A delivery device and delivery system
By designing a delivery device that includes a perforation guidewire and a delivery system, fenestration of the covered stent and connection of branch vessels were achieved in the treatment of aortic aneurysms and aortic dissections. This solved the problems of multiple entry and exit from the body and embolus dislodgement in existing technologies, and improved the safety and efficiency of the operation.
Patent Information
- Application Number
- CN202310826218.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2023-07-06
- Publication Date
- 2025-11-18
- Estimated Expiration
- 2043-07-06
AI Technical Summary
Existing in-situ fenestration techniques require multiple entry and exit procedures when treating aortic aneurysms and aortic dissections, involving numerous steps and the potential risk of emboli dislodging.
A delivery device was designed, including a perforation guidewire and a delivery device. The perforation guidewire is used to puncture the covered stent, and combined with a movable filter and sheath, the fenestration of the covered stent and the connection of branch vessels can be completed in one go, protecting the distal vessels.
It eliminates the need for multiple entry and exit from the human body, simplifies the operation, reduces the risk of embolus dislodgement, and improves the safety and efficiency of the operation.
Smart Images

Figure CN119302785B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a delivery device and delivery system. Background Technology
[0002] The aortic arch is the arched, curved portion of the upper aorta. Three major branch arteries emerge from the convex side of the aortic arch: the brachiocephalic artery, the left common carotid artery, and the left subclavian artery, from right to left. When aortic aneurysms or aortic dissections occur in the aortic arch, the vessel wall thins, and if not treated promptly, it may rupture at any time. Currently, the main treatments for aortic aneurysms and aortic dissections are open surgery and endovascular repair. Compared to open surgery, endovascular repair is less invasive, involves less bleeding, has a faster recovery, and a lower mortality rate. Endovascular repair typically involves releasing a covered stent graft in the diseased area of the vessel to isolate the aortic aneurysm and aortic dissection. Because the aortic arch connects to the three major branch arteries, after releasing the covered stent graft in the aortic arch, it is necessary to create an in-situ fenestration on the covered stent graft corresponding to the location of the branch artery, or to directly create a perforation on the covered stent graft.
[0003] Current in-situ fenestration techniques typically involve first using a fenestration instrument to create an in-situ fenestration of the covered stent, then inserting a guidewire, withdrawing the fenestration instrument, inserting a stent delivery device along the guidewire, and finally releasing the branched stent. Existing in-situ fenestration techniques require multiple insertions and removals of the medical device from the body, involving numerous steps. Excessive manipulation can easily cause emboli in the diseased blood vessel to dislodge and travel to the brain via the bloodstream, posing a potential danger. Summary of the Invention
[0004] Therefore, it is necessary to provide a delivery device that is easy to operate and also protects distal blood vessels.
[0005] This invention provides a conveying device for conveying a lumen support, the conveying device comprising: a membrane rupture guide wire and a conveyor;
[0006] The delivery device includes an inner sheath, a delivery sheath, a filter element, and an outer sheath arranged from the inside out; there is a space between the outer peripheral surface of the sheath and the inner wall surface of the delivery sheath for accommodating a lumen support; the outer sheath and the filter element are movable relative to each other to release or retract the filter element;
[0007] The membrane-perforating guidewire is movably disposed within the sheath core; the membrane-perforating guidewire includes a guidewire body and a membrane-perforating needle, the membrane-perforating needle is movably disposed within the guidewire body, and the membrane-perforating needle can extend beyond the distal end of the guidewire body to pierce the membrane on the membrane-covered stent under the action of external force.
[0008] In some embodiments, the conveyor further includes a conveying handle, which includes a fixed handle and a movable handle; the movable handle is disposed near the proximal end of the fixed handle and is axially movable relative to the fixed handle;
[0009] The proximal end of the outer sheath and the proximal end of the filter element are connected to the fixed handle, and the proximal end of the delivery sheath and the proximal end of the sheath core are connected to the movable handle.
[0010] In some embodiments, the conveying handle further includes a connector sleeved on the distal end of the movable handle; the distal end of the connector is threadedly connected to the proximal end of the fixed handle, and the proximal end of the connector is rotatably connected to the distal end of the movable handle.
[0011] In some embodiments, the filter element includes a filter screen and a frame. The filter screen has a proximal opening and a distal opening, the distal opening communicating with the lumen of the outer sheath through the proximal opening. The frame includes a traction wire, a proximal support ring, and a distal support ring. The proximal support ring is connected to the proximal opening of the filter screen, the distal end of the traction wire is connected to the proximal support ring, and the proximal end of the traction wire is connected to the fixed handle.
[0012] In some embodiments, the guidewire body includes a tube body and a protective sleeve, the protective sleeve being disposed at the distal end of the tube body;
[0013] The protective sleeve has an open state and a closed state. When the protective sleeve is in the open state, the protective sleeve has a distal opening, through which the membrane-breaking needle can pass through the guidewire body.
[0014] In some embodiments, the protective sleeve is made of a soft material and changes from a closed state to an open state when squeezed by the rupture needle.
[0015] In some embodiments, the protective sleeve includes two protective arms and two connecting arms, the two protective arms being at least partially exposed at the distal end of the tube body;
[0016] The two protective arms are hinged together, and the space between the distal ends of the two protective arms is used to accommodate the distal end of the membrane-breaking needle. The proximal ends of the two protective arms are respectively hinged to the distal ends of the two connecting arms, and the proximal ends of the two connecting arms are hinged to the membrane-breaking needle. When the membrane-breaking needle moves to the distal end, the distal ends of the two protective arms move away from each other and expose the distal end of the membrane-breaking needle.
[0017] In some embodiments, the delivery device further includes a guide wire handle detachably connected to the membrane breaking guide wire, the guide wire handle including a handle body and a locking cap;
[0018] The proximal end of the membrane-breaking guidewire is disposed within the handle body; the locking cap is fitted onto the distal end of the handle body, and under the action of external force, the distal end of the handle body clamps or releases the membrane-breaking guidewire.
[0019] In some embodiments, the guidewire handle further includes a button movably connected to the proximal end of the handle body;
[0020] The button is connected to at least the perforation needle of the perforation guidewire to drive the perforation needle to move relative to the guidewire body.
[0021] In some embodiments, the guidewire body includes a tubular portion, an elastic portion, and a connecting portion connected in sequence; the membrane-breaking needle passes through the tubular portion and the elastic portion, and the proximal end of the membrane-breaking needle is fixedly connected to the connecting portion;
[0022] The connecting part is detachably connected to the button, and the button is used to squeeze the elastic part and cause the rupture needle to extend from the distal end of the tube body.
[0023] In some embodiments, the button includes a button body and at least two elastic portions; the at least two elastic portions are circumferentially disposed at the distal end of the button body, and the at least two elastic portions enclose a cavity for accommodating the connecting portion of the guidewire body;
[0024] The outer peripheral surface of the elastic part is provided with a protrusion, and the inner wall of the handle body is provided with a groove. When the protrusion is facing the groove, the cavity is in an open state, and the connecting part can enter the cavity. When the protrusion is disengaged from the groove, the elastic part undergoes elastic deformation and converges inward along the radial direction of the button body, the cavity is in a closed state, and the connecting part is locked in the cavity.
