Method and system for enhanced imaging visualization of deep brain anatomy using infusion

• US 10,159,782 B2
• Filed: 09/18/2013
• Issued: 12/25/2018
• Est. Priority Date: 09/19/2012
• Status: Active Grant

• Current Assignee: University of Virginia
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Elias, William J., Bond, Aaron E., Gillies, George T.
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US14/429,592
• Publication Number:
  US 20150238685A1
• Time in Patent Office: 1,924 Days
• Field of Search: 600407-480
• CPC Class Codes: A61B 5/0042 for the brain
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/501 for diagnosis of the head, e.g. neuroimaging or craniography
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: G01R 33/285 Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR

Abstract

Provided is a method and system for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system. The method and system includes a catheter device with associated lumens having diagnostic agent ports for delivering the diagnostic agent (e.g., infusate) through the lumens and advancing the diagnostic agent so as to exit out from the lumens to at least a portion of the brain site and while sealing a portion of the brain site thereby preventing the exited diagnostic agent from travelling proximally beyond the sealing location, and at the same time imaging at least a portion of the brain site during at least a portion of the sealing duration so that the brain site can be visualized on a medical imaging system. The diagnostic agent (infusate) is able to highlight borders and internal patterns of the deep structures of the brain thereby enabling direct targeting. Ultimately this leads to reduced complications, enhanced therapy, and the elimination of the need for awake surgery. The method and system provides the capability heretofore not possible to visualize the small, often indistinct regions, which will greatly improve clinical outcomes with therapeutic interventions.

Claims

1. A catheter system for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system, said catheter system comprising:

a catheter device including a first lumen, said first lumen having a first lumen proximal region, a first lumen distal region, and a first lumen longitudinal region there between;

said first lumen configured to convey a diagnostic agent within said first lumen, and at least a portion of said first lumen having one or more ports configured to allow the conveyed diagnostic agent to exit from said first lumen to at least a portion of the brain site; and

wherein a portion of said catheter device having a cross-sectional area greater than portions of said catheter located proximally therefrom is configured to define a seal within at least a portion of the brain site to prevent the exited diagnostic agent from travelling proximally beyond the seal while at least a portion of the brain site can be visualized on a medical imaging system, and wherein the exited diagnostic agent exits distally beyond the seal through the one or more ports, wherein the one or more ports comprise a circumferentially arranged array of holes extending along a length of the first lumen distal region, distally beyond the seal.

2. The system of claim 1, further comprising:

a first lumen diagnostic agent, wherein said first lumen diagnostic agent comprises;

autologous cerebrospinal fluid (CSF).

3. The system of claim 1, further comprising:

a first lumen diagnostic agent, wherein said first lumen diagnostic agent comprises;

artificial cerebrospinal fluid (CSF).

4. The system of claim 1, further comprising:

a first lumen diagnostic agent, wherein said first lumen diagnostic agent comprises;

saline.

5. The system of claim 1, further comprising:

a first lumen diagnostic agent, wherein said first lumen diagnostic agent comprises an aqueous fluid.

6. The system of claim 5, wherein said aqueous fluid comprises at least one of the following:

lactated ringers, Dextran, Gadolinium diethylenetriamine penta-acetic acid (DTPA), Gadolinium-albumin, Phosphate Buffered Saline, and Albumin.

7. The system of claim 1, wherein said one or more ports comprise a dialysis-like membrane.

8. The system of claim 1, further comprising a system for delivering a second diagnostic agent, comprising:

a second lumen, said second lumen having a second lumen proximal region, a second lumen distal region, and a second lumen longitudinal region there between;

said second lumen configured to convey a second lumen agent within said second lumen, and at least a portion of said second lumen having one or more second lumen agent ports configured to allow the conveyed second lumen agent to exit from said second lumen to at least a portion of the brain site distally beyond the seal; and

wherein said seal is defined such as to prevent the exited second lumen agent from travelling proximally beyond the seal through the one or more second lumen ports, wherein the one or more second lumen ports comprise a circumferentially arranged array of holes extending along a length of the second lumen distal region, distally beyond the seal.

9. The system of claim 8, further comprising:

a second lumen diagnostic agent, wherein said second lumen agent comprises;

one or more therapeutic agents.

10. The system of claim 8, further comprising:

a second lumen diagnostic agent, wherein said second lumen agent comprises;

one or more diagnostic agents.

11. The system of claim 8, wherein the second lumen is configured to accommodate at least one of the following:

stylet, electrical lead, ancillary catheter, solid state sensor, electrical conductor, sampling tube, abrading tip, optical fiber, deep brain simulation (DBS) device, or pH sensor.

