CN118216965B - Vascular occluder - Google Patents

Abstract

The invention discloses a vascular occluder, which relates to the technical field of medical appliances and comprises a balloon catheter assembly, a skeleton supporting assembly, a hemostatic member, an outer catheter sheath and an inner catheter sheath, wherein the inner catheter sheath is arranged in the outer catheter sheath. The skeleton supporting component comprises a first skeleton and a second skeleton, the hemostatic piece and the first skeleton are sequentially sleeved on the inner catheter sheath along the direction from the proximal end to the distal end, the second skeleton and the hemostatic piece are arranged in the outer catheter sheath, and the first skeleton is arranged outside the outer catheter sheath. When the balloon stretches out from the distal end of the inner catheter sheath and is inflated, the first framework can be pressed on the distal end of the outer catheter sheath by pulling the balloon in the proximal direction until the first framework is in an unfolding state, the second framework is connected with the first framework through the traction wire, the second framework can be in the unfolding state by tightening the traction wire, and the first framework, the hemostatic piece and the second framework are tensioned at the vascular puncture opening.

Description

Vascular occluder

Technical Field

The invention relates to the technical field of medical instruments, in particular to a vascular occlusion device.

Background

Percutaneous access of the vascular system for delivery of vascular devices is a common medical procedure. Typically, this involves puncturing the blood vessel with a hollow needle, and then introducing an introducer sheath to open the puncture site for the introduction of a catheter and guidewire for guiding through the vascular system to facilitate delivery. For example, in many cases vascular access requires the introduction of catheters and guidewires through the femoral artery, and after surgery is completed, the vascular device is removed from the patient and pressure is applied to the puncture site to stop bleeding.

The manual compression hemostasis method is adopted for early hemostasis of the puncture points after femoral artery intervention operation, and the clinical application time of the manual compression hemostasis method is long, but long-time compression hemostasis and bedridden operation not only increase the labor capacity of medical staff, but also increase the pain of patients. In order to overcome the defects of the manual compression hemostasis method, the percutaneous artery plugging device is pushed out, and the effect of hemostasis can be quickly achieved without compressing blood vessels or with minimal compression by using the plugging device, and the percutaneous artery plugging device is not influenced by continuous anticoagulation. The application of the plugging device can shorten the hemostatic time and the bedridden time, and relieve the pain of patients and the strength of medical care.

The current vascular plugging device has the defects of inconvenient operation, longer hemostatic time, poor hemostatic effect and the like, and some impurities of the vascular plugging device are easy to remain in blood vessels. Therefore, how to solve at least one of the above problems is a technical problem to be solved by those skilled in the art.

Disclosure of Invention

Accordingly, the present invention is directed to a vascular occlusion device for improving the operation convenience of the vascular occlusion device.

In order to achieve the above purpose, the present invention provides the following technical solutions:

a vascular occluder, comprising a balloon catheter assembly, a skeleton supporting assembly, a hemostatic member, a shell assembly and a tensioning device;

the balloon catheter assembly comprises a balloon and a lumen tube, wherein the balloon is arranged at the distal end of the lumen tube and is communicated with the lumen tube;

The housing assembly comprises an outer catheter sheath and a handle, the outer catheter sheath is arranged at the distal end of the handle;

The tensioning device comprises an inner catheter sheath and a sliding block, the inner catheter sheath is arranged in the outer catheter sheath, the inner catheter sheath is used as a delivery channel of the balloon catheter assembly, and the sliding block is connected to the proximal end of the inner catheter sheath and is slidably arranged on the handle;

The framework support assembly comprises two folding frameworks, wherein the two folding frameworks are a first framework and a second framework respectively, the second framework is connected with the first framework along the direction from the proximal end to the distal end, the hemostatic member and the first framework are sequentially sleeved on the inner catheter sheath, the first framework is used for being arranged outside the outer catheter sheath and can be folded into an unfolding state from a conveying state under the compression of the balloon and the outer catheter sheath, and the second framework is used for being arranged in the outer catheter sheath and connected with the first framework through a traction wire and can be folded into the unfolding state from the conveying state under the tension of the traction wire.

Optionally, in the vascular occlusion device above, the folding skeleton includes:

the first lock catch is provided with a first avoiding hole for the inner catheter sheath to pass through;

the second lock catch is arranged at the proximal end of the first lock catch and is provided with a second avoiding hole for the inner catheter sheath to pass through;

The connecting rod assembly is hinged to be connected to multiple groups between the first lock catch and the second lock catch, the connecting rod assembly comprises multiple connecting rods hinged to each other, the first lock catch and the second lock catch are separated by a first distance when the folding framework is in a conveying state, each connecting rod of the connecting rod assembly extends along the axial direction, the first lock catch and the second lock catch are separated by a second distance when the folding framework is in an unfolding state, and the connecting rod assembly is folded in a direction away from the central axis of the first lock catch, and the second distance is smaller than the first distance.

Optionally, in the vessel occluder described above, a first locking mating portion is provided at an end of the first lock facing the second lock, a second locking mating portion is provided at an end of the second lock facing the first lock, one of the first locking mating portion and the second locking mating portion is a locking groove, the other is a locking protrusion, and when the folding skeleton is in an unfolded state, the first locking mating portion and the second locking mating portion are engaged and mated.

