WO2015096740A1 - 可调弯鞘管 - Google Patents

可调弯鞘管 Download PDF

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Publication number
WO2015096740A1
WO2015096740A1 PCT/CN2014/094826 CN2014094826W WO2015096740A1 WO 2015096740 A1 WO2015096740 A1 WO 2015096740A1 CN 2014094826 W CN2014094826 W CN 2014094826W WO 2015096740 A1 WO2015096740 A1 WO 2015096740A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchoring ring
traction
sheath tube
section
tubular body
Prior art date
Application number
PCT/CN2014/094826
Other languages
English (en)
French (fr)
Inventor
张庭超
李阳
王刚
张德元
符伟国
Original Assignee
先健科技(深圳)有限公司
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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to US15/107,836 priority Critical patent/US10188834B2/en
Priority to EP14874604.3A priority patent/EP3088034B1/en
Publication of WO2015096740A1 publication Critical patent/WO2015096740A1/zh

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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
    • A61M25/0147—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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61M2025/015—Details of the distal fixation of the movable mechanical means
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes

Definitions

  • the invention relates to the field of medical instruments, in particular to an adjustable curved sheath tube.
  • Medical sheaths are used to establish channels, deliver or recover instruments, import drugs or to export body fluids in minimally invasive interventional and therapeutic procedures; the adjustable curved sheath tube has a distally adjustable bend function that can be reached quickly and reliably Target lesion location to reduce surgical time.
  • the end that is relatively far from the operator is the distal end, and the end that is relatively close to the operator is the proximal end.
  • the adjustable curved sheath tube disclosed in US Pat. No. 6,945,956 B2 includes a tubular body, a traction mechanism and a handle having a steering system, the traction mechanism including a developing ring disposed around a side wall of the distal elastic section of the tubular body, and a tube body
  • the pulling wire in the side wall, the distal end of the pulling wire is directly fixed on the ring wall of the developing ring by welding, and the proximal end of the pulling wire is connected with the control system.
  • the pull force is generally large at the maximum bend angle, up to 5 kg. If a larger instrument is transported in the distally bent state, the instrument itself will exert a certain back tension of the curved channel, so that the pulling force of the pulling wire is greater, thereby placing higher demands on the tensile strength of the traction system. Under normal circumstances, the medical sheath requires a larger inner diameter, the smaller the outer diameter, the better the outer diameter is small, the damage to the human blood vessel can be reduced, and the inner diameter can transport a larger instrument, so the tube wall of the tube body must be as large as possible.
  • Thin that is, the volume of the portion of the traction system in the wall of the pipe must be as small as possible so as to be wrapped in the pipe wall to reduce the wall thickness of the pipe wall.
  • the doctor will repeatedly perform the bending operation, and need to continuously and accurately adjust the angle of the distal end of the tube body so that the bending angle can adapt to the complex anatomy of the lumen of different human bodies, and the traction system is required to be repeatedly adjusted.
  • the traction wire is usually thin, and the corresponding welding area is small. Not only the welding process is difficult, but also the stress concentration of the welding spot, the change of the section size, the surface morphology change and the residual stress.
  • the physical strength after welding is only half or less when not welded, the material strength is significantly reduced, resulting in insufficient tensile strength and low reliability of the traction wire; not only the welding process is difficult to control, but also The process pass rate is low in the process. What's more, the risk of solder joint breakage is large. After the traction force is large or after repeated bending, the solder joint is easily broken, which causes the product to lose the bend function, which leads to surgical failure and even damage to the human body.
  • the welding is a rigid connection, it is difficult to withstand repeated bending requirements, and the fatigue strength is poor. If a thicker pulling wire is replaced for this, the wall thickness of the pipe body is increased, which greatly reduces the passage performance of the sheath and the flexibility of the pipe body.
  • U.S. Patent No. 7,553,305 B2 uses a fixed anchor to perform a part of the function of the developing ring.
  • the anchor is coupled to the distal end of the traction wire and overmolded within the sidewall of the tubular body, at least one end having a skirt around the axial direction of the traction wire. Pulling the pulling wire, the traction force is transmitted to the fixed anchor, and the fixed anchor acts as the force bearing body to drive the end of the pipe body to realize the bending function.
  • the anchor has a skirt that is unfolded around the radial direction of the traction wire. Because the skirt has a large diameter, the side wall must have sufficient thickness to completely cover the anchor; and the medical sheath requires that the sidewall thickness of the tube be as small as possible. The skirt is bound to increase the wall thickness of the sheath. In the case of a certain size of the delivery lumen, if the outer diameter of the tube is large, the device of the same specification will be more damaged to the human body when it enters the human body.
