CN116173394A

CN116173394A - Ventricular assist device

Info

Publication number: CN116173394A
Application number: CN202111460905.3A
Authority: CN
Inventors: 黄霖
Original assignee: Shanghai Xinhengrui Medical Technology Co ltd
Current assignee: Shanghai Xinhengrui Medical Technology Co ltd
Priority date: 2021-11-29
Filing date: 2021-11-29
Publication date: 2023-05-30
Also published as: WO2023093478A1

Abstract

The invention provides a ventricular assist device, which comprises a pressing bag, a regulating bag and a sheath, wherein the pressing bag is used for wrapping at least part of the outer wall of a heart so as to assist a ventricle to contract or expand, and the regulating bag is used for wrapping at least part of the pressing bag so as to regulate the position of the pressing bag; the sheath wraps at least part of the regulating bladder, wherein the interior of the pressing bladder is used for storing working medium, and the interior of the regulating bladder is used for storing regulating medium. The heart of different patients can be wrapped by the pressing bag of the ventricular assist device, and the position of the pressing bag can be adjusted by the adjusting bag after the heart is reconstructed, so that the pressing bag can be re-attached to the outer wall of the heart after the heart is reconstructed, and the pressing bag can be used for effectively pressing the heart chamber all the time, so that the long-term treatment effect of the ventricular assist device is ensured.

Description

Ventricular assist device

Technical Field

The invention relates to the technical field of medical equipment, in particular to a ventricular assist device.

Background

Ventricular assist devices are mechanical devices made of artificial materials that can temporarily or permanently replace the pumping function of the heart to reduce heart load and assist the heart in achieving blood circulation, and are now becoming an important medical tool for treating heart failure and for extending life. Ventricular assist devices can be classified into blood direct contact ventricular assist devices and non-blood direct contact ventricular assist devices. The current direct-contact ventricular assist device for blood generally adopts a pulsating film pump and a constant flow pump (such as an axial flow pump and a centrifugal pump) to directly apply work to blood flow, so that the flow speed and the pressure of the blood flow are improved, and the assist to the ventricular compression function is realized. However, this type of ventricular assist device has some components (such as pump housing, impeller, suction line, etc.) that are in direct contact with human blood and output driving force to the blood, which would risk blood compatibility (e.g., coagulation and hemolysis); meanwhile, after the ventricular assist device is implanted, the patient is more likely to suffer from adverse events such as peripheral arterial thrombosis, visceral hemorrhage, death and the like.

The above problems with blood direct contact type ventricular assist devices have been studied by many companies and scientific institutions in recent years. Common non-blood contact ventricular assist devices typically have a sheath that is wrapped around the outer wall of the heart and a compression balloon is positioned between the outer wall of the heart and the sheath. The pressing bag is filled with compressed air, and is tightly attached to the outer wall of the heart, and expands or contracts under the drive of the compressed air so as to realize the pressing of the pressing bag on the ventricle. However, since the shape of the sheath is generally fixed, after the ventricular assist device is implanted into a human body, the heart of the patient will be reconstructed, that is, the volume and shape of the heart of the patient will be changed, and the sheath and the pressing bag with the relatively fixed shapes cannot be fully attached to the reconstructed outer wall of the heart at this time, so that the pressing effect on the ventricle will be affected, and the treatment effect of the ventricular assist device is further affected. Meanwhile, the geometric model of the sheath is obtained by reversely reconstructing image data of the heart of each patient, and because the heart shape of each patient is different, the sheath size obtained by each patient according to the heart image data is also different, and the customized preparation mode of the sheath ensures that the production efficiency of the sheath is lower, the standardized and batched production is difficult, and the production cost is higher; the sheath is prepared after the heart image data are acquired by the patient, and the patient often needs longer waiting time before the operation, so that the treatment period of the patient diseases can be improved, the psychological burden of the patient is increased, the patient disease condition can be worsened, and even the patient is disabled or dead.

There is therefore a need for a ventricular assist device that can be adapted to different patients and that can effectively compress the heart after its reconstruction.

Disclosure of Invention

The invention aims to provide a ventricular assist device, wherein a pressing bag of the ventricular assist device can cover the outer walls of hearts of different patients, and an adjusting bag can adjust the positions of the pressing bags after the hearts are reconstructed, so that the pressing bags can be closely attached to the outer walls of the hearts after the hearts are reconstructed, and the pressing bags can always and effectively press ventricles, thereby ensuring the long-term treatment effect of the ventricular assist device.

