WO2021063024A1 - 一种用于组织切除的圈套器 - Google Patents

一种用于组织切除的圈套器 Download PDF

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Publication number
WO2021063024A1
WO2021063024A1 PCT/CN2020/095273 CN2020095273W WO2021063024A1 WO 2021063024 A1 WO2021063024 A1 WO 2021063024A1 CN 2020095273 W CN2020095273 W CN 2020095273W WO 2021063024 A1 WO2021063024 A1 WO 2021063024A1
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Prior art keywords
ferrule
snare
flat wire
wire structure
longitudinal axis
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PCT/CN2020/095273
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English (en)
French (fr)
Inventor
韦建宇
沈正华
李常青
金鸿雁
汤小伟
冯明浩
奚杰峰
唐志
李宁
刘春俊
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Micro Tech Nanjing Co Ltd
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Micro Tech Nanjing Co Ltd
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Publication of WO2021063024A1 publication Critical patent/WO2021063024A1/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32056—Surgical snare instruments

Definitions

  • This application relates to the field of medical devices, and in particular to a snare for tissue resection.
  • Endoscopic mucosal resection refers to the injection of drugs into the submucosal layer of the lesion (such as sessile polyps, flat or shallow concave polyps, leiomyomas, early cancers of the esophagus, stomach and colon, etc.) to form a liquid cushion and then cut out Techniques for large pieces of mucosal tissue.
  • drugs such as sessile polyps, flat or shallow concave polyps, leiomyomas, early cancers of the esophagus, stomach and colon, etc.
  • polyps can be divided into three types according to their shape: Guangji sessile polyps, Yati polyps and pedicle polyps.
  • the pedicle means the root.
  • Polyps with pedicles are relatively slender polyps. Polyps with pedicles are generally benign; sessile is without obvious roots, and the shape is relatively flat. Generally speaking, malignant polyps are more common; polyps with pedicles are more common. Between the two, it is raised but the root is relatively inconspicuous.
  • the traditional snare ferrule material is woven from multiple strands of stainless steel round wire. The ferrule material is soft and has poor resistance to deformation.
  • snare specifications include seven models including 40mm, 35mm, 30mm, 25mm, 20mm, 15mm and 10mm. Due to the limitation of traditional snare ferrule structure, the diameter of the ferrule (the maximum distance between the two sides of the axial symmetry of the ferrule) rapidly becomes smaller during the process of shrinking the ferrule to the outer tube, and loses the original shape and cannot maintain the original shape under different diameters. The shape of the ferrule is used to trap polyps, which can only be trapped in the original size.
  • the doctor usually needs to predict the size of the patient's lesion first, and then use different sizes of snares to perform EMR surgery under the endoscope. However, during the actual operation, the doctor may misjudge the size of the lesion. It is also possible that after the first polyp (or other lesions) is removed, new polyps are found when the examination is continued, and the diameter is quite different from the previous one. , There is a defect that the same snare cannot be used for polyps or lesions of different diameters, so that doctors have to replace the snare with a new specification, which increases the operation time and the economic burden of the patient is also greatly increased.
  • the purpose of this application is to: in view of the low stiffness of the ferrule in the prior art, the sessile or pedicle polyp cannot be effectively inserted into the snare, and its edge cannot be completely grasped, so that the lesion cannot be completely removed at one time.
  • the performance of taking sessile or yati polyps is poor, and the same snare cannot meet the defects of removing polyps or lesions of different diameters. It provides a snare that has good tissue grasping performance and can continuously reduce diameters and snare lesions of different diameters. Snare.
  • a hollow outer tube with a proximal end and a distal end a cable located in the outer tube and capable of reciprocating along its longitudinal axis; a ferrule arranged at the distal end of the cable, passing along the Move the cable in the longitudinal direction to pull the ferrule into or out of the outer tube, thereby changing the inner snare area of the ferrule; configured to fix the proximal end of the ferrule and the distal end of the cable
  • the fixed portion of the connection; the ferrule is a single-strand flat wire structure, the cross-sectional thickness P of the flat wire structure and the height Q ratio are 1:4 to 1:1.5, wherein the ferrule is axially along the longitudinal axis Symmetrical, and strong bending parts are axially opposite to each other on both sides of the ferrule axial direction, and the strong bending parts are preferably symmetrically arranged.
  • the invention adopts the special design of single-strand flat wire structure and the ratio of thickness P to height Q in the ferrule flat wire structure is controlled in the range of 1:4 ⁇ 1:1.5, which is easier than traditional multi-strand winding wire ferrule.
  • the defect of deformation, the single-strand flat wire structure has stronger resistance to deformation, and can withstand greater force in the height direction of the flat wire without deforming, so that it is easier to press the edge of the polyp tissue and effectively invade the tissue completely into the snare , Improve the efficiency of crawling organization.
  • the strong bending portion is formed by pre-bending the ferrule flat wire structure, and the flat wire structure at the strong bending portion has a strength enhancement structure.
  • the strong bending portion is formed by bending the ferrule flat wire structure to a certain angle in the same plane in opposite directions and then strengthening the bending part to form a strength-enhancing structure.
  • the strength-enhancing structure includes a reinforced coating and a reinforced coating.
  • the material can be reinforced solder and/or reinforced coating.
  • the strength-reinforcing structure in this application may not contain reinforced coating and is formed only by reinforced bending treatment, but by using reinforced coating, such as reinforced solder, reinforced coating , Can improve the deformation resistance of the strong bending part, and improve the technical effect of the overall diameter reduction of the snare without deformation.
  • the ferrule in the present application is based on the bending characteristics of the strong bending part during the recovery process, which slows down the shape of the ferrule in the recovery process and quickly considers the central axis Therefore, the effect of reducing diameter and not deforming is basically realized.
  • the strong bending structure obtained by bending the flat wire in the same plane in opposite directions in the present application guarantees the maximum guarantee in the process of recycling the ferrule
  • the middle bending position and shape are relatively stable, and the overall shape of the ferrule basically maintains the shape of the racket.
  • the ratio of the axial distance d1 of the strong bending part from the distal end to the length L2 of the ferrule along the longitudinal axis is less than 1/2, wherein the axial distance d1 of the strong bending part from the distal end is the strong bending part
  • the length between the axial projection position of the ferrule and the farthest end of the ferrule, the length of the ferrule extending along the longitudinal axis, the value L2 is the distance between the farthest end of the ferrule and the farthest end of the outer tube.
  • the strong bending part When the axial distance d1 of the strong bending part from the distal end is equal to the length of the ferrule extending along the longitudinal axis L2 When the ratio is less than 1/2, or even smaller, the effect of diameter reduction without deformation is the best, and the ability to grasp polyps is the strongest. When 1/6 ⁇ d1/L2 ⁇ 1/2, the strong bending part has the strongest ability to slow down the deformation of the ferrule.
  • the ratio of the ferrule diameter L1 of the snare to the length L2 of the ferrule along the longitudinal axis is 1:4 to 1:1.5, wherein the ferrule diameter L1 of the snare is equal to that of the ferrule.
  • the maximum distance between the two sides of the ring is axially symmetric, and the extension distance of the ring along the longitudinal axis L2 is the distance between the farthest end of the ring and the farthest end of the outer tube.
  • the ferrule When the snare cuts the tissue, the ferrule is pulled into the outer tube from the distal end to the proximal end. When the ferrule continuously enters the outer tube, the diameter of the snare gradually becomes smaller, and the ratio of L1 to L2 gradually changes. Before the middle and ferrule entraps the tissue, based on the bending characteristics of the strong bending part in the ferrule, it can be realized that the shape of the ferrule is basically maintained as a racket-like shape during the continuous change of the diameter of the ferrule, so that the diameter of the ferrule is not deformed. the goal of.
