A guide assembly and device, system having the same

Abstract

The application discloses a guide assembly and an ablation device and system with the same, and is characterized in that the guide assembly is used for guiding a needle body and comprises a body, the body is internally provided with a first cavity for the needle body to pass through, a side wall of the body is provided with a needle outlet surface, a distal end of the first cavity is provided with a needle outlet at the needle outlet surface, and the guide assembly further comprises an anti-skid array, the anti-skid array comprises a plurality of anti-skid structures, and the anti-skid structures protrude from the needle outlet surface. By arranging the anti-skid array, the static friction coefficient between the guide assembly and a tissue wall can be improved, and more importantly, the impact force of blood flow can be reduced through the array arrangement of the plurality of anti-skid structures, so that the abutting stability of the guide assembly on the tissue wall is improved, and the problem that the needle body is easy to deviate from a treatment area due to tissue movement or blood flow impact is solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a guiding component and a device or system having the component. Background Technology

[0002] Existing technologies (US5558673A and US5370675A) disclose a guide assembly for guiding the exit angle and direction of a puncture needle. Specifically, after delivering the guide assembly to the target location, the puncture point is first determined, then the surface of the guide assembly is placed against the tissue wall. The exit angle is then adjusted, and after determining the exit angle, the needle is withdrawn for puncture and treatment. In the above method, the exit surface of the guide assembly needs to remain in contact with the tissue wall during the adjustment of the exit angle, needle withdrawal, and treatment. When this guide assembly is applied to treatment within the heart chambers, because the heart is constantly in a rapid beating state, and each beating cycle includes both expansion and contraction, the guide assembly cannot maintain contact with the inner wall of the heart. Furthermore, during the process of the guide assembly contacting the inner wall of the heart, it is subjected to high-speed impact forces from the blood flow within the heart, which can easily cause the guide assembly to detach from the tissue wall.

[0003] If the guide component detaches from the tissue wall before needle withdrawal, the surgeon must reselect the puncture point, leading to increased surgical time and reduced surgical efficiency. If the guide component detaches from the tissue wall during needle withdrawal, it will cause the puncture point to shift and the needle travel to increase accordingly. This is not only detrimental to the treatment, but in severe cases, it may even puncture the heart and endanger the patient's life. Summary of the Invention

[0004] In order to overcome at least one of the defects described in the prior art, one of the objectives of the present invention is to provide a guiding component that, by setting an anti-slip array with multiple anti-slip structures on the needle exit surface, can not only improve the static friction coefficient between the guiding component and the tissue wall, but more importantly, reduce the impact force of blood flow through the multiple anti-slip structures arranged in the array, thereby improving the stability of the guiding component on the tissue wall and solving the problem that the needle body is prone to deviating from the treatment area due to tissue movement or blood flow impact.

[0005] Another object of the present invention is to provide an ablation device for ablating myocardial tissue by puncturing the endocardium through the guiding device.

[0006] Another object of the present invention is to provide an ablation system for ablating myocardial tissue by puncturing the endocardium through the guiding device.

[0007] Another object of the present invention is to provide an injection device for injecting therapeutic agents into myocardial tissue by puncturing the endocardium through the guiding device.

[0008] Another object of the present invention is to provide an injection system for injecting therapeutic agents into myocardial tissue by puncturing the endocardium through the guiding device.

[0009] The technical solution adopted by this invention to solve its problem is:

[0010] A guiding assembly for guiding a needle body includes a body having a first cavity for the needle body to pass through, a needle exit surface being provided on the side wall of the body, and a needle exit port being provided at the distal end of the first cavity on the needle exit surface. The guiding assembly further includes an anti-slip array comprising multiple anti-slip structures protruding from the needle exit surface.

[0011] According to another aspect of the present invention, this application provides an ablation device, including a delivery component, an ablation component, and the aforementioned guiding component;

[0012] The delivery assembly includes a conduit with a hollow inner lumen, and the guiding assembly is disposed at the distal end of the conduit;

[0013] The ablation assembly includes a needle body that is movably disposed within the first cavity of the guiding assembly. Thus, the delivery assembly is inserted into the heart via a catheter, and the needle body, after exiting the delivery assembly through the guiding assembly, penetrates the endocardium and enters the myocardial tissue to ablate the myocardial tissue.

[0014] According to another aspect of the present invention, this application provides an ablation system, including an ablation energy generating device and the above-described ablation device;

[0015] The ablation energy generating device is connected to the ablation device, and the ablation energy generating device is configured to provide energy to the ablation device so that the needle body can perform tissue ablation.

[0016] According to another aspect of the present invention, this application provides an injection device, including a delivery assembly and an injection assembly, the delivery assembly including a catheter and a guide assembly as described above, the proximal end of the guide assembly being connected to the distal end of the catheter; and

[0017] The injection assembly includes an injection needle, which is movably disposed within the first cavity of the guide assembly.

[0018] According to another aspect of the present invention, this application provides an injection system including the injection device as described above, the injection device further including at least one injection part, the injection part being connected to the injection needle.

