A fixation ring, an artificial heart valve stent system, and a release method thereof.

Abstract

The embodiment of the application provides a fixing ring, an artificial heart valve stent system and a releasing method, and belongs to the technical field of medical devices. The fixing ring comprises a body for fixing an artificial heart valve stent and a supporting part for contacting with heart tissue, the body defines a channel for the artificial heart valve stent to pass through, and the supporting part protrudes from the body and along the axial direction of the body. The fixing ring can enhance the anchoring stability of the artificial heart valve stent and reduce the probability of slipping.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a fixation ring, an artificial heart valve stent system, and a release method. Background Technology

[0002] The current principle of transcatheter aortic valve replacement (TAVR) is to accurately place a stent with a valve at the aortic root via a catheter delivery system, replacing the diseased aortic valve. The aortic root generally refers to the portion of the ascending aorta within the pericardial cavity, which is an extension of the left ventricular outflow tract. The upper part of the aortic root is the aortic canal, and the lower part is the aortic sinus; the junction of these two parts is the sinus-canal junction. Considering the height of the coronary artery ostia, and to minimize impact on the ostia of the left and right coronary arteries, the stent should be designed to be as short as possible, or the mesh size in the coronary artery ostia area should be increased. Simultaneously, the distance from the free edge of the sutured valve to the sinus floor should be less than the distance from the coronary artery ostia to the sinus floor, so that the valve can adhere to the aortic wall during cardiac systole, thus not affecting the coronary artery ostia.

[0003] Aortic valve disease mainly focuses on calcified aortic valves and valvular insufficiency. Transcatheter aortic valve products mainly include mechanically expandable stents, balloon expandable stents, and self-expanding stents. However, these active valve stents usually have some problems. For example, long active valve stents can easily obstruct the coronary arteries, while short active valve stents are prone to stent dislodgement. Therefore, the stability of active valve stents is particularly important. Summary of the Invention

[0004] This application provides a fixing ring, an artificial heart valve stent system, and a release method, which can enhance the anchoring stability of the artificial heart valve stent and reduce the probability of slippage.

[0005] In a first aspect, embodiments of this application provide a fixing ring for positioning an artificial heart valve stent. The fixing ring includes a body for fixing the artificial heart valve stent and a support portion for contacting heart tissue. The body defines a channel through which the artificial heart valve stent passes, and the support portion protrudes from the body.

[0006] In this design, the support portion within the fixing ring allows it to contact and position itself against the corresponding area of ​​the heart tissue, ensuring the ring is positioned at the target location (e.g., the original valve annulus). The fixing ring itself contains a channel through which an artificial heart valve stent can be inserted. For heart disease patients, especially those with valvular regurgitation, the artificial heart valve stent is prone to shifting towards the ventricle due to blood regurgitation. Positioning the fixing ring on the side of the heart tissue furthest from the ventricle effectively adds a reinforcement to the artificial heart valve stent, enhancing its anchoring stability at the original valve annulus and reducing the probability of slippage towards the ventricle.

[0007] In some embodiments, there are multiple supports, which are distributed circumferentially along the body and protrude toward the same side of the body axially.

[0008] In the above technical solution, by setting the number of support parts to multiple, and having multiple support parts protrude to the same side of the body axis, the cooperation of multiple support parts can increase the number of positioning contact points between the fixation ring and the heart tissue, thereby making the positioning stability of the fixation ring in the heart tissue higher and more reliable, and ensuring the reinforcement performance of the artificial heart valve stent.

[0009] In some embodiments, the body is formed by spiraling at least one wire around the channel.

[0010] In some embodiments, at least two of the plurality of supports are formed by bending the ends of the wire.

[0011] In the above technical solution, since the body is made of wire with two ends, at least two of the multiple support parts are formed by bending the ends of the wire, that is, at least two support parts are formed by bending the ends of the wire of the body itself. This ensures that at least two of the multiple support parts in the fixing ring are integrally formed with the body, the fixing ring has strong integrity, higher structural stability, and more reliable positioning with the heart tissue.

