WO2023093478A1 - 心室辅助装置 - Google Patents

心室辅助装置 Download PDF

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Publication number
WO2023093478A1
WO2023093478A1 PCT/CN2022/129250 CN2022129250W WO2023093478A1 WO 2023093478 A1 WO2023093478 A1 WO 2023093478A1 CN 2022129250 W CN2022129250 W CN 2022129250W WO 2023093478 A1 WO2023093478 A1 WO 2023093478A1
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WO
WIPO (PCT)
Prior art keywords
catheter
capsule
regulating
pressing
bag
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PCT/CN2022/129250
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English (en)
French (fr)
Inventor
黄霖
Original Assignee
上海心恒睿医疗科技有限公司
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Publication of WO2023093478A1 publication Critical patent/WO2023093478A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/191—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/289—Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a ventricular assist device.
  • Ventricular assist device is a mechanical device made of artificial materials. Ventricular assist device can temporarily or permanently replace the pumping function of the heart to reduce the load on the heart and assist the heart to achieve blood circulation. It has become an important treatment for heart failure and life extension. Medical means. Ventricular assist devices can be divided into direct blood contact ventricular assist devices and non-blood direct contact ventricular assist devices.
  • the current blood direct contact ventricular assist device usually uses a pulsating membrane pump and a constant flow pump (such as an axial flow pump, a centrifugal pump) to directly perform work on the blood flow, thereby increasing the flow rate and pressure of the blood flow, so as to realize the compression function of the ventricle. auxiliary.
  • this type of ventricular assist device has some components (such as pump casing, impeller, suction line, etc.) that are in direct contact with human blood and output driving force to the blood, so it will have blood compatibility (such as coagulation and hemolysis) ) risk; at the same time, after implantation of this type of ventricular assist device, patients are also more prone to adverse events such as peripheral arterial thrombosis, visceral hemorrhage, and even death.
  • blood compatibility such as coagulation and hemolysis
  • a common non-blood-contacting ventricular assist device usually has a sheath that can cover the outer wall of the heart, and a pressing bag is arranged between the outer wall of the heart and the sheath.
  • the pressing bag is filled with compressed air, and the pressing bag is closely attached to the outer wall of the heart. Driven by the compressed air, the pressing bag expands or contracts, so as to realize the pressing of the pressing bag to the ventricle.
  • the shape of the sheath is usually relatively fixed, after the ventricular assist device is implanted into the human body, the patient's heart will undergo remodeling, that is, the volume and shape of the patient's heart will change. And the compression bag cannot fully fit the remodeled outer wall of the heart, which will affect the compression effect on the ventricle, and then affect the therapeutic effect of the ventricular assist device.
  • the geometric model of the envelope is obtained by reverse reconstruction of the image data of the patient's heart. Since the shape of each patient's heart is different, the size of the envelope obtained by each patient based on the heart image data is also different.
  • the customized preparation method of the sheath makes the production efficiency of the sheath low and it is difficult to carry out standardized and mass production, and the production cost is high; and the sheath needs to be prepared after the patient collects the heart image data, and the patient should be prepared before the operation. It often requires a long waiting time, which can increase the treatment cycle of the patient's disease, increase the psychological burden of the patient, and may also lead to the deterioration of the patient's condition, and even cause the patient's disability or death.
  • a ventricular assist device that is applicable to different patients and can effectively compress the heart after the heart is remodeled.
  • the purpose of the present invention is to provide a ventricular assist device, the pressing bag of the ventricular assisting device can cover the outer wall of the heart with different shapes for different patients, and the adjusting bag can adjust the position of the pressing bag after the heart is remodeled , so that the compression capsule can be closely attached to the outer wall of the remodeled heart again, so that the compression capsule can always effectively press the ventricle, thereby ensuring the long-term therapeutic effect of the ventricular assist device.
  • the present invention provides a ventricular assist device, comprising a pressing bag, an adjusting bag and a sheath; the pressing bag is used to cover at least part of the outer wall of the heart to assist the ventricle to contract or expand; the regulating bag Coating at least part of the pressing bag to adjust the position of the pressing bag, the wrapping covering at least part of the regulating bag; wherein, the inside of the pressing bag is used to store the working medium, and the inside of the regulating bag is Internally used to store conditioning media.
  • the plurality of adjustment capsules are all coated on the pressing capsule and are arranged independently of each other, so as to adjust the positions of different regions of the pressing capsule.
  • the ventricular assist device further includes a delivery catheter, the delivery catheter has a plurality of delivery channels, and the plurality of delivery channels communicate with a corresponding one of the adjustment sacs, and different adjustment sacs communicate with different delivery channels.
  • the delivery catheter includes a first catheter, and the distal end of the first catheter is connected to the regulating balloon;
  • the first catheter is a single-lumen tube, and the number of the single-lumen tubes is multiple, and the multiple single-lumen tubes are connected to different adjustment capsules, or the first catheter is a multi-lumen tube and the number is one , multiple lumens in one multi-lumen tube are connected to different regulating capsules.
  • the delivery catheter further includes a connection interface, and the proximal end of the first catheter is connected to the connection interface;
  • each single-lumen tube is connected to one connection interface
  • the proximal end of each lumen of one multi-lumen tube is connected to one of the connection interfaces.
  • connection interface is provided with an openable and closable sealing part; the closed sealing part is used to block the first conduit; the opened sealing part is used to allow external injection components to pass through , the external injection part is used to inject or extract the adjustment medium into the adjustment capsule.
  • the sealing part is made of a septum, which can be pierced by the external injection part and can also be automatically closed after piercing.
  • the press bag includes 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 to store the working medium;
  • the regulating bag includes the second film and the third film, and a closed second cavity is formed between the second film and the third film, and the second cavity is used to store the regulating medium.
  • the ventricular assist device further includes a delivery catheter, a delivery device, and a control device, the control device is communicatively connected to the delivery device, and the delivery device is connected to the delivery catheter;
  • the delivery catheter includes a first catheter and a second catheter; the distal end of the first catheter is connected to the regulating bladder, and the proximal end is connected to the delivery device; the distal end of the second catheter is connected to the pressing bladder, and the proximal end is connected The end is connected to the delivery device;
  • control device is used to control the delivery device to inject or extract the adjustment medium to the adjustment sac through the first catheter according to the received cardiac imaging data; and/or, the control device is used to According to the received cardiographic data, the delivery device is controlled to inject or extract the working medium from the pressing bladder through the second catheter.
  • the pressing bladder includes a working bladder and a supporting bladder which are independently arranged; the working bladder is used to assist the ventricle to contract or expand, and the supporting bladder is used to fix at least part of the outer wall of the heart.
  • the multiple working capsules and supporting capsules are arranged at intervals on the outer wall of the ventricle without overlapping each other.
  • the working capsules and the supporting capsules are arranged alternately in the circumferential direction of the outer wall of the ventricle.
  • the ventricular assist device provided by the present invention can adjust the position of the pressing capsule after heart remodeling by adjusting the capsule, so that the pressing capsule can be closely attached to the outer wall of the heart after remodeling, and after the heart is remodeled, the pressing capsule can The ventricle can be compressed effectively at all times, thus ensuring the long-term therapeutic effect of the ventricular assist device.
  • the adjusting bag can adjust the position of the pressing bag, the same specification of the pressing bag can cover and press the outer wall of the heart of different patients, thereby realizing the standardized and mass production of ventricular assist devices, which can effectively Reduce the production cost of ventricular assist devices and improve production efficiency.
