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WO2013117138A1 - Canal de gainage qui peut être ajusté de manière à être cintré - Google Patents

Canal de gainage qui peut être ajusté de manière à être cintré Download PDF

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Publication number
WO2013117138A1
WO2013117138A1 PCT/CN2013/071106 CN2013071106W WO2013117138A1 WO 2013117138 A1 WO2013117138 A1 WO 2013117138A1 CN 2013071106 W CN2013071106 W CN 2013071106W WO 2013117138 A1 WO2013117138 A1 WO 2013117138A1
Authority
WO
WIPO (PCT)
Prior art keywords
drum
handle
branch
sheath tube
lock slider
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2013/071106
Other languages
English (en)
Chinese (zh)
Inventor
张庭超
付伟国
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
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 Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Publication of WO2013117138A1 publication Critical patent/WO2013117138A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers

Definitions

  • the invention relates to the technical field of medical sheath tubes, in particular to a distally adjustable curved sheath tube, which is used for minimally invasive interventional diagnosis and treatment of human body, establishes a channel, and introduces or exports a medical device, a medicine or a body fluid.
  • the sheath consists of a tube body and a handle.
  • the tube body is long and has a lumen for the passage.
  • the tube body has a distal end and a proximal end. The distal end can easily enter the human lumen (such as a blood vessel), and the proximal end can be used.
  • the distal end of the sheath is typically inserted into the blood vessel and then continues to be inserted into the body such that the distal end reaches a predetermined location (eg, a lesion) through which the drug, body fluid, or instrument passes.
  • a predetermined location eg, a lesion
  • the smaller the outer diameter of the tubular body the less trauma to the human lumen.
  • the operator typically needs to advance the distal end of the sheath to a predetermined position by external manipulation of the handle under the guidance of the X-ray machine.
  • a better sheath design should have both good guiding, torsional control, sufficient axial and radial support, and maximization of the ratio of inner diameter to outer diameter, ie, thinning.
  • the distal end of the sheath tube is pre-formed into different curved shapes according to the intended use of the sheath tube, so as to adapt to the anatomical shape of the specific lesion portion, and the sheath is facilitated.
  • the distal end is aimed at the lesion in the human body.
  • distally shaped pre-shaped interventional sheaths of various shapes and angles have been developed and put into clinical use. This requires the hospital warehouse to have all the shapes and specifications of the sheath, which undoubtedly increases the number and quantity of the hospital's stocking, and increases the cost of hospital use.
  • the sheath usually needs the help of the guide wire and the dilator to reach the lesion accurately.
  • the guide wire can easily enter the lesion due to its soft characteristics; the pre-formed dilator is inserted into the lumen of the tube.
  • the distal end of the sheath will not retain the original pre-formed shape, leaving the distal end of the sheath offset from the target position.
  • the sheath will first give the guidewire a torsion, and the sheath will have a rebound force after the guidewire is withdrawn. Both of these forces will cause damage to the tissue surrounding the target site.
  • the distal end of the sheath can be adjusted, and the distal end of the sheath can be repeatedly changed between different angles by external adjustment to adapt to different physiological and anatomical forms.
  • the handle of the adjustable curved sheath tube of the prior art has different characteristics.
  • the adjustable curved sheath tube described in the document US Pat. No. 6,945,956 has a Y-shaped bifurcated handle, as shown in Fig. 1, wherein the adjustable curved sheath tube has a Y-shaped bifurcated handle, the handle comprising a main branch 82 and side branches 79, and a pulling wire 78 is pierced from the proximal side wall of the tubular body 77, and the proximal end of the pulling wire 78 passes through the handle side branch 79 and is connected to the lock slider 80, and the pulling slider 78 can be pulled or loosened by the lock slider 80.
  • the curved shape of the distal end elastic section 76 of the sheath is changed, but the lock slider 80 must be controlled directly by hand. Since the handle cannot enter the human body, the length of the tube body 77 inserted into the handle must be left outside the human body, so the instrument introduced into the human body from the tube body 77 must also be extended by the corresponding length.
  • the main branch 82 of the bifurcated handle does not need to provide a grip position, thus shortening the length of the tube 77 inserted into the handle (as short as about 2 cm), which is advantageous for matching shorter instruments.
  • the adjustable curved sheath tube described in the document US Pat. No. 7,678,074 has a straight handle, as shown in Fig. 2, wherein the adjustable curved sheath tube has a straight handle, and the pulling wire 55 is led out from the proximal side wall of the tubular body 51 and It is fixed to a slidable lock control device which includes a trigger 52, a fixed block 57, a lower block 59 and a spring 58 which engages with a rack 56 on the handle.
  • the trigger 52 is pushed to push the lower block 59 away from the rack 56.
  • the trigger 52 can be slid back and forth, and the entire locking device can be moved along the axial direction of the tube 51 to pull or loosen the pulling wire 55 and realize the turning.
  • the elastic piece 58 causes the lower tooth piece 59 to bounce, the lower tooth piece 59 engages with the rack 56 of the handle, and the locking device is fixed at a predetermined position of the handle, thereby locking the angle of the distal end of the sheath tube, which is convenient.
