WO2022147998A1 - 扩张管、血管鞘装置、血管鞘装置与预扩器的配合结构、预扩器 - Google Patents

扩张管、血管鞘装置、血管鞘装置与预扩器的配合结构、预扩器 Download PDF

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Publication number
WO2022147998A1
WO2022147998A1 PCT/CN2021/107025 CN2021107025W WO2022147998A1 WO 2022147998 A1 WO2022147998 A1 WO 2022147998A1 CN 2021107025 W CN2021107025 W CN 2021107025W WO 2022147998 A1 WO2022147998 A1 WO 2022147998A1
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WO
WIPO (PCT)
Prior art keywords
tube
distal end
expansion tube
sealing
sheath device
Prior art date
Application number
PCT/CN2021/107025
Other languages
English (en)
French (fr)
Inventor
陈晓
刘冰冰
黄韬
张铭宇
李阳
王雪雪
王银燕
Original Assignee
上海翰凌医疗器械有限公司
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
Priority claimed from CN202110019067.XA external-priority patent/CN112642044B/zh
Priority claimed from CN202110019033.0A external-priority patent/CN112717269B/zh
Priority claimed from CN202110019020.3A external-priority patent/CN112717263B/zh
Application filed by 上海翰凌医疗器械有限公司 filed Critical 上海翰凌医疗器械有限公司
Publication of WO2022147998A1 publication Critical patent/WO2022147998A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Definitions

  • the application belongs to the technical field of medical devices, and specifically relates to a dilation tube, a vascular sheath device, a matching structure of a vascular sheath device and a pre-expander, and a pre-expander.
  • the vascular sheath plays an important role in interventional therapy.
  • the vascular sheath device is used to guide the vascular sheath device to expand the skin and muscle tissue and enter the lumen of the epidermal blood vessel, and then the puncture guide wire is taken out, so that the distal end of the vascular sheath device is placed in the blood vessel, thus establishing a The passage from outside the body to the lumen of a blood vessel for the passage of surgical instruments.
  • artificial heart valve replacement surgery generally uses an interventional valve. When the interventional valve enters the human body through the femoral artery and femoral vein, a vascular sheath device is required to establish a channel.
  • the existing vascular sheath device includes a base, a hemostatic valve, a dilation tube and a sheath; the proximal opening of the base is sealed with a hemostasis valve, the distal opening of the base is provided with a sheath, and the dilation tube passes through In the inner hole of the base and the inner hole of the sheath tube, the proximal end of the expansion tube is flared and located outside the proximal end of the base, and the distal end of the expansion tube extends out of the sheath tube.
  • the rigid guide wire when dilating the blood vessel, the rigid guide wire is passed through the hemostatic valve and the inner hole of the dilation tube in turn, and the distal end of the rigid guide wire extends out of the distal end of the dilation tube to guide the entire vascular sheath.
  • the device moves in the blood vessel and waits for it to move in place; the dilation tube extends out of the sheath tube, moves in the blood vessel, exerts a radial expansion force on the blood vessel to expand the inner diameter of the blood vessel, and then the surgical instrument enters the human body through the inner hole of the dilation tube. In vivo, surgery is performed on the lesion site.
  • the diameter of the dilating tube is relatively fixed, and can only dilate a blood vessel corresponding to one disease.
  • the diameter of the device for transvascular sheath valve replacement is generally between 6 mm and 10 mm, while the diameter of the human femoral artery and femoral vein is generally about 4.5 mm to 7.2 mm.
  • the diameter of the dilation tube of the existing vascular sheath device should not be too small for the valve device to pass through; or the size is too large.
  • the existing vascular sheath device is generally customized according to the size of the organ to be passed through to treat different types of diseases and the size of the surgical instrument for passing through.
  • the diameter of the dilation tube is relatively fixed and cannot be adapted to different diameters Effective expansion of blood vessels and passage of surgical instruments of different sizes have the disadvantage of poor overall adaptability.
  • the dilation tube of the vascular sheath device generally includes a main body and a head cap fixed on the distal end of the main body.
  • the head cap of the dilation tube In order to prevent the dilation tube from sliding in the blood vessel and causing damage to the blood vessel wall, the head cap of the dilation tube generally has a smooth conical surface. , the outer and inner diameters of the head gradually decrease from the proximal end to the distal end.
  • the outer diameter and inner diameter of the head cap gradually decrease from the proximal end to the distal end, especially the distal end of the head cap has greater resistance to the surgical instrument, which is easy to cause
  • the surgical instrument cannot smoothly pass through the distal end of the head cap. Even after passing through the distal end of the head cap, it is easy to cause damage to the head of the surgical instrument, which affects the subsequent use of the surgical instrument during the operation.
  • One purpose of the present application is to overcome the defects of the existing vascular sheath device that the diameter of the dilation tube is relatively fixed, cannot effectively dilate blood vessels of different diameters, and can be passed through by surgical instruments of different sizes, resulting in poor overall adaptability.
  • Another object of the present application is to overcome the following defects in the prior art.
  • the resistance received is large, which is inconvenient for the surgical instrument to pass through smoothly, and is easy to cause damage to the head of the surgical instrument. damage, affecting the normal use of surgical instruments.
  • the present application provides an expansion tube, comprising at least one deformation portion distributed along the circumferential direction of the expansion tube, and the first end of any of the deformation portions along the circumferential direction of the expansion tube is bent and distributed in the S direction toward the second end, so as to form an annular shape; the deformed portion can be stretched in the radial direction of the expansion tube to be in an expanded state when subjected to an expansion force in the radial direction of the expansion tube.
  • the above-mentioned expansion tube also includes at least one mounting portion, and the first end and the second end of the deforming portion are respectively connected to the adjacent deforming portions or mounting portions, so that all the deforming portions and mounting portions are connected. circle around.
  • the deformation portion and the installation portion are alternately distributed along the circumferential direction of the expansion tube.
  • all the deformed inner peripheral walls and the inner peripheral walls of the mounting portion are located on the same circumferential surface, and the outer peripheral walls of all the deformed portions and the outer peripheral walls of the mounting portion are located on the same circumferential surface. on the same circumference.
  • the first end of the former deformation part is connected with the second end of the latter deformation part.
  • the deformation portion includes an inner layer section, at least one intermediate section and an outer layer section that are sequentially stacked and distributed from the inside to the outside along the radial direction of the expansion tube; the inner layer section, at least one intermediate section and The outer layer segments are sequentially connected by curved arc segments to bend in the S direction.
  • the deformation portion includes an inner layer section, at least one intermediate section and an outer layer section distributed in layers along the circumferential direction of the expansion tube; the inner layer section, at least one intermediate section and outer layer section are sequentially
  • the deformed portions are distributed in an S-oriented wave line along the circumferential direction of the expansion tube by being connected by bent circular arc segments.
  • the deformation portion is made of deformed material; the deformation portion can be switched between the expansion state and the initial state; in the initial state, the expansion force is cancelled, and the deformation portion expands along the The tube is retracted radially.
  • the present application also provides a vascular sheath device, comprising: a casing; a hemostatic valve, which is sealingly provided on the opening at the proximal end of the casing; The above expansion tube.
  • the above-mentioned vascular sheath device further includes a deformable flexible tube sheathed outside the dilation tube, and the dilation tube tends to maintain the initial state of radial contraction due to the radial binding force of the flexible tube. .
  • vascular sheath device at least part of the mounting portion of the dilation tube and the flexible tube are bonded by glue.
  • the above-mentioned vascular sheath device further includes a head cap provided on the distal end of the dilation tube; at least one first deformation seam is provided on the head cap, and at least one first deformation seam is provided on the head cap. at least one connecting part of the proximal end and/or the distal end of the seam to connect the parts of the head cap on both sides of the first deformation seam; the head cap is connected with the head cap through the first deformation seam The expansion of the deformed portion causes radial expansion.
  • the length of the first deformation seam is not less than the length of the connecting parts.
  • one of the proximal end of the head cap and the distal end of the mounting portion of the expansion tube is provided with a clamping groove extending axially along the expansion tube, and the other is provided with a clamping groove extending axially along the expansion tube.
  • platinum-iridium alloy material is fused on the head cap; A second deformation seam is provided corresponding to the first deformation seam.
  • the outer wall of the head cap is provided with at least one accommodating groove for accommodating glue, so that at least the head cap is in contact with the hose at the accommodating groove.
  • the inner wall is glued and connected; or, a first protrusion is formed between two adjacent grooves on the head cap, a stepped surface is formed between the first protrusion and the head cap, and the distal end of the hose is sleeved on On the first protrusion, the distal end face of the hose abuts on the step surface, and the hose and the first protrusion are fixed by discontinuous adhesive bonding with glue.
  • the outer peripheral wall of the flexible tube is coated with a hydrophilic coating.
  • the expansion tube includes a mounting section and a main body section that are integrally formed from the proximal end toward the distal end; in the initial state without radial expansion force, the deformed portion of the proximal end of the mounting section is in the shape of a In the expanded state, the deformed portion of the main body section is bent and distributed in the S direction, and the installation section is a tapered tube whose outer diameter is gradually reduced from the proximal end to the distal end, and is formed on the proximal end of the main body section by transition; It includes a fixing mechanism arranged on the proximal end of the expansion tube; the fixing mechanism includes a fixing ring inserted into the mounting section, the fixing ring is sleeved outside the distal end of the housing, and the hose The proximal end of the fixing ring is sleeved outside the fixing ring; and a locking member is fitted outside the distal end of the casing,
  • the distal end of the fixing ring is a tapered portion that is matched with the tapered tube, and the tapered portion is provided with a mounting portion suitable for the mounting section on the mounting section. A corresponding embedded mounting slot.
  • the proximal end of the fixing ring is a flared portion facing the housing, and the flared portion is clamped between the housing and the locking member.
  • the locking member is threadedly fitted on the distal end of the housing; and/or at least part of the flexible tube is adhesively connected to the installation section and the fixing ring.
  • At least one third deformation seam extending along the axial direction is provided on the distal end of the fixing ring.
  • the inner wall surface of the distal end of the fixing ring is flaring from the proximal end toward the distal end.
  • the hemostatic valve includes at least one first seal; the first seal includes a first annular base, which is formed on the distal end of the first annular base and faces the annular base At least one sealing protrusion protruding from the distal end of the sealing protrusion, the end surface of the sealing protrusion is provided with a first sealing channel; the two side walls of the sealing protrusion are sloped, and the slope is formed by the sealing protrusion.
  • the distal end of the sealing protrusion is inclined toward the root of its proximal end, and the two side walls of the sealing protrusion are pressed by the pressure of the medium at the distal end thereof, so as to force the first sealing channel to close.
  • the slope surface includes a first inclined surface and a second inclined surface, the proximal end of the first inclined surface is connected with the distal end of the second inclined surface, and the first inclined surface is connected to the distal end of the second inclined surface.
  • the distal end of the inclined surface is connected to the end surface of the sealing protrusion, the proximal end of the second inclined surface is formed on the first annular base, and the inclination of the first inclined surface is relative to the end surface of the sealing protrusion The angle is different from the inclination angle of the second inclined surface with respect to the end surface of the sealing protrusion.
  • the first sealing channel is a straight-line seam, a cross-shaped seam, or a rice-shaped seam.
  • the sealing protrusion includes four branch protrusions, the branch protrusions form a cross protrusion, and the two side walls of each branch protrusion are respectively a slope, and the cross The first sealing channel on the raised end face constitutes a cross slit.
  • the hemostatic valve further comprises a second sealing member which is stacked and distributed with the first sealing member;
  • the second sealing member comprises a second annular base, which is formed on the second annular a second protrusion in the inner hole of the base body, the second protrusion protrudes toward the distal end of the second annular base body, a second sealing channel is provided on the second protrusion, and the second sealing channel communicating with the first sealing channel.
  • the second sealing member further includes at least one first reinforcing rib, one end of the first reinforcing rib is fixed on the outer wall surface of the distal end of the second protrusion, and the other is fixed on the outer wall surface of the distal end of the second protrusion. One end is fixed on the inner wall surface of the second annular base body.
  • the hemostatic valve further comprises at least one sealing gasket which is laminated and sandwiched between the first sealing member and the second sealing member, and a third sealing channel is provided on the sealing gasket, The third sealing channel, the first sealing channel and the second sealing channel are distributed on the axis of the expansion tube.
  • the third sealing channel includes a through hole and/or at least one cutting groove, and when the third sealing channel includes a through hole and at least one cutting groove, the at least one cutting groove At least one second reinforcing rib is disposed on the outer periphery of the through hole and communicated with the through hole; and/or the distal end face and/or the proximal end face of the sealing gasket is provided.
  • the third sealing channel has at least two cutting grooves, wherein at least one cutting groove is distributed on the distal end face of the sealing gasket, and at least one cutting groove is distributed on the outer surface of the sealing gasket.
  • Proximal end surface; or, the third sealing channel includes a cross-shaped cutting groove provided on the distal end surface of the sealing gasket and an "X"-shaped cutting groove provided on the proximal end surface or a cross-shaped cutting groove provided on the distal end surface of the sealing gasket.
  • the "X"-shaped cutting groove and the cross-shaped cutting groove on the proximal end face, the cross-shaped cutting groove and the "X"-shaped cutting groove together make the cutting groove have a rice-shaped structure, and also include a cutting groove with the rice-shaped structure.
  • a channel that communicates and is located in the middle of the cutting groove of the rice-shaped structure; or, the third sealing channel is the same as the second sealing channel.
  • the hemostatic valve comprises: at least two gaskets; and a first support ring arranged between two adjacent gaskets and/or a first support ring arranged between the gasket and the A second support ring between the second seals.
  • the proximal end and the distal end of the outer peripheral wall of the first support ring are respectively provided with a third inclined surface; and/or, a guide cylinder is further provided on the distal end of the second annular base of the second seal, and the second protrusion is located in the guide cylinder; the second support ring sleeved outside the guide cylinder, the proximal end of the second support ring abuts on the distal end surface of the second annular base body, and the distal end surface of the second support ring is provided with abutting and mating with the beveled edge at the outer periphery of the sealing gasket and/or, the proximal end surface of the first sealing member is provided with a fifth inclined surface which is matched with the bevel at the outer periphery of the adjacent gasket.
  • the hemostatic valve further comprises a base; a first annular step is arranged in the inner hole of the outer casing; the base has an annular flange, and the base is tightly embedded in the outer casing At the proximal opening of the housing, the annular flange is hooked on the proximal end face of the housing; at least the first sealing member is tightly clamped between the distal end face of the base and the first annular step.
  • the outer peripheral wall of the base is provided with at least one snap-on protrusion that protrudes radially
  • the outer shell is provided with a one-to-one snap-fit for the snap-on protrusions.
  • a snap hole, and the base and the shell are connected by inserting the snap protrusion into the snap hole.
  • a connecting channel is provided on the side wall of the outer casing; it also includes a three-way valve, and the three-way valve and the connecting channel are connected by a first pipeline.
  • the present application also provides a matching structure of a vascular sheath device and a pre-expander, including: the above-mentioned vascular sheath device, wherein a head cap is provided on the distal end of the expansion tube; The second head on the distal end of the pre-expanded tube, the outer diameter of at least part of the second head is larger than the inner diameter of the distal end of the head cap of the expansion tube, the pre-expanded tube and the first The two heads are adapted to slide in the expansion tube to spread the head cap of the expansion tube in the radial direction.
  • the outer diameter of the second head is larger than the inner diameter of the head cap of the expansion tube.
  • the outer diameter of the pre-expanded tube is smaller than the outer diameter of the second head, and is smaller than the inner diameter of the expansion tube when the expansion tube is not radially expanded.
  • the at least part of the second head is provided with a return channel extending along the axial direction thereof, and both the proximal end and the distal end of the return channel are open.
  • the return channel is a radially inwardly recessed return groove provided on the at least part of the outer peripheral wall.
  • the second head includes a first segment in the shape of a conical ring, and the outer diameter of the middle portion of the first segment is larger than the outer diameters of both ends thereof; the return passage is provided at least in the on the middle of the first section; the proximal end of the first section is connected with the distal end of the pre-expanded tube.
  • the second head further includes a second segment formed on the proximal end of the first segment, and the proximal end of the first segment passes through the proximal end of the second segment
  • the outer diameter of the second section is smaller than or equal to the outer diameter of the proximal end of the first section.
  • the present application also provides a pre-expander, comprising a pre-expanded tube, and a second head disposed on the distal end of the pre-expanded tube, at least part of the second head has an outer diameter greater than that of the expansion tube
  • the inner diameter of the distal end of the head cap, the pre-expanded tube and the second head are adapted to slide in the expansion tube to spread the head cap of the expansion tube in a radial direction.
  • the outer diameter of the second head is larger than the inner diameter of the head cap of the expansion tube.
  • the outer diameter of the pre-expanded tube is smaller than the outer diameter of the second head, and is smaller than the inner diameter of the expansion tube when the expansion tube is not radially expanded.
  • the at least part of the second head is provided with a return channel extending along the axial direction thereof, and both the proximal end and the distal end of the return channel are open.
  • the return channel is a radially inwardly recessed return groove provided on the at least part of the outer peripheral wall.
  • the second head includes a first section in the shape of a conical ring, and the outer diameter of the middle of the first section is larger than the outer diameter of both ends; on the middle of the first section; the proximal end of the first section is connected with the distal end of the pre-expanded tube.
  • the second head further includes a second segment formed on the proximal end of the first segment, and the proximal end of the first segment passes through the proximal end of the second segment.
  • the end is sleeved outside the distal end of the pre-expanded tube; the outer diameter of the second section is smaller than or equal to the outer diameter of the proximal end of the first section.
