Endo-leak-free aortic adapter assembly and device delivery method.

Description

1 / 62 Endo-leak-free aortic adapter assembly and device delivery method. FIELD OF THE INVENTION

[001] The application refers, in general, to an inlet / outlet cannula associated with the connection of a blood pump to large arteries and, more specifically, to para-aortic counterpulsatile circulatory support devices for heart failure and the associated less invasive method of cannula delivery. DESCRIPTION OF THE RELATED TECHNIQUE

[002] Mechanical circulatory support systems, particularly left ventricular assist devices (LVADs), are continuously evolving into a standard of care for the recovery of advanced heart failure. LVAD systems can generally be classified into continuous-flow and pulsatile-flow pumps, depending on the mechanical design of the blood pumps. Continuous-flow devices are built on rotating machines driven by axial or centrifugal flow impellers. Pulsatile-flow devices, on the other hand, are designed using a displacement-type blood pump, and often a diaphragm blood bag is employed to receive and eject blood into and / or out of the pump.

[003] Inlet / outlet cannulas are artificial flow conduits for connecting LVAD systems, in series or in parallel, to the human circulatory system. Historically, flow cannula design has received less attention compared to blood pump actuators. Unsurprisingly, a significant number of postoperative complications have arisen related to inlet / outlet cannula malfunction. Adverse events such as cannula malpositioning, obstruction, thrombus formation, and the resulting distorted flow, leading to pump thrombosis and thromboembolism. For rotary pump implantation, establishing the flow passage is primarily achieved by connecting the cannula to Petition 870260041021, dated 04 / 05 / 2026, page 16 / 142 2 / 62 The inlet leads to the heart chamber, and the outlet cannula leads to the ascending or descending aorta. To date, almost all rotary pump outlet cannulas have adopted Dacron or similar grafts, made of flexible tissue materials, and the connection to the artery is made through the end-to-side anastomotic suture method. This end-to-side anastomosis depends on skill, and complications caused by unskilled suturing or incorrect direction of flow to the aorta can lead to clot formation, stroke or thromboembolism, and infarction in downstream organs.

[004] Rotary pumps offer full cardiac output support (4-10 l / min) and are currently indicated for end-stage heart failure. For less severely ill patients, a less invasive implantable LVAD with partial support (2-3 l / min) is considered more appropriate. Partial support LVADs are intended to intervene early in heart failure to improve treatment outcome. In this new trend of implanting less invasive, partial support LVADs, the counterpulsatile blood pump has been the main focus due to its proven effectiveness in systolic discharge to the heart and diastolic increase in blood perfusion to the myocardium and major organs. Counterpulsatile pumping must follow strict timing criteria in relation to the heart rhythm.Typically, the discharge of ventricular contraction is initiated near the end-diastolic point, while the increase in organ perfusion occurs at the moment of aortic valve closure (dicrotic notch in the aortic pressure waveform). The therapeutic effects provided, in fact, reside in two aspects, including, first, the discharge of ventricular contraction that leads to a reduction in myocardial oxygen consumption and, second, the elevation of diastolic blood pressure to help increase perfusion in the myocardium, brain, and major organs.

[005] The effectiveness of counterpulsatile support is clinically demonstrated by the intra-aortic balloon pump via peripheral subcutaneous administration of the balloon pump. However, peripheral supply to the descending aorta is frequently affected by vascular complications at the site of Petition 870260041021, dated 04 / 05 / 2026, page 17 / 142 3 / 62 insertion and encounters difficulty in long-term use. In the treatment of heart failure, it is of great interest to extend counterpulsatile support from acute support (less than one week) to long-term support (months to years). To meet this requirement, innovative surgical methods and device innovation are needed to achieve this goal of long-term counterpulsatile support.

[006] The present counterpulsatile support is performed via left thoracotomy with a device connected to the thoracic artery. This counterpulsatile invention, termed a para-aortic blood pump, is implanted via a lateral connection of the pump through an access orifice made in the descending wall of the aorta. In stark contrast to the intra-aortic balloon pump, the para-aortic blood pump does not obstruct blood flow and is therefore more flexible in controlling counterpulsatile timing. Animal studies have demonstrated that the effectiveness of hemodynamic support from para-aortic counterpulsation is better than that of the intra-aortic balloon pump. However, it is unknown whether para-aortic pump support can induce long-term complications. Indeed, the challenge lies in constructing a less invasively implanted flow cannula that can safely allow long-term fluid communication between the pump and the connected artery.

[007] Implantation of the para-aortic blood pump requires the creation of a prosthetic conduit to allow blood flow to enter and be ejected from the blood pump. Rapid pump loading is generally necessary for effective reduction of left ventricular afterload as well as to create strong vortex washout to prevent pump thrombosis. This rapid pump loading often suffers from transient low pressure leading to collapse of the flow conduit. The use of conventional Dacron graft-type cannulas is therefore not feasible as the tissue conduit cannot withstand the compression force, and the collapsed graft may obstruct inflow during the pump loading phase. Furthermore Petition 870260041021, dated 04 / 05 / 2026, page 18 / 142 4 / 62 of this, the high and low pressure pulse induced by the rapid ejection and loading of the pump will present a bleeding problem at the suture site, especially in the acute period when the surgical anastomosis has not yet healed. It is of utmost importance that a flow cannula be designed to overcome all these specific flow characteristics associated with para-aortic counterpulsation.

[008] The hemodynamic characteristics of para-aortic blood pump flow are not physiological. The blood flow drawn in or ejected from the connected blood pump is not laminar in the arterial direction, as is generally seen in the natural aorta. This artificially generated, side-discharge pump flow is highly turbulent and complex. During the pump loading phase, the flow makes a sharp inward curve into the blood pump, with flow separation and a recirculation zone generated at the corner of the flow curve. In the pump ejection phase, as the flow is accelerated into the descending aorta, the flow is distinguished by an impact flow with ultra-high pressure and shear stresses transmitted to the opposite region of the aortic wall.The characteristics of this device-induced flow include a low-velocity recirculation zone and a high-pressure, high-shear jet flow, which could potentially cause endothelial cell erosion, lipid infiltration, smooth muscle cell proliferation, chronically resulting in aortic wall stenosis or thrombus formation or aortic dissection due to hypertension. Therefore, a long-term implantable counterpulsatile device design must innovate a prosthetic flow cannula that can prevent or mitigate the aforementioned device-induced pathophysiological flow phenomena and the resulting vascular maladaptation, as well as adverse events of thrombotic or aortic dissection.

[009] Safety in surgical anastomosis is another requirement for a para-aortic counterpulsatile pump flow cannula design. Conventional graft suturing can encounter challenging hemorrhagic complications when subjected to excessive high-pressure fluctuations associated with flow. Petition 870260041021, dated 04 / 05 / 2026, page 19 / 142 5 / 62 counterpulsatile. The high- and low-pressure cycle is the main driving force for material fatigue failure, particularly when the implanted aorta is diseased (atherosclerosis or calcification), degenerated (decreased wall thickness), or aged (hardened wall). Note that the aortic wall structure is adaptive in response to the imposed stress condition. The cells and tissues around the implant site would be remodeled along with the surgical wound healing process and would develop according to the non-physiological mechanistic environment induced by the device. Even if short-term implantation success is achieved, this does not guarantee that long-term graft failure will not occur in the postoperative course due to gradual cellular and morphological maladaptation in the vascular wall.

[010] To date, all viable solutions for end-to-side connection of artificial grafts to arteries rely on flexible tissue tubing via suture methods. There are no long-term cannula solutions in the device industry that can solve the problems related to the level of fluctuation in flow and pressure produced by a counterpulsatile para-aortic blood pump. The effectiveness of short- to medium-term counterpulsation (days to a month or more) has been clinically achieved through intra-aortic balloon pump applications for over fifty years. This classic means of pneumatic energy transfer to drive balloon inflation / deflation was achieved using a thin catheter administered percutaneously from remote peripheral arteries with a lumen diameter in the range of 6-10 mm.These arteries at the delivery site are largely blocked, which often causes severe hemorrhagic complications and downstream ischemia in limbs or arms, preventing percutaneous balloon counterpulsation due to long-term use. Para-aortic placement is a newly devised approach, aiming to extend counterpulsatile therapy for a longer period of time. However, long-term para-aortic counterpulsation requires the construction of a flow communicator to address the characteristic implantation problems mentioned above. This flow cannula should be no. Petition 870260041021, dated 04 / 05 / 2026, page 20 / 142 6 / 62 collapsible, easily implantable, bleeding-free and biocompatible, without the concern of inducing pathological vascular maladaptation. The present invention aims to satisfy all collective requirements, proposing an insertion-type aortic adapter, which will be disclosed below. BRIEF SUMMARY OF THE INVENTION

[011] To address the shortcomings of conventional products, one embodiment of the invention provides an aortic adapter assembly for an implantable ventricular assist device, which includes: a T-shaped flow connector, which includes: an inserted conduit portion, an extruded neck portion, both of which have a smooth blood contact surface, wherein the inserted conduit portion is joined to the extruded neck portion; and a truss, disposed on the inserted conduit portion; wherein the T-shaped flow connector has a polymer elastomer reinforced by the truss which has a Nitinol material; wherein the inserted conduit portion has a wall that gradually tapers at two conduit ends of the inserted conduit portion, with an appropriate distance from one end of the conduit end to the outer limit of the truss, and the conduit end has a matching effect with an artery at the implant site;wherein a proximal end of the extruded neck portion is configured to be attached to an inlet adapter of a blood pump.

[012] In some embodiments, the truss is co-injected with a polymeric substrate of the connector and embedded in the wall of the inserted conduit portion.

[013] In some embodiments, the polymeric substrate is manufactured from a silicone material.

[014] In some embodiments, the polymeric substrate is a mold-injectable polyurethane.

[015] In some embodiments, the structural conformity of the embedded truss and the structural conformity of the polymeric substrate are substantially the same as each other. Petition 870260041021, dated 04 / 05 / 2026, p. 21 / 142 7 / 62

[016] In some forms, the ends of the gradually thinner conduit have sharp edges.

[017] In some embodiments, the extruded neck portion has a shallow sloped surface to match a blood pump inlet adapter, and an inner diameter of the extruded neck portion is slightly smaller than an inner diameter of the blood pump inlet adapter.

[018] In some embodiments, the shallow inclined surface is inclined in relation to a direction of extension of the inserted portion of the conduit.

[019] In some forms, the truss has a plurality of wavy structures.

[020] In some embodiments, the extruded neck portion includes: a neck body; and an extension portion, disposed within the neck body, wherein the extension portion projects from the neck body and the maximum internal diameter of the extension portion is greater than the maximum internal diameter of the neck body.

[021] In some embodiments, when the extruded neck portion is attached to the inlet adapter of a blood pump, the extension portion snugly embraces the inlet adapter and the neck body is arranged around the inlet adapter.

[022] In some embodiments, the aortic adapter assembly further comprises a coupler, wherein the coupler includes: a flange base; a pair of collars, wherein the flange base is mounted on the collars; and a lock, which may lock the collars; wherein the collars have internal grooves which may hold the T-shaped flow connector with controlled compression to seal the T-shaped flow connector.

[023] In some embodiments, each of the collars has a flange contour that allows simultaneous engagement of the collars with respect to a ring on the base of the flange.

[024] In some forms, the lock is made from a spring of Petition 870260041021, dated 04 / 05 / 2026, page 22 / 142 8 / 62 blade that ensures the coupler is locked without worrying about accidental loosening.

[025] In some embodiments, the coupler additionally includes a hinge joint disposed at the base of the flange and the collars are articulated to the hinge joint and rotate to the hinge joint and to the base of the flange.

[026] In some embodiments, the hinge joint is located on the first side of the flange base and the latch is located on a second side of the flange base, wherein the second side is opposite the first side.

[027] In some models, the lock is made of a leaf spring and has a slot in the middle that is able to lock onto the ramp without the need to disengage.

[028] In some embodiments, the base of the flange has a substantially circular structure and each collar has an arc-shaped structure.

[029] Another embodiment of the invention provides a blood pump device, for an implantable ventricular assist device, comprising the aforementioned aortic adapter assembly and a blood pump, wherein the blood pump has an inlet adapter, and the inlet adapter has a cone-shaped nozzle having the ability to fit the proximal end of the extruded neck portion.