[0012] In some embodiments, the body includes a first helical segment and a second helical segment, and the number of support parts is three, namely a first support part, a second support part and a third support part; one end of the first support part is connected to the beginning end of the first helical segment, and the other end is a free end; one end of the second support part is connected to the end of the first helical segment, and the other end is connected to the beginning end of the second helical segment; one end of the third support part is connected to the end of the second helical segment, and the other end is a free end.

[0013] In the above technical solution, by including a first helical segment and a second helical segment, the body has at least a two-turn structure, resulting in strong structural stability and resistance to deformation. The number of support parts is set to three, with the first, second, and third support parts positioned at three points on the corresponding parts of the heart tissue, ensuring reliable positioning.

[0014] In some embodiments, a connecting portion for connection with a conveying system is provided at the free end of the first support portion.

[0015] In the above technical solution, a connecting part is provided at the free end of the first support part. The connecting part is used to connect with the delivery system so that the fixed ring can be delivered to the valve annulus of the heart tissue through the delivery system, thereby improving the stability and reliability of the fixed ring delivery process. In addition, the setting of the connecting part can also realize the recyclability of the fixed ring.

[0016] In some embodiments, the support portion is U-shaped.

[0017] In the above technical solution, by adopting a U-shaped support and an arc-shaped lower part, the part of the support that contacts the heart tissue will not have sharp corners, thus minimizing damage to the heart tissue and increasing safety.

[0018] In some embodiments, the body and the support are wound from the same wire.

[0019] In the above technical solution, by winding the body and the support part from the same wire, the overall integrity of the fixing ring is improved and the structure is simplified.

[0020] In some embodiments, the fixing ring is an aortic valve stent fixing ring, the channel is used for the aortic valve stent to pass through, the body is used to provide circumferential restraint to the aortic valve stent, and the support is used to contact and position with the aortic sinus.

[0021] Secondly, embodiments of this application provide an artificial heart valve stent system, which includes an artificial heart valve stent and the aforementioned fixing ring. The artificial heart valve stent is inserted into a channel of the body and fixed to the body.

[0022] In this design, the artificial heart valve stent is inserted into the channel of the body and fixed to the body. The setting of the fixing ring is equivalent to adding a reinforcement device to the artificial heart valve stent, which can enhance the anchoring stability of the artificial heart valve stent at the original valve annulus and reduce the probability of the artificial heart valve stent slipping off to the ventricle.

[0023] In some embodiments, the artificial heart valve stent is an aortic valve stent, the channel is for the aortic valve stent to pass through, and the support is for positioning in the aortic sinus.

[0024] In the above technical solution, the fixing ring is released at the aortic valve, and the support part of the fixing ring is positioned at the aortic sinus, so that the fixing ring is positioned at the aortic valve; the channel of the fixing ring is for the aortic valve stent to pass through, which is used to provide reinforcement function for the aortic valve stent, making the aortic valve stent anchorage performance of the aortic valve stronger and reducing the probability of aortic valve stent dislodgement.

[0025] In some embodiments, the inner diameter of the retaining ring is smaller than the outer diameter of the aortic valve stent, and the retaining ring is used to provide circumferential restraint to the aortic valve stent.

[0026] In the above technical solution, by making the inner diameter of the fixing ring smaller than the outer diameter of the aortic valve stent, after the aortic valve stent is inserted into the channel of the body, the fixing ring will hold the waist of the aortic valve stent tightly. The fixing ring can provide circumferential restraint force to the aortic valve stent, so that the fixing ring and the aortic valve stent are in a tight relationship, thereby achieving relative fixation between the fixing ring and the aortic valve stent.

[0027] Thirdly, embodiments of this application provide a method for releasing an artificial heart valve stent system, the method comprising the following steps: releasing a fixing ring to position the support portion; releasing the artificial heart valve stent so that the artificial heart valve stent passes through the channel of the fixing ring, so that the fixing ring provides circumferential constraint force to the artificial heart valve stent.