  • the expansion tube provided by the present application comprises at least one deformed portion distributed along its circumferential direction, and the first end of any of the deformed portions along the circumferential direction of the expansion tube is bent and distributed in the S direction toward the second end thereof, so as to form an annular shape; the deformed portion can be stretched in the radial direction of the expansion tube to be in an expanded state when subjected to an expansion force in the radial direction of the expansion tube.
  • the deformation part since the first end of the deformation part along the circumferential direction of the expansion tube is bent and distributed in the S direction toward the second end, the deformation part is in the S direction when the deformation part is not subjected to the radial expansion force of the expansion tube.
  • the outer peripheral wall of the surgical instrument exerts a radial expansion force on the inner wall of the deformed part, and is subject to this
  • the expansion force, the first end and the second end of the deformed part are continuously spread along the outer peripheral wall of the surgical instrument in a direction away from each other, so that the inner hole of the expansion tube is radially stretched, and the diameter of the inner hole of the expansion tube is increased.
  • the expansion tube has a small outer diameter in the initial state, and can be embedded in blood vessels of different sizes, so as to effectively expand blood vessels of different sizes and improve the Adaptability to the use of dilation tubes.
  • the deformation part is made of deformed material; the deformation part can be switched between the expansion state and the initial state; in the initial state, the expansion force is cancelled, and the deformation part is along the diameter of the expansion tube
  • the first end and the second end of the deformed part contract toward each other under the reset action of its own material, so as to return to the initial state.
  • the inner diameter of the wrapped part of the surgical instrument will increase with the movement of the instrument, and the inner diameter of the unwrapped part will return to its original size, so that the diameter of the inner hole of the expansion tube can be switched between expansion and contraction, so that the expansion tube is suitable for different Instruments and vessels of different diameters reduce vascular complications and can be reused.
  • the peripheral walls of all deformed parts and the peripheral wall of the installation part are located on the same circumference; it is ensured that the dilation tube can be inserted into the blood vessel and move within the blood vessel without scratching the blood vessel wall.
  • the vascular sheath device provided by the application includes the above-mentioned dilation tube, so that the vascular sheath can effectively dilate blood vessels of different diameters, and is passed through for the surgical instruments of different sizes to improve the adaptability of the vascular sheath device, not only In valve replacement surgery, the femoral artery and femoral vein can be effectively expanded for the passage of surgical instruments; it can also effectively expand blood vessels of other sizes for the passage of corresponding surgical instruments.
  • the vascular sheath device further comprises a deformable flexible tube sheathed outside the dilation tube, the dilation tube tends to maintain an initial state of radial contraction due to the radial binding force of the flexible tube .
  • the flexible tube is arranged so that the smooth outer wall surface of the flexible tube is in contact with the blood vessel wall, preventing Causes damage to blood vessel walls.
  • a hydrophilic coating is applied on the outer peripheral wall of the flexible tube to lubricate the outer peripheral wall of the flexible tube, so as to form a smooth surface for contacting with the blood vessel wall.
  • the matching structure of the vascular sheath device and the pre-expander provided by the application includes the above-mentioned vascular sheath device, wherein the distal end of the expansion tube is provided with a head cap; and the pre-expander, including the pre-expanded tube and the The second head on the distal end of the pre-expanded tube, the outer diameter of at least part of the second head is larger than the inner diameter of the distal end of the head cap of the expansion tube, the pre-expanded tube and the second head are The head is adapted to slide inside the dilation tube to spread the head cap of the dilation tube in the radial direction.
  • the pre-expanded tube of the pre-expander is used first.
  • the second head slides in the expansion tube, at least part of the second head passes through the distal end of the head cap of the expansion tube, and the head cap of the expansion tube is radially stretched, and then the pre-expander is removed from the expansion tube
  • the radial force of the surgical instrument on the head cap is small, which facilitates the surgical instrument to pass through the head cap and protects the head of the surgical instrument.
  • the at least part of the second head is provided with a backflow channel extending along its axial direction, and the proximal end and the distal end of the backflow channel are provided. The ends are open.
  • the second head of the pre-expander pre-expands the head cap of the dilation tube
  • the second head is located in the blood vessel wall outside the distal end of the head cap;
  • the blood flows into the gap between the expansion tube and the pre-expanded tube on the proximal side of the second head, and the proximal end of the expansion tube is provided with a hemostatic valve
  • the second head is provided with a return channel , so that the blood on both sides of the return channel is connected, that is, the blood pressure in the above-mentioned gap is consistent with the blood pressure on the distal side of the second head, and under the action of the hemostasis valve on the proximal end of the gap, the blood in the gap passes through the gap.
  • the return channel flows into the distal side of the second head and returns into the blood vessel, reducing the amount of blood in the blood vessel of the human body that is carried out of the human body with the withdrawal of the pre-expander
  • the second head comprises a first segment in the shape of a conical ring, and the outer diameter of the middle of the first segment is larger than the outer diameter of both ends;
  • the backflow channel is provided at least in the middle of the first section; the proximal end of the first section is connected with the distal end of the pre-expanded tube.
  • the first section of the conical ring type makes it easier for the head end of the second head to penetrate into the expansion tube, and the end of the second head makes it easier for the second head to exit the expansion tube; and the return channel is set at the end of the first section. On the middle, easy to process.
  • Fig. 1 is the structural representation of the vascular sheath device provided by the application
  • FIG. 2 is an exploded schematic view of the hose, the expansion tube and the head cap of the first embodiment in FIG. 1;
  • FIG. 3 is an exploded schematic view of the distal end of the dilation tube and the head cap of the first embodiment in FIG. 2;
  • Fig. 4 is the longitudinal cross-sectional schematic diagram of the dilation tube of the vascular sheath device in Fig. 1;
  • Figure 5a is a schematic cross-sectional view of the outer casing and the hemostatic valve of the vascular sheath device in Figure 1;
  • Figure 5b is a schematic cross-sectional view of the outer casing of the vascular sheath device and the hemostatic valve in another direction in Figure 5a;
  • Fig. 5c is a partial enlarged schematic view of the section of the outer casing of the vascular sheath device and the hemostatic valve in Fig. 5a;
  • Fig. 6 is the exploded schematic diagram of the hemostatic valve of the vascular sheath device in Fig. 1;
  • Fig. 7 is the structural schematic diagram of the first sealing member in Fig. 6;
  • FIG. 8 is a schematic structural diagram of the second seal in FIG. 6;
  • Fig. 9a is the structural representation of the gasket in Fig. 6;
  • Figure 9b is a schematic structural diagram of another embodiment of the gasket in Figure 6;
  • Fig. 10 is the structural representation of the base in Fig. 6;
  • Figure 11 is an exploded schematic view of the distal end of the housing and the cage nut, an embodiment of the retaining ring;
  • Fig. 12 is the exploded schematic diagram of the first support ring and the second support ring in Fig. 6;
  • 13 is a schematic structural diagram of the pre-expander in the matching structure provided by the application.
  • Figure 14 is a schematic structural diagram of the second head of the pre-expander in Figure 13;
  • Figure 15a is an exploded schematic view of the flexible tube, dilation tube, imaging ring, and head cap of the second embodiment of the vascular sheath device in Figure 1;
  • Figure 15b is a schematic structural diagram of the head cap in Figure 15a;
  • Fig. 16a is another embodiment of the fixing ring of the vascular sheath device in Fig. 1;
  • Fig. 16b is a partial enlarged schematic view of the distal end of the fixing ring in Fig. 16a;
  • Figure 17a is a schematic structural diagram of an expansion tube
  • Figure 17b is a partial longitudinal cross-sectional schematic view of the expansion tube in Figure 17a;
  • FIG. 18 is a partial enlarged structural schematic diagram of the pre-expanded tube in FIG. 13 .
  • the present application provides an expansion tube, which includes at least one deformation portion 11 distributed along its circumferential direction, and the first end 111 of any deformation portion 11 along the circumferential direction of the expansion tube is bent and distributed in the S direction toward the second end 112 ,
  • the deformed portion 11 can be stretched along the radial direction of the expansion tube to be in an expanded state when subjected to the expansion force in the radial direction of the expansion tube.
  • the deformation part 11 is not subject to the radial expansion force of the expansion tube.
  • the deformation part 11 is in the initial state of bending in the S direction, and the diameter of the inner hole of the expansion tube is the smallest; when the surgical instrument is passed through the inner hole of the expansion tube, and the outer diameter of the surgical instrument is larger than the inner hole diameter of the expansion tube, the outer circumference of the surgical instrument is The wall exerts a radial expansion force on the inner wall of the deformation part 11, and under the expansion force, the first end 111 and the second end 112 of the deformation part 11 are continuously spread along the outer peripheral wall of the surgical instrument in a direction away from each other, so that the The inner hole of the expansion tube is stretched radially to increase the diameter of the inner hole of the expansion tube, so that it can adapt to different sizes of surgical instruments to pass through the inner hole of the expansion tube; at the same time, in the initial state, the outer diameter of the expansion tube is small, It can be embedded in blood vessels of different sizes to effectively dilate blood vessels of different sizes and improve the adaptability of the dilation tube.
  • the expansion tube further includes at least one mounting portion 12 .
  • the mounting portion 12 and the deforming portion 11 are distributed in three, the mounting portion 12 and the deforming portion 11 are alternately distributed along the circumferential direction of the expansion tube, and the first end 111 and the second end 112 of the deforming portion 11 are respectively It is connected to its adjacent mounting portion 12 to form an annular tube.
  • the two ends of the mounting portion 12 in the circumferential direction of the expansion tube are the third end 121 and the fourth end 122 respectively, the first end 111 of the deforming portion 11 is connected to the fourth end 122 of the previous mounting portion 12, and the The second end 112 is connected with the third end 121 of the latter mounting portion 12 to enclose an annular tube.
  • the deformation part 11 in the expansion tube plays the role of radial deformation, and the installation part 12 plays the role of installing and positioning the deformation part 11; The amount of deformation in the direction is more uniform.
  • the inner peripheral walls of all the deformed parts and the inner peripheral walls of the mounting part 12 are located on the same circumferential surface, and the inner peripheral walls are located on the same circumference, so that the head of the distal end of the surgical instrument can smoothly follow the circumferential surface.
  • the surgical instrument can abut on the entire inner circumferential surface along its circumferential direction, so as to apply a radial expansion force to the deformation portion 11, so that the deformation portion 11 is radially stretched; all
  • the outer peripheral wall of the deformation part 11 and the outer peripheral wall of the mounting part 12 are located on the same circumferential surface, and the outer peripheral wall is located on the same circumference, so that the expansion tube is inserted into the blood vessel. , to prevent scratches on the inner wall of blood vessels.
  • the number of deformation parts 11 and installation parts 12 is not limited. For example, there may be one deformation part 11 and one installation part 12 ; or one deformation part 11 and two installation parts 12 , or one deformation part 11 .
  • the number of the installation parts 12 can be any other, and the number of the deformation parts 11 can be the same as or different from the number of the installation parts 12, and the specific number of the installation parts can be determined according to the needs.
  • the deformation portions 11 and the mounting portions 12 may not be alternately distributed along the circumferential direction of the expansion tube.
  • the first end 111 of the partial deformation part 11 is adjacent to the mounting part 12
  • the second end 112 is adjacent to another deformation part 11 , among the two adjacent deformation parts 11
  • the first end of the former deformation part 11 111 is connected to the second end 112 of the latter deformation part 11
  • the deformation amount of the two adjacent deformation parts 11 is larger and easier to deform.
  • the deformation portion 11 includes an inner layer segment 11a, at least one intermediate segment 11b and an outer layer segment 11c that are sequentially stacked and distributed from the inside to the outside along the radial direction of the expansion tube; the inner layer segment 11a, at least one middle section 11b and the outer layer section 11c are sequentially connected by a curved arc section 11d, so as to be bent in an S direction.
  • the inner layer section 11a, the middle section 11b and the outer layer section 11c are stacked and distributed along the radial direction of the expansion tube, and the free end of the inner layer section 11a serves as the first end 111 described above.
  • the free end of the outer layer segment 11c serves as the second end 112 mentioned above.
  • the second end 112 stretches and spreads toward both ends along the circumferential direction of the expansion tube, so as to open the inner hole of the expansion tube and increase the diameter of the inner hole of the expansion tube for the surgical instruments to pass through.
  • the maximum deformation amount of the deformation part 11 is to stretch the inner layer section 11a and the outer layer section 11c apart, and no longer stack and distribute on both sides of the middle section 11b, so that the inner hole diameter of the expansion tube reaches the maximum value.
  • the number of the middle section 11b may also be two, three, four, etc., and two adjacent middle sections 11b are connected by bending the arc section 11d.
  • a plurality of middle sections The segments 11b are stacked and distributed, the inner layer segment 11a is stacked on the inner side of the innermost middle segment 11b, and the outer layer segment 11c is stacked on the outer side of the outermost middle segment 11b.
  • the diameter of the inner hole of the expansion tube can be set smaller, and the expansion tube does not protrude and occupy the expansion tube. Therefore, the inner hole of the expansion tube has a larger deformation range, and can adapt to the expansion of blood vessels of different diameters in a larger range and the passage of surgical instruments of different sizes in a larger range.
  • the above-mentioned inner layer segment 11a, a plurality of intermediate segments 11b and outer layer segments 11c can be stacked and distributed along the radial direction of the expansion tube, and can also be stacked and distributed along the circumferential direction of the expansion tube.
  • the entire deformation portion 11 is distributed along the expansion tube
  • the circumferential direction of the deformation part 11 is distributed in a wavy line in the S direction.
  • the above-mentioned deformation portion 11 can be made of polymer plastic.
  • the expansion tube is generally switched from the initial state to the expansion state. Also in use, it can also be retracted under the action of the blood vessel wall and used as a disposable expansion tube.
  • the deformation part 11 is preferably made of deformed material; the deformation part 11 can be switched between the expansion state and the initial state; in the initial state, the expansion force is cancelled, and the deformation part 11 is along the radial direction of the expansion tube. Contraction reset.
  • the expansion tube is reset to the initial state under the action of its own deformable material, that is, the first end 111 and the The second end 112 is retracted along the circumferential direction of the expansion tube, so that the inner layer section 11a, the middle section 11b and the outer layer section 11c are stacked and distributed in the S direction.
  • the deformable material is made of shape memory material.
  • the inner layer section 11a, the middle section 11b and the outer layer section 11c are kept in the S direction under the shape memory effect of the shape memory material. Distribution.
  • the shape memory material is a shape memory alloy material, and after the deformation portion 11 is formed, the above-mentioned S direction is maintained.
  • the deformable material can also be other existing elastic materials.
  • the present application provides a vascular sheath device, as shown in FIG. 1 to FIG. 14 , which includes a housing 26 , a hemostatic valve 2 and a dilation tube 1 .
  • the hemostatic valve 2 is sealed on the opening of the proximal end of the housing 26 ;
  • the outer wall of the distal opening of the housing 26 has external threads
  • the proximal opening of the dilation tube 1 is fixed with a fixing ring 28, and the distal end of the housing 26 is threadedly connected
  • the proximal end of the fixing ring 28 is a flared structure
  • the flared end of the flared structure is sleeved on the distal end of the housing 26 and is clamped between the locking member 27 and the distal end of the housing 26, In order to realize the connection between the expansion tube 1 and the distal end of the housing 26 .
  • the expansion tube 1 tends to maintain the initial state of radial contraction due to the radial restraint force of the hose 13, that is, the expansion tube 1 is in passive deformation and retraction.
  • the hose 13 is a polymer hose with shrinking and expanding functions, such as a silicone tube, a latex tube, a PU tube, and the like.
  • the flexible tube has good elasticity.
  • the flexible tube 13 is also stretched, which can wrap the expansion tube 1. Its smooth outer surface is in contact with the blood vessel wall.
  • the flexible tube 13 retracts automatically, exerts a radial binding force on the expansion tube 1, and causes the expansion tube 1 to shrink and reset in the radial direction.
  • part of the outer wall surface of the hose 13 and the mounting part 12 are bonded by glue, but not glued to the outer wall surface of the deformation part 11 , so that when the deformation part 11 is deformed, the hose 13 has a corresponding deformability to adapt to Deformation of the deformation portion 11 .
  • the hose 13 and the mounting part 12 are bonded with glue to ensure that the hose 13 will not be wrinkled due to friction and affect its function during use. Dotted line type), helical shape around the axis, annular shape not parallel to the axis, etc.
  • the outer peripheral wall of the flexible tube 13 is coated with a hydrophilic coating to reduce the friction between the outer wall of the flexible tube 13 and the blood vessel wall force, play a lubricating role, reduce the friction of the hose 13 against the blood vessel wall, and further play the role of protecting the blood vessel.
  • the vascular sheath device also includes a head cap 14 provided at the distal end of the dilation tube 1; a first embodiment of the head cap 14 is illustrated in Figures 2 and 3, and the head cap 14 is provided with at least one first Deformation seam 141, and at least one connecting portion provided at the proximal end and/or the distal end of the first deformation seam 141 to connect parts of the head cap 14 on both sides of the first deformation seam 141; the head cap 14 passes through the The first deformation seam 141 is radially stretched with the expansion of the deformation portion 11 , that is, there is a deformation amount in the radial direction for the surgical instrument to pass through.
  • All the first deformation slits 141 are distributed on the head cap 14 at intervals along the circumferential direction of the expansion tube 1 , for example, there are three first deformation slits 141 , and the three first deformation slits 141 are evenly distributed in the circumferential direction of the head cap 14 , the head cap 14 is divided into three parts in the circumferential direction, namely the first part, the second part and the third part, for example, the distal end (and/or the proximal end) of each first deformation seam 141 is provided There are connecting parts to connect two adjacent parts of the head cap.
  • the number of the first deformation seams 141 may also be other, such as one, two, four, five, six, etc., and the specific number is not limited.
