WO2023284361A1 - System for treatment of heart failure - Google Patents

Abstract

A system for the treatment of heart failure, comprising a manipulation mechanism (1), a delivery catheter (2) connected to the manipulation mechanism (1), and an injection module (3) and a guiding and positioning device (5) which are arranged in the delivery catheter (2), wherein a distal portion of the injection module (3) is in a preset configuration, and the guiding and positioning device (5) is at least partially arranged in the delivery catheter (2); and when a distal end of the delivery catheter (2) reaches a target position, and the injection module (3) gradually and distally extends from the inside of the delivery catheter (2), the guiding and positioning device (5) can ensure that the distal portion of the injection module (3) can be restored to the preset configuration according to a predetermined route. The system for the treatment of heart failure can improve the injection efficiency and the effect of the injection.

Description

A heart failure treatment system

This application claims the priority of the Chinese invention patent application "a heart failure treatment system" with the application number 202111630646.4 filed in China on July 13, 2021, the entire content of which is incorporated by reference in this application.

technical field

The present application relates to the field of medical devices, in particular to a heart failure treatment system.

Background technique

At present, the morbidity and mortality of heart failure are relatively high, and it is an important cause of death for most patients with cardiovascular diseases. There are nearly 23 million people in the world suffering from this disease. The full name of heart failure is heart failure, which means that due to the dysfunction of the systolic or diastolic function of the heart, the venous return blood cannot be fully excreted from the body, resulting in blood stasis in the venous system and insufficient blood supply in the arterial system, which eventually leads to cardiac circulatory system disorders. It is estimated that the incidence of acute myocardial infarction in my country is about 45/100,000 to 55/100,000, and it is still showing an upward trend. Since the development of heart failure is relatively slow, most of it is due to the accumulation of various diseases of the patient for many years, the heart gradually loses the function of pumping blood, and the functions of all aspects gradually weaken, accompanied by heart enlargement, mainly left ventricular enlargement. The quality of life and clinical treatment have a great negative impact. Existing treatment options include drug therapy, auxiliary devices, and heart transplantation. However, different treatment methods face great challenges. For example, drug therapy generally leads to recurrent symptoms in many patients, and biventricular pacing is not suitable for all patients. Patients, and even some patients' physical fitness does not meet the treatment requirements, resulting in abnormal reactions in the body. In addition, when the heart transplant is used for treatment, the source of heart donors is very limited.

Patent CN103480037A describes an injectable alginate-based biomaterial for adjuvant treatment of heart failure and its preparation method, including two systems, sodium alginate system and cross-linking agent system, and using a three-way needle to combine the two groups The mixed material has good hydrophilicity, good mechanical properties and resilience properties, and can have good compatibility with cardiomyocytes. After a certain period of time, it can be used as an adjuvant treatment for heart failure. Hydrogel injected into the spherically dilated myocardial wall can improve or enhance myocardial function, repair myocardial tissue damage, reshape the ventricle, reduce the effective size of the ventricle, reduce the tension of the ventricular wall, and increase the ejection fraction, thereby achieving adjuvant therapy The purpose of heart failure is to prevent the deterioration of heart failure. The material of this scheme has good cell compatibility and mechanical properties, and is simple and convenient to operate, which greatly reduces the safety of clinical application and reduces the risk of over-reaction or over-reaction in current cross-linking methods. The problem of uneven response caused by too slow, so that the operation process can be controlled and managed. The implantable hydrogel is performed through a surgical operation. The patient is opened with a small incision, and 5-10mL is used in the left ventricular free wall. Syringe injection of hydrogel mainly includes the following steps: After the patient is anesthetized, the surgeon cuts an opening in the left intercostal space of the patient, opens the pericardium, fully exposes the position of the left ventricular free wall, and divides the middle horizontal line of the left ventricular free wall. As the injection site, use a surgical marking pen to draw multiple parallel straight lines on the surface of the free wall of the left ventricle as injection marking lines. Marking points are marked on each marking line, and the distance between the marking points ranges from about 1 to 2 cm. The dots covered the left ventricular free wall, and then the needle of the syringe was used to inject the hydrogel individually into the ventricular wall through each marked dot. During the operation, in order to minimize the harm to the patient, it is necessary to strictly control the incision size of the thoracotomy. However, the operation such as marking and injection in the smallest possible incision, because the exposed chest space is very narrow, During the process of marking the line and marking the injection point, the doctor’s field of vision is limited, and he can only operate with one hand, which is difficult; and during the whole operation, the heart is always beating, and the doctor uses a marking pen to draw a marking line on the surface of the heart It is relatively difficult to operate with the positioning point, which will greatly prolong the operation time and increase the risk of the patient; and because the heart is exposed to the air for a long time, the trauma to the patient will be relatively large. At the same time, the pigment used in the logo will diffuse or even fall off during the beating process of the heart, causing the injection point of the mark to blur or even disappear, requiring repeated repainting, which further increases the difficulty of operation and affects the accuracy of the mark.

Patent CN112869849A discloses a thoracoscopic heart failure treatment system, including a puncture device, a myocardial filling device, and an imaging device. The puncture device includes a first channel and a second channel, and the first channel is used to provide the myocardial filling A track for the device to enter the thoracic cavity from the outside, and the second channel is used to provide a track for the imaging device to enter the thoracic cavity from the outside; the myocardial filling device includes an injection device, a filler, an injection needle and an injection tube, and the injection The device includes an injection control device, the injection control device is arranged on the injection tube, and the injection control device is operated to inject the filler into the myocardial tissue through the injection needle; the imaging device includes an image receiving device component, image processing component and display device, the image of the distal part of the injection needle and/or the injection tube is displayed on the imaging device; For patients with too much trauma, postoperative recovery is slow, and the intraoperative time is long, with the risk of complications.

Patent CN107638615A proposes an auxiliary device for ventricular wall injection, which includes a flexible strip-shaped body made of biocompatible materials, a plurality of positioning holes are distributed on the strip-shaped body, and a plurality of vacuum suction cups are arranged on the back of the positioning holes. A detachable connection is formed between the outer surfaces of the heart to fix the strip-shaped main body on the outer surface of the heart. The operator can inject non-contractile substances such as hydrogels into different areas of the ventricular wall through the positioning holes and injection needles, effectively improving the The positioning accuracy of the injection point can shorten the operation time and avoid the residual pigment pollution in the patient's body. However, this kind of thoracotomy still brings trauma to the patient, and the clinical operation is bound to be troublesome. The doctor's field of vision is also limited during the operation.