  • the fixed anchor is an elongated structure along the axial direction of the tubular body, and the tubular body is further provided with a developing ring at the distal end of the fixed anchor, so that the length of the rigid section at the distal end of the tubular body is increased, and the flexibility of the elastic curved section is lowered.
  • the distal end deflection radius of the tubular body of the structure is larger than that of the tubular body with a short rigid section, which affects the flexibility of the sheath during the propulsion process, and is smaller. In the human body lumen of space, if the deflection radius is large, there is not enough space for the sheath to bend.
  • the technical problem to be solved by the present invention is to provide an adjustable curved sheath tube for the defects of the prior art.
  • an adjustable curved sheath tube comprising a tube body, a traction mechanism and a fixed connection mechanism;
  • the traction mechanism comprises an anchoring ring and a pulling wire;
  • the anchoring ring Coaxially embedded in the distal elastic section of the tubular body;
  • the traction wire is disposed in a sidewall of the tubular body and extends along an axial direction of the tubular body, and the traction wire comprises an interconnecting wire
  • the first segment and the second segment the first segment being coupled to the fixed attachment mechanism adjacent the proximal end of the tubular body, the second segment hooking the anchoring ring.
  • the second section is bent at a distal end surface of the anchoring ring and extends toward a proximal end of the tubular body, and the fixed connection mechanism fixed.
  • the side wall of the tubular body is provided with two mutually parallel traction wire passages, the traction wire passages extending along the axial direction of the tubular body, the traction The wire is received in the traction wire passage.
  • the second segment is fixedly coupled to the anchoring ring after being bent at a distal end surface of the anchoring ring.
  • the second section is fixedly coupled to the anchoring ring by welding or gluing.
  • the second segment is fixedly coupled to the first segment after being bent at a distal end surface of the anchor ring.
  • the second segment is fixedly coupled to the first segment by a steel sleeve, a heat shrinkable tube, a weld or a glue.
  • the second section also hooks the proximal end face of the anchoring ring after being bent at the distal end face of the anchoring ring.
  • the portion of the second segment for hooking the anchoring ring is subjected to an annealing treatment at 300 ° C to 500 ° C.
  • the pulling wire hooks the anchoring ring, so the force receiving point between the anchoring ring and the pulling wire is a hooking portion between each other, and the connecting mode is similar to the flexible state.
  • the connection ensures the connection strength and the connection stability between the two; in addition, the traction mechanism has a simple structure, no additional components are needed or the structure is improved, and only the connection mode of the traction wire and the anchor ring needs to be changed, so there is no need to increase
  • the size of the large anchoring ring and the pulling wire does not have a significant effect on the thickness of the side wall of the tube.
  • FIG. 1 is a schematic structural view of a bendable sheath tube according to a first embodiment of the present invention
  • Figure 2 is a schematic cross-sectional view of the tubular body of the adjustable curved sheath tube of Figure 1;
  • Figure 3 is a schematic view of the traction mechanism and the fixed connection mechanism of the adjustable curved sheath tube of Figure 1;
  • Figure 4 is a partial cross-sectional view of the adjustable curved sheath of Figure 1;
  • Figure 5 is a partial cross-sectional view of the adjustable curved sheath of Figure 1;
  • Figure 6 is a schematic cross-sectional view of the traction wire tube of the adjustable curved sheath tube of Figure 1;
  • Figure 7 is a schematic view showing the adjustment of the adjustable curved sheath tube of Figure 1;
  • Figure 8 is a schematic view of a traction mechanism of a bendable sheath tube according to a second embodiment of the present invention.
  • Figure 9 is a schematic view of a traction mechanism of an adjustable curved sheath tube according to a third embodiment of the present invention.
  • Figure 10 is a schematic view of the traction mechanism of the adjustable curved sheath tube of the fourth embodiment of the present invention.
  • an adjustable curved sheath tube 100 includes a tubular body 110, a traction mechanism 120, a fixed connection mechanism 130, and a handle 140.
  • the proximal end of the tubular body 110 is fixedly coupled to the handle 140; the traction mechanism 120 extends axially within the sidewall of the tubular body 110 and is coupled to a fixed attachment mechanism 130 located within the handle 140 adjacent the proximal end of the tubular body 110.
  • the tubular body 110 includes a distal elastic section 111 and a proximal rigid section 112 having different elastic moduli in the axial direction, and the proximal rigid section 112 is fixedly coupled to the handle 140.