To achieve the above object, the present invention provides a ventricular assist device including a compression balloon, a regulation balloon, and a sheath; the pressing bag is used for wrapping at least part of the outer wall of the heart so as to assist the ventricle to contract or expand; the adjusting bag is coated on at least part of the pressing bag so as to adjust the position of the pressing bag, and the sheath is coated on at least part of the adjusting bag; the pressing bag is internally used for storing working media, and the adjusting bag is internally used for storing adjusting media.

Optionally, the quantity of regulation bag is a plurality of, and a plurality of regulation bag all cladding is in press the bag and set up mutually independently, in order to adjust press the position in the different regions of bag.

Optionally, the ventricular assist device further comprises a delivery catheter having a plurality of delivery channels, a plurality of the delivery channels communicating with a corresponding one of the modulation bladders, and different modulation bladders communicating with different delivery channels.

Optionally, the delivery catheter comprises a first catheter, a distal end of the first catheter being connected to the adjustment balloon;

the first catheter is a single-cavity tube, the number of the single-cavity tubes is multiple, and the single-cavity tubes are connected with different regulating bags, or the first catheter is a multi-cavity tube, the number of the first catheter is one, and the multiple cavities in the multi-cavity tube are connected with different regulating bags.

Optionally, the delivery catheter further comprises a connection interface, the proximal end of the first catheter being connected to the connection interface;

when the first catheter is a single-cavity tube, the proximal end of each single-cavity tube is connected with one connecting interface;

when the first catheter is a multi-lumen tube, the proximal end of each lumen of one of the multi-lumen tubes is connected to one of the connection interfaces.

Optionally, the connection interface is provided with an openable sealing part; the closed sealing part is used for sealing the first catheter; the opened sealing part is used for allowing an external injection component to pass through, and the external injection component is used for injecting or extracting the regulating medium into the regulating capsule.

Optionally, the seal is made of a septum that can be pierced by the external injection member and that can also be closed automatically after piercing.

Optionally, the pressing bag comprises a first film and a second film, a closed first cavity is formed between the first film and the second film, and the first cavity is used for storing the working medium; the regulating bag comprises a second film and a third film, wherein a closed second cavity is formed between the second film and the third film, and the second cavity is used for storing the regulating medium.

Optionally, the ventricular assist device further comprises a delivery catheter, a delivery device, and a control device, wherein the control device is in communication connection with the delivery device, and the delivery device is connected with the delivery catheter;

the delivery catheter includes a first catheter and a second catheter; the distal end of the first catheter is connected with the regulating bag, and the proximal end of the first catheter is connected with the conveying device; the distal end of the second catheter is connected with the pressing bag, and the proximal end of the second catheter is connected with the conveying device;

wherein the control device is used for controlling the conveying device to inject or extract the adjusting medium into the adjusting bag through the first catheter according to the received cardiac radiography data; and/or the control device is used for controlling the conveying device to inject or extract the working medium into the pressing capsule through the second catheter according to the received cardiac radiography data.

Optionally, the pressing bag comprises a working bag and a supporting bag which are independently arranged; the working balloon is used to assist in contracting or expanding the ventricle and the support balloon is used to secure at least a portion of the outer wall of the heart.

Optionally, the number of the working bags and the supporting bags is multiple, and multiple working bags and multiple supporting bags are arranged on the outer wall of the ventricle at intervals and are not overlapped with each other.

Optionally, the working balloon and the support balloon are configured to be alternately disposed in a circumferential direction of an outer wall of the ventricle.

The ventricular assist device provided by the invention can regulate the position of the pressing bag after the heart is reconstructed by regulating the bag, so that the pressing bag can be closely attached to the outer wall of the heart after the heart is reconstructed, and the pressing bag can be used for effectively pressing the ventricle all the time after the heart is reconstructed, thereby ensuring the long-term treatment effect of the ventricular assist device. In addition, because the position of pressing the bag can be adjusted to the regulation bag, so can make the same specification press the bag and can wrap up and press the heart outer wall of different patients, and then can realize ventricular assist device's normalization and mass production, so can effectively reduce ventricular assist device's manufacturing cost to promote production efficiency. In addition, the normalized pressing bag has no customized production period, and can be implanted at any time when a patient needs, so that the waiting time before the operation of the patient can be effectively reduced, the deterioration of the disease condition of the patient can be avoided, and the risks of disability and death of the patient can be effectively reduced.

