Title:
INTRA UTERINE DEVICE AND INJECTOR THEREOF
United States Patent 3678927
Abstract:
The present disclosure relates to an intra uterine device and a means for injecting the device into the uterine cavity with assurance that there will be no harm to the interior tissues and with the further assurance that it will be properly injected without injury to the user and with assurance that it will be in proper position. The intra uterine device consists of two outwardly springing inert metal wires, such as chromium alloy wires, nickel alloy wires, or preferably stainless steel wires turned inwardly at their outer ends to form loops, or ended with a small engagement, which tend to spring apart and are joined at their base portions to form a Y-shaped structure.
US Patent References:
Intrauterine device
Birnberg et al. - May 1966 - 3253590
Contraceptive intra-uterine devices
Hulka et al. - October 1968 - 3407806
INTRA-UTERINE DEVICE
Soichet - April 1970 - 3507274
Intrauterine device
Birnberg et al. - May 1966 - 3253590
Contraceptive intra-uterine devices
Hulka et al. - October 1968 - 3407806
INTRA-UTERINE DEVICE
Soichet - April 1970 - 3507274
Application Number:
05/005466
Publication Date:
07/25/1972
Filing Date:
01/26/1970
View Patent Images:
Export Citation:
Primary Class:
International Classes:
A61F6/14; A61F6/00; A61F5/46
Field of Search:
128/130-132
Primary Examiner:
Charles, Lawrence
Parent Case Data:
The present application is a continuation in part of application Ser. No. 713,825, filed Mar. 18, 1968, now U.S. Pat. No. 3,507,274, issued Apr. 21, 1970.
Claims:
What is claimed is
1. An intra-uterine device comprising:
1. An intra-uterine device comprising:
Description:
The Y-shaped basic wire structure of stainless steel or similar inert resilient material is desirable of a single piece of metal which is bent back upon itself at the junction so as to permit the divergent Y-shaped members to be pressed together by having the wires at the junction cross each other when the two divergent legs are bent together.
The upper and lower ends of the wire device are coated with silicone rubber or other suitable thermoplastic material and connected to a silicone rubber extension which loosely hangs down from the opening of the uterus and serves as a means for ascertaining whether the device is in place and also for removing the same.
The device may less preferably be molded entirely of a thermoplastic material with the two divergent arms ending in enlarged portions being integral with the lower extending junction stem. In this case an opening may be provided in the junction stem to receive a wire of an inert material, which then could extend downwardly and serve to remove the device and also determine whether it is in place.
In addition to or in lieu of silicone rubber, it is possible to use polyethelene, polypropylene, nylon, or a plastic such as Delrin 900 put out by Du Pont Co.
The injector is designed to receive the intra uterine device with the end portions projecting beyond the end of the injector and serving as a means of convenient entrance without injuring the tissues. The limit of injection is fixed by a round collar or other projection on the injector device.
The injector may have an outer tubular element to receive the device and an inside piston element to inject the device, with the piston element also useful if desired as a dilator to be used to dilate the mouth of the womb.
DESCRIPTION OF THE INVENTION
It has been found most satisfactory to form the device of resilient or spring-like short wires of an inert metal, such as stainless steel, which are joined together by bending, by soldering, by welding or other joining at a lower end portion and then extending upwardly and diverging from one another into outwardly and then inwardly turned loops or with a small metal engagement on each tip.
These loops are designed to receive and be embodied in plastic beads, such as silicone rubber beads or polyethylene beads or polypropylene beads, which are flat on the sides toward one another and curved outwardly or wedge-shaped on the separated or outer side so that when the legs are pressed together there will be a smooth elongated ovular end portion which may be readily inserted in the entrance or mouth of the uterine cavity.
These divergent inert metal legs are preferably coated with a plastic, but may be left uncoated. The plastic may be applied by means of tubular members or squeezed by a mold therein which are applied to the wires and sealed together at the junction and beaded over the inturned upper ends thereof.
From the junction of the two wires downwardly a flexible rod or strip of plastic may extend substantially from within the cavity through the cervix and to within the vagina, so that it may be readily contacted or grasped between the fingers to ascertain whether the device is in position and also to serve as a means of removal when desired without interfering otherwise with the bodily function.
