METHOD AND APPARATUS FOR IDENTIFYING AND TREATING MYOCARDIAL INFARCTION

• US 20080125634A1
• Filed: 06/14/2007
• Published: 05/29/2008
• Est. Priority Date: 06/14/2006
• Status: Abandoned Application

• Current Assignee: CorNova, Inc.
• Original Assignee: CorNova, Inc.
• Inventors: Tang, Jing, Ryan, S. Eric
• Application Number:
  US11/762,956
• Publication Number:
  US 20080125634A1
• Time in Patent Office: Days
• US Class Current: 600/342
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/2238 with means for selectively laterally deflecting the tip of the fibre
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

A method and apparatus for analyzing and treating internal tissues and, in particular, tissues affected by myocardial infarct. The apparatus includes a catheterized device integrating an optical probe and treatment delivery system. The probe component includes fiber optic lines that can be used in conjunction with infrared spectroscopy to analyze various characteristics of tissues, including chemical, blood, and oxygen content, in order to locate those tissues associated with myocardial infarct, to determine the best location for applying treatment, and to monitor treatment and its effects. Physically integrated with the probe component is a treatment component for delivering treatments including stem cell and gene therapy, known for having beneficial effects on tissues associated with myocardial infarct. A control system coordinates operation of the catheter, including performing chemometric analysis with the use of model data, and for providing control and visual feedback to an operator.

Claims

1. An apparatus for probing and treating internal body organs comprising:

a catheter having a fiber probe arrangement and one or more treatment lumens; and

an analysis and treatment control system connected to said catheter, said analysis and control system programmed to characterize and locate damaged tissue via said fiber probe arrangement and to treat said damaged tissue with said one or more treatment lumens.

2. The apparatus of claim 1 further comprising a spectrometer connected to said fiber probe arrangement.

3. The apparatus of claim 1 wherein the distal end of said catheter comprises a needle tip inserter.

4. The apparatus of claim 3 wherein said needle tip inserter incorporates the probe ends of one or more fibers of said fiber probe arrangement and a dispersal port for said one or more treatment lumens.

5. The apparatus of claim 3 wherein said needle tip inserter is partially retractable within said catheter so as to ease the advancement of said catheter in a patient while permitting optical analysis.

6. The apparatus of claim 1 wherein the analysis and treatment control system is programmed to analyze spectroscopic data, the analysis of the spectroscopic data including distinguishing the types and conditions of tissue within and surrounding a patient'"'"'s heart.

7. The apparatus of claim 6 wherein the spectroscopic data is selected according to predetermined wavelength bands that distinguish levels of at least one of particles, gas, and liquid contained in the tissue.

8. The apparatus of claim 6 wherein distinguishing the types and conditions of tissue within and surrounding a patient'"'"'s heart includes characterizing and locating tissues associated with myocardial infarct.

9. The apparatus of claim 8 wherein the characterizing and locating tissues associated with myocardial infarct comprises identifying an area for treatment of myocardial infarction by locating and targeting an affected area surrounding a region of necrotic tissue.

10. The apparatus of claim 8 wherein characterizing and locating the tissues associated with myocardial infarct includes detecting levels of at least one of fibrosis, calcification, or oxygen content.

11. The apparatus of claim 10 wherein the analysis of said spectroscopic data includes chemometric analysis of said spectroscopic data in relation to previously obtained and stored spectroscopic data.

12. The apparatus of claim 11 wherein the chemometric analysis involves at least one technique, the at least one technique including Principle Component Analysis (PCA) with Mahalanobis Distance, PCA with K-nearest neighbor, PCA with Euclidean Distance, Partial Least Squares Discrimination Analysis, augmented Residuals, bootstrap error-adjusted single-sample technique, or Soft Independent Modeling of Class Analogy.

13. The apparatus of claim 10 wherein said analysis and control system is configured to perform spectroscopic scans across wavelengths within the range of approximately 300 to 2500 nanometers.

