Self-anchoring aortic branch superselection sheath and aortic branch superselection device

Abstract

The present invention provides a self-anchoring aortic branch superselection sheath and an aortic branch superselection device, which relate to the field of medical devices, including a sheath body and at least one group of sheath positioning structures arranged on the sheath body; a branch superselection side hole is arranged on the side wall of the distal region of the sheath body; each group of sheath positioning structures includes an anchor, which includes an end collar sleeved on the outside of the sheath body and axially limited to the outer wall of the sheath body, and at least two anchor arms evenly spaced along the circumference of the end collar, the first end of the anchor arm is connected to the end collar, and the second end of the anchor arm is suspended; the anchor arm is made of elastic material or an elastic member is connected between the anchor arm and the outer wall of the sheath body, so that the anchor arm is in an expanded state when it is freely released. The present invention has a simple structure, simple operation, can accurately adjust the angle of the catheter tip at the target position, and can superselect multiple branches after a single insertion.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a self-anchoring aortic branch superselection sheath and an aortic branch superselection device. Background Art

[0002] Intracavitary superselection and reconstruction is carried out under the guidance of medical imaging equipment, using interventional diagnostic sheaths (such as guide catheters, delivery sheaths, guide sheaths, etc.) to establish a channel between the diseased site in the patient's body and the external operating end, so as to introduce various diagnostic and therapeutic instruments, drugs, implantable devices, etc. to the patient's diseased site.

[0003] With the advancement of medical technology, endovascular repair has gradually become the main treatment for aortic aneurysms or aortic dissections involving visceral arteries due to its characteristics of less trauma, faster postoperative recovery and fewer complications. Endovascular repair uses intraluminal superselection and reconstruction, and uses a covered stent to isolate the aneurysm or dissection rupture to achieve the purpose of treatment. However, isolation will also block the blood supply of the branch arteries. Superselection and reconstruction of multiple branch arteries at the same time is a difficulty currently faced by vascular surgeons and interventional physicians.

[0004] In the prior art, imaging equipment is generally used to image the lesion site. Under the guidance of the imaging equipment, medical staff locate the opening of the branch blood vessel, introduce a sheath from the femoral artery or brachial artery to the aorta, and insert a guiding catheter with different head angles along the sheath, so that the catheter head is aligned with the branch opening angle, and a guide wire is inserted along the guiding catheter. The guide wire is selected into the branch blood vessel, the guiding catheter is withdrawn, the guide wire is retained, and a balloon or stent or other subsequent equipment is inserted along the guide wire.

[0005] However, the anatomical variation in the direction of the opening of the visceral artery is large. During the branch guidewire superselection process, it is often necessary to replace the guiding catheters with different head angles. Determining which angle of the guiding catheter should be used requires a high level of experience in medical equipment and medical staff.

[0006] In this regard, the prior art has developed an adjustable curved sheath tube, which can continuously adjust the angle of the catheter tip. However, the adjustable curved sheath tube has at least the following problems:

[0007] (1) Complex structure, difficult processing and high cost;

[0008] (2) Inaccurate positioning, complex operation, and long superselection time: The adjustable bend length of the adjustable sheath is fixed. If the adjustable bend length is too long, it may not be possible to adjust the expected angle. If the adjustable bend length is too short, during the superselection of the guidewire branch opening, the sheath is suspended in the blood vessel and may move or rotate, making it difficult to select the guidewire or the guidewire may fall out of the blood vessel after entering.

[0009] (3) The adjustable curved sheath can only superselect a single branch and cannot superselect multiple visceral branches at the same time. Summary of the invention

[0010] The purpose of the present application is to provide a self-anchoring aortic branch superselection sheath and an aortic branch superselection device. The present application has a simple structure, simple operation, can accurately adjust the angle of the catheter tip at the target position, and can superselect multiple branches after a single insertion.

[0011] To achieve the above objectives, this application adopts the following technical solutions:

[0012] In a first aspect, the present application provides a self-anchoring aortic branch superselective sheath, comprising a sheath body and at least one set of sheath positioning structures arranged on the sheath body.

[0013] Wherein: the sheath body has an inner cavity, the inner cavity includes a central lumen, and the side wall of the sheath body near the distal region is provided with a branch superselective side hole connected to the central lumen. Each group of the sheath positioning structures includes an anchor, the anchor includes an end ring and at least two anchor arms evenly spaced along the circumference of the end ring, the two ends of the anchor arm in the axial direction are respectively the first end of the anchor arm and the second end of the anchor arm, the first end of the anchor arm is fixed or integrally connected to the end ring, and the second end of the anchor arm is suspended; the end ring is sleeved on the outside of the sheath body and is axially limited to the outer wall of the sheath body; the second end of the anchor arm has a contracted state of radial contraction along the sheath body and an expanded state of radial expansion along the sheath body, the anchor arm is made of elastic material or an elastic member is connected between the anchor arm and the outer wall of the sheath body, so that the anchor arm is in the expanded state when it is freely released.

[0014] After the self-anchoring aortic branch superselection sheath provided by the present application is lowered into the aorta along the guide wire, with the proximal bend of the guide wire supported on the aortic intima and at least two anchoring arms evenly spaced circumferentially arranged along the end ring supported on the aortic intima, the sheath body will not be offset due to the insertion of the branch guide wire. The sheath has a simple structure, simple operation, can accurately adjust the angle of the catheter tip at the target position, reduce the difficulty of branch superselection, and can superselect multiple branches after a single insertion, thereby improving the efficiency of the operation.

[0015] The specific usage can be obtained by referring to the description of the specific embodiments part of this application specification.