[0019] In summary, compared with the prior art, the embodiments of this application have at least the following technical effects:

[0020] Multiple anti-slip structures are protruding from the needle exit surface of the guide component and arranged in an array. This not only increases the static friction coefficient between the guide component and the tissue wall, thus preventing the needle from detaching from the guide component due to tissue movement, but also, because the multiple anti-slip structures are arranged in an array, when high-speed blood flows past the side of the array, it can be dispersed by the multiple anti-slip structures arranged in the array. The high-speed blood flow is dispersed into several slow-flowing 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 flow causing the needle exit surface to move or detach. This improves the adhesion stability of the guide component to the tissue wall and solves the problem of the needle deviating from the predetermined treatment area. Attached Figure Description

[0021] Figure 1 This is a schematic diagram illustrating the assembly between the body and the guidewire in some embodiments;

[0022] Figure 2 This is an exploded view of the relationship between the slider and the body;

[0023] Figure 3 This is a schematic diagram of the sliding component;

[0024] Figure 4 This is a schematic diagram showing the assembly of the sliding component on the body when the toothed component extends.

[0025] Figure 5 This is a schematic diagram of the sliding component being assembled on the body when the toothed component retracts.

[0026] Figure 6 A schematic diagram of the structure when the toothed part extends out of the fixing part;

[0027] Figure 7 A schematic diagram of the toothed component retracting into the fixing component;

[0028] Figure 8 This is a schematic diagram of the structure of the main body inside the bending sheath;

[0029] Figure 9 for Figure 8 A magnified view of part A in the middle;

[0030] Figure 10 for Figure 8 A magnified view of part B in the middle section;

[0031] Figure 11 This is a schematic diagram of the body structure when an anti-slip coating is applied to the needle surface in some embodiments;

[0032] Figure 12 This is a schematic diagram of the structure when protrusions are provided on the body in some embodiments;

[0033] Figure 13 for Figure 14 A magnified view of part C in the middle;

[0034] Figure 14 This is a schematic diagram of the ablation device described in some embodiments;

[0035] Figure 15 This is a schematic diagram of the ablation system described in some embodiments;

[0036] Figure 16 Schematic diagram of ablation needle inserted into target tissue for ablation treatment

[0037] Figure 17 This is a schematic diagram of the injection system described in some embodiments.

[0038] The meanings of the reference numerals in the attached figures are as follows:

[0039] 1. Body; 101. First cavity; 1011. Axial extension cavity; 1012. Arc transition cavity; 1013. Inclined cavity; 102. Second cavity; 103. Needle outlet; 104. Needle outlet surface; 105. Perforation; 106. Channel; 107. Cap; 108. Tube sleeve; 2. Needle body; 3. Guide wire; 4. Catheter; 5. Pigtail catheter; 6. Toothed component; 601. Tip; 602. Inclined surface; 7. Sliding component; 701. Sliding block; 7011. Wire insertion hole; 702. Fixing component; 703. Elastic component; 8. Driving component; 9. Anti-slip coating; 10. Protrusion; 11. Delivery assembly; 1101. Adjustable sheath; 12. Ablation assembly; 13. Ablation energy generating device; 14. Infusion device; 15. Handle; 16. Injection section. Detailed Implementation

[0040] To better understand and implement this invention, the technical solutions in the embodiments of this invention will be clearly and completely described below with reference to the accompanying drawings.

[0041] In the description of this invention, it should be noted that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0043] Please see Figures 1 to 2 Some embodiments disclose a guiding assembly including a body 1, which has a first cavity 101 for a needle 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 guiding assembly also includes an anti-slip array, which includes a plurality of anti-slip structures protruding from the needle outlet surface 104.

[0044] When the needle exit surface 104 of the guide component is against the tissue wall, the anti-slip array abuts against the tissue wall. Each anti-slip structure can increase the static friction coefficient between the needle exit surface 104 and the tissue wall. When the needle exit surface 104 is against the tissue wall, the large static friction between the two can prevent the guide component from detaching from the tissue wall due to tissue movement during the contact process. Furthermore, since 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. The high-speed blood flow is dispersed into several slow-flowing fine streams, and the flow velocity is further reduced due to the mutual flow field interference. This improves the contact stability between the guide component and the target tissue wall, reduces the number of times the puncture point needs to be reselected, and thus improves the efficiency of puncture treatment.

[0045] Therefore, the guiding components provided by the embodiments of this application are particularly suitable for intracardiac intracavitary treatments, such as catheter-directed endocardial ablation or catheter-directed endocardial injection.

[0046] The first cavity 101 penetrates the proximal and distal ends of the body 1 and extends generally along the axial direction of the body 1. Further, the proximal opening of the first cavity 101 is oriented in the same direction as the proximal opening of the body 1, while the distal opening of the first cavity 101 is oriented differently from the proximal opening of the body 1. The needle body 2 punctures the tissue wall and performs related treatments. The needle body 2 can be an ablation needle for ablation therapy, an injection needle for injection therapy, or a needle for other related medical purposes.