  • the ferrule does not have a bendable and strong bending part, when the ferrule is recovered to the outer tube, when the symmetrical two sides of the ferrule are compressed by the outer tube, the two sides of the ferrule are integrated toward the longitudinal axis. The direction is folded and closed quickly, resulting in the ferrule not having enough time to fully adjust and grasp the polyp tissue, resulting in poor tissue grasping ability of the ferrule.
  • the ratio of L1 to L2 is 1:3 to 1:2.34, and the numerical range of L1 is 10 mm to 40 mm.
  • the flat wire structures on both sides of the ferrule that are axially symmetric have at least an arc-shaped flat wire structure and a straight-line flat wire structure, respectively, and the strong bending portion is located at the flat wire structure of the arc-shaped section flattened toward the straight line. The transition position of the silk structure.
  • the ratio of the cross-sectional thickness P and the height Q of the ferrule flat wire structure is 1:3 to 1:2.
  • cross section of the flat wire structure is rectangular or a fan ring with an opening facing the longitudinal axis of the ferrule.
  • the overall structure of the ferrule is similar to the I-steel structure, which can withstand greater force in the vertical direction of the ferrule plane and is not easy to deform, thereby providing greater holding force for better It is easy to compress the polyp tissue and effectively nest the tissue into the ferrule.
  • the cross-sectional shape of the flat wire structure is a fan ring with an opening facing the longitudinal axis of the ferrule (similar to a C-shape)
  • the arc-shaped opening facing the inner side of the ferrule is easier to fasten and grasp the polyp tissue in the ferrule, and due to the height of the flat wire
  • the upper and lower ends of the direction are curved surfaces, so that the ferrule is adapted to the curvature of the inner wall of the outer tube.
  • the fixing part is a riveting pipe arranged outside the fixed connection end of the ferrule and the cable and located inside the outer pipe.
  • the ferrule is shaped by medical stainless steel, nickel-titanium alloy and cobalt-chromium alloy.
  • This application optimizes the structure of the ferrule wire material to make it easier for doctors to press the polyp through this structure in the clinic, and to completely lift the polyp, especially for flat pedicle or pedicle polyps, it is easier to complete the lesion and Thoroughly nest in the snare, so as to ensure that the polyp is removed more thoroughly.
  • the racquet-like snare for tissue removal realizes the technical effect of adjustable ring diameter gear by providing a strong bending part structure on the ring.
  • the supporting function of the strong bending part in the ferrule is better, and the shape change is flexible.
  • the shape of the ferrule will not change due to the change of the diameter of the ferrule during the tissue removal process.
  • the shape of the ferrule is always similar to the shape of a racket, so it is suitable for lesions of different diameters.
  • the position of the two ends of the flat wire structure of the ferrule in the height direction is basically the same as the relative position outside the outer tube, and the two sides of the ferrule are placed in parallel.
  • the sum of the thickness of the flat wires on both sides is less than the diameter of the outer tube.
  • Figure 1 shows a schematic diagram of the structure of the ferrule in different gears
  • Figure 2 shows a schematic diagram of the distal end of a snare with a tail silver solder joint and a riveted tube on the ferrule;
  • FIG. 3 shows a schematic diagram of the structure of the strong bending part 5 in the ferrule
  • Figure 4 shows a schematic diagram of the ferrule marked with positions L1 and L2;
  • Figure 5 shows a three-dimensional schematic diagram of a flat wire structure with a rectangular cross-section
  • Figure 6 shows the thickness and height markings in the flat wire structure with a rectangular cross-section
  • Figure 7 shows a three-dimensional schematic diagram of a flat wire structure with a fan ring in cross section
  • Figure 8 shows the thickness and height markings in the flat wire structure with an arc-shaped cross-section
  • Figure 9 shows a schematic diagram of the maximum stroke of the handle
  • Figure 10 shows the tooling diagram of the pressure test of the snare ferrule
  • Figure 11 shows a cross-sectional view of a 3*3 multi-strand braided wire in the prior art
  • Fig. 12 shows a cross-sectional view of a 1*7 multi-strand braided wire in the prior art.
  • the working process of the snare in this application as shown in Figure 1, Figure 2 and Figure 9, first select a snare with an appropriate length of the outer tube according to the patient’s lesion site, and then place the snare into the working channel of the endoscope and make the snare
  • the distal end of the outer tube (the distal end refers to the end opposite to the external operating end and located inside the human body) is placed on the lesion site.
  • the control slider 8 on the snare handle 7 is adjusted ( Figure 9) Show) Adjust the diameter of the ferrule 1 of the snare to be slightly larger than the diameter of the polyp, then put the ferrule 1 of the snare on the pedicle of the lesion, and ensure that the lateral plane of the ferrule 1 is approximately parallel to the lateral plane of the lesion.
  • the control slider 8 fixedly connected to the cable 4 on the sliding handle 7 is used to pull the cable 4 toward the proximal end, and the cable 4 drives the ferrule 1 to retract into the outer tube 6.
  • the diameter of the ferrule 1 becomes smaller, but the shape of the racket of the ferrule 1 remains basically unchanged.
  • the polyp is tightened, and the polyp protrudes on the ferrule 1.
  • the high-frequency current of the active device (not shown in the figure) connected to the snare is turned on, and the polyp is cut off under the action of the high-frequency current. If the patient needs to continue to remove polyps or lesions of other diameters, slide the slider 8 on the handle 7 to drive the cable to change the diameter of the snare loop, place the loop 1 on the new lesion to be cut, and continue. Tissue cutting without having to replace new snares of other specifications.
  • the strong bending portion 5 is formed by bending a flat wire structure of the ferrule 1 to a certain angle in the same plane, and then strengthening the bending part to form a strengthening structure, and the strength strengthening structure is reinforced solder and/ Or reinforced coating layer, the flat wire structures on both sides of the axial symmetry of the ferrule 1 respectively have at least an arc-shaped flat wire structure and a straight-line flat wire structure, and the strong bending portion 5 is located in the arc-shaped flat wire structure. The transition position of the wire structure to the straight-line flat wire structure.
  • the preferred structure of the present application is that the straight section at the proximal end of the ferrule, the arc section at the distal end of the ferrule, the proximal end of the straight section and the distal end of the arc section are fixedly connected And form a strong bending part that can be bent.
  • the snare configured for tissue resection includes at least the following structure: a hollow outer tube 6 having a proximal end and a distal end; Pull cord 4; a ferrule 1 arranged at the distal end of the pull cord 4, by moving the pull cord 4 along the longitudinal axis to pull the ferrule 1 into or out of the outer tube 6, thereby changing the
  • the inner snare area of the ferrule 1 is provided at the distal end of the cable with a fixing portion configured to fixedly connect the proximal end of the ferrule 1 and the distal end of the cable 4, and the fixing portion is preferably arranged on the ferrule 1
  • the riveting pipe 3 outside the joint end of the cable 4 and located inside the outer tube 6, can also adopt other existing conventional fixed connection means such as welding.
  • a ferrule is provided at the distal end of the fixed part formed by the ferrule 1 and the cable 4
  • the tail silver solder joint 2 is configured to pre-fix the flat wire structure on both sides of the ferrule axially symmetrical.
  • other conventional fixed connection methods in the prior art can also be used.
  • the flat wires on both sides of the end are pre-fixed, and then the flat wires on both sides of the ferrule 1 are fixedly connected to the cable 4, which improves the deformation resistance of the proximal end of the ferrule and can provide the bending process of the strong bending part on the ferrule. Sufficient supporting force to better realize the technical effect of diameter reduction and non-deformation of the ferrule.