[0016] In the technical solution of the present application, optionally, the sheath positioning structure includes two groups, one group of anchors of the sheath positioning structure is arranged on the distal side of the branch superselection side hole, and the other group of anchors of the sheath positioning structure is arranged on the proximal side of the branch superselection side hole; the second end of the anchor arm is in a contracted state, the second end of the anchor arm of the anchor located on the proximal side of the branch superselection side hole is on the proximal side of the end ring, and the second end of the anchor arm of the anchor located on the distal side of the branch superselection side hole is on the distal side of the end ring.

[0017] In the technical solution of the present application, optionally, in the anchoring member: each of the anchoring arms is a U-shaped coil with a closed second end and two free ends of the first end fixed or integrally connected to the end ring; and / or the end of the second end of each of the anchoring arms is provided with a flange folded radially outward along the sheath body in a contracted state.

[0018] In the technical solution of the present application, optionally, each group of the sheath positioning structure further includes a retractable assembly corresponding to the anchor, and the retractable assembly includes a retractable tube and a hard push-pull wire. The retractable tube is sleeved on the outside of the sheath body, the hard push-pull wire passes through the inner cavity of the sheath body, and the distal end of the hard push-pull wire is fixedly connected to the retractable tube; the hard push-pull wire can push and pull the retractable tube along the axial direction of the sheath body, so that the retractable tube can slide from the first end of the anchor arm to the second end of the anchor arm, thereby radially retracting the second end of the anchor arm along the sheath body, and can slide from the second end of the anchor arm to the first end of the anchor arm, thereby releasing the second end of the anchor arm.

[0019] Further optionally, in each group of the sheath positioning structure, the second end of the anchoring arm is in a contracted state, the end of the retractable tube close to the first end of the anchoring arm is the first end of the retractable tube, and the end of the retractable tube close to the second end of the anchoring arm is the second end of the retractable tube: an axial limiting portion of the retractable tube is also provided on the outer wall of the sheath body to block at least part of the retractable tube along the axial direction of the sheath body at the side of the second end of the anchoring arm toward the end ring.

[0020] Further optionally, the anchoring members are respectively sleeved in circumferential grooves provided on the outer circumferential surface of the sheath tube body, and the parts of the sheath tube body located on both sides of each of the circumferential grooves are respectively the first side tube and the second side tube: the retractable tube is sleeved on the outside of one of the first side tube and the second side tube facing the first end of the retractable tube, and the outer diameter of one of the first side tube and the second side tube facing the second end of the retractable tube is larger than the outer diameter of the second end of the retractable tube.

[0021] In the technical solution of the present application, optionally, the distal end of the sheath body is connected to a guide head with a tapered outer peripheral surface at the distal end, and a guide wire through hole is provided inside the guide head; the guide wire through hole is an eccentric hole whose distal end is concentric with the central lumen and gradually becomes eccentric with the central lumen toward the proximal direction; the inner cavity of the sheath body also includes a guide wire cavity, and the distal end of the guide wire cavity is connected to the proximal end of the guide wire through hole. And / or, a guide component is also fixed or integrally connected inside the sheath body, the guide component is located on the distal side of the branch superselection side hole and radially closes the central lumen along the sheath body, and the proximal surface of the guide component is a guide surface inclined in the direction of the branch superselection side hole.

[0022] In a second aspect, the present application provides an aortic branch superselection device, comprising an operating handle and the aforementioned groups of sheath positioning structures, each of which further comprises a retractable and deployable assembly corresponding to the anchoring member, as described in the embodiment of the self-anchoring aortic branch superselection sheath.

[0023] The operating handle includes a main handle, a driving member and a transmission member. Specifically, the proximal end of the sheath body is fixedly connected to the distal end of the main handle. The main handle has a main handle inner cavity connected to the inner cavity of the sheath body. The proximal end of the main handle is provided with a lower instrument entrance connected to the inner cavity of the main handle. The driving member is movably mounted on the main handle, the transmission member is axially slidably mounted in the inner cavity of the main handle and is transmission-connected to the driving member. The proximal end of the hard push-pull wire penetrates into the inner cavity of the main handle and is connected to the transmission member. The driving member can drive the transmission member to push and pull the hard push-pull wire along the axial direction of the sheath body.

[0024] Since the aortic branch superselection device provided in the present application includes the self-anchoring aortic branch superselection sheath provided in the first aspect, the aortic branch superselection device provided in the present application can achieve all the beneficial effects that the self-anchoring aortic branch superselection sheath provided in the first aspect can achieve.

[0025] In the technical solution of the aortic branch superselection device, optionally, the operating handle also includes a proximal handle and a proximal sealing rubber pad. The lower instrument entrance of the main handle is arranged on the proximal end face of the main handle, and the distal end of the proximal handle is threadedly sleeved with the proximal end of the main handle. The proximal inner surface of the inner cavity of the main handle is an inclined surface with a diameter gradually decreasing from the proximal end to the distal end. The proximal sealing rubber pad is arranged in the inner cavity of the main handle, and the distal outer surface of the proximal sealing rubber pad is in contact with the inclined surface; at least one instrument channel axially passing through the proximal sealant is provided on the proximal sealant. While the proximal handle rotates relative to the main handle, it squeezes the proximal sealant axially toward the distal direction or releases it toward the proximal direction, so that the instrument channel is radially compressed or radially expanded.

[0026] Further optionally, the operating handle further comprises a dust sleeve. The proximal handle comprises a proximal cylindrical section and a distal cylindrical section integrally connected in the axial direction, the distal cylindrical section is inserted into and threadedly connected to the proximal interior of the main handle, and a lap joint protrusion extending in the circumferential direction of the proximal cylindrical section is provided on the distal surface of the proximal cylindrical section; the dust sleeve is sleeved outside the lap joint protrusion, and the proximal end of the dust sleeve is threadedly connected to the lap joint protrusion, and the distal inner surface of the dust sleeve contacts the proximal outer surface of the main handle and can slide along the axial direction of the main handle.

