Endoscope auxiliary device for gastrointestinal polyp measurement

Abstract

An endoscope auxiliary device for measuring gastrointestinal polyps mainly comprises a polyp measuring scale, a pushing tube and an operating handle, overcomes estimation errors caused by distortion and zooming of a fisheye lens of an endoscope in the prior art, and fills the technical blank of accurate physical measurement of polyp forms. Meanwhile, the device can be used for physically measuring the size of the polyp in the digestive tract under the endoscope, and can also be combined with an endoscope administration tube to realize clinical functions of polyp measurement, lavage, liquid medicine spraying and radiography.

Description

Technical Field

[0001] The present application relates to an endoscopic auxiliary device for measuring gastrointestinal polyps, which is a medical device used in conjunction with endoscopic diagnosis and treatment. Background Art

[0002] Gastroscopy and colonoscopy are used for early detection of digestive tract tumors and minimally invasive procedures such as polypectomy. These techniques offer advantages such as simplicity, efficiency, minimal damage, and a quick recovery period. Polyps in the digestive tract are important markers of early tumor development. Medical research has confirmed that early detection of digestive tract polyps through endoscopic examinations and prompt endoscopic resection are effective means of preventing the development and progression of digestive tract cancers, reducing their morbidity and mortality.

[0003] The European Society of Gastrointestinal Endoscopy (ESGE) Guidelines for Colorectal Polypectomy (2017 Edition) state in the "Definition and Classification of Polyps" that polyps should be described and reported according to their location, size (in mm), and morphology during endoscopic examination. Furthermore, in the "Definition of Polypectomy and Mucosal Resection," the guidelines further clarify that different surgical procedures should be selected based on polyp size. For example, cold snare polypectomy is recommended for the removal of microscopic polyps (≤5 mm) or small polyps (6-9 mm), hot snare polypectomy (HSP) is recommended for the removal of flat and sessile polyps (10-19 mm), and conventional (diathermy-based) endoscopic mucosal resection (EMR) is recommended for the removal of large (≥20 mm) sessile adenomatous polyps. Therefore, polyp size is a key clinical indicator during endoscopic examination or polypectomy. However, due to limitations in endoscopic technology (such as fisheye lens distortion and polyp size changes caused by zoom), endoscopes cannot measure polyp size. Polyp size measurement is highly dependent on the endoscopist's estimation, which is subject to considerable subjectivity. A study conducted by the Department of Gastroenterology at Centro Hospitalar de Leilia in Portugal, which included 573 polyps, examined the discrepancies between polyp size reported by endoscopists and pathological measurements. The results showed that the error rate in polyp estimation was as high as 62.1%, and that polyp size tended to be significantly overestimated by endoscopists.

[0004] Accurately measuring polyp size is crucial for assessing gastrointestinal cancer risk and selecting surgical options. Inaccurate size estimation can lead to misdiagnosis, unnecessary medical procedures, or the selection of the wrong surgical approach. To address the shortcomings of existing technologies, this application proposes a technical solution that can accurately calculate polyp size during endoscopic diagnosis or surgery, meeting an urgent clinical need. Summary of the Invention

[0005] An endoscope-assisted device for measuring gastrointestinal polyps mainly comprises a polyp measuring ruler, a pushing tube and an operating handle.

[0006] The polyp ruler is a micro-scale ruler made of shape memory material. The polyp ruler can be folded or contracted in the endoscope instrument channel or the sheath cavity, and can quickly return to its original shape after being released.

[0007] The shape memory materials used in the preparation of polyp measuring tape include, but are not limited to, shape memory alloys (SMA) or shape memory polymers (SMP). For example, nickel-titanium-based shape memory alloys, copper-based shape memory alloys, iron-based shape memory alloys, and other shape memory alloys from the shape memory alloy family; or silicone rubber, thermoplastic polyester elastomers, thermoplastic polystyrene-butadiene elastomers, thermoplastic polyurethane elastomers, and thermoplastic plastics with cross-linked structures from the shape memory polymer family.

[0008] The external structure of the polyp ruler adopts the regular structural shape of a universal measuring tool, including a circular, elliptical, semicircular, triangular, square or ruler structure.

