CN110755708A

CN110755708A - Left ventricle auxiliary device outside heart chamber

Info

Publication number: CN110755708A
Application number: CN201911053394.6A
Authority: CN
Inventors: 刘弟世闻; 杨波
Original assignee: Wuhan University WHU
Current assignee: Wuhan University WHU
Priority date: 2019-10-31
Filing date: 2019-10-31
Publication date: 2020-02-07

Abstract

An extraventricular left ventricle auxiliary device relates to the field of medical equipment. The ventricular external left ventricle auxiliary device comprises a heart support, a heart extrusion film and an inflation and deflation device, wherein the heart support is used for being sleeved on the surface of a heart and is made of an elastic material; the heart extrusion film is arranged on the inner wall of the heart support and is provided with a plurality of shielding area non-extrusion parts covering a running area of a heart coronary artery and a plurality of expandable or contractible extrusion parts; the inflation and deflation device is used for driving the expansion or contraction of each extrusion part. The application provides an extraventricular left ventricle auxiliary device can implant the epicardium through minimal access surgery and play the effect of supplementary ventricle shrink to accessible intervene operation or thoracoscope and remove and do not destroy original anatomical structure, can avoid the complication that traditional left ventricle auxiliary device produced.

Description

Left ventricle auxiliary device outside heart chamber

Technical Field

The application relates to the field of medical equipment, in particular to an extraventricular left ventricle auxiliary device.

Background

Chronic Heart Failure (CHF) imposes a serious medical and economic burden on the world. Although advances in drug therapy and treatment of cardiac resynchronization can improve CHF symptoms and quality of life and reverse partial myocardial remodeling, many patients, even while receiving optimal drug therapy, eventually progress to drug-refractory end-stage CHF. The best treatment for end-stage CHF is heart transplantation, however, the shortage of donor organs requires alternative treatment strategies. Left Ventricular Assist Device (LVAD), which is a bridging or ultimate purpose therapy for transplantation, has become an increasingly accepted treatment strategy for these patients.

LVADs have experienced significant development and have become increasingly sophisticated over the past several decades. A large body of clinical data has shown that continuous axial flow LVADs, such as HeartMate ii, increase the survival rate and improve the quality of life of end-stage CHF patients. HeartMate III is a new continuous axial flow pump that minimizes shear stress to minimize adverse effects on blood constituents, and in addition, the inflow cannula is cannulated to the pump and can be inserted directly into the left ventricle, the pump body is located in the pericardium, and other such new designs and improvements allow for less invasive pump implantation procedures to the heart without the use of extracorporeal circulation support. It has a number of disadvantages, however, since it is in direct contact with blood and affects hemodynamic stability, the incidence associated with LVAD use, such as right ventricular failure, hemorrhage, intra-pump thrombosis, hemolysis, infection, aortic insufficiency and cerebral infarction, remains relatively high, and direct contact with the circulatory system and affecting hemodynamic stability can be a congenital defect in LVAD design and is unavoidable. Unlike drug eluting stents, LVAD is a large piece of artificial implantable device, and vascular endothelial cells cannot fully attach to the luminal growth to cover the entire LVAD lumen. Complications are serious and difficult to circumvent due to the disruption of vascular endothelial integrity, long-term anticoagulation or antiplatelet therapy, and depletion of visible components in the blood. The current technology does not appear to fully mimic the effects of vascular endothelial cell function. In addition, the continuous axial flow design is different from a pulse pump synchronized with the heart beat, which can provide a reserve of elastic potential energy for the aorta and the middle artery, and is beneficial to improving microcirculation. The continuous axial flow design pumps blood into the aorta throughout the cardiac cycle, which tends to cause aortic regurgitation and induce the onset of heart failure. In addition, the vascular anastomosis must be performed after cardiac arrest with the support of extracorporeal circulation, the surgical procedure causes damage to the heart itself, the implantation process is relatively complicated, and the equipment maintenance cost is expensive, which are disadvantages that the current LVAD cannot be widely used clinically.

Disclosure of Invention

An object of the application is to provide an extraventricular left ventricle auxiliary device, it can implant the epicardium through minimal access surgery and play the effect of supplementary ventricle shrink, and accessible intervene operation or thoracoscope and remove and do not destroy original anatomical structure to can avoid the complication that traditional left ventricle auxiliary device produced.

