WO2019015400A1 - 一种自然腔道手术用可展变刚度蛇形载体及其应用方法 - Google Patents

一种自然腔道手术用可展变刚度蛇形载体及其应用方法 Download PDF

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Publication number
WO2019015400A1
WO2019015400A1 PCT/CN2018/088647 CN2018088647W WO2019015400A1 WO 2019015400 A1 WO2019015400 A1 WO 2019015400A1 CN 2018088647 W CN2018088647 W CN 2018088647W WO 2019015400 A1 WO2019015400 A1 WO 2019015400A1
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Prior art keywords
braided
braided tube
stiffness
wire
expandable
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Ceased
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PCT/CN2018/088647
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English (en)
French (fr)
Inventor
王树新
尚祖峰
任旭阳
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Tianjin University
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Tianjin University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; 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
    • A61M2025/0064—Catheters; 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 which become stiffer or softer when heated

Definitions

  • the present disclosure belongs to the field of natural cavity surgery, and relates to a expandable stiffness serpentine carrier for natural cavity surgery and an application method thereof.
  • natural orifice transluminal endoscopic surgery has less interference to the internal environment, has less pain, shorter hospital stay, and no scar on the skin.
  • the so-called natural cavity surgery refers to the surgical mode in which the surgical tool enters the inside of the human body through the orifice of the human body, including the mouth, vagina, and anus, and reaches the lesion for surgical operation.
  • Surgical tools need to have the function of passing water and passing light to transport the cut tissue.
  • the surgical tool reaches the lesion through the human body cavity, and the surgical operation is performed by the front end of the control tool such as a wire drive, including surgical operations such as cutting, suturing, and knotting, and the elongated tool is withdrawn after the end of the operation.
  • the purpose of the present disclosure is to overcome the deficiencies of the existing surgical tools, and to provide an expandable serpentine carrier with variable stiffness and an application method thereof, which can ensure the operation precision of the surgical tool while protecting the human body through the transformation of the rigid and soft state; Change the contradiction between the scale solution tool and the human body channel scale.
  • One aspect of the present disclosure provides a expandable stiffness serpentine carrier for natural lumen surgery, comprising a braided tube formed by spirally winding a plurality of braided wires; the braided wire is a hollow tubular structure.
  • a hot melt adhesive coated at a cross node of the braided wire further comprising a hot melt adhesive coated at a cross node of the braided wire; the hardness of the hot melt adhesive varies with temperature, and the stiffness of the braided tube follows heat The hardness of the melt changes.
  • the braided wire is internally filled with a medium that is transported within the braided wire, utilizing heat transfer to transfer heat between the media and the hot melt adhesive.
  • the braided wire includes a plurality of sequentially arranged left-handed spirals and right-handed spirals, and the left-handed spirals and the right-handed spirals are cross-wound to form a braided tube; the left-handed spiral and the right-handed spiral are two The end is provided with an end joint for connecting the left-handed spiral to the right-handed spiral as a passage.
  • the front end of the left-handed helix and the front end of the right-handed helix are communicated by the end joint; at the rear end of the braided tube, one of the left-handed helix and one right-handed
  • the openings of the spiral are not connected to each other, and are used as input and output ports of the braided wire for inputting and outputting liquid into the braided wire.
  • the rear ends of the other left-handed spirals and the rear end of the right-handed spiral are communicated by the end joints.
  • the hot melt adhesive employs at least two hot melt adhesives having different softening temperatures, respectively applied to different regions of the braided tube for achieving localized regional stiffness; and/or The surface of the hot melt adhesive is coated with latex to limit the position of the hot melt adhesive and prevent the hot melt adhesive from sticking to each other.
  • a driving wire for applying an axial force to the braided tube, adjusting a diameter and a degree of bending of the braided tube; and/or an elastic rubber ring disposed on the outer circumference of the braided tube, A radial force is applied to the braided tube to restore the braided tube from a large diameter to a small diameter.
  • the front end of the drive wire is coupled to the front end of the braided tube and extends rearwardly through the intersection node in the axial direction to increase the diameter of the braided tube by stretching the rear end of the wire.
  • Another aspect of the present disclosure provides a method of using the expandable stiffness serpentine carrier described above for a natural lumen procedure, comprising the steps of: S1: introducing a heat medium into the braided wire, the braided tube exhibiting a soft state, Small diameter state; S2: the braided tube is extended into the natural cavity; S3: the diameter of the braided tube is increased, and the cold medium is introduced into the braided wire, and the braided tube assumes a rigid state and a large diameter state; S4: a surgical operation in the braided tube The tool performs a surgical operation; S5: After the operation, the heat medium is introduced into the braided wire, and the braided tube is restored to a soft state and a small diameter state, and the braided tube is withdrawn from the natural cavity.