[0009] The surface of the polyp ruler is provided with scale indications, and the interior of the polyp ruler is transparent or hollow.

[0010] The minimum reading on the polyp scale is 1mm, and the measuring range is between 5mm and 20mm. For example, polyp scales are available in four sizes: 5mm, 10mm, 15mm, and 20mm, with a minimum reading of 1mm. In clinical practice, doctors can select an appropriate polyp scale size based on the size of the polyp visually assessed under endoscopy.

[0011] Preferably, the polyp measuring ruler is made of a wire-shaped shape memory alloy material with an outer diameter of 0.1 mm to 0.3 mm, and is prepared as a circular coil structure. The model specifications are divided into four measuring ranges of 5 mm, 10 mm, 15 mm, and 20 mm, and the minimum indication of the measuring scale is 1 mm.

[0012] In one embodiment, the polyp scale is further provided with a height scale, which intersects the polyp scale perpendicularly and has a minimum graduation of 1 mm. For example, the height scale is positioned on the periphery of the polyp scale, intersecting perpendicularly therewith. The height scale can be integrally formed with the polyp scale or fabricated by welding.

[0013] In actual production, to prevent the scales of polyp gauges or height gauges from becoming inaccurate due to pressure deformation during storage and transportation, protective caps are installed around the polyp gauge and height indicator. The outer shape of the cap is not limited, and the internal protective cavity matches the size and shape of the polyp gauge and height gauge. The cap is made of medical polymer materials or metal materials, such as medical polyvinyl chloride or polypropylene plastics, or aluminum alloy.

[0014] The push tube is a slender tube that folds or compresses the polyp ruler and sends it into the endoscope instrument channel, and controls the polyp ruler to measure the surface of the polyp. The polyp ruler is firmly assembled on the head of the push tube.

[0015] Depending on the intended patient (e.g., children vs. adults) and the endoscopic diagnostic and treatment site (e.g., gastroscopy or colonoscopy), push tube lengths range from 900mm to 2500mm in various models. Depending on the inner diameter of the endoscopic instrument channel, the push tube outer diameter ranges from 1mm to 3.6mm in various specifications. The push tube can be made of any material, including metal guidewires and nylon tubing. To enhance its ability to pass through the endoscopic instrument channel, the push tube is required to have a smooth, elastic, and rigid surface.

[0016] In one embodiment, the combined portion of the polyp scale and the push tube is used as a height scale. Specifically, a measuring scale is provided on the head of the push tube, and the head of the push tube and the outer periphery of the polyp scale are vertically intersected and combined. The intersection point of the intersection is marked as the height value of 0mm. From the value of 0mm upward, height indications of 1mm to 20mm are marked on the head of the push tube, forming a height scale for measuring polyp height.

[0017] In another embodiment, the polyp measuring ruler and the push tube are integrally formed. For example, a shape memory alloy is used to form a guide wire, the head of the guide wire is processed into a polyp measuring ruler and can meet the technical requirements of folding or compressing, and the rear end of the guide wire can meet the requirements of the push tube.

[0018] The operating handle is a control device for advancing or withdrawing the polyp measuring tape and the push tube within the endoscope instrument channel. The operating handle is located at the end of the push tube. The structure and shape of the operating handle are not limited, and the structure and size that meet ergonomic requirements and can be easily grasped and operated are preferably selected.

[0019] Furthermore, in order to prevent the polyp scale from being affected by wear or deformation caused by friction during its movement in the endoscope instrument channel, which would affect the accuracy of the polyp scale, a sheath is provided on the outer periphery of the push tube. The sheath is a flexible tube made of extruded medical polymer material and has an inlet and outlet channel for the push tube and the polyp scale inside. After the polyp scale is folded or compressed, it is pushed into the cavity of the sheath head for temporary storage. After the sheath reaches the polyp site through the auxiliary channel of the endoscope, the operating handle controls the push tube and the polyp scale to move forward toward the end of the endoscope head, releasing the polyp scale from the sheath head.

[0020] The length and inner diameter of the sheath should correspond to and be adapted to the sizes of the corresponding push tube and polyp scale, so that the polyp scale and push tube can move in and out of the sheath freely.

