CN1225027A - Low profile catheter valve - Google Patents

Low profile catheter valve Download PDF

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Publication number
CN1225027A
CN1225027A CN 97196352 CN97196352A CN1225027A CN 1225027 A CN1225027 A CN 1225027A CN 97196352 CN97196352 CN 97196352 CN 97196352 A CN97196352 A CN 97196352A CN 1225027 A CN1225027 A CN 1225027A
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CN
China
Prior art keywords
fluid
hermetic unit
valve
inflation
chamber
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Pending
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CN 97196352
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Chinese (zh)
Inventor
吴拉姆·礼萨·扎德尼·阿齐兹
阿普里尔·A·莫拉诺·福特
塞尔索·J·巴高伊桑
杰弗里·C·布利姆
伊萨克·J·基姆
杰弗里·F·菲尔德
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Medtronic Vascular Inc
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Percusurge Inc
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Application filed by Percusurge Inc filed Critical Percusurge Inc
Priority to CN 97196352 priority Critical patent/CN1225027A/en
Publication of CN1225027A publication Critical patent/CN1225027A/en
Pending legal-status Critical Current

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Abstract

The invention discloses a low profile catheter valve with a removable sealing part in an aerating chamber of catheter. The sealing part contacts with whole circuity of partly aerating chamber closely to forming a fluid sealing, which enables fit on the side of aerating hole adjacent to the catheter to build a fluid channel between the aerating hole and aerating ball at end of the catheter. As expected, clinician can move the sealing part to a position which far away from the aerating hole to prevent any fluid through the aerating hole flowing or discharging from the ball.

Description

Low profile catheter valve
The present invention relates generally to a kind of conduit, in more detail, is a kind of low profile catheter valve, and it can be opened, and makes catheter-balloon inflation or venting such as the locking sacculus, and can close when needing, and makes catheter-balloon keep inflated condition.
The various Medical Instruments that seal wire is generally used for guiding such as conduit are inserted desirable therapentic part among the patient vessel.In typical therapeutic process, the clinicist opens a mouth on the blood vessel tip such as femoral artery, for seal wire forms an insertion point, very softish seal wire inserts the blood vessel tip by opening, advanced along patient's blood vessel by the clinicist then, pass the part that blood vessel need be treated until seal wire.Various treatment conduits as the sacculus dilating catheter of using in the percutaneous sacculus coronary angioplasty, can insert and similarly be needed until arrival along the blood vessel propelling position of treatment by seal wire.
In some therapeutic process, the seal wire that needs the edge to be positioned over a certain ad-hoc location inserts successively and extracts many different treatment conduits.In other words, different treatment conduit " exchange " in same seal wire.Such exchange generally comprises and extract the treatment conduit out from seal wire, all extracts in patient's body and insertion patient's the seal wire part until the treatment conduit.At this moment, seal wire can be used as the guider of another different treatment conduits.
In the insert sealing device, utilize two closure ball capsules to form a chamber usually, can not change the treatment conduit under the situation to the venting of sealing sacculus like this.Say further, so often help in replacing fixedly seal wire.Be readily appreciated that, from the seal wire that places, extract the treatment conduit out and can cause seal wire to depart from its position.For overcoming this difficulty, prior art has been invented " fixable type " seal wire, and main feature is that some structures of its terminal termination can be with the dismountable a certain ad-hoc location that is fixed on the patient of seal wire, to guarantee the continuity of therapeutic process.Such fixable type seal wire, once in people's such as Cohen patent, United States Patent (USP) 5,167 provided in No. 239.This patent provides a kind of seal wire of hollow, and an inflatable chamber and an expandable balloon are arranged in its end.The Cohen seal wire is located in the mode identical with the seal wire of routine, but in case behind the location, its expandable balloon is inflated, contacts with on every side blood vessel, prevents the skew of seal wire with this.
Because fixing manifold inflation, promptly use the fixedly manifold inflation of the sort of type of the conventional conduit that has inflatable balloon, will stop other conduit to insert in the Cohen seal wire, so the Cohen device also comprises a dismountable manifold inflation and the check valve that still can make sacculus keep inflated condition when manifold is removed.The used check valve apparatus of Cohen device is too big comparatively speaking, and described in its most preferred embodiment, its external diameter is 0.0355 inch.Therefore, any treatment conduit of wanting to insert the Cohen device must have an inside guidewire lumen greater than Cohen valve external diameter, promptly in most preferred embodiment, needs a diameter greater than 0.0355 inch inner chamber.
Increase the size of treatment conduit cavity, the external diameter that will cause treating conduit increases, and this is readily appreciated that for the people who is skilled in technique.At the blood vessel very big to diameter, in the therapeutic process as intestinal arteries, the essential size that the device that the guidewire lumen if will have of treatment conduit is provided with Cohen adapts, conduit will be difficult to or can't fix in blood vessel at all.Yet, it is very narrow that many needs carry out the blood vessel of catheter treatment, for example, the diameter range of left coronary artery is 2 to 4 millimeters, and be prone to atheromatous plaque, this just need carry out conduit and exchange therapeutic process, treats this illness such as urethroptasty, but the internal diameter that coronary artery is very narrow makes and uses the very big fixable type seal wire of valve diameter to become very unactual.
Therefore, we need a kind of catheter valve with very little profile, can use together with the seal wire of hollow.
The invention provides a kind of catheter valve, especially be suitable for using together, and be equally applicable to therapy equipment or locked instrument with fixable seal wire with very little profile.Valve of the present invention is inserted in these devices, and making and producing external diameter is that 0.014 inch or littler fixable type seal wire and locked instrument conduit become possibility.More advantageously, by use the present invention in these conduits, the clinicist can use fixable type seal wire, therapy equipment or locked instrument conduit in than narrower in the past blood vessel.
On the one hand, the invention provides a kind of valve, it comprises that one has cardinal extremity and terminal flexible elongate tube body, and body has one to extend to terminal inner chamber from cardinal extremity, and inner chamber has an opening at cardinal extremity
An expandable member as inflatable balloon, is positioned at the end of body, and expandable member is connected with cavity fluid.An inlet is arranged on body, and inlet is connected with cavity fluid, so that exert pressure at inlet expandable member is expanded.
A seal member, its hermetic unit seal up a surface of body.The hermetic unit of seal member can move between the two positions with respect to the above-mentioned surface of body.In first position, hermetic unit is positioned at and contacts with the body surface and stop fluid to flow into by inlet or flow out the position of expandable member with the expansion of keeping expandable member.Second position, hermetic unit is positioned at and allows fluid to flow into by inlet or the outflow expandable member, so that the position that makes the expandable member expansion or shrink.
In a most preferred embodiment, the part of seal member is extended from the cardinal extremity of body, applies axial force in this extension and will cause hermetic unit to move to the direction of applying power.In other embodiments, may apply revolving force and come the hydrodynamic reciprocating sealing parts.
