Auxiliary ventricular compression device

Abstract

The invention provides a ventricle auxiliary pressing device which comprises an inner layer structure, an outer layer structure and a pressing unit, and the outer layer structure is arranged outside the inner layer structure in a sleeving mode; a cavity is formed between the inner layer structure and the outer layer structure, and the pressing unit is movably arranged in the cavity; the auxiliary ventricular compression device at least has a compression state and a release state; in the release state, the inner layer structure is used for wrapping part of the outer surface of a preset object, the pressing unit is used for alternately expanding and contracting, the pressing unit presses the preset object when expanding, and the pressing unit can be moved out of the cavity. The pressing unit of the device can be taken out from the position between the inner layer structure and the outer layer structure, so that retention materials of the device in the body can be reduced after the device fails, the influence of the retention materials on the heart of a patient is relieved, or the influence on intervention of other subsequent heart treatment means is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a ventricular assist compression device. Background Art

[0002] Current ventricular assist devices usually use pulsatile pumps, axial flow pumps or centrifugal pumps to directly work on the blood flow to increase the blood flow rate and pressure, thereby assisting the left ventricle or right ventricle in working. The above-mentioned ventricular assist devices all have components (such as pump housing, impeller, blood inflow or outflow pipes, etc.) that are in direct contact with the blood; in addition, since the impeller will output driving force to the blood after contact with the blood, this process is prone to blood compatibility risks such as coagulation or hemolysis, and may cause peripheral arterial thrombosis, visceral bleeding and other problems in patients after the implantation of the ventricular assist device, and in severe cases, it may cause adverse events such as patient death.

[0003] In recent years, many companies and research institutions have developed non-blood direct contact ventricular assist devices. The most common non-blood direct contact ventricular assist devices currently provide the heart with auxiliary power for blood ejection by periodically pressing the heart. Since this type of device does not come into direct contact with the blood, it can effectively avoid blood compatibility risks. In addition, the implantation of this type of device does not require puncture at the apex of the heart, will not cause permanent damage to the myocardial tissue, is more conducive to the recovery of heart function in patients with heart failure, and is conducive to early treatment of the disease and improving the long-term survival rate of patients.

[0004] The common non-blood direct contact ventricular assist device at present is a kind of bag that can be set on the outer wall of the heart, and there are multiple inflatable airbags in the bag, and the multiple inflatable airbags are connected to the corresponding extracorporeal gas pipelines. When the device is used, the airbags can be inflated and deflated to achieve the expansion and contraction of the airbags, thereby giving the heart contraction power and assisting the natural heart to pump blood to the whole body. For the existing ventricular assist device, the multiple airbags in the bag are designed as one body, and a single airbag cannot move independently. When a single inflatable airbag is damaged or blocked, it is impossible to remove or replace the single airbag from the bag, resulting in a decrease in the working capacity of the ventricular assist device. In addition, due to the long-term implantation of the bag, the surface of the bag that contacts the heart undergoes endothelialization (that is, the bag is embedded in the outer wall tissue of the heart), making it difficult to remove the bag, and the integrated airbag is also difficult to remove in the bag, so that the entire device faces the risk of failure, which is easy to affect the normal work of the heart and may also cause the patient's condition to worsen. Summary of the invention

[0005] The object of the present invention is to provide a ventricular assist compression device, the compression unit of which can be taken out from between the inner structure and the outer structure, so as to reduce the retained material of the device in the body after the device fails, thereby reducing the impact of the retained material on the patient's cardiac work.

[0006] To achieve the above-mentioned purpose, the present invention provides a ventricular assist pressing device, comprising an inner layer structure, an outer layer structure and a pressing unit, wherein the outer layer structure is sleeved on the outside of the inner layer structure; a cavity is provided between the inner layer structure and the outer layer structure, and the pressing unit is used to be movably provided in the cavity; the ventricular assist pressing device has at least a compressed state and a released state; in the released state, the inner layer structure is used to cover at least a portion of the outer surface of a predetermined object, and the pressing unit is used to alternately expand and contract, and the pressing unit presses the predetermined object when expanded, and the pressing unit can also be moved out of the cavity.

[0007] Optionally, a fixing part is provided on the outer surface of the inner layer structure facing the pressing unit, and the pressing unit is connected to the inner layer structure via the fixing part to prevent the pressing unit from moving relative to the inner layer structure; when the pressing unit is subjected to a force from the distal end toward the proximal end in the axial direction of the inner layer structure, the pressing unit is separated from the inner layer structure and can be moved out of the cavity.

[0008] Optionally, the fixing member is a limiting plate, and there are multiple fixing members, which together enclose a first accommodating cavity having a first opening; the pressing unit is used to enter from the first opening and be limited in the first accommodating cavity, and the pressing unit is also used to move out of the first accommodating cavity from the first opening.

[0009] Optionally, the fixing member has one of a convex portion and a concave portion, and the other of the convex portion and the concave portion is provided on the pressing unit, and the convex portion is used to cooperate with the concave portion so that the inner layer structure is connected to the pressing unit; the convex portion is also used to deform and release the cooperation with the concave portion after the pressing unit is subjected to a force acting from the distal end toward the proximal end in the axial direction of the inner layer structure.

[0010] Optionally, the inner layer structure and the outer layer structure are sewn together to form a pressing line, and the pressing line encloses a second accommodating cavity having a second opening; the pressing unit is used to enter from the second opening and be limited in the second accommodating cavity, and the pressing unit is also used to move out of the second accommodating cavity from the second opening.

