Thrombolysis balloonTechnical Field
The invention relates to the technical field of interventional therapy instruments, in particular to a thrombolysis balloon.
Background
Thrombosis refers to the pathological process in which blood-forming components form emboli in blood vessels under certain conditions, causing partial or complete blockage of the blood vessels, and blood supply at corresponding sites is impaired. The main treatment means of the current thrombotic diseases comprise anticoagulation, anti-thrombus, thrombolysis and other drug treatments, surgical treatment, interventional treatment and the like. For those with poor medical treatment effects on old thrombus and poor collateral circulation formation, surgical treatment can be considered, namely, taking out thrombus or cutting off embolic vascular segments by surgery and re-anastomosis. The interventional therapy is to remove thrombus locally through a catheter, suck thrombus through the negative pressure of the catheter and remove thrombus mechanically through instruments such as a balloon, a bracket and the like.
In interventional therapy, a thrombus taking balloon is commonly used, the latex balloon at the front end is pushed and passes over a part with thrombus or embolism by using a corresponding interventional instrument, the latex balloon is filled until the balloon contacts the vessel wall, the catheter is withdrawn, and the thrombus is dragged out of the body along with the balloon.
In the practical process of the existing thrombus taking balloon, the thrombus taking effect is not particularly ideal, and how to design a thrombus taking balloon with better thrombus taking effect is a problem to be solved urgently by the person skilled in the art.
Disclosure of Invention
In view of the above, the present invention provides a thrombolytic balloon to solve the defect of poor thrombolytic effect of the existing thrombolytic balloon, thereby providing a thrombolytic balloon.
In order to solve the technical problems, the technical scheme of the invention is as follows:
A thrombolytic balloon, comprising:
a conduit;
a balloon attached to a distal end of the catheter and capable of expanding radially outward relative to the catheter;
A sliding ring which is connected with the periphery of the catheter in a sliding way along the axial direction of the catheter, and is positioned at the proximal end of the balloon;
The barb assembly comprises a barb bracket, wherein the barb bracket is connected to the sliding ring at the proximal end and connected to the balloon at the distal end, the barb bracket is in a furled state of furling on the periphery of the catheter before or after the balloon is not expanded or is decompressed, and in a unfolded state that the distal end is unfolded outwards relative to the radial direction of the catheter under the action of thrust force when the balloon is radially expanded, and the barb bracket is provided with a spike, and when the barb bracket is in the unfolded state and moves along with the whole catheter towards the proximal end, the spike is suitable for scraping thrombus.
Further, the barb assembly is provided with a plurality of barb assemblies around the circumference of the catheter, the proximal ends of the barb stents are rotatably connected to the sliding ring, and the distal ends of the barb stents are connected to different positions in the circumferential direction of the balloon.
Further, the spines are provided in plurality along the length direction of the barb bracket.
Further, the spike is rotatably connected to the barb support around a fixed shaft, the spike has a flat lying state in which the spike is accommodated in the barb support or the spike is lying on the surface of the barb support in the process of rotating around the fixed shaft, and a standing state in which the spike is arranged at an included angle with the length direction of the barb support and the spike extends outwards from the surface of the barb support, and when the spike is in the standing state, the spike is suitable for scraping thrombus.
Further, a tip portion of the spike is located proximal to the spike when the spike is in the raised state.
Further, when the barb bracket is in a furled state, the spike is in a lying state, when the barb bracket expands from the furled state to the expanded state along with radial expansion of the saccule, the spike synchronously rotates from the lying state to the standing state, and when the barb bracket is furled from the expanded state to the furled state along with decompression retraction of the saccule, the spike synchronously rotates from the standing state to the lying state.
The device comprises a catheter, a barb bracket, a transmission piece, an elastic piece, a spike, a sliding ring, a fixed ring and a connecting piece, wherein the barb bracket is connected with the transmission piece;
when the barb bracket is in a furled state, the elastic piece is in an elastic compression state, and the spike is in a lying state under the thrust action of the transmission piece;
When the barb bracket expands from the furled state to the expanded state along with the radial expansion of the saccule, the proximal end of the barb bracket slides along the axial direction of the catheter along with the sliding ring, the elastic piece is stretched from an elastic compression state to an elastic stretching state, and the spike rotates from the lying state to the standing state under the action of the pulling force of the transmission piece;
When the barb support is folded from the unfolded state to the folded state along with the decompression shrinkage of the saccule, the proximal end of the barb support slides along with the sliding ring along the axial direction of the catheter towards the proximal end, the elastic piece is compressed to an elastic compression state from an elastic stretching state, and the spike rotates from the standing state to the lying state under the thrust action of the transmission piece.
