Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3286—Needle tip design, e.g. for improved penetration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/19—Constructional features of carpules, syringes or blisters
  • A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
  • A61M2205/195—Avoiding coring, e.g. preventing formation of particles during puncture by the needle tip shape

Definitions

• the present invention relates to a medical injection needle, and more particularly to an injection needle suitable for injecting a drug into an inner hemorrhoid tissue.
• Hemorrhoids are a type of hemorrhoids caused by blood circulation disorders (congestion) in the anus.
• the hemorrhoids are divided into an inner hemorrhoid that occurs above the tooth line of the anus and an outer hemorrhoid that occurs at the lower part, and the inner hemorrhoid accounts for 40-60% of the total.
• the problem to be solved is that when a drug is injected into the internal hemorrhoid tissue, there is an injection needle that can distinguish between the internal hemorrhoid tissue and the rectal muscle layer under the tissue due to the difference in piercing resistance. Natsu It is a point.
• the present invention aims to provide an injection needle that can solve the above-mentioned problems, and in order to achieve the object, the feature of the present invention is that the tip of the needle tube is located with respect to its axis.
• the polished surface is used as a blade surface, and the blade surface has a first inclined surface on the base side and a pair of second inclined surfaces on both sides on the front end side. 2
• the angle between the two inclined surfaces is The formation angle, which is an angle, is at a point where the angle is 50 ° to 90 °.
• the first inclination angle may be 8 to 20 °.
• the second inclination angle may be 21 ° to 31 °.
• the blade surface length L1 that is the length of the blade surface in the axial direction may be 1.0 to 5. Omm. Also, the length of the second inclined surface in the axial direction is set as the side cut length L2. In this case, the setting ratio L2ZL1 may be 0.25 to 0.65.
• the injection needle when the injection needle is punctured (pierced) into the internal hemorrhoid tissue, the injection needle with low piercing resistance is erroneously inserted into the rectal muscle layer under the internal hemorrhoid tissue. Because the piercing resistance increases, the drug (medicine solution) can be reliably injected into the internal hemorrhoid tissue, preventing the drug from being inadvertently injected into an inappropriate site such as the rectal muscle layer under the internal hemorrhoid tissue. it can.
• FIG. 1 is a plan view showing an embodiment of the present invention.
• FIG. 2 is a side view of FIG.
• FIG. 3 is a side view of the injection needle of FIG. 2 rotated about its axis.
• FIG. 4 is a side view of the injection needle of FIG. 2 rotated about an axis.
• FIG. 5 is a front view of FIG.
• FIG. 6 is a cross-sectional view taken along line AA in FIG.
• FIG. 7 is a longitudinal sectional view of an inner hemorrhoid model.
• FIG. 8 is a graph showing test results.
• the present invention provides an injection needle capable of discriminating an internal hemorrhoid tissue and a rectal muscle layer under the tissue by a difference in piercing resistance when a drug (medical solution) is injected into the internal hemorrhoid tissue.
• the injection needle of the present invention is formed as follows. That is, the tip portion of the straight tubular needle tube 1 is polished (ground) obliquely with respect to the axial center C to form a sharpened sharpened portion 2 forward, and a portion excluding the sharpened portion 2 of the needle tube 1 Is the main body 3.
• the upper surface of the sharpened portion 2, that is, the obliquely polished surface is the blade surface 4, and the tip is the blade edge 5.
• the blade surface 4 has a first inclined surface (first bevel) 6 on the base side and a pair of second inclined surfaces (second bevel) 7 on both the left and right sides on the distal end side.
• the second inclined surface 7 is formed in a continuous (continuous) shape with respect to the first inclined surface 6, and both the second inclined surfaces 7 are formed in a parallel (continuous) shape in the left-right direction.
• the length L is 13 to 70 mm, and is used as a frequently used value (high frequency value).
• the outer diameter OD is 0.3 ⁇ 1.25mm
• frequently used value (high frequency value) is 0.51mm
• its inner diameter ID is 0.16 ⁇ : L 04mm
• high frequency Values used in (high frequency values) As a result, it is set to 0.29 mm.
• the materials of the needle tube 1 include steel materials including stainless steel, non-ferrous metal materials such as aluminum, copper and titanium, heat resistant materials such as nickel, cobalt and molybdenum, low melting point metals such as lead and tin, gold, silver, Precious metal materials such as platinum and their alloys are used.