[030] In some embodiments, the inner diameter of the blood collision inlet adapter is slightly larger than the inner diameter of the neck portion of the flow connector. BRIEF DESCRIPTION OF THE DRAWINGS

[031] Figure 1 is a schematic view of a para-aortic blood pump device according to a first embodiment of the present invention;

[032] Figure 2 is a schematic view of a para-aortic blood pump device according to a second embodiment of the present invention; Petition 870260041021, dated 04 / 05 / 2026, p. 23 / 142 9 / 62

[033] Figure 3 is a schematic view of a para-aortic blood pump device according to a third embodiment of the present invention;

[034] Figure 4 is a schematic view of a para-aortic blood pump device according to a fourth embodiment of the present invention;

[035] Figure 5 is a schematic view of a para-aortic blood pump device installed in the human body according to the first and second embodiments of the present invention;

[036] Figure 6 is a schematic view of a para-aortic blood pump device installed in the human body according to the third and fourth embodiments of the present invention;

[037] Figure 7 is a first schematic view of an actuator according to an exemplary embodiment of the present invention;

[038] Figure 8 is a second schematic view of an actuator according to an exemplary embodiment of the present invention;

[039] Figure 9 is a block diagram of the actuator functions and the main interconnecting signals that are required for the operation of the present invention;

[040] Figure 10 is a block diagram of the actuator functions and the main interconnection signals that are required for the operation of the third embodiment of the present invention;

[041] Figure 11 is a block diagram of the actuator functions and the main interconnection signals that are required for the operation of the second embodiment of the present invention;

[042] Figure 12 represents the actuator detection commands for the position of the electromechanical actuator (EMA) piston in relation to counterpulse pumping;

[043] Figure 13A is a perspective view showing a para-aortic blood pump implant according to the first or third modality. Petition 870260041021, dated 04 / 05 / 2026, p. 24 / 142 10 / 62 of this invention;

[044] Figure 13B is a cross-sectional view showing a para-aortic blood pump implant according to the first or third embodiment of the present invention;

[045] Figure 14A is a perspective view showing a para-aortic blood pump implant according to the second or fourth embodiment of the present invention;

[046] Figure 14B is a cross-sectional view showing a para-aortic blood pump implant according to the second or fourth embodiment of the present invention;

[047] Figure 15 shows the connection of the transmission line to the blood pump housing being made through a passage in the distal casing according to another embodiment of the present invention;

[048] Figure 16 shows a cross-sectional view of the blood pump illustrated in Figure 15;

[049] Figure 17 shows a surface groove design for extending the electrical wires from the passage located in the distal housing to the pressure sensing chamber in the proximal housing;

[050] Figure 18A shows a surgical end-to-side anastomosis of the present invention with a blood pump to an artery through the use of an interface adapter coupling;

[051] Figure 18B shows the coupling of the present blood pump to an artery by means of an insertion-type connection method using a T-shaped endovascular connector coupled by an interface adapter;

[052] Figure 19 illustrates a cross-sectional view of the body of revolution of an integrated blood bag and rod assembly with an axially symmetrical oval shape, including a bag, a proximal rod and a distal rod;

[053] Figure 20 is an exploded view showing the components used to construct the axially symmetrical oval-shaped rod and blood bag assembly (note that the bag is in its original shape before Petition 870260041021, dated 04 / 05 / 2026, page 25 / 142 11 / 62 of the integration of the connection to the proximal and distal rods illustrated in Figure 19);

[054] Figure 21 illustrates the configuration of the curved trilobed bag (proper mode) at the blood bag ejection end illustrated in Figure 19;

[055] Figure 22 represents a perspective view of the transmission line connected to the proximal housing of the blood pump through the passage;

[056] Figure 23A illustrates a cross-sectional view of the blood pump and the distal portion of the transmission line taken along section AA in Figure 6;

[057] Figure 23B shows a cross-sectional view of the proximal end of the transmission line taken along section AA in Figure 22;

[058] Figure 24 shows a cross-sectional view of a ventilation port installed in the proximal enclosure corresponding to the first modality;

[059] Figure 25A shows a cross-sectional view of a pressure sensing chamber and a passage in the proximal enclosure of the first embodiment. Note that the transmission line is not mounted and the passage comprises a first portion, an extension of the proximal enclosure and a second portion that is interconnected with the first portion;

[060] Figure 25B shows a perspective view of a microelectromechanical system (MEMS) pressure sensor incorporated in Figure 25A;

[061] Figure 26 shows a perspective view of a multilayer transmission line of the present invention, which includes inner tubes for transporting pneumatic air, intermediate tubes for transducing electrical signals, as well as coils, tethers and outer tubes;

[062] Figure 27 shows a cross-sectional view of a multiluminal transmission line design option;

[063] Figure 28A shows a typical view of the flow characteristics in the pump loading phase;

[064] Figure 28B shows a typical view of the flow characteristics in the pump ejection phase;

[065] Figure 29 is a perspective view of the present embodiment of the T-shaped aortic adapter; Petition 870260041021, dated 04 / 05 / 2026, page 26 / 142 12 / 62

[066] Figure 30 is a cross-sectional view of the present embodiment of the T-shaped aortic adapter;

[067] Figure 31 is an enlarged two-dimensional illustration of the embedded Nitinol lattice;

[068] Figure 32 defines the lateral stiffness (LS) used in the measurement of the conduit embedded in the Nitinol truss of the T-shaped aortic adapter;

[069] Figure 33 shows an exploded view of the parts included in the coupler;

[070] Figure 34A shows an integrated view of the coupler in the open configuration;

[071] Figure 34B shows an integrated view of the coupler in the locked configuration;

[072] Figure 35 is a cross-sectional view of the aortic adapter integrated into a para-aortic blood pump using the coupler;

[073] Figure 36A represents a stepped discontinuity generated by the butt joint method;

[074] Figure 36B represents a gap discontinuity generated by the butt joint method;

[075] Figure 37 shows a perspective view of an inlet adapter to be installed at the distal end of a para-aortic blood pump;

[076] Figure 38 shows a cross-sectional view of an inlet adapter to be installed at the distal end of a para-aortic blood pump;

[077] Figure 39 shows a sunken tip of the inlet adapter connected to the ramp surface on the neck of the T-shaped aortic adapter;

[078] Figure 40 represents a perspective view of a corrugated aortic adapter packaged in a wire-constraint delivery configuration;

[079] Figure 41A depicts a packaged aortic adapter being inserted midway through an access hole created in the aortic wall;

[080] Figure 41B depicts a packaged aortic adapter fully inserted into the aortic lumen;

[081] Figure 41C depicts a repositioned packaged aortic adapter. Petition 870260041021, dated 04 / 05 / 2026, page 27 / 142 13 / 62 with its T-shaped neck facing the aortic access orifice;

[082] Figure 41D depicts an expanded and implanted aortic adapter with its T-neck protruding from the aortic access orifice after wire release; and

[083] Figure 42 describes the step-by-step instructions for implanting the aortic adapter into a target aortic segment and connecting it to a blood pump. DESCRIPTION OF PREFERRED OPTIONS

[084] There are four embodiments that can be employed to carry out the present para-aortic blood pump invention, as described below.

[085] With reference to Figure 1 for the schematic view of a para-aortic blood pump device according to the first embodiment of the present invention, the para-aortic blood pump device 10 comprises: a blood pump 12, an aortic adapter 14, a transmission line 16 and an actuator 18. The blood pump 12 further comprises a pump housing and a pressure sensor. The blood pump housing consists of two chambers, one for blood storage and the other for receiving circulating air. These two chambers are separated by a flexible oval-shaped membrane suspended by a pair of strain relief rods fixed to the pump housing.The pressure sensor is installed in the pump housing to monitor blood pressure within the blood pump 12 to generate an electrical blood pressure signal. The aortic adapter 14 is a valveless, T-shaped manifold flow communicator coupled to the blood pump 12 and the human aorta. In the first embodiment, the aortic adapter 14 and the blood pump 12 are integrally formed, and the aortic adapter 14 is provided to connect the blood pump 12 to the human aorta. The aortic adapter 14 is manufactured from flexible materials, allowing the aortic adapter 14 to be deformed during insertion from a hole made in the aortic wall. This aortic adapter conduit, once inserted, is self-expanding and strong enough to withstand the radial compression exerted by the adapter. Petition 870260041021, dated 04 / 05 / 2026, page 28 / 142 14 / 62 oversized to the contacted aortic lumen. Transmission line 16 is coupled to the blood pump housing 12 to provide a pressure pulse to the blood pump 12 and transmit the electrical blood pressure signal received from the pressure sensor. Actuator 18 is coupled to transmission line 16 to receive the detected arterial pressure electrical signal, and actuator 18 comprises an electromechanical actuator to generate a pressure pulse according to the arterial pressure electrical signal and provides a regulated pressure pulse to the blood pump 12 via transmission line 16. Wearable actuator 18 provides timed air pressure pulses synchronized with the heart rhythm to trigger and control the ejection and charging of the implanted blood pump 12.

[086] The actuator 18 comprises a battery power system 11 and a redundant battery power system (battery power systems 21, 31, 41 in Figures 2 to 4 and 8 are the same or similar), wherein the redundant battery power system ensures a continuous power supply to the actuator 18. Power may also be supplied to the actuator 18 by an AC adapter for the convenience of the device recipient when mobility is not required. In addition, a clinical monitor unit, not shown in Figures 2 to 4, may be connected to the actuator 18 to provide a user interface to the physician to display monitoring or diagnostic information from the device and to access the actuator parameters in order to initiate and optimize a patient-specific operating mode setting.

[087] Figures 1 and 2 illustrate two different blood pump designs 12, 22 coupled to the same transmission line 16, 26 and actuator 18, 28.Figure 2 is a schematic view of a para-aortic blood pump device 20 according to the second embodiment of the present invention, and the difference between the second embodiment and the first embodiment of the present invention lies in the fact that the para-aortic blood pump device 20 of the second embodiment additionally comprises a coupler (or coupling adapter) 25. The blood pump 22 and the aortic adapter 24 of the second. Petition 870260041021, dated 04 / 05 / 2026, page 29 / 142 The 15 / 62 models are not integral but are detachable from each other; and the coupler 25 is provided to couple the blood pump 22 to the aortic adapter 24. Care must be taken in the design of the coupler to minimize interface discontinuity around the connected region. During device implantation, the aortic adapter 24 is first inserted into the aorta through an access hole made in the aortic wall. Using specially developed implantation tools, a coupling adapter 25 is positioned around the protruding neck of the aortic adapter 24, to which the blood pump 22 can be connected. After the blood pump 22 is introduced into the thoracic cavity, the blood pump 22 and the aortic adapter 24 are firmly integrated using the coupler 25. Such a detachable design of blood pump 22 and aortic adapter 24 encompasses surgical and postoperative advantages.During device implantation, the detachable pump design facilitates insertion of the aortic adapter because the surgical field is clearer without interference from the pump body. Furthermore, in the postoperative period, the blood pump can be detached and replaced in case of pressure sensor malfunction or rupture of the blood bag requiring emergency surgical replacement. The detachable blood pump design of the second type is advantageous in this respect. The aortic adapter can remain in the aorta without explantation, avoiding the uncomfortable and risky re-surgery associated with aortic adapter removal.

[088] With reference to Figures 1 and 3 for schematic views of the para-aortic blood pump devices 10, 30 according to the first and third embodiments of the present invention, respectively, the difference between the third embodiment and the first embodiment of the present invention lies in this: the transmission line 16 of the first embodiment is replaced by the transmission line 36 including the distal transmission line 37, the transmission line interconnector 33 and the proximal transmission line 39 of the third embodiment. The distal transmission line 37 is coupled to the transmission line interconnector 33 to transmit the acquired arterial pressure electrical signal from Petition 870260041021, dated 04 / 05 / 2026, p. 30 / 142 The pressure sensor 16 / 62 and the pressure pulse sent from actuator 38; and the transmission controller and vibrator (for alarm warning purposes) included in transmission line interconnect 33 are originally included in actuator 18 of the first mode, so that actuator 18 of the first mode has the additional transmission controller and vibrator (compared to actuator 38 of the third mode). The transmission line controller is used to process the electrical blood pressure signal and the vibrator is used to provide an audible alarm or tactile feedback.In other words, the transmission of mechanical energy to charge and eject the blood pump and the analog / digital signal conversion and alarm announcement, achieved respectively by transmission line 16 and actuator 18 of the first mode, are substantially the same as those by distal transmission line 37, transmission line interconnector 33 and proximal transmission line 39 of the third mode.

[089] The first model has a cleaner transmission configuration and features an electronic signal processor in the actuator, thus minimizing the risk of environmental contamination (water ingress or moisture condensation) of the detected pressure signal and air leakage occurring at the joint, both associated with the interconnector transmission 33. However, this long transmission line is more vulnerable to contact damage, such as wear, bends, cuts, and abrasion resulting from contact with foreign objects in daily activities. Any major damage to the transmission line 16 of the first or second model, whether electronic or mechanical, may justify surgical replacement of the blood pump, which is highly undesirable given the risk of re-surgery and the associated medical costs.The third or fourth method, using an intermediate connector (transmission line interconnector), mitigates this disadvantage of blood pump replacement related to transmission line damage. In general, the length of the externalized distal transmission line 37 is short and the interconnector 33 is better protected by the patient's skin dressing and / or vest covering. Petition 870260041021, dated 04 / 05 / 2026, page 31 / 142 17 / 62 In the extreme case of severe damage to the transmission line that is beyond repair, the most likely damaged proximal transmission line 39 can be easily replaced without resorting to surgery. Furthermore, the third or fourth mode is more immune to electromagnetic interference because the analog-to-digital signal conversion is already performed in the interconnector circuits 33. The fidelity of the pressure signals can be better ensured in the third or fourth mode because the digital signal transmission on the proximal transmission line 39 is less susceptible to electromagnetic interference.

[090] With reference to Figures 3 and 4 for schematic views of the para-aortic blood pump device 30, 40 according to the third and fourth embodiments of the present invention, respectively, the difference between the third embodiment and the fourth embodiment lies in the fact that the aortic adapter 34 and the blood pump 32 of the third embodiment are integrally formed; whereas the blood pump 42 and the aortic adapter 44 of the fourth embodiment are detachable; and the fourth embodiment further comprises a blood pump 42, an aortic adapter 44 and a coupler 45 which are the same as the blood pump 22, the aortic adapter 24 and the coupler 25 of the second embodiment and therefore their descriptions will not be repeated.Transmission line 46, including distal transmission line 47, transmission line interconnector 43, and proximal transmission line 49 of the fourth mode, is the same as transmission line 36, including distal transmission line 37, transmission line interconnector 33, and proximal transmission line 39 of the third mode.