[0021] To improve the combination capabilities of endoscopic instruments and facilitate medical personnel to conveniently perform various clinical operations such as polyp measurement, coloring, or medication application, in another embodiment, a push tube, a polyp scale, and an endoscopic drug delivery tube are combined. The polyp scale is folded or compressed and pushed into the lumen of the endoscopic drug delivery tube. The polyp scale is temporarily stored in the lumen of the endoscope drug delivery tube head, forming an endoscopic instrument with multiple functions including polyp measurement and irrigation, drug spraying, and angiography.

[0022] Preferably, the endoscopic drug delivery tube is prepared as a double-lumen catheter, one lumen is used for endoscopic drug delivery, and the other lumen is used to place a polyp ruler and a push tube. The polyp ruler is temporarily stored in the lumen at the head of the endoscopic drug delivery tube, and the operating handle of the push tube is exposed 5mm to 20mm from the tail end of the endoscopic drug delivery tube.

[0023] After the endoscope drug delivery tube is delivered to the polyp site through the endoscope auxiliary channel, the polyp scale is released from the endoscope drug delivery tube head by controlling the push tube and the polyp scale to move forward to the endoscope head end.

[0024] The clinical use of this application is to be used for the physical measurement of the size of polyps in the digestive tract under endoscopy. It can also be combined with an endoscopic drug delivery tube to achieve clinical functions including polyp measurement, irrigation, spraying of drug solution and angiography.

[0025] The present application provides the beneficial effect of utilizing a shape-memory material to create a foldable or compressible polyp ruler. Once pushed to the periphery of a polyp, the ruler is released and stretches or returns to its original, fixed shape. The ruler can be placed around the periphery of a polyp or horizontally above it to physically measure its size. Furthermore, a height gauge is also provided on the periphery of the polyp ruler, enabling simultaneous physical measurement of polyp height, providing richer polyp size data. This overcomes the estimation errors caused by the distortion and zoom of the fisheye lens in existing endoscopic techniques, thus filling a technological gap in the precise physical measurement of polyp morphology.

[0026] Furthermore, with the increasing popularity of the development and application of medical decision-making support software or mathematical calculation applets, for example, the image information of the polyp ruler and the polyp formed on the same surface during measurement is used, virtual auxiliary lines are added to the polyp image, and the scale of the polyp ruler is used as a reference to overcome the distortion caused by the fisheye lens or zoom. The general mathematical or geometric calculation formulas are used to calculate richer polyp morphological information, including the maximum length, minimum length, circumference length and surface area of ​​the polyp.

[0027] The present invention has low preparation cost, simple operation, safety and reliability, and is worthy of clinical promotion and use. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present application

[0029] Figure 2 This is an enlarged close-up view of a circular polyp measuring ruler with a height gauge according to an embodiment of the present invention.

[0030] Figure 3 This is a schematic diagram of an embodiment of the polyp measuring ruler, push tube and sheath combination of the present application

[0031] Figure 4 This is a schematic diagram of the polyp scale in this application after it is released from the front end of the sheath.

[0032] Figure 5 This is a schematic diagram of an embodiment of the combination of the push tube, polyp measuring ruler and endoscope drug delivery tube of the present application.

[0033] Figure 6 This is an example of a method for measuring polyp size in clinical practice.

[0034] Figure 7 Schematic diagram of the combination of the push tube, polyp measuring ruler and double-lumen endoscope drug delivery tube of this application

[0035] In the figure: polyp scale 10, scale indication 101, height gauge 103, push tube 20, operating handle 30, sheath 40, endoscope drug delivery tube 50, drug delivery port sealing joint 501, drug delivery cavity 502, polyp 60 DETAILED DESCRIPTION

[0036] The present application is described in detail below with reference to the accompanying drawings and embodiments.

[0037] 1. Example 1: Preparation of a 20 mm round polyp measuring ruler 10

[0038] 1.1 Technical requirements for the circular polyp ruler 10: circumference 62.8mm (calculated based on the inner circumference of the circle), diameter 20mm, and the minimum scale indication 101 is 1mm.