Further, a groove is formed in the barb support, the length direction of the groove is along the length direction of the barb support, the fixed shaft is connected to the side wall of the groove, the transmission piece is connected to the bottom of the groove in a sliding mode, when the spike is in the lying state, the tip end portion of the spike is contained in the groove, and when the spike is in the standing state, the tip end portion of the spike extends outwards from the side notch of the groove.
Further, the side notches of the groove are located on the side of the barb support facing away from the conduit.
Further, the spike comprises a transmission part and a tip part which are positioned at two opposite ends, the transmission part is a linkage rod, the linkage rod is fixedly connected with the transmission part of the spike, or the transmission part is a rack, the transmission part is provided with a gear, and the rack is in meshed transmission connection with the gear of the spike.
The technical scheme of the invention has the advantages that the barbed stent is additionally arranged between the balloon and the sliding ring, the barbed stent is provided with the spines, before the balloon is not expanded, the barbed stent is folded at the periphery of the catheter, the overall outer diameter can be reduced, the trafficability of the catheter is improved, when the balloon is radially expanded, the balloon drives the distal end of the barbed stent to be outwards expanded, the proximal end of the barbed stent can drive the sliding ring to slide a certain distance on the catheter, when the expanded balloon and the barbed stent in the expanded state are integrally and proximally recovered along with the catheter, the spines on the barbed stent scrape the thrombus attached to the vessel wall, the scraped thrombus can be dragged out of the body by the balloon, and compared with the thrombus dragging mode only by the balloon in the prior art, the thrombus taking effect of the thrombus taking balloon can be enhanced.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of a first embodiment of the present invention, in which a balloon in a thrombolysis balloon is in a pressure release state, a barb stand is in a folded state, and a spike is in a lying state;
FIG. 2 is a schematic view of an embodiment of the present invention in which the balloon of the thrombolysis balloon is in an inflated state, the barbed stent is in an expanded state, and the spike is in a three-dimensional state;
FIG. 3 is a cross-sectional view of FIG. 2;
FIG. 4 is an enlarged view of FIG. 3 at A;
FIG. 5 is a schematic view of the structure of the barb bracket, spike, and linkage rod in accordance with the first embodiment of the present invention;
FIG. 6 is a cross-sectional view of FIG. 5;
Fig. 7 is a schematic view of the structure of a barb carrier, spike, and rack in accordance with the second embodiment of the present invention;
FIG. 8 is a cross-sectional view of FIG. 7;
fig. 9 is an enlarged view at B in fig. 8.
The reference numerals comprise 1, a catheter, 2, a balloon, 3, a sliding ring, 4, a barb assembly, 41, a barb bracket, 411, a groove, 42, a spike, 421, a tip part, 422, a transmission part, 43, a fixed shaft, 44, a linkage rod, 45, a rack, 5, a fixed ring and 6, and an elastic piece.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present application, it is to be understood that the terms "proximal" and "distal" are used throughout to refer to proximal and distal with respect to an operator, and that the end of the present application that is proximal to the physician or operator, i.e., the end at which the operator is located, is "distal" to the physician or operator, i.e., the end at which the balloon is located, when used. The foregoing description of orientations is presented only to facilitate a description of the application and to simplify the description, and is not intended to indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operate in a particular orientation, and therefore should not be construed as limiting the application.