  • step S3 includes: S31: stretching the driving wire to increase the diameter of the braided tube; S32: maintaining the pulling force, introducing a cold medium into the braided wire, and removing the pulling force after the hot melt adhesive solidifies, knitting The tube is in a rigid state and a large diameter state; the step S5 includes: S51: introducing a heat medium into the braided wire after the operation; S52: the elastic rubber ring applies radial pressure to the braided tube, and the braided tube returns to a soft state and a small diameter state; S53: The braided tube is withdrawn from the natural cavity.
  • the serpentine carrier of the present disclosure can realize the rigid-flexile two-state transformation by controlling the heat input and output after the large diameter is presented, and can protect the human body cavity from the puncture and scratch of the surgical instrument, and provide support for the surgical instrument and improve Stability, improve surgical accuracy.
  • the serpentine carrier of the present disclosure is propped up by the driving wire after entering the human body, exhibiting a large diameter state, expanding the human tissue, and providing a larger channel passage.
  • the serpentine carrier of the present disclosure can realize the controllable variable stiffness position by selecting hot melt adhesives with different softening temperatures, thereby achieving the controllable segmentation of the serpentine carrier stiffness, and more satisfying the actual needs of the surgical operation.
  • the serpentine carrier of the present disclosure has good flexibility, can realize large curvature bending, and is more capable of adapting to complex human body environment.
  • the serpentine carrier of the present disclosure exhibits a small diameter and a soft state in the process of entering the human body, and the entering process does not cause significant discomfort to the human body.
  • the present disclosure controls the heat input and output after the operation, and the serpentine carrier can exhibit a small diameter and a soft state for easy withdrawal.
  • FIG. 1 is a schematic view of a braidable tube of a malleable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 2 is a side view of a expandable stiffness serpentine carrier braided tube for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 3 is a schematic view showing the main structure of a expandable stiffness serpentine carrier for natural cavity surgery according to an embodiment of the present disclosure
  • FIG. 4 is a schematic diagram of a heat exchange system of a expandable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 5 is a schematic diagram of a driving system of a expandable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 6 is a schematic view showing a curved state of a expandable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 7 is a schematic diagram showing localized stiffness bending of a expandable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 8 is a schematic view of a tapered braided tube of a expandable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure
  • FIG. 9 is a schematic view of an elliptical braided tube of a malleable stiffness serpentine carrier for natural lumen surgery according to an embodiment of the present disclosure.
  • FIG. 10 is a flow chart of a method for using a malleable stiffness serpentine carrier for natural lumen surgery in accordance with an embodiment of the present disclosure
  • Figure 11 is a schematic view showing the use of a expandable stiffness serpentine carrier for natural lumen surgery in a complete machine according to an embodiment of the present disclosure.
  • the expandable stiffness serpentine carrier for natural cavity surgery of the present disclosure is mainly composed of a braided tube and a hot melt adhesive, and the variable stiffness function is realized by changing the state of the hot melt adhesive, and the variable scale depends on the characteristics of the braided tube and is driven by the wire. achieve.
  • the expandable stiffness serpentine carrier for natural cavity surgery of the present disclosure uses a braided tube as a base.
  • the braided wire constituting the braided tube is a plurality of equal-shaped left-handed and right-handed spirals, and multiple roots.
  • the left-handed spiral lines are arranged in sequence, and a plurality of right-handed spiral lines are sequentially arranged, and the left-handed spiral line and the right-handed spiral line are cross-wound to form a woven structure.
  • the woven structure has a tubular structure as a whole, and the inside can be passed through a surgical tool, which can function as a spacer to protect the tissue, and plays a role in supporting the tool during the operation.
  • the braided wire of the braided tube is a hollow thin tube, as shown in FIG.
  • the expandable stiffness serpentine carrier for natural endoscopic surgery has a main structure as shown in FIG. 3, which includes a braided tube 3-1, a hot melt adhesive 3-2, and an end joint 3-3.
  • Each intersection of the left-handed spiral and the right-handed spiral forms an intersection, and a plurality of intersections are formed, and the intersection of each intersection is distributed along the axial direction of the braided tube, wherein a part of the intersection of the intersections is coated
  • the hot melt adhesive is applied, and the intersection of the other part of the intersection point is frictionally contacted, and the intersections of the two parts are arranged in phase.
  • the disclosure is not limited thereto, and the intersection of all the intersections may be coated with a hot melt adhesive.
  • the hot melt adhesive 3-2 is applied at the intersection of the braided tube 3-1, and the hot melt adhesive 3-2 is coated with latex to limit the position of the hot melt adhesive and prevent the hot melt adhesive from sticking to each other.