The embodiment of the application is realized as follows:

the embodiment of the present application provides an extraventricular left ventricle auxiliary device, it includes:

the heart stent is sleeved on the surface of the heart and is made of an elastic material;

the heart extrusion film is arranged on the inner wall of the heart support and is provided with a plurality of shielding area non-extrusion parts covering a running area of a coronary artery of the heart and a plurality of expandable or contractible extrusion parts;

and the inflation and deflation device is used for driving each extrusion part to expand or contract.

In some alternative embodiments, the cardiac stent is composed of a plurality of stent units in a zigzag shape.

In some alternative embodiments, a first confinement ring is sleeved on at least one stent unit.

In some alternative embodiments, at least one pair of adjacent stent units is sleeved with a second constraining ring.

In some alternative embodiments, the cardiac squeeze film is composed of two layers of elastic films with edges connected with each other, a plurality of areas connected with each other are arranged between the two layers of elastic films to form a plurality of shielding area non-squeezing parts, and squeezing cavities respectively positioned in the corresponding squeezing parts are formed by enclosing the two layers of elastic films.

In some alternative embodiments, adjacent extrusion chambers are in communication with each other.

In some optional embodiments, the inflation and deflation device comprises a cylinder body with an air chamber, a screw rod rotatably arranged in the air chamber, a piston sleeved on the screw rod through threads, and a motor for driving the screw rod to rotate, the air chamber is connected with a gas conveying pipeline, and the plurality of extrusion cavities are respectively communicated with the gas conveying pipeline.

In some alternative embodiments, the volume of the gas chamber is 30-60 mL.

The beneficial effect of this application is: the ventricular external left ventricle auxiliary device provided by the embodiment of the application comprises a heart support, a heart extrusion membrane and an inflation and deflation device, wherein the heart support is used for being sleeved on the surface of a heart and is made of an elastic material; the heart extrusion film is arranged on the inner wall of the heart support and is provided with a plurality of shielding area non-extrusion parts covering a running area of a heart coronary artery and a plurality of expandable or contractible extrusion parts; the inflation and deflation device is used for driving the expansion or contraction of each extrusion part. The application provides an extraventricular left ventricle auxiliary device can implant the epicardium through minimal access surgery and play the effect of supplementary ventricle shrink to accessible intervention operation or thoracoscope remove and do not destroy original anatomical structure, operation process and required equipment condition are simple relatively, and the postoperative does not need long-term anticoagulation and anti-platelet treatment simultaneously, also can not produce mechanical induced hemolysis, can to a great extent avoid the produced complication of traditional LVAD.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.

Fig. 1 is a schematic sectional structural view of an extra-ventricular left ventricular assist device provided in an embodiment of the present application;

fig. 2 is a schematic structural diagram of a heart support in an extraventricular left ventricular assist device according to an embodiment of the present application;

FIG. 3 is a schematic structural diagram of a cardiac squeeze membrane in an extraventricular left ventricular assist device according to an embodiment of the present disclosure;

FIG. 4 is a cross-sectional view taken along line A-A of FIG. 3;

fig. 5 is a schematic structural diagram of an inflation/deflation device in an extraventricular left ventricular assist device according to an embodiment of the present application.

In the figure: 100. a heart scaffold; 101. a holder unit; 102. a first confinement ring; 103. a second confinement ring; 200. a cardiac squeeze membrane; 201. an elastic film; 210. a shielding region non-extrusion portion; 220. a pressing section; 230. an extrusion chamber; 240. a central delivery conduit; 241. a branch pipe; 300. an air charging and discharging device; 310. a cylinder body; 311. an air chamber; 320. a screw rod; 330. a piston; 340. a motor; 350. a gas delivery conduit.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present application, presented in the accompanying drawings, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships that the products of the application usually place when in use, and are used only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the devices or elements being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present application. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal", "vertical", "overhang" and the like do not imply that the components are required to be absolutely horizontal or overhang, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present application, it is further noted that, unless expressly stated or limited otherwise, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

In this application, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may comprise direct contact of the first and second features, or may comprise contact of the first and second features not directly but through another feature in between. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

The features and performance of the extraventricular left ventricular assist device of the present application are described in further detail below in conjunction with the examples.