Drawings

FIG. 1 is a schematic view of a central room auxiliary device according to a preferred embodiment of the present invention;

FIG. 2 is a schematic view of the state of the heart, the regulator cuff and the compression cuff with the heart in diastole, showing a cross-sectional view of the heart chamber, in accordance with a preferred embodiment of the present invention;

fig. 3 is a schematic view showing the states of the heart, the regulator balloon and the compression balloon when the heart is in systole, according to a preferred embodiment of the invention, wherein a cross-sectional view of the ventricle is shown.

In the figure: a pressing bag 1; a working bladder 11; a support cell 12; a heart 2; a ventricle 21; a left ventricle 211; a right ventricle 212; a regulating bladder 3; a first conduit 41; a connection interface 42; a first film 51; a second film 52; a sheath 53; a second conduit 6; and a control device 7.

Detailed Description

The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.

The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. In the description of the present invention, "plurality" means at least two, for example, two or three or more, etc. In the description of the present invention, "proximal" generally refers to the end that is proximal to the operator; "distal" is the end opposite "proximal" and generally refers to the end that is remote from the operator, i.e., the end that first enters the body. In the description of the present invention, "circumferential of the ventricular outer wall" refers to a direction around the left ventricle and the right ventricle.

The invention will now be described in detail with reference to the drawings and a preferred embodiment. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

As shown in fig. 1 to 3, a preferred embodiment of the present invention provides a ventricular assist device comprising a compression balloon 1, a conditioning balloon 3, and a sheath 53, the compression balloon 1 being adapted to cover at least part of the outer wall of a heart 2 to assist in contracting or expanding a ventricle 21. The adjustment bladder 3 encloses at least part of the compression bladder 1 to adjust the position of the compression bladder 1, and the envelope 53 encloses at least part of the adjustment bladder 3. Wherein the pressing capsule 1 has a closed first cavity for storing a working medium; the conditioning bladder 3 has a closed second cavity for storing a conditioning medium. In general, the compression balloon 1 mainly covers the myocardial tissue outer wall (i.e., the ventricular outer wall) of the ventricle 21, so configured that the ventricle 21 can be assisted to be compressed by injecting or extracting a working medium into the compression balloon 1 to assist the heart to achieve blood circulation; meanwhile, the adjusting bag 3 is arranged on the outer side of the pressing bag 1, which is away from the heart, and the position of the pressing bag 1 can be adjusted by injecting or extracting an adjusting medium into the adjusting bag 3, namely, the adjusting bag 3 can press the pressing bag 1, so that the pressing bag 1 can be closely attached to the outer wall of the heart 2 at any time.

In more detail, in the prior art, after the ventricular assist device is implanted in the body, since the volume and shape of the heart of the patient will change, the sheath 53 and the compression balloon 1, which are relatively fixed in shape, cannot sufficiently conform to the reconstructed outer wall of the heart. In the present invention, after the above ventricular assist device is implanted in the body, if the volume of the heart becomes smaller, the volume of the regulating bag 3 is enlarged by injecting the regulating medium into the regulating bag 3, and the pressing bag 1 is pushed to move toward the ventricle 21, so that the pressing bag 1 is closely attached to the outer wall of the heart 2 again; if the volume of the heart becomes larger, the volume of the regulating bag 3 can be reduced by extracting the regulating medium in the regulating bag 3, and the pressing bag 1 can move in the direction away from the ventricle 21, so that the pressing of the pressing bag 1 to the outer wall of the heart 2 is reduced, and meanwhile, the tight contact between the pressing bag 1 and the outer wall of the heart 2 is ensured; so configured, the compression balloon 1 can be ensured to be capable of always effectively compressing the ventricle 21 after the heart is reconstructed, and the long-term treatment effect of the ventricular assist device is ensured. Through the above-mentioned regulatory action of regulating bag 3, the cover 53 of same specification and press bag 1 can carry out cladding and press to different patient's heart 2, and then can realize ventricular assist device's normalization and mass production, so can effectively reduce ventricular assist device's manufacturing cost, promote production efficiency. In addition, the normalized production sheath 53 and compression balloon 1 have no customized production cycle and can be implanted at any time when needed by the patient, thereby effectively reducing the waiting time of the patient before surgery, avoiding the deterioration of the patient's condition and effectively reducing the risk of patient disability and mortality.

