CN115025365A - Adjustable bent catheter - Google Patents

Adjustable bent catheter Download PDF

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Publication number
CN115025365A
CN115025365A CN202210662468.1A CN202210662468A CN115025365A CN 115025365 A CN115025365 A CN 115025365A CN 202210662468 A CN202210662468 A CN 202210662468A CN 115025365 A CN115025365 A CN 115025365A
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CN
China
Prior art keywords
catheter
section
bending
proximal
bend
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Pending
Application number
CN202210662468.1A
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Chinese (zh)
Inventor
李�瑞
汤亮
闫伟
李克
龚善石
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.)
Shanghai Interventional Medical Equipment Co ltd
Shanghai Pushi Medical Equipment Co ltd
Original Assignee
Shanghai Interventional Medical Equipment Co ltd
Shanghai Pushi 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.)
Filing date
Publication date
Application filed by Shanghai Interventional Medical Equipment Co ltd, Shanghai Pushi Medical Equipment Co ltd filed Critical Shanghai Interventional Medical Equipment Co ltd
Priority to CN202210662468.1A priority Critical patent/CN115025365A/en
Priority to PCT/CN2022/113541 priority patent/WO2023240787A1/en
Publication of CN115025365A publication Critical patent/CN115025365A/en
Priority to CN202321464478.0U priority patent/CN220424333U/en
Priority to CN202310681063.7A priority patent/CN116570819A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113Mechanical advancing means, e.g. catheter dispensers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses an adjustable bending catheter, which comprises: a handle; the proximal end of the catheter is arranged on the handle, the adjustable bending catheter is provided with a guide channel penetrating through the handle and the catheter, the catheter is provided with a proximal main body section and a distal bending adjusting section, the distal bending adjusting section comprises a first section and a second section, the second section is connected to the distal end of the proximal main body section, the first section is connected to the distal end of the second section, and the hardness of the distal bending adjusting section is lower than that of the proximal main body section; and the bending angle of the distal end bending adjusting section can be adjusted by controlling the bending adjusting line by operating the handle. The operator can operate the handle adjustment the angle of the curved section is transferred to the distal end, adjusts the distal end of pipe and the coaxial state of implanting the position for the apparatus certainly can implant preset position with the state of comparatively adaptation after the distal end of pipe is released, improve and implant the effect.

Description

Adjustable bent catheter
Technical Field
The invention relates to the medical field, in particular to an adjustable bending catheter.
Background
Catheters are common surgical instruments in interventional procedures, and in transcatheter minimally invasive interventional treatment, a catheter is generally required to be implanted to a desired position, such as a heart or a specific blood vessel, through the blood vessel, and then an instrument is implanted to a target position along a channel of the catheter, so as to achieve the purpose of treating the target position.
For the purpose of implanting the instrument, the head end of the catheter usually needs to be coaxially aligned with the target position, and in the prior art, the catheter is usually bent in advance according to the characteristics of the implantation position, so that the distal end of the catheter can be aligned with the target position after reaching a predetermined position.
It should be noted that the tissue morphology of the human body has strong individual variability, and the pre-bending of the distal end of the catheter to a certain shape cannot be applied to the tissues of all patients, and the effect of aligning the distal end of the catheter to the target position is often challenging. For example, when the device is implanted into the left atrial appendage through a catheter, the left atrial appendage may have a complex anatomical shape and have strong individual differences, and the existing catheter may require a long time to adjust for achieving good coaxiality, or in some cases, cannot achieve coaxiality, resulting in prolonged or impossible operation time, thereby posing a high risk to the patient.
Disclosure of Invention
In view of the above technical problems, an object of the present invention is to provide a bendable catheter, wherein an operator can operate a handle to adjust an angle of a distal end bending section at a reasonable speed, so as to realize precise control of a distal end of the catheter, so that the distal end of the catheter is faster and coaxial with various implantation positions, and an implantation instrument can be implanted into a preset position in a relatively adaptive state after being pushed out from the distal end of the catheter, thereby improving implantation efficiency and expanding an application range of the implantation instrument.
To achieve the above object, the present invention provides an adjustable bending catheter, comprising:
a handle;
a catheter having a proximal end mounted to the handle, the bendable catheter having a guide channel extending through the handle and the catheter, the catheter having a proximal body section and a distal bending section, the distal bending section comprising a first section and a second section, the second end being connected to the distal end of the proximal body section, the first section being connected to the distal end of the second section, and the distal bending section having a stiffness lower than the stiffness of the proximal body section;
and the bending angle of the bending section at the far end can be adjusted by controlling the bending line through operating the handle.
In the catheter with adjustable bending provided by the above embodiment, a plane where the central axis of the second section and the central axis of the proximal main body section are located is a reference plane, the distal end of the first section can be pulled by the adjustable bending line to move in a direction away from the reference plane, and after the first section is bent, an included angle between the central axis of the first section and the reference plane ranges from 10 degrees to 60 degrees.
In the adjustable curved catheter provided by the above embodiment, when the first section is in the initial state, the central axis of the first section is located on the reference plane, the adjustable curved line is fixed at the distal end of the first section, a second preset included angle is formed between a plane formed by the distal end point of the adjustable curved line and the central axis of the first section and the reference plane, and the range of the second preset included angle is between 0 ° and 90 °.
In the bendable catheter provided in the above embodiment, the number of the bending lines is two, and when the first segment is in the initial state, distal end points of the two bending lines are located on both sides of the reference plane and are symmetrically arranged with respect to the reference plane.
