Patent Publication Number: US-2022233343-A1

Title: Intrauterine device

Description:
This application claims priority from provisional application 62/862,056, filed, Jun. 15, 2019, the entire contents of which is incorporated herein by reference. 
    
    
     BACKGROUND 
     Technical Field 
     This application relates to an intrauterine device inserted into the uterine cavity to prevent egg fertilization. 
     Background 
     Intrauterine devices (IUD) which are inserted into the uterine cavity to prevent egg fertilization are known. The IUD as a foreign body interferes with human reproduction through a localized inflammatory reaction of the endometrial and myometrial functions of the uterus. Cellular and humoral immune-inflammatory responses mediate the localized inflammation. Many IUDs use the hormone progestin which is released to prevent sperm from fertilizing eggs. Other common IUD&#39;s are composed of copper, which affects sperm cells through the release of copper ions which are toxic to sperm and also cause the uterus and fallopian tubes to produce a fluid which is also toxic to sperm, Copper and hormonal IUDs have active ingredients that are absorbed by the body thereby creating additional localized changes as a result of hormonally related changes to secretions and spermicidal affects. 
     When an IUD is placed, the endometrial surface layers are eroded down to the basement membrane. This effect is more pronounced with larger IUDs and when there is greater contact area to the endometrium. The erosion of the endometrial surface layers causes defects in the vascular epithelium, hemorrhages unchecked by hemostasis, and direct bleeding from the ulcerated areas in contact with the IUD. In IUD users, this affects the entire genital tract because of luminal transmission of the fluids that accumulates in the uterine lumen. The immune-inflammatory response affects events prior to implantation, specifically ovum development in the tubes, sperm migration, and ovum transport in the uterus. It also affects the function or viability of gametes, decreasing the rate of fertilization and lowering the chances of survival of any embryo that may be formed, even before it reaches the uterus. 
     However, there are drawbacks with copper IUDs such as allergies and heavier periods. Drawbacks of hormonal IUDs include missed periods, bleeding and spotting between periods, weight gain, acne, increased risk of idiopathic intracranial hypertension, and increased adverse effects for women with a history of some cancers. It is also inadvisable to use a hormonal IUD while breastfeeding. 
     SUMMARY OF INVENTION 
     The present invention overcomes the problems and deficiencies of the prior art. The present invention provides an intrauterine device placed within the uterine cavity to prevent egg fertilization. In the intrauterine devices of the present invention, unlike copper or hormonal IUDs. the mechanism of action is only physical contact with the endometrium. Thus, the primary mode of action is a foreign body physical contact of the device to the endometrium. 
     The devices of the present invention provide increased surface area to fill the uterine cavity and better conform to the uterine cavity. Several embodiments of the device are disclosed herein and discussed in detail below. 
     In accordance with one aspect of the present invention, an intrauterine device for preventing egg fertilization is provided including a membrane and frame having first and second arms movable from a first position and a second more expanded position, the frame supporting the membrane to move the membrane between a first position and a second more expanded position. The first and second arms are non-planar and each arm has a proximal portion, an intermediate portion and a distal portion. The first arm has a bend at the intermediate portion so the intermediate portion of the first arm lies in a different plane than the proximal portion of the first arm and the second arm has a bend at the intermediate portion so the intermediate portion of the second arm lies in a different plane than the proximal portion of the second arm. An elongated tail portion extends proximally of the membrane. 
     In some embodiments, the membrane has a proximal portion closer to the tail portion and a distal portion, the distal portion having a convex end. 
     In accordance with another aspect of the present invention, an intrauterine device for preventing egg fertilization is provided including a membrane, a frame having first and second arms movable from a first position to a second more expanded position, the frame supporting the membrane to move the membrane between a first position and a second more expanded position. The first and second arms each have a proximal portion, an intermediate portion and a distal portion. The membrane is supported between the first and second arms and has a proximal portion closer to the tail portion and a distal portion, the distal portion having a convex end. An elongated tail portion extends proximally of the membrane. 
     In some embodiments, the first arm terminates in a first bead and the second arm terminates in a second bead. In some embodiments, the frame has a silicone coating thereover. In some embodiments, the frame and first and second beads have a silicone coating thereover. In some embodiments, the silicone coating includes barium for radiopacity. 
     In some embodiments, the membrane is composed of a non-copper material. 
     In some embodiments, the membrane is composed of a non-reactive material. 
     In accordance with another aspect of the present invention, the devices of the present invention are provided in combination with a delivery system, the delivery system having an inner tube with an elongated slot to receive the tail portion of the device and an outer tube. The inner tube is positioned within the outer tube, the outer tube maintaining the frame in the first position. 
     In some embodiments, the outer tube and inner tube are relatively movable. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical apparatus disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein: 
         FIG. 1A  is a plan view of a prior art intrauterine device, 
         FIG. 1B  is a side view of the prior art device of  FIG. 1A ; 
         FIG. 1C  is a cross-sectional view taken along line A-A of  FIG. 1B ; 