In addition, the working medium and the regulating medium mainly adopt gas or liquid with better fluidity, so that the pressure of each area of the pressing bag 1 and the regulating bag 3 can be regulated more efficiently, and the regulating efficiency of the ventricular assist device and the ventricular pressing efficiency are improved. The types of the working medium and the regulating medium are not limited in the application, and the gas includes but is not limited to nitrogen, helium or compressed air, and the liquid includes but is not limited to pure water or physiological saline. In addition, the kinds of the working medium and the adjusting medium may be the same or different.

Further, the pressing bag comprises a first film and a second film, a closed first cavity is formed between the first film and the second film, and the first cavity is used for storing a working medium; the conditioning bladder comprises a second membrane and a third membrane (not shown in the figures) forming a closed second cavity between them for storing conditioning medium. In the present embodiment, the compression balloon 1 includes a first film 51 and a second film 52, a first cavity is formed between the first film 51 and the second film 52, at this time, the first film 51 is used to directly abut against the outer wall of the heart 2 and constitute the inner wall of the compression balloon 1, and the second film 52 is used to directly contact the adjustment balloon 3 and constitute the outer wall of the compression balloon 1. The regulating bladder 3 comprises a second membrane 52 and a sheath 53, wherein a second cavity is formed between the second membrane 52 and the sheath 53, and the second membrane 52 forms the inner wall of the regulating bladder 3 and the sheath 53 forms the outer wall of the regulating bladder 3. In this example, the wrap 53 is preferably a third film. Of course, in other embodiments, the sheath 53 and the third film may be separate films. In this embodiment, the second film 52 is preferably shared by the regulating bladder 3 and the pressing bladder 1, so configured that the regulating bladder 3 can effectively transmit the pressure generated by the volume change of itself to the pressing bladder 1, and the regulating bladder 3 can efficiently adjust the position of the pressing bladder 1, thereby ensuring that the pressing bladder 1 can be closely attached to the outer wall of the heart 2 all the time after the heart is reconstructed, so configured that the transmission of the pressure of the pressing bladder 1 and the regulating bladder 3 can be better realized. Of course, in other embodiments, the regulating bladder 3 and the pressing bladder 1 may not share the second film 52, but may be separate films.

It should be understood that the pressing bag 1 and the adjusting bag 3 may be integrally formed by a whole film, or may be formed by splicing different films. The manufacturing methods of the pressing bag 1 and the regulating bag 3 are not limited in the present application. In addition, the materials of the first film 51, the second film 52, the third film, and the sheath 53 are not limited in this application. For example, the first film 51 may be a flexible film capable of directly contacting the cardiac muscle, for example, made of a soft and fatigue-resistant silica gel, a low-hardness TPU, or the like; the second film 52 may be made of a high-hardness elastic plastic, for example, PU, TPU, PVC. The second film 52 is preferably provided as a multi-layered film structure comprising a flexible tensile reinforcement layer (e.g., nylon filaments, pebax). The third film or sheath 53 may be made of an elastic plastic or metal material having high tensile rigidity and strength, for example, PU, TPU, PVC, or nickel-titanium alloy, stainless steel, or ultra-high molecular weight polyethylene. The third film or sheath 53 is preferably a multi-layered film structure with a matrix of PU, TPU or PVC and comprising a reinforcing mesh of higher stiffness of nitinol, stainless steel or ultra high molecular weight polyethylene, etc., so arranged that the outer wall of the conditioning bladder 3 has a higher stiffness and is capable of spacing the conditioning bladder 3. Since the inner wall of the regulating bladder 3 is small in rigidity, when the regulating medium is injected into the regulating bladder 3, the regulating bladder 3 can be inflated only in the direction of the pressing bladder 1, and cannot be inflated in the direction of the envelope 53, so that the regulating bladder 3 can apply pressure to the pressing bladder 1. The present application is not limited to the structure of the sheath 53, and the sheath 53 may be provided as a support net, a support sleeve, or other type of support structure.