In the bendable catheter provided in the above embodiment, the bending adjusting wire includes a first bending adjusting wire and a second bending adjusting wire, a distal end of the first bending adjusting wire is fixed to a distal end of the first section, and a distal end of the second bending adjusting wire is fixed to a distal end of the second section;
when the far-end bending adjusting section is in an initial state, an included angle between connecting lines between the far ends of the first bending adjusting lines, the second bending adjusting lines and the central axis of the catheter is in a range of 30-150 degrees;
when the second section is in a bending adjusting state, the included angle between the central axis of the second section and the central axis of the near-end main body section ranges from 30 degrees to 150 degrees.
In the bendable catheter provided by the above embodiment, the first section has a hardness of 35D-55D, the second section has a hardness of 55-65D, and the proximal main body section has a hardness of 75D or more.
In the bendable catheter provided in the above embodiment, a first preset included angle is formed between the central axis of the second segment and the central axis of the proximal main body segment, and the first preset included angle ranges from 30 ° to 60 °.
In the bendable catheter provided in the above embodiment, the handle includes:
the handle comprises a handle main body and a handle, wherein the handle main body is provided with an installation space and a movable hole, and the movable hole is communicated with the installation space;
the receiving mechanism is arranged at the near end of the handle main body;
the bending line adjusting operating mechanism comprises an internal movable block and an external shifting piece, the internal movable block is mounted in the mounting space, the external shifting piece is rotatably mounted on the side wall of the handle main body, at least one part of the external shifting piece penetrates through the movable hole to be in threaded fit connection with the internal movable block, and the external shifting piece is rotated to drive the internal movable block to move along the axial direction of the mounting space;
the built-in movable block is provided with a fixed part, and the near end of the bending adjusting line is fixed on the fixed part;
the built-in movable block is provided with a catheter through hole, the proximal end of the catheter penetrates through the catheter through hole, and the proximal end of the catheter is fixed to the receiving mechanism.
In the bendable catheter provided in the above embodiment, the handle further includes a first limiting rod and a second limiting rod mounted in the mounting space at an interval; the built-in movable block is provided with a first limiting groove and a second limiting groove which are arranged at intervals, the first limiting rod is installed in the first limiting groove, the second limiting rod is installed in the second limiting groove, and the built-in movable block can slide along the first limiting rod and the second limiting rod.
In the bendable conduit provided in the above embodiment, the first limiting groove and the second limiting groove are located on the inner wall of the built-in movable block and are communicated with the conduit through hole.
In the bendable catheter provided in the above embodiment, the handle further includes a support mechanism installed at the distal end of the handle main body, the distal ends of the first limiting rod and the second limiting rod are respectively fixed to the support mechanism, and the proximal ends of the first limiting rod and the second limiting rod are respectively fixed to the receiving mechanism.
In the bendable catheter provided in the above embodiment, the fixing portion of the built-in movable block has an accommodating groove, a distal end sidewall and a proximal end sidewall of the accommodating groove have a distal threading hole and a proximal threading hole respectively communicated with the accommodating groove, and a proximal end of the bendable wire sequentially passes through the distal threading hole, the accommodating groove and the proximal threading hole;
the handle still blocks up including sealing, it has the appearance line groove to seal up to block up, the shutoff stopper install in the holding tank, the near-end of transferring the curved line is located in holding the line groove, rotates the shutoff blocks up can change in holding the line groove transfer the curved line with in the distal end through wires hole transfer the angle between the curved line.
In the bendable catheter provided in the above embodiment, the number of the bending wire operating mechanisms is two or more.
In the bendable catheter provided in the above embodiment, the catheter includes an inner catheter and an outer catheter, and the bending wire is movably installed between the inner catheter and the outer catheter.
In the bendable catheter provided in the above embodiment, the catheter further includes a reinforcing layer located between the inner catheter and the outer catheter, and the reinforcing layer corresponding to the distal bending section has a lower hardness than the reinforcing layer corresponding to the proximal main body section.
In the bendable catheter provided in the above embodiment, the reinforcing layer includes a metal wire wound orderly around the outer sidewall of the inner catheter, and the density of the metal wire corresponding to the distal bending section is lower than that of the metal wire corresponding to the proximal main body section.
In the bending-adjustable catheter provided in the above embodiment, in a plane projection through an axis of the catheter, an included angle between the wires corresponding to the proximal main body segment is less than 60 °, and an included angle between the wires corresponding to the distal bending-adjustable segment is greater than 60 °.
In the bendable catheter provided in the above embodiment, the number of layers of the metal wires of the reinforcing layer corresponding to the proximal main body segment is greater than the number of layers of the metal wires corresponding to the distal bending segment.
In the bendable catheter provided in the above embodiment, the bending line extends in a curved line along the axial direction of the catheter.
Compared with the prior art, the adjustable bent conduit provided by the invention has at least one of the following beneficial effects:
1. according to the bending-adjustable catheter provided by the invention, an operator can operate the handle to adjust the angle of the far-end bending-adjusting section and adjust the coaxial state of the far end of the catheter and the implantation position, so that an instrument can be implanted into a preset position in a relatively adaptive state after being pushed out from the far end of the catheter, and the implantation effect is improved;
2. according to the bending-adjustable guide pipe provided by the invention, the first limiting rod and the second limiting rod can be used as guide rails for the sliding of the internal movable block, and on the other hand, the first limiting rod and the second limiting rod which are arranged at intervals can also prevent the internal movable block from rotating along with the external stirring piece, so that the stability of the axial movement of the internal movable block is improved;
3. according to the bending-adjustable catheter provided by the invention, the position of the far end of the bending-adjusting wire fixed on the far end bending-adjusting section is not positioned at the maximum distance from the reference plane, and the pulling force actually acting on the far end bending-adjusting section is reduced when the far end of the far end bending-adjusting section is under the pulling force of the bending-adjusting wire, so that the phenomenon that the far end bending angle of the far end bending-adjusting section is too fast can be avoided, the stability of the operation process is improved, and the risk of accidentally injuring intracardiac tissues is reduced.
