CN113440308A - Valve prosthesis with variable positioning part and conveying system thereof - Google Patents
Valve prosthesis with variable positioning part and conveying system thereof Download PDFInfo
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- CN113440308A CN113440308A CN202010692576.4A CN202010692576A CN113440308A CN 113440308 A CN113440308 A CN 113440308A CN 202010692576 A CN202010692576 A CN 202010692576A CN 113440308 A CN113440308 A CN 113440308A
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
Abstract
The invention belongs to the field of medical instruments, and particularly relates to a valve prosthesis with a variable positioning piece and a conveying system thereof, which comprise a support body, a positioning piece and a prosthetic valve, wherein the prosthetic valve is connected to the support body; the positioning piece provided by the invention is provided with the fixed end and the free end, and the positioning arm can be axially pulled and pulled by the control piece during loading, so that the positioning arm is deformed, the positioning piece and the bracket body cannot be overlapped during loading, the pipe diameter of a sheath loading pipe of a conveying system is reduced, and the wound to a patient is greatly reduced.
Description
The technical field is as follows:
the invention belongs to the field of medical instruments, and particularly relates to a valve prosthesis with a variable positioning part and a conveying system thereof.
Background art:
aortic stenosis is mainly caused by sequelae of rheumatic fever, congenital abnormalities of aortic valve structure or senile calcification of aortic valve. Patients are asymptomatic during the compensation period, and patients with severe aortic stenosis are often accompanied by symptoms of lassitude, dyspnea (exertional or paroxysmal), angina pectoris, vertigo or syncope, and even sudden death.
The aortic valve is opened when the ventricle contracts, the blood in the left ventricle enters the aorta and is emitted to the whole body, the aortic valve is closed when the ventricle relaxes, the blood in the aorta is prevented from flowing back to the left ventricle, and if the aortic valve is not closed completely, the aortic valve cannot be closed tightly in the diastole, so that the blood reversely flows into the left ventricle from the aorta.
In the treatment of aortic valve disease, surgical valve replacement is the traditional effective treatment. However, patients with such diseases are many elderly patients, suffer from multiple organ diseases, are difficult to be subjected to surgical operation, and become patients who are not expected to be clinically treated. In addition, the etiology of degenerative aortic valvular disease is still unclear, and the etiology cannot be treated, and no effective method for inhibiting the development of degenerative aortic valvular disease exists, so that the curative effect of the medicine is poor. The ideal treatment for aortic valve disorders would improve both the symptoms and longevity of the patient. Percutaneous aortic balloon angioplasty, performed in the early years, has been used to treat aortic stenosis, but either single-center data or multi-center registration data have been found to be ineffective in the long term. Surgical valve replacement remains a major treatment option in the country. In recent years, some scholars at home and abroad carry out basic and clinical researches on percutaneous aortic valve replacement and have achieved breakthrough progress. Provides an effective treatment method for high-risk senile degenerative aortic valve patients needing surgical valve replacement. In 2002, Cribier et al succeeded in Transcatheter Aortic Valve Replacement (TAVR), and more than 5 million TAVR surgeries have been performed worldwide, and studies worldwide have shown: this technique is safe and effective for patients who are unable to undergo surgical valve replacement or who are at high risk of surgical valve replacement. Although most of patients who are subjected to TAVR surgery have high risk, the survival rate of the patients after 30 days is higher than 90%, and the hemodynamic index of the patients after TAVR surgery is obviously improved.
However, the autologous aortic insufficiency is still classified as contraindication of TAVR. The main reason is that accurate positioning and precise release of the stent-valve are the most critical technical points in TAVR surgery. The aortic valve has openings for the left and right coronary arteries, and the valve is positioned adjacent to the mitral valve, so if the positioning and releasing are not accurate, fatal complications such as coronary occlusion or massive mitral regurgitation can occur. The conventional TAVR instrument, whether SAPIEN or CoreValve, is primarily used in patients with severe aortic stenosis and is not suitable for patients with aortic regurgitation. In the prior art, the instrument design for aortic valve regurgitation patients
It is well known that, for example, Jena Valve and Acurate at foreign countries and J-Valve at home adopt a structure similar to a self-body Valve leaflet positioning piece for positioning three sinuses of an aortic Valve, which is beneficial to the accurate positioning implantation of the stent. However, the above devices are still mostly inserted from the apex of the heart, and still have great trauma to the patient, which cannot be considered as percutaneous implantation in a strict sense. In order to solve the problem of considering the overlarge positioning piece and the sheath pipe of the autologous valve leaflet, domestic scholars and engineers make some conceptual attempts.