  • the doctor performs other surgical operations.
  • the adjustable curved sheath tubes of the prior art are all realized by the operation of the handle to achieve a change in the bending angle of the distal end. Most of the length of the tube needs to be inserted into the human blood vessel or other pipelines to reach the predetermined position. The operator must monitor the shape and position of the body body by X-ray fluoroscopy to ensure safety and effect if the adjustable sheath is Inconvenient or inaccurate operation can prolong the exposure of the patient to X-rays and increase the risk to the patient and the operator.
  • the above-mentioned prior art adjustable curved sheath tube has the following drawbacks:
  • the handle of the adjustable curved sheath tube of document US Pat. No. 6,945,956 lacks position identification and self-locking means, and the operator must adjust the change of the distal end angle of the tube body under X-ray while adjusting the handle so that the distal end of the tube body is directed to the target position, and
  • the pulling force of the traction wire must be kept constant to maintain the adjustment angle of the distal end of the sheath.
  • the pulling force of the pulling wire is generally as high as 40N, and it is difficult to control smoothly by hand dragging directly, which affects the precise positioning of the distal end of the sheath. Since the handle can neither accurately adjust the angle nor lock the angle, and the pulling force of the pulling wire changes slightly, the turning angle will change relatively. The operator needs to always use the force to keep the angle unchanged, and import or export other instruments or drugs. Very inconvenient, it is bound to extend the X-ray irradiation time.
  • the straight handle length must be relatively long (at least 10 cm) in order to be suitable for stable hand holding and sufficient remaining The length is used to install easy-to-operate buttons and slide locks, while the long straight handles are not good for matching shorter instruments.
  • the bending angle of the distal end of the tube body cannot be continuously adjusted, and moving from one tooth to the adjacent tooth will cause a jump change in the bending angle of the distal end of the tube body. It is not easy to operate.
  • the pulling force of the pulling wire is generally as high as 40N.
  • the button When the button is pressed with the finger, the button is moved to pull the pulling wire. This multi-directional operation is also difficult to control smoothly, which affects the precise positioning of the distal end of the sheath.
  • an axial torsion handle is required due to the curved circuit that bends and may require the distal end of the tube to bend in different directions during travel or after reaching the lesion.
  • the button position of the handle can indicate the angle of curvature of the distal end of the sheath
  • the button is located on one side of the handle. Once the handle is turned to the side obstructing the operator's line of sight, it is inconvenient to judge the distal end bending angle of the sheath by observing the handle. It is judged by turning on X-ray fluoroscopy, and the operator's finger is also not convenient to control the distance the button moves.
  • the prior art adopts the adjustable curved sheath tube of the lever type handle, which reduces the tension of the hand and contributes to the stability of the operation, but it is difficult to accurately control the angle of the distal end of the tube body, and can not be judged by observing the handle.
  • the bending angle of the distal end of the sheath will prolong the X-ray exposure time.
  • the adjustable bending sheath tube in the prior art has uneven force in adjusting the angle, and the continuity and accuracy are not good; the bending operation is inconvenient, which is not conducive to observing and calibrating the adjusting part of the handle;
  • the straight handles are too long to be used to transport shorter instruments.
  • the main object of the present invention is to provide a distally adjustable curved sheath tube, which can improve the precision of the bending angle control of the distal end of the sheath tube under the premise of ensuring that the handle has a minimum effective length, so that the operation process is convenient and easy to control, Improve the safety of surgery.
  • the present invention provides an adjustable curved sheath tube comprising a tubular body, a pulling wire and a handle, the pulling wire being slidable within the tubular body and the handle, the tubular body having a proximal end and a distal end, the proximal end of the tubular body is coupled to the handle, the handle includes a branch, the branch is located on a side near the proximal end of the tubular body, and the branch is provided with a translation along the branch a movable part, the proximal end of the traction wire is fixed on the movable part, the distal end of the traction wire is fixed to the distal end of the tubular body; the distal end of the tubular body has an elastic section, The bending angle of the elastic segment is changed when the movable member is translated on the branch, and the movable member is screwed with the branch.
  • the movable member maintains a self-locking state when no external force acts; and releases the self-locking state when moved by an external force.
  • the movable component is a locking slider, and the locking slider has teeth on one side or both sides;
  • the branch includes a side pillar and a rotating sleeve that is sleeved on the side pillar and is freely rotatable
  • the side pillar is provided with a guiding groove along an axis thereof, and the locking slider is disposed in the rotating cylinder and the guiding groove, and is translatable along the guiding groove; the inner wall of the rotating cylinder A helical tooth groove matching the teeth of the lock slider is provided.
  • the guiding groove has a pair of flat side walls
  • the locking slider has a pair of flat sides
  • a pair of side walls of the guiding groove are respectively balanced with a pair of the locking sliders In side contact, the lock slider can slide within the guide groove.
  • At least a portion of the spinner is made of a transparent material.
