CN113577504A

CN113577504A - Heart failure treatment system

Info

Publication number: CN113577504A
Application number: CN202110791104.9A
Authority: CN
Inventors: 李彪; 吕世文; 陈超; 胡晓明
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2021-07-13
Filing date: 2021-07-13
Publication date: 2021-11-02
Also published as: CN217548755U; WO2023284361A1; CN114272490A; CN114392459A

Abstract

The application relates to the field of medical instruments, in particular to a heart failure treatment system, which comprises an operation and control mechanism, a conveying catheter connected with the operation and control mechanism, and an injection module arranged in the conveying catheter; wherein the distal portion of the injection module has a preset configuration; and a guide 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 extends gradually and distally from the delivery catheter, the guiding and positioning device can ensure that the distal end part of the injection module can return to the preset shape according to the preset route; the injection efficiency can be improved, and the injection effect can be improved.

Description

Heart failure treatment system

Technical Field

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

Background

At present, the morbidity and mortality of heart failure are high, which is a significant cause of death of most patients with cardiovascular diseases, and nearly 2300 million people all over the world suffer from the disease. The heart failure is called heart failure, which means that venous return blood cannot be sufficiently discharged out of the body due to the occurrence of dysfunction of the systolic function or the diastolic function of the heart, so that blood stasis in a venous system and insufficient blood supply in an arterial system are caused, and finally cardiac circulatory system dysfunction is caused. The development process of heart failure is slow, most of the heart failure is caused by that after various symptoms of a patient accumulate for many years, the heart gradually loses the blood pumping function, all the functions are gradually weakened, the heart is enlarged, and the left ventricle is enlarged, so that the life quality and clinical treatment of the patient are greatly influenced. The existing treatment schemes include drug therapy, auxiliary equipment and heart transplantation, but different treatment methods face great challenges, for example, the drug therapy generally causes repeated attacks of diseases of many patients, the treatment mode is not suitable for all patients through biventricular pacing, even the physical quality of some patients does not meet the treatment condition, the body has abnormal reactions, and in addition, when the treatment mode is performed through the heart transplantation, the source of heart donors is very limited.

Patent CN103480037A describes an injectable alginic acid-based biomaterial for adjuvant therapy of heart failure and a preparation method thereof, comprising two systems, a sodium alginate system and a cross-linking agent system, and the material prepared by mixing the two components by using a three-way needle has good hydrophilicity, good mechanical property and rebound property, good compatibility with cardiac muscle cells, and can be used for adjuvant therapy of heart failure after a certain time balance, the hydrogel prepared by the scheme is injected into the cardiac muscle wall which is spherically expanded, so that the cardiac muscle function can be improved, the injury of cardiac muscle tissue can be repaired, the ventricle can be regenerated, the effective size of the ventricle can be reduced, the ventricular wall tension can be reduced, the ejection fraction can be increased, the purpose of adjuvant therapy of heart failure can be achieved, the heart failure can be prevented from deteriorating, the material of the scheme has good cell compatibility and mechanical property, and the operation is simple and convenient, the safety of clinical application is greatly reduced, the problem of uneven reaction caused by too fast or too slow reaction in the existing crosslinking process method is solved, the operation process is controllably managed, implantable hydrogel is used for thoracotomy of a patient in a surgical operation mode, a 5-10 mL injector is used for injecting hydrogel into the free wall of the left ventricle, and the method mainly comprises the following steps: after a patient is anesthetized, a surgeon cuts an opening between left ribs of the patient, a pericardium is opened, the position of a free wall of a left ventricle of the heart is fully exposed, a middle horizontal line of the free wall of the left ventricle is used as an injection part, a plurality of parallel straight lines are drawn on the surface of the free wall of the left ventricle by using a surgical marking pen to serve as injection marking lines, marking points are marked on each marking line, the distance range between the marking points is about 1-2 cm, the marking points cover the free wall of the left ventricle, and then hydrogel is respectively injected into a ventricular wall by using a needle head of an injector through each marking point. In the operation process, in order to reduce the injury to the patient as much as possible, the size of the wound for opening the chest needs to be strictly controlled, however, the marking, injection and other operations are carried out in the incision as small as possible, because the exposed chest space is very narrow, the visual field of a doctor is limited in the processes of marking and marking the injection point, and the doctor can only operate by one hand frequently, so that the difficulty is high; in the whole operation process, the heart is in a beating state all the time, the operation that a doctor uses a marking pen to mark a marking line and a positioning point on the surface of the heart is difficult, the operation time can be greatly prolonged, and the risk of a patient is increased; and the heart can be exposed to air for a long time, which can cause a large trauma to the patient. Meanwhile, the pigment used for marking can also be diffused and even fall off in the process of heartbeat, so that the injection point of the marking is blurred and even disappears, repeated marking needs to be performed for many times, the operation difficulty is further increased, and the marking precision is influenced.

Patent CN112869849A discloses a thoracoscopic heart failure treatment system, which includes a puncturing device, a myocardial filling device, and an imaging device, wherein the puncturing device includes a first channel and a second channel, the first channel is used for providing a track for the myocardial filling device to enter the thoracic cavity from the outside of the body, and the second channel is used for providing a track for the imaging device to enter the thoracic cavity from the outside of the body; the myocardial filling device comprises an injection device, filler, an injection needle and an injection tube, wherein the injection device comprises 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 myocardial tissue through the injection needle; the imaging device comprises an image receiving component, an image processing component and a display device, and the distal end part of the injection needle and/or the injection tube is displayed on the imaging device in an imaging mode; the technical scheme has the defects that: the approach mode through the apex of the heart or the endoscope is adopted, the trauma to the patient is overlarge, the postoperative recovery is slow, the time in the operation is long, and the risk of complications is caused.

Patent CN107638615A has proposed a ventricular wall injection auxiliary instrument, include and make the banded main part that has the flexibility by biocompatible material, a plurality of locating holes distribute in the banded main part, the locating hole back sets up a plurality of vacuum chuck, form detachable between vacuum chuck and the heart surface and be connected, in order to fix the banded main part at the heart surface, operator's accessible locating hole and syringe needle inject non-contractile matter such as aquogel respectively to the different regions of ventricular wall, effectively improve injection point positioning accuracy, shorten operation time, avoid the internal residual pigment pollution of patient, however, this kind of open chest still brings the wound for the patient, clinical operation also must be troublesome, the doctor also receives the restriction in the operation in-process field of vision.