[0027] In the technical solution of the aortic branch superselection device, optionally, a push-pull wire channel is provided in the inner cavity of the main handle, a distal sealing rubber sleeve is provided inside the push-pull wire channel, the push-pull wire passes through the distal sealing rubber sleeve and the push-pull wire channel, and the push-pull wire is interference fit with the distal sealing rubber sleeve.

[0028] In particular, in the present application, the “and / or” mentioned here respectively indicates that the first feature before the “and / or” and the second feature after the “and / or” include the following specific configuration methods: (1) only the first feature is set without the second feature; (2) only the second feature is set without the first feature; (3) the first feature and the second feature are set at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0030] Figure 1 A perspective view of the overall structure of the aortic branch superselection device provided by an embodiment of the present invention;

[0031] Figure 2 A partial structural perspective view of a self-anchoring aortic branch superselection sheath in the aortic branch superselection device provided in an embodiment of the present invention;

[0032] Figure 3 for Figure 2 A schematic diagram of the appearance of the structure shown;

[0033] Figure 4 for Figure 3 An exploded schematic diagram of the assembly relationship of the sheath body, the anchoring member and the retractable assembly in the structure shown;

[0034] Figure 5 for Figure 3 A schematic diagram of the structure of an anchor member;

[0035] Figure 6 for Figure 2 FF line cross-section of the middle sheath tube body;

[0036] Figure 7 for Figure 2 , a cross-sectional view of the guide member;

[0037] Figure 8 A partial structural perspective view of an operating handle in the aortic branch superselection device provided in an embodiment of the present invention;

[0038] Fig. 9 A schematic diagram of the use of the self-anchoring aortic branch superselective sheath provided in an embodiment of the present invention;

[0039] Fig.10 for Fig. 9 A magnified view of the local structure of the middle A area;

[0040] Fig.11 for Fig. 9 A magnified view of the local structure of the middle B area;

[0041] Fig.12 for Fig. 9 A magnified view of the local structure of the middle C area;

[0042] Fig.13 for Fig. 9 A magnified view of the local structure of area D in the middle.

[0043] Icons: 100-sheath body; 101-first side tube; 102-second side tube; 103-large diameter tube section; 11-central tube cavity; 111-branch superselection side hole; 12-push-pull wire cavity; 13-guide wire cavity; 14-circumferential groove; 15-guide head; 151-guide wire through hole; 16-guide component; 161-guide surface; 2-anchoring member; 21-end collar; 22-anchoring arm; 221-first end of anchoring arm; 222-second end of anchoring arm; 2221-flanging; 3-retracting assembly; 31-retracting tube; 311-first end of retracting tube; 312-second end of retracting tube; 32-hard push-pull wire; 41-first developing ring; 42-second developing ring; 43-third developing ring;

[0044] 200-operating handle; 5-main handle; 501-inner cavity of main handle; 502-push-pull wire channel; 503-external flange; 51-driving member; 52-transmission member; 6-proximal handle; 61-proximal cylindrical section; 611-overlapping protrusion; 62-distal cylindrical section; 7-proximal sealing rubber pad; 71-instrument channel; 8-dustproof sleeve; 801-inner boss; 9-distal sealing rubber sleeve;

[0045] 300 - guide wire; 400 - branch guide wire. DETAILED DESCRIPTION

[0046] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0047] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0048] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0049] In the description of the present invention, it should be noted that:

[0050] Unless otherwise clearly specified and limited, the terms "disposed", "installed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0051] The orientation or position relationship indicated by the terms "proximal", "distal", "front end", "rear end", "axial", "radial", "inner", "outer", etc. is based on the orientation or position relationship shown in the drawings, or is the orientation or position relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0052] The terms “first”, “second”, etc. are only used for distinguishing descriptions and do not indicate the total number or relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0053] In the following, the end of the medical device close to the operator during surgery is the proximal end of the medical device, the end of the medical device entering the patient's blood vessel is the distal end of the medical device, the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end; some embodiments of the present invention are described in detail in conjunction with the accompanying drawings. In the absence of conflict, the features of the following embodiments and the optional embodiments in the embodiments can be combined with each other.

[0054] The first aspect of the present application provides a self-anchoring aortic branch superselective sheath, referring to Figures 2 to 6 The self-anchoring aortic branch superselective sheath comprises a sheath body 100 and at least one group of sheath positioning structures arranged on the sheath body 100; the sheath body 100 has an inner cavity, the inner cavity comprises a central lumen 11, and a branch superselective side hole 111 connected to the central lumen 11 is arranged on the side wall of the sheath body 100 near the distal end; each group of sheath positioning structures comprises an anchor 2, the anchor 2 comprises an end collar 21 and at least two anchor arms 22 evenly spaced along the circumference of the end collar 21, with the two ends of the anchor arm 22 in the axial direction being the first end 221 of the anchor arm, respectively. And the second end 222 of the anchoring arm, the first end 221 of the anchoring arm is fixed or integrally connected to the end ring 21, and the second end 222 of the anchoring arm is suspended; the end ring 21 is sleeved on the outside of the sheath body 100 and is axially limited to the outer wall of the sheath body 100; the second end 222 of the anchoring arm has a contracted state radially contracted along the sheath body 100 and an expanded state radially expanded along the sheath body 100, the anchoring arm 22 is made of elastic material or an elastic member is connected between the anchoring arm 22 and the outer wall of the sheath body 100, so that the anchoring arm 22 is in an expanded state when it is freely released.

