Autologous blood recovery membrane system and method

• US 5,055,198 A
• Filed: 05/18/1990
• Issued: 10/08/1991
• Est. Priority Date: 03/07/1990
• Status: Expired due to Fees

• Current Assignee: Asahi Medical Co. Ltd. (Asahi Kasei Corporation)
• Original Assignee: Shettigar U. Ramakrishna
• Inventors: Shettigar, U. Ramakrishna
• Primary Examiner(s): Jones, W. Gary
• Application Number:
  US07/525,536
• Time in Patent Office: 508 Days
• Field of Search: 210/650, 210/744, 210/806, 210/86, 210/97, 210/104, 210/136, 210/257.2, 210/258, 210/259, 210/295, 210/299, 210/314, 210/321.6, 210/321.82-321.9, 210/772 , 210/805, 210/808, 210/406, 210/416.1, 210/472, 604/4, 604/5, 604/6, 604/28, 604/35, 604/36, 604/317, 604/318, 604/319, 604/320, 604/321, 604/404, 604/406
• US Class Current: 210/650
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3604 in opposite directions
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/3616 Batch-type treatment
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 1/3675 Deactivation
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/631 Emptying the suction container without interrupting suction
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3382 Upper level detectors
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence

Abstract

An apparatus for recycling autologous blood from a patient for reinfusion back to the patient comprising suction means, admixing means for admixing aspirated blood with a washing fluid, filtering means for filtering the admixture through an emboli filter and a membrane filter, monitoring means for measuring the amount of cellular component volume in the filtered blood, filtration means for removing excess fluid and particulates from the blood, and reinfusion means is disclosed. Embodiments for use during surgery for on-line purification and reinfusion on a real time basis are disclosed along with embodiments for use post-surgically when the wound site is closed and drainage tubing has been implanted at the wound site to draw off blood post-surgically. Methods for performing the autotransfusion process are also disclosed.

Claims

1. An apparatus for filtering autologous blood taken from a patient for reinfusion to the patient comprising:

suction means for aspirating blood from a wound site;

first conduit means for conducting said aspirated blood from said suction means;

washing fluid retainer means for retaining washing fluid for admixing with said aspirated blood;

second conduit means interconnected between said washing fluid retainer means and said first conduit for conducting washing fluid therebetween;

first filter means for removing emboli and large particulates from said aspirated blood, said first filter means being connected to said first conduit means;

filter casing means for enclosing said first filter means therein, said filter casing having vacuum connector means associated therewith for attaching a source of vacuum;

reservoir means associated with said filter casing means for collecting filtered blood from said first filter means;

second filter means for filtering excess fluids and impurities from said blood;

third conduit means interconnected between said reservoir means and said second filter means for conducting blood therebetween;

blood collection means for collecting filtered blood;

fourth conduit means interconnected between said second filter and said blood collection means for conducting filtered blood therebetween;

filtrate container means for containing said excess fluids and impurities filtered from said blood by said second filter means;

fifth conduit means interconnected between said second filter means and said filtrate container means for conducting filtrate therethrough; and

reinfusion means associated with said blood collection means for reinfusing purified blood to the patient.

2. The apparatus of claim 1 wherein said washing fluid retainer means is positioned below said suction means.

3. The apparatus of claim 2 wherein said first filter means is positioned from about two feet to about five feet above the relative height of said suction means.

4. The apparatus of claim 3 wherein said first filter means is positioned relative to said second filter means to enable movement of blood to the latter by gravity.

5. The apparatus of claim 4 wherein said blood collection means is positioned at a height above the relative height of said second filter means.

6. The apparatus of claim 5 wherein said filtrate container means has vacuum connector means associated therewith.

7. The apparatus of claim 6 further comprising adjustable clamp means associated with said first conduit for closing off said first conduit.

8. The apparatus of claim 6 wherein said blood collection means comprises a plurality of non-collapsible containers, each container having associated therewith a vacuum connector means for attaching a source of vacuum.