  • the setting of the first deformation seam 141 is to ensure that the vascular sheath can maintain the shape of the head cap 14 before it is expanded, so as to be inserted into the blood vessel and move in the blood vessel, so that the dilatation tube 1 slides in place in the blood vessel to establish the required passage. , and when the surgical instrument is passed through, the first deformation seam 141 provides a deformation amount for the radial deformation of the head cap 14, so that the head cap 14 is easily torn apart without blocking the passage of the instrument.
  • a plurality of connecting parts may be provided to connect parts of the head cap 14 on both sides of the first deformation seam 141 .
  • the length of the first deformation seam 141 is not less than the length of the connecting portion, which ensures that the head cap 14 has a large deformation space when the surgical instrument is passed through, making it easier to be torn apart .
  • the first deformation seam 141 can be in the shape of a straight line, an L shape, an S shape, a Z shape, or a deformation seam of other shapes, which is not specifically limited and can be selected according to needs.
  • FIG. 1 There are many ways to connect the head cap 14 to the distal end of the expansion tube 1.
  • a clamping groove 151 extending axially along the expansion tube 1, and the other is provided with a latching protrusion 152 extending along the axial direction of the expansion pipe 1.
  • the connection between the mounting part 12 and the head cap 14 is realized.
  • the proximal end of the head cap 14 is provided with a snap groove 151
  • the distal end of the mounting portion 12 of the expansion tube 1 is provided with an engaging protrusion 152.
  • the positions of the snap groove 151 and the engaging protrusion 152 can be reversed.
  • the connection between the head cap 14 and the distal end of the mounting portion 12 of the expansion tube 1 is achieved through the engagement relationship between the engagement protrusion 152 and the engagement slot 151 .
  • the distal end of the head cap 14 and the mounting portion 12 can also be welded or bonded together with the card groove 151 and the engaging protrusion 152 in addition to the plug-in engagement of the card groove 151 and the engaging protrusion 152, or using Spot welding or welding, or other existing fixing methods can be used, or these fixing methods can be used simultaneously.
  • platinum-iridium alloy material is melted on the head cap 14, which has the effect of developing, which is convenient for capturing the position of the dilation tube 1 in the human body more easily in the blood vessel.
  • the distal end of the head cap 14 is rounded, which makes it easier to enter and exit the blood vessel with less damage to the blood vessel.
  • a first protrusion is formed between two adjacent card slots 151 , a stepped surface is formed between the first protrusion and the head cap 14 , and the distal end of the above-mentioned hose 13 is sleeved on the first protrusion up, and the distal end face of the hose 13 abuts on the step surface, and the hose 13 and the first protrusion are bonded and fixed by glue discontinuously, so that the first deformation seam 141 of the head cap 14 and the The hose 13 has a deformable amount when expanded.
  • connection point is not limited to all bonding, but also includes partial connection, that is, at 141 of the deformation seam
  • the parts of the head caps on both sides are bonded, and the deformation seam 141 exists to ensure that the hose 13 has a sufficient deformation amount during radial expansion.
  • the second embodiment of the head cap 14 shown in FIG. 15a and FIG. 15b is different from the head cap 14 shown in FIG. 3 in that the outer wall of the head cap 14 is provided with at least one accommodating groove. 142 is used to hold glue, so that the head cap 14 and the hose 13 can be bonded more precisely.
  • FIG. 15 a it also includes a developing ring 4 welded to the connection between the engaging protrusion 152 and the engaging groove 151 , and the developing ring 4 is provided with a second deformation corresponding to the first deformation seam 141 .
  • the slit 41 allows the developing ring 4 to have radial expansion deformation when the surgical instrument passes through the engaging protrusion 152 and the engaging groove 151 .
  • the developing ring 4 is placed over the engaging protrusions and the engaging grooves, and the engaging protrusions 152, the engaging grooves 151 and the developing ring 4 are welded together.
  • the developing ring 4 is fixed in the engaging protrusion and the engaging groove, or is fixed on the outer wall surface of the engaging protrusion and the engaging groove.
  • the expansion tube 1 includes a mounting section 16 and a main body section 17 integrally formed from the proximal end to the distal end; in the initial state without radial expansion force, the deformation of the proximal end of the mounting section 16
  • the part 11 is in an expanded state, the deformed part 11 of the main body section 17 is bent and distributed in the S direction, and the mounting section 16 is a tapered tube (in a trumpet-shaped structure) whose outer diameter is gradually reduced from its proximal end to the distal end, and is formed in a transitional manner.
  • the proximal end of the expansion tube 1 is connected to the distal end of the housing 26 through the installation section 16 ; the hose 13 is sheathed outside the proximal end of the expansion tube 1 .
  • the mounting section 16 forms the tapered tube described above.
  • the expansion degree of the deformation part 11 of the installation section 16 of the expansion tube 1 gradually decreases from the proximal end to the distal end, so that the proximal end of the installation section 16 is connected with other components, and the other components do not follow the radial expansion of the deformation part 11 .
  • Large or small and deformed at the same time, it is ensured that the deformed portion 11 of the main body segment 17 remains in a retracted state when it is not subjected to a radial expansion force, so that the outer diameter of the main body segment 17 is small, which is convenient for entering the blood vessel, that is, the installation segment 16 plays the role of.
  • the transition effect of connecting other components with the main body segment 17 will not affect the deformation process of the radial expansion or retraction of the main body segment 17 .
  • the vascular sheath device further includes a fixing mechanism provided on the proximal end of the dilation tube 1; 28 is sleeved outside the distal end of the housing 26, and the proximal end of the hose 13 is sleeved outside the fixing ring 28; , and clamp the fixing ring 28 and the proximal end of the hose 13 between the locking member 27 and the housing 26 to realize the connection between the proximal end of the mounting section 16 and the distal end of the housing 26 .
  • the locking member 27 is a nut, which is screwed on the distal end of the housing 26 to clamp and lock the proximal end of the mounting segment 16 , the proximal end of the fixing ring 28 and the proximal end of the hose 13 on the housing 26 . on the far end.
  • the locking member 27 may also be other structures, such as bolts or screws, or flanges and the like.
  • the proximal end of the fixing ring 28 protrudes out of the proximal end of the installation section 16, the proximal end of the hose 13 is sheathed outside the installation section 16 and the proximal end of the fixing ring 28, and glue can be used to seal the inner wall of the proximal end of the hose 13. It is adhered to the outer wall surfaces of the mounting segment 16 and the fixing ring 28 to enhance the tightness of the connection between the hose 13 , the fixing ring 28 and the mounting segment 16 .
  • the inner wall of the proximal end of the hose 13 may be completely bonded to the outer walls of the corresponding mounting section 16 and the fixing ring 28 , or may be partially bonded to the outer walls of the mounting section 16 and the fixing ring 28 .
  • the fitting method between the mounting section 16 and the fixing ring 28 may be an adhesive method or other fixing methods.
  • FIG. 11 shows the first embodiment of the fixing ring 28
  • FIG. 16a shows the second embodiment of the fixing ring 28
  • the fixing ring 28 in FIG. 11 is used as an example for description.
  • the mounting section 16 is formed by shaping the proximal end of the expansion tube 1 , and the fixing ring 28 is provided with a one-to-one corresponding fitting for the mounting portions 12 on the mounting section 16
  • the mounting grooves 282 are inserted into the mounting grooves 282 in a one-to-one correspondence through the mounting portions 12 on the mounting segment 16 , so as to realize the cooperation between the mounting segment 16 and the fixing ring 28 .
  • the proximal end of the fixing ring 28 is a flared portion 283 that expands toward the proximal end of the housing 26, and the flared portion 283 is clamped between the housing 26 and the locking member 27, so that the fixing ring 28 is easily clamped between the housing 26 and the locking member 27 .
  • the expansion tube 1 is made of polymer plastic, and then the fixing ring 28 and the installation section 16 are bonded and fixed with a polymer adhesive, so that the fixing ring 28 and the installation section 16 are perfectly fitted to ensure the tightness of the connection. .
  • the structure of the fixing ring 28 shown in FIG. 16a is different from that of the fixing ring 28 shown in FIG. 11 , the difference is: the distal end of the fixing ring 28 is a tapered portion 281 which is matched with the tapered tube; the tapered portion 281 is provided with The mounting grooves 282 that are suitable for the mounting portions 12 on the mounting segment 16 to be embedded in one-to-one correspondence; The contact area increases the support force for the expansion tube 1, so that the expansion tube 1 will not be deformed during use to affect the operation, and the connection between the fixing ring 28 and the expansion tube 1 is firmer. The support force of the expansion tube 1, the expansion tube 1 will not be bent due to the large resistance.
  • the distal end of the fixing ring 28 is provided with at least one third deformation slit 2811 extending along its axial direction, so as to ensure that the fixing ring 28 can deform in the radial direction and retract automatically to adapt to the deformed portion The process of radial enlargement or automatic retraction of 11.
  • the inner wall surface of the distal end of the fixing ring 28 is flared from the proximal end to the distal end. For example, by reducing the thickness of the distal end of the fixing ring 28 at different positions, to The flaring is formed so that after the instrument passes through the fixing ring 28 and enters the dilation tube 1 , when the device is withdrawn from the dilation tube 1 , the setting of the flaring does not jam the instrument.
  • the hemostatic valve 2 includes a first sealing member 21 , a second sealing member 22 , a plurality of sealing gaskets 23 and a base 25 .
  • the first sealing member 21 includes a first annular base 212, at least one sealing protrusion 213 formed on the distal end of the first annular base 212 and protruding toward the distal end of the first annular base 212, and the end surface of the sealing protrusion 213
  • a first sealing channel 211 is provided; the two side walls of the sealing protrusion 213 are sloped, and the slope is inclined from the distal end of the sealing protrusion 213 to the root of its proximal end, and the two side walls of the sealing protrusion 213 are affected by the distal end of the sealing protrusion 213.
  • the pressure of the medium at the place squeezes the sealing protrusion 213 to force the first sealing channel 211 to close.
  • the sealing protrusion 213 includes four branch protrusions, the branch protrusions form a cross protrusion, and the two side walls of each branch protrusion respectively form a slope, and the cross protrusions
  • the first sealing channel 211 on the starting end surface constitutes a cross slit.
  • each slope is inclined downward from the end surface of the corresponding branch boss toward its root.
  • the slope angle of the blood or solution along the slope is , exerting pressure on the slope surface, the pressure has a uniform component in the radial and axial directions of the first annular base 212, the radial component forces the slope surface to squeeze the branch bosses, and the slope surfaces on both sides of each branch boss face the slit Squeeze the corresponding branch bosses, so that the cross slit tends to be sealed or closed, and the blood is blocked at the distal side of the sealing protrusion 213 and will not flow out of the human body through the hemostatic valve 2 .
  • the cross slit also facilitates to ensure that subsequent instruments pass through the first sealing member 21 more easily.
  • the slope includes a first slope 2131 and a second slope 2132, the proximal end of the first slope 2131 is connected with the distal end of the second slope 2132, and the first slope
  • the distal end of an inclined surface 2131 is connected to the end surface of the sealing protrusion 213, the proximal end of the second inclined surface 2132 is formed on the first annular base 212, and the inclination angle of the first inclined surface 2131 relative to the end surface of the sealing protrusion 213 is the same as that of the sealing protrusion 213.
  • the inclination angles of the second inclined surface 2132 with respect to the end surface of the sealing protrusion are different.
  • the inclination angle of the first inclined surface 2131 is greater than the inclination angle of the second inclined surface 2132, so that the radial component of the blood pressure received at the first inclined surface 2131 is greater than the radial component of the blood pressure received at the second inclined surface 2132 in the radial direction.
  • the first inclined surface 2131 squeezes the branch boss more concentratedly, and further ensures the sealing performance of the sealing protrusion 213 .
  • the inclination angle of the first inclined surface 2131 is smaller than the inclination angle of the second inclined surface 2132 .
  • the cross slit can be replaced with a circular through hole, or a through hole of other shapes, as long as the axis of the first sealing channel 211 coincides with the axis of the expansion tube 1 .
  • the sealing protrusion 213 it can also be a straight-shaped protrusion, or a rice-shaped protrusion, or a protrusion of other shapes, as long as the two side walls of each branch boss of the sealing protrusion 213 are the above-mentioned slopes face.
  • the structure of the second sealing member 22 is similar to that of the first sealing member 21 .
  • the second sealing member 22 includes a second annular base body 222 .
  • the second protrusion 223 protrudes toward the distal end of the second annular base 222 , the second protrusion 223 is provided with a second sealing channel 221 , and the second sealing channel 221 is coaxially communicated with the first sealing channel 211 .
  • the second protrusion 223 is in the shape of a bowl or a ball, and a second sealing channel 221 is provided at the center of the second protrusion 223 .
  • the second sealing channel 221 is a cross slit or a zigzag slit, or a through hole.
  • the second seals 22 are stacked and distributed on the proximal side of the first seals 21 to further form a second seal to assist the first seals 21 in further sealing.
  • the second sealing member 22 further includes at least one first reinforcing rib 225.
  • first reinforcing rib 225 As shown in FIG. 8, four first reinforcing ribs 225 are provided, and the four first reinforcing ribs 225 are evenly distributed, and each first reinforcing rib 225 One end is fixed on the outer wall of the distal end of the second protrusion 223 , and the other end is fixed on the inner wall of the second annular base 222 to increase the strength of the second protrusion 223 .
  • the number of the first reinforcing ribs 225 can be other, for example, one, two, three, five, etc., and the specific number is selected according to needs.
  • the hemostatic valve 2 further includes a sealing gasket 23 laminated and sandwiched between the first sealing member 21 and the second sealing member 22, a third sealing channel 231 is provided on the sealing gasket 23,
  • the sealing channel 231 , the first sealing channel 211 and the second sealing channel 221 are distributed on the axis of the expansion tube 1 to form multiple seals between the first sealing member 21 and the second sealing member 22 .
  • Each gasket 23 forms one seal, for example, two gaskets 23 form two seals.
  • the outer peripheral edge of the above-mentioned sealing member is tightly abutted on the inner hole wall surface of the casing 26 to form a sealing connection with the inner hole wall of the casing.
  • the gasket 23 is a circular plate, and a third sealing channel 231 is provided at the center of the gasket 23.
  • the third sealing channel 231 can be a through hole and/or a slit to further strengthen the sealing effect.
  • the sealing gasket 23, the first sealing member 21 and the second sealing member 22 are all made of rubber material, the third sealing channel 231 of the sealing gasket 23 is a through hole, and the diameter of the through hole is smaller than the outer diameter of the guide wire, It can play a sealing role when the guide wire is passed, and the soft silicone material sealing gasket 23 has good elasticity, so that the diameter of the circular hole can be expanded to a larger range for the passage of large-diameter instruments.
  • the third sealing channel 231 includes a through hole and at least one cutting groove 234 distributed on the outer circumference of the through hole, and the inner cavity of the cutting groove 234 communicates with the through hole.
  • the third sealing channel 231 includes a cross-shaped cutting groove provided on the distal end surface of the sealing gasket 23 and an “X”-shaped cutting groove provided on the proximal end surface or provided at the distal end of the sealing gasket 23 .
  • the "X"-shaped cutting grooves on the end face and the cross-shaped cutting grooves on the proximal end face, the cross-shaped cutting grooves and the "X"-shaped cutting grooves together make the cutting grooves have a rice-shaped structure.
  • the cutting groove communicates with a channel located in the middle of the cutting groove of the rice-shaped structure.
  • the sealing gasket When the surgical instrument passes through the through hole of the third sealing channel 231, under the action of the radial spreading force of the surgical instrument, the sealing gasket can be easily deformed and stretched radially from the position of the cutting groove, so as to reduce the distance between the surgical instrument and the second seal.
  • the contact area of the component 22 is changed from the original surface-to-surface contact to the surface-to-line or point contact, which reduces the frictional force of the surgical instrument passing through the third seal for the surgical instrument to pass through.
  • the cutting groove 23 can also be a straight-line shape, or a cutting groove 234 of other shapes, which can be selected according to requirements, and is not limited to the above-mentioned rice-shaped shape, but also a cross-shaped shape.
  • the cutting groove 234 may also be provided only on the distal end face or the proximal end face of the sealing gasket 23 .
  • some cutting grooves 234 are distributed on the proximal end face of the gasket 23, and some cutting grooves 234 are distributed on the distal end face of the sealing gasket 23; preferably, a plurality of cutting grooves 234 on the same end face
  • the grooves 234 are evenly distributed around the outer circumference of the channel.
  • the third sealing channel 231 can also be a slit similar to the above-mentioned first sealing channel 211 or the second sealing channel 221 .
  • first sealing member 21 sealing gasket and second sealing member 22 are stacked and distributed from the distal end to the proximal end.
  • a radially protruding annular flange 251 is provided on the proximal end face of the base 25, and the base 25 is embedded in the proximal opening of the housing 26,
  • the annular flange 251 is tightly hooked on the proximal end surface of the housing 26, and a plurality of snap-fit projections 252 are radially protruded from the outer peripheral wall of the base 25; correspondingly, the housing 26 is provided with snap-fit projections 252 is inserted into the card hole 265, and the snap protrusion 252 is inserted in the card hole to realize the assembly of the base 25 and the shell 26, so that the entire hemostatic valve 2 can be assembled without adding any adhesive to the base 25 and the shell 26. Seal the connection.
  • a guide channel is provided on the base 25 , and the guide channel is coaxially distributed with the first sealing channel 211 , the second sealing channel 221 and the third sealing channel 231 .
  • the end face of the distal end of the base 25 abuts on the proximal end face of the second annular base body 222 of the second sealing member 22;
  • the distal end face of the first sealing member 21 abuts against the first annular step 261 , thereby realizing the installation and cooperation of the first sealing member 21 , the second sealing member 22 and the sealing gasket 23 on the housing 26 and the base 25 .
