CN217506760U - Interventional operation in-vitro simulation system based on animal in-vitro heart - Google Patents

Abstract

The application discloses an interventional operation in-vitro simulation system based on an animal in-vitro heart, which comprises a box body with a containing area for installing an in-vitro test device, wherein a plurality of interfaces are installed on the box wall of the box body; one end of the connecting hose is communicated with the corresponding interface, the other end of the connecting hose is provided with an adapter, the pressure regulating system comprises a pulse pump and a buffer chamber, the sensor system is used for collecting and outputting relevant information, and the internal monitoring system is used for collecting and outputting the relevant information. The technical scheme of the application has the characteristics of short operation period, low operation cost, good observation effect and the like, plays an important role in the design, optimization and shaping processes of the artificial valve implant instrument, and can reflect the expected clinical use condition of the product through the hemodynamic performance. Meanwhile, for doctors who urgently need surgical skill training, the model can effectively improve training efficiency.

Description

Interventional operation in-vitro simulation system based on animal in-vitro heart

Technical Field

The application relates to the field of medical equipment, in particular to an interventional operation in-vitro simulation system based on an animal isolated heart.

Background

Interventional procedures are now well accepted as a solution to minimally invasive heart disease. Taking transcatheter interventional cardiac mitral valve implant replacement procedures as an example, the solution may load a prosthetic valve, such as a prosthetic mitral valve, onto a catheter, which is then percutaneously delivered to the heart where the diseased native mitral valve is located and releases the prosthetic mitral valve to replace the original diseased mitral valve. In the related art, after a prosthetic valve is developed, a series of tests, including animal tests, are performed on the prosthetic valve.

With the development of technology, in addition to testing animals directly, other methods can also be used for testing. For example, most test platforms on the market use artificial materials (silica gel or 3D printing) to make a model conforming to the structure of a simulated human heart, and then use the model for testing. However, there are the following technical problems:

(1) the manufacturing difficulty is high, and the cost is high;

(2) the artificial material is different from a real human heart, and especially, a native valve in a heart structure cannot be simulated, so that the accuracy and the reliability of the test are influenced. In the implantation and use effects of the catheter intervention mitral valve instrument, the native valve leaflets have important effects on the delivery, release, anchoring and hemodynamic performance of the implanted valve leaflets;

(3) the geometric structure and material property of the artificial model have great difference with the real heart structure, so that the main indexes of the release, transportation and other key tests, such as the elasticity, the friction force and the like of the central wall, have great deviation with the real conditions, and the in vitro test effect is poor. Due to the absence of the native valve leaflets in the heart structure, critical hydrodynamic properties such as unidirectional flow, pressure differential, etc. under physiological conditions are difficult to achieve in artificial heart chambers. In the implantation and use effects of the transcatheter intervention mitral valve instrument, the native valve leaflets have important effects on the delivery, release, anchoring and hemodynamic performance of the implanted valve leaflets, and the accuracy of the test can be affected.

Those skilled in the art have also attempted to cut out, place and fix the native valve annulus and leaflet tissue in animal hearts in artificial heart models. The scheme can simulate the structure of the real valve ring and the valve leaflets to a certain extent, but the operation is complex and difficult to control quantitatively, and meanwhile, the valve ring, the valve leaflets, the chordae tendineae, the papillary muscles, the ventricular wall and other structures in the heart of the animal are often mutually connected and cooperate, so that the real implantation effect cannot be well achieved.

Based on the problems, the conventional simulation device has a single simulation function, a small adjustable range and limited use effect in scenes such as training, simulation, in-vitro simulation and the like.