[0025] The delivery device of this invention utilizes a perforation guidewire to puncture the covered stent. During the procedure, the perforation guidewire is first inserted to the desired fenestration position. After the delivery device reaches the target position along the perforation guidewire, a filter is deployed to protect the distal end of the blood vessel. Subsequently, the perforation guidewire is used to puncture the covered stent, and finally, the delivery device releases the stent to connect the aortic arch and branch vessels. This delivery device eliminates the need for multiple insertions and removals from the body during in-situ fenestration procedures, while also protecting distal blood vessels.
[0026] The present invention also provides a conveying system, the conveying system including the above-described conveying device, the conveying system further including a lumen support, the lumen support being disposed between the sheath core and the conveying sheath tube. Attached Figure Description
[0027] Figure 1 This is a front view of the conveying device according to Embodiment 1 of the present invention;
[0028] Figure 2 This is a partial front view of the conveyor of Embodiment 1 of the present invention;
[0029] Figure 3 This is a partial cross-sectional view of the membrane-breaking guidewire of Embodiment 1 of the present invention (with the protective sleeve in a closed state);
[0030] Figure 4 This is a schematic diagram of the delivery device of Embodiment 1 of the present invention placed inside the aorta;
[0031] Figure 5 This is a front view of the handle of Embodiment 1 of the present invention;
[0032] Figure 6 This is a cross-sectional view of the handle of Embodiment 1 of the present invention;
[0033] Figure 7 for Figure 6 Enlarged view of point A in the middle;
[0034] Figure 8 This is a front view of the delivery handle according to another embodiment of the present invention;
[0035] Figure 9 This is a schematic diagram showing the connection between the filter element and the outer sheath tube in Embodiment 1 of the present invention;
[0036] Figure 10 This is a front view of the frame of Embodiment 1 of the present invention;
[0037] Figure 11 This is a partial cross-sectional view of the membrane-breaking guidewire of Embodiment 1 of the present invention (with the protective sleeve in the open state);
[0038] Figure 12 This is a partial cross-sectional view of the guidewire body according to another embodiment of the present invention;
[0039] Figure 13 This is a cross-sectional view of the guide wire handle of Embodiment 1 of the present invention;
[0040] Figure 14 for Figure 13 Enlarged view of point B in the middle;
[0041] Figure 15 This is a perspective view of the button in Embodiment 1 of the present invention;
[0042] Figure 16 This is a cross-sectional view of the guide wire handle of Embodiment 1 of the present invention;
[0043] Figure 17 This is a cross-sectional view of the guide wire handle of Embodiment 1 of the present invention;
[0044] Figure 18 This is a partial perspective view of the membrane-breaking guidewire of Embodiment 2 of the present invention;
[0045] Figure 19 This is a partial perspective view of the membrane-breaking needle and protective sleeve of Embodiment 2 of the present invention;
[0046] Figure 20 This is a perspective view of the filter element in Embodiment 3 of the present invention;
[0047] Figure 21 This is a test schematic diagram of the filter element in Embodiment 3 of the present invention;
[0048] Figure 22 This is a cross-sectional view of the filter element in Embodiment 3 of the present invention when it is inside the head arm dry (the first and second filter screens are transparent, and the obscured parts are shown in dashed lines).
[0049] Figure 23 This is a left view of the filter element in Embodiment 3 of the present invention (the first and second filters are transparent, and the obscured parts are shown in dashed lines);
[0050] Figure 24 This is a schematic diagram showing the length ratio of the first sub-filter and the second sub-filter in Embodiment 3 of the present invention (the second filter screen is transparent, and the obscured part is shown in dashed lines).
[0051] Figure 25 This is a perspective view of the filter element in Embodiment 3 of the present invention (the first and second filter screens are transparent, and the obscured parts are shown in dashed lines);
[0052] Figure 26 This is a perspective view of the first and second frames of Embodiment 3 of the present invention;
[0053] Figure 27 This is a perspective view of a filter element according to another embodiment of the present invention;
[0054] Figure 28 This is a perspective view of a first filter screen according to another embodiment of the present invention. Detailed Implementation
[0055] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.
[0056] 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 invention pertains. The terminology used herein in the specification of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.
[0057] To more clearly describe the structure of the present invention, the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end that is far away from the operator during the operation, and "proximal" refers to the end that is close to the operator during the operation.
[0058] Example 1
[0059] like Figure 1 As shown, the conveying device 100 of this embodiment includes a conveyor 10 and a membrane breaking guide wire 20.
[0060] like Figure 2 As shown, the delivery device 10 includes a sheath core 11, a delivery sheath 12, a filter element 13, and an outer sheath 14 arranged from the inside to the outside; there is a space between the outer peripheral surface of the sheath core 11 and the inner wall surface of the delivery sheath 12 for accommodating a lumen support; the outer sheath 14 and the filter element 13 can move relative to each other to release or retract the filter element 13.
[0061] The membrane-breaking guidewire 20 is movably disposed within the sheath core 11, such as... Figure 3 As shown, the membrane-perforating guidewire 20 includes a guidewire body 21 and a membrane-perforating needle 22. The membrane-perforating needle 22 is movably disposed within the guidewire body 21, and under the action of external force, the membrane-perforating needle 22 can extend beyond the distal end of the guidewire body 21 to pierce the membrane on the membrane-covered stent.
[0062] The delivery device 100 of this invention utilizes a perforation guidewire 20 to puncture the covered stent. During operation, the perforation guidewire 20 is first inserted to the desired fenestration position. After the delivery device 10 reaches the target position along the perforation guidewire 20, the filter element 13 is deployed to protect the distal end of the blood vessel. Subsequently, the perforation guidewire 20 is used to puncture the covered stent, and finally, the delivery device 10 releases the stent to achieve communication between the aortic arch and branch vessels. The delivery device 100 of this invention eliminates the need for multiple insertions and removals from the body during in-situ fenestration operations, while also protecting distal blood vessels. For example, as... Figure 4As shown, after the aortic arch endovascular stent graft 300 is released into the aortic arch 1, the delivery device 100 of the present invention enters the brachiocephalic trunk 3 via the right subclavian artery 2. When the distal end of the delivery device 100 reaches the aortic arch endovascular stent graft 300, the filter element 13 is released first, then the aortic arch endovascular stent graft 300 is fenestrated in situ, and finally the branch stent 200 is released to realize the connection between the brachiocephalic trunk 3 and the aortic arch 1.
[0063] The aortic arch endovascular stent graft 300 includes a frame and a graft. The graft is preferably made of a highly elastic material, such as silicone film, PU film, PA film, or PTFE film. Alternatively, the graft may have a localized elastic graft corresponding to the branch vessel, allowing the expansion force of the branch stent 200 itself to open the puncture hole formed by the perforation needle 22. Furthermore, after the branch stent 200 is released, the elastic graft adheres tightly to the outer periphery of the branch stent 200, providing good sealing.
