Left ventricle outflow tract stent and delivery system

Abstract

A left ventricle outflow tract stent and a delivery system. The left ventricle outflow tract stent comprises a stent body, the stent body consisting of a plurality of support components arranged along a first path coinciding with the path of the left ventricle outflow tract. The support components comprise inverted V-shaped frames and inverted trapezoidal frames, the inverted V-shaped frames and the inverted trapezoidal frames being alternately arranged so as to form peak regions and valley regions, and connection strips being provided on the support components. The delivery system comprises a control component, a delivery catheter, a balloon component, a guide component and a loading component, the balloon component being connected to the control component by means of the delivery catheter, the guide component being arranged at the end of the balloon component away from the delivery catheter, and the loading component being arranged at the end of the guide component away from the balloon component. By means of the control component, the delivery system is operated and controlled to accurately deliver and release the stent body on the loading component to a proper position in the left ventricle outflow tract, thereby improving the safety of minimally invasive surgeries.

Description

Left ventricular outflow tract stent and delivery system Technical Field

[0001] The present invention relates to the technical field of medical equipment, in particular to a left ventricular outflow tract stent and a delivery system. Background Art

[0002] Patients suffering from various medical conditions or diseases may require surgical procedures to install implantable medical devices. For example, valvular regurgitation or calcified stenosis of heart valve leaflets can be treated with heart valve replacement surgery. Traditional surgical valve replacement procedures require a sternotomy and cardiopulmonary bypass, which can be highly traumatic and uncomfortable for the patient. Traditional surgical valve replacement procedures can also require a lengthy recovery period and can lead to life-threatening complications.

[0003] An alternative to traditional surgical valve replacement surgery is to use minimally invasive techniques to deliver implantable medical devices. For example, prosthetic heart valves can be delivered percutaneously and transluminally to the implantation site. In such methods, the prosthetic heart valve can be compressed or crimped onto a delivery cannula for insertion into the patient's vasculature; advanced to the implantation site; and then expanded to be deployed at the implantation site. Commonly used devices for accessing blood vessels and other locations in the body and performing various functions at these locations include medical cannulas or delivery cannulas, which are suitable for delivering and deploying medical devices (such as prosthetic heart valves, stent grafts, and stents) to selected target sites in the body. Once the cannula is guided to the target treatment deployment site and positioned there, such medical devices are typically releasably carried in a radially compressed delivery state or configuration within the distal region of the delivery cannula. However, due to the complexity of individual patient conditions, during actual surgical procedures, the release of the stent is easily affected by the internal environment due to the specificity of the cardiac environment of different patients.

[0004] Summary of the Invention

[0005] The purpose of this section is to summarize some aspects of the embodiments of the present invention and briefly introduce some preferred embodiments. Some simplifications or omissions may be made in this section and the abstract and title of this application to avoid obscuring the purpose of this section, the abstract and the title of the invention, and such simplifications or omissions should not be used to limit the scope of the present invention.

[0006] The technical problem to be solved by the present invention is how to improve the safety of minimally invasive surgery.

[0007] To solve the above technical problems, the present invention provides the following technical solutions: a left ventricular outflow tract stent, comprising a stent body, wherein the stent body is composed of a plurality of support members arranged along a first path coinciding with the left ventricular outflow tract path, the support members being annular in structure;

[0008] The support structure includes an inverted V-shaped frame and an inverted ladder-shaped frame, which are alternately arranged to form peak areas and valley areas, effectively supporting the left ventricular outflow tract, allowing blood to flow more freely, reducing blockage and pressure, and effectively avoiding obstruction of blood flow;

[0009] It also includes a connecting strip, which is arranged on the supporting member and is used for storing and fixing the bracket body.

[0010] As a preferred solution of the left ventricular outflow tract stent of the present invention, the connecting strip is provided with a protrusion, and the material of the protrusion is magnetic metal, which increases the reliability of the stent body to be accommodated and fixed.