Therefore, it is an urgent problem to be solved to change the surgical risks caused by large trauma, low injection efficiency, poor injection treatment effect, and easy fall-off of injections during the clinical operation process in the prior art.

Contents of the invention

In view of the above and other further ideas, the present application is made.

One of the purposes of this application is to overcome the deficiencies in the prior art, and provide a heart failure treatment system for problems such as large thoracotomy trauma, low injection efficiency, poor injection treatment effect, and easy fall-off of injections during clinical operations. .

According to another aspect of the present application, a heart failure treatment system is provided, including: a control mechanism, a delivery catheter connected to the control mechanism, and an injection module arranged in the delivery catheter; wherein, the distal part of the injection module has a preset shape; and a guiding and positioning device, the guiding and positioning device is at least partially disposed in the delivery catheter; when the distal end of the delivery catheter reaches the target position, and the injection module is gradually moved from the delivery catheter When extending distally, the guiding and positioning device can ensure that the distal portion of the injection module can return to a preset shape according to a predetermined route.

According to an embodiment, the target location is the surface of myocardial tissue.

According to an embodiment, the guide and positioning device includes an abutment partially arranged at the distal end of the delivery catheter; a guiding track is provided in the abutment, so that the distal part of the injection module can The route returns to its default form.

According to an embodiment, the guide and positioning device includes a guide block; wherein, the guide block is arranged at the distal end region of the injection module and is located on the proximal end side of the abutment member, and the guide block is provided with a guide hole; and, the center of the guide hole is set coaxially with the center of the proximal end of the guide track.

According to an embodiment, the guide and positioning device includes a circumferential limiting sleeve; wherein, the circumferential limiting sleeve is sleeved on the outer circumference of the abutment member and the guide block, and limits the abutment member and the outer circumference of the guide block. The guide block rotates circumferentially.

According to an embodiment, the outer circumferences of the abutment piece and the guide block are substantially polygonal, and the abutment piece and the guide block can be embedded in the circumferential limiting sleeve; and, the guide The block can only move axially relative to the abutment, and cannot rotate circumferentially; or, a circumferential limit track is provided in the circumferential limit set, and the guide block is arranged on the circumferential limit set Inside, it can axially slide relative to the abutment along the circumferential limiting track and cannot rotate circumferentially.

According to an embodiment, the proximal end region of the abutment is provided with a circumferential limit track, and the guide block can slide axially relative to the abutment along the circumferential limit track and cannot rotate circumferentially. .

According to an embodiment, the injection module includes one or more injection needles, a withdrawal judgment lumen, and an injection lumen; wherein, the injection needle is arranged at the withdrawal judgment lumen or the injection lumen The distal end, the withdrawing judging lumen is arranged side by side in parallel with the injection lumen or interspersed; the distal area of the withdrawing judging lumen, the distal end area of the injection lumen, and all the injection needles Alternatively, the injection lumen forms a first fluid communication channel with one or more of the injection needles, and the withdrawal judgment lumen forms a second fluid communication channel with the other injection needles , the first fluid communication channel does not form fluid communication with the second fluid communication channel, but the needle tip of the injection needle constituting the first fluid communication channel and the needle tip of the second fluid communication channel are restored to a preset configuration. The distance between the needle tips of the adjacent injection needles is ≤10mm; wherein, the distal portion of the injection needle has a predetermined arc; and the guide track has a predetermined curvature that is substantially close to the distal portion of the injection needle Set radians.

According to an embodiment, the injection needle is provided with a limiting structure, and the guide hole and/or guide track is provided with a limiting slide rail; the limiting structure can slide axially along the limiting slide rail and The circumferential rotation of the injection needle is limited; the position-limiting structure can be a tendon-like structure or a convex point.

According to an embodiment, the cross-section of the injection needle may be circular or irregular; the cross-sectional shape of the guide hole and/or the guide track matches the cross-section of the injection needle.

According to one embodiment, the injection needles include at least two, all the injection needles can be arranged eccentrically (non-uniform radial distribution), and the distal parts of all the injection needles can also radiate uniformly in all directions around an axis (radiant distribution). shape distribution).

According to another embodiment, the injection needle only includes one, and the distal end portion of the injection needle has a preset arc.

According to one embodiment, the part where the injection needle penetrates into the tissue distally is called the output section, and the output section is provided with an injection hole. The purpose of this design is that the injection can be injected into the myocardial tissue in all directions. Inside, improve the efficiency and effect of injection.

According to an embodiment, the heart failure treatment system further includes an injection, and the injection is preferably a myocardial injection gel.

According to an embodiment, an injection track is provided in the control mechanism, and the recovery judging lumen or the injection lumen or the proximal end of the injection lumen is set in the injection track; and, the injection The center of the track is arranged coaxially with the center of the abutment; and the recovery judging lumen or the injection lumen can only move axially but cannot rotate circumferentially relative to the abutment.

According to an embodiment, the far side of the guide track is provided with a leak-proof structure; and the leak-proof structure is configured in a concave shape; or, the distal peripheral area of the abutting member is provided with a deformable buffer structure, the buffer structure will not cover the guide track; the deformable buffer structure can adapt to the shape of the myocardial tissue, and can avoid the abutting member from stabbing the myocardial tissue; the deformable buffer structure can have a developing type for easy positioning of the abutment.

In a preferred embodiment, the number of the injection needles is 4, and when the injection module gradually protrudes distally from the guide assembly, the 4 injection needles diverge in 4 different directions to expand the The radiation range of its injection further improves the injection efficiency.

According to an embodiment, the injection needle is made of a memory alloy material, such as nickel-titanium alloy.

According to one embodiment, the distal end of the injection needle is provided with a sharp part, so as to penetrate into the tissue.

According to an embodiment, the vertical distance between the most distally extending end of the injection module and the distal end of the abutting member is 1-10 mm.

According to an embodiment, the vertical distance from the most distally extending end of the injection module to the distal end of the abutting member is 4-6 mm.

In a preferred embodiment, the vertical distance from the most distally extending end of the injection module to the distal end of the abutting member is 5 mm.

According to one embodiment, the guiding and positioning device is at least partly arranged at the distal end portion of the delivery catheter: and the delivery catheter includes a guiding assembly and an abutting tube; when pre-installed, the abutting tube is arranged on The guide assembly enters into the ventricle synchronously with the guide assembly, and the distal end of the abutting tube protrudes from the guide assembly and vertically abuts against the surface of the myocardium.

According to an embodiment, the guiding assembly includes two or more bending adjustment sheaths, so that the guiding assembly can comply with multiple positions and different angles of bending; and, when the distal end of the guiding assembly After the part enters the ventricle, the distal end against the tube is perpendicular to the surface of the myocardial tissue; the purpose of this design is to ensure that the injection needle can better enter the tissue.