  • the two ends of the braided tube are connected by the end joint 3-3, and a flexible silicone tube can be used to make all the braided wires (thin tubes) form a passage.
  • the connection between the braided wires is: in the braided tube
  • the front end of the adjacent left-handed spiral and the front end of the right-handed spiral are connected by the end joint 3-3.
  • a left-handed spiral and a right-handed spiral are not connected to each other.
  • the rear end of the other adjacent left-handed spiral and the rear end of the right-handed spiral are also connected by the end joint 3-3, and the two remaining openings serve as input and output for the spiral Input and output liquid.
  • the front end refers to one end that performs a surgical operation.
  • the change in stiffness of the expandable stiffness serpentine carrier for natural lumen surgery of the embodiments of the present disclosure is achieved by controlling the input and output of heat to change the state of the hot melt adhesive, and the control principle is as shown in FIG.
  • the liquid pump 4-2 is connected to the heat medium source 4-3 and the cold medium source 4-4, and is connected to the inlet of the braided wire of the braided tube 4-1 through a connecting pipe, and the liquid pump 4-2 can heat the heat medium source 4-3 Or the heat medium or cold medium of the cold medium source 4-4 is injected into the hollow thin tube of the braided wire, and since all the braided wires constitute one passage, the medium can fill the entire braided tube.
  • the state change of the hot melt adhesive is: when the heat medium is introduced, the hot melt adhesive becomes soft and flexible, and the braided wire (thin tube) has small restraining ability, the structure bears load capacity is poor, and the structure exhibits a soft state; In the case of a cold medium, the hot melt adhesive hardens to a solid state, has a strong restraining ability on the braided wire (thin tube), has a strong load bearing capacity, and the structure assumes a rigid state.
  • the folding of the expandable stiffness serpentine carrier for natural endoscopic surgery is controlled by the drive wire, and the control principle is shown in Fig. 5.
  • the braided tube can be easily radially extended under an external load, and the braided tube is initially in a small diameter state, and the driving wire 5-1 shown in FIG. 5 is distributed along the intersection point, one end of which is fixed to the end joint of the braided tube, and The intersections that are staggered through the intersections are sequentially extended backward.
  • the staggered passage means that at the intersection of the drive wire and the odd intersection, the drive wire is located outside the braided tube, and at the intersection of the drive wire and the even intersection, the drive wire is located inside the braided tube, or vice versa.
  • the outer wall of the braided tube is also covered with an elastic rubber ring, and the driving wire on both sides can be adjusted to increase the diameter of the braided tube, and the elastic rubber ring is removed to press the braided tube into a small diameter state.
  • the number of driving wires is 3, and the three driving wires are uniformly arranged in a circumferential array structure, that is, the braided tubes are uniformly arranged at intervals of 120° in the circumferential direction, and the axial direction is applied to the braided tubes by axially stretching three driving wires.
  • the force the structure becomes thicker, showing a large diameter state; the wire pulling force is canceled, and the braided tube is restored to a small diameter state by the pressure of the elastic rubber ring 5-2.
  • One or two drive wires are axially stretched and the braided tube will bend.
  • the disclosure is not limited thereto, and the number of driving wires may be more than three.
  • the natural stiffness can be achieved by using a malleable stiffness serpentine carrier for segmental variable stiffness for bending control.
  • Hot melt adhesives with different softening temperatures are used in different regions of the braided tube.
  • a high softening temperature material is applied to the rear end of the serpentine carrier, and a low softening temperature material is applied to the front end.
  • the back end rigidity is high and the front end rigidity is low.
  • the curved form of the serpentine carrier is as shown in Fig. 6.
  • the curved form of the serpentine carrier is shown in Fig. 7.
  • the unbent part of the figure is coated with a high softening temperature material section, and the curved part is Coating a low softening temperature material.
  • the expandable variable stiffness serpentine carrier can be used with other initial shapes of braided tubes, such as tapers, as shown in Figure 8. It is also possible to have other cross-sectional shapes, such as an elliptical shape, as shown in FIG.
  • the braided tube structure has a variety of weaving methods, including ordinary weaving, diamond weaving and triaxial weaving.
  • a second embodiment of the present disclosure provides a method for using a malleable stiffness serpentine carrier for natural cavity surgery, which is used for the above-described expandable stiffness serpentine carrier for natural cavity surgery, as shown in FIG.
  • a flow chart of a method for using a malleable stiffness serpentine carrier for natural lumen surgery, as shown in FIG. 10, includes the following steps:
  • Step S1 a heat medium is introduced into the braided wire, and the braided tube exhibits a soft state and a small diameter state.
  • the hot melt adhesive is viscous, and the state of the braided tube is a soft state and a small diameter state.
  • Step S2 Extending the braided tube into the natural cavity.