[0055] There are multiple optional types of state switching methods for the second end 222 of the anchoring arm in the present application, such as but not limited to, in the first type of switching method, when in use, the self-anchoring aortic branch superselective sheath provided by the present application is used in conjunction with the outer sheath, that is, the sheath body 100 is passed through the outer sheath, and the outer sheath is pushed and pulled relative to the sheath body 100, so that the second end 222 of the anchoring arm can be accommodated in or released from the outer sheath, so that the second end 222 of the anchoring arm can be radially contracted or radially expanded; in the second type of switching method, the sheath body 100 in the present application is also provided with a structure that can radially retract or release the second end 222 of the anchoring arm, and the second end 222 of the anchoring arm can be radially contracted or radially expanded by this structure.

[0056] The Self-Anchoring Aortic Branch Superselective Sheath is used as follows:

[0057] Reference Figures 9 to 13 , combined with Figures 2 to 6First, under percutaneous puncture, a guide wire 300 is inserted into the aorta to the lesion position, and the proximal end of the guide wire 300 is bent and supported on the aortic intima; then, the sheath body 100 of the self-anchored aortic branch superselective sheath provided by the present application is inserted along the guide wire 300. During the insertion process, the second end 222 of the anchoring arm is in a radially contracted state. By pushing, pulling and rotating the sheath body 100 along the guide wire 300, the branch superselective side hole 111 is aligned with the target branch blood vessel opening. Then, the second end 222 of the anchoring arm is in a radially expanded state. Since the anchor 2 includes an end ring 21 and at least two circumferentially evenly spaced portions arranged along the end ring 21, Anchoring arms 22, thus, the anchor 2 can be supported on the aortic intima by the ends of at least two second ends 222 of the anchoring arms and can be positioned more stably inside the aorta; thereafter, the branch guidewire 400 is inserted along the central lumen 11 of the sheath body 100, and the branch guidewire 400 is introduced into the target branch blood vessel through the branch superselective side hole 111 of the sheath body 100. During the process, under the common positioning of the proximal bend of the guide guidewire 300 supported on the aortic intima, and at least two anchoring arms 22 evenly spaced circumferentially arranged along the end ring 21 supported on the aortic intima, the sheath body 100 will not be offset due to the insertion of the branch guidewire 400. When it is necessary to introduce a branch guidewire 400 into multiple target branch vessels, after completing the introduction of the branch guidewire 400 into one target branch vessel and implanting the branch stent along the branch guidewire 400 through the central lumen 11 of the sheath body 100, the branch guidewire 400 can be withdrawn to restore the second end 222 of the anchoring arm to a radially contracted state, and the sheath body 100 can be rotated and pushed and pulled again to redetermine the position and angle of the sheath body 100 and repeat the above operation; after the operation is completed, the second end 222 of the anchoring arm can be restored to a radially contracted state and the self-anchoring aortic branch superselective sheath can be withdrawn from the body.

[0058] After the self-anchored aortic branch superselective sheath provided by the present application is lowered into the aorta along the guide wire 300, Fig.10 The proximal bend of the guide wire 300 shown is supported on the aortic intima, and Fig.11 and Fig.13 As shown, at least two anchoring arms 22 evenly spaced circumferentially along the end ring 21 are supported under the common positioning of the aortic intima, and the sheath body 100 will not be offset due to the insertion of the branch guide wire 400. It has a simple structure, simple operation, can accurately adjust the angle of the catheter tip at the target position, reduce the difficulty of branch superselection, and superselect multiple branches after a single insertion, thereby improving the efficiency of the operation.

[0059] In order to further enhance the support stability of the sheath body 100 on the aortic intima, in an optional embodiment of the present application, two groups of sheath positioning structures are provided, and the anchor 2 of one group of sheath positioning structures is provided on the distal side of the branch superselected side hole 111, and the anchor 2 of the other group of sheath positioning structures is provided on the proximal side of the branch superselected side hole 111; the second end 222 of the anchor arm is in a contracted state, the second end 222 of the anchor arm of the anchor 2 located on the proximal side of the branch superselected side hole 111 is on the proximal side of the end collar 21, and the second end 222 of the anchor arm of the anchor 2 located on the distal side of the branch superselected side hole 111 is on the distal side of the end collar 21. When the second end 222 of the anchor arm of the anchor 2 in the two groups of sheath positioning structures is in an expanded state, the support effect is as follows: Fig. 9 , Fig.11 and Fig.13 As shown, in addition, with respect to the number of anchoring arms 22 of each anchoring member 2, in the present application, the number of the anchoring arms 22 is set to be at least two evenly spaced along the circumference of the end collar 21, but it should be understood that the number of the anchoring arms 22 is set to be more than two, such as three, four, five or more, which can also enhance the support stability of the sheath body 100 in the aortic vessel to a certain extent.

[0060] In an optional embodiment of the present application, Figure 4 and Figure 5 As shown, in each anchoring member 2: each anchoring arm 22 is respectively a U-shaped coil, the second end of the U-shaped coil is closed as the second end 222 of the anchoring arm, and the two free ends of the first end are fixed or integrally connected to the end collar 21 as the first end 221 of the anchoring arm. In addition, in order to reduce the pressure of the second end 222 of the anchoring arm pressed against the aortic intima in the expanded state, so as to reduce the damage to the aortic intima, in an optional embodiment of the present application, the end of the second end 222 of each anchoring arm in each anchoring member 2 is provided with a flange 2221 which is folded radially outward along the sheath body 100 in the contracted state, and in the expanded state, the setting of the flange 2221 can increase the contact area of ​​the end of the second end 222 of each anchoring arm and thus reduce the pressure.