  • Fig. 1 is an application scene diagram of a central ventricular assisting device in a preferred embodiment of the present invention
  • Fig. 2 is a schematic view of the state of the heart, the regulating sac and the pressing sac when the heart is in diastole in a preferred embodiment of the present invention, wherein it shows a cross-sectional view of the ventricle;
  • Fig. 3 is a schematic view of the state of the heart, the regulating sac and the pressing sac when the heart is in systole in a preferred embodiment of the present invention, in which a cross-sectional view of the ventricle is shown.
  • orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation or be configured in a specific orientation. and operation, and therefore should not be construed as limiting the invention.
  • proximal end usually refers to the end close to the operator; one end.
  • circumferential direction of the outer wall of the ventricle refers to the direction surrounding the left ventricle and the right ventricle.
  • a preferred embodiment of the present invention provides a ventricular assist device, which includes a pressing bag 1, an adjusting bag 3 and a sheath 53.
  • the pressing bag 1 is used to cover at least part of the outer wall of the heart 2, so as to The auxiliary ventricle 21 contracts or expands.
  • the regulating capsule 3 covers at least part of the pressing capsule 1 to adjust the position of the pressing capsule 1 , and the wrapping 53 covers at least part of the regulating capsule 3 .
  • the pressing capsule 1 has a closed first cavity for storing a working medium; the regulating capsule 3 has a closed second cavity for storing an adjusting medium.
  • the compression bag 1 mainly covers the outer wall of the myocardial tissue of the ventricle 21 (i.e., the outer wall of the ventricle).
  • the ventricle 21 can be assisted to be pressed by injecting or extracting a working medium into the compression bag 1, so as to assist the heart to realize blood circulation;
  • the adjustment capsule 3 is set on the outside of the compression capsule 1 away from the heart, and the position of the compression capsule 1 can be adjusted by injecting or extracting the adjustment medium into the adjustment capsule 3, that is, the adjustment capsule 3 can squeeze the compression capsule 1, so that the compression capsule 1 It can be closely attached to the outer wall of the heart 2 at any time.
  • the volume and shape of the patient's heart will change.
  • the relatively fixed shape of the sheath 53 and the compression bag 1 cannot be in contact with the remodeled outer wall of the heart. Full fit.
  • the regulating medium can be injected into the regulating capsule 3 to expand the volume of the regulating capsule 3, and push and press the capsule 1 toward the ventricle.
  • the regulating medium in the regulating capsule 3 can be extracted to reduce the volume of the regulating capsule 3 and make the
  • the compression bag 1 can move away from the ventricle 21, so as to reduce the extrusion of the compression bag 1 to the outer wall of the heart 2, and at the same time ensure that the compression bag 1 is closely attached to the outer wall of the heart 2; such a configuration can ensure that the compression bag 1 can be pressed against the outer wall of the heart 2.
  • the ventricle 21 is always effectively pressed to ensure the long-term therapeutic effect of the ventricular assist device.
  • the wrapping 53 and the pressing capsule 1 of the same specification can cover and press the hearts 2 of different patients, thereby realizing the standardized and mass production of ventricular assist devices, which can effectively reduce the Reduce the production cost of ventricular assist devices and improve production efficiency.
  • the standardized production sheath 53 and the pressing capsule 1 do not have a customized production cycle, and can be implanted at any time when the patient needs it, which can effectively reduce the patient's waiting time before surgery, avoid the deterioration of the patient's condition, and effectively Reduce the risk of patient disability and death.
  • the working medium and the regulating medium mainly use gas or liquid with better fluidity, so that the pressure in each area of the pressing bag 1 and the regulating bag 3 can be adjusted more efficiently, so as to improve the regulating efficiency of the ventricular assist device and the Compression efficiency.
  • the application does not limit the types of working medium and regulating medium, the gas includes but not limited to nitrogen, helium or compressed air, and the liquid includes but not limited to pure water or saline.
  • the types of the working medium and the regulating medium may be the same or different.
  • the pressing bag includes a first film and a second film, and a closed first cavity is formed between the first film and the second film, and the first cavity is used to store the working medium;
  • the regulating bag includes the second film and the third film.
  • a thin film (not shown in the drawings), a closed second cavity is formed between the second thin film and the third thin film, and the second cavity is used to store the regulating medium.
  • the compression bag 1 includes a first film 51 and a second film 52, and a first cavity is formed between the first film 51 and the second film 52.
  • the first film 51 is used to be directly attached to the heart 2
  • the outer wall of the pressing bag 1 constitutes the inner wall of the pressing bag 1
  • the second film 52 is used to directly contact the regulating bag 3 and constitutes the outer wall of the pressing bag 1.
  • the regulating bag 3 comprises a second film 52 and a wrapping 53, a second cavity is formed between the second film 52 and the wrapping 53, at this time, the second film 52 constitutes the inner wall of the regulating bag 3, and the wrapping 53 constitutes the regulating bag 3 the outer wall.
  • the wrapper 53 is the third film.
  • the wrapping 53 and the third film may be different films that are separately provided.
  • the regulating capsule 3 and the pressing capsule 1 share the second membrane 52, so that the regulating capsule 3 can effectively transmit the pressure generated by the volume change of itself to the pressing capsule 1, and the regulating capsule 3 can be efficiently
  • the position of the compression capsule 1 is adjusted to ensure that the compression capsule 1 can always be in close contact with the outer wall of the heart 2 after the heart is reconfigured.
  • Such a structure can better realize the pressure transmission between the compression capsule 1 and the regulation capsule 3.
  • the regulating capsule 3 and the pressing capsule 1 may not share the second membrane 52, but separate and set different membranes.
  • the pressing capsule 1 and the regulating capsule 3 may be integrally prepared from a whole film, or may be spliced from different films.
  • the present application does not limit the manufacturing methods of the pressing capsule 1 and the regulating capsule 3 .
  • the application does not limit the materials of the first film 51 , the second film 52 , the third film and the wrapping 53 .
  • the first film 51 can be selected from a flexible film that can directly contact the myocardium, such as made of relatively soft and fatigue-resistant silica gel, low-hardness TPU and other materials;
  • the second film 52 can be selected from high-hardness elastic plastics, such as PU, TPU , PVC and other materials.
  • the second film 52 is preferably configured as a multi-layer film structure including a flexible tensile reinforcement layer (such as nylon yarn, Pebax).
  • the third film or wrapping 53 can be selected from elastic plastic or metal materials with strong tensile rigidity and strength, such as PU, TPU, PVC and other materials, or nickel-titanium alloy, stainless steel or ultra-high molecular weight polyethylene. Material preparation.
  • the third film or wrapping 53 is preferably set to a matrix material that is PU, TPU or PVC, and includes a multi-layer film structure of reinforced nets such as nickel-titanium alloy, stainless steel or ultra-high molecular weight polyethylene with higher rigidity.
  • the outer wall of the regulating capsule 3 has greater rigidity, and the regulating capsule 3 can be limited.
  • the regulating bag 3 can only be expanded toward the direction of the pressing bag 1, but cannot be expanded toward the direction of the sheath 53, so that the regulating bag 3 can Press bladder 1 to apply pressure.
  • the application does not limit the structure of the wrapping 53, and the wrapping 53 can be set as a support net, a support sleeve or other types of support structures.
  • the number of regulating capsules 3 is multiple, and the plurality of regulating capsules 3 are all coated on the pressing capsule 1, and the plurality of regulating capsules 3 are used to be independently arranged in the corresponding left ventricle 211 and/or right ventricle 212. position, to adjust the position of different regions of the compression capsule 1, and realize the non-uniform adjustment of the compression capsule 1, so that the adjustment efficiency of the compression capsule 1 is higher, and the compression effect on the ventricle 21 is also better.
