Low trauma blood recovery system

• US 5,411,472 A
• Filed: 07/30/1992
• Issued: 05/02/1995
• Est. Priority Date: 07/30/1992
• Status: Expired due to Fees

• Current Assignee: Galen Medical Incorporated
• Original Assignee: Galen Medical Incorporated
• Inventors: Peterson, Dean M., Cusi, Dante S., Steg, Robert F. Jr.
• Primary Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US07/922,566
• Time in Patent Office: 1,006 Days
• Field of Search: 604/4, 604/5, 604/6, 604/257, 604/258, 604/266, 604/269, 604/902, 433/81, 433/91, 433/95, 433/96
• US Class Current: 604/6.11
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• 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 1/63 with means for emptying the suction container, e.g. by interrupting suction
• CPC Class Codes: A61M 1/631 Emptying the suction container without interrupting suction
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 60/109 incorporated within extracorporeal blood circuits or systems
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/36 for specific blood treatment; for specific therapy
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/562 for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
• CPC Class Codes: Y10S 604/902 Suction wands

Abstract

Recovery of blood from a wound site (12) during a surgical procedure is accomplished with low blood trauma that enables collection of increased amounts of blood having relatively little structural damage for return to the surgical patient. Blood trauma is decreased by accelerating liquid blood from the wound site to flow at a relatively low velocity with a relatively high negative gauge pressure and accelerating a mixture of blood and foam from the wound site to flow at a relatively high velocity and a relatively low negative gauge pressure. A suction wand is provided in which liquid blood (32) is separated from a mixture of blood and foam (16) at the wound site through the transport of the two separated fluids at the different velocities and negative gauge pressures. The wand includes an outer blood foam tube within which are three resiliently compressed, side-by-side tubes for handling liquid blood, rinse solution and anticoagulant. Low fluidic capacitance filter defoamer modules, having built-in diaphragm operated pumps, receive and filter recovered liquid blood and foam blood for transfer to separate storage bags.

Claims

1. A low trauma blood recovery system comprising:

first and second conduits having open ends attached to one another and that terminate closely adjacent to one another and are configured and arranged to be placed at a wound site with both said closely adjacent open ends at the wound site and open to the wound site,

first means for applying a discrete negative gauge pressure to said first conduit to cause blood to flow through the end of said first conduit at a low velocity, and

second means for applying a discrete negative gauge pressure to said second conduit to cause flow through the end of said second conduit at a velocity greater than said low velocity.

2. The system of claim 1 wherein said first means comprises means for applying a relatively high negative gauge pressure, low flow rate suction to said first conduit, and wherein said second means comprises means for applying a relatively low negative gauge pressure, high flow rate suction to said second conduit.

3. The apparatus of claim 1 wherein said first conduit lies within said second conduit.

4. The apparatus of claim 1 wherein said second conduit has an end portion adapted to be positioned at a wound site and wherein said first conduit is positioned within said second conduit and has an end portion that projects a small distance beyond the end portion of said second conduit.

5. The apparatus of claim 4 including a third conduit positioned within said second conduit, and means for selectively applying a liquid to said third conduit, said third conduit having an end portion adjacent the end portion of said second conduit.

6. The apparatus of claim 5 wherein said liquid is an anticoagulant.

7. The apparatus of claim 5 wherein said liquid is a wound rinse solution.

8. The apparatus of claim 1 including a wand housing, said first and second conduits being mounted in said wand housing, a signaling fluidic switch on said housing, and a signal conducting conduit coupled with said switch.

44. The system of claim 1 wherein said low velocity is not greater than about two meters per second.

45. The system of claim 44 wherein the velocity of flow through said second conduit is not greater than about 45 meters per second.

46. The system of claim 45 wherein said first mentioned negative gauge pressure is greater than the negative gauge pressure applied to said second conduit.

9. A low trauma blood recovery system comprising:

first and second conduits having closely adjacent ends configured and arranged to be placed at a wound site with both said ends at the wound site,

first means for applying a discrete negative gauge pressure to said first conduit to cause blood to flow through the first conduit at a low velocity,

second means for applying a discrete negative gauge pressure to said second conduit to cause flow through said second conduit at a velocity greater than said low velocity, and

a third conduit integrally formed with and extending along said first conduit, said first and third conduits being formed of a resilient material and positioned in a compressed side-by-side relation within said second conduit, the maximum dimension across the total width of said side-by-side first and third conduits in uncompressed relation being greater than the internal diameter of said second conduit, whereby said first and third conduits are resiliently positioned and compressed within said second conduit.

