CN117653250A - Ventricular volume-reducing device - Google Patents

Abstract

The application relates to a ventricular volume-reducing device, which comprises a main body and an expandable sealing assembly, wherein the main body comprises an elastic support and a separation membrane attached to the elastic support, and the elastic support comprises a fixing part used for pointing to the apex of a left ventricle and a supporting part extending radially from the fixing part; the inflatable sealing assembly comprises a first inflatable sealing body which is arranged on the outer edge of the supporting part in a surrounding mode and is used for circumferentially abutting against the myocardial wall of the left ventricle. Compared with the prior art, the first expandable sealing body of the ventricular volume reduction device provided by the invention can form optimal fit with the irregular left ventricular myocardial wall through good expansion performance and compression retraction elastic performance, so that the ventricular volume reduction device can adapt to the irregular shape of the left ventricle, gaps are avoided to the greatest extent at the contact part with the left ventricular myocardial wall, the effect of isolating blood flow can be improved, and the blood flow entering the left ventricle of a patient can flow to the aortic valve according to a normal track and then flow to the whole body.

Description

Ventricular volume-reducing device

Technical Field

The application relates to the technical field of medical treatment, in particular to a ventricular volume reduction device.

Background

The prevalence of heart failure has increased year by year in recent years, becoming a serious public health problem. After general myocardial failure, part of left ventricular myocardium is necrotized, and heart failure symptoms such as heart enlargement, heart pumping function reduction and cardiac output reduction are caused. At present, interventional operations are mostly adopted for treating heart failure, and a heart isolation device consisting of an isolation film, a metal framework and a plastic base is implanted into the left ventricle of a patient so as to achieve the effects of reducing the volume of the left ventricle and stabilizing cardiac output.

However, the existing heart isolation device has poor sealing reliability with the left ventricle wall, and the base has insufficient fatigue resistance and stability; in the long-term beating of the heart, the mechanical properties of the stent are gradually reduced along with the time, the metal framework and the plastic base are easy to generate fatigue fracture, and the edge blood leakage and the local thrombosis are caused, so that the endothelialization time of the stent is prolonged, and the problems of structural remodeling of lesion parts, thromboembolism and the like are also easy to be caused in a long term.

Disclosure of Invention

Based on this, it is necessary to provide a ventricular volume reduction device.

A ventricular volume reduction device for reducing the volume of a left ventricle, comprising:

the main body comprises an elastic support and a separation membrane attached to the elastic support, wherein the elastic support comprises a fixing part used for pointing to the apex of the left ventricle and a supporting part extending radially from the fixing part; and

The inflatable sealing assembly comprises a first inflatable sealing body which is arranged on the outer edge of the supporting part in a surrounding mode and is used for circumferentially abutting against the myocardial wall of the left ventricle.

In one embodiment of the present invention, the elastic support includes a lumen and a plurality of cantilever beams circumferentially arranged along an axis of the lumen, the cantilever beams include a fixed end, a free end, and a cantilever arm located between the fixed end and the free end, the fixed ends of the plurality of cantilever beams are converged in the lumen to form the fixed portion, and the cantilever arms of the plurality of cantilever beams curvedly extend from the fixed end to the free end.

In one embodiment of the invention, the free end of the cantilever beam has a barb-like anchoring structure protruding from the first inflatable sealing body for anchoring connection with the myocardial wall of the left ventricle.

In one embodiment of the present invention, the cantilever of the cantilever beam is formed by sequentially connecting a plurality of arc segments.

In one embodiment of the present invention, the cross-sectional area of the cantilever beam decreases in an equal gradient from the fixed end to the free end.

In one embodiment of the present invention, the first inflatable sealing body has a plurality of recesses spaced along an outer edge, the free ends of the cantilevered beams being located in the recesses of the first inflatable sealing body.

In one embodiment of the present invention, the isolating film is attached to the upper surface and/or the lower surface of the elastic support; and/or the first expandable sealing body covers the upper surface and/or the lower surface of the elastic support.

In one embodiment of the present invention, the inflatable sealing assembly further comprises a second inflatable sealing body disposed on the fixed portion of the elastic support for abutting against the apex of the left ventricle.

In one embodiment of the present invention, the second inflatable sealing body includes a plurality of inflatable layers, and the plurality of inflatable layers are stacked at an end of the fixing portion remote from the supporting portion.