Therefore, the problems that in the prior art, operation risks caused by large wound of thoracotomy, low injection efficiency, poor injection treatment effect, easy falling of injection and the like in the clinical operation process are changed to be urgently solved at present.

Disclosure of Invention

The present application has been made in view of the above and other more general considerations.

One of the purposes of the application is to overcome the defects of the prior art, and provide a heart failure treatment system aiming at the problems of large wound of open chest surgery, low injection efficiency, poor injection treatment effect, easy falling of injection and the like in the clinical operation process.

According to another aspect of the present application, there is provided a heart failure treatment system including: the injection device comprises a control mechanism, a conveying catheter connected with the control mechanism and an injection module arranged in the conveying catheter; wherein the distal portion of the injection module has a preset configuration; and a guide positioning device disposed at least partially within the delivery catheter; when the distal end of the delivery catheter reaches the target location and the injection module is progressively extended distally from within the delivery catheter, the guiding and positioning device ensures that the distal portion of the injection module can return to the preset configuration following the predetermined path.

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

According to one embodiment, the guiding and positioning means comprises an abutment partially arranged at the distal end of the delivery catheter; a guide track is arranged in the abutting piece, so that the distal end part of the injection module can be restored to a preset shape according to a preset route.

According to an embodiment, the guiding and positioning device comprises a guiding block; wherein the guide block is arranged at the distal end region of the injection module and at the proximal side of the abutting piece, and the guide block is provided with a guide hole; and the center of the guide hole is coaxially arranged with the center of the proximal end of the guide rail.

According to an embodiment, the guiding and positioning device comprises a circumferential limiting sleeve; the circumferential limiting sleeve is sleeved on the periphery of the abutting piece and the periphery of the guide block and limits circumferential rotation of the abutting piece and the guide block.

According to an embodiment, the abutment and the guide block are of substantially polygonal configuration on their outer periphery, said abutment and said guide block being able to be embedded within said circumferential stop sleeve; the guide block can only move axially relative to the abutting piece and cannot rotate circumferentially; or, a circumferential limiting track is arranged in the circumferential limiting sleeve, and the guide block is arranged in the circumferential limiting sleeve, can axially slide relative to the abutting piece along the circumferential limiting track and cannot circumferentially rotate.

According to one embodiment, the proximal end region of the abutment is provided with a circumferential stop track along which the guide block is axially slidable and not circumferentially rotatable with respect to the abutment.

According to one embodiment, the injection module includes one or more injection needles, a withdrawal judging lumen, and an injection lumen; the injection needle is arranged at the far end of the retraction judging lumen or the injection lumen, and the retraction judging lumen and the injection lumen are arranged in parallel or are inserted and sleeved in parallel; the distal region of the withdrawal judging lumen, the distal region of the injection lumen and all the injection needles are in fluid communication, or the injection lumen and one or more injection needles form a first fluid communication channel respectively, the withdrawal judging lumen and other injection needles form a second fluid communication channel, the first fluid communication channel and the second fluid communication channel do not form fluid communication, but the distance between the needle point of the injection needle forming the first fluid communication channel and the needle point of the adjacent injection needle forming the second fluid communication channel which is restored to the preset shape is less than or equal to 10 mm; wherein the distal portion of the injection needle has a pre-set arc; and the guide track has a predetermined curvature that is substantially similar to the distal portion of the injection needle.

According to one embodiment, the injection needle is provided with a limiting structure, and a limiting slide rail is arranged in the guide hole and/or the guide track; the limiting structure can axially slide along the limiting slide rail and limit the circumferential rotation of the injection needle; the limiting structure can be a rib-shaped structure or a convex point.

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

According to one embodiment, the injection needles comprise at least 2, and all injection needles may be arranged eccentrically (non-uniformly radially distributed) and the distal portions of all injection needles may also be uniformly divergent in all directions around an axis (radially distributed).

According to another embodiment, the injection needle comprises only one needle, the distal part of the injection needle having a predetermined arc.

According to one embodiment, the portion of the injection needle penetrating into the tissue distally is called the output section, and the output section is provided with an injection hole, which is designed for the purpose of: the injection can be injected into myocardial tissue in an all-round way, and the injection efficiency and effect are improved.

According to an embodiment, the heart failure treatment system further comprises an injectate, which is preferably a myocardial injection gel.

According to one embodiment, an injection track is arranged in the control mechanism, and the recovery judgment lumen or the injection lumen or the proximal end of the injection lumen is arranged in the injection track; and the center of the injection track is coaxially arranged with the center of the abutting piece; and the recovery judging lumen or the injection lumen can only move axially relative to the abutting piece but can not rotate circumferentially.

According to an embodiment, the distal side of the guide track is provided with a leakage preventing structure; and, the leakage preventing structure is configured in a concave shape; or the far-end peripheral area of the abutting piece is provided with a deformable buffer structure, and the buffer structure does not cover the guide track; the deformable buffer structure can adapt to the shape of the myocardial tissue and can avoid the myocardial tissue from being stabbed by the abutting piece; the deformable buffer structure may have a developing type, facilitating positioning of the abutting member.

In a preferred embodiment, the number of the injection needles is 4, and when the injection module is gradually extended to the far side from the guide assembly, the 4 injection needles respectively diverge to 4 different directions so as to enlarge the radiation range of the injection and further improve the injection efficiency.

According to one 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 portion to facilitate penetration into the tissue.

According to an embodiment, the injection module has a perpendicular distance of 1-10 mm from a distally extending most distal end to the distal end of the abutment.

According to an embodiment, the injection module has a perpendicular distance of 4-6 mm from a distally extending most distal end to a distal end of the abutment.

In a preferred embodiment, the injection module has a perpendicular distance of 5mm from the distally extending most distal end to the distal end of the abutment.

