Patent Application
20240130856
This disclosure relates to the field of medical device, and in particular to a preloading and delivering system, a preloading and delivering assembly and a loading method for an interventional instrument.
With the development of medical technology, heart valve prostheses have been used to treat heart valve dysfunction. Native heart valves such as the aortic, pulmonary and mitral valves provide important functions in ensuring an adequate blood supply to the cardiovascular system. In some treatment cases, the native heart valves may deteriorate due to congenital, inflammatory or infectious reasons. This damage to the native heart valves may cause serious harm or even death.
In the related art, a common treatment method for native heart valve disease is to repair or replace the valve through surgery. In order to overcome the many complications easily caused by surgery, in related technologies, especially in transvascular technologies, flexible catheters are used for intervention and to implant the heart valve prosthesis. Transvascular techniques have less invasive procedures than surgical procedures such as open-heart surgery. In the transvascular techniques, the prosthetic valve in a loaded state is mounted on a distal portion of a flexible catheter and advanced through the patient's blood vessels until the prosthetic valve reaches the implantation site. The prosthetic valve at the end of the catheter expands to its functional size at the site of the diseased native valve.
During the implantation of a self-expandable prosthetic valve, when the operator begins to withdraw the delivery sheath to release the prosthetic valve, the prosthetic valve tends to “jump” out of the end of the sheath very quickly. In other words, the outward bias force of the stent of the prosthetic valve tends to cause the prosthetic valve to spring out of the distal end of the delivery sheath very quickly, making it difficult to deliver the prosthetic valve from the sheath in a precise and controlled manner and increasing the risk of trauma to the patient.
Secondly, in the existing valve products, usually before the valve is expanded to ⅔ of its length, the sheath is advanced to compress the valve stent and recover the valve; when the valve is fully expanded, because the end of the valve stent has been fully expanded, it is very difficult to recover the valve stent.
In order to solve the above technical problems, the present disclosure discloses an interventional instrument preloading and delivering system, including:
Optionally, the catheter component includes:
Optionally, a lock seat is fixed at the distal end of the inner sheath, and the locking portion is provided on the lock seat.
The extension section of the inner core is provided with a mounting seat, and a plurality of lock members are provided which are rod-shaped, each of which is connected to the mounting seat, and the lock members extend further proximally from the mounting seat.
The lock seat or the mounting seat is further provided with a guide hole, and the pulling wire extends outward from the guide hole.
Optionally, the locking portion is a locking hole or a locking groove.
Optionally, the catheter component further includes a wire control tube, the wire control tube is slidably fitted in the threading passage, and a proximal end of the pulling wire is fixedly connected to a distal end of the wire control tube and is controlled by the control handle through the wire control tube.
Optionally, relative to a distal port of the threading passage, when the lock member is in the locked position, the pulling wire has relative tightened and extended states.
When the pulling wire is in the tightened state, a joint between the interventional instrument and the pulling wire is close to the lock seat.
When the pulling wire is in the extended state, the interventional instrument is in the expanded state and located in the crimping device, and the joint between the interventional instrument and the pulling wire is relatively far away from the lock seat.
Optionally, the proximal end of the pulling wire and the distal end of the wire control tube is connected by the following arrangement:
Optionally, the lock member is surrounded by a slidable push block, a compression spring is arranged between the push block and the mounting seat, and an engagement portion between the lock member and the pulling wire is located at a proximal side of the push block.
Optionally, the push block is in a sheet shape and is provided with through holes for the lock members to pass through.
Optionally, a support sleeve is movably provided on the inner core, when the lock member is in the locked position, the support sleeve is in contact between the push block and the lock seat, (the compression spring deforms) and the lock member extends out of the push block to engage with the locking portion.
Optionally, a plurality of groups of pulling wires are provided, each group corresponds to a lock member and consists of a single pulling wire extending in one direction and having a wire loop at an end for movably surrounding the lock member.
Alternatively, each group consists of a single wire extending back and forth, with a wire loop formed at a turning point for movably surrounding the lock member.
Optionally, the lock seat includes a guide plate, a connecting sleeve and a fixed plate connected in sequence from a distal end to a proximal end, wherein the locking hole is opened in the fixed plate, the guide plate is provided with a guide hole corresponding to the locking hole.
The lock member passes through the guide hole in the locked position, and is inserted into the corresponding locking hole after passing over/across a periphery of the connecting sleeve, wherein a section of the lock member corresponding to the periphery of the connecting sleeve serves as a working section, and the pulling wire is constrained to the working section.
Optionally, the crimping device has a cylindrical structure with an axis direction, in the axis direction, the cylindrical structure includes:
Optionally, the distal end of the outer sheath has a diameter-enlarged section for accommodating the interventional instrument, and the locking mechanism acts on the diameter-enlarged section.
The locking mechanism acts on the proximal end of the diameter-enlarged section.
Optionally, the locking mechanism includes:
Optionally, the locking mechanism includes:
Optionally, in the axis direction, the chamber has a length greater than or equal to that of the interventional instrument in the expanded state.
Optionally, the transition section and the extension section are formed in separate pieces, and a junction of the two is located at a position of the chamber adjacent to the connection section.
Optionally, the action portion of the locking mechanism in the crimping device on the catheter component is located on the proximal side of the interventional instrument.
Optionally, the outer sheath, inner sheath, wire control tube and inner core respectively extend to the control handle.
The proximal end of the inner sheath is fixedly connected to the control handle.
The proximal ends of the outer sheath, the wire control tube and the inner core are movably connected to the control handle and are axially slidable relative to the control handle, and three driving mechanisms are provided in the control handle that are respectively in transmission fit with the outer sheath, the wire control tube and the inner core.
Optionally, the interventional instrument is a heart valve prosthesis and includes a stent and leaflets, the stent generally has a meshed cylindrical structure with a blood flow channel therein, and the leaflets cooperate with each other in the blood flow channel to open or close the blood flow channel; each leaflet includes a fixed edge fixed to the stent, and a free edge for cooperating with other leaflets to control the blood flow channel.
The stent includes:
Optionally, the first end of the annular part is formed by connected ribs with peaks and valleys; each cell section includes at least 3 to 7 peaks.
The peaks are directly connected to the corresponding guide parts.
Optionally, in an outflow direction, the guide part includes a second region and a first region.
The first region is the retrieval cell for the pulling wire to pass through.
The second region includes a second cell for fixing ears of the leaflets.
Optionally, the second cell has a top end and a bottom end, the top end is connected to a bottom end of the retrieval cell, and the bottom end is connected to the peak of the corresponding cell section positioned centrally in the circumferential direction of the corresponding cell section.
Optionally, the guide parts are evenly arranged in the circumferential direction of the annular part; both the guide parts and the annular part have hollowed cell structures;
Optionally, depending on the blood flow direction controlled by the leaflets, the first end is an outflow end, and the second end is an inflow end, wherein two ends of the fixed edge are respectively located on two adjacent guide parts, and a middle portion of the fixed edge extends to the annular part.
Optionally, in the axial direction of the annular part, the interface between the guide part and the annular part is adjacent to the free edge of the leaflet.
Optionally, adjacent leaflets are connected to each other through joint portions fixed to the stent, and each joint portion is located on a corresponding guide part.
Optionally, the guide part includes four closed regions (each closed region can be understood as a cell. Different cells in this disclosure are not strictly limited to the same size and shape, but just for the overall structural characteristic description), each closed region corresponds to a cell, and the four closed regions are:
Optionally, the sparse area further extends to the end of the guide part.
Optionally, a second cell is provided in the second region, and the second cell is used to fix the ears of the leaflets.