  • a conical guide head 253 is provided on the distal end surface of the base 25 , and the guide head extends into the inner hole of the second annular base body 222 of the second sealing member 22 , on the one hand, facing the base 25 . On the other hand, it plays a guiding role for the instruments to pass through the guiding channel of the base 25 and enter the second sealing channel 221 of the second sealing member 22 in sequence.
  • the hemostatic valve 2 further includes a first support ring 241 and a second support ring 242 , wherein the first support ring 241 is sandwiched between the two sealing gaskets 23 to support the sealing gasket 23 .
  • the gasket 23 includes a circular body, and a fitting body formed on the outer peripheral wall of the circular body.
  • the longitudinal cross-sectional shape of the fitting body is a trapezoid, and the short side of the trapezoid is formed on the outer peripheral wall of the circular body.
  • the long side of the ring is used as the outer peripheral wall of the gasket 23 and is matched with the inner hole wall of the housing 26; correspondingly, a third inclined surface 2411 is respectively provided on the proximal end and the distal end of the outer peripheral wall of the first support ring 241;
  • the trapezoidal hypotenuses 232 of the sealing gaskets 23 have the same inclination angle respectively with a third inclined surface 2411 and are in close contact with each other.
  • the outer peripheral wall of the gasket 23 further closely abuts on the inner hole wall of the casing 26 , thereby keeping the outer peripheral wall of the gasket 23 and the inner hole wall of the casing 26 in a sealed state.
  • the second support ring 242 is provided between the sealing gasket 23 and the second sealing member 22 to support the second sealing member 22 and the sealing gasket 23 .
  • a guide cylinder 224 is further provided on the distal end of the second annular base body 222 of the second seal 22, and the above-mentioned second protrusion 223 is located in the guide cylinder; the above-mentioned second support ring 242 is sleeved outside the guide cylinder, The proximal end of the second support ring 242 abuts on the distal end surface of the second annular base body 222 .
  • the function of the inclined surface 2421 and the fourth inclined surface 2421 is the same as that of the third inclined surface 2411. They both exert a pressing force on the trapezoidal hypotenuse of the sealing gasket 23, and further ensure that the outer peripheral wall of the sealing gasket 23 and the The inner bore wall of the housing 26 remains in sealing abutment.
  • the proximal end surface of the first sealing member 21 is provided with a fifth inclined surface which is matched with the trapezoidal hypotenuse 232 of the adjacent sealing gasket 23 .
  • the first support ring 241 and the second support ring 242 may not be provided with the above-mentioned inclined surfaces, and the sealing gasket 23 is not provided with a corresponding trapezoidal hypotenuse, the support ring only plays a supporting role, and the first sealing member , The outer peripheral wall of the second sealing member and the sealing gasket is tightly abutted on the inner hole wall of the casing to realize a sealed connection.
  • the above-mentioned second sealing member 22 or the sealing gasket 23 may not be provided, and the above-mentioned hemostatic effect can be achieved only by providing the above-mentioned base 25 and the first sealing member 21 .
  • the base may not be provided at all, and only the first sealing member may be provided, and the outer peripheral edge of the first sealing member can be directly sealed and clamped in the circumferential groove of the inner hole wall of the casing to realize the sealing installation of the first sealing member and the casing.
  • the hemostatic valve 2 can also adopt a one-way valve of other structures, and is not limited to the hemostatic valve 2 mentioned above.
  • a connecting channel 262 is provided on the side wall of the housing 26; as shown in FIG. 1, a three-way valve 263 is also included, and a first pipeline is passed between the three-way valve 263 and the connecting channel 262. 264 is connected, and the required liquid is delivered into the expansion tube 1 through the three-way valve 263.
  • the first pipeline 264 is a relatively soft pipe, such as a PU pipe or a silicone pipe.
  • the three-way valve 263 can be selected as a three-way stopcock, and its function is to empty the gas in the dilation tube 1 before the vascular sheath is used, and to discharge the air brought by the surgical instrument into the dilation tube 1 during use. .
  • the embodiment of the present application provides a vascular sheath device, which is different from the vascular sheath device provided in Embodiment 2 in that:
  • the expansion tube does not include the mounting portion 12, but only includes the deformation portion 11, and the number of the deformation portion 11 may be one, two, or more.
  • the first end 111 and the second end 112 of the deformation portion 11 form a closed loop.
  • the instrument is inserted into the expansion tube 1 and a radial expansion force is applied to the deformation portion 11, the It is stretched radially to change its bore diameter.
  • the first ends 111 of any two adjacent deformation parts 11 are connected with the other deformed second end 112 to form an annular tube, and the expansion tube 1 adopts the deformation parts 11 along its circumference. formed to further increase the radial deformation of the expansion tube.
  • the present application provides a matching structure of a vascular sheath device and a pre-expander, as shown in FIG. 1 and FIG. 13 , including: the vascular sheath device provided in Embodiment 2 or Embodiment 3 above; and a pre-expander.
  • the pre-expander includes a pre-expanded tube 31 , and a second head 32 disposed on the distal end of the pre-expanded tube 31 . At least part of the second head 32 has a larger outer diameter than the head of the expansion tube 1 .
  • the inner diameter of the distal end of the cap, the pre-expanded tube and the second head 32 are suitable for sliding in the expansion tube 1 to spread the head cap 14 of the expansion tube in the radial direction.
  • the pre-expander since the outer diameter of at least part of the second head 32 is larger than the inner diameter of the distal end of the head cap 14 of the dilation tube 1, after the dilation tube 1 slides in place in the blood vessel, the pre-expander is first used.
  • the pre-expanded tube and the second head 32 slide in the expansion tube 1, and at least part of the second head 32 passes through the distal end of the head cap 14 of the expansion tube 1, and the head cap 14 of the expansion tube 1 along the diameter
  • the pre-expander is retracted from the expansion tube 1, and the surgical instrument is passed through the head cap 14 of the expansion tube 1, the radial force of the surgical instrument by the head cap 14 is small, which is convenient for the surgical instrument to wear.
  • the head cap 14 can protect the head of the surgical instrument.
  • At least part of the second head 32 is provided with a return channel extending along its axial direction, and both the proximal end and the distal end of the return channel are open.
  • the second head 32 of the pre-expander pre-expands the head cap 14 of the dilation tube 1
  • the second head 32 is located in the blood vessel wall outside the distal end of the head cap 14;
  • the hemostatic valve 2 is provided on the proximal end of the dilation tube 1 because at least part of the second head 32
  • a return channel is set up so that the blood on both sides of the return channel is connected, that is, the blood pressure in the above-mentioned gap is consistent with the blood pressure on the distal side of the second head 32, and under the action of the hemostatic valve 2 on the proximal end of the gap to stop bleeding,
  • the blood in the gap flows into the distal side of the second head 32 through the return channel, and flows back into the blood vessel, reducing the amount of blood in the blood vessel of the human body that is carried out of the human body with the withdrawal of the pre-expander.
  • the return channel is a radially inwardly recessed return groove 321 provided on the above-mentioned at least part of the outer peripheral wall of the second head, and the return groove 321 may be one or one For two, the specific number of settings can be set according to actual needs.
  • the return groove 321 can be replaced with a through hole, and both ends of the through hole are open, which can also reduce the amount of blood in the blood vessels of the human body that is carried out of the human body.