Patent CN2010155694.8 describes a prosthetic valve with an articulating valve clasper comprising a support frame, radially expandable between a compressed state and an expanded state, said support frame having an outer surface defining a central aperture about an axis along an inflow and outflow direction; a plurality of resilient leaflets attached to the support frame and providing one-way valves in said air when the support frame is in the expanded state; and at least one valve clasper axially movably attached to the support frame, the at least one valve clasper being movable along the shaft between a nested position in which the at least one valve clasper is in a nested position with the support frame at a position adapted to contact or be adjacent to the native valve and an engaged position in which the at least one valve clasper is offset from the support frame. The disadvantages of this design are: the valve buckle is connected by being movably connected to the support frame, so that the valve buckle may have position deviation in the moving process, and the valve buckle cannot be connected to the originally set position after moving towards the support frame; secondly, no effective fixing structure is arranged between the valve buckle and the support frame, and after the valve prosthesis is implanted, the valve buckle may have relative displacement relative to the support frame, so that the stability of the support frame at the intracardiac position is reduced, and the use of the valve is influenced.
Patent CN201620032889.6 provides a transcatheter aortic valve device comprising: a main support; a leaflet fixed inside the middle part of the main bracket; a skirt edge fixed along the periphery of the inner side of the main bracket and fixed with the valve leaf; wherein, the upper end of the main bracket forms an upper bell mouth structure in a three-petal form; three upper end circular connecting claws for loading the main bracket are arranged at the upper end of the upper bell mouth structure; the bottom end of the main bracket is provided with a lower flared structure which is used for reducing the leakage around the valve and expands outwards; the lower end of the lower bell mouth structure is provided with three lower end circular connecting claws; the aortic valve device also comprises a positioning ring which is positioned at the lower side of the main support and used for positioning, the positioning ring comprises three V-shaped or U-shaped arc sections, the ends of the V-shaped or U-shaped arc sections are connected with each other to form a ring shape, and three positioning circular connecting claws are formed at the ends; the lower end circular connecting claw is connected with the corresponding positioning circular connecting claw through a flexible positioning line respectively. Although this design has reduced the diameter of valve prosthesis when the dress sheath by a wide margin, the circular connection claw of lower extreme is connected through flexible location line respectively with the circular connection claw of corresponding location, when the release location, because blood is toward the upper punch, does not set up effectual restriction/fixed knot structure between the circular connection claw of location and the circular connection claw of lower extreme, leads to the circular connection claw of location probably by "dash run", leads to its can not effective accurate location.
In summary, the above-mentioned fixing method has a first disadvantage that the connection position of the valve buckle and the support frame is not accurate enough and the valve buckle is easy to shift in position when being positioned, and a second disadvantage that no effective limiting structure is arranged between the positioning member and the support frame, so that the positioning member can effectively resist the impact force of blood when being released, and the positioning member can be released to the target position accurately.
The invention content is as follows:
the object of the present invention is to improve and remedy the drawbacks of the prior art by proposing a valve prosthesis with a variable positioning element and a delivery system therefor that effectively solve the above-mentioned problems. The invention has the characteristics of accurate positioning, stable clamping, firm clamping, reduction of valve leakage and the like, and solves the problems that the positioning piece of the prosthesis in the prior art can not resist the impact force of blood when being released and the release positioning is not accurate.
The purpose of the invention is realized by the following technical scheme:
the utility model provides a valve prosthesis with variable setting element, includes stake body, setting element and artificial valve, artificial valve is connected on the stake body, the setting element includes registration arm and control, the one end cooperation of control is connected on the registration arm, the registration arm has stiff end and free end, stiff end and stake body fixed connection work as the control pulling during the registration arm, the free end of registration arm moves along the direction of height of stake body, when loosening during the control, the registration arm progressively resumes for predetermineeing the shape.
The object of the invention can be further realized by the following technical scheme:
in some embodiments, the number of the positioning members is 3, the positioning members are positioned at the sinus floor of the natural aortic sinus of the patient after being released, and the positioning members provide a certain supporting force for the stent body in the heart, so that the stent body is prevented from being washed away by blood in the heart while the stent body is safely and accurately released/implanted to a target position.
In some embodiments, the positioning arm includes a retaining section at a free end of the positioning arm and an elastically deformable section between the retaining section and a fixed end of the positioning arm.
In some embodiments, the elastic deformation section is flexible relative to the holding section, and when the positioning element is transformed from the restraining state to the releasing state, the elastic deformation section deforms until the elastic deformation section returns to the preset shape.
