WO2023125901A1 - 一种密封系统及输送鞘 - Google Patents

一种密封系统及输送鞘 Download PDF

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Publication number
WO2023125901A1
WO2023125901A1 PCT/CN2022/143792 CN2022143792W WO2023125901A1 WO 2023125901 A1 WO2023125901 A1 WO 2023125901A1 CN 2022143792 W CN2022143792 W CN 2022143792W WO 2023125901 A1 WO2023125901 A1 WO 2023125901A1
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WIPO (PCT)
Prior art keywords
sealing
distal end
sealing gasket
gasket
sealing system
Prior art date
Application number
PCT/CN2022/143792
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English (en)
French (fr)
Inventor
刘晓颖
肖本好
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先健科技(深圳)有限公司
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Publication of WO2023125901A1 publication Critical patent/WO2023125901A1/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
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J15/00—Sealings
    • F16J15/02—Sealings between relatively-stationary surfaces
    • F16J15/06—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces
    • F16J15/10—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces with non-metallic packing
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J15/00—Sealings
    • F16J15/02—Sealings between relatively-stationary surfaces
    • F16J15/06—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces
    • F16J15/10—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces with non-metallic packing
    • F16J15/104—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces with non-metallic packing characterised by structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E60/00—Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
    • Y02E60/10—Energy storage using batteries

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a sealing system and a delivery sheath.
  • the delivery sheath is mainly used to establish a connection channel between human blood vessels and the outside world, so that other devices such as sheath cores, guide wires, and catheters can enter and exit the blood vessels.
  • the delivery sheath needs to include a sealing system to ensure the sealing after the delivery sheath penetrates into the human body and the connection channel established by other instruments through the delivery sheath to prevent blood leakage; at the same time, it must be easy to push other instruments along the delivery sheath.
  • the sealing gasket in the delivery sheath is easily folded due to the impact of blood or the back and forth delivery of other instruments, so that the sealing of the delivery sheath during the operation cannot be guaranteed, resulting in leakage. Blood is not conducive to the safety of the operation.
  • the technical problem to be solved by the present invention is to provide a sealing gasket in the prior art that is easily folded due to the shock of blood or being transported back and forth in the delivery sheath, resulting in insufficient sealing.
  • a sealing system and delivery sheath are easily folded due to the shock of blood or being transported back and forth in the delivery sheath, resulting in insufficient sealing.
  • an embodiment of the present invention provides a sealing system, including a connecting seat and a sealing assembly located in the connecting seat, the sealing assembly protrudes toward the distal end, and the distal end of the sealing assembly includes a polygonal cut noodle.
  • sealing system according to the present invention can also have the following additional technical features:
  • the polygonal cutting surfaces include triangular cutting surfaces.
  • the angle formed by two adjacent polygonal cutting surfaces at the distal end side is greater than 180°.
  • the sealing assembly includes a first sealing gasket and a second sealing gasket, the second sealing gasket is located at the distal end of the first sealing gasket, and the first sealing gasket
  • the gasket includes a distal plane that abuts against the second sealing gasket
  • the second sealing gasket includes an abutting portion and a buffer portion that arches from the abutting portion to the distal end, and the abutting portion Abutting against the distal end plane of the first sealing gasket
  • the polygonal cutting surface is provided at the distal end of the buffer portion.
  • the sealing system is formed with an axial passage, and the sealing assembly is provided with a perforation communicating with the axial passage, and the perforation includes a The cuts for the second gasket are described.
  • the cut length of the second sealing gasket is greater than the cut length of the first sealing gasket.
  • the cut line of the first sealing gasket includes a first cut line and a second cut line located on the distal plane, the first cut line and the second cut line cross, and the cross point penetrates the first sealing gasket.
  • the buffer portion includes a connecting surface arranged in a radial direction
  • the cut marks of the second sealing gasket include a third cutting line and a fourth cutting line located on the connecting surface, so The third cutting line intersects the fourth cutting line, and the intersection point penetrates the second sealing gasket.
  • the cuts of the first sealing gasket and the cuts of the second sealing gasket are not in the same axial plane.
  • the proximal end of the buffer portion includes a smooth rounded surface.
  • the second sealing gasket is an arched silicone gasket as a whole, the abutting portion of the second sealing gasket is ring-shaped, and the proximal end of the buffer portion is smooth.
  • the circular arched surface defines the height of the circular arch at the proximal end of the buffer part as H, and defines the annular inner diameter of the abutting part as L, then H and L satisfy: 1/4 ⁇ H/L ⁇ 1 .
  • the buffer portion includes a connection surface and a plurality of oblique cut surfaces
  • the connection surface is located in the central area of the distal end side of the buffer portion
  • the oblique cut surfaces connect the
  • the connection surface and the abutment portion define the thickness of the abutment portion of the second sealing gasket as d1, define the thickness of the oblique cutting surface as d2, and define the thickness of the connection surface as d3, then d1 , d2 and d3 satisfy, d1>d2>d3.
  • the connecting seat includes a gland, a connecting joint, and a front end cover sequentially from the proximal end to the distal end, the gland is fixedly connected to the proximal end of the connecting joint, and the front end cover is fixed Connected to the far end of the connecting joint, the proximal end of the gland is provided with a first through hole, the distal end of the front cover is provided with a second through hole, and the first through hole is connected to the second through hole.
  • An axial channel is formed between the holes, a replaceable joint is provided on the side of the connecting seat near the far end, and the sealing assembly is located between the gland and the connecting joint.
  • the present invention also provides a delivery sheath, comprising the above-mentioned sealing system and a sheath tube communicating with the sealing system and extending to the distal end.
  • the above-mentioned sealing system through the sealing component including a polygonal cutting surface protruding toward the distal end, can not only disperse the impact force of blood, achieve rapid force unloading, and prevent the sealing of the distal surface of the sealing component due to too much instantaneous force and untimely unloading.
  • the collapse or folding of the component can also provide support for itself, preventing the sealing component from being folded when other instruments are withdrawn, thereby ensuring the sealing of the sealing component, preventing blood leakage, reducing surgical risk, and improving surgical safety.
  • Fig. 1 is a schematic structural view of a delivery sheath according to an embodiment of the present invention
  • Fig. 2 is a structural schematic diagram of a sealing system according to an embodiment of the present invention.