         FIG. 2A  is a plan view of one embodiment of the intrauterine device of the present invention having a concave distal edge; 
         FIG. 2B  is a side view of the device of  FIG. 2A ; 
         FIG. 2C  is a cross-sectional view taken along line A-A of  FIG. 2B ; 
         FIG. 2D  is a plan view of a larger size intrauterine device of  FIG. 2A  having a convex distal edge; 
         FIG. 2E  is a side view of the device of  FIG. 2D ; 
         FIG. 2F  is a cross-sectional view taken along line A-A of  FIG. 2E ; 
         FIGS. 2G and 2H  are plan and side views, respectively, and  FIG. 2I  is a cross-sectional view taken along line A-A of  FIG. 2H , of the device of  FIG. 2A  showing an example of dimensions of the device; 
         FIGS. 2J and 2K  are plan and side views, respectively, and  FIG. 2L  is a cross-sectional view taken along line A-A of  FIG. 2K , of the device of  FIG. 2D  showing an example of dimensions of the device; 
         FIG. 3A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having a non-planar side profile; 
         FIG. 3B  is a side view of the device of  FIG. 3A ; 
         FIG. 4A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having a planar and a non-planar side; 
         FIG. 4B  is a side view of the device of  FIG. 4A ; 
         FIG. 4C  is a perspective view of the device of  FIG. 4A ; 
         FIG. 5A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having two non-planar sides; 
         FIG. 5B  is a side view of the device of  FIG. 5A ; 
         FIG. 5C  is a perspective view of the device of  FIG. 5A ; 
         FIG. 6A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having a frameless membrane; 
         FIG. 6B  is a side view of the device of  FIG. 6A ; 
         FIG. 6C  is a cross-sectional view taken along line A-A of  FIG. 6B ; 
         FIG. 7A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having a frameless mesh web; 
         FIG. 7B  is a side view of the device of  FIG. 7A ; 
         FIG. 7C  is a cross-sectional view taken along line A-A of  FIG. 7B ; 
         FIG. 8A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having beads as a separate component; 
         FIG. 8B  is a side view of the device of  FIG. 8A ; 
         FIG. 8C  is a cross-sectional view taken along line A-A of  FIG. 8B ; 
         FIG. 8D  is a perspective view of the frame of  FIG. 8A ; 
         FIG. 8E  is an exploded view of the device of  FIG. 8A ; 
         FIG. 9A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having a distal edge frame; 
         FIG. 9B  is a side view of the device of  FIG. 9A ; 
         FIG. 9C  is a cross-sectional view taken along line A-A of  FIG. 9B ; 
         FIG. 10A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having an adjustable size and shown in the smaller configuration with the collar in the distal position with the equivalent perimeter of  FIG. 2A ; 
         FIG. 10B  is a side view of the device of  FIG. 10A ; 
         FIG. 10C  is a cross-sectional view taken along line A-A of  FIG. 10B ; 
         FIG. 10D  is a view similar to  FIG. 10A  showing the device in the larger configuration with the collar in the proximal position; 
         FIG. 10E  is a side view of the device of  FIG. 10D ; 
         FIG. 10F  is a cross-sectional view taken along line A-A of  FIG. 10E ; 
         FIG. 11A  is a plan view of another alternate embodiment of the intrauterine device of the present invention having an adjustable size and shown in the smaller configuration with the collar in the distal position with the equivalent perimeter of  FIG. 2D ; 
         FIG. 11B  is a side view of the device of  FIG. 11A ; 
         FIG. 11C  is a cross-sectional view taken along line A-A of  FIG. 11B ; 
         FIG. 11D  is a view similar to  FIG. 11A  showing the device in the larger configuration with the collar in the proximal position; 
         FIG. 11E  is a side view of the device of  FIG. 11D ; 
         FIG. 11F  is a cross-sectional view taken along line A-A of  FIG. 11E ; 
         FIG. 12A  is a plan view of an alternate embodiment of the intrauterine device of the present invention having a non-planar side profile and a convex distal edge (end); 
         FIG. 12B  is a side view of the device of  FIG. 12A ; 
         FIG. 12C  is a perspective view of the device of  FIG. 12A ; 
         FIG. 12D  is a plan view of the intrauterine device of  FIG. 12A  to illustrate various dimensions of the device; 
         FIG. 12E  is a longitudinal cross-sectional view taken along line B-B of  FIG. 12D ; 
         FIG. 12F  is a plan view of a larger size intrauterine device of  FIG. 12A ; 
         FIG. 12G  is a side view of the device of  FIG. 12C ; 
         FIG. 13A  is a plan view of the membrane support structure (frame) of the intrauterine device of  FIG. 12A ; 
         FIGS. 13B and 13C  are side views of the frame of  FIG. 13A ; 
         FIG. 13D  is a perspective view of the frame of  FIG. 13A ; 
         FIG. 13E  is a plan view of the frame of the intrauterine device of  FIG. 12F ; 
         FIG. 13F  is a side view of the frame of the intrauterine device of  FIG. 12F ; 
         FIG. 14  is a perspective view of the intrauterine device and the delivery system; 
         FIG. 15A  is a perspective view of the inner delivery tube of the delivery system of  FIG. 14 ; 
         FIG. 15B  is a plan view of the inner delivery tube of  FIG. 15A ; 
         FIG. 15C  is a front view of the inner delivery tube of  FIG. 15A ; 
         FIG. 16A  is a perspective view of the outer delivery tube of the delivery system of  FIG. 14 ; 
         FIG. 16B  is a front view of the outer delivery tube of  FIG. 16A ; 
         FIG. 16C  is a cross-sectional view taken along line A-A of  FIG. 16B ; 
         FIG. 16D  is a plan view of the inner delivery tube of  FIG. 16A ; 
         FIG. 17  is a perspective view of the intrauterine delivery device, the components of the delivery system and the packaging for the device and delivery components; 
         FIG. 18A  is a side view of the intrauterine device of  FIG. 12A  in a partially deployed position; 
         FIG. 18B  is a side view of the delivery system of  FIG. 14  with the inner tube in the retracted position; 
         FIG. 18C  is a view similar to  FIG. 18B  showing the inner delivery tube advanced within the outer tube to deploy the intrauterine device; and 
         FIG. 18D  is a view similar to  FIG. 18 c    showing the intrauterine device released from the delivery system. 
     
