WO2023125938A1

WO2023125938A1 - Guide assembly and device and system having same

Info

Publication number: WO2023125938A1
Application number: PCT/CN2022/143962
Authority: WO
Inventors: 曾建锋; 李阳; 庄镇平
Original assignee: 杭州诺沁医疗器械有限公司
Priority date: 2021-12-31
Filing date: 2022-12-30
Publication date: 2023-07-06
Also published as: CN116407730A

Abstract

A guide assembly for guiding a needle body (2), comprising a body (1). A first cavity (101) allowing a needle body (2) to pass through is provided in the body (1); a needle advancement surface (104) is provided on a side wall of the body (1); and the distal end of the first cavity (101) is provided with a needle outlet (103) on the needle advancement surface (104). The guide assembly further comprises an anti-skid array, the anti-skid array comprising a plurality of anti-skid structures, and the anti-skid structures protruding out of the needle advancement surface (104). By means of the anti-skid array, the coefficient of static friction between the guide assembly and a tissue wall can be improved, and more importantly, the impact force of the blood flow is reduced by means of the plurality of anti-skid structures arranged in an array, so that the abutting stability of the guide assembly on a tissue wall is improved, and the problem is solved that a needle body (2), due to tissue movement or blood flow impact, is liable to deviate from an area to undergo treatment.

Description

A guiding component and device and system with the component

technical field

The invention relates to the technical field of medical instruments, in particular to a guiding component, a device and a system with the component.

Background technique

The prior art (US5558673A and US5370675A) discloses a guide assembly for guiding the needle exit angle and direction of the puncture needle. The surface of the guide assembly is attached to the tissue wall, and then the needle exit angle is adjusted, and after the needle exit angle is determined, the needle exits for puncture. In the above solution, the needle exit surface of the guide assembly needs to be kept in close contact with the tissue wall during the adjustment of the needle exit angle, the needle exit, and the treatment. When this guide assembly is applied to the treatment in the heart chamber, since the heart is always in a state of rapid beating, and the heart includes two states of cardiac expansion and systole in each beating cycle, the guide assembly cannot keep close The state of leaning against the inner wall of the heart; and in the process of the guide assembly being attached to the inner wall of the heart, it will be subjected to a high-speed impact force from the blood flow inside the heart, and the impact force will easily cause the guide assembly to break away from the tissue wall.

If the guide assembly is separated from the tissue wall before the needle is pulled out, the operator can only reselect the point, resulting in increased operation time and low operation efficiency; Move and increase the stroke of the needle body correspondingly, which is not only unfavorable for the progress of the treatment, but may even puncture the heart in severe cases, endangering the life safety of the patient.

Contents of the invention

In order to overcome at least one defect described in the above-mentioned prior art, one of the objects of the present invention is to provide a guide assembly, which can not only improve the guide The coefficient of static friction between the component and the tissue wall, and more importantly, the multiple anti-slip structures arranged in an array can reduce the impact of blood flow, thereby improving the stability of the guide component against the tissue wall, thereby solving the problem of needles that are easy to cause Problems with tissue movement or impact of blood flow away from the area to be treated.

Another object of the present invention is to provide an ablation device for ablation of myocardial tissue by puncturing endocardium through the guide device.

Another object of the present invention is to provide an ablation system to ablate myocardial tissue by puncturing the endocardium through the guiding device.

Another object of the present invention is to provide an injection device for injecting a therapeutic agent into myocardial tissue by puncturing the endocardium through the guiding device.

Another object of the present invention is to provide an injection system for injecting a therapeutic agent into myocardial tissue by puncturing the endocardium through the guiding device.

The technical scheme that the present invention adopts for solving its problem is:

A guide assembly, used to guide a needle body, includes a body, the body has a first cavity for the needle body to pass through, the side wall of the body is provided with a needle exit surface, and the distal end of the first cavity is The end is provided with a needle exit on the needle exit surface, and the feature is that the guide assembly also includes an anti-slip array, and the anti-slip array includes a plurality of anti-slip structures, and the anti-slip structures protrude from the needle exit surface.

According to yet another aspect of the embodiments of the present invention, the present application provides an ablation device, including a delivery assembly, an ablation assembly, and the above-mentioned guide assembly;

The delivery assembly includes a catheter having a hollow lumen, the guide assembly is disposed at a distal end of the catheter;

The ablation assembly includes a needle, and the needle is movably installed in the first cavity of the guide assembly. Thus, the delivery assembly is inserted into the heart through the catheter, and after the needle passes through the delivery assembly through the guide assembly, it enters the myocardial tissue by puncturing the endocardium, so as to perform ablation on the myocardial tissue.

According to yet another aspect of the embodiments of the present invention, the present application provides an ablation system, including an ablation energy generating device and the above-mentioned ablation device;

The ablation energy generating device is connected to the ablation device, and the ablation energy generating device is configured to provide energy for the ablation device to enable the needle body to perform tissue ablation.

According to yet another aspect of the embodiments of the present invention, the present application provides an injection device, including a delivery assembly and an injection assembly, the delivery assembly includes a catheter and the above-mentioned guide assembly, the proximal end of the guide assembly is connected to the catheter remote connections; and

The injection assembly includes an injection needle movably disposed in the first cavity of the guide assembly.

