CN115430036A - Ventricular assist device with diastolic function - Google Patents
Ventricular assist device with diastolic function Download PDFInfo
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- CN115430036A CN115430036A CN202110628377.1A CN202110628377A CN115430036A CN 115430036 A CN115430036 A CN 115430036A CN 202110628377 A CN202110628377 A CN 202110628377A CN 115430036 A CN115430036 A CN 115430036A
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- heart
- assist device
- ventricular assist
- flexible
- air bag
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- 230000002861 ventricular Effects 0.000 title claims abstract description 44
- 230000003205 diastolic effect Effects 0.000 title claims abstract description 19
- 238000004146 energy storage Methods 0.000 claims abstract description 15
- 230000006870 function Effects 0.000 claims abstract description 15
- 239000012528 membrane Substances 0.000 claims abstract description 11
- 229920000642 polymer Polymers 0.000 claims abstract description 4
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims abstract description 4
- 230000000747 cardiac effect Effects 0.000 claims description 7
- 239000012530 fluid Substances 0.000 claims description 4
- 239000003519 biomedical and dental material Substances 0.000 claims description 3
- 230000001737 promoting effect Effects 0.000 claims description 3
- 239000008280 blood Substances 0.000 description 10
- 210000004369 blood Anatomy 0.000 description 10
- 210000004379 membrane Anatomy 0.000 description 7
- 206010019280 Heart failures Diseases 0.000 description 4
- 230000008602 contraction Effects 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 206010052337 Diastolic dysfunction Diseases 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 210000000038 chest Anatomy 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000010146 3D printing Methods 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- 208000008253 Systolic Heart Failure Diseases 0.000 description 1
- 206010071436 Systolic dysfunction Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000003510 anti-fibrotic effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
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- 229940079593 drug Drugs 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
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- 238000003384 imaging method Methods 0.000 description 1
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- 230000006386 memory function Effects 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 210000000779 thoracic wall Anatomy 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
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Abstract
The invention discloses a ventricular assist device with a diastolic function, which comprises a flexible air bag attached to a heart, wherein the top of the flexible air bag is provided with an opening, and a pneumatic lock is arranged at the top of the flexible air bag; the flexible air bag is formed by two layers of biocompatible films, the biocompatible films extend upwards for a section to form the pneumatic lock which is in contact with the heart, and a locking structure is formed between the pneumatic lock and the heart, so that free air does not exist between the flexible air bag and the heart; one or more gas chambers are formed between the inner film and the outer film below the pneumatic lock, and the gas inlet and the gas outlet are respectively connected with each gas chamber; the ventricular assist device has an elastic energy storage element, which is a frame made of a shape memory alloy or a polymer, disposed on the outer membrane of the flexible balloon. The flexible balloon of the device inflates during systole to create a positive pressure and deflates during diastole without reversing or significantly disrupting the curvature of the heart, thereby assisting diastole.
Description
Technical Field
The invention relates to a ventricular assist device with a diastolic function, and belongs to the technical field of medical instruments.
Background
Heart failure is a major public health problem in developed and developing countries. There are two main forms of heart failure: systolic insufficiency and diastolic insufficiency. In systolic dysfunction, the heart contracts less strongly and is unable to pump enough blood as it normally would. In the case of diastolic dysfunction, the heart becomes stiff and fails to relax normally after contraction, and the ability of the heart to become congested is reduced and congested. Although systolic heart failure is more widely known, heart failure caused by diastolic dysfunction also increases morbidity and mortality from heart disease.
Since heart transplantation, while effective, is short-lived, it is thought to use artificial hearts or mechanical aids to sustain the life of a patient with heart failure. The ventricular assist devices can be classified into blood-contact type and non-blood-contact type according to the working form. Blood contact is mostly the pump, because blood and equipment direct contact cause the destruction to blood, can cause hemolysis and thrombus, simultaneously, if the flow of pump is too fast, can cause the ventricle suction phenomenon, threatens patient's life safety. And requires open chest surgery as well as surgery on the heart. The non-blood contact principle is that the heart is directly wrapped by the equipment, then the heart is controlled to contract synchronously with the natural heart to improve the heart function, the blood pumping volume is increased, the heart cannot be directly contacted with blood, but the traditional non-blood contact device can cause the heart to have reverse curvature due to extrusion.
Figures 1A-1C show the normal, zero and inverted curvature of the radial plane (long axis) of the heart from apex to base. Fig. 1A shows a normal or positive curvature of the interior of the chamber, with 1B being zero curvature and 1C being a negative or negative curvature.
