Cardiopulmonary resuscitation-assist ballooned catheter device (CPR-ABCD)

Abstract

The invention provides an occlusion catheter (1) for placement within a large vessel (2) of a patient with a proximal (15) balloon (3) and a distal (16) uni-level dual-balloon complex (4,5) wherein absolute or partial-isolation of the three main zones of the aortic tree (zone I (6), zone II (7) and zone III(8)) is facilitated through selective inflation and deflation of corresponding balloons. The catheter comprises an elongated catheter body (1), a septum (9) extending longitudinally through the interior of the catheter body (1) to the mid-portion (10) thereof to divide the interior of the catheter body into a primary dominant semilunar / semicircular lumen (11) and a secondary O-shaped lumen (12) which correspond to separate injection conduits (13, 14) at proximal (15) end. The secondary lumen has curved or angled internal walls at the distal end to terminate at the side port (17) located adjacent to the distal portion of the proximal balloon (3). The secondary lumen (12) which corresponds to zone II (7) can be duplicated in the design of the tube to allow for an emergent concurrent dialysis to attenuate hemodynamic compromise. The dominant lumen (11) extends longitudinally to terminate at the port (18) located on the distal (16) tip of said catheter body (1). A J- tipped guide wire (19) extends from the corresponding conduit of the dominant lumen (11) to exit the distal port (18) of the catheter body to facilitate tube insertion into the femoral (20) artery by employing Seldinger technique.

Description

CARDIOPULMONARY RESUSCITATION-ASSIST BALLOONED CATHETER DEVICE (CPR-ABCD)FIELD OF THE INVENTION

[0001] The invention generally relates to percutaneously introduced intra-arterial occlusion catheters, and more particularly to such a catheter for insertion into a large blood vessel of a patient to be used in cardiopulmonary resuscitation.CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a continuation of applications : Application No. JP5111767B2 and Application No. PCT / US2016 / 023223BACKGROUND OF THE DISCLOSURE

[0003] An intra-arterial catheter is a plastic tube, which is used in different sizes depending on the intended purpose. Among these goals, it is possible to block the aorta in the condition of aortic injury, or in patients with low systolic blood pressure, with the aim of isolating the cardio-pulmonary-cerebral arterial circulation, and providing sufficient blood perfusion to such vital organs. One of the main causes of death in critically ill trauma and non-traumatic patients, who suffer from deep shock, is the inability of the heart to provide the necessary blood for the functioning of vital organs, such as the heart, lungs, and brain. In the past, one of the methods of dealing with visceral artery bleeding and isolating blood in the cardio-pulmonary-cerebral system, in trauma patients with hemorrhagic shock, was to perform a posterolateral thoracotomy in the emergency room and cross-clamping the aorta above the diaphragm. This operation iis not only very time-consuming, it is often impossible to perform due to the lack of a skilled surgeon. In addition, in a field full of blood, finding the aorta is not so easy. Also, performing such a extensive procedure requires special tools that are usually not available in the emergency department of the hospital . It is worth mentioning that this procedure is one of the most common causes of needling and the transmission of various diseases due to its extensiveness and urgency.

[0004] In another scenario, there are patients who experience circulatory collapse during CPR for reasons other than hemorrhagic shock. In such patients, by blocking the downstream aorta, the cardio-pulmonary-cerebral circulation of the patient is isolated and the systolic pressure is maintained. However, this application is a modification of resuscitative endovascular balloon occlusion of the aorta (REBOA) which is proposed to be a more suitable adjunct to standard treatments during cardiopulmonary resuscitation in patients with non-traumatic cardiac arrest (NTCA) which increases cerebral and coronary perfusion pressure by increasing the afterload of the left ventricle, thus improving the chances of ROSC (return of spontaneous circulation) and decreasing hypoperfusion to the brain as well as selective perfusion to kidneys and liver by the applicant based on clinical decision and duration of resuscitation.

