WO2022166603A1 - 管固定装置和导管保护装置 - Google Patents

管固定装置和导管保护装置 Download PDF

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Publication number
WO2022166603A1
WO2022166603A1 PCT/CN2022/072971 CN2022072971W WO2022166603A1 WO 2022166603 A1 WO2022166603 A1 WO 2022166603A1 CN 2022072971 W CN2022072971 W CN 2022072971W WO 2022166603 A1 WO2022166603 A1 WO 2022166603A1
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WO
WIPO (PCT)
Prior art keywords
channel
fixing device
catheter
pipe fixing
pipe
Prior art date
Application number
PCT/CN2022/072971
Other languages
English (en)
French (fr)
Inventor
刘庆龙
刘云云
罗雪莉
寸雨曦
Original Assignee
微创神通医疗科技（上海）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 微创神通医疗科技（上海）有限公司 filed Critical 微创神通医疗科技（上海）有限公司
Priority to EP22748882.2A priority Critical patent/EP4272799A4/en
Priority to US18/264,398 priority patent/US20240100295A1/en
Priority to JP2023547378A priority patent/JP2024505307A/ja
Publication of WO2022166603A1 publication Critical patent/WO2022166603A1/zh

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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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/002—Packages specially adapted therefor ; catheter kit packages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment

Definitions

  • the present invention relates to the technical field of medical devices, and in particular, to a tube fixing device and a catheter protection device including the tube fixing device.
  • vascular interventional therapy in order to deliver therapeutic instruments, therapeutic agents and implants to the lesion site, it is necessary to use a combination of sheaths, guide catheters and microcatheters of different sizes to establish intravascular access.
  • a microcatheter and a smaller guide catheter with a softer tip or an intermediate catheter (such as a 5F or 6F catheter) to deliver the desired location to establish access, the catheter must pass through a continuous tortuous vessel.
  • the catheter is usually steam-shaped before it is placed in the blood vessel so that the tip has a certain bending angle.
  • the large lumen guiding catheter or intermediate catheter may become stuck when passing through the ophthalmic artery branch at the siphon curve of the carotid artery, which affects the operation and efficiency of the operation.
  • the tip is steam-shaped and the tip has a certain bending angle, which facilitates its passage through the branch of the ophthalmic artery and improves the operation efficiency.
  • manufacturers of microcatheters, guide catheters or intermediate catheters will increase the angular specifications of the catheters they produce, that is, pre-shape the catheter tip to make the When the catheter leaves the factory, it has a certain bending angle of the head end, that is, the pre-shaping angle.
  • the operator does not need to perform steam shaping operation when using it, but directly inserts the catheter into the blood vessel to complete the construction of the passage during the operation.
  • the soft catheter head-end will gradually creep during the entire shelf life, that is, the head-end bending angle will become smaller over time, until the operator uses it. , the angle of the head end may be too small to satisfy the direct use of the surgeon.
  • the object of the present invention is to provide a pipe fixing device. With respect to the prior art, to solve one or more problems in the prior art.
  • the tube fixing device is provided with a channel for the pre-shaped section of the catheter to pass through, the channel includes a first channel and a second channel, the first channel is used for the straight section of the catheter tip to pass through, the second channel The channel is used for the bending section of the catheter tip to pass through;
  • An angle is formed between the second channel and the first channel.
  • a straight angle or a circular arc angle is formed between the first channel and the second channel.
  • a first deflection angle is formed between the first channel and the second channel, and the first deflection angle is not less than the pre-shaping angle of the pre-shaping end of the catheter.
  • first channel and the second channel form a J-shaped channel.
  • the number of the second channels is at least two.
  • a plurality of the second channels are parallel to each other.
  • the tube fixing device includes at least one fixing portion, the tube fixing device includes at least one fixing portion, and at least a part of at least one of the passages is provided in the fixing portion of the tube fixing device.
  • the tube fixing device further includes a tubular part, the tubular part is detachably connected or integrally connected with the fixing part, the first channel is communicated with the inner cavity, and the inner cavity is located in the tubular part , the first channel communicates with the lumen, the lumen is located in the tubular portion.
  • the diameter of the inner cavity is reduced in diameter or equal in diameter along the axial direction
  • the outer diameter of the tubular portion is reduced in diameter or equal in diameter in the axial direction.
  • the circumferential direction of the channel is closed or one side is circumferentially open.
  • the cross-sectional shape of the channel is any one of a circle, a square, an ellipse, a triangle, a semicircle, and an arcuate shape.
  • the diameter of the channel is reduced or equal in diameter along the axial direction.
  • the channel is opened on one side in the circumferential direction, and the opening is provided with at least one fixing piece, and the fixing piece is axially distributed along the channel, so as to prevent the conduit from passing from the channel through the fixing piece. break away.
  • the width of the fixing piece is 1/3 to 1 of the width of the opening.
  • the pipe fixing device includes a first fixing piece and at least one second fixing piece arranged adjacent to the first fixing piece, and a bayonet is formed between the first fixing piece and the second fixing piece A channel for snap-fitting the catheter pre-shaped end through the bayonet channel.
  • the width of the bayonet channel formed between the first fixing member and the second fixing member is 1 to 3 times the diameter of the pre-shaped end of the catheter.
  • the first fixing member includes at least two parts that are connected or disconnected to each other, and the axes of each part intersect to form a second deflection angle, and the second deflection angle is not less than the pre-shaping angle of the pre-shaping end of the catheter. .
  • the second fixing member is a cylinder
  • the cross section of the cylinder is any one of a circle, an ellipse, a semicircle, and a square.
  • the number of the second fixing parts is 2-10.
  • the material of the pipe fixing device can be selected from any one or a combination of rubber, plastic, metal or a mixture of rubber and plastic.
  • a catheter protection device includes the above-mentioned pipe fixing device and a catheter protection tube.
  • pipe fixing device and the conduit protection pipe are integrally connected or detachably connected.
  • the conduit protection device further includes a lining plate, and the pipe fixing device is connected or separated from the lining plate.
  • the tube fixing device and the head end of the catheter protection tube are arranged continuously or at intervals.
  • conduit protection tube is a coiled tube or a straight tube.
  • the pipe fixing device of the present invention has a first channel and a second channel, the first channel is used to facilitate the passage of the straight section of the catheter head section, and the second channel is used for the bending section of the catheter head section to pass through, thereby It ensures that the angle of the pre-shaped end of the catheter is maintained for a long time and does not shrink, so that the operator can take out the catheter and use it directly and place the catheter into the lesion site without steam plasticizing the catheter, which reduces the preparation time before surgery.
  • the present invention provides that the number of the second channels is set to at least two, so that the present invention can ensure that it is compatible with pre-shaped catheters of different lengths, and can be performed according to pre-shaped catheters of different lengths. Adjust to a suitable position.
  • the tube fixing device avoids additional damage to the pre-shaped catheter, increases the lifespan of the pre-shaped catheter, avoids creep of its head end, and improves the operation efficiency.
  • FIG. 1 shows a schematic structural diagram of a pipe fixing device according to an embodiment of the present invention.
  • FIG. 2 shows a side view of a pipe fixing device in the A direction according to the embodiment of the present invention.
  • Fig. 3 shows an axonometric view of a pipe fixing device according to an embodiment of the present invention.
  • FIG. 4 is a schematic diagram showing the extension of the first channel to all the tubular parts in a tube fixing device according to an embodiment of the present invention.
  • Fig. 5 shows a side view of the tubular part in the B direction of a tubular fixing device according to an embodiment of the present invention.
  • Fig. 6 is a schematic diagram showing the extension of the first channel to a part of the tubular part in a pipe fixing device according to an embodiment of the present invention.
  • FIG. 7 shows a schematic structural diagram of a pipe fixing device with a J-shaped channel in Embodiment 1 of the present invention.
  • FIG. 8 shows a schematic structural diagram of the second pipe fixing device according to the embodiment of the present invention.
  • FIG. 9 shows a schematic structural diagram of a three-pipe fixing device according to an embodiment of the present invention.
  • Fig. 10 is a schematic diagram showing the fixing of the conduit protection tube and the lining plate in the four-tube fixing device according to the embodiment of the present invention
  • FIG. 11 shows a schematic structural diagram of the four-pipe fixing device according to the embodiment of the present invention.
  • Fig. 12 shows a side view of the four-pipe fixing device in the C direction according to the embodiment of the present invention.
  • Fig. 1 the end of the patient, the term “distal” is usually the end close to the patient's lesion. Taking Fig. 1 as an example, the right side of Fig. 1 is the proximal end, and the left side of Fig. 1 is the distal end.
  • the present invention mainly provides a tube fixing device, the tube fixing device is mainly installed at the distal end of the catheter protection tube 4, and the catheter protection tube 4 is usually in the shape of a coiled disk [please refer to FIG. 10 for this shape] or unfolded Straight, the catheter is usually installed in the lumen of the catheter protection tube 4 before leaving the factory to avoid damage, and the pre-shaped end of the catheter will extend out of the distal end of the catheter protection tube 4 and be connected with the tube fixing device.
  • the tube fixing device can be outer or inner sleeve on the catheter protection tube 4, and the tube fixing device can adjust the length of the outer sleeve or inner sleeve on the catheter protection tube along the axial direction of the catheter protection tube 4; or The tube fixing device may not be connected to the catheter protection tube 4 , and may be placed close to or away from the distal end of the catheter protection tube 4 .