[0047] In some embodiments, the body 1 further includes a second cavity 102. The second cavity 102 penetrates the proximal and distal ends of the body 1 and extends substantially along the axial direction of the body 1, for inserting the guide wire 3. The proximal opening direction of the second cavity 102 is the same as the proximal opening direction of the body 1, and the distal opening direction of the second cavity 102 is the same as the distal opening direction of the body 1.

[0048] The proximal end of the main body 1 is connected to a catheter 4, which is a flexible tube with a certain axial length, thereby pushing the main body 1 into the patient's body, such as a heart chamber, more specifically, the right ventricle, right atrium, left ventricle, or left atrium. The distal end of the main body is connected to a pigtail catheter 5 and / or a guidewire 3. The guidewire 3 can axially penetrate the second lumen 102. The guidewire 3 is a capillary filament of a certain length, which serves as a delivery path for the medical device from outside the body to inside the body after puncture via the femoral vein or femoral artery and through the catheter. Generally, its length is usually more than twice the total length of the device to meet delivery requirements. Understandably, to facilitate remote operation outside the patient's body, a handle 15 can also be provided at the proximal end of the catheter 4. The handle 15 can adopt existing technology, which will not be described in detail here.

[0049] Since the main body 1 needs to come into 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; tantalum has better imaging effect under ultrasound, making it easier to observe the position of the guide component and the tissue.

[0050] In some embodiments, the conduit 4 is a flexible, elongated piece of a certain length. Since the needle body 2 is movably inserted into the first cavity 101, the distal end of the conduit 4 extends into the first cavity 101 to enclose the needle body 2. To overcome the resistance of lateral needle exit, the conduit 4 needs a certain degree of rigidity, but its rigidity is less than that of the needle body, to protect the needle tip of the needle body 2. The conduit 4 can be a flexible sheath, a PI tube, a metal cutting tube, or a flexible tube made of other materials. In some embodiments, the conduit 4 is preferably a PI tube.

[0051] 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 bonded by heat shrink tubing; the first cavity 101 connects to the axial inner cavity of the catheter 4, and the needle body 2 is housed in the axial inner cavity of the catheter 4.

[0052] Specifically, at least a portion of the sidewall of the body 1 with the needle outlet 103 is planar to form the needle outlet surface 104, that is, the needle outlet surface of the body 1 that abuts against the tissue wall is planar. In practical applications, a planar shape is beneficial for increasing the contact area to improve the stability of contact. Of course, in other embodiments, the contact surface between the body 1 and the tissue wall can also be other shapes, such as shapes adapted to the shape of the tissue wall, and curved surfaces, etc.

[0053] Preferably, see Figure 2 and Figure 3An anti-slip array is provided on the needle exit surface 104. The anti-slip array includes multiple anti-slip structures protruding from the needle exit surface 104. Specifically, the number of columns and rows of the anti-slip array are greater than or equal to 2, thus forming an array arrangement of multiple anti-slip structures. Since each anti-slip structure protrudes from the needle exit surface, similar to several distributed columnar bodies, according to fluid dynamics, when fluid flows through the array of multiple columnar bodies, the fluid is dispersed and a flow field is generated near each column. Therefore, when the high-speed blood flowing through 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 the flow velocity is further reduced due to the mutual flow field interference, thereby preventing the guide component from being displaced by the high-speed impact of the blood flow.

[0054] It is understood that multiple anti-slip structures can be arranged evenly to form an array, or they can be arranged irregularly and unevenly to form an array. Preferably, in order to ensure the uniform distribution of friction and stability when flushed by blood, multiple anti-slip structures are evenly spaced on the needle outlet surface 104 to form multiple rows and columns to form an anti-slip array.

[0055] In some 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 is understood that the anti-slip array needs a certain area to effectively improve the static friction between the needle exit surface and the tissue wall. However, if the area of ​​the anti-slip array is too large, it will increase the outer diameter of the guide component, which is detrimental to the passage of the guide component in tortuous blood vessels; and the excessive restriction area on the inner wall of the heart will affect the normal pulsation of the heart. Preferably, in some embodiments, the length of the anti-slip array ranges from 3 to 5 mm, and the width of the anti-slip array ranges from 5 to 15 mm.

[0056] In some embodiments, the anti-slip structure movably protrudes from the needle exit surface 104. The anti-slip structure includes at least one toothed member 6, and a through hole 105 corresponding to the toothed member 6 is provided on the side wall. The toothed member 6 is axially movable in the through hole 105, and the toothed member 6 is configured to extend out of the needle exit surface 104 or retract into the body 1.

[0057] In this embodiment, the guide assembly has multiple perforations 105 on the needle exit surface 104, and toothed members 6 are movably arranged on the corresponding perforations 105. When an anti-slip structure is needed to adhere to the tissue wall, these toothed members 6 are driven to extend out of the needle exit surface 104 to form an anti-slip structure, thereby improving the stability of the adhesion. When the anti-slip structure is not needed, such as when withdrawing the guide assembly or when the guide assembly is traveling in the blood vessel, the toothed members 6 can be driven to retract into the guide body, so that there are no protrusions on the needle exit surface 104. In this way, the anti-slip structure can be prevented from scratching other tissue walls during the retraction or travel of the guide assembly, thereby improving the safety of use.