The injector desirably consists of an elongated outer tube with a collar adjacent the inlet or injection end thereof extending outwardly therefrom to limit the injection and with the entire diameter of the tube being of sufficient dimension or diameter to receive the downwardly extending appendage as well as the upwardly extending wires when pressed together, receiving the end portions to form a smooth, rounded member for insertion through the cervix of the womb cavity, which will be limited by the adjacent cover projecting outwardly from the tubular member shortly below the mouth thereof.
The inside piston member which fits in and reciprocates within the elongated outer tube may be hollow so as to receive the downwardly extending appendage. The inner piston member may also have an enlarged finger pressed portion which may be screwed or jammed on.
BRIEF DESCRIPTION OF DRAWINGS
With the foregoing and other objects in view, the invention consists of the novel construction, combination and arrangement of parts as hereinafter more specifically described, and illustrated in the accompanying drawings, wherein is shown an embodiment of the invention, but it is to be understood that changes, variations and modifications can be resorted to which fall within the scope of the claims hereunto appended.
In the drawings wherein like reference characters denote corresponding parts throughout the several views:
FIG. 1 is an elongated longitudinal side sectional view of the injector, with the intra uterine device in position before injection.
FIG. 2 is a diagrammatic side elevational view showing the intra uterine device in position in the body organ after injection.
FIG. 3 is an enlarged side sectional view showing the uterine device after injection.
FIG. 4 is a diagrammatic top side elevational view of an alternative form of a completely molded or cast flexible plastic device with a trailing or depending wire member.
Referring to FIGS. 1 and 2, there is the uterus A having the body portion B and the cervix or mouth portion C. The passageways D lead to the Fallopian tubes, which in turn lead to the ovaries. The intra uterine device E has the upper portion F and the tail portion G. The injector H receives the tail portion G in its intermediate portion J and the portion F in the upper portion K, which is inserted into the cervix C.
The upper portion K and the lower portion J form the barrel of the injector H and this barrel carries the plunger L having the manual actuator M. Referring particularly to FIG. 3, the intra uterine device E consists of the stainless steel inert metal or wires 20 which terminate in the outwardly turned portions 21, which are turned inwardly at 22.
The ends 23 are embedded in rounded plastic portions 24 of silicone rubber, polyethylene, nylon or Delrin 900 put out by Du Pont Co., which, as indicated at 25, extend substantially beyond the turned-in portion 21. The inside faces of the enlarged portions 24 are flat, as indicated at 26, so that these two enlarged drop-like half-rounded portions 24 may be brought closely together and form an ellipsoidal shaped member, as indicated at 27 in FIG. 1.
The lower portions 27a serve as a wedge to enable the member 27 to be wedged into the mouth or outer end of the plunger barrel K so that it will not tend to separate until injection of the tube into the cavity 29.
The outside faces 28 of the enlarged portions 24 will contact the side wall 29 of the interior 30 of the cavity of the uterus A below the channels or openings D to the Fallopian tubes (see FIG. 2).
The divergent Y-shaped wires 20 meet at a junction 70 and they are bent to contact each other at 71 and terminate in a U-shaped bend at 72, and they may be coated for a distance above the bend junction 72 so as not to interfere with the bending together of the wires 71. When the wires are bent together the corners 73 will cross each other but after they are released inside of the body organ, as indicated in FIG. 2, they will resume the formation as shown in FIG. 3.
The divergent portions of the wires 20, as indicated in FIGS. 2 and 3, may be uncoated, although in some instances they may be coated entirely to the tips 25. However, the lower portion of the contacting wires 71 may be coated for a distance above the bent integral junction 72. The coating or film 31 may be of silicone rubber, nylon, polyethylene, polypropylene, or Delrin 900.
Desirably the plastic coating should terminate at 32, slightly below the lower end of the beads 25. The coating which extends around the junction as indicated at 72 may be pressed or squeezed onto the lower portion of the contacting wires 71 so that the bending or passing of the bent portions 73 across each other will not tend to rip or destroy the junction of the rubber 32 to the lower portions of the contacting wires 71.