[0028] This innovative design incorporates a fixing ring for reinforcing artificial heart valve stents. Before the stent is released, the fixing ring is pre-released at a corresponding location in the heart tissue, positioning its support on the side of the heart tissue furthest from the ventricle. The artificial heart valve stent is then released, passing through the channel of the fixing ring. The fixing ring provides circumferential restraint to the stent, integrating it seamlessly with the stent. Because the fixing ring is anchored to the corresponding location in the heart tissue, the anchoring performance of the artificial heart valve stent at the heart tissue (e.g., the original valve annulus) is enhanced, reducing the probability of stent dislodgement.

[0029] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1 This is a schematic diagram of the structure of the fixing ring provided in some embodiments of this application;

[0032] Figure 2 A front view of a retaining ring provided in some embodiments of this application;

[0033] Figure 3 A schematic diagram illustrating the state in which the retaining ring is prepared to be retracted into the sheath according to some embodiments of this application;

[0034] Figure 4 This is a schematic diagram showing the state of the retaining ring after it has been retracted into the sheath, as provided in some embodiments of this application.

[0035] Figure 5 Schematic diagrams showing the state of the retaining ring after it has been retracted into the sheath, as provided in other embodiments of this application;

[0036] Figure 6 Schematic diagrams illustrating the state of the retaining ring during release, provided for some embodiments of this application;

[0037] Figure 7 This is a schematic diagram showing the state of the retaining ring after release, provided in some embodiments of this application.

[0038] Figure 8 This is a schematic diagram showing the state of an artificial heart valve stent system after deployment, as provided in some embodiments of this application.

[0039] Icons: 100-Fixing ring; 10-Body; 11-Channel; 12-First helical segment; 13-Second helical segment; 20-Supporting part; 21-First supporting part; 22-Second supporting part; 23-Third supporting part; 24-Connecting part; 200-Aortic valve stent; 201-Traction wire; 202-Sheath; 203-Delivery system handle; 300-Aortic valve. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0041] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0042] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0043] In the description of the embodiments of this application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on this application. In addition, the terms "first," "second," "third," etc. are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0044] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up" and "connected" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0045] Example

[0046] This application provides a fixing ring for positioning an artificial heart valve stent. (See also...) Figures 1 to 8 The fixing ring 100 includes a body 10 for fixing the artificial heart valve stent and a support portion 20 for contacting heart tissue. The body 10 defines a channel 11 through which the artificial heart valve stent passes, and the support portion 20 protrudes from the body 10.

[0047] In this design, the support portion 20 within the fixing ring 100 allows the fixing ring 100 to contact and be positioned with the corresponding part of the heart tissue (e.g., the original valve annulus), thus positioning the fixing ring 100 at the target location within the heart tissue. The main body 10 of the fixing ring 100 itself defines a channel 11 through which an artificial heart valve stent can be inserted. For heart disease patients, especially those with valvular regurgitation, the artificial heart valve stent is prone to shifting towards the ventricle due to blood regurgitation. Positioning the fixing ring 100 on the side of the heart tissue furthest from the ventricle effectively adds a reinforcing device to the artificial heart valve stent in patients with valvular regurgitation, enhancing the anchoring stability of the artificial heart valve stent at the original valve annulus and reducing the probability of the artificial heart valve stent slipping out towards the ventricle.

[0048] The heart tissue can be the mitral valve, tricuspid valve, aortic valve, or pulmonary valve. In this embodiment, the heart tissue is the aortic valve, so the support portion 20 is positioned in contact with the aortic sinus. In addition, the support portion 20 protrudes from the body 10, and the protrusion direction is along the axial direction and at a certain angle to the axial direction, that is, the protrusion direction of the support portion 20 has a certain tilt angle with the axial direction.

[0049] In some embodiments, there are multiple support portions 20, which are distributed circumferentially around the body 10 and protrude toward the same side of the body 10 in the axial direction. By setting the number of support portions 20 to multiple and having them protrude toward the same side of the body 10 in the axial direction, the multiple support portions 20 cooperate to increase the number of positioning contact points between the fixing ring 100 and the heart tissue, thereby making the positioning stability of the fixing ring 100 in the heart tissue higher and more reliable, ensuring the reinforcement performance of the artificial heart valve stent.