The most handy polymeric material of hermetic unit, as Pebax, silicone, making such as C-Flex (TM) or gel.When hermetic unit between terminal and inlet during the position, hermetic unit has and must can bear inflated pressure, and stops any fluid to flow into by inlet fully or the ability of outflow expandable member.Its advantage is that the external diameter of the body external diameter than seal member any part or hermetic unit usually is all big.In certain embodiments, the external diameter of body is no more than 0.038 inch, and is relatively good when being no more than 0.020 inch, preferably is no more than 0.014 inch.Among other embodiment, body has bigger external diameter, and body may also have scotch, prevents that seal member from withdrawing from from opening part.
On the other hand, the invention provides a kind of device, it comprises a wire guide that the hollow of inner chamber is arranged, and a side inlet that is connected with cavity fluid is arranged.An inflatable balloon is installed on the seal wire, and inflatable balloon is connected with cavity fluid, thereby fluid can flow into by side inlet, makes inflated.
Valve is slidingly installed along the surface of seal wire, and valve can move between first and second positions, it is characterized in that, inner chamber can be sealed in a position, and any like this fluid all can not flow into or flows out inflatable balloon by the side entrance.
The circumference of hollow seal wire has determined first valve, and wherein the girth of removable valve is less than first valve.The recommendation of hollow seal wire outer circumference is 0.12 inch or littler, 0.08 inch or more hour relatively good, be preferably 0.044 inch or littler, and the diameter of removable valve is not more than the diameter of hollow seal wire basically.
On the other hand, the invention provides a kind of low profile catheter valve, it has a seal member can move the inflatable chamber that inserts conduit along the cardinal extremity opening of conduit.Conduit comprises a side air-filled pore and an inflatable balloon that keeps fluid to be connected with the side air-filled pore.A hermetic unit is arranged on the seal member, and it can form fluid-tight with the whole circumference of intracavity section.Like this, any fluid all can not pass through hermetic unit under the sacculus normal inflation.
When hermetic unit is arranged in position near the inner chamber of side air-filled pore, between side air-filled pore and sacculus, form unimpeded fluid passage.When hermetic unit was arranged in position away from the inner chamber of side air-filled pore, any fluid all can not be under the sacculus normal inflation flows into by the side air-filled pore or flows out sacculus.
On the other hand, the invention provides a kind of method to the catheter-balloon inflation.This method at first provides a kind of pipe that a cardinal extremity and an end are arranged.The cardinal extremity of pipe has an air-filled pore that leads to inflatable chamber, and the end of pipe has an inflatable balloon that is connected with the inflatable chamber fluid.So the pressurization aerated fluid imports to inflated by air-filled pore.Hydrodynamic reciprocating sealing parts in inflatable chamber make air-filled pore sealed under the situation that pressure fluid pressure does not reduce then, and its seal process is finished under the situation of the not obvious venting of inflating balloon.At last, the pressure of pressure fluid can reduce after finishing the sealing step.
On the other hand, the invention provides a kind of low profile catheter valve that uses with the inflation adapter.Valve comprises a seal member, and the sealing parts can insert in the inflatable chamber of conduit by supravasal cardinal extremity opening.Conduit has an air-filled pore and an inflatable balloon that is connected with the air-filled pore fluid.A labelling is arranged on conduit and/or seal member, and when conduit and seal member were fixed on the inflation adapter, its position made air-filled pore aim at a fluid-tight inflatable chamber inflating adapter.
A hermetic unit is housed on the seal member, and it can form fluid-tight with the whole circumference of intracavity section, and like this, any in fact fluid all can not pass through hermetic unit under the sacculus normal inflation.When hermetic unit is positioned at position near air-filled pore, between air-filled pore and sacculus, form unimpeded fluid passage.When hermetic unit was positioned at position away from air-filled pore, any in fact fluid all can not flow into or flows out sacculus by the side air-filled pore.
On the other hand, the invention provides a kind of inflation adapter, it is used to aerated fluid is imported in the air-filled pore of elongated tubular.The inflation adapter has a shell, and shell comprises first, second two parts, and these two parts act on one section pipe of removably clamping together.Shell has a chamber, is used to hold air-filled pore.An inflation inlet is arranged on the shell, have the structure that can be connected, so that above-mentioned pressure fluid to be provided with the aerated flow body source.A sealing ring removably seals up two parts of above-mentioned shell, thereby forms a fluid passage between inflation inlet and air-filled pore, and like this, the fluid after the pressurization just can be transported to air-filled pore.An actuator that is installed on the above-mentioned shell is used for a element in the driving tube and controls fluid and flow through above-mentioned air-filled pore.
On the other hand, the invention provides a kind of inflation adapter, it is used to aerated fluid is imported the air-filled pore of elongated tubular.The inflation adapter has a shell, and shell has first, second two parts.These two parts have formed a mouth shape structure and have held the one section pipe that contains air-filled pore.This mouth shape structure has formed an opening, and external diameter with pipe is the same big highly at least for it.Like this, the part of pipe can be from the side of mouth shape structure, along inserting in the mouth shape structure with the vertical direction of the centrage of pipe.Shell also has an inflatable chamber and an inflation inlet that is used for the pressurization aerated fluid is imported inflatable chamber.Inflatable chamber removably seals up air-filled pore and inflation inlet, forms a fluid passage betwixt.
On the other hand, the invention provides a kind of inflation adapter, it is used to aerated fluid is imported the air-filled pore of elongated tubular.An inflatable element is installed on the pipe, an inflatable chamber is arranged between air-filled pore and inflatable element.Adapter has a shell to be made into the structure that seals with body, forms fluid-tight.An inflation inlet is arranged on the shell, make between inflation inlet and air-filled pore and form a fluid passage, allow inflatable element to be inflated.Shell can be pulled down from pipe under the situation of the inflatable element venting that does not make expansion.
Below in conjunction with description of drawings most preferred embodiment of the present invention.
Fig. 1 is the side view that a conduit of pet-valve of the present invention is housed.
Fig. 2 is the enlarged drawing of conduit cardinal extremity shown in Figure 1, has shown with pet-valve of the present invention to be the duct portion of feature.
Fig. 3 A is the axial plane cutaway view of duct portion shown in Figure 2, has shown the pet-valve that is in the enable possition.
Fig. 3 B is the axial plane cutaway view of duct portion shown in Figure 2, has shown pet-valve in the closed position.
Fig. 4 is the axial plane cutaway view of an interchangeable embodiment, has shown pet-valve in the closed position.
Fig. 5 is an axial plane cutaway view embodiment illustrated in fig. 4, has shown the pet-valve that is in the enable possition.
Fig. 6 is the axial plane cutaway view of an interchangeable embodiment of pet-valve, has shown the pet-valve that is in the enable possition.
Fig. 7 is an axial plane cutaway view embodiment illustrated in fig. 6, has shown pet-valve in the closed position.
Fig. 8 is the perspective view that is used to operate the inflation adapter of pet-valve of the present invention.
Fig. 9 A is the perspective view of inflation adapter shown in Figure 8 inside.
Fig. 9 B is the perspective view that has the conduit of seal member and alignment labelling on the adapter of inflation shown in Fig. 9 A.