According to an embodiment, the guiding and positioning means is at least partially arranged at the distal part of the delivery catheter: and the delivery catheter comprises a guide assembly and an abutment tube; when pre-assembled, the abutting tube is arranged in the guide assembly and synchronously enters the heart chamber along with the guide assembly, and the distal end of the abutting tube extends out of the guide assembly and vertically abuts against the surface of the heart muscle.

According to an embodiment, the guiding component comprises two or more bending sheaths, so that the guiding component can conform to bending at multiple positions and different angles; and, after the distal portion of the guide assembly enters the ventricle, the distal end of the abutment tube is perpendicular to the myocardial tissue surface; the purpose of this design is: a better access of the injection needle into the tissue is ensured.

According to one embodiment, the distal end of the abutment is provided with a buffer structure to protect the tissue; the cushioning structure may be an elastic material provided on the surface of the abutting member, such as: silica gel, when leaning on the piece and leaning on to organize the surface, can play effectual cushioning effect, and then the protection tissue.

According to an embodiment, the abutting part further comprises a balloon, and when the abutting part enters the heart chamber, the control mechanism is operated to flush liquid into the balloon, so that the balloon can be developed, and the positioning of the abutting part is facilitated.

According to an embodiment, the device further comprises an injection judging device; the injection judging device is arranged on the control mechanism, and liquid is distributed in the control mechanism and the injection module; when the distal end of the injection needle is pricked into the tissue, the injection judging device is pulled, and the injection judging device returns to the initial position again; when the injection needle is not penetrated into the tissue, the injection judging device is pulled, and the injection judging device does not return to the initial position again; when the injection needle reaches the target position, whether the distal end of the injection needle penetrates into the myocardial tissue can be judged by pulling the injection judging device.

According to an embodiment, the distal portion of the injection needle and/or the guide block, and the abutment are provided with a visualization function; when the guide assembly is conveyed to the target position, whether the abutting piece abuts against the target injection position or not can be judged by utilizing the developing function; and observing the relative position of the distal part of the injection needle or the guide block and the abutting piece to judge the needle-out effect of the injection needle.

According to another embodiment, the steering mechanism, the delivery catheter, the abutment, the injection module and the guiding and positioning device; wherein the abutment is disposed distally of the delivery catheter, the distal portion of the injection module having a preset configuration; and, when pre-loaded, the distal portion of the injection module is confined within the abutment; the guiding and positioning device is arranged in the conveying guide pipe; the guide positioning device ensures that the distal end portion of the injection module is returned to the preset configuration along the predetermined path when the abutment member abuts against the target location and the injection module is progressively extended distally from within the abutment member.

According to an embodiment, said abutment is provided with at least one of: the pressure sensor, the electrocardiosignal electrode, the magnetic navigation signal sensor, the optical signal sensor and the ultrasonic sensor; wherein the pressure sensor or ultrasonic sensor or optical signal sensor; can be used for detecting whether the abutting piece abuts against the target injection position; the electrocardiosignal electrode is used for collecting heart electrophysiological signals; the magnetic navigation signal sensor is used for guiding the positioning of the abutting piece.

According to an embodiment, the pressure sensor is arranged in a central region of the most distal end of the abutment; the pressure sensor can effectively transmit whether the leaning piece is clung to the tissue or not so as to judge whether the needle needs to be drawn out subsequently or not.

According to another embodiment, a heart failure treatment system includes: the device comprises a control mechanism, a guide assembly, an injection module, an injection object and an auxiliary positioning mechanism; wherein part or all of the guide assembly is disposed distal to the steering mechanism; and pre-loaded, the injection module being confined within the introducer assembly; the auxiliary positioning mechanism releases in a ventricle and guides the far side of the guide assembly to reach a target injection position, the injection module extends from the guide assembly to the far side in multiple directions gradually and restores to a preset shape, and the injectate is delivered to the positions of the multiple directions and distributed in a divergent mode through the injection module.

According to another embodiment, the secondary positioning mechanism is substantially a ring or cage like structure or a balloon like structure, and the balloon like structure is arranged at a distal region of the heart failure treatment system and assists the heart failure treatment system in performing positioning and injection.

According to another embodiment, the auxiliary positioning mechanism is a bladder structure, and the bladder structure comprises at least one of: the inside of the saccular structure can be filled with gas or liquid; the surface of the bladder-like structure has a concave, longitudinally or longitudinally staggered texture, and the distal end region of the guide assembly is nestable within the texture.

According to another embodiment, the device further comprises a guiding and positioning device; the guiding and positioning device is arranged in the conveying guide pipe; and the injection module is gradually extended to the far side from the conveying conduit, the guiding positioning device can ensure that the far end part of the injection module can return to the preset shape according to the preset route.

Compared with the prior art, the technical scheme of the application has the advantages that at least the following steps are included:

in the prior art, the operation of injecting gel into myocardial tissues of a patient only adopts a mode of opening a chest and entering, the operation time is long, the wound on the patient is large, and meanwhile, the bearing capacity of the myocardial tissues in unit area to the gel is limited, so that the injection efficiency is low; in an embodiment of the present invention, the distal portion of the injection module has a predetermined curvature, so as to effectively increase the stroke of the injection needle in the tissue and expand the radiation range of the injection needle, and meanwhile, the guiding and positioning device can ensure that the distal portion of the injection module is restored to the predetermined shape according to the predetermined route, thereby effectively preventing the injection module from deflecting and deviating from the target injection position during the needle withdrawing process.

According to one concept of the application, the injection module comprises a plurality of injection needles, and considering that the myocardial wall of a heart failure patient is thin, the distal end parts of the injection needles can uniformly disperse in all directions around an axis, and can also be eccentrically distributed, so that the injection needles can be ensured to effectively penetrate into tissues and realize treatment; meanwhile, the multiple injection needles inject gel into the myocardial tissue in a single-time, multi-direction and pertinence manner, the technical difficulty that the injection efficiency is low due to the limited gel injection bearing capacity of the myocardial tissue in unit area is overcome, the injection efficiency and the injection effect are greatly improved, the operation time is shortened, the operation success rate is improved, and the clinical significance is good.