[0050] The number of support parts 20 can be two, three, or four, and the specific number can be determined according to the actual situation. In addition, the multiple support parts 20 can be evenly distributed in the circumference of the body 10. For example, when there are three support parts 20, the angle between two adjacent support parts 20 in the circumference of the body 10 is 120°.

[0051] In some embodiments, the body 10 is formed by spiraling at least one wire around the channel 11.

[0052] Understandably, the body 10 can be formed by spiraling a single wire around the channel 11, or by combining multiple wires to spiral around the channel 11. The number of wires can be determined according to the actual situation. The fewer the number of wires, the better the integrity of the body 10.

[0053] In addition, the main body 10 and the support part 20 can be an integrally formed structure, or the support part 20 and the main body 10 can be fixedly connected. Of course, some of the multiple support parts 20 can be integrally formed with the main body 10, while other support parts 20 can be fixedly connected with the main body 10.

[0054] For example, at least two of the plurality of support portions 20 are formed by bending the ends of the wire. Since the body 10 is made of wire wound with two ends, by forming at least two of the plurality of support portions 20 by bending the ends of the wire, that is, by bending the ends of the wire of the body 10 itself, it can be ensured that at least two of the plurality of support portions 20 in the fixing ring 100 are integrally formed with the body 10. The fixing ring 100 has strong integrity, higher structural stability, and more reliable positioning with the heart tissue.

[0055] The body 10 can be a single-layer spiral structure or a multi-layer spiral structure. For example, the number of turns in the body 10 can be 2 to 5. Figure 4 and Figure 5 The number of turns of the body 10 of the middle fixed ring 100 is different.

[0056] Optionally, please refer to Figure 1 and Figure 2 The body 10 includes a first helical segment 12 and a second helical segment 13, and three support parts 20: a first support part 21, a second support part 22, and a third support part 23. One end of the first support part 21 is connected to the beginning of the first helical segment 12, and the other end is free. One end of the second support part 22 is connected to the end of the first helical segment 12, and the other end is connected to the beginning of the second helical segment 13. One end of the third support part 23 is connected to the end of the second helical segment 13, and the other end is free. By including the first helical segment 12 and the second helical segment 13, the body 10 has at least a two-coil structure, resulting in strong structural stability and resistance to deformation. The three support parts 20 allow the first support part 21, the second support part 22, and the third support part 23 to be positioned securely at three points on the corresponding parts of the heart tissue.

[0057] Among them, such as Figure 6 As shown, when the artificial heart valve stent is the aortic valve stent 200, the fixing ring 100 is positioned on the aortic valve 300, and there are three support parts 20 in the fixing ring 100, namely the first support part 21, the second support part 22 and the third support part 23; there are three aortic sinuses, namely the left sinus, the right sinus and the posterior sinus, and the first support part 21, the second support part 22 and the third support part 23 are positioned on the left sinus, the right sinus and the posterior sinus respectively.

[0058] In some embodiments, such as Figure 1 As shown, a connecting part 24 for connecting to a delivery system is provided at the free end of the first support part 21. By providing the connecting part 24 at the free end of the first support part 21, the connecting part 24 is used to connect to the delivery system, so that the fixed ring 100 can be delivered to the valve annulus of the heart tissue through the delivery system, thereby improving the stability and reliability of the delivery process of the fixed ring 100; and the provision of the connecting part 24 also enables the fixed ring 100 to be retrievable.

[0059] The connecting part 24 is a ring structure, and its inner diameter can be 0.5–2 mm. Furthermore, the support part 20 can have various shapes, such as U-shaped, V-shaped, or triangular. The axial height of the support part 20 can be 3–20 mm.

[0060] For example, the support portion 20 is U-shaped. By adopting a U-shaped shape for the support portion 20, the lower part of the support portion 20 has an arc-shaped structure, and the part of the support portion 20 that contacts the heart tissue will not have sharp corner structures, resulting in less damage to the heart tissue and higher safety.

[0061] In some embodiments, such as Figure 4 and Figure 5 As shown, the body 10 and the support 20 are wound from the same wire. By making the body 10 and the support 20 from the same wire, the overall integrity of the fixing ring 100 is improved, the structure is simplified, and it is also beneficial for the conveying system to take the fixing ring 100 into the sheath.