Figure 10 is the end-view of an interchangeable embodiment of inflation adapter.
Figure 11 is the transverse sectional view of inflation adapter shown in Figure 10 along the 10-10 line.
Figure 12 and Figure 13 are the exploded views of the alternative embodiment of pet-valve of the present invention.
Figure 14 is an alternative embodiment of the pet-valve of the present invention that is feature with interior dress bias spring.
Figure 15 A and Figure 15 B are the axial plane cutaway views of conduit cardinal extremity shown in Figure 14, have shown respectively to be in the valve of closing with the enable possition.
Fig. 1 has shown the conduit 10 that pet-valve of the present invention is housed.Though be example only, should be understood that pet-valve of the present invention can adapt to various foley's tubes at an easy rate, comprises the conduit that those have additional function, structure and special-purpose with the simple closure ball ductus bursae that only has an inflatable chamber and an inflating balloon.For example, pet-valve is to such as the conduit with expandable member of treatment with expansion of balloon catheter, and comparing the closure ball ductus bursae has stronger adaptive capacity.And pet-valve of the present invention also can be loaded in the conduit with two or more cavitys.By following explanation, how pet-valve of the present invention and those there are the conduit assembling of various functions, structure and special-purpose, concerning the people who is skilled in technique, can be easy to.
Conduit 10 mainly comprises an elongated flexible body 18 that extends to terminal function termination 14 from cardinal extremity control termination 12.Body 18 have one from the termination 12 inner chambers 40 that extend to termination 14.Inner chamber 40 has an opening 23 in cardinal extremity termination 12, and endways termination 14 by fluid-tight.The length of body 18 may be obviously different according to different needs.As common need percutaneous sacculus coronary angioplasty to the femoral artery opening in, conduit 10 is used as the seal wire of other conduit, the optimum length scope of conduit 18 is about 120 centimetres to 140 centimetres, commonly used is about 180 centimetres.In addition,, do not need so long body 18, can adopt the body 18 of lacking some for different operations.
Generally speaking, body 18 cross sections are common circle, and its external diameter is in about 0.010 inch to 0.044 inch scope.Be used as in the application of seal wire of other conduits at most of conduits 10, the external diameter of body 18 should be 0.020 inch or littler as far as possible between 0.010 inch to 0.038 inch, and preferably external diameter is 0.014 inch or littler.The size of inner chamber 40 is somewhat dependent upon the external diameter of body 18.For example, external diameter is 0.014 inch a body 18, and the internal diameter of inner chamber 40 is about 0.008 inch to 0.010 inch.The diameter of inner chamber 40 should be even as big as the following pet-valve of packing into, and reserves enough fluid passages for inflated.
The inner chamber 40 of noncircular cross section also can be suitable for mutually with pet-valve of the present invention.For example, right angled triangle, ellipse or other non-circular cross sectional shape also can easily be assembled with the present invention mutually, and this will be understood by those people who is skilled in technique.By following description, the method for attachment of pet-valve of the present invention will be quite distinct.
In most preferred embodiment, body 18 is as seal wire, and therefore, body 18 must have suitable structural integrity, or " propulsion capability ", so that conduit 10 is when being advanced into the tremulous pulse terminal position by blood vessel, body 18 does not bend and intentional deformation.In addition, also require body 18 that the ability of transmitting moment of torsion is arranged, in the embodiment that is rotated need body 18 in inserting patient's body at some after.Known to the people who is skilled in technique, many biocompatible material that have these characteristics and be suitable for catheter fabrication can be used to make body 18.For example, can use rustless steel, perhaps the polymeric material such as nylon, polyamide, polyimides, polyethylene and other chemical compounds is made body 18.In a most preferred embodiment, desired structural integrity and transmission torque capability can be passed through by Ti-Ni alloy, and the body 18 that is commonly referred to as the material of NiTi nobelium is realized.In another most preferred embodiment, contain 50.8% nickel in the NiTi nobelium alloy of manufacturing body 18, all the other compositions are titanium, and this material is produced by Memry company, and its commodity are called Tinel (TM).Find now that the catheter tube of being made by this Nitinol is than have better pliability and counter-bending ability also to be improved with other materials.
As shown in Figure 1, the terminal termination 14 of conduit 10 has atraumatic tip 16 and dilating sacculus 20.Dilating sacculus 20 can be suitable for the material manufacture that sacculus is produced with any known to the same domain person skilled in the art.For example, dilating sacculus 20 can be made as polyethylene or rubber with the material with expandable characteristics.In a most preferred embodiment, dilating sacculus 20 is used as the sealing sacculus, and the styrene-ethylene-butylene-styrene polymer (SEBS) that preferably adopts commodity to be called C-Flex (TM) is made.Interchangeable, in inflating balloon 20 some most preferred embodiment as expanded balloon, it can be made by not expansive material such as terephthalate polyethylene, and any method known to the skilled personnel of inflating balloon 20 available techniques is as hot weld or gluing being connected on the body 18.
As shown in Figure 1, conduit 10 has a side air-filled pore or an opening 22 that forms apart from opening more than 23 centimeters on body 18.Air-filled pore 22 keeps fluid to be connected with the inner chamber 40 that extends along body 18.Being inflated on body 18 has a filler opening (not shown) in sacculus 20 enclosed areas, this makes and enters inner chamber 40 by the fluid air-filled pore 22 of flowing through, and gives sacculus 20 inflations.On the contrary, extract the fluid in the sacculus 20 out,, discharge, can make sacculus 20 venting through side air-filled pore 22 by inner chamber 40.
Pet-valve of the present invention not only can be used for above-mentioned conduit, can also be used for the conduit of various different structures.In a certain most preferred embodiment, pet-valve have one can running fix in conduit cavity seal member.In some most preferred embodiment, supravasal air-filled pore also is the opening of inner chamber at the conduit cardinal extremity.An inflatable balloon is positioned at catheter tip, keeps fluid to be connected with inner chamber and air-filled pore.The inside that seal member inserts inner chamber by the cardinal extremity opening, its part is protruding from the cardinal extremity of conduit.The part that seal member inserts inner chamber has a hermetic unit, forms fluid-tight, the hermetic unit in case the fluid stopping body is flowed through with inner chamber.
By pushing or pulling at the seal member extension, seal member correspondingly in inner chamber part advance or retreat, thereby in inner chamber the hydrodynamic reciprocating sealing part.In this way, can make hermetic unit in inner chamber, be near or away from the position of air-filled pore.When hermetic unit was in position near air-filled pore, valve was in " unlatching " state.Behind the opening of valves, between air-filled pore and sacculus, form a unimpeded fluid passage, external pressurized fluid source and air-filled pore are connected, thereby give inflated.Perhaps,, can extract the fluid in the sacculus out, sacculus is exitted by to the air-filled pore evacuation if sacculus has been full of gas.When hermetic unit was in position away from air-filled pore, valve was in " cutting out " state, owing to form fluid-tight between inner chamber and hermetic unit, will stop fluid to flow into by air-filled pore or the outflow sacculus.And when after the inflated during shut off valve, the fluid-tight that hermetic unit produces need not external source of fluid, can prevent that still the pressure fluid in the sacculus from flowing out, thereby make sacculus keep expansion state.