[0011] Optionally, the pressing unit is fixedly connected to the inner layer structure via a degradable material; the degradable material can degrade after the pressing unit is implanted in the body, so as to separate the pressing unit from the inner layer structure.

[0012] Optionally, at least one of the inner layer structure and the outer layer structure is composed of at least one layer of polymer film.

[0013] Optionally, the pressing unit includes a bag and a fluid pipeline, the bag is placed in the cavity, and the fluid pipeline is connected to the bag; the fluid pipeline is used to inject or extract a working medium into the bag; the bag is used to expand after the working medium is injected, and to shrink after the working medium is extracted; after the bag is expanded, it can apply pressing force to the predetermined object.

[0014] Optionally, the ventricular assist compression device further includes a fixing ring, which is sleeved on the outside of the fluid pipeline and connected to the fluid pipeline.

[0015] Optionally, the ventricular assist compression device also includes a support structure, which is used to be placed between the inner layer structure and the outer layer structure. The support structure can be compressed by external force and can automatically expand after the external force is removed; after the support structure expands, it can drive the inner layer structure and the outer layer structure to release.

[0016] Optionally, the support structure is a metal woven mesh or a metal cutting bracket, and the support structure is arranged between the pressing unit and the outer layer structure, and the support structure is used to reduce the displacement of the pressing unit toward the outer layer structure when the pressing unit expands.

[0017] Optionally, the ventricular assist compression device further includes a fixing ring, and the fluid pipeline of the compression unit is connected to the fixing ring; the support structure is connected to the fixing ring; and the compression unit is used to drive the support structure to move through the fixing ring.

[0018] Optionally, the ventricular assist compression device also includes a first delivery pipeline and a second delivery pipeline. In the compressed state, the inner layer structure, the outer layer structure and the compression unit are all compressed in the first delivery pipeline and implanted into the human body; the support structure is arranged between the compression unit and the outer layer structure, and the second delivery pipeline is connected to the support structure; after the inner layer structure covers the predetermined object, the support structure is moved out of the cavity under the drive of the second delivery pipeline.

[0019] Optionally, at least part of the outer surface of the inner layer structure is covered with a film, and there is a gap between the film and the inner layer structure; the ventricular assist compression device also includes a glue injection pipeline, which is used to inject glue into the gap, and the glue can penetrate the inner layer structure to bond the inner layer structure to the predetermined object.

[0020] Optionally, the inner layer structure is provided with a plurality of glue penetration holes for the glue to penetrate, and the glue penetration holes are connected to the gap.

[0021] The present invention provides a ventricular assist compression device, comprising an inner layer structure, an outer layer structure and a compression unit, wherein the outer layer structure is sleeved on the outside of the inner layer structure; a cavity is provided between the inner layer structure and the outer layer structure, and the compression unit is used to be movably provided in the cavity. The ventricular assist compression device has at least a compressed state and a released state; in the released state, the inner layer structure is used to cover at least part of the outer surface of a predetermined object, the compression unit is used to alternately expand and contract, and the compression unit presses the predetermined object when expanded, and the compression unit can also be moved out of the cavity.

[0022] The device movably sets the pressing unit in the cavity between the inner structure and the outer structure. In this way, when the pressing unit fails or needs to be deactivated, if the inner structure and the outer structure undergo endothelialization, the pressing unit can be withdrawn from the cavity and removed from the body, thereby minimizing the retention of materials in the body, reducing the impact of the retained materials on the patient's cardiac work, and avoiding interference with the fixation and implantation of subsequent treatment devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic diagram of the three-dimensional structure of a ventricular assist compression device in a preferred embodiment of the present invention, wherein the compression unit can be observed through the outer structure;

[0024] Figure 2 It is a schematic diagram of a partial front view of the structure of a ventricular assist compression device in a preferred embodiment of the present invention, wherein the outer structures on both sides of the compression unit are cut and removed so that the compression unit can be observed;

[0025] Figure 3 It is a partial front view structural diagram of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the outer structures on both sides of the compression unit are cut and removed so that the compression unit can be observed;

[0026] Figure 4 It is a partial front view structural diagram of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the outer structures on both sides of the compression unit are cut and removed so that the compression unit can be observed;

[0027] Figure 5 It is a schematic diagram of a partial axial cross-section structure of a ventricular assist compression device in a preferred embodiment of the present invention;

[0028] Figure 6a Schematic diagram of a use scenario of a ventricular assist compression device in a preferred embodiment of the present invention, wherein the sac is in an expanded state, and arrow a indicates the direction in which the working medium flows into the sac;

[0029] Figure 6bSchematic diagram of a use scenario of a ventricular assist compression device in a preferred embodiment of the present invention, wherein the sac is in a contracted state, and arrow b is the direction in which the working medium flows out of the sac;

[0030] Figure 7 It is a schematic diagram of the three-dimensional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the compression unit can be observed through the outer structure;

[0031] Figure 8 It is a schematic diagram of an axial cross-sectional structure of a ventricular assist compression device in another preferred embodiment of the present invention;

[0032] Fig. 9 It is a schematic diagram of the three-dimensional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the compression unit can be observed through the outer structure;

[0033] Fig.10a It is a schematic diagram of an axial cross-sectional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the compression unit is disposed in a cavity between the inner layer structure and the outer layer structure;

