Novel endoscope gastrointestinal injection needle

Abstract

The invention discloses a novel endoscope gastrointestinal injection needle, and relates to the technology of medical instruments, in particular to the novel endoscope gastrointestinal injection needle which comprises an injection port and a handle which are both made of ABS materials, the total length is 150.2 mm and the width is 29.79 mm after the injection port and the handle are assembled, the lower end of the handle is connected with an outer tube, the inner end of the outer tube is coaxially provided with an inner tube, and the inner tube is connected with the handle. The lower end of the inner tube is connected with a 304 stainless steel needle tube, and the lower end of the needle tube is provided with a double-needle-head structure, namely a first needle head and a second needle head. Through precise structural design, high-performance material selection and strict performance testing, unification of operation convenience, puncture stability and sterile safety is achieved, and the device is suitable for precise medicine injection under the gastrointestinal endoscope.

Description

Technical Field

[0001] This invention relates to medical device technology, specifically a novel endoscopic gastrointestinal injection needle. Background Technology

[0002] In the endoscopic diagnosis and treatment of gastrointestinal diseases, the gastrointestinal injection needle is an important auxiliary device, and its performance directly affects the safety, effectiveness and patient comfort of the operation.

[0003] However, existing patents have the following drawbacks:

[0004] (1) In terms of puncture operation, the single needle design has relatively limited functionality. For scenarios that require simultaneous drug injection and the establishment of a more stable channel or special tissue treatment, its adaptability and precise control capabilities are insufficient.

[0005] (2) In terms of user experience, there is still room for improvement in the ergonomic design of the handle and the flexibility of the inner tube (such as stability and smoothness after bending). In terms of structural reliability, the connection strength and sealing between the syringe and the inner tube, and between the inner tube and the handle are the key to ensuring safe operation and accurate drug delivery. Existing products cannot always fully meet the stringent requirements of complex clinical operations in terms of durability and stability of these connection parts.

[0006] (3) With the increasing awareness of medical aseptics and the improvement of infection control standards, as disposable medical devices, the entire process from packaging to sterilization must meet extremely high levels of aseptic assurance, which also puts forward comprehensive and detailed requirements for product design, production process and quality management. Summary of the Invention

[0007] The purpose of this invention is to provide a novel endoscopic gastrointestinal injection needle, which solves the problems of material properties, structural design, ease of operation, safety and hygiene standards mentioned in the background art by setting up a handle, inner tube, needle one and needle two.

[0008] To achieve the above objectives, the present invention is implemented through the following technical solution: a novel endoscopic gastrointestinal injection needle, comprising an injection port made of ABS material, a handle made of ABS material at the lower end of the injection port, and the injection port and handle having a length of 150.2 mm and a width of 29.79 mm after assembly.

[0009] Furthermore, the lower end of the handle is provided with an outer tube made of PTFE material. The outer tube has an outer diameter of 16.5 mm, an inner diameter of 2.45 mm, and a length of 2230 mm. The outer diameter and inner diameter errors of the outer tube are within ±0.10%, and the length error is within ±0.30%. The inner end of the outer tube is provided with an inner tube made of PEEK material. The inner tube has an outer diameter of 1.45 mm, an inner diameter of 0.95 mm, and a length of 2210 mm. The outer diameter and inner diameter errors of the inner tube are within ±0.10%, and the length error is within ±0.20%.

[0010] Furthermore, the lower end of the inner tube is provided with a needle tube, which is made of 304 stainless steel. The lower end of the needle tube is provided with a first needle and a second needle. The first needle has a diameter of 0.50-0.53 mm and a length of 13 mm, with a length error of ±1.0%. The second needle has a diameter of 0.60-0.63 mm and a length of 13 mm, with a length error of ±1.0%.

[0011] Furthermore, the first and second needles are driven by air pressure; the cutting edge of the first needle has three sharp surfaces, and the cutting edge of the second needle has four sharp surfaces. The length of the first and second needles protruding from the endoscope tip does not exceed 4mm. When performing needle insertion in the gastrointestinal tract, the first and second needles will not retract, thus facilitating the puncture operation and reducing patient pain and bleeding.

[0012] Furthermore, fix any point A on the needle tube, apply weight to point B to bend the inner tube to 12° and hold for 1 minute. After removing the weight, the inner tube should completely return to its original shape. The needle tube's pull-out resistance is satisfied. When a load of 22N is applied in the direction from which the needle tube is pulled out of the needle device, there is no loosening or pull-out phenomenon at the connection between the needle tube and the outer tube. Fix one end of the inner tube to the handle, apply a pulling force of not less than 3N in the opposite direction and hold for 15 seconds, and there is no breakage or separation at the connection.

