CN114652429A - Transcatheter cardiac muscle ablation device and transcatheter cardiac muscle ablation system - Google Patents
Transcatheter cardiac muscle ablation device and transcatheter cardiac muscle ablation system Download PDFInfo
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Abstract
The invention provides a transcatheter myocardial ablation device and a transcatheter myocardial ablation system, wherein the ablation device comprises a delivery tube body assembly and an ablation assembly, the delivery tube body assembly comprises an adjustable bending sheath tube and an adjustable bending catheter movably arranged in the adjustable bending sheath tube in a penetrating way, the adjustable bending sheath tube comprises a first bending adjusting section positioned at the far end, the adjustable bending catheter comprises a second bending adjusting section positioned at the far end, the second bending adjusting section extends out of the far end of the first bending adjusting section, the first bending adjusting section is bent along a first direction, the second bending adjusting section is bent along a second direction, the first direction is different from the second direction, the ablation assembly comprises an ablation needle movably arranged in the adjustable bending catheter in a penetrating way, the far end of the ablation needle can extend out of the far end of the adjustable bending catheter, and the pointing direction of the ablation needle is adjusted by bending the first bending adjusting section and/or the second bending adjusting section. The invention drives the ablation needle to different ablation point positions by adjusting the bending direction and the bending angle of the adjustable bending sheath tube and the adjustable bending catheter, thereby realizing ablation with low trauma, high controllability and multiple point positions.
Description
Technical Field
The application relates to the field of medical equipment and instruments, in particular to a transcatheter myocardial ablation device and a transcatheter myocardial ablation system comprising the same.
Background
Hypertrophic cardiomyopathy is a common autosomal dominant cardiovascular disease with an incidence rate of about 1: 500, fatality rates of about 1.4% to 2.2%, are the most common cause of sudden death in young people and athletes. Hypertrophic cardiomyopathy is mainly characterized by hypertrophy of one or more segments of the left ventricle, with a typical diagnostic standard of greater than or equal to 15mm thickness. When the anterior mitral leaflet moves forward to abut against the ventricular septum in the systolic period, the left ventricular outflow tract is narrowed or even blocked, namely, the left ventricular outflow tract has excessive pressure difference, so the heart disease is called obstructive hypertrophic cardiomyopathy.
At present, the treatment strategy for obstructive hypertrophic cardiomyopathy is to enlarge the left ventricular outflow tract to reduce the pressure difference and relieve the obstruction, and the commonly used treatment methods mainly comprise drug treatment, rotary ventricular septal ablation and ventricular septal alcohol ablation, but the methods have the defects of high surgical risk, poor treatment effect and the like.
In recent years, some new technologies for treating obstructive hypertrophic cardiomyopathy have been disclosed, such as performing radiofrequency ablation by using a radiofrequency ablation needle through a cardiac apical path into the myocardium, or performing radiofrequency ablation by using a radiofrequency ablation electrode through a vascular path into the heart cavity, although these methods have certain advantages compared with the conventional methods, these ablation devices with radiofrequency ablation have large trauma during ablation operation, low controllability, and inability to accurately realize multi-point ablation.
Disclosure of Invention
The invention aims to provide a transcatheter myocardial ablation device capable of adjusting ablation positions to accurately realize multi-point ablation, and a transcatheter myocardial ablation system comprising the same.
In order to solve the technical problems, the invention provides a transcatheter myocardial ablation device which comprises a delivery pipe body assembly and an ablation assembly. The conveying pipe body assembly comprises an adjustable bending sheath pipe and an adjustable bending guide pipe which is movably arranged in the adjustable bending sheath pipe in a penetrating mode, the adjustable bending sheath pipe comprises a first bending adjusting section located at the far end, the adjustable bending guide pipe comprises a second bending adjusting section located at the far end, the second bending adjusting section extends out of the far end of the first bending adjusting section, the first bending adjusting section is bent along a first direction, the second bending adjusting section is bent along a second direction, and the first direction is different from the second direction; the ablation assembly comprises an ablation needle movably arranged in the adjustable bending catheter in a penetrating mode, the far end of the ablation needle can extend out of the far end of the adjustable bending catheter, and the pointing direction of the ablation needle is adjusted by bending the first bending adjusting section and/or the second bending adjusting section.
In some embodiments, the first direction is opposite to the second direction.
In some embodiments, the transcatheter myocardial ablation device is used for ablating ventricular septum, and when the delivery tube assembly is positioned at the aortic arch part, the first bending adjusting section and/or the second bending adjusting section are bent to drive the ablation needle to point to different positions of the ventricular septum.
In some embodiments, the first direction is a direction proximal to an inner side of an aortic arch, and the second direction is a direction toward an outer side of the aortic arch.
In some embodiments, the bendable sheath further comprises a first positioning section located at the proximal end of the first bending section, and an angle between a distal tangent of the first positioning section and a distal tangent of the first bending section ranges from 0 ° to 180 °.
In some embodiments, the bending-adjustable catheter further comprises a second positioning section located at the proximal end of the second bending-adjustable section, and an included angle between a tangent at the distal end of the second positioning section and a tangent at the distal end of the second bending-adjustable section ranges from 0 ° to 90 °.