Optionally, in the vascular occlusion device, the link assembly includes two hinged links, and the links are provided with films, and when the folding skeleton is in an unfolded state, each group of links forms an umbrella-shaped bracket for expanding the films.

Optionally, in the vessel occluder, a distal end of the outer catheter sheath is of a necking structure and is opposite to a proximal end of the first framework;

The distal end of the second framework is a tapered guiding structure, and the guiding structure is used for enabling the second framework to deviate from the outer catheter sheath from the necking structure.

Optionally, in the vascular occlusion device described above, a first tensioning hole and a second tensioning hole are provided on the first framework, a third tensioning hole and a fourth tensioning hole are provided on the second framework, and the first tensioning hole, the second tensioning hole, the third tensioning hole and the fourth tensioning hole are all penetrated along the axial direction of the inner catheter sheath;

The traction wire passes through the third tensioning hole, the first tensioning hole, the second tensioning hole and the fourth tensioning hole in sequence, the fixed end of the traction wire is positioned and arranged at the proximal end of the third tensioning hole, the movable end of the traction wire is penetrated out from the proximal end of the fourth tensioning hole and connected to the sliding block, an anti-loosening buckle is arranged on the traction wire, and the anti-loosening buckle is positioned between the sliding block and the second framework.

Optionally, in the vascular occlusion device, the anti-loosening buckle may be slidably disposed on the traction wire in a unidirectional manner, and is a tubular structure with a tapered tube diameter, and a large-diameter end of the anti-loosening buckle faces the second framework.

Optionally, in the vessel occluder described above, the handle is provided with a handle groove, the slider is slidably disposed in the handle groove, and the handle has a handle portion exposed in the handle groove.

Optionally, in the vessel occluder, a catheter seat is connected to the proximal end of the inner lumen, a catheter reinforcement is sleeved outside the inner lumen, and the distal end of the catheter reinforcement is opposite to the slider and is driven by the slider to slide towards the proximal end.

Optionally, in the vascular occlusion device described above, the folded scaffold, the hemostatic member and the pull wire are all made of biodegradable materials; and/or the number of the groups of groups,

The hemostatic member is a collagen fold.

The vascular occluder provided by the invention is used for occluding and stopping bleeding of a vascular puncture, and comprises a balloon catheter assembly, a framework supporting assembly, a hemostatic piece, a shell assembly and a tensioning device. The balloon catheter assembly comprises a balloon and an inner cavity tube, the balloon is arranged at the distal end of the inner cavity tube and is communicated with the inner cavity tube, the inner cavity tube can convey liquid medium or gaseous medium into the balloon to enable the balloon to be inflated, and the liquid medium or the gaseous medium is extracted to enable the balloon to be decompressed and contracted. The housing assembly includes an outer catheter sheath and a handle, the outer catheter sheath being disposed at a distal end of the handle, the handle being adapted for handheld operation by a medical practitioner. The tensioning device comprises an inner catheter sheath and a sliding block, wherein the inner catheter sheath is arranged in the outer catheter sheath and can axially move in the outer catheter sheath, the inner cavity of the inner catheter sheath is used as a delivery channel of the balloon catheter assembly and can be used for the balloon to enter and exit a blood vessel, the sliding block is connected to the proximal end of the inner catheter sheath and can be slidably arranged on the handle, and the sliding block can be slid on the handle to drive the inner catheter sheath to axially move in the outer catheter sheath. The slider has an axial through bore in communication with the inner catheter sheath for passage of the balloon catheter assembly.

The framework support assembly comprises two folding frameworks, the two folding frameworks are defined to be a first framework and a second framework respectively, the two folding frameworks are smaller in radial size, so that the two folding frameworks can be conveyed by the shell assembly and the tensioning device in a conveying state, the radial size is larger, the unfolding state of the vascular wall can be clamped, the second framework, the hemostatic piece and the first framework are sequentially sleeved on the inner catheter sheath along the direction from the proximal end to the distal end, the second framework and the hemostatic piece are arranged in the outer catheter sheath, and the first framework is arranged outside the outer catheter sheath. When the balloon stretches out from the distal end of the inner catheter sheath and is inflated, the shell component is kept motionless, the inner cavity tube is pulled towards the proximal end direction, the balloon can compress the first framework towards the direction of the outer catheter sheath until the first framework is folded into an unfolding state from a conveying state, the second framework is connected with the first framework through a traction wire, the second framework can be folded into the unfolding state from the conveying state by tightening the traction wire, and the first framework, the hemostatic piece and the second framework are axially tensioned.

