Integrated structure double-ventricle independent auxiliary device

Abstract

The utility model provides an integrated structure double-ventricle independent auxiliary device, which comprises a double inlet path and a double outlet path which are connected with each other, the double inlet path is provided with a double-cavity structure and comprises an inner cavity and an outer cavity, the double inlet path is implanted through the apex of a left ventricle, the inner cavity is inserted into the apex of a right ventricle funnel through a 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 positioned in the heart, so that channel distortion, great 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] This utility model relates to the field of medical device technology, and more specifically, to an integrated dual ventricle independent auxiliary device. Background Technology

[0002] Left ventricular assist devices (LVADs) are currently used for patients with acute left heart failure for whom short-term percutaneous transcatheter aortic intervention is insufficient, and for patients with mid-to-late-stage left heart failure who require heart transplantation. After several generations of improvements, the current third-generation magnetically levitated LVAD has been developed. Its principle involves a mechanical pump connecting the left ventricle to the ascending aorta, partially or completely replacing the left ventricular pump function to provide medium- to long-term life support. Existing products have the following drawbacks: 1. Damage to the patient's own heart. 2. Lifelong anticoagulation. 3. Poor tissue compatibility. 4. Impact on right ventricular function, leading to right heart failure and affecting the effectiveness of life support. 5. Unusable for patients with total heart failure; currently, there is no simple, effective, and comprehensive mechanical assist device for the entire heart.

[0003] SynCardia is currently the only fully functional cardiac assist device globally that is most likely to be clinically viable. However, its implantation surgery is complex, and once implanted, it cannot be removed; its effectiveness also remains to be proven. There are two other biventricular assist devices under development, both of which replace the left and right ventricles with two currently used LVADs. There are two connection methods for right ventricular 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, i.e., RVAD. Its working principle is exactly the same as LVAD. The effectiveness of using RVAD in combination with LVAD has not yet been proven. However, theoretically, using the right ventricle's anatomical characteristics and the right atrium's single low-pressure chamber as the inlet is highly unreasonable. Utility Model Content

[0004] In response to the aforementioned technical problems, an integrated dual-ventricle independent auxiliary device is provided.

[0005] The technical means adopted in this utility model are as follows:

[0006] An integrated dual ventricular independent cardiac assist device includes: two connected inlet and two outlet pathways. The two inlet pathways have a dual-chamber structure, including an inner chamber and an outer chamber. The two inlet pathways are implanted through the left ventricle, the inner chamber is inserted into the right ventricle, and the outer chamber is inserted into the left ventricle. The two outlet pathways are connected to the aorta and pulmonary artery respectively through a circulatory drive device.

[0007] Furthermore, a first stoma is opened on the outer wall of the left ventricle, and a second stoma is opened on the interventricular septum between the right and left ventricles. The external cavity is fixed at the first stoma and inserted into the left ventricle through the first stoma, and the internal cavity is inserted into the right ventricle sequentially through the left ventricle and the second stoma.

[0008] Furthermore, the first stoma is located near the apex of the left ventricle, and the second stoma is located near the apical interventricular septum between the right and left ventricles. This apical interventricular septum is the interventricular septum between the infundibulum of the right ventricle and the apex of the left ventricle.

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

[0010] Furthermore, one end of the inner cavity is inserted into the infundibulum of the right ventricle via the interventricular septum at the apex of the right ventricle, while the other end extends out of the outer cavity and connects to the circulation drive device.

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

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

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

[0014] This utility model also provides a method for implanting an integrated biventricular assist device, comprising the following steps:

[0015] Step 1: After making a hole near the apex of the left ventricle to form the first stoma, puncture the second stoma in the apical interventricular septum of the right ventricle in the infundibulum and implant it into the infundibulum of the right ventricle without suturing.

[0016] Step 2: After determining the location of the left and right ventricular artificial heart inflow tracts, the external cavity is sutured and fixed at the first stoma.

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

[0018] Step 4: Activate the left and right first and second pumps to complete biventricular assist;

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

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

[0021] 1. This utility model is the world's first design applicable to biventricular assist devices.

[0022] 2. In this invention, both the left and right artificial ventricles are located inside the heart, avoiding the problems of long access routes leading to channel distortion, significant blood disruption, and increased thrombosis.

[0023] 3. This utility model can avoid poor drainage in the right atrium or right ventricle.

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

[0025] 5. The overall size of this utility model device is small and easy to implant.

[0026] Based on the above reasons, this utility model can be widely promoted in fields such as medicine. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the device after it has been implanted.

[0029] Figure 2 This is a schematic diagram of the structure of the device of this utility model.

[0030] Figure 3 for Figure 2 The split diagram.