[0013] Furthermore, the packaging quality of the injection needle meets the following requirements: the heat-sealed surface is flat and undamaged, the packaging is tightly sealed and leak-free; the packaging surface is free of foreign matter, stains or defects; the label is firmly attached and does not fall off, and the markings on the label, such as product name, specifications, sterilization mark, etc., are clear, complete and consistent with the actual product; the device is a disposable sterile product.

[0014] Furthermore, the end face of the handle is provided with a hook body, the surface roughness of the hook body Ra≤1.6μm, to avoid hand slippage during operation, and the inner end of the injection port is provided with a guide groove along the axial direction for uniform distribution of the drug solution during injection.

[0015] Furthermore, the inner wall of the outer tube is provided with a spiral liquid guiding groove to reduce the frictional resistance when the inner tube expands and contracts. The radial gap between the outer surface of the inner tube and the inner surface of the outer tube is 0.10-0.15mm to ensure the sliding flexibility of the inner tube within the outer tube.

[0016] Furthermore, the connecting end of the needle tube and the inner tube is provided with an annular boss, which is interference-fitted with the inner wall of the inner tube to achieve a sealed connection between the needle tube and the inner tube. The tips of the first needle and the second needle are rounded to reduce tissue damage during puncture.

[0017] Furthermore, the sterilization process of the injection needle adopts ethylene oxide sterilization, and the sterilization conditions include: a pre-conditioning stage temperature of 10-45℃ and a time of ≥120 minutes, and an air removal stage target pressure of -0.85 kgf / cm². 2 The humidity during the steam injection stage is 50±25% RH, and the target pressure during the EO gas injection stage is 0.70-0.05 kgf / cm³. 2 The concentration is 700-800 mg / L; the exposure stage temperature is 40±5℃, the humidity is 50±25%, and the exposure time is 240 minutes; the air replacement stage involves ≥2 flushing cycles and a pressure of -0.85 kgf / cm². 2 The air exposure stage temperature is 10-40℃ and the time is ≥48 hours, and the sterilization process must meet the requirements of ISO 11135 standard to ensure that the product reaches the sterility assurance level.

[0018] This invention provides a novel endoscopic gastrointestinal injection needle, which has the following beneficial effects:

[0019] 1. By selecting a variety of high-performance engineering materials such as ABS, PTFE, PEEK and 304 stainless steel and implementing precise tolerance control, combined with innovative precision structural design (such as a three- or four-sharp-faced needle system driven by air pressure, precisely controlled inner and outer tube gap and radial sliding degree of freedom, inner tube with excellent elastic recovery ability, hook-shaped anti-slip handle, internal flow guide system and spiral liquid guide groove structure).

[0020] 2. It achieves excellent assembly compatibility, operational stability, and precise and controllable puncture (such as a protrusion length of no more than 4mm and zero backlash), significantly reduces tissue damage and bleeding, optimizes the doctor's operating experience and drug delivery efficiency. Furthermore, with its strong mechanical connection strength (such as 22N pull-out force and 3N tensile force) and ethylene oxide sterilization process that strictly follows the ISO 11135 standard, it jointly constructs the product's outstanding reliability and safety in complex endoscopic surgical environments, providing a solid guarantee for disposable aseptic interventional diagnosis and treatment. Attached Figure Description

[0021] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0023] Figure 2 This is a planar schematic diagram of the overall structure of the present invention. Figure 1 ;

[0024] Figure 3 This is a planar schematic diagram of the overall structure of the present invention. Figure 2 ;

[0025] Figure 4 This is an enlarged schematic diagram of the needle tip of the present invention;

[0026] Figure 5 This is an enlarged schematic diagram of the second needle of the present invention. Detailed Implementation

[0027] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses consistent with some aspects of this disclosure as detailed in the appended claims.

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0029] Example 1:

[0030] A novel endoscopic gastrointestinal injection needle, the basic structure of which includes:

[0031] The injection port 1 is made of ABS material. The lower end of the injection port 1 is connected to the handle 2, which is also made of ABS material. The total length after assembly is 150.2 mm and the width is 29.79 mm. The lower end of the handle 2 is coaxially connected to the outer tube 3, which is made of PTFE material. The outer diameter is 16.5 mm, the inner diameter is 2.45 mm, and the length is 2230 mm. The errors of the outer and inner diameters are controlled within ±0.10%, and the length error is controlled within ±0.30%. The inner end of the outer tube 3 is coaxially connected to the inner tube 4, which is made of PEEK material and has an outer diameter of 1 mm. The inner tube 4 has a diameter of 45mm, an inner diameter of 0.95mm, and a length of 2210mm. The outer and inner diameter errors are controlled within ±0.10%, and the length error is controlled within ±0.20%. The lower end of the inner tube 4 is coaxially connected to a needle tube 5 made of 304 stainless steel. The lower end of the needle tube 5 forms two needles, a first needle 6 and a second needle 7, which have a diameter of 0.50-0.53mm and a length of 13mm (error ±1.0%). The second needle 7 has a diameter of 0.60-0.63mm (e.g., 0.615mm) and a length of 13mm (error ±1.0%).

