Paraaortic Blood Pump Device

Abstract

The para-aortic blood pump apparatus includes a blood pump, an aortic adapter, a drive catheter, and a driver. The blood pump includes a blood sac, a pump housing, and a pressure sensor mounted within the pump housing for monitoring blood pressure inside the blood pump. The aortic adapter is a T-catheter that connects to the blood pump and is used to connect the blood pump to the body's aorta to provide blood circulation support. The drive catheter transmits electronic blood pressure signals to the driver, and the drive catheter also allows pneumatic communication with the blood pump. The driver receives and processes the electronic blood pressure signals to determine the time, speed, and duration of the fill and ejection operations of the blood pump, thereby providing counter-pulsatile circulatory support to assist the body's blood circulation.

Description

[Technical field]

[0001] The present invention relates to a ventricular assist device (VAD), and in particular to a left ventricular assist device (LVAD) based on the principle of counterpulsation support. This application claims priority to U.S. Provisional Application No. 63 / 162,086 and U.S. Provisional Application No. 63 / 162,098, filed in the United States on March 17, 2021, the contents of which are incorporated herein by reference. [Background technology]

[0002] Mechanical circulatory support techniques in the treatment of heart failure.

[0003] The progression of heart failure is characterized by a vicious cycle. Drug therapy for early to moderate heart failure is a compensatory mechanism that suppresses neurohormonal production, and such drug therapy alleviates rather than cures the continuous deterioration of the vicious cycle of heart failure. Cardiac implants or ventricular assist device (VAD) implantation for heart failure therapy can only be applied to terminal stage heart failure. During the progression of heart failure, there is an interval of "unmet need" with no treatment between the ineffectiveness of drug therapy and cardiac implant / VAD therapy. After the deterioration of heart failure exceeds the effective drug therapy stage, patients can no longer receive any treatment and can only wait for heart failure to worsen further until the terminal stage when cardiac implant / VAD implantation can be considered. This treatment gap is classified as level 4-7 on the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) heart failure scale, and patients with this condition usually exhibit symptoms of apnea, renal insufficiency, exercise intolerance, and an increased systemic inflammatory response.

[0004] The optimal strategy for treating heart failure with mechanical circulatory support (MCS) is to timely implant a left ventricular assist device (LVAD) before heart failure becomes irreversible. However, this treatment strategy is not feasible in practice. Current turbo blood pumps (rotary pumps) and continuous-flow left ventricular assist devices (LVADs) are highly invasive during implantation and have a significant postoperative complication rate, so left ventricular assist devices are only applicable to patients with end-stage heart failure.

[0005] From the past 50 years of experience with bedside intra-aortic balloon pump (IABP), counterpulsation support therapy has been proven to be clinically effective. Recently, by implanting a balloon pump from the axillary artery or subclavian artery, the use of IABP has been extended from bedridden support to ground-based support, and patients have been successfully bridged to cardiac implantation. Balloon counterpulsation circulatory support and ground-based activity of patients have shown remarkable therapeutic effects in improving the functional status of the heart. However, the improvement effect of implantation site surgery is limited, patients still have to be hospitalized, and the time to support circulation is not long.

[0006] Currently, there are no clinically approved early intervention blood pump devices with partial support (blood pumps providing a pumping flow rate of 2-3 liters per minute), and such devices are particularly suitable for end-stage heart failure patients with milder conditions. The majority of such end-stage heart failure patients with milder conditions continue to deteriorate and develop acute myocardial ischemia and cardiogenic shock, requiring emergency mechanical circulatory support. Although acute circulatory support systems such as intra-aortic balloon pumps (IABP), extracorporeal membrane oxygenation (ECMO), and percutaneous micro-ECMO can be implemented to provide life support, the mortality rate of supported patients is generally in the range of approximately 40-70% higher. After the implementation of acute circulatory support devices becomes ineffective, patients, families, and clinicians usually have difficulty deciding whether to use turbo blood pumps, which are highly invasive and expensive. Therefore, developing a new long-term implantable ventricular assist device with an innovative design based on the concept of early intervention and minimal surgical trauma, and overcoming the traditional dead window in the treatment of heart failure, is a major challenge for related medical device manufacturers.

[0007] The early intervention portion is supported by a left ventricular assist device (LVAD). Summary of the Invention [Problem to be solved by the invention]

[0008] Based on the principle of counterpulsatile support, the present invention has invented an early intervention partial assist blood pump system, also called a para-aortic blood pump device. The para-aortic blood pump device of the present invention provides counterpulsatile circulatory support, which includes increasing systemic blood flow during diastole (heart expansion) to improve myocardial and organ perfusion while simultaneously reducing the left ventricular work load during systole (heart contraction). For implanted mechanical circulatory support devices, early hemodynamic support and postoperative walking ability are very important for survival and disease improvement. Minimally invasive surgery is the premise for performing early intervention, so in addition to the hemodynamic treatment that the left ventricular assist device can provide, minimally invasive surgery is another important factor. With the specially designed surgical instruments, the para-aortic blood pump device of the present invention can be implanted through a surgical procedure with small incisions (e.g., beating heart micro-left thoracotomy). Clinical evidence has shown that hearts supported by a left ventricular assist device can undergo reverse cellular remodeling after long-term systolic unloading treatment. This finding implies that providing early mechanically removed ambulation support is advantageous for bridge to recovery or remission treatment, especially in patients with milder disease (INTERMACS classification levels 4-7).

[0009] To date, approved long-term implantable left ventricular assist devices have primarily been continuous flow turbo blood pumps and have only been applied to patients with end-stage heart failure. There is a therapeutic gap between the stage of pharmacological ineffectiveness and final left ventricular assist device support or cardiac implant therapy. The para-aortic blood pump device of the present invention fills this therapeutic gap by offering a method of early intervention, partial support. The device can be implanted through a minimally invasive surgical procedure.

[0010] By developing a small paraaortic blood pump device before implanting a cardiac implant or a highly invasive turbo blood pump, patients can be provided with long-term circulatory support, which is a reasonable and useful treatment method for patients. By implementing therapeutic counterpulsation support and non-bedridden support for several months (1-2 years) or more, some patients may recover under circulatory support by the paraaortic blood pump device. For recipients who are hemodynamically stable but cannot recover from heart failure, the paraaortic blood pump device can be used as a destination therapy device or a bridge to implantation for a long period of time. Therefore, the paraaortic blood pump device can be selected as a temporary bridge therapy before cardiac implantation or expensive and invasive turbo blood pump implantation. Therefore, the role of the paraaortic blood pump device in heart failure treatment is diverse, and it can be used as a bridge to recovery (or palliation), a bridge to determine the treatment method (turbo blood pump), a bridge to cardiac implantation, or instead of cardiac implantation. Invention Contents

[0011] One of the main objectives of the present invention is to overcome the shortcomings of the prior art by disclosing a para-aortic blood pump device, which includes a blood pump, an aortic adapter, a driving catheter, and a driving unit. The blood pump includes a pump housing, a blood sac, and a pressure sensor, which is mounted in the pump housing of the blood pump and is used to monitor the blood pressure inside the blood pump. The detected blood pressure is converted into an electrical signal and sent to the driving unit through the driving catheter. The aortic adapter is a T-shaped catheter connected to the blood pump, which is used to connect the blood pump to the human aorta. The aortic adapter is thin-walled, and the aortic adapter can have a structural reinforcement design that fits around the catheters on both sides of the aortic adapter to enhance anti-buckling strength. The driving catheter is connected to the housing of the blood pump to provide air pressure pulses to the blood pump and transmit the electronic blood pressure signal received from the pressure sensor. The driving unit is connected to the pressure sensor and receives the electronic blood pressure signal. The actuator contains an EMA (Electro-mechanical actuator), and generates a pressure pulse command based on the electronic blood pressure signal detected by the controller in the actuator. The pressure pulse drives the catheter and is sent to the blood pump, which supports the circulation of the human body and completes the bleeding and congestion functions of the blood pump.

[0012] In some embodiments, the drive section further includes a drive catheter controller for processing the electronic blood pressure signal and a vibrator for providing an audio alert or tactile feedback.

[0013] In some embodiments, the drive catheter and part of the drive section are replaced with a distal driveline, a driveline interconnector, and a proximal drive catheter, the distal driveline for transmitting electronic blood pressure signals and air pressure pulses to the blood pump, and the drive catheter interconnector includes a drive catheter controller for processing the electronic blood pressure signals and a vibrator for providing audio alerts or tactile feedback.

[0014] In some embodiments, the blood pump is integral with the aortic adapter.

[0015] In some embodiments, the para-aortic blood pump apparatus further includes a coupler, and the coupler includes a coupling adapter attached to the neck of the aortic adapter, whereby the blood pump is coupled to the aortic adapter.

[0016] In some embodiments, the flared ends of the aortic adapter comprise a smooth transition in elastic properties, becoming gradually softer as the wall thickness profile of the aortic adapter catheter decreases.

[0017] In some embodiments, a blood sac is incorporated within the housing of the blood pump, the blood sac being an oval-shaped membrane body of revolution with the centerline of the blood pump as the center of rotation, and two polymeric stems are connected to the membrane body at both ends. When attached to the housing of the blood pump, the polymeric stems function as a flexing / stretching relief mechanism to reduce the stress concentration phenomenon when the membrane body deforms.

[0018] In some embodiments, the pump housing of the blood pump has an opening that is integrally molded with the aortic adapter to provide a seamless, smooth interface between the blood pump and the neck of the aortic adapter.

[0019] In some embodiments, the electromechanical actuator includes a pressure balance valve connected to a cylinder, the pressure balance valve periodically opening to balance the air pressure in the cylinder with atmospheric pressure.

[0020] In some embodiments, the para-aortic blood pump device provides a counter-pulsating gain in systemic blood flow during diastole (heart expansion) to improve myocardial and organ perfusion while simultaneously reducing the workload of the left ventricle during systole (heart contraction).

[0021] In some embodiments, the driver includes a trigger detection microcontroller unit, and the electronic blood pressure signal provides a detected pressure waveform within the blood pump, and the trigger detection microcontroller unit calculates and determines the exhaust and fill times of the cylinder of the electromechanical actuator.

[0022] In some embodiments, the electromechanical actuator includes a motor and ball screw unit that drives a piston in a cylinder, the reciprocating motion of the piston drawing in and ejecting air through a drive catheter that connects to a blood pump.

[0023] In some embodiments, the electromechanical actuator is an air actuator, which includes a brushless servo motor, a ball screw unit and a piston-cylinder assembly, which uses air as a driving medium to reciprocately inject and fill the air chamber of the blood pump, and a pressure balance valve is installed on the cylinder wall of the air actuator to solve the problems of gas leakage from the piston ring and condensation of water vapor exuded from the blood sac membrane.

[0024] In some embodiments, the driver receives an electronic blood pressure signal and processes the electronic blood pressure signal using a trigger detection algorithm to generate a trigger signal that activates the driver in conjunction with heart rate.

[0025] In some embodiments, after receiving a predetermined trigger time, the trigger detection microcontroller unit sends a command to a motor controller to drive a piston of an electromechanical actuator and provides counter pulsatile circulatory support including implementing contraction withdrawal during systole and perfusion gain during diastole by following the piston position from eject to fill or from fill to eject, respectively.

[0026] In some embodiments, the drive also includes a user interface module including indicators, sound alarms, buttons, and a liquid crystal display.

[0027] In some embodiments, when the trigger detection microcontroller unit loses the electronic blood pressure signal from the blood pump, the trigger detection microcontroller unit automatically activates a flushing mode and drives the electromechanical actuator to operate at a predetermined frequency and driving stroke amount to flush the blood sac and avoid the occurrence of blood clots.

[0028] In some embodiments, the flush mode is used to prevent blood clots from forming in the blood pump and is a device protection mode rather than providing circulatory support.