  • the ferrule 1 is a single-strand flat wire structure, the ratio of the thickness P to the height Q of the flat wire structure is 1:1.5 to 1:4, and the ferrule 1 is axially symmetrical along the longitudinal axis, and The two sides of the ferrule that are axially symmetric are respectively provided with strong bending parts.
  • the ferrule 1 is preferably shaped by one or more of stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. Of course, other materials that can be used in the body in the prior art can be used.
  • the overall rigidity of the ferrule of the single-strand flat wire structure is far greater than that of the traditional ferrule structure composed of multiple round wires.
  • the traditional ferrule is usually woven from multiple round wires and adopts 3*3 (It is woven from three silk threads woven by three filaments respectively, see Figure 11 for details) or 1*7 (a silk thread woven from a central filament and six filaments surrounding the central filament, specifically See Figure 12) Braiding specifications, the total outer diameter is controlled within 0.4mm, for example, a 1*7 specification multi-strand ferrule is woven from 7 round wires, and the diameter of each round wire is about 0.16mm. The diameter is small, and the corresponding deformation resistance is relatively small.
  • the cross-sectional height of the single-stranded flat wire ferrule wire is 0.18-0.48mm, and the thickness of the flat wire section is about 0.12-0.2mm.
  • the cross-section of the ferrule wire is preferred.
  • the thickness is about 0.2mm, and when the height is about 0.381mm, the thickness is about 0.127mm.
  • the single-strand flat wire structure adopted in this application has better resistance to deformation and can provide stronger gripping power to the lesion tissue.
  • the cross-section of the flat wire structure can be rectangular.
  • the overall structure of the ferrule is similar to the I-steel structure, which can withstand more in the vertical direction of the ferrule plane.
  • the large force is not easy to deform, which can provide a greater holding force, so that it is easier to press the polyp tissue, and the tissue is effectively inserted into the snare.
  • the cross section of the flat wire structure may be a fan ring with an opening facing the longitudinal axis of the ferrule.
  • the cross section of the flat wire structure is a fan ring with an opening facing the longitudinal axis of the ferrule (similar to C )
  • the arc-shaped opening facing the inner side of the ferrule makes it easier to clasp the polyp tissue in the ferrule, and because the upper and lower ends of the flat wire in the height direction are arc-shaped curved surfaces, the ferrule is adapted to the curvature of the inner wall of the outer tube , When the ferrule slides back and forth in the outer tube, the smoothness is greatly improved.
  • FIG. 10 it is a schematic diagram of the tooling for pressure test of the snare ferrule wire.
  • One end of the ferrule wire structure to be tested is fixed to the fixed tooling structure, and the other free end is used as the test point.
  • the distance between the test point and the fixed point of the tooling It is 20mm.
  • the free end of the ferrule wire deformed to reach a certain pressure distance is recorded, and the pressure required to be applied to the free end is recorded.
  • Table 1 is a list of the different parameters of the flat wire structure ferrule and the existing 1*7 specification ferrule, and the parameter comparison table of the corresponding strength percentage of the different specification ferrule.
  • the abscissa values in the first 6 rows and 5 columns in Table 1 represent the ratio of the thickness P to the height Q of the flat wire section, which are 1:1.5, 1:2, 1:3, and 1:4 (the corresponding specific size examples are 0.12mm/0.18mm, 0.20mm/0.40mm, 0.127mm/0.381mm and 0.12mm/0.48mm), the ordinate value represents the compression distance of the free end of the ferrule when the pressure is tested (the ferrule is perpendicular to the thickness direction) Back deflection distance), the two-dimensional value of the intersection area between the abscissa and the ordinate refers to the pressure (in N) required for the free end of the ferrule corresponding to the PQ value to deviate from 2mm, 4mm... and 10mm, the same pressure Distance, the larger the pressure value, the better the holding performance of the snare made of ferrule wire of this size.
  • the sixth column in the table is the finished product of 1*7 specification ferrule (the part where the end of the snare covers the polyp) which is woven with 7 round wires in the prior art.
  • the total outer diameter of the ferrule wire section is about 0.4mm;
  • the specific meaning of the 6 columns is that when the pressure test of the existing multi-strand round wire ferrule is performed, when the compression distance of the ferrule wire (the deflection distance perpendicular to the length direction) is 2mm, 4mm, 6mm, 8mm and 10mm respectively, the free end deviates
  • the pressure required for 2mm, 4mm... and 10mm is respectively 0.04N, 0.07N, 0.10N, 0.12N and 0.17N.
  • the pressure applied is 0.17N as the reference force value, and the strength percentage is set to 100%, and the same free end deviates by 10mm, and the different PQ size is flat.
  • the pressure to be applied to the wire is 0.15N, 1.05N, 0.30N and 1.10N.
  • the strength percentage of the flat wire ferrule of different specifications is 88%. , 618%, 176% and 647%. It can be seen from this:
  • the P/Q value range of the flat wire cross-section is preferably greater than 1:4 and less than 1:1.5, and P and Q should satisfy 0.1mm ⁇ P ⁇ Q ⁇ 0.48mm.
  • the ferrule structure further includes a strong bending portion 5 arranged symmetrically along the longitudinal axis of the ferrule.
  • the maximum distance between the two sides of the axial symmetry of the ferrule is defined as the ferrule diameter L1 of the snare, and the distance between the most distal end of the ferrule and the most distal end of the outer tube is defined as the extension distance of the ferrule along the longitudinal axis.
  • the value L2 the ratio of L1 to L2 is preferably 1:1.5 to 1:4.
  • Table 2 and Table 3 are comparison tables of different parameters of L1 and L2 and L1/L2 in this application.
  • the abscissa in Table 2 is the ratio of L1 to L2, which are four specifications of 1:1.5, 1:2.34, 1:3 and 1:4 respectively.
  • the ordinate represents the value of the snare ferrule diameter L1; the cross area in the table
  • the two-dimensional data represents the value of L2 (in mm).
  • the abscissa represents the ratio of L1 to L2; the ordinate represents the value of the snare ferrule diameter L1; the intersecting two-dimensional value represents L3 (in mm), where L3 represents the maximum movable movement of the control slider 8 on the handle 7 Stroke (see Figure 9), L3 usually corresponds to the limit of the controllable size of a human finger.
  • the maximum stroke L3 that the slider can move is 240mm, which is relatively large (generally the longest does not exceed 120mm in actual use), which is not conducive to manual operation.
  • L1/L2 is preferably between 1:1.5 and 1:2.34.
  • L1/L2 should be between 1:2.34 and 1:4; snares with L1/L2 greater than 1:4 are not applicable in clinical practice.
  • the strong bending part 5 in the first embodiment or the second embodiment has an enhanced bending structure, which can basically maintain the bending inflection point during the deformation of the ferrule, thereby ensuring that the shape of the ferrule basically maintains the shape of the racket during the process of grasping the tissue. No change, to achieve the technical effect of reducing the diameter without deformation.
  • the strong bending portion 5 is formed by bending the ferrule flat wire structure to a certain angle in the same plane, and then strengthening the bending part to form a strength enhancement structure, wherein the strength enhancement structure is preferably reinforced solder or reinforced coating
  • the solder is preferably a non-breakable and flexible metal material, such as silver, to form a silver solder layer, so as to ensure that the strong bending portion 5 has sufficient bending stability and is not easy to break during the deformation process.