In some embodiments, the first positioning segment has a curvature substantially corresponding to a curvature of the aortic arch and the second positioning segment has a curvature substantially corresponding to a curvature of the aortic arch when the ablation needle is directed toward the ventricular septum.
In some embodiments, the delivery tube assembly further comprises a first pulling wire and a second pulling wire, the first pulling wire is disposed through the adjustable bending sheath at a position inside the bending position close to the first bending section, the distal end of the first pulling wire is connected to the distal end of the adjustable bending sheath, the first pulling wire pulls the adjustable bending sheath to bend along a first direction, the second pulling wire is disposed through the adjustable bending catheter at a position inside the bending position close to the second bending section, the distal end of the second pulling wire is connected to the distal end of the adjustable bending catheter, and the second pulling wire pulls the adjustable bending catheter to bend along a second direction. In some embodiments, the adjustable bending catheter further comprises a limiting member connected to the distal end of the second bending adjustment section, the limiting member having a rounded distal end surface.
In some embodiments, the ablation needle includes a needle assembly, a main tube and a liquid inlet tube, the needle assembly includes a needle, a straight ablation portion, a flexible reinforcement portion and a conductive portion, a distal end of the straight ablation portion is connected to a proximal end of the needle, a proximal end of the straight ablation portion is connected to a distal end of the flexible reinforcement portion, the conductive portion is disposed at a proximal end of the flexible reinforcement portion, the main tube is made of an insulating material, the main tube is sleeved with the flexible reinforcement portion and connected to the main tube, the liquid inlet tube axially penetrates the main tube and the needle assembly, and the liquid inlet tube is used for conveying a cooling medium to cool the needle assembly.
In some embodiments, the needle has a hollow lumen communicating with the lumen of the main tube, the needle being selected from at least one of a trigonal pyramid head, a beveled edge head, or a conical cusp head.
In some embodiments, the straight ablation part and the flexible reinforcement part are the same tube body, or are formed by connecting different tube bodies, and the inner cavity of the straight ablation part is communicated with the hollow inner cavity of the needle head.
In some embodiments, the flexible reinforcement is cut using a hypotube.
In some embodiments, the ablation needle further comprises a temperature sensor coupled to the ablation needle, the temperature sensor configured to measure a temperature of the ablation needle.
The invention also provides a transcatheter myocardial ablation system, which comprises an energy generator, a cooling circulation device and the transcatheter myocardial ablation device, wherein the energy generator provides energy for the transcatheter myocardial ablation system, the cooling circulation device is used for dissipating heat of the ablation needle, and the energy generator and the cooling circulation device are respectively connected with the transcatheter myocardial ablation device.
In some embodiments, the cooling circulation device includes a cooling medium reservoir for storing a cooling medium, a cooling medium collection tank for recovering the used cooling medium, a circulation pump for delivering the cooling medium from the cooling medium reservoir to the inside of the ablation needle through an inflow tube connected to the circulation pump at a proximal end thereof, the inflow tube connected to the transcatheter myocardial ablation device at a distal end thereof, the outflow tube connected to the cooling medium collection tank at a proximal end thereof, and an outflow tube connected to the transcatheter myocardial ablation device at a distal end thereof.
According to the transcatheter myocardial ablation device and the transcatheter myocardial ablation system, the ablation needle can be driven to different ablation point positions by adjusting the bending directions and angles of the adjustable bending sheath tube and the adjustable bending catheter in the delivery tube body assembly, so that the technical effects of low trauma, high controllability, accuracy and multipoint ablation in ablation operation are realized.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic structural view of a transcatheter myocardial ablation device provided by the present invention adapted to an interior portion of a heart;
FIG. 2 is a schematic view of the delivery tube assembly of FIG. 1 fitted in a body;
FIG. 3 is a schematic view of the conveying tube assembly of FIG. 2;
FIG. 4 is a schematic structural view of the adjustable bending sheath of FIG. 3;
FIG. 5 is a schematic structural view of the adjustable bend catheter of FIG. 3;
FIG. 6 is a partial cross-sectional view of the adjustable bend catheter of FIG. 5;
FIG. 7 is a cross-sectional view of the adjustable bend catheter of FIG. 5 after insertion of an ablation needle;
FIG. 8 is a cross-sectional view of the ablation needle of FIG. 7 after it has been extended out of the adjustable bend catheter;
FIG. 9 is a schematic structural view of the ablation needle of FIG. 1;
FIG. 10 is a cross-sectional view of the ablation needle of FIG. 9;
FIG. 11 is a schematic view of another embodiment of a tip of the ablation needle of FIG. 9;
FIG. 12 is a cross-sectional view of another embodiment of the ablation needle of FIG. 1;
FIG. 13 is a schematic structural view of a transcatheter myocardial ablation system provided in accordance with the present invention;
FIGS. 14-16 are schematic illustrations of a procedure for using the transcatheter myocardial ablation system provided by the present invention;
FIG. 17 is a schematic view of an application scenario of the adjustable bend catheter of FIG. 13 in which the adjustable bend ablation needle selects a different puncture site;
FIG. 18 is a schematic illustration of the ablation needle of the transcatheter myocardial ablation device of FIG. 17 selecting different puncture sites on the ventricular septum.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.