Optionally, the cell in the third and fourth regions adjacent to the first and second regions is a third cell, and the third cell has the largest area among all cells of the guide part.
Optionally, in a circle of cells at the second end of the annular part, each cell is quadrangular, and the two sides near the second end are longer than the two sides near the first end.
Optionally, an inner side of the stent is provided with an inner covering film, and the inner covering film is located on an inflow end of the leaflets and is fixed with the fixed edges of the leaflets.
A perivalvular leakage preventing component is fixed on an outside of the inner covering film, and the perivalvular leakage preventing component consists of spaced pieces corresponding to the cells.
Optionally, the perivalvular leakage preventing component and the inner covering film are formed in one piece, and in the expanded state, the perivalvular leakage preventing component extends outward in a radial direction of the stent from the corresponding cells.
Optionally, the inner covering film is made of PET material, and the perivalvular leakage preventing component is made of porous material.
Optionally, the perivalvular leakage preventing component is located on an inflow end of the stent. In the same piece of perivalvular leakage preventing component, the highest protruding portion is closer to an inflow end of the corresponding cell.
Optionally, a distance between the highest protruding portion of the same piece of perivalvular leakage preventing component and the inflow end of the corresponding cell is S1, and a distance between the highest protruding portion of the same piece of perivalvular leakage preventing component and an outflow end of the corresponding cell is S2, where S1:S2 is 0 to 0.8. (0.3 to 0.8 is preferred.)
Optionally, the same piece of perivalvular leakage preventing component gradually becomes thicker from the outflow end toward the inflow end, and then gradually becomes thinner after reaching the highest protruding portion.
This disclosure further provides an interventional instrument preloading and delivering system, including:
This disclosure further discloses an interventional instrument preloading and delivering assembly, including:
Optionally, the accommodation area includes:
This disclosure further discloses a loading method for an interventional instrument, including:
Specific benefits will be further explained in combination with specific structures or steps in the description of embodiments.
The technical solutions according to the embodiments of the present disclosure will be described clearly and fully in combination with the drawings according to the embodiments of the present disclosure. Obviously, the described embodiments are not all embodiments of the present disclosure, but only part of the embodiments of the present disclosure. Based on the disclosed embodiments, all other embodiments obtained by those skilled in the art without creative work fall into the scope of this disclosure.
It should be noted that, when a component is “connected” with another component, it may be directly connected to another component or may be indirectly connected to another component through a further component. When a component is “provided” on another component, it may be directly provided on another component or may be provided on another component through a further component.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art. The terms in the description of the present disclosure are used to describe specific embodiments, and not to limit the present disclosure. The term “and/or” used herein includes one or more of the listed options in any combinations, or the combination of all of the listed options.
Referring to
The interventional instrument is in the expanded state before loading, which is conducive to the later deformation and release of the interventional instrument in the human body. During the loading process, through the cooperation of the crimping device and the pulling wire, the interventional instrument is guided to transform to the compressed state and stored in the catheter component 260 so as to complete the loading. Further, the pulling wire can be used to release and retrieve the interventional instrument in the human body. The interventional instrument is radially deformable and has relative compressed and expanded states. In this embodiment, a heart valve prosthesis (valve, for short) is taken as an example. The interventional instrument, without considering the stress in vivo, is fully expanded in the expanded state, which is equivalent to a pre-shaped profile after heat treatment. The process from the expanded state to the compressed state can be regarded as an intermediate state, in which the interventional instrument is at least partially compressed. The heart valve prosthesis includes a stent and leaflets. The stent generally has a meshed and cylindrical structure, with a blood flow channel therein. There are a plurality of leaflets which cooperate with each other in the blood flow channel to open or close the blood flow channel. Referring to
Through the guide part 72, especially the retrieval cell 722, the stent 70 can be controlled throughout the whole process. Further, the arrangement and shape of the guide part 72 can reduce the impact of the self-expanding characteristic of the stent 70 on its retrieval, improving the operating experience of the medical staff and the therapeutic effect. With respect to the proportion of the guide part 72, referring to the embodiment shown in
With respect to the connection of the guide part 72, referring to the embodiment shown in
With respect to the extension trend of the guide part 72, referring to the embodiments shown in
As can be easily understood from the above, a gap is defined between the ends 721 of the guide parts 72. In one embodiment, an opening 724 is defined between two adjacent guide parts 72. In the compressed state, the two adjacent guide parts 72 contact with each other and the opening 724 is closed. During the transformation of the stent 70, the size of the opening 724 changes simultaneously.
Specifically, in one embodiment, both the guide parts 72 and the annular part 71 have hollowed cell structures. In the axial direction of the annular part 71, there are a plurality of circles of cells in the annular part 71, and the junction of the guide parts 72 and the annular part 71 is formed by the vertices of one of the circles of cells.
The cell structures of the guide part 72 and the annular part 71 can facilitate the transformation of the stent 70, and also, the mechanical properties of the stent 70 can be finely adjusted through the arrangement of the cell structures. In one embodiment, the axial length of the annular part 71 includes 1 to 2.5 cells. As shown in the figure, the axial length of the annular part 71 includes 2 cells. The specific structure of the cell may be polygonal, for example, rhombic as shown in the figure.
In one embodiment, both the guide part 72 and the annular part 71 have hollowed cell structures. The cells in the guide part 72 are divided into relative sparse areas 725 and dense areas 726. At least part of the sparse areas 725 is adjacent to the opening between two adjacent guide parts 72. Cells with different densities allow fine adjustment of the mechanical properties of different portions of the guide part 72, thereby improving the compliance of the guide part 72 and providing a smoother operating experience during the release and retrieval process.
Specifically, with reference to the embodiments shown in
The first region 7271 corresponds to the retrieval cell 722, which is used for the pulling wire 21 to pass through. The second region 7272 includes a second cell 7351, and the second cell 7351 is used to fix ears 7352 of two adjacent leaflets 73. The second cell 7351 has a top end and a bottom end, the top end is connected to the bottom end of the retrieval cell 722, and the bottom end is connected to the peak of the corresponding cell section, which peak is positioned centrally in the circumferential direction of the corresponding cell section.
Specifically, the guide part 72 includes four closed regions 727:
The third and fourth regions are symmetrically distributed on two sides of the second region, and have the same number and size of cells. Among the first, second, third, and fourth cells, the third and fourth cells have the same size with the largest area, the first cell has the smallest area, and the area of the second cell is between those of the first and third cells.
The dense area 726 of the second region 7272 can be implemented by increasing the number of cells within the same area, or by reducing the corresponding area with the same number of cells. In any case, the dense area 726 includes more ribs per unit area. In one embodiment, the cell area of the dense area 726 is 0.3 to 0.8 times the cell area of the sparse area 725. In a specific product, the cell area of the dense area 726 is 0.4 to 0.6 times the cell area of the sparse area 725.
Referring to the embodiment shown in
Referring to the embodiment shown in
In this regard, the stents 70 in
For some stents of large sizes, for example, having a length in the range of 45 to 46 mm and a maximum outer diameter in the range of 32 to 35 mm, the guide part 71 of the stent is difficult to be compressed. Therefore, the area and location of the sparse area 725 need to be further optimized. In another embodiment as shown in
This embodiment has a structure similar to that of the embodiment shown in
The embodiment shown in
The guide part 72b includes four regions, which are:
In this embodiment, among the first, second, and third cells, the third cell has the largest area, the second cell has the smallest area, and the area of the first cell is between those of the third cell and the second cell.
The annular part includes a plurality of rows of cells, and the size of the cells decreases in the direction towards the guide part.
