CN116407741A - Adjustable curved conduit - Google Patents

Adjustable curved conduit Download PDF

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Publication number
CN116407741A
CN116407741A CN202111668167.1A CN202111668167A CN116407741A CN 116407741 A CN116407741 A CN 116407741A CN 202111668167 A CN202111668167 A CN 202111668167A CN 116407741 A CN116407741 A CN 116407741A
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CN
China
Prior art keywords
bevel gear
traction wire
sheath
driving mechanism
wire
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.)
Pending
Application number
CN202111668167.1A
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Chinese (zh)
Inventor
刘晓颖
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.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
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Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to CN202111668167.1A priority Critical patent/CN116407741A/en
Priority to PCT/CN2022/137948 priority patent/WO2023124904A1/en
Publication of CN116407741A publication Critical patent/CN116407741A/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
    • A61M25/0133Tip steering devices
    • A61M25/0147Tip steering devices with movable mechanical means, e.g. pull wires
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • 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
    • A61M25/0133Tip steering devices
    • A61M25/0136Handles therefor
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16HGEARING
    • F16H1/00Toothed gearings for conveying rotary motion
    • F16H1/02Toothed gearings for conveying rotary motion without gears having orbital motion
    • F16H1/20Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members
    • F16H1/22Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members with a plurality of driving or driven shafts; with arrangements for dividing torque between two or more intermediate shafts
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16HGEARING
    • F16H1/00Toothed gearings for conveying rotary motion
    • F16H1/02Toothed gearings for conveying rotary motion without gears having orbital motion
    • F16H1/20Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members
    • F16H1/22Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members with a plurality of driving or driven shafts; with arrangements for dividing torque between two or more intermediate shafts
    • F16H1/222Toothed gearings for conveying rotary motion without gears having orbital motion involving more than two intermeshing members with a plurality of driving or driven shafts; with arrangements for dividing torque between two or more intermediate shafts with non-parallel axes
    • 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
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0063Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • 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
    • A61M25/0133Tip steering devices
    • A61M25/0147Tip steering devices with movable mechanical means, e.g. pull wires
    • A61M2025/015Details of the distal fixation of the movable mechanical means
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/32General characteristics of the apparatus with radio-opaque indicia

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

Abstract

The invention relates to the technical field of interventional medical instruments, and provides an adjustable curved catheter which comprises a sheath tube, a shell arranged at the proximal end of the sheath tube, a driving mechanism and a stopping piece arranged in the shell, and at least one traction wire, wherein the distal end of the traction wire is connected with the distal end of the sheath tube, the proximal end of the traction wire stretches into the shell and is connected with the driving mechanism, the driving mechanism is used for pulling and releasing the traction wire to realize the bending of the sheath tube, and the stopping piece is abutted with the driving mechanism and is in interference fit with the driving mechanism, so that the driving mechanism is static relative to the shell under the action of no external force and moves relative to the shell under the action of external force, and the moving driving mechanism changes the bending state of the sheath tube in the process of pulling and releasing the traction wire. When the sheath is in a bending state, the sheath can be kept in the original bending state under the action of no other external force, an additional locking structure is not needed, and the effects of stopping at any time and stopping when the hand is loosened are achieved when bending is adjusted.

Description

Adjustable curved conduit
Technical Field
The invention relates to the technical field of interventional medical instruments, in particular to an adjustable bent catheter.
Background
The intravascular technique is an emerging medical method for minimally invasive treatment of lesions in vivo by means of a catheter moving along a vascular lumen to a lesion site (such as coronary artery, carotid artery, celiac artery, renal artery, etc.), and then by implanting stents or drugs or other implantation instruments, wherein the catheter is an in vitro-to-in-vivo tool established by an endoluminal procedure, playing a vital role. Because of the variability and complexity of the opening positions of peripheral blood vessels of all levels, such as iliac arteries, femoral arteries, common carotid arteries, innominate stems, coronary arteries and the like, and aortic blood vessels, certain difficulty is brought to accurate position determination. Most catheter heads are preformed into different curved shapes, such as a turner sheath, a shuttle sheath, a bending sheath and the like, according to the characteristics of a blood vessel path at a target lesion position. However, when a plurality of vascular diseases or diseases complicated in vascular anatomy are to be treated, a large number of catheters are required to be prepared, and the consumption of instruments and the operation time are increased.
In order to solve the above problems, there is an adjustable bend catheter in the market, and a section of the distal end of the adjustable bend catheter is adjustable, so that the applicability of the adjustable bend catheter can be increased, and the need of selecting the type of the catheter in a great amount of time in the operation process is avoided.
However, the bending-adjustable catheter in the current market usually needs an additional locking structure to perform bending adjustment and fixation during bending adjustment, or can be stopped after reaching a certain limiting angle, and cannot be bent according to the actual situation of the operation process.
Disclosure of Invention
Based on the above, the invention provides the adjustable bending catheter, which solves the problems that the conventional adjustable bending catheter in the market usually needs an additional locking structure to perform bending adjustment and fixation or can be stopped after reaching a certain limiting angle, and can not perform bending adjustment according to the actual situation of the operation process.
The invention provides an adjustable bending catheter, which comprises a sheath tube, a shell arranged at the proximal end of the sheath tube, a driving mechanism and a stopping piece arranged in the shell, and at least one traction wire, wherein the distal end of the traction wire is connected with the distal end of the sheath tube, the proximal end of the traction wire stretches into the shell and is connected with the driving mechanism, the driving mechanism is used for pulling and releasing the traction wire to realize bending of the sheath tube, the stopping piece is abutted with the driving mechanism and is in interference fit with the driving mechanism, so that the driving mechanism is static relative to the shell under the action of no external force and moves relative to the shell under the action of external force, and the moving driving mechanism changes the bending state of the sheath tube in the process of pulling and releasing the traction wire.
Compared with the prior art, the adjustable bending catheter provided by the invention has the following beneficial effects:
according to the adjustable bent catheter provided by the invention, the distal end of the traction wire is connected with the distal end of the sheath tube, the proximal end of the traction wire stretches into the shell and is connected with the driving mechanism, and meanwhile, the stop piece is arranged to be abutted with the driving mechanism and in interference fit with the driving mechanism, so that the driving mechanism moves relative to the shell under the action of external force, the traction wire can be pulled and released to change the bending state of the sheath tube when the driving mechanism moves, and the traction wire is static relative to the shell under the action of non-external force, namely, the sheath tube can be kept in the original bending state under the action of no other external force. In the field of interventional medical instruments, when a doctor performs an operation by using an adjustable bent catheter, due to the complexity of a vascular path, precise control of an angle is particularly important when performing bending adjustment of a sheath. In addition, doctors must contend with each other in operation, operation convenience is important, and if additional locking structures are needed for matching, on one hand, the angle of the adjusted sheath tube is easily affected, on the other hand, a plurality of doctors are needed for matching, and the matching synchronism is also required. The bending-adjustable catheter does not need to be provided with an additional locking structure, can achieve the effects of stopping at any time and stopping immediately after the hands are loosened when bending is adjusted, accurately controls the bending angle, saves the time of operation of doctors and improves the operation convenience.