[0032] Example 2:

[0033] A novel endoscopic gastrointestinal injection needle, whose core innovation lies in its precise structural design and excellent performance parameters.

[0034] The injection needle comprises an injection port 1 and a handle 2 as its operating end. The lower end of the handle 2 is connected to an outer tube 3, the inner end of the outer tube 3 is connected to an inner tube 4, and the lower end of the inner tube 4 is connected to a needle tube 5. The lower end of the needle tube (5) is provided with a specially designed double needle head structure. The end face of the handle 2 is provided with a hook body with a surface roughness Ra≤1.6μm, and the inner end of the injection port 1 is provided with a guide groove along the axial direction. The inner wall of the outer tube 3 is provided with a spiral liquid guide groove, and a radial gap of 0.10-0.15mm is maintained between its outer surface and the outer surface of the inner tube 4. The connection between the needle tube 5 and the inner tube 4 is as follows: The end is provided with an annular boss to achieve interference sealing; the first needle 6 has three sharp surfaces, the second needle (7) has four sharp surfaces, and the length of both protruding from the endoscope front end does not exceed 4mm; this injection needle has undergone rigorous performance testing, including: the inner tube 4 can be bent 12° and completely return to its original shape, the needle tube 5 is firmly connected to the outer tube 3, the inner tube 5 is reliably connected to the handle 2, and its sterilization process adopts the ethylene oxide (EO) method, with a pre-adjusted temperature of 10-45℃, a time of ≥120 minutes, and an air removal target pressure of -0.85kgf / cm. 2 Steam injection humidity 50±25% RH, EO gas injection pressure 0.70-0.05 kgf / cm³ 2Concentration 700-800 mg / L, exposure temperature 40±5℃, humidity 50±25%, time 240 minutes, air replacement flushing ≥2 times, pressure -0.85 kgf / cm² 2 The air exposure temperature is 10-40℃ for ≥48 hours, and it complies with ISO11135 standards to ensure sterility assurance level.

[0035] Example 3:

[0036] A novel endoscopic gastrointestinal injection needle has demonstrated excellent ease of operation and safety in clinical applications.

[0037] This injection needle, with its meticulously designed dual-needle structure—needle 6 and needle 7—features three and four sharp edges respectively, along with precise geometric dimensions (e.g., needle 6 has a diameter of 0.515 mm and a length of 13 mm, while needle 7 has a diameter of 0.615 mm and a length of 13 mm). Working in tandem via pneumatic actuation, it easily penetrates tissue during endoscopic gastrointestinal punctures. The needle protrudes no more than 4 mm from the endoscope tip, ensuring no backward movement during insertion. This significantly improves the convenience and stability of the puncture procedure, effectively reducing patient discomfort and complications. This injection needle avoids increased bleeding and tissue damage caused by improper or repeated punctures. Furthermore, its overall structural stability is ensured through a series of precise connection designs (such as the interference fit of the annular boss between the needle tube 5 and the inner tube 4, the tensile strength test requirements between the inner tube and the handle, and the pull-out resistance requirements between the needle tube 5 and the outer tube 3). In addition, its sterilization process strictly follows the supplementary ethylene oxide (EO) sterilization process, involving multiple steps including pre-conditioning, air removal, steam injection, EO gas exposure, air replacement, and final air exposure, meeting ISO11135 standards. This ensures the product reaches an extremely high standard of sterility, providing a solid safety guarantee for clinical applications.

[0038] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A novel endoscopic gastrointestinal injection needle, comprising an injection port (1), characterized in that: The injection port (1) is made of ABS (acrylonitrile-butadiene-styrene). The lower end of the injection port (1) is provided with a handle (2). The handle (2) is made of ABS (acrylonitrile-butadiene-styrene). The length of the injection port (1) and the handle (2) after assembly is 150.2 mm and the width is 29.79 mm.