Only one cell is provided in each region, and one vertex of each cell in the second, third, and fourth regions is connected to the annular part 71. The cells in the sparse area 725 have approximately the same area, and the cells in the dense area 726 have approximately the same area. The cell area of the dense area 726 is 0.15 to 0.5 times, for example, 0.25 times the cell area of the sparse area 725.
At the inflow end of the stent, that is, on the inflow peaks of the inflow cell section, radiopaque element(s) is provided. For example, precious metal can be locally embedded in the inflow peaks or the inflow peaks can be consisted of precious metal. The precious metal can be distinguished from other portions by X-ray or other means of detection.
The throughout control of the stent 70 is based on the retrieval cell 722. Referring to the embodiment shown in
With respect to the arrangement of the pulling section 7221, in one embodiment, the pulling section 7221 and a transition section 7222 enclose one or more closed spaces. In terms of the size of the closed space, the radius of the circumscribed circle of the retrieval cell 722 is greater than or equal to twice the diameter of the strut of the retrieval cell 722. Such arrangement means that the retrieval cell 722 individually occupies a certain space, instead of an opening defined in the strut. Furthermore, both the guide part 72 and the annular part 71 have hollowed cell structures. On the circumferential surface of the stent 70, the projection area of the closed space is greater than or equal to the projection area of a single cell structure. In case of a plurality of closed spaces, the projection area of the closed space mentioned above refers to the total area of all of the closed spaces. In this embodiment, the projection area of the closed space is at least 2 square millimeters to 25 square millimeters.
In one embodiment, within the guide part 72, the edge strut 7282 is adjacent to the opening. One end of the edge strut 7282 is connected to the retrieval cell and the connection portion is adjacent to the pulling section 7221, the other end of the edge strut 7282 is connected to the annular part 71. In the figure, the retrieval cell 722 has a transition section 7222 shared with the surrounding cells on the side close to the annular part 71. The transition section 7222 is V-shaped, with its apex facing the annular part 71.
Regarding the overall shape of the stent 70, with reference to the embodiments shown in
Within a circle of cells at the second end of the annular part 71, each cell is quadrangular, and the two sides near the second end are longer than the two sides near the first end, which is more convenient for radial compression of the end during retrieval or loading.
Specifically, as shown in
Referring to the figures, in the circumferential direction of the annular part 71, each guide part 72 has an axis of symmetry 7284 of its own structure, and the fixed edges 731 of two adjacent leaflets 73 meet at the axis of symmetry 7284 of the corresponding guide part 72. Viewed from another perspective, the midpoint of the fixed edge 731 is adjacent to the axial middle of the annular part 71.
Referring to the embodiment shown in
The stent 70 is further provided with a perivalvular leakage preventing component 741 located on the inflow end 734 of the leaflets 73. The perivalvular leakage preventing component 741 can be exposed out of the outer circumferential surface of the stent 70. Alternatively, an outer covering film can be provided to cover the perivalvular leakage preventing component 741, that is, the inner covering film 74 and the outer covering film cover the perivalvular leakage preventing component 741 in the radial direction of the cylindrical structure.
The perivalvular leakage preventing component 741 can be in the shape of a long strip and surround the outer periphery of the stent 70. Alternatively, as shown in
In another embodiment, as shown in
The one single piece can be formed by infiltration and fusion. The inner covering film is made of PET material, and the perivalvular leakage preventing component 741 is made of porous material, such as PU material. The holes can be the structural gaps of the inner covering film material or formed by additional processing. In the radial direction of the stent, the inner surface of the inner covering film is provided with a coating to ensure the sealing effect and close the gaps. As shown in
As shown in
As shown in
As for one piece of the perivalvular leakage preventing component 741, it gradually becomes thicker from the outflow end 733 toward the inflow end 734, and then gradually becomes thinner after reaching the highest protrusion (in the radial direction of the stent). The thickness variation facilitates retrieval of the highest protrusion. The highest protrusion is closer to the inflow end. It can be seen from the figure that the distance between the highest protrusion of the perivalvular leakage preventing component 741 and the inflow end of the corresponding cell is S1. The distance between the highest protrusion of the perivalvular leakage preventing component 741 and the outflow end of the corresponding cell is S2. The ratio of S1:S2 ranges from 0 to 0.8, and preferably, from 0.3 to 0.8 in a specific product. The perivalvular leakage preventing component 741 can fill the space surrounded by the struts of the corresponding cell in area. The perivalvular leakage preventing component 741 is protruded to be in close contact with the side edges of the struts of the cell. That is, the lowest position of the perivalvular leakage preventing component 741 is not lower than the outer circumferential surfaces of the struts of the cell, so as to avoid gap(s) between the perivalvular leakage preventing component 741 and the side edges of the struts, which gap(s) may reduce the deformation of the perivalvular leakage preventing component 741 and thus affect the blocking effect. The side edge of the strut refers to the side of the strut facing the interior of the corresponding cell. In some cases, the perivalvular leakage preventing component can be higher than the outer circumferential surface of the stent in the expanded state.
Referring to
The relative movement between the inner core 10 and the inner sheath 30 can cause the relative movement between the lock seat 31 and the lock member 13, thereby changing the constraint on the pulling wire 21. The pulling wire 21 can affect the movement of the interventional instrument 90, especially during the release process of the interventional instrument 90, so that the interventional instrument 90 can be released by stages through the pulling wire 21. Further, the sheathes that can move relative to each other provide structural basis for the throughout release and retrieval process of the interventional instrument 90, thereby providing a controllable interventional therapy, improving the therapy effect as well as the patient experience.
Here, the pulling wire 21 mainly cooperates with the retrieval cell 722 to control the interventional instrument. The structural compliance of the interventional instrument during the state switching process is improved by optimizing the structure of the guide part 72, thereby avoiding problems occurred in the throughout retrieval process of the exiting interventional instruments.
The interventional instrument 90 can be a heart valve prosthesis or a vascular stent, etc. The heart valve prosthesis can include a stent and valve leaflets connected to the stent to control blood flow. The number of leaflets is generally two or three. As required, skirt(s) can be added to the inside and/or outside of the stent. The stent itself can be formed by braiding or cutting a tube. A heart valve prosthesis can be used to replace a diseased valve in the heart, particularly the aortic valve, for example.
The lock member 13 is locked so that the pulling wire 21 is constrained. It can be understood that the pulling wire 21 will also function on the lock member 13 and thus affect the locking effect. In order to improve the mechanical properties of the lock member 13, according to an embodiment, the lock seat 31 is provided with a locking portion for engaging with the lock member 13. In the locked state, the lock member 13 is inserted into the locking portion to limit the movement of the pulling wire 21. The locking hole 311 can limit the lock member 13 on the side of the lock member 13 sway from the fixed side of the lock member 13, thereby improving the overall mechanical performance of the lock member 13. Structurally, as shown in the figures, the locking hole 311 can be a through hole or blind hole for the lock member 13 to pass through. Alternatively, the locking hole 311 can be formed as a positioning structure, for example, a positioning recess or positioning protrusion, that can improve the positioning effect of the lock member 13. Accordingly, the structure of the lock member 13 should also be adjusted.
The lock member 13 and the locking hole 311 are engaged with each other due to the relative movement between the inner sheath 30 and the inner core 10. In one embodiment, the lock member 13 moves with the inner core 10 and has the following positions:
Different positions of the lock member 13 correspond to different limits on the movement of the pulling wire in the threading passage 12. In the embodiment shown in figures, the lock member 13 functions to divide a separate constraint space in the threading passage 12. When the pulling wire 21 is located at a preset position (generally through assembly), the lock member 13 constrains the pulling wire 21. In the release position, the above-mentioned constraint space is communicated with the threading passage 12, so that the pulling wire 21 can move freely to release the interventional instrument 90.