  • the braided tube exhibits a small diameter and a soft state during the process of entering the human body, and the entering process does not cause significant discomfort to the human body.
  • Step S3 increasing the diameter of the braided tube, and introducing a cold medium into the braided wire, the braided tube exhibiting a rigid state and a large diameter state.
  • Step S3 includes the following sub-steps:
  • Sub-step S31 stretching the driving wire to increase the diameter of the braided tube
  • Sub-step S32 maintaining the pulling force, introducing a cold medium into the braided wire, and the hot-melt adhesive is solidified to cancel the pulling force, and the braided tube exhibits a rigid state and a large diameter state.
  • Step S4 a surgical tool is inserted into the braided tube to perform a surgical operation.
  • FIG. 11 is a schematic view showing the use of a folded-spinning serpentine carrier for natural lumen surgery in a NOTES robotic machine according to an embodiment of the present disclosure.
  • 11-1 is a surgical tool, and all surgical tools enter the inside of the human body through the expandable stiffness serpentine carrier 11-2 of the present disclosure for surgical operation.
  • the serpentine carrier 11-2 can function as an isolation tool to protect the tissue when the surgical tool enters the human body, and functions as a multi-tool support during the surgical operation.
  • Step S5 After the operation, the heat medium is introduced into the braided wire, and the braided tube is restored to a soft state and a small diameter state, and the braided tube is withdrawn from the natural cavity.
  • Step S5 includes the following sub-steps:
  • Sub-step S51 introducing a heat medium into the braided wire after the operation
  • Sub-step S52 the elastic rubber ring applies radial pressure to the braided tube, and the braided tube returns to a soft state and a small diameter state;
  • Sub-step S53 The braided tube is withdrawn from the natural lumen.
