HAND-HELD MINIMALLY DIMENSIONED DIAGNOSTIC DEVICE HAVING INTEGRATED DISTAL END VISUALIZATION

• US 20110009694A1
• Filed: 07/10/2009
• Published: 01/13/2011
• Est. Priority Date: 07/10/2009
• Status: Abandoned Application

• Current Assignee: Trice Medical, Inc.
• Original Assignee: Trice Medical, Inc.
• Inventors: OuYang, Xiaolong, Cybulski, James S., Schultz, Eric E.
• Application Number:
  US12/501,336
• Publication Number:
  US 20110009694A1
• Time in Patent Office: Days
• US Class Current: 600/109
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/00034 rechargeable
• CPC Class Codes: A61B 1/00042 for mechanical operation
• CPC Class Codes: A61B 1/00052 positioned at proximal end of the endoscope body
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00097 Sensors
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• CPC Class Codes: A61B 1/00183 for variable viewing angles
• CPC Class Codes: A61B 1/00193 adapted for stereoscopic vision
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• 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 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0607 for annular illumination
• 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 1/3135 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 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/320016 : Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 2017/00022 : Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00362 : Packages or dispensers for MIS instruments A61B2017/0479 takes precedence
• CPC Class Codes: A61B 2017/0046 : with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/320008 : Scrapers
• CPC Class Codes: A61B 2090/309 : using white LEDs
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2090/372 : Details of monitor hardware
• CPC Class Codes: A61B 2090/373 : using light, e.g. by using optical scanners
• CPC Class Codes: A61B 90/30 : Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

Hand-held minimally dimensioned diagnostic devices having integrated distal end visualization are provided. Also provided are systems that include the devices, as well as methods of using the devices, e.g., to visualize internal tissue of a subject.

Claims

1. An internal tissue visualization device, the device comprising:

(a) a hand-held control unit comprising a monitor; and

(b) an elongated member having a proximal end operatively coupled to the hand-held control unit and a minimally-dimensioned distal end having an integrated visualization sensor.

2. The device according to claim 1, wherein the minimally dimensioned distal end has an outer diameter that is 5 mm or less.

3. The device according to claim 2, wherein the minimally dimensioned distal end has an outer diameter that is 3 mm or less.

4. The device according to claim 1, wherein the integrated visualization sensor comprises a CMOS device.

5. The device according to claim 1, wherein the distal end of the elongated member further comprises an integrated illuminator.

6. The device according to claim 5, wherein the integrated illuminator comprises a configuration selected from the group consisting of a crescent configuration and a concentric configuration.

7. The device according to claim 1, wherein the elongated member comprises an annular wall configured to conduct light to the elongated member distal end from a proximal end source.

8. The device according to 7, wherein the proximal end source comprises a forward focused light emitting diode.

9. The device according to claim 8, wherein the forward focused light emitting diode is configured to direct light along the outer surface of the elongated member.

10. The device according to claim 1, wherein the elongated member comprises a fluid filled structure configured to conduct light to the elongated member distal end from a proximal end source.

11. The device according to 10, wherein the proximal end source comprises a forward focused light emitting diode.

12. The device according to claim 11, wherein the forward focused light emitting diode is configured to direct light along the outer surface of the elongated member.

13. The device according to claim 5, wherein the device is configured to reduce coupling of light directly from the integrated illuminator to the visualization sensor.

14. The device according to claim 13, wherein the device comprises a distal end polarized member.

15. The device according to claim 13, wherein the polarized member polarizes light from the integrated illuminator.

16. The device according to claim 13, wherein the polarized member filters light reaching the visualization sensor.

17. The device according to claim 1, wherein the proximal end of the elongated member is configured to be detachable from the hand-held control unit.

18. The device according to claim 17, wherein the device comprises a removable sterile covering attached to the proximal end of the elongated member that is configured to seal the hand-held control unit from the environment.

19. The device according to claim 18, wherein the hand-held control unit comprises a handle portion and a controller.

20. The device according to claim 19, wherein the sterile covering comprises a window portion configured to associate with the monitor and boot portion configured to associated with the controller.

21. The device according to claim 20, wherein the window portion is configured to provide for touch screen interaction with the monitor.

22. The device according to claim 21, wherein the sterile covering comprises a seal at a region associated with the proximal end of the hand-held control unit.

23. The device according to claim 1, wherein the monitor is configured to communicate wirelessly with another device.

24. The device according to claim 23, wherein the monitor is configured to be detachable from the hand-held control unit.

25. The device according to claim 1, wherein the elongated member comprises a distal end integrated non-visualization sensor.

26. The device according to claim 25, wherein the distal end integrated non-visualization sensor is a sensor selected from the group consisting of:

temperature sensors, pressure sensors, pH sensors, impedance sensors, conductivity sensors and elasticity sensors.

27. The device according to claim 25, wherein the sensor is deployable.

28. The device according to claim 1, wherein the elongated member comprises a lumen that extends for at least a portion of the elongated member.

29. The device according to claim 1, wherein the distal end of the elongated member comprises a tool selected from the group consisting of a low-profile biopsy tool and a low-profile cutting tool

30. The device according to claim 29, wherein the low-profile biopsy tool comprises an annular cutting member concentrically disposed about the distal end of the elongated member and configured to be moved relative to the distal end of the elongated member in a manner sufficient to engage tissue.

31. The device according to claim 1, wherein the integrated visualization sensor comprises an RF-shielded visualization module.

32. The device according to claim 1, wherein the elongated member is configured for distal end articulation.

33. The device according to claim 1, wherein the device comprises a stereoscopic image module.

34. The device according to claim 1, wherein the device comprises an image recognition module.

35. The device according to claim 1, wherein the device comprises a collimated laser.

36. A method of imaging an internal target tissue site of a subject, the method comprising:

(a) positioning the distal end of an internal tissue visualization device in operable relation to the internal target tissue site, where the device comprises;

(i) a hand-held control unit comprising a monitor; and

(ii) an elongated member having a proximal end operatively coupled to the hand-held control unit and a minimally-dimensioned distal end having an integrated visualization sensor; and

(b) visualizing the internal target tissue site with the visualization sensor.

37. The method according to claim 36, wherein the internal target tissue site comprises spinal tissue.

38. The method according to claim 37, wherein the device further comprises a distal end low-profile biopsy tool and the method further comprises obtaining a tissue biopsy with the low-profile biopsy tool.

39. A method of assembling an internal tissue visualization device, the method comprising operatively coupling a proximal end of an elongated member to a hand-held control unit, wherein the elongated member comprises a distal end integrated visualization sensor and the hand-held control unit comprises a monitor.

40. The method according to claim 39, wherein the method further comprises sealing the hand-held control unit inside of a removable sterile covering attached to the proximal end of the elongated member and configured to seal the hand-held control unit from the environment.

41. The method according to claim 40, wherein the hand-held control unit comprises a handle portion and a controller and the sterile covering comprises a window portion configured to associate with the monitor and boot portion configured to associated with the manual controller.

42. The method according to claim 41, wherein the method comprises sealing a proximal end of the sterile covering.