Ventricular support device

Abstract

This invention provides a ventricular assist compression device, comprising an inner layer structure, an outer layer structure, and a compression unit. The outer layer structure is sleeved outside the inner layer structure. A cavity is provided between the inner and outer layer structures, and the compression unit is movably disposed within 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 covers a portion of the outer surface of a predetermined object, and the compression unit alternately expands and contracts. When expanded, the compression unit presses against the predetermined object, and the compression unit can also be removed from the cavity. The compression unit of this device can be removed from between the inner and outer layer structures, thereby reducing the amount of material retained in the body after device failure, thus mitigating the impact of retained material on the patient's heart or preventing interference with subsequent cardiac interventions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a ventricular assist compression device. Background Technology

[0002] Current ventricular assist devices typically use pulsatile pumps, axial flow pumps, or centrifugal pumps to directly work on the blood flow, increasing blood flow velocity and pressure, thereby assisting the left or right ventricle in its function. All of these ventricular assist devices have components (such as pump housings, impellers, and blood inlet or outlet tubing) in direct contact with the blood. Furthermore, because the impeller exerts a driving force on the blood after contact, this process can easily cause blood compatibility risks such as coagulation or hemolysis. This may lead to problems such as peripheral artery thrombosis and internal bleeding after ventricular assist device implantation, and in severe cases, even death.

[0003] In recent years, numerous companies and research institutions have been developing non-blood-contact ventricular assist devices (VADs). Currently, common non-blood-contact VADs provide the heart with additional pumping power through periodic chest compressions. Because these devices do not come into direct contact with blood, they effectively avoid the risks associated with blood compatibility issues. Furthermore, implantation of these devices does not require puncture at the apex of the heart, thus avoiding permanent damage to myocardial tissue. This is more conducive to the recovery of cardiac function in heart failure patients, and also facilitates earlier treatment, improving long-term survival rates.

[0004] Currently, common non-blood-contact ventricular assist devices (VADs) are sheaths that fit over the outer wall of the heart. These sheaths contain multiple inflatable balloons connected to corresponding external gas lines. During use, the balloons expand and contract with inflation, providing the heart with the necessary pumping force to assist the heart in pumping blood throughout the body. However, in existing VADs, the multiple balloons are designed as a single unit; individual balloons cannot move independently. If a single inflatable balloon ruptures or becomes blocked, it cannot be removed from the sheath or replaced, leading to a decrease in the VAD's functional capacity. Furthermore, due to prolonged implantation, the surface of the sheath in contact with the heart undergoes endothelialization (i.e., the sheath becomes embedded in the heart's outer wall tissue), making removal difficult. The integrated balloons are also difficult to remove from within the sheath, posing a risk of device failure. This can impair normal heart function and potentially worsen the patient's condition. Summary of the Invention

[0005] The purpose of this invention is to provide a ventricular assist compression device, wherein the compression unit of the device can be removed between the inner and outer layers, thereby reducing the amount of material retained in the body after device failure, and thus mitigating the impact of the retained material on the patient's heart function.

[0006] To achieve the above objectives, 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 outside the inner layer structure; a cavity is provided between the inner layer structure and the outer layer structure, and the compression unit is movably disposed within 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 a portion of the outer surface of a predetermined object, and the compression unit is used to alternately expand and contract, wherein the compression unit presses the predetermined object when it expands, and the compression unit is also capable of moving out of the cavity.

[0007] Optionally, a fixing member 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 through the fixing member 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 to the proximal end in the axial direction of the inner layer structure, the pressing unit separates from the inner layer structure and can be moved out of the cavity.

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

[0009] Optionally, the fastener has one of a protrusion and a recess, and the pressing unit is provided with the other of the protrusion and the recess. The protrusion is used to engage with the recess to connect the inner layer structure to the pressing unit. The protrusion is also used to deform and disengage from the recess after the pressing unit is subjected to a force in the axial direction of the inner layer structure from the distal end to the proximal end.

