CN111110938A - Ventricular assist device and using method thereof - Google Patents
Ventricular assist device and using method thereof Download PDFInfo
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- CN111110938A CN111110938A CN202010036140.XA CN202010036140A CN111110938A CN 111110938 A CN111110938 A CN 111110938A CN 202010036140 A CN202010036140 A CN 202010036140A CN 111110938 A CN111110938 A CN 111110938A
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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
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a ventricular assist device and a using method thereof, wherein the ventricular assist device comprises a bracket, a connecting wire and an anchoring structure; the support comprises a plurality of elastic support arms and an annular support, and the rear ends of the elastic support arms are connected with the annular edge of the annular support to form a claw-shaped support structure matched with the ventricular structure and used for radially supporting the inner wall of the ventricle; the anchoring structure is anchored in the ventricle, the annular support is connected with the anchoring structure through a connecting line to fix the support in the ventricle, the outer side of the elastic support arm is in contact with the inner wall of the ventricle, the elastic support arm is stressed and compressed when the ventricle contracts, and the elastic support arm is restored and expanded when the ventricle relaxes. The ventricular assist device can be compressed when the ventricles contract, stores energy, generates radial supporting force, and assists the diastole of the ventricles by utilizing the radial supporting force when the ventricles relax, so that the cardiac function is improved, the structure is simple, and the compatibility is high.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a ventricular assist device and a using method thereof.
Background
The importance of diastolic dysfunction in congestive heart failure has become increasingly important in recent years. It may occur simultaneously with the systolic dysfunction or may be present alone. Diastolic heart failure occurs because of impaired ability of the diastolic ventricles to actively relax and reduced ventricular compliance such that ventricular filling is impaired during diastole, the ventricular pressure-volume curve shifts to the upper left, and thus stroke volume decreases, and left ventricular end-diastolic pressure increases, indicating a normal ejection fraction of systolic function.
① left ventricular relaxation is damaged, particularly, when myocardial ischemia occurs, the capability of myocardial sarcoplasmic reticulum to take Ca2+ is weakened, the level of free Ca2+ in myocardial cells is slowly reduced to cause active relaxation damage, ② myocardial hypertrophy and myocardial stiffness are increased (with myocardial fibrosis), the diastolic myocardial expansion capability is weakened (compliance is reduced), and the simple diastolic heart failure is commonly found in the patients with obvious myocardial hypertrophy, normal heart cavity size and fast heart rate, such as hypertensive heart disease in the centripetal hypertrophy stage, aortic stenosis, hypertrophic cardiomyopathy, ischemic cardiomyopathy and the like.
Left ventricular centripetal remodeling during diastolic heart failure is characterized by "luminal hypertension". By "elevated pressure" is meant an increase in diastolic phase, especially the left ventricular end-diastolic pressure, which in turn causes an increase in left atrial and pulmonary venous pressure, resulting in pulmonary stasis, with the same various clinical manifestations of "congestive heart failure syndrome" as systolic heart failure. When the hemodynamic disturbance occurs rapidly and the pressure of the pulmonary blood vessels is higher than the osmotic pressure of the plasma, the fluid in the blood vessels will extravasate into the human alveoli and acute pulmonary edema will occur. Clinical data indicate that about 25% of acute left heart failure is caused by diastolic heart failure.
At present, the effective drug treatment of diastolic heart failure is not certain, and the available reference data is still limited, so a medical device for auxiliary treatment is provided based on the principle of diastolic heart failure.
Disclosure of Invention
In view of the above-mentioned deficiencies in the prior art, the present invention provides a ventricular assist device.
In order to achieve the purpose, the invention adopts the following technical scheme:
a ventricular assist device comprises a bracket, a connecting line and an anchoring structure; the support comprises a plurality of elastic support arms and an annular support, and the rear ends of the elastic support arms are connected with the annular edge of the annular support to form a claw-shaped support structure matched with the ventricular structure and used for radially supporting the inner wall of the ventricle; the anchoring structure is anchored in the ventricle, the annular support is connected with the anchoring structure through a connecting line to fix the support in the ventricle, the outer side of the elastic support arm is in contact with the inner wall of the ventricle, the elastic support arm is stressed and compressed when the ventricle contracts, and the elastic support arm is restored and expanded when the ventricle relaxes.