  • the reconfigured heart 2 may be separated from some areas of the compression capsule 1, and setting a plurality of independent adjustment capsules 3 can only adjust the pressure capsule. In 1, the area separated from the outer wall of the heart 2 is adjusted, instead of all the areas covered by the adjustment capsule 3 covering the compression capsule 1, the adjustment is accurate and the adjustment efficiency is high.
  • a plurality of independent regulating capsules 3 can be continuously arranged on the outer wall of the pressing capsule 1, that is, a plurality of independent regulating capsules 3 can be arranged continuously on the outer wall of the pressing capsule 1 without overlapping each other; At this time, a plurality of adjusting capsules 3 can be arranged on the outer wall of the pressing capsule 1 to adjust the position of any area of the pressing capsule 1 . In some other embodiments, a plurality of independent regulating capsules 3 can be arranged at intervals on the outer wall of the pressing capsule 1. At this time, the regulating capsules 3 can be arranged in some areas of the pressing capsule 1 as required, and can control the pressure of the partial areas of the pressing capsule 1. position to adjust.
  • the number of the regulating capsule 3 can also be one, and one regulating capsule 3 is coated on at least part of the outer wall of the pressing capsule 1, and the area covered with the regulating capsule 3 in the pressing capsule 1 can be simultaneously adjust.
  • the ventricular assist device further includes a delivery catheter, the delivery catheter has multiple delivery channels, and the multiple delivery channels communicate with a corresponding adjustment capsule 3, and different adjustment capsules 3 communicate with different delivery channels
  • the adjustment medium can be delivered to the corresponding adjustment capsule 3 through a plurality of delivery channels, so as to realize the partition adjustment of the pressing capsule 1 and improve the flexibility of adjustment.
  • the delivery catheter includes a first catheter 41, the distal end of the first catheter 41 is connected to the adjustment balloon 3, and the first catheter 41 can be configured as a single-lumen tube or a multi-lumen tube.
  • the first catheter 41 is a single-lumen tube, and the number of the single-lumen tubes is multiple, and multiple single-lumen tubes are connected to different regulating capsules 3 to control the pressures of different regulating capsules 3 respectively.
  • the regulating bladder 3 can apply pressure to different areas of the pressing bladder 1 respectively, so that the positions of different areas of the pressing bladder 1 can be flexibly adjusted.
  • the first catheter 41 is a multi-lumen tube and the number is one, and multiple lumens in one multi-lumen tube are connected to different adjustment capsules 3, so that different adjustment capsules 3 can be simultaneously Inject or extract the regulating medium, thereby improving the delivery efficiency of the delivery catheter.
  • the delivery catheter further includes a connection interface 42 , and the proximal end of the first catheter 41 is connected to the connection interface 42 .
  • the connection interface 42 can be directly connected to an external injection part, and the external injection part injects or extracts the regulating medium to the regulating capsule 3 through the first conduit 41 .
  • first catheter 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 .
  • connection interface 42 there are multiple first conduits 41, and multiple connection interfaces 42.
  • external injection components can be injected or injected into a corresponding regulating capsule 3 through different connection interfaces 42.
  • the regulating medium is extracted to control different regulating capsules 3 respectively; of course, in other embodiments, the number of the first conduit 41 can also be one, and the regulating medium can be delivered to the regulating capsule 3 through a connection interface 42 at this time.
  • the proximal end of each lumen of a multi-lumen tube is preferably connected to a connection interface 42 .
  • the number of regulating capsules 3 is multiple, and one end of the multi-lumen tube connected to the connection interface 42 may have one or more lumens and one or more connection interfaces 42, at this time
  • the external injection part can deliver the adjustment medium to different adjustment capsules 3 through one or more connection interfaces 42, so as to further improve the delivery efficiency of the adjustment medium.
  • connection interface 42 is provided with an openable and closable sealing portion (not shown), the closed sealing portion is used to block the first conduit 41, and the opened sealing portion is used for external
  • the injection part passes through, and the outer injection part is used for injecting or withdrawing the regulating medium into the regulating capsule 3 .
  • the sealing part is made of a septum, which can be pierced by an external injection part and can be automatically closed after piercing, so that the structure of the connection interface 42 is simple, easy to use and sealed. sexual effect is good.
  • the external injection part is usually an injection needle
  • the connection interface 42 is usually an injectable seat
  • the injection seat is usually implanted subcutaneously, and the injection needle can penetrate the septum on the injection seat and adjust Capsule 3 injects or withdraws conditioning media.
  • the ventricular assist device further includes a delivery device (not shown) and a control device 7, the delivery device and the control device 7 are connected in communication, and the delivery device is connected to the delivery catheter.
  • the delivery catheter also includes a second catheter 6 , and the distal end of the second catheter 6 is connected to the pressing balloon 1 .
  • control device 7 is used to control the delivery device to inject or extract the working medium into the pressing bag 1 through the second catheter 6 according to the received cardiac imaging data, so as to assist the contraction and expansion of the ventricle 21 .
  • control device 7 is used to control the delivery device to inject or extract an adjustment medium to the adjustment bladder 3 through the first catheter 41 according to the received cardiographic data, so as to adjust the pressure exerted by the adjustment bladder 3 on the pressing bladder 1 .
  • control device 7 also includes a pressure detection device, which can detect the pressure of the pressing bag 1 and the regulating bag 3 in real time, so as to make the pressing adjustment of the ventricle 21 more accurate and the assisting effect better.
  • a pressure detection device can detect the pressure of the pressing bag 1 and the regulating bag 3 in real time, so as to make the pressing adjustment of the ventricle 21 more accurate and the assisting effect better.
  • an electrode can be provided on at least one of the first film 51, the second film 52, the third film and the sheath 53, and the pressure detection device can obtain the adjustment capsule 3 and the compression capsule 1 according to the cardiac imaging data detected by the electrodes.
  • the pressure can be adjusted to adjust the pressure between the capsule 3, the compression capsule 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 the pressure detection device is not limited, such as including but not limited to a pressure sensor.
  • the second catheter 6 can pass through the chest wall. At this time, a part of the second catheter 6 is arranged inside the patient's body, and the other part is arranged outside the patient's body. In this way, the control device 7 can be arranged outside the patient's body, thereby It is convenient for the operator to obtain the cardiac imaging data of the patient.
  • control device 7 and the delivery device can be arranged separately. At this time, the delivery device can be placed inside or outside the patient's body and communicated with the control device 7 . In another embodiment, the delivery device can also be integrated into the control device 7 to simplify the structure of the ventricular assist device.
  • the delivery device includes a fluid pump, and further includes a valve.
  • the control device 7 can control the opening or closing of the valve according to the cardiac imaging data, and control the delivery state of the fluid pump, so that the delivery device injects or extracts the working medium into the pressing bag 1, so as to realize the pairing of the pressing bag 1 Aid in contraction or expansion of the ventricle 21 .
  • the control device 7 can control the delivery device to deliver the working medium to the compression bag 1 periodically or intermittently, so as to achieve the compression of the ventricle 21 .
  • the delivery period of the delivery device can be set according to the patient's cardiac imaging data, for example, when the cardiac imaging data reaches a peak, as shown in FIG. 3 , the control device 7 can control the delivery device to inject the working medium into the working capsule 11 , to assist the ventricle 21 to complete the contraction; when the cardiographic data reaches the trough, as shown in Figure 2, the control device 7 can control the delivery device to extract the working medium from the working bag 11 to assist the ventricle 21 to complete the expansion; so reciprocating, the working The capsule 11 can assist the ventricle 21 to achieve normal contraction and expansion.