[0005] Furthermore, as mentioned, time is a critical element in cardiopulmonary resuscitation of a patient in shock. One of the primary measures in approaching such a disease is to get large IV lines to administer vasoactive drugs, bicarbonate, etc., as well as prescribing crystalloid serums and blood products. The ports built into this device allow the simultaneous administration of drugs necessary in the CPR process, as well as the administration of blood and serum products. In this way, with this device, not only the time required for IV line installation is saved, but it will also be economical.

[0006] The semilunar shape of the dominant balloon sited the distal end of the catheter permits a necessary fraction of blood to flow through it to zone II of aorta where a leastamount of blood circulation would be vital to maintain kidneys and liver whilst the axillary balloon is deflated following return of spontaneous circulation. The axillary distal O-shaped balloon is inflated at the initial resuscitative attempt to provide sufficient blood volume for vital organs fed by zone I of the aorta. The sphericity of the proximal balloon completely occludes the aortic lumen and isolates the blood in the suprarenal circulation system thus mitigates the detrimental effects of hypoperfusion to vital organs whilst the perfusion of the vital organs is established by preventing blood flow to zone III of the descending aorta.

[0007] The presence of a dynamic intra-arterial pressure monitoring probe, which is connected to a transducer at the other end, enables decisions about the adequacy of resuscitation, more accurately than any other method, before laboratory results are ready.

[0008] According to the scales measured on the catheter, which correspond to different regions of the aorta, the catheter can be stabilized in its place by using anatomical landmarks, without imaging.

[0009] Today, to maintain systolic blood pressure in trauma patients, emergency thoracotomy and use of REBOA are performed. In relation to thoracotomy, the constant lack of trauma surgeons and necessary equipment in the trauma department, as well as the high morbidity and mortality of this operation, practically limit its use. If it is used after a 15 minute interval of ineffective closed-chest CPR, it potentially improves outcome. If direct cardiac massage is delayed for more than 20 minutes, however, there is no proof of improved outcome. The hypothesis of the use of Zone 1 REBOA in NTCA has been put forward in recent years, proposing as a rationale the increased perfusion of the organs upstream of the occlusion during CPR.

[0010] The progressive development and implementation of extracorporeal cardiac life support (ECLS) have given rise to a series of new considerations on additional treatments for NTCA; unfortunately, this technique is quite expensive, challenging interms of logistics, and requires advanced skills not yet available on a large scale. Thus, it is worth considering the use of a new modification of REBOA in NTCA, as this method, which is cheaper and carries a shorter learning curve, can play an important role as an adjunct treatment in settings where the implementation of an ECLS program is not currently feasible.

[0011] The REBOA available in the market also has only one expandable balloon, which carries the risk of ischemia of the downstream viscera, so its use should be as short as possible. Also, in non-trauma patients who are in shock, there is no similar tool to isolate blood in the cardio-respiratory-cerebral system with the aim of maintaining blood pressure and perfusion of these vital organs.

[0012] Intra-aortic balloon catheters are used in the design of this disclosure. The basis of the mechanism of this invention is the use of expandable balloons above and below the place where the renal arteries are branched. The distal cuff is notched in transverse section and the proximal cuff is completely spherical. The slitting of the cross section of the distal cuff, which is placed in the suprarenal aorta, causes blood to continue perfusion of the kidney by moving distally to the distal balloon during the resuscitation process. The proximal balloon, which is placed in the intrarenal aorta, prevents the blood from passing down and completely blocks the blood circulation system. The presence of two other lumens, one distal to the distal cuff and one distal to the proximal cuff, for drug administration, increases the bioavailability of the drug by administering the drug in the desired location (in the renal arteries or close to the heart). Also, if needed, by inserting a probe and connecting it to the transducer through one of these ports, dynamic intra-arterial pressure can be measured.

