Device and a method for providing resuscitation or suspended state in cardiac arrest

Abstract

Disclosed is a device for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient. The device includes an electrically controllable redistribution component attachable to the patient to provide redistribution of the cardiac output to increase supply to the brain and heart. The redistribution component, following a predefined reaction pattern based on an electrical signal, and computer means configured to: receive a patient data which identifies physiological and/or anatomical characteristics of the patent; and provide the electrical signal for the redistribution component based on the patient data or a standard response. The device may provide mechanisms to protect the aorta and the remaining anatomy of the patient from inadvertent damage caused by the disclosed device in any usage scenario of either correct intended usage or unintended usage. Also disclosed is a method for providing resuscitation or suspended state.

Claims

1. A device for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient, the device comprising an electrically or manually controllable redistribution component attachable to the patient and being configured to interact with the patient to provide redistribution of the cardiac output to increase supply to the brain and heart, the redistribution component following a predefined reaction pattern based on an electrical signal, and computer means configured to: receive a patient data which identifies physiological and/or anatomical characteristics of the patient; and provide the electrical signal for controlling the redistribution component and/or for presenting the physiological and/or anatomical characteristics for a user based on the patient data or a standard response.

2. The device according to claim 1, where the computer means comprises memory means having stored therein a predefined definition of the electrical signal as a response to the patient data.

3. The device according to claim 1 or 2, comprising patient data generation means configured to generate patient data during external cardiac compression carried out on the patient, the patient data generation means configured to generate the patient data by sensing biosignals from the patient.

4. The device according to claim 3, where the patient data generation means is configured to sense biosignals from a blood vessel or a tissue compartment.

5. The device according to any one of the preceding claims, wherein the redistribution component comprises or consists of an aortic retrograde perfusion pump.

6. The device according to any of claims 1-4, where the redistribution component comprises an elongated body extending between a proximal end and a distal end, the distal end being insertable into the patient, where the redistribution component comprises an aortic expansion member and inflation means connected to the aortic expansion member for expanding the aortic expansion member.

7. The device according to claim 6, wherein the inflation means is adapted to be capable of being operated manually by a user.

8. The device according to claim 6 or 7, wherein the inflation means is adapted to be capable of being operated automatically.

9. The device according to any one of claims 6-8, further comprising an adaptable tissue protection mechanism configured to: determine a blood pressure or blood flow present in a blood vessel of the patient during cardiac compression; determine an aortic expansion member characteristics defining a degree of expansion of the aortic expansion member based on the determined blood pressure or blood flow; and to provide an electrical signal for controlling the inflation means in accordance with the determined aortic expansion member characteristics.

10. The device according to claim 9, where the adaptable tissue protection mechanism is configured to determine the aortic expansion member characteristics based on the determined blood pressure or blood flow multiplied by a predetermined factor.

11. The device according to any of claims 6-10, where the electrical signal specifies a degree of expansion of the aortic expansion member, a timing of expansion of the aortic expansion member, an upper limit of expansion, a duration of expansion of the aortic expansion member, and/or a timing of contraction of the aortic expansion member.

12. The device according to any of claims 6-11, where the inflation means comprises a piston or roller pump.

13. The device according to 6-12, further comprising a location safety mechanism comprising at least one first sensor capable of determining a biosignal which is characteristic for aorta of the patient and an electronic circuit configured to verify a position of the expansion member in aorta based on the biosignal.

14. The device according to claim 13, where the at least one first sensor comprises a pressure sensor.

15. The device according to claim 13 or 14, where the first sensor is located on the redistribution component to determine the biosignal in a position distal to the aortic expansion member.

16. The device according to claim 15, where the device is configured to use data from the first sensor in combination with data from sensors located at other locations.

17. The device according to claim 16, where at least one of the other sensors is located on the redistribution component to determine the biosignal in a position proximal to the aortic expansion member.