  • the number and frequency of assisting the ventricle 21 of the ventricular assist device can be set according to needs, that is, the ventricular assist device can assist each time the ventricle 21 contracts and expands, and can also be completed in the ventricle 21. Assist only once or in small numbers during multiple contractions and dilations.
  • the pressing capsule 1 includes a working capsule 11 and a supporting capsule 12 that are independently arranged (that is, not communicated with each other); the working capsule 11 is used to assist the ventricle 21 to contract or expansion, the support capsule 12 is used to fix at least part of the outer wall of the heart 2, generally it is enough to fix the outer wall of the ventricle 21 that needs to be contracted or expanded, so as to prevent the heart 2 from twisting or shifting under the pressure of the working capsule 11, thereby ensuring The compression effect of the ventricle 21 .
  • the pressure inside the support capsule 12 remains constant all the time, while the working capsule 11 can adjust its internal pressure at any time according to the cardiographic data, so as to The ventricle 21 is compressed periodically.
  • the present application does not limit the number of working capsules 11 and supporting capsules 12 , the number of working capsules 11 and supporting capsules 12 may be one or more, and the numbers of working capsules 11 and supporting capsules 12 may be the same or different.
  • the present application does not specifically limit the relative positional relationship between the working capsule 11 and the supporting capsule 12 , and generally, the working capsule 11 and the supporting capsule 12 can be arranged alternately in the circumferential direction of the outer wall of the ventricle.
  • the present application does not limit the alternate arrangement of the working capsules 11 and the supporting capsules 12.
  • at least one working capsule 11 can be arranged between two adjacent supporting capsules 12, and at least one working capsule 11 can be arranged between adjacent two working capsules 11.
  • a support bladder 12 .
  • a plurality of working capsules 11 can be distributed in the corresponding areas of the left ventricle 211 and the right ventricle 212, so that the left ventricle 211 and the right ventricle 212 can be controlled by injecting or extracting working media into different working capsules 11.
  • the spaced arrangement of the support capsules 12 can form a plurality of fixed areas on the outer wall of the heart 2, so that the heart 2 can be further fixed firmly.
  • the number of the working bag 11 and the supporting bag 12 is 3, and the working bag 11, the supporting bag 12, the working bag 11, the supporting bag 12, the working bag 11 1.
  • the supporting capsules 12 are alternately arranged on the outer walls of the corresponding left ventricle 211 and right ventricle 212, that is, one supporting capsule 12 is arranged between every two adjacent working capsules 11, which can basically meet the treatment requirements.
  • two or more support capsules 12 may also be arranged between every two adjacent working capsules 11 .
  • control device 7 can control the states (mainly the pressure) of the multiple working capsules 11 respectively through the delivery device, and the states of the multiple working capsules 11 can be different or the same, so as to precisely control the pressure applied to the left ventricle 211 and the right ventricle 212. pressure.
  • the second catheter 6 can be a single-lumen tube or a multi-lumen tube.
  • the second catheter 6 is a single-lumen tube, the number of the second catheter 6 is multiple, and the plurality of second catheters 6 can be connected to a corresponding working capsule 11, and the delivery devices can be independently Inject or extract the working medium into each working capsule 11 in a timely manner, so as to realize the respective compression of different ventricles 21 .
  • the second catheter 6 is a multi-lumen tube, and the number of the second catheter 6 is one, and multiple lumens in one second catheter 6 can be connected to different working capsules 11, and at this time, the The device can deliver the working medium to a plurality of working capsules 11 through only one second conduit 6, so that the delivery efficiency of the working medium can be improved.
  • the control device 7 can obtain the patient's cardiac imaging data, and control the delivery device to periodically inject or extract the working medium into the working capsule 11, so as to The auxiliary ventricle 21 contracts or expands; when the ventricular assist device is implanted for a period of time, the patient will regularly undergo CT angiography, and the doctor will compare the CT angiography data of this time with the previous CT angiography data, if the patient's CT angiography If the size of the heart 2 changes, the doctor will inject or extract the adjustment medium into the adjustment capsule 3 according to the size data of the change of the heart 2. At this time, the pressure capsule 1 can move toward the outer wall of the heart driven by the adjustment capsule 3 until it is re- It is closely attached to the outer wall of the heart 2 .
  • control device 7 can be hardware that performs logical operations, such as a single-chip microcomputer, a microprocessor, a programmable logic controller (PLC, Programmable Logic Controller) or a field programmable logic gate array (FPGA). , Field-Programmable Gate Array), or software programs, functional modules, functions, object libraries (Object Libraries) or dynamic link libraries (Dynamic-Link Libraries) that realize the above functions based on hardware. It should be known how to realize the communication between the control device 7 and other devices.
  • PLC programmable logic controller
  • FPGA field programmable logic gate array
  • the ventricular assist device provided by the present invention can adjust the position of the compression capsule 1 after the heart 2 is remodeled by adjusting the capsule 3, so that the compression capsule 1 can be closely attached to the outer wall of the reconfigured heart 2, and After the heart is remodeled, the pressing bag 1 can always effectively press the ventricle 21, thereby ensuring the long-term therapeutic effect of the ventricular assist device.
  • the adjustment capsule 3 can adjust the position of the compression capsule 1, the compression capsule 1 of the same specification can cover and press the outer wall of the heart of different patients, thereby realizing the standardized and mass production of ventricular assist devices. In this way, the production cost of the ventricular assist device can be effectively reduced and the production efficiency can be improved.
  • the standardized production of compression capsule 1 has no customized production cycle, and can be implanted at any time when the patient needs it, which can effectively reduce the waiting time of the patient before surgery, avoid the deterioration of the patient's condition, and effectively reduce the disability of the patient and risk of death.