As shown in fig. 1, fig. 2, fig. 3, fig. 4 and fig. 5, an extraventricular left ventricular assist device according to an embodiment of the present application includes an annular cardiac stent 100, a cardiac squeeze film 200 and an inflation/deflation device 300; the heart stent 100 is formed by connecting 68 n-shaped stent units 101, each stent unit 101 is made of Nitinol (Nitinol) alloy material, each n-shaped stent unit 101 is sleeved with a first restraint ring 102, each n-shaped stent unit 101 is sleeved with two adjacent stent units 101 at two sides of the n-shaped stent unit 101 and connected with the two adjacent stent units 101 through two corresponding second restraint rings 103, and each first restraint ring 102 and each second restraint ring 103 are made of biocompatible material; the heart squeezing membrane 200 is composed of two layers of elastic membranes 201 with edges connected with each other, eighty eight regions connected with each other are arranged between the two layers of elastic membranes 201 to form eighty eight non-squeezing parts 210 used for covering a shielding region of a running region of a coronary artery of the heart, ninety six squeezing parts 220 are enclosed between the two layers of elastic membranes 201, each squeezing part 220 is internally provided with a squeezing cavity 230, the adjacent squeezing cavities 230 are communicated with each other, and the elastic membranes 201 are made of biocompatible materials; the inflation and deflation device 300 comprises a cylinder body 310 with an air chamber 311, a screw rod 320 rotatably arranged in the air chamber 311, a piston 330 sleeved on the screw rod 320 through threads, and a motor 340 for driving the screw rod 320 to rotate, wherein the motor 340 is connected with an ECG digital signal acquisition electrode wire, the air chamber 311 is connected with a gas conveying pipeline 350, the gas conveying pipeline 350 is communicated with a central conveying pipeline 240 extending between two layers of elastic membranes 201, and each extrusion cavity 230 is respectively communicated with the central conveying pipeline 240 through a branch pipe 241; the cylinder 310 has a diameter of 4.00cm, a height of 3.58cm, a piston speed of 0.12m/s, a volume of the air chamber 311 of 60mL, a sum of the volumes of the screw 320 and the piston 330 of 15mL, and the gas delivery tube 350 and the central delivery tube 240 are made of biocompatible materials.

The ventricular external left ventricle auxiliary device provided by the embodiment of the application can be implanted to the epicardium through a minimally invasive surgery without the need of thoracotomy and dissection of large blood vessels, so that huge wounds caused by the traditional LVAD implantation surgery are effectively reduced; when the extraventricular left ventricular assist device provided by the embodiment of the application is implanted, firstly, a series of parameters such as coronary artery area, running direction and heart size are determined through coronary angiography and coronary artery CTA in preoperative preparation, various indexes of a heart support 100 (the number and the size of support units 101), a heart compression membrane 200 (the number and the size of non-compression parts 210 and compression parts 220 of a shielding area) and an inflation and deflation device 300 (the volume of an air chamber 311 and the volume of a screw rod 320 and a piston 330) in the extraventricular left ventricular assist device are determined through the parameters, and then the left anterior minimally invasive thoracotomy is used for the implantation operation under general anesthesia; the patient takes a supine position, uses X-ray fluoroscopy to check and identify the apex of the heart, the position of a small incision is slightly lower than the apex of the heart so as to ensure that a guider is in a correct position, determines whether rib expanding operation is needed according to the size of the inflation and deflation device 300, opens the pericardium covering the apex of the heart and pulls the pericardium by using a suture, inserts the guider into the pericardium and expands the pericardium, uses a 10mm thoracoscope to check through the guider, ensures that a delivery system is not blocked to the apex of the heart, confirms whether the pericardium is adhered to prolong the operation process, advances the delivery system through the guider under the X-ray fluoroscopy guidance, confirms the position of the room interval and finds the junction of the left ventricle and the right ventricle, uses a sucker to suck the apex of the heart, uses the delivery system to push the heart support 100 and the heart extrusion film 200 arranged on the inner side of the heart support 100 to the correct position for wrapping the heart, and ensures that the thoracoscope outside of the heart auxiliary device is properly arranged on In place, the opened pericardium is left unsewn and the thoracic drain placed, and the incision is closed in a standard manner.