According to one concept of the present application, the thickness of the myocardial tissue is 10-15 mm, and the injection point of the gel in the myocardial tissue is between 1/2 and 1/3 mm of the thickness of the myocardial tissue, so that the perpendicular distance from the most distal end of the injection module extending distally to the distal end of the abutting member is 3-10 mm.

According to an idea of the application, the distal part of syringe needle with lean on the piece and all possess the development function under the X-ray for but guide assembly real-time observation after getting into the ventricle leans on the piece and the position relation of target injection point, simultaneously, can judge the play needle position and the play needle effect of syringe needle through the syringe needle with the relative position who leans on the piece, the practicality is very high, has fine clinical meaning.

According to another concept of the application, the abutting piece provides a positioning function for the injection module, so that the injection module can reach a target injection position more accurately, and meanwhile, the abutting piece is also provided with a leakage-proof structure causing a concave shape, so that tissues can be gathered effectively and a leakage-proof effect is achieved; and when the injection module reaches the target position, the injection module gradually extends to a plurality of far-side directions from the inside of the guide assembly and restores to a preset shape, and gel is injected into the myocardial tissue, so that the single, multi-direction and radiation injection of the gel to the myocardial tissue is realized, the technical difficulty that the injection efficiency is low due to the limited gel injection bearing capacity of the myocardial tissue in unit area is overcome, the injection efficiency and the injection effect are greatly improved, and 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 a target injection position, and the auxiliary positioning mechanism can also provide a certain supporting force for the injection module, so as to avoid the situation that the injection module is pulled off by the outgoing line in the injection process.

According to another concept of the present application, the portion of the injection needle penetrating into the tissue distally is an output section, and the output section is provided with an injection hole, which is designed to: the injection can be injected into myocardial tissue in an all-round way, and the injection efficiency and effect are improved.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

fig. 1a to 1f are the overall structure schematic diagram of the control mechanism, the delivery catheter, the injection module, the injection object, the guiding and positioning device, the abutting piece and the injection judging device, and the needle outlet schematic diagram of the guiding needle and the injection needle of the invention.

Fig. 2 a-2 i are schematic structural diagrams of an injection module, schematic process diagrams of an injection needle penetrating into heart tissue, and schematic diagrams of a guide positioning device and an abutting piece matched with each other.

Fig. 3a to 3k are schematic structural views of the guiding and positioning device of the present invention.

Fig. 4 a-4 f are schematic views illustrating the process of injecting the injection module into the heart tissue after the abutting member abuts against the heart tissue according to the present invention.

Fig. 5 a-5 d are schematic views of the procedure of the present invention, wherein the guiding assembly passes through the femoral artery, follows the aortic arch, is bent by the first layer of bending sheath, passes through the aortic valve, reaches the left ventricle, and finally passes through the second layer of bending sheath to make the distal end of the guiding assembly vertically reach the myocardial tissue.

Fig. 6 is a schematic structural view of a delivery catheter including three bending sheaths according to the present invention.

Fig. 7 a-7 g are schematic views showing the procedure of the delivery catheter of the present invention passing through the femoral vein, then through the inferior vena cava, and then into the right atrium, then bending through the first layer of bending-adjusting sheath to pass through the interatrial septum and reach the left atrium, then bending through the second layer of bending-adjusting sheath to align with the mitral valve annulus and enter the left ventricle, and finally bending through the third layer of bending-adjusting sheath to vertically align the abutting member with the myocardial tissue.

FIGS. 8a to 8c are schematic structural views of the pressure sensor, the electrocardiosignal electrode and the magnetic navigation signal sensor of the present invention mounted on the leaning member

FIGS. 9a and 9b are schematic views of the positioning aid mechanism of the present invention assisting in delivering a catheter against a tissue surface.

Fig. 10a and 10b are schematic views showing the eccentric arrangement of the injection needle of the present invention.

Fig. 11a and 11b are schematic structural views of embodiments of a single needle of the present invention.

The figures in the drawings refer to the following features:

1-a control mechanism, 11-an injection track, 2-a delivery catheter, 21-a guide assembly, 22-an abutting pipe, 3-an injection module, 31-an injection needle, 311-an output section, 3111-an injection hole, 312-a limit structure, 32-a recovery judgment lumen, 33-an injection lumen, 34-a first fluid communication channel, 35-a second fluid communication channel, 4-an injection, 5-a guide positioning device, 51-a guide block, 511-a guide hole, 512-a guide head, 513-a ball, 52-a circumferential limit kit, 521-a slide block guide rail, 522-a ball guide rail, 6-an abutting part, 61-a guide track, 611-a leakage-proof structure, 612-a buffer structure and 62-a pressure sensor, 63-electrocardiosignal electrodes, 64-magnetic navigation signal sensors, 7-injection judgment devices, 8-auxiliary positioning mechanisms, 81-capsule structures, 811-texture structures, 82-guide structures and 9-limiting slide rails.

Detailed Description

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

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

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass 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 various 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 from the operator.

In the prior art, the operation of injecting gel into myocardial tissue of a patient only adopts a mode of opening a chest and entering, the operation time is long, the wound to the patient is large, the far side of an injection needle is straight, and the gel bearing capacity of the myocardial tissue in unit area is limited, so that the injection efficiency is low.

One of the objects of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

Example one

As shown in fig. 1a and 1b, there is illustrated a heart failure treatment system according to an embodiment of the present application, comprising: the injection device comprises a control mechanism 1, a conveying catheter 2 connected with the control mechanism 1, and an injection module 3 arranged in the conveying catheter 2; wherein the distal part of the injection module 3 has a preset configuration; and a guiding and positioning means 5, said guiding and positioning means 5 being at least partially arranged within said delivery catheter 2; when the distal end of the delivery catheter 2 reaches the target position and the injection module 3 is gradually extended distally from within the delivery catheter 2, the guiding and positioning means 5 ensures that the distal portion of the injection module 3 can return to the preset configuration following the predetermined path.

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

In the first embodiment, the guiding and positioning device 5 comprises an abutting piece 6 partially arranged at the distal end of the conveying catheter 2; a guide track 61 is provided in the abutment 6 to enable the distal portion of the injection module 3 to return to a preset configuration according to a predetermined path.

