Left ventricular outflow tract stent and delivery system

Abstract

The present invention discloses a left ventricular outflow tract stent and a delivery system. The left ventricular outflow tract stent includes a stent body, which consists of a plurality of support means arranged in a first path overlapping the path of the left ventricular outflow tract, the support means including an inverted V-shaped holder and an inverted trapezoidal holder, the alternating arrangement of the inverted V-shaped holder and the inverted trapezoidal holder forms a peak region and a valley region, and a connecting strip is provided on the support means. The stent delivery system includes a control means, a delivery catheter, an airbag means, a guide means, and a placement means, the airbag means being connected to the control means via the delivery catheter, the guide means being provided at one end of the airbag means away from the delivery catheter, and the placement means being provided at the other end of the guide means away from the airbag means. By operating and controlling the delivery system with the control means, the stent body on the placement means is accurately transported and released to the appropriate position in the left ventricular outflow tract, improving the safety of minimally invasive surgery.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and particularly to a left ventricular outflow tract stent and a delivery system.

Background Art

[0002] Patients suffering from various medical conditions and diseases may sometimes require surgery to implant medical devices. For example, valvular regurgitation or stenotic calcification of the heart leaflets can be treated by cardiac valve replacement surgery. Conventional surgical valve replacement surgery requires sternotomy and cardiopulmonary bypass, which can cause severe invasion and discomfort to the patient. Conventional surgical valve surgery also requires a long recovery period and may cause life-threatening complications.

[0003] As an alternative to conventional surgical valve replacement surgery, there is a method of delivering an implantable medical device using a less invasive technique. For example, an artificial heart valve can be delivered percutaneously and transcatheterically to the implantation site. In such a method, the artificial heart valve can be compressed or wrapped around a delivery catheter and inserted into the patient's vascular system, advanced to the implantation site, and then re-expanded and placed at the implantation site. Devices commonly used for access to blood vessels and other parts of the body and for realizing various functions include medical catheters or delivery catheters, which are adapted to deliver and place medical devices (such as artificial heart valves, stent grafts, stents) at selected target sites in the body. When the catheter is guided and positioned at the target treatment placement site, such a medical device is usually releasably held in the distal region of the delivery catheter in a radially compressed delivery state or configuration. However, due to the complexity of each patient's situation, in the actual surgical process, due to the particularity of the different cardiac environments for each patient, there may be a problem that the release of the stent is easily affected by the internal environment.

Summary of the Invention

Problems to be Solved by the Invention

[0004] This section aims to provide a general overview of some embodiments of the present invention and to briefly introduce some preferred embodiments. This section, as well as the specification, abstract, and title of the invention, may contain some simplifications and omissions to avoid obscuring these objectives, and such simplifications and omissions are not intended to limit the scope of the present invention.

[0005] The problem that this invention aims to solve is how to improve the safety of minimally invasive surgery. [Means for solving the problem]

[0006] To solve the above problems, the present invention provides the following technical solution: A left ventricular outflow tract stent, comprising a stent body, the stent body comprising a plurality of support means arranged along a first path arrangement that overlaps the path of the left ventricular outflow tract, the support means having an annular structure, The support means includes an inverted V-shaped holder and an inverted trapezoidal holder. By arranging the inverted V-shaped holder and the inverted trapezoidal holder alternately, peak regions and valley regions are formed, effectively supporting the left ventricular outflow tract, allowing for freer blood flow, reducing obstruction and pressure, and effectively preventing the occurrence of blood flow disorders. The support means further includes a connecting strip for housing and securing the stent body.

[0007] One preferred configuration of the left ventricular outflow tract stent described in the present invention is to provide a convex block on the connecting strip, wherein the material of the convex block is a magnetic metal, thereby improving the reliability of housing and fixing the stent body.

[0008] As one preferred configuration of the left ventricular outflow tract stent described in the present invention, the material of the support means and the connecting strip is a memory metal, the inner layer of the support means and the connecting strip is a photo-induced deformation layer, and the outer layer is a temperature-deformable layer, and the photo-induced deformation layer and the temperature-deformable layer are superimposed to allow the support means and the connecting strip to expand more stably and avoid accidents.

