Filling system and treatment system for abdominal aortic aneurysm

Abstract

The invention relates to an abdominal aortic aneurysm filling system and treatment system, the filling system comprises a filling assembly, the filling assembly comprises at least two filling blocks, each filling block adopts shape memory polymer foam, and each filling block has a compressed loading state and an implantation state of expanding at a preset position; the interventional catheter is used for containing the filling assembly to implement interventional delivery, and the filling blocks are sequentially arranged in the extending direction of the interventional catheter in the loading state; the connecting shaft is arranged in the interventional catheter in a sliding mode, the far-end portion of the connecting shaft sequentially penetrates through and is connected with the filling blocks so as to carry the filling blocks to be released from the far-end side of the interventional catheter into the abdominal aortic aneurysm, and the far-end portion of the connecting shaft is configured to be spirally wound around a space axis in a pre-shaping mode. The surgical operation process is simplified, the filling blocks are arranged relatively orderly after being released and expanded, the space filling rate is high, and the surgical treatment effect is further improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of vascular intervention treatment, in particular to an abdominal aortic aneurysm filling system and a treatment system. BACKGROUND

[0002] Minimally invasive intervention treatment has become a very important development direction in medical clinical treatment because of its small wound and fast recovery. Shape memory polymer (SMP) is a representative high polymer material, which can play a great role in minimally invasive intervention treatment, and is especially suitable for making filling components needed in vascular occlusion or vascular embolization treatment.

[0003] At present, shape memory polymer has been tried to be used in the occlusion treatment of abdominal aortic aneurysm as a filling component. However, in actual application, the internal space of abdominal aortic aneurysm is usually large. If multiple block-shaped shape memory polymers are used for filling, these filling components need to be released one by one, which is relatively cumbersome to operate. In addition, after these filling components are randomly stacked or pressed against each other during in-vivo release, the uniformity and filling rate of the filling are affected, which ultimately affects the treatment effect. SUMMARY

[0004] The present application provides a filling system which is simple to operate and can further optimize the space arrangement.

[0005] The abdominal aortic aneurysm filling system of the present application has opposite distal and proximal ends, and an axial direction extending between the proximal and distal ends. The abdominal aortic aneurysm filling assembly comprises: The filling assembly comprises at least two filling blocks, each of which is made of shape memory high polymer foam and has a compressed loading state and an implanted state of expansion in a preset position; An intervention catheter is used to accommodate the filling assembly to implement intervention delivery. Each of the filling blocks is arranged in sequence along the extension direction of the intervention catheter in the loading state; A connecting shaft is slidingly arranged in the intervention catheter. The distal end of the connecting shaft penetrates each of the filling blocks in sequence to carry each of the filling blocks to be released from the distal end of the intervention catheter into the abdominal aortic aneurysm. The distal end of the connecting shaft is configured in a pre-shaped manner to be spirally wound around a spatial axis.

[0006] Several optional modes are also provided below, but are not additional limitations on the above overall scheme, but are only further supplements or preferences. Without technical or logical contradictions, each optional mode can be combined with the above overall scheme alone, and can also be combined between multiple optional modes.

[0007] Optionally, the connecting shaft is made of nickel-titanium alloy, and in the pre-molding state, the diameter of the spiral winding is 5-10 cm, and the spiral winding is 1-3 turns and each turn is offset along the space axis.

[0008] Optionally, each of the filling blocks is an independent component, and in the loading state, each of the filling blocks is in a sheet shape and is wrapped around the outer periphery of the connecting shaft, and each of the filling blocks is arranged along the connecting shaft in sequence; The filling block wraps the connecting shaft for more than one turn, and the connecting shaft is arranged with multiple developing marks at intervals, and the positions of the developing marks correspond to each of the filling blocks.

[0009] Optionally, the delivery shaft is a heating section at a part in contact with the filling assembly in the loading state, or the filling system further comprises a non-contact heating device; The heating section and the heating device are used to change the temperature of the filling assembly to stimulate the expansion of the filling assembly to the implanted state.

[0010] Optionally, the filling assembly is tubular and fixedly sleeved on the connecting shaft, and the connecting shaft is entirely surrounded by the filling assembly and serves as an implant together with the filling assembly; The connecting shaft is arranged with a binding ring clamped on the outer periphery of the filling assembly, and the filling assembly is divided into multiple filling blocks by the binding ring.