  • the tube fixing device of the first embodiment is a first structure that is sleeved with the pre-shaped end of the catheter, and the first structure can be sleeved or sleeved with the distal end of the catheter protection tube 4 .
  • the first structure includes a fixed part 2 and a tubular part 1 connected with the fixed part 2 , wherein the tubular part 1 is used for the passage of the catheter, and the tubular part 1 can also be used for the distance from the catheter protection tube 4 .
  • the fixed part 2 is used for fixing the pre-shaping angle of the pre-shaping end of the catheter, and the pre-shaping angle refers to the angle at which the head end deviates from the extending direction of the main body of the catheter after pre-shaping.
  • tubular part 1 and the fixing part 2 are detachably connected or integrally connected, wherein the tubular part 1 and the fixing part 2 can be integrally formed by injection molding or bonding, as described in the first embodiment.
  • the tubular part 1 and the fixing part 2 are integrally connected.
  • tubular portion 1 The specific structure of the tubular portion 1 is described below as follows:
  • the tubular part 1 is any one of a cylinder, a truncated cone, a triangular prism or a cuboid having an inner cavity 100 , wherein the cross-sectional shape of the inner cavity 100 is preferably a circle, and the inner cavity 100 is preferably circular.
  • the diameter of the cavity 100 is preferably 2 mm to 8 mm, and the axial length of the tubular portion 1 is preferably 10 mm to 100 mm.
  • the cross section of the inner cavity 100 is any one of a circle, a square, an ellipse, a triangle, a semicircle, an arc, a polygon or other irregular shapes.
  • the diameter of the lumen 100 is equal along the axial direction
  • the outer diameter of the tubular part 1 is constant along the axial direction
  • the diameter of the lumen 100 in the tubular part 1 is the same as the diameter of the catheter
  • the outer diameter of the protection tube 4 is matched, and the proximal end of the tubular part 1 can be overlaid on the distal end of the catheter protection tube 4 , or can be arranged spaced apart from the catheter protection tube 4 .
  • the axial length of the tubular part 1 in the tube fixing device of the first embodiment is 20 mm, the cross section of the inner cavity 100 is selected as a circular inner cavity, the tubular part 1 is selected as a cuboid, the cross section of the cuboid is square, and the single The side length is 7.3mm, and the diameter of the circular cavity is 5.7mm; it should be noted that, as shown in FIG. A square with a circular arc; in some other embodiments, the tubular part 1 may be a triangular prism with rounded corners, a cuboid or a triangular prism without rounded corners.
  • the tubular portion 1 is detachably sheathed on the outer side of the distal end of the catheter protection tube 4 .
  • the cross-sectional shape of the lumen 100 of the tubular part 1 matches the cross-sectional shape of the distal end of the catheter protection tube 4 .
  • the cross-sectional shape of the tubular part 1 is the same as that of the distal end of the catheter protection tube 4 .
  • the cross-sectional shape of the inner cavity is matched.
  • the outer diameter of the tubular portion 1 may be gradually reduced from the proximal end of the tubular portion 1 to the distal end of the tubular portion in the axial direction, or the outer diameter of the tubular portion 1 may be axially reduced from the distal end of the tubular portion 1 It is gradually reduced toward the proximal end, and the ratio of the difference between the outer diameter of the proximal end and the outer diameter of the distal end of the tubular portion 1 is selected to be 0-50%.
  • the diameter of the lumen 100 in the tubular portion 1 may also be reduced in diameter, but the minimum diameter of the reduced diameter of the lumen 100 may also be sufficient for a catheter to pass through.
  • the fixing part 2 has a first socket part for passing the pre-shaped end of the catheter.
  • the shape of the fixed portion 2 is any one of a cuboid, a cylinder, an elliptical cylinder or a triangular prism, and the height of the fixed portion 2 is 2 mm to 10 mm.
  • the unilateral side length, the diameter of the circle obtained from the cylindrical section, the long axis and the short axis of the ellipse obtained from the elliptical cylinder section, and the unilateral length of the triangle obtained from the triangular prism section are all 10mm-50mm.
  • the fixing part 2 in the first embodiment is a rectangular parallelepiped with rounded corners, the rounded corners are arranged at the vertices of the rectangular parallelepiped, and the length, width and height of the rectangular parallelepiped are 18mm*15mm*4mm respectively.
  • the fixed portion may also be a tubular structure, the inner diameter of the tubular structure is equal in diameter or variable in diameter along the axial direction, and the outer diameter of the tubular body is equal in diameter along the axial direction or variable diameter.
  • the first socket part refers to a channel opened in the fixing part 2
  • the proximal end of the channel is opened at the proximal end of the fixing part 2
  • the channel The distal end of the channel is formed in the fixed part 2 with a certain depth, wherein the depth of the channel is 1mm-5mm, and the width is 1mm-5mm.
  • the mouth of the proximal end of the channel is formed on the proximal end surface of the fixing part 2
  • the distal end of the channel extends toward the distal end of the fixing part 2 to a certain depth
  • the depth of the channel 200 is 3.8 mm
  • the width of the channel 200 is also 3.8mm.
  • the distal end of the channel can also be formed in the fixing portion 2 and pass through the fixing portion 2, as long as the pre-shaped end of the catheter can be fixed.
  • the inner diameter of the channel may also be reduced in diameter relative to the fixed portion 2 in the axial direction, and the outer diameter of the fixed portion 2 may also be reduced in diameter in the axial direction. This embodiment is further described in the second embodiment.
  • the channel includes a first channel 2001 and a second channel 2002 , there is a deflection angle between the first channel 2001 and the second channel 2002 , and the deflection angle is an arc angle , that is, the deflection angle has an arc angle transition, the first channel is used for the straight section of the catheter head to pass through, and the second channel is used for the curved section of the catheter head to pass through.
  • the length of the first channel 2001 is 3 mm ⁇ 30 mm
  • the total length of the first channel 2001 and the second channel 2002 is 10 mm ⁇ 50 mm.
  • An included angle is formed between the first channel 2001 and the second channel 2002, and the included angle is specifically a first deflection angle ⁇ , the first deflection angle ⁇ is 5° to 180°, preferably the first deflection angle ⁇ The value is not less than the angle at which the tip of the catheter is pre-shaped.
  • the length of the first channel 2001 is 10 mm
  • the common length of the first channel 2001 and the second channel 2002 is 17 mm
  • the first channel 2001 is opposite to the second channel 2001.
  • the first deflection angle ⁇ of the channel 2002 is 30°.
  • the first deflection angle ⁇ of the first channel 2001 relative to the second channel 2002 is 5° ⁇ 180°, such as 5°, 15°, 45°, 60°, 90°, 120° , 150°, 180°.
  • the second channel 2002 further has a curved section, and the curved section forms a channel formed by connecting the first channel 2001 and the second channel 2002 to form a “J” shape.
  • the channel is circumferentially closed or one side is circumferentially open.
  • one side of the channel is circumferentially opened, and the opening has at least one fixing device.
  • a piece 201, the fixing piece 201 is used to prevent the catheter 6 from falling out of the channel.
  • the shape of the fixing pieces 201 is any one of an ellipse, a triangle, and a semicircle.
  • the fixing pieces 201 are distributed at intervals along the axial direction of the channel, and the number of the fixing pieces 201 is 2-20.
  • the width A1 of the fixing piece 201 is 1/3 to 1 of the opening width A2.
  • the fixing pieces 201 are preferably semicircular, the number of the fixing pieces 201 is three, and the fixing pieces 201 are distributed at intervals along the axial direction of the channel 200 .
  • the width of 201 is 2/3 of the opening width.
  • the front and rear distributions of the fixing pieces 201 are all located in the same plane.
  • the fixing pieces 201 can also be dislocated and arranged in a non-same plane. ;
  • the fixing pieces 201 can be distributed on the same side of the channel opening, or can be distributed on both sides of the channel opening respectively. It only needs to be able to cover the catheter and prevent it from leaving the channel.
  • the first channel 2001 of the channel may also extend to part or all of the tubular part 1 , when the first channel 2001 of the channel extends to the tubular part 1 , the channel The total axial length is 20mm to 150mm.
  • FIG. 4 which is a schematic view of the first channel 2001 extending to the entire tubular portion of the channel
  • FIG. 5 is a side view of the tubular portion in the direction B
  • FIG. 6 is a schematic view of the first channel 2001 extending to part of the tubular portion.
  • the total axial length of the channel is preferably 30 mm.
  • the extension of the first channel 2001 of the above-mentioned channels to part or all of the tubular part 1 can realize that when the length of the catheter 6 extending out of the catheter protection tube 4 is too long, the excessively long catheter 6 can be snapped into the channel extending in the tubular part 1.
  • the first channel 2001 makes it immobile, so that the catheter 6 can be fixed in the first channel 2001 with more length.
  • the tube fixing device includes a tubular part 1 and a fixing part 2.
  • the tube fixing device may only include the fixing part 2.
  • the tube fixing device and the catheter protection tube are Remote separation is set.
  • the fixed part 2 includes one channel, and the channel includes a first channel 2001 and a second channel 2002; in other embodiments, the fixed part 2 may include two or more channels , the single channel includes a first channel 2001 and a second channel 2002; in other embodiments, the fixed part 2 includes at least one channel, and the channel includes a first channel 2001 and at least two second channels 2002 , the number of the second channels 2002 may be 2-20, such as 2, 3, 5, 8, 10, 12, 15, 18, 20, etc.