  • the existing conventional flat wire ferrule products without strong bending parts, a certain symmetrical flat wire ferrule product with torsion angle and the flat wire ferrules with strong bending parts in this application have been tested.
  • the change in the diameter of the ferrule during the retraction of the loop further proves that the ferrule in the present application basically realizes the beneficial effect of reducing the diameter and not deforming.
  • the slider on the handle moves to the proximal end to retract the ferrule.
  • the diameter of the ferrule in the three products is measured.
  • the comparison shows that the diameter of the ferrule in this application Compared with the other two products, the decreasing trend is significantly slower, especially when the slider moves a distance of 5-20mm, and this moving distance is an important node in the process of grasping the tissue by the corresponding ring.
  • the reduction of the speed of the ferrule diameter reduction can provide enough time and space for the ferrule to fully adjust and grasp the polyp tissue, which greatly improves the tissue grasping ability of the ferrule.
  • the ferrule in the present application is based on the bending characteristics of the strong bending part during the recovery process, which slows down the shape of the ferrule quickly to the center during the recovery process The tendency of the shafts to move closer, which basically realizes the effect of reducing the diameter and not deforming.
  • the strong bending structure obtained by bending the flat wire in the same plane in opposite directions in the present application guarantees the maximum guarantee in the process of recycling the ferrule
  • the middle bending position and shape are relatively stable, and the overall shape of the ring basically maintains the shape of the racket, which effectively improves the gripping ability of the ring.
  • the two sides of the ferrule that are axially symmetric include at least an arc-shaped flat wire structure and a straight-line flat wire structure, respectively, and the strong bending portion 5 is configured to form the two-segment flat wire structure.
  • the ends are fixedly connected and form a bendable structure, wherein any one of the two flat wire structures is a straight or arc-shaped section extending along the length of the flat wire.
  • the position of the strong bending part 5 is preferably It is the transition position from the straight section to the arc section.
  • the bending feature of the strong bending part can be used to ensure that when the ferrule enters the outer tube, the distance between the flat wires on the two sides of the axial symmetry of the ferrule does not quickly close, and the overall shape of the ferrule Basically maintain stability.
  • the distal end of the ferrule is a straight section and the proximal end is an arc section.
  • the transition area between the proximal end of the straight section and the distal end of the arc section constitutes a strong bending part. 5.
  • the ferrule structure is relatively simple, stable and reliable, and can realize that the ferrule shape is basically a racket shape during the process of grasping the tissue, achieving the technical effect of changing the diameter and not deforming during the process of grasping the tissue.
  • the ratio of the axial distance d1 (as shown in FIG. 4) between the strong bending portion from the distal end and the extension distance L2 of the ferrule along the longitudinal axis is less than 1/2.
  • the distal axial distance d1 is the length between the strong bending part in the axial projection position of the ferrule and the farthest end of the ferrule, and the length of the ferrule extending along the longitudinal axis is the distance L2 is the distance between the farthest end of the ferrule and the outer tube.