  • the inner layer 113, the intermediate layer 114 surrounding the inner layer 113, and the outer layer 115 are sequentially arranged in the radial direction; the inner layer 113 is made of polytetrafluoroethylene, the intermediate layer 114 is a metal spring tube or a braided mesh tube, and the outer layer 115 is made of thermoplastic.
  • the thermoplastic includes nylon, a polyether-polyamide block copolymer, and the like.
  • the thermoplastic material from which the outer layer 115 is prepared is melted to sufficiently bond with the polytetrafluoroethylene of the inner layer 113 to form the tube body 110.
  • the inner layer 113 surrounds a delivery lumen 117 that extends continuously from the distal end to the proximal end of the tubular body 110; the inner layer 113, the intermediate layer 114, and the outer layer 115 together form a sidewall.
  • the traction mechanism 120 includes an anchoring ring 121 and a pulling wire 122 coaxially embedded in the side wall of the distal elastic section 111 and surrounding the inner layer 113; the pulling wire 122 is disposed on the side wall of the pipe body 110 Inside, and extending along the axial direction of the pipe body 110.
  • One section of the pulling wire 122 hooks the anchoring ring 121 and the other section is connected to the fixed connection mechanism 130.
  • the traction wire 122 passes through the annular wall of the anchoring ring 121 to hook the anchoring ring 121; or the distal end surface of the anchoring ring 121 is bent to hook the anchoring ring 121.
  • the traction wire 122 hooks the anchor ring 121 in the distal end region of the anchoring ring 121.
  • the traction wire 122 includes an axially parallel first and second traction wire segments 122a and 122b, and a bent portion connecting the distal end of the first traction wire segment 122a and the distal end of the second traction wire segment 122b. 122c.
  • the first traction wire segment 122a and the second traction wire segment 122b each extend axially through the side wall and are coupled to the fixed connection mechanism 130 near the proximal end of the tubular body 110; the first traction wire segment 122a and the second traction wire segment 122b are respectively located on opposite sides (inside and outside the ring) of the anchoring ring 121, and the bent portion 122c spans the distal end surface 121a of the anchoring ring 121 to hook the anchoring ring 121.
  • the anchoring ring 121 may be made of a heavy metal such as stainless steel, platinum, gold, tungsten or rhenium having a thickness of about 0.05 mm to 0.30 mm or an alloy thereof.
  • the anchoring ring 121 is coaxially looped over the outer wall of the inner layer 113, the second pulling wire segment 122b passes through the gap between the inner side of the anchoring ring 121 and the inner layer 113, and the first pulling wire segment 122a passes through the anchoring ring 121.
  • the bent portion 122c is brought into close contact with the anchoring ring 121, and the first and second pulling wire segments 122a and 122b are kept flush.
  • the pulling wire 122 may be a circular or flat wire having a diameter of about 0.05 to 0.25 mm.
  • the length of the wire is at least twice the axial length of the pipe body 110, and stainless steel wire, tungsten alloy steel wire, cobalt chromium alloy steel wire or Nitinol steel wire, etc.
  • the bent wire 122 is bent to form the bent portion 122c, the portion to be bent is first annealed. When annealing, different annealing temperatures are selected according to the material of the wire, and then the pulling wire 122 is bent by 135° to 225° to form A circular arc-shaped bent portion 122c having a radius of curvature of about 0.1 mm to 0.4 mm.
  • a pulling wire tube 116 for accommodating the pulling wire 122 is further disposed in the side wall of the pipe body 110, and the cavity wall is made of polytetrafluoroethylene.
  • the traction wire tube 116 is disposed between the inner layer 113 and the intermediate layer 114, and can be fixed to the inner layer 113 by welding, bonding, or welding; in the axial direction, the traction wire tube 116 is near the proximal end of the anchoring ring 121.
  • the tubular body 110 extends between the proximal ends.
  • the tubular body 110 includes two independent, axially parallel traction wire passages 116a and 116b.
  • the traction wire tube 118 includes axially parallel first and second traction wire passages 118a and 118b, and traction wires that enclose the first and second traction wire passages 118a and 118b.
  • the tube wall 118c, the leash tube wall 118c is made of polytetrafluoroethylene.
  • the fixed connection mechanism 130 in the knob 141 is moved by an existing, any suitable means, and the fixed connection mechanism 130 transmits the force and displacement to the traction wire.
