Fully integrated, disposable tissue visualization device

• US 9,610,007 B2
• Filed: 06/20/2016
• Issued: 04/04/2017
• Est. Priority Date: 01/13/2014
• Status: Active Grant

• Current Assignee: Trice Medical, Inc.
• Original Assignee: Trice Medical, Inc.
• Inventors: Washburn, II, Richard H., Kienzle, Richard A., Briganti, Richard T., Deirmengian, Carl
• Primary Examiner(s): NEAL, TIMOTHY JAY
• Application Number:
  US15/187,583
• Publication Number:
  US 20160296108A1
• Time in Patent Office: 288 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 sterilized, integrated, one time use disposable visualization needle, comprising:

an elongate tubular needle, extending along a longitudinal axis between a proximal end affixed to a handpiece and a distal end having a sharpened tip;

an elongate optical element extending through the needle;

wherein an outer diameter of the distal end of the elongate optical element is configured to have a bias against an inner diameter of a point of the sharpened tip of the needle, the bias configured to press the distal end of the elongate optical element against the distal end of the elongate tubular needle to provide blunting of the tubular needle.

2. The visualization needle of claim 1, further comprising an image sensor, the image sensor configured to be in optical communication with the elongate optical element.

3. The visualization needle of claim 2, wherein illumination is provided by a plurality of LEDs positioned in the optical element adjacent to the image sensor.

4. The visualization needle of claim 1, 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.

5. The visualization needle of claim 1, wherein the handpiece comprises a control for axially moving the elongate tubular needle between a proximal position in which the sharpened tip is proximal to a distal end of the optical element, and a distal position in which the sharpened tip is distal to the distal end of the optical element.

6. The visualization needle of claim 1, wherein the blunting is configured to prevent damage to a tissue site.

7. The visualization needle of claim 1, wherein axial proximal movement of the elongate tubular needle deflects a distal end of the optical element laterally by at least about 3 degrees.

8. The visualization needle of claim 1, 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 elongate tubular needle, the lumen configured to provide aspiration or irrigation to the distal end of the elongate tubular needle.

9. The visualization needle of claim 8, wherein the lumen is in communication with an injection or aspiration port located in the handpiece.

10. The visualization needle of claim 1, wherein the handpiece is configured to wirelessly communicate with an external viewing device.

11. The visualization needle of claim 1, wherein the handpiece further comprises a memory chip comprising an algorithm configured to correct an image artifact.

12. The visualization needle of claim 11, wherein the algorithm is uniquely generated for an individual visualization needle.

13. The visualization needle of claim 1, wherein the handpiece further comprises a memory chip configured to store data on the characteristics of the visualization needle.

14. The visualization needle of claim 13, 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.

15. The visualization needle of claim 1, wherein the distal end of the optical element is configured to provide illumination.

16. The visualization needle of claim 15, wherein illumination is provided by a plurality of LEDs located at the distal end of the optical element.

17. The visualization needle of claim 16, wherein the LEDs are configured to provide light in a wavelength outside the visible spectrum.

18. The visualization needle of claim 17, wherein the LEDs are configured to provide light in the UV spectrum.

19. The visualization needle of claim 15, wherein illumination is provided by a plurality of LEDs located in the handpiece.

20. The visualization needle of claim 15, wherein illumination is provided by an infrared light source.

21. The visualization needle of claim 1, wherein the distal end of the optical element comprises a diffusion element, the diffusion element configured to provide uniform illumination.

22. The visualization needle of claim 1, further comprising an integrated articulation mechanism, the integrated articulation mechanism configured to provide movement to the distal end of the optical element.

23. The visualization needle of claim 22, wherein the distal end of the elongate tubular needle is configured to be curved or straightened by the integrated articulation mechanism.

24. The visualization needle of claim 23, wherein the integrated articulation mechanism comprises pull wires.

25. The visualization needle of claim 23, wherein the distal end of the elongate tubular needle is configured to rotate about the longitudinal axis.

26. The visualization needle of claim 1, wherein the distal end of the elongate tubular needle comprises an articulating tip, the articulating tip configured to move toward and away from the longitudinal axis, the articulating tip further configured to rotate about the longitudinal axis.

27. The visualization needle of claim 1, wherein the distal end of the elongate tubular needle is deflected away from the longitudinal axis, the distal end of the elongate tubular needle configured to rotate about the longitudinal axis.

28. The visualization needle of claim 1, wherein the distal end of the elongate optical element is configured to rotate about the longitudinal axis.

29. The visualization needle of claim 1, wherein the distal end of the elongate tubular needle is configured to rotate about the longitudinal axis.