Reference throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular elements, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
Furthermore, the following description of the various embodiments refers to the accompanying drawings for illustrating the specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "top," "bottom," "front," "back," "left," "right," "inner," "outer," "side," and the like, refer to the orientation of the appended drawings and are therefore used in a better and clearer sense of description and understanding of the present invention rather than to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and is therefore not to be considered limiting of the invention.
In the description of the present invention, it should be noted that unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "disposed at … …" are to be construed broadly, e.g., as being fixedly connected, detachably connected, or integrally connected; may be a mechanical connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. In the field of accessing medical instruments, a proximal end refers to the end closer to an operator, and a distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Referring to fig. 1 to 5, the present invention provides a transcatheter myocardial ablation device including a delivery tube assembly for adjusting an ablation position and an ablation assembly for myocardial ablation. Specifically, the conveying pipe assembly includes an adjustable curved sheath 20 and an adjustable curved guide pipe 30, and the adjustable curved guide pipe 30 is movably disposed in the adjustable curved sheath 20.
The adjustable bending sheath tube 20 comprises a first bending adjusting section 21 positioned at the far end, the adjustable bending catheter 30 comprises a second bending adjusting section 31 positioned at the far end, the second bending adjusting section 31 can axially extend out of the far end of the first bending adjusting section 21, the first bending adjusting section 21 can be bent along a first direction A, the second bending adjusting section 31 can be bent along a second direction B, and the first direction A is different from the second direction B; the ablation assembly comprises an ablation needle 40 movably arranged in the adjustable bent catheter 30 in a penetrating mode, and the far end of the ablation needle 40 can axially extend out of the far end of the adjustable bent catheter 30; the first bending section 21 and/or the second bending section 31 are bent to adjust the pointing direction of the ablation needle 40. The ablation needle can be driven to different ablation point positions through the cooperation of the adjustable bending sheath tube and the adjustable bending catheter, so that target myocardial tissue is ablated, the operation process of the myocardial ablation operation is flexible and controllable, the operation wound is low, the ablation is accurate and multi-point, and the operation speed is accelerated. In this embodiment, the transcatheter myocardial ablation device employs a path through the aortic arch to ablate the ventricular septum 10, such that when the delivery tube assembly is positioned at the aortic arch, the first bending adjustment segment and/or the second bending adjustment segment is bent to drive the ablation needle to point and insert into different positions of the ventricular septum 10. It will be appreciated that the transcatheter myocardial ablation device may take other routes into the heart chamber and ablate myocardial tissue at different locations as desired.
The central axis of the sheath tube 20 and the central axis of the bending-adjustable catheter 30 are consistent, that is, the central axes of the two coincide. It is understood that in other embodiments, the central axis of the flexible sheath 20 and the central axis of the flexible catheter 30 may be co-directional and non-coincident, for example, the flexible sheath 20 may be a multi-lumen tube having a plurality of axially extending lumens, and the flexible catheter 30 may be disposed in one of the lumens, with the central axes of the two being non-coincident.
The included angle between the first direction A and the second direction B is larger than 0 degrees and smaller than 360 degrees, so that the range of point positions which can be selected in the process of bending the first bending adjusting section 21 and/or the second bending adjusting section 31 is wider, and the flexibility of the myocardial ablation operation in the operation process is increased. Preferably, the first direction a is directed opposite to the second direction B, i.e. the angle between the first direction a and the second direction B is 180 °.
Referring to fig. 4, the adjustable bending sheath 20 is a tube with a hollow inner cavity, and the adjustable bending sheath 20 further includes a first positioning section 22 and a first supporting section 23. The proximal end of the first bending section 21 is connected with the distal end of the first positioning section 22, and the proximal end of the first positioning section 22 is connected with the distal end of the first supporting section 23. In an operating state, the positions of the proximal end and the distal end of the first positioning section 22 are matched with the positions of the beginning and the end of the aortic arch part, the curvature of the first positioning section 22 is substantially consistent with the curvature of the aortic arch part, so as to ensure that the first positioning section 22 can more smoothly pass through the aortic arch part and reach a specified position, and after the adjustable bending sheath 20 reaches the specified position, the first positioning section 22 can keep good continuous contact with the aortic arch part in a bending state, so that the first positioning section 22 can be fixed at the position of the aortic arch part, and adverse effects on the operation caused by the movement of the adjustable bending sheath 20 are reduced as much as possible. In order to ensure that the first positioning section 22 has good deformation performance and can keep good shape memory after deformation, the hardness of the material for manufacturing the first positioning section 22 is preferably 55-65D. In order to ensure that the angle of the first bending adjusting section 21 is controllable during bending adjustment, and the first positioning section 22 is not driven to bend greatly during bending adjustment, the material hardness of the first bending adjusting section 21 should be less than that of the first positioning section 22. The first supporting section 23 mainly plays a role of supporting the first bending adjusting section 21 and the first positioning section 22, and in order to ensure that the first positioning section 22 does not drive the first supporting section 23 to bend greatly in the bending process, the material hardness of the first supporting section 23 should be greater than that of the first positioning section 22.
In some embodiments, the bendable sheath 20 is a composite woven mesh tube structure, which has good flexibility, pushing performance, and twisting control performance, and can maintain high bending resistance.