  • the traction wire 122 is axially moved relative to the tubular body 110, and then the force and displacement are transmitted to the anchoring ring 121, and the distal elastic segment 111 is driven by the anchoring ring 121, because the distal elastic segment 111 and the proximal rigid segment
  • the modulus of elasticity of 112 is different, resulting in uneven deformation, causing the distal elastic section 111 to bend (see Fig. 9) to effect sheath bowing.
  • there are the following key points of force between the anchoring ring 121 and the pulling wire 122, and the pulling wire 122 itself; the tensile strength and fatigue strength of the force point determine the effectiveness of force and displacement transmission and reliability.
  • the pulling wire 122 is hooked by the bent portion 122c to the distal end surface 121a of the anchoring ring 121. Therefore, the point of contact between the anchoring ring 121 and the pulling wire 122 is the bending portion 122c and the distal end surface 121a.
  • the approach is similar to a flexible connection that ensures joint strength and stability. After the bending portion 122c is annealed, the tensile strength and the fatigue strength are hardly changed. After the bending, the bent portion 122c still has good bending performance and fatigue performance, and between the anchoring ring 121 and the pulling wire 122. The strength is substantially the same as the strength of the traction wire 122 itself, and is no longer a weak point of the force.
  • the traction mechanism has a simple structure, does not need to add additional components or improve its own structure, and only changes the structural arrangement of the traction wire 122 with respect to the anchoring ring 121, so that it is not necessary to increase the anchoring ring under the premise of satisfying tensile strength and stability.
  • 121 and the size of the pulling wire 122 the side wall of the pipe body 110 only needs to increase the diameter of the pulling wire in thickness, and the thin plastic outer layer 115 can completely enclose the traction mechanism 120, thereby effectively reducing The effect of the traction mechanism 120 on the thickness of the sidewalls.
  • the traction wire 122 is bent into two axially parallel segments, and the two sidewalls have two traction wire passages respectively accommodating the first traction wire segment 122a and the second traction wire segment 122b.
  • the decomposition of the tensile force by the first traction wire segment 122a and the second traction wire segment 122b during the adjustment can increase the tensile strength of the traction wire 122 per unit sectional area, and the traction wire can be reduced under the premise of ensuring the same tensile strength.
  • the diameter of 122 thereby reducing the thickness of the side wall of tube 110.
  • the proximal end of the second pulling wire segment 222b of the traction mechanism 220 according to the second embodiment of the present invention is fixed to the anchoring ring 221; preferably, fixed at The annular surface 221c of the anchoring ring 221, for example, the inner annular surface, and the connection point 220b is formed, and can be fixed by welding or gluing.
  • the force receiving point between the traction wire 222 and the anchoring ring 221 is still the bending portion 222c and the distal end surface 221a, which can also ensure tensile strength and stability; meanwhile, the second traction wire
  • the segment 222b terminates on the anchoring ring 221, thus eliminating the need for the two traction wire segments 222a and 222b to extend through the sidewall simultaneously, reducing the thickness of the sidewall; and eliminating the need for two traction wire channels, simplifying the preparation of the tubular body.
  • the second pulling wire segment 322b of the traction mechanism 320 in contrast to the above-described adjustable curved sheath tube 100, is parallel to the first end face 321b of the anchoring ring 321
  • the traction wire segment 322a is fixedly connected.
  • the two traction wire segments 322a and 322b can be fixedly connected by a steel sleeve, a heat shrinkable tube, a welded or an adhesive, and the two traction wire segments 322a and 322b are shown fixedly connected by a steel sleeve 323.
  • the force receiving point between the traction wire 322 and the anchoring ring 321 is still the bending portion 322c and the distal end surface 321a, which can also ensure tensile strength and stability;
  • the second traction wire segment 322b terminates near the anchoring ring 321 so that the two wire segments 322a and 322b are not required to pass through the sidewall simultaneously, reducing the thickness of the sidewall; and eliminating the need for two traction wire passages, simplifying the preparation of the tubular body Difficulty.
  • the second traction wire segment 422b of the traction mechanism 420 is bent across the proximal end surface 421b of the anchoring ring 421 to The proximal end surface 421b is housed, where the second bent portion 422d is formed, and then extends toward the distal end surface 421a of the anchoring ring 421 and abuts against the annular surface 421c.
  • additional fixing methods such as welding or gluing
  • fixing members such as steel sleeves
  • the pulling wire segment 422b is firmly attached to the anchoring ring 421; and because of the second bent portion 422d, the pulling force exerted on the pulling wire 422 is rarely transmitted to the second pulling wire segment 422b to be in close contact with the annular surface 421c. At the end, the point of force between the pulling wire 422 and the anchoring ring 421 is still the first bent portion 422c and the distal end surface 421a, ensuring tensile strength.

