Intra uterine device

• US 9,750,634 B2
• Filed: 01/14/2010
• Issued: 09/05/2017
• Est. Priority Date: 01/18/2009
• Status: Active Grant

• Current Assignee: OCON Medical Ltd
• Original Assignee: OCON Medical Ltd
• Inventors: Bar-Am, Ilan
• Primary Examiner(s): Rodriquez, Kari
• Application Number:
  US13/144,624
• Publication Number:
  US 20110271963A1
• Time in Patent Office: 2,791 Days
• Field of Search: 128830-833, 128839-840, 606191, 606193-194, 606285, 606530
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 6/142 Wirelike structures, e.g. loops, rings, spirals
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube

Abstract

The present invention discloses an Intra Uterine Ball (IUB) device useful for a gynecological procedure or treatment. The aforesaid device comprises a hollow sleeve for at least partial insertion into the uterine cavity; and, an elongate conformable member with at least a portion comprised of shape memory alloy. The elongate member is adapted to be pushed out from said sleeve within said uterine cavity. It is the core of the invention that the elongate member is adapted to conform into a predetermined three dimensional ball-like configuration within said uterine cavity following its emergence from said sleeve, such that expulsion from said uterine cavity, malposition in said uterine cavity, and perforation of the uterine walls is prevented.

Claims

1. An intra uterine device comprising an elongate conformable member with at least a portion including a contraceptive agent having shape memory adapted to conform into a predetermined three dimensional configuration formed by at least two loop-like structures approximately perpendicular with respect to each other when released from a hollow sleeve positioned within a uterine cavity, wherein a first plane defined within a first loop-like structure crosses through a second and approximately perpendicular plane defined within a second loop-like structure, and wherein said three dimensional configuration is capable of elastically contracting and expanding in response to contraction and expansion of said uterine cavity thereby enabling said three dimensional configuration to maintain its position within said uterine cavity, wherein the elongate conformable member has a proximal end and a caudal end and is configured to be linearized in the hollow sleeve into a single straight elongate conformable member having the proximal end at one end of the sleeve and the caudal end at the other end of the sleeve and is configured to be introduced from the sleeve into the uterine cavity to assume the predetermined three dimensional configuration.

2. The intra uterine device of claim 1, wherein said at least said portion having said shape memory is configured to fold into only two loop-like structures.

3. The intra uterine device of claim 2, wherein said elongate conformable member is composed of Nitinol.

4. The intra uterine device of claim 1, wherein said three dimensional configuration has a diameter of about 10 mm to about 15 mm.

5. The intra uterine device of claim 1, wherein said contraceptive agent is copper or a contraceptive hormone.

6. The intra uterine device of claim 1, wherein said three dimensional configuration facilitates release of said contraceptive agent into said intrauterine cavity in a uniform manner.

7. The intra uterine device of claim 1, wherein the device consists essentially of the elongate conformable member and wherein the three-dimensional configuration is ball-like in shape.

8. A method of contraception comprising:

(a) providing an elongate conformable member including at least a portion having a shape memory adapted to conform into a predetermined three dimensional configuration formed by at least two loop-like structures approximately perpendicular with respect to each other, wherein a first plane defined within a first loop-like structure crosses through a second and approximately perpendicular plane defined within a second loop-like structure, said elongate member including a contraceptive agent, wherein the elongate conformable member has a proximal end and a caudal end; and

(b) delivering said elongate member through a hollow sleeve into a uterine cavity to thereby form said three dimensional configuration in said uterine cavity wherein the elongate conformable member is linearized into a single straight elongate conformable member in the hollow sleeve with the proximal end at one end of the sleeve and the caudal end at the other end of the sleeve and introduced proximal-end first from the sleeve into the uterine cavity to assume the predetermined three dimensional configuration;

wherein said three dimensional configuration is capable of elastically contracting and expanding in response to contraction and expansion of said uterine cavity thereby enabling said three dimensional configuration to maintain its position within said uterine cavity and release said contraceptive agent therein.

9. The method according to claim 8, wherein one loop-like structure is positioned opposite a uterine fundus following emergence of said elongate member from said hollow sleeve.

10. The method of claim 8, wherein said three dimensional configuration has a diameter of about 10 mm to about 15 mm.