SUMMERY OF THE UTILITY MODEL

In order to solve the above technical problem, the present application discloses an interventional operation in vitro simulation system based on an animal isolated heart, comprising:

the in-vitro testing device comprises a box body, a testing device and a control device, wherein an accommodating area for installing an in-vitro testing device is arranged in the box body, and a plurality of interfaces are arranged on the box wall of the box body;

one end of the connecting hose is communicated to the corresponding interface, and the other end of the connecting hose is provided with an adapter for communicating the in-vitro testing device;

the pressure regulating system comprises a pulse pump and a buffer chamber, and the pulse pump and the buffer chamber are respectively communicated to corresponding interfaces;

the sensor system comprises a temperature sensor and/or a pressure sensor and is used for acquiring and outputting relevant information;

and the internal monitoring system comprises an endoscope and/or an ultrasonic probe and is used for acquiring relevant information and outputting the information.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative may be combined individually for the above general solution or between several alternatives without technical or logical contradictions.

Optionally, the interventional operation in-vitro simulation system further comprises:

the in-vitro testing device comprises an animal in-vitro heart and is positioned in the accommodating area;

and the conveyor system is butted to one interface and is used for conveying an interventional instrument to perform simulated interventional operation on the isolated heart of the animal.

Optionally, a heating device for adjusting the temperature is arranged in the box body, and the temperature sensor acquires a temperature signal in the box body and feeds the temperature signal back to the heating device correspondingly.

Optionally, the buffer chamber includes a gas container and a liquid container, the gas container and the liquid container are communicated with each other, and the gas container and the liquid container are communicated to different areas in the isolated heart of the animal through different interfaces respectively.

Optionally, for the same atrioventricular valve, the air volume is communicated to the downstream side of the atrioventricular valve, and the liquid volume is communicated to the upstream side of the atrioventricular valve;

the animal isolated heart, the gas container and the liquid container form a circulation loop, and the pulse pump is connected to the circulation loop.

Optionally, the interface includes:

a first interface for sharing the pulse pump and the conveyor system;

a second interface docked to an aortic outlet within the isolated heart of the animal, the gas volume being communicated to the second interface;

and the third interface is butted to the left atrium of the isolated heart of the animal, and the liquid volume is communicated to the third interface.

Optionally, the first port communicates via an apical site to a left ventricle of the isolated heart of the animal.

Optionally, the endoscope is accessed via the second interface; the first interface, the second interface and the third interface are all provided with the pressure sensors.

Optionally, a Y-adapter is arranged on the first interface, the Y-adapter is located in two branches outside the tank body, one branch is communicated with the pulse pump, and a sealing valve is installed on the other branch.

Optionally, the system further comprises a computer control system, and the pressure regulating system pulse pump, the sensor system and the internal monitoring system are in communication connection with the computer control system.

Optionally, the specific connection mode of each interface and the isolated heart of the animal is as follows:

the heart in vitro of the animal is provided with an opening with a preset size, each interface is inserted into the opening, and the opening and each interface are restrained by a restraining piece.

Optionally, the second interface is disposed on an aortic blood vessel of the isolated heart of the animal, and the third interface is disposed at a left atrium of the isolated heart of the animal.

The application also discloses intervention apparatus detecting system based on animal separation heart, including the external analog system of intervention operation and the detection module based on animal separation heart among the above-mentioned technical scheme, intervention apparatus is in place the back in the animal separation heart, detection module basis sensor system and/or the information evaluation detection performance that inside monitoring system gathered.

In the application, the isolated heart model refers to the condition that the heart of an animal is stripped, connected through a pipeline and filled with liquid so as to form the heart with the similar beating effect as the heart in vivo. Compared with animal tests before clinic, the model has the characteristics of short operation period, low operation cost, good observation effect and the like, plays an important role in the mechanical design, optimization and shaping processes of the artificial valve implant, and can reflect the expected clinical use condition of the product through the hemodynamic performance. Meanwhile, for doctors who urgently need surgical skill training, the model can effectively improve training efficiency.

Specific advantageous technical effects will be further explained in conjunction with specific structures or steps in the detailed description.

Drawings

FIG. 1 is a block diagram of an extracorporeal simulation system of an interventional operation based on an isolated heart of an animal in one embodiment;

FIG. 2 is a schematic diagram of an in vitro simulation system of an interventional operation based on an isolated heart of an animal in one embodiment;

FIG. 3 is a schematic view of an isolated cardiac vessel sealing connection of an animal in one embodiment;

fig. 4 is a schematic diagram of a sealing structure of a box interface in an embodiment.