[0061] In addition, in the optional embodiments of the present application, refer to Figures 2 to 4 as well as Figure 6 The distal end of the sheath body 100 is connected to a guide head 15 having a tapered outer peripheral surface at the distal end, and a guide wire through hole 151 is provided inside the guide head 15; Figure 6 As shown, combined Figure 2The guidewire through hole 151 is an eccentric hole whose distal end is concentric with the central lumen 11 and gradually becomes eccentric with the central lumen 11 toward the proximal direction; the inner cavity of the sheath tube body 100 also includes a guidewire cavity 13, and the distal end of the guidewire cavity 13 is connected to the proximal end of the guidewire through hole 151. In this optional embodiment, by providing a guide head 15 for guidance, the sheath body 100 can be smoothly introduced into the lesion location, and a guidewire cavity 13 is provided inside the sheath body 100, and an eccentric guidewire through hole 151 is provided inside the guide head 15 to communicate with the guidewire cavity 13, so that the guide guidewire 300 can pass through the sheath body 100 along the guidewire cavity 13 and the guidewire through hole 151, and the central lumen 11 of the sheath body 100 is reserved for the branch guidewire 400 to pass through, thereby avoiding interference and entanglement between the guide guidewire 300 when the branch guidewire 400 is inserted and other instruments (balloon catheter, etc.) are inserted along the branch guidewire 400 through the central lumen 11 of the sheath body 100, thereby further improving the surgical efficiency.

[0062] In addition, in order to further improve the superselection smoothness of the branch guide wire 400, in an optional embodiment of the present application, refer to Figure 7 , combined with Figure 2 A guide component 16 is also fixed or integrally connected inside the sheath body 100. The guide component 16 is located on the distal side of the branch superselection side hole 111 and radially closes the central lumen 11 along the sheath body 100. The proximal surface of the guide component 16 is a guide surface 161 inclined toward the branch superselection side hole 111, so as to guide the distal end of the branch guide wire 400 during superselection, so that the branch guide wire 400 can smoothly enter the target branch blood vessel.

[0063] In addition, although it is mentioned in the above introduction that there are multiple optional types of state switching methods for the second end 222 of the anchoring arm in the present application, for the first type of switching method listed above (when in use, the self-anchoring aortic branch superselective sheath provided by the present application needs to be used in conjunction with the outer sheath, that is, the sheath body 100 is passed through the outer sheath, and the outer sheath is pushed and pulled relative to the sheath body 100, so that the second end 222 of the anchoring arm can be accommodated in or released from the outer sheath, so that the second end 222 of the anchoring arm can be radially contracted or radially expanded), and the second type of switching method (a structure that can radially retract or release the second end 222 of the anchoring arm is also provided on the sheath body 100, and the second end 222 of the anchoring arm can be radially contracted or radially expanded by this structure), it is obvious that the second type of switching method is easier to operate.

[0064] On this basis, refer to Figures 2 to 4In an optional embodiment of the present application, each group of sheath positioning structures also includes a retractable assembly 3 corresponding to the anchor 2, and the retractable assembly 3 includes a retractable tube 31 and a hard push-pull wire 32. The hard push-pull wire 32 can be made of, but not limited to, stainless steel wire, titanium alloy wire or other metal wire; the retractable tube 31 is sleeved on the outside of the sheath body 100, and the hard push-pull wire 32 passes through the inner cavity of the sheath body 100, and the distal end of the hard push-pull wire 32 is fixedly connected to the retractable tube 31, wherein, optionally, the inner cavity of the sheath body 100 also includes a push-pull wire cavity 12 corresponding to the hard push-pull wire 32 one by one, so as to avoid interference with the guide wire 300, the branch guide wire 400 and other instruments. The hard push-pull wire 32 can push and pull the retractable tube 31 axially along the sheath body 100, so that the retractable tube 31 can slide from the first end 221 of the anchoring arm to the second end 222 of the anchoring arm, thereby radially retracting the second end 222 of the anchoring arm along the sheath body 100, and can slide from the second end 222 of the anchoring arm to the first end 221 of the anchoring arm, thereby releasing the second end 222 of the anchoring arm. In this optional embodiment, the retractable assembly 3 is used as a structure capable of radially retracting or releasing the second end 222 of the anchoring arm, which is more convenient to operate than using an additional outer sheath, and in the process of being lowered into the aorta, the overall diameter of the device is smaller, which is conducive to the rapid passage of the device.

[0065] In this optional embodiment, further optionally, as Figure 4 As shown, in each set of sheath positioning structures, the anchor arm second end 222 is in a contracted state, the end of the retractable tube 31 close to the anchor arm first end 221 is the retractable tube first end 311, and the end of the retractable tube 31 close to the anchor arm second end 222 is the retractable tube second end 312: an axial limiter for the retractable tube is also provided on the outer wall of the sheath body 100 to block at least part of the retractable tube 31 along the axial direction of the sheath body 100 at the side of the anchor arm second end 222 facing the end collar 21. Thus, the axial limiter for the retractable tube can be used to prevent the retractable tube 31 from detaching from the anchor arm second end 222 when sliding from the anchor arm first end 221 toward the anchor arm second end 222, so that the retractable tube 31 cannot retreat and radially retract the anchor arm second end 222 again. Those skilled in the art should understand that the present application does not limit the requirement of setting up such an axial limit portion for the retractable tube. In some optional embodiments of the present application, the axial limit portion for the retractable tube may not be provided, and the operator can control the force of pushing and pulling the hard push-pull wire 32 to prevent the retractable tube 31 from slipping off the second end 222 of the anchoring arm. However, this places higher requirements on the operator's surgical operation. Therefore, it is preferred to set up such an axial limit portion for the retractable tube in the present application.