[0039] 1.2 Material: The guide wire is made of nickel-titanium alloy (Ni-Ti) with shape memory properties. The outer diameter of the guide wire is 0.1 mm, and the cross section of the nickel-titanium alloy guide wire is circular.

[0040] 1.3 Design of the Wire Winding Mold: Design and prepare the wire winding mold for the polyp gauge 10. The mold is required to be a standard cylinder with an outer circumference of 62.8 mm and a diameter of 20 mm. A 0.13 mm wide and 20 mm long wire groove (i.e., the diameter line of the cylinder cross section) is located in the center of the cylinder.

[0041] 1.4 Molding of Polyp Gauge 10: Insert the nickel-titanium alloy guide wire into the diameter groove, with the tip of the nickel-titanium alloy guide wire flush with the outer circumference of the cylinder. Wind the nickel-titanium alloy guide wire around the outer circumference of the cylinder in a clockwise direction, and apply pre-tightening tension. Then send it into a tubular low-temperature heating furnace for heat treatment. The temperature of the low-temperature heating furnace is set between 350℃ and 450℃, and the holding time is 3 minutes. Annealing, immerse in cold water for rapid cooling and shaping. The round polyp gauge 10 after shaping should meet Figure 2 requirements.

[0042] 1.5 Use precision screen printing equipment to print scale on the outer periphery and diameter line of the polyp scale. The scale reading is 101 for 1mm and must be clearly discernible with the naked eye or after 1-2 times magnification.

[0043] 1.6 After preparation, use a precision vernier caliper to measure the measurement accuracy of the circular polyp ruler 10. The outer circumference, diameter and scale indication 101 should meet the design requirements.

[0044] It should be noted that other circular polyp rulers 10 with different measuring ranges (5mm, 10mm, 15mm) can be implemented with reference to the above technical solution; the processes of square or triangular polyp rulers 10 only differ in the shape of the winding molding mold in item 1.3, and the technical solutions are the same, which will not be described in detail.

[0045] 2. Example 2: Preparation of an Endoscopic Drug Delivery Tube with Gastrointestinal Polyp Measurement Function

[0046] 2.1 Mould design and manufacturing

[0047] 2.1.1 As Figure 5 The structure shown is designed and manufactured respectively for the extrusion molds of the push tube 20 and the drug delivery tube, and the injection molds of the operating handle 30, the protective cap and the drug delivery port closing joint 501.

[0048] 2.1.2 The extrusion die of the push tube 20 is suitable for extrusion molding of nylon tubes with an outer diameter of 1.5 mm.

[0049] 2.1.3 The extrusion die for the drug delivery tube is suitable for the extrusion molding of soft polyvinyl chloride tubes. The extruded drug delivery tube has an outer diameter of 2.6 mm and an inner diameter of 1.8 mm.

[0050] 2.1.4 The injection mold for the operating handle is suitable for injection molding of polyvinyl chloride materials. The operating handle 30 is a cylindrical handle with a length of 100 mm and an outer diameter of 30 mm. A mounting hole with an inner diameter of 1.6 mm and a depth of 8 mm is located in the center of the head of the operating handle 30. The outer periphery of the operating handle 30 is provided with an irregular concave and convex anti-slip structure.

[0051] 2.1.5 The injection mold of the protective cap is suitable for injection molding of medical polypropylene material, and is required to be able to completely enclose the polyp ruler 10 and the head of the push tube 20 inside, and to prevent the polyp ruler 10 and the head of the push tube 20 from being impacted by external pressure.

[0052] 2.1.6 The injection mold of the drug delivery port closed joint 501 is suitable for injection molding of polyvinyl chloride materials. The inner diameter of the head end of the drug delivery port closed joint 501 is 2.7 mm, and a matching sealing plug is provided at the tail end.

[0053] 2.2 Material production

[0054] 2.2.1 Use nylon 1010 material and extrusion equipment to extrude the push tube 20, and cut it into sections of 1500mm each.

[0055] 2.2.2 Use medical soft polyvinyl chloride particles, extrude them into drug delivery tubes using extrusion equipment, and cut them into sections of 1300mm each.