The sheath 20 further includes a first pulling wire (not shown) movably disposed in the outer circumferential wall of the sheath 20 along the axial direction of the sheath 20, a distal end of the first pulling wire is connected to a distal end of the first bending section 21, and a proximal end of the first pulling wire is connected to a control handle 50 (see fig. 13). Specifically, a channel tube is arranged in the outer peripheral wall of the adjustable bending sheath tube 20, the channel tube extends along the axial direction of the adjustable bending sheath tube 20, the distal end of the channel tube extends to the distal end of the first bending adjusting section 21, the proximal end of the channel tube extends to the proximal end of the first support section 23, and the first traction wire is movably arranged in the channel tube in a penetrating manner; in some embodiments, a guide groove may be directly formed on the outer circumferential wall of the adjustable bending sheath 20, the guide groove extends along the axial direction of the adjustable bending sheath 20, a distal end of the guide groove extends to a distal end of the first bending section 21, a proximal end of the guide groove extends to a proximal end of the first support section 23, and the first pull wire is movably disposed in the guide groove. The control handle 50 adjusts the bending direction of the first bending adjusting section 21 by controlling the first traction wire to move along the axial direction. In the working process, the bending direction of the first bending adjusting section 21 is a first direction a, and the first direction a is a direction close to the inner side of the aortic arch part. The ability of the first bend-adjusting section 21 to bend in the first direction a ensures that the distal end of the first bend-adjusting section 21 can be closer to or farther from the ventricular septum 10, facilitating subsequent selection of different ablation sites. In the bending process of the first bending adjusting section 21, the included angle between the far end tangent of the first bending adjusting section 21 and the far end tangent of the first positioning section 22 ranges from 0 degree to 180 degrees. In some embodiments, in order to prevent the adjustable bending sheath 20 from twisting due to the fact that the pulling direction of the first pulling wire is not consistent with the bending direction of the first bending adjusting section 21, the first pulling wire should be inserted into the bending inner side position of the adjustable bending sheath 20 close to the first bending adjusting section 21, that is, the channel pipe or the guide groove should be located at the bending inner side position of the first bending adjusting section 21, so as to ensure the stability of the force direction of the adjustable bending sheath 20 during the working process.
Referring to fig. 5, the adjustable bending catheter 30 is a tube with a hollow inner cavity, and the adjustable bending catheter 30 further includes a second positioning section 32 and a second supporting section 33. The proximal end of the second bending section 31 is connected to the distal end of the second positioning section 32, and the proximal end of the second positioning section 32 is connected to the distal end of the second supporting section 33. The bending curvature of the second positioning section 32 is substantially the same as the bending curvature of the aortic arch, so that the flexible catheter 30 and the flexible sheath 20 have good adaptability in bending form, and the two are prevented from interfering with each other. In order to ensure that the angle of the second bending adjusting section 31 is controllable in the bending adjusting process, and the second positioning section 32 is not driven to be bent greatly in the bending adjusting process, the material hardness of the second bending adjusting section 31 should be less than that of the second positioning section 32. The second supporting section 33 is mainly used for supporting the second bending section 31 and the second positioning section 32, and in order to ensure that the second positioning section 32 does not drive the second supporting section 33 to bend greatly in the bending process, the material hardness of the second positioning section 32 should be less than that of the second supporting section 33. In order to ensure that the second bending adjusting section 31 does not simultaneously drive the first bending adjusting section 21 to bend greatly in the bending adjusting process, the material hardness of the second bending adjusting section 31 should be less than that of the first bending adjusting section 21.
The bendable catheter 30 further comprises a second pulling wire (not shown) movably arranged in the outer circumferential wall of the bendable catheter 30 along the axial direction of the bendable catheter 30, wherein the distal end of the second pulling wire is connected with the distal end of the second bendable section 31, and the proximal end of the second pulling wire is connected with the control handle 50. Specifically, a channel tube is arranged in the peripheral wall of the adjustable bending catheter 30, the channel tube extends along the axial direction of the adjustable bending catheter 30, the distal end of the channel tube extends to the distal end of the second bending section 31, the proximal end of the channel tube extends to the proximal end of the second supporting section 33, and the second pull wire is movably arranged in the channel tube; in some embodiments, a guide groove may be directly formed on the outer circumferential wall of the adjustable bending catheter 30, the guide groove extends along the axial direction of the adjustable bending catheter 30, the guide groove extends to the distal end of the second bending section 31, the proximal end of the guide groove extends to the proximal end of the second support section 33, and the second pull wire is movably disposed in the guide groove. The manipulating handle 50 adjusts the bending of the second bending adjustment section 31 by controlling the second traction wire to move in the axial direction. Meanwhile, in order to adapt to the bending direction of the second bending adjusting section 31, the second traction wire should be inserted into the bending inner side position of the adjustable bending guide tube 30 close to the second bending adjusting section 31, that is, the guide tube or the guide groove should be located at the bending inner side position of the second bending adjusting section 31. In the working process, the bending direction of the second bending adjusting section 31 is a second direction B, and the second direction B is the direction of the aortic arch part towards the outer side of the arch part. The second bending section 31 can be bent in the second direction B, so that the distal end of the second bending section 31 can be close to or far away from the ventricular septum 10, and different ablation positions can be selected conveniently. In the bending process of the second bending adjusting section 31, an included angle C between a far-end tangent of the second bending adjusting section 31 and a far-end tangent of the second positioning section 32 ranges from 0 ° to 90 °, and preferably, the included angle C between the far-end tangent of the second bending adjusting section 31 and the far-end tangent of the second positioning section 32 is 45 °.