[0011] As a preferred solution of the left ventricular outflow tract stent described in the present invention, the support member and the connecting strip are both made of memory metal, the inner layer of the support member and the connecting strip is a photodeformable layer, and the outer layer is a temperature-deformable layer. The photodeformable layer and the temperature-deformable layer are superimposed on each other, which enables the support member and the connecting strip to expand more stably and avoid accidents.

[0012] A delivery system utilizing the left ventricular outflow tract stent includes a control member, a delivery catheter, an airbag member, a guide member and a loading member. The control member is used to control the entire delivery system. The airbag member is connected to the control member via the delivery catheter to control the contraction and expansion of the airbag to perform a preliminary expansion of the installation position of the stent in the left ventricle, thereby preventing surgical intention due to the tissue force between the left ventricular regions affecting the expansion of the stent, so that the stent can be released more safely. The guide member is arranged at one end of the airbag member away from the delivery catheter to guide the stent. The loading member is arranged at one end of the guide member away from the airbag member to receive and carry the stent body.

[0013] This is a preferred solution of the delivery system of the left ventricular outflow tract stent described in the present invention, wherein: the loading component includes a light channel, a first reflecting component, a second reflecting component and a first dielectric component; the light channel is arranged on the guiding component; a light source is arranged in the light channel to act in the light channel; the first reflecting component is arranged at the periphery of the light channel, surrounds the light channel, and continuously reflects the light in the light channel; first light-transmitting areas are alternately arranged on the surface of the first reflecting component; the second reflecting component is arranged at the periphery of the first reflecting component; a part of the light passes through the second reflecting component and acts on the stent body, and another part of the light is also repeatedly refracted by the second reflecting component and acts on the stent body; a first gap is formed between the second reflecting component and the first reflecting component; the first dielectric component is arranged in the first gap; the position of the first dielectric component corresponds to the first light-transmitting area.

[0014] As a preferred solution of the delivery system of the left ventricular outflow tract stent described in the present invention, wherein: a magnetic concave layer cooperating with the protrusion is provided on the side of the first dielectric member away from the first light-transmitting area to maintain the stability of the contracted state of the stent body, prevent the stent body from accidentally expanding under the action of external force, and better fix the stent body; a reflective surface is provided on the side of the magnetic concave layer close to the first dielectric member to facilitate re-refracting the light refracted onto the first dielectric member.

[0015] As a preferred solution of the delivery system of the left ventricular outflow tract stent described in the present invention, the second reflecting component includes a first dielectric layer and a reflecting cover, the reflecting cover is arranged on the side of the first dielectric layer close to the light channel for refraction of light, and the reflecting cover is provided with a light input end and a light output end, and the size of the light input end is larger than the size of the light output end, so as to better allow the light refracted onto the second reflecting component to act on the stent body.

[0016] As a preferred solution of the delivery system for the left ventricular outflow tract stent of the present invention, the side wall of the reflecting cavity of the reflecting cover is arranged in an arc shape to better refract light.

[0017] As a preferred solution of the delivery system of the left ventricular outflow tract stent described in the present invention, the light-emitting end of the reflector is provided with a diffusion particle layer to refract the light and play a role in light diffusion to prevent the light from focusing at a fixed position.

[0018] The beneficial effects of the present invention are: by providing a stent composed of multiple annular support components, the outflow tract of the left ventricle can be effectively supported, so that blood can flow more freely, reduce blockage and pressure, and avoid blood flow obstruction. At the same time, the control component is used to control the conveying system to accurately carry and release the stent body on the loading component to the appropriate position of the left ventricular outflow tract, so as to improve the safety of minimally invasive surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. Those skilled in the art can also derive other drawings based on these drawings without inventive effort. Among them:

[0020] FIG1 is a schematic diagram of the overall structure of a left ventricular outflow tract stent.

[0021] FIG2 is a schematic diagram showing the state where the stent body is located in the heart.

[0022] FIG3 is a schematic structural diagram of a connecting strip of a left ventricular outflow tract stent.

[0023] FIG4 is a schematic diagram showing the connection between adjacent supporting members of a left ventricular outflow tract stent.

[0024] FIG5 is a schematic structural diagram of a delivery system for a left ventricular outflow tract stent.