According to one embodiment, the distal end of the abutment is provided with a buffer structure to protect the tissue; the buffer structure may be an elastic material provided on the surface of the abutment, such as silicone, when the abutment is against the surface of the tissue , can play an effective buffer role, thereby protecting the tissue.

According to an embodiment, the abutting member further includes a balloon, and when the abutting member enters the ventricle, the operation control mechanism is operated to pour liquid into the balloon, so that it can be visualized and facilitates the positioning of the abutting member.

According to an embodiment, it also includes an injection judging device; the injection judging device is arranged on the control mechanism, and liquid is distributed inside the control mechanism and the injection module; when the distal end of the injection needle is pierced When the needle enters the tissue, pull the injection judging device, and the injection judging device will return to the initial position; Return to the initial position; when the injection needle reaches the target position, it can be judged whether the distal end of the injection needle has penetrated into the myocardial tissue by pulling the injection judging device.

According to an embodiment, both the distal end portion of the injection needle and/or the guide block and the abutting member have a developing function; and when the guiding assembly is delivered to the target position, the developing function can be used judging whether the abutting piece is close to the target injection position; and observing the relative position of the distal end portion of the injection needle or the guide block and the abutting piece to judge the needle-exiting effect of the injection needle.

According to another embodiment, a manipulation mechanism, a delivery catheter, an abutment, an injection module, and a guide positioning device; wherein, the abutment is arranged on the distal side of the delivery catheter, and the distal end portion of the injection module has a predetermined and, when pre-assembled, the distal end portion of the injection module is limited in the abutment; and a guide positioning device, the guide positioning device is arranged in the delivery catheter; when the abutment The part is close to the target position, and when the injection module gradually extends distally from the abutment part, the guide and positioning device can ensure that the distal part of the injection module can return to the preset shape according to the predetermined route .

According to an embodiment, the abutting member is provided with at least one of the following: a pressure sensor, an electrocardiographic signal electrode, a magnetic navigation signal sensor, an optical signal sensor, and an ultrasonic sensor; wherein, the pressure sensor or the ultrasonic sensor or the optical sensor The signal sensor can be used to detect whether the abutment is against the target injection position; the electrocardiographic signal electrode is used to collect cardiac electrophysiological signals; the magnetic navigation signal sensor is used to guide the positioning of the abutment.

According to an embodiment, the pressure sensor is arranged in the central area of the most distal end of the abutment; the pressure sensor can effectively transmit whether the abutment is in close contact with the tissue, so as to determine whether the needle needs to be removed later.

According to another embodiment, a heart failure treatment system includes: a manipulation mechanism, a guide assembly, an injection module, an injection, and an auxiliary positioning mechanism; wherein, part or all of the guide assembly is arranged on the control mechanism. distally; and when pre-assembled, the injection module is constrained within the guide assembly; wherein the auxiliary positioning mechanism releases within the ventricle and guides the distal side of the guide assembly to a target injection site, and, The injection module gradually extends from the guide assembly in multiple distal directions and returns to a preset shape, and the injection is delivered to positions in multiple directions through the injection module and distributed in a divergent shape.

According to another embodiment, the auxiliary positioning mechanism is generally in the form of a ring or cage structure or a capsule structure, and the capsule structure is arranged at the distal end region of the heart failure treatment system and assists the heart failure treatment system. The aging treatment system completes positioning and injection.

According to another embodiment, the auxiliary positioning mechanism is a capsule structure, and the capsule structure includes at least one of the following: the interior of the capsule structure can be filled with gas or liquid; The surface has a concave, longitudinal or criss-cross textured structure, and the distal end region of the guiding component can be embedded in the textured structure.

According to another embodiment, it also includes a guiding and positioning device; the guiding and positioning device is arranged in the delivery catheter; and when the injection module gradually extends distally from the delivery catheter, the guiding and positioning device It can ensure that the distal portion of the injection module can return to a preset configuration according to a predetermined route.

Compared with the prior art, the advantages of the technical solution of the present application at least include the following:

In the prior art, there is only a thoracotomy approach for injecting gel into the patient's myocardial tissue. This method takes a long time for the operation and causes great trauma to the patient. At the same time, the myocardial tissue per unit area has a limited tolerance to the gel, resulting in Injection efficiency is low; in one embodiment of the present application, the distal part of the injection module has a preset radian or curvature, which can effectively increase the stroke of the injection needle in the tissue and expand the radiation range of its injection. At the same time, the guide The positioning device can ensure that the distal part of the injection module returns to a preset shape according to a predetermined route, effectively avoiding the deflection of the injection module during the needle ejection process and deviating from the target injection position.

According to a concept of the present application, the injection module includes a plurality of injection needles. Considering that the myocardial wall of patients with heart failure is thin, the distal parts of the injection needles can be distributed uniformly in all directions around an axis, or can be distributed eccentrically. , so that it can ensure that the injection needle can effectively penetrate into the tissue and achieve treatment. When the distal end of the injection needle penetrates into the target tissue obliquely, or when the distal end of the injection needle is only attached to the surface of the papillary muscle, it cannot ensure that all the injection needles are Puncture into the tissue, and the "off-center distribution" can minimize the injectable injection into non-target areas, including the left ventricular cavity, which will cause the fatal risk of injectable blockage of coronary arteries or cerebral blood vessels; multiple injection needles are synchronized at the same time Injection achieves single, multi-directional, targeted injection of gel into myocardial tissue, overcomes the technical difficulty of low injection efficiency caused by the limited amount of gel injection per unit area of myocardial tissue, and greatly improves injection efficiency and injection effect , shorten the operation time and improve the success rate of operation, which has good clinical significance.

According to a concept of the present application, it can be known from the physiological and anatomical test data that the thickness of myocardial tissue is 10-15mm, and the injection point of the gel in the myocardial tissue is between 1/2 to 1/3 of the thickness of the myocardial tissue. Therefore, in the present application, the vertical distance from the most distal end of the injection module to the distal end of the abutting member is 3-10 mm.

According to a concept of the present application, both the distal part of the injection needle and the abutment have the function of developing under X-ray, so that the positional relationship between the abutment and the target injection point can be observed in real time after the guide assembly enters the ventricle, and at the same time, The needle-exiting position and the needle-exiting effect of the injection needle can be judged by the relative position of the injection needle and the abutment member, which has very high practicability and has good clinical significance.