In the specific implementation process, the outer catheter sheath is stretched into the blood vessel, then the balloon is conveyed into the blood vessel through the inner cavity of the inner catheter sheath, so that the balloon and the first framework are stretched into the blood vessel, or the balloon is positioned at the distal end of the inner catheter sheath and stretches out before the hemostatic operation is implemented, and the outer catheter sheath and the balloon can be stretched into the blood vessel together at the moment to start the hemostatic operation; then medium is introduced into the balloon to enable the balloon to be inflated, the sliding block is pulled towards the proximal end, the sliding block moves towards the proximal end and pushes the catheter reinforcement piece at the proximal end of the balloon catheter assembly, the balloon catheter assembly integrally moves towards the proximal end, the balloon can further prop against the first framework and tightly press the first framework towards the direction of the catheter sheath until the first framework is converted from a conveying state to an unfolding state, the inner wall of a blood vessel is propped against and positioned, and then the balloon can be decompressed to withdraw from the balloon catheter assembly; and then the vascular occlusion device is pulled to the proximal end, as the first framework is fixed in the blood vessel and cannot move, the second framework is connected with the first framework through the traction wire, the second framework and the hemostatic member can be separated from the outer catheter sheath, the second framework can be tightly pressed towards the direction of the first framework by tightening the traction wire, the hemostatic member is tightly pressed on the outer wall of the blood vessel, and finally, the anti-loose buckle is used for fixing and shearing off the redundant traction wire, so that the operation is completed. After the operation is completed, the first framework and the second framework are respectively pressed on the inner wall and the outer wall of the blood vessel puncture, and the hemostatic piece is pressed on the blood vessel puncture to realize hemostasis.

Compared with the prior art, the vascular occlusion device provided by the invention has the advantages that the vascular puncture is blocked through the first framework, the hemostatic piece and the second framework, the operation is simple, and the hemostatic effect is good.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is an isometric view of a vascular occlusion device according to an embodiment of the present invention;

fig. 2 is a front view of a vascular occlusion device according to an embodiment of the present invention;

FIG. 3 is a cross-sectional view of a vascular occlusion device according to an embodiment of the present invention;

FIG. 4 is an enlarged view of FIG. 3 at A;

FIG. 5 is an enlarged view at B in FIG. 3;

FIG. 6 is a schematic view of a first frame according to an embodiment of the present invention in an expanded state;

FIG. 7 is a cross-sectional view of a first frame according to an embodiment of the present invention in an expanded state;

FIG. 8 is an enlarged view of FIG. 7 at C;

Fig. 9 is an enlarged view of D in fig. 7;

FIG. 10 is a schematic view of a second frame according to an embodiment of the present invention in an expanded state;

FIG. 11 is a cross-sectional view of a second frame according to an embodiment of the present invention in an expanded state;

FIG. 12 is an enlarged view at E in FIG. 11;

fig. 13 is an enlarged view of F in fig. 11;

FIG. 14 is a schematic view of a portion of a vascular occlusion device according to an embodiment of the present invention remaining in a patient;

FIG. 15 is a cross-sectional view of the portion of a vascular occlusion device disclosed in an embodiment of the present invention remaining in a patient;

FIG. 16 is an isometric view of a folded scaffold disclosed in an embodiment of the present invention in a transport state;

FIG. 17 is a front view of a folded scaffold disclosed in an embodiment of the present invention in a transport state;

FIG. 18 is a cross-sectional view of a folded scaffold disclosed in an embodiment of the present invention in a transport state;

FIG. 19 is an isometric view of a folded armature in an unfolded state as disclosed in an embodiment of the invention;

FIG. 20 is a front view of a folding skeleton in an unfolded state, according to an embodiment of the present invention;

FIG. 21 is a cross-sectional view of a folded armature in an unfolded state, according to an embodiment of the invention;

FIG. 22 is a side view of a folded armature in an unfolded state, according to an embodiment of the invention;

FIG. 23 is a schematic drawing showing the tightening of the traction wire according to the embodiment of the present invention;

fig. 24 is a schematic structural view of a locking element according to an embodiment of the present invention;

Fig. 25 is a schematic view illustrating a sliding direction of the locking element according to an embodiment of the present invention.

Wherein 100 is a balloon catheter assembly, 110 is a balloon, 120 is a delivery tube lumen tube, 130 is a catheter holder, and 140 is a catheter stiffener;

200 is a framework supporting component, 210 is a folding framework, 211 is a first lock catch, 212 is a second lock catch, 213 is a connecting rod component, 214 is a second locking matching part, 215 is a first locking matching part, 220 is a first framework, and 230 is a second framework;

300, blood piece;

400 is a housing assembly, 410 is a handle, 420 is an outer catheter sheath, 430 is a sheath;

500 is a tensioning device, 510 is a sliding block, 520 is an inner catheter sheath;

600 is a traction wire, 610 is a locking buckle;

700 is a blood vessel.

Detailed Description

The core of the invention is to disclose a vascular occluder to improve the operation convenience of the vascular occluder.

Hereinafter, embodiments will be described with reference to the drawings. Furthermore, the embodiments shown below do not limit the summary of the invention described in the claims. The whole contents of the constitution shown in the following examples are not limited to the solution of the invention described in the claims. For convenience of description, only a portion related to the present invention is shown in the drawings. Embodiments of the invention and features of the embodiments may be combined with each other without conflict.

For ease of description, the end relatively closer to the healthcare worker is defined as the proximal end and the end relatively farther from the healthcare worker is defined as the distal end. For a single member, the end closer to the healthcare worker is the proximal end, the end farther from the healthcare worker is the distal end, and the axial direction is along the proximal-to-distal direction.