Drawings
FIG. 1 is a schematic diagram of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 2 is a schematic view of a structure of an adjustable bend catheter according to a first embodiment of the present invention with a sheath core removed;
FIG. 3 is a schematic view of a portion of a shell of a catheter with a sheath core and shell removed according to a first embodiment of the invention;
FIG. 4 is a schematic view of a sheath core of an adjustable catheter according to an embodiment of the present invention;
FIG. 5 is a schematic view illustrating an internal structure of a sheath of an adjustable catheter according to an embodiment of the present invention;
FIG. 6 is a schematic view of a first developing ring of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 7 is a schematic view showing a developing state of a first notch of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 8 is a schematic diagram showing a developing state of a second notch of the bendable catheter according to the first embodiment of the present invention;
FIG. 9 is a schematic view of an anchoring ring of an adjustable bend catheter according to a first embodiment of the present invention;
FIG. 10 is a schematic view showing a combination of an anchor ring and a pull wire of an adjustable bend catheter according to a first embodiment of the present invention;
FIG. 11 is a second schematic view of a combination of an anchor ring and a pull wire of an adjustable bend catheter according to an embodiment of the present invention;
FIG. 12 is a third schematic view of a combination of an anchor ring and a pull wire of an adjustable bend catheter according to an embodiment of the present invention;
FIG. 13 is a fourth schematic view of a combination of an anchor ring and a pull wire of an adjustable bend catheter according to an embodiment of the present invention;
FIG. 14 is a schematic view of a modified embodiment of a sheath of an adjustable bend catheter according to an embodiment of the present invention;
FIG. 15 is a schematic view of an assembled driving mechanism and an adjusting member of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 16 is a schematic view of a structure of a tube for adjusting a bendable catheter according to an embodiment of the present invention;
fig. 17 is a schematic diagram of a combination of a first driven bevel gear, a second driven bevel gear and a supporting frame of an adjustable bend pipe according to a first embodiment of the present invention;
fig. 18 is a schematic structural view of a support frame of an adjustable bend catheter according to an embodiment of the invention;
FIG. 19 is a schematic view showing the structure of a first driven bevel gear of an adjustable bend pipe according to an embodiment of the present invention;
FIG. 20 is a schematic view showing a combination of a first driven bevel gear and a mantle of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 21 is a schematic view of a jacket of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 22 is a schematic view showing a combination of a tube and a sleeve of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 23 is a schematic view showing a first structure of an adjusting member of an adjustable bend conduit according to the first embodiment of the present invention;
FIG. 24 is a schematic view showing a combination of an adjusting member, a limiting plate and a limiting pin of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 25 is a schematic diagram II of an adjusting component of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 26 is a schematic diagram showing a combination of a limiting plate and a limiting pin of an adjustable bend conduit according to an embodiment of the present invention;
FIG. 27 is a schematic diagram showing a combination of a regulator tube and a supporting member of a bendable catheter according to a second embodiment of the present invention;
FIG. 28 is a schematic view of a bending-adjustable catheter according to a third embodiment of the present invention;
fig. 29 is a schematic structural view of an adjustable bend catheter according to a third embodiment of the present invention;
fig. 30 is a schematic structural diagram of an adjustable bend catheter according to a third embodiment of the present invention.
The attached drawings are used for identifying and describing:
10. an adjustable bend conduit; 11. a housing; 12. a sheath core; 13. a sheath; 14. a driving mechanism; 15. an adjusting member; 16. traction wire; 17. a limiting mechanism; 18. a stop member; 19. a first developing ring; 20. a second developing ring;
101. a T-joint; 102. a hose; 103. a three-way valve; 111. an anti-slip raised line; 112. a protective sleeve; 113. limit rib plates; 121. a sheath core tube; 122. a sheath-core joint; 131. a bendable section; 132. a distal soft segment; 133. a proximal hard segment; 134. an anchor ring; 141. a drive bevel gear; 142. a first driven bevel gear; 143. a second driven bevel gear; 144. a support frame; 145. an adjusting tube; 146. a slide block; 147. a silica gel ring; 151. a key slot; 161. a first traction wire; 162. a second traction wire; 171. a limit stop; 172. a limiting pin; 173. a limiting plate; 181. a limit key; 182. a wire penetrating member; 191. a first notch; 192. a second notch;
1311. A spring structure; 1331. a woven mesh structure; 1341. a through groove; 1342. a partition plate; 1343. a through hole; 1344. a wire passing port; 1421. a gear portion; 1422. a wire spool; 1423. a cover sleeve; 1441. a support ring; 1442. a first rotating shaft; 1443. a second rotating shaft; 1451. a limiting piece; 1452. a silica gel gasket; 1453. a connecting key;
14221. a reel; 14222. a first breast board; 14223. a second breast board; 14224. a threading opening; 14231. an opening;
q, accommodating the inner cavity; r, rotating space.
Detailed Description
In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment. It should be noted that, in this embodiment, terms of left, right, up, down, etc. are merely relative concepts or references to normal use states of the product, and should not be construed as limiting.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
In the field of interventional medical devices, the end of the medical device implanted in the human or animal body that is closer to the operator is generally referred to as the "proximal end", the end that is farther from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined in accordance with this principle. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle.
Example 1
Referring to fig. 1-4, an embodiment of the present invention provides an adjustable catheter 10, where the adjustable catheter 10 includes a housing 11, a sheath core 12, a sheath tube 13, a driving mechanism 14, a stop member 18 and at least one traction wire 16, where the sheath core 12 has an inner cavity through which a guide wire can pass, the sheath core 12 is accommodated in the sheath tube 13, a distal end of the sheath core 12 passes through the sheath tube 13, the housing 11 is disposed at a proximal end of the sheath tube 13, the housing 11 has an accommodating cavity q, and the driving mechanism 14 and the stop member 18 are disposed in the accommodating cavity q. The distal end of the traction wire 16 is connected to the distal end of the sheath 13, the proximal end of the traction wire 16 extends into the housing 11 and is connected to the drive mechanism 14, the drive mechanism 14 is used to pull and release the traction wire 16 to effect bending of the sheath 13, and the stop member 18 abuts and is in interference fit with the drive mechanism 14 to allow the drive mechanism 14 to be stationary relative to the housing 11 under no external force and to move relative to the housing 11 under external force, the moving drive mechanism 14 changing the bending state of the sheath 13 during pulling and releasing of the traction wire 16.
Specifically, the casing 11 is used for conveniently holding when operating, and the casing 11 can provide safeguard function and installation support function for parts such as actuating mechanism 14 simultaneously, and casing 11 can be by upper shell and inferior valve butt joint and form accommodation inner chamber q, and further, all can set up anti-skidding sand grip 111 on the surface of upper and lower casing to be convenient for operating personnel to hold. Further, a plurality of reinforcing ribs (not shown) may be provided in the inner wall of the housing 11, and the provision of the reinforcing ribs can enhance the strength of the housing 11 and also provide mounting support functions for the components in the accommodation cavity q of the housing 11.
Further, the proximal end of the sheath 13 is disposed through the housing 11 for connection with the drive mechanism 14 within the receiving cavity q of the housing 11. The distal end of the housing 11 is provided with a protective sleeve 112 at a position where the sheath 13 is abutted, the sheath 13 is penetrated out of the protective sleeve 112, and the protective sleeve 112 is used for preventing the part of the sheath 13 contacted with the protective sleeve 112 from being broken due to overlarge bending angle. Alternatively, the protective sheath 112 may be a silicone protective sheath or a rubber protective sheath.
With continued reference to fig. 3, further, the adjustable bend catheter 10 further includes a T-shaped connector 101, a hose 102 and a three-way valve 103, wherein one end of the T-shaped connector 101 is communicated with the sheath 13, the other end of the T-shaped connector 101 is connected with the three-way valve 103 through the hose 102, and the three-way valve 103 can be connected with a syringe or other apparatus to inject liquid or extract body fluid into the sheath 13.
Specifically, as shown in fig. 4, the sheath core 12 includes a sheath core tube 121 and a sheath core joint 122 provided at a proximal end of the sheath core tube 121, and the sheath core joint 122 is screwed with a proximal end of the sheath tube 13, preferably with a half turn of screw thread. Compared with the mode of clamping the sheath core and the sheath tube in the related art, the invention can bear larger blood flow impact force by the threaded connection mode, and prevent the sheath core 12 from being separated from the sheath tube 13 under the impact of blood flow.
