Integrated structure double-ventricle independent auxiliary device and implantation method

Abstract

The invention provides an integrated structure double-ventricle independent auxiliary device and an implantation method. The device comprises double inlet paths and double outlet paths which are connected, the double inlet paths are of a double-cavity structure and comprise an inner cavity and an outer cavity, the double inlet paths are implanted through the apex of the left ventricle, the inner cavity is inserted into the apex of the funnel of the right ventricle through the corresponding ventricular septum at the opening of the left ventricle, and the outer cavity is reserved in the left ventricle; and the double outlets are respectively connected with the aorta and the pulmonary artery through the artificial blood vessel by a circulation driving device. Left and right artificial ventricle admission passages are located in the heart, and channel distortion, large blood damage and proneness to thrombus caused by long admission passages are avoided; unsmooth drainage of a right chamber or right ventricle admission passage can be avoided; the right chamber is not damaged; the whole device is small in size and convenient to implant.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an integrated biventricular independent assist device and an implantation method thereof. Background Art

[0002] The left ventricular assist device (LVAD) is an artificial life support device for patients with acute left heart failure who cannot be saved by short-term percutaneous assistance, and for patients with mid- to late-stage left heart failure who need heart transplantation. After several generations of improvements, the LVAD has become the third-generation magnetically suspended artificial left ventricular assist device. Its principle is that a mechanical pump connects the left ventricle and the ascending aorta, partially or completely replacing the left ventricular pump function to achieve mid- to long-term life support. Existing products have defects: 1. Autologous heart damage. 2. Lifelong anticoagulation. 3. Poor tissue compatibility. 4. Impact on right heart function, leading to right heart failure, affecting the effect of life support. 5. It cannot be used for patients with total heart failure. There is currently no simple implantable and effective whole-heart mechanical assist device.

[0003] SynCardia is currently the only full-heart mechanical assist device in the world that is most likely to be close to clinical use. However, its implantation surgery is complicated, and once implanted it cannot be removed, and its effectiveness remains to be proven. There are two other biventricular assist devices to be developed. The principle is to replace the left and right ventricles with two sets of currently used LVADs. There are two connection methods for right heart assist. 1. The inlet is the right ventricle and the outlet is the pulmonary artery. 2. The inlet is the right atrium and the outlet is the pulmonary artery, that is, RVAD. Its working principle is exactly the same as that of LVAD. The effect of the combined use of this RVAD and LVAD has not yet been proven. But in theory, it is extremely unreasonable to use the anatomical characteristics of the right ventricle and a low-pressure cavity in the right atrium as the inlet. Summary of the invention

[0004] In response to the technical problems raised above, an integrated biventricular independent assist device and an implantation method are provided.

[0005] The technical means adopted by the present invention are as follows:

[0006] A one-piece biventricular independent assist device comprises: a dual inlet and a dual outlet connected to each other, wherein the dual inlet has a dual-chamber structure, including an inner chamber and an outer chamber, the dual inlet is implanted through the left ventricle, the inner chamber is inserted into the right ventricle, and the outer chamber is inserted into the left ventricle, and the dual outlet is respectively connected to the aorta and the pulmonary artery through a circulation drive device.

[0007] Furthermore, a first stoma is opened on the outer wall of the left ventricle, a second stoma is opened on the interventricular septum between the right ventricle and the left ventricle, the outer cavity is fixed at the first stoma and inserted into the left ventricle through the first stoma, and the inner cavity is inserted into the right ventricle through the left ventricle and the second stoma in sequence.

[0008] Furthermore, the first stoma is close to the apex of the left ventricle, and the second stoma is close to the apical interventricular septum between the right ventricle and the left ventricle, and the apical interventricular septum is the interventricular septum between the infundibulum apex of the right ventricle and the apex of the left ventricle.

[0009] Furthermore, the inner cavity is long and curved in an arc shape, and the outer cavity is short and is entirely located outside the inner cavity.

[0010] Furthermore, one end of the inner cavity is inserted into the infundibulum of the right ventricle through the interventricular septum at the apex position of the infundibulum of the right ventricle, and the other end passes through the outer cavity and is connected to the circulation driving device.

[0011] Furthermore, the circulation drive device includes a first pump and a second pump, the first pump is connected to the outer cavity, and the second pump is connected to the inner cavity.

[0012] Furthermore, the first pump is connected to the aorta through a first artificial blood vessel, and the second pump is connected to the pulmonary artery through a second artificial blood vessel.

[0013] Furthermore, the first pump and the second pump are both magnetic levitation pumps.