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

In the first embodiment, the guiding and positioning device 5 includes a circumferential limiting sleeve 52, as shown in fig. 3c to 3 e; the circumferential limiting sleeve 52 is sleeved on the peripheries of the abutting piece 6 and the guide block 51 and limits circumferential rotation of the abutting piece 6 and the guide block 51.

In the first embodiment, the abutting member 6 and the guide block 51 have a substantially polygonal configuration at their outer peripheries; moreover, the abutting piece 6 and the guide block 51 can be embedded in the circumferential limiting sleeve 52; alternatively, as shown in FIGS. 3 i-3 k; a circumferential limiting track 521 is arranged in the circumferential limiting sleeve 52, and the guide block 51 is arranged in the circumferential limiting sleeve 52, can axially slide along the circumferential limiting track 521 relative to the abutting piece 6 and cannot circumferentially rotate; the purpose of this design is: the guide block 51 and the abutting piece 6 are prevented from rotating in the circumferential direction, and circumferential twisting of the injection module 3 during needle withdrawing is avoided, so that the injection module can be restored to a preset shape according to a preset route.

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

In the first embodiment, as shown in fig. 3f to 3 h; the length of the circumferential stop sleeve member 52 can be lengthened, and the inner portion of the circumferential stop sleeve member 52 is configured to be substantially quadrangular as the slider guide 521, and the guide head 512 of the guide block 51 and the proximal end portion of the abutting member 6 are correspondingly configured to be substantially quadrangular so as to be embedded in the inner portion of the circumferential stop sleeve member 52, while the circumferential rotation of the guide block 51 and the abutting member 6 can be prevented.

In the first embodiment, the injection module 3 includes a plurality of injection needles 31, a recovery determination lumen 32 and an injection lumen 33, as shown in fig. 1 a; the injection needle 31 is arranged at the far end of the recovery judging lumen 32 or the injection lumen 33, and the retraction judging lumen 32 and the injection lumen 33 are arranged in parallel side by side or are sleeved in an inserting manner; the distal region of the withdrawal judging lumen 32, the distal region of the injection lumen 33 and all the injection needles 31 are in fluid communication, or the injection lumen 33 and one or more of the injection needles 31 respectively form a first fluid communication channel 34, the withdrawal judging lumen 32 and the other injection needles 31 form a second fluid communication channel 35, the first fluid communication channel 34 and the second fluid communication channel 35 do not form fluid communication, but the distance between the needle tip of the injection needle 31 forming the first fluid communication channel 34 and the needle tip of the adjacent injection needle 31 forming the second fluid communication channel 35 which is restored to the preset shape is less than or equal to 10 mm; wherein the distal portion of the injection needle 31 has a predetermined arc; and the guide track 61 has a predetermined curvature that is substantially similar to the distal portion of the injection needle 31.

In the first embodiment, the number of the injection needles 31 is 4, as shown in fig. 2a, and when the injection module 3 gradually extends to the far side from the guide mechanism 2, the 4 injection needles 31 respectively diverge to 4 different directions to expand the radiation range of injection, so as to further improve the injection efficiency, and meanwhile, the distal end portions of the 4 injection needles 31 are in a "boat anchor type" structure after penetrating into the myocardial tissue, so that the injection needles 31 can be effectively prevented from falling off from the myocardial tissue during the injection process.

In the first embodiment, the injection needle 31 is provided with a limiting structure 312, and a limiting slide rail 9 is arranged in the guide hole 511 and/or the guide rail 61; the limiting structure 312 can axially slide along the limiting slide rail 9 and limit the injection needle 31 to circumferentially rotate; the position-limiting structure 312 may be a rib-like structure or a bump.

In the first embodiment, the cross section of the injection needle 31 may be circular or irregular; for example: a triangle or a quadrangle; the cross-sectional shape of the guide hole 511 and/or the guide rail 61 matches the cross-section of the injection needle 31.

In this embodiment, the portion of the injection needle 31 penetrating into the tissue at the distal side is referred to as an output section 311, and the output section 311 is provided with an injection hole 3111, as shown in fig. 2b, which is designed to: the injection 4 can be injected into myocardial tissue in all directions, and the injection efficiency and effect are improved.

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

In this embodiment, the injectate 4 is preferably myocardial injection gel.

In the first embodiment, an injection rail 11 is disposed in the control mechanism 1, and the proximal end of the recovery judgment lumen or the injection lumen 32 is disposed in the injection rail 11; and the centre of the injection track 11 is arranged coaxially with the centre of the abutment 6; also, the recovery judging lumen or the injecting lumen 32 is axially movable relative to the abutting member 6 but not circumferentially rotatable.

In the first embodiment, a leakage-proof structure 611 is disposed at the far side of the guide rail 61; and, the leakage preventing structure 611 is configured in a concave form, as shown in fig. 2 e.

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

In this first embodiment, the distal end of the needle 31 is provided with a sharp portion to facilitate penetration into the tissue.

In this first embodiment, the perpendicular distance from the most distal end of the injection module 3 extending distally to the distal end of the abutment 6 is 5 mm.

In this first embodiment, the guiding and positioning device 5 is at least partially arranged at the distal end portion of the delivery catheter 2: and said delivery catheter 2 comprises a guide assembly 21 and an abutment tube 22; when pre-assembled, the abutment tube 22 is positioned within the guide assembly 21 and follows the guide assembly 21 into the heart chamber synchronously, and the distal end of the abutment tube 22 protrudes from the guide assembly 21 and abuts perpendicularly against the myocardial surface.

In the first embodiment, the guiding assembly 21 includes two bending sheath tubes, the guiding assembly 21 passes through the femoral artery, conforms to pass through the aortic arch, passes through the first bending sheath tube to bend and pass through the aortic valve, then reaches the left ventricle, and finally passes through the second bending sheath tube to make the distal end of the guiding assembly vertically abut against the myocardial tissue.

In the first embodiment, the distal end of the abutting member 6 is provided with a buffer structure 612 to protect the tissue; the buffer structure 612 may be an elastic material disposed on the surface of the abutting member 6, such as: silica gel, when leaning on piece 6 and leaning on the tissue surface, can play effectual cushioning effect, and then the protection tissue.

