Aortic valve delivery system with a variable-diameter capsule cavity

Abstract

The present invention relates to an aortic valve delivery system with a variable-diameter capsule cavity, comprising an outer sheath tube, an inner sheath tube, a support tube, an inner tube and a capsule cavity; the outer sheath tube is movably sleeved on the outside of the inner sheath tube, the inner sheath tube is movably sleeved on the outside of the support tube, and the distal end of the support tube has a connector connected to the distal end of an artificial valve; the inner tube is movably inserted into the support tube, the distal end of the inner tube extends from an opening at the proximal end of the capsule cavity and is fixedly connected to the capsule cavity, the support tube can drive the connector to move axially to allow the artificial valve to extend into the capsule cavity or detach from the capsule cavity, the opening diameter of the capsule cavity can expand radially, and the support tube has a guide member near the distal end, the guide member is used to limit the radial expansion of the opening of the capsule cavity so that the distal end of the outer sheath tube can smoothly accommodate the capsule cavity, thereby solving the technical problem in the prior art that the stent cannot be smoothly released due to excessive resistance when moving axially along the delivery system.

Description

Technical Field

[0001] The present invention relates to the technical field of transcatheter aortic valve implantation equipment, and in particular to an aortic valve delivery system with a variable-diameter capsule cavity. Background Art

[0002] With the aging of the population, the incidence of valvular heart disease has increased significantly. According to the statistical analysis of the echocardiography database of hospital patients, in patients aged 65-74 years (49,995 cases) and ≥75 years (34,671 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. The detection rates of severe aortic regurgitation (SAR) and severe aortic stenosis (SAS) in the two groups were 0.52% vs. 0.95% and 0.54% vs. 0.57%, respectively.

[0003] Currently, traditional surgical treatment remains the preferred treatment for most patients with severe valvular disease, but it carries risks such as significant trauma, postoperative mortality, and high complications. In recent years, transcatheter valve implantation / repair has matured and become widely used. In particular, transcatheter aortic valve implantation (TAVR / TAVI) has a strong evidence-based foundation, significantly reduces trauma, and is recommended by European and American valvular disease treatment guidelines, representing a milestone in the field of interventional treatment for valvular heart disease.

[0004] Transcatheter aortic valve implantation (TAVI) is a new technology that uses an interventional method to insert an artificial aortic valve. It was first reported and used by Dr. Criber in France in 2002. It has brought hope for the treatment of patients with severe aortic stenosis (AS) who have lost the opportunity for surgical treatment (such as those over 80 years old), and has also opened a new chapter in the history of interventional treatment of cardiovascular diseases.

[0005] Over the next decade, with advancements in equipment and accumulated experience, TAVI technology has continued to improve. It has been implemented in over 500 cardiac centers in nearly 40 countries, with over 150,000 procedures performed. In particular, after a series of registries and randomized controlled trials demonstrating its effectiveness, feasibility, and safety, TAVI has become the treatment of choice for patients with severe AS who are unable to undergo surgical valve replacement. Clinically, the two main bioprosthetic valves used for TAVI are the balloon-expandable Edwards Sapien (Edwards, Inc., USA) and the self-expanding CoreValve (Medtronic, Inc., USA). TAVI technology has made remarkable progress internationally and has been initially applied in my country, with equally broad prospects. Currently, the domestic heart valve device market is a market highly monopolized by foreign brands. Foreign companies such as Edwards Lifesciences, Medtronic, LivaNova, St. Jude Medical and On-X account for approximately 85% of the market share. Among them, Edwards Lifesciences and Medtronic have a full product pipeline from mechanical valves, biological valves to transcatheter interventional valves. A number of domestic device companies have also emerged in China. Currently, three domestically produced transcatheter aortic valves have been approved by China's CFDA for listing, but domestic companies do not yet have a leading advantage in this field.

[0006] In short, transcatheter aortic valve implantation is a surgical procedure that uses a delivery system to deliver the aortic valve to a predetermined position in the body and then releases it. Current delivery systems all load the stent into the capsule cavity and then release the stent to the appropriate position through a remote handle. When the delivery system of the existing technology is ready to release the stent, the stent is loaded into the capsule cavity in a compressed manner, and the stent will have a large tension in the capsule cavity. As a result, when the delivery system is in operation, when the stent needs to move along the axial direction of the delivery system, it will generate large resistance. Therefore, it is very difficult for the doctor to operate the handle to release the stent, resulting in the stent being unable to be released from the capsule cavity, seriously affecting the operation and even endangering the patient's life. Summary of the Invention

[0007] Based on the above description, the present invention provides an aortic valve delivery system with a variable diameter capsule cavity to solve the technical problem in the prior art that the stent cannot be released smoothly due to excessive resistance when moving axially along the delivery system.