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
     The present invention provides non-hormonal intrauterine devices inserted into the uterine cavity to prevent egg fertilization. Various embodiments of the devices, as well as various sizes, are discussed in detail below. The intrauterine devices of the present invention provide a foreign body physical contact, and unlike copper or hormonal IUDs, are non-reactive and rely only on physical contact with the endometrium. The devices of the present invention provide increased surface area to fill the uterine cavity and better conform to the uterine cavity. 
     The devices of the present invention include a tail portion and a membrane or web that is inserted into the uterine cavity in a collapsed position and expands within the uterine cavity to fill a large space within the cavity. In some embodiments, a frame attached or embedded in the membrane causes expansion; in other embodiments the membrane itself is made of self-expanding material (referred to herein as “frameless”). Each of these versions is discussed in detail below. 
     The devices exert an expansive force to stretch from end to end of the uterus. The devices further exert a non-migratory force to prevent dislodgement. In preferred embodiments, the device can remain in the cavity for a five to ten year period, although other insertion time periods are also contemplated. 
     In some embodiments, the devices can come in two or more sizes. These are referred to herein as “non-adjustable” devices. In other embodiments, the device itself can be adjusted to two, or in some embodiments, more than two, sizes. These are referred to herein as “adjustable devices.” These adjustable and non-adjustable versions are discussed in detail below. 
     The frame for expanding the membrane (web) can be made of various materials such as stainless steel, e.g., 300 stainless steel, cobalt chrome or nickel titanium. The membrane can be made for example of ePTFE, textiles, silicone, urethane, polyurethane or siliconized polyurethane. Other materials to form the frame and membrane are also contemplated. The devices in preferred embodiments are not made of copper. 
     Preferred embodiments of the devices of the present invention have a soft coating to minimize trauma during insertion and long term placement. Preferred embodiments of the devices provide increased surface area to increase efficacy. These preferred embodiments are discussed in detail below. 
     The devices of the present invention advantageously satisfy the following parameters: 1) fill enough space in the uterine cavity to act as a blockade for eggs, i.e. prevent a fertilized egg from implanting in the wall by increasing the surface area of the membrane; 2) minimize patient discomfort; 3) are non-hormonal (inactive); and/or 4) are durable, e.g., can remain in the body for a number of years. 
     In some embodiments, the device can be resterilized and reinserted. 
       FIGS. 1A-1C  illustrate a prior art intrauterine device. The device has an expandable wire frame A, a stretchable membrane B supported by the frame A, beads C at the distal tips of the frame A, and a tail portion D. The intrauterine devices of the present invention are structurally and materially different and have usage and clinical advantages over the prior art device of  FIG. 1A . These features/differences of the present invention can be appreciated by the detailed discussion below of the various embodiments. 
     Note as used herein the term “proximal” denotes the component, region or portion closer to the user and the term “distal” denotes the component, region or portion further from the user. As used herein, the term “substantially” denotes a deviation of 15% of the numeric value. 
     Turning now to the drawings, and particular embodiments of the present disclosure, wherein like reference numerals identify similar structural features of the devices disclosed herein,  FIGS. 2A-2C  illustrate one embodiment of the intrauterine device of the present invention. The intrauterine device is designated generally by reference numeral  10  and has a tail portion  12  and an enlarged tube or sleeve  14  integral with the tail portion  12  or alternatively positioned over the tail portion  12  or alternatively attached to the tail portion  12  and extending distally therefrom. An expandable frame  16  extends from the sleeve  14  and a membrane  22  is attached to frame  16  and is expandable by the frame  16 . In some embodiments, sleeve  14  and membrane  22  are the same component, constructed of the same material; in other embodiments, they are composed of separate materials. At the tips of the frame  16  are distal beads  18 ,  20 . The device  10  is shown in  FIGS. 2A-2C  in an expanded position (condition). 
     The device  10  is inserted through an insertion tube or sleeve (not shown) with the wire frame  16  and membrane  22  in the collapsed position (condition). When exposed from the insertion tube, the frame  16  automatically expands to the expanded position (condition) shown in  FIGS. 2A-2C  to expand the membrane  22  within the uterine cavity. 
     The distal edge (end)  24  of membrane  22  is convex to provide additional surface area for the membrane  22  and to better conform to the uterine anatomy. The convex end as shown spans the width of the membrane from the first arm to the second arm. It should be appreciated that such convexity can be provided in the membranes or webs of the other embodiments disclosed herein. Note as used herein, the term “membrane” as discussed with respect to the various embodiments, denotes a material or structure that is positioned, e.g., spans an area, distal of the tail portion and configured to occupy sufficient space in the uterine cavity. Various structures and materials for the membrane, such as silicone, are discussed herein, but the membrane can be composed of other materials for placement within the cavity to perform the functions as described herein. 
     The frame  16  is V-shaped, with the vertex of the V at the proximal end connected to the enlarged tube  14  on tail portion  12 . The arms of the V terminate in curled distal tips or loops  25 ,  27 . The membrane  22  can extend to cover the wire loops  25 ,  27  to form distal beads  18 ,  20 . Note the loops  25 ,  27  are circular loops to create a spherical bead, however, it should be understood that loops and/or beads of different configurations, e.g., oval, rectangular with smooth edges, asymmetric configurations, etc. can be used instead, in this embodiment of  FIG. 2A  as well as in the other embodiments disclosed herein. The distal beads are placed adjacent the fallopian tubes. 
     The device  10 ′ of  FIGS. 2D-2F  is identical to device  10  of  FIG. 2A  except it is a larger size. Therefore, identical components have been designated with “prime” reference numerals, such that device  10 ′ has a tail portion  12 ′, a tube or sleeve  14 ′. an expandable frame  16 ′ with distal beads  18 ′.  20 ′ and a membrane  22 ′. 
     Various dimensions for devices  10  and  10 ′ are contemplated.  FIGS. 2G and 2H , and the table below, show one example of dimensions for the device  10  of  FIG. 2A  and  FIGS. 21 and 2J , and the table below, show one example of the dimensions for the device  10 ′ of  FIG. 2D . Note these dimensions are provided by way of example as other dimensions are also contemplated. Such device dimensions can also be applicable to the devices of the other embodiments disclosed herein. 
     Example—FIGS.  2 G- 2 I 
       