[0029] In some embodiments, the blood sac is secured to a proximal housing of the pump housing via a proximal port and secured to a distal housing of the pump housing via a remote port. [Brief description of the drawings]

[0030] [Figure 1] 1 is a schematic diagram of a para-aortic blood pump device according to a first embodiment of the present invention. [Diagram 2]FIG. 4 is a schematic diagram of a para-aortic blood pump device according to a second embodiment of the present invention. [Diagram 3] FIG. 11 is a schematic diagram of a para-aortic blood pump device according to a third embodiment of the present invention. [Figure 4] FIG. 11 is a schematic diagram of a para-aortic blood pump device according to a fourth embodiment of the present invention. [Diagram 5] 1 is a schematic diagram of a para-aortic blood pump device attached to a human body according to a first and second embodiment of the present invention. FIG. [Figure 6] FIG. 13 is a schematic diagram of a para-aortic blood pump device attached to a human body according to the third and fourth embodiments of the present invention. [Figure 7] FIG. 2 is a first schematic diagram of a drive unit according to the embodiment of the present invention. [Figure 8] FIG. 2 is a second schematic diagram of a drive unit according to an embodiment of the present invention. [Figure 9] FIG. 2 is a schematic diagram of the driver functions and major interconnect signals required for the operation of the present invention. [Figure 10] FIG. 13 is a schematic diagram of driver functions and major interconnect signals required for operation of the third embodiment of the present invention. [Figure 11] FIG. 11 is a schematic diagram of the main interconnection signals of the driver functions required for operation of the second embodiment of the present invention. [Figure 12] Figure 1 illustrates the electro-mechanical actuator (EMA) piston position trajectory and timing of trigger detection commands associated with the reverse pulsation cycle assistance. [Figure 13A] FIG. 1 is a perspective view of a para-aortic blood pump implant according to the first or third embodiment of the present invention. [Figure 13B] FIG. 2 is a cross-sectional view of a para-aortic blood pump implant according to the first or third embodiment of the present invention. [Figure 14A] FIG. 1 is a perspective view of a para-aortic blood pump implant according to the second or fourth embodiment of the present invention. [Figure 14B] FIG. 1 is a cross-sectional view of a para-aortic blood pump implant according to the second or fourth embodiment of the present invention. [Figure 15]Another embodiment of the present invention is a connection between a carrier and a pump housing of a blood pump, the connection of the carrier being made by an inlet on the remote housing. [Figure 16] FIG. 16 is a cross-sectional view of the blood pump shown in FIG. [Figure 17] FIG. 13 shows a shallow groove design for running electrical wires from an inlet in the remote housing to the pressure sensing chamber in the proximal housing. [Figure 18A] 1 shows the outer end of the blood pump using an interface adapter connector and connecting the opposing mating artery to the artery. [Figure 18B] 1 shows the coupling of the blood pump of the present invention to the artery via an insert type connection method using a T-shaped intravascular connector coupled via an interface adapter. [Figure 19] 1 shows a cross-sectional view of a body of revolution of a stem assembly including an integral axisymmetric elliptical blood sac and sac, a proximal stem and a distal stem. [Figure 20] Exploded view showing the components that make up the axisymmetric elliptical blood sac and stem assembly (Note, the sac is in its original shape prior to being joined and integrated to the proximal and distal stems shown in Figure 3) [Figure 21] FIG. 19 shows the structure of the bent trilobal pouch at the end of the blood pouch injection. [Figure 22] 1 shows a perspective view of a carrier connected to a proximal end housing of a blood pump via an introduction member. [Figure 23A] 23 shows a cross-sectional view of the distal end of the blood pump and carrier taken along section AA of FIG. 22. [Figure 23B] 23 shows a cross-sectional view of the proximal end of the carrier along section AA of FIG. 22. [Figure 24] FIG. 13 shows a cross-sectional view of an exhaust port attached to a proximal end housing according to the first embodiment. [Figure 25A] 1 shows a cross-sectional view of the pressure sensing chamber and introducer member in the proximal housing of the first embodiment. (Note: the carrier is not attached and the introducer includes a first portion, an extension of the proximal housing, and a second portion associated with the first portion.) [Figure 25B]FIG. 25B shows a perspective view of an integrated MEMS pressure sensor. [Figure 26] 1 shows a cross-sectional view of a multi-layer carrier of the present invention, including an inner tube for air transport, a middle tube for electrical signal transmission, a coil, a tether, and an outer tube. [Figure 27] FIG. 11 is a cross-sectional view showing a design proposal for a multi-chamber conveying material. [Figure 28A] 1 shows a typical diagram of the flow characteristics during the pump filling stage. [Figure 28B] FIG. 2 is a diagram showing a schematic flow characteristic of a pump discharge stage. [Figure 29] FIG. 2 is a perspective view of a T-shaped flow connector according to the present embodiment. [Diagram 30] FIG. 2 is a cross-sectional view of a T-shaped flow connector of the present embodiment. [Diagram 31] This is an expanded plan view of an inserted metal stent made of nickel-titanium alloy. [Diagram 32] Define the lateral stiffness (LS) of the insertion catheter to measure the nickel-titanium alloy metal stent and T-shaped flow connector. [Diagram 33] FIG. 2 is an exploded schematic diagram of the inside of the coupler and its components. [Figure 34A] FIG. 2 is a schematic diagram of a coupler in an open state (configuration). [Figure 34B] FIG. 2 is a schematic diagram of a coupler in a locked configuration. [Diagram 35] FIG. 2 is a cross-sectional schematic diagram of an aortic adapter and a para-aortic blood pump connected by a coupling. [Figure 36A] FIG. 1 is a schematic diagram showing step discontinuities caused by the docking method. [Figure 36B] FIG. 1 is a schematic diagram showing gap discontinuities caused by the docking method. [Figure 37] FIG. 1 is a schematic diagram of an inlet adapter for attachment to a remote location on an aortic bypass pump. [Figure 38] FIG. 4 is a cross-sectional view of the inlet adapter. [Figure 39]Illustrated is the downward tapered beak of the inlet adapter that connects to the angled (slanted) surface of the neck of the T-shaped flow connector. [Diagram 40] FIG. 13 is a schematic diagram of a crimp flow connector arranged to be wrapped with a tie (wrapped configuration). [Figure 41A] 1 shows an insert flow connector inserted through an access hole formed in the aortic wall. [Figure 41B] 1 shows the coiled flow connector fully inserted into the aortic lumen. [Figure 41C] 1 shows the compression style flow connector repositioned with its T-neck facing the aortic access hole. [Figure 41D] 1 shows the flow connector in an expanded, deployed form, with the T-neck popping out of the aortic access hole after the ties are released. [Diagram 42] FIG. 1 shows an illustration of the steps of implanting an aortic adapter into the aortic segment of interest and connecting it to a blood pump. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] The following provides four embodiments for realizing the para-aortic blood pump device of the present invention, as follows:

[0032] Please refer to FIG. 1. It is a schematic diagram of a para-aortic blood pump device according to a first embodiment of the present invention. The para-aortic blood pump device 10 includes a blood pump 12, an aortic adapter 14, a driving catheter 16, and a driving unit 18. The blood pump 12 further includes a pump housing and a pressure sensor. The inside of the pump housing is composed of two chambers, one for storing blood and the other for receiving driving air. The two chambers are separated by an egg-shaped flexible film, which is suspended and fixed by a pair of stress-relief stems connected to the pump housing. The pressure sensor is mounted in the pump housing of the blood pump 12 to monitor the blood pressure in the blood pump 12 and generate an electronic blood pressure signal. The aortic adapter 14 is a valveless, T-manifold shaped conduit-shaped flow manifold that connects the blood pump 12 to the human aorta. In the first embodiment, the aortic adapter 14 and the blood pump 12 are integrally molded to have a seamless blood contact surface, and the blood pump 12 is connected to the human aorta through the aortic adapter 14. The aortic adapter 14 is made of a flexible material and can be deformed when inserted into a circular hole formed in the aortic wall and transported. The aortic adapter 14 can expand and deploy by itself after the aorta is inserted, and has sufficient strength to withstand the radial compressive contact force of the aortic cavity applied to the adapter wall due to oversize fitting. The driving catheter 16 is connected to the housing of the blood pump 12 and supplies air pressure pulses to the blood pump 12 and transmits the blood pressure signal received from the pressure sensor. The driving unit 18 is connected to the driving catheter 16 to receive the transmitted electronic blood pressure signal, and the driving unit 18 includes an electromechanical actuator that generates air pressure pulses based on the electronic blood pressure signal, which is sent to the blood pump 12 through the driving catheter 16. The wearable actuator 18 provides a heart rhythm-linked air pressure pulse control law to drive the blood eject and fill of the implanted blood pump 12 .

[0033] The aforementioned drive unit 18 includes a battery power supply system 11 and a backup battery power supply system (same or similar to the battery power supply systems 21, 31, 41 in the following Figures 2 to 4 and Figure 8), among which the backup battery power supply system ensures a continuous power supply for the drive unit 18. When the patient does not need to move, the drive unit 18 can also be conveniently powered via an AC adapter. The device also includes a clinical monitor, not shown in Figures 2 to 4, which is connected to the drive unit 18 and can provide a user interface for the clinician to monitor the device, display diagnostic messages, and access drive unit parameters for initial startup setting of patient data and optimization of specific treatment operation mode settings.

[0034] 1 and 2 show two different designs of blood pumps 12, 22 systematically coupled to the same drive catheters 16, 26 and drive units 18, 28. FIG. 2 is a schematic diagram of a para-aortic blood pump device 20 according to a second embodiment of the present invention, which differs from the first embodiment of the present invention in that the para-aortic blood pump device 20 according to the second embodiment further includes a coupler 25 or coupling adapter. The blood pump 22 and the aortic adapter 24 of the second embodiment are not integrally molded, but are detachable, and a coupler 25 is provided for coupling the blood pump 22 to the aortic adapter 24. The coupler must be carefully designed to minimize discontinuities in the connection interface. During implantation of the device, the aortic adapter 24 is first fed into the aorta through a hole cut in the aortic wall. The device can be installed using a specially developed implantation tool to fit the coupler 25 around the T-neck of the aortic adapter 24 so that the blood pump 22 can be connected to the coupler 25. After the blood pump 22 is inserted into the thoracic cavity, the blood pump 22 and the aortic adapter 24 are tightly locked and integrated through the coupler 25. Such a detachable blood pump 22 and aortic adapter 24 design has advantages during and after the implantation procedure. During the implantation of the device, the detachable blood pump design makes it easier to implant the aortic adapter, because the surgical area is clearer and is not interfered with by the pump body. In addition, after the implantation procedure, if the pressure sensor fails or the blood sac ruptures and emergency surgical replacement is required, the blood pump can be removed and replaced. In this respect, the detachable blood pump design of the second embodiment is advantageous. The aortic adapter can be left in the aorta without being removed, which avoids the troublesome and dangerous redo surgery involved in removing the aortic adapter.

[0035] Please refer to Fig. 1 and Fig. 3. It is a schematic diagram of the para-aortic blood pump device 10, 30 of the first embodiment and the third embodiment of the present invention. The third embodiment is different from the first embodiment of the present invention in that the driving catheter 16 of the first embodiment is replaced by the distal driving catheter 37, the driving catheter interconnector 33, and the proximal driving catheter 39 of the driving catheter 36 of the third embodiment. The distal driving catheter 37 is connected to the driving catheter interconnector 33 so as to transmit the electronic blood pressure signal acquired from the pressure sensor and the air pressure pulse transmitted from the driving unit 38. In addition, the driving catheter controller and the vibrator (for alarm warning) built in the driving catheter interconnector 33 are originally built in the driving unit 18 of the first embodiment, so the driving unit 18 of the first embodiment has a driving catheter controller and a vibrator added (compare with the driving unit 38 of the third embodiment). The driving catheter controller is used to process the electronic blood pressure signal, and the vibrator is used to provide audio warning and tactile feedback. In other words, the mechanical power transmission of the blood pump, as well as the analog / digital signal conversion and alarm notification, realized by the driving catheter 16 and driving unit 18 in the first embodiment are basically the same as those realized by the distal driving catheter 37, driving catheter interconnector 33, and proximal driving catheter 39 in the third embodiment.

[0036] The first embodiment has a simpler drive catheter arrangement design, and also has an electronic signal processor installed in the drive section, which can minimize the risk of environmental contamination (water or moisture condensation) on pressure signal measurement related to the drive catheter interconnector 33 and air leakage at the joint. However, such long-type drive catheters are prone to contact damage such as abrasion, kinking, and cuts due to contact with foreign objects during daily activities. If there is significant damage to the drive catheter 16 of the first or second embodiment, both electronically and mechanically, it may be necessary to replace the blood pump through surgery. Considering the risk of redoing the surgery and the associated medical costs, this is highly undesirable. The third or fourth embodiment employs an intermediate connector (drive catheter interconnector) to reduce the disadvantages of blood pump replacement related to such drive catheter breakage. In general, the distal drive catheter 37 has a shorter length exposed outside the body, and the skin dressing or the cover of the patient's vest is better protected through the drive catheter interconnector 33. In the extreme case where the driving catheter is severely damaged and cannot be repaired, the proximal driving catheter 39, which is most likely to be damaged, can be easily replaced without resorting to surgery. Also, the third or fourth embodiment is not susceptible to electromagnetic interference because the analog-to-digital signal conversion has already been completed within the circuit of the driving catheter interconnector 33. In the third or fourth embodiment, the fidelity of the pressure signal can be better ensured because the digital signal transmission within the proximal driving catheter 39 is not sensitive to electromagnetic interference.

[0037] Please refer to Figures 3 and 4. These are schematic diagrams of para-aortic blood pump devices 30 and 40 according to the third and fourth embodiments of the present invention, respectively. The third embodiment differs from the fourth embodiment in that the aortic adapter 34 and the blood pump 32 of the third embodiment are integrally molded, but the blood pump 42 and the aortic adapter 44 of the fourth embodiment are removable. The fourth embodiment further includes the blood pump 22, the aortic adapter 24, and the coupler 25 of the second embodiment. The blood pump 42, the aortic adapter 44, and the coupling 45, which are the same in the embodiments, will not be described here. The distal driving catheter 47, the driving catheter interconnector 43, and the proximal driving catheter 49 included in the driving catheter 46 are similar to the distal driving catheter 37, the driving catheter interconnector 33, and the proximal driving catheter 39 of the driving catheter 36.

