Background
Heart valves are the basic structure of the heart, and they may suffer from the diseases of insufficiency (regurgitation), valve stenosis, etc. due to congenital or acquired inflammation, etc., and may endanger life when serious. With the progressive rise in incidence of degenerative heart valve disease, left ventricular outflow tract obstruction will occur at the end of the disease, resulting in decreased cardiac stroke volume, decreased exercise capacity, heart failure, death from cardiovascular causes, and the like. The incidence of valvular stenosis increases with age, with the incidence being only about 0.2% for the 50-59 year old population, and 9.8% for the 80-90 year old population.
The tricuspid valve is a multiple area of heart valve diseases, when the tricuspid valve is calcified, the tricuspid valve can not be well closed, gaps can be formed between the tricuspid valve, upper atrium is caused to leak and press, and blood pressure can not reach expected blood vessel pressure.
While valvuloplasty provides only modest hemodynamic improvement, and the incidence of restenosis is high, long-term survival after surgery is not significantly different from the natural history of valvular stenosis, the focus of currently treating valvular stenosis has been shifted from balloon valvuloplasty to transcatheter valve replacement, but there are still a number of problems at present, including valve durability, retention of coronary artery (coronary) access, formation of valve She Xieshuan, etc., balloon dilation is an important link in surgery, and how to improve the therapeutic effect of valve balloon dilation is the direction of our study.
Disclosure of Invention
The invention aims to provide a shock wave balloon dilation catheter for a tricuspid valve opening, which aims to solve the technical problems of realizing treatment of calcification of a heart valve, simultaneously keeping a certain amount of blood flow in the treatment process, ensuring the safety of operation and improving the treatment effect.
In order to solve the problems, the invention adopts the following technical scheme: a shock wave saccule dilating catheter for tricuspid valve opening sequentially comprises a tip, a saccule, a dilating catheter and a handle seat from the distal end to the proximal end,
the outer wall of the balloon is provided with three arc-shaped protruding parts distributed along the circumferential direction of the balloon, the inner cavities of the arc-shaped protruding parts are communicated with the inner cavity of the balloon to form a whole, and arc-shaped concave parts are arranged between two adjacent arc-shaped protruding parts to form a blood passing channel;
the expanding catheter is internally provided with a guide wire cavity and a liquid passing cavity, the proximal end of the expanding catheter is connected with the handle seat, the distal end of the expanding catheter penetrates through the inner cavity of the balloon and extends out of the distal end of the balloon to be connected with the tip, the expanding catheter is coaxially arranged with the balloon, the proximal end of the balloon is connected with the outer wall of the expanding catheter, the distal end of the balloon is in sealing connection with the tip, and the liquid passing cavity is communicated with the inner cavity of the balloon;
a plurality of groups of shock wave generators with different transmitting directions are arranged on the part of the pipe body of the expansion pipe, which is positioned in the saccule;
the handle seat comprises a first interface and a second interface, two channels which are respectively connected with the first interface and the second interface are arranged in the handle seat, the first interface is communicated with the guide wire cavity through one of the channels, the second interface is communicated with the liquid passing cavity through the other channel, the handle seat further comprises an electrifying connector, and the shock wave generator is electrically connected with the electrifying connector through a wire.
Further, the arc-shaped concave part is provided with a reinforcing rib, and the reinforcing rib is arranged along the axial direction of the balloon.
Further, the reinforcing rib is provided at the center of the arc-shaped recess.
Further, the arc-shaped protruding portion is arc-shaped.
Further, the shock wave generator comprises a plurality of electrode rings, insulating sleeves and metal sleeves, the quantity of the insulating sleeves is the same as that of the electrode rings, copper exposure areas are formed in the conducting wires, the metal sleeves are sleeved on the copper exposure areas of the conducting wires, the metal sleeves are fixed on the outer wall of the expansion conduit, the insulating sleeves are sleeved on the pipe body of the expansion conduit outside the metal sleeves so as to cover the metal sleeves, the electrode rings are sleeved outside the insulating sleeves, the electrode rings and the metal sleeves are fixed on the outer wall of the expansion conduit through insulating glue, insulating sleeve through holes exposing the metal sleeves are formed in the positions of the insulating sleeves located on the metal sleeves, and electrode ring discharge through holes are formed in the positions, opposite to the positions of the electrode rings and the insulating sleeve through holes.
Further, two electrode ring discharge through holes are formed in the electrode ring and symmetrically arranged on the electrode ring, and correspondingly, the insulating sleeve through holes are opposite to the electrode ring discharge through holes.
Further, the electrode ring discharge through holes on two adjacent electrode rings are arranged in a staggered manner.
Further, the expansion catheter comprises an inner tube and an outer tube, the aperture of the outer tube is larger than the outer diameter of the inner tube, the outer tube is sleeved outside the inner tube, the outer tube and the inner tube are coaxially arranged, a liquid passing cavity is arranged between the inner tube and the outer tube, a guide wire cavity is formed by the tube cavity of the inner tube, the far end of the inner tube extends out of the far end of the outer tube, penetrates through the inner cavity of the saccule and then is connected and fixed with the tip, and the far end of the outer tube is connected with the near end of the saccule.