  • the second head 32 includes a first section 322 in the shape of a conical ring and a second section 323 formed on the proximal end of the first section 322 , the middle of the first section 322 is outside the middle The diameter is larger than the outer diameter of both ends; the return channel is set at least in the middle of the first section 322; the proximal end of the second section 323 is sleeved outside the distal end of the pre-expanded tube 31; the outer diameter of the second section 323 is smaller than or equal to the outer diameter of the proximal end of the first segment 322 .
  • the arrangement of the second section 323 forms a transitional connection between the proximal end of the first section 322 and the distal end of the dilation tube 1, and the conical ring-shaped first section 322 makes it easy for the distal end of the second head 32 to penetrate into the dilation tube, The end of the second head 32 is easier to exit the expansion tube; and the return channel is provided on the middle of the first section 322 to facilitate processing.
  • the return groove can be provided only in the middle of the first section 322, or can be further extended to the proximal end and the distal end of the first section 322.
  • the first section can be ensured.
  • the blood on both sides of the proximal end and the distal end of the first segment 322 is communicated, so that the blood on the proximal side of the first segment 322 flows back into the blood vessel on the distal side of the first segment 322 .
  • the second head 32 may be provided with only the first segment 322 without the second segment 323, or the first segment 322 may be a cylindrical ring, and the outer diameter of the second head 32 at different positions along its axial direction is equal to Consistently, the aforementioned return passages extend through the proximal and distal ends of the second head 32 .
  • the outer diameter of the second head 32 is larger than the outer diameter of the pre-expanded tube.
  • the second head 32 mainly exerts a radial opening force on the head cap 14, and the pre-expanded tube is in the expansion tube. 1 to support the second head 32 , and it is convenient for the doctor to operate the handle on the proximal end of the pre-expanded tube to drive the second head 32 to slide in the expansion tube 1 and the head cap 14 .
  • the outer diameter of the pre-expanded tube is smaller than the inner diameter of the expansion tube 1
  • the outer diameter of the second head 32 is larger than the inner diameter of the expansion tube 1 and the head cap 14
  • the outer diameters of the pre-expanded tube and the second head 32 are smaller than the inner diameter of the expansion tube 1 when it is not stretched, so as to reduce the frictional force it receives when sliding in the expansion tube 1, but the outer diameter of the second head 32 larger than the inner diameter of the head cap 14 .
  • the pre-expanded tube 31 is provided with a plurality of cavities extending along its axial direction, and the metal wires 311 provided in the cavities are inserted into the pre-expanded tube 31 .
  • a plurality of metal wires surround the outer periphery of the inner hole of the pre-expanded tube 31, the inner hole is for the pulling wire to pass through, so as to pull the pre-expander into the blood vessel, and after the pre-expansion, the pre-expander is pulled withdraw from the vessel.
  • the pre-expander includes a pre-expanded tube 31 , and a second head 32 disposed on the distal end of the pre-expanded tube 31 , at least part of the second head 32
  • the outer diameter is larger than the inner diameter of the distal end of the head cap of the expansion tube 1 , and the pre-expanded tube and the second head 32 are suitable for sliding in the expansion tube 1 to spread the head cap 14 of the expansion tube in the radial direction.
  • the pre-expander since the outer diameter of at least part of the second head 32 is larger than the inner diameter of the distal end of the head cap 14 of the dilation tube 1, after the dilation tube 1 slides in place in the blood vessel, the pre-expander is first used.
  • the pre-expanded tube and the second head 32 slide in the expansion tube 1, and at least part of the second head 32 passes through the distal end of the head cap 14 of the expansion tube 1, and the head cap 14 of the expansion tube 1 along the diameter
  • the pre-expander is retracted from the expansion tube 1, and the surgical instrument is passed through the head cap 14 of the expansion tube 1, the radial force of the surgical instrument by the head cap 14 is small, which is convenient for the surgical instrument to wear.
  • the head cap 14 can protect the head of the surgical instrument.
  • pre-expander in this embodiment is the same as the pre-expander used in the matching structure of the vascular sheath device and the pre-expander in Embodiment 4, and are not repeated here.

Abstract

一种扩张管（1）、血管鞘装置、血管鞘装置与预扩器（3）的配合结构、预扩器（3）。扩张管(1)包括沿其周向分布的至少一个变形部(11)，变形部(11)上沿扩张管（1）周向的第一端(111)朝向其的第二端(112)呈S走向弯折分布，以围成环形；变形部(11)可在受扩张管（1）径向的扩张力时，沿扩张管（1）径向撑开而处于扩张状态。血管鞘装置包括外壳(26)、密封地设在外壳(26)的近端的开口上止血阀(1)、及安装在外壳(26)的远端开口上的扩张管(1)。血管鞘装置与预扩张器（3）的配合结构包括血管鞘装置，其中扩张管(1)的远端上设有头部帽(14)；以及预扩器(3)，其包括预扩管(31)，及设在预扩管(31)的远端上的第二头部(32)，第二头部(32)上的至少部分的外径大于扩张管(1)的头部帽(14)的远端的内径，预扩管(31)及第二头部(32)适于在扩张管(1)内滑动，沿径向以撑开扩张管（1）的头部帽(14)。

Description

扩张管、血管鞘装置、血管鞘装置与预扩器的配合结构、预扩器 技术领域
本申请属于医疗器械的技术领域，具体涉及一种扩张管、血管鞘装置、血管鞘装置与预扩器的配合结构、预扩器。
背景技术
作为动静脉介入手术的辅助导引器械，血管鞘在介入治疗中发挥着重要作用。血管鞘通过血管穿刺技术，使用穿刺导丝引导血管鞘装置扩张皮肤肌肉组织而进入表皮血管内腔中，然后取出穿刺导丝，使得血管鞘装置的远端置于血管内，这样就建立了一个由体外到血管内腔的通道，以供手术器械穿过。例如，人工心脏瓣膜置换手术一般采用介入瓣膜，介入瓣膜在通过股动脉、股静脉进入人体时需要血管鞘装置来建立通道。
例如，现有的血管鞘装置包括基座、止血阀、扩张管及鞘管；基座的近端开口上密封设有止血阀，基座的远端开口上设有鞘管，扩张管穿设在基座的内孔、鞘管的内孔中，且扩张管的近端呈扩口并位于基座的近端外，扩张管的远端伸出鞘管外。采用上述的血管鞘装置，对血管进行扩张时，硬质导丝依次穿在止血阀和扩张管的内孔中，硬质导丝的远端伸出扩张管的远端，以引导整个血管鞘装置在血管内移动，待移动到位后；扩张管伸出鞘管外，在血管内移动，对血管施加径向扩张力，以撑大血管的内径，之后手术器械经扩张管的内孔进入人体内，对病变位置进行手术。
但上述的血管鞘装置，扩张管的直径相对固定，只能单一地对一种疾病所对应的血管进行扩张。例如，经血管鞘瓣膜置换术的器械直径一般为6mm-10mm之间，而人体股动脉、股静脉的直径一般为4.5mm-7.2mm左右。而现有的血管鞘装置的扩张管的直径要不偏小，不能供瓣膜器械穿过；或者尺寸过大，例如，大血管内用的扩张管的直径一般在7mm-11mm之间，其进入股动脉、股静脉时，对血管壁产生一个破坏性的轴向摩擦力，会造成血管撕裂、钙化斑块脱落等血管并发症。
因此，现有的血管鞘装置一般是根据治疗不同类型的病所穿过的器官尺寸和供穿过的手术器械的尺寸进行定制，其扩张管的直径相对固定，不能适应性地对不同直径的血管进行有效扩张，及供不同尺寸的手术器械穿过，存在整体适应性差的缺陷。
此外，血管鞘装置的扩张管一般包括本体和固定在本体的远端上的头部帽，为避免扩张管在血管内滑行对血管壁有损伤，扩张管的头部帽一般呈光滑的圆锥面，头部的外径和内径均由其近端朝向远端逐渐减少。扩张管在血管内滑行到位后，当手术器械在扩张管内滑行，对扩张管施加径向扩张力，扩张管在该扩张力作用下径向变形被撑开，以供手术器械穿过。但是，当手术器械穿入头部帽内时，头部帽的外径和内径均由其近端朝向远端逐渐减少，尤其是头部帽的远端对手术器械的阻力更大，容易造成手术器械不能顺利通过头部帽的远端，即使通过头部帽的远端后，容易对手术器械的头部造成损伤，影响手术器械的后续在手术过程中的使用。
发明内容
本申请的一个目的在于克服现有的血管鞘装置的扩张管的直径相对固定，不能对不同直径的血管进行有效扩张，及供不同尺寸的手术器械穿过，整体适应性差的缺陷。
本申请的另一个目的在于克服现有技术中的以下缺陷，手术器械穿过扩张管的头部帽时，受到的阻力大，不便于手术器械顺利穿过，且易对手术器械的头部造成损伤，影响手术器械的正常使用。
为此，本申请提供一种扩张管，包括沿其周向分布的至少一个变形部，任一所述变形部上沿扩张管周向的第一端朝向第二端呈S走向弯折分布，以围成环形；所述变形部可在受扩张管径向的扩张力时，沿扩张管径向撑开而处于扩张状态。
可选地，上述的扩张管，还包括至少一个安装部，所述变形部的第一端和第二端分别与其相邻的变形部或安装部连接，以使所有所述变形部和安装部围成环形。
可选地，上述的扩张管，所述变形部和所述安装部沿扩张管的周向交替分布。
可选地，上述的扩张管，在初始状态，所有所述变形的内周壁和所述安装部的内周壁位于同一圆周面上，所有所述变形部的外周壁和所述安装部的外周壁位于同一圆周面上。
可选地，上述的扩张管，所述变形部为至少两个，沿扩张管周向，相邻两个变形部中，前一个变形部的第一端与后一个变形部的第二端连接。
可选地，上述的扩张管，所述变形部沿扩张管径向包括从内向外依次层叠分布的内层段、至少一个中间段及外层段；所述内层段、至少一个中间段及外层段依次通过弯折的圆弧段连接，以呈S 走向弯折。
可选地，上述的扩张管，所述变形部沿扩张管周向包括层叠分布的内层段、至少一个中间段及外层段；所述内层段、至少一个中间段及外层段依次通过弯折的圆弧段连接，使所述变形部沿扩张管的周向呈S走向的波浪线分布。
可选地，上述的扩张管，所述变形部采用变形材料制成；所述变形部可在扩张状态与初始状态之间切换；在初始状态，所述扩张力撤销，所述变形部沿扩张管径向收缩复位。
本申请还提供一种血管鞘装置，包括：外壳；止血阀，密封地设在所述外壳的近端的开口上；扩张管，安装在所述外壳的远端开口上，所述扩张管为上述的扩张管。
可选地，上述的血管鞘装置，还包括套在所述扩张管外的可变形的软管，所述扩张管受所述软管的径向束缚力而趋于保持径向收缩的初始状态。
可选地，上述的血管鞘装置，至少部分所述扩张管的安装部与所述软管通过胶水粘接。
可选地，上述的血管鞘装置，还包括设在所述扩张管的远端上的头部帽；所述头部帽上设有至少一个第一变形缝，以及设在所述第一变形缝的近端和/或远端的至少一个连接部，以将所述第一变形缝两侧的所述头部帽的部分连接；所述头部帽通过所述第一变形缝随所述变形部的扩张而径向撑开。
可选地，上述的血管鞘装置，所述连接部为至少两个，所述第一变形缝的长度不小于所述连接部的长度。
可选地，上述的血管鞘装置，所述头部帽的近端和所述扩张管的安装部的远端中的一个上，设有沿扩张管轴向延伸的卡槽，另一个上设有沿扩张管轴向延伸的卡合凸起，卡合凸起一一对应地卡接在卡槽内，而使所述头部帽与所述安装部连接。
可选地，上述的血管鞘装置，所述头部帽上熔有铂铱合金材料；或者，还包括熔接于所述卡合凸起和卡槽的连接处的显影环，所述显影环上设有对应于所述第一变形缝的第二变形缝。
可选地，上述的血管鞘装置，所述头部帽的外壁面上设有至少一个容纳槽，用于供胶水容纳，以至少使所述头部帽在容纳槽处与所述软管的内壁胶粘连接；或者，所述头部帽上相邻两个卡槽之间形成第一凸起，第一凸起与头部帽之间形成台阶面，所述软管的远端套在该第一凸起上，且软管的远端端面抵接在台阶面上，软管与第一凸起之间采用胶水不连续粘接固定。
可选地，上述的血管鞘装置，所述软管的外周壁上涂有亲水涂层。
可选地，上述的血管鞘装置，扩张管包括由近端朝向远端一体成型的安装段和主体段；在未受径向扩张力的初始状态，所述安装段的近端的变形部呈扩张状态，主体段的变形部呈S走向弯折分布，所述安装段由其近端朝向远端呈外径逐渐缩小的锥形管，以过渡成型在所述主体段的近端上；还包括设在所述扩张管的近端上的固定机构；所述固定机构包括与所述安装段插接的固定环，所述固定环套接在所述外壳的远端外，所述软管的近端套在所述固定环外；及锁紧部件，配合在所述外壳的远端外，且将所述固定环和软管的近端夹持在所述锁紧部件与所述外壳之间。
可选地，上述的血管鞘装置，所述固定环的远端呈与所述锥形管配合的锥形部，所述锥形部上设有适于供所述安装段上的安装部一一对应嵌入的安装槽。
可选地，上述的血管鞘装置，所述固定环的近端呈朝向外壳的扩口部，所述扩口部被夹持在所述外壳与锁紧部件之间。
可选地，上述的血管鞘装置，所述锁紧部件螺纹配合在所述外壳的远端上；和/或至少部分所述软管与所述安装段、固定环胶粘连接。
可选地，上述的血管鞘装置，所述固定环的远端上设有至少一个沿其轴向延伸的第三变形缝。
可选地，上述的血管鞘装置，所述固定环的远端的内壁面呈由其近端朝向远端的扩口。
可选地，上述的血管鞘装置，所述止血阀包括至少一个第一密封件；所述第一密封件包括第一环形基体，成型在所述第一环形基体的远端上且朝向环形基体的远端凸出的至少一个密封凸起，所述密封凸起的端面上设有第一密封通道；所述密封凸起的两侧壁呈坡面，所述坡面由所述密封凸起的远端朝向其近端的根部倾斜，所述密封凸起的两侧壁受其远端处的介质压力而挤压所述密封凸起，以迫使所述第一密封通道趋于关闭。
可选地，上述的血管鞘装置，所述坡面包括第一倾斜面和第二倾斜面，所述第一倾斜面的近端与所述第二倾斜面的远端连接，所述第一倾斜面的远端连接于所述密封凸起的端面，所述第二倾斜面的近端成型在所述第一环形基体上，所述第一倾斜面相对于所述密封凸起的端面的倾斜角度与所述第二倾斜面相对于所述密封凸起的端面的倾斜角度不同。
可选地，上述的血管鞘装置，所述第一密封通道为一字型缝或十字型缝或米字型缝。
可选地，上述的血管鞘装置，所述密封凸起包括四个分支凸台，所述分支凸台构成十字凸起，每个分支凸台的两侧壁分别呈一个坡面，所述十字凸起端面上的第一密封通道构成十字狭缝。
可选地，上述的血管鞘装置，所述止血阀还包括与所述第一密封件层叠分布的第二密封件；所述第二密封件包括第二环形基体，成型在所述第二环形基体的内孔中的第二凸起，所述第二凸起朝向所述第二环形基体的远端凸出，所述第二凸起上设有第二密封通道，所述第二密封通道与所述第一密封通道连通。
