CN116236322B - Heart valve delivery system - Google Patents
Heart valve delivery system Download PDFInfo
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- CN116236322B CN116236322B CN202310520606.7A CN202310520606A CN116236322B CN 116236322 B CN116236322 B CN 116236322B CN 202310520606 A CN202310520606 A CN 202310520606A CN 116236322 B CN116236322 B CN 116236322B
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- frame body
- distal end
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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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
-
- 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
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention relates to a heart valve conveying system, which comprises an outer sheath tube, an inner sheath tube, a prosthetic valve and a guide wire, wherein the inner diameter of the distal end part of the inner sheath tube is larger than the inner diameters of other positions, and the prosthetic valve is arranged in the distal end part to form a combination; the prosthetic valve includes a stent; the bracket comprises a valve frame body and a plurality of hanging heads, the hanging heads are fixedly connected to the proximal end of the valve frame body, hanging points of the hanging heads are on the same hanging plane, and the hanging plane has a preset angle relative to a reference plane perpendicular to the axis of the valve frame body; a prosthetic valve disposed within the distal portion; the inner sheath tube is not provided with an adjustable bent steel tube; a plurality of hangers are arranged in the distal end part of the inner sheath tube, the number of the hangers is equal to that of the hangers, and the hangers are connected in one-to-one correspondence, so that the distal end of the combination body is bent to set an angle. The remote bending set angle of the combined body is realized by controlling the structure of the bracket, so that the cost of the heart valve conveying system is reduced on the premise that the artificial valve smoothly passes through the aortic arch, and the popularization of interventional operation is facilitated.
Description
Technical Field
The invention belongs to the technical field of medical treatment, and particularly relates to a heart valve conveying system.
Background
Heart valve disease is a common human disease, and as the population ages and aggravates, senile valvular disease and valvular lesions caused by coronary heart disease and myocardial infarction are also more and more common. Usually, the treatment of heart valve diseases mainly depends on surgical operation and interventional treatment technology, and the treatment mode is selected by comprehensively considering age, symptoms and cardiac function conditions of patients, complications, anatomical characteristics, experience of operators, life expectancy of patients, expectancy of postoperative life and other factors.
The existing interventional operation generally adopts a heart valve conveying system to convey a prosthetic heart valve into an aortic root to replace a diseased valve, the heart valve conveying system is used for conveying the prosthetic valve, the prosthetic valve is required to pass through an aortic arch, the aortic arch has large bending degree, an inner sheath tube for conveying the prosthetic valve can be controlled to bend for conveniently passing through the aortic arch, an adjustable bending steel tube is usually arranged in the inner sheath tube in the prior art, a doctor can control a traction wire at the proximal end to change the bending degree of the distal end of the inner sheath tube, and thus the heart valve can pass through the aortic arch and reach the aortic root, and the operation is completed.
However, the preparation difficulty of the inner sheath tube is high, and the yield is low, so that the cost of the heart valve conveying system is high, the cost of the interventional operation is increased, and the popularization of the interventional operation is influenced.
Disclosure of Invention
In view of the above, the invention provides a heart valve delivery system, wherein an adjustable bent steel tube is not arranged in an inner sheath tube, the distal end of a combination body is bent to a set angle by controlling the structure of a bracket, and the cost of the heart valve delivery system is reduced on the premise that a prosthetic valve smoothly passes through an aortic arch, so that the popularization of interventional operations is facilitated.