In some embodiments, the control member includes a push-pull rod having one end cooperatively coupled to the positioning arm and a locking structure disposed at the other end of the push-pull rod.
In some preferred embodiments, the locking structure is a plurality of protrusions which are uniformly and symmetrically arranged on the left side and the right side of the push-pull rod.
In some preferred embodiments, the protrusion is made of a metal memory material (such as nitinol), and when the positioning member is released in the heart, the positioning member drives the locking structure thereof to return to the preset shape, so that the protrusion is fixed through the fixing hole, and the connection between the locking structure and the fixing hole is similar to a 'snap-fit' form.
In some embodiments, the bracket body is provided with a fixing hole corresponding to the locking structure, and when the control member is released, the locking structure is connected with the fixing hole in a matching manner.
In some preferred embodiments, the fixing hole is arranged at the distal end of the stent body, the control member is arranged in the fixing hole in a penetrating way, when the valve prosthesis is sheathed, the positioning member is in a limiting state, and the control member axially draws the positioning arm so that the positioning arm is deformed, and therefore the positioning arm and the control member cannot be overlapped, and the diameter of the sheath tube can be greatly reduced when the valve prosthesis is loaded.
In some embodiments, the control members are arranged in a herringbone configuration; the control piece has bifurcated one end and is connected on the positioning arm, and two connecting points of the control piece on the positioning arm are arranged in a bilateral symmetry mode by taking the push-pull rod as an axis, so that the stability of a connecting structure of the control piece can be guaranteed, and the deviation of a path cannot occur.
In another embodiment, the control member is a wire or a thread, the control member is detachably connected with the positioning arm, and when the control member is released, the control member is separated from the positioning arm, so that the positioning arm gradually restores to the preset shape.
In some preferred embodiments, the control member may be a single strand or wire or a plurality of strands or wires, and the end of the control member connected to the positioning arm is detachably connected, so that the design aims to greatly reduce the number of implants, reduce the contact and stimulation to the endocardial tissue and facilitate the postoperative recovery of the patient.
In some embodiments, the positioning arm is made of a shape memory material, and the preset shape of the positioning arm is a U shape, a V shape or a W shape.
In some embodiments, the locating arm surface is provided with the barb, perhaps the locating arm surface is the tectorial membrane, the barb is made for metal memory material, and the locating arm is after resumeing preset shape, and the barb can increase the frictional force to the intracardiac tissue, can effectively avoid the circumstances that the stake body drops in the heart.
In some embodiments, the surface of the stent body is covered with a membrane, and the membrane material comprises a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron or an animal-derived material.
The invention can be realized by the following technical scheme:
a valve prosthesis system with a variable positioning part comprises a valve prosthesis with a positioning part, a control handle, an outer sheath and a controllable release device, wherein the valve prosthesis with the positioning part comprises a support body, a prosthetic valve and a positioning part which are connected to the support body in a matched mode, the support body is connected with the controllable release device in a matched mode, the positioning part comprises a positioning arm and a control part, one end of the control part is detachably connected with the positioning arm, the other end of the control part is connected with the control handle in a matched mode, the positioning arm is provided with a fixed end and a free end, the fixed end is fixedly connected with the support body, when the control part is pulled axially by operating the control handle, the free end of the positioning arm moves along the height direction of the support body, the positioning arm is gradually retracted into a gap between the support body and the outer sheath until an elastic adaptive area and a part of a support where the prosthetic valve is located are not overlapped with each other, the positioning arm is in a limiting state at the moment; when the control handle is operated reversely, the positioning arm gradually returns to a preset shape, the positioning arm gradually extends out of a gap between the bracket body and the outer sheath and returns to the preset shape, and the positioning arm is in a release state; before the stent body is not completely separated from the controllable release device, the positioning arm can be switched between the limiting state and the release state for a plurality of times; the controllable release device comprises a distal release device and a proximal release device, the distal release device is positioned at the distal end part of the valve prosthesis system, the distal end part of the support body is arranged in the distal release device to be in a folded state before the distal end part of the support body is completely separated from the distal release device; the proximal releasing device is arranged in the outer sheath and is matched and detachably connected with the proximal end of the bracket body, and the proximal part of the bracket body is limited to be released by the proximal releasing device before the positioning part and the distal part of the bracket body are not completely released.