[0066] Continue to refer to Figure 4When the above-mentioned axial limiting portion of the retractable tube is provided, further optionally, the anchoring members 2 are sleeved one by one in the circumferential grooves 14 provided on the outer circumferential surface of the sheath tube body 100, and the parts of the sheath tube body 100 located on both sides of each circumferential groove 14 are the first side tube 101 and the second side tube 102 respectively: the retractable tube 31 is sleeved on the outside of one of the first side tube 101 and the second side tube 102 facing the first end 311 of the retractable tube, and the outer diameter of one of the first side tube 101 and the second side tube 102 facing the second end 312 of the retractable tube is larger than the outer diameter of the second end 312 of the retractable tube; shown in Figure 4 That is, the retractable tube 31 is sleeved on the outside of the second side tube 102, and the outer diameter of the first side tube 101 is larger than the outer diameter of the second end 312 of the retractable tube, so that the shoulder end face formed between the first side tube 101 and the circumferential groove 14 is used as the axial limit portion of the retractable tube to block the end face of the second end 312 of the retractable tube, so as to prevent the retractable tube 31 from slipping off the second end 222 of the anchoring arm. In this optional embodiment, when two sets of sheath tube positioning structures are provided, a large-diameter tube section 103 with an outer diameter larger than the first end 311 of the retractable tube can also be provided at the middle of the two circumferential grooves 14 on the sheath tube body 100, and the shoulder end face formed between the large-diameter tube section 103 and the second side tube 102 blocks the end face of the first end 311 of the retractable tube, and the branch superselection side hole 111 is provided on the large-diameter tube section 103.

[0067] To further improve the positioning accuracy, in the present application, at least one of the three parts, the part corresponding to the end ring 21 in each anchor 2 and the part corresponding to the proximal end of the guide head 15, on the outside of the sheath body 100 is also provided with a developing mark to assist the operator in positioning, for example, Figure 2 As shown, when two groups of sheath positioning structures are set, a first developing ring 41 is sleeved on the outside of the sheath body 100 at a position corresponding to the end ring 21 in one group of sheath positioning structures, a second developing ring 42 is sleeved on the outside of the sheath body 100 at a position corresponding to the end ring 21 in the other group of sheath positioning structures, and a third developing ring 43 is sleeved on the outside of the sheath body 100 at a position corresponding to the proximal end of the guide head 15. Each developing ring is preferably but not limited to being made of non-radiopaque materials such as platinum, iridium, tantalum, gold, stainless steel, platinum-iridium alloy, etc.

[0068] Based on the second state switching mode of the second end 222 of the anchoring arm in the present application, each group of sheath positioning structures also includes a retractable assembly 3 corresponding to the anchor 2, and the retractable assembly 3 includes an optional embodiment structure of a retractable tube 31 and a hard push-pull wire 32. The second aspect of the present application also provides an aortic branch superselection device, referring to Figure 1 and Figure 8 The aortic branch superselection device includes an operating handle 200 and the aforementioned self-anchoring aortic branch superselection sheath.

[0069] Specifically, Figure 1 and Figure 8 As shown, the operating handle 200 includes a main handle 5, a driving member 51 and a transmission member 52; the proximal end of the sheath body 100 is fixedly connected to the distal end of the main handle 5, the main handle 5 has a main handle inner cavity 501 connected to the inner cavity of the sheath body 100, and the proximal end of the main handle 5 is provided with an instrument lower entrance connected to the main handle inner cavity 501; the driving member 51 is movably installed on the main handle 5, the transmission member 52 is axially slidably installed in the main handle inner cavity 501 and is transmission-connected to the driving member 51, the proximal end of the hard push-pull wire 32 penetrates into the main handle inner cavity 501 and is connected to the transmission member 52, and the driving member 51 can drive the transmission member 52 to push and pull the hard push-pull wire 32 along the axial direction of the sheath body 100.

[0070] Among them, the driving member 51 and the transmission member 52 have a variety of optional combination structures, for example but not limited to, the driving member 51 adopts a knob sleeved on the end of the main handle 5, the inner circumference of the knob is provided with an internal thread, and the transmission member 52 adopts a screw connected to the proximal end of the hard push-pull wire 32, the screw is axially slidably connected to the inner cavity 501 of the main handle and is threadedly connected to the knob, and the knob is rotated relative to the main handle 5, and the screw can slide back and forth along the main handle 5, so as to push and pull the hard push-pull wire 32; or, Figure 8 As shown, a side hole connected to the main handle inner cavity 501 is provided on the side wall of the main handle 5, and a rotating shaft is provided in the side hole. The driving member 51 adopts a ratchet gear installed on the rotating shaft, and the transmission member 52 adopts a ratchet bar axially slidably connected to the side wall of the main handle inner cavity 501 and extending axially along the main handle 5. The ratchet bar is connected to the proximal end of the hard push-pull wire 32, and the ratchet gear is rotated back and forth to slide the ratchet bar along the main handle 5 back and forth, so as to push and pull the hard push-pull wire 32. For the convenience of installation, the ratchet bar can be provided on the side wall of the sleeve, and the sleeve is slidably connected to the side wall of the main handle inner cavity 501.

[0071] When two groups of retractable and retractable components 3 are provided, two groups of driving members 51 and transmission members 52 may be provided correspondingly to control two hard push-pull wires 32 respectively.