[0064] like Figure 5 and Figure 6 As shown, the conveyor 10 further includes a conveying handle 15, which includes a fixed handle 151 and a movable handle 152. The movable handle 152 is disposed at the proximal end of the fixed handle 151 and is axially movable relative to the fixed handle 151. The proximal ends of the outer sheath tube 14 and the filter element 13 are connected to the fixed handle 151, and the proximal ends of the conveying sheath tube 12 and the sheath core 11 are connected to the movable handle 152.
[0065] In this embodiment, as Figure 6As shown, an outer sheath drive assembly 153 is disposed within the fixed handle 151. The outer sheath drive assembly 153 is connected to the proximal end of the outer sheath 14 and is used to drive the outer sheath 14 to move along the axial direction of the conveying device 100. The outer sheath drive assembly 153 includes an outer sheath button 1531 and an outer sheath sealing valve 1532. The outer sheath button 1531 is axially slidably connected to the housing of the fixed handle 151 and is used to drive the outer sheath 14 to move axially under the push of an external force. The outer sheath sealing valve 1532 allows the conveying sheath 12 to pass through and seals the circumference of the conveying sheath 12. The outer sheath drive assembly 153 may also be connected to a three-way valve (not shown in the figure). A conveying sheath drive assembly 154 is disposed within the movable handle 152. The conveying sheath drive assembly 154 is connected to the proximal end of the conveying sheath 12 and is used to drive the conveying sheath 12 to move along the axial direction of the conveying device 100. The delivery sheath drive assembly 154 includes a delivery sheath button 1541 and a delivery sheath sealing valve 1542. The delivery sheath button 1541 is axially slidably connected to the housing of the movable handle 152, and is used to drive the outer sheath 14 to move axially under the push of an external force. The delivery sheath sealing valve 1542 allows the sheath core 11 to pass through and seals the sheath core 11 circumferentially. The delivery sheath drive assembly 154 may also be connected to a three-way valve (not shown in the figure).
[0066] Therefore, the outer sheath drive assembly 153, under the push of an external force, can drive the outer sheath 14 to move distally or proximally, thereby achieving the retraction or release of the filter element 13. The delivery sheath drive assembly 154, under the push of an external force, can drive the delivery sheath 12 to move distally or proximally, thereby achieving the retraction and release of the branch support 200. The aforementioned external force refers to the thrust exerted by the operator on the outer sheath drive assembly 153 or the delivery sheath drive assembly 154.
[0067] After the filter element 13 is deployed, it should not be moved to avoid scratching the blood vessel. However, before deploying the branch stent 200, the positions of the sheath core 11 and the delivery sheath 12 still need to be adjusted so that the branch stent 200 is in the correct position after release, avoiding internal leakage. Therefore, the delivery handle 15 is configured with a relatively movable fixed handle 151 and a movable handle 152, which allows the branch stent 200 to move relative to the deployed filter 131 until the branch stent 200 reaches the correct position, after which the delivery sheath 12 is retracted to release the branch stent 200. For example, as Figure 5As shown, after the delivery device 100 completes the puncture of the aortic arch endovascular stent graft 300, the sheath core 11 and delivery sheath 12 need to be moved further distally to further dilate the puncture site on the aortic arch endovascular stent graft 300. Simultaneously, the proximal end of the unreleased branch stent 200 needs to be placed within the aortic arch endovascular stent graft 300 to prevent endoleak at the connection between the branch stent 200 and the aortic arch endovascular stent graft 300 after release. Therefore, the positions of the sheath core 11, delivery sheath 12, and unreleased branch stent 200 need to be adjusted by moving the movable handle 152.
[0068] In this embodiment, as Figure 5 and Figure 6 As shown, the conveying handle 15 also includes a connector 155, which is sleeved on the distal end of the movable handle 152. Figure 7 As shown, the distal end of the connector 155 is threadedly connected to the proximal end of the fixed handle 151, and the proximal end of the connector 155 is rotatably connected to the distal end of the movable handle 152. The proximal end of the fixed handle 151 is provided with an external thread 1511, and the distal end of the connector 155 is provided with an internal thread 1551 that meshes with the external thread 1511. The outer circumferential surface of the distal end of the movable handle 152 is provided with a groove 1521, and the proximal end of the connector 155 is provided with a latch 1552. The latch 1552 is movably disposed within the groove 1521, so that during the axial movement of the connector 155, the movable handle 152 can only move axially with the connector 155 and will not rotate circumferentially. When it is necessary to adjust the release position of the branch bracket 200, rotating the connector 155 causes the movable handle 152 to move along the axial direction of the conveying device 100. Specifically, the connector 155 improves the connection stability between the fixed handle 151 and the movable handle 152. In other embodiments, such as Figure 8 As shown, the conveying handle 15 may not include the connecting member 155. Moving the movable handle 152a axially relative to the fixed handle 151a allows movement of the conveying sheath 12a, the sheath core, and the undeployed branch support. Figure 8 (The sheath core and branch support are not labeled in the text).
[0069] Furthermore, a locking structure (not shown in the figure) is provided between the delivery sheath drive assembly 154 and the fixed handle 152. When the delivery sheath drive assembly 154 and the fixed handle 152 are locked, the delivery sheath drive assembly 154 can move with the fixed handle 152; when the delivery sheath drive assembly 154 and the fixed handle 152 are unlocked, the delivery sheath drive assembly 154 can move relative to the fixed handle 152. This embodiment is not limited to the specific structure of the locking structure; it can achieve locking of the delivery sheath drive assembly 154 and the fixed handle 152, and unlock the delivery sheath drive assembly 154 and the fixed handle 152 under external force (such as the pressure of a doctor).
[0070] In this embodiment, as Figure 9 As shown, the filter element 13 includes a filter screen 131 and a frame 132. The filter screen 131 has a proximal opening 1311 and a distal opening 1312. The distal opening 1312 communicates with the lumen of the outer sheath tube 14 through the proximal opening 1311. Figure 10 As shown, the frame 132 includes a traction wire 1321, a proximal support ring 1322, and a distal support ring 1323. The proximal support ring 1322 is connected to the proximal opening 1311 of the filter 131, and the distal support ring 1323 is connected to the distal opening 1312 of the filter 131. The traction wire 1321 is connected to the proximal support ring 1322, and the proximal end of the traction wire 1321 extends through the wall of the outer sheath tube 14 and is connected to the fixed handle 151. In this embodiment, the proximal end of the traction wire 1321 is fixedly connected to the housing of the fixed handle 151, so that when the outer sheath tube drive assembly 153 drives the outer sheath tube 14 to move towards the distal or proximal end, the filter 131 can maintain its position under the support of the traction wire 1321, thereby allowing the outer sheath tube 14 to retract or release the filter 131.
[0071] like Figure 10 As shown, the filter element 13 includes two traction wires 1321; the proximal support ring 1322 has a first opening 1324, and the two ends of the first opening 1324 are respectively connected to the two traction wires 1321.