     
       
         
           
               
               
               
             
               
                   
               
               
                   
                 DESIGNATION 
                 DIMENSIONS 
               
               
                 FEATURE 
                 IN DRAWING 
                 (IN MILLIMETERS) 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 Overall length 
                 A1 
                 87.3 
               
               
                 Width at frame 
                 A2 
                 28 
               
               
                 Length of Frame 
                 A3 
                 37 
               
               
                 Length (to middle of bead 
                 A4 
                 34 
               
               
                   
               
            
           
         
       
     
     Example—FIGS.  2 J- 2 L 
       
     
       
         
           
               
               
               
             
               
                   
               
               
                   
                 DESIGNATION 
                 DIMENSIONS 
               
               
                 FEATURE 
                 IN DRAWING 
                 (IN MILLIMETERS) 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 Overall length 
                 B1 
                 96.3 
               
               
                 Width at frame 
                 B2 
                 34 
               
               
                 Length of Frame 
                 B3 
                 46 
               
               
                 Length(to middle of bead) 
                 B4 
                 43 
               
               
                   
               
            
           
         
       
     
     In the embodiment of  FIG. 2A , the frame wires are planar.  FIGS. 3A-5B  illustrate alternate embodiments wherein the wire(s) are non-planar (see side profile) which in some applications better match the anatomy. Device  30  of  FIG. 3A , like device  10  of  FIG. 2A , has a tail portion  32 , an enlarged tube or sleeve  34 , an expandable frame  36  with distal beads  38 ,  39  and a membrane  37  expanded by frame  36 . It has a non-planar side profile as shown in  FIG. 3B . The membrane  37  has a concave distal edge  37   a  which provides less surface area than the convex edge of membrane  22  discussed above. In alternate embodiments, the edge is convex. 
     The device of  FIGS. 12A-12E, 13A-13D  also has a non-planar side profile. Device  120 , like device  10  of  FIG. 2A , has a tail portion  122 , an enlarged tube or sleeve (barrel)  124 , an expandable V-shaped frame  126  with distal beads  128 ,  130  and a membrane  132  expandable by frame  126  with a convex distal edge  134  to increase surface area. The frame  126  extends from barrel  124  and is attached thereto as shown. The frame  126 , preferably a wire frame, has two arms  127  each extending from tube  124 , and each having a distal portion (region)  126   a , a proximal portion (region)  126   b  and an intermediate portion (region)  126   c  between the proximal and distal portions  126   b ,  126   a . The frame arms are non-linear and each has a curvature in the intermediate portion  126   c  so the intermediate portion  126   c  lies in a different plane than the distal portion  126   a  and in a different plane than the proximal portion  126   b . The distal and proximal portions can lie in the same plane or alternatively can be in different planes. Stated another way, the intermediate portion  126   c  extends radially with respect to the longitudinal axis of the device (see also  FIG. 12C ). The curvature increases the surface area of the attached membrane  132  as the membrane  132  is non-planer as an intermediate region curves inwardly in a concave manner due to the curvature of arms  127 . Thus, the intermediate region  132   a  of the membrane  132  lies in a different plane than the distal region  132   b  as shown in  FIG. 13C . Note that in  FIG. 12 a    a single curvature or arc is illustrated, however it is also contemplated that more than one curve can be provided for increased surface area. Also, the position of the curve with respect to the distal and proximal portions  126   a ,  126   b , length of the curve and size of the curve can vary from that shown. 
       FIGS. 12A, 12B, 12D .  12 E and  13 A- 13 C illustrate one example of dimensions of the intrauterine device of  FIG. 12A , and these dimensions are set forth in the chart below. It should be appreciated that other dimensions are also contemplated.  FIGS. 12F and 12G, 13E and 13F  illustrate a larger version of the device of  FIG. 12A . Device  140  is identical to device  120  and has a tail portion  142 , an enlarged tube or sleeve  144 , an expandable frame  146  with bent (curved) arms  147  and distal beads  148 ,  150  and a membrane  152  with a convex distal edge  154  to increase surface area. 
     The tables below provide examples of the dimensions of the device  120  and  140 , it being understood that other dimensions are also contemplated. 
     Example—FIG.  12 A Embodiment (Device  120 ) 
       