Fig. 2, Fig. 3 A and Fig. 3 B have described the pet-valve of the present invention that uses together with conduit shown in Fig. 1.As mentioned above, conduit 10 has a side air-filled pore 22 that fluid is communicated with inner chamber 40, can import dilating sacculus 20 by its fluid.Inner chamber 40 has an opening 23 at cardinal extremity 12.Seal member 30 inserts inner chambers 40 by opening 23, and by the longitudinal force effect, seal member 30 can partly pass in and out inner chamber 40, correspondingly also can near or away from cardinal extremity 12.
Seal member 30 comprises main shaft 33, tapered zone 31 and silk 32.Seal member 30 can be made single piece as rustless steel, NiTi nobelium etc. by suitable metal.For example, seal member 30 can be made into whole column, presses in certain some casting along its length then to form tapered zone 31 and silk 32.Interchangeable, can make one or more main shaft 33, tapered zone 31 or silk 32 respectively, use usual method such as welding to be connected then and form seal member 30 with miscellaneous part.Polymeric material such as Delron (TM), nylon etc. also can be used to the whole method of making or make respectively the back assembling and make seal member 30.
Though do not require, in a most preferred embodiment, the external diameter of main shaft 33 should not surpass the external diameter of catheter tube 18.Therefore, if body 18 external diameters are 0.014 inch, the maximum outside diameter of the external diameter of main shaft 33 and seal member 30 should be greater than 0.014 inch, and make main shaft 33 from stretch out several centimetres distance of opening 23 as far as possible, so that on main shaft 33, axially exert oneself, to handle silk 32 moving in inner chamber 40.Moreover after conduit 10 inserted in patient's body fully, the main shaft 33 of elongation more had superiority on these functions than common seal wire prolongation, because it provides a starting point for the clinician inserts other conduits on main shaft 33 and conduit 10.
Can be obviously different when conduit 10 is made with the length overall that prolongs main shaft 33, and can adapt to required other conduits with conduit 10 and main shaft 33 uses of packing into.For example when in the most preferred embodiment of conduit 10 " insert silk " during as the seal wire of other conduits, conduit 10 and the length overall that prolongs main shaft 33 are preferably about 300 centimetres.Interchangeable, when conduit 10 in simple operation embodiment or " quick change " embodiment during as the seal wire of other conduits, conduit 10 and the length overall that prolongs main shaft 33 are preferably about 180 centimetres.Be readily appreciated that, but the single length significant change of conduit 10 and main shaft 33, but their length overall still can be satisfied the demand.For example, main shaft 33 assemblings that the conduit 10 and the length of 180 centimeter length is 120 centimetres can be satisfied " inserting silk " 300 centimetres of required length overalls of most preferred embodiment.
In another embodiment, do not need oversize main shaft, only need the main shaft of several centimetres extension from conduit 10 extensions.This shorter main shaft has an adnexa (not shown), and this adnexa is used for the dismountable main shaft that is contained in long extension, so that this conduit 10 also can be used as the seal wire of other conduits.
The diameter of main shaft 33 applies motive force so that be easier to seal member 30 more preferably greater than the other parts of seal member 30.Tapered zone 31 can be placed between main shaft 33 and the silk 32 like that, so that the external diameter of seal member 30 carries out the transition to the minor diameter of silk 32 from the major diameter of main shaft 33.In Fig. 1-3 illustrated embodiment, silk 32 slides and inserts opening 23 and inner chamber 40.Correspondingly, the external diameter of silk 32 must be less than the internal diameter of inner chamber 40, so that silk 32 can insert wherein smoothly.And in those embodiment, when valve was in the enable possition, extended through air-filled pore 22 terminads the termination of silk 32, and the slit between silk 32 external diameters and inner chamber 40 internal diameters should be enough big, in order to avoid the significant limitation fluid flows into or outflow air-filled pore 22 through inner chamber 40.Preferably silk 32 external diameters are littler 0.001 inch to 0.004 inch than inner chamber 40 internal diameters, are beneficial to silk 32 and slide in inner chamber 40 and allow aerated fluid to flow.
In a most preferred embodiment, silk 32 and conduit 10 are equipped with retainer, deviate from from the cardinal extremity of conduit 10 to prevent silk 32.Among this embodiment shown in Fig. 3 A and the 3B, a pair of annular ring that is installed in respectively on silk 32 and the inner chamber 40 is arranged.On first annular ring, 34 coaxial any that are fixedly mounted on the silk 32 that places in the inner chamber 40.The second corresponding annular ring of installing 35 near the inner surface of the inner chamber 40 of cardinal extremity 12 to projecting inward.The internal diameter of annular ring 35 openings is a bit larger tham the external diameter of silk 32, in order to avoid the silk 32 in the restriction inner chamber 40 is mobile.Yet the external diameter of annular ring 34 is greater than the internal diameter of annular ring 35 openings, and this just makes circle 34 match with circle 35, deviates from from conduit 10 cardinal extremities to prevent threads 32.
Circle 34 and 35 available energies are respectively fixed to any material of silk 32 and inner chamber 40 and make, and these materials have the enough structural rigidity as retainer.For example suitable material has metal and various hard polymer, as rustless steel and politef (TM).In a most preferred embodiment, silk 32 and body 18 all use the NiTi nobelium to make, and circle 34 and 35 is also made with the NiTi nobelium, and are welded in respectively on silk 32 and inner chamber 40 inwalls.
Same domain person skilled in the art can understand, and other corresponding constructions that are different from chocking construction described here can be used for also preventing that silk from 32 deviating from fully from conduit 10.For example, annular ring 34 can be radial outwardly directed being suitable for circle 35 pairings in case the protrusion replacement that silk 32 is deviate from from silk 32 by one or more.Interchangeable, the bellows body 18 that annular ring 35 can slightly be stoped circle 34 to move on the ripple tip replaces.
Chamber hermetic unit 36 coaxial being assemblied in securely on the silk 32, hermetic unit 36 be positioned on the silk 32 away from circle 34 a bit on, like this, as shown in Figure 3A, withdraw from by silk 32 part from conduit 10, make hermetic unit 36 can be positioned at a bit locating near air-filled pore 22 in the inner chamber.Hermetic unit 36 also should be positioned on the silk 32 so a bit to be located, and when silk 32 safety were inserted in the inner chamber 40, shown in Fig. 3 B, the hermetic unit that is placed in this some place can not only be sealed air-filled pore 22 fully and be in a bit locating away from air-filled pore 22 in the inner chamber 40.The leading edge 36a and the back edge 36b of hermetic unit 36 preferably have chamfering, so that hermetic unit 36 is when the air-filled pore 22, its edge does not block hole 22.