[0009] A delivery system utilizing the left ventricular outflow tract stent described above, comprising a control means, a delivery catheter, an airbag means, a guide means, and a placement means, wherein the control means is used to control the entire delivery system, the airbag means is connected to the control means via the delivery catheter and controls the deflation and deployment of the airbag, thereby pre-expanding the stent placement site in the left ventricle, preventing unintended intraoperative situations caused by tissue forces between left ventricular regions affecting stent expansion, and allowing for safer stent release, the guide means is provided at one end of the airbag means away from the delivery catheter to guide the stent, and the placement means is provided at the other end of the guide means away from the airbag means to house and transport the stent body.

[0010] As one preferred solution for a left ventricular outflow tract stent delivery system according to the present invention, the aforementioned means includes an optical path, a first reflecting means, a second reflecting means, and a first medium means, wherein the optical path is provided on the guide means, a light source acting within the optical path is arranged within the optical path, the first reflecting means is provided around the optical path and surrounds the optical path, reflecting light within the optical path in succession, first light-transmitting regions are alternately arranged on the surface of the first reflecting means, the second reflecting means is provided around the first reflecting means, some light rays pass through the second reflecting means and act on the stent body, other some light rays are repeatedly refracted by the second reflecting means and act on the stent body, a first gap is formed between the second reflecting means and the first reflecting means, the first medium means is provided within the first gap, and the position of the first medium means corresponds to a first light-transmitting region.

[0011] As one preferred solution for the left ventricular outflow tract stent delivery system described in the present invention, a magnetic recess layer matching a convex block is provided on one side of the first medium means away from the first light-transmitting region, thereby maintaining the stability of the contracted state of the stent body, preventing unintended expansion of the stent body due to external forces, better fixing the stent body, and a reflective surface is provided on one side of the magnetic recess layer closer to the first medium means, making it easier to rerefract the light rays refracted by the first medium means.

[0012] As one preferred solution for the left ventricular outflow tract stent delivery system described in the present invention, the second reflective means includes a first medium layer and a reflective cover, the reflective cover being provided on one side of the first medium layer near the optical path and used to refract light rays, the reflective cover being provided with an incoming end and an outgoing end, the dimensions of the incoming end being larger than the dimensions of the outgoing end, thereby allowing the light rays refracted by the second reflective means to act more effectively on the stent body.

[0013] As one preferred solution for the left ventricular outflow tract stent delivery system described in the present invention, the reflective cavity sidewalls of the reflective cover are arranged in an arc shape to better refract light rays.

[0014] As one preferred solution for the left ventricular outflow tract stent delivery system described in the present invention, a diffusing particle layer is provided at the light-emitting end of the reflective cover to scatter light rays and produce a light-diffusing effect, preventing light from concentrating in one place. [Effects of the Invention]

[0015] The beneficial effects of the present invention are as follows: By providing a stent consisting of multiple annular support means, the outflow tract of the left ventricle can be effectively supported, blood flow can be made freer, obstruction and pressure can be reduced, and the occurrence of blood disorders can be effectively avoided. Furthermore, by operating and controlling the delivery system with a control means, the stent body in the placement means can be accurately transported and released to the appropriate site in the left ventricular outflow tract, thereby improving the safety of minimally invasive surgery. [Brief explanation of the drawing]

[0016] To more clearly illustrate the technical solution of the embodiments of the present invention, the drawings that need to be used in the following description of the embodiments will be briefly introduced below. As is clear, the drawings in the following description are merely some embodiments of the present invention, and those skilled in the art can also obtain other drawings based on these drawings without creative effort.

[0017] [Figure 1] It is a schematic diagram of the overall structure of the left ventricular outflow tract stent. [Figure 2] It is a schematic diagram of the state where the stent body is located in the heart. [Figure 3] It is a schematic structural diagram of the connection strip of the left ventricular outflow tract stent. [Figure 4] It is a schematic diagram of the connection between adjacent support means of the left ventricular outflow tract stent. [Figure 5] It is a schematic structural diagram of the delivery system of the left ventricular outflow tract stent transporting the stent. [Figure 6] It is a schematic diagram of the expanded state of the airbag means of the delivery system of the left ventricular outflow tract stent. [Figure 7] It is a schematic diagram of the contracted state of the airbag means of the delivery system of the left ventricular outflow tract stent. [Figure 8] It is a schematic diagram of the contracted state of the airbag means of the delivery system of the left ventricular outflow tract stent. [Figure 9] It is a schematic structural diagram of the placement means of the delivery system of the left ventricular outflow tract stent. [Figure 10] It is a schematic structural diagram of the second reflection means of the delivery system of the left ventricular outflow tract stent.