[0072] The frame 132 also includes two connecting wires 1325; the proximal support ring 1322 has a second opening 1326, the two ends of which are respectively connected to the proximal ends of the two connecting wires 1325; the distal support ring 1323 has a third opening 1327, the two ends of which are respectively connected to the distal ends of the two connecting wires 1325.
[0073] In this embodiment, the two traction wires 1321, the proximal support ring 1322, the two connecting wires 1325, and the distal support ring 1323 are formed from a single metal wire through multiple bending processes. After bending the metal wire to form the distal support ring 1323 with the third opening 1327, the two ends of the distal support ring 1323 are bent to form the two connecting wires 1325. The two connecting wires 1325 are bent to form the proximal support ring 1322 with the first opening 1324 and the second opening 1326, wherein the proximal support ring 1322 is bent at the first opening 1324 to form the two traction wires 1321.
[0074] In this embodiment, the two traction wires 1321 are of different lengths, with the proximal end of the shorter traction wire 1321 fixedly connected to the longer traction wire 1321. This reduces the space occupied by the traction wire 1321 within the outer sheath tube 14 or reduces the aperture size required for the traction wire 1321 to pass through the wall of the outer sheath tube 14. Understandably, the shorter the traction wire 1321, the more advantageous it is to reduce the space occupied by the two traction wires 1321. Therefore, while meeting the shape and strength requirements for forming the proximal support ring 1322, the length of one of the traction wires 1321 can be shortened as much as possible.
[0075] Under the action of external force, the traction wire 1321 drives the filter element 1312 to move axially relative to the outer sheath tube 14. For example, when a doctor applies a pulling force to the traction wire 1321, the frame 132 deforms so that the filter element 1312 is completely contained within the outer sheath tube 14. In this embodiment, the frame 132 is formed by bending a single metal wire multiple times, which is simple in process and has high overall connection strength.
[0076] To achieve the pushing and retraction of the filter element 1312, the traction wire 1321 needs to have bending resistance, while the proximal support ring 1322, connecting wire 1325, and distal support ring 1323 need to be deformable. Specifically, the diameter of the traction wire 1321 is larger than the diameter of the metal wire segments forming the proximal support ring 1322, connecting wire 1325, and distal support ring 1323. In this embodiment, the frame 132 is entirely made of nickel-titanium wire, the diameter of the traction wire 1321 is 0.3 mm to 0.4 mm, and the diameter of the nickel-titanium wire segments forming the proximal support ring 1322, connecting wire 1325, and distal support ring 1323 is 0.08 mm to 0.1 mm. In other embodiments, the traction wire 1321 is made of stainless steel wire, and the proximal support ring 1322, connecting wire 1325, and distal support ring 1323 are made of nickel-titanium wire. Compared to tubular structures, the traction wire 1321 occupies less internal space in the outer sheath 14. Therefore, with the same diameter of the proximal opening 1311 of the filter 131, the outer sheath 14 required for the filter element 13 using the traction wire 1321 is smaller, thus making the delivery device 10 suitable for smaller blood vessels.
[0077] The filter element 13 unfolds and is supported within the branch vessel before in-situ fenestration and branch stent 200 deployment, intercepting emboli (air emboli, thrombi, etc.) generated by the perforation guidewire 20 during in-situ fenestration and by the delivery device 10 during branch stent 200 deployment. After unfolding, the distal support ring 1323 of the filter element 13 supports the vessel wall of the branch vessel, and the proximal support ring 1322 of the filter element 13 supports it within the outer sheath 14. Therefore, the outer sheath 14 is centrally located within the branch vessel after the filter element 13 unfolds. The delivery sheath 12, sheath core 11, and perforation guidewire 20, which pass through the outer sheath 14 and filter element 13, are all centrally located within the branch vessel, improving the accuracy of the perforation guidewire 20's puncture position on the aortic arch covered stent 300 and simultaneously improving the accuracy of the branch stent 200 deployment position.
[0078] In this embodiment, the guidewire body 21 includes a tube portion 211 and a protective sleeve 212, the protective sleeve 212 being disposed at the distal end of the tube portion 211. Figure 3 and Figure 11 The protective sleeve 212 has a closed state and an open state. When the protective sleeve 212 is in the open state, the protective sleeve 212 has a distal opening 2122, through which the membrane-breaking needle 22 can pass through the guide wire body 21.
[0079] The protective sleeve 212 is used to prevent the perforation needle 22 from damaging the blood vessel when passing through it. The perforation needle 22 only emerges from the guidewire body 21 when the perforation guidewire 20 reaches the preset position, thereby piercing the endovascular membrane on the aortic arch endovascular stent 300.
[0080] In this embodiment, the protective sleeve 212 is made of a soft material, such as biocompatible silicone or rubber. Figure 3 As shown, the distal end of the protective sleeve 212 is provided with a through hole 2121 that axially penetrates the protective sleeve 212, as... Figure 11 As shown, when the through hole is squeezed by the membrane-breaking needle 22, it expands into the distal opening 2122, that is, the protective sleeve 212 changes from a closed state to an open state.
[0081] When the protective sleeve 212 is in the closed state, its distal end face is arc-shaped to reduce resistance when passing through blood vessels.
[0082] like Figure 12 As shown, in other embodiments, in order to increase the flexibility of the membrane-breaking guide wire 20a, the tube body 211a may include at least one section of spring tube 2111a, with at least one end of the spring tube 2111a disposed near the distal end of the tube body 211a.
[0083] like Figure 13 and Figure 14 As shown, the conveying device 100 may further include a guide wire handle 30 detachably connected to the membrane-breaking guide wire 20. The guide wire handle 30 includes a handle body 31 and a locking cap 32. The proximal end of the membrane-breaking guide wire 20 is disposed inside the handle body 31. The locking cap 32 is sleeved on the distal end of the handle body 31 and, under the action of external force, clamps or releases the membrane-breaking guide wire 20 at the distal end of the handle body 31.
[0084] Specifically, the handle body 31 includes a clamping portion 311 and a first threaded portion 312, with the clamping portion 311 disposed at the distal end of the first threaded portion 312. The clamping portion 311 has a first inner cavity 313 through which the membrane-breaking guide wire 20 passes. The outer peripheral surface of the clamping portion 311 has a first conical surface 314, which gradually slopes towards the central axis from the proximal end to the distal end. The locking cap 32 includes a pressing portion 321 and a second threaded portion 322, and also has a second inner cavity 323 penetrating the pressing portion 321 and the second threaded portion 322. The clamping portion 311 and the first threaded portion 312 of the handle body 31 are disposed within the second inner cavity 323. The inner wall surface of the second inner cavity 323 has a second conical surface 324, which gradually slopes towards the central axis from the proximal end to the distal end. The second threaded portion 322 engages with the first threaded portion 312. When the locking cap 32 is screwed towards the proximal end, the second conical surface 324 gradually presses against the first conical surface 314, thereby clamping the membrane-breaking guide wire 20 with the clamping portion 311, achieving a fixed connection between the guide wire handle and the membrane-breaking guide wire 20. To loosen the guide wire handle, simply screw the locking cap 32 towards the distal end.