According to still another aspect of the embodiments of the present invention, the present application provides an injection system, including the above-mentioned injection device, and the injection device further includes at least one injection part, and the injection part communicates with the injection needle.

In summary, compared with the prior art, the embodiment of the present application has at least the following technical effects:

There are multiple anti-slip structures protruding from the needle exit surface of the guide assembly, and the multiple anti-slip structures form an array, which can not only improve the static friction coefficient between the guide assembly and the tissue wall, but also improve the static friction between the two , to prevent detachment from the needle exit surface of the guide assembly due to tissue movement; and because multiple anti-slip structures form an array, when high-speed flowing blood passes through the side of the array, it can be dispersed by the multiple anti-slip structures arranged in the array, and the high-speed A stream of blood is dispersed into a number of slow-flowing thin streams, and the flow velocity is further reduced due to the mutual flow field interference, so as to avoid the impact force of the blood stream from causing the needle surface to move or disengage, thereby improving the guide assembly in the The abutment stability on the tissue wall further solves the problem that the needle body deviates from the predetermined treatment area.

Description of drawings

Fig. 1 is a schematic diagram of assembly between a body and a guide wire in some embodiments;

Fig. 2 is an exploded schematic view between the slider and the body;

Fig. 3 is a structural schematic diagram of a slider;

Fig. 4 is a schematic diagram of the assembly of the sliding part on the body when the tooth-shaped part is extended;

Fig. 5 is a schematic diagram of the assembly of the sliding part on the body when the toothed part is retracted;

Fig. 6 is a schematic diagram of the structure when the toothed part protrudes from the fixed part;

Fig. 7 is a structural schematic diagram of the retraction of the toothed part into the fixed part;

Fig. 8 is a schematic structural view of the body in the bending adjustment sheath;

Fig. 9 is a partially enlarged view of part A in Fig. 8;

Fig. 10 is a partially enlarged view of part B in Fig. 8;

Fig. 11 is a schematic structural view of the body when the needle outlet surface is coated with a non-slip coating in some embodiments;

Fig. 12 is a schematic structural view of some embodiments when protrusions are provided on the body;

Fig. 13 is a partially enlarged view of part C in Fig. 14;

Fig. 14 is a schematic structural diagram of the ablation device described in some embodiments;

Fig. 15 is a schematic structural diagram of the ablation system described in some embodiments;

Figure 16 is a schematic diagram of the ablation needle penetrating into the target tissue for ablation treatment

Fig. 17 is a schematic structural view of the injection system described in some embodiments.

Among them, the reference signs have the following meanings:

1. Body; 101, first cavity; 1011, axial extension cavity; 1012, arc transition cavity; 1013, inclined cavity; 102, second cavity; 103, needle outlet; 104, needle surface; 105, perforation ; 106, channel; 107, distal end; 108, tube cover; 2, needle body; 3, guide wire; 4, catheter; 5, pigtail catheter; 7, sliding part; 701, slider; 7011, threading hole; 702, fixing part; 703, spring; 8, driving part; 9, anti-skid coating; Sheath; 12, ablation component; 13, ablation energy generating device; 14, perfusion device; 15, handle; 16, injection part.

Detailed ways

For better understanding and implementation, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", The orientation or positional relationship indicated by "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying the referred device or positional relationship. Elements must have certain orientations, be constructed and operate in certain orientations, and therefore should not be construed as limitations on the invention.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention.

Referring to FIG. 1 to FIG. 2 , some embodiments disclose a guide assembly, which includes a body 1 having a first cavity 101 for the needle body 2 to pass through. The side wall of the body 1 is provided with a needle outlet surface 104, and the distal end of the first cavity 101 is provided with a needle outlet 103 on the needle outlet surface 104. The guide assembly also includes an anti-skid array, which includes a plurality of anti-skid structures, and the anti-skid structure is convex. Out of the needle surface 104.

When the needle-exit surface 104 of the guide assembly abuts against the tissue wall, the anti-slip array abuts against the tissue wall. Each anti-slip structure can improve the static friction coefficient between the needle exit surface 104 and the tissue wall. In the process of adhering, it is separated from the tissue wall due to tissue movement; and because multiple anti-slip structures form an array, when the high-speed flowing blood passes through the side of the array, it can be dispersed by the multiple anti-slip structures arranged in the array, and the high-speed flow The blood flow is dispersed into several slow-flowing thin streams, and the flow velocity is further reduced due to the mutual flow field interference, thereby improving the abutment stability between the guiding component and the target tissue wall, and reducing the reselection of the puncture point The number of times, thereby improving the efficiency of puncture treatment.

Therefore, the guide assembly provided by the embodiments of the present application is especially suitable for the treatment in the heart chamber, for example, transcatheter endocardial ablation or transcatheter endocardial injection.

The first cavity 101 passes through the proximal end and the distal end of the main body 1 , and generally extends along the axial direction of the main body 1 . Further, the proximal opening direction of the first cavity 101 is the same as that of the body 1 , and the distal opening direction of the first cavity 101 is different from the proximal opening direction of the body 1 . The needle body 2 punctures the tissue wall and performs relevant treatment. The needle body 2 may be an ablation needle for ablation therapy, an injection needle for injection therapy, or a needle body for other related medical purposes.