  • the channels 2002 may or may not be parallel to each other.
  • the fixed portion includes at least one second channel 2002 .
  • the material of the tubular part 1 and the fixing part 2 can be selected from any one or a combination of rubber, plastic, metal or a mixture of rubber and plastic.
  • the plastic material can be any one of polyolefin (PO), polyethylene (PE), and polypropylene (PP).
  • the mixture of rubber and plastic can be any one of thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic polyamide (TPA), and polyamide polyether block copolymer (Pebax).
  • TPE thermoplastic elastomer
  • TPU thermoplastic polyurethane
  • TPA thermoplastic polyamide
  • Pebax polyamide polyether block copolymer
  • the catheter 6 when in use, the catheter 6 is inserted into the catheter protection tube 4 , the catheter pre-shaped end of the catheter 6 is exposed from the distal end of the catheter protection tube 4 , and the exposed catheter pre-shaped end is inserted into the lumen 100 and extend into the second channel 2002 along the first channel 2001 of the channel, thereby using the second channel 2002 of the channel to realize the fixation of the pre-shaped end of the catheter 6, and then inner sleeve the tube protection device that fixes the pre-shaped end of the catheter Or it can be sheathed on the distal end of the catheter protection tube 4 , and at the same time, the tube fixing device can be adjusted to a proper position along the axial direction of the catheter protection tube 4 .
  • the pipe fixing device according to the second embodiment of the present invention is basically the same as that of the first embodiment, and the same parts will not be described again, and only the different points will be described below.
  • the tubular part 1 and the fixing part 2 are integrally connected to form a whole by means of injection molding, wherein the fixing part 2 may be a cylinder (such as a cylinder , triangular prism, cuboid), truncated cone, cone (such as cone), the diameter of the circle obtained from the cross-section of the fixed part 2, the rectangle obtained from the cross-section, or the unilateral side of the triangle obtained from the cross-section.
  • the fixing part 2 may be a cylinder (such as a cylinder , triangular prism, cuboid), truncated cone, cone (such as cone), the diameter of the circle obtained from the cross-section of the fixed part 2, the rectangle obtained from the cross-section, or the unilateral side of the triangle obtained from the cross-section.
  • the length is not greater than the diameter of the tubular part 1 or the length of one side of the side, the diameter of the circle obtained by the cross-section of the fixed part 2, or the rectangle obtained by the cross-section, or the length of the one side of the triangle obtained by the cross-section is 3mm ⁇ 12mm.
  • the tube fixing device also includes a first channel 2001 and a second channel 2002 , wherein the first channel 2001 extends in the tubular portion 1 to form a lumen for the catheter to pass through.
  • the second channel 2002 is provided in the fixed part 2 and is used for passing through the bent section of the catheter head section.
  • the inner diameter of the second channel 2002 is 2 mm to 8 mm
  • the ratio of the diameter of the inner cavity in the tubular part 1 to the outer diameter of the catheter 6 is 1.5:1 to 1:1
  • the length of the fixed part 2 is 10 mm to 10 mm. 50mm.
  • the tubular portion 1 is a tubular body with a circular cross-section, the outer diameter of the tubular body is preferably 3.5 mm, and the tubular portion 1 has an inner cavity, wherein The diameter of the inner cavity is equal in diameter, the diameter of the inner cavity is 2.3 mm, the axial length of the tubular part 1 is 30 mm, and the outer diameter of the tubular part 1 is also equal in diameter in the axial direction.
  • the fixing part 2 also has a second socket part for fixing the pre-shaped end of the catheter, and the second socket part refers to the opening in the fixing part 2 of the second channel 2002 , the outer diameter of the fixing part 2 and the diameter of the second channel 2002 decrease from the proximal end to the distal end of the fixing part 2 .
  • the distal end of the second channel 2002 in the fixing part 2 penetrates the fixing part 2 (in some other embodiments, the distal end of the second channel 2002 may not penetrate the fixing part 2), the second channel The proximal end of 2002 is in contact with the first channel 2001 .
  • the outer diameter of the proximal end of the fixing part 2 is preferably 3mm-12mm, the diameter of the proximal end of the second channel 2002 is preferably 2mm-10mm, the outer diameter of the distal end of the fixing part 2 is preferably 1mm-12mm, and the second channel 2002 The diameter of the distal end is preferably 0.1mm-10mm, and the length of the fixing part 2 is preferably 10mm-50mm.
  • the outer diameter of the proximal end of the fixing part 2 is 3.5mm, and the proximal end of the second channel 2002 The diameter is 2.3mm, the outer diameter of the distal end of the fixing part 2 is 2.0mm, the diameter of the distal end of the second channel 2002 is 0.8mm, and the length of the fixing part 2 is 20mm.
  • the fixed part 2 is deflected relative to the tubular part 1, which means that the fixed part 2 is no longer in the same axial direction as the tubular part 1 as in the first embodiment, and the deflection makes the axial direction of the fixed part 2
  • a deflection angle ⁇ is formed between it and the axial direction of the tubular portion 1, and the deflection angle ⁇ is 5° to 180°.
  • the deflection angle ⁇ is preferably 40°;
  • a first deflection angle is formed between the channel 2001 and the second channel 2002 in the fixed part, the first deflection angle may be the same as or different from the deflection angle ⁇ , preferably the first deflection angle is the same as the deflection angle ⁇ , the first deflection angle It is preferably 40°; in other embodiments, the first deflection angle and/or deflection angle ⁇ may be 5° to 180°, such as 5°, 15°, 45°, 60°, 90°, 120°, 150° °, 180 °.
  • the proximal end of the tubular part 1 can be sheathed or internally sheathed on the distal end of the catheter protection tube 4 ; in other embodiments, the tubular part 1 can be spaced apart from the catheter protection tube 4 .
  • both the tubular part 1 and the fixing part 2 are circumferentially closed tubular; in other embodiments, part or the whole of the tubular part 1 and/or the fixing part 2 may have openings in the circumferential direction.
  • the pre-shaped end of the catheter 6 is inserted from the lumen 10 of the tubular part 1 (in this embodiment, the lumen 100 is the first channel 2001 ) and enters the fixing part 2 In the second channel 2002, until the pre-shaped end of the catheter is completely snapped into the second channel 2002, then the tube fixing device is sheathed on the distal end of the catheter protection tube 4, and can be adjusted back and forth to a suitable position for fixing.
  • the pipe fixing device and the head end of the catheter protection pipe 4 in the third embodiment are detachably arranged and have a space between them.
  • the pipe fixing device is fixedly connected to the lining plate 5 , specifically by glue.
  • glue is used to bond the pipe fixing device to the lining plate 5 by any connection method among bonding, hot-melt welding or snap connection.
  • the proximal end of the tube fixing device may also be inner or outer sleeve and the distal end of the catheter protection tube.
  • the tube fixing device of the third embodiment has the same first channel 2001 and the second channel 2002 as the second embodiment, wherein the first channel 2001 is disposed in the tubular part 1 (in this embodiment, The inner cavity is the first channel 2001), the second channel 2002 has a plurality of and corresponds to each fixed part 2 respectively, and each adjacent second channel 2002 is parallel to each other, wherein the tubular part 1 and the The fixed part 2 is integrally connected to form a whole, the first channel 2001 in the tubular part 1 is used for the straight section of the catheter head to pass through, and the second channel 2002 in the fixed part 2 is used for the bent section of the catheter head. pass through.
  • a plurality of juxtaposed fixing parts 2 are provided on the tubular part 1, the fixing parts 2 are parallel to each other and spaced apart, wherein the fixing parts 2 are deflected with respect to the tubular part 1, and the central axis of the fixing parts 2 is the same as that of the tubular part 1.
  • a deflection angle ⁇ is formed between the central axes of the tubular portion 1, and at the same time, a first deflection angle is formed between the first passage 2001 in the tubular portion 1 and the second passage 2002 in the fixed portion 2, and the first deflection angle
  • the first deflection angle is the same as the deflection angle ⁇ (ie the first channel 2001 is parallel to the central axis of the tubular part 1 and the second channel 2002 is parallel to the central axis of the fixed part 2).
  • the deflection angle ⁇ and/or the first deflection angle are 5° to 180°.
  • the deflection angle ⁇ and the first deflection angle are preferably 60°
  • the fixed The number of the parts 2 is 2 to 20, and in the third embodiment, the number of the fixed parts 2 is preferably 5.
  • the number of the fixed parts 2 or the second channels 2002 may be 2, 3, 8, 10, 12, 15, 18, 20, and so on.
  • the length of the tubular part 1 is 10mm ⁇ 100mm
  • the length of the fixing part 2 is 10mm ⁇ 50mm
  • the distance L1 between the adjacent fixing parts 2 can be 1mm ⁇ 5mm
  • the width of the tubular part 1 The width L3 of L2 and the fixing portion 2 may be the same or different.
  • tubular part 1 and the fixing part 2 are made of the same material as thermoplastic polyamide (TPA).
  • TPA thermoplastic polyamide
  • the materials of the tubular part 1 and the fixing part 2 may also be different.
  • the first channel 2001 and at least one second channel 2002 may be formed by several protrusions in different directions.