Drawings
The above features, technical features, advantages and modes of implementing the present invention will be further described in the following detailed description of preferred embodiments in a clearly understandable manner by referring to the accompanying drawings.
FIG. 1 is a diagram of an application of a steerable catheter in accordance with a preferred embodiment of the present invention;
FIG. 2 is a perspective view of an adjustable bend catheter in accordance with a preferred embodiment of the present invention;
FIG. 3 is a perspective view of a variant embodiment of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 4 is a schematic structural view of a catheter of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 5 is a schematic structural view of a modified embodiment of the catheter of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 6 is a schematic structural view of a modified embodiment of the catheter of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 7 is a schematic structural view of a modified embodiment of the catheter of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 8 is a perspective view of a second preferred embodiment of the adjustable bend conduit according to the present invention;
FIG. 9 is a schematic view of the direction of bending of the catheter of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 10 is a schematic view of the bend angle of the adjustable bend conduit according to the preferred embodiment of the present invention;
FIG. 11 is a schematic diagram of the position of the deployment of the bend wires of the bend adjustable catheter according to the preferred embodiment of the present invention;
FIG. 12 is a schematic view of a modified embodiment of the placement position of the bend wires of the bend adjustable catheter according to the preferred embodiment of the present invention
FIG. 13 is a schematic perspective view of a bendable catheter according to a third preferred embodiment of the present invention;
FIG. 14 is a schematic view of the distal end arrangement of the bend line of the bend-adjustable catheter of the third preferred embodiment of the present invention;
FIG. 15 is a schematic structural view of the handle of the adjustable bending catheter in accordance with the preferred embodiment of the present invention;
FIG. 16 is a cross-sectional view taken along line A-A of FIG. 15;
FIG. 17 is a schematic view of the internal structure of the handle of the adjustable bending catheter in accordance with the preferred embodiment of the present invention;
FIG. 18 is a perspective view of a plug of the handle of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 19 is a perspective view of the hemostasis valve and receiving mechanism of the handle of the adjustable bend catheter of the preferred embodiment of the present invention;
FIG. 20 is a cross-sectional view taken along line B-B of FIG. 19;
fig. 21 is an enlarged view at a in fig. 20.
The reference numbers illustrate:
the handle 10, the handle body 11, the installation space 111, the movable hole 112, the receiving mechanism 12, the distal receiving groove 121, the proximal receiving groove 122, the communicating channel 123, the bend-adjusting wire-pulling operation mechanism 13, the internal movable block 131, the fixing portion 1311, the catheter perforation 1312, the external toggle member 132, the receiving groove 133, the distal threading hole 134, the proximal threading hole 135, the first stopper rod 141, the second stopper rod 142, the first stopper groove 151, the second stopper groove 152, the support mechanism 16, the stopper 17, the wire receiving groove 170, the hemostatic valve 18, the spiral groove 180, the pushing portion 181, the flow blocking member 182, the external support arm 183, the internal support arm 184, the stopper groove 185, the first stopper arm 186, the second stopper arm 187, the third stopper arm 188, the pressing member 189, the flush joint 19, the catheter 20, the proximal body section 21, the reference plane 213, the distal bend-adjusting section 22, the first section 221, the second section 222, the fixing element 23, the first fixing element 231, a second fixation element 232, an inner catheter 241, an outer catheter 242, a reinforcement layer 243, an inner spring 2431, an outer wrap wire 2432, a bend adjustment wire 30, a first bend adjustment wire 31, a second bend adjustment wire 32, and a guide channel 100.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.
For the sake of simplicity, only the parts relevant to the invention are schematically shown in the drawings, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".
It should be further understood that the term "and/or" as used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.
In this context, it is to be understood that, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.
Referring to fig. 1 to 21 of the drawings, the adjustable bending catheter of the preferred embodiment of the present invention comprises a handle 10, a catheter 20 and an adjustable bending wire 30. The proximal end of the catheter 20 is mounted to the handle 10, the adjustable bending catheter has a guide channel 100 passing through the handle 10 and the catheter 20, the catheter 20 has a proximal body section 21 and a distal bending section 22, the distal bending section 22 is located at the distal end of the proximal body section 21, and the hardness of the distal bending section 22 is lower than that of the proximal body section 21. The far end of transferring curved line 30 is fixed in the curved section 22 is transferred to the far end, the near-end connect in handle 10, the operation handle 10 can control transfer curved line 30 adjusts the bending angle of curved section 22 is transferred to the far end to the biggest axial motion distance sets up the biggest turn angle of curved section 22 is transferred to the far end.
The distal tuning section 22 further comprises a first section 221 and a second section 222. The second section 222 is connected to the distal end of the proximal body section 21, the first section 221 is connected to the distal end of the second section 222, the bending wire 30 may be one or more, and the distal end of the bending wire 30 may be fixed to the distal end of the first section 221 and/or the distal end of the second section 222.
Further, a plane where the central axis of the second segment 222 and the central axis of the proximal main body segment 21 are located is a reference plane 213, and the distal end of the first segment 221 can be pulled by the bending adjustment line 30 to move in a direction away from the reference plane 213. In the bent state, an included angle b between the central axis of the first segment 221 and the reference plane 213 ranges from 10 ° to 60 °, and preferably ranges from 20 ° to 50 °.
Preferably, in the process of operating the handle 10 to control the bending adjustment line 30 to adjust the bending of the distal bending adjustment section 22, an included angle range between the distal end of the distal bending adjustment section 22 and the proximal main body section 21 is changed within a certain three-dimensional range, so that the requirements of various angle adjustments can be met.
The adjustable bending catheter provided by the application is preferably suitable for establishing a channel of the left atrial appendage implantation instrument through a blood vessel and can also be used as a channel for carrying out an intervention operation on other tissues of a human body, and the specific application scene of the adjustable bending catheter should not constitute a limitation on the application.