[0062] The wire can be made of shape memory alloy; for example, in this embodiment, the wire is made of nickel-titanium alloy, and the diameter of a single filament can be 0.3–1.0 mm. The retaining ring 100 is inserted into the sheath of the conveying system as follows: Figure 4 and Figure 5 As shown.

[0063] For example, such as Figure 6 As shown, in the case of the heart tissue being the aortic valve 300, the fixing ring 100 is the aortic valve stent fixing ring 100, the channel 11 is used for the aortic valve stent 200 to pass through, the body 10 is used to provide circumferential restraint force to the aortic valve stent 200, and the support part 20 is used to contact and position with the aortic sinus.

[0064] This application provides an artificial heart valve stent system, which includes an artificial heart valve stent and a fixing ring 100. The artificial heart valve stent is inserted into the channel 11 of the body 10 and fixed to the body 10.

[0065] In this design, the artificial heart valve stent is inserted into the channel 11 of the body 10 and fixed to the body 10. The setting of the fixing ring 100 is equivalent to adding a reinforcement device to the artificial heart valve stent, which can enhance the anchoring stability of the artificial heart valve stent at the original valve annulus and reduce the probability of the artificial heart valve stent slipping off to the ventricle.

[0066] In some embodiments, the artificial heart valve stent is an aortic valve stent 200. A channel 11 is used for the aortic valve stent 200 to pass through, and a support portion 20 is used for positioning in the aortic sinus. A fixing ring 100 is released at the aortic valve 300, and the support portion 20 of the fixing ring 100 is positioned in the aortic sinus, thus positioning the fixing ring 100 at the aortic valve 300. The channel 11 of the fixing ring 100 allows the aortic valve stent 200 to pass through, providing reinforcement to the aortic valve stent 200, resulting in stronger anchoring performance of the aortic valve stent 200 in the aortic valve 300 and reducing the probability of the aortic valve stent 200 dislodging.

[0067] In some embodiments, the inner diameter of the retaining ring 100 is smaller than the outer diameter of the aortic valve stent 200, and the retaining ring 100 is used to provide circumferential restraint force to the aortic valve stent 200. By making the inner diameter of the retaining ring 100 smaller than the outer diameter of the aortic valve stent 200, after the aortic valve stent 200 passes through the channel 11 of the body 10, the retaining ring 100 holds the waist of the aortic valve stent 200 tightly, and the retaining ring 100 can provide circumferential restraint force to the aortic valve stent 200, so that the retaining ring 100 and the aortic valve stent 200 are in a tight relationship, thereby achieving relative fixation between the retaining ring 100 and the aortic valve stent 200.

[0068] This application provides a method for releasing an artificial heart valve stent system. Please refer to [link to relevant documentation]. Figures 6 to 8 Taking the aortic valve stent 200 as an example, the method includes the following steps: releasing the fixing ring 100 to position the support portion 20 in the aortic sinus; releasing the aortic valve stent 200 so that the aortic valve stent 200 passes through the channel 11 of the fixing ring 100, so that the fixing ring 100 provides circumferential constraint force to the aortic valve stent 200.

[0069] This innovative design reinforces the aortic valve stent 200 with a fixing ring 100. Before the aortic valve stent 200 is released, the fixing ring 100 is pre-released at the aortic valve 300, positioning the support portion 20 of the fixing ring 100 on the aortic sinus side of the aortic valve. Then, the aortic valve stent 200 is released, passing through the channel 11 of the fixing ring 100. The fixing ring 100 provides circumferential restraint to the aortic valve stent 200, making the fixing ring 100 and the aortic valve stent 200 a single unit. Because the fixing ring 100 is anchored to the aortic sinus of the aortic valve 300, the anchoring performance of the aortic valve stent 200 at the aortic valve 300 is enhanced, reducing the probability of the aortic valve stent 200 dislodging.