18. The device according to any of claims 13-17, where the location safety mechanism is configured to determine whether the aortic expansion member is located in a position selected from a group consisting of: a pulsating vessel in accordance with being the aorta of the patient, a pulsating vessel not in accordance with being the aorta, a pulsating vessel being indeterminate as the aorta of the patient, a venous vessel, a tissue compartment not being a blood vessel and a tissue compartment indeterminate in location.

19. The device according to any of claims 13-18, further comprising a second sensor inside the aortic expansion member or proximal to the expansion member.

20. The device according to any of claims 13-19, wherein the device is configured with a feedback loop receiving data from at least one of the first and second sensor, to control the filling of the aortic expansion member.

21. The device according to any of the claims 6-20, further comprising a first failsafe mechanism, configured to determine a pressure in the aortic expansion member and to determine a volume of the aortic expansion member, to determine a ratio between the pressure and the volume, and to compare the ratio with an upper and lower threshold value, and to execute a control sequence including stopping of further inflation of the aortic expansion member or deflation of the aortic expansion member.

22. The device according to any of claims 6-21, further comprising a user interface for use of selectable operation of the inflation means.

23. The device according to any of claims 6-22, comprising a halt interface allowing manually selectable deflation of the aortic inflation member.

24. The device according to claim 23, where the halt interface is configured to execute the selectable deflation over a predefined number of seconds.

25. The device according to any of claims 6-24, comprising a patient state monitor configured to determine a biosignal representing Return of Spontaneous Circulation (ROSC), and to control deflation of the aortic expansion member based on the determined signal.

26. The device according to any of claims 6-25, further comprising an electronic human interface with a graphical or audio user interface configured to provide instructions or information related to the location and degree of filling of the aortic expansion member in the aorta of the patient, said human interface optionally being attachable in a fixed position on a patient.

27. The device according to any of claims 6-26, further comprising at least one sensor for determining pressure, flow, O.sub.2 saturation or concentration, and/or volume data significant for pressure, flow and/or volume of a fluid inside the aortic expansion member or inside a blood vessel or tissue of the patient.

28. The device according to claim 27, where the computer means is configured to compare the pressure, flow and/or volume data with reference input data and based on the comparison to verify a position of the aortic expansion member in the body.

29. The device according to claim 27 or 28, where the computer means is configured to determine the size and type of blood vessel by analyzing the pressure flow and/or volume data continuously.

30. The device according to any one of claims 27-29, where the computer means is configured to activate a failsafe for some verified positions in the body or limits based on sensor data analysis, thereby stopping the redistribution component interaction with the patient, the expansion of the aortic member or initiation of contraction of the aortic member.

31. The device according to any one of claims 27-30, wherein an interactive human user guide is configured to provide information related to a position of the aortic expansion member in the patient, the information being determined based on the pressure, flow and/or volume data.

32. The device according to any of the preceding claims, further comprising means for ultrasound imaging data in the guidance of the user.

33. The device according to any of the preceding claims, where the patient data includes parameters selected from the group consisting of: aortic blood pressure, aortic blood flow, duration of cardiac arrest, expiratory CO.sub.2, ECG, blood pressure, compression rate and depth, pulse, respiratory frequency, cardiac output redistribution degree, aortic O.sub.2 saturation or concentration, cerebral or peripheral saturation, temperature, fluid administered, pharmaceuticals administered, biochemical data, and ultrasound imaging.

34. The device according to any of claims 5-30, where the aortic expansion member comprises an aortic occluding balloon.

35. The device according to claim 34, further compromising means for filling the aortic occluding balloon with a liquid or a gas.

36. The device according to claim 35, further comprising a handheld unit comprising the computer means and the filling means and being attachable to the aortic occluding balloon.

37. The device according to claim 35, further comprising an human interface unit comprising the filling means and being attachable to the aortic occluding balloon, said human interface optionally being attachable in a fixed position on a patient and wherein said human interface is optionally integrated with the human interface defined in claim 26 and/or the handheld unit defined in claim 36.