In some embodiments, the body 1 further includes a second cavity 102 . The second cavity 102 passes through the proximal end and the distal end of the main body 1 and generally extends along the axial direction of the main body 1 for passing the guide wire 3 . The proximal opening direction of the second chamber 102 is the same as the proximal opening direction of the body 1 , and the distal opening direction of the second chamber 102 is the same as the distal opening direction of the body 1 .

The proximal end of the main body 1 is connected to a catheter 4, which is a bendable tubular body with a certain axial length, so as to push the main body 1 into the patient's body, such as heart chambers, more specifically, right ventricle, right atrium, left ventricle, etc. ventricle or left atrium. The distal end of the main body is connected with the pigtail catheter 5 and/or the guide wire 3 . The guide wire 3 can axially pass through the second lumen 102 . , the guide wire 3 is a capillary wire with a certain length. After being punctured through the femoral vein or femoral artery, it reaches the target area through the catheter, thereby establishing a delivery path for medical devices from the outside to the body. Generally speaking, its length is usually the total length of the device More than twice as much, in order to meet the delivery demand. It can be understood that, in order to facilitate remote operation outside the patient's body, a handle 15 may be provided at the proximal end of the catheter 4 , and the handle 15 may adopt the prior art, which will not be repeated here.

Since the main body 1 needs to be in contact with blood in the body, the main body 1 can be made of biocompatible metal materials, such as titanium alloy, 316 stainless steel, tantalum, etc. In this embodiment, tantalum is preferred; the development effect of tantalum under ultrasound Better and more convenient to observe the position of guide components and tissues.

In some embodiments, the catheter 4 is a flexible elongated piece with a certain length. Since the needle body 2 is movably installed in the first lumen 101, the distal end of the catheter 4 extends into the first lumen 101 to wrap the needle body 2, In order to overcome the resistance of the needle coming out from the side, the catheter 4 needs to have a certain hardness and the hardness is smaller than that of the needle body, so as to protect the needle tip of the needle body 2 . The catheter 4 can be a flexible sheath, a PI tube, a metal cutting tube or a hose made of other materials. In some embodiments, conduit 4 is preferably a PI tube.

Preferably, the proximal end of the body 1 of the guide assembly is provided with a sleeve 108, the distal end of the catheter 4 is sleeved on the sleeve 108, and is bonded by a heat-shrinkable tube; the first cavity 101 communicates with the axial direction of the catheter 4 The inner cavity, and the needle body 2 is accommodated in the axial inner cavity of the catheter 4 .

Specifically, at least a part of the side wall of the body 1 having the needle outlet 103 is planar to form the needle outlet 104 , that is, the needle outlet surface of the body 1 that abuts against the tissue wall is planar. In practical applications, the planar shape is beneficial to increase the contact area to improve the abutment stability. Of course, in other embodiments, the contact surface between the body 1 and the tissue wall can also be in other shapes, such as adapting to the tissue wall The shape of the shape, and the shape of the surface, etc.

Preferably, referring to FIG. 2 and FIG. 3 , an anti-slip array is provided on the needle outlet surface 104 . The anti-slip array includes a plurality of anti-slip structures protruding from the needle surface 104 . Specifically, the number of columns of the anti-slip array is greater than or equal to 2, and the number of rows of the anti-slip array is greater than or equal to 2, so that multiple anti-slip structures form an array arrangement. Since each anti-slip structure is protruding from the needle surface, it is similar to a number of distributed columns. According to fluid dynamics, when the fluid flows through multiple column arrays, the fluid will be dispersed and a flow will be generated near each column. field. Therefore, when the high-speed blood in the heart chamber passes through the side of the anti-slip array, it can be dispersed by the multiple anti-slip structures arranged in the array. The high-speed blood flow is first dispersed into several slow-flowing streams, and due to the mutual The flow rate is further reduced due to the interference of the flow field, so as to avoid the displacement of the guiding component due to the high-speed impact of the blood flow.

It can be understood that a plurality of anti-slip structures can be arranged at regular intervals to form an array, or can be arranged irregularly and unevenly to form an array. Preferably, in order to ensure the uniform distribution of friction force and the stability when being washed by blood, A plurality of anti-slip structures are evenly arranged at intervals on the needle outlet surface 104 to form multiple rows and columns to form an anti-slip array.

In some of the embodiments, the ratio of the area of the anti-slip array to the area of the needle exit surface is greater than or equal to 20%. It can be understood that the anti-slip array has a certain area in order to effectively improve the static friction between the needle surface and the tissue wall, but if the area of the anti-slip array is too large, the outer diameter of the guide assembly will increase, which is not conducive to guiding The passability of the guide components in the curved blood vessels; and the restricted area of the inner wall of the heart is too large, which affects the normal beating of the heart. Preferably, in some of the embodiments, the length of the anti-slip array is in the range of 3-5 mm, and the width of the anti-slip array is in the range of 5-15 mm.

In some of these embodiments, the anti-slip structure protrudes from the needle surface 104 in a movable manner. The anti-slip structure includes at least one toothed part 6, and the side wall is provided with a perforation 105 corresponding to the toothed part 6, and the toothed part 6 can be arranged in the perforated hole 105 through the axial movement of the perforated hole 105, and the toothed part 6 is arranged as It can extend out of the needle face 104 or retract into the body 1 .

