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1. WO2020117687 - PASSING TENSION MEMBER AROUND TISSUE MASS

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[ EN ]

WHAT IS CLAIMED IS:

1. An apparatus for passing a tension member around a volumetric region of an organ, the apparatus comprising:

a rigid outer tube comprising a sharp outer tube tip and an outer tube lumen with an outer tube opening in proximity to the outer tube tip;

an inner needle comprising an elastic needle body curved at least in part thereof, the inner needle ending with a sharp needle tip and enclosing an inner needle lumen with an inner needle opening being in proximity to the needle tip, the inner needle body being configured to pass straightened through the outer tube lumen and to partially protrude via the outer tube opening, such that a protruding portion of the inner needle body is allowed to voluntarily flex to a curved form having diameter equal to or greater than diameter of the volumetric region; and

a tension member passer comprising a tension member passer body, sized for passing through the inner needle lumen, and a tension member pulling portion configured for engaging with a portion of the tension member and for continuously applying a pulling force to the engaged portion of the tension member when the tension member is withdrawn with the tension member passer;

wherein the apparatus is configured for forming a passage through the organ, the passage extending along a plane crossing the volumetric region from an entry point at a surface of the organ, located in front of a first side of the volumetric region, to an exit point at the surface of the organ, located in front of a second side of the volumetric portion opposite to the first side, and the apparatus is further configured for passing the tension member around the volumetric region by pulling the tension member from the exit point to the entry point through the passage.

2. An apparatus according to claim 1, wherein the volumetric region of the organ includes a tissue mass comprising at least a portion of a tumor.

3. An apparatus according to claim 1, wherein the outer tube is movable relative to a covering portion of the apparatus until the outer tube tip extends a chosen uncovered length from a distal edge of the covering portion, the distal edge is configured to resist penetration into soft tissue to inhibit insertion of the outer tube to a depth greater than the uncovered length.

4. An apparatus according to claim 1, the needle body includes a first segment having a first centerline, and a second segment having a second centerline, the second segment adjoins with a proximal end thereof to a distal end of the first segment and with a distal end thereof to a proximal end of a tip segment, wherein, when the needle body is in an unstressed relaxed form, the first centerline has a first radius of curvature, at least along a portion thereof being adjacent to the first segment distal end, and the second centerline has a second radius of curvature, at least along a portion thereof being adjacent to the second segment proximal end, the second radius of curvature is smaller than the first radius of curvature.

5. An apparatus according to claim 4, wherein a ratio between the second radius of curvature and the first radius of curvature is within a range of 1/10 to 1/3.

6. An apparatus according to claim 4, wherein, when the needle body is in the unstressed relaxed form, the first segment subtends a first subtended angle and/or the second segment subtends a second subtended angle, wherein the second subtended angle is smaller than the first subtended angle.

7. An apparatus according to claim 6, wherein the first subtended angle is within a range of 200° to 300°, and/or the second subtended angle is within a range of 10° to 80°.

8. An apparatus according to claim 4, wherein the first radius of curvature is within a range of 15 mm to 45 mm when the needle body is in the unstressed relaxed state.

9. An apparatus according to claim 1, wherein the elastic needle body is configured with elastic resistance to straightening within a range of 2 N to 20 N.

10. An apparatus according to claim 1, configured such that the protruding portion exits the outer tube opening with a needle exit angle d within a range of 10° to 80°, relative to the outer tube.

11. An apparatus according to claim 1, wherein the tension member passer body is flexible and elastic.

12. An apparatus according to claim 1 , wherein the tension member pulling portion includes a securing member forming a loop with the tension member passer body.

13. An apparatus according to claim 1, wherein the tension member passer body has a curved or bent portion forming a deviated distal end portion inclined relative to remainder of the tension member passer body.

14. An apparatus according to claim 13, wherein the deviated tension member passer distal end portion forms with rest of the tension member passer body a deviation angle within a range of 15° to 55°.

15. An apparatus according to claim 13, wherein the tension member pulling portion includes a securing wire portion extending from a first location on the tension member passer body, distally to the curved or bent portion, to a second location on the tension member passer body, proximally to the curved or bent portion.

16. An apparatus according to claim 15, wherein the securing wire portion is similar in length to length of a segment of the tension member passer body extending from the first location to the second location.