In one use scenario, the distal end of catheter 20 of the curvable catheter is adapted to enter the right atrium via the inferior vena cava, and after reaching the left atrium through the interatrial septum, the distal end of catheter 20 is placed in an implantation position near the left atrial appendage. The included angle between the inferior vena cava and the atrial septum is an acute angle, the position angle between the atrial septum puncture point and the left auricle is larger in individual difference range, and therefore the distal end of the adjustable bent catheter needs to be set to be a navigation angle so as to reach the left auricle more efficiently and be in a coaxial state with the left auricle, and meanwhile, the operation safety needs to be considered. In this application, the distal end of pipe 20 passes through the atrium interval after, the operator can operate handle 10 adjusts with reasonable speed the angle of distal end turn section 22, the adjustment the distal end of pipe 20 and the coaxial state of implanting the position for the apparatus certainly can implant preset position with the state of comparatively adapting after the distal end of pipe 20 is released, improve and implant efficiency.
The distal end of the distal bending adjusting section 22 is provided with a fixing element 23, and the distal end of the bending adjusting wire 30 is fixed on the fixing element 23. Preferably, the fixation element 23 is a metal ring fixed to the distal tuning section 22. Optionally, the fixation element 23 is integrally formed with the distal tuning bend section 22.
The far-end bending adjusting section 22 has certain elasticity, when the far-end bending adjusting section 22 is under the action of the pulling force of the bending adjusting line 30, the far-end bending adjusting section 22 bends towards the near end, and after the pulling force of the bending adjusting line 30 disappears, the far-end bending adjusting section 22 restores to a natural form.
Preferably, the bend-adjusting wire 30 extends from the fixing member 23 to the proximal end in a straight line along the catheter 20, and is connected to the handle 10 together with the proximal end of the catheter 20. Referring to fig. 5, in a modified embodiment, the bending adjustment line 30 extends along the axial direction of the catheter 20 in a curve, so that when the bending adjustment line 30 is subjected to an external pulling force, the pulling force can be more easily dispersed along the radial direction of the catheter 20, and the distal bending adjustment section 22 can be formed into a softer bending state.
The bending adjusting line 30 can bear a tensile force of more than 5N. Preferably, the bend adjusting line 30 is a wire.
Further, the conduit 20 includes an inner conduit 241 and an outer conduit 242. The bend line 30 is movably mounted between the inner conduit 241 and the outer conduit 242.
The hardness of the outer conduit 242 corresponding to the distal bending section 22 is 35D to 55D, the hardness of the outer conduit 242 corresponding to the proximal main body section 21 is 55D to 75D, and the hardness of the inner conduit 241 corresponding to the distal bending section 22 and the proximal main body section 21 is the same, so that the hardness of the distal bending section 22 is lower than that of the proximal main body section 21.
Referring to fig. 6, in a variant embodiment, the catheter 20 further comprises a reinforcement layer 243 between the inner catheter 241 and the outer catheter 242, the reinforcement layer 243 corresponding to the distal bending section 22 having a lower stiffness than the reinforcement layer 243 corresponding to the proximal main body section 21.
Preferably, the reinforcing layer 243 comprises a metal wire wound on the outer sidewall of the inner catheter 241, the density of the metal wire corresponding to the distal bending section 22 is lower than that of the metal wire corresponding to the proximal main body section 21, so that the hardness of the reinforcing layer 243 corresponding to the distal bending section 22 is lower than that of the reinforcing layer 243 corresponding to the proximal main body section 21.
Referring to fig. 6 and 7, in a plane projection through the axis of the catheter, the included angle between the wires corresponding to the proximal body segment in the radial direction is less than 60 degrees, preferably not more than 45 degrees, the pitch between the wires is small, the supporting force of the wires in the radial direction is large, and a high-hardness section is formed; in a plane projection passing through the axis of the catheter, the included angle between the metal wires corresponding to the distal bending section is more than 60 degrees, preferably more than 90 degrees, the pitch between the metal wires is larger, and the radial supporting force of the metal wires is reduced to form a low-hardness section. In a variant embodiment, the reinforcement layer 243 is only provided between the inner conduit 241 and the outer conduit 242 corresponding to the proximal body segment. Referring to fig. 7, in another variant embodiment, the number of layers of wires of the reinforcing layer 243 corresponding to the proximal main body segment 21 is greater than the number of layers of wires corresponding to the distal turnup segment 22. Illustratively, the reinforcement layer 243 includes an inner spring 2431 and an outer wrap wire 2432, the inner spring 2431 being covered on the outside of both the proximal body segment 21 and the distal tuning bend segment 22, the outer wrap wire 2432 being wrapped around the outside of the proximal body segment 21 only.
Preferably, the bend line 30 is located between the reinforcement layer 243 and the inner conduit 241. Optionally, in a variant embodiment, the bend line 30 can also be located outside the reinforcement layer 243, between the reinforcement layer 243 and the outer catheter 242.
Referring to fig. 8, in a variant embodiment, the second segment 222 may have a fixed curvature and a first predetermined angle a may be provided between the central axis of the second segment and the central axis of the proximal body segment 21. The first preset included angle a ranges from 30 degrees to 60 degrees, and preferably ranges from 40 degrees to 45 degrees. The second segment 222 is provided at the distal end of the proximal body segment 21, and the angle of the first segment 21 can be changed by rotating the proximal body segment 21.
Referring to fig. 9, the distal end of the first segment 221 can be pulled to move to either the left or the right of the base plane 213, or in a variant embodiment to only one of the sides. Preferably, after the first segment 221 is bent, an included angle b between a central axis of the first segment 221 and the reference plane 213 ranges from 10 ° to 60 °, and preferably ranges from 20 ° to 50 °.