[0011] Optionally, the filling system further comprises: A delivery tube slidingly arranged in the interventional catheter, the delivery tube is located at the proximal end side of the filling assembly, and is used to provide a distal side abutting force to the filling assembly during the release process; The proximal end of the connecting shaft is connected with a first ball, the delivery tube is provided with a pull wire, the distal end of the pull wire is provided with a second ball, and the filling assembly and the delivery tube have relative connection state and release state, wherein: In the connection state, the filling assembly is located outside the delivery tube and at the distal side, the first ball is placed in the delivery tube and at the proximal end of the second ball, and under the restraint of the delivery tube, the first ball is blocked by the second ball and remains in the delivery tube; In the release state, the first ball is allowed to pass the second ball distally to be separated from the delivery tube.

[0012] Optionally, the proximal end of the connecting shaft is connected with a first ball through an elastic wire, and in the implanted state, the elastic wire is wound by itself to make the first ball approach the connecting shaft; The proximal end of the connecting shaft serves as the elastic wire or the elastic wire is an independent component and is fixed to the proximal end of the connecting shaft.

[0013] Optionally, the delivery tube has a tube diameter smaller than the sum of the diameters of the first and second spheres, and a release hole is formed in the tube wall of the distal end portion of the delivery tube, the release hole having a hole diameter smaller than the diameter of the first sphere and smaller than the diameter of the second sphere; When released, the pull wire pulls the second sphere proximally relative to the delivery tube, causing the first sphere and the second sphere to move proximally until one of the first sphere and the second sphere at least partially enters the release hole, allowing the first sphere to be transferred from the proximal side of the second sphere to the distal side of the second sphere.

[0014] Optionally, the release hole is a strip-shaped hole spirally extending around the axis of the delivery tube, and in the axial view of the delivery tube, the distribution area of the release hole covers all areas in the circumferential direction of the delivery tube.

[0015] The application also provides an abdominal aortic aneurysm treatment system, which comprises an abdominal aortic covered stent and the filling system described in the application.

[0016] The application uses a pre-shaped connecting shaft, which can allow each filling block to be arranged around the main stem of the abdominal aortic covered stent after being introduced into the body, simplifying the surgical operation process, and allowing each filling block to be arranged in an orderly manner after being released and expanded, thereby improving the surgical treatment effect. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description only show some embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor based on these drawings.

[0018] Figure 1 A schematic view of the filling member being introduced into the abdominal aortic aneurysm one by one in the prior art; Figure 2 A partial schematic view of the filling assembly in the filling system in an embodiment of the application in a loaded state; Figure 3 A schematic view of the filling assembly in the filling system in another embodiment of the application in a loaded state; Figure 2 A schematic view of the filling assembly in the filling system in another embodiment of the application in a loaded state; Figure 4 A schematic view of the cooperation between the filling assembly and the connecting shaft in the filling system in another embodiment of the application; Figure 5 A schematic view of the cooperation between the filling assembly and the connecting shaft in the filling system in another embodiment of the application;Figure 4 A schematic diagram of the processing of one of the filling blocks; Figure 6 for Figure 5 A schematic diagram of the pre-shaping spatial attitude of the central connecting axis; Figure 7 This is a schematic diagram of an interventional catheter being inserted into an abdominal aortic aneurysm in a filling system according to an embodiment of this application; Figure 8 For the Figure 7 A schematic diagram of the interventional catheter release connection shaft and filling assembly; Figure 9 A schematic diagram showing the filling component filling the internal space of the abdominal aortic aneurysm. Figure 10 This is a schematic diagram showing the arrangement of filling components within an abdominal aortic aneurysm. Figure 11 This is a schematic diagram of the circuit principle for heating of the connecting shaft in a filling system according to an embodiment of this application; Figure 12 This is a schematic diagram of the circuit principle for heating of the connecting shaft in the filling system according to another embodiment of this application; Figure 13 This is a schematic diagram showing that, in one embodiment of this application, both the delivery tube and the filling assembly are located inside the interventional catheter and are in a connected state; Figure 14 for Figure 13 A partial schematic diagram showing the delivery tube and filling assembly in a detached state; Figure 15 This is a schematic diagram showing the positional relationship between the first sphere and its adjacent filling blocks. Figure 16 for Figure 14 Cross-sectional view of the delivery tube at the release port; Figure 17 for Figure 14 A diagram showing the delivery tube at the release port.