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Abstract

一种心室辅助装置，包括按压囊(1)、调节囊(3)和包套(53)，按压囊(1)用于包覆心脏(2)的至少部分外壁，以辅助心室(21)进行收缩或扩张，调节囊(3)包覆至少部分按压囊(1)，以调节按压囊(1)的位置；包套(53)包覆至少部分调节囊(3)，其中，按压囊(1)的内部用于存储工作介质，调节囊(3)的内部用于存储调节介质。心室辅助装置的按压囊(1)可对不同患者的心脏(2)进行包覆，且调节囊(3)可在心脏(2)发生重构后对按压囊(1)的位置进行调节，使得按压囊(1)能够与重构后心脏(2)的外壁重新贴靠，并使按压囊(1)能够始终对心室(21)进行有效按压，从而保证心室辅助装置的长期治疗效果。

Description

心室辅助装置 技术领域
本发明涉及医疗器械技术领域，特别涉及一种心室辅助装置。
背景技术
心室辅助装置是利用人工材料制成的机械装置，心室辅助装置可以暂时或永久替代心脏泵血功能，以减少心脏负荷，并能够辅助心脏实现血液循环，目前已成为治疗心力衰竭和延长寿命的重要医疗手段。心室辅助装置可分为血液直接接触式心室辅助装置和非血液直接接触式心室辅助装置。目前的血液直接接触式心室辅助装置通常采用搏动式薄膜泵和恒流泵(例如轴流泵、离心泵)对血流直接做功，从而提高血流的流速和压强，以实现对心室按压功能的辅助。但该种类型的心室辅助装置均有部分组件(如泵壳、叶轮、抽吸管路等)与人体血液直接接触，并对血液输出驱动力，如此将具有血液相容性(例如凝血和溶血)的风险；同时在该种类型的心室辅助装置植入后，患者还较易出现外周动脉血栓、内脏出血、甚至死亡等不良事件。
基于血液直接接触式心室辅助装置的上述问题，近年来，有多家公司及科研机构对非血液直接接触式心室辅助装置展开了研究。常见的非血液接触式心室辅助装置通常具有一个能够包覆于心脏外壁的包套，并在心脏外壁与包套之间设置按压囊。按压囊中充满压缩空气，按压囊与心脏外壁紧密贴合，在压缩空气的驱动下按压囊扩张或收缩，以实现按压囊对心室的按压。但是，一方面，由于包套的形状通常较为固定，在心室辅助装置植入人体后，患者的心脏将发生重构，即患者心脏的体积和形状将发生变化，此时形状相对固定的包套和按压囊无法与重构后的心脏外壁充分贴合，如此将影响对心室的按压效果，进而影响心室辅助装置的治疗效果。另一方面，所述包套的几何模型是由患者心脏的影像数据逆向重构而获得，由于每个患者的心脏形状各异，故每个患者根据心脏影像数据获得的包套尺寸也各不相同，包套的定制化制备方式使得包套生产效率较低且难以进行标准化和批量化的生产，生产成本较高；并且所述包套需在患者采集心脏影像数据后制备，患者在手术前 往往需要较长的等待时间，如此可提高患者疾病的治疗周期，增加患者的心理负担，还可能导致患者病情的恶化，甚至造成患者的致残或死亡。
因此，亟需一种可适用于不同患者，以及心脏发生重构后还能有效按压心脏的心室辅助装置。
发明内容
本发明的目的在于提供一种心室辅助装置，该心室辅助装置的按压囊可实现针对不同患者形状各异的心脏外壁进行包覆，调节囊可在心脏发生重构后对按压囊的位置进行调节，使得按压囊能够重新与重构后心脏的外壁紧密贴靠，使得按压囊能够始终对心室进行有效按压，进而保证心室辅助装置的长期治疗效果。
为实现上述目的，本发明提供一种心室辅助装置，包括按压囊、调节囊和包套；所述按压囊用于包覆心脏的至少部分外壁，以辅助心室进行收缩或扩张；所述调节囊包覆至少部分所述按压囊，以调节所述按压囊的位置，所述包套包覆至少部分所述调节囊；其中，所述按压囊的内部用于存储工作介质，所述调节囊的内部用于存储调节介质。
可选的，所述调节囊的数量为多个，多个所述调节囊均包覆在所述按压囊上并相互独立地设置，以调节所述按压囊不同区域的位置。
可选的，所述心室辅助装置还包括输送导管，所述输送导管具有多个输送通道，多个所述输送通道与对应的一个所述调节囊连通，且不同调节囊连通不同的输送通道。
可选的，所述输送导管包括第一导管，所述第一导管的远端连接所述调节囊；
所述第一导管为单腔管，所述单腔管的数量为多根，多根所述单腔管连接不同的调节囊，或者，所述第一导管为多腔管且数量为一根，一根所述多腔管中的多个腔道连接不同的调节囊。
可选的，所述输送导管还包括连接接口，所述第一导管的近端连接所述连接接口；
当所述第一导管为单腔管时，每根所述单腔管的近端连接一个所述连接 接口；
当所述第一导管为多腔管时，一根所述多腔管的每个腔道的近端连接一个所述连接接口。
可选的，所述连接接口上设置有可开闭的密封部；闭合后的所述密封部用于封堵所述第一导管；打开后的所述密封部用于供外部的注射部件通过，外部的所述注射部件用于向所述调节囊内注入或抽取所述调节介质。
可选的，所述密封部由隔膜制成，所述隔膜能够被外部的所述注射部件刺穿，并在刺穿后还能够自动闭合。
可选的，所述按压囊包括第一薄膜和第二薄膜，所述第一薄膜和所述第二薄膜之间形成封闭的第一空腔，所述第一空腔用于存储所述工作介质；所述调节囊包括所述第二薄膜和第三薄膜，所述第二薄膜和所述第三薄膜之间形成封闭的第二空腔，所述第二空腔用于存储所述调节介质。
可选的，所述心室辅助装置还包括输送导管、输送装置和控制装置，所述控制装置与所述输送装置通信连接，所述输送装置与所述输送导管连接；
所述输送导管包括第一导管和第二导管；所述第一导管的远端连接所述调节囊，近端连接所述输送装置；所述第二导管的远端连接所述按压囊，近端连接所述输送装置；
其中，所述控制装置用于根据所接收的心脏造影数据，控制所述输送装置通过所述第一导管向所述调节囊注入或抽取所述调节介质；和/或，所述控制装置用于根据所接收的心脏造影数据，控制所述输送装置通过所述第二导管向所述按压囊注入或抽取所述工作介质。
可选的，所述按压囊包括独立设置的工作囊和支撑囊；所述工作囊用于辅助所述心室进行收缩或扩张，所述支撑囊用于固定心脏的至少部分外壁。
可选的，所述工作囊和所述支撑囊的数量为多个，多个所述工作囊和多个所述支撑囊用于在心室外壁上间隔设置且互不重叠。
可选的，所述工作囊和所述支撑囊用于在心室外壁的周向上交替地设置。
本发明提供的心室辅助装置可通过调节囊在心脏发生重构后对按压囊的位置进行调节，使得按压囊能够与重构后的心脏外壁紧密贴靠，并且在心脏发生重构后，按压囊始终能够对心室进行有效按压，从而保证心室辅助装置 的长期治疗效果。此外，由于调节囊能够调节按压囊的位置，如此可使同一规格的按压囊可对不同患者的心脏外壁进行包覆和按压，进而可实现心室辅助装置的规格化和批量化生产，如此可有效降低心室辅助装置的生产成本，并提升生产效率。另外，规格化生产的按压囊无定制化的生产周期，并可在患者需要时随时进行植入，如此可有效减少患者手术前的等待时间，避免患者病情的恶化，并有效降低患者致残和致死的风险。
附图说明
图1为本发明一优选实施例中心室辅助装置的应用场景图；
图2为本发明一优选实施例中心脏处于舒张期时心脏、调节囊和按压囊的状态示意图，其中显示的是心室的截面图；
图3为本发明一优选实施例中心脏处于收缩期时心脏、调节囊和按压囊的状态示意图，其中显示的是心室的截面图。
图中：按压囊1；工作囊11；支撑囊12；心脏2；心室21；左心室211；右心室212；调节囊3；第一导管41；连接接口42；第一薄膜51；第二薄膜52；包套53；第二导管6；控制装置7。
具体实施方式
以下结合附图和具体实施例对本发明作进一步详细说明。根据下面说明，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