It should be noted that the first segment 221 may also have a certain preset bending angle, the preset bending angle is far away from the reference plane 213, the range of the preset bending angle meets the requirement of the included angle b, and the requirement of the included angle b is met after the bending generated by the bending adjusting line 30 is overlapped. So set up, can further improve the curved efficiency of transferring of transfer curved pipe.
Referring to fig. 11, when the first section 221 of the distal end bending adjusting section 22 is in an initial state, that is, in a straight state, the central axis of the first section 221 is located on the reference plane 213, the bending adjusting line 30 is fixed to the distal end of the first section 221, a second preset included angle c is formed between a plane where the distal end point of the bending adjusting line 30 and the central axis of the first section 221 are located and the reference plane 213, and the range of the second preset included angle c is between 0 ° and 90 °. Because the position where the distal end of the bend adjusting wire 30 is fixed to the first segment 221 is not the position where the distance from the reference plane 213 is the largest, when the distal end of the first segment 221 is under the action of the pulling force of the bend adjusting wire 30, the pulling force actually acting on the first segment 221 is reduced, so that the condition that the bending angle of the distal end of the first segment 221 is too fast can be avoided, the stability of the operation process is improved, and the risk of accidentally injuring the intracardiac tissue is reduced.
The first preset included angle a and the second preset included angle c are approximately in a negative correlation relationship, the first preset included angle a is increased, and the second preset included angle c is decreased; the first preset included angle a is reduced, and the second preset included angle c is increased. Setting the first preset included angle a and the second preset included angle c to be approximately in a negative correlation can help to realize the coaxial state of the distal end bending section 22 and the implantation position.
Referring to fig. 12, in a modified embodiment, the number of the bending lines 30 is two, and when the distal bending section 22 is in the initial state, distal end points of the two bending lines 30 are located on both sides of the reference plane 203, and they may be symmetrically arranged with respect to the reference plane 203. The far-end bending adjusting section 20 can be driven to bend towards two different directions through the two bending adjusting lines 30, and various bending adjusting requirements are met. Optionally, in some variant embodiments, the number of the bend-adjusting lines 30 can also be three or four, so as to further increase the bend-adjusting direction of the distal bend-adjusting section 20, and the specific number of the bend-adjusting lines 30 should not be construed as a limitation to the present application.
Referring to fig. 13, in a variant embodiment, both the first section 221 and the second section 222 are able to bend. The bending adjusting line 30 includes a first bending adjusting line 31 and a second bending adjusting line 32, a distal end of the first bending adjusting line 31 is fixed to a distal end of the first section 221, and a distal end of the second bending adjusting line 32 is fixed to a distal end of the second section 222. In the present modified embodiment, both the first segment 221 and the second segment 222 can be bent, and the angle adjustment of the distal end bent segment 22 can be made more flexible. During use, an operator can first pull the second bend adjusting line 32 proximally to control the second segment 222 to start bending by a preset angle; then the first bending-adjusting wire 31 is pulled proximally to control the first segment 221 to start bending by a preset angle so as to adjust the coaxiality of the distal end of the first segment 221 and the implantation position.
Referring to fig. 14, further, when the distal end bending adjusting section 22 is in the initial state, an included angle d between connecting lines between the distal ends of the first bending adjusting line 31, the second bending adjusting line 32 and the central axis of the distal end bending adjusting section 22 ranges from 30 ° to 150 °, and preferably ranges from 60 ° to 120 °. When the second section 222 is in the bending state, an included angle between a central axis of the second section 222 and a central axis of the proximal main body section 21 ranges from 30 degrees to 150 degrees.
It should be noted that, in some embodiments, the second segment 222 may have a predetermined angle, and the first segment 221 may also have a predetermined angle. So set up, can further improve the accent curved efficiency of transferring curved pipe. Whether the first section 221 and the second section 222 have a preset angle or not should not limit the present invention.
Further, the first section 221 has a hardness less than that of the second section 222, and the second section 222 has a hardness less than that of the proximal body section 21. Specifically, the first section 221 has a hardness of 35D to 55D, the second section 222 has a hardness of 55D to 65D, and the proximal body section 21 has a hardness of 65D or more.
The distal end of the first section 221 is provided with a first fixing element 231, the distal end of the second section 222 is provided with a second fixing element 232, the distal end of the first bending adjusting wire 31 is fixed to the first fixing element 231, and the distal end of the second bending adjusting wire 32 is fixed to the second fixing element 232.
Referring to fig. 15 and 16, further, the handle 10 includes a handle body 11, an accommodating and connecting mechanism 12, and a bend-adjusting wire operating mechanism 13. Referring to fig. 2 and 3, the number of the bend adjusting wire operating mechanisms 13 can be one or two, and can also be three or more, and the specific number of the bend adjusting wire operating mechanisms 13 should not be construed as limiting the present application. The handle body 11 has an installation space 111 and a movable hole 112, and the movable hole 112 is communicated with the installation space 111; the receiving mechanism 12 is mounted to the proximal end of the handle body 11. The bend-adjusting operating mechanism 13 includes an internal movable block 131 and an external toggle member 132, the internal movable block 131 is mounted in the mounting space 111, the external toggle member 132 is rotatably mounted on the side wall of the handle body 11, at least a portion of the external toggle member 132 passes through the movable hole 112 and is in threaded fit with the internal movable block 131, and the external toggle member 132 is rotated to drive the internal movable block 131 to move along the axial direction of the mounting space 111. The built-in movable block 131 is provided with a fixed part 1311, and the proximal end of the bending adjusting line 30 is fixed to the fixed part 1311; the built-in movable block 131 is provided with a conduit through hole 1312, the proximal end of the conduit 20 passes through the conduit through hole 1312, and the proximal end of the conduit 20 is fixed on the containing mechanism 12. The distal bending adjustment section 22 has a tendency to return to a natural state when in a bending adjustment state, and a pulling force generated by the returning tendency on the pull wire 30 is not enough to drive the internal movable block 131 and the external toggle member 132 to move relatively, that is, when the distal bending adjustment section 22 is in the bending adjustment state, the external toggle member 132 needs to be rotated by an external force to return to the natural state before bending adjustment.