可选地，上述的血管鞘装置，所述第二密封件还包括至少一个第一加强筋，所述第一加强筋的一端固定在所述第二凸起的远端的外壁面上，另一端固定在所述第二环形基体的内壁面上。
可选地，上述的血管鞘装置，所述止血阀还包括层叠且夹设在所述第一密封件和第二密封件之间的至少一个密封垫，所述密封垫上设置第三密封通道，所述第三密封通道与所述第一密封通道、第二密封通道分布在所述扩张管的轴线上。
可选地，上述的血管鞘装置，所述第三密封通道包括通孔和/或至少一个切割槽，当所述第三密封通道包括通孔和至少一个切割槽时，所述至少一个切割槽分布在所述通孔的外周且与所述通孔连通；和/或所述密封垫的远端端面和/或近端端面上设有至少一个第二加强筋。
可选地，上述的血管鞘装置，所述第三密封通道的切割槽为至少两个，其中至少一个切割槽分布在密封垫的远端端面上，至少一个切割槽分布在所述密封垫的近端端面上；或者，所述第三密封通道包括设于所述密封垫远端端面的十字型切割槽和近端端面的“X”型切割槽或设于所述密封垫远端端面的“X”型切割槽和近端端面的十字型切割槽，所述十字型切割槽和“X”型切割槽一起，使切割槽呈米字结构，还包括与所述米字结构的切割槽连通且位于所述米字结构的切割槽中部的通道；或者，所述第三密封通道与所述第二密封通道相同。
可选地，上述的血管鞘装置，所述止血阀包括：至少两个密封垫；以及设在相邻两个密封垫之间的第一支撑环和/或设在所述密封垫与所述第二密封件之间的第二支撑环。
可选地，上述的血管鞘装置，所述第一支撑环的外周壁的近端和远端上分别设有一个第三倾斜面；两个密封垫外周处的斜边分别与一个第三倾斜面的倾斜角度相同并紧密地抵接；和/或，第二密封件的第二环形基体的远端上还设导向筒，所述第二凸起位于导向筒内；所述第二支撑环套在导向筒外，第二支撑环的近端抵接在第二环形基体的远端端面上，所述第二支撑环的远端端面上设有与密封垫外周处的斜边抵接配合的第四倾斜面；和/或，所述第一密封件的近端端面上设有与其相邻的密封垫外周处的斜边配合的第五倾斜面。
可选地，上述的血管鞘装置，所述止血阀还包括底座；所述外壳的内孔中设第一环形台阶；所述底座具有环形凸缘，所述底座紧密地嵌装在所述外壳的近端开口处，所述环形凸缘勾在所述外壳的近端端面上；至少所述第一密封件被紧密地夹持在所述底座的远端端面和第一环形台阶之间。
可选地，上述的血管鞘装置，所述底座的外周壁上设有径向凸出的至少一个卡接凸起，所述外壳上设有供所述卡接凸起一一对应插接的卡孔，所述底座和所述外壳之间通过所述卡接凸起插接在所述卡孔内而连接。
可选地，上述的血管鞘装置，所述外壳的侧壁上设有连接通道；还包括三通阀门，所述三通阀门与所述连接通道之间通过第一管路连接。
本申请还提供一种血管鞘装置与预扩器的配合结构，包括：上述的血管鞘装置，其中扩张管的远端上设有头部帽；预扩器，包括预扩管，及设在所述预扩管的远端上的第二头部，所述第二头部上的至少部分的外径大于扩张管的头部帽的远端的内径，所述预扩管及所述第二头部适于在所述扩张管内滑动，沿径向以撑开所述扩张管的头部帽。
可选地，上述的配合结构，所述第二头部的外径大于所述扩张管的头部帽的内径。
可选地，上述的配合结构，所述预扩管的外径小于所述第二头部的外径，且小于扩张管处于径向未撑开时的内径。
可选地，上述的配合结构，所述第二头部上的所述至少部分上设有沿其轴向延伸的回流通道，所述回流通道的近端和远端均呈开口。
可选地，上述的配合结构，所述回流通道为设在所述至少部分的外周壁上的径向向内凹陷的回流槽。
可选地，上述的配合结构，所述第二头部包括呈圆锥环型的第一段，所述第一段的中部外径大于其两端的外径；所述回流通道至少设在所述第一段的中部上；所述第一段的近端与所述预扩管的远端连接。
可选地，上述的配合结构，所述第二头部还包括成型在所述第一段的近端上的第二段，所述第一段的近端通过所述第二段的近端套接在所述预扩管的远端外；所述第二段的外径小于或等于所述第一段的近端的外径。
本申请还提供一种预扩器，包括预扩管，及设在所述预扩管的远端上的第二头部，所述第二头部上的至少部分的外径大于扩张管的头部帽的远端的内径，所述预扩管及所述第二头部适于在所述扩张管内滑动，沿径向以撑开所述扩张管的头部帽。
可选地，上述的预扩器，所述第二头部的外径大于所述扩张管的头部帽的内径。
可选地，上述的预扩器，所述预扩管的外径小于所述第二头部的外径，且小于扩张管处于径向未撑开时的内径。
可选地，上述的预扩器，所述第二头部上的所述至少部分上设有沿其轴向延伸的回流通道，所述回流通道的近端和远端均呈开口。
可选地，上述的预扩器，所述回流通道为设在所述至少部分的外周壁上的径向向内凹陷的回流槽。
可选地，上述的预扩器，所述第二头部包括呈圆锥环型的第一段，所述第一段的中部外径大于其两端的外径；所述回流通道至少设在所述第一段的中部上；所述第一段的近端与所述预扩管的远端连接。
可选地，上述的预扩器，所述第二头部还包括成型在所述第一段的近端上的第二段，所述第一段的近端通过所述第二段的近端套接在所述预扩管的远端外；所述第二段的外径小于或等于所述第一段的近端的外径。
本申请技术方案，具有如下优点：
1.本申请提供的扩张管，包括沿其周向分布的至少一个变形部，任一所述变形部上沿扩张管周向的第一端朝向其的第二端呈S走向弯折分布，以围成环形；所述变形部可在受扩张管径向的扩张力时，沿扩张管径向撑开而处于扩张状态。此结构的扩张管，由于变形部上沿扩张管周向的第一端朝向第二端呈S走向弯折分布，使变形部在不受扩张管径向扩张力时，变形部处于S走向弯折的初始状态；当手术器械穿在扩张管的内孔中，手术器械的外径大于扩张管的内孔直径时，手术器械的外周壁对变形部的内壁施加径向的扩张力，受该扩张力，变形部的第一端和第二端沿着手术器械的外周壁不断地朝向相互远离的方向铺展开，使扩张管的内孔沿径向撑开，增大扩张管的内孔直径，进而可以适应不同尺寸的手术器械穿过扩张管的内孔；同时，扩张管在初始状态下，其外径小，可嵌入不同尺寸的血管内，以对不同尺寸的血管进行有效扩张，提高扩张管使用的适应性。
2.本申请提供的扩张管，变形部采用变形材料制成；所述变形部可在扩张状态与初始状态之间切换；在初始状态，所述扩张力撤销，所述变形部沿扩张管径向收缩复位，当器械穿过扩张管后或退出扩张管后，扩张管在自身材料的复位作用下，变形部的第一端和第二端朝向相互靠近方向收缩，以复位到初始状态，在手术器械被包裹的部分内径会随着器械的移动而增大，未包裹的部分内径回复到原来的尺寸，使扩张管的内孔直径在撑开与缩小之间切换，实现扩张管适用不同的器械以及直径不同的血管，减少血管并发症，并可重复利用。
3.本申请提供的扩张管，在初始状态，所有变形部的外周壁与安装部的外周壁位于同一圆周上；确保扩张管能够插入血管内在血管内移动不会划伤血管壁。
4.本申请提供的血管鞘装置，包括上述的扩张管，从而使该血管鞘能够对不同直径的血管进行有效扩张，及供不同尺寸的手术器械穿过，提高血管鞘装置的适应性，不仅可以在瓣膜置换手术中，对股动脉、股静脉进行有效扩张，供手术器械穿过；还可以对其他尺寸的血管进行有效扩张，供对应的手术器械穿过。
5.本申请提供的血管鞘装置，还包括套在所述扩张管外的可变形的软管，所述扩张管受所述软管的径向束缚力而趋于保持径向收缩的初始状态。当手术器械退出扩张管后，在软管的径向束缚力作用下，扩张管的变形部在径向收缩复位；同时，软管的设置，使软管的光滑外壁面与血管壁接触，不会对血管壁造成损伤。进一步地，在软管的外周壁上涂有亲水涂层，对软管的外周壁起到润滑作用，以形成光滑表面，与血管壁接触。
6.本申请提供的血管鞘装置与预扩器的配合结构，包括上述的血管鞘装置，其中扩张管的远端上设有头部帽；以及预扩器，包括预扩管及设在所述预扩管的远端上的第二头部，所述第二头部上的至少部分的外径大于扩张管的头部帽的远端的内径，所述预扩管及所述第二头部适于在所述扩张管内滑动，沿径向以撑开扩张管的头部帽。此结构的预扩器，由于第二头部的至少部分的外径大于扩张管的头部帽的远端的内径，当扩张管在血管内滑动到位后，先用预扩器的预扩管和第二头部在扩张管内滑动，第二头部的至少部分穿过扩张管的头部帽的远端，将扩张管的头部帽沿径向撑开，之后将预扩器从扩张管内退出，再将手术器械穿过扩张管的头部帽时，手术器械受到头部帽的径向作用力小，便于手术器械穿过头部帽，对手术器械的头部起到保护作用。
7.本申请提供的血管鞘装置与预扩器的配合结构，所述第二头部上的所述至少部分上设有沿其轴向延伸的回流通道，所述回流通道的近端和远端均呈开口。此结构的预扩器，当预扩器的第二头部对扩张管的头部帽进行预扩之后，第二头部位于头部帽的远端外的血管壁内；即使血管内的部分血液流到第二头部的近端一侧的扩张管与预扩管之间的缝隙内时，并且扩张管的近端上设有止血阀，由于第二头部的至少部分处设置回流通道，使回流通道两侧的血液连通，即上述缝隙的血液压力与第二头部的远端一侧的血液压力一致，并在止血阀对缝隙的近端止血的作用下，缝隙内的血液经回流通道流入第二头部的远端一侧，回流到血管内，降低人体血管内部分血液随着预扩器退出而带出人体外的量。
8.本申请提供的血管鞘装置与预扩器的配合结构，所述回流通道为设在所述至少部分的外周壁上的径向向内凹陷的回流槽，便于回流通道的加工。
9.本申请提供的血管鞘装置与预扩器的配合结构，所述第二头部包括呈圆锥环型的第一段，所述第一段的中部外径大于其两端的外径；所述回流通道至少设在所述第一段的中部上；所述第一段的近端与所述预扩管的远端连接。圆锥环型的第一段，使第二头部的头端更易穿入扩张管内，第二头部的末端，使第二头部更容易退出扩张管；并且将回流通道设在第一段的中部上，便于加工。
本申请附加的方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本申请的实践了解到。
附图说明
为了更清楚地说明本申请具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本申请提供的血管鞘装置的结构示意图；
图2为图1中的软管、扩张管及第一种实施方式的头部帽的爆炸示意图；
图3为图2中扩张管的远端与第一种实施方式的头部帽的爆炸示意图；
图4为图1中血管鞘装置的扩张管的纵向截面示意图；
图5a为图1中血管鞘装置的外壳与止血阀处的剖面示意图；
图5b为图5a中血管鞘装置的外壳与止血阀另一个方向的剖面示意图；
图5c为图5a中血管鞘装置的外壳与止血阀的剖面的局部放大示意图；
图6为图1中血管鞘装置的止血阀的爆炸示意图；
图7为图6中第一密封件的结构示意图；
图8为图6中第二密封件的结构示意图；
图9a为图6中密封垫的结构示意图；
图9b为图6中密封垫的另一种实施方式的结构示意图；
图10为图6中底座的结构示意图；
图11为外壳的远端与锁紧螺帽、一种实施方式的固定环的爆炸示意图；
图12为图6中第一支撑环、第二支撑环的爆炸示意图；
图13为本申请提供的配合结构中的预扩张器的结构示意图；
图14为图13中预扩张器的第二头部的结构示意图；
图15a为图1中血管鞘装置的软管、扩张管、显影环、第二种实施方式的头部帽的爆炸示意图；
图15b为图15a中头部帽的结构示意图；
图16a为图1中血管鞘装置的固定环的另一种实施方式；
图16b为图16a中固定环的远端的局部放大示意图图；
图17a为扩张管的结构示意图；
图17b为图17a中扩张管的局部纵向剖面示意图；
图18为图13中预扩管的局部放大结构示意图。
附图标记说明：
1-扩张管；11-变形部；111-第一端；112-第二端；11a-内层段；11b-中间段；11c-外层段；11d-圆弧段；12-安装部；121-第三端；122-第四端；13-软管；14-头部帽；141-第一变形缝；142-容纳槽；151-卡槽；152-卡合凸起；16-安装段；161-延伸部；17-主体段；
2-止血阀；21-第一密封件；211-第一密封通道；212-第一环形基体；213-密封凸起；2131-第一倾斜面；2132-第二倾斜面；22-第二密封件；221-第二密封通道；222-第二环形基体；223-第二凸起；224-导向筒；225-第一加强筋；23-密封垫；231-第三密封通道；232-斜边；233-第二加强筋；234-切割槽；241-第一支撑环；2411-第三倾斜面；242-第二支撑环；2421-第四倾斜面；25-底座；251-环形凸缘；252-卡接凸起；253-导向头；26-外壳；261-第一环形台阶；262-连接通道；263-三通阀门；264-第一管路；265-卡孔；27-锁紧部件；28-固定环；282-安装槽；283-扩口部；281-锥形部；2811-第三变形缝；
3-预扩器；31-预扩管；32-第二头部；321-回流槽；322-第一段；323-第二段；
4-显影环；41-第二变形缝。
具体实施方式
下面将结合附图对本申请的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
此外，下面所描述的本申请不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
实施例1
本申请提供一种扩张管，其包括沿其周向分布的至少一个变形部11，任一变形部11上沿扩张管 周向的第一端111朝向第二端112呈S走向弯折分布，以围成环形；变形部11可在受扩张管径向的扩张力时，沿扩张管径向撑开而处于扩张状态。
此结构的扩张管，由于变形部11上沿扩张管周向的第一端111朝向其的第二端112呈S走向弯折分布，使变形部11在不受扩张管径向扩张力时，变形部11处于S走向弯折的初始状态，扩张管的内孔直径最小；当手术器械穿在扩张管的内孔中，手术器械的外径大于扩张管的内孔直径时，手术器械的外周壁对变形部11的内壁施加径向的扩张力，受该扩张力，变形部11的第一端111和第二端112沿着手术器械的外周壁不断地朝向相互远离的方向铺展开，使扩张管的内孔沿径向撑开，增大扩张管的内孔直径，进而可以适应不同尺寸的手术器械穿过扩张管的内孔；同时，扩张管在初始状态下，其外径小，可嵌入不同尺寸的血管内，以对不同尺寸的血管进行有效扩张，提高扩张管使用的适应性。
具体地，如图3和图4所示，扩张管还包括至少一个安装部12。比如，如图4所示，安装部12和变形部11分布为三个，安装部12和变形部11沿扩张管的周向交替分布，变形部11的第一端111和第二端112分别与其相邻的安装部12连接，以形成环形管。
例如，安装部12沿扩张管周向的两端分别为第三端121和第四端122，变形部11的第一端111与前一个安装部12的第四端122连接，变形部11的第二端112与后一个安装部12的第三端121连接，以围成环形管。扩张管中的变形部11起到径向变形的作用，安装部12起到供变形部11安装和定位的作用；变形部11和安装部12交替分布，使得变形部11在变形时，沿径向的变形量更均匀。
最佳地，在初始状态，所有变形部的内周壁和安装部12的内周壁位于同一圆周面上，内周壁位于同一个圆周上，便于手术器械的远端的头部沿着该圆周面顺利地伸入扩张管的内孔中，手术器械沿其周向能够抵接在整个内圆周面上，便于对变形部11施加径向扩张力，进而使变形部11在径向被撑开；所有变形部11的外周壁和安装部12的外周壁位于同一圆周面上，外周壁位于同一个圆周上，使扩张管插入血管内，在血管内移动时，扩张管的外周弧面与血管内壁接触，防止对血管内壁产生划伤作用。
对于变形部11和安装部12的设置数量不做限定，例如，变形部11还可以为一个，安装部12也为一个；或者变形部11为一个，安装部12为两个，或者变形部11和安装部12为其他数量都可以，变形部11的设置数量可以与安装部12的设置数量相同，也可以不相同，具体设置数量根据需要而定。
另外，变形部11与安装部12沿扩张管周向还可以不呈交替分布。例如，部分变形部11的第一端111与安装部12相邻，第二端112与另一个变形部11相邻，相邻的两个变形部11中，前一个变形部11的第一端111与后一个变形部11的第二端112连接，变形部11在受扩张管径向的扩张力时，相邻的两个变形部11的变形量更大，更容易变形。
对于变形部11的结构而言，如图4所示，变形部11沿扩张管径向包括从内向外依次层叠分布的内层段11a、至少一个中间段11b及外层段11c；内层段11a、至少一个中间段11b及外层段11c依次通过弯折的圆弧段11d连接，以呈S走向弯折。
例如，如图4所示，中间段11b为一个，则内层段11a、中间段11b及外层段11c沿扩张管径向层叠分布，内层段11a的自由端作为上述的第一端111，外层段11c的自由端作为上述的第二端112。当手术器械穿在变形部11的内孔中时，手术器械对变形部11的内孔施加径向扩张力，在该扩张力下，内层段11a的第一端111和外层段11c的第二端112沿扩张管的周向朝向两端拉伸铺展开，将扩张管的内孔撑开，增大扩张管的内孔直径，以供手术器械穿过。变形部11的最大变形量是将内层段11a和外层段11c拉伸开，不再层叠分布在中间段11b的两侧，以使扩张管的内孔直径达到最大值。
对于中间段11b而言，中间段11b的数量还可以为两个、三个、四个等等，相邻两个中间段11b通过圆弧段11d弯折连接，在初始状态下，多个中间段11b层叠分布，内层段11a层叠在最内层的中间段11b的内侧，外层段11c层叠在最外层的中间段11b的外侧。此实施方式中，将多个中间段11b、内层段11a和外层段11c沿扩张管的径向层叠，可以将扩张管的内孔的直径设置的更小，并且 不凸出占用扩张管的径向厚度空间，从而使该扩张管的内孔的变形范围更大，能适应更大范围内不同直径的血管的扩张，及更大范围内不同尺寸的手术器械穿过。
作为变形，上述的内层段11a、多个中间段11b及外层段11c除了沿扩张管的径向层叠分布，还可以沿扩张管的周向层叠分布，此时整个变形部11沿扩张管的周向呈S走向的波浪线分布，当变形部11受到扩张管进行的扩张力时，变形部11的内孔被撑开，也能够实现上述的功能。
上述的变形部11可以采用高分子塑料制成，对应地扩张管一般从初始状态切换至扩张状态，同样在使用中，也能在血管壁的作用下实现回缩，作为一次性扩张管使用。
为了使得扩张管重复利用，最佳地，变形部11采用变形材料制成；变形部11可在扩张状态与初始状态之间切换；在初始状态，扩张力撤销，变形部11沿扩张管径向收缩复位。
例如，在图4中，当手术器械穿过或退出扩张管后，对扩张管的扩张力撤销，此时扩张管在自身变形材料的作用下，复位到起始状态，即第一端111和第二端112沿扩张管的周向缩回，使内层段11a、中间段11b及外层段11c呈层叠分布，并呈S走向分布。
例如，变形材料采用形状记忆材料制成，当器械对扩张管的径向扩张力撤销，在形状记忆材料的形状记忆作用下，使内层段11a、中间段11b及外层段11c保持S走向的分布。优选地，形状记忆材料为形状记忆合金材料，在变形部11制成后，就保持上述的S走向。变形材料还可以为现有的其他弹性材料。
实施例2
本申请提供一种血管鞘装置，如图1至图14所示，其包括外壳26、止血阀2及扩张管1。其中，止血阀2密封地设在外壳26的近端的开口上；扩张管1的近端安装在外壳26的远端开口上，该扩张管1采用实施例1所描述的扩张管。
比如，如图5a、图5b及图11所示，外壳26的远端开口的外壁面上具有外螺纹，扩张管1的近端开口上固定有固定环28，外壳26的远端上螺纹连接有锁紧部件27，固定环28的近端为扩口结构，扩口结构的扩口端套在外壳26的远端上且被夹持在锁紧部件27与外壳26的远端之间，以实现扩张管1与外壳26的远端的连接。
如图2所示，为了避免扩张管1扩张后，变形部11的弯折段对血管有划伤作用，如图1所示，血管鞘还包括套在扩张管1外的可变形的软管13，扩张管1受所述软管13的径向束缚力而趋于保持径向收缩的初始状态，即扩张管1处于被动变形回缩。
比如，软管13为具有收缩和扩张功能的高分子软管，比如，硅胶管，乳胶管，PU管等。软管具有很好的弹性，当器械穿过扩张管1时，对扩张管1扩张后，软管13也被撑大，能够对扩张管1起到包裹效果，其光滑的外表面与血管壁接触，对血管起到保护作用；当器械退出扩张管1后，软管13自动回缩，对扩张管1施加径向束缚力，使扩张管1在径向收缩复位。
优选地，软管13的部分外壁面与安装部12通过胶水粘接，而与变形部11的外壁面不粘胶，使变形部11发生变形时，软管13具有相应的变形能力，以适应变形部11的变形。软管13与安装部12之间用胶水粘接，保证软管13在使用时不会因为摩擦而产生褶皱影响其功能，其中胶水的粘接方式可以为直线不间断型、直线间断型(即虚线型)、绕轴线的螺旋形、与轴不平行的环形等。
进一步地，为了使软管13在血管内移动时，对血管壁的摩擦力小，软管13的外周壁上涂有亲水涂层，以减少软管13的外壁与血管壁之间的摩擦力，起到润滑作用，降低软管13对血管壁的摩擦，进一步地起到保护血管的作用。
血管鞘装置还包括设在扩张管1的远端的头部帽14；在图2和图3中示意出头部帽14的第一种实施方式，头部帽14上设有至少一个第一变形缝141，以及设在第一变形缝141的近端和/或远端的至少一个连接部，以将第一变形缝141两侧的头部帽14的部分连接；头部帽14通过所述第一变形缝141随变形部11的扩张而径向撑开，即在径向有变形量，以供手术器械穿过。