Referring to fig. 6 to 8, the adjustable bending catheter 30 further includes a limiting member 34, the limiting member 34 is disposed at a distal end of the second bending section 31, during a specific working process, the second bending section 31 is bent toward the second direction B and approaches the ventricular septum 10, and then the limiting member 34 is tightly attached to an outer membrane of the ventricular septum 10 to provide a supporting force for the ablation needle 40 to puncture the outer membrane of the ventricular septum 10, and meanwhile, it is ensured that the ablation needle 40 does not move to a large extent during the puncturing process, thereby ensuring that the puncture site can be accurately controlled. The limiting member 34 has a smooth distal end surface to avoid damaging the inner wall of the adjustable curved sheath 20 and the heart tissue such as endocardium and valve of the human body. The stop 34 may be a hemisphere disposed at the distal end of the adjustable bending catheter 30, the spherical surface of the hemisphere being disposed in a direction away from the distal end surface of the second adjustable bending section 31. In this embodiment, the limiting member 34 is a boss, the outer diameter of the far end of the boss is larger than the outer diameter of the near end of the boss, the near end of the boss is embedded into the inner cavity 311 of the second bending adjusting section 31, the fixing manner includes but is not limited to bonding and welding, and the near end of the boss can be further processed by sand blasting, hollowing, punching, grooving and the like to increase the firmness of connection with the inner cavity 311. The retaining member 34 includes a central through hole 341 extending completely through the axial direction, the central through hole 341 is connected to the inner cavity 311, a diameter D1 of the central through hole 341 should be smaller than a diameter D2 of the inner cavity 311, and a maximum outer diameter D3 (see fig. 10) of the ablation needle 40 should be smaller than a diameter D1 of the central through hole 341, so as to ensure that the distal end of the ablation needle 40 located in the inner cavity 311 can extend out of the distal end of the retaining member 34 through the central through hole 341. The position limiting member 34 is made of a material including, but not limited to, stainless steel, polyoxymethylene, polycarbonate, etc., and is machined or injection-molded.
Referring to fig. 7 to 10, the ablation needle 40 includes a needle assembly 41, a main tube 42, a temperature sensor 43 and an inlet tube 44. Specifically, the needle assembly 41 includes a needle 411, a straight ablation portion 412, a flexible reinforcement portion 413, a conductive portion 414, and a lumen 415. The proximal end of the needle 411 is connected with the distal end of the straight ablation part 412, the proximal end of the needle 411 is in a boss shape, the boss part is embedded into the inner cavity 415 in the straight ablation part 412, and preferably, the proximal end of the needle is fixedly connected in a laser welding mode; the proximal end of the flat ablation portion 412 is connected to the distal end of the flexible reinforcement portion 413 such that the connection between the needle assembly 41 and the main tube 42 is a gradual transition, and the conductive portion 414 is disposed at the proximal end of the flexible reinforcement portion 413. The straight ablation part 412, the flexible reinforcing part 413 and the conductive part 414 may be formed by machining the same whole metal circular tube, or may be formed by connecting two different metal circular tubes by a fixing method such as welding, preferably by laser welding. In this embodiment, the straight ablation portion 412, the flexible reinforcing portion 413 and the conductive portion 414 are formed by cutting the same integral metal circular tube by laser cutting. The needle assembly 41 is made of a metal material with good electrical conductivity, which can realize electrical conductivity, and preferably, the needle assembly 41 is made of a stainless steel material.
Referring to fig. 10, the distal end of the needle 411 is closed, the proximal end of the needle 411 has a hollow inner cavity 4111, the inner cavity 4111 is communicated with the inner cavity 415 of the needle assembly 41, and the temperature sensor 43 can extend into the inner cavity 4111, so that the temperature sensor 43 can more accurately measure the temperature of the distal end of the needle assembly 41, the precision of temperature measurement is improved, the error of temperature measurement is reduced, meanwhile, the cooling liquid can enter the inner cavity 4111, the heat dissipation efficiency of the needle 411 is improved, the ablation efficiency in the ablation process is improved, and the possibility of scabbing at the ablation part is reduced. Optionally, the surface of needle 411 may be coated with a gold coating or other radiopaque coating material to enhance visualization of needle 411 under CT. The distal end of the needle 411 has a sharp tip, and the needle 411 is preferably a triangular pyramid head. Referring to fig. 11, in some embodiments, the needle 411 may also be a beveled cutting head 411b or a conical pointed head 411 c.