12. The system of claim 8, wherein the second lumen comprises at least one of the following at least partially disposed therein:

stylet, electrical lead, ancillary catheter, solid state sensor, electrical conductor, sampling tube, abrading tip, optical fiber, deep brain simulation (DBS) device, or pH sensor.

13. The system of claim 8, further comprising a system for conveying a third lumen material or device, comprising:

a third lumen, said third lumen having a third lumen proximal region, a third lumen distal region, and a third lumen longitudinal region there between; and

said third lumen configured to convey a third lumen material or device.

14. The system of claim 13, further comprising:

a third lumen device at least partially disposed therein.

15. The system of claim 14, wherein said third lumen device comprises at least one of the following:

stylet, electrical lead, ancillary catheter, solid state sensor, electrical conductor, sampling tube, abrading tip, optical fiber, deep brain simulation (DBS) device, or pH sensor.

16. The system of claim 13, wherein said system further comprises:

a third lumen material at least partially disposed therein.

17. The system of claim 16, wherein said third lumen material comprises at least one of the following:

one or more diagnostic agents and one more therapeutic agents.

18. The system of claim 8, wherein said brain site includes the parenchyma.

19. The system of claim 8, wherein said brain site includes within the cerebrovasculature.

20. The system of claim 1, wherein the portion of said catheter device having the greater cross-section area includes at least in part an expandable component in communication with said catheter device.

21. The system of claim 20, wherein said expandable component is axially located at a portion of said first lumen distal region.

22. The system of claim 20, wherein said catheter device comprises a first lumen distal tip, and wherein said expandable component is axially located beginning at said first lumen distal tip and axially extending to a portion of said first lumen distal region.

23. The system of claim 20, wherein said expandable component includes at least one of a balloon and inflatable compartment.

24. The system of claim 20, wherein said expandable component has a pre-formed shape for expansion or inflation.

25. The system of claim 1, wherein said medical imaging system comprises at least one of the following:

magnetic resonance imaging systems, computed tomography (CT), fluoroscopy, ultrasound, PET scanning, nuclear medicine camera, other radiological systems, or other biomedical imaging systems.

26. The system of claim 1, wherein said catheter device is adapted to be visible on a medical imaging system.

27. The system of claim 26, wherein said medical imaging system comprises at least one of the following:

magnetic resonance imaging systems, computed tomography (CT), fluoroscopy, ultrasound, PET scanning, nuclear medicine camera, other radiological systems, or other biomedical imaging systems.

28. The system of claim 1, further comprising:

a medical imaging system; and

wherein said catheter device is adapted to be visible on said medical imaging system.

29. The system of claim 28, wherein said medical imaging system comprises at least one of the following:

magnetic resonance imaging system, computed tomography (CT) system, fluoroscopy system, ultrasound system, PET scanning system, nuclear medicine camera system other radiological system, or other biomedical imaging system.

30. A method for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system, said method comprising:

providing a catheter device, said catheter device including a first lumen, said first lumen having a first lumen proximal region, a first lumen distal region, and a first lumen longitudinal region there between, wherein at least of a portion of said first lumen has one or more diagnostic agent ports;

delivering the diagnostic agent through said first lumen;

advancing the diagnostic agent from said first lumen to exit out from said first lumen to at least a portion of the brain site;

sealing a portion of the brain site, wherein said diagnostic agent exits distally beyond the sealing location and said sealing prevents the exited diagnostic agent from travelling proximally beyond the sealing location through the one or more ports, wherein the one or more ports comprise a circumferentially arranged array of holes extending along a length of the first lumen distal region, distally beyond the sealing location; and

imaging at least a portion of the brain site during at least a portion of the sealing duration so that said at least a portion of the brain site can be visualized on a medical imaging system.

31. The method of claim 30, wherein said first lumen diagnostic agent comprises:

autologous cerebrospinal fluid (CSF).

32. The method of claim 30, wherein said first lumen diagnostic agent comprises:

artificial cerebrospinal fluid (CSF).

33. The method of claim 30, wherein said first lumen diagnostic agent comprises:

saline.

34. The method of claim 30, wherein said first lumen diagnostic agent comprises an aqueous fluid.

35. The method of claim 34, wherein said aqueous fluid comprises at least one of the following:

lactated ringers, Dextran, Gadolinium diethylenetriamine penta-acetic acid (DTPA), Gadolinium-albumin, Phosphate Buffered Saline, and Albumin.