  • the expandable stiffness serpentine carrier for natural cavity surgery of the present disclosure has good flexibility, can realize large curvature bending, and is more capable of adapting to complex human body environment; after entering the human body By driving the wire up, it presents a large-diameter state, which expands the human body and provides a larger channel passage. After presenting a large diameter, it can display a rigid state by controlling the heat input and output, which can protect the human body cavity from the puncture of the surgical instrument. , scratching, and providing support for surgical instruments, improving stability and improving surgical precision; the variable stiffness position can be controlled by selecting hot melt adhesives with different softening temperatures, and the stiffness of the serpentine carrier can be controlled in stages, which is more suitable for surgery.
  • the serpentine carrier can exhibit a small diameter and a soft state, and is convenient to withdraw.

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Abstract

本公开提供了一种自然腔道手术用可展变刚度蛇形载体及其应用方法，蛇形载体主要由编织管及热熔胶构成，其变刚度功能依靠改变热熔胶状态实现，其变尺度依靠编织管自身特性，通过丝驱动实现。本公开提供的自然腔道手术用可展变刚度蛇形载体，具有良好的柔性，可实现大曲率弯折，适应复杂人体腔道环境能力更强，在进入人体后通过驱动丝撑起，呈现大直径状态，撑开人体组织，提供更大的腔道通路，呈现大直径后通过控制热量输入输出可实现刚柔两态转化，可保护人体腔道免受手术器械的戳伤、刮伤，并为手术器械提供支撑，提高稳定性，提升手术精度。

Description

一种自然腔道手术用可展变刚度蛇形载体及其应用方法 技术领域
本公开属于自然腔道手术领域，涉及自然腔道手术用可展变刚度蛇形载体及其应用方法。
背景技术
作为医疗领域的研究热点，自然腔道手术(natural orifice transluminal endoscopic surgery，NOTES)与传统手术模式相比，具有对内环境干扰较小，具有疼痛轻，住院时间短，皮肤无瘢痕等优点。所谓自然腔道手术，是指手术工具通过人体孔口，包括口腔、阴道、肛门等进入人体内部，并到达病灶处进行手术操作的手术模式。随着科学技术的发展，自然手术的难点正在逐步被克服，自然腔道手术正从实验走向临床，具有良好的发展前景。
目前的自然腔道手术，为适应人体结构，常采用细长柔性手术工具进行手术操作。手术工具需要具有通水通光，运送切下的组织等功能。进行手术操作时，手术工具通过人体腔道到达病灶处，通过丝驱动等控制工具前端进行手术操作，包括切割、缝合及打结等手术操作，手术结束后撤出细长工具。
此细长手术工具的实际应用中，存在两个局限：1)形状复杂的人体腔道需要工具有良好的柔顺性来避免组织损伤等，而降低工具刚度会造成器械操作精度的降低。2)手术工具功能多，结构尺寸很难降低，与人体腔道空间狭小形成矛盾，工具进入人体容易造成组织戳伤及人体不适。
公开内容
本公开目的在于克服现有手术工具的不足，提出一种具有可变刚度的可展蛇形载体及其应用方法，既可以通过刚柔状态转化保证手术工具操作精度同时又能保护人体；又可以改变尺度解决工具与人体腔道尺度的矛盾。
本公开的一个方面提供了一种自然腔道手术用可展变刚度蛇形载体，包括编织管，所述编织管由多根编织线螺旋缠绕交叉而成；所述编织线为中空管状结构。
在本公开一些示例性实施例中，还包括热熔胶，所述热熔胶涂覆在编织线的交叉节点处；所述热熔胶的硬度随温度变化，所述编织管的刚度随 热熔胶硬度的变化而变化。
在本公开一些示例性实施例中，所述编织线内部通有介质，所述介质在编织线内传输，利用热传导使热量在介质与所述热熔胶之间传递。
在本公开一些示例性实施例中，编织线包括多根顺序排列的左旋螺旋线及右旋螺旋线，左旋螺旋线与右旋螺旋线交叉缠绕形成编织管；左旋螺旋线与右旋螺旋线两端设置有端部接头，用于将左旋螺旋线与右旋螺旋线连接为通路。