[0008] The technical solution of the present invention to solve the above technical problems is as follows:

[0009] An aortic valve delivery system with a variable-diameter capsule cavity, comprising an outer sheath tube, an inner sheath tube, a support tube, an inner tube, and a capsule cavity;

[0010] The outer sheath tube is movably sleeved on the outside of the inner sheath tube, and the inner sheath tube is movably sleeved on the outside of the support tube. The distal end of the support tube has a connector connected to the distal end of the artificial valve;

[0011] The inner tube is movably inserted into the support tube, and the distal end of the inner tube extends from the opening at the proximal end of the capsule cavity and is fixedly connected to the capsule cavity. The support tube can drive the connecting piece to move axially so that the artificial valve extends into the capsule cavity or detaches from the capsule cavity. The opening diameter of the capsule cavity can expand radially. The support tube has a guide piece near the distal end, and the guide piece is used to limit the radial expansion of the opening of the capsule cavity so that the distal end of the outer sheath tube can smoothly accommodate the capsule cavity.

[0012] Compared with the prior art, the technical solution of this application has the following beneficial technical effects:

[0013] The aortic valve delivery system with a variable diameter capsule cavity provided in the present application, when released, alleviates the resistance encountered by the artificial valve during the release process by expanding the caliber of the capsule cavity opening, making the artificial valve easier to release. After the artificial valve is released, the capsule cavity needs to be retracted into the outer sheath tube during the retraction process, and the radially expanded opening may cause the outer sheath tube and the capsule cavity to be misaligned, making it difficult to retract the capsule cavity into the outer sheath tube. Therefore, a guide is designed on the support tube to limit the radial expansion of the capsule cavity opening, and at the same time guide the retraction of the capsule cavity into the outer sheath tube, ensuring the smooth retraction of the capsule cavity, and then ensuring that the loading and release processes can proceed smoothly, ensuring the efficiency and stability of the operation.

[0014] On the basis of the above technical solution, the present invention can also be improved as follows.

[0015] Furthermore, the guide member includes a connecting portion and a plurality of guide arms, the connecting portion is fixedly connected to the outer wall of the support tube, and the guide arms extend toward the distal end and elastically expand outward.

[0016] Furthermore, the distal end of the guide arm has a transition portion, and the transition portion is bent relative to the guide arm toward a side close to the axis of the support tube.

[0017] Furthermore, the capsule cavity includes a cavity body and a fence opening. The cavity body is a straight cylindrical structure. The fence opening is straight cylindrical without external force and can expand into a trumpet shape under external force. The inner side of the guide arm can elastically press the fence opening.

[0018] Furthermore, the outer diameter of the fence opening ranges from 5mm to 9mm.

[0019] Furthermore, the fence opening has a plurality of axial cuts, and the axial cuts are evenly distributed around the capsule cavity, and the portions between adjacent axial cuts constitute fence bars.

[0020] Furthermore, the side surface of the cavity body has a plurality of arc-shaped cutouts, and the arc-shaped cutouts are distributed along the axial direction of the cavity body, and the gaps between the two ends of all the arc-shaped cutouts are partially connected to form connecting ribs.

[0021] Furthermore, all the arc-shaped cuts are of equal length, adjacent arc-shaped cuts are staggered, and the connecting ribs are spiral along the axial direction.

[0022] Furthermore, the inner side wall of the cavity body is provided with a first thin film protective layer, and the outer side of the cavity body and the fence opening is covered with a second thin film protective layer, and the first thin film protective layer and the second thin film protective layer are elastic films.

[0023] Furthermore, the fence opening is made of nickel-titanium alloy. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 A schematic structural diagram of an aortic valve delivery system with a variable-diameter capsule cavity provided by an embodiment of the present invention;

[0025] Figure 2 for Figure 1 A magnified schematic diagram of area A in the middle;

[0026] Figure 3 Schematic diagram of the matching relationship between the guide member and the capsule cavity in an embodiment of the present invention;

[0027] Figure 4 Schematic diagram of the structure of the capsule cavity according to an embodiment of the present invention. DETAILED DESCRIPTION

[0028] To facilitate understanding of the present application, the present application will be described more fully below with reference to the accompanying drawings. The accompanying drawings provide embodiments of the present application. However, the present application may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to make the disclosure of the present application more thorough and comprehensive.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application.

