CN112717269A

CN112717269A - Vascular sheath device, vascular sheath device and cooperation structure of expander in advance

Info

Publication number: CN112717269A
Application number: CN202110019033.0A
Authority: CN
Inventors: 陈晓; 刘冰冰; 林鹏; 黄韬; 张铭宇; 李阳; 王雪雪; 王银燕
Original assignee: Shanghai Hanling Medical Devices Co ltd
Current assignee: Shanghai Hanling Medical Devices Co ltd; Shanghai Kangdelai Enterprise Development Group Co Ltd
Priority date: 2021-01-07
Filing date: 2021-01-07
Publication date: 2021-04-30
Anticipated expiration: 2041-01-07
Also published as: CN112717269B

Abstract

The invention discloses a vascular sheath device, a matching structure of the vascular sheath device and a pre-dilator, wherein the vascular sheath device comprises a shell, a hemostatic valve and an expansion tube, the expansion tube comprises at least one deformation part, the deformation part is distributed in an S-direction bending manner towards a second end along a first end in the circumferential direction of the expansion tube, so that the deformation part is in an S-direction bending initial state when the deformation part is not subjected to the radial expansion force of the expansion tube; when the instrument sequentially passes through the hemostatic valve, the shell and the inner hole of the expansion tube, the outer peripheral wall of the instrument applies radial expansion force to the inner wall of the deformation part, and the inner hole of the expansion tube is radially expanded by the expansion force to increase the diameter of the inner hole of the expansion tube so as to adapt to the fact that surgical instruments with different sizes pass through the inner hole of the expansion tube; the expansion pipe has small outer diameter in the initial state and can be embedded into blood vessels with different sizes so as to effectively expand the blood vessels with different sizes and improve the adaptability of the blood vessel sheath.

Description

Vascular sheath device, vascular sheath device and cooperation structure of expander in advance

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a vascular sheath device, and a matching structure of the vascular sheath device and a pre-dilator.

Background

As an auxiliary guide instrument for arteriovenous interventional operation, the vascular sheath plays an important role in interventional therapy. The blood vessel sheath uses the puncture guide wire to guide the blood vessel sheath device to expand skin muscle tissue to enter the inner cavity of the epidermis blood vessel by the blood vessel puncture technology, and then the puncture guide wire is taken out, so that the far end of the blood vessel sheath device is arranged in the blood vessel, and a channel from the outside of the body to the inner cavity of the blood vessel is established for a surgical instrument to pass through. For example, prosthetic heart valve replacement procedures typically employ interventional valves that require a vascular sheath device to establish access when accessing the body through the femoral artery and vein.

For example, existing vascular sheath devices include a base, a hemostatic valve, a dilation tube, and a sheath; the hemostatic valve is hermetically arranged on the opening at the near end of the base, the sheath tube is arranged on the opening at the far end of the base, the expansion tube is arranged in the inner hole of the base and the inner hole of the sheath tube in a penetrating manner, the near end of the expansion tube is flared and is positioned outside the near end of the base, and the far end of the expansion tube extends out of the sheath tube. When the vascular sheath device is used for expanding blood vessels, the hard guide wire sequentially penetrates through the inner holes of the hemostatic valve and the expansion tube, and the distal end of the hard guide wire extends out of the distal end of the expansion tube so as to guide the whole vascular sheath device to move in the blood vessels after the blood vessels are moved in place; the expanding tube extends out of the sheath tube and moves in the blood vessel to apply radial expanding force to the blood vessel so as to expand the inner diameter of the blood vessel, and then surgical instruments enter the human body through the inner hole of the expanding tube to perform surgery on the pathological change position.

However, in the aforementioned sheath device, the diameter of the dilating tube is relatively fixed, and the dilating tube can only dilate a blood vessel corresponding to a disease singly. For example, transvascular sheath valve replacement devices typically have diameters between 6mm and 10mm, while the diameter of the human femoral artery and vein is typically about 4.5mm to 7.2 mm. The diameter of the expansion tube of the existing vascular sheath device is not small enough to be passed by valve instruments; or the size is too large, for example, the diameter of the expanding tube used in a large blood vessel is generally between 7mm and 11mm, when the expanding tube enters a femoral artery and a femoral vein, destructive axial friction is generated on the vessel wall, and vascular complications such as vessel tearing, calcified plaque falling and the like can be caused.

Therefore, the diameter of the dilating tube of the existing vascular sheath device is relatively fixed, so that the dilating tube cannot effectively dilate blood vessels with different diameters in an adaptive manner, and surgical instruments with different sizes can pass through the dilating tube, so that the defect of poor overall adaptability is overcome.

Disclosure of Invention

To solve the problems in the prior art, the present invention provides a vascular sheath device comprising

A housing;

a hemostasis valve sealingly disposed over the opening of the proximal end of the housing;

an expansion tube mounted on the distal opening of the housing;

the expansion pipe comprises at least one deformation part distributed along the circumferential direction of the expansion pipe, and the first end of the deformation part along the circumferential direction of the expansion pipe is bent and distributed towards the second end of the expansion pipe in an S-shaped direction so as to form a ring shape;

the deformation portion is radially expandable along the expansion pipe under the expansion force in the radial direction of the expansion pipe, and is in an expanded state.

Optionally, in the blood vessel sheath device, the dilating tube further includes at least one mounting portion, and a first end and a second end of the deforming portion are respectively connected to the adjacent deforming portion or mounting portion, so that all the deforming portions and the mounting portions enclose an annular shape.

Alternatively, in the aforementioned vascular sheath device, the deformation portions and the mounting portions are alternately distributed in the circumferential direction of the dilating tube.

Optionally, in the aforementioned vascular sheath device, the number of the deformation portions is at least two, and in two adjacent deformation portions along the circumferential direction of the dilating tube, the first end of the former deformation portion is connected with the second end of the latter deformation portion.

Optionally, in the vascular sheath device, the deformed portion includes, in a radial direction of the dilating tube, an inner layer section, at least one middle section and an outer layer section which are sequentially stacked from inside to outside; the inner layer section, the at least one middle section and the outer layer section are sequentially connected through the bent arc section to be bent in an S direction; or the deformation part comprises an inner layer section, at least one middle section and an outer layer section which are distributed in a laminated manner along the circumferential direction of the expansion pipe; the inner layer section, the at least one middle section and the outer layer section are connected in sequence through the bent arc sections, so that the deformation part is distributed along the circumferential direction of the expansion pipe in a S-shaped wavy line.

Optionally, in the vascular sheath device described above, the deformation portion is made of a deformable material; the deformation portion is switchable between an expanded state and an initial state; in the initial state, the expansion force is removed, and the deformation part contracts and resets along the radial direction of the expansion pipe.

Optionally, the vascular sheath device further comprises a flexible tube sleeved outside the expansion tube, and the expansion tube tends to maintain the initial state of radial contraction under the radial constraint force of the flexible tube.

Optionally, in the aforementioned vascular sheath device, at least a part of the mounting portion of the dilation tube is bonded to the flexible tube by glue.

Optionally, the blood vessel sheath device further comprises a head cap arranged on the distal end of the expansion tube; the head cap is provided with at least one first deformation joint and at least one connecting part arranged at the near end and/or the far end of the first deformation joint so as to connect the parts of the head cap at two sides of the first deformation joint;

the head cap is radially expanded along with the expansion of the deformation part through the first gap seam.

Optionally, in the vascular sheath device, the number of the connecting parts is at least two, and the length of the first deformation joint is not less than that of the connecting parts.

Optionally, in the blood vessel sheath device, one of the proximal end of the head cap and the distal end of the mounting portion of the dilation tube is provided with a clamping groove extending along the axial direction of the dilation tube, and the other one of the proximal end of the head cap and the distal end of the mounting portion of the dilation tube is provided with a clamping protrusion extending along the axial direction of the dilation tube, and the clamping protrusions are clamped in the clamping grooves in a one-to-one correspondence manner, so that the head cap is connected with the mounting portion.

Optionally, in the vascular sheath device described above, the head cap is fused with a platinum-iridium alloy material; or, still including the butt fusion in the development ring of the junction of block arch and draw-in groove, be equipped with on the development ring and correspond to the second movement joint of first movement joint.

Optionally, in the aforementioned blood vessel sheath device, the outer wall surface of the head cap is provided with at least one receiving groove for receiving glue, so that at least the head cap is adhesively connected to the inner wall of the flexible tube at the receiving groove; or a first bulge is formed between two adjacent clamping grooves on the head cap, a step surface is formed between the first bulge and the head cap, the far end of the hose is sleeved on the first bulge, the end face of the far end of the hose abuts against the step surface, and the hose and the first bulge are discontinuously bonded and fixed by glue.

Optionally, in the aforementioned vascular sheath device, the outer peripheral wall of the flexible tube is coated with a hydrophilic coating.

