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WO2023124180A1 - Gaine de guidage réglable, appareil d'ablation, système d'ablation et procédé d'ablation myocardique - Google Patents

Gaine de guidage réglable, appareil d'ablation, système d'ablation et procédé d'ablation myocardique Download PDF

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Publication number
WO2023124180A1
WO2023124180A1 PCT/CN2022/116388 CN2022116388W WO2023124180A1 WO 2023124180 A1 WO2023124180 A1 WO 2023124180A1 CN 2022116388 W CN2022116388 W CN 2022116388W WO 2023124180 A1 WO2023124180 A1 WO 2023124180A1
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WO
WIPO (PCT)
Prior art keywords
ablation
sheath
adjustable
pipe section
section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/116388
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English (en)
Chinese (zh)
Inventor
张庭超
丘信炯
李阳
王柏栋
庄镇平
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Nuoqin Medical Equipment Co Ltd
Original Assignee
Hangzhou Nuoqin Medical Equipment Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Hangzhou Nuoqin Medical Equipment Co Ltd filed Critical Hangzhou Nuoqin Medical Equipment Co Ltd
Priority to CN202280085779.4A priority Critical patent/CN118541185A/zh
Publication of WO2023124180A1 publication Critical patent/WO2023124180A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Definitions

  • the invention relates to the technical field of medical devices, in particular to an adjustable guide sheath, an ablation device, an ablation system and a myocardial ablation method.
  • HCM Hypertrophic Cardiomyopathy
  • LV Left Ventricle
  • the main treatment methods are: Drug therapy, Surgical septalmyectomy, Ventricular septal ablation.
  • ablation catheters are used to enter the heart cavity through blood vessels for ablation of the interventricular septum, but the existing ablation catheters have the following defects:
  • the catheter with the ablation component needs to constantly apply external force to adjust the shape of the catheter when passing through the human blood vessel path, so that it can pass through the human blood vessel path and reach a position closer to the tissue to be ablated , after the catheter reaches the above position, the ablation assembly can ablate the interventricular septum.
  • the catheter needs to maintain its own position, that is, it needs to constantly apply external force to the catheter to maintain its position.
  • the operator is It is not possible to apply external force to the catheter at all times to keep it in place during ablation therapy.
  • the patent with the notification number CN209711827U discloses an ablation needle assembly and an ablation system.
  • the ablation needle assembly includes a hollow outer sleeve and an ablation needle.
  • the outer sleeve The movable sheath is outside the main body of the ablation needle; when disassembled, the sheath needle can be used as a channel for other operations such as biopsy, which avoids repeated punctures and reduces tissue damage.
  • Percutaneous transthoracic puncture is required.
  • the ablation needle needs to pass through the skin, subcutaneous, chest cavity, pericardium, and myocardium. Tissue damage is unavoidable.
  • the coronary artery is distributed on the outside of the heart. This technique is used in puncturing the epicardium. Accidental puncture of a larger branch of a coronary artery can lead to pericardial effusion or even cardiac tamponade, which can be fatal;
  • the ablation needle used in this technology is a rigid needle, which cannot be flexibly and controllably changed to achieve the effect of multi-point ablation, which is not conducive to fully ablation of hypertrophic myocardial tissue.
  • the first object of the present invention is to provide an adjustable introducer sheath to optimize the problem that the existing introducer sheath needs external force to maintain its shape after entering the human body , improve the convenience of use.
  • the second object of the present invention is to provide an ablation device, which provides a minimally invasive treatment method for ablation of lesion tissue by puncturing the endocardium of a human heart through a catheter.
  • the third object of the present invention is to provide an ablation device to optimize the inconvenience of using the existing ablation device and improve the convenience of use.
  • the fourth object of the present invention is to provide a myocardial ablation method to optimize the inconvenience of existing myocardial ablation methods and improve treatment efficiency.
  • the present invention provides an adjustable introducer sheath, including a guide sheath and an adjustment member, and the guide sheath includes a first tube section, a second tube section and The third pipe section; in the natural state: the second pipe section first extends away from the first pipe section, and then extends towards the direction close to the first pipe section, and the third pipe section extends toward the direction close to or away from the first pipe section; the first pipe section and The second pipe section is located on the first plane, and the third pipe section is located on the first plane or on a second plane having an included angle with the first plane;
  • the natural state changes to the bending state.
  • the first pipe segment in a natural state, is straight, or its proximal end is straight and its distal end is curved.
  • the second pipe segment in a natural state, is a curve, and its middle part is arched relative to the two ends.
  • the third pipe section in a natural state, is a curve, and when extending toward the direction close to the first pipe section, the curvature of the proximal part of the third pipe section is smaller than the curvature of the distal part of the third pipe section; or, the third pipe section When the pipe section extends away from the first pipe section, the curvature of the proximal portion of the third pipe section is greater than the curvature of the distal portion of the third pipe section.
  • this embodiment proposes another adjustable introducer sheath, including a guide sheath and an adjustment member, and the guide sheath includes a first tube section that communicates sequentially from the proximal end to the distal end , the second pipe section and the third pipe section; in the natural state, the second pipe section extends away from the first pipe section, and the third pipe section extends toward the direction close to the first pipe section; the first pipe section and the second pipe section are located on the first plane, The third pipe segment is located on the first plane or on a second plane having an included angle with the first plane; the adjusting member is connected to the guiding sheath, and is used for controlling the transition of the guiding sheath from the natural state to the bending state.
  • the first pipe segment in a natural state, is straight, or its proximal end is straight and its distal end is curved.
  • the second pipe section in a natural state, is a curve, and the curvature of the proximal portion thereof is greater than the curvature of the distal portion of the second pipe section.
  • the third pipe section in a natural state, is a curve, and the curvature of the proximal portion thereof is smaller than the curvature of the distal portion of the third pipe section.
  • the curvatures of the first pipe section, the second pipe section and the third pipe section are different, the curvature of the second pipe section is greater than that of other pipe sections, and the curvature of the third pipe section is greater than that of the first pipe section.
  • the curvature of the second pipe segment is a constant value.
  • the curvature of the second tube segment first increases and then decreases from its proximal end to its distal end.
  • the angle between the first plane and the second plane is a, where 10° ⁇ a ⁇ 45°.
  • this embodiment proposes an ablation device, including a delivery assembly and an ablation assembly; the ablation assembly is movably mounted in the delivery assembly, and the ablation assembly includes an ablation needle; the delivery assembly is used for transcatheter intervention In the heart, after the ablation needle passes through the delivery assembly, it enters the myocardial tissue by puncturing the endocardium, so as to ablate the myocardial tissue.
  • the delivery assembly includes an introducer sheath and an adjustable curved sheath; the adjustable curved sheath is movably threaded in the guide sheath; and the ablation needle is movably threaded in the adjustable curved sheath.
  • the introducer sheath has a shape matching the intervening cardiac septal channel in a natural state or after being bent.
  • the introducer sheath is any one of the above adjustable introducer sheaths.
  • this embodiment proposes an ablation device, including a delivery assembly and an ablation assembly; the delivery assembly includes any of the above adjustable guide sheaths and adjustable curved sheaths; the adjustable curved sheath moves The guide sheath is threaded in the guide sheath of the adjustable guide sheath; the ablation component is movably threaded in the adjustable curved sheath; the guide sheath has a shape matching the intervening heart interventricular septal channel in a natural state.
  • the ablation assembly includes an ablation needle, and the ablation needle is used to ablate myocardial tissue.
  • the ablation needle is directed to different positions of the myocardial tissue by adjusting the distal end of the adjustable curved sheath.
  • the adjustable curved sheath includes a main body section, a shaping section and a bending section that are sequentially connected from the proximal end to the distal end.
  • the main body section is adapted to the first tube section, and the shaping section is connected to the second tube section,
  • the third pipe section is suitable; the distal end of the shaping section extends toward the first direction, and the bending section extends toward the second direction opposite to the above-mentioned first direction.
  • the ablation needle includes a needle body on which an ablation segment is at least partially disposed.
  • the needle body is a hollow tubular structure; at least one perfusion hole is arranged on the needle body, and the perfusion hole communicates with the inside of the needle body.
  • a circulation channel through which the cooling liquid circulates is provided in the ablation segment.
  • the effective ablation length of the ablation segment can be adjusted.
  • an insulating layer is arranged on the needle body, and the insulating layer is integrally arranged with the needle body.
  • the ablation segment is detachably connected to the needle body.
  • the needle body is covered with an insulating sleeve, and the insulating sleeve and the needle body can slide relative to each other.
  • the shape of the first tube segment corresponds to the shape of the descending aorta; the shape of the second tube segment corresponds to the shape of the aortic arch; the shape of the third tube segment corresponds to the shape of the ascending aorta correspond.
  • the shape of the first tube segment corresponds to the shape of the inferior vena cava; the shape of the second tube segment corresponds to the channel from the inferior vena cava to the position of the tricuspid valve in the right atrium close to the right atrium The shape corresponds; the shape of the third tube segment corresponds to the shape of the channel from the location of the tricuspid valve in the right atrium near the right atrium to the right ventricle near the interventricular septum.
  • the shape of the first tube segment corresponds to the shape of the inferior vena cava; the shape of the second tube segment corresponds to the shape of the channel from the inferior vena cava and right atrium through the interatrial septum to the left atrium Corresponding; the shape of the third tube segment corresponds to the shape of the channel from the position of the mitral valve in the left atrium close to the left atrium.
  • the myocardial tissue is the interventricular septum.
  • this embodiment provides an ablation system, including: any one of the above ablation devices; and an ablation energy generating device connected to the ablation device to provide energy for the ablation device.