  • Figure 3 is an exploded view of Figure 2;
  • Fig. 4 is the plan view of Fig. 2;
  • Fig. 5 is a sectional view of Fig. 4;
  • Fig. 6 is a schematic structural view of a first sealing gasket according to an embodiment of the present invention.
  • Fig. 7 is a schematic diagram of the distal end surface of the first sealing gasket according to an embodiment of the present invention.
  • Fig. 8 is a sectional view along the center direction of Fig. 7;
  • Fig. 9 is a schematic diagram of the distal end face of the second sealing gasket according to an embodiment of the present invention.
  • Fig. 10 is a schematic diagram of the three-dimensional structure of Fig. 9;
  • Figure 11a is a sectional view along the center direction of Figure 10;
  • Fig. 11b is a schematic diagram of defining the arc distance of the buffer portion of the second sealing gasket according to an embodiment of the present invention.
  • Fig. 12 is a schematic structural view of a delivery sheath being penetrated by a sheath core according to an embodiment of the present invention
  • Fig. 13 is a schematic structural view of a sealing system penetrated by a sheath core according to an embodiment of the present invention
  • Fig. 14 is a sectional view of Fig. 13;
  • Fig. 15 is a partial structural schematic diagram of a sealing assembly penetrated by a sheath core according to an embodiment of the present invention.
  • Fig. 16 is a structural schematic diagram of another angle where the sealing assembly is penetrated by the sheath core according to an embodiment of the present invention.
  • proximal end refers to the end close to the operator
  • proximal side refers to the side close to the operator
  • distal end refers to the end away from the operator
  • distal side refers to the side far away from the operator. side of the person.
  • the present invention provides an adjustable delivery sheath 100 , including a sealing system 10 , a handle shell 20 and a sheath tube 30 .
  • the sealing system 10 is arranged in the handle shell 20, and the sheath tube 30 communicates with the sealing system 10 to extend to the distal end, and passes through the far end of the handle shell 20, that is, the proximal end of the sheath tube 30 is connected to the far end of the sealing system 10.
  • the ends are connected so that when the sheath tube 30 is inserted into the human body, the sealing system 10 forms a sealed cavity to prevent blood from overflowing.
  • the handle shell 20 also includes a bending system for realizing the bending of the sheath tube 30, which will not be described in detail here.
  • the present invention provides a kind of sealing system 10, as shown in Fig. 3-4 combined with Fig.
  • the connecting seat 11 cooperates with the sealing assembly 12 to form an axial channel 13 communicating with the sheath tube 30.
  • the axial channel 13 can allow other instruments to pass through from the proximal end to the distal end of the delivery sheath 100, thereby delivering other instruments. to the human body.
  • the sealing assembly 12 protrudes toward the distal end, and the distal end of the sealing assembly 12 further includes a polygonal cutting surface at the distal end.
  • the connection base 11 sequentially includes a gland 111 , a connection joint 112 , a replaceable joint 113 and a front end cover 114 from the proximal end to the distal end.
  • the gland 111 is fixedly connected to the proximal end of the connection joint 112 so as to press the sealing assembly 12 between the gland 111 and the connection joint 112
  • the front end cover 114 is fixed to the distal end of the connection joint 112 .
  • the proximal end of the gland 111 is provided with a first through hole 1111
  • the distal end of the front end cover 114 is provided with a second through hole 1141
  • an axial channel 13 is formed between the first through hole 1111 and the second through hole 1141.
  • the connecting joint 112 is a T-shaped joint. As shown in FIG. 3 , the proximal end of the T-shaped joint is fixedly connected with the gland 111 by threads, and the far end of the T-shaped joint is fixedly connected with the front end cover 114 by threads.
  • the bottom fitting of the T-fitting is connected with a three-way valve.
  • the replaceable connector 113 is provided with a small hole 1131 communicating with the bottom connector at the position corresponding to the T-shaped bottom connector, as shown in FIG. 5 , so as to facilitate the implementation of other operations such as drainage or injection during the operation.
  • the bottom joint of the T-shaped joint is connected with a three-way valve 15 through a hose 14, as shown in FIG. 5 in conjunction with FIG. 1 . When the delivery sheath 100 is inserted into the human body, the bottom joint of the T-shaped joint is closed by the three-way valve 15 to keep the sealing system 10 sealed, as shown in FIG. 5 in combination with FIG. 1 .
  • a hollow replaceable joint 113 is also provided on the side near the distal end of the connecting seat 11, and the replaceable joint 113 is interference-fitted with the connecting joint 112 so as to fix the replaceable joint 113 on the connecting joint 112 inside.
  • the side surface of the proximal end of the sheath tube 30 is bonded in the second through hole 1141 of the front end cover 114 and communicates with the axial channel 13 of the sealing system 10. With a force toward the proximal end, the proximal end surface of the sheath tube 30 abuts against the distal end surface of the replaceable joint 113, so that the replaceable joint 113 supports the sheath tube 30 in the axial direction.
  • the sealing assembly 12 is located in the connection seat 11 , the sealing assembly 12 includes a first sealing gasket 121 and a second sealing gasket 122 , and the second sealing gasket 122 is located at the distal end of the first sealing gasket 121 .
  • the first sealing gasket 121 is a flat silicone gasket, and the proximal central area of the first sealing gasket 121 faces the distal end of the first sealing gasket 121 The direction is depressed to form a first groove 1211, and the distal end of the first sealing gasket 121 is a plane, which reduces the thickness of the central area of the first sealing gasket 121, as shown in Figure 8, which facilitates the pushing of medical instruments. Or when the soft tip guide wire passes through the first sealing gasket 121 for the first time, it is easier to pass through.
  • the second sealing gasket 122 is an arched silicone gasket
  • the second sealing gasket 122 includes an abutment part 1221 and a buffer part 1222, as shown in Figure 11a, the abutment part 1221 It is arranged on the proximal side of the buffer part 1222 in the circumferential direction, the proximal end of the contact part 1221 is in contact with the distal plane 1212 of the first sealing gasket 121 in the circumferential direction, and the distal end of the contact part 1221 is in contact with the proximal end of the T-shaped joint. The end faces abut against each other along the circumferential direction.
  • the buffer part 1222 is an arched structure formed by arching and extending from the inner side of the abutment part 1221 to the distal end in the circumferential direction. There is a space between the arched structure and the first sealing gasket 121.