Example 1
A thrombolytic balloon as shown in fig. 1-9 comprises a catheter 1, a balloon 2, a sliding ring 3 and a barb assembly 4. The catheter 1 is a multi-cavity tube, a filling channel is arranged in the lumen of the multi-cavity tube, the balloon 2 is connected to the distal end of the catheter 1, the inner cavity of the balloon 2 is communicated with the filling channel in the catheter 1, and the catheter 1 is used for pushing the balloon 2 at the distal end to pass through a part with thrombus or embolism in a blood vessel. The balloon 2 has compliance, for example, the balloon 2 is a latex balloon made of natural latex, has good softness, can be well attached to the wall of a blood vessel, and has the advantages of good sealing performance, high ductility, tearing resistance and the like. The balloon 2 can be expanded radially outwards relative to the catheter 1 after filling the inner cavity and is attached to the wall of the blood vessel, and the balloon 2 can be retracted radially inwards relative to the catheter 1 after pressure relief of the inner cavity. The sliding ring 3 is slidably connected to the outer circumference of the catheter 1 along the axial direction of the catheter 1, and the sliding ring 3 is positioned at the proximal end of the balloon 2. The barb assembly 4 comprises a barb holder 41 and a spike 42 connected to the barb holder 41, the barb holder 41 and the spike 42 being rigid parts, the spike 42 having a tip portion adapted to scrape thrombus, the proximal end of the barb holder 41 being connected to the slip ring 3 and the distal end of the barb holder 41 being connected to the balloon 2. The barb stent 41 has a collapsed state in which it is collapsed around the outer circumference of the catheter 1 before or after the balloon 2 is not expanded or depressurized, and an expanded state in which the distal end is expanded radially outward with respect to the catheter 1 by the thrust force of the balloon 2 when it is radially expanded.
According to the thrombus taking balloon, the barb support 41 is additionally arranged between the balloon 2 and the sliding ring 3, the spike 42 is arranged on the barb support 41, before the balloon 2 is not expanded, the barb support 41 is folded on the periphery of the catheter 1, the overall outer diameter can be reduced, the trafficability of the catheter 1 is improved, when the balloon 2 is radially expanded, the balloon 2 drives the distal end of the barb support 41 to expand outwards, the proximal end of the barb support 41 drives the sliding ring 3 to slide a certain distance on the catheter 1 distally, when the expanded balloon 2 and the barb support 41 in the expanded state are integrally recovered along with the catheter 1 to the proximal end, the spike 42 on the barb support 41 scrapes thrombus attached to the vessel wall, and compared with the mode that the thrombus is dragged only by the balloon 2 in the prior art, the thrombus taking effect of the thrombus taking balloon can be enhanced.
In some embodiments, as shown in fig. 2, the barb stents 41 are uniformly disposed in plurality around the circumference of the catheter 1, and the spikes 42 are disposed in plurality along the length of the barb stents 41. The proximal ends of the barb brackets 41 are all rotatably connected to the same sliding ring 3, and the distal ends of the barb brackets 41 are all fixed at different positions in the circumferential direction of the proximal end of the balloon 2. The barb support 41 is provided with a plurality of spines 42, and a plurality of spines 42 are also arranged on the barb support 41, so that the scraping area of the spines 42 on the barb assembly 4 can be increased, and the thrombus taking effect of the thrombus taking saccule is further enhanced. In other alternative embodiments, the distal ends of the plurality of barb stents 41 may also be secured to the middle of the balloon 2 or the distal end of the balloon 2.
In some embodiments, as shown in fig. 4, 5 and 6, the barb bracket 41 is provided with a groove 411, the length direction of the groove 411 is set along the length direction of the barb bracket 41, a fixed shaft 43 is connected between a pair of groove side walls of the groove 411, and the axial direction of the fixed shaft 43 is perpendicular to the length direction of the barb bracket 41. The spike 42 is rotatably coupled to the barb holder 41 about the fixed axis 43, and the spike 42 includes a tip portion 421 and a driving portion 422 at both ends in the length direction. The spike 42 has a lying state in which the tip portion 421 is received in the groove 411 of the barb holder 41 during rotation about the fixed axis 43, and a standing state in which the tip portion 421 is disposed at an angle to the longitudinal direction of the barb holder 41 and the tip portion 421 protrudes outward from the side notch of the groove 411 on the barb holder 41. When the plurality of spines 42 are in the standing state, the tip portions 421 of the spines 42 are located at the proximal ends of the spines 42, i.e., the tip portions 421 of the plurality of spines 42 are all directed toward the proximal end of the catheter 1. The arrangement is that when the barb bracket 41 is in the furled state and the plurality of spines 42 are in the lying state, the tip end portions 421 of the plurality of spines 42 do not extend out of the grooves 411 of the barb bracket 41, the spines 42 do not need to occupy extra space on the periphery of the catheter 1, the passing performance of the catheter 1 can be improved, and when the barb bracket 41 is in the unfolding state and the plurality of spines 42 are in the standing state, the tip end portions 421 of the plurality of spines 42 extend outwards from the side edge notches of the grooves 411, and the scraping effect of the spines 42 can be improved. In other alternative embodiments, the groove 411 on the barb bracket 41 may be omitted, at least one end of the fixing shaft 43 protrudes from the side surface of the barb bracket 41, the spike 42 is rotatably connected to the outer side wall of the barb bracket 41 around the fixing shaft 43, the tip portion 421 of the spike 42 is laid down on one side of the barb bracket 41 when the spike 42 is in the laid down state, and the spike 42 is disposed at an angle to the length direction of the barb bracket 41 and the tip portion 421 protrudes outward from the side surface of the barb bracket 41 when the spike 42 is in the standing state.