[0038] Please refer to FIG. 5. It is a schematic diagram of a para-aortic blood pump device installed in a human body according to an exemplary embodiment of the present invention. The para-aortic blood pump device 90 includes a blood pump 92, an aortic adapter 94, a drive catheter internal segment 991, a drive catheter external segment 993, and a drive unit 98. In another embodiment, the para-aortic blood pump device further includes a coupler. The part of the para-aortic blood pump device 90 implanted in the human body includes the blood pump 92, the aortic adapter 94, and the drive catheter internal segment 991. In another embodiment, the para-aortic blood pump device further includes a coupler. In a surgical procedure, the aortic adapter 94 is attached to the aorta 95 to create an exit site EX of the drive catheter at a suitable location on the human body surface. The external segment of the para-aortic blood pump device 90 includes the drive catheter external segment 993 and the drive unit 98. Across the exit site EX, a segment of the internal segment 991 of the actuation catheter is covered with fabric velour and used to promote subcutaneous tissue ingrowth and achieve infection control. The implanted velour is optimally placed 2-5 cm subcutaneously away from the exit site EX. The actuation unit 98 is a wearable or portable device.

[0039] Please refer to FIG. 6. It is a schematic diagram of a para-aortic blood pump device installed in a human body according to an exemplary embodiment of the present invention. The para-aortic blood pump device 90 includes a blood pump 92, an aortic adapter 94, a distal drive catheter 97 (including a drive catheter internal segment 971 and a drive catheter external segment 973 outside the human body), a drive catheter interconnector 93, a proximal drive catheter 99, and a drive section 98. In another embodiment, the para-aortic blood pump device 90 further includes a coupler. The part of the para-aortic blood pump device 90 implanted in the human body includes the blood pump 92, the aortic adapter 94, and the drive catheter internal segment 971. In another embodiment, the para-aortic blood pump device further includes a coupler. In a surgical procedure, the aortic adapter 94 is installed in the aorta 95 to create an exit site EX of the drive catheter at a suitable location on the human body epidermis. The portions of the para-aortic blood pump apparatus 90 that are located outside the human body include the drive catheter extracorporeal segment 973, the drive catheter interconnector 93, the proximal drive catheter 99, and the drive section 98. The exit site EX is the boundary of the drive catheter, and the distal drive catheter is divided into the drive catheter intracorporeal segment 971, which is covered with velvet for infection control, and the drive catheter extracorporeal segment 973. The drive section 98 is a wearable or portable device.

[0040] The embedded subsystem is described in more detail below.

[0041] Implantation is accomplished through a relatively small chest opening via a left thoracotomy using minimally invasive surgical (LIS) techniques. For example, a chest incision is made at the seventh rib gap as the main incision to allow implantation of the aortic adaptor and blood pump. Two other small incisions are made between the sixth and eighth ribs to introduce the proximal and distal aortic clamps. The site between the aortic clamps allows the aortic adaptor to be implanted through a hole in the aortic wall. The aortic adaptor is flexible and can be curled and reduced to a small delivery shape before implantation. Once implantation in the aorta is complete, the aortic adaptor automatically snaps back to its original shape and has a super tight fit with the lumen at the planned implant site. Therefore, the material of the aortic adaptor is important and should be flexible, but have sufficient radial strength to keep the wall of the implanted aortic adaptor circular and not cause wall buckling. Potential materials for the aortic adapter include silicone and polyurethane elastomers, and reinforced polymer structures or metal materials can be embedded to enhance structural strength.

[0042] Each aortic adapter and its functional requirements in the above embodiments are further described below.

[0043] Hemodynamically, the aortic adapter provides a blood flow connection between the blood pump and the systemic circulation of the human body. In addition to this function, the aortic adapter can also serve as a mechanical base to secure the blood pump to the aortic adapter. The structure of the aortic adapter must be resilient, yet anti-buckling, and strong enough to withstand the internal blood pressure and external contact forces that arise when the blood pump comes into contact with the surrounding lung tissue, and due to respiration and thoracic diaphragm movement.

[0044] The aortic adaptor 54 is embedded in the aorta, and the boundary between the two catheter ends (catheter end 545, catheter end 645) and the aortic lumen forms a host / graft interface in the bloodstream (see Figs. 13B and 14B). In order to minimize the discontinuity of the host / implant boundary morphologically and elastically, the two catheter ends (catheter end 545, catheter end 645) are arranged to have a flared inner surface contour and a continuously tapered wall thickness distribution. This design of the catheter ends minimizes the step at the boundary and incorporates the compliance matching effect required at the time of connection into the design of the aortic adaptor. Therefore, the possibility of thrombus formation at the boundary can be significantly reduced. This is because the rate of clot aggregation at the boundary is slower than the rate of natural thrombolysis provided by the human aortic endothelium. The gradually thinner catheter wall structure also makes the catheter ends (catheter end 545, catheter end 645) softer (conformable) and allows the catheter ends to expand and contract in response to pulse pressure, creating a dynamic sealing effect to prevent blood cells from becoming trapped in boundary gaps, which are the usual source of clot formation.

[0045] The drive units of the above embodiments will now be described in further detail.

[0046] 7 and 8 are perspective views of the right and left sides of the drive unit 78. The internal modules of this compact drive unit 78 include an electromechanical actuator (EMA), an electronic controller, a pair of main batteries, and a backup battery. The drive unit 78 also includes a user interface panel 73, a battery hatch 71, a drive catheter socket 75, an external power socket 77, and a pair of ventilation holes 79, as shown in FIGS. 7 and 8.

[0047] The user interface panel 73 of the drive 78 displays important messages during operation and warnings for device failures and aortic pressure status. If the main battery runs low, it can be replaced through the battery hatch 71. If the patient is lying in bed and has long-term power available from a wall-mounted outlet, a cable is used to power the drive 78 through a connection to an external power socket 77. A proximal drive catheter 99, one end of a drive catheter external segment 993, and a voltage sensor signal and air pressure pulse are connected to the drive 78 through the drive catheter socket 75. A pair of vents 79 are attached to the opposite side of the drive 78 to allow outside air to pass through the interior of the drive 78 for cooling purposes.

[0048] The drive 78 is externally coupled to a clinical monitor, allowing the clinical controller to collect and display real-time clinical waveform data and store patient data for long-term condition monitoring and diagnosis. The clinical monitor unit can also provide a user interface for the clinician-patient, displaying device monitoring / diagnostic information and using it to set drive parameters, and initially activate the drive 78 to optimize and set the patient-specific personal circulatory support operating mode.

[0049] In the present embodiment, the EMA is an air actuator, which includes a brushless servo motor, a ball screw unit, and a piston-cylinder assembly. Air is used as the driving medium to reciprocate the blood pump to achieve the functions of ejection and blood pump filling.

[0050] The air actuator device is located in the drive unit and is carried by the person receiving treatment with the device. The electromechanical actuator includes a brushless servo motor, a piston and cylinder assembly, and a ball screw unit. The ball screw unit includes a ball screw post and a ball nut. The piston is fixed to the end of the ball screw post, and the rotation of the nut causes the screw post to move linearly back and forth. The servo motor includes a rotor and a stator, and the rotor and the ball nut are integrated. Through the electromagnetic induction action of the motor, the rotor rotates, and the screw post and the piston achieve linear reciprocating stroke motion in the cylinder through clockwise and counterclockwise direction changes. The piston stroke sends the air in the drive cylinder to the blood pump through the drive lead wire, completing the bleeding and filling action of the blood sac.

[0051] Using air as a medium to drive a blood pump faces two problems: one is the problem of gas leakage, and the other is the problem of water condensation caused by blood permeating the blood sac wall. The former impairs the blood pump's blood injection and congestion performance and the power consumption of the motor, while the latter causes the risk of bacteria being generated inside the driving cord due to moisture. In order to solve these two problems, the air actuator of this ventricular assist device is specially equipped with a pressure balance valve device on the cylinder wall. This valve allows the air mass formed by the air in the cylinder and the atmosphere to communicate with each other and to circulate with each other during the air pressure balance process. The air actuator is equipped with a position and optical sensor that allows the controller to obtain the position information of the piston, issue a piston drive command from the controller to drive the reciprocating motion of the piston, and operate the pressure balance valve. Therefore, the timing and frequency of opening the pressure balance valve can be programmed and stored in the controller. By the operation of this pressure balance valve, the air in the cylinder is exchanged with the outside air, achieving the function of air supply and dry gas, and further ensuring the operational safety and performance of this ventricular assist device.

[0052] Refer to FIG. 9. The para-aortic blood pump device according to the embodiment of the present invention is divided into three parts. The first part is mainly installed inside the human body, i.e., implanted, and its outer end communicates with the second part. The first part includes a blood pump (including a blood pump pressure sensor), an aortic adapter, and a distal driving catheter segment, which are respectively implanted in the human body. The second part is installed outside the human body and includes a proximal driving catheter and a driving catheter electronic module (or also called a driving catheter interconnector). The third part is a driving part installed outside the human body, which includes an electromechanical actuator (EMA), a controller circuit, a main battery, and a backup battery.

[0053] The blood pump pressure sensor is built into the proximal blood pump housing and immersed in a small pressure sensor chamber filled with a sensing medium, which can continuously monitor the blood pump pressure. The remote driving catheter is connected to the pump housing and supplies counter-pulsating air pressure pulses to perform dynamic ejection and blood sac filling. The distal and proximal driving catheters supply the blood pump with air pressure driving pulses generated by the EMA inside the actuator. The electronic blood pressure signal generated by the pressure sensor of the sphygmomanometer is sent to the driving unit. The driving air circuit (shown by the dashed arrow) and the communication signal path (shown by the solid line) are shown in Figure 9 to explain the functional relationship between the interactive actuation modules. The details of the aortic adapter have already been mentioned. The controller circuit includes a motor controller unit to drive the brushless motor and a microcontroller unit as a central processing unit, which can process the received pressure signal and generate control commands for the motor controller so that the piston works.

[0054] With reference to Figures 10 and 11, a schematic block diagram of the internal functions of the drive unit and the important interconnection signals required for the activation of the blood pump are shown. A further description of the proposed embodiment of the present invention is shown in Figures 10 and 11. With reference to Figures 10 and 11, in order to explain the drive relationship between the external drive unit and the implant, it is necessary to refer to the contents of the blood pump, drive catheter, distal drive catheter, proximal drive catheter, aortic adaptor and drive catheter interconnect described above.

[0055] The drive receives the blood pump pressure signal (electrical signal), processes the signal using a trigger detection algorithm, and generates a trigger signal that cooperates with the heart rate to command the motor actuator to operate. After receiving the designated trigger time, the microcontroller unit sends a command to the motor controller (unit) to drive the piston and provide reverse pulsation cycle support during the injection-to-fill or fill-to-inject process.

[0056] The electronic controller architecture consists of three functional blocks: a microcontroller unit (MCU), a motor controller block (or motor controller unit), and a power management unit. The following table provides an overview of each functional block of the drive 78: TIFF0007623741000001.tif166138

[0057] 10 and 11, the exemplary embodiment disclosed above illustrates signal collection, transmission, processing, and generation of control logic and instructions, and how the electromechanical actuator operates to generate air pressure pulses to drive the blood pump.

[0058] FIG. 12 shows the trigger detection command of the electromechanical actuator piston position related to counterpulsation assist. In FIG. 12, the aortic pressure (AoP) waveform without assistance is shown in dotted line, and the aortic pressure waveform with assistance is shown in solid line. When the drive is operating in automatic operation mode, the drive operation is activated and the system executes a “fill-inject-fill-inject…” cycle assist. This represents a normal synchronous counterpulsation assist operation. The MCU monitors the blood pump pressure (BPP) signal (electrical signal) and detects the timing of left ventricular end diastole (LVED). Upon detecting the LVED timing, the MCU generates an F_Trig signal. The time interval between two consecutive F_Trig signals represents the instantaneous cardiac cycle interval (or period). Based on the estimated cardiac rate calculated from the interval of several cycles going forward, the MCU determines the blood pump ejection time, i.e., the E_Trig signal. The E_Trig signal provides the timing that commands the motor controller unit to drive the electromechanical actuator based on a predefined position, velocity, and acceleration curve. Once the ejection stroke is complete and the optimal dwell time has elapsed, the electromechanical actuator is commanded to perform a prefill operation at a slow fill velocity until the F_Trig signal is received. After receiving the F_Trig signal, the electromechanical actuator begins to perform the remainder of the fill stroke at the specified piston velocity.

[0059] If the MCU loses the BPP signal (electrical signal) sent from the blood pump, the MCU automatically activates the flushing mode to drive the electromechanical actuator and operate at the predetermined auxiliary frequency and volume pacing amount of the driver. The flushing mode is an equipment protection mode to prevent clot formation in the blood sac without providing synchronous counterpulsation circulatory support.

[0060] In principle, the para-aortic blood pump device of the present invention has a better counterpulsation support effect than intra-aortic balloon pump (IABP) due to the feature of non-occlusive aortic placement. Unlike bedridden or ambulatory IABP patients who have to stay in hospital, the para-aortic blood pump device of the present invention allows patients to leave the hospital and live a better life at home. Therefore, the para-aortic blood pump device of the present invention can obtain economic benefits from a shorter hospital stay, as well as further improve the disease status and quality of life of patients.