The invention adopts the technical scheme that:
a heart valve delivery system comprising an outer sheath, an inner sheath, a prosthetic valve and a guidewire, the inner diameter of the distal portion of the inner sheath being larger than the inner diameter of the other locations, the prosthetic valve being disposed within the distal portion to form a combination;
the guide wire passes through the interior of the combination, which passes through the interior of the outer sheath;
the artificial valve comprises a bracket and a valve coated on the bracket; the bracket comprises a valve frame body and a plurality of hanging heads, wherein the hanging heads are fixedly connected to the proximal end of the valve frame body, and the hanging heads are uniformly distributed in the circumferential direction of the valve frame body; the hanging points of the hanging heads are on the same hanging plane, and the hanging plane has a preset angle relative to a reference plane perpendicular to the axis of the valve frame body; the prosthetic valve has a contracted state and a deployed state, in which the radial dimension of the prosthetic valve is greater than its dimension in the contracted state, and in which the prosthetic valve is disposed within the distal end portion of the inner sheath;
the inner sheath tube is not internally provided with an adjustable bent steel tube; a plurality of hanging lugs are arranged in the distal end part of the inner sheath tube, the number of the hanging lugs is equal to that of the hanging heads, the hanging lugs are connected in a one-to-one correspondence manner, and the lengths of the hanging lugs are the same, so that the distal end of the combination body is bent for a set angle; the set angle is 5-30 degrees.
Preferably, the valve frame body comprises a plurality of waveform units with the same structure, the waveform units are connected in a ring shape in the circumferential direction, and the proximal end positions and the distal end positions of the waveform units are consistent in the axial direction, so that the proximal end face of the valve frame is perpendicular to the axis of the valve frame;
the number of the hanging heads is equal to that of the waveform units and corresponds to that of the waveform units one by one, the hanging heads comprise a first hanging head, a second hanging head and a plurality of third hanging heads, and among the hanging heads, the length of the first hanging head is longest, and the length of the second hanging head is shortest; in the radial direction of the valve frame, the first hanging heads and the second hanging heads are arranged oppositely, in the circumferential direction of the valve frame, the length of each third hanging head is gradually increased in the direction from the second hanging head to the first hanging head, so that a preset angle is formed between the hanging plane and the reference plane, and when the valve frame body is in a tightening state, the preset angle is equal to the set angle.
Preferably, the length of each of the hanging heads is in an arithmetic series in the circumferential direction from the second hanging head to the first hanging head.
Preferably, each of the hanging heads is bent towards the radial inner side of the bracket, and the bending angles of the hanging heads are consistent.
Preferably, the plurality of hangers includes a calibration hanger, the calibration hanger is connected with the second hanging head, and in the circumferential direction, other hangers are sequentially connected with other hanging heads.
Preferably, the device further comprises an operation handle, wherein a first positioning mark is arranged at the proximal end of the inner sheath, a second positioning mark is arranged on the operation handle, the proximal end of the inner sheath is connected with the operation handle, and the first positioning mark is aligned with the second positioning mark.
Preferably, the hanging head comprises a hanging rod and hooks connected with the hanging rod, and the openings of the hooks are consistent in the circumferential direction.
Preferably, the valve frame body comprises a first section, a second section and a third section from far to near in the axial direction of the valve frame body, and the diameters of the first section and the second section are smaller than the diameter of the third section.
Preferably, in the deployed state of the prosthetic valve,
when the radial dimension of the artificial valve is 20mm-25mm, the set angle is 5-13 degrees;
when the radial dimension of the artificial valve is 23mm-27.3mm, the set angle is 8-22 degrees;
the set angle is 15-30 degrees when the radial dimension of the artificial valve is 26-32 mm.
Preferably, the valve comprises a leaflet located inside the stent and a skirt that is wrapped outside the stent, the leaflet being connected to the skirt beyond the distal end of the stent.
The invention has the beneficial effects that:
during interventional operation, the artificial valve is first set in the distal end of the inner sheath to form the assembly, and then the assembly is fed to the aortic root along the guide wire, during which the distal end of the outer sheath reaches the descending aorta, and the distal end of the assembly passes through the outer sheath. Because the adjustable bent steel tube is not arranged in the inner sheath tube, the manufacturing cost of the inner sheath tube is reduced, the cost of the whole heart valve conveying system is reduced, and the operation burden of a patient is lightened; in the whole operation process, a doctor does not need to control the bending of the inner sheath, so that the interventional operation is conveniently and smoothly performed, and the operation effect is improved.