Further, when the plurality of spikes 42 are in the raised state, the length directions of the plurality of spikes 42 are parallel and all parallel to the length direction of the catheter 1.
In some embodiments, as shown in fig. 4, 5 and 6, the spike 42 is in a flat state when the barb stent 41 is in a collapsed state, the spike 42 is synchronously rotated from a flat state to a raised state when the barb stent 41 is deployed from a collapsed state to a deployed state with radial expansion of the balloon 2, and the spike 42 is synchronously rotated from a raised state to a flat state when the barb stent 41 is collapsed from a deployed state to a collapsed state with decompression retraction of the balloon 2. By means of the arrangement, the unfolding action of the barb support 41 and the standing action of the spike 42 can be synchronously achieved only by means of radial expansion of the balloon 2, a transmission structure does not need to be additionally arranged to drive the spike 42 to rotate around the fixed shaft 43, and the overall structure is simpler. In other alternative embodiments, the rotation of the spike 42 about the fixed shaft 43 may be accomplished by an additional transmission mechanism, i.e., the deployment and retraction of the barb bracket 41 is driven by the balloon 2, and the rotation of the spike 42 is driven by another transmission mechanism not associated with the balloon 2.
In some embodiments, as shown in fig. 4, 5 and 6, a transmission member, specifically, a linkage rod 44 is slidably connected to the bottom of the groove 411 of the barb bracket 41, and the length direction of the linkage rod 44 is the same as the length direction of the barb bracket 41. The linkage rod 44 is slidably connected to the bottom of the groove 411, and one end of the linkage rod 44 extends out from the proximal opening of the groove 411, and the linkage rod 44 is fixedly connected to the plurality of transmission parts 422 of the plurality of spikes 42, so that the linkage rod 44 can drive the plurality of spikes 42 to rotate when sliding.
As shown in fig. 4, 5 and 6, a fixed ring 5 fixed on the periphery of the catheter 1 is arranged at the proximal end of the sliding ring 3, elastic pieces 6 are connected between the proximal ends of the plurality of linkage rods 44 and the fixed ring 5, through holes are arranged on the sliding ring 3, and the elastic pieces 6 penetrate through the through holes on the sliding ring 3 and are connected with the proximal ends of the linkage rods 44. When the barb bracket 41 is in the folded state, the elastic piece 6 is in an elastic compression state, the elastic piece 6 applies pushing force to the linkage rod 44 towards the distal end of the catheter 1, and the plurality of spines 42 are in a lying state under the pushing force of the linkage rod 44. When the barb bracket 41 expands from the folded state to the unfolded state along with the radial expansion of the balloon 2, the proximal end of the barb bracket 41 slides along the axial and distal direction of the catheter 1 along with the sliding ring 3, the elastic piece 6 is stretched from the elastic compressed state to the elastic stretched state, the elastic piece 6 applies a pulling force towards the proximal end of the catheter 1 to the linkage rod 44, and the plurality of spines 42 rotate from the flat lying state to the standing state under the pulling force of the transmission piece. When the barb bracket 41 is folded from the unfolded state to the folded state along with the decompression shrinkage of the balloon 2, the proximal end of the barb bracket 41 slides along with the sliding ring 3 along the axial direction of the catheter 1 to the proximal end, the elastic piece 6 is compressed from the elastic stretching state to the elastic compression state, the elastic piece 6 applies the thrust towards the distal end of the catheter 1 to the linkage rod 44, and the plurality of spines 42 rotate from the standing state to the lying state under the thrust action of the linkage rod 44. The catheter is characterized in that the fixing ring 5 is arranged on the periphery of the catheter 1, the elastic piece 6 with compression elasticity and extension elasticity is connected between the fixing ring 5 and the linkage rod 44, before the balloon 2 is filled, the spike 42 can be kept in a lying state under the elastic action of the elastic piece 6, the spike 42 is prevented from rising to influence the trafficability of the catheter 1, after the balloon 2 is filled, the spike 42 can be kept in a standing state under the elastic action of the elastic piece 6 even if being subjected to larger external resistance, the thrombus scraping capability of the spike 42 is improved, when the balloon 2 is depressurized and retracted, the spike 42 can be automatically restored to the lying state under the elastic action of the elastic piece 6, the integral size of the catheter 1 after the balloon 2 is depressurized is reduced, the catheter 1 is conveniently withdrawn from the body, and the whole structure is simple and easy to realize.
