Interventional heart valve stent delivery system

Abstract

The delivery system of the interventional heart valve stent (200) is removably connected to both ends of the heart valve stent (200) by a stent fixing assembly, and the support tube (12) moves along the axial direction of the inner core (11), thereby realizing the insertion and removal of the heart valve stent (200) into and from the capsule cavity (23) or the receiving cavity, and further realizing a bidirectional detachable connection method, which makes the release position of the heart valve stent (200) more accurate than the one-sided fixation method, and avoids unnecessary adjustment work.

Description

[Technical field]

[0001] The present invention relates to the technical field of interventional heart valve surgery related devices, in particular to a delivery system for interventional heart valve stents. [Background technology]

[0002] With the aging of the human population, the incidence of valvular heart disease has obviously increased. At present, traditional surgical treatment is still the first-choice treatment for many patients with severe valvular disease, but it has the risks of large wounds, high postoperative mortality, and high complications. In recent years, transcatheter valve implantation / repair has gradually matured and been widely applied, especially transcatheter aortic valve implantation (TAVR / TAVI), which has sufficient evidence-based medical evidence, significantly reduced wounds, and has been recommended by the European and American Heart Valve Disease Treatment Guide, which is a milestone development in the field of heart valve disease intervention treatment.

[0003] Transcatheter aortic valve implantation (TAVI) is a new technique for implanting an artificial aortic valve using an interventional method. It was first reported by Dr. Criber of France in 2002, bringing hope to the treatment of patients with severe aortic stenosis (AS) who lost the opportunity for surgery (e.g., >80 years old), and adding a new page to the history of interventional treatment of cardiovascular disease. Over the next 10 years, with the improvement of equipment and the accumulation of experience, the TAVI technique has been perfected and has been continuously performed in 230 cardiac centers in about 40 countries, with a total number of surgeries exceeding 150,000. In particular, after a series of registration studies and randomized controlled studies have confirmed its efficacy, feasibility and safety, the TAVI technique has become the first-choice treatment method for severe AS patients who cannot undergo surgical valve replacement. In clinical practice, there are two types of artificial biological valves used in TAVI: Edwards Sapien (Edwards, USA), which is implanted by balloon expansion, and CoreValve (Medtronic, USA), which is implanted by self-expansion. TAVI technology has already made remarkable progress internationally, and has already been applied in China to a preliminary extent, and has a similarly broad future. At present, the domestic heart valve device market in China is highly monopolized by foreign brands, with foreign companies such as Edwards Lifesciences, Medtronic, LivaNova (already acquired by Sorin), St. Jude Medical (already acquired by Abbott) and On-X occupying about 85% of the market share. Edwards Lifesciences and Medtronic have a full product line from mechanical valves and biological valves to transcatheter interventional valves, and domestic device companies have also appeared in China. Currently, three domestic transcatheter aortic valves have been approved by the Chinese CFDA and are on the market, namely, Qiming Medical's Venus-A, Suzhou Jiecheng's J-valve, and Weichuang Xintong's VitaFlow. However, there is still no company with absolute advantage among domestic companies in China.

[0004] According to the statistical analysis of the hospital patient ultrasound electrocardiogram database, in patients aged 65-74 (49995 cases) and ≥ 75 years (34671 cases), the detection rates of moderate or severe aortic regurgitation (AR) were 2.12% and 2.85%, respectively, and the detection rates of moderate or severe aortic stenosis (AS) were 0.75% and 0.89%, respectively, and the detection rates of severe aortic regurgitation (SAR) and severe aortic stenosis (SAS) in the two sets of patients were 0.52% VS 0.95%, 0.54% VS 0.57%, respectively. It can be seen that Chinese elderly people tend to suffer from aortic regurgitation in aortic valve degenerative lesions. There is a certain difference between Chinese patients with aortic valve disease and patients in Western countries. (1) The proportion of Chinese patients with bicuspid aortic valves is high, ranging from 40% to 23%, much higher than the 1.6% to 9.3% of patients in Western countries, and bicuspid aortic valves are used as the exclusion criterion in many large-scale TAVR clinical studies in Western countries. (2) The aortic valves of Chinese patients have a high degree of calcification. (3) Aortic regurgitation is more common in Chinese patients than aortic stenosis. (4) The femoral artery internal diameter is small, with the average femoral artery internal diameter of 6.5 mm in Chinese TAVR candidate cases.

[0005] Although the delivery system can deliver and deploy the prosthetic valve stent to the aortic valve, complete the placement of the prosthetic valve, and restore the function of the valve, there are still many problems in the loading of the delivery system and the prosthetic valve stent that affect the accurate release of the prosthetic valve stent. Summary of the Invention [Problem to be solved by the invention]

[0006] Based on the above situation, the present invention provides an interventional heart valve stent delivery system which satisfies the accommodation and release of a heart valve stent. [Means for solving the problem]

[0007] The delivery system for interventional heart valve stents is a delivery catheter assembly and a stent fixation assembly, The delivery catheter assembly includes a movable inner core, a support tube, an inner sheath, and an outer sheath, which are fitted in this order from the inside to the outside, and both ends of the inner core extend from both ends of the support tube, respectively, and a distal end of the inner sheath has a receiving cavity; The stent fixation assembly is removably connected to both ends of the heart valve stent, and the stent fixation assembly includes a capsule cavity, a distal end of the inner core is inserted through an opening at a proximal end of the capsule cavity and fixedly connected to the capsule cavity, and the support tube is capable of axially moving the heart valve stent in and out of the capsule cavity or receiving cavity.

[0008] The technical means by which the present invention solves the above technical problems are as follows.