Optionally, in the aforementioned vascular sheath device, the dilating tube comprises a mounting section and a main body section integrally formed from the proximal end towards the distal end;

in an initial state without radial expansion force, the deformation part of the proximal end of the mounting section is in an expanded state, the deformation part of the main body section is in S-shaped bending distribution, and the mounting section is in a conical pipe with the outer diameter gradually reduced from the proximal end to the distal end of the mounting section so as to be formed on the proximal end of the main body section in a transition mode;

a fixation mechanism disposed on the proximal end of the dilation tube; the fixing mechanism comprises a fixing ring which is spliced with the mounting section, the fixing ring is sleeved outside the far end of the shell, and the near end of the hose is sleeved outside the fixing ring; and

a locking member fitted over the distal end of the housing and clamping the proximal ends of the retaining ring and hose between the locking member and the housing.

Optionally, in the vascular sheath device described above, the distal end of the fixing ring is a tapered portion that fits with the tapered tube, and the tapered portion is provided with a mounting groove that is suitable for the mounting portion on the mounting section to be embedded in one-to-one correspondence.

Optionally, in the aforementioned vascular sheath device, 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.

Optionally, in the aforementioned vascular sheath device, the locking member is screw-fitted on the distal end of the housing; and/or

At least part of the hose is connected with the mounting section and the fixing ring in an adhesive manner.

Optionally, in the aforementioned vascular sheath device, the distal end of the fixing ring is provided with at least one third deformation joint extending along the axial direction thereof.

Optionally, in the aforementioned vascular sheath device, the hemostatic valve comprises at least one first seal;

the first sealing element comprises a first annular base body, at least one sealing bulge which is formed on the far end of the first annular base body and protrudes towards the far end of the annular base body, and a first sealing channel is arranged on the end face of the sealing bulge;

the two side walls of the sealing bulge are slope surfaces, the slope surfaces incline from the far end of the sealing bulge to the root part of the near end of the sealing bulge, and the two side walls of the sealing bulge press the sealing bulge under the pressure of medium at the far end of the sealing bulge so as to force the first sealing channel to tend to be closed.

Optionally, in the aforementioned vascular sheath device, the slope surface includes a first inclined surface and a second inclined surface, a proximal end of the first inclined surface is connected to a distal end of the second inclined surface, a distal end of the first inclined surface is connected to the end surface of the sealing protrusion, a proximal end of the second inclined surface is formed on the first annular base, and an inclination angle of the first inclined surface with respect to the end surface of the sealing protrusion is different from an inclination angle of the second inclined surface with respect to the end surface of the sealing protrusion.

Optionally, in the aforementioned vascular sheath device, the first sealing channel is a straight seam, a cross seam, or a m seam.

Optionally, in the vascular sheath apparatus described above, the hemostatic valve further comprises a second sealing member disposed in a stacked relationship with the first sealing member;

the second sealing member comprises a second annular base body, a second bulge is formed in an inner hole of the second annular base body, the second bulge faces to the far end of the second annular base body and protrudes out, a second sealing channel is arranged on the second bulge, and the second sealing channel is communicated with the first sealing channel.

Optionally, in the vascular sheath device described above, the second sealing element further includes at least one first reinforcing rib, one end of the first reinforcing rib is fixed to an outer wall surface of a distal end of the second protrusion, and the other end of the first reinforcing rib is fixed to an inner wall surface of the second annular base body.

Optionally, in the vascular sheath device described above, the hemostatic valve further includes at least one sealing gasket stacked and interposed between the first sealing member and the second sealing member, a third sealing channel is disposed on the sealing gasket, and the third sealing channel, the first sealing channel, and the second sealing channel are distributed on the axis of the dilation tube.

Optionally, in the blood vessel sheath device, 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 is distributed on the periphery of the through hole and is communicated with the through hole;

and/or the distal end face and/or the proximal end face of the sealing gasket is provided with at least one second reinforcing rib.

Optionally, in the blood vessel sheath device, the third sealing channel includes a cross-shaped cutting groove formed in the distal end surface of the sealing gasket and an "X" cutting groove formed in the proximal end surface of the sealing gasket, or an "X" cutting groove formed in the distal end surface of the sealing gasket and an "X" cutting groove formed in the proximal end surface of the sealing gasket, and the cross-shaped cutting groove and the "X" cutting groove are formed together, so that the cutting groove is in a cross-shaped structure;

alternatively, the third sealed passage is the same as the second sealed passage.

Alternatively, the vascular sheath device described above,

the hemostatic valve comprises at least two sealing gaskets and a first support ring arranged between every two adjacent sealing gaskets; and/or

And the second support ring is arranged between the sealing gasket and the second sealing element.

Optionally, in the aforementioned vascular sheath device, the hemostatic valve further comprises a base;

a first annular step is arranged in an inner hole of the shell; the base is provided with an annular flange, the base is tightly embedded at the opening of the near end of the shell, and the annular flange is hooked on the end face of the near end of the shell;

the first seal is tightly clamped between the distal end face of the seat and the first annular step.

Optionally, in the vascular sheath device, the outer peripheral wall of the base is provided with at least one radially protruding clamping protrusion, the housing is provided with clamping holes for the clamping protrusions to be correspondingly inserted one by one, and the base and the housing are connected by inserting the clamping protrusions into the clamping holes.

Optionally, in the vascular sheath device described above, a connection channel is provided on a side wall of the housing; still include the three-way valve, the three-way valve with connect the passageway between through first pipeline connection.

Optionally, in the aforementioned vascular sheath device, 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; the inclined edges at the peripheries of the two sealing gaskets are respectively and tightly abutted with the inclined angle of the third inclined surface;

and/or a guide cylinder is further arranged at the far end of the second annular base body of the second sealing element, and the second bulge is positioned in the guide cylinder; the second support ring is sleeved outside the guide cylinder, the near end of the second support ring abuts against the far end face of the second annular base body, and a fourth inclined face which is in abutting fit with the inclined edge at the periphery of the sealing gasket is arranged on the far end face of the second support ring;

and/or a fifth inclined surface matched with the inclined edge at the periphery of the adjacent sealing gasket is arranged on the proximal end face of the first sealing element. Optionally, in the blood vessel sheath device, the inner wall surface of the distal end of the fixing ring is flared from the proximal end to the distal end.

Optionally, in the vascular sheath device, the sealing protrusion includes four branch bosses, the branch bosses form a cross protrusion, two side walls of each branch boss are respectively a slope, and the first sealing channel on the end surface of the cross protrusion forms a cross slit.

The invention also provides a matching structure of the vascular sheath device and the pre-dilator, which comprises

The vascular sheath device of any of the above;

a pre-expander comprising a pre-expander tube having an outer diameter greater than an inner diameter of the expander tube in an initial state.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic structural view of a vascular sheath device provided in example 1 of the present invention;

FIG. 2 is an exploded view of the hose, the dilation tube and the first embodiment of the headgear of FIG. 1;

FIG. 3 is an exploded view of the distal end of the dilation tube of FIG. 2 and the first embodiment headgear;

FIG. 4 is a schematic longitudinal cross-sectional view of the dilation tube of the vascular sheath apparatus of FIG. 1;

FIG. 5a is a schematic cross-sectional view of the sheath and hemostatic valve of the vascular sheath device of FIG. 1;

FIG. 5b is a schematic cross-sectional view of the sheath device of FIG. 5a in another orientation with the hemostatic valve;

FIG. 5c is an enlarged partial schematic view of a cross-section of the sheath and hemostatic valve of the vascular sheath device of FIG. 5 a;

FIG. 6 is an exploded view of the hemostatic valve of the vascular sheath device of FIG. 1;

FIG. 7 is a schematic view of the first seal of FIG. 6;

FIG. 8 is a schematic view of the second seal of FIG. 6;

FIG. 9a is a schematic diagram of the gasket of FIG. 6;

FIG. 9b is a schematic structural view of another embodiment of the gasket of FIG. 6;

FIG. 10 is a schematic structural view of the base of FIG. 6;

FIG. 11 is an exploded view of the distal end of the housing and the lock nut, securing ring of one embodiment;

FIG. 12 is an exploded view of the first and second support rings of FIG. 6;

FIG. 13 is a schematic structural view of a pre-expander in a mated configuration provided in example 3 of the present invention;

FIG. 14 is a schematic structural view of a second head of the pre-dilator of FIG. 13;

FIG. 15a is an exploded view of the flexible tube, the dilation tube, the visualization ring, and the second embodiment of the head cap of the vascular sheath apparatus of FIG. 1;

FIG. 15b is a schematic structural view of the head cap of FIG. 15 a;

FIG. 16a is another embodiment of a retaining ring of the vascular sheath apparatus of FIG. 1;

FIG. 16b is an enlarged partial schematic view of the distal end of the retaining ring of FIG. 16 a;

