Utility model content
In view of problem possessed by previous membrane-repturing device, the utility model aim be to provide one kind can carry out rupture of membranes,
The membrane-repturing device of reaming, to make up the deficiency of intravascular rupture of membranes utensil at this stage.
To achieve the goals above, the utility model provides a kind of for carrying out the rupture of membranes of rupture of membranes in patient vessel
Device, comprising: operating mechanism, for carrying out rupture of membranes operation;Reaming component, the reaming component are set along the axial direction of the operating mechanism
It is placed in one end of the operating mechanism;And rupture of membranes syringe needle, the rupture of membranes syringe needle is along the operating mechanism axially adjacent to the expansion
The distal end of hole component is arranged, wherein the rupture of membranes syringe needle is arranged to broken to be formed on film by the operation of the operating mechanism
Fenestra, the reaming component are arranged to expand the rupture of membranes by the operation of the operating mechanism after forming the rupture of membranes hole
The aperture in hole.
In some embodiments, membrane-repturing device further include: positioning element, axis of the positioning element along the operating mechanism
It is arranged to the proximal end close to the reaming component, for fixing the position of the membrane-repturing device, it is described fixed that the operating mechanism passes through
Position components interior is removable.
In some embodiments, reaming component include the sacculus that can be expanded and shrink, the sacculus that is set in sacculus
Conduit and the cutting member for cutting film for being set to sacculus outer surface.Wherein, the cutting member is made of metal material, described
Cutting member can be to be evenly distributed on the sacculus outer surface and at least two knives being axially arranged along the operating mechanism
Piece is perhaps uniformly wound on the silk or other forms of the sacculus outer surface.The sacculus is made of high molecular material, institute
It states high molecular material to be selected from: nylon, polyethylene terephthalate, polytetrafluoroethylene (PTFE), polyurethane, polyvinyl chloride.The ball
Ductus bursae is metal tube, metal winding tube, macromolecule woven tube, hypotube or other conduits with axial stiffness.It is described broken
Film syringe needle is made of metal or other hard materials.
In some embodiments, rupture of membranes syringe needle is fixed on the distal end of foley's tube, and foley's tube is fixed on operating mechanism
Distal end.The rupture of membranes syringe needle and the foley's tube be it is hollow, so that seal wire passes through.The length of the rupture of membranes syringe needle is 2-
30mm。
In some embodiments, maximum outside diameter when balloon inflation is 5-40mm.After balloon inflation, the cutting member
The height of the outer surface of the sacculus of the prominent expansion is 0.1-1.5mm.
In some embodiments, the positioning element includes the locating support that can be expanded and shrink.Wherein, described fixed
Position bracket is braided support, cutting support or sacculus.
The utility model has following advantageous effects compared with the existing technology:
The membrane-repturing device of the utility model includes simultaneously rupture of membranes syringe needle and reaming component, and the design of such integral type can be realized
Quick rupture of membranes and reaming, reaming component can continue follow-up and be expanded to rupture of membranes hole in order to plant later after rupture of membranes syringe needle rupture of membranes
Enter bracket or import larger sized sacculus, the operating process of entire rupture of membranes and reaming does not need replacement tool, avoids a variety of devices
Fault caused by tool alternating and operating time are too long.
By the combination of foley's tube and rupture of membranes syringe needle, so that the distal end of membrane-repturing device has stronger puncture force and support
Property, convenient for passing through harder tissue membrane barriers and bracket overlay film.Meanwhile hollow rupture of membranes syringe needle can pass through seal wire, have
Preferable traceability.
By the way that positioning element is arranged, the accurate positionin of membrane-repturing device can be realized, it, can be in conjunction with scale and locking mechanism etc.
It further ensures and is accurately positioned.Make rupture of membranes syringe needle and/or reaming component and/or positioning element etc. that there is good developability, energy
It is enough to realize visually accurate rupture of membranes.
The membrane-repturing device of the utility model can be used for Endovascular operation, such as can be used for opening for intracavitary diaphragm and overlay film frame
Hole has good flexibility and blood vessel passability, is suitable for a variety of demands, positions in combination with distal end development, proximal end scale
Etc. the rupture of membranes for capableing of safety and precise.