[0009] The interventional heart valve stent delivery system according to the embodiment of the present application is detachably connected to both ends of the heart valve stent by a stent fixing assembly, and the support tube moves along the axial direction of the inner core to realize the heart valve stent entering and leaving the capsule cavity or receiving cavity, and further realizes a bidirectional detachable connection manner, which makes the release position of the heart valve stent more accurate than the one-sided fixation method and avoids unnecessary adjustment work.

[0010] Based on the above technical means, the present invention can be improved as follows.

[0011] Furthermore, the stent fixation assembly further includes a fixation member, a fixation block, and a position limiting member; the fixation member has a support arm connected to the support tube and extending to a distal end thereof, the fixation block is connected to the distal end of the support tube, the support arm and the fixation block being configured to be removably connected to a proximal end and a distal end of a heart valve stent, respectively; The position limiting member is a thin, elongated structure that can axially penetrate the support tube and extend from both ends of the support tube, and the distal end of the position limiting member is used to connect and limit the position of the proximal end of the heart valve stent to the support arm so as to prevent the proximal end of the heart valve stent from coming off the support arm.

[0012] Furthermore, the opening diameter of the capsule cavity is radially expandable, and a guide member is located adjacent to the distal end of the support tube, and the guide member can guide the capsule cavity to move into the outer sheath.

[0013] Further, the guide member includes a connecting portion and a plurality of guide arms, the connecting portion being fixedly connected to an outer wall of the support tube, the guide arms extending toward a distal end and resiliently expandable outwardly.

[0014] Additionally, the distal end of the guide arm has a transition portion that curves relative to the guide arm proximate the axis of the support tube.

[0015] Furthermore, the capsule cavity includes a cavity body and a fence opening, the cavity body has a straight cylindrical structure, the fence opening is straight cylindrical when no external force is applied and can expand into a trumpet shape when an external force is applied, and the inside of the guide arm can elastically press the fence opening.

[0016] Further, the fence opening has a plurality of axial notches, the axial notches being uniformly distributed around the periphery of the capsule cavity, and the portions between adjacent axial notches defining fence rungs.

[0017] Furthermore, the side surface of the cavity body has a plurality of arcuate notches of equal length, the arcuate notches are distributed along the axial direction of the cavity body, adjacent arcuate notches are offset, and the gap portions between both ends of all the arcuate notches are connected to form a connecting rib that is spiral along the axial direction.

[0018] Furthermore, the delivery system further includes a control handle and two curvature adjustment handles, the control handle is connected to a proximal end of the support tube and can move the support tube along an axial direction, the control handle has a first stroke assembly for controlling the axial movement distance of the support tube, the two curvature adjustment handles are provided at the proximal end of the inner sheath and the proximal end of the outer sheath, respectively, and curve the corresponding distal ends of the inner sheath and the outer sheath in the same plane or different planes by a puller wire, and the curvature adjustment handle has a second stroke assembly for controlling the curvature of the corresponding inner sheath or outer sheath.

[0019] Further, the control handle is arranged along the axial direction of the support tube, the two curvature adjustment handles are arranged in sequence on a side of the control handle close to the distal end of the support tube, the curvature adjustment handle for adjusting the inner sheath is arranged closer to the control handle, the curvature adjustment handle includes an axial portion and a branched portion, the axial portion is arranged along the axial direction of the support tube, the proximal ends of the inner sheath and the outer sheath are fixed to the corresponding axial portions of the curvature adjustment handles, the branched portion forms an acute angle with the axial portion, and the second stroke assembly is arranged at the branched portion.

[0020] Further, the control handle includes a handle body sleeve, a control sleeve and a control slider, the first stroke assembly includes a first stroke sleeve and a first stroke indicating member, and has an axial control slide rail inside the handle body sleeve, the inside of the control sleeve slides the control slider along the axial control slide rail by screwing, the support tube is fixed to the distal end of the handle body sleeve, the support tube is inserted from the distal end of the handle body sleeve and fixed to the control slider, the first stroke sleeve is fixedly fitted to the outside of the control sleeve, the first stroke sleeve has a first stroke slide rail arranged along the axial direction, and the outside of the control sleeve slides the first stroke indicating member along the first stroke slide rail by screwing.

[0021] Furthermore, the control handle further includes a detachable member, which is removably attached to the proximal end of the handle body sleeve and connected to the proximal end of the position limiting member, and when the heart valve stent is positioned inside the capsule cavity, by pulling the position limiting member with the detachable member, the distal end of the position limiting member releases the connection and position limit to the proximal end of the heart valve stent and the support arm.

[0022] Further, the axial portion includes an axial sleeve, a hemostasis valve, and a proximal end fixing cover, and has an axial through hole inside the axial sleeve, the proximal ends of the inner sheath and the outer sheath are inserted and fixed from the corresponding distal ends of the axial sleeve, the axial sleeve has a lateral wire hole corresponding to the branched portion, the hemostasis valve is provided at a position adjacent to the proximal end of the axial sleeve and has an elastically contractible hemostasis channel, and the proximal end fixing cover is fixed to the proximal end of the axial sleeve and has a duct through hole.

[0023] Furthermore, the hemostasis valve includes at least one valve group, the valve group including a valve sleeve and a first valve, a second valve, and a third valve arranged coaxially in order from a proximal end to a distal end, the first valve has a first hole formed in a central portion thereof, the first valve has non-penetrating notches formed on both sides thereof, and the notches on both sides are arranged alternately, the second valve has a central portion protruding toward the distal end, and a second hole formed in its central position, and the second valve has an annular step on the side adjacent to the third valve. a difference is formed, the third valve includes an elastic tube and two elastic valves, the elastic valves are connected to the inner wall of the elastic tube, the distal ends of the two elastic valves form an openable and closable valve port, the distal ends of the elastic valves and the inner wall of the elastic tube have an elastic support rib for elastically closing the valve port, the annular step is incorporated into the proximal end opening of the elastic tube, the valve sleeve is a cylindrical member, and the elastic tube is partially or completely incorporated into the valve sleeve, and the first hole, the second hole and the valve port constitute the hemostasis channel.