  • the catheter 6 When used in packaging, the catheter 6 is installed in the catheter protection tube 4 and protrudes from the distal end of the catheter protection tube 4 and into the lumen (not shown) of the tubular part 1, and the corresponding position of the fixing is selected according to the length of the catheter 6
  • the second channel 2002 of the part 2 that is, the pre-shaped end of the catheter can be selectively inserted into the second channel 2002 of any fixed part 2, and the pre-shaped end of the catheter can be fixed after being snapped into the second channel 2002, and then
  • the whole pipe fixing device can be adhered to the opening 502 of the lining plate 5 by glue.
  • the tube fixing device in the fourth embodiment is also disposed at the distal end of the catheter protection tube 4 , and the tube fixing device also has a first channel 2001 and a second channel 2002 .
  • the pipe fixing device includes a first fixing member 301 connected to each other and a second fixing member 302 disposed adjacent to the first fixing member 301 , wherein the number of the second fixing member 302 is not limited
  • the one described in the fourth embodiment of the present invention may be one or more than one, such as 3, 5, 8, and so on.
  • a bayonet channel 303 is formed between the first fixing member 301 and the second fixing member 302 , for clamping and fixing the pre-shaped end of the catheter through the bayonet channel 303 .
  • first fixing member 301 and the second fixing member 302 may also be non-connected or separated from each other, as long as the first fixing member 301 and the second fixing member are ensured
  • a bayonet channel that meets the requirements can be formed between 302, and the distance between the first fixing member 301 and the second fixing member 302 shall not be greater than the outer diameter of the conduit to prevent the conduit from passing therethrough.
  • first fixing member 301 Please continue to refer to FIG. 10 to FIG. 12 , the following first describes the specific structure of the first fixing member 301 as follows:
  • the first fixing member includes a first part 3011 and a second part 3012, the axis of the first part 3011 and the axis of the second part 3012 intersect, so that a second part is formed between the first part 3011 and the second part 3012.
  • the deflection angle ⁇ , the second deflection angle ⁇ is 5° ⁇ 180°.
  • the first fixing member 301 of the fourth embodiment the first fixing member 301 is formed by connecting the first part 3011 and the second part 3012, wherein the first channel is formed by the inner side of the second part 3012 and the second part 3012.
  • the distance formed between the outer sides of the two fixing members 302 , and the second channel is the distance formed between the first portion 3011 and the outer sides of the second fixing member 302 .
  • the second deflection angle ⁇ of the connection between the first part 3011 and the second part 3012 is preferably 90°, and the total length of the first fixing member 301 is 10mm-40mm, the height is 2mm-20mm, and the width is 1mm ⁇ 10mm, the length of the first fixing member 301 in the fourth embodiment is preferably 40mm, the height is preferably 5mm, and the width is preferably 2mm, and the length of the first part 3011 is 1/10 ⁇ 2 of the length of the second part 3012 , preferably, in the fourth embodiment, the lengths of the first part 3011 and the second part 3012 are the same.
  • the connection between the first part 3011 and the second part 3012 may also form an arc
  • the Radians are ⁇ /18(rad)- ⁇ (rad).
  • the first part 3011 and the second part 3012 can also be detachably connected, as long as the axes of the first part 3011 and the second part 3012 intersect and can form a second part The deflection angle is sufficient.
  • the cross section of the second fixing member 302 is any one of a circular, square, semicircular, elliptical, semi-elliptical, arcuate or triangular cylinder, and the cross section obtained is a circle, a semicircle or an ellipse.
  • the diameter of the shape or semi-elliptical shape and the length of one side of the triangle obtained by the cross-section are preferably 1 mm to 10 mm.
  • the second fixing member 302 in the second embodiment is a cylinder with a circular cross-section, and the diameter of the obtained circle in the cross-section is 2mm, and the height of the column is 10mm.
  • the height of the column is 2mm ⁇ 20mm, and the height of the circular body in the fourth embodiment is 10mm.
  • the width of the bayonet channel 303 between the first fixing member 301 and the second fixing member 302 is 1-3 times the diameter of the conduit 6 .
  • the width of the bayonet channel 303 specifically refers to the first distance C1 from the first tangent point A on the second fixing member 302 to the inner side of the second portion 3012 or the second tangent point B to the second fixing member 302 .
  • the second distance C2 on the inner side of the first portion 3011 , the first distance C1 and the second distance C2 are both the minimum distances between the first fixing member 301 and the second fixing member 302 .
  • the first distance C1 and the second distance C2 are equidistant or non-equidistant. When the first distance C1 and the second distance C2 are not equidistant, the first distance C1 may also be along non-equidistant distances.
  • the distance from the longitudinal axis direction to the inner side of the first part 3011, the second distance C2 can also be the distance from the non-horizontal axis direction to the inner side of the second part 3012, as long as the distance is satisfied, the pre-shaped end of the catheter can be fixed That's it.
  • the minimum distance between the first fixing member 301 and the second fixing member 302 that is, the first distance C1 or the second distance C2 is 1.5 mm.
  • the pipe fixing device in the fourth embodiment is not directly connected to the conduit protection tube 4 , the conduit protection tube 4 is detachably connected to the lining plate 5 , and the tube fixing device is movable through the adjustment mechanism It is connected to the lining plate 5 so that the position of the pipe fixing device can be adjusted relative to the lining plate 5 through the adjusting mechanism.
  • the lining plate 5 is made of any one of metal, polymer material or other high hardness materials (such as cardboard), and the outer ring of the lining plate 5 is arranged in the axial direction
  • a plurality of lining plate fixing strips 501, the lining plate fixing strips 501 can be opened and closed relative to the lining plate 5, during the closing process, the lining plate fixing strips 501 can cover part of the conduit protection pipe 4 and be connected with the lining plate 5, Used to fix the catheter protection tube 4 .
  • the lining fixing strip 501 is opened, the fixing of the catheter protection tube 4 can be released.
  • the adjustment mechanism includes an opening 502 and a base 300 movably connected to the opening 502 , the opening 502 is opened on the surface of the backing plate 5 , and the base 300 is used for fixing the first The fixing member 301 and the second fixing member 302 .
  • the base 300 can be any one of a cuboid or a cylinder.
  • the length, width and height of the cuboid base are respectively (20mm-60mm)*(20mm-60mm)*(5mm-40mm)
  • the base 300 is a cylinder
  • the cross-sectional diameter of the cylinder base is 10mm-60mm.
  • the base 300 is preferably a rectangular parallelepiped, and a first side groove 304 and a second side groove 305 are respectively provided on the opposite front and rear sides of the rectangular parallelepiped base.
  • the depth of one side groove 304 and the second side groove 305 are 1mm-10mm, and the width is 1mm-10mm.
  • the depth of the first side groove 304 is 5mm and the width is 2mm.
  • the first side groove 304 and the second side groove 305 are clamped on the two sides of the opening 502 corresponding to the first side groove 304 and the second side groove 305, so that the base 300 can pass through the first side groove 304 and the second side groove 305 move relative to the opening 502 .
  • the base 300 may not be connected to the backing plate through the opening 502 , for example, the base 300 may be directly bonded or clamped to the backing plate, and the backing plate may not be provided with the opening 502 .
  • the materials of the first fixing member 301 and the second fixing member 302 may be the same or different, and the materials may be rubber, plastic, metal, or rubber and plastic. Any one or a combination of the mixtures.
  • the plastic material can be any one of polyolefin (PO), polyethylene (PE), and polypropylene (PP).
  • the mixture of rubber and plastic can be any one of thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic polyamide (TPA), and polyamide polyether block copolymer (Pebax).
  • TPE thermoplastic elastomer
  • TPU thermoplastic polyurethane
  • TPA thermoplastic polyamide
  • Pebax polyamide polyether block copolymer
  • the first fixing member 301 and the second fixing member 302 are made of the same material and are both selected from polyamide polyether block copolymer (Pebax).
  • Fig. 10 to Fig. 12 when packing and using, extend the catheter pre-shaped end of the catheter 6 from the distal end of the catheter protection tube 4, and then snap the catheter pre-shaped end into the first fixing member 301 and the first fixing member 301 and the first In the bayonet channel 303 between the two fixing members 302, the pre-shaped end of the catheter is fixed, and then the pipe fixing device with the pre-shaped end of the catheter is clamped into the opening 502 of the lining plate 5 through the base 300, so The first side groove 304 and the second side groove 305 of the base 300 are respectively clamped with the sides corresponding to the lengths of the opening 502, and then the position of the base 300 on the opening 502 is moved back and forth, so as to satisfy the requirement that the pre-shaped end of the catheter can be fixed. , and the pipe fixing device can be adjusted to a proper position along the axial direction of the catheter protection pipe 4 .
  • the fifth embodiment of the present invention provides a pipe protection device, including, for example, any one of the first to fourth embodiments of the pipe fixing device and a catheter protection pipe, wherein the pipe fixing device and the catheter protection pipe are detachably connected.
  • the tube fixing device and the catheter protection tube may be integrally connected; in other embodiments, the tube fixing device may be provided separately from the catheter protection tube; in other embodiments, the tube fixing device may be connected with the catheter The protection tubes are separated and spaced apart.
  • the conduit protection device further includes a lining plate, and the pipe fixing device is provided separately from the lining plate.
  • the pipe fixing device can be connected with the lining plate, and the connection method includes clipping, bonding, welding, and the like.
  • the conduit protection tube is a coiled tube; in other embodiments, the conduit protection tube is a straight tube.