According to another concept of the present application, the abutment provides a positioning function for the injection module, so that the injection module can reach the target injection position more accurately. At the same time, the abutment also has a leak-proof structure that causes a concave shape, which can Effectively gather the tissue and play a leak-proof effect; and, when the injection module reaches the target position, the injection module gradually extends from the guide assembly to the distal side in multiple directions and restores to a preset shape and injects the gel into the myocardial tissue , to achieve a single, multi-directional, radial injection of gel into myocardial tissue, overcome the technical difficulties of low injection efficiency caused by the limited amount of gel injection per unit area of myocardial tissue, and greatly improve the injection efficiency and injection effect, The operation time is shortened.

According to another concept of the present application, the auxiliary positioning mechanism provides an auxiliary positioning function for the injection module, the auxiliary positioning mechanism can guide the far side of the injection module to reach the target injection position, and the auxiliary positioning mechanism can also provide certain support for the injection module Force, to avoid the situation that the injection module is pulled out during the injection process.

According to another idea of the present application, the part where the injection needle penetrates into the tissue distally is the output section, and the output section is provided with an injection hole. The purpose of this design is: the injection can be injected into the myocardial tissue in all directions, improving Injection efficiency and effect.

Embodiments of the present application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below, and are expected and understood by those skilled in the art after reading the present application of.

Description of drawings

The above-mentioned and other features and advantages of these embodiments, and the manner in which they are achieved, will become more apparent and a better understanding of embodiments of the present application can be obtained by referring to the following description together with the accompanying drawings in which:

Figures 1a-1f are schematic diagrams of the overall structure of the control mechanism, delivery catheter, injection module, injection material, guiding and positioning device, abutting member and injection judging device of the present application, as well as the needle-exiting schematic diagrams of the guide needle and the injection needle.

2a-2i are the structural schematic diagrams of the injection module of the present application, the schematic diagrams of the process of injecting the injection needle into the heart tissue, and the schematic diagrams of the cooperation between the guiding and positioning device and the abutment.

3a to 3k are structural schematic diagrams of the guiding and positioning device of the present application.

4a-4f are schematic diagrams of the injection module entering the heart tissue and injecting after the abutting member of the present application has abutted against the heart tissue.

Figures 5a to 5d show that the guide assembly of the present application passes through the femoral artery, complies with the aortic arch, then bends through the first layer of bending sheath to pass through the position of the aortic valve, then reaches the left ventricle, and finally passes through the second layer of adjusting sheath. Schematic diagram of the process of bending the sheath so that its distal end is perpendicular to the myocardial tissue.

Fig. 6 is a structural schematic diagram of a delivery catheter including three bending-adjusting sheaths of the present application.

Figures 7a-7g show that the delivery catheter of the present application passes through the femoral vein, then through the inferior vena cava, and then enters the right atrium, and then bends through the first layer of bending sheath to pass through the interatrial septum to the left atrium, and then passes through the second The second-layer bend-adjusting sheath is bent to align with the mitral valve annulus and enter the left ventricle, and finally the abutting member is vertically touched to the myocardial tissue by bending through the third-layer bend-adjusting sheath.

Figures 8a-8c are structural schematic diagrams of the pressure sensor, ECG signal electrode and magnetic navigation signal sensor installed on the abutment of the present application

9a and 9b are schematic diagrams of the auxiliary positioning mechanism of the present application assisting the delivery catheter to tightly contact the tissue surface.

10a and 10b are structural schematic diagrams of the eccentric distribution of the injection needles of the present application.

Figures 11a and 11b are schematic structural views of the embodiment of the single injection needle of the present application.

The features indicated by each number in the accompanying drawings are as follows:

1-manipulation mechanism, 11-injection track, 2-delivery catheter, 21-guiding assembly, 22-against the tube, 3-injection module, 31-injection needle, 311-output section, 3111-injection hole, 312-limit Position structure, 32-recovery judgment lumen, 33-injection lumen, 34-first fluid communication channel, 35-second fluid communication channel, 4-injection, 5-guiding and positioning device, 51-guiding block, 511- Guide hole, 512-Guide head, 513-Ball, 52-Circumferential limit kit, 521-Slider guide rail, 522-Ball guide rail, 6-Abutting piece, 61-Guide rail, 611-Leakage-proof structure, 612 -buffer structure, 62-pressure sensor, 63-electrocardiogram signal electrode, 64-magnetic navigation signal sensor, 7-injection judgment device, 8-auxiliary positioning mechanism, 81-capsular structure, 811-texture structure, 82-guide Structure, 9-limit slide rail.

detailed description

The details of one or more embodiments of the application are set forth in the following description of the accompanying drawings and the detailed description. Other features, objects and advantages of the present application will be apparent from the description, drawings and claims.

It should be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments are capable of other embodiments and of being practiced or carried out in various ways. Each example is provided by way of explanation, not limitation, of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the various embodiments of the present application without departing from the scope or spirit of the present disclosure. For example, features illustrated or described as part of one embodiment, can be used with another embodiment to still yield a further embodiment. Accordingly, it is intended that the present disclosure covers such modifications and alterations as come within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phrases and terms used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising", "comprising" or "having" and variations thereof herein is intended to openly include the items listed thereafter and equivalents thereof as well as additional items.

The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

In this application, the term "proximal" or "proximal" refers to the end or side closer to the operator, and "distal" or "distal" refers to the end or side farther away from the operator. side.

In the prior art, there is only a thoracotomy approach for injecting gel into the patient's myocardial tissue. This method takes a long time and causes great trauma to the patient. At the same time, the far side of the injection needle used is straight, and because The gel capacity per unit area of myocardial tissue is limited, resulting in low injection efficiency.

One of the objectives of the embodiments described below is to address the above-mentioned drawbacks, among others.

Embodiment one

As shown in Figures 1a and 1b, a heart failure treatment system according to an embodiment of the present application is illustrated, including: a manipulation mechanism 1, a delivery catheter 2 connected to the manipulation mechanism 1, and an injection module arranged in the delivery catheter 2 3; wherein, the distal end portion of the injection module 3 has a preset shape; and a guide positioning device 5, the guide positioning device 5 is at least partly arranged in the delivery catheter 2; when the delivery catheter 2 is far When the end of the injection module 3 reaches the target position, and the injection module 3 gradually extends distally from the delivery catheter 2, the guide and positioning device 5 can ensure that the distal part of the injection module 3 can return to the predetermined route according to the predetermined route. Set the form.

In the first embodiment, the target location is the surface of the myocardial tissue, and the injection module 3 injects the gel from the endocardium to the epicardium, as shown in FIGS. 2c-2e.