The reference numerals in the figures are illustrated as follows:

1. a pulse pump; 2. a pressure sensor; 3. a heating rod; 4. a temperature sensor; 5. a computer control system; 6. a pressure sensor; 7. gas capacity; 8. liquid capacity; 9. a Y-shaped joint; 10. an endoscope; 11. a box body; 12. a pig heart; 13. an ultrasonic probe; 14. an ultrasonic display; 15. a conveyor system; 16. a sealing valve; 17. isolated cardiac blood vessels of animals; 18. a tapered adapter; 19. a connecting hose; 20. an endoscope cable; 21. an assembly hole; 22. a sealing seat; 23. a first seal member; 24. an adjustment member; 25. a second seal.

Detailed Description

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 only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

With reference to the accompanying figures 1 to 4, the present application discloses an interventional surgery in vitro simulation system based on an animal isolated heart, comprising:

the in-vitro testing device comprises a box body, a testing device and a control device, wherein an accommodating area for installing an in-vitro testing device is arranged in the box body, and a plurality of interfaces are arranged on the box wall of the box body;

one end of the connecting hose is communicated to the corresponding interface, and the other end of the connecting hose is provided with an adapter for communicating the in-vitro testing device;

the pressure regulating system comprises a pulse pump and a buffer chamber, and the pulse pump and the buffer chamber are respectively communicated to corresponding interfaces;

the sensor system comprises a temperature sensor and/or a pressure sensor and is used for acquiring and outputting relevant information;

and the internal monitoring system comprises an endoscope and/or an ultrasonic probe and is used for acquiring relevant information and outputting the information.

In a particular use, the interventional procedure in-vitro simulation system further comprises:

the in-vitro testing device comprises an animal in-vitro heart and is positioned in the accommodating area;

and the conveyor system is butted to one interface and is used for conveying an interventional instrument to perform simulated interventional operation on the isolated heart of the animal.

Above-mentioned technical scheme can practice thrift animal resources, solves the influence problem of native valve leaflet's lack to the separation testing arrangement haemodynamics. In a specific implementation mode, the animal heart is firstly stripped and completely stored, the animal heart generates a pulsation effect under the water pressure condition by connecting a pressure regulating system, and the interventional operation in-vitro simulation system based on the animal isolated heart better conforms to the actual physiological condition on the fluid mechanics principle. Meanwhile, the real valve ring and valve leaflet structure can be provided based on the arrangement of the animal isolated heart, the implantation process and the release effect of the interventional instrument can be simulated, and particularly the connection cooperation of the valve ring, the valve leaflets, the chordae tendinae, the papillary muscles, the ventricular wall and other structures.

The isolated heart of the animal above may be the whole heart or a part thereof.

In the composition of the interventional operation in-vitro simulation system, as shown in fig. 1, the interventional operation in-vitro simulation system may further include a computer control system, a pressure regulation system, a sensor system and an internal monitoring system, which are in direct or indirect communication connection with the computer control system according to the control and signal acquisition requirements. The animal ex vivo heart is hereinafter described by way of example as a porcine heart 12. The intervention site is a mitral valve as an example, and the intervention operation in-vitro simulation system in the embodiment aims to build an animal in-vitro heart test model of a mitral valve instrument so as to test the release process, anchoring effect, valve leaflet opening and closing conditions and the like of the mitral valve (left heart) in the animal heart. In order to adjust the temperature, referring to fig. 2, a heating device for adjusting the temperature is disposed in the box 11, and the temperature sensor collects the temperature signal in the box 11 and feeds the temperature signal back to the heating device accordingly. The heating means is embodied as a heating rod 3 in fig. 2. The temperature sensor 4 and the heating rod 3 are arranged on the inner wall of the box body 11 and used for controlling the water temperature to be within the range of 37 +/-2 ℃, and the computer control system 5 is used for inputting parameters.