  • Catheter protection tubes are used to place unused catheters and protect the catheters to prevent them from being damaged.

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Abstract

管固定装置以及包含管固定装置的导管保护装置，管固定装置设有用于导管预塑形段穿过的通道，通道包括第一通道（2001）和第二通道（2002），第一通道（2001）用于导管头端的平直段穿过，第二通道（2002）用于导管头端的弯折段穿过。具有第一通道（2001）、第二通道（2002）的管固定装置能够保证导管预塑型端的角度长期保持并不发生缩小，使术者可取出导管直接使用并将导管置入病变位置，无需再对导管进行蒸汽塑型，减少了术前的准备时间。

Description

管固定装置和导管保护装置 技术领域
本发明涉及医疗器械技术领域，尤其涉及管固定装置以及包含管固定装置的导管保护装置。
背景技术
在血管介入治疗中，为了将治疗器械、治疗试剂和植入物输送到病变位置，需要使用不同型号规格的鞘管、导引导管和微导管组合搭配使用来建立血管内通路。在使用微导管以及较小规格且头端更为柔软的导引导管或中间导管(如规格为5F或6F的导管)向预期位置输送来建立通路时，导管要经过连续迂曲的血管，术者为了操作导管更顺利地通过这些迂曲的血管，通常会在导管置入血管前对其进行蒸汽塑形使头端具有一定弯曲角度。另外，临床使用中，大内腔的导引导管或中间导管在通过颈动脉虹吸弯处的眼动脉分支时会出现卡顿情况，影响手术的操作和效率，术者同样会预先对导管进行头端蒸汽塑形并使头端具有一定弯曲角度，从而有利于其通过眼动脉分支处，提高手术效率。
在争分夺秒的介入手术中，为了给术者提供便捷，增加手术效率，微导管、导引导管或中间导管生产商会对生产的导管增加角型规格，即预先对导管头端进行塑形工序，使导管出厂时即具有一定头端弯曲角度即预塑形角度，术者使用时可不必再进行蒸汽塑形操作，而直接将导管置入血管，完成手术中搭建通路。
但是当具有头端弯曲角度的导管出厂后，在整个货架寿命过程中，柔软的导管头端会逐渐发生蠕变，即头端弯曲角度会随着时间推移而变小，待到术者使用时，头端的角度可能过小，从而无法满足术者直接使用。
发明内容
针对上述现有技术的缺点，本发明的目的是提供管固定装置。相对于现有 技术来说，以解决现有技术中的一个或多个问题。
为实现上述目的，本发明的技术方案如下：
所述管固定装置设有用于导管预塑形段穿过的通道，所述通道包括第一通道和第二通道，所述第一通道用于导管头端的平直段穿过，所述第二通道用于导管头端的弯折段穿过；
所述第二通道与所述第一通道之间形成夹角。
进一步的，所述第一通道与所述第二通道之间形成直线角度或圆弧角度。
进一步的，所述第一通道与第二通道之间形成第一偏转角，所述第一偏转角不小于所述导管预塑形端的预塑形角度。
进一步的，所述第一通道和所述第二通道形成J形通道。
进一步的，所述第二通道的数量为至少两个。
进一步的，多个所述第二通道之间相互平行。
进一步的，所述管固定装置包括至少一固定部分，所述管固定装置包括至少一固定部分，至少一所述通道的至少一部分设置在所述管固定装置的所述固定部分中。
进一步的，所述管固定装置还包括管状部分，所述管状部分与所述固定部分可拆卸地连接或一体连接，所述第一通道与内腔贯通，所述内腔位于所述管状部分中，所述第一通道与内腔贯通，所述内腔位于所述管状部分中。
进一步的，所述内腔的直径沿轴向变径或等径，所述管状部分的外径沿轴向变径或等径。
进一步的，所述通道的周向封闭或一侧周向开口。
进一步的，所述通道的横截面形状为圆形、方形、椭圆形、三角形、半圆形、弓形中的任意一种。
进一步的，所述通道沿轴向变径或等径。
进一步的，所述通道周向一侧开口，所述开口处具有至少一固定片，所述固定片沿所述通道轴向分布，以用于通过所述固定片防止所述导管从所述通道脱离。
进一步的，所述固定片的宽度为所述开口处宽度的1/3～1。
进一步的，所述管固定装置包括第一固定件以及与所述第一固定件相邻设置的至少一个第二固定件，所述第一固定件与所述第二固定件之间形成卡口通道，以用于通过所述卡口通道卡接所述导管预塑形端。
进一步的，所述第一固定件与所述第二固定件之间形成的所述卡口通道的宽度为导管预塑形端直径的1～3倍。
进一步的，所述第一固定件包括互相连接或非连接的至少两部分，每一部分的轴线相交形成第二偏转角，所述第二偏转角不小于所述导管预塑形端的预塑形角度。
进一步的，所述第二固定件为柱体，所述柱体的截面为圆形、椭圆形、半圆形、方形中的任意一种。
进一步的，所述第二固定件的数量为2-10个。
进一步的，所述管固定装置的材料可以选用橡胶、塑料、金属或橡胶和塑料混合物中任意一种或几种的组合。
一种导管保护装置，所述导管保护装置包括上述的管固定装置以及导管保护管。
进一步的，所述管固定装置与所述导管保护管之间一体连接或可拆卸地连接。
进一步的，所述导管保护装置还包括衬板，所述管固定装置与所述衬板连接或分离。
进一步的，所述管固定装置与导管保护管头端连续设置或间隔设置。
进一步的，所述导管保护管为盘管或直管。
与现有技术相比，本发明的有益技术效果如下：
(一)本发明所述管固定装置具有第一通道以及第二通道，利用第一通道便于导管头段的平直段穿过，第二通道用于导管头段的弯折段穿过，从而保证导管预塑形端的角度长期保持并不发生缩小，使术者取出导管直接使用并将该导管置入病变位置，无需再对导管进行蒸汽塑性，减小了术前的准备时间。
(二)进一步的，本发明设置通过将第二通道的数量设置为至少两个，使 得本发明可以保证其与不同长度的预塑形导管适配，且可以根据不同长度的预塑形导管进行调节至合适位置。
(三)进一步的，所述管固定装置避免对预塑形导管造成额外损伤，提高了预塑形导管的寿命，避免其头端发生蠕变，提高了手术效率。
附图说明
图1示出了本发明实施例一管固定装置中结构示意图。
图2示出了本发明实施例一管固定装置在A向的侧视图。
图3示出了本发明实施例一管固定装置的轴测图。
图4示出了本发明实施例一管固定装置中第一通道延伸至全部管状部分的示意图。
图5示出了本发明实施例一管状固定装置中管状部分在B向的侧视图。
图6示出了本发明实施例一管固定装置中第一通道延伸至部分管状部分的示意图。
图7示出了本发明实施例一中通道形成J形的管固定装置的结构示意图。
图8示出了本发明实施例二管固定装置中结构示意图。
图9示出了本发明实施例三管固定装置的结构示意图。
图10示出了本发明实施例四管固定装置中导管保护管与衬板固定的示意图
图11示出了本发明实施例四管固定装置中结构示意图。
图12示出了本发明实施例四管固定装置在C向的侧视图。
附图中标记：
1、管状部分；100、内腔；2、固定部分；200、通道；2001、第一通道；2002、第二通道；201、固定片；300、底座；301、第一固定件；3011、第一部分；3012、第二部分；302、第二固定件；303、卡口通道；304、第一侧边槽；305、第二侧边槽；4、导管保护管；5、衬板；501、衬板固定带；502、开口；6、导管。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图和具体实施方式对本发明提出的管固定装置作进一步详细说明。根据下面说明，本发明的优点和特征将更清楚。需要说明的是，附图采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施方式的目的。为了使本发明的目的、特征和优点能够更加明显易懂，请参阅附图。须知，本说明书所附图式所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整，在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容能涵盖的范围内。
如在本说明书和所附权利要求书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，术语“近端”通常是靠近操作者的一端，术语“远端”通常是靠近患者病变部位的一端。以图1为例，图1的右边为近端，图1的左边为远端。
本发明主要提供一种管固定装置，所述管固定装置主要安装于导管保护管4的远端，所述导管保护管4通常为卷绕的盘状【该形状请参考图10】或展开的平直状，导管在出厂前通常安装在所述导管保护管4的内腔避免损坏，导管预塑形端会伸出所述导管保护管4的远端并与所述管固定装置连接。所述管固定装置可以外套或内套于所述导管保护管4上，且所述管固定装置可沿所述导管保护管4的轴向调节其外套或内套于导管保护管的长度；或者所述管固定装置可以不与导管保护管4连接，紧靠或远离导管保护管4的远端放置。
下面描述管固定装置在实施例一的具体结构：