Preferably, the front end of the elastic support arm is provided with a protection pad structure, and when the outer side of the elastic support arm is in contact with the inner wall of the ventricle, the protection pad structure is used for increasing the contact stress area.
Preferably, one end of the protection pad structure, which is far away from the annular support, is provided with an arc angle, and the arc angle is bent towards the claw center of the claw-shaped support structure.
Preferably, the protective pad structure is wrapped by a coating film, and the coating film is made of a high polymer material and/or animal-derived tissues so as to enhance the compatibility of the protective pad structure in contact with the inner wall of the ventricle.
Preferably, the coating film is internally provided with a drug coating layer for coating and releasing the drug.
Preferably, the anchoring end of the anchoring structure has any one of a barb structure, a thread structure, a surgical biological patch structure, and an atrial/ventricular septum occluder structure.
Preferably, a folding structure is arranged between adjacent elastic support arms of the elastic support arms.
Preferably, the number of the elastic support arms is 3-6.
Preferably, the wall thickness of the stent is 0.2-1.2 mm.
Preferably, the arm length of the elastic support arm is 35-55 mm; when the support is in a ventricular environment and the elastic support arms are in an unstressed state, the maximum diameter of the formed claw-shaped support structure is 45-100 mm.
A ventricular assist device method of use comprising the steps of:
s1, compressing a support to the size of a conveying pipe of the device under the deformation condition of the material of an elastic support arm and the material of an anchoring structure, and filling the support into the conveying pipe;
s2, inserting a delivery pipe through an apical implantation path or a static/arterial implantation path;
s3, if the implant is implanted through the cardiac apex implantation path, after reaching the designated position, sequentially releasing the bracket, the connecting line and the anchoring structure, and withdrawing the conveying pipe; the elastic support arm is deformed under the heart environment and firstly attached to the inner wall of the heart chamber to radially support the inner wall of the heart chamber, and then the anchoring structure falls into the apex of the heart and is deformed and anchored at the apex of the heart under the heart environment;
if the implant is implanted through the static/artery, after reaching the designated position, the anchoring structure, the connecting line and the bracket are sequentially released, and the conveying pipe is retracted; the anchoring structure falls into the apex of the heart firstly, deforms and anchors at the apex of the heart under the heart environment, and then the elastic support arm deforms and fits with the inner wall of the ventricle under the heart environment to radially support the inner wall of the ventricle.
Compared with the prior art, the invention has the beneficial effects that:
the ventricular assist device and the using method thereof can be compressed when the ventricles contract, store energy and generate radial supporting force, and assist the diastole of the ventricles by utilizing the radial supporting force when the ventricles relax, so that the cardiac function is improved.
Drawings
FIG. 1 is a schematic diagram of the overall structure of a ventricular assist device and method of use according to a first embodiment of the present invention;
FIG. 2 is a schematic view of a ventricular assist device and its method of use according to a first embodiment of the present invention in a transapical implantation path;
FIG. 3 is a schematic view of a transvenous/arterial access pathway in accordance with a first embodiment of the ventricular assist device and method of use of the device of the invention;
FIG. 4 is a schematic view of a ventricular assist device and its method of use according to a first embodiment of the present invention after implantation in the heart;
FIG. 5 is a schematic illustration of a patch structure of an anchoring structure of a first embodiment of a ventricular assist device and method of use thereof in accordance with the present invention;
FIG. 6 is a schematic view of the thread configuration of the anchoring structure of the first embodiment of the ventricular assist device and method of use thereof in accordance with the present invention;
wherein: 1. a support; 11. an elastic support arm; 12. a pad structure; 13. a circular arc angle; 14. an annular support; 2. a connecting wire; 3. an anchoring structure.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention, the following description will explain the embodiments of the present invention with reference to the accompanying drawings. It is obvious that the drawings in the following description are only examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.