Referring to fig. 1-25, a vascular occlusion device for occluding and stopping bleeding at a vascular puncture is disclosed in an embodiment of the present invention, and includes a balloon catheter assembly 100, a scaffold support assembly 200, a hemostatic member 300, a housing assembly 400, and a tensioning device 500.

Balloon catheter assembly 100 includes a balloon 110 and a lumen tube 120, balloon 110 being disposed at a distal end of lumen tube 120 and in communication with lumen tube 120, lumen tube 120 being capable of delivering a liquid or gaseous medium into balloon 110 to inflate balloon 110, and withdrawing the liquid or gaseous medium to deflate balloon 110, balloon 110 being in a deflated state during balloon 110 entry into vessel 700 or withdrawal from vessel 700.

The housing assembly 400 includes an outer catheter sheath 420 and a handle 410, the outer catheter sheath 420 being disposed at a distal end of the handle 410, the handle 410 being adapted for handheld operation by a medical practitioner.

The tensioning device 500 comprises an inner catheter sheath 520 and a slider 510, wherein the inner catheter sheath 520 is arranged in the outer catheter sheath 420 and can axially move in the outer catheter sheath 420, the inner cavity of the inner catheter sheath 520 is used as a delivery channel of the balloon catheter assembly 100 for the balloon 110 to enter and exit the blood vessel 700, the slider 510 is connected to the proximal end of the inner catheter sheath 520 and can be slidably arranged on the handle 410, and the inner catheter sheath 520 can be driven to axially move in the outer catheter sheath 420 by sliding the slider 510 on the handle 410. The slider 510 has an axial through bore in communication with the inner catheter sheath 520 for passage of the balloon catheter assembly 100.

The stent support assembly 200 includes two folding stents 210, for convenience of description, two folding stents 210 are defined as a first stent 220 and a second stent 230, respectively, each of the two folding stents 210 has a smaller radial size, so as to be capable of being delivered by the housing assembly 400 and the tensioning device 500, and a larger radial size, so as to clamp an expanded state of a vessel wall, and the second stent 230, the hemostatic member 300 and the first stent 220 are sequentially sleeved on the inner catheter sheath 520 along a proximal-to-distal direction, wherein the second stent 230 and the hemostatic member 300 are disposed in the outer catheter sheath 420, and the first stent 220 is disposed outside the outer catheter sheath 420. When the balloon 110 extends from the distal end of the inner catheter sheath 520 and is inflated, the first skeleton 220 is pressed against the outer catheter sheath 420 by the balloon 110 until the first skeleton 220 is folded from the delivery state to the deployment state, the second skeleton 230 is connected to the first skeleton 220 by the pull wire 600, the second skeleton 230 can be folded from the delivery state to the deployment state by tightening the pull wire 600, and the first skeleton 220, the hemostatic member 300, and the second skeleton 230 can be axially tensioned by tightening the pull wire 600, and the pull wire 600 can be fixed by means of the anti-loosening buckle 610. The hemostatic member 300 is disposed within the outer catheter sheath 420 and is ultimately compressed by the second scaffold 230 from outside the vessel wall at the vascular puncture site without entering the blood vessel 700 to avoid affecting the normal function of the blood vessel 700.

In a specific implementation process, the outer catheter sheath 420 is first stretched into the blood vessel 700, then the balloon 110 is conveyed into the blood vessel 700 through the inner cavity of the inner catheter sheath 520, so that the balloon 110 and the first skeleton 220 are stretched into the blood vessel 700, or referring to fig. 3, before the hemostasis operation is implemented, the balloon 110 is already positioned at the distal end of the inner catheter sheath 520 and stretches out, and at the moment, the outer catheter sheath 420 and the balloon 110 can be directly stretched into the blood vessel 700 at the same time to start the hemostasis operation; then, medium is introduced into the balloon 110 to enable the balloon 110 to be inflated, referring to fig. 8, the sliding block 510 is pulled proximally, the sliding block 510 pushes the catheter reinforcement member 140 at the proximal end of the balloon catheter assembly 100, the whole balloon catheter assembly 100 moves in the proximal direction, the balloon 110 abuts against the first framework 220 and compresses the first framework 220 towards the outer catheter sheath 420 until the first framework 220 is converted from a delivery state to a deployment state and abuts against the inner wall of the blood vessel 700, and then the balloon 110 is decompressed to withdraw the balloon catheter assembly 100; then, the vascular occlusion device is pulled proximally, since the first framework 220 is fixed in the blood vessel 700 and cannot move, and the second framework 230 is connected with the first framework 220 through the pulling wire 600, the second framework 230 and the hemostatic member 300 are separated from the outer catheter sheath 420, see fig. 12, at this time, the pulling wire 600 is pulled tightly to compress the second framework 230 in the direction of the first framework 220, and simultaneously compress the hemostatic member 300 on the outer wall of the blood vessel, and finally, the anti-loose buckle 610 is used for fixing and cutting off the redundant pulling wire 600, thus completing the operation. Referring to fig. 14 and 15, after the operation is completed, the first and second bobbins 220 and 230 are respectively compressed on the inner and outer walls of the vascular puncture site, and the hemostatic member 300 is compressed at the vascular puncture site to achieve hemostasis.