请参考图1至图6，本实施例一所述管固定装置为与导管预塑形端套接的第一结构，所述第一结构可与所述导管保护管4的远端以内套或外套的方式连接。所述第一结构包括固定部分2以及与所述固定部分2连接的管状部分1，其中所述管状部分1用于导管穿设，所述管状部分1还可以用于与导管保护管4的远端连接，所述固定部分2用于固定导管预塑形端的预塑形角度，所述预塑形角度指的是预塑形后头端偏离导管主体延伸方向的角度。
进一步的，所述管状部分1与所述固定部分2可拆卸地连接或一体连接，其中管状部分1与固定部分2可以通过注塑成型或粘接的方式形成一整体，在本实施例一所述管固定装置中，所述管状部分1与所述固定部分2一体连接。
下面描述管状部分1的具体结构如下：
请参考图1，所述管状部分1为具有内腔100的圆柱体、圆锥台、三棱柱或长方体中的任意一种，其中所述内腔100的横截面形状优选为圆形，所述内腔100的直径优选为2mm～8mm，所述管状部分1的轴向长度优选为10mm～100mm。在其他一些实施例中，所述内腔100的横截面为圆形、方形、椭圆形、三角形、半圆形、弓形、多边形或其他不规则图形中的任意一种。该实施例中，所述内腔100的直径沿轴向是等径的，所述管状部分1的外径沿轴向不变，所述管状部分1中的内腔100的直径与所述导管保护管4的外径相匹配，管状部分1的近端可以外套于导管保护管4的远端，或者，与导管保护管4间隔分离地设置。本实施例一所述管固定装置中管状部分1的轴向长为20mm，内腔100的截面选为圆形内腔，所述管状部分1选为长方体，所述长方体横截面为正方形，单边边长为7.3mm，所述圆形内腔的直径为5.7mm；需要说明的是，如图1所示，管状部分1的长方体中，四个角可以进行圆角处理，其截面为带圆弧的正方形；在其他一些实施例中，管状部分1可以为进行了圆角处理的三棱柱、未进行圆角处理的长方体或三棱柱。
请继续参考图1，所述管状部分1可分离地外套于导管保护管4的远端外侧。进一步的，当所述管状部分1可分离地外套于导管保护管4的远端外周时， 所述管状部分1内腔100的截面形状与导管保护管4远端的截面形状相匹配。相应的，在本发明的其他实施例中，当所述管状部分1可分离的内套于导管保护管4的远端内腔时，所述管状部分1的截面形状与导管保护管4远端内腔的截面形状相匹配。
在本发明的其他实施例中，所述管状部分1的外径沿轴向可以由管状部分1的近端向管状部分的远端逐渐缩小，或者管状部分1的外径沿轴向从远端向近端逐渐缩小，且所述管状部分1近端外径与远端外径之间的差值比例选为0～50％。
在本发明的其他实施例中，所述管状部分1中内腔100的直径也可以是变径的，但变径的所述内腔100的最小直径也可以满足可以供导管穿设即可。
下面描述固定部分2的具体结构如下：
请继续参考图1，所述固定部分2具有第一套接部分用于导管预塑形端穿过。
请继续参考图1，所述固定部分2的形状为长方体、圆柱体、椭圆柱体或三棱柱体中的任意一种，所述固定部分2的高度为2mm～10mm，所述长方体截面所得长方形的单边边长、圆柱体截面所得圆形的直径、椭圆柱体截面所得椭圆形的长轴和短轴、以及三棱柱体截面所得三角形的单边边长均为10mm～50mm。本实施例一所述固定部分2为带有圆角的长方体，所述圆角设置于长方体的顶点处，所述长方体的长宽高分别为18mm*15mm*4mm。
当然，在本发明的其他实施例中，所述固定部分也可以是管体结构，所述管体结构的内径沿轴向等径或变径，所述管体的外径沿轴向等径或变径。
请继续参考图1，本实施例一所述管固定装置中，第一套接部分是指开设在固定部分2的通道，所述通道的近端开设于固定部分2的近端，所述通道的 远端以一定深度成型于固定部分2，其中所述通道的深度为1mm～5mm，宽度为1mm～5mm。具体的，所述通道近端的口部成型于固定部分2的近端端面，所述通道的远端朝向所述固定部分2的远端延伸至一定深度，所述通道200的深度为3.8mm，所述通道200的宽度也为3.8mm。
在本发明的其他实施例中，所述通道的远端也可以成型于所述固定部分2并贯通所述固定部分2,其只要满足可以固定导管预塑形端即可。
在本发明的其他实施例中，所述通道的内径相对于所述固定部分2沿轴向也可以是变径的，所述固定部分2的外径也可以沿轴向是变径的，该种实施例在实施例二中进一步描述。
请继续参考图1，进一步的，所述通道包括第一通道2001和第二通道2002，所述第一通道2001与所述第二通道2002之间具有偏转角，所述偏转角为圆弧角，即偏转角具有圆弧角过渡，所述第一通道用于导管头端的平直段穿过，所述第二通道用于导管头端的弯折段穿过。所述第一通道2001的长度为3mm～30mm，所述第一通道2001和所述第二通道2002的总长度为10mm～50mm。其中所述第一通道2001与第二通道2002之间形成夹角，该夹角具体为第一偏转角度α，所述第一偏转角度α为5°～180°，优选第一偏转角度α的值不小于导管头端预塑形的角度。在本实施例一所述固定部分2中，所述第一通道2001的长度为10mm，所述第一通道2001和第二通道2002的共同长度为17mm，所述第一通道2001相对于第二通道2002的第一偏转角度α为30°。在其他一些实施例中，所述第一通道2001相对于第二通道2002的第一偏转角度α为5°～180°，例如5°、15°、45°、60°、90°、120°、150°、180°。
参考图7，在本发明的其他实施例中，所述第二通道2002还具有弯曲段，所述弯曲段使所述第一通道2001和所述第二通道2002连接构成的通道形成“J”形。
请参考图1和图2，所述通道的周向封闭或一侧周向开口，本发明实施例所述管固定装置中，所述通道一侧周向开口，所述开口处具有至少一固定片201，所述固定片201用于防止导管6从通道中掉出。所述固定片201的形状为椭圆形、三角形、半圆形中的任意一种，所述固定片201沿所述通道的轴向间隔分布，所述固定片201的数量为2～20个，所述固定片201的宽度A1是开口宽度A2的1/3～1。具体的，在本发明实施例一中，所述固定片201优选为半圆形，所述固定片201的数量为3个，各固定片201沿通道200的轴向间隔分布，所述固定片201的宽度是开口宽度的2/3。
在本实施例一所述管固定装置中，所述固定片201前后分布都是位于同一平面内，在本发明的其他实施例中，所述固定片201也可以错位且处于非同一平面内设置；所述固定片201可以分布在通道开口处的同一侧，也可以分别分布在通道开口处的两侧。其只要满足可以覆盖导管不让其脱离通道即可。
相应的，在本发明的其他实施例中，所述通道的第一通道2001也可以延伸至部分或全部管状部分1，当所述通道的第一通道2001延伸至管状部分1时，所述通道的轴向总长度为20mm～150mm。请参考图4为通道的第一通道2001延伸至全部管状部分的示意图，图5为管状部分在B方向的侧视图，图6为第一通道2001延伸至部分管状部分的示意图。请参考图3和图4，当所述通道的第一通道2001延伸至全部管状部分1时，通道的轴向总长度优选为30mm。上述通道的第一通道2001延伸至部分或全部的管状部分1可以实现当伸出导管保护管4的导管6长度过长时，可以将过长的导管6卡入延伸在管状部分1中通道的第一通道2001使其固定不动，从而实现导管6具有更多的长度可固定在所述第一通道2001中。
在该实施例中，所述管固定装置包括管状部分1和固定部分2，在其他一些实施例中，所述管固定装置可以只包含固定部分2，这时，管固定装置与导管保护管的远端分离得设置。
在该实施例中，固定部分2中包括一个通道，所述通道包括一个第一通道2001和一个第二通道2002；在其他一些实施例中，固定部分2可以包括两个或 两个以上的通道，单个所述通道包括一个第一通道2001和第二通道2002；在其他一些实施例中，固定部分2中包括至少一个通道，所述通道包括一个第一通道2001和至少两个第二通道2002，第二通道2002的个数可以为2-20个，例如2个、3个、5个、8个、10个、12个、15个、18个、20个等，多个所述第二通道2002之间互相平行或不平行。在其他一些实施例中，固定部分包括至少一个第二通道2002。
进一步的，所述管状部分1与所述固定部分2的材料可以选用橡胶、塑料、金属或橡胶与塑料的混合物中的任意一种或几种的组合。
其中所述塑料材料可以选用聚烯烃(PO)、聚乙烯(PE)、聚丙烯(PP)中的任意一种。
所述橡胶与塑料的混合物可以选用热塑性弹性体(TPE)、热塑性聚氨酯(TPU)、热塑性聚酰胺(TPA)、聚酰胺聚醚嵌段共聚物(Pebax)中的任意一种。
本发明实施例一所述管固定装置的使用过程如下：
请参考图1和图2，使用时将导管6穿入导管保护管4，导管6的导管预塑形端从导管保护管4的远端露出，将露出的导管预塑形端穿入内腔100并沿通道的第一通道2001伸入至第二通道2002，由此利用通道的第二通道2002实现对导管6的预塑形端进行固定，然后将固定导管预塑形端的管保护装置内套或外套于导管保护管4的远端，同时可以沿着导管保护管4的轴向调节管固定装置至合适的位置。
下面描述管固定装置在实施例二的具体结构：
本发明实施例二所述管固定装置与实施例一基本相同，对于相同部分不再叙述，以下仅对不同点进行描述。
