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, a patient data generation means configured to generate the patient data during external cardiac compression carried out on the patient, wherein the computer means comprises memory means having stored therein a predefined definition of the electrical signal as a response to the patient data, and the patient data generation means is configured to sense biosignals from a blood vessel or a tissue compartment, and the redistribution component comprises or consists of an aortic perfusion pump, and the device further comprises 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 aortic perfusion pump in the aorta based on the biosignal determined by the first sensor.

2. The device according to claim 1, where the at least one first sensor comprises a pressure sensor.

3. The device according to claim 1, where the first sensor is located on the redistribution component to determine the biosignal in a position distal to the aortic perfusion pump.

4. The device according to claim 1, where the device is configured to use data from the first sensor in combination with data from sensors located at other locations.

5. The device according to claim 1, 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.

6. The device according to claim 1, where the computer means is configured to receive input data from the redistribution component.

7. 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, wherein said redistribution is accomplished by occlusion of the aorta caudal to the left subclavian artery; said chest compression is manual or accomplished by the use of a mechanical chest compression device wherein occlusion is accomplished by introducing a device according to claim 1 into the aorta, and subsequently decreasing or interrupting the blood flow distal to the redistribution component by expanding the redistribution component of said device which acts during or as a bridge to one or more of angioplasty, including PCI and angiography; ventricular assist devices; heart transplantation, including artificial heart transplantation; CABG surgery and valve surgery; placement of external or internal pacemaker or ICD; ECMO; ECLS; and cardiopulmonary bypass.

8. The method according to claim 7, 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.

9. The method according to claim 7, wherein the device is introduced into the aorta via the femoral artery.

Description

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

(1) In the following, embodiments of the invention will be described in further details with reference to the drawing in which:

(2) FIG. 1 illustrates a device according to the invention;

(3) FIG. 2 illustrates functions of a device according to the invention;

(4) FIG. 3 illustrates a user interface;

(5) FIG. 4A illustrates a transverse view of a digital sensing component;

(6) FIG. 4B illustrates a longitudinal view of the digital sensing component illustrated in FIG. 4A;

(7) FIG. 5 illustrates software functions;

(8) FIGS. 6-7 illustrate an aortic expansion member;

(9) FIG. 8 illustrates a user interface screen on a PC;

(10) FIG. 9 illustrates placement in a human being;

(11) FIG. 10 illustrates attachment of the device to a limp of a patient;

(12) FIG. 11 illustrates a retrograde pump; and

(13) FIGS. 12A-12E illustrate an implanted device.

(14) 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.

(15) 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.

(16) 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.

(17) 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

(18) 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.

(19) 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.

(20) 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.

(21) 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.

(22) 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.

(23) 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.

(24) 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.

(25) The balloon may be configured in size to occlude the aorta of the patient.

(26) The sensors may pressure sensors of the type MEMS, e.g. MEMS pressure sensor, MEM2000, Metallux Switzerland.

(27) 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.

(28) 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.

(29) 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.

(30) 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.

(31) 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.

(32) 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.

(33) 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.

(34) 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.

(35) Expectedly, the system includes a variation of the above configurations and modes.

EXAMPLE 1

Operation of a Device of the Invention

(36) 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.

(37) Position Verification Mode

(38) 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.

(39) 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.

(40) Actuator (Inflation) Mode

(41) 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.

(42) 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.

(43) Self-Adjustment Mode

(44) The indicator Balloon filled? starts blinking green. The self-adjustment mode regulates the pressure in the balloon to a correct pressure according to the criteria.

(45) 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.

(46) Deflation Mode

(47) The indicator Pumping ? starts blinking yellow. The actuator is activated and the balloon is deflated.

(48) When the balloon is deflated Balloon deflated? starts blinking blue until the user presses INFLATE again.

Glossary

(49) P1 is Pressure sensor 1, as illustrated in FIGS. 1, and P2, is pressure sensor 2.

(50) Positioning Criteria

(51) 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.

(52) Filling Criteria

(53) P2 reach the pressure measured by P1?120. 50 Hz

(54) Self-Adjustment Criteria

(55) P2 is still within the following range: (P1?1.10)-(P1?1.30). 0.1 Hz.

(56) The device may signal the user with the following visual and/or auditory signals: Message A: Filling. Continue CPR. Message B: Retry placement. Balloon is now empty. Message C: Aorta Occlusion success. Message D: Deflation done.

EXAMPLE 2

Simulation Experiment

(57) 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.

(58) 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.

(59) 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

(60) 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.

(61) 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.

(62) 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.

(63) ROSC was defined as a pulsatile rhythm with a systolic aortic blood pressure>60 mm Hg maintained for at least 5 min.

(64) 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.

(65) 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.

(66) 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%.

(67) 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.

(68) 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.

(69) 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.