Embodiments for Carrying Out the Invention

[0018] To make the above objects, features, and advantages of the present invention more clear, the specific embodiments of the present invention will be described in detail below with reference to the drawings.

[0019] In the following description, many specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components and circuits have not been described in detail so as not to unnecessarily obscure aspects of the present invention. The present invention is not limited to the specific embodiments disclosed herein and can be implemented in other ways without departing from the concept of the present invention. Those skilled in the art can make analogies without departing from the concept of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0020] Next, as used herein, "one embodiment" or "an embodiment" means a particular feature, structure, or characteristic in at least one implementation manner that can be included in the present invention. The phrase "in one embodiment" appearing at different places in this specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments.

Embodiment

[0021] Referring to FIGS. 1 to 4, a first embodiment of the present invention is provided. This embodiment provides a left ventricular outflow tract stent, including a stent body 6. The stent body 6 consists of a plurality of support means arranged along a first path overlapping the path of the left ventricular outflow tract. The support means has an annular structure. The support means includes an inverted V-shaped holder and an inverted trapezoidal holder. By alternately arranging the inverted V-shaped holder and the inverted trapezoidal holder, a peak region 61 and a valley region 62 are formed. The inverted V-shaped holder and the inverted trapezoidal holder continuously form an annular structure that is closed. The support means has two states of compression and expansion. When the support means is in the compressed state, the outer wall dimension of the end face of the support means is smaller than the inner wall dimension of the accommodating / transporting member. When the support means is in the expanded state, the inner wall dimension of the end face of the support means is larger than the outer wall dimension of the accommodating / transporting member, and 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. Thereby, the left ventricular outflow tract can be effectively supported, the blood flow can be made freer, the occlusion and pressure can be reduced, and the occurrence of blood disorders can be effectively avoided. Simultaneously, in the compressed state, the peak region 61 of one support means is located in the valley region 62 of the adjacent support means, and the peak region 61 of one support means is adjacent to the valley region 62, and the inner wall of the valley region 62 applies pressure to the outer wall of the peak region 61, thereby making the structure of the stent body 6 more stable in the compressed state, providing mutual biasing forces between each support means, preventing a single support means from unintentionally expanding, and the inner wall of the valley region 62 applies pressure to the outer wall of the peak region 61, thereby improving the frictional force and structural stability between the support means, avoiding displacement between the support means, and stabilizing the structure.

[0022] The system further includes a connecting strip 63 provided on the support means.

[0023] The connecting strips 63 are attached to the support means, one end of the connecting strip 63 is connected to an inverted V-shaped holder of one support means, and the other end is connected to an inverted V-shaped holder of an adjacent support means, one end of the connecting strip 63 is located in the peak region 61 and the other end is located in the valley region 62, and the connecting strips 63 are connected in sequence and integrated with the stent body 6, on the premise that they do not affect the contracted or expanded state of the support means, thereby housing and fixing the stent body 6 with the connecting strips 63.

[0024] Specifically, a convex block 64 is provided on the connecting strip 63, and the material of the convex block 64 is a magnetic metal.

[0025] By attaching a convex block 64 to the connecting strip 63, and by making the convex block 64 out of magnetic metal, the position of the stent body 6 is restricted, improving the reliability of housing and fixing the stent body 6.

[0026] The material of both the support means and the connecting strip 63 is memory metal. The inner layer of the support means and the connecting strip 63 is a photo-induced deformation layer b, and the outer layer is a temperature-induced deformation layer a. The photo-induced deformation layer b and the temperature-induced deformation layer a are superimposed on each other.