  • the system further includes a perfusion device, which is used to provide liquid for the ablation device.
  • the ablation device includes an ablation needle, and at least one perfusion hole is provided on the ablation needle, or a circulation channel for fluid circulation is provided in the ablation needle.
  • this embodiment proposes a myocardial ablation method, the method including the following steps:
  • this embodiment proposes a myocardial ablation method, the method including the following steps:
  • the adjustable introducer sheath is any one of the above adjustable introducer sheaths.
  • this embodiment proposes a myocardial ablation method, which is characterized in that the method includes the following steps:
  • the adjustable introducer sheath is any one of the above adjustable introducer sheaths.
  • step S1 before inserting the adjustable introducing sheath into the path, the adjustable introducing sheath is first straightened.
  • the myocardial tissue is the interventricular septum.
  • the path for myocardial ablation is one of path a, path b, and path c;
  • Route a reach the left ventricle through the femoral artery and aortic arch;
  • Route b through the inferior vena cava, right atrium, to the right ventricle;
  • Route c through the inferior vena cava, right atrium, atrial septum, and left atrium to the left ventricle.
  • the ablation needle By adjusting the shape of the distal end of the bending sheath, the ablation needle can be directed to different positions of the myocardial tissue, which is convenient for multi-point ablation;
  • the ablation needle in the ablation system can adjust the effective length of the ablation segment according to the needs of the ablation point to meet the actual use needs.
  • FIGS. 1A-1D are schematic diagrams of the structure of the introducer sheath of the introducer sheath in one embodiment of the present invention.
  • FIG. 2 is a schematic diagram of the guiding sheath of the guiding sheath in an aortic vessel in one embodiment of the present invention
  • FIG. 3 is a schematic diagram of the guide sheath of the guide sheath adjusted in the aortic vessel in one embodiment of the present invention
  • Fig. 4 is the sectional view of M-M plane among Fig. 3;
  • Fig. 5 is a schematic diagram of the distal end of the guiding sheath close to the aortic valve in one embodiment of the present invention
  • Fig. 6 is a schematic diagram of the structure of the guide sheath of the introducer sheath in one embodiment of the present invention.
  • Fig. 7 is a schematic diagram of another perspective of Fig. 6;
  • Fig. 8 is a schematic diagram of the structure of the guiding sheath of the guiding sheath in one embodiment of the present invention.
  • Fig. 9 is a schematic diagram of the distal end of the adjustable curved sheath tube of the introducer sheath entering the right ventricle in one embodiment of the present invention.
  • Fig. 10 is a schematic structural diagram of the adjustable curved sheath tube of the introducer sheath in one embodiment of the present invention.
  • Figure 11 is a side view of Figure 10
  • Figure 12 is a top view of Figure 10
  • Fig. 13 is a schematic structural diagram of the adjustable curved sheath tube of the introducer sheath in one embodiment of the present invention.
  • Fig. 14 is a schematic diagram of the distal end of the adjustable sheath tube of the introducer sheath entering the left atrium through the right atrium in one embodiment of the present invention
  • Fig. 15 is a schematic diagram of the structure of the introducer sheath of the introducer sheath in one embodiment of the present invention.
  • Figure 16 is a side view of Figure 15;
  • Figure 17 is a top view of Figure 16;
  • Fig. 18 is a schematic diagram of the sheath tube structure of the bending sheath in one embodiment of the present invention.
  • Fig. 19 is a structural schematic diagram of the sheath tube distal end of the bending sheath protruding from the distal end of the introducer sheath through the aortic valve and entering the left ventricle in one embodiment of the present invention
  • Figure 20 is a sectional view of the N-N plane in Figure 19;
  • Fig. 21 is a schematic diagram of the direction adjustment of the distal end of the guide sheath of the introducer sheath and the distal end of the sheath of the bend-adjusting sheath in the aortic vessel in one embodiment of the present invention
  • Fig. 22 is a schematic diagram of the sheath tube of the adjustable sheath entering the left ventricle in one embodiment of the present invention
  • Fig. 23 is a schematic diagram of the adjustment direction of the distal end of the sheath of the bending sheath in one embodiment of the present invention.
  • Fig. 24 is a schematic diagram of an ablation needle puncturing the endocardium through the guiding sheath and the bending sheath to ablate myocardial tissue in one embodiment of the present invention
  • Figure 25 is a sectional view of the H-H plane in Figure 24;
  • Fig. 26 is a schematic diagram of the distal end of the sheath tube entering the right ventricle in one embodiment of the present invention.
  • Fig. 27 is a schematic diagram of the adjustment direction of the distal end of the guiding sheath of the introducing sheath and the distal end of the sheath of the bending adjustment sheath in one embodiment of the present invention
  • Fig. 28 is a schematic diagram of an ablation needle guided by an introducer sheath and a bending sheath to puncture the endocardium to ablate myocardial tissue in one embodiment of the present invention
  • Fig. 29 is a schematic diagram of the sheath tube distal end of the bending sheath passing through the mitral valve and entering the left ventricle in one embodiment of the present invention
  • Fig. 30 is a schematic diagram of the direction of adjustment of the distal end of the guiding sheath of the introducing sheath and the distal end of the sheath of the bending adjustment sheath in one embodiment of the present invention
  • Fig. 31 is a schematic diagram of an ablation needle puncturing the endocardium through the guiding sheath and the bending sheath to ablate myocardial tissue in one embodiment of the present invention
  • Fig. 32 is a schematic structural view of the ablation needle in one embodiment of the present invention.
  • Fig. 33 is a schematic diagram of another viewing angle of Fig. 32;
  • Figure 34 is a sectional view of the A-A plane in Figure 33;
  • Figure 35 is a sectional view of the B-B plane in Figure 33;
  • Fig. 36 is a sectional view of another embodiment of the B-B side in Fig. 33;
  • Fig. 37 is a schematic diagram of a state in which the effective length of the ablation section of the ablation needle is short in one embodiment of the present invention.
  • Fig. 38 is a schematic cross-sectional view of an ablation needle with a longer effective length of the ablation section in one embodiment of the present invention.
  • Fig. 39 is a schematic structural view of the ablation system in one embodiment of the present invention.
  • proximal end the end close to the operator
  • distal end the end far away from the operator
  • the present invention discloses an adjustable introducer sheath 11, including a guide sheath and an adjustment member (not marked in the figure), wherein the guide sheath is The prefabricated shape of the tube has certain rigidity and flexibility.
  • the adjustment member adjusts the shape of the guide sheath by applying force to the guide sheath. After the force of the adjustment member is eliminated, the guide sheath can gradually return to its natural position. state, the introducer sheath has a hollow lumen.
  • the guiding sheath includes a first tube section 111 , a second tube section 112 and a third tube section 113 which are sequentially communicated from the proximal end to the distal end.
  • the first pipe section 111, the second pipe section 112 and the third pipe section 113 are all located on the same plane, and the second pipe section 112 first extends away from the first pipe section, and then moves closer to The direction of the first pipe section 111 extends, and the third pipe section 113 extends towards the direction close to the first pipe section 111, so that the first pipe section 111 matches the shape of the descending aorta 41 of the human body, and the second pipe section 112 matches the shape of the aortic arch 42 of the human body.
  • the shape of the third pipe section 113 is adapted to the shape of the ascending aorta 43 of the human body, and the distal end of the third pipe section 113 is close to the middle part of the aortic valve 5 of the human body. Therefore, the guiding sheath in this embodiment has a predetermined shape in a natural state, which matches the shape of the human aorta, and is convenient for entering the left ventricle to treat myocardial tissue.
  • the guiding sheath 11 is in a natural state.
  • the adjustment member is connected with the guide sheath, and it is used to adjust the shape of the guide sheath.
  • the guide sheath can be adjusted in a straight state (as shown in FIG. 1C ) and a natural state (as shown in FIG. 1A ). shown) to switch between.
  • the above-mentioned straightening state refers to the state in which the shape of the above-mentioned adjustable curved sheath tube is approximately straight through the above-mentioned adjusting member, specifically, by operating the adjusting member to apply an external force opposite to the direction C to the adjustable curved sheath tube to make the adjustable curved sheath tube
  • the shape of is transformed from a curved shape in a natural state (as shown in FIG. 1A ) to an approximately straight shape (ie straightened state, as shown in FIG. 1C ) through a transition state (as shown in FIG. 1B ).
  • the adjusting member can also allow the distal end of the guiding sheath to be bent, and at this time the guiding sheath is in a bent state (as shown in FIG. 1D ).
  • the distal end of the third tube section 113 of the guiding sheath is provided with an anchoring ring, and the anchoring ring is connected to the distal end of the pulling wire built in the guiding sheath, and the proximal end of the pulling wire is connected to the regulating wire.
  • Component connections. Therefore, the above-mentioned adjusting member can adjust the bending degree of the above-mentioned third pipe section 113 by pushing and pulling the above-mentioned pulling wire, and then continue to adjust when the above-mentioned third pipe section 113 is bent away from the above-mentioned first pipe section 111 to a certain degree, which can affect the above-mentioned first pipe section 111 at this time.
  • the second pipe section 112 and the above-mentioned second pipe section 112 are gradually straightened, and finally the above-mentioned first pipe section 111, the above-mentioned second pipe section 112, and the above-mentioned third pipe section 113 are adjusted to a straight line or an approximately straight line state, so by operating the above-mentioned adjusting member
  • the above-mentioned guiding sheath can be made to enter a straightening state. Since the guiding sheath 11 is straightened by operating the adjusting member, the third section 113 of the guiding sheath 11 in the straightening state will have a partial bend during the operation, but this part does not affect the guide sheath 11.