  • the root of the side pillar is provided with a limiting device, and the inner diameter of the rotating cylinder is smaller than the maximum diameter of the limiting device.
  • the movable part is a moving drum
  • the inner wall of the moving drum is provided with a thread
  • the moving drum has a tail
  • the branch of the handle is a screw
  • the screw and the moving drum The thread is matched, the moving drum is sleeved on the screw;
  • the screw is provided with a wire cavity, and the proximal end of the wire passes through the wire cavity and is fixed to the tail of the moving drum.
  • the center of the tail of the moving drum is provided with a freely rotatable pin, and the proximal end of the pulling wire is fixed to the pin.
  • the movable component is a lock slider and the branch comprises a freely rotatable drum
  • the drum is provided with a scale for indicating the position of the lock slider
  • the component is a moving drum and the branch is a screw, and the screw is provided with a scale for indicating the position of the moving drum.
  • the movable part is a lock slider and the branch comprises a freely rotatable drum
  • the inner wall diameter D of the drum and the pitch d of the thread thereon satisfy the relationship d ⁇ D, wherein ⁇ a maximum static coefficient of friction of the contact surface between the lock slider and the spinner
  • the movable member is a moving drum and the branch is a screw
  • the inner wall diameter D of the moving drum and the The pitch d of the upper thread satisfies the relationship d ⁇ ⁇ ⁇ D, where ⁇ is the maximum static friction coefficient of the contact surface between the screw and the moving drum.
  • the invention provides an adjustable curved sheath tube.
  • the operating handle of the sheath tube adopts a bifurcated structure, which can shorten the length of the handle to the maximum extent, and ensures the adaptability of the adjustable curved sheath tube to other instruments, and can be transported more.
  • the handle is provided with movable parts for adjusting the bending angle of the distal end of the sheath, utilizing the inclined static friction Principle, the moving parts are connected with the traction wire, which converts the short-distance linear motion of the traction wire into a continuous large-angle rotation with easy control, and the thread engagement between the movable part and other parts of the handle realizes the self-locking function, and automatically locks the pipe body at any time.
  • the bending angle of the end even if the pulling force of the pulling wire is very large, gently rotate the knob on the handle to unlock, and can freely switch between the locked and unlocked states without any additional operation, and will not be forced by force.
  • the invention further adopts a transparent material to make the knob of the handle, uses the color striking material to make the lock slider of the handle, and can mark the omnidirectional on the outer surface of the drum A visible scale indicating the distance the lock slider moves, to facilitate determining the relative magnitude of the bending angle of the distal elastic section of the tubular body, even if the X-ray is not turned on, regardless of the angle at which the coil on the handle is rotated, The operator can easily observe the distance the lock slider moves to infer the approximate bending angle of the elastic section of the sheath distal end, reducing the exposure time of the patient and the doctor in X-rays, and reducing the hazard.
  • the adjustable curved sheath tube of the invention can shorten the effective length of the handle, improve the precision of the angle control, and make the operation process convenient and easy to control.
  • FIG. 1 is a schematic view of an adjustable curved sheath tube in the prior art
  • FIG. 2 is a cross-sectional structural view of a straight handle of another adjustable curved sheath tube in the prior art
  • FIG. 3 is a schematic view showing a pipe body of an adjustable curved sheath tube according to a first embodiment of the present invention
  • Figure 4 is a schematic view of the distal end of the tubular body shown in Figure 3 when bent;
  • Figure 5 is a schematic view of a bendable sheath tube according to a first embodiment of the present invention.
  • Figure 6 is a schematic view of the distal end of the adjustable curved sheath tube shown in Figure 5 after bending;
  • Figure 7 is an assembled and exploded schematic view of the adjustable curved sheath tube shown in Figure 5;
  • Figure 8 is a schematic view showing the structure of the handle of the adjustable curved sheath tube shown in Figure 5;
  • Figure 9 is a cross-sectional view of the side pillar of the handle shown in Figure 8.
  • Figure 10 is a cross-sectional view of the Y-joint of the handle shown in Figure 8;
  • Figure 11 is a schematic view showing the assembly of the Y-shaped joint and the lock control slider of the handle shown in Figure 8;
  • Figure 12 is a schematic view of the handle scale when the adjustable curved sheath tube shown in Figure 5 is in an initial state
  • Figure 13 is a schematic view of the handle scale when the distal end angle of the adjustable curved sheath tube shown in Figure 5 reaches 60°;
  • Figure 14 is a schematic view of the handle scale when the distal end of the adjustable curved sheath tube shown in Figure 5 is bent into a U shape;
  • Figure 15 is a schematic view of a bendable sheath tube according to a second embodiment of the present invention.
  • Figure 16 is a cross-sectional view showing the handle of the adjustable curved sheath tube shown in Figure 15 in an initial state;
  • Figure 17 is a cross-sectional view showing the handle of the adjustable curved sheath tube shown in Figure 15 in a state of being turned.