[0072] Continue to refer to Figure 8In an optional embodiment of the aortic branch superselection device provided in the present application, the operating handle 200 also includes a proximal handle 6 and a proximal sealing rubber pad 7 (optionally but not limited to being made of silicone); the lower instrument entrance of the main handle 5 is arranged on the proximal end face of the main handle 5, and the distal end of the proximal handle 6 is sleeved with the proximal thread of the main handle 5; the proximal inner surface of the main handle inner cavity 501 is an inclined surface with a diameter gradually decreasing from the proximal end to the distal end, the proximal sealing rubber pad 7 is arranged in the main handle inner cavity 501, and the distal outer surface of the proximal sealing rubber pad 7 is in contact with the inclined surface; at least one proximal sealing rubber pad is provided on the proximal sealing rubber pad An instrument channel 71 axially penetrates the proximal sealant; the proximal handle 6 rotates relative to the main handle 5 while axially squeezing the proximal sealant in the distal direction or releasing it in the proximal direction, so that the instrument channel 71 is radially compressed or radially expanded. In this optional embodiment, by providing a proximal sealant pad 7, after the branch guide wire 400 is super-selected into the target blood vessel, when other instruments are inserted along the branch guide wire 400 through the central lumen 11 of the sheath body 100, the sealing of the gap between the outer wall of the branch guide wire 400 or the inserted instrument and the side wall of the main handle inner cavity 501 at the proximal end of the main handle 5 is maintained to prevent bleeding.

[0073] Continue to refer to Figure 8 In an optional embodiment of the aortic branch superselection device provided in the present application, the operating handle 200 also includes a dustproof sleeve 8; the proximal handle 6 includes a proximal cylindrical section 61 and a distal cylindrical section 62 which are integrally connected along the axial direction, the distal cylindrical section 62 is inserted into and threadedly connected to the proximal interior of the main handle 5, and a lap protrusion 611 extending circumferentially along the proximal cylindrical section 61 is provided on the distal surface of the proximal cylindrical section 61; the dustproof sleeve 8 is sleeved on the outside of the lap protrusion 611, and the proximal end of the dustproof sleeve 8 is threadedly connected to the lap protrusion 611, and the distal inner surface of the dustproof sleeve 8 is in contact with the proximal outer surface of the main handle 5 and can slide along the axial direction of the main handle 5. In the structure of this optional embodiment, it is also possible to further, as Figure 8 As shown, an outer flange 503 is provided on the outer side wall of the proximal end of the main handle 5, and an inner boss 801 is provided on the inner side wall of the distal end of the dustproof sleeve 8, so that the inner boss 801 is located on the distal side of the outer flange 503 to limit the distal end of the dustproof sleeve 8.

[0074] In addition, in an optional embodiment of the aortic branch superselection device provided in the present application, a push-pull wire channel 502 is also provided in the inner cavity 501 of the main handle, and a distal sealing rubber sleeve 9 (optionally but not limited to being made of silicone) is provided inside the push-pull wire channel 502. The push-pull wire passes through the distal sealing rubber sleeve 9 and the push-pull wire channel 502, and the push-pull wire is interference fit with the distal sealing rubber sleeve 9. Under the action of the extrusion force of the distal sealing rubber sleeve 9, the gap between the inner wall of the push-pull wire channel 502 and the hard push-pull wire 32 is sealed.

[0075] Finally, it should be noted that the above embodiments and their optional implementation modes in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned optional implementation modes, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

Claims

1. A self-anchoring aortic branch superselective sheath, characterized in that: It comprises a sheath tube main body (100) and at least one set of sheath tube positioning structures arranged on the sheath tube main body (100); The sheath tube body (100) has an inner cavity, the inner cavity includes a central lumen (11), and a branch superselective side hole (111) communicating with the central lumen (11) is provided on a side wall of the sheath tube body (100) near the distal end region; Each group of the sheath tube positioning structures comprises an anchoring member (2), the anchoring member (2) comprising an end collar (21) and at least two anchoring arms (22) evenly spaced and arranged along the circumference of the end collar (21), the two ends of the anchoring arm (22) in the axial direction being respectively an anchoring arm first end (221) and an anchoring arm second end (222), the anchoring arm first end (221) being fixed or integrally connected to the end collar (21), and the anchoring arm second end (222) being suspended in the air; the end collar (21) The anchor arm (222) is sleeved on the outside of the sheath body (100) and is axially limited to the outer wall of the sheath body (100); the second end (222) of the anchor arm has a contracted state in which it is radially contracted along the sheath body (100) and an expanded state in which it is radially expanded along the sheath body (100); the anchor arm (22) is made of an elastic material or an elastic member is connected between the anchor arm (22) and the outer wall of the sheath body (100), so that the anchor arm (22) is in the expanded state when it is freely released; Each group of the sheath tube positioning structures further comprises a retractable assembly (3) corresponding to the anchoring member (2), wherein the retractable assembly (3) comprises a retractable tube (31) and a hard push-pull wire (32); The retractable tube (31) is sleeved on the outside of the sheath tube body (100), the hard push-pull wire (32) passes through the inner cavity of the sheath tube body (100), and the distal end of the hard push-pull wire (32) is fixedly connected to the retractable tube (31); The hard push-pull wire (32) can push and pull the retractable tube (31) axially along the sheath body (100), so that the retractable tube (31) can slide from the first end (221) of the anchoring arm toward the second end (222) of the anchoring arm, thereby radially retracting the second end (222) of the anchoring arm along the sheath body (100), and can slide from the second end (222) of the anchoring arm toward the first end (221) of the anchoring arm, thereby releasing the second end (222) of the anchoring arm.

2. The self-anchoring aortic branch superselective sheath according to claim 1, characterized in that: The sheath positioning structure comprises two groups, one group of anchoring members (2) of the sheath positioning structure is arranged on the distal side of the branch superselection side hole (111), and the other group of anchoring members (2) of the sheath positioning structure is arranged on the proximal side of the branch superselection side hole (111); the second end (222) of the anchoring arm is in a contracted state, the second end (222) of the anchoring arm of the anchoring member (2) located on the proximal side of the branch superselection side hole (111) is located on the proximal side of the end ring (21), and the second end (222) of the anchoring arm of the anchoring member (2) located on the distal side of the branch superselection side hole (111) is located on the distal side of the end ring (21).