Drawings
The above and other objects, features and advantages of the present invention will become more apparent from the following description of embodiments of the present invention with reference to the accompanying drawings, in which:
FIG. 1 is a schematic view of a prosthetic valve through an aortic arch;
FIG. 2 is a schematic structural view of a bracket;
fig. 3 is a schematic illustration of the attachment of the prosthetic valve to the suspension loops in a contracted state.
In the figure: 1. aortic arch; 2. descending aorta; 3. an inner sheath; 4. a prosthetic valve; 5. a combination body; 6. a guide wire;
31. hanging lugs;
41. a third section; 42. a second section; 43. a first section; 44. a valve frame body; 45. a waveform unit; 46. a hanging rod; 47. a hook; 48. and (5) hanging the head.
Detailed Description
The present invention is described below based on examples, but the present invention is not limited to only these examples. In the following detailed description of the present invention, certain specific details are set forth in order to avoid obscuring the present invention, and in order to avoid obscuring the present invention, well-known methods, procedures, flows, and components are not presented in detail.
Moreover, those of ordinary skill in the art will appreciate that the drawings are provided herein for illustrative purposes and that the drawings are not necessarily drawn to scale.
Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, it is the meaning of "including but not limited to".
In the description of the present invention, it should be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Furthermore, in the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.
Taking an interventional operation as an example, the end near the ventricle is the "distal end" and the end near the doctor (operator) is the "proximal end".
Referring to fig. 1-3, the present invention provides a heart valve delivery system comprising an outer sheath, an inner sheath 3, a prosthetic valve 4, and a guidewire 6, wherein the inner diameter of the distal portion of the inner sheath 3 is larger than the inner diameter of the other locations, and the prosthetic valve 4 is disposed within the distal portion to form a combination 5.
The guide wire 6 passes through the inside of the combination 5, and the combination 5 passes through the inside of the outer sheath;
the artificial valve 4 comprises a bracket and a valve coated on the bracket; the bracket comprises a valve frame body 44 and a plurality of hanging heads 48, wherein the hanging heads 48 are fixedly connected to the proximal end of the valve frame body 44, and the hanging heads 48 are uniformly distributed in the circumferential direction of the valve frame body 44; the hanging points of the hanging heads 48 are on the same hanging plane, and the hanging plane has a preset angle relative to a reference plane perpendicular to the valve frame body 44; the prosthetic valve 4 has a contracted state and a deployed state in which the radial dimension of the prosthetic valve 4 is greater than its dimension in the contracted state, and in which the prosthetic valve 4 is disposed within the distal end portion of the inner sheath.
An adjustable bent steel tube is not arranged in the inner sheath tube 3; a plurality of hanging lugs 31 are arranged in the distal end part of the inner sheath tube 3, the number of the hanging lugs 31 is equal to that of the hanging heads 48, the hanging lugs 31 are connected in a one-to-one correspondence manner, and the lengths of the hanging lugs 31 are the same, so that the distal end of the combination body 5 is bent for a set angle; the set angle is 5 ° -30 °, for example 5 °, 10 °, 15 °, 20 °, 25 °, 30 °, etc.
When interventional operation is performed, the outer sheath tube is firstly extended into the aorta of a patient, the distal end of the outer sheath tube reaches the descending aorta 2, then the guide wire 6 is extended into the aorta, the distal end of the guide wire 6 is enabled to enter the ventricle, then the combined body 5 penetrates into the aorta along the guide wire 6, the distal end of the combined body 5 firstly passes through the outer sheath tube, the bending angle of the distal end of the combined body 5 is reduced (far smaller than the set angle) due to the limiting effect of the outer sheath tube on the distal end of the combined body 5, the distal end of the combined body 5 can smoothly reach the descending aorta 2 along the outer sheath tube, when the distal end of the combined body 5 penetrates out of the descending aorta 2, the distal end of the combined body 5 is not limited by the outer sheath tube, so that the combined body 5 returns to the set angle, the distal end of the combined body 5 can smoothly pass through the descending aorta 2 due to the large and straight inner diameter of the descending aorta 2, when the distal end of the combined body 5 reaches the aortic valve 1, the root of the combined body 5 bends, the bending angle of the distal end of the combined body 5 can smoothly reach the descending aorta 1, and the combined body can smoothly reach the aortic valve 1, and the artificial valve can be replaced by the artificial valve 1.