Compared with the prior art, the technical scheme has the advantages that:
1. the positioning piece provided by the invention is provided with the fixed end and the free end, and the positioning arm can be axially pulled and pulled by the control piece, so that the positioning arm deforms, the positioning piece and the stent body cannot be overlapped during loading, the diameter of a sheath tube loaded by a conveying system of the positioning piece is reduced during loading, a replacement operation of a patient through a vascular path is realized, the wound on the patient is greatly reduced, and the postoperative recovery of the patient is facilitated;
2. the invention is characterized in that the diameter of the loading sheath tube is reduced by the positioning arm in a turnover mode in the prior art, although the diameter of the loading sheath tube can be reduced, the inner wall tissue of the aorta is easy to scrape in the process of releasing and turning, so that the positioning arm cannot turn to a preset shape;
3. the positioning piece is provided with the fixed end permanently connected with the support body, so that the positioning arm can reach the designated position according to the preset path no matter the positioning arm is axially stretched, deformed or restored to the preset shape, the deviation or dislocation of the positioning piece on the path in the process is avoided, the accuracy of the positioning piece in the releasing and positioning process is improved, and the success rate of the operation is improved;
4. the control piece is provided with the push-pull rod and the locking structure, when the positioning piece is in a release state, the locking structure is connected with the support body in a matched mode, the positioning piece and the support body are provided with a plurality of connecting points, the connecting stability between the positioning piece and the support body can be improved, the impact force of intracardiac blood flow can be effectively resisted, and then the positioning piece can be prevented from turning outwards to the greatest extent through a multi-dimensional connecting mode, so that the valve prosthesis is prevented from falling off;
5. the control piece is made of shape memory materials and has rigidity, so that when the positioning piece is in a release state, the control piece is matched and connected with the support body to increase the supporting force of the positioning piece, and the stability of the support body in the intracardiac position is ensured;
6. in some embodiments of the invention, the control element is arranged as a wire or a thread, the control element is detachably connected with the positioning arm, and when the positioning element is in a release state, the control element is separated from the positioning arm, so that the positioning arm is restored to a preset shape.
Drawings
FIGS. 1a-1e are schematic views of a heart valve prosthesis of the present invention.
Fig. 2a-2b are schematic views illustrating a process of the control member moving the positioning arm in a natural state of the heart valve prosthesis, wherein fig. 2b is a schematic side view of fig. 2 a.
Fig. 3a-3c are schematic views illustrating the process of controlling the pumping of the positioning arms of the heart valve prosthesis in the delivery system.
Fig. 4a-4g are schematic views illustrating a releasing process of the heart valve prosthesis.
Fig. 5a-5d are schematic structural views of the positioning arm in a V-shaped structure.
Fig. 6a-6d are schematic structural views of the positioning arm in a W-shaped structure.
Fig. 7 is a schematic structural diagram of another embodiment.
Fig. 8a-8c are schematic views illustrating a process of controlling the pumping of the positioning arms of the heart valve prosthesis in another embodiment of the delivery system.
Fig. 9a-9d are schematic views illustrating a release process of the heart valve prosthesis according to another embodiment.
Fig. 10a-10h illustrate two prior art methods of loading and releasing a retainer for a valve prosthesis, wherein fig. 10c is an enlarged view of a portion of fig. 10 b.
The specific implementation mode is as follows:
in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and examples.
The far end refers to the end of the valve prosthesis far away from the apex of the heart, and the near end refers to the end of the valve prosthesis near the apex of the heart.
The first embodiment is as follows:
when the heart valve prosthesis is used for treating aortic valve diseases, as shown in fig. 1a-1d, the heart valve prosthesis comprises a stent body 1, a positioning member 2 and a prosthetic valve 3, the prosthetic valve 3 is connected to the stent body 1, the positioning member 2 comprises a positioning arm 21 and a control member 22, one end of the control member 22 is connected to the positioning arm 21 in a matching manner, the positioning arm 21 has a fixed end 211 and a free end 212, the fixed end 211 is fixedly connected to the stent body 1, when the control member 22 pulls the positioning arm 21, the free end 212 of the positioning arm 21 moves along the height direction of the stent body 1, and when the positioning member 2 is in a release state, the positioning arm 21 returns to a preset shape (as shown in fig. 2 a); when the positioning piece 2 is in a limiting state, the free end 212 of the positioning arm 21 is not overlapped with the stent body 1, the pipe diameter of the valve sheath tube loaded by the positioning piece can be greatly reduced, the replacement operation of the vascular path of a patient is realized, the wound of the patient is greatly reduced, and the postoperative recovery of the patient is facilitated.
In this embodiment, the number of the positioning members 2 is 3, the positioning members 2 are located at the sinus floor of the natural aortic sinus of the patient after being released, and the positioning members 2 provide a certain supporting force for the stent body 1 in the heart, so that the stent body 1 is prevented from being flushed away by intracardiac blood while the stent body 1 is ensured to be safely and accurately released/implanted to a target position.