[0034] Fig.10b It is a schematic diagram of an axial cross-sectional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the compression unit is partially moved out of the cavity between the inner layer structure and the outer layer structure;

[0035] Fig.11a It is a schematic diagram of the three-dimensional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the support structure is located at the distal end of the first delivery pipeline;

[0036] Fig.11b It is a schematic diagram of the three-dimensional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the support structure is moved into the first delivery pipeline, and arrow b is the withdrawal direction of the support structure;

[0037] Fig.11c It is a schematic diagram of the three-dimensional structure of a ventricular assist compression device in another preferred embodiment of the present invention, wherein the support structure and the second delivery pipeline are withdrawn from the body, and arrow a is the implantation direction of the fixing ring;

[0038] Fig.12a This is a schematic diagram of the three-dimensional structure of the inner layer structure in a preferred embodiment of the present invention;

[0039] Figure 12b for Fig.12a Enlarged view of part A.

[0040] In the figure: inner layer structure 1; outer layer structure 2; first film 21; second film 22; pressing unit 3; bag 31; fluid pipeline 32; cavity 4; limiting plate 511; long side 5111; short side 5112; first opening 512; first accommodating cavity 513; convex portion 521; concave portion 522; pressing line 61; second opening 62; second accommodating cavity 63; supporting structure 7; first conveying pipeline 81; second conveying pipeline 82; coating 91; glue injection pipeline 92; glue seepage hole 93; fixing ring 10. DETAILED DESCRIPTION

[0041] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the accompanying drawings are in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0042] The orientation or position relationship indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like are based on the orientation or position relationship shown in the drawings and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention.

[0043] In the present invention, unless otherwise clearly specified and limited, the terms "installation", "connection", "fixation" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or a connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0044] In the description of the present invention, "multiple" means at least two, such as two or three or more. In the description of the present invention, "proximal end" generally refers to the end close to the operator; "distal end" is the end opposite to the "proximal end", generally refers to the end away from the operator, that is, the end that first enters the body. In the description of the present invention, "circumferential direction of the inner layer structure" refers to the direction surrounding the left ventricle and the right ventricle.

[0045] The present invention is described in detail below in conjunction with the accompanying drawings and preferred embodiments. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

[0046] like Figure 1 As shown, a preferred embodiment of the present invention provides a ventricular assist compression device, comprising an inner layer structure 1, an outer layer structure 2 and a compression unit 3, wherein the outer layer structure 2 is sleeved outside the inner layer structure 1, and the distal end of the inner layer structure 1 is circumferentially connected to the distal end of the outer layer structure 2. A cavity 4 is provided between the inner layer structure 1 and the outer layer structure 2, and the compression unit 3 is used to be movably arranged in the cavity 4.

[0047] The ventricular assist compression device has at least a compressed state and a released state; in the compressed state, the inner layer structure 1, the outer layer structure 2 and the pressing unit 3 are all loaded in the delivery pipeline for implantation. After the distal end of the delivery pipeline reaches the apex position, it no longer moves. At this time, the inner layer structure 1, the outer layer structure 2 and the pressing unit 3 are pushed to the distal end so that the inner layer structure 1, the outer layer structure 2 and the pressing unit 3 are released after being moved out of the delivery pipeline. In the released state, the inner layer structure 1 is used to cover at least part of the outer surface of the predetermined object, and the pressing unit 3 is used to alternately expand and contract, and the pressing unit 3 presses the predetermined object when it expands. Specifically, the pressing unit 3 expands and contracts alternately within a time period, and periodic pressing of the predetermined object can be achieved. The pressing unit 3 can also move out of the cavity 4. Specifically, after the pressing unit 3 stops working (i.e., stops expanding and contracting), it can move out of the cavity 4 after receiving a force from the distal end to the proximal end.

[0048] It should be understood that the alternate expansion and contraction of the pressing unit 3 means that the pressing unit 3 can work reciprocatingly in the manner of expansion, contraction, re-expansion, and re-contraction, and can apply pressing force to the heart when expanding to periodically assist the heart in doing work.

[0049] It should also be understood that the predetermined object usually refers to the heart. The ventricular assist compression device can be placed between the heart and the pericardium after implantation. The pericardium is a thin film wrapped around the outside of the heart. The inner structure 1 mainly covers the outer wall of the myocardial tissue of the heart to assist in pressing the heart, thereby pumping more blood to the whole body.

[0050] Specifically, the shape of the inner surface of the inner layer structure 1 can be obtained by reverse reconstruction based on the patient's heart image data, so that the inner layer structure 1 can be closely attached to the outer surface of the heart after implantation and release. After the pressing unit 3 is implanted and released, the working medium can be injected into the pressing unit 3 to expand the whole unit toward the heart, thereby assisting in pressing the heart and providing auxiliary power for the heart.

[0051] The present application does not limit the type of working medium, and the working medium includes but is not limited to gases such as nitrogen, helium, and compressed air, and includes but is not limited to liquids such as pure water or saline.

[0052] It should be noted that when the ventricular assist compression device is implanted for a long time, the surface of the device in contact with the heart tissue will undergo endothelialization, causing the device to be fixed at the apex of the heart. If the device fails or cannot be removed when it needs to be discontinued, it may affect the normal work of the patient's heart and the fixation and implantation of subsequent treatment devices.