[0019] The component labels are as follows: 100. Abdominal aorta; 110. Abdominal aortic aneurysm; 120. Covered stent; 121. Main trunk; 122. Branch; 200. Filler assembly; 201. Filler block; 202. Bundle ring; 300, delivery tube; 301, release hole; 310, pull wire; 320, second sphere; 400. Interventional catheter; 401. First contrast marker; 500, Connecting shaft; 501, Second developing mark; 502, Core rod; 503, Resistance wire; 510, Elastic wire; 520, First sphere. Detailed Implementation

[0020] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a number of different ways beyond the specific embodiments described and it is therefore contemplated to cover all such modifications as fall within the scope of the application. It is to be understood that the description of the present application is meant to be illustrative only and not limiting as to the scope of the application.

[0021] It is to be understood that when an element such as a layer, film or region is referred to as being "on" or "connected to" another element, it can be directly on or connected to the other element or intervening elements can also be present. In contrast, when an element is referred to as being "directly on" or "directly connected to" another element, there are no intervening elements present. It will be understood that, although the terms "first", "second", etc. can be used herein to describe various elements, these elements should not be limited by these terms since such terms are only used to distinguish one element from another. The terms "first", "second", and the like, do not denote any order or importance, but rather are used to distinguish one element from another. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

[0022] In addition, the terms "first", "second", etc. are used herein only to describe various elements, and do not imply a relative importance or a specific order. Thus, a feature defined with "first", "second", etc. can implicitly or explicitly include at least one of the feature. In the description of the present application, the meaning of "a plurality of" is at least two, for example, two, three, etc., unless otherwise specifically defined.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The use of the terms "and / or" includes a combination of one or more of the associated listed items.

[0024] Referring to Figure 1 , for the abdominal aortic aneurysm 110 at the site of the abdominal aorta 100, a covered stent 120 can be implanted first, which includes a main stem 121 at the site of the abdominal aortic aneurysm 110 and two branches 122 below the main stem 121. When polyurethane SMP foam is used as the filling assembly 200, the filling assembly 200 is generally compressed and loaded in the interventional catheter 400 in advance, and delivered to the peripheral area of the main stem 121 through the interventional catheter 400. Since the filling assembly 200 generally uses multiple pieces, it may interfere with each other during the expansion process, resulting in an undesirable arrangement in space and making it difficult to achieve the desired effect.

[0025] To solve the problem, an embodiment of the present application provides a filling system for abdominal aortic aneurysm based on shape memory polymer material, which has opposite distal and proximal ends, and an axial direction extending between the proximal and distal ends. The proximal end generally refers to the side adjacent to the operator (e.g. doctor), and the distal end refers to the opposite side. Along the intervention path, each component has its own opposite distal and proximal ends. When the proximal and distal ends are in a straight line, the axial direction is determined, and the radial direction perpendicular to the axial direction and the circumferential direction around the axial direction are also determined. When referring to a structure, "end" and "side" in the text refer to the end point of the structure, a certain point or area in that direction, or a specific structure connected to that point or area.

[0026] Referring to Figures 2-7 The filling system of the embodiment includes a filling assembly 200, an intervention catheter 400, and a connecting shaft 500. The intervention catheter 400 is used to accommodate the filling assembly 200 in a loaded state. The intervention catheter 400 can be made of existing materials and is suitable for interventional delivery. The inner wall of the intervention catheter 400 can have a lubricating layer. A handle can be provided at the proximal end of the intervention catheter 400 as needed. The filling assembly 200 is loaded at the distal end of the intervention catheter 400. The filling assembly 200 can be released to the distal side of the intervention catheter 400 by relative movement with the intervention catheter 400 in the body.