     
       
         
           
               
               
               
             
               
                   
               
               
                   
                 DESIGNATION 
                 DIMENSIONS 
               
               
                 FEATURE 
                 IN DRAWING 
                 (IN MILLIMETERS) 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 Overall length 
                 C1 
                 87.3 
               
               
                 Width at widest portion 
                 C2 
                 32 
               
               
                 Height 
                 C3 
                 4.12 
               
               
                 Tail length 
                 C4 
                 40 
               
               
                 Tail diameter 
                 C5 
                 1.5 
               
               
                 Frame length 
                 C6 
                 34 
               
               
                 Frame Height 
                 C7 
                 2.5 
               
               
                 Frame wire diameter 
                 C8 
                 .025 
               
               
                 Frame width span 
                 C9 
                 28 
               
               
                 (without coating) 
               
               
                 Barrel length 
                 C10 
                 17.78 
               
               
                 Barrel diameter 
                 C11 
                 3 
               
               
                 Bead diameter 
                 C12 
                 4 
               
               
                 Bead thickness&#39; 
                 C13 
                 2 
               
               
                 Frame diameter 
                 C14 
                 1.25 
               
               
                 Web thickness 
                 C15 
                 .5 
               
               
                 Arm Radius 
                 C16 
                 21.38 
               
               
                 Arm Radius 
                 C17 
                 49.75 
               
               
                   
               
            
           
         
       
     
     Example—FIG.  12 F Embodiment (Device  140 ) 
       
     
       
         
           
               
               
               
             
               
                   
               
               
                   
                 DESIGNATION 
                 DIMENSIONS 
               
               
                 FEATURE 
                 IN DRAWING 
                 (IN MILLIMETERS) 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 Overall length 
                 D1 
                 96.3 
               
               
                 Width at widest portion 
                 D2 
                 38 
               
               
                 Height 
                 D3 
                 5.12 
               
               
                 Tail length 
                 D4 
                 40 
               
               
                 Tail diameter 
                 D5 
                 1.5 
               
               
                 Frame length 
                 D6 
                 43 
               
               
                 Frame Height 
                 D7 
                 3.5 
               
               
                 Frame wire diameter 
                 D8 
                 .025 
               
               
                 Frame width span 
                 D9 
                 34 
               
               
                 (without coating) 
               
               
                 Barrel length 
                 D10 
                 17.78 
               
               
                 Barrel diameter 
                 D11 
                 3 
               
               
                 Bead diameter 
                 D12 
                 4 
               
               
                 Bead thickness 
                 D13 
                 2 
               
               
                 Frame diameter 
                 D14 
                 1.25 
               
               
                 Web thickness 
                 D15 
                 .5 
               
               
                 Arm Radius 
                 D16 
                 26.02 
               
               
                   
               
            
           
         
       
     