Compared with the prior art, the vascular occlusion device disclosed by the embodiment of the invention realizes the occlusion of the vascular puncture through the first framework 220, the hemostatic member 300 and the second framework 230, and has the advantages of simple operation and good hemostatic effect.

After the hemostasis operation is completed, the portion of the vascular occlusion device reserved in the patient is made of biodegradable materials, that is, the first framework 220, the second framework 230, the hemostasis member 300 and the traction wire 600 (including the anti-loosening buckle 610 on the traction wire 600) are made of biodegradable materials, so that the vascular occlusion device can be catabolized by a human body after a period of time, and impurity residues are avoided.

Specifically, the first and second bobbins 220 and 230 may be made of biodegradable magnesium alloy. Hemostatic member 300 may be a collagen fold and be made of a compressible, biodegradable material, such as a collagen pad made of a fibrous collagen mixture of insoluble and soluble collagen, which may be obtained from connective tissue of an animal, and which may be purified from the subcutaneous layer of bovine hide.

The hemostatic member 300 may be embodied as a collapsible elongate member that may be elongated within the outer catheter sheath 420 when the hemostatic member 300 is unfolded and may be occluded at the vascular puncture site when compressed against the vascular outer wall by the second scaffold 230.

The structures of the first and second bobbins 220 and 230 may be the same or different. The specific structure of the folding skeleton 210 may be various, and it is only necessary to be able to enter the blood vessel 700 (the first skeleton 220) in the delivery state and to be able to be clamped on the vessel wall at the vascular puncture site in the deployed state.

Referring to fig. 16 and 17, in an embodiment, the folding skeleton 210 includes a first latch 211, a second latch 212, and a link assembly 213, the first latch 211 has a first avoidance hole for the inner sheath 520 to pass through, the second latch 212 is disposed at a proximal end of the first latch 211 and has a second avoidance hole for the inner sheath 520 to pass through, the link assembly 213 is a plurality of groups hinged between the first latch 211 and the second latch 212, and the link assembly 213 includes a plurality of links hinged, during the conveying process, the first latch 211 and the second latch 212 are spaced apart by a first distance, each link of the link assembly 213 extends along an axial direction of the inner sheath 520, so that the folding skeleton 210 is in a conveying state, when the first latch 211 and the second latch 212 are pressed by an external force, a distance between the two is shortened to a second distance, and the links are folded in an outer circumferential direction of the first latch 211 and the second latch 212, that is, in a direction away from a central axis of the first latch 211 and the second latch 212, so as to form a contact positioning with a large area of a blood vessel wall.

The link assembly 213 may be a plurality, for example, three as shown in fig. 19, which are uniformly disposed along the circumferential direction of the first locker 211. The link assembly 213 includes at least two links hinged to each other at their ends, and the non-hinged ends of the two links are hinged to the first latch 211 and the second latch 212, respectively. Referring to fig. 20 to 22, when the first backbone 220 is subjected to the pressure of the balloon 110 and the supporting force of the distal end of the outer catheter sheath 420, the link assembly of the first backbone 220 is folded toward the middle of the first and second latches and opened toward the periphery to form an umbrella-like or disc-like structure; when the first and second catches of the second armature 230 approach each other under tension of the traction wire 600, the link assembly 213 of the second armature also expands circumferentially into an umbrella-like configuration.

In order to increase the contact area between the folded skeleton 210 and the blood vessel wall after being unfolded, the connecting rod assemblies 213 are further provided with films, and when the folded skeleton 210 is in an unfolded state, each group of connecting rod assemblies 213 forms an umbrella-shaped support for expanding the films. The provision of the membrane can increase the contact area with the vessel wall after the folding skeleton 210 is unfolded, thereby reducing the irritation to the vessel wall.

Further, referring to fig. 18, a first locking matching portion 215 is disposed at an end of the first lock catch 211 facing the second lock catch 212, a second locking matching portion 214 is disposed at an end of the second lock catch 212 facing the first lock catch 211, one of the first locking matching portion 215 and the second locking matching portion 214 is a locking groove, the other is a locking protrusion, when the folding skeleton 210 is axially stressed, the first lock catch 211 and the second lock catch 212 are close to each other until the first locking matching portion 215 and the second locking matching portion 214 are embedded and matched, so that positions of the first lock catch 211 and the second lock catch 212 are relatively fixed, and the first skeleton 220 and the second skeleton 230 are maintained in an unfolded state.

Taking the first skeleton 220 as an example, the first skeleton 220 receives pressure from the balloon 110 and supporting force of the outer catheter sheath 420 in the deformation process, and under the interaction of the two forces, the first lock catch and the second lock catch of the first skeleton 220 approach each other until the locking protrusion is embedded into the locking groove after being subjected to transient elastic deformation, so as to realize the maintenance of the unfolded state of the first skeleton 220.