[0027] The filling assembly 200 includes at least two filling blocks 201. Each filling block 201 is made of shape memory polymer foam and has a compressed loaded state and an implanted state expanded to a preset position. Each filling block 201 is arranged in sequence along the extension direction of the intervention catheter 400 in the loaded state. The material and preparation of the filling block 201 can be implemented in combination with existing technologies, such as polyurethane memory foam. At a relatively low temperature, the filling block 201 can maintain its current shape. In the body, it can expand to a preset state due to water and / or body temperature. For example, the polyurethane shape memory foam disclosed in Chinese Patent Document CN120550217A can be used. A polyurethane acrylate prepolymer can be prepared using a macromolecular polyol, a diisocyanate, a chain extender containing a disulfide bond, other small molecule chain extenders, and an acrylate end-capping agent. The polyurethane acrylate prepolymer, a foaming agent, a foaming aid, and a photoinitiator are mixed uniformly to form a foaming liquid. The foaming liquid is subjected to light curing and foaming in sequence to obtain the polyurethane shape memory foam. The expansion rate of the polyurethane shape memory foam can be 100-150 times.

[0028] The overall shape of the filling block 201 is not strictly limited, and can be adaptively processed according to the physiological structure of the to-be-filled part. For example, after complete inflation, it can be block-shaped, specifically cylindrical, circular-taipan-shaped, spherical, ellipsoidal, or even various special-shaped. The interior of the filling block 201 is a porous structure, so the volume can be changed by compression to adapt to loading and delivery through a catheter. The filling block 201 inflates in the body and occupies the space of the implantation site, achieving the effect of plugging and embolization. During use, the filling block 201 generally includes, in order from small to large relative volume in the common state: a compressed loading state, for example, being accommodated in an interventional catheter 400 for interventional delivery; an inflation state in a preset position, for example, in the abdominal aortic aneurysm 110, after the filling block 201 is further inflated to complete implantation relative to the loading state, it can be understood as being compressed slightly under the action of the surrounding tissue. Due to the further inflation tendency, there is an interaction force between the filling block 201 and the surrounding tissue and tension is maintained in the implantation site; a completely inflated preset state, which can be understood as the maximum volume that the filling block 201 can inflate under the condition that the surrounding is not pressed.

[0029] In terms of volume, the preset state can be 50-100 times the loading state. In some cases, the axial length of the filling assembly 200 is basically unchanged between the preset state and the loading state, and only the radial outer diameter is expanded by about 10 times.

[0030] The connecting shaft 500 is slidingly arranged in the interventional catheter 400. The distal end of the connecting shaft 500 penetrates each filling block 201 in turn, and is used to carry each filling block 201 to be released from the distal end of the interventional catheter 400 into the abdominal aortic aneurysm. In this application, the distal end of the connecting shaft 500 is configured to be helically wound around a space axis in a pre-shaped manner, and each filling block 201 is attached to the pre-shaped part. The distal end of the connecting shaft 500 can be made of a memory metal, such as a nickel-titanium alloy material, which is pre-shaped by a heat treatment process. During interventional delivery, the connecting shaft 500 is generally straightened and introduced into the interventional catheter 400. After being separated from the interventional catheter 400 in the body, it tends to be pre-shaped in the body temperature environment. In combination with its application scenario, the distal end of the connecting shaft 500 can be helically wound around the outer periphery of the main stem 121 of the covered stent 120 and axially offset along the main stem 121 by one turn. This provides a better initial position for each filling block 201. After the filling block 201 is helically distributed around the outer periphery of the main stem 121, it gradually inflates to the implantation state. Based on this, all the filling blocks 201 can obtain a more ideal distribution trend, improving the degree of sparse distribution in the abdominal aortic aneurysm 110.

[0031] Referring to Figure 2 , Figure 3The filling assembly 200 of one embodiment of the present application is fixedly connected with the connecting shaft 500, both of which remain in the body as implants. In this embodiment, the filling assembly 200 can be pre-processed into a tubular shape and sleeved on the connecting shaft 500, or the connecting shaft 500 can be a pre-embedded part in the mold when the filling assembly 200 is prepared, and the connecting shaft 500 is entirely surrounded by the filling assembly 200 to improve safety. In the loaded state (radially compressed to a volume comparable to the loaded state), the spaced tightening bands 202 each tightly fix the corresponding part of the filling assembly 200 to the outer periphery of the connecting shaft 500, and the filling assembly 200 is divided into a plurality of filling blocks 201 by the bands 202. Figure 3 In the preset state, the bands 202 form a reduced diameter part between adjacent filling blocks 201, which is beneficial for turning and coiling in space to change the orientations and angles of the two adjacent filling blocks 201 to each other.

