A DOUBLE PUMP CARDIAC-RENAL ASSIST DEVICE FOR MAINTAINING CARDIAC OUTPUT AND ALTERING RENAL PERFUSION

Abstract

The present invention relates to a double pump cardiac-renal assist device, comprising a primary pump designed to offload blood from the left ventricle while maintaining cardiac output, and a secondary pump aimed at improving renal function by altering renal pressure and reducing afterload pressure on the primary pump in assisting the left ventricle, particularly during high-risk medical procedures, including both cardiac and non-cardiac interventions. The primary pump assembly that assists the left ventricle in pumping blood to the aorta and the secondary pump assembly that regulates renal perfusion by drawing blood from the descending aorta. Both pump assemblies are easily assembled or disassembled for independent or synchronized operation based on patient needs. The device incorporates expandable impellers that minimize hemolysis, an expandable stabilizer made of shape-memory alloy to maintain stability during operation, and a control unit that monitors patient-specific parameters such as pressure, flow rate, and temperature through embedded sensors.

Specification

Description:FIELD OF THE INVENTION

[0001] The present invention generally relates to a cardiac renal assist device for assisting cardiovascular and renal functions. Particularly relates to a double pump cardiac renal-assist device designed to assist Left Ventricle and improve renal perfusion during high-risk medical procedures. The device is suited for use in both cardiac and non-cardiac procedures where circulatory assistance is required.

BACKGROUND

[0002] Currently, percutaneous Ventricular Assist device (PVAD) is inserted either via femoral or via carotid artery into (i) the Left Ventricle which pumps the blood from Left Ventricle into the Aorta OR (ii) into the right heart, pumping blood from right ventricle to the pulmonary artery. The conditions in which it is used, but not limited to, are before, during or after, angioplasty, in cardiogenic shock or heart damage including acute myocardial infarction (heart attack), post-cardiotomy shock (after heart surgery). Urea output is an important parameter used by clinicians to judge how good is PVAD supporting the patient. PVAD's high operating temperature due to working against higher pressure head in aorta continues to be a challenge as higher rpms of the order of 50,000 is needed to maintain 2 - 2.5 L/min of flow rate with a 12 Fr (French) size pump. This causes blood damage.

[0003] Renal dysfunction is a frequent comorbidity in heart failure (HF) patients and can stem from intrinsic renal disease or cardiorenal syndrome (CRS) or a combination of the two. While decreased cardiac output has traditionally been considered a primary cause of renal damage in CRS, recent research papers indicate that cardiac output has a minimal role in the pathophysiology of renal dysfunction. Instead, kidneys maintain autoregulation even in the presence of reduced cardiac output.

[0004] Other factors such as low systemic blood pressure, venous congestion, elevated intra-abdominal pressures, and maladaptive neurohormonal activation more significantly contribute renal dysfunction in HF patients. Notably, low systemic blood pressure has emerged as the strongest factor associated with renal dysfunction, suggesting that there is a need for increasing systemic blood pressure with a cardiac assist device could improve outcomes in these patients.

[0005] Existing double pump cardiac assist devices have several limitations. They cannot be configured to position the secondary pump independently of the primary, making it challenging to adjust renal pressure without relocating the primary pump from the left ventricle. The rigid stabilizers offer limited flexibility, and the impellers are not effective at reducing blood damage (hemolysis), which is a significant concern at high rotational speeds. Additionally, these devices lack the capability to monitor critical temperatures during high-speed operation (up to 50,000 rpm) and do not provide real-time data on patient recovery or indicators for safely weaning off the device. Furthermore, the pumps cannot be decoupled for independent operation, limiting their overall flexibility in treatment.

[0006] US10744248B2 discloses a cardiac assistance system utilizing two pumps connected to the right and left heart systems through separate fluid channels via cannulas. While this device offers dual pump functionality for heart support, it lacks scientific methodologies to minimize hemolysis, sensors for tracking real time data, option to alter renal pressure and not just increase it, and adaptability for patient-specific conditions and fails to address how the pumps can be modified for various medical scenarios. The present invention addresses this by proposing a dual-pump cardiac-renal assist device. This system features a primary pump to support the left ventricle and a secondary pump that enhances renal perfusion by drawing blood from the descending aorta. The pumps can function either independently or in synchronization, providing greater flexibility for varying clinical conditions.

