Loading body, loading device and delivery system for housing a valve prosthesis
By designing a movable carrier structure, the problem of scratch risk caused by the large axial dimension of existing delivery devices is solved, realizing convenient operation and adaptability, and reducing the risk of valve prosthesis displacement.
Patent Information
- Application Number
- CN202410770334.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-06-14
- Publication Date
- 2026-11-06
- Estimated Expiration
- 2044-06-14
AI Technical Summary
The existing delivery system has a large axial dimension in the loading section for loading artificial valves, which increases the risk of scraping the implanted heart valve during the cross-valve operation after the heart valve prosthesis is released.
A loading device was designed, comprising two relatively movable loading parts. The movement of the loading parts is controlled by an adjustment component to shorten the axial length, facilitating the retraction and adaptation to valve prostheses of different sizes and reducing the risk of scratches.
It improves ease of operation, reduces the risk of scratching during valve prosthesis withdrawal, and can adapt to different sizes of valve prostheses, enhancing adaptability and stability.
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Figure CN118593192B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and more specifically, to an interventional artificial heart valve delivery system and its components. Background Technology
[0002] Heart valve disease is one of the most common heart diseases in my country, with valvular damage mainly caused by rheumatic fever. In recent years, with the aging of the population, valvular degeneration (including calcification and myxoid degeneration) and metabolic valvular damage have also been increasing in my country. At present, implanting a heart valve prosthesis through minimally invasive medical surgery provides medical staff with a new treatment method that is less invasive, has fewer complications, and allows for faster postoperative recovery.
[0003] During valve treatment, a delivery device is needed to transport, control, and release the prosthetic heart valve. However, the axial dimension of the loading part of the existing delivery device used to load the artificial valve is relatively large. After the prosthetic heart valve is released, when the delivery device is withdrawn during the cross-valve operation, there is a high risk of scraping the implanted prosthetic heart valve and causing displacement. Summary of the Invention
[0004] The technical problem to be solved by this application is to provide a carrier, loading device and delivery system for accommodating valve prostheses that improves the ease of operation.
[0005] To solve the above-mentioned technical problems, this application adopts the following technical solution:
[0006] In a first aspect, this application provides a carrier for accommodating a heart valve prosthesis, comprising: two loading portions, the two loading portions being movable away from each other to release the valve prosthesis, and one of the loading portions being insertable into the chamber of the other loading portion after the valve prosthesis is released, to shorten the axial length of the carrier.
[0007] In one embodiment, the two loading portions include a first loading portion located at the distal end and a second loading portion located at the proximal end, wherein the radial dimension of the distal end of the second loading portion does not exceed the inner diameter dimension of the first loading portion.
[0008] In one embodiment, the first loading section includes a connecting post located at the distal end for connection with the adjustment assembly.
[0009] In one embodiment, the second loading part includes a protrusion located at the proximal end for connection with the first connector.
[0010] Secondly, this application provides a loading device, including the loading carrier for accommodating a valve prosthesis provided in the first aspect; and an adjustment assembly connected to a first loading part, the adjustment assembly being capable of controlling the movement of the first loading part relative to a second loading part.
[0011] In one embodiment, the adjustment assembly includes a support member connected to the distal end of the first loading portion, the support member being used to control the movement of the first loading portion relative to the second loading portion.
[0012] In one embodiment, the distal end of the first loading part is provided with a positioning groove, the adjustment component includes a fixing member, the support member passes through the loading body in the axial direction, the fixing member is located at the distal end of the support member and is fixedly connected to the support member, the fixing member is located in the positioning groove and abuts against the bottom wall of the positioning groove.
[0013] In one embodiment, the fastener and the support are made of the same material.
[0014] In one embodiment, the adjustment assembly includes a limiting member connected to the distal end of the support member, the limiting member being embedded in the positioning groove and fixedly connected to the first loading part; axially, the fixing member is located at the proximal end of the limiting member.
[0015] In one embodiment, the first loading part is made of the same material as the limiting member.
[0016] In one embodiment, the loading device includes a first connecting tube, one end of which is connected to the proximal end of the second loading part, and the other end is used to connect to a handle, and the support extends within the first connecting tube.
[0017] In one embodiment, the loading device includes a first connector located at the proximal end of the second loading portion and connected to the first connecting pipe and the protrusion of the second loading portion, respectively.