[0058] Preferably, see Figures 4 to 7 The anti-slip structure also includes a sliding member 7 and a driving member 8 for applying force to the sliding member 7. A toothed member 6 is movably disposed on the sliding member 7 in a direction parallel to the axial direction of the through hole 105, thereby extending or retracting into the body 1. The force exerted by the driving member 8 on the sliding member 7 can be a pulling force or a pushing force, which is not limited in this application. Specifically, the sliding member 7 is disposed at the distal end of the driving member 8. The body 1 has an axially penetrating channel 106 communicating with the second cavity 102. The driving member 8 is disposed in the channel 106, and the sliding member 7 is movably disposed within the second cavity 102. The movement of the driving member 8 within the channel 106 drives the sliding member 7 to move within the second cavity 102. It is understood that the anti-slip structure may also not have a separate driving member 8, but instead achieve axial sliding of the sliding member 7 by controlling a portion of the sliding member 7, such as its proximal end.

[0059] To ensure that the height h of the tip of the toothed component 6 from the needle exit surface 104 increases its adhesion to the tissue without damaging it, see [reference needed]. Figure 8 and Figure 9 In this embodiment, h is controlled between 0.2mm and 1mm, preferably 0.5mm. This ensures that the tissue is not damaged while maximizing the adsorption. Typically, the toothed part 6 has features such as triangular teeth or trapezoidal teeth. To ensure that the toothed part 6 can only be compressed in one direction, limiting the use of the instrument and avoiding misoperation, this embodiment is preferably designed with right-angled triangular teeth, with one right angle pointing upwards. That is, by having the tip pointing upwards, it is easy for the tip of the toothed part 6 to contact the tissue when it is in the extreme position, thereby increasing the frictional resistance.

[0060] Specifically, the toothed member 6 has a pointed tip 601 protruding from the needle surface. The pointed tip 601 is formed with a bevel 602. The sliding member 7 is slidably disposed in the second cavity 102 along the axial direction of the body 1. This makes any line segment passing through the bevel 602 have an angle with the needle surface 104. This angle not only helps to buffer the impact of blood flow on the anti-slip structure, but also facilitates the dispersion of a blood flow into multiple thin streams and the formation of a fluid slow-release zone between multiple bevels 602, further slowing down the speed of blood flow and preventing blood impact from causing the guide component to shift. Furthermore, when the sidewall edge of the perforation 105 interacts with the inclined surface 602, the perforation 105 generates a force component towards the second cavity 102 on the tip 601. This force component causes the tip 601 to move into the second cavity 102, thereby achieving the purpose of retracting the toothed member 6. That is, when the slider 7 drives the toothed member 6 to move along the axial direction of the body 1 and the inclined surface 602 abuts against the sidewall edge of the perforation 105, the perforation 105 generates a squeezing force towards the second cavity 102 on the toothed member 6, so as to squeeze the portion of the toothed member 6 extending out of the needle surface 104 into the second cavity 102. In particular, when the tip 601 is completely squeezed into the second cavity 102, the purpose of completely retracting the toothed member 6 into the body 1 can be achieved, so as to avoid the toothed member 6 damaging the tissue during the delivery process in the blood vessel path. This allows the guide assembly to avoid scratching other non-target tissue walls in the blood vessel, thereby improving the safety of the guide assembly.

[0061] Preferably, see Figure 3 , Figure 6 The sliding member 7 includes a slider 701, on which at least one fixing member 702 is detachably provided. The slider 701 is slidably disposed within the second cavity 102 along the axial direction of the body 1. The distal end of the driving member 8 is disposed within the channel 106 and connected to the slider 701. At least one fixing member 702 is mounted on the slider 701, and at least one fixing member 702 is correspondingly disposed with at least one through hole 105. The fixing member 702 is fixed to the slider 701 through a slot in the slider 701 to ensure reliable connection and prevent the toothed member 6 from detaching. The fixing member 702 has an inner cavity, and at least one toothed member 6 is disposed within the inner cavity of at least one fixing member 702 by at least one elastic member 703. The opening of the fixing member 702 is smaller than the maximum outer diameter of the toothed member 6, so that the toothed member 6 cannot detach from the fixing member 702. Preferably, when the toothed member 6 is squeezed by the through hole 105, the toothed member 6 retracts into the fixing member 702, such as... Figure 7 As shown, when the toothed member 6 is not squeezed by the perforation 105, the toothed member 6 extends out of the fixing member 702 and extends out of the needle surface 104 under the action of the elastic member, as... Figure 4 and Figure 6 As shown.

[0062] In this example, to ensure that the elastic element 703 can withstand multiple compressions and releases, it is preferably made of steel, as steel has better elastic properties than stainless steel. Meanwhile, to avoid wear and fatigue, the fastener 702 and the toothed element 6 are preferably made of 316 stainless steel.