  • the axial distance d1 from the distal end of the strong bending part to the ferrule extends along the longitudinal axis.
  • the ratio of the distance value L2 is less than 1/2, or even smaller, the effect of changing the diameter without deformation is the best, and then the ability to grasp the polyp is the strongest.
  • This embodiment illustrates the difference in the effect of reducing the diameter of the ferrule without deforming under different d1/L2.
  • the anti-deformation performance is correspondingly weakened.
  • the strong bending part has the strongest ability to slow down the deformation of the ferrule.
  • the ferrule is provided with a scale, and a laser is used to mark the side of the flat wire as a measurement scale, so that the doctor can better compare the size of the polyp or lesion under the endoscope and accurately estimate The size of the lesion, using a video screenshot to accurately save the size of the polyp, provide original and accurate data for future precise treatment.
  • the scale on the snare can help the doctor estimate the size of the lesion, so that the doctor can accurately determine the volume of the lesion and avoid judgment errors.
  • the height of the ferrule flat wire structure is 0.38mm and the thickness is 0.13mm.
  • the total thickness of the flat wire is 0.26mm
  • the cable diameter is 0.8mm
  • the inner diameter of the outer tube is 1.5mm. According to this parameter, the ferrule is easy to be pulled in the outer tube for reciprocating motion after being folded.
  • the positions of the two ends in the height direction of the ferrule flat wire structure are basically the same as the relative position outside the outer tube.
  • the two sides of the ferrule are placed in parallel, and the two sides of the ferrule are flat.
  • the sum of the thickness of the wire is smaller than the diameter of the outer tube.
  • the present application realizes snares with a ferrule diameter L1 ranging from 10mm to 40mm by providing a strong bending part.
  • the minimum scale of each size of snare is 5mm or 10mm. It can completely meet the requirement of the same specification snare to excise polyps of different diameters.
  • the ferrule diameter L1 of the ferrule refers to the maximum distance between the two sides of the axial symmetry of the ferrule.
  • the size of the snare provided is 40mm.
  • the snare can be adjusted before the polyp is trapped. Perform pre-operation and change its ferrule diameter L1 to 30mm. At this time, the snare still maintains the original racket shape. Then, the snare loop in this state is placed around the polyp, and then the diameter of the loop is reduced at this time to complete the process of grasping the polyp tissue.

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Abstract

一种用于组织切除的圈套器，具有近端和远端的中空外管（6），位于外管（6）中且可沿纵轴方向往复移动的拉索（4），设置于拉索（4）远端的套圈（1），套圈（1）为单股扁丝结构，扁丝结构的截面厚度P与高度Q比为1:4～1:1.5，其中，套圈（1）沿纵轴方向轴向对称，且在套圈（1）轴向两侧轴向相对设有强固弯折部（5）。可以有效将无蒂或亚蒂息肉完全套入圈套（1）内且基本实现变径不变形的技术效果，大大提高套圈（1）抓取相对扁平息肉的效果。

Description

一种用于组织切除的圈套器
相关申请的交叉引用
本申请要求于2019年09月30日提交中国专利局的申请号为CN201910941305.5、名称为“一种用于组织切除的圈套器”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械领域，尤其是涉及一种用于组织切除的圈套器。
背景技术
内镜下粘膜切除术(EMR)是指于病灶(如无蒂息肉、平坦或浅凹陷型息肉、平滑肌瘤、食管、胃和结肠早期癌等)粘膜下层内注射药物，形成液体垫后切取大块粘膜组织的技术。其优点是不用开刀手术，在内镜下即可将病灶切除。
临床上息肉按形状可分为：广基无蒂息肉、亚蒂息肉和有蒂息肉三种。蒂就是根的意思，有蒂的就是比较细长息肉，有蒂息肉一般来说良性多见；无蒂就是没有明显的根，形态较为扁平，一般来说恶性的较为多见；亚蒂息肉形态介于两者之间，隆起但根蒂相对不明显。传统圈套器套圈材料是由多股不锈钢圆丝编织而成，套圈材料柔软,抗形变性能较差，切割有蒂息肉时比较有优势，但在切割无蒂或亚蒂息肉时，因套圈过软，无法有效将无蒂或亚蒂息肉完全套入圈套内，不能将其边缘完全抓取，从而不能一次完整切除病变，抓取无蒂或亚蒂息肉性能差。
