CN113974775A - Sheath sealing device and thrombus suction system comprising same - Google Patents
Sheath sealing device and thrombus suction system comprising same Download PDFInfo
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- CN113974775A CN113974775A CN202111360460.1A CN202111360460A CN113974775A CN 113974775 A CN113974775 A CN 113974775A CN 202111360460 A CN202111360460 A CN 202111360460A CN 113974775 A CN113974775 A CN 113974775A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
- A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
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- Orthopedic Medicine & Surgery (AREA)
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- General Health & Medical Sciences (AREA)
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- Media Introduction/Drainage Providing Device (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
The invention discloses a sheath tube sealing device. It includes: the flexible infusion device comprises an elastic handle, a flexible membrane tube and an infusion assembly; the elastic handle includes: the far end seat, the near end seat and the elastic piece; the far end seat, the near end seat and the elastic piece are fixedly connected into an integrated elastic cylindrical valve shell; the inner wall of the flexible membrane tube is smooth and penetrates through the cylindrical valve shell, the far end of the flexible membrane tube is in sealing connection with the far end seat, and the near end of the flexible membrane tube is in sealing connection with the near end seat, so that a sealing space is formed between the flexible membrane tube and the elastic cylindrical valve shell; the inner wall of the flexible membrane tube encloses a sealing channel of the sealing device; the transfusion component is connected with the elastic cylindrical valve shell and is used for adjusting the sealing pressure in the sealing space; under the action of sealing pressure, the flexible membrane tube can circumferentially contract and relax, so that the flexible membrane tube can circumferentially contract to close the sealing channel or expand to form the sealing channel with the shape and size adaptive to the guiding instrument, the sealing performance is good, the operation is convenient, and the operation resistance is small; and the elastic piece can deform along with the contraction and the relaxation of the flexible membrane tube.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a sheath tube sealing device and a thrombus suction system comprising the same.
Background
At present, the vascular interventional operation is gradually popularized in medical science. Since it is often necessary to pass catheters or instruments of different diameter sizes within the lumen of a vascular access sheath during an operation, in order to ensure that a patient does not lose significant amounts of blood due to such an operation, a sealing valve structure is required at the handle of the sheath to reduce non-clinically expected blood loss.
However, the existing sealing valve generally adopts a silica gel sealing ring, and one of the main disadvantages is that the friction coefficient is high, the friction resistance is large in the pushing process of a catheter or an instrument, and the operation hand feeling of the operation is seriously influenced; secondly, the silica gel sealing ring is usually designed according to the largest conduit and instrument which can pass through, when the handle needs to pass through conduits or instruments with different shapes or smaller sizes, the mouth part of the sealing ring needs to be changed by extruding the silica gel sealing ring to deform so as to adapt to the appearance and size of the instrument, therefore, the existing sealing valve is not only complicated to operate, but also has poor sealing effect.
Disclosure of Invention
The embodiment of the invention aims to provide a sheath sealing device and a thrombus suction system comprising the same, and solves the problems of large passing resistance, complex operation and poor sealing effect of the conventional sheath sealing device.
In order to solve the above technical problem, an embodiment of the present invention provides a sheath sealing device, including: a resilient handle, comprising: the far end seat, the near end seat and the elastic piece; the far end seat, the near end seat and the elastic piece are fixedly connected into an integrated elastic cylindrical valve shell; the flexible membrane tube is of a tubular structure with a smooth inner wall and penetrates through the elastic cylindrical valve shell, the distal end of the flexible membrane tube is connected with the distal end seat in a sealing mode, and the proximal end of the flexible membrane tube is connected with the proximal end seat in a sealing mode, so that a sealing space is formed between the elastic cylindrical valve shell and the flexible membrane tube; the inner wall of the flexible membrane tube is enclosed into a sealing channel of the sealing device; the sheath tube sealing device also comprises an infusion assembly, and the infusion assembly is connected with the elastic cylindrical valve shell and is used for adjusting the sealing pressure in the sealing space; under the action of the sealing pressure, the flexible membrane tube can circumferentially contract and expand, so that the flexible membrane tube can circumferentially contract to close the sealing channel or circumferentially expand to form the sealing channel adaptive to the shape and the size of an introduction instrument; and the elastic part can generate radial elastic deformation along with the contraction and the relaxation of the flexible membrane tube.