2. The novel endoscopic gastrointestinal injection needle according to claim 1, characterized in that: The lower end of the handle (2) is provided with an outer tube (3), which is made of PTFE (polytetrafluoroethylene). The outer diameter of the outer tube (3) is 16.5 mm, the inner diameter is 2.45 mm, and the length is 2230 mm. The outer diameter and inner diameter error of the outer tube (3) are within ±0.10%, and the length error is within ±0.30%. The inner end of the outer tube (3) is provided with an inner tube (4), which is made of PEEK (polyetheretherketone). The outer diameter of the inner tube (4) is 1.45 mm, the inner diameter is 0.95 mm, and the length is 2210 mm. The outer diameter and inner diameter error of the inner tube (4) are within ±0.10%, and the length error is within ±0.20%.

3. A novel endoscopic gastrointestinal injection needle according to claim 2, characterized in that: The lower end of the inner tube (4) is provided with a needle tube (5), which is made of 304 stainless steel. The lower end of the needle tube (5) is provided with a first needle (6) and a second needle (7). The diameter of the first needle (6) is 0.50-0.53mm and the length is 13mm, with a length error of ±1.0%. The diameter of the second needle (7) is 0.60-0.63mm and the length is 13mm, with a length error of ±1.0%.

4. A novel endoscopic gastrointestinal injection needle according to claim 3, characterized in that: The first needle (6) and the second needle (7) are driven by air pressure. The first needle (6) has three sharp edges at the cutting edge, and the second needle (7) has four sharp edges at the cutting edge. The length of the first needle (6) and the second needle (7) protruding from the endoscope tip does not exceed 4mm. When performing needle insertion in the gastrointestinal tract, the first needle (6) and the second needle (7) will not retract, thus facilitating the puncture operation and reducing patient pain and bleeding.

5. A novel endoscopic gastrointestinal injection needle according to claim 3, characterized in that: Fix any point A on the needle tube (5), apply weight to point B to bend the inner tube to 12° and hold for 1 minute. After removing the weight, the inner tube should completely return to its original shape. The needle tube (5) has the required pull-out resistance. When a load of 22N is applied in the direction from which the needle tube (5) is pulled out of the needle device, there is no loosening or pull-out at the connection between the needle tube (5) and the outer tube (3). Fix one end of the inner tube (4) to the handle (2), apply a pulling force of not less than 3N in the opposite direction and hold for 15 seconds. There is no breakage or separation at the connection.

6. A novel endoscopic gastrointestinal injection needle according to claims 1 to 5, characterized in that: The packaging quality of the injection needle meets the following requirements: the heat-sealed cover is flat and undamaged, the packaging is tightly sealed and leak-free; the packaging surface is free of foreign matter, stains or defects; the label is firmly attached and does not fall off, and the markings on the label (such as product name, specifications, sterilization mark, etc.) are clear, complete and consistent with the actual product. This device is a disposable sterile product.

7. A novel endoscopic gastrointestinal injection needle according to claim 1, characterized in that: The end face of the handle (2) is provided with a hook body, the surface roughness of the hook body Ra≤1.6μm, so as to avoid the hand slipping during operation. The inner end of the injection port (1) is provided with a guide groove along the axial direction for uniform distribution of the drug liquid during injection.

8. A novel endoscopic gastrointestinal injection needle according to claim 2, characterized in that: The inner wall of the outer tube (3) is provided with a spiral liquid guide groove to reduce the frictional resistance when the inner tube (4) extends and retracts. The radial gap between the outer surface of the inner tube (4) and the inner surface of the outer tube (3) is 0.10-0.15mm to ensure the sliding flexibility of the inner tube (4) in the outer tube (3).

9. A novel endoscopic gastrointestinal injection needle according to claim 3, characterized in that: The end of the needle tube (5) connected to the inner tube (4) is provided with an annular boss. The annular boss is press-fitted with the inner wall of the inner tube (4) to achieve a sealed connection between the needle tube (5) and the inner tube (4). The tips of the first needle (6) and the second needle (7) are rounded to reduce tissue damage during puncture.

10. A novel endoscopic gastrointestinal injection needle according to claims 1 to 9, characterized in that: The sterilization process of the injection needle adopts ethylene oxide (EO) sterilization. The sterilization conditions include: a pre-conditioning stage temperature of 10-45℃ and a time of ≥120 minutes, and a target pressure of -0.85 kgf / cm² during the air removal stage. 2 The humidity during the steam injection stage is 50±25% RH, and the target pressure during the EO gas injection stage is 0.70-0.05 kgf / cm³. 2 The concentration is 700-800 mg / L; the exposure stage temperature is 40±5℃, the humidity is 50±25%, and the exposure time is 240 minutes; the air replacement stage involves ≥2 flushing cycles and a pressure of -0.85 kgf / cm². 2 The air exposure stage temperature is 10-40℃ and the time is ≥48 hours, and the sterilization process must meet the requirements of ISO11135 standard to ensure that the product reaches the sterility assurance level.

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