It will be appreciated that when the number of pull wires 16 is 1, the sheath 13 may achieve unidirectional bending, and when the number of pull wires 16 is greater than 1, the sheath 13 may achieve multidirectional bending. For ease of understanding, the embodiments of the present invention are described by way of example in terms of an adjustable bend catheter 10 including two pull wires 16, and should not be construed as limiting the invention. Wherein the two traction wires 16 are a first traction wire 161 and a second traction wire 162, respectively, and the first traction wire 161 and the second traction wire 162 are located at circumferentially different positions of the sheath 13.
It will be appreciated that the driving mechanism 14 may pull and release the first and second pull wires 161, 162, when the driving mechanism 14 pulls either one of the first and second pull wires 161, 162, so that the sheath 13 bends toward the side of the pulled pull wire, and at the same time, the driving mechanism 14 also simultaneously causes the other non-pulled pull wire to release accordingly with the bending of the sheath 13, for example, when the driving mechanism 14 pulls the first pull wire 161 to bend the distal end of the sheath 13 toward the side of the first pull wire 161, the second pull wire 162 releases with the bending of the sheath 13; when the driving mechanism 14 pulls the second pulling wire 162 and drives the sheath 13 to bend towards the side where the second pulling wire 162 is located, the first pulling wire 161 releases the length along with the bending of the sheath 13, so that the sheath 13 can bend in two directions in the bendable section 131 by the mutual cooperation of the driving mechanism 14, the first pulling wire 161 and the second pulling wire 162, and bidirectional bending can be realized. By arranging the sheath tube 13 with the bendable section 131, the first traction wire 161 and the second traction wire 162 anchored on the bendable section 131 of the sheath tube 13, and arranging the driving mechanism 14 for pulling and releasing the first traction wire 161 and the second traction wire 162, when the driving mechanism 14 pulls any one traction wire of the first traction wire 161 and the second traction wire 162, the sheath tube 13 bends towards the side of the pulled traction wire, and simultaneously, the other traction wire synchronously releases, so that the sheath tube 13 can respectively bend in two directions of the sheath tube 13 at the bendable section 131, thereby fully meeting the requirement of interventional therapy on complex lesion positions such as vessel distortion, vessel opening position and the like, greatly reducing the frequency of adjusting catheters and replacing catheters for a plurality of times by clinical operators, facilitating operation and simultaneously reducing the risk of complications.
Referring to fig. 3 and 5, the sheath 13 includes a bendable section 131, a distal soft section 132 and a proximal hard section 133, wherein the bendable section 131 is located between the distal soft section 132 and the proximal hard section 133, the proximal hard section 133 is located at the proximal end of the sheath 13, the distal soft section 132 is located at the distal end of the sheath 13, and the bendable section 131 is disposed near the distal end of the sheath 13, so that it is ensured that the sheath 13 has a certain rigidity during in-vivo delivery, and thus, contact with and scratch against human tissue is reduced, and at the same time, the purpose that the sheath 13 can be bent at a corresponding position when a lesion tissue needs to establish a bent delivery channel is also ensured.
Specifically, the bendable section 131 has a three-layer structure, an inner layer made of a polymer material such as polytetrafluoroethylene PTFE, a middle layer made of a spring structure 1311, and an outer layer made of a soft polymer material such as polyether block polyamide PEBAX, preferably PEBAX with a hardness of 35D. The bending section 131 adopts a three-layer structure and the middle layer is set as the spring structure 1311, so that the bending section 131 can adjust a larger angle due to the better bending resistance of the spring structure 1311.
Specifically, the distal soft segment 132 is of a double layer construction, with an inner layer of PTFE and an outer layer of PEBAX, preferably PEBAX of 35D hardness. The placement of the distal soft segment 132 allows the sheath 13 to reduce trauma to the vessel.
Specifically, the proximal hard segment 133 is of a three-layer construction, the inner layer is PTFE, the middle layer is a woven mesh construction 1331, and the outer layer is PEBAX, preferably PEBAX of 72D hardness. The three layers of structure and the middle layer of structure 1331 form the proximal hard segment 133, which results in better compliance of the proximal hard segment 133 within the vessel due to the better compliance of the structure 1331.
It will be appreciated that the hardness of the flexible segment 131 and the distal soft segment 132 is less than the hardness of the proximal hard segment 133, such that when the flexible segment 131 is bent, the distal soft segment 132 is not driven to bend, thereby more easily maintaining the distal end of the sheath 13 coaxial with the target site for precise release.
Referring to fig. 5-8, specifically, the sheath 13 is provided with a first developing ring 19 and a second developing ring 20, wherein the second developing ring 20 is disposed at the junction of the distal end of the proximal hard segment 133 and the proximal end of the bendable segment 131 as a developing identification of the initial bending point, and the first developing ring 19 is disposed at the distal end of the bendable segment 131 as a developing identification of the bending angle tracking of the sheath 13. In this embodiment, since the proximal hard segment 133 has the woven mesh structure 1331, the second developing ring 20 is disposed at the junction between the distal end of the proximal hard segment 133 and the proximal end of the bendable segment 131, so as to exert a compressing and shrinking effect on the woven mesh structure 1331 of the proximal hard segment 133.
Specifically, the first notch 191 and the second notch 192 are respectively formed on two opposite sides of the first developing ring 19, the first notch 191 and the second notch 192 are all L-shaped notches with right angles, and the first notch 191 and the second notch 192 have different sizes and/or different notch orientations, i.e. one of the first notch 191 and the second notch 192 is disposed at the proximal end of the first developing ring 19, and the other is disposed at the distal end of the first developing ring 19. Through adopting the mode of three-dimensional development to show first breach 191 and second breach 192, when sheath 13 is towards the direction accent bending of first breach 191, the development state is as shown in fig. 7, and the right angle is in doctor's left hand position, and when sheath 13 is towards the direction accent bending of second breach 192, the development state is as shown in fig. 8, and the right angle is in doctor's right hand position, simultaneously because first breach 191 and second breach 192 size and/or breach orientation are different, therefore the development result is different, and doctor can accurately discern sheath 13's accent bending direction according to this. Of course, the first notch 191 and the second notch 192 may also be notches of other shapes, as long as the first notch 191 and the second notch 192 can be distinguished in the developing state, so that a doctor can accurately distinguish the bending direction of the sheath 13.
With reference to fig. 3, 9 and 10, specifically, a threading channel (not shown in the drawing) penetrating the first traction wire 161 and the second traction wire 162 is provided in the side wall of the sheath 13, so that a special moving channel can be provided for the first traction wire 161 and the second traction wire 162, smooth movement of the first traction wire and the second traction wire is ensured, and meanwhile, protection can be provided for the first traction wire and the second traction wire, and interference from the outside is avoided.
In this embodiment, the distal end of the sheath 13 is fixedly connected to the anchor ring 134, and in this embodiment, the anchor ring 134 is fixed to the bendable section 131, and the first pull wire 161 and the second pull wire 162 are connected to the anchor ring 134.
