Claims
- 1. A coronary dialysis system, for a patient comprising a coronary arterial tree, a cardiac venous system, and a cardiac capillary system, the coronary dialysis system comprising:
a. a multi-chambered dialysis machine, comprising a fluid inlet in fluid communication with a fluid outlet, the multi-chambered dialysis machine adapted to separate plasma from blood and process the blood to at least one of (i) remove an unwanted substance from the blood or (ii) add a desired substance to the blood; b. a collecting catheter system in fluid communication with the patient and the fluid inlet; and c. a coronary artery perfusing catheter in fluid communication with the patient and the fluid outlet.
- 2. The coronary dialysis system of claim 1, further comprising at least one of (i) an arterial sheath adapted to receive a plurality of catheters therethrough or (ii) a vehicle catheter adapted to pass through the arterial sheath, the vehicle catheter adapted to receive a plurality of catheters therethrough.
- 3. The coronary dialysis system of claim 1, wherein the multi-chambered dialysis machine further comprises:
a. a blood separation chamber in fluid communication with the input and output; and b. a blood processing chamber in fluid communication with the input, the output, and the blood separation chamber.
- 4. The coronary dialysis system of claim 3, wherein the blood separation chamber further comprises:
a. a first hollow fiber module adapted to provide plasma differential precipitation; b. an acidifier in fluid communication with the first hollow fiber module; c. a heparinizer in fluid communication with the acidifier; d. a second hollow fiber module in fluid communication with the heparinizer; and e. an adsorption column in fluid communication with the second hollow fiber module.
- 5. The coronary dialysis system of claim 3, wherein the blood separation chamber is adapted to accomplish at least one of (i) immune precipitation or (ii) immunoabsorption using at least one of (iii) micro beads or (iv) a nanoparticle.
- 6. The coronary dialysis system of claim 3, wherein:
a. the blood separation chamber further comprises at least one of (i) a plasmaphaeresis chamber or (ii) an aphaeresis chamber; and b. the blood processing chamber further comprises at least one of (i) an oxygenator, (ii) an enricher, (iii) a heater, or (iv) a pump.
- 7. The coronary dialysis system of claim 6, wherein the heater is adapted to warm blood to between around 35° C. to around 45° C.
- 8. The coronary dialysis system of claim 6, wherein the enricher is adapted to provide at least one of (i) a predetermined dose of a drug or (ii) a therapeutic agent.
- 9. The coronary dialysis system of claim 2, wherein a length of the arterial sheath is sufficient to allow a catheter disposed within the arterial sheath to be introduced via a femoral artery to an aortic root.
- 10. The coronary dialysis system of claim 2, wherein the vehicle catheter further comprises an inflatable balloon disposed proximate a distal end of the vehicle catheter, the inflatable balloon adapted to engage against the ascending aorta.
- 11. The coronary dialysis system of claim 1, wherein a length of a catheter is sufficient to allow the catheter to be introduced via a femoral artery to a coronary ostium, the catheter comprising at least one of (i) the coronary perfusing catheter or (ii) the perfusion catheter.
- 12. The coronary dialysis system of claim 1, wherein the perfusion catheter further comprises a tubular portion, the tubular portion adapted to provide at least one of (i) a sufficient internal diameter to allow a flow rate of about 150-250 ml/min or greater for processed blood or (ii) coronary perfusion pressure of about 100-150 mmHg.
- 13. The coronary dialysis system of claim 1, wherein a distal end of the perfusion catheter comprises a pre-shaped curvature adapted to allow engagement of the distal end of the perfusion catheter into a coronary artery ostium.
- 14. The coronary dialysis system of claim 13, wherein the pre-shaped curvature is adapted to be compatible with an aortic root.
- 15. The coronary dialysis system of claim 1, wherein each of the collecting catheter and the perfusion catheter further comprise an inflatable balloon disposed proximate a distal end of that catheter.
