Rigid delivery systems having inclined ultrasound and needle

• US 7,815,571 B2
• Filed: 04/20/2006
• Issued: 10/19/2010
• Est. Priority Date: 04/20/2006
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Deckman, Robert K, Gerbi, Craig, Grossman, Jessica, Munrow, Michael
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US11/409,496
• Publication Number:
  US 20070249939A1
• Time in Patent Office: 1,643 Days
• Field of Search: None
• US Class Current: 600/439
• 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 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 8/445 Details of catheter construction

Abstract

A delivery system includes a rigid shaft, an imaging core, and an interventional core. The rigid delivery shaft has a proximal end, an angled distal tip, and an axial passage therethrough. The imaging core comprises an ultrasound imaging insert disposed within the axial passage. The imaging insert has an ultrasound array within a distal portion thereof, wherein the ultrasound array is tilted relative to a shaft axis. The interventional core comprises a curved ablation needle coupled to the rigid shaft. An angle of needle curvature may be inversely proportional to the ultrasound array tilt and tip angle.

Claims

1. A rigid delivery system comprising:

a rigid shaft having a proximal end, a distal end, a longitudinal axis, and a passage therethrough, wherein the passage has a closed distal end with ultrasonically transparent or translucent side viewing window having a flat inner surface being asymmetrically inclined relative to the longitudinal axis therein;

an ultrasound imaging insert removably disposed within the passage and having an ultrasound array having a flat surface on a side thereof which flat surface aligns with the side viewing window when the insert is placed in the passage such that the flat surface of the ultrasound array contacts the flat inner surface of the shaft after the insert is fully received in the shaft, wherein the ultrasound array has a field of view with a center line which is tilted in a distally forward direction relative to the longitudinal axis and wherein the imaging insert may be removed and reused.

2. The system of claim 1, wherein the ultrasound array is tilted distally forwardly within the insert at an angle in a range from about 7 degrees to about 10 degrees relative to a longitudinal axis of the insert.

3. The system of claim 1, wherein the ultrasound imaging insert further comprises a flat viewing window disposed over the ultrasound array.

4. The system of claim 3, wherein the distal end of the rigid shaft further comprises a mechanical alignment feature for axial or rotational orientation of the ultrasound imaging insert with the closed-end passageway.

5. The system of claim 4, wherein the side viewing window of the rigid shaft comprises a flat viewing surface which aligns with the flat viewing window of the insert to align the insert when placed into the shaft.

6. The system of claim 1, wherein the rigid shaft has a deflectable or pre-shaped distal end.

7. The system of claim 6, wherein the shaft distal end is bent relative to the longitudinal axis of the shaft so that the center line is disposed at an angle in a range from about 10 degrees to about 25 degrees relative to the shaft axis.

8. The system of claim 7, wherein the angle is in a range from about 10 degrees to about 13 degrees.

9. The system of claim 7, wherein the ultrasound imaging insert is flexible.

10. The system of claim 9, wherein the distal portion of the ultrasound imaging insert is bent at the same angle as the shaft deflectable distal end.

11. The system of claim 6, further comprising a curved needle coupled to the rigid shaft.

12. The system of claim 11, wherein an angle of needle curvature is in a range from about 0 degrees to about 90 degrees relative to an axis.

13. The system of claim 12, wherein the angle is about 70 degrees.

14. The system of claim 11, wherein the curved needle comprises an elongate hollow body and a solid distal tip.

15. The system of claim 14, further comprising at least one infusion hole on the elongate hollow body.

16. The system of claim 14, wherein the solid distal tip comprises an asymmetric or offset trocar tip.

17. The system of claim 16, wherein the solid distal tip comprises a plurality of beveled edges offset at a variety of angles.

18. The system of claim 11, further comprising a needle guide attachable to an outer surface of the shaft and having a guide passage isolated from the axial passage, wherein the curved needle is disposed within the guide passage.

19. The system of claim 18, wherein the curved needle and needle guide have a flattened oval shape.

20. The system of claim 11, wherein the curved needle comprises a hollow core needle.

21. The system of claim 20, wherein the hollow core needle is adapted for performing biopsy.

22. The system of claim 20, wherein the hollow core needle is for performing a diagnostic procedure.

23. The system of claim 20, wherein the hollow core needle is adapted for performing sampling.

24. The system of claim 1, further comprising an acoustic coupling between the rigid shaft and ultrasound imaging insert.

25. The system of claim 24, wherein the acoustic coupling comprises a compliant material, fluid, gel, or close mechanical contact between the rigid shaft and ultrasound imaging insert.

26. A method for using an imaging and needle deployment system, said method comprising:

providing a rigid shaft having a proximal end, a distal end, a longitudinal axis, and an axial passage therethrough, wherein the passage has a closed distal end with an untrasonically transparent or translucent side window having a flat inner surface being asymmetrically inclined relative to the longitudinal axis therein, wherein the distal end of the rigid shaft is deflected relative to the longitudinal axis; and

loading an ultrasound imaging insert having an ultrasound array on a side thereof within the closed-end axial passage, wherein the ultrasound array has a flat viewing surface which aligns with the flat inner surface of the side viewing window on the rigid shaft such that the flat surface of the ultrasound array contacts the flat inner surface of the shaft after the insert is fully received in the shaft, and a distal portion of the insert conforms to the deflected shaft distal end so that a center line of a field of view of said ultrasound array is tilted in a distally forward direction relative to the longitudinal axis;

introducing the rigid shaft into a body cavity;

advancing a curved needle from the rigid shaft so that said needle passes across the tilted field of view and enters tissue while the needle is imaged with said imaging array;

removing the rigid shaft from the body lumen; and

removing the ultrasound imaging insert from the shaft to allow re-use of the insert.

27. The method of claim 26, wherein the ultrasound array is tilted distally forward relative to a longitudinal axis of the insert.

28. The method of claim 27, wherein the ultrasound array is tilted at an angle in a range from about 7 degrees to about 10 degrees relative to the longitudinal axis of the insert.

29. The method of claim 26, wherein the needle has a curvature selected so that said needle passes across the field of view.

30. The method of claim 26, wherein the shaft is deflected by pulling a pull wire coupled to the shaft distal end in a proximal direction.

31. The method of claim 26, wherein the distal end is deflected at an angle in a range from about 10 degrees to about 25 degrees relative to the longitudinal axis of the shaft.