[0018] In one embodiment, the loading device includes a positioning member for positioning the valve prosthesis connection, wherein the first loading portion and the second loading portion are respectively movable in a direction away from the positioning member, so that the positioning member is axially located between the first loading portion and the second loading portion.
[0019] In one embodiment, the loading device includes a sleeve connected to the distal end of the positioning member, and the support extends axially through the positioning member and the sleeve.
[0020] In one embodiment, the outer surface of the support member is provided with a heat-shrinkable film.
[0021] In one embodiment, the loading device includes a second connecting tube, one end of which is connected to the proximal end of the positioning member, and the other end is used to connect to a handle.
[0022] In one embodiment, the support extends inside the second connecting tube and has a gap with the second connecting tube. A first gap is provided between the support and the proximal end of the positioning member, and the first gap communicates with the gap. The positioning member is provided with an exhaust hole, and the exhaust hole communicates with the first gap.
[0023] In one embodiment, the first connecting tube is sleeved on the outer periphery of the second connecting tube, a second gap is provided between the second connecting tube and the first connecting tube, and the positioning member has a notch in the circumferential direction, the notch communicating with the second gap.
[0024] In one embodiment, the loading device includes a guide head connected to the first loading part; the first loading part includes a protruding connecting post with the positioning groove; the guide head has a connecting groove at one end facing the connecting post, the connecting post is fixedly connected to the peripheral wall of the connecting groove, one end of the limiting member is embedded in the positioning groove, and the other end is tightly fitted to the connecting groove.
[0025] Thirdly, this application provides a valve prosthesis delivery system, including the loading device provided in the second aspect; and a handle connected to the loading device.
[0026] The technical solution of this application has the following effects:
[0027] The loading device includes two loading sections that can move relative to each other or move away from each other. The loading device is used to hold the valve prosthesis. When the two loading sections move away from each other, the valve prosthesis can be released from the loading device. After the valve prosthesis is released, one loading section can be inserted into the other loading section, thereby shortening the axial length of the loading device, facilitating the retraction of the loading device, and also facilitating the bending of the loading device, improving the convenience of operation for medical staff; when retracting the delivery system during cross-valve operations, it reduces the risk of scraping the implanted valve prosthesis.
[0028] In addition, one of the loading sections can be inserted into the cavity of the other loading section, so that the radial dimensions of the two loading sections are different, thereby facilitating the loading device to accommodate valve prostheses of different sizes. Attached Figure Description
[0029] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.
[0030] Figure 1This is an exploded structural diagram of the loading device provided in the embodiments of this application;
[0031] Figure 2 Exploded structural diagrams of the loading device provided in the embodiments of this application from different perspectives;
[0032] Figure 3 An exploded structural diagram of the loading device provided in an embodiment of this application from another perspective;
[0033] Figure 4 Another exploded structural schematic diagram of the loading device provided in the embodiments of this application;
[0034] Figure 5 This is a cross-sectional structural schematic diagram of the loading device provided in the embodiments of this application;
[0035] Figure 6 for Figure 5 A magnified structural diagram of part A in the diagram;
[0036] Figure 7 for Figure 5 A magnified structural diagram of part B in the diagram;
[0037] Figure 8 This is a cross-sectional view of the loading device containing the valve prosthesis provided in the embodiments of this application;
[0038] Figure 9 A schematic diagram illustrating the positional relationship between the valve prosthesis and the loading device during release, provided in an embodiment of this application.
[0039] Figure 10 This is a schematic diagram of the connection relationship between the valve prosthesis and the positioning element provided in the embodiments of this application;
[0040] Figure 11 This is a schematic diagram of the compressed structure of the carrier provided in an embodiment of this application.
[0041] Icons: 1-Carrier; 11-First loading part; 111-Positioning groove; 112-Connecting column; 12-Second loading part; 121-Annular boss; 122-Protruding column; 2-Fixing component; 3-Supporting component; 31-Heat shrink film; 4-Limiting component; 5-First connecting pipe; 6-First connecting component; 7-Positioning component; 71-Protrusion; 72-Notch; 73-Exhaust hole; 8-Sleeve; 9-First gap; 10-Second connecting pipe; 13-Second connecting component; 14-Second gap; 15-Guide head; 16-Groove. Detailed Implementation
[0042] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.