In this embodiment, the positioning member 2 can also play a role in clamping the autologous valve leaflets.
In some embodiments, the positioning arm 21 comprises a retaining section 213 and an elastically deformable section 214, the retaining section 213 is located at the free end 212 of the positioning arm 21, and the elastically deformable section 214 is located between the retaining section 213 and the fixed end 211 of the positioning arm 21 (as shown in fig. 1 b).
In some embodiments, the elastically deformable section 214 is flexible relative to the retaining section 213, and when the positioning element 2 is transformed from the restraining state to the releasing state, the elastically deformable section 214 deforms until it returns to the preset shape; because the elastic deformation section 214 is flexible relative to the retaining section 213, in the recovery process, the control member 22 axially pushes the positioning arm 21, so that the elastic deformation section 214 is converted from the straightened state to the bending state close to the "U" shape until the elastic deformation section returns to the preset straightened state (as shown in fig. 1 e), and in the process, the push-pull direction of the control member 22 is always kept axially, and meanwhile, the eversion of the positioning arm 21 in the recovery process is reduced, and the positioning arm is prevented from scraping the blood vessel wall of the patient; in contrast, as shown in fig. 10a to 10d (in the figures, arcs and arrows indicate the movement locus of the positioning element 2 from the restricted state in the sheath to the released process), the positioning element 2 in the prior art is turned over to achieve the purpose of reducing the diameter of the loaded tube, but the positioning element 2 is very difficult to load, and the positioning element 2 needs to be turned over to load, and the positioning element 2 is also at risk of breaking when turned over, and meanwhile, when the positioning element 2 is released, the turning process scrapes and increases the vascular wall tissue, so that the release of the vascular wall tissue is difficult, the vascular wall tissue is injured, and the positioning element 2 cannot be recovered after being released, and the fault tolerance is low; as shown in fig. 10 f-10 h, when the positioning element 2 in the prior art is loaded and released, the positioning element is always overlapped with the stent, so that the loading tube diameter is larger, the requirement on the access mode is higher, percutaneous implantation cannot be truly realized, and the larger the wound caliber of the patient is, the more the postoperative recovery of the patient is unfavorable; as shown in fig. 2a and 2b (front structural view of the valve prosthesis), when the positioning member 2 is switched between the restraining state and the releasing state, a "rounded corner" is generated between the elastically deforming section 214 of the positioning member 2 and the stent body 1, and as can be seen from fig. 2b (side structural view of the valve prosthesis), the "rounded corner" is not existed in the lateral direction; compared with the technical scheme that the positioning piece in the prior art adopts the overturning (as shown in fig. 10 c), when the positioning piece is overturned, the 'round angle' exists in the lateral direction when the positioning piece is observed from the side view; therefore, the retaining section 213 and the elastic deformation section 214 are arranged on the positioning arm 21, so that the direction of the 'round angle' is changed, and the path of the positioning arm 21 can greatly reduce the conditions that the positioning member 2 turns outwards and scrapes and increases to the inner wall tissue of the aorta in the releasing process when the positioning arm 21 is mutually changed between the limiting state and the releasing state.
In some embodiments, the control member 22 includes a push-pull rod 221 and a locking structure 222, wherein one end of the push-pull rod 221 is connected to the positioning arm 21 in a matching manner, and the locking structure 222 is disposed at the other end of the push-pull rod 221.
In this embodiment, the locking structure 222 is a plurality of protrusions 223 uniformly and symmetrically disposed on the left and right sides of the push-pull rod 221; the protrusion 223 is made of a metal memory material (such as nitinol), and when the positioning member 2 is released in the heart, the positioning member 2 drives the locking structure 222 thereof to return to the preset shape, so that the protrusion 223 penetrates through the fixing hole 11 to be fixed, and at this time, the connection between the locking structure 222 and the fixing hole 11 is similar to a "snap" form.
In this embodiment, the bracket body 1 is provided with a fixing hole 11 corresponding to the locking structure 222, and when the positioning element 2 is in a release state, the locking structure 222 is connected with the fixing hole 11 in a matching manner; the fixing hole 11 is arranged at the far end of the stent body 1, the control part 22 is arranged in the fixing hole 11 in a penetrating way, when the valve prosthesis is sheathed, the positioning part 2 is in a limiting state, the control part 22 axially draws the positioning arm 21, so that the positioning arm 21 is deformed, the positioning arm 21 and the control part 22 are not overlapped, and the diameter of a sheath tube during valve loading can be greatly reduced (as shown in figures 3a-3 c); be different from among the prior art, setting element 2 is set up in the periphery of stake body 1, and when the valve loaded, setting element 2 took place to overlap with stake body 1, will increase its pipe diameter that loads the sheath pipe certainly, leads to its replacement operation can not implant through the skin, and must implant the replacement through the apex of the heart, and is great to patient's wound, also does not benefit to patient's postoperative and resumes.