[0025] FIG6 is a schematic diagram of the balloon component of the delivery system for the left ventricular outflow tract stent in the expanded state.

[0026] FIG7 is a schematic diagram of a balloon component of a delivery system for a left ventricular outflow tract stent in a contracted state.

[0027] FIG8 is a schematic diagram of a balloon component of a delivery system for a left ventricular outflow tract stent in a contracted state.

[0028] FIG9 is a schematic structural diagram of a loading component of a delivery system for a left ventricular outflow tract stent.

[0029] FIG10 is a schematic structural diagram of a second reflective component of a delivery system for a left ventricular outflow tract stent.

[0030] In the figure: 1. control member; 2. delivery conduit; 3. airbag member; 4. guide member; 5. loading member; 51. optical channel; 52. first gap; 53. first dielectric member; 54. magnetic concave layer; 55. second reflecting member; 551. first dielectric layer; 552. reflecting cover; 553. light output end; 554. light input end; 56. first reflecting member; 6. bracket body; 61. peak area; 62. valley area; 63. connecting strip; a. temperature deformation layer; b. photoinduced deformation layer; 64. bump. DETAILED DESCRIPTION

[0031] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0032] In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein. Those skilled in the art may make similar generalizations without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0033] Secondly, the term "one embodiment" or "embodiment" herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in various places throughout this specification does not necessarily refer to the same embodiment, nor does it refer to a separate or selective embodiment that is mutually exclusive of other embodiments.

[0034] Example 1

[0035] 1 to 4 , which are a first embodiment of the present invention, provide a left ventricular outflow tract stent, including a stent body 6 , the stent body 6 being composed of a plurality of support members arranged along a first path coinciding with the left ventricular outflow tract path, the support members being annular in structure;

[0036] The support member includes an inverted V-shaped frame and an inverted trapezoidal frame. The inverted V-shaped frame and the inverted trapezoidal frame are alternately arranged to form a peak region 61 and a valley region 62. The inverted V-shaped frame and the inverted trapezoidal frame continuously form a closed ring, so that the support member has two states: compressed and expanded. When the support member is in the compressed state, the outer wall size of the end face of the support member is smaller than the inner wall size of the storage and transportation component. When the support member is in the expanded state, the inner wall size of the end face of the support member is larger than the outer wall size of the storage and transportation component. In addition, the area of ​​the valley region 62 in the expanded state is larger than the area of ​​the valley region 62 in the compressed state, so as to effectively support the left ventricular outflow tract, allowing blood to flow more freely, reducing blockage and pressure, and effectively avoiding obstruction of blood flow.

[0037] At the same time, in the compressed state, the peak area 61 of a support member is located in the valley area 62 of the adjacent support member, and the peak area 61 and the valley area 62 of a support member are adjacent, and the inner wall of the valley area 62 exerts pressure on the outer wall of the peak area 61, which makes the structure of the bracket body 6 more stable in the compressed state, and there is a mutual force between each support member, and a single support member will not be accidentally in an expanded state; and the inner wall of the valley area 62 exerts pressure on the outer wall of the peak area 61, which increases the friction between the support members and the structural stability, avoids displacement between the support members, and stabilizes the structure.

[0038] It also includes a connecting bar 63, which is arranged on the supporting member.

[0039] A connecting bar 63 is installed on the supporting member, one end of the connecting bar 63 is connected to the V-shaped frame of a supporting member, and the other end is connected to the V-shaped frame of an adjacent supporting member. One end of the connecting bar 63 is located in the peak area 61, and the other end is located in the valley area 62. Therefore, without affecting the contraction or expansion state of the supporting member, the connecting bars 63 are connected in sequence to form a whole with the bracket body 6, so that the bracket body 6 can be stored and fixed through the connecting bar 63.

[0040] Specifically, a protrusion 64 is provided on the connecting bar 63 , and the material of the protrusion 64 is magnetic metal.

[0041] By installing a protrusion 64 on the connecting bar 63 and the material of the protrusion 64 is a magnetic metal, the bracket body 6 is limited, thereby increasing the reliability of the bracket body 6 being accommodated and fixed.