Compared with the prior art, the invention has the advantages that the three arc-shaped protruding parts are arranged on the periphery of the balloon, the arc-shaped concave parts are arranged between the two adjacent arc-shaped protruding parts, so that after the balloon is filled, the arc-shaped concave parts form a blood flow passage, a certain amount of blood flow can be ensured to pass through during treatment, the blood flow passage is prevented from being blocked completely, at least one group of shock wave generators are arranged on the part of the tube body of the expansion catheter penetrating through the inner cavity of the balloon, and calcified parts are smashed through the shock wave generators after the balloon is filled, so that the safety of operation is ensured, and the treatment effect is improved.
Detailed Description
The invention is described in further detail below with reference to the drawings and examples.
In the present invention, distal refers to the end distal from the operator; proximal refers to the end that is proximal to the operator.
As shown in fig. 1, 2 and 3, the invention discloses a shock wave balloon dilation catheter for tricuspid valve opening, which sequentially comprises a tip 1, a balloon 2, a dilation catheter 3 and a handle seat 4 from the distal end to the proximal end, wherein:
the outer wall of the balloon 2 is provided with three arc-shaped protruding parts 23 distributed along the circumferential direction of the balloon 2, the inner cavities of the arc-shaped protruding parts 23 are communicated with the inner cavity of the balloon 2 to form a whole, an arc-shaped concave part 22 is arranged between two adjacent arc-shaped protruding parts 23 to form a blood circulation channel, and the arc-shaped protruding parts 23 extend along the axial direction of the balloon 2;
the dilating catheter 3 is provided with a guide wire cavity 31 and a liquid passing cavity 32, the guide wire cavity 31 is arranged on the axis of the dilating catheter 3, the liquid passing cavity 32 surrounds the periphery of the guide wire cavity 31, the proximal end of the dilating catheter 3 is connected with the handle seat 4, the distal end of the dilating catheter 3 penetrates through the inner cavity of the balloon 2 and extends out of the distal end of the balloon 2 to be connected with the tip 1, the dilating catheter 3 is coaxially arranged with the balloon 2, the proximal end of the balloon 2 is connected with the outer wall of the dilating catheter 3, the distal end of the balloon 2 is connected with the tip 1, the liquid passing cavity 32 is communicated with the inner cavity of the balloon 2 so as to fill the balloon 2 through the liquid passing cavity 32, and after the balloon 2 is filled, a certain interval is reserved between the arc-shaped concave part 22 and the tricuspid valve opening, so that blood flow can still pass through the blood passing channel;
the tip 1 is provided with a through cavity, the guide wire cavity 31 is communicated with the through cavity of the tip 1, the tip 1 is composed of a cone and a cylinder, the cylinder is fixedly connected with the distal end of the expansion catheter 3, and the cone is arranged at the distal end of the cylinder;
a plurality of groups of shock wave generators 5 with different transmitting directions are arranged on the part of the tube body of the expansion catheter 3 positioned in the balloon 2 so as to realize the generation of shock wave energy in all directions towards the periphery of the balloon 2;
the handle seat 4 comprises a first interface 41 and a second interface 42, two channels respectively connected with the first interface 41 and the second interface 42 are arranged in the handle seat 4, the first interface 41 is communicated with the guide wire cavity 31 through one channel, the second interface 42 is communicated with the liquid passing cavity 32 through the other channel, the handle seat 4 further comprises an electrifying connector 43, and the shock wave generator 5 is electrically connected with the electrifying connector 43 through a wire 6.
With the above structure, it is realized that the blood flow passage is formed by the natural shape of the balloon without being separately arranged, the blood flow flows through the concave part (namely, the arc concave part 22) of the balloon, and the arc convex part 23 is used for fixing the balloon and the opening wall of the tricuspid valve.
As shown in fig. 1, the overall shape of the balloon 2 of the present invention is olive-shaped.
As shown in fig. 2, the arc-shaped concave portion 22 is provided with a reinforcing rib 21, and the reinforcing rib 21 is arranged along the axial direction of the balloon 2; the reinforcing ribs 21 may be fixed by gluing or by braiding the reinforcing ribs 21 in the balloon body of the balloon 2 during the braiding of the balloon, preferably the reinforcing ribs 21 are arranged in the centre of the arc-shaped recesses 22, in the present invention one reinforcing rib 21 in each arc-shaped recess 22. Conventional balloons will equivalently expand outwardly during inflation. The provision of stiffening ribs can limit the tendency of the balloon wall to expand at the rib locations, enabling the convex and concave outer walls of the balloon to be realized.
As shown in fig. 2, the arc-shaped protruding portion 23 is preferably in a circular arc shape, the shapes of the three arc-shaped protruding portions 23 are the same, and the arc-shaped recessed portions are uniformly transited and are connected with the adjacent arc-shaped protruding portions 23 into a whole.
