Disclosure of Invention
The invention aims at overcoming the defects of the prior art and provides an expansion balloon for a vesicle type string valve.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
The balloon type string valve expanding balloon comprises a central catheter and a plurality of split balloons which are sequentially connected in series along the axis direction of the central catheter, wherein the inside of the split balloons is respectively communicated with the lumen of the central catheter, the central catheter is connected with an external fluid conveying device, and the split balloons are pressurized or depressurized through the external fluid conveying device.
Preferably, the plurality of split balloons are all single-layer balloons, or all multi-layer balloons, or a combination of the single-layer balloons and the multi-layer balloons.
Preferably, the vesicle shape of the split balloon is one or a combination of more than one of spherical shape, elliptic shape, prismatic shape, circular shape and bubbling shape.
Preferably, the external surface of the split balloon is provided with a texture or a plurality of bulges.
Preferably, the plurality of split balloons include a proximal balloon, a distal balloon and a middle balloon, and the diameters of the proximal balloon and the distal balloon after being fully inflated are larger than the diameters of the middle balloon after being fully inflated.
The inner parts of the proximal balloon, the distal balloon and the middle balloon are respectively communicated with the lumen of the central catheter through valve ports, the central catheter is internally provided with a rotary valve, the rotary valve comprises an input end and an output end, the input end is connected with an external fluid conveying device, when the output end is overlapped with the valve ports, the output end is communicated with the valve ports through the rotary valve, and when the output end is not overlapped with the valve ports, the output end is not communicated with the valve ports.
Preferably, when the rotary valve rotates to the first position, the valve ports of the near-end balloon and the far-end balloon are simultaneously communicated with the output end, the valve port of the middle balloon is not communicated with the output end, and when the rotary valve rotates to the second position, the valve port of the middle balloon is communicated with the output end, and the valve ports of the near-end balloon and the far-end balloon are not communicated with the output end.
Preferably, in the fully punched state of the split balloon, the maximum diameter of the distal balloon is 16-32mm, the maximum diameter of the middle balloon is 14-30mm, and the maximum diameter of the proximal balloon is 16-32mm.
Preferably, in the fully pressed state of the split balloon, the internal fluid pressure of the proximal balloon and the distal balloon is 1-3atm, and the internal fluid pressure of the intermediate balloon is 0.1-1atm.
Preferably, the split balloon is formed by a plurality of split small balloons which are annularly arranged around the central catheter, and the inner parts of the split small balloons are respectively connected with an external fluid conveying device through the central catheter.
Compared with the prior art, the balloon type string valve expansion balloon has the advantages of simple manufacturing process and low manufacturing cost, can successfully position the aorta by utilizing the structure, further increases the internal pressure of the balloon to expand deformed or narrow valves, damages calcification of the valves and enables the valves to recover elasticity, pre-expands the primary valves to prepare for replacing artificial valves, simultaneously has extremely high compliance adaptation degree, reduces adverse effects caused by excessive expansion of the balloon and sliding of the balloon, reduces the possibility of occurrence of complications or injuries, is convenient to operate and improves the success rate of operations.
Drawings
FIG. 1 is an elevation view of an inflatable balloon for a vesicular, string-type valve according to a first embodiment of the present invention;
FIG. 2 is a schematic illustration of the positioning of a balloon-type, string-shaped valve dilation balloon in the aorta in accordance with an embodiment of the invention;
FIG. 3 is a schematic view showing an aortic valve state expanded by an expanding balloon for a vesicular string valve according to the first embodiment of the present invention;
FIG. 4 is an enlarged schematic cross-sectional view of a central catheter of an inflatable balloon for a vesicular string valve according to a second embodiment of the present invention;
FIG. 5 is an enlarged schematic cross-sectional view of a central catheter with a rotary valve of a balloon-type, string-shaped valve dilation balloon of a second embodiment of the present invention in a first position;
fig. 6 is an enlarged schematic cross-sectional view of a central catheter with a rotary valve of a balloon-type, string-shaped valve dilation balloon of a second embodiment of the present invention in a second position.