In the using process, an operator can control the internal movable block 131 to move along the axial direction of the internal movable block in the installation space 111 by rotating the external toggle member 132, so as to drive the bending adjusting line 30 to move, adjust the angle of the distal bending adjusting section 22, and the operation is simple and convenient.
Preferably, the external toggle member 132 and the internal movable block 131 are connected by four-head screw thread fit, so that the bending adjusting efficiency can be greatly increased, and the external toggle member 132 can be set to rotate within one half of a circle to control the distal bending adjusting section 22 to be adjusted to the maximum bending angle. Optionally, the external toggle member 132 and the internal movable block 131 can also be connected in a matching manner through a common thread, a two-end thread or a three-end thread, and the specific thread matching connection manner between the external toggle member 132 and the internal movable block 131 should not be construed as a limitation to the present application.
Referring to fig. 16 and 17, the handle 10 further includes a first stopper rod 141 and a second stopper rod 142 mounted to the mounting space 111 at an interval; the built-in movable block 131 has a first limiting groove 151 and a second limiting groove 152 which are arranged at an interval, the first limiting rod 141 is mounted in the first limiting groove 151, the second limiting rod 142 is mounted in the second limiting groove 152, and the built-in movable block 131 can slide along the first limiting rod 141 and the second limiting rod 142. In the process of rotating the external toggle member 132 to control the axial movement of the internal movable block 131, the first limiting rod 141 and the second limiting rod 142 can be used as guide rails for the sliding of the internal movable block 131, and on the other hand, the first limiting rod 141 and the second limiting rod 142 arranged at intervals can also prevent the internal movable block 131 from rotating along with the external toggle member 132, thereby improving the stability of the axial movement of the internal movable block 131.
Specifically, the first and second limiting grooves 151 and 152 are located on the inner wall of the internal movable block 131 and communicate with the conduit through hole 1312. When the first stopper rod 141 is mounted in the first stopper groove 151, the second stopper rod 142 is mounted in the second stopper groove 152, and the conduit 20 is mounted in the conduit through hole 1312, the conduit 20 is located between the first stopper rod 141 and the second stopper rod 142. Alternatively, in some modified embodiments, the first and second limiting grooves 151 and 152 are respectively located on the outer side wall of the built-in movable block 131, and the first and second limiting rods 141 and 142 are respectively mounted on the inner wall of the mounting space 111.
Further, the handle 10 further includes a supporting mechanism 16 mounted at the distal end of the handle body 11, the distal ends of the first limiting rod 141 and the second limiting rod 142 are respectively fixed to the supporting mechanism 16, and the proximal ends of the first limiting rod and the second limiting rod are respectively fixed to the receiving mechanism 12. The support mechanism 16 can provide support not only for the first stopper rod 141 and the second stopper rod 142, but also for the guide tube 20.
Referring to fig. 17, the fixing portion 1311 of the built-in movable block 131 has a receiving groove 133, distal and proximal side walls of the receiving groove 133 have distal and proximal threading holes 134 and 135 communicating with the receiving groove 133, respectively, and a proximal end of the bending wire 30 passes through the distal threading hole 134, the receiving groove 133 and the proximal threading hole 135 in sequence. The handle 10 further comprises a plug 17, the plug 17 has a line receiving groove 170, the plug 17 is mounted in the receiving groove 133, the proximal end of the bend-adjusting line 30 is located in the line receiving groove 170, and rotating the plug 17 can change the angle, preferably 90 °, between the bend-adjusting line 30 in the line receiving groove 170 and the bend-adjusting line 30 in the distal threading hole 134, so as to tension the bend-adjusting pull line 30, and make the proximal end of the bend-adjusting pull line 30 not move.
Preferably, the diameter of the plug 17 is slightly larger than that of the receiving groove 133, and the plug 17 is fixed in the receiving groove 133 by interference fit. Alternatively, the plug 17 can be fixed in the receiving groove 133 by gluing or welding, and the specific installation manner of the plug 17 should not be construed as limiting the application.
Further, the number of the bend-adjusting wire operating mechanisms 13 is two or more, and the bend-adjusting wire operating mechanisms are respectively correspondingly connected to the proximal ends of the two or more bend-adjusting wires 30 and are respectively used for bending the distal ends of the distal bend-adjusting sections 22 in different directions.
Referring to fig. 15, 16 and 19, further, the handle 10 further includes a hemostatic valve 18 mounted to the proximal end of the receiving mechanism 12.
Referring to fig. 20, the receiving mechanism 12 has a distal receiving groove 121, a proximal receiving groove 122 and a communicating channel 123, wherein the communicating channel 123 communicates the distal receiving groove 121 and the proximal receiving groove 122. The proximal end of the catheter 20 is fixed to the distal accommodating groove 121, the hemostatic valve 18 is mounted on the proximal side of the accommodating mechanism 12, the distal end surface of the hemostatic valve 18 is provided with a spiral groove 180, and the proximal end of the accommodating mechanism 12 is rotatably mounted on the spiral groove 180. The inner wall of the spiral groove 180 forms a pushing portion 181, a flow blocking piece 182 is disposed between the pushing portion 181 and the communication channel 123, the flow blocking piece 182 has a flow blocking hole (not shown), the flow blocking hole is communicated with the communication channel 123, the hemostasis valve 18 is rotated to drive the pushing portion 181 to move to the far end and squeeze the flow blocking piece 182, the flow blocking hole is closed, and the near-end accommodating groove 122 is separated from the far-end accommodating groove 121.