38. The device according to claim 36 or 37, wherein the aortic occluding balloon is pre-attached to the handheld unit.

39. The device according to any of the preceding claims, where the computer means is configured to receive input data from the redistribution component.

40. The device according to any of the preceding claims, further comprising a component attachable to the patient and being configured to administer fluids and drugs to the patient.

41. The device according to claim 40, further compromising the means to administer timed and controlled amount of fluids and/or drugs.

42. The device according to any of the preceding claims, further comprising an additional component from the group consisting of: a patient monitor, a vitals signs monitor, a watch, an external chest compression device, a respirator, an ECG monitor, a defibrillator, a pacemaker, a pH measurement device, an ultrasound device, an ECMO/ECLS device, a body cooling device, an infusion pump, a capnograph, a ventricular assist device, a dialysis device, touchscreen and/or telecommunications device.

43. The device according to any of the preceding claims, the redistribution component comprising of a component with the means for tilting the patient in a head down or head up tilt.

44. The device according to any of the preceding claims, further comprising means for a self-test system, double circuitry, and usage event data recording.

45. The device according to any one of the preceding claims, wherein the computer means communicates with at least one other therapeutic and/or monitoring device so as to allow coordination of the operation of said therapeutic devices and the device according to any one of the preceding claims.

46. The device according to claim 45, wherein the at least one other therapeutic and/or monitoring device is selected from a cardiac resynchronization therapy device, a cardioverter-defibrillator, and a cardiac pacemakers.

47. A method for providing resuscitation or suspended state in a human cardiac arrest patient, said method comprising subjecting the patient to heart massage (chest compression) while at the same time ensuring redistribution of the cardiac output to preferentially supply blood to the brain and the heart.

48. The method according to claim 47, wherein said redistribution is accomplished by at least one of the following: occlusion of the aorta caudal to the left subclavian artery; head-down or head-up tilting of the patient so as to reach an angle of between 30 and 90 degrees relative to the horizontal plane; applying an external compression force onto the abdomen and/or thigh(s) and/or arm(s) so as to reduce the perfusion distal to the external compression force; passively raising the legs to reach an angle between 30 and 90 degrees relative to the horizontal plane.

49. The method according to claim 47 or 48, wherein said chest compression is manual or accomplished by use of a mechanical chest compression device.

50. The method according to any one of claims 47-49, wherein at least one of the following treatments is/are also provided to the patient: administration of fluids, including saline and buffers such as bicarbonate, administration of vasopressive drugs, including vasopressin and analogues, administration of a tissue-protecting agent, such as erythropoietin; administration of anti-arrhythmic drug, such as amiodarone; reduction of body temperature, such as by use of cold IV-fluid infusion, cooling catheters, transnasal evaporative cooling, extracorporeal cooling or total liquid ventilation with temperature controlled perfluorocarbons.

51. The method according to claim 50, wherein the treatments are provided repeatedly, optionally according to a fixed sequence.

52. The method according to any one of claims 47-51, which comprises that redistribution is accomplished by occlusion of the aorta caudal to the left subclavian artery.

53. The method according to claim 52, wherein occlusion is accomplished by introducing a device according to any one of claims 1-46 into the aorta, preferably via the femoral artery, and subsequently decreasing or interrupting the blood flow distal to the redistribution component by expanding the redistribution component of said device.

54. The method according to claim 53, wherein the redistribution component is expanded in a controlled manner in response to measurement(s) that indicate the degree of occlusion and correct placement of said device in the patient's aorta.

55. The method according to claim 54, wherein said measurement(s) is/are selected from the group consisting of: duration of expansion redistribution component usage; blood flow passing by the redistribution component; blood pressure distal of the redistribution component, optionally combined with blood pressure proximal to the redistribution component; aortic O.sub.2 saturation distal of, and preferably in close proximity to, the redistribution component, optionally combined with arterial O.sub.2 saturation proximal of the redistribution component.