FIG. 7 is a schematic view of a split balloon of a balloon-type string valve dilation balloon according to a third embodiment of the present invention in double layers;
FIG. 8 is an enlarged schematic cross-sectional view of a middle balloon of a balloon-type string-type valve dilation balloon according to a fourth embodiment of the present invention;
The device comprises a distal balloon 101, a distal inner balloon 102, an intermediate balloon 102, a split balloon 102, a proximal balloon 103, a central catheter 104, a proximal valve port 104a, a distal valve port 104b, a middle valve port 104c, a capillary tube 105, a left ventricular outflow tract 106, a aortic valve 107, a valve leaflet 108, a valve 109, an aorta 110, an inner tube 110, a proximal opening 110, a distal opening 110b, a middle opening 110c, a tube cavity 111, and a rotary valve 112.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.
Embodiment one:
As shown in fig. 1-3, the balloon type string-shaped valve expansion balloon of the embodiment comprises a catheter and split balloons which are sequentially arranged along the catheter, wherein the separate balloons are not communicated with each other and have independent inner cavities, the split balloons can be directly made of different materials, the material compliance requirements of different positions are met, and the process is simplified relative to that of an integral balloon.
Specifically, the split balloon includes a proximal balloon 103, a middle balloon 102 and a distal balloon 101, and the proximal balloon 103 and the distal balloon 101 are made of a non-compliant material, which may be PET, polytetrafluoroethylene, polyimide, a high molecular polymer or a fiber material, or may be treated with a compliant or semi-compliant material by an electron beam, chemical or other crosslinking method to make the balloon relatively non-compliant. The intermediate balloon 102 is made using a semi-compliant material, which may be nylon, resin, vinyl, PVC, polyethylene, polyurethane, polyether amide, olefin, or the like. Likewise, non-compliant materials may also be used to weaken the structure of the material by electron beam, chemical treatment, or other process, thereby imparting relative semi-compliance.
The proximal balloon 103, the middle balloon 102 and the distal balloon 101 are respectively connected in series on the central catheter 104, the balloon is in a prismatic shape and is communicated with the official cavity of the central catheter 104 through a capillary 105, the central catheter 104 is connected with an external fluid conveying device, the plurality of split balloons are pressurized or depressurized through the external fluid conveying device, and the fluid control device is provided with a pressure gauge and a control valve and is used for measuring the pressure of the inner cavity of the balloon so as to control the expansion of the balloon. Under the state of full inflation, the diameters of the proximal balloon 103 and the distal balloon 101 are larger than those of the middle balloon 102, by virtue of the two large ends, the middle small structure can conveniently fix the balloons at the positions of the valves, the possibility of the whole balloon sliding in a shifting way is reduced, meanwhile, different balloons control fluid delivery by virtue of different delivery pipes, the possibility of valve tearing caused by balloon rupture and over expansion is greatly reduced by the fact that the inflation and the contraction of the different balloons are not interfered with each other, so that the speed, the success rate and the safety of operation are improved, the maximum diameter of the distal balloon 101 is 16-32mm, the maximum diameter of the middle balloon 102 is 14-30mm, the maximum diameter of the proximal balloon 103 is 16-32mm, the internal fluid pressure of the proximal balloon 103 and the distal balloon 101 is 1-3atm, the internal fluid pressure of the middle balloon 102 is 0.1-1atm, and the balloon string type valve under the data has the highest use adaptation degree.
Preferably, the number of the split balloons is more than three, and the shapes of the vesicles of the split balloons are one or more of spherical, elliptic, prismatic circular and bubbling shapes, and the split balloons are matched with graded pressure control to obtain various string structures.
Preferably, the surface of the balloon is textured or roughened, and the texture can be plain, twill, reticulate or threads, or can be thorn-shaped or hemispherical bulges which are distributed so as to increase the surface friction force of the balloon after the balloon is inflated, maintain the position of the whole balloon when the valve is expanded, and reduce the possibility of sliding of the balloon after the balloon is positioned at the aorta 109 due to heart beating or blood pressure. Meanwhile, the surface bulges are easier to concentrate stress, and compared with the smooth surface of the balloon, the calcification and rupture of the valve are easier even under low pressure.
Preferably, a visualization material is added to the balloon material to allow visualization of balloon inflation by the visualization device, and preferably, the balloon outer surface may be coated with some of the drugs required during the procedure, e.g., taxol-based drugs may be used to eliminate calcification of local valve deposits and promote calcification rupture.