在本发明中，除非另有明确的规定和限定，术语“安装”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接， 或成一体；可以是机械连接，也可以是电连接或彼此可通讯；可以是直接相连，也可以通过中间媒介相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。本发明的描述中，“多个”的含义是至少两个，例如两个或三个或更多个等。本发明的描述中，“近端”通常是指靠近手术操作者的一端；“远端”是与“近端”相反的一端，通常是指远离手术操作者的一端，也即首先进入体内的一端。本发明的描述中，“心室外壁的周向”是指围绕左心室和右心室的方向。
下面结合附图和优选实施例对本发明作详细的说明。在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。
如图1～3所示，本发明一优选实施例提供一种心室辅助装置，其包括按压囊1、调节囊3和包套53，按压囊1用于包覆心脏2的至少部分外壁，以辅助心室21进行收缩或扩张。调节囊3包覆至少部分按压囊1，以调节按压囊1的位置，包套53包覆至少部分调节囊3。其中，按压囊1具有封闭的第一空腔，所述第一空腔用于存储工作介质；调节囊3具有封闭的第二空腔，所述第二空腔用于存储调节介质。通常的，按压囊1主要包覆心室21的心肌组织外壁(即心室外壁)，如此配置，可通过向按压囊1注入或抽取工作介质，对心室21进行辅助按压，以辅助心脏实现血液循环；同时在按压囊1背离心脏的外侧设置调节囊3，可通过向调节囊3注入或抽取调节介质来调节按压囊1的位置，即调节囊3可以挤压按压囊1，以使按压囊1在任何时候都能够与心脏2的外壁紧密贴靠。
更详细的，在现有技术中，心室辅助装置植入体内后，由于患者心脏的体积和形状将发生变化，此时形状相对固定的包套53和按压囊1无法与重构后的心脏外壁充分贴合。而在本发明中，将以上心室辅助装置植入体内后，若心脏的体积变小，可通过向调节囊3内注入调节介质，以使调节囊3的体积扩大，并推动按压囊1朝心室21的方向移动，以使按压囊1与心脏2的外壁重新紧密贴靠；若心脏的体积变大，则可通过抽取调节囊3内的调节介质，以使调节囊3的体积缩小，并使按压囊1能够朝远离心室21的方向移动，以减少按压囊1对心脏2外壁的挤压，并同时确保按压囊1与心脏2外壁的紧 密贴靠；如此配置，可确保按压囊1能够在心脏发生重构后始终对心室21进行有效按压，保证心室辅助装置的长期治疗效果。通过调节囊3的上述调节作用，同一规格的包套53和按压囊1能够对不同患者的心脏2进行包覆和按压，进而可实现心室辅助装置的规格化和批量化生产，如此可有效降低心室辅助装置的生产成本，提升生产效率。此外，规格化生产的包套53和按压囊1无定制化的生产周期，并可在患者需要时随时进行植入，从而可有效减少患者手术前的等待时间，避免患者病情的恶化，并有效降低患者致残和致死的风险。
此外，所述工作介质和所述调节介质主要采用流动性较好的气体或液体，如此可以更高效的调整按压囊1和调节囊3各区域的压力，以提高心室辅助装置的调节效率和心室按压效率。本申请对工作介质和调节介质的种类不作限定，所述气体包括但不限于氮气、氦气或压缩空气，所述液体包括但不限于纯水或生理盐水。另外，所述工作介质和所述调节介质的种类可相同或不相同。
进一步地，按压囊包括第一薄膜和第二薄膜，第一薄膜和第二薄膜之间形成封闭的第一空腔，第一空腔用于存储工作介质；调节囊包括第二薄膜和第三薄膜(附图中未示出)，第二薄膜和第三薄膜之间形成封闭的第二空腔，第二空腔用于存储调节介质。在本实施例中，按压囊1包括第一薄膜51和第二薄膜52，第一薄膜51和第二薄膜52之间形成第一空腔，此时第一薄膜51用于直接贴靠心脏2的外壁并构成按压囊1的内壁，第二薄膜52用于直接接触调节囊3并构成按压囊1的外壁。调节囊3包括第二薄膜52和包套53，第二薄膜52和包套53之间形成第二空腔，此时，第二薄膜52构成调节囊3的内壁，包套53构成调节囊3的外壁。在本实例中，优选包套53即为第三薄膜。当然在其他实施例中，包套53和第三薄膜可以是分开设置不同的薄膜。在本实施例中，优选调节囊3和按压囊1共用第二薄膜52，如此配置，调节囊3可将自身体积改变而产生的压力有效的传递至按压囊1，并使得调节囊3能够高效的对按压囊1的位置进行调整，从而在心脏重构后保证按压囊1能够始终与心脏2的外壁紧密贴靠，如此构造，可较好的实现按压囊1和调节囊3压力的传递。当然在其他实施例中，调节囊3和按压囊1也可不共用第 二薄膜52，而是分开设置不同的薄膜。
需理解的是，按压囊1和调节囊3可以是由整张薄膜一体制备而成，也可由不同的薄膜拼接而成。本申请对按压囊1和调节囊3的制作方式不限定。此外，本申请对第一薄膜51、第二薄膜52、第三薄膜和包套53的材料不作限定。例如第一薄膜51可选用能够直接接触心肌的柔性薄膜，例如采用较为柔软且可耐疲劳的硅胶、低硬度TPU等材料制备；第二薄膜52可选用高硬度的弹性塑料，例如采用PU、TPU、PVC等材料制备。第二薄膜52优选设置为包含柔性抗拉加强层(如尼龙丝、Pebax)的多层的膜结构。第三薄膜或包套53可选用具有较强的抗拉刚度和强度的弹性塑料或金属材料，例如采用PU、TPU、PVC等材料制备，或使用镍钛合金、不锈钢或超高分子量聚乙烯等材料制备。第三薄膜或包套53优选设置为基体材料为PU、TPU或PVC，并包含较高刚度的镍钛合金、不锈钢或超高分子量聚乙烯等加强网的多层的膜结构，如此设置，可使调节囊3的外壁具有较大的刚度，并能够限位调节囊3。由于调节囊3的内壁刚度较小，当向调节囊3中注入调节介质时，调节囊3仅能够朝按压囊1的方向膨胀，而不能朝包套53的方向膨胀，使得调节囊3能够对按压囊1施加压力。本申请对包套53的结构不作限定，包套53可设置为支撑网、支撑套筒或其他类型的支撑结构。
优选的，调节囊3的数量为多个，且多个调节囊3均包覆在按压囊1上，多个调节囊3用于独立地设置在对应于左心室211和/或右心室212的位置，以调节按压囊1不同区域的位置，并实现按压囊1的非均匀调节，如此可使按压囊1的调节效率更高，对心室21按压的效果也更好。具体的，在心室辅助装置植入后，由于患者的心脏会发生重构，重构后的心脏2可能会与按压囊1的部分区域分离，设置多个独立的调节囊3可仅对按压囊1中与心脏2外壁相分离的区域进行调节，而不必对调节囊3包覆按压囊1的所有区域均进行调节，调节精准且调节效率较高。
应理解，在一些实施例中，多个独立的调节囊3可连续的设置在按压囊1的外壁，即多个独立的调节囊3可在按压囊1的外壁上连续排列且互不重叠；此时可在按压囊1的外壁上设置多个调节囊3，以调节按压囊1任意区域的位置。在另一些实施例中，多个独立的调节囊3可在按压囊1的外壁上间隔设 置，此时调节囊3可根据需要设置在按压囊1的部分区域，并对按压囊1部分区域的位置进行调节。
在另一些实施例中，调节囊3的数量也可为一个，且一个调节囊3包覆在按压囊1的至少部分外壁上，并可对按压囊1中包覆调节囊3的区域同时进行调节。
在一优选实施例中，所述心室辅助装置还包括输送导管，所述输送导管具有多个输送通道，多个输送通道与对应的一个调节囊3连通，且不同调节囊3连通不同的输送通道，此时可通过多个输送通道向对应的一个调节囊3中输送调节介质，从而实现对按压囊1的分区调节，提升调节的灵活性。
参照图1和图2所示，所述输送导管包括第一导管41，第一导管41的远端连接调节囊3，第一导管41可设置为单腔管或多腔管。在一实施例中，第一导管41为单腔管，所述单腔管的数量为多根，多根单腔管连接不同的调节囊3，以分别控制不同调节囊3的压力，多个调节囊3可分别对按压囊1的不同区域施加压力，从而可灵活地调节按压囊1不同区域的位置。在另一实施例中，第一导管41为多腔管且数量为一根，一根所述多腔管中的多个腔道连接不同的调节囊3，如此可同时向不同的调节囊3内注入或抽取调节介质，从而提升输送导管的输送效率。
继续参阅图1，所述输送导管还包括连接接口42，第一导管41的近端连接所述连接接口42。较优的，连接接口42可直接连接外部的注射部件，外部的注射部件通过第一导管41向调节囊3注入或抽取调节介质。
