CN114010938A

CN114010938A - External pressing type heart auxiliary device for ventricles

Info

Publication number: CN114010938A
Application number: CN202010688962.6A
Authority: CN
Inventors: 胡盛寿; 柳光茂; 张云鹏
Original assignee: Fuwai Hospital of CAMS and PUMC
Current assignee: Fuwai Hospital of CAMS and PUMC
Priority date: 2020-07-16
Filing date: 2020-07-16
Publication date: 2022-02-08

Abstract

The invention discloses a ventricular external pressing type heart auxiliary device which comprises a flexible air bag, an air path conduit, a gas pressure pump and a pressure controller, wherein the flexible air bag comprises a plurality of air bags arranged along the circumferential direction and a telescopic metal bracket made of elastic memory alloy, the metal bracket is arranged at the outer edge of the plurality of air bags, the plurality of air bags are connected with the pressure controller and the gas pressure pump through the air path conduit, and the gas pressure supplied to the flexible air bags by the gas pressure pump is controlled through the pressure controller. The ventricular external pressing type heart assist device can assist the ventricles in the contraction and relaxation stages, can be implanted in a minimally invasive mode, and does not need to perform an open chest operation.

Description

External pressing type heart auxiliary device for ventricles

Technical Field

The invention relates to an external pressing type heart auxiliary device for ventricles, and belongs to the technical field of medical instruments.

Background

Heart failure is a serious stage of heart disease development, endangers patient life, and is a major public health problem in developed and developing countries. At present, the main treatment means of severe heart failure are drug therapy, heart transplantation, heart auxiliary devices and the like. The medicine has limited curative effect, is mostly used for relieving symptoms and cannot radically cure the diseases; heart transplantation is the most effective treatment for heart failure, but is limited by problems of donor shortages and matching. With the development of technology in recent years, heart assist devices have played an increasingly important role in the treatment of heart failure. The heart assist device is an artificial device for assisting the heart in pumping blood on the premise of keeping the heart of a patient. Heart assist devices were first developed in the last 60 s, and have been an important treatment for heart failure over several decades.

The current heart assist devices are mainly classified into blood contact type and non-blood contact type. Blood-contact heart assist devices reduce the load on the patient's heart, often by drawing blood from the left ventricle and then through the assist device, passing the blood to the aorta. The blood contact type auxiliary device can adopt various pulsating pumps, axial flow pumps, centrifugal pumps and the like, because parts in the device are contacted with blood for a long time, thrombus is easy to appear, and simultaneously, a patient is required to take anticoagulant drugs for a long time. In addition, the high speed of the impeller tip is easy to destroy blood cells in blood, thereby causing hemolysis. The above problems with blood contact heart assist devices limit their clinical application.

Non-contact heart assist devices were first proposed in 1956 by Bencini et al, primarily to mechanically press the heart to assist the heart in pumping blood. At present, a non-contact heart assist device is provided with a pneumatic type and an electric type, and the pneumatic energy and the electric energy are respectively utilized to drive the heart assist device to contract so as to realize the purpose of pressing the heart.

The existing pressing type ventricular assist device mainly has the following problems:

1. heart failure, has two main forms: systolic insufficiency and diastolic insufficiency. The conventional ventricular assist device mainly solves systolic insufficiency, i.e., performs assisted compression mainly in the systolic phase of the ventricle, but cannot assist diastole in the diastolic phase.

2. None of the conventional devices are implanted in a minimally invasive manner, open chest surgery is required, and most conventional devices require suturing the device to the heart or pericardium.

Disclosure of Invention

The invention aims to provide an external pressing type heart auxiliary device for ventricles, which can assist the ventricles in the contraction and relaxation stages and can be implanted in a minimally invasive mode without performing an open chest operation.

In order to achieve the purpose, the invention adopts the following technical scheme:

the utility model provides a ventricular external pressing formula heart auxiliary device, comprises flexible gasbag, gas circuit pipe, gas force pump and pressure controller, and wherein flexible gasbag includes a plurality of gasbags and the scalable metal support of being made by elasticity memory alloy that arrange along the circumferencial direction, and the metal support setting is along the outer of a plurality of gasbags, and a plurality of gasbags pass through the gas circuit pipe to be connected with pressure controller and gas force pump, controls the gas force that gas force pump supplied to flexible gasbag through pressure controller.

