Abstract
A new and improved hybrid framed-frameless copper-releasing contraceptive device (IUD) which is a combination of a plastic retention arm of reduced dimensions to adapt to uterine cavities of smaller size, particularly regarding their transverse width at the fundal level of the uterus, and whose retention arm has a centrally located extension of varying length to be connected with hollow copper tubes which functions as the frameless stem of the IUD, and which consists of loosely connected hollow tubes, threaded on a length of suture, or a thin plastic or metallic stem, or a thin polymeric drug eluting stem, allowing release of copper ions, from the outside and from the inside of the tubes, in the uterine cavity thereby enhancing the contraceptive effect, and of which the bottom tube, is crimped onto the lower end of the stem, including a separate metallic ion-releasing fiber, holding all copper tubes together.
Claims
1. A framed-frameless, copper-releasing contraceptive device, said device comprising: a flexible plastic stem, an outside diameter of said stem being between 0.3 and 1.2 mm; a flexible plastic retention arm connected to said stem; hollow, copper tubes loosely threaded about said stem, said copper tubes comprising a proximal copper tube and a distal copper tube, wherein said stem has the outside diameter sufficiently smaller than an internal diameter of the copper tubes to allow release of copper ions from an outside as well as from an inside of the copper tubes, the copper tubes being freely rotatable around the stem, the copper tubes being freely movable up and down the stem; and an extension centrally provided on the retention arm, said extension being provided with the proximal copper tube of said stem.
2. The device according to claim 1, wherein an effective copper surface area of said device is 260 to 280 mm.sup.2.
3. The device according to claim 2, wherein said extension is no longer than a length of said proximal copper tube.
4. The device according to claim 1, wherein said proximal copper tube and said extension frictionally engage.
5. The device according to claim 1, wherein said proximal copper tube is crimped onto said extension.
6. The device according to claim 1, wherein said extension is no longer than a length of said proximal copper tube.
7. The device according to claim 1, wherein the copper tubes are separated from each other.
8. The device according to claim 1, wherein a lower end of said stem is provided with a thickening portion that keeps the copper tubes from sliding off said stem, and further comprising a tail tied to the lower end of said stem, the tail being for removal of said device.
9. The A device according to claim 1, wherein said retention arm and said stem constitute a frame of the device.
10. The device according to claim 1, wherein a length of the retention arm is no longer than 28 mm.
11. The device according to claim 1, wherein the retention arm is multi-segmented and thereby adaptable to different sizes and volume changes of a uterine cavity.
12. The device according to claim 1, wherein the retention arm contains metallic nanoparticles for release of Ag, Au or CuO ions and the retention arm is covered by an electro-spun mat.
13. The device according to claim 1, wherein the retention arm contains metallic nanoparticles for release of Ag, Au or CuO ions and the retention arm is covered by an electro-spun mat also containing the metallic nanoparticles for additional release of ions for contraceptive purposes and/or for infection prevention of infections.
14. The device according to claim 1, wherein the distal copper tube is crimped onto the stem, the distal copper tube being crimped onto the stem holding all the copper tubes together.
15. The device according to claim 1, further comprising a tail for the removal of the device, the tail comprising a drug-eluting, semi-rigid fiber which is comprised of a combination of metallic nanoparticle-containing material and electro-spun polymeric material, thereby releasing ions from metallic nanoparticles.
16. The device of claim 1, wherein the device has a total copper load between 300 and 600 mg.
17. The device according to claim 1, wherein said retention arm is -shaped.
18. The device according to claim 1, wherein the stem is made of polypropylene.
19. The device according to claim 1, further comprising additional copper cylinders embedded on both sides of the retention arm.
20. The device according to claim 1, further comprising an additional copper, stainless steel, gold, or silver wire or spiral running through an inner side of the loosely threaded copper tubes and affixed in a central hole in said extension of the retention arm.
21. The device according to claim 1, wherein, the device comprises exactly one stem and exactly one arm, the extension centrally provided on the retention arm is located transverse to the retention arm, the one stem is secured to the extension, thereby extending from a middle of the one arm, the one arm being transverse to the one stem.
22. A T- or -shaped intrauterine device comprising: a frameless stem having a diameter of between 0.3 and 1.2 mm; a retention arm connected to said stem; and two copper tube systems provided on said stem, each of said copper tube systems freely movable independently from each other copper tube system, each said copper tube system having copper tubes that are freely movable to allow contact with an endometrial milieu, the copper tube systems being freely rotatable around the stem, the copper tubes freely movable up and down the stem, wherein a distal one of the copper tubes of each system is crimped onto said stem to prevent the copper tubes from sliding off said stem; and a tail for removal of the device.
23. The device according to claim 22, wherein a lower end of said stem is provided with a thickening portion that keeps the copper tubes from sliding off said stem, and the tail is tied to the lower end of said stem, the tail being tied to the thickening portion.
Description
DESCRIPTION OF THE DRAWINGS
(1) These and other characteristics of the invention will be more readily understood when referring to the description as well as the accompanying drawings which represent, merely by way of examples, several embodiments of the invention, and in which:
(2) FIG. 1 is a view of the preferred embodiment of the invention having a straight retention arm, provided with two embedded copper cylinders on both sides of the retention arm, connected to frameless body consisting of a succession of hollow copper elements.