FIG. 17a is a schematic structural view of the dilation tube;

FIG. 17b is a schematic view in partial longitudinal section of the dilation tube of FIG. 17 a;

description of reference numerals:

1-expanding the tube; 11-a deformation; 111-a first end; 112-a second end; 11 a-inner layer section; 11 b-middle section; 11 c-outer layer segment; 11 d-arc section; 12-a mounting portion; 121-a third end; 122-a fourth end; 13-a hose; 14-a head cap; 141-a first deformation joint; 142-a receiving groove; 151-card slot; 152-a snap-fit projection; 16-a mounting section; 161-an extension; 17-a body section;

2-a hemostatic valve; 21-a first seal; 211 — a first sealed channel; 212-a first annular base; 213-sealing protrusion; 2131-a first inclined surface; 2132-a second inclined surface;

22-a second seal; 221-a second sealed channel; 222-a second annular substrate; 223-a second projection; 224-a guide cylinder; 225-a first stiffener;

23-a gasket; 231-a third sealed channel; 232-beveled edge; 233-a second reinforcing rib; 234-cutting groove;

241-a first support ring; 2411-a third inclined surface; 242-a second support ring; 2421-fourth inclined surface; 25-a base; 251-an annular flange; 252-a snap-fit projection; 253-a guide head; 26-a housing; 261-a first annular step; 262-connecting channel; 263-three-way valve; 264-first conduit; 265-card hole; 27-a locking member; 28-a fixed ring; 282-an installation groove; 283-a flared part; 281-a cone; 2811-third deformation joint;

3-pre-expander; 31-pre-expanding the pipe; 32-a second head; 321-a reflux tank;

4-a developing ring; 41-second deformation joint.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Example 1

The present invention provides a vascular sheath device, as shown in fig. 1 to 14, comprising a housing 26, a hemostatic valve 2 and a dilation tube 1. Wherein the hemostatic valve 2 is sealingly disposed over the opening at the proximal end of the housing 26; the proximal end of the dilation tube 1 fits over the distal opening of the housing 26.

For example, as shown in fig. 5a, 5b and 11, the outer wall surface of the distal opening of the outer shell 26 has an external thread, the proximal opening of the dilation tube 1 is fixed with a fixing ring 28, the distal end of the outer shell 26 is connected with a locking member 27 by a thread, the proximal end of the fixing ring 28 is a flared structure, and the flared end of the flared structure is sleeved on the distal end of the outer shell 26 and clamped between the locking member 27 and the distal end of the outer shell 26, so as to achieve connection between the dilation tube 1 and the distal end of the outer shell 26.

As shown in fig. 4, the expansion pipe 1 includes at least one deformation portion 11 distributed along the circumferential direction thereof, and a first end 111 of the deformation portion 11 along the circumferential direction of the expansion pipe 1 is bent and distributed in an S-shaped direction toward a second end 112 to form a ring shape; the deformable portion 11 is expandable in the radial direction of the expandable tube 1 by an expansion force in the radial direction of the expandable tube 1, and is in an expanded state.

According to the expansion pipe 1 with the structure, the first end 111 of the deformation part 11 along the circumferential direction of the expansion pipe 1 is distributed in an S-direction bending manner towards the second end 112 of the deformation part, so that when the deformation part 11 is not subjected to the radial expansion force of the expansion pipe 1, the deformation part 11 is in an initial state of S-direction bending, and the diameter of the inner hole of the expansion pipe 1 is the minimum; when the surgical instrument is inserted into the inner hole of the expansion tube 1, and the outer diameter of the surgical instrument is larger than the diameter of the inner hole of the expansion tube 1, the outer peripheral wall of the surgical instrument applies a radial expansion force to the inner wall of the deformation part 11, and the first end 111 and the second end 112 of the deformation part 11 are continuously spread towards the directions away from each other along the outer peripheral wall of the surgical instrument by the expansion force, so that the inner hole of the expansion tube 1 is radially expanded, the diameter of the inner hole of the expansion tube 1 is increased, and the surgical instrument with different sizes can be adapted to penetrate through the inner hole of the expansion tube 1; meanwhile, the outer diameter of the expansion pipe 1 is small in the initial state, and the expansion pipe can be embedded into blood vessels with different sizes so as to effectively expand the blood vessels with different sizes and improve the use adaptability of the expansion pipe 1.

Specifically, the expanding tube 1 further comprises at least one mounting portion 12. For example, as shown in fig. 4, the mounting portions 12 and the deformation portions 11 are distributed in three, the mounting portions 12 and the deformation portions 11 are alternately distributed along the circumferential direction of the expanding tube 1, and the first ends 111 and the second ends 112 of the deformation portions 11 are respectively connected to the mounting portions 12 adjacent thereto to form an annular tube.

For example, the two ends of the mounting portion 12 along the circumferential direction of the extension tube 1 are respectively a third end 121 and a fourth end 122, the first end 111 of the deformation portion 11 is connected with the fourth end 122 of the previous mounting portion 12, and the second end 112 of the deformation portion 11 is connected with the third end 121 of the next mounting portion 12 to form a ring-shaped tube. The deformation part 11 in the expansion pipe 1 plays a role of radial deformation, and the mounting part 12 plays a role of mounting and positioning the deformation part 11; the deformation portions 11 and the mounting portions 12 are alternately distributed, so that the deformation amount of the deformation portions 11 in the radial direction is more uniform when the deformation portions are deformed.

Preferably, in the initial state, the inner peripheral walls of all the deformation portions 11 and the inner peripheral wall of the mounting portion 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 smoothly extends into the inner hole of the dilation tube 1 along the circumferential surface, and the surgical instrument can abut against the whole inner circumferential surface along the circumferential direction, so as to apply a radial expansion force to the deformation portions 11, and further, the deformation portions 11 are radially expanded; the peripheral walls of all the deformation parts 11 and the peripheral wall of the mounting part 12 are positioned on the same circumferential surface, and the peripheral walls are positioned on the same circumference, so that the expansion pipe 1 is inserted into a blood vessel, and when the expansion pipe moves in the blood vessel, the peripheral arc surface of the expansion pipe 1 is contacted with the inner wall of the blood vessel, thereby preventing the inner wall of the blood vessel from being scratched.

The number of the deformation portions 11 and the mounting portions 12 is not limited, and for example, there may be one deformation portion 11 and one mounting portion 12; or the number of the deformation parts 11 is one, and the number of the mounting parts 12 is two, or the number of the deformation parts 11 and the number of the mounting parts 12 can be other, the number of the deformation parts 11 can be the same as or different from the number of the mounting parts 12, and the specific number of the deformation parts can be determined according to the requirement.

The deformation portions 11 and the mounting portions 12 may not be alternately arranged in the circumferential direction of the extension tube 1. For example, the first end 111 of the partially deformed portion 11 is adjacent to the mounting portion 12, the second end 112 is adjacent to the other deformed portion 11, and the first end 111 of the former deformed portion 11 is connected to the second end 112 of the latter deformed portion 11 in the two adjacent deformed portions 11, so that the two adjacent deformed portions 11 are deformed more easily by a larger amount when the deformed portions 11 receive the expansion force in the radial direction of the expandable tubular member 1.

As for the structure of the deformed portion 11, as shown in fig. 4, the deformed portion 11 includes an inner layer section 11a, at least one intermediate section 11b, and an outer layer section 11c, which are sequentially stacked from inside to outside in the radial direction of the stent 1; the inner layer section 11a, the at least one middle section 11b and the outer layer section 11c are sequentially connected through the bent arc section 11d to be bent in the S direction.

For example, as shown in fig. 4, when the intermediate section 11b is one, the inner section 11a, the intermediate section 11b and the outer section 11c are stacked in the radial direction of the stent 1, and the free end of the inner section 11a serves as the first end 111 and the free end of the outer section 11c serves as the second end 112. When the surgical instrument is inserted into the inner hole of the deformation portion 11, the surgical instrument applies a radial expansion force to the inner hole of the deformation portion 11, and under the expansion force, the first end 111 of the inner layer section 11a and the second end 112 of the inner layer section 11a stretch and spread towards the two ends along the circumferential direction of the expansion pipe 1, so that the inner hole of the expansion pipe 1 is expanded, and the diameter of the inner hole of the expansion pipe 1 is increased, so that the surgical instrument can pass through the inner hole. The maximum deformation of the deformation portion 11 is to stretch the inner layer segment 11a and the outer layer segment 11c apart, and not to be layered on both sides of the middle segment 11b, so that the inner bore diameter of the stent 1 is maximized.