[0010] Optionally, the inner layer structure and the outer layer structure are stitched together to form a press line, and the press line encloses a second receiving cavity with a second opening; the pressing unit is used to enter from the second opening and be confined in the second receiving cavity, and the pressing unit is also used to remove from the second opening into the second receiving cavity.

[0011] Optionally, the pressing unit is fixedly connected to the inner layer structure via a biodegradable material; the biodegradable material can degrade after the pressing unit is implanted in the body, thereby separating the pressing unit from the inner layer structure.

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

[0013] Optionally, the pressing unit includes a bladder and a fluid conduit, the bladder being placed in the cavity and the fluid conduit being connected to the bladder; the fluid conduit is used to inject or extract a working medium into the bladder; the bladder is used to expand after the working medium is injected and to contract after the working medium is extracted; the expanded bladder is capable of applying pressing pressure to the predetermined object.

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

[0015] Optionally, the ventricular assist compression device further includes a support structure, which is placed between the inner structure and the outer 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 structure and the outer structure to release.

[0016] Optionally, the support structure is a metal woven mesh or a metal cut bracket, and the support structure is disposed 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 it expands.

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

[0018] Optionally, the ventricular assist compression device further includes a first delivery line and a second delivery line. In the compressed state, the inner layer structure, the outer layer structure, and the compression unit are all compressed in the first delivery line and implanted into the human body. The support structure is disposed between the compression unit and the outer layer structure, and the second delivery line is connected to the support structure. After the inner layer structure covers the predetermined object, the support structure moves out of the cavity under the drive of the second delivery line.

[0019] Optionally, at least a portion 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 device further includes an adhesive injection line for injecting adhesive into the gap, the adhesive being able to pass through 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 glue to pass through, and the glue penetration holes are in communication with the gap.

[0021] This 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 outside the inner layer structure; a cavity is provided between the inner layer structure and the outer layer structure, and the compression unit is movably disposed within 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 covers at least a portion of the outer surface of a predetermined object, and the compression unit alternately expands and contracts; the compression unit presses against the predetermined object during expansion, and the compression unit is also capable of moving out of the cavity.

[0022] The device movably positions the compression unit within a cavity between the inner and outer layers. This allows the compression unit to be withdrawn from the cavity and removed from the body if the inner and outer layers become endothelialized when the compression unit fails or needs to be deactivated. This minimizes the amount of material remaining in the body, reducing its impact on the patient's heart function and minimizing interference with the fixation and implantation of subsequent treatment devices. Attached Figure Description

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

[0024] Figure 2 This is a partial front view of the 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 off and removed so that the compression unit can be observed.

[0025] Figure 3 This is a partial front view of the 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 off and removed so that the compression unit can be observed;

[0026] Figure 4 This is a partial front view of the 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 off and removed so that the compression unit can be observed.

[0027] Figure 5 This is a partial axial cross-sectional view of the ventricular assist device in a preferred embodiment of the present invention;

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

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

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

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

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

[0033] Figure 10a This is an axial cross-sectional view of the ventricular assist compression device in another preferred embodiment of the present invention, wherein the compression unit is placed in the cavity between the inner layer structure and the outer layer structure;

[0034] Figure 10b This is an axial cross-sectional view of the ventricular assist compression device in another preferred embodiment of the present invention, wherein the compression unit is partially removed from the cavity between the inner and outer layers of the structure;

[0035] Figure 11a This is a three-dimensional structural diagram of the 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] Figure 11b This is a three-dimensional structural diagram of the 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 direction of withdrawal of the support structure.

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

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

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

[0040] In the diagram: Inner layer structure 1; Outer layer structure 2; First film 21; Second film 22; Pressing unit 3; Bag 31; Fluid conduit 32; Cavity 4; Limiting piece 511; Long side 5111; Short side 5112; First opening 512; First receiving cavity 513; Protrusion 521; Recess 522; Pressing line 61; Second opening 62; Second receiving cavity 63; Support structure 7; First delivery conduit 81; Second delivery conduit 82; Covering film 91; Glue injection conduit 92; Glue penetration hole 93; Fixing ring 10. Detailed Implementation

[0041] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0042] The terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0043] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "fixation," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or a connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0044] In the description of this invention, "a plurality of" means at least two, such as two, three, or more. In the description of this invention, "proximal" generally refers to the end closer to the surgeon; "distal" is the opposite of "proximal," generally referring to the end farther from the surgeon, i.e., the end that first enters the body. In the description of this invention, "circumferential direction of the inner structure" refers to the direction surrounding the left and right ventricles.