[0024] Further, the branched portion includes a branched body, a curvature adjustment slider, and a curvature adjustment sleeve, the second stroke assembly includes a second stroke sleeve and a second stroke indicating member, the branched body includes an axial fixing tube and a guide tube provided in communication with each other, the axial fixing tube is coaxially fixed to the outside of the axial sleeve, the guide tube is provided corresponding to the lateral wire hole, the guide tube extends toward the proximal end and is provided to form a predetermined acute angle with the axial fixing tube, the inside of the guide tube has a curvature adjustment guide slide rail along its axial direction, the proximal end of the pulling wire is fixed to the curvature adjustment slider, the inside of the curvature adjustment sleeve slides the curvature adjustment slider along the curvature adjustment guide slide rail by screwing, the second stroke sleeve is fixedly fitted to the outside of the curvature adjustment sleeve, the second stroke sleeve has a second stroke slide rail, and the outside of the curvature adjustment sleeve slides the second stroke indicating member along the second stroke slide rail by screwing. [Brief description of the drawings]

[0025] [Figure 1] FIG. 2 is a structural schematic diagram of a delivery system for an interventional heart valve stent according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a schematic diagram of a heart valve stent connection in an embodiment of the present application. [Diagram 3] 3 is a structural schematic diagram of a fixing member in an embodiment of the present application. FIG. [Figure 4] FIG. 2 is a structural schematic diagram of a fixing block in an embodiment of the present application. [Diagram 5] FIG. 2 is a schematic diagram of the positional relationship between a guide member, a fixed block, and a capsule cavity in an embodiment of the present application. [Figure 6] 4 is a schematic diagram of the structure of a guide member in an embodiment of the present application. FIG. [Figure 7] FIG. 2 is a structural schematic diagram of a capsule cavity in an embodiment of the present application. [Figure 8] FIG. 2 is a schematic diagram of the external structure of a control handle in an embodiment of the present application. [Figure 9] FIG. 2 is a cross-sectional view of a control handle in accordance with an embodiment of the present application. [Figure 10] FIG. 2 is a schematic diagram of the external structure of a curvature adjustment handle in an embodiment of the present application. [Figure 11] 1 is a schematic diagram of an internal structure of a curvature adjustment handle in an embodiment of the present application. [Figure 12] 1 is a schematic structural diagram of a hemostasis valve in an embodiment of the present application. [Figure 13] FIG. 2 is a structural schematic diagram of a third valve in an embodiment of the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] In order to facilitate an understanding of the present application, the present application will now be described more fully with reference to the associated drawings, in which examples of the present application are shown. However, the present application may be embodied in many different forms and is not limited to the examples set forth herein. On the contrary, the purpose of providing these examples is to provide a more complete and thorough understanding of the present disclosure.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terms used herein in the description of this application are for the purpose of describing specific examples only and are not intended to be limiting of the application.

[0028] An embodiment of the present application provides a delivery system for an interventional heart valve stent, which is primarily used for delivering a heart valve stent from outside the body to a cardiac site of a patient, and includes a delivery catheter assembly and a stent fixation assembly.

[0029] The delivery catheter assembly, as a basic component of the delivery system, includes a movable inner core 11, a support tube 12, an inner sheath 13 and an outer sheath 14, which are fitted from the inside to the outside, as shown in Figure 1, with both ends of the inner core 11 extending from both ends of the support tube 12, and the distal end of the inner sheath 13 having an accommodation cavity.

[0030] It should be noted that in this application and its embodiments, the proximal end is the end closer to the user when the delivery system is in use, and the distal end is the end closer to the patient.

[0031] The stent fixation assembly is removably connected to both ends of a heart valve stent 200 (see FIG. 2 ) so that the heart valve stent can be positioned at a defined portion of the stent fixation assembly, typically the distal end portion, the stent fixation assembly including a capsule cavity 23, the distal end of the inner core 11 is inserted through an opening at the proximal end of the capsule cavity 23 and fixedly connected to the capsule cavity 23, and the support tube 12 can move the heart valve stent 200 axially to move the heart valve stent 200 in and out of the capsule cavity 23 or receiving cavity.

[0032] Between the support tube 12 and the inner sheath 13 there is a further layer of inner tube (not shown) whose main function is support, moving the support tube 12 within the inner tube, and a TIP head is provided at the distal end of the capsule cavity 23, which is naturally formed in a pig-tail shape.

[0033] As one of the connection methods of the cardiac valve stent 200 according to the present application, the stent fixing assembly further includes a position limiting member 21 , a fixing member 22 and a fixing block 24 .

[0034] The fixing member 22 has a support arm 221 which is connected to the support tube 12 and extends to a distal end thereof and is used for releasably connecting to the proximal end of the heart valve stent 200, and a fixing block 24 which is connected to the distal end of the support tube 12 and is used for releasably connecting to the distal end of the heart valve stent 200.

[0035] The position limiting member 21 is a thin, elongated structure that can penetrate the support tube 12 in the axial direction and extend from both ends of the support tube 12. The distal end of the position limiting member 21 is used to connect and limit the position of the proximal end of the cardiac valve stent 200 to the support arm 221, thereby preventing the proximal end of the cardiac valve stent 200 from detaching from the support arm 221.

[0036] FIG. 2 is a schematic diagram of a heart valve stent 200 comprising a stent body 201, generally a resiliently compressible mesh structure, having a first release member 202 at its proximal end and a second release member 203 at its distal end.