[0043] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, the term "distal" refers to the end of the delivery system closer to the heart tissue, and "proximal" refers to the end of the delivery system closer to the operator. The terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.
[0044] like Figure 8 and 11 As shown, in a first aspect, embodiments of this application provide a carrier for accommodating a valve prosthesis. The carrier 1 is used to accommodate the valve prosthesis and has a telescopic function. When the valve prosthesis is released, the carrier 1 can shorten its axial length, thereby improving the convenience of operation for medical staff and reducing the risk of scraping the implanted valve prosthesis when withdrawing the delivery system during cross-valve operations. In addition, the carrier can also extend to accommodate valve prostheses of different axial lengths, enabling the carrier to adapt to valve prostheses of different specifications and improving adaptability.
[0045] like Figure 1 , 2 As shown in Figures 8, 9, and 11, the loading carrier 1 includes two loading sections with openings facing each other. The two loading sections can move relative to each other or move away from each other. The loading carrier 1 is used to accommodate the valve prosthesis. When the two loading sections move away from each other, the valve prosthesis can be released. After the valve prosthesis is released, one of the loading sections can move toward the other loading section to be inserted into the chamber of the other loading section. Alternatively, the two loading sections can move relative to each other, thereby shortening the axial length of the loading carrier 1, making it easier for medical staff to withdraw the loading carrier 1 and improving the convenience of operation. In addition, when performing transvalvular operations, the shortened axial length of the loading carrier 1 facilitates the withdrawal of the loading carrier 1 by medical staff. It also makes it easier for the loading carrier 1 to navigate bends.
[0046] Optionally, the loading carrier 1 may have a radial dimension of the distal loading portion that is larger than that of the proximal loading portion, so that the loading carrier 1 can accommodate valve prostheses with a larger distal radial dimension; of course, the loading carrier 1 may also have a radial dimension of the proximal loading portion that is larger than that of the distal loading portion, so that the loading carrier 1 can accommodate valve prostheses with a larger proximal radial dimension, thereby allowing the selection of a suitable loading carrier 1 for loading according to the specifications of the valve prosthesis.
[0047] Optionally, the carrier 1 can be made of stainless steel or PEEK (polyetheretherketone), making the carrier 1 a rigid component. This provides higher radial support, reduces the wall thickness of the carrier 1, and thus lowers the radial dimension of the carrier 1. It is also suitable for loading valve prostheses with barbed structures, reducing the risk of puncturing the carrier 1 or the barbs penetrating the carrier 1, which could lead to failure to release the prosthesis.
[0048] Optionally, since the two mounting carriers 1 can move relative to each other or move away from each other, the mounting carriers 1 in this embodiment of the application can load valve prostheses with different axial lengths, thereby improving the adaptability of the mounting carriers 1.
[0049] like Figure 8 As shown, in one embodiment, the two loading portions include a first loading portion 11 located at the distal end and a second loading portion 12 located at the proximal end. The radial dimension of the distal end of the second loading portion 12 does not exceed the inner diameter of the first loading portion 11, so that the distal end of the second loading portion 12 can be inserted into the inner diameter of the first loading portion 11, which facilitates the compression of the loading body 1. At the same time, the inner diameter of the first loading portion 11 is larger than the inner diameter of the second loading portion 12, so that the loading body 1 can accommodate a valve prosthesis with a larger distal radial dimension.
[0050] like Figure 1 As shown, optionally, the proximal end of the second loading part 12 is provided with an annular boss 121. The radial dimension of the annular boss 121 is adapted to the first loading part 11. When the distal end of the second loading part 12 is inserted into the cavity of the first loading part 11, the proximal end of the first loading part 11 can abut against the annular boss 121 to improve the structural stability of the loading carrier 1 under compression and facilitate the removal of the loading carrier 1.
[0051] Optionally, in some cases, the proximal radial dimension of the first loading part 11 may not exceed the inner diameter of the second loading part 12, and the inner diameter of the first loading part 11 may be smaller than the inner diameter of the second loading part 12, so that the loading carrier 1 can accommodate a valve prosthesis with a larger proximal radial dimension.