Hermetic unit 36 preferably forms fluid-tight with the external diameter of silk 32, the internal diameter of inner chamber 40, flows through hermetic unit 36 to prevent the fluid in the inner chamber 40.In the embodiment shown in Fig. 3 A and Fig. 3 B, this is by the hermetic unit on the silk 32 36, along the closely knit part of hermetic unit length direction, closely contacts with girth in inner chamber 40 whole of part and to realize.This applying between the inner surface of the outer surface of hermetic unit 36 and inner chamber 40 is closely, has therefore formed and has prevented that fluid from flowing through the fluid-tight of hermetic unit 36.Yet hermetic unit 36 must move in inner chamber 40 along with main shaft 33, tapered zone 31 and moving of silk 32.Therefore, the applying between hermetic unit 36 and the inner chamber 40 should be too not tight yet, so that by the enough axial forces that act on the main shaft 33 hermetic unit 36 in inner chamber 40 is moved.And, when hermetic unit 36 moves around in inner chamber 40, must be kept by the fluid-tight that the applying between inner chamber 40 and the hermetic unit 36 forms.
Hermetic unit 36 must also can be kept sealing under the fluid pressure that is generally used for the dilating catheter sacculus, and also can keep sealing under the pressure that exceeds common expansion pressure.Hermetic unit 36 can be kept sealing under up to 10 atmospheric pressures better, and it is better to keep sealing under up to 30 atmospheric pressures, and it is best to keep sealing under up to 60 atmospheric pressures.Hermetic unit 36 forms this structural advantages of sealing when preferably can also still not lose it after through the opening of valves repeatedly and the circulation of closing and standing 10 to 60 atmospheric pressure.Best, hermetic unit 36 can stand 10 times even 20 openings of valves and closing at least, and still can keep sealing when 10 atmospheric pressures.
In a most preferred embodiment, these desirable characteristics of hermetic unit 36 can satisfy with the hermetic unit of being made by the polymer pipe of extrusion modling 36.Pebax (TM) pipe of 0.008 inch of internal diameter, 0.017 inch of external diameter, hardness 40 is heated to Fahrenheit 210 to 250 degree, at first drawing-down.Then long tube is cut into every segment length and is 0.5 millimeter pipe.It is on 0.006 inch the NiTi nobelium silk that the Pebax that cuts (TM) pipe is placed to external diameter subsequently, and heating is shaped as the pipe of external diameter between the 0.010-0.011 inch.Afterwards, with bonding agent Loctite 4041 (TM) Pebax (TM) pipe of heat setting is bonded on the NiTi nobelium silk.After treating that bonding agent dries, the leading edge and the back edge of bonding Pebax (TM) seal of tube are trimmed, and staying one section contact length is the tube ring of 0.010 inch (0.25 millimeter).The opening that has the silk NiTi nobelium conduit that to be inserted with an internal diameter be 0.096 inch chamber of Pebax (TM) hermetic unit.This sealing is proved to be, and can bear up to 30 atmospheric pressure and stand repeatedly to open valve and close valve, and the not obvious sealability that reduces.
Inventor's imagination except the above, also should have additive method and material can be used for making the chamber hermetic unit with desirable characteristics.For example, except Pebax (TM), silicon, rubber, C-Flex (TM), Nusil (TM) and gel also all are the known materials that can be used to make hermetic unit 36, and these materials all have the surface characteristic as hermetic unit, and enough smooth, it is moved in inner chamber 40.In addition, hermetic unit 36 can be connected on the silk 32 with different modes, as with hermetic unit 36 integral casts on silk 32, the hermetic unit 36 that is shaped is inserted on the silk 32, and other modes on the silk 32 that polymeric material is bonded at known to the same domain person skilled in the art.
The hermetic unit of other embodiment may not can form a complete fluid-tight between hermetic unit and inner chamber under balloon dilatation pressure.Yet, in these embodiments, the sealing that hermetic unit produces can stop any expansion fluid hermetic unit of flowing through in fact, so that the expansion packaged unit is kept and is continued at least 1 minute at expansion state almost completely, better be 2 minutes or longer, better again is at least 10 minutes, preferably at least 20 minutes or longer, and during this period of time, still can any insert in the blood vessel effectively be sealed clinically.
In a most preferred embodiment, there is a locomotivity to increase structure, in order to increase from driving valve to the power of closing valve position hydrodynamic reciprocating sealing part 36.This structural advantages is, has reduced in the medical operating the accidental then risk of sacculus contraction of opening of valve significantly.In Fig. 3 A and Fig. 3 B illustrated embodiment, by realizing this point at a bias spring 37 that is enclosed between stopper ring 34 and 35 on the silk 32.Spring 37 is the application of force on stopper ring 34, promotes it, so because retroaction terminad direction promotes silk 32 and hermetic unit 36, like this, hermetic unit 36 forms a fluid-tight by coverage hole 22 or by being positioned in intracavity away from a bit going up of hole 22.Because lack resistance, inevitably, spring 37 can keep hermetic unit 36 to be in the pass valve position.By towards direction near termination 12, be applied to the effect of the axial force of the elastic force that is enough to overcome spring 37 on the main shaft 33, hermetic unit 36 can be to moving near the direction of driving valve position.Selected spring 37 preferably makes and acts on the main shaft 33 in order to overcome the power of spring 37 elastic force, in the scope of about 0.3 to 1.0 ppf.In other embodiments, locomotivity increases structure can comprise the ripple that just in time can import near that section of hermetic unit silk, and as described below, it also can provide the resistance of 0.3 to 1.0 ppf scope.
Figure 4 and 5 are depicted as the valve of other embodiments of the invention.Other embodiment have a conduit 110, and its characteristics aspect material, 26S Proteasome Structure and Function are identical in essence to conduit shown in Figure 3 with Fig. 1.Conduit 110 has a cardinal extremity 112 and a terminal (not shown) that is installed on expansion member such as the dilating sacculus.Inner chamber 140 extends between the cardinal extremity of body 118 and end.Inner chamber 140 has an opening 123 on the cardinal extremity 112 of conduit 110.
As previously mentioned, seal member 130 inserts inner chamber 140 by opening 123.Seal member 130 comprises a hermetic unit 136, one rhizoids 132, a pair of annular ring 134 and 135, and support component 150.Seal member 130 can be made of foregoing material and method.
As shown in Figure 4 and Figure 5, insert inner chamber 140 smoothly in order to make seal member 130, silk 132 external diameters should be less than the internal diameter of inner chamber 140.And chamber hermetic unit 136 is coaxial and be installed to securely near silk 132 ends.Hermetic unit 136 forms fluid sealing with silk 132 external diameters and inner chamber 140 internal diameters, so that under 1 to 3 that is used for locking device atmospheric normal inflated pressure, to the sacculus of other patterns under 10 atmospheric pressure or bigger pressure, prevent to enter the fluid of inner chamber 140, flow through hermetic unit 136 by opening 122.Hermetic unit 136 can have leading edge 136a and back edge 136b, and they all have chamfering, is beneficial to hermetic unit 136 and moves around at air-filled pore 122 places.Hermetic unit 136 closely contacts with the whole inner periphery of one section inner chamber 140 along the closely knit part of its length direction, forms a fluid-tight.As previously mentioned, hermetic unit 136 fully stops all fluids to flow through the sealings that hermetic unit 136 forms, and hermetic unit 136 122 places move around and make valve be in unlatching, closed position in the hole.