请参考图8，实施例二所述管固定装置中，所述管状部分1和所述固定部分2通过注塑的方式一体连接形成一整体，其中所述固定部分2可以是柱体(如 圆柱体、三棱柱、长方体)、锥台、锥体(如圆锥体)中的任意一种，所述固定部分2截面所得圆形的直径、截面所得长方形、或者截面所得的三角形等图形的单边边长均不大于所述管状部分1的直径或单边边长，所述固定部分2截面所得圆形的直径、或者截面所得长方形、或者截面所得的三角形等图形的单边边长均为3mm～12mm。
请继续参考图8，实施例二所述管固定装置也包括第一通道2001和第二通道2002，其中所述第一通道2001在管状部分1中延伸形成可供导管贯穿的内腔，所述第二通道2002设置于固定部分2并用于导管头段的弯折段穿过。其中所述第二通道2002的内径为2mm～8mm，所述管状部分1中内腔的直径与导管6的外径比值为1.5:1～1：1，所述固定部分2的长度为10mm～50mm。
请继续参考图8，实施例二所述管固定装置中，管状部分1为截面为圆形的管体，所述管体的外径优选为3.5mm，所述管状部分1具有内腔，其中内腔的直径是等径的，该内腔的直径为2.3mm，所述管状部分1的轴向长度为30mm，所述管状部分1的外径沿轴向上也是等径的。
请继续参考图8，实施例二所述管固定装置中，所述固定部分2同样具有第二套接部分用于固定导管预塑形端，所述第二套接部分是指开设在固定部分2的第二通道2002，所述固定部分2的外径以及第二通道2002的直径由所述固定部分2的近端向远端呈递减。所述固定部分2中第二通道2002的远端贯穿所述固定部分2(在其他一些实施例中，第二通道2002的远端也可以不贯穿所述固定部分2)，所述第二通道2002的近端与第一通道2001相接。其中所述固定部分2的近端外径优选3mm-12mm，第二通道2002的近端直径优选2mm-10mm，所述固定部分2的远端外径优选1mm-12mm，所述第二通道2002的远端直径优选0.1mm-10mm，所述固定部分2的长度优选10mm-50mm，在该实施例二中，所述固定部分2的近端外径为3.5mm，第二通道2002的近端直径为2.3mm，所述固定部分2的远端外径为2.0mm，所述第二通道2002的远端直径为0.8mm，所述固定部分2的长度为20mm，在该实施例二中，所述固定部分2相对于管状部 分1偏转设置，该偏转指所述固定部分2不再像实施例一一样是与管状部分1处于同一轴线方向，偏转设置使所述固定部分2的轴线方向与管状部分1的轴线方向之间形成偏转角度β，所述偏转角度β为5°～180°，本实施例二中所述偏转角度β优选为40°；同时在管状部分1中的第一通道2001和在固定部分中的第二通道2002之间形成第一偏转角，所述第一偏转角可以与偏转角β相同或者不同，优选第一偏转角与偏转角β相同，第一偏转角优选为40°；在其他一些实施例中，第一偏转角和/或偏转角度β可以为5°～180°，例如5°、15°、45°、60°、90°、120°、150°、180°。
在该实施例中，管状部分1的近端可以外套或内套于导管保护管4的远端；在其他一些实施例中，管状部分1可以与导管保护管4间隔分离地设置。在该实施例中，管状部分1和固定部分2都为周向上封闭的管状；在其他一些实施例中，管状部分1和/或固定部分2的部分或整体在周向上可以有开口。
请继续参考图8，包装使用时，将导管6的导管预塑形端从管状部分1的内腔10(在该实施例中，内腔100即第一通道2001)穿入并进入固定部分2的第二通道2002中，直至所述导管预塑形端完全卡入第二通道2002内，之后将管固定装置外套于导管保护管4的远端，前后调节至合适位置固定即可。
下面描述管固定装置在实施例三的具体结构：
请参考图9，本实施例三所述管固定装置与导管保护管4的头端可分离的设置并且相互之间具有间隔，所述管固定装置固定连接于衬板5上，具体可以通过胶水粘接、热熔焊接或卡扣连接中的任意一种连接方式，本实施例中采用胶水将管固定装置粘接于衬板5。在与本实施例结构相似的其他实施例中，所述管固定装置的近端也可以内套或外套与导管保护管的远端。
请继续参考图9，实施例三所述管固定装置与实施例二相同均具有第一通道2001以及第二通道2002，其中所述第一通道2001设置于管状部分1(在该实施例中，内腔即第一通道2001)，所述第二通道2002具有多个并分别对应 每一个固定部分2，每个相邻的第二通道2002之间相互平行，其中所述管状部分1和与所述固定部分2一体连接形成一整体，所述管状部分1中第一通道2001用于导管头端的平直段穿过，所述固定部分2中第二通道2002用于导管头段的弯折段穿过。
但该实施例三与实施例二不同如下：
在所述管状部分1上设置多个并列的固定部分2，各固定部分2互相平行并且间隔设置，其中所述固定部分2相对于所述管状部分1偏转，所述固定部分2的中心轴线与所述管状部分1的中心轴线之间形成偏转角γ，同时，管状部分1中的第一通道2001与固定部分2中的第二通道2002之间形成第一偏转角，所述第一偏转角与偏转角γ相同或者不同，优选第一偏转角与偏转角γ相同(即第一通道2001与管状部分1的中心轴线平行，而第二通道2002与固定部分2的中心轴线平行)。
请继续参考图9，进一步的，所述偏转角γ和/或第一偏转角为5°～180°，本实施例三中该偏转角γ和第一偏转角优选为60°，所述固定部分2的数量为2个～20个，本实施例三中固定部分2优选为5个。在其他一些实施例中，固定部分2或者第二通道2002的个数可以为2个、3个、8个、10个、12个、15个、18个、20个等。
所述管状部分1的长度为10mm～100mm，所述固定部分2的长度为10mm～50mm，相邻的所述固定部分2之间的间距L1可为1mm～5mm，所述管状部分1的宽度L2与所述固定部分2的宽度L3可以相同或不同。
进一步的，本实施例三所述管固定装置中，所述管状部分1和所述固定部分2的材料相同均采用热塑性聚酰胺(TPA)。当然在本发明的其他实施例中，所述管状部分1和所述固定部分2的材料也可以是不同的。
在其他的一些实施例中，可以通过方向不同的若干个凸起形成第一通道2001和至少一个第二通道2002。
包装使用时，导管6从安装在导管保护管4中并从导管保护管4的远端伸出并伸入管状部分1的内腔(未示出)，根据导管6的长度选择相应位置的固 定部分2的第二通道2002，即导管预塑形端可以有选择的插入任意一个固定部分2的第二通道2002中，卡入第二通道2002之后使所述导管预塑形端被固定，然后将管固定装置整体通过胶水粘接在衬板5的开口502处即可。
下面描述管固定装置在实施例四的具体结构：
实施例四所述管固定装置同样设置于所述导管保护管4的远端，所述管固定装置同样具有第一通道2001和第二通道2002。
请参考图10至图12，所述管固定装置包括互相连接第一固定件301以及与第一固定件301相邻设置的第二固定件302，其中所述第二固定件302的数量不局限于本发明实施例四所述的一个，其可以是一个或一个以上，例如3个、5个、8个等。所述第一固定件301与所述第二固定件302之间形成卡口通道303，以用于通过所述卡口通道303将所述导管预塑形端卡紧固定。
当然，在本发明的其他实施例中，所述第一固定件301和所述第二固定件302也可以是非连接即互相分离的，其只要保证所述第一固定件301和第二固定件302之间可以形成满足要求的卡口通道即可，同时第一固定件301与第二固定件302之间的间距不得大于导管的外径，避免导管从该处穿过。
请继续参考图10至图12，下面首先描述第一固定件301的具体结构如下：
所述第一固定件包括第一部分3011和第二部分3012，所述第一部分3011的轴线与第二部分3012的轴线相交，使所述第一部分3011与所述第二部分3012之间形成第二偏转角θ，所述第二偏转角θ为5°～180°。在本实施例四所述第一固定件301中，所述第一固定件301由第一部分3011和第二部分3012连接构成，其中上述第一通道是由第二部分3012的内侧边与第二固定件302外侧之间形成的间距，所述第二通道是由第一部分3011与第二固定件302外侧之间形成的间距。所述第一部分3011与所述第二部分3012的连接处的第二偏转角θ优选为90°，所述第一固定件301的总长度为10mm～40mm、高度为2mm～20mm、宽度为1mm～10mm，本实施例四中所述第一固定件301的长度优选为40mm，高度优选为5mm，宽度优选为2mm，所述第一部分3011的长度为第二部分3012 长度的1/10～2，优选的，在本实施例四中所述第一部分3011与第二部分3012的长度相同。
当然，在本发明的其他实施例中，所述第一部分3011与所述第二部分3012在基于轴线相交的情况之下，第一部分3011与第二部分3012的连接处也可以形成弧度，所述弧度为π/18(rad)-π(rad)。
相应的，在本发明的其他实施例中，所述第一部分3011与所述第二部分3012也可以可拆卸地连接，其只要满足第一部分3011与第二部分3012的轴线相交并可形成第二偏转角即可。
请继续参考图10至图12，下面描述第二固定件302的具体结构如下：
所述第二固定件302的截面为圆形、方形、半圆形、椭圆形、半椭圆形、弓形或三角形的柱体中的任意一种，所述截面所得圆形或半圆形或椭圆形或半椭圆形的直径以及截面所得三角形的单边边长优选为1mm～10mm，本实施例二中所述第二固定件302为截面为圆形的柱体，截面所得圆形的直径为2mm，所述柱体的高度为10mm。所述柱体的高度为2mm～20mm，在本实施例四中所述圆形主体的高度为10mm。