Referring to fig. 9 and 10, the flexible reinforcing portion 413 may be cut by a hypotube in a form of a single-sided tube body and a four-directional tube body, and preferably, the flexible reinforcing portion 413 can be bent in a 360 ° direction by a cutting manner of the four-directional tube body. Because the connection position of the needle assembly 41 and the main tube 42 is located at the position of the second bending adjusting section 31, during the bending adjusting process of the second bending adjusting section 31, the distal end of the main tube bends along with the second bending adjusting section, and the presence of the flexible reinforcing part 413 can increase the bending resistance of the main tube 42 in the bending state, and prevent the main tube 42 from bending during the bending adjusting process of the bending adjustable catheter 30. The conductive portion 414 is used to connect the distal end of a wire (not shown), the proximal end of the wire is connected to the energy generator 60 (see fig. 13) to realize the electrical connection between the needle assembly 41 and the energy generator 60, and the conductive portion 414 can be a connecting hole or a connecting hook to increase the firmness of the connection between the wire and the conductive portion 414 and the contact quality, and the connecting hole or the connecting hook includes, but is not limited to, a round hole, a square hole, a groove, a barb, and a notch.
Referring to fig. 10, the main tube 42 is sleeved outside the flexible reinforcing portion 413, the distal end of the main tube 42 should exceed the distal end of the flexible reinforcing portion 413 to ensure that the inner cavity of the ablation needle 40 forms a closed space, and the main tube 42 and the flexible reinforcing portion 413 are preferably fixed by means of glue bonding. The main tube 42 is made of an insulating material, and should have good bending resistance, pushing performance, surface lubrication performance and bending performance, and the insulating material preferably used includes, but is not limited to, polyetheretherketone, polyimide and other polymer materials.
The temperature sensor 43 is axially disposed within the lumen 415, the distal end of the temperature sensor 43 is disposed within the lumen 4111, and the proximal end of the temperature sensor 43 passes through the steering handle 50 and is connected to the energy generator 60 via a lead. The temperature sensor 43 can monitor the temperature of the distal end of the ablation needle 40 during the ablation process, and adjust the output power/energy of the energy generator 60 through real-time temperature feedback, so as to prevent the phenomena of carbonization, scabbing and the like of myocardial tissue contacted with the distal end of the ablation needle 40, which causes the adverse effects that the ablation energy cannot be effectively diffused and the ablation range is too small. Alternatively, the temperature sensor 43 may be disposed in the inner cavity 441 of the liquid inlet pipe 44, and may be disposed outside the liquid inlet pipe 44. The temperature sensor 43 includes a thermocouple type and a thermistor type, preferably, the temperature sensor 43 is a thermocouple type, the temperature sensor 43 includes, but is not limited to, a K-type thermocouple, a T-type thermocouple, and an S-type thermocouple, and preferably, the temperature sensor 43 is a K-type thermocouple, so as to ensure high temperature measurement linearity and high sensitivity of the temperature sensor 43.
The liquid inlet pipe 44 is a hollow pipe body, and is disposed through the main pipe 42 and the needle assembly 41 for conveying a cooling medium to cool the needle assembly 41. The distal end of the liquid inlet tube 44 is close to the proximal end of the needle 411, the proximal end of the liquid inlet tube 44 passes through the control handle 50 and is connected with the distal end of the inflow tube 72 (see fig. 13), the liquid inlet tube 44 serves as an inflow channel of the cooling medium, the gap between the outer wall of the liquid inlet tube 44 and the inner cavity 415 serves as an outflow channel of the cooling medium, the outflow channel is connected with the distal end of the outflow tube 73 (see fig. 13) in the control handle 50, and the inflow channel and the outflow channel merge and meet in the inner cavity 4111.
Referring to fig. 12, in some embodiments, the structure of the ablation needle 40b is substantially the same as that of the ablation needle 40, except that the main tube 42 is sleeved inside the flexible reinforcing part 413, and the distal end of the main tube 42 should exceed the distal end of the flexible reinforcing part 413, so as to ensure that the inner cavity of the ablation needle 40b forms a closed space.
Referring to fig. 7-8, in the initial state, the ablation needle 40 is received in the inner cavity 311 of the adjustable bending catheter 30, and the distal end of the ablation needle 40 does not exceed the distal end of the stopper 34, so as to ensure that the adjustable bending catheter 30 with the ablation needle 40 does not damage the inner wall of the adjustable bending sheath 20 and the endocardium and valve of the human body during the delivery process, but the needle 411 should not completely withdraw from the central through hole 341 and enter the inner cavity 311. In the operating state, the control handle 50 can control the ablation needle 40 to extend out of the inner cavity 311 along the axial direction of the adjustable bending catheter 30.
Referring to fig. 13, the present invention further provides a transcatheter myocardial ablation system 100, wherein the transcatheter myocardial ablation system 100 includes a control handle 50, an energy generator 60, a cooling circulation device 70 and the transcatheter myocardial ablation device, the energy generator 60 provides energy for the transcatheter myocardial ablation system, the cooling circulation device 70 is used for dissipating heat from the ablation needle 40, and the energy generator 60 and the cooling circulation device 70 are respectively connected to the transcatheter myocardial ablation device.