In the above process, when the distal end of the combination body 5 passes through the aortic arch 1, a doctor does not need to control the bending degree of the inner sheath tube 3, and the distal end of the combination body 5 can easily pass through the aortic arch 1, so that the situation that the doctor stabs the inner wall of the aorta due to accidental operation is avoided, the operation difficulty of the interventional operation is reduced, and the smooth proceeding of the interventional operation is ensured.
In the present invention, the entire stent is made of a memory metal such as nickel titanium alloy so that the valve frame body 44 is maintained in a specific state when not restricted, specifically, the valve frame body 44 (stent) has a contracted state and an expanded state, and when the prosthetic valve 4 is disposed in the distal end portion of the inner sheath 3, the valve frame body 44 is in the contracted state due to restriction of the distal end of the inner sheath 3, and the valve frame body 44 is in the contracted state, so that the radial dimension of the entire prosthetic valve 4 is small to facilitate its transfer in the aorta, and when reaching the aortic root, the prosthetic valve 4 is pushed out of the distal end portion of the inner sheath 3 while the valve frame body 44 is not restricted in the radial direction, so that it can be changed to the expanded state to be fixed to the aortic root to replace the diseased valve.
In the tightened state, each hanging point is located on the same hanging plane, and the hanging plane has a preset angle relative to the reference plane, when the prosthetic valve 4 is arranged in the distal end portion of the sheath tube, the hanging lugs 31 in the inner sheath tube 3 are connected with each hanging head 48, the connection points of the hanging heads 48 and the hanging lugs 31 are located at the hanging points, the lengths of the hanging lugs 31 are the same, so that when the hanging lugs 31 are connected with the hanging heads 48, the hanging plane is exactly perpendicular to the axis of the inner sheath tube 3, the hanging plane has a preset angle relative to the reference plane, the reference plane is perpendicular to the axis of the valve holder body 44 (also the axis of the prosthetic valve 4), namely, an included angle exists between the axis of the prosthetic valve 4 and the axis of the inner sheath tube 3, and the included angle is a preset angle, and therefore the distal end of the combination body 5 is bent to set an angle (preset angle).
It should be emphasized that no bendable steel tube is provided in the inner sheath 3 of the present invention, that is, during the whole operation, the doctor cannot control the inner sheath 3 to bend, and instead, by providing a special stent, the distal end of the combination 5 is naturally bent to a set angle to match the bending of the aortic arch 1 when the artificial valve 4 is disposed at the distal end of the inner sheath 3 to form the combination 5, so that the distal end of the combination 5 can easily pass through the aortic arch 1 without controlling the bending of the inner sheath 3.
As can be seen from the foregoing, the set angle is the same as the preset angle, so that the corresponding prosthetic valve 4 can be selected according to the actual situation (the bending situation of the aortic arch 1) such that the angle at which the distal end of the combination 5 is actually bent matches the bending situation of the aortic arch 1.
The valve frame body 44 comprises a plurality of waveform units 45 with the same structure, the waveform units 45 are connected in a ring shape in the circumferential direction, and the proximal end positions and the distal end positions of the waveform units 45 are consistent in the axial direction, so that the proximal end face of the valve frame is perpendicular to the axis of the valve frame;
the number of the hanging heads 48 is equal to that of the waveform units 45 and corresponds to that of the waveform units one by one, the hanging heads 48 comprise a first hanging head 48, a second hanging head 48 and a plurality of third hanging heads 48, and among the hanging heads 48, the first hanging head 48 is longest and the second hanging head 48 is shortest; in the radial direction of the petal rack, the first hanging heads 48 are opposite to the second hanging heads 48, and in the circumferential direction of the petal rack, the length of each third hanging head 48 gradually increases from the second hanging head 48 to the first hanging head 48, so that a preset angle is formed between the hanging plane and the reference plane, and when the petal rack body 44 is in a tightened state, the preset angle is equal to the set angle.
