A heart assist device

Abstract

The present invention discloses a cardiac assist device, including a catheter and a plurality of support leaves, each of which includes a shell and a flexible bag, the flexible bag is connected to a medium extraction device through a connecting tube, the flexible bag is installed on the shell, and after the medium is injected, the flexible bag can expand and at least partially expose outside the shell; it also includes a guide mechanism and a pushing mechanism, the guide mechanism is used to guide the catheter to insert into the pericardium, the pushing mechanism can drive each of the support leaves to move along the catheter and extend out of the catheter, the shell is made of memory alloy, and in the extended state, each of the support leaves can be unfolded to cover the heart or a specific ventricle. The cardiac assist device provided by the present invention can assist the heart or a specific ventricle to beat, and can further provide auxiliary treatment for patients with heart failure to buy time for heart transplantation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a cardiac assist device for treating heart failure. Background Art

[0002] Heart failure, also known as HF, refers to a condition in which the heart's contractile and / or diastolic function is impaired, which prevents the venous return blood from being fully discharged from the heart, leading to blood congestion in the venous system and insufficient blood perfusion in the arterial system, thus causing cardiac circulatory disorder syndrome. The incidence rate increases year by year with age, seriously affecting people's life safety.

[0003] At present, heart transplantation is one of the most effective methods for treating end-stage heart failure. It can significantly improve the survival rate of patients with end-stage heart failure. The expected one-year survival rate can reach 85%. However, there is a severe shortage of heart donors. Many patients cannot even wait to find a suitable heart, thus missing the opportunity to save their lives.

[0004] Therefore, how to provide a solution to treat or alleviate heart failure and thereby buy time for heart transplantation remains a technical problem that needs to be urgently solved by those skilled in the art. Summary of the invention

[0005] The purpose of the present invention is to provide a cardiac assist device that can assist the heart or a specific ventricle to beat, thereby providing auxiliary treatment for patients with heart failure to buy time for heart transplantation.

[0006] In order to solve the above technical problems, the present invention provides a heart assist device, including a catheter and a plurality of support leaves, each of the support leaves including a shell and a flexible bag, the flexible bag is connected to a medium extraction device through a connecting tube, the flexible bag is installed on the shell, and after the medium is injected, the flexible bag can expand and be at least partially exposed outside the shell; it also includes a guiding mechanism and a pushing mechanism, the guiding mechanism is used to guide the catheter to be inserted into the pericardium, the pushing mechanism can drive each of the support leaves to move along the catheter and extend out of the catheter, the shell is made of memory alloy, and in the extended state, each of the support leaves can be unfolded to cover the heart or a specific ventricle.

[0007] When in use, the catheter can be inserted into the pericardium through the guiding mechanism, and then the support leaf can be pushed out of the catheter through the pushing mechanism. Since the shell of the support leaf is a memory alloy, after the support leaf is extended from the catheter, it can return to its original state to cover the entire heart or a specific ventricle. Then, the medium can be injected and extracted into the flexible bag through the medium extraction device to drive the flexible bag to expand and contract, thereby assisting the heart or a specific ventricle to beat, and further providing auxiliary treatment for patients with heart failure, which can effectively prolong the life of patients with terminal heart failure and buy more time for heart transplant surgery.

[0008] Optionally, in the extended state, each of the support leaves is completely extended out of the conduit.

[0009] Optionally, a chuck is provided at one end of the catheter implanted in the human body, and the chuck is provided with a plurality of guide channels which penetrate axially and are distributed at intervals along the circumferential direction, and the number of the guide channels is the same as the support leaves; in the extended state, each of the support leaves extends out from the corresponding guide channel one by one, and the tail of each of the support leaves remains in the corresponding guide channel.

[0010] Optionally, each of the support leaves is mounted on the conduit, and in a retracted state, each of the support leaves is arranged in sequence along the axial direction in the conduit.

[0011] Optionally, the shell is closed at both longitudinal ends and has an opening on the side wall. The shell has a chamber inside, and the lateral and / or longitudinal dimensions of the chamber are larger than the opening. A portion of the flexible bag is located in the chamber, and the other portion extends out of the chamber from the opening.

[0012] Optionally, the mouth wall of the opening is provided with an outer flange, and the outer flange smoothly transitions with the side wall.

[0013] Optionally, the flexible sac includes a first sac body and a second sac body that are connected to each other, the first sac body is located in the chamber, and the second sac body is located outside the shell; when the medium is injected, the second sac body can expand, and the expanded second sac body presents a wavy shape in the extension direction of the supporting leaf to form a plurality of spaced bulge structures.