As for the intermediate sections 11b, the number of the intermediate sections 11b may also be two, three, four, and so on, two adjacent intermediate sections 11b are connected by bending the circular arc sections 11d, and in an initial state, the plurality of intermediate sections 11b are stacked and distributed, the inner section 11a is stacked on the inner side of the intermediate section 11b at the innermost layer, and the outer section 11c is stacked on the outer side of the intermediate section 11b at the outermost layer. In this embodiment, the plurality of intermediate sections 11b, the inner section 11a, and the outer section 11c are stacked in the radial direction of the dilating tube 1, so that the diameter of the inner hole of the dilating tube 1 can be set smaller, and the inner hole does not protrude to occupy the radial thickness space of the dilating tube 1, thereby enlarging the deformation range of the inner hole of the dilating tube 1, and being capable of adapting to the dilation of blood vessels with different diameters in a larger range and passing surgical instruments with different sizes in a larger range.

As a modification, the inner layer segments 11a, the plurality of intermediate segments 11b, and the outer layer segments 11c may be layered in the radial direction of the expandable tubular body 1 or may be layered in the circumferential direction of the expandable tubular body 1, and in this case, the entire deformable portion 11 may be arranged in a wavy line extending in the S-direction in the circumferential direction of the expandable tubular body 1, and when the deformable portion 11 receives an expansion force, the inner hole of the deformable portion 11 is expanded, thereby achieving the above-described function.

The deformation part 11 can be made of polymer plastics, and correspondingly, the expansion pipe 1 can be switched from an initial state to an expansion state; in use, the stent can also be retracted under the action of the blood vessel wall and used as a disposable stent 1.

In order to make the expanding tube 1 reusable, it is preferable that the deformation portion 11 is made of a deformable material; the deformation portion 11 is switchable between an expanded state and an initial state; in the initial state, the expansion force is released, and the deformed portion 11 is contracted and restored in the radial direction of the expansion tube 1.

For example, in fig. 4, after the surgical instrument passes through or exits the dilation tube 1, the dilation force on the dilation tube 1 is removed, and the dilation tube 1 is reset to the initial state by the self-deforming material, and the active deformation reset is performed, that is, the first end 111 and the second end 112 are retracted along the circumference of the dilation tube 1, so that the inner layer section 11a, the middle section 11b and the outer layer section 11c are arranged in a stacked manner and in an S-shaped configuration.

For example, the shape-memory material is used as the deformation material, and when the radial expansion force of the device on the dilation tube 1 is removed, the shape-memory material can maintain the distribution of the S-direction of the inner layer segment 11a, the middle segment 11b and the outer layer segment 11 c. Preferably, the shape memory material is a shape memory alloy material, and the S-direction is maintained after the deformation portion 11 is formed. The deformable material may also be other elastic materials that are known in the art.

As shown in figure 2, in order to avoid the scoring effect of the bent section of the deformation part 11 on the blood vessel after the expansion of the expansion tube 1, as shown in figure 1, the blood vessel sheath further comprises a deformable hose 13 which is sleeved outside the expansion tube 1, and the expansion tube 1 tends to keep the initial state of radial contraction under the radial constraint force of the hose 13, namely the expansion tube 1 is in passive deformation retraction.

For example, the hose 13 is a polymer hose having a shrinking and expanding function, such as a silicone tube, a latex tube, a PU tube, and the like. The hose has good elasticity, when the instrument passes through the expansion pipe 1, the hose 13 is also expanded after the expansion pipe 1 is expanded, the expansion pipe 1 can be wrapped, and the smooth outer surface of the hose is in contact with the wall of a blood vessel to protect the blood vessel; when the instrument is withdrawn from the expansion tube 1, the flexible tube 13 automatically retracts to apply radial constraint force to the expansion tube 1, so that the expansion tube 1 is radially contracted and reset.

Preferably, part of the outer wall surface of the hose 13 is adhered to the mounting portion 12 by glue, but not adhered to the outer wall surface of the deformation portion 11, so that when the deformation portion 11 is deformed, the hose 13 has corresponding deformability to adapt to the deformation of the deformation portion 11. The hose 13 and the mounting part 12 are bonded by glue, so that the hose 13 is prevented from generating wrinkles due to friction to affect the function of the hose when in use, wherein the glue can be bonded in a linear uninterrupted mode, a linear interrupted mode (namely a dotted line mode), a spiral mode around an axis, a ring mode which is not parallel to the axis and the like.

Further, in order to make the hose 13 move in the blood vessel, the friction force to the blood vessel wall is small, and the outer peripheral wall of the hose 13 is coated with the hydrophilic coating, so that the friction force between the outer wall of the hose 13 and the blood vessel wall is reduced, the lubricating effect is achieved, the friction of the hose 13 to the blood vessel wall is reduced, and the blood vessel is further protected.

The vascular sheath device further comprises a head cap 14 provided at the distal end of the dilation tube 1; in fig. 2 and 3, a first embodiment of head cap 14 is illustrated, head cap 14 being provided with at least one first deformation joint 141, and at least one connection provided at the proximal and/or distal end of first deformation joint 141, to connect the portions of head cap 14 on either side of first deformation joint 141; the head cap 14 is radially expanded by the first deformation joint 141 along 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 joints 141 are circumferentially distributed on the head cap 14 at intervals along the expansion tube 1, for example, three first deformation joints 141 are uniformly distributed on the head cap 14, and the head cap 14 is circumferentially divided into three parts, namely a first part, a second part and a third part, for example, a connecting part is arranged at the far end (and/or the near end) in each first deformation joint 141 to connect two adjacent parts on the head cap. The number of the first deformation joints 141 may be other, such as one, two, four, five, six, etc., and the specific number is not limited. The first deformation joint 141 is provided to ensure that the sheath of the blood vessel can ensure the shape of the head cap 14 before being expanded, so as to be inserted into the blood vessel and move in the blood vessel, the expansion tube 1 can slide in place in the blood vessel to establish a required passage, and when a surgical instrument passes through the first deformation joint 141, the head cap 14 can be deformed in the radial direction, so that the head cap 14 can be easily torn off without blocking the passing of the instrument.

A plurality of coupling parts may be provided to couple portions of the head cap 14 on both sides of the first deformation joint 141.

As shown in fig. 3, the length of the first deformation joint 141 is not less than the length of the connecting portion in the axial direction of the extension tube 1, so that the head cap 14 has a large deformation space and is more easily torn when a surgical instrument passes through.

For example, the shape of the first deformation joint 141 is linear, L-shaped, S-shaped, Z-shaped, or other shapes, and the shape is not limited specifically and is selected according to the requirement.

There are various ways of connecting the head cap 14 to the distal end of the dilation tube 1, for example, as shown in fig. 3, one of the proximal end of the head cap 14 and the distal end of the mounting portion 12 of the dilation tube 1 is provided with a clamping groove 151 extending along the axial direction of the dilation tube 1, and the other is provided with a clamping protrusion 152 extending along the axial direction of the dilation tube 1, and the clamping protrusions 152 are clamped in the clamping groove 151 in a one-to-one correspondence manner, so that the mounting portion 12 is connected to the head cap 14.

For example, the proximal end of the head cap 14 is provided with a locking groove 151, and the distal end of the mounting portion 12 of the extension tube 1 is provided with a locking protrusion 152, or the positions of the locking groove 151 and the locking protrusion 152 may be reversed, and the distal end of the mounting portion 12 of the extension tube 1 is connected to the head cap 14 through the locking relationship between the locking protrusion 152 and the locking groove 151. In addition to the insertion fit between the locking groove 151 and the engaging protrusion 152, the head cap 14 and the distal end of the mounting portion 12 may also be welded or adhered to the locking groove 151 and the engaging protrusion 152, or spot welded or welded, or other conventional fixing methods, or both of these fixing methods may be used.

Preferably, a platinum-iridium alloy material is fused on the head cap 14 to achieve a developing effect, so that the position of the dilation tube 1 in a human body can be easily captured in a blood vessel. In addition, as shown in fig. 3, the distal end of the head cap 14 is rounded to make it more smooth when entering and exiting a blood vessel, and to minimize damage to the blood vessel.

As shown in fig. 3, a first protrusion is formed between two adjacent clamping grooves 151, a step surface is formed between the first protrusion and the head cap 14, the distal end of the flexible tube 13 is sleeved on the first protrusion, the distal end surface of the flexible tube 13 abuts against the step surface, and the flexible tube 13 and the first protrusion are discontinuously bonded and fixed by glue, so that the first deformation joint 141 of the head cap 14 and the flexible tube 13 have a deformable amount when being expanded.

For example, the distal end of the flexible tube 13 is bonded to the first protrusion of the head cap 14 by glue to form a connection point, wherein the connection point is not limited to a full bond, but also includes a partial bond, i.e., a bond on portions of the head cap on either side of the deformation joint 141, the presence of the deformation joint 141 ensuring a sufficient amount of deformation of the flexible tube 13 upon radial expansion.