• a cylindrical body having a tapered shape toward the distal end or the proximal end, which is not a straight tube alone, or a cylindrical body having a tapered shape from a midway in the axial direction of the blade surface 4 may be used as the needle tube 1, a cylindrical body having a tapered shape toward the distal end or the proximal end, which is not a straight tube alone, or a cylindrical body having a tapered shape from a midway in the axial direction of the blade surface 4 may be used.
• the injection needle is manufactured in the same manner as before. That is, the needle tube 1 is cut to a predetermined length so that the needle tube 1 is not bent, clogged, or abnormally removed, and the needle base cut surface is removed. Next, the first and second inclined surfaces 6 and 7 of the blade surface 4 are formed by polishing as follows. During this polishing process, the needle tube 1 is polished at an appropriate polishing rate and the first and second inclined surfaces 6 and 7 of the blade surface 4 are balanced so that the needle tube 1 is not damaged by the heat during polishing and burrs are not easily generated. It is formed in a well-shaped shape.
• a disc-shaped (cylindrical) rotating turret is placed above the tip of the needle tube 1, and a rotating gun is shown in FIG. 6 (for convenience of explanation in FIG. 6).
• the distance between the stone axis D and the needle tube 1 is smaller than the actual distance.
• the tip of the needle tube 1 is polished by the outer peripheral surface of the rotating grindstone, and first, the blade surface 4 is roughly formed.
• the tip of the blade surface 4 In this case, the rotating mortar is rotated relative to the polishing position force left and right around the axis C of the needle tube 1 (in practice,
• the length L1 in the axial direction of the blade surface 4 is the blade surface length
• the blade surface length L1 is the blade surface length
• the first inclined surface 6 is parallel to the radial direction of the left and right direction (horizontal direction) of the needle tube, and is flat or substantially flat as a whole.
• the angle between the first inclined surface 6 and the axis C is the first inclined angle.
• (First bevel angle) a and the first inclination angle a is 8 to 20 °, preferably 13 ⁇ 2 °.
• the second inclined surfaces 7 on the left and right sides are axisymmetric and have the same shape when viewed from the axial direction.
• a ridge line 9 is formed at the boundary of each second inclined surface 7.
• the ridge line 9 is inclined with respect to the radial direction so as to be higher as it is directed outward in the radial direction.
• the length of the second inclined surface 7 in the axial direction is set as a side-cutting length L2, and the side-setting ratio L2 / L1 force is set to 0.25 to 0.65, preferably set to 0.45 ⁇ 0.2.
• the injection needle is rotated in each direction of the state force shown in FIG. 2, and as shown in FIGS. 3 and 4, when viewed from the side, the left and right second inclined surfaces 7 appear linear.
• the angle between the second inclined surface 7 and the axis C is the second inclination angle (second bevel angle) ⁇ .
• 8 on each of the left and right sides is the same, 21 ° to 31 °, and preferably 26 ⁇ 2 °.
• each second inclined surface 7 faces outward in the radial direction. According to the radial direction It is also inclined.
• the inclination of the second inclined surface 7 and the ridgeline 9 in the radial direction is determined by the diameter of the rotating grindstone and the angle (rotation angle) by which the rotating grindstone is rotated left and right during polishing.
• the formation angle ⁇ which is the angle formed by the second inclined surfaces 7, is 50 to 90 °, preferably 70 to 10 °.
• the rotation angle is 90 ° to 130 ° (45 ° to 65 ° on the left and right), preferably 110 ⁇ 10 ° (55 ⁇ 10 ° on the left and right).
• the syringe needle of the present invention when treating severe internal hemorrhoids with a medicine (chemical solution), the syringe needle of the present invention is connected to a syringe (not shown), and the syringe After the drug is aspirated inside, the needle is punctured (pierced) into the inner hemorrhoid.
• the formation angle of both second inclined surfaces 7 at the tip of the sharpened tip 2 of the injection needle ⁇ force is 0 to 90 °, which is smaller than the conventional 110 °, Since the cross-sectional area on the tip side of the sharpened portion 2 is smaller than before and the inner hemorrhoid itself is soft, the injection needle can be easily punctured (pierced) into the inner hemorrhoid with a small puncture resistance.
• the second inclination angle of the second inclined surface 7 is 21 °. As a result, the piercing resistance is increased. In some cases, the second inclination angle ⁇ of the second inclined surface 7 is set to a value smaller than the above, so that the piercing resistance is not increased.
• the needle is inserted into the inner hemorrhoid, and not only the distal end of the sharpened tip 2 of the injection needle but also the base is inserted into the tissue of the inner hemorrhoid! Since the cross-sectional area of the heel is gradually increased, the piercing resistance of the injection needle is also gradually increased.