[0037] As a preferred embodiment, as shown in Figures 3 and 4, the end of the support arm 221 has a position limiting ring 2211, the first release member has a coil 2021 that can pass through the position limiting ring 2211 from the outside to the inside, and the distal end of the position limiting member 21 passes through the inside of the coil 2021, thereby engaging the connection point between the coil 2021 and the position limiting ring 2211 and restricting separation between the coil 2021 and the position limiting ring 2211.

[0038] In a preferred embodiment, the fixing member 22 has multiple support arms 221, the number of the first release members 202 is equal to the number of the support arms 221, and the distal end of the position limiting member 21 may pass through multiple coils 2021 in sequence. For example, in one specific usage situation, the number of the support arms 221 and the second release members are both three, and the distal end of the position limiting member 21 passes through three coils 2021 in sequence. When it is necessary to release the proximal end of the stent body 201, it is pulled out from the three coils 2021, and the coils 2021 are detached from the position limiting rings 2211 due to tension, thereby completing the release of the proximal end of the stent.

[0039] In another preferred embodiment, the number of the support arms 221 and the first releasing members 202 are all three, and the number of the position limiting members 21 is also three. The distal ends of the three position limiting members 21 pass through the three coils 2021 in a one-to-one correspondence. When it is necessary to release the proximal end of the stent body 201, the three position limiting members 21 are pulled and pulled out from the three coils respectively, so as to simultaneously release the three first releasing members 202, thereby ensuring the rapid and stable release of the stent body 201.

[0040] As a removable connection method of the distal end, the fixed block 24 has a position limiting groove 24a, and the first release member 203 has a T-shaped portion 2031 that is engaged with the position limiting groove 24a.

[0041] In some embodiments, the position limiting groove 24a may be an open groove provided along the radial direction of the stent body 201. In this case, the T-shaped portion 2031 is directly engaged with the recess of the open groove from the outer portion of the fixed block 24, and the pressure of the inner wall of the receiving cavity or capsule cavity ensures a stable connection between the position limiting groove 24a and the T-shaped portion 2031. In the case of release, the inner wall of the receiving cavity or capsule cavity 23 no longer covers the opening of the position limiting groove 24a, and the T-shaped portion 2031 opens outward along with the stent body 201 due to the tension of self-expansion, and is released from the position limiting groove 24a. In other embodiments, the insertion groove may be provided along the axial direction, and the opening of the insertion groove is provided toward the proximal end. In this case, the T-shaped portion is inserted into the insertion groove from the end face of the proximal end of the fixed block, and the pressure of the inner wall of the receiving cavity or capsule cavity ensures that the T-shaped portion has a tendency to extend toward the distal end, and is stably inserted into the insertion groove, and when released, the proximal end of the stent body 201 has a tendency to expand due to the tension of its self-expansion, which moves the T-shaped portion out of the insertion groove and separates from the position limiting groove. In this application, the former is preferred.

[0042] Similarly, the above-mentioned removable connection means may also be such that the fixed block 24 has a position limiting protrusion, the first release member has an annular portion which is removably connected to the position limiting protrusion, and the removable connection between the fixed block 24 and the first release member 203 is realized by engaging the annular portion with the position limiting protrusion, and a description thereof will be omitted here.

[0043] In the embodiment of the present application, as shown in Figures 5 and 6, the opening diameter of the capsule cavity 23 is radially expandable, and a guide member 121 is located close to the distal end of the support tube 12, and the guide member 121 can guide the capsule cavity 23 to move into the outer sheath.

[0044] After the artificial valve is released, if the capsule cavity 23 is not accommodated in the outer sheath 14 during the retraction process, the capsule cavity 23 is generally made of stainless steel, which is a hard material, and only the capsule cavity 23 made of a hard material can withstand the tension of the artificial valve, but it is easy to damage the vascular wall in a curved blood vessel when the capsule cavity 23 is retracted. After the delivery device of the present application is used to release the artificial valve in the human heart valve, there is a certain distance between the capsule cavity 23 and the outer sheath 14 and has a certain arc, and after moving relative to each other, the opening of the capsule cavity 23 and the opening of the outer sheath 14 are easy to be misaligned, so if the capsule cavity 23 is not accommodated in the outer sheath 14, the capsule cavity 23 is harder than the outer sheath 14, so it is easy to damage the vascular wall when it encounters a curved blood vessel during the retraction process, and if the opening of the capsule cavity 23 is trumpet-shaped, the risk of damaging the vascular wall is greater. Therefore, the capsule cavity 23 needs to be accommodated in the outer sheath 14. In order to accommodate it more stably, a guide member 121 is designed on the support tube 22 to guide the capsule cavity 23 into the outer sheath 14, thereby ensuring that the capsule cavity 23 is accommodated smoothly and that the operation proceeds smoothly during and after the release, thereby ensuring the efficiency and safety of the operation.

[0045] Specifically, the guide member 121 includes a connection part 1211 and a plurality of guide arms 1212, the connection part 1211 is fixedly connected to the outer wall of the support tube 22, and the guide arms 1212 extend toward the distal end and elastically expand outward. Specifically, in this embodiment, the connection part 1211 is an annular structure fixed to the outer wall of the support tube 22, and six guide arms 1212 uniformly provided in the circumferential direction are connected thereto, and the six guide arms 1212 form a tapered structure on the outside of the support tube 22 with a large opening at the distal end and a small opening at the proximal end.

[0046] The inside of the guide arm 1212 can elastically press against the opening of the capsule cavity 23 to enclose the trumpet-shaped capsule cavity 23, and at the same time, the tapered structure formed on the guide arm 1212 can guide the capsule cavity 23 to be accommodated in the outer sheath 14, making it easier to accommodate the capsule cavity 23 after the artificial valve is attached.