In the present invention, by controlling the length of the hanging head 48, a preset angle is formed between the hanging plane and the reference plane, specifically, the larger the difference between the lengths of the first hanging head 48 and the second hanging head 48 is, the larger the preset angle is, so that by controlling the lengths of the first hanging head 48 and the second hanging head 48, the desired preset angle can be adjusted to meet the actual requirement.
These third hooks 48, which are axially between the first hooks 48 and the second hooks 48, are intended to form a desired hooking plane, improving the effectiveness and stability of the connection between the plurality of hooks 48 and the plurality of lugs 31.
Of course, in other embodiments, the distal end positions of the waveform units 45 are consistent, a predetermined angle is formed between the plane of the proximal end and the reference plane, and the lengths of the hanging heads 48 are equal, so that the hanging plane of the hanging point on each hanging head 48 is parallel to the plane of the proximal end, and thus a predetermined angle is formed between the hanging plane and the reference plane.
In the circumferential direction, the length of each of the hanging heads 48 is in an arithmetic progression from the second hanging head 48 to the first hanging head 48. So that the hanging plane can form a preset angle with the reference plane.
Each of the hanging heads 48 is bent towards the radial inner side of the bracket, and the bending angles of the hanging heads 48 are consistent. The hanging lugs 31 are rigid, when the artificial valve 4 is unfolded, the hanging lugs 31 are connected with the hanging heads 48, at the moment, the hanging lugs 31 are in a conical shape, the hanging heads 48 are bent towards the radial inner side of the diameter, so that the cone apex angle of the conical shape is matched with the bending angle of the hanging heads 48, the reliability of connection of the hanging lugs and the hanging heads is improved in the state, and the artificial valve 4 is prevented from being released after the artificial valve 4 is not conveyed in place, so that medical accidents are caused; in the invention, if the release position of the artificial valve 4 is wrong, the hanging head 48 is still connected with the hanging lugs 31, so that the artificial valve 4 can be recovered, thereby avoiding the occurrence of medical accidents and improving the safety of the operation.
Preferably, a plurality of the lugs 31 includes one calibration lug 31, the calibration lug 31 is connected to the second hanging head 48, and the other lugs 31 are sequentially connected to the other hanging heads 48 in the circumferential direction.
Since the lengths of the hanging lugs 31 are the same, the first hanging head 48 on the artificial valve 4 can be connected with any hanging lug 31 in theory, so that the bending direction of the distal end of the combination body 5 can be bent towards any direction in the radial direction, the bending direction of the distal end of the combination body 5 can be consistent with the bending direction of the aortic arch 1, and the distal end of the combination body 5 can possibly stab the vessel wall during operation. According to the invention, one of the hanging lugs 31 is set as the calibration hanging lug 31 so as to be distinguished from the other hanging lugs 31, so that when the combined body 5 is assembled and formed, the calibration hanging lug 31 is connected with the first hanging head 48 with the longest length, and the artificial valve 4 can only be arranged in the distal end part in a unique installation mode, so that when the distal end of the combined body 5 reaches the aortic arch 1, the bending direction of the distal end of the combined body 5 is consistent with the bending direction of the aortic arch 1, thereby ensuring that the interventional operation is safely performed and ensuring the smoothness of the operation.