It should be noted that the pulling wire 21 is not completely immobile when being locked by the lock member 13. The pulling wire 21 can achieve the following functions based on its own material (for example, a deformable material) or size (for example, with a long extension length): when the pulling wire 21 is constrained by the lock member 13, it can release a preset movement of interventional instrument 90 through its own deformation. With reference to the embodiment shown in
It should be noted that the deformation of the pulling wire 21 mentioned above refers to the deformation in the extension path of the pulling wire 21 rather than the length change caused by material stretching. In this field, in order to control the release of the valve by the pulling wire, the stretching rate of the pulling wire should be as small as possible. Other description about the deformation of the pulling wire 21 in this disclosure should also meet this requirement.
As mentioned above, one end of the lock member 13 is limited by the locking hole 311, and the other end also requires a corresponding structure for a stable connection. In one embodiment, the extension section 11 of the inner core 10 is provided with a mounting seat 131, and there are a plurality of lock members 13 that are rod-shaped and are all fixed to the mounting seat 131 and extend proximally from the mounting seat 131. The mounting seat 131 is provided with mounting holes 132 for mounting the lock members 13. The distal end of the lock member 13 is inserted and fixed in the mounting hole 132, and the proximal end of the lock member 13 extends out of the mounting hole 132. In order to facilitate limiting the threading of the pulling wire 21, guide holes 312 can be provided in the lock seat 31 or the mounting seat 131, and the pulling wire 21 extends outward from the corresponding guide hole 312.
The engagement direction of the lock member 13 with the locking hole 311 in this embodiment is also important. It can be understood that the distal end of the lock member 13 is connected to the inner core 10, and the proximal end of the lock member 13 extends toward the lock seat 31 and engages with the locking hole 311 as it moves. The lock member 13 moves proximally (from the distal end to the proximal end) to engage with the locking hole 311, which can improve the compactness of the structure. In the embodiment shown in the figures, the lock member 13 and the mounting seat 131 in the lock seat 31 can be arranged inside the interventional instrument 90 in the loaded state, which are located in the bare stent section of the valve stent and can fill the large gap between the valve stent and the inner core in the loaded state, preventing the valve stent from collapsing or bending due to lack of support during the crimping process. Further, providing the lock member 13 at the front end can effectively reduce the interference with the pulling wire tube and the pulling wire, facilitating the control of the overall volume of the delivering system and making a series of operations convenient during the interventional therapy.
More importantly, the lock member 13 arranged in such direction makes the process of assembling the interventional instrument 90 to the delivering system more convenient. On the contrary, if a locking structure moving distally (from the proximal end to the distal end) for engagement is used, the process of assembling the interventional instrument will be more cumbersome and the interventional instrument is very easy to fall off, resulting in rework and affecting production efficiency.
The mounting hole 132 allows a stable engagement between the lock member 13 and the mounting seat 131. In a specific product, the lock member 13 can be fixedly connected with the mounting hole 132. Considering the production difficulty, bonding or welding is preferred. During the assembly, the structure of the mounting hole 132 can facilitate the assembly process and improve production efficiency. On this basis, in one embodiment, the mounting hole 132 is opened on the circumferential surface of the mounting seat 131, and the opened portion can at least accommodate the lock member 13.
The opened mounting hole 132 can facilitate operation and inspection, ensure the stability of the connection, and improve the overall stability of the device. More importantly, the opened mounting hole 132 can structurally ensure that the lock member 13 is mounted to the bottom of the mounting hole 132, avoiding the uncertainty caused by a blind hole, thereby ensuring the locking spacing between the end surface of the lock member 13 and the locking hole 311.
In terms of quantity, the lock members 13 and the locking holes 311 can be adjusted as required. In one embodiment, a plurality of lock members 13 are provided at intervals in the circumferential direction of the inner core 10, and the locking holes 311 are arranged corresponding to the lock members 13. The number of lock members 13 and locking holes 311 can be adjusted to improve the constraint on the pulling wire 21, thereby achieving multi-dimensional control of the interventional instrument 90, which is particularly significant in improving control accuracy. However, the increase in quantity will increase the complexity of the structure, which will have a certain impact on assembly and stability. Therefore, in a specific product, at least three lock members 13 are evenly arranged in the circumferential direction of the inner core 10, and the locking holes 311 are arranged corresponding to the lock members 13.
Referring to
The push block 134 is in a sheet shape and is provided with through holes for the lock members 13 to pass through. The distance between the push block 134 and the mounting seat 131 is greater than or equal to the length of the compression spring 135 in its natural state, thereby preventing the push block 134 from being separated from the lock members 13 under the action of the compression spring 135.
When operating the inner core 10 to drive the lock member 13 to engage with the guide hole 312 in the lock seat 31, after the push block 134 abuts the lock seat 31, the compression spring 135 is compressed. When it is desired to release the engagement between the pulling wire 21 and the lock member 13, the compression spring 135 returns to drive the push block 134 to push the pulling wire 21 to move proximally so that the proximal section of the lock member 13 exposed out of the push block 134 is reduced, which facilitates the disengagement between the engagement loop 22 of the pulling wire 21 and the lock member 13.
A support sleeve 317 is movably installed on the inner core 10. When the lock member 13 is in the locked position, the support sleeve 317 is in contact between the push block 134 and the lock seat 13, the compression spring deforms, and the lock member 13 extends out of the push block 134 to engage with the locking portion.
It is the pulling wire 21 that actually interacts with the interventional instrument, so the arrangement details of the pulling wire 21 also have a synergistic effect. In one embodiment, the delivering system for the interventional instrument 90 further includes a wire control tube 20. The wire control tubes 20 are arranged movably around the inner core 10. One end of the pulling wire 21 is a driving end 211 that is connected to the wire control tube 20, the other end of the pulling wire is the working end 212 (i.e., the engagement loop 22 below). When the interventional instrument is in the loaded state, the working end 212 is wound around the interventional instrument 90 and then engages with the lock member 13. There are multiple groups of pulling wires 21, and each group corresponds to one lock member 13 and consists of a single pulling wire 21 that extends in one direction and has a wire loop (i.e., the engagement loop 22) at the end, and is movably connected to the lock member 13 through the wire loop.
Alternatively, each group of pulling wire 21 consists of a single pulling wire that extends back and forth, with a wire loop formed at the turning point, and is movably connected to the lock member through the wire loop.
The wire control tube 20 functions to control the working state of the pulling wire 21, and in particular, to control the interventional instrument 90 by controlling the pulling wire 21. In this embodiment, the wire control tube 20 is movably provided to realize its own driving function. Specifically, the proximal end of the wire control tube 21 is movable relative to the control handle. In this embodiment, the proximal end of the wire control tube 21 is movable relative to the inner sheath. Regarding the specific structure of the wire control tube 20, refer to one embodiment in which the wire control tube 20 is movably disposed between the inner core 10 and the inner sheath 30. The wire control tube 20 is disposed between the inner core 10 and the inner sheath 30 to avoid interference between the wire control tube 20 and the lock seat 31, thereby providing more space for the assembly of the interventional instrument 90.
The wire control tube 20 is a tube in the embodiment shown in the figures. However, it is also possible by extending the proximal end of the pulling wire 21, that is, it is possible to achieve the above function by directly operating the proximal end of the pulling wire 21 through the control handle 60. Therefore, in a specific product, the specific form of the wire control tube 20 may be varied. The description below is mainly based on the form of the wire control tube 20 as shown in the figure. The same applies to other forms and will not be repeated again.