[0007] US9717833B2 describes a heart assist device with an expandable impeller pump that primarily supports patients with heart disease. However, this patent lacks the dual-pump system and fails to optimize cardiac workload and renal function simultaneously. The proposed invention introduces improvised impellers and dual-pump functionality to provide enhanced support during critical interventions, balancing both cardiac and renal functions for improved patient outcomes.

[0008] CN116036463A introduces two circulation support units that focus on generating pulsatile blood flow within the heart and aorta, aiming to support the ventricles and prevent retrograde flow. This system, however, focuses solely on cardiac function and does not address renal perfusion. The present invention overcomes this limitation by incorporating a secondary pump with adjustable features and a venturi cannula to regulate blood flow to the kidneys, reduce afterload on the left ventricle, and improve overall renal function.

[0009] US2020237987A1 presents a device with two pumps, one placed in the heart and another in the inferior vena cava. However, this system lacks a single, integrated cardiac-renal assist device and does not offer flexibility in assembling and disassembling the pumps based on the patient's medical condition. The proposed invention resolves this issue by introducing a single dual-pump cardiac-renal assistive device equipped with specially designed expandable impellers, cannulas, stabilizers, and a nitinol-made flexible shaft. These features reduce leakage losses and hemolysis, making the device more efficient, safer for prolonged use, and easier to assemble and disassemble, based on the specific needs of the patient.

[0010] To address the aforementioned shortcomings, there is a need for a flexible, single device that can be used for cardiac assistance, renal perfusion, or both simultaneously, depending on the clinician's requirements. Therefore, the present invention proposes a double pump cardiac renal assist device, specifically designed to overcome these challenges and provide enhanced support for both cardiac and renal functions.

OBJECTS OF THE INVENTION

[0011] An object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion during high-risk medical procedures.

[0012] Another object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion especially patients undergoing high risk of percutaneous coronary intervention (PCI) procedure.
[0013] Another object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion, where a primary pump assembly takes blood from the left ventricle and pumps it into the aorta, aiding in high-risk PCI procedures and cardiogenic shock by reducing the workload on the left ventricle, while a secondary pump assembly draws blood from the distal end of the descending aorta and pumps it to the proximal end, either before or after the renal arteries, thereby regulating renal perfusion and minimizing hemolysis as effective power required by primary pump reduces and thus the operating speed for desired cardiac output is reduced.

[0014] Another object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion, with a screw design provided in the device for decoupling the device, allowing the primary pump or secondary pump for independent use.

[0015] Another object of the present invention is to provide double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion as a single device to support either or both cardiac and renal functions, depending on patient's needs.

[0016] Another object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion, which is an adjustable secondary pump, allowing its position to be varied relative to the primary pump, enabling control of renal pressure while maintaining the primary pump in the left ventricle.

[0017] Yet another object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion with sensor configurations for monitoring the temperature of both the device and the blood, which is crucial for ensuring safety at high rotational speeds of 50,000 rpm, addressing a gap in the existing devices that lack temperature monitoring capabilities.

[0018] Yet another object of the present invention is to provide a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion which is affordable for treating patients during high-risk medical procedures.

SUMMARY OF THE INVENTION

[0019] The summary is provided to introduce aspects related to a double pump cardiac-renal assist device for maintaining cardiac output and altering renal perfusion during high-risk medical procedures and the aspects are further described below in the detailed description. This summary is not intended to identify essential features of the claimed subject matter nor is it intended for use in determining or limiting the scope of the claimed subject matter.

[0020] This invention provides a double pump cardiac-renal assist device aimed at enhancing cardiac output and renal perfusion during high-risk medical procedures, particularly outcomes during high-risk percutaneous coronary intervention (PCI) and patients with cardiogenic shock. The device consists of a primary pump assembly positioned at the distal end to assist in pumping blood from the left ventricle to the aorta and a secondary pump assembly positioned at the proximal end to pump blood from the descending aorta. The double-pump configuration facilitates both cardiac and renal support, with the primary pump providing ventricular assistance and the secondary pump aiding in renal perfusion through a venturi cannula that directs flow to the renal arteries.

[0021] The pump assemblies incorporate impeller with motor, which may be axial, diagonal, or centrifugal. This impeller is made of biocompatible material and provided to minimize blood stagnation, reduce leakage losses, and limit hemolysis by incorporating features such as squealers and winglets. The impeller is coupled to an external motor or flexible shaft to facilitate blood flow. The device includes a connecting shaft linking the two pumps, an expandable stabilizer to maintain device positioning, and a control unit to operate the pumps and monitor patient parameters. Further includes a catheter connected to the control unit as a conduit for supplying power and delivering purge solution to the pumps.