Preferably, the intermediate balloon 102 is bonded to the distal balloon 101 and the proximal balloon 103 at both ends thereof, respectively, by thermal bonding, solvent bonding, or by using an adhesive.
Taking the aorta 109 as an example, the implementation of the balloon-expanded aortic valve 107 will be described in detail with reference to fig. 2 and 3.
Fig. 2 shows the balloon being delivered to the aorta 109 via a delivery device, with the distal balloon 101 positioned in the left ventricular outflow tract 106 and the intermediate balloon 102 positioned in the aortic valve 107 using a fluoroscopic imaging technique. After the balloon is positioned at the valve, fluid delivery to the distal balloon 101 and the proximal balloon 103 by the external fluid delivery device is started to the balloon internal pressure of about 0.1-0.5atm, at which point the balloon internal pressure is slightly higher than the external pressure. By pushing or pulling back the central catheter 104, in conjunction with the pressure build-up or deflation within the balloon, the intermediate balloon 102 is stabilized as much as possible at the aortic valve 107, so that the entire balloon as a whole is in a relatively ideal position. After the positioning is determined, the pressure in the distal balloon 101 and the proximal balloon 103 is further increased to 1-3atm by an external fluid delivery device to allow the balloon to fully expand and the balloon outer wall to rest against the vessel wall. When its diameter is slightly larger than the aorta 109, the entire balloon will not slide away from the relatively narrow aortic valve 107 even if it slides under blood pressure. But also the expansion thereof is limited by the structure of the non-compliant material, avoiding the occurrence of excessive expansion.
Fig. 3 illustrates that after balloon positioning, the pressure in the intermediate balloon 102 is increased on the basis of fig. 2, such that the intermediate balloon 102 expands and pushes the leaflets 108 outward, causing calcification dehiscence. The pressure in the intermediate balloon 102 is gradually increased until the calcified portion of the leaflet 108 is sufficiently destroyed. In a prosthetic valve implantation procedure, to determine the diameter of the patient's aortic valve 107 and to determine how large a prosthetic valve is needed and the inflation pressure required to fully expand the prosthetic valve, the pressure in the intermediate balloon 102 may be further increased to fully expand until the balloon waist is fully seated against the aortic valve 107. When the two are fully abutted, the middle balloon 102 is subjected to imaging record, the diameter of the aortic valve 107 is estimated from the expansion size of the middle balloon and the internal pressure of the middle balloon, and a prosthetic valve with corresponding size is selected.
The balloon type string valve expansion balloon of the embodiment has simple manufacturing process and low manufacturing cost, can successfully position the aorta 109 by utilizing the structure of the balloon type string valve expansion balloon, further increases the internal pressure of the balloon to expand deformed or narrow valves, damages calcification of the valves and enables the valves to recover elasticity, pre-expands the original valves to prepare for replacement of the artificial valves, has extremely high compliance adaptation degree, reduces adverse effects caused by excessive expansion of the balloon and sliding of the balloon, reduces the possibility of occurrence of complications or injuries, is convenient to operate and improves the success rate of operations.
Embodiment two:
The balloon-type string-shaped valve dilation balloon of this embodiment differs from that of the first embodiment in that:
As shown in fig. 4-6, the internal structure of the central catheter 104 of the present embodiment adopts a rotary valve structure, the insides of the proximal balloon 103, the distal balloon 101 and the intermediate balloon 102 are respectively communicated with the lumen 111 of the central catheter 104 through valve ports, the rotary valve 112 comprises an input end and an output end, the input end is connected with an external fluid delivery device, when the output end coincides with the valve ports, the output end is communicated with the valve ports, and when the output end does not coincide with the valve ports, the output end is not communicated with the valve ports through the rotary valve 112. That is, the inner tube 110 at the output end of the rotary valve 112 is rotated to align each valve port with the valve port on the central catheter 104, and then the fluid in the lumen 111 is input or pumped out by the control delivery device to achieve the purpose of controlling the expansion or contraction of the balloon.
As shown in fig. 4, all ports of the central conduit 104 are closed.
Rotating the inner tube 110 aligns the proximal and distal openings 110a, 110b with the proximal and distal ports 104a, 104b on the central catheter 104, as shown in fig. 5, i.e., when the rotary valve 112 is rotated to the first position, then fluid delivery means is used to deliver fluid to the lumen 111 to increase pressure, causing the fluid within the lumen 111 to enter the distal and proximal balloons 101, 103, and the balloon begins to expand.