所有第一变形缝141沿扩张管1周向间隔分布在头部帽14上，例如，第一变形缝141为三个，三个第一变形缝141均匀地分布在头部帽14的周向上，沿周向将头部帽14分为三个部分，分别为第一部分、第二部分、第三部分，例如，每个第一变形缝141内的远端(和/或近端)处设有连接部，以将头部帽上相邻两部分连接。第一变形缝141的设置数量还可以为其他，比如一个、两个、四个、五个、六个等，具体设置数量不做限定。第一变形缝141的设置，为了保证血管鞘在未扩张之前能够保证头部帽14的外形，以插入血管内并在血管内移动，使扩张管1在血管内滑动到位以建立所需的通道，并且在手术器械穿过时，第一变形缝141为头部帽14在径向变形提供变形量，便于头部帽 14容易被撕开，不会阻挡器械的通过。
可以设置多个连接部，以将第一变形缝141两侧的头部帽14的部分连接。
如图3所示，沿扩张管1的轴向，所述第一变形缝141的长度不小于连接部的长度，确保手术器械穿过时，头部帽14的变形空间大，更容易被撕开。
例如，第一变形缝141的呈为一字型、L型、S型、Z型，或者其他形状的变形缝均可以，具体不做限定，根据需要来选取。
头部帽14与扩张管1的远端的连接方式有多种，例如，如图3所示，头部帽14的近端和扩张管1的安装部12的远端中的一个上，设有沿扩张管1轴向延伸的卡槽151，另一个上设有沿扩张管1轴向延伸的卡合凸起152，卡合凸起152一一对应地卡接在卡槽151内，从而实现安装部12与头部帽14的连接。
比如，头部帽14的近端设有卡槽151，扩张管1的安装部12的远端上设有卡合凸起152，或者，卡槽151和卡合凸起152的位置可以对调，通过卡合凸起152与卡槽151的卡接关系，实现头部帽14与扩张管1的安装部12的远端连接。另外，头部帽14与安装部12的远端除了卡槽151和卡合凸起152的插接配合外，还可以将卡槽151和卡合凸起152熔接或粘接在一起，或者采用点焊或者焊接，或者现有的其他固定方式均可，或者这些固定方式同时使用。
较佳地，在头部帽14上熔有铂铱合金材料，起到显影的效果，便于在血管内，更容易捕捉到扩张管1在人体内的位置。另外，如图3所示，头部帽14的远端呈圆角形，使其在进入和退出血管时更加顺利，对血管的伤害也小。
如图3所示，相邻两个卡槽151之间形成第一凸起，第一凸起与头部帽14之间形成台阶面，上述的软管13的远端套在该第一凸起上，且软管13的远端端面抵接在台阶面上，软管13与第一凸起之间采用胶水不连续粘接固定，以使头部帽14的第一变形缝141处和软管13在扩张时具有可变形量。
例如，软管13的远端与头部帽14的第一凸起之间通过胶水粘接，以形成连接点，其中连接点不限于全部粘接，也包括局部连接，即在变形缝的141的两侧的头部帽的部分上粘接，变形缝141的存在，以保证软管13在径向扩张时有足够的变形量。
如图15a和图15b所示头部帽14的第二种实施方式，其与图3所示的头部帽14的结构不同在于：在头部帽14的外壁面上设有至少一个容纳槽142，用于容纳胶水，以使头部帽14与软管13粘接时更精准。例如，容纳槽为多个，比如，容纳槽为两个、三个、四个、五个等，多个容纳槽沿头部帽14的周向间隔分布，从而使软管13的远端与容纳槽内的胶水形成间隔式的局部粘接，以避免软管13在扩张时被撕裂。
如图15a所示，还包括熔接于所述卡合凸起152和卡槽151的连接处的显影环4，所述显影环4上设有对应于所述第一变形缝141的第二变形缝41，使手术器械穿过卡合凸起152和卡槽151时，显影环4也具有径向扩张的变形量。
例如，卡合凸起152和卡槽151插接配合后，将显影环4套在卡合凸起和卡槽外，并将卡合凸起152、卡槽151、显影环4熔接在一起。比如，显影环4固定在卡合凸起、卡槽内，或者固定在卡合凸起和卡槽的外壁面上。
如图17a及图17b所示，扩张管1包括由近端朝向远端一体成型的安装段16和主体段17；在未受径向扩张力的初始状态下，安装段16的近端的变形部11呈扩张状态，主体段17的变形部11呈S走向弯折分布，安装段16由其近端朝向远端呈外径逐渐缩小的锥形管(呈喇叭状结构)，以过渡成型在主体段17的近端上；扩张管1的近端通过安装段16与外壳26的远端连接；软管13套在扩张管1的近端外。例如，采用塑形方式，使安装段16形成上述的锥形管。
由于扩张管1的安装段16的变形部11从其近端到远端的撑开程度逐渐减小，以使安装段16的近端与其他部件连接，其他部件不随变形部11的径向撑大或变小而变形，同时，确保主体段17的变形部11在未受到径向扩张力时，保持收拢状态而使主体段17的外径小，便于进入血管内，即安装段16起到将其他部件与主体段17连接的过渡作用，不会影响主体段17的径向撑开或收拢的变形过程。
如图5a和图5b所示，血管鞘装置还包括设在所述扩张管1的近端上的固定机构；固定机构包括与所述安装段16插接配合的固定环28，所述固定环28套接在所述外壳26的远端外，所述软管13的近端套在所述固定环28外；及锁紧部件27，锁紧部件27配合在所述外壳26的远端外，且将所述固定环28和软管13的近端夹持在所述锁紧部件27与所述外壳26之间，以实现安装段16的近 端与外壳26的远端之间的连接。
优选地，锁紧部件27为螺母，螺纹配合在外壳26的远端上，以将安装段16的近端、固定环28的近端及软管13的近端夹持而锁紧在外壳26的远端上。或者，锁紧部件27还可以为其他结构，例如，螺栓或螺钉，或者法兰盘等。
进一步地，固定环28的近端伸出安装段16的近端外，软管13的近端套在安装段16和固定环28的近端外，可以采用胶将软管13的近端内壁粘接在安装段16和固定环28的外壁面上，加强软管13与固定环28、安装段16之间连接的密封性。软管13的近端内壁可以全部粘接在对应的安装段16和固定环28的外壁面上，也可以部分粘接在安装段16和固定环28的外壁面上。
安装段16与固定环28之间的配合方式，可以为粘接方式，或者其他固定方式，图11示意出固定环28的第一种实施方式，图16a示意出固定环28的第二种实施方式，先以图11中的固定环28为例来说明。
如图11和图17a所示，所述安装段16由所述扩张管1的近端经塑形而成，固定环28上设有适于供安装段16上的安装部12一一对应嵌入的安装槽282，通过安装段16上的安装部12一一对应地插接在安装槽282内，以实现安装段16和固定环28的配合。
优选地，固定环28的近端呈朝向外壳26的近端扩大的扩口部283，扩口部283被夹持在所述外壳26与锁紧部件27之间，便于固定环28被夹持在外壳26与锁紧部件27之间。进一步地，扩张管1采用高分子塑料，再用高分子粘接剂将固定环28与安装段16粘接固定，从而使固定环28与安装段16的完美贴合，以保障连接的密封性。
图16a所示的固定环28与图11所示的固定环28的结构，不同之处在于：固定环28的远端呈与锥形管配合的锥形部281；锥形部281上设有适于供所述安装段16上的安装部12一一对应嵌入的安装槽282；锥形部281的远端靠近主体段17的近端，从而增大固定环28与安装段16之间的接触面积，增大对扩张管1的支撑力，使扩张管1不会在使用中变形以影响手术，使固定环28与扩张管1的连接更牢固，在使用时器械回撤过程中增强对扩张管1的支撑力，扩张管1不会因为阻力大而产生弯折。
优选地，固定环28的远端上设有至少一个沿其轴向延伸的第三变形缝2811，保证固定环28能够在径向方向有变形量，且能够自动回缩，以适应于变形部11的径向增大或自动回缩的过程。
进一步地，如图16b所示，固定环28的远端的内壁面呈由其近端朝向远端的扩口，例如，通过将固定环28的远端的不同位置处的厚度减薄，以形成扩口，以使器械穿过固定环28进入扩张管1内后，从扩张管1退出时，扩口的设置不会卡住该器械。
对于止血阀2而言，如图5、图6及图7所示，止血阀2包括第一密封件21、第二密封件22、多个密封垫23及底座25。
第一密封件21包括第一环形基体212，成型在第一环形基体212的远端上且朝向第一环形基体212的远端凸出的至少一个密封凸起213，密封凸起213的端面上设有第一密封通道211；密封凸起213的两侧壁呈坡面，坡面由密封凸起213的远端朝向其近端的根部倾斜，密封凸起213的两侧壁受其远端处的介质压力而挤压密封凸起213，以迫使第一密封通道211趋于关闭。
也即，密封凸起213远端的介质对密封凸起213的两个侧壁施加介质压力时，将密封凸起213的两个侧壁挤压靠拢，使第一密封通道211趋于关闭，进而起到止血的功能。
例如，如图7所示，所述密封凸起213包括四个分支凸台，所述分支凸台构成十字凸起，每个分支凸台的两侧壁分别呈一个坡面，所述十字凸起端面上的第一密封通道211构成十字狭缝。
在图7中，每个坡面由各自所对应的分支凸台的端面朝向其根部向下倾斜，当图7中的坡面上有血液或溶液时，血液或溶液沿着坡面的倾斜角度，对坡面施加压力，该压力在第一环形基体212的径向和轴向均匀分量，径向分量迫使坡面挤压分支凸台，每个分支凸台的两侧的坡面均朝向缝挤压各自对应的分支凸台，从而使十字狭缝趋于密封住或关闭，将血液截止在密封凸起213的远端一侧，不会经止血阀2流出人体外。同时，十字狭缝还便于保证后续器械更容易穿过第一密封件21。
对于坡面而言，如图7所示，优选地，坡面包括第一倾斜面2131和第二倾斜面2132，第一倾斜面2131的近端与第二倾斜面2132的远端连接，第一倾斜面2131的远端连接于密封凸起213的端面，第二倾斜面2132的近端成型在第一环形基体212上，第一倾斜面2131相对于密封凸起213的端面的倾斜角度与所述第二倾斜面2132相对于所述密封凸起的端面的倾斜角度不同。
例如，第一倾斜面2131的倾斜角度大于第二倾斜面2132的倾斜角度，使得第一倾斜面2131处受到的血液压力在径向分量大于第二倾斜面2132处受到的血液压力在径向的分量，使得第一倾斜面2131处更集中地挤压分支凸台，进一步地确保密封凸起213的密封性。作为变形，第一倾斜面2131 的倾斜角度小于第二倾斜面2132的倾斜角度。
当然，作为变形，十字狭缝可以被替换为圆形通孔，或者其他形状的通孔，只需第一密封通道211的轴线与扩张管1的轴线重合即可。对于密封凸起213而言，还可以为一字型凸起，或者米字型凸起，或者其他形状的凸起，只需密封凸起213的每个分支凸台的两侧壁呈上述坡面即可。
第二密封件22的结构与第一密封件21的结构类似，如图8所示，第二密封件22包括第二环形基体222，成型在第二环形基体222的内孔中的第二凸起223，第二凸起223朝向第二环形基体222的远端凸出，第二凸起223上设有第二密封通道221，第二密封通道221与第一密封通道211同轴连通。
例如，如图8所示，第二凸起223呈碗状或球形状，第二凸起223的中心处设第二密封通道221。
比如，第二密封通道221为十字狭缝或米字型狭缝，或者通孔。第二密封件22层叠分布在第一密封件21的近端一侧，进一步地形成第二道密封，来辅助第一密封件21进行进一步的密封。
优选地，第二密封件22还包括至少一个第一加强筋225，如图8所示，设置四个第一加强筋225，四个第一加强筋225均匀分布，每个第一加强筋225的一端固定在所述第二凸起223的远端的外壁面上，另一端固定在所述第二环形基体222的内壁面上，增加第二凸起223的强度。当然第一加强筋225的数量可以为其他，例如一个、两个、三个、五个等，具体设置数量根据需要来选取。
如图6和图9a所示，止血阀2还包括层叠且夹设在第一密封件21和第二密封件22之间的密封垫23，密封垫23上设置第三密封通道231，第三密封通道231与第一密封通道211、第二密封通道221分布在扩张管1的轴线上，以在第一密封件21和第二密封件22之间形成多道密封。每一个密封垫23形成一道密封，例如，密封垫23为两个，形成两道密封。上述的密封件的外周边缘紧密地抵接在外壳26的内孔壁面上，以与外壳的内孔壁形成密封连接。
优选地，如图9a所示，密封垫23呈圆形板块，密封垫23的中心处设有第三密封通道231，第三密封通道231可以为通孔和/或缝，以进一步地加强密封作用。较佳地，密封垫23、第一密封件21、第二密封件22均采用橡胶材料制成，密封垫23的第三密封通道231为通孔，通孔的直径小于导丝的外径，能够在导丝通过时起到密封作用，且较软的硅胶材质的密封垫23具有很好的弹性，使圆孔的直径扩张到更大范围内，供大直径的器械通过。
优选地，第三密封通道231包括通孔及分布在通孔的外周上的至少一个切割槽234，切割槽234的内腔与所述通孔连通。
例如，如图9b所示，第三密封通道231包括设于所述密封垫23远端端面的十字型切割槽和近端端面的“X”型切割槽或设于所述密封垫23远端端面的“X”型切割槽和近端端面的十字型切割槽，所述十字型切割槽和“X”型切割槽一起，使切割槽呈米字结构，还包括与所述米字结构的切割槽连通且位于所述米字结构的切割槽中部的通道。
当手术器械通过第三密封通道231的通孔时，在手术器械的径向撑开力作用下，很容易从切割槽位置处将密封垫径向变形撑开，以减少手术器械与第二密封件22的接触面积，由原来的面与面的接触变成面与线或点的接触，减少手术器械通过第三密封件的摩擦力，以供手术器械通过。
对于切割槽234而言，还可以为一字型，或者其他形状的切割槽234，具体根据需求来选取，不仅限于上述的米字型，还可以为十字型。或者，切割槽234还可以仅设在密封垫23的远端端面或者近端端面上。当切割槽234为多个时，部分切割槽234分布在密封垫23的近端端面上，部分切割槽234分布在密封垫23远端端面上；较佳地，位于同一端面上的多个切割槽234均匀地分布在通道的外周。
作为变形，第三密封通道231还可以为类似上述第一密封通道211或第二密封通道221的狭缝。
此外，密封垫23的远端端面上设有多个第二加强筋233，以增强第二密封件22和密封垫23的支撑力，并减少与器械的接触面积，从而减小摩擦力。上述的第一密封件21、密封垫、第二密封件22由远端朝向近端层叠分布。
对于底座25而言，如图5、图6及图10所示，底座25的近端端面上设有径向凸出的环形凸缘251，底座25嵌装在外壳26的近端开口处，环形凸缘251紧密地勾在外壳26的近端端面上，底座25的外周壁上径向凸出多个间隔分布的卡接凸起252；对应地，外壳26上设有供卡接凸起252插接的卡孔265，卡接凸起252插接在卡孔内，实现底座25与外壳26的装配，使底座25与外壳26无需增加任何粘接剂的情况下，将整个止血阀2密封连接。底座25上设置导向通道，导向通道与第一密封通道211、第二密封通道221、第三密封通道231同轴分布。
底座25的远端的端面抵接在第二密封件22的第二环形基体222的近端端面上；如图5a和图5b所示，外壳26的内壁面上设有第一环形台阶261，第一密封件21的远端端面抵接在第一环形台阶261，从而实现第一密封件21、第二密封件22及密封垫23在外壳26与底座25上的安装配合。
可选地，如图10所示，底座25的远端端面上设有圆锥形的导向头253，导向头伸入第二密封件22的第二环形基体222的内孔，一方面对底座25的安装起到导向作用；另一方面对器械依次穿过底座25的导向通道进入第二密封件22的第二密封通道221起到导向作用。
如图5a、图5b及图6所示，为了使相邻两个密封件更好地紧密地层叠分布，起到更好的密封作用。止血阀2还包括第一支撑环241和第二支撑环242，其中第一支撑环241夹设在两个密封垫23之间，对密封垫23起到支撑作用。
可选地，密封垫23包括圆形本体，及成型在圆形本体的外周壁上的配合体，配合体的纵向截面形状为梯形，梯形的短边成型在圆形本体的外周壁上，梯形的长边作为密封垫23的外周壁，并与外壳26的内孔壁配合；对应地，第一支撑环241的外周壁的近端和远端上分别设有一个第三倾斜面2411；两个密封垫23的梯形的斜边232分别与一个第三倾斜面2411的倾斜角度相同并紧密地抵接，第三倾斜面2411对梯形的斜边232起到挤压作用力，使密封垫23的外周壁进一步地紧密抵接在外壳26的内孔壁上，进而使密封垫23的外周壁与外壳26的内孔壁保持密封状态。
如图5a、图5b所示，第二支撑环242设在密封垫23与第二密封件22之间，对第二密封件22和密封垫23起到支撑作用。
可选地，第二密封件22的第二环形基体222的远端上还设导向筒224，上述的第二凸起223位于导向筒内；上述的第二支撑环242套在导向筒外，第二支撑环242的近端抵接在第二环形基体222的远端端面上，第二支撑环242的远端端面上设有与密封垫23的梯形的斜边232抵接配合的第四倾斜面2421，第四倾斜面2421所起的作用与第三倾斜面2411所起的作用相同，均是对密封垫23的梯形斜边施加挤压力，进一步地确保密封垫23的外周壁与外壳26的内孔壁保持密封抵接。
同样地，上述的第一密封件21的近端端面上设有与其相邻的密封垫23的梯形的斜边232配合的第五倾斜面。
作为变形实施方式，第一支撑环241和第二支撑环242上还可以不设置上述的倾斜面，密封垫23上不设置对应的梯形斜边，支撑环只是起到支撑作用，第一密封件、第二密封件及密封垫的外周壁紧密抵接在外壳的内孔壁上，实现密封连接。
作为变形，上述的第二密封件22或密封垫23可以不设置，只需设置上述的底座25和第一密封件21即可对实现上述的止血效果。或者，底座都可以不设置，只需设第一密封件，第一密封件的外周边缘可以直接密封卡接在外壳的内孔壁的圆周槽内，实现第一密封件与外壳的密封安装。进一步地，止血阀2还可以采用其他结构的单向阀，而不限于上述提及的止血阀2。
可选地，如图5a所示，外壳26的侧壁上设有连接通道262；如图1所示，还包括三通阀门263，三通阀门263与连接通道262之间通过第一管路264连接，通过三通阀门263向扩张管1内输送所需的液体。比如，第一管路264为材质较软的管材，比如PU管或硅胶管。三通阀门263可以选三通旋塞阀，其所起的作用是在血管鞘使用前，排空扩张管1内的气体，以及在使用中对手术器械进入扩张管1内带入的空气进行排出。
实施例3
本申请实施例提供一种血管鞘装置，其与实施例2中提供的血管鞘装置相比，不同之处在于：
扩张管不包括安装部12，仅包括变形部11，变形部11可以为一个或者两个，或者更多个。当变形部11为一个时，变形部11的第一端111和第二端112形成闭合环，当器械穿设在扩张管1内，对变形部11施加径向扩张力时，变形部11的径向被撑开，以改变其内孔直径。当变形部11为多个时，任意相邻两个变形部11的第一端111与另一个变形的第二端112连接，以形成环形管，扩张管1沿其周向全部采用变形部11形成，以进一步地增大扩张管的径向变形量。
实施例4
本申请提供一种血管鞘装置与预扩器的配合结构，如图1和图13所示，包括：上述实施例2或实施例3中提供的血管鞘装置；以及预扩器。如图13所示，预扩器包括预扩管31，及设在预扩管31的远端上第二头部32，第二头部32上的至少部分的外径大于扩张管1的头部帽的远端的内径，预扩管及第二头部32适于在扩张管1内滑动，沿径向以撑开扩张管的头部帽14。
此结构的预扩器，由于第二头部32的至少部分的外径大于扩张管1的头部帽14的远端的内径，当扩张管1在血管内滑动到位后，先用预扩器的预扩管和第二头部32在扩张管1内滑动，第二头部32的至少部分穿过扩张管1的头部帽14的远端，将扩张管1的头部帽14沿径向撑开，之后将预扩器从扩张管1内退出，再将手术器械穿过扩张管1的头部帽14时，手术器械受到头部帽14的径向 作用力小，便于手术器械穿过头部帽14，对手术器械的头部起到保护作用。
优选地，第二头部32上的至少部分上设有沿其轴向延伸的回流通道，回流通道的近端和远端均呈开口。
当预扩器的第二头部32对扩张管1的头部帽14进行预扩之后，第二头部32位于头部帽14的远端外的血管壁内；即使血管内的部分血液流到第二头部32的近端一侧的扩张管1与预扩管之间的缝隙内时，并且扩张管1的近端上设有止血阀2，由于第二头部32的至少部分处设置回流通道，使回流通道两侧的血液连通，即上述缝隙的血液压力与第二头部32的远端一侧的血液压力一致，并在止血阀2对缝隙的近端止血的作用下，缝隙内的血液经回流通道流入第二头部32的远端一侧，回流到血管内，降低人体血管内部分血液随着预扩器退出而带出人体外的量。
对于回流通道而言，如图14所示，回流通道为设在第二头部的上述的至少部分的外周壁上的径向向内凹陷的回流槽321，回流槽321可以为一个，也可以为两个，具体设置数量可以根据实际需求而设置。
作为变形，回流槽321可被替换为通孔，通孔的两端呈开口，也能够起到降低人体血管内的部分血液被带出人体外的量。
优选地，如图14所示，第二头部32包括呈圆锥环型的第一段322和成型在第一段322的近端上的第二段323，所述第一段322的中部外径大于其两端的外径；回流通道至少设在所述第一段322的中部上；第二段323的近端套接在预扩管31的远端外；第二段323的外径小于或等于第一段322的近端的外径。
第二段323的设置，将第一段322的近端与扩张管1的远端形成过渡连接，圆锥环型的第一段322，使第二头部32的远端便于穿入扩张管内，第二头部32的末端更容易退出扩张管；并且将回流通道设在第一段322的中部上，便于加工。
回流槽可以仅在第一段322的中部设置，也可以进一步地延伸至第一段322的近端和远端，当第二头部32穿设在扩张管1的内壁时，确保第一段322的近端和远端两侧的血液连通，使第一段322的近端一侧的血液回流到第一段322的远端一侧的血管内。