In one embodiment of the present invention, the first inflatable sealing body, the second inflatable sealing body and the isolation diaphragm are integrally fixed to the elastic support.

In one embodiment of the invention, the first inflatable sealing body is a foamed thermoplastic polyurethane or an implantable hydrogel material; and/or the second inflatable sealing body is foamed thermoplastic polyurethane or implantable hydrogel material.

In one embodiment of the invention, the first inflatable sealing body and/or the second inflatable sealing body has an open cell structure.

Compared with the prior art, the first expandable sealing body of the ventricular volume reduction device provided by the invention can form optimal fit with the irregular left ventricular myocardial wall through good expansion performance and compression retraction elastic performance, so that the ventricular volume reduction device can adapt to the irregular shape of the left ventricle, gaps are avoided to the greatest extent at the contact part with the left ventricular myocardial wall, the effect of isolating blood flow can be improved, and the blood flow entering the left ventricle of a patient can flow to the aortic valve according to a normal track and then flow to the whole body.

Drawings

In order to more clearly illustrate the technical solutions of embodiments or conventional techniques of the present application, the drawings that are required to be used in the description of the embodiments or conventional techniques will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person of ordinary skill in the art.

FIG. 1 is a schematic diagram of a first embodiment of a ventricular volume reduction device provided herein;

FIG. 2 is a schematic view of the elastic support of FIG. 1;

FIG. 3 is a schematic view of the elastic support of FIG. 2 from another perspective;

FIG. 4 is an enlarged view of the structure of the portion X in FIG. 3;

FIG. 5 is a schematic view of a portion of the structure of the elastic support of FIG. 2;

FIG. 6 is a schematic cross-sectional view of a portion of the ventricular volume-reducing device of FIG. 1;

FIG. 7 is a schematic diagram of a second embodiment of a ventricular volume reduction device provided herein;

fig. 8 is a schematic view of the structure of the left ventricle.

Reference numerals: 100. a ventricular volume reduction device; 10. a main body; 11. an elastic support; 101. a fixing part; 102. a support part; 111. a lumen; 112. a cantilever beam; 1121. a fixed end; 1122. a cantilever; 11221. a circular arc section; 1123. a free end; 11231. a barb-like anchor structure; 1124. a barrier section; 12. a separation film; 20. an inflatable seal assembly; 21. a first inflatable seal; 211. a recessed portion; 22. a second inflatable seal; 221. an expandable layer; 200. a left ventricle; 210. myocardial wall; 220. the apex of the heart.

Detailed Description

In order to make the above objects, features and advantages of the present application more comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. This application is, however, susceptible of embodiment in many other forms than those described herein and similar modifications can be made by those skilled in the art without departing from the spirit of the application, and therefore the application is not to be limited to the specific embodiments disclosed below.

It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When a component is considered to be "connected" to another component, it can be directly connected to the other component or intervening components may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used in the description of the present application for purposes of illustration only and do not represent the only embodiment.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the meaning of "plurality" is at least two, such as two, three, etc., unless explicitly defined otherwise.

In this application, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be a direct contact of the first feature with the second feature, or an indirect contact of the first feature with the second feature via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely under the second feature, or simply indicating that the first feature is less level than the second feature.

Unless defined otherwise, all technical and scientific terms used in the specification of this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. The term "and/or" as used in the specification of this application includes any and all combinations of one or more of the associated listed items.

Conventional cardiac isolation devices suffer from a number of drawbacks. On one hand, the existing heart isolation device is connected with the ventricular wall only through circumferential barb anchoring and myocardial wall, so that the sealing fit is poor; in the long-term beating of the heart, the support is easy to deform and shift or break and lose efficacy, so that blood is leaked into the lesion part of the ventricle through the contact edge part of the device and the ventricle wall, and the lesion part is easy to be caused to expand outwards. On the other hand, the existing heart isolation device has poor stability of a base after being implanted into the left ventricle, cannot resist the torsion movement of the heart, and easily causes the displacement and fracture problems of the device along with the contraction movement of the heart.

Based on this, the present application provides a ventricular volume reduction device 100 for use in the medical field.