[0032] Referring to Figure 5 In another embodiment of the present application, each filling block 201 is an independent component, for example, in a preset state, it is in a cylindrical shape, and after being compressed along one radial direction, it is in a sheet shape, and in the loaded state, it is wrapped around the outer periphery of the connecting shaft 500. Each filling block 201 is arranged along the connecting shaft 500 in sequence. In order to avoid unintended loosening, the filling block 201 is wrapped around the connecting shaft 500 at least once, for example, after being wrapped 1.5 times, the head and tail are placed together, which can ensure that before swelling, it can move with the connecting shaft 500 to release the interventional catheter 400 and reach the intended implantation position. In this embodiment, in order to observe the position of the filling block 201, a radiographic marker can be arranged in the interior of each filling block 201, and a plurality of radiographic markers can be arranged on the connecting shaft 500 in sequence, and the positions of the radiographic markers correspond to each filling block 201.

[0033] Figure 6 It can be seen that the distal end of the interventional catheter 400 can be provided with a first radiographic marker 401, which is convenient for real-time monitoring by using an imaging device. The connecting shaft 500 is made of nickel-titanium alloy and is arranged in the interventional catheter 400. The distal end of the connecting shaft 500 can be provided with a second radiographic marker 501, and a plurality of radiographic markers can also be arranged at other positions. In the pre-shaped state, the diameter of the spiral coil is 5-10 cm, and the spiral coil is 1-3 turns, and each turn is offset along the space axis.

[0034] Referring to Figures 7-10 In one embodiment of the present application, the process of releasing the filling assembly 200 into the abdominal aortic aneurysm 110 is as follows: Figure 7In the middle, the intervention catheter 400 enters the abdominal aortic aneurysm 110 via the side of the branch, and the space above the distal end of the intervention catheter 400 in the figure is reserved for the implantation of the filling assembly 200.

[0035] Figure 8 In the middle, the connecting shaft 500 carries a plurality of filling blocks 201 out of the intervention catheter 400, and the connecting shaft 500 then tends to its pre-shaped state, and gradually releases itself, and is spirally wound around the outer periphery of the main stem of the covered stent, generally about 1-2 turns around the main stem, and the plurality of filling blocks 201 also reach the ideal implantation position with the connecting shaft 500.

[0036] Figure 9 In the middle, each filling block 201 completes the expansion and release, and the release position is distributed around the main stem and in the implanted state. Generally, the filling assembly 200 can include 3-10 filling blocks 201, and in some cases, the first filling assembly 200 has completed the release and expansion, but the abdominal aortic aneurysm 110 is not yet filled, and another filling assembly 200 with a suitable number of filling blocks can be selected for the second filling, that is, after the release of one filling assembly 200 is completed, the intervention catheter 400 is withdrawn to the outside of the body and the next filling assembly 200 is filled, and different filling assemblies 200 can be the same or different number of filling blocks 201, and the release position of each filling assembly 200 is distributed around the main stem.

[0037] Figure 10 In the middle, after the filling block 201 completes the release and expansion in the abdominal aortic aneurysm 110, due to the regular release position of the filling block 201, the distribution posture around the main stem 121 and the filling effect are greatly improved.