  • the proximal end of the buffer part 1222 includes a The support section 12221 arranged axially and circumferentially and the buffer section 12222 connected by a plurality of polygonal cutting surfaces are shown in Fig. 10 in combination with Fig. 11a. Wherein, the supporting section 12221 is used for transitionally connecting the buffering section 12222 and the abutting portion 1221 , and supporting the buffering section 12222 in the axial direction.
  • the distal end surface of the buffer portion 1222 includes a polygonal cutting surface that protrudes toward the distal direction, and the angle formed by two adjacent polygonal cutting surfaces on the distal side is greater than 180°, that is, the angle between the two adjacent polygonal cutting surfaces is greater than 180°.
  • the common side between them is raised toward the distal side, as shown in Figure 10-11a, to improve the support of the polygonal cutting surface.
  • the polygonal cutting surface divides the distal end surface of the second sealing gasket 122 into multiple polygonal cutting surfaces
  • the multiple polygonal cutting surfaces of the buffer section 12222 will impact The force is dispersed on multiple surfaces, and the impact force of the blood can be quickly released, preventing the second sealing gasket 122 from collapsing or turning over due to too much instantaneous force on the distal surface of the second sealing gasket 122 and untimely unloading of the force, resulting in Insufficient sealing of the sealing assembly 12 causes blood to overflow, and at the same time, adjacent polygonal cutting surfaces provide support to each other, which can further buffer blood flow and prevent collapse or folding.
  • the common side between two adjacent polygonal cutting surfaces protrudes toward the distal end side, so as to increase the support between the polygonal cutting surfaces.
  • the distal side of the buffer section 12222 includes a hexagonal connecting surface 12222a and an oblique cutting surface 12222b located in the central area along the radial direction, and the oblique cutting surface 12222b is used for In connecting the support section 12221 and the connecting surface 12222a, and the oblique cutting surface 12222b is a triangular cutting surface, that is, the polygonal cutting surface includes a hexagonal connecting surface 12222a arranged radially in the central area of the buffer part and a plurality of triangular
  • the oblique cutting surface 12222b due to the stable triangular structure, when the conveyed instrument is retracted or the distal surface of the second sealing gasket is impacted by blood, the triangular cutting surface can provide stable support to more stably remove the impact force Or prevent folding, thereby providing a better seal to prevent blood from spilling.
  • first sealing gasket 121 which is a flat gasket
  • buffer section 12222 of the second sealing gasket 122 is divided into bulges toward the distal end due to its distal end.
  • the unique polygonal cutting surface can release the force in time, so that it is not easy to fold or collapse, and the sealing system can continue to maintain good sealing performance.
  • the proximal end of the buffer part 1222 also includes a smooth rounded arched surface, and when the second sealing gasket 122 is impacted by blood, the arched shape can reach the unloading force faster, so as to ensure the sealing performance of the sealing assembly 12 , to prevent blood leakage, and at the same time provide a certain degree of support to the distal surface of the second arch gasket to prevent folding;
  • the proximal end of the second sealing gasket 122 is set as a smooth circular arch surface or hemispherical surface, reducing the second The thickness of the most central area of the second sealing gasket 122 (corresponding to the place where the cut is set on the connecting surface) makes it easier and less labor-saving for the medical device to be pushed along the delivery sheath 100, and it is easier to enter the diseased part, thereby shortening the operation time and reducing the pain of the patient , Improve the efficacy of surgery.
  • the second sealing gasket is an arch-shaped silicone gasket as a whole
  • the abutment part of the second sealing gasket is ring-shaped
  • the proximal end of the buffer part It is a smooth arched surface
  • H the height of the arch at the proximal end of the buffer
  • L the inner ring diameter of the abutting portion
  • H and L satisfy: 1/4 ⁇ H/L ⁇ 1.
  • H/L 1/2, that is, when the circular arch is hemispherical, the supporting force of the arched part as the buffer part is better.
  • the buffer part When H/L ⁇ 1/4 or even tends to 0, the buffer part may not even be able to play a supporting role, thereby reducing the sealing effect of the second sealing gasket, and the second sealing gasket is equivalent to a flat gasket.
  • the sealing assembly composed of two sealing gaskets and the flat first sealing gasket increases the thickness of the flat gasket, making it difficult to puncture the sealing assembly.
  • the distance between the connecting parts is relatively long (when H/L is greater than 1), the proportion of the buffer part to the whole of the second sealing gasket is too large, and it is difficult to fix and compress the abutting part.
  • the thickness of the abutting part of the second sealing gasket is defined as d1
  • the thickness of the triangular cutting surface (oblique cutting surface) is d2
  • the thickness of the connecting surface is d3.
  • connection surface in the central area is the thinnest, and when the instrument passes through the connection surface, it is convenient to push and withdraw;
  • the thickness of the triangular cutting surface is moderate and greater than the thickness of the connection surface, so that When pushing the instrument (piercing the connection surface), the triangular cutting surface can provide better support for the connection surface (the top of the arch), that is, when pushing the instrument (the instrument penetrates from the proximal end to the distal end), the connection surface
  • the distal end is turned over to wrap the instrument, and the instrument has a pulling force on the connecting surface to the distal end so that the connecting surface pulls the triangular cutting surface at the distal end.
  • the triangular cutting surface can provide a certain reaction to the connecting surface
  • the force makes the connection surface wrap the device better, and the sealing performance is better.
  • the polygonal cutting surface provides support for the connection surface to prevent the connection surface from being folded at the proximal end;
  • the connection part is set as the thickest base part of the arch, which can provide stable support for the overall buffer part, thereby providing sufficient support force for the polygonal cutting surface, as shown in Figure 11b.
  • the sealing assembly 12 is provided with a perforation 123 communicating with the axial channel 13.
  • the perforation 123 includes incomplete openings provided in the central area of the first sealing gasket 121 and the second sealing gasket 122, which can meet the When transporting delivery devices of different specifications, it can still wrap the sheath core, guide wire or catheter of the delivery device well to achieve effective sealing.
  • the cut marks of the first sealing gasket 121 include a first cut line 1231 and a second cut line 1232 located at its distal plane 1212 , wherein the first cut line 1231 and the second cut line 1232 cross, and the cross point penetrates the first sealing gasket 121 .