Specific embodiment
It is described in detail below in conjunction with various aspects of the drawings and specific embodiments to the utility model.Wherein, attached
Component in figure is not necessarily drawn to scale, and focuses on that the principles of the present invention are illustrated.
In each embodiment of the utility model, well-known structure or material are not shown or do not make specifically
It is bright.Also, described feature, structure or characteristic can combine in any way in one or more embodiments.In addition, this
Field is it will be appreciated by the skilled person that following various embodiments are served only for for example, rather than limiting the present invention
Protection scope.Can also be readily appreciated that, the component in each embodiment described herein and shown in the drawings can by it is a variety of not
It is arranged and designs with configuration or ratio.
[first embodiment]
Fig. 1 is according to a kind of schematic diagram of the membrane-repturing device of embodiment of the utility model.Fig. 2 is the membrane-repturing device in Fig. 1
Enlarged diagram at reaming component.Fig. 3 is the sectional view of the membrane-repturing device in Fig. 1.
As shown in Figure 1, including: operating mechanism 1, reaming component 2 and broken according to the membrane-repturing device of the utility model embodiment
Film syringe needle 3, wherein for operating mechanism 1 for carrying out rupture of membranes operation, reaming component 2 is axially set in the operation along operating mechanism 1
One end of mechanism, rupture of membranes syringe needle 3 is along the distal end axially adjacent to reaming component 2 of operating mechanism 1 (i.e. far from one end of operator)
Setting, rupture of membranes syringe needle 3 are arranged to by the operation of operating mechanism 1 to form rupture of membranes hole on film, and reaming component 2 is arranged to broken
Film syringe needle 2 forms the aperture that rupture of membranes hole passes through the operation expansion rupture of membranes hole of operating mechanism 1 later.
In conjunction with Fig. 2 it is found that reaming component 2 is led including the sacculus 21 that can be expanded and shrink, the sacculus being set in sacculus
Pipe 22 and the cutting member 23 for cutting film for being set to sacculus outer surface.
Rupture of membranes syringe needle 3 is fixed on the distal end of foley's tube 22, and foley's tube 22 is fixed on the distal end of operating mechanism 1.Specifically
For, operating mechanism 1 includes operating stick 11, and foley's tube is fixed with 11 phase of operating stick, rupture of membranes syringe needle 3, foley's tube 22 and behaviour
Making bar 11 may be integrally formed a rod-like element, or more from as far as closely setting gradually along the same axis (axial direction of operating mechanism)
A component is fixed to each other to form rod-like element, or is also possible to the other known structure in this field and shape.By rupture of membranes syringe needle,
The composite construction of foley's tube and operating mechanism can increase the supportive of membrane-repturing device, convenient for by harder tissue membrane barriers and
Bracket overlay film.
Rupture of membranes syringe needle 3 and foley's tube 22 and operating stick 11 can be hollow design, for passing through for seal wire, have compared with
Good traceability, the proximal end (close to user) of operating stick 11 have guidewire lumen openings (as shown in figures 1 and 3) for seal wire into
Enter, proximal end is also connected with operation knock-off joint (not shown), for grasping for user (such as doctor) is mobile in use
Make bar so that rupture of membranes syringe needle carries out rupture of membranes, reaming component carries out reaming.
The length of rupture of membranes syringe needle is 10mm.Optionally, the length of rupture of membranes syringe needle can also select other according to actual needs
Numerical value, such as 5mm, 15mm etc., any number within the scope of 2-30mm.It can have developing mark on rupture of membranes syringe needle, such as
It can be point or ring that coating developing material is formed etc. or other labels that membrane puncture needle top guide can be made to develop, for making
With the position for showing rupture of membranes syringe needle in the process, it is conveniently adjusted and positions.Optionally, developing mark also can be set in other positions
It sets, such as on the sacculus of reaming component or on foley's tube etc..
In the present embodiment, foley's tube 22 is metal tube, and rupture of membranes syringe needle 3 is made of metal, and is metal hollow syringe needle,
Operating stick 11 is metal tube, is fixed between three each other by welding or gluing.Optionally, foley's tube be also possible to metal around
Tubulation, macromolecule woven tube, hypotube or other conduits with axial stiffness.Rupture of membranes syringe needle can also be by other hard materials
It is made, such as high molecular material etc..