[0085] The guidewire handle 30 also includes a button 33, which is movably connected to the proximal end of the handle body 31. The button 33 is at least connected to the perforation needle 22 of the perforation guidewire 20 to drive the perforation needle 22 to move relative to the guidewire body 21. After the guidewire handle is fixed to the perforation guidewire 20, the perforation needle 22 is moved relative to the guidewire body 21 by operating the button 33, thereby causing the perforation needle 22 to pass through the distal end of the guidewire body 21 and pierce the membrane.
[0086] Specifically, see Figure 13 The guidewire body 21 includes a tubular portion 211, an elastic portion 212, and a connecting portion 213 connected in sequence. The perforating needle 22 passes through the tubular portion 211 and the elastic portion 212, and the proximal end of the perforating needle 22 is fixedly connected to the connecting portion 213. The connecting portion 213 is detachably connected to the button 33, which is used to squeeze the elastic portion 212 and cause the perforating needle 22 to extend from the distal end of the tubular portion 211. When the pressure applied to the button 33 is removed, the perforating needle 22 and the connecting portion 213 move proximally under the tension of the elastic portion 212, thereby retracting the perforating needle 22 into the guidewire body 21.
[0087] like Figure 15As shown, the button 33 includes a button body 331 and at least two deformable portions 332; the at least two deformable portions 332 are circumferentially disposed at the distal end of the button body 331, and the at least two deformable portions 332 enclose a cavity 333, the cavity 333 being used to accommodate the connecting portion 213 of the guide wire body 21; the outer peripheral surface of the deformable portion 332 is provided with a protrusion 3321, such as... Figure 13 As shown, the inner wall of the handle body 31 is provided with a groove 315. Figure 16 and 17 As shown, when the protrusion 3321 is directly opposite the groove 315, the cavity 333 is in an open state, and the connecting part 213 can enter the cavity 333. Figure 18 As shown, when the protrusion 3321 disengages from the groove 315, the deformable part 332 undergoes elastic deformation and converges inward along the radial direction of the button body 331, the cavity 333 is in a closed state, and the connecting part 213 is locked in the cavity 333.
[0088] When button 33 is in its natural state (i.e., not subjected to external pressure), such as Figure 15 As shown, the deformable portion 332 forms a certain angle with the axial direction of the button body 331, that is, the deformable portion 332 pops out radially. The four deformable portions 332 enclose to form the cavity 333. Figure 16 As shown, when the button 33 is placed inside the handle body 31 and the protrusion 3321 of the deformable part 332 is aligned with the groove 315 of the handle body 31, the deformable part 332 is still in its natural state or is squeezed inward to a certain extent, but the cavity 333 formed by the at least two deformable parts 332 can still allow the connecting part 213 of the guide wire body 21 to pass through. Moving the button 33 at this time allows the connecting part 213 of the guide wire body 21 to enter the cavity 333. Figure 17 As shown, until the resistance encountered when moving the button 33 increases, it indicates that the guide wire body 21 has been installed in place. Tightening the locking cap 32 secures the guide wire body 21 to the guide wire handle 30. Then, pressing the button 33 causes it to move distally under axial thrust. The deformable part 332 gradually disengages from the groove 315 and gradually presses inward, as... Figure 13 As shown, after the deformable part 332 completely disengages from the groove 315, the deformable part 332 moves inward under the pressure of the inner wall of the handle body 31, thereby clamping the connecting part 213 and realizing the fixed connection between the connecting part 213 and the button 33. At the same time, the button 33 presses the deformable part 332, causing the distal end of the rupture needle 22 to extend from the distal end of the guide wire body 21.
[0089] The operation process of the conveying device in this embodiment is as follows:
[0090] 1. After the aortic arch stent graft is deployed, the perforation guidewire is inserted along the distal end of one of the three branches of the aortic arch.
[0091] 2. The conveyor enters along the membrane breaking guide wire, and after reaching the preset position, the outer sheath is retracted to open the filter element.
[0092] 3. Install the guidewire handle onto the membrane rupture guidewire, adjust the position of the membrane rupture guidewire, and press the button to puncture the endovascular stent graft in the aortic arch, creating a puncture hole in the endovascular stent graft.
[0093] 4. Rotate the connector to move the sheath core, sheath tube and unreleased branch stent distally until the distal end of the unreleased branch stent enters the aortic arch endovascular stent graft, then withdraw the delivery sheath to release the branch stent.
[0094] 5. Push the outer sheath tube forward to retrieve the filter screen and remove the conveying device.
[0095] Example 2
[0096] The structure of the conveying device in Example 2 is largely the same as that of the conveying device in Example 1, the main difference being the structure of the membrane-breaking guide wire 20. In Example 2, as... Figure 18 and Figure 19 As shown, the membrane-breaking guidewire 20 includes a guidewire body 21 and a membrane-breaking needle 22 disposed within the guidewire body 21. The guidewire body 21 includes a tube portion 211 and a protective sleeve 212 connected to the distal end of the tube portion 211. The protective sleeve 212 includes two protective arms 2121 and two connecting arms 2122, the two protective arms 2121 being at least partially exposed outside the distal end of the tube portion 211.
[0097] The two protective arms 2121 are hinged together, and the space between the distal ends of the two protective arms 2121 is used to accommodate the distal end of the membrane-breaking needle 21. The proximal ends of the two protective arms 2121 are respectively hinged to the distal ends of the two connecting arms 2122, and the proximal ends of the two connecting arms 2122 are hinged to the membrane-breaking needle 21. When the membrane-breaking needle 21 moves to the distal end, the distal ends of the two protective arms 2121 move away from each other and expose the distal end of the membrane-breaking needle 21.
[0098] Specifically, such as Figure 19As shown, the two protective arms 2121 are hinged together by a first hinge rod 2123, the two ends of which are connected to the guide wire body 21. A through hole is provided on the first hinge rod 2123, through which the membrane-breaking needle 21 passes, allowing the membrane-breaking needle 21 to move axially relative to the protective arms 2121 and the first hinge rod 2123. The proximal end of the protective arm 2121 is hinged to the distal end of the connecting arm 2122 by a second hinge rod 2124. The proximal ends of the two connecting arms 2122 are hinged together by a third hinge rod 2125, which is fixedly connected to the membrane-breaking needle 22. Thus, when the membrane-breaking needle 22 moves distally, the connecting arm 2122 and the protective arm 2121 work together to move the protective arms 2121 away from each other.
[0099] Looking back Figure 18 The distal end of the tube body 211 is symmetrically provided with two U-shaped grooves 2112, the distal ends of which penetrate the tube body 211. The U-shaped grooves 2112 are used to avoid the protective arm 2121 and the connecting arm 2122, providing sufficient space for the opening of the protective sleeve 212.
