DEVICE FOR TREATING AN INDIVIDUAL SUFFERING FROM CARDIAC INSUFFICIENCY, CARDIAC ARREST, CIRCULATORY ARREST OR STROKE

• US 20120203158A1
• Filed: 10/11/2010
• Published: 08/09/2012
• Est. Priority Date: 10/12/2009
• Status: Active Grant

• Current Assignee: ResuSciTec GmbH
• Original Assignee: ResuSciTec GmbH
• Inventors: Beyersdorf, Friedhelm
• Granted Patent: US 9,402,952 B2
• Time in Patent Office: Days
• US Class Current: 604/4.01
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• 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 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2005/006 for gases, e.g. CO2
• CPC Class Codes: A61M 2005/14272 for emergency, field or home use, e.g. self-contained kits to be carried by the doctor
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/0486 Glucose
• CPC Class Codes: A61M 2202/06 Solids
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 2230/202 : partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2250/00 : Specially adapted for animals
• CPC Class Codes: A61M 5/1408 : in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/44 : having means for cooling or heating the devices or media
• CPC Class Codes: A61P 7/08 : Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04

Abstract

The invention relates to a device for treating an individual suffering from cardiac or circulatory arrest or from a stroke, comprising blood withdrawal means (BE) that can be applied to the individual (P), an analysis unit (BA) directly or indirectly connected to the blood withdrawal means for detecting and providing, in the form of a blood analysis result (BAE), at least one characteristic of the blood, directly or indirectly connected to a return means (BR) that can be applied to the individual (P) and is designed to deliver a substance to the individual via the return means (BR).

Claims

1-26. -26. (canceled)

27. A device for treating an individual suffering from cardiac or circulatory arrest or from a stroke, comprising blood withdrawal means for application to the individual, an analysis unit directly or indirectly connected to the blood withdrawal means for detecting and providing a blood analysis result including at least one characteristic of the blood, directly or indirectly connected to a return means for application to the individual for delivering a substance to the individual via the return means;

and

an operative unit comprising at least one reservoir in which at least two substances are stored, a dosage unit combined with the at least one reservoir which, in response to the blood analysis result, selects from the at least two substances at least one substance or produces a mixture of at least two of the substances so that at least one selected substance or the mixture can be introduced into the individual directly or indirectly via the return means.

28. A device in accordance with claim 27, wherein:

the blood withdrawal means is within a blood flow path to the return means;

the analysis unit, the at least one reservoir unit and dosage unit are within the blood flow path; and

before delivery to the individual via the return means, the at least one selected substance or the mixture can be blended with the blood taken from the individual in order to obtain modified blood.

29. A device in accordance with claim 28, wherein:

at least one conveying means is within the blood flow path to provide regulated flow.

30. A device in accordance with claim 27, wherein:

the analysis unit comprises a plurality of sensors each for recording at least one blood parameter.

31. A device in accordance with claim 28, wherein:

the analysis unit comprises a plurality of sensors each for recording at least one blood parameter.

32. A device in accordance with claim 29, wherein:

the analysis unit comprises a plurality of sensors each for recording at least one blood parameter.

33. A device in accordance with claim 30, wherein:

the analysis unit records at least one blood parameter with at least one of the plurality of sensors selected from the group;

pH value, oxygen partial pressure, carbon dioxide partial pressure, potassium content, sodium content, calcium content, base excess, lactate value, glucose content.

34. A device in accordance with claim 27, wherein:

the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.

35. A device in accordance with claim 28, wherein:

the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.

36. A device in accordance with claim 29, wherein:

the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.

37. A device in accordance with claim 35, wherein:

the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.

38. A device in accordance with claim 34, wherein:

the dosage unit includes at least one mixing container which via a controllable dosing means is connected to individual reservoir chambers, and the at least one mixing container is directly or indirectly connected to the return means through a further controllable dosing means.

39. A device in accordance with claim 27, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

40. A device in accordance with claim 28, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

41. A device in accordance with claim 29, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

42. A device in accordance with claim 30, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

43. A device in accordance with claim 33, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

44. A device in accordance with claim 34, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

45. A device in accordance with claim 38, wherein:

the at least one stored substance is selected from the following substances or substance classes;

alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.