[0047] The distal end of the guide arm 1212 has a transition portion 1213 that is curved toward the axis of the support tube 30 relative to the guide arm 1212, on the one hand to more easily enclose the fence opening 52 and accommodate it within the outer sheath 14, and on the other hand to reduce the outward opening dimension of the guide member 121 and reduce the risk of damaging the heart tissue.

[0048] In order to realize an expandable opening diameter of the capsule cavity 23, in an embodiment of the present application, as shown in FIG. 7 , the capsule cavity 23 includes a cavity body 231 and a fence opening 232, where the cavity body 231 has a straight cylindrical structure and the fence opening 232 is straight cylindrical when no external force is applied. When the artificial valve is released from the capsule cavity 23, the artificial valve gradually opens and widens the fence opening 232 to form a trumpet shape. When retracting, the inner side of the guide arm 322 can elastically press the fence opening 232 to be accommodated in the outer sheath 14.

[0049] The range of change in the outer diameter of the fence opening 232 is 5 mm to 9 mm, which satisfies smooth insertion of the artificial valve and does not affect the operation inside the body when released.

[0050] Specifically, the fence opening 232 has a plurality of axial notches 232a, which are uniformly distributed around the circumferential direction of the capsule cavity 23, and the portions between adjacent axial notches 232a form fence bars 2321, which make the opening end of the capsule cavity 23 prone to become trumpet-shaped during the process of releasing the stent.

[0051] In order to ensure that the fence opening 232 has better deformation performance, the fence opening 232 is further formed with a first long hole 232b and a second long hole 232c, the first long hole 232b is arranged corresponding to the fence bar 2321, the length of the first long hole 232b is greater than the depth of the axial notch 232a, the second long hole 232c is located between two adjacent first long holes 232b, and the second long holes 232b and the axial notches 232a are distributed at an interval in the axial direction.

[0052] Preferably, in this embodiment, the side of the cavity body 231 has a plurality of arc-shaped notches 231a, the arc-shaped notches 231a are distributed along the axial direction of the cavity body 231, and the gap portions between both ends of all the arc-shaped notches 231a are connected to form a connecting rib 2311. By providing the arc-shaped notches 231a, the cavity body 231 has a certain degree of bendability and can further adapt to the complex vascular structure inside the human body.

[0053] In a more preferred embodiment, all the arcuate notches 231a are equal in length, adjacent arcuate notches 231a are staggered, and the connecting rib 2311 is formed spirally along the axial direction. Compared with being linear, the connecting rib 2311 is formed spirally, which can realize the flexible bending of the cavity body 231.

[0054] The cavity body 231 is provided with an arc-shaped notch 231a, and the artificial valve needs to expand along the radial direction during the release process, which is perpendicular to the direction of the arc-shaped notch 231a, so that the resistance force that the artificial valve receives during the release movement process is increased due to the presence of the arc-shaped notch 231a. Therefore, in some more preferred embodiments of the present application, a first thin film protective layer is provided on the inner wall of the cavity body 231, thereby reducing the resistance force of the inner wall of the cavity body 231 against the artificial valve, and a second thin film protective layer is wrapped around the outside of the cavity body 231 and the fence opening 232, and the first thin film protective layer and the second thin film protective layer are elastic thin films, and the elastic restoring force of the first thin film protective layer and the second thin film protective layer can cause the fence opening 232 to contract from the trumpet shape to a straight cylinder shape.

[0055] In another embodiment of the present application, the fence opening 232 can be formed from a material such as a memory alloy, for example a nickel-titanium alloy, allowing the fence opening 232 to shrink from a horn-like shape to a straight cylinder-like shape.

[0056] In the above two contractible embodiments, the fence opening 232 is further limited and can be automatically contracted after being expanded, so that it can be accommodated more conveniently and safely in the outer sheath 14. In actual operation, after the artificial valve is released, the size of the fence opening 232 will be different, that is, in order to make the system more stable, the open size of the guide member 121 needs to accommodate the maximum size of the fence opening 232. In the heart valve, the larger the open size of the guide member 121, the easier it is to damage the heart tissue. Therefore, if the fence opening 232 can be contracted by its own restoring force after being expanded, it can reduce the pressure of the hardware size and can also be accommodated more conveniently and safely in the outer sheath 14.

[0057] To provide control over the delivery system at its proximal end, the delivery system further includes a control handle 30 and two curvature adjustment handles 40, as shown in FIG.

[0058] As shown in Figures 8 to 13, the control handle 30 is connected to the proximal end of the support tube 12 and can move the support tube 12 along the axial direction and further move the capsule cavity 23, and the control handle 30 has a first stroke assembly 34 that controls the axial movement distance of the support tube 12.

[0059] The control handle 30 is arranged along the axial direction of the inner core 11, and in the embodiment of the present application, the control handle 30 includes a handle body sleeve 31, a control sleeve 32, and a control slider 33, and the first stroke assembly 34 includes a first stroke sleeve 341 and a first stroke indicating member 342.

[0060] The handle body sleeve 31 has an axial control slide rail inside, and the control sleeve 32 is screwed inside to slide the control slider 33 along the axial control slide rail. As a preferred connection method, the handle body sleeve 31 has a tubular structure, the control sleeve 32 is fitted on the outer surface of the handle body sleeve 31 and can rotate coaxially outside the handle body sleeve 31, the control sleeve 32 has an inner thread inside and guide grooves on both sides of the axial control slide rail, the control slider 33 is axially mounted on the axial control slide rail, and its outer side extends from the guide groove to screw into the inner thread of the control sleeve 32, and when the control sleeve 32 rotates, it slides the control slider 33 in the axial direction.

[0061] The proximal end of the support tube 12 is fixed to the distal end of the handle body sleeve 21 by a press bolt, and the support tube 11 is inserted from the distal end of the handle body sleeve 21 and fixed to the control slider 23, so that the support tube 12 can be moved axially by axial sliding of the control slider 23.