In the first embodiment, the guiding and positioning device 5 includes an abutment 6 partially disposed at the distal end of the delivery catheter 2; a guide track 61 is provided in the abutment 6, so that the injection module 3 The distal part of the device can return to a preset shape according to a predetermined route.

In the first embodiment, the guide positioning device 5 includes a guide block 51; wherein, the guide block 51 is arranged on the proximal side of the abutting member 6, and the guide block 51 is provided with a guide hole 511; and , the center of the guide hole 511 is arranged coaxially with the center of the proximal end of the guide rail 61, as shown in FIGS. 3a and 3b.

In the first embodiment, the guide and positioning device 5 includes a circumferential limiting sleeve 52, as shown in Figure 3c-3e; the outer periphery of the guide block 51 , and restrict the circumferential rotation of the abutting member 6 and the guide block 51 .

In the first embodiment, the outer circumference of the abutment 6 and the guide block 51 is substantially polygonal; and the abutment 6 and the guide block 51 can be embedded in the circumferential limit sleeve 52; or, as shown in Figures 3i-3k; the circumferential limit set 52 is provided with a circumferential limit track 521, and the guide block 51 is arranged in the circumferential limit set 52, which can Along the circumferential limit track 521, it slides axially relative to the abutment 6 and cannot rotate in the circumferential direction; the purpose of this design is to prevent the guide block 51 and the abutment 6 from rotating in the circumferential direction, and prevent the injection module 3 from Circumferential twist occurs when the needle is pulled out, so that it can return to the preset shape according to the predetermined route.

In the first embodiment, a ball 513 can be arranged on the guide block 51 , and the ball 513 can slide axially in the ball track 522 and limit the circumferential rotation of the guide block 51 .

In the present embodiment one, as shown in Figure 3f～3h; the length of the circumferential limit set 52 can be lengthened, and the internal structure of the circumferential limit set 52 is generally a quadrilateral slider guide rail 521, the guide of the guide block 51 The head 512 and the proximal portion of the abutting member 6 are correspondingly configured to be substantially quadrangular so as to be embedded in the circumferential limiting sleeve 52 and prevent the guide block 51 and the abutting member 6 from rotating in the circumferential direction.

In the first embodiment, the injection module 3 includes a plurality of injection needles 31, a recovery judgment lumen 32 and an injection lumen 33, as shown in FIG. 1a; wherein, the injection needle 31 is set in the recovery judgment lumen 32 or the distal end of the injection lumen 33, the withdrawal judging lumen 32 and the injection lumen 33 are arranged side by side in parallel or interspersed; the distal area of the withdrawal judging lumen 32, the The distal end area of the injection lumen 33 is in fluid communication with all the injection needles 31, or the injection lumen 33 respectively forms a first fluid communication channel 34 with one or more of the injection needles 31, and the withdrawal It is judged that the lumen 32 forms the second fluid communication channel 35 with the other injection needles 31, and the first fluid communication channel 34 does not form fluid communication with the second fluid communication channel 35, but returns to the preset shape to form the second fluid communication channel 35. The distance between the needle tip of the injection needle 31 of a fluid communication channel 34 and the needle tip of the adjacent injection needle 31 constituting the second fluid communication channel 35 is ≤ 10mm; wherein, the distal part of the injection needle 31 has a predetermined and the guide track 61 has a preset arc that is substantially close to the distal end portion of the injection needle 31 .

In the first embodiment, the number of the injection needles 31 is 4, as shown in Figure 2a, and when the injection module 3 gradually protrudes from the guide mechanism 2 to the far side, the 4 injection needles 31 respectively Diverge in different directions to expand the radiation range of the injection and further improve the injection efficiency. At the same time, the distal parts of the four injection needles 31 are inserted into the myocardial tissue to form an "anchor-shaped" structure, which can effectively prevent the injection needles 31 from being detached from the myocardial tissue during the process.

In the first embodiment, the injection needle 31 is provided with a limit structure 312, and the guide hole 511 and/or the guide track 61 is provided with a limit slide rail 9; the limit structure 312 can move along the limit The positioning slide rail 9 slides axially and limits the circumferential rotation of the injection needle 31; the limiting structure 312 can be a rib-like structure or a convex point.

In the first embodiment, the cross-section of the injection needle 31 can be circular or irregular; for example, triangular or quadrilateral; The cross-section of the injection needle 31 is matched.

In the first embodiment, the distal part of the injection needle 31 pierced into the tissue is called the output section 311, and the output section 311 is provided with an injection hole 3111, as shown in Figure 2b, the purpose of this design is to : Injection 4 can be injected into myocardial tissue in all directions, improving the efficiency and effect of injection.

In the first embodiment, in a natural state, the distal end of the injection needle 31 extends outward away from the center of the injection module 3 .

In the first embodiment, the injection 4 is preferably a myocardial injection gel.

In the first embodiment, the control mechanism 1 is provided with an injection track 11, and the recovery judging lumen or the proximal end of the injection lumen 32 is set in the injection track 11; and, the injection track The center of 11 is arranged coaxially with the center of the abutting member 6; and, the recovery judging lumen or the injection lumen 32 can only move axially relative to the abutting member 6 and cannot rotate circumferentially.

In the first embodiment, an anti-leakage structure 611 is provided on the far side of the guide track 61; moreover, the anti-leakage structure 611 is configured in a concave shape, as shown in FIG. 2e.

In the first embodiment, the injection needle 31 is made of memory alloy material, such as nickel-titanium alloy.

In the first embodiment, the distal end of the injection needle 31 is provided with a sharp part, so as to penetrate into the tissue.

In the first embodiment, the vertical distance from the most distal end of the injection module 3 to the distal end of the abutting member 6 is 5 mm.

In the first embodiment, the guide and positioning device 5 is at least partly arranged at the distal end of the delivery catheter 2: and the delivery catheter 2 includes a guide assembly 21 and abutting tube 22; when pre-installed, the The abutment tube 22 is set in the guide assembly 21 and enters the ventricle synchronously with the guide assembly 21. The distal end of the abutment tube 22 protrudes from the guide assembly 21 and vertically abuts on the Myocardial surface.

In the first embodiment, the guide assembly 21 includes two bend-adjusting sheaths, the guide assembly 21 passes through the femoral artery, and conforms to the aortic arch, and then bends through the first layer of bend-adjusting sheaths to pass through the position of the aortic valve , and then reach the left ventricle, and finally through the second layer of bending sheath to make its distal end vertically reach the myocardial tissue.

In the first embodiment, the distal end of the abutment 6 is provided with a buffer structure 612 to protect the tissue; the buffer structure 612 can be an elastic material provided on the surface of the abutment 6, such as: silica gel, when the abutment 6 When touching the surface of the tissue, it can play an effective buffering role, thereby protecting the tissue.