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

Abstract

一种可调弯鞘管（100），包括管体（110）、牵引机构（120）和固定连接机构（130）。牵引机构（120）包括锚定环（121）和牵引丝（122）。锚定环（121）同轴地嵌设在管体（110）的远端弹性段（111）内。牵引丝（122）设于管体（110）的侧壁内，且沿管体（110）的轴向延伸。牵引丝（122）包括相互连接的第一段和第二段，第一段在管体（110）的近端附近与固定连接机构（130）连接，第二段勾住锚定环（121）。

Description

可调弯鞘管
【技术领域】
本发明涉及医疗器械领域，尤其涉及一种可调弯鞘管。
【背景技术】
医用鞘管在微创介入诊断和治疗手术中用于建立通道、输送或回收器械、输入药物或导出体液等；其中的可调弯鞘管具有远端可调弯功能，能快速、可靠地到达靶病变位置，以减少手术时间。在微创介入领域通常定义距操作者相对远的一端为远端，距操作者相对近的一端为近端。
美国专利文献US6945956B2公开的可调弯鞘管包括管体、牵引机构和具有操控***的手柄，牵引机构包括环绕设置在管体的远端弹性段的侧壁内的显影环、以及设于管体侧壁内的牵引丝，牵引丝的远端通过焊接直接固定在显影环的环壁上，牵引丝的近端与操控***连接。通过操控***拉动牵引丝，将力和位移传递至牵引丝，使牵引丝在管体轴向方向上相对运动，继而通过焊点将力和位移传递给显影环，带动管体的远端弹性段弯曲，实现管体远端可调弯。
基于可调弯鞘管的直径尺寸以及调弯角度范围的要求，一般达到最大调弯角度时的拉力较大，最大可达5公斤力。如果在远端弯曲状态下再输送较大的器械，器械自身又会施加弯曲通道一定的背向张力，使牵引丝受到的拉力更大，从而对牵引***的拉伸强度提出更高的要求。通常情况下，医用鞘管要求内径越大越好，外径越小越好，外径小可以减少对人体血管的损伤，内径大可以输送更大的器械，因此要求管体的管壁必须尽量的薄，即要求牵引***在管壁内的部分的体积必须尽量小，以便于包覆在管壁内，减小管壁的壁厚。手术前和手术过程中医生都会反复进行调弯操作，并需要连续地精确地调节管体远端的角度，使其弯曲角度适应不同的人体内管腔的复杂解剖结构，反复调节要求牵引***具有较好的牵拉疲劳性能。因此，牵引***的拉伸强度、拉伸疲劳强度和对管体壁厚的影响在可调弯鞘管中至关重要。
牵引丝通常较细，对应的焊接面积小，不仅焊接工艺难度大，还将导致焊点应力集中、断面尺寸改变、表面形态改变和残余应力等。另，根据金属焊接理论可知，焊接后的物理强度只有非焊接时的一半或更少，材料强度显著降低，造成牵引丝的拉伸强度不够且可靠度较低；不仅焊接工艺过程难控制，而且过程中工序合格率较低。更甚者，焊点断裂的风险大，在牵引力较大或经反复弯曲后，焊点部位极易发生断裂，致使产品失去调弯功能，从而导致手术失败甚至对人体造成伤害。另，焊接为刚性连接，难以经受反复的调弯需求，疲劳强度较差。如果针对此更换较粗的牵引丝，则会加大管体的壁厚，大大降低鞘管的通过性能和管体的柔顺性。
针对于此，美国专利文献US7553305B2采用固定锚实施显影环的一部分功能。固定锚与牵引丝的远端连接，且包覆成型在管体的侧壁内，至少一端具有围绕牵引丝轴向方向的裙边。拉动牵引丝，牵引力作传递至固定锚，固定锚作为受力承载体带动管体的末端实现调弯功能。
固定锚具有围绕牵引丝径向方向展开的裙边，因裙边直径较大，侧壁须有充足的厚度才能完全包覆固定锚；而医用鞘管要求管体的侧壁厚须尽量小，裙边势必会增加鞘管的壁厚。在输送内腔尺寸一定的情况下，如果管体外径较大，输送相同规格的器械进入人体时对人体的产生损伤更大。且，固定锚为沿管体轴向的长形结构，而管体在相对固定锚的远端还设有显影环，使得管体远端刚性段的长度增加，弹性调弯段的柔顺性降低，当管体远端弯曲到一定的角度时，相比于刚性段短的管体，此种结构的管体远端偏转半径更大，影响鞘管在推进过程中的灵活性，在较小空间的人体管腔内，如果偏转半径大，则没有足够的空间提供给鞘管弯曲。
【发明内容】