In some more preferred embodiments, two or more locking structures 222 are disposed on the push-pull rod 221, and the fixing holes 11 corresponding to the locking structures 222 are also disposed on the support body 1; the design has the advantages that: the connection stability between the push-pull rod 221 and the support body 1 can be enhanced, the situation that the positioning arm 21 turns outwards and scrapes and increases to the inner wall of the aorta in the process of recovering the preset shape can be effectively avoided, and the success rate of releasing and recovering the positioning piece 2 is effectively improved.
In the present embodiment, the control member 22 is made of a shape memory material; the control member 22 may be made of a metal memory material (e.g., nitinol), the control member 22 being configured to be rigid; the purpose of the design is as follows: when the positioning element 2 is in a release state, the control element 22 is connected with the stent body 1 in a matching manner, so that the supporting force of the positioning element 2 can be increased, and the stability of the stent body 1 in the intracardiac position can be ensured.
In this embodiment, the control member 22 is disposed in a herringbone structure; one end of the control member 22 with a branch is connected to the positioning arm 21, and two connection points of the control member 22 on the positioning arm 21 are arranged in bilateral symmetry with the push-pull rod 221 as an axis, so that the stability of the connection structure can be ensured, and the deviation of a path can not occur; and the control member 22 is pulled more evenly by the positioning arm 21 during the drawing process, and the deformation generated during the drawing process is more stable.
In this embodiment, the positioning arm 21 is made of a shape memory material, and the preset shape of the positioning arm 21 is "U" shape, "V" shape or "W" shape; in a preferred embodiment, the positioning arm 21 is configured as a "U" shaped structure, and the circular arc segment of the "U" shape is positioned in the sinus after the positioning arm 21 is released.
In some preferred embodiments, as shown in fig. 4g, the surface of the positioning arm 21 is provided with barbs, or the surface of the positioning arm 21 is coated with a film, the barbs are made of a metal memory material, and after the positioning arm 21 recovers to a preset shape, the barbs can increase friction force on the endocardial tissue, so that the situation that the stent body 1 falls off in the heart can be effectively avoided.
In some embodiments, the surface of the stent body 1 is covered with a film, and the film material comprises a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron or animal-derived material.
The working process and working principle of the embodiment are as follows:
firstly, the heart valve prosthesis is deformed by pulling the control part 22, the positioning arm 21 is pulled to a set position (namely, the set position when the free end 212 of the positioning arm 21 is not overlapped with the stent body 1), then the heart valve prosthesis is compressed in the delivery sheath 4, one end of the control part 22 is in fit connection with the delivery sheath 4, so that the positioning arm 21 is kept at the set position, and the heart valve prosthesis is in a limiting state; (ii) a When the heart valve prosthesis is delivered and needed to be released by the delivery sheath 4, the control member 22 is released and one end of the control member 22 is pushed to enable the free end 212 of the positioning arm 21 to overlap with the stent body 1 until the positioning arm 21 returns to the preset shape, the locking structure 222 at one end of the control member 22 is connected in the fixing hole 11 in a matching manner, a certain supporting force is brought to the positioning arm 21 while the positioning arm 21 is fixed, at this time, the free end 212 of the positioning arm 21 is positioned at the target position where the heart valve prosthesis is needed, and then the stent body 1 and the prosthetic valve 3 are released, and the implantation of the heart valve prosthesis is completed (as shown in fig. 4a-4 f).
The second embodiment is as follows:
in order to better illustrate the working principle of the present invention, the process of releasing the prosthesis of the prosthetic valve 3 according to the present invention will be described step by step as follows:
as shown in fig. 7, when the heart valve prosthesis is used for treating aortic valve diseases, as shown in the figure, the heart valve prosthesis comprises a stent body 1, a positioning member 2 and a prosthetic valve 3, the prosthetic valve 3 is connected to the stent body 1, the positioning member 2 comprises a positioning arm 21 and a control member 22, one end of the control member 22 is connected to the positioning arm 21 in a matching manner, the positioning arm 21 has a fixed end 211 and a free end 212, the fixed end 211 is fixedly connected to the stent body 1, when the control member 22 pulls the positioning arm 21, the free end 212 of the positioning arm 21 moves along the height direction of the stent body 1, and when the positioning member 2 is in a release state, the positioning arm 21 returns to a preset shape; when the positioning element 2 is in the limited state, the free end 212 of the positioning arm 21 is not overlapped with the stent body 1, so that the tube diameter of the sheath tube for loading the valve can be greatly reduced, the replacement operation of the transvascular path can be realized for the patient, the wound to the patient is greatly reduced, and the postoperative recovery of the patient is facilitated (as shown in fig. 8a-8 c).