[0056] 2.2.3 Use medical polyvinyl chloride particles and injection molding equipment to prepare an operating handle 30.

[0057] 2.2.4 Use medical polypropylene material particles and injection molding equipment to prepare protective caps.

[0058] 2.2.5 Use medical polyvinyl chloride particles and injection molding equipment to prepare a drug delivery port closure connector 501.

[0059] 2.3 Assembling pre-packaging

[0060] 2.3.1 Use medical glue to glue the tail of the cut push tube 20 into the mounting hole of the head of the operating handle 30. The tensile strength is required to be no less than 10N.

[0061] 2.3.2 Using high frequency welding equipment, weld the circular polyp ruler 10 prepared in Example 1 to the head end of the push tube 20. The push tube 20 and the circular polyp ruler 10 should be arranged at a 90-degree angle. Figure 2 .

[0062] 2.4 Take the intersection of the push tube and the circular polyp scale as the height value of 0mm, use precision screen printing equipment to print and mark the height indication of 0mm to 20mm on the head of the push tube to form a height scale for polyp height measurement.

[0063] 2.5 After assembling the protective caps on the outer periphery of the head of the circular polyp ruler 10 and the push tube 20, put them together with the endoscope drug delivery tube 50 into a medical outer packaging bag, seal the bag, sterilize it, and after passing the inspection, set it aside.

[0064] Since the double-lumen drug delivery tube belongs to the conventional technology of multi-lumen catheter preparation, please refer to Figure 7 The structure is produced by conventional extrusion process and will not be described in detail in this description.

[0065] 3. Example 3: Clinical application of this application in the measurement of colorectal polyps 60

[0066] 3.1 After the endoscope enters the colorectum and detects the target polyp 60, the medical staff will first estimate the size of the polyp 60 and select the appropriate polyp ruler 10. For example, if the polyp 60 is visually estimated to be approximately 6-8 mm, a 10 mm polyp ruler 10 may be selected; if the polyp 60 is visually estimated to be larger than 10 mm, a 15 mm or 20 mm polyp ruler 10 may be selected.

[0067] 3.2 Open the 10mm product prepared in Example 2 and remove the protective cap. Figure 5 As shown, the polyp measuring ruler 10 is retracted or folded into the inner cavity of the head of the endoscope drug delivery tube 50 until the front end of the polyp measuring ruler 10 is flush with the head of the endoscope drug delivery tube 50.

[0068] 3.3 Insert the endoscope drug delivery tube 50 into the endoscope instrument channel, push the push tube 20 forward by operating the handle 30, release the polyp ruler 10 and height ruler 103 from the head of the endoscope drug delivery tube 50, and the polyp ruler 10 returns to a perfect circular shape, so that the plane size and height of the polyp 60 can be measured. Figure 4 shown.

[0069] Specific measurement methods include, for example, Figure 6 As shown, after the inner wall of the intersection of the polyp ruler 10 and the height ruler 103 is placed close to point A on the periphery of the polyp 60, the polyp ruler 10 is encircled around the periphery of the target polyp 60. Even through visual inspection, medical staff can accurately determine the surgical method to be used for the target polyp 60 in accordance with the ESGE colorectal polyp resection guidelines. The judgment basis is that the diameter of the polyp ruler 10 is 10 mm. Figure 6The target polyp 60 is completely covered by the inner circumference of the polyp scale 10. The maximum length of the polyp 60 (from point A to point C) is visually about 8 mm, which is a small polyp 60 (6-9 mm) as defined in the guidelines. Cold snare polypectomy is recommended for removal.

[0070] Then, the target polyp 60 captured by the polyp ruler 10 is photographed through the endoscope and imported into a computer. Using medical decision-making support software or image processing software, the scale of the polyp ruler 10 is used as a reference to accurately calculate the length of the polyp 60 from point A to point C and the width of the polyp 60 from point B to point D, with an accuracy error of no more than 1 mm. Furthermore, computer software's auxiliary line tools (such as length and width auxiliary lines and height auxiliary lines) can be used, using conventional mathematical formulas or artificial intelligence algorithms, to accurately calculate more comprehensive morphological information about the polyp 60, such as its height, circumference, and area, eliminating diagnostic errors caused by estimation.