当第一导管41为单腔管时，每根单腔管的近端优选连接一个连接接口42。在一实施例中，第一导管41的数量为多个，连接接口42的数量也为多个，此时外部的注射部件可通过不同的连接接口42分别向对应的一个调节囊3中注入或抽取调节介质，以分别控制不同的调节囊3；当然在其他实施例中，第一导管41的数量也可为一个，此时可通过一个连接接口42向调节囊3内输送调节介质。
当第一导管41为多腔管时，一根所述多腔管的每个腔道的近端优选连接一个连接接口42。在一优选实施例中，调节囊3的数量为多个，所述多腔管与连接接口42相连接的一端可具有一个或多个腔道，并具有一个或多个连接 接口42，此时外部注射部件可通过一个或多个连接接口42向不同的调节囊3中输送调节介质，以进一步提高调节介质的输送效率。
较优的，连接接口42上设置有可开闭的密封部(未图示)，闭合后的所述密封部用于封堵第一导管41，打开后的所述密封部用于供外部的注射部件通过，外部的注射部件用于向调节囊3内注入或抽取调节介质。在一示例中，所述密封部由隔膜制成，所述隔膜能够被外部的注射部件刺穿，并在刺穿后还能够自动闭合，如此可使连接接口42的结构简单，使用方便且密封性效果好。具体的，所述外部注射部件通常为注射针，连接接口42通常为可注射座，所述注射座通常在皮下植入，所述注射针能够穿透所述注射座上的隔膜，并向调节囊3注入或抽取调节介质。
在一优选实施例中，所述心室辅助装置还包括输送装置(未图示)和控制装置7，所述输送装置和控制装置7通信连接，所述输送装置与所述输送导管连接。所述输送导管还包括第二导管6，第二导管6的远端连接按压囊1。
作为一示例，控制装置7用于根据所接受的心脏造影数据，控制所述输送装置通过第二导管6向按压囊1注入或抽取工作介质，以辅助心室21的收缩和扩张。
作为一示例，控制装置7用于根据所接受的心脏造影数据，控制所述输送装置通过第一导管41向调节囊3注入或抽取调节介质，以调整调节囊3对按压囊1施加的压力。
可选的，控制装置7还包括压力检测装置，所述压力检测装置可实时检测按压囊1和调节囊3的压力，以使对心室21的按压调整更为精确，辅助效果更好。具体的，可在第一薄膜51、第二薄膜52、第三薄膜及包套53中的至少一个上设置电极，压力检测装置可根据电极检测到的心脏造影数据获取调节囊3和按压囊1的压力，从而可得到调节囊3、按压囊1和心室21外壁之间的按压程度，以使心室辅助装置能够更加精确和高效的对心室21进行辅助。所述压力检测装置的种类不限定，如包括但不限于压力传感器。
在一具体实施例中，第二导管6可穿过胸壁，此时第二导管6一部分设置在患者的体内，另一部分设置在患者的体外，如此可将控制装置7设置在患者的体外，从而可方便操作人员对患者心脏造影数据的获取。
在一实施例中，控制装置7和输送装置可分体设置，此时可将输送装置设置在患者的体内或体外，并与控制装置7通信连接。在另一实施例中，也可将输送装置集成设置在控制装置7内，以使心室辅助装置的结构简化。
在一具体实施例中，所述输送装置包括流体泵，进一步还可包括阀门。控制装置7可根据心脏造影数据控制所述阀门的开启或关闭，并控制所述流体泵的输送状态，以使所述输送装置向按压囊1内注入或抽取工作介质，从而实现按压囊1对心室21收缩或扩张的辅助。在一具体实施例中，控制装置7可控制输送装置向按压囊1周期性的输送工作介质或间断性的输送工作介质，以实现对心室21的按压。
更详细地，输送装置的输送周期可根据患者的心脏造影数据进行设置，例如当心脏造影数据达到波峰时，参照图3所示，控制装置7可控制输送装置将工作介质注入到工作囊11中，以辅助心室21完成收缩；当心脏造影数据达到波谷时，参照图2所示，控制装置7可控制输送装置将工作介质从工作囊11中抽出，以辅助心室21完成扩张；如此往复，工作囊11即可辅助心室21实现正常的收缩和扩张。应理解，所述心室辅助装置的对心室21的辅助次数和辅助频率可根据需要进行设置，即所述心室辅助装置可在心室21每次收缩和扩张时均进行辅助，也可在心室21完成多次收缩和扩张时仅进行一次或少量次数的辅助。
参照图1～图3所示，在一优选实施例中，按压囊1包括独立设置的(即相互不连通的)工作囊11和支撑囊12；所述工作囊11用于辅助心室21进行收缩或扩张，支撑囊12用于固定心脏2的至少部分外壁，一般固定需要收缩或扩张的心室21外壁即可，从而可避免心脏2在工作囊11的按压下发生扭动或移位，从而保证心室21的按压效果。还应理解，为了使支撑囊12能够有效的固定心脏2的外壁，实际使用时，支撑囊12内的压力始终保持不变，而工作囊11可随时根据心脏造影数据调整其内部的压力，以对心室21进行周期性的按压。
本申请对工作囊11和支撑囊12的数量不限定，工作囊11和支撑囊12的数量可以是一个或多个，且工作囊11和支撑囊12的数量可以相同或不相同。优选的，工作囊11和支撑囊12的数量为多个，多个工作囊11和多个支 撑囊12用于在心室外壁上间隔设置且互不重叠。本申请对工作囊11和支撑囊12之间的相对位置关系不作特别的限定，一般情况下，工作囊11和支撑囊12可用于在心室外壁的周向上交替地设置。
本申请对工作囊11和支撑囊12交替布置的方式亦不作限定，如相邻两个支撑囊12之间可设置至少一个工作囊11，又如相邻两个工作囊11之间可设置至少一个支撑囊12。如此设置，一方面可使多个工作囊11分布在左心室211和右心室212的对应区域，从而可通过向不同的工作囊11中注入或抽取工作介质，实现对左心室211和右心室212的分别按压；另一方面，支撑囊12的间隔设置可在心脏2的外壁上形成多个固定区域，从而可进一步使心脏2固定牢固。
参照图2和图3所示，在本实施例中，工作囊11和支撑囊12的数量均为3个，且以工作囊11、支撑囊12、工作囊11、支撑囊12、工作囊11、支撑囊12的交替方式布置在对应左心室211和右心室212的外壁上，也即，每相邻两个工作囊11之间均设置一个支撑囊12，如此设置基本上能够满足治疗需求。当然在其他实施例中，每相邻两个工作囊11之间还可设置2个或更多的支撑囊12。
进一步地，控制装置7可通过输送装置分别控制多个工作囊11的状态(主要是压力)，多个工作囊11的状态可以不同或相同，以精确控制对左心室211和右心室212所施加的压力。
当工作囊11的数量为多个时，所述第二导管6可为单腔管或多腔管。在一实施例中，第二导管6为单腔管，第二导管6的数量为多根，多根第二导管6可分别与对应的一个工作囊11相连接，此时输送装置能够分别独立地向每个工作囊11中注入或抽取工作介质，以实现对不同心室21的分别按压。在另一实施例中，第二导管6为多腔管，且第二导管6的数量为一根，一根第二导管6中的多个腔体可连接不同的工作囊11，此时输送装置能够仅通过一根第二导管6即可向多个工作囊11中输送工作介质，如此可提高工作介质的输送效率。
接下去结合优选实施例对心室辅助装置的工作过程做进一步说明。
总体上，参照图1～图3所示，在心室辅助装置植入体内后，控制装置7 可获取患者的心脏造影数据，并控制输送装置周期性的向工作囊11注入或抽取工作介质，以辅助心室21进行收缩或扩张；当心室辅助装置植入一段时间后，患者会定期进行CT造影，医生会将该次的CT造影数据与上一次的CT造影数据进行比较，若患者该次CT造影显示心脏2的尺寸发生变化，医生将根据心脏2变化的尺寸数据向调节囊3中注入或抽取调节介质，此时按压囊1可在调节囊3的驱动下朝心脏外壁的方向移动，直至重新与心脏2的外壁紧密贴靠。
本申请对控制装置7的种类没有特别的限制，可以是执行逻辑运算的硬件，例如，单片机、微处理器、可编程逻辑控制器(PLC，Programmable Logic Controller)或者现场可编程逻辑门阵列(FPGA，Field-Programmable Gate Array)，或者是在硬件基础上的实现上述功能的软件程序、功能模块、函数、目标库(Object Libraries)或动态链接库(Dynamic-Link Libraries)。应当知晓如何具体实现控制装置7与其他设备间的通信。