[0014] The present invention also provides a method for implanting an integrated biventricular independent assist device, comprising the following steps:

[0015] Step 1: After punching a hole near the apex of the left ventricle to form a first stoma, puncture the second stoma in the apical ventricular septum of the right ventricular infundibulum, and implant the inner cavity to the right ventricular infundibulum without suturing;

[0016] Step 2: After the positions of the left and right ventricular artificial heart inflow tracts are determined, the outer cavity is sutured and fixed at the first stoma;

[0017] Step 3, the outflow pipes of the double outlets are respectively anastomosed with the aorta and the pulmonary artery, wherein the first pump and the second pump of the circulation drive device are respectively connected to the aorta and the pulmonary artery through the first artificial blood vessel and the second artificial blood vessel;

[0018] Step 4, start the first and second pumps on the left and right sides to complete biventricular assist;

[0019] Step 5: The first pump and the second pump corresponding to the left and right ventricles work independently, and adjust their respective parameters according to the functions of the left and right ventricles to maintain systemic circulation and pulmonary circulation.

[0020] Compared with the prior art, the present invention has the following advantages:

[0021] 1. This invention is the world's first applicable biventricular assist device design.

[0022] 2. The left and right artificial ventricle accesses of the present invention are both located inside the heart, thus avoiding long accesses that lead to channel distortion, severe blood damage, and susceptibility to thrombosis.

[0023] 3. The present invention can avoid poor drainage in the right atrium or right ventricle.

[0024] 4. The present invention does not cause any damage to the right ventricle.

[0025] 5. The overall device of the present invention is small in size and easy to implant.

[0026] Based on the above reasons, the present invention can be widely promoted in the fields of medicine and the like. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0028] Figure 1 This is a schematic diagram of the device of the present invention after implantation.

[0029] Figure 2 It is a schematic diagram of the structure of the device of the present invention.

[0030] Figure 3 for Figure 2 Split diagram of .

[0031] In the figure: 1. right ventricle; 2. inner cavity; 3. first stoma; 4. second stoma; 5. first pump; 6. second pump; 7. outer cavity; 8. left ventricle; 9. second artificial blood vessel; 10. pulmonary artery; 11. aorta; 12. first artificial blood vessel. DETAILED DESCRIPTION

[0032] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0033] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0034] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprising" and / or "including" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0035] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps set forth in these embodiments do not limit the scope of the present invention. Meanwhile, it should be clear that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, method and equipment known to those of ordinary skill in the relevant art may not be discussed in detail, but in appropriate cases, the technology, method and equipment should be considered as a part of the specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, and therefore, once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0036] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention: the directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0037] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below their position devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0038] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0039] The present invention provides an integrated biventricular independent assist device. The present invention is the world's only biventricular assist device (DVAD) based on the principle of magnetic levitation: two sets of miniaturized magnetic levitation pump bodies are integrated into one body. The main linlet is exactly the same as the current LVAD implantation location and implantation method, and the outlets are connected to the aorta and pulmonary artery respectively. The two sets of magnetic levitation pumps work independently. The working parameters can be set according to the left and right ventricular functions, the degree of assistance required for systemic circulation and pulmonary circulation, and can be changed to single ventricular assistance or stopped at any time. The DVAD structure of the present invention (see Figure 1-3 ): The main inlet is a double-chamber structure, with a long and curved inner lumen, which extends into the right ventricular outflow tract through the ventricular septum of the right ventricular infundibulum to avoid interference with the functional right ventricular structure and obstruction of the entrance during unloading. The outer lumen is short and located outside the inner lumen. It is fixed to the apex of the left ventricle, exactly the same as LVAD. The double inlets enter their respective pumps. The outlets are connected to the aorta and pulmonary artery through artificial blood vessels.

[0040] Example 1

[0041] The present invention provides an integrated biventricular independent assist device, comprising: a dual inlet and a dual outlet connected to each other, the dual inlet having a dual-chamber structure, comprising an inner chamber 2 and an outer chamber 7, the dual inlet being implanted through the apex of the left ventricle 8, the inner chamber 2 being inserted through the ventricular septum corresponding to the opening of the left ventricle to the apex of the funnel of the right ventricle 1, the outer chamber 7 being inserted and remaining in the left ventricle 8, the dual outlets respectively exiting from the left and right ventricular assist devices and respectively connected to the aorta 11 and the pulmonary artery 10, the dual outlets being respectively connected to the aorta 11 and the pulmonary artery 10 through an artificial blood vessel via a circulation drive device.

[0042] In this embodiment, a first stoma 3 is formed on the outer wall of the left ventricle 8, a second stoma 4 is formed on the interventricular septum between the right ventricle 1 and the left ventricle 8, the outer cavity 7 is fixed at the first stoma 3 and inserted into the left ventricle 8 through the first stoma 3, and the inner cavity 2 is inserted into the right ventricle 1 through the left ventricle 8 and the second stoma 4 in sequence. The first stoma 3 is close to the apex of the left ventricle 8, and the second stoma 4 is close to the apex interventricular septum between the right ventricle 1 and the left ventricle 8, which is the interventricular septum between the apex of the funnel of the right ventricle 1 and the apex of the left ventricle 8.