In this embodiment, the guide assembly is designed with a plurality of perforations 105 on the needle exit surface 104, and tooth-shaped parts 6 are movably arranged on the corresponding perforations 105. When it is necessary to use a non-slip structure to stick to the tissue wall, these The toothed part 6 extends out of the needle surface 104 to form a non-slip structure, so that the purpose of improving the abutment stability can be achieved; when the anti-slip structure is not required, for example, when withdrawing from the guide assembly, or guide When the assembly travels in the blood vessel, the toothed part 6 can be driven to retract into the guide body, so that there is no protrusion on the needle surface 104. In this way, the guide assembly can be prevented from retreating or The purpose of the non-slip structure causing scratches to other tissue walls during travel is to improve the safety of use.

Preferably, referring to Fig. 4 to Fig. 7, the anti-skid structure further includes a sliding part 7 and a driving part 8 for applying force to the sliding part 7, and the toothed part 6 is movably arranged on the sliding part along a direction parallel to the axial direction of the through hole 105. 7, so as to extend or retract into the body 1. Wherein, the force exerted by the driving member 8 on the sliding member 7 may be a pulling force or a pushing force, which is not limited in this application. Specifically, the sliding member 7 is arranged at the distal end of the driving member 8, the body 1 has a channel 106 axially penetrating and communicating with the second chamber 102, the driving member 8 is arranged in the channel 106, and the sliding member 7 is movably arranged in the second chamber 102 In the second chamber 102 , the sliding member 7 is driven to move in the second chamber 102 through the movement of the driving member 8 in the channel 106 . It can be understood that the anti-slip structure may not be provided with a separate driving member 8, but by controlling a part of the sliding member 7, such as its proximal end, the sliding member 7 can slide in the axial direction.

In order to ensure that the height h between the tip of the toothed part 6 and the needle exit surface 104 can increase the adsorption to the tissue without damaging the tissue, see Figure 8 and Figure 9, in this embodiment h is controlled between 0.2mm-1mm, preferably It is 0.5mm, so as to ensure no damage to the tissue and at the same time ensure the adsorption as much as possible. Usually, the tooth-shaped part 6 is characterized by triangular teeth, trapezoidal teeth, etc. In order to meet the requirement that the tooth-shaped part 6 can only be compressed in one direction, the limited instrument To avoid misoperation, this embodiment is preferably designed as a right-angled triangular tooth shape, and one right angle is upward, that is, the tip is upward, so that when the tooth-shaped member 6 is in the limit position, the tip is easy to contact with the tissue, thereby increasing frictional resistance .

Specifically, the toothed part 6 has a tip part 601 protruding from the needle surface, and the tip part 601 is formed with a slope 602, and the sliding part 7 is slid in the second cavity 102 along the axial direction of the body 1, which makes the There is an included angle between any line segment of the slope 602 and the needle outlet surface 104. This included angle is not only conducive to buffering the impact of the blood flow on the anti-slip structure, but also facilitates the dispersal of one blood flow into multiple streams. A fluid slow-release zone is formed between the plurality of slopes 602 to further slow down the velocity of the blood flow and avoid displacement of the guide assembly caused by blood impact. In addition, when the edge of the side wall of the perforation 105 interacts with the inclined surface 602, the perforation 105 will generate a component force on the tip portion 601 toward the second cavity 102, and this component force will promote the tip portion 601 to the second chamber 102. cavity 102, so as to achieve the purpose of retracting the toothed part 6; that is, when the sliding part 7 drives the toothed part 6 to move along the axial direction of the body 1 and makes the inclined surface 602 abut against the edge of the side wall of the perforated hole 105, the perforated hole 105 A pressing force is generated towards the second chamber 102 on the toothed part 6, so that the part of the toothed part 6 extending beyond the needle surface 104 can be squeezed into the second chamber 102, especially when the tip part 601 is completely When squeezed into the second cavity 102, the tooth-shaped part 6 can be completely retracted into the main body 1, so as to prevent the tooth-shaped part 6 from damaging the tissue during the delivery process of the blood vessel path, so that the guide assembly has Avoid scratching other non-target functions in the blood vessel adjoining the tissue wall, and improve the safety of use of the guiding component.

Preferably, referring to FIG. 3 and FIG. 6 , the slider 7 includes a slider 701 on which at least one fixing member 702 is detachably provided, and the slider 701 is slidably disposed in the second cavity 102 along the axial direction of the body 1 Inside, the distal end of the driving member 8 is set in the channel 106 and connected to the slider 701; at least one fixing member 702 is installed on the slider 701, and at least one fixing member 702 is arranged in a one-to-one correspondence with at least one through hole 105 . Wherein, the fixing part 702 is fixed on the sliding block 701 through the slotted hole on the sliding block 701, so as to ensure the connection reliability and avoid the detachment of the toothed part 6 . Wherein, the fixing part 702 has an inner cavity, at least one toothed part 6 is arranged in the inner cavity of at least one fixing part 702 through at least one elastic part 703, and the opening of the fixing part 702 is smaller than the maximum outer diameter of the toothed part 6, so as to The toothed part 6 cannot be disengaged from the fixing part 702 . Preferably, when the toothed part 6 is squeezed by the perforation 105, the toothed part 6 retracts into the fixing part 702, as shown in FIG. 6 extends out of the fixing member 702 and out of the needle surface 104 under the force of the elastic member, as shown in FIG. 4 and FIG. 6 .