[0022] MEMs based Sensors are embedded throughout the device to monitor cardiac flow rate, pressure, and temperature, while also providing physiological imaging of the surrounding vasculature. The sensors are connected to a control unit, which monitors and controls the pump parameters, providing real-time feedback, alarms, and tracking patient vitals during the during high-risk medical procedures.

[0023] The primary and secondary pumps can be operated either together or independently at adjustable speeds, depending on the need for cardiac or renal support. The device's expandable stabilizer is made from shape-memory alloys and features pneumatically actuated struts to secure the pumps in place during operation.

[0024] This double-pump device helps to manage critical conditions by stabilizing both cardiac and renal functions during cardiac or non-cardiac procedures.
BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 illustrates the double pump cardiac-renal assist device positioned within the depicted human heart.

[0026] Figure 2 illustrates the expandable stabilizer (201), designed to prevent the pump movement due to the axial thrust of the device during operation.

[0027] Figure 3 shows the expandable stabilizer made of shape memory alloy, having hollow cavities and configurations of 2, 3, 4, or 5 struts.

[0028] Figure 4 shows the atraumatic tip (401) designed in an umbrella shape, providing better support for the pump assemblies while preventing damage to the heart walls.

[0029] Figure 5 illustrates the positioning of the secondary pump assembly within the descending aorta during operation, with 501, 502, and 503 representing the arteries branching from the aorta to the upper part of the body, while 504 and 505 represents renal arteries.

[0030] Figure 6 illustrates the positioning of the secondary pump assembly, with the venturi cannula (1032) situated around the renal artery.

[0031] Figure 7 illustrates the venturi cannula (701) of the secondary pump assembly (102). The venturi cannula features holes (enlarged for visibility) labeled 702, which create a venturi effect that pulls fluid into the cannula, thereby reducing the pressure around the renal arteries and subsequently lowering renal perfusion, if needed, as per the clinicians evaluation.

[0032] Figure 8 illustrates the impeller (800) of the dual blood pump, which is equipped with grooves (802) that function as a centrifugal pump.

[0033] Figure 9 shows the squealer (901) at the tip of the blade in the impeller (800), designed to reduce leakage losses and shear stress, thereby enhancing hemocompatibility.

DETAILED DESCRIPTION OF THE INVENTION
[0034] The detailed description set forth below in connection with the appended drawings is intended as a description of various embodiments of the present invention and is not intended to represent the only embodiments in which the present invention may be practiced. Each embodiment described in this invention is provided merely as an example or illustration of the present invention, and should not necessarily be construed as preferred or advantageous over other embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the present invention.

[0035] A cardiac renal assist device as a bridge to high-risk medical procedures is disclosed by the present invention. High risk medical procedures may include cardiac or non-cardiac procedures. In some instances, a patient may be turned down by a doctor for a medical procedure due to falling under high-risk patient category. Such patients can be given a chance to be operated with the cardiac renal assist device support based on the risk analysis of the medical practitioner.

[0036] The present invention is designed to reduce heat generation and energy consumption in blood pumps by utilizing a double pump approach. This approach enhances the duration of support, reduces hemolysis, and provides cardiac assistance, while also altering renal function during medical procedures, all in a cost-effective manner.

[0037] The present invention discloses a double pump cardiac-renal assist device to maintain cardiac output and alter renal function during high-risk medical procedures, including both cardiac and non-cardiac interventions. This device serves as a vital support mechanism for patients deemed high-risk for certain medical procedures, allowing clinicians to assess and address individual patient needs effectively.

[0038] The double pump cardiac-renal assist device comprises a primary pump assembly (102) designed to assist the left ventricle in pumping blood to the aorta. This assembly includes an inlet (1022) for receiving blood from the left ventricle, an outlet (1024) for delivering blood to the aorta, and a motor-driven impeller (1025) to facilitate blood flow. An atraumatic tip (1021) at the inlet end provided to prevent damages to the heart walls.

[0039] A secondary pump assembly (103) is placed at the proximal end and is responsible for assisting renal perfusion by pumping blood from the descending aorta. The assembly is equipped with a venturi cannula (1033) with strategically placed holes (701, 702) near the renal arteries to alter the blood flow to the kidneys. The secondary pump also features an impeller (1035) driven by a motor for controlled blood movement.