56. The method according to any one of claims 53-55, wherein expansion of the redistribution component is controlled manually or by the computer means of said device to avoid incorrect positioning or expansion degree of said device and by activating the failsafe of claim 9 in case said device is verified to be incorrectly positioned thereby interrupting the expansion of the redistribution component to allow subsequent correct positioning.

57. The method according to any one of claim 47-56, wherein the redistribution is temporarily interrupted at regular or irregular intervals so as to ensure sufficient perfusion of all parts of the body of the patient.

58. The method according to any one of claims 47-57, which acts during or as a bridge to one or more of therapeutic hypothermia; angioplasty, including PCI and angiography; dialysis; administration of drugs such as vasopressors, thrombolytic drugs such as fibrinolytics, fluids, bicarbonate, antidotes, and antiarrhythmic drugs; the use of ultrasound, X-ray, CT, or MR; intubation; mechanical ventilation; ventricular assist devices; heart transplantation, including artificial heart transplantation; surgery, including CABG surgery and valve surgery; blood transfusion; placement of external or internal pacemaker or ICD; catheter ablation; thromboendarterectomy; defibrillation; transportation; ECMO; ECLS and cardiopulmonary bypass.

59. The method according to any one of claims 47-58, further comprising lowering the restriction on perfusion delivered to the brain and heart through the use of a vasodilator, hereunder specifically sodium nitroprusside or nitroglycerin and repeated administration of sodium nitroprusside or nitroglycerin, hereunder repetition in intervals of 2-10 minutes.

60. The method according to claim 59, further comprising the use of an aortic expansion member to prevent the systemic vascular collapse caused by the vasodilator.

61. The method according to any one of the preceding claims, further comprising the use of any one of the following: active compression-decompression CPR, impedance threshold device, adenosine administration, controlled pauses in the CPR (e.g. compressions for 20 seconds, then a pause in compressions for 20 seconds.)

62. A method for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a human in cardiac arrest or imminent cardiac arrest, the method comprising subjecting the patient to external chest compression while at the same time ensuring redistribution of the cardiac output accomplished by occlusion of the aorta caudal to the left subclavian artery, and comprising lowering the restriction on perfusion delivered to the brain and heart through the use of a vasodilator, hereunder specifically sodium nitroprusside or nitroglycerin, hereunder repetition in intervals of 2-10 minutes.

63. A method according to claim 62, further acting as a bridge to one or more of the following: ECMO; ECLS; cardiopulmonary bypass; angioplasty, including PCI and angiography; dialysis; therapeutic hypothermia, hereunder cold IV-fluid infusion, cooling catheters, transnasal evaporative cooling, extracorporeal cooling or total liquid ventilation; administration of drugs, hereunder vasopressors or vasodilators, hereunder sodium nitroprusside or nitroglycerin, thrombolytic drugs such as fibrinolytics, fluids, bicarbonate, antidotes, tissue-protecting agents and antiarrhythmic drugs, such as amiodarone; the use of ultrasound, X-ray, CT, or MR; intubation; mechanical ventilation; ventricular assist devices; surgery, including CABG surgery and valve surgery; blood transfusion; placement of external or internal pacemaker or ICD; catheter ablation; thromboendarterectomy; heart transplantation; defibrillation; transportation.

64. A method for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a human in cardiac arrest or imminent cardiac arrest, the method comprising subjecting the patient to external chest compression while at the same time ensuring redistribution of the cardiac output accomplished by sustained abdominal compression or abdominal binding, and comprising lowering the restriction on perfusion delivered to the brain and heart through the use of a vasodilator, hereunder specifically sodium nitroprusside or nitroglycerin, hereunder repetition in intervals of 2-10 minutes, and comprising acting as a bridge to one or more of the following: ECMO; ECLS; cardiopulmonary bypass; angioplasty, including PCI and angiography; dialysis; therapeutic hypothermia, hereunder cold IV-fluid infusion, cooling catheters, transnasal evaporative cooling, extracorporeal cooling or total liquid ventilation; administration of drugs, hereunder vasopressors or vasodilators, hereunder sodium nitroprusside or nitroglycerin, thrombolytic drugs such as fibrinolytics, fluids, bicarbonate, antidotes, tissue-protecting agents and antiarrhythmic drugs, such as amiodarone; the use of ultrasound, X-ray, CT, or MR; intubation; mechanical ventilation; ventricular assist devices; surgery, including CABG surgery and valve surgery; blood transfusion; placement of external or internal pacemaker or ICD; catheter ablation; thromboendarterectomy; heart transplantation; defibrillation; transportation.