     The device  120  (and  140 ) can be formed by various methods such as i) overmolding the wire form (V-shaped frame) to match the shape of the wire form; ii) dip molding to match the shape of the wire form; or iii) not initially shaping the wire form and molding it in a flat configuration and bending it once coated. In this latter method, the loops can be formed at the end of the V but the arms are not bent out of the plane to increase to the D3 dimension until after overmolding (or dip molding). Note other manufacturing methods are also contemplated. 
     Device  40  of  FIG. 4A , like device  10  of  FIG. 2A , has a tail portion  42 , an enlarged tube or sleeve (barrel)  44 , an expandable V-shaped frame  46  with distal beads  48 ,  49  and a membrane  47  expandable by frame  46 . The frame  46 , as shown in the side profile of  FIG. 4B , has a planar arm  43  and a non-planar arm  45  with a gap  41  therebetween. Arm  45  is non-linear and has a curvature or bend as shown, forming a C-shape. The frame thus can have one or two straight arms  43  and one or two bent arms  45  which provide a bend in the attached membrane  47  so the membrane  47  extends inwardly in a concave manner to increase surface area. Arms  43  and  45  can be the same or separate components. Such configuration can add an anti-migratory force with thickness in addition to increasing the surface area of membrane  47 . Note the material (membrane) is removed from the view in  FIG. 4B  (and  FIG. 5B ) for clarity to show the frame configuration. 
     Device  50  of  FIG. 5A , like device  10  of  FIG. 2A , has a tail portion  52 , an enlarged tube or sleeve (barrel)  54 , an expandable frame  56  with distal beads  58 ,  59  and a membrane  57  expandable by frame  56 . It has two non-planar sides  53  and  55 . That is, frame  56  has multiple arms  57  which are bent to provide one or more bends/curves in membrane  57  so that membrane  57  extends in multiple planes. This structure can reduce migration and increase surface area. The sides  53 ,  55  can be the same or separate components and lie in a different plane than the distal and proximal portion of the frame  56 . With the arms in multiple planes, the membrane can extend around the top, both sides (gap between the arms) and bottom. That is, the membrane can be considered to have four panels (covers) extending between the arms—top panel, bottom panel and two side panels creating a more three dimensional membrane and thus surface area. Such four panels can also be provided between the arms in the device  40  of  FIG. 4A  to increase the surface area. 
     Device  120  and  140 , as well as the other devices disclosed herein, can be formed of a metal frame overmolded with silicone to form the membrane and beads. The membrane material can be radiopaque, e.g., can contain barium or other materials. The coating can also form the collar (barrel) and tail of the device. The silicone coating provides a softer less traumatic device with no sharp edges. The frame can be made of stainless steel, Nitinol (nickel-titanium alloy) or a material of sufficient springiness to self-expand to expand the membrane. It could also be made of shape memory Nitinol that transitions to its shape memorized condition (position) due to a change in temperature, e.g., exposure to body temperature or due to release of a constraining tube. The wire form can be made of radiopaque materials such as platinum and platinum iridium, tantalum and tantalum-tungsten and similar alloys in clad composite with 316LVM stainless steel, nitinol and MP35N. 
     The beads of  FIGS. 2A-5B  are shown as integral as the wire frame is looped at the distal ends of the arms, and the membrane attached thereover, to form the beads. In an alternate embodiment shown in  FIGS. 8A-8E , the beads  68 ,  69  of device  60  are separate components welded or attached by other methods to the non-looped distal ends of the expandable frame  62 . Making the beads as a separate component enables the beads to be made of a more radiologically opaque material to better locate them. In this embodiment, the wire frame  62  does not roll around to form the beads. The beads  68 ,  69  are preferably formed of a metallic material and attached to distal tips  64 ,  66  of the arms of the V-shaped wire frame  62 . The membrane  67  of device  60  is supported and expanded by the frame  62  and has a concave distal edge rather than a convex edge, although alternatively, the distal edge can be convex. Note such concave edge can be provided in the membranes or webs of the other embodiments disclosed herein. In all other respects, device  60  is the same as device  10 , with the wire frame  62  extending from barrel  63  on tail portion  61  and expandable into the aforedescribed V-shape to spread the membrane  67  when exposed from the insertion tube as described herein. It should be appreciated that the beads as a separate component (or alternatively as integral with the wire frame) can be utilized in any of the embodiments described herein. 
     In the foregoing embodiments, the wire frame forms a V-shape and is attached to or positioned. e.g., embedded in, sides of the membrane such as by overmolding. That is, the two arms of the “V” extend distally and radially outwardly from the barrel to extend through and/or support opposing side edges of the membrane. (The membrane can be attached to an outer surface of the arms or the arms can be embedded in the membrane). In an alternate embodiment, the wire frame is positioned only along a distal edge of the membrane and not on the side edges. This is shown for example in  FIGS. 9A-9C . Wire frame  76  of device  70  is spaced distally and unattached to barrel  74  on tail portion  72  and provides the expansive force as it extends horizontally (transverse) to a longitudinal axis of the device. It extends across the distal region or distal edge of membrane  77  and has looped ends  80 ,  82  forming, with the membrane, beads  78 ,  79 . (The membrane  77  can be attached to an outer surface of the wire  76  or the wire  76  can be embedded in the membrane  77 ). The frame  76  bends inwardly as shown to provide the membrane  77  with a concave distal edge, however, in alternate embodiments to increase surface area, it can bend outwardly to provide the membrane  77  with a convex distal edge. 