  • the cut marks of the second sealing gasket 122 include a third cut line 1233 and a fourth cut line 1234 located on the connection surface 12222a, the third cut line 1233 intersects with the fourth cut line 1234, And the intersection point penetrates the second sealing gasket 122 .
  • the sealing assembly 12 is composed of two silicone gaskets, only the penetrating cuts at the intersection of the cutting lines can ensure that the sealing assembly 12 can close the proximal end of the sealing system 10 when the sealing system 10 is in a natural state.
  • the incision length of the second sealing gasket 122 at the distal end is greater than the incision length of the first sealing gasket 121 at the proximal end, so that when the instrument punctures the sealing assembly, it is more convenient for the instrument to move toward the distal end. Pushing forward, the strength is lighter, and at the same time, the cut length of the first sealing gasket at the proximal end is smaller, which is more convenient for further leakage prevention.
  • the cut marks of the first sealing gasket 121 and the cut marks of the second sealing gasket 122 are not in the same axial plane.
  • the intersection of the first cutting line 1231 and the second cutting line 1232 is in the shape of a "cross", as shown in Figure 6, and the intersection of the third cutting line 1233 and the fourth cutting line 1234 is in the shape of an "X", as shown in Figure 6
  • the two move to the same radial plane in the axial direction, they form a "m" shape, so that the cutting line of the first sealing gasket 121 and the cutting line of the second sealing gasket 122 are not on the same plane in the axial direction Inwardly, that is, viewed from the axial direction, the cutting line on the first sealing gasket 121 does not overlap with the cutting line on the second sealing gasket 122 .
  • the position where the distal end of the second sealing gasket 122 is impacted by the blood does not have a cutting line at the position corresponding to the position of the first sealing gasket 121 in the axial direction.
  • the sealing assembly 12 formed by the cooperation of the first sealing gasket 121 and the second sealing gasket 122 has better sealing performance, and the setting of the cutting line enables the sealing assembly 12 to be easier to push in while still maintaining good sealing performance.
  • the sheath core 200 (device to be delivered) passing through the delivery sheath 100 along the axial channel as an example, as shown in FIGS.
  • the sheath core 200 penetrates into the sealing system 10 (the sheath core 200 moves axially from the proximal end to the distal end)
  • the sheath core 200 penetrates along the kerf of the first sealing gasket 121 and the second sealing gasket 122
  • the intersection is passed through, and the gasket made of silicone is punctured to wrap around the sheath core 200 , as shown in FIGS. 15-16 .
  • the blood flow hits the distal end face of the second sealing gasket along the arrow direction c in FIG.
  • the distal end of the sealing gasket 122 is provided with a polygonal cutting surface, which can quickly remove the impact force of the blood, and prevent the second sealing gasket 122 from collapsing due to too much instantaneous force on the distal surface of the second sealing gasket 122 and untimely force discharge.
  • the polygonal cutting surfaces support each other, which can further buffer the blood flow and prevent the second sealing gasket 122 from collapsing or turning over, so that the sealing system can still maintain an effective seal when transporting other instruments during the operation.
  • the sheath core 200 or other instruments need to be withdrawn after being penetrated along the delivery sheath (the sheath core 200 moves axially from the distal end to the proximal end), when withdrawing, the polygonal cutting surface on the distal side of the buffer part 1222 protrudes toward At the far end, there is good support between the polygonal cutting surfaces, which can prevent the frictional force towards the proximal end caused by the retraction of the sheath core 200 from causing the buffer portion 1222 of the second sealing gasket 122 to fold, thereby preventing blood leakage. Guaranteed airtightness helps to improve the safety and success rate of the operation.
  • the gasket is made of silica gel
  • the second sealing gasket 122 is bonded to the first sealing gasket 121, and then the gland 111 is used to screw the proximal end of the connection joint 112 together, so that the sealing assembly 12 is pressed and fixed.
  • the sealing gasket in the prior art is subjected to a large force and the gasket is folded greatly, it may also cause the fixed part of the gasket to break away from the connecting seat due to excessive deformation of the sealing gasket and be removed with the instrument.
  • the second sealing gasket 122 provided in this embodiment, because of the polygonal cutting surface at the far end, makes the buffer portion 1222 of the second sealing gasket 122 difficult to fold, which can prevent the second sealing gasket 122 from detaching from the
  • the gap between the first sealing gasket 121 and the proximal end of the T-shaped joint is taken out of the sealing system 10 by the instrument, thereby ensuring the tightness of the sealing system 10 .
  • the sealing component protrudes toward the distal end, and the distal end of the sealing component includes a polygonal cutting surface, so that the sealing component can be unloaded in time when encountering the impact of blood, so as to avoid folding or collapse caused by the blood impulse , and the support provided between the polygonal cutting surfaces can reduce the folding caused by the retraction of the instrument, so as to ensure the tightness of the sealing system.
  • the delivery sheath provided by the present invention includes the above-mentioned sealing system, so that the sealing assembly still maintains a good seal during the process of being impacted by blood and instrument delivery, so as to prevent poor sealing caused by blood impact or instrument delivery back and forth during the operation And the bleeding caused by it can improve the safety and success rate of the operation.
  • sealing system provided by the present invention can also be applied to other delivery sheaths.