Further, the delivery system further comprises an operation handle, a first positioning mark is arranged at the proximal end of the inner sheath tube 3, a second positioning mark is arranged on the operation handle, the proximal end of the inner sheath tube 3 is connected with the operation handle, and the first positioning mark is aligned with the second positioning mark. The first positioning mark and the second positioning mark are arranged so that the inner sheath 3 is connected with the operation handle at a unique angle in the circumferential direction, and when the distal end of the combination body 5 reaches the aortic arch 1, the bending direction of the combination body 5 is consistent with the bending direction of the aortic arch 1.
The hanging head 48 includes a hanging rod 46 and hooks 47 connected to the hanging rod 46, and openings of the hooks 47 are aligned in the circumferential direction. When the hanging lugs 31 are connected with the hanging heads 48, the hanging lugs 31 are connected with the hanging hooks 47, the opening directions of the hanging hooks 47 are consistent, and the hanging lugs 31 are conveniently separated from the hanging heads 48 after the artificial valve 4 is unfolded.
In the axial direction of the valve frame body 44, from far to near, the valve frame body 44 includes a first section 43, a second section 42, and a third section 41, and the diameters of the first section 43 and the second section 42 are smaller than the diameter of the third section 41. The diameter of the first section 43 may be equal to or different from the diameter of the second section 42, and the diameter of the third section 41 is larger, so that the expanded prosthetic valve 4 is in a reverse cone shape, the prosthetic valve 4 is conveniently fixed to the root of the aorta, and the occurrence of high and low shoulders can be prevented, thereby ensuring the smooth performance of the interventional operation.
In one embodiment, the first section 43 corresponds to a first grid part, the second section 42 corresponds to a second grid part, the third section 41 corresponds to a third grid part, the first grid part is surrounded by the first grids, the number of the first grids is 9-18, the second grid part is surrounded by the second grids, the number of the second grids is 9-18, the third grid part is surrounded by the third grids, and the number of the third grids is 9-18. The first grid and the second grid are quadrilateral grids formed by surrounding four waveform rods, and the third grid is hexagonal grid formed by surrounding four waveform rods and two straight rods. The diameter of the first mesh part is 18-35mm as the diameter of the second mesh part, the diameter of the third mesh part is 2-5mm larger than the diameter of the second mesh part, and the valve frame body 44 is characterized by a bottle stopper type inverted truncated cone, so that most patients with aortic valve stenosis are often accompanied by uneven calcification of the part above the valve annulus, and the valve frame with the bottle stopper type inverted truncated cone can push away the native calcification more effectively, can be firmly implanted into the root of the aorta, prevent the artificial valve 4 from sliding towards the heart chamber, and ensure safety.
When the radial dimension of the artificial valve 4 is 20mm-25mm in the unfolded state of the artificial valve 4, the set angle is 5-13 degrees; when the radial dimension of the artificial valve 4 is 23mm-27.3mm, the set angle is 8-22 degrees; the set angle is 15 ° -30 ° when the radial dimension of the prosthetic valve 4 is 26mm-32 mm.
Due to the difference of patients, the specifications of the artificial valves 4 used by the patients are different, and the bending degree of the aortic arch 1 of the patients is also different, but the smaller the size of the artificial valve 4 is selected as a whole, the smaller the setting angle is, the invention divides according to the radial size of the artificial valve 4, and the setting angle is determined, so that the distal end of the combined body 5 can smoothly pass through the aortic arch 1.
The valve includes leaflets located inside the stent and a skirt that wraps around the outside of the stent, the leaflets being connected to the skirt beyond the distal end of the stent. In the unfolded state, the skirt edge is in contact with peripheral tissues, so that the occurrence of paravalvular leakage is prevented. The material of the valve leaflet is bovine pericardium, and the material of the skirt is polyethylene terephthalate.
It will be understood that the above-described embodiments are merely illustrative and not restrictive, and that all obvious or equivalent modifications and substitutions to the details given above may be made by those skilled in the art without departing from the underlying principles of the invention, are intended to be included within the scope of the appended claims.