[0013] A patient who comes to the hospital emergency department with heart failure and respiratory arrest needs to perform cardiopulmonary resuscitation (CPR). One of the main goals in resuscitation is to maintain central arterial pressure. With the help of the Seidinger technique, the intra-aortic catheter enters the femoral artery and is sent up according to the lines measured on the catheter. First the distal cuff and then theproximal cuff are expanded with a syringe. Through the lateral port, crystalloid serum or blood products (in trauma cases) can be administered. To improve renal perfusion, fenoldopam can be injected into the lumen that opens distally to the proximal cuff. To increase the contractility of the heart, in cases of cardiogenic shock, dobutamine is administered into the lumen that opens at the tip of the catheter. After administration of fluids and drugs, in order to monitor the adequacy of resuscitation, the probe inside the catheter is connected to the transducer and the dynamic arterial pressure is measured. Finally, after the CPR process is completed and the patient's hemodynamics is stabilized, the cuffs are deflated and the catheter is removed.SUMMARY OF THE INVENTION

[0014] An An occlusion catheter system includes an elongated double lumen catheter body for large vessel occlusion by inserting the catheter into a blood vessel over a Seidinger guidewire. The catheter includes an elongate body and a tip at the distal end of the body. The body has an outer wall and an integral internal C- shaped septum combining with the outer wall to define a main lumen extending longitudinally to terminate at the longitudinal extremity of the tip to receive the guidewire during insertion and to provide a path for the medicament after insertion and a side lumen extending to the mid-body. The septum disappears distal to the side port of the side lumen. Said catheter has three proximal hubs having three discrete inflation connection ports and inflation connection pathways with three expandable and deflatable balloons, a single midportion cross-sectionally circular balloon when inflated and a complex of two adjacent balloons (a dominant balloon and an auxiliary balloon) at the same level at distal end thereof to make a unit circular balloon at cross section when both inflated. As well as the occlusion system, there are two injection ports having separate injection lumens to end to the corresponding pair of lumens with the ports at the end of the said main and side lumens. Another feature of the art is a proximal transducer with two luminal probes corresponding to zone I and zone II of aorta distally positioned to the proximal balloon and distal balloons respectively. A guide wire with an atraumatic J-shaped tip extends from a proximal injection port through main lumen to exit the distal port at thetip of the catheter body which is removed following catheter placement. The guide wire tip has a substantially circular profile in a relaxed configuration.

[0015] One of the main measures of CPR in patients is to maintain central arterial blood pressure to establish tissue perfusion to vital organs. In cases of trauma, one of the measures to do this is emergency thoracotomy and cross-clamping of the aorta, for which problems such as the unavailability of a surgeon, complexity, and high mortality and morbidity have been mentioned. A newer method is to use REBOA. In the present disclosure as a modification of prior arts, three expandable cuffs are placed on the catheter inflated through three discrete members, a complex of two cuffs proximal to the renal artery branching (distal cuffs) and one single cuff distal to the renal artery branching (proximal cuff).BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 is a side elevational view of the invention shown in operating position against a facial outline; and

[0017] FIG. 2 is a diagrammatic perspective view of occlusion catheter device; and

[0018] FIG 3 is a cross-sectional view of the catheter where the proximal balloon is sited ; and

[0019] FIG 4 is a cross-sectional view of the catheter where the distal balloons are sited.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0020] The invention will be described in detail with reference to a preferred embodiment to be used for vital organs preservation in serious hemodynamic compromise. However, the drawings and description are exemplary of the invention and unless otherwise stated, are not intended to be limited by its restraints of size and properties dictated by resuscitative procedures.

[0021] The catheter body (1 ) comprises an external wall (21 ) and a septum (9) extending longitudinally mid-way along the internal length of the catheter body (2) to define twosubstantially parallel lumina each having an internal wall and a port (17, 18) located at the distal end thereof known as the main lumen (1 1 ) and the secondary lumen (12).

[0022] At the distal end of secondary lumen, at least a portion of the internal walls of the lumina are curved or angled to define a transition zone terminating at the side port (17). So, configured, the transition zone permits the flow of fluids traveling the length of the lumen to be gradually deflected from the longitudinal direction of the lumen to the transverse direction of the side-facing port (17) at the distal end thereof.