[0014] Optionally, a suction cup is provided on the contact surface between the flexible bag and the heart or the specific ventricle, and each of the flexible bags includes a plurality of bulging structures that can swell after a medium is injected.

[0015] Optionally, the medium extraction device is arranged outside the catheter, and the medium to be extracted is gas or liquid; the guiding mechanism includes a puncture needle, a guide wire and an expansion sheath.

[0016] Optionally, a clamp is further included, the clamp comprising a body and a locking portion, the body is fitted onto the catheter and can slide along the catheter, and the locking portion can lock the body onto the catheter.

[0017] Optionally, it also includes a drug injection tube, which can be inserted into the pericardium along the catheter; the outer wall of the catheter is also connected to a spare branch tube, and when in use, the spare branch tube is located outside the human body.

[0018] Optionally, the catheter is inserted into the human body through the chest wall. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the structure of each support leaf of the heart assist device provided by the present invention in an extended state;

[0020] Figure 2 It is a schematic diagram of the structure of each support leaf of the heart assist device provided by the present invention in a retracted state;

[0021] Figure 3 It is a cross-sectional view at the chuck;

[0022] Figure 4 A structural diagram of the connection between each support leaf of the heart assist device provided by the present invention and the heart in an extended state;

[0023] Figure 5 A schematic diagram of the structure of the cardiac assist device provided by the present invention being inserted into the pericardium from the chest wall;

[0024] Figure 6 A partial cross-sectional view of a cardiac assist device during guidewire guidance.

[0025] Figure 1-6 The reference numerals in the figures are described as follows:

[0026] 1 catheter, 11 chuck, 111 guide channel, 12 drug injection tube, 13 spare branch tube;

[0027] 2 supporting leaf, 21 shell, 22 flexible bag, 221 first bag body, 222 second bag body, 222a bulging structure, 23 connecting pipe;

[0028] 3. Guide wire;

[0029] 4. Dilate the sheath. DETAILED DESCRIPTION

[0030] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0031] The term “several” as used herein refers to an indefinite number of multiples, usually more than two; and when “several” is used to indicate the number of certain components, it does not indicate the quantitative relationship between these components.

[0032] Please refer to Figure 1-6 , Figure 1 This is a schematic diagram of the structure of each support leaf of the heart assist device provided by the present invention in an extended state. Figure 2 It is a schematic diagram of the structure of each support leaf of the heart assist device provided by the present invention in a retracted state. Figure 3 is the cross-sectional view at the chuck. Figure 4 This is a structural diagram of the connection between each support leaf of the heart assist device provided by the present invention and the heart in an extended state. Figure 5 This is a schematic diagram of the structure of the cardiac assist device provided by the present invention being inserted into the pericardium from the chest wall. Figure 6 A partial cross-sectional view of a cardiac assist device during guidewire guidance.

[0033] like Figure 1 , Figure 4 As shown, the present invention provides a cardiac assist device, including a catheter 1 and a plurality of support leaves 2, each support leaf 2 including a shell 21 and a flexible bag 22, the flexible bag 22 can be connected to a medium extraction device through a connecting tube 23 (the number is not limited), the flexible bag 22 is installed on the shell 21, and after the medium is injected, the flexible bag 22 can expand and be at least partially exposed outside the shell 21; it also includes a guiding mechanism and a pushing mechanism, the guiding mechanism is used to guide the catheter 1 to insert into the pericardium, the pushing mechanism can drive each support leaf 2 to move along the catheter 1 and extend out of the catheter 1, the shell 21 is made of memory alloy, and in the extended state (working state), each support leaf 2 can be unfolded to cover the heart or a specific ventricle.

[0034] When in use, the catheter 1 can be inserted into the pericardium through the guiding mechanism, and then the support leaf 2 can be pushed out from the catheter 1 through the pushing mechanism. Since the shell 21 of the support leaf 2 is a memory alloy, when the support leaf 2 is extended from the catheter 1, it can return to its original state to cover the entire heart or a specific ventricle. Then, the medium can be injected and extracted into the flexible bag 22 through the medium extraction device to drive the flexible bag 22 to expand and contract, thereby assisting the heart or the specific ventricle to beat, and further providing auxiliary treatment for patients with heart failure, which can effectively prolong the life of patients with terminal heart failure and buy more time for heart transplant surgery.

[0035] Moreover, in the embodiment of the present invention, the component for covering the heart is a plurality of separately arranged support leaves 2. By adjusting the position of each support leaf 2, it is possible to conveniently cover different ventricles. The covering is not limited to the left ventricle or the entire heart, and can adapt to more types of heart diseases.