After the first framework 220 is tensioned and then is tightly attached to the inner wall of the blood vessel, the traction wire 600 is pulled to enable the second framework 230 to move towards the direction of the first framework 220, the hemostatic 300 is compressed, folded and blocked on the outer side of the blood vessel wall, the traction wire 600 is continuously tightened, the second framework 230 is acted by the pressure of the traction wire 600 and the supporting force of the outer wall of the blood vessel, and the first lock catch and the second lock catch of the second framework 230 are mutually embedded, so that the unfolded state of the second framework 230 is kept. In the process of folding the second framework 230, the hemostatic member 300 is compressed and folded synchronously, and after the first lock catch and the second lock catch of the second framework 230 are locked mutually, the vascular wound and the hemostatic member 300 are clamped between the first framework 220 and the second framework 230 synchronously, so that the vascular puncture can be plugged.

The first framework 220 is configured to be disposed outside the outer catheter sheath 420, so as to facilitate supporting and compressing the first framework 220, and the distal end of the outer catheter sheath 420 is of a necking structure, see fig. 12, that is, the diameter of the distal end of the outer catheter sheath 420 is gradually reduced, so as to be opposite to the end face of the proximal end of the first framework 220, to achieve abutting, without pressing the first framework 220 into the outer catheter sheath 420 by the balloon 110 during the folding and deforming process of the first framework 220, and meanwhile, the necking structure of the outer catheter sheath 420 does not affect the pulling out of the hemostatic 300 and the second framework 230 from the outer catheter sheath 420.

Referring to fig. 17, the structures of the first lock catch 211 and the second lock catch 212 may be symmetrically disposed with respect to each other, and both the structures of the first lock catch 220 and the second lock catch 230 are cylindrical, and when the structures of the first framework 220 and the second framework 230 are identical, that is, the structures of the second lock catch of the first framework 220 and the first lock catch of the second framework 230 are identical, in order to avoid the effect of the necking structure of the distal end of the outer catheter sheath 420 on the release of the second framework 230 from the outer catheter sheath 420, the distal end of the second framework 230, that is, the distal end of the first lock catch of the second framework 230, is a tapered guiding structure, so as to facilitate the release of the second framework 230 from the distal end of the outer catheter sheath 420. Specifically, the minimum diameter of the distal reduction structure of the outer catheter sheath 420 is greater than the minimum diameter of the distal guiding structure of the second scaffold 230.

Referring to fig. 2 and 3, since the first scaffold 220 and a portion of the inner sheath 520 are positioned outside the outer sheath 420, in order to achieve protection of the first scaffold 220 and the inner sheath 520, the housing assembly 400 further includes a sheath 430, the sheath 430 being detachably disposed at the distal end of the outer sheath 420 and protecting the distal ends of the first scaffold 220 and the inner sheath 520, the sheath 430 being removed from the outer sheath 420 before performing a hemostatic operation.

Referring to fig. 4, 5 and 23, the tension between the first and second bobbins 220 and 230 is achieved by the traction wire 600, specifically, the first and second tension holes are provided on the first bobbin 220, the third and fourth tension holes are provided on the second bobbin 230, and the first, second, third and fourth tension holes are all penetrated in the axial direction of the inner catheter sheath 520; the traction wire 600 sequentially passes through the third tensioning hole and the first tensioning hole, and after being folded back from the distal end of the first framework 220, the traction wire 600 continuously passes through the second tensioning hole and the fourth tensioning hole, the fixed end of the traction wire 600 is positioned and arranged at the proximal end of the third tensioning hole, the movable end of the traction wire 600 passes through the proximal end of the fourth tensioning hole, and the anti-loosening buckle 610 is arranged on the traction wire 600. After the second frame 230 is pulled in the direction of the first frame 220, the hemostatic member 300, and the second frame 230 can be compressed by adjusting the position of the anti-loosening knot 610 on the traction wire 600.

Wherein, the fixed end of the traction wire 600 can be provided with a knot to realize the abutting limit of the traction wire 600 and the proximal end wall of the third tensioning hole. The anti-loosening button 610 is formed of a biodegradable material, preferably absorbable iron, stainless steel, magnesium alloy, or the like.

The anti-loosening buckle 610 may have various structural forms, in an embodiment, referring to fig. 24 and 25, the anti-loosening buckle 610 may be slidably disposed on the traction wire 600 in a one-way manner, and has a tubular structure with a tapered tube diameter, and the large diameter end of the anti-loosening buckle 610 faces the second framework 230, so that the anti-loosening buckle 610 can only slide towards the fixed end of the traction wire 600, and after the traction wire 600 is pulled tightly to fold the hemostatic 300 and the second framework 230, the anti-loosening buckle 610 can be manually pushed to the proximal end of the second framework 230, so as to prevent the traction wire 600 from loosening and affecting the blocking effect.

Specifically, the locking buckle 610 is a cylindrical thin-walled metal ring prior to installation into the vascular occlusion device. After the anti-loosening button 610 is threaded onto the traction wire 600, the anti-loosening button 610 is pressed into a truncated cone shape by using a pressing device, at this time, the narrow opening (small diameter end) of the truncated cone is in interference with the traction wire 600, and the wide opening (large diameter end) is in clearance with the traction wire 600. This structure makes the anti-loosening buckle 610 smoothly slide on the traction wire 600 when moving in the direction of the fixed end (direction indicated by arrow in fig. 25) relative to the traction wire 600, and makes the anti-loosening buckle 610 have only a unidirectional movement function when moving in the direction of the movable end of the traction wire 600 (direction indicated by arrow in fig. 25), because the narrow opening is in interference with the traction wire 600, the anti-loosening buckle is prevented from moving in the direction of the movable end of the traction wire 600 due to resistance from the traction wire 600 when moving.