[091] With reference to Figure 5 for a schematic view of a para-aortic blood pump device installed in the human body according to an exemplary embodiment of the present invention, the para-aortic blood pump device 90 comprises a blood pump 92, an aortic adapter 94, an internal transmission line 991, an external transmission line 993 and an actuator 98. In another embodiment, the para-aortic blood pump device further comprises a coupler. A Petition 870260041021, dated 04 / 05 / 2026, p. 32 / 142 Part 18 / 62 of the para-aortic blood pump device 90 implanted in the human body includes the blood pump 92, the aortic adapter 94, and the internal transmission line 991. In another embodiment, the para-aortic blood pump additionally comprises a coupler. After a surgical operation, the aortic adapter 94 is installed in an aorta 95, and an EX outlet site is created in an appropriate position on the epidermis of the human body. The part of the para-aortic blood pump device 90 located outside the human body includes the external transmission line 993 and the actuator 98. The EX outlet site is used as a boundary, and the internal transmission line 991 has a segment covered by a velvety tissue for internal tissue growth to achieve infection control. The implanted velvet portion is placed 2-5 cm subcutaneously from the EX outlet site. The actuator 98 is a portable or wearable device.

[092] With reference to Figure 6 for the schematic view of a para-aortic blood pump device installed in the human body according to an exemplary embodiment of the present invention, the para-aortic blood pump device 90 comprises a blood pump 92, an aortic adapter 94, a distal transmission line 97 (including an internal distal transmission line 971, an external distal transmission line 973 outside the human body), a transmission line interconnector 93, a proximal transmission line 99 and an actuator 98. In another embodiment, the para-aortic blood pump device 90 further comprises 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 internal distal transmission line 971. In another embodiment, the para-aortic blood pump device additionally comprises a coupler.Following a surgical operation, the aortic adapter 94 is installed in an aorta 95 and an EX outlet site is created in an appropriate position on the human body's epidermis. The part of the para-aortic blood pump device 90 located outside the human body includes a transmission line. Petition 870260041021, dated 04 / 05 / 2026, page 33 / 142 19 / 62 external distal 973, a transmission line interconnector 93, a proximal transmission line 99, and an actuator 98. The EX exit location is used as a boundary, and the distal transmission line is divided into an internal distal transmission line 971, covered with velvet for infection control, and an external distal transmission line 973. The actuator 98 is a portable or wearable device.

[093] The implant subsystem is described further below.

[094] Implantation is achieved through a relatively small thoracic opening, using minimally invasive surgical techniques via a left thoracotomy. A thoracic incision is made, for example, in the 7th intercostal space as the primary opening to allow placement of the aortic adapter and blood pump. Two other small incisions are made in the 6th and 8th intercostal spaces, respectively, for the introduction of proximal and distal aortic cross clamps. The clamped aortic segment allows the aortic adapter to be inserted into the implant site through an overbore created in the aortic wall. The aortic adapter is flexible and can be bent and restrained into a smaller delivery configuration before insertion. After completion of insertion into the aorta, the corrugated aortic adapter must be released and restored to its original shape with a predetermined size relative to the diameter of the implant site lumen.The material of the aortic adapter is therefore important; it must be flexible but exhibit sufficient radial strength to ensure that the delivered adapter conduit remains circular without warping the wall. Candidate aortic adapter constructions may include those made from silicone or polyurethane elastomers, or those reinforced polymer constructions with added materials.

[095] The functional requirements of the aortic adapter for each of the above-mentioned modalities are described below.

[096] Hemodynamically, the aortic adapter plays a flow communication role between the blood pump and the systemic circulation. Petition 870260041021, dated 04 / 05 / 2026, page 34 / 142 20 / 62 human. In addition to this function, the aortic adapter also serves as a mechanical base to hold the blood pump in place when connected to the aortic adapter. The structure of the aortic adapter must be elastic, yet resistant to torsion, and strong enough to withstand internal blood pressure and external contact forces exerted through contact with the surrounding lung tissue or diaphragm associated with respiratory and thoracic movement.

[097] The aortic adapter 54 is implanted within the aorta with its two conduit ends 545, 645 interconnected with the aortic lumen forming a host / graft boundary in the bloodstream. In order to minimize discontinuity of the host / graft interface, both morphologically and elastically, the two ends of the conduit 545, 645 are configured to have a gradually widened internal surface profile and a continuously reduced wall thickness distribution. Such a conduit end design minimizes the step at the interface, as well as constituting a conformal matching effect to unite the aortic adapter to the aortic lumen. The thrombus at the interface can thus be annihilated as the rate of clot aggregation at the interface is slower than the natural rate of thrombolysis provided by the endothelium.Furthermore, the gradually thinner conduit wall structure makes the conduit ends 545, 645 softer (compatible), which allows the ends to expand and contract in conjunction with pulsatile blood pressure, constituting a dynamic sealing effect to prevent blood from becoming trapped in the joint interface space that is often the origin of thrombus formation.

[098] The actuator for each of the above-mentioned modes is described below.

[099] Illustrated in Figures 7 and 8 are perspective views of the right and left sides of actuator 78. This compact actuator 78 contains internal modules including an electromechanical actuator (EMA), an electronic controller, a main battery pair and a backup battery. This actuator 78 Petition 870260041021, dated 04 / 05 / 2026, page 35 / 142 21 / 62 also comprises external modules of a user interface panel 73, a battery access door 71, a transmission receptacle 75, an AC receptacle 77 and a pair of ventilation windows 79, as shown in Figures 7 and 8.

[100] Critical operating information and alarm warnings for device malfunctions and aortic pressure conditions will be displayed on the user interface panel 73 of the actuator 78. The primary battery can be replaced via the battery access port 71 when the primary battery power is depleted. An electrical cable is used to power the actuator 78 via a connection through the AC receptacle 77 when the patient is bedridden, and wall outlet power can be used long-term. The proximal transmission line end 99, 993 is connected to the actuator 78 via the transmission line receptacle 75, through which both the electrical sensor signal and the pneumatic pressure pulse are communicated. A pair of ventilation windows 79 are installed on opposite sides of the actuator 78 to allow ambient air to flow through the interior of the actuator 78 for cooling purposes.

[101] The 78 actuator can be externally coupled to a clinical monitor, wherein the clinical monitor is provided to collect and display real-time clinical waveform data and store patient data for long-term condition monitoring and diagnosis. In addition, a clinical monitor unit provides a user interface to the physician to display device monitoring / diagnostic information and to access actuator parameter settings in order to initiate and optimize a patient-specific operating mode.

[102] The EMA is a pneumatic actuator consisting of a brushless servo motor, a ball screw drive, a piston and a cylinder assembly. Atmospheric air is used as the driving medium to eject and reciprocally charge the blood pump.

[103] The EMA module is housed in the actuator carried by the receiver of Petition 870260041021, dated 04 / 05 / 2026, page 36 / 142 22 / 62 implant. The EMA consists of a brushless servo motor, a piston and cylinder assembly, and a ball screw unit comprising a ball screw rod and a nut. The piston is firmly mounted on top of the ball screw rod, which is in rotary coupling with the nut of the ball screw unit. The servo motor includes a stator and a rotor, and the rotor is integrated into the nut of the ball screw unit. Through the electromagnetic coupling of the rotor / stator induction, the rotor can be rotated clockwise and counterclockwise, thus driving the ball screw rod forward and backward in a straight line to result in a reciprocating motion of the piston stroke in a cylinder.Atmospheric air is used as the actuation medium, where the alternating stroke of the piston compresses and releases air from inside the cylinder, thus generating alternating pressure pulses transmitted through a transmission line to the implanted blood pump for ejection and filling actions.

[104] There are two air conduction problems associated with the current design of the EMA pneumatic actuator; namely, air leakage and condensation of water vapor permeated by blood through the wall of the blood bag. The former will impair the pump's ejection and loading function and the actuator's energy consumption, leading to degradation of the support's effectiveness, and the latter will cause a risk of bacterial invasion inside the transmission line. To solve these two problems, the present EMA incorporates a pressure equalizing valve installed in the cylinder chamber wall for air replenishment and humidity reduction. The pressure equalizing valve is opened periodically at a predetermined frequency, allowing the transport of air mass between the cylinder and the environment until the air pressure in the cylinder chamber equals atmospheric pressure.The EMA incorporates optical and position sensors to acquire reference trajectory signals for the electronic controller to generate coordinated control commands to actuate the piston stroke movement, as well as to operate the pressure equalization valve. Consequently, the time and frequency for the valve... Petition 870260041021, dated 04 / 05 / 2026, page 37 / 142 23 / 62 pressure equalization can be activated for air exchange and can be programmed into the controller. With this built-in pressure equalization valve, the drive air medium can be kept constantly full and dry in the pneumatic actuator to ensure safe and effective long-term pumping support of the blood pump.

[105] As illustrated in Figure 11, a para-aortic blood pump device according to an embodiment of the present invention is divided into three portions. The first portion is largely installed inside the human body (which is an implant) with an exteriorized end to communicate with the second portion; and the first portion comprises a blood pump (including a blood pump pressure sensor), an aortic adapter, and distal transmission segments disposed inside and outside the human body, respectively. The second portion is installed outside the human body and comprises a proximal transmission line and an electronic transmission line module (or known as a transmission line interconnector). The third part is installed outside the human body, which is an actuator composed of an electromechanical actuator (EMA), a control circuit, a main battery, and a backup battery.

[106] The blood pump pressure sensor is integrated into the proximal housing of the blood pump and immersed in a small pressure sensing chamber filled with sensing medium, allowing continuous monitoring of the blood pump pressure. A distal transmission line is attached to the pump housing and provides timed air pressure pulses to command the ejection and loading of the blood bag. The distal and proximal transmission lines provide a pneumatically actuated pressure pulse, generated by the EMA within the actuator, to the blood pump; and transmit an electrical blood pressure signal, generated by the blood pump pressure sensor, to the actuator. An actuation air path (indicated by a dashed arrow line) and an electrical signal path (indicated by a solid line) are illustrated in Figure 11 for Petition 870260041021, dated 04 / 05 / 2026, page 38 / 142 24 / 62 describe the functional relationship between the interacting modules. The detailed content of the aortic adapter was described above. The control circuit may include a motor controller unit to drive the brushless motor and a microcontroller unit as a central processor to process the received pressure signal and generate control commands for the motor controller to drive the piston movement.

[107] With reference to Figures 9, 10 and 11, a block diagram of the internal functions of the actuator and the main interconnection signals required to drive the blood pump is shown. The embossed embodiments of the present invention are further described, as illustrated in Figures 12 and 13. To explain the drive relationship between the external actuator and the implant, it is necessary to refer to the aforementioned contents of the blood pump, transmission line, distal transmission line, proximal transmission line, aortic adapter and transmission line interconnector.

[108] The actuator receives the blood pump pressure signal (electrical signal) and processes the signal using the actuator detection algorithm to generate the trigger signal that commands the actuation of the EMA in synchronization with the heart rhythm. Upon receiving the assigned actuator time, the microcontroller unit sends commands to the motor controller unit to actuate the piston, from ejection to loading or from loading to ejection strokes, to provide counterpulsatile circulatory support.

[109] The electronic controller architecture incorporates three functional blocks, namely, a microcontroller unit (MCU), a motor control block (motor controller unit), and a power management unit. The following table provides detailed descriptions for each functional block of the 78 drive. Job Title Description Petition 870260041021, dated 04 / 05 / 2026, page 39 / 142 25 / 62 Microcontroller Unit (MCU) 130 The MCU processes blood pump pressure and generates a trigger that synchronizes the device's pumping with the left ventricle. According to the trigger timing, the MCU sends motor commands to the motor controller to actuate the piston from the eject-to-load or load-to-eject positions, according to the treatment management settings. It also manages system data storage, system condition monitoring and alarms, commands sent from the Clinical Monitor, and the patient user interface (LCD screen, LED indicators, and audible alarms). Motor Controller Unit 120 Motor controller unit, a motor servo control system that responds to serial commands from the MCU to actuate the motor with specified parameters of position, speed, and acceleration.Electromechanical Actuator (EMA) 110 The EMA actuates the piston within a cylinder via a brushless servomotor to provide pulsatile pressure to the blood pump. Blood Pressure Sensor 527 The blood pressure signal is obtained from the blood pressure sensor element incorporated into the implanted blood pump. The blood pressure signal provides the pressure waveform for the MCU to process and determine the timing to command the EMA ejection and charging action. User Interface Panel 170 Provides LED indicators, audible alarm, buttons, and LCD screen. Power Management Circuit 140 The circuit serves to manage the system's power, including power switching, battery condition monitoring, and load control. Attached Battery 150 Provides power to the system when it is not supported by external power.The Clinical Monitor 190 collects and displays real-time waveform data from the device; initiates trigger parameter configuration and stores patient identification data; performs long-term condition monitoring and diagnostic trend analysis.

[110] Acquisition, transmission, signal processing and control logic Petition 870260041021, dated 04 / 05 / 2026, page 40 / 142 26 / 62 and the generation of command signals and EMA actuation to produce a pressure pulse to trigger the blood pump, refer to the functional responsibilities of the MCU within this controller architecture, as summarized in the table above. These functions are conceptually illustrated in Figure 12 as the time relationship between the aortic pressure waveform, the piston trajectory, and the trigger signals (F_Trig and E_Trig) generated by the MCU, which demonstrate the operation of the control logic rather than detailed electronic circuits for the previously elucidated modalities.

[111] Figures 14a and 14b represent the actuator detection commands for the EMA piston position relative to counterpulsatile pumping. These figures schematically illustrate the coordination between piston movement, generated pressure pulses, and blood pump response during the systolic and diastolic phases. When the actuator operates in Auto Run mode, actuator operation is initiated and the system performs a cyclical “load-eject-load-eject…” pumping, which represents normal synchronous counterpulsation operation. The MCU monitors blood pump pressure (BPP) signals (electrical signal) and detects the left ventricular end-diastolic time (LVED). After detecting LVED timing, the MCU generates an F_Trig signal. The time interval between two consecutive F_Trig signals represents an instantaneous interval (or period) of the cardiac cycle.Based on an estimated heart rate calculated from the intervals of the previous cycle, the MCU determines the timing, the E_Trig signal, for the ejection of the blood pump. The E_Trig signal provides the time to command the motor control unit to activate the EMA according to predetermined profiles of position, speed, and acceleration. When the ejection stroke is completed and after an optimized dwell time, the EMA is commanded to perform a pre-loading action with a smooth loading speed until the F_Trig signal appears. Upon receiving the F_Trig signal, the EMA begins to perform a residual loading stroke at a specified piston speed. Petition 870260041021, dated 04 / 05 / 2026, page 41 / 142 27 / 62

[112] When the MCU loses the BPP signal (electrical signal) sent by the blood pump, a flushing mode is automatically initiated by the MCU to drive the EMA, operating at a predetermined pumping rate and stroke volume of the trigger. The flushing mode is used to prevent thrombus formation in the blood bag, which is a device protection mode rather than providing synchronous circulatory support.

[113] The para-aortic blood pump device of the present invention, with its non-occlusive para-aortic feature, in principle has better counterpulsatile support efficacy compared to the intra-aortic balloon pump (IABP). Unlike bedridden or ambulatory IABP patients who need to remain in the hospital, the portable para-aortic blood pump device allows patients to leave the hospital and have ambulatory capabilities to live a better life at home. Consequently, the para-aortic blood pump device of the present invention can further improve the patient's disease conditions and quality of life, in addition to the economic benefits obtained with a shorter hospital stay.

[114] The trend of LVAD use has stabilized in recent years, mainly because its application is indicated only for the cohort of patients with end-stage heart failure. The application of early LVAD intervention therapy to less ill heart failure patients has been a clinical goal, which should have a substantial impact on the future advancement of cardiac medicine provided by the expanded use of LVAD therapy. Clinical evidence has demonstrated that certain patients with non-ischemic cardiomyopathy supported by LVAD, administered at the stage of moderate to severe heart failure, can be improved with reverse myocardial remodeling towards functional upgrade or sustained myocardial recovery. However, this intention of early intervention must be driven by two facilitating factors: an easy and safe surgical procedure and an effective and adaptive support scheme that Petition 870260041021, dated 04 / 05 / 2026, page 42 / 142 28 / 62 monitor the disease progression. Continuous flow VAD support is not physiological, which diverts the supported heart from a normal course of recovery. Counterpulsatile support, however, is physiological and meets therapeutic requirements, providing systolic contraction discharge and increased diastolic perfusion to promote reverse remodeling of myocytes. In summary, the treatment strategy provided by this para-aortic blood pump invention aligns with the developing trend of early intervention in cardiac medicine. Beneficial attributes provided by the para-aortic blood pump device, such as adaptive partial support, less invasive surgery, and counterpulsatile therapy, will collectively make the present invention a potential candidate to contribute to the future advancement of heart failure treatment.

[115] The blood pump for each of the above-mentioned modalities is described below.

[116] With reference to Figures 13A and 13B for the schematic and cross-sectional view of a part of a para-aortic blood pump device installed in the human body according to the first and third embodiments of the present invention, the implant subsystem of the para-aortic blood pump device comprises the blood cone 52, the aortic adapter 54 and the transmission line (or distal transmission line) 57 attached to the blood pump 52. The blood pump 52 comprises a rigid or semi-rigid pump housing 52h of the blood pump 52 and a blood bag 529 having its proximal end closed and its distal end open and perfectly integrated into the aortic adapter 54. The blood bag 529 is formed by an oval-shaped bag membrane 526, furthermore, the blood bag 529 is anchored through a proximal rod 530 to the proximal casing 523 of the pump housing 52h and through a distal rod 540 to the distal casing 525 of the pump body 52h.The space in the blood pump is divided into a blood chamber B and an air chamber A separated by the flexible oval-shaped bag membrane 526 suspended by a pair of strain relief rods (proximal rod). Petition 870260041021, dated 04 / 05 / 2026, p. 43 / 142 29 / 62 530, distal rod 540) fixed to the pump housing 52h. The blood chamber B is for blood storage and the air chamber A is for receiving actuation air. The pump housing 52h comprises the proximal housing 523 in which a pressure sensor (or blood pressure sensor) 527 is hermetically embedded, and the detected pump pressure is transmitted through the bag membrane 526, propagated in an incompressible liquid in a closed pressure sensing chamber 528 and finally received by the pressure sensor 527. After receiving the detected pump pressure, the pressure sensor 527 generates an electrical blood pressure signal. The components of the implanted subsystem are designed with a size and shape that can be implanted in patients with a body surface area (BSA) of 1.2 m2 or greater.

[117] With reference to Figures 14A and 14B for the schematic and cross-sectional view of a part of a para-aortic blood pump device installed in the human body according to the second and fourth embodiments of the present invention, the implant subsystem of the para-aortic blood pump device comprises the blood pump 62, the aortic adapter 64, the coupler 65 and the transmission line (or distal transmission line) 67 connected to the blood pump 62. The coupler 65 is used to couple the blood pump 62 to the aortic adapter 64 to access the recipient's vascular system. The blood pump 62 comprises a pump housing 62h, which further comprises a proximal casing 623 and a distal casing 625. The construction of the present blood pump 62 is similar to that disclosed in Figure 13B, except that the distal opening OP is separate and independent of the aortic adapter. The coupler 65 is placed around the flexible neck 643 of the aortic adapter 64.Next, the design revealed in Figure 13B was used to better explain the blood pump design and the underlying design logic.

[118] Referring to Figure 13B, the blood pump 52 comprises a molded rigid or semi-rigid blood housing 52h which further comprises a proximal casing 523 and a distal casing 525. O. Petition 870260041021, dated 04 / 05 / 2026, p. 44 / 142 The 30 / 62 housing 52h has a single OP opening connected to the aortic adapter 54 to access the recipient's vascular system. The OP opening of the blood pump 52 is manufactured seamlessly together with the aortic adapter 54 (or the blood pump 52 and the aortic adapter 54 are integrally formed), which provides a smooth and continuous interface transition to the neck of the aortic adapter 54. This integrated blood bag 529 and aortic adapter 54 assembly is attached to the proximal housing of the pump 523 and the distal housing 525 via a connection to the proximal stem 530 and the distal stem 540, respectively. The blood bag 529 is anchored to the top of the proximal housing 523, so that a small non-flexible circular portion of the blood bag 529 is disposed close to a pressure sensing chamber 528 in the housing 523.

[119] A miniaturized pressure sensor 527 is built into the pump housing 523 and the fluid is communicated to the closed pressure sensing chamber 528.This arrangement allows for continuous monitoring of the blood pressure contained in the blood bag 529. As the pressure sensor 527 does not come into contact with the blood, the long-term reliability and accuracy of the sensor are ensured by the protection of the pump housing 52h, which isolates the sensor 527 and its electrical circuit from the influence of chemical corrosion and protein adhesion resulting from direct contact with blood.

[120] One end of the transmission line 57 is fixed to the pump casing 525 to provide timed air pressure pulses to drive the ejection stroke or loading of blood out of or into the blood pump 52. The transmission design may be multiluminal or multilayer to accommodate the electrical wires for pressure signal transmission. Metal coil or fabric mesh may be adopted as wall reinforcement to increase the anti-torsion capacity of the transmission line 57. The overall geometry of the blood flow passage in the present blood pump is wide, together with the valveless aortic adapter design and pulsatile pumping operation, constituting a superior blood handling property that avoids high shear-induced hemolysis. Petition 870260041021, dated 04 / 05 / 2026, page 45 / 142 31 / 62 as well as the formation of thrombi generated at low flow velocity or thromboembolism.

[121] The blood bag 529 of the blood pump 52 includes an innovative design to make the bag membrane 526 durable. The blood bag 529 is an oval-shaped membrane body that rotates towards the centerline of the blood pump 52. There are two polymeric rods (proximal rod 530, distal rod 540) attached at both ends of the housing 52h, configured respectively to have a circular disc or an annular shape, and functioning as a bend / stretch relief mechanism to relieve stress concentration when attached to the rigid housing 52h. During pump ejection, the bag membrane 526 will be compressed or bent into a trilobular shape, where the highest stress often occurs at the creased bend line near the edge of the rod attachment (proximal rod 530, distal rod 540).This high local membrane stress / strain resulting from the large membrane deformation is substantially reduced or absorbed by the deformation of the flexible rod rim as a flexible suspension. Note that the trilobular folding pattern is not stationary, with creases shifting from place to place as influenced by the gravitational direction. In fact, a patient's posture and body orientation, including standing, sleeping, sitting, exercising positions, etc., can change from time to time during daily activities. The gravitational effect or body force acting on the blood volume stored in the blood pump 52 is therefore constantly changing, resulting in the initiation and formation of a non-stationary crease line. This membrane folding line constitutes a unique fatigue resistance feature of the present invention.The present blood pump 52 is expected to have a much longer lifespan than that of the conventional membrane design with a fixed bending line.

[122] The folding and expansion of the membrane are closely related to the vortex flow pattern contained in the blood bag 529. The Petition 870260041021, dated 04 / 05 / 2026, p. 46 / 142 The 32 / 62 design of the aforementioned pump features a continuous folding line formation that causes the vortex structure pattern to alternately change in response to the folded membrane pattern. The washing effect in the 52 blood pump is therefore strong and non-stationary, characterized by a vortex flow movement similar to a random walk. Such randomness in the vortex flow structure of the pump helps to wash the entire blood contact surface without creating any fixed low-velocity zone near the membrane wall or in the fold area. It has been observed in animal tests that the present blood pump is very resistant to thrombi.

[123] The (distal) transmission line for each of the above-mentioned modes is further described below.

[124] With reference to Figures 5 and 6 for a schematic view of the transmission line used to connect the blood pump 92 to the actuator 98. The intracorporeal (distal) transmission line 991, 97 pneumatically connects the blood pump 92 to the electromechanical actuator housed within the actuator 98 and also carries the electrical signals acquired from the blood pump pressure sensor 527 (see Figure 13B). The (distal) transmission line 991, 97 has one end fixed to the blood pump housing and the opposite end has a small external connector for pneumatic and electrical communication. The (distal) transmission line 991, 97 is tunneled subcutaneously and exits from the skin. The outer diameter of the (distal) transmission line 991, 97 is designed to be small and the tubing material is flexible to minimize EX stress at the exit site for patient comfort.A portion of the (distal) transmission line 991, 971 is covered with a porous tissue to promote tissue growth, so as to make the exit site resistant to infection. The externalized (distal) transmission line 991, 973 is fixed a short distance beyond the skin exit site EX.

[125] The (distal) transmission line 991, 971 and its connector are designed Petition 870260041021, dated 04 / 05 / 2026, page 47 / 142 33 / 62 to withstand the tensile loads applied during surgical externalization. Post-operatively, the 991,971 (distal) transmission line is constantly influenced by loads induced by muscle movement, and the 991,971 (distal) transmission line is designed to withstand these loads during its intended service life. The externalized portion of the 991,971 (distal) transmission line is also designed to be biocompatible and chemically resistant to cleaning and disinfecting agents in clinical use.

[126] The (proximal) transmission line for each of the above-mentioned modes is further described below.

[127] Transmission line (proximal) 993, 99 is used to connect transmission line (distal) 991, 97 to the actuator 98. Transmission line (proximal) 99 has a transmission line interconnector 93 at one end and an actuator connector at the other end. Said transmission line interconnector 93 includes a circuit board, which converts the analog blood pump pressure signal into a digital signal, and a vibrator that provides tactile feedback in addition to audible alarms. Transmission line interconnector 93 has a flat shape to prevent twisting of the transmission line (distal) 973 when transmission line interconnector 93 is anchored against the patient's skin. In addition, transmission line interconnector 93 and the outer cover of the transmission line are designed to be sealed and protected against the ingress of water or moisture.Since the (proximal) 99 transmission line is installed externally, it can be replaced and / or maintained when deemed necessary, thus eliminating the need for surgical replacement of the blood pump when the (proximal) 99 transmission line is damaged or repairable.

[128] The valveless blood pump has two advantages in blood handling characteristics: 1) it does not produce an annoying valve sound and damage to blood cells induced by the valve, thrombus formation and thromboembolism; 2) it is more resistant to thrombi because the pulsatile flow Petition 870260041021, dated 04 / 05 / 2026, page 48 / 142 The 34 / 62 bidirectional design has a better surface cleaning effect to minimize protein adhesion and prevent clot formation related to interface discontinuity on artificial surfaces in contact with blood. The flow passage in a valveless pulsatile pump is uniformly much wider than in valved or rotary continuous-flow pulsatile pumps. Hemolysis (red blood cell membrane rupture) commonly occurs in narrow flow passages with a high flow velocity gradient, such as the spaces between the valve ring and the leaflet of a valved pulsatile pump. Furthermore, low-velocity recirculation or a stasis zone often exists behind the open valve, which can stimulate thrombus formation.In stark contrast, in a valveless pulsatile blood pump, the shear stress applied to blood cells is literally an order of magnitude lower, and the low-velocity stasis zone associated with valve geometry and movement is substantially eliminated, leading to less blood cell damage or platelet activation, less clot formation and aggregation, and resulting in lower doses of anticoagulant and easier, safer postoperative care.

[129] Figures 15 to 17 show the blood pump 62, the transmission line 67 and the passage 63 according to another embodiment of the present invention. This embodiment emphasizes anatomical adaptability for easier placement of the blood pump and externalization of the transmission line.

[130] As shown in Figures 15 and 16, the transmission line 67 is connected to the distal housing 625 of the blood pump 62. The blood pump 62 has the oval-shaped blood bag and rod assembly 650 (including the bag 629 and rods 630, 640), the pump housing 62h (which has the proximal housing 623 and the distal housing 625) and the pressure sensing system 628 embedded in the proximal housing 623. The design details of the oval-shaped blood bag and rod assembly 650, the distal housing adapter 6251, the pressure sensing system 628 and the line of Petition 870260041021, dated 04 / 05 / 2026, p. 49 / 142 35 / 62 transmission 67 are substantially identical or correspond to those of the aforementioned modality, and the modular and functional descriptions are not repeated in this document.

[131] In this embodiment, passage 63 is disposed in the distal housing 625 of the pump housing 62h to couple the transmission line 67 to the pump housing 62h. Furthermore, passage 63 is configured in a body-fitted format adjacent to the distal housing 625, making the transmission line connection tangential to the external surface of the pump. This body-fitted passage design makes the pump body design 62h adaptable to the anatomical space available for blood pump placement. The blood pump 62 can be rotatably connected to the interface adapter 501 and allow the transmission line 67 to be directed in the most suitable orientation to allow smooth subcutaneous tunneling and skin exit. In this way, it favors anatomical adaptability to the geometry of the implant site.

[132] In this embodiment, passage 63 is remotely fitted in the distal housing 625 while the pressure sensor 6271 (see Figure 25A) and the sensing chamber 628 are located in the proximal housing 623. Further engineering work has to be performed to separate the signal transduction route from the pneumatic communication route and to ensure that the blood pump 62 is sealed and protected against biochemical fluid intrusion that could impair signal transduction fidelity after device implantation.

[133] Figure 17 shows that the pump housing 62h has a surface groove 621 formed on the outer surface of the distal housing 625 and above an overlapping connection area DA (Figure 16) of the proximal housing 623 and the distal housing 625.The surface groove 621 is configured to allow electrical wires to be extended from the exit of the passage 63, along the groove above the overlapping connection area, and reach the electrodes 6274 of the pressure sensor 6273 (see Figure 25B). In some embodiments, the groove 621 is sealed by a waterproof material and / or a shaped cover. Petition 870260041021, dated 04 / 05 / 2026, page 50 / 142 36 / 62 ring to maintain a smooth outer surface so as not to irritate or injure the fabric in contact.

[134] As illustrated in Figures 18A and 18B, the aortic connector 50 generally requires an interface adapter 501 to serve as a coupling mechanism to connect the blood pump 62 to the target artery 60. The distal end 504 of the connector 50 opposite the interface adapter 501 is placed in the vascular wall of the artery 60 and in fluid connection with the human circulation. The proximal end (the interface adapter 501) of the aortic connector 50, however, has a smooth interface transition to geometrically match the inlet morphology of the blood pump 62. A coupler is normally required to integrate the proximal end of the connector 50 (the interface adapter 501) with the inlet of the blood pump 62. There are several modalities that can be used as an aortic connector 50.The one shown in Figure 18A is the end-to-side anastomosis of a Dacron or Polytetrafluoroethylene (PTFE) graft 502 sutured to the target vessel 60, which can be used in vascular surgery. In some other embodiments, such as that shown in Figure 18B, an insertion-type aortic connector 503 is used, such as the T-shaped collector adapter 503 disclosed in US Patent No. 2008 / 0300447A1, entitled “Dual-pulsation biventricular Assist Device.”

[135] Figures 19 and 20 illustrate, respectively, the assembly and components of the design of the axially symmetrical, long-lasting, oval-shaped blood bag and stem assembly 650. The polymeric material chosen for these components may be, but is not limited to, segmented polyurethane with various appropriate durometers. The constituent parts of the bag and stem assembly 650 include a flexible membrane bag (blood bag) 629, a proximal stem 630, and a distal stem 640, all of which are produced in axially symmetrical shapes and integrated together into a body of revolution assembly relative to a common centerline 62C of the blood pump 62. The proximal stem 630 is located at the end Petition 870260041021, dated 04 / 05 / 2026, page 51 / 142 37 / 62 proximal 6291 of pouch 629 and the distal rod 640 is located at the distal end 6292 of pouch 629.

[136] Figure 19 shows the integrated pouch and rod assembly 650, of which the distal rod end 640 is coiled and connected to the inverted membrane 62A at the distal end of the pouch 629. Figure 20 illustrates the constituent parts before bonding. In general, the pouch 629 is manufactured by dip molding while the rods 630, 640 are injection molded. There is no preferred azimuthal angle for the pouch deformation to be influenced. In theory, the thin-walled pouch constructed in an axially symmetrical oval shape will fold into a trilobular configuration 6293, as shown in Figure 21, when the pressure differential across the membrane exceeds a certain limit. Such membrane deformation only matters with the final trilobular configuration 6293 (proper mode) and where the creases 6294, or fold lines, will occur is decided by the initial perturbation that triggers the onset of deformation instability.The uniformity of thickness in the transverse planes cut perpendicularly to the central line (or axis of revolution) 62C of the blood pump assembly 62 is critical. Care must be taken to maintain high-precision bag manufacturing so that an axially symmetrical shape is ensured. In real-life application, the direction of gravity stands out as the dominant factor in initiating the folding line. The postures of the device recipients constantly change, as does the direction of gravity relative to the orientation of the blood pump, according to the patient's daily activities such as standing, sitting, exercising, sleeping, etc. The bag's deformation creases 6294 therefore appear in a pattern similar to a random walk that disperses the high-stress creases in a non-stationary manner across the entire bag.Avoiding permanent placement in high-voltage areas at fixed locations is therefore the main design guideline for making the bag long-lasting.

[137] The embodiment of the present invention innovates a continuous bending line attribute that causes the high voltage location to appear non Petition 870260041021, dated 04 / 05 / 2026, page 52 / 142 38 / 62 stationary membrane to extend the fatigue life of the bag. The detrimental phenomenon of stress concentration often associated with blood bag bending is therefore improved. Based on this fundamental change in the bending pattern behavior, the fatigue life of the membrane will increase significantly, attributable to this non-stationary bend line formation characteristic that disperses high-stress areas throughout the bag. Furthermore, a beneficial result accompanying this non-stationary deformation pattern of the bag lies in the increased vortex washing effect within the blood bag. The bag surface will be washed more thoroughly with random vortex formation and passage.The probability of producing a constant low-velocity recirculation zone in the region near the wall or fold lines will therefore be greatly reduced, resulting in a thrombus-resistant and long-lasting blood pump design.

[138] Figures 22, 23A and 23B show an exemplary embodiment of how an integration method is adopted to mount the blood bag assembly in the pump housing 62h, as well as to join a transmission line 67 to the proximal housing 623. The distal transmission line 67 has its first end connected to the blood pump 62 in passage 63 and the second end fabricated as a solid connector 678 that has electrodes 6781 mounted and covered by a curvature relief 679.

[139] The blood bag 629 is anchored in the pump housing 62h, which includes a proximal housing 623 and a distal housing 625, to facilitate the pump's loading and ejection actions. In general, the bending properties of the bag 629 and the housing 62h are very different. To realize a long-lasting bag design, it is necessary to install an intermediate suspension to make the pump assembly continuous in the transition of structural properties, in particular the bending deformation of the membrane. A pair of flexible rods 630 and 640 is adopted as a suspension that integrates the blood bag 629 to the housing 62h. As shown in Figure 23A, the rod Petition 870260041021, dated 04 / 05 / 2026, page 53 / 142 39 / 62 proximal 630, configured in a disc shape, connects to the proximal housing 623; while the distal rod 640, in the shape of a ring, connects to the distal housing 625. Mechanically, the proximal and distal rods 630, 640 function as a stress-relieving suspension, which not only keeps the blood bag within the pump housing 62h, but also prevents stress concentration from occurring at the interface fixation, thus extending the service life of the bag 629.

[140] As shown in the lower part of Figure 23A, the distal sheath 625 includes an extension, termed the distal sheath adapter 6251, which is to be coupled to the aortic adapter 14. This distal sheath adapter 6251 has a first end 6252 attached to the pouch 629 and a second end 6253 presented as a nozzle to be coupled to the interface adapter 501 (represented in Figures 18A and 18B). The first end 6252 of the adapter 6251 smoothly matches the distal end of the pouch 629. The opposite second end 6253, however, is configured to be paired with the interface adapter 501, and the purpose of the coupling design is to minimize interface discontinuity to avoid clot formation. The adapter 6251 has a flange structure 6254 that is disposed in the intermediate region of the distal housing adapter 6251, functioning as a locking element to be received by the interface adapter 501.

[141] During surgical operation, the closed-end bag design of the valveless blood pump 62 would attract air and cause air bubbles to accumulate at the top of the bag due to buoyancy force. As shown in Figures 22 and 24, a vent port 66 is therefore installed or produced in the proximal housing 623, in which a narrow channel 661 is provided above the stem 630. An integrated bag and stem septum 6301 as an extension of the channel 661 are used to allow the air removal needle to pierce and enter the blood chamber for air removal. In some embodiments, the channel 661 extends along the midline 62C. After the blood pump 62 is Petition 870260041021, dated 04 / 05 / 2026, page 54 / 142 40 / 62 anastomosed with the target artery 60, the trapped air will be pushed out by arterial blood pressure and emerge and accumulate over the dome space of the bag 629. A fine needle is used to pass through the de-air port 66, through the channel 661, penetrating the bag and the stem septum 6301, and finally reaches the interior of the blood bag 629 to discharge the accumulated air. The integrated bag and stem septum 6301 below the de-air port 66 is relatively rigid and not flexible, which will keep the punctured bag 629 from further structural failure due to the propagation of fissures initiated in the punctured slit when subjected to cyclic pulse pressure and stretching and bending of the neighboring bag.

[142] As illustrated in Figures 23A and 25A, the pressure sensing mechanism 627 is embedded in the proximal housing 623. Figure 23A illustrates the cutaway details of an integrated proximal housing 623, passage 63 and transmission line 67. Figure 25A represents the profile of the proximal housing 623 connecting a passage 63 extending from the dome of the housing 623 for pneumatic and signal communication with the transmission line 67.

[143] The pressure sensing mechanism 627, as detailed in Figures 25A and 25B, has a pressure sensor 6271, which is hermetically housed in a metal container, including a first space 6272 for fluid communication and a second space 6273 to accommodate the microelectromechanical system (MEMS) pressure transducer and associated electronic circuitry. Multiple electrodes 6274 protrude from the base of the second space 6273, to be connected to the electrical wires 6702 of the transmission line 67 (Figure 26). The second space 6273 is closer to the transmission line 67 than the first space 6272. The small tube of the first space 6272 is open for fluid communication with the sensing medium. Biocompatible fluid or gel is used as the pressure transmission medium. A pressure sensing cavity or chamber 628, located in the proximal housing 623 and adjacent to the first space 6272, is created to allow the sensing fluid to be confined.This 628 pressure detection chamber has... Petition 870260041021, dated 04 / 05 / 2026, page 55 / 142 41 / 62 a distal end separated from the blood chamber by the bag membrane 629. The pressure sensing chamber has two lateral arms: first arm 6281 and second arm 6282, wherein arm 6281 is used for installation of the pressure sensor 6271 and arm 6282 is used to carry and seal a sensing medium. The blood pressure pulse can therefore be transmitted through the bag membrane 629 and hydraulically communicated with the MEMS sensor 6271 located remotely in the second space 6273.

[144] One embodiment of the present invention innovates a method of blood pump control based on pressure and a sensor design. A miniature MEMS pressure sensor is adopted with packaged electronic circuitry embedded in the wall of the pump housing. In principle, the MEMS sensor array is very durable due to its intrinsic microscale structure. The durability of the sensor, in fact, depends on the packaging design. The present pressure sensing system 627 does not come into contact with blood and is isolated from the corrosive biochemical effects associated with blood, thus providing long-duration signal acquisition and transmission that is required for long-term implantable assistive devices.

[145] The transmission line 67 functions as a communicator for electrical signal transduction and pneumatic pulse pressure transfer between the blood pump 62 and the actuator 98. A representative multilayer transmission line 67 in the present invention is shown in Figure 26. In this embodiment, the transmission line 67 has a pneumatic lumen (or inner pneumatic tubing) 6701, a plurality of electrical wires 6702, an intermediate pneumatic tubing 673, a coil 674 (such as a metal coil), an outer layer tubing 675, a tie 676, a silicone sheath 677, a rigid drive connector 678 and a protective bend relief 679.

[146] The central portion of the transmission line 67 accommodates the pneumatic lumen 6701 (or air passage, internal tubing) with a lumen diameter of around 2 to 5 mm, depending on the preference for lower consumption. Petition 870260041021, dated 04 / 05 / 2026, page 56 / 142 42 / 62 power or low profile for ease of surgery. The electrical wires 6702 for signal transmission are embedded in the wall of the transmission line 67. There are transmission design variants that can be adopted. In addition to the multilayer transmission design shown in Figure 26, the transmission line 67, for example, can also be multiluminal to facilitate the incorporation of electrical wires 6702 in several smaller lumens and allow pulsed air to flow in a larger lumen 6701, as shown in Figure 27. One of the smaller lumens can be installed with the tie 676 so as to limit the stretching of the transmission line 67 and protect the electrical wires from damage when subjected to externalizing tensile force.

[147] The inner tubing, or pneumatic lumen 6701, is received by the intermediate tubing 673 with reinforcement placed between them. Between the inner and intermediate tubing 6701 and 673, the coil 674 (or woven or mesh yarn) may be reflow-molded (thermally co-molded using heat shrinking) as reinforcement for the transmission line wall, making the transmission line 67 flexible but resistant to twisting. The outer layer tubing 675 covers the inner and intermediate pneumatic tubing 6701 and 673 and may be used to cover the spirally wound electrical wires 6702 as a protective sheath. In some embodiments, a non-stretchable chain 676 may be disposed between the outer tubing 675 and the silicone sheath 677 of the transmission line 67, to strengthen the tensile resilience required during the externalization of the transmission line 67.Clinically, the 677 silicone sheath has been shown to be less irritating to subcutaneous tissues and has the lowest infection rate in the transmission line.

[148] In this embodiment, the pneumatic lumen 6701, the metal coil 674, the intermediate tubing 673, the spiral electrical wires 6702, the outer tubing 675, the tie 676 and the silicone sheath 677 are packed into a transmission line body 67. The proximal end 671 of the transmission line 67 must be connected to a receptacle housed in the actuator 98. The rigid transmission line connector 678 of the transmission line 67 is Petition 870260041021, dated 04 / 05 / 2026, page 57 / 142 43 / 62 configured to be received by the receptacle of the proximal transmission line interconnector 93 or by the actuator 98. The rigid drive connector 678 is mounted flush with a plurality of electrodes 6781 (e.g., four electrodes 6781 in Figure 23B) soldered with the electrical wires 6702. A protective bend relief 679 (see Figures 23B and 26) is placed over the transmission line joint segment 67 and the drive connector 678 in order to prevent the transmission line 67 from bending at the joint. The proximal end of the transmission line, including the drive connector 678 and the bend relief 679, is kept in low profile so that it is easy to exit the skin without creating undesirable tunneling trauma.

[149] The connection of the transmission line 67 to the blood pump 62 is made through a passage 63, as illustrated in Figures 22 and 23A. The passage 63 can be placed in the proximal housing 623 or in the distal housing 625, depending on the anatomy where the blood pump 62 will be implanted. The integration of the passage 63 with the pump housing 62h can alter the overall configuration of the external blood pump and direct the transmission line 67 in a specific direction to meet the implant requirements, including transmission line externalization route, postoperative skin care, and device usability.

[150] As shown in Figures 23A and 25A, passage 63 has a first portion 631 as an extension of the proximal housing 623 in which the pneumatic lumen 6701, the tether 676 and the electrical wires 6702 of the transmission line 67 are coupled through an anchoring adapter 672, wherein the anchoring adapter 672 connects to the distal transmission line 67 to allow air to pass through the pneumatic lumen 6701. Passage 63 additionally has a second portion 632 that is interconnected with the first portion 631 functioning as a bend relief for the transmission line 67. The first portion 631 is where the electrical wire connection, cable anchoring and pneumatic bonding and sealing of the lumen with the housing occur. It is necessary that the electrical wires are not exposed to the tissue of Petition 870260041021, dated 04 / 05 / 2026, p. 58 / 142 44 / 62 implant location and be well protected against the tensile force exerted during externalization of the transmission line. Furthermore, the connection of the pneumatic lumen 6701 to the blood pump 62 needs to be free of pneumatic and electrical leaks. As shown in Figure 25A, these aforementioned blood pump integration tasks are performed in the first portion 631. The second portion 632, however, is employed to accommodate and seal these interface joint elements, functioning as an external protector that shields the joint against mechanical stress and intrusion of environmental fluids or moisture.

[151] The modular design belonging to the first embodiment of the present blood pump invention is revealed in Figures 19 to 27. In this illustrated embodiment, the blood pump 62 includes an axially symmetric oval-shaped blood bag and stem assembly 650 (including a flexible membrane bag 629, a proximal stem 630 and a distal stem 640); a pump housing 62h having a proximal casing 623 and a distal casing 625; and a pressure sensing system 627 embedded in the proximal casing 623. A transmission line 67 is connected to the blood pump 62, including a pneumatic lumen 6701 and electrical wires 6702 embedded in its wall. To integrate the transmission line 67 with the pump housing 62h, a passage 63 is used to achieve electrical and pneumatic communication between the transmission line 67 and the blood pump 62.

[152] As shown in Figures 19 and 20, the manufacturing and polymer bonding method integrating the blood bag 629 and the rods 630, 640 was revealed in the previous section. The design and manufacturing fundamentals lie in maintaining high-precision axial symmetry in the manufacturing of parts and in the bonding of the bag and rod assembly. The pressure sensing system 627 and the passage 63 are installed in the rigid part of the proximal housing 623. As shown in Figures 22, 23A and 25A, a compact passage design 63 is illustrated. It can be observed that, through the compact passage 63, the electrical wiring and connection can be achieved in a more robust and Petition 870260041021, dated 04 / 05 / 2026, page 59 / 142 45 / 62 fault tolerant.

[153] Figures 28A and 28B depict some flow patterns associated with para-aortic counterpulsation. During the late diastolic and early systolic phases of left ventricular ejection, the blood pump is charged and draws aortic flow into the pump (Figure 28A). Upstream and downstream blood around the connector will be drawn into the blood pump, making a sharp 90-degree flow curve. Zones of flow separation and low-velocity T-201 recirculation will be created. In addition, an extraordinarily high shear will appear in the corner region of the T-junction. On the other hand, during the diastolic phase after aortic valve closure, the blood stored in the pump will be ejected back into the circulation, creating incident flow on the opposite aortic wall (Figure 28B).This lateral impact flow involves a very high local pressure at the T-202 impact point, the so-called stagnation point where the flow velocity is literally zero and all the kinetic energy associated with the flow velocity is converted into a potential energy called total pressure. This high-pressure impact flow can induce vascular maladaptation, including smooth muscle cell proliferation and resulting wall stenosis, and risk of aortic dissection due to persistent local hypertension. All these non-physiological flow patterns and the induced phenomena of high-pressure, high-shear, and low-velocity recirculation prevail in the vicinity of the T-junction region. This turbulent and complex flow anomaly will decay or diminish over a distance of 3 to 5 times the diameter of the implanted arterial lumen.The present insertion-type aortic adapter was designed to have an inserted conduit length of 5-7 cm, which covers most of the non-physiological flow region induced by the pump. Since the aorta at the implant site is protected by the inserted aortic adapter, the biological vascular wall will be isolated from the influences of pathological stress conditions induced by the pump, thus protecting the implant site artery against remodeling complications induced in the acute or long-term period. Petition 870260041021, dated 04 / 05 / 2026, page 60 / 142 46 / 62

[154] In counterpulsatile support, the pump loading and ejection are triggered alternately in synchronization with the heart rhythm, which generates a special flow at the T-junction, as shown in Figures 28A and 28B. This insertion-type aortic adapter 14 is further detailed in Figure 29, a perspective view, and in Figure 30, a cross-sectional view, respectively.

[155] The aortic adapter 14 is injection molded with its inner blood contact surface 141 being manufactured ultra-smooth and continuous without any dividing lines. Silicone or other polymeric elastomers may be used as material. The aortic adapter 14 comprises a conduit (or an inserted conduit portion) 142 that is to be inserted into the aorta 95 (see Figure 5) and a neck (or an extruded neck portion) 143 that connects to the blood pump.In this embodiment, the neck portion 143 has a neck body 1431 and an extension portion 1432 disposed within the neck body 1431, wherein the extension portion 1432 projects from the neck body 1431 and the maximum internal diameter of the extension portion 1432 is greater than the maximum internal diameter of the neck body 1431. When the neck portion 142 is connected to the blood pump 62, the extension portion 1432 snugly embraces the inlet adapter 6251 of the blood pump 62, and the neck body 1431 is disposed around the coupler 25 that integrates the aortic adapter 6251 to the blood pump 62.

[156] The entire aortic adapter 14 has thin walls to maximize flow efficiency. To strengthen the thin-walled structure, a pair of Nitinol trusses (or truss rings) 144 is embedded around the two ends of the conduit portion 142 of the aortic adapter 14.

[157] Truss 144 is manufactured from Nitinol, a material widely known in the state of the art, corresponding to a family of nickel-titanium alloys based on the intermetallic compound NiTi. The term Nitinol refers to alloys whose typical composition is in the approximate range of 53 to 57% nickel by weight, the remainder being titanium. The mechanical, physical and chemical properties of Nitinol depend on the chemical composition and processing history, Petition 870260041021, dated 04 / 05 / 2026, page 61 / 142 47 / 62, these characteristics being reproducible through adequate control of the nominal alloy composition and the general processing and heat treatment conditions (CM Jackson; HJ Wagner; RJ Wasilewski. “55-Nitinol — The Alloy with a Memory: Its Physical Metallurgy, Properties and Applications”. NASA Special Publication NASA-SP 5110, National Aeronautics and Space Administration, 1972).

[158] Figure 29 is a transparent view showing the locations where the Nitinol lattice 144 is embedded. Furthermore, the wall thickness of conduit 142 gradually decreases towards the end of conduit 145. The function of the gradual thinning of the wall thickness is twofold. First, it minimizes the discontinuity of the graft / host junction and causes the rate of clot formation at the interface to always be lower than the rate of thrombolysis provided by the contacted endothelium. Second, the conformity of the conduit becomes smoother towards the ends of conduit 145, resulting in a conformity matching effect when joined to the aortic lumen.

[159] One of the complications affecting the implantation of large endoprostheses is the problem of internal leakage. Type I endoleakage means that the seal of the graft end to the endothelial lumen of the implanted artery is not complete, creating a space between the leading edge of the graft and the arterial lumen. Leaked blood will become trapped and stuck in the spaces and solidify into a clot and eventually become fibrous pseudo-intimal tissue that will grow uncontrollably over time. Not only will the pseudo-intimal tissue obstruct the grafted artery, but it can also signal and stimulate the coagulation mechanism to attract platelet adhesion and lead to the occurrence of thrombotic adverse events. The solution to resolve this endoleakage problem is to have a hermetic seal of the aortic adapter 14 in relation to the surface of the fixed lumen.The present aortic adapter 14 features a conformal matching design concept that allows the semi-rigid conduit ends 145 to fit perfectly into the arterial lumen when subjected to it. Petition 870260041021, dated 04 / 05 / 2026, page 62 / 142 48 / 62 to pulsatile blood pressurization. The outer diameter 146 of the aortic adapter conduit 142 is slightly larger than the luminal diameter with an oversize ratio (defined as the percentage increase in the conduit diameter 146 relative to the luminal diameter) in the range of 3-10% conditioned to a certain nominal blood pressure (i.e., 120 mmHg). As blood pressure fluctuates between systole and diastole, or under the pulse pressure generated by counterpulsatile support, the ends of the conforming matching conduit 145 will dynamically expand and contract in response to the pressure pulsation without creating interfacial spaces.

[160] In general, a thin-walled tube made from elastomer is flexible and tends to be compliant, but is often not strong enough to withstand the compressive force exerted due to oversizing of the device, resulting in warping of the inserted adapter wall and enormous resulting bleeding. Therefore, the combined use of the Nitinol 144 truss structure and the elastomeric substrate with appropriate hardness is important. As shown in Figure 30, in this design, the radial stiffness provided by the Nitinol 144 truss will help support the aortic adapter 14 without deformation, and there is a predetermined distance (based on experience) provided between the outer limit 1441 of the truss 144 and the end of the conduit 145. This spacing ensures unobstructed fluid communication and avoids mechanical interference during cyclic deformation under pulsatile pressurization.In some modalities, this predetermined distance (based on experience) must be evaluated and correctly defined. With the support of the Nitinol 144 truss as a distensible structure, the gradually thinner end of the conduit 145 will not collapse or wrinkle, remaining in a circular shape against the fixed lumen wall and dynamically sealing with the lumen. Note that the aortic adapter 14 can expand and contract in response to pressure pulsation, and the sealing effect is achieved dynamically, so that the aortic adapter 14 and the aortic wall 95 expand and contract together as a whole to seal the conduit end 145 without causing... Petition 870260041021, dated 04 / 05 / 2026, page 63 / 142 49 / 62 hemorrhagic complications.

[161] Figure 31 illustrates a representative embodiment of the Nitinol 144 truss which is typically manufactured from a laser-cut Nitinol tube and further enlarged under an expansion sequence and heat treatment. Figure 31 shows the two-dimensional expanded view of the truss ring 144. Each truss has a plurality of corrugated structures 1441. The truss 144 is self-expanding, which can be bent or crimped into a smaller pre-packaged delivery configuration and expands to resume its original configuration when released after being placed in the desired location.

[162] A convenient measure of conduit stiffness (inverse of conformance) can be represented by the so-called lateral stiffness (LS), the measurement method of which is illustrated in Figure 32. LS is defined by the applied force per unit length F divided by the corresponding radial deflection Y. For the present aortic adapter, the appropriate LS range is 0.01-0.05 Nt / mm2. Both the embedded Nitinol lattice 144 and the silicone or elastomer substrate will contribute to the structural conformance of the co-injected aortic adapter 14. It is best to have an evenly distributed flexibility so that stretching and contraction of the composite conduit wall result in a minimal tendency for interlayer delamination to increase the fatigue life of the adapter 14.

[163] The aortic adapter 14 is configured to be connected to the blood pump 62 to facilitate circulatory support. A quick-connect type coupler is invented in the present document. Figure 33 illustrates an exploded view of the components of the coupler 25 integrating the aortic adapter 14 and the blood pump 62. The present coupler 25 includes a flange base 252, a pair of collars 253, and hinges (or a hinge assembly) 254 that join the collars 253 to the flange base 252. The coil springs (or a coil spring assembly) 255 are loaded into a hinge joint 256, keeping the collars 253 in an open position when unlocked (Figure 34A). The locking mechanism is a latch 257, made of leaf spring. Petition 870260041021, dated 04 / 05 / 2026, page 64 / 142 50 / 62 grooved and fixed by a plate 2571 welded to one end of the collars 253. The flange base 252 has a substantially circular structure and each collar 253 has an arc-shaped structure. The hinge joint 256 is located on the first side 252S1 of the flange base 252 and the collars 253 are articulated to the hinge joint 256 and rotatable to the hinge joint 256 and to the flange base 252. In some embodiments, the coupler 25 and the aortic adapter 14 belong to portions of an aortic adapter assembly.

[164] Figure 34B shows the image of the coupler 25 in a locked configuration, in which a leaf spring latch 257 is lowered from a ramp 258 to ensure that the coupling is secure without concern for detachment. The collars 253 are internally grooved as shown in Figure 35. The integration of the aortic adapter 14 to the blood pump 62 is achieved through a fastening mechanism using the proximal end of the deformable adapter 147 (Figure 30) serving as a “joint” between the connected rigid flanges 252 and 81 of the coupler 25 (see Figure 35) and the blood pump inlet adapter 6251, respectively.

[165] In particular, quick-connect type locking can be easily achieved by closing the collars 253 which will be locked without concern for unintentional unlocking, as shown in Figures 34B and 35. The leaf spring latch 257 is installed at the end of a collar 253. During collar closure, this latch 257 will be folded as it slides on a ramp 258 on the opposite collar 253 during the locking process. As the latch 257 exits the top of the ramp 258, it will descend to the base of the ramp 258 by the elastic restoring force, functioning as a safe to prevent accidental unlocking of the latch or opening of the collar attributed to pump vibration or swinging during long-term use. For an explant or pump replacement that requires uncoupling the module, latch 257 can be bent and lifted upwards by a tool, allowing an unlocking force to be applied to rotatably open collars 253 and, Petition 870260041021, dated 04 / 05 / 2026, p. 65 / 142 51 / 62 therefore, disconnect the blood pump 62 from the aortic adapter 14.

[166] A butt joint design is not feasible for connecting two smooth-surface tube adapters in a bloodstream. In most clinical applications, the connected graft has a rough surface to promote endothelialization, so that the small interface discontinuity in the bloodstream is “smoothed” by embedded cells and proteins. The present aortic adapter 14 adopts a smooth-surface approach to avoid the occurrence of adverse thrombotic events. Blood flow in the aortic adapter is bidirectional in response to the ejection and loading action of counterpulsatile pumping, as depicted in Figures 28A and 28B. This strong bidirectional flow and surface washout effect will easily dislodge any newly formed blood clot on the rough surface. Thus, the smooth-surface design is considered more suitable and safer for the present invention.The interface of two smooth surfaces joined in the bloodstream requires careful mechanical and hemodynamic design to prevent thrombotic events from occurring in situ. The logic and design method associated with this new joint invention are revealed below.

[167] Figures 36A and 36B respectively show the two fundamental interface discontinuities that exist in a butt joint connection, such as steps 101, 102 or the space 103 produced between an adapter AB1 (such as a blood pump adapter 62) and an adapter AB2 (such as the aortic adapter 14). The discontinuities shown in Figures 36A and 36B are exaggerated and normally in precision machinery such joint discontinuities are within 10-50 microns, which is large enough to cause the formation of clots and thrombi.

[168] In practice, tolerance inevitably exists in the joining of two separate bodies, even if the machining of each body is performed perfectly. Figure 36A represents a misaligned joint of two bodies, in which everything related to the manufacture of the parts is produced correctly, except for the misalignment of the centerline. The forward and backward facing steps Petition 870260041021, dated 04 / 05 / 2026, page 66 / 142 52 / 62 101, 102 will be produced and the stagnation flow in the step regions 101, 102 is the origin of the clot or thromboembolism that will be generated. In Figure 36B, an interface space 103 is created due to the non-parallel correspondence of the connected bodies. The space 103 attracts blood cells so that they accumulate and grow further into pseudo-intima and this intimal growth is often uncontrollable, resulting in the blockage of the entire passage of blood flow, in addition to thromboemboli released from the intimal surface. Interface errors associated with the butt joint can be exacerbated when the connected bodies are not rigid. The present aortic adapter 14 is semi-rigid, which can be forced into a butt joint connection with a deformed configuration and enlarged interface discontinuities. Therefore, to achieve the present connection of the semi-rigid aortic adapter with the blood pump, a new connection method must be invented, as disclosed below.

[169] As shown in Figures 37 and 38, in some embodiments, the blood pump 62 has an inlet adapter 80, comprising a flange 81, a nozzle 82 and a base 83, forming an extension of the blood pump housing 62. Several eyelets 86 are fitted to join the inlet adapter 80 to the blood pump 62.

[170] The inner diameter 84 of the nozzle 82 is slightly larger than the inner diameter 148 (see Figure 30) of the neck 143 of the aortic adapter 14. The contact area between the nozzle 82 and the proximal end of the adapter 147 is an annular conical surface (or a shallow inclined surface or ramp) 149 (Figures 30 and 35). The angle of the cone of the surface 149 is substantially in the range of 30 to 60 degrees measured from the centerline of revolution of the inlet adapter 80. In the initial locking engagement, the collars 253, which have internal grooves 2531 (Figure 34A), will loosely hold the base flange 252 and the nozzle flange 81. Along with the closing of the collars 253, the flanges 81, 252 (of the nozzle 82 and the coupler 25) will be received and squeezed by the collar grooves 2531, thus compressing the crimped silicone end 147 and generating the clamping force necessary for a firm connection. Petition 870260041021, dated 04 / 05 / 2026, page 67 / 142 53 / 62

[171] The fixation force generation mechanism is shown graphically in Figure 35. There are two steps 2521 and 2522 that are responsible for creating fixation forces. Before the collar closure begins, step 2521 must be engaged in slot 1433 of the aortic neck adapter 143 (Figure 30). This engagement is achieved by first bending the neck 143 and then inserting the deformed neck 143 through the flange of the adapter 252, allowing the elastic restoring force of the aortic adapter 14 to return the bent neck 143 to its original circular shape and allowing the step 2521 to be fitted into the groove 1433. The height of the Z groove of the collar 143 controls the compressive deformation of the end of the aortic adapter 147. Referring to Figure 35, it can be seen that the relief Z0, in the fully locked configuration when the collars 253 are closed and locked, is less than the final width of the aortic adapter Z3 (Figure 30).Speculation of the assembled geometry shows that Z0=ZZ1-Z2, where Z1 and Z2 are the flange thicknesses of the fixed counterparts as shown in Figure 35. In general, Z3 is greater than Z0, therefore, the tensioned aortic adapter end 147 will generate the clamping force required for a sealed connection of the nozzle flange 81 together with the collar flange base 252. The tension of the silicone flow adapter end 147, defined as (Z3-Z0) / Z3, in the range of 10-30%, is sufficient to ensure a reliable sealed connection.

[172] Figure 39 illustrates the joint characteristic of the present connection of the nozzle 82 with the surface of the adapter cone 149. When connected, the leading edge of the nozzle 85 and the cone surface 82 will sink into the semi-rigid ramp surface 149 of the aortic adapter 14 with a depth comparable to the leading edge radius, typically 30-50 microns, of the leading edge of nozzle 85. In Figure 39, the dashed line and the number in parentheses represent the nozzle in initial contact, while the solid line and the numbers without parentheses represent the locked relationship. Note that the interface discontinuity is reduced by the depression of the cone surface relative to its original shape (the dashed line). The width of the collar groove 2531 controls the Petition 870260041021, dated 04 / 05 / 2026, page 68 / 142 54 / 62 interference fit of the coupling. As explained previously, the elastic end of the aortic adapter 147 will be compressed with approximately 10-30% tension to provide the coupling force necessary for leak-free integration against pulsatile pumping.

[173] The present interface linkage design between the blood pump 62 and the aortic adapter 14 has two hemodynamic merits for reducing in situ thrombus formation. First, there will be literally no step-type joint discontinuity or relief generated as observed in conventional butt joint linkage. Second, the localized stasis flow at the leading edge interface of the nozzle 85 can be minimized. Consequently, the blood flow through the connected interface will be maintained at high speed, substantially improving the disadvantage of butt connection, i.e., the forward or backward facing steps 101,102 or the space 103 created at the interface.

[174] The present conical surface 149 is inclined at an angle of inclination relative to the direction of the current. This ramp interface design avoids the generation of a step or gap in the joint due to limited manufacturing precision or the corresponding eccentricity associated with conventional butt connections. However, this shallow cone-shaped ramp 149 has an intrinsic deficiency in achieving concentric alignment of the centerline of the joined counterparts. The present coupling of the aortic adapter 14 with the inlet nozzle 82 does not have strict lateral restraint to ensure coupling alignment. To connect a rigid nozzle 82 with a semi-rigid aortic adapter flange ramp 149 concentrically, simultaneous engagement of the collars around the entire peripheral rim of the flange base 252 is critical.When a simultaneous locking / locking engagement fails to be performed, the initially locked adapter flange ramp 149 will be under more tension than another free portion, creating a tendency to tilt or dispose of the resting contact surface, leading to a pump connection. Petition 870260041021, dated 04 / 05 / 2026, page 69 / 142 55 / 62 eccentric. This eccentric connection is usually the causal factor that generates a step or gap at the interface that induces thrombus formation. This disadvantage is remedied by having the contour of the flange 259 (Figure 34A) of the distal flange of the collars 253 configured so that the locking engagement simultaneously includes all circumferential contact areas. When locked, the contacted edge of the metal tip 82 will sink slightly into the compressed silicone ramp 149 with controlled depth and further reduces the interface discontinuity when exposed to the bloodstream. Thus, conventional interface thrombus can be substantially minimized or eliminated with moderate administration of an anticoagulant regimen.

[175] The structural deformability and delivery method involved in the present aortic adapter confer a special design characteristic to the present invention. The consideration of the material's elasticity, in fact, needs to be carefully incorporated into the current design. Surgical delivery of an insertion-type graft into the aorta through the incised aortic wall is a challenge in terms of perioperative safety and long-term reliability. The material chosen for the present aortic adapter 14 should have a pre-memorized shape. During the delivery of the device, the adapter 14 is first compressed into a smaller delivery configuration, and this delivery configuration ensures rapid and safe implantation of the device. After the corrugated aortic adapter 14 is placed in the intended implantation site, the delivery configuration should be released to self-expand to its original memorized shape.

[176] Before inserting the aortic adapter, a 12-14 mm diameter hole must be made in the aortic wall. When making this access hole, care must be taken to avoid making sharp edges that could become a point of initiation for fissures when distension of the wall is necessary for device insertion. A lateral bite aortic puncture, as disclosed in US Patent Application No. 17 / 034036, is an ideal tool for making a large hole in the aorta. With a single perforation, a clean hole is created without Petition 870260041021, dated 04 / 05 / 2026, page 70 / 142 56 / 62 irregularities on the edges can be successfully addressed.

[177] The aortic adapter 14 morphologically includes two circular tubes joined in a T-shaped flow communicator for application of para-aortic circulatory support. The conduit wall is typically 1-2 mm thick and the material used is a polymer such as silicone or polyurethane with appropriate hardness, for example, Shore A 80-90. The corrugated delivery configuration differs substantially from the large commercially available endoprosthesis covered by Dacron or PTFE (polytetrafluoroethylene) fabric. Figure 40 illustrates the corrugated form of the aortic adapter 14 (the Nitinol-based lattice 144 is embedded and deformed with the polymeric substrate). The aortic adapter 14 is folded by crushing the inserted conduit portion 142 and the T-neck (extruded neck portion) 143 is compressed and flattened accordingly and sunken into the folded adapter 14 as shown in Figure 40.The folded configuration has a diameter that is approximately half the diameter of the original unfolded circle.

[178] This folded adapter can be held in place by tightening the wire. For example, as shown in Figure 40, three fixation wires can be placed around the two edges and the center of the conduit, and many other fixation methods can be devised. Figures 41A, 41B, 41C, and 41D show the four representative stages of an aortic adapter delivery 14. The first stage (see Figure 41A) represents the initial penetration of the crimped prepackage through the access orifice while the prepackage is angled relative to the aortic axis 95. The second stage (Figure 41B) illustrates the complete insertion of the delivery configuration into the aorta, where the prepackage is pushed through the access orifice with the proximal end being rotated and simply dropped into the access orifice. The fully inserted prepackage is then retracted to have its crimped neck 143 aligned with the drilled access orifice (Figure 41C).The wire constraints will be released and the pre-packaged delivery configuration will return to its original deployed configuration by elastic self-expansion (Figure 41D). O. Petition 870260041021, dated 04 / 05 / 2026, page 71 / 142 The released 57 / 62 aortic adapter 14 will be firmly embraced by the aortic lumen, ensured by an appropriate oversizing ratio selected before delivery. By slightly deforming the neck at T 143, the flange 252 of the coupler 25 (Figures 33 to 34B) can be mounted on the neck at T 143 ready for the blood pump 62 to be connected. The blood pump connection can therefore be easily performed by seating the inlet nozzle 82 on the conical surface of the neck at T 149, followed by closing the two collars 253 of the coupler 25 for a firm device integration.

[179] Additional safety measures can be applied to improve hemostasis and stability of the implanted para-aortic blood pump system.Para-aortic placement of the blood pump inevitably involves lateral force (perpendicular to the longitudinal direction of the aorta) and torque exerted on the aortic adapter 14 due to the weight of the blood pump 62 and the pumping forces generated by the counterpulsatile support. Such external force related to the device may affect the long-term remodeling of the vascular structure at the implantation site. A purse-string suture can be placed in the adventitial layer around the access orifice. The purse-string suture can additionally tighten the aortic wall against the inserted adapter 14 and acts as a protective measure to prevent widening of the access orifice. Furthermore, surgical tapes can be wrapped and tightened around both ends of the conduit 142, reinforcing the integration of the inserted aortic adapter 14 and the aorta as a whole.The absence of internal leakage can be doubly guaranteed by the conformity-compliant design and the loop straps. Sometimes, blood pressure can rise beyond the upper limit that can be ensured by conformity matching. Under these extreme conditions, surgical tapes come into play, acting as a rigid limiter that seals the ends of the disconnected adapter and ensures the maintenance of hemostasis.

[180] The step-by-step demonstration of the aortic adapter 14 implant is Petition 870260041021, dated 04 / 05 / 2026, page 72 / 142 58 / 62 detailed in Figure 42. A pre-packaged, crimped form is prepared before implantation begins. After left thoracotomy to expose the target thoracic artery, a cross-clamping distance of approximately 10 cm encompassing the implant site is defined. The access hole to be drilled in the aorta is first marked with the periphery of the hole identified. A purse-string suture is then stitched outside the periphery of the hole in the adventitial layer. The aorta may be partially dissected from the surrounding connective tissue, and a pair of surgical tapes may be wrapped around the aorta. Cross-clamping and insertion of the aortic adapter are performed after completion of the above preparation work. These insertion steps are described in a sequential order illustrated in Figure 42. First, the aorta is cross-clamped to provide an isolated segment without concern for bleeding.A large access hole for insertion of the aortic adapter is then made using a custom aortic punch. The pre-packaged folded adapter is then inserted and placed in the aortic segment with cross-clamping, as illustrated in Figures 41A, B, and C, followed by release and restoration of the folded adapter to its original unfolded form (Figure 41D). The bag wire and straps are then tightened as extra protection against internal leakage in hypertension. The coupler is then installed with its adapter flange 2521 seated in the slot 1433 of the aortic adapter neck, ready to receive the blood pump 22 to be connected. The self-aligning capability of the coupler design allows the nozzle 80 of the blood pump 62 to be properly positioned and locked together with the aortic adapter 14.The remaining implantation steps are conventional, including releasing the cross-clamp, de-airing the blood pump, and initiating pump support. Generally, for a trained surgeon, the cross-clamping period required for aortic adapter insertion is approximately 10 minutes. During this cross-clamping period, abdominal organs will be deprived of blood perfusion, and ischemic injury may occur. To mitigate this potential surgical insult to the organs, support is provided. Petition 870260041021, dated 04 / 05 / 2026, page 73 / 142 Partial extracorporeal membrane oxygenation (ECMO) of 59 / 62 minutes may be administered to perfuse abdominal organs and the lower limb. However, the use of ECMO support is at the surgeon's discretion. Generally, an ischemic time of 20 minutes can be tolerated by a healthy patient.

[181] In summary, one embodiment of the present invention provides a ventricular assist device, including a blood pump, a transmission line and a passage. The blood pump includes an axially symmetrical oval-shaped blood bag and rod assembly, including a flexible membrane bag, a proximal rod and a distal rod, wherein the flexible membrane bag is attached to the proximal and distal rods as a stress-relieving suspension mechanism; a pump housing, including a proximal housing and a distal housing, wherein the stress-relieving suspension mechanism is coupled to the pump housing; and a pressure sensing system, embedded in the proximal housing, wherein the pressure sensing system includes a pressure sensor and a pressure sensing chamber that is charged with an incompressible fluid for pressure transmission.The transmission line includes a pneumatic lumen, at least one electrical wire, and a tie, in which the electrical wires and the tie are arranged on the transmission line wall. The passage connects the transmission line to the pump housing.

[182] One embodiment of the present displacement pump invention reveals a pulsatile blood pump design incorporating a non-stationary bending line concept in the construction of a long-lasting blood bag that can substantially extend the durability of a displacement-type blood pump. Furthermore, a miniature pressure sensing system is disclosed, which can be used to serve as a reference waveform for real-time pump control, as well as for long-term trend analysis, disease monitoring and diagnosis, based on evidence-based big data. In addition, the sensing system Petition 870260041021, dated 04 / 05 / 2026, p. 74 / 142 The 60 / 62 pressure sensor incorporated does not come into contact with the blood, which therefore greatly improves the reliability requirements in the construction of an implantable sensor system.

[183] ​​The embodiment of the present blood pump invention has at least one of the following advantages or effects. By connecting the transmission line to the pump housing via a pass-through, a compact pass-through design is provided to make the electrical wiring and signal transduction more robust and fault-tolerant. In addition, a compact pass-through design integrates the sensory electrical wires and pneumatic tubing into the blood pump. This compactness attribute is particularly essential for implantable devices. It not only simplifies the surgical operation and mitigates the risks of perioperative implantation, but also contributes to reducing postoperative morbidity associated with transmission line infection.

[184] In some blood pump designs, the passage is integrated into a distal housing of the pump housing and the passage has a first portion as an extension of the distal housing in which the pneumatic lumen, tether and electrical wire of the transmission line are coupled, and a second portion being interconnected with the first portion functioning as a curvature relief of the transmission line, with the advantage of anatomical adaptability and suitability to the geometry of the implant site.

[185] One embodiment of the present flow communication invention provides an aortic adapter assembly, for an implantable ventricular assist device, comprising: a T-shaped aortic adapter, which includes: an inserted conduit portion, an extruded neck portion, wherein the inserted conduit portion is joined to the extruded neck portion, wherein both have a smooth surface in contact with the blood; and a lattice, disposed in the inserted conduit portion; wherein the T-shaped aortic adapter has a polymer elastomer reinforced by the lattice which has a Nitinol-based material; wherein the inserted conduit portion has a wall that gradually tapers at two conduit ends of the inserted conduit portion, Petition 870260041021, dated 04 / 05 / 2026, p. 75 / 142 61 / 62 with an appropriate distance from one end of the conduit to the outer limit of the truss, and the conduit end has a conforming matching effect on an artery at the implant site; wherein a proximal end of the extruded neck portion is configured to be attached to an inlet adapter of a blood pump.

[186] The present invention's flow communication embodiment has at least one of the following advantages or effects. The present invention discloses a flow communicator assembly that allows the transport of blood flow into and out of a para-aortic ventricular assist device 10, in particular, a counterpulsatile blood pump. Unlike many existing flow communicators that employ a rough surface approach to promote endothelialization in order to avoid the occurrence of adverse thrombotic events, the present invention of the aortic adapter adopts a smooth surface insertion type prosthetic graft concept to construct the flow communicator.Furthermore, a conformity matching design is incorporated around the ends of the inserted conduit, which combines the gradually thinner wall characteristic with a superelastic Nitinol-supported thin-walled polymer to meet the endodontic leak-free requirement. Abnormal phenomena of high pressure, high shear, and low-velocity recirculation flow associated with para-aortic counterpulsatile pumping are contained within the artificial surface of the inserted conduit. Consequently, hemodynamic influences and pathological device-induced risk factors are substantially eliminated, and adverse events related to long-term vascular maladaptation, such as endothelial cell erosion, lipid infiltration, smooth muscle cell proliferation, vascular stenosis, arterial wall dissection, etc., are significantly reduced.To achieve a solid connection between the semi-rigid flow adapter and a blood pump, a quick-connect type coupler was invented. This coupler has a self-aligning interface design that minimizes discontinuity. Petition 870260041021, dated 04 / 05 / 2026, page 76 / 142 The 62 / 62 step and spacing design reduces the possibility of adverse thrombotic events at the interface joint. Accompanying this invention of the aortic adapter is a specially designed delivery method that ensures a fast and safe delivery procedure. The crimped aortic adapter is transformed into a pre-packaged delivery configuration whose overall size is reduced to half its implanted configuration. This pre-packaged adapter can be easily inserted into the aorta at the implantation site and self-expands to its original implanted configuration, resulting in a well-fitting flow communicator without the concern of internal leakage. This is not only beneficial for surgical operations by mitigating perioperative implantation risks, but also contributes to reducing postoperative morbidity associated with device-induced flow and poor vascular adaptation at the implantation site.

[187] The use of ordinal terms such as “first”, “second”, “third”, etc., in claims to modify a claim element does not, in itself, connote any priority, precedence or order of a claim element over another order or the temporal order in which the acts of a method are performed, but are used only as labels to distinguish a claim element with a given name from another element with the same name (but for use of the ordinal term) to distinguish the claim elements.

[188] Embodiments of this invention are described, and variations of these embodiments may become apparent to those skilled in the art after reading the foregoing description. Consequently, this invention includes all modifications and equivalents of the matter set forth in the claims. Petition 870260041021, dated 04 / 05 / 2026, p. 77 / 142

Claims

1 / 4 CLAIMS 1. AORTIC ADAPTER ASSEMBLY FOR APPLICATION IN A PARA-AORTIC BLOOD PUMP DEVICE, WHEREIN THE PARA-AORTIC BLOOD PUMP DEVICE CONTAINS A BLOOD PUMP AND A BLOOD PUMP ACTUATOR, characterized in that the aortic adapter assembly comprises: an aortic adapter (14) with a T-shaped flow connector, and the T-shaped flow connector comprising: an inserted conduit portion and an extruded neck portion (143); wherein the inserted conduit portion is joined to the extruded neck portion (143); wherein both have a smooth surface in contact with the blood (141); and a truss (144), disposed in the inserted conduit portion; a coupler (25), being connected between the extruded portion of the neck of the aortic adapter (14) and an inlet adapter of the blood pump (6251), causing the aortic adapter (14) and the inlet adapter to couple to each other;wherein the coupler (25) comprises a flange base (252) and a pair of collars (253) rotatably mounted on the flange base (252), and the collars (253) have internal grooves to receive and compress together the extruded neck portion (143) and a cone-shaped nozzle of the inlet adapter; wherein the T-shaped flow connector has a polymer elastomer reinforced by the truss (144) which has a Nitinol material; wherein the inserted conduit portion has a wall that is gradually tapering at two conduit ends of the inserted conduit portion, with a suitable distance from one end of the conduit end to the outer limit of the truss (144), and the conduit end has a conforming matching effect on an artery at the implant site;wherein a proximal end of the extruded neck portion (143) is configured to be joined to an inlet adapter of a blood pump (6251).

2. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the truss (144) is co-injected and embedded in the wall of the inserted conduit portion of the T-shaped flow connector.

3. AORTIC ADAPTER ASSEMBLY, according to claim 2, characterized in that the polymeric substrate is a silicone material.

4. AORTIC ADAPTER ASSEMBLY, according to claim 2, characterized in that the polymeric substrate is an injection-molded polyurethane.

5. AORTIC ADAPTER ASSEMBLY, according to claim 2, characterized in that a structural conformity of the truss (144) and a structural conformity of the polymeric substrate are substantially the same as each other.

6. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the gradually thinner conduit ends (145) have sharp edges.

7. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the extruded neck portion (143) has a shallow inclined surface to match a blood pump inlet adapter (6251), and an inner diameter of the extruded neck portion (143) is slightly smaller than an inner diameter of the blood pump inlet adapter (6251).

8. AORTIC ADAPTER ASSEMBLY, according to claim 7, characterized in that the shallow inclined surface is inclined relative to a direction of extension of the inserted duct portion.

9. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the truss (144) has a plurality of wavy structures.

10. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the extruded neck portion (143) includes: Petition 870260041021, dated 04 / 05 / 2026, page 9 / 142 3 / 4 a neck body (1431); and an extension piece (1432), disposed in the neck body, wherein the extension piece (1432) projects from the neck body (1431), and the maximum internal diameter of the extension piece (1432) is greater than the maximum internal diameter of the neck body (1431).

11. AORTIC ADAPTER ASSEMBLY, according to claim 10, characterized in that, when the extruded neck portion (143) is joined to the inlet adapter, the extension portion snugly embraces the inlet adapter, and the neck body (1431) is arranged around the inlet adapter.

12. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that each of the collars (253) has a flange contour (259) that allows simultaneous engagement of the collars (253) with respect to a flange base ring (252).

13. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the lock (257) is made from a leaf spring which ensures that the coupler (25) is locked without concern for accidental disengagement.

14. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the coupler (25) additionally includes a hinge joint (254) disposed at the base of the flange (252), and the collars (253) are articulatedly connected to the hinge joint (254) and rotatable relative to the hinge joint (254) and the flange base (252).

15. AORTIC ADAPTER ASSEMBLY, according to claim 14, characterized in that the hinge joint (254) is situated on the first side of the flange base (252), and the latch (257) is situated on a second side of the flange base (252), wherein the second side is opposite the first side.

16. AORTIC ADAPTER ASSEMBLY, according to claim 15, characterized in that the latch (257) has a slot that can be engaged in a ramp (258) on the opposite collar (253).

17. AORTIC ADAPTER ASSEMBLY, according to claim 1, characterized in that the flange base (252) has a substantially circular structure, and each collar (253) has an arc-shaped structure. Petition 870260041021, dated 04 / 05 / 2026, page 11 / 142

Images