(3) FIG. 2 is another view of the retention arm consisting of three segments, a mid-section and two flexible tips at the ends.
(4) FIG. 3 represents another embodiment of the invention of which the retention arm is -shaped and is connected in a similar way as in FIG. 1.
(5) FIG. 4 is a schematic view of realization to connect the T-shaped retention arm with the frameless body or stem of the IUD. The first copper tube is adapted to a plastic extension in the middle of the retention arm which is the preferred embodiment of the T-shaped IUD according to the invention.
(6) FIG. 5 shows a cross sectional detail of the connection with special reference to the suture which passes through a longitudinal hole in the middle of the extension of the retention arm as well as through the retention arm and connects both the retention arm and the body of the IUD by heat deformation of the tip of the suture so that both parts are secured together.
(7) FIG. 6 is another schematic cross sectional view of realization to connect the T-shaped retention arm with the frameless body or stem of the IUD. The first (proximal) copper tube is fixed on a plastic extension in the middle of the retention arm which is the preferred embodiment of the -shaped IUD according to the invention.
(8) FIG. 7 shows a cross sectional detail of the connection with special reference to the suture which passes through a hole in the middle of the T- or -shaped retention arm and connects both the retention arm and the body of the IUD by heat deformation of the tip of the suture so that both parts are secured together.
(9) FIG. 8 shows the conventional T-shaped TCu380A IUD which has a plastic frame on which copper is added: a copper wire on the stem of the IUD and copper tubes on the retention arm. The horizontal arm is 32 mm long and the vertical stem 36 mm.
(10) FIGS. 9 and 10 show another representation of the invention whereby the copper tubes are threaded on a very thin stem that can be drug eluting. The copper tube are kept in place by crimping the lower copper tube on the stem (FIG. 9) or by a molded part that is large enough to prevent the tube from sliding off the stem (FIG. 10). In one embodiment of the invention, an additional copper or stainless steel, gold, or silver wire or spiral is provided, running through the inner side of the loose copper tubes and is affixed in a central hole in the extension of the retention arm.
(11) FIGS. 11 and 12 show the devices having an additional drug eluting tail for infection prevention. In FIG. 12, the retention arm is covered with an electro-spun mat releasing ions from metallic nanoparticles.
(12) FIGS. 13 an 14 are modes of realization that are similar to the figures in FIGS. 9 and 10 with this difference that the active substance consists of inner and outer copper tubes (FIG. 13) which can freely move independent from each other to increase the effective copper surface area without increasing the total foreign body surface area to limit the impact on menstrual blood loss. The stem in FIG. 14 is covered by a metallic nanoparticle-loaded ion-eluting segment at the inside of the copper tubes. The retention arm can be T- or -shaped (not shown).
(13) FIG. 15 are modes of realization for the retention of the IUD according to the invention whereby, the IUD is suspended by sutures transfixed through the fundus of the uterus and attached using biodegradable material on the surface of the uterus. When the uterus has regained its normal size, the biodegradable material will have been absorbed, leaving only the transverse arm of the IUD to retain it in the involuted uterine cavity.
(14) FIG. 16. Is a similar situation as in FIG. 15. However, the IUD is not suspended with a suture(s) but by biodegradable extensions of the transverse arm that are foldable when the involuting muscle pushed the tube-shape extensions towards the midline before being absorbed completely.
DETAILED DESCRIPTION
(15) Referring now particularly to FIG. 1, a straight horizontal retention arm 11 is made of limited length, preferably no longer that 28 mm, consisting of a semi-flexible material such as polyethylene and which is provided (or not) with two copper tubes 12, 12 embedded on both sides of the retention arm 11 and which is connected in the middle of the retention arm with a frameless body 13 constituting the stem of the IUD which consist of a series of hollow copper tubes 14, threaded on a length of a suture thread 15, of which the top copper tube 16 is connected with a vertical extension (not shown) of the retention arm and which is not longer than the length of the first copper tube, and of which the bottom copper tube 17 is crimped (not shown) on the suture thread. This assembly connects both the horizontal retention arm 11 and frameless stem 13 of the IUD securely together.
(16) Referring to FIG. 2, the segmented retention arm 21 consists of a mid-section 21 with an extension 21 in the middle and two other segments 22 and 22 at both extremities of the arm that form a flexible connection with the mid-section, for example by a localized narrowing of the material such as polyethylene.
(17) Referring now particularly to FIG. 3, a curved, -shaped retention arm 31, consisting of a flexible material such as polyethylene and which connected in the middle of the retention arm with a frameless body 32 constituting the stem of the IUD which consist of a series of hollow copper tubes, threaded on a length of a suture thread 33, of which the top copper tube 34 is connected with a vertical extension of the retention arm and which is not longer than the length of the first copper tube, and of which the bottom copper tube 35 is crimped on the suture thread 36. This assembly connects both the retention arm and frameless body of the IUD securely together.