In the first embodiment, an injection judging device 7 is further included, as shown in fig. 1 e; the injection judging device 7 is arranged on the control mechanism 1, and liquid is distributed in the control mechanism 1 and the injection module 3; when the distal end of the injection needle 31 penetrates into the tissue, the injection judging device 7 is pulled, and the injection judging device 7 returns to the initial position again; when the injection needle 31 is not penetrated into the tissue, the injection judging device 7 is pulled, and the injection judging device 7 does not return to the initial position again; when the injection needle 31 reaches the target position, it is possible to judge whether or not the distal end of the injection needle 31 penetrates into the myocardial tissue by pulling the injection judging means 7.

In the first embodiment, both the distal portion of the injection needle 31 and the pressing head 6 have the function of developing under X-ray, so that the positional relationship between the pressing head 6 and the target injection point can be observed in real time after the distal portion of the delivery catheter 2 enters the ventricle, and meanwhile, the needle withdrawing position and the needle withdrawing effect of the injection needle 31 can be determined by the relative position between the distal end of the injection needle 31 and the pressing head 6.

An exemplary procedure for 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 and conveying to the left ventricle: the guiding component 21 comprises two bending-adjusting sheath tubes, the guiding component 21 passes through the femoral artery, conforms to the aortic arch, bends through the first bending-adjusting sheath tube, passes through the aortic valve, reaches the left ventricle, and finally enables the distal end of the guiding component to vertically abut against the myocardial tissue through the second bending-adjusting sheath tube, as shown in fig. 5 a-5 d;

2. injection module 3 into myocardial tissue: when the abutting member 6 abuts 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;

3. and (3) judging: pulling the injection judging device 7, if the injection judging device 7 returns to the initial position again, the distal end of the injection needle 31 is inserted into the myocardial tissue, and the next operation is continued; if the injection judging device 7 does not return to the initial position again, the injection needle 31 is withdrawn into the guide mechanism 2 according to the original route, and the target injection position is searched again;

4. injecting gel: the injected gel is delivered to multiple directional locations through four injection needles 31 and radially distributed as shown in fig. 4 a-4 d.

Example two

The second embodiment is substantially the same as the first embodiment except for the different approach.

As shown in fig. 6, there is illustrated a heart failure treatment system according to an embodiment of the present application, comprising: the device comprises a control mechanism 1, a conveying conduit 2, an injection module 3 and an injectate 4; wherein part or all of the delivery catheter 2 is disposed distal to the steering mechanism 1; and, the injection module 3 reaches the target injection site through the delivery catheter 2; when pre-loaded, 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 from the interior of the delivery catheter 2 to the distal direction and restores to the preset shape; and, the injectate 4 is delivered to multiple directional locations by the injection module 3.

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, then passes through the interatrial septum by bending-adjusting the first layer of bending-adjusting sheath to reach the left atrium, then aligns to the mitral valve annulus by bending-adjusting the second layer of bending-adjusting sheath and enters the left ventricle, and finally vertically aligns to the myocardial tissue by bending-adjusting the abutting member 6 by bending-adjusting the third layer of bending-adjusting sheath, as shown in fig. 7a to 7 g.

In a manner substantially similar to the first embodiment, when the abutting member 6 abuts against the myocardial tissue, the distal ends of the injection needles 31 protrude from the guide rails 61 of the abutting member 6 and penetrate into the myocardial tissue, and the injection gel is delivered to a plurality of directional positions through the four injection needles 31 and is distributed radially.

In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

EXAMPLE III

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

As shown in fig. 8a to 8c, there is illustrated a heart failure treatment system according to an embodiment of the present application, including: the control mechanism 1, the conveying conduit 2, the abutting piece 6, the injection module 3 and the injectate 4; wherein part or all of the delivery catheter 2 is arranged at the far side of the control mechanism 1, the delivery catheter 2 comprises two or more bending sheaths, and the abutting piece 6 is arranged at the far inner part of the innermost bending sheath; alternatively, a pressing component (not shown) is axially laid between the bending sheath and the injection module 3, and a propping piece 6 is arranged at the far end of the pressing component (not shown); and the injection module 3 reaches the target injection position through the delivery catheter 2; when pre-loaded, the injection module 3 is confined within the delivery catheter 2; wherein the distal end of the injection module 3 is positioned to the target injection site by the abutment 6 and gradually extends from the delivery catheter 2 in a plurality of distal directions and returns to the preset configuration; and, the injectate 4 is delivered to multiple directional locations by the injection module 3.

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

In the third embodiment, the abutting piece 6 is provided with at least one of the following: a pressure sensor 62, an electrocardiosignal electrode 63 and a magnetic navigation signal sensor 64; wherein said pressure sensor 62 can be used to detect whether the abutment 6 abuts against the target injection site; the electrocardiosignal electrode 63 is used for collecting heart electrophysiological signals; the magnetic navigation signal sensor 64 is used to guide the positioning of the abutment member 6.

In the third embodiment, the pressure sensor 62 is disposed in the central region of the most distal end of the abutting member 6.

In this regard, the related configuration and concept of the third embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

Example four

The fourth embodiment is substantially the same as the first embodiment except that an auxiliary positioning mechanism 8 is added.

As shown in fig. 9a and 9b, there is illustrated a heart failure treatment system according to an embodiment of the present application, comprising: the device comprises a control mechanism 1, a conveying conduit 2, an injection module 3, an injection 4 and an auxiliary positioning mechanism 8; wherein part or all of the delivery catheter 2 is disposed distal to the steering mechanism 1; and pre-loaded, the injection module 3 is confined within the delivery catheter 2; wherein the auxiliary positioning mechanism 8 releases in the ventricle and guides the far side of the delivery catheter 2 to reach the target injection position, and the injection module 3 gradually extends from the delivery catheter 2 to the far side in multiple directions and restores to the preset shape, and the injectate 4 is delivered to the positions of multiple directions and distributed divergently through the injection module 3.

In the fourth embodiment, the auxiliary positioning mechanism 8 is a ring-shaped or cage-shaped structure or a sac-shaped structure 81.