Referring to fig. 1 and 8, fig. 1 is a schematic structural view of a first embodiment of a ventricular volume reduction device 100 provided in the present application; fig. 8 is a schematic diagram of the structure of the left ventricle 200.

In a first embodiment of the present invention, the ventricular volume-reducing device 100 comprises a main body 10 and an inflatable sealing assembly 20, wherein the main body 10 comprises an elastic support 11 and a separation membrane 12 attached to the elastic support 11, and the elastic support 11 comprises a fixing portion 101 for pointing to the apex 220 of the left ventricle 200 and a supporting portion 102 extending radially from the fixing portion 101; the inflatable sealing assembly 20 comprises a first inflatable sealing body 21 arranged around the outer edge of the support 102, the first inflatable sealing body 21 being adapted to circumferentially abut against the myocardial wall 210 of the left ventricle 200.

After the ventricular volume-reducing device 100 provided by the invention is implanted into the left ventricle 200 of a patient, the first inflatable sealing body 21 can form optimal fit with the myocardial wall 210 of the left ventricle 200 of the patient through the inflation performance and the compression rebound resilience, so that the ventricular volume-reducing device 100 can adapt to the shape of the myocardial wall 210 of the left ventricle 200, gaps are avoided to the greatest extent on the contact part with the myocardial wall 210 of the left ventricle 200, the effect of isolating blood flow of the ventricular volume-reducing device 100 is improved, and blood flow entering the left ventricle 200 of the patient can flow to the aortic valve according to a normal track and then flow to the whole body. At the same time, the expansion of the first inflatable sealing body 21 can provide a lateral holding force to the myocardial wall 210 of the left ventricle 200, so that the ventricular volume-reducing device 100 can be stably placed in the left ventricle 200, and the instrument shape can be well maintained when the blood flow from the mitral valve impacts the proximal surface of the ventricular volume-reducing device 100.

Referring to fig. 2 and 3, fig. 2 is a schematic structural view of the elastic support 11 in fig. 1; fig. 3 is a schematic structural view of the elastic support 11 in fig. 2 from another view.

Preferably, in the present embodiment, the elastic support 11 includes a lumen 111 and a plurality of cantilever beams 112 circumferentially arranged along an axis of the lumen 111, the cantilever beams 112 include a fixed end 1121, a free end 1123, and a cantilever 1122 between the fixed end 1121 and the free end 1123, the fixed end 1121 of the plurality of cantilever beams 112 is converged in the lumen 111 to form the fixed portion 101, and the cantilever 1122 of the plurality of cantilever beams 112 extends from the fixed end 1121 to the free end 1123 in a bending manner.

So set up, elastic support 11 adopts the structural design of many cantilever beams 112, can effectively reduce the problem of support structure stress concentration at the room deformation in-process of following heart, improves the holistic fatigue resistance of support, keeps the stability of apparatus overall structure, prolongs the life of ventricular volume reduction device 100 by a wide margin. It is understood that, in the present embodiment, the fixing portion 101 of the elastic support 11 refers to the fixed end 1121 and the lumen 111 of the cantilever beam 112, and the supporting portion 102 of the elastic support 11 refers to the cantilever 1122 and the free end 1123 of the cantilever beam 112.

Preferably, the fixed ends 1121 of adjacent cantilevered beams 112 may also be connected in sequence by arcuate connecting segments to enhance fatigue resistance at the lumen 111 of the elastic stent 11.

Further, in the present application, the plurality of cantilever beams 112 are preferably uniformly arranged in an equal gap manner, and it is understood that in other embodiments, the gaps between the plurality of cantilever beams 112 may be unequal, and the specific arrangement manner and the gap width are not limited herein.

It will be appreciated that the cantilever beams 112 may have equal lengths or may be alternatively arranged with a certain length difference, so as to improve the stability of the elastic support 11. Preferably, in this embodiment, the length of each cantilever beam 112 is equal.

Referring to fig. 1 again, and referring to fig. 4 and 5 together, fig. 4 is an enlarged schematic view of the portion X in fig. 3; fig. 5 is a schematic view of a part of the structure of the elastic support 11 in fig. 2.