The buffer chamber comprises a gas container 7 and a liquid container 8, the gas container 7 and the liquid container 8 are respectively communicated to different areas in the isolated heart of the animal through different interfaces, the liquid container 8 is used for storing liquid, the gas container 7 is used for buffering the liquid, a pulse cycle is formed under the uninterrupted operation of the pulse pump 1, and the pressure not less than 120mmHg can be formed, so that the aortic valve and the mitral valve are opened and closed regularly. Wherein, aiming at the same atrioventricular valve, the air volume 7 is communicated to the downstream side of the atrioventricular valve, and the liquid volume 8 is communicated to the upstream side of the atrioventricular valve; the heart of the animal in vitro, the air container 7 and the liquid container 8 form a circulation loop, and the pulse pump 1 is connected into the circulation loop.

In the connection relation, the interface includes:

a first interface, which is common to the pulse pump 1 and the conveyor system 15;

the second interface is butted to an aorta outlet of an isolated heart of an animal, and the air volume 7 is communicated to the second interface;

and the third interface is butted with the left atrium of the isolated heart of the animal, and the liquid container 8 is communicated with the third interface.

On the entry path, the endoscope 10 enters via the second interface; the first, second and third interfaces are each provided with a pressure sensor, for example pressure sensor 2 and pressure sensor 6 monitoring the pressure on the ventricular side and on the atrial side, respectively.

Wherein, the first interface is provided with a Y-shaped adapter, the Y-shaped adapter is positioned in two branches outside the box body, one branch is communicated with the pulse pump 1, and the other branch is provided with a sealing valve 16 (which can adopt a hemostatic valve in the existing interventional operation) for respectively communicating with the conveyor system 15 to penetrate. The conveyor system 15 includes a handle and a tube assembly connected to the handle and into which the interventional instrument is loaded, the tube assembly being movable through a passage in the sealing valve 16 and being leak proof.

The internal monitoring system may include an endoscope 10 and an ultrasonic probe, observe internal conditions such as an interventional instrument release process, an anchoring effect, and a leaflet opening and closing condition in real time through the endoscope 10 and the ultrasonic probe 13 (with an ultrasonic display 14 connected thereto), and output desired pictures and videos. Wherein the third interface can adopt a Y-shaped connector 9, which is convenient for extending into a probe cable of the endoscope 10.

In the sealing arrangement for each cable entering the box 11, as shown in fig. 4, the box 11 is provided with a sealing seat 22 on the corresponding interface, a cable channel penetrating through the sealing seat 22 is provided inside the sealing seat 22 to form the interface, wherein the sealing seat 22 is further provided with a first sealing element 23 for sealing the instrument channel, and the first sealing element 23 can switch its working state to open or close the cable channel to allow each cable to pass through. The seal holder 22 is provided with an adjusting member 24 for controlling different states of the first seal member 23. In the embodiment shown in the drawings, the first sealing member 23 is a plug seal and the adjustment member 24 is a sealing plug which is threadedly engaged with the instrument channel, and when the adjustment member 24 is moved to change its relative position with respect to the sealing seat 22, the form and position of the plug seal can be changed to seal or unseal the cable channel. In a specific dimension, the inner diameter of the plug seal ring may be set slightly smaller than the outer diameter of the cable. Meanwhile, the plug sealing rings can be arranged into a plurality of layers or a plurality of layers, and can be rubber rings, air bags and other forms in specific forms.

On the installation of seal receptacle 22, be equipped with the pilot hole that is used for being connected with box 11 on the seal receptacle 22 and be equipped with towards one side of box with box 11 seal complex second sealing member 25, second sealing member 25 can make the sealing washer around above-mentioned cable passageway on specifically setting up to realize sealed effect. In the figures, the cable is embodied as an endoscope cable 20, but in actual use and during set-up, it may be any other cable or tube that meets the requirements of the size.