In this example, in order to ensure that the elastic member 703 can be compressed and released multiple times, it is preferably a spring made of steel. Compared with stainless steel, steel has better elastic properties. At the same time, in order to avoid wear and fatigue, the material of the fixing part 702 and the toothed part 6 is preferably stainless steel 316.

Specifically, referring to Fig. 4, the position of the slider 7 when the toothed part 6 has the most protruding part on the needle exit surface 104 is the first position, referring to Fig. 5, the toothed part 6 is completely squeezed into the channel 106, the position of the slider 7 is the second position; when the slider 7 is in the first position, the toothed part 6 is in the middle of the perforation 105, and under the force of the spring 703, the tip of the toothed part 6 Part 601 protrudes from the needle exit surface 104. At this time, the tip part 601 is in the limit position, and the coefficient of static friction is the largest. The tip part 601 is easy to contact with the tissue wall, thereby increasing the friction force; is completely squeezed into the second cavity 102, at this time, the surface of the needle exit surface 104 is smooth, and the coefficient of static friction is the smallest.

That is to say, when the slider 7 moves from the first position to the second position, the anti-slip structure will be squeezed by the perforation 105 so that the anti-slip structure shrinks into the second cavity 102, and at this time the needle exit surface 104 gradually becomes smooth, The coefficient of friction is reduced; when the slider 7 moves from the second position to the first position, the anti-slip structure is exposed from the perforation 105 of the needle outlet surface 104, so that there are a plurality of sharp ends 601 on the needle outlet surface 104, and now the needle outlet surface 104 becomes rougher, the coefficient of friction increases.

In addition, the length of the slider 701 in the axial direction should be smaller than the length of the second cavity 102 in the axial direction, so that the slider 701 can move axially in the second cavity 102 , as shown in FIG. 8 and FIG. 9 .

Preferably, referring to FIGS. 2 and 3 , the guide assembly further includes a cover 107 for closing the second cavity 102 , the cover 107 is installed at the distal end of the body 1 for encapsulating the non-slip structure in the second cavity 102 Such as the slider 701 and the toothed part 6, etc. In addition, the guide wire 3 passes through the channel 106 to be exposed from the through hole of the cover 107, and the cover 107 is provided with a through hole for passing the guide wire 3 and assembling the pigtail catheter, so as to ensure the structural stability of the entire guide assembly after assembly Specifically, referring to FIG. 3 and FIG. 4 , the distal end of the cover 107 is rounded or chamfered to reduce damage to blood vessels or valves caused by the guide assembly when it enters the target area under the guidance of the guide wire 3 .

Preferably, referring to FIG. 1 and FIG. 2 , the proximal end and the distal end of the channel 106 pass through the proximal end and the distal end of the body 1 respectively for accommodating the guide wire 3 , and the second cavity 102 is arranged along the axial direction of the body 1 , And the guide wire 3 is movably installed in the second cavity 102 , and the sliding member 7 is provided with a threading hole, and the threading hole is arranged coaxially with the second cavity 102 . And it communicates with the second cavity 102, and the guide wire 3 is passed through the threading hole. The combined design of the channel 106 and the second chamber 102 is beneficial to actual production and reduces the overall volume of the body 1 to make its structure more compact. In addition, designing a threading hole 7011 on the slider 7 for the guide wire 3 to pass through can avoid structural interference between the slider 7 and the guide wire 3 , and is also conducive to making the structure compact and reducing the outer diameter of the device. In addition, since the guide wire 3 is threaded on the slider 701, and the guide wire 3 is arranged along the axial direction of the body 1, the guide wire 3 can also improve the axial movement stability of the slider 701 to ensure The anti-slip structure, that is, the smooth expansion and contraction of the toothed part 6, improves the structural stability.

Specifically, the driving part 8 adopts a shape memory tube with a certain length, and the commonly used shape memory tube can choose a flexible sheath, PI tube, metal cutting tube or tube of other materials. Axial pulling and pushing are performed to make the toothed part 6 shrink or protrude, preferably a stainless steel cut tube, and be connected with the slider 701 by welding, thereby ensuring the connection strength.

Preferably, referring to FIG. 1 , FIG. 8 and FIG. 10 , the angle α between the axis of the first chamber 101 at the needle outlet 103 and the needle outlet surface 104 ranges from 0° to 90°, preferably 75°. With such a design, the range of the needle exit angle of the needle body 2 can be controlled between 0°-90°, so as to realize the puncture of tissues that are difficult to reach by straight line puncture, especially the tissues that are lateral to the blood vessel direction, and improve the applicability of the guide assembly sex.

Preferably, referring to FIG. 4 and FIG. 5 , the first cavity 101 extends toward the central axis of the body 1 at the same time toward the distal end. Specifically, the first cavity 101 includes an axially extending cavity 1011 , a circular arc transition cavity 1012 and an inclined cavity. 1013; the axial extension cavity 1011 is located at the proximal end of the body 1, and the axial direction of the axial extension cavity 1011 is the same as the axial direction of the body 1; the proximal end of the arc transition cavity 1012 communicates with the distal end of the axial extension cavity 1011, and is inclined The proximal end of the cavity 1013 communicates with the distal end of the circular arc transition cavity 1012 , and the distal end of the inclined cavity 1013 penetrates the side wall of the body 1 to form a needle outlet 103 . By using a circular arc transition cavity to connect the axial extension cavity and the inclined cavity, the first cavity 101 has a guiding effect, which can limit the puncture track of the needle body 2, which is conducive to the smooth needle exit of the needle body 2 and avoids the deviation of the needle exit direction. . In addition, in this embodiment, the inner diameters of the cavity segments of the first cavity 101 may be equal or unequal, that is, the first cavity 101 may be a cavity segment of equal diameter or a cavity segment of variable diameter, In this embodiment, the equal-diameter lumen segment is preferred.