[0030] It will be understood that spatial relational terms such as "under", "beneath", "below", "under", "above", "above", etc., may be used herein to describe the relationship of an element or feature shown in the figures to other elements or features. It will be understood that in addition to the orientations shown in the figures, spatial relational terms also include different orientations of the device in use and operation. For example, if the device in the drawings is turned over, the element or feature described as "under the other elements" or "under it" or "below it" will be oriented as "on" the other elements or features. Therefore, the exemplary terms "under" and "under" may include both upper and lower orientations. In addition, the device may also include alternative orientations (e.g., rotated 90° or other orientations), and the spatial descriptors used herein are interpreted accordingly.

[0031] It should be noted that when an element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediate element. In the following embodiments, "connection" should be understood as "electrical connection", "communication connection", etc., if the connected circuits, modules, units, etc. can transmit electrical signals or data to each other.

[0032] As used herein, the singular forms "a", "an", and "the" may also include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the terms "include", "comprising", "having", etc. specify the presence of stated features, integers, steps, operations, components, parts, or combinations thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, components, parts, or combinations thereof.

[0033] like Figure 1 and Figure 2 As shown, the present application provides an aortic valve delivery system with a variable-diameter capsule cavity, which includes an outer sheath tube 10 , an inner sheath tube 20 , a support tube 30 , an inner tube 40 and a capsule cavity 50 .

[0034] The outer sheath 10 is movably mounted on the outside of the inner sheath 20, and the inner sheath 20 is movably mounted on the outside of the support tube 30. The distal end of the support tube 30 has a connector 31 connected to the distal end of the artificial valve. It is understood that, similar to conventional delivery, the outer sheath 10 and the inner sheath 20 have operating devices at the proximal end close to the operator (such as a doctor) that can achieve bending and axial driving. Figure 1 The first bending handle 101 and the second bending handle 201 are configured to achieve bending and axial movement respectively.

[0035] The inner tube 40 is movably inserted into the support tube 30, and the distal end of the inner tube 40 extends from the opening at the proximal end of the capsule cavity 50 and is fixedly connected to the capsule cavity 50, so that the inner tube 40 can move axially inside the support tube. Since there is a connecting piece 31 at the distal end of the support tube 30, the distal end of the artificial valve is fixed by the connecting piece 31, and the support tube 30 is axially slid, which can drive the connecting piece 31 to move axially so that the artificial valve extends into the capsule cavity 50 or detaches from the capsule cavity 50, which is the loading and release of the artificial valve.

[0036] In this embodiment, the opening diameter of the capsule cavity 50 can be expanded radially to alleviate the resistance encountered by the artificial valve during the release process, making it easier to release the artificial valve.

[0037] The support tube 30 has a guide member 32 near the distal end. The guide member 32 is used to limit the radial expansion of the opening of the capsule cavity 50 so that the distal end of the outer sheath tube 10 can smoothly accommodate the capsule cavity 50.

[0038] After the artificial valve is released, during the withdrawal process, if the capsule cavity 50 is not retracted into the outer sheath tube 10, since the capsule cavity 50 is generally made of stainless steel, which is relatively hard, only the capsule cavity 50 made of relatively hard material can withstand the tension of the artificial valve, but the capsule cavity 50 is easy to scratch the blood vessel wall in the curved blood vessel when withdrawing. After the artificial valve is released at the human heart valve by using the delivery device of the present application, there is a certain distance between the capsule cavity 50 and the outer sheath tube 10, and the distance has a certain curvature. After relative movement, the opening of the capsule cavity 50 and the opening of the outer sheath tube 10 are easily misaligned, resulting in The capsule cavity 50 cannot enter the outer sheath tube 10. If it is not retracted, since the capsule cavity 50 is harder than the outer sheath tube 10, it is easy to scratch the blood vessel wall when encountering a curved blood vessel during the retraction process. When the capsule cavity 50 opens in a trumpet shape, the risk of scratching the blood vessel wall is greater. Therefore, it is necessary to retract the capsule cavity 50 into the outer sheath tube 10. In order to achieve more stable retraction, a guide member 32 is designed on the support tube 30 to guide the capsule cavity 50 to be retracted into the outer sheath tube 10, thereby ensuring the smooth retraction of the capsule cavity 50, and then ensuring that the operation can be carried out smoothly during and after the release process, ensuring the efficiency and stability of the operation.