In the working process, medical personnel can release the sealing pressure of the first sealing element 23 by unscrewing the adjusting element 24 (namely, the sealing plug), and after the endoscope cable 20 is adjusted to a proper position, the sealing plug is screwed until the first sealing element 23 is extruded and deformed, so that the endoscope cable 20 and the box body 11 are sealed and fixed so as to separate the heart of the animal.

On the opening of the interfaces, the specific connection mode of each interface and the isolated heart of the animal is as follows:

an opening with a preset size is formed in the heart of the animal in vitro, each interface is inserted into the opening, and the opening and each interface are restrained by a restraining piece. The restraint member may be in the form of an annular band or the like.

In addition to the arrangement of the binding member, referring to fig. 3, the modules of the interventional operation in-vitro simulation system based on the isolated heart of the animal are communicated with each other through a connecting hose 19, and the pipe diameter of the connecting hose 19 is preferably 25mm in specific dimensions. Be connected through tapered adapter 18 between connecting hose 19 and the animal separation heart blood vessel 17, tapered adapter 18 can adapt to the animal separation heart blood vessel 17 of different sizes through the conical surface of self, and is concrete, and tapered adapter 18's adaptation scope is 24 mm-30 mm, and the advantage of this setting lies in being convenient for change the animal separation heart of different dimensions in order to satisfy the building of different simulation conditions.

The specific assembly process is as follows:

fully cleaning the interior of the pig heart, removing thrombus and other foreign matters, and checking the integrity of the interior and exterior of the pig heart; a notch suitable for matching a small port with the diameter of 25-20 diameter-variable straight-through holes is cut at the apex of the heart by using a scalpel; cutting off the redundant part of the aortic vessel, inserting a small port with the diameter of 25-20 and straight through, and fastening by a binding belt; the left atrium 0.5cm above the auricle is excised, inserted into the small port with diameter varying diameter of 25-20 and tied with tie.

The pig heart is respectively connected with the pulse pump 1, the liquid container 8 and the gas container 7 through the first interface, the second interface and the third interface; filling liquid (clear water or normal saline) from the liquid container 8, removing gas in the system, and checking whether leakage exists; the computer control system and the pulse pump 1 are connected, the pulse pump 1 is started to operate in a small amplitude, and the pressure is gradually adjusted to meet the requirement.

The operation process of the interventional operation in-vitro simulation system is as follows:

proper amount of normal saline is added into the system through the liquid volume 8, the pulse pump 1 extrudes the liquid into the left ventricle of the pig heart 12 through compression, the mitral valve is closed reversely under the action of water pressure, the aortic valve is opened positively, and the liquid flows into the air volume 7 through the aortic valve.

Under the action of the pulse pump 1, when the aortic valve is closed reversely, liquid enters the left atrium through the air container 7 and the liquid container 8 in sequence and then flows into the left ventricle through the mitral valve.

An operator utilizes the conveyor system 15 to simulate the interventional operation, and a computer control system is utilized to comprehensively control the heating device, the sensor system and the pressure regulating system in the whole process, such as automatically regulating and controlling water temperature, outputting a test differential pressure curve, regulating pulse parameters of the pulse pump 1 (optionally a plunger pump) and the like. The internal monitoring system may operate independently or may be integrated or coordinated with the computer control system.

The present application mainly solves the following problems:

1. the problem of current separation test chamber geometry simulation degree low is solved. The animal isolated heart is used as a test cavity and completely comprises physiological structures such as native valve rings, valve leaflets, chordae tendineae, papillary muscles and the like, so that the valve implantation in-vitro test which can only play a role by means of the native valve becomes possible, and the geometric test conditions of the device in the processes of conveying, releasing, anchoring and the like are optimized.

2. The problem of current separation test cavity material attribute simulation degree low is solved. The animal isolated heart optimizes the material property conditions in the processes of conveying, releasing and anchoring test, and optimizes the conditions of central wall constraint, supporting force, compliance and the like in the process of testing the performance of the valve implant.

3. The problem of current separation test chamber hydrodynamics characteristic simulation degree low is solved. Under the conditions that the native valves exist and the volume of the heart cavity and the elastic characteristic are highly simulated, the simulation system can better simulate the conditions of blood flow direction, cross-valve pressure difference and the like in a real body environment.