36. The method of claim 30, further comprising advancing at least one of the following into said first lumen:

stylet, electrical lead, ancillary catheter, solid state sensor, electrical conductor, sampling tube, abrading tip, optical fiber, deep brain simulation (DBS) device, or pH sensor.

37. The method of claim 30, wherein said one or more diagnostic agent ports comprise a dialysis-like membrane.

38. The method of claim 30, wherein said catheter further includes a second lumen, said second lumen having a second lumen proximal region, a second lumen distal regional, and a second lumen longitudinal region there between, and wherein the method further comprises:

delivering the second lumen agent through said second lumen; and

advancing the second lumen agent from said second lumen to exit out from said second lumen to at least a portion of the brain site.

40. The method of claim 38, wherein said second lumen agent comprises:

one or more therapeutic agents.

41. The method of claim 38, wherein said second lumen agent comprises:

one or more diagnostic agents.

42. The method of claim 38, further comprising advancing at least one of the following into said second lumen:

stylet, electrical lead, ancillary catheter, solid state sensor, electrical conductor, sampling tube, abrading tip, optical fiber, deep brain simulation (DBS) device, or pH sensor.

43. The method of claim 38, wherein said brain site includes the parenchyma.

44. The method of claim 38, wherein said brain site includes within the cerebrovasculature.

45. The method of claim 30, wherein said catheter further comprises a third lumen, said third lumen having a third lumen proximal region, a third lumen distal region, and a third lumen longitudinal region there between, and wherein the method further comprises:

providing a third lumen material or device through said third lumen.

46. The method of claim 45, wherein the third lumen device comprises one of the following:

stylet, electrical lead, ancillary catheter, solid state sensor, electrical conductor, sampling tube, abrading tip, optical fiber, or pH sensor.

47. The method of claim 45, wherein the third lumen material comprises one of the following:

one or more diagnostic agents and one more therapeutic agents.

48. The method of claim 30, wherein said sealing includes expanding an expandable component.

49. The method of claim 48, wherein said expandable component includes at least one of a balloon and inflatable compartment.

50. The method of claim 48, wherein said expandable component has a pre-formed shape for expansion or inflation.

51. The method of claim 30, wherein said sealing occurs at a portion of said first lumen distal region.

52. The method of claim 30, wherein said catheter device comprises a first lumen distal tip, and wherein said sealing occurs axially located beginning at said first lumen distal tip and axially extending to a portion of said first lumen distal region.

53. The method of claim 30, wherein said imaging comprises at least one of the following:

magnetic resonance imaging, computed tomography (CT), fluoroscopy, ultrasound, PET scanning, nuclear medicine camera, other radiological systems, or other biomedical imaging.

54. The method of claim 30, further comprising imaging at least a portion of said catheter device.

55. The method of claim 54, wherein said imaging of at least a portion of said catheter device comprises at least one of the following:

magnetic resonance imaging, computed tomography (CT), fluoroscopy, ultrasound, PET scanning, nuclear medicine camera, other radiological systems, or other biomedical imaging methods.

39. The method of 38, further comprising:

sealing a portion of the brain site, wherein said sealing prevents the second lumen agent from travelling proximally beyond the sealing location.

56. A catheter system for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system for purpose of treating a neurologic disorder of the subject, said catheter system comprising:

a catheter device including a first lumen, said first lumen having a first lumen proximal region, a first lumen distal region, and a first lumen longitudinal region there between;

wherein said first lumen is configured to convey a diagnostic agent within said first lumen, and at least a portion of said first lumen has one or more ports configured to allow the conveyed diagnostic agent to exit from said first lumen to at least a portion of the brain site;

wherein a portion of said catheter device having a cross-sectional area greater than portions of said catheter located proximally therefrom is configured to define a seal within at least a portion of the brain site to prevent the exited diagnostic agent from travelling proximally beyond the seal while at least a portion of the brain site can be visualized on a medical imaging system, and wherein the exited diagnostic agent exits distally beyond the seal through the one or more ports, wherein the one or more ports comprise a circumferentially arranged array of holes extending along a length of the first lumen distal region, distally beyond the seal; and

an electrical lead or deep brain simulation (DBS) device at least partially disposed in said first lumen for applying electrical stimulation by use of said electrical lead or DBS, to a site in the brain for providing a DBS.

57. The system of claim 56, wherein said neurologic disorder comprises at least one of the following:

Parkinson'"'"'s disease, tremor, epilepsy, neurodegenerative conditions or diseases, Alzheimer'"'"'s, seizures, paralysis, or psychiatric disease.