[0052] like Figure 1 and 2 As shown, in one embodiment, the first loading part 11 includes a connecting post 112 located at the distal end for connection with the adjustment assembly. By providing the connecting post 112, the adjustment assembly is connected to the connecting post 112, enabling the adjustment assembly to control the first loading part 11, so that the first loading part 11 can move away from the second loading part 12 to expose the valve prosthesis for easy release, or the adjustment assembly can control the first loading part 11 to move towards the second loading part 12 to compress the axial length of the mounting carrier 1.
[0053] Optionally, the connecting post 112 is configured to protrude distally.
[0054] like Figures 4 to 6 As shown, optionally, the connecting column 112 is provided with a positioning groove 111, and the adjusting component is located in the positioning groove 111 and is connected to the first loading part 11.
[0055] like Figure 1 As shown, in one embodiment, the second loading part 12 includes a protrusion 122 located at the proximal end for connecting with the first connector 6. The second loading part 12 includes a protrusion 122 protruding towards the proximal end, which facilitates the connection between the first connector 6 and the second loading part 12. Furthermore, it enables the first connecting pipe 5 to be connected to the second loading part 12 through the first connector 6, thereby enabling the first connecting pipe 5 to control the movement of the second loading part 12.
[0056] like Figure 9 As shown, in a second aspect, embodiments of this application provide a loading device, including the loading carrier provided in the first aspect, and further including an adjustment component. The adjustment component is connected to the first loading part 11. The adjustment component can control the first loading part 11 to move relative to the second loading part 12, so that the first loading part 11 can move away from the second loading part 12, further exposing the valve prosthesis in the loading carrier 1 for easy release; or after the valve prosthesis is released, the first loading part 11 can be controlled to move towards the second loading part 12 to shorten the axial length of the loading carrier 1.
[0057] like Figure 1 , 2 As shown in Figures 4 to 7, in one embodiment, the adjustment component includes a support member 3, which is connected to the distal end of the first loading part 11. The support member 3 can be used to control the movement of the first loading part 11 relative to the second loading part 12, thereby improving the ease of operation.
[0058] Optionally, the support member 3 needs to have a supporting force, that is, a force that can push the first loading part 11 to move axially relative to the second loading part 12. In addition, it also needs to have bending flexibility and shape memory. The support member 3 can be a nickel-titanium tube, nickel-titanium rod, PEEK tube or braided tube, etc.
[0059] like Figures 4 to 6As shown, in one embodiment, the distal end of the first loading part 11 is provided with a positioning groove 111. The adjustment assembly also includes a fixing member 2. The support member 3 extends within the loading carrier 1 and penetrates the loading carrier 1 axially. The fixing member 2 is located at the distal end of the support member 3 and is fixedly connected to the support member 3. The fixing member 2 is located in the positioning groove 111 and abuts against the bottom wall of the positioning groove 111. The diameter of the support member 3 is relatively small, so the contact area with the first loading part 11 is small. By setting the fixing member 2 and fixing the fixing member 2 to the support member 3, the contact area between the support member 3 and the first loading part 11 is indirectly increased. Moreover, the fixing member 2 is located in the positioning groove 111, realizing the connection between the support member 3 and the first loading part 11, which facilitates the support member 3 to control the movement of the first loading part 11.
[0060] Optionally, the fastener 2 can be interference-fitted with the positioning groove 111 to improve the stability between the fastener 2 and the positioning groove 111.
[0061] Optionally, the positioning groove 111 is configured to protrude toward the far end of the mounting carrier 1.
[0062] In one implementation, the fastener 2 and the support 3 are made of the same material, which facilitates welding or gluing the fastener 2 and the support 3.
[0063] Optionally, the fixing member 2 can be made of nickel-titanium alloy, and the support member 3 can be made of nickel-titanium wire or nickel-iron rod. By utilizing the shape memory function of nickel-titanium alloy, the fixing member 2 and the support member 3 can be fixedly connected by welding and located in the positioning groove 111. The fixing member 2 increases the contact area with the first loading part 11, and the positioning groove 111 limits the fixing member 2, making it easier for the support member 3 to control the first loading part 11.
[0064] Of course, when the support 3 is made of non-metallic material, the fastener 2 is made of the same material as the support 3, and the connection can be achieved by adhesive bonding.