In some embodiments, as shown in fig. 5 and 6, the cross section of the barb holder 41 is circular or square, and the side notches of the groove 411 are located on the side of the barb holder 41 facing away from the catheter 1, and the tip portions 421 of the spikes 42 protrude outward from the side notches of the groove 411 when the spikes 42 are in the standing state. In other alternative embodiments, the side notches of the groove 411 may be located on other sides of the barb support 41, only one side of the groove 411 may be provided with a side notch, or both sides may be provided with a side notch, and when both sides of the groove 411 are provided with a side notch, there are two sets of barbs in the barb support 41, respectively, each set of barbs extending outwardly from the side notch of one of the grooves 411 during rotation.
When the above-mentioned embolectomy balloon in the first embodiment is used, firstly, the catheter 1 containing the balloon 2 in a collapsed state is gently inserted into a blood vessel through a guide wire, after the balloon 2 passes through a stenosis or thrombus site, the balloon 2 is filled to be tightly attached to the vessel wall, along with the expansion of the balloon 2, the barb bracket 41 is unfolded, the spike 42 on the barb bracket 41 is raised after being acted by the tension of the elastic element 6, then the catheter 1 is slowly withdrawn, the thrombus is taken out by the traction of the expanded balloon 2 on the thrombus, and meanwhile, the spike 42 plays a scraping role on the thrombus.
Example two
A embolectomy balloon as shown in fig. 7-9 is different from the one in implementation in that the transmission member is specifically a rack 45 provided with a plurality of tooth grooves, the rack 45 is slidably connected to the bottom of the groove 411, the transmission portion 422 of the spike 42 is provided with a gear, and the rack 45 is in meshed transmission connection with a plurality of gears of the spike 42. According to the thrombus taking balloon, the barb bracket 41 and the rack 45 can move relatively in the unfolding process, when the barb bracket 41 and the rack 45 slide relatively, the rack 45 can drive the spike 42 to rotate through the gear, and the automatic switching of the spike 42 in a lying state and a standing state can be realized by combining the push-pull effect of the elastic piece 6 on the rack 45.
In summary, according to the thrombus removing balloon provided by the invention, the barb bracket 41 is additionally arranged between the balloon 2 and the sliding ring 3, the spike 42 is arranged on the barb bracket 41, the elastic piece 6 is arranged between the spike 42 and the fixed ring 5, before the balloon 2 is not expanded, the barb bracket 41 is folded at the periphery of the catheter 1, the spike 42 is flatly laid in the groove 411 of the barb bracket 41 under the thrust action of the elastic piece 6, the overall outer diameter can be reduced, the passing performance of the catheter 1 is improved, when the balloon 2 is radially expanded, the distal end of the barb bracket 41 is driven by the balloon 2 to be outwards expanded, the sliding ring 3 is driven by the proximal end of the barb bracket 41 to distally slide for a certain distance on the catheter 1, the elastic piece 6 is changed into an elastic tensile state from an elastic compression state, the spike 42 is kept in a standing state under the tensile force of the elastic piece 6, the scraping capability of the spike 42 can be improved, when the expanded balloon 2 and the barbs bracket 41 in the expanded state are retracted along with the catheter 1 in the proximal end, the thrombus is pulled out of the balloon 2 in a pulling manner, and the thrombus removing effect of the thrombus is improved compared with the thrombus removing method in which is carried out by the balloon.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.