In the first embodiment, an injection judging device 7 is also included, as shown in FIG. There is liquid; when the distal end of the injection needle 31 is pierced into the tissue, pull the injection judging device 7, and the injection judging device 7 will return to the initial position; when the injection needle 31 is not pierced into the tissue When the injection judging device 7 is pulled, the injection judging device 7 will not return to the initial position; into the heart muscle.

In the first embodiment, the distal part of the injection needle 31 and the pressing head 6 both have the function of developing under X-ray, so that the position of the pressing head 6 and the target injection point can be observed in real time after the distal part of the delivery catheter 2 enters the ventricle At the same time, through the relative position of the distal end of the injection needle 31 and the pressing head 6, the needle-exiting position and the needle-exiting effect of the injection needle 31 can be judged, which is very practical and has good clinical significance.

An exemplary operation process of injecting gel into the inner wall of the left ventricle of the heart failure treatment system of the first embodiment is as follows:

1. Bending is delivered to the left ventricle: the guide assembly 21 includes two bend-adjusting sheaths. The guide assembly 21 passes through the femoral artery, conforms to the aortic arch, and then bends through the aortic valve through the first layer of bend-adjusting sheaths. position, then reach the left ventricle, and finally make the distal end reach the myocardial tissue vertically through the second layer of bending sheath, as shown in Figure 5a-5d;

2. The injection module 3 enters the myocardium: when the abutment 6 is pressed against the myocardium, the distal end of the injection needle 31 protrudes from the guide rail 61 of the abutment 6 and penetrates into the myocardium;

3. Judgment: pull the injection judging device 7, if the injection judging device 7 will return to the initial position, it means that the distal end of the injection needle 31 has penetrated into the myocardial tissue, and continue to the next step; if the injection judging device 7 will not return to the original position to the initial position, then withdraw the injection needle 31 into the guide mechanism 2 according to the original route, and search for the target injection position again;

4. Injection gel: the injection gel is delivered to positions in multiple directions through four injection needles 31 and distributed radially, as shown in Figures 4a-4d.

Embodiment two

Embodiment 2 is generally the same as Embodiment 1, except that the way of the surgical approach is different.

As shown in FIG. 6 , a heart failure treatment system according to an embodiment of the present application is illustrated, including: a control mechanism 1, a delivery catheter 2, an injection module 3 and an injection 4; wherein, the part of the delivery catheter 2 Or all of them are arranged on the far side of the manipulation mechanism 1; and, the injection module 3 reaches the target injection position through the delivery catheter 2; when pre-installed, the injection module 3 is limited in the delivery catheter 2; Wherein, when the distal end of the delivery catheter 2 reaches the target position, the injection module 3 gradually extends from the delivery catheter 2 to multiple distal directions and returns to a preset shape; and, the injection 4 is conveyed by the injection module 3 to positions in multiple directions.

In the second embodiment, the guiding assembly 21 includes three bending-adjusting sheaths. The guiding assembly 21 passes through the femoral vein, then passes through the inferior vena cava, and then enters the right atrium. Pass through the interatrial septum to reach the left atrium, then align it with the mitral valve annulus through the second layer of bending sheath and enter the left ventricle, and finally bend it through the third layer of bending sheath to make it against The piece 6 is perpendicular to the myocardial tissue, as shown in Figs. 7a-7g.

Generally similar to Embodiment 1, when the abutting member 6 is pressed against the myocardial tissue, the distal end of the injection needle 31 protrudes from the guide rail 61 of the abutting member 6 and penetrates into the myocardial tissue, injecting the gel The four injection needles 31 are delivered to positions in multiple directions and distributed radially.

In this regard, the relevant structure and idea of the second embodiment are similar to the first embodiment, so the description will not be repeated here.

Embodiment Three

The third embodiment is basically the same as the first embodiment, except that the abutting member 6 in this embodiment has functions of developing, positioning and providing buffer.

As shown in Figures 8a-8c, a heart failure treatment system according to an embodiment of the present application is illustrated, including: a manipulation mechanism 1, a delivery catheter 2, an abutment 6, an injection module 3, and an injection 4; wherein, A part or all of the delivery catheter 2 is arranged on the distal side of the manipulation mechanism 1, the delivery catheter 2 includes two or more bending adjustment sheaths, and the abutting member 6 is arranged on the innermost adjustment sheath. The interior of the distal side of the curved sheath; or, a pressing assembly (not shown) is axially laid between the bending sheath and the injection module 3, and a pressing assembly (not shown) is arranged at the distal end of the pressing assembly (not shown). abutment 6; and the injection module 3 reaches the target injection position through the delivery catheter 2; when pre-installed, the injection module 3 is limited in the delivery catheter 2; wherein, the far part of the injection module 3 The end is positioned to the target injection position through the abutment 6 and extends from the delivery catheter 2 to multiple directions of the distal side gradually and restores to a preset shape; and, the injection 4 passes through the injection module 3 Delivered to locations in multiple directions.

In the third embodiment, the abutting member 6 can be made of a developing material or the surface of the abutting member 6 is coated with a developing material.

In the third embodiment, the abutting member 6 is provided with at least one of the following: a pressure sensor 62, an electrocardiographic signal electrode 63 and a magnetic navigation signal sensor 64; wherein, the pressure sensor 62 can be used to detect the abutment Whether the component 6 is against the target injection position; the electrocardiographic signal electrode 63 is used to collect cardiac electrophysiological signals; the magnetic navigation signal sensor 64 is used to guide the positioning of the abutting component 6 .

In the third embodiment, the pressure sensor 62 is arranged in the central area of the farthest end of the abutting member 6 .

In this regard, the relevant structure and idea of the third embodiment are similar to the first embodiment, so the description will not be repeated here.

Embodiment four

Embodiment 4 is basically the same as Embodiment 1, except that an auxiliary positioning mechanism 8 is added in this embodiment.

As shown in Figures 9a and 9b, a heart failure treatment system according to an embodiment of the present application is illustrated, including: a manipulation mechanism 1, a delivery catheter 2, an injection module 3, an injection 4 and an auxiliary positioning mechanism 8; wherein, A part or all of the delivery catheter 2 is disposed on the distal side of the manipulation mechanism 1; and when pre-installed, the injection module 3 is confined in the delivery catheter 2; wherein the auxiliary positioning mechanism 8 is centrally located release and guide the distal side of the delivery catheter 2 to the target injection site, and the injection module 3 gradually extends from the delivery catheter 2 to the distal side in multiple directions and restores to a preset shape. The objects 4 are transported to positions in multiple directions through the injection module 3 and distributed in a divergent shape.