3. The self-anchoring aortic branch superselective sheath according to claim 1, characterized in that: In the anchor member (2): Each of the anchoring arms (22) is a U-shaped coil with a closed second end and two free ends of the first end fixed or integrally connected to the end collar (21); And / or, the end of the second end (222) of each anchoring arm is provided with a flange (2221) that is folded outwardly along the radial direction of the sheath tube body (100) in a contracted state.

4. The self-anchoring aortic branch superselective sheath according to claim 1, characterized in that: In each group of the sheath tube positioning structure, the second end (222) of the anchoring arm is in a contracted state, the end of the retractable tube (31) close to the first end (221) of the anchoring arm is the retractable tube first end (311), and the end of the retractable tube (31) close to the second end (222) of the anchoring arm is the retractable tube second end (312): an axial limiting portion of the retractable tube is also provided on the outer wall of the sheath tube body (100) to block at least part of the retractable tube (31) along the axial direction of the sheath tube body (100) at the side of the second end (222) of the anchoring arm facing the end ring (21).

5. The self-anchoring aortic branch superselective sheath according to claim 4, characterized in that: The anchoring members (2) are sleeved one by one in circumferential grooves (14) provided on the outer circumferential surface of the sheath tube body (100), and the parts of the sheath tube body (100) located on both sides of each circumferential groove (14) are the first side tube (101) and the second side tube (102): The retractable tube (31) is sleeved on the outside of one of the first side tube (101) and the second side tube (102) facing the first end (311) of the retractable tube, and the outer diameter of one of the first side tube (101) and the second side tube (102) facing the second end (312) of the retractable tube is greater than the outer diameter of the second end (312) of the retractable tube.

6. The self-anchoring aortic branch superselective sheath according to claim 1, characterized in that: The distal end of the sheath tube body (100) is connected to a guide head (15) whose distal outer peripheral surface is tapered, and a guide wire through hole (151) is provided inside the guide head (15); the guide wire through hole (151) is an eccentric hole whose distal end is concentric with the central lumen (11) and gradually becomes eccentric with the central lumen (11) toward the proximal direction; the inner cavity of the sheath tube body (100) also includes a guide wire cavity (13), and the distal end of the guide wire cavity (13) is connected to the proximal end of the guide wire through hole (151); And / or, a guide component (16) is fixed or integrally connected inside the sheath body (100), the guide component (16) is located on the distal side of the branch superselection side hole (111) and radially closes the central lumen (11) along the sheath body (100), and the proximal surface of the guide component (16) is a guide surface (161) inclined in the direction of the branch superselection side hole (111).

7. An aortic branch superselection device, characterized in that: It comprises an operating handle (200) and a self-anchoring aortic branch superselective sheath according to any one of claims 1 to 6; The operating handle (200) comprises a main handle (5), a driving member (51) and a transmission member (52); The proximal end of the sheath body (100) is fixedly connected to the distal end of the main handle (5), the main handle (5) having a main handle inner cavity (501) communicating with the inner cavity of the sheath body (100), and the proximal end of the main handle (5) is provided with an instrument lower inlet communicating with the main handle inner cavity (501); The driving member (51) is movably mounted on the main handle (5), the transmission member (52) is axially slidably mounted in the inner cavity (501) of the main handle and is transmission-connected to the driving member (51), the proximal end of the hard push-pull wire (32) penetrates into the inner cavity (501) of the main handle and is connected to the transmission member (52), and the driving member (51) can drive the transmission member (52) to push and pull the hard push-pull wire (32) along the axial direction of the sheath tube body (100).

8. The aortic branch superselection device according to claim 7, characterized in that: The operating handle (200) further comprises a proximal handle (6) and a proximal sealing rubber pad (7); The lower instrument entrance of the main handle (5) is arranged on the proximal end surface of the main handle (5), and the distal end of the proximal handle (6) is threadedly sleeved with the proximal end of the main handle (5); The inner surface of the proximal end of the main handle inner cavity (501) is an inclined surface whose diameter gradually decreases from the proximal end to the distal end; the proximal end sealing rubber pad (7) is arranged in the inner cavity (501) of the main handle, and the outer surface of the distal end of the proximal end sealing rubber pad (7) is in contact with the inclined surface; at least one instrument channel (71) is provided on the proximal end sealing rubber and axially passes through the proximal end sealing rubber; The proximal handle (6) rotates relative to the main handle (5) while squeezing the proximal sealant axially in the distal direction or releasing it in the proximal direction, so as to radially compress or radially expand the instrument channel (71).

9. The aortic branch superselection device according to claim 8, characterized in that: The operating handle (200) further comprises a dustproof sleeve (8); The proximal handle (6) comprises a proximal cylindrical section (61) and a distal cylindrical section (62) which are integrally connected along the axial direction; the distal cylindrical section (62) is inserted into and threadedly connected to the proximal interior of the main handle (5); and a lap protrusion (611) extending along the circumference of the proximal cylindrical section (61) is provided on the distal end surface of the proximal cylindrical section (61); The dustproof sleeve (8) is sleeved on the outside of the overlapping protrusion (611), and the proximal end of the dustproof sleeve (8) is threadedly connected to the overlapping protrusion (611), and the distal inner surface of the dustproof sleeve (8) is in contact with the proximal outer surface of the main handle (5) and can slide along the axial direction of the main handle (5).

10. The aortic branch superselection device according to claim 7, characterized in that: A push-pull wire channel (502) is provided in the inner cavity (501) of the main handle, a distal sealing rubber sleeve (9) is provided inside the push-pull wire channel (502), the push-pull wire passes through the distal sealing rubber sleeve (9) and the push-pull wire channel (502), and the push-pull wire and the distal sealing rubber sleeve (9) are interference fit.

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