[0031] In the diagram: 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 Implementation

[0032] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0033] This invention provides an integrated dual ventricle assist device (DVAD), the world's only magnetically levitated dual ventricle assist device (DVAD): It features miniaturized two magnetically levitated pump bodies integrated into a single unit. The main lint is identical to current LVAD implantation sites in terms of location and method, while the outlets connect to the aorta and pulmonary artery respectively. The two magnetically levitated pumps operate independently. Operating parameters can be set according to the function of the left and right ventricles, and the required level of assistance in systemic and pulmonary circulation, allowing for immediate switching to single ventricle assistance or discontinuation of assistance. The structure of this DVAD (see...) Figure 1-3 The main inlet is a dual-lumen structure. The inner lumen is long and curved, extending into the right ventricular outflow tract through a ventricular septal incision in the right ventricular infundibulum, avoiding interference with functional right ventricular structures and inlet obstruction during unloading. The outer lumen is short, located entirely outside the inner lumen, and fixed to the apex of the left ventricular cavity, identical to the LVAD. The two inlets enter their respective pumps. The outlets are connected to the aorta and pulmonary artery via artificial blood vessels.

[0034] Example 1

[0035] This utility model discloses an integrated dual-ventricle independent cardiac assist device, comprising: two connected inlet and two outlet channels. The two inlet channels have a dual-chamber structure, including an inner cavity 2 and an outer cavity 7. The two inlet channels are implanted through the apex of the left ventricle 8. The inner cavity 2 is inserted into the apex of the infundibulum of the right ventricle 1 through the opening of the left ventricle corresponding to the interventricular septum. The outer cavity 7 is inserted into and remains in the left ventricle 8. The two outlet channels originate from the left and right ventricle assist devices and are respectively connected to the aorta 11 and the pulmonary artery 10. The two outlet channels are connected to the aorta 11 and the pulmonary artery 10 respectively through an artificial blood vessel via a circulation drive device.

[0036] In this embodiment, a first stoma 3 is formed on the outer wall of the left ventricle 8, and 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. 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 interventricular septum between the apex of the right ventricle 1 and the left ventricle 8. This apex interventricular septum is the interventricular septum between the funnel-shaped apex of the right ventricle 1 and the apex of the left ventricle 8.

[0037] In this embodiment, the inner cavity 2 is long and curved in an arc, while the outer cavity 7 is short and located entirely outside the inner cavity 2. One end of the inner cavity 2 is inserted into the infundibulum of the right ventricle 1 through the apex of the right ventricle via the interventricular septum, and the other end extends through the outer cavity 7 and connects to the circulation drive device.

[0038] 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 a first artificial blood vessel 12, and the second pump 6 is connected to the pulmonary artery 10 through a second artificial blood vessel 9. Both the first pump 5 and the second pump 6 are magnetically levitated pumps.

[0039] Features of this invention: 1. Biventricular assist, but with only one entrance at the apex of the left ventricle on the cardiac surface, requiring only one suture site during biventricular assist. 2. A ventricular septum stoma serves as the right ventricular entrance, located at the apex of the anatomical right ventricular outflow tract. 3. Direct visualization puncture of the ventricular septum allows for implantation of the right ventricular unloading port, eliminating the need for sutures (ventricular septum stomas require no sutures). 4. The right ventricular entrance is located in the right ventricular outflow tract, without interference from intracardiac structures. 5. The right ventricular entrance of the artificial heart is located at the apex of the infundibulum, maintaining the structural integrity of the functional right ventricle. 6. The infundibulum has a simple anatomical structure, avoiding interference from intraventricular structures. 7. The right ventricular unloading entrance is located inside the heart, minimizing the travel distance and reducing blood disruption and thrombus formation. 8. Direct unloading of the right ventricle is more convenient and facilitates drainage compared to right atrial unloading. 9. The inflow tracts of the left and right artificial ventricles are internally a double-chamber structure, with separate external ventricular centrifugal pumps for each, each with an independent control system. 10. The outflow tracts are anastomosed to the main pulmonary artery.

[0040] Example 2

[0041] The method of use for this invention is similar to current LVAD implantation procedures. The main pump is located outside the apex of the heart and above the diaphragm; the need for an artificial pocket depends on the size of the pump. The left ventriculostomy and suturing are exactly the same as for LVAD implantation. The left ventriculostomy is punctured to correspond to the interventricular septum in the infundibulum of the right ventricle, and an intraluminal channel is implanted into the right ventricular outflow tract without suturing or fixation. The outlets of the left and right ventricular auxiliary pumps are anastomosed to the ascending aorta and pulmonary artery trunks respectively via artificial blood vessels. The left and right artificial heart pumps are activated to complete biventricular assist. The left and right ventricular pumps operate independently and can adjust their respective parameters according to the function of the left and right ventricles to maintain systemic and pulmonary circulation.