[0038] In Figure 4In the shown embodiment, the connecting shaft 500 is not the final implant, but only an interventional delivery instrument, so the proximal end of the connecting shaft 500 extends to the outside of the body as a control end, and can also be connected to the proximal end of the interventional catheter 400 together with the handle and controlled by the handle. Since the filling block 201 is only wound around the outer periphery of the connecting shaft 500, the starting time of the control of the expansion in the body needs to be controlled, otherwise it is possible to be detached from the connecting shaft 500 before reaching the implantation position, and cannot form an orderly arrangement in space. In order to further control the starting time, the SMP foam with a higher Tg can be selected, for example, Tg is 45℃~62℃, and for example, about 60℃, the expansion speed is slightly slower in a simple body temperature environment, providing sufficient operation time for the operation, and when the filling block 201 needs to be expanded, the connecting shaft 500 can quickly trigger the expansion of the filling block 201 by heating. For safety considerations, the temperature upper limit of the heating of the connecting shaft 500 can be set, for example, not higher than 50℃, and for example, not higher than 45℃. At this temperature, combined with the water absorption and permeation of the filling block 201, the filling block 201 can quickly expand, for example, in 15s~30s, the filling block 201 can be expanded to the implantation state to complete the positioning in the body, and then the interventional catheter 400 and the connecting shaft 500 are withdrawn to the outside of the body. In order to control the temperature, the power and the power-on time can be set according to the empirical data, and further, a temperature detection element can be configured to detect the temperature signal around the connecting shaft 500 in real time and feedback. In the embodiment, each filling block 201 is wrapped around the connecting shaft 500, and can be uniformly heated, so that the expansion time is more synchronous.

[0039] Referring to Figure 11 In an embodiment of the present application, the connecting shaft 500 (the distal end part is shown) is a resistance wire itself, which forms a loop by turning back at the distal end, and the two ends of the resistance wire extend to the proximal end and are connected to the positive and negative electrodes of the power supply respectively.

[0040] Referring to Figure 12 In another embodiment of the present application, the connecting shaft 500 includes a core rod 502 and a resistance wire 503 wrapped around the outer periphery of the core rod 502, the resistance wire 503 is twisted and wrapped around and turns back at the distal end to form a loop, and the two ends of the resistance wire 503 extend to the proximal end and are connected to the positive and negative electrodes of the power supply respectively.

[0041] In each embodiment, a coating layer can be further provided on the outer periphery of the resistance wire 503 as a whole, which can fix the resistance wire 503 and also consider the overall mechanical properties. As for the heating driving circuit itself, it can be implemented in combination with the prior art.

[0042] In other embodiments of the present application, the filling system can also include a non-contact heating device, that is, not by heating the connecting shaft 500, but by using an external device, using ultrasonic waves and the like, and cooperating with the predetermined depth of action in the body to heat each filling block 201, and each filling block 201 can also be uniformly heated and expanded synchronously.

[0043] Figure 2In the embodiment shown, since the connecting shaft 500 is the final implant, in order to push the connecting shaft 500 outwardly in the interventional catheter 400, and facilitate the control of the release timing, see Figures 13-17 In another embodiment of the present application, the filling system further comprises a delivery tube 300 slidingly arranged in the interventional catheter 400, the delivery tube 300 is inserted into the interventional catheter 400 from the proximal end and extends to the vicinity of the proximal side of the filling assembly 200 for providing a distal side abutting force to the filling assembly 200 during the release process, The delivery tube 300 and the filling assembly 200 and the connecting shaft 500 can be simply abutting, or can be provided with a mutual adaptive release structure, that is, the delivery tube 300 can also pull the filling assembly 200 back to the proximal end to adjust the posture and accurately control the release timing, and can also be recycled in real time when necessary.

[0044] The proximal end of the connecting shaft 500 is connected with a first ball 520 through an elastic wire 510, in the preset state and the implanted state, the elastic wire 510 is wound by itself (similar to a helical spring, such as Figure 15 ) to make the first ball 520 close to or abut against the end of the connecting shaft 500, avoiding too long trailing in the body. The delivery tube 300 is provided with a pull wire 310, and the distal end of the pull wire 310 is provided with a second ball 320, the first ball 520 and the second ball 320 can be metal balls and have the same ball diameter, and the metal balls can also be used as development marks.

[0045] The filling assembly 200 and the delivery tube 300 have relative connection state and release state, wherein: In the connection state, as Figure 13 , the filling assembly 200 is located outside the delivery tube 300 and at the distal side, the first ball 520 is placed in the delivery tube 300 and at the proximal end of the second ball 320, the second ball 320 is kept in the current axial position under the action of the pull wire 310, and the first ball 520 is blocked by the second ball 320 and kept in the delivery tube 300 under the restraint of the delivery tube 300; In the release state, as Figure 14 , the delivery tube 300 is released from the restraint, allowing the first ball 520 to pass the second ball 320 to escape from the delivery tube 300, that is, the release of the filling assembly 200 can be realized.