- 16. The coronary dialysis system of claim 15, wherein the inflatable balloon is adapted to at least one of (i) substantially completely block a coronary ostium to isolate the coronary system from systemic circulation or (ii) not completely block the coronary ostium.
- 17. The coronary dialysis system of claim 16, wherein, upon inflation, the inflatable balloon adapted to not completely block the coronary ostium comprises at least one of (i) a ring shape or (ii) a butterfly shape.
- 18. The coronary dialysis system of claim 1, wherein the perfusing collecting catheter further comprises:
a. a changeable curvature; and b. a changeable tip angulation.
- 19. The coronary dialysis system of claim 18, wherein curvature and tip angulation may be changed implementing fibers along the length of the catheter to facilitate coronary engagement.
- 20. The coronary dialysis system of claim 1, wherein:
a. the collecting catheter is adapted to be engaged in the coronary sinus ostium to collect venous blood from the patient; and b. the perfusion catheter is adapted to be engaged into the coronary artery ostia of the patient.
- 21. The coronary dialysis system of claim 11, wherein the perfusion catheter further comprises a sensor.
- 22. The coronary dialysis system of claim 21, wherein the sensor further comprises:
a. a temperature sensor disposed proximate a wall of the tubular component; and b. a pressure sensor disposed proximate the wall of the tubular component.
- 23. The coronary dialysis system of claim 22, further comprising:
a. a monitoring system for detection of blood temperature and pressure respectively, the monitoring system operatively in communication with at least one of (i) the temperature sensor or (ii) the pressure sensor.
- 24. The coronary dialysis system of claim 12, wherein the perfusion catheter further comprises an inflation channel disposed proximate a wall of the tubular component.
- 25. The coronary dialysis system of claim 11, wherein:
a. the vehicle catheter further comprises a pressure channel adapted to monitor blood pressure within the ascending aorta; and b. the perfusion catheter comprises a plurality of perfusion catheters contained at least partially within the vehicle catheter. Catheter Config
- 26. A catheter system for coronary dialysis, comprising: %
a. a collecting catheter, comprising:
i. an inlet adapted to receive blood from a coronary site in a patient; and ii. an outlet, adapted to deliver blood to a dialysis machine; and b. a coronary artery perfusing catheter; comprising:
i. an inlet adapted to receive blood from the dialysis machine; and ii. an outlet, adapted to deliver blood to a coronary site in a patient.
- 27. The catheter system of claim 26, wherein each of the coronary perfusing catheter and the perfusion catheter catheter is sufficient to allow the catheter to be introduced via a femoral artery to a coronary ostium.
- 28. The catheter system of claim 26, wherein the perfusion catheter further comprises a tubular portion, the tubular portion adapted to provide at least one of (i) a sufficient internal diameter to allow a flow rate of about 150-250 ml/min or greater for processed blood or (ii) coronary perfusion pressure of about 100-150 mmHg.
- 29. The catheter system of claim 26, wherein a distal end of the perfusion catheter comprises a pre-shaped curvature adapted to allow engagement of the distal end of the perfusion catheter into a coronary artery ostium.
- 30. The catheter system of claim 29, wherein the pre-shaped curvature is adapted to be compatible with an aortic root.
- 31. The catheter system of claim 26, wherein the catheter system further comprises an arterial sheath adapted to received at least one of (i) the collecting catheter or (ii) the perfusion catheter.
- 32. The catheter system of claim 31, wherein a length of the arterial sheath is sufficient to allow a catheter disposed within the arterial sheath to be introduced via a femoral artery to an aortic root.
- 33. The catheter system of claim 31, further comprising a vehicle catheter adapted to pass through the arterial sheath.
- 34. The catheter system of claim 33, wherein the vehicle catheter further comprises a pressure channel adapted to monitor blood pressure within the ascending aorta.
- 35. The catheter system of claim 33, wherein the perfusion catheter comprises a plurality of perfusion catheters contained at least partially within the vehicle catheter.
