Diagnosing and performing interventional procedures on tissue in vivo

• US 6,296,608 B1
• Filed: 07/08/1996
• Issued: 10/02/2001
• Est. Priority Date: 07/08/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Banik, Michael S., Daniels, Douglas J.
• Primary Examiner(s): Leubecker, John P.
• Application Number:
  US08/679,425
• Time in Patent Office: 1,912 Days
• Field of Search: 600/104, 600/476, 600/478, 600/473, 600/475, 600/477, 600/564
• US Class Current: 600/104
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• 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 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• 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 8/4461 : Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe

Abstract

A catheter for diagnosing and performing an interventional procedure on tissue has an elongated catheter shaft, and optical fibers, extending through the catheter shaft, for transmitting light to tissue located at a distal end of the catheter and conveying light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue. An interventional device is located at the distal end of the catheter for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue. An assembly for imaging and performing an interventional procedure on tissue has an endo scope in combination with an endoscopically insertable catheter having an ultrasound imaging device for imaging a tissue structure located at a distal end of the endoscope so as to enable the depth of penetration of the tissue structure to be displayed, and an endoscopically insertable interventional device for engaging the tissue structure imaged by the ultrasound imaging device.

Claims

1. A catheter, comprising:

an elongated catheter shaft defining at least two lumens and including a distal end;

a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at a distal end of the catheter shaft;

a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue, wherein said second optical fiber and said first optical fiber are discrete fibers and at least one of the fibers includes a viewing device for converting a second conveyed light back from the tissue into a visual observation image of the tissue; and

an interventional device located at the distal end of the catheter shaft for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue, wherein said interventional device is physically separable from said first and second optical fibers.

2. The catheter of claim 1, wherein the interventional device comprises a scalpel.

3. The catheter of claim 1, wherein the interventional device comprises forceps jaws.

4. The catheter of claim 1, wherein the interventional device comprises a snare.

5. The catheter of claim 1, wherein the interventional device comprises a scissors.

6. The catheter of claim 1, wherein the interventional device comprises a needle.

7. The catheter of claim 6, wherein the needle is constructed to inject a marking fluid into the tissue.

8. The catheter of claim 6, wherein the needle is constructed to inject a chemical ablation fluid into the tissue.

9. The catheter of claim 6, wherein the needle is constructed to cut the tissue.

10. The catheter of claim 6, wherein the needle is constructed to apply an adhesive material to the tissue.

11. The catheter of claim 6, wherein the needle is constructed to convey a fluid to the tissue useful for enabling visual observation of the tissue.

12. The catheter of claim 6, wherein the needle is constructed to apply a vacuum to the tissue.

13. The catheter of claim 1, wherein the catheter shaft is constructed to be inserted through the working channel of an endoscope.

14. The catheter of claim 1, wherein at least one of the optical fibers is further constructed for conveying visualization light to the tissue.

15. A method of diagnosing and performing an interventional procedure on tissue, comprising the steps of:

inserting into a lumen of a body of a living being a catheter having an elongated shaft defining at least two lumens and including a distal end, a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at the distal end of the catheter, a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system, and an interventional device, wherein said first optical fiber and said second optical fiber are discrete fibers, and said interventional device is physically separable from said first and second optical fibers;

transmitting light through the first optical fiber to tissue located at the distal end of the catheter;

conveying light back from the tissue through the second optical fiber for analysis by a spectroscopic diagnosis system;

conveying light back from the tissue through at least one of the optical fibers for visual observation of the tissue;

diagnosing the tissue with the spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue; and

engaging, with the interventional device, the tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue.

16. The method of claim 15, wherein the interventional procedure comprises marking the tissue by injecting a marking fluid into the tissue with the interventional device.

17. The method of claim 16, wherein the marking fluid is india ink.

18. The method of claim 16, further comprising the steps of:

withdrawing the catheter having the optical fibers and the interventional device;

inserting into the body of the living being a second catheter having a second interventional device located at its distal end; and

engaging, with the second interventional device of the second catheter, the tissue diagnosed by the spectroscopic diagnosis system in order to perform another interventional procedure on the tissue.

19. The method of claim 15, wherein the step of diagnosing the tissue using the spectroscopic diagnosis system comprises determining whether an interventional procedure should be performed on the tissue.

20. The method of claim 15, wherein the interventional procedure comprises removing tissue for biopsy analysis.

21. The method of claim 15, wherein the interventional procedure comprises removing tissue diagnosed by the spectroscopic diagnosis system as being unhealthy.

22. The method of claim 15, wherein the lumen comprises an alimentary lumen.

23. The method of claim 15, wherein the lumen comprises a pulmonary lumen.

24. The method of claim 15, wherein the step of diagnosing the tissue further comprises determining whether the tissue is a tumor.

25. The method of claim 24, wherein the step of diagnosing the tissue further comprises determining whether the tumor is cancerous.

26. The method of claim 15, further comprising the step of inserting through the lumen of the body of the living being an endoscope having a working channel, and wherein the step of inserting the catheter into the body of the living being comprises inserting the catheter into the working channel of the endoscope.

27. The method of claim 15, further comprising the step of conveying visualization light to the tissue through at least one of the optical fibers.

28. The method of claim 15, further comprising the step of conveying a fluid through the catheter shaft to the tissue usefull for enabling visual observation of the tissue.

29. The method of claim 15, further comprising the step of applying a vacuum to the tissue through the catheter shaft.

30. An assembly comprising:

an endoscope;

an enlongated catheter shaft defining at least two lumens and including a distal end, and constructed to be insertable through a working channel or the endoscope;

a first optical fiber, removably insertable into one of the at least two two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at the distal end of the catheter shaft;

a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue, wherein said second optical fiber and said first optical fiber are discrete fibers and at least one of the fibers includes a viewing device for converting a second conveyed light back from the tissue into a visual observation image of the tissue; and

an interventional device, constructed to be insertable through a working channel of an endoscope, for engaging tissue diagnosed by the spectroscopic diagnosis system in order to preform the interventional procedure on the tissue, wherein said interventional device is physically seperable from said first and second optical fibers.

31. The assembly of claim 30 wherein the interventional device is located at the distal end of the catheter shaft having the optical fibers.

32. A method of diagnosing and performing an interventional procedure on tissue, comprising the steps of:

inserting an endoscope through a lumen of a body of a living being;

inserting through a working channel of the endoscope a catheter having an elongated shaft defining at least two lumens and including a distal end, a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at the distal end of the catheter, a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system wherein said first optical fiber and said second optical fiber are discrete fibers;

transmitting light through the first optical fiber to tissue located at the distal end of the catheter;

conveying light back from the tissue through the second optical fiber for analysis by a spectroscopic diagnosis system;

conveying light back from the tissue through at least one of the optical fibers for visual observation of the tissue;

diagnosing the tissue with the spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue; and

engaging, with an interventional device insertable through a working channel of the endoscope, the tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue, wherein said interventional device is physically separable from said first and second optical fibers.