[0036] The structures of the guiding mechanism and the pushing mechanism can be set with reference to the guiding mechanism and the pushing mechanism of the heart stent in the prior art, and their structures will not be described in detail here.

[0037] by Figure 5 , Figure 6 For reference, in a specific scheme, the guiding mechanism may at least include a puncture needle (not shown in the figure), a guide wire 3 and an expansion sheath 4. The implantation process of the cardiac assist device provided in the embodiment of the present invention is similar to the cardiac stent implantation. First, the puncture needle is inserted into the chest wall (or other positions, such as the radial artery in the arm or the femoral artery in the thigh, etc.), and then the guide wire 3 is passed through the internal channel of the puncture needle, and the guide wire 3 is moved to the designated position with the assistance of the angiographic device. Subsequently, the expansion sheath 4 is inserted, and the catheter 1 is inserted into the pericardium along the guide wire. After that, the support leaf 2 in the catheter 1 can be extended from the front end of the catheter 1 (the end inserted into the human body) through the pushing mechanism to complete the operation.

[0038] In the first option, if Figure 3 As shown, the front end of the catheter 1 can be provided with a chuck 11, and the chuck 11 can be provided with a plurality of guide channels 111 that penetrate axially and are distributed at intervals along the circumferential direction. The number of the guide channels 111 can be the same as the support leaves 2; in the extended state, each support leaf 2 can be extended one by one from the corresponding guide channel 111, and the tail of each support leaf 2 can be retained in the corresponding guide channel 111.

[0039] With such arrangement, each support leaf 2 can still establish connection with the clamp 11 by relying on the relatively strong shell 21 when extended, which can improve the connection strength between each support leaf 2 and the catheter 1, thereby ensuring the structural strength of the entire device in the working state.

[0040] In the second solution, the front end of the catheter 1 may not be provided with the aforementioned clamp 11. In the extended state, each support leaf 2 may also be completely extended out of the catheter 1. At this time, each support leaf 2 is only connected to the catheter 1 through its own connecting tube 23.

[0041] Since the radial dimension of the connecting tube 23 is much smaller than that of the supporting leaf 2, by adopting this solution, the front end dimension of the catheter 1 can be smaller, and the internal dimension of the catheter 1 only needs to be able to meet the needs of a single passage of a supporting leaf 2. This makes the radial dimension of the catheter 1 much smaller than that of the first solution, which can greatly reduce the trauma area, alleviate the patient's pain, and facilitate the patient's rapid recovery after surgery.

[0042] In comparison, the incision caused by the second solution is smaller, which is more conducive to achieving minimally invasive surgery and is the preferred solution of the embodiment of the present invention.

[0043] Each of the support leaves 2 can be directly installed in the conduit 1. In this case, the conduit 1 can not only serve as a guide channel for the support leaves 2, but also bear the function of storing the support leaves 2. Figure 2 As shown, in order to reduce the radial dimension of the catheter 1, in the retracted state, the support leaves 2 can be arranged sequentially along the extension direction of the catheter 1.

[0044] In addition, each support leaf 2 can also be an independent component, and then implanted one by one into the catheter 1 during the operation. At this time, the implantation process of the support leaf 2 is consistent with the implantation process of the heart stent. The catheter 1 only serves as a guide channel, and the radial dimension of the catheter 1 must at least meet the requirements of a single passage of one support leaf 2.

[0045] The connection structure between the shell 21 and the flexible bag 22 can be varied, as long as the reliable connection between the two can be ensured, and the flexible bag 22 can smoothly expand and contract during the medium extraction process, thereby assisting the heart to beat. For example, the flexible bag 22 and the shell 21 can be bonded and fixed, in which case, the structure of the shell 21 itself is not limited, as long as a suitable adhesive is selected.

[0046] like Figure 1 As shown, the shell 21 can be a long strip structure, both ends of which can be closed, and the circumferential side walls can be provided with openings. A chamber can be formed in the shell 21. For the convenience of expression, the extension direction of the shell 21 (i.e., the supporting leaf 2) can be longitudinal, and on the leaf surface of the supporting leaf 2, the direction perpendicular to the longitudinal direction can be transverse. The transverse and / or longitudinal dimensions of the chamber can be larger than the opening to form a necking structure. A part of the flexible bag 22 can be in the chamber, and the other part can extend out of the chamber from the opening. Due to the setting of the necking structure, the circumferential side walls of the shell 21 can limit the flexible bag 22 located in the chamber to confine the flexible bag 22 in the shell 21.