  • the solution of the embodiment of the invention is mainly: the handle of the adjustable curved sheath tube adopts a bifurcated structure, and a movable component having a thread connection with the branch is arranged on the branch of the handle, which can shorten the effective length of the handle to the utmost extent (along The longitudinal length of the pipe body) can improve the accuracy of the bending angle control of the sheath distal end, and the operation process is convenient and easy to control through the self-locking function.
  • the invention provides an adjustable curved sheath tube comprising a tube body, a pulling wire and a handle, the tube body having a proximal end and a distal end, the proximal end of the tube body being connected with the handle, the handle comprising a branch, the branch being located in the tube body
  • the tube body is provided with a filament cavity for threading the traction wire
  • the branch is provided with a movable part that can be translated along the branch, the proximal end of the traction wire is fixed on the movable part, and the distal end of the traction wire is fixed to the tube.
  • the distal end of the body; the distal end of the tubular body has an elastic section, and the bending angle of the elastic section can be changed when the movable part is translated on the branch, wherein the movable part and the branch are connected by screwing.
  • the movable component maintains a self-locking state when it is not subjected to an external force; when it is moved by an external force, the self-locking state can be released.
  • FIG. 1 to FIG. 14 is an adjustable curved sheath tube according to a first embodiment of the present invention.
  • the movable component in this embodiment is a lock control slider 18 , which is in this embodiment.
  • the adjustable curved sheath tube includes a tubular body 1, a pulling wire 4 and a handle 8.
  • the pipe body 1 is mainly made of a polymer material, and the manufacturing method and size requirements thereof have been known in the prior art, and will not be described herein.
  • the tubular body 1 is a long straight tube.
  • the distal end 2 of the tubular body adjacent to the tubular body 1 has an elastic section 5 which is freely bendable and actively restored to its original shape within a certain arc range.
  • Between the elastic section 5 and the proximal end 3 of the tubular body is a longer and stiffer hard section 7.
  • the distal end 2 of the tubular body is provided with a head 6 having a smooth profile to reduce damage to the human lumen by the distal end 2 of the tubular body.
  • the tubular body 1 comprises at least one delivery lumen and at least one traction wire lumen. The delivery lumen extends continuously from the distal end 2 of the tubular body to the proximal end 3 of the tubular body.
  • the traction wire 4 passes through the traction wire lumen and is embedded in the middle of the tube wall of the tubular body 1, at least one anchor 31 is buried in the wall of the tube near the head 6, and the distal end of the traction wire 4 is fixed on the anchor 31
  • the proximal end of the traction wire 4 is led out from the side wall near the proximal end 3 of the tubular body.
  • the pulling wire 4 is strongly tensioned near the proximal end 3 of the tubular body to realize the function of bending the elastic segment 5 within a certain angle range, as shown in FIG. If the pulling force on the pulling wire 4 is removed, the elastic segment 5 will return to the straight shape shown in Fig. 3 under the action of the elasticity of the plastic itself.
  • the handle 8 includes a Y-joint 9, a spinner 12, an end cap 14 and a T-joint 10, as shown in FIG.
  • the T-joint 10 is connected to the hose 15 and the three-way valve 16, and a ring cover 11 is disposed at the proximal end of the T-joint 10, and the three-way valve 16 can be connected to the tube body 1 by a syringe or other instrument. Inject liquid into the lumen or extract body fluid.
  • the steering cylinder 12 can drive the pulling wire 4 and change the angle of the elastic section 5 as shown in FIG.
  • the Y-joint 9 has a lumen of 1 to 2 cm long for mounting the tubular body 1, and a side pillar 24 having a length of about 5 to 10 cm and a diameter of about 0.5 to 1 cm extending from one side of the Y-joint 9 and a Y-joint
  • the axis of the lumen of 9 has an angle of between 10 and 70 between the axis of the side struts 24.
  • a guide groove 22 having a width of about 0.2 to 0.5 cm is disposed along the axis of the side post 24, and preferably the length of the guide groove 22 is 30% to 90% of the length of the side post 24, and the guide groove 22 preferably penetrates the side post 24.
  • a narrow frame shape is formed on opposite sides.
  • a lock slider 18 is placed in the 22 channel and is translatable along the channel 22.
  • the lumen, side struts 24 and channels 22 of the Y-joint 9 can be injection molded at one time, as shown in FIG.
  • the branch of the handle 8 of the present embodiment is mainly composed of the side pillar 24 and the rotating sleeve 12 sleeved on the side pillar 24, and the rotating cylinder 12 and the locking slider 18 are screwed.
  • the drum 12 is a cylinder that is slightly longer or equal in length than the guide groove 22, which can be freely rotated over the side struts 24 and closes the guide groove 22.
  • An end cap 14 is secured to the end of the side strut 24 to prevent the spinner 12 from disengaging from the side strut 24, but does not interfere with the free rotation of the spinner 12.
  • One end of the pulling wire 4 buried in the pipe body 1 is passed through the side wall of the pipe body 1, and is connected to the lock slider 18. As shown in FIG. 9, the lock slider 18 is mounted in the guide groove 22, and the surface of the lock slider 18 has teeth 25.