[0063] For details, please refer to Figure 4 The first position is the position of the sliding member 7 when the toothed member 6 has the most protruding portion on the needle outlet surface 104, see [reference]. Figure 5 The second position is defined as the position of the sliding member 7 when the toothed member 6 is fully squeezed into the channel 106. When the sliding member 7 is in the first position, the toothed member 6 is in the center of the perforation 105. Under the action of the elastic member 703, the tip 601 of the toothed member 6 protrudes from the needle exit surface 104. At this time, the tip 601 is in the extreme position, the static friction coefficient is the maximum, and the tip 601 is easy to contact the tissue wall, thereby increasing the friction. When the sliding member 7 is in the second position, the tip 601 is fully squeezed into the second cavity 102. At this time, the surface of the needle exit surface 104 is smooth, and the static friction coefficient is the minimum.

[0064] In other words, when the slider 7 moves from the first position to the second position, the anti-slip structure will be squeezed by the perforation 105, causing the anti-slip structure to shrink into the second cavity 102. At this time, the needle outlet surface 104 gradually becomes smooth and the coefficient of friction decreases. 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 the needle outlet surface 104 has multiple sharp points 601. At this time, the needle outlet surface 104 becomes rough and the coefficient of friction increases.

[0065] Furthermore, the axial length of slider 701 should be less than the axial length of second cavity 102 so that slider 701 can move axially within second cavity 102, such as... Figure 8 and Figure 9 As shown.

[0066] Preferably, see Figure 2 and Figure 3 The guide assembly also includes a cap 107 for sealing the second cavity 102. The cap 107 is installed at the distal end of the body 1 and is used to enclose the anti-slip structure inside the second cavity 102, such as the slider 701 and the toothed member 6. Additionally, the guide wire 3 passes through the channel 106 and protrudes from the through-hole of the cap 107. The cap 107 has a through-hole for the guide wire 3 to pass through and for mounting the pigtail catheter, ensuring the structural stability of the entire guide assembly after assembly. For details, see [link to documentation]. Figure 3 and Figure 4 The distal end of the cap 107 has a rounded or chamfered edge to reduce damage to blood vessels or valves during the process of the guiding assembly entering the target area under the guidance of the guidewire 3.

[0067] Preferably, see Figure 1 and Figure 2 The proximal and distal ends of channel 106 extend through the proximal and distal ends of body 1, respectively, to accommodate guidewire 3. Second cavity 102 is arranged along the axial direction of body 1, and guidewire 3 is movably inserted through second cavity 102. Sliding member 7 has a threading hole, which is coaxially arranged with and communicates with second cavity 102, through which guidewire 3 passes. Combining channel 106 and second cavity 102 in a single design facilitates actual production and reduces the overall volume of body 1, making its structure more compact. Furthermore, the threading hole 7011 on sliding member 7 allows guidewire 3 to pass through, avoiding structural interference between sliding member 7 and guidewire 3, and also contributes to a compact structure and reduced instrument outer diameter. Additionally, since guidewire 3 passes through slider 701 and is arranged along the axial direction of body 1, guidewire 3 also improves the axial movement stability of slider 701, ensuring smooth extension and retraction of the anti-slip structure, i.e., toothed member 6, and improving structural stability.

[0068] Specifically, the driving component 8 adopts a shape memory tube with a certain length. Commonly used shape memory tubes can be flexible sheath tubes, PI tubes, metal cutting tubes, or tubes of other materials. In this embodiment, since it is necessary to pull and push the sliding component 7 axially, the toothed component 6 will shrink or bulge. Stainless steel cutting tubes are preferred, and they are connected to the slider 701 by welding to ensure the connection strength.

[0069] Preferably, see Figure 1 , Figure 8 and Figure 10 The angle α between the axis of the first cavity 101 at the needle outlet 103 and the needle outlet surface 104 ranges from 0° to 90°, with a preferred angle of 75°. This design allows the needle outlet angle of the needle body 2 to be controlled within the range of 0° to 90°, enabling puncture of tissues that are difficult to reach with straight puncture, especially tissues lateral to blood vessels, thus improving the applicability of the guide assembly.

[0070] Preferably, see Figure 4 and Figure 5The first cavity 101 extends distally and simultaneously toward the central axis of the body 1. Specifically, the first cavity 101 includes an axially extending cavity 1011, an arc-shaped transition cavity 1012, and an inclined cavity 1013. The axially extending cavity 1011 is located at the proximal end of the body 1, and the axis of the axially extending cavity 1011 is the same as the axis of the body 1. The proximal end of the arc-shaped transition cavity 1012 connects to the distal end of the axially extending cavity 1011, and the proximal end of the inclined cavity 1013 connects to the distal end of the arc-shaped transition cavity 1012. The distal end of the inclined cavity 1013 extends through the side wall of the body 1 to form a needle outlet 103. By using an arc-shaped transition cavity to connect the axially extending cavity and the inclined cavity, the first cavity 101 has a guiding function, which can limit the puncture trajectory of the needle body 2, facilitate the smooth withdrawal of the needle body 2, and avoid deviation in the withdrawal direction. In addition, in this embodiment, the inner diameters of each cavity segment of the first cavity 101 can be equal or unequal. That is, the first cavity 101 can be a cavity segment with equal diameter or a cavity segment with variable diameter. In this embodiment, a cavity segment with equal diameter is preferred.