  • the introduction sheath tube 11 enters the relevant blood vessel path as a whole. With the deepening of the guiding sheath, the external force applied to the adjustment member is gradually reduced, so that the self-alignment state gradually changes to the natural state, and finally returns to the natural state.
  • the operator can also insert a dilator into the above-mentioned guiding sheath, and straighten the above-mentioned guiding sheath through the dilator, so that the above-mentioned first tube section 111, the above-mentioned second tube section 112,
  • the above-mentioned third pipe section 113 is adjusted to a straight or nearly straight state, and then gradually withdraws the dilator along with the depth of the guiding sheath so that the self-aligning state gradually changes to a natural state, and finally returns to the natural state, and then
  • the distal end of the guiding sheath can also be adjusted by operating the adjusting member, and the guiding sheath is in a bending state at this time.
  • a guide wire can also be inserted into the dilator, and then withdrawn along with the dilator during the process of withdrawing the dilator.
  • the guide sheath in the natural state fits the shape of the aorta, wherein the shape of the first tube section 111 is similar to or the same as that of the descending aorta 41, and the shape of the second tube section 112 is similar to or equal to that of the aortic arch 42.
  • the shape of the third pipe section 113 is similar to that of the ascending aorta 43, so that when the guide sheath is inserted into the aorta and restored to its natural state, the distal portion of the third pipe section 113 will be close to the aortic valve 5
  • the orientation of the opening at the distal end of the third tube section 113 can be adjusted by operating the adjustment member. state.
  • the operator needs to apply external force to the above-mentioned first tube section 111, second tube section 112 and third tube section 113 through the adjustment member to adjust the guiding sheath to a straight line Or approximately straight line, in the process of the guiding sheath passing through the descending aorta 41, the aortic arch 42 and reaching the ascending aorta 43, the external force exerted by the adjustment member is gradually reduced, so that the above-mentioned first tube section 111, second tube section 112 and third tube section 112
  • the tube section 113 gradually returns to the natural state, so that the interference between the guide sheath and the blood vessel wall of the aorta is reduced, and the damage to the blood vessel wall caused by the friction of the guide sheath is reduced; and, when the guide sheath reaches the target position, there is no need to
  • the shape of the introducer sheath can be maintained by applying external force to the introducer sheath
  • the operator can also insert a dilator into the above-mentioned guiding sheath, and straighten the above-mentioned guiding sheath through the dilator, so that the above-mentioned first tube section 111, the above-mentioned second tube section 112, the above-mentioned
  • the third tube section 113 is adjusted to a straight or nearly straight state, and then the dilator is gradually withdrawn as the guiding sheath goes deeper, so that the self-aligning state gradually changes to a natural state, and finally returns to the natural state.
  • the shape of the guiding sheath can be maintained without applying external force to the guiding sheath, and then the distal end of the guiding sheath can be adjusted by operating the adjusting member.
  • the introducing sheath is in the state of bending.
  • the third tube section 113, the second tube section 112, and the first tube section 111 of the guiding sheath are located on the same spatial plane, and the second tube section 112 first extends away from the first tube section 111 and then toward the first tube section 111.
  • the pipe section 111 extends in the direction
  • the third pipe section 113 extends in the direction of the first pipe section 111 , that is, the third pipe section 113 extends in the direction C (pointing to the direction of the first pipe section 111 ).
  • Straightening is performed by controlling the adjusting member of the guiding sheath, so that the guiding sheath is in a straightening state, that is, applying an external force to the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath 11 to adjust it to A straight line or an approximate straight line.
  • the operator can also insert a dilator into the above-mentioned guiding sheath, and straighten the above-mentioned guiding sheath through the dilator, so that the above-mentioned first tube section 111, the above-mentioned second tube section 112, the above-mentioned
  • the third pipe section 113 is adjusted to be a straight line or an approximate straight line.
  • the guide sheath is a straight line or an approximate straight line in its natural state, and the operator applies external force through the handle to adjust the bending degree of the distal end of the guide sheath, and the guide sheath becomes the target shape Afterwards, the state of the handle needs to be maintained; and in this embodiment, the guiding sheath is in a predetermined shape in a natural state, that is, the above-mentioned third tube section 113, the second tube section 112 and the first tube section 111 are located in the same space plane, and the above-mentioned
  • the second pipe section 112 first extends away from the first pipe section 111 and then extends toward the first pipe section 111, and the third pipe section 113 extends toward the first pipe section 111 before the guiding sheath enters the aorta , the operator applies external force through the adjustment member or inserts a dilator into the guide sheath to adjust the guide sheath to a straight line or an approximate straight line.
  • the distal end of the third tube section 113 reaches the ascending aorta 43 and its opening points to the direction of the aortic valve 5 approaching the mitral valve, and the second tube section 112 is located at the aortic arch 42
  • the first tube section 111 is located in the descending aorta 41, and the operator does not need to apply any external force to the adjustment member, thereby improving the operation efficiency, preventing the operator from pulling the adjustment member for a long time, and reducing the possibility of misoperation.
  • the orientation of the distal opening of the third tube section 113 can be adjusted by operating the adjustment member, and the guide sheath is in a bending state.
  • the shape of the third tube section 113 in the natural state can ensure that the distal end of the third tube section 113 can move in two directions of being close to the interventricular septum 63 or away from the interventricular septum 63, thereby facilitating the subsequent selection of different puncture sites for dressing
  • a medical device within the introducer sheath, such as the adjustable curved sheath 12, provides different treatment positions.
  • the adjustment member includes a handle assembly and a traction piece, wherein the handle assembly includes an inner core, a shell sleeved on the inner core, a bending adjustment component rotatably sleeved on the inner core, a fixed seat and a driving piece arranged at the proximal end of the inner core , wherein the proximal end of the first pipe section 111 is fixedly connected to the inner core, the driving member is fixedly connected to the inner core, and the driving member is rotatably connected to the fixing seat, the pulling member includes a pulling wire and an anchoring ring arranged at the distal end of the pulling wire, wherein the anchoring The ring is fixed to the adjustable bending part in the first pipe section 111, the second pipe section 112 and the third pipe section 113, and the proximal end of the pulling wire is connected to the bending adjustment part, so that the pulling wire pulls the guide sheath by operating the bending adjustment part. Straight, reduce the traction applied to the guiding sheath in
  • the bending adjusting part includes a sliding part and a bending adjusting part sleeved on the sliding part.
  • the proximal end of the pulling wire is fixedly connected to the sliding part.
  • the bending parts are screwed together, and the sliding part is driven to move along the axial direction of the inner core by rotating the bending adjustment part, so as to drive the pulling wire to pull the guiding sheath to bend or restore the guiding sheath to straightness.
  • the specific adjustment process of the adjusting member to the guiding sheath can refer to the Chinese patents with the announcement numbers of CN214286246U, CN113117218A, CN216169308U and CN113181504A, which are not repeated here.
  • the rotation of the guiding sheath in the circumferential direction can be controlled by the adjusting member to control the swing of the third tube segment 113 to control the direction of the opening at the distal end of the third tube segment 113; specifically, when adjusting When the member controls the guiding sheath to rotate clockwise, the third pipe segment 113 will swing to the anterior abdomen side of the aortic arch 42 (that is, the side of the aortic arch 42 close to the chest cavity). It can be known that when the controlling guiding sheath When turning counterclockwise, the third tube section 113 will swing to the side of the aortic arch 42 near the back (ie, the side of the aortic arch 42 near the back).
  • the first pipe segment 111 in a natural state, is a straight line.
  • the proximal end of the first pipe segment 111 is straight, and the distal end is curved.
  • the curved part of the third pipe segment 113 may adopt a regular or irregular curve, preferably a circular arc.
  • the second pipe segment 112 in a natural state, is a curve, and its middle part is arched relative to the two ends.
  • the second pipe section 112 can adopt a regular or irregular curve, and the second pipe section 112 is preferably a circular arc, so that the connection transition between the first pipe section 111 and the third pipe section 113 is smooth.
  • the third tube segment 113 in a natural state, is a curve, and the curvature of the proximal part of the third tube segment 113 is smaller than the curvature of the distal part of the third tube segment 113, that is to say, the degree of curvature of the distal part of the third tube segment 113 larger than the proximal portion.
  • the distal end portion of the second pipe segment 112 and the third pipe segment 113 extend toward the first pipe segment, the distal end portion of the third pipe segment 113 will move closer to the first pipe segment 111 .
  • the distal end of the third pipe section 113 is located near the middle part of the aortic valve and close to the side of the descending aorta 41, that is, the third pipe section 113
  • the distal end of the third pipe section 113 is far away from the interventricular septum, thereby increasing the distance from the distal end of the third tube section 113 to the interventricular septum 63, thereby increasing the selection range of the introducer sheath and the adjustable curved sheath.
  • the curvatures of the first pipe section 111, the second pipe section 112 and the third pipe section 113 are different, and the curvature of the second pipe section 112 is greater than the curvature of the first pipe section 111 and the third pipe section 113, and the curvature of the third pipe section 113 The curvature is greater than that of the first pipe section 111 .
  • the curvature of the second tube section 112 may remain unchanged, or may be set such that: from the proximal end to the distal end, the curvature of the second tube section 112 first increases and then decreases, or gradually increases.
  • the second tube section 112 When the curvature of the second tube section 112 remains unchanged, the second tube section 112 basically does not interfere with the aortic arch 42 , and the damage to the vessel wall is minimal.
  • the second tube segment 112 When the curvature of the second tube segment 112 first increases and then decreases, the second tube segment 112 partially interferes with the aortic arch 42 and the area of conflict is small, and the force provided by the vessel wall to the second tube segment 112 can assist the guiding sheath to maintain its position .