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种可调弯鞘管。
本发明解决其技术问题所采用的技术方案是：提供一种可调弯鞘管，包括管体、牵引机构和固定连接机构；所述牵引机构包括锚定环和牵引丝；所述锚定环同轴地嵌设在所述管体的远端弹性段内；所述牵引丝设于所述管体的侧壁内，且沿所述管体的轴向延伸，所述牵引丝包括相互连接的第一段和第二段，所述第一段在所述管体的近端附近与所述固定连接机构连接，所述第二段勾住所述锚定环。
在根据本发明实施例的可调弯鞘管中，所述第二段在所述锚定环的远端端面处弯折后朝所述管体的近端延伸，并与所述固定连接机构固定。
在根据本发明实施例的可调弯鞘管中，所述管体的侧壁设有两个相互平行的牵引丝通道，所述牵引丝通道沿所述管体的轴向延伸，所述牵引丝收容于所述牵引丝通道内。
在根据本发明实施例的可调弯鞘管中，所述第二段在所述锚定环的远端端面处弯折后与所述锚定环固定连接。
在根据本发明实施例的可调弯鞘管中，所述第二段通过焊接或胶粘与所述锚定环固定连接。
在根据本发明实施例的可调弯鞘管中，所述第二段在所述锚定环的远端端面处弯折后与所述第一段固定连接。
在根据本发明实施例的可调弯鞘管中，所述第二段与所述第一段通过钢套、热缩管、焊接或胶粘固定连接。
在根据本发明实施例的可调弯鞘管中，所述第二段在所述锚定环的远端端面处弯折后还勾住所述锚定环的近端端面。
在根据本发明实施例的可调弯鞘管中，所述第二段用于勾住所述锚定环的部分经过了300℃~500℃的退火处理。
在依据本发明技术方案的可调弯鞘管中，牵引丝勾住锚定环，因此锚定环与牵引丝之间的受力点为彼此之间的勾住部分，该连接方式近似于柔性连接，可确保两者之间的连接强度和连接稳定性；另，牵引机构结构简单，无需额外增加部件或改进自身结构，仅需改变牵引丝与锚定环的连接方式即可，因此无需增大锚定环和牵引丝的尺寸，不会对管体侧壁厚度产生明显影响。
【附图说明】
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明第一实施例的可调弯鞘管结构示意图；
图2是图1中可调弯鞘管的管体的截面示意图；
图3是图1中可调弯鞘管的牵引机构与固定连接机构的示意图；
图4是图1中可调弯鞘管的局部剖视图；
图5是图1中可调弯鞘管的局部剖视图；
图6是图1中可调弯鞘管的牵引丝管的截面示意图；
图7是图1中可调弯鞘管的调弯示意图；
图8是本发明第二实施例的可调弯鞘管的牵引机构的示意图；
图9是本发明第三实施例的可调弯鞘管的牵引机构的示意图；
图10是本发明第四实施例的可调弯鞘管的牵引机构的示意图。
【具体实施方式】
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
参见图1到图5，依据本发明第一实施例的可调弯鞘管100包括管体110、牵引机构120、固定连接机构130以及手柄140。管体110的近端与手柄140固定连接；牵引机构120轴向延伸嵌设在管体110的侧壁内，并在管体110的近端附近与位于手柄140内的固定连接机构130连接。
管体110在轴向上包括弹性模量不同的远端弹性段111和近端刚性段112，近端刚性段112与手柄140固定连接。在径向上依次包括内层113、环绕内层113的中间层114以及外层115；内层113由聚四氟乙烯制成，中间层114为金属弹簧管或者编织网管，外层115由热塑性塑料制成，该热塑性塑料包括尼龙、聚醚-聚酰胺嵌段共聚物等。在包覆成型中，将制备外层115的热塑性材料熔融，使其与内层113的聚四氟乙烯充分结合，以形成管体110。内层113围绕形成输送内腔117，该输送内腔117从管体110的远端到近端连续贯穿；内层113、中间层114和外层115共同形成侧壁。
牵引机构120包括锚定环121和牵引丝122，锚定环121同轴地嵌设在远端弹性段111的侧壁内，并环绕内层113；牵引丝122设于管体110的侧壁内，并沿管体110的轴向延伸。牵引丝122的一段勾住锚定环121，另一段与固定连接机构130连接。例如，牵引丝122穿过锚定环121的环壁而勾住锚定环121；或者弯折跨过锚定环121的远端端面勾出锚定环121。优选地，牵引丝122在锚定环121的远端区域勾住锚定环121。