  • the inner wall of the rotating cylinder 12 is provided with a spiral tooth groove 26 matching the teeth 25 of the locking slider 18, and the locking slider 18 is driven by the rotating rotating cylinder 12 to perform linear reciprocating motion, pulling and locking the slider
  • the 18 connected traction wires 4 change the bending angle of the elastic section 5 of the tubular body 1.
  • the drum 12 is made of a transparent material, such as transparent plastic such as PC, PS, PET, etc., and the side pillars 24 can be seen through the drum 12, and the swirling can be seen through the drum 12 from different directions.
  • a scale 17 (such as a dot, line or other symbol) may be formed on the side surface of the transparent spinner 12 for use in indicating the position of the lock slider 18 in the guide groove 22 by dyeing, injection molding or machining. In order to observe the scales 17 from different directions, each of the scales 17 is preferably circumferentially distributed on the side surface of the drum 12.
  • the lock slider 18 is moved by a scale 17, and the drum 12 is just rotated one turn, making the operation more convenient.
  • the pitch is an integral multiple of the pitch of the scale 17, and the distance by which the lock slider 18 moves can be observed more accurately.
  • the lock slider 18 can be made of metal (such as stainless steel) or a polymer material.
  • the color of the lock slider 18 is different from the color of the side pillars 24.
  • the side struts 24 are made of a light color (such as white or light blue) material; the lock sliders 18 are made of a darker color (such as red, black or dark blue), preferably with a higher hardness.
  • Plastics (POM, PA, ABS, etc.) are formed by machining or injection molding.
  • the T-joint 10 is about 1 to 2 cm long and has a longitudinal lumen for the butt joint 1.
  • the inner side wall of the T-joint 10 is laterally connected to the hose 15 and the longitudinal cavity forms a three-way connection with the hose 15.
  • the tube 1, Y-joint 9 and T-joint 10 of Figure 7 can be assembled together by expanding the proximal end 3 of the tubular body into a flare 19 and passing the distal end 2 of the tubular body through a Y-joint.
  • the proximal end of the lumen of the Y-joint 9 is placed around the bell mouth 19, and then the distal end of the T-joint 10 is pressed into the proximal end of the lumen of the Y-joint 9, the distal end of the T-joint 10
  • the tapered surface 20 presses the inner surface of the bell mouth 19 to generate a pressing force to fix the pipe body 1 to the Y-shaped joint 9, so that the conveying cavity of the pipe body 1 abuts and communicates with the inner cavity of the T-joint 10, and at the same time It acts to seal against side leakage.
  • the inner diameter of the T-joint 10 is preferably the same as the diameter of the delivery lumen of the tubular body 1 to facilitate the passage of the instrument or drug.
  • a ring-shaped cover 11 with a hole in the middle is fixed to the proximal end of the T-joint 10.
  • the ring cover 11 and the T-joint 10 are connected by a buckle or a screw, and the silicone gasket 21 is clamped therebetween.
  • the silicone gasket 21 seals only the proximal end of the lumen of the T-junction 10.
  • the silicone gasket 21 has a crack in the middle but is normally kept closed, and a dilator or other instrument that cooperates with the adjustable curved sheath tube can pass through the crack of the ring cover 11 and the silicone gasket 21 into the delivery lumen of the tubular body 1.
  • a dilator or other instrument that cooperates with the adjustable curved sheath tube can pass through the crack of the ring cover 11 and the silicone gasket 21 into the delivery lumen of the tubular body 1.
  • the silicone gasket 21 can return to the original closed state due to its elasticity to function as a seal.
  • Figure 8 is a partial cross-sectional view of the Y-joint 9, wherein the root of the side strut 24 has a wire hole 29 substantially along the axial direction of the side strut 24, and the lumen of the Y-joint 9 communicates with one end of the wire hole 29, the wire hole The other end of the 29 is led to the guide groove 22, and the pulling wire 4 passing through the side wall of the pipe body 1 can enter the guide groove 22 through the wire hole 29 and be fixed to the lock slider 18.
  • the pipe body 1 is inserted into the lumen of the Y-joint 9, and the pulling wire 4 is passed through the wire hole 29.
  • FIG. 9 A partial longitudinal section of the side struts 24 and the spinner 12 is shown in FIG. 9 with a section along the central axis of the side struts 24 and through the entire guide channel 22.
  • the side struts 24 are substantially the side walls of the channel 22, and the lock sliders 18 are located within the drum 12 and the channel 22.
  • Fixing holes 23, teeth 25 and pins 28 are respectively provided on different sides of the lock slider 18.
  • the pulling wire 4 is inserted into the fixing hole 23 and brought into contact with the pin 28, and one end of the pulling wire 4 is fixed to the lock slider 18 by the pin 28.
  • the pin 28 can be secured in a manner that is threaded or its equivalent, capable of withstanding the maximum pulling force of the pulling wire 4.
  • the fixing holes 23 are preferably opposed to the wire holes 29 to facilitate the insertion of the pulling wires 4, and the pins 28 are preferably perpendicular to the fixing holes 23 to facilitate the fixing of the pulling wires 4.