[0040] The primary and secondary pump assemblies are connected via a shaft (104), which allows them to function in tandem or independently, based on the clinician's evaluation. The connecting shaft, ranges from 10 cm to 20 cm, is equipped with screws at both ends, enabling quick assembly or disassembly of the pumps, depending on whether cardiac or renal support is required. A catheter (105), length may range from 120-150cm, connects the device to an external control unit (101) that supplies power and manages the operation of the pumps. The control unit (101) monitors patient-specific parameters such as pressure, flow rate, and temperature through a series of embedded sensors placed along the pigtail, outflow connector and catheter.

[0041] The impellers in both pump assemblies can be expandable in diameter ranging from 3mm to 15mm, or can be fixed in diameter ranging from 3mm to 6mm, to enhance blood flow at lower RPMs, thereby reducing hemolysis. The blades on the impellers may be either rigid or expandable and are designed to minimize blood stagnation, thrombosis and leakage.

[0042] A stabilizer (201) made of shape-memory alloy is provided to maintain the device's stability during operation. This stabilizer expands once the device is in place, preventing movement due to the axial thrust produced by the pumps. The device also features sensors for monitoring critical parameters like pressure and temperature within the device and surrounding vasculature. The control unit regulates the pumps' operation based on real-time data received from these sensors.

[0043] The primary pump draws blood from the left ventricle and pumps it into the aorta, providing support for high-risk PCI procedures and cardiogenic shock by unloading the left ventricle. The secondary pump transfers blood from the distal end of the descending aorta to the proximal end, either just before or just after the renal arteries, thus regulating renal perfusion by increasing or decreasing blood flow to the kidneys.

[0044] Figure 1 illustrates a human heart alongside a double pump cardiac assist device. The control unit, 101, is positioned outside the body or worn as a portable shoulder-strap device. This unit provides power to the primary and secondary pumps, controls their operation, and monitors the patient's critical parameters either through wired connections or wirelessly via the Internet of Things (IoT) technology. Pump 102 represents the primary pump, while 103 is the secondary pump. The inlet of the primary pump, 1022, is located in the left ventricle and the primary pump includes an atraumatic tip, resembling a pigtail (1021), designed to prevent the inlet from damaging the heart walls. A cannula (1023) connects the inlet to the outlet and runs from the left ventricle to the aorta. This tube may be reinforced with shape memory alloys to make it of an expandable configuration. The outlet (1024), adjacent to or within the cannula itself, provides an oulet to facilitate blood outflow. It also acts as a protective shroud for the impeller (not shown), which rotates to pump blood from the left ventricle. The impeller is powered by a motor (1025), which can be magnetically or directly coupled, or integrated as part of the motor shaft. The impeller can be fabricated from biocompatible materials using standard methods such as 3D printing, CNC machining, or injection molding. Alternatively, the impeller can be connected via a flexible drive shaft to a motor located outside the body.

[0045] The secondary pump, labeled 103, is positioned in the descending aorta. Its components, including the inlet (1032), venturi cannula (1033), outlet (1034), and impeller coupled with motor (1035), are shown in Figure 1. The outlet of the secondary pump can be strategically placed either just above the renal arteries to enhance renal perfusion or just below the renal arteries to create a low-pressure zone, thereby reducing renal perfusion. A connecting shaft, 104, links the primary pump to the secondary pump. This shaft serves as a conduit for the motor and sensor wires and may also accommodate a flexible drive shaft.

[0046] Figure 2 shows the stabilizer 201 to hold the primary and secondary pump in place and prevent its displacement due to the axial thrust created by the pump. The stabilizer 201 is a shape memory which is expandable and having hollow cavities with 2,3,4,5 struts as shown in figure 3. Wherein the expandable stabilizer could be a membrane type actuated via pneumatic air or pneumatic fluid.

[0047] Figure 4 shows the atraumatic tip, 401 in an umbrella shape, is provided to support the primary pump assembly and prevent it from damaging the heart walls.

[0048] Figure 5 shows the placement of secondary pump in the descending aorta. Anyone experienced in the art can understand that the placement is not fixed claim and can be varied for multiple usages. 501, 502 and 503 are the arteries branching from aorta to upper part of the body. Secondary pump 103 can be placed such that the outlet is before the renal arteries 504 and 505. In such case, the renal perfusion will increase. The secondary pump can rotate with a different rpm as compared to the primary pump and both the pumps can be independently operated. Both the pumps can be synced at the same speed too using the controller. Both the pumps can be de-assembled to provide only single pump support as needed by the clinician.