As shown in fig. 3 to 5, the shock wave generator 5 comprises a plurality of electrode rings 51, insulating sleeves 52 and metal sleeves 53, the number of the insulating sleeves 52 is the same as that of the electrode rings 51, copper exposure areas are arranged on the lead 6, the metal sleeves 53 are sleeved on the copper exposure areas of the lead 6, the metal sleeves 53 are fixed on the outer wall of the expanding catheter 3 through insulating glue, the insulating sleeves 52 are sleeved on a pipe body of the expanding catheter 3 outside the metal sleeves 53 so as to cover the metal sleeves 53, the electrode rings 51 are sleeved outside the insulating sleeves 52 and are fixed through insulating glue 54, insulating sleeve through holes 521 exposing the metal sleeves 53 are formed in the positions of the insulating sleeves 52 located on the metal sleeves 53, electrode ring discharge through holes 511 are formed in positions, opposite to the positions of the insulating sleeve through holes 521, of the electrode rings 51 are symmetrically arranged on the electrode rings 51, and correspondingly, the insulating sleeve through holes 521 are also formed in two positions opposite to the electrode ring discharge through holes 511.
Specifically, the lead 6 includes a positive electrode lead 61, a negative electrode lead 62, and a connecting lead 63, both ends of the connecting lead 63 are provided with exposed copper areas, the connecting lead 63 is disposed between two adjacent electrode rings 51, the exposed copper areas of the connecting lead 63 are respectively opposite to one of the electrode ring discharge through holes 511, the exposed copper areas are sleeved with metal sleeves 53, the distal end of the positive electrode lead 61 extends to the nearest electrode ring 51 along the expansion catheter 3, the distal end of the positive electrode lead 61 is provided with exposed copper areas, the exposed copper areas are sleeved with metal sleeves 53, the exposed copper areas of the positive electrode lead 61 are opposite to one electrode ring discharge through hole 511 of the nearest electrode ring 51, the proximal end of the positive electrode lead 61 extends to be electrically connected with the positive electrode of the power-on connector 43, the distal end of the negative electrode lead 61 is also provided with exposed copper areas, the distal end of the negative electrode lead 61 is opposite to one of the electrode ring discharge through holes 511 of the farthest electrode ring 51, and the proximal end of the negative electrode lead 61 extends along the expansion catheter 3 to be electrically connected with the negative electrode of the power-on connector 43.
Taking one electrode ring 51 as an example, when the proximal end of the connection wire 63 at the distal end of the electrode ring 51 is opposite to one electrode ring discharge through hole 511 on the electrode ring 51, the distal end of the connection wire 63 at the proximal end of the electrode ring 51 is opposite to the other electrode ring discharge through hole 511, that is, two copper-exposed areas of the connection wire 63 respectively correspond to one electrode ring discharge through hole 511 of the two electrode rings 51.
In the present invention, the electrode ring discharge through holes 511 on the adjacent two electrode rings 51 are arranged in a staggered manner.
As shown in fig. 2, the shock wave generator 5 is disposed at the center of the balloon body 23.
As shown in fig. 1, the dilating catheter 3 comprises an inner tube 33 and an outer tube 34, the aperture of the outer tube 34 is larger than the outer diameter of the inner tube 33, the outer tube 34 is sleeved outside the inner tube 33, the outer tube 34 and the inner tube 33 are coaxially arranged, the liquid passing cavity 32 is arranged between the inner tube 33 and the outer tube 34, the guide wire cavity 31 is formed by the cavity of the inner tube 33, the distal end of the inner tube 33 extends out of the distal end of the outer tube 34, passes through the inner cavity of the balloon 2 and then is connected and fixed with the tip 1, the distal end of the outer tube 34 is connected with the proximal end of the balloon 2, and the shock wave generator 5 is arranged on the part of the tube body of the inner tube 33, which is positioned on the balloon 2.
In the present invention, the electrode ring 51 is made of a conductive metal material, preferably 304 stainless steel, the insulating sleeve 52 is made of an insulating material such as PI (polyimide) material, the metal sleeve 53 is made of a conductive metal material, preferably 304 stainless steel, and the insulating glue 54 is an insulating UV glue, for example a UV glue of the type of lota 349.
When the invention is used, the invention is placed at the tricuspid valve position, after liquid is introduced, the sacculus body is filled, the arc-shaped protruding part 23 expands the tricuspid valve, and the tricuspid valve wall and the arc-shaped recessed part 22 are not completely blocked, so that a blood flow passage formed by the arc-shaped recessed part 22 can supply blood to flow, the shock wave generator 5 is triggered, and the shock wave energy is released to the periphery, so that calcified parts are broken, thereby recovering the physiological function of the tricuspid valve, realizing the repair of the tricuspid valve without placing an artificial valve, simultaneously not completely blocking blood flow in the repair process, and improving the safety of operation.