Preferably, the distance between the needle exit surface 104 and the axis of the axially extending cavity of the first cavity 101 is greater than the distance between the needle exit surface 104 at the proximal end of the body 1 and the axis of the axially extending cavity. Such design can make The degree of curvature of the arc transition cavity becomes gentler, which is conducive to stable needle exit. Specifically, the radial difference between the needle exit surface 104 and the needle exit surface 104 at the proximal end of the body 1 is 0mm-1.0mm, preferably 0.5mm.

For the tube body with a certain axial length and cross-sectional area such as the puncture needle tube 21, it is usually required to have a certain degree of flexibility and support, so that it can pass through curved blood vessels smoothly, and can not bend when puncturing tissue. fold or slip. The moment of inertia I value of the section is a geometric parameter to measure the bending resistance of the section. The smaller the I value, the stronger the flexibility of the tube body, the smaller the bending radius that can be achieved, and the stronger the adaptability to the vascular path. As mentioned above, the puncture needle tube 21 is a hollow structure, and its cross-section is a hollow circle. According to the formula of the moment of inertia I of the section of the hollow circle: I=π(D^4-d^4)/64, it can be known that the tube of the puncture needle tube 21 The smaller the diameter, the smaller the moment of inertia I, the smaller the bending radius of the puncture needle tube 21, and the stronger the adaptability to the blood vessel path, but at the same time, the support and puncture force of the tube will be correspondingly reduced. In this embodiment, in order to ensure the passability of the puncture needle tube 21 in the blood vessel and the puncture force on the tissue at the same time, the outer diameter of the puncture needle tube 21 ranges from 0.5 mm to 2.0 mm, and the inner diameter range of the puncture needle tube 21 ranges from 0.2 mm to 1.8 mm. . Wherein, the outer diameter range of the puncture needle tube can be 0.5mm, 1.0mm, 1.5mm, 2.0mm, 2.5mm, etc., and the inner diameter of the puncture needle tube 21 can be 0.2mm, 0.4mm, 0.6mm, 0.8mm, 1.0mm, 1.2mm , 1.4mm, 1.6mm, 1.8mm, etc., which are not limited here. In this embodiment, the outer diameter of the puncture needle tube 21 is preferably 1.0mm, and the inner diameter of the puncture needle tube 21 is 0.8mm.

Please refer to FIG. 11 , in some embodiments, for a specific example of the anti-slip structure, in addition to adopting the tooth-shaped member 6 structure disclosed in the above-mentioned embodiments, a solution of coating an anti-slip coating can also be adopted. The anti-skid coating is applied on the surface of the needle exit face and has a certain thickness, so as to fix and protrude from the needle exit face 104 . , as shown in FIG. 11 , the anti-slip structure is an anti-slip coating 9 coated on the needle exit surface 104 with a needle exit 103 in the main body 1, that is, at least one layer of anti-slip coating 9 is coated on the needle exit surface 104, through The anti-slip coating 9 is used to improve the static friction coefficient between the guide assembly and the tissue wall, so as to reduce the possibility that the needle body 2 is separated from the tissue wall due to the impact of the blood flow on the body 1, and improve the contact between the guide assembly and the tissue wall. The abutment stability between the walls.

Wherein, the material of the anti-slip coating 9 can be selected according to the actual situation, as long as it is biocompatible, and the coefficient of friction and/or surface roughness is greater than that of the needle exit surface 104 and/or the surface roughness.

Further, roughening treatment is carried out on the anti-slip coating to further increase the coefficient of friction, for example, the surface of the anti-slip coating has structures such as barbs and serrations, and the height of the anti-slip structure is further increased through shapes such as barbs and serrations, so that more A non-slip structure approximately in the shape of a column forms a non-slip array with a certain area, and the blood flow is dispersed through the columnar anti-slip structure. Through the above arrangement, when the guide assembly reaches the target abutment position, the side provided with the anti-slip structure is abutted against the tissue wall, and then the needle body 2 is protruded through the needle outlet 103 at the distal end of the first cavity 101 And penetrate into the tissue for ablation. After the ablation is completed, the needle body 2 is withdrawn from the needle outlet port 103 at the distal end of the first cavity 101 into the first cavity 101, and then the guide assembly is removed from the tissue wall to release the abutment state.

Please refer to Figures 12-13. In addition to the solutions disclosed in the above-mentioned embodiments, the specific solution of the anti-slip structure can also be in the form of directly fixing the protrusion 10 on the needle outlet surface 104, that is, see Figures 12 and 13. The anti-skid structure is a plurality of protrusions evenly distributed on the needle exit surface 104. By designing a plurality of protrusions 10 on the needle exit surface 104, the roughness of the needle exit surface 104 is increased, thereby increasing the coefficient of friction to achieve The purpose of improving the sticking stability.