In the fourth embodiment, the auxiliary positioning mechanism 8 is generally in the form of a ring or cage structure or a capsule structure 81 .

In the fourth embodiment, the auxiliary positioning mechanism 8 includes a guide structure 82. When the delivery catheter 2 passes through the blood vessel and enters the left ventricle, the delivery catheter 2 can conform to the guide structure 82 and extend to the target injection point. During the injection process, the auxiliary positioning mechanism 8 can provide a certain supporting force for the distal part of the delivery catheter 2 to ensure the stability of the injection process and prevent the injection needle 31 from being pulled out of the thread during the injection process.

In the fourth embodiment, the capsule structure 81 includes at least one of the following: the interior of the capsule structure 81 can be filled with gas or liquid, and when the interior of the capsule structure 81 is inflated, it cooperates with ultrasonic equipment , can be used to judge whether the delivery catheter 2 is tightly against the tissue surface; when the interior of the capsule structure 81 is filled with liquid, cooperate with X-ray equipment to determine whether the delivery catheter 2 is tightly against the tissue surface; the surface of the capsule structure 81 It has concave, longitudinal or criss-cross textured structure 811, and the distal end region of the delivery catheter 2 can be embedded in the textured structure 811, which can play the role of positioning and auxiliary support for the delivery catheter 2.

In this regard, the relevant structure and idea of the fourth embodiment are similar to those of the first embodiment, so the description will not be repeated here.

Embodiment five

Embodiment 5 is basically the same as Embodiment 1, except that in this embodiment, the injection needles 31 do not uniformly diverge in all directions around an axis, but are distributed eccentrically for a certain part of the patient, so that the injection 4. It can be injected to the desired target position in a targeted manner to improve the effect of injection treatment.

As shown in Figures 10a and 10b, a heart failure treatment system according to an embodiment of the present application is illustrated, including: a control mechanism 1, a delivery catheter 2, an injection module 3, and an injection 4; wherein, the delivery catheter 2 part or all of which is arranged on the far side of the manipulation mechanism 1; and, the injection module 3 reaches the target injection position through the delivery catheter 2; inside; wherein, when the distal end of the delivery catheter 2 reaches the target position, the injection module 3 gradually extends from the delivery catheter 2 to multiple distal directions and returns to a preset shape; and, the The injection 4 is transported to positions in multiple directions through the injection module 3 .

In the fifth embodiment, since the myocardial wall of heart failure patients is relatively thin, when the distal end of the delivery catheter 2 reaches the target position, the plurality of injection needles 31 gradually extend from the delivery catheter 2 and return to preset shape, and all the distal parts of the injection needles 31 are concentrated in a certain direction or a certain area, which can effectively avoid the injection of the injection 4 into the non-target area, including the left ventricular cavity, and cause the injection The fatal risk of blockage of coronary arteries or cerebral blood vessels by substance 4; at the same time, it can be more targeted for injection treatment to a certain area, and the injection efficiency and injection effect can be improved, which has good clinical significance.

In this regard, the relevant structure and concept of the fifth embodiment are similar to the first embodiment, so no repeated description is given here.

Embodiment six

Embodiment 6 is substantially the same as Embodiment 1, except that the injection module in this embodiment only consists of a single injection needle.

As shown in Figures 11a and 11b, a heart failure treatment system according to an embodiment of the present application is illustrated, including: a manipulation mechanism 1, a delivery catheter 2, an injection module 3, and an injection 4; wherein the delivery catheter 2 Part or all of it is arranged on the far side of the manipulation mechanism 1; the injection module 3 is composed of a single injection needle 31, and the injection module 3 reaches the target injection position through the delivery catheter 2; when pre-installed, The injection module 3 is confined within the delivery catheter 2; wherein, when the distal end of the delivery catheter 2 reaches the target position, the injection module 3 gradually extends distally from the delivery catheter 2 and recovers It is in a preset form; and, the injection 4 is transported to the target position through the injection module 3 .

In this regard, the relevant structure and idea of the sixth embodiment are similar to those of the first embodiment, so the description will not be repeated here.

The foregoing description of several embodiments of the present application have been presented for purposes of illustration. The foregoing description is not intended to be exhaustive, nor to limit the application to the precise configuration, construction and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention and all equivalents be defined by the claims appended hereto.

Claims (22)

1. A heart failure treatment system comprising:

   a control mechanism, a delivery catheter connected to the control mechanism, and an injection module arranged in the delivery catheter;

   wherein the distal portion of the injection block has a predetermined shape; and

   a guiding and positioning device disposed at least partially within the delivery catheter;

   When the distal end of the delivery catheter reaches the target position and the injection module gradually extends distally from the delivery catheter, the guide and positioning device can ensure that the distal part of the injection module can follow a predetermined route Return to default form.
2. The heart failure treatment system according to claim 1, wherein the guiding and positioning device comprises an abutment partially disposed at the distal end of the delivery catheter;

   A guiding track is provided in the abutting member, so that the distal portion of the injection module can return to a preset shape according to a predetermined route.
3. The heart failure treatment system according to claim 2, wherein said guiding and positioning device comprises a guiding block;

   Wherein, the guide block is arranged at the distal end area of the injection module, and is located on the proximal end side of the abutting member, and the guide block is provided with a guide hole; and, the center of the guide hole is aligned with the The central coaxial setting at the proximal end of the guide rail.
4. The heart failure treatment system according to claim 3, wherein said guiding and positioning device comprises a circumferential limiting sleeve;

   Wherein, the circumferential limiting sleeve is sleeved on the outer circumference of the abutment piece and the guide block, and limits the circumferential rotation of the abutment piece and the guide block.
5. The heart failure treatment system according to claim 4, wherein the outer circumference of the abutting member and the guide block is substantially polygonal, and the abutting member and the guide block can be embedded in the circumferential limit. and the guide block can only move axially relative to the abutment, and cannot rotate circumferentially;

   Alternatively, a circumferential limit track is provided in the circumferential limit set, and the guide block is arranged in the circumferential limit set, and can be opposed to the abutment along the circumferential limit track. Slips axially and cannot rotate circumferentially.
6. The heart failure treatment system according to claim 3, wherein the proximal end region of the abutting member is provided with a circumferential limiting track, and the guide block can be moved relative to the abutting piece along the circumferential limiting track. The seat slides axially and cannot rotate circumferentially.
7. The heart failure treatment system according to any one of claims 1-6, wherein the injection module comprises one or more injection needles, a withdrawal judgment lumen, and an injection lumen;