65. A method for stopping or reducing bleeding from tissue(s) or organ(s), hereunder during e.g. surgery or other situations where bleeding occur of said tissue(s) or organ(s), the method comprising inserting an occlusion device into a blood vessel, which supplies said tissue(s) or organ(s) with blood, wherein said occlusion device is reversibly expanded to occlude said blood vessel and wherein the pressure exerted by the expanded occlusion device on the wall of the blood vessel is adapted to be between 1 and 2 times the vascular pressure difference across the occlusion device.

66. The method according to claim 65, wherein the pressure exerted by the expanded occlusion device on the wall of the blood vessel is adapted to be at most 1.9 times the vascular pressure difference across the occlusion device, such as at most 1.8, at most 1.7, at most 1.6, at most 1.5, at most 1.4, at most 1.3, at most 1.2 and at most 1.1 times.

67. The method according to claim 65 or 66, wherein the occlusion device includes or is attached to at least one vascular pressure sensor, which can determine the vascular pressure in said blood vessel.

68. The method according to claim 67, wherein the at least one pressure sensor is positioned in said vessel between the occlusion in said vessel and said tissue(s) or organ(s) and/or is positioned in the part of said vessel which is separated from said tissue(s) or organ(s) by the occlusion.

69. The method according to any one of claims 65-68, wherein the occlusion device is part of a device as claimed in any one of claims 1-46, where said occlusion device is identical to the aortic expansion member of claim 6 or may be a modified version of said aortic expansion member, which is adapted be able to fit into other blood vessels.

Description

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0104] In the following, embodiments of the invention will be described in further details with reference to the drawing in which:

[0105] FIG. 1 illustrates a device according to the invention;

[0106] FIG. 2 illustrates functions of a device according to the invention;

[0107] FIG. 3 illustrates a user interface;

[0108] FIG. 4A illustrates a transverse view of a digital sensing component;

[0109] FIG. 4B illustrates a longitudinal view of the digital sensing component illustrated in FIG. 4A;

[0110] FIG. 5 illustrates software functions;

[0111] FIGS. 6-7 illustrate an aortic expansion member;

[0112] FIG. 8 illustrates a user interface screen on a PC;

[0113] FIG. 9 illustrates placement in a human being;

[0114] FIG. 10 illustrates attachment of the device to a limp of a patient;

[0115] FIG. 11 illustrates a retrograde pump; and

[0116] FIGS. 12A-12E illustrate an implanted device.

[0117] Further scope of applicability of the present invention will become apparent from the following detailed description and specific examples. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent to those skilled in the art from this detailed description.

[0118] Redistributing the cardiac output during cardiac arrest may be carried out with the device illustrated in FIG. 1, performing e.g. according to the algorithm structure illustrated in FIG. 2, and working in conjunction with a human user interface as illustrated in FIG. 3.

[0119] FIG. 1 illustrates a device 1 which contains a piston pump, a fluid container, power supply with batteries, a CPU, RAM, Memory with computer program code for the CPU, and power driven motor means for operating the piston pump.

[0120] The device is capable of providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient. The illustrated device comprises an electrically or manually controllable redistribution component in the form of an occlusion catheter sub-part 2 suitable for insertion through a femoral arterial line

[0121] The occlusion catheter facilitates redistribution of the cardiac output by reducing blood flow across a balloon which is inflated in the aorta and thereby increases supply to the brain and heart.

