Fully integrated, disposable tissue visualization device

• US 10,092,176 B2
• Filed: 09/07/2016
• Issued: 10/09/2018
• Est. Priority Date: 01/13/2014
• Status: Active Grant

• Current Assignee: Trice Medical, Inc.
• Original Assignee: Trice Medical, Inc.
• Inventors: Kienzle, Richard A., Washburn, II, Richard H., Briganti, Richard T., Deirmengian, Carl
• Primary Examiner(s): NEAL, TIMOTHY JAY
• Application Number:
  US15/258,968
• Publication Number:
  US 20170086666A1
• Time in Patent Office: 762 Days
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/0002 provided with data storages
• CPC Class Codes: A61B 1/00045 Display arrangement
• CPC Class Codes: A61B 1/00066 Proximal part of endoscope body, e.g. handles A61B1/0052 takes precedence
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00098 Deflecting means for inserted tools
• CPC Class Codes: A61B 1/00103 designed for single use
• CPC Class Codes: A61B 1/00108 characterised by self-sufficient functionality for stand-alone use
• CPC Class Codes: A61B 1/0011 Manufacturing of endoscope parts
• CPC Class Codes: A61B 1/00114 Electrical cables in or with an endoscope
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/00163 Optical arrangements A61B1/002, A61B1/06 take precedence
• CPC Class Codes: A61B 1/002 having rod-lens arrangements A61B1/055 takes precedence
• CPC Class Codes: A61B 1/012 characterised by internal passages or accessories therefor
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/045 Control thereof
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 1/317 : for bones or joints, e.g. osteoscopes, arthroscopes
• CPC Class Codes: A61B 17/34 : Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3415 : for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3468 : for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/0023 : disposable
• CPC Class Codes: A61B 2017/3456 : blunt

Abstract

The present invention relates to a fully integrated sterilizable one time use disposable tissue visualization device and methods for using such devices. Preferred embodiments of the invention facilitate the visualization of an internal tissue site while causing a minimum of damage to the surrounding tissue. Further preferred embodiments may allow for the delivery of fluids and other treatment to an internal tissue site.

Claims

1. A minimally invasive method of accessing and visualizing an internal target site of a patient, comprising the steps of:

percutaneously accessing target tissue with a tubular needle having a sharpened distal tip and a visualization element therein, the accessing step accomplished with the sharpened distal tip positioned distally of the visualization element;

blunting the sharpened distal tip;

visualizing the target tissue; and

wherein a distal end of the visualization element is biased against an inner diameter of the tubular needle.

2. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, wherein blunting the sharpened tip comprises retracting the sharpened distal tip proximally of a distal end of the visualization element following the accessing step.

3. A minimally invasive method of accessing and visualizing an internal target site as in claim 2, wherein the visualization element is biased to press the distal end of the visualization element laterally against the inner diameter of the sharpened distal tip of the tubular needle to protect tissue from damage.

4. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, wherein the accessing target tissue step comprises accessing an orthopedic joint capsule.

5. A minimally invasive method of accessing and visualizing an internal target site as in claim 4, wherein the blunting step is accomplished following entry of the sharpened distal tip into the joint capsule.

6. A minimally invasive method of accessing and visualizing an internal target site as in claim 4, additionally comprising the step of injecting therapeutic media into the orthopedic joint capsule.

7. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, wherein the accessing target tissue step comprises accessing tissue within a vertebral disc.

8. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, wherein the accessing target tissue step comprises accessing tissue within a pericardium.

9. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, additionally comprising the step of flushing the target tissue.

10. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, additionally comprising the step of capturing images of the target tissue.

11. A minimally invasive method of accessing and visualizing an internal target site as in claim 10, wherein the images are captured along a primary viewing axis residing at an angle of at least about 5 degrees from a longitudinal axis of the tubular needle.

12. A minimally invasive method of accessing and visualizing an internal target site as in claim 11, wherein the images are captured along a primary viewing axis residing at an angle of at least about 10 degrees from the longitudinal axis of the tubular needle.

13. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, additionally comprising the step of injecting therapeutic media.

14. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, additionally comprising the step of aspirating fluid from the location of the target tissue.

15. A minimally invasive method of accessing and visualizing an internal target site as in claim 1, additionally comprising the step of displaying real time images on a video screen.

16. A method of visualizing an internal tissue site, comprising:

providing a visualization needle, the visualization needle comprising;

an elongate tubular needle, extending along a longitudinal axis between a proximal end comprising a handpiece and a distal end comprising a sharpened tip,

an elongate optical element extending through the needle,

wherein the elongate optical element is biased against an inner diameter of the elongate tubular needle; and

guiding the visualization needle through tissue to reach an internal tissue site.

17. The method of claim 16, wherein a distal end of the elongate optical element is biased to press the distal end of the elongate optical element against the distal end of the elongate tubular needle to providing blunting of the elongate tubular needle.

18. The method of claim 17, wherein an outer diameter of a distal end of the elongate optical element is biased against an inner diameter of the point of the sharpened tip of the needle.

19. The method of claim 16, wherein the handpiece comprises a control, the control configured to axially move the needle between a proximal position in which the sharpened tip is proximal to a distal end of the optical element, and a distal position where the sharpened tip is distal to the distal end of the optical element.

20. The method of claim 19, wherein axial proximal movement of the probe deflects the distal end of the optical element laterally by at least about 3 degrees.

21. The method of claim 16, wherein the blunting is configured to prevent damage to an internal tissue site.

22. The method of claim 16, wherein the optical element has an outside diameter that is smaller than an inside diameter of the tubular needle to define a lumen extending the length of the tubular needle, the lumen configured to provide aspiration or irrigation to the distal end of the elongate tubular needle.

23. The method of claim 22, wherein the lumen is in communication with an injection or aspiration port located in the handpiece.

24. The method of claim 16, wherein the handpiece is configured to wirelessly communicate with an external viewing device.

25. The method of claim 16, wherein the sharpened tip comprises a reverse grind, the reverse grind providing blunting at an outer diameter of the needle and sharpening at an inner diameter of the needle.

26. The method of claim 16, wherein the handpiece further comprises a memory chip comprising an algorithm configured to correct an image artifact.

27. The method of claim 26, wherein the algorithm is uniquely generated for an individual visualization needle.

28. The method of claim 16, wherein the handpiece further comprises a memory chip configured to store data on the characteristics of the visualization needle.

29. The method of claim 28, wherein the characteristics are selected from the group consisting of LED illumination performance data, correction algorithms for correction of a lens, and correction information for chromatic aberrations of an image sensor.

30. The method of claim 16, wherein a distal end of the optical element is configured to provide illumination.

31. The method of claim 30, wherein illumination is provided by a plurality of LEDs located at the distal end of the optical element.

32. The method of claim 31, wherein illumination is provided by a plurality of LEDs located in the handpiece.

33. The method of claim 31, wherein an LED is configured to provide light in a wavelength outside the visible spectrum.

34. The method of claim 31, wherein the LED is configured to provide light in the UV spectrum.

35. The method of claim 30, wherein illumination is provided by a plurality of LEDs positioned in the optical element adjacent to an image sensor, the illumination transmitted to the distal end of the optical element by fiber optics.

36. The method of claim 30, wherein the distal end of the optical element comprises a diffusion element, the diffusion element configured to provide uniform illumination.

37. The method of claim 16, wherein the visualization needle further comprises an integrated articulation mechanism, the integrated articulation mechanism configured to provide movement to a distal end of the optical element.