在本公开一些示例性实施例中，在编织管的前端，左旋螺旋线的前端和右旋螺旋线的前端由端部接头连通；在编织管的后端，其中一个左旋螺旋线和一个右旋螺旋线的开口互不连通，作为编织线的输入口和输出口，用于向编织线内输入输出液体，其他左旋螺旋线的后端和右旋螺旋线的后端由端部接头连通。
在本公开一些示例性实施例中，所述热熔胶采用至少两种软化温度不同的热熔胶，分别涂覆于所述编织管的不同区域，用于实现局部区域变刚度；和/或所述热熔胶表面涂有乳胶，用于限制热熔胶的位置，防止热熔胶相互粘连。
在本公开一些示例性实施例中，还包括：驱动丝，用于对编织管施加轴向力，调节编织管的直径和弯曲程度；和/或弹性橡胶环，套设在编织管外周，用于对编织管施加径向力，使编织管由大直径恢复到小直径状态。
在本公开一些示例性实施例中，所述驱动丝前端与编织管前端连接，并沿轴向穿过交叉节点向后延伸，通过拉伸驱动丝后端，增大编织管的直径。
本公开的另一个方面提供了一种将上述的可展变刚度蛇形载体用于自然腔道手术的方法，包括以下步骤：S1：向编织线内通入热介质，编织管呈现柔态、小直径状态；S2：将编织管伸入自然腔道；S3：增大编织管直径，并向编织线内通入冷介质，编织管呈现刚态、大直径状态；S4：编织管内通入手术工具进行手术操作；S5：手术后向编织线内通入热介质，编织管恢复到柔态、小直径状态，将编织管撤出自然腔道。
在本公开一些示例性实施例中，步骤S3包括：S31：拉伸驱动丝使编织管直径增大；S32：保持拉力，向编织线内通入冷介质，热熔胶凝固后 取消拉力，编织管呈现刚态、大直径状态；步骤S5包括：S51：手术后向编织线内通入热介质；S52：弹性橡胶环对编织管施加径向压力，编织管恢复到柔态、小直径状态；S53：将编织管撤出自然腔道。
本公开的自然腔道手术用可展变刚度蛇形载体及其应用方法具有以下有益效果：
(1)本公开的蛇形载体呈现大直径后通过控制热量输入输出可实现刚柔两态转化，可保护人体腔道免受手术器械的戳伤、刮伤，并为手术器械提供支撑，提高稳定性，提升手术精度。
(2)本公开的蛇形载体进入人体后通过驱动丝撑起，呈现大直径状态，撑开人体组织，提供更大的腔道通路。
(3)本公开的蛇形载体可通过选用软化温度不同的热熔胶而实现变刚度位置可控，实现蛇形载体刚度分段可控，更满足手术操作实际需求。
(4)本公开的蛇形载体具有良好的柔性，可实现大曲率弯折，适应复杂人体腔道环境能力更强。
(5)本公开的蛇形载体在进入人体过程中呈现小直径、柔态，进入过程不会给人体造成明显不适感。
(6)本公开在手术后通过控制热量输入输出，蛇形载体可呈现小直径、柔态，方便撤出。
附图说明
附图是用来提供对本公开的进一步理解，并且构成说明书的一部分，与下面的具体实施方式一起用于解释本公开，但并不构成对本公开的限制。在附图中：
图1为本公开实施例的自然腔道手术用可展变刚度蛇形载体编织管示意图；
图2为本公开实施例的自然腔道手术用可展变刚度蛇形载体编织管侧视图；
图3为本公开实施例的自然腔道手术用可展变刚度蛇形载体主体结构示意图；
图4为本公开实施例的自然腔道手术用可展变刚度蛇形载体的热交换系统示意图；
图5为本公开实施例的自然腔道手术用可展变刚度蛇形载体的驱动系统示意图；
图6为本公开实施例的自然腔道手术用可展变刚度蛇形载体弯曲状态示意图；
图7为本公开实施例的自然腔道手术用可展变刚度蛇形载体局部变刚度弯曲示意图；
图8为本公开实施例的自然腔道手术用可展变刚度蛇形载体的锥形编织管示意图；
图9为本公开实施例的自然腔道手术用可展变刚度蛇形载体的椭圆形编织管示意图。
图10为本公开实施例的将可展变刚度蛇形载体用于自然腔道手术的方法流程图；
图11为本公开实施例的自然腔道手术用可展变刚度蛇形载体在整机中使用示意图。
具体实施方式
为使本公开的目的、技术方案和优点更加清楚明白，以下结合具体实施例，并参照附图，对本公开进一步详细说明。
此处描述提供具体的实施例，但无意限制本公开的使用范围、适用性和具体结构构造，本实施反而为本领域普通技术人员根据已知条件来实施本公开的实施方式，可对组件的具体功能参数和排布进行改变。因此，各种实施方式可适当的省略、取代或者添加步骤或者相关类似组件。例如，应理解可以和描述的顺序不同的顺序来实施方法，也可以和描述的参数不同的参数来实施方法，且可以添加、省略或组合各种步骤。此外，相对于某些实施方式描述参数和方法，可与其他实施方式进行结合。
本公开的自然腔道手术用可展变刚度蛇形载体，主要由编织管及热熔胶构成，其变刚度功能依靠改变热熔胶状态实现，其变尺度依靠编织管自身特性，通过丝驱动实现。
本公开的自然腔道手术用可展变刚度蛇形载体，以编织管为基体，如图1所示，组成编织管的编织线为多根等量的左旋及右旋的螺旋线，多根左旋螺旋线顺序排列，多根右旋螺旋线顺序排列，左旋螺旋线与右旋螺旋 线交叉缠绕形成编织结构。编织结构整体为管状结构，内部可通入手术工具，可以起到隔离工具保护组织的作用，手术操作时起到对工具支撑的作用。由于编织线具有一定强度，且交叉处没有其他约束，此编织管稳定，柔顺性好，可大曲率弯曲。编织管的编织线为中空细管，如图2所示。自然腔道手术用可展变刚度蛇形载体，其主体结构如图3所示，其包括编织管3-1，热熔胶3-2，及端部接头3-3。左旋螺旋线与右旋螺旋线每一相交处形成一交叉点，共形成多个交叉点列，每个交叉点列的交叉点沿编织管轴向分布，其中，一部分交叉点列的交叉点涂覆热熔胶，另一部分交叉点列的交叉点摩擦接触，这两部分交叉点列相间分布。但本公开并不以此为限，也可以将全部交叉点列的交叉点涂覆热熔胶。