14. The apparatus of claim 6 wherein the analysis of the spectroscopic data includes estimating relative distances between a distal end of said fiber probe arrangement and tissue analyzed by said spectrometer.

15. The apparatus of claim 14 wherein estimating said relative distances includes comparing the magnitudes of spectroscopic absorbance peaks associated with tissue or blood with magnitudes similarly obtained from previously stored spectroscopic absorbance data.

16. The apparatus of claim 15 wherein estimating said relative distances includes comparing the magnitudes of the spectroscopic absorbance peaks obtained at different predetermined positions of said catheter relative to said tissue or blood.

17. The apparatus of claim 14 wherein estimating said relative distances includes comparing spectroscopic absorbance peaks associated with collection fibers having terminating ends separated longitudinally from each other at a predetermined distance.

18. The apparatus of claim 1 wherein said one or more treatment lumens comprises a conduit for delivering a fluid solution to damaged tissue.

19. The apparatus of claim 1 wherein said one or more treatment lumens comprises a conduit for delivering therapeutic laser energy.

20. The apparatus of claim 1 wherein said catheter further incorporates one or more sensors.

21. The apparatus of claim 20 wherein said one or more sensors include at least one temperature gauge, pH meter, oxygenation meter, or water content meter.

22. The apparatus of claim 1 wherein said catheter further includes a biopsy sampler.

23. The apparatus of claim 3 wherein the distal end of said catheter further comprises a guidewire branching from said catheter apart from said needle tip.

37. The method of claim 3 wherein the spectroscopic data is selectively collected in sub-ranges of radiation spanning approximately 300 to 1375 nanometers, 1550 to 1850 nanometers, and 2100 to 2500 nanometers.

24. A catheter for probing and treating myocardial infarct, said catheter comprising:

a fiber probe arrangement;

one or more treatment lumens; and

a distal end having a needle injection inserter, said inserter integrating one or more fiber probe ends from said fiber probe arrangement and one or more delivery ports from said one or more treatment lumens.

25. The catheter of claim 24 further comprising an angle control wire for adjusting the angle of the distal end of said catheter.

26. The apparatus of claim 24 further comprising a gripping element about the proximate portion of said catheter, said gripping element having one or more control elements for controlling aspects of positioning said catheter or for delivering treatment.

27. A method for treating body tissue, said method comprising:

inserting into a patient a catheter integrated with a fiber optic analysis probe and a treatment delivery conduit;

characterizing and locating the body tissue to be treated with radiation delivered and collected through said fiber optic analysis probe;

positioning said catheter to deliver treatment with information obtained through said fiber optic analysis probe; and

delivering a treatment through said treatment delivery conduit.

28. The method of claim 27 wherein the body tissue to be treated is associated with myocardial infarct.

29. The method of claim 28 wherein locating the body tissue associated with myocardial infarct to be treated includes locating and targeting an affected area surrounding a region of necrotic tissue for the step of delivering a treatment through the treatment delivery conduit.

30. The method of claim 28 wherein characterizing and locating the body tissue associated with myocardial infarct to be treated comprises:

obtaining spectroscopic data from radiation delivered to and collected from said tissue to be treated via said fiber optic analysis probe; and

comparing said spectroscopic data with previously stored data characteristic of tissues within and around a patient'"'"'s heart in order to identify the type of tissue being analyzed and to locate the position of said tissue being analyzed relative to said catheter.

31. The method of claim 30 wherein characterizing the tissue to be treated involves comparing levels of at least one of gases, fluids, and compounds within typical normal tissues as compared to at least one of gases, fluids, and compounds within tissues associated with myocardial infarct.

32. The method of claim 30 wherein obtaining spectroscopic data comprises at least one of the methods including diffuse-reflectance spectroscopy, fluorescence spectroscopy, Raman spectroscopy, scattering spectroscopy, optical coherence reflectometery, and optical coherence tomography.

