Interventional deployment and imaging system

• US 9,357,977 B2
• Filed: 01/05/2007
• Issued: 06/07/2016
• Est. Priority Date: 01/12/2006
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Grossman, Jessica
• Primary Examiner(s): REMALY, MARK DONALD
• Application Number:
  US11/620,594
• Publication Number:
  US 20070179380A1
• Time in Patent Office: 3,441 Days
• Field of Search: 600/407, 600425-427, 600/436, 600/437, 600439-447, 600459-466, 600/470, 600/471, 600/472, 600/476, 600/478
• US Class Current: 1/1
• 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, and a handle structure at the proximal end, wherein the sheath is open at its proximal end and at its distal end;

an imaging core removably coupled to the sheath and adapted to be inserted into the sheath through the open proximal end, removed from the sheath through the open proximal end, and reused, wherein an imaging transducer on the core extends through the open distal end of the sheath when the core is present therein and wherein the imaging transducer may be deflected when the transducer extends beyond the sheath, and wherein the imaging core further comprises a handle structure at a proximal end of the imaging core, the handle structure of the sheath being configured to mate with the handle structure of the imaging core; and

an interventional core disposed in the sheath.

2. A system as in claim 1, wherein the interventional core is non-removably disposed in the sheath.

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

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

5. A system as in claim 4, wherein the ultrasonic transducer comprises a phased array of transducer elements.

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

7. A system as in claim 6, wherein the imaging core comprises at least one pull wire to effect deflection.

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

9. A system as in claim 8, wherein the tissue-penetrating element is adapted to reciprocate through a distal port to extend axially from the sheath.

10. A system as in claim 8, wherein the tissue-penetrating element comprises an electrode adapted to deliver electrical current to tissue.

11. A system as in claim 8, wherein the tissue-penetrating element is a hollow needle adapted to deliver substances to tissue or associated vasculature.

12. A system as in claim 1, wherein when the handle structures of the imaging core and the sheath are mated, the imaging core and the interventional core are in a predetermined geometric relationship with one another.

13. A system as in claim 1, wherein the handle structure of the sheath comprises a cradle adapted to receive the handle structure of the core when the imaging core and the sheath are mated.

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

a sheath having a proximal end, a distal end, and a handle structure at the proximal end, wherein the sheath is open at its proximal end and at its distal end and the sheath is adapted to be transvaginally introduced to locate the distal end in a uterus;

an ultrasonic imaging core removably coupled to the sheath and having a field of view, said imaging core adapted to be inserted into the sheath through the open proximal end, removed from the sheath through the open proximal end, and sterilized for reuse, wherein an imaging transducer on the core extends through the open distal end of the sheath when the core is present therein and wherein the imaging transducer may be deflected when the transducer extends beyond the sheath, and wherein the imaging core further comprises a handle structure at a proximal end of the imaging core, the handle structure of the sheath being configured to mate with the handle structure of the imaging core; and

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

15. A system as in claim 14, wherein the needle reciprocates axially.

16. A system as in claim 14, wherein the ultrasonic imaging core is adapted to image laterally.

17. A system as in claim 16, wherein the needle reciprocates laterally.

18. A system as in claim 14, wherein the needle comprises an electrode adapted to deliver electrical current to tissue.

19. A system as in claim 14, wherein the needle is a hollow needle adapted to deliver substances to tissue or associated vasculature.

20. A system as in claim 14, wherein the ultrasonic imaging core comprises a phased array transducer.

21. A system as in claim 14, wherein the ultrasonic imaging core is flexible over at least its distal end.

22. A system as in claim 14, wherein the ultrasonic imaging core has a distal end which is selectively deflectable.

23. A system as in claim 22, wherein the ultrasonic imaging core comprises at least one pull wire to effect deflection.

24. A system as in claim 14, wherein when the handle structures of the imaging core and the sheath are mated, the imaging core and the needle are in a predetermined geometric relationship with one another.

25. A system as in claim 14, wherein the handle structure of the sheath comprises a cradle adapted to receive the handle structure of the core when the imaging core and the sheath are mated.