作为变形，第二头部32还可以仅设置第一段322，不设置第二段323，或者第一段322呈圆柱环，第二头部32沿其轴向的不同位置处的外径均一致，上述的回流通道贯穿第二头部32的近端和远端。
优选地，第二头部32的外径大于预扩管的外径，在预扩过程中，主要是第二头部32对头部帽14施加径向撑开力，预扩管在扩张管1内滑动，起到对第二头部32的支撑作用，便于医生操作预扩管的近端上的手柄，以驱动第二头部32在扩张管1和头部帽14内滑动。
更佳地，预扩管的外径小于扩张管1的内径，第二头部32的外径大于扩张管1和头部帽14的内径。或者，预扩管和第二头部32的外径小于扩张管1在未撑开时的内径，减少其在扩张管1内滑动时所受到的摩擦力，但第二头部32的外径大于头部帽14的内径。
如图18所示，为了增强预扩管31的硬度，优选地，预扩管31内设有多个沿其轴向延伸的腔体，设在腔体内的金属丝311，金属丝311插接在第二头部内，多个金属丝围绕在预扩管31的内孔的外周，内孔供牵引丝穿过，以牵引预扩器进入血管内，及在预扩之后，牵引预扩器从血管内退出。
实施例5
本申请提供一种预扩器，如图13所示，预扩器包括预扩管31，及设在预扩管31的远端上第二头部32，第二头部32上的至少部分的外径大于扩张管1的头部帽的远端的内径，预扩管及第二头部32适于在扩张管1内滑动，沿径向以撑开扩张管的头部帽14。
此结构的预扩器，由于第二头部32的至少部分的外径大于扩张管1的头部帽14的远端的内径，当扩张管1在血管内滑动到位后，先用预扩器的预扩管和第二头部32在扩张管1内滑动，第二头部32的至少部分穿过扩张管1的头部帽14的远端，将扩张管1的头部帽14沿径向撑开，之后将预扩器从扩张管1内退出，再将手术器械穿过扩张管1的头部帽14时，手术器械受到头部帽14的径向作用力小，便于手术器械穿过头部帽14，对手术器械的头部起到保护作用。
本实施例的预扩器的其它细节与实施例4的血管鞘装置与预扩器的配合结构中所采用的预扩器相同，在此不再赘述。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本申请的保护范围之中。

Claims (51)

  1. 一种扩张管，其特征在于，包括沿其周向分布的至少一个变形部(11)，任一所述变形部(11)上沿扩张管周向的第一端(111)朝向其的第二端(112)呈S走向弯折分布，以围成环形；
    所述变形部(11)可在受扩张管径向的扩张力时，沿扩张管径向撑开而处于扩张状态。
  2. 根据权利要求1所述的扩张管，其特征在于，还包括至少一个安装部(12)，所述变形部(11)的第一端(111)和第二端(112)分别与其相邻的变形部(11)或安装部(12)连接，以使所有所述变形部(11)和安装部(12)围成环形。
  3. 根据权利要求2所述的扩张管，其特征在于，所述变形部(11)和所述安装部(12)沿扩张管的周向交替分布。
  4. 根据权利要求2所述的扩张管，其特征在于，在初始状态，所有所述变形部的内周壁和所述安装部(12)的内周壁位于同一圆周面上，所有所述变形部(11)的外周壁和所述安装部(12)的外周壁位于同一圆周面上。
  5. 根据权利要求1所述的扩张管，其特征在于，所述变形部(11)为至少两个，沿扩张管周向，相邻两个变形部(11)中，前一个变形部(11)的第一端(111)与后一个变形部(11)的第二端(112)连接。
  6. 根据权利要求1-5中任一项所述的扩张管，其特征在于，所述变形部(11)沿扩张管径向包括从内向外依次层叠分布的内层段(11a)、至少一个中间段(11b)及外层段(11c)；所述内层段(11a)、至少一个中间段(11b)及外层段(11c)依次通过弯折的圆弧段(11d)连接，以呈S走向弯折。
  7. 根据权利要求1-5中任一项所述的扩张管，其特征在于，所述变形部(11)沿扩张管(1)周向包括层叠分布的内层段、至少一个中间段及外层段；所述内层段、至少一个中间段及外层段依次通过弯折的圆弧段连接，使所述变形部(11)沿扩张管(1)的周向呈S走向的波浪线分布。
  8. 根据权利要求1-5中任一项所述的扩张管，其特征在于，所述变形部(11)采用变形材料制成；所述变形部(11)可在扩张状态与初始状态之间切换；在初始状态，所述扩张力撤销，所述变形部(11)沿扩张管径向收缩复位。
  9. 一种血管鞘装置，其特征在于，包括
    外壳(26)；
    止血阀(2)，密封地设在所述外壳(26)的近端的开口上；
    扩张管(1)，安装在所述外壳(26)的远端开口上，所述扩张管(1)为权利要求1-8中任一项所述的扩张管。
  10. 根据权利要求9所述的血管鞘装置，其特征在于，还包括套在所述扩张管(1)外的可变形的软管(13)，所述扩张管(1)受所述软管(13)的径向束缚力而趋于保持径向收缩的初始状态。
  11. 根据权利要求10所述的血管鞘装置，其特征在于，至少部分所述扩张管(1)的安装部(12)与所述软管(13)通过胶水粘接。
  12. 根据权利要求10所述的血管鞘装置，其特征在于，还包括设在所述扩张管(1)的远端上的头部帽(14)；所述头部帽(14)上设有至少一个第一变形缝(141)，以及设在所述第一变形缝(141)内的至少一个连接部，以将所述第一变形缝两侧的所述头部帽的部分连接；所述头部帽(14)通过所述第一变形缝(141)随所述变形部(11)的扩张而径向撑开。
  13. 根据权利要求12所述的血管鞘装置，其特征在于，所述连接部为至少两个，所述第一变形缝(141)的长度不小于所述连接部的长度。
  14. 根据权利要求12所述的血管鞘装置，其特征在于，所述头部帽(14)的近端和所述扩张管(1)的安装部(12)的远端中的一个上设有沿扩张管(1)轴向延伸的卡槽(151)，另一个上设有沿扩张管(1)轴向延伸的卡合凸起(152)，卡合凸起(152)一一对应地卡接在卡槽(151)内，而使所述头部帽(14)与所述安装部(12)连接。
  15. 根据权利要求14所述的血管鞘装置，其特征在于，所述头部帽(14)上熔有铂铱合金材料；或者，还包括熔接于所述卡合凸起(152)和卡槽(151)的连接处的显影环(4)，所述显影环(4)上设有对应于 所述第一变形缝(141)的第二变形缝(41)。
  16. 根据权利要求14所述的血管鞘装置，其特征在于，所述头部帽(14)的外壁面上设有至少一个容纳槽(142)，用于供胶水容纳，以至少使所述头部帽(14)在容纳槽(142)处与所述软管(13)的内壁胶粘连接；或所述头部帽(14)上相邻两个卡槽(151)之间形成第一凸起，第一凸起与头部帽(14)之间形成台阶面，所述软管(13)的远端套在该第一凸起上，且软管(13)的远端端面抵接在台阶面上，软管(13)与第一凸起之间采用胶水不连续粘接固定。
  17. 根据权利要求10所述的血管鞘装置，其特征在于，所述软管(13)的外周壁上涂有亲水涂层。
  18. 根据权利要求10所述的血管鞘装置，其特征在于，所述扩张管(1)包括由近端朝向远端一体成型的安装段(16)和主体段(17)；在未受径向扩张力的初始状态，所述安装段(16)的近端的变形部(11)呈扩张状态，主体段(17)的变形部呈S走向弯折分布，所述安装段(16)由其近端朝向远端呈外径逐渐缩小的锥形管，以过渡成型在所述主体段(17)的近端上；
    还包括设在所述扩张管(1)的近端上的固定机构；所述固定机构包括与所述安装段(16)插接的固定环(28)，所述固定环(28)套接在所述外壳(26)的远端外，所述软管(13)的近端套在所述固定环(28)外；及
    锁紧部件(27)，配合在所述外壳(26)的远端外，且将所述固定环(28)和软管(13)的近端夹持在所述锁紧部件(27)与所述外壳(26)之间。
  19. [根据细则91更正 03.08.2021]　
    根据权利要求18所述的血管鞘装置，其特征在于，所述固定环(28)的远端呈与所述锥形管配合的锥形部(281)，所述锥形部(281)上设有适于供所述安装段(16)上的安装部(12)一一对应嵌入的安装槽(282)。
  20. [根据细则91更正 03.08.2021]　
    根据权利要求19所述的血管鞘装置，其特征在于，所述固定环(28)的近端呈朝向外壳(26)扩大的扩口部(283)，所述扩口部(283)被夹持在所述外壳(26)与锁紧部件(27)之间。
  21. [根据细则91更正 03.08.2021]　
    根据权利要求18所述的血管鞘装置，其特征在于，所述锁紧部件(27)螺纹配合在所述外壳(26)的远端上；和/或至少部分所述软管(13)与所述安装段(16)、固定环(28)胶粘连接。
  22. [根据细则91更正 03.08.2021]　
    根据权利要求18所述的血管鞘装置，其特征在于，所述固定环(28)的远端上设有至少一个沿其轴向延伸的第三变形缝(2811)。
  23. [根据细则91更正 03.08.2021]　
    根据权利要求22所述的血管鞘装置，其特征在于，所述固定环(28)的远端的内壁面呈由其近端朝向远端的扩口。
  24. [根据细则91更正 03.08.2021]　
    根据权利要求9所述的血管鞘装置，其特征在于，所述止血阀(2)包括第一密封件(21)；
    所述第一密封件(21)包括第一环形基体(212)，所述第一环形基体(212)的外周壁密封地设在所述外壳(26)的内孔壁上；成型在所述第一环形基体(212)上且朝向所述第一环形基体(212)的远端凸出的至少一个密封凸起(213)，所述密封凸起(213)的端面上设有第一密封通道(211)；
    所述密封凸起(213)的两侧壁呈坡面，所述坡面由所述密封凸起(213)的远端朝向其近端的根部倾斜，所述密封凸起(213)的两侧壁受其远端处的介质压力而挤压所述密封凸起(213)，以迫使所述第一密封通道(211)趋于关闭。
  25. [根据细则91更正 03.08.2021]　
    根据权利要求24所述的血管鞘装置，其特征在于，所述坡面包括第一倾斜面(2131)和第二倾斜面(2132)，所述第一倾斜面(2131)的近端与所述第二倾斜面(2132)的远端连接，所述第一倾斜面(2131)的远端连接于所述密封凸起(213)的端面，所述第二倾斜面(2132)的近端成型在所述第一环形基体(212)上，所述第一倾斜面(2131)相对于所述密封凸起(213)的端面的倾斜角度与所述第二倾斜面(2132)相对于所述密封凸起(213)的端面的倾斜角度不同。
  26. [根据细则91更正 03.08.2021]　
    根据权利要求24所述的血管鞘装置，其特征在于，所述第一密封通道为一字型缝或十字型缝或米字型缝。
  27. [根据细则91更正 03.08.2021]　
    根据权利要求26所述的血管鞘装置，其特征在于，所述密封凸起(213)包括四个分支凸台，所述分支凸台构成十字凸起，每个分支凸台的两侧壁分别呈一个坡面，所述十字凸起端面上的第一密封通道(211)构成十字狭缝。
  28. [根据细则91更正 03.08.2021]　
    根据权利要求24所述的血管鞘装置，其特征在于，所述止血阀(2)还包括与所述第一密封件 (21)层叠分布的第二密封件(22)；
    所述第二密封件(22)包括第二环形基体(222)，所述第二环形基体(222)的外周壁密封地设在所述外壳(26)的内孔壁上；成型在所述第二环形基体(222)的内孔中的第二凸起(223)，所述第二凸起(223)朝向所述第二环形基体(222)的远端凸出，所述第二凸起(223)上设有第二密封通道(221)，所述第二密封通道(221)与所述第一密封通道(211)连通。
  29. [根据细则91更正 03.08.2021]　
    根据权利要求28所述的血管鞘装置，其特征在于，所述第二密封件(22)还包括至少一个第一加强筋(225)，所述第一加强筋(225)的一端固定在所述第二凸起(223)的远端的外壁面上，另一端固定在所述第二环形基体(222)的内壁面上。
  30. [根据细则91更正 03.08.2021]　
    根据权利要求28所述的血管鞘装置，其特征在于，所述止血阀(2)还包括层叠且夹设在所述第一密封件(21)和第二密封件(22)之间的至少一个密封垫(23)，所述密封垫(23)上设置第三密封通道(231)，所述第三密封通道(231)与所述第一密封通道(211)、第二密封通道(221)分布在所述扩张管(1)的轴线上。
  31. [根据细则91更正 03.08.2021]　
    根据权利要求30所述的血管鞘装置，其特征在于，
    所述第三密封通道(231)包括通孔和/或至少一个切割槽(234)，当所述第三密封通道(231)包括通孔和至少一个切割槽(234)时，所述至少一个切割槽(234)分布在所述通孔的外周且与所述通孔连通；
    和/或所述密封垫(23)的远端端面和/或近端端面上设有至少一个第二加强筋(233)。
  32. [根据细则91更正 03.08.2021]　
    根据权利要求30所述的血管鞘装置，其特征在于，
    所述第三密封通道(231)的切割槽为至少两个，其中至少一个切割槽(234)分布在密封垫(23)的远端端面上，至少一个切割槽(234)分布在所述密封垫(23)的近端端面上；
    或者，所述第三密封通道(231)包括设于所述密封垫(23)远端端面的十字型切割槽和近端端面的“X”型切割槽或设于所述密封垫(23)远端端面的“X”型切割槽和近端端面的十字型切割槽，所述十字型切割槽和“X”型切割槽一起，使切割槽呈米字结构，还包括与所述米字结构的切割槽连通且位于所述米字结构的切割槽中部的通道；
    或者，所述第三密封通道与所述第二密封通道相同。
  33. [根据细则91更正 03.08.2021]　
    根据权利要求30所述的血管鞘装置，其特征在于，所述止血阀(2)包括：至少两个密封垫(23)；以及设在相邻两个密封垫(23)之间的第一支撑环(241)和/或设在所述密封垫(23)与所述第二密封件(22)之间的第二支撑环(242)。
  34. [根据细则91更正 03.08.2021]　
    根据权利要求33所述的血管鞘装置，其特征在于，所述第一支撑环(241)的外周壁的近端和远端上分别设有一个第三倾斜面(2411)，两个密封垫(23)外周处的斜边(232)分别与一个第三倾斜面(2411)的倾斜角度相同并紧密地抵接；
    和/或，第二密封件(22)的第二环形基体(222)的远端上还设导向筒(224)，所述第二凸起(223)位于导向筒内；所述第二支撑环(242)套在导向筒外，第二支撑环(242)的近端抵接在第二环形基体(222)的远端端面上，所述第二支撑环(242)的远端端面上设有与密封垫(23)外周处的斜边(232)抵接配合的第四倾斜面(2421)；
    和/或，所述第一密封件(21)的近端端面上设有与其相邻的密封垫(23)外周处的斜边(232)配合的第五倾斜面。
  35. [根据细则91更正 03.08.2021]　
    根据权利要求24-34中任一项所述的血管鞘装置，其特征在于，所述止血阀(2)还包括底座(25)；
    所述外壳(26)的内孔中设第一环形台阶(261)；所述底座(25)具有环形凸缘(251)，所述底座(25)紧密地嵌装在所述外壳(26)的近端开口处，所述环形凸缘(251)勾在所述外壳(26)的近端端面上；
    至少所述第一密封件(21)被紧密地夹持在所述底座(25)的远端端面和第一环形台阶(261)之间。
  36. [根据细则91更正 03.08.2021]　
    根据权利要求35所述的血管鞘装置，其特征在于，所述底座(25)的外周壁上设有径向凸出的至少一个卡接凸起(252)，所述外壳(26)上设有供所述卡接凸起(252)一一对应插接的卡孔(265)，所述底座(25)和所述外壳(26)之间通过所述卡接凸起(252)插接在所述卡孔(265)内而连接。
  37. [根据细则91更正 03.08.2021]　
    根据权利要求9所述的血管鞘装置，其特征在于，所述外壳(26)的侧壁上设有连接通道(262)；还包括三通阀门(263)，所述三通阀门(263)与所述连接通道(262)之间通过第一管路(264)连接。
  38. [根据细则91更正 03.08.2021]　
    一种血管鞘装置与预扩器的配合结构，其特征在于，包括
    权利要求9-37中任一项所述的血管鞘装置，其中扩张管(1)的远端上设有头部帽(14)；
    预扩器(3)，其包括预扩管(31)，及设在所述预扩管(31)的远端上的第二头部(32)，所述第二头部(32)上的至少部分的外径大于扩张管(1)的头部帽(14)的远端的内径，所述预扩管(31)及所述第二头部(32)适于在所述扩张管(1)内滑动，沿径向以撑开所述扩张管的头部帽(14)。
  39. [根据细则91更正 03.08.2021]　
    根据权利要求38所述的配合结构，其特征在于，所述第二头部(32)的外径大于所述扩张管(1)的头部帽(14)的内径。
  40. [根据细则91更正 03.08.2021]　
    根据权利要求39所述的配合结构，其特征在于，所述预扩管(31)的外径小于所述第二头部(32)的外径，且小于扩张管(1)处于径向未撑开时的内径。
  41. [根据细则91更正 03.08.2021]　
    根据权利要求38'40中任一项所述的配合结构，其特征在于，所述第二头部(32)上的所述至少部分上设有沿其轴向延伸的回流通道，所述回流通道的近端和远端均呈开口。
  42. [根据细则91更正 03.08.2021]　
    根据权利要求41所述的配合结构，其特征在于，所述回流通道为设在所述至少部分的外周壁上的径向向内凹陷的回流槽(321)。
  43. [根据细则91更正 03.08.2021]　
    根据权利要求41所述的配合结构，其特征在于，所述第二头部(32)包括呈圆锥环型的第一段(322)，所述第一段(322)的中部外径大于其两端的外径；所述回流通道至少设在所述第一段(322)的中部上；所述第一段(322)的近端与所述预扩管(31)的远端连接。
  44. [根据细则91更正 03.08.2021]　
    根据权利要求43所述的配合结构，其特征在于，所述第二头部(32)还包括成型在所述第一段(322)的近端上的第二段(323)，所述第一段(322)的近端通过所述第二段(323)的近端套接在所述预扩管(31)的远端外；所述第二段(323)的外径小于或等于所述第一段(322)的近端的外径。
  45. [根据细则91更正 03.08.2021]　
    一种预扩器，其特征在于，包括预扩管(31)，及设在所述预扩管(31)的远端上的第二头部(32)，所述第二头部(32)上的至少部分的外径大于扩张管(1)的头部帽的远端的内径，所述预扩管(31)及所述第二头部(32)适于在所述扩张管(1)内滑动，沿径向以撑开所述扩张管的头部帽(14)。
  46. [根据细则91更正 03.08.2021]　
    根据权利要求45所述的预扩器，其特征在于，所述第二头部(32)的外径大于所述扩张管(1)的头部帽(14)的内径。
  47. [根据细则91更正 03.08.2021]　
    根据权利要求46所述的预扩器，其特征在于，所述预扩管(31)的外径小于所述第二头部(32)的外径，且小于扩张管(1)处于径向未撑开时的内径。
  48. [根据细则91更正 03.08.2021]　
    根据权利要求45-47中任一项所述的预扩器，其特征在于，所述第二头部(32)上的所述至少部分上设有沿其轴向延伸的回流通道，所述回流通道的近端和远端均呈开口。
  49. [根据细则91更正 03.08.2021]　
    根据权利要求48所述的预扩器，其特征在于，所述回流通道为设在所述至少部分的外周壁上的径向向内凹陷的回流槽(321)。
  50. [根据细则91更正 03.08.2021]　
    根据权利要求48所述的预扩器，其特征在于，所述第二头部(32)包括呈圆锥环型的第一段(322)，所述第一段(322)的中部外径大于其两端的外径；所述回流通道至少设在所述第一段(322)的中部上；所述第一段(322)的近端与所述预扩管(31)的远端连接。
  51. [根据细则91更正 03.08.2021]　
    根据权利要求50所述的预扩器，其特征在于，所述第二头部(32)还包括成型在所述第一段(322)的近端上的第二段(323)，所述第一段(322)的近端通过所述第二段(323)的近端套接在所述预扩管(31)的远端外；所述第二段(323)的外径小于或等于所述第一段(322)的近端的外径。
PCT/CN2021/107025 2021-01-07 2021-07-19 扩张管、血管鞘装置、血管鞘装置与预扩器的配合结构、预扩器 WO2022147998A1 (zh)

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