[0053] The ventricular assist compression device provided by the present invention movably places the compression unit 3 in the cavity 4 between the inner layer structure 1 and the outer layer structure 2. In this way, when the compression unit 3 fails or needs to be deactivated, even if the inner layer structure 1 and the outer layer structure 2 undergo endothelialization, the compression unit 3 can be extracted from the cavity 4 and removed from the body, thereby minimizing the retained materials of the device in the body, thereby reducing the impact of the retained materials on the patient's cardiac work and avoiding interference with the fixation and implantation of subsequent treatment devices as much as possible.

[0054] Preferably, at least one of the inner layer structure 1 and the outer layer structure 2 is composed of at least one layer of polymer film. In this way, after the pressing unit 3 is withdrawn, only two or more layers of polymer film remain in the patient's body, so as to minimize the retained materials in the patient's body and avoid affecting the heart's work and subsequent treatment measures.

[0055] Preferably, the inner layer structure 1 may also be a composite flexible material with reinforced fibers or a reinforced mesh structure to limit further expansion of the heart of a heart failure patient after implantation.

[0056] Furthermore, a fixing piece is provided on the outer surface of the inner layer structure 1 facing the pressing unit 3, and the pressing unit 3 is connected to the inner layer structure 1 through the fixing piece to prevent the pressing unit 3 from moving relative to the inner layer structure 1. When the pressing unit 3 is subjected to a force from the distal end to the proximal end of the inner layer structure 1, the pressing unit 3 is separated from the inner layer structure 1 and can be moved out of the cavity 4, and the proximal end of the inner layer structure 1 and the proximal end of the outer layer structure 2 are at least partially disconnected, so that the pressing unit 3 can be withdrawn from the body. The pressing unit 3 is movably arranged on the inner layer structure 1, so that the displacement of the pressing unit 3 during operation can be avoided, thereby ensuring the effect of the ventricular assist pressing device on the heart's auxiliary work.

[0057] In another embodiment, the fixing member may be disposed on the inner surface of the outer layer structure 2 (i.e., the surface of the outer layer structure 2 facing the pressing unit 3), and the pressing unit 3 may be movably disposed on the outer layer structure 2 through the fixing member to prevent the pressing unit 3 from moving during operation. When the pressing unit 3 is subjected to axial tension of the outer layer structure 2, the pressing unit 3 may be separated from the outer layer structure 2, and then the pressing unit 3 may be withdrawn from the body.

[0058] Reference Figure 2 As shown, in an exemplary embodiment, the fixing member is a limiting piece 511, and the number of the fixing members is multiple, and the multiple fixing members together enclose a first accommodating cavity 513 having a first opening 512. The pressing unit 3 is used to enter and be limited in the first accommodating cavity 513 from the first opening 512, that is, after the pressing unit 3 enters the first accommodating cavity 513, it contacts the limiting piece 511 to be limited by the limiting piece 511. The pressing unit 3 is also used to move out of the first accommodating cavity 513 from the first opening 512.

[0059] In more detail, the limiting piece or the pressing unit 3 can be deformed so that the pressing unit 3 can be moved into or out of the first accommodating chamber 513 from the first opening 512. After the pressing unit 3 enters the first accommodating chamber 513, the limiting piece 511 or the pressing unit 3 can restore its shape so that the pressing unit 3 is limited in the first accommodating chamber 513. The advantage of this is that when the pressing unit 3 fails or is deactivated, the pressing unit 3 can be removed and replaced, that is, the failed pressing unit 3 can be withdrawn from the first accommodating chamber 513, and a new pressing unit 3 can be transported to the first accommodating chamber 513, so as to extend the service life of the ventricular assist compression device.

[0060] The present application does not limit the shape of the pressing unit 3, which can be circular, square or irregular. The present application does not limit the shape of the limiting piece 511, which generally matches the outer contour of the pressing unit 3.

[0061] Continue to refer to Figure 2 In a specific example, the number of the limiting pieces 511 is two, and the two limiting pieces 511 are spaced apart in the circumferential direction of the inner layer structure 1. The shape of the pressing unit 3 is square, and the shape of the limiting piece 511 is L-shaped. The edge of the pressing unit 3 can be embedded in the limiting piece 511 to prevent the pressing unit 3 from shifting during expansion and contraction. The limiting piece 511 can be fixed to the inner layer structure 1 by heat pressing, bonding or other means. Specifically, the limiting piece 511 has a long side 5111 and a short side 5112. The two long sides 5111 of the two limiting pieces 511 can be arranged in parallel and fixed to the inner layer structure 1, and the two short sides 5112 of the two limiting pieces 511 can be arranged opposite to each other (refer to Figure 2 ) and is separated from the inner layer structure 1 to form a first opening 512.

[0062] In the cross section perpendicular to the axial direction of the inner layer structure 1, the width of the first opening 512 (i.e., the width between the short sides 5112 of the two limiting pieces 511) is smaller than the width of the pressing unit 3. In this way, when the pressing unit 3 is withdrawn or implanted for replacement, the short sides 5112 of the pressing unit 3 and / or the limiting piece 511 can be deformed so that the pressing unit 3 can be moved into or out of the first accommodating cavity 513 from the first opening 512. In addition, after the pressing unit 3 and the short sides 5112 of the limiting piece 511 are deformed, they can also automatically return to the initial position, at which time the long side 5111 and the short side 5112 of each limiting piece 511 can contact the pressing unit 3, thereby limiting the pressing unit 3 in the first accommodating cavity 513.

[0063] It should be explained that the strength of the material used to make the limiting piece 511 is preferably greater than the strength of the material used to make the inner layer structure 1, so that the limiting piece 511 can quickly return to its original shape after being deformed.