[0043] In this embodiment, the inner cavity 2 is long and curved, and the outer cavity 7 is short and entirely located outside the inner cavity 2. One end of the inner cavity 2 is inserted into the infundibulum of the right ventricle 1 through the interventricular septum at the apex of the infundibulum of the right ventricle 1, and the other end passes through the outer cavity 7 and is connected to the circulation drive device.

[0044] In this embodiment, the circulation drive device includes a first pump 5 and a second pump 6, the first pump 5 is connected to the outer cavity 7, and the second pump 6 is connected to the inner cavity 2. The first pump 5 is connected to the aorta 11 through the first artificial blood vessel 12, and the second pump 6 is connected to the pulmonary artery 10 through the second artificial blood vessel 9. The first pump 5 and the second pump 6 are both magnetic levitation pumps.

[0045] Features of the present invention: 1. Biventricular assistance, but there is only one entrance at the apex of the left ventricle on the surface of the heart, and only one suture is needed for the heart during biventricular assistance. 2. The ventricular septum stoma is used as the entrance of the right ventricle, and the stoma site is located at the apex of the anatomical right ventricular outflow tract. 3. The right ventricular unloading port is implanted by direct puncture of the ventricular septum, and no suturing is required (the ventricular septum stoma does not require suturing). 4. The right ventricular entrance is located in the right ventricular outflow tract, without interference from the intracardiac structure. 5. The right ventricular entrance of the artificial heart is located at the apex of the infundibulum, keeping the functional right ventricular structure intact. 6. The anatomical structure of the infundibulum is simple, avoiding interference from the internal structure of the right ventricle. 7. The right ventricular unloading entrance is located inside the heart, with the shortest stroke, reducing blood damage and thrombosis. 8. Direct unloading of the right ventricle is more convenient for drainage than unloading of the right atrium. 9. The left and right artificial ventricular inflow tracts are double-chamber structures inside the heart, and the extracardiac part is divided into left and right ventricular centrifugal pumps, each with an independent control system. 10. The outflow tracts are respectively anastomosed with the main pulmonary artery.

[0046] Example 2

[0047] Method of use of the present invention: The surgical steps are similar to those of current LVAD implantation. The main pump is located outside the apex and above the diaphragm, and the need for an artificial bag is determined by the size of the pump body. The left ventricle stoma and suturing are exactly the same as those of LVAD implantation. Puncture the left ventricle stoma corresponding to the ventricular septum of the lower right ventricular infundibulum, and implant the inner cavity channel into the right ventricular outflow tract without suturing or fixation. The outlets of the left and right ventricular assist pumps are respectively anastomosed to the ascending aorta and the pulmonary artery trunk through artificial blood vessels. Start the left and right artificial heart pumps to complete biventricular assistance. The left and right ventricular pumps work independently, and their respective parameters can be adjusted according to the function of the left and right ventricles to maintain systemic and pulmonary circulation.

[0048] The present invention provides a method for implanting an integrated biventricular independent assist device, specifically comprising:

[0049] Step 1, after punching a hole near the apex of the left ventricle 8 to form a first stoma 3, puncture the second stoma 4 of the apical ventricular septum of the infundibulum of the right ventricle 1, and implant the right ventricular inflow port (inner cavity 2) of the artificial heart to the infundibulum of the right ventricle 1, and no suture is required at the second stoma 4;

[0050] Step 2: After the left and right ventricular artificial heart inflow channels are determined to be in normal positions, the external cavity 7 is sutured and fixed at the first stoma 3;

[0051] Step 3, the outflow pipe is respectively anastomosed with the aorta 11 and the pulmonary artery 10, wherein the first pump 5 and the second pump 6 of the circulation drive device are respectively connected to the aorta 11 and the pulmonary artery 10 through the first artificial blood vessel 12 and the second artificial blood vessel 9;

[0052] Step 4, start the left and right artificial heart pumps (the first pump 5 and the second pump 6) to complete biventricular assistance;

[0053] Step 5: The left and right ventricular pumps (the first pump 5 and the second pump 6) work independently and can adjust their respective parameters according to the left and right ventricular functions to maintain systemic circulation and pulmonary circulation.

[0054] The product design advantages of the present invention are as follows: 1. The present invention is the world's first applicable biventricular assist device. 2. The assist device enters the heart through a conventional left ventricular entrance, and the left and right artificial ventricular access routes are both located inside the heart, making implantation simple; avoiding long access routes that lead to channel distortion, severe blood damage, and susceptibility to thrombosis. 3. Avoiding incomplete unloading of the right ventricle due to poor drainage of the right atrium or right ventricle. 4. No damage or destruction to the functional right ventricle. 5. The overall device is small in size and is easy to implant in the body. 6. Depending on the recovery of left and right ventricular function, the assist can be removed separately or completely. It is the world's only operable, high-efficiency, full-heart assist, and removable DVAD.