In this embodiment, the specific structure of the protrusion 10 can adopt structures such as barbs and sawtooth. Preferably, the anti-slip feature is designed as a tooth-shaped structure. Triangular tooth shape; it is convenient for the guide component to be adsorbed on the tissue wall, increasing the adhering strength with the tissue wall, making the puncture of the needle body 2 more accurate and stable, and the tooth shape of the anti-slip structure is sharpened to remove sharp corners and reduce Damage tissue during exercise in the body.

Referring to Fig. 14, on the basis of the above embodiments, this embodiment provides an ablation device, including a delivery assembly 11, an ablation assembly 12, and the above-mentioned guide assembly; the delivery assembly includes a guide sheath with a hollow lumen and a bending adjustment The sheath 1101, the bending adjustment sheath 1101 is movably set in the guide sheath, the guiding component is movably set in the bending adjustment sheath 1101 and can move axially and circumferentially in the hollow cavity of the bending adjusting sheath 1101, specifically guiding the guiding component The catheter is set in the bending adjustment sheath 1101, and the main body 1 of the guide assembly can protrude from the distal end of the bending adjustment sheath 1101 and abut against the tissue wall. The ablation assembly 12 includes a needle body 2 and a connecting piece (not shown), the needle body 2 is movably installed in the first cavity 101 of the guide assembly, and the distal end of the needle body 2 can extend out of the first cavity 101 of the guide assembly the distal end; and adjust the position of the first cavity 101 to drive the needle body 2 to point to and insert into different positions of the tissue, so as to perform tissue ablation operation. Wherein, the distal end of the connector is bonded and fixed to the proximal end of the needle body 2 , and the proximal end of the connector is connected to the radio frequency device and the liquid infusion device through threads, and the radio frequency energy and liquid are transmitted to the needle body 2 through the connector.

In addition, for the specific structure of the guide assembly, reference may be made to the above-mentioned embodiments, which will not be repeated here.

Further, the above-mentioned ablation system further includes a mapping device, which is connected to the guide assembly through a wire. At least one electrode can be arranged on the side wall of the main body 1, or the guide assembly is at least partially made of a conductive material (such as a metal material), the tube wall of the catheter has a built-in wire, and the distal end of the wire is connected to the electrode or the guide assembly. The conductive part is connected, and the proximal end of the wire is connected with the mapping system.

Referring to Fig. 15 and Fig. 16, on the basis of the above-mentioned embodiments, this embodiment proposes an ablation system, including an ablation energy generating device 13 and the above-mentioned ablation device; the ablation energy generating device 13 is connected to the ablation device, and the ablation energy generating device 13 is configured to be able to provide energy for the ablation device, so that the needle body 2 performs tissue ablation. In addition, the ablation system further includes a perfusion device 14 for providing perfusion liquid for the ablation device, and the perfusion liquid flows through the inner cavity of the needle body 2 . Wherein, the specific content about adjusting the direction of the needle body 2 can refer to US5558673A and US5370675A, and the specific content about the bending adjustment sheath can also refer to CN110215593A and CN214286246U, and will not be repeated here.

Taking puncture through the femoral artery, reaching the left ventricle through the aortic arch, and performing myocardial radiofrequency ablation on the aortic outflow tract as an example, describe the working process of the ablation system provided by this application:

As shown in Figure 15, the channel from the outside of the body to the inside of the body is established through the cooperation of the guide sheath and the guide wire of the ablation device. When the distal end of the curved sheath 1101 is in the ascending aorta and close to the aortic valve, the bending sheath 1101 is positioned, and then the guide assembly is stretched out from its distal opening through the bending sheath, and the guide assembly is adjusted across the aortic valve. arterial valve.

As shown in FIG. 16 , adjust the guide assembly to the target position, and allow it to abut against the target tissue wall. In some embodiments, the needle-exiting surface 104 of the guide assembly has a non-slip structure that does not need to be adjusted, and the guide assembly can directly make its needle-exiting surface 104 abut against the target tissue wall. In some embodiments, a non-slip structure is adjusted on the needle exit surface 104 of the guide assembly, and then it is made to abut against the target tissue wall. In some embodiments, the needle-exiting surface 104 of the guide assembly is first abutted against the target tissue wall, and then a non-slip structure is adjusted on the needle-exiting surface 104 of the guide assembly.

When the guide assembly is firmly attached to the target tissue wall, the needle body 2 is driven to puncture the target tissue, and then ablation treatment is performed on the target tissue through the energy transmission of the ablation energy generating device 13; Needle body 2, the anti-slip structure of the guide assembly (if necessary), the bending sheath and the guide sheath, etc.

In addition, for the specific structure of the ablation device, reference may be made to the above-mentioned embodiments, which will not be repeated here.

On the basis of the above-mentioned guide assembly embodiment, this embodiment provides an injection device, including the above-mentioned guide assembly, delivery assembly, and injection assembly. The delivery assembly includes an introducer sheath and a bend-adjusting sheath. In the guiding sheath, the guiding component is arranged in the bending-adjusting sheath, the proximal end of the guiding component is connected with the distal end of the catheter, and the injection component includes an injection needle, which is movably arranged in the first cavity of the guiding component. Through this setting, the injection assembly can exit the needle through the needle exit port of the guide assembly. At the same time, due to the anti-skid structure provided on the needle exit surface, the needle exit surface is in close contact with the target tissue wall, and the needle body is driven to exit the target tissue. After needle puncture, the hydrogel and other medicinal liquids are injected into the target tissue to complete the treatment. It can be understood that the handle 15 is also provided with an injection part 16, and the injection part 16, the catheter and the injection assembly are connected. When the guiding component is inserted into the body through the catheter and reaches the target position, the guiding component is abutted against the target tissue wall, and after the guiding component and the target tissue wall are firmly attached, the handle 15 is driven to make the needle body go out to the target tissue. After needle puncture, inject liquid such as hydrogel into the injection part 16 to inject it into the target tissue; after the injection is completed, withdraw the needle body 2, the anti-slip structure of the guide assembly (if necessary), the bending sheath, etc. in sequence.