[0045] The present invention will now be described in detail with reference to the accompanying drawings and preferred embodiments. Unless otherwise specified, the following embodiments and features can complement or combine with each other.

[0046] like Figure 1 As shown, a preferred embodiment of the present invention provides a ventricular assist device, including an inner structure 1, an outer structure 2, and a pressing unit 3. The outer structure 2 is sleeved outside the inner structure 1, and the distal end of the inner structure 1 and the distal end of the outer structure 2 are circumferentially connected. A cavity 4 is provided between the inner structure 1 and the outer structure 2, and the pressing unit 3 is movably disposed in the cavity 4.

[0047] The ventricular assist 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 compression unit 3 are all implanted in the delivery tubing. After the distal end of the delivery tubing reaches the apex of the heart and stops moving, the inner layer structure 1, the outer layer structure 2, and the compression unit 3 are pushed further distally to release them from the delivery tubing. In the released state, the inner layer structure 1 covers at least a portion of the outer surface of the intended target, and the compression unit 3 alternately expands and contracts, compressing the intended target when expanding. Specifically, the compression unit 3 expands and contracts alternately within a time period, enabling periodic compression of the intended target. The compression unit 3 can also be removed from the cavity 4. Specifically, after the compression unit 3 stops working (i.e., after it stops expanding and contracting), it can be removed from the cavity 4 after being subjected to a force from the distal end to the proximal end.

[0048] It should be understood that the alternating expansion and contraction of the aforementioned pressing unit 3 means that the pressing unit 3 can work repeatedly in a manner of expansion, contraction, re-expansion, and re-contraction, and can apply pressing pressure to the heart during expansion to periodically assist the heart in working.

[0049] It should also be understood that the intended target usually refers to the heart. The ventricular assist device can be placed between the heart and the pericardium after implantation. The pericardium is a thin membrane that wraps 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 imaging data of the patient's heart, so that the inner layer structure 1 can fit closely to the outer surface of the heart after implantation and release. After the compression unit 3 is implanted and released, the working medium can be injected into the compression unit 3 to make it expand towards the heart, assisting in pressing the heart and thus providing auxiliary power to the heart.

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

[0052] It should be noted that when a ventricular assist device is implanted for an extended period, the surface of the device in contact with the heart tissue undergoes endothelialization, causing the device to become 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 functioning of the patient's heart, as well as 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. Thus, when the compression unit 3 fails or needs to be discontinued, even if the inner layer structure 1 and the outer layer structure 2 become endothelialized, the compression unit 3 can be pulled out of the cavity 4 and removed from the body. This can minimize the amount of material retained in the body, reduce the impact of retained material on the patient's heart function, and minimize interference with the fixation and implantation of subsequent treatment devices.

[0054] Preferably, at least one of the inner layer structure 1 and the outer layer structure 2 consists of at least one layer of polymer film. Thus, after the pressing unit 3 is withdrawn, only two or more layers of polymer film remain in the patient's body, minimizing the amount of material retained and avoiding interference with cardiac function and subsequent treatment.

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

[0056] Furthermore, a fixing member is provided on the outer surface of the inner layer structure 1 facing the pressing unit 3. The pressing unit 3 is connected to the inner layer structure 1 through the fixing member 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 separates from the inner layer structure 1 and can be moved out of the cavity 4. The proximal end of the inner layer structure 1 and the proximal end of the outer layer structure 2 are at least partially disconnected, thereby allowing the pressing unit 3 to be withdrawn from the body. By movably mounting the pressing unit 3 on the inner layer structure 1, displacement of the pressing unit 3 during operation can be avoided, ensuring the effectiveness of the ventricular assist device in assisting cardiac work.