10. A blood recovery system comprising:

first and second closely adjacent wand conduits having end portions adapted to be placed at a wound site,

first and second defoamer modules,

first and second connecting conduits independently connecting said first and second wand conduits with said first and second modules, respectively, and

means for independently applying negative gauge pressure to each said module, thereby to provide mutually independent negative gauge pressures to said first and second conduits.

11. The recovery system of claim 10 including first and second blood pump means independently connected to said first and second modules respectively for extracting blood from said modules.

12. The apparatus of claim 11 wherein at least one of said blood pump means comprises a housing, a flexible membrane fixed to and extending across said housing and dividing said housing into first and second chambers, means for applying a pulsating vacuum to said first chamber, a blood inlet valve in said second chamber connected with the interior of one of said modules, and a blood output valve in said second chamber.

13. The apparatus of claim 12 wherein said blood pump means are built into said filter module.

14. The apparatus of claim 10 wherein said first conduit comprises a liquid blood conduit and wherein said means for independently applying negative gauge pressure comprises means for applying to said first module a pressure from a negative gauge pressure source and controlling the source to provide low velocity flow through said liquid blood conduit with high negative gauge pressure.

15. The apparatus of claim 14 wherein said second conduit comprises a foam blood conduit and wherein said means for independently applying negative gauge pressure to said second module comprises means for applying pressure from a negative gauge pressure source and controlling the source to provide second velocity flow higher than said low velocity flow with a second negative gauge pressure lower than said high negative gauge pressure.

16. The apparatus of claim 10 wherein said means for independently applying negative gauge pressures to said modules comprises means for applying a negative gauge pressure to said first module to cause blood to flow through said liquid blood conduit at a relatively low velocity of not more than about two meters per second.

17. Blood recovery apparatus comprising:

a suction wand housing,

an outer foam blood mixture wand conduit secured to said wand housing having an end portion,

a plurality of mutually adjacent inner wand conduits within said outer wand conduit and including a liquid blood wand conduit having an end portion projecting slightly beyond the end portion of said outer conduit, and

a multi-conduit array having individual connecting conduits respectively connected to individual ones of said outer foam blood mixture wand conduit and each of adjacent inner wand conduits within said outer foam blood mixture wand conduit.

18. The apparatus of claim 17 wherein said array includes a foam blood connecting conduit and a liquid blood connecting conduit adjacent and external to said foam blood connecting conduit, said foam blood wand conduit having a crossover transition section connected with said foam blood connecting conduit, said liquid blood connecting conduit extending from a position adjacent said foam blood connecting conduit through said crossover transition section into said outer foam blood wand conduit for connection to said liquid blood wand conduit.

19. The apparatus of claim 17 including first and second filter modules, a first one of said connecting conduits being connected to and between said first module and said outer foam blood mixture wand conduit, a second one of said connecting conduits being connected to and between said second module and said liquid blood wand conduit, a system control module, means for connecting said system control module to a vacuum source, said system control module including a first vacuum controller means for applying a regulated negative gauge pressure to said second filter module to flow liquid blood through said liquid blood wand conduit at a relatively low velocity with a relatively high negative gauge pressure, a second vacuum controller means in said system control module for applying to said first filter module a negative gauge pressure to cause a foam blood mixture to flow through said outer foam blood mixture wand conduit at a relatively high velocity with a relatively low negative gauge pressure.

20. The apparatus of claim 19 including a source of rinse, a source of anticoagulant, said connecting conduits including a rinse connecting conduit and an anticoagulant connecting conduit, said inner wand conduits including an anticoagulant wand conduit and a rinse wand conduit connected to said anticoagulant connecting conduit and to said rinse connecting conduit, respectively.

21. The apparatus of claim 17 including means for applying relatively high negative gauge pressure to one of said connecting conduits so as to cause liquid blood to flow through said liquid blood wand conduit at a velocity of not more than about 1 meter per second, and including means for applying relatively low negative gauge pressure to a second one of said connecting conduits to cause a foam blood mixture to flow through said foam blood mixture wand conduit at a velocity of not less than about 40 liters per second.

22. Blood collection apparatus comprising:

a housing,

a blood defoamer in said housing,

conduit means for introducing blood to be recovered into said housing,

vacuum means for applying a vacuum to said housing to draw blood through said defoamer into said housing,

a storage reservoir connected to the housing, and

pump means mounted to said housing means for transferring blood from said housing to said reservoir, said housing having a total internal volume of not more than two liters for allowing variations of pressure within said housing to be more rapidly responsive to variation of vacuum applied by said vacuum means.

23. The apparatus of claim 22 wherein said reservoir is separate from said housing.

24. The apparatus of claim 23 including means for detachably connecting said reservoir to said housing.

25. The apparatus of claim 23 wherein said reservoir comprises a flexible storage bag, and said means for transferring comprises an aseptic detachable connection.