[0027] The support means and connecting strip 63 are both made of memory metal, and the support means and connecting strip 63 are divided into two layers, inner and outer. The inner layer is provided as a photo-induced deformation layer b, and the outer layer is provided as a temperature deformation layer a. The temperature deformation layer a is superimposed on the photo-induced deformation layer b, and the inner layer is closer to the containment and transport member. When the support means is released into the blood, the temperature of the blood rapidly expands the temperature deformation layer a, and light is irradiated onto the photo-induced deformation layer b, which supports the rapid expansion and deformation of the temperature deformation layer a. As a result, the support means and connecting strip 63 can expand more stably, and the photo-induced deformation layer b and temperature deformation layer a cooperate with each other. If a problem occurs in the expansion of the photo-induced deformation layer b or temperature deformation layer a in a certain area, the other safe deformation layer can expand, so that the entire support means can remain expanded and unintended situations during surgery can be avoided. [Examples]

[0028] Referring to Figures 1 to 10, a second embodiment of the present invention provides a delivery system utilizing a left ventricular outflow tract stent, comprising a control means 1, a delivery catheter 2, an airbag means 3, a guide means 4, and a placement means 5, wherein the control means 1 is used to control the entire delivery system, the airbag means 3 is connected to the control means 1 via the delivery catheter 2 and controls the deflation and deployment of the airbag, the guide means 4 is provided at one end of the airbag means 3 away from the delivery catheter 2, and the placement means 5 is provided at the other end of the guide means 4 away from the airbag means 3.

[0029] The delivery system mainly consists of a control means 1, a delivery catheter 2, an airbag means 3, a guide means 4, and a mounting means 5. The control means 1 is used to control the entire delivery system, and the airbag means 3 is connected to the control means 1 via the delivery catheter 2. Before use, it is necessary to check the smoothness of the delivery catheter 2. One end of the delivery catheter 2 is connected to the gas filling member and gas exhaust member in the control means 1, and the other end is connected to the airbag means 3. The gas filling member acts on the airbag means 3 to deploy it, and the gas exhaust member acts on the airbag means 3 to deflate it, thereby allowing the airbag means 3 to accommodate different left ventricular morphologies. During the operation, the airbag means 3 pre-expands the stent placement position within the left ventricle, preventing tissue forces between left ventricular regions from affecting stent expansion and causing unintended situations during the procedure, thus allowing for safer stent release. A guide means 4 is attached to one end of the airbag means 3 away from the delivery catheter 2 and is used to guide the stent. A mounting means 5 is attached to the other end of the guide means 4 away from the airbag means 3 and is used to house and transport the stent body 6.

[0030] Specifically, the mounting means 5 includes an optical path 51, a first reflective means 56, a second reflective means 55, and a first medium means 53. The optical path 51 is provided on the guide means 4, and a light source acting within the optical path 51 is placed inside the optical path 51. The first reflective means 56 is provided around the optical path 51, surrounding it, and first light-transmitting regions are alternately arranged on the surface of the first reflective means 56. The second reflective means 55 is provided around the first reflective means 56, and a first gap 52 is formed between the second reflective means 55 and the first reflective means 56. The first medium means 53 is provided inside the first gap 52, and the position of the first medium means 53 corresponds to the first light-transmitting region.

[0031] An optical path 51 is attached to one end of the guide means 4 away from the airbag means 3, and an optical path is formed inside the optical path 51. The material of the optical path 51 has relatively high transparency and stability to ensure that light rays can pass through. The material used for the optical path 51 may be acrylic, optical fiber, light guide fiber, or other material capable of transmitting light rays. A light source is placed inside the optical path 51 and acts within the optical path 51. The light source may be an LED lamp. A first reflective means 56 is attached around the optical path 51, and the first reflective means 56 surrounds the entire optical path 51, reflecting the light inside the optical path 51 one after another. First light-transmitting regions are alternately arranged on the surface of the first reflective means 56, so that light rays pass through the first light-transmitting regions and are easily refracted outside the first reflective means 56. A second reflective means 55 is attached around the stent body 6, and the second reflective means 55 is a layer of half-mirrors. Light rays that have passed through the first light-transmitting region partially pass through the second reflective means 55 and act on the stent body 6, and another portion of the light rays act on the stent body 6 by being repeatedly refracted by the second reflective means 55. A first gap 52 is formed between the second reflective means 55 and the first reflective means 56. The medium in the first gap 52 may be air or a light-transmitting filler to support the second reflective means 55. A first medium means 53 is attached in the first gap 52, providing a certain support to the stent body 6. The refractive index of the first medium is greater than that of the optical path 51, so that the position of the refracted optical path at the second reflective means 55 moves away from the first light-transmitting region. Through processing by the first mediating means 53, the light emission angle can be increased, preventing excessive light rays from being blocked and not irradiating the surface of the stent body 6. The position of the first mediating means 53 corresponds to the first light transmission region, and the first mediating means 53 rerefracts the light rays refracted from the first light transmission region, so that the light rays act uniformly on the photo-induced deformation layer b.