In addition, the sheath sealing device further includes: a distal ram assembly, comprising: the sheath pipe joint, the said sheath pipe joint near end has distal end insertion part extending axially; the distal end insertion part is inserted into the distal end of the flexible membrane tube, and a distal end sealing ring is clamped between the outer periphery of the distal end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing so as to enable the distal end of the flexible membrane tube to be in sealing connection with the distal end of the elastic cylindrical valve casing; the proximal end pressure head is of a tubular structure, and the distal end of the proximal end pressure head is provided with a proximal end inserting part extending along the axial direction; the near-end insertion part is inserted into the near end of the flexible membrane tube, and a near-end sealing ring is clamped between the periphery of the near end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing, so that the near end of the flexible membrane tube is in sealing connection with the near end of the elastic handle.
In addition, the distal insertion portion and the proximal insertion portion are each provided with a guide portion.
Additionally, the distal ram assembly further comprises: a distal annular boss provided between the distal insertion portion and the sheath body; the proximal end pressure head further comprises a proximal end annular boss arranged at the proximal end of the proximal end insertion part; a far-end annular groove matched with the far-end annular boss is formed in the far-end inner wall of the far-end seat of the elastic handle; the sheath pipe joint and the distal seat are fixedly connected through the distal annular boss and the distal annular groove; the near-end inner wall of the near-end seat of the elastic handle is provided with a near-end annular groove matched with the near-end annular boss, and the near-end pressure head and the near-end seat are fixedly connected through the near-end annular boss and the near-end annular groove.
In addition, the far-end seat is provided with an infusion interface connected with the infusion assembly, the far end of the elastic piece is provided with an infusion hole communicated with the infusion interface, and the far-end sealing ring is provided with a sealing ring channel communicated with the infusion hole; and an avoidance pit corresponding to the sealing ring channel is arranged on the far-end inserting part and is communicated with the sealing space.
In addition, the far-end seat is provided with a far-end rubber coating structure, and the near-end seat is provided with a near-end rubber coating structure; the elastic piece is in integral rubber-coating connection with the distal seat through the distal rubber-coating structure; the elastic piece is connected with the near-end seat in an integrated rubber coating mode through the near-end rubber coating structure.
In addition, the far-end rubber coating structure and/or the near-end rubber coating structure both adopt spoke-shaped rubber coating structures; the spoke-like encapsulated structure comprises: the annular outer seat body, the annular inner seat body coaxially arranged in the annular outer seat body and a plurality of connecting rubber-coated ribs circumferentially arranged between the annular outer seat body and the annular inner seat body at intervals; glue filling gaps are formed among the annular outer seat body, the annular inner seat body and the plurality of connecting rubber-coated ribs; part of colloid at two ends of the elastic piece is melted and filled and solidified in the glue filling gap; the annular outer seat body and the annular inner seat body of the far-end rubber coating structure are respectively provided with a channel for communicating the infusion assembly and the sealing space.
In addition, the elastic piece is of a waist-contracting cylindrical structure with two large ends and a small middle.
In addition, the flexible film tube includes an outer layer and an inner layer having a smooth sealing surface, the inner layer and the outer layer forming a flexible composite film tube structure.
An embodiment of the present invention further provides a thrombus aspiration system, including: the sheath sealing device as described above.