[0061] In recent years, the trend of LVAD use has been saturated, mainly because its application has only been applied to a small group of patients with end-stage heart failure. The application of early intervention LVAD therapy to patients with mild heart failure has long been a clinical goal of cardiac medicine. If early intervention therapy is possible, it is expected that this will have a significant impact on the expanded use of LVAD therapy and influence the future progress of cardiac medicine. Clinical evidence shows that providing LVAD support at the moderate to severe heart failure stage can improve some patients with non-ischemic cardiomyopathy by improving cardiac function through reverse remodeling of cardiomyocytes and causing sustained myocardial recovery. However, such early intervention intention must rely on two favorable driving factors: a simple and safe surgical procedure and an effective adaptive circulatory support treatment plan as the disease progresses. Continuous VAD support is non-physiologic and takes the supported heart off the normal path of health recovery. However, counterpulsation support is physiological and provides systolic contraction relief and diastolic perfusion gain to promote reverse remodeling of myocardial tissue and achieve therapeutic goals. In conclusion, the therapeutic strategy provided by this para-aortic blood pump invention meets the evolving conditions of early intervention trends in cardiac medicine. The beneficial attributes of therapeutic efficacy provided by the para-aortic blood pump device, such as adaptive partial-support, minimally invasive surgery, and counterpulsation therapy, make this invention a potential candidate to help advance the treatment of heart failure in the future.

[0062] The blood pumps of the above embodiments will be further described below.

[0063] 13A and 13B are schematic and cross-sectional views of a para-aortic blood pump device installed in a human body, which are the first and third embodiments of the present invention, respectively. The implanted subsystem of the para-aortic blood pump device includes a blood pump 52, an aortic adaptor 54, and a driving catheter (or a distal driving catheter) 57 connected to the blood pump 52. The blood pump 52 includes a rigid or semi-rigid housing 52h and a blood sac 529, the proximal end of which is closed and the distal end of which is open, and is seamlessly coupled to the aortic adaptor 54. Among them, the blood sac 529 is composed of an utricle membrane 526, and the blood sac 529 is fixed to the proximal end housing 523 of the housing 52h through a proximal end port 530, and is fixed to the distal housing 525 of the rigid housing 52h through a distal port 540. Within the housing of the blood pump 52, a blood chamber B and an air chamber A are partitioned by an egg-shaped flexible membrane 526, which is suspended from the rigid housing 52h via a pair of stress-relief stems (proximal end port 530, remote port 540). The blood chamber B is for storing blood, and the air chamber A is for receiving driving air. A pressure-sensing mechanism 527 (or blood pressure sensor) is hermetically fitted into the proximal end housing 523 of the rigid housing 52h, and the detected pump pressure is transmitted through the membrane 526, propagated through the incompressible liquid or gel contained in the sealed pressure-sensing chamber 528, and finally received by the pressure-sensing mechanism 527. After receiving the detected blood pump pressure, the pressure-sensing mechanism 527 generates an electronic blood pressure signal. The size and shape of the implantable subsystem assembly are designed to be implantable and applied to patients with a body surface area (BSA) of 1.2 square meters or more.

[0064] 14A and 14B are schematic and cross-sectional views of a portion of a para-aortic blood pump device attached to a human body according to a second and fourth embodiment of the present invention, respectively. The implantation subsystem of the para-aortic blood pump device includes a blood pump 62, an aortic adapter 64, a coupler 65, and a driving catheter (or a distal driving catheter) 67 connected to the blood pump 62. The coupling 65 is for connecting the blood pump 62 to the aortic adapter 64 to enter the vascular system of the person who will implant the device. The blood pump 62 includes a rigid housing 62h, which further includes a proximal housing 623 and a distal housing 625. The structure of the blood pump 62 is similar to that shown in FIG. 14B, except that the opening OP is separate and independent from the aortic adapter 64. The coupler 65 is placed around the neck 643 of the aortic adapter 64. Hereinafter, the design and basic design principle of the blood pump will be further described using the design disclosed in FIG. 14B.

[0065] 13B. The blood pump 52 includes a molded rigid housing 52h, which further includes a proximal housing 523 and a distal housing 525. The rigid housing 52h has a single opening OP connected to the aortic adapter 54 and enters the patient's vascular system. The opening OP of the blood pump 52 is seamlessly manufactured with the aortic adapter 54, providing a smooth and continuous boundary transition to the neck of the aortic adapter 54. The joining of such an integrated blood sac 529 and aortic adapter 54 assembly to the blood pump 52 connects the proximal housing 523 and the remote housing 525 by bonding the proximal port 530 and the remote port 540, respectively. The blood sac 529 is fixed to the top of the proximal housing 523 such that the non-flexible disc portion is bonded to the central pressure sensing chamber 528 of the proximal housing 523.

[0066] A miniaturized pressure sensing mechanism 527 is housed within the proximal housing 523 and is in fluid communication with a closed pressure sensing chamber 528. This device allows for continuous monitoring of blood pressure in a blood sac 529. Because the pressure sensing mechanism 527 does not come into contact with blood, the protection of the rigid housing 52h ensures long-term sensor reliability and fidelity, as the rigid housing 52h helps to insulate the pressure sensing mechanism 527 and its circuitry from the effects of chemical corrosion and protein adhesion due to direct blood contact.

[0067] The end of the actuation catheter 57 connects to the remote housing 525, which provides a counterpulsation dynamic pressure pulse for ejecting or injecting blood from the blood pump 52. The actuation catheter design can be multi-cavity or multi-layered to encase the wires used for transmitting the pressure signal. The kink resistance of the distal actuation catheter 57 can be improved by adopting a metal coil or a woven net or net as the catheter wall reinforcement member. The overall geometry of the flow path in this blood pump is relatively wide, and the valveless aortic adaptor design and the operation of the pulsatile blood pump constitute excellent blood processing characteristics, and avoid hemolysis due to high shear force and thromboembolism due to low flow rate.

[0068] Due to the innovative design of the blood pump 52 and blood sac 529 mentioned above, the sac membrane 526 is very durable. The blood sac 529 is an egg-shaped membrane rotating body with the center of rotation on the centerline of the blood pump 52, and two polymer ports (proximal end port 530, remote port 540) are bonded to both ends of the rigid housing 52h, which are configured in a disk shape or annular shape, respectively, and when connected to the rigid housing 52h, they reduce stress concentration as a bending / tensile stress release mechanism. During the process of injecting blood from the blood pump, the sac membrane 526 is compressed or folded into a tri-lobe shape, in which the maximum strain usually occurs at the fold near the edge of the port (proximal end port 530, remote port 540). Such local high membrane stress / strain caused by large deformation of the film is absorbed / counterbalanced by the flexible suspension deformation of the port edge. It is particularly noteworthy that the position of the tri-lobe folding mode is not fixed, the deformation of the film is affected by the gravity direction, and the fold position occurs randomly. In fact, the patient's body posture and orientation may change from time to time during daily activities, including standing, lying, sitting, and exercising. Therefore, the gravitational effect acting on the volume of blood stored in the blood pump 52 constantly changes direction, resulting in the formation of non-fixed creases. This randomly formed thin film crease characteristic constitutes the unique fatigue resistance characteristic of the present invention. The present blood pump 52 is expected to have a longer durability than conventional fixed folded yarn film designs.

[0069] The folding and expansion of the sac membrane is closely related to the vortex structure mode contained in the blood sac 529. The characteristic of the design of the blood sac described above is that the folding lines are randomly formed, and the vortex structure characteristics occur alternately with the change in the pattern of the folded membrane. Therefore, the cleaning effect in the blood pump 52 is strong, unsteady, and characterized by random wandering vortex motion. Such randomness of the blood pump vortex structure helps to wash the blood contact surface of the entire blood sac without generating fixed low-speed reflux areas near the membrane wall and in the fold area. In animal experiments, it was observed that the blood pump of the present invention has a very strong anti-thrombotic ability.

[0070] Each distal drive catheter in each embodiment is further described below.

[0071] Please refer to Figures 5 and 6. It is a schematic diagram of the driving catheter 96 connecting the blood pump 92 and the driving unit 98. The telemetry driving catheter 97 (driving the catheter body 991) which drives the catheter 96 connects the blood pump 92 to the electromechanical actuator housed in the driving unit 98 by air and transmits the electrical signal obtained from the blood pump pressure sensor mechanism 527 (see Figure 13). One end of the telemetry driving catheter 97 (driving catheter internal body segment 991) is connected to the blood pump housing, and the other end has a small external connector for air transmission and electrical communication. The telemetry driving catheter 97 (driving catheter internal body segment 991) exits from the skin through the subcutaneous passage under the protection of a protective cap. The outer diameter of the telemetry driving catheter 97 (driving catheter internal body segment 991) is designed to be small, and the tube material is radial, which minimizes the stress at the exit site EX and provides comfort to the patient. A portion of the telemetered actuation catheter 97 (actuation catheter internal segment 991) is covered with a porous fabric to promote tissue growth into the fabric and make the exit site EX infectious. The actuation catheter external segment 973, exiting the epidermis, is fixed a short distance away from the skin exit site EX.

[0072] The actuating catheter internal segment 991 and the actuating catheter external segment 993 and their connectors are designed to be sufficiently durable to withstand the tensile loads imposed during percutaneous surgery. After surgery, the actuating catheter internal segment 991 and the actuating catheter external segment 993 continue to be subjected to loads due to muscle movement, and the actuating catheter internal segment 991 and the actuating catheter external segment 993 are designed to withstand these fatigue loads. The exterior of the actuating catheter internal segment 991 and the actuating catheter external segment 993 are designed to be biocompatible and chemically resistant to cleaning agents and disinfectants during clinical use.

[0073] The proximal drive catheters of each of the above embodiments will now be described in further detail.

[0074] The driving catheter external segment 993 and the proximal driving catheter 99 are for connecting the driving catheter internal segment 991 and the distal driving catheter 97 to the driving section 98, respectively. The near driving section catheter 99 has a driving catheter interconnector 93 at one end and a driving section connector at the other end. The driving catheter interconnector 93 includes a circuit board that converts analog blood pump pressure signals to digital signals and a vibrator that provides tactile feedback in addition to the audio alarm. The driving catheter interconnector 93 has a flat shape to prevent the driving catheter external segment 973 from twisting when secured to the patient's skin. In addition, the driving catheter interconnector 93 and the driving catheter embedded wire are sealed and designed to prevent the ingress of water and moisture. The proximal driving catheter 99 is attached externally to allow replacement and maintenance when deemed necessary, so that if the proximal driving catheter 99 is damaged beyond repair, surgical replacement of the blood pump is not required.

[0075] Valveless blood pumps have two advantages in terms of blood processing characteristics. 1) There is no unpleasant valve sound and valve-induced blood cell disorder, thrombus formation and thromboembolism. 2) They have stronger antithrombogenicity. Bidirectional pulsating flow has a better surface cleaning effect, so that it can minimize protein adhesion and avoid the formation of blood clots associated with boundary discontinuities on artificial surfaces in contact with blood. The flow paths of pumps without valve pulsation are much more uniformly wide than those of valve pulsating or continuous flow rotary pumps. Hemolysis (red cell membrane rupture) usually occurs in narrow flow paths with high flow rate gradients, such as the gap between the valve annulus and leaflet of valved pulsating pumps. In addition, there are often low-speed recirculation and stagnation areas behind the open valve, which may promote the occurrence of thrombus. In contrast, in a nonvalvular pulsatile blood pump, the shear stress on blood cells is actually several orders of magnitude lower, the slow stagnation zones associated with valve geometry and motion are nearly eliminated, blood cell damage and platelet activation are reduced, clot formation and aggregation are reduced, and lower doses of anticoagulants can be used, resulting in easier and safer postoperative care.

[0076] 15-17 show schematic diagrams of a blood pump 62, a drive catheter 67, and an introduction member 63 according to another embodiment of the present invention. In this embodiment, an emphasis is placed on anatomical adaptability to facilitate easier externalization of the blood pump and delivery.

[0077] As shown in Figures 15 and 16, the drive catheter 67 is connected to the remote housing 625 of the blood pump 62. The blood pump 62 has an elliptical blood sac and stem assembly 659 (including sac 629 and stems 630, 640), a pump housing 62h (proximal end housing 623 and remote housing 625 with inlet connector 6251), and a pressure sensing system 628 fitted to the proximal end housing 623. The aforementioned components, inlet connector 6251, pressure sensing system 628, and drive catheter 67 are essentially the same or correspond to the assemblies / assemblies of the previously described embodiments, and a detailed description of these assemblies and their functions will not be repeated here.

[0078] In this embodiment, the remote housing 625 of the pump housing 62h is provided with an introduction member 63, which connects the driving catheter 67 to the pump housing 62h. The introduction member 63 is also configured in a body shape adjacent to the remote housing 625, and tangentially connects the power transmission member to the outer surface of the pump. With such a through-body design, the design of the pump housing 62h is adapted to the anatomical space available for the installation of the blood pump. The blood pump 62 is rotatably connected to the interface adapter 501, and the driving catheter 67 can be wired in an optimal direction to smoothly perform the subcutaneous tunnel and the skin exit. This is advantageous for anatomical adaptability to various shapes of the implant site.

[0079] In this embodiment, the introduction member 63 is remotely fitted into the remote housing 625, and the sensor 6271 (FIG. 25A) and the pressure sensing chamber 628 are disposed within the proximal end housing 623, thereby isolating the signal transmission path from the air pressure communication path, and it is necessary to seal and protect the blood pump 62, as the ingress of biochemical fluids may compromise the fidelity of signal transmission after the device is implanted.

[0080] See Fig. 17. The pump housing 62h has a groove 621 formed on the outer surface of the remote housing 625, located above the overlapping joint area da (Fig. 16) of the proximal end housing 623 and the remote housing 625. The surface groove 621 is arranged so that an electric wire extends from the outlet of the inlet 63, and the electric wire reaches the electrode 6274 in the second space 6273 (Fig. 25B) along the surface groove 621 above the overlapping joint area DA. In some embodiments, the groove 621 is sealed by potting a waterproof material and / or an annular cap so as not to irritate or injure the tissue that it contacts.