[0064] The present application does not limit the number and fixed positions of the limiting plates 511 . For example, the number of the limiting plates 511 may be set to 4, and they may be fixed at the four corner positions of the pressing unit 3 respectively.

[0065] Reference Figure 3 As shown, in another exemplary embodiment, the fixing member has one of the convex portion 521 and the concave portion 522, and the pressing unit 3 is provided with the other of the convex portion 521 and the concave portion 522, and the convex portion 521 is used to cooperate with the concave portion 522 to connect the inner layer structure 1 with the pressing unit 3. The convex portion 521 is also used to deform and release the cooperation with the concave portion 522 after the pressing unit 3 is subjected to the force from the distal end to the proximal end in the axial direction of the inner layer structure 1.

[0066] In a preferred example, the convex portion 521 is a spring sheet disposed on the inner layer structure 1, and the concave portion 522 is a through groove disposed on the pressing unit 3. When the pressing unit 3 is working, the spring sheet can be limited in the through groove to fix the pressing unit 3 on the inner layer structure 1. When the pressing unit 3 needs to be moved out, the pressing unit 3 is pulled toward the proximal end to deform the spring sheet and move out of the through groove, thereby separating the pressing unit 3 from the inner layer structure 1.

[0067] Reference Figure 4As shown, in another exemplary embodiment, the inner layer structure 1 and the outer layer structure 2 are sewn together to form a pressing line 61, and the pressing line 61 encloses a second accommodating cavity 63 having a second opening 62. The pressing unit 3 is used to enter and be limited in the second accommodating cavity 63 from the second opening 62, and the pressing unit 3 is also used to move out of the second accommodating cavity 63 from the second opening 62. In more detail, the pressing unit 3 can be deformed so that the pressing unit 3 moves into or out of the second accommodating cavity 63 from the second opening 62. After the pressing unit 3 enters the second accommodating cavity 63, the pressing unit 3 can restore its shape to be limited in the second accommodating cavity 63.

[0068] Continue to refer to Figure 4 As shown, in a specific example, the outer layer structure 2 includes a first film 21 and a second film 22, the second film 22 is sleeved on the outside of the first film 21, and the first film 21 and the inner layer structure 1 can be sewn to form a pressing line 61 to form a second accommodating cavity 63 with a second opening 62 between the first film 21 and the inner layer structure 1.

[0069] In more detail, in the cross section perpendicular to the axial direction of the inner layer structure 1, the width of the first opening 512 (i.e., the minimum distance of the compression line 61 at the opening position) is smaller than the width of the pressing unit 3. At this time, the pressing unit 3 can enter the second accommodating cavity 63 through the second opening 62 after deformation, and can restore its shape after entering to contact the inner wall of the bottom of the compression line 61 (i.e., the proximal end of the compression line 61), and then be limited in the second accommodating cavity 63. When the compression unit 3 fails or is deactivated, the compression unit 3 can be removed and replaced, that is, the failed compression unit 3 can be withdrawn from the second accommodating cavity 63, and a new compression unit 3 can be transported to the second accommodating cavity 63, so as to extend the service life of the ventricular assist compression device.

[0070] As another optional embodiment, the pressing unit 3 can be fixedly connected to the inner layer structure 1 through a degradable material. The degradable material can degrade after the pressing unit 3 is implanted in the body, so that the pressing unit 3 is separated from the inner layer structure 1, that is, after the degradable material is degraded, the restraint of the pressing unit 3 on the inner layer structure 1 can be released, and the pressing unit 3 can be withdrawn. When actually selecting the material, a degradable material with a suitable degradation time can be selected according to the time when the pressing unit 3 needs to be withdrawn.

[0071] The present application does not limit the types of degradable materials, and the degradable materials include but are not limited to degradable threads or degradable bio-glue.

[0072] In addition, a plurality of developing structures may be distributed on the inner layer structure 1 , the outer layer structure 2 and the pressing unit 3 , so as to facilitate the positioning of the pressing unit 3 during transportation, release and operation.

[0073] Reference Figure 5 As shown, combined with Figure 1The pressing unit 3 includes a bag 31 and a fluid pipeline 32. The bag 31 is placed in the cavity 4. One end of the fluid pipeline 32 is connected to the bag 31, and the other end extends outside the body. The fluid pipeline 32 is used to inject or extract the working medium into the bag 31. The bag 31 is used to expand after the working medium is injected, and to shrink after the working medium is extracted. After the bag 31 expands, it can apply a pressing force to the heart, so that the volume of the ventricle becomes smaller and the ventricular pressure increases, thereby increasing the amount of blood pumped by the ventricle and assisting the heart in doing work.

[0074] In a preferred case, there are multiple bladder bags 31 and fluid pipelines 32, and all bladder bags 31 are arranged at intervals in the circumferential direction of the inner layer structure 1. Each fluid pipeline 32 is connected to a corresponding bladder bag 31 and is used to inject or extract working medium into or from the corresponding bladder bag 31.

[0075] Furthermore, the ventricular assist compression device further includes a plurality of electrodes and a driving device (not shown), wherein the electrodes are placed in the cavity 4, for example, between two adjacent sac bags 31. The electrodes are used to measure the electrocardiogram signal when the heart is working, and the electrocardiogram signal is used to reflect the period and frequency of the contraction and expansion of the heart. The driving device is connected to the end of the fluid line 32 away from the sac bag 31, and is used to inject or extract the working medium into the fluid line 32 according to the electrocardiogram signal, so as to realize the periodic expansion and contraction of the sac bag 31, and enable the sac bag 31 to expand and press when the heart contracts.