A second embodiment of the head cap 14, shown in fig. 15a and 15b, differs from the head cap 14 shown in fig. 3 in the structure: at least one receiving groove 142 is provided on an outer wall surface of the head cap 14 for receiving glue to make the head cap 14 bonded to the hose 13 more accurate. For example, the receiving groove may be a plurality of receiving grooves, such as two, three, four, five, etc., and the plurality of receiving grooves may be spaced apart along the circumference of the head cap 14, such that the distal end of the hose 13 forms a spaced apart partial bond with the glue in the receiving grooves to prevent the hose 13 from being torn when expanded.

As shown in fig. 15a, the developing ring 4 is welded to a connection portion of the engaging protrusion 152 and the engaging groove 151, and the developing ring 4 is provided with a second deformation joint 41 corresponding to the first deformation joint 141, so that when a surgical instrument passes through the engaging protrusion 152 and the engaging groove 151, the developing ring 4 also has a deformation amount of radial expansion.

For example, after the engaging protrusion 152 and the engaging groove 151 are engaged, the developing ring 4 is sleeved outside the engaging protrusion and the engaging groove, and the engaging protrusion 152, the engaging groove 151 and the developing ring 4 are welded together,

as shown in fig. 17a and 17b, the dilation tube 1 comprises a mounting section 16 and a main body section 17 integrally formed from a proximal end towards a distal end; under the initial state without radial expansion force, the deformation part 11 at the near end of the mounting section 16 is in an expanded state, the deformation part 11 of the main body section 17 is in S-shaped bending distribution, and the mounting section 16 is in a conical pipe (in a horn-shaped structure) with the outer diameter gradually reduced from the near end to the far end so as to be formed on the near end of the main body section 17 in a transition mode; the proximal end of the dilation tube 1 is connected to the distal end of the housing 26 by a mounting section 16; the hose 13 is sleeved outside the proximal end of the dilating tube 1. For example, the mounting section 16 may be shaped to form the tapered tube described above.

Because the expansion degree of the deformation part 11 of the installation section 16 of the expansion tube 1 is gradually reduced from the proximal end to the distal end, the proximal end of the installation section 16 is connected with other components, the other components are not deformed along with the radial expansion or reduction of the deformation part 11, and meanwhile, the deformation part 11 of the main body section 17 is ensured to keep a furled state and the outer diameter of the main body section 17 is small when the radial expansion force is not applied, so that the main body section 17 can conveniently enter into the blood vessel, namely, the installation section 16 plays a transition role in connecting other components with the main body section 17, and the radial expansion or furled deformation process of the main body section 17 cannot be influenced.

As shown in fig. 5a and 5b, the vascular sheath device further comprises a fixing mechanism provided on the proximal end of the dilation tube 1; the fixing mechanism comprises a fixing ring 28 which is in plug fit with the mounting section 16, the fixing ring 28 is sleeved outside the distal end of the shell 26, and the proximal end of the hose 13 is sleeved outside the fixing ring 28; and a locking member 27, the locking member 27 being fitted out of the distal end of the housing 26, and clamping the fixing ring 28 and the proximal end of the hose 13 between the locking member 27 and the housing 26 to achieve connection between the proximal end of the mounting section 16 and the distal end of the housing 26.

Preferably, locking member 27 is a nut that is threadably engaged on the distal end of housing 26 to clamp and lock the proximal ends of mounting segment 16, retaining ring 28 and hose 13 to the distal end of housing 26. Alternatively, the locking member 27 may have other configurations, such as bolts or screws, or a flange.

Further, the proximal end of the fixing ring 28 extends out of the proximal end of the mounting section 16, the proximal end of the flexible tube 13 is sleeved outside the proximal ends of the mounting section 16 and the fixing ring 28, and the inner wall of the proximal end of the flexible tube 13 can be adhered to the outer wall surfaces of the mounting section 16 and the fixing ring 28 by glue, so that the tightness of the connection between the flexible tube 13 and the fixing ring 28 and the mounting section 16 is enhanced. The proximal inner wall of the flexible tube 13 may be bonded to the outer wall of the corresponding mounting segment 16 and retaining ring 28, or may be partially bonded to the outer wall of the mounting segment 16 and retaining ring 28.

The fitting manner between the mounting segment 16 and the fixing ring 28 may be an adhesive manner or other fixing manner, fig. 11 illustrates a first embodiment of the fixing ring 28, fig. 16a illustrates a second embodiment of the fixing ring 28, and the fixing ring 28 in fig. 11 is taken as an example to explain.

As shown in fig. 11 and 17a, the mounting section 16 is formed by molding the proximal end of the dilation tube 1, and the fixing ring 28 is provided with mounting slots 282 into which the mounting portions 12 of the mounting section 16 are inserted in one-to-one correspondence, and the mounting portions 12 of the mounting section 16 are inserted into the mounting slots 282 in one-to-one correspondence, so as to achieve the matching between the mounting section 16 and the fixing ring 28.

Preferably, the proximal end of the fixing ring 28 presents a flared portion 283 expanding towards the proximal end of the housing 26, the flared portion 283 being clamped between said housing 26 and the locking member 27, facilitating the clamping of the fixing ring 28 between the housing 26 and the locking member 27. Further, the expanding tube 1 is made of polymer plastic, and then the fixing ring 28 and the mounting section 16 are bonded and fixed by polymer adhesive, so that the fixing ring 28 and the mounting section 16 are perfectly attached to each other, and the connection tightness is guaranteed.

The structure of the retaining ring 28 shown in fig. 16a differs from the retaining ring 28 shown in fig. 11 in that: the distal end of the fixing ring 28 presents a tapered portion 281 cooperating with the tapered tube; the conical part 281 is provided with mounting grooves 282 suitable for the mounting parts 12 on the mounting section 16 to be correspondingly embedded one by one; the distal end of the tapered portion 281 is close to the proximal end of the main body section 17, so that the contact area between the fixing ring 28 and the mounting section 16 is increased, the supporting force for the dilation tube 1 is increased, the dilation tube 1 cannot be deformed in use to affect the operation, the fixing ring 28 and the dilation tube 1 are connected more firmly, the supporting force for the dilation tube 1 is enhanced in the instrument withdrawal process in use, and the dilation tube 1 cannot be bent due to large resistance.

Preferably, the distal end of the fixing ring 28 is provided with at least one third deformation joint 2811 extending along the axial direction thereof, so as to ensure that the fixing ring 28 can have a deformation amount in the radial direction and can automatically retract so as to adapt to the radial increasing or automatic retracting process of the deformation portion 11.

Further, as shown in fig. 16b, the inner wall surface of the distal end of the fixing ring 28 is flared from the proximal end toward the distal end, for example, by thinning the thickness of the fixing ring 28 at different positions of the distal end to form a flare, so that the flare is configured not to jam the instrument when the instrument is withdrawn from the dilation tube 1 after passing through the fixing ring 28 into the dilation tube 1.

As shown in fig. 5, 6, and 7, 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 a distal end of the first annular base 212 and protruding toward the distal end of the first annular base 212, a first sealing passage 211 provided on an end surface of the sealing protrusion 213; the two side walls of the sealing protrusion 213 are sloped, the slopes are inclined from the distal end of the sealing protrusion 213 to the root of the proximal end thereof, and the two side walls of the sealing protrusion 213 are pressed against the sealing protrusion 213 by the pressure of the medium at the distal end thereof, so as to force the first sealing channel 211 to close.

That is, when the medium at the distal end of the sealing protrusion 213 applies medium pressure to the two side walls of the sealing protrusion 213, the two side walls of the sealing protrusion 213 are pressed together, so that the first sealing channel 211 tends to be closed, thereby stopping bleeding.

For example, as shown in fig. 5, the sealing protrusion 213 includes four branch bosses, the branch bosses form a cross-shaped protrusion, two side walls of each branch boss respectively form a slope, and the first sealing channel 211 on the end surface of the cross-shaped protrusion forms a cross-shaped slit.

In fig. 7, each slope is inclined downward from the end face of the corresponding branch boss toward the root thereof, when blood or solution is on the slope in fig. 7, the blood or solution applies a pressure to the slope along the inclination angle of the slope, the pressure has a uniform component in the radial direction and the axial direction of the first annular base 212, the radial component forces the slope to press the branch bosses, the slopes on both sides of each branch boss press the corresponding branch bosses toward the slits, so that the cross slits tend to seal or close, the blood is stopped at the distal side of the sealing protrusion 213, and does not flow out of the human body through the hemostatic valve 2. At the same time, the cross-slit also facilitates ensuring that subsequent instruments are easier to pass through the first seal 21.

As shown in fig. 7, it is preferable that the slope surface includes a first inclined surface 2131 and a second inclined surface 2132, a proximal end of the first inclined surface 2131 is connected to a distal end of the second inclined surface 2132, a distal end of the first inclined surface 2131 is connected to an end surface of the seal protrusion 213, a proximal end of the second inclined surface 2132 is formed on the first annular base 212, and an inclination angle of the first inclined surface 2131 with respect to the end surface of the seal protrusion 213 is different from an inclination angle of the second inclined surface 2132 with respect to the end surface of the seal protrusion.