[0081] As shown in FIG. 18A and FIG. 18AB, the aortic connector 50 is a connection mechanism typically used to connect a blood pump 62 to a target artery 60 via its interface adapter 501. The distal end 504 of the connector 50 opposite the interface adapter 501 is placed on the vessel wall of the artery 60 and connected to the body circulating fluid. The proximal end of the aortic connector 50 (or interface adapter 501) has a smooth interface transition to geometrically match the inlet configuration of the blood pump 62. A coupler is typically required to integrate the proximal end of the connector 50 (or interface adapter 501) with the inlet of the blood pump 62. In some embodiments, the aortic connector 50 can be used. FIG. 18A shows an end-to-side mating of a Dacron or PTFE graft 502 sutured with a target artery (or blood vessel) 60, which can be used in vascular surgery. In some other embodiments, such as the embodiment shown in FIG. 18B, an insertable aortic connector 503 is used, such as a T-manifold adapter as disclosed in U.S. Patent Application No. US 2008 / 0300447A1, entitled “Dual-pulsation bi-Ventricular Assist Device.”

[0082] 19 and 20 respectively show a longitudinally symmetrical elliptical blood sac and stem assembly 650 and its components. Polymeric materials for these components include, but are not limited to, segmented polyurethanes of various suitable hardnesses. The components of the sac and stem assembly 650 include a flexible membrane sac (blood sac) 629, a proximal stem 630, and a distal stem 640, all of which, in some embodiments, are integrally formed in an axisymmetric shape about a common centerline 62C of the blood pump 62. The proximal stem 630 is located at the proximal end 6291 of the blood sac 629, and the distal stem 640 is located at the distal end 6292 of the blood sac 629.

[0083] FIG. 19 shows an integrated blood sac and stem assembly 650, with the end of the remote stem 640 wrapped around the remote of the blood sac 629 and connected to the inverted membrane 62A. FIG. 20 shows the components before connection. Typically, the blood sac 629 is manufactured by dip molding, and the stems 630, 640 are manufactured by injection molding. There is no preferred azimuth angle for the deflection sac deformation. Theoretically, as shown in FIG. 21, when the pressure difference on the membrane sac exceeds a certain threshold, the thin-walled sac with an axisymmetric elliptical structure will bend into a tri-valve shape 6293, and the bending of this membrane is related only to the final tri-valve shape 6293 (eigenmode), and the position of the fold 6294 or turn-back line that occurs there is determined by the initial disturbance that causes the bending instability. The uniformity of the thickness in the cross section cut by the center line (or axis of rotation) 62C of the assembly 650 perpendicular to the blood pump 62 is important. Care must be taken to manufacture the sac with high precision to ensure the axisymmetric shape. In real life, the direction of gravity is the primary factor in the initiation of folds. The posture of the recipient of the equipment constantly changes due to the patient's daily activities (e.g., standing, sitting, exercising, sleeping, etc.), and the direction of gravity relative to the blood pump direction also constantly changes. Therefore, the deformed folds 6294 of the sac appear in a random state, and the high strain folds are non-stationarily distributed throughout the sac. Therefore, avoiding leaving high strain areas in fixed positions is an important design criterion for the sac to have a long life.

[0084] The present embodiment innovates a traveling fold line characteristic that causes high strain locations to appear in the membrane in a non-stationary manner to increase the fatigue life of the membrane sac. Thus, the detrimental stress concentration phenomenon often associated with a flexed blood sac is improved. Based on the inherent change in the behavior of this flex mode, the fatigue life of the membrane is significantly increased due to this non-stationary fold line formation characteristic, which distributes high strain areas throughout the sac. The beneficial results associated with this non-stationary sac deformation mode also depend on the enhanced vortex washing effect in the blood sac. The surface of the sac is washed more thoroughly, and irregular walking-like vortices are formed and traverse the entire vortex flow. This significantly reduces the possibility of constant low-velocity recirculation areas and fold line creases in the near-wall region, resulting in a long-life and anti-thrombogenic blood pump design.

[0085] 22, 23A and 23B show an exemplary embodiment of how the integration method can be employed to attach the blood sac and stem assembly 650 to the pump housing 62h and connect the drive catheter 67 to the proximal end housing 623.

[0086] The blood sac 629 is fixed to the pump housing 62h, which includes a proximal end housing 623 and a remote housing 625, to facilitate the filling and discharging action of the pump. Generally, the flexure characteristics of the blood sac 629 and the pump housing 62h are significantly different. To complete the design of the blood sac for long-term use, it is necessary to install an intermediate suspension so that the pump assembly is continuous in the transition of structural characteristics (especially the bending deformation of the membrane). A pair of flexible stems (proximal end stem 630 and remote stem 640) are used as a suspension mechanism that integrates the blood sac 629 and the pump housing 62h. As shown in FIG. 23A, the proximal end stem 630, which is disk-shaped, is connected to the proximal end housing 623, and the remote stem 640, which is ring-shaped, is connected to the remote housing 625. Mechanically, the proximal and distal stems 630, 640 not only retain the blood sac 629 within the pump housing 62h, but also act as a stress relieving suspension mechanism to avoid stress concentrations at the interface attachment points and extend the life of the blood sac 629.

[0087] As shown in the lower part of FIG. 23A, the remote housing 625 includes an extension of the inlet connector 6251, which is mated with the aortic connector 14. The inlet connector 6251 has a first end 6252 attached to the blood sac 629 and a second end 6253 shaped like a beak, which is mated with the interface adapter 501 (shown in FIGS. 18A, 18B). The first end 6252 of the inlet connector 6251 mates smoothly with the remote of the blood sac 629. However, the opposing second end 6253 is configured to mate with the interface adapter 501, and the mating design goal is to minimize discontinuities in the interface to avoid the formation of clots. The beak has a flange structure, which is located in the mid-region of the inlet connector 6251 and acts as a locking component that is received by the interface adapter 501.

[0088] During surgery, the closed end pouch design of the valveless blood pump 62 draws air into the pouch apex by buoyancy and collects air bubbles. See Figures 22 and 24. The proximal end casing 623 is fitted with or provided with an exhaust port 66, and a narrow passageway 661 is provided above the integral pouch pedicle septum 6301 between the proximal end stalk 630 and the blood pouch 629. In some embodiments, the passageway 661 extends along the centerline 62C. After matching the blood pump 62 to the target artery 60, the trapped air emerges under the pressure of arterial blood pressure and collects in the apex space of the blood pouch 629. A thin needle passes through the exhaust port 66, the passageway 661, the pouch pedicle septum 6301, and reaches the inside of the blood pouch 629 to expel the accumulated air. Because the entire capsule stalk 6301 below the exhaust port 66 is relatively rigid and not bent, the capsule 629 holding the perforation does not suffer further structural destruction, and structural destruction due to the propagation of cracks in the gaps of the perforation can be avoided when subjected to periodic pulse pressure or the expansion and contraction and folding of adjacent capsules.

[0089] As shown in Figures 23A and 25A, the pressure sensing mechanism 627 is embedded in the proximal end housing 623. Figure 23A shows a cross-sectional detail of the integrated proximal end housing 623, introducer 63, and drive catheter 67. Figure 25A shows the profile of the proximal end housing 623 that couples the introducer 63 extending from the dome of the proximal end housing 623 to communicate air and signals to the drive catheter 67.

[0090] As shown in FIG. 25A and FIG. 25B, the pressure sensing mechanism 627 includes a sensor 6271 hermetically housed in a metal can, and has a first space 6272 for fluid communication and a second space 6273 for housing a microelectromechanical system (MEMS) pressure sensor and associated electronic circuitry. A plurality of electrodes 6274 extend from the bottom of the second space 6273 and are connected to the wires 6702 of the carrier 67 (FIG. 26). The second space 6273 is closer to the driving catheter 67 than the first space 6272. The first space 6272 is open to communicate with the fluid of the sensing medium. A biocompatible fluid or jelly is used as the pressure transmission medium. A chamber or pressure sensing chamber 628 located in the proximal end housing 623 and adjacent to the first space 6272 is formed to confine a sensing fluid. The remote end of the pressure sensing chamber 628 is isolated from the blood cavity by a membrane sac 629. The pressure sensing chamber 628 has two side arms, a first arm 6281 for mounting the sensor 6271 and a second arm 6282 for filling and sealing the medium to be sensed. Thus, the blood pressure pulse can be transmitted through the transmembrane blood sac 629 and hydraulically communicated with the remote MEMS sensor 6271 located in the second space 6273.

[0091] One embodiment of the present invention innovates a pressure-based blood pump control method and sensor design. It employs a micro-MEMS pressure sensor whose electronics are packaged and embedded in the housing wall. In principle, due to its inherent microscale structure, the grains of the MEMS sensor are very durable. In practice, the durability of the sensor depends on the packaging design. This pressure-sensing mechanism 627 is non-blood contacting and isolated from the corrosive biochemistry associated with blood, providing the long-term signal collection and transmission required for long-term implantable assistive devices.

[0092] The carrier 67 functions as a transmitter for converting electrical signals and transmitting air pulse pressure between the blood pump 62 and the drive unit 98. A representative multi-layer carrier 67 of the present invention is shown in Figure 26. In this embodiment, the carrier 67 has an air lumen (or inner air tube) 6701, a plurality of electric wires 6702, an intermediate air tube 673, a coil 674 such as a metal coil, an outer layer tube 675, a tether 676, a silicone sheath 677, a rigid drive unit connector 678, and a protective hollow connector 679.

[0093] The central part of the carrier 67 houses an air lumen 6701 (or air passage, called inner tube) with a lumen diameter of 2-5 mm, which can choose between low power consumption and low operation convenience. The electric wire 6702 for signal transmission is embedded in the wall of the carrier 67. Other carrier variant designs can be adopted. In addition to the design of the multi-layer carrier 67 shown in FIG. 26, the carrier 67 may be multiple cavities, for example, as shown in FIG. 27, so that the electric wire 6702 can be embedded in several small tube chambers and pulse air can flow to the larger tube chamber 6701. One of the small lumens can be attached with a tether 676 to limit the elongation of the delivery 67 and protect the electric wire 6702 from damage by external pulling force.

[0094] The inner tube or air lumen 6701 is received by the air tube 673, with a reinforcement sandwiched between them. Between the inner tube 6701 and the air tube 673, a coil 674 (or a woven thread or net) can be reflowed) to reinforce the wall of the carrier material, making the carrier material 67 flexible but resistant to kinking. The outer layer tube 675 covers the inner and middle air lumen 6701 and the air tube 673, and a helically wound wire 6702 can be used as a protective cover. Note that in some embodiments, a non-expandable tether 676 can be provided between the outer tube 675 of the carrier material 67 and the silicone cover 677 to increase the tensile elasticity required during externalization of the carrier material 67. Clinically, the silica gel jacket 677 has been proven to be the least irritating to subcutaneous tissue and to have the lowest rate of transport infection.

[0095] In this embodiment, the air lumen 6701, metal coil 674, air tube 673, helical wire 6702, outer tube 675, tether 676, and silicone sheath 677 are packed in the body of carrier 67. The base end 671 of carrier 67 is inserted into a socket provided in drive 98. A rigid drive connector 678 of carrier 67 is adapted to be received in a socket in drive 98. The rigid drive connector 678 is mounted flush with a number of electrodes 6781 (e.g., four electrodes 6781 of FIG. 23) to which wires 6702 are soldered. A protective hollow connector 679 (see FIG. 23(b), FIG. 26) is positioned at the junction of the drive catheter 67 and the drive connector 678 to prevent the carrier 67 from kinking at the junction. The proximal end 671 of the carrier 67 includes the drive connector 678 and hollow connector 679 and is attached to allow easy exit from the skin without causing an unintended puncture injury.

[0096] As shown in Figures 22 and 23A, the connection between the carrier 67 and the blood pump 62 is achieved by an introduction member 63. Depending on the anatomy in which the blood pump 62 is implanted, the introduction member 63 can be located in the proximal housing 623 or in the distal housing 625. By integrating the introduction member 63 with the pump housing 62h, the overall external blood pump configuration can be changed to guide the transport member 67 in a specific direction, such as the externalization path of the transport member, post-operative skin care, equipment availability, etc.

[0097] As shown in Figs. 23A and 25A, the inlet 63 has a first part 631 which is an extension of the proximal housing 623, and the air chamber 6701, the tether 676 and the electric wire 6702 of the driving catheter 67 are connected to the first part 631 via the anchor adapter 672. The introduction member 63 further has a second part 632 which is linked to the first part 631 as a hollow connector of the carrier 67. The first part 631 is a position for connecting the electric wire, anchoring the tether, and bonding with the air chamber and sealing with the housing. The electric wire must not be exposed to the tissue at the implant site and must be protected from tension during the externalization process of the power transmission member. In addition, the connection between the air lumen 6701 and the blood pump 62 must be air-free and current-free. The above blood pump integration task is performed by the first part 631. The second portion 632 houses these interface components and acts as an external protector, shielding the interface from mechanical stress and environmental fluids and moisture.