Preferably, each of the flexible bladders is controlled individually; or a plurality of air bags are communicated to form a parallel structure to be controlled together. By controlling one or more of the flexible bladders separately, different portions can be pressed separately as desired.

Preferably, the plurality of balloons are connected to the pressure controller and the gas pressure pump via a multi-path gas path conduit.

Preferably, after the telescopic metal support is contracted, the whole flexible air bag is cylindrical.

Preferably, the number of the plurality of air bags is 6-12.

Preferably, the pressure controller comprises a pressure sensor and a control device, wherein the pressure sensor is respectively arranged on the flexible air bag and at a plurality of positions in the air path, so that the pressure change of the heart of the patient and the air pressure change in the air path are reflected in real time; the gas pressure within the flexible bladder is automatically controlled by the control device using patient history data and an intelligent algorithm.

The invention has the beneficial effects that:

(1) the heart assist device of the present invention does not directly contact blood, greatly reducing the risk of thrombosis.

(2) The heart assist device of the present invention can be implanted through a small incision, avoiding open chest surgery.

(3) The heart assist device can assist the compression and the relaxation at the same time, and improves the ventricular blood pumping efficiency.

(4) The invention can be adjusted according to different requirements of patients and doctors, and can control the frequency, pressure and amplitude of pressing, thereby controlling the contraction and relaxation of ventricles and adjusting the volume of pumped blood and blood pressure.

(5) The external gas pressure pump, the pressure controller and the power supply are portable, can be carried by a patient, and do not hinder normal life.

Drawings

FIG. 1 is a top view of a flexible bladder in a heart assist device of the present invention.

Fig. 2 is a cross-sectional view of a flexible bladder in the heart assist device of the present invention.

Fig. 3 is a schematic structural diagram of the heart assist device of the present invention.

Detailed Description

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

As shown in fig. 1 to 3, the ventricular external pressing type heart assist device of the present invention comprises a flexible air bag, an air path conduit, an air pressure pump and a pressure controller, wherein the flexible air bag comprises a plurality of air bags 1 arranged along a circumferential direction and a telescopic metal bracket 2 made of an elastic memory alloy, and the metal bracket 2 is arranged at the outer edge of the plurality of air bags 1 to form a metal mesh structure. The air bags are connected with a pressure controller and a gas pressure pump through one path or multiple paths of air path guide pipes, and the gas pressure supplied to the flexible air bags by the gas pressure pump is controlled through the pressure controller.

In the ventricular external pressing type heart auxiliary device, the pressure controller comprises a pressure sensor and a control device, wherein the pressure sensors are respectively arranged on the flexible air bag and at a plurality of positions in the air path, so that the pressure change of the heart of a patient and the air pressure change in the air path are reflected in real time; the gas pressure within the flexible bladder is automatically controlled by the control device using patient history data and an intelligent algorithm. By adopting the ventricular external pressing type heart auxiliary device, the pressing frequency, pressure and amplitude are adjusted and controlled according to different patient requirements and doctor requirements, so that the contraction and relaxation of the ventricles are controlled, and the blood pumping volume and the blood pressure are adjusted.

When the ventricular external pressing type heart assist device is used, the assist device is contracted in a cylindrical structure at the beginning, similar to a folded umbrella, and an air bag is not inflated at the moment and is relatively soft and foldable. The pericardium of the apex of the heart is cut, the device is stretched into the space between the heart and the pericardium, the metal structure is gradually opened by inflation to wrap the heart, the air bag is gradually unfolded, then the air bag is continuously inflated, the heart can be squeezed, and the flexible air bag is located between the heart and the pericardium and has a certain volume, so that the air bag can be relatively fixed.

In the ventricular external pressing type heart assist device of the invention, a plurality of air bags in the flexible air bags are supported by the metal bracket. The metal bracket is made of elastic memory alloy, so that the metal bracket can be contracted and expanded, the whole volume of the flexible air bag becomes very small after the metal bracket is contracted, the metal bracket can be contracted into a cylinder shape, the metal bracket is conveniently implanted into a patient body through a small incision, and the thoracotomy operation is avoided; after being unfolded, the air bag can be designed according to the shapes of the air bags to form a specific shape to wrap the heart of a patient, and pressure and deformation can be generated at different positions according to requirements by changing the gas pressure in the air bags. Also, metal stents can limit ventricular hyperrelaxation. At end systole and early diastole, the flexible balloon acts like a loaded spring, applying negative pressure to the epicardial surface to assist with ventricular filling. The pressing type heart auxiliary device can assist pressing and relaxation at the same time, and improves the ventricular blood pumping efficiency.