[0100] The perforation needle 22 includes a support rod 221, a connecting rod 222, and a perforation head 223. The connecting rod 222 is connected to the proximal end of the perforation head 223, and the support rod 221 is connected to the proximal end of the connecting rod 222. The diameter of the support rod 221 is larger than the diameter of the connecting rod 222. The smaller-diameter connecting rod 222 is used to connect to the protective sleeve 212 to prevent the distal end of the perforation guidewire 20 from becoming too large. The larger-diameter support rod 221 provides sufficient support for the movement of the perforation needle 22. The perforation head 223 is approximately spindle-shaped, with a sharp and pointed distal end for easy puncture of the aortic arch endovascular stent graft 300.
[0101] To increase the flexibility of the membrane-breaking guide wire 20, the tube body 211 includes at least one section of spring tube 2111, with at least one end of the spring tube 2111 disposed near the distal end of the tube body 211.
[0102] Example 3
[0103] The main difference between Example 3 and Example 1 is that, as Figure 20 As shown, the filter element includes a first sub-filter element 133 and a second sub-filter element 134. The circumferential dimensions of both the first sub-filter element 133 and the second sub-filter element 134 gradually decrease from the distal end to the proximal end; the proximal end of the first sub-filter element 133 is disposed within the second sub-filter element 134, and the distal end of the first sub-filter element 133 extends beyond the distal end of the second sub-filter element 134.
[0104] The first sub-filter 133 has a first deformation region 1331, and the second sub-filter 134 has a second deformation region 1341. The projections of the first deformation region 1331 and the second deformation region 1341 on the cross-section of the filter 13 do not overlap. The cross-section is perpendicular to the central axis Z of the filter 13. In this embodiment, the first sub-filter 133 and the second sub-filter 134 have the same shape and size, but their circumferential orientations are different, thus ensuring that the projections of the first deformation region 1331 and the second deformation region 1341 on the cross-section of the filter 13 do not overlap.
[0105] The filter element 13 of the present invention provides dual protection for blood vessels by providing two independent and partially interlocking first sub-filter elements 133 and second sub-filter elements 134. Simultaneously, the first sub-filter elements 133 and second sub-filter elements 134 have first deformation regions 1331 and second deformation regions 1341 with different orientations. This allows the first sub-filter elements 133 and second sub-filter elements 134 to have different degrees of deformation or different deformation directions when subjected to the same radial pressure, thereby enabling the filter element 13 to better conform to blood vessels of various shapes.
[0106] The plate method can be used to test the changes in diameter of the first sub-filter 133 and the second sub-filter 134 under the same radial pressure, thereby testing the degree of deformation of the first sub-filter 133 and the second sub-filter 134. For example, see... Figure 21 With the first sub-filter 133 and the second sub-filter 134 in a freely unfolded state, parallel plates 01 and 02 are placed on opposite sides of the first sub-filter 133, and radial forces F of the same magnitude but opposite direction are applied perpendicularly to plates 01 and 02, respectively. The two parallel plates 01 and 02 remain parallel to each other throughout the test, i.e., they are always parallel to the central axis. Similarly, parallel plates 03 and 04 are placed on opposite sides of the second sub-filter 134, and radial forces F of the same magnitude but opposite direction are applied perpendicularly to plates 03 and 04, respectively.
[0107] If the diameter of the first sub-filter 133 clamped at the plate in its naturally unfolded state is R1, then the change in diameter of the first sub-filter 133 under the action of radial force F is the difference in diameter before and after radial compression, which can be represented by ΔR1, and the rate of change of diameter is ΔR1 / R1. To ensure that the plate itself does not deform during the application of radial force, so that the radial force can be applied uniformly throughout the plate, the thickness of the plate is at least 5mm. Similarly, if the diameter of the second sub-filter 134 clamped at the plate in its naturally unfolded state is R2, where R2 = R1, then the change in diameter of the second sub-filter 134 under the action of radial force F is the difference in diameter before and after radial compression, which can be represented by ΔR2, and the rate of change of diameter is ΔR2 / R2.
[0108] Based on the above test conditions, under the action of radial forces of the same magnitude and in the same radial direction, if ΔR1 / R1 is greater than ΔR2 / R2, or ΔR1 is greater than ΔR2, it indicates that the deformation of the first sub-filter 133 is greater under the force in that direction; otherwise, the deformation of the second sub-filter 134 is greater.
[0109] Specifically, the first sub-filter 133 must have a certain supporting force to resist the impact of blood flow. However, due to the deformation of the lesion area or the vascular segment near the lesion area, for example in... Figure 22 The blood vessel 3 in the middle has a non-circular cross-section, which causes the filter element with strong support to have poor adhesion to the vessel wall. Therefore, a first deformation zone 1331 is set so that the first sub-filter element 133 can deform to a certain extent under the pressure of the blood vessel wall, thereby better conforming to the blood vessel wall. See Figure 22 When the filter element 13 unfolds in the blood vessel 3, due to the presence of the first deformation zone 1331, the first sub-filter element 133 is more likely to elongate and deform along the X-axis. Similarly, due to the presence of the second deformation zone 1341, the second sub-filter element 134 is more likely to elongate and deform along the Y-axis. Therefore, for example in Figure 15 In this process, when the filter element 13 is subjected to a force from the blood vessel wall along the X-axis, the deformation of the first sub-filter element 133 and the second sub-filter element 134 is not the same. Even if the first sub-filter element 133 does not completely fit the blood vessel wall, the second sub-filter element 134, which is more likely to elongate and deform along the Y-axis, can fit the protruding part of the blood vessel wall and play a supplementary blocking role. That is, the filter element 13 can adaptively fit the blood vessel wall under the pressure of the blood vessel wall.
[0110] It should be noted that, in the first sub-filter 133, due to the presence of the first deformation zone 1331, the degree and direction of deformation of the first sub-filter 133 change with the relative position of the pressure applied to the first sub-filter 133 and the first deformation zone 1331. Similarly, due to the presence of the second deformation zone 1341, the degree and direction of deformation of the second sub-filter 134 change with the relative position of the pressure applied to the second sub-filter 134 and the second deformation zone 1341. Therefore, it is possible for the first sub-filter 133 and the second sub-filter 134 to have the same degree of deformation at a specific location. However, since the first deformation zone 1331 and the second deformation zone 1341 are oriented differently in the circumferential direction of the filter element 13, the deformation shapes of the first sub-filter element 133 and the second sub-filter element 134, i.e., the elongation and protrusion directions, are not exactly the same. That is, the projections of the first sub-filter element 133 and the second sub-filter element 134 on the cross-section of the filter element 13 do not completely overlap, but they can still adapt to the shape of the blood vessel, thereby improving the overall wall adhesion of the filter element 13.