9. The apparatus of claim 8 wherein said fourth conduit is divided into separate branches, each said separate branch of said fourth conduit being attachable to a said non-collapsible container.

10. The apparatus of claim 9 further comprising vacuum line means associated with each said vacuum connector means of each said non-collapsible container and further associated with said vacuum connector means of said filter casing, said vacuum line being attachable to a vacuum source.

11. The apparatus of claim 10 further comprising vacuum control means associated with said vacuum line to control the amount of pressure applied to each said non-collapsible container by the vacuum source.

12. The apparatus of claim 11 further comprising filter means attached to said vacuum line associated with each said non-collapsible container for filtering and preventing unwanted particles from entering said non-collapsible containers through said vacuum line.

13. The apparatus of claim 12 wherein said vacuum line is also connected to said vacuum connector means of said filtrate container.

14. The apparatus of claim 13 further comprising air venting means for venting off entrapped air bubbles from the blood, said air venting means being interconnected between said third conduit and said filter casing means.

15. The apparatus of claim 14 further comprising auxiliary blood collection means connected to said third conduit means for collecting blood therein, said auxiliary blood collection means having port means for conducting fluids therethrough.

16. The apparatus of claim 5 further comprising first blood level detector means associated with said blood collection means for detecting the level of blood in said blood collection means.

17. The apparatus of claim 16 further comprising second blood component level detector means associated with said reinfusion means for measuring the level of blood components in said blood prior to reinfusion.

18. The apparatus of claim 17 further comprising anticoagulant neutralizer container means connected to said reinfusion means for retaining anticoagulant neutralizer.

19. The apparatus of claim 18 further comprising first pump means connected to said reinfusion means for pumping blood from said blood collection means to said patient.

20. The apparatus of claim 19 further comprising second pump means connected to said fifth conduit for urging said filtrate from said second filter means.

21. The apparatus of claim 20 further comprising control means in electro-mechanical communication with said adjustable clamp means associated with said first conduit means for actuating said clamp means.

22. The apparatus of claim 1 wherein said first filter further comprises porous material having a pore size of about 40 microns and having an upper end and a lower end, said lower end being covered with hydrophilic fabric and said upper end being covered with hydrophobic fabric, and said porous material being contacted with an antifoam agent.

23. The apparatus of claim 1 wherein said second filter comprises a porous membrane having a pore size from about 40,000 daltons to about 0.4 microns.

24. The apparatus of claim 23 wherein said pore size of said porous membrane is about 100,000 daltons.

25. The apparatus of claim 1 wherein said suction means further comprises:

handle means for grasping;

first duct means for passage of blood therethrough, said first duct means having a first end defining a tip and a second end for connection to said first conduit means;

second duct means for passage of washing fluid therethrough, said second duct having a first opening in communication with said second conduit means and a second opening in communication with said first duct means such that said first duct means and said second duct means are substantially parallel and the movement of said blood through said fist duct means and the movement of said washing fluid in said second duct means is in the same direction.

26. An apparatus for filtering autologous blood taken from a patient for reinfusion to the patient comprising:

suction means for aspirating blood from a wound site;

first conduit means for conducting said aspirated blood from said suction means;

first filter means for removing emboli and large particulates from said aspirated blood, said first filter means being connected to said first conduit means;

filter casing means for enclosing said first filter means therein, said filter casing having vacuum connector means associated therewith for attaching a source of vacuum;

reservoir means associated with said filter casing means for collecting filtered blood from said first filter means;

second filter means for filtering excess fluids and impurities from said blood;

second conduit means interconnected between said reservoir means and said second filter means for conducting blood therebetween;

blood collection means for collecting filtered blood;

third conduit means interconnected between said second filter and said blood collection means for conducting filtered blood therebetween;

filtrate container means for containing said excess fluids and impurities filtered from said blood by said second filter means;

fourth conduit means interconnected between said second filter means and said filtrate container means for conducting filtrate therethrough;

first adjustable clamp means associated with said fourth conduit means for preventing flow of filtrate therethrough; and

reinfusion means associated with said blood collection means for reinfusing purified blood to the patient.