[0065] When the support 3 is a nickel-titanium tube or nickel-titanium rod, the fixing part 2 can also be a nickel-titanium ring. The fixing part 2 can be sleeved on the outer periphery of the support 3 for easy welding. When the support 3 is a non-metallic PEEK tube or braided tube, the fixing part 2 will be selected with the same material as the support 3. In addition, when the support 3 is a PEEK tube or braided tube, the connection between the fixing part 2 and the support 3 can be by adhesive bonding.
[0066] Of course, the fastener 2 can also be a solid part, that is, one end of the fastener 2 is connected to the end of the support 3 by welding, or it can be connected by adhesive.
[0067] like Figure 1 , 2As shown in Figures 4 to 6 and 8, in one embodiment, the adjustment assembly further includes a limiting member 4 connected to the distal end of the support member 3. The limiting member 4 is embedded in the positioning groove 111 and is fixedly connected to the first loading part 11. In the axial direction, the fixing member 2 is located at the proximal end of the limiting member 4. The limiting member 4 acts as a stop, thereby reducing the problem of the support member 3 and the fixing member 2 coming out of the positioning groove 111.
[0068] Optionally, the connection between the limiting member 4 and the far end of the support member 3 may include adhesive bonding or abutment.
[0069] Optionally, the limiting member 4 can also be interference-fitted with the positioning groove 111 to realize the connection between the limiting member 4 and the first loading part 11; of course, the limiting member 4 can also be welded to the first loading part 11.
[0070] In one embodiment, the first loading part 11 and the limiting member 4 are made of the same material. The limiting member 4 can be made of the same material as the first loading part 11, such as stainless steel, which facilitates welding. Alternatively, they can both be made of PEEK material, which facilitates gluing.
[0071] When the limiting member 4 is made of stainless steel, the fixing member 2 can be made of nickel-titanium or PEEK material. Since the materials of the fixing member 2 are different, they cannot be directly welded. When the fixing member 2 adopts a ring structure, the fixing member 2 is fixed at the far end of the support member 3, so that the far ends of the support member 3 and the fixing member 2 are on the same plane. When the limiting member 4 is embedded in the positioning groove 111 and welded to the first loading part 11, the limiting member 4 can abut against the support member 3 and the fixing member 2, increasing the contact area. The limiting member 4 can limit and stop the support member 3 and the fixing member 2 in the axial direction. In addition, when the limiting member 4 and the first loading part 11 are both made of PEEK material, the limiting member 4 can be glued to the peripheral wall of the positioning groove 111. The support member 3 can also be made of PEEK material, and the structural stability between the support member 3 and the limiting member 4 can also be further improved by gluing. At the same time, the fixing member 2 can also be glued to the limiting member 4.
[0072] Optionally, a portion of the limiting member 4 is located in the positioning groove 111 and abuts against the fixing member 2 and the support member 3, thereby limiting the axial direction of the fixing member 2 and the support member 3. The other portion is located outside the positioning groove 111 and has a radial dimension larger than the positioning groove 111, abutting against one end of the positioning groove 111.
[0073] like Figure 1 , 2As shown in Figures 5 and 9, in one embodiment, the loading device includes a first connecting tube 5. One end of the first connecting tube 5 is connected to the proximal end of the second loading part 12, and the other end is used to connect to a handle. A support member 3 extends within the first connecting tube 5. By providing the first connecting tube 5 and the support member 3 extending within the first connecting tube 5, medical personnel can easily control the second loading part 12 to move toward or away from the first loading part 11. This allows the first loading part 11 and the second loading part 12 to move relative to each other or away from each other, facilitating the compression of the axial length of the loading carrier 1 and the release of the valve prosthesis. In addition, the first loading part 11 and the second loading part 12 can move relative to each other simultaneously, shortening the compression time of the loading carrier 1, or they can move away from each other simultaneously, shortening the release time of the valve prosthesis, thereby further shortening the operation time.
[0074] like Figure 1 , 2 As shown in Figure 7, in one embodiment, the loading device includes a first connector 6, which is located near the end of the second loading part 12 and is connected to the first connecting pipe 5 and the protrusion 122 of the second loading part 12, respectively, to facilitate the connection between the first connecting pipe 5 and the second loading part 12.
[0075] Optionally, the first connector 6 can be made of the same material as the carrier 1, such as stainless steel. In this case, one end of the first connector 6 is welded to the protrusion 122, and the other end is connected to the first connecting pipe 5 by heat fusion. Alternatively, the first connector 6 and the second loading part 12 can both be made of PEEK material, in which case they can be connected to the protrusion 122 by adhesive. The other end can also be connected to the first connecting pipe 5 by heat fusion or adhesive.