[0057] In another embodiment, the fixing member can also 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). In this case, the pressing unit 3 is movably disposed on the outer layer structure 2 by means of the fixing member to prevent the pressing unit 3 from moving during operation. When the pressing unit 3 is subjected to an axial tensile force from the outer layer structure 2, the pressing unit 3 can separate from the outer layer structure 2, thereby removing the pressing unit 3 from the body.

[0058] Reference Figure 2 As shown, in one illustrative embodiment, the fixing member is a limiting piece 511, and there are multiple fixing members, which together enclose a first receiving cavity 513 with a first opening 512. The pressing unit 3 is used to enter and be limited in the first receiving cavity 513 from the first opening 512, that is, after the pressing unit 3 enters the first receiving cavity 513, it contacts the limiting piece 511 to be limited by the limiting piece 511. The pressing unit 3 is also used to remove the first receiving cavity 513 from the first opening 512.

[0059] More specifically, the limiting plate or pressing unit 3 can deform to allow the pressing unit 3 to move into or out of the first receiving cavity 513 from the first opening 512. After the pressing unit 3 enters the first receiving cavity 513, the limiting plate 511 or the pressing unit 3 can return to its shape to retain the pressing unit 3 within the first receiving cavity 513. This allows the pressing unit 3 to be removed and replaced when it fails or is no longer needed. The failed pressing unit 3 can be removed from the first receiving cavity 513, and a new pressing unit 3 can be delivered to the first receiving cavity 513, thus extending the service life of the ventricular assist device.

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

[0061] Continue to refer to Figure 2 In one specific example, there are two limiting pieces 511, which are spaced apart circumferentially in the inner layer structure 1. The pressing unit 3 is square in shape, and 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 parallel to each other and fixed to the inner layer structure 1, while the two short sides 5112 of the two limiting pieces 511 are arranged facing each other (see reference). Figure 2 It separates from the inner structure 1 to form the first opening 512.

[0062] In a cross-section perpendicular to the axial direction of the inner 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. Thus, when the pressing unit 3 is removed or replaced, the short sides 5112 of the pressing unit 3 and / or the limiting pieces 511 can deform, allowing the pressing unit 3 to move into or out of the first receiving cavity 513 from the first opening 512. Furthermore, after deformation, the short sides 5112 of the pressing unit 3 and the limiting pieces 511 can automatically return to their initial positions, at which point the long side 5111 and short side 5112 of each limiting piece 511 can contact the pressing unit 3, thereby confining the pressing unit 3 within the first receiving cavity 513.

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

[0064] This application does not limit the number and fixed position of the limiting piece 511. For example, the number of limiting pieces 511 can be set to 4, and they can be fixed at the four corner positions of the pressing unit 3 respectively.

[0065] Reference Figure 3 As shown, in another illustrative embodiment, the fastener has one of a protrusion 521 and a recess 522, and the pressing unit 3 is provided with the other of the protrusion 521 and recess 522. The protrusion 521 is used to engage with the recess 522 to connect the inner layer structure 1 to the pressing unit 3. The protrusion 521 is also used to deform and disengage from the recess 522 after the pressing unit 3 is subjected to a force in the axial direction of the inner layer structure 1 from the distal end to the proximal end.

[0066] In a preferred embodiment, the protrusion 521 is a spring piece disposed on the inner layer structure 1, and the recess 522 is a through groove disposed on the pressing unit 3. When the pressing unit 3 is in operation, the spring piece can be confined in the through groove to fix the pressing unit 3 on the inner layer structure 1. When the pressing unit 3 needs to be removed, pulling the pressing unit 3 towards the proximal end can deform the spring piece and remove it from the through groove, thereby separating the pressing unit 3 from the inner layer structure 1.