[0049] Figure 6 shows the secondary pump is placed such that the venturi cannula, 1033, lies around the renal artery. In such case, the pressure exerted by the blood on renal artery will reduce and renal perfusion can be decreased. Thus, by controlling the position of the secondary pump, renal perfusion can be adjusted based on the clinician's evaluation and real time need.

[0050] Figure 7 shows the venturi cannula (1033, 701) of secondary pump, having holes (enlarged for visibility), 702, with a length of ranges from 5 cm to 15 cm, creating venturi effect and pulling fluid into the cannula thus reducing the pressure around renal arteries and in turn reducing the renal perfusion, if needed by the clinician.

[0051] Figure 8 shows the impeller, 800 of the double blood pumps. The end of the impeller is provided by grooves, 802, which acts as a centrifugal pump thus preventing blood stagnation at the back of impeller and improving hemodynamic performance of the pump. Design 802 can be incorporated in both the pumps or just one pump.

[0052] Figure 9 shows the squealer, 901 at the tip of the blade, in the impeller 900, to reduce the leakage losses and reducing the shear stress, by creating a mixing zone in the tip region thus improving hemocompatibility. The squealer can be a full or half type, either on primary pump, 102, or secondary pump, 103 or on both the pumps. Winglets (not shown) can also be used for the same.

[0053] In an embodiment, the cardiac-renal assist device incorporates both a primary and a secondary pump, which can be designed using diagonal, axial, centrifugal impellers, or combinations of these types. Each pump contains an impeller that is either directly connected to the motor or linked via a flexible shaft to the external motor in diameter ranging from 1mm to 4mm, allowing the impeller to rotate and pump blood through the device. At the distal end, the primary pump is configured to draw blood from the left ventricle and deliver it to the ascending aorta, thus unloading the left ventricle. Meanwhile, the secondary pump, located at the proximal end of the device, circulates blood to and from the descending aorta. This action reduces the afterload pressure exerted on the primary pump assisting the left ventricle, thereby decreasing power required by the first pump and thus the heat generation and reducing hemolysis from the primary pump. Both pumps can be operated independently, with different or identical speeds and flow rates. The impeller design for the primary and secondary pumps may be identical or varied, and can be axial, diagonal, centrifugal, or a combination of these types, depending on the specific requirements of the clinical application.

[0054] In another embodiment, the impeller of the cardiac-renal assist device comprises curved micro slots on its back surface, functioning as a centrifugal pump to prevent blood stagnation at the end of the impeller. Wherein the impellers of the device can be rigid or expandable. Expandable means that say impeller of 3mm diameter can be expanded to 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, once delivered inside. The expandable impeller can give higher flow rate at lower rpm's thus reducing homolysis. The impellers are equipped with squealers or winglets or both to reduce the leakage losses and hemolysis. Wherein one or both pumps can be designed as expandable types, having foldable blades with a hinge mechanism or self-expandable technology using shape memory alloys. In this case, the cannula would also be self-expandable and made from shape memory alloys.

[0055] In further embodiments, the double pump cardiac assist device includes one or more pressure sensors, either piezoelectric or optical based, temperature sensors, flow sensors and ultrasonic sensors, mounted on the atraumatic tip, inlet, outlets, multi-lumen catheter to measure the pressure or pressure difference, temperature of device and blood, cardiac flow rate and physiological image of the surrounding vasculature for patient monitoring. The position of the sensors can be changed as per the primary application. A series of ultrasonic sensors along the periphery and length is used to estimate the Pressure Volume Loop (PV loop) of the patient.

[0056] A purge fluid system is included to cool the drive unit and prevent blood from stagnating or entering the motor. The wires for the sensors, motor, and purge fluid system pass through a multi-lumen catheter that extends outside the body and connects to a control unit. This control unit manages the pump's operating parameters, monitors data from the sensors, triggers alarms when necessary, and tracks conventional patient vital signs.