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Abstract

一种密封系统（10），包括连接座（11）以及位于连接座（11）内的密封组件（12），密封组件（12）朝向远端凸起，且密封组件（12）的远端包括多边形切割面。密封系统（10）通过密封组件（12）包括朝向远端凸起的多边形切割面，不仅可以分散血液冲击力，达到快速卸力，防止密封组件（12）远端表面因瞬时受力太大卸力不及时可能导致的密封组件（12）的坍塌或翻折，还可以对自身提供支撑力，防止其他器械后撤时导致的密封组件（12）的翻折，从而保证密封组件（12）的密封性，防止漏血，降低手术风险，提高手术安全性。

Description

一种密封系统及输送鞘 技术领域
本发明涉及介入医疗器械技术领域，特别是涉及一种密封系统及输送鞘。
背景技术
输送鞘作为心血管介入治疗手术中常用的医疗器械，主要用于建立人体血管与外界的连接通道，以便于鞘芯、导丝、导管等其他器械能够进出血管。输送鞘内需包括密封系统以保证输送鞘穿入人体后以及在其他器械通过输送鞘建立的连接通道时可以保证密封性，以防止漏血；同时还要满足易于其他器械沿输送鞘推入。
现有的输送鞘在术中作为连接通道的过程中，容易因受血液冲击或来回输送其他器械导致输送鞘内的密封垫片翻折，从而无法保证输送鞘在术中的密封性，导致漏血，不利于手术的安全性。
发明内容
本发明要解决的技术问题在于，针对现有技术中密封垫片易因受到血液冲击或其他器械的来回输送导致输送鞘内的密封垫片翻折，从而导致密封性不足方面的缺陷，提供一种密封系统及输送鞘。
本发明解决其技术问题所采用的技术方案是：
一方面，本发明一实施例提供了一种密封系统，包括连接座以及位于所述连接座内的密封组件，所述密封组件朝向远端凸起，且所述密封组件的远端包括多边形切割面。
另外，根据本发明的密封系统，还可具有如下附加的技术特征：
在本发明的一些实施方式中，所述多边形切割面包括三角形切割面。
在本发明的一些实施方式中，相邻的两个所述多边形切割面在远端侧形成的夹角大于180°。
在本发明的一些实施方式中，所述密封组件包括第一密封垫片和第二密封垫片，所述第二密封垫片位于所述第一密封垫片的远端，所述第一密封垫片包 括与所述第二密封垫片抵接的远端平面，所述第二密封垫片包括抵接部以及自所述抵接部向远端拱起的缓冲部，所述抵接部与所述第一密封垫片的远端平面抵接，所述多边形切割面设于所述缓冲部的远端。
在本发明的一些实施方式中，所述密封系统形成有轴向通道，所述密封组件设有与所述轴向通道连通的穿孔，所述穿孔包括设置于所述第一密封垫片和所述第二密封垫片的切痕。
在本发明的一些实施方式中，所述第二密封垫片的切痕长度大于所述第一密封垫片的切痕长度。
在本发明的一些实施方式中，所述第一密封垫片的切痕包括位于所述远端平面的第一切割线和第二切割线，所述第一切割线与所述第二切割线交叉，且交叉点处穿透所述第一密封垫片。
在本发明的一些实施方式中，所述缓冲部包括沿径向设置的连接面，所述第二密封垫片的切痕包括位于所述连接面的第三切割线和第四切割线，所述第三切割线与所述第四切割线交叉，且交叉点处穿透所述第二密封垫片。
在本发明的一些实施方式中，所述第一密封垫片的切痕与所述第二密封垫片的切痕不在沿轴向上的同一平面内。
在本发明的一些实施方式中，所述缓冲部近端包括光滑的圆拱形面。
在本发明的一些实施方式中，所述第二密封垫片为整体呈拱形的硅胶垫片，所述第二密封垫片的抵接部呈环形，所述缓冲部的近端为光滑的圆拱形面，定义所述缓冲部近端的圆拱形的高度为H，定义所述抵接部的环形内直径为L，则，H与L满足：1/4≤H/L≤1。
在本发明的一些实施方式中，H与L满足：H/L＝1/2。
在本发明的一些实施方式中，所述缓冲部包括一个连接面和多个斜向切割面，所述连接面位于所述缓冲部的远端侧中心区域，所述斜向切割面连接所述连接面与所述抵接部，定义所述第二密封垫片的抵接部的厚度为d1，定义所述斜向切割面的厚度为d2，定义所述连接面的厚度为d3，则d1、d2、d3满足，d1＞d2＞d3。
在本发明的一些实施方式中，所述连接座自近端至远端依次包括压盖、连 接接头以及前端盖，所述压盖固定连接于所述连接接头的近端，所述前端盖固定连接于所述连接接头的远端，所述压盖的近端开设有第一通孔，所述前端盖的远端开设有第二通孔，所述第一通孔与所述第二通孔之间形成有轴向通道，所述连接座内靠近远端的一侧设有可替换接头，所述密封组件位于所述压盖与所述连接接头之间。
另一方面，本发明还提供了一种输送鞘，包括上述密封系统以及与所述密封系统连通并向远端延伸的鞘管。
上述密封系统，通过密封组件包括朝向远端凸起的多边形切割面，不仅可以分散血液冲击力，达到快速卸力，防止密封组件远端表面因瞬时受力太大卸力不及时可能导致的密封组件的坍塌或翻折，还可以对自身提供支撑力，防止其他器械后撤时导致的密封组件的翻折，从而保证密封组件的密封性，防止漏血，降低手术风险，提高手术安全性。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明一实施例的输送鞘的结构示意图；
图2是本发明一实施例的密封系统的结构示意图；
图3是图2的爆炸图；
图4是图2的平面图；
图5是图4的剖面图；
图6是本发明一实施例的第一密封垫片的结构示意图；
图7是本发明一实施例的第一密封垫片的远端端面的示意图；
图8是图7沿中心方向的剖面图；
图9是本发明一实施例的第二密封垫片的远端端面的示意图；
图10是图9的立体结构示意图；
图11a是图10沿中心方向的剖面图；
图11b是本发明一实施例的第二密封垫片的缓冲部的拱形距离定义示意图；
图12是本发明一实施例的输送鞘被鞘芯穿入的结构示意图；
图13是本发明一实施例的密封系统被鞘芯穿入的结构示意图；
图14是图13的剖面图；
图15是本发明一实施例的密封组件被鞘芯穿入的部分结构示意图；
图16是本发明一实施例的密封组件被鞘芯穿入的另一角度的结构示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。在本发明的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本申请中“近端”是指靠近操作者的一端，“近端侧”是指靠近操作者的一侧，“远端”是指远离操作者的一端，“远端侧”是指远离操作者的一侧。