After the distal balloon 101 and proximal balloon 103 have been fully inflated and against the vessel wall, the inner tube 110 is further rotated, as shown in FIG. 6, by rotating the rotary valve 112 to a second position, aligning the intermediate opening 110c on the inner tube 110 with the intermediate valve port 104c on the central catheter 104, while the proximal and distal valve ports 104a, 104b on the central catheter 104 are in a closed position, and using a fluid delivery device to deliver fluid into the lumen 111 to increase the pressure, causing fluid within the lumen 111 to enter the intermediate balloon 102, to expand the intermediate balloon 102 to expand the valve. After the valve expansion is completed, the fluid in the lumen 111 is pumped out to enable the middle balloon 102 to contract until the pressure in the balloon is reduced to 0atm, then the inner tube 110 is rotated reversely to the state of fig. 5, the fluid in the lumen 111 is continuously pumped out to enable the distal balloon 101 and the proximal balloon 103 to contract, when the pressure in the balloon is restored to 0atm, the inner tube 110 is rotated to the state of fig. 4 to enable all valve ports to be closed, and finally the balloon and the catheter are withdrawn. This embodiment has the advantage of avoiding the simultaneous constraint of the plurality of capillaries 105 within the central catheter 104, resulting in extrusion of each other, simplifying the assembly structure of the central catheter 104, while the inflation and deflation of the distal balloon 101 and the proximal balloon 103 are more synchronized.
Other structures refer to embodiment one.
Embodiment III:
The balloon-type string-shaped valve dilation balloon of this embodiment differs from that of the first embodiment in that:
As shown in fig. 7, the split balloon of the present embodiment forms a double-layered balloon by nesting additional balloons within the balloon. Meanwhile, the inner and outer double-layer balloons are respectively provided with independent capillaries 105 for partial pressure control, and taking the distal balloon 101 as an example, a distal inner balloon 101a is nested inside the inner double-layer balloon, and the inner pressure of the distal balloon 101 and the inner distal balloon 101a is respectively controlled through different capillaries 105. The inner balloon has a semi-compliant shape with a maximum diameter slightly larger than the maximum diameter of the outer balloon under full inflation, such as at a pressure of 1-3 atm. Compared with the first embodiment, increasing the number of layers of the balloon can improve the pressure resistance inside a single balloon and reduce the possibility of balloon explosion, increasing the pressure resistance of the middle balloon 102 can further improve the effect of fully expanding the valve, and meanwhile, the multi-balloon layer can also prevent broken calcified fragments from puncturing the whole balloon. The partial pressure control can more accurately control the expansion size and speed of the balloon, avoid the instantaneous over expansion of the balloon from damaging the vessel wall, and ensure more uniform pressure distribution on the surface of the balloon. Similarly, in addition to the double-layer balloon, the implementation mode of embedding the multi-layer balloon can be adopted in actual application, so that the regulation and control of the internal pressure are more refined and accurate.
Other structures refer to embodiment one.
Embodiment four:
The balloon-type string-shaped valve dilation balloon of this embodiment differs from that of the first embodiment in that:
As shown in fig. 8, the cross-sectional structure of the valve of a patient is generally not a regular circle, and particularly a patient with severe calcification, due to the different areas and degrees of calcification of the valve, the valve forms irregular hard protrusions when being expanded and pressed around the valve annulus by the balloon, which have a certain pressure on the surface of the balloon, and the limited compliance of the balloon can prevent the balloon from forming an effective fit at the relatively lightly calcified part of the valve, which in turn leads to insufficient expansion. Taking the middle balloon 102 as an example, a plurality of split small balloons 102a are arranged in an annular mode around a central catheter 104, and each small balloon is respectively provided with a capillary 105 which is communicated with a fluid conveying device so as to respectively control the expansion and the contraction of each small balloon. The embodiment adopts the mode of combining multiple balloons in the same area to solve the problem of the fit of the balloons during the expansion of the balloons for different patients,
Other structures refer to embodiment one.
The specific embodiments described herein are offered by way of example only to illustrate the spirit of the invention. Those skilled in the art may make various modifications or additions to the described embodiments or substitutions thereof without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.