Claims (8)
1. A heart valve delivery system comprising an outer sheath, an inner sheath, a prosthetic valve and a guidewire, wherein the inner diameter of the distal portion of the inner sheath is greater than the inner diameter of the other locations, and the prosthetic valve is disposed within the distal portion to form a combination;
the guide wire passes through the interior of the combination, which passes through the interior of the outer sheath;
the artificial valve comprises a bracket and a valve coated on the bracket; the bracket comprises a valve frame body and a plurality of hanging heads, wherein the hanging heads are fixedly connected to the proximal end of the valve frame body, and the hanging heads are uniformly distributed in the circumferential direction of the valve frame body; the hanging points of the hanging heads are on the same hanging plane, and the hanging plane has a preset angle relative to a reference plane perpendicular to the axis of the valve frame body; the prosthetic valve has a contracted state and a deployed state, in which the radial dimension of the prosthetic valve is greater than its dimension in the contracted state, and in which the prosthetic valve is disposed within the distal end portion of the inner sheath;
the inner sheath tube is not internally provided with an adjustable bent steel tube; a plurality of hanging lugs are arranged in the distal end part of the inner sheath tube, the number of the hanging lugs is equal to that of the hanging heads, the hanging lugs are connected in a one-to-one correspondence manner, and the lengths of the hanging lugs are the same, so that the distal end of the combination body is bent for a set angle; the set angle is 5-30 degrees;
the valve frame body comprises a plurality of waveform units with the same structure, the waveform units are connected in the circumferential direction to form a ring shape, and the proximal end positions and the distal end positions of the waveform units are consistent in the axial direction, so that the proximal end face of the valve frame body is perpendicular to the axis of the valve frame body;
the number of the hanging heads is equal to that of the waveform units and corresponds to that of the waveform units one by one, the hanging heads comprise a first hanging head, a second hanging head and a plurality of third hanging heads, and among the hanging heads, the length of the first hanging head is longest, and the length of the second hanging head is shortest; in the radial direction of the valve frame body, the first hanging heads and the second hanging heads are arranged oppositely, in the circumferential direction of the valve frame body, the length of each third hanging head gradually becomes larger from the second hanging heads to the first hanging heads, so that a preset angle is formed between the hanging plane and the reference plane, and when the valve frame body is in a tightening state, the preset angle is equal to the set angle.
2. The valve delivery system of claim 1, wherein a length of each of the hooks in the circumferential direction from the second hook to the first hook is in an arithmetic progression.
3. The valve delivery system of claim 1, wherein each of the hanging heads is bent toward a radially inner side of the stent, and wherein the bending angle of each of the hanging heads is uniform.
4. The valve delivery system of claim 1, wherein the plurality of hangers comprises a calibration hanger, the calibration hanger being connected to the second hanger, and the other hangers being connected in turn to the other hangers in a circumferential direction.
5. The valve delivery system of claim 4, further comprising an operating handle having a first positioning marker disposed on a proximal end of the inner sheath, a second positioning marker disposed on the operating handle, the proximal end of the inner sheath being coupled to the operating handle and the first positioning marker being aligned with the second positioning marker.
6. The valve delivery system of claim 1, wherein the hanging head comprises a hanging rod and a hanger connected to the hanging rod, the hanger opening facing in a uniform direction in the circumferential direction.
7. The valve delivery system of any one of claims 1-6, wherein the valve frame body comprises, from distal to proximal, a first segment, a second segment, and a third segment in an axial direction of the valve frame body, the first segment and the second segment each having a diameter that is less than a diameter of the third segment.
8. The valve delivery system of claim 1, wherein the valve comprises leaflets and a skirt, the leaflets being located on the inside of the stent, the skirt being wrapped around the outside of the stent, the leaflets being connected to the skirt beyond the distal end of the stent.
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| CN202310520606.7A CN116236322B (en) | 2023-05-10 | 2023-05-10 | Heart valve delivery system |
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| CN116236322A (en) | 2023-06-09 |
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