  • the second tube segment 112 When the curvature of the third tube segment 112 gradually increases, the second tube segment 112 partially conflicts with the aortic arch 42 and the conflict area is large, which can increase the force used for positioning the second tube segment 112 .
  • the first tube section 111 and the second tube section 112 of the adjustable bend sheath are located on the first plane 91
  • the third tube section 113 is located on the second plane 92 having an included angle with the first plane 91 .
  • the third tube section 113 of the guide sheath, the second tube section 112 and the first pipe section 111 are also correspondingly arranged in a three-dimensional space structure, wherein the second pipe section 112 and the first pipe section 111 are located in the same plane M, and the third pipe section 113 is located in a plane L forming a certain angle with the plane .
  • the bending direction C of the third pipe segment 113 should be adjusted toward the direction of the aortic arch 42 close to the chest side of the human body, that is, the ventral direction.
  • the guide sheath can be more suitable The shape of the aortic arch.
  • the included angle between the first plane 91 and the second plane 92 is a, where 10° ⁇ a ⁇ 45°.
  • a is preferably 15°, 20°, 25°, 30°, 35° or 40°.
  • FIG. 8-9, 26-28 some embodiments disclose another adjustable introducer sheath 11:
  • the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath 11 are all located on the same plane, and the second tube section 112 first extends away from the first tube section 111 and then toward the first tube section 111
  • the third pipe section 113 extends in a direction away from the first pipe section 111 .
  • the guide sheath 11 in a natural state conforms to the shape from the inferior vena cava 71 through the right atrium 81 to the right ventricle 62, wherein the shape of the first tube section 111 is similar to or the same as that of the inferior vena cava 71,
  • the shape of the second tube section 112 is similar to or identical to the connecting channel from the inferior vena cava 71 to the right ventricle 62
  • the third tube section 113 is located in the right ventricle 62 , wherein the distal end of the third tube section 113 is close to the interventricular septum 63 .
  • the operator Before introducing the guide sheath 11 into the inferior vena cava 71, the operator applies an external force to the first pipe section 111, the second pipe section 112, and the third pipe section 113 of the guide sheath 11 through the adjustment member to adjust the guide sheath 11. It is a straight line or an approximate straight line.
  • the external force exerted by the adjustment member on the guide sheath 11 is gradually reduced, so that the first step of the guide sheath 11
  • the first tube section 111, the second tube section 112 and the third tube section 113 gradually return to the natural state, so that the interference between the guiding sheath tube 11 and the tissue wall of the right atrium 81 is reduced, and the damage to the tissue wall caused by the friction of the guiding sheath tube 11 is reduced ;
  • the guiding sheath 11 since the guiding sheath 11 has the characteristic of self-recovery deformation, when the guiding sheath 11 reaches the target position, it can maintain its natural shape without applying external force to the guiding sheath 11 .
  • the third pipe section 113, the second pipe section 112, and the first pipe section 111 of the guiding sheath are located on the same spatial plane, and the second pipe section 112 first extends away from the first pipe section 111 and then faces the first pipe section 111. Extending, the third pipe section 113 extends away from the first pipe section 111 .
  • the third pipe section 113 may extend toward the direction J.
  • the guide sheath 11 is straightened by the adjustment member, so that the guide sheath 11 is in a straightened state, that is, an external force is applied to the first pipe section 111, the second pipe section 112 and the third pipe section 113 to adjust them to a straight line or Approximate to a straight line.
  • the guide sheath is a straight line or an approximate straight line in its natural state, and the operator applies external force through the handle to adjust the bending degree of the distal end of the guide sheath, and the guide sheath becomes the target shape After that, keep the handle.
  • the guiding sheath is in a predetermined shape in a natural state, that is, the third tube section 113, the second tube section 112 and the first tube section 111 are located on the same space plane, and the second tube section 112 first moves away from the first tube section 111. After extending in the direction of the first pipe section 111, the third pipe section 113 extends away from the first pipe section 111.
  • the guiding sheath tube 11 is a straight line or an approximate straight line.
  • the external force of the adjustment member is gradually reduced, so that the first step of the guiding sheath tube 11
  • the pipe section 111, the second pipe section 112 and the third pipe section 113 gradually return to the natural state.
  • the distal end of the third pipe section 113 is located in the right ventricle 62 and its opening points to the direction of the interventricular septum 63.
  • the second pipe section 112 spans the lower The vena cava 71, the right atrium 81, and the right ventricle 62.
  • the first tube section 111 is located in the inferior vena cava 71.
  • the operator does not need to apply any external force to the handle.
  • the shape of the third tube section 113 in the natural state can ensure the third tube section 113 The distal end moves in two directions: approaching the interventricular septum 63 or away from the interventricular septum 63 , thereby facilitating the selection of different treatment sites for the adjustable curved sheath 12 subsequently passed through the guide sheath 11 .
  • the curvature of the proximal portion of the third tube segment 113 is greater than the curvature of the distal portion of the third tube segment 113 .
  • the proximal part of the third pipe section 113 is bent quickly, and then the distal end of the third pipe section 113 faces the expected direction (that is, the direction toward the interventricular septum 63), which is the guide sheath 11 and the guide sheath that passes through the guide sheath.
  • the adjustable curved sheath 12 in the 11 leaves a larger operating space, which is convenient for subsequent position selection.
  • the curvatures of the first pipe section 111, the second pipe section 112 and the third pipe section 113 are different, and the curvature of the second pipe section 112 is greater than the curvature of the first pipe section 111 and the third pipe section 113, and the curvature of the third pipe section 113 The curvature is greater than that of the first pipe section 111 .
  • the curvature of the second tube section 112 may remain unchanged, or may be set such that: from the proximal end to the distal end, the curvature of the second tube section 112 first increases and then decreases, or gradually increases.
  • the second tube section 112 When the curvature of the second tube section 112 remains unchanged, the second tube section 112 basically does not interfere with the right atrium 81 , and the damage to the tissue wall of the right atrium 81 is minimal.
  • the shape of the second pipe section 112 is similar to a J shape, and the area of partial interference between the second pipe section 112 and the right atrium 81 is small, and the tissue wall of the right atrium 81 faces the second pipe section 112 Provides force to help maintain the introducer sheath in place.
  • the area of partial conflict between the second tube section 112 and the right atrium 81 is larger, and the force provided by the tissue wall of the right atrium 81 to the second tube section 112 can further assist the introducer sheath The tube remains in place.
  • FIG. 10-12 and Figs. 26-28 another adjustable introducer sheath 11 is disclosed in some embodiments.
  • the difference between this embodiment and the above-mentioned embodiment of transcaval vein to right ventricle is only in that: In a natural state, the first tube section 111 and the second tube section 112 of the guiding sheath are located on the first plane 91 , and the third tube section 113 is located on the second plane 92 having an included angle with the first plane 91 .
  • the guide sheath in the natural state is further fitted to pass from the inferior vena cava 71 to the right atrium 81 compared with the above-mentioned embodiment.
  • the shape of the right ventricle 62 is reached, wherein the shape of the first tube segment 111 is similar to or the same as that of the inferior vena cava 71, the shape of the second tube segment 112 is similar to or the same as the shape of the connecting channel from the inferior vena cava 71 to the right ventricle 62, and the third The tube segment 113 is located in the right ventricle 62 , wherein the distal portion of the third tube segment 113 is close to the interventricular septum 63 .
  • the included angle between the first plane 91 and the second plane 92 is a, wherein, preferably: 10° ⁇ a ⁇ 45°.
  • a is preferably 15°, 20°, 25°, 30°, 35° or 40°.
  • first pipe section 111, the second pipe section 112 and the third pipe section 113 of the guiding sheath 11 are all located on the same plane, the second pipe section 112 extends away from the first pipe section 111, and the third pipe section 113 faces the first pipe section 113.
  • a pipe section 111 extends in the direction.
  • the guiding sheath in the natural state conforms to the shape from the inferior vena cava 71 to the left atrium 82 through the right atrium 81, wherein the first pipe segment 111 is similar to or identical to the shape of the inferior vena cava 71, and the second The pipe section 112 is similar to or identical to the blood vessel shape of the path of "inferior vena cava 71-right atrium 81-atrial septum 10-left atrium 82", and the third pipe section 113 is located in the left atrium 82, wherein the distal end of the third pipe section 113 part near the middle part of the mitral valve.
  • the operator Before the guiding sheath enters the inferior vena cava 71, the operator needs to apply an external force to the first tube segment 111, the second tube segment 112, and the third tube segment 113 through the adjustment member to adjust the guiding sheath to a straight line or an approximate straight line, In the process of passing through the inferior vena cava 71, the right atrium 81 and reaching the left atrium 82, the external force exerted by the adjustment member is gradually reduced, so that the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath gradually recover To the natural state, the interference between the guiding sheath and the tissue wall of the interatrial septum 10 is reduced, and the damage to the tissue wall caused by the friction of the guiding sheath is reduced; Applying external force maintains the shape of the introducing sheath.
  • the third pipe section 113, the second pipe section 112 and the first pipe section 111 of the guiding sheath are located on the same space plane, the second pipe section 112 extends away from the first pipe section 111, and the third pipe section 113 extends away from the first pipe section 113.
  • the direction of the pipe section 111 extends.
  • the third pipe section 113 may extend towards the direction X.
  • the guide sheath is straightened by the adjustment member, so that the guide sheath 11 is in a straightened state, that is, an external force is applied to the first tube section 111, the second tube section 112 and the third tube section 113 of the guide sheath, and it is adjusted to A straight line or an approximate straight line.