The reverse curvature can greatly increase the ejection rate of blood. However, the curvature of the ventricles of a normal heart does not exhibit negative curvature. Conventional direct heart contact devices focus on improving contractility without concern for diastolic function, which can reverse the curvature of the heart. Furthermore, none of the conventional devices are implanted in a minimally invasive manner, requiring open chest surgery, and most conventional devices require suturing the device to the heart or pericardium.
Disclosure of Invention
The invention aims to provide a ventricular assist device with a diastolic function, which focuses on enhancing the diastolic capacity of an injured or diseased heart and has a function of assisting the diastole.
In order to realize the purpose, the invention adopts the following technical scheme:
a ventricular assist device with diastolic function, the device includes a flexible air bag attached to the heart, the flexible air bag being open at the top and having a pneumatic lock at the top;
the flexible air bag is formed by two layers of biocompatible films, the biocompatible films extend upwards for a section to form the pneumatic lock which is in contact with the heart, and a locking structure is formed between the pneumatic lock and the heart, so that free air does not exist between the flexible air bag and the heart;
one or more gas chambers are formed between the inner film and the outer film below the pneumatic lock, and a gas inlet and a gas outlet are respectively connected with each gas chamber;
the ventricular assist device is provided with an elastic energy storage element arranged on the outer membrane of the flexible air bag, and the elastic energy storage element is a frame made of shape memory alloy or polymer; when the cardiac pressure is lower than the end diastole pressure, the elastic energy storage element is used for generating negative pressure for promoting ventricular filling, and when the cardiac pressure exceeds the end diastole volume, the elastic energy storage element plays a role in limiting filling.
The inner membrane of the flexible bladder has folds and the gas chambers expand largely inwardly into contact with the epicardium of the heart when inflated.
The gas chamber is a chamber which is longitudinally guided during inflation and can be folded during deflation.
The top opening of the flexible air bag is small, and the pneumatic lock forms a locking structure in a mode of clamping the heart or wrapping the heart.
The ventricular assist device has an access port at the bottom for aspirating fluids that may be present between the heart and the device.
The outside of the ventricular assist device is covered with a membrane made of biomedical material.
The invention has the beneficial effects that:
the flexible bladder of the ventricular assist device of the present invention inflates and creates a positive pressure during systole and deflates during diastole without reversing or significantly disrupting the curvature of the heart, thereby assisting diastole.
The ventricular assist device of the present invention can be implanted with rapid minimally invasive procedures and does not require sutures or direct attachment to the heart, but rather is attached to the heart by pneumatic locking with minimal damage to the heart.
Drawings
Figures 1A-1C show the normal, zero and inverted curvature of the radial plane (long axis) of the heart from apex to base.
FIG. 2 is a schematic front cross-sectional view of a ventricular assist device in accordance with an embodiment of the invention in its deflated state for assisting in diastole after it has been installed on the heart.
Fig. 3 is a schematic front cross-sectional view of a ventricular assist device in accordance with an embodiment of the invention in an inflated state to assist contraction after the device has been attached to the heart.
FIG. 4 is a simplified elevational cross-sectional view of another embodiment of a ventricular assist device in accordance with the present invention as it is mounted on the heart in a deflated state to assist in diastole.
Fig. 5 is a schematic front cross-sectional view of another embodiment of a ventricular assist device of the present invention in an inflated state to assist contraction after attachment to the heart.
Fig. 6 is a top view of a heart assist device of the present invention.
Fig. 7 is a front view of a heart assist device of the present invention.
FIG. 8 is a schematic view of the attachment of the heart assist device of the present invention to an extracorporeal airway assembly.
Detailed Description
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
The ventricular assist device of the present invention has a function of assisting diastole. As an embodiment of the invention, as shown in fig. 2 and 3, the device comprises a flexible air bag 1 attached to the heart, the flexible air bag 1 being open at the top and having a pneumatic lock 2 at the top position; the flexible balloon is formed by two layers of biocompatible films (including an inner film 3 and an outer film 4) which extend upwards for a part to form the pneumatic lock 2 contacting with the heart, and a locking structure is formed between the pneumatic lock 2 and the heart, so that free air does not exist between the flexible balloon and the heart. As shown in fig. 3, one or more gas chambers 5 are formed between the inner film and the outer film below the pneumatic lock 2, and a gas inlet and a gas outlet (not shown) are respectively connected to each gas chamber 5; the ventricular assist device has an elastic energy storage element 6 disposed on the outer membrane of the flexible balloon, which is a frame made of shape memory alloy or polymer; when the cardiac pressure is lower than the end diastole pressure, the elastic energy storage element is utilized to generate negative pressure for promoting the filling of the ventricles, and when the cardiac pressure exceeds the end diastole volume, the elastic energy storage element plays a role in limiting the filling.