The supporting positive stop that comprises hollow circular cylinder 134 and 135 is deviate from from inner chamber 140 in order to prevent seal member 130.Additive method known to hollow circular cylinder 135 usefulness bonding agents, welding, crimping or the same domain person skilled in the art is assemblied on the inner surface of inner chamber 140, so that the cardinal extremity of hollow circular cylinder 135 partly stretches into inner chamber 140, and be fixed there, simultaneously, the end portion of cylinder 135 is stretched out from cardinal extremity 112.Cylinder 135 has a chamber (not shown) to extend and runs through wherein.The diameter of cylinder body cavity is greater than the external diameter of silk 132, so that silk 132 is mobile unrestricted.Second hollow circular cylinder 134 is a little preferably short, is placed on the silk 132 and is installed to a bit locating away from cylinder 135 on the silk 132 securely with welding or additive method.The external diameter of cylinder 134 is not more than the internal diameter of inner chamber 140, so that do not limit silk 132 moving in inner chamber 140.Yet the external diameter of cylinder 134 is greater than the intracavity diameter of cylinder 135, so that can prevent that as the cylinder 134 and 135 of supporting retainer silk 132 from deviating from from inner chamber 140.Cylinder 134 and 135 can be respectively with can be attached to any material on silk 132 and the inner chamber 140, and these materials should be useful on enough structural rigidity of making retainer.The example of suitable material has metal and various hard polymer such as rustless steel, Telfon (TM) etc.In a most preferred embodiment, silk 132 and body 118 are all used the manufacturing of NiTi nobelium, and cylinder 134 and 135 is also made with the NiTi nobelium, and are welded on respectively on silk 132 and inner chamber 140 inner surfacies.
Insert support component 150 from the end portion that the cardinal extremity 112 of cylinder 135 stretches out.Support component 150 has a body 158, and the external diameter of this body 158 is approaching the same with the inside and outside footpath of body 118 with intracavity diameter.Inevitably, because the external diameter of cylinder 135 is less than the intracavity diameter of support component 150, the inner chamber of the support component 150 so that extension of cylinder 135 is packed into smoothly.
As shown in Figure 4 and Figure 5, silk 132 stretches out to cardinal extremity from the cylinder 135 that is arranged in support component 150.Silk 132 that part of support component 150 in are fixed on the support component 150 putting 152 places.Silk 132 can be fixed on the support component 150 with any method known to the same domain person skilled in the art, comprises bonding agent, crimping, soldering or welding.Because silk 132 is fixed on the support component 150, the axial force that acts on the support component 150 can cause that seal member 130 moves in inner chamber 140, thereby opens or close valve of the present invention, as described in reference Fig. 1-3.Use the advantage of support component 150 to be, when seal member 130 is moved, can prevent silk 132 take place do not wish the knot and the bending that occur.
As shown in Figure 4 and Figure 5, seal member 130 has locomotivity to increase structure, in order to increase the seal member 130 mobile required power in inner chamber 140 that promotes.Locomotivity increase structure is included in the ripple 138 near formation on the silk 132 of hermetic unit 136.Ripple 138 contacts with inner chamber 140 inner surfacies, and this has just increased makes silk 132 move the required frictional force that overcomes in inner chamber 140.In a most preferred embodiment, silk 132 is made by the NiTi nobelium, and external diameter is 0.006 inch, and inserts and have diameter and be about in 0.010 inch the NiTi nobelium conduit of inner chamber 140, in order to the ripple of the locomotivity that increases open valve, the wavelength of an one and a half-wave is about 0.016 inch on silk 132
Fig. 6 and Fig. 7 have shown an alternative embodiment of the invention.What Fig. 6 showed is a conduit 400 that aforesaid body 418 and dilating sacculus (not shown) are arranged.Except that particularly pointing out, conduit 400 can be made of above-described material and method, and its structure outward appearance also can be with aforesaid the same.Special feature is that as shown in Figure 6 and Figure 7, conduit 400 is the side opening on catheter tube not, does not also have the supporting retainer on silk and chamber.In fact, hermetic unit can be deviate from from the chamber fully.In case hermetic unit is deviate from, the cardinal extremity port just is used as the inlet of attaching device, is used for making balloon expandable or contraction.After inflated maintained expansion state, hermetic unit can insert in the chamber by the cardinal extremity port.
Conduit 400 has a cardinal extremity 412 and the terminal (not shown) that dilating sacculus is housed.One inner chamber 440 extends to end from cardinal extremity in body 418, the opening 423 in a chamber 440 is positioned at cardinal extremity 412 places of conduit 400.
Seal member 430 inserts chamber 440 by opening 423.Seal member 430 has 433, one tapered zones 431 of a main shaft and a rhizoid 432.Seal member 430 can be made with aforesaid any material and method.As shown in Figure 6 and Figure 7, the external diameter of main shaft 433 is less than the internal diameter in chamber 440, and this makes main shaft 433 insert chamber 440 smoothly.In addition, the external diameter of tapered zone 431 and silk 432 is also littler than the external diameter of main shaft 433, and just more less than the internal diameter in chamber 440, this just makes tapered zone 431 and silk 432 also can insert chamber 440 smoothly for that.As previously mentioned, the part of main shaft 433 is preferably stretched out from cardinal extremity 412, is beneficial to apply locomotivity to seal member 430, so that silk 432 moves in chamber 440.
As shown in Figure 6 and Figure 7, seal member 430 has locomotivity and increases structure, in order to increase the seal member 430 mobile required power in chamber 440 that promotes.Locomotivity increases structure and comprises ripple 438a and the 438b that forms near its end on the silk 432.Ripple 438a contacts with chamber 440 inner surfacies with 438b, and this has just increased makes silk 432 move the required frictional force that overcomes in chamber 440.In a most preferred embodiment, silk 432 is made by the NiTi nobelium, and external diameter is 0.006 inch, and inserts and have diameter and be about in 0.010 inch the NiTi nobelium conduit of inner chamber 440, in order to the ripple of the locomotivity that increases open valve, the wavelength of an one and a half-wave is 0.016 inch on silk 432
Chamber hermetic unit 436 coaxial being securely fixed on the silk 432.Hermetic unit 436 forms a fluid-tight with the external diameter of silk 432 and the internal diameter in chamber 440, and this just makes when hermetic unit 436 inserts chambeies 440, and the fluid by opening 423 inflow chambers 440 can not flow through hermetic unit 436.Hermetic unit 436 has been by having formed this fluid-tight with closely contacting in week in the closely knit part of hermetic unit 436 length directions and one section chamber 440 whole, and sealing part 436 can be with aforesaid material and method manufacturing.