  • the guide sheath 11 is a straight line or an approximate straight line in its natural state.
  • the operator applies external force through the handle to adjust the bending degree of the distal end of the guide sheath 11, and the guide sheath 11 becomes the target shape. After that, keep the handle.
  • the introducer sheath 11 is in a predetermined shape in a natural state, that is, the third tube section 113, the second tube section 112 and the first tube section 111 of the guide sheath are located in the same space plane, and the second tube section 112 is along the distance from The first tube section 111 extends in the direction, and the third tube section 113 extends away from the first tube section 111.
  • the operator Before the introducer sheath 11 enters the inferior vena cava 71, the operator needs to apply external force through the adjustment member or insert and expand the introducer sheath 11. Adjust the introducer sheath 11 to be a straight line or an approximate straight line.
  • the shape of the third tube section 113 in the natural state can ensure that the distal end of the third tube section 113 can move in two directions close to the inter-ventricular septum 63 or away from the inter-ventricular septum 63, thereby It is helpful for the subsequent selection of the introducer sheath and the adjustable curved sheath 12 for different treatment sites.
  • the first pipe segment 111 in a natural state, is a straight line.
  • the proximal end of the first pipe segment 111 is straight, and the distal end is curved.
  • the curved part of the third pipe section 113 may adopt a regular or irregular curve, preferably an arc.
  • the second pipe segment 112 in a natural state, is a curve, and its middle part is arched relative to the two ends.
  • the second pipe section 112 can adopt a regular or irregular curve, and the second pipe section 112 is preferably a circular arc, so that the connection transition between the first pipe section 111 and the third pipe section 113 is smooth.
  • the second pipe segment 112 in a natural state, is a curve, and the curvature of the proximal end of the second pipe segment 112 is greater than the curvature of the distal end of the second pipe segment 112 .
  • the second tube segment 112 is quickly bent toward the interatrial septum 10 so that the distal end of the second tube segment 112 passes through the interatrial septum 10 .
  • the third pipe section 113 in a natural state, is a curve, and the curvature of the proximal end of the third pipe section 113 is smaller than the curvature of the distal end of the third pipe section 113 .
  • the proximal part of the third tube section 113 extends along the extension direction of the distal part of the second tube section 112, and by increasing the curvature of the distal part of the third tube section 113, the distal end of the third tube section 113 faces the middle of the mitral valve part.
  • the curvatures of the first pipe section 111, the second pipe section 112 and the third pipe section 113 are different, and the curvature of the second pipe section 112 is greater than the curvature of the first pipe section 111 and the third pipe section 113, and the curvature of the third pipe section 113 The curvature is greater than that of the first pipe section 111 .
  • the curvature of the second tube section 112 may remain unchanged, or may be set such that: from the proximal end to the distal end, the curvature of the second tube section 112 first increases and then decreases, or gradually increases.
  • the second tube section 112 When the curvature of the second tube section 112 remains unchanged, the second tube section 112 basically does not interfere with the right atrium 81 , and the tissue wall of the interatrial septum 10 is minimally damaged.
  • the area of partial conflict between the second tube segment 112 and the tissue wall of the atrial septum 10 is small, and the force provided by the tissue wall of the atrial septum 10 to the second tube segment 112 can assist in guiding The sheath remains in place.
  • the area of partial conflict between the second tube segment 112 and the tissue wall of the atrial septum 10 is larger, further enhancing the force provided by the tissue wall of the atrial septum 10 to the second tube segment 112 .
  • some embodiments disclose another adjustable introducer sheath 11.
  • the difference between this embodiment and the above embodiment of passing through the inferior vena cava to the left ventricle is only that:
  • the first tube section 111 and the second tube section 112 of the guiding sheath are located on the same plane, and the third tube section 113 is located on the second plane 92 having an included angle with the first plane 91 .
  • angle a between the first plane 91 and the second plane 92, preferably: 10° ⁇ a ⁇ 45°.
  • a is preferably 15°, 20°, 25°, 30°, 35° or 40°.
  • the channel from the inferior vena cava 71 to the left atrium 82 is a three-dimensional channel
  • the guiding sheath in the natural state can be further fitted to pass from the inferior vena cava 71 to the right Atrium 81 reaches the shape of left atrium 82
  • the shape of the first pipe section 111 is similar to or the same as that of the inferior vena cava 71
  • the second pipe section 112 is similar to the shape of "inferior vena cava 71-right atrium 81-atrial septum 10-left atrium 82".
  • the shape of the blood vessels of the first path is similar or the same
  • the third tube segment 113 is located in the left atrium 82, wherein the distal part of the third tube segment 113 is close to the middle part of the mitral valve.
  • the operator Before the introducer sheath 11 enters the inferior vena cava 71, the operator needs to apply external force to the first pipe section 111, the second pipe section 112, and the third pipe section 113 through the adjustment member or insert a dilator into the introducer sheath 11 to push the guide sheath It is adjusted to a straight line or an approximate straight line.
  • an ablation device 1 including a delivery component (not marked in the figure) and an ablation component (not marked in the figure); the ablation component is movably worn in the delivery component, and the ablation component includes The ablation needle 13 ; the delivery assembly is used to intervene in the heart through a catheter. After passing through the delivery assembly, the ablation needle 13 enters the myocardial tissue by puncturing the endocardium to perform ablation on the myocardial tissue.
  • the delivery assembly includes an introducer sheath 11 and an adjustable curved sheath 12 ; the adjustable curved sheath 12 is movably threaded in the introducer sheath 11 ; and the ablation needle 13 is movably threaded in the adjustable curved sheath 12 .
  • the introducer sheath 11 is a tubular structure with a hollow lumen, and its lumen serves as a channel for the adjustable curved sheath 12 to pass through.
  • the distal end of the ablation needle 13 can extend out of the distal end of the adjustable curved sheath 12;
  • the sheath 12 is bent to drive the ablation needle 13 to point to and insert into different positions of the interventricular septum 63 .
  • the introducer sheath 11 has a shape matching the intervening heart interventricular septum 63 channel in a natural state or after being bent.
  • the introducer sheath 11 is any one of the adjustable introducer sheaths 11 in the above-mentioned embodiments.
  • the adjustable curved sheath 12 is disposed in the hollow lumen of the introducer sheath 11 and can move relative to the introducer sheath 11 along the direction of the central axis.
  • the adjustable curved sheath 12 has at least a main body section 121, a shaping section 121 and a bending section 123 from the proximal end to the distal end, the shape of the main body section 121 is adapted to the shape of the first tube section 111 of the adjustable introducer sheath 11,
  • the shape of the shaping section 121 is adapted to the shape of the second pipe section 112 and the third pipe section 113 of the adjustable introducer sheath 11, so that the adjustable curved sheath 12 and the adjustable introducer sheath 11 are more structurally correct. Good fit.
  • the structure of the adjustable curved sheath 12 is illustrated below.
  • the adjustable curved The structure of the sheath 12 is adaptively adjusted with reference to this embodiment.
  • the distal portion of the shaping section 121 extends away from the direction of the interventricular septum 63
  • the bending section 123 extends toward the direction of the interventricular septum 63 .
  • the adjustable bend sheath 12 is delivered through the lumen of the adjustable introducer sheath 11, and the bend-adjusting section 123 will move from the adjustable
  • the position of the distal opening of the third tube section 113 of the adjusted introducer sheath 11 stretches out, and crosses the aortic valve 5 to reach the position of the LVOT (left ventricular outflow tract 64).
  • the adjustable curved sheath 12 is in a natural state (unadjusted bend).
  • the adjustable bending sheath 12 is connected with a bending handle, and by controlling the rotation of the bending adjusting handle of the adjustable bending sheath 12, the circumferential swing of the bending section 123 of the adjustable bending sheath 12 can be controlled. Specifically, when the bending adjustment handle is rotated in the clockwise direction, the bending adjustment section 123 will exhibit a slight swing in the counterclockwise direction, and swing at an angle toward the back of the aortic arch 42 (dorsal direction);
  • the bending adjustment section 123 When controlling the rotation of the bending adjustment handle in the counterclockwise direction, the bending adjustment section 123 will exhibit a slight clockwise swing and an angled swing toward the aortic arch 42 toward the chest (ventral direction).
  • the bending direction D of the bending section 123 can be directed toward the outside of the aortic arch 42, that is, toward the interventricular septum 63.
  • the bending section 123 can be adjusted to the outside of the aortic arch 42. Or release the bending adjustment, so as to ensure that the distal end of the bending adjustment section 123 is always facing the side of the interventricular septum 63, so that the ablation needle 13 has a correct needle exit angle and direction when puncturing.
  • the distal end of the bending section 123 will contact the left ventricle side wall of the interventricular septum 63, thereby preparing for subsequent needle withdrawal.
  • the distal part of the shaping section 121 extends away from the direction of the interventricular septum 63, and the bending adjustment section 123 extends towards the direction of the interventricular septum 63, that is, the distal end of the adjustable bending sheath 12 is set in a manner that is far away from and then close to the interventricular septum 63 Compared with the shape of the distal part of the adjustable curved sheath 12 that is directly close to the interventricular septum 63 in the prior art, the needle exit angle of the adjustable bending section 123 can be increased by first moving away from the interventricular septum 63 and then approaching the interventricular septum 63 .
  • the ablation method of the ablation needle 13 can be selected from radiofrequency ablation, microwave ablation, alcohol ablation and the like.
  • radiofrequency ablation is selected, please refer to Figures 32 to 38, the ablation needle 13 includes a needle body 132, and an ablation segment 134 is at least partially provided on the needle body 132, and the ablation segment 134 is conductive and used to conduct radio frequency Ablation energy.