[0111] like Figure 23 As shown, the perpendicular segment from the starting point of the first deformation zone 1331 to the central axis of the filter element 13 is the first line segment L1; the perpendicular segment from the starting point of the second deformation zone 1341 to the central axis of the filter element 13 is the second line segment L2; the angle α formed by the projections of the first line segment L1 and the second line segment L2 onto the cross-section is 80°-100°. When the angle α is less than 80°, the first deformation zone 1331 and the second deformation zone 1341 are too close. When the first sub-filter element 133 and the second sub-filter element 134 are subjected to radial pressure of the same radial direction and magnitude, the elongation and protrusion directions of the first sub-filter element 133 and the second sub-filter element are also too close, that is, the projections of the first sub-filter element 133 and the second sub-filter element onto the cross-section of the filter element 13 tend to overlap, thus failing to provide supplementary sealing. Similarly, when the included angle α is greater than 100°, and when the first sub-filter 133 and the second sub-filter 134 are subjected to radial pressure of the same magnitude and in the same radial direction, the elongation and protrusion directions of the first sub-filter 133 and the second sub-filter are also too close. Preferably, when the included angle α is 90°, the overlapping portion of the projections of the first sub-filter 133 and the second sub-filter 134 on the cross-section of the filter 13 is minimized, which is more conducive to improving the adhesion between the filter 13 and the blood vessel wall.
[0112] Since the first sub-filter 133 and the second sub-filter 134 are independently configured components, when the first sub-filter 133 and the second sub-filter 134 are compressed by the blood vessel wall, their distal openings can deform independently, thereby better conforming to the blood vessel wall. It should be noted that if the distance between the first sub-filter 133 and the second sub-filter 134 is too great, it will require too much blood vessel length, which is not conducive to the operation. Furthermore, the deformation shape of blood vessel segments with greater distance may differ, making it difficult for the first sub-filter 133 and the second sub-filter 134 to achieve secondary occlusion and thrombus interception. Therefore, in this embodiment, as... Figure 24 As shown, the length L3 of the portion of the first sub-filter 133 extending beyond the distal end of the second sub-filter 134 accounts for one-quarter to one-half of the overall length L4 of the first sub-filter 133. The circumferential dimensions of both the first sub-filter 133 and the second sub-filter 134 gradually decrease from the distal end to the proximal end; that is, the outer proximal end of the first sub-filter 133 provides a converging space for the second sub-filter 134. Even if the first sub-filter 133 and the second sub-filter 134 are partially fitted together, it does not affect the smooth convergence of the filter 13 by the outer sheath 14.
[0113] like Figure 25 As shown, the first sub-filter 133 includes a first filter screen 1333 and a first frame 1332; as Figure 26As shown, the first frame 1332 includes a first annular structure 13321 and a first support structure 13322. The first annular structure 13321 is disposed along the edge of the first filter screen 1333, and the first support structure 13322 extends from the first annular structure 13321 to the proximal end of the first sub-filter element 133. In this embodiment, the structure of the second sub-filter element 134 is the same as that of the first sub-filter element 133, that is, the second sub-filter element 134 includes a second filter screen 1343 and a second frame 1342; the second frame 1342 includes a second annular structure 13421 and a second support structure 13422. The second annular structure 13421 is disposed along the distal opening edge of the second filter screen 1343, and the second support structure 13422 extends from the second annular structure 13421 to the proximal end of the second sub-filter element 134. In other embodiments, the structure of the second sub-filter element 134 may be different from that of the first sub-filter element 133. The first frame 1332 and the second frame 1342 are made of materials with good biocompatibility and elasticity, such as nickel-titanium alloy and stainless steel. The first filter screen 1333 and the second filter screen 1343 are made of materials selected from metal woven mesh, polymer fiber woven or woven mesh, polymer mixed metal material woven or woven mesh, or porous polymer membrane, wherein the pore size of the filter screen is 0.1-0.5 mm.
[0114] In this embodiment, as Figure 26 As shown, the first annular structure 13321 has a first notch 13323, which forms the first deformation region 1331; the second annular structure 13421 has a second notch 13423, which forms the second deformation region 1313. In other embodiments, the first and second deformation regions may also be a wavy line segment, a line segment with a small outer diameter, or an elastic segment made of elastic material. The proportion of the first deformation region 1331 to the length of the first annular structure 13321 does not exceed 1 / 25, and the proportion of the second deformation region 1313 to the length of the second annular structure 13421 does not exceed 1 / 25. This is because excessively long first and second deformation regions would make it difficult for the support strength of the first sub-filter element 133 and the second sub-filter element 134 to meet the anchoring requirements.
[0115] Specifically, taking the first sub-filter 133 as an example, the first frame 1332 extends from the proximal end to the distal end of the first filter 1333, and finally coils around the edge of the distal opening of the first filter 1333 to form a first annular structure 13321 with a first notch 13323.
[0116] The first frame 1332 further includes a first proximal support ring 13324 and a traction wire 13325, wherein the first proximal support ring 13324 is disposed along the proximal opening edge of the first filter screen 1333; the second frame 1342 further includes a second proximal support ring 13424, wherein the second proximal support ring 13424 is disposed along the proximal opening edge of the second filter screen 1343; the distal end of the traction wire 13325 is sequentially connected to the first proximal support ring 13324 and the second proximal support ring 13424.
[0117] In this embodiment, the distal end of the traction wire 13325 passes through the outer sheath tube 14, and its proximal end passes through a hole in the wall of the outer sheath tube 14 to the outside of the outer sheath tube 14, thereby avoiding interference with the delivery sheath tube that needs to pass through the outer sheath tube 14. In other embodiments, the traction wire may be entirely passed through the outer sheath tube; or the outer sheath tube may be a double-lumen tube, with one lumen for passing through the traction wire, and the traction wire may be entirely passed through this lumen or partially passed through it.
[0118] The outer diameter of the traction wire 13325 ranges from 0.3mm to 0.35mm to meet the strength requirements for supporting the first sub-filter element 133 and the second sub-filter element 134. The wire diameter of the material used to make the first frame 1332 and the second frame 1342 ranges from 0.08mm to 0.1mm, thus minimizing the space occupied by the first proximal support ring 13324 within the outer sheath tube 14, allowing the outer sheath tube 14 with the same inner diameter to accommodate a larger delivery sheath tube.
[0119] like Figure 26 As shown, both the first proximal support ring 13324 and the second proximal support ring 13424 are open rings. One end of the first proximal support ring 13324 is connected to the first support structure 13322, and the other end is connected to the traction wire 13325. One end of the second proximal support ring 13424 is connected to the second support structure 13422, and the other end is connected to the traction wire 13325. When it is necessary to retract the first sub-filter 133 and the second sub-filter 134, pulling the traction wire 13325 causes the first proximal support ring 13324 and the second proximal support ring 13424 to deform under the pulling action of the traction wire 13325, facilitating the retraction of the first sub-filter 133 and the second sub-filter 134 into the outer sheath tube 14.
[0120] Furthermore, looking back Figure 25A connecting post 135 is provided between the first sub-filter element 133 and the second sub-filter element 134. The connecting post 135 is a hollow columnar structure. The distal opening of the connecting post 135 is connected to the proximal opening of the first filter screen 1333, and the proximal opening of the connecting post 135 is connected to the proximal opening of the second filter screen 1343. The connecting post 135 makes the connection between the first sub-filter element 133 and the second sub-filter element 134 more stable. The material of the connecting post 135 is selected from metal woven mesh, polymer fiber woven or woven mesh, polymer mixed metal material woven or woven mesh, or porous polymer membrane. The connecting post 135 is connected to the first sub-filter element 133 and the second sub-filter element 134 by welding, bonding, or other methods.