[0042] The present invention discloses an implantation method for an integrated biventricular assist device, specifically comprising:

[0043] Step 1: After making a hole near the apex of the left ventricle 8 to form the first stoma 3, puncture the second stoma 4 in the apical interventricular septum of the right ventricle 1 through the infundibulum and implant the artificial heart into the right ventricular inlet (inner cavity 2) into the infundibulum of the right ventricle 1. No suture is required at the second stoma 4.

[0044] Step 2: After confirming the normal position of the left and right ventricular artificial heart inflow tracts, the external cavity 7 is sutured and fixed at the first stoma 3;

[0045] Step 3: The outflow pipes are anastomosed with the aorta 11 and the pulmonary artery 10 respectively. The first pump 5 and the second pump 6 of the circulation drive device are connected to the aorta 11 and the pulmonary artery 10 respectively through the first artificial blood vessel 12 and the second artificial blood vessel 9.

[0046] Step 4: Activate the left and right artificial heart pumps (first pump 5 and second pump 6) to complete biventricular assist;

[0047] Step 5: The left and right ventricular pumps (first pump 5 and second pump 6) work independently and can adjust their respective parameters according to the function of the left and right ventricles to maintain systemic circulation and pulmonary circulation.

[0048] Advantages of this product design: 1. This is the world's first applicable dual ventricular assist device (DVAD). 2. The assist device enters the heart through a conventional left ventricular inlet, with both artificial ventricles located inside the heart, simplifying implantation and avoiding the complications of long inlets leading to channel distortion, significant blood disruption, and increased risk of thrombosis. 3. It avoids incomplete right ventricular unloading due to poor drainage from the right atrium or right ventricle. 4. It causes no damage or disruption to the functional right ventricle. 5. The overall device is small and easy to implant. 6. The assist can be removed individually or entirely depending on the recovery status of the left and right ventricles, making it the world's only operable, high-efficiency, and removable DVAD.

[0049] Features of this invention: 1. Biventricular assist device (LVAD): The connection between the assist device and the heart surface is the same as current LVADs, i.e., dual inlets and single connection, achieving the smallest overall volume of the artificial biventricular ventricle. 2. The ventricular septum serves as the artificial right ventricular inlet. The inlet is located at the apex of the anatomical right ventricular infundibulum, ensuring no damage to the right ventricular free wall and facilitating the removal of LVAD. 3. The ventricular septum requires no sutures, simplifying the surgical procedure. 4. The artificial right ventricular inlet is located in the right ventricular outflow tract, free from interference from intracardiac structures; the opening direction is parallel to the right ventricular outflow tract, facilitating full unloading of the right ventricle. 5. The inflow tracts of the left and right artificial ventricles are internally a double-chamber structure, with the external portion divided into left and right ventricular pumps, each with independent flow control. 6. The outflow tracts are anastomosed to the main pulmonary artery.

[0050] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. A one-piece structure dual-ventricle independent auxiliary device, characterized in that, include: The two access routes and two exit routes are connected. The two access routes have a dual-chamber structure, including an inner cavity (2) and an outer cavity (7). The two access routes are implanted through the left ventricle (8). The inner cavity (2) is inserted into the right ventricle (1), and the outer cavity (7) is inserted into the left ventricle (8). The two exit routes are connected to the aorta (11) and the pulmonary artery (10) respectively through a circulation drive device.

2. The integrated dual-ventricle independent auxiliary device according to claim 1, characterized in that, The left ventricle (8) has a first stoma (3) on its outer wall, and the right ventricle (1) has a second stoma (4) on the interventricular septum between the left ventricle (8). The external cavity (7) is fixed at the first stoma (3) and inserted into the left ventricle (8) through the first stoma (3). The internal cavity (2) is inserted into the right ventricle (1) through the left ventricle (8) and the second stoma (4) in sequence.

3. The integrated dual-ventricle independent auxiliary 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 apical interventricular septum between the right ventricle (1) and the left ventricle (8). The apical interventricular septum is the interventricular septum between the funnel apex of the right ventricle (1) and the apex of the left ventricle (8).

4. The integrated dual-ventricle independent auxiliary device according to claim 1, characterized in that, The inner cavity (2) is long and curved in an arc, and the outer cavity (7) is short and located outside the inner cavity (2) for its entire circumference.

5. The integrated dual-ventricle independent auxiliary 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 apex of the funnel of the right ventricle (1) via the interventricular septum, and the other end passes through the outer cavity (7) and is connected to the circulation drive device.

6. The integrated dual-ventricle independent auxiliary device according to claim 1, characterized in that, The circulating drive device includes a first pump (5) and a second pump (6), the first pump (5) being connected to the outer cavity (7) and the second pump (6) being connected to the inner cavity (2).

7. The integrated dual-ventricle independent auxiliary device according to claim 6, characterized in that, 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).

8. The integrated dual-ventricle independent auxiliary device according to claim 6 or 7, characterized in that, Both the first pump (5) and the second pump (6) are magnetic levitation pumps.

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