In this embodiment, the number of the positioning members 2 is 3, the positioning members 2 are located at the sinus floor of the natural aortic sinus of the patient after being released, and the positioning members 2 provide a certain supporting force for the stent body 1 in the heart, so that the stent body 1 is prevented from being flushed away by intracardiac blood while the stent body 1 is ensured to be safely and accurately released/implanted to a target position.
In some embodiments, the positioning arm 21 includes a retaining section 213 and an elastically deformable section 214, the retaining section 213 being located at the free end 212 of the positioning arm 21, and the elastically deformable section 214 being located between the retaining section 213 and the fixed end 211 of the positioning arm 21.
In some embodiments, the elastically deformable section 214 is flexible relative to the retaining section 213, and when the positioning element 2 is transformed from the restraining state to the releasing state, the elastically deformable section 214 deforms until it returns to the preset shape.
In another embodiment, the control member 22 is a wire or a thread, the control member 22 is detachably connected to the positioning arm 21, and when the positioning member 2 is in the release state, the control member 22 is separated from the positioning arm 21, so that the positioning arm 21 returns to the preset shape.
In some preferred embodiments, the control member 22 can be a single strand or wire or a plurality of strands or wires, and the end of the control member 22 connected to the positioning arm 21 is detachably connected, so that the design aims to greatly reduce the number of implants, reduce the contact and stimulation to the heart and the heart tissue and facilitate the postoperative recovery of the patient.
In some embodiments, the positioning arm 21 is made of a shape memory material, and the predetermined shape of the positioning arm 21 is a "U" shape, a "V" shape, or a "W" shape.
In some embodiments, the positioning arm 21 surface is provided with the barb, perhaps the positioning arm 21 surface is the tectorial membrane, the barb is made for metal memory material, and positioning arm 21 is after resumeing preset shape, and the barb can increase the frictional force to the intracardiac tissue, can effectively avoid the condition that stake body 1 drops in the heart.
In some embodiments, the surface of the stent body 1 is covered with a film, and the film material comprises a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron or animal-derived material.
The working process and working principle of the embodiment are as follows:
firstly, the heart valve prosthesis is deformed by pulling the control part 22, the positioning arm 21 is pulled to a set position (namely, the set position when the free end 212 of the positioning arm 21 is not overlapped with the stent body 1), then the heart valve prosthesis is compressed in the delivery sheath 4, one end of the control part 22 is in fit connection with the delivery sheath 4, so that the positioning arm 21 is kept at the set position, and the heart valve prosthesis is in a limiting state; (ii) a When the heart valve prosthesis is delivered and needed to be released by the delivery sheath 4, the control member 22 is released to separate the control member 22 from one end connected with the positioning arm 21, and since the positioning arm 21 is made of the shape memory material, the positioning arm 21 will recover to the preset shape by using the characteristics of the material of itself along with the separation from the control member 22, and then the free end 212 of the positioning arm 21 is positioned at the target position where we need to, and then the stent body 1 and the prosthetic valve 3 are released to complete the implantation of the heart valve prosthesis (as shown in fig. 9a-9 d).
The technique of the present invention is applicable to patients with mitral or tricuspid valve lesions, in addition to aortic valves.
Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (13)
1. The utility model provides a valve prosthesis with variable setting element, its characterized in that, includes stake body, setting element and artificial valve, artificial valve is connected on the stake body, the setting element includes registration arm and control, the one end cooperation of control is connected on the registration arm, the registration arm has stiff end and free end, stiff end and stake body fixed connection work as the control pulling during the registration arm, the free end of registration arm removes along the direction of height of stake body, when unclamping during the control, the registration arm progressively resumes for predetermineeing the shape.
2. The valve prosthesis with the variable positioning element of claim 1, wherein the positioning arm comprises a retaining section at a free end of the positioning arm and an elastically deformable section between the retaining section and a fixed end of the positioning arm.
3. The valve prosthesis with the variable positioning element according to claim 2, wherein the elastically deformable section is flexible relative to the retaining section, and deforms until returning to a predetermined shape when the positioning element is transformed from the restraining state to the releasing state.