传统的电圈套器切除息肉过程中，往往需要根据患者病灶大小不同，使用不同规格的圈套器，常用的圈套器规格包括40mm，35mm，30mm，25mm，20mm，15mm以及10mm等七种型号。基于传统圈套器套圈结构限制,套圈在收缩至外管过程中，套圈直径(套圈轴向对称两侧的最大间距)迅速变小，而失去原始形状，不能在不同直径下保持原始套圈形状以套取息肉，只能在原始尺寸下进行套取息肉。医生在手术过程中通常需要先对患者病灶大小进行预判，再选用不同规格大小的圈套器在内镜下进行EMR手术。但实际操作过程中，医生有可能对病灶大小发生错误预判的情况，也有可能切除第一个息肉(或其他病灶)后，再继续检查时发现新的息肉，并且直径与之前的区别较大，存在同一个圈套器不能满足多种不同直径息肉或病灶使用的缺陷，使得医生不得不更换新规格的圈套器，增加了手术时间，同时患者经济负担也大大增加。
发明内容
本申请的目的在于：针对现有技术中存在的套圈刚度较低，无法有效将无蒂或亚蒂息肉完全套入圈套内，不能将其边缘完全抓取，从而不能一次完整切除病变，抓取无蒂或亚蒂息肉性能差,且同一个圈套器不能满足切除不同直径息肉或病灶的缺陷，提供一种套圈抓取组织性能好，且具有可连续变径，套取不同直径病灶的圈套器。
为了实现上述目的，提供一种用于组织切除的圈套器：
至少包括如下结构：具有近端和远端的中空外管；位于所述外管中，且可沿其纵轴方向往复移动的拉索；设置于所述拉索远端的套圈，通过沿纵轴方向移动所述拉索以将所述套圈拉入或推出所述外管，进而改变所述套圈内部圈套面积；配置成将所述套圈近端与所述拉索远端固定连接的固定部；所述套圈为单股扁丝结构，所述扁丝结构的截面厚度P与高度Q比为1:4～1:1.5，其中，所述套圈沿纵轴方向轴向对称，且在所述套圈轴向两侧轴向相对设有强固弯折部，强固弯折部优选为对称设置。
发明通过采用单股扁丝结构且将套圈扁丝结构中厚度P与高度Q比控制在1:4～1:1.5这一范围内这一特殊设计，相对于传统多股缠绕丝线套圈易形变这一缺陷，单股扁丝结构抗形变能力更强，在扁丝高度方向上也能够承受更大的力而不变形，从而更容易压住息肉组织边缘，有效将组织完全套入圈套内，提高抓取组织的效率。通过大量临床试验发现，当扁丝的P/Q的值小于1:4时，圈套器不够锋利，切割息肉时医生感觉阻力大；当扁丝的P/Q的值大于1:1.5时，扁丝结构中厚度P相对于高度Q过大，高度方向上承受力的抗形变性能大幅降低，导致切割息肉力量不够，此外，当扁丝高度值过大时，进出外管阻力大。
进一步，所述强固弯折部由套圈扁丝结构预弯形成且在所述强固弯折部处的扁丝结构具有强度增强结构。
进一步，所述强固弯折部由套圈扁丝结构在同一平面内对向弯折一定角度后通过对折弯处进行增强处理后形成强度增强结构，所述强度增强结构包括增强覆料，增强覆料可以为增强焊料和/或增强包覆层，当然本申请中强度增强结构可以不包含增强覆料，仅通过强化折弯处理形成，而通过采用增强覆料，如增强焊料，增强包覆层，可以提高强固弯折部的抗形变性能，提高圈套器整体变径不变形的技术效果。相比于现有不具备强固弯折部的套圈结构，本申请中的套圈在回收过程中基于该强固弯折部的折弯特性，减缓套圈在回收过程中形态迅速向中心轴考虑的趋势，从而基本实现了变径不变形的效果。相比于现有技术中不设置强固弯折部或者扁丝扭转弯折结构，本申请中将扁丝在同一平面内对向弯折获 得的强固弯折结构最大限度的确保在回收套圈过程中折弯位置和形态相对稳定，套圈整体形态基本维持球拍形状。
进一步，强固弯折部距远端轴向距离d1与套圈沿纵轴方向伸出距离值L2的比值小于1/2，其中，强固弯折部距远端轴向距离d1为强固弯折部在套圈轴向投影位置与套圈最远端间的长度，套圈沿纵轴方向伸出距离值L2为套圈最远端与外管最远端间距离。通过不断反复试验和优化，研发人员发现强固弯折部的设置位置影响变径不变形的效果，当强固弯折部距远端轴向距离d1与套圈沿纵轴方向伸出距离值L2的比值小于1/2，甚至更小值时变径不变形效果最佳，进而抓握息肉能力最强。当1/6<d1/L2<1/2时，强固弯折部的减缓套圈形变能力最强。
进一步，所述圈套器的套圈直径L1与套圈沿纵轴方向伸出距离值L2的比值为1:4～1:1.5，其中，所述套圈器的套圈直径L1为所述套圈轴向对称的两侧最大间距，套圈沿纵轴方向伸出距离值L2为套圈最远端与外管最远端间距离。
在圈套器切除组织时，套圈由远端向近端被拉入外管中，当套圈不断进入外管中时，圈套器的套圈直径逐渐变小，在L1与L2的比值渐变过程中且套圈套住组织前，基于套圈中强固弯折部具有折弯特性，从而可以实现套圈直径不断变化的过程中，套圈形状基本保持为类似球拍状的形状，达到变径不变形的目的。现有技术中，由于套圈不具备可折弯强固弯折部，故在套圈回收至外管的过程中，套圈对称的两侧边受外管压迫时，两侧边整体向纵轴方向收拢，并快速闭合，导致套圈不具有足够的时间来充分调整并抓取息肉组织，导致套圈的抓握组织能力较差。而本申请中通过在套圈上设置特殊的强固弯折部结构，实现在抓取组织过程中，套圈两侧边收拢速度减缓，给调整组织抓取过程留下足够的时间和空间，使得抓握组织过程更加容易且灵活；同时，由于设置可折弯的强固弯折部，使得套圈在使用过程中，基本实现变径不变形的技术效果，相对于现有技术中，对于不同尺寸息肉，需要使用不同型号圈套器的技术缺陷，本申请实现了同一圈套器可以实现不同尺寸息肉组织抓取的目的，节约了治疗的时间成本和经济成本。
进一步，L1与L2的比值为1:3～1:2.34，L1的数值范围为10mm～40mm。
进一步，所述套圈轴向对称的两侧扁丝结构分别至少具有一弧形段扁丝结构和一直线段扁丝结构，所述强固弯折部位于所述弧形段扁丝结构向直线段扁丝结构过渡位置。
进一步，所述套圈扁丝结构的截面厚度P和高度Q比为1:3～1:2。
进一步，所述扁丝结构的截面为矩形或开口朝向套圈纵轴方向的扇环形。
当扁丝结构截面形状呈矩形时，套圈整体构成类似于工字钢结构，在垂直套圈平面方向上能够承受更大的力而不易变形，从而能够提供更大的压持力，以便更容易压住息肉组织，有效将组织完全套入套圈内。当扁丝结构截面形状呈开口朝向套圈纵轴方向的扇环形(类似为C形)时，朝向套圈内侧的弧形开口更容易扣紧抓住套圈内息肉组织，并且由于扁丝高度方向的上下两端呈弧形曲面，从而使得套圈与外管内壁的弧度相适应，当套圈在外管内往复滑动时，顺滑度大大提高。
进一步，所述套圈上设有刻度。所述固定部为设置在所述套圈与所述拉索固定连接端外部且位于所述外管内部的铆接管。所述套圈由医用不锈钢、镍钛合金和钴铬合金定型而成。
综上所述，由于采用了上述技术方案，本申请的有益效果是：
1)本申请通过优化套圈丝材结构，使得在临床中医生更容易通过此结构压住息肉，将息肉完全提拉起来，特别对于扁平的无蒂或亚蒂息肉，更容易将病灶完全且彻底地套在圈套器内，从而保证息肉切除的更彻底。
2)进一步，本申请提供的类似球拍型的组织切除的圈套器，通过套圈上设置强固弯折部结构，实现套圈直径档位可调的技术效果，在套取不同直径病灶组织时，套圈中强固弯折部的支撑作用更好、形变更为灵活。同时，由于强固弯折部的折弯特性，在套取组织过程中，套圈的形状基本不会因套圈直径变化而改变，套圈形状始终呈类似球拍形，因此在针对不同直径的病灶进行切除时，不必反复更换不同规格的圈套器，从而实现一个圈套器就可以切除不同直径病灶的目的。
3)此外，由于套圈两端拉入外管中时，套圈扁丝结构高度方向上的两端位置与在外管外的相对位置基本相同，套圈两侧边呈平行放置，套圈的两侧扁丝的厚度之和小于外管直径，当套圈收拢并拉入至外管中时，套圈在外管中滑动过程更为顺滑。
附图说明
图1示出了套圈不同档位下的结构示意图；
图2示出了套圈具有尾部银焊点和铆接管的圈套器远端示意图；
图3示出了套圈器中强固弯折部5的结构示意图；
图4示出了标注L1和L2位置的套圈示意图；
图5示出了截面呈矩形的扁丝结构立体示意图；
图6示出了截面呈矩形的扁丝结构中厚度和高度标注图；
图7示出了截面呈扇环形的扁丝结构立体示意图；
图8示出了截面呈弧形的扁丝结构中厚度和高度标注图；
图9示出了手柄最大行程示意图；
图10示出了圈套器套圈压力测试工装图；
图11示出了现有技术中3*3多股编织丝线截面图；
图12示出了现有技术中1*7多股编织丝线截面图。
附图标记：
1-套圈 2-尾部银焊点 3-铆接管 4-拉索 5-强固弯折部 6-外管 7-手柄 8-控制滑块
具体实施方式
下面结合附图，对本申请作详细的说明。
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
本申请中圈套器的工作过程：如图1、图2和图9所示，首先根据患者病灶部位选择合适长度外管的圈套器，然后将圈套器置入内窥镜工作通道并使得圈套器外管远端(远端是指与体外操作端相对的，位于人体内部的一端)放置到病灶部位，根据病灶部位的息肉直径，通过调整圈套器手柄7上的控制滑块8(图9所示)将圈套器的套圈1直径调整到略微大于息肉的直径，然后将圈套器的套圈1套在病灶的蒂部，并且保证套圈1横向平面与病灶的横向平面近似平行。套圈1放置完成后，通过滑动手柄7上的与拉索4固定连接的控制滑块8，将拉索4向近端拉动，拉索4带动套圈1收回到外管6内，此时套圈1直径变小，但套圈1的球拍形状基本保持不变。待套圈1部分收入到外管6中，将息肉收紧，息肉在套圈1上突出。此时开启联接圈套器的有源设备(图中未示)的高频电流，息肉在 高频电流的作用下被切割下来。如果患者需要继续切除其他直径的息肉或病灶，可以通过滑动手柄7上的滑块8来带动拉索进而更改圈套器的套圈直径，将套圈1放置于新的待切割病灶处，继续进行组织切割，而不必更换其他规格的新的圈套器。