Further, the free end 1123 of the cantilever beam 112 has a barb-like anchoring structure 11231, the barb-like anchoring structure 11231 protruding beyond the first inflatable sealing body 21 for anchoring connection with the myocardial wall 210 of the left ventricle 200 to improve the reliability of the connection of the ventricular volume-reducing device 100 with the myocardial wall 210 of the left ventricle 200; in other words, the provision of the barb-like anchoring structures 11231 in this manner can further enhance the placement stability of the ventricular volume-reduction device 100 in the left ventricle 200 in cooperation with the first inflatable sealing body 21 under the strong abutment of the first inflatable sealing body 21 with the peripheral side myocardial wall 210 of the left ventricle 200.

Further, in this embodiment, preferably, the cantilever beam 112 further has a baffle 1124 protruding near the barb-like anchoring structure 11231, and the baffle 1124 has a cross-sectional area larger than that of the cantilever 1122 and the free end 1123, so as to limit the penetration depth of the barb-like anchoring structure 11231 into the myocardial wall 210, and avoid damage to the patient.

Referring to fig. 3 and 4 again, in order to make the elastic support 11 better adapt to the long-term beating torsion of the heart, it is preferable that the cantilever 1122 of the cantilever beam 112 is formed by sequentially connecting a plurality of arc segments 11221 in this embodiment. So set up, the cantilever 1122 surface bending stress distribution that a plurality of circular arc sections 11221 connect gradually forms can be more even, makes it can be more smooth and easy crooked, makes cantilever 112 possess better crooked resilience when guaranteeing cantilever 112 holding power, makes elastic support 11 can be in heart long-term beat, the ventricle is deformation in-process is repeated and is kept reliable and stable supporting effect all the time.

Referring again to fig. 5, in this embodiment, the cross-sectional area of the cantilever 112 preferably decreases in an equal gradient from the fixed end 1121 to the free end 1123. By the arrangement, the stress concentration problem of the elastic support 11 can be further reduced, the risk of fracture caused by the stress concentration of the cantilever beam 112 is reduced, the long-term fatigue resistance of the cantilever beam 112 is further enhanced, the holding volume of the free end of the cantilever beam 112 can be reduced, and the difficulty of interventional operation and the burden on the heart of a patient are correspondingly reduced.

Referring to fig. 1 again, and referring to fig. 6 together, fig. 6 is a schematic cross-sectional view of a portion of the ventricular volume-reducing device 100 in fig. 1. Further, in the present embodiment, the inflatable sealing assembly 20 further includes a second inflatable sealing body 22, and the second inflatable sealing body 22 is disposed on the fixing portion 101 of the elastic support 11 and is used for abutting against the apex 220 of the left ventricle 200. So set up, the second inflatable sealing body 22 can be inflated rapidly after the ventricular volume reduction device 100 enters the left ventricle 200, and the second inflatable sealing body is gently abutted with the apex 220 of the left ventricle 200, so that a doctor can conveniently position and fix the ventricular volume reduction device 100 in the operation process, the myocardial wall 210 is prevented from being punctured, and the damage to a patient is reduced.

In this application, the first and second inflatable seals 21, 22 may be made using a suitable matrix of biocompatible polymer or crosslinkable prepolymer blended with one or more blowing agents, including but not limited to foamed thermoplastic polyurethane (foamed TPU material), implantable hydrogels, or sponges, and the like.

Preferably, in the present embodiment, the first expandable sealing body 21 and the second expandable sealing body 22 are both foamed thermoplastic polyurethane (foamed TPU material), and the materials have light weight, high resilience and high compressibility, and good biocompatibility, so that the first expandable sealing body 21 and the second expandable sealing body 22 can be quickly (within a few minutes) expanded to be closely attached to the myocardial wall 210 of the left ventricle 200 after entering the left ventricle 200, and the cyclic stress resistance of the materials can be well adapted to the high-frequency contraction beat of the heart, so that the first expandable sealing body 21 and the second expandable sealing body 22 are always kept in stable and tight abutment with the myocardial wall 210 of the left ventricle 200. In addition, the expansion of the material is reversible, so that a doctor can realize the repeated retraction and release of the ventricular volume reduction device 100, and the operation difficulty is reduced.