The radial dimension of the communication channel 123 is smaller than the radial dimension of the proximal receiving groove 122, and the sidewall of the communication channel 123 forms a step limiting structure, and abuts against the flow blocking element 182, so as to limit the flow blocking element 182.
Referring to fig. 21, in particular, the hemostatic valve 18 includes a lateral support arm 183 and a medial support arm 184, the lateral support arm 183 and the medial support arm 184 are spaced apart, and a gap therebetween forms the spiral groove 180. The distal end of the medial support arm 184 fits within the proximal receiving slot 122 of the receiving mechanism 12, and the distal end of the medial support arm 184 forms the pushing portion 181.
The choked flow piece 182 is made of an elastic material, and the elastic material includes but is not limited to silica gel, soft PVC, TPE or TPR, etc. When the hemostasis valve 18 is located at the proximal end of the container mechanism 12, the distance between the propelling part 181 and the communication passage 123 is greater than the axial width of the flow blocking part 182; when the hemostatic valve 18 is rotated relative to the receiving mechanism 12 such that the proximal end of the receiving mechanism 12 moves to the bottom of the spiral groove 180, the distance between the propelling part 181 and the communication passage 123 is smaller than the axial width of the obstructing member 182, and the obstructing member 182 is compressed to deform and expand to close the obstructing hole in the radial direction.
Referring to fig. 19, the handle 10 further includes a flush fitting 19 mounted to the receiving mechanism 12 and in communication with the communication channel. It should be noted that after the choke hole is closed, the passage through the catheter 20 is cut off, and the communication channel 123 and the catheter 20 can be flushed, and medicines can be delivered through the flushing connector 19.
Referring to fig. 21, the outer wall of the spiral groove 180 of the hemostatic valve 18 has a limiting groove 185 communicating with the spiral groove 180, the limiting groove 185 has a first limiting arm 186 at the distal end and a second limiting arm 187 at the proximal end, the proximal outer sidewall of the receiving mechanism 12 has a third limiting arm 188 extending radially outward, and the third limiting arm 188 extends into the limiting groove 185. In other words, the inner side surface of the outer support arm 183 forms the stopper groove 185.
The third stopper arm 188 is capable of cooperating with the first stopper arm 186, the second stopper arm 187 to axially stopper when the hemostasis valve 18 rotates relative to the container 12 and moves on the container 12. When the first stopper arm 186 abuts against the third stopper arm 188, the distance between the propulsion portion 181 and the communication passage 123 is large, and the choke hole of the choke piece 182 is in an open state; when the second stopper arm 187 abuts against the third stopper arm 188, the distance between the propulsion portion 181 and the communication passage 123 is small, and the choke hole of the choke piece 182 is in a closed state.
Referring to fig. 20, the hemostasis valve 18 further includes a crimp 189. The capping member 189 is installed in the proximal receiving groove 122, and the capping member 189 is located between the pushing part 181 and the blocking member 182, and the intermediate position of the capping member 189 has a through hole corresponding to the blocking hole. The crimp 189 is fabricated from a relatively rigid material such as, but not limited to, a medical grade modified nylon material. The overlapping member 189 serves to assist the propulsion portion 181 in effectively compressing the choke 182.
The junction between the distal outer side surface and the distal end surface of the receiving means 12 is chamfered. The far end of the accommodating mechanism 12 is provided with a chamfer so as to reduce mechanical damage of the accommodating mechanism 12 to a human body, and the chamfer can be a circular arc chamfer or an oblique chamfer.
It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be construed as the protection scope of the present invention.

Claims (19)

1. An adjustable bend catheter, comprising:
a handle;
a catheter having a proximal end mounted to the handle, the bendable catheter having a guide channel extending through the handle and the catheter, the catheter having a proximal body section and a distal bending section, the distal bending section comprising a first section and a second section, the second section being connected to the distal end of the proximal body section, the first section being connected to the distal end of the second section, and the distal bending section having a stiffness lower than the stiffness of the proximal body section;
and the bending angle of the bending section at the far end can be adjusted by controlling the bending line through operating the handle.
2. The adjustable bending catheter according to claim 1, wherein a plane in which the central axis of the second section and the central axis of the proximal main body section are located is a reference plane, the distal end of the first section can be pulled by the adjustable bending wire to move in a direction away from the reference plane, and after the first section is bent, an included angle between the central axis of the first section and the reference plane ranges from 10 ° to 60 °.
3. The adjustable bending catheter according to claim 2, wherein when the first section is in an initial state, the central axis of the first section is located on the reference plane, the bending wire is fixed to the distal end of the first section, a second preset included angle is formed between a plane where the distal end point of the bending wire and the central axis of the first section are located and the reference plane, and the second preset included angle ranges from 0 ° to 90 °.
4. The adjustable bending catheter according to claim 3, wherein the number of the bending lines is two, and distal end points of the two bending lines are located on both sides of the reference plane and are symmetrically arranged with respect to the reference plane when the first segment is in the initial state.
5. The adjustable bend catheter of claim 2, wherein the bend-adjusting wire comprises a first bend-adjusting wire and a second bend-adjusting wire, a distal end of the first bend-adjusting wire being secured to a distal end of the first section, and a distal end of the second bend-adjusting wire being secured to a distal end of the second section;
when the far-end bending adjusting section is in an initial state, the included angle range between connecting lines between the far end of the first bending adjusting line, the far end of the second bending adjusting line and the central axis of the catheter is 30-150 degrees;
when the second section is in a bending state, the included angle between the central axis of the second section and the central axis of the near-end main body section is in the range of 30-150 degrees.