本申请中圈套器的工作原理：如图1所示，套圈1在缓慢拉回并进入外管6中后，在抓握紧组织(有蒂息肉或无蒂息肉等)之前，球拍形套圈1两侧沿纵轴轴向对称的设置的可折弯强固弯折部5相互靠近，套圈1在长度方向和径向方向上同步变小，使得套圈1整体外形基本保持类似球拍形状，从而可以在不同套圈直径下轻松套取不同直径的息肉或病灶组织。其中，所述强固弯折部5由套圈1扁丝结构在同一平面内对向弯折一定角度后通过对折弯处进行增强处理后形成强度增强结构，所述强度增强结构为增强焊料和/或增强包覆层，所述套圈1轴向对称的两侧扁丝结构分别至少具有一弧形段扁丝结构和一直线段扁丝结构，所述强固弯折部5位于所述弧形段扁丝结构向直线段扁丝结构过渡位置。基于图1-4所示，本申请优选的结构是，位于套圈近端的直形段、位于套圈远端的弧形段、直形段的近端与弧形段的远端固定连接并形成可折弯的强固弯折部。
在临床中，医生在使用本申请中的圈套器时，更容易用扁丝形状的套圈压住息肉，将息肉完全提拉起来，特别对于扁平息肉，更容易将病灶完全彻底套在圈套器内，从而确保息肉被切除的更干净，防止息肉切除不彻底。套紧息肉后可以通电进行热切割，实现内镜下圈套器息肉热切除术。
实施例一
如图1-3所示，配置成组织切除的圈套器至少包括如下结构：具有近端和远端的中空外管6；位于所述外管6中，且可沿其纵轴方向往复移动的拉索4；设置于所述拉索4远端的套圈1，通过沿纵轴方向移动所述拉索4以将所述套圈1拉入或推出所述外管6，进而改变所述套圈1内部圈套面积，在拉索的远端设有配置成将所述套圈1近端与所述拉索4远端固定连接的固定部，该固定部优选为设置在所述套圈1与所述拉索4结合端外部且位于所述外管6内部的铆接管3，当然还可以采用焊接等其他现有常规的固定连接手段。此外，如图2所示，为了提高套圈整体构型的稳定性，更好地实现变径不变形的技术效果，在套圈1与拉索4形成的固定部的远端位置设置套圈的尾部银焊点2，配置成将套圈轴向对称两侧扁丝结构进行预先固定，固定方式除银焊接外，还可采用现有技术中其他常规的固定连接方式，通过将套圈1近端两侧扁丝进行预先固定，再使套圈1两侧扁丝整体与拉索4固定连接的方式，提高了套圈近端的抗形变能力，能够给套圈上强固弯折部折弯过程提供 足够的支撑力，进而更好地实现套圈的变径不变形的技术效果。
其中，所述套圈1为单股扁丝结构，所述扁丝结构的厚度P与高度Q比为1:1.5～1:4，所述套圈1沿纵轴方向轴向对称，且在所述套圈轴向对称的两侧分别设有强固弯折部。套圈1优选由不锈钢、镍钛合金或钴铬合金等一种或多种定型而成，当然可以采用现有技术中能够用于体内的其他材质。该实施例中，单股扁丝结构的套圈整体刚性远远大于传统多股圆丝构成的套圈结构，主要原因在于：传统套圈通常由多股圆丝编织而成，采用3*3(由三根分别由三根细丝编织而成的丝线编织而成，具体见图11)或1*7(由一根中心细丝和围绕于中心细丝的六根细丝编织而成的丝线，具体见图12)编织规格，总外径控制在0.4mm以内，例如1*7规格的多股套圈是由7根圆丝编织而成，而每根圆丝的直径约为0.16mm，圆丝直径较小，相应的抗形变能力较小；而本申请中单股扁丝套圈丝截面高度为0.18～0.48mm，扁丝截面的厚度约为0.12～0.2mm，其中，优选套圈丝截面高度约为0.4mm时厚度约为0.2mm,高度约为0.381mm时厚度约为0.127mm。相比于传统的多股圆丝结构，本申请中采用的单股扁丝结构具有更优的抗形变能力，对病灶组织能够提供更强的抓握力。
如图5和图6所示，所述扁丝结构截面可以为矩形，当扁丝结构截面形状呈矩形时，套圈整体构成类似于工字钢结构，在垂直套圈平面方向上能够承受更大的力而不易变形，从而能够提供更大的压持力，以便更容易压住息肉组织，有效将组织完全套入圈套内。如图7和图8所示，所述扁丝结构截面可以为开口朝向套圈纵轴方向的扇环形,当扁丝结构截面形状呈开口朝向套圈纵轴方向的扇环形时(类似为C形)，朝向套圈内侧的弧形开口更容易扣紧抓住套圈内息肉组织，并且由于扁丝高度方向的上下两端呈弧形曲面，从而使得套圈与外管内壁的弧度相适应，当套圈在外管内往复滑动时，顺滑度大大提高。
如图10所示，为圈套器套圈丝承受压力测试工装示意图，将待测套圈丝结构的一端固定于固定工装结构上，另外一自由端作为测试点，测试点至工装固定点间距离为20mm，向测试点施加压力后，记录套圈丝形变后的自由端到达一定受压距离，自由端所需施加的压力。相同受压距离，该压力值越大表明压持性能越好。表1为扁丝结构套圈与现有1*7规格套圈不同参数列表，以及不同规格套圈对应的强度百分比的参数对照表格。
表1
Figure PCTCN2020095273-appb-000001
Figure PCTCN2020095273-appb-000002
表1中前6行5列中横坐标数值代表扁丝截面的厚度P与高度Q的比值，分别为1:1.5、1:2、1:3和1:4(分别对应的具体尺寸举例为0.12mm/0.18mm、0.20mm/0.40mm、0.127mm/0.381mm和0.12mm/0.48mm)，纵坐标数值代表套圈测试压力时的自由端的受压距离(套圈垂直于厚度方向上受力后偏转距离)，横坐标与纵坐标之间的交叉区域二维值是指对应PQ值的套圈自由端偏离2mm、4mm……和10mm所需要施加的压力(单位是N)，相同受压距离，该压力值越大表明该尺寸套圈丝制作的圈套器压持性能越好。
表格中第6列是现有技术为采用7根圆丝编织而成1*7规格套圈(圈套器端部套住息肉的部分)成品，套圈丝线截面总外径约为0.4mm；第6列具体含义是对现有多股圆丝套圈进行压力测试时，当套圈丝线受压距离(垂直于长度方向偏转距离)分别为2mm、4mm、6mm、8mm和10mm时，自由端偏离2mm、4mm……和10mm所需要施加的压力分别对应为0.04N、0.07N、0.10N、0.12N和0.17N。当以现有技术1*7规格套圈丝自由端偏离10mm，所受压力0.17N作为基准受力值，设定其强度百分比为100％，反推得到同样自由端偏离10mm，不同PQ尺寸扁丝所需要施加的压力分别为0.15N、1.05N、0.30N和1.10N，相对于现有技术中采用1*7规格套圈的强度百分比，不同规格扁丝套圈的强度百分比分别为88％、618％、176％和647％。由此可以看出：
1)当扁丝截面P/Q值为1:1.5时，其中P小于0.1mm则套圈丝强度弱，以P*Q为0.12mm*0.18mm扁丝为例，与现有技术1*7套圈丝相比，强度百分比是0.15N/0.17N＝88％，接近100％，Q值越大，P/Q比值下降，强度百分比将提高。
2)当扁丝截面P/Q值为1:4时，扁丝的强度虽然足够大，但是扁丝高度过大(0.48mm)，大于现有技术中1*7规格套圈的编织圆丝总外径0.4mm，在临床手术中易造成切割创伤大，切割不锋利，故不适于临床使用。
故而本申请中扁丝截面P/Q值范围优选大于1:4且小于1:1.5，且P与Q应满足0.1mm<P<Q<0.48mm。
实施例二
如图3和图4所示，在实施例一的基础上，套圈结构中进一步包括设置在沿套圈纵轴轴向对称设置的强固弯折部5。如图4所示，套圈轴向对称的两侧最大间距定义为圈套器 的套圈直径L1，套圈最远端与外管最远端间距离定义为套圈沿纵轴方向伸出距离值L2，L1与L2的比值优选为1：1.5～1：4，表2和表3为本申请中L1和L2以及L1/L2不同参数对照表格。
表2
Figure PCTCN2020095273-appb-000003
表2中横坐标是L1与L2的比值，分别为1:1.5、1:2.34、1:3和1:4四个规格，纵坐标表示的是圈套器套圈直径L1数值；表格中交叉区域二维数据表示L2(单位是mm)的数值。
表3
Figure PCTCN2020095273-appb-000004
表3中，横坐标表示L1与L2的比值；纵坐标表示圈套器套圈直径L1数值；交叉二维值表示L3(单位是mm)，其中L3表示手柄7上控制滑块8可移动的最大行程(参见图9)，L3通常对应于人手指可控尺寸极限。
由表2和表3可以看出：
1)当套圈直径L1＝20时，L1/L2为1:1.5对应的L2过小，导致拉伸行程较小，可变行程过短，临床不适用，故L1/L2小于1:1.5的套圈不适用。
2)当套圈直径L1＝40时，滑块可移动的最大行程L3为240mm，行程较大(实际使用中一般最长不超过120mm)，不利于人手操作。
3)当套圈直径L1设定在20～40mm这一范围内时，根据表格中相应的参数可以看出L1/L2在1:1.5和1:4之间较为合适。