请继续参考图10至图12，所述第一固定件301与所述第二固定件302之间卡口通道303的宽度为导管6直径的1～3倍，具体的，请参考图11，所述卡口通道303的宽度具体是指第二固定件302上第一切点A至第二部分3012内侧边的第一间距C1或所述第二固定件302上第二切点B至第一部分3011内侧边的第二间距C2，所述第一间距C1和所述第二间距C2均为第一固定件301与第二固定件302之间的最小间距。所述第一间距C1和所述第二间距C2等距或非等距，当所述第一间距C1和所述第二间距C2非等距时，所述第一间距C1也可以是沿非纵轴方向至第一部分3011内侧边的间距，所述第二间距C2也可以是沿非横轴方向至第二部分3012内侧边的间距，只要满足其中的间距可以固定导管预塑形端即可。本实施例中所述第一固定件301与所述第二固定件302 之间的最小间距即第一间距C1或第二间距C2为1.5mm。
请参考图10至图12，本实施例四所述管固定装置不与导管保护管4直接连接，所述导管保护管4可分离地与衬板5连接，而管固定装置通过调节机构可活动地与所述衬板5连接，使得所述管固定装置通过所述调节机构可以相对于所述衬板5调节位置。
请继续参考图10至图12，所述衬板5采用金属、高分子材料或其他高硬度材料(如硬质纸板)中的任意一种，在所述衬板5的外圈沿轴向设置若干衬板固定带501，所述衬板固定带501可相对于所述衬板5开合，在闭合过程中所述衬板固定带501可覆盖部分导管保护管4并与衬板5连接，以用于将导管保护管4固定。相反的，当打开所述衬板固定带501可解除对其导管保护管4的固定。
请继续参考图10至图12，所述调节机构包括开口502以及可与所述开口502活动连接的底座300，所述开口502开设于衬板5的表面，所述底座300用于固定第一固定件301和第二固定件302。所述底座300可为长方体或圆柱体中的任意一种，当底座300为长方体时，所述长方体底座的长宽高分别为(20mm-60mm)*(20mm-60mm)*(5mm-40mm)，当底座300为圆柱体时，所述圆柱体底座的截面直径为10mm～60mm。本实施例四所述管固定装置中，所述底座300优选为长方体，在所述长方体底座相对的前后两个侧面上分别开设第一侧边槽304和第二侧边槽305，所述第一侧边槽304和第二侧边槽305的深度为1mm～10mm，宽度为1mm～10mm，本实施例四中所述第一侧边槽304的深度为5mm，宽度为2mm，通过所述第一侧边槽304和第二侧边槽305卡在开口502对应第一侧边槽304和第二侧边槽305的两条侧边上，使所述底座300可通过第一侧边槽304和第二侧边槽305相对于开口502活动。
在本发明其他实施例中，所述底座300可以不通过开口502与衬板连接，例如底座300直接粘接或卡接到衬板上，衬板可以不设置开口502。
进一步的，本实施例四所述管固定装置中，所述第一固定件301和所述第二固定件302的材料可以相同或不同，所述材料可以选用橡胶、塑料、金属或橡胶与塑料的混合物中的任意一种或几种的组合。
其中所述塑料材料可以选用聚烯烃(PO)、聚乙烯(PE)、聚丙烯(PP)中的任意一种。
所述橡胶与塑料的混合物可以选用热塑性弹性体(TPE)、热塑性聚氨酯(TPU)、热塑性聚酰胺(TPA)、聚酰胺聚醚嵌段共聚物(Pebax)中的任意一种。
进一步的，本实施例四所述管固定装置中，所述第一固定件301与所述第二固定件302的材料相同并且均选用聚酰胺聚醚嵌段共聚物(Pebax)。
本发明实施例四所述管固定装置的使用过程如下：
请参考图10至图12，包装使用时，将导管6的导管预塑形端从导管保护管4的远端伸出，然后将所述导管预塑形端卡入第一固定件301和第二固定件302之间的卡口通道303中，从而将所述导管预塑形端固定，然后将带有导管预塑形端的管固定装置通过底座300卡入衬板5的开口502中，所述底座300的第一侧边槽304与第二侧边槽305分别与开口502对应长度侧边卡接，然后来回移动底座300在开口502上的位置，以满足即可固定导管预塑形端，又可以沿着导管保护管4的轴向调节管固定装置至合适位置。
本发明实施例五提供一种管保护装置，包括例如实施例一至实施例四中的任意一种管固定装置和导管保护管，管固定装置与导管保护管可拆卸地连接。在其他一些实施例中，管固定装置与导管保护管可以一体连接；在其他一些实施例中，管固定装置可以与导管保护管分离地设置；在其他一些实施例中，管固定装置可以与导管保护管分离且间隔设置。
该实施例中，导管保护装置还包括衬板，管固定装置与衬板分离地设置。在其他一些实施例中，管固定装置可以与衬板连接，连接方式包括卡接、粘接、 焊接等。
该实施例中，导管保护管为盘管；在其他一些实施例中，导管保护管为直管。导管保护管用于放置未使用的导管，保护导管以防止导管被损坏。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (25)

  1. 管固定装置，其特征在于：所述管固定装置设有用于导管预塑形段穿过的通道，所述通道包括第一通道和第二通道，所述第一通道用于导管头端的平直段穿过，所述第二通道用于导管头端的弯折段穿过；
    所述第二通道与所述第一通道之间形成夹角。
  2. 如权利要求1所述的固定装置，其特征在于：所述第一通道与所述第二通道之间形成直线角度或圆弧角度。
  3. 如权利要求1所述的管固定装置，其特征在于：所述第一通道与第二通道之间形成第一偏转角，所述第一偏转角不小于所述导管预塑形端的预塑形角度。
  4. 如权利要求1所述的固定装置，其特征在于：所述第一通道和所述第二通道形成J形通道。
  5. 如权利要求1所述的管固定装置，其特征在于：所述第二通道的数量为至少两个。
  6. 如权利要求5所述的管固定装置，其特征在于：多个所述第二通道之间相互平行。
  7. 如权利要求1所述的管固定装置，其特征在于：所述管固定装置包括至少一固定部分，至少一所述通道的至少一部分设置在所述管固定装置的所述固定部分中。
  8. 如权利要求7所述的管固定装置，其特征在于：所述管固定装置还包括管状部分，所述管状部分与所述固定部分可拆卸地连接或一体连接，所述第一通道与内腔贯通，所述内腔位于所述管状部分中。
  9. 如权利要求8所述的管固定装置，其特征在于：所述内腔的直径沿轴向变径或等径，所述管状部分的外径沿轴向变径或等径。
  10. 如权利要求1所述的管固定装置，其特征在于，所述通道的周向封闭或一侧周向开口。
  11. 如权利要求10所述的管固定装置，其特征在于，所述通道的横截面形 状为圆形、方形、椭圆形、三角形、半圆形、弓形中的任意一种。
  12. 如权利要求10所述的管固定装置，其特征在于，所述通道沿轴向变径或等径。
  13. 如权利要求10所述的管固定装置，其特征在于：所述通道周向一侧开口，所述开口处具有至少一固定片，所述固定片沿所述通道轴向分布，以用于通过所述固定片防止所述导管从所述通道脱离。
  14. 如权利要求13所述的管固定装置，其特征在于：所述固定片的宽度为所述开口处宽度的1/3～1。
  15. 如权利要求1所述的管固定装置，其特征在于：所述管固定装置包括第一固定件以及与所述第一固定件相邻设置的至少一个第二固定件，所述第一固定件与所述第二固定件之间形成卡口通道，以用于通过所述卡口通道卡接所述导管预塑形端。
  16. 如权利要求15所述的管固定装置，其特征在于：所述第一固定件与所述第二固定件之间形成的所述卡口通道的宽度为导管预塑形端直径的1～3倍。
  17. 如权利要求15所述的管固定装置，其特征在于：所述第一固定件包括互相连接或非连接的至少两部分，每一部分的轴线相交形成第二偏转角，所述第二偏转角不小于所述导管预塑形端的预塑形角度。
  18. 如权利要求15所述的管固定装置，其特征在于：所述第二固定件为柱体，所述柱体的截面为圆形、椭圆形、半圆形、方形、弓形、三角形中的任意一种。
  19. 如权利要求15所述的管固定装置，其特征在于：所述第二固定件的数量为2-10个。
  20. 如权利要求1所述的管固定装置，其特征在于：所述管固定装置的材料可以选用橡胶、塑料、金属或橡胶和塑料混合物中任意一种或几种的组合。
  21. 一种导管保护装置，其特征在于：所述导管保护装置包括如权利要求1～20任意一条所述的管固定装置以及导管保护管。
  22. 如权利要求21所述的导管保护装置，其特征在于：所述管固定装置与所述导管保护管之间一体连接或可拆卸地连接。
  23. 如权利要求21所述的导管保护装置，其特征在于：所述导管保护装置还包括衬板，所述管固定装置与所述衬板连接或分离。
  24. 如权利要求21所述的导管保护装置，其特征在于：所述管固定装置与导管保护管头端连续设置或间隔设置。
  25. 如权利要21所述的导管保护装置，其特征在于，所述导管保护管为盘管或直管。
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