   Wherein, the injection needle is arranged at the withdrawal judging lumen or the distal end of the injection lumen, and the withdrawal judging lumen and the injection lumen are arranged side by side in parallel or interspersed;

   The distal region of the withdrawal judgment lumen, the distal region of the injection lumen, and all the injection needles are in fluid communication,

   Alternatively, the injection lumen respectively forms a first fluid communication channel with one or more of the injection needles, and the withdrawal judgment lumen forms a second fluid communication channel with other injection needles, and the first The fluid communication channel does not form fluid communication with the second fluid communication channel, but the needle tip of the injection needle constituting the first fluid communication channel and the adjacent injection needle constituting the second fluid communication channel return to the preset shape. The distance between the tip of the needle ≤ 10mm;

   Wherein, the distal portion of the injection needle has a predetermined curvature; and

   The guide track has a predetermined arc substantially close to the distal end portion of the injection needle.
8. The heart failure treatment system according to any one of claims 3-7, wherein a limiting structure is arranged on the injection needle, and a limiting slide rail is arranged in the guide hole and/or guiding track; The bit structure can slide axially along the limiting slide rail and limit the circumferential rotation of the injection needle.
9. The heart failure treatment system according to claim 7, wherein an injection track is provided in the control mechanism, and the recovery judging lumen or the injection lumen or the proximal end of the injection lumen is arranged on the Injection track;

   Moreover, the center of the injection track is arranged coaxially with the center of the abutment;

   Moreover, the recovery judging lumen or the injection lumen can only move axially relative to the abutment but cannot rotate circumferentially.
10. The heart failure treatment system according to claim 7, wherein an anti-leakage structure is provided on the far side of the guide track; and the anti-leakage structure is configured in a concave shape;

    Alternatively, a deformable buffer structure is provided on the distal peripheral region of the abutment, and the buffer structure does not cover the guide track.
11. The heart failure treatment system according to claim 7, wherein, the distal part of the injection needle and/or the guide block, and the abutting member both have a developing function;

    Moreover, when the delivery catheter is delivered to the target position, it is possible to use the developing function to judge whether the abutting member is close to the target injection position; and

    Observing the distal end portion of the injection needle or the relative position of the guide block and the abutting piece to judge the needle-exiting effect of the injection needle.
12. The heart failure treatment system according to claim 2, wherein the vertical distance from the most distal end of the injection module to the distal end of the abutting member is 1-10 mm.
13. The heart failure treatment system according to any one of claims 1-12, wherein the guiding and positioning device is at least partially disposed at the distal end portion of the delivery catheter: and

    The delivery catheter includes an introducer assembly and an abutment tubing;

    When pre-installed, the abutting tube is set in the guide assembly and enters the ventricle synchronously with the guide assembly, and the distal end of the abutting tube protrudes from the guide assembly and vertically abuts against on the surface of the myocardium.
14. The heart failure treatment system according to any one of claims 1-13, further comprising an injection judging device; the injection judging device is arranged on the control mechanism, and inside the control mechanism and the injection module Evenly distributed with liquid;

    When the distal end of the injection module penetrates into the tissue, the injection judging device is pulled, and the injection judging device returns to its original position;

    When the injection module is not pierced into the tissue, the injection judging device will not return to the original position if the injection judging device is pulled.
15. The heart failure treatment system according to any one of claims 1-13, further comprising a radiation-assisted judgment device; the radiation-assisted judgment device includes a judging fluid lumen, a radiation judging liquid, and a radiographic imaging device, and the judging The liquid chamber is axially laid in the delivery catheter, the distal area of the delivery catheter or the abutment is provided with several liquid outlet holes communicating with the judgment liquid chamber, and the radiographic judgment liquid is preloaded in the The judging liquid chamber is inside and can be discharged out of the system through the liquid outlet hole.
16. A heart failure treatment system comprising:

    Manipulation mechanism, delivery catheter, abutment, injection module and guide positioning device;

    Wherein, the abutment is disposed on the distal side of the delivery catheter, and the distal end portion of the injection module has a predetermined shape;

    And, when preassembled, the distal end portion of the injection module is constrained within the abutment; and

    a guiding and positioning device, the guiding and positioning device is arranged in the delivery catheter;

    When the abutment is close to the target position, and the injection module gradually extends distally from the abutment, the guide and positioning device can ensure that the distal part of the injection module can follow a predetermined route Return to default form.
17. The heart failure treatment system of claim 16, wherein the abutment is provided with at least one of the following:

    Pressure sensor, ECG signal electrode, magnetic navigation signal sensor, optical signal sensor and ultrasonic sensor;

    Wherein, the pressure sensor or the ultrasonic sensor or the optical signal sensor; can be used to detect whether the abutment is against the target injection position; the electrocardiographic signal electrode is used to collect cardiac electrophysiological signals; the magnetic navigation signal sensor is used to Guide the positioning of the abutment.
18. The heart failure treatment system according to claim 17, wherein the pressure sensor is disposed at a central region of the most distal end of the abutment.
19. A heart failure treatment system comprising:

    Manipulation mechanisms, delivery catheters, injection modules, injectables, and auxiliary positioning mechanisms;

    Wherein, the delivery catheter is connected to the steering mechanism, and the distal portion of the injection module has a predetermined configuration; and

    When pre-assembled, the injection module is constrained within the delivery catheter; wherein the auxiliary positioning mechanism releases in the ventricle and guides and supports the distal side of the delivery catheter to a target injection site;

    Moreover, the injection module gradually extends distally from the delivery catheter and returns to a preset shape, and the injection is delivered to a target position through the injection module.
20. The heart failure treatment system according to claim 19, wherein the auxiliary positioning mechanism is generally in the shape of a ring or a cage or a capsule;

    In addition, the capsule structure is arranged at the distal area of the heart failure treatment system and assists the heart failure treatment system to complete positioning and injection.
21. The heart failure treatment system according to claim 19, wherein the auxiliary positioning mechanism is a capsule structure, and the capsule structure includes at least one of the following:

    The interior of the capsule-shaped structure can be filled with gas or liquid; the surface of the capsule-shaped structure has a concave, longitudinal or criss-cross texture structure, and the distal end region of the delivery catheter can be embedded in the texture structure.
22. The heart failure treatment system according to any one of claims 19-21, further comprising a guiding and positioning device;

    the guiding and positioning device is disposed within the delivery catheter; and

    When the injection module gradually extends distally from the delivery catheter, the guiding and positioning device can ensure that the distal part of the injection module can return to a preset shape according to a predetermined route.

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