In the ventricular external pressing type heart auxiliary device, each air bag in the flexible air bags can be controlled independently, or a plurality of air bags in the flexible air bags can be communicated to form a parallel structure to be controlled together. By controlling one or more of the flexible bladders separately, different portions can be pressed separately as desired.

In the ventricular external pressing type heart auxiliary device, the number of the air bags in the flexible air bag can be selected at will according to actual needs, and preferably 6-12 air bags are used. Taking the example of adopting a 10-air-bag structure, wherein 4 air bags are arranged in the right ventricle, 6 air bags are arranged in the left ventricle, and the folds arranged in each air bag and the difference between the inner membrane and the outer membrane cause different expansion sizes, so that the auxiliary device can extrude the left ventricle more strongly, because the left ventricle participates in the systemic circulation, stronger pumping force is needed, and most of the problems of the contraction of the heart are the problems of the left ventricle.

In the ventricular external pressing type heart auxiliary device, the flexible air bag can acquire images by means of CT and the like according to the heart size and pathological change conditions of a patient, and then is independently designed according to the condition of each patient to realize close fit between the flexible air bag and the heart of the patient.

In the manufacturing process of the ventricular external pressing type heart assist device, the size of a metal support structure and the sizes of inner and outer membranes of a plurality of air bags are determined according to the actual size of the heart of a patient, an elastic memory alloy metal wire is used for manufacturing the metal support structure into a corresponding shape, then the metal support structure is connected with a bottom metal ring to form the metal support structure, the air bags are processed by integral forming, and then the manufactured metal support structure is connected and sealed with the air bags to form the pressing type heart assist device.

The elastic memory alloy material used in the present invention includes, but is not limited to, Ti-Ni alloy, Ti-Ni-Pd alloy, Ti-Nb alloy, etc. The balloon is made of biocompatible polymer materials, and is mostly made of polyurethane materials, including but not limited to polyvinyl chloride (PVC), Polyethylene (PE), polypropylene (PP), and Polystyrene (PS).

In the ventricular external pressing type heart auxiliary device, the external air pressure pump, the pressure controller, the power supply and the like are all portable and can be carried by a patient without interfering with normal life.

Claims

1. The utility model provides a ventricular external pressing formula heart auxiliary device which characterized in that comprises flexible gasbag, gas circuit pipe, gas force pump and pressure controller, and wherein flexible gasbag includes a plurality of gasbags and the scalable metal support of being made by elasticity memory alloy that arrange along the circumferencial direction, and the metal support sets up the outer edge at a plurality of gasbags, and a plurality of gasbags pass through the gas circuit pipe and are connected with pressure controller and gas force pump, control the gas force that gas force pump supplied to flexible gasbag through pressure controller.

2. A ventricular push-out heart assist device as claimed in claim 1, wherein each of the flexible bladders is individually controlled; or a plurality of air bags are communicated to form a parallel structure to be controlled together.

3. A ventricular push-out heart assist device as claimed in claim 1 or 2, wherein the plurality of balloons are connected to the pressure controller and the gas pressure pump via a multi-path airway tube.

4. A ventricular push-out heart assist device as claimed in claim 1 or 2, wherein the flexible bladder is generally cylindrical after the retractable metal stent is retracted.

5. A ventricular push-out type heart assist device as claimed in claim 1 or 2, wherein the number of the air bags is 6-12.

6. A ventricular push-out type heart assist device as claimed in claim 1 or 2, wherein the pressure controller comprises a pressure sensor and a control device, wherein the pressure sensor is respectively arranged on the flexible air bag and at multiple positions in the air passage to reflect the pressure change of the heart of the patient and the air pressure change in the air passage in real time; the gas pressure within the flexible bladder is automatically controlled by the control device using patient history data and an intelligent algorithm.