Referring to the above description and in combination with the embodiment of
The working state of the lock member 13 and the working state of the wire control tube 20 can be linked or independent of each other. In case where the two are independent of each other, when the lock member 13 is not unlocked, the wire control tube 20 can control the constrained pulling wire 21 to adjust its state through its own movement.
Regarding the specific structure of the lock seat, refer to one embodiment in which the lock seat 31 includes a guide plate 313, a connecting sleeve 314 and a fixed plate 315 connected in sequence from the distal end to the proximal end. The locking hole 311 is opened in the fixed plate 315, and the guide hole 312 is opened in the guide plate 313 and corresponds to the locking hole 311 in position.
The lock member 13 passes through the guide hole 316 in the locked position, and is inserted into the corresponding locking hole 311 after passing over/across the periphery of the connecting sleeve 314. The section of the lock member 13 located over/across the periphery of the connecting sleeve 314 serves as the working section, and the working end 212 of the pulling wire 21 is constrained on this working section.
The guide plate 313 and the fixed plate 315 define a relatively small and closed space in the threading passage 12, which can effectively improve the stability of the lock member 13 with respect to the pulling wire 21. Also, under the action of the guide hole 316, the mechanical properties of the lock member 13 can be effectively improved, ensuring that the interventional instrument 90 with high elasticity can be controlled.
In addition to providing guidance for the lock member 13, the lock seat 31 can also provide guidance for the pulling wire 21. In the embodiment as shown in
For connection with the wire control tube 20, the pulling wire 21 needs to pass through the fixed plate 315 of the lock seat 31. That is to say, the pulling wire 21 engages with the lock member 13 through the guide hole 312. The guide hole 312 can guide the pulling wire 21, thereby achieving stable driving of the pulling wire 21 by the wire control tube 20. Furthermore, the guide hole 312, depending on its own position, can adjust the force application point of the pulling wire 21 on the interventional instrument 90, thereby better controlling the interventional instrument 90. In one embodiment, the lock seat 31 is provided with locking holes 311 that engage with the lock members 13. There are a plurality of guide holes 312 and locking holes 311, which are alternately arranged in the circumferential direction of the fixed plate 315. The adjacent guide hole 312 and locking hole 311 can not only adjust the force application point of the pulling wire 21 on the interventional instrument 90 as mentioned above, but also facilitate a compact arrangement of the various structures of the lock seat 31 while avoiding undesired interference between adjacent pulling wires 21 (if there are a plurality of pulling wires 21).
The constraint on the pulling wire 21 is actually determined by three factors, namely how the proximal end of the pulling wire 21 is related to the control handle (in this embodiment, the proximal end of the pulling wire 21 is connected to the wire control tube), how the working end 212 of the pulling wire 21 interacts with the interventional instrument 90, and how the working end 212 of the pulling wire 21 interacts with the lock member 13, which will be exemplarily explained below.
Regarding how the working end 212 of the pulling wire 21 is related to the interventional instrument 90, with reference to an embodiment, the pulling wire 21 and the interventional instrument 90 are configured as follows:
This embodiment includes the two implementation methods.
The working end 212 of the pulling wire 21 engages with the lock member 13 after passing through the structure of the interventional instrument 90 (refer to
The working end 212 of the pulling wire 21 extends in the direction of the interventional instrument 90, passes through the hole at the end of the interventional instrument 90, extends in the direction of the lock seat 31, and is finally wounded around the locking rod between the guide plate 313 and the fixed plate 315. The advantage of this embodiment is that it can realize direct control of the interventional instrument 90 by the pulling wire 21 and has a small number of components, which facilitates production and assembly while reducing the possibility of component failure.
Regarding the specific engagement between the pulling wire 21 and the lock member 13, refer to one embodiment in which one end of the pulling wire 21 that engages with the lock member 13 (i.e., the working end 212) is provided with an engagement loop 22, and the lock member 13 passes through the engagement loop 22 to constrain the pulling wire 21.
The lock member 13 in the locked position passes through the closed space enclosed by the pulling wire 21 to constrain the pulling wire 21. The closed space can be formed by the threading of the pulling wire 21 or provided by the engagement loop 22.
Regarding the formation of the engagement loop 22, according to an embodiment, the engagement loop 22 can be a separate component or is formed by winding the pulling wire 21. The separate component allows the use of different materials. For example, in some embodiments, the engagement loop 22 is made of a radiopaque material to facilitate real-time control of the intervention process. The method by winding the pulling wire 21 involves a simple and stable structure, which facilitates production and assembly.
Regarding the specific form of winding, the pulling wire 21 can be a single wire extending from the driving end 211 to the working end 212, and the single wire is wound at the working end 212 to form the engagement loop. Alternatively, the pulling wire 21 has a double-wire structure, which is folded back at the working end 212, and the folded portion forms the engagement loop.
In order to drive the pulling wire 21, the catheter component further includes a wire control tube 20. The wire control tube 20 is arranged around the outside of the inner core 10. One end of the pulling wire 21 is the driving end 211 which extends proximally in the wire control tube 20 and is controlled by the control handle, and the other end of the pulling wire 21 is the working end 212 (i.e., the engagement loop 22 below). When the interventional instrument is in the loaded state, the working end 212 engages with the lock member 13 after winding around the interventional instrument 90.
Compared with the above embodiments, the wire control tube 20 in this embodiment provides an independent movement space for the pulling wire 21, to prevent the pulling wires 21 from interfering with each other during the movement. The proximal end of the pulling wire 21 can be directly controlled by the control handle, or can be connected to the control handle through an intermediate component.
The outer sheath 50 can cover or release the interventional instrument 90 through its movement relative to the inner core 10. With the cooperation of the pulling wire 21 mentioned above, the outer sheath 50 can retrieve the interventional instrument 90, thereby realizing a controllable release process of the interventional instrument 90.
As shown in
The controlled components can be all configured as sheathes which are in insertion fit, or not sheathes, but only extend proximally to the control handle. The controlled components can move relative to the control handle, or one or more of them can be fixedly positioned relative to the control handle.
Thread transmission, rack-and-pinion transmission, and direct transmission each have their own advantages. The arrangement in sequence from the distal end to the proximal end of the control handle 60 can meet the different movement requirements of the sheathes and utilize the spatial structure of the control handle 60 for structural optimization, thereby improving the driven effect of the controlled components within a certain volume of the control handle 60, which will be explained below in conjunction with the specific structure.
The control handle 60 includes a thread fitting area 62 located on the distal side and a rack-and-pinion fitting area 63 located on the proximal side in the axial direction. The connection components by thread transmission and rack-and-pinion transmission are respectively arranged in the corresponding fitting areas.
Thread fit and rack-and-pinion fit are characterized by their ability to provide stable transmission ratios, especially when the controlled components require precise control. The advantage of the thread fit is that rotation in the circumferential direction of the control handle 60 can be achieved, which facilitates to save the circumferential space of the handle, but still requires a certain axial space. On the other hand, the advantage of the rack-and-pinion fit is that it can save the axial space of the handle, but still requires a certain circumferential space. In this embodiment, the arrangement of the control handle 60 is optimized by complementing the advantages and disadvantages of the two fit forms, while ensuring the driving effect. In a specific product, the ratio of the axial length of the thread fitting area 62 to the axial length of the control handle 60 is greater than or equal to 0.4. It is further preferred that the ratio of the axial length of the thread fitting area 62 to the axial length of the control handle 60 is greater than or equal to 0.55.