Preferably, the number of the adjusting bags 3 is multiple, and the adjusting bags 3 are all coated on the pressing bag 1, and the adjusting bags 3 are independently arranged at positions corresponding to the left ventricle 211 and/or the right ventricle 212 to adjust positions of different areas of the pressing bag 1 and realize non-uniform adjustment of the pressing bag 1, so that the adjusting efficiency of the pressing bag 1 is higher, and the pressing effect on the ventricle 21 is better. Specifically, after implantation of the ventricular assist device, as the heart of the patient may be reconfigured, the reconfigured heart 2 may be separated from a part of the area of the compression balloon 1, and the plurality of independent adjustment balloons 3 may be provided to adjust only the area of the compression balloon 1 separated from the outer wall of the heart 2, without adjusting all the areas of the compression balloon 1 covered by the adjustment balloon 3, so that the adjustment is accurate and the adjustment efficiency is high.

It should be appreciated that in some embodiments, a plurality of independent adjustment bladders 3 may be continuously disposed on the outer wall of compression bladder 1, i.e., a plurality of independent adjustment bladders 3 may be continuously aligned on the outer wall of compression bladder 1 and not overlap each other; at this time, a plurality of adjustment pockets 3 may be provided on the outer wall of the pressing pocket 1 to adjust the position of any region of the pressing pocket 1. In other embodiments, a plurality of independent adjusting bladders 3 may be disposed at intervals on the outer wall of the pressing bladder 1, and the adjusting bladders 3 may be disposed at partial areas of the pressing bladder 1 as needed, and adjust the positions of the partial areas of the pressing bladder 1.

In other embodiments, the number of the adjusting bags 3 may be one, and one adjusting bag 3 is coated on at least part of the outer wall of the pressing bag 1, and the area of the pressing bag 1 coated with the adjusting bag 3 may be adjusted at the same time.

In a preferred embodiment, the ventricular assist device further comprises a delivery catheter having a plurality of delivery channels, the plurality of delivery channels being in communication with a corresponding one of the adjustment bladders 3, and different ones of the adjustment bladders 3 being in communication with different ones of the delivery channels, the adjustment medium being delivered to a corresponding one of the adjustment bladders 3 through the plurality of delivery channels, thereby effecting zonal adjustment of the compression bladder 1 and increasing flexibility of adjustment.

Referring to fig. 1 and 2, the delivery catheter includes a first catheter 41, the distal end of the first catheter 41 is connected to the regulating balloon 3, and the first catheter 41 may be configured as a single lumen tube or a multi-lumen tube. In an embodiment, the first catheter 41 is a single-lumen tube, the number of the single-lumen tubes is multiple, and the multiple single-lumen tubes are connected with different adjusting bags 3 to respectively control the pressure of the different adjusting bags 3, and the multiple adjusting bags 3 can respectively apply pressure to different areas of the pressing bag 1, so that the positions of the different areas of the pressing bag 1 can be flexibly adjusted. In another embodiment, the first catheter 41 is a multi-lumen tube, and a plurality of lumens in one multi-lumen tube are connected with different regulating bags 3, so that the regulating mediums can be injected or extracted into different regulating bags 3 at the same time, thereby improving the conveying efficiency of the conveying catheter.

With continued reference to fig. 1, the delivery catheter further includes a connection interface 42, with the proximal end of the first catheter 41 being connected to the connection interface 42. Preferably, the connection interface 42 can be directly connected to an external injection component, which injects or extracts the conditioning medium into the conditioning bladder 3 via the first conduit 41.

When the first catheter 41 is a single lumen tube, the proximal end of each single lumen tube is preferably connected to a connection interface 42. In an embodiment, the number of the first conduits 41 is plural, and the number of the connection interfaces 42 is plural, so that the external injection component can respectively inject or extract the adjusting medium into the corresponding one of the adjusting bladders 3 through the different connection interfaces 42 to respectively control the different adjusting bladders 3; of course, in other embodiments, the number of first conduits 41 may be one, in which case the conditioning medium may be fed into the conditioning bladder 3 via a connection interface 42.

When the first catheter 41 is a multi-lumen tube, the proximal end of each lumen of one of the multi-lumen tubes is preferably connected to a connection interface 42. In a preferred embodiment, the number of the regulating bags 3 is multiple, the end of the multi-cavity tube connected with the connecting interface 42 can be provided with one or more cavities and one or more connecting interfaces 42, and the external injection component can deliver the regulating medium to different regulating bags 3 through one or more connecting interfaces 42 so as to further improve the delivery efficiency of the regulating medium.