The cooling circulation device 70 includes a circulation pump 71, an inflow pipe 72, an outflow pipe 73, a cooling medium collection tank 74, and a cooling medium reservoir 75. The circulation pump 71 is connected to the cooling medium reservoir 75 through a conduit, the inflow tube 72 has a proximal end connected to the circulation pump 71 and a distal end connected to the transcatheter myocardial ablation device, and the outflow tube 73 has a proximal end connected to the cooling medium collection tank 74 and a distal end connected to the transcatheter myocardial ablation device. Specifically, the cooling medium reservoir 75 is used to store a cooling medium; a cooling medium collection tank 74 for recovering the used cooling medium; a circulation pump 71 for delivering the cooling medium from the cooling medium reservoir 75 to the interior of the ablation needle 40 via an inflow tube 72; an inflow pipe 71 for providing a transport passage for the inflow of the cooling medium; and an outflow pipe 73 for providing a conveyance passage for the outflow of the cooling medium.
Referring to fig. 14-18, the following description will be made of the operation of the catheter-based myocardial ablation system 100, which mainly includes the following steps:
the first step is as follows: under the guidance of ultrasound or CT, the femoral artery of the patient is punctured and placed with the adjustable bent sheath 20, and the adjustable bent sheath 20 is conveyed to the position of the aortic valve close to the side of the aortic arch along the aortic arch through the guidance of a guide wire (not shown).
The second step is that: when the adjustable bending sheath 20 reaches the position of the aortic valve close to the aortic arch, the operation handle 50 is operated to convey the adjustable bending catheter 30 along the inner cavity of the adjustable bending sheath 20 to the position of the aortic valve close to the aortic arch, and the adjustable bending catheter crosses the aortic valve under the guidance of ultrasound/CT without damaging the aortic valve.
The third step: the control handle 50 is operated to bend the first bending adjusting section 21 or/and the second bending adjusting section 31, so that the distal end of the limiting member 34 can abut against the outer surface of the myocardial tissue 10 to be ablated.
The fourth step: the control handle 50 is operated to control the ablation needle 40 to extend out from the inner cavity 311 along the axial direction of the adjustable bent catheter 30, the ablation needle 40 punctures the epicardium and reaches the interior of the ventricular septum 10, and the angle and the depth of the ablation needle 40 penetrating into the target tissue are controlled under the double judgment of the ultrasonic image and the scale marks on the control handle 50.
The fifth step: after the above four steps are completed, the circulation pump 71 is started, the cooling medium circulates in the cooling circulation device 70 for several seconds, and then the energy generator 60 is started to ablate the target hypertrophic myocardial tissue through the distal end of the ablation needle 40.
And a sixth step: when the target hypertrophic myocardial tissue is ablated by the ablation needle 40 to a reasonable size, the energy generator 60 is turned off, the circulating pump 71 is turned off, and the ablation needle 40 is retracted into the inner cavity 311 along the axial direction of the adjustable bending catheter 30 through the control handle 50.
The seventh step: the manipulation handle 50 is operated to release the bending of the first bending adjustment section 21 or/and the second bending adjustment section 31, so that the distal end of the limiting member 34 is far away from the outer membrane of the ventricular septum 10. Manipulation handle 50 is then operated to select the next target puncture site on the compartment wall 10 membrane. The distal end of the flexible catheter 30 will now assume an arc of oscillation from point E to point F, with 1, 2, 3, 4 or more puncture sites being selected within the appropriate range. And when the next target puncture site is selected, repeating the operations from the third step to the sixth step until the selection, puncture and ablation of all preset point positions are completed.
Eighth step: after ablation is completed, a plurality of ablation zones are left on the thickened chamber partition 10 in a continuous manner, and the ablation zones can be connected together to form an elongated continuous ablation range.
While the foregoing is directed to the preferred embodiment of the present application, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.
Claims (16)
1. A transcatheter myocardial ablation device, comprising:
the conveying pipe body assembly comprises an adjustable bending sheath pipe and an adjustable bending guide pipe movably arranged in the adjustable bending sheath pipe in a penetrating mode, the adjustable bending sheath pipe comprises a first bending adjusting section located at the far end, the adjustable bending guide pipe comprises a second bending adjusting section located at the far end, the second bending adjusting section extends out of the far end of the first bending adjusting section, the first bending adjusting section is bent along a first direction, the second bending adjusting section is bent along a second direction, and the first direction is different from the second direction; and
the ablation assembly comprises an ablation needle movably arranged in the adjustable bent catheter in a penetrating mode, and the far end of the ablation needle can extend out of the far end of the adjustable bent catheter;
and the direction of the ablation needle is adjusted by bending the first bending adjusting section and/or the second bending adjusting section.
2. The transcatheter myocardial ablation device of claim 1, wherein the first direction is opposite to the second direction.
3. The device of claim 1, wherein the device is configured to ablate ventricular septum, and the delivery tube assembly bends the first and/or second bend-adjusting sections when positioned in the aortic arch to direct the ablation needle to different locations in the ventricular septum.
4. The transcatheter myocardial ablation device of claim 3, wherein the first direction is a direction proximal to an inner side of an aortic arch and the second direction is a direction toward an outer side of the aortic arch.
5. The transcatheter myocardial ablation device of claim 4, wherein the adjustable bending sheath further comprises a first positioning segment located proximal to the first bending segment, and an angle between a distal tangent of the first positioning segment and a distal tangent of the first bending segment ranges from 0 ° to 180 °.
6. The transcatheter myocardial ablation device according to claim 5, wherein the adjustable bending catheter further comprises a second positioning section located at a proximal end of the second bending section, and an included angle between a tangent at a distal end of the second positioning section and a tangent at a distal end of the second bending section ranges from 0 ° to 90 °.