58. A catheter system for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system for purpose of treating a neurologic disorder of the subject, said catheter system comprising:

a catheter device including a first lumen, said first lumen having a first lumen proximal region, a first lumen distal region, and a first lumen longitudinal region there between;

wherein said first lumen is configured to convey a diagnostic agent within said first lumen, and at least a portion of said first lumen has one or more ports configured to allow the conveyed diagnostic agent to exit from said first lumen to at least a portion of the brain site;

wherein a portion of said catheter device having a cross-sectional area greater than portions of said catheter located proximally therefrom is configured to define a seal within at least a portion of the brain site to prevent the exited diagnostic agent from travelling proximally beyond the seal while at least a portion of the brain site can be visualized on a medical imaging system, and wherein the exited diagnostic agent exits distally beyond the seal through the one or more ports, wherein the one or more ports comprise a circumferentially arranged array of holes extending along a length of the first lumen distal region, distally beyond the seal;

a second lumen including a second lumen proximal region, a second lumen distal region, and a second lumen longitudinal region there between; and

an electrical lead or deep brain simulation (DBS) device at least partially disposed in said second lumen for applying electrical stimulation by use of said electrical lead or DBS, to a site in the brain for providing a DBS.

59. The system of claim 58, wherein said neurologic disorder comprises at least one of the following:

Parkinson'"'"'s disease, tremor, epilepsy, neurodegenerative conditions or diseases, Alzheimer'"'"'s, seizures, paralysis, or psychiatric disease.

60. A method for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system for purpose of treating a neurologic disorder of the subject, said method comprising:

providing a catheter device, said catheter device including a first lumen, said first lumen having a first lumen proximal region, a first lumen distal region, and a first lumen longitudinal region there between, at least of a portion of said first lumen having one or more diagnostic agent ports;

delivering the diagnostic agent through said first lumen;

advancing the diagnostic agent from said first lumen to exit out from said first lumen to at least a portion of the brain site;

sealing a portion of the brain site, wherein said diagnostic agent exits distally beyond the sealing location and said sealing prevents the exited diagnostic agent from travelling proximally beyond the sealing location through the one or more ports, wherein the one or more ports comprise a circumferentially arranged array of holes extending along a length of the first lumen distal region, distally beyond the sealing location;

imaging at least a portion of the brain site during at least a portion of the sealing duration so that said at least a portion of the brain site can be visualized on a medical imaging system;

delivering an electrical lead or deep brain simulation (DBS) device into said first lumen; and

applying electrical stimulation by use of said electrical lead or DBS, to a site in the brain for providing the DBS.

61. The method of claim 60, wherein said neurologic disorder comprises at least one of the following:

Parkinson'"'"'s disease, tremor, epilepsy, neurodegenerative conditions or diseases, Alzheimer'"'"'s, seizures, paralysis, or psychiatric disease.

62. A method for delivering a diagnostic agent to a site in the brain of a subject for imaging at least a portion of the brain site on a medical imaging system for purpose of treating a neurologic disorder of the subject, said method comprising:

providing a catheter device, said catheter device including a first lumen, said first lumen having a first lumen proximal region, a first lumen distal region, and a first lumen longitudinal region there between, at least of a portion of said first lumen having one or more diagnostic agent ports;

delivering the diagnostic agent through said first lumen;

advancing the diagnostic agent from said first lumen to exit out from said first lumen to at least a portion of the brain site;

sealing a portion of the brain site, wherein said diagnostic agent exits distally beyond the sealing location and said sealing prevents the exited diagnostic agent from travelling proximally beyond the sealing location through the one or more ports, wherein the one or more ports comprise a circumferentially arranged array of holes extending along a length of the first lumen distal region, distally beyond the sealing location;

imaging at least a portion of the brain site during at least a portion of the sealing duration so that said at least a portion of the brain site can be visualized on a medical imaging system;

wherein said catheter further includes a second lumen having a second lumen proximal region, a second lumen distal region, and a second lumen longitudinal region there between;

delivering an electrical lead or deep brain simulation (DBS) device into said second lumen; and

applying electrical stimulation by use of said electrical lead or DBS, to a site in the brain for providing the DBS.

63. The method of claim 62, wherein said neurologic disorders comprises at least one of the following:

Parkinson'"'"'s disease, tremor, epilepsy, neurodegenerative conditions or diseases, Alzheimer'"'"'s, seizures, paralysis, or psychiatric disease.