46. A device in accordance with claim 27, comprising:

an evaluation and control unit for exchanging data with the analysis unit and the dosage unit in response to a result of the blood analysis generates control signals for controlling the dosage unit.

47. A device in accordance with claim 46, comprising:

a monitoring unit including at least one measuring means for determining at least one parameter of the individual, the at least one parameter being selected from a group of physiological parameters of the individual comprising mean arterial pressure, central nervous pressure, pulmonary artery pressure, oxygen saturation and blood temperature;

whereby

the monitoring unit is connected to the evaluation and control unit to provide at least a unilateral data exchange.

48. A device in accordance with claim 27, wherein:

the analysis unit comprises a sensor for recording at least one property of the blood of the individual.

49. A device in accordance with claim 48, wherein:

the sensor unit is directly or indirectly connected to the blood withdrawal means.

50. A device in accordance with claim 48, wherein:

the sensor unit records at least one parameter of the blood;

pH value, oxygen partial pressure, carbon dioxide partial pressure, potassium content, sodium content, calcium content, base excess, lactate value and glucose content.

51. A device in accordance with claim 46, wherein:

the analysis unit, the operative unit and the evaluation and control unit are portable.

52. A device in accordance with claim 28, comprising:

a by-pass line within the blood flow path between the blood withdrawal means and the return means, a by-pass line directly upstream of the return means through which some of the modified blood returned to the individual may be supplied to the analysis unit, and in response to a comparison by the analysis unit, the dosage unit changes a quantity of the at least one substance supplied into the blood path flow for at least one determinable blood parameter.

53. A device in accordance with claim 27, comprising:

a heat exchanger directly or indirectly connected to the return means.

54. A device in accordance with claim 53, wherein

the evaluation and control unit generates control signals which are transmitted to the conveying means and to the heat exchanger so that the pressure, flow rate and temperature of the at least one substance to be introduced into the individual are selectable.

55. A device in accordance with claim 28, comprising:

an oxygen enrichment and depletion unit for the blood disposed within the blood flow path between the blood withdrawal means and the return means.

56. A method of treating an individual suffering from cardiac arrest or stroke from which blood is taken which is analyzed in a blood analyzer, a result of the blood analysis being performed by the blood analyzer and at least one evaluation criterion and from at least two stored substances a type and quantity of at least one substance or a substance mixture is determined, comprising:

a) adding in dosed form to the blood taken from the individual the at least one substance or the substance mixture which is reperfused into the individual as a perfusion solution to replace the removed blood to obtain modified blood which is reperfused into the individual or

b) the at least one substance or the substance mixture is reperfused into the individual as a perfusion solution in place of the removed blood.

57. A method in accordance with claim 56, comprising:

as part of the blood analysis, at least one determined blood parameter is compared with a nominal value and in an event of a quantitatively predeterminable deviation from the nominal value, one substance which influences the blood parameter is selected and added to the removed blood or the perfusion solution in a quantity dependent on the quantitative deviation.

58. A method in accordance with claim 56, wherein:

some of the modified blood is removed to have a repeated blood analysis; and

if the at least one determined blood parameter deviates from the nominal value, a correction to a type and/or quantity of the at least one added substance is performed.

59. A method in accordance with claim 56, wherein:

blood withdrawal, blood analysis, adding the at least one substance to the patient'"'"'s blood or the perfusion solution, as well as the reperfusion of the modified blood or perfusion solution are performed in situ.

60. A method in accordance with claim 56, wherein:

in addition to the blood analysis, at least one physiological parameter of the individual is determined, and in response to both the blood analysis result and the at least one physiological parameter of the individual, a type and quantity of the at least one substance to be added to the removed blood or perfusion solution, and pressure, flow rate and temperature of a modified blood flow or solution to be reperfused into the individual, are selected.

61. A method in accordance with claim 56, wherein:

the reperfusion of the modified blood or the perfusion solution into the patient performed at least two different areas of the body with different reperfusion parameters in terms of pressure, flow rate, temperature and/or perfusion duration.