[0076] Reference Figure 6a As shown, the driving device injects working medium into the bag 31 along the direction indicated by arrow a through the fluid pipeline 32 when the heart contracts, so that the bag 31 expands and presses the heart after expansion, thereby reducing the volume of the ventricle and pumping more blood into the whole body.

[0077] Reference Figure 6b As shown, the driving device also extracts the working medium in the sac 31 along the direction indicated by the arrow b through the fluid pipeline 32 when the heart expands, so as to prevent the pressing unit 3 from affecting the process of heart expansion. Due to the periodic expansion and contraction of the heart, the driving device can periodically inject or extract the working medium into the sac 31 according to the electrocardiographic signal of the heart, so that the expansion and contraction cycle of the sac 31 matches the contraction and expansion cycle of the heart.

[0078] Further, continue to refer to Figure 1 and Figure 5The ventricular assist compression device further comprises a fixing ring 10, which is sleeved on the outside of the fluid pipeline 32 and connected to multiple fluid pipelines 32 to restrain and limit all fluid pipelines 32. When the compression unit 3 is withdrawn, all the pouches 31, all the fluid pipelines 32 and the fixing ring 10 can be withdrawn synchronously. The fixing ring 10 can preferably be connected to a predetermined object, and specifically, the fixing ring 10 can be moved and sutured on the pericardium to achieve fixation of the entire ventricular assist device.

[0079] In order to slow down the endothelialization that may occur after the fixing ring 10 is fixed at the apex of the heart, a coating for delaying endothelialization is coated on the surface of at least one of the fixing ring 10 and the fluid line 32 (i.e., the surface of the fixing ring 10 or the surface of the fluid line 32, or the surfaces of the fixing ring 10 and the fluid line 32), so that the fixing ring 10 can be easily separated from the pericardium when the pressing unit 3 is withdrawn.

[0080] Preferably, the surfaces of the inner layer structure 1 and the outer layer structure 2 that are in contact with human tissues may also be coated with a coating that delays endothelialization to delay the degree of endothelialization of the inner layer structure 1 and the outer layer structure 2 .

[0081] Further, refer to Figure 7 to Figure 9 As shown, the ventricular assist compression device also includes a support structure 7, which is used to be placed between the inner layer structure 1 and the outer layer structure 2, and the support structure 7 can also be placed on the outer surface of the outer layer structure 1. Specifically, the support structure 7 can be placed in the cavity 4 between the inner layer structure 1 and the outer layer structure 2; when the inner layer structure 1 or the outer layer structure 2 is a multi-layer film, the support structure 7 can also be placed between the multi-layer films of the inner layer structure 1 or the outer layer structure 2. The support structure 7 can be compressed by an external force, and can also expand automatically after the external force is removed. After the support structure 7 expands, it can drive the inner layer structure 1 and the outer layer structure 2 to release and unfold. Specifically, the support structure 7 can shrink after being subjected to a compressive force; after the compression unit 3 is implanted in place, the support structure 7 can also drive the inner layer structure 1 and the outer layer structure 2 to release and unfold when released, so that the inner layer structure 1 encloses to form a chamber (unnumbered) that can be mounted on the heart.

[0082] As a preferred embodiment, the support structure 7 is a metal woven mesh (see Figure 8 ) or metal cutting bracket (refer to Figure 7 ), the support structure 7 can be arranged between the pressing unit 3 and the outer structure 2. When arranged in this way, the support structure 7 is used to reduce the displacement of the pressing unit 3 toward the outer structure 2 when it expands. That is to say, due to the high hardness of the support structure 7, it can avoid the pressing unit 3 from expanding toward the outer structure 2 as much as possible, and make the pressing unit 3 expand more toward the inner structure 1, so as to effectively press the heart, increase the amplitude of the pressing unit 3 pressing the heart, and thus improve the working capacity of the ventricular assist device.

[0083] Furthermore, the fixing ring 10 is sleeved on the outside of the fluid pipeline 32 of the pressing unit 3, and the fixing ring 10 is connected to multiple fluid pipelines 32 to restrain and limit all the fluid pipelines 32; the support structure 7 is connected to the fixing ring 10, and when the pressing unit 3 is withdrawn, the fixing ring 10 can drive the support structure 7 to be withdrawn synchronously, and only the inner layer structure 1 and the outer layer structure 2 are retained in the body.

[0084] Reference Figure 7 As shown, in one example, the support structure 7 is connected to the outer surface of the pressing unit 3 facing the outer layer structure 2, so that the pressing unit 3 is fixed on the support structure 7, and the support structure 7 can also be connected to the fixing ring 10, and the pressing unit 3 is used to drive the support structure 7 to move through the fixing ring 10. Specifically, when the pressing unit 3 is withdrawn, the fixing ring 10 and the support structure 7 can be withdrawn synchronously, and only the inner layer structure 1 and the outer layer structure 2 are retained in the body.

[0085] Reference Figure 8 As shown, in another example, the outer layer structure 2 includes a first film 21 and a second film 22, and the support structure 7 is a metal woven mesh and is fixed between the first film 21 and the second film 22 of the outer layer structure 2. The support structure 7 is connected to the fixing ring 10, and the pressing unit 3 is limited in the pressing line 61 formed by sewing the inner layer structure 1 and the first film 21. In this configuration, when the pressing unit 3 is withdrawn, it can drive the support structure 7 to move synchronously.