4. The valve prosthesis with variable positioning element according to claim 1, wherein the control member comprises a push-pull rod having one end cooperatively connected with the positioning arm and a locking structure disposed at the other end of the push-pull rod.
5. The valve prosthesis with the variable positioning part according to claim 4, wherein the stent body is provided with a fixing hole corresponding to the locking structure, and when the control member is released, the locking structure is connected with the fixing hole in a matching manner.
6. The valve prosthesis with the variable positioning element according to claim 5, wherein the locking structure is a plurality of protrusions uniformly and symmetrically arranged on the left and right sides of the push-pull rod.
7. The valve prosthesis with variable positioning element of claim 1, wherein the control element is made of a shape memory material.
8. The valve prosthesis with the variable positioning element according to claim 1, wherein the positioning arms are made of shape memory material, and the preset shape of the positioning arms is a "U" shape, a "V" shape or a "W" shape.
9. The valve prosthesis with the variable positioning element according to claim 1, wherein the control element is arranged in a herringbone structure.
10. A valve prosthesis system with a variable positioning part is characterized by comprising a valve prosthesis with a positioning part, a control handle, an outer sheath and a controllable release device, wherein the valve prosthesis with the positioning part comprises a support body, a prosthetic valve and a positioning part, the prosthetic valve and the positioning part are connected to the support body in a matched mode, the support body is connected with the controllable release device in a matched mode, the positioning part comprises a positioning arm and a control part, one end of the control part is detachably connected with the positioning arm, the other end of the control part is connected with the control handle in a matched mode, the positioning arm is provided with a fixed end and a free end, the fixed end is fixedly connected with the support body, when the control part is pulled axially by operating the control handle, the free end of the positioning arm moves along the height direction of the support body, and the positioning arm is gradually retracted into a gap between the support body and the outer sheath, until the elastic adaptive area and the partial bracket where the artificial valve is located are not overlapped, the positioning arm is in a limiting state; when the control handle is operated reversely, the positioning arm gradually returns to the preset shape, the positioning arm gradually extends out of a gap between the bracket body and the outer sheath and returns to the preset shape, and at the moment, the positioning arm is in a release state.
11. The valve prosthesis system with variable positioning element of claim 10, wherein said positioning arm is capable of transitioning between said constrained state and said released state a plurality of times before said stent body is not completely disengaged from said controllable release device.
12. The valve prosthesis system with variable positioning element of claim 10, wherein the controllable release means comprises a distal release means and a proximal release means, the distal release means being located at a distal portion of the valve prosthesis system, the distal portion of the stent body being disposed in a collapsed state within the distal release means prior to being fully disengaged from the distal release means.
13. The valve prosthesis system with variable positioning element according to claim 12, wherein the proximal release device is disposed within the outer sheath and is adapted to be removably coupled to the proximal end of the stent body, and the proximal portion of the stent body is restrained from release by the proximal release device until the positioning element and the distal portion of the stent body are not fully released.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010692576.4A CN113440308A (en) | 2020-07-17 | 2020-07-17 | Valve prosthesis with variable positioning part and conveying system thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010692576.4A CN113440308A (en) | 2020-07-17 | 2020-07-17 | Valve prosthesis with variable positioning part and conveying system thereof |
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| CN113440308A true CN113440308A (en) | 2021-09-28 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115670750A (en) * | 2022-03-28 | 2023-02-03 | 科凯(南通)生命科学有限公司 | Easy-to-control aortic regurgitation stent |
| WO2023206645A1 (en) * | 2022-04-25 | 2023-11-02 | 金仕生物科技（常熟）有限公司 | Valve delivery system |
-
2020
- 2020-07-17 CN CN202010692576.4A patent/CN113440308A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115670750A (en) * | 2022-03-28 | 2023-02-03 | 科凯(南通)生命科学有限公司 | Easy-to-control aortic regurgitation stent |
| CN115670750B (en) * | 2022-03-28 | 2023-11-17 | 科凯(南通)生命科学有限公司 | Easy-to-control aortic regurgitation stent |
| WO2023206645A1 (en) * | 2022-04-25 | 2023-11-02 | 金仕生物科技（常熟）有限公司 | Valve delivery system |
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Address after: Building 5, area B, 777 Binhai Fourth Road, Hangzhou Bay New District, Ningbo City, Zhejiang Province, 315336 Applicant after: Ningbo Jianshi Technology Co.,Ltd. Address before: Building 5, area B, 777 Binhai Fourth Road, Hangzhou Bay New District, Ningbo City, Zhejiang Province, 315336 Applicant before: NINGBO JENSCARE BIOTECHNOLOGY Co.,Ltd. |