[0057] The atraumatic tip at the proximal end of the device is designed in the shape of an umbrella to provide enhanced support to the pump assembly and prevent damage to the heart walls. The device may include 1 or more U-shaped atraumatic tips, as illustrated figure 4. The stiffness of the atraumatic may vary along its length, from the proximal end to the distal end, to optimize flexibility and support. Alternatively, the atraumatic tip can be replaced by a balloon-shaped end in other embodiments, offering different configurations for stabilizing the device within the heart.

[0058] The rate of change of renal perfusion, either increase or decrease, can be performed by varying the position of the secondary pump by placing the venturi cannula near the renal arteries. Where in the venturi type cannula with side holes are provided to reduce the renal perfusion. The holes of the venturi cannula can be round, square, trapezoidal or any other configuration.

[0059] The advantage of the invention is that the device's configuration allows for flexible operation, enabling the primary and secondary pumps to operate either at the same or different speeds or flow rates depending on the medical requirements. The design also allows the secondary pump assembly to be positioned above or below the renal arteries for optimal control over renal perfusion.

[0060] Further the device's configuration allows the primary and secondary pump assemblies are easily assembled or disassembled for independent or simultaneous use based on patient needs.

[0061] The double cardiac renal-assist device is useful during high-risk medical procedures requiring combined cardiac and renal support, ensuring better patient outcomes by reducing the workload on the heart and altering the renal function.

[0062] Some embodiments of this disclosure, illustrating all its features, will now be discussed in detail. The words "comprising," "having," "incorporating," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items.

[0063] It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0064] It should also be noted that in some alternative implementations in the description may occur out of the order noted in the drawings. Alternate implementations are included within the scope of the example embodiments in which functions may be executed out of order from that shown or discussed, including substantially concurrently or in reverse order, depending on the functionality involved.
, C , Claims:We Claim:
1. A double pump cardiac renal-assist device for maintaining cardiac output and altering renal perfusion of a patient during high-risk medical procedures, comprising:
a) a primary pump assembly (102) positioned at a distal end to pump blood out from left ventricle to aorta comprises;
an inlet (1022) for blood inflow from the left ventricle;
an outlet (1024) for blood outflow to the aorta;
a cannula (1023) connecting the inlet (1022) and outlet (1024) for blood passage;
an impeller coupled with a motor (1025) to pump the blood;
an atraumatic head (1021) provided at the end of inlet (1022) to prevent the inlet from damaging the heart walls;
b) a secondary pump assembly (103) positioned at a proximal end to pump blood from the distal end of descending aorta to the proximal end of descending aorta comprises;
an inlet (1032) for blood inflow from the distal end of descending aorta;
an outlet (1034) for blood outflow to the proximal end of descending aorta;
a venturi cannula with holes (1033, 701, 702) placed at renal arteries side;
an impeller coupled with a motor (1035) to pump the blood;
c) a connecting shaft (104) provided with screw at its both ends to link the primary pump assembly (102) to the secondary pump assembly (103);
d) an expandable stabilizer (201) provided to fix the primary pump (102) assembly and the secondary pump (103) assembly to keep the device stable and prevent movement caused by the device's axial thrust;
e) a control unit (101) positioned outside the body to provide power to the primary and secondary pumps (102, 103);
f) a catheter (105) connected to the control unit (101) linking to the secondary pump (103) comprises multiple lumens or hypo-tubes for delivering purge solution to the primary and secondary pumps (102, 103); and
g) series of sensors mounted on the atraumatic tip (1021), the inlets (1022, 1032), the outlets (1024, 1034), the cannula (1023), the venturi cannula (1033) and the catheter (105).

2. The double pump cardiac renal-assist device as claimed in claim 1, wherein the primary pump (102) and the secondary pump (103) are configured to be assembled or disassembled from the connecting shaft (104) to support the left ventricle or the renal artery perfusion, or to provide simultaneous cardiac and renal support.

3. The double pump cardiac renal-assist device as claimed in claim 2, wherein the primary pump (102) and the secondary pump (103) are configured to be assembled or disassembled from the connecting shaft (104) through the screws at both ends to enable standalone operation of either the primary pump assembly (102) or the secondary pump assembly (103) by directly connecting it to the catheter (105) depending on the need for cardiac or renal support.

4. The double pump cardiac renal-assist device as claimed in claim 1, wherein the primary and secondary pumps (102, 103) are operated either at the same or at different speeds or flow rates.

5. The double pump cardiac renal-assist device as claimed in claim 1, wherein the atraumatic tip (1021, 401) of the primary pump (102) assembly is in the form of an umbrella shape, or U-shape, or balloon-shaped end to prevent damage to the heart walls.