This extraventricular left ventricle auxiliary device implants to patient extracardiac back, through the reciprocal rotation of motor 340 drive lead screw 320 of gassing device 300, can drive piston 330 and remove along lead screw 320, thereby pass into central transfer line 240 between two-layer elastic membrane 201 or withdraw through gas transfer line 350 with the helium in the gas chamber 311, and then in passing into each extrusion chamber 230 with helium periodicity, thereby drive ninety six extrusion portions 220 on the extraventricular extrusion membrane 200 of the extracardiac heart and expand extrusion ventricle or shrink, realize the supplementary function that increases the ventricular ejection of blood fraction.

The heart stent 100 wrapped outside the heart squeeze film 200 is used for limiting expansion caused by power generated by inflation of the squeezing portion 220, and the first restraint ring 102 and the second restraint ring 103 are added on each bracket unit 101 in the shape of a Chinese character 'ji' of the heart stent 100, so that inward contraction of the stent is not influenced, outward expansion of the heart squeeze film 200 is limited, and the squeezing portion 220 provides fixed inward compression force.

The heart extrusion film 200 made of biocompatible material is fixed inside the heart stent 100, and has strong ductility and elasticity, and has a plurality of extrusion parts 220 with structures similar to cells and communicated with each other to provide corresponding pressure, so that the heart extrusion film can effectively assist in extruding the ventricles to improve blood supply function, and meanwhile, in order to not remarkably compress the coronary artery, the heart extrusion film 200 is provided with a non-extrusion part 210 of a shielding region which is not expanded and corresponds to the coronary artery for protection, so as to avoid damaging the coronary artery.

When the inflation and deflation device 300 works, the volume of gas in the extrusion cavity 230 conveyed to each extrusion part 220 is adjusted by the movement distance of the piston 330 driven by the motor 340, so that the pressure of the extrusion parts 220 extruding the heart is adjusted to increase the ejection fraction, and the ECG digital signal acquisition electrode wire is arranged in the heart support 100 to convert the collected ECG data into a signal for controlling the motor 340 and drive the motor 340 to contract synchronously with the heart.

The gas delivery device composed of the gas delivery pipe 350 and the central delivery pipe 240 is made of an elastic material with biocompatibility, helium gas delivery is not affected, gas delivery can be performed quickly and efficiently corresponding to movement of the piston 330, delivered helium gas is light in weight, good in inertia, strong in safety, and faster in delivery speed than air.

In some alternative embodiments, the volume of the air chamber 311 may also be 30-60mL, such as but not limited to 30mL, 35mL, 40mL, 45mL, 50mL, 55mL, or 60mL, and the frequency of piston reciprocation is 60-100 times/min, such as but not limited to 60 times/min, 70 times/min, 80 times/min, 90 times/min, or 100 times/min.

The embodiments described above are some, but not all embodiments of the present application. The detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

Claims

1. An extraventricular left ventricular assist device, comprising:

the heart squeezing film is arranged on the inner wall of the heart stent and is provided with a plurality of shielding area non-squeezing parts covering a running area of a heart coronary artery and a plurality of expandable or contractible squeezing parts;

2. An extraventricular left ventricular assist device according to claim 1, wherein the cardiac stent is composed of a plurality of stent units in a zigzag shape.

3. A ventricular assist device as claimed in claim 2, wherein the first restraining ring is sleeved on at least one of the stent units.

4. A ventricular assist device as claimed in claim 2, wherein at least one pair of adjacent stent units is sleeved with a second restraining ring.

5. A ventricular assist device as claimed in claim 1, wherein the cardiac squeeze membrane is composed of two layers of elastic membranes with edges connected to each other, the two layers of elastic membranes have a plurality of areas connected to each other to form a plurality of non-squeezing portions of the shielding area, and the two layers of elastic membranes are enclosed to form squeezing cavities respectively located in the corresponding squeezing portions.

6. An extraventricular left ventricular assist device as claimed in claim 5, wherein adjacent ones of the crush chambers are in communication with one another.

7. A ventricular assist device as claimed in claim 5, wherein the inflation/deflation device includes a cylinder having an air chamber, a screw rod rotatably disposed in the air chamber, a piston disposed on the screw rod through a thread, and a motor for driving the screw rod to rotate, the air chamber is connected with a gas delivery conduit, and the plurality of squeezing chambers are respectively communicated with the gas delivery conduit.

8. An extraventricular left ventricular assist device as claimed in claim 7, wherein the volume of the air chamber is 30-60 mL.