The first embodiment is as follows:
as shown in fig. 1 to 6, the present embodiment provides a ventricular assist device including a stent 1 supporting an inner wall of a ventricle, a connection wire 2 and an anchoring structure 3. The structure of the bracket 1 is matched with the original structure of the ventricle, is claw-shaped in the ventricular environment, can fully contact the heart when in use, and can contract and relax along with the heart. An anchoring structure 3 is connected to the rear end of the bracket 1 through a connecting line 2, so as to firmly fix the ventricular assist device in the ventricle. The ventricular assist device of the embodiment can be placed in a ventricle by matching with a matched blood vessel input device, and is compressed when the ventricle contracts, so that energy is stored and radial supporting force is generated. And when the heart chamber is relaxed, the radial supporting force is utilized to assist the relaxation of the heart chamber, thereby improving the heart function.
Specifically, the bracket 1 comprises a plurality of elastic bracket arms 11 and an annular support 14, the rear ends of the elastic bracket arms 11 are connected with the annular edge of the annular support 14, so as to form a claw-shaped supporting structure matched with the ventricular structure, when the claw-shaped supporting structure is contacted with the ventricle, the outer side of the elastic support arm 11 is contacted with the inner wall of the ventricle, the front end of the elastic support arm 11 is stably attached in the ventricle at the moment and contracts and expands along with the heartbeat, in order to reduce the compression pressure of the front end of the arm of the bracket 1 on the heart wall and avoid damaging the original structure of the ventricle, the protection pad structure 12 is arranged at the front end of the elastic support arm 11, the protection pad structure 12 can be made of the same material as the elastic support arm 11, the protection pad structure 12 is approximately circular, and the surface diameter of the protection pad structure 12 is larger than the arm width of the elastic support arm 11, so that the contact area of the protection pad structure 12 with the inner wall of the ventricle is increased, and the stress is reduced; further, the membrane which is wrapped by the protective pad structure 12 and is made of polymers and/or biological tissues is used for enhancing the compatibility of the membrane contacting with the inner wall of the ventricle, the polymers are usually TPU, PET, e-PTFE, PTFE and the like, animal-derived tissues such as common pigskin and the like can repair, replace and regenerate organism tissues, meanwhile, due to the existence of the coating, a coating layer can be added into the coating to coat and release corresponding medicines aiming at the ventricular diseases, and the device can be used for assisting in treatment and assisting in medicine treatment or assisting in medicine to accelerate the compatibility of the device and the ventricle; preferably, the whole stent 1 can be wrapped by the covering film, so that the compatibility of the whole stent 1 is improved. In order to further avoid clamping and stabbing the conveying device or the ventricular structure when the elastic support arm 11 is placed into the ventricle, the front end of the arm rod is slightly bent, namely, one end of the protection pad structure 12 far away from the annular support 14 is provided with an arc angle 13, and the bending direction of the arc angle 13 faces to the jaw center of the jaw-shaped support structure.
Preferably, the elastic support arm 11, the protection pad structure 12 and the annular support 14 are made of nickel-titanium alloy, the elasticity of the elastic support arm 11 is provided by the memory of nickel-titanium alloy, and the elastic support arm can be manufactured in any one or more modes of laser cutting, linear cutting, 3D printing, injection molding or weaving, and correspondingly, the whole structure of the support 1 can be any one of a net-shaped structure, a perforated structure, an integrated structure and a hollowed-out structure. The annular support 14 is connected with the anchoring structure 3 through the connecting line 2, and the material of the connecting line 2 is one or more of high polymer material PET, PTFE, biological tissue and tissue engineering material. The anchoring structure 3 can be any one of a barb structure, a thread structure, a metal bracket 1 structure, an atrium/ventricle occluder structure, a surgical biological patch structure and a high molecular structure which can play a role in anchoring. The number of the elastic support arms 11 is generally set to be 2-100, since the heart is the main body weight organ, the operation is in principle simpler, less and better, the experimental balance between stability and simplicity is better, the most preferable number is 3-6, likewise, the wall thickness of the support 1 is determined by the material characteristics, the nickel titanium metal can be set to be 0.1-2.0mm thick, the experimental balance is preferably 0.2-1.2mm in structural strength and cost, and the size is matched with the number of the elastic support arms 11 to meet the strength matched with the contraction and expansion of the heart. Considering that the ventricular assist device of the present embodiment mainly aims at ventricular diastolic heart failure, when the stent 1 is in a ventricular environment and the elastic stent arms 11 are in an unstressed state, the formed claw-shaped supporting structure is slightly larger than a ventricle, in combination with the existing medical data, the size difference of human hearts is not large, that is, the maximum diameter of the claw-shaped supporting structure is set to be between 30 and 120mm, the length of the elastic stent arms 11 is set to be between 25 and 70mm, in combination with a heart with symptoms is slightly larger than a heart with normal persons and the production cost control, preferably, the maximum diameter of the claw-shaped supporting structure is 45 to 100mm, and preferably, the length of the elastic stent arms 11 is between 35 and 55mm, the stent 1 under the data is most suitable for the ventricle of patients with normal patients, so that customization can be effectively reduced, and the treatment cost can. Preferably, a folding structure, such as a fold-shaped connection or a hinged structure connection, can be arranged between the elastic support arms 11, so as to enhance the motion stability of the support 1.