[0047] Specifically, it can be combined with Figure 3 The cross-section of the shell 21 at the opening position can be roughly U-shaped, and the two side walls of the U-shape can gradually tilt inward from the direction away from the bottom wall to form the aforementioned shrinkage structure.

[0048] Furthermore, the mouth wall of the opening may be provided with an outer flange, and a smooth transition may be provided between the outer flange and the side wall. Such a configuration may avoid the formation of a sharp structure, thereby avoiding cutting damage to the inflated flexible bag 22, and is beneficial to extending the service life of the flexible bag 22.

[0049] The flexible capsule 22 may include a first capsule body 221 and a second capsule body 222 that are connected, and due to the setting of the aforementioned shrinkage structure, the lateral size of the connecting portion of the first capsule body 221 and the second capsule body 222 is smaller than that of the first capsule body and the second capsule body, so that the first capsule body can be snapped into the shell 21 (it can also be fixed by bonding or other methods at the same time); after the medium is injected, the first airbag 221 and the second airbag 222 can expand, and the second airbag 222 can be located outside the shell 1. It can be understood that the flexible capsule 22 of this structure mainly assists the heart or a specific ventricle to beat by the expansion and contraction of the second airbag 222.

[0050] In the extension direction of the supporting leaf 2, Figure 1 As shown, the expanded second sac 222 can be wavy to form spaced bulge structures 222a. With this arrangement, each flexible sac 22 can exert multi-point pressure on the heart or a specific ventricle, which is more conducive to assisting the beating of the heart or a specific ventricle.

[0051] The contact surface between the flexible bag 22 and the heart or a specific ventricle may also be provided with a suction cup to ensure that the flexible bag 22 and the heart or a specific ventricle are closely fitted, so that the expansion and contraction of the flexible bag 22 can better act on the heart or the specific ventricle.

[0052] The medium extraction device may specifically include a pump body and a medium bin, and the medium bin is used to store the medium to be extracted, and the medium may be a gas or a liquid, etc. The medium extraction device may be arranged outside the catheter 1. When the patient is in bed, the medium extraction device may be placed on one side of the bed, and when the patient goes out, the medium extraction device may be placed in a backpack and carried by the patient. Here, the embodiment of the present invention does not limit the pressure of the medium in the medium bin and the power of the pump body, etc., as long as it is ensured that under the action of the medium extraction device, the flexible bag 22 can be expanded and contracted smoothly, thereby assisting the heart or a specific ventricle to beat.

[0053] Still Figure 3 As shown, a drug injection tube 12 can also be included. The drug injection tube 12 can be inserted into the pericardium along the catheter 1 so that therapeutic drugs can be injected into the pericardium through the drug injection tube 12. Compared with taking medicine or injections, this method allows the therapeutic drugs to reach the designated location more quickly, which is more conducive to the treatment of the affected area.

[0054] The outer wall of the catheter 1 may also be connected to a spare branch pipe 13, and in the working state, the spare branch pipe 13 may be located outside the human body.

[0055] For ease of description, the front end opening of the conduit 1 can be the outlet of the conduit 1, and the rear end opening of the conduit 1 can be the inlet of the conduit 1. Then, the above-mentioned spare branch pipe 13 is actually equivalent to setting multiple inlets for the conduit 1. When one of the inlets cannot be used, other inlets can be used. It can be understood that the number of the above-mentioned spare branch pipes 13 is not limited to one, but can also be multiple, which can be determined according to actual needs.

[0056] Combination Figure 5 , Figure 6 The cardiac assist device provided by the present invention can be implanted from the chest wall. Compared with the traditional cardiac stent implantation method of implanting from the radial artery of the arm or the femoral artery of the thigh, the implantation method from the chest wall can avoid blood contact to minimize the risk of blood infection. Moreover, the implantation path is much shorter, the time of the implantation operation can be greatly reduced, and the difficulty of the operation can also be greatly reduced.

[0057] It should be noted that the chest wall implantation method is the preferred solution of the embodiment of the present invention, but it is not the only solution. In fact, the heart assist device provided by the present invention can also be implanted through the radial artery of the arm or the femoral artery of the thigh, which does not affect the realization of the function of the heart assist device provided by the present invention.