[0023] The primary lumen has a transition of cross-section shape in mid-portion of the catheter body from a C-shape (Fig 3. 11 ) to O-shape (Fig 4. 1 1 ) as it passes the distal portion of the secondary lumen to terminate at the distal port (18) located at the distal tip of said catheter body (1 ).

[0024] The catheter (1 ) is secured to a conventional dressing by an attachment fitting having wing tabs (15). The catheter (1 ) passes through the dressing and an elongate and flexible cylindrical body (1 ), formed of a polyurethane extrusion, is inserted through the skin and into the femoral artery (20) in the upstream direction. The catheter (1 ) has at its distal end (16) a conical tapered tip (18). The other end of the body is a generally dual-shaped branching connector (22), which protrudes outwardly from and is secured by dressing.

[0025] FIG. 2 and 3 show the catheter (1 ) in greater detail. The body (1 ) comprises an outer wall (21 ) and an integral septum (9) extending diametrically across the body (1 ) and defining a primary lumen (1 1 ) and a secondary lumen (12). The secondary lumen (12) is O- shaped in cross section and extended from the proximal end to mid-portion of the body (10). A duplicate secondary lumen can be incorporated in the design of such resuscitative device to allow for emergent closed-loop short term dialysis to remove blood from zone II of the aorta for processing and return processed blood to the same zone wherein said zone is isolated in serious hemodynamic conditions. The primary lumen (1 1 ) is D-shaped or C-shaped in cross-section ( in models with or without duplicated secondary lumen, respectively ) from proximal end to mid-portion (10) of the body (1 ) due to the common path with secondary or a tertiary lumen anddiametrical division of the body (1 ) by thr integral septum (9). There is an O-shape transition of the primary lumen from mid-portion to the distal end (16) as the common path ends within the tube body and the primary lumen extends beyond the end of the secondary lumen. The primary (1 1 ) and secondary (12) lumens have at their proximal end the connector (22) for administration of crystalloid serums or coloid products as well as resuscitative drugs. These tubes terminate at their outer ends in respective female luer fittings (23) for connection to complementary male luer fittings (not shown) leading to a transfusion set.

[0026] The primary lumen (1 1 ) permits the Seidinger wire (19) to pass through the catheter body (1 ) to exit at tip (18) which is essentially conical so that the catheter can slide over the wire and into the patient during insertion. The guide wire (19) is inserted into the primary lumen (1 1 ) and used to assist in the introduction and proper placement of the catheter tip (18) into a vessel (20) of a patient.

[0027] The corresponding zone I (6) and zone II (7) conduits (14, 13) are linked at connector (22) with lumens in the body (1 1 , 12) to connect with respective tip and side apertures (18, 17) for intravenous infusion of liquid medicaments, respectively.

[0028] Turning now to the embodiment that is shown in the drawings and referring to FIGS. 1 , 2, 3 and 4, there is shown a catheter (1 ) having a single proximal balloon (3) and a uni-level dual balloon complex (4,5) named as the dominant balloon (4) and the auxiliary balloon (5) system at distal end of said catheter body (1 ) matched to provide a patrial versus complete occlusion of the vessel by selective deflation versus a full inflation of the auxiliary balloon (5), respectively.

[0029] While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents,and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims. In addition, all the disclosed embodiments may be fabricated in different sizes and configurations to accommodate differences in the age or anatomy of the patient population.THE ADVANTAGES OF THE INVENTION OVER THE PREVIOUS MODELS

[0030] - More compatibility for cardiopulmonary resuscitation

[0031] - Restricting the aortic blood flow to zone III of the aorta and enhancement of the arterial blood volume in zones I and II of the aorta in order to maintain or improve perfusion of vital organs in hypovolemic conditions or distributive shocks.