具体地，牵引丝122包括轴向平行的第一牵引丝段122a和第二牵引丝段122b、以及连接第一牵引丝段122a的远端与第二牵引丝段122b的远端的弯折部122c。第一牵引丝段122a和第二牵引丝段122b均轴向延伸穿过侧壁，且在管体110的近端附近与固定连接机构130连接；第一牵引丝段122a和第二牵引丝段122b分别位于锚定环121的相对两侧（环内和环外），弯折部122c跨过锚定环121的远端端面121a，以勾住锚定环121。
锚定环121可采用厚度约0.05mm～0.30mm的不锈钢、铂、黄金、钨、钽等重金属或者其合金制成。锚定环121同轴地环套在内层113的外壁上，第二牵引丝段122b穿过锚定环121内侧与内层113之间的缝隙，第一牵引丝段122a通过锚定环121的外侧，使弯折部122c紧贴锚定环121，第一牵引丝段122a和第二牵引丝段122b保持平齐。
牵引丝122可采用直径约为0.05～0.25mm的圆形或者扁平金属丝，金属丝的长度至少为管体110轴向长度的两倍，可采用不锈钢丝、钨合金钢丝、钴铬合金钢丝或者镍钛合金钢丝等。弯折牵引丝122形成弯折部122c时，先对欲弯折部分进行退火处理，退火时根据金属丝的材质选用不同的退火温度，然后将牵引丝122弯折135°~225°，以形成曲率半径约0.1mm~0.4mm的圆弧形弯折部122c。
参见图2至图5，管体110的侧壁内还设有用于收容牵引丝122的牵引丝管116，其腔壁由聚四氟乙烯制成。牵引丝管116设置在内层113与中间层114之间，可通过焊接、粘结、或者熔接固定在内层113上；轴向上，牵引丝管116在锚定环121的近端附近与管体110的近端之间延伸。此处，管体110包括两根独立的、且轴向平行的牵引丝通道116a和116b。替换地，参见图6，牵引丝管118包括轴向平行的第一牵引丝通道118a和第二牵引丝通道118b、以及围合形成第一牵引丝通道118a和第二牵引丝通道118b的牵引丝管壁118c，牵引丝管壁118c由聚四氟乙烯制成。
参见图1和图7，可调弯鞘管100的调弯过程中，通过现有的、任意适合的方式移动旋钮141内的固定连接机构130，固定连接机构130将力和位移传递至牵引丝122，使牵引丝122相对管体110轴向移动，继而将该力和位移传递至锚定环121，通过锚定环121带动远端弹性段111，因远端弹性段111与近端刚性段112的弹性模量不同，产生不均形变，使该远端弹性段111弯曲（参见图9），实现鞘管调弯。该调弯过程中，存在以下关键受力点：锚定环121与牵引丝122之间、以及牵引丝122本身；受力点的拉伸强度和疲劳强度决定了力和位移传递的有效性和可靠性。
牵引丝122通过其弯折部122c勾住锚定环121的远端端面121a，因此锚定环121与牵引丝122之间的受力点即为弯折部122c与远端端面121a，该连接方式近似于柔性连接，可确保连接强度和稳定性。且弯折部122c经过退火处理后，其拉伸强度和疲劳强度几乎不改变，调弯后，弯折部122c仍具有较好的弯曲性能和疲劳性能，锚定环121与牵引丝122之间的强度与牵引丝122本身的强度基本相同，不再是受力薄弱点，相比现有技术中锚定环与牵引丝之间的直接焊接连接方式，其在稳定性方面具有明显优势。另外，牵引机构结构简单，无需额外增加部件或改进自身结构，仅改变牵引丝122相对锚定环121的结构设置，因此，在满足拉伸强度和稳定性的前提下，无需增大锚定环121和牵引丝122的尺寸，管体110的侧壁在厚度上仅需增加牵引丝的直径而已，对此采用较薄的塑料外层115即可完全包埋住牵引机构120，从而有效减小了牵引机构120对侧壁厚度的影响。
另，本实施例中，牵引丝122弯折为轴向平行的两段，与之配合的，侧壁中具有分别容纳第一牵引丝段122a和第二牵引丝段122b的两个牵引丝通道，以避免牵引丝段之间的缠绕。且，调弯中第一牵引丝段122a和第二牵引丝段122b对拉力的分解可提高单位截面积的牵引丝122的拉伸强度，在确保相同拉伸强度的前提下，可降低牵引丝122的直径，从而减小管体110侧壁的厚度。