Preferably, the connection port 42 is provided with an openable and closable sealing portion (not shown), the sealing portion after closing being used for plugging the first conduit 41, the sealing portion after opening being used for passing through an external injection member, and the external injection member being used for injecting or extracting the adjusting medium into the adjusting bag 3. In one example, the seal is made of a septum that can be pierced by an external injection member and that can be automatically closed after piercing, thus allowing the connection interface 42 to be simple in construction, convenient to use and leak-proof. In particular, the external injection component is typically an injection needle, the connection interface 42 is typically an injectable seat, which is typically implanted subcutaneously, the injection needle being able to penetrate a septum on the seat and to inject or withdraw the conditioning medium into or from the conditioning bladder 3.

In a preferred embodiment, the ventricular assist device further comprises a delivery device (not shown) and a control device 7, the delivery device being communicatively coupled to the control device 7, the delivery device being coupled to the delivery catheter. The delivery catheter further comprises a second catheter 6, the distal end of the second catheter 6 being connected to the compression balloon 1.

As an example, the control means 7 are adapted to control the delivery means to inject or extract a working medium through the second catheter 6 into the compression balloon 1 in order to assist the contraction and expansion of the ventricle 21, based on the received cardiac contrast data.

As an example, the control means 7 are arranged to control the delivery means to inject or extract a conditioning medium into or from the conditioning bladder 3 via the first catheter 4 in dependence on the received cardiac contrast data, in order to adjust the pressure exerted by the conditioning bladder 3 on the compression bladder 1.

Optionally, the control device 7 further comprises a pressure detection device, which can detect the pressure of the compression balloon 1 and the adjustment balloon 3 in real time, so that the compression adjustment of the ventricle 21 is more accurate and the auxiliary effect is better. Specifically, an electrode may be disposed on at least one of the first film 51, the second film 52, the third film and the sheath 53, and the pressure detecting device may obtain the pressures of the regulating bladder 3 and the pressing bladder 1 according to the cardiac radiography data detected by the electrode, so as to obtain the degree of pressing between the regulating bladder 3, the pressing bladder 1 and the outer wall of the ventricle 21, so that the ventricular assist device can assist the ventricle 21 more accurately and efficiently. The type of pressure detection device is not limited, as including but not limited to a pressure sensor.

In a specific embodiment, the second catheter 6 may be passed through the chest wall, where a portion of the second catheter 6 is disposed in the patient and another portion is disposed outside the patient, so that the control device 7 may be disposed outside the patient, thereby facilitating the acquisition of the patient's cardiac contrast data by the operator.

In one embodiment, the control device 7 and the delivery device may be provided separately, in which case the delivery device may be provided in or outside the patient's body and in communication with the control device 7. In another embodiment, the delivery device may also be integrated within the control device 7 to simplify the construction of the ventricular assist device.

In a specific embodiment, the delivery device comprises a fluid pump, and further may comprise a valve. The control device 7 can control the opening or closing of the valve according to the cardiac radiography data and control the conveying state of the fluid pump, so that the conveying device can inject or extract working medium into the pressing bag 1, and the pressing bag 1 can assist the contraction or expansion of the ventricle 21. In a specific embodiment, the control device 7 may control the delivery device to periodically or intermittently deliver the working medium to the compression balloon 1 to achieve compression of the ventricle 21.

In more detail, the delivery cycle of the delivery device may be set according to the cardiac contrast data of the patient, for example when the cardiac contrast data reaches a peak, as shown with reference to fig. 3, the control device 7 may control the delivery device to inject a working medium into the working bladder 11 to assist the ventricle 21 to complete the contraction; when the cardiac contrast data reaches the trough, as shown in fig. 2, the control device 7 may control the delivery device to withdraw the working medium from the working sac 11 to assist the ventricle 21 to complete the dilation; thus, the working bladder 11 assists in achieving normal contraction and expansion of the heart chamber 21. It should be appreciated that the number and frequency of the ventricular assist device assist to the ventricle 21 may be set as desired, i.e., the ventricular assist device may assist each time the ventricle 21 contracts and expands, or may assist only once or a small number of times when the ventricle 21 completes multiple contractions and expansions.