In the fourth embodiment, the auxiliary positioning mechanism 8 includes a guiding structure 82, when the delivery catheter 2 passes through a blood vessel and enters the left ventricle, the delivery catheter 2 can conform to the guiding structure 82 and extend to the target injection point, and meanwhile, during the injection process, the auxiliary positioning mechanism 8 can provide a certain supporting force for the distal end portion of the delivery catheter 2, so as to ensure the stability of the injection process, and avoid the situation that the injection needle 31 is pulled off from the outlet wire during the injection process.

In the fourth embodiment, the bladder structure 81 includes at least one of the following: the inside of the saccular structure 81 can be filled with gas or liquid, and when the inside of the saccular structure 81 is inflated, the ultrasonic equipment is matched to judge whether the delivery catheter 2 is tightly pressed against the surface of the tissue; when the bladder structure 81 is filled with liquid, it is determined whether the delivery catheter 2 is pressed against the tissue surface in cooperation with the X-ray device; the surface of the balloon-like structure 81 has a concave, longitudinally or longitudinally staggered texture 811, and the distal region of the delivery catheter 2 is recessed within the texture 811 to provide positioning and additional support for the delivery catheter 2.

In this regard, the relevant construction and concept of embodiment four is similar to embodiment one and therefore will not be repeated here.

EXAMPLE five

The fifth embodiment is substantially the same as the first embodiment, except that the injection needle 31 in the first embodiment does not uniformly disperse around an axis in all directions, but is eccentrically distributed for a certain part of a patient, so that the injection object 4 can be injected to a required target position in a targeted manner, and the effect of injection treatment is improved.

As shown in fig. 10a and 10b, there is illustrated a heart failure treatment system according to an embodiment of the present application, comprising: the device comprises a control mechanism 1, a conveying conduit 2, an injection module 3 and an injectate 4; wherein part or all of the delivery catheter 2 is disposed distal to the steering mechanism 1; and, the injection module 3 reaches the target injection site through the delivery catheter 2; when pre-loaded, 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 from the interior of the delivery catheter 2 to the distal direction and restores to the preset shape; and, the injectate 4 is delivered to multiple directional locations by the injection module 3.

In the fifth embodiment, because the myocardial wall of the heart failure patient is thin, when the distal end of the delivery catheter 2 reaches the target position, the plurality of injection needles 31 gradually extend from the interior of the delivery catheter 2 and restore to the preset shape, and the distal end portions of all the injection needles 31 are concentrated in a certain direction or a certain area, so that the fatal risk that the injection 4 blocks the coronary artery vessels or the cerebral vessels due to the fact that the injection 4 is injected into non-target areas, including the left ventricular cavity, can be effectively avoided; meanwhile, the injection treatment can be performed on a certain region more specifically, the injection efficiency and the injection effect are improved, and the injection device has good clinical significance.

In this regard, the relevant construction and concept of embodiment five is similar to embodiment one and therefore will not be repeated here.

EXAMPLE six

The sixth embodiment is substantially the same as the first embodiment except that the injection module in this embodiment consists of only a single injection needle.

As shown in fig. 11a and 11b, there is illustrated a heart failure treatment system according to an embodiment of the present application, comprising: the device comprises a control mechanism 1, a conveying conduit 2, an injection module 3 and an injectate 4; wherein part or all of the delivery catheter 2 is disposed distal to the steering mechanism 1; the injection module 3 consists of a single injection needle 31, and the injection module 3 reaches the target injection site through the delivery catheter 2; when pre-loaded, 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 returns to the preset configuration; and, the injectate 4 is delivered to the target location by the injection module 3.

In this regard, the relevant construction and concept of embodiment six is similar to embodiment one and therefore will not be repeated here.

The foregoing description of several embodiments of the application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, configurations 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 following claims.

Claims

1. A heart failure treatment system comprising:

the injection device comprises a control mechanism, a conveying catheter connected with the control mechanism and an injection module arranged in the conveying catheter;

wherein the distal portion of the injection module has a preset configuration; and

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

when the distal end of the delivery catheter reaches the target location and the injection module is progressively extended distally from within the delivery catheter, the guiding and positioning device ensures that the distal portion of the injection module can return to the preset configuration following the predetermined path.

2. The heart failure treatment system of claim 1, wherein the guide positioning device includes an abutment disposed partially at a distal end of the delivery catheter;

a guide track is arranged in the abutting piece, so that the distal end part of the injection module can be restored to a preset shape according to a preset route.

3. The heart failure treatment system of claim 2, wherein the guide positioning device comprises a guide block; wherein the guide block is arranged at the distal end region of the injection module and at the proximal side of the abutting piece, and the guide block is provided with a guide hole; and the center of the guide hole is coaxially arranged with the center of the proximal end of the guide rail.

4. The heart failure treatment system of claim 3, wherein the guide positioning device comprises a circumferential stop sleeve;

the circumferential limiting sleeve is sleeved on the periphery of the abutting piece and the periphery of the guide block and limits circumferential rotation of the abutting piece and the guide block.

5. The heart failure treatment system of claim 4, wherein the abutment and the guide block are of a generally polygonal configuration about their periphery, the abutment and the guide block being nestable within the circumferential stop sleeve; the guide block can only move axially relative to the abutting piece and cannot rotate circumferentially;

or, a circumferential limiting track is arranged in the circumferential limiting sleeve, and the guide block is arranged in the circumferential limiting sleeve, can axially slide relative to the abutting piece along the circumferential limiting track and cannot circumferentially rotate.

6. The heart failure treatment system of claim 3, wherein a proximal region of the abutment is provided with a circumferential limit track along which the guide block is axially slidable and circumferentially non-rotatable relative to the abutment.