  • the ablation needle 13 is connected to the ablation energy generating device 2, which is a prior art (refer to CN204683760U, CN106264711B, US20140364850A1), and will not be repeated here.
  • the needle body 132 is provided with at least one perfusion hole 132 a, and the perfusion hole 132 a communicates with the inside of the needle body 132 .
  • the ablation needle 13 can puncture the endocardial tissue under the puncture of the needle tip 131, so that the distal end of the ablation needle 13, including the needle tip 131, the perfusion hole 132a, and the ablation section 134, enters the hypertrophic area of the interventricular septum 63, and releases energy through the ablation section 134 to destroy the
  • the cell activity of the hypertrophic myocardial tissue makes the hypertrophic myocardial tissue of the interventricular septum 63 thinner and the contraction force decreases, thereby reducing the obstruction of the left ventricular outflow tract 64; at the same time, under the perfusion of the electrolyte solution 31 in the perfusion hole 132a, the solution in the myocardium
  • the diffusion inside the tissue brings the radio frequency energy to the myocardial tissue that is farther away from the ablation section 134, thereby achieving the purpose of expanding the ablation range.
  • the needle tip 131 of the ablation needle 13 is a closed and sharp tip structure, and its shape includes but is not limited to shapes such as cones, triangular pyramids, quadrangular pyramids, single-slope cutting edges, etc.
  • the purpose of the shape of the needle tip 131 is to provide a sharp enough
  • the structure of the needle tip 131 enables it to puncture the endocardial tissue with a small puncture force, thereby smoothly entering the myocardial tissue of the interventricular septum 63 .
  • the needle tip 131 is fixed to the distal end of the needle body 132 through connection methods including but not limited to bonding, laser welding, welding and the like.
  • the needle body 132 is a hollow long tubular structure with a completely through cavity inside.
  • the ablation needle 13 can perfuse the corresponding electrolyte solution 31 through the proximal end of the needle body 132, and the electrolyte solution 31 is transported to the distal end of the ablation needle 13 through the lumen 132b of the needle body 132, and is set on the ablation segment 134 by the distal end of the ablation needle 13.
  • the perfusion hole 132a is released.
  • the ablation needle 13 is not provided with a perfusion hole 132a, but a circulation channel is provided in the ablation needle 13, and a cooling liquid circulates in the circulation channel, and the cooling liquid flows in the channel, thereby cooling the ablation needle 13 , to avoid local tissue overheating and even tissue damage caused by high temperature.
  • the cross section of the needle body 132 is preferably a cylindrical structure.
  • the needle body 132 may also have an elliptical structure.
  • the outer wall of the needle body 132 should be smooth without obvious protrusions and edges and corners, so as to prevent it from scratching tissues such as the vascular intima when it enters the target position of the human body.
  • the needle body 132 is preferably made of a metal material with good electrical conductivity, so that it can achieve the purpose of releasing radio frequency energy through the excellent electrical conductivity of the needle body 132 itself.
  • the above-mentioned ablation section 134 should be used as the needle body Part of 132.
  • the material of the needle body 132 may include, but not limited to, metal pipes such as stainless steel pipes and nickel-titanium alloys.
  • the ablation needle 13 is preferably made of a metal tube with high biocompatibility, specifically, because nickel-titanium alloy has excellent biocompatibility, and has high strength, good shape, and after heat treatment It can reflect the mechanical properties of superelasticity, so the needle body 132 made of nickel-titanium alloy can maintain good rebound performance after going through complex and tortuous blood vessel paths and repeated bending adjustments, without plastic deformation. Therefore, the system can pass through the blood vessel more smoothly to reach the target position without increasing the passing resistance due to the plastic deformation of the needle body 132 .
  • the needle body 132 may also be made of a polymer material.
  • the ablation segment 134 should be an independent component fixed on the needle body 132 with good electrical conductivity.
  • the polymer materials used should have excellent strength, hardness, high elastic modulus and good bending resistance, and can not break and plasticity under repeated bending.
  • Deformation on the other hand, in order to ensure that the needle body 132 has excellent pushing performance in the process of moving back and forth along the central axis of the adjustable curved sheath 12, the material should have a low surface friction coefficient, which can reduce the friction of the ablation needle 13. Adjust the pushing resistance inside the lumen of the curved sheath 12, and at the same time, in order to ensure the insulation of the needle body 132, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant, and high voltage resistance.
  • the needle body 132 is preferably made of polymer materials such as PP, HDPE, PTFE and the like.
  • At least one ablation section 134 is arranged at the distal end of the ablation needle 13 , and the ablation section 134 can realize electrical conduction with the ablation energy generating device 2 , so as to release energy into the tissue through the ablation section 134 .
  • the ablation section 134 should exist as a part of the needle body 132. Specifically, at this time, a layer of insulating layer 133 should be attached to the outside of the needle body 132, and the needle body 132 should be far away from the The exposed area where the end is not covered with insulating material serves as the ablation segment 134 for releasing radiofrequency energy.
  • the insulating layer 133 can be a layer of polymer material coated on the needle body 132 by heat shrinkage, or can be directly sleeved on the outside of the needle body 132 , or can be attached to the outside of the needle body 132 through a coating process.
  • the outer surface of the insulating layer 133 should have a lower coefficient of friction and a higher insulation resistance.
  • the lower coefficient of friction can endow the ablation needle 13 with good lubricity and pushability, and the higher insulation resistance can make the insulating layer 133 work at high temperature. Under the action of high-frequency radio frequency current, it still maintains excellent dielectric insulation without being broken down.
  • the insulating material When the insulating layer 133 is coated on the outside of the needle body 132 by heat shrinkage, the insulating material preferably uses materials such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), and FEP (fluorinated ethylene propylene). .
  • PET polyethylene terephthalate
  • PTFE polytetrafluoroethylene
  • FEP fluorinated ethylene propylene
  • the insulating layer 133 is preferably made of materials such as PEEK (polyether ether ketone), PI (polyimide), and the like.
  • the insulating material is preferably Parylene.
  • the insulating layer 133 can be provided only at the distal end of the needle body 132 , or can run through the entire needle body 132 of the ablation needle 13 .
  • the ablation segment 134 should be an independent component fixed on the outside of the needle body 132 with good electrical conductivity.
  • the ablation section 134 should be one or more ring-shaped metal electrodes, which are fixed on the distal end of the needle body 132 by means including but not limited to bonding, welding, crimping, welding, etc.
  • the wire is electrically connected with the external energy generating device.
  • the ring-shaped metal electrode is preferably made of radiopaque metal materials such as platinum-iridium alloy, cobalt-chromium alloy, and tantalum. In this way, while having excellent electrical conductivity, it can also have a developing effect under radiation, which helps the operator The effect of the position of the ablation segment 134 is confirmed.
  • the effective length L of the ablation section 134 refers to the length exposed outside the insulating layer 133 and capable of contacting the tissue to be treated, and the effective length L of the ablation section 134 is preferably 5mm-15mm.
  • the length of the ablation section 134 is fixed, that is, the relative position between the needle body 132 and the insulating layer 133 is fixed.
  • the effective length of the ablation section 134 in the same set of ablation needles 13 is With a certain fixed value, a variety of ablation needles 13 of different models and specifications can be designed by setting ablation segments 134 of different effective lengths, so as to meet the use requirements of different patients with different tissue shapes and sizes.
  • no perfusion hole is provided on the ablation needle 13, and a circulation channel (not shown in the figure) is provided inside the needle body, and the circulation channel is used for circulating cooling liquid to take away the heat of the ablation needle 13 , to avoid local tissue overheating and even tissue damage caused by high temperature. Further, a circulation channel is also provided in the ablation segment of the ablation needle.
  • the relative position between the needle body 132 and the insulating layer 133 can be adjusted, so as to achieve different exposed lengths of the needle body 132 and achieve the effective adjustment of different ablation segments 134. length purpose.
  • an insulating sleeve is provided outside the needle body 132, and the insulating sleeve is used as the above-mentioned insulating layer 133, and the insulating sleeve and the needle body 132 can slide relative to each other, and the effective length L of the ablation section 134 can be controlled by controlling the relative movement between the needle body 132 and the insulating layer 133.
  • the ablation needle 13 is correspondingly provided with an ablation operation handle (not shown in the figure), and a push structure is provided on the ablation operation handle, and the push structure is connected with the insulating sleeve, which can drive the insulation sleeve to slide relative to the needle body 132, thereby Adjust the length of the needle body 132 exposed outside the insulating sleeve, that is, adjust the effective length L of the ablation section 134; the ablation operation handle is also provided with a locking structure, which is connected with the needle body 132 for locking and fixing The needle body 132 restricts relative movement between the needle body 132 and the insulating sleeve.
  • the needle body 132 and the insulating sleeve remain relatively fixed, that is, the effective length of the ablation section 134 remains unchanged, the endocardial tissue can be punctured and inserted into the myocardial tissue of the interventricular septum 63,
  • the needle body 132 can be locked by the locking structure of the ablation operation handle so that it remains fixed along the central axis of the adjustable curved sheath 12, and then the ablation operation can be performed by pushing
  • the pushing structure in which the handle is fixedly connected to the insulating sleeve enables the insulating sleeve to move back and forth relative to the central axis of the needle body 132, so as to control the elongation or shortening of the ablation section 134 exposed outside the insulating sleeve. This changes the effective length of the ablation segment 134 .
  • the locking structure is connected with the insulating sleeve for locking and fixing the insulating sleeve
  • the pushing structure is connected with the needle body 132 and can drive the needle body 132 to slide relative to the insulation sleeve.