[0071] Preferably, the distance between the needle outlet surface 104 and the axis of the axial extension cavity of the first cavity 101 is greater than the distance between the needle outlet surface 104 at the proximal end of the body 1 and the axis of the axial extension cavity. This design can make the curvature of the arc transition cavity more gradual, which is beneficial to stable needle outlet. Specifically, the radial difference between the needle outlet surface 104 and the needle outlet surface 104 at the proximal end of the body 1 is 0mm-1.0mm, preferably 0.5mm.

[0072] For needle body 2, which has a certain axial length and cross-sectional area, it is generally required to have a certain degree of flexibility and support, so that it can pass smoothly through curved blood vessels and not bend or slip during tissue puncture. The moment of inertia I of the cross section is a geometric parameter that measures the bending resistance of the cross section. The smaller the I value, the stronger the flexibility of the tube, the smaller the bending radius that can be achieved, and the stronger the adaptability to the blood vessel path. As mentioned earlier, needle body 2 is a hollow structure with a hollow circular cross section. Using the formula for the moment of inertia I of a hollow circular cross section: I=π(D^4-d^4) / 64, it can be seen that the smaller the diameter of needle body 2, the smaller the moment of inertia I, the smaller the bending radius of needle body 2, and the stronger the adaptability to the blood vessel path. However, at the same time, the support of the tube and the puncture force will be reduced accordingly. In this embodiment, to simultaneously ensure the passage of the needle body 2 through blood vessels and the puncture force on tissues, the outer diameter of the needle body 2 ranges from 0.5mm to 2.0mm, and the inner diameter ranges from 0.2mm to 1.8mm. The outer diameter of the puncture needle can be 0.5mm, 1.0mm, 1.5mm, 2.0mm, 2.5mm, etc., and the inner diameter of the needle body 2 can be 0.2mm, 0.4mm, 0.6mm, 0.8mm, 1.0mm, 1.2mm, 1.4mm, 1.6mm, 1.8mm, etc., and is not limited here. In this embodiment, the outer diameter of the needle body 2 is preferably 1.0mm, and the inner diameter is preferably 0.8mm.

[0073] Please see Figure 11 In some embodiments, for specific examples of the anti-slip structure, in addition to the toothed member 6 structure disclosed in the above embodiments, an anti-slip coating can also be used. The anti-slip coating is applied to the surface of the needle exit surface and has a certain thickness, thereby fixing and protruding from the needle exit surface 104. For example... Figure 11 As shown, the anti-slip structure is an anti-slip coating 9 coated on the needle outlet surface 104 with needle outlet 103 in the body 1. That is, at least one layer of anti-slip coating 9 is coated on the needle outlet surface 104. The anti-slip coating 9 is used to increase the static friction coefficient between the guide component and the tissue wall, thereby reducing the possibility that the needle body 2 will detach from the tissue wall due to the impact of blood flow on the body 1, and improving the adhesion stability between the guide component and the tissue wall.

[0074] As for the material of the anti-slip coating 9, it 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 the coefficient of friction of the needle surface 104 and / or surface roughness.

[0075] Furthermore, the anti-slip coating is roughened to further increase the coefficient of friction. For example, the surface of the anti-slip coating is made to have barbs, serrations, or other structures, and the height of the anti-slip structure is further increased by the shapes of the barbs, serrations, etc., so that multiple approximately columnar anti-slip structures form an anti-slip array with a certain area, and the columnar anti-slip structure disperses blood flow. With the above settings, when the guide component reaches the target contact position, the side with the anti-slip structure is placed against the tissue wall, and then the needle 2 is extended through the needle outlet 103 at the distal end of the first cavity 101 and inserted into the tissue for ablation. After ablation, the needle 2 is retracted from the needle outlet 103 at the distal end of the first cavity 101 back into the first cavity 101, and then the guide component is removed from the tissue wall, releasing the contact state.

[0076] Please see Figure 12-13 In addition to the solutions disclosed in the above embodiments, the anti-slip structure can also be implemented by directly fixing the protrusion 10 on the needle outlet surface 104, as described in the following example. Figure 12 and Figure 13 The anti-slip structure consists of several protrusions evenly distributed on the needle outlet surface 104. By designing multiple protrusions 10 on the needle outlet surface 104, the roughness of the needle outlet surface 104 is increased, thereby increasing the coefficient of friction and achieving the purpose of improving the contact stability.

[0077] In this embodiment, the specific structure of the protrusion 10 can be barbed, serrated, or similar. Preferably, the anti-slip feature is designed as a toothed structure. Common toothed shapes include triangular teeth and trapezoidal teeth. In this example, an equilateral triangular toothed shape is preferred. This facilitates the guide component to adhere to the tissue wall, increases the adhesion strength with the tissue wall, and makes the needle body 2 more accurate and stable for needle insertion. In addition, the toothed shape of the anti-slip structure is sharpened to remove sharp corners and reduce tissue damage during movement within the body.