The ventricular assist device of this embodiment is made of nitinol, when they are not stressed in the ventricular environment, they are in the expanded state and when they are stressed and deformed, they can provide energy in radial or axial direction or in lateral direction, and can cooperate with the delivery device of the self-expandable system to perform the operation, at a specific temperature, they can be compressed in a large amount and put into the sheath, then through the catheter, through the open heart surgery transfemoral mode or through the apex, implant into the heart, for example: after the target position is reached through static/arterial puncture, the anchoring structure 3 is released through the conveying system, after the anchoring structure 3 is fixed on the heart, the annular support 14 and the elastic support arm 11 are sequentially released, the shape is restored at the ventricular ambient temperature, the ventricle is radially supported, and the ventricle is compressed when being contracted, stores energy and generates radial supporting force. And when the heart chamber is relaxed, the radial supporting force is utilized to assist the relaxation of the heart chamber, thereby improving the heart function.
Further, a ventricular assist device using method comprises the following steps:
s1, under the condition that the material of an elastic support arm 11 and the material of an anchoring structure 3 deform, a support 1 is compressed to the size of a conveying pipe of the device and is arranged in the conveying pipe; specifically, for example, the nickel-titanium alloy can be softened and easily deformed at a specific temperature after being formed in a memory mode, under the condition, the whole bracket 1 is changed into a strip shape, the barb structure of the anchoring structure 3 is shaped into a straight barb shape, and at the moment, the whole device is compressed and plugged into the conveying device;
s2, inserting a delivery pipe through an apical implantation path or a static/arterial implantation path;
s3, if the implant is implanted through the cardiac apex implantation path, after reaching the designated position, sequentially releasing the bracket 1, the connecting wire 2 and the anchoring structure 3, and withdrawing the conveying pipe; the elastic support arm 11 deforms under the cardiac environment and is firstly attached to the inner wall of the ventricle to radially support the inner wall of the ventricle, and then the anchoring structure 3 falls into the apex position and deforms and is anchored at the apex under the cardiac environment;
if the implant is implanted through the static/artery, after reaching the designated position, the anchoring structure 3, the connecting line 2 and the bracket 1 are sequentially released, and the conveying pipe is retracted; the anchoring structure 3 firstly falls into the apex of the heart, deforms and anchors at the apex of the heart under the heart environment, and then the elastic support arm 11 deforms and fits the inner wall of the ventricle under the heart environment to radially support the inner wall of the ventricle. The environment of the heart can make the nickel-titanium alloy gradually return to the memory shape, for example, the stent 1 returns to the claw shape from the strip shape to realize radial support, and the straight pricks of the anchoring structure 3 return to the barb shape to realize anchoring.
The ventricle auxiliary device of this embodiment can cooperate and use the little wound to intervene the mode and get into the heart, and the operation wound is less, and the operation risk is low, and the structure is simple and easy simultaneously, and manufacturing process realizes easily, can realize the volume production and reduce manufacturing cost, when satisfying human implant treatment demand, reduces too much implant to the injury of human body, and the compatibility is superior, has vast prospect as auxiliary treatment medical instrument.