Integrally connected to the covering 31 at the bend 72 will be the extension or appendage 39 which may be solid and is desirably of a smaller diameter than the diameter of the combined bend 72 and covering 31, as indicated at the junction of FIG. 3. Where the extension G is tubular, this end may be sealed as at 40 in FIG. 2.
This injected device E, when inserted, should take the position as indicated in FIG. 2, with the junction 34 being above the mouth or cervix and with the tail tube G extending downwardly from the cervix into the vagina, where it may be located or grasped, indicating that the device is in position and also permitting its ready removal when desired.
The insertion of the device E is accomplished by means of the injector H. The injector H has a barrel portion K-J, which is designed loosely to receive the tail G when the tubular plunger L is withdrawn. Where the tubular plunger may also readily receive the appendage or tail G, the appendage or tail G may be telescoped thereinto at the upper end thereof.
The upper portion of the barrel K-J receives an outstanding circular flange 50, which will be positioned so that the distance thereof from the upper end portion 51 will be somewhat less than the distance from the junction 34 to the upper end of the stainless steel wires 20.
The collar 50 is designed to contact the lower face 52 of the uterus A and limit the insertion of the upper portion K of the barrel. Although the tail G is placed loosely in the barrel K and in the tubular member L, the upper portion F consisting of the resilient wires 20 is forced into the upper portion K of the barrel K-J until the lower faces 27a of the enlarged plastic portions 24 jam inside the upper rounded edges 51 in the position shown in FIG. 1.
The tubular plunger L, when removed from the barrel member K-J, may be used as a dilator of the internal os of the curved cervix, which separates the cervical canal from the cavity of the uterus 30.
The middle portion of the barrel J continues to the lower cylindrical flange 54, which is at the end of the lower barrel J. The plunger L fits closely within the lower portion J and its lower end 55 is connected by means of the sleeve 56 to the disc 57, forming the manual actuator M. The sleeve 56 may be jam-fitted or screw-fitted onto the lower end 55 of the plunger member L. In the position shown in FIG. 1, the upper end 58 of the plunger L should contact the enlarged junction 26,34. In this position the injector H may be inserted so that the barrel portion K will fit in through the cervix C until the collar or flange 50 contacts the lower faces 52 of the uterus A.
The two body portions 24 forming the ellipsoidal portion 27 may be readily inserted through the cervix C. When this is accomplished, the plunger L will be pressed upwardly by placing the thumb under the disc M and the second and third fingers above the disc 54, following which the entire device E will be injected into the cavity 30 into the position as shown in FIG. 2, with the enlarged portions 24 contacting the walls 29 just below the entrance to the Fallopian tubes.
In FIG. 4 there is shown a molded plastic member M having the ellipsoidal end piece N, the springing Y-members P and the junction member Q. The junction member Q has a short tail R and an opening S. Through S extends a flexible loose inert metal wire T which can be used for the same purposes as the tail G in FIGS. 2 and 3. In FIG. 4 the device is desirably molded of a thermoplastic material, such as one of the resins above mentioned and it may be entirely coated with silicone rubber, if desired.
As many changes could be made in the above intra uterine device and injector thereof, and many widely different embodiments of this invention could be made without departure from the scope of the claims, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense.
The upper and lower ends of the wire device are coated with silicone rubber or other suitable thermoplastic material and connected to a silicone rubber extension which loosely hangs down from the opening of the uterus and serves as a means for ascertaining whether the device is in place and also for removing the same.
The device may less preferably be molded entirely of a thermoplastic material with the two divergent arms ending in enlarged portions being integral with the lower extending junction stem. In this case an opening may be provided in the junction stem to receive a wire of an inert material, which then could extend downwardly and serve to remove the device and also determine whether it is in place.
In addition to or in lieu of silicone rubber, it is possible to use polyethelene, polypropylene, nylon, or a plastic such as Delrin 900 put out by Du Pont Co.
The injector is designed to receive the intra uterine device with the end portions projecting beyond the end of the injector and serving as a means of convenient entrance without injuring the tissues. The limit of injection is fixed by a round collar or other projection on the injector device.
The injector may have an outer tubular element to receive the device and an inside piston element to inject the device, with the piston element also useful if desired as a dilator to be used to dilate the mouth of the womb.