[0078] See Figure 14Based on the above embodiments, this embodiment provides an ablation device, including a delivery component 11, an ablation component 12, and the aforementioned guide component. The delivery component includes a guide sheath with a hollow inner cavity and a bending sheath 1101. The bending sheath 1101 is movably disposed within the guide sheath. The guide component is movably disposed within the bending sheath 1101 and can move axially and circumferentially within the hollow inner cavity of the bending sheath 1101. Specifically, the catheter of the guide component is disposed within the bending sheath 1101, and the body 1 of the guide component can extend from the distal end of the bending sheath 1101 and abut against the tissue wall. The ablation component 12 includes a needle body 2 and a connector (not shown). The needle body 2 is movably installed within the first cavity 101 of the guide component, and the distal end of the needle body 2 can extend beyond the distal end of the first cavity 101 of the guide component. By adjusting the position of the first cavity 101, the needle body 2 can be driven to point to and insert into different positions of the tissue to perform tissue ablation operations. The distal end of the connector is bonded and fixed to the proximal end of the needle body 2. The proximal end of the connector is connected to the radio frequency device and the liquid infusion device through a thread. Radio frequency energy and liquid are conducted to the needle body 2 through the connector.

[0079] Furthermore, the specific structure of the guidance component can be referred to in the above embodiments, and will not be elaborated here.

[0080] Furthermore, the aforementioned ablation system also includes a mapping device, which is connected to the guiding assembly via a wire. At least one electrode may be disposed on the side wall of the main body 1, or the guiding assembly may be at least partially made of a conductive material (such as metal), with a wire embedded in the wall of the conduit, the distal end of the wire connected to the conductive part of the electrode or the guiding assembly, and the proximal end of the wire connected to the mapping system.

[0081] See Figure 15 and Figure 16 Based on the above embodiments, this embodiment proposes an ablation system, including an ablation energy generating device 13 and the aforementioned ablation device. The ablation energy generating device 13 is connected to the ablation device and is configured to provide energy to the ablation device so that the needle body 2 can perform tissue ablation. Furthermore, the ablation system also includes a perfusion device 14, which provides perfusion fluid to the ablation device. The perfusion fluid flows through the inner cavity of the needle body 2. Specific details regarding adjusting the direction of the needle body 2 can be found in US5558673A and US5370675A, and specific details regarding adjusting the bending sheath can be found in CN110215593A and CN214286246U, and will not be repeated here.

[0082] Taking the femoral artery puncture, through the aortic arch to the left ventricle, and the radiofrequency ablation of the aortic outflow tract as an example, the working process of the ablation system provided in this application is described as follows:

[0083] like Figure 15As shown, a channel from outside the body to inside is first established by the guide sheath and guide wire of the ablation device. Then, the bending sheath 1101 is inserted into the descending aorta and adjusted according to the shape of the aortic arch and the ascending aorta. When the distal end of the bending sheath 1101 is in the ascending aorta and close to the aortic valve, the bending sheath 1101 is positioned. Then, the guide assembly extends out from its distal opening through the bending sheath and is adjusted to cross the aortic valve.

[0084] like Figure 16 As shown, the guide component is adjusted to the target position and brought into contact with the target tissue wall. In some embodiments, the needle exit surface 104 of the guide component has an anti-slip structure that does not require adjustment, allowing the guide component to directly contact the needle exit surface 104 with the target tissue wall. In some embodiments, the anti-slip structure is adjusted on the needle exit surface 104 of the guide component before it is brought into contact with the target tissue wall. In some embodiments, the needle exit surface 104 of the guide component is first brought into contact with the target tissue wall, and then the anti-slip structure is adjusted on the needle exit surface 104 of the guide component.

[0085] Once the guiding component is stably attached to the target tissue wall, the driving needle 2 is used to puncture the target tissue, and then the target tissue is ablated through the energy transmission of the ablation energy generating device 13. After the ablation is completed, the needle 2, the anti-slip structure of the guiding component (if necessary), the bending sheath, and the guiding sheath are withdrawn in sequence.

[0086] Furthermore, the specific structure of the ablation device can be referred to in the above embodiments, and will not be elaborated here.

[0087] Based on the above-described guide component embodiment, this embodiment provides an injection device, including the aforementioned guide component, delivery component, and injection component. The delivery component includes a guide sheath and a bending sheath, the bending sheath being movably inserted within the guide sheath. The guide component is disposed within the bending sheath, with its proximal end connected to the distal end of the catheter. The injection component includes an injection needle, which is movably disposed within the first cavity of the guide component. This configuration allows the injection component to exit through the needle outlet of the guide component. Simultaneously, due to the anti-slip structure on the needle outlet surface, the needle outlet surface is tightly fitted against the target tissue wall. After the driving needle body punctures the target tissue, the hydrogel or other medication is injected into the target tissue to complete the treatment. It is understood that the handle 15 also has an injection section 16, which is connected to the catheter and the injection component. When the guiding component is inserted into the body through the catheter and reaches the target position, the guiding component is placed against the target tissue wall. After the guiding component is stably against the target tissue wall, the handle 15 is driven to make the needle body puncture the target tissue. Then, hydrogel or other drug solutions are injected into the injection section 16 to inject it into the target tissue. After the injection is completed, the needle body 2, the anti-slip structure of the guiding component (if necessary), the bending sheath, etc. are withdrawn in sequence.