In the present embodiment, sacculus 21 is made of nylon, is high pressure sacculus, and maximum outside diameter when expanding is 10mm.
Optionally, sacculus can also be made of other high molecular materials, such as polyethylene terephthalate, polytetrafluoroethylene (PTFE), poly-
Urethane, polyvinyl chloride etc., sacculus is also possible to Cutting balloon or other are capable of the sacculus of dilation, can also be according to practical need
Select maximum outside diameter when expansion for the sacculus of other numerical value, such as any number within the scope of 5-40mm.
In conjunction with Fig. 2 and Fig. 3 it is found that operating mechanism 1 further includes full pipe 12,12 housing of pipe is filled outside operating stick 11, it can
With with operating stick 11 is coaxial or off-axis, jointly mobile with operating stick 11, the distal end of full pipe 12 is connected with the proximal end of sacculus 21,
The proximal end of full pipe 12 is connected with the full pipe fitting 13 for outputting and inputting fluid, full to sacculus 21 by full pipe 12
It is set to expand and shrink with discharge fluid (such as liquid or gas).Optionally, fill pipe 12 can be double lumen tube or multi-lumen tube,
For operating stick 11 by be connected with foley's tube, another or multiple inner cavities are connected with to sacculus with sacculus for one inner cavity
21 full and discharge liquid or gas make it expand and shrink, and other modes known in the art, which also can be used, makes balloon inflation
And contraction.
Cutting member 23 is made of metal material, to be evenly distributed on the outer surface of sacculus 21 and along the axis of operating mechanism 1
To 4 blades of setting.Alternatively it is also possible to be 2,3 or multiple blades, it can be uniformly distributed or unevenly divide
Cloth.Optionally, cutting member is also possible to uniformly be wound on the silk of sacculus outer surface, such as wire or other hard materials are made
Silk.In balloon inflation, the height of the outer surface of the sacculus of the prominent expansion of cutting member is 1mm.Optionally, cutting member is prominent
The height of the outer surface of the sacculus expanded out is also possible to other numerical value, such as can be 0.1mm, 1.5mm etc., in 0.1-
Arbitrary value between 1.5mm, such as the arbitrary value between 0.1-1mm, etc..
The proximal end of operating mechanism 1 (such as operating stick 11) can also have scale mark (not shown).In this way, operating stick 11
Therefore movable length can judge what rupture of membranes syringe needle rupture of membranes entered by finding out in the scale mark (length mark) of proximal end
Length.The proximal end of operating mechanism 1 (such as operating stick 11) can also have (not to be shown for limiting the mobile limiting device of operating stick 11
Out), in this way, when needed, the movement of operating stick can be limited, by limiting device to prevent rupture of membranes syringe needle from continuing deeper into or move
Position.For example, limiting device may include nut groove and fixture nut, by tightening fixture nut in nut groove, can make solid
Determine nut to be in close contact with operating stick to increase the two frictional force to keep the two fastened to each other, limitation operating stick is mobile.
Membrane-repturing device may also include locking device (not shown), can be used for that the fluid in full pipe is prevented to pass through, to lock ball
The degrees of expansion of capsule.
Certainly, reaming component 2 is not limited to the design in above embodiment, and those skilled in the art can also be according to reality
Border needs to select any component that can be used for expanding aperture known in the art, such as the inflatable braided support etc. shunk.
[second embodiment]
Fig. 4 is the schematic diagram according to the membrane-repturing device of the utility model another embodiment.Fig. 5 is the membrane-repturing device in Fig. 4
Positioning element at sectional view.Fig. 6 is the sectional view of the outer sheath joint of the membrane-repturing device in Fig. 4.
For the membrane-repturing device of present embodiment compared with the membrane-repturing device of first embodiment, difference is that membrane-repturing device further includes positioning
Component 4.The structure of reaming component, rupture of membranes syringe needle and operating mechanism can be with described in above embodiment, and details are not described herein.
As shown in Figure 4 and Figure 5, positioning element 4 is along the proximal end axially adjacent to reaming component 2 of operating mechanism 1 (close to use
Person) setting, for fixing position of the membrane-repturing device in patient vessel, the inside which passes through positioning element 4 is removable
It is dynamic.