27. The apparatus of claim 26 wherein said third conduit further comprises separate branches, each branch having connector means for attaching blood collection means thereto.

28. The apparatus of claim 27 wherein each said blood collection means has a port means for passage of fluids therethrough.

29. The apparatus of claim 26 further comprising auxiliary blood retainer means connected to said second conduit means for retaining blood conducted through said second conduit from said reservoir, and further comprising second adjustable clamp means associated with said second conduit means between said auxiliary blood retainer means and said second filter means for preventing fluid from passing therebetween.

30. The apparatus of claim 29 wherein said auxiliary blood retainer means has port means for passage of fluid therethrough.

31. The apparatus of claim 30 wherein said blood collection means contains washing fluid therein for mixing with said aspirated blood.

32. The apparatus of claim 31 wherein said suction means is positioned from about two feet to about five feet below the relative height of said first filter means, wherein said first filter means is at least six feet in height above said second filter means, and wherein said second conduit means is at least six feet in length.

33. The apparatus of claim 32 further comprising vacuum regulator means in communication with said first filter means for regulating the amount of negative pressure applied thereto.

34. The apparatus of claim 33 wherein said vacuum regulator means is a water manometer.

35. The apparatus of claim 34 further comprising bifurcated vacuum line means for attachment to a vacuum source, one end of said bifurcated vacuum line means being connected to said vacuum connector means of said filter casing means and the other end of said bifurcated vacuum line means being attached to said water manometer.

36. The apparatus of claim 35 wherein said bifurcated vacuum line has first valve means connected thereto, in proximity to said filter casing means, for preventing flow of liquid into said vacuum line means, and further comprising vacuum monitor means associated with said bifurcated vacuum line means for monitoring the pressure supplied by said vacuum source.

37. The apparatus of claim 36 further comprising valve means attached to said first conduit means for preventing backflow of matter therethrough.

38. The apparatus of claim 37 further comprising third adjustable clamp means connected to said second conduit means between said first filter means and said auxiliary blood retainer means for preventing passage of blood therethrough.

39. The apparatus of claim 33 wherein said vacuum regulator means is a piston-type regulator.

40. The apparatus of claim 32 further comprising vacuum connector means associated with said filtrate container means for attachment of a source of vacuum.

41. The apparatus of claim 26 wherein said first filter further comprises porous material having a pore size of about 40 microns and having an upper end and a lower end, said lower end being covered with hydrophilic fabric and said upper end being covered with hydrophilic fabric, and said porous material being contacted with an antifoam agent.

42. The apparatus of claim 26 wherein said second filter comprises a porous membrane having a pore size from about 40,000 daltons to about 0.4 microns.

43. The apparatus of claim 42 wherein said pore size of said porous membrane is about 100,000 daltons.

44. An apparatus for filtering autologous blood taken from a patient for reinfusion to the patient comprising:

suction means for aspirating blood from a wound site;

first conduit means for conducting said aspirated blood from said suction means;

washing fluid retainer means for retaining washing fluid for admixing with said aspirated blood;

second conduit means interconnected between said washing fluid retainer means and said first conduit for conducting washing fluid therebetween;

first filter means for removing emboli and large particulates from said aspirated blood, said first filter means being connected to said first conduit means;

filter casing means for enclosing said first filter means therein, said filter casing having vacuum connector means associated therewith for attaching a source of vacuum;

reservoir means associated with said filter casing means for collecting filtered blood from said first filter means;

second filter means for filtering excess fluids and impurities from said blood, said second filter being in communication with said filter casing means;

filtrate container means for containing said excess fluids and impurities filtered from said blood by said second filter means;

third conduit means interconnected between said second filter means and said filtrate container means for conducting filtrate therethrough; and

fourth conduit means in communication with said reservoir means for conducting filtered blood therethrough for reinfusion.

45. The apparatus of claim 44 wherein said first filter means and said second filter means are conjoined into said filter casing means, and further comprising vacuum connector means associated with said filter casing means for attaching a source of vacuum.