In the embodiment of the seal member that can take out, as mentioned above, the discerptible hermetic unit of seal member neither one.In these embodiments, the function of seal member itself is as a hermetic unit, it can insert in order to stoping fluid flow from the cardinal extremity opening, and can partly or completely to take out be to form a fluid passage between an expansible element on cardinal extremity opening and the catheter tip.Preferably the seal member of these embodiment has a conical head, and this conical head inserts so that it can be used as plug at the intracavity diameter of its end external diameter less than conduit, and like this, the end of this conehead can insert catheter lumen by the cardinal extremity opening at an easy rate.The external diameter of this conehead increases to cardinal extremity gradually along its end, so, the external diameter at this conehead one place or several places is greater than with its internal diameter as the chamber of the conduit of plug, like this, by this conehead is pressed into the cardinal extremity opening, this conehead be split into fluid-tight than large outer-diametric portion at catheter-based end opening place and catheter lumen.An O type circle or other polymer architecture can be loaded into conduit cavity at the cardinal extremity opening part or near the cardinal extremity opening part, so that form a sealing with this conehead.So in this embodiment, this sealing that is produced can not be moved relative to conduit, and be fixed on the cardinal extremity opening part of conduit or near the cardinal extremity opening part of conduit.
Figure 12 has shown another embodiment of valve of the present invention.This embodiment has a conduit 500, and this conduit 500 is made up of a body 518 and a cardinal extremity 512 arranged.Conduit 500 has an opening 523 and the chamber 540 of extending along the body length direction at the cardinal extremity place.A chamber 540 and an expansion member (not shown) fluid communication that is contained on body 518 ends.On body 518, one side hand-hole 522 is arranged away from cardinal extremity 512 places.Conduit 500 is the same with aforementioned conduit aspect structure, size, material and structure.
Seal member 550 be positioned at chamber 540 near cardinal extremity opening 523 and side hand-hole 522 places.Seal member 550 is made up of short body 568, and this body 568 has a chamber 590, and 562 places sealing at one end, opens wide at other end place.The external diameter of seal member 550 is bigger slightly than the internal diameter in chamber 540, but littler than the external diameter of body 518, and like this, seal member 550 closely fits into chamber 540 by opening 523, to form fluid-tight at catheter-based end opening 523 places.Supporting stop component 550 (not shown) can install on seal member 550 and the conduit 500, to prevent that seal member 550 is deviate from when pressurizeing from chamber 540.Seal member can be used the material the same with body 518.
Body 568 is equipped with one and prolongs the opening 572 that passes through wherein.Opening 572 is positioned on the body 568, and like this, when seal member 550 rotated in chamber 540 or moves around, opening 572 can align with side hand-hole 522.Can load onto rotating element 595,, be beneficial to seal member 550 and in chamber 540, rotate as vertical connector.Known to the same domain person skilled in the art, other rotating elements also can be used as vertical connector as groove, chase.
Seal member 550 is as the valve in the conduit 500, controls by the fluidic of side hand-hole 522 to flow.When seal member 550 rotations made hole 522 align with opening 572, fluid can pass hole 522, through chamber 540, made the locking device expansion.Under required expansion state, sealing 550 can be rotated, as turn 90 degrees, or moves around in chamber 540, so that opening 572 no longer aligns with hole 522, like this, body 568 just stops fluid to pass through hole 522 outflows.
Figure 13 has shown another embodiment of rotary seal parts.The embodiment of Figure 12 has shown similar construction features.Label among this two embodiment is corresponding.Seal member 600 except do not have seal member 650 so big and be fit to slide on the body 618, structurally the seal member with Figure 12 is the same.Each diameter in body 618 and seal member chamber 690 can form fluid-tight on chamber 623.As mentioned above, by rotating or moving axially, inflation side hand-hole 622 can align with opening 672, enters chamber 640 so that fluid passes hole 622.
In some was implemented, as required, seal member 550 and 650 can be longer, so that they are as external part, can allow other conduit sleeve on conduit 500 and 600.In these embodiments, seal member 550 and 650 can be made up of longer body, or loads onto adnexa so that extension component is dismountable fixed thereon.
Figure 14, Figure 15 A and Figure 15 B have shown with the self-closing valve to be an alternative embodiment of the invention of characteristics.This embodiment comprises the elongated flexible body 718 and the sacculus (not shown) that extend to terminal function end (not shown) as described above from cardinal extremity control end 712.Body 718 has an inner chamber 740 that extends to end from cardinal extremity.There is an opening 723 in chamber 740 at cardinal extremity 712, and the other end is a fluid-tight.Side air-filled pore 722 is positioned at a bit locating away from opening 723 on the body 718.As previously mentioned, fluid is communicated with between air-filled pore 722 and chamber 740 and the terminal dilating sacculus.
Silk 732 inserts openings 723, and introduction chamber 740 smoothly.Correspondingly, the external diameter of silk 732 is less than the internal diameter in chamber 740, so that silk 732 can be put in the chamber smoothly.Hermetic unit 736 coaxial being installed on the silk 732.The pattern and the structural similarity of the hermetic unit described in hermetic unit 736 and Fig. 1-3.Hermetic unit 736 is contained on the silk 732 on the position away from air-filled pore 722, and forms fluid-tight with the external diameter of silk 732 and the internal diameter in chamber 740, can prevent fluid in the inflow chamber 740 hermetic unit 736 of flowing through like this.So because hermetic unit 736 is to be contained in the chamber 740 away from air-filled pore 722 places, then hermetic unit 736 is in the position of closing valve.
Among the embodiment shown in Figure 14-15b, body 718 is made by the material that certain retractility is arranged, like this, if the cardinal extremity 712 of body 718 is fixed on the end 750 of silk 732, and along direction away from end 712, impose on 718 1 axial forces of body, so, this elasticity body 718 will cause air-filled pore 722 towards the end direction displacement, and then, body 718 near cardinal extremity 712 places crack 711 can be arranged so that the strain of body 718 increases, thereby, the generation that acts on the body 718 is increased away from the axial force that air-filled pore 722 directions are shifted.Silk 732 can be fixed on the body 718, as bonding, welding, soldering or crimping by any method known to the same domain person skilled in the art.
In a most preferred embodiment, body 718 is made by the NiTi nobelium, and when the retractility that when cardinal extremity cuts out axial crack 711, has at least 8%.Shown in Figure 15 A, when not when body 718 applies any axial force, hermetic unit 736 is in chamber 740 on the position away from air-filled pore 722, and this makes fluid not make balloon expandable or contraction by hole 722.But, in case apply a axial force to body 718 towards end, and silk 732 is when being in the cardinal extremity position of body 718, body will stretch, shown in Figure 15 B, air-filled pore 722 will be being shifted towards end direction, so that hermetic unit 736 is positioned in the intracavity near hole 722.This will produce an expedite fluid passage between air-filled pore 722 and terminal sacculus, so the fluid by hole 722 makes balloon expandable or contraction.When removing axial force, the dilatation of body 718 will cause air-filled pore 722 to the cardinal extremity displacement, and hermetic unit 736 will be in the pass valve position again.