For example, the inclination angle of the first inclined surface 2131 is larger than the inclination angle of the second inclined surface 2132, so that the radial component of the blood pressure applied to the first inclined surface 2131 is larger than the radial component of the blood pressure applied to the second inclined surface 2132, and the first inclined surface 2131 presses the branch bosses more intensively, thereby further ensuring the sealing performance of the seal projection 213. As a modification, the inclination angle of the first inclined surface 2131 is smaller than the inclination angle of the second inclined surface 2132.

Of course, as a modification, the cross slit may be replaced with a circular through hole, or a through hole of another shape, as long as the axis of the first seal passage 211 coincides with the axis of the extension pipe 1. The sealing protrusion 213 may be a linear protrusion, a cross protrusion, or other protrusions, and only the two side walls of each branch boss of the sealing protrusion 213 are required to form the slope.

The second seal member 22 has a structure similar to that of the first seal member 21, and as shown in fig. 8, the second seal member 22 includes a second annular base 222, a second projection 223 formed in an inner hole of the second annular base 222, the second projection 223 projecting toward a distal end of the second annular base 222, a second seal passage 221 provided on the second projection 223, the second seal passage 221 communicating coaxially with the first seal passage 211.

For example, as shown in fig. 8, the second protrusion 223 has a bowl or ball shape, and the second sealing channel 221 is disposed at the center of the second protrusion 223.

For example, the second sealing passage 221 is a cross slit, or a through hole. The second sealing element 22 is stacked on the proximal side of the first sealing element 21 to form a second seal to assist the first sealing element 21 in further sealing.

Preferably, the second sealing member 22 further includes at least one first rib 225, as shown in fig. 8, four first ribs 225 are provided, the four first ribs 225 are uniformly distributed, one end of each first rib 225 is fixed to the outer wall surface of the distal end of the second protrusion 223, and the other end is fixed to the inner wall surface of the second annular base 222, so as to increase the strength of the second protrusion 223. Of course, the number of the first reinforcing ribs 225 may be other, such as one, two, three, five, etc., and the specific number may be selected according to the requirement.

As shown in fig. 6 and 9a, the hemostatic valve 2 further includes a sealing gasket 23 stacked and sandwiched between the first sealing member 21 and the second sealing member 22, a third sealing channel 231 is disposed on the sealing gasket 23, and the third sealing channel 231, the first sealing channel 211 and the second sealing channel 221 are distributed on the axis of the extension tube 1 to form a plurality of 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 seal member is in close contact with the wall surface of the inner hole of the housing 26 to form a sealing connection with the wall surface of the inner hole of the housing.

Preferably, as shown in fig. 9a, the sealing gasket 23 is a circular plate, and a third sealing channel 231 is provided at the center of the sealing gasket 23, and the third sealing channel 231 may be a through hole and/or a slit to further enhance the sealing effect. Preferably, sealed 23, first sealing member 21, the second sealing member 22 of filling up all adopt rubber materials to make, and the third sealed passageway 231 of sealed 23 of filling up is the through-hole, and the diameter of through-hole is less than the external diameter of seal wire, can play sealed effect when the seal wire passes through, and the sealed 23 of softer silica gel material has fine elasticity, makes the diameter of round hole expand to in bigger scope, supplies major diameter's apparatus to pass through.

Preferably, as shown in fig. 9b, the third sealing channel 231 includes a cross-shaped cutting groove formed in the distal end surface of the sealing pad 23 and an "X" cutting groove formed in the proximal end surface of the sealing pad 23, or an "X" cutting groove formed in the distal end surface of the sealing pad 23 and a cross-shaped cutting groove formed in the proximal end surface of the sealing pad 23, and the cross-shaped cutting groove and the "X" cutting groove are formed together, so that the cutting groove is in a cross-shaped structure.

When the surgical instrument passes through the through hole of the third sealing channel 231, under the action of the radial stretching force of the surgical instrument, the sealing gasket is easily deformed and stretched radially from the position of the cutting groove, so that the contact area between the surgical instrument and the second sealing element 22 is reduced, the original surface-surface contact is changed into surface-to-line or point contact, and the friction force of the surgical instrument passing through the third sealing element is reduced, so that the surgical instrument can pass through the through hole.

The cutting groove 234 may be a straight cutting groove 234 or a cutting groove 234 having another shape, which is specifically selected according to the requirement, and is not limited to the above-mentioned square shape, but may also be a cross cutting groove. Alternatively, the cutting groove 234 may be provided only on the distal end face or the proximal end face of the seal gasket 23. When the cutting grooves 234 are plural, part of the cutting grooves 234 are distributed on the proximal end face of the seal gasket 23, and part of the cutting grooves 234 are distributed on the distal end face of the seal gasket 23; preferably, the plurality of cutting grooves 234 on the same end face are evenly distributed around the periphery of the channel.

As a variation, the third sealing channel 231 may also be a slit like the first sealing channel 211 or the second sealing channel 221 described above.

Further, a plurality of second reinforcing ribs 233 are provided on the distal end surface of the gasket 23 to enhance the supporting force of the second sealing member 22 and the gasket 23. The first seal member 21, the gasket, and the second seal member 22 are stacked from the distal end toward the proximal end.

As for the base 25, as shown in fig. 5, 6 and 10, a radially protruding annular flange 251 is provided on the proximal end surface of the base 25, 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 clamping protrusions 252 radially protrude from the outer peripheral wall of the base 25 at intervals; correspondingly, the shell 26 is provided with a clamping hole 265 for the clamping protrusion 252 to be inserted, and the clamping protrusion 252 is inserted in the clamping hole, so that the base 25 and the shell 26 are assembled, and the whole hemostatic valve 2 is hermetically connected without adding any adhesive on the base 25 and the shell 26. The base 25 is provided with a guide channel, 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 seat 25 abuts on the proximal end face of the second annular base 222 of the second seal 22; as shown in fig. 5a and fig. 2, a first annular step 261 is provided on the inner wall surface of the housing 26, and the distal end surface of the first sealing member 21 abuts against the first annular step 261, so that the first sealing member 21, the second sealing member 22, and the gasket 23 are fitted to the housing 26 and the base 25.

Alternatively, as shown in FIG. 10, the distal end surface of the base 25 is provided with a conical guide head 253 which extends into the inner bore of the second annular base 222 of the second seal member 22, in order to guide the mounting of the base 25; and on the other hand, the device is guided through the guide channel of the base 25 into the second sealing channel 221 of the second sealing element 22.

As shown in fig. 5a, 5b and 6, in order to make two adjacent sealing members more closely stacked, a better sealing function is achieved. 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 gaskets 23.

Alternatively, 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 trapezoidal, the short side of the trapezoid is formed on the outer peripheral wall of the circular body, and the long side of the trapezoid serves as the outer peripheral wall of the gasket 23 and fits with the inner hole wall of the housing 26; correspondingly, the proximal end and the distal end of the outer peripheral wall of the first support ring 241 are respectively provided with a third inclined surface 2411; the trapezoidal oblique sides 232 of the two gaskets 23 are respectively in close contact with the same inclination angle of one third oblique side 2411, and the third oblique sides 2411 exert a squeezing force on the trapezoidal oblique sides 232, so that the outer peripheral wall of the gasket 23 is further in close contact with the inner hole wall of the housing 26, and the outer peripheral wall of the gasket 23 and the inner hole wall of the housing 26 are kept in a sealed state.

As shown in fig. 5a and 5b, the second support ring 242 is disposed between the gasket 23 and the second seal 22, and supports the second seal 22 and the gasket 23.

Optionally, a guide cylinder 224 is further provided on the distal end of the second annular base 222 of the second seal 22, and the second projection 223 is located in the guide cylinder; the second support ring 242 is sleeved outside the guide cylinder, the proximal end of the second support ring 242 abuts against the distal end face of the second annular base 222, the distal end face of the second support ring 242 is provided with a fourth inclined face 2421 which abuts against and is matched with the trapezoidal inclined edge 232 of the gasket 23, and the fourth inclined face 2421 has the same function as the third inclined face 2411, and applies a pressing force to the trapezoidal inclined edge of the gasket 23, so that the outer peripheral wall of the gasket 23 is further ensured to be in sealing abutment with the inner hole wall of the housing 26.

Similarly, the proximal end surface of the first seal member 21 is provided with a fifth inclined surface that engages with the inclined edge 232 of the trapezoidal shape of the adjacent packing 23.