[0032] Furthermore, a magnetic recess 54 matching the convex block 64 is provided on one side of the first media means 53 away from the first light-transmitting region. The magnetic recess 54 attracts the convex block 64, thereby maintaining the stability of the contracted state of the stent body 6, preventing the stent body 6 from unintentionally expanding due to external force, and more securely fixing the stent body 6. The magnetic attractive force between the magnetic recess 54 and the convex block 64 is smaller than the expansion force of deformation generated by light irradiation and temperature in the stent body 6 and connecting strip 63, thus preventing the stent body 6 and connecting strip 63 from expanding. A reflective surface is provided on one side of the magnetic recess 54 closer to the first media means 53, rerefracting the light rays refracted by the first media means 53 and improving the utilization rate of the light rays.

[0033] The second reflective means 55 includes a first medium layer 551 and a reflective cover 552, the reflective cover 552 is provided on one side of the first medium layer 551 closer to the light path 51, the reflective cover 552 is provided with an incoming light end 554 and an outgoing light end 553, and the dimensions of the incoming light end 554 are larger than the dimensions of the outgoing light end 553. The second reflective means 55 consists of a first medium layer 551 and a reflective cover 552, the reflective cover 552 is fitted to one side of the first medium layer 551 that is close to the light path 51 and is used for refraction of light rays, the reflective cover 552 is provided with an incoming end 554 and an outgoing end 553, the dimensions of the incoming end 554 are larger than the dimensions of the outgoing end 553, the first medium layer 551 does not obstruct the incoming end 554 and the outgoing end 553 of the reflective cover 552, and a part The angled rays, after entering the reflective cover 552, do not contact the side wall of the reflective cover 552 but are directly refracted by the light-emitting end 553. Another portion of the rays, after entering the reflective cover 552, are reflected by the inner wall of the reflective cover 552, causing the rays to be reflected back to the surface of the first reflecting means 56. Furthermore, the first reflecting means 56 secondarily reflects the rays until they can enter the surface of the stent body 6 from the light-emitting end 553, thereby extending the optical path of the rays. This expands the range over which the rays act on the stent body 6, allowing the rays refracted by the second reflecting means 55 to act more effectively on the stent body 6.

[0034] The side walls of the reflective cavity of the reflective cover 552 are arranged in an arc shape to better refract light rays, and a diffuse particle layer is placed at the light-emitting end 553 of the reflective cover 552. The diffuse particle layer covers the light-emitting end 553, forming a micron-level uneven surface. These uneven surfaces can scatter the incident light rays, performing a light diffusion effect and preventing the light from concentrating at one fixed point.

[0035] During use, the physician places the stent body 6 in the placement means 5. Next, the control means 1 pre-inflates the airbag means 3 to the stent placement position in the left ventricle. Then, the placement means 5 is controlled to transport the stent to the appropriate placement position. Finally, the control means 1 controls the light source to emit light, and the support means expands from a compressed state to an expanded state. As a result, the stent body 6 expands to the precise position, supporting the left ventricular vessel, allowing for freer blood flow, reducing occlusion and pressure, and effectively preventing blood flow impairment.