[0086] Return to reference Fig. 9 In an optional example, the support structure 7 is connected to the inner surface of the outer layer structure 2 facing the pressing unit 3, that is, the support structure 7 is fixed to the outer layer structure 2, for example, the support structure 7 and the outer layer structure 2 can be connected as a whole by heat pressing or bonding. The pressing unit 3 is used to move relative to the support structure 7. In this case, the pressing unit 3 can move relative to the support structure 7 when withdrawn, and the support structure 7 is retained in the body.

[0087] In an optional example, the inner layer structure 1 is a multi-layer polymer film, and the support structure 7 can also be placed between the multi-layer polymer films of the inner layer structure 1 to avoid interference between the support structure 7 and the fixing part or the pressing line 61, so that the support structure 7 is fixed in the inner layer structure 1 and cannot be smoothly withdrawn from the cavity 4.

[0088] Further, the ventricular assist compression device includes a first delivery pipeline 81 and a second delivery pipeline 82. In one example, referring to Fig.10a and Fig.10b As shown, the inner layer structure 1, the outer layer structure 2, and the pressing unit 3 can all be compressed in the first delivery pipeline 81 for delivery and implantation. Fig.10aAs shown, after the inner layer structure 1, the outer layer structure 2 and the pressing unit 3 are released from the restraint of the first delivery tube 81, the inner layer structure 1 covers the heart. Fig.10b As shown, when the position of the pressing unit 3 needs to be adjusted, or the pressing unit 3 fails and needs to be withdrawn or replaced, the fluid pipeline 32 can be pulled in the direction indicated by the arrow b to pull the bag 31 and the fixing ring 10 back into the first delivery pipeline 81, so as to readjust the position of the pressing unit 3 or withdraw the pressing unit 3 out of the body.

[0089] Reference Figure 11a to Figure 11c As shown, the support structure 7 is arranged between the pressing unit 3 and the outer layer structure 2, and the second delivery pipeline 82 is connected to the support structure 7. At this time, the support structure 7 is separated from the outer layer structure 2 and the pressing unit 3. After the inner layer structure 1 covers the predetermined object, the support structure 7 is moved out of the cavity 4 under the drive of the second delivery pipeline 82. In this embodiment, one end of the second delivery pipeline 82 extends out of the first delivery pipeline 81, and the other end passes through the first delivery pipeline 81 and is connected to the support structure 7, and the fluid pipeline 32 passes through the second delivery pipeline 82 and is connected to the pouch 31.

[0090] When the whole device is implanted, the inner layer structure 1, the outer layer structure 2, the pressing unit 3, the support structure 7 and at least part of the second delivery pipeline 82 are compressed in the first delivery pipeline 81. After the pressing unit 3 is delivered to the right position, the first delivery pipeline 81 is withdrawn, and the support structure 7 drives the inner layer structure 1 and the outer layer structure 2 to expand (refer to Fig.11a After the inner layer structure 1, the outer layer structure 2 and the pressing unit 3 are released into place and covered on the surface of the heart, the operator can pull the second delivery line 82 toward the proximal end to move the support structure 7 into the first delivery line 81 (refer to Fig.11b ), and the support structure 7, the first delivery pipeline 81 and the second delivery pipeline 82 are all withdrawn from the body. After the support structure 7 is withdrawn, the fixing ring 10 is sleeved outside the fluid pipeline 32 and transported into the body along the fluid pipeline 32 (refer to Fig.11c ) until the fixing ring 10 is sleeved and fixed on the pericardium, thereby completing the implantation of the entire device in the body.

[0091] Reference Fig.12a and Figure 12bIn a preferred case, at least part of the outer surface of the inner layer structure 1 is covered with a coating 91, and the coating 91 is preferably coated on the bottom of the inner layer structure 1 at the most proximal end, and there is a gap (not shown) between the coating 91 and the inner layer structure 1. The ventricular assist compression device also includes a glue injection pipeline 92, which is used to inject glue with good biocompatibility (such as biological glue) into the gap. The glue can penetrate the inner layer structure 1 to bond the inner layer structure 1 to a predetermined object, thereby achieving the fixation of the inner layer structure 1 to the heart and avoiding the displacement of the ventricular assist compression device. Preferably, the glue injection pipeline 92 and the fluid pipeline 32 are both arranged in the fixing ring 10.

[0092] In order to facilitate the glue to penetrate the inner layer structure 1, a plurality of glue penetration holes 93 for the glue to penetrate are provided on the inner layer structure 1. The glue penetration holes 93 are connected to the gap. The glue in the gap can enter between the inner layer structure 1 and the heart through the glue penetration holes 93 to bond the inner layer structure 1 to the outer surface of the heart.

[0093] The present application has no particular restrictions on the type of driving device, which may be hardware that performs logical operations, such as a single-chip microcomputer, a microprocessor, a programmable logic controller (PLC) or a field-programmable gate array (FPGA), or a software program, functional module, function, object library or dynamic-link library that implements the above functions based on hardware. It should be known how to specifically implement the communication between the driving device and other devices.