参见图8，与上述可调弯鞘管100不同的是，依据本发明第二实施例的牵引机构220的第二牵引丝段222b的近端固定在锚定环221上；优选地，固定在锚定环221的环面221c上，例如内环面上，并形成连接点220b，可采用焊接或胶粘的方式进行固定。拉动第一牵引丝段222a，牵引丝222与锚定环221之间的受力点仍为弯折部222c与远端端面221a，同样能确保拉伸强度以及稳定性；同时，第二牵引丝段222b终止于锚定环221上，因此无需两个牵引丝段222a和222b同时延伸穿过侧壁，减少了侧壁厚度；且无需两个牵引丝通道，简化了管体的制备难度。
参见图9，与上述可调弯鞘管100不同的是，依据本发明第三实施例的牵引机构320的第二牵引丝段322b在锚定环321的近端端面321b附近与平行的第一牵引丝段322a固定连接。两个牵引丝段322a和322b之间可通过钢套、热缩管、焊接或胶粘固定连接，图中示出两牵引丝段322a和322b通过钢套323夹紧的方式固定连接。此时，拉动第一牵引丝段322a过程中，牵引丝322与锚定环321之间的受力点仍为弯折部322c与远端端面321a，同样能确保拉伸强度以及稳定性；同时，第二牵引丝段322b终止于锚定环321附近，因此无需两牵引丝段322a和322b同时穿过侧壁，减少了侧壁厚度；且无需两个牵引丝通道，简化了管体的制备难度。
参见图10，与上述可调弯鞘管100不同的是，依据本发明第四实施例的牵引机构420的第二牵引丝段422b弯折跨过锚定环421的近端端面421b，以勾住该近端端面421b，在此形成第二弯折部422d，随后向锚定环421的远端端面421a延伸并贴紧其环面421c。此处无需其它额外固定方式（例如焊接或胶粘）或固定件（例如钢套）固定第二牵引丝段422b，在管体外层的包覆成型过程中，其压合作用即可将第二牵引丝段422b稳固贴紧锚定环421；且因具有第二弯折部422d，施加在牵引丝422上的拉力很少能传递至第二牵引丝段422b紧贴在环面421c上的自由端，牵引丝422与锚定环421之间的受力点仍为第一弯折部422c与远端端面421a，确保了拉伸强度。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换或改进等，均应包含在本发明的保护范围之内。

Claims (9)

  1. 一种可调弯鞘管，包括管体、牵引机构和固定连接机构；所述牵引机构包括锚定环和牵引丝；所述锚定环同轴地嵌设在所述管体的远端弹性段内；所述牵引丝设于所述管体的侧壁内，且沿所述管体的轴向延伸，所述牵引丝包括相互连接的第一段和第二段，其特征在于，所述第一段在所述管体的近端附近与所述固定连接机构连接，所述第二段勾住所述锚定环。
  2. 根据权利要求1所述的可调弯鞘管，其特征在于，所述第二段在所述锚定环的远端端面处弯折后朝所述管体的近端延伸，并与所述固定连接机构固定。
  3. 根据权利要求2所述的可调弯鞘管，其特征在于，所述管体的侧壁设有两个相互平行的牵引丝通道，所述牵引丝通道沿所述管体的轴向延伸，所述牵引丝收容于所述牵引丝通道内。
  4. 根据权利要求1所述的可调弯鞘管，其特征在于，所述第二段在所述锚定环的远端端面处弯折后与所述锚定环固定连接。
  5. 根据权利要求4所述的可调弯鞘管，其特征在于，所述第二段通过焊接或胶粘与所述锚定环固定连接。
  6. 根据权利要求1所述的可调弯鞘管，其特征在于，所述第二段在所述锚定环的远端端面处弯折后与所述第一段固定连接。
  7. 根据权利要求6所述的可调弯鞘管，其特征在于，所述第二段与所述第一段通过钢套、热缩管、焊接或胶粘固定连接。
  8. 根据权利要求1所述的可调弯鞘管，其特征在于，所述第二段在所述锚定环的远端端面处弯折后还勾住所述锚定环的近端端面。
  9. 根据权利要求1～8任一项所述的可调弯鞘管，其特征在于，所述第二段用于勾住所述锚定环的部分经过了300℃~500℃的退火处理。
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