According to the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:
according to the sheath tube sealing device disclosed by the embodiment of the invention, the elastic handle and the flexible membrane tube are matched to form a sealing space, the inner wall of the flexible membrane tube encloses a sealing channel of the sealing device, the flexible membrane tube can circumferentially contract and expand under the action of sealing pressure so that the flexible membrane tube can circumferentially contract to close the sealing channel, or circumferentially expand to form the sealing channel adaptive to the shape and size of a guide-in instrument, the elastic piece can radially and elastically deform along with the contraction and expansion of the flexible membrane tube, the sealing pressure is adaptively adjusted, manual adjustment is not needed, the operation is simple, the sealing effect is stable and good, and the reduction of blood loss is facilitated. And the inner wall of the flexible membrane tube is smooth, so that the frictional resistance of the instrument passing through the flexible membrane tube can be greatly reduced, and the operation accuracy and flexibility can be improved.
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 introduced below, it is understood that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 is a schematic structural view of a thrombus aspiration system provided with a sheath sealing device according to an embodiment of the present invention;
FIG. 2 is an exploded view of the thrombus aspiration system shown in FIG. 1;
fig. 3 is a schematic structural diagram of a flexible membrane tube of a sheath tube sealing device according to an embodiment of the present invention;
fig. 4 is a partial cross-sectional view of a flexible handle of a sheath sealing device provided in accordance with an embodiment of the present invention;
fig. 5 is a schematic structural diagram of a distal end ram assembly of the sheath sealing device according to an embodiment of the present invention;
FIGS. 6a and 6b are schematic structural views of a distal seat of a flexible handle in a sheath sealing device according to an embodiment of the present invention;
fig. 7a and 7b are schematic structural views of a proximal seat of an elastic handle in a sheath sealing device according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it will be appreciated by those of ordinary skill in the art that numerous technical details are set forth in order to provide a better understanding of the present invention in its various embodiments. However, the technical solution claimed in the present invention can be implemented without these technical details and various changes and modifications based on the following embodiments.
Unless otherwise stated, reference to proximal and distal ends in the present invention shall have the same meaning in the orientation, i.e. in the use state, the distal end is the end distal from the operator, the proximal end is the end proximal to the operator, and the operator controls the sheath sealing means at the proximal end.
Referring to fig. 1 to 2, an embodiment of the present invention provides a sheath sealing device, which is disposed at a proximal end of a sheath of the thrombus aspiration system shown in fig. 1 and is used for sealing the sheath. It should be noted that the sheath sealing device is applicable to other scenes where the sheath and the instruments passing through the sheath need to be sealed, and the sheath on which the sheath sealing device can be disposed is not particularly limited. This sheath pipe sealing device includes: an elastic handle 2, a flexible membrane tube 4 and an infusion set.
Referring to fig. 4, the elastic handle 2 includes: a distal seat 21, a proximal seat 24 and a resilient member 25. The distal seat 21, the proximal seat 24 and the resilient member 25 are fixedly connected as a one-piece resilient cylindrical valve housing. The far end seat 21 and the near end seat 24 are respectively used for connecting the sheath tube sealing device with the sheath tube, and are combined with the elastic piece 25 into a whole to be used as a part of the sealing valve body, so that the manufacturing process is simple, and the structure is firm.
Flexible membrane pipe 4 is the smooth tubular structure of inner wall, and flexible membrane pipe 4 wears to locate in the elasticity tube-shape valve casing, the distal end and the distal end seat 21 sealing connection of flexible membrane pipe 4, and the near-end seat 24 sealing connection of flexible membrane pipe 4 to form confined space between messenger's elasticity tube-shape valve casing and the flexible membrane pipe 4. The inner wall of the flexible membrane tube 4 encloses a sealing channel of the sealing device.
The infusion set is connected to the resilient tubular valve housing and is adapted to regulate the sealing pressure in the sealed space. The pressure in the sealed space can be adjusted by changing the amount of fluid (gas or liquid) in the sealed space through the infusion set, thereby changing the sealing pressure acting on the flexible membrane tube 4.