热熔胶3-2涂覆在编织管3-1的交叉点处，热熔胶3-2上涂有乳胶，用于限制热熔胶的位置，防止热熔胶相互粘连。编织管的两端由端部接头3-3连通，可采用柔性良好的硅胶管，使所有编织线(细管)构成一个通路，本实施例中编织线之间的连接方式为：在编织管的前端，相邻的左旋螺旋线的前端和右旋螺旋线的前端由端部接头3-3连通，在编织管的后端，需保留一个左旋螺旋线和一个右旋螺旋线开口互不连通，除此以外，其他相邻的左旋螺旋线的后端和右旋螺旋线的后端也由端部接头3-3连通，保留的两个开口作为输入口和输出口，用于向螺旋线输入输出液体。本实施例中，前端是指进行手术操作的一端。
本公开实施例的自然腔道手术用可展变刚度蛇形载体的刚度的变化通过控制热量的输入输出改变热熔胶状态来实现，控制原理如图4所示。液泵4-2连接热介质源4-3和冷介质源4-4，并通过连接管连接至编织管4-1的编织线的入口，液泵4-2可将热介质源4-3或冷介质源4-4的热介质或冷介质注入到编织线的中空细管中，由于所有编织线构成一个通路，所以介质可以充满整个编织管。利用热传导，使热量在热熔胶和介质之间传递，改变热熔胶的状态进而改变其对编织丝(细管)约束的能力，最终实现整体结构变刚度的功能，介质传输完成后，通过编织线的出口将废介质回收至容器4-5。热熔胶的状态变化为：当通入热介质时，热熔胶变软呈现可塑黏稠状态，对编织线(细管)约束能力小，结构承受载荷能力差，结构呈现柔态；当通入冷介质时，热熔胶变硬呈现固态，对编织线(细管) 约束能力强，结构承受载荷能力强，结构呈现刚态。
自然腔道手术用可展变刚度蛇形载体的折展通过驱动丝控制，控制原理如图5所示。编织管可在外载荷下轻松的进行径向伸展，编织管初始状态为小直径状态，图5所示的驱动丝5-1沿交叉点列分布，其一端固定在编织管的端部接头，并依次交错穿过交叉点列的交叉点向后延伸。所述交错穿过是指在驱动丝与奇数交叉点的交叉处，驱动丝位于编织管外部，在驱动丝与偶数交叉点的交叉处，驱动丝位于编织管内部，或者相反的情况也可以。
编织管外壁还套有弹性橡胶环，同时拉伸两侧的驱动丝能够调节增大编织管的直径，取消丝拉力弹性橡胶环将编织管压成小直径状态。
本实施例中，驱动丝数量为3，且3根驱动丝以圆周阵列结构均匀布置，即在编织管周向间隔120°均匀布置，通过轴向拉伸3根驱动丝对编织管施加轴向力，结构变粗，呈现大直径状态；取消丝拉力，编织管依靠弹性橡胶环5-2的压力恢复到小直径状态。轴向拉伸一或两根驱动丝，编织管会发生弯曲。本公开并不以此为限，驱动丝数量可以多于3根。
自然腔道手术用可展变刚度蛇形载体可实现分段变刚度以便进行弯曲控制。在编织管的不同区域采用软化温度不同的热熔胶，当通入的热水介于两种不同材料的软化温度之间时，可实现结构局部变刚度。在蛇形载体后端涂覆高软化温度材料，在前端涂覆低软化温度材料，当通入的水温度在两软化温度之间时，可实现后端刚度高，前端刚度低。整体刚度一致时，蛇形载体弯曲形式如图6所示；分段变刚度时，蛇形载体弯曲形式如图7所示，图中未弯曲部分为涂覆高软化温度材料段，弯曲部分为涂覆低软化温度材料。
可展可变刚度蛇形载体可根据特殊需求采用其他初始形状的编织管，如锥形，如图8所示。也可以截面形状为其他形状，如椭圆形，如图9所不。
编织管结构有多种编织方式，包括普通编织，钻石编织和三轴编织。
合理布置变刚度、变直径的顺序，可实现变刚度及变直径的耦合，将折展方法与变刚度方法进行综合。
本公开第二实施例提供一种将可展变刚度蛇形载体用于自然腔道手 术的方法，用于上述的自然腔道手术用可展变刚度蛇形载体，如图10为本公开实施例的将可展变刚度蛇形载体用于自然腔道手术的方法流程图，如图10所示，包括以下步骤：
步骤S1：向编织线内通入热介质，编织管呈现柔态、小直径状态。
当编织线通入热介质，热熔胶为粘稠状，编织管的状态为柔态、小直径状态。
步骤S2：将编织管伸入自然腔道。
编织管在在进入人体过程中呈现小直径、柔态，进入过程不会给人体造成明显不适感。
步骤S3：增大编织管直径，并向编织线内通入冷介质，编织管呈现刚态、大直径状态。
步骤S3包括以下子步骤：
子步骤S31：拉伸驱动丝使编织管直径增大；
子步骤S32：保持拉力，向编织线内通入冷介质，热熔胶凝固后取消拉力，编织管呈现刚态、大直径状态。
步骤S4：编织管内通入手术工具进行手术操作。
图11为本公开实施例的自然腔道手术用折展变刚度蛇形载体在NOTES机器人整机中的使用示意图。11-1为手术工具，全部手术工具通过本公开的可展变刚度蛇形载体11-2进入人体内部进行手术操作。蛇形载体11-2在手术工具进入人体时可以起到隔离工具保护组织作用，手术操作时起到多工具支撑的作用。
步骤S5：手术后向编织线内通入热介质，编织管恢复到柔态、小直径状态，将编织管撤出自然腔道。
步骤S5包括以下子步骤：
子步骤S51：手术后向编织线内通入热介质；
子步骤S52：弹性橡胶环对编织管施加径向压力，编织管恢复到柔态、小直径状态；
子步骤S53：将编织管撤出自然腔道。