In the present embodiment, positioning element 4 may include the locating support 41 that can be expanded and shrink, in locating support
41 when being in contraction state, and without positioning, user can determine target position with running fix bracket to target position
It afterwards, can be fixed in the blood vessels by locating support 41 by the expansion of locating support 41.
Positioning element may also include sheath to control the expansion of locating support and contraction.Fig. 6 is the outer of the membrane-repturing device in Fig. 4
The sectional view of sheath joint.As shown in Figure 5 and Figure 6, the expansion and contraction of locating support can be controlled by the double-deck sheath.
The double-deck sheath includes outer sheath 42 and interior sheath 43, and 42 housing of outer sheath is outside interior sheath 43, interior sheath and outer sheath edge each other
It can axially relatively move, interior 43 housing of sheath fills 12 housing of pipe outside operating stick 11, locating support 41 outside full pipe 12
One end connect with outer sheath 42, the other end of locating support 41 is connect with interior sheath 43, passes through sheath and outer sheath in controlling
Between relative movement to control the expansion and contraction of locating support 41.
For example, locating support 41 can be braided support.It is knitted by least one braided wires by poor superimposing braid, it is adjacent
Braided wires can enclose and be set as network unit.Wherein, the obtuse angle of network unit may range from 91-179 degree or
100-160 degree or 110-150 degree or 115-140 degree or 120-135 degree, preferably 120-135 degree.The braiding of locating support
Pitch (that is, linear distance along axial two crosspoints) is 0.6mm-1.5mm, and preferably 1.0mm is (in the receipts of positioning element 4
Under contracting state).The string diameter of braided wires can be 0.005 inch -0.02 inch.The cross-sectional shape of braided wires can for it is round,
Oval, trapezoidal, diamond shape or rectangle etc..Braided wires can be made of any one of materials described below: Nitinol, 304 stainless
Steel, 316L stainless steel, L605 cochrome and MP35N alloy etc., preferably nitinol alloy wire, so that positioning branch made of braiding
Frame 41 has better radial positioning power and flexibility.
In the present embodiment, braided wires without dextrorotation derotation coiling (that is, braided wires first dextrorotation coiling from front to back, then
Derotation coiling from back to front) locating support is formed, the both ends (free end) of braided wires are located at the both ends of locating support, Ke Yizhi
It connects and is mutually fixed with interior sheath and outer sheath.In other embodiments, which can also pass through at least one braided wires
Turned to by dextrorotation and derotation, at this point, both ends (that is, longitudinal end) imperforation of locating support, respectively with interior sheath and epitheca
Pipe is mutually fixed.
In the present embodiment, the distal end of locating support can mutually be fixed by hot melt adhesion and interior sheath, locating support
Proximal end can mutually be fixed by hot melt adhesion with outer sheath.It is connected compared to common gluing, hot melt adhesion will not introduce new glue
Agent material is tied, but is directly bonded using sheath itself, such bonding connection intensity is high and for ring needed for medical treatment
For border, the potential danger for introducing other compositions is not had.It is however also possible to which locating support is divided using modes such as other gluings
Do not fixed mutually with interior sheath and outer sheath, for example, using medically acceptable adhesive etc. by locating support respectively with interior sheath
It is mutually fixed with outer sheath.
In the present embodiment, there can be developing mark on locating support, for example, may include at least one in following
Kind: include development silk at least one braided wires, coated in braided wires development point, showing on locating support is set
Shadow ring (for example, developing ring can be set bracket proximally and distally, C-shaped or circular ring-type) or coated on locating support
Development point etc., be also possible to other other labels for enabling locating support to develop.It, can be with by making locating support develop
Convenient for determining the position of locating support in vivo, to ensure the accuracy of rupture of membranes needle-penetration film.
Optionally, locating support can be spherical, shuttle shape or cylinder etc..Locating support can be by wire or height
Braided support made of the braiding of silk made of molecular material, or metal tube or plastic tube is cut by laser and the cutting branch that is formed
Frame.Maximum outside diameter when locating support is in swelling state is 5 millimeters -50 millimeters, can also be selected according to application scenarios difference
The locating support of other sizes.