Under the action of the sealing pressure, the flexible membrane tube 4 can circumferentially contract and relax, so that the flexible membrane tube 4 can circumferentially contract to close the sealing channel or circumferentially expand to the sealing channel adaptive to the shape and size of the lead-in instrument, and the elastic member 25 can radially and elastically deform along with the contraction and relaxation of the flexible membrane tube 4. Namely, the flexible membrane tube 4 is made of soft materials and can circumferentially contract and relax, the flexible membrane tube 4 realizes different sizes of the sealing channels through circumferential contraction and relaxation rather than self elastic deformation, when no instrument needs to be introduced into the sealing channels, the flexible membrane tube 4 can circumferentially contract under the action of sealing pressure through folding and the like due to self flexible structures, and the sealing channels can be closed; when an instrument with a certain shape and size needs to be guided into the sealing channel, the flexible membrane tube 4 can be expanded (unfolded) circumferentially and form the sealing channel matched with the shape and size of the instrument under the action of pressure, and good sealing is realized. The elastic member 25 can contract radially with the contraction of the flexible membrane tube 4 and expand radially with the expansion, that is, the elastic member 25 can contract with the decrease of the sealing passage and expand with the increase of the sealing passage, so that the elastic deformation of the elastic member 25 can adaptively adjust the sealing pressure when the sealing passages with different sizes are formed, thereby maintaining good and stable sealing performance. The resilient member 25 is capable of contracting or expanding radially to form the desired channel size for the instrument, and thus the range of radial deformation of the resilient member 25 can affect the range of dimensions of the sealing channel. Meanwhile, the radial deformation of the elastic part 25 can also enable the sealing pressure of instruments with different sizes to be close, so that a good sealing effect is always kept. For example, when the outer diameters of the instruments passing through the sheath sealing device respectively for a plurality of times are 5mm and 2mm, the elastic member 25 can radially contract, so that the diameter of the sealing channel is changed from 5mm to 2 mm. Meanwhile, the pressure in the sealed space is relatively close, so that the sealing force applied to instruments of different sizes is relatively consistent, and the better sealing effect can be kept.
With continued reference to fig. 4, the sheath sealing device further includes a distal ram assembly 1 and a proximal ram 3.
The far-end pressure head assembly 1 is used as a suction assembly arranged at the far end of the elastic handle 2 in the thrombus suction system, and is matched with the far-end seat 21 of the elastic handle 2 and the far end of the flexible membrane tube 4 to realize the sealing connection between the far end of the flexible membrane tube 4 and the far-end seat 21 while being connected with the far-end seat 21 of the elastic handle 2 and the far end of the flexible membrane tube 4. A proximal indenter 3 is provided at the proximal end of the resilient handle 2, which also serves as a proximal structure for the aspiration sheath of the thrombus aspiration system. The near-end pressure head 3 is fixedly connected with the near-end seat 24 of the elastic handle 2, is connected with the near end of the flexible membrane tube 4, and is matched with the near-end seat 24 to realize the sealing connection between the near end of the flexible membrane tube 4 and the near-end seat 24.
Referring to fig. 2, 4 and 5, the distal ram assembly 1 includes: the sheath joint 12 and the proximal end of the sheath joint 12 are provided with a distal insertion part 14 extending along the axial direction and a distal annular boss 13 arranged between the sheath joint 12 and the distal insertion part 14. The sheath joint 12 is of a tubular structure. The distal end insertion portion 14 is inserted into the distal end of the flexible film tube 4, and a distal end sealing ring 251 is interposed between the outer periphery of the distal end of the flexible film tube 4 and the inner wall of the elastic cylindrical valve housing, so that the distal end of the flexible film tube 4 and the distal end of the elastic handle 2 are connected in a sealing manner. The distal inner wall of the distal seat 21 of the resilient handle 2 is provided with a distal annular groove 251 cooperating with the distal annular boss 13. The distal ram assembly 1 and the distal seat 21 are fixedly connected by the distal annular boss 13 and the distal annular groove 212. Thereby through inserting distal end portion 14 in flexible membrane pipe 4 distal end to with distal end sealing ring 251 mutual extrusion fit can make flexible membrane pipe 4 distal end and elasticity tube-shape valve casing distal end between realize sealed, simultaneously, through the cooperation of distal end annular boss 13 with the distal end annular groove 212 of distal end seat 21, can realize that distal end pressure head subassembly 1 is fixed with being connected of elastic handle 2, also can assist glue fixed simultaneously, the assembly step is simple and easy operation.