DESCRIPTION OF THE INVENTION
It has been found most satisfactory to form the device of resilient or spring-like short wires of an inert metal, such as stainless steel, which are joined together by bending, by soldering, by welding or other joining at a lower end portion and then extending upwardly and diverging from one another into outwardly and then inwardly turned loops or with a small metal engagement on each tip.
These loops are designed to receive and be embodied in plastic beads, such as silicone rubber beads or polyethylene beads or polypropylene beads, which are flat on the sides toward one another and curved outwardly or wedge-shaped on the separated or outer side so that when the legs are pressed together there will be a smooth elongated ovular end portion which may be readily inserted in the entrance or mouth of the uterine cavity.
These divergent inert metal legs are preferably coated with a plastic, but may be left uncoated. The plastic may be applied by means of tubular members or squeezed by a mold therein which are applied to the wires and sealed together at the junction and beaded over the inturned upper ends thereof.
From the junction of the two wires downwardly a flexible rod or strip of plastic may extend substantially from within the cavity through the cervix and to within the vagina, so that it may be readily contacted or grasped between the fingers to ascertain whether the device is in position and also to serve as a means of removal when desired without interfering otherwise with the bodily function.
The injector desirably consists of an elongated outer tube with a collar adjacent the inlet or injection end thereof extending outwardly therefrom to limit the injection and with the entire diameter of the tube being of sufficient dimension or diameter to receive the downwardly extending appendage as well as the upwardly extending wires when pressed together, receiving the end portions to form a smooth, rounded member for insertion through the cervix of the womb cavity, which will be limited by the adjacent cover projecting outwardly from the tubular member shortly below the mouth thereof.
The inside piston member which fits in and reciprocates within the elongated outer tube may be hollow so as to receive the downwardly extending appendage. The inner piston member may also have an enlarged finger pressed portion which may be screwed or jammed on.
BRIEF DESCRIPTION OF DRAWINGS
With the foregoing and other objects in view, the invention consists of the novel construction, combination and arrangement of parts as hereinafter more specifically described, and illustrated in the accompanying drawings, wherein is shown an embodiment of the invention, but it is to be understood that changes, variations and modifications can be resorted to which fall within the scope of the claims hereunto appended.
In the drawings wherein like reference characters denote corresponding parts throughout the several views:
FIG. 1 is an elongated longitudinal side sectional view of the injector, with the intra uterine device in position before injection.
FIG. 2 is a diagrammatic side elevational view showing the intra uterine device in position in the body organ after injection.
FIG. 3 is an enlarged side sectional view showing the uterine device after injection.
FIG. 4 is a diagrammatic top side elevational view of an alternative form of a completely molded or cast flexible plastic device with a trailing or depending wire member.
Referring to FIGS. 1 and 2, there is the uterus A having the body portion B and the cervix or mouth portion C. The passageways D lead to the Fallopian tubes, which in turn lead to the ovaries. The intra uterine device E has the upper portion F and the tail portion G. The injector H receives the tail portion G in its intermediate portion J and the portion F in the upper portion K, which is inserted into the cervix C.
The upper portion K and the lower portion J form the barrel of the injector H and this barrel carries the plunger L having the manual actuator M. Referring particularly to FIG. 3, the intra uterine device E consists of the stainless steel inert metal or wires 20 which terminate in the outwardly turned portions 21, which are turned inwardly at 22.
The ends 23 are embedded in rounded plastic portions 24 of silicone rubber, polyethylene, nylon or Delrin 900 put out by Du Pont Co., which, as indicated at 25, extend substantially beyond the turned-in portion 21. The inside faces of the enlarged portions 24 are flat, as indicated at 26, so that these two enlarged drop-like half-rounded portions 24 may be brought closely together and form an ellipsoidal shaped member, as indicated at 27 in FIG. 1.
The lower portions 27a serve as a wedge to enable the member 27 to be wedged into the mouth or outer end of the plunger barrel K so that it will not tend to separate until injection of the tube into the cavity 29.
The outside faces 28 of the enlarged portions 24 will contact the side wall 29 of the interior 30 of the cavity of the uterus A below the channels or openings D to the Fallopian tubes (see FIG. 2).