[0076] Optionally, the first connector 6 is provided with a heat-fusion hole for connecting with the first connecting pipe 5, thereby increasing the contact area between the first connector 6 and the first connecting pipe 5, improving stability, and further enabling the first connecting pipe 5 to control the second loading part 12.
[0077] like Figure 1 , 2 As shown in Figures 8, 9, and 11, in one embodiment, the loading device further includes a positioning member 7 for positioning the valve prosthesis connection. The first loading part 11 and the second loading part 12 can move away from the positioning member 7 respectively, so that the positioning member 7 is located axially between the first loading part 11 and the second loading part 12, thereby realizing the detachment of the valve prosthesis from the loading carrier 1 and facilitating the release of the valve prosthesis.
[0078] like Figure 8 and 10As shown, optionally, the positioning member 7 is provided with a protrusion 71 in the circumferential direction for connecting with the lug of the valve prosthesis. By providing the protrusion 71, it is easier to connect with the valve prosthesis, so as to improve the stability between the valve prosthesis and the positioning member 7.
[0079] Optionally, the number of protrusions 71 can be set to two or three.
[0080] like Figure 3 and 5 As shown, in one embodiment, the loading device includes a sleeve 8 connected to the distal end of the positioning member 7. The support member 3 passes through the positioning member 7 and the sleeve 8 in the axial direction. By setting the sleeve 8, the sleeve 8 provides stable support for the support member 3, thereby improving the stability of the support member 3. At the same time, it also improves the concentricity between the support member 3 and the loading carrier 1, reducing the problem of the support member 3 deviating from the axis.
[0081] Optionally, the sleeve 8 can be made of metal, such as stainless steel, or other rigid plastic components.
[0082] like Figure 5 and 6 As shown, in one embodiment, the outer surface of the support member 3 is provided with a heat-shrinkable film 31, which can reduce the gap between the support member 3 and the sleeve 8, improve the concentricity between the support member 3 and the sleeve 8, and make the support member 3 and the sleeve 8 coaxial.
[0083] like Figure 1 and 2 As shown, in one embodiment, the loading device includes a second connecting tube 10. One end of the second connecting tube 10 is connected to the proximal end of the positioning member 7, and the other end is used to connect to the handle, so that the second connecting tube 10 can control the positioning member 7 to move within the loading carrier 1, which facilitates the release of the valve prosthesis and improves the convenience of operation.
[0084] like Figure 5 and 7 As shown, optionally, the loading device also includes a second connector 13, which is located near the end of the positioning member 7 and is connected to the second connecting pipe 10 and the positioning member 7 respectively, so as to facilitate the connection between the second connecting pipe 10 and the positioning member 7.
[0085] Optionally, the second connector 13 can be made of the same material as the positioning member 7, such as stainless steel. In this case, one end of the second connector 13 is welded to the positioning member 7, and the other end is connected to the second connecting pipe 10 by heat fusion. Alternatively, the second connector 13 and the positioning member 7 can also be made of PEEK material, in which case they can be connected to the positioning member 7 by adhesive. The other end can also be connected to the second connecting pipe 10 by heat fusion or adhesive.
[0086] Optionally, the second connector 13 is provided with a heat-fusion hole for connecting with the second connecting pipe 10, thereby increasing the contact area between the second connector 13 and the second connecting pipe 10, improving stability, and further enabling the second connecting pipe 10 to control the movement of the positioning member 7.
[0087] Optionally, the first connecting tube 5 and the second connecting tube 10 have a certain degree of flexibility, providing an effective working length for the delivery system to ensure that the valve prosthesis can be positioned in the designated area. The material can be a polymer tubing or a composite tubing composed of a polymer and a metal cutting tube. The polymer material can be nylon elastomer (also known as polyether block amide), nylon, polytetrafluoroethylene, etc., and the metal material can be 304 stainless steel (SUS304), nickel-titanium alloy, etc. The main processing methods are extrusion or thermoforming.