Referring to fig. 1 to 3, in a preferred embodiment, the compression balloon 1 includes a working balloon 11 and a support balloon 12 that are independently provided (i.e., not in communication with each other); the working bag 11 is used for assisting the ventricle 21 to contract or expand, the supporting bag 12 is used for fixing at least part of the outer wall of the heart 2, and the outer wall of the ventricle 21 which needs to contract or expand is generally fixed, so that the heart 2 can be prevented from twisting or shifting under the pressing of the working bag 11, and the pressing effect of the ventricle 21 is ensured. It will also be appreciated that in order to enable the support cells 12 to effectively secure the outer wall of the heart 2, the pressure within the support cells 12 remains constant throughout the time of use, while the working cells 11 can adjust their internal pressure at any time in accordance with the cardiac imaging data to periodically compress the heart chambers 21.

The number of the working cells 11 and the support cells 12 is not limited in the present application, the number of the working cells 11 and the support cells 12 may be one or more, and the number of the working cells 11 and the support cells 12 may be the same or different. Preferably, the number of the working bags 11 and the supporting bags 12 is plural, and the working bags 11 and the supporting bags 12 are arranged at intervals on the outer wall of the ventricle and are not overlapped with each other. The relative positional relationship between the working bladder 11 and the support bladder 12 is not particularly limited in this application, and in general, the working bladder 11 and the support bladder 12 may be used to be alternately disposed in the circumferential direction of the ventricular outer wall.

The present application is not limited to the manner in which the working cells 11 and the support cells 12 are alternately arranged, and for example, at least one working cell 11 may be disposed between two adjacent support cells 12, and for example, at least one support cell 12 may be disposed between two adjacent working cells 11. So configured, on the one hand, a plurality of working chambers 11 can be distributed in corresponding areas of the left ventricle 211 and the right ventricle 212, so that the respective pressing of the left ventricle 211 and the right ventricle 212 can be realized by injecting or extracting working mediums into different working chambers 11; on the other hand, the spaced arrangement of the support cells 12 may form a plurality of fixation areas on the outer wall of the heart 2, thereby further securing the heart 2.

Referring to fig. 2 and 3, in the present embodiment, the number of the working cells 11 and the supporting cells 12 is 3, and the working cells 11, the supporting cells 12, the working cells 11, the supporting cells 12 are arranged on the outer walls of the corresponding left ventricle 211 and right ventricle 212 in an alternating manner, that is, one supporting cell 12 is arranged between every two adjacent working cells 11, so that the treatment requirement can be basically satisfied. Of course, in other embodiments, 2 or more support cells 12 may be provided between each adjacent two of the working cells 11.

Further, the control device 7 may control the states (mainly pressures) of the plurality of working chambers 11 by the delivery device, respectively, and the states of the plurality of working chambers 11 may be different or the same to precisely control the pressures applied to the left ventricle 211 and the right ventricle 212.

When the number of working balloons 11 is plural, the second catheter 6 may be a single lumen tube or a multi-lumen tube. In an embodiment, the second catheter 6 is a single lumen tube, the number of the second catheters 6 is multiple, and the multiple second catheters 2 can be respectively connected with a corresponding working sac 11, and at this time, the conveying device can respectively and independently inject or extract working medium into each working sac 11 so as to realize respective pressing on different ventricles 21. In another embodiment, the second catheter 6 is a multi-lumen tube, and the number of the second catheters 6 is one, and the multiple cavities in one second catheter 2 can be connected with different working bags 11, so that the conveying device can convey the working medium into the multiple working bags 11 only through one second catheter 6, and the conveying efficiency of the working medium can be improved.

The operation of the ventricular assist device is further described in connection with the preferred embodiment.

Generally, as shown in fig. 1-3, after the ventricular assist device is implanted in the patient, the control device 7 may acquire cardiac angiography data of the patient and control the delivery device to periodically inject or withdraw a working medium into or from the working sac 11 to assist contraction or expansion of the ventricle 21; after the ventricular assist device is implanted for a period of time, the patient will be subjected to CT radiography periodically, the doctor will compare the CT radiography data of the time with the last CT radiography data, if the patient is subjected to CT radiography for the time to show that the size of the heart 2 is changed, the doctor will inject or extract the adjusting medium into the adjusting bag 3 according to the changed size data of the heart 2, and at this time, the pressing bag 1 can move towards the outer wall of the heart under the driving of the adjusting bag 3 until being closely attached to the outer wall of the heart 2 again.