In a modified embodiment, the first support ring 241 and the second support ring 242 may not be provided with the inclined surfaces, the gasket 23 may not be provided with corresponding trapezoidal inclined edges, the support rings only serve as supports, and the outer peripheral walls of the first sealing member, the second sealing member, and the gasket are in close contact with the inner hole wall of the housing to achieve sealing connection.

As a modification, the second sealing member 22 or the gasket 23 may not be provided, and the base 25 and the first sealing member 21 may be provided to achieve the hemostatic effect. Or, the base can be omitted, only the first sealing element is needed to be arranged, the peripheral edge of the first sealing element can be directly sealed and clamped in the circumferential groove of the inner hole wall of the shell, and the first sealing element and the shell are mounted in a sealing mode. Further, the hemostatic valve 2 may also be a one-way valve of other structure, and is not limited to the hemostatic valve 2 mentioned above.

Alternatively, as shown in fig. 5a, the side wall of the housing 26 is provided with a connecting channel 262; as shown in fig. 1, a three-way valve 263 is further included, the three-way valve 263 is connected to the connecting channel 262 through a first pipeline 264, and a required liquid is delivered into the expansion pipe 1 through the three-way valve 263. For example, the first pipeline 264 is a tube made of a softer material, such as a PU tube or a silicone tube. The three-way valve 263 may alternatively be a three-way stopcock valve, which functions to vent the interior of the stent 1 prior to use of the sheath, as well as to vent air entrained by incoming instruments into the stent 1 during use.

Example 2

An embodiment of the present invention provides a vascular sheath device, which is different from the vascular sheath device provided in embodiment 1 in that:

the stent does not include the mounting portion 12, includes only the deformed portion 11, and the deformed portion 11 may be one or two, or more. When the deformation part 11 is one, the first end 111 and the second end 112 of the deformation part 11 form a closed ring, and when an instrument is arranged in the expansion tube 1 in a penetrating way and radial expansion force is applied to the deformation part 11, the radial direction of the deformation part 11 is expanded so as to change the diameter of an inner hole of the deformation part 11. When the deformed portion 11 is plural, the first ends 111 of any two adjacent deformed portions 11 are connected to the second end 112 of another deformed portion to form a ring-shaped pipe, and the extension pipe 1 is formed entirely with the deformed portion 11 in the circumferential direction thereof to further increase the amount of radial deformation of the extension pipe.

Example 3

The invention provides a matching structure of a blood vessel sheath device and a pre-dilator, which comprises the blood vessel sheath device and the pre-dilator provided in the embodiment 1 or the embodiment 2 as shown in fig. 1 and fig. 13. The pre-expander has an outer diameter larger than the inner diameter of the expanding tube 1 in the initial state, and applies a radial expansion force to the expanding tube 1 when the pre-expander enters the expanding tube 1.

The matching structure can realize the passing of blood vessels with different diameters and surgical instruments with different sizes by adopting the blood vessel sheath device, thereby increasing the adaptability of the matching structure.

For the pre-dilator, preferably, as shown in fig. 13, the pre-dilator comprises a pre-dilator tube 31, and a second head 32 provided on the distal end of the pre-dilator tube 31, the second head 32 having an outer diameter larger than the inner diameter of the dilating tube 1 in the initial state.

When the traction guide wire pulls the expansion tube 1 of the vascular sheath device to enter a blood vessel, a pre-expander is needed to pre-expand the expansion tube 1, so that the diameter of an inner hole of the expansion tube 1 is increased, and the expansion tube 1 is easily expanded by a subsequent instrument and then passes through the expansion tube 1 to perform required operation. In addition, when the pre-expander pre-expands the expanding tube 1, the second head 32 of the pre-expanding tube 31 passes through the head cap 14 of the expanding tube 1, and the distal end of the head cap 14 is torn open, so that the subsequent instrument can pass through the head cap conveniently.

Preferably, as shown in fig. 14, the outer peripheral wall of the second head portion 32 is provided with a return groove 321 extending axially therealong, and proximal and distal ends of the return groove 321 are open. When the second head 32 of the pre-dilator is withdrawn from the dilation tube 1 after pre-dilating the dilation tube 1, since the two ends of the backflow groove 321 are open, the medium pressure at the two ends of the backflow groove 321 is consistent, and the blood at the proximal end of the backflow groove 321 can flow back to the distal end of the backflow groove 321 through the backflow groove 321, so that the blood cannot be taken out of the body.

One or two return grooves 321 may be provided, and the specific number may be set according to actual requirements.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A vascular sheath device, comprising

A housing (26);

a haemostatic valve (2) sealingly arranged over an opening at the proximal end of the housing (26);

an expansion tube (1) mounted on a distal opening of the housing (26);

the expansion pipe (1) comprises at least one deformation part (11) distributed along the circumferential direction of the expansion pipe, and a first end (111) of the deformation part (11) along the circumferential direction of the expansion pipe (1) is distributed in an S-shaped bending way towards a second end (112) of the expansion pipe to form a ring shape;

the deformation part (11) can be radially expanded along the expansion pipe (1) under the expansion force in the radial direction of the expansion pipe (1) to be in an expanded state.

2. The vessel sheath device according to claim 1, wherein the dilating tube (1) further comprises at least one mounting portion (12), and the first end (111) and the second end (112) of the deforming portion (11) are respectively connected with the adjacent deforming portion (11) or mounting portion (12) thereof, so that all the deforming portion (11) and mounting portion (12) enclose a ring shape.

3. The vascular sheath device according to claim 2, wherein the deformation portions (11) and the mounting portions (12) are alternately distributed in the circumferential direction of the dilation tube (1).

4. The vascular sheath device according to claim 1, wherein the number of the deformation portions (11) is at least two, and the first end (111) of the former deformation portion (11) is connected with the second end (112) of the latter deformation portion (11) in two adjacent deformation portions (11) along the circumferential direction of the dilating tube (1).

5. The vascular sheath device according to claim 1, characterized in that the deformation portion (11) comprises an inner layer section (11a), at least one middle section (11b) and an outer layer section (11c) which are sequentially distributed in a laminated manner from inside to outside along the radial direction of the dilating tube (1); the inner layer section (11a), the at least one middle section (11b) and the outer layer section (11c) are sequentially connected through a bent arc section (11d) to be bent in an S direction; or the deformation part (11) comprises an inner layer section, at least one middle section and an outer layer section which are distributed in a laminated mode along the circumferential direction of the expansion pipe (1); the inner layer section, the at least one middle section and the outer layer section are sequentially connected through the bent arc sections, so that the deformation part (11) is distributed along a wavy line in the S direction along the circumferential direction of the expansion pipe (1).

6. The vascular sheath device according to claim 1, wherein the deformation portion (11) is made of a deformable material; the deformation portion (11) is switchable between an expanded state and an initial state; in the initial state, the expansion force is removed, and the deformation part (11) contracts and resets along the radial direction of the expansion pipe (1).

7. The vessel sheath device according to claim 2, further comprising a flexible tube (13) sleeved outside the expansion tube (1), wherein the expansion tube (1) tends to maintain an initial state of radial contraction by a radial restraining force of the flexible tube (13).

8. Vascular sheath device according to claim 7, characterised in that at least part of the mounting portion (12) of the dilation tube (1) is glued to the flexible tube (13).

9. The vessel sheath device according to claim 7, further comprising a head cap (14) provided on a distal end of the dilation tube (1);

the head cap (14) is provided with at least one first deformation joint (141) and at least one connecting part arranged at the proximal end and/or the distal end of the first deformation joint (141) so as to connect the parts of the head cap on two sides of the first deformation joint;

the head cap (14) is radially expanded by the first deformation joint (141) as the deformation portion (11) expands.

10. The vascular sheath device according to claim 9, wherein the connecting portions are at least two, and the length of the first deformation joint (141) is not less than the length of the connecting portions.

11. The sheath device according to claim 9, wherein one of the proximal end of the head cap (14) and the distal end of the mounting portion (12) of the stent (1) is provided with a locking groove (151) extending axially along the stent (1), and the other is provided with a locking protrusion (152) extending axially along the stent (1), and the locking protrusions (152) are locked in the locking grooves (151) in a one-to-one correspondence, so that the head cap (14) is connected to the mounting portion (12).

12. The vascular sheath device according to claim 11, wherein the head cap (14) is fused with a platinum-iridium alloy material; or the developing ring (4) is welded at the joint of the clamping protrusion (152) and the clamping groove (151), and a second deformation joint (41) corresponding to the first deformation joint (141) is arranged on the developing ring (4).

13. Vessel sheath device according to claim 11, characterized in that the outer wall surface of the head cap (14) is provided with at least one receiving groove (142) for receiving glue for adhesively connecting at least the head cap (14) to the inner wall of the hose (13) at the receiving groove (142); or a first bulge is formed between two adjacent clamping grooves (151) on the head cap (14), a step surface is formed between the first bulge and the head cap (14), the far end of the hose (13) is sleeved on the first bulge, the end surface of the far end of the hose (13) abuts against the step surface, and the hose (13) and the first bulge are discontinuously bonded and fixed by glue.