     When inside the insertion tube, the wire  76  of device  70  is collapsed to a narrow U or V-shape, with the two “arms” of the U extending substantially parallel. When exposed from the delivery device, the frame  76  expands to the curved position shown. In an alternate embodiment, instead of the wire, the membrane itself can have a reinforced distal edge to provide the expansive force on the membrane to expand the membrane. It should be appreciated that the wire supporting the side edges, the wire supporting the distal edge and the wireless version can be utilized in any of the various membrane embodiments disclosed herein. It should also be appreciated that other shaped wire frames, e.g., extending along the sides and the distal edge, forming a triangular configuration or closed loop, or at other regions of the membrane are also contemplated for the various devices disclosed herein. 
     In the foregoing embodiments, expandable wire frames are utilized to expand the membrane thereby providing an outward force to anchor the beads. In alternate embodiments, devices without frames (“frameless devices”) are provided, relying on the material itself to expand when exposed from the insertion (delivery) tube to provide the outward force to spread and to anchor the beads. This is shown for example in  FIGS. 6A-6C . Frameless device  80  has a membrane  82 , also referred to as a web, in the form of a folding fan, with the folding hinges of the fan applying the expansive force. The membrane  82  is inserted in the collapsed position (condition) through an insertion (delivery) sleeve or tube and when exposed from the sleeve expands to the expanded condition shown in  FIG. 6A . Beads  88 ,  89  are integrated into the web  82  or alternatively attached to the web  82  at the distal outer ends. The web  82  can be composed of shape memory metal such as nitinol or shape memory polymer with a shape memorized expanded position which can transition in response to temperature change or removal of a constraint, e.g., a delivery tube. For example it can be laser cut out of a Nitinol sheet and shape set in a fan. Other self-expanding materials are also contemplated. The web  82  can be overmolded with a material such as silicone to smooth it. The edges of the web  82  can be rolled to smooth out the edges. In some embodiments, it could be pleated. Device  80  has an enlarged tube (barrel)  86  on tail portion  84  similar to tail portion  12  and barrel  14  of  FIG. 2A . The web  82  has a concave distal edge  83  as shown but alternatively can have a convex distal edge as in  FIG. 12A . 
       FIGS. 7A-7C  illustrate an alternate embodiment of a frameless design. Device  90  has a mesh  96  extending distally of enlarged sleeve (barrel)  94  of tail portion  92 . The meshed web  96  creates an expansive force. Beads  98 ,  99  are integrated into the web  96  or alternatively attached to the web  96  at the distal outer ends. The membrane overlays the mesh either by fusing to the web or laying it overtop the mesh (unfused). For example a silicone or urethane can overlay the mesh, surrounding the mesh in a sock-like fashion. Note the border of the mesh, i.e., the side edges, are depicted in darker lines (a hard border) for clarity to depict the outline of the mesh. The line can also be considered to depict the termination of the loose end of the mesh in some embodiments. The web  96  has a concave distal edge  93  as shown but alternatively can have a convex distal edge as in  FIG. 12A . 
     Note the frameless devices  80  and  90 , as well as the other devices disclosed herein, can have a non-planar frame as in the embodiments of  FIGS. 3B, 4B, 5B and 12B . 
     The foregoing devices can be provided in different sizes. e.g., different lengths of the tail portion, different widths of the expanded membrane, etc. The present invention also provides devices of adjustable web sizes so the clinician can adjust the device as desired to accommodate varied uterus anatomy. Two examples of expandable devices are shown in  FIGS. 10A-11F . Although  FIGS. 10-11F  appear to have smaller webs/membranes, this is for clarity. The devices of  FIGS. 10A-11F  can have equivalent membrane surface area to the aforementioned devices. The devices can also have non-planar frames as in the devices discussed above. 
     Turning first to the embodiment of  FIGS. 10A-10C , device  110  has a tail portion  112 , an enlarged tube or sleeve (barrel)  114  positioned over the tail portion  112 , an expandable frame  116  extending from the sleeve  114  and a membrane  122  expandable by the frame  116 . At the tips of the frame  114  are distal beads  118 ,  120 . 
     An adjustable collar  115 , having a lumen to receive the wire frame  116 , is slidable along the wire  116  between two positions. The collar  115  is shown in  FIGS. 10A-10C  in the distal position and in  FIGS. 10D-10F  in the proximal position. The device  110  is shown in  FIGS. 10A-10C  in a first smaller expanded position (condition) corresponding to the collar  115  being in the distal position. The device  110  is inserted through an insertion tube or sleeve (not shown) with the wire frame  116  and membrane  122  in the collapsed position (condition) and when exposed from the insertion tube, the frame  116  automatically expands to the smaller expanded condition shown in  FIGS. 10A-10C  to expand the membrane  122  since the collar  115  is in the distal position. 