[0088] like Figure 5 , 7 As shown in Figure 11, in one embodiment, a first gap 9 is provided between the proximal ends of the support member 3 and the positioning member 7. The support member 3 extends within the second connecting tube 10, and the positioning member 7 is provided with an exhaust hole 73, which communicates with the first gap 9. The diameters of the support member 3 and the second connecting tube 10 are different, thus creating a gap between them. This facilitates the relatively independent movement of the support member 3 and the second connecting tube 10, reducing friction between them. By providing the first gap 9 between the proximal ends of the support member 3 and the positioning member 7, the first gap 9 can communicate with the gap between the support member 3 and the second connecting tube 10. During the operation, air can be vented by injecting liquid between the support member 3 and the second connecting tube 10. The air between the support member 3 and the second connecting tube 10 is discharged through the first gap 9 and the exhaust hole 73 on the positioning member 7, reducing the impact of air on the operation and improving the success rate of the operation.
[0089] Optionally, multiple exhaust ports 73 can be provided to improve exhaust efficiency.
[0090] Optionally, the locating member 7 has a groove along the axial direction at its proximal end, the groove is connected to the exhaust hole 73, and the radial dimension of the groove is larger than the diameter of the support member 3, so that a first gap 9 is formed between the locating member 7 and the support member 3.
[0091] Optionally, the positioning component 7 includes a circular base and a support portion integrally formed with the circular base. The circular base is provided with a plurality of protrusions 71 and notches 72 in the circumferential direction. The support portion is provided with an exhaust hole 73 and a groove is provided along the axial direction of the circular base. The groove communicates with the exhaust hole 73.
[0092] like Figure 5 and 7As shown, in one embodiment, the first connecting tube 5 is sleeved on the outer periphery of the second connecting tube 10, and a second gap 14 is provided between the second connecting tube 10 and the first connecting tube 5. The positioning member 7 has a notch 72 in the circumferential direction, and the notch 72 communicates with the second gap 14. The diameters of the first connecting tube 5 and the second connecting tube 10 are different, so there is a second gap 14 between the first connecting tube 5 and the second connecting tube 10. By providing a notch 72 in the circumferential direction of the positioning member 7, the second gap 14 communicates with the notch 72. During the operation, air can be vented by injecting liquid between the first connecting tube 5 and the second connecting tube 10. The air in the second gap 14 is discharged through the notch 72, reducing the impact of air on the operation and improving the success rate of the operation.
[0093] Optionally, multiple notches 72 can be provided, and the multiple notches 72 are arranged circumferentially along the positioning member 7.
[0094] like Figures 1 to 3 As shown, in one embodiment, the loading device includes a guide head 15, which is connected to the first loading part 11. By providing the guide head 15 with a conical structure and a streamlined shape at its tip, the risk of scratching the inner wall of the blood vessel can be reduced, and the entire delivery device can be guided along the blood vessel.
[0095] Optionally, the guide head 15 is provided with a groove 16 for imaging. By providing the groove 16 on the guide head 15, imaging is facilitated, and the rotation angle of the valve prosthesis can be determined, making it easier for medical staff to position the valve prosthesis.
[0096] like Figure 2 , 4 As shown in Figure 6, in one embodiment, the first loading part 11 includes a protruding connecting post 112, the connecting post 112 is provided with a positioning groove 111; the guide head 15 is provided with a connecting groove at one end facing the connecting post 112, the connecting post 112 is fixedly connected to the peripheral wall of the connecting groove, and one end of the limiting member 4 is embedded in the positioning groove 111, while the other end is tightly connected to the connecting groove, thereby realizing the connection between the guide head 15 and the first loading part 11 and improving the stability of the guide head 15 and the limiting member 4.
[0097] Optionally, the guide head 15 and the first loading part 11 can be connected by threads for easy installation; or they can be glued together.
[0098] Optionally, the limiting member 4 can be interference-fitted with the connecting groove to further improve the stability between the guide head 15 and the limiting member 4.
[0099] Thirdly, embodiments of this application provide a valve prosthesis delivery system, including the loading device provided in the second aspect; it also includes a handle connected to the loading device, the handle being able to control the loading device, thereby realizing the release of the valve prosthesis and the axial shortening of the loading carrier 1 after the valve prosthesis is released.
[0100] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.
[0101] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.
[0102] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.