7. The transcatheter myocardial ablation device of claim 6, wherein the first positioning segment has a curvature substantially corresponding to a curvature of the aortic arch and the second positioning segment has a curvature substantially corresponding to a curvature of the aortic arch when the ablation needle is directed toward the ventricular septum.
8. The transcatheter myocardial ablation device of claim 1, wherein the delivery tube assembly further comprises a first pull wire and a second pull wire;
the first traction wire penetrates through the position, close to the bending inner side of the first bending adjusting section, of the adjustable bending sheath tube, the distal end of the first traction wire is connected with the distal end of the adjustable bending sheath tube, and the first traction wire pulls the adjustable bending sheath tube to bend along a first direction;
the second traction wire penetrates through the position, close to the inner bending side of the second bending adjusting section, of the bending adjusting catheter, the far end of the second traction wire is connected with the far end of the bending adjusting catheter, and the second traction wire pulls the bending adjusting catheter to bend along a second direction.
9. The transcatheter myocardial ablation device of claim 1, wherein the adjustable bend catheter further comprises a stop connected to a distal end of the second adjustable bend segment, the stop having a rounded distal end surface.
10. The transcatheter myocardial ablation device of any one of claims 1-9, wherein the ablation needle comprises:
the needle head assembly comprises a needle head, a straight ablation part, a flexible reinforcing part, a conductive part and an inner cavity, wherein the near end of the needle head is connected with the far end of the straight ablation part, the near end of the straight ablation part is connected with the far end of the flexible reinforcing part, the conductive part is arranged at the near end of the flexible reinforcing part, and the inner cavity is arranged in the needle head assembly;
the main body pipe is made of an insulating material and is sleeved and connected with the flexible reinforcing part; and
the liquid inlet pipe axially penetrates through the main body pipe and the needle head assembly, and is used for conveying cooling media to cool the needle head assembly.
11. The transcatheter myocardial ablation device of claim 10, wherein the needle has a hollow lumen in communication with the lumen of the main tube, the needle being selected from at least one of a trigonal pyramid head, a beveled blade head, or a conical pointed head.
12. The transcatheter myocardial ablation device according to claim 10, wherein the straight ablation part and the flexible reinforcement part are the same tube or are formed by connecting different tubes, and the inner cavity of the straight ablation part is communicated with the hollow inner cavity of the needle.
13. The transcatheter myocardial ablation device of claim 10, wherein the flexible reinforcement is cut using a hypotube.
14. The transcatheter myocardial ablation device of claim 1, wherein the ablation needle further comprises a temperature sensor coupled to the ablation needle, the temperature sensor configured to measure a temperature of the ablation needle.
15. A transcatheter myocardial ablation system, comprising:
an energy generator, a cooling circulation device, and a transcatheter myocardial ablation device according to any one of claims 1 to 14;
the energy generator provides energy for the transcatheter myocardial ablation system, the cooling circulation device is used for radiating heat of the ablation needle, and the energy generator and the cooling circulation device are respectively connected with the transcatheter myocardial ablation device.
16. The transcatheter myocardial ablation system of claim 15, wherein the cooling circulation device comprises:
a cooling medium reservoir to store a cooling medium;
a cooling medium collection tank to recover a used cooling medium;
a circulation pump for delivering a cooling medium from the cooling medium reservoir through an inflow tube to the interior of the ablation needle;
an inflow tube, the proximal end of which is connected to the circulation pump and the distal end of which is connected to the transcatheter myocardial ablation device; and
an outflow tube, the outflow tube proximal end connected to the cooling medium collection tank, the outflow tube distal end connected to the transcatheter myocardial ablation device.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111674991.8A CN114652429A (en) | 2021-12-31 | 2021-12-31 | Transcatheter cardiac muscle ablation device and transcatheter cardiac muscle ablation system |
| PCT/CN2022/143881 WO2023125927A1 (en) | 2021-12-31 | 2022-12-30 | Ablation needle, ablation device and ablation system for myocardial ablation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111674991.8A CN114652429A (en) | 2021-12-31 | 2021-12-31 | Transcatheter cardiac muscle ablation device and transcatheter cardiac muscle ablation system |
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| CN114652429A true CN114652429A (en) | 2022-06-24 |
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| CN115137467A (en) * | 2022-07-07 | 2022-10-04 | 上海导向医疗系统有限公司 | Puncture ablation needle |
| WO2024046359A1 (en) * | 2022-08-31 | 2024-03-07 | 杭州诺沁医疗器械有限公司 | Guide assembly, ablation apparatus, and ablation system |
| WO2024046356A1 (en) * | 2022-08-31 | 2024-03-07 | 杭州诺沁医疗器械有限公司 | Ablation needle, ablation device, and ablation system |
| WO2024046350A1 (en) * | 2022-08-31 | 2024-03-07 | 杭州诺沁医疗器械有限公司 | Guide assembly, ablation device, and ablation system |
| WO2024060572A1 (en) * | 2022-09-19 | 2024-03-28 | 上海汇禾医疗科技有限公司 | Delivery sheath for interventional therapy for structural heart disease and delivery system |
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