[0122] The device is adapted for automatic operation. The CPU is configured to receive a patient data which identifies physiological and/or anatomical characteristics of the patient and to provide the electrical signal for controlling the redistribution component and/or for presenting the physiological and/or anatomical characteristics for a user based on the patient data or a standard response. In the illustrated embodiment, the occlusion catheter comprises two sensors, one being above the balloon and one being inside the balloon, or alternatively below the balloon. The sensor may particularly be pressure sensors which can provide blood pressure which herein is considered as patient data. These patient data may be generated e.g. during external cardiac compression carried out on the patient.

[0123] The signals from the sensors are transmitted to the CPU which, based on the computer program code, controls checks the location of the catheter in the aorta and the patent safety during use of the device and which controls the filing of the balloon. The CPU thereby follows a predefined reaction pattern based on the electrical signal from the sensor.

[0124] The device has a screen 3 which forms part of a user interface. The user further comprises control buttons and visual feedback through LED lights and/or text display. As illustrated in FIG. 1, the user interface may inform the user when filling is underway, and it may further inform the user about a successful balloon occlusion and thus cardiac output redistribution or alternatively that the catheter is not at the desired location in aorta.

[0125] The digitally sensing catheter sub component may be designed as illustrated in FIGS. 4A and 4B. FIG. 4A is a transverse view and FIG. 4B is a longitudinal view. The structure and location of the sensors relative to the catheter may be as illustrated in FIGS. 4A and 4B.

[0126] The catheter body comprises an elongate tube 4 with a lumen 5 wherein saline can flow in both directions, i.e. both to and from the balloon and wherein the sensor units 6, 7 and sensor wires 8 can pass through the extent of the catheter body, as illustrated in FIG. 4B. The catheter body may be constructed from PEBAX with a working length of 75 cm. The sensors are separated by a sealing, e.g. glue, 9.

[0127] The balloon (not shown) can be made from low durometer urethane, with a wall thickness of 0.05 mm, an overall length of 30 mm, and a diameter from 20-40 mm depending on filling degree, having a burst pressure of at least 500 mmHg.

[0128] The balloon may be configured in size to occlude the aorta of the patient.

[0129] The sensors may pressure sensors of the type MEMS, e.g. MEMS pressure sensor, MEM2000, Metallux Switzerland.

[0130] The sensors can be interfaced with a print circuit board via USB. The USB connection allows for the signal to be processed digitally and used as input for the software algorithms as illustrated in FIG. 2 and FIG. 5.

[0131] The device further comprises a controller component. The controller component may contain a membrane keyboard with LEDs for user interface, integrated circuit, a pump, hereunder e.g. a piston pump or roller pump, battery, and any other additional component for controlling, powering, or operating the device in accordance with the invention.

[0132] Another embodiment of the invention is illustrated in FIG. 11. In this embodiment, the catheter component 15 of the device further compromises a retrograde pump 16 controlled by communication with the CPU contained in the external part 17 of the device. The pump could be a brushless type pump such as brushless EC6 motor from Maxon, Maxon precision motors Inc. The pump is located in the aorta 18.

[0133] The catheter subpart may be inserted into the aorta of the patient by locating and puncturing the femoral artery and by inserting the device through the defined opening. The device could be used for the puncturing and placement procedures and these procedures may be integrated into the device. The device can aid the user from unintended harmful events occurring to the patient through the active security mechanism modes illustrated in FIG. 5.

[0134] The controller component of the device can be attached or fixed to the leg 10 of a patient through e.g. a wraparound leg belt or an adhesive fixation pad. FIG. 10 illustrates an embodiment where the device 11 is strapped to the patient with a strap 12 or fixed to the patient by an adhesive 13. In both embodiments, the catheter 14 extends into the aorta through a sealed port.

[0135] In another embodiment of the invention, the device can be implanted into a patient. This device may function through wireless coordination and electricity transfer between the device and a pacemaker, ICD or similar implantable cardiovascular diagnostic or therapeutic medical device, as illustrated in FIGS. 12A-12E.