由上述实施例可以看出，本公开的自然腔道手术用可展变刚度蛇形载体，具有良好的柔性，可实现大曲率弯折，适应复杂人体腔道环境能力更 强；在进入人体后通过驱动丝撑起，呈现大直径状态，撑开人体组织，提供更大的腔道通路；呈现大直径后通过控制热量输入输出可呈现刚态，可保护人体腔道免受手术器械的戳伤、刮伤，并为手术器械提供支撑，提高稳定性，提升手术精度；可通过选用软化温度不同的热熔胶而实现变刚度位置可控，实现蛇形载体刚度分段可控，更满足手术操作实际需求；在进入人体过程中呈现小直径、柔态，进入过程不会给人体造成明显不适感；手术后通过控制热量输入输出，蛇形载体可呈现小直径、柔态，方便撤出。
以上所述的具体实施例，对本公开的目的、技术方案和有益效果进行了进一步详细说明，应理解的是，以上所述仅为本公开的具体实施例而已，并不用于限制本公开，凡在本公开的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本公开的保护范围之内。

Claims (10)

  1. 一种自然腔道手术用可展变刚度蛇形载体，包括编织管，所述编织管由多根编织线螺旋缠绕交叉而成；所述编织线为中空管状结构。
  2. 如权利要求1所述的自然腔道手术用可展变刚度蛇形载体，其中，还包括热熔胶，所述热熔胶涂覆在编织线的交叉节点处；
    所述热熔胶的硬度随温度变化，所述编织管的刚度随热熔胶硬度的变化而变化。
  3. 如权利要求2所述的自然腔道手术用可展变刚度蛇形载体，其中，所述编织线内部通有介质，所述介质在编织线内传输，利用热传导使热量在介质与所述热熔胶之间传递。
  4. 如权利要求3所述的自然腔道手术用可展变刚度蛇形载体，其中，
    编织线包括多根顺序排列的左旋螺旋线及右旋螺旋线，左旋螺旋线与右旋螺旋线交叉缠绕形成编织管；
    左旋螺旋线与右旋螺旋线两端设置有端部接头，用于将左旋螺旋线与右旋螺旋线连接为通路。
  5. 如权利要求4所述的自然腔道手术用可展变刚度蛇形载体，其中，
    在编织管的前端，左旋螺旋线的前端和右旋螺旋线的前端由端部接头连通；
    在编织管的后端，其中一个左旋螺旋线和一个右旋螺旋线的开口互不连通，作为编织线的输入口和输出口，用于向编织线内输入输出液体，其他左旋螺旋线的后端和右旋螺旋线的后端由端部接头连通。
  6. 如权利要求2所述的自然腔道手术用可展变刚度蛇形载体，其中，
    所述热熔胶采用至少两种软化温度不同的热熔胶，分别涂覆于所述编织管的不同区域，用于实现局部区域变刚度；和/或
    所述热熔胶表面涂有乳胶，用于限制热熔胶的位置，防止热熔胶相互粘连。
  7. 如权利要求1所述的自然腔道手术用可展变刚度蛇形载体，其中，还包括：
    驱动丝，用于对编织管施加轴向力，调节编织管的直径和弯曲程度； 和/或
    弹性橡胶环，套设在编织管外周，用于对编织管施加径向力，使编织管由大直径恢复到小直径状态。
  8. 如权利要求7所述的自然腔道手术用可展变刚度蛇形载体，其中，所述驱动丝前端与编织管前端连接，并沿轴向穿过交叉节点向后延伸，通过拉伸驱动丝后端，增大编织管的直径。
  9. 一种将权利要求1至8中任一项所述的可展变刚度蛇形载体用于自然腔道手术的方法，包括以下步骤：
    S1：向编织线内通入热介质，编织管呈现柔态、小直径状态；
    S2：将编织管伸入自然腔道；
    S3：增大编织管直径，并向编织线内通入冷介质，编织管呈现刚态、大直径状态；
    S4：编织管内通入手术工具进行手术操作；
    S5：手术后向编织线内通入热介质，编织管恢复到柔态、小直径状态，将编织管撤出自然腔道。
  10. 如权利要求9所述的将可展变刚度蛇形载体用于自然腔道手术的方法，其中，
    步骤S3包括：
    S31：拉伸驱动丝使编织管直径增大；
    S32：保持拉力，向编织线内通入冷介质，热熔胶凝固后取消拉力，编织管呈现刚态、大直径状态；
    步骤S5包括：
    S51：手术后向编织线内通入热介质；
    S52：弹性橡胶环对编织管施加径向压力，编织管恢复到柔态、小直径状态；
    S53：将编织管撤出自然腔道。
PCT/CN2018/088647 2017-07-17 2018-05-28 一种自然腔道手术用可展变刚度蛇形载体及其应用方法 Ceased WO2019015400A1 (zh)

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CN107198576B (zh) * 2017-07-17 2020-03-03 天津大学 一种自然腔道手术用可展变刚度蛇形载体
CN108527411B (zh) * 2018-04-10 2021-02-05 南京晨光集团有限责任公司 一种可变刚度的柔性机械手
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CN116035507B (zh) * 2023-02-02 2026-02-27 中国海洋大学 一种可变刚度载体及其系统
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