  • the inner wall of the rotating cylinder 12 has a spiral tooth groove 26, and the tooth 25 is matched with the tooth groove 26.
  • the rotating rotating wheel 12 can drive the locking slider 18 to perform linear reciprocating motion, and the locking slider 18 pulls and pulls.
  • the wire 4 thus changes the bending angle of the elastic section 5.
  • the lock slider 18 is preferably a rectangular parallelepiped having a pair of parallel sides respectively contacting the side walls of the guide groove 22, and the other pair of parallel sides are respectively provided with teeth 25, so that the lock slider 18 can follow the guide groove The direction of the track, which is restricted by the 22 and the spinner 12, smoothly slides and cannot rotate.
  • the guide groove 22 may also be open only on one side, and at this time, the bottom of the guide groove 22 is in smooth contact with the bottom (no teeth) of the lock slider 18, and only the tooth is provided on the top (one side) of the lock slider 18. 25 and matching the gullet 26, however, the aforementioned two-sidedly disposed teeth 25 are balanced by force to facilitate smooth movement of the lock slider 18.
  • a limiting device may be disposed at the root of the side pillar 24, and the limiting device may be a limiting plate 27.
  • the inner diameter of the rotating cylinder 12 is smaller than the maximum diameter of the limiting plate 27.
  • the initial shape of the tubular body 1 is generally natural straight.
  • the pulling wire 4 cannot be loosened and only has a weak pulling force.
  • the bending of the elastic segment 5 near the distal end 2 of the tubular body is changed. This can be achieved by the pin 28 and the mounting holes 30 in the side struts 24.
  • the pin 28 can be just installed through the fitting hole 30 to appropriately set the initial state of the pulling wire 4, such as the Y-shaped joint of FIG.
  • the cross section of Fig. 9 is as shown in Fig. 11 as seen from the front of the fitting hole 30.
  • the lock slider 18 When the traction wire 4 is fixed, the lock slider 18 should be closest to the limit plate 27, and then the traction wire 4 is inserted into the fixing hole 23, while pulling the traction wire 4 with a little force while maintaining the natural straight state of the pipe body 1, one side A small tool (such as a screwdriver) is used to pass the fitting hole 30 to mount the pin 28 and fix the pulling wire 4, at which time the pulling force of the pulling wire 4 is minimized.
  • a small tool such as a screwdriver
  • the tooth groove 26 extends continuously to both ends of the rotating drum 12, the guiding groove 22 extends to the position of the limiting plate 27, and the installed locking slider 18 is also attached to the limiting plate 27, and the side pillar 24 can be directly Inserted into the spinner 12, the teeth 25 of the lock slider 18 are directly inserted into the entrance of the slot 26.
  • the lock slider 18 does not contact the slot 26, and thus does not hinder the movement of the opposite side leg 24 of the drum 12, as shown in Fig. 12.
  • the two ends of the cylinder 12 are respectively restrained by the limiting plate 27 and the end cover 14, and the tooth groove 26 rotates with the rotating drum 12 but cannot translate in the axial direction of the rotating drum 12, that is, the teeth 25 are translated along the axis of the rotating drum 12
  • the tooth groove 26 rotates about the axis of the drum 12, and the tooth 25 is spirally slid with respect to the tooth groove 26.
  • the diameter D of the inner wall of the drum 12 and the pitch d of the tooth groove 26 determine the rotation angle of the tooth groove 26 (and the drum 12).
  • Each of the scales 17 on the drum 12 corresponds to a position of the lock slider 18, so that the scale 17 forms a certain correspondence with the bending angle of the elastic section 5 near the distal end 2 of the tubular body, thereby passing through the drum 12
  • the scale 17 can roughly determine the turning angle of the elastic section 5 near the distal end 2 of the tubular body.
  • the lock slider 18 is located at the origin of the scale 17, and a slight tension is generated in the traction wire 4.
  • the preferred range of the pitch d is 0.5 to 5 mm. If the pipe body 1 is long or its inner diameter is large, or the angle of variation of the elastic segment 5 is large, a relatively large pitch d can be selected, so that the drum 12 does not need to rotate too many turns, and then Select the appropriate inner diameter D of the drum to meet the static friction requirements. If the pipe body 1 is short or its inner diameter is small, or the elastic segment 5 has a small variation range, the relatively small pitch d and the inner diameter D of the drum can be selected to improve the controllable precision of the corner. It is more convenient to judge the turning angle of the elastic section 5 by the number of turns rotated by the drum 12.
  • the pitch d is selected to be 2 mm
  • the initial value of the lock slider 18 relative to the scale 17 is moved by about 6 mm
  • the rotary cylinder 12 is The initial position is rotated about three turns, and the distal end 2 of the tubular body is deflected by 60° with respect to the tubular body 1, as shown in FIG.