Further, the traction wire 600 passes through the hemostatic member 300, i.e. the traction wire 600 passes through the third tensioning hole, the (first position of the) hemostatic member 300, the first tensioning hole, the second tensioning hole, the (second position of the) hemostatic member 300 and the fourth tensioning hole in order to ensure that the hemostatic member 300 does not deviate from the intermediate positions of the first and second skeletons 220, 230 during tensioning of the first and second skeletons 220, 230.

In order to facilitate the sliding of the slider 510, a handle groove is provided on the handle 410, the slider 510 is slidably disposed in the handle groove, and the handle 410 has a handle portion exposed from the handle groove for manual operation by a medical staff by limiting the axial movement travel of the slider 510 relative to the handle 410. Referring to fig. 13, the slider 510 may be provided in a T-shape or the like.

Specifically, in one embodiment, referring to fig. 7 and 9, the proximal end of the inner tube 120 is connected to the catheter holder 130, the inner tube 120 is sleeved with the catheter reinforcement member 140, the distal end of the catheter reinforcement member 140 is opposite to the slider 510, and when the slider 510 is slid in the proximal direction relative to the handle 410, the proximal end of the slider 510 can push the catheter reinforcement member 140 to move the inner tube 120 and the catheter holder 130 in the proximal direction. At this time, the sliding stroke of the handle 410 may be set to be equal to the folding stroke of the first frame 220.

In practice, when the balloon 110 is inflated, the slider 510 is pulled proximally, and the slider 510 can move proximally against the catheter stiffener 140, such that the balloon 110 moves proximally simultaneously, the balloon 110 abuts the first armature 220, and pressure is applied to the distal end of the first armature 220.

Further, in an embodiment, the proximal end of the pull wire 600 is fixed to the slider 510 after being passed through the fourth tightening hole, so that when the slider 510 is pulled proximally to compress the first frame 220, the slider 510 can simultaneously tighten the pull wire 600 to fold the second frame 230 and the hemostatic member 300, and simultaneously facilitate the layout of the pull wire 600 in the vascular occlusion device, and the anti-loosening buckle 610 is disposed on the pull wire 600 between the second frame 230 and the slider 510.

A balloon filling cavity communicated with the balloon 110 and a guide wire cavity for a guide wire to pass through are arranged on the inner cavity tube 120, and correspondingly, a balloon flushing and pressure releasing port and a guide wire guiding port are arranged on the catheter seat 130 and communicated with the balloon filling cavity, and the guide wire guiding port is communicated with the guide wire cavity. Liquid or gas can be injected into the balloon filling cavity through the balloon filling and pressure releasing interface to fill the balloon 110, and the balloon 110 can be contracted by extracting the liquid or gas; during the vascular occlusion device intervention in the vessel 700, the guidewire enters from the distal end of the lumen tube 120 and exits the guidewire port through the guidewire lumen. The balloon catheter assembly 100 may be directly applied to existing balloon catheter structures.

In a specific implementation process, the sheath 430 is removed, then the balloon 110 and the first framework 220 extend into the blood vessel 700, liquid or gas is injected into the balloon filling cavity through the balloon filling and pressure releasing interface to make the balloon 110 fully expand, then the slider 510 is pulled proximally, referring to fig. 6 and 7, under the pressure of the balloon 110 and the supporting force of the outer catheter sheath 420, the connecting rod assembly of the first framework 220 is folded, and the first lock catch and the second lock catch are close to each other and locked; the balloon 110 is then deflated to an initial deflated state and the balloon catheter assembly 100 is removed entirely through the inner catheter sheath 520; pulling the handle 410, under the action of the traction wire 600, the first framework 220 is tightly attached to the inner wall of the blood vessel, the hemostatic member 300 and the second framework 230 are pulled out from the outer catheter sheath 420, referring to fig. 10 and 11, continuing to pull the handle 410 to fold the hemostatic member 300 and the second framework 230, locking the first lock catch and the second lock catch of the second framework 230, pushing the locking buckle 610 to the proximal end of the second framework 230 and tightly pressing the locking buckle, tightly attaching the hemostatic member 300 and the second framework 230 to the outer surface of the blood vessel wall, and completing the plugging and closing of the blood vessel puncture after the redundant traction wire 600 is cut off. Finally, the first frame 220, the second frame 230, the hemostatic member 300, the locking buckle 610, and a portion of the pull wire 600 remain in the patient's body, and are catabolized by the human body after a period of time without being removed secondarily.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. The particular means of carrying out some embodiments may be combined in part or whole with another embodiment without being expressly excluded from the other embodiment. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

1. A vascular occluder, characterized by comprising a balloon catheter assembly (100), a skeleton support assembly (200), a hemostatic member (300), a housing assembly (400) and a tensioning device (500);

The balloon catheter assembly (100) comprises a balloon (110) and a lumen tube (120), wherein the balloon (110) is arranged at the distal end of the lumen tube (120) and is communicated with the lumen tube (120);