综上，本发明提供的心室辅助装置可通过调节囊3在心脏2发生重构后对按压囊1的位置进行调节，使得按压囊1能够与重构后的心脏2外壁紧密贴靠，并且在心脏发生重构后，按压囊1始终能够对心室21进行有效按压，从而保证心室辅助装置的长期治疗效果。此外，由于调节囊3能够调节按压囊1的位置，如此可使同一规格的按压囊1可对不同患者的心脏外壁进行包覆和按压，进而可实现心室辅助装置的规格化和批量化生产，如此可有效降低心室辅助装置的生产成本，并提升生产效率。另外，规格化生产的按压囊1无定制化的生产周期，并可在患者需要时随时进行植入，如此可有效减少患者手术前的等待时间，避免患者病情的恶化，并有效降低患者致残和致死的风险。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明的保护范围。

Claims (12)

  1. 一种心室辅助装置，其特征在于，包括按压囊、调节囊和包套；所述按压囊用于包覆心脏的至少部分外壁，以辅助心室进行收缩或扩张；所述调节囊包覆至少部分所述按压囊，以调节所述按压囊的位置，所述包套包覆至少部分所述调节囊；
    其中，所述按压囊的内部用于存储工作介质，所述调节囊的内部用于存储调节介质。
  2. 如权利要求1所述的心室辅助装置，其特征在于，所述调节囊的数量为多个，多个所述调节囊均包覆在所述按压囊上并相互独立地设置，以调节所述按压囊不同区域的位置。
  3. 如权利要求2所述的心室辅助装置，其特征在于，还包括输送导管，所述输送导管具有多个输送通道，多个所述输送通道与对应的一个所述调节囊连通，且不同调节囊连通不同的输送通道。
  4. 如权利要求3所述的心室辅助装置，其特征在于，所述输送导管包括第一导管，所述第一导管的远端连接所述调节囊；
    所述第一导管为单腔管，所述单腔管的数量为多根，多根所述单腔管连接不同的调节囊，或者，所述第一导管为多腔管且数量为一根，一根所述多腔管中的多个腔道连接不同的调节囊。
  5. 如权利要求4所述的心室辅助装置，其特征在于，所述输送导管还包括连接接口，所述第一导管的近端连接所述连接接口；
    当所述第一导管为单腔管时，每根所述单腔管的近端连接一个所述连接接口；
    当所述第一导管为多腔管时，一根所述多腔管的每个腔道的近端连接一个所述连接接口。
  6. 如权利要求5所述的心室辅助装置，其特征在于，所述连接接口上设置有可开闭的密封部；闭合后的所述密封部用于封堵所述第一导管；打开后的所述密封部用于供外部的注射部件通过，外部的所述注射部件用于向所述调节囊内注入或抽取所述调节介质。
  7. 如权利要求6所述的心室辅助装置，其特征在于，所述密封部由隔膜制成，所述隔膜能够被外部的所述注射部件刺穿，并在刺穿后还能够自动闭合。
  8. 如权利要求1所述的心室辅助装置，其特征在于，所述按压囊包括第一薄膜和第二薄膜，所述第一薄膜和所述第二薄膜之间形成封闭的第一空腔，所述第一空腔用于存储所述工作介质；所述调节囊包括所述第二薄膜和第三薄膜，所述第二薄膜和所述第三薄膜之间形成封闭的第二空腔，所述第二空腔用于存储所述调节介质。
  9. 如权利要求1所述的心室辅助装置，其特征在于，还包括输送导管、输送装置和控制装置，所述控制装置与所述输送装置通信连接，所述输送装置与所述输送导管连接；
    所述输送导管包括第一导管和第二导管；所述第一导管的远端连接所述调节囊，近端连接所述输送装置；所述第二导管的远端连接所述按压囊，近端连接所述输送装置；
    其中，所述控制装置用于根据所接收的心脏造影数据，控制所述输送装置通过所述第一导管向所述调节囊注入或抽取所述调节介质；和/或，所述控制装置用于根据所接收的心脏造影数据，控制所述输送装置通过所述第二导管向所述按压囊注入或抽取所述工作介质。
  10. 如权利要求1所述的心室辅助装置，其特征在于，所述按压囊包括独立设置的工作囊和支撑囊；所述工作囊用于辅助所述心室进行收缩或扩张，所述支撑囊用于固定心脏的至少部分外壁。
  11. 如权利要求10所述的心室辅助装置，其特征在于，所述工作囊和所述支撑囊的数量为多个，多个所述工作囊和多个所述支撑囊用于在心室外壁上间隔设置且互不重叠。
  12. 如权利要求11所述的心室辅助装置，其特征在于，所述工作囊和所述支撑囊用于在心室外壁的周向上交替地设置。
PCT/CN2022/129250 2021-11-29 2022-11-02 心室辅助装置 WO2023093478A1 (zh)

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Citations (7)

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US4536893A (en) * 1982-03-03 1985-08-27 Roberto Parravicini Implant device for substaining the activity of the myocardium
US4690134A (en) * 1985-07-01 1987-09-01 Snyders Robert V Ventricular assist device
CN87103753A (zh) * 1986-05-22 1987-12-09 阿斯特拉-技术公司 心脏助动器
US5131905A (en) * 1990-07-16 1992-07-21 Grooters Ronald K External cardiac assist device
US20170007404A1 (en) * 2013-01-08 2017-01-12 AdjuCor GmbH Implanting cardiac devices
CN206761975U (zh) * 2016-12-02 2017-12-19 卫洪超 人工心脏
CN110478546A (zh) * 2019-09-12 2019-11-22 首都医科大学附属北京安贞医院 一种心脏辅助器械

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4536893A (en) * 1982-03-03 1985-08-27 Roberto Parravicini Implant device for substaining the activity of the myocardium
US4690134A (en) * 1985-07-01 1987-09-01 Snyders Robert V Ventricular assist device
CN87103753A (zh) * 1986-05-22 1987-12-09 阿斯特拉-技术公司 心脏助动器
US5131905A (en) * 1990-07-16 1992-07-21 Grooters Ronald K External cardiac assist device
US20170007404A1 (en) * 2013-01-08 2017-01-12 AdjuCor GmbH Implanting cardiac devices
CN206761975U (zh) * 2016-12-02 2017-12-19 卫洪超 人工心脏
CN110478546A (zh) * 2019-09-12 2019-11-22 首都医科大学附属北京安贞医院 一种心脏辅助器械

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