46. The apparatus of claim 45 further comprising first pump means associated with said third conduit means for urging said filtrate therethrough, second pump means associated with said fourth conduit means for urging filtered blood therethrough, and blood level detector means connected to said reservoir means for detecting the level of blood therein.

47. The apparatus of claim 46 further comprising blood component detector means connected to said fourth conduit means for detecting blood component levels in blood passing therethrough.

48. The apparatus of claim 46 further comprising third pump means associated with said second conduit for urging washing fluid therethrough.

49. The apparatus of claim 48 wherein said first pump means, said second pump means, and said third pump means are in electromechanical communication with each other.

50. The apparatus of claim 49 further comprising vent pump means associated with said filter casing means for venting air from said filter casing means and first filter means, and further comprising pressure regulator means connected to said filter casing means for regulating pressure thereto.

51. The apparatus of claim 44 further comprising fifth conduit means interconnected between said reservoir means and said second filter means for conducting blood therebetween, and further comprising recirculation pump means associated with said fifth conduit for urging blood therethrough.

52. The apparatus of claim 51 further comprising sixth conduit means interconnected between said second filter means and said reservoir means for conducting blood therethrough, said sixth conduit means being in communication with said fourth conduit means.

53. The apparatus of claim 52 further comprising blood level detector means associated with said reservoir means for measuring high and low levels of blood in said reservoir means.

54. The apparatus of claim 53 further comprising flow constriction means associated with said second filter means for providing transmembrane pressure in said second filter.

55. The apparatus of claim 54 further comprising blood component level detector means connected to said sixth conduit means for measuring the level of blood components in said blood.

56. The apparatus of claim 55 further comprising first valve means connected to said fourth conduit means and said sixth conduit means for alternately directing blood through said sixth conduit means and said fourth conduit means.

57. The apparatus of claim 56 further comprising second valve means connected to said third conduit means for opening and closing said conduit means.

58. The apparatus of claim 57 wherein said first valve means, said second valve means, said recirculation pump means and said blood component level detector means are in electromechanical communication with each other.

59. The apparatus of claim 58 further comprising third filter means connected to said fourth conduit means for filtering emboli and residual impurities from the blood prior to infusion, said filter having blood level detector means connected thereto for measuring the level of blood in said third filter means, and further comprising third valve means connected to said fourth conduit means for closing said fourth conduit, said third valve means being in electromechanical communication with said blood level detector means of said third filter means, said blood level detector means of said reservoir means, and said blood component level detector means.

60. The apparatus of claim 44 wherein said suction means further comprises:

handle means for grasping;

first duct means for passage of blood therethrough, said first duct means having a first end defining a tip and a second end for connection to said first conduit means;

second duct means for passage of washing fluid therethrough, said second duct having a first opening in communication with said second conduit means and a second opening in communication with said first duct means such that said first duct means and said second duct means are substantially parallel and the movement of said blood through said fist duct means and the movement of said washing fluid in said second duct means is in the same direction.

61. A method of recycling autologous blood for reinfusion into a patient comprising:

aspirating an amount of blood from a wound site under vacuum pressure;

admixing said blood with an amount of washing fluid approximately proportional to that of said blood;

introducing said admixture of approximately proportional amounts of blood and washing fluid into a first emboli filter under vacuum pressure;

filtering said admixture of blood and washing fluid through said emboli filter to remove air and large particles;

filtering said admixture through a membrane filter to remove impurities and excess fluid; and

reinfusing said filtered blood into said patient.

62. The method according to claim 61 further comprising monitoring said blood for volume of cellular components in said blood after filtering said blood through said membrane filter.

63. The method according to claim 62 further comprising recirculating said blood through said membrane filter and said emboli filter prior to reinfusing said blood into said patient until a desired amount of excess fluid and impurities have been removed, and a desired volume of blood cellular components remain in said blood.

64. The method according to claim 63 further comprising filtering said blood through a second emboli filter prior to reinfusing said blood into said patient to remove any air emboli and impurities therefrom.