[0055] Features of the present invention: 1. Biventricular assist, the connection between the assist device and the heart surface is the same as the current LVAD, that is, dual inlet and single connection, to achieve the minimum overall volume of the artificial biventricle. 2. The ventricular septum stoma serves as the inlet of the artificial right ventricle. The stoma site is at the apex of the anatomical right ventricular infundibulum, and the free wall of the right ventricle is not damaged, providing the possibility of removing right heart assist. 3. The ventricular septum stoma does not require suturing, and the surgical operation is simple. 4. The artificial right ventricular inlet is located in the right ventricular outflow tract, without interference from the intracardiac structure; the opening direction is parallel to the right ventricular outflow tract, which is convenient for full unloading of the right ventricle. 5. The left and right artificial ventricular inflow tracts are a double-chamber structure inside the heart, and the extracardiac part is divided into left and right ventricular pump bodies, each independently controlling the flow rate. 6. The outflow tracts are respectively anastomosed with the main pulmonary arteries.

[0056] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An integrated biventricular independent assist device, characterized in that: include: A double inlet and a double outlet are connected, the double inlet has a double chamber structure, including an inner chamber (2) and an outer chamber (7), the double inlet is implanted through the left ventricle (8), the inner chamber (2) is inserted into the right ventricle (1), and the outer chamber (7) is inserted into the left ventricle (8), and the double outlet is respectively connected to the aorta (11) and the pulmonary artery (10) through a circulation drive device.

2. The integrated biventricular independent assist device according to claim 1, characterized in that: A first stoma (3) is formed on the outer wall of the left ventricle (8), a second stoma (4) is formed on the interventricular septum between the right ventricle (1) and the left ventricle (8), the outer cavity (7) is fixed at the first stoma (3) and inserted into the left ventricle (8) through the first stoma (3), and the inner cavity (2) is inserted into the right ventricle (1) through the left ventricle (8) and the second stoma (4) in sequence.

3. The integrated biventricular independent assist device according to claim 2, characterized in that: The first stoma (3) is close to the apex of the left ventricle (8), and the second stoma (4) is close to the apex interventricular septum between the right ventricle (1) and the left ventricle (8), wherein the apex interventricular septum is the interventricular septum between the infundibulum apex of the right ventricle (1) and the apex of the left ventricle (8).

4. The integrated biventricular independent assist device according to claim 1, characterized in that: The inner cavity (2) is long and curved in an arc shape, and the outer cavity (7) is short and is entirely located outside the inner cavity (2).

5. The integrated biventricular independent assist device according to claim 1, characterized in that: One end of the inner cavity (2) is inserted into the funnel of the right ventricle (1) through the interventricular septum at the apex of the funnel of the right ventricle (1), and the other end passes through the outer cavity (7) to be connected to the circulation drive device.

6. The integrated biventricular independent assist device according to claim 1, characterized in that: The circulation drive device comprises a first pump (5) and a second pump (6), wherein the first pump (5) is connected to the outer chamber (7), and the second pump (6) is connected to the inner chamber (2).

7. The integrated biventricular independent assist device according to claim 6, characterized in that: The first pump (5) is connected to the aorta (11) via a first artificial blood vessel (12), and the second pump (6) is connected to the pulmonary artery (10) via a second artificial blood vessel (9).

8. The integrated biventricular independent assist device according to claim 6 or 7, characterized in that: The first pump (5) and the second pump (6) are both magnetic levitation pumps.

9. A method for implanting the integrated biventricular independent assist device according to any one of claims 1 to 8, characterized in that: The steps include: Step 1, after punching a hole near the apex of the left ventricle (8) to form a first stoma (3), puncture the second stoma (4) of the apical ventricular septum of the infundibulum of the right ventricle (1), and implant the inner cavity (2) into the infundibulum of the right ventricle (1) without suturing; Step 2: After the positions of the left and right ventricular artificial heart inflow tracts are determined, the outer cavity (7) is sutured and fixed at the first stoma (3); Step 3, the outflow pipes of the double outlets are respectively anastomosed with the aorta (11) and the pulmonary artery (10), wherein the first pump (5) and the second pump (6) of the circulation drive device are respectively connected to the aorta (11) and the pulmonary artery (10) through the first artificial blood vessel (12) and the second artificial blood vessel (9); Step 4, starting the left and right first pumps (5) and the second pumps (6) to complete biventricular assistance; Step 5: The first pump (5) and the second pump (6) corresponding to the left and right ventricles work independently, and adjust their respective parameters according to the functions of the left and right ventricles to maintain systemic circulation and pulmonary circulation.

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