[0042] The support member and the connecting bar 63 are both made of memory metal. The inner layer of the support member and the connecting bar 63 is a photodeformable layer b, and the outer layer is a temperature-deformable layer a. The photodeformable layer b and the temperature-deformable layer a are superimposed.

[0043] The material of the support member and the connecting strip 63 are both memory metal, and the support member and the connecting strip 63 are divided into two layers, the inner layer is set as the photodeformable layer b, and the outer layer is set as the temperature deformation layer a. The temperature deformation layer a is superimposed on the photodeformable layer b, and the inner layer is closer to the storage and transportation component. When the support member is released into the blood, the temperature of the blood causes the temperature deformation layer a to expand rapidly. At the same time, the photodeformable layer b is illuminated, and the photodeformable layer b supports the temperature deformation layer a to expand and deform rapidly, so that the support member and the connecting strip 63 can expand more stably, and the photodeformable layer b and the temperature deformation layer a cooperate with each other. When there is a problem with the expansion of the photodeformable layer b or the temperature deformation layer a in some areas, the other safe deformation layer can expand, so that the support member as a whole can be in an expanded state, avoiding surgical accidents.

[0044] Example 2

[0045] 1 to 10 , a second embodiment of the present invention is provided. This embodiment provides a delivery system for a left ventricular outflow tract stent, comprising a control member 1, a delivery catheter 2, an airbag member 3, a guide member 4 and a loading member 5. The control member 1 is used to control the entire delivery system. The airbag member 3 is connected to the control member 1 through the delivery catheter 2 to control the contraction and expansion of the airbag. The guide member 4 is arranged at one end of the airbag member 3 away from the delivery catheter 2, and the loading member 5 is arranged at one end of the guide member 4 away from the airbag member 3.

[0046] The delivery system mainly consists of a control component 1, a delivery catheter 2, an airbag component 3, a guide component 4 and a loading component 5, wherein the control component 1 is used to control the entire delivery system, and the airbag component 3 is connected to the control component 1 through the delivery catheter 2. Before use, it is necessary to check whether the delivery catheter 2 is unobstructed. One end of the delivery catheter 2 is connected to the inflation component and the exhaust component on the control component 1, and the other end is connected to the airbag component 3. The inflation component acts on the airbag component 3 to put it in an expanded state, and the exhaust component acts on the airbag component 3 to put it in a contracted state, so that the airbag component 3 can adapt to different left ventricular morphologies; during operation, the installation position of the stent in the left ventricle is preliminarily expanded by the airbag component 3 to prevent surgical accidents caused by the tissue force between the left ventricular regions affecting the expansion of the stent, so that the stent can be released more safely; a guide component 4 is installed on the end of the airbag component 3 away from the delivery catheter 2 to guide the stent, and a loading component 5 is installed on the end of the guide component 4 away from the airbag component 3 to receive and carry the stent body 6.

[0047] Specifically, the loading component 5 includes an optical channel 51, a first reflecting component 56, a second reflecting component 55 and a first dielectric component 53. The optical channel 51 is arranged on the guide component 4. A light source is arranged in the optical channel 51 and acts in the optical channel 51. The first reflecting component 56 is arranged at the periphery of the optical channel 51 and surrounds the optical channel 51. First light-transmitting areas are alternately arranged on the surface of the first reflecting component 56. The second reflecting component 55 is arranged at the periphery of the first reflecting component 56. A first gap 52 is formed between the second reflecting component 55 and the first reflecting component 56. The first dielectric component 53 is arranged in the first gap 52. The position of the first dielectric component 53 corresponds to the first light-transmitting area.