[0098] 19 to 27 show a modular design of the first embodiment of the blood pump of the present invention. In this embodiment, the blood pump 62 includes an axisymmetric elliptical blood sac and stem assembly 650 (including a flexible membrane sac 629, a proximal stem 630 and a distal stem 640), a pump housing 62h having a proximal housing 623 and a distal housing 625, and a delivery member 67 connected to the blood pump 62, the delivery member 67 including an air lumen 6701 and an electric wire 6702 in its wall. An introduction member 63 is used to integrate the driving catheter 67 with the pump housing 62h and to realize electrical and pneumatic communication between the carrier 67 and the blood pump 62.

[0099] As shown in Figures 19 and 20, the design of the blood sac 629 and the stem 630, 640 connection has been disclosed in the previous section. The key to the design and manufacture is to maintain a precise axial symmetry in the part manufacture and the joining of the sac and stem assembly. The pressure sensitive mechanism 627 and the introduction member 63 are attached to the rigid part of the proximal housing 623. Figures 22, 23A and 23B show the design of the introduction member 63 in compaction. It can be seen that the compressed inlet 63 allows for a stronger and more fault tolerant wire and connection.

[0100] Figures 28A and 28B show some flow patterns associated with aortic balloon counterpulsation. During the late diastole and early systole of left ventricular bleeding, the blood pump draws aortic blood flow into the pump through pump filling (Figure 28A). The blood upstream and downstream around the connector becomes drawn into the blood pump with a sudden 90-degree flow. This causes flow separation and a low-velocity recirculation region T-201. Also, very high shear appears in the corner region of the T-joint. Meanwhile, during the diastole after the aortic valve closes, the blood stored in the pump is blown back into circulation, causing a shock flow on the opposite aortic wall (Figure 28B). This roll, impinging flow has a very high local pressure at the impinging point T-202, the so-called stagnation point, in which the flow velocity is practically zero and all the kinetic energy associated with the flow velocity is converted into potential energy, called the total pressure. Such high-pressure impinging flow may cause vascular maladaptation, such as smooth muscle cell proliferation and the resulting vascular wall stenosis, and the risk of aortic detachment due to persistent local hypertension. These non-physiological flow patterns and the induced high pressure, high shear, and low velocity recirculation phenomena are all ubiquitous near the T-tube. These turbulent, complex flow abnormalities are attenuated or diminished within a distance of 3-5 times the diameter of the implanted arterial lumen. The plug-in flow connector is designed with an insertion catheter length of 5-7 cm, covering most of the pump-induced non-physiological flow area. The aorta at the implant site is blocked by the inserted flow connector, so the native vessel wall is protected from the pathological stress conditions caused by the pump, and the artery at the implant site is protected from acute and long-term remodeling complications.

[0101] In anti-pulsatile support, the pump fills and ejects alternately in synchronization with the heart rate, resulting in a special T-joint flow as shown in Figures 28A and 28B. The aforementioned insertable aortic adapter 14 is further detailed in the perspective and cross-sectional schematic diagrams of Figures 29 and 30, respectively.

[0102] The aortic adapter 14 is mold injected and has an internal blood contact surface 141 that is ultra smooth, continuous, and free of parting lines. The aortic adapter 14 can be made of silicone or other polymeric elastomer materials. In some embodiments, the aortic adapter 14 is made of a polymeric elastomer that includes a silicone material, or the polymeric elastomer is mold injectable polyurethane. The aortic adapter 14 includes an aortic adapter catheter (or catheter insert) 142 for insertion into the aorta 95 (see FIG. 5 ) and a neck (or protuberance) 143 that connects to a blood pump. In this embodiment, the protuberant neck 143 includes a neck body 1431 and an extension 1432 on the neck body 1431, the extension 1432 protruding from the neck body 1431, and the maximum inner diameter of the extension 1432 is greater than the maximum inner diameter of the neck body 1431. When the convex neck portion 143 is connected to the blood pump 62, the extension portion 1432 is tightly attached to the inlet adapter 6251 of the blood pump 62, and the neck portion main body 1431 is surrounded by the coupler 25, integrally connecting the inlet adapter 6251 to the blood pump 62.

[0103] The aortic adapter 14 is thin-walled to maximize flow efficiency. To reinforce its thin-walled structure, a pair of nickel-titanium alloy metal stents (called truss rings) 144 are fitted over and surround both ends of the aortic adapter catheter 142 of the aortic adapter 14.

[0104] Figure 29 is a schematic diagram showing the fitting position of the nickel-titanium alloy metal stent 144. Also, the wall thickness of the aortic adaptor catheter 142 is gradually tapered toward both catheter ends 145. The gradually tapered wall thickness has a double effect. First, it maximally reduces the discontinuity of the graft 502 / subject connection, making the rate of interface clot formation much lower than the rate of thrombolysis provided by contact with the endothelium. Second, the compliance of the catheter becomes softer toward the catheter end 145, creating a compliance matching effect when connecting with the aortic lumen.

[0105] One of the complications that is troubling in the delivery of large stent-grafts 502 is the endoleak problem. Type I endoleak is an incomplete seal between the end of the implant and the implanted arterial endothelial lumen, resulting in a gap between the leading edge of the implant and the arterial lumen. The oozing blood is trapped in the gap and coagulates into a blood clot, and eventually into a fibrous pseudointima that grows uncontrolled over time. The pseudointima not only occludes the implanted artery, but also signals and stimulates the clotting mechanism, attracting platelet adhesion, which can lead to thrombotic failure. The solution to such endoleak problems is to tightly seal the aortic adaptor 14 against the lumen surface to which it is attached. The aortic adaptor 14 of the present disclosure proposes a compliant design concept that allows the semi-rigid catheter (terminal) end 145 to seamlessly attach to the arterial lumen when subjected to pulsatile pressure. As shown in Figure 30, the outer diameter 146 of the aortic adapter catheter 142 is slightly larger than the diameter of the inner lumen, such that the oversize ratio (defined as the ratio of catheter diameter to inner lumen diameter) is within the range of 3-10% under a given nominal blood pressure condition (e.g., 120 mmHg). The compliant catheter distal section 145 dynamically expands and contracts in response to pressure pulsations without creating a boundary gap when blood pressure fluctuates between systole and diastole, or under pulsatile pressure with counterpulsatile support.

[0106] Thin-walled elastomeric tubes are often flexible and compliant, but the bulk of the device is such that they are not strong enough to withstand the compressive forces applied, causing the wall of the inserted adapter to bend. Therefore, it is important to combine the nickel-titanium alloy metal stent 144 structure with an elastomeric substrate having a suitable hardness. As shown in FIG. 30, in this design, the nickel-titanium alloy metal stent 144 provides radial stiffness to support the aortic adapter 14 without bending, and there is a distance "x" between the outermost boundary 1441 of the metal stent 144 and the catheter end 145. In some embodiments, the aforementioned distance x needs to be evaluated and precisely defined. With the nickel-titanium alloy metal stent 144 as the support of an expandable frame, the gradually thinning catheter end 145 abuts the connected lumen wall, keeping it round without collapsing or wrinkling, and dynamically seals with the lumen. Furthermore, the aortic adaptor 14 can expand and contract in response to pressure pulsations, and the aortic adaptor 14 and the wall of the aorta 95 expand and contract together without causing bleeding complications, dynamically achieving a sealing effect that seals the catheter end 145.

[0107] FIG. 31 shows a representative embodiment of a nickel-titanium alloy stent 144, typically made of a laser-sculpted nickel-titanium alloy, which is further expanded by a series of expansion and heat treatments. FIG. 31 shows a flat development of the metal stent 144. (One row at a time) The metal stent has a multi-corrugated structure. The metal stent 144 is self-expandable, and can be folded or curled into small curls, placed in a pre-crushed roll, and self-released to return to its original shape after being placed in the required position.

[0108] A simple measure of catheter stiffness (the inverse of compliance) can be expressed as the so-called lateral stiffness (LS), and its measurement method is illustrated in FIG. 32. The lateral stiffness is defined as the applied force per unit length F divided by the corresponding radial deflection Y. For the current aortic adapter, a suitable lateral stiffness range is 0.01-0.05 Nt / mm2. The embedded nickel-titanium alloy metal stent 144 and the silicone resin or elastomer substrate contribute to the structural compliance of the coinjected aortic adapter 14. The structural compliance of the metal stent 144 and the structural compliance of the polymer elastomer of the aortic adapter 14 are approximately equal. It is preferable to have a uniformly distributed softness so that the tendency of layering between layers due to the expansion and contraction of the composite catheter wall is minimized, and the adapter 14 has a long life.

[0109] The aortic adapter 14 is arranged to be connected to a blood pump 62 to promote circulatory support. Here, a quick connector type coupler 25 is provided. As shown in FIG. 33, an exploded schematic view of each part of the coupler 25 in which the aortic adapter 14 and the blood pump 62 are integrated is shown. The coupler 25 includes a flange base 252, a pair of locking rings 253, and a hinge (or hinge assembly) 254 connecting the locking ring 253 and the flange base 252. A spring coil (or coil assembly) 255 is loaded into the hinge joint 256 to hold the locking ring 253 in an open position when the coupler 25 is unlocked (FIG. 34A). The locking mechanism relies on a leaf spring latch 257, which is made of a grooved spring piece and is fixed via a plate 2571 welded to one end of the locking ring 253. The flange base 252 has a substantially circular structure, and each locking ring 253 has a circular arc structure. The hinge joint 256 is located on a first side 252S1 of the flange base 252, and the leaf spring latch 257 is located on a second side 252S2 of the flange base 252 opposite the first side 252S1. The locking ring 253 is pivotally attached to the hinge joint 256 and is rotatable relative to the hinge joint 256 and the flange base 252. In some embodiments, the coupler 25 and the aortic adapter 14 are part of an aortic adapter assembly.

[0110] Fig. 34b shows a schematic diagram of coupler 25 in a locked state, with the slit of leaf spring latch 257 firmly engaged with beveled surface 258 to ensure a secure connection without risk of separation. As shown in Fig. 35, the integral connection between aortic adapter 14 and blood pump 62 is via the deformable adapter proximal end 147 (Fig. 30, i.e., the end of the neck) which acts as a "gasket" between rigid flange base 252 and rigid beak flange 81 (described below) of blood pump inlet adapter 6251, which are connected together.

[0111] Specifically, as shown in FIG. 34(b) and FIG. 35, the closed locking ring 253 can easily achieve quick-connect locking without worrying about accidental unlocking. The plate spring latch 257 is attached to the end of one of the locking rings 253. While the locking ring is locked, the plate spring latch 257 bends when it slides over the (convex) slope 258 of the opposite locking ring 253 during locking. When the plate spring latch 257 overcomes the top of the slope 258, it lowers to the bottom of the slope 258 by elastic restoring force, which acts as insurance against accidental unlatching and opening of the locking ring due to pump vibration or long-term rocking. In case of pump explant or replacement requiring module separation, the plate spring latch 257 is bent and lifted upward by the tool used, and an unlocking force is applied to rotate the locking ring 253 open, so that the blood pump 62 can be detached from the aortic adapter 14.

[0112] The design of a butt joint makes it impossible for a tube joint with two smooth surfaces to be connected in the bloodstream. In many clinical applications, the surface of the connected graft 502 is rough to promote endothelialization, whereby minute boundary discontinuities in the bloodstream are "smoothed out" by the ingrown cells and proteins. The current aortic adapter 14 avoids the occurrence of poor thrombosis by making the surface smooth, but the reason for this has already been explained. As shown in Figures 28A and 28B, the jetting and filling action of the blood flow in the aortic adapter in response to the counter-pulsating pump is bidirectional. This strong bidirectional flow and surface washing effect can easily remove any newly formed blood clots on the rough surface. Therefore, it is believed that a smooth surface design is more compatible with the present invention and is safer to use. The boundary of two connected smooth surfaces in the bloodstream requires careful mechanical and hemodynamic design to prevent in situ occurrence of thrombosis events. The principles and design methods related to the invention of such a new joint are disclosed below.

[0113] Figures 36A and 36B respectively show two fundamental boundary discontinuities that exist in a butt joint connection, such as a step 101, 102, or gap 103 between adapter AB1 (e.g., the adapter of blood pump 62) and adapter AB2 (e.g., the aortic adapter 14). Figures 36A and 36B are exaggerated illustrations; typically, in precision machining, such joint discontinuities are within 10-50 microns, which is large enough to cause clots and thrombus formation.

[0114] In reality, two separate objects need to be toleranced even if the machining of each object is exactly the same. Figure 36A depicts two misaligned fittings where everything about the part manufacturing is completed correctly except for the centerlines not being aligned. A step facing forward and a step facing backward 101, 102 are created, and stagnant flow in the step areas 101, 102 is the origin of clots or thromboemboli. As shown in Figure 36B, the non-parallel matching of the joints creates a boundary gap 103. The gap 103 attracts and collects blood cells, which further grow into a pseudointima. This intimal growth is often uncontrollable and can result in a thrombus bolus that is shed from the intimal surface as well as blocking the entire blood flow path. The incorrect boundary of the butt joint can be exacerbated if the connected objects are non-rigid. The aortic adapter 14 of the present disclosure is semi-rigid and can be forcefully press-fitted to connect to the fitting (e.g., inlet adapter) and has a deformed structure and enlarged boundary discontinuity. Therefore, in order to realize the connection between the current semi-rigid aortic adapter and the blood pump, it is necessary to invent a new connection means as follows.