请参阅图1-5，本发明提供了一种可调弯的输送鞘100，包括密封系统10、手柄壳20和鞘管30。其中，密封系统10设置于手柄壳20内，鞘管30与密封系统10连通向远端延伸，并从手柄壳20的远端穿出，即，鞘管30的近端与密封系统10的远端连接以使鞘管30穿入人体时，密封系统10形成一密封腔，防止血液溢出。手柄壳20内还包括用于实现鞘管30调弯的调弯系统，此处不赘 述。
请参阅图2-5，本发明提供了一种密封系统10，如图3-4结合图5所示，密封系统10包括连接座11、密封组件12和轴向通道13，密封组件12位于连接座11内，连接座11与密封组件12配合形成与鞘管30连通的轴向通道13，轴向通道13可供其他器械自输送鞘100的近端向远端穿过，从而将其他器械输送至人体。密封组件12朝向远端凸起，且密封组件12的远端还包括位于远端的多边形切割面。
如图3和图5所示，连接座11自近端至远端依次包括压盖111、连接接头112、可替换接头113以及前端盖114。压盖111固定连接于连接接头112的近端从而将密封组件12压置于压盖111与连接接头112之间，前端盖114固定于连接接头112的远端。其中，压盖111的近端开设有第一通孔1111，前端盖114的远端开设有第二通孔1141，第一通孔1111和第二通孔1141之间形成有轴向通道13可供其他器械穿过，但是由于轴向通道13内设有硅胶材质的密封组件12，密封组件12上设有不完全开口的切痕，所以连接座11与密封组件12之间形成具有良好密封性的密封系统。
在本实施方式中，连接接头112为T型接头，如图3所示，T型接头的近端与压盖111通过螺纹固定连接，T型接头的远端与前端盖114通过螺纹固定连接，T型接头的底部接头连接有三通阀。可替换接头113对应T字底部接头的位置处开设有与底部接头连通的小孔1131，如图5所示，以便于手术过程中需要引流或打药等其他操作的实施。T型接头的底部接头通过软管14与三通阀15连接，如图5结合图1所示。输送鞘100穿入人体时，T型接头的底部接头通过三通阀15关闭以使密封系统10保持密封，如图5结合图1所示。
如图3结合图5所示，连接座11内靠近远端的一侧还设置有中空的可替换接头113，可替换接头113与连接接头112过盈配合从而将可替换接头113固定于连接接头112内。
如图4-5所示，鞘管30近端的侧面粘接于前端盖114的第二通孔1141内并与密封系统10的轴向通道13连通，由于鞘管30进入人体时受到沿轴向朝向近端的力，鞘管30的近端端面与可替换接头113远端端面相抵接，以使可替换 接头113沿轴向支撑鞘管30。
密封组件12位于连接座11内，密封组件12包括第一密封垫片121和第二密封垫片122，第二密封垫片122位于第一密封垫片121的远端。在本实施例中，如图6-8结合图5所示，第一密封垫片121为平面硅胶垫片，第一密封垫片121的近端中心区域朝向第一密封垫片121的远端方向凹陷形成有第一凹槽1211，第一密封垫片121的远端为平面，减小了第一密封垫片121中心区域的厚度，如图8所示，方便医疗器械推送，当医疗器械或者软头导丝初次穿过第一密封垫片121时，更易穿过。
如图9-11b结合图5所示，第二密封垫片122为拱形硅胶垫片，第二密封垫片122包括抵接部1221和缓冲部1222，如图11a所示，抵接部1221沿周向设置于缓冲部1222的近端侧，抵接部1221近端与第一密封垫片121的远端平面1212沿周向相抵接，抵接部1221的远端与T型接头的近端端面沿周向相抵接。
缓冲部1222为自抵接部1221沿周向的内侧向远端拱起延伸而形成的拱形结构，拱形结构与第一密封垫片121之间存在空间，缓冲部1222的近端包括绕轴向周向设置的支撑段12221和由多个多边形切割面相连的缓冲段12222，如图10结合图11a所示。其中，支撑段12221用于过渡连接缓冲段12222与抵接部1221，并沿轴向支撑缓冲段12222。缓冲部1222的远端端面包括朝向远端方向凸起的多边形切割面，且相邻的两个多边形切割面在远端侧形成的夹角大于180°，即相邻的两个多边形切割面之间的共用边朝向远端侧凸起，如图10-11a所示，以提高多边形切割面的支撑性。相对于圆滑弧面，由于多边形切割面将第二密封垫片122的远端面分割成了多个多边形切割面，当密封垫片受到血液冲击时，缓冲段12222的多个多边形切割面将冲击力分散于多个面，可以快速地卸掉血液的冲击力，防止第二密封垫片122远端表面瞬时受力太大卸力不及时而使第二密封垫片122坍塌或翻折，导致密封组件12的密封性不足而使血液溢出，同时，相邻的多边形切割面之间互相提供支撑，可进一步缓冲血流，防止坍塌或翻折。相邻的两个多边形切割面之间的共用边朝向远端侧凸起，以增加各多边形切割面之间的支撑性。
在本实现方式中，如图9-10所示，缓冲段12222的远端侧包括位于中心区域沿径向设置的六边形的连接面12222a和斜向切割面12222b，斜向切割面12222b用于连接支撑段12221与连接面12222a，且斜向切割面12222b均为三角形切割面，即多边形切割面包括一个沿径向设置于缓冲部中心区域的六边形的连接面12222a和多个三角形的斜向切割面12222b，由于三角形结构稳定，当被输送的器械回撤或第二密封垫片的远端面受到血液冲击时，三角形切割面可以提供稳定的支撑，以更稳定的卸掉冲击力或者防止翻折，从而提供较好的密封性，防止血液溢出。
手术过程中，需多次输送不同的器械，易导致作为平面垫片的第一密封垫片121翻折，而第二密封垫片122的缓冲段12222由于其远端分割成朝向远端凸起的多边形切割面，可以及时卸力，从而不易翻折或坍塌，可使密封系统继续保持良好的密封性。
在本实施例中，缓冲部1222的近端还包括光滑的圆拱形面，当第二密封垫片122受到血液冲击时，拱形可以更快达到卸力，以保证密封组件12的密封性，防止漏血，同时给第二拱形垫片的远端面提供一定的支撑性，防止翻折；第二密封垫片122的近端设置为光滑的圆拱形面或者半球面，减少第二密封垫片122最中心区域(对应连接面设置切痕处)的厚度，使得医疗器械可以沿着输送鞘100推送时更容易、更省力，更易进入病症部位，从而缩短手术时间，减轻病人痛苦，提高手术功效。