[0067] Reference Figure 4As shown, in another illustrative embodiment, the inner layer structure 1 and the outer layer structure 2 are stitched together to form a crimp line 61, which encloses a second receiving cavity 63 having a second opening 62. A pressing unit 3 is used to enter and be contained within the second receiving cavity 63 through the second opening 62, and the pressing unit 3 is also used to remove itself from the second receiving cavity 63 through the second opening 62. More specifically, the pressing unit 3 is deformable to allow it to move into or out of the second receiving cavity 63 from the second opening 62. After entering the second receiving cavity 63, the pressing unit 3 is able to return to its original shape to remain contained within the second receiving 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. The first film 21 and the inner layer structure 1 can be stitched together to form a pressing line 61, so as to form a second receiving cavity 63 with a second opening 62 between the first film 21 and the inner layer structure 1.

[0069] More specifically, in a cross-section perpendicular to the axial direction of the inner structure 1, the width of the first opening 512 (i.e., the minimum distance between the pressure lines 61 at the opening position) is smaller than the width of the pressing unit 3. In this case, the pressing unit 3 can deform and enter the second receiving cavity 63 through the second opening 62, and can recover its shape after entering to contact the inner wall of the bottom (i.e., the proximal end of the pressure lines 61), thereby confining it within the second receiving cavity 63. When the pressing unit 3 fails or is discontinued, it can be removed and replaced. This allows the failed pressing unit 3 to be withdrawn from the second receiving cavity 63, and a new pressing unit 3 to be delivered to the second receiving cavity 63, thus extending the service life of the ventricular assist device.

[0070] As another optional implementation, the pressing unit 3 can be fixedly connected to the inner layer structure 1 via a biodegradable material. The biodegradable material degrades after the pressing unit 3 is implanted in the body, allowing the pressing unit 3 to separate from the inner layer structure 1. This means that the degradation of the biodegradable material releases the pressing unit 3 from the inner layer structure 1, thus enabling the retraction of the pressing unit 3. In actual material selection, a biodegradable material with a suitable degradation time can be chosen based on the required retraction time of the pressing unit 3.

[0071] This application does not limit the types of biodegradable materials, which include, but are not limited to, biodegradable yarn or biodegradable bio-adhesive.

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

[0073] Reference Figure 5 As shown, and in combination Figure 1The compression unit 3 includes a cuff 31 and a fluid conduit 32. The cuff 31 is placed in the cavity 4. One end of the fluid conduit 32 is connected to the cuff 31, and the other end extends outside the body. The fluid conduit 32 is used to inject or withdraw the working medium into the cuff 31. The cuff 31 is used to inflate after the working medium is injected and to contract after the working medium is withdrawn. When the cuff 31 inflates, it can apply compression pressure to the heart, causing the ventricular volume to decrease and the ventricular pressure to increase, thereby increasing the amount of blood pumped by the ventricles and assisting the heart in its work.

[0074] In a preferred embodiment, there are multiple bags 31 and fluid lines 32, with all bags 31 spaced apart circumferentially in the inner structure 1. Each fluid line 32 is connected to a corresponding bag 31 and is used to inject or extract the working medium into or from the corresponding bag 31.

[0075] Furthermore, the ventricular assist device also includes several electrodes and a drive mechanism (not shown). The electrodes are placed within the cavity 4, for example, between two adjacent pockets 31. The electrodes are used to measure the electrocardiogram (ECG) signals during cardiac activity, which reflect the period and frequency of cardiac contraction and expansion. The drive mechanism is connected to the end of the fluid conduit 32 away from the pocket 31 and is used to inject or extract working medium into the fluid conduit 32 according to the ECG signals, so as to achieve the periodic expansion and contraction of the pockets 31, enabling the pockets 31 to expand and compress during cardiac contraction.

[0076] Reference Figure 6a As shown, the drive device injects working medium into the sac 31 in the direction indicated by arrow a through the fluid line 32 when the heart contracts, so that the sac 31 expands and then presses the heart to reduce the volume of the ventricles, so as to pump more blood into the whole body.