  • the endocardial tissue is pierced together and inserted into the myocardial tissue of the interventricular septum 63.
  • the effective length of the ablation section 1341 needs to be changed.
  • the insulating sleeve remains fixed along the direction of the central axis of the needle body 132, and then by pushing the pushing structure, the needle body 132 can achieve relative movement back and forth along the direction of the central axis of the insulating sleeve, thereby The purpose of controlling the elongation or shortening of the ablation section 134 exposed outside the insulating sleeve is achieved, thereby changing the effective length of the ablation section 134 .
  • the ablation needle 13 is preferably provided with at least one or more perfusion holes 132a, and the perfusion holes 132a are preferably disposed outside the ablation section 134 and evenly distributed in the axial and circumferential directions of the needle body 132 .
  • the shape of the perfusion hole 132a can be a circle, an ellipse or the like.
  • the perfusion hole 132a is preferably processed and shaped by laser cutting.
  • the function of the perfusion hole 132a is to perfuse the electrolyte solution 31 into the tissue, and the used electrolyte solution 31 is transported through the lumen 132b of the needle body 132 .
  • the range of the ablation area of the ablation needle 13 has a clear relationship with the output power, output time, tissue impedance and ablation temperature of the radiofrequency current. The temperature between them is proportional to the output power of the radiofrequency current. In theory, the size of the ablation area can be increased through higher output power and higher tissue temperature.
  • the tissue in contact with the ablation segment 134 will be scorched and scabbed, and the scorched and scabbed tissue will adhere to the surface of the ablation segment 134 to form an electrically insulating coagulum , accompanied by a sudden increase in electrical impedance, which prevents further current from flowing into the tissue and further heating, thereby greatly reducing the range of the ablation area. Therefore, in order to prevent this phenomenon, improve the ablation efficiency, and increase the range of the ablation area, the risk of tissue scarring can be reduced by reducing the temperature of the contact surface between the ablation segment 134 and the tissue.
  • the electrolyte solution 31 perfused through the perfusion hole 132a can cool the ablation segment 134 to a certain extent, reduce the temperature between the ablation segment 134 and the tissue contact interface, so that the energy generated by the ablation segment 134 can go deeper into the myocardial tissue
  • the electrolyte solution 31 will diffuse after perfusion into the myocardial tissue, the diffused electrolyte solution 31 will serve as a good transmission medium for radiofrequency current, The radio frequency current is transmitted to the farther distance of the myocardial tissue, and through this principle, the purpose of increasing the range of the ablation area can also be achieved.
  • the above electrolyte solution 31 can be used including but not limited to 0.9% NaCl solution at room temperature, 0.9% NaCl solution at 5°C, 5% glucose solution, heparinized 0.9% NaCl solution, a mixed solution of 0.9% NaCl solution and contrast agent , at the same time, we should consider that, in order to better reduce the temperature between the ablation segment 134 and the myocardial tissue contact interface during radio frequency discharge, it is preferable to use 0.9% NaCl solution at about 5°C, and cold saline can more effectively reduce temperature.
  • the electrolyte solution 31 can be a mixed solution of cold physiological saline + contrast agent, through X-ray contrast, the operator can intuitively observe the diffusion of the electrolyte solution 31 mixed with contrast agent in the myocardial tissue, so as to control the ablation process in real time Time, perfusion flow and flow rate, etc., so as to achieve the purpose of accurately controlling the size of the ablation area.
  • the structure of the ablation needle 13 using microwave ablation, alcohol ablation and other ablation methods is basically the same as that of the ablation needle 13 using radiofrequency ablation, and will not be repeated here.
  • an ablation system 100 which includes the ablation device 1 in the above embodiments; and also includes an ablation energy generating device 2, which is connected to the ablation device 1 to provide the ablation device 1 with energy.
  • the ablation device 1 includes a delivery assembly and an ablation assembly; the ablation assembly is movably worn in the delivery assembly, and the ablation assembly includes an ablation needle 13; After that, enter the myocardial tissue by puncturing the endocardium, and then the ablation energy generating device 2 provides energy for the ablation needle 13 to perform ablation on the myocardial tissue.
  • the ablation system 100 further includes a perfusion device 3 , which is used to provide liquid for the ablation device 1 , and the liquid is the above-mentioned electrolyte solution 31 .
  • the ablation needle 13 is provided with a perfusion hole, and the electrolyte solution can be used to expand the ablation range.
  • the ablation needle is not provided with a perfusion hole, but a cooling channel is provided inside the needle body, through which the electrolyte solution can cool the needle body.
  • Some embodiments disclose a method of myocardial ablation, the method comprising the following steps:
  • Ablation of myocardial tissue by this method achieves minimally invasive treatment in the true sense, without the need for thoracotomy and other traumatic treatment methods for patients; on the other hand, it can also puncture the endocardium for multi-point At the same time, it avoids the risk of piercing blood vessels or even piercing the heart when puncturing the epicardium in transapical ablation.
  • the myocardial tissue is the interventricular septum 63 .
  • path for myocardial ablation is one of path a, path b, and path c;
  • Route a reach the left ventricle 61 through the femoral artery and the aortic arch 42;
  • Route b via inferior vena cava 71 , right atrium 81 , to right ventricle 62 ;
  • Route c through the inferior vena cava 71 , the right atrium 81 , the atrial septum 10 and the left atrium 82 , to reach the left ventricle 61 .
  • Some embodiments disclose another method of myocardial ablation, the method comprising the steps of:
  • the adjustable introducer sheath 11 adopts any one of the above-mentioned embodiments.
  • the myocardial tissue is the interventricular septum 63 .
  • path for myocardial ablation is one of path a, path b, and path c;
  • Route a reach the left ventricle 61 through the femoral artery and the aortic arch 42;
  • Route b via inferior vena cava 71 , right atrium 81 , to right ventricle 62 ;
  • Route c through the inferior vena cava 71 , the right atrium 81 , the atrial septum 10 and the left atrium 82 , to reach the left ventricle 61 .
  • Path a corresponds to the use of the adjustable introducer sheath 11 through the aorta in the above embodiment
  • path b corresponds to the use of the adjustable introducer sheath 11 through the inferior vena cava, right atrium, and right ventricle in the above embodiment
  • path c corresponds to The adjustable introducer sheath 11 through the inferior vena cava, right atrium, and left atrium in the above-mentioned embodiment is used.
  • the handle 14 is defined below as an operating component for the guiding sheath, adjustable curved sheath 12 and ablation needle 13, including but not limited to bending degree, direction adjustment and pushing. Its structure is the prior art, and the specific structure You can refer to other documents of the prior art, such as publications whose publication numbers are CN214286246U and CN203447358U.
  • path a When path a is selected, straighten the guide sheath through the handle 14 and insert it into the aorta, and gradually reduce the external force applied by the handle to the guide sheath as the guide sheath goes deeper. After the third tube segment 113 reaches the target position, ie, the ascending aorta 43, the external force exerted by the handle on the introducer sheath 11 is removed, so that the guide sheath returns to its natural state.
  • the ablation needle 13 is extended from the distal opening of the adjustable curved sheath 12 and pierced into the target tissue to deliver ablation energy for ablation.
  • a developing component such as a developing ring made of metal or a smeared developing material, is placed on the third tube section 113 of the guiding sheath or applied with a developing material. (not shown in the figure) guide, and send the guide sheath through the aortic arch 42 to the position of the aortic valve 5 near the aortic arch 42, as shown in FIG. 5 .
  • the handle 14 By operating the handle 14, the bending direction and the bending angle of the adjustable guide sheath 11 and the bending section 123 of the adjustable bending sheath 12 are controlled, so that the distal end of the adjustable bending sheath 12 can be well attached to the The interventricular septum 63 is at the expected puncture ablation point.
  • the perfusion device 3 After completing the above steps, first start the perfusion device 3, set the perfusion flow rate, so that the electrolyte solution 31 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuse it outside the tissue for a period of time, then turn on the ablation energy generating device, through
  • the ablation section 134 of the ablation needle 13 performs ablation on the hypertrophic myocardial tissue, and the size of the ablation range is judged by ultrasound and/or radiography, and the length of the ablation section 134 can be adjusted by controlling the handle according to the actual size of the ablation area to achieve The purpose of controlling the ablation zone.
  • multiple continuous ablation zones will be left on the hypertrophic interventricular septum 63.
  • multiple ablation zones can be connected together to form a long continuous ablation range, and all puncture points are punctured
  • withdraw the ablation needle 13, the adjustable curved sheath 12, and the guide sheath 11 in sequence and complete the blood vessel suture and the skin suture at the puncture point.
  • route b If route b is selected, then: under the guidance of ultrasound/CT, puncture through the femoral vein, guided by a guide wire (not shown), pass the adjustable introducer sheath 11 through the inferior vena cava 71, the right atrium 81 and enter the right The position of the ventricle 62 is shown in FIG. 9 .
  • the handle 14 By operating the handle 14, the bending direction (direction J, direction K) and the size of the bending angle of the adjustable guide sheath 11 and the bending section 123 of the adjustable bending sheath 12 are controlled, so that the distance of the adjustable bending sheath 12 is The end can be well attached to the expected puncture and ablation point on the interventricular septum 63 .
  • the perfusion device 3 After completing the above steps, first start the perfusion device 3, set the perfusion flow rate, so that the electrolyte solution 31 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuse it outside the tissue for a period of time, then turn on the ablation energy generating device, through The ablation section 134 of the ablation needle 13 performs ablation on hypertrophic myocardial tissue.