As a specific embodiment, two through grooves 1341 are formed on the outer peripheral side wall of the anchor ring 134 at intervals, and a partition 1342 is disposed in each through groove 1341, wherein the first traction wire 161 penetrates into one through groove from one side of the partition in the through groove and penetrates out of the through groove from the other side of the partition, and the second traction wire 162 penetrates into the through groove from one side of the partition in the other through groove and penetrates out of the through groove from the other side of the partition. In this way, the first and second pull wires 161, 162 guide the sheath 13 to bend in two different directions on different radial planes of the same circumference of the bendable section 131 of the sheath 13. By this arrangement, the stress impact to which the first traction wire 161 and the second traction wire 162 are subjected can be reduced, thereby ensuring the connection stability with the anchor ring 134, and also enabling the sheath 13 to withstand a larger bending force. Meanwhile, the traction wire can be prevented from protruding out of the surface of the anchoring ring 134, so that the risk of wire leakage or ring leakage and the occurrence of false welding or overspray phenomenon in the process of processing and hot melting the sheath 13 are greatly avoided. In the related art, after the traction wire is folded in half, the traction wire is penetrated out of the anchoring ring from the inside of the anchoring ring or is penetrated into the anchoring ring from the outside of the anchoring ring, so that the connection between the anchoring ring and the traction wire is realized, the anchoring ring is subjected to the shearing stress of the traction wire in the bending adjustment process, the risk that the anchoring ring is broken or the traction wire is broken due to the shearing stress concentration is caused, and the connection mode of the anchoring ring and the traction wire in the embodiment can avoid the breakage of the anchoring ring or the breakage of the traction wire due to the shearing stress concentration.
As another embodiment, referring to fig. 11, two through holes 1343 are provided on the side wall of the anchor ring 134 at intervals, wherein the first traction wire 161 penetrates from one side of one through hole and penetrates from the other side, and the second traction wire 162 penetrates from one side of the other through hole and penetrates from the other side of the through hole. The threading process is simple, the cost is low, and the threading process has high practicability.
As yet another embodiment, referring to fig. 12, four through holes 1343 are provided on the sidewall of the anchor ring 134 at intervals, wherein two through holes 1343 are formed in a group, two ends of the first traction wire 161 are respectively penetrated into the anchor ring 134 from the outside of the anchor ring 134 through two through holes 1343 of one group and then protrude from the anchor ring 134, and two ends of the second traction wire 162 are respectively penetrated into the anchor ring 134 from the outside of the anchor ring 134 through two through holes 1343 of the other group and then protrude from the anchor ring 134. This reduces the stress shock to which the first and second traction wires 161, 162 are subjected, thereby ensuring the stability of their connection to the anchor ring 134 and also enabling the sheath 13 to withstand greater bending forces.
As still another embodiment, referring to fig. 13, four through holes 1343 are spaced apart from each other on the side wall of the anchor ring 134, wherein two through holes 1343 are formed in a group corresponding to each through hole 1343 of the anchor ring 134, two ends of the first traction wire 161 respectively penetrate into the anchor ring 134 from the outside of the anchor ring 134 through two through holes 1343 of one group and then protrude from the corresponding through holes 1344 of the group, and two ends of the second traction wire 162 respectively penetrate into the anchor ring 134 from the outside of the anchor ring 134 through two through holes 1343 of the other group and then protrude from the corresponding through holes 1344 of the group. This reduces the stress shock to which the first and second traction wires 161, 162 are subjected, thereby ensuring the stability of their connection to the anchor ring 134 and also enabling the sheath 13 to withstand greater bending forces. While also avoiding the crossing of the pulling wires on the inner wall of the anchor ring 134 from scratching the membrane of the sheath 13 during pulling of the pulling wires.
Of course, the first pull wire 161 and the second pull wire 162 may also lie in the same radial plane of the anchor ring 134, i.e., the same radial plane of the same circumference of the bendable section 131 of the sheath 13 (not shown). In this way, the first traction wire 161 and the second traction wire 162 can bend in two directions completely opposite to each other on the same circumference of the bendable section 131 of the sheath 13, so that a proper catheter can be selected according to the individual difference of physiological anatomy structures of different patients, and the bending curvature, such as small bend, medium bend and large bend, of the bendable section 131 of the sheath 13 can be adjusted to adapt to the requirements of different human bodies, reduce the puncture times and injuries to the human bodies, simplify the operation process and shorten the operation time.
As another alternative embodiment, referring to fig. 14, two anchoring rings 134 may be disposed on the bendable section 131 of the sheath 13 at intervals, and the first traction wire 161 and the second traction wire 162 are anchored on the two anchoring rings 134 respectively, so that the first traction wire 161 and the second traction wire 162 can draw the sheath 13 in two different directions in radial directions of different circumferential directions of the bendable section 131 of the sheath 13 to bend, which also satisfies clinical requirements, and the structure is particularly suitable for the situation that different sections of the main vascular passageway have bifurcated branch vessels.
Referring to fig. 3, 15 and 16, in particular, the driving mechanism 14 includes a driving member and a driven member, the driving member and the driven member are connected by a bevel gear, the proximal end of the traction wire 16 is connected to the driven member, and the driving member drives the driven member to pull and release the traction wire 16. Wherein, the driving mechanism 14 comprises at least one driven piece, and the driven pieces are in one-to-one correspondence with the traction wires 16; the driving part is a driving bevel gear 141, the driven part is a driven bevel gear meshed with the driving bevel gear 141, the driven bevel gear is connected with a corresponding traction wire, and the driving bevel gear 141 drives the driven bevel gear to pull and release the traction wire connected with the driven bevel gear.
In the embodiment of the invention, the driving member is a driving bevel gear 141, the driven member comprises a first driven member (the first driven member is a first driven bevel gear 142 in the embodiment) in linkage with the driving member and a second driven member (the second driven member is a second driven bevel gear 143 in the embodiment) in linkage with the driving member, the first driven bevel gear 142 is connected with a first traction wire 161, the second driven bevel gear 143 is connected with a second traction wire 162, the driving bevel gear 141 drives any one of the first driven bevel gear 142 and the second driven bevel gear 143 to pull the traction wire connected with the driving bevel gear, and the other one of the first driven bevel gear 142 and the second driven bevel gear 143 is synchronously driven to release the traction wire connected with the driving bevel gear, so that bidirectional bending adjustment can be realized. It should be noted that, in other embodiments, the driving member may also be a worm, the first driven member may be a worm wheel engaged with the worm, and the second driven member may be another worm wheel engaged with the worm.
As a specific embodiment, the driving bevel gear 141 and the sheath 13 are coaxially disposed, the first driven bevel gear 142 and the second driven bevel gear 143 are engaged with the driving bevel gear 141, the first driven bevel gear 142 is connected with the first traction wire 161, the second driven bevel gear 143 is connected with the second traction wire 162, in this embodiment of the invention, the first driven bevel gear 142 and the second driven bevel gear 143 are symmetrically disposed about at least one axial plane of the driving bevel gear 141, that is, the first driven bevel gear 142 and the second driven bevel gear 143 are located at circumferentially different positions of the driving bevel gear 141, so that the driving bevel gear 141, the first driven bevel gear 142 and the second driven bevel gear 143 have relatively stable structural stability and relatively stable transmission property, and simultaneously, when the driving bevel gear 141 drives any one of the first driven bevel gear 142 and the second driven bevel gear 143 to rotate, the traction wire 161 and the second traction wire 162 are correspondingly accommodated or released, and when the driving bevel gear 141 drives any one of the first driven bevel gear 142 and the second driven bevel gear 143 to rotate, the other driven bevel gear 142 and the other driven bevel gear 143 is correspondingly connected with the other driven bevel gear to rotate. In this way, the drive bevel gear 141, the first driven bevel gear 142, the second driven bevel gear 143, the first traction wire 161, and the second traction wire 162 are engaged with each other and linked, so that the sheath 13 can be bent in both directions, and the first traction wire 161 and the second traction wire 162 can be stored and released simultaneously.
More specifically, the rotation center axis of the first driven bevel gear 142 is disposed coaxially with the rotation center axis of the second driven bevel gear 143, and the rotation center axes of the first driven bevel gear 142 and the second driven bevel gear 143 are both perpendicular to the center axis of the drive bevel gear 141. In this way, the radial stress applied to the drive bevel gear 141 by the first and second driven bevel gears 142, 143 in the radial direction will be more balanced, so that the overall bevel gear transmission system is more stable, the transfer of forces will be more balanced, and the synchronicity of the first and second traction wires 161, 162 will be better when pulling and releasing.