[0062] The first stroke sleeve 341 is fixedly fitted coaxially on the outside of the control sleeve 32, the first stroke sleeve 341 has a first stroke slide rail, and the outside of the control sleeve 32 is provided with an external thread, and the first stroke indicator 342 is screwed with the external thread of the control sleeve 32, and when the control sleeve 32 rotates, the first stroke indicator 342 slides on the first stroke slide rail, and the thread specifications on both sides of the control sleeve 32 are set to be the same or set as planned, and a stroke scale indicating the moving distance is set on the first stroke slide rail, so that the sliding distance of the control slider 23 can be known by the sliding distance of the first stroke indicator 342 on the first stroke slide rail, and the axial moving distance of the support tube 12 can be accurately controlled. In addition, the present application uses a screw driving method, which has high adjustment accuracy, and can realize stopping and locking at any time at the full stroke, accurately monitor the release process of the valve stent, and reduce the difficulty of releasing the stent.

[0063] To facilitate control at the proximal end of the position limiting member 21, the control handle 30 further includes a detachable member 35, which is removably attached to the proximal end of the handle body sleeve 31 and connected to the proximal end of the position limiting member 21, and when the heart valve stent 200 is located inside the capsule cavity 23, by pulling the position limiting member 21 by the detachable member 35 as described above, the distal end of the position limiting member 21 releases its connection and position limit to the proximal end of the heart valve stent 200 and the support arm 221.

[0064] Two curvature adjustment handles 40 are provided at the proximal end of the inner sheath 13 and the proximal end of the outer sheath 14, respectively, and are used to curve the corresponding distal ends of the inner sheath 13 and the outer sheath 14 in the same plane or different planes using a pull wire 50, and the curvature adjustment handle 40 has a second stroke assembly 47 that controls the curvature of the corresponding inner sheath 13 or outer sheath 14.

[0065] In addition, most of the blood vessels in the human body are curved in three dimensions. In some surgical procedures, the sheath generally needs to enter the femoral artery and then pass through the aortic arch. The blood vessel at this point has a large curvature angle and is curved in three dimensions, which places high demands on the delivery of the heart valve stent. If only one curvature-adjustable sheath that can be bent in a plane is used, it will first bend in one plane when entering the aortic arch, and then bend into another plane due to friction with the blood vessel wall and guiding. Although it is possible to enter the heart in this way, the bending due to large friction with the blood vessel and guiding will easily damage the blood vessel wall, and at the same time, the operation time will be significantly increased and many risks may occur. In addition, when performing interventional surgery, when the doctor operates the control handle to move the sheath inside the human body, only the sheath's development can be displayed on the device, that is, the device cannot see the blood vessel wall, but only the sheath, so that the next bending state of the sheath can only be estimated from the sheath's bending degree, so that when there is stroke control, the sheath's bending degree is directly fed back to the stroke control, and the sheath's bending degree can be accurately controlled by the stroke control. In summary, when the sheath enters a blood vessel with a large bending angle and a three-dimensional bending such as the aortic arch, the combination of double bending adjustment and stroke control is very necessary, so that it can quickly pass through the aortic arch to reach the heart and save time.

[0066] In the embodiment of the present application, the two curvature adjustment handles 40 are arranged in sequence on the side of the control handle 30 adjacent to the distal end of the inner tube 10, and the curvature adjustment handle 40 for adjusting the inner sheath 13 is arranged closer to the control handle 20, thus realizing adjustment of the curvature of each of the inner sheath 13 and the outer sheath 14.

[0067] Specifically, the curvature adjustment handle 40 includes an axial portion a and a branch portion b, the axial portion a is arranged along the axial direction of the inner tube 10, the proximal ends of the inner sheath 13 and the outer sheath 14 are fixed to the corresponding axial portions of the curvature adjustment handle 40, the branch portion b forms an acute angle with the axial portion a, and the axial portion a and the branch portion b form a certain angle, effectively shortening the length of the entire delivery system, the second stroke assembly is arranged at the branch portion b, and the curvature of the branch portion b and the curvature of the corresponding sheath are within the same curvature arc, so that it can have a guiding effect during curvature adjustment, and in the second stroke assembly, when a straight stroke changes into a curvature adjustment arc, it is more stable, and no large curvature adjustment movement occurs in some strokes, improving the stability of the device.

[0068] The axial portion a includes an axial sleeve 41, a hemostasis valve 42, and a proximal end fixing cover 43, and has an axial through hole inside the axial sleeve 41, the proximal ends of the inner sheath 13 and the outer sheath 14 are inserted from the distal ends of the corresponding axial sleeve 41 and locked and fixed, the axial sleeve 41 has a lateral wire hole 411 corresponding to the branch portion b, the hemostasis valve 42 is provided at a position adjacent to the proximal end of the axial sleeve 41 and has an elastically contractible hemostasis channel, and the proximal end fixing cover 43 is fixed to the proximal end of the axial sleeve 41 and has a duct through hole.

[0069] The hemostasis valve 42 is mainly used to prevent blood from leaking from the sheath due to blood pressure when the sheath enters a blood vessel. In the present embodiment, the hemostasis valve 42 includes at least one valve group 420. In the present preferred embodiment, the hemostasis valve 42 includes two valve groups 420 arranged along the axial direction.