In this embodiment, the thread fitting area 62 is provided with a thread connection component 621, which includes:
The clamping member 625 has a mounting hole, and the proximal end of the outer sheath 50 is inserted into the mounting hole and is clamped and fixed by the wall of the mounting hole. Additionally, glue or fastener can be used to prevent loosening.
The outer surface of the driving ring 622 is provided with a friction surface for the operator to hold. As an active component, the driving ring 622 is rotatably installed on the support body 61 to drive the clamping member 625. The support body 61 can be provided with an axial groove and the clamping member 625 is slidably disposed in the axial groove. The clamping member 625 is at least partially provided with a male thread structure for engaging with the driving ring 622 in a transmission manner. The clamping member 625 is mainly used to fix the proximal end of the controlled component. When the controlled component is a sheath, it is preferred that the clamping member 625 is connected with the sheath in a sealing manner.
The controlled component needs to be positioned after moving to an appropriate position to avoid being affected by other operations. In one embodiment, the support body 61 is surrounded by a slidable positioning ring 623 on the outer periphery thereof, and the driving ring 622 has a positioned state in which the driving ring 622 engages with the positioning ring 623 and a free state in which the driving ring 622 is separated from the positioning ring 623. In the positioned state, the positioning ring 623 limits the rotation of the driving ring 622.
The positioning ring 623 is a structure that is slidably installed on the support body 61 and can position or release the driving ring 622 by changing its position.
It should be noted that the positioning ring 623 should prevent itself from rotating relative to the support body 61 while sliding on the support body 61. Therefore, a guide groove/slide rail can be provided on the support body 61. The positioning ring 623 and the guide groove/slide rail can be engaged with each other in an interference fit to ensure friction between the two and avoid the failure of the restriction of the positioning ring 623 on the driving ring 622 or an accidental locking affecting the operator's therapy.
Referring to
Referring to
Regarding the specific structure of the pinion connection component 631, according to an embodiment, a group of pinion connection component 631 is provided that is disposed close to the proximal end of the support body 61 and includes:
The clamping seat 633 has a mounting hole. The proximal end of the wire control tube 20 is inserted into the mounting hole and is clamped and fixed by the wall of the mounting hole. Additionally, glue or fastener can be used to prevent loosening.
In this embodiment, the pinion 635, as an active component, can drive the rack 634 to move to drive the controlled component. At least a part of the pinion 635 extends to the outside of the support body 61 or is provided with a corresponding structure extending to the outside of the support body 61, in order to facilitate operation and assembly and utilize the peripheral space of the support body to improve space utilization.
In a specific product, the rack 634 can be provided with a corresponding structure to improve cooperation with the controlled component. In one embodiment, the control handle 60 includes a support cylinder 638 that surrounds the proximal end of the support body. The controlled component and the pinion is connected based on the following arrangement provided in the support body 61:
The base 632 functions to provide stable motion constraint, the clamping seat 633 can realize the positioning of the wire control tube 20 and the application of driving force, and the rack 634 is used to bear the driving force from the pinion 635.
The clamping seat 633 can be fixedly installed on the base 632. Alternatively, the clamping seat 633 can have a slight axial movement margin relative to the base 632. For example, a guide structure (a slide rail 6321 shown in
Similar to the thread connection component 621 above, the controlled components need to be positioned after moving to an appropriate position to avoid being affected by other operations. In one embodiment, the pinion 635 is linked with a driving portion 636 that extends radially to the outside of the support cylinder. The driving portion 636 is movably installed on the support cylinder 638. Specifically, the driving portion 636 can rotate relative to the support cylinder 638 to drive the pinion 635 to rotate, and the driving portion 636 can slide relative to the support cylinder 638. Further, a connection locking mechanism 637 is provided between the two to limit the rotation of the driving portion 636.
Referring to
The pinion 635 is fixedly connected to the driving portion 636 and can slide relative to the support cylinder 638 in its axial direction so as to achieve meshing or separation of the first locking teeth 6371 and the second locking teeth 6372. It should be noted that the rotation axis of the driving portion 636 is collinear with the rotation axis of the pinion 635 and extends substantially in the radial direction of the control handle. The sliding direction of the driving portion 636, when switching positions, is consistent with the direction of the rotation axis of the driving portion 636.
The pinion 635 is always meshed with the rack 634 during the sliding process. That is, the pinion 635 is always meshed with the rack 634 during its own sliding stroke, which can be achieved, for example, by providing the rack 634 with a meshing width larger than that of the pinion 635.
According to an embodiment, the maintaining component 6373 functions to maintain the relative position of the driving portion 636 and the outer protrusion 6382, thereby maintaining the locking effect. Specifically, the maintaining component 6373 includes:
When the two snapping posts 6374 are far away from each other, the end surface of the snapping post 6374 abuts one of the end surfaces of the snapping block 6381 to keep the connection locking mechanism 637 in a locked or unlocked state. When the two snapping posts 6374 are close to each other, the snapping post 6374 can overcome the constraint of the snapping block 6381 to realize the state switching of the connection locking mechanism 637.
The maintaining component 6373 actually functions as a secondary lock member to ensure the stability of the connection locking mechanism 637.
According to an embodiment, the pinion 635 has a rotation shaft 6351 connected to the driving portion 636. The support cylinder 638 is fixedly provided with a limiting seat 6383 that surrounds the outside of the rotation shaft 6351. The limiting seat 6383 can abut the end surface of the pinion 635 to prevent the driving portion 636 and the pinion 635 from being separated from the support cylinder 638.
According to an embodiment, the support body 61 is fixedly installed with a first fixed seat 611 fixedly connected to the inner sheath 30. The first fixed seat 611 is located between the clamping member 625 and the clamping seat 633 in the axial direction of the support body. The proximal end of the support body 61 is slidably mounted with a sliding seat 612 fixedly connected to the inner core 10.
The control handle 60 is provided with an exhaust component 64 as a fixed connection component, and the corresponding controlled component is proximally communicated with and fixed to the exhaust component. The proximal end of the protection sheath 51 is fixedly connected to the exhaust component 64.
The air in the radial gap between the protection sheath 51 and the outer sheath 50 can be evacuated to the distal end by injecting liquid (for example, physiological saline) through the liquid injection hole 641 in the exhaust component 64.
It is possible to realize the emptying of the sheathes by the single exhaust component by opening holes in the walls of the sheathes in combination with relative movement. The sheathes sharing a single exhaust component 64 can effectively avoid repeat of exhaust components 64 and improve the utilization of the component in the control handle 60.
Referring to
A radially deformable locking mechanism is disposed at one end of the connection section 241, which has a locked state in which the crimping device 240 and the outer sheath 50 are fixed relative to each other, and an unlocked state in which the crimping device 240 and the outer sheath 50 can be separated from each other. During the locking process, the outer sheath 50 deforms at the corresponding position (the position where the locking mechanism locks).
In this embodiment, the length of the connection section 241 is 30 to 80 mm (larger than the length of a common valve). For example, after the valve is retracted into the outer sheath 50, the length between the proximal end of the valve and the distal end of the outer sheath 50 is L3. The distance between the force application portion of the locking mechanism and the distal end of the outer sheath 50 is L4. L4 is greater than L3. The deformation (radial shrinkage) of the outer sheath 50, especially the valve-accommodation area, can be avoided and the resistance of loading the valve can be reduced.