- 36. The catheter system of claim 26, wherein each of the collecting catheter and the perfusion catheter further comprise an inflatable balloon disposed proximate a distal end.
- 37. The catheter system of claim 36, wherein the inflatable balloon is adapted to at least one of (i) substantially completely block a coronary ostium to isolate the coronary system from systemic circulation or (ii) are adapted to not completely block the coronary ostium.
- 38. The catheter system of claim 37, wherein, upon inflation, the inflatable balloon adapted to not completely block the coronary ostium comprises at least one of (i) a ring shape or (ii) a butterfly shape.
- 39. The catheter system of claim 26, wherein the perfusing collecting catheter further comprises:
a. a changeable curvature; and b. a changeable tip angulation.
- 40. The catheter system of claim 39, wherein curvature and tip angulation may be changed implementing fibers along the length of the catheter to facilitate coronary engagement.
- 41. The catheter system of claim 26, wherein:
a. the collecting catheter is adapted to be engaged in the coronary sinus ostium to collect venous blood from the patient; and b. the perfusion catheter is adapted to be engaged into the coronary artery ostia of the patient to deliver blood to the patient.
- 42. The catheter system of claim 26, wherein the perfusion catheter further comprises a sensor.
- 43. The catheter system of claim 42, wherein the sensor comprises:
a. a temperature sensor disposed proximate a wall of the tubular component; and b. a pressure sensor disposed proximate the wall of the tubular component.
- 44. The catheter system of claim 26, wherein the perfusion catheter further comprises an inflation channel disposed proximate a wall of the tubular component.
- 45. A method of coronary analysis, comprising:
a. obtaining access to a coronary access site in a patient via a predetermined entry site of the patient; b. introducing an arterial sheath via the entry site; c. introducing a collecting catheter into a first coronary artery via the arterial sheath to the entry site; d. introducing a perfusion catheter into a second coronary artery via the arterial sheath to the entry site; e. engaging a distal end of the perfusion catheter at an engaging site, the distal end of the perfrusion catheter comprising a pre-shaped curvature to facilitate engagement of the perfusion catheter at the entry site; f. connecting the collecting catheter to an input of a multi-chambered dialysis machine; g. connecting the perfusion catheter to an output of the multi-chambered dialysis machine; h. collecting venous blood using the collecting catheter; i. introducing the collected blood into a first chamber of the multi-chambered multi-chambered dialysis machine; j. performing a first processing on the blood in the first chamber; k. introducing processed blood from the first chamber into a second chamber of the multi-chambered multi-chambered dialysis machine; l. performing a second processing on the blood in the second chamber; and m. returning processed blood to the patient via the perfusion catheter.
- 46. The method of claim 45, wherein the arterial sheath is introduced using Seldinger's method.
- 47. The method of claim 45, wherein the entry site is at least one of (i) a femoral artery, (ii) a left subclavian vein to engage into the coronary sinus, (iii) a right subclavian vein into right atrium, (iv) a right jugular vein directly into right atrium, or (v) a femoral vein.
- 48. The method of claim 45, further comprising configuring the first chamber as a blood separation chamber for separating blood plasma and a harmful substance from the blood, the blood separation chamber adapted to provide at least one of (i) a plasmapheresis function or (ii) an aphaeresis function.
- 49. The method of claim 48, wherein the harmful substance comprises at least one of (i) LDL, (ii) fibrinogen, (iii) C reactive protein, (iv) cytokines, (v) cholesterol, (vi) triglyceride, (vii) perfused HDL, (viii) Lp (a), (ix) tissue factor, (x) interleukine, (xi) interleukine 1, (xii) interleukine 6, (xiii) TNF alpha, (xiv) a chemoattractant molecule, (xv) CD 14, (xvi) C3 complement, (xvii) C4 complement, or (xviii) C 1 inhibitor
- 50. The method of claim 45, wherein the second chamber is adapted to at least one of (i) deliver a drug into the blood, (ii) deliver a therapeutic component into the blood, (iii) maintain blood oxygenation at a desired level, (iv) sustain a desired coronary perfusion pressure, (v) or increase blood temperature to a desired level.