(18) Referring to FIG. 4 which is a view of the T-shaped IUD which shows the straight horizontal retention arm 41 with extension 42, and of which the extension adapts, for example by friction, with the upper copper tube 43, and of which the extension is not longer than said tube.
(19) FIG. 5 is a schematic cross sectional view of the upper end of a T-shaped retention arm 51 with special reference to the suture 52 which passes through a longitudinal hole in the middle of the extension 53 of the retention arm as well as through the retention arm itself and connects both the retention arm and the frameless body of the IUD 54 by heat deformation of the tip 55 of the suture 52 so that both parts are secured together.
(20) Referring now to FIG. 6 which is another schematic view of the -shaped retention arm 61 with extension 62, and of which the extension adapts, for example by friction, with the upper copper tube 63 and which is not longer than said tube.
(21) FIG. 7 is a cross sectional view of the upper end of the suture 71 which is heat deformed forming a spherical or mushroom-shaped body 71 which is embedded in a small protruding part 72 made in the upper part of the mid-section of the retention arm. The longitudinal hole 73 in extension 74 is illustrated.
(22) FIG. 8 shows the difference between the IUD according to the invention and the standard conventional TCu380A IUD. The retention arm 81 of the TCu380A as well as the stem 82 are significantly longer. Furthermore the stem is semi-rigid whilst with the IUD according to one aspect of the invention the body is completely flexible. In addition, the copper wire of the TCu380A is not hollow and the part of the wire against the plastic frame does not release copper ions. The copper collars 83 and 83 on the retention arm are superimposed and not embedded in the plastic frame. The total effective copper surface area of 254 mm.sup.2 is significantly smaller.
(23) FIG. 9 a further embodiment according to the invention whereby on the thin and flexible plastic stem 91 of the framed IUD copper tubes 92 are assembled which can freely move to allow contact with the endometrial milieu and of which the lower copper tube 93 is crimped (not shown) onto the stem to avoid the copper tubes to slide off the stem and also affixes a tail 94 for removal of the IUD.
(24) FIG. 10 is still a further embodiment according to the invention whereby, on the thin and flexible plastic stem 101 of the framed IUD, copper tubes 102 are assembled which can freely move to allow contact with the endometrial milieu and of which the lower end of the stem is provided with a thickening of the stem 103 to avoid the copper tubes to slide off the stem and to which a tail 104 can be tied for the removal of the IUD.
(25) FIG. 11 shows an additional particularity of the invention in which a second tail of the IUD consists of a metallic nanoparticle containing polymeric drug delivery system 111 covered by a outer layer consisting of a loaded electro-spun fiber mat.
(26) FIG. 12 shows yet an additional particularity of one aspect of the invention in which a transverse arm of the IUD consists of plain plastic or of a metallic nanoparticle containing polymeric drug delivery system 121 covered by a outer layer consisting of a loaded electro-spun fiber mat.
(27) FIG. 13 is still a further embodiment according to the invention whereby the stem consists of a series of inner copper tubes 131 and outer copper tubes 132.
(28) FIG. 14 is still another embodiment according to the invention whereby the stem consists of an inner polymer loaded with metallic or other nanoparticles 141 and a series of outer copper tubes 142.
(29) FIG. 15 shows a mode of realization for the retention of the IUD according to the invention whereby, the IUD 151 is suspended by sutures 152 transfixed through the fundus of the uterus and attached using biodegradable material 153 on the surface of the uterus.
(30) FIG. 16. The IUD 161 in FIG. 16 is not suspended with a suture(s) but by biodegradable extensions 162 of the transverse arm that are foldable as a consequence of pressure of the muscle when the uterus becomes smaller.
(31) The invention discloses, separately or in combination the following various additional features that can be applied to the devices as claimed.
(32) A T or shaped intrauterine device wherein the stem of the framed IUD is between 0.3 and 1.2 mm in diameter on which copper tubes are assembled that can freely move to allow contact with the endometrial milieu and of which the lower copper tube is crimped onto the stem to avoid the copper tubes to slide off the stem and also contains a tail for removal of the IUD.
(33) According to another aspect, a lower end of the stem of the framed IUD is provided with a thickening to avoid the copper tubes to slide off the stem and to which also a tail is tied for removal of the IUD.
(34) According to still another aspect the shape of the tubes can be cylinders, spheres, egg-shaped, prism, square, triangular or any geometric design with a hollow core to allow contact with endometrial fluids and release ions from multiple surfaces.
(35) The stem may consist of a double copper tube system, of which both can freely move independently from each other, in order to increase the copper surface area.
(36) The frameless or framed IUD of which the stem consists of a double tube system of which the inner tube is a polymeric copper or copper oxide, or other noble metal nanoparticle ion release system, surrounded by freely moving copper tubes.
(37) A frameless/framed IUD which is provided with a means whereby the IUD is suspended by suture that fix the IUD through the entire wall of the uterine fundus and which are secured temporarily to a biodegradable body on the surface of the uterus.
(38) The transverse arm is provided with foldable, biodegradable extensions that prevent downward displacement and expulsion of the IUD.
(39) The invention has been described and illustrated merely by way of examples which are in no way restrictive. Numerous changes in its conception may be made without departing from the spirit of the invention.