14. Vascular sheath device according to claim 7, characterised in that the outer circumferential wall of the flexible tube (13) is coated with a hydrophilic coating.

15. The vascular sheath device according to claim 7, wherein the dilation tube (1) comprises a mounting section (16) and a main body section (17) integrally formed from a proximal end towards a distal end;

in an initial state without radial expansion force, the deformation part (11) at the proximal end of the mounting section (16) is in an expanded state, the deformation part of the main body section (17) is distributed in an S-shaped bending way, and the mounting section (16) is in a conical pipe with the outer diameter gradually reduced from the proximal end to the distal end so as to be formed on the proximal end of the main body section (17) in a transition mode;

the expansion tube also comprises a fixing mechanism arranged on the proximal end of the expansion tube (1); the fixing mechanism comprises a fixing ring (28) which is spliced with the mounting section (16), the fixing ring (28) is sleeved outside the far end of the shell (26), and the near end of the hose (13) is sleeved outside the fixing ring (28); and

a locking member (27) fitted out of the distal end of the housing (26) and clamping the fixing ring (28) and the proximal end of the hose (13) between the locking member (27) and the housing (26).

16. The vascular sheath device according to claim 15, wherein the distal end of the fixing ring (28) is a tapered portion (281) matched with the tapered tube, and the tapered portion (281) is provided with mounting grooves (282) suitable for being embedded with the mounting portions (12) on the mounting section (16) in a one-to-one correspondence manner.

17. Vascular sheath device according to claim 16, characterised in that the proximal end of the securing ring (28) presents a flared portion (283) which is enlarged towards the housing (26), the flared portion (283) being clamped between the housing (26) and the locking member (27).

18. Vascular sheath device according to claim 15, characterised in that the locking member (27) is screw-fitted on the distal end of the housing (26); and/or

At least part of the hose (13) is adhesively connected to the mounting section (16) and the fixing ring (28).

19. Vascular sheath device according to claim 15, characterised in that the distal end of the securing ring (28) is provided with at least one third deformation joint (2811) extending axially along it.

20. Vascular sheath device according to claim 1, characterised in that the haemostatic valve (2) comprises a first seal (21);

the first sealing member (21) comprises a first annular base body (212), and the outer peripheral wall of the first annular base body (212) is hermetically arranged on the inner hole wall of the shell (26); at least one sealing protrusion (213) formed on the first annular base body (212) and protruding toward a distal end of the first annular base body (212), a first sealing channel (211) being provided on an end surface of the sealing protrusion (213);

two side walls of the sealing bulge (213) are slope surfaces, the slope surfaces are inclined from the far end of the sealing bulge (213) to the root part of the near end of the sealing bulge, and the two side walls of the sealing bulge (213) press the sealing bulge (213) under the pressure of medium at the far end of the sealing bulge so as to force the first sealing channel (211) to tend to be closed.

21. The vascular sheath device according to claim 20, wherein the slope surface comprises a first inclined surface (2131) and a second inclined surface (2132), a proximal end of the first inclined surface (2131) is connected with a distal end of the second inclined surface (2132), a distal end of the first inclined surface (2131) is connected with the end surface of the sealing protrusion (213), a proximal end of the second inclined surface (2132) is molded on the first annular base body (212), and an inclination angle of the first inclined surface (2131) with respect to the end surface of the sealing protrusion (213) is different from an inclination angle of the second inclined surface (2132) with respect to the end surface of the sealing protrusion (213).

22. The vascular sheath device of claim 20, wherein the first sealing channel is a straight or cross or mitre type seam.

23. Vascular sheath device according to claim 20, characterised in that the haemostatic valve (2) further comprises a second seal (22) which is distributed in a stack with the first seal (21);

the second sealing element (22) comprises a second annular base body (222), and the outer peripheral wall of the second annular base body (222) is hermetically arranged on the inner hole wall of the shell (26); a second protrusion (223) formed in the inner hole of the second annular base body (222), the second protrusion (223) protruding towards the distal end of the second annular base body (222), a second sealing channel (221) being provided on the second protrusion (223), the second sealing channel (221) communicating with the first sealing channel (211).

24. The vascular sheath device according to claim 23, wherein the second sealing member (22) further comprises at least one first reinforcing rib (225), one end of the first reinforcing rib (225) is fixed to an outer wall surface of the distal end of the second projection (223), and the other end is fixed to an inner wall surface of the second annular base body (222).

25. The vascular sheath device according to claim 23, wherein the hemostatic valve (2) further comprises at least one sealing gasket (23) stacked and sandwiched between the first sealing member (21) and the second sealing member (22), a third sealing channel (231) is disposed on the sealing gasket (23), and the third sealing channel (231), the first sealing channel (211) and the second sealing channel (221) are distributed on the axis of the dilating tube (1).

26. The vascular sheath device of claim 25,

the third sealing channel (231) comprises a through hole and/or at least one cutting groove (234), and when the third sealing channel (231) comprises the through hole and the at least one cutting groove (234), the at least one cutting groove (234) is distributed on the periphery of the through hole and is communicated with the through hole;

and/or the distal end face and/or the proximal end face of the sealing gasket (23) is provided with at least one second reinforcing rib (233).

27. The vascular sheath device according to claim 25, wherein the third sealing channel (231) comprises a cross-shaped cutting groove and an X-shaped cutting groove which are arranged on the distal end surface and the proximal end surface of the sealing gasket (23) or the X-shaped cutting groove and the X-shaped cutting groove which are arranged on the distal end surface and the proximal end surface of the sealing gasket (23), and the cross-shaped cutting groove and the X-shaped cutting groove are combined to form a cutting groove in a cross structure; alternatively, the third sealed passage is the same as the second sealed passage.

28. The vascular sheath device of claim 25,

the hemostatic valve (2) comprises at least two sealing gaskets (23) and a first support ring (241) arranged between every two adjacent sealing gaskets (23);

and/or a second support ring (242) arranged between the sealing gasket (23) and the second sealing element (22).

29. Vascular sheath device according to any one of claims 20 to 28, characterised in that the haemostatic valve (2) further comprises a base (25);

a first annular step (261) is arranged in the inner hole of the shell (26); the base (25) is provided with an annular flange (251), the base (25) is tightly embedded in the proximal opening of the shell (26), and the annular flange (251) is hooked on the proximal end face of the shell (26);

the first seal (21) is tightly clamped between the distal end face of the seat (25) and the first annular step (261).

30. The vascular sheath device according to claim 29, wherein at least one clamping protrusion (252) protruding radially is provided on the outer peripheral wall of the base (25), the housing (26) is provided with clamping holes (265) for the clamping protrusions (252) to be correspondingly inserted one by one, and the base (25) and the housing (26) are connected by inserting the clamping protrusions (252) into the clamping holes (265).

31. The vascular sheath device according to claim 1, wherein the side wall of the housing (26) is provided with a connecting channel (262); the device also comprises a three-way valve (263), and the three-way valve (263) is connected with the connecting channel (262) through a first pipeline (264).

32. The vascular sheath device according to claim 28, wherein the outer peripheral wall of the first support ring (241) is provided with a third inclined surface (2411) at the proximal end and the distal end, respectively; the inclined edges (232) at the peripheries of the two sealing gaskets (23) are respectively and tightly abutted with the inclined angle of one third inclined surface (2411);

and/or a guide cylinder (224) is further arranged on the distal end of the second annular base body (222) of the second sealing element (22), and the second bulge (223) is positioned in the guide cylinder; the second support ring (242) is sleeved outside the guide cylinder, the near end of the second support ring (242) abuts against the far end face of the second annular base body (222), and a fourth inclined face (2421) which is in abutting fit with the inclined edge (232) at the periphery of the sealing gasket (23) is arranged on the far end face of the second support ring (242);

and/or a fifth inclined surface matched with the inclined edge (232) at the periphery of the adjacent sealing gasket (23) is arranged on the proximal end surface of the first sealing element (21).

33. The vascular sheath device according to claim 16, wherein the inner wall surface of the distal end of the securing ring (28) is flared from its proximal end towards the distal end.

34. The vascular sheath device according to claim 20, wherein the sealing protrusion (213) comprises four branch bosses, the branch bosses form a cross-shaped protrusion, two side walls of each branch boss are respectively provided with a slope, and the first sealing channel (211) on the end surface of the cross-shaped protrusion forms a cross-shaped slit.

35. A matching structure of a vascular sheath device and a pre-dilator is characterized by comprising

The vascular sheath device of any one of claims 1-34;

a pre-expander (3) comprising a pre-expander tube (31), the pre-expander tube (31) having an outer diameter larger than the inner diameter of the expander tube (1) in an initial state.