[0048] A light channel 51 is installed at the end of the guide member 4 away from the airbag member 3, and an optical path is formed inside the light channel 51. The material of the light channel 51 has high transparency and stability to ensure that light can pass through. The material used for the light channel 51 can be acrylic, optical fiber, optical fiber or other materials that can transmit light. A light source is arranged in the light channel 51, and acts on the light channel 51. The light source can be an LED lamp. A first reflecting member 56 is installed on the periphery of the light channel 51. The first reflecting member 56 surrounds the entire light channel 51 and continuously reflects the light in the light channel 51. First light-transmitting areas are alternately arranged on the surface of the first reflecting member 56 to facilitate the light to be refracted through the first light-transmitting area to the outside of the first reflecting member 56. A second reflecting member 55 is installed on the periphery of the first reflecting member 56. The second reflecting member 55 is a semi-transparent and semi-reflective layer. A part of the light passing through the first light-transmitting area passes through the second reflecting member 55 and acts on the bracket body 6. Another part of the light will also be repeatedly refracted by the second reflecting component 55 and act on the bracket body 6. A first gap 52 is formed between the second reflecting component 55 and the first reflecting component 56. The medium in the first gap 52 can be air or a light-transmitting filler for supporting the second reflecting component 55. A first dielectric component 53 is installed in the first gap 52 to play a certain supporting role for the bracket body 6. The refractive index of the first medium is greater than the refractive index of the light channel 51, so that the landing point of the refracted light path on the second reflecting component 55 is oriented away from the first light-transmitting area. Through the treatment of the first dielectric component 53, the angle of light emission can be expanded to prevent too much light from being blocked and thus unable to illuminate the surface of the bracket body 6. The position of the first dielectric component 53 corresponds to the first light-transmitting area, so that the first dielectric component 53 can perform secondary refracting on the light refracted from the first light-transmitting area, so that the light acts evenly on the photodeformable layer b.

[0049] Furthermore, a magnetic concave layer 54 cooperating with the protrusion 64 is provided on the side of the first dielectric member 53 away from the first light-transmitting area. The magnetic concave layer 54 absorbs the protrusion 64 to maintain the stability of the contracted state of the bracket body 6, prevent the bracket body 6 from accidentally expanding under the action of external force, and better fix the bracket body 6. It should be noted that the magnetic attraction between the magnetic concave layer 54 and the protrusion 64 is smaller than the expansion force caused by the deformation of the bracket body 6 and the connecting strip 63 due to light and temperature, thereby preventing the bracket body 6 and the connecting strip 63 from being unable to expand. A reflective surface is provided on the side of the magnetic concave layer 54 close to the first dielectric member 53 to facilitate re-refracting the light refracted onto the first dielectric member 53, thereby improving the utilization rate of light.

[0050] The second reflective member 55 includes a first dielectric layer 551 and a reflective cover 552. The reflective cover 552 is disposed on a side of the first dielectric layer 551 close to the light channel 51. The reflective cover 552 is provided with a light inlet end 554 and a light outlet end 553. The size of the light inlet end 554 is larger than that of the light outlet end 553.

[0051] The second reflective member 55 is composed of a first dielectric layer 551 and a reflective cover 552. The reflective cover 552 is embedded in the side of the first dielectric layer 551 close to the light channel 51 for refraction of light. The reflective cover 552 is provided with a light inlet end 554 and a light outlet end 553. The size of the light inlet end 554 is larger than that of the light outlet end 553. The first dielectric layer 551 does not block the light inlet end 554 and the light outlet end 553 of the reflective cover 552. Light of some angles can enter the reflective cover 552 without being reflected by the side of the reflective cover 552. The light comes into contact with the wall and is directly refracted through the light-emitting end 553. After the light of another part of the angle enters the reflector 552, it is reflected by the inner wall of the reflector 552 to the surface of the first reflective component 56, and then reflected twice by the first reflective component 56 until the light can be emitted from the light-emitting end 553 to the surface of the bracket body 6, so as to extend the optical path of the light, thereby extending the range of the light acting on the bracket body 6, so as to better make the light refracted to the second reflective component 55 act on the bracket body 6.

[0052] The side walls of the reflective cavity of the reflector 552 are arranged in an arc shape to better refract the light. The light-emitting end 553 of the reflector 552 is provided with a diffusion particle layer, which covers the light-emitting end 553 to form a micron-level concave and convex surface. These concave and convex surfaces can refract the incident light and play a role in light diffusion to prevent the light from focusing on a fixed position.