• the tip of the sharpened portion 2 of the injection needle is inserted into the rectal muscle layer under the internal hemorrhoidal tissue, and as the second step, the injection is performed.
• the base of the sharp point 2 of the needle will be inserted into the rectal muscle layer under the internal hemorrhoidal tissue.
• the angle of formation of both the second inclined surfaces 7 is 0 to 90 °, and the cross-sectional area of the distal end portion pierced into the rectal muscle layer at the sharpened portion 2 is larger than before. Since it is small, the piercing resistance due to the angle formed by both the second inclined surfaces 7 is small. However, the second inclination angle ⁇ of the second inclined surface 7 is increased to 21 ° to 31 ° so that the piercing resistance due to the second inclination angle ⁇ is large and the rectal muscle layer itself is It may be stiff and increase the needle penetration resistance.
• the first inclined angle a of the first inclined surface 6 is 8 to 20 °, and the second inclined surface 7 Since it is smaller than the inclination angle j8, the piercing resistance due to the second inclination angle is small.
• the formation angle ⁇ force of both the second inclined surfaces 7 is 0 to 90 °, and due to this, the crossing of the distal end portion pierced into the rectal muscle layer at the sharpened portion 2 is performed. The area is smaller than before.
• the first inclined surface 6 is parallel to the radial direction of the left-right direction (horizontal direction) of the needle tube 1, and the first inclined surface 6 is the second inclined surface 7, that is, the first stage. From the first stage. Also increases rapidly. As a result, the rectal muscle layer itself may be hard, and the piercing resistance of the injection needle increases at once.
• the drug is injected into the internal hemorrhoid tissue.
• Test Example 1 in which the present invention was implemented and Comparative Example 1.
• the present invention is not limited to the test examples.
• Outer diameter OD is 0.51mm
• wall thickness is 0.10mm
• blade length L1 is 1.7mm
• first inclination angle ⁇ is 13 °
• 8 is 26 °
• Five injection needles with a surface angle of 0 ° of 70 ° were produced and designated as Test Example 1.
• the outer diameter OD and wall thickness are the same as above
• the blade face length L1 is 2.4 mm
• the first inclination angle ex is 10 °
• the second inclination angle ⁇ is 18 °
• Five injection needles having an angle of 110 ° were manufactured as Comparative Example 1.
• This hemorrhoid model is a disk (column) made of silicone rubber, and the upper disc 11 simulating the inner hemorrhoidal tissue and the It has a lower disk 12 that imitates the myenteric layer and a ring-shaped frame 13 into which the upper and lower disks 11 and 12 are inserted.
• Force that the upper surface of the upper disk 11 is a flat surface
• raised portions 14 projecting upward are formed at intervals in the circumferential direction. The reason for forming the raised portion 14 is to adjust the length of the piercing portion of the injection needle.
• Puncture vertically at a piercing speed of 20 mmZmin measure the piercing resistance with a universal testing machine (Instron: Model No. 5565), and average the measurement results as shown by the solid line in FIG.
• a graph showing the relationship between the insertion amount (mm) and the penetration resistance (N) for the hemorrhoid model of the injection needle was obtained.
• Each injection needle of Comparative Example 1 was measured in the same manner as described above, and as shown by the dotted line in FIG. 8, a graph showing the relationship between the insertion amount (mm) and the penetration resistance (N) for the hemorrhoid model of the injection needle was obtained. It was.
• the insertion amount of the injection needle with respect to the hemorrhoid model is smaller than the straight line A in FIG. 8, that is, the straight line A, and the injection needle is punctured only in the upper disc 11.
• the needle is considered to have been pierced into the internal hemorrhoidal tissue, and the insertion amount of the injection needle into the hemorrhoid model is larger than the straight line A, that is, to the right side of the straight line A,
• the injection needle is also punctured to the lower disc 12 which is connected to only the upper disc 11, it is considered that the injection needle is punctured to the straight intestinal muscle layer.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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• 2005
  • 2005-03-31 JP JP2005102395A patent/JP4826711B2/ja active Active
• 2006
  • 2006-03-30 CN CN2006800099449A patent/CN101151059B/zh active Active
  • 2006-03-30 WO PCT/JP2006/306753 patent/WO2006106880A1/ja active Application Filing
  • 2006-03-30 KR KR1020077022383A patent/KR101291970B1/ko active IP Right Grant

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