[0077] Reference Figure 6b As shown, the drive device also extracts the working medium from the pouch 31 in the direction indicated by arrow b during cardiac expansion via the fluid conduit 32, to avoid the pressing unit 3 affecting the cardiac expansion process. Due to the periodic expansion and contraction of the heart, the drive device can periodically inject or extract the working medium into the pouch 31 according to the heart's electrocardiogram signal, so that the period of expansion and contraction of the pouch 31 is matched with the period of contraction and expansion of the heart.

[0078] Furthermore, continue to refer to Figure 1 and Figure 5The ventricular assist device also includes a retaining ring 10, which is fitted over the fluid lines 32 and connected to multiple fluid lines 32 to restrain and limit all fluid lines 32. When the compression unit 3 is withdrawn, all pockets 31, all fluid lines 32, and the retaining ring 10 can be withdrawn simultaneously. The retaining ring 10 is preferably connected to a predetermined object; specifically, the retaining ring 10 can be moved and sewn onto the pericardium to secure the entire ventricular assist device.

[0079] To mitigate potential endothelialization after the fixation ring 10 is fixed at the apex of the heart, at least one surface of the fixation ring 10 and the fluid conduit 32 (i.e., the surface of the fixation ring 10 or the surface of the fluid conduit 32, or the surfaces of the fixation ring 10 and the fluid conduit 32) is coated with a coating to delay endothelialization, which facilitates the separation of the fixation ring 10 from the pericardium when the compression unit 3 is withdrawn.

[0080] Preferably, the surfaces of the inner structure 1 and the outer structure 2 that come into contact with human tissue can also be coated with a coating that delays endothelialization, so as to delay the degree of endothelialization of the inner structure 1 and the outer structure 2.

[0081] Furthermore, referring to Figures 7-9 As shown, the ventricular assist device also includes a support structure 7, which is placed between the inner structure 1 and the outer structure 2. The support structure 7 can also be placed on the outer surface of the outer structure 1. Specifically, the support structure 7 can be placed in the cavity 4 between the inner structure 1 and the outer structure 2; when the inner structure 1 or the outer structure 2 is a multi-layered thin film, the support structure 7 can also be placed between the multi-layered thin films of the inner structure 1 or the outer structure 2. The support structure 7 can be compressed by external force and can automatically expand after the external force is removed. After the support structure 7 expands, it can drive the inner structure 1 and the outer structure 2 to release and unfold. Specifically, the support structure 7 can contract after being compressed; after the compression unit 3 is implanted, the support structure 7 can also drive the inner structure 1 and the outer structure 2 to release and unfold upon release, so that the inner structure 1 encloses and forms a chamber (unlabeled) that can accommodate the heart.

[0082] As a preferred embodiment, the support structure 7 is a metal woven mesh (see reference). Figure 8 ) or metal cutting bracket (refer to) Figure 7 The support structure 7 can be disposed between the pressing unit 3 and the outer structure 2. When disposed 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 rigidity 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 function 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. The fixing ring 10 is connected to multiple fluid pipelines 32 to bind and limit all fluid pipelines 32. The support structure 7 is connected to the fixing ring 10. When the pressing unit 3 is withdrawn, the support structure 7 can be withdrawn synchronously through the fixing ring 10, while only the inner layer structure 1 and the outer layer structure 2 remain inside 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, thereby fixing the pressing unit 3 to the support structure 7. The support structure 7 can also be connected to the fixing ring 10, in which case 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, it can drive the fixing ring 10 and the support structure 7 to withdraw synchronously, while only the inner layer structure 1 and the outer layer structure 2 remain inside the body.

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

[0086] Return to reference Figure 9 In an optional example, the support structure 7 is connected to the inner surface of the outer structure 2 facing the pressing unit 3, that is, the support structure 7 is fixed to the outer structure 2. For example, the support structure 7 and the outer 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. When the pressing unit 3 is withdrawn, it can move relative to the support structure 7, while leaving the support structure 7 inside the body.

[0087] In an alternative example, the inner layer structure 1 is a multilayer polymer film, and the support structure 7 can also be placed between the multilayer polymer films of the inner layer structure 1, so as to prevent the support structure 7 from being fixed in the inner layer structure 1 and unable to be smoothly removed from the cavity 4 without interfering with the fastener or the pressing line 61.