7. The heart failure treatment system of any one of claims 1-6, wherein the injection module includes one or more injection needles, a flashback judgment lumen, and an injection lumen;

the injection needle is arranged at the far end of the retraction judging lumen or the injection lumen, and the retraction judging lumen and the injection lumen are arranged in parallel or are inserted and sleeved in parallel;

the distal region of the flashback judgment lumen, the distal region of the injection lumen, all of the injection needles are in fluid communication,

or the injection tube cavity and one or more injection needles form a first fluid communication channel respectively, the pumpback judging tube cavity and other injection needles form a second fluid communication channel, the first fluid communication channel and the second fluid communication channel do not form fluid communication, but the distance between the needle point of the injection needle forming the first fluid communication channel and the needle point of the adjacent injection needle forming the second fluid communication channel which is restored to a preset shape is less than or equal to 10 mm;

wherein the distal portion of the injection needle has a pre-set arc; and is

The guide track has a predetermined curvature that is substantially similar to the distal portion of the injection needle.

8. The heart failure treatment system of any one of claims 3-7, wherein the injection needle is provided with a limiting structure, and a limiting slide rail is arranged in the guide hole and/or the guide track; the limiting structure can axially slide along the limiting slide rail and limit the circumferential rotation of the injection needle.

9. The heart failure treatment system of claim 7, wherein an injection rail is provided within the steering mechanism, the retrieval determination lumen or the injection lumen or a proximal end of the injection lumen being provided within the injection rail;

and the center of the injection track is coaxially arranged with the center of the abutting piece;

and the recovery judging lumen or the injection lumen can only move axially relative to the abutting piece but can not rotate circumferentially.

10. The heart failure treatment system of claim 7, wherein the guide rail is distally provided with a leak-proof structure; and, the leakage preventing structure is configured in a concave shape;

alternatively, the distal peripheral region of the abutment member is provided with a deformable buffer structure which does not cover the guide track.

11. The heart failure treatment system of claim 7, wherein the distal portion of the injection needle and/or the guide block, and the abutment are provided with visualization functions;

when the conveying conduit is conveyed to a target position, whether the abutting piece abuts against the target injection position or not can be judged by utilizing a developing function; and

the relative position of the distal part of the injection needle or the guide block and the abutment member is observed to judge the needle-out effect of the injection needle.

12. The heart failure treatment system of claim 2, wherein the injection module has a perpendicular distance of 1-10 mm from a distal-most end extending distally to the distal end of the abutment.

13. The heart failure treatment system of any one of claims 1-12, wherein the guide positioning device is disposed at least partially at the distal portion of the delivery catheter: and is

The delivery catheter comprises a guide assembly and an abutting pipe fitting;

when pre-assembled, the abutting tube is arranged in the guide assembly and synchronously enters the heart chamber along with the guide assembly, and the distal end of the abutting tube extends out of the guide assembly and vertically abuts against the surface of the heart muscle.

14. The heart failure treatment system according to any one of claims 1-13, further comprising an injection judgment device; the injection judging device is arranged on the control mechanism, and liquid is distributed in the control mechanism and the injection module;

when the distal end of the injection module is punctured into the tissue, the injection judging device is pulled, and the injection judging device returns to the initial position again;

when the injection module is not penetrated into the tissue, the injection judging device is pulled, and the injection judging device does not return to the initial position again.

15. The heart failure treatment system of any one of claims 1-13, further comprising a ray-assisted judgment device; the ray auxiliary judgment device comprises a judgment liquid cavity, a ray judgment liquid and ray imaging equipment, wherein the judgment liquid cavity is axially laid in the conveying guide pipe, the distal end area of the conveying guide pipe or the abutting part is provided with a plurality of liquid outlet holes communicated with the judgment liquid cavity, and the ray judgment liquid is pre-installed in the judgment liquid cavity and can be discharged out of the system through the liquid outlet holes.

16. A heart failure treatment system comprising:

the device comprises a control mechanism, a conveying catheter, a propping piece, an injection module and a guiding and positioning device;

wherein the abutment is disposed distally of the delivery catheter, the distal portion of the injection module having a preset configuration;

and, when pre-loaded, the distal portion of the injection module is confined within the abutment; and

the guiding and positioning device is arranged in the conveying conduit;

the guide positioning device ensures that the distal end portion of the injection module is returned to the preset configuration along the predetermined path when the abutment member abuts against the target location and the injection module is progressively extended distally from within the abutment member.

17. The heart failure treatment system of claim 16, wherein the abutment is provided with at least one of:

the pressure sensor, the electrocardiosignal electrode, the magnetic navigation signal sensor, the optical signal sensor and the ultrasonic sensor;

wherein the pressure sensor or ultrasonic sensor or optical signal sensor; can be used for detecting whether the abutting piece abuts against the target injection position; the electrocardiosignal electrode is used for collecting heart electrophysiological signals; the magnetic navigation signal sensor is used for guiding the positioning of the abutting piece.

18. The heart failure treatment system of claim 17, wherein the pressure sensor is disposed in a central region of a distal-most end of the abutment.

19. A heart failure treatment system comprising: the device comprises a control mechanism, a conveying catheter, an injection module, an injection object and an auxiliary positioning mechanism; wherein the distal portion of the delivery catheter is coupled to the steering mechanism and the injection module has a preset configuration; and pre-loaded, the injection module being confined within the delivery catheter; wherein the secondary positioning mechanism releases and guides and supports the delivery catheter distally to a target injection site within a ventricle;

and, the injection module gradually extends distally from within the delivery catheter and returns to a preset configuration, the injectate being delivered to the target location through the injection module.

20. The heart failure treatment system of claim 19, wherein the secondary positioning mechanism is generally a ring or cage-like structure or a bladder-like structure;

and, the bladder structure is disposed at a distal region of the heart failure treatment system and assists the heart failure treatment system in completing positioning and injection.

21. The heart failure treatment system of claim 19, wherein the secondary positioning mechanism is a capsular structure, and wherein the capsular structure includes at least one of:

the inside of the saccular structure can be filled with gas or liquid; the surface of the balloon-like structure has a concave, longitudinally or longitudinally staggered texture, and the distal region of the delivery catheter is nestable within the texture.

22. The heart failure treatment system of any one of claims 19-21, further comprising a guide positioning device;

the guiding and positioning device is arranged in the conveying guide pipe; and is

The guiding and positioning device can ensure that the distal part of the injection module can return to the preset shape according to the preset route when the injection module extends to the far side from the conveying guide pipe step by step.