Further, the proximal end of the distal insertion portion 14 is provided with a guide portion 15. The proximal guide portion 15 of the distal insertion portion 14 has a tapered structure, the diameter of which gradually decreases from the distal end to the proximal end, so as to facilitate the insertion of the distal insertion portion 14 into the flexible membrane tube 5.
Referring to fig. 2, the proximal indenter 3 has a tubular structure, and a distal end thereof is provided with a proximal insertion portion 32 extending in the axial direction and a proximal annular projection 31 provided at a proximal end of the proximal insertion portion 32. The proximal insertion portion 32 is inserted into the proximal end of the flexible film tube 4, and a proximal seal ring 252 is interposed between the outer periphery of the proximal end of the flexible film tube 4 and the inner wall of the elastic cylindrical valve housing, so that the proximal end of the flexible film tube 4 and the proximal end of the elastic cylindrical valve housing are sealingly connected. The proximal end inner wall of the proximal end seat 24 of the elastic handle 2 is provided with a proximal end annular groove 241 matched with the proximal end annular boss 31, and the proximal end pressure head 3 and the proximal end seat 24 are fixedly connected through the proximal end annular boss 31 and the proximal end annular groove 241. Thereby through inserting near-end insertion portion 32 to flexible membrane pipe 4 near-end in to with near-end sealing ring 252 mutual extrusion fit can make flexible membrane pipe 4 near-end and elasticity tube-shape valve casing near-end between realize sealed, simultaneously, through near-end annular boss 31 of near-end pressure head 3 and near-end annular recess 241 cooperation of near-end seat 24, can realize near-end pressure head 3 and elastic handle 2's being connected fixedly, also can assist glue fixed simultaneously, the assembly step is simple and easy to operate.
Further, the distal end of the proximal insertion portion 32 is provided with a guide portion 33. The guide portion 33 at the distal end of the proximal insertion portion 32 is also of a constricted structure, which facilitates the insertion of the proximal insertion portion 32 into the flexible membrane tube 4.
It should be noted that the flexible membrane tube 4 may be connected with the elastic cylindrical valve body in a sealing manner by other means. The connection structure of the sheath tube and the sheath tube sealing device is not limited to the matching mode of the boss and the clamping groove in the embodiment.
The far-end seat 21 is provided with a far-end rubber coating structure, the elastic piece 25 is connected with the far-end seat 21 in an integrated rubber coating mode through the far-end rubber coating structure, and the near-end seat 24 is provided with a near-end rubber coating structure. The elastic element 25 is integrally encapsulated with the proximal seat 24 by a proximal encapsulation structure, so that the elastic element 25 is firmly bonded to the distal seat 21 and the proximal seat 24.
Referring to fig. 6a and 6b, the distal encapsulation structure is a spoke-like encapsulation structure. The spoke-like encapsulated structure comprises: the annular outer seat body 211, the annular inner seat body 214 coaxially arranged in the annular outer seat body 211 and a plurality of connecting rubber-covered ribs 215 arranged between the annular outer seat body 211 and the annular inner seat body 214 at intervals along the circumferential direction. The annular outer seat body 211, the annular inner seat body 214 and the plurality of connecting rubber-covered ribs 215 form a rubber-filled gap, and the rubber at the distal end part of the elastic element 25 is melted, filled and solidified in the rubber-filled gap, so that the distal end of the elastic element 25 is firmly combined with the distal seat 21 into a whole.
It should be noted that the annular outer seat body 211 of the distal seat 21 is provided with a through hole 216, and the annular inner seat body is provided with an opening 217, which are respectively used as a channel structure to connect with the perfusion hole 253 of the elastic member 25 to form a perfusion channel.