26. Blood collection apparatus comprising:

a housing,

a blood defoamer and filter in said housing

means for introducing blood to be recovered into said filter,

vacuum means for applying a vacuum to said housing to draw blood through said filter into said housing,

a storage reservoirs, and

means for transferring blood from said housing to said reservoir, said means for transferring comprising a pump body, a flexible diaphragm mounted within said body and extending across the body to divide the body into separate pumping and pressure chambers, said housing having a blood outlet fitting, an inlet valve in said pumping chamber connected to said fitting, an outlet valve in said pumping chamber connected to said storage reservoir, and means for applying a pulsating pressure to said pressure chamber.

27. The apparatus of claim 26 wherein said means for applying a pulsating pressure to said pressure chamber comprises said vacuum means for applying negative gauge pressure to said pressure chamber, and means for varying the pressure applied from said vacuum means to said pressure chamber.

28. A cardiotomy reservoir comprising:

a housing having an output port,

a blood defoamer in the housing,

a blood input port in the housing for flowing blood into the defoamer,

a pump connected to the housing and having an input valve connected to said output port,

means for applying negative gauge pressure to said housing to draw blood into said defoamer, and

means for operating the pump to draw blood from said housing,

said housing having an internal volume of not more than two liters, to improve the response time of internal pressure in the reservoir to changes in negative gauge pressure applied to the housing.

29. A cardiotomy reservoir comprising:

a housing having an output port,

a blood defoamer and filter in the housing,

a blood input port in the housing for flowing blood into the defoamer and filter,

a pump fixed to the housing and having an input valve connected to said output port,

means for applying negative gauge pressure to said housing to draw blood into said defoamer and filter, and

means for operating the pump to draw blood from said housing, said pump comprising a pump housing having an outlet valve, a flexible diaphragm dividing the pump housing into pumping and pressure chambers, said input and outlet valves being in said pumping chamber, and means for applying a pulsating pressure to said diaphragm.

30. A low trauma blood recovery system comprising:

a wand housing,

first and second closely adjacent conduits mounted in said wand housing and having open end portions attached to one another and that terminate closely adjacent to each other adapted to be placed at a wound site to cause each conduit to be independently and directly open to said wound site,

first means for applying a discrete negative gauge pressure to said first conduit to cause blood to flow through the first conduit end portion at a low velocity,

second means independent of said first means for applying a discrete negative gauge pressure to said second conduit to cause flow through said second conduit end portion at a velocity independent of said low velocity and greater than said low velocity,

a signaling switch on said housing, and

signal conducting means connected to said switch and housing for conducting a signal to a location remote from said housing.

31. The system of claim 30 wherein said switch is a fluidic switch.

32. A blood recovery system comprising:

a housing,

a bail

first, second and third closely adjacent conduits mounted in said housing and having open ends in said bail and separately open directly to said wound site, said open ends of said first and second conduits terminating in said bail closely adjacent to one another and being attached to one another by said bail,

first means for applying a discrete negative gauge pressure to said first conduit to cause flow through the first conduit from a wound site,

second means independent of said first means for applying a discrete negative gauge pressure to said second conduit to cause flow through said second conduit from a wound site independent of said flow through said first conduit, and

means for causing flow through said third conduit toward said wound site.

33. Blood recovery apparatus comprising:

a suction wand housing,

an outer wand conduit connected to said housing and having an end portion,

a bail mounted to the end portion of said outer wand conduit,

a first inner wand conduit within said outer wand conduit, said outer wand conduit and said first inner wand conduit having mutually separate open ends mounted in said bail and attached to each other, said open ends terminating in said bail closely adjacent to one another and being configured and arranged to be positioned in mutual proximity within a wound site to enable fluid to be sucked from the wound site at both said open ends,

first and second connecting conduits connected respectively said outer and inner wand conduits, and

a transition section connecting said outer wand conduit with said first connecting conduit.

34. The apparatus of claim 33 wherein said outer wand conduit comprises a foam blood mixture wand conduit and said inner wand conduit comprises a liquid blood wand conduit, said foam blood mixture wand conduit having an end, and said liquid blood wand conduit having an end extending a small distance beyond the end of said foam blood mixture wand conduit.

35. Blood recovery apparatus comprising:

a suction wand housing,

an outer wand conduit connected to said housing,

a first inner wand conduit within said outer wand conduit, said outer wand conduit and said first inner wand conduit having mutually adjacent ends configured and arranged to be positioned in mutual proximity within a wound site to enable fluid to be sucked from the wound site at both said mutually adjacent ends,

first and second connecting conduits connected respectively said outer and inner wand conduits,

a transition section connecting said outer wand conduit with said first connecting conduit, and

a plurality of resilient inner wand conduits within said outer wand conduit, said first inner wand conduit comprising one of said resilient inner wand conduits, said resilient inner wand conduits being transversely compressed against each other and against inner walls of said outer wand conduit thereby resiliently and frictionally securing said inner wand conduits to and within said outer wand conduit.