     If a larger size membrane/web is desired, with a larger transverse dimension to cover increased area within the uterine cavity, the collar  115  is retracted to the proximal position of  FIGS. 10D-10F . Such retraction releases more of the wire frame (region  116   a ) allowing the arms  116   b .  116   c  of the wire frame  116  to open in a longer and wider “V” to provide a second expanded position. The wire frame  116  has proximal and distal looped regions  117 ,  119  respectively, to act as stops for the adjustable collar  115 . That is, when the adjustable collar  115  is in the distal position, the distal looped region  119  prevents proximal movement of the collar  115  unless a sufficient proximal force is applied to override the distal looped region  117 . When the collar  115  is in the proximal position, proximal looped region  117  limits proximal movement of the collar  115  and distal looped region  119  limits distal movement of the collar  115  unless a sufficient distal force is applied to the collar  115  by the clinician to override the loop region  119  and move the frame  116  and membrane  122  to the smaller expanded position of  FIG. 10A . Thus, prior to insertion into the uterine cavity, the user can place the collar  115  in the desired position for small or large applications. In either position, the device  110  is inserted through an insertion tube or sheath with the wire frame  116  and membrane  122  in the collapsed insertion position. When exposed from the sheath, the frame  116  expands to either the first expanded position or the second expanded position, depending on the preset position of the collar  115 . The device  110  in some embodiments can include an extension extending proximally form the collar  115 , such as a tube, that is accessible to the clinician at a proximal region when the device  110  is inserted in the uterine cavity. This would enable adjustment of the size of the device  110  by movement of the collar  115  when the device  110  is already positioned within the uterine cavity or pre-insertion. The device  110  can be packaged with the collar  115  in either the distal or the proximal position. 
     The device of  FIG. 10A  can for example be of a length of 96 mm, although other lengths are contemplated. Note that in this embodiment, the length from the beads  118 ,  120  to the tail is relatively small. Thus, it has a shorter frame and a shorter membrane. In the embodiment of  FIGS. 11A-11F , the device  110 ′ is identical to device  110  of  FIG. 10A  except it has a longer length in the collapsed position (and expanded position) from the beads  118 ′,  120 ′ to the tail. The length of the distal collar position is the same in device  110 ′ as in device  110  and the length of the proximal collar position is the same in device  110 ′ as device  110 ′. The length of device  110 ′ can be the same overall length as device  110 . Since in all other respects, device  110 ′ is the same as device  110 , the identical components/features have been designated with “prime” reference numerals, e.g., adjustable collar  115 ′, tail portion  112 ′, frame  116 ′ beads  118 ′,  120 ′, membrane  122 ′, etc. 
     Note that although two positions are shown, it is also contemplated that the collar can have more than two positions to provide more than two expanded positions of the wire and membrane to provide more than two sizes in the single device. 
     It should be appreciated that the adjustable collar of  FIG. 10A  can be provided on any of the devices described herein to adjust the size of the device. 
     The devices disclosed herein are not made of copper or a reactive material and thus do not act like a drug. They are designed to fill the uterine cavity and provide increased surface area. They are preferably flexible to better fill the cavity. The beads do not necessarily need to be configured or positioned to block the fallopian tubes. 
     A delivery system for the herein described intrauterine devices of the present invention is shown in  FIGS. 14-16D . The delivery system includes an outer delivery tube  160  and an inner delivery tube  170  slidable received in the lumen  161  of the outer tube  160 . Outer tube  160 , as shown in  FIGS. 16A-16C  includes a collar or stop  162  to limit proximal and/or distal movement via contact with the patient&#39;s body. The outer tube can have a tapered distal portion  163 . 
     Inner tube  170 , as shown in  FIGS. 15A-15C  has slot (or slit)  172  at a distal end dimensioned to receive the tail portion of the intrauterine device. The device is positioned in the elongated slot  172  such that the tail is retained by the inner tube  170  and the frame and membrane of the device extend distally of the distal edge  174  of the inner tube  170 . When the outer tube  160  overlies the slot  172  of the inner tube  170 , the tail portion is retained: when the outer tube  160  is retracted relative to the inner tube  170  (or the inner tube  170  is advanced relative to the outer tube or both the inner tube  170  advanced and the outer tube  160  retracted), the tail portion is exposed for release of the intrauterine device into the uterine cavity. A sample packaging for the intrauterine device and delivery system is shown in  FIG. 17  which has a lower tray  180  and upper lid  182 . The packaging can also include a uterine sound  189  used to examine the vaginal cavity and measure the depth of the uterus. The intrauterine device can be packaged adjacent but non-engaged with the slot of the inner tube. Alternatively, the device could be packaged with the tail portion positioned in the slot, i.e., preloaded. If packaged as shown in  FIG. 17 , the device is in the placement (unconstrained) position. The intrauterine device shown in  FIG. 17  is device  120  of  FIG. 12A , however, the other uterine devices disclosed herein could alternatively be packaged and used with the delivery system. 
     In use, the tail  122  of the uterine device  120  is initially placed within the slot  172  in the inner tube  170  (if not packaged within the slot). The inner tube  170  is pulled back within the outer tube  160  to collapse the frame  126  and membrane  132  for delivery into the uterine cavity. This position is shown in  FIG. 18A  wherein the frame  120  is within the outer tube  160  with only the beads  128 ,  130  exposed. Once inserted in the uterine cavity, relative movement of the inner tube  170  and outer tube  160 , e.g., pulling the outer tube  160  back or moving the inner tube  170  forward, exposes the slot  172  and tail portion  122  and enables self-expansion of the frame  126  and membrane  132  to release the device from the delivery system as shown in  FIGS. 18A and 18C  wherein the device  120  is partially deployed as it is exposed and then fully deployed for release as in  FIG. 18D . 
     Although the apparatus and methods of the subject invention have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present invention as defined by the appended claims.