[0058] Furthermore, a clamp (not shown in the figure) may be included. The clamp may include a main body and a locking part. The main body may be annular and is sleeved on the catheter 1. The main body may slide along the catheter 1. When the cardiac assist device provided by the present invention is installed in place, the locking part may be operated. The locking part may specifically be a screw, etc., which can lock the main body on the catheter 1 and make the main body fit against the chest wall. Such a setting is equivalent to providing a support point for the catheter 1, which can largely prevent the catheter 1 from shaking and causing further damage to the insertion port on the chest wall.

[0059] In addition, in the drawings of the embodiments of the present invention, the catheter 1 appears in the form of a round tube, but in fact, the catheter 1 is not necessarily a round tube, it can also be a square tube, a flat tube, etc., as long as it can be successfully implanted in the human body and meet the functions of smooth passage of each supporting leaf 2. In other words, the shape of the catheter 1 cannot be used as a limitation on the scope of implementation of the heart assist device provided by the present invention.

[0060] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A cardiac assist device, characterized in that: The device comprises a catheter (1) and a plurality of support leaves (2), each of the support leaves (2) comprising a shell (21) and a flexible bag (22), the flexible bag (22) being connected to a medium pumping device via a connecting pipe (23), the flexible bag (22) being mounted on the shell (21), and after the medium is injected, the flexible bag (22) is able to expand and at least partially be exposed outside the shell (21); It also includes a guiding mechanism and a pushing mechanism, wherein the guiding mechanism is used to guide the catheter (1) to be inserted into the pericardium, and the pushing mechanism can drive each of the supporting leaves (2) to move along the catheter (1) and extend out of the catheter (1), and the shell (21) is made of a memory alloy, and in the extended state, each of the supporting leaves (2) can be unfolded to cover the heart or a specific ventricle, so that the flexible bag (22) is in contact with the heart or the specific ventricle; Each of the support leaves (2) is mounted on the conduit (1), and in a retracted state, each of the support leaves (2) is sequentially arranged in the conduit (1) along the axial direction; The medium extraction device is arranged outside the catheter (1), and the medium to be extracted is gas or liquid; the guiding mechanism comprises a puncture needle, a guide wire (3) and an expansion sheath (4).

2. The cardiac assist device according to claim 1, characterized in that: In the extended state, each of the support leaves (2) is completely extended out of the conduit (1).

3. The cardiac assist device according to claim 1, characterized in that: One end of the catheter (1) implanted in the human body is provided with a clamp (11), the clamp (11) being provided with a plurality of guide channels (111) penetrating in the axial direction and distributed at intervals in the circumferential direction, the number of the guide channels (111) being the same as the number of the support leaves (2); In the extended state, each of the support leaves (2) extends out from the corresponding guide channel (111) in a one-to-one correspondence, and the tail of each of the support leaves (2) remains in the corresponding guide channel (111).

4. The cardiac assist device according to any one of claims 1 to 3, characterized in that: The shell (21) is closed at both longitudinal ends, and has an opening on its side wall. The shell (21) has a chamber inside, and the transverse and / or longitudinal dimensions of the chamber are larger than the opening. A portion of the flexible bag (22) is located in the chamber, and another portion extends out of the chamber from the opening.

5. The cardiac assist device according to claim 4, characterized in that: The mouth wall of the opening is provided with an outer flange, and the outer flange smoothly transitions with the side wall.

6. The cardiac assist device according to claim 4, characterized in that: The flexible capsule (22) comprises a first capsule body (221) and a second capsule body (222) which are connected to each other, wherein the first capsule body (221) is located in the chamber, and the second capsule body (222) is located outside the shell (21); When the medium is injected, the second sac (222) is able to expand, and the expanded second sac (222) presents a wave shape in the extension direction of the support leaf (2) to form a plurality of spaced bulge structures (222a).

7. The cardiac assist device according to any one of claims 1 to 3, characterized in that: A suction cup is provided on the contact surface between the flexible bag (22) and the heart or the specific ventricle, and each of the flexible bags (22) comprises a plurality of bulging structures (222a) that can bulge after a medium is injected.

8. The cardiac assist device according to any one of claims 1 to 3, characterized in that: It also comprises a clamp, the clamp comprising a body and a locking portion, the body being fitted onto the catheter (1) and being able to slide along the catheter (1), and the locking portion being able to lock the body onto the catheter (1).

9. The cardiac assist device according to any one of claims 1 to 3, characterized in that: It also includes a drug injection tube (12), which can be inserted into the pericardium along the catheter (1); The outer wall of the catheter (1) is also connected to a spare branch tube (13); when in use, the spare branch tube (13) is located outside the human body.

10. The cardiac assist device according to any one of claims 1 to 3, characterized in that: The catheter (1) is inserted into the human body through the chest wall.

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