- 51. The method of claim 50, wherein the drug is a high level of drug.
- 52. The method of claim 50, wherein the therapeutic component is delivered continuously to the patient.
- 53. The method of claim 50, wherein the therapeutic component is at least one of (i) HDL, (ii) a statin, (iii) a gene, (iv) a chelating agent, (v) an anti-inflammatory agent, (vi) an angiotensin converting enzyme inhibitor, (vii) a peroxisome proliferator activated receptor agonist, (viii) apolipoprotein apoA1, (ix) mutated apolipoprotein apoA1, or (x) a gene for gene therapy.
- 54. The method of claim 45, further comprising providing a flow rate of at least around 150 ml/min for processed blood.
- 55. The method of claim 54, wherein the flow rate is between around 150 ml/min and around 250 ml/min for processed blood.
- 56. The method of claim 45, wherein the engaging site is at least one of (i) a coronary artery ostium or (ii) a coronary sinus ostium.
- 57. The method of claim 45, wherein an outcome of the return of processed blood is at least one of (i) stabilizing a vulnerable plaque, (ii) decreasing the lipid content of the vulnerable plaque, (iii) reducing inflammatory activity throughout the coronary system, (iv) decreasing the number of macrophages in the vulnerable plaque, or (v) increasing the number of smooth muscle cells in the vulnerable plaque.
- 58. The method of claim 45, wherein the patient has been diagnosed with at least one of (i) atherosclerosis, (ii) chronic coronary artery disease, (iii) acute coronary syndrome, (iv) unstable angina, or (v) acute myocardial infarction.
- 59. The method of claim 45, further comprising:
a. providing a vehicle catheter, the vehicle catheter comprising a substantially tubular portion and a preformed curvature at its distal end, the curvature being compatible with an aortic arch; and b. introducing the vehicle catheter via the arterial sheath to the ascending aorta above a coronary ostium.
- 60. The method of claim 59, further comprising:
a. providing the vehicle catheter with an inflatable aortic root ring; b. providing a fluid pathway from an inflator to the inflatable aortic root ring; and c. inflating the inflatable aortic root ring after a perfusion dialysis catheter contained within the vehicle catheter is engaged into the coronary ostium.
- 61. The method of claim 45, further comprising:
a. providing an annulus proximate a distal tip of the perfusing catheter; b. connecting the distal tip of the perfusing catheter to a vacuum source; and c. generating a negative pressure at the annulus upon engaging the distal tip of the perfusing catheter into the coronary ostium, the pressure being sufficient to facilitate attachment and fixation of the perfusion catheter in the coronary ostium.
- 62. The method of claim 61, wherein the negative pressure is generated when the distal tip of the perfusing catheter is approximately 2 to 3 cm into the coronary ostium.
- 63. The method of claim 45, further comprising using the coronary dialysis system to increase a level of useful factors in the plasma, the useful factors beneficial for promoting at least one of (i) plaque stabilization or (ii) plaque regression.
- 64. The method of claim 45, wherein:
a. the collecting catheter further comprises an inflatable balloon disposed proximate a distal end of the collecting catheter; and b. a coronary ostium is occluded by inflating the inflatable balloon to substantially completely isolate the coronary arteries from systemic circulation in order to prevent dilution of processed blood by the systemic blood.
- 65. The method of claim 64, wherein the second chamber further comprises:
a. an oxygenator; and b. a pump.
- 66. The method of claim 64, further comprising maintaining a coronary perfusion pressure of between around 100 mm Hg to around 150 mmHg where the coronary artery is completely isolated from blood flow.