[0039] Among them, Figure 3 As shown, the guide member 32 includes a connecting portion 321 and a plurality of guide arms 322. The connecting portion 321 is fixedly connected to the outer wall of the support tube 30, and the guide arms 322 extend toward the distal end and elastically expand outward. Specifically, in this embodiment, the connecting portion 321 is an annular structure fixed on the outer wall of the support tube 30, and is connected to 6 guide arms 322 evenly arranged in the circumferential direction. The 6 guide arms 322 form a conical structure on the outside of the support tube 30 with a large distal opening and a small proximal opening.

[0040] The inner side of the guide arm 322 can elastically press the opening of the capsule cavity 50 and thus wrap the trumpet-shaped capsule cavity 50. At the same time, the cone formed by the guide arm 322 can guide the outer sheath tube 10 to retract the capsule cavity 50, thereby facilitating the retraction of the capsule cavity 50 after the artificial valve is loaded.

[0041] The distal end of the guide arm 322 has a transition portion 323, which is bent relative to the guide arm 322 toward the axis of the support tube 30. On the one hand, this is to make it easier to cover the fence opening 52 and retract it into the outer sheath 10. On the other hand, it makes the outward opening size of the guide member 32 smaller, reducing the risk of scratching the heart tissue.

[0042] In order to realize the expandability of the opening diameter of the capsule cavity 50, in the embodiment of the present application, Figure 4 As shown, the capsule cavity 50 includes a cavity body 51 and a fence opening 52. The cavity body 51 is a straight cylindrical structure, and the fence opening 52 is straight cylindrical when there is no external force. When the artificial valve is released from the capsule cavity 50, the artificial valve will slowly open, and the fence opening 52 will be stretched to form a trumpet shape. When retracting, the inner side of the guide arm 322 can elastically press the fence opening 52 and retract it into the outer sheath 10.

[0043] The outer diameter of the fence opening 52 varies in the range of 5 mm to 9 mm, which can ensure smooth placement of the artificial valve without affecting the in vivo operation during release.

[0044] Specifically, the fence opening portion 52 has multiple axial cuts 52a, which are evenly distributed around the capsule cavity 50. The parts between adjacent axial cuts 52a constitute fence bars 521, which make the opening end of the capsule cavity 50 easily become a trumpet-mouth state during the release of the bracket.

[0045] In order to ensure that the fence opening 52 has better deformation performance, the fence opening 52 is also provided with a first strip hole 52b and a second strip hole 52c. The first strip hole 52b is arranged corresponding to the fence bar 521. The length of the first strip hole 52b is greater than the depth of the axial cut 52a. The second strip hole 52c is located between two adjacent first strip holes 52b, and the second strip hole 52b and the axial cut 52a are spaced apart in the axial direction.

[0046] Preferably, in this embodiment, the side of the cavity body 51 has several arc-shaped cuts 51a, and the arc-shaped cuts 51a are distributed along the axial direction of the cavity body 51. The gaps between the two ends of all the arc-shaped cuts 51a are connected to form connecting ribs 511. The setting of the arc-shaped cuts 51a can make the cavity body 51 have a certain degree of flexibility, thereby adapting to the complex and changeable vascular structure inside the human body.

[0047] In a more preferred embodiment, all arcuate cuts 51a are of equal length, adjacent arcuate cuts 51a are staggered, and the connecting ribs 511 are spiral along the axial direction. Compared with the straight line, the spiral connecting ribs 511 can realize universal bending of the cavity body 51.

[0048] Since an arc-shaped incision 51a is provided on the cavity body 51, the artificial valve needs to expand radially during the release process, which is perpendicular to the direction of the arc-shaped incision 51a. Therefore, the artificial valve will increase resistance during the release movement due to the existence of the arc-shaped incision 51a. Therefore, in this embodiment, the inner wall of the cavity body 51 is provided with a first thin film protective layer to reduce the resistance of the inner wall of the cavity body 51 to the artificial valve, and the outer side of the cavity body 51 and the fence opening 52 is covered with a second thin film protective layer. The first thin film protective layer and the second thin film protective layer are elastic thin films. Under the elastic restoring force of the first thin film protective layer and the second thin film protective layer, the fence opening 52 is retracted from a trumpet shape and can even become a straight cylinder.