In this embodiment, since the first driven bevel gear 142 and the second driven bevel gear 143 are engaged with the driving bevel gear 141, when the driving bevel gear 141 drives the first driven bevel gear 142 and the second driven bevel gear 143 to rotate simultaneously, the rotation directions of the first driven bevel gear 142 and the second driven bevel gear 143 are opposite, at this time, the first traction wire 161 is wound around the first driven bevel gear 142 in a counterclockwise direction, the second traction wire 162 is also wound around the second driven bevel gear 143 in a counterclockwise direction, that is, the winding directions of the first traction wire 161 and the second traction wire 162 are the same (i.e., both winding in a clockwise direction or both winding in a counterclockwise direction), so that the driving of the driving bevel gear 141 can be realized, and when the first traction wire 161 is pulled, the second traction wire 162 is released, and vice versa. At this time, synchronous control to the first traction wire 161 and the second traction wire 162 can be realized through one bevel gear and two driven bevel gears, the structure is compact, the occupied space is small, the requirements that the medical instrument is required to realize accurate control and the volume is not suitable to be too large to be convenient to control can be better met. Of course, in other embodiments, the rotation directions of the first driven bevel gear 142 and the second driven bevel gear 143 are the same, and the winding directions of the first traction wire 161 and the second traction wire 162 are opposite, for example, one of the first traction wire 161 and the second traction wire 162 is wound in a clockwise direction, and the other of the first traction wire 161 and the second traction wire 162 is wound in a counterclockwise direction.
Referring to fig. 17 and 18, further, the driving mechanism 14 further includes a supporting frame 144, where the supporting frame 144 includes a supporting ring 1441, a first rotating shaft 1442, and a second rotating shaft 1443, the first rotating shaft 1442 and the second rotating shaft 1443 are fixedly connected with the supporting ring 1441, the first rotating shaft 1442 and the second rotating shaft 1443 are coaxially arranged, and the first rotating shaft 1442 and the second rotating shaft 1443 are located in the same radial plane of the sheath 13, where the first rotating shaft 1442 is rotationally connected with a central portion of the first driven bevel gear 142, the second rotating shaft 1443 is rotationally connected with a central portion of the second driven bevel gear 143, and a central axis of the driving bevel gear 141 passes through a center of the supporting ring 1441 of the supporting frame 144. In this way, it is structurally ensured that the central axes of the first driven bevel gear 142 and the second driven bevel gear 143 are always on the same central axis, so that the first traction wire 161 and the second traction wire 162 keep synchronous movement as much as possible. As an embodiment, the supporting frame 144 may be made of a metal material with better rigidity, so that the supporting frame can better bear larger radial stress of the first driven bevel gear 142 and the second driven bevel gear 143. In particular, the surface of the first rotary shaft 1442 that is in rotatable contact with the first driven bevel gear 142 is a smoother surface, and the surface of the second rotary shaft 1443 that is in rotatable contact with the second driven bevel gear 143 is also a smoother surface. The "smooth surface" herein means that the roughness is not more than 6.4Ra, the roughness of the rotating contact surfaces of the first rotating shaft 1442 and the first driven bevel gear 142 and the rotating contact surfaces of the second rotating shaft 1443 and the second driven bevel gear 143 is lower, and the friction between the contact surfaces needs to be reduced better, so that the first rotating shaft 1442 and the second rotating shaft 1443 can rotate smoothly relatively, so that the driving force for driving the first rotating shaft 1442 and the second rotating shaft 1443 to rotate is smaller, the purposes of saving time and labor are achieved, and the reliability of the whole driving mechanism 14 can be improved.
As an alternative embodiment of the drive mechanism 14, the drive mechanism 14 may also be provided in the form of two sets of bevel gear assemblies controlling the first and second traction wires 161, 162, respectively. Specifically, in this embodiment, the driving member includes a first driving bevel gear and a second driving bevel gear, where the first driving bevel gear and the second driving bevel gear are coaxially disposed, but are disposed in opposite directions, the first driving bevel gear is disposed in engagement with the first driven bevel gear 142, and the second driving bevel gear is disposed in engagement with the second driven bevel gear 143, when the first driving bevel gear and the second driving bevel gear rotate, their rotation directions are the same, and according to the steering driving rule of the bevel gear pair, the rotation directions of the first driven bevel gear 142 and the second driven bevel gear 143 driven by the bevel gear pair are the same, and at this time, the winding directions of the first traction wire 161 and the first driven bevel gear 142, and the winding directions of the second traction wire 162 and the second driven bevel gear 143 are respectively in opposite directions, so that when any one of the first traction wire 161 and the second traction wire 162 is pulled, the other traction wire is released correspondingly, and then the sheath 13 is subjected to bidirectional bending control.
Referring to fig. 19-21, specifically, the first driven bevel gear 142 includes a gear portion 1421 meshed with the drive bevel gear 141 and a spool 1422 connected to the gear portion 1421, the proximal end of the first traction wire 161 is fixedly connected to the spool 1422, specifically, the spool 1422 includes a cylindrical reel 14221, and a first rail plate 14222 and a second rail plate 14223 protruding from the outer surface of the reel 14221, the first rail plate 14222 and the second rail plate 14223 are disposed at intervals, the first traction wire 161 can be wound on the reel 14221, i.e. a portion between the first rail plate 14222 and the second rail plate 14223, and a threading hole 14224 through which the traction wire passes is formed in the spool 1422. When the first driven bevel gear 142 rotates, the first traction wire 161 fixedly connected to the spool 1422 is driven to retract or relax around the spool 1422, thereby accommodating and releasing the first traction wire 161.
It should be understood that the specific structure of the second driven bevel gear 143 and the connection relationship between the second traction wire 162 and the second driven bevel gear 143 can be designed identically with reference to the structure of the first driven bevel gear 142, and will not be described herein.
Further, a cover sleeve 1423 for limiting the first traction wire 161 is sleeved on the wire spool 1422, an opening 14231 for the first traction wire 161 to pass through is formed in the cover sleeve 1423, more specifically, the cover sleeve 1423 is sleeved on a reel 14221 of the wire spool 1422 and forms an independent space for the first traction wire 161 to wind with the wire spool 1422. The cover sleeve 1423 can limit the first traction wire 161 to move in an independent space enclosed by the wire spool 1422 and the cover sleeve 1423, so that the situation that the first traction wire 161 is deviated from the wire spool 1422 to trip off and is wound on other parts by mistake when in a relaxed state is avoided.
It will be appreciated that a corresponding cover sleeve may be disposed on the second driven bevel gear 143 to avoid the second traction wire 162 from being jammed, which is not described herein.
Referring to fig. 3 and 22, specifically, the driving mechanism 14 includes an adjusting tube 145, a distal end of the adjusting tube 145 is connected with the drive bevel gear 141, the sheath tube 13 is disposed in the adjusting tube 145 in a penetrating manner, a silica gel washer 1452 is sleeved on the adjusting tube 145, and the stop member 18 abuts against and is in interference fit with the silica gel washer 1452, so that friction between the sleeve and the silica gel washer 1452 is increased, and the sheath tube 13 can maintain an original bending state for a long time without other external forces. In the field of interventional medical devices, when a doctor performs an operation using the bending-adjustable catheter 10, precise control of the angle is particularly important when performing bending adjustment of the sheath 13 due to the complexity of the vascular path. In addition, doctors must contend with each other in operation, operation convenience is important, and if additional locking structures are needed for matching, on one hand, the angle of the adjusted sheath tube is easily affected, on the other hand, a plurality of doctors are needed for matching, and the matching synchronism is also required. The bending-adjustable catheter 10 does not need to be provided with an additional locking structure, can achieve the effects of stopping at any time and stopping immediately after the hands are loosened when bending is adjusted, accurately controls the bending angle, saves the time of operation of doctors and improves the operation convenience.