- 67. A method of coronary dialysis, comprising:
a. providing a coronary dialysis system comprising a catheter system and a multi-chamber dialysis machine, the coronary dialysis system forming a pathway for a patient's blood; b. collecting the blood; c. draining the blood through an inlet of the multi-chamber dialysis machine; d. passing the blood through a plurality of processing chambers in the multi-chamber dialysis machine; e. processing the blood within the plurality of processing chambers to at least one of (i) remove a harmful substance in the blood or (ii) add an enriching substance to the blood; and f. pumping the processed blood back to the patient's coronary circulation through an outlet of the dialysis machine via a perfusion catheter component of the catheter system.
- 68. The method of claim 67, wherein processing further comprises at least one of (i) filtering a substance from the blood or (ii) precipitating a substance from the blood.
- 69. The method of claim 67, wherein:
a. the enriching substance comprises a predetermined level of a therapeutic agent; and b. the therapeutic agent is maintained in an intimate vicinity of coronary endothelial cells by preventing dilution of processed blood by the systemic circulation.
- 70. The method of claim 67, further comprising:
a. providing an annulus in the perfusing catheter proximate the distal tip of the perfusing catheter; b. operatively connecting the distal tip to a vacuum source; and c. generating a negative pressure at the annulus upon engaging the distal tip into the coronary ostium, the negative pressure being sufficient to facilitate attachment and fixation of the perfusion catheter in the coronary ostium.
- 71. The method of claim 70, wherein the negative pressure is generated when the distal tip is approximately 2 to 3 cm into the coronary ostium.
- 72. The method of claim 67, wherein:
a. the coronary system of the patient is not completely isolated with respect to blood flow; and b. the multi-chambered dialysis machine comprises a blood separation chamber, an enricher, a heater, and a pump.
- 73. The method of claim 72, wherein the blood separation chamber further comprises at least one of (i) a plasmaphaeresis chamber or (ii) an aphaeresis chamber.
- 74. The method of claim 73, wherein:
a. the plasmaphaeresis chamber is in fluid communication with the inlet; b. the aphaeresis chamber is in fluid communication with the plasmapharaersis chamber following the plasmapharaersis chamber; c. the heater is in fluid communication with the aphaeresis chamber following the aphaeresis chamber; d. the enricher is in fluid communication with the heater following the heating chamber; and e. the pump is in fluid communication with the enricher following the enricher and the outlet.
- 75. The method of claim 67, wherein:
a. the collecting catheter further comprises an inflatable balloon disposed proximate a distal end of the collecting catheter; and b. a coronary ostium is not completely occluded by the inflatable balloon; c. whereby the coronary arteries are not substantially isolated from systemic circulation.
- 76. The method of claim 72, further comprising:
a. separating blood cells from blood plasma in the blood separation chamber; b. separating a predetermined substance from the blood plasma in the blood separation chamber; c. enriching the blood in the enricher with a therapeutic agent; d. heating the blood to an appropriate level with the heater; and e. pumping processed blood with the pump at a desired flow rate and blood pressure.
- 77. The method of claim 76, wherein the predetermined substance separated from the plasma in the blood separation chamber comprises at least one of (i) LDL, (ii) extra HDL, (iii) CRP, (iv) fibrinogen, (v) a plasma cytokine, (vi) a chelating agent, or (vii) a transgenic material.
- 78. The method of claim 76, wherein the predetermined substance separated from the plasma in the blood separation chamber is separated by at least one of (i) precipitation, (ii) filtration, or (iii) adsorption.
- 79. The method of claim 76, wherein therapeutic agent comprises at east one of (i) HDL, (ii) a chelating agent, (iii) a transgene, or (iv) a drug.
- 80. A method of blood dialysis, comprising:
a. providing a dialysis system comprising a catheter system and a multi-chamber dialysis machine, the dialysis system forming a pathway for a patient's blood; b. collecting the blood from a non-coronary drain site; c. draining the blood through an inlet of the multi-chamber dialysis machine; d. passing the blood through a plurality of processing chambers in the multi-chamber dialysis machine; e. processing the blood within the plurality of processing chambers to at least one of (i) remove a harmful substance in the blood or (ii) add an enriching substance to the blood; and f. pumping the processed blood back to the patient's coronary circulation through an outlet of the dialysis machine via a perfusion catheter component of the catheter system into a non-coronary return site.