[0070] Specifically, there are two access methods for the fixation ring 100, which will be explained using the aortic valve stent 200 as an example. First, the fixation ring 100 is released first through the corresponding sheath of the delivery system via femoral or transcarotid puncture. After release, the sheath is withdrawn, and then the prosthetic valve delivery system is reinserted via a lead wire to release the aortic valve 300 membrane prosthesis. Second, an aortic valve prosthesis with a short length that does not obstruct the coronary artery effluent can be retrieved via femoral / transcarotid puncture and loaded into the delivery sheath 202. Simultaneously, the fixation ring 100 can be retrieved into the sheath 202 through a movable tube and pulled into the sheath 202 by the traction wire 201. During release, when the delivery sheath 202 reaches above the coronary artery effluent, the delivery system handle 203 is operated to push out the movable tube to release the fixation ring 100 first, and then release the aortic valve 300 membrane prosthesis. After releasing the fixation ring 100, a fixation device can be added to the aortic valve annulus of patients with valvular regurgitation, enhancing the anchoring function of the aortic valve stent 200 in the artificial heart valve prosthesis and reducing its slippage risk.

[0071] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0072] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A fixation ring for positioning a prosthetic heart valve stent, characterized by, The fixing ring comprises a body for fixing a prosthetic heart valve stent and support portions for contacting heart tissue, the body defines a passage for the prosthetic heart valve stent to pass through, and the support portions protrude from the body; the support portions are multiple, and the multiple support portions comprise a first support portion, one end of the first support portion is connected with the body, and the other end is a free end, the free end of the first support portion is provided with a connecting portion which can be connected with a delivery system, and the body and the support portions are formed by winding a same wire.

2. The stationary ring of claim 1, wherein The multiple support portions are spaced apart along the circumference of the body and protrude towards the same side of the body in the axial direction.

3. The stationary ring of claim 2, wherein, The body is formed by winding at least one wire around the passage in a spiral manner.

4. The stationary ring of claim 3, wherein, At least two of the multiple support portions are formed by bending the end of the wire.

5. The stationary ring of claim 4, wherein, The body comprises a first spiral segment and a second spiral segment, and the number of the support portions is three, which are the first support portion, the second support portion and the third support portion respectively. One end of the first support portion is connected with the leading end of the first spiral segment, and the other end is the free end; one end of the second support portion is connected with the trailing end of the first spiral segment, and the other end is connected with the leading end of the second spiral segment; one end of the third support portion is connected with the trailing end of the second spiral segment, and the other end is the free end.

6. The stationary ring of claim 1, wherein, The shape of the support portion is U-shaped.

7. The stationary ring of any one of claims 1-6, wherein, The fixing ring is a aortic valve stent fixing ring, the passage is used for the aortic valve stent to pass through, the body is used for providing a circumferential constraint force to the aortic valve stent, and the support portions are used for positioning in contact with the aortic sinus.

8. A prosthetic heart valve stent system, characterized in that, The fixing ring comprises a body for fixing a prosthetic heart valve stent and support portions for contacting heart tissue, the body defines a passage for the prosthetic heart valve stent to pass through, and the support portions protrude from the body; the support portions are multiple, and the multiple support portions comprise a first support portion, one end of the first support portion is connected with the body, and the other end is a free end, the free end of the first support portion is provided with a connecting portion which can be connected with a delivery system, and the body and the support portions are formed by winding a same wire.

9. The prosthetic heart valve support system of claim 8, wherein, The fixing ring is a aortic valve stent fixing ring, the passage is used for the aortic valve stent to pass through, the body is used for providing a circumferential constraint force to the aortic valve stent, and the support portions are used for positioning in contact with the aortic sinus.

10. The prosthetic heart valve support system of claim 9, wherein, The fixing ring comprises a body for fixing a prosthetic heart valve stent and support portions for contacting heart tissue, the body defines a passage for the prosthetic heart valve stent to pass through, and the support portions protrude from the body; the support portions are multiple, and the multiple support portions comprise a first support portion, one end of the first support portion is connected with the body, and the other end is a free end, the free end of the first support portion is provided with a connecting portion which can be connected with a delivery system, and the body and the support portions are formed by winding a same wire. The fixing ring is a aortic valve stent fixing ring, the passage is used for the aortic valve stent to pass through, the body is used for providing a circumferential constraint force to the aortic valve stent, and the support portions are used for positioning in contact with the aortic sinus.

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