[0088] Furthermore, the ventricular assist device includes a first delivery line 81 and a second delivery line 82, as shown in one example, referring to... Figure 10a and Figure 10b As shown, the inner layer structure 1, outer layer structure 2, and pressing unit 3 can all be compressed and transported and implanted in the first delivery conduit 81. (Refer to...) Figure 10aAs shown, after the inner layer structure 1, outer layer structure 2, and pressing unit 3 are released from the constraints of the first delivery conduit 81, the inner layer structure 1 envelops the heart. (Refer to...) Figure 10b As shown, when it is necessary to adjust the position of the pressing unit 3, or when the pressing unit 3 fails and needs to be withdrawn or replaced, the fluid line 32 can be pulled in the direction indicated by arrow b to pull the bag 31 and the fixing ring 10 back into the first delivery line 81 so as to readjust the position of the pressing unit 3 or remove the pressing unit 3 from the body.

[0089] Reference Figures 11a-11c As shown, the support structure 7 is disposed between the pressing unit 3 and the outer structure 2, and the second delivery pipe 82 is connected to the support structure 7. At this time, the support structure 7 is separated from both the outer structure 2 and the pressing unit 3. After the inner structure 1 covers the predetermined object, the support structure 7 moves out of the cavity 4 under the drive of the second delivery pipe 82. In this embodiment, one end of the second delivery pipe 82 extends out of the first delivery pipe 81, and the other end passes through the first delivery pipe 81 and connects to the support structure 7. The fluid pipe 32 passes through the second delivery pipe 82 and connects to the bag 31.

[0090] With this configuration, during implantation, the inner structure 1, outer structure 2, pressing unit 3, support structure 7, and at least part of the second delivery conduit 82 are all compressed within the first delivery conduit 81. After the pressing unit 3 is in place, the first delivery conduit 81 retracts, and the support structure 7 drives the inner structure 1 and outer structure 2 to expand (see reference). Figure 11a After the inner structure 1, outer structure 2, and compression unit 3 are released into place and cover the surface of the heart, the operator can move the support structure 7 into the first delivery tube 81 by pulling the second delivery tube 82 proximally (see reference). Figure 11b The support structure 7, the first delivery pipe 81, and the second delivery pipe 82 are all removed from the body. After the support structure 7 is removed, the fixing ring 10 is fitted over the fluid pipe 32 and delivered into the body along the fluid pipe 32 (see reference). Figure 11c The implantation of the device is completed when the fixation ring 10 is fitted and fixed to the pericardium.

[0091] Reference Figure 12a and Figure 12bIn a preferred embodiment, at least a portion of the outer surface of the inner layer structure 1 is covered with a membrane 91, which preferably covers the bottom of the nearest end of the inner layer structure 1, with a gap (not shown) between the membrane 91 and the inner layer structure 1. The ventricular assist device also includes an injection tubing 92 for injecting a biocompatible adhesive (e.g., bio-adhesive) into the gap. The adhesive can permeate the inner layer structure 1 to bond it to a predetermined object, thereby fixing the inner layer structure 1 to the heart and preventing displacement of the ventricular assist device. Preferably, both the injection tubing 92 and the fluid tubing 32 pass through the fixing ring 10.

[0092] To facilitate the penetration of adhesive through the inner layer structure 1, the inner layer structure 1 is provided with a number of adhesive penetration holes 93 for adhesive penetration. The adhesive penetration holes 93 are connected to the gap, and the adhesive in the gap can enter the space between the inner layer structure 1 and the heart through the adhesive penetration holes 93 to bond the inner layer structure 1 to the outer surface of the heart.

[0093] This application does not impose any particular limitation on the type of driving device. It can be hardware that performs logic operations, such as a microcontroller, microprocessor, programmable logic controller (PLC), or field-programmable gate array (FPGA), or software programs, functional modules, functions, object libraries, or dynamic-link libraries that implement the above functions on a hardware basis. It should be understood how to specifically implement communication between the driving device and other devices.

