprises one or more cavities (1045, 1345, 1445a, 1445b) in one or more of the proximal end of the elongated guide and the distal end of the elongated guide wherein the one or more cavities are adapted and configured to accommodate at least one portion of the movable sheath slide.
[0004]
4. Insertion device according to claim 1, characterized in that the sheath slide comprises one or more surface profiles adapted and configured to mechanically complement the one or more motion control features, wherein, optionally, the one or more surface profiles of the sheath slide are selected from the group comprising one or more of each of non-planar surfaces, curved surfaces and angled surfaces.
[0005]
5. Inserter according to claim 1, characterized in that the housing and the sheath slide further comprise one or more alignment surfaces (1044a, 1042b), wherein the one or more housing alignment surfaces are adapted and configured to mechanically complement the one or more alignment surfaces of the sheath.
[0006]
The inserter of claim 5, characterized in that: a first sheath slider alignment surface aligns with a first housing alignment surface at a first position along the length of the elongated guide; or the one or more sheath slide alignment surfaces and the one or more housing alignment surfaces are selected from the group comprising a curved surface, an angled surface and an inclined surface.
[0007]
An inserter according to claim 1, further comprising a strand control slide (1046, 1346, 1446), wherein, optionally, the strand control slide is adaptable and configurable to move safely inside the elongated guide.
[0008]
8. Insertion device according to claim 1, further comprising a cord control slide, wherein: the elongated sheath slide and the cord control slide are adapted and configured to operate at least one of simultaneously and independently within one or more elongated guides; or the sheath slide and the bead control slide are telescopically movable along at least a first portion of the elongated guide, and wherein, in addition, the sheath slide and the bead control slide are configurable so that at least at least one of the sheath slide and the cord slide partially surrounds the remaining slide; or the sheath slide and bead control slide have a combined width less than or equal to at least one of 19 mm (0.75 inches), 17.8 mm (0.7 inches), 12.7 mm ( 0.5 inches), 8.9 mm (0.35 inches) or 6.3 mm (0.25 inches).
[0009]
9. Inserter according to claim 1, characterized in that the inserter is configurable to receive an IUD within the distal end of the elongated sheath lumen which additionally comprises at least one cord locking feature ( 1346) adaptable and configurable to secure one or more IUD cord components.
[0010]
10. Insertion device according to claim 9, characterized in that the at least one cord locking feature comprises one or more of a slot, a clip, a wedge, a clamp, a spring or teeth, in whereas, optionally, when the cord locking feature comprises a slit, the spring unlocking feature comprises a movable member which pushes the one or more springs out of the slit to unlock the one or more springs.
[0011]
11. Insertion device according to claim 1, characterized in that the distal end of the elongated sheath has an atraumatic tip selected from the group comprising a rounded tip and a tapered tip, and optionally the distal end of the sheath elongated: has an outer diameter of about 3mm to 5mm; or has an outside diameter that is equal to or less than 80%, 50%, 30% of the outside diameter of the proximal end of the elongated sheath; has an outside diameter that is less than the maximum cross-sectional dimension of an IUD positionable within the lumen of the elongated sheath; or further comprises one or more slits or flaps at the forward end of the sheath.
[0012]
Insertion device according to claim 1, characterized in that it further comprises one or more feedback mechanisms selected from the group comprising audible, visible and tactile.
[0013]
Kit characterized by comprising: the insertion device (800, 1300, 1400) as defined in any one of claims 1 to 12; and an intrauterine device positionable within the distal lumen of the elongated sheath.

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NZ619783A|2016-03-31|

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KR20140051296A|2014-04-30|

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CA3099636A1|2013-01-17|

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US20180303660A1|2018-10-25|

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EP2731562A2|2014-05-21|

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MX357354B|2018-07-05|

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BR122015016218A2|2019-08-27|

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US11090186B2|2021-08-17|

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CA2841855A1|2013-01-17|

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CN104023681B|2016-08-31|

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CA2841855C|2021-01-12|

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EP2731562A4|2014-12-17|

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EP2731562B1|2018-09-12|

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AU2012282832A1|2014-01-23|

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MX2014000405A|2017-02-15|

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AP2014007363A0|2014-01-31|

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US20130014762A1|2013-01-17|

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WO2013009674A2|2013-01-17|

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EA201490251A1|2014-06-30|

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BR112014000440A2|2017-02-14|

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US10028858B2|2018-07-24|

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US20210393434A1|2021-12-23|

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PE20142239A1|2015-01-08|

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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-22| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-15| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-04-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-05-25| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/07/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161506434P| true| 2011-07-11|2011-07-11|

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US61/506,434|2011-07-11|

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US13/539,843|2012-07-02|

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US13/539,843|US10028858B2|2011-07-11|2012-07-02|Intrauterine systems, IUD insertion devices, and related methods and kits therefor|

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PCT/US2012/045906|WO2013009674A2|2011-07-11|2012-07-09|Intraurinary systems, iud insertion devices, and related methods and kits therefor|BR122015016218-1A| BR122015016218B1|2011-07-11|2012-07-09|insertion device|