The transition section 242 is enlarged relative to the connection section 241 and has an inner conical surface 2421 that guides the radial deformation of the valve. The transition section 242 is fixed to an end of the connection section 241 away from the locking mechanism. The valve in the expanded state can be compressed under the guidance of the inner conical surface 2421, and then loaded into the outer sheath 50 through the connection section 241. Alternatively, the stent can be partially deformed. That is, in the pre-loaded state, a part of the stent can be radially compressed by the inner conical surface 2421, or has been in the compressed state.
One end of the extension section 243 and the transition section 242 form a chamber 2431 for receiving the valve in the expanded state. The distal end of the extension section 243 has an opening 2432 for pre-loading the valve and fluid immersion among others. The crimping device 240 is made of transparent material, which facilitates observation of the valve status and the position relationship relative to the outer sheath.
The chamber 2431 has sufficient axial length, which is generally larger than the valve length, so that the valve can be fully received in the chamber even in the expanded state, avoiding long-time crimping of the valve material of the valve, which cooperates with the wire control method, so that the valve can still assume the expanded state through the release of the pulling wire even after the valve is connected with the pulling wire.
The specific arrangement of the locking mechanism can be varied. Two options are provided below. Refer to
The sliding sleeve 244 in the fastening position gathers and exerts force on the plurality of elastic claws 2411 inward, causing the elastic claws 2411 to deform radially inward (which can be understood as the radial deformation of the locking mechanism) to press the outer sheath 50;
The distal end of the outer sheath 50 has a diameter-enlarged section for accommodating the interventional instrument, and the locking mechanism acts on the diameter-enlarged section.
The sliding sleeve 244 in the release position releases the force exerted on the plurality of elastic claws 2411. The sliding sleeve 244 is more convenient to operate.
Referring to
In the figure, the elastic claws 2411 correspond to a first protruding ring 2413a and a second protruding ring 2413b in the axial direction, and the first protruding ring 2413a is higher than the second protruding ring 2413b. The sliding sleeve 244 has a cylindrical structure with a constant outer diameter and a first region 2442 and a second region 2443 adapted to the first protruding ring 2413a and the second protruding ring 2413b in the axial direction. The inner diameter of the first region 2442 is greater than the second region 2443.
When the sliding sleeve 244 switches from the release position to the fastening position, the second region 2443 abuts the first protruding ring 2413a and is restricted from further sliding. A groove 2414 is formed between the two protruding rings, and a protrusion 2441 matching the groove 2414 is provided between the two regions. In the fastening position, the protrusion 2441 is received in the groove 2414 to prevent the sliding sleeve 244 from sliding proximally to switch to the release position, which avoids accidental unlocking of the crimping device during loading, and also providing locking and limiting effect.
The inner wall of the sliding sleeve 244 is provided with a plurality of friction-reducing ribs 2444, the friction-reducing ribs 2444 extend in the axial direction, and the friction-reducing ribs 2444 are distributed in the circumferential direction of the connection section 241. The friction-reducing ribs 2444 constitute the second region 2443, and the protrusion 2441 is provided at the proximal end of the friction-reducing ribs 2444.
To facilitate operation, the outer wall of the sliding sleeve 244 can be provided with an anti-slip structure. For example, there are multiple anti-slip ribs 2445 extending in the circumferential direction of the connection section 241 and spaced apart in the axial direction.
As shown in
The end of the connection section 241 away from the transition section 242 has an installation chamber 2415 with an increased inner diameter. The elastic ring 245 is located in the installation chamber 2415, and the lock cap 246 is threaded with the inner wall of the installation chamber 2415. The inner wall of the installation chamber 2415 has a step structure 2416. In the axial direction, the elastic ring 245 is clamped between the step structure 2416 and the lock cap 246, and the rest of the inner wall of the installation chamber limits the radial outward deformation of the elastic ring 245.
In order to prevent the valve from being exposed outside the crimping device, the length of the chamber 2431 is greater than or equal to the length of the valve in the expanded state. Further, in order to facilitate pre-loading, the transition section 242 and the extension section 243 are separate structures, and the junction of the two is located at the position of the chamber 2431 adjacent to the transition section 242.
An assembly indicator 2417 (such as a score or a scribe) is provided on the outer periphery of the connection section 241 at the distal side. The assembly indicator 2417 needs to be substantially aligned with the distal end surface of the outer sheath 50.
In the axis direction, the length of the chamber 2431 is L1, the length of the transition section 242 is L2, and L2:L1=2.0 to 3.0.
The maximum inner diameter of the chamber 2431 is D1, and the inner diameter of the junction of the two is D2, and D2:D1=1.0 to 1.5. The extension section 243 extends with a constant diameter. In order to facilitate connection, there is an extension area with a constant diameter between the transition section 242 and the extension section 243, where D2:D1=1. Alternatively, the extension section 243 can extend from the proximal end to the distal end with an enlarged diameter, but the overall diameter enlarging trend is slower than that of the transition section 242.
An embodiment of the present disclosure also provides an interventional instrument preloading and delivering system, including:
In this embodiment, the interventional instrument is located in the chamber and is in the expanded state, which is particularly suitable for a heart valve prosthesis device that is preserved with the valve dried, avoiding the disadvantages caused by long-time crimping after preloading in the prior art. The details of the other components can refer to the previous embodiments.
An embodiment of the present disclosure further provides an interventional instrument preloading and delivering assembly, in which a packaging component is provided in addition to the interventional instrument preloading and delivering system of the previous embodiments. The packaging component at least includes a carrying tray, and the carrying tray includes a tray body, the tray body has opposing top and bottom sides, the top side of the tray body has a recessed portion that forms an accommodation area, and the interventional instrument preloading and delivering system is located in the accommodation area. Referring to
A fixed mount 116 is provided in the liquid tank 111, and a matching structure is provided adjacent to the fixed mount 116 for detachable installation of an extension mount 117. The fixed mount 116 and the extension mount 117 both have positioning grooves 1113 that match the interventional instrument 90. The fixed mount 116 can be adapted to one or more types of interventional instruments 90, and the number of extension mounts 117 is selected according to different types of interventional instruments 90. Only the positioning grooves 1113 are different between the extension mounts 117. Therefore, one tray body 100 can be adapted to a plurality of models of interventional instruments, as long as the liquid tank 111 is large enough. Thus, only one large mold corresponding to the tray body 100 is required, which reduces the cost of die sinking compared with traditional packaging technologies.
In this embodiment, one tray body can be adapted to a plurality of extension mounts (corresponding to interventional instruments of different sizes), and the fixed mount of the tray body matched with the extension mounts can be adapted to one or more types of interventional instruments. Therefore, only one mold corresponding to the tray body is required, which reduces the cost of die sinking compared with traditional technologies. Moreover, there is no need to exert additional force during the preassembly and disassembly process of the delivering system, which at least avoids damage to the catheter component and the interventional instrument. The operator can load the interventional instrument while the delivering system is loaded in a blister box, which reduces the operator's error during loading and removal operations and improves efficiency.
The fixed mount 116 and the extension mount 117 can be made of the same or different materials as the tray body 100, such as PET (PETG, PETE) or PP.
In one embodiment, the matching structure includes:
As shown in
Continuing to refer to
The fixed mount 116 includes two limiting protrusions 1119 protruding from the liquid tank 111. A positioning groove 1113 of the fixed mount 116 is formed between the two limiting protrusions 1119. The extension mount 117 has two limiting grooves 1118 complementary to the limiting protrusions 1119. In order to protect the valve from damage during packaging, the interventional instrument delivering system includes a crimping device 240 for accommodating the interventional instrument 90. As shown in
The crimping device 240 includes a connection section 241 around the periphery of the catheter component 260, a transition section 242 for guiding the interventional instrument to be loaded into the catheter component, and an extension section 243 for receiving the interventional instrument in an expanded state, which are arranged from proximal to distal end. The extension section 243 covers the periphery of the interventional instrument 90 to prevent it from being exposed, thereby protecting the interventional instrument 90. The extension section 243 is provided with an opening for ice water to flow into and immerse the interventional instrument.