[0121] In some embodiments, one or more openings are provided on the connecting post, through which the plug captured by the second sub-filter can enter the first lumen of the outer sheath tube, thus preventing the second sub-filter from being blocked.
[0122] In other embodiments, such as Figure 27 and Figure 28As shown, the outer surface of the first filter 133a is provided with a groove 13331a that is recessed towards the inner side of the first filter 1333a. The groove 13331a extends spirally from the distal end to the proximal end of the first filter 1333a, and the first support structure 13322a is disposed within the groove 13331a. Since the first filter 1333a is relatively thin, the groove 1333a1 appears as a protrusion on the inner side of the first filter 1333a. This protrusion plays a guiding role within the first filter 1333a, causing the blood flow to form a vortex effect when flowing through the first filter 1333a, attracting thrombi into the bottom of the protective device, preventing escape or retention that obstructs blood flow through the micropores of the first filter 1333a; while plasma and healthy blood cells with structures smaller than the micropores of the first filter 1333a can flow towards the distal end through the micropores. Furthermore, the hollow pusher connected to the first sub-filter can be connected to a suction device or an extracorporeal circulation filtration device to promptly remove thrombi from the first sub-filter. Only the outer peripheral surface of the first sub-filter 133a has a groove 13331a; therefore, compared to a protective device without a groove 13331a, the gap between the outer peripheral surface of the first sub-filter 133a and the inner wall of the second sub-filter 134a is larger in this embodiment. When the distal opening of the first sub-filter 133a cannot conform to the blood vessel wall, some thrombi flow into the second sub-filter 134a from the sufficiently large gap between the outer peripheral surface of the first sub-filter 133a and the second sub-filter 134a, and are collected by the second sub-filter 134a. Conversely, when the distal opening of the first sub-filter 133 cannot fit the blood vessel wall, if the gap between the outer peripheral surface of the first sub-filter 133a and the second sub-filter 134a is too small, thrombi escaping from the first sub-filter 133a are prone to accumulate at the distal opening of the second sub-filter 134a, making it difficult for them to smoothly enter the second sub-filter 134a. During the removal of the protective device, these thrombi may fall back into the blood vessel, increasing the surgical risk.
[0123] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0124] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.
Claims
1. A conveying device for conveying a tubular support, characterized in that, include: Membrane rupture guidewire and delivery device; The delivery device includes an inner sheath, a delivery sheath, a filter element, and an outer sheath arranged from the inside out; there is a space between the outer peripheral surface of the sheath and the inner wall surface of the delivery sheath for accommodating the lumen support; the outer sheath and the filter element are movable relative to each other to release or retract the filter element; The membrane-perforating guidewire is movably disposed within the sheath core; the membrane-perforating guidewire includes a guidewire body and a membrane-perforating needle, the membrane-perforating needle is movably disposed within the guidewire body, and the membrane-perforating needle can extend beyond the distal end of the guidewire body to pierce the membrane on the membrane-covered stent under the action of external force.
2. The conveying device according to claim 1, characterized in that, The conveyor further includes a conveying handle, which includes a fixed handle and a movable handle; the movable handle is disposed near the fixed handle and is axially movable relative to the fixed handle; The proximal end of the outer sheath and the proximal end of the filter element are connected to the fixed handle, and the proximal end of the delivery sheath and the proximal end of the sheath core are connected to the movable handle.
3. The conveying device according to claim 2, characterized in that, The conveying handle also includes a connector, which is sleeved on the distal end of the movable handle; the distal end of the connector is threadedly connected to the proximal end of the fixed handle, and the proximal end of the connector is rotatably connected to the distal end of the movable handle.
4. The conveying device according to claim 2, characterized in that, The filter element includes a filter screen and a frame. The filter screen has a proximal opening and a distal opening, and the distal opening communicates with the lumen of the outer sheath through the proximal opening. The frame includes a traction wire, a proximal support ring, and a distal support ring. The proximal support ring is connected to the proximal opening of the filter screen, and the distal end of the traction wire is connected to the proximal support ring. The proximal end of the traction wire is connected to the fixed handle.
5. The conveying device according to claim 1, characterized in that, The guidewire body includes a tubular portion and a protective sleeve, wherein the protective sleeve is disposed at the distal end of the tubular portion; The protective sleeve has an open state and a closed state. When the protective sleeve is in the open state, the protective sleeve has a distal opening, through which the membrane-breaking needle can pass through the guidewire body.
6. The conveying device according to claim 5, characterized in that, The protective sleeve is made of a soft material and changes from a closed state to an open state when squeezed by the membrane-breaking needle.
7. The conveying device according to claim 5, characterized in that, The protective sleeve includes two protective arms and two connecting arms, and the two protective arms are at least partially exposed at the distal end of the tube body. The two protective arms are hinged together, and the space between the distal ends of the two protective arms is used to accommodate the distal end of the membrane-breaking needle. The proximal ends of the two protective arms are respectively hinged to the distal ends of the two connecting arms, and the proximal ends of the two connecting arms are hinged to the membrane-breaking needle. When the membrane-breaking needle moves to the distal end, the distal ends of the two protective arms move away from each other and expose the distal end of the membrane-breaking needle.
8. The conveying device according to claim 1, characterized in that, The conveying device also includes a guide wire handle detachably connected to the membrane breaking guide wire, the guide wire handle including a handle body and a locking cap; The proximal end of the membrane-breaking guidewire is disposed within the handle body; the locking cap is fitted onto the distal end of the handle body, and under the action of external force, the distal end of the handle body clamps or releases the membrane-breaking guidewire.
9. The conveying device according to claim 8, characterized in that, The guidewire handle also includes a button, which is movably connected to the proximal end of the handle body; The button is connected to at least the perforation needle of the perforation guidewire to drive the perforation needle to move relative to the guidewire body.
10. The conveying device according to claim 9, characterized in that, The guidewire body includes a tubular part, an elastic part, and a connecting part connected in sequence; the membrane-breaking needle passes through the tubular part and the elastic part, and the proximal end of the membrane-breaking needle is fixedly connected to the connecting part; The connecting part is detachably connected to the button, and the button is used to squeeze the elastic part and cause the rupture needle to extend from the distal end of the tube body.
11. The conveying device according to claim 10, characterized in that, The button includes a button body and at least two elastic parts; the at least two elastic parts are circumferentially disposed at the distal end of the button body, and the at least two elastic parts enclose a cavity for accommodating the connecting part of the guide wire body; The outer peripheral surface of the elastic part is provided with a protrusion, and the inner wall of the handle body is provided with a groove. When the protrusion is facing the groove, the cavity is in an open state, and the connecting part can enter the cavity. When the protrusion is disengaged from the groove, the elastic part undergoes elastic deformation and converges inward along the radial direction of the button body, the cavity is in a closed state, and the connecting part is locked in the cavity.
12. A conveying system, characterized in that, The system includes the conveying device according to any one of claims 1-11; the conveying system further includes a lumen support disposed between the sheath core and the conveying sheath.
Citation Information
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