It is understood that in other embodiments, the first inflatable sealing body 21 and the second inflatable sealing body 22 may also be both implantable hydrogel materials, including but not limited to alginate hydrogels, polyvinyl alcohol (PVA), polyacrylic acid and derivatives thereof, polyethylene glycol (PEG) derivatives, and the like. So long as the first inflatable sealing body 21 and the second inflatable sealing body 22 can both be sealed and attached to the irregular left ventricle wall under the premise of not affecting the body of the patient and effectively blocking blood flow. It is worth mentioning that the hydrogel material requires the dried hydrogel particles to be encapsulated in a barrier film, and the full expansion of the volume can be achieved within a few minutes by hydrating the dried hydrogel particles with biological fluid during surgery.

It will be appreciated that in other embodiments, one of the first and second inflatable seals 21, 22 may be a foamed thermoplastic polyurethane material and the other an implantable hydrogel material, as long as the function of the ventricular volume reduction device 100 is not affected.

Preferably, in the present embodiment, the first expandable seal 21 and the second expandable seal 22 contain contrast agents, radiopaque additives, which may be (but are not limited to) micro-or nano-sized particles; it is possible to realize that the first inflatable sealing body 21 and the second inflatable sealing body 22 are released during the transportation by means of fluoroscopy or by means of X-ray analysis.

Preferably, in the present embodiment, the first expandable sealing body 21 and the second expandable sealing body 22 each have an open-cell structure (not shown), and the first expandable sealing body 21 and the second expandable sealing body 22 are each capable of allowing at least 10-fold and up to 60-fold volumetric expansion from an unexpanded state to an expanded state. Specifically, the foaming material with the open-cell structure is internally provided with a plurality of cells, the cells can be communicated with each other, gas or micromolecular liquid can be permeated, the foaming material has excellent compressibility, can be compressed in a low-stress state, and can be well suitable for the contraction and torsion movements of the heart; meanwhile, the cell structure can reduce the difficulty of endothelial cell climbing of the myocardial wall and accelerate endothelialization time; wherein the degree of compressibility is related to the pore size of the cells, which may be selected according to the requirements. In addition, the foam material with the open-cell structure is easy to rebound and recover, the rebound force is small, and after being compressed by ventricular deformation, the foam material can rebound rapidly and always keep a moderate and tight abutting with the myocardial wall 210. Because the internal pore bubble structure is complex, the open pore structure also has excellent water stopping and retaining effects, and the water is not easy to leak and run off after being compressed.

It will be appreciated that in other embodiments, the first and second inflatable seals 21, 22 may also be closed cell structures or a combination of open and closed cell structures. Wherein, the inside of the foam material with a closed-cell structure is provided with independent cells, wall films are arranged between the inner cells and the cells and are not mutually communicated, and the foam material with a closed-cell structure also has excellent impact resistance, reverse elasticity, softness and toughness, and can also ensure that the first expandable sealing body 21 is tightly attached to the myocardial wall 210 of the left ventricle 200 and effectively blocks blood.

Referring again to fig. 6, in a first embodiment of the present application, preferably, the first expandable sealing body 21 is an annular expandable body, and the second expandable sealing body 22 includes a plurality of expandable layers 221, the plurality of expandable layers 221 being stacked at an end of the fixing portion 101 remote from the supporting portion 102, and in particular, the plurality of expandable layers 221 being stacked at an end of the lumen 111 remote from the cantilever beam 112. Specifically, each of the expandable layers 221 has cells (not shown) of different pore sizes so that the compressible amount of each of the expandable layers 221 is different. In this way, the ventricular volume-reducing device 100 can be adjusted in a telescopic manner according to the stress condition, so that a doctor can conveniently adjust the distance between the elastic support 11 and the apex 220 of the left ventricle 200 in the operation process, and the ventricular volume-reducing device 100 can be fixed at the most suitable position according to the heart condition of different patients.

Preferably, in the present embodiment, the plurality of expandable layers 221 are integrally formed, which facilitates manufacturing while reducing the difficulty in securing the second expandable sealing body 22.

Preferably, in the present embodiment, the larger the cell aperture within the expandable layer 221 closer to the apex 220, i.e., the more the expandable layer 221 closer to the apex 220 is compressible, the longer the distance that the ventricular volume reduction device 100 can be telescopically adjusted.