Further, at least one limiting member 1451 is disposed on the adjusting tube 145, the limiting member 1451 is an annular protruding strip protruding from the outer peripheral surface of the adjusting tube 145, the silica gel washer 1452 is sleeved on the annular protruding strip, the stop member 18 is abutted against and in interference fit with the silica gel washer 1452, so that the adjusting tube 145 is static relative to the housing 11 under the action of non-external force and moves relative to the housing 11 under the action of external force, and the moving adjusting tube 145 drives the driving bevel gear 141 to drive the first driven bevel gear 142 and the second driven bevel gear 143 to pull and release the traction wire 16. The stopping member 18 of the present embodiment is a sleeve sleeved on the outer peripheral side of the limiting member 1451, and the sleeve is rotatably sleeved on the silica gel washer 1452, and is abutted against the silica gel washer 1452 and in interference fit therewith. Preferably, the stopper 1451 is integrally formed with the adjustment tube 145.
As another alternative, the stopper 1451 is a sphere protruding from the outer peripheral surface of the adjustment tube 145, against which the stopper 18 abuts and remains stationary relative to the housing 11, which is in interference fit with the stopper 18. The stop member 18 is abutted with the spheroid, so that the adjusting pipe 145 is static relative to the shell 11 under the action of no external force and moves relative to the shell 11 under the action of external force, and the moving adjusting pipe 145 drives the driving bevel gear 141 to drive the first driven bevel gear 142 and the second driven bevel gear 143 to pull and release the traction wire 16. Preferably, the stopper 1451 is integrally formed with the adjustment tube 145.
In an embodiment of the present invention, the drive bevel gear 141 is integrally formed at the distal end of the adjustment tube 145.
According to the adjustable bent catheter 10 provided by the invention, at least one limiting piece 1451 is arranged on the adjusting tube 145, the limiting piece 1451 protrudes out of the outer peripheral surface of the adjusting tube 145, the silica gel washer 1452 is sleeved on the limiting piece 1451, meanwhile, the sleeve is sleeved on the silica gel washer 1452, the sheath tube 13 is penetrated in the adjusting tube 145, the sleeve is kept static relative to the shell 11, the sleeve is in interference fit with the silica gel washer 1452, the adjusting tube 145 is enabled to be static relative to the shell 11 under the action of no external force and move relative to the shell 11 under the action of external force, the moving adjusting tube 145 drives the driving bevel gear 141 to drive the first driven bevel gear 142 and the second driven bevel gear 143 to pull and release the traction wire 16, the driving mechanism 14 moves relative to the shell 11 under the action of external force, the traction wire 16 can be pulled and released to change the bending state of the sheath tube 13 when the driving mechanism 14 moves, and the sheath tube 13 is enabled to be static relative to the shell 11 under the action of no external force, namely the original bending state of the sheath tube 13 can be kept at any time under the action of no other external force, and the effect of stopping and releasing the bending can be achieved at any time when the adjusting is performed. In addition, the limiting piece 1451 protrudes out of the outer circumferential surface of the adjusting tube 145, so that abrasion of the tube wall of the adjusting tube 145 in the process of rotating the adjusting tube 145 relative to the sleeve can be avoided, and the service life of the adjusting tube is prolonged. In addition, the sleeve can also provide radial support for the adjusting tube 145 to enhance the radial stress function of the adjusting tube, so as to overcome the defect that the radial stress is larger in the transmission of the driving mechanism 14.
In this embodiment, two limiting members 1451 are disposed on the adjusting tube 145, that is, two annular ribs are disposed on the outer peripheral surface of the adjusting tube 145, and limiting rib plates 113 that are abutted against the two annular ribs are disposed on the inner wall of the housing 11, and in this embodiment, the two annular ribs may be disposed between the two limiting rib plates 113, and of course, the two limiting rib plates 113 may also be disposed between the two annular ribs (not shown in the figure). By such arrangement, the cooperation of the annular protruding strips and the limiting rib plates 113 limits and positions the forward and backward movement of the adjusting pipe 145 in the axial direction.
As another alternative embodiment, only one stopper 1451 is provided on the adjusting tube 145, that is, an annular protrusion is provided on the outer circumferential surface of the adjusting tube 145, and two stopper ribs 113 for clamping the annular protrusion are provided on the inner wall of the housing 11. By such arrangement, the cooperation of the annular protruding strips and the limiting rib plates 113 limits and positions the forward and backward movement of the adjusting pipe 145 in the axial direction.
Further, two limiting keys 181 for circumferentially limiting the sleeve are symmetrically arranged on the outer peripheral side of the sleeve, supporting ribs (not shown in the figure) which are propped against the two limiting keys 181 in a one-to-one correspondence manner are arranged on the inner wall of the shell 11, so that the sleeve can be limited in the circumferential direction, and the adjustment tube 145 is prevented from driving the sleeve to rotate when rotating.
Referring to fig. 3, 15, 22 and 23, the embodiment of the present invention provides an adjusting component 15 for adjusting the driving mechanism 14, so as to select and adjust the bending direction and the bending angle of the sheath 13. Further, the bendable catheter 10 further comprises an adjusting member 15 connected to the proximal end of the adjusting tube 145, wherein the adjusting member 15 is at least partially exposed to the housing 11, and the adjusting member 15 may be a knob, and the adjusting member 15 drives the driving mechanism 14 to rotate. Thus, the bending direction and the bending angle of the sheath tube 13 in the body can be selected and adjusted to realize bidirectional bending by adjusting the adjusting member 15 in the body for the complex lesion positions of the blood vessel distortion and the blood vessel multiple openings.
Specifically, the regulating member 15 and the regulating pipe 145 are connected by means of a key connection. As a specific embodiment, the proximal end of the adjusting tube 145 is provided with a connecting key 1453, the position of the adjusting member 15 corresponding to the connecting key 1453 is provided with a key slot 151, and the connecting key 1453 of the adjusting tube 145 is matched with the key slot 151 on the adjusting member 15 through keys, so as to realize circumferential fixation and torque transmission of the adjusting tube 145. The adjusting pipe 145 is rotated by rotating the adjusting part 15, and the adjusting pipe 145 is rotated to rotate the driving bevel gear 141, thereby driving the first driven bevel gear 142 and the second driven bevel gear 143 at both sides to perform a reverse rotation motion. The traction wire is crimped and wound on the wire spool of the corresponding driven bevel gear, and as the first driven bevel gear 142 and the second driven bevel gear 143 do reverse rotation, one side of the traction wire is tensioned, the other side of the traction wire is in a relaxed state, and the one side of the traction wire can drive the bendable section 131 of the sheath 13 to bend to a preset angle in one direction by pulling the anchoring ring 134, so that the purpose of bending at one side is achieved. The adjusting member 15 is rotated reversely, the adjusting tube 145 is rotated reversely, the original tension side pulling wire is loosened, and the original loosening side pulling wire is tensioned, thereby achieving reverse bending adjustment.
Preferably, compared with the non-bevel gear meshing mode in the related art, the adjustable bent catheter 10 provided by the invention has the advantages that the handle part adopts the bevel gear meshing mode, so that the size of the handle can be reduced, one-hand operation of a doctor is realized, in the operation requiring bending adjustment of the sheath tube 13, the operation steps of the doctor can be greatly simplified, the operation complexity is reduced, the bending adjustment of the sheath tube 13 can be ensured by one hand of the doctor, the effect of stopping at any time and stopping immediately after releasing the hand can be achieved, the structure is stable and labor-saving, the reaction speed is high, and the bending adjustment delay is greatly reduced.