Referring to fig. 4, 5, 6a and 6b, the distal seat 21 is provided with an infusion port 213 connected to an infusion set, the infusion set includes an infusion tube 22 and a two-way sealing valve 24, two ends of the infusion tube 22 are respectively connected to the infusion structure 213 and the two-way sealing valve 24, and the other end of the two-way sealing valve can be connected to a syringe or the like. The distal end of the elastic member 25 is provided with a filling hole 253 communicated with the transfusion connector 213. The distal sealing ring 251 is provided with a sealing ring channel communicating with the infusion orifice 253. The distal end insertion portion 14 is provided with an avoidance recess 16 corresponding to the seal ring passage, and the avoidance recess 16 communicates with the sealed space. The infusion interface 213, the filling hole 253, the channel on the distal seat 21 and the sealing ring channel are sequentially communicated to form a filling channel, and the sealing ring channel is opposite to the avoidance pit 16, so that the sealing space is communicated through the avoidance pit 16.
Referring to fig. 7a and 7b, the proximal encapsulation structure also employs a spoke-like encapsulation structure. The spoke-like encapsulated structure comprises: the annular outer base body 241, the annular inner base body 243 coaxially arranged in the annular outer base body 241, and a plurality of connecting rubber-covered ribs 244 arranged between the annular outer base body 241 and the annular inner base body 243 at intervals along the circumferential direction. Glue filling gaps are formed among the annular outer seat body 241, the annular inner seat body 243 and the plurality of connecting glue-wrapping ribs 244. The glue at the proximal part of the elastic element 25 is melted and solidified in the glue filling gap, so that the proximal end of the elastic element 25 is firmly combined with the proximal seat 24.
It should be noted that, the present embodiment does not specifically limit the encapsulation structure of the proximal end and the distal end, as long as the elastic element can be firmly encapsulated with the distal seat and the proximal seat.
The distal seat 21 and the proximal seat 24 may be made of a non-elastomeric material, preferably PP, PC, ABS, etc. The elastic member 25 may be made of an elastomer material, preferably silica gel, rubber, TPU, etc., and the three are firmly integrated by a rubber coating process. The elastic member 25 may be a waisted tubular structure with two large ends and a small middle, which not only facilitates radial deformation to form a desired size of the sealing passage, but also serves as an operating handle for easy gripping.
The flexible film tube 4 is a hose that is impermeable to water or gas and has a low elongation in both the circumferential direction and the axial direction. As shown in fig. 3, the flexible membrane tube 4 may include an outer layer 42 and an inner layer 41 having a smooth sealing surface. Inner layer 41 and outer layer 42 form a flexible composite membrane tube structure. The sealing surface is the surface of the inner layer 41 facing the instrument passing through the sheath seal. The inner layer (41) may be made of a soft, low-elasticity material, such as EPTFE, and may be made of other suitable polymer materials, and may have a clear water coating on its inner surface. Outer layer 42 may be formed from a flexible polymeric material, preferably FEP or an elastomeric material such as TPU. And its length should be not less than the distance between the end faces of the guide portion 16 on the distal insertion portion 14 and the guide portion 33 of the proximal insertion portion 32.
Embodiments of the present invention further provide a thrombus aspiration system, including the sheath sealing device according to the foregoing embodiments. The sheath sealing device is used for sealing instruments passing through the sheath sealing device and can also close or open the sheath. With continued reference to fig. 1 and 2, the distal tip assembly 1 of the sheath sealing device also serves as a distal aspiration assembly of the thrombus aspiration system, and the proximal tip 3 serves as a proximal structure of the thrombus aspiration system. Distal end pressure head subassembly 1 can also include that the sheath body 11 of sheath union coupling 12 distal end is connected to the near-end, and the distal end of 11 of sheath body is equipped with suction positioning support 17, and suction positioning support 17 is used for making sheath body 11 house in the blood vessel center, and can enlarge the thrombus suction passageway of sheath pipe to improve thrombus suction efficiency, and can prevent that the sheath from damaging the vascular wall. The distal ram assembly may further include a suction assembly 18 coupled to the circumferential wall of the sheath adapter 12 to allow side suction to be achieved through the suction assembly 18 when the suction passage at the proximal end of the sheath is closed by the sheath seal. Axial suction can be achieved by closing the lateral suction channel and opening the sheath sealing means at the proximal end of the sheath.