[0115] 37 and 38. In some embodiments, the blood pump 62 has an inlet connector 80 that includes a beak flange 81, a beak 82, and a connector body 83 as an extension of the housing of the blood pump 62. The connector body 83 includes a number of holes 86 for connecting the inlet connector 80 to the blood pump 62.

[0116] The inner diameter 84 of the beak 82 is slightly larger than the inner diameter 148 of the convex neck portion 143 of the aortic adaptor 14 (see FIG. 30). The contact area between the beak 82 and the proximal (end) end 147 of the adaptor is an annular tapered surface (also called a shallow slope or bevel) 149 as shown in FIGS. 30 and 35, so that the beak 82 can be said to be a tapered beak. The shallow slope 149 is inclined with respect to the centerline of the catheter insertion section, and the taper angle of the shallow slope is in the range of 30-60 degrees measured from the rotation centerline of the inlet connector 80. In the initial locking engagement, the locking ring 253 with the internal groove 2531 facing inwardly is loosely hooked onto the flange of the flange base 252 and the flange of the beak flange 81. As the lock ring 253 is locked, the beak-shaped flange 81 (inlet connector 80) and flange base 252 (coupling 25) described above are housed in the internal groove 2531 of the lock ring 253 and pressed, compressing and clamping the middle silicone rubber end 147 (aortic adaptor 14), generating a clamping force that firmly connects the inlet connector 80 of the blood pump 62 to the aortic adaptor 14.

[0117] The above-described clamping force generating mechanism is shown in Fig. 35. The flange base 252 has two steps 2521 and 2522 for generating a clamping force. Before the locking ring 253 closes, the step 2521 should first be engaged with the locking groove 1433 (see Fig. 30) of the convex neck portion 143 of the aortic adapter 14. This engagement first bends and twists the convex neck portion 143, and then inserts the deformed convex neck portion 143 through the flange base 252. Due to the elastic restoring force of the aortic adapter 14, the bent convex neck portion 143 returns to its original circular (or shape), allowing the step 2521 to engage with the engaging groove 1433. The height Z of the internal groove 2531 of the locking ring 253 controls the pressing deformation of the adapter proximal end 147 of the convex neck portion 143. Refer to Fig. 35. In this locked configuration when the locking ring 253 closes and locks, the gap Z0 (i.e., the thickness Z0 of the pressed adapter proximal end 147) is smaller than the thickness Z3 of the end portion 147 of the aortic adapter 14 (see Fig. 30), that is, it can be seen that the thickness Z0 of the pressed adapter proximal end 147 is smaller than the thicker Z3 of the starting end portion 147 (Z0 < Z3). For the thickness Z0 of the pressed adapter proximal end 147, the following formula can be obtained from Fig. 35.

[0118] Z0 = Z - Z1 - Z2… Formula (1)

[0119] In Formula (1), Z1 and Z2 are the thicknesses for clamping the mating beak-shaped flange 81 and the step 2522 of the flange base 252, which are mating parts, respectively, as shown in Fig. 35. Usually, since the thickness Z3 is larger than the gap Z0, the distorted aortic adapter proximal end 147 generates the clamping force required to seal-connect the beak-shaped flange 81 and the annular flange base 252. The distortion of the adapter proximal end 147 is defined as [Z3 - Z0] / Z3 and is within the range of 10 - 30%, which is sufficient to ensure a reliable sealed connection.

[0120] FIG. 39 shows the interface characteristics of the current connection between the beak 82 and the tapered surface 149 of the adapter. When connected, the beak 82 and its beak leading edge 85 sink into the semi-rigid tapered surface 149, and the aortic adapter 14 has a depth equivalent to the leading edge radius of the beak leading edge 85, typically 30-50 microns. In FIG. 39, the dotted line and bracketed numbers indicate the initial contact between the beak 82 and the beak leading edge 85, while the solid line and open bracketed numbers indicate the locked position. Note that the interface discontinuity is reduced by the recession of the tapered surfaces 149, 82 from their original shape (dashed lines). The thickness of the internal groove 2531 controls the tight fit of the connection. As previously mentioned, the elastic aortic adapter proximal end 147 is compressed at a strain of approximately 10-30% to provide the necessary connection strength to counter pulsatile pumping.

[0121] The current design of the interface connection between the blood pump 62 and the aortic adapter 14 has two hemodynamic advantages that reduce insitu thrombus formation. First, it has been observed that the conventional docking connection does not actually result in a step or gap type joint discontinuity. Second, the stagnation flow at the boundary of the beak leading edge 85 is minimized. This allows for faster blood flow through the connection interface and significantly improves the docking connection defects, i.e., the forward or backward steps 101, 102 or gaps 103 that previously occurred at the interface.

[0122] The tapered shallow bevel 149 in this embodiment is inclined at an inclination angle relative to the flow direction. Such a slope interface design avoids the occurrence of steps or gaps in the joint due to limited manufacturing precision or matching eccentricity associated with conventional docking connections. However, this tapered shallow bevel 149 has an inherent deficiency in achieving concentric centerline alignment of the mating counterparts. The connection between the aortic adapter 14 and the beak 82 does not have a strict lateral constraint to ensure the mating alignment. In order to concentrically connect the rigid beak 82 and the semi-rigid shallow bevel 149, it is important to simultaneously hook the locking ring around the entire periphery of the flange base 252. If the simultaneous locking / locking engagement is not completed, the first locked shallow bevel 149 will tend to distort and tilt or position the remaining contact surface more than the other free parts, resulting in an eccentric connection to the pump. Such an eccentric joint is usually the cause of steps and gaps in the interface, which leads to thrombus formation. This deficiency is compensated for by arranging the distal (lower) locking ring contour 259 (FIG. 34A) of the locking ring 253 to include all circumferential contact areas simultaneously with locking engagement. Upon locking, the contact edge of the metal (in some embodiments) beak 82 sinks slightly into the shallow bevel 149 of the controlled depth compressed silicone material (in some embodiments), further reducing boundary discontinuity upon exposure to blood flow. Moderate administration of anticoagulant can significantly reduce or eliminate normal boundary thrombosis.

[0123] The deformability of the structure and the delivery method for the aortic adapter 14 provide the special design features of the present invention. Indeed, the consideration of the elasticity of the material should be carefully incorporated into the present design. In terms of intraoperative safety and long-term reliability, it is difficult to deliver the insertable graft 502 into the aorta through open aortic wall surgery. Therefore, in some embodiments, the material selected for the aortic adapter 14 should have a predetermined memory shape. During device installation, the adapter 14 is first crimped into a small retention form (crimped adapter 14 as shown in FIG. 40), which ensures fast and safe device implantation. After the curled aortic adapter 14 is placed at the desired implant site, the retention form aortic adapter 14 should be released and self-expand to its original memory shape.

[0124] Prior to inserting the aortic adaptor 14, a hole 12-14 mm in diameter should be formed in the aortic wall. Care should be taken when creating such an access hole to avoid creating edges that may serve as the initiation point for cracks, as the wall must be expanded as the device is inserted. A side-biting aortic perforator, such as that disclosed in U.S. Patent Application No. 17 / 034036, is an ideal tool for creating a large hole in the aorta. Only a light tap is needed to create an unbroken hole.

[0125] The aortic adaptor 14 is morphologically comprised of two connected circular tubes, forming a t-shaped flow connector for performing para-aortic circulation support. The thickness of the catheter wall is usually 1-2 mm, and the material used is a polymer with suitable hardness, such as silicone resin or urethane, with a hardness of Shore A 80-90. The curl-in structure is significantly different from the large stent graft 502 covered with commercial duck nylon or PTFE (polytetrafluoroethylene) fabric. Figure 40 shows the curl / embed configuration of the aortic adaptor 14. (A metal stent 144 made of nickel-titanium alloy is inserted and deformed together with the aortic adaptor 14 with the polymer matrix). The aortic adaptor 14 is folded by inserting a collapsed catheter into a part of the aortic adaptor catheter 142, and the t-shaped convex neck portion 143 is accordingly crushed and flattened, and sinks into the folded adaptor 14 body, as shown in Figure 40. Of these, the diameter of the bent aortic adaptor 14 is approximately half the diameter of the original deployed circle.

[0126] The adapter 14 folded in this way can be held fixed by tensioning a rope, as shown in FIG. 40. Three fixing strings can be installed at both edges and at the center of the catheter, but other fixing methods are also possible. FIGS. 41A, 41B, 41C, and 41D show four representative stages of the aortic adapter 14 in the indwelling form. The first stage (see FIG. 41A) shows an initial transmission image of the pre-roll sac (of the aortic adapter 14) passing through the access hole in the form of a curled pre-roll sac when the pre-roll sac (of the aortic adapter 14) is inclined at a certain angle with respect to the axis of the aorta 95. The second stage (FIG. 41B) shows the aortic adapter 14 in the fully inserted form entering the aorta, with the pre-roll sac passing through the access hole and one end of it rotating and dropping into the access hole. After that, the fully inserted pre-roll sac is returned to its original position, and the curled neck portion 143 is aligned with the access hole (FIG. 41C). The restrained ties are released to allow the curled compressed aortic adapter 14 to return to its original shape by elastically self-expanding (FIG. 41D). The released aortic adapter 14 is tightly surrounded by the aortic lumen, which is guaranteed by the appropriate oversize ratio selected before placement. The T-shaped convex neck portion 143 can be slightly deformed and the flange base 252 (FIGS. 33-34B) of the coupler 25 can be attached to the T-shaped convex neck portion 143 in preparation for connecting the blood pump 62. To this end, the blood pump connection can be easily achieved by setting the inlet beak 82 on the tapered shallow slope 149, and then closing the two locking rings 253 of the coupler 25 to achieve a firm device connection.

[0127] Additional safety measures can be applied to enhance hemostasis and stability of the implanted para-aortic blood pump system. Due to the weight of the blood pump 62 and the pumping force from the counter-pulse support, the placement of the blood pump near the aorta necessarily involves lateral forces (perpendicular to the longitudinal direction of the aorta) and torque on the aortic adaptor 14. The external forces associated with this device may affect the long-term reconstruction of the vasculature at the implant site. A purse-string suture can be placed in the adventitial layer around the hole. The band suture can provide extra tightening of the aortic wall around the inserted adaptor 14 and is used as a protective measure to prevent the enlargement of the access hole. Additionally, surgical tape can be wrapped and tensioned around both ends of the aortic adaptor catheter 142 to strengthen the integral bond between the inserted aortic adaptor 14 and the aorta. Proper design and tightening of the annular tape can provide a double protection against endoleak. In some cases, blood pressure may exceed the upper limit for compliance matching without endoleak. In these extreme circumstances, the surgical tape comes into play and acts as a hard limiter, sealing the ends of the adapters attempting to separate and ensuring hemostasis.

[0128] As shown in FIG. 42, in some embodiments, the stepwise setup for implanting the aortic adaptor 14 is detailed herein. Before starting the implantation, the aortic adaptor 14 is prepared in a curled pre-rolled pouch / compressed placement format. After exposing the target thoracic artery through a left thoracotomy, a cross clamp distance of approximately 10 cm spanning the implant site is determined. The access hole to be drilled in the aorta is first marked with a peri-hole marker. Then, the sutures of the band are sutured outside the periphery of the hole in the adventitial layer. The aorta can be partially separated from the surrounding connective tissue, and a pair of surgical tapes can be wrapped around the aorta. After the above preparations are completed, the cross clamp and insertion of the aortic adaptor are performed. These insertion steps are described in the steps shown in FIG. 17. First, the aorta is cross-clamped to provide an isolated segment without bleeding issues. Then, a customized aortic perforator is used to create a large access hole for the insertion of the aortic adaptor 14. Next, the folded adapter pre-roll sac is inserted and placed on the cross-clamped aortic segment, as shown in Figures 41A, 41B, and 41C. The folded adapter 14 is then released and returned to its original unfolded configuration, as shown in Figure 41D. It is then tightened with a ties and tape as an additional protection against hypertensive endoleakage. The coupler 25 is then attached and its step 2521 engages with the locking groove 1433 of the convex neck portion 143 of the aortic adapter 14 in preparation for receiving the blood pump 62 to be connected. The self-alignment ability of the coupler 25 as described above allows the inlet connector 80 of the blood pump 62 to be accurately positioned and locked to the aortic adapter 14. The remaining implantation procedure is normal, including releasing the cross clip, evacuating the blood pump, and assisting in starting the pump. Generally, for a skilled surgeon, the cross-clamp time required to insert the aortic adapter is about 10 minutes. During this cross-clamp period, the abdominal organs are deprived of blood perfusion, which may cause ischemic damage. To reduce potential surgical damage to these organs, femoral-femoral extracorporeal membrane oxygenation (ECMO) support can be used to perfuse the abdominal organs and lower extremities.However, the surgeon decides whether to use ECMO support or not. Usually, a normal patient can tolerate 20 minutes of ischemic time.

[0129] As described above, according to an embodiment of the present invention, a ventricular assist device is provided, comprising a blood pump, a transfer member and an introduction member. The blood pump includes an axisymmetric elliptical blood sac and stalk assembly, the system including a flexible blood sac, a proximal stalk and a distal stalk, in which the flexible blood sac is connected to the proximal stalk and the distal stalk, providing a stress relief suspension mechanism. The blood pump further includes a pump housing including a proximal housing and a distal housing, the stress relief suspension mechanism being connected to the pump housing. The blood pump further includes a built-in pressure sensing system in the proximal housing, the pressure sensing system including a blood pump pressure sensor and a pressure sensing chamber filled with an incompressible fluid for pressure transmission. The carrier includes an air chamber and at least one wire and tether included in the wall of the carrier, the wire and tether being provided in the wall of the carrier. The inlet connects the delivery to the pump housing.