Preferably, in the present embodiment, the first inflatable sealing body 21, the second inflatable sealing body 22 and the isolation diaphragm 12 are integrally attached to the elastic support 11. By such arrangement, the reliability of blocking blood flow of the ventricular volume-reducing device 100 can be increased, gaps or holes are avoided among the first expandable sealing body 21, the second expandable sealing body 22 and the isolating membrane 12, and blood from the mitral valve can flow to the aortic valve according to a normal track after being blocked by the ventricular volume-reducing device 100, and then flows to the whole body.

It will be appreciated that in other embodiments, the first inflatable sealing body 21, the second inflatable sealing body 22, and the isolation diaphragm 12 may be separately formed and then secured to the elastic support 11. Alternatively, the first expandable sealing member 21, the second expandable sealing member 22, and the separation membrane 12 may be partially integrally formed and partially detachably formed and then fixed to the elastic support 11, so long as the ventricular volume-reduction device 100 can effectively perform the function of reducing volume and blocking blood flow. It will be appreciated that the first inflatable sealing body 21, the second inflatable sealing body 22, and the barrier film 12 may be affixed to the elastic support 11 by means including, but not limited to, stitching, fusion, adhesive, welding, etc.

Preferably, in the present embodiment, the separation film 12 is conformally attached to the upper and lower surfaces of the elastic support 11. By doing so, the reliability of the blood flow blocking by the isolation film 12 can be ensured. Further, in order to improve the choke-blocking effect and the holding force of the first expandable sealing body 21, in the present application, the first expandable sealing body 21 covers the upper surface and the lower surface of the elastic support 11. It will be appreciated that in other embodiments, the isolation diaphragm 12 and the first inflatable sealing body 21 may be disposed only on the upper or lower surface of the elastic support 11, as long as the barrier effect on blood is not affected.

Referring again to fig. 6, preferably, in this embodiment, a second inflatable seal 22 is disposed between lumen 111 and isolation diaphragm 12; the lower surface of the second inflatable sealing body 22 is fixedly connected with the inner surface of the isolating membrane 12 to form a disc-shaped structure; the upper surface of the second inflatable sealing body 22 is fixedly connected with the lumen 111 or in contact connection after inflation; it will be appreciated that in other embodiments, the second inflatable seal 22 may be disposed outside of the isolation diaphragm 12; specifically, the second expandable sealing member 22 may be selectively disposed according to the material state of the second expandable sealing member, for example, the dry hydrogel particles need to be disposed in the separator 12, so as to ensure the hydrated molding; for example, a foam-like molding material may be provided on both the inner and outer surfaces of the separator 12.

It should be emphasized that the isolation diaphragm 12 is attached to the surface of the elastic support 11, rather than being attached to the surface of the cantilever beams 112 alone, in other words, the surface of the support structure formed by the plurality of cantilever beams 112 is fully provided with the isolation diaphragm 12, so that the isolation diaphragm 12 can form an effective blocking surface in cooperation with the first expandable sealing body 21 at the proximal end of the ventricular volume-reducing device 100. Thus, after the ventricular volume-reduction device 100 is implanted in the left ventricle 200 of the patient, the blood flow from the mitral valve will be blocked by the blocking surface formed by the isolation membrane 12 and the first inflatable sealing body 21, so that the blood flow can be pumped into the main valve along with the beating of the heart according to the normal track, and then flows to the whole body; in other words, the barrier surface formed by the isolation diaphragm 12 and the first inflatable sealing body 21 can effectively reduce the volume of the left ventricle 200, and prevent blood flow from entering the lower region of the left ventricle 200, so as to ensure that the blood can be normally discharged along with the beating of the heart, and the heart displacement is stabilized.

Preferably, in this embodiment, the separator 12 is a thin film structure made of tetrafluoroethylene (ePTFE) material. Further, the separation membrane 12 has a microporous structure that allows permeation of small molecular substances while effectively blocking blood, so as to allow hydration expansion of the dry hydrogel materials in the first and second expandable sealing bodies 21 and 22 while isolating the surface of the elastic stent 11 from the outside.

Preferably, in the present embodiment, the elastic support 11 is a memory metal skeleton made of nickel titanium (NiTi) alloy, and it is understood that in other embodiments, the elastic support 11 may be made of other memory alloys having super elasticity, which is not listed herein.