[0046] The proximal end of the pull wire 310 is an operation end, and the proximal end of the delivery tube 300 can be provided with an end cap. The operation end of the pull wire 310 is inside the delivery tube 300 and fixed to the end cap. The end cap is connected to other parts of the delivery tube 300 through a breakable part. In use, the delivery tube 300 and the end cap encapsulate the proximal end of the pull wire 310 inside, avoiding misoperation. When it is necessary to drive the pull wire 310 to move relative to the delivery tube 300, the breakable part can be broken or pulled to allow the end cap to pull the pull wire 310 and the second ball 320 proximally relative to the delivery tube 300.

[0047] In the embodiment, the delivery tube 300 is provided with a release hole 301 on the wall thereof. Of course, the diameter of the delivery tube 300 at the distal end is smaller than the sum of the diameters of the first ball 520 and the second ball 320. In the connected state, it is difficult for the second ball 320 and the first ball 520 to be misaligned with each other through the restraint of the delivery tube 300, i.e., the first ball 520 cannot pass the second ball 320 distally.

[0048] When it is necessary to release, the pull wire 310 pulls the second ball 320 proximally relative to the delivery tube 300, so that the first ball 520 and the second ball 320 move proximally together until one of the first ball 520 and the second ball 320 partially enters the release hole 301, which can reduce the interference with the other. At this time, the inner cavity of the delivery tube 300 allows the second ball 320 and the first ball 520 to be misaligned with each other, i.e., in the released state, allowing the first ball 520 to pass the second ball 320 distally, so that the first ball 520 and the filling assembly 200 are separated from the delivery tube 300, achieving the release of the filling assembly 200.

[0049] In the connected state, since the first ball 520 is on the proximal side of the second ball 320, in the implementation of the release, generally, the first ball 520 enters the release hole 301 first to avoid the second ball 320 from moving further proximally, until the first ball 520 and the second ball 320 are misaligned with each other. However, since the first ball 520 and the second ball 320 abut each other, in some cases, the second ball 320 can enter the release hole 301 first to avoid the first ball 520 from moving distally, until the first ball 520 and the second ball 320 are misaligned with each other.

[0050] Referring to Figure 16 , Figure 17 In another embodiment of the present application, in order to ensure accurate release, 2-4, for example, 3 release holes 301 are arranged circumferentially along the delivery tube 300. The release hole 301 is a strip-shaped hole (an inclined strip-shaped hole after unfolding) spirally extending around the axis of the delivery tube 300 and has a relative length and width. The width of the release hole 301 is smaller than the diameters of the first ball 520 and the second ball 320, so as to limit the first ball 520 and the second ball 320 from exiting the release hole.

[0051] The central angle of the position where each release hole 301 is located is 60-150 degrees, for example, the area (horizontal direction in the figure) spanned by each release hole 301 in the expanded view is greater than 1 / 3 of the area spanned by the delivery tube 300, and also makes the positions of all release holes 301 cover all areas in the circumferential direction of the delivery tube 300. The first sphere 520 and the second sphere 320 abut against the tube wall at any position in the circumferential direction, at least one of them will contact and fall into the release hole 301 during the process of moving axially to the proximal end, completely avoiding the possibility of release failure, improving the convenience and safety of operation.

[0052] The technical features of the above embodiments can be combined in any way. To make the description concise, not all possible combinations of the technical features in the above embodiments are described, but as long as the combinations of the technical features do not contradict, they should be considered as within the scope of the present disclosure. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of each embodiment involved.

[0053] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the patent scope of the application. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are all within the protection scope of the present application. Therefore, the patent protection scope of the present application should be subject to the appended claims.

Claims

1. A filling system for an abdominal aortic aneurysm, having opposing distal and proximal ends, and an axial extension between said proximal and distal ends, characterized in that, The filling system includes: The filling component includes at least two filling blocks, each of which is made of shape memory polymer foam and has a compressed loading state and an implanted state that is expanded at a preset position. An interventional catheter is used to accommodate the filling assembly for interventional delivery, wherein the filling blocks are arranged sequentially along the extension direction of the interventional catheter in the loaded state; A connecting shaft is slidably disposed within the interventional catheter. The distal end of the connecting shaft is sequentially connected to each of the filling blocks to carry each of the filling blocks from the distal end of the interventional catheter into the abdominal aortic aneurysm. The distal end of the connecting shaft is pre-shaped and configured to spirally coil around a spatial axis.