[0136] FIG. 12A illustrates a heart 19 with a pacemaker/ICD 20 communicating signals with a redistribution component 21. In FIGS. 12B and 12C, the redistribution component is a pump, and in FIGS. 12D and 12E, the redistribution component is an occlusion balloon 22.

[0137] In another embodiment of the invention, the device functions as part of a robotic puncture and insertion system, further decreasing the room for user error.

[0138] Expectedly, the system includes a variation of the above configurations and modes.

EXAMPLE 1

Operation of a Device of the Invention

[0139] The device is started by pressing the button ON or it is started by unpacking the device e.g. by releasing an attachment to the electrical circuit between device and battery. The user uncovers the catheter and inserts the catheter into the patient. Once the user has completed the procedure, the user presses INFLATE, and the system enters the Position verification mode.

Position Verification Mode

[0140] When the criteria for the correct position is met, the indicator “Position correct ✓” starts blinking green and the indicator “Pumping ⊙” starts blinking yellow, then the system enters Actuator (inflation) mode.

[0141] If the correct position is not achieved or if the correct position is lost, then indicator “Pumping ⊙” stops blinking, an alarms sounds and “Retry placement X” starts blinking, until INFLATE is pressed again.

Actuator (Inflation) Mode

[0142] The actuator is activated and the balloon is inflated. When the criteria for a filled balloon is reached the actuator is stopped, the indicator “Pumping ⊙” stops blinking yellow and Self-adjustment mode is entered.

[0143] If the criteria are not met after one minute, or the user presses the DEFLATE button, the Deflation mode is entered followed by “Retry placement X” starting to blink and staying lit until INFLATE is pressed again.

Self-adjustment Mode

[0144] The indicator “Balloon filled—.diamond-solid.” starts blinking green. The self-adjustment mode regulates the pressure in the balloon to a correct pressure according to the criteria.

[0145] If the criteria can't be held, an alarm sounds, the deflation mode is entered followed by “Retry placement X” starting to blink until INFLATE is pressed again, or if the user presses the DEFLATE button, the Deflation mode is entered.

Deflation Mode

[0146] The indicator “Pumping ⊙” starts blinking yellow. The actuator is activated and the balloon is deflated.

[0147] When the balloon is deflated “Balloon deflated—.diamond-solid.” starts blinking blue until the user presses INFLATE again.

Glossary

[0148] P1 is Pressure sensor 1, as illustrated in FIGS. 1, and P2, is pressure sensor 2.

Positioning Criteria

[0149] The maximum pressure measured by P1 is above 15 mmHg and has a delta between the max and min pressure measured higher than 5 mmHg. 50 Hz.

Filling Criteria

[0150] P2 reach the pressure measured by P1×120. 50 Hz

Self-adjustment Criteria

[0151] P2 is still within the following range: (P1×1.10)-(P1×1.30). 0.1 Hz.

[0152] The device may signal the user with the following visual and/or auditory signals: [0153] Message A: “Filling. Continue CPR.” [0154] Message B: “Retry placement. Balloon is now empty.” [0155] Message C: “Aorta Occlusion success.” [0156] Message D: “Deflation done.”

EXAMPLE 2

Simulation Experiment

[0157] A model of the human ascending aorta, aortic arch, and common femoral arteries was produced in silicone rubber. The model was submerged in water and internal pressure (100 mmHg) in the model was applied via a connected water column. Chest compressions were simulated by manually applying pressure to an attached balloon.

[0158] The test device was inserted from an opening in the part of the model corresponding to the left common femoral artery so as allow the tip to reach a position corresponding to just proximal of the renal arteries. The occlusion balloon was inflated while recording MEMS pressure sensor data from the tip of the catheter and from the interior of the balloon compartment.