The catheter component 260 includes a guide head 261 extending distally from crimping device 240. The distal end of the guide head 261 is tapered to facilitate intervention in the human body. In order to facilitate the positioning and loading of the distal end of the catheter component 260, the distal end of the catheter component can be inserted through a support rod (such as the steel wire 262 in
The bottom wall of the liquid tank 111 is flat or inclined, and the liquid drain port 1110 is preferably at the lowest point.
In order to ensure the positioning effect, a plurality of limiting members 120 are detachably installed on the top side 101 of the tray body 100. At least a part of the limiting members 120 spans over the accommodation area 110 to limit the interventional instrument delivering system 2 to the accommodation area 110 for easy transportation. The limiting member 120 has at least two ends connected to the tray body 100, and one or both ends can be operated during assembly and disassembly. The shape, size, etc. of the limiting members 120 are adapted to accommodation areas 110 of different shapes.
For traditional trays, especially the accommodation area which the catheter component is adapted to is provided with protrusions. During pre-assembly or disassembly of the catheter component, external force is required to deform the protrusions and insert the same into or out of the accommodation area, which may cause damage to the catheter component, so the operator needs to be careful to avoid damaging the catheter component, making the operation laborious. By contrast, in the present disclosure, the delivering system can be pre-assembled or removed easily, and the operator only needs to disassemble the limiting members before the removal operation. After removing the limiting members, there is no obstruction above the delivering system, so no damage would be caused to the delivering system. The operator does not need to worry about damaging the delivering system, and accordingly the operating efficiency can be improved.
The limiting member 120 is in a strip shape, and its two ends have engagement structures that cooperate with the top side 101 of the tray body 100. The difference between the plurality of limiting members 120 mainly lies in the length, in order to span different accommodation areas 110 (with different heights). At least the middle portion (located above the accommodation area 110) of the limiting member 120 is flexible and bendable.
The engagement structure includes a snap-in groove (not shown) at the end of the limiting member 120 or the top side 101 of the tray body 100, and a snapping post 122 that matches the snap-in groove. The snapping post 122 is correspondingly located on the top side 101 of the tray body 100 or the end of the limiting member 120. According to an embodiment, the snapping post 122 corresponding to at least one end of the limiting member 120 is cylindrical, so the limiting member 120 only needs to be disassembled at one end and then rotated to release the restriction on the delivering system 2.
Referring to
As mentioned above, the accommodation area 110 has different shapes to adapt to different positions of the delivering system 2. The specific accommodation area 110 includes a handle accommodation area 112, a catheter component accommodation area 113 and an interventional instrument accommodation area 114 serving as the liquid tank 111. The catheter component accommodation area 113 is a long and narrow groove. Compared with the catheter component accommodation area 113, the width of the liquid tank is increased and the bottom is deepened, which prevents ice water from flowing into other accommodation areas and ensures sufficient ice water.
A guide portion 1131 is provided at the interface between the catheter component accommodation area 113 and the liquid tank 111 to guide the catheter component 260 into the accommodation area. The guide portion 1131 has a V-shaped structure that opens upward (i.e., the top side is opened) to guide the catheter component 260 during pre-assembly. After part of the catheter component 260 is pre-assembled into the corresponding accommodation area, the rest of the catheter component 260 is pre-assembled accordingly.
Considering the volume of the tray body 100 and the arrangement between the catheter component 260 and the interventional instrument 90, the ice water may flow into other accommodation areas when the interventional instrument is immersed. According to an embodiment, in the catheter component accommodation area 113, a sealing plug 1132 is provided adjacent to the liquid tank 111 to prevent the flow of ice water. The catheter component accommodation area 113 has a corresponding sealing plug accommodation area 115 that is further enlarged outward (by deepening and/or widening). The sealing plug 1132 is shaped as a column (such as a cuboid or a cylinder) that is formed by one or more pieces and engages with the sealing plug accommodation area 115, so as to be easily inserted around the outer periphery of the catheter component.
In order to ensure the sealing effect, in a preferred embodiment, one of the limiting members 120 spans across and acts on the top of the sealing plug 1132, to prevent the sealing plug 1132 from loosening.
There are three groups of limiting members 120, corresponding to the handle accommodation area 112, the catheter component accommodation area 113, and the interventional instrument accommodation area serving as the liquid tank 111 respectively. As shown in
The catheter component 260 includes a first section 2601 and a second section 2602 respectively connected to the control handle 60 and the interventional instrument 90, and a third section 2603 connected between the first section 2601 and the second section 2602. The first section 2601 and the second section 2602 are straight sections, and the third section 2603 is a curved section (the variation in the depth direction is not considered). Therefore, the length of the tray body 100 is not too long, and the length and width are appropriate, which facilitates packaging and transportation.
Therefore, the second group of limiting member includes at least three limiting members 120 respectively spanning across and acting on the first section, the second section and the third section. The catheter component accommodation area 113 is locally further recessed and extended outward to form an avoidance area 1191. The avoidance area 1191 allows a hand or tool to extend below the catheter component 260 and then lift the catheter component out of the accommodation area 110.
At least a part of the handle accommodation area 112 is further extended outward relative to the outer circumference of the control handle 60 to form an avoidance area 1121 relative to the control handle 60. In the traditional technologies, the control handle needs to be completely removed out for loading, while the other components are still in a pre-assembled state. The connection between the catheter component and the control handle is thus easy to be damaged, and the operator needs to be careful during the operation and thus the operation efficiency is low. By contrast, the avoidance area in this embodiment allows to operate the control handle for loading when the delivering system is pre-assembled or the control handle is partially removed. After loading is completed, the delivering system is removed.
As shown in
The catheter component 260 includes a catheter movably connected to the control handle 60, and the control handle 60 is provided with an operating portion 231 that can control the catheter. As shown in
Among them, the packaging box 105 is provided with a temperature display 106, and a corresponding temperature sensor is configured inside for monitoring the temperature inside the box.
Especially when the heart valve prosthesis is stored with the valve dried, it is easier to monitor the storage environment. Similarly, humidity or other parameters can also be monitored.
The interventional instrument preloading and delivering system in this disclosure can prevent the dry valve from being in a compressed state for a long time, and the overall system is easy to operate without the need for too much external tooling.
The technical features of the above embodiments can be arbitrarily combined, and not all possible combinations of the technical features of the above embodiments have been described for the sake of brevity of description. However, as long as there is no contradiction in the combination of these technical characteristics, such combination should be regarded as falling into the scope of this specification. When the technical features in different embodiments are shown in the same figure, it can be considered that the figure also discloses a combined embodiment of various embodiments involved.
The above-described embodiments only illustrate several embodiments of the present disclosure, and the description thereof is specific and detail, but should not be construed as limiting the scope of the patent disclosure. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present disclosure, all of which fall into the protection scope of the present disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202110705318.X | Jun 2021 | CN | national |
| 202111466057.7 | Dec 2021 | CN | national |
The present invention is a Continuation Application of PCT Application No. PCT/CN2022/101337, filed on Jun. 24, 2022, which claims the priorities of Chinese Patent Application No. 202110705318.X, filed on Jun. 24, 2021, and Chinese Patent Application No. 202111466057.7, filed on Dec. 3, 2021, the entire contents of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/CN2022/101337 | Jun 2022 | US |
| Child | 18395705 | US |