[0049] In other embodiments of the present application, the fence opening 52 can be formed of a memory alloy, such as a nickel-titanium alloy, so that the fence opening 52 can be retracted from a trumpet shape and can even become a straight cylinder.

[0050] The above two retractable embodiments further limit the fence opening 52, so that the fence opening 52 can automatically retract after expansion, in order to be more convenient and safer to be received into the outer sheath 10. Because in actual operation, after the artificial valve is released, the size of the fence opening 52 is different. That is to say, in order to make the system more stable, the size of the guide 32 must be able to accommodate the maximum size of the fence opening 52. At the heart valve, the larger the size of the guide 32 is, the easier it is to scratch the heart tissue. Therefore, if the fence opening 52 can retract under its own restoring force after expansion, it can reduce the hardware size pressure, and it can also be more convenient and safer to be received into the outer sheath 10.

[0051] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. An aortic valve delivery system with a variable diameter capsule cavity, characterized in that: It includes an outer sheath, an inner sheath, a support tube, an inner tube and a capsule cavity; The outer sheath tube is movably sleeved on the outside of the inner sheath tube, and the inner sheath tube is movably sleeved on the outside of the support tube. The distal end of the support tube has a connector connected to the distal end of the artificial valve; The inner tube is movably inserted into the support tube, and the distal end of the inner tube extends from the opening at the proximal end of the capsule cavity and is fixedly connected to the capsule cavity. The support tube can drive the connecting piece to move axially so that the artificial valve extends into or detaches from the capsule cavity. The support tube has a guide piece near the distal end; The guide member includes a connecting part and a plurality of guide arms, the connecting part is an annular structure fixed on the outer wall of the support tube, the annular structure has the plurality of guide arms uniformly fixedly connected in a circumferential direction, the guide arms extend toward the distal end and elastically expand outward, and the plurality of guide arms form a conical structure with a large distal opening and a small proximal opening on the outside of the support tube, the capsule cavity includes a cavity body and a fence opening, the cavity body is a straight cylindrical structure, and the fence opening is straight cylindrical without external force, when the artificial valve is released from the capsule cavity, the artificial valve will slowly open, causing the fence opening to expand and form a trumpet shape, and when withdrawn, the inner side of the guide arm elastically presses the fence opening, causing the fence opening to retract from the trumpet shape, thereby guiding the capsule cavity to move into the outer sheath tube.

2. The aortic valve delivery system with a variable diameter capsule cavity according to claim 1, characterized in that: The distal end of the guide arm has a transition portion, and the transition portion is bent relative to the guide arm toward a side close to the axis of the support tube.

3. The aortic valve delivery system with a variable diameter capsule cavity according to claim 1, characterized in that: The outer diameter of the fence opening varies in the range of 5mm-9mm.

4. The aortic valve delivery system with a variable diameter capsule cavity according to claim 1, characterized in that: The fence opening has a plurality of axial cuts, and the axial cuts are evenly distributed around the capsule cavity, and the portions between adjacent axial cuts constitute fence bars.

5. The aortic valve delivery system with a variable diameter capsule cavity according to claim 3, characterized in that: The side surface of the cavity body is provided with a plurality of arc-shaped cutouts, and the arc-shaped cutouts are distributed along the axial direction of the cavity body, and the gaps between the two ends of all the arc-shaped cutouts are partially connected to form connecting ribs.

6. The aortic valve delivery system with a variable diameter capsule cavity according to claim 5, characterized in that: All the arc-shaped cuts are of equal length, adjacent arc-shaped cuts are staggered, and the connecting ribs are spiral along the axial direction.

7. The aortic valve delivery system with a variable diameter capsule cavity according to claim 4, characterized in that: The inner side wall of the cavity body is provided with a first thin film protective layer, and the outer sides of the cavity body and the fence opening are covered with a second thin film protective layer. The first thin film protective layer and the second thin film protective layer are elastic films.

8. The aortic valve delivery system with a variable diameter capsule cavity according to claim 4, characterized in that: The fence opening is made of nickel-titanium alloy.

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