The working principle of the sheath tube sealing device provided by the embodiment of the invention is as follows: liquid or gas is filled in the sealed space, so that certain sealing pressure is achieved in the sealed space, when no instrument is introduced into the sealing device, the flexible membrane tube 4 can close the sealing channel under the action of the sealing pressure, and the aim of sealing and cutting off the sheath tube channel is achieved. When instruments with different shapes and sizes need to be led in, the flexible membrane tube 4 can be circumferentially unfolded, and meanwhile, the elastic handle can be automatically deformed under the action of fluid pressure in the elastic handle 2 to form a sealing channel adaptive to the instruments with different shapes and sizes in a self-adaptive mode and has good sealing performance.
Based on the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:
according to the sheath tube sealing device disclosed by the embodiment of the invention, the elastic handle and the flexible membrane tube are matched to form a sealing space, the inner wall of the flexible membrane tube encloses a sealing channel of the sealing device, the flexible membrane tube can circumferentially contract and expand under the action of sealing pressure, so that the flexible membrane tube can circumferentially contract to close the sealing channel or circumferentially expand to form the sealing channel adaptive to the shape and size of a guiding instrument, the elastic piece can radially and elastically deform along with the contraction and expansion of the flexible membrane tube, the sealing pressure is adaptively adjusted, manual adjustment is not needed, the operation is simple, the sealing effect is stable and good, and the reduction of blood loss is facilitated. And the inner wall of the flexible membrane tube is smooth, so that the frictional resistance of the instrument passing through the flexible membrane tube can be greatly reduced, and the operation accuracy and flexibility can be improved.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the invention, and that various changes in form and details may be made therein without departing from the spirit and scope of the invention in practice.
Claims (10)
1. A sheath sealing device, comprising:
a resilient handle, comprising: the far end seat, the near end seat and the elastic piece; the far end seat, the near end seat and the elastic piece are fixedly connected into an integrated elastic cylindrical valve shell;
the flexible membrane tube is of a tubular structure with a smooth inner wall and penetrates through the elastic cylindrical valve shell, the distal end of the flexible membrane tube is connected with the distal end seat in a sealing mode, and the proximal end of the flexible membrane tube is connected with the proximal end seat in a sealing mode, so that a sealing space is formed between the elastic cylindrical valve shell and the flexible membrane tube; the inner wall of the flexible membrane tube is enclosed into a sealing channel of the sealing device;
the sheath tube sealing device also comprises an infusion assembly which is connected with the elastic cylindrical valve shell and is used for adjusting the sealing pressure in the sealing space; under the effect of the sealing pressure, the flexible membrane tube can circumferentially contract and relax, so that the flexible membrane tube can circumferentially contract to close the sealing channel, or circumferentially expand to form the sealing channel adaptive to the shape and the size of an introducing instrument, and the elastic part can radially and elastically deform along with the contraction and the relaxation of the flexible membrane tube.
2. The sheath seal apparatus of claim 1, further comprising:
a distal ram assembly, comprising: the sheath pipe joint, the said sheath pipe joint near end has distal end insertion part extending axially; the distal end insertion part is inserted into the distal end of the flexible membrane tube, and a distal end sealing ring is clamped between the outer periphery of the distal end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing so as to enable the distal end of the flexible membrane tube to be in sealing connection with the distal end of the elastic cylindrical valve casing;
the proximal end pressure head is of a tubular structure, and the distal end of the proximal end pressure head is provided with a proximal end inserting part extending along the axial direction; the near-end insertion part is inserted into the near end of the flexible membrane tube, and a near-end sealing ring is clamped between the periphery of the near end of the flexible membrane tube and the inner wall of the elastic cylindrical valve casing, so that the near end of the flexible membrane tube is in sealing connection with the near end of the elastic handle.