It will be appreciated that referring to fig. 1 and 6, in the present embodiment, the isolation diaphragm 12 and the second inflatable sealing body 22 form a base structure, and when the distal end of the ventricular volume reduction device 100, i.e., the base, is released into the left ventricle 200, the second inflatable sealing body 22 and the isolation diaphragm 12 can contact the apex 220 of the left ventricle 200, thereby avoiding the ventricular volume reduction device 100 from puncturing the left ventricle wall after implantation into the left ventricle 200 and reducing damage to the patient.

In other words, in the present embodiment, the first inflatable sealing body 21 and the isolation membrane 12 are used to isolate the dynamic chamber and the static chamber, so as to ensure normal and stable blood flow and blood flow direction; the second inflatable sealing body 22 is adapted to cooperate with the barb-like anchoring structures 11231 and the first inflatable sealing body 21 to support the elastic support 11 in a stable position.

In the present embodiment, the elastic support 11 is used to restrict the folding and unfolding of the isolation diaphragm 12 in a specific configuration, and to restrict the expansion and contraction of the first and second inflatable sealing bodies 21 and 22 at the outer edge of the support 102 and at the lumen 111. In other words, the elastic stent 11 has a contracted state when introduced into the left ventricle 200 and a released state after introduced into the left ventricle 200.

In this embodiment, the elastic stent 11 in the contracted state and the first and second expandable sealing bodies 21 and 22 in the unexpanded state can be compressed into a delivery catheter within 14fFr (14 fFr guide tube inner diameter size is about 4.67 mm) for smooth introduction into the left ventricle 200 by interventional procedures, which are specifically described as follows:

when the elastic support 11 is in the contracted state, the ventricular volume-reducing device 100 can be delivered to the apex 220 of the left ventricle 200 via the femoral artery, the aorta, and the aortic valve along the arterial vascular path via the delivery catheter used in the interventional procedure. Specifically, after the ventricular volume-reducing device 100 is assembled with the distal end of the delivery rod outside the body, the delivery rod pushes the ventricular volume-reducing device 100 to the apex 220 of the left ventricle 200 along the delivery catheter, the delivery rod is fixed, the delivery catheter is retracted to release the distal end of the ventricular volume-reducing device 100 at the apex 220 of the left ventricle 200, that is, one end of the second expandable sealing body 22 is provided, and simultaneously the second expandable sealing body 22 begins to expand rapidly, so as to complete positioning support. Continuing to withdraw the delivery catheter until the ventricular volume-reduction device 100 exits the catheter, and expanding the elastic support 11 through the balloon at the end of the delivery catheter; at this time, the elastic support 11 is converted from the contracted state to the released state, when the elastic support 11 is in the released state, the plurality of cantilever beams 112 are unfolded to form an inverted umbrella-shaped structure, and the barb-shaped anchoring structures 11231 at the free ends 1123 of the plurality of cantilever beams 112 penetrate into the myocardial wall 210 of the left ventricle 200 to realize the Zhou Xiangmao connection with the myocardial wall 210 of the left ventricle 200; simultaneously, the first expandable sealing body 21 starts to expand continuously and gradually and tightly clings to the myocardial wall 210 of the left ventricle 200, so that the blood blocking effect of the ventricular volume reduction device 100 is more stable and reliable; and during the heart beat torsion process, the first expandable sealing body 21 can be compressed and rebounded adaptively, and can keep close fit with the myocardial wall 210 of the left ventricle 200 all the time, so that the possibility of leakage blood from gaps at the contact part with the myocardial wall 210 of the left ventricle 200 is avoided.

Compared with the prior art, the first expandable sealing body 21, the elastic support 11 and the second expandable sealing body 22 of the ventricular volume reduction device 100 provided by the invention are a complete elastic deformation body, so that the force applied to the left ventricular wall when the elastic deformation body contacts the left ventricular wall is relatively uniform and mild, and the phenomena of perforation and conduction bundle blocking of the myocardial wall of the left ventricle 200 caused by stress concentration can be effectively reduced or avoided.