The adjustable bend conduit 10 of the invention has the advantages of being compact and realizing one-hand operation, and the final ratio of ac/bd is 1:0.6-1:0.1 by properly regulating the diameter a of the wire spool of the driven bevel gear, the diameter b of the driven bevel gear, the diameter c of the driving bevel gear and the diameter d of the regulating component, in other words, the bending force required by an operator in use is greatly reduced, the space inside the shell 11 can be maximally utilized under the ratio range, the operation is most labor-saving, and one-hand operation is facilitated.
In summary, according to the adjustable bend conduit 10 provided by the invention, the proximal end of the adjusting tube 145 is connected with the adjusting component 15, the distal end is connected with the driving bevel gear 141, the adjusting tube 145 is provided with the limiting piece 1451, the limiting piece 1451 is sleeved with the silica gel gasket 1452, the stop piece 18 is abutted against the silica gel gasket 1452 and in interference fit with the silica gel gasket 1452, namely, the stop piece 18 is arranged between the adjusting part at the proximal end of the adjustable bend conduit 10 and the bevel gear meshing driving part at the distal end, so that the effect that the adjustable bend conduit 10 stops at any time and stops when the hand is loosened in the bending adjusting process can be ensured. Meanwhile, compared with the structure of stopping the bending device in the related art, the bending device is arranged at the proximal end of the adjusting component 15 (i.e. the proximal end of the housing 11), the bending adjusting device can enable the bending adjusting of the bending adjustable catheter 10 to be more stable, and the bending adjusting effect is better. Meanwhile, compared with the prior art adopting a self-locking thread form, more strokes are needed when the angle is adjusted, so that the handle is longer in size, and higher risks can be brought in the operation process, the length of the shell 11 of the adjustable bent catheter 10 can be reduced, and the risks brought in the operation process such as the falling of the shell 11 and even the bringing of the sheath 13 out of the patient body can be greatly reduced.
Further, referring to fig. 3 and 24-26, the adjustable bend catheter 10 further includes a stop mechanism 17, the stop mechanism 17 includes two stop blocks 171 and at least one stop pin 172, one of the stop blocks 171 and the stop pins 172 is connected to the adjustment member 15 and rotates synchronously with the adjustment member 15, and the other of the stop blocks 171 and the stop pins 172 is stationary relative to the sheath 13. The two limit stops 171 define a rotation space r (shown by a broken line in fig. 25), and the limit pins 172 rotate relative to the limit stops 171 in the rotation space r.
Specifically, in the present embodiment, the limiting mechanism 17 further includes a limiting plate 173, the limiting plate 173 is disposed opposite to the adjusting member 15 at a distance, and the limiting plate 173 is kept stationary with respect to the sheath 13, the limiting pin 172 is positioned on the limiting plate 173, and the two limit stops 171 are disposed on the adjusting member 15 and rotate synchronously with the adjusting member 15.
Preferably, in the embodiment of the invention, the bending angle is 0-210 degrees.
In the embodiment of the present invention, two limiting pins 172 are disposed on the limiting plate 173, and the two limiting pins 172 may be symmetrically distributed on the limiting plate 173 or asymmetrically distributed on the limiting plate 173 with the short axis of the limiting plate 173 as the symmetry axis. When the limit stops 171 on the adjusting part 15 are symmetrically distributed on the limit plate 173 and rotate to be in contact with the limit pins 172 on the limit plate 173, the adjusting part 15 is limited and stops rotating, the reverse is the same, the limit pins 172 on the two sides are symmetrically distributed, and the two-way bending angle is the same; when the limit pins 172 are asymmetrically distributed on the limit plate 173, the limit stop 171 on the adjusting member 15 rotates to contact with the limit pin 172 on the one side limit plate 173, and the adjusting member 15 is limited, stops rotating, and reverses the same.
Example two
The second embodiment is the same as or similar to the first embodiment, and the main difference between them is that, as shown in fig. 27, the stop member 18 in the second embodiment is an abutment member disposed on the inner wall of the housing 11 and abutting against at least one side of the outer peripheral side of the adjusting tube 145, and the abutment member is in interference fit with the stop member 18.
Further, the abutment abuts against at least one side of the outer peripheral side of the stopper 1451, and the embodiment of the present invention will be described by taking the case that the abutment is disposed on both sides of the stopper 1451 as an example, and should not be limited thereto. When the adjusting tube 145 is disposed in the accommodating cavity q of the housing 11, the abutting member clamps the limiting member 1451, so that the adjusting tube 145 is stationary relative to the housing 11 under the action of no external force and moves relative to the housing 11 under the action of external force, and the moving adjusting tube 145 drives the driving bevel gear 141 to drive the first driven bevel gear 142 and the second driven bevel gear 143 to pull and release the traction wire 16.
According to the adjustable bending catheter 10 provided by the embodiment of the invention, the driving mechanism 14 moves relative to the shell 11 under the action of external force through the abutting fit between the abutting piece and the limiting piece 1451, the traction wire 16 can be pulled and released to change the bending state of the sheath tube 13 when the driving mechanism 14 moves, and the adjustable bending catheter is static relative to the shell 11 under the action of non-external force, namely, under the action of no other external force, the original bending state of the sheath tube 13 can be kept, and the effects of stopping at any time and stopping when the user releases his hands are achieved when bending adjustment is performed.
Example III
The third embodiment is the same as or similar to the first embodiment, and the main difference between them is that, as shown in fig. 28, the driving mechanism 14 of the third embodiment includes a slider 146, the stop member 18 is a sleeve, the sleeve is sleeved on the outer peripheral side of the slider 146, the slider 146 can axially move relative to the sleeve, and a slot (not shown) for sliding the slider 146 is formed on the housing 11.
Specifically, the inner wall of the sleeve is embedded with a silica gel ring 147, and the sliding block 146 is in interference fit with the sleeve through the silica gel ring 147. The pull wire 16 is connected to the slider 146, and in particular to the distal end of the slider 146. Alternatively, a threading member 182, preferably a fixed ring or rotating wheel, may be provided at the bottom of the sleeve, and the pull wire 16 may be coupled to the proximal end of the slider 146 after passing through the slider 146 and threading member 182.
In this embodiment, when the slider 146 is axially moved, the slider 146 pulls and releases the traction wire 16 to change the bending state of the sheath 13, and under the action of no external force, the slider 146 is stationary relative to the housing 11, i.e. under the action of no other external force, the sheath 13 can be kept in the original bending state, and the effects of stopping at any time and stopping when the hand is released are achieved when the bending is adjusted.
Example IV
The fourth embodiment is the same as or similar to the third embodiment, and the main difference between them is that, as shown in fig. 29, the driving mechanism 14 of the fourth embodiment includes two sliding blocks 146 that can slide relatively, the stop member 18 is a sleeve, the sleeve is sleeved on the outer peripheral sides of the two sliding blocks 146, the two sliding blocks 146 can move axially relative to the sleeve, and a slot (not shown) for sliding the two sliding blocks 146 is formed in the housing 11.
Specifically, a silica gel ring 147 is embedded in the inner wall of the sleeve, the two sliding blocks 146 are in interference fit with the sleeve through the silica gel ring 147, and the two sliding blocks 146 can be connected through a guide rail and a sliding groove. The first traction wire 161 is connected to a slider 146, in particular to the distal end of the slider 146. Alternatively, a threading member 182, preferably a fixed ring or a rotating wheel, may be provided at the bottom of the sleeve, and the first traction wire 161 may be connected to the proximal end of the slider 146 after passing through the slider 146 and threading member 182. The second traction wire 162 is connected to the other slider 146, and the connection manner can be the same as that of the first traction wire 161, which is not described herein.