The type of the control device 7 is not particularly limited, and may be hardware for performing a logic operation, for example, a single chip microcomputer, a microprocessor, a programmable logic controller (PLC, programmable Logic Controller) or a Field programmable gate array (FPGA, field-Programmable Gate Array), or a software program, a function module, a function, a target library (Object Libraries) or a Dynamic Link library (Dynamic-Link Libraries) for realizing the above functions on a hardware basis. It should be understood how the communication between the control means 7 and other devices is embodied.

In summary, the ventricular assist device provided by the invention can adjust the position of the pressing bag 1 through the adjusting bag 3 after the heart 2 is reconstructed, so that the pressing bag 1 can be closely attached to the outer wall of the reconstructed heart 2, and after the heart is reconstructed, the pressing bag 1 can always effectively press the ventricle 21, thereby ensuring the long-term treatment effect of the ventricular assist device. In addition, because the position of pressing the bag 1 can be adjusted to adjust the bag 3, so can make the pressing bag 1 of same specification carry out cladding and pressing to the heart outer wall of different patients, and then can realize ventricular assist device's normalization and mass production, so can effectively reduce ventricular assist device's manufacturing cost to promote production efficiency. In addition, the normalized pressing capsule 1 has no customized production cycle, and can be implanted at any time when a patient needs, so that the waiting time before the operation of the patient can be effectively reduced, the deterioration of the illness state of the patient can be avoided, and the risks of disability and death of the patient can be effectively reduced.

The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.

Claims

1. A ventricular assist device comprising a compression balloon, a conditioning balloon, and a sheath; the pressing bag is used for wrapping at least part of the outer wall of the heart so as to assist the ventricle to contract or expand; the adjusting bag is coated on at least part of the pressing bag so as to adjust the position of the pressing bag, and the sheath is coated on at least part of the adjusting bag;

the pressing bag is internally used for storing working media, and the adjusting bag is internally used for storing adjusting media.

2. The ventricular assist device of claim 1 wherein the number of said adjustment bladders is a plurality, and wherein a plurality of said adjustment bladders are wrapped around said compression bladder and are disposed independently of one another to adjust the position of different regions of said compression bladder.

3. The ventricular assist device of claim 2 further comprising a delivery conduit having a plurality of delivery channels, a plurality of the delivery channels communicating with a corresponding one of the modulation bladders, and different modulation bladders communicating with different delivery channels.

4. A ventricular assist device as claimed in claim 3 wherein the delivery catheter comprises a first catheter, a distal end of the first catheter being connected to the modulation balloon;

5. The ventricular assist device of claim 4 wherein the delivery catheter further comprises a connection interface, the proximal end of the first catheter being connected to the connection interface;

6. The ventricular assist device of claim 5 wherein the connection interface is provided with an openable and closable seal; the closed sealing part is used for sealing the first catheter; the opened sealing part is used for allowing an external injection component to pass through, and the external injection component is used for injecting or extracting the regulating medium into the regulating capsule.

7. A ventricular assist device as claimed in claim 6 wherein the seal is made of a septum which is pierceable by the external injection member and is also capable of self-closing after piercing.

8. The ventricular assist device of claim 1 wherein the compression balloon comprises a first membrane and a second membrane forming a closed first cavity therebetween, the first cavity for storing the working medium; the regulating bag comprises a second film and a third film, wherein a closed second cavity is formed between the second film and the third film, and the second cavity is used for storing the regulating medium.

9. The ventricular assist device of claim 1, further comprising a delivery catheter, a delivery device, and a control device, the control device communicatively coupled to the delivery device, the delivery device coupled to the delivery catheter;

10. The ventricular assist device of claim 1 wherein the compression balloon comprises a working balloon and a support balloon that are independently disposed; the working balloon is used to assist in contracting or expanding the ventricle and the support balloon is used to secure at least a portion of the outer wall of the heart.

11. The ventricular assist device of claim 10 wherein the number of said working and support balloons is a plurality, a plurality of said working and support balloons being spaced apart and non-overlapping on the outer wall of the ventricle.

12. The ventricular assist device of claim 11, wherein the working bladder and the support bladder are configured to be alternately disposed in a circumferential direction of an outer wall of a ventricle.