[0071] During this process, if it is necessary to spray drugs or dyes onto the target polyp 60 through the endoscopic drug delivery tube 50, the push tube 20 can be easily pulled outward to retract the polyp measuring ruler 10 and then removed. Furthermore, if a dual-lumen endoscopic drug delivery tube 50 is used, drug delivery can be performed simultaneously through the other lumen of the drug delivery tube.

[0072] The above drawings and embodiments are intended only to illustrate the technical solutions of this application and are not intended to limit them. Although this application has been described in detail with reference to preferred embodiments, those skilled in the art should understand that the technical solutions of this application may be modified or replaced with equivalents without departing from the spirit and scope of the technical solutions of this application, and all such modifications should be encompassed by the claims of this application. They do not constitute any limitation on the scope of protection of this application.

Claims

1. An endoscopic auxiliary device for measuring gastrointestinal polyps, mainly comprising a polyp measuring ruler (10), a push tube (20) and an operating handle (30); characterized in that: The polyp ruler (10) is a micro-scale ruler made of shape memory material. The push tube (20) is a slender tube that folds or compresses the polyp ruler (10) and sends it into the endoscope instrument channel, and controls the polyp ruler (10) to measure the surface of the polyp (60). The polyp ruler (10) is firmly combined with the head of the push tube (20); the operating handle (30) is an operating control device for the polyp ruler (10) and the push tube (20) to advance or retreat in the endoscope instrument channel. The operating handle (30) is set at the end of the push tube (20); the surface of the polyp ruler (10) is provided with a scale indication (101), and the interior of the polyp ruler (10) is transparent or hollow.

2. The endoscopic auxiliary device for measuring gastrointestinal polyps according to claim 1, characterized in that: The external structure of the polyp ruler (10) adopts the regular structural shape of a universal measuring tool, including a circular, elliptical, semicircular, triangular, square or ruler structure.

3. The endoscopic auxiliary device for measuring gastrointestinal polyps according to claim 1, characterized in that: The minimum indication value of the polyp scale (10) is 1 mm, and the measuring range is between 5 mm and 20 mm.

4. The endoscopic auxiliary device for measuring gastrointestinal polyps according to claim 1, characterized in that: The polyp measuring ruler (10) is further provided with a height ruler (103), which intersects the polyp measuring ruler (10) vertically, and the minimum scale of the height ruler (103) is 1 mm.

5. The endoscopic auxiliary device for measuring gastrointestinal polyps according to claim 1, characterized in that: The head of the push tube (20) is provided with a measuring scale. The head of the push tube (20) and the outer periphery of the polyp scale (10) intersect vertically, and the intersection point of the intersection combination is marked as the 0mm value of the height value. From the 0mm value upward, the height indication values ​​of 1mm to 20mm are marked in sequence on the head of the push tube (20), forming a height scale (103) for measuring the height of the polyp (60).

6. The endoscopic auxiliary device for measuring gastrointestinal polyps according to claim 1, characterized in that: A sheath tube (40) is further provided on the outer periphery of the pushing tube (20). After the polyp measuring ruler (10) is folded or compressed, it is pushed into the cavity of the head of the sheath tube (40) for temporary storage.

7. The endoscopic auxiliary device for gastrointestinal polyp measurement according to claim 1, characterized in that: The push tube (20), the polyp measuring ruler (10) and the endoscope drug delivery tube (50) are combined to form an endoscope instrument with multiple functions including polyp (60) measurement and irrigation, spraying of liquid medicine and imaging.

8. The endoscopic auxiliary device for measuring gastrointestinal polyps according to claim 1, characterized in that: The endoscopic drug delivery tube (50) is prepared as a double-lumen catheter, wherein one lumen is used for endoscopic drug delivery, and the other lumen is used to place a polyp ruler (10) and a push tube (20). The polyp ruler (10) is temporarily stored in the lumen at the head of the endoscopic drug delivery tube (50), and the operating handle (30) of the push tube (20) is exposed 5 mm to 20 mm from the tail end of the endoscopic drug delivery tube (50).

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