Claims
1. A carrier for accommodating a valve prosthesis, characterized in that, include: Two loading sections are movable away from each other to release the valve prosthesis, and one of the loading sections can be inserted into the chamber of the other loading section after the valve prosthesis is released to shorten the axial length of the loading body relative to its loading of the valve prosthesis; The two loading sections include a first loading section located at the distal end and a second loading section located at the proximal end. The proximal end of the second loading part is provided with an annular boss, the radial dimension of which is adapted to the first loading part. When the distal end of the second loading part is inserted into the cavity of the first loading part, the proximal end of the first loading part can abut against the annular boss.
2. The carrier according to claim 1, characterized in that, The radial dimension of the distal end of the second loading part does not exceed the inner diameter of the first loading part.
3. The carrier according to claim 2, characterized in that, The first loading section includes a connecting post located at the distal end for connection with the adjustment assembly.
4. The carrier according to claim 2 or 3, characterized in that, The second loading section includes a protrusion located at the proximal end for connection with the first connector.
5. A loading device, characterized in that, Includes the carrier as described in any one of claims 2 to 4; An adjustment component is connected to a first loading section, and the adjustment component can control the movement of the first loading section relative to a second loading section; The adjustment assembly includes a support member connected to the distal end of the first loading part, and the support member can be used to control the movement of the first loading part relative to the second loading part; The first loading part has a positioning groove at its distal end. The adjustment component includes a fixing member. The support member passes through the loading body in the axial direction. The fixing member is located at the distal end of the support member and is fixedly connected to the support member. The fixing member is located in the positioning groove and abuts against the bottom wall of the positioning groove. The fixing member and the supporting member are made of the same material.
6. The loading device according to claim 5, characterized in that, The adjustment assembly includes a limiting member connected to the distal end of the support member, the limiting member being embedded in the positioning groove and fixedly connected to the first loading part; in the axial direction, the fixing member is located at the proximal end of the limiting member.
7. The loading device according to claim 6, characterized in that, The first loading part is made of the same material as the limiting member.
8. The loading device according to any one of claims 5 to 7, characterized in that, The loading device includes a first connecting tube, one end of which is connected to the proximal end of the second loading part, and the other end is used to connect to a handle, and the support extends within the first connecting tube.
9. The loading device according to claim 8, characterized in that, The loading device includes a first connector located near the end of the second loading part and connected to the first connecting pipe and the protrusion of the second loading part, respectively.
10. The loading device according to claim 8, characterized in that, The loading device includes a positioning element for positioning the valve prosthesis connection, and the first loading portion and the second loading portion are respectively movable in a direction away from the positioning element, so that the positioning element is axially located between the first loading portion and the second loading portion.
11. The loading device according to claim 10, characterized in that, The loading device includes a sleeve connected to the distal end of the positioning member, and the support extends axially through the positioning member and the sleeve.
12. The loading device according to any one of claims 5 to 7, characterized in that, The outer surface of the support is provided with a heat-shrink film.
13. The loading device according to claim 10 or 11, characterized in that, The loading device includes a second connecting tube, one end of which is connected to the proximal end of the positioning member, and the other end is used to connect to the handle.
14. The loading device according to claim 13, characterized in that, The support extends inside the second connecting tube and has a gap with the second connecting tube. A first gap is provided between the support and the proximal end of the positioning member. The first gap is connected to the gap. The positioning member is provided with an exhaust hole, which is connected to the first gap.
15. The loading device according to claim 13, characterized in that, The first connecting tube is sleeved on the outer periphery of the second connecting tube, and a second gap is provided between the second connecting tube and the first connecting tube. The positioning member has a notch in the circumferential direction, and the notch communicates with the second gap.
16. The loading device according to claim 6 or 7, characterized in that, The loading device includes a guide head, which is connected to the first loading part; The first loading part includes a protruding connecting post, and the connecting post is provided with the positioning groove; The guide head has a connecting groove at one end facing the connecting post. The connecting post is fixedly connected to the peripheral wall of the connecting groove. One end of the limiting member is embedded in the positioning groove, and the other end is tightly fitted to the connecting groove.
17. A valve prosthesis delivery system, characterized in that, Includes the loading device as described in any one of claims 5 to 16; A handle, which is connected to the loading device.
Citation Information
Patent Citations
Catheter delivery system for introducing an expandable heart valve prosthesis and medical device for the treatment of a heart valve defect
CN104470471A