[0032] - The possibility of direct administration of special drugs during the resuscitation process through each of the lumens, for example, administration of drugs effective on the kidney through the side lumen, and administration of drugs of choice for organs fed by zone I of the aorta through the main lumen

[0033] - Efficient management of time and resources

[0034] - Selective regional perfusion of the aortic tree based on clinical decision of the applicant.

[0035] - Reducing existing design costs by increasing efficiency compared to existing knowledge

[0036] - Reduced technical complexities

[0037] - Single cutaneous puncture rather than multiple or multi foci punctures

[0038] - Easy application by medical staff in prehospital environmentsINDUSTRIAL APPLICABILITY OF THE INVENTION

[0039] The disclosure can be used in prehospital and clinical environments including intensive or cardiac care units, emergency departments, operating rooms with therapeutic goalsin different patients to improve hemodynamic status and maintain vital organs' perfusion to reach a better outcome following cardiopulmonary resuscitation. end

Claims

Claims

1. A large vessel (2) occlusion catheter system comprising:An elongate body (1 ) extending about a longitudinal axis from a proximal (15) end to a distal (16) end;A tip (18) at the distal end of the body; the body having an outer wall and an integral internal septum (9) combining with the outer wall (21 ) to define a pair of C-shaped (1 1 ) and O-shaped (12) lumens extending longitudinally to mid- portion (10); the side lumen (12) is O-shaped extending from proximal end (15) to terminate at the side port (17) in the mid-portion (10) and the main lumen (11 ) is C- shaped from the proximal (15) end to mid-portion (10) and O- shaped from mid-portion (10) to extend longitudinally to terminate at longitudinal extremity of the tip (18) so that the main lumen is as long as the catheter; a connector (22) attached to said proximal (15) end of the body (1 ) ; a pair of tubes attached to the connector (13, 14) and coupled by the connector (22) to the respective main (11 ) and side (12) lumens to deliver necessary liquids and drugs, said conduits (1 1 , 12) sealed from fluid communication with each other to end to the corresponding proximal (17) and distal (18) ports; a guide wire (19) with an atraumatic J-shaped tip extends from a proximal injection port (23) through main lumen (11 ) to exit the distal (16) port (18) of the catheter system at the tip;Three proximal hubs (25) having three discrete inflation connection ports (24) and three inflation pathways (26) defined in the corresponding connection ports;Three separate inflation catheter members (27, 28, 29) connected to the proximal corresponding hubs (25), and each inflation catheter member having an inflation lumen and a first port (30) proximate a distal end of the inflation catheter member (26);Three occlusion balloons (3, 4, 5) having proximal and distal balloon ends, the proximal balloon ends connected proximate to the distal end (31 ) of the corresponding inflation catheters; a pressure sensor (32) connected to the occlusion catheter system with two electrodes (33, 34) distally relative to the proximal (3) and distal occlusion balloons (4, 5), the pressure sensor connected to a processor by electrical wiring. Claim 2] The occlusion catheter system of the claim 1 , wherein the distal balloons (4, 5)are positioned at the same level with difference in volume and cross sectional shapes (C- shaped (4) and O- shaped (5) ) and independently inflated combined to bring about complete occlusion of the aorta lumen at diaphragm (35) level to isolate zone I (6) of the aorta when the catheter is in its optimal position with both balloons fully inflated as well as partial occlusion of the aorta with deflation of the auxiliary balloon (5) (O-shaped balloon); Claim 3] The occlusion catheter system of claim 1 , wherein the dominant (4) and the auxiliary (5) balloons are C-shaped and O-shaped in cross section, respectively;

4. The occlusion catheter system of the claim 1 , wherein the single proximal balloon (3) is defined to seperate zones II (7) and III (8) of the descending aorta when the occlusion catheter system is properly positioned and a perfect sphere shape in cross section of the balloon is defined when fully inflated; Claim 5] The occlusion catheter system of claim 1 , wherein each balloon leads to a separate inflation lumen, the end of which reaches the end of the assembly outside the body.

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