Optionally, sheath can be the double-deck sheath, be also possible to any locating support that can control known in the art
The component of dilation.
As shown in figure 4, membrane-repturing device further includes the epitheca pipe fitting 44 and interior sheath pipe fitting positioned at proximal end (close to user)
45.Wherein, epitheca pipe fitting 44 is set at the proximal end of outer sheath 42, is female Luer, and interior sheath pipe fitting 45 is set to
At the proximal end of interior sheath 43, interior sheath 43 may pass through the inner cavity that epitheca pipe fitting 43 enters outer sheath 42, and filling pipe 12 can
Enter the inner cavity of interior sheath across interior sheath pipe fitting 45.These connectors are convenient for sheath in user (such as doctor) in operation movement
Pipe and outer sheath.
In use process, after reaching target position, user, which first passes through sheath pipe fitting in mobile, keeps interior sheath relatively outer
Sheath is mobile, expands locating support, membrane-repturing device is fixed on required position, and user passes through moving operation knock-off joint later
(not shown) keeps operating stick mobile so that rupture of membranes syringe needle carries out rupture of membranes, by filling pipe fitting 13 and full pipe 12 to reaming component
Sacculus fill fluid, expand it, then moving operation knock-off joint makes operating stick drive reaming component 2 mobile, so as to expand
Hole component carries out reaming.
Optionally, at outer sheath connector 44, be additionally provided with flushing hole 46, in the double-deck sheath flushing and radiography.
In outer sheath joint, it is also provided with locking device 47, locking device 47 is connected with interior sheath 43, for locking interior sheath
43 with the relative movement of outer sheath 42.Locking device 47 can be fastening screw, by tightening the fastening screw, can lock interior
Sheath no longer moves, thus the relative movement in locking between sheath 43 and outer sheath 42.
[third embodiment]
Fig. 7 is the schematic diagram according to the membrane-repturing device of the utility model another embodiment.
The membrane-repturing device of present embodiment compared with the membrane-repturing device of second embodiment, difference be locating support 41 be can
Expansion and the sacculus shunk control the dilation of locating support 41 by full discharge fluid.Reaming component, rupture of membranes syringe needle
Structure with operating mechanism can be with described in above embodiment, and details are not described herein.
In the present embodiment, for control locating support expansion and contraction sheath 48 be double lumen tube or multi-lumen tube,
One inner cavity passes through for full pipe 12, and inner cavity in addition is used for full to locating support 41 and fluid (liquid or gas) is discharged,
So that balloon-stent expansion and contraction.
As shown in fig. 7, proximal end (close to user) end of the sheath is provided with connector 49, which is female Luer,
For outputting and inputting fluid to sheath.Full pipe 12 may pass through the inner cavity that connector 49 enters sheath.
In use process, after reaching target position, user first passes through connector 49 and sheath 48 is filled to locating support 41
It is full of fluid, expands locating support, membrane-repturing device is fixed on required position, user passes through moving operation knock-off joint later
(not shown) keeps operating stick mobile so that rupture of membranes syringe needle carries out rupture of membranes, by filling pipe fitting 13 and full pipe 12 to reaming component
Sacculus fill fluid, expand it, then moving operation knock-off joint makes operating stick drive reaming component 2 mobile, so as to expand
Hole component carries out reaming.
Certainly, positioning element 4 is not limited to the design of the locating support in the respective embodiments described above, those skilled in the art
Any component that can be used for positioning known in the art can be selected according to actual needs.
The membrane-repturing device of the utility model can be disposably, can also pack after using the sterilization of any suitable technology
In sack, box or other suitable containers.For example, disposable membrane-repturing device can be packed out together with protection coil pipe
It sells, when taking out membrane-repturing device, physiological saline can be used to rinse the membrane-repturing device.
The utility model terminology used herein and wording are just to for example, be not intended to constitute restriction.
It will be appreciated by those skilled in the art that under the premise of not departing from the basic principle of disclosed embodiment, to above-mentioned implementation
Each details in mode can carry out various change.Therefore, the protection scope of the utility model is only determined by claim, in right
In it is required that, unless otherwise indicated, all terms should be understood by the broadest reasonable meaning.