17. An apparatus according to claim 15, wherein the securing wire portion is configured to undergo increased tension when the deviated tension member passer distal end portion is forced to align with rest of the tension member passer body.

18. An apparatus according to claim 15, wherein the deviated tension member passer distal end originates at the first location and extends in a straight form at least 10 mm in length.

19. An apparatus according to claim 13, wherein the curved or bent portion of the tension member passer body is configured with elastic resistance to straightening within a range of 0.1 N to 1 N.

20. An apparatus according to claim 1, further comprising a console, optionally formed as a handheld device.

21. An apparatus according to claim 1, further comprising an inner needle protrusion controller configured to operatively control advancement of the inner needle within the outer tube.

22. An apparatus according to claim 1, further comprising a tension member passer protrusion controller configured to operatively control advancement of the tension member passer body within the inner needle.

23. An apparatus according to claim 20, further comprising a forceps head fixedly positioned distally to the console and activatable via the console, configured for selective grasping of the organ adjacent to the entry point and/or the exit point, for holding the grasped organ at a fixed distance relative to the console.

24. An apparatus according to claim 23, wherein the forceps head is configured in a form of tenaculum having two hinged tenaculum arms, each tenaculum arm includes a slender sharp-pointed hook configured to penetrate through the organ surface into the organ when the forceps head is operated to grasp the organ surface.

25. An apparatus according to claim 23, wherein the outer tube is slidable distally relative to the forceps head such that the outer tube tip is extendable distally beyond the forceps head, wherein the apparatus is configured to prevent extension of the outer tube tip distally beyond the forceps head over a predetermined maximal penetration depth.

26. A method for passing a tension member around a volumetric region of an organ, the method comprising:

using a rigid outer tube, comprising a sharp outer tube tip and an outer tube lumen with an outer tube opening in proximity to the outer tube tip, penetrating into the organ such that the outer tube tip reaches a penetration depth;

passing an inner needle in the outer tube lumen, the inner needle includes an elastic needle body curved at least in part thereof, ending with a sharp needle tip and enclosing an inner needle lumen with an inner needle opening in proximity to the needle tip;

piercing a curved passage with the needle tip around the volumetric region with a protrusion length of a protruding portion of the inner needle body, by pushing the inner needle via the outer tube opening and allowing the protruding portion to voluntarily flex to a curved form having diameter equal to or greater than diameter of the volumetric region;

advancing a tension member passer comprising a tension member passer body and a tension member pulling portion, in the inner needle lumen and via the inner needle opening, until the tension member pulling portion exits the organ at an exit point opposing the entry point relative to the volumetric region; and

drawing the tension member into and through the curved passage by pulling the tension member passer with the secured tension member.

27. A method according to claim 26, wherein the drawing includes extending the tension member around the volumetric region such that one end of the tension member projects from the entry point and another end of the tension member projects from the exit point.

28. A method according to claim 26, wherein the organ is an internal organ located within a body of a live subject, and the method further comprising forming a surgical route from outside the body of the subject and delivering the outer tube through the surgical route until the outer tube tip reaches the organ.

29. A method according to claim 28, wherein the organ is a uterus.

30. A method according to claim 26, wherein the volumetric region of the organ includes a tissue mass comprising at least a portion of a tumor.

31. A method according to claim 26, comprising ending the piercing with positioning the needle tip at a chosen distance from the surface of the organ, so as to form a needle tip angle between the needle tip and the surface of the internal body region.

32. A method according to claim 31, wherein the distance is smaller than 3 cm, and/or the needle tip angle is within a range of 10° to 60°.

33. A method according to claim 26, wherein the defining includes defining a penetration angle between the outer tube and a perpendicular line to the surface of the internal body region at the entry point, wherein the protrusion length subtends a subtended angle is at least 270° minus the penetration angle.

34. A method according to claim 26, wherein the penetrating, the passing, the piercing, the advancing and/or the securing is repeated, each repetition is performed using a different implanted tension member, a different entry point and a different exit point.

35. A method according to claim 26, comprising:

using a forceps head, grasping the organ adjacent to the entry point and/or the exit point for holding the grasped organ before the penetrating with the outer tube.

36. A method according to claim 35, the outer tube is slidably connected to a console and the forceps head is fixedly positioned distally to the console, wherein the outer tube is slidable distally relative to the forceps head such that the outer tube tip is extendable distally beyond the forceps head up to a predetermined maximal penetration depth.