It should be noted that the above-mentioned only illustrates the preferred embodiments and principles of the present invention, and that those skilled in the art will be able to make modifications to the embodiments based on the idea of the present invention, and that such modifications should be considered as the protection scope of the present invention.
Claims (10)
1. A ventricular assist device comprising a stent, a connecting wire and an anchoring structure; the support comprises a plurality of elastic support arms and an annular support, and the rear ends of the elastic support arms are connected with the annular edge of the annular support to form a claw-shaped support structure matched with the ventricular structure and used for radially supporting the inner wall of the ventricle; the anchoring structure is anchored in the ventricle, the annular support is connected with the anchoring structure through a connecting line to fix the support in the ventricle, the outer side of the elastic support arm is in contact with the inner wall of the ventricle, the elastic support arm is stressed and compressed when the ventricle contracts, and the elastic support arm is restored and expanded when the ventricle relaxes.
2. A ventricular assist device as claimed in claim 1, wherein the front end of the flexible stent arm has a pad structure for increasing the force area of contact when the outside of the flexible stent arm contacts the inner wall of the ventricle.
3. A ventricular assist device as claimed in claim 2, wherein an end of the pad structure remote from the annular abutment has a radiused corner, the radiused corner being curved towards the arch of the claw-type support structure.
4. A ventricular assist device as claimed in any one of claims 2 or 3, wherein the pad structure is wrapped with a coating made of a polymeric material and/or animal derived tissue to enhance compatibility with contact with the inner wall of the ventricle.
5. A ventricular assist device as claimed in claim 4, wherein the coating has a drug coating therein for coating and releasing the drug.
6. A ventricular assist device as claimed in claim 1, wherein the anchoring end of the anchoring structure has any one of a barb structure, a thread structure, a surgical biologic patch structure, and an atrial/ventricular septum occluder structure.
7. A ventricular assist device as claimed in claim 1, wherein a folded configuration is provided between adjacent ones of the plurality of resilient stent arms.
8. A ventricular assist device as claimed in claim 1, wherein the number of resilient support arms is 3-6.
9. A ventricular assist device as claimed in claim 1, wherein the stent wall thickness is 0.2-1.2 mm; the arm length of the elastic support arm is 35-55 mm; when the support is in a ventricular environment and the elastic support arms are in an unstressed state, the maximum diameter of the formed claw-shaped support structure is 45-100 mm.
10. A method of using a ventricular assist device, comprising the steps of:
s1, compressing a support to the size of a conveying pipe of the device under the deformation condition of the material of an elastic support arm and the material of an anchoring structure, and filling the support into the conveying pipe;
s2, inserting a delivery pipe through an apical implantation path or a static/arterial implantation path;
s3, if the implant is implanted through the cardiac apex implantation path, after reaching the designated position, sequentially releasing the bracket, the connecting line and the anchoring structure, and withdrawing the conveying pipe; the elastic support arm is deformed under the heart environment and firstly attached to the inner wall of the heart chamber to radially support the inner wall of the heart chamber, and then the anchoring structure falls into the apex of the heart and is deformed and anchored at the apex of the heart under the heart environment;
if the implant is implanted through the static/artery, after reaching the designated position, the anchoring structure, the connecting line and the bracket are sequentially released, and the conveying pipe is retracted; the anchoring structure falls into the apex of the heart firstly, deforms and anchors at the apex of the heart under the heart environment, and then the elastic support arm deforms and fits with the inner wall of the ventricle under the heart environment to radially support the inner wall of the ventricle.
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| CN202010036140.XA CN111110938A (en) | 2020-01-14 | 2020-01-14 | Ventricular assist device and using method thereof |
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| CN202010036140.XA CN111110938A (en) | 2020-01-14 | 2020-01-14 | Ventricular assist device and using method thereof |
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| CN111110938A true CN111110938A (en) | 2020-05-08 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114376768A (en) * | 2021-12-03 | 2022-04-22 | 上海竑宇医疗科技有限公司 | Hypertrophic cardiomyopathy therapeutic apparatus for cat |
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