In the ventricular assist device, the opening at the top of the flexible air bag is small, the pneumatic lock forms a locking structure in a mode of clamping the heart or wrapping the heart, and the sealing performance is good. As shown in figures 2 to 5, the opening of the flexible air bag 1 is smaller and smaller as the flexible air bag is upwards, which is beneficial to completely fit the heart, a circle of pneumatic lock is extended from the top of the air bag, and the shape and the size of the pneumatic lock can be specially made according to the heart size of different patients, so that the aim of completely fitting the heart can be achieved. The purpose of the pneumatic lock is to fully engage the heart to form an internal closure, i.e., no free air, which could result in air leakage and failure to form a closure if the pneumatic lock were not engaged with the heart.
Due to the pneumatic lock, there is no free air in the space between the flexible bladder and the heart during use, so if the heart becomes smaller (due to blood blow out) the flexible bladder is pulled inwards. Likewise, when the flexible bladder expands outwardly, it applies traction to the heart like a suction cup. If there is free (normally none) air in the chest cavity, suction traction will draw air between the flexible bladder and the heart. However, due to the pneumatic lock, there is no free air between the flexible bladder and the heart, and the attractive pulling force is directed to the heart surface. Because the elastic energy storage element has a memory function, when the cardiac pressure exceeds the volume of the end diastole, the elastic energy storage element can provide a pressure limit diastole; when the heart pressure is lower than the end diastole volume, because free air does not exist, the pneumatic locking can give a dilating force to the heart to assist the diastole of the heart.
The ventricular assist device of the present invention selectively compresses the heart during systole and during diastole, gas exits the gas chamber through the gas outlet to pull open the biocompatible inner membrane of the pneumatic lock and pull open the heart to selectively assist in filling the heart. The ventricular assist device of the present invention can apply uneven pressure or uniform pressure to the surface of the heart to alter the end systolic structure of the heart, the end diastolic structure of the heart, or both. The ventricular assist device can uniformly or non-uniformly enhance the diastolic function of the heart by uniformly or non-uniformly inflating and deflating and performing different diastolic assist on different ventricles by using the pneumatic lock and the elastic characteristics thereof according to the pathological degree and diastolic requirements of each ventricle. For example, different gas chambers are inflated and deflated through independent inflation ports at the bottom, the inflation ports of each chamber are integrated on one pipe and connected with the bottom, and the time and the flow rate of the inflation and deflation are controlled by feeding back to a set program according to specific requirements, so that uneven and asynchronous auxiliary relaxation is realized. During end systole and early diastole, the ventricular assist device acts like a loaded spring to apply negative pressure to the epicardial surface to assist with ventricular filling.
In another embodiment of the invention, as shown in figures 4 and 5, the inner membrane of the flexible bladder is further pleated such that the gas chamber expands largely inwardly into contact with the epicardium of the heart when inflated.
In the ventricular assist device, the gas chamber of the flexible air bag is a chamber which is longitudinally guided during inflation, and can be folded during deflation, so that rapid minimally invasive implantation can be realized. The present invention does not stitch to the heart and there is minimal damage to the heart because the heart is naturally aspirated into the flexible bladder. In particular, the curvature of the flexible bladder needs to be reversed when the heart leaves the ventricular assist device (i.e. is squeezed out of the flexible bladder), but its stiffness (when pressurized) is able to resist the curvature reversal due to the provision of the elastic energy storage element.
As shown in fig. 6 and 7, the ventricular assist device has an access port 7 at the bottom for aspirating fluids that may be present between the heart and the device. Biocompatible lubricants, anticoagulants, antifibrotic agents, drugs or antibiotic agents, etc. may be injected between the heart and the flexible balloon, and the access port at the bottom of the device may be useful for aspirating fluids that may accumulate between the heart and the device.
The flexible bladder of the ventricular assist device of the present invention has two layers of biocompatible membranes separated by one or more gas-filled bladders that prevent adhesion between the epicardial surface of the heart and the chest wall. In addition, to facilitate removal of the ventricular assist device, the exterior of the device may be covered with a film to slow down fibrous adhesions. The film is made of a biomedical material. The ventricular assist device of the present invention is fabricated from a suitable, biocompatible, biostable, implantable material that minimizes the incidence of infection associated with implantation of medical devices.
