INTERVENTIONAL DEPLOYMENT AND IMAGING SYSTEM

• US 20070179380A1
• Filed: 01/05/2007
• Published: 08/02/2007
• Est. Priority Date: 01/12/2006
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Grossman, Jessica
• Granted Patent: US 9,357,977 B2
• Time in Patent Office: Days
• US Class Current: 600/462
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0073 by tomography, i.e. reconstruction of 3D images from 2D projections A61B5/0066 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/14 Echo-tomography
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

Needle deployment and imaging system includes a sheath, an imaging core, and interventional core. The imaging core and interventional core are received in first and second axial passages in the sheath and at least one of said cores will be removable and replaceable within the sheath. The imaging core may be extended from the sheath or be sealed within the first axial passage of the sheath. The interventional core will typically be advanced laterally or axially from a location near the distal end of the sheath.

Claims

1. A needle deployment and imaging system comprising:

a sheath having a proximal end, a distal end, a first axial passage, and a second axial passage isolated from the first axial passage;

an imaging core disposed in the first axial passage; and

an interventional core disposed in the second axial passage;

wherein at least one of the imaging core and the interventional core is removable and replaceable in its respective axial passage.

2. A system as in claim 1, wherein the imaging core is removable and replaceable and the treatment core is non-removably disposed in the second axial passage.

3. A system as in claim 1, wherein the interventional core is removable and replaceable and the imaging core is non-removably affixed in the first axial passage.

4. A system as in claim 1, wherein the first axial passage is sealed to the exterior and a transparent window is formed in the sheath to permit imaging by the imaging core.

5. A system as in claim 1, wherein an open window is formed in the sheath to permit imaging by the imaging core.

6. A system as in claim 1, wherein the imaging core extends distally beyond the distal end of the sheath to permit imaging by the imaging core.

7. A system as in claim 1, wherein the imaging core is adapted to image in a distally forward direction.

8. A system as in claim 1, wherein the imaging core is adapted to image in a lateral direction.

9. A system as in claim 1, wherein the sheath has a fixed curved distal end.

10. A system as in claim 9, wherein the distal end is curved to access a target location on a wall of a uterus when introduced through a cervix.

11. A system as in claim 10, further comprising at least a second sheath having a fixed curved distal end to access a second target location on the wall of the uterus.

12. A system as in claim 1, wherein the sheath has a distal end which is selectively deflectable.

13. A system as in claim 12, wherein the sheath comprises at least one pull wire to effect deflection.

14. A system as in claim 1, wherein the imaging core comprises an ultrasonic transducer adapted for imaging.

15. A system as in claim 14, wherein the ultrasonic transducer comprises a phased array of transducer elements.

16. A system as in claim 1, wherein the imaging core is flexible over at least its distal end.

17. A system as in claim 1, wherein the imaging core has a fixed curved distal end.

18. A system as in claim 1, wherein the imaging core has a distal end which is selectively deflectable.

19. A system as in claim 18, wherein the imaging core comprises at least one pull wire to effect deflection.

20. A system as in claim 1, wherein the interventional core comprises a tissue-penetrating element which is axially reciprocatable relative to the sheath.

21. A system as in claim 20, wherein the tissue-penetrating element is adapted to reciprocate through a side port to extend laterally from the sheath.

22. A system as in claim 20, wherein the tissue-penetrating element is adapted to reciprocate through a distal port to extend axially from the sheath.

23. A system as in claim 20, wherein the tissue-penetrating element comprises an electrode adapted to deliver electrical current to tissue.

24. A system as in claim 20, wherein the tissue-penetrating element is a hollow needle adapted to deliver substances to tissue or associated vasculature.

25. A system for treating uterine fibroids, said system comprising:

a sheath having a proximal end, a distal end, a first axial passage, and a second axial passage isolated from the first axial passage, wherein the sheath is adapted to be transvaginally introduced to locate the distal end in a uterus;

an ultrasonic imaging core removable and replaceable in the first axial passage and having a field of view through the distal end of the sheath when in position; and

a needle reciprocatably positioned in the second axial passage and having a distal end which is positionable in the field of view of the ultrasonic imaging core.

26. A system as in claim 25, wherein the first axial passage is sealed to the exterior and an acoustically transparent window is formed in the sheath to permit imaging.

27. A system as in claim 26, wherein ultrasonic imaging core is adapted to image in a distally forward direction and the acoustically transparent window is at the distal end of the sheath.

28. A system as in claim 27, wherein the needle reciprocates axially.

29. A system as in claim 26, wherein the ultrasonic imaging core is adapted to image laterally and the acoustic window is one a side of the sheath.

30. A system as in claim 29, wherein the needle reciprocates laterally.

31. A system as in claim 25, wherein the needle comprises an electrode adapted to deliver electrical current to tissue.

32. A system as in claim 25, wherein the needle is a hollow needle adapted to deliver substances to tissue or associated vasculature.

33. A system as in claim 25, wherein the sheath has a fixed curved distal end.

34. A system as in claim 33, wherein the distal end is curved to access a target location on a wall of a uterus when introduced through a cervix.

35. A system as in claim 34, further comprising at least a second sheath having a fixed curved distal end to access a second target location on the wall of the uterus.

36. A system as in claim 25, wherein the sheath has a distal end which is selectively deflectable.

37. A system as in claim 36, wherein the sheath comprises at least one pull wire to effect deflection.

38. A system as in claim 25, wherein the ultrasonic imaging core comprises a phased array transducer.

39. A system as in claim 25, wherein the ultrasonic imaging core is flexible over at least its distal end.

40. A system as in claim 25, wherein the ultrasonic imaging core has a fixed curved distal end.

41. A system as in claim 25, wherein the ultrasonic imaging core has a distal end which is selectively deflectable.

42. A system as in claim 41, wherein the ultrasonic imaging core comprises at least one pull wire to effect deflection.

43. A method for preparing a needle deployment and imaging system, said method comprising:

(a) providing a previously used system comprising;

a sheath having a proximal end, a distal end, a first axial passage, and a second axial passage isolated from the first axial passage;

an imaging core disposed in the first axial passage; and

a treatment core disposed in the second axial passage.

(b) removing at least one of the imaging core and the treatment core from the sheath;

(c) sterilizing the removed imaging or treatment core; and

(d) replacing the sterilized core into an unused, sterile sheath.