综上，根据以上表2和表3，临床中，圈套器套圈直径L1为30mm或40mm时，L1/L2优选1:1.5～1:2.34之间。圈套器套圈直径L1为20mm或30mm时，L1/L2选择1:2.34～1:4 之间；L1/L2大于1:4的圈套器在临床中不适用。
实施例一或实施例二中所述强固弯折部5具有增强的折弯结构，能够在套圈形变过程中基本维持折弯拐点，进而保证套圈在抓握组织过程中形态基本保持球拍形状不变，达到变径不变形的技术效果。所述强固弯折部5由套圈扁丝结构在同一平面内对向弯折一定角度后通过对折弯处进行增强处理后形成强度增强结构，其中，强度增强结构优选为增强焊料或者增强包覆层，所述焊料优选不易断裂且柔韧的金属材质，如银，以形成为银焊层，从而确保在形变过程中，强固弯折部5具有足够的折弯稳定性，不易断裂。
表4
Figure PCTCN2020095273-appb-000005
如表4所示，通过测试现有常规不具备强固弯折部的扁丝套圈产品、某对称设有具有扭转角的扁丝套圈产品以及本申请中具有强固弯折部的扁丝套圈在回缩过程中套圈直径变化值，进一步证明本申请中套圈基本实现变径不变形的有益效果。测试过程中，手柄上滑块向近端移动以使套圈回缩过程中，滑块移动不同距离时，分别测量三种产品中套圈直径，通过比较可以看出，本申请中套圈直径减小趋势相比于另外两个产品明显减缓，尤其在滑块移动5-20mm这一距离时尤为明显，而这一移动距离正是对应套圈抓取组织过程的重要节点，这一过程中套圈直径减小速度的降低，可以为套圈提供足够的时间和空间来充分调整并抓取息肉组织，大大提升套圈的抓握组织能力。
可见，相比于现有不具备强固弯折部的套圈结构，本申请中的套圈在回收过程中基于该强固弯折部的折弯特性，减缓套圈在回收过程中形态迅速向中心轴靠拢的趋势，从而基本实现了变径不变形的效果。相比于现有技术中不设置强固弯折部或者扁丝扭转弯折结构，本申请中将扁丝在同一平面内对向弯折获得的强固弯折结构最大限度的确保在回收套圈过程中折弯位置和形态相对稳定，套圈整体形态基本维持球拍形状，有效提升套圈的抓握组织能力。
实施例三
基于实施例一或实施例二，所述套圈轴向对称的两侧分别至少包括一弧形段扁丝结构和一直线段扁丝结构，强固弯折部5配置成将两段扁丝结构的端部固定连接并形成可折弯结构，其中所述两段扁丝结构中的任意一个为沿扁丝长度方向延伸的直线段或弧形段，本实施例优选强固弯折部5的位置即为直线段向弧形段过渡位置。只要能保持套圈在套取息肉等组织之前，通过强固弯折部可折弯特性，确保在套圈进入外管时，套圈轴向对称的两侧扁丝间距不迅速靠拢，套圈整体形态基本维持稳定即可。如图3和图4所示，本申请优选套圈中远端为直形段并且近端为弧形段，直形段的近端与弧形段的远端过渡区域即构成强固弯折部5，这样设计的优点在于套圈结构相对简单并且稳定可靠，且能够实现在抓握组织过程中套圈形态基本呈球拍形，达到抓握组织过程中变径不变形的技术效果。
本实施例中进一步，强固弯折部距远端轴向距离d1(如图4所示)与套圈沿纵轴方向伸出距离值L2的比值小于1/2，其中，强固弯折部距远端轴向距离d1为强固弯折部在套圈轴向投影位置与套圈最远端间的长度，套圈沿纵轴方向伸出距离值L2为套圈最远端与外管间距离。通过不断反复试验和优化，研发人员发现强固弯折部的设置位置影响变径不变形的效果，通过大量试验发现当强固弯折部距远端轴向距离d1与套圈沿纵轴方向伸出距离值L2的比值小于1/2，甚至更小值时变径不变形效果最佳，进而抓握息肉能力最强。本实施例中举例说明不同d1/L2时，套圈变径不变形效果的差异。
表5
Figure PCTCN2020095273-appb-000006
Figure PCTCN2020095273-appb-000007
如表5所示，通过测试d1/L2分别为1/2、1/4和1/6的扁丝套圈在回缩过程中套圈直径变化值，以对比本申请中套圈中强固弯折部在不同位置下实现变径不变形的有益效果差异。测试过程中，手柄上滑块向近端移动以使套圈回缩过程中，滑块移动不同距离时，分别测量三种强固弯折部不同位置下的套圈直径，通过比较可以看出，d1/L2为1/4时强固弯折部的减缓形变作用最强，强固弯折部越靠近套圈中部或越靠近套圈远端部，抗形变性能相应减弱，通过反复测试，当1/6<d1/L2<1/2时，强固弯折部的减缓套圈形变能力最强。
实施例四
在上述实施例的基础上，所述套圈上带刻度，用激光在扁丝侧面上打标记，作为测量刻度，方便医生在内窥镜下更好的比对息肉或病变大小，准确地估计病灶尺寸，用视频截图，将息肉大小准确的保存下来，为以后的精准治疗提供原始精确数据。在实施病灶切除时，圈套器上的刻度可以帮助医生估计出病灶的尺寸，使医生准确判断病灶体积，避免判断错误。
实施例五
套圈扁丝结构的高度为0.38mm，厚度为0.13mm时，套圈两侧扁丝左右并列设置在外管中时，扁丝厚度之和为0.26mm，拉索直径是0.8mm，外管内径是1.5mm，通过此参数可知，套圈收拢后很容易在外管中被拉动而进行往复运动。
可见，由于套圈两端拉入外管中时，套圈扁丝结构高度方向上的两端位置与在外管外的相对位置基本相同，套圈两侧边呈平行放置，套圈的两侧扁丝的厚度之和小于外管直径，当套圈收拢并拉入至外管中时，套圈在外管中滑动过程更为顺滑。
实施例六
在上述实施例基础上，本申请通过设置强固弯折部，实现了套圈直径L1由10mm到40mm不等规格的圈套器，每个规格的圈套器增减档位最小刻度为5mm或者10mm，完全能实现同一规格圈套器对不同直径的息肉进行切除的需求。其中套圈器的套圈直径L1是指套圈轴向对称的两侧最大间距。
例如：手术时，提供的圈套器规格是40mm，进入到操作部位附近时，发现息肉直径与预想尺寸差异较大，直径仅为22mm左右，则此时可在套住息肉前，先对圈套器进行预操作，将其套圈直径L1先变化为30mm，此时圈套器还是保持原有的球拍型。然后在将此时状态的圈套器套圈套住息肉，再缩小此时套圈直径，完成抓握息肉组织的过程。
最后应说明的是：以上各实施例仅用以说明本申请的技术方案，而非对其限制；尽管参照前述各实施例对本申请进行了详细的说明，但本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的范围。

Claims (10)

  1. 一种用于组织切除的圈套器，至少包括如下结构：
    具有近端和远端的中空外管；
    位于所述外管中，且可沿其纵轴方向往复移动的拉索；
    设置于所述拉索远端的套圈，通过沿纵轴方向移动所述拉索以将所述套圈拉入或推出所述外管，进而改变所述套圈内部圈套面积；
    配置成将所述套圈近端与所述拉索远端固定连接的固定部；
    其特征在于：所述套圈为单股扁丝结构，所述扁丝结构的截面厚度P与高度Q比为1:4～1:1.5，其中，所述套圈沿纵轴方向轴向对称，且在所述套圈轴向两侧轴向相对设有强固弯折部。
  2. 根据权利要求1所述的圈套器，其特征在于：
    所述强固弯折部由套圈扁丝结构预弯形成且在所述强固弯折部处的扁丝结构具有强度增强结构。
  3. 根据权利要求2所述的圈套器，其特征在于：
    所述强固弯折部由套圈扁丝结构在同一平面内对向弯折一定角度后通过对折弯处进行增强处理后形成强度增强结构，所述强度增强结构包括增强覆料。
  4. 根据权利要求1所述的圈套器，其特征在于：
    强固弯折部距远端轴向距离d1与套圈沿纵轴方向伸出距离值L2的比值小于1/2，其中，强固弯折部距远端轴向距离d1为强固弯折部在套圈轴向投影位置与套圈最远端间的长度，套圈沿纵轴方向伸出距离值L2为套圈最远端与外管最远端间距离。
  5. 根据权利要求4所述的圈套器，其特征在于：
    所述圈套器的套圈直径L1与套圈沿纵轴方向伸出距离值L2的比值为1:4～1:1.5，其中，所述套圈器的套圈直径L1为所述套圈轴向对称的两侧最大间距，套圈沿纵轴方向伸出距离值L2为套圈最远端与外管最远端间距离。
  6. 根据权利要求5所述的圈套器，其特征在于：L1与L2的比值为1:3～1:2.34，L1的数值范围为10mm～40mm。
  7. 根据权利要求1所述的圈套器，其特征在于：
    所述套圈轴向对称的两侧扁丝结构分别至少具有一弧形段扁丝结构和一直线段扁丝结构，所述强固弯折部位于所述弧形段扁丝结构向直线段扁丝结构过渡位置。
  8. 根据权利要求1至7所述的圈套器，其特征在于：
    所述套圈扁丝结构的截面厚度P和高度Q比为1:3～1:2。
  9. 根据权利要求1至7所述的圈套器，其特征在于：所述扁丝结构的截面为矩形或开口朝向套圈纵轴方向的扇环形。
  10. 根据权利要求1至7任一项所述的圈套器，其特征在于：所述套圈上设有刻度。
PCT/CN2020/095273 2019-09-30 2020-06-10 一种用于组织切除的圈套器 Ceased WO2021063024A1 (zh)

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