Referring to fig. 7, fig. 7 is a schematic structural diagram of a second embodiment of a ventricular volume-reduction device 100 provided in the present application; the present invention also provides a second embodiment, which is identical in concept and most of its structure to the first embodiment, except that in the second embodiment of the present invention, the first inflatable sealing body 21 has a plurality of concave portions 211 spaced along the outer edge, and the free ends 1123 of the cantilever beams 112 are located in the concave portions 211 of the first inflatable sealing body 21. Because the myocardial wall 210 generally has multiple layers of folds, the free end 1123 of the cantilever beam 112 is disposed in the concave portion 211, so that the barb-shaped anchoring structure at the free end 1123 can stretch the folds on the myocardial wall 210 towards the concave portion of the first expandable sealing body 21, so that the first expandable sealing body 21 protruding between the adjacent free ends 1123 can be tightly attached to the myocardial wall 210, and the two can be matched with each other to enable the ventricular volume-reducing device 100 to be tightly attached to the folded myocardial wall 210, so that the attachment and the sealing performance between the first expandable sealing body 21 and the myocardial wall 210 are improved, and the flow blocking effect of the ventricular volume-reducing device 100 is further ensured.

In other words, in the second embodiment of the present invention, the first inflatable sealing body 21 includes an annular portion and a lace-shaped structure disposed around the periphery of the annular portion, that is, a portion of the first inflatable sealing body 21 protruding between the free ends 1123 of the two adjacent cantilever beams 112, it will be appreciated that, in other embodiments, the shape of the first inflatable sealing body 21 may be changed accordingly, as long as the first inflatable sealing body 21 can be kept tightly adhered to the myocardial wall 210.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the claims. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of the present application is to be determined by the following claims.

Claims (12)

1. A ventricular volume reduction device for reducing the volume of a left ventricle, comprising:

the main body comprises an elastic support and a separation membrane attached to the elastic support, wherein the elastic support comprises a fixing part used for pointing to the apex of the left ventricle and a supporting part extending radially from the fixing part; and

The inflatable sealing assembly comprises a first inflatable sealing body which is arranged on the outer edge of the supporting part in a surrounding mode and is used for circumferentially abutting against the myocardial wall of the left ventricle.

2. The ventricular volume reduction device of claim 1, wherein the elastic support comprises a lumen and a plurality of cantilever beams circumferentially arranged along an axis of the lumen, the cantilever beams comprising a fixed end, a free end, and a cantilever arm positioned between the fixed end and the free end, the fixed ends of the plurality of cantilever beams converging at the lumen to form the fixed portion, the cantilever arms of the plurality of cantilever beams extending curvedly from the fixed end to the free end.

3. The ventricular volume reduction device of claim 2, wherein the free end of the cantilever beam has a barb-like anchoring structure protruding from the first expandable sealing body for anchoring connection with a myocardial wall of the left ventricle.

4. A ventricular volume reduction device as claimed in claim 3 wherein the cantilever of the cantilever beam is formed of a plurality of arcuate segments connected in sequence.

5. The ventricular volume reduction device of claim 4, wherein a cross-sectional area of the cantilever beam decreases isocratically from the fixed end to the free end.

6. The ventricular volume reduction device of claim 3 wherein the first inflatable sealing body has a plurality of recesses spaced along an outer edge, the free end of the cantilever beam being located in the recess of the first inflatable sealing body.

7. The ventricular volume reduction device of claim 1, wherein the isolation membrane is attached to an upper surface and/or a lower surface of the elastic support; and/or the number of the groups of groups,

the first expandable sealing body covers the upper surface and/or the lower surface of the elastic support.

8. The ventricular volume reduction device of any one of claims 1-7, wherein the inflatable sealing assembly further comprises a second inflatable sealing body disposed at the fixation portion of the elastic support for abutting the apex of the left ventricle.

9. The ventricular volume reduction device of claim 8, wherein the second expandable seal comprises a plurality of expandable layers, the plurality of expandable layers being layered at an end of the fixation portion remote from the support portion.

10. The ventricular volume reduction device of claim 8, wherein the first inflatable sealing body, the second inflatable sealing body, and the isolation diaphragm are integrally secured to the elastic support.

11. The ventricular volume reduction device of claim 8, wherein the first expandable seal is a foamed thermoplastic polyurethane or an implantable hydrogel material; and/or the number of the groups of groups,

the second inflatable sealing body is foamed thermoplastic polyurethane or an implantable hydrogel material.

12. The ventricular volume reduction device of claim 11, wherein the first expandable seal and/or the second expandable seal has an open-cell structure.