In this embodiment, the two sliding blocks 146 are independent from each other, the two sliding blocks 146 control the first traction wire 161 and the second traction wire 162 independently, when any sliding block 146 is moved axially, the sliding block 146 pulls and releases the corresponding traction wire to change the bending state of the sheath tube 13, and under the action of no external force, the sliding block 146 is static relative to the housing 11, i.e. under the action of no other external force, the sheath tube 13 can keep the original bending state, and the effects of stopping at any time and stopping when the hand is released when the bending is adjusted are achieved.
Example five
The fifth embodiment is the same as or similar to the third embodiment, and the main difference between them is that, as shown in fig. 30, the driving mechanism 14 of the fifth embodiment includes a slider 146, the stop member 18 is a sleeve, the sleeve is sleeved on the outer peripheral side of the slider 146, the slider 146 can axially move relative to the sleeve, and a slot (not shown) for sliding the slider 146 is formed on the housing 11.
Specifically, the inner wall of the sleeve is embedded with a silica gel ring 147, and the sliding block 146 is in interference fit with the sleeve through the silica gel ring 147. One of the first traction wire 161 and the second traction wire 162 is connected with the distal end of the sliding block 146, and a wire penetrating member 182, preferably a fixed ring or a rotating wheel, is arranged at the bottom of the sleeve barrel, and the other one of the first traction wire 161 and the second traction wire 162 is connected with the proximal end of the sliding block 146 after passing through the sliding block 146 and the wire penetrating member 182.
In this embodiment, when the slider 146 is moved axially, when any one of the first traction wire 161 and the second traction wire 162 is pulled, the other traction wire is released correspondingly, and then the sheath 13 is controlled to bend in both directions. And under the action of non-external force, the sliding block 146 is static relative to the shell 11, namely under the action of no other external force, the sheath 13 can be kept in the original bending state, and the effects of stopping at any time and stopping when the hand is released are achieved when bending is adjusted.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (16)

1. An adjustable bend catheter, characterized in that: the device comprises a sheath tube, a shell arranged at the proximal end of the sheath tube, a driving mechanism arranged in the shell, a stopping piece and at least one traction wire, wherein the distal end of the traction wire is connected with the distal end of the sheath tube, the proximal end of the traction wire stretches into the shell and is connected with the driving mechanism, the driving mechanism is used for pulling and releasing the traction wire to achieve bending of the sheath tube, the stopping piece is abutted with the driving mechanism and is in interference fit with the driving mechanism, so that the driving mechanism is static relative to the shell under the action of non-external force and moves relative to the shell under the action of external force, and the driving mechanism moves changes the bending state of the sheath tube in the process of pulling and releasing the traction wire.
2. The adjustable bend catheter of claim 1, wherein: the driving mechanism comprises a driving piece and a driven piece, the driving piece is connected with a driven piece bevel gear, the proximal end of the traction wire is connected with the driven piece, and the driving piece drives the driven piece to pull and release the traction wire.
3. The adjustable bend catheter of claim 2, wherein: the driving mechanism comprises at least one driven piece, and the driven pieces are in one-to-one correspondence with the traction wires;
the driving piece is a driving bevel gear, the driven piece is a driven bevel gear meshed with the driving bevel gear, the driven bevel gear is connected with a corresponding traction wire, and the driving bevel gear drives the driven bevel gear to pull and release the traction wire connected with the driven bevel gear.
4. A tunable bending catheter according to claim 3, wherein: the driven bevel gear comprises a gear part meshed with the drive bevel gear and a wire spool connected with the gear part, wherein the traction wire is wound on the wire spool, and the drive bevel gear drives the gear part to pull and release the traction wire wound on the wire spool.
5. The adjustable bend catheter of claim 4, wherein: the driven bevel gear further comprises a cover sleeve, the cover sleeve is arranged on the wire spool and surrounds the wire spool to form an independent space for the traction wire to wind, and an opening for the traction wire to penetrate is formed in the cover sleeve.
6. The adjustable bend catheter of claim 2, wherein: the driving mechanism further comprises an adjusting pipe, the distal end of the adjusting pipe is connected with the driving part, at least one limiting part is arranged on the adjusting pipe and protrudes out of the outer peripheral surface of the adjusting pipe, a silica gel gasket is sleeved on the limiting part, and the stopping part is in interference fit with the limiting part through the silica gel gasket.
7. The adjustable bend catheter of claim 6, wherein: the bendable catheter further comprises an adjusting component connected with the proximal end of the adjusting tube, the adjusting component is at least partially exposed out of the shell, and the adjusting component drives the adjusting tube to move relative to the shell.
8. The adjustable bend catheter of claim 7, wherein: the adjustable bend guide pipe further comprises a limiting mechanism, wherein the limiting mechanism comprises two limit stops and at least one limiting pin, one of the limit stops and the limiting pins is connected with the adjusting part and moves synchronously with the adjusting part, and the other limit stop and the limiting pin are kept static relative to the shell;
The two limit stops define a rotation space, and the limit pin moves relative to the limit stop in the rotation space.
9. The adjustable bend catheter of claim 1, wherein: the driving mechanism comprises at least one sliding block, the stop piece is sleeved on the outer peripheral side of the sliding block, the sliding block can move axially relative to the stop piece, a silica gel ring is embedded in the inner wall of the stop piece, and the sliding block is in interference fit with the stop piece through the silica gel ring.
10. The adjustable bend catheter according to any one of claims 1-9, wherein: the distal end fixedly connected with anchor ring of sheath, set up logical groove on the periphery lateral wall of anchor ring, be equipped with a baffle in the logical groove, draw the silk from one side of baffle is penetrated logical groove and follow the opposite side of baffle is worn out logical groove.
11. The adjustable bend catheter according to any one of claims 1-9, wherein: the distal end fixedly connected with anchor ring of sheath, offered through-hole and wire mouth on the lateral wall of anchor ring, draw the silk and pass behind the through-hole from the wire mouth of crossing.
12. The adjustable bend catheter according to any one of claims 1-9, wherein: the sheath includes a distal soft segment, a bendable segment, and a proximal hard segment, the bendable segment being located between the distal soft segment and the proximal hard segment.
13. The adjustable bend catheter of claim 12, wherein: the sheath tube is provided with a first developing ring and a second developing ring, the first developing ring is arranged at the distal end of the bendable section, and the second developing ring is arranged between the distal end of the proximal hard section and the proximal end of the bendable section.
14. The adjustable bend catheter of claim 13, wherein: the first notch and the second notch are respectively formed in two opposite sides of the first developing ring, and the first notch and the second notch are different in size and/or different in notch orientation.
15. The adjustable bend catheter of claim 12, wherein: the bendable section has a three-layer structure, wherein the inner layer is PTFE, the middle layer is a spring structure, and the outer layer is PEBAX;
and/or the distal soft segment has a double-layer structure, wherein the inner layer is PTFE, and the outer layer is PEBAX;
and/or the proximal hard segment has a three-layer structure, the inner layer is PTFE, the middle layer is a woven mesh structure, and the outer layer is PEBAX.
16. The adjustable bend catheter according to any one of claims 1-9, wherein: the bendable catheter further comprises a sheath core, wherein the proximal end of the sheath core is in threaded connection with the proximal end of the sheath tube and is accommodated in the sheath tube, and the distal end of the sheath core penetrates out of the sheath tube.
CN202111668167.1A 2021-12-30 2021-12-30 Adjustable curved conduit Pending CN116407741A (en)

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PCT/CN2022/137948 WO2023124904A1 (en) 2021-12-30 2022-12-09 Steerable catheter

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