In manufacturing the ventricular assist device of the present invention, it is preferred to fabricate the balloon using 3D printing techniques, obtain the patient's specific heart contours from imaging techniques or other techniques, print out the balloon that fits the patient best so that there is a good fit between the balloon and the heart and no free air, and seal the top around the heart.
The ventricular assist device of the present invention is connected to an external air circuit assembly during actual use. As shown in fig. 8, the air pump inflates the flexible air bag of the ventricle assisting device, the pressure sensor monitors the pressure in the flexible air bag and feeds the pressure back to the control device, and the control device controls the inflation and deflation operations, in particular, the control valve is operated.
Claims (6)
1. A ventricular assist device with diastolic function, the device comprising a flexible balloon attached to the heart, the flexible balloon being open at the top and having a pneumatic lock at the top;
the flexible air bag is formed by two layers of biocompatible films, the biocompatible films extend upwards for a section to form the pneumatic lock which is in contact with the heart, and a locking structure is formed between the pneumatic lock and the heart, so that free air does not exist between the flexible air bag and the heart;
one or more gas chambers are formed between the inner film and the outer film below the pneumatic lock, and a gas inlet and a gas outlet are respectively connected with each gas chamber;
the ventricular assist device is provided with an elastic energy storage element arranged on the outer membrane of the flexible air bag, and the elastic energy storage element is a frame made of shape memory alloy or polymer; when the cardiac pressure is lower than the end diastole pressure, the elastic energy storage element is used for generating negative pressure for promoting ventricular filling, and when the cardiac pressure exceeds the end diastole volume, the elastic energy storage element plays a role in limiting filling.
2. A ventricular assist device having diastolic function according to claim 1, wherein the inner membrane of the flexible bladder has folds, and the gas chamber expands largely inwardly when inflated, into contact with the epicardium of the heart.
3. A ventricular assist device with diastolic function according to claim 1 or 2, wherein the gas chambers are longitudinally oriented chambers when inflated and collapsible when deflated.
4. A ventricular assist device with diastolic function according to claim 1 or 2, wherein the flexible bladder has a small top opening and the pneumatic lock forms a locking structure in a manner to clamp or wrap around the heart.
5. A ventricular assist device with diastolic function according to claim 1 or 2, wherein the ventricular assist device has a passage opening at the bottom for aspirating fluids that may be present between the heart and the device.
6. A ventricular assist device with diastolic function according to claim 1 or 2, wherein the outside of the ventricular assist device is covered with a membrane made of biomedical material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110628377.1A CN115430036A (en) | 2021-06-04 | 2021-06-04 | Ventricular assist device with diastolic function |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110628377.1A CN115430036A (en) | 2021-06-04 | 2021-06-04 | Ventricular assist device with diastolic function |
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| Publication Number | Publication Date |
|---|---|
| CN115430036A true CN115430036A (en) | 2022-12-06 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110628377.1A Pending CN115430036A (en) | 2021-06-04 | 2021-06-04 | Ventricular assist device with diastolic function |
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| CN (1) | CN115430036A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080021260A1 (en) * | 2005-04-06 | 2008-01-24 | The Texas A&M University System | Device for the Modulation of Cardiac End Diastolic Volume |
| US20110021864A1 (en) * | 2009-07-22 | 2011-01-27 | The Texas A&M University System | Biphasic and Dynamic Adjustable Support Devices and Methods with Assist and Recoil Capabilities for Treatment of Cardiac Pathologies |
| CN212383079U (en) * | 2020-07-16 | 2021-01-22 | 中国医学科学院阜外医院 | External pressing type heart auxiliary device for ventricles |
| CN217091800U (en) * | 2021-06-04 | 2022-08-02 | 中国医学科学院阜外医院 | Ventricular assist device with diastole function |
-
2021
- 2021-06-04 CN CN202110628377.1A patent/CN115430036A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080021260A1 (en) * | 2005-04-06 | 2008-01-24 | The Texas A&M University System | Device for the Modulation of Cardiac End Diastolic Volume |
| US20110021864A1 (en) * | 2009-07-22 | 2011-01-27 | The Texas A&M University System | Biphasic and Dynamic Adjustable Support Devices and Methods with Assist and Recoil Capabilities for Treatment of Cardiac Pathologies |
| CN212383079U (en) * | 2020-07-16 | 2021-01-22 | 中国医学科学院阜外医院 | External pressing type heart auxiliary device for ventricles |
| CN217091800U (en) * | 2021-06-04 | 2022-08-02 | 中国医学科学院阜外医院 | Ventricular assist device with diastole function |
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