3. The sheath seal of claim 2, wherein the distal insertion portion and the proximal insertion portion are each provided with a guide portion.
4. The sheath seal apparatus of claim 2, wherein the distal ram assembly further comprises: a distal annular boss provided between the distal insertion portion and the sheath body; the proximal end pressure head further comprises a proximal end annular boss arranged at the proximal end of the proximal end insertion part;
a far-end annular groove matched with the far-end annular boss is formed in the far-end inner wall of the far-end seat of the elastic handle; the sheath pipe joint and the distal seat are fixedly connected through the distal annular boss and the distal annular groove;
the near-end inner wall of the near-end seat of the elastic handle is provided with a near-end annular groove matched with the near-end annular boss, and the near-end pressure head and the near-end seat are fixedly connected through the near-end annular boss and the near-end annular groove.
5. The sheath sealing device according to claim 2, wherein the distal seat is provided with an infusion port connected to the infusion set, the distal end of the elastic member is provided with an infusion hole communicated with the infusion port, and the distal sealing ring is provided with a sealing ring channel communicated with the infusion hole; and an avoidance pit corresponding to the sealing ring channel is arranged on the far-end inserting part and is communicated with the sealing space.
6. The sheath sealing device of claim 1, wherein the distal seat is provided with a distal encapsulation structure and the proximal seat is provided with a proximal encapsulation structure;
the elastic piece is in integral rubber-coating connection with the distal seat through the distal rubber-coating structure;
the elastic piece is connected with the near-end seat in an integrated rubber coating mode through the near-end rubber coating structure.
7. The sheath sealing device of claim 6, wherein the distal end overmold structure and/or the proximal end overmold structure each employ a spoke-like overmold structure;
the spoke-like encapsulated structure comprises: the annular outer seat body, the annular inner seat body coaxially arranged in the annular outer seat body and a plurality of connecting rubber-coated ribs circumferentially arranged between the annular outer seat body and the annular inner seat body at intervals;
glue filling gaps are formed among the annular outer seat body, the annular inner seat body and the plurality of connecting rubber-coated ribs;
part of colloid at two ends of the elastic piece is melted and filled and solidified in the glue filling gap;
the annular outer seat body and the annular inner seat body of the far-end rubber coating structure are respectively provided with a channel for communicating the infusion assembly and the sealing space.
8. The sheath sealing device according to claim 1, wherein the elastic member has a waisted cylindrical structure with large ends and small middle.
9. The sheath seal of claim 1, wherein the flexible membrane tube includes an outer layer and an inner layer having a smooth sealing surface, the inner layer and the outer layer forming a flexible composite membrane tube structure.
10. A thrombus aspiration system, comprising: the sheath sealing device of any one of claims 1-9.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111360460.1A CN113974775B (en) | 2021-11-17 | 2021-11-17 | Sheath sealing device and thrombus aspiration system comprising same |
| PCT/CN2021/138213 WO2023087458A1 (en) | 2021-11-17 | 2021-12-15 | Sheath sealing apparatus and thrombus aspiration system comprising same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111360460.1A CN113974775B (en) | 2021-11-17 | 2021-11-17 | Sheath sealing device and thrombus aspiration system comprising same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN113974775A true CN113974775A (en) | 2022-01-28 |
| CN113974775B CN113974775B (en) | 2023-05-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111360460.1A Active CN113974775B (en) | 2021-11-17 | 2021-11-17 | Sheath sealing device and thrombus aspiration system comprising same |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN113974775B (en) |
| WO (1) | WO2023087458A1 (en) |
Cited By (1)
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|---|---|---|---|---|
| CN115153746A (en) * | 2022-06-21 | 2022-10-11 | 上海玮琅医疗科技有限公司 | Conduit joint |
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Also Published As
| Publication number | Publication date |
|---|---|
| WO2023087458A1 (en) | 2023-05-25 |
| CN113974775B (en) | 2023-05-16 |
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