[0130] An embodiment of the present invention discloses a pulsating blood pump design that combines the concept of a non-stationary fold line with the structure of a long-term blood sac, which can substantially extend the durability of a displacement blood pump. Also provided is a micro pressure-sensing system that can be used as a reference waveform for real-time pump control and long-term trend analysis based on real-time big data, and disease monitoring and diagnosis based on real-time big data. In addition, the implantable pressure-sensing system does not contact blood, so the reliability requirements for building an implantable sensor system are greatly increased.

[0131] Embodiments of the present invention have at least any of the following advantages or effects: The inlet of the delivery and pump housing is connected to provide a compact inlet design for more robust and fault-tolerant cord and signal transmission; and the post-pressure introduction design integrates the induction wire, air tube, and blood pump. This compactness attribute is particularly important for implantable devices; it not only simplifies the surgical procedure and reduces the risk of perioperative implantation, but also helps reduce postoperative morbidity associated with delivery infection.

[0132] In some embodiments, the introduction member is integrated into the remote housing of the pump housing, and the introduction member has a first portion that is an extension of the remote housing, to which the air chamber, tether, and wires of the power transmission member are connected, and a second portion is used in conjunction with the first portion as a hollow connector for the carrier to achieve the advantages of anatomical adaptability and adaptability to the various shapes of the implant site.

[0133] It is therefore an object of the present invention to provide an aortic adaptor assembly capable of implanting a ventricular assist device, the aortic adaptor assembly including a T-shaped flow connector including a catheter insert and a convex neck portion, the catheter insert and the convex neck portion being connected to each other, both of which have a smooth surface in contact with blood, and a metal stent disposed in the catheter insert, the T-shaped flow connector including a polymeric elastomer reinforced by a metal stent having a nickel-titanium alloy material, the catheter insert having a gradually thinning wall at both ends of the catheter end, the distal end of the catheter end being a suitable distance to the outermost boundary of the metal stent, the catheter end being compliantly matched to the artery at the implant site, and the proximal end of the convex neck portion being arranged to be connected to an inlet adaptor of a blood pump.

[0134] The embodiments of the present invention have at least one of the following advantages or effects. The present invention discloses a flow connector assembly that can allow blood flow into and out of a para-aortic ventricular assist device, especially a counterpulsatile blood pump. Unlike conventional flow connectors that adopt many existing surface roughening methods to promote endothelialization and avoid the occurrence of thrombosis maladaptation events, the aortic adapter of the present disclosure adopts the concept of a smooth surface, an insertable pseudograft 502 to construct the flow connector. In addition, a flexible matching design is applied around the end of the inserted catheter, combining the gradually thinning wall characteristics with a thin-walled polymer supported by a superelastic nickel-titanium alloy frame to achieve the requirement of no endoleakage. The abnormal high pressure, high shear and low recirculation flow phenomena associated with para-aortic counterpulsatile pumping are included in the artificial surface to insert the catheter. Therefore, the hemodynamic effects and risk factors of pathological devices are almost eliminated, and the long-term vascular maladaptation events such as endothelial cell erosion, lipid infiltration, smooth muscle cell proliferation, vascular stenosis, and arterial wall peeling are obviously reduced. In order to achieve a good connection between the semi-rigid flow adapter and the blood pump, the present disclosure provides a quick-fitting coupling. The coupler has a self-aligning interface design, minimizing step and gap discontinuities and reducing the possibility of thrombotic failure at the interface junction. In cooperation with the invention of the aortic adapter, a specially designed deployment method can be provided to ensure a fast and safe deployment process. The curled aortic adapter is pre-wrapped / deployed, and the overall size is reduced to half of the initial size. The pre-rolled sac adapter can be easily inserted into the aorta at the implant site and expand to the initial position by itself, forming an affixed flow connector without the worry of endoleakage. It not only reduces the risk of implantation during surgery, but also helps to reduce postoperative morbidity associated with device-induced flow and poor vascular adaptation at the implant site.

[0135] Ordinal numbers, e.g., "first", "second", etc., in this specification and in the patent application have no sequential relationship to one another and are used only to indicate a distinction between two different components that have the same name.

[0136] The embodiments described herein are intended to provide a method and apparatus for the preparation of a method for producing a semiconductor device, the method comprising the steps of: (a) providing a method for producing a semiconductor device comprising the steps of: (a) providing a method for producing a semiconductor device; [Explanation of symbols]

[0137] 10, 20, 30, 40, 90 Paraaortic Blood Pump Device 11, 21, 31, 41 Battery supply system 12, 22, 32, 42, 52, 62, 92 Blood pump 14, 24, 34, 44, 54, 64, 94 Aortic Adapter 16, 26, 36, 46 Drive Catheter 18, 28, 38, 48, 78, 98 Drive unit 25, 45, 65 Coupler (Coupling Adapter) 33, 43, 93 Drive Catheter Interconnector 37, 47, 57, 67, 97 Distal drive catheter 39, 49, 99 Proximal drive catheter 52h, 62h Rigid housing 523, 623 Proximal End Housing 525, 625 Remote Housing 526 Capsular membrane 529 Blood Sac B blood chamber A Air chamber 527 Pressure-sensitive mechanism 528 Pressure Sensing Chamber 530 Proximal Port 540 Remote Port 545, 645 Catheter end 101 stairs 102 stairs 103 Gap 141 Blood contact surfaces 142 Aortic Adapter Catheter 143 Convex neck 1431 Neck body 1432 Extension 1433 Card Slot 144 Metal Stents 1441 Outermost Boundary 145 Catheter End 146 Outer diameter 147 Adapter proximal end 148 Inner diameter 149 Shallow Slope 252 flange base 221 Stairs 222 Stairs 252S1 1st side 252S2 2nd side 253 Lock Ring 231 Internal groove 254 Hinge 255 Spring coil 256 Hinge Joint 257 Leaf Spring Latch 571 Plate 258 Slope 259 Lock Ring Contour 50 Connectors 501 Adapter 502 Transplant 503 Connector 504 Remote 63 Introduction materials 62A Inverted membrane 621 Groove 623 Proximal end housing 625 Remote Housing 6251 Inlet Connector 6252 1st end 6253 2nd end (23A)6254 627 Pressure-sensitive mechanism 6271 Sensor 6272) 1st space 6273 2nd space 6274 Electrode 628 Pressure Sensing Room 6281 First Arm 6282 Second Arm 629 Blood Sac 630 Proximal end pedicle 6301 Cystic septum 631 Part 1 632 Part 2 640 Remote Stem 643 Neck 650 Stem Assembly 66 Exhaust port 661 Aisle 67 Transport materials 6701 Air Lumen 6702 Electric wire 61) Proximal end 672 Anchor Adapter 673 Air Tube 674 Coil 675 Outer tube 676 Tether 677 Silicone Sheath 678 Rigid Drive Connector 6781 Electrode 679 Hollow Connector 60 arteries 6291 Proximal end 6292 Remote 6293 Three-petal type 6294 crease 62C center line 71 Battery hatch 73 User Interface Panel 75 Drive Catheter Socket 77 External power socket 79 Vent 80 Inlet Connector 81 Beak-shaped flange 82 Beak 83 Connector body 84 Inner diameter 85 Beak front edge 86 holes 971, 991 Drive catheter internal body segment 973, 993 Drive catheter extracorporeal segment 95 Aorta 96 Drive Catheter EX exit part OP Opening 110 Electromechanical actuator 120 Motor Controller Unit 130 Microcontroller Unit 140 Power Management Unit 150 Battery Module 170 User Interface Module 190 Clinical Monitor T-201 Slow recirculation area T-202 Impact Point AB1 Adapter AB2 Adapter

Claims

1. 1. A para-aortic blood pump device comprising: a blood pump including a pump housing, a blood sac, and a pressure sensor, the blood sac being disposed within the pump housing, the pressure sensor being mounted within the pump housing, the blood pump configured to monitor blood pressure within the blood pump and generate an electronic blood pressure signal; an aortic adapter, which is a T-catheter connected to the blood pump for connecting the blood pump to the human aorta; a drive catheter coupled to a housing of the blood pump for transmitting the electronic blood pressure signal received from the pressure sensor; a drive section connected to the drive catheter to receive the electronic blood pressure signal, the drive section including an electromechanical actuator for generating air pressure pulses based on the electronic blood pressure signal and for providing the air pressure pulses to the blood pump via the drive catheter; The blood sac is contained within the housing of the blood pump, the blood sac is an egg-shaped membrane body with a center line of the blood pump as a center of rotation, and two polymer ports are connected to the blood pump at both ends. When the membrane body is attached to the housing of the blood pump, the polymer ports function as a bending and stretching release mechanism and can reduce stress concentration. Para-aortic blood pump device.

2. 2. The para-aortic blood pump device of claim 1, wherein the drive section further includes a drive catheter controller for processing the electronic blood pressure signal and a vibrator for providing an audio alarm or tactile feedback.

3. 2. The para-aortic blood pump apparatus of claim 1, A para-aortic blood pump device in which the drive catheter and part of the drive unit are replaced with a distal drive catheter, a drive catheter interconnector, and a proximal drive catheter, and the distal drive catheter is for transmitting the electronic blood pressure signal and the air pressure pulses to the blood pump, and the drive catheter interconnector includes a drive catheter controller for processing the electronic blood pressure signal and a vibrator for providing an audio alarm or tactile feedback.

4. 2. The para-aortic blood pump apparatus of claim 1, A para-aortic blood pump system, wherein the blood pump is integral with the aortic adapter.

5. 2. The para-aortic blood pump apparatus of claim 1, The para-aortic blood pump system further comprising a coupler, the coupler including a coupling adapter attached to a neck of an aortic adapter to couple the blood pump to the aortic adapter.

6. 2. The para-aortic blood pump device of claim 1, wherein the gradually expanding ends of the aortic adapter form a smooth transition in elastic properties, and the aortic adapter gradually softens as the wall thickness of the catheter into which it is implanted within the aorta decreases.

7. 2. The para-aortic blood pump apparatus of claim 1, A para-aortic blood pump system, wherein the pump housing of the blood pump has an opening which is integrated with the aortic adapter and forms a seamless smooth boundary where it joins with the neck of the aortic adapter.

8. 2. The para-aortic blood pump device of claim 1, wherein the electromechanical actuator includes a pressure balance valve connected to a cylinder of the electromechanical actuator, the pressure balance valve periodically opening to balance the air pressure in the cylinder with atmospheric pressure.

9. 2. The para-aortic blood pump apparatus of claim 1, A para-aortic blood pump device provides a pulsatile boost of systemic blood flow during diastole (heart diastole) to improve perfusion of the myocardium and organs, and reduces the working load of the left ventricle during systole (heart contraction).

10. 2. The para-aortic blood pump device of claim 1, wherein the driving section includes a trigger detection microcontroller unit that provides a blood pressure waveform detected in the blood pump, and the trigger detection microcontroller unit calculates and determines an injection fill time of the electromechanical actuator.

11. 2. The para-aortic blood pump apparatus of claim 1, The electromechanical actuator includes a motor and a ball screw unit that reciprocates a piston in a cylinder that drives the electromechanical actuator to inject and inject air, and the movement of the piston is transmitted through the drive catheter connected to the blood pump to drive the blood pump.

12. 2. The para-aortic blood pump apparatus of claim 1, the electromechanical actuator being an air actuator; A piston-cylinder assembly that uses a brushless servo motor, a ball screw unit, and air as a driving medium to reciprocate and charge the blood pump; and a pressure balance valve attached to the air actuator to solve the problems of gas leakage from the anti-leak ring of the piston-cylinder assembly and condensation of water vapor exuded from the blood sac.

13. 11. The para-aortic blood pump system of claim 10, The drive unit receives the electronic blood pressure signal and processes the electronic blood pressure signal using a trigger detection algorithm to generate a trigger signal, the trigger signal in cooperation with the heart rate instructing the drive unit to operate.

14. 14. The para-aortic blood pump system of claim 13, After receiving a predetermined trigger time, the trigger detection microcontroller unit sends an instruction to the motor controller to drive the piston movement of the electromechanical actuator from ejection to filling or from filling to ejection position, respectively, to provide counter-pulsatile circulatory support including contraction withdrawal during systole and perfusion augmentation during diastole in a para-aortic blood pump device.

15. 2. The para-aortic blood pump apparatus of claim 1, The para-aortic blood pump apparatus, wherein the drive section further includes a user interface module including an indicator, an audio alarm, buttons, and a liquid crystal display.

16. 11. The para-aortic blood pump system of claim 10, When the trigger detection microcontroller unit loses the electronic blood pressure signal from the blood pump, the trigger detection microcontroller unit automatically activates a flushing mode and drives the electromechanical actuator to operate at a predetermined drive frequency and drive stroke amount.

17. 17. The para-aortic blood pump system of claim 16, A para-aortic blood pump system, wherein the flushing mode is a system protection mode for preventing clot formation in the blood pump without providing circulatory support.

18. 2. The para-aortic blood pump apparatus of claim 1, The para-aortic blood pump device, wherein the blood sac is secured to a proximal end of the pump housing via a proximal port and secured to a distal end of the pump housing via a remote port.

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