[0159] It was demonstrated that the positioning and occlusion of the redistribution catheter can be controlled and verified through the use of software-hardware integration mechanisms. For example, measuring the correct pressures during filling corresponding to the catheter tip being in the aorta (and e.g. not misplaced in the renal artery) allows pressure control of the filling of the balloon as a function of the pressures intended to be countered. In other words, if the catheter is not placed in the correct position, filling of the balloon counter the aortic pressure and has the consequence that the pressure measured at the tip drops to zero instead of remaining at the level of the aortic pressure.

EXAMPLE 3

In Vivo Experiment

[0160] A prototype device was tested in two pilot animal trials. The animals were healthy Danish farm pigs of 30-38 kg, which were sedated using pentobarbital (Mebumal) 50 mg/ml, 6 mg/kg/h and ketamine (Ketaminol vet) 100 mg/ml, 15 mg/kg/h. The animals further were administered 2000 unites of unfractionated heparin.

[0161] The animals were mechanically ventilated and oxygen levels were set to 23% oxygen prior to cardiac arrest. During the experiment the animals were continuously supplied with saline (0.9% NaCl) at an infusion speed of 2 l/h.

[0162] Cardiac arrest was induced by applying 9 V DC directly to the heart by electrodes introduced via the right jugular vein. Cardiac arrest was defined as a systolic blood pressure<25 mmHg for more than 5 seconds.

[0163] ROSC was defined as a pulsatile rhythm with a systolic aortic blood pressure>60 mm Hg maintained for at least 5 min.

[0164] Arterial blood pressure, venous blood pressure and heart rate were measured with intravascular gauges in the aortic arch through the right carotid artery at the junction with the aorta, and the right jugular vein entering the central vena cava.

[0165] Pig no. 1 had the following baseline values prior to induction of cardiac arrest: heart rate 85 bpm, arterial blood pressure 98/63 mmHg, venous blood pressure 15 mmHg. After the induction of cardiac arrest, the pig was left in no-flow state for 1 min. Hereafter mechanical chest compressions were delivered with the LUCAS 2 device (Physiocontrol) continued for an additional 5 min. After the pig had sustained a cardiac arrest for a total of 6 min, the prototype device was introduced to the aorta through the right femoral artery. The parameters after the 6 min. of cardiac arrest were measured as the following: Heart rate 0 bmp, with a mechanical setting at 100 compressions/min, blood pressure was 34/23 mmHg, and central venous pressure was 20 mmHg. Hereafter the prototype device was turned on and the effect were left to take hold for 1 min. The values were measured to the following regarding 1 min of sustained use of the prototype device: Heart rate 0, with a mechanical setting at 100/compressions/min, central arterial blood pressure was 59/28 mmHg, central venous pressure was 22 mmHg.

[0166] The use of the prototype device demonstrated an increase of the central arterial pressure, and thus also of the coronary perfusion pressure and cerebral perfusion pressure, from systolic 34 mmHg to 59 mmHg, and a sustained venous pressure going from 20 to 22 mmHg. The coronary perfusion pressure, the central parameter in cardiac resuscitation, is calculated as the difference between the systolic central arterial pressure and the central venous pressure. We are thus able to demonstrate an increase of the coronary perfusion pressure with 164%.

[0167] Pig no. 2 was subjected to the same conditions as Pig no. 1, but cardiac arrest was effected by inducing blood loss (700 ml) by bleeding from the right femoral artery prior to instigation of the treatment.

[0168] Pig no. 2 had the following baseline values prior to induction of cardiac arrest: heart rate 105 born, arterial blood pressure 96/42 mmHg, venous blood pressure 12 mmHg. After blood loss the values were: heart rate: 93 bpm, arterial blood pressure: 35/20 mmHg, central venous pressure: 10 mmHg. Treatment was commenced. After 1 minute of treatment the values had changed to: heart rate: 95 bpm, arterial blood pressure: 55/30 mmHg, central venous blood pressure: 10 mmHg.

[0169] Hence, by using the prototype of the invention, it was achieved to obtain a 57% increase the arterial blood pressure, whereas an 80% increase in coronary perfusion pressure was obtained.