- 81. The method of claim 80, wherein the non-coronary drain site comprises a femoral artery and the non-coronary return site comprises a femoral vein.
- 82. The method of claim 80, wherein processing further comprises at least one of (i) filtering a substance from the blood or (ii) precipitating a substance from the blood.
- 83. The method of claim 80, wherein the enriching substance comprises a predetermined level of a therapeutic agent.
- 84. The method of claim 80, wherein the dialysis system multi-chambered dialysis machine comprises a blood separation chamber, an enricher, a heater, and a pump.
- 85. The method of claim 84, further comprising:
a. separating blood cells from blood plasma in the blood separation chamber; b. separating a predetermined substance from the blood plasma in the blood separation chamber; c. enriching the blood in the enricher with a therapeutic agent; d. heating the blood to an desired level with the heater; and e. pumping processed blood in the pump at a desired flow rate and blood pressure.
- 86. The method of claim 85, wherein the predetermined substance separated from the plasma in the blood separation chamber comprises at least one of (i) LDL, (ii) extra HDL, (iii) CRP, (iv) fibrinogen, (v) a plasma cytokine, (vi) a chelating agent, or (vii) a transgenic material.
- 87. The method of claim 85, wherein the predetermined substance separated from the plasma in the blood separation chamber is separated by at least one of (i) precipitation, (ii) filtration, or (iii) adsorption.
- 88. The method of claim 85, wherein therapeutic agent comprises at east one of (i) HDL, (ii) a chelating agent, (iii) a transgene, or (iv) a drug.
- 89. The method of claim 84, wherein the blood separation chamber further comprises at least one of (i) a plasmaphaeresis chamber or (ii) an aphaeresis chamber.
- 90. The method of claim 89, wherein:
a. the plasmaphaeresis chamber is in fluid communication with the inlet; b. the aphaeresis chamber is in fluid communication with the plasmapharaersis chamber following the plasmapharaersis chamber; c. the heater is in fluid communication with the blood separation chamber following the blood separation chamber; d. the enricher is in fluid communication with the heater following the heater; and e. the pump is in fluid communication with the enricher following the enricher and the outlet. Fourth General Method: Pericardial Dialysis
- 91. A method of fluid dialysis, comprising:
a. providing a dialysis system comprising a catheter system and a multi-chamber dialysis machine, the dialysis system forming a pathway for a patient's blood; b. introducing a collection catheter into a pericardium of a patient; c. collecting fluid from within the pericardium; d. draining the fluid through an inlet of the multi-chamber dialysis machine; e. passing the fluid through a plurality of processing chambers in the multi-chamber dialysis machine; f. processing the fluid within the plurality of processing chambers to at least one of (i) remove at least one harmful substance in the fluid or (ii) add at least one enriching substance to the fluid; and g. pumping the processed fluid back to the pericardium through an outlet of the dialysis machine via a perfusion catheter component of the catheter system into the pericardium.
- 92. The method of claim 91, wherein processing further comprises at least one of (i) filtering a substance from the fluid or (ii) precipitating a substance from the fluid.
- 93. The method of claim 91, wherein the enriching substance comprises a predetermined level of a therapeutic agent.
- 94. The method of claim 91, wherein the dialysis system multi-chambered dialysis machine comprises a fluid component separation chamber, an enricher, a heater, and a pump.
- 95. The method of claim 94, further comprising:
a. separating a predetermined substance from the fluid in the fluid component separation chamber; b. enriching the fluid in the enricher with a therapeutic agent; c. heating the fluid to an desired level with the heater; and d. pumping processed fluid in the pump at a desired flow rate and pressure.
RELATION TO PRIOR APPLICATIONS
[0001] The present invention claims priority through U.S. Provisional Application No. 60/389,834, filed Jun. 19, 2002.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60389834 |
Jun 2002 |
US |