[0094] In summary, the ventricular assist compression device provided by the present invention movably arranges the compression unit 3 in the cavity 4 between the inner structure 1 and the outer structure 2. In this way, when the compression unit 3 fails or needs to be deactivated, if the inner structure 1 and the outer structure 2 undergo endothelialization, the compression unit 3 can be extracted from the cavity 4 and removed from the body, thereby reducing the retained materials of the device in the body, thereby reducing the impact of the retained materials on the patient's cardiac work, and avoiding interference with the fixation and implantation of subsequent treatment devices as much as possible.

[0095] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A ventricular assist compression device, characterized in that: It comprises an inner layer structure, an outer layer structure and a pressing unit, wherein the outer layer structure is sleeved on the outside of the inner layer structure; a cavity is provided between the inner layer structure and the outer layer structure, and the pressing unit is used to be movably arranged in the cavity; The ventricular assist pressing device has at least a compressed state and a released state; in the released state, the inner layer structure is used to cover at least a portion of the outer surface of the predetermined object, and the pressing unit is used to alternately expand and contract, and the pressing unit presses the predetermined object when expanded, and the pressing unit can also be moved out of the cavity.

2. The ventricular assist compression device according to claim 1, characterized in that: A fixing part is arranged on the outer surface of the inner layer structure facing the pressing unit, and the pressing unit is connected to the inner layer structure via the fixing part to prevent the pressing unit from moving relative to the inner layer structure; when the pressing unit is subjected to a force from the distal end toward the proximal end in the axial direction of the inner layer structure, the pressing unit is separated from the inner layer structure and can be moved out of the cavity.

3. The ventricular assist compression device according to claim 2, characterized in that: The fixing member is a limiting plate, and there are multiple fixing members, which together enclose a first accommodating cavity with a first opening; the pressing unit is used to enter the first accommodating cavity from the first opening and be limited in the first accommodating cavity, and the pressing unit is also used to move out of the first accommodating cavity from the first opening.

4. The ventricular assist compression device according to claim 2, characterized in that: The fixing part has one of a convex part and a concave part, and the pressing unit is provided with the other of the convex part and the concave part. The convex part is used to cooperate with the concave part so that the inner layer structure is connected to the pressing unit; the convex part is also used to deform and release the cooperation with the concave part after the pressing unit is subjected to a force acting from the distal end toward the proximal end in the axial direction of the inner layer structure.

5. The ventricular assist compression device according to claim 1, characterized in that: The inner layer structure and the outer layer structure are sewn together to form a pressing line, and the pressing line encloses a second accommodating cavity with a second opening; the pressing unit is used to enter from the second opening and be limited in the second accommodating cavity, and the pressing unit is also used to move out of the second accommodating cavity from the second opening.

6. The ventricular assist compression device according to claim 1, characterized in that: The pressing unit is fixedly connected to the inner layer structure via a degradable material; The degradable material can be degraded after the pressing unit is implanted in the body, so that the pressing unit is separated from the inner layer structure.

7. The ventricular assist compression device according to claim 1, characterized in that: At least one of the inner layer structure and the outer layer structure is composed of at least one layer of polymer film.

8. The ventricular assist compression device according to claim 1, characterized in that: The pressing unit includes a bag and a fluid pipeline, the bag is placed in the cavity, and the fluid pipeline is connected to the bag; the fluid pipeline is used to inject or extract a working medium into the bag; the bag is used to expand after the working medium is injected, and to shrink after the working medium is extracted; after the bag is expanded, it can apply a pressing force to the predetermined object.

9. The ventricular assist compression device according to claim 8, characterized in that: It also includes a fixing ring, which is sleeved on the outside of the fluid pipeline and connected to the fluid pipeline.

10. The ventricular assist compression device according to claim 8 or 9, characterized in that: Also included is a support structure, the support structure is used to be placed between the inner layer structure and the outer layer structure, the support structure can be compressed by external force, and can also automatically expand after the external force is removed; After the support structure expands, it can drive the inner layer structure and the outer layer structure to release.

11. The ventricular assist compression device according to claim 10, characterized in that: The support structure is a metal woven mesh or a metal cutting bracket, and the support structure is arranged between the pressing unit and the outer layer structure. The support structure is used to reduce the displacement of the pressing unit toward the outer layer structure when the pressing unit expands.

12. The ventricular assist compression device according to claim 10, characterized in that: It also includes a fixing ring, the fluid pipeline of the pressing unit is connected to the fixing ring; the supporting structure is connected to the fixing ring; and the pressing unit is used to drive the supporting structure to move through the fixing ring.

13. The ventricular assist compression device according to claim 12, characterized in that: It also includes a first delivery pipeline and a second delivery pipeline. In the compressed state, the inner layer structure, the outer layer structure and the pressing unit are all compressed in the first delivery pipeline and implanted into the human body; the support structure is arranged between the pressing unit and the outer layer structure, and the second delivery pipeline is connected to the support structure; After the inner layer structure covers the predetermined object, the support structure is moved out of the cavity under the driving of the second conveying pipeline.

14. The ventricular assist compression device according to any one of claims 1 to 8, characterized in that: At least part of the outer surface of the inner layer structure is covered with a coating, and there is a gap between the coating and the inner layer structure; the ventricular assist compression device also includes a glue injection pipeline, which is used to inject glue into the gap. The glue can penetrate the inner layer structure to bond the inner layer structure to the predetermined object.

15. The ventricular assist compression device according to claim 14, characterized in that: The inner layer structure is provided with a plurality of glue penetration holes for the glue to penetrate, and the glue penetration holes are communicated with the gap.

Images