The technical means disclosed in the solutions of the present invention are not limited to the technical means disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be pointed out that those skilled in the art can make some improvements and modifications without departing from the principle of the present invention, and these improvements and modifications are also considered as the protection scope of the present invention.

Claims

A guide assembly for guiding a needle body, characterized in that it includes a body, the body has a first cavity for the needle body to pass through, the side wall of the body is provided with a needle exit surface, the The distal end of the first cavity is provided with a needle outlet on the needle outlet surface, and the guide assembly also includes an anti-skid array, and the anti-skid array includes a plurality of anti-skid structures, and the anti-skid structures protrude from the needle outlet noodle.
The guide assembly according to claim 1, wherein the number of columns of the anti-slip array is greater than or equal to two, and the number of rows of the anti-slip array is greater than or equal to two.
The guide assembly according to claim 2, wherein the ratio of the area of the anti-slip array to the area of the needle exit surface is greater than or equal to 20%.
The guide assembly according to claim 3, wherein the length of the anti-slip array is in the range of 3-5 mm, and the width of the anti-slip array is in the range of 5-15 mm.
The guide assembly according to claim 1, wherein the anti-slip structure is fixedly or movably protrudes from the needle exit surface.
The guide assembly according to claim 5, wherein the anti-slip structure comprises an anti-slip coating, and the anti-slip coating is at least partially coated on the needle exit surface.
The guide assembly according to claim 6, characterized in that the surface roughness of the anti-slip coating is greater than the surface roughness of the needle exit surface.
The guide assembly according to claim 5, wherein the anti-slip structure includes a toothed piece, and the side wall is provided with a through hole corresponding to the toothed piece, and the toothed piece passes through the through hole Protrude from the needle exit surface or retract into the body.
The guide assembly according to claim 8, wherein the body further comprises a second chamber; the anti-slip structure further comprises a sliding member; the sliding member is arranged in the second chamber and can axially moving the slider in the second cavity;

The toothed part is movably arranged on the sliding part.
The guide assembly according to claim 9, wherein an inclined surface is provided at one end of the toothed member protruding from the needle exit surface, and there is an included angle between the inclined surface and the needle exit surface; The other end of the toothed part is connected with the sliding part through an elastic part;

The perforated sidewall edge presses against the ramp to retract the tooth into the slide.
The guide assembly according to claim 10, wherein the sliding member comprises a sliding block, and at least one fixing member is detachably arranged on the sliding block; the toothed member is arranged on the on the fixture.
The guiding assembly according to any one of claims 9-11, wherein the sliding member is provided with an axially penetrating channel, and the channel communicates with the second chamber.
The guide assembly according to any one of claims 1 to 11, wherein the included angle between the axial direction of the needle outlet and the needle outlet surface ranges from 0° to 90°.
The guiding assembly according to any one of claims 1 to 11, wherein the guiding assembly further comprises a catheter and a handle, the guiding assembly is arranged at the distal end of the catheter, and the handle is arranged at the proximal end of the catheter.
An ablation device, characterized by comprising a transport assembly, an ablation assembly and the guide assembly according to any one of claims 1-14;

The delivery assembly includes an introducer sheath and a bend-adjusting sheath, the bend-adjustable sheath is movably installed in the guide sheath, and the guide assembly is arranged in the bend-adjustable sheath;

The ablation assembly includes an ablation needle, and the ablation needle is movably installed in the first cavity of the guide assembly.
An ablation system, characterized by comprising an ablation energy generating device and the ablation device according to claim 15; the ablation energy generating device is connected to the ablation device, and the ablation energy generating device provides ablation for the ablation device energy.
The ablation system according to claim 16, characterized in that:

The ablation system further includes a perfusion device for providing perfusion liquid to the ablation device, and the perfusion liquid flows through the lumen of the ablation needle.
The ablation system according to claim 16, characterized in that: the ablation system further comprises a mapping device, and the mapping device is connected to the guiding assembly through a wire.
The ablation system according to claim 18, wherein at least one electrode is arranged on the side wall, the wire is arranged in the tube wall of the catheter, and the distal end of the wire is connected to the electrode.
The ablation system according to claim 18, wherein the guide assembly is at least partially made of conductive material, the guide wire is arranged in the tube wall of the catheter, and the distal end of the guide wire is connected to the guide guide Lead component connection.
An injection device, characterized by comprising a delivery assembly, an injection assembly and the guide assembly according to any one of claims 1-14;

The delivery assembly includes an introducer sheath and a bend-adjusting sheath, the bend-adjustable sheath is movably installed in the guide sheath, and the guide assembly is arranged in the bend-adjustable sheath;

The injection assembly includes an injection needle movably disposed in the first cavity of the guide assembly.