[0088] Furthermore, the specific structure of the guidance component can be referred to in the above embodiments, and will not be elaborated here.

[0089] The technical means disclosed in this invention are not limited to those disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications are also considered within the scope of protection of this invention.

Claims

1. A guiding assembly for guiding a needle body, characterized in that, The device includes a body, which has a first cavity for the needle to pass through. The side wall of the body is provided with a needle outlet surface. The distal end of the first cavity is provided with a needle outlet on the needle outlet surface. The guide assembly also includes an anti-slip array, which includes multiple anti-slip structures. The anti-slip structure protrudes movably from the needle outlet surface; The anti-slip structure includes a toothed component, and the side wall is provided with a through hole corresponding to the toothed component. The toothed component protrudes from the needle outlet surface or retracts into the body through the through hole.

2. The guiding component according to claim 1, characterized in that, The number of columns in the anti-slip array is greater than or equal to 2, and the number of rows in the anti-slip array is greater than or equal to 2.

3. The guiding component according to claim 2, characterized in that, The ratio of the area of ​​the anti-slip array to the area of ​​the needle outlet surface is greater than or equal to 20%.

4. The guiding component according to claim 3, characterized in that, The length of the anti-slip array ranges from 3 to 5 mm, and the width of the anti-slip array ranges from 5 to 15 mm.

5. The guiding component according to claim 1, characterized in that, The anti-slip structure includes an anti-slip coating, which is at least partially applied to the needle outlet surface.

6. The guiding component according to claim 5, characterized in that, The surface roughness of the anti-slip coating is greater than the surface roughness of the needle-out surface.

7. The guiding component according to claim 1, characterized in that, The body further includes a second cavity; the anti-slip structure further includes a sliding member; the sliding member is disposed in the second cavity and can move axially within the second cavity; The toothed component is movably mounted on the sliding component.

8. The guiding component according to claim 7, characterized in that, The toothed component has an inclined surface at one end protruding from the needle outlet surface, and the inclined surface forms an angle with the needle outlet surface; the other end of the toothed component is connected to the sliding component through an elastic element; The sidewall edge of the perforation presses against the bevel to retract the toothed member into the slider.

9. The guiding component according to claim 8, characterized in that, The sliding member includes a slider, on which at least one fixing member is detachably provided; the toothed member is disposed on the fixing member via the elastic member.

10. The guiding component according to any one of claims 7-9, characterized in that, The sliding member has an axially penetrating channel, which communicates with the second cavity.

11. The guiding component according to any one of claims 1 to 9, characterized in that, The angle between the axial direction of the needle outlet and the needle outlet surface ranges from 0° to 90°.

12. The guiding component according to any one of claims 1 to 9, characterized in that, The guiding assembly also includes a catheter and a handle, the guiding assembly being disposed at the distal end of the catheter and the handle being disposed at the proximal end of the catheter.

13. An ablation device, characterized in that, Includes a delivery assembly, an ablation assembly, and a guiding assembly as described in any one of claims 1-12; The conveying assembly includes a guide sheath and a bending sheath, the bending sheath being movably inserted into the guide sheath, and the guide assembly being disposed within the bending sheath; The ablation assembly includes an ablation needle, which is movably mounted within the first cavity of the guide assembly.

14. An ablation system, characterized in that, It includes an ablation energy generating device and an ablation device as described in claim 13; the ablation energy generating device is connected to the ablation device and provides ablation energy to the ablation device.

15. The ablation system according to claim 14, characterized in that: The ablation system also includes a perfusion device for providing perfusion fluid to the ablation device, the perfusion fluid flowing through the inner cavity of the ablation needle.

16. The ablation system according to claim 14, characterized in that: The ablation system also includes a mapping device, which is connected to the guiding assembly via wires.

17. The ablation system according to claim 16, characterized in that, At least one electrode is disposed on the side wall, and the wire is disposed inside the wall of the conduit, with the distal end of the wire connected to the electrode.

18. The ablation system according to claim 17, characterized in that, The guiding assembly is at least partially made of a conductive material, the wire is disposed inside the wall of the conduit, and the distal end of the wire is connected to the guiding assembly.

19. An injection device, characterized in that, Includes a delivery assembly, an injection assembly, and a guide assembly as described in any one of claims 1-12; The conveying assembly includes a guide sheath and a bending sheath, the bending sheath being movably inserted into the guide sheath, and the guide assembly being disposed within the bending sheath; The injection assembly includes an injection needle, which is movably disposed within the first cavity of the guide assembly.

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