[0094] In summary, the ventricular assist compression device provided by this invention movably houses the compression unit 3 within the cavity 4 between the inner layer structure 1 and the outer layer structure 2. Thus, when the compression unit 3 fails or needs to be discontinued, if endothelialization occurs in the inner layer structure 1 and the outer layer structure 2, the compression unit 3 can be withdrawn from the cavity 4 and removed from the body. This reduces the amount of material retained in the body, mitigating the impact of retained material on the patient's cardiac function and minimizing interference with the fixation and implantation of subsequent treatment devices.

[0095] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art 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 includes 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 movably disposed 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 a portion of the outer surface of a predetermined object, the compression unit is used to alternately expand and contract, the compression unit presses the predetermined object when it expands, and the compression unit can be removed from the cavity after it stops working and is subjected to a force from the distal end to the proximal end.

2. The ventricular assist compression device as described in claim 1, characterized in that, A fixing member is provided on the outer surface of the inner layer structure facing the pressing unit. The pressing unit is connected to the inner layer structure through the fixing member 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 to the proximal end in the axial direction of the inner layer structure, the pressing unit separates from the inner layer structure and can be moved out of the cavity.

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

4. The ventricular assist compression device as described in claim 2, characterized in that, The fastener has one of a protrusion and a recess, and the pressing unit is provided with the other of the protrusion and the recess. The protrusion is used to engage with the recess to connect the inner layer structure to the pressing unit. The protrusion is also used to deform and disengage from the recess after the pressing unit is subjected to a force in the axial direction of the inner layer structure from the distal end to the proximal end.

5. The ventricular assist compression device as described in claim 1, characterized in that, The inner layer structure and the outer layer structure are stitched together to form a press line, which encloses a second receiving cavity with a second opening; the pressing unit is used to enter and be confined in the second receiving cavity from the second opening, and the pressing unit is also used to remove the second receiving cavity from the second opening.

6. The ventricular assist compression device as described in claim 1, characterized in that, The pressing unit is fixedly connected to the inner layer structure via a biodegradable material; The biodegradable material can degrade after the pressing unit is implanted in the body, thereby separating the pressing unit from the inner layer structure.

7. The ventricular assist compression device as described in claim 1, characterized in that, At least one of the inner layer structure and the outer layer structure consists of at least one layer of polymer film.

8. The ventricular assist compression device as described in claim 1, characterized in that, The pressing unit includes a bladder and a fluid conduit. The bladder is placed in the cavity, and the fluid conduit is connected to the bladder. The fluid conduit is used to inject or extract a working medium into the bladder. The bladder is used to expand after the working medium is injected and to contract after the working medium is extracted. After the bladder expands, it can apply pressing pressure to the predetermined object.

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

10. The ventricular assist compression device as described in claim 8 or 9, characterized in that, It also includes a support structure, which is 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. The expansion of the support structure can drive the release of the inner and outer structures.

11. The ventricular assist compression device as described in claim 10, characterized in that, The support structure is a metal woven mesh or a metal cut bracket. The support structure is disposed 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 it expands.

12. The ventricular assist compression device as described in claim 10, characterized in that, It also includes a fixing ring, the fluid conduit of the pressing unit is connected to the fixing ring; the support structure is connected to the fixing ring; the pressing unit is used to drive the support 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 disposed between the pressing unit and the outer layer structure, and the second delivery pipeline is connected to the support structure. After the inner structure covers the predetermined object, the support structure moves out of the cavity under the drive of the second delivery pipeline.

14. The ventricular assist device as described in any one of claims 1-8, characterized in that, At least a portion 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 further includes an adhesive injection line for injecting adhesive into the gap, the adhesive being able to pass through the inner layer structure to bond the inner layer structure to the predetermined object.

15. The ventricular assist compression device as described in claim 14, characterized in that, The inner layer structure is provided with a plurality of glue penetration holes for glue to pass through, and the glue penetration holes are connected to the gap.

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