  • the size of the ablation range is judged by ultrasound and/or contrast, and the length of the ablation section 134 can be adjusted through the control handle 14 according to the actual size of the ablation area, so as to achieve the purpose of controlling the ablation area.
  • the energy output of the energy generating device is stopped, the perfusion of the electrolyte solution 31 is stopped, and the ablation needle 13 is returned to the adjustable curved sheath 12 .
  • the bending section 123 of the adjustable bending sheath 12 so that its distal end is out of contact with the interventricular septum 63, and then operate the adjustable bending sheath 12 to select the next point.
  • the distal end of the adjustable bending sheath 12 will appear An arc swing from point E to point F (as shown in Figure 23), within a suitable range, select 1, 2, 3, 4 or even more puncture sites.
  • multiple continuous ablation zones will be left on the hypertrophic interventricular septum 63 .
  • the multiple ablation zones can be connected together to form a strip-shaped continuous ablation range.
  • the ablation needle 13, the adjustable curved sheath 12, and the guide sheath 11 are sequentially withdrawn, and blood vessel suture and skin suture at the puncture point are completed.
  • path c If path c is selected, then: Under the guidance of ultrasound/CT, transfemoral vein puncture, guided by a guide wire (not shown), the adjustable introducer sheath 11 passes through the inferior vena cava 71, the right atrium 81 and through the interatrial septum 10 into the position of the left atrium 82, as shown in FIG. 14 .
  • the handle 14 By operating the handle 14, the bending direction (direction X, direction Y) and the size of the bending angle of the adjustable guide sheath 11 and the bending section 123 of the adjustable bending sheath 12 are controlled, so that the distance of the adjustable bending sheath 12 The end can be well attached to the expected puncture and ablation point on the interventricular septum 63 .
  • the perfusion device 3 After completing the above steps, first start the perfusion device 3, set the perfusion flow rate, so that the electrolyte solution 31 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuse it outside the tissue for a period of time, then turn on the ablation energy generating device, through The ablation segment 134 at the distal end of the ablation needle 13 performs ablation of hypertrophic myocardial tissue.
  • the size of the ablation range is judged by ultrasound and/or contrast, and the length of the ablation section 134 can be adjusted through the control handle 14 according to the actual size of the ablation area, so as to achieve the purpose of controlling the ablation area.
  • the energy output of the energy generating device is stopped, the perfusion of the electrolyte solution 31 is stopped, and the ablation needle 13 is returned to the adjustable curved sheath 12 .
  • multiple continuous ablation zones will be left on the hypertrophic interventricular septum 63 .
  • the multiple ablation zones can be connected together to form a strip-shaped continuous ablation range.
  • the ablation needle 13, the adjustable curved sheath 12, and the guide sheath 11 are sequentially withdrawn, and blood vessel suture and skin suture at the puncture point are completed.
  • Some embodiments disclose another method of myocardial ablation, the method comprising the following steps:
  • the adjustable introducer sheath 11 adopts any adjustable introducer sheath 11 in any of the above-mentioned embodiments.
  • step S1 before inserting the adjustable introducing sheath 11 into the path, the adjustable introducing sheath 11 is straightened first.
  • the myocardial tissue is the interventricular septum 63 .
  • path for myocardial ablation is one of path a, path b, and path c;
  • Route a reach the left ventricle 61 through the femoral artery and the aortic arch 42;
  • Route b via inferior vena cava 71 , right atrium 81 , to right ventricle 62 ;
  • Route c through the inferior vena cava 71 , the right atrium 81 , the atrial septum 10 and the left atrium 82 , to reach the left ventricle 61 .
  • Path a corresponds to the use of the adjustable introducer sheath 11 through the aorta in the above embodiment
  • path b corresponds to the use of the adjustable introducer sheath 11 through the inferior vena cava, right atrium, and right ventricle in the above embodiment
  • path c corresponds to The adjustable introducer sheath 11 through the inferior vena cava, right atrium, and left atrium in the above-mentioned embodiment is used.
  • the adjustable introducer sheath 11 provided by the present invention is pre-shaped so that the introducer sheath can match the path of entering the heart in a natural state. After the adjustable introducer sheath 11 enters the body and It is in a natural state after reaching the target position, and maintains the shape of the introducer sheath 11 without applying external force;
  • the second tube section 112 by setting different curvatures of the second tube section 112 , it is possible to reduce tissue wall or blood vessel wall damage and provide positioning support for the introducer sheath 11 .
  • the electrolyte solution 31 can cool down the temperature of the contact interface between the ablation section 134 and the tissue through perfusion ablation, which reduces the probability of tissue scarring and enables the temperature to be transmitted deeper into the tissue. Thereby expanding the scope of ablation.
  • the electrolyte solution 31 can be used as an energy transfer medium, and through its diffusion inside the tissue, the energy can be transferred to a deeper tissue, thereby expanding the range of ablation.
  • the ablation section 134 of the ablation needle 13 is set to be adjustable.

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Abstract

Une gaine de guidage réglable (11), un appareil d'ablation (1), un système d'ablation (100) et un procédé d'ablation myocardique, qui se rapportent au domaine technique des dispositifs médicaux. La gaine de guidage réglable (11) comprend un tube de gaine préformé, de telle sorte que la gaine de guidage (11), lorsqu'elle se trouve dans un état naturel, présente une forme correspondant à une voie cardiaque d'intervention correspondante. Avant que la gaine de guidage (11) n'intervienne dans un corps humain, une force externe est appliquée au tube de gaine de la gaine de guidage (11) pour le redresser, et une fois que le tube de gaine entre dans le corps et atteint une position cible, la force externe est retirée, de telle sorte que le tube de gaine se trouve dans un état naturel, et ainsi, aucune force externe n'a besoin d'être appliquée pour maintenir la forme de la gaine de guidage (11).
PCT/CN2022/116388 2021-12-31 2022-08-31 Gaine de guidage réglable, appareil d'ablation, système d'ablation et procédé d'ablation myocardique Ceased WO2023124180A1 (fr)

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PCT/CN2022/116388 Ceased WO2023124180A1 (fr) 2021-12-31 2022-08-31 Gaine de guidage réglable, appareil d'ablation, système d'ablation et procédé d'ablation myocardique

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117100197A (zh) * 2023-10-23 2023-11-24 杭州堃博生物科技有限公司 鞘管调弯方法、装置、非易失性存储介质及电子设备
CN119587141A (zh) * 2024-12-05 2025-03-11 首都医科大学附属北京安贞医院 肥厚梗阻性心肌病消融装置和消融方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020026198A1 (en) * 1995-02-14 2002-02-28 Daig Corporation Guiding introducers for use in the treatment of accessory pathways around the mitral valve using a retrograde approach
US20040215139A1 (en) * 2002-12-20 2004-10-28 Todd Cohen Apparatus and method for implanting left ventricular pacing leads within the coronary sinus
CN2782017Y (zh) * 2005-03-08 2006-05-24 深圳市惠泰医疗器械有限公司 电生理电极导管
WO2006091597A1 (fr) * 2005-02-22 2006-08-31 Cardiofocus, Inc. Catheter a gaines orientable
CN111374814A (zh) * 2018-12-28 2020-07-07 杭州唯强医疗科技有限公司 可调弯鞘管及支架输送装置
US20200367871A1 (en) * 2019-05-22 2020-11-26 Evalve, Inc. Devices and systems for accessing and repairing a heart valve
CN111991674A (zh) * 2020-09-26 2020-11-27 龙德勇 一种肥厚梗阻性心肌病消融装置及方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6066126A (en) * 1997-12-18 2000-05-23 Medtronic, Inc. Precurved, dual curve cardiac introducer sheath
US20070016130A1 (en) * 2005-05-06 2007-01-18 Leeflang Stephen A Complex Shaped Steerable Catheters and Methods for Making and Using Them
US20120158021A1 (en) * 2010-12-19 2012-06-21 Mitralign, Inc. Steerable guide catheter having preformed curved shape
US12350454B2 (en) * 2018-10-04 2025-07-08 The University Of Chicago LIMA crossover integrated catheter system
AU2020324390B2 (en) * 2019-08-02 2025-12-04 Vizaramed, Inc. Steerable sheath

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020026198A1 (en) * 1995-02-14 2002-02-28 Daig Corporation Guiding introducers for use in the treatment of accessory pathways around the mitral valve using a retrograde approach
US20040215139A1 (en) * 2002-12-20 2004-10-28 Todd Cohen Apparatus and method for implanting left ventricular pacing leads within the coronary sinus
WO2006091597A1 (fr) * 2005-02-22 2006-08-31 Cardiofocus, Inc. Catheter a gaines orientable
CN2782017Y (zh) * 2005-03-08 2006-05-24 深圳市惠泰医疗器械有限公司 电生理电极导管
CN111374814A (zh) * 2018-12-28 2020-07-07 杭州唯强医疗科技有限公司 可调弯鞘管及支架输送装置
US20200367871A1 (en) * 2019-05-22 2020-11-26 Evalve, Inc. Devices and systems for accessing and repairing a heart valve
CN111991674A (zh) * 2020-09-26 2020-11-27 龙德勇 一种肥厚梗阻性心肌病消融装置及方法

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117100197A (zh) * 2023-10-23 2023-11-24 杭州堃博生物科技有限公司 鞘管调弯方法、装置、非易失性存储介质及电子设备
CN117100197B (zh) * 2023-10-23 2024-02-20 杭州堃博生物科技有限公司 鞘管调弯方法、装置、非易失性存储介质及电子设备
CN119587141A (zh) * 2024-12-05 2025-03-11 首都医科大学附属北京安贞医院 肥厚梗阻性心肌病消融装置和消融方法

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