在其他的实施方式中，如图11a-11b结合图9-10所示，第二密封垫片整体为拱形硅胶垫片，第二密封垫片的抵接部呈环形，缓冲部的近端为光滑的圆拱形面，定义缓冲部近端的圆拱形高度为H，定义抵接部的环形内直径为L，则，H与L满足：1/4≤H/L≤1。本实施例中，H/L＝1/2，即圆拱形呈半球形时，作为缓冲部的拱形部分的支撑力较好。当H/L＜1/4甚至是趋于0时缓冲部甚至可能无法起到支撑作用，从而降低第二密封垫片的密封效果，且第二密封垫片相当于平面垫片，此时第二密封垫片与平面的第一密封垫片贴合组成的密封组件增加了平面垫片的厚度使得密封组件难以穿刺当第二密封垫片的穿刺点(设置切痕处)沿轴向距抵接部的距离较远(H/L大于1时)时，缓冲部占第二密封垫 片整体的比例过大，抵接部难以固定压紧，撤出器械时，易使第二密封垫片的抵接部脱离固定位，且缓冲部由于沿轴向过长，连接面与抵接部的距离更远，抵接部和缓冲部对连接面沿轴向的支撑作用更小。
由于血液自远端向近端冲击第二密封垫片，定义第二密封垫片抵接部的厚度为d1，三角形切割面(斜向切割面)的厚度为d2，连接面的厚度为d3，则d1、d2、d3满足：d1＞d2＞d3，中心区域的连接面的最薄，器械穿过连接面时，方便推送和回撤；三角形切割面的厚度适中且大于连接面的厚度，使得在推送器械(穿刺连接面)时，三角形切割面可以给连接面(拱形的最顶部)提供更好的支撑力，即在推送器械(器械自近端向远端穿入)时，连接面向远端翻从而包裹器械，器械对连接面有向远端的牵扯力从而使得连接面向远端牵扯三角形切割面，由于三角形切割面厚度大于连接面厚度，三角形切割面可以给连接面提供一定的反作用力使得连接面更好的包裹器械，密封性更好，在回撤器械(器械自远端向近端撤出)时，多边形切割面给连接面提供支撑力防止连接面向近端翻折；抵接部作为拱形的基部设置的厚度最厚，可以给整体缓冲部提供稳定的支撑，从而给多边形切割面提供足够的支撑力，如图11b所示。密封组件12设有与轴向通道13连通的穿孔123，本实施例中，穿孔123包括设置在第一密封垫片121和第二密封垫片122中心区域不完全开口的切痕，可以满足在输送不同规格的输送器械时，仍然可以很好的包裹住输送器械的鞘芯、导丝或导管等器械，实现有效密封。
如图7结合图8所示，第一密封垫片121的切痕包括位于其远端平面1212的第一切割线1231和第二切割线1232，其中，第一切割线1231与第二切割线1232交叉，且交叉点处穿透第一密封垫片121。如图9结合图10所示，第二密封垫片122的切痕包括位于连接面12222a上的第三切割线1233和第四切割线1234，第三切割线1233与第四切割线1234交叉，且交叉点处穿透第二密封垫片122。由于密封组件12为两个硅胶垫片组成，则仅切割线交叉处具有穿透性的切痕可以保证密封系统10在自然状态下时，密封组件12可以封闭密封系统10的近端。在其他的实施方式中，位于远端的第二密封垫片122的切痕长度大于位于近端的第一密封垫片121的切痕长度，使得器械穿刺密封组件时，更方 便器械向远端推进，力度更轻，同时，近端的第一密封垫片的切痕长度更小，更便于进一步防漏。
为了达到更好的密封效果，第一密封垫片121的切痕与第二密封垫片122的切痕不在沿轴向上的同一平面内。本实现方式中，第一切割线1231与第二切割线1232交叉呈正“十”字型，如图6所示，第三切割线1233与第四切割线1234交叉呈“×”型，如图9所示，相对于一字型切口更易穿入，不会因为密封组件12为双层垫片而难以推送。即，二者沿轴向移动至同一径向平面时呈“米”字型，以使第一密封垫片121的切割线与第二密封垫片122的切割线不在沿轴向上的同一平面内，即从轴向方向看去，第一密封垫片121上的切割直线与第二密封垫片122上的切割直线不重叠。使第二密封垫片122远端受到血液冲击的位置沿轴向对应第一密封垫片121的位置上不具有切割线。第一密封垫片121与第二密封垫片122配合形成的密封组件12，其密封保障性更好，且切割线的设置使得密封组件12满足更易推入的同时依然保持良好的密封性。
以鞘芯200(待输送的器械)沿轴向通道穿入输送鞘100中为例，如图12-16所示，鞘芯200通过压盖111近端的第一通孔1111和密封组件12的切痕穿刺入(鞘芯200由近端向远端沿轴向移动)密封系统10内时，鞘芯200顺着第一密封垫片121和第二密封垫片122的切痕穿透的交叉处穿过，硅胶材质的垫片被穿刺后包裹住鞘芯200，如图15-16所示。当血流沿图15中的箭头方向c冲击第二密封垫片的远端端面时，由于此时第一密封垫片121和第二密封垫片122均紧紧包裹住鞘芯200，第二密封垫片122的远端设置有多边形切割面，可以快速卸掉血液的冲击力，防止第二密封垫片122远端表面瞬时受力太大卸力不及时而使第二密封垫片122坍塌或翻折，同时，各多边形切割面之间互相支撑，可以进一步缓冲血流，防止第二密封垫片122坍塌或者翻折，从而可以使密封系统在术中输送其他器械时仍然保持有效密封。
由于鞘芯200或其他器械沿输送鞘穿入后还需要回撤(鞘芯200由远端向近端沿轴向移动)，回撤时，由于缓冲部1222远端侧的多边形切割面凸向远端，各多边形切割面之间有较好的支撑，可以防止鞘芯200后撤带来的朝向近端的摩擦力使第二密封垫片122的缓冲部1222翻折，从而防止漏血，保障密封性， 有助于提高手术的安全性和成功率。由于垫片为硅胶材质，而第二密封垫片122与第一密封垫片121粘接，再一起用压盖111螺纹连接于连接接头112的近端，从而将密封组件12压合固定，当回撤器械时，现有技术中的密封垫片受力较大而导致垫片翻折较大时，还可能因密封垫片形变过大而导致垫片的固定部位脱离连接座并随器械被带出密封系统，本实施方式提供的第二密封垫片122，由于其远端的多边形切割面使得第二密封垫片122的缓冲部1222不易翻折，可以防止第二密封垫片122脱离于第一密封垫片121和T型接头的近端之间而被器械带出密封系统10，从而保障密封系统10的密封性。
本发明提供的密封系统，密封组件朝向远端凸起，且密封组件的远端包括多边形切割面，使得密封组件在遇到血液冲击时卸力及时，以避免由于血液冲力导致的翻折或坍塌，且多边形切割面之间提供支撑可以减少器械回撤导致的翻折，以保证密封系统的密封性。本发明提供的输送鞘，包括上述密封系统，使得密封组件在受血液冲击以及器械输送的过程中整体仍然保持良好的密封性，以防止手术中因血液冲击或器械来回输送导致的密封性不佳而引起的漏血，从而提高手术的安全性和成功率。
可以理解的是，本发明提供的密封系统还可以应用于其他的输送鞘中。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 一种密封系统，其特征在于，包括连接座以及位于所述连接座内的密封组件，所述密封组件朝向远端凸起，且所述密封组件的远端包括多边形切割面。