  • the lock slider 18 is moved by about 10 mm with respect to the initial value of the scale 17, and the drum 12 is rotated about five times from the initial position, the angle between the distal end 2 of the tubular body and the tubular body 1 becomes 0°, that is, the angle When the angle is changed by 180°, the elastic section 5 is bent into a U shape as shown in FIG. In this way, the operator can be given a clear indication, which facilitates the operation and reduces the X-ray radiation hazard.
  • the distal end 2 of the tubular body is positioned near the target area in the human body, the operator rotates the spinner 12 and observes the number of revolutions or the scale 17 corresponding to the lock slider 18, and does not need to open the tube of the X-ray perspective body.
  • the distal end 2 of the tubular body can be adjusted to a position previously aligned with X-rays.
  • the operating handle 8 of the adjustable curved sheath tube adopts a bifurcated structure, which can shorten the effective length of the handle 8 to the utmost extent, and ensures the adaptability of the adjustable curved sheath tube to other instruments.
  • the handle is more suitable for transporting some shorter other instruments, and is more suitable for gripping operation than the prior art bifurcated handle, and is ergonomic;
  • the handle 8 is provided with a bending angle for adjusting the elastic section 5.
  • the lock slider 18 and the rotary cylinder 12 convert the short-distance linear motion of the traction wire 4 into a continuous large-angle rotation that is easy to control by any finger, which not only can significantly reduce the manual operation force, but also has a self-locking function of angle adjustment.
  • the locking slider 18 is connected to the pulling wire 4 by using the principle of the inclined static friction.
  • the threaded engagement between the locking slider 18 and the rotating barrel 12 realizes the self-locking function, and automatically locks the bending angle of the elastic segment 5 at any time. Even if the pulling force of the pulling wire 4 is large, the rotating wheel 12 can be gently rotated to unlock, and no additional operation is required to freely switch between the locked and unlocked states, without being excessively forced.
  • the body 1 is shaken or the bending angle of the elastic segment 5 is abruptly changed, and the bending angle of the adjusted or locked elastic segment 5 can be continuously and smoothly changed, so that the operator can carry out the operation of transporting other instruments or drugs, thereby improving the convenience and accuracy of the operation;
  • the embodiment further uses the transparent material to make the knob 12 of the handle 8, and uses the color striking material to make the lock slider 18 of the handle 8, and can mark the omnidirectional visible scale 17 on the outer surface of the drum 12 to The distance indicating the movement of the lock slider 18 is used to conveniently determine the relative magnitude of the bending angle of the elastic segment 5. Even if the X-ray is not turned on, the operator can easily observe the lock slider 18 regardless of which direction the handle 8 is twisted. The distance moved to infer the approximate bending angle of the elastic segment 5, reducing the exposure time of the patient and the doctor in X-rays, and reducing the hazard.
  • an adjustable curved sheath tube according to a second embodiment of the present invention
  • the movable member in this embodiment is a moving rotary cylinder 35
  • the moving rotary cylinder 35 has a tail portion.
  • the main component of the branch of the middle handle 8 is a screw 37.
  • This embodiment is basically similar to the above-described first embodiment, and the main difference is the structure of the handle 8.
  • one side of the Y-joint 34 is a screw 37, and a thread is provided on the inner wall of the moving drum 35 to fit over the screw 37.
  • a wire cavity 32 is disposed along the axis of the screw 37, and the proximal end of the pulling wire 4 passes through the wire cavity 32 and is fixed to the bottom of the moving rotating drum 35.
  • a longitudinal section of the moving drum 35 and the screw 37 at the starting position is as shown in FIG.
  • the tail portion of the moving drum 35 has a bottom surface, and a freely rotatable pin 33 is disposed at the center of the bottom surface, and the proximal end of the pulling wire 4 is fixed on the pin 33, which is not only convenient for assembly, but when the rotating drum 35 is moved Rotating and the proximal end of the pulling wire 4 and the pin 33 are not rotated, and the pulling wire 4 can be prevented from being twisted by being twisted under a large tension.
  • a small portion of the thread on the side of the screw 37 is removed to form a flat and elongated scale plane 36 as shown in Figure 16, and a series of scales 17 are indicated from the stop plate 27 in the axial direction for indicating the movement of the knob 35.
  • the top position Preferably, a small portion of the thread on the side of the screw 37 is removed to form a flat and elongated scale plane 36 as shown in Figure 16, and a series of scales 17 are indicated from the stop plate 27 in the axial direction for indicating the movement of the knob 35. The top position.
  • a plurality of identical scale planes 36 can be provided at the axisymmetric position of the screw 37 so that the scales 17 are seen from different directions without affecting the stable fit of the moving drum 35 with the screw 37.
  • the pulling wire 4 needs to be pulled hard, that is, the moving drum 35 is away from the limit plate 27, and the exposed scale 17 can show the top position of the moving drum 35 and can be used for speculation.
  • the angle of the tube 1 is such that the moving drum 35 does not have to be made of a transparent material, as shown in FIG.
  • the principle and design requirements of the teeth 25 of the lock slider 18 in the foregoing first embodiment are also applicable to the teeth 25 on the screw 37.