To sum up, the simulation system in this application produces the heart beat and the blood flow dynamics characteristic that are close to the in vivo state when realizing higher geometry and material fidelity, can the experimental test effect of animal before the effectual simulation clinic, has practiced thrift animal resources and operation cost, and not so only intervene the instrument and place in animal separation heart, can also real-timely carry out performance test and aassessment.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. Features of different embodiments are shown in the same drawing, which is to be understood as also disclosing combinations of the various embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims (10)

1. An interventional operation in-vitro simulation system based on an animal isolated heart is characterized by comprising:

the in-vitro testing device comprises a box body, a testing device and a control device, wherein an accommodating area for installing an in-vitro testing device is arranged in the box body, and a plurality of interfaces are arranged on the box wall of the box body;

one end of the connecting hose is communicated to the corresponding interface, and the other end of the connecting hose is provided with an adapter for communicating the in-vitro testing device;

the pressure regulating system comprises a pulse pump and a buffer chamber, and the pulse pump and the buffer chamber are respectively communicated to corresponding interfaces;

the sensor system comprises a temperature sensor and/or a pressure sensor and is used for acquiring and outputting relevant information;

and the internal monitoring system comprises an endoscope and/or an ultrasonic probe and is used for acquiring relevant information and outputting the information.

2. The animal ex vivo heart-based interventional procedure in-vitro simulation system of claim 1, further comprising:

the in vitro testing device comprises an animal in vitro heart and is positioned in the accommodating area.

3. The system of claim 2, wherein a heating device for adjusting the temperature is provided in the box, and the temperature sensor collects the temperature signal in the box and feeds the temperature signal back to the heating device accordingly.

4. The animal ex vivo heart-based interventional surgery in vitro simulation system of claim 2,

the buffer chamber comprises an air volume and a liquid volume, the air volume and the liquid volume are communicated with each other and are respectively communicated to different areas in the isolated heart of the animal through different interfaces;

the animal in-vitro heart comprises at least one atrioventricular valve, and aiming at the same atrioventricular valve, the air volume is communicated to the downstream side of the atrioventricular valve, and the liquid volume is communicated to the upstream side of the atrioventricular valve;

the animal isolated heart, the air container and the liquid container form a circulation loop, and the pulse pump is connected to the circulation loop.

5. The animal ex vivo heart-based interventional surgery in vitro simulation system of claim 4,

the interface includes:

a first interface for use by the pulse pump and a conveyor system for conveying the interventional instrument;

a second interface, wherein the second interface is connected to an aorta outlet of the isolated heart of the animal, and the air capacitor is communicated to the second interface;

and the third interface is butted to the left atrium of the isolated heart of the animal, and the liquid volume is communicated to the third interface.

6. The ex-vivo animal heart-based interventional surgery simulation system of claim 5, wherein the first interface communicates via an apical site to a left ventricle of the ex-vivo animal heart.

7. The animal ex vivo heart-based interventional procedure in-vitro simulation system of claim 5, wherein the endoscope is accessed via the second interface; the first interface, the second interface and the third interface are all provided with pressure sensors.

8. The animal ex vivo heart-based interventional operation in vitro simulation system according to claim 5, wherein a Y-adapter is arranged on the first interface, the Y-adapter is positioned in two branches outside the box body, one branch is communicated with the pulse pump, and the other branch is provided with a sealing valve.

9. The ex-vivo animal heart-based interventional surgery simulation system of claim 1, further comprising a computer control system, the pulse pump, the sensor system and the internal monitoring system being communicatively connected to the computer control system.

10. The animal in-vitro heart-based interventional operation in-vitro simulation system of claim 5, wherein each interface is connected with the animal in-vitro heart in a specific manner as follows:

the heart in vitro of the animal is provided with an opening with a preset size, each interface is inserted into the opening, and the opening and each interface are restrained by a restraining piece.

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