[0070] The valve group 420 includes a valve sleeve 421, and a first valve 422, a second valve 423, and a third valve 424, which are coaxially arranged from the proximal end to the distal end in that order. A first hole is formed in the central part of the first valve 422, and non-penetrating notches are formed on both sides of the first valve 422, and the notches on both sides are arranged alternately. In the present application, a cross groove is formed on both sides, and the two cross grooves are arranged with a 45 degree shift, which can effectively improve the axial protrusion of the central part of the first valve 422 to both sides. The central portion of the second valve 423 protrudes to the distal end, and a second hole is formed at its center position. An annular step 4231 is formed on the side of the second valve 423 close to the third valve 424. The third valve 424 includes an elastic tube 4241 and two elastic valves 4242, the elastic valve 4242 is connected to the inner wall of the elastic tube 4241, the distal ends of the two elastic valves 4242 form an openable and closable valve port, the distal end of the elastic valve 4242 and the inner wall of the elastic tube 4241 have an elastic support rib 4243 that elastically closes the valve port, the annular step 4231 is incorporated in the proximal end opening of the elastic tube 4241, the valve sleeve 421 is a cylindrical member, and the elastic tube 4241 is partially or completely incorporated in the valve sleeve 421, and the first hole, the second hole and the valve port constitute a hemostasis channel. With the above structure, when the valve group 420 and the inner tube 10 or inner sheath 13 contained therein move relative to each other, the central portions of the second valve 423 and the third valve 424 protrude in the axial direction due to frictional force, thereby effectively preventing blood leakage.

[0071] In the embodiment of the present application, the branch portion b includes a branch body 44, a curvature adjustment slider 45, and a curvature adjustment sleeve 46, the second stroke assembly 47 includes a second stroke sleeve 471 and a second stroke indicating member 472, the branch body 44 includes an axial fixing tube 441 and a guide tube 442 that are arranged in communication with each other, the axial fixing tube 441 is coaxially fixed to the outside of the axial sleeve 41, the guide tube 442 is arranged corresponding to the lateral wire hole, the guide tube 442 extends toward the proximal end and is arranged to form a predetermined acute angle with the axial fixing tube 441, the inside of the guide tube 442 has a curvature adjustment guide slide rail along its axial direction, and the proximal end of the traction wire 50 is fixed to the curvature adjustment slider 45. The principle of curvature adjustment is to linearly move the curvature adjustment slider 45 by the curvature adjustment sleeve 46, and further move the proximal end of the pulling wire to pull and bend the corresponding distal end of the inner sheath 13 or outer sheath 14. The connection between the curvature adjustment slider 45 and the curvature adjustment sleeve 46 is similar to that of the control sleeve 32 and the control slider 33, that is, the inside of the curvature adjustment sleeve 46 is screwed to slide the curvature adjustment slider 45 along the curvature adjustment guide slide rail.

[0072] The second stroke sleeve 471 is fixedly fitted to the outside of the curvature adjustment sleeve 46, the second stroke sleeve 471 has a second stroke slide rail, and the outside of the curvature adjustment sleeve 46 slides the second stroke instruction member 472 along the second stroke slide rail by screwing it.

[0073] The second stroke indicator member 472 can be determined by observing the distance traveled or the screw distance traveled, or can be determined by setting specific stroke scales on the surface of the second stroke sleeve 471, and further adjusts the travel distance of the proximal end of the puller wire, thereby achieving precise control over the curvature of the inner sheath 13 or the outer sheath 14.

[0074] In the aortic valve delivery system of the present application, the support tube 12 is moved axially by the control handle 30, and the two curvature adjustment handles 40 bend the distal ends of the inner sheath 13 and the outer sheath 14 by corresponding puller wires 50. The control handle 20 is provided with a first stroke assembly 24 to accurately control the axial movement distance of the support tube 11, and the curvature adjustment handle 40 is provided with a second stroke assembly 47 to control the degree of curvature of the sheaths, thereby providing better control over the curvature adjustment and release of the artificial valve.

[0075] The above are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

Claims

1. a delivery catheter assembly and a stent fixation assembly, The delivery catheter assembly includes a movable inner core, a support tube, an inner sheath, and an outer sheath, which are fitted in this order from the inside to the outside, and both ends of the inner core extend from both ends of the support tube, respectively, and a distal end of the inner sheath has a receiving cavity; 13. An interventional heart valve stent delivery system, comprising: a stent fixation assembly removably connectable to both ends of a heart valve stent; and a stent fixation assembly including a capsule cavity, a distal end of the inner core being inserted through an opening at a proximal end of the capsule cavity and fixedly connected to the capsule cavity, and a support tube capable of axially moving the heart valve stent in and out of the capsule cavity or receiving cavity.

2. The stent fixation assembly further includes a fixation member, a fixation block, and a position limiting member; the fixation member has a support arm connected to the support tube and extending to a distal end thereof, the fixation block is connected to the distal end of the support tube, the support arm and the fixation block being configured to be removably connected to a proximal end and a distal end of a heart valve stent, respectively; 2. The interventional heart valve stent delivery system of claim 1, wherein the position limiting member is a thin, elongated structure that can axially penetrate the support tube and extend from both ends of the support tube, and the distal end of the position limiting member is used to connect and limit the position of the proximal end of the heart valve stent to the support arm so as to prevent the proximal end of the heart valve stent from detaching from the support arm.

3. 2. The interventional heart valve stent delivery system of claim 1, wherein the opening diameter of the capsule cavity is radially expandable, and a guide member is located adjacent to the distal end of the support tube, and the guide member can guide the capsule cavity and move into the outer sheath.

4. 4. The interventional heart valve stent delivery system of claim 3, wherein the guide member includes a connecting portion and a plurality of guide arms, the connecting portion being fixedly connected to an outer wall of the support tube, and the guide arms extending toward a distal end and elastically expanding outward.

5. 5. The interventional heart valve stent delivery system of claim 4, wherein the distal end of the guide arm has a transition portion, the transition portion curving toward a side proximal to the axis of the support tube relative to the guide arm.

6. 4. The interventional heart valve stent delivery system of claim 3, wherein the capsule cavity includes a cavity body and a fence opening, the cavity body has a straight cylindrical structure, the fence opening is straight cylindrical when no external force is applied, and can expand into a trumpet shape when an external force is applied, and the inner side of the guide arm can elastically press the fence opening.