  2. 根据权利要求1所述的密封系统，其特征在于，所述多边形切割面包括三角形切割面。
  3. 根据权利要求2所述的密封系统，其特征在于，相邻的两个所述多边形切割面在远端侧形成的夹角大于180°。
  4. 根据权利要求1所述的密封系统，其特征在于，所述密封组件包括第一密封垫片和第二密封垫片，所述第二密封垫片位于所述第一密封垫片的远端，所述第一密封垫片包括与所述第二密封垫片抵接的远端平面，所述第二密封垫片包括抵接部以及自所述抵接部向远端拱起的缓冲部，所述抵接部与所述第一密封垫片的远端平面抵接，所述多边形切割面设于所述缓冲部的远端。
  5. 根据权利要求4所述的密封系统，其特征在于，所述密封系统形成有轴向通道，所述密封组件设有与所述轴向通道连通的穿孔，所述穿孔包括设置于所述第一密封垫片和所述第二密封垫片的切痕。
  6. 根据权利要求5所述的密封系统，其特征在于，所述第二密封垫片的切痕长度大于所述第一密封垫片的切痕长度。
  7. 根据权利要求5所述的密封系统，其特征在于，所述第一密封垫片的切痕包括位于所述远端平面的第一切割线和第二切割线，所述第一切割线与所述第二切割线交叉，且交叉点处穿透所述第一密封垫片。
  8. 根据权利要求5或7所述的密封系统，其特征在于，所述缓冲部包括沿径向设置的连接面，所述第二密封垫片的切痕包括位于所述连接面的第三切割线和第四切割线，所述第三切割线与所述第四切割线交叉，且交叉点处穿透所述第二密封垫片。
  9. 根据权利要求8所述的密封系统，其特征在于，所述第一密封垫片的切痕与所述第二密封垫片的切痕不在沿轴向上的同一平面内。
  10. 根据权利要求4所述的密封系统，其特征在于，所述缓冲部近端包括光滑的圆拱形面。
  11. 根据权利要求4所述的密封系统，其特征在于，所述第二密封垫片为 整体呈拱形的硅胶垫片，所述第二密封垫片的抵接部呈环形，所述缓冲部的近端为光滑的圆拱形面，定义所述缓冲部近端的圆拱形的高度为H，定义所述抵接部的环形内直径为L，则，H与L满足：1/4≤H/L≤1。
  12. 根据权利要求11所述的密封系统，其特征在于，H与L满足：H/L＝1/2。
  13. 根据权利要求4所述的密封系统，其特征在于，所述缓冲部包括一个连接面和多个斜向切割面，所述连接面位于所述缓冲部的远端侧中心区域，所述斜向切割面连接所述连接面与所述抵接部，定义所述第二密封垫片的抵接部的厚度为d1，定义所述斜向切割面的厚度为d2，定义所述连接面的厚度为d3，则d1、d2、d3满足，d1＞d2＞d3。
  14. 根据权利要求1所述的密封系统，其特征在于，所述连接座自近端至远端依次包括压盖、连接接头以及前端盖，所述压盖固定连接于所述连接接头的近端，所述前端盖固定连接于所述连接接头的远端，所述压盖的近端开设有第一通孔，所述前端盖的远端开设有第二通孔，所述第一通孔与所述第二通孔之间形成有轴向通道，所述连接座内靠近远端的一侧设有可替换接头，所述密封组件位于所述压盖与所述连接接头之间。
  15. 一种输送鞘，其特征在于，包括如权利要求1-14任意一项所述的密封系统以及与所述密封系统连通并向远端延伸的鞘管。
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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110152763A1 (en) * 2008-05-14 2011-06-23 Onset Medical Corporation Expandable iliac sheath and method of use
US20140171826A1 (en) * 2012-12-19 2014-06-19 Merit Medical Systems, Inc. Biopsy device and method of use
CN106037898A (zh) * 2016-08-02 2016-10-26 成都五义医疗科技有限公司 一种可整体内翻的穿刺器密封系统
CN106510774A (zh) * 2016-08-02 2017-03-22 成都五义医疗科技有限公司 一种含凹槽的多角的穿刺器密封膜
CN112717269A (zh) * 2021-01-07 2021-04-30 上海翰凌医疗器械有限公司 血管鞘装置、血管鞘装置与预扩张器的配合结构
CN112717263A (zh) * 2021-01-07 2021-04-30 上海翰凌医疗器械有限公司 一种预扩器、预扩器与血管鞘装置的配合结构
CN113521492A (zh) * 2021-06-11 2021-10-22 先健科技(深圳)有限公司 一种密封结构、输送鞘管及输送系统

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110152763A1 (en) * 2008-05-14 2011-06-23 Onset Medical Corporation Expandable iliac sheath and method of use
US20140171826A1 (en) * 2012-12-19 2014-06-19 Merit Medical Systems, Inc. Biopsy device and method of use
CN106037898A (zh) * 2016-08-02 2016-10-26 成都五义医疗科技有限公司 一种可整体内翻的穿刺器密封系统
CN106510774A (zh) * 2016-08-02 2017-03-22 成都五义医疗科技有限公司 一种含凹槽的多角的穿刺器密封膜
CN112717269A (zh) * 2021-01-07 2021-04-30 上海翰凌医疗器械有限公司 血管鞘装置、血管鞘装置与预扩张器的配合结构
CN112717263A (zh) * 2021-01-07 2021-04-30 上海翰凌医疗器械有限公司 一种预扩器、预扩器与血管鞘装置的配合结构
CN113521492A (zh) * 2021-06-11 2021-10-22 先健科技(深圳)有限公司 一种密封结构、输送鞘管及输送系统

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