The housing assembly (400) includes an outer catheter sheath (420) and a handle (410), the outer catheter sheath (420) being disposed at a distal end of the handle (410);

The tensioning device (500) comprises an inner catheter sheath (520) and a sliding block (510), wherein the inner catheter sheath (520) is arranged in the outer catheter sheath (420), the inner catheter sheath (520) is used as a delivery channel of the balloon catheter assembly (100), and the sliding block (510) is connected to the proximal end of the inner catheter sheath (520) and is slidably arranged on the handle (410);

The framework support assembly (200) comprises two folding frameworks (210), wherein the two folding frameworks (210) are respectively a first framework (220) and a second framework (230), the second framework (230) is arranged along the direction from the proximal end to the distal end, the hemostatic piece (300) and the first framework (220) are sequentially sleeved on the inner catheter sheath (520), the first framework (220) is arranged outside the outer catheter sheath (420) and can be folded into an unfolding state from a conveying state under the compression of the sacculus (110) and the outer catheter sheath (420), and the second framework (230) is arranged in the outer catheter sheath (420) and is connected with the first framework (220) through a traction wire (600) and can be folded into the unfolding state from the conveying state under the tensioning of the traction wire (600).

2. The vascular occlusion device of claim 1, wherein the folded scaffold (210) comprises:

A first lock catch (211) provided with a first avoiding hole for the inner catheter sheath (520) to pass through;

a second lock catch (212) arranged at the proximal end of the first lock catch (211) and provided with a second avoiding hole for the inner catheter sheath (520) to pass through;

The connecting rod assembly (213) is hinged to the first lock catch (211) and the second lock catch (212), the connecting rod assembly (213) comprises a plurality of hinged connecting rods, when the folding framework (210) is in a conveying state, the first lock catch (211) and the second lock catch (212) are separated by a first distance, each connecting rod of the connecting rod assembly (213) extends along the axial direction, when the folding framework (210) is in an unfolding state, the first lock catch (211) and the second lock catch (212) are separated by a second distance, and the connecting rod assembly (213) is folded towards a direction away from the central axis of the first lock catch (211), and the second distance is smaller than the first distance.

3. The vascular occlusion device of claim 2, wherein a first locking engagement portion (215) is provided at an end of the first lock catch (211) facing the second lock catch (212), a second locking engagement portion (214) is provided at an end of the second lock catch (212) facing the first lock catch (211), one of the first locking engagement portion (215) and the second locking engagement portion (214) is a locking groove, the other is a locking protrusion, and the first locking engagement portion (215) and the second locking engagement portion (214) are snap-engaged when the folding skeleton (210) is in an unfolded state.

4. The vascular occlusion device of claim 2, wherein said linkage assembly (213) comprises two links hinged, said linkage assembly (213) having a membrane disposed thereon, each set of said linkage assemblies (213) forming an umbrella-like support for expanding said membrane when said folded skeleton (210) is in an expanded state.

5. The vascular occlusion device of any of claims 1-4, wherein a distal end of the outer catheter sheath (420) is of a necked-down configuration and is opposite a proximal end of the first scaffold (220);

the distal end of the second scaffold (230) is a tapered guiding structure for the second scaffold (230) to be pulled out of the outer catheter sheath (420) from the necked-down structure.

6. The vascular occlusion device of any of claims 1-4, wherein a first tensioning aperture and a second tensioning aperture are provided on the first scaffold (220), a third tensioning aperture and a fourth tensioning aperture are provided on the second scaffold (230), the first tensioning aperture, the second tensioning aperture, the third tensioning aperture and the fourth tensioning aperture all being through along an axial direction of the inner catheter sheath (520);

The traction wire (600) sequentially passes through the third tensioning hole, the first tensioning hole, the second tensioning hole and the fourth tensioning hole, the fixed end of the traction wire (600) is positioned and arranged at the proximal end of the third tensioning hole, the movable end of the traction wire is penetrated out of the proximal end of the fourth tensioning hole and connected to the sliding block (510), the traction wire (600) is provided with an anti-loosening buckle (610), and the anti-loosening buckle (610) is positioned between the sliding block (510) and the second framework (230).

7. The vascular occlusion device of claim 6, wherein the locking buckle (610) is slidably disposed on the pull wire (600) in a single direction and has a tubular structure with a tapered tube diameter, and a large diameter end of the locking buckle (610) faces the second frame (230).

8. The vascular occlusion device of any of claims 1-4, wherein the handle (410) is provided with a handle slot, wherein the slider (510) is slidably disposed within the handle slot, and wherein the handle (410) has a grip portion exposed to the handle slot.

9. The vascular occlusion device of claim 8, wherein a catheter hub (130) is attached to a proximal end of said inner lumen (120), said inner lumen (120) being sheathed with a catheter reinforcement (140), a distal end of said catheter reinforcement (140) being opposite said slider (510) for being driven by said slider (510) to slide proximally.

10. The vascular occlusion device of any of claims 1-4, wherein the folded scaffold (210), the hemostatic member (300) and the pull wire (600) are each made of a biodegradable material; and/or the number of the groups of groups,

The hemostatic member (300) is a collagen fold.