6. The adjustable bend catheter of claim 5, wherein the first section has a durometer between 35D and 55D, the second section has a durometer between 55D and 65D, and the proximal body section has a durometer above 75D.
7. The adjustable bend catheter according to claim 3 or 5, wherein a first predetermined angle is formed between the central axis of the second segment and the central axis of the proximal main body segment, and the first predetermined angle is in a range of 30 ° to 60 °.
8. The adjustable bend catheter according to any one of claims 1-6, wherein the handle comprises:
the handle comprises a handle main body and a handle, wherein the handle main body is provided with an installation space and a movable hole, and the movable hole is communicated with the installation space;
the receiving mechanism is arranged at the near end of the handle main body;
the bending line adjusting operating mechanism comprises an internal movable block and an external shifting piece, the internal movable block is mounted in the mounting space, the external shifting piece is rotatably mounted on the side wall of the handle main body, at least one part of the external shifting piece penetrates through the movable hole to be in threaded fit connection with the internal movable block, and the external shifting piece is rotated to drive the internal movable block to move along the axial direction of the mounting space;
the built-in movable block is provided with a fixed part, and the near end of the bending adjusting line is fixed on the fixed part;
the built-in movable block is provided with a catheter through hole, the proximal end of the catheter penetrates through the catheter through hole, and the proximal end of the catheter is fixed to the receiving mechanism.
9. The adjustable bend catheter of claim 8, wherein the handle further comprises a first stop bar and a second stop bar mounted in the mounting space at an interval; the built-in movable block is provided with a first limiting groove and a second limiting groove which are arranged at intervals, the first limiting rod is installed in the first limiting groove, the second limiting rod is installed in the second limiting groove, and the built-in movable block can slide along the first limiting rod and the second limiting rod.
10. The adjustable bend conduit according to claim 9, wherein the first and second retaining grooves are located on an inner wall of the internal movable block and communicate with the conduit bore.
11. The adjustable bend catheter of claim 10, wherein the handle further comprises a support mechanism mounted at the distal end of the handle body, the distal ends of the first and second limiting rods are respectively fixed to the support mechanism, and the proximal ends of the first and second limiting rods are respectively fixed to the receiving mechanism.
12. The adjustable bending catheter according to claim 8, wherein the fixing portion of the built-in movable block has a receiving groove, a distal end side wall and a proximal end side wall of the receiving groove have a distal threading hole and a proximal threading hole respectively communicating with the receiving groove, and a proximal end of the adjustable bending wire passes through the distal threading hole, the receiving groove and the proximal threading hole in this order;
the handle still blocks up including sealing, it has the appearance line groove to seal up to block up, the shutoff stopper install in the holding tank, the near-end of transferring the curved line is located in holding the line groove, rotates the shutoff blocks up can change in holding the line groove transfer the curved line with in the distal end through wires hole transfer the angle between the curved line.
13. The adjustable bend catheter of claim 8, wherein the number of bend wire operating mechanisms is two or more.
14. The adjustable bend catheter according to any one of claims 1-5, 9-13, wherein the catheter comprises an inner catheter and an outer catheter, the bend line being movably mounted between the inner catheter and the outer catheter.
15. The adjustable bend catheter of claim 14, further comprising a stiffening layer between the inner catheter and the outer catheter, the stiffening layer corresponding to the distal bend segment having a lower stiffness than the stiffening layer corresponding to the proximal main segment.
16. The adjustable bend catheter of claim 15, wherein the reinforcing layer comprises wires wound in an orderly manner around the outer sidewall of the inner catheter, the wires corresponding to the distal bending section having a density lower than the wires corresponding to the proximal main body section.
17. The adjustable bending catheter according to claim 16, wherein in a planar projection through an axis of the catheter, an included angle between the wires corresponding to the proximal main body segment is less than 60 °, and an included angle between the wires corresponding to the distal bending segment is greater than 60 °.
18. The adjustable bend catheter of claim 16, wherein the proximal main body segment has a greater number of layers of wires than the distal bend segment.
19. The adjustable bending catheter according to any one of claims 1-5 and 9-13, wherein the bending line extends curvilinearly in an axial direction of the catheter.
CN202210662468.1A 2022-06-13 2022-06-13 Adjustable bent catheter Pending CN115025365A (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN202210662468.1A CN115025365A (en) 2022-06-13 2022-06-13 Adjustable bent catheter
PCT/CN2022/113541 WO2023240787A1 (en) 2022-06-13 2022-08-19 Bending-adjustable catheter
CN202321464478.0U CN220424333U (en) 2022-06-13 2023-06-09 Adjustable curved conduit
CN202310681063.7A CN116570819A (en) 2022-06-13 2023-06-09 Adjustable curved conduit

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CN202210662468.1A CN115025365A (en) 2022-06-13 2022-06-13 Adjustable bent catheter

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CN202310681063.7A Pending CN116570819A (en) 2022-06-13 2023-06-09 Adjustable curved conduit
CN202321464478.0U Active CN220424333U (en) 2022-06-13 2023-06-09 Adjustable curved conduit

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CN202321464478.0U Active CN220424333U (en) 2022-06-13 2023-06-09 Adjustable curved conduit

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CN116271422A (en) * 2023-03-29 2023-06-23 极限人工智能有限公司 Catheter for vascular intervention robot and vascular intervention robot
CN116636854A (en) * 2023-05-12 2023-08-25 心诺普医疗技术(北京)有限公司 Three-dimensional curved mapping catheter
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CN116983077B (en) * 2023-07-06 2024-05-28 上海玮启医疗器械有限公司 Pulse ablation catheter capable of realizing multistage bending adjustment

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CN116983077B (en) * 2023-07-06 2024-05-28 上海玮启医疗器械有限公司 Pulse ablation catheter capable of realizing multistage bending adjustment

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CN220424333U (en) 2024-02-02
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