6. The double pump cardiac renal-assist device as claimed in claim 1, wherein the position of the secondary pump assembly (103) is variable, allowing the outlet of the secondary pump assembly to be positioned either upstream or downstream of the renal arteries or with the venturi cannula (1033, 701) of the secondary pump assembly positioned around the renal arteries, thereby enabling regulation of the rate of renal perfusion.

7. The double pump cardiac renal-assist device as claimed in claim 1, wherein holes of the venturi cannula (702) provided in the secondary pump assembly (103) is round or square or trapezoidal.
8. The double pump cardiac renal-assist device as claimed in claim 1, wherein the impellers coupled in the primary and secondary pump assemblies (102, 103) are axial or diagonal or centrifugal blades for preventing blood stagnation at the end of the impellers.

9. The double pump cardiac renal-assist device as claimed in claim 1, wherein the impellers coupled in the primary and secondary pump assemblies (102, 103) are made of biocompatible material and configured with:
squealers of varying cavity depths (901) which may be full or partial, and
winglets of differing widths to reduce tip leakage losses.

10. The double pump cardiac renal-assist device as claimed in claim 1, wherein the impellers coupled with motors (1025, 1035) in the primary and secondary pump assemblies (102, 103) are a combination of axial and centrifugal types in both pumps, or the primary pump can be axial while the secondary pump is having a combination of axial and centrifugal.

11. The double pump cardiac renal-assist device as claimed in claim 1, wherein the impellers coupled with motors (1025, 1035) comprise blades that is rigid or expandable.

12. The double pump cardiac renal-assist device as claimed in claim 14, wherein the impellers coupled with motors (1025, 1035) are expandable in diameter ranging from 3mm to 15mm after insertion into the body to get a higher flow rate at lower revolutions per minute (RPMs) to reduce hemolysis.

13. The double pump cardiac renal-assist device as claimed in claim 1, wherein the connecting shaft (104) is fixed to serve as a conduit for the motors (1025, 1035), wires of the sensors and flexible shaft.

14. The double pump cardiac renal-assist device as claimed in claim 1, wherein the expandable stabilizer (201) is made of a shape memory alloy and is a membrane-type having hollow cavities with struts actuated via pneumatic air delivered through one of the lumens of the catheter.

15. The double pump cardiac renal-assist device as claimed in claim 15, wherein the shape memory alloy is nitinol or pneumatic or fluid-based expansion.

16. The double pump cardiac renal-assist device as claimed in claim 1, wherein the control unit (104) is configured to:
provide power to the primary and the secondary pumps (102, 103),
control operation of the primary and secondary pumps (102, 103), and
monitor critical parameters of the patient.

17. The double pump cardiac renal-assist device as claimed in claim 1, wherein the sensors are configured to:
measure the pressure and pressure difference within the device and blood,
monitor the temperature of the device and blood,
determine the cardiac flow rate,
provide physiological imaging of surrounding vasculature for patient monitoring, and
estimate pressure volume loop of the patient.
wherein the sensors comprise flow-sensors, pressure sensors, temperature sensors, and ultrasonic sensors.

18. The double pump cardiac renal-assist device as claimed in claim 20, wherein the pressure sensors are selected from piezoelectric or optical based sensors.

19. The double pump cardiac renal-assist device as claimed in claim 20, wherein the ultrasonic sensors are placed on the atraumatic tip (1021) to estimate pressure volume loop of the patient.

20. The double pump cardiac renal-assist device as claimed in claim 1, wherein the multi-lumen catheter or hypo-tubes (105) connected to the control unit (101) is provided with wires for supplying power to the sensors and the motors (1025, 1035).

21. The double pump cardiac renal-assist device as claimed in claim 1, wherein the device is configured to reduce the afterload pressure on the primary pump assisting the left ventricle, thereby decreasing the power required by the first pump, minimizing heat generation, and reducing hemolysis during high-risk medical procedures, including both cardiac and non-cardiac interventions.

22. The double pump cardiac renal-assist device as claimed in claim 1, wherein the primary and secondary pump assemblies (102, 103) can be powered by larger external motors with enhanced torque capabilities through a flexible shaft of diameter ranging from 1mm to 4mm, made out of twisted biocompatible wires like nitinol, thereby providing an alternative to implantable motors and reducing blood stagnation, leakage losses, and hemolysis.

Documents