2. The abdominal aortic aneurysm filling system as described in claim 1, characterized in that, The connecting shaft is made of nickel-titanium alloy. In the pre-shaped state, the diameter of the spiral is 5~10cm, and the spiral is wound 1 to 3 times with each turn offset along the spatial axis.

3. The abdominal aortic aneurysm filling system as described in claim 1, characterized in that, Each of the filling blocks is an independent component. In the loaded state, it is sheet-like and wrapped around the outer periphery of the connecting shaft. Each of the filling blocks is arranged sequentially along the connecting shaft. The filler block is wound around the connecting shaft more than once, and multiple developing marks are arranged at intervals on the connecting shaft, with the positions of the developing marks corresponding to each of the filler blocks.

4. The abdominal aortic aneurysm filling system as described in claim 3, characterized in that, The delivery shaft is a heating section in contact with the filling assembly in the loaded state, or the filling system may also include a non-contact heating device. The heating section and the heating device are used to change the temperature of the filling component to stimulate the filling component to expand towards the implantation state.

5. The abdominal aortic aneurysm filling system as described in claim 1, characterized in that, The filling component is tubular and fixedly sleeved on the connecting shaft. The connecting shaft is entirely surrounded by the filling component, and both the connecting shaft and the filling component serve as implants. The connecting shaft is provided with a clamping ring at intervals, which clamps the outer periphery of the filling component, and the filling component is divided into multiple filling blocks by the clamping ring.

6. The abdominal aortic aneurysm filling system as described in claim 5, characterized in that, The filling system also includes: A delivery tube is slidably inserted within the interventional catheter, the delivery tube being positioned on the proximal side of the filling assembly, for providing a counterforce toward the distal side to the filling assembly during release; The proximal end of the connecting shaft is connected to a first sphere, the delivery tube contains a pull wire, the distal end of the pull wire is provided with a second sphere, and the filling assembly and the delivery tube have relative connected and disengaged states, wherein: In the connected state, the filling component is located outside the delivery tube and at the distal end, the first ball is placed inside the delivery tube and at the proximal end of the second ball, and under the constraint of the delivery tube, the first ball is blocked by the second ball and held inside the delivery tube; In the disengaged state, the first sphere is allowed to pass the second sphere to the distal end to detach from the delivery tube.

7. The abdominal aortic aneurysm filling system as described in claim 6, characterized in that, The first sphere is connected to the proximal end of the connecting shaft by an elastic wire. In the implanted state, the elastic wire itself is wound around to bring the first sphere closer to the connecting shaft. The proximal portion of the connecting shaft also serves as the elastic wire, or the elastic wire is an independent component and fixed to the proximal end of the connecting shaft.

8. The abdominal aortic aneurysm filling system as described in claim 6, characterized in that, The diameter of the delivery tube is smaller than the sum of the diameters of the first sphere and the second sphere. A release hole is provided on the tube wall at the distal end of the delivery tube. The diameter of the release hole is smaller than the diameters of the first sphere and the second sphere. Upon release, the pull wire pulls the second ball proximally relative to the delivery tube, causing the first ball and the second ball to move proximally until at least one of the first ball and the second ball partially enters the release hole, allowing the first ball to be transferred from the proximal side of the second ball to the distal side of the second ball.

9. The abdominal aortic aneurysm filling system as described in claim 8, characterized in that, The release hole is a strip-shaped hole that extends spirally around the axis of the delivery tube. From the perspective of the delivery tube axis, the distribution area of ​​the release hole covers all areas of the delivery tube in the circumferential direction.

10. A treatment system for abdominal aortic aneurysm, characterized in that, Including abdominal aortic endovascular stent grafts, and the filling system according to any one of claims 1 to 9; The abdominal aortic endovascular stent graft includes a main trunk located within the abdominal aortic aneurysm in the implanted state, and two branches connected to the main trunk, with the connecting shaft spirally coiled around the main trunk in a pre-shaped state.

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