The divergent Y-shaped wires 20 meet at a junction 70 and they are bent to contact each other at 71 and terminate in a U-shaped bend at 72, and they may be coated for a distance above the bend junction 72 so as not to interfere with the bending together of the wires 71. When the wires are bent together the corners 73 will cross each other but after they are released inside of the body organ, as indicated in FIG. 2, they will resume the formation as shown in FIG. 3.
The divergent portions of the wires 20, as indicated in FIGS. 2 and 3, may be uncoated, although in some instances they may be coated entirely to the tips 25. However, the lower portion of the contacting wires 71 may be coated for a distance above the bent integral junction 72. The coating or film 31 may be of silicone rubber, nylon, polyethylene, polypropylene, or Delrin 900.
Desirably the plastic coating should terminate at 32, slightly below the lower end of the beads 25. The coating which extends around the junction as indicated at 72 may be pressed or squeezed onto the lower portion of the contacting wires 71 so that the bending or passing of the bent portions 73 across each other will not tend to rip or destroy the junction of the rubber 32 to the lower portions of the contacting wires 71.
Integrally connected to the covering 31 at the bend 72 will be the extension or appendage 39 which may be solid and is desirably of a smaller diameter than the diameter of the combined bend 72 and covering 31, as indicated at the junction of FIG. 3. Where the extension G is tubular, this end may be sealed as at 40 in FIG. 2.
This injected device E, when inserted, should take the position as indicated in FIG. 2, with the junction 34 being above the mouth or cervix and with the tail tube G extending downwardly from the cervix into the vagina, where it may be located or grasped, indicating that the device is in position and also permitting its ready removal when desired.
The insertion of the device E is accomplished by means of the injector H. The injector H has a barrel portion K-J, which is designed loosely to receive the tail G when the tubular plunger L is withdrawn. Where the tubular plunger may also readily receive the appendage or tail G, the appendage or tail G may be telescoped thereinto at the upper end thereof.
The upper portion of the barrel K-J receives an outstanding circular flange 50, which will be positioned so that the distance thereof from the upper end portion 51 will be somewhat less than the distance from the junction 34 to the upper end of the stainless steel wires 20.
The collar 50 is designed to contact the lower face 52 of the uterus A and limit the insertion of the upper portion K of the barrel. Although the tail G is placed loosely in the barrel K and in the tubular member L, the upper portion F consisting of the resilient wires 20 is forced into the upper portion K of the barrel K-J until the lower faces 27a of the enlarged plastic portions 24 jam inside the upper rounded edges 51 in the position shown in FIG. 1.
The tubular plunger L, when removed from the barrel member K-J, may be used as a dilator of the internal os of the curved cervix, which separates the cervical canal from the cavity of the uterus 30.
The middle portion of the barrel J continues to the lower cylindrical flange 54, which is at the end of the lower barrel J. The plunger L fits closely within the lower portion J and its lower end 55 is connected by means of the sleeve 56 to the disc 57, forming the manual actuator M. The sleeve 56 may be jam-fitted or screw-fitted onto the lower end 55 of the plunger member L. In the position shown in FIG. 1, the upper end 58 of the plunger L should contact the enlarged junction 26,34. In this position the injector H may be inserted so that the barrel portion K will fit in through the cervix C until the collar or flange 50 contacts the lower faces 52 of the uterus A.
The two body portions 24 forming the ellipsoidal portion 27 may be readily inserted through the cervix C. When this is accomplished, the plunger L will be pressed upwardly by placing the thumb under the disc M and the second and third fingers above the disc 54, following which the entire device E will be injected into the cavity 30 into the position as shown in FIG. 2, with the enlarged portions 24 contacting the walls 29 just below the entrance to the Fallopian tubes.
In FIG. 4 there is shown a molded plastic member M having the ellipsoidal end piece N, the springing Y-members P and the junction member Q. The junction member Q has a short tail R and an opening S. Through S extends a flexible loose inert metal wire T which can be used for the same purposes as the tail G in FIGS. 2 and 3. In FIG. 4 the device is desirably molded of a thermoplastic material, such as one of the resins above mentioned and it may be entirely coated with silicone rubber, if desired.
As many changes could be made in the above intra uterine device and injector thereof, and many widely different embodiments of this invention could be made without departure from the scope of the claims, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense.