Ventricular assist device with built-in pressure sensor

Abstract

A ventricular assist device with an integrated pressure sensor includes a blood pump, a carrier, and an introduction material. The blood pump includes a pump housing, an axisymmetric elliptical blood sac and stalk assembly housed in the pump housing, and a pressure sensing system fitted into the pump housing. The carrier includes an air lumen and at least one electric wire and tether contained in a wall of the carrier, the electric wire and tether being disposed in the air lumen. The introduction material connects the carrier and the pump housing.

Description

[Technical field]

[0001] The present invention relates to a ventricular assist device (VAD), and in particular to a left ventricular assist device (LVAD) based on the principle of counterpulsation support. [Background technology]

[0002] Pulsatile circulatory support is usually related to the transfer of blood volume to a limited space inside a blood pump. Energy transfer is related to the filling and discharging motion of the blood volume moving through the blood pump. Such energy converters that transfer externally generated kinetic energy to the blood flow to support human circulation are called volumetric pumps, and the excited blood flow is usually pulsatile. Historically, pulsatile blood pumps are divided into valved and valveless pumps. The former usually have separate inflow and outflow channels, each of which is equipped with an artificial heart valve, to realize unidirectional flow transmission in the blood pump.

[0003] To maximize the effect of pulsatile support, the blood pump used works better in synchronization with the heart rate. Most commonly, when matched with the artery, the blood pump pumps blood in a counterpulsatile manner. Pulsatile circulatory support has already proven to be effective and therapeutic in clinical practice, providing contractile stress to the myocardium during systole and enhancing coronary and organ perfusion during diastole. To date, most long-term implanted pulsatile pumps have been performed with electrocardiogram (ECG) waveforms as a reference signal to trigger pump jetting and hyperemia. For long-term circulatory support, a reliable ECG waveform is critical to command pump operation. Usually, electrical wires must be implanted and externalized together with the air delivery device. This increases the complexity and invasiveness of the surgery, and the pore size and stiffness of the delivery device increase accordingly. This results in a worsening of the mechanical failure or infection morbidity associated with power delivery and ECG induction.

[0004] The majority of end-stage heart failure patients (20-30%) have arrhythmias. In patients with arrhythmias, the irregularity of the ECG waveform makes it difficult to identify the correct timing to trigger counterpulsation pumping. Incorrectly performed counterpulsation support may damage rather than save the failing heart. Therefore, we limited antipulsation support to the use of only nonarrhythmic end-stage heart failure cues.

[0005] The role played by the blood pump pressure is twofold. First, it can be used as a reference for real-time pump control. Secondly, the recorded stress data can reflect the disease development after equipment intervention and can be used for the purpose of long-term health monitoring and trend analysis. For real-time pumping control, the instantaneously detected pressure waveform should be used as a reference to command the pump filling and popping motion in combination with a special sequential filtration program and control logic to promote reverse pulse circulatory support. Such a controller design has been constructed.

[0006] Blood pump Sensors The pressure sensed by the pump is a superimposed signal of the natural arterial pressure and the pressure delivered by the driver. When the pumping action stops, the pressure detected is approximately equal to the natural arterial pressure. For long-term health monitoring applications, the pump control device can be set to a constant tempo, without the need for equipment. For example, within a one-minute assisted time, one or two consecutive beats can be programmed without assistance to obtain the actual arterial pressure and record it as an ensemble. Thus, a set of 1440 pressure waveforms is collected per day, which is sufficient to trend arterial pressure behavior for long-term disease status monitoring and diagnosis.

[0007] Compared with rotary pumps, displacement blood pumps are considered to have poor durability. In failure mode, the rupture of the blood sac membrane often causes a support disaster. Circulation, alternating filling and discharging stroke motion favors discharging type pumping with respect to the blood volume stored in the sac cavity. The energy of the external pump is supplied by the driver through the power transmission member. Usually, the capsule filling stage is associated with low energy supply, and the ejection stage is associated with high energy supply, which drives the stored blood against the arterial pressure to the human circulation. The fatigue life of the sac depends on the maximum strain that appears in the folds of the folding film and the hanging area where the film is connected to the rigid case. In addition to the structural strength criteria in the sac design, the hemodynamic vortex washing effect of the sac is also important. The lower the residual volume in the pump discharge stage, the better the discharge of blood in the sac and the stronger the vortex formed in the next pump filling stage. However, the lower the residual volume, the more tension the sac deformation in the folds and suspension interface area will be. These contradictory design criteria usually force the designer to choose a trade-off design perspective that serves the hemodynamic consideration. This is one of the main reasons related to the durability problem of membrane type positive displacement blood pumps. Therefore, how to provide a durable and antithrombogenic blood pump for better use in ventricular assist devices is an important issue to support the safety and efficacy. Summary of the Invention

[0008] An embodiment of the present invention provides a ventricular assist device including a blood pump, a carrier, and an injector. The blood pump includes a pump housing and a pressure sensing system fitted into the pump housing. The carrier includes: air a lumen and at least one wire and tether contained in a wall of the carrier, the wire and tether being air The lead-in material is disposed in the lumen and connects the carrier material to the pump housing.

[0009] In one embodiment, the proximal housing includes an exhaust port.

[0010] In one embodiment, the passage is in communication with the exhaust port and the passage is an elliptical blood sac and a stalk that are axially symmetric. assemblyThe blood sac and stem extend along the centerline of the assembly It is located above the septum.

[0011] In one embodiment, the flexible blood sac has an inversion membrane located at a distal end of the flexible blood sac; and Distal stem is enclosed and attached by an inversion membrane, and the proximal stalk is located at the proximal end of the flexible blood sac.

[0012] In some embodiments, further Interface Adapter Arteries with connector Including, Distal Housing to facilitate the connection of blood pumps to human arteries. Distal Housing Adapter The housing has adapter has a first end and a second end, the first end being connected to the inlet of the flexible blood sac and the second end being Interface Adapter to be connected to a person's arteries.

[0013] In one embodiment, the Distal Housing Adapter It has a beak, and the beak is interface A flange structure is coupled to the adapter.

[0014] In one embodiment, the ventricular assist device further includes a drive section, the carrier connecting the blood pump to the drive section.

[0015] In one embodiment, the pressure Sensors is sealed in a metal can and pressurized Sensors includes a first space for fluid communication.

[0016] In one embodiment, the pressure Sensors The pressure sensor includes a second space closer to the carrier than the first space, the second space being a micro-electromechanical system (MEMS) pressure sensor. Sensors and arranged to house the electronic circuitry.

[0017] In one embodiment, the pressure sensing chamber comprises: Proximal End Housing Located within and adjacent to the first space, a pressure sensing chamber is adapted for trapping a sensing fluid therein.

[0018] In one embodiment, the pressure sensing chamber has a first arm and a second arm, the first arm being used for mounting the pressure sensor and the second arm being for filling and sealing the sensing medium.

[0019] In one embodiment, the introduction material is integrated with the proximal end housing, the introduction material has a first portion that is an extension of the proximal end housing, and the air lumen, the tether of the carrier material, and the electrical wires are connected to the first portion. The introduction material has a second portion that interfaces with the first portion, and the second portion functions as a buffer flexure for the carrier material.

[0020] In one embodiment, the Transport material further includes an intermediate air tube and a coil, the air lumen being housed in the intermediate air tube, and the coil being located between the air lumen and the intermediate air tube.

[0021] In one embodiment, the carrier further comprises an outer tube, the air lumen and intermediate air tube being housed within the outer tube, and the electrical wires being covered by the outer tube.

[0022] In one embodiment, the tether is attached to the outer tube.

[0023] In one embodiment, the carrier further comprises a rigid drive connector located at a proximal end of the carrier, the carrier being connected to a drive, the rigid drive connector being connected to the drive.

[0024] In one embodiment, the rigid drive connector has a number of electrodes flush mounted thereon that are welded to the wires.

[0025] In one embodiment, the introduction material is Distal Housing and the introduction material is integrated with Distal HousingThe introduction material further includes a second portion that is linked to the first portion, and the second portion is a pressure-relieving portion that functions as a buffer flexure for the carrier. Sensors A ventricular assist device with a built-in

[0026] In one embodiment, the Proximal End Housing and the above Distal Housing a pressure pump housing having a surface groove formed above the overlapping bonding area; Sensors A ventricular assist device with a built-in

[0027] In one embodiment, the groove is sealed with a waterproof potting material. [Brief description of the drawings]

[0028] [Figure 1] 1 is a schematic diagram of a para-aortic blood pump device according to a first embodiment of the present invention. [Diagram 2] FIG. 4 is a schematic diagram of a para-aortic blood pump device according to a second embodiment of the present invention. [Diagram 3] FIG. 11 is a schematic diagram of a para-aortic blood pump device according to a third embodiment of the present invention. [Figure 4] FIG. 11 is a schematic diagram of a para-aortic blood pump device according to a fourth embodiment of the present invention. [Diagram 5] 1 is a schematic diagram of a para-aortic blood pump device attached to a human body according to a first and second embodiment of the present invention. FIG. [Figure 6] FIG. 13 is a schematic diagram of a para-aortic blood pump device attached to a human body according to the third and fourth embodiments of the present invention. [Figure 7] FIG. 2 is a first schematic diagram of a drive unit according to the embodiment of the present invention. [Figure 8] FIG. 2 is a second schematic diagram of a drive unit according to an embodiment of the present invention. [Figure 9] FIG. 2 is a schematic diagram of the driver functions and major interconnect signals required for the operation of the present invention. [Figure 10]FIG. 13 is a schematic diagram of driver functions and major interconnect signals required for operation of the third embodiment of the present invention. [Figure 11] FIG. 11 is a schematic diagram of the main interconnection signals of the driver functions required for operation of the second embodiment of the present invention. [Figure 12] Figure 1 illustrates the electro-mechanical actuator (EMA) piston position trajectory and timing of trigger detection commands associated with the reverse pulsation cycle assistance. [Figure 13A] FIG. 1 is a perspective view of a para-aortic blood pump implant according to the first or third embodiment of the present invention. [Figure 13B] FIG. 2 is a cross-sectional view of a para-aortic blood pump implant according to the first or third embodiment of the present invention. [Figure 14A] FIG. 1 is a perspective view of a para-aortic blood pump implant according to the second or fourth embodiment of the present invention. [Figure 14B] FIG. 1 is a cross-sectional view of a para-aortic blood pump implant according to the second or fourth embodiment of the present invention. [Figure 15] Another embodiment of the present invention is a connection between a carrier and a pump housing of a blood pump, the connection of the carrier being made by an introducer on the distal housing. [Figure 16] FIG. 16 is a cross-sectional view of the blood pump shown in FIG. [Figure 17] FIG. 13 shows a shallow groove design for running electrical wires from an inlet in the distal housing to the pressure sensing chamber in the proximal housing. [Figure 18A] 13 shows the outer end of the blood pump using an interface adapter connector and connecting the opposing mating artery to the artery. [Figure 18B] 1 shows the coupling of the blood pump of the present invention to the artery via an insert type connection method using a T-shaped intravascular connector coupled via an interface adapter. [Figure 19] 1 shows a cross-sectional view of a body of revolution of a stem assembly including a unitary axisymmetric elliptical blood sac and sac, a proximal stem and a distal stem. [Figure 20]Exploded view showing the components that make up the axisymmetric elliptical blood sac and stalk assembly (note, the sac is in its original shape before being joined together at the proximal end and distal stalk shown in FIG. 3). [Figure 21] FIG. 19 shows the structure of the bent trilobal pouch at the end of the blood pouch injection. [Figure 22] 1 shows a perspective view of a carrier material connected via an introducer material to a proximal end housing of a blood pump. [Figure 23A] 23 shows a cross-sectional view of the distal end of the blood pump and carrier taken along section AA of FIG. 22. [Figure 23B] 23 shows a cross-sectional view of the proximal end of the carrier along section AA of FIG. 22. [Figure 24] FIG. 13 shows a cross-sectional view of an exhaust port attached to a proximal end housing according to the first embodiment. [Figure 25A] 1 shows a cross-sectional view of the pressure sensing chamber and introducer in the proximal housing of the first embodiment. (Note: the carrier is not attached and the introducer includes a first portion, an extension of the proximal housing, and a second portion associated with the first portion.) [Figure 25B] FIG. 25B shows a perspective view of an integrated MEMS pressure sensor. [Figure 26] 1 shows a cross-sectional view of a multi-layer carrier material of the present invention, including an inner tube for air transport, a middle tube for electrical signal transmission, a coil, a tether, and an outer tube. [Figure 27] FIG. 11 is a cross-sectional view showing a design proposal for a multi-chamber conveying material. [Figure 28A] 1 shows a typical diagram of the flow characteristics during the pump filling stage. [Figure 28B] FIG. 2 is a diagram showing a schematic flow characteristic of a pump discharge stage. [Figure 29] FIG. 2 is a perspective view of a T-shaped flow connector according to the present embodiment. [Diagram 30] FIG. 2 is a cross-sectional view of a T-shaped flow connector of the present embodiment. [Diagram 31] This is an expanded plan view of an inserted metal stent made of nickel-titanium alloy. [Diagram 32]Define the lateral stiffness (LS) of the insertion catheter to measure the nickel-titanium alloy metal stent and T-shaped flow connector. [Diagram 33] FIG. 2 is an exploded schematic diagram of the inside of the coupler and its components. [Figure 34A] FIG. 2 is a schematic diagram of a coupler in an open state (configuration). [Figure 34B] FIG. 2 is a schematic diagram of a coupler in a locked configuration. [Diagram 35] FIG. 1 is a cross-sectional schematic diagram of an aortic adaptor and a para-aortic blood pump connected by a coupling. [Figure 36A] FIG. 1 is a schematic diagram showing step discontinuities caused by the docking method. [Figure 36B] FIG. 1 is a schematic diagram showing gap discontinuities caused by the docking method. [Figure 37] FIG. 1 is a schematic diagram of an inlet adapter that is attached distally to an aortic bypass pump. [Figure 38] FIG. 4 is a cross-sectional view of the inlet adapter. [Figure 39] Shown is the downward tapered beak of the inlet adapter that connects to the angled (slanted) surface of the neck of the T-shaped flow connector. [Diagram 40] FIG. 13 is a schematic diagram of a crimp flow connector arranged to be wrapped with a tie (wrapped configuration). [Figure 41A] 1 shows an insert flow connector inserted through an access hole formed in the aortic wall. [Figure 41B] 1 shows the coiled flow connector fully inserted into the aortic lumen. [Figure 41C] 1 shows the compression style flow connector repositioned with its T-neck facing the aortic access hole. [Figure 41D] 1 shows the flow connector in an expanded, deployed form, with the T-neck popping out of the aortic access hole after the ties are released. [Diagram 42]FIG. 1 shows an illustration of the steps of implanting an aortic adapter into the aortic segment of interest and connecting it to a blood pump. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The following provides four embodiments for realizing the para-aortic blood pump device according to the present invention, as follows:

[0030] Referring to FIG. 1, there is shown a schematic diagram of a para-aortic blood pump system according to a first embodiment of the present invention. The para-aortic blood pump system 10 includes a blood pump 12 and an aortic adapter The blood pump 12 includes a blood pump 14, a drive catheter 16, and a drive unit 18. The blood pump 12 further includes a pump housing and a pressure sensor. The interior of the pump housing is configured with two chambers, one for storing blood and one for receiving drive air. Chamber The aorta is partitioned by an egg-shaped flexible film that is suspended by a pair of stress-relief stems connected to the pump housing. A pressure sensor is mounted within the pump housing of the blood pump 12 to monitor the blood pressure within the blood pump 12 and generate an electronic blood pressure signal. adapter Reference numeral 14 denotes a flow manifold in the form of a valveless T-manifold shaped conduit that connects the blood pump 12 to the human aorta. In the first embodiment, the aorta adapter 14 and the blood pump 12 are integrally molded to have seamless blood contact surfaces, and the aorta adapter The blood pump 12 is connected to the human aorta via a blood vessel 14. adapter The aortic stent 14 is made of a flexible material and can be deformed when it is inserted into a circular hole formed in the aortic wall and transported. adapter 14 can expand and unfold by itself after insertion into the aorta, and is extremely tight fitting (oversize fitting). adapterThe drive catheter 16 is strong enough to withstand the radial compressive contact force of the aortic lumen on the wall of the blood pump 12. The drive catheter 16 is connected to the housing of the blood pump 12 and provides air pressure pulses to the blood pump 12 and transmits the blood pressure signal received from the pressure sensor. The drive section 18 is coupled to the drive catheter 16 to receive the transmitted electronic blood pressure signal, and includes an electromechanical actuator that generates air pressure pulses based on the electronic blood pressure signal, which is sent to the blood pump 12 via the drive catheter 16. The wearable actuator 18 provides a heart rhythm-linked air pressure pulse control law to drive the blood eject and fill of the implanted blood pump 12.

[0031] The aforementioned driving unit 18 includes a battery power supply system 11 and a backup battery power supply system (similar or identical to the battery power supply systems 21, 31, and 41 in the following Figures 2 to 4 and 8), among which the backup battery power supply system ensures a continuous power supply for the driving unit 18. When the patient does not need to move, it is convenient to use the AC adapter The drive 18 may also be powered via a power supply. The device may also include a clinical monitor, shown in Figures 2-4, that may be connected to the drive 18 and provide a user interface for the clinician to monitor the device, display diagnostic messages, and access drive parameters for initial start-up configuration of patient data and optimization of specific therapy operating mode settings.

[0032] 1 and 2 show two different blood pump designs 12, 22 that are systematically coupled to the same drive catheters 16, 26 and drive sections 18, 28. FIG. 2 is a schematic diagram of a para-aortic blood pump apparatus 20 according to a second embodiment of the present invention, which differs from the first embodiment of the present invention in that the para-aortic blood pump apparatus 20 according to the second embodiment has a coupler 25, or coupling. adapter The blood pump 22 and the aorta in the second embodiment are further provided with a coupling adapter. adapterThe blood pump 22 is connected to the aorta. adapter A coupler 25 is provided for coupling to the aorta 24. The coupler must be carefully designed to minimize discontinuities at the connection interface. During implantation of the device, the aorta adapter The device is first inserted into the aorta through a hole cut into the aortic wall. adapter A coupler 25 may be fitted around the T-neck of 24 to allow connection of blood pump 22 to coupler 25. After blood pump 22 is placed in the thoracic cavity, the blood pump 22 is coupled to the aorta via coupler 25. adapter The detachable blood pump 22 and the aorta are then firmly locked together. adapter The 24 design offers advantages during and after the implantation procedure. During implantation of the device, the detachable blood pump design allows the aortic adapter The implantation of the pump is easier because the surgical area is clearer and there is no interference from the pump body. In addition, after the implantation operation, the pressure Sensors In the event of an emergency surgical replacement due to a malfunction of the aorta or a rupture of the blood sac, the blood pump can be removed and replaced. In this respect, the detachable blood pump design of the second embodiment is advantageous. adapter can be left in the aorta without being removed, adapter This avoids the troublesome and risky redosurgery involved in removing the graft.

[0033] Please refer to Fig. 1 and Fig. 3. It is a schematic diagram of the para-aortic blood pump device 10, 30 of the first embodiment and the third embodiment of the present invention. The third embodiment is different from the first embodiment of the present invention in that the driving catheter 16 of the first embodiment is replaced by the distal driving catheter 37, the driving catheter interconnector 33, and the proximal driving catheter 39 of the driving catheter 36 of the third embodiment. The distal driving catheter 37 is connected to the driving catheter interconnector 33 so as to transmit the electronic blood pressure signal acquired from the pressure sensor and the air pressure pulse transmitted from the driving unit 38. In addition, the driving catheter controller and the vibrator (for alarm warning) built in the driving catheter interconnector 33 are originally built in the driving unit 18 of the first embodiment, so the driving unit 18 of the first embodiment has a driving catheter controller and a vibrator added (compare with the driving unit 38 of the third embodiment). The driving catheter controller is used to process the electronic blood pressure signal, and the vibrator is used to provide audio warning and tactile feedback. In other words, the mechanical power transmission of the blood pump, as well as the analog / digital signal conversion and alarm notification, realized by the driving catheter 16 and driving unit 18 in the first embodiment are basically the same as those realized by the distal driving catheter 37, driving catheter interconnector 33, and proximal driving catheter 39 in the third embodiment.

[0034] The first embodiment has a simpler drive catheter arrangement design, and also has an electronic signal processor installed in the drive section, which can minimize the risk of environmental contamination (water or moisture condensation) on pressure signal measurement related to the drive catheter interconnector 33 and air leakage at the joint. However, such long-type drive catheters are prone to contact damage such as abrasion, kinking, and cuts due to contact with foreign objects during daily activities. If there is significant damage to the drive catheter 16 of the first or second embodiment, both electronically and mechanically, it may be necessary to replace the blood pump through surgery. Considering the risk of redoing the surgery and the associated medical costs, this is highly undesirable. The third or fourth embodiment employs an intermediate connector (drive catheter interconnector) to reduce the disadvantages of blood pump replacement related to such drive catheter breakage. In general, the distal drive catheter 37 has a shorter length exposed outside the body, and the skin dressing or the cover of the patient's vest is better protected through the drive catheter interconnector 33. In the extreme case where the driving catheter is severely damaged and cannot be repaired, the proximal driving catheter 39, which is most likely to be damaged, can be easily replaced without resorting to surgery. Also, the third or fourth embodiment is not susceptible to electromagnetic interference because the analog-to-digital signal conversion has already been completed within the circuit of the driving catheter interconnector 33. In the third or fourth embodiment, the fidelity of the pressure signal can be better ensured because the digital signal transmission within the proximal driving catheter 39 is not sensitive to electromagnetic interference.

[0035] 3 and 4 are schematic diagrams of para-aortic blood pump devices 30 and 40 according to a third and fourth embodiment of the present invention, respectively. The third embodiment differs from the fourth embodiment in that the aortic adapter The blood pump 32 and the aorta in the fourth embodiment are integrally formed. adapter The fourth embodiment is similar to the second embodiment except for the blood pump 22 and the aorta. adapter 24, and coupler 25. The same blood pump 42, aortic adapterHere, redundant explanations will be omitted for 44 and coupling 45. Distal driving catheter 47, driving catheter interconnector 43, and proximal driving catheter 49 included in driving catheter 46 are similar to distal driving catheter 37, driving catheter interconnector 33, and proximal driving catheter 39 of driving catheter 36.

[0036] Referring to Figure 5, a schematic diagram of a para-aortic blood pump system mounted on a human body in accordance with an exemplary embodiment of the present invention. The para-aortic blood pump system 90 includes a blood pump 92 and a blood supply to the aorta. adapter 94, a drive catheter inner segment 991, a drive catheter outer segment 993, and a drive section 98. In another embodiment, the para-aortic blood pump system further comprises a coupler. The portion of the para-aortic blood pump system 90 that is implanted in the body includes a blood pump 92, an aortic adapter 94, and the drive catheter inner segment 991. In another embodiment, the para-aortic blood pump further comprises a coupler. adapter 94 is attached to the aorta 95 to create a drive catheter exit site EX at an appropriate location on the human skin. The extracorporeal segment of the para-aortic blood pump device 90 includes a drive catheter extracorporeal segment 993 and a drive unit 98. Across the exit site EX, a segment of the drive catheter internal segment 991 is covered with fabric velour to promote tissue ingrowth of the subcutaneous tissue and achieve infection control. The implanted velour is optimally placed 2-5 cm subcutaneously from the exit site EX. The drive unit 98 is a wearable or portable device.

[0037] Referring to Figure 6, a schematic diagram of a para-aortic blood pump system worn on a human body according to an exemplary embodiment of the present invention. The para-aortic blood pump system 90 includes a blood pump 92 and an aortic adapter94, a distal drive catheter 97 (including a drive catheter internal segment 971 and a drive catheter external segment 973 outside the body), a drive catheter interconnector 93, a proximal drive catheter 99, and a drive section 98. In another embodiment, the para-aortic blood pump apparatus 90 further comprises a coupler. The portion of the para-aortic blood pump apparatus 90 implanted in the body includes a blood pump 92, an aortic adapter 94, and includes a drive catheter inner segment 971. In another embodiment, the para-aortic blood pump system further includes a coupler. adapter 94 is fitted within the aorta 95 to create a drive catheter exit site EX at an appropriate location on the body epidermis. The portions of the para-aortic blood pump apparatus 90 located outside the body include the drive catheter extracorporeal segment 973, the drive catheter interconnector 93, the proximal drive catheter 99, and the drive section 98. The exit site EX is the boundary of the drive catheter, and the distal drive catheter is divided into the drive catheter intracorporeal segment 971, which is covered with velvet for infection control, and the drive catheter extracorporeal segment 973. The drive section 98 is a wearable or portable device.

[0038] The embedded subsystem is described in more detail below.

[0039] Implantation is accomplished through a relatively small chest opening via a left thoracotomy using lessinvasive surgical (LIS) techniques. adapter A main chest incision is made at the 7th rib space to allow implantation of the thoracic sac and blood pump. Two other smaller incisions are made between the 6th and 8th ribs, one each for the proximal and distal ribs. Distal The area between the aortic clamps is the aortic adapter This allows the catheter to be implanted through a hole in the aortic wall. adapter is flexible and can be curled and reduced to a small delivery configuration prior to implantation. Once implantation into the aorta is complete, adapterThe endothelial cell automatically bounces back to its original shape and has a strong adhesion to the lumen of the intended implant site. adapter The material is important and should be flexible, but the implanted aorta adapter The aorta has sufficient radial strength to keep its walls circular and to prevent buckling of the walls. adapter As a candidate material, silica gel or polyurethane elastomer can be selected, and reinforced polymer structures or metal materials can be embedded to enhance the structural strength.

[0040] The following describes each aorta in the above examples. adapter and its functional requirements will be further explained.

[0041] Hemodynamically, the aorta adapter The aorta provides a link between the blood pump and the systemic circulation of the body. adapter The blood pump is adapter It can also be used as a mechanism base for fixing to the aorta. adapter The structure must be elastic, yet anti-buckling, and strong enough to withstand the internal blood pressure and external contact forces generated by the blood pump contacting the surrounding lung tissue and by breathing and thoracic diaphragm movement.

[0042] Aorta adapter54 is embedded in the aorta, and the boundaries between the two catheter ends (catheter end 545, catheter end 645) and the aortic lumen form a host / graft interface in the bloodstream (see Figs. 13B and 14B). In order to morphologically and elastically minimize the discontinuity of the host / implant interface, the two catheter ends (catheter end 545, catheter end 645) are arranged to have a flared inner surface contour and a continuously tapered wall thickness distribution. This catheter end design minimizes the step at the interface and provides the necessary compliance matching effect at the time of connection to the aorta. adapter The design incorporates a thin catheter wall structure. This significantly reduces the possibility of thrombus formation at the boundary because the rate of clotaggregation of the boundary clot is slower than the rate of natural thrombolysis provided by the human aortic endothelium. In addition, the gradually thin catheter wall structure makes the catheter end (catheter end 545, catheter end 645) softer (conformable), and the catheter end expands and contracts in response to pulse pressure, creating a dynamic sealing effect to prevent blood cells from getting caught in the gaps at the boundary, which are usually the source of thrombus formation.

[0043] The drive units of the above embodiments will now be described in further detail.

[0044] 7 and 8 are perspective views of the right and left sides of the drive unit 78. The internal modules of this compact drive unit 78 include an electromechanical actuator (EMA), an electronic controller, a pair of main batteries, and a backup battery. The drive unit 78 also includes, as shown in FIGS. 7 and 8, User Interface It includes a panel 73, a battery hatch 71, a driving catheter socket 75, an external power socket 77, and a pair of ventilation holes 79.

[0045] Drive unit 78 User InterfacePanel 73 displays important messages during operation and warnings regarding device failures and aortic pressure status. If the main battery runs out of power, it can be replaced through battery hatch 71. If the patient is lying in bed and power from a wall socket is available for long-term use, a cable is used to power the drive 78 through a connection to an external power socket 77. A proximal drive catheter 99, one end of a drive catheter external segment 993, and a voltage sensor signal and air pressure pulse are connected to the drive 78 through the drive catheter socket 75. A pair of vents 79 are attached to the opposite side of the drive section 78 to allow outside air to pass through the inside of the drive section 78 for cooling purposes.

[0046] The drive unit 78 is externally connected to a clinical monitor. controller The clinical monitor unit can collect and display real-time clinical waveform data and store patient data for long-term condition monitoring and diagnosis. The clinical monitor unit also provides a User Interface can be provided, which can display device monitoring / diagnostic information and be used to set drive parameters and initially activate the drive 78 to optimize the patient-specific personal circulatory assist operating mode.

[0047] In the embodiment of the present invention, the EMA is an air actuator, which is composed of a brushless servo motor, a ball screw unit, and a piston. Cylinder The assembly includes a pump assembly having a pump head and a pump pump suction mechanism, and a pump pump suction mechanism.

[0048] The air actuator device is located in the drive unit and is carried by the person receiving treatment from the device. The electromechanical actuator is a brushless servo motor, a piston and CylinderThe assembly includes a ball screw unit. The ball screw unit includes a ball screw post and a ball nut. The piston is fixed to the end of the ball screw post, and the rotation of the nut causes the screw post to move linearly back and forth. The servo motor includes a rotor and a stator, and the rotor and the ball nut are integrated. Through the electromagnetic induction of the motor, the rotor rotates, and the screw post and the piston move through clockwise and counterclockwise direction changes. Cylinder The piston stroke achieves a linear reciprocating stroke motion within the drive Cylinder The air within the blood sac is then pumped through the drive lead to the blood pump, completing the hemorrhage and filling action of the blood sac.

[0049] Using air as a medium to drive a blood pump faces two problems: gas leakage, and water condensation caused by blood seeping into the blood sac wall. The former impairs the blood pump's blood injection and blood flow performance and the motor's power consumption, while the latter poses the risk of bacteria being generated inside the drive cord due to moisture. To solve these two problems, the air actuator of this ventricular assist device is specially equipped with a pressure balance valve device on the cylinder wall. This valve allows Cylinder The air mass formed by the mutual communication between the air inside and the atmosphere can circulate between them during the air pressure equilibrium process. The air actuator is equipped with position and optical sensors that allow the controller to obtain piston position information, issue a piston drive command from the controller to drive the reciprocating motion of the piston, and operate the pressure balance valve. Therefore, the timing and frequency of opening the pressure balance valve can be programmed and stored in the controller. The operation of this pressure balance valve allows: Cylinder The internal air is exchanged with the external air, achieving the functions of ventilation and drying gas, and further ensuring the operational safety and performance of the present ventricular assist device.

[0050] Please refer to FIG. 9. The para-aortic blood pump device according to the embodiment of the present invention is divided into three parts. The first part is mainly installed inside the human body, i.e., implanted, and its outer end communicates with the second part. The first part includes a blood pump (including a blood pump pressure sensor) implanted in the human body, a para-aortic blood pump (including a blood pump pressure sensor), and a para-aortic blood pump (including a blood pump pressure sensor). adapter , and a distal drive catheter segment. The second part is mounted outside the body and includes a proximal drive catheter and a drive catheter electronics module (also called a drive catheter interconnect). The third part is mounted outside the body and is the drive section, which includes the electromechanical actuator (EMA), controller circuitry, main battery, and backup battery.

[0051] Blood Pump Pressure Sensors is built into the proximal blood pump housing, Sensors A small pressure vessel filled with a sensing medium Sensors The blood pump is immersed in the chamber and can continuously monitor the blood pump pressure. Distal Drive Catheter is connected to the pump housing and provides counter-pulsating air pressure pulses for dynamic ejection and blood sac filling. The distal and proximal actuation catheters provide air pressure pulses to the blood pump, generated by the EMA inside the actuator; the pressure of the sphygmomanometer Sensors The electronic blood pressure signal generated by the aorta is sent to the driving unit. The driving air circuit (indicated by the dashed arrow) and the communication signal path (indicated by the solid line) are shown in Figure 9 to explain the functional relationship between the interactive working modules. adapter The details of the controller circuit have been described above. The controller circuit includes a motor controller unit for driving the brushless motor and a microcontroller unit as a central processing unit, and can process the received pressure signal and generate a control command for the motor controller so that the piston operates.

[0052] 10 and 11, a schematic block diagram of the internal drive function and the important interconnection signals required for the activation of the blood pump is shown. A further description of the proposed embodiment of the present invention is shown in Fig. 10 and 11. To explain the drive relationship between the external drive and the implant, the blood pump, the drive catheter, the distal drive catheter, the proximal drive catheter, the aortic adapter and the contents of the drive catheter interconnect.

[0053] The drive unit receives a pressure signal (electrical signal) from the blood pump, Trigger A trigger detection algorithm is used to process this signal and, in conjunction with the heart rate, command the motor actuator to operate. Trigger After receiving the specified trigger time, the microcontroller unit sends a command to the motor controller (unit) to drive the piston and provide reverse pulsation cycle support during the process from injection to filling or from filling to injection.

[0054] The electronic controller architecture consists of three functional blocks: a microcontroller unit (MCU), a motor controller block (or motor controller unit), and a power management unit. The following table provides an overview of each functional block of the drive 78: TIFF0007650542000001.tif183159

[0055] 10 and 11, the exemplary embodiment disclosed above illustrates signal collection, transmission, processing, and generation of control logic and instructions, and how the electromechanical actuator operates to generate air pressure pulses to drive the blood pump.

[0056] FIG. 12 shows the trigger detection command of the piston position of the electromechanical actuator related to counterpulsation assist. In FIG. 12, the aortic pressure (AoP) waveform without assistance is shown in dotted line, and the aortic pressure waveform with assistance is shown in solid line. When the drive is operating in automatic operation mode, the drive operation is activated and the system executes a “fill-inject-fill-inject…” cycle assist. This represents a normal synchronous counterpulsation assist operation. The MCU monitors the blood pump pressure (BPP) signal (electrical signal) and detects the timing of left ventricular end diastole (LVED). Upon detecting the LVED timing, the MCU generates an F_Trig signal. The time interval between two consecutive F_Trig signals represents the instantaneous cardiac cycle interval (or period). Based on the estimated cardiac rate calculated from the interval of several cycles going forward, the MCU determines the blood pump ejection time, i.e., the E_Trig signal. The E_Trig signal provides the timing that commands the motor controller unit to drive the electromechanical actuator based on a predefined position, velocity, and acceleration curve. Once the ejection stroke is complete and the optimal dwell time has elapsed, the electromechanical actuator is commanded to perform a prefill operation at a slow fill velocity until the F_Trig signal is received. After receiving the F_Trig signal, the electromechanical actuator begins to perform the remainder of the fill stroke at the specified piston velocity.

[0057] If the MCU loses the BPP signal (electrical signal) sent from the blood pump, the MCU automatically activates the flushing mode to drive the electromechanical actuator and operate at the predetermined auxiliary frequency and volume pacing amount of the driver. The flushing mode is an equipment protection mode to prevent clot formation in the blood sac without providing synchronous counterpulsation circulatory support.

[0058] In principle, the para-aortic blood pump device of the present invention has a better counterpulsation support effect than intra-aortic balloon pump (IABP) due to the feature of non-occlusive aortic placement. Unlike bedridden or ambulatory IABP patients who have to stay in hospital, the para-aortic blood pump device of the present invention allows patients to leave the hospital and live a better life at home. Therefore, the para-aortic blood pump device of the present invention can obtain economic benefits from a shorter hospital stay, and further improve the disease status and quality of life of patients.

[0059] In recent years, the trend of LVAD use has been saturated, mainly because its application has only been applied to a small group of patients with end-stage heart failure. The application of early intervention LVAD therapy to patients with mild heart failure has long been a clinical goal of cardiac medicine. If early intervention therapy is possible, it is expected that this will have a significant impact on the expanded use of LVAD therapy and influence the future progress of cardiac medicine. Clinical evidence shows that providing LVAD support at the moderate to severe heart failure stage can improve some patients with non-ischemic cardiomyopathy by improving cardiac function through reverse remodeling of cardiomyocytes and causing sustained myocardial recovery. However, such early intervention intention must rely on two favorable driving factors: a simple and safe surgical procedure and an effective adaptive circulatory support treatment plan as the disease progresses. Continuous VAD support is non-physiologic and takes the supported heart off the normal path of health recovery. However, counterpulsation support is physiological and provides systolic contraction relief and diastolic perfusion gain to promote reverse remodeling of myocardial tissue and achieve therapeutic goals. In conclusion, the therapeutic strategy provided by this para-aortic blood pump invention meets the evolving conditions of early intervention trends in cardiac medicine. The beneficial attributes of therapeutic efficacy provided by the para-aortic blood pump device, such as adaptive partial-support, minimally invasive surgery, and counterpulsation therapy, make this invention a potential candidate to help advance the treatment of heart failure in the future.

[0060] The blood pumps of the above embodiments will be further described below.

[0061] 13A and 13B are schematic and cross-sectional views of a para-aortic blood pump device installed in a human body according to a first and third embodiment of the present invention. The implanted subsystems of the para-aortic blood pump device include a blood pump 52, an aortic adapter54, and a drive catheter (or distal drive catheter) 57 connected to the blood pump 52. The blood pump 52 includes a rigid or semi-rigid housing 52h and a blood sac 529, the proximal end of which is closed, Distal end The aorta is opened and adapter 54. Among them, the blood sac 529 is composed of the utricle membrane 526, and the blood sac 529 is fixed to the proximal end housing 523 of the housing 52h via the proximal end port 530. Distal Port Rigid housing 52h through 540 Distal Housing 525. Within the housing of the blood pump 52, a blood chamber B and an air chamber A are separated by an egg-shaped flexible membrane 526, which has a pair of stress-relief stems (proximal end port 530, Distal Port The rigid housing 52h is suspended through a pressure sensing mechanism 527 (or blood pressure sensor) hermetically fitted in the proximal end housing 523 of the rigid housing 52h. The blood chamber B is for storing blood, and the air chamber A is for receiving the driving air. The pressure sensing mechanism 527 (or blood pressure sensor) is hermetically fitted in the proximal end housing 523 of the rigid housing 52h, and the detected pump pressure is transmitted through the sac membrane 526, propagates through the incompressible liquid or gel contained in the sealed pressure sensing chamber 528, and finally received by the pressure sensing mechanism 527. After receiving the detected blood pump pressure, the pressure sensing mechanism 527 generates an electronic blood pressure signal. The size and shape of the implantable subsystem assembly are designed in an implantable form and are applied to patients with a body surface area (BSA) of 1.2 square meters or more.

[0062] 14A and 14B are schematic and cross-sectional views of a portion of a para-aortic blood pump system attached to a human body according to a second and fourth embodiment of the present invention. The implanted subsystem of the para-aortic blood pump system includes a blood pump 62, an aortic adapter 64, a coupler 65, and a drive catheter (or distal drive catheter) 67 connected to the blood pump 62. The coupling 65 couples the blood pump 62 to the aorta. adapter64 to enter the vascular system of the person implanting the device. The blood pump 62 includes a rigid housing 62h, which further includes Proximal End Housing 623 and a distal housing 625. The blood pump 62 has a structure in which an opening OP is adapter The coupler 65 is similar to the structure shown in FIG. 14B, except that it is separate and independent from the aortic adapter 14B。 The design and basic design principles of the blood pump will be further described below using the design disclosed in Figure 14B.

[0063] Referring to Figure 13B, the blood pump 52 includes a molded rigid housing 52h, which further includes a Proximal End Housing 523 and distal housing 525. The rigid housing 52h is adapter The blood pump 52 has a single opening OP connected to the aorta 54 and into the vascular system of the patient. adapter 54 and seamlessly manufactured, aortic adapter 54. Such an integrated blood sac 529 and aorta adapter The assembly 54 is connected to the blood pump 52 via a proximal end port 530 and Distal Port 540 is bonded to the proximal end housing 523 Distal Housing 525. The blood sac 529 is connected to the non-flexible disk portion. Proximal End Housing 523 so as to be bonded to the central pressure-sensing chamber 528 of Proximal End Housing It is fixed to the top of 523.

[0064] A miniaturized pressure sensing mechanism 527 is housed in the proximal housing 523 and is in fluid communication with a closed pressure sensing chamber 528. This device allows for continuous monitoring of blood pressure in a blood sac 529. Because the pressure sensing mechanism 527 does not come into contact with blood, the protection of the rigid housing 52h ensures long-term sensor reliability and fidelity, as the rigid housing 52h helps isolate the pressure sensing mechanism 527 and its circuitry from the effects of chemical corrosion and protein adhesion due to direct blood contact.

[0065] The end of the driving catheter 57 is Distal Housing 525 to provide a counterpulsation dynamic pressure pulse for ejecting or injecting blood from the blood pump 52. The design of the actuation catheter can be multi-cavity or multi-layered to encase the wires used for transmitting the pressure signal. The kink resistance of the distal actuation catheter 57 can be enhanced by adopting metal coils or woven nets or nets as the catheter wall reinforcement member. The overall geometry of the flow path in this blood pump is relatively wide, and the valveless aorta is adapter The design and operation of the pulsatile blood pump constitutes excellent blood processing characteristics, avoiding hemolysis due to high shear forces and clot formation or thromboembolism due to low flow rates.

[0066] The innovative design of the blood pump 52 and blood sac 529 described above makes the sac membrane 526 extremely durable. The blood sac 529 is an ovoid membrane rotating body that rotates around the centerline of the blood pump 52 and has two polymer ports (proximal end port 530, Distal Port 540) are coupled to the rigid housing 52h, each configured as a disc or ring, which acts as a bending / tensile stress relief mechanism to reduce stress concentrations when connected to the rigid housing 52h. During the process of pumping blood from the blood pump, the cystic membrane 526 is compressed or folded into a tri-lobe shape, in which the maximum strain is usually at the ports (proximal end port 530, Distal Port540) occurs at the creases close to the edge of the port. Such high local membrane stress / strain resulting from large deformation of the film is absorbed / cancelled by the flexible suspension deformation of the port edge. Of particular note is that the position of the trefoil fold mode is not fixed, the deformation of the film is influenced by the gravity direction, and the crease position occurs randomly. In fact, the patient's body posture and orientation may change from time to time during daily activities, including postures of standing, lying down, sitting, and exercising. Therefore, the gravity effect acting on the volume of blood stored in the blood pump 52 constantly changes direction, resulting in the formation of non-fixed creases. Such randomly formed thin film overlap line characteristics constitute the unique fatigue resistance characteristic of the present invention. The present blood pump 52 is expected to have a longer durability than conventional fixed folded yarn film designs.

[0067] The folding and expansion of the sac membrane is closely related to the vortex structure mode contained in the blood sac 529. The characteristic of the design of the blood sac described above is that the folding lines are randomly formed, and the vortex structure characteristics occur alternately with the change in the pattern of the folded membrane. Therefore, the cleaning effect in the blood pump 52 is strong, unsteady, and characterized by random wandering vortex motion. Such randomness of the blood pump vortex structure helps to wash the blood contact surface of the entire blood sac without generating fixed low-speed reflux areas near the membrane wall and in the fold area. In animal experiments, it was observed that the blood pump of the present invention has a very strong anti-thrombotic ability.

[0068] Each distal drive catheter in each embodiment is further described below.

[0069] 5 and 6 are schematic diagrams of a driving catheter 96 connecting a blood pump 92 and a driving unit 98. Distal measurement drive catheter 97 (which drives the catheter body 991) pneumatically connects the blood pump 92 to an electromechanical actuator housed within the drive section 98, and transmits an electrical signal obtained from the blood pump pressure sensor mechanism 527 (see FIG. 13). Distal measurement drive catheterOne end of 97 (drive catheter internal segment 991) is connected to the blood pump housing and the other end has a small external connector for air transmission and electrical communication. Distal measurement drive catheter 97 (drive catheter inner body segment 991) passes subcutaneously and exits through the skin under the protection of a protective cap. Distal measurement drive catheter The outer diameter of 97 (drive catheter inner body segment 991) is designed to be small and the tubing is radial to minimize stress at the exit site EX and provide comfort to the patient. Distal measurement drive catheter A portion of 97 (drive catheter internal segment 991) is covered with a porous fabric that promotes tissue growth into the fabric and makes the exit site EX infectious. The drive catheter external segment 973 exits the epidermis and is fixed a short distance away from the skin exit site EX.

[0070] A driving catheter internal segment 991 and a driving catheter external segment 993 and connector are designed to be sufficiently resistant to the tensile loads imposed during percutaneous surgery. After surgery, the actuation catheter internal segment 991 and the actuation catheter external segment 993 continue to be subjected to loads due to muscle movement, and the actuation catheter internal segment 991 and the actuation catheter external segment 993 are designed to be resistant to these fatigue loads. The exterior of the actuation catheter internal segment 991 and the actuation catheter external segment 993 are designed to be biocompatible and chemically resistant to cleaning agents and disinfectants during clinical use.

[0071] The proximal drive catheters of each of the above embodiments will now be described in further detail.

[0072] The driving catheter external segment 993 and the proximal driving catheter 99 are for connecting the driving catheter internal segment 991 and the distal driving catheter 97 to the driving section 98, respectively. The near driving section catheter 99 has a driving catheter interconnector 93 at one end and a driving section connector at the other end. The driving catheter interconnector 93 includes a circuit board that converts analog blood pump pressure signals to digital signals and a vibrator that provides tactile feedback in addition to the audio alarm. The driving catheter interconnector 93 has a flat shape to prevent the driving catheter external segment 973 from twisting when secured to the patient's skin. In addition, the driving catheter interconnector 93 and the driving catheter embedded wire are sealed and designed to prevent the ingress of water and moisture. The proximal driving catheter 99 is attached externally to allow replacement and maintenance when deemed necessary, so that if the proximal driving catheter 99 is damaged beyond repair, surgical replacement of the blood pump is not required.

[0073] Valveless blood pumps have two advantages in terms of blood processing characteristics. 1) There is no unpleasant valve sound and valve-induced blood cell disorder, thrombus formation and thromboembolism. 2) They have stronger antithrombogenicity. Bidirectional pulsating flow has a better surface cleaning effect, so that it can minimize protein adhesion and avoid the formation of blood clots associated with boundary discontinuities on artificial surfaces in contact with blood. The flow paths of pumps without valve pulsation are much more uniformly wide than those of valve pulsating or continuous flow rotary pumps. Hemolysis (red cell membrane rupture) usually occurs in narrow flow paths with high flow rate gradients, such as the gap between the valve annulus and leaflet of valved pulsating pumps. In addition, there are often low-speed recirculation and stagnation areas behind the open valve, which may promote the occurrence of thrombus. In contrast, in a nonvalvular pulsatile blood pump, the shear stress on blood cells is actually several orders of magnitude lower, the slow stagnation zones associated with valve geometry and motion are nearly eliminated, blood cell damage and platelet activation are reduced, clot formation and aggregation are reduced, and lower doses of anticoagulants can be used, resulting in easier and safer postoperative care.

[0074] 15 to 17 show schematic diagrams of a blood pump 62, a drive catheter 67, and an introducer 63 according to another embodiment of the present invention. In this embodiment, anatomical adaptability is emphasized to facilitate easier externalization of the blood pump and delivery.

[0075] As shown in FIGS. 15 and 16, the drive catheter 67 is Distal Housing 625. The blood pump 62 comprises an elliptical blood sac and stem assembly 659 (including sac 629 and stems 630, 640), a pump housing 62h (having a proximal end housing 623 and an inlet connector 6251). Distal Housing 625) and a pressure sensing system 628 fitted to the proximal housing 623. The previously described components, inlet connector 6251, pressure sensing system 628, and actuation catheter 67 are essentially the same or correspond to the assemblies / compositions of the previously described embodiments, and a detailed description of these assemblies and their functions will not be repeated here.

[0076] In this embodiment, the pump housing 62h Distal Housing The introduction material 63 is provided in 625, and the driving catheter 67 is connected to the pump housing 62h. The introduction material 63 is Distal Housing 625, which is configured in a body shape adjacent to the outer surface of the pump to tangentially connect the power transmission member to the outer surface of the pump. With such a through-body design, the design of the pump housing 62h is adapted to the anatomical space available for placement of the blood pump. Interface Adapter 501, the drive catheter 67 can be routed in an optimal orientation for smooth subcutaneous tunneling and skin exit, which is advantageous for anatomical adaptability to various implant site configurations.

[0077] In this embodiment, the introduction material 63 Distal Housing625 and locating the sensor 6271 (FIG. 25A) and pressure sensing chamber 628 within the proximal end housing 623 isolates the signal transmission path from the pneumatic communication path, and requires the blood pump 62 to be sealed to protect against ingress of biochemical fluids that could compromise signal transmission fidelity after device implantation.

[0078] Referring to FIG. 17, the pump housing 62h includes: Distal Housing 625 has a groove 621 formed on the outer surface of the proximal end housing 623 and Distal Housing 625 (FIG. 16) and the surface groove 621 is located above the overlapping joint area da with 625. The surface groove 621 is arranged so that an electric wire extends from the outlet of the inlet 63, and the electric wire reaches the electrode 6274 in the second space 6273 (FIG. 25B) along the surface groove 621 above the overlapping joint area DA. In some embodiments, the groove 621 is sealed by potting a waterproof material and / or an annular cap so as not to irritate or injure the tissue that it contacts.

[0079] As shown in Figures 18A and 18AB, the aorta connector 50 is usually Interface Adapter 501 is a connection mechanism used to connect the blood pump 62 to the target artery 60. Interface Adapter The connector 50 facing 501 Distal end 504 is placed in the vascular wall of the artery 60 and is connected to the body circulating fluid. connector 50 (or Interface Adapter 501) is smoothed to geometrically match the inlet configuration of the blood pump 62. interface Transition connector 50 (or Interface Adapter A coupler is usually required to couple the proximal end of the aortic septum 501 to the inlet of the blood pump 62. connector 50. Shown in Figure 18A is an end-to-end mating of a Dacron or PTFE graft 502 sutured to a target artery (or blood vessel) 60, which can be used in vascular surgery. In some other embodiments, such as the embodiment shown in Figure 18B, an intercalated aortic connector503, for example, a T-manifold type disclosed in U.S. Patent Application No. US2008 / 0300447A1, entitled "Dual-pulsation bi-Ventricular Assist Device" adapter It is.

[0080] 19 and 20 respectively show a longitudinally symmetrical elliptical blood sac and stem assembly 650 and its components. Polymeric materials for these components include, but are not limited to, segmented polyurethanes of various suitable hardnesses. The components of the sac and stem assembly 650 include a flexible membrane sac (blood sac) 629, a proximal stem 630, Distal stem 640, which in some embodiments are all integrally formed in an axisymmetrical configuration about a common centerline 62C of the blood pump 62. The proximal stem 630 is located at the proximal end 6291 of the blood sac 629, Distal stem 640 is the blood sac 629 Distal end Located at 6292.

[0081] FIG. 19 shows an integrated blood sac and stem assembly 650. Distal stem The end of 640 is the blood sac 629 Distal endand is bonded to the inverted membrane 62A. Figure 20 shows the components before bonding. Typically, the blood sac 629 is manufactured by dip molding, and the stems 630, 640 are manufactured by injection molding. There is no preferred azimuth angle for the deformation of the deflection sac. In theory, as shown in Figure 21, when the pressure difference on the membrane sac exceeds a certain threshold, the thin-walled sac with an axisymmetric elliptical structure will bend into a tri-valve shape 6293, and this bending of the membrane is only related to the final tri-valve shape 6293 (eigenmode), and the location of the fold 6294 or turn-back line that occurs there is determined by the initial disturbance that causes the bending instability. The uniformity of the thickness in the cross section cut by the center line (or rotation axis) 62C of the assembly 650 perpendicular to the blood pump 62 is important. Care must be taken to manufacture the sac with high precision to ensure the axisymmetric shape. In real life, the direction of gravity is the main factor for the beginning of the fold line. The posture of the recipient of the equipment constantly changes due to the patient's daily activities (e.g., standing, sitting, exercising, sleeping, etc.), and the direction of gravity relative to the blood pump direction also constantly changes. Therefore, the deformed folds 6294 of the sac appear in a random manner, and high strain folds are distributed non-stationarily throughout the sac. Therefore, avoiding leaving high strain areas in fixed positions is an important design criterion for a long life of the sac.

[0082] The present embodiment innovates a traveling fold line characteristic that causes high strain locations to appear in the membrane in a non-stationary manner to increase the fatigue life of the membrane sac. Thus, the detrimental stress concentration phenomenon often associated with a flexed blood sac is improved. Based on the inherent change in the behavior of this flex mode, the fatigue life of the membrane is significantly increased due to this non-stationary fold line formation characteristic, which distributes high strain areas throughout the sac. The beneficial results associated with this non-stationary sac deformation mode also depend on the enhanced vortex washing effect in the blood sac. The surface of the sac is washed more thoroughly, and irregular walking-like vortices are formed and traverse the entire vortex flow. This significantly reduces the possibility of constant low-velocity recirculation areas and fold line creases in the near-wall region, resulting in a long-life and anti-thrombogenic blood pump design.

[0083] 22, 23A and 23B show an exemplary embodiment of how the integration method is employed to attach the blood sac and stem assembly 650 to the pump housing 62h and connect the drive catheter 67 to the proximal end housing 623.

[0084] A blood sac 629 is attached to the proximal housing 623 to facilitate the filling and dispensing action of the pump. Distal Housing The blood sac 629 is fixed to a pump housing 62h including a proximal end stalk 630 and a pump housing 62h including a proximal end stalk 631. Generally, the flexure characteristics of the blood sac 629 and the pump housing 62h are significantly different. To achieve a long-term blood sac design, it is necessary to mount an intermediate suspension so that the pump assembly is continuous in the transition of structural characteristics (especially the bending deformation of the membrane). A pair of flexible stems (proximal end stem 630 and Distal stem 640) is used as a suspension mechanism that integrates the blood sac 629 and the pump housing 62h. As shown in FIG. 23A, the disk-shaped proximal end stem 630 is connected to the proximal end housing 623 and is connected to the ring-shaped Distal stem 640 is Distal Housing 625. Mechanically, the proximal and Distal stem 630, 640 not only retain the blood sac 629 within the pump housing 62h, but also act as a stress relieving suspension mechanism to avoid stress concentrations at the interface attachment points and increase the life of the blood sac 629.

[0085] As shown in the lower part of FIG. 23A, Distal Housing 625 includes an extension of an inlet connector 6251, which is coupled to the aortic connector 14. The inlet connector 6251 has a first end 6252 attached to the blood sac 629 and a second end 6253 shaped like a beak. Interface Adapter 501 (shown in FIGS. 18A and 18B). A first end 6252 of the inlet connector 6251 is connected to the blood sac 629. Distal end However, the opposing second end 6253 is Interface Adapter 501, and the coupling design goal is to avoid the formation of agglomerates. interfaceThe beak has a flange structure disposed in a mid-region of the inlet connector 6251 and is adapted to minimize discontinuities in the interface. adapter It functions as a locking part that receives 501.

[0086] During surgery, the closed end pouch design of the valveless blood pump 62 draws air into the pouch apex by buoyancy and collects air bubbles. See Figures 22 and 24. The proximal end casing 623 is fitted with or provided with an exhaust port 66, and a narrow passageway 661 is provided above the integral pouch pedicle septum 6301 between the proximal end stalk 630 and the blood pouch 629. In some embodiments, the passageway 661 extends along the centerline 62C. After matching the blood pump 62 to the target artery 60, the trapped air emerges under the pressure of arterial blood pressure and collects in the apex space of the blood pouch 629. A thin needle passes through the exhaust port 66, the passageway 661, the pouch pedicle septum 6301, and reaches the inside of the blood pouch 629 to expel the accumulated air. Because the entire capsule stalk 6301 below the exhaust port 66 is relatively rigid and not bent, the capsule 629 holding the perforation does not suffer further structural destruction, and structural destruction due to the propagation of cracks in the gaps of the perforation can be avoided when subjected to periodic pulse pressure or the expansion and contraction and folding of adjacent capsules.

[0087] As shown in Figures 23A and 25A, the pressure sensing mechanism 627 is embedded in the proximal end housing 623. Figure 23A shows a cross-sectional detail of the integrated proximal end housing 623, introducer 63, and drive catheter 67. Figure 25A shows the profile of the proximal end housing 623 that couples the introducer 63 extending from the dome of the proximal end housing 623 to communicate air and signals to the drive catheter 67.

[0088] As shown in FIG. 25A and FIG. 25B, the pressure-sensing mechanism 627 is hermetically housed in a metal can. Sensors 6271, a first space 6272 for fluid communication, and a micro-electromechanical system (MEMS) pressure Sensorsand a second space 6273 for housing the associated electronic circuitry. A plurality of electrodes 6274 extend from the bottom of the second space 6273 and are connected to the wires 6702 of the carrier 67 (FIG. 26). The second space 6273 is closer to the actuation catheter 67 than the first space 6272. The first space 6272 is open to communication with the sensing medium fluid. A biocompatible fluid or jelly is used as the pressure transmission medium. A chamber or pressure sensing chamber 628 located within the proximal end housing 623 and adjacent to the first space 6272 is shaped to confine the sensing fluid. The pressure sensing chamber 628 has a pressure sensing chamber 628a and a pressure sensing chamber 628b. Distal end is isolated from the blood cavity by a membrane sac 629. The pressure sensing chamber 628 has two side arms, a first arm 6281 for mounting the sensor 6271 and a second arm 6282 for filling and sealing the medium to be sensed. Thus, blood pressure pulses can be transmitted through the membrane blood sac 629 and hydraulically communicate with the remote MEMS sensor 6271 located in the second space 6273.

[0089] One embodiment of the present invention is a method for controlling a blood pump based on pressure. Sensors Innovation in design. Micro MEMS pressure Sensors In principle, due to its inherent microscale structure, MEMS Sensors The grains are very durable. Sensors The durability of the pressure sensing mechanism 627 depends on the packaging design. This pressure sensing mechanism 627 is non-blood contacting and isolated from the corrosive biochemistry associated with blood, providing the long-term signal collection and transmission necessary for long-term implantable assistive devices.

[0090] The carrier material 67 functions as a transmitter that converts electrical signals and transmits air pulse pressure between the blood pump 62 and the driving unit 98. Figure 26 shows a representative multi-layer carrier material 67 of the present invention. In this embodiment, the carrier material 67 includes an air lumen (or inner air tube) 6701, a plurality of electric wires 6702, a middle air tube 673, a coil (e.g., a metal coil) 674, an outer layer tube 675, a tether 676, siliconeIt has a sheath 677 , a rigid drive connector 678 and a protective hollow connector 679 .

[0091] The central part of the carrier 67 houses an air lumen 6701 (or air passage, called inner tube) with a lumen diameter of 2-5 mm, which can choose between low power consumption and low operation convenience. The electric wire 6702 for signal transmission is embedded in the wall of the carrier 67. Other carrier variant designs can be adopted. In addition to the design of the multi-layer carrier 67 shown in FIG. 26, the carrier 67 may be multiple cavities, for example, as shown in FIG. 27, so that the electric wire 6702 can be embedded in several small tube chambers and pulse air can flow to the larger tube chamber 6701. One of the small lumens can be attached with a tether 676 to limit the elongation of the delivery 67 and protect the electric wire 6702 from damage by external pulling force.

[0092] The inner tube or air lumen 6701 is received in an air tube 673 with a reinforcement sandwiched between them. Between the inner tube 6701 and the air tube 673, a coil 674 (or woven thread or net) can be reflowed to reinforce the wall of the carrier material, making the carrier material 67 flexible but kinking resistant. An outer layer tube 675 covers the inner and middle air lumen 6701 and air tube 673, and a helically wound wire 6702 can be used as a protective cover. Note that in some embodiments, the outer tube 675 and the carrier material 67 can be used as a protective cover. silicone A non-expandable tether 676 may be provided between the cover 677 to provide additional tensile strength required during externalization of the carrier 67. Clinically, the silica gel jacket 677 has been shown to be the least irritating to subcutaneous tissue and has the lowest transit infection rate.

[0093] In this embodiment, an air lumen 6701, a metal coil 674, an air tube 673, a spiral electric wire 6702, an outer layer tube 675, a tether 676, siliconeA sheath 677 is packaged in the body of the carrier 67. The proximal end 671 of the carrier 67 is inserted into a socket provided in the actuator 98. The rigid actuator connector 678 of the carrier 67 is adapted to be received in a socket in the actuator 98. The rigid actuator connector 678 is mounted flush with a plurality of electrodes 6781 (e.g., four electrodes 6781 of FIG. 23) to which wires 6702 are soldered. A protective hollow connector 679 (see FIG. 23(b), FIG. 26) is disposed at the junction of the actuator catheter 67 and the actuator connector 678 to prevent the carrier 67 from kinking at the junction. The proximal end 671 of the carrier 67 includes the actuator connector 678 and the hollow connector 679 and is mounted to allow easy exit from the skin without causing unintended puncture injury.

[0094] As shown in Figures 22 and 23A, the connection between the carrier material 67 and the blood pump 62 is achieved by an introducer material 63. Depending on the anatomy in which the blood pump 62 is to be implanted, the introducer material 63 may be located within the proximal housing 623 or Distal Housing 625. By integrating the introduction member 63 with the pump housing 62h, the arrangement of the entire external blood pump can be changed to guide the transport member 67 in a specific direction, such as the externalization path of the transport member, postoperative skin care, and facility availability.

[0095] As shown in FIGS. 23A and 25A, the inlet 63 is Proximal end The housing 623 has a first portion 631 which is an extension of the housing 623 and which is connected to the air passage of the driving catheter 67. Chamber 6701, the tether 676 and the wire 6702 are anchors. adapter The introduction member 63 is connected to the first portion 631 via a second portion 632. The introduction member 63 further has a second portion 632 which is linked to the first portion 631 as a hollow connector of the transport member 67. The first portion 631 is used for connecting electric wires, anchoring a tether, and air ChamberThe first part 631 is the location where the interface components are bonded to the housing and sealed. The wires must not be exposed to the tissue at the implant site and must be protected from tension during the externalization of the power transmission member. Also, the connection between the air lumen 6701 and the blood pump 62 must be air-free and current-free. The above blood pump integration tasks are performed in the first part 631. The second part 632 houses these interface components and acts as an external protector, protecting the interface from mechanical stresses and environmental fluids and moisture.

[0096] 19-27 show a modular design for a first embodiment of the blood pump of the present invention. In this embodiment, the blood pump 62 is comprised of an axisymmetric elliptical blood sac and stalk assembly 650 (flexible membrane sac 629, proximal stalk 630 and Distal stem 640), a proximal end housing 623 and Distal Housing 625, and a delivery member 67 is connected to the blood pump 62, the delivery member 67 including an air lumen 6701 and an electrical wire 6702 within its wall. An introducer 63 is used to provide electrical and pneumatic communication between the delivery member 67 and the blood pump 62 to integrate the drive catheter 67 with the pump housing 62h.

[0097] As shown in Figures 19 and 20, the design of the blood sac 629 and the stem 630, 640 connection has been disclosed in previous sections. The key to the design and manufacture is to maintain precise axial symmetry in the part manufacture and joining of the sac and stem assembly. The pressure sensitive mechanism 627 and the lead-in member 63 are mounted in a rigid portion of the proximal housing 623. Figures 22, 23A and 23B show the design of the lead-in member 63 in compaction. It can be seen that the compressed inlet 63 allows for a stronger and more fault tolerant wire and connection.

[0098] Figures 28A and 28B show some flow patterns associated with aortic balloon counterpulsation. During the late diastole and early systole of left ventricular bleeding, the blood pump draws aortic blood flow into the pump through pump filling (Figure 28A). The blood upstream and downstream around the connector becomes drawn into the blood pump with a sudden 90-degree flow. This causes flow separation and a low-velocity recirculation region T-201. Also, very high shear appears in the corner region of the T-joint. Meanwhile, during the diastole after the aortic valve closes, the blood stored in the pump is blown back into circulation, causing a shock flow on the opposite aortic wall (Figure 28B). This roll, impinging flow has a very high local pressure at the impinging point T-202, the so-called stagnation point, in which the flow velocity is practically zero and all the kinetic energy associated with the flow velocity is converted into potential energy, called the total pressure. Such high-pressure impinging flow may cause vascular maladaptation, such as smooth muscle cell proliferation and the resulting vascular wall stenosis, and the risk of aortic detachment due to persistent local hypertension. These non-physiological flow patterns and the induced high pressure, high shear, and low velocity recirculation phenomena are all ubiquitous near the T-tube. These turbulent, complex flow abnormalities are attenuated or diminished within a distance of 3-5 times the diameter of the implanted arterial lumen. The plug-in flow connector is designed with an insertion catheter length of 5-7 cm, covering most of the pump-induced non-physiological flow area. The aorta at the implant site is blocked by the inserted flow connector, so the native vessel wall is protected from the pathological stress conditions caused by the pump, and the artery at the implant site is protected from acute and long-term remodeling complications.

[0099] In anti-pulsatile support, the pump fills and ejects alternately in synchronization with the heart rate, resulting in a special T-joint flow as shown in Figures 28A and 28B. adapter 14 is further detailed in the perspective view of FIG. 29 and the cross-sectional view of FIG. 30, respectively.

[0100] Aorta adapter 14 is injection molded and its inner blood-contacting surface 141 is ultra-smooth, continuous, and free of parting lines. adapter 14 may comprise a silicone or other polymeric elastomeric material. adapter 14 comprises a polymer elastomer that includes a silicone resin material, or the polymer elastomer is moldinjectable polyurethane. adapter 14 is an aortic catheter for insertion into the aorta 95 (see FIG. 5 ). adapter The convex neck portion 143 includes a catheter (also called a catheter insertion portion) 142 and a neck portion (also called a protruding portion) 143 that is connected to a blood pump. In this embodiment, the convex neck portion 143 has a neck portion body 1431 and an extension portion 1432 provided on the neck portion body 1431, the extension portion 1432 protruding from the neck portion body 1431, and the maximum inner diameter of the extension portion 1432 is larger than the maximum inner diameter of the neck portion body 1431. When the convex neck portion 143 is connected to the blood pump 62, the extension portion 1432 forms an inlet of the blood pump 62. adapter 6251, and the neck body 1431 is surrounded by the coupler 25. adapter 6251 is integrally connected to the blood pump 62.

[0101] Aorta adapter The aortic stent 14 is thin-walled to maximize flow efficiency. To reinforce its thin-walled structure, a pair of nickel-titanium alloy metal stents (truss rings) 144 are inserted into the aorta. adapter 14 aorta adapter It fits over and surrounds both ends of the catheter 142 .

[0102] 29 is a schematic diagram showing the position where a metal stent 144 made of nickel-titanium alloy is embedded. adapterThe wall thickness of the catheter 142 is gradually tapered toward both catheter ends 145. The gradually tapered wall thickness serves two purposes. First, it minimizes discontinuity in the graft 502 / subject connection, making the rate of interface clot formation much lower than the rate of thrombolysis provided by contact with the endothelium. Second, the catheter becomes less compliant toward the catheter ends 145, creating a compliance matching effect upon connection with the aortic lumen.

[0103] One of the complications that is troubling in the delivery of large stent-grafts 502 is the endoleak problem. Type I endoleak is when the seal between the end of the implant and the implanted arterial endothelial lumen is incomplete, resulting in a gap between the leading edge of the implant and the arterial lumen. The oozing blood becomes trapped in the gap and coagulates into a blood clot, and eventually becomes a fibrous pseudointima that grows uncontrolled over time. The pseudointima not only occludes the implanted artery, but also signals and stimulates the clotting mechanism to attract platelet adhesion, which may lead to thrombotic failure. The solution to such endoleak problems is to use a large aortic wall as a stent wall. adapter The goal of the present disclosure is to provide a tight seal between the aortic graft 14 and the luminal surface to which it is attached. adapter 14 proposes a compliant design concept that allows the semi-rigid catheter (terminal) end 145 to seamlessly fit into the arterial lumen when subjected to pulsatile pressure. As shown in FIG. adapter The outer diameter 146 of the catheter 142 is slightly larger than the diameter of the inner lumen, and the oversize ratio (defined as the ratio of catheter diameter to inner lumen diameter) is within the range of 3-10% for a given nominal blood pressure (e.g., 120 mmHg). The compliant catheter distal section 145 dynamically expands and contracts without boundary clearance in response to pressure pulsations when blood pressure fluctuates between systole and diastole, or under pulsatile pressure with counterpulsatile support.

[0104] Thin-walled elastomeric tubes are often flexible and compliant, but are not strong enough to withstand the compressive forces exerted by the bulk of the device and may cause the tube to collapse during insertion. adapterThe wall of the aorta is often bent. Therefore, it is important to combine a structure using a nickel-titanium alloy metal stent 144 with an elastomer substrate having a suitable hardness. As shown in FIG. 30, in this design, the nickel-titanium alloy metal stent 144 ensures radial rigidity, so that the aorta wall can be easily bent. adapter 14 can be supported without bending, and there is a distance "x" between the outermost boundary 1441 of the metal stent 144 and the catheter end 145. In some embodiments, the distance x needs to be evaluated and precisely defined. By supporting the nickel-titanium alloy metal stent 144 as an expandable frame, the gradually thinning catheter end 145 abuts the connected lumen wall and dynamically seals with the lumen, keeping it round without collapsing or wrinkling. Note that the aorta adapter 14 is able to expand and contract in response to pressure pulsations and can penetrate the aorta without bleeding complications. adapter 14 and the wall of the aorta 95 expand and contract together, dynamically creating a sealing effect around the catheter end 145.

[0105] FIG. 31 shows a representative embodiment of a nickel-titanium alloy stent 144, typically made of a laser-sculpted nickel-titanium alloy, which is further expanded by a series of expansion and heat treatments. FIG. 31 shows a flat development of the metal stent 144. (One row at a time) The metal stent has a multi-corrugated structure. The metal stent 144 is self-expandable, and can be folded or curled into small curls, placed in a pre-crushed roll, and self-released to return to its original shape after being placed in the required position.

[0106] A simple measurement of catheter stiffness (the inverse of compliance) can be expressed as the so-called lateral stiffness (LS), and its measurement method is illustrated in Figure 32. The lateral stiffness is defined as the applied force F per unit length divided by the corresponding radial deflection Y. adapterIn this study, the appropriate lateral stiffness range is 0.01-0.05 Nt / mm2. silicone Resin or elastomer substrate is co-injected into the aorta adapter The structural compliance of the metal stent 144 and the aorta adapter The structural compliance of the 14 polymer elastomers is approximately equal. The tendency for layering between layers to be minimized by the expansion and contraction of the composite catheter wall. adapter It is preferable for the softness to be evenly distributed so that the life of the 14 is increased.

[0107] Aorta adapter 14 is arranged to be connected to a blood pump 62 to facilitate circulatory support. Here, a quick connector type coupler 25 is provided. As shown in FIG. 33, the aorta adapter 34A shows an exploded schematic view of each part of a coupler 25 integrating a diaphragm 14 and a blood pump 62. The coupler 25 includes a flange base 252, a pair of locking rings 253, and a hinge (or hinge assembly) 254 connecting the locking ring 253 and the flange base 252. A spring coil (or coil assembly) 255 is loaded into a hinge joint 256 to hold the locking ring 253 in an open position when the coupler 25 is unlocked (FIG. 34A). The locking mechanism relies on a leaf spring latch 257, which is made of a grooved spring piece and is fixed via a plate 2571 welded to one end of the locking ring 253. The flange base 252 has a substantially circular structure, and each locking ring 253 has a circular arc structure. The hinge joint 256 is located on a first side 252S1 of the flange base 252, and the leaf spring latch 257 is located on a second side 252S2 of the flange base 252 opposite the first side 252S1. The lock ring 253 is pivotally attached to the hinge joint 256 and is rotatable relative to the hinge joint 256 and the flange base 252. In some embodiments, the coupler 25 and the aorta adapter 14 is the aorta adapter Belongs to part of an assembly.

[0108] Figure 34b shows a schematic diagram of coupler 25 in a locked state, with the slot of leaf spring latch 257 firmly engaging with ramp 258 to ensure a secure connection without risk of separation. adapter The integral connection between the blood pump 62 and the blood pump 14 is made by a deformable adapter A rigid flange base 252 and a blood pump inlet 254 are connected to each other via a proximal end 147 (FIG. 30, i.e., the end of the neck portion). adapter It functions as a "gasket" between the 6251 and the rigid beak-shaped flange 81 (described below).

[0109] Specifically, as shown in FIG. 34(b) and FIG. 35, the closed locking ring 253 can easily perform quick-connect locking without worrying about accidental unlocking. The plate spring latch 257 is attached to the end of one of the locking rings 253. While the locking ring is locked, the plate spring latch 257 bends as it slides over the (convex) slope 258 of the opposite locking ring 253 during locking. When the plate spring latch 257 overcomes the top of the slope 258, it lowers to the bottom of the slope 258 by elastic restoring force, which acts as insurance against accidental unlatching and opening of the locking ring due to pump vibration or long-term rocking. In case of pump explant or replacement requiring module separation, the plate spring latch 257 is bent and lifted upward by the tool used, and an unlocking force is applied to rotate the locking ring 253 open, thereby connecting the blood pump 62 to the aorta. adapter It can be removed from 14.

[0110] The butt joint design does not allow for two smooth surfaces to be connected in the bloodstream. In many clinical applications, the surface of the connected graft 502 is rough, promoting endothelialization, whereby small boundary discontinuities in the bloodstream are "smoothed out" by ingrowing cells and proteins. adapter 14 avoids the occurrence of poor thrombosis by making the surface smooth, but the reason for this has already been explained. As shown in Figures 28A and 28B, adapterThe jetting and filling action of the blood flow in response to the counter-pulsating pump is bidirectional. Due to this strong bidirectional flow and surface cleaning effect, any newly formed blood clots on the rough surface can be easily removed. Therefore, the smooth surface design is considered to be more compatible with the present invention and safer to use. The interface of two connected smooth surfaces in the blood flow requires careful mechanical and hemodynamic design to prevent the in situ occurrence of thrombus events. The following discloses the principles and design methods related to the invention of such a new fitting.

[0111] Figures 36A and 36B respectively show the two basic boundary discontinuities that exist in butt joint connections, e.g. adapter AB1 (e.g., blood pump 62 adapter )and adapter AB2 (e.g. aorta adapter 14), resulting in a step 101, 102, or gap 103. Figures 36A and 36B are exaggerated illustrations; typically, with precision machining, such joint discontinuities are within 10-50 microns, which is large enough to cause clots and thrombus formation.

[0112] In reality, two separate objects need to be toleranced even though the machining of each object is exactly the same. Figure 36A depicts two misaligned joints where everything about the part manufacturing is completed correctly except for the centerlines not being aligned. A step facing forward and a step facing backward 101, 102 are created, and stagnant flow in the step areas 101, 102 is the origin of clots or thromboemboli. As shown in Figure 36B, the non-parallel matching of the joints creates a boundary gap 103. The gap 103 attracts and collects blood cells, which further grow into a pseudointima. This intimal growth is often uncontrollable and can result in a thrombus bolus that is shed from the intimal surface as well as blocking the entire blood flow path. The incorrect boundary of the butt joint can be exacerbated if the connected objects are non-rigid. Aorta of the present disclosure adapter 14 is semi-rigid and is connected to the fitting by a forced press fit (e.g., an inlet adapter) with a deformed structure and enlarged boundary discontinuities. Therefore, the current semi-rigid aorta adapter In order to realize the connection between the blood pump and the blood vessel, it is necessary to invent a new connection means as follows.

[0113] 37 and 38. In some embodiments, the blood pump 62 has an inlet connector 80 that includes a beak flange 81, a beak 82, and a connector body 83 as an extension of the housing of the blood pump 62. The connector body 83 includes a number of holes 86 for connecting the inlet connector 80 to the blood pump 62.

[0114] The inside diameter 84 of the beak 82 is the aorta adapter 14 (see FIG. 30). adapter 30 and 35, the contact area with the proximal end (end) 147 of the inlet connector 80 is an annular tapered surface (also called a shallow inclined surface or inclined surface) 149, so that the beak portion 82 can be said to be a tapered beak. The shallow inclined surface 149 is inclined with respect to the center line of the catheter insertion portion, and the taper angle of the shallow inclined surface is within the range of 30-60 degrees measured from the rotation center line of the inlet connector 80. In the initial locking engagement, the lock ring 253 having an inner groove 2531 on the inside is loosely caught by the flange of the flange base 252 and the flange of the beak-shaped flange 81. As the lock ring 253 is locked, the beak-shaped flange 81 (inlet connector 80) and the flange base 252 (coupling 25) are accommodated in the inner groove 2531 of the lock ring 253 and pressed, so that the intermediate silicone Rubber end 147 (aorta adapter 14) is compressed and clamped to generate a clamping force that firmly connects the inlet connector 80 of the blood pump 62 to the aorta. adapter 14 and is firmly connected.

[0115] The above-described clamping force generating mechanism is shown in FIG. 35. The flange base 252 has two steps 2521 and 2522 for generating a clamping force. Before the lock ring 253 closes, the step 2521 should first be engaged with the locking groove 1433 (see FIG. 30) of the convex neck portion 143 of the aorta adapter 14. This engagement is achieved by first bending and twisting the convex neck portion 143 and then inserting the deformed convex neck portion 143 through the flange base 252. Due to the elastic restoring force of the aorta adapter 14, the bent convex neck portion 143 returns to its original circular (or shape), allowing the step 2521 to engage with the engagement groove 1433. The height Z of the internal groove 2531 of the lock ring 253 controls the adapter pressing deformation of the proximal end 147 of the convex neck portion 143. Referring to FIG. 35. In this locked configuration when the lock ring 253 closes and locks, the gap Z0 (i.e., the thickness Z0 of the pressed adapter proximal end 147) is smaller than the thickness Z3 of the end portion 147 of the aorta adapter 14 (see FIG. 30), that is, it can be seen that the thickness Z0 of the pressed adapter proximal end 147 is smaller than the thick Z3 of the starting end 147 (Z0 < Z3). For the thickness Z0 of the pressed adapter proximal end 147, the following formula can be obtained from FIG. 35.

[0116] Z0 = Z - Z1 - Z2 … Formula (1)

[0117] In Formula (1), Z1 and Z2 are the thicknesses for clamping the mating beak-shaped flange 81 and the step 2522 of the flange base 252, which are mating parts, respectively, as shown in FIG. 35. Usually, since the thickness Z3 is larger than the gap Z0, the distorted adapter proximal end 147 of the aorta generates the clamping force required to seal-connect the beak-shaped flange 81 and the annular flange base 252. adapter The distortion of the proximal end 147 is defined as [Z3 - Z0] / Z3 and is within the range of 10 - 30%, which is sufficient to ensure a reliable sealed connection.

[0118] FIG. 39 shows the aforementioned beak portion 82 and adapter 1 illustrates the mating characteristics of the current connection with the semi-rigid tapered surface 149 of the aorta. When connected, the beak 82 and its beak leading edge 85 sink into the semi-rigid tapered surface 149, providing a natural connection to the aorta. adapter 14 has a depth corresponding to the leading edge radius of the beak leading edge 85, typically 30-50 microns. In FIG. 39, the dotted line and bracketed numbers indicate the initial contact between the beak 82 and the beak leading edge 85, while the solid line and open bracketed numbers indicate the locked position. Note that the boundary discontinuity is reduced by the recession of the shallow slopes 149, 82 from their original shape (dashed lines) as previously mentioned. The thickness of the internal groove 2531 controls the tight fit of the bond between the two. As previously mentioned, the elastic aorta adapter The proximal end 147 of is compressed to approximately 10-30% strain to provide the necessary cohesive strength to resist pulsatile pumping.

[0119] Blood pump 62 and aorta adapter Between 14 and interface The current design of the connection has two hemodynamic advantages that reduce insitu thrombus formation. First, it has been observed that the conventional docking connection does not actually result in a step or gap type joint discontinuity. Second, it minimizes stagnation flow at the boundary of the beak leading edge 85. Thus, the connection interface The blood flow through the endothelium is increased, and the docking connection defect is significantly improved. interface The front or rear steps 101, 102 or gaps 103 occurring in the above-mentioned manner are significantly improved.

[0120] The shallow taper slope 149 of this embodiment is inclined at an inclination angle with respect to the flow direction. interface The design of avoids the step and gap in the joint caused by the limited manufacturing accuracy and matching eccentricity associated with conventional docking connections. However, this tapered shallow slope 149 has an inherent deficiency in achieving concentric centerline alignment of mating counterparts. Aorta adapterThe connection between the flange 14 and the beak 82 does not have a strict lateral constraint to ensure interlocking alignment. It is important to simultaneously hook the locking ring around the entire periphery of the flange base 252 to achieve a concentric connection between the rigid beak 82 and the semi-rigid shallow bevel 149. If the simultaneous locking / locking engagement is not completed, the shallow bevel 149 that is first engaged will tend to distort and tilt more than the other free portions, or position the remaining contact surface, resulting in an eccentric connection to the pump. Such an eccentric connection is usually the cause of a step or gap at the interface, which can lead to thrombus formation. This shortcoming is compensated for by arranging the locking ring contour 259 (FIG. 34A) on the distal (lower) side of the locking ring 253 to include all circumferential contact areas simultaneously with the locking engagement. When locked, the contact edge of the metal (in some embodiments) beak 82 sinks slightly into the shallow bevel 149 of the controlled depth compressed silicone material (in some embodiments), further reducing boundary discontinuity upon exposure to blood flow. Moderate administration of anticoagulant can significantly reduce or eliminate normal boundary thrombosis.

[0121] This aorta adapter The deformability of the structure and delivery method involved in 14 provide a special design feature of the present invention. Indeed, material flexibility considerations must be carefully incorporated into the present design. In terms of intraoperative safety and long-term reliability, it is difficult to deliver the intercalable graft 502 into the aorta during open aortic wall surgery. Therefore, in some embodiments, the intercalable graft 502 is inserted into the aorta. adapter The material selected by 14 should have a predetermined memory shape. adapter 14 is first crimped into a small indwelling mold (as shown in Figure 40). adapter 14) This indwelling type ensures quick and safe implantation of the device. adapter After being placed at the desired implant site, the indwelling aortic catheter 14 is adapter 14 should be released and self-expand to its original memory shape.

[0122] Aorta adapterA hole 12-14 mm in diameter should be formed in the aortic wall prior to insertion of the 14. Care should be taken in creating such an access hole to avoid creating edges that may serve as the initiation point for cracks, as the wall must be expanded as the device is inserted. A side-biting aortic perforator, such as that disclosed in U.S. Patent Application No. 17 / 034036, is an ideal tool for creating a large hole in the aorta. A light tap can be used to create an unbroken hole.

[0123] Aorta adapter 14 is morphologically comprised of two circular tubes connected to form a T-shaped flow connector for performing para-aortic circulation support. The thickness of the catheter wall is usually 1-2 mm, and the material used is a polymer with appropriate hardness, such as silicone resin or urethane, with a hardness of Shore A80-90. The structure of the curl-in is significantly different from the large stent graft 502 covered with commercially available duck nylon or PTFE (polytetrafluoroethylene) fabric. Figure 40 shows the aortic adapter 14 shows the curl / embedded configuration. (Metal stent 144 made of nickel-titanium alloy is implanted in the aorta with polymer matrix.) adapter 14) Aorta adapter 14 shows that the collapsed catheter is in the aorta as shown in FIG. adapter The catheter 142 is inserted into a portion of the catheter 142, whereby the T-shaped convex neck portion 143 is crushed and flattened, and the folded adapter 14. The aorta is bent and sunk into the main body. adapter The diameter of 14 is approximately half the diameter of the original unfolded circle.

[0124] It is folded like this adapter The catheter 14 can be fixed by tensioning a rope. As shown in Figure 40, three fixing strings can be placed at both edges and the center of the catheter, but other fixing methods are also possible. Figures 41A, 41B, 41C, and 41D show the aorta in the indwelling form. adapterFour representative stages of the procedure are shown. The first stage (see FIG. 41A) is the alignment of the preroll sac (the aorta) with respect to the axis of the aorta 95. adapter 14) is tilted at an angle, the initial transmission image shows the passage of the aorta through the access hole in the form of a curled prerolled sac. The second stage (Figure 41B) shows the aorta in its fully inserted form. adapter FIG. 41C shows the aorta with the preroll sac 14 entering the aorta, with the preroll sac passing through the access hole and one end rotating and dropping into the access hole. The fully inserted preroll sac is then repositioned so that the curled neck portion 143 is aligned with the access hole. The restraining ties are released, and the aorta with the curled sac in its deployed form is then repositioned. adapter 14 is allowed to elastically expand and return to its original shape (FIG. 41D). adapter 14 is tightly surrounded by the aortic cavity, which is ensured by the appropriate oversize ratio selected before insertion. The T-shaped convex neck portion 143 can be slightly deformed and the flange base 252 (FIGS. 33-34B) of the coupler 25 can be attached to the T-shaped convex neck portion 143 in preparation for connecting the blood pump 62. For this reason, the blood pump connection can be easily realized by setting the inlet beak 82 on the tapered shallow slope 149 and then closing the two locking rings 253 of the coupler 25 to achieve a strong device connection.

[0125] Additional safety measures can be applied to enhance hemostasis and stability of the implanted para-aortic blood pump system. Due to the weight of the blood pump 62 and the pumping force due to counter-pulse support, the placement of the blood pump near the aorta necessarily creates lateral forces (perpendicular to the longitudinal direction of the aorta) and aortic wall pressure. adapter The force associated with this device may affect the long-term remodeling of the vasculature at the implant site. Purse-string sutures can be placed in the adventitial layer around the hole. The band sutures are inserted to adapter 14, which can tighten the aortic wall extra tightly and is used as a protective measure to prevent the access hole from expanding. adapterThe catheter 142 can be wound around both ends and tensioned, and the catheter can be inserted into the aorta. adapter 14 and the aorta are strengthened. Proper design and tightening of the annular tape can provide a double endoleak prevention. In some cases, blood pressure can exceed the upper limit of compliance matching without endoleak. In such extreme situations, the surgical tape begins to function and acts as a hard limiter, trying to separate. adapter Seal the end of the catheter and ensure hemostasis.

[0126] As shown in FIG. 42, in some embodiments, the aorta adapter The step-by-step installation of the implant 14 is described in detail here. Before starting the implantation, the aortic adapter After exposing the target thoracic artery through a left thoracotomy, a cross clamp distance of approximately 10 cm spanning the implant site is determined. The access hole to be made in the aorta is first marked with a peri-hole marker. The sutures of the band are then sutured to the outside of the hole's periphery in the adventitial layer. The aorta can then be partially separated from the surrounding connective tissue, and a pair of surgical tapes can be wrapped around the aorta. After the above preparations are complete, the cross clamp and aorta are adapter These insertion steps are described in the procedure shown in Figure 17. First, the aorta is crossed and clamped to provide an isolated segment without bleeding problems. Then, a customized aortic perforator is used to cut the aorta. adapter Next, a large access hole is created for inserting the 14. Then, as shown in Figures 41A, 41B, and 41C, the folded adapter The pre-rolled sac is then inserted and placed across the aortic segment, as shown in FIG. 41D. adapter 14 is released and returned to its original deployed configuration. It is then tightened with ties and tape as additional protection against hypertensive endoleaks. Then coupler 25 is attached and its step 2521 is inserted into the aorta. adapter14 into the locking groove 1433 of the convex neck portion 143 of the coupler 25, thereby preparing to receive the blood pump 62 to be connected. Due to the self-alignment ability of the coupler 25 described above, the inlet connector 80 of the blood pump 62 can be accurately positioned to be connected to the aorta. adapter The remainder of the implantation procedure is routine, including cross-clip release, blood pump evacuation and pump start assistance. Generally, for an experienced surgeon, the aortic adapter The cross-clamp time required to insert the catheter is approximately 10 minutes. During this cross-clamp period, the abdominal organs are deprived of blood perfusion, which may cause ischemic damage. To reduce potential surgical damage to such organs, femoral-femoral ECMO (femoral extra-corporeal membrane oxygenation) support can be used to perfuse the abdominal organs and lower limbs. However, it is the surgeon's decision whether to adopt ECMO support. Usually, a normal patient can tolerate an ischemic time of 20 minutes.

[0127] As described above, in accordance with an embodiment of the present invention, there is provided a ventricular assist device comprising a blood pump, a carrier and an introducer. The blood pump includes an axisymmetric elliptical blood sac and stalk assembly, which includes a flexible blood sac, a proximal stalk, Distal stem wherein the flexible blood sac is connected to a proximal end stalk and Distal stem The blood pump is connected to a suspension mechanism for stress relief. Proximal End Housing and Distal Housing and a pump housing including a suspension mechanism connected to the pump housing for stress relief. The blood pump further includes a pressure sensing system fitted to the proximal housing, the pressure sensing system including a blood pump pressure sensor and a pressure sensing chamber filled with an incompressible fluid for pressure transmission. The carrier includes an air lumen and at least one electric wire and tether included in a wall of the carrier, the electric wire and tether being disposed in the wall of the carrier. The inlet connects the delivery to the pump housing.

[0128] An embodiment of the present invention discloses a pulsating blood pump design that combines the concept of a non-stationary fold line with the structure of a long-term blood sac, which can substantially extend the durability of a displacement blood pump. Also provided is a micro pressure-sensing system that can be used as a reference waveform for real-time pump control and long-term trend analysis based on real-time big data, and disease monitoring and diagnosis based on real-time big data. In addition, the implantable pressure-sensing system does not contact blood, so the reliability requirements for building an implantable sensor system are greatly increased.

[0129] Embodiments of the present invention have at least any of the following advantages or effects: The inlet of the delivery and pump housing is connected to provide a compact inlet design for more robust and fault-tolerant cord and signal transmission; and the post-pressure introduction design integrates the induction wire, air tube, and blood pump. This compactness attribute is particularly important for implantable devices; it not only simplifies the surgical procedure and reduces the risk of perioperative implantation, but also helps reduce postoperative morbidity associated with delivery infection.

[0130] In some embodiments, the introduction agent is a Distal Housing The materials introduced are Distal Housing The first portion is an extension of the power transmission member. Chamber The second part is connected to the first part, which acts as a hollow connector for the carrier to achieve the advantages of anatomical adaptability and adaptability to the various shapes of the implant site.

[0131] Therefore, an object of the present invention is to provide an aortic catheter in which a ventricular assist device can be implanted, the aortic catheter including a catheter insertion section and a convex neck section, the catheter insertion section and the convex neck section being connected to each other and both having smooth surfaces that come into contact with blood, and a metal stent provided in the catheter insertion section. adapterThe present invention provides a flow connector assembly, comprising a T-shaped flow connector having a polymeric elastomer reinforced by a metal stent having a nickel-titanium alloy material, a catheter insertion section having a gradually thinned wall at both catheter ends, the distal ends of the catheter ends being a suitable distance to the outermost boundaries of the metal stent, the catheter ends being compliantly matched to the artery at the implant site, and a proximal end of the convex neck portion being adapted to be connected to the inlet of a blood pump. adapter The device is arranged to be connected to the

[0132] The embodiments of the present invention have at least one of the following advantages or effects: The present invention discloses a flow connector assembly that allows blood flow to and from a para-aortic ventricular assist device, particularly a counter-pulsatile blood pump. Unlike conventional flow connectors that employ many existing surface roughening methods to promote endothelialization and avoid the occurrence of thrombosis events, the present exposed aortic adapter adopts the concept of smooth surface, insertable pseudograft 502 to construct the flow connector. It also has a flexible matching design around the end of the inserted catheter, combining the gradually thinning wall characteristics with a thin-walled polymer supported by a superelastic nickel-titanium alloy frame to achieve the requirement of no endoleakage. The abnormal high pressure, high shear and slow recirculation flow phenomena associated with aortic parapulsatile pumping are included in the artificial surface of the catheter insertion. Therefore, the hemodynamic effects and risk factors of pathological devices are almost eliminated, and the incidents of long-term vascular maladaptation such as endothelial cell erosion, lipid infiltration, smooth muscle cell proliferation, vascular stenosis and arterial wall detachment are obviously reduced. Semi-rigid flow adapter To achieve a good connection between the aorta and the blood pump, this exposure provided a quick-fit coupling. This coupler has a self-aligning interface design, which minimizes step and gap discontinuities and reduces the possibility of thrombotic failure at the interface junction. adapter In cooperation with the invention of the present invention, a specially designed deployment method can be provided to ensure a fast and safe deployment process. adapter The pre-rolled pouch was placed in a pre-rolled / retained configuration and its overall size was reduced to half of its original size. adapter It can be easily inserted into the aorta at the implant site, expand to initial placement on its own, and form an attached flow connector without the risk of endoleakage, which not only reduces the risk of implantation during surgery, but also helps to reduce postoperative morbidity associated with device flow and vascular maladaptation at the implant site.

[0133] Ordinal numbers, e.g., "first", "second", etc., in this specification and in the patent application have no sequential relationship to one another and are used only to indicate a distinction between two different components that have the same name.

[0134] The embodiments described herein are intended to provide a method and apparatus for the preparation of a method for producing a semiconductor device, the method comprising the steps of: (a) providing a method for producing a semiconductor device comprising the steps of: (a) providing a method for producing a semiconductor device; [Explanation of symbols]

[0135] 10, 20, 30, 40, 90 Paraaortic Blood Pump Device 11, 21, 31, 41 Battery supply system 12, 22, 32, 42, 52, 62, 92 Blood pump 14, 24, 34, 44, 54, 64, 94 Aorta adapter 16, 26, 36, 46 Drive Catheter 18, 28, 38, 48, 78, 98 Drive unit 25, 45, 65 Coupler (Coupling adapter ) 33, 43, 93 Drive Catheter Interconnector 37, 47, 57, 67, 97 Distal drive catheter 39, 49, 99 Proximal drive catheter 52h, 62h Rigid housing 523, 623 Proximal End Housing 525, 625 Distal Housing 526 Capsular membrane 529 Blood Sac B blood chamber A Air chamber 527 Pressure-sensitive mechanism 528 Pressure Sensing Chamber 530 Proximal Port 540 Distal Port 545, 645 Catheter end 101 stairs 102 stairs 103 Gap 141 Blood contact surfaces 142 Aorta adapter catheter 143 Convex neck 1431 Neck body 1432 Extension 1433 Card Slot 144 Metal Stents 1441 Outermost Boundary 145 Catheter End 146 Outer diameter 147 adapter Proximal end 148 Inner diameter 149 Shallow Slope 252 flange base 221 Stairs 222 Stairs 252S1 1st side 252S2 2nd side 253 Lock Ring 231 Internal groove 254 Hinge 255 Spring coil 256 Hinge Joint 257 Leaf Spring Latch 571 Plate 258 Slope 259 Lock Ring Contour 50 Connectors 501 adapter 502 Transplant 503 Connector 504 Distal end 63 Introduction materials 62A Inverted membrane 621 Groove 623 Proximal end housing 625 Distal Housing 6251 Inlet Connector 6252 1st end 6253 2nd end (23A)6254 627 Pressure-sensitive mechanism 6271 Sensor 6272) 1st space 6273 2nd space 6274 Electrode 628 Pressure Sensing Room 6281 First Arm 6282 Second Arm 629 Blood Sac 630 Proximal end pedicle 6301 Cystic septum 631 Part 1 632 Part 2 640 Distal stem 643 Neck 650 Stem Assembly 66 Exhaust port 661 Aisle 67 Transport materials 6701 Air Lumen 6702 Electric wire 671 Proximal end 672 Anka adapter 673 Air Tube 674 Coil 675 Outer tube 676 Tether 677 silicone sheath 678 Rigid Drive Connector 6781 Electrode 679 Hollow Connector 60 arteries 6291 Proximal end 6292 Distal end 6293 Three-petal type 6294 crease 62C center line 71 Battery hatch 73 User Interface panel 75 Drive Catheter Socket 77 External power socket 79 Vent 80 Inlet Connector 81 Beak-shaped flange 82 Beak 83 Connector body 84 Inner diameter 85 Beak front edge 86 holes 971, 991 Drive catheter internal body segment 973, 993 Drive catheter extracorporeal segment 95 Aorta 96 Drive Catheter EX exit part OP Opening 110 Electromechanical actuator 120 Motor Controller Unit 130 Microcontroller Unit 140 Power Management Unit 150 Battery Module 170 User Interface Module 190 Clinical Monitor T-201 Slow Recirculation Area T-202 Impact Point AB1 adapter AB2 adapter

Claims

1. A ventricular assist device incorporating a pressure sensor, comprising: an axially symmetrical elliptical blood sac and pedicle assembly including a flexible membrane sac, a proximal stalk and a distal stalk, the flexible blood sac being connected to the proximal stalk and the distal stalk to provide a stress relief suspension mechanism; a pump housing including a proximal housing and a distal housing, the pump housing having a stress relief suspension mechanism connected thereto; a pressure sensing system fitted to the proximal end housing and including a pressure sensor and a pressure sensing chamber filled with an incompressible fluid for pressure transmission; a carrier including an air lumen and at least one electrical wire and a tether contained in a wall of the carrier, the electrical wire and the tether being disposed in a wall of the carrier; and an introduction member connecting the conveying member and the pump housing. A ventricular assist device with a built-in pressure sensor.

2. A ventricular assist device incorporating the pressure sensor of claim 1, A ventricular assist device containing a pressure sensor having a vent outlet in said proximal end housing.

3. A ventricular assist device incorporating the pressure sensor according to claim 2, A ventricular assist device having a passageway communicating with an exhaust port, the passageway extending along a centerline of the axisymmetric elliptical blood sac and stalk assembly, and incorporating a pressure sensor located above the septum of the integrated blood sac and stalk assembly.

4. A ventricular assist device incorporating the pressure sensor of claim 1, The flexible blood sac has an inversion membrane located at a distal end of the flexible blood sac, and the distal stem is wrapped around and connected to the inversion membrane; The proximal stalk includes a pressure sensor located at the proximal end of the flexible blood sac.

5. A ventricular assist device incorporating the pressure sensor of claim 1, further comprising an arterial connector having an interface adapter; the distal housing having a distal housing adaptor for facilitating connection of the blood pump to a human artery; The housing adapter has a first end and a second end, the first end being connected to an inlet of the flexible blood sac and the second end being connected to the interface adapter for connection to a human artery.

6. 6. The pressure sensor incorporating ventricular assist device of claim 5, wherein the distal housing adaptor has a beak, the beak having a flange structure coupled to the interface adaptor.

7. 2. A ventricular assist device incorporating a pressure sensor according to claim 1, further comprising a drive unit, said carrier incorporating a pressure sensor connecting said blood pump to said drive unit.

8. 2. A ventricular assist device incorporating a pressure sensor as described in claim 1, wherein the pressure sensor is hermetically housed in a metal can, and the pressure sensor includes a first space for communicating a fluid therewith.

9. 9. A ventricular assist device incorporating a pressure sensor as described in claim 8, wherein the pressure sensor includes a second space closer to the carrier than the first space, the second space configured to accommodate a micro-electromechanical system (MEMS) pressure sensor and electronic circuitry.

10. 10. A ventricular assist device incorporating a pressure sensor as described in claim 9, wherein a pressure sensing chamber is located within the proximal end housing and adjacent to the first space, the pressure sensing chamber being adapted to have a sensing fluid trapped therein.

11. 11. A ventricular assist device incorporating a pressure sensor as described in claim 10, wherein the pressure sensing chamber has a first arm and a second arm, the first arm for mounting the pressure sensor and the second arm for filling and sealing with a sensing medium.

12. 2. The ventricular assist device incorporating a pressure sensor as claimed in claim 1, wherein the introducer is integral with the proximal housing; the introduction material has a first portion that is an extension of the proximal end housing, the air lumen, the carrier material tether, and the electrical wire are connected to the first portion; The delivery material has a second portion that interfaces with the first portion, the second portion incorporating a pressure sensor that functions as a buffer flexure for the delivery material.

13. A ventricular assist device incorporating the pressure sensor of claim 1, The carrier further includes an intermediate air tube and a coil, the air lumen being received in the intermediate air tube, and the coil incorporating a pressure sensor located between the air lumen and the intermediate air tube.

14. 14. A ventricular assist device incorporating the pressure sensor of claim 13, The carrier further comprises an outer layer tube, the air lumen and the intermediate air tube being housed within the outer layer tube, and the electrical wires being covered by the outer layer tube.

15. 15. A ventricular assist device incorporating a pressure sensor as claimed in claim 14, wherein said tether incorporates a pressure sensor mounted to said outer layer tube.

16. 8. The ventricular assist device incorporating a pressure sensor as claimed in claim 7, wherein the carrier further comprises a rigid drive connector located at a proximal end of the carrier; The carrier is connected to the drive unit, and the rigid drive unit connector is a ventricular assist device incorporating a pressure sensor connected to the drive unit.

17. 17. A ventricular assist device incorporating a pressure sensor as claimed in claim 16, wherein said rigid drive connector has a plurality of electrodes welded to said wires mounted flush thereon.

18. 2. A ventricular assist device incorporating a pressure sensor according to claim 1, wherein the introduction material is integrated with the distal housing, the introduction material has a first portion as an extension of the distal housing, and the first portion is connected to the air lumen, the tether, and the electric wire of the carrier material; The delivery material further includes a second portion coupled to the first portion, the second portion incorporating a pressure sensor that functions as a buffer flexure for the delivery material.

19. 20. A ventricular assist device incorporating a pressure sensor as described in claim 18, wherein the proximal housing and the distal housing have an overlapping joining area, and the pump housing has a surface groove formed above the overlapping joining area.

20. 20. A ventricular assist device incorporating a pressure sensor as claimed in claim 19, wherein said groove is sealed by a waterproof potting material.

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