[0036] The above embodiments are used merely to illustrate the technical aspects of the present invention and are not restrictive. While the present invention has been described in detail with reference to preferred embodiments, it will be understandable to those skilled in the art that the technical aspects of the present invention can be modified or replaced with equivalents without departing from the spirit and scope of the technical aspects, and such modifications or substitutions are all included within the scope of the utility model claims. [Explanation of Symbols]

[0037] 1. Control means 2. Delivery Catheter 3. Airbag mechanism 4. Guidance methods 5. Mounting means 51 Light passage 52 The first gap 53 First media means 54 Magnetic concave layer 55 Second Reflecting Means 551 The first media layer 552 Reflective cover 553 Light output terminal 554 Light-receiving end 56 First Reflecting Means 6 Stent Body 61 Peak Region 62 Valley area 63 connection strips 64 Convex Blocks a. Temperature deformation layer b. Photo-induced deformation layer

Claims

1. A system comprising a left ventricular outflow tract stent and a delivery system, wherein the left ventricular outflow tract stent comprises a stent body (6), the stent body (6) consists of a plurality of support means arranged along a first path that overlaps the path of the left ventricular outflow tract, the support means having an annular structure, The support means includes an inverted V-shaped holder and an inverted trapezoidal holder, and by arranging the inverted V-shaped holder and the inverted trapezoidal holder alternately, a peak region (61) and a valley region (62) are formed. The support means further includes a connecting strip (63) for housing and fixing the stent body (6), The delivery system using the left ventricular outflow tract stent further includes a control means (1), a delivery catheter (2), an airbag means (3), a guide means (4), and a placement means (5), wherein the control means (1) is used to control the entire delivery system, the airbag means (3) is connected to the control means (1) via the delivery catheter (2) and controls the deflation and deployment of the airbag, the guide means (4) is provided at one end of the airbag means (3) away from the delivery catheter (2), and the placement means (5) is provided at the other end of the guide means (4) away from the airbag means (3) and is used to house and transport the stent body (6). A system including a left ventricular outflow tract stent and a delivery system, wherein the mounting means (5) includes an optical path (51), a first reflective means (56), a second reflective means (55), and a first medium means (53), the optical path (51) being provided on the guide means (4), a light source acting within the optical path (51) being arranged within the optical path (51), the first reflective means (56) being provided around the optical path (51) and surrounding the optical path (51), first light-transmitting regions being alternately arranged on the surface of the first reflective means (56), the second reflective means (55) being provided around the first reflective means (56), a first gap (52) being formed between the second reflective means (55) and the first reflective means (56), the first medium means (53) being provided within the first gap (52), and the position of the first medium means (53) corresponding to a first light-transmitting region.

2. A system comprising a left ventricular outflow tract stent and a delivery system according to claim 1, characterized in that a convex block (64) is provided on the connecting strip (63), and the material of the convex block (64) is a magnetic metal.

3. The system comprising a left ventricular outflow tract stent and a delivery system according to claim 1, characterized in that the material of the support means and the connecting strip (63) is a memory metal, the inner layer of the support means and the connecting strip (63) is a photo-induced deformation layer (b), the outer layer is a temperature-deformable layer (a), and the photo-induced deformation layer (b) and the temperature-deformable layer (a) are superimposed.

4. A system comprising a left ventricular outflow tract stent and a delivery system according to claim 2, characterized in that a magnetic recess layer (54) matching a convex block (64) is provided on one side of the first media means (53) away from the first light-transmitting region, and a reflective surface is provided on one side of the magnetic recess layer (54) closer to the first media means (53).

5. The system comprising a left ventricular outflow tract stent and a delivery system according to claim 1, wherein the second reflective means (55) includes a first medium layer (551) and a reflective cover (552), the reflective cover (552) being provided on one side of the first medium layer (551) near the optical path (51), the reflective cover (552) being provided with an incoming end (554) and an outgoing end (553), and the dimensions of the incoming end (554) being greater than the dimensions of the outgoing end (553).

6. The system comprising a left ventricular outflow tract stent and a delivery system according to claim 5, characterized in that the side walls of the reflective cavity of the reflective cover (552) are arranged in an arc shape.

7. The system comprising a left ventricular outflow tract stent and a delivery system according to claim 5, characterized in that a diffusion particle layer is provided at the light-emitting end (553) of the reflective cover (552).

Images