33. The method of claim 30 wherein said at least one of gases, fluids, and compounds are selected from the group including collagen, calcium, oxygen, hemoglobin, and myoglobin.

34. The method of claim 30 wherein characterizing the tissue to be treated involves chemometric analysis selected from the group of techniques consisting of Principle Component Analysis (PCA) with Mahalanobis Distance, PCA with K-nearest neighbor, PCA with Euclidean Distance, Partial Least Squares Discrimination Analysis, augmented Residuals, bootstrap error-adjusted single-sample technique, and Soft Independent Modeling of Class Analogy.

35. The method of claim 30 wherein said radiation delivered and collected through said fiber optic probe is restricted to selectively narrow spans of wavelengths associated with identifying said tissues.

36. The method of claim 35 wherein the spectroscopic data is obtained from radiation spanning wavelengths between approximately 300 to 2500 nanometers.

38. The method of claim 35 wherein radiation is delivered to tissue or blood at a narrow range including 380 nanometers and scanned across a narrow range including 320 nanometers in order to identify the presence of collagen.

39. The method of claim 30 wherein locating tissues in relation to said catheter includes pre-operative steps of analyzing and comparing the wavelengths and magnitudes of spectroscopic absorbance peaks associated with tissues and blood surrounding said tissues.

40. The method of claim 39 wherein the wavelengths and magnitudes of spectroscopic absorbance peaks associated with tissues and blood is compared with previously obtained and stored spectroscopic absorbance data associated with a catheter approaching similar tissues in a blood medium.

41. The method of claim 27 wherein the distal end of said catheter includes an inserter integrated with terminating ends of said fiber optic probe and delivery conduit, said inserter suitably sharp for perforating targeted tissue.

42. The method of claim 41 wherein, during positioning of said catheter for delivery of treatment, said integrated inserter remains at least partially retracted in said catheter prior to perforation into tissue targeted for treatment and said fiber optic probe is functional while said inserter is at least partially retracted.

43. The method of claim 42 wherein final positioning of said catheter for delivery of treatment includes extending said inserter out from the distal end of said catheter into the targeted tissue.

44. The method of claim 43 wherein, prior to and during extension of said inserter, a wall of myocardial tissue before which said inserter is positioned is concurrently analyzed and monitored to prevent complete perforation of said inserter through the entire wall of said myocardial tissue.

45. The method of claim 44 wherein the prevention of complete perforation includes monitoring the contents of tissue for a layer of pericardial fat positioned beyond said wall of myocardial tissue.

46. The method of claim 27 wherein delivering treatment through said treatment delivery conduit comprises the injection of therapeutic agents.

47. The method of claim 27 wherein delivering treatment through said treatment delivery conduit comprises the injection of chemical agents.

48. The method of claim 46 wherein delivering treatment through said treatment delivery conduit comprises the delivery of gene therapy agents.

49. The method of claim 46 wherein delivering treatment through said treatment delivery conduit comprises injecting stem cell therapy agents.

50. The method of claim 46 wherein delivering treatment through said treatment delivery conduit comprises injecting cytotherapy agents.

51. The method of claim 46 wherein one or more of a selection of therapy agents are chosen and delivered based on data collected during characterizing and locating the body tissue to be treated.

52. The method of claim 46 wherein the release of agents is monitored with said fiber optic probe and controlled using feedback from said monitoring.

53. The method of claim 27 wherein delivering treatment through said treatment delivery conduit comprises delivering therapeutic laser energy.

54. The method of claim 53 wherein delivering therapeutic laser energy comprises canalizing infarct tissue for purposes of revascularization.

55. The method of claim 27 wherein said catheter is introduced into said patient in accordance with a percutaneous transluminal angioplasty.

56. The method of claim 27 wherein said catheter is introduced into said patient in accordance with percutaneous endoventricular delivery.