7. 7. The interventional heart valve stent delivery system of claim 6, wherein the fence opening has a plurality of axial notches, the axial notches being uniformly distributed circumferentially around the capsule cavity, and the portions between adjacent axial notches defining fence rungs.

8. The interventional heart valve stent delivery system of claim 6, characterized in that the side of the cavity body has a plurality of arcuate notches of equal length, the arcuate notches are distributed along the axial direction of the cavity body, adjacent arcuate notches are offset, and the gaps between both ends of all the arcuate notches are connected to form a connecting rib that is spiral along the axial direction.

9. 2. The interventional heart valve stent delivery system of claim 1, further comprising a control handle and two curvature adjustment handles, the control handle being connected to a proximal end of the support tube and capable of moving the support tube along an axial direction, the control handle having a first stroke assembly for controlling the axial movement distance of the support tube, the two curvature adjustment handles being provided at the proximal end of the inner sheath and the proximal end of the outer sheath, respectively, and bending the corresponding distal end of the inner sheath and the distal end of the outer sheath in the same plane or in different planes by a puller wire, and the curvature adjustment handle having a second stroke assembly for controlling the curvature degree of the corresponding inner sheath or the outer sheath.

10. 10. The interventional heart valve stent delivery system of claim 9, wherein the control handle is arranged along the axial direction of the support tube, the two curvature adjustment handles are arranged in sequence on the side of the control handle close to the distal end of the support tube, the curvature adjustment handle for adjusting the inner sheath is arranged closer to the control handle, the curvature adjustment handle includes an axial portion and a branched portion, the axial portion is arranged along the axial direction of the support tube, the proximal ends of the inner sheath and the outer sheath are fixed to the corresponding axial portion of the curvature adjustment handle, the branched portion forms an acute angle with the axial portion, and the second stroke assembly is arranged at the branched portion.

11. The control handle includes a handle body sleeve, a control sleeve, and a control slider, the first stroke assembly includes a first stroke sleeve and a first stroke indicating member, and has an axial control slide rail inside the handle body sleeve, the inside of the control sleeve slides the control slider along the axial control slide rail by screwing, the support tube is fixed to the distal end of the handle body sleeve, the support tube is inserted from the distal end of the handle body sleeve and fixed to the control slider, the first stroke sleeve is fixedly fitted to the outside of the control sleeve, the first stroke sleeve has a first stroke slide rail arranged along the axial direction, and the outside of the control sleeve slides the first stroke indicating member along the first stroke slide rail by screwing.

12. The interventional heart valve stent delivery system of claim 11, characterized in that the control handle further includes a detachable member, the detachable member being removably attached to the proximal end of the handle body sleeve and connected to the proximal end of the position limiting member, and when the heart valve stent is positioned inside the capsule cavity, the detachable member pulls the position limiting member, thereby releasing the connection and position limit of the distal end of the position limiting member to the proximal end of the heart valve stent and the support arm.

13. The interventional heart valve stent delivery system of claim 11, characterized in that the axial portion includes an axial sleeve, a hemostasis valve, and a proximal end fixing cover, the axial sleeve has an axial through hole therein, the proximal ends of the inner sheath and the outer sheath are inserted and fixed from the corresponding distal ends of the axial sleeve, the axial sleeve has a transverse wire hole corresponding to the branched portion, the hemostasis valve is provided at a position adjacent to the proximal end of the axial sleeve and has an elastically contractible hemostasis channel, and the proximal end fixing cover is fixed to the proximal end of the axial sleeve and has a duct through hole.

14. The hemostatic valve includes at least one valve group, the valve group including a valve sleeve and a first valve, a second valve, and a third valve arranged coaxially in order from a proximal end to a distal end, the first valve has a first hole formed in a central portion thereof, the first valve has notches formed on both sides thereof that do not penetrate, and the notches on both sides are alternately arranged, the second valve has a central portion protruding toward the distal end and a second hole formed in its central position, the second valve has an annular step formed on a side adjacent to the third valve, and the third valve has an elastic tube and two 14. The interventional heart valve stent delivery system of claim 13, further comprising: an elastic valve, the elastic valve being connected to an inner wall of the elastic tube; the distal ends of the two elastic valves forming an openable and closable valve orifice; the distal ends of the elastic valves and the inner wall of the elastic tube having an elastic support rib for elastically closing the valve orifice; the annular step being embedded in the proximal end opening of the elastic tube; the valve sleeve being a cylindrical member, the elastic tube being partially or completely embedded in the valve sleeve; and the first hole, the second hole and the valve orifice constituting the hemostasis channel.

15. The branched portion includes a branched body, a curvature adjustment slider, and a curvature adjustment sleeve, the second stroke assembly includes a second stroke sleeve and a second stroke indicating member, the branched body includes an axial fixing tube and a guide tube provided in communication with each other, the axial fixing tube is fixed coaxially to the outside of the axial sleeve, the guide tube is provided corresponding to the transverse wire hole, the guide tube extends toward the proximal end, and is provided to form a predetermined acute angle with the axial fixing tube, and a curvature adjustment guide slide rail is provided inside the guide tube along its axial direction.

14. The interventional heart valve stent delivery system of claim 13, wherein the proximal end of the puller wire is fixed to the curvature adjustment slider, the inside of the curvature adjustment sleeve slides the curvature adjustment slider along the curvature adjustment guide slide rail by screwing, the second stroke sleeve is fixedly fitted to the outside of the curvature adjustment sleeve, the second stroke sleeve has a second stroke slide rail, and the outside of the curvature adjustment sleeve slides the second stroke indicator member along the second stroke slide rail by screwing.

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