36. The apparatus of claim 35 including a fluidic finger control switch on said housing, and a fluidic signal conduit connected to said switch.

37. Blood recovery apparatus comprising:

a suction wand housing,

an outer wand conduit connected to said housing,

a first inner wand conduit within said outer wand conduit,

first and second connecting conduits connected respectively said outer and inner wand conduits, and

a transition section connecting said outer wand conduit with said first connecting conduit,

a plurality of resilient inner wand conduits within said outer wand conduit, said first inner wand conduit comprising one of said resilient inner wand conduits, said resilient inner wand conduits being transversely compressed against each other and against inner walls of said outer wand conduit thereby resiliently and frictionally securing said inner wand conduits to and within said outer wand conduit, at least two of said inner resilient wand conduits being formed by a single integral extrusion.

38. Blood recovery apparatus comprising:

a suction wand housing,

an outer wand conduit connected to said housing,

an inner wand conduit within said outer wand conduit,

first and second connecting conduits connected respectively said outer and inner wand conduits,

a transition section connecting said outer wand conduit with said first connecting conduit, said outer wand conduit comprising a foam blood mixture wand conduit and said inner wand conduit comprising a liquid blood wand conduit, said foam blood mixture wand conduit having an end, and said liquid blood wand conduit having an end extending a small distance beyond the end of said foam blood mixture wand conduit, and

a bail fixed to said outer wand conduit and having a bail end, said foam blood mixture wand conduit terminating within said bail at a first distance from said bail end, said liquid blood wand conduit terminating within said bail at a second distance from said bail end that is smaller than said first mentioned distance.

39. Blood recovery apparatus comprising:

a suction wand housing,

an outer wand conduit connected to said housing,

a first inner wand conduit within said outer wand conduit,

first and second connecting conduits connected respectively said outer and inner wand conduits, and

a transition section connecting said outer wand conduit with said first connecting conduit,

a plurality of resilient inner wand conduits within said outer wand conduit, said first inner wand conduit comprising one of said resilient inner wand conduits, said resilient inner wand conduits being transversely compressed against each other and against inner walls of said outer wand conduit thereby resiliently and frictionally securing said inner wand conduits to and within said outer wand conduit, said outer wand conduit comprising a foam blood mixture wand conduit, said resilient inner wand conduits including a liquid blood wand conduit, a rinse wand conduit and an anticoagulant wand conduit, all compressed against one another within said outer wand conduit.

40. The apparatus of claim 39 wherein said liquid blood wand conduit, said rinse wand conduit and said anticoagulant wand conduit are all formed as a single integral multiple conduit extrusion.

41. The apparatus of claim 40 wherein said connecting conduits comprises a foam blood mixture connecting conduit, a liquid blood connecting conduit, a rinse connecting conduit, and an anticoagulant connecting conduit connecting with respective ones of said wand conduits and all formed of a single integral multiple conduit extrusion.

42. Blood recovery apparatus comprising:

a suction wand housing,

an outer wand conduit connected to said housing,

a first inner wand conduit within said outer wand conduit,

first and second connecting conduits connected respectively said outer and inner wand conduits, and

a transition section connecting said outer wand conduit with said first connecting conduit,

a plurality of resilient inner wand conduits within said outer wand conduit, said first inner wand conduit comprising one of said resilient inner wand conduits, said resilient inner wand conduits being transversely compressed against each other and against inner walls of said outer wand conduit thereby resiliently and frictionally securing said inner wand conduits to and within said outer wand conduit, all of said inner wand conduits being formed as an integral group of side-by-side extruded conduits.

43. The apparatus of claim 42 including means for applying a low velocity high negative pressure to the liquid blood wand conduit and means for applying high velocity low negative pressure to the foam blood mixture wand conduit.

47. Blood collection apparatus comprising:

a housing,

a blood defoamer and filter in said housing,

means for introducing blood to be recovered into said filter,

vacuum means for applying a vacuum to said housing to draw blood through said filter into said housing, said housing having a bottom interior surface that forms a relatively narrow inclined passage for flowing defoamed and filtered blood by gravity toward one end of the housing,

said housing having an internal volume of not more than two liters, to improve response time of said internal volume to changes in vacuum applied to said housing,

a membrane blood pump fixedly connected to said housing at said one end thereof, and

a flexible blood storage bag connected to receive blood from said blood pump.