[0053] During use, the doctor places the stent body 6 on the loading component 5, and then uses the control component 1 to perform a preliminary expansion of the installation position of the stent in the left ventricle through the airbag component 3, and then controls the loading component 5 to carry the stent to a suitable installation position. Finally, the control component 1 controls the light source to emit light, and the support component expands from a compressed state to an expanded state, so that the stent body 6 expands in the correct position, supports the left ventricular blood vessels, allows blood to flow more freely, reduces blockage and pressure, and can effectively avoid blood flow obstruction.

[0054] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A system comprising a left ventricular outflow tract stent and a delivery system, characterized in that: The left ventricular outflow tract stent comprises a stent body (6), wherein the stent body (6) is composed of a plurality of support members arranged along a first path coinciding with the left ventricular outflow tract path, and the support members are in an annular structure; The support member comprises an inverted V-shaped frame and an inverted ladder-shaped frame, wherein the inverted V-shaped frame and the inverted ladder-shaped frame are alternately arranged to form a peak region (61) and a valley region (62); It also includes a connecting strip (63), which is arranged on the supporting member and is used for storing and fixing the bracket body (6); The delivery system using the left ventricular outflow tract stent also includes a control component (1), a delivery catheter (2), an airbag component (3), a guide component (4) and a loading component (5), wherein the control component (1) is used to control the entire delivery system, the airbag component (3) is connected to the control component (1) via the delivery catheter (2) and controls the contraction and expansion of the airbag, the guide component (4) is arranged at one end of the airbag component (3) away from the delivery catheter (2), and the loading component (5) is arranged at one end of the guide component (4) away from the airbag component (3) and is used to store and carry the stent body (6); The loading component (5) comprises an optical channel (51), a first reflecting component (56), a second reflecting component (55) and a first dielectric component (53); the optical channel (51) is arranged on the guiding component (4); a light source is arranged in the optical channel (51) to act in the optical channel (51); the first reflecting component (56) is arranged at the periphery of the optical channel (51) to surround the optical channel (51); first light-transmitting areas are alternately arranged on the surface of the first reflecting component (56); the second reflecting component (55) is arranged at the periphery of the first reflecting component (56); a first gap (52) is formed between the second reflecting component (55) and the first reflecting component (56); the first dielectric component (53) is arranged in the first gap (52); and the position of the first dielectric component (53) corresponds to the first light-transmitting area.

2. The system comprising a left ventricular outflow tract stent and a delivery system as claimed in claim 1, characterized in that: The connecting strip (63) is provided with a protrusion (64), and the material of the protrusion (64) is magnetic metal.

3. The system comprising a left ventricular outflow tract stent and a delivery system as claimed in claim 1, characterized in that: The support member and the connecting strip (63) are both made of memory metal; the inner layer of the support member and the connecting strip (63) is a photodeformable layer (b), and the outer layer is a temperature-induced deformation layer (a); the photodeformable layer (b) and the temperature-induced deformation layer (a) are superimposed.

4. The system comprising a left ventricular outflow tract stent and a delivery system as claimed in claim 2, characterized in that: A magnetic concave layer (54) matching with the convex block (64) is arranged on a side of the first dielectric component (53) away from the first light-transmitting area, and a reflective surface is arranged on a side of the magnetic concave layer (54) close to the first dielectric component (53).

5. The system comprising a left ventricular outflow tract stent and a delivery system as claimed in claim 1, characterized in that: The second reflective component (55) comprises a first dielectric layer (551) and a reflective cover (552); the reflective cover (552) is arranged on a side of the first dielectric layer (551) close to the light channel (51); a light input end (554) and a light output end (553) are arranged on the reflective cover (552); and the size of the light input end (554) is larger than the size of the light output end (553).

6. The system comprising a left ventricular outflow tract stent and a delivery system as claimed in claim 5, characterized in that: The side wall of the reflection cavity of the reflection cover (552) is arranged in an arc shape.

7. The system comprising a left ventricular outflow tract stent and a delivery system as claimed in claim 5, characterized in that: A diffusion particle layer is provided at the light output end (553) of the reflector (552).

Images