  • the self-locking of the moving drum 35 is achieved, and the corner of the pipe body 1 is kept unchanged, and then rotated a little and then released. Lock status.
  • the moving drum 35 is rotated, due to the elastic restoring force of the pipe body 1, the pulling wire 4 is also retracted, and the adjustable bending sheath pipe will automatically return straight.
  • the adjustable curved sheath tube of the embodiment of the invention simultaneously achieves various technical effects: shortening the effective length of the handle 8, improving the accuracy of the angle control, and making the operation process convenient and easy to control. details as follows,
  • the longitudinal portion of the Y-shaped handle 8 can be short relative to the straight handle, so the adjustable curved sheath of the present invention
  • the auxiliary device that can be transported by the tube can have a larger length range
  • the handle 8 utilizes the principle of inclined static friction, the movable part is connected with the pulling wire 4, and the threaded engagement between the movable part and the other parts on the handle 8 realizes a self-locking function, and automatically locks the vicinity of the distal end 2 of the tube at any time.
  • the conversion does not cause the tube 1 to shake or the bending angle of the elastic section 5 to be abrupt due to excessive force, and the angle of adjustment or locking can be continuously and smoothly changed, so that the operator can carry out the operation of transporting other instruments or drugs, and improve the operation. Convenience and precision;
  • a scale 17 is provided on the branch of the handle 8, and even if the orientation of the handle 8 is twisted, the actual position and the moving distance of the movable member can be easily observed from different directions to estimate the distal end of the tubular body when the X-ray is temporarily turned off.
  • the bending angle of the nearby elastic section 5 reduces the exposure time of the patient and the doctor in the X-ray and reduces the hazard.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
PCT/CN2013/071106 2012-02-10 2013-01-30 Canal de gainage qui peut être ajusté de manière à être cintré Ceased WO2013117138A1 (fr)

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US20170079630A1 (en) * 2015-09-22 2017-03-23 Lifetech Scientific (Shenzhen) Co., Ltd. Steerable Sheath Tube and Method for Occluding Atrial Septal Defect
EP3226952A1 (fr) * 2014-12-01 2017-10-11 Koninklijke Philips N.V. Cathéter orientable pré-incurvé avec des fils de traction pour le contrôle d'une déflexion articulée
CN107952160A (zh) * 2017-11-23 2018-04-24 上海慧达医疗器械有限公司 导引导丝塑形器
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EP3226952A1 (fr) * 2014-12-01 2017-10-11 Koninklijke Philips N.V. Cathéter orientable pré-incurvé avec des fils de traction pour le contrôle d'une déflexion articulée
JP2016171893A (ja) * 2015-03-17 2016-09-29 日本ライフライン株式会社 医療機器用ハンドルおよび医療機器
WO2016147465A1 (fr) * 2015-03-17 2016-09-22 日本ライフライン株式会社 Poignée pour dispositif médical, et dispositif médical
US10779807B2 (en) * 2015-09-22 2020-09-22 Lifetech Scientific (Shenzhen) Co. Ltd. Steerable sheath tube and method for occluding atrial septal defect
US20170079630A1 (en) * 2015-09-22 2017-03-23 Lifetech Scientific (Shenzhen) Co., Ltd. Steerable Sheath Tube and Method for Occluding Atrial Septal Defect
CN107952160A (zh) * 2017-11-23 2018-04-24 上海慧达医疗器械有限公司 导引导丝塑形器
CN110074830A (zh) * 2019-05-08 2019-08-02 杭州堃博生物科技有限公司 可调弯鞘管调节手柄及可调弯鞘管系统
CN110101358A (zh) * 2019-05-08 2019-08-09 杭州堃博生物科技有限公司 可调弯鞘管系统
CN110215593A (zh) * 2019-07-20 2019-09-10 康沣生物科技(上海)有限公司 一种可调弯鞘管的拉线固定装置
CN111657836A (zh) * 2020-07-23 2020-09-15 贾民勇 手持分体一次性支气管镜
CN112220504A (zh) * 2020-09-23 2021-01-15 山前（珠海）医疗科技有限公司 一种可操纵鞘管
CN118750729A (zh) * 2020-10-30 2024-10-11 杭州德晋医疗科技有限公司 可调弯鞘
CN112244961A (zh) * 2020-11-09 2021-01-22 北京华脉泰科医疗器械有限公司 鞘管调节机构及可调弯鞘管
CN112244961B (zh) * 2020-11-09 2024-06-07 北京华脉泰科医疗器械股份有限公司 鞘管调节机构及可调弯鞘管
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CN113456986B (zh) * 2021-05-30 2023-04-28 为泰医疗器械(深圳)有限公司 一种冠状动脉介入术用双腔微导管
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CN116650805A (zh) * 2023-04-24 2023-08-29 昌明生物科技（苏州）有限公司 一种调弯导管鞘装置及其调弯方法
LU506148A1 (en) * 2024-01-17 2024-07-17 The Second Affiliated Hospital Of Wenzhou Medical Univ An adjustable and bendable guiding sheath
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