Fig. 8 and Fig. 9 A have shown an inflation adapter 200, and it can be used to inflate and open and close the pet-valve among Fig. 1-5.Inflation adapter 200 has a shell, and this shell is divided into upper and lower half shell 202,204, and they are preferably all made by metal, medical Merlon or other material.Two halves 202 and 204 is connected to each other by a pair of hinge 205 that is positioned on their sides, and like this as Fig. 8 and shown in Figure 9, this two halves shell 202 can separate or engage as concha Anodonta seu Cristaria with 204.Inflation adapter 200 is in application process, and a locker 230 can be locked into upper half shell 202 on the lower half shell 204.The locker 230 that locker 230 can have a dihedral guide lug 235 to be beneficial to two halves shell 202 and 204 is locked together cuts out.Also can load onto spring 209 is beneficial to adapter 200 and opens.
Close and locker 230 when pinning when the two halves shell, groove 240 separates upper half shell 202 and lower half shell 204.Groove 240 has enough width to hold the cardinal extremity of the top conduit that pet-valve of the present invention is housed that is described in detail.Joint 210 is positioned at above the upper half shell 202, has produced a filling channel 212 that ends at upper half shell 202 inwall upper sheds 285.Though other patterns of joint can replace the luer device at an easy rate as pipe, quick connector and Y shape connector, joint 210 is preferably with the standard luer adapter that can link on the external pressurized fluid source.
Sealing comprises a pair of pad 280 on the two halves shell 202 and 204 inner surfacies around the opening 285 that is positioned at.Pad 280 alignment, like this when two halves shell 202 and 204 covers and is pinned by locker 230, fluid-tight inflatable chamber of generation between the internal range that pad 280 limits.This fluid-tight inflatable chamber is connected by fluid between filling channel 212 and the joint 210, so that the pressure inflatable fluid seals inflatable chamber by joint 210 imported fluids that are connected on the external pressurized fluid source.And then pad 280 is preferably made by elastomeric material such as silicone, C-Flex (TM) and Pebax (TM), so that pad 280 forms fluid tight chamber with the catheter tube assembling that extends through pad 280 lateral margins.
An actuator 220 that is contained on upper half shell 202 outer surfaces.In Fig. 8 and embodiment shown in Figure 9, actuator 220 is controlled at the cam that is used to operate slide plate 283 on upper half shell 202 inner surfacies.Slide plate 283 moves around along a straight line of dividing opening 285 equally.When actuator 220 moved to primary importance, slide plate 283 moved to opening 285 along this straight line.When actuator 220 moved to the second position, slide plate 283 deviated from opening 285 along same straight line and moves.Corresponding slide plate 284 is arranged on the lower half shell 204, and when actuator 220 shift positions, plate 283 and 284 alignment are also moved together like this.In order to be beneficial to plate 283 and 284 collaborative moving, a pin 286 or other similar occlusion structure can make when adapter cuts out plate 283 and 284 removably be fixed.Plate 283 and 284 movable length preferably are adjusted to and can make hermetic unit in the valve be in that valve leaves or valve closes enough distances of the desired minimum of position.
Plate 283 and 284 all has coarse surperficial 290, is beneficial to plate 283 and 284 and the friction interlock of pet-valve main shaft portion.In most preferred embodiment, plate 283 and 284 is all made with silicone, and rough surface 290 comprises double wedge 291 and the groove 292 that is formed on every block of plate 283 and 284.Double wedge 291 and groove 292 are supporting, so that the double wedge on plate inserts groove on the counter plate when adapter cuts out.
Understand for convenient, come now the inflated operation of the conduit of Fig. 1-3 to be described inflation adapter 200.Actuator 220 moves to primary importance, so slide plate 283 and 284 is moved near opening 285.Open locker 230 subsequently, expose groove 240.It is half-open then to go up lower half shell 202 and 204, and will insert the inflation adapter with the conduit 10 that shrinks sacculus 20.As previously mentioned, conduit 10 has one to be positioned near the air-filled pore 22 at cardinal extremity 12 places and one from cardinal extremity 12 extended main shafts 33.The conduit 10 that has a pet-valve in the closed position is put in the groove 240 of half-open adapter 200, and conduit 10 and main shaft 33 are put into locker 271 and 272, so when half shell 202 and 204 is closed, air-filled pore 22 will be in the fluid-tight inflatable chamber of pad 280 formation, and the extension of main shaft 33 will be placed between slide plate 283 and 284 except cardinal extremity 12.Straight-line groove 298 and pressing plate 299 will be used for making things convenient for conduit and seal member alinement and prevent to use in their bendings or knot.
During enforcement shown in Fig. 9 B is fallen, when the labelling 260 that is provided on conduit 10 and the main shaft 33 aligns with the labelling 270 of inflation on the adapter 200, air-filled pore 22 will align with the fluid-tight inflatable chamber of adapter 200, and when conduit 10 and seal member 30 insertion grooves 240, main shaft 33 and slide plate 283 and 284 alignment.Labelling 260 and 270 can be formed by the marking, groove or indenture, and other any ways that valve is alignd with inflation adapter linear mark form.Best, the slit between the labelling 260 on conduit 10 and the main shaft 33 equates that with the space between locker 271 and 272 is approaching by putting labelling 260 into locker 271 and 272, conduit 10 and main shaft 33 will correctly be alignd like this in adapter 200.
In case main shaft 33 and air-filled pore 22 are correctly alignd in adapter 200, locker 230 just can be locked.Air-filled pore 22 just is in the fluid-tight inflatable chamber of pad 280 formation now, and main shaft 33 is placed between slide plate 283 and 284.The clinician just can be connected to the external pressurized fluid source on the joint 210 subsequently.
For making sacculus 20 inflation, the clinician moves to the second position with actuator 220 from primary importance, and slide plate 283 and 284 has been removed from opening 285.Because main shaft 33 is locked between plate 283 and 284 securely, the axial force that acts on the main shaft 33 spreads from cardinal extremity 12.The axial force that this acts on the main shaft 33 causes silk 32 part from inner chamber 40 to be extracted out, and the hermetic unit 36 on the silk 32 will move on the inner chamber 40 interior positions near air-filled pore 22 like this.Hermetic unit 36 is moved to locational this move operation near air-filled pore,, opened pet-valve by between air-filled pore 22 and sacculus 20, setting up unimpeded fluid passage.
The external pressurized fluid source can pressurize subsequently, as by pressing the piston on the syringe, so that pressure fluid passes through passage 212 and opening 285, enters the fluid-tight inflatable chamber.Then pressure fluid makes sacculus 20 inflations by air-filled pore 22 and inner chamber 40.
By closing pet-valve, can make the sacculus 20 of expansion not have still to keep expansion state under the situation of source of pressurised fluid.This point is to get back to primary importance by mobile actuator 220, causes that slide plate 283 and 284 shifts to that opening 285 realizes.The plate that moves has applied an axial force towards cardinal extremity 12 to main shaft, causes silk 32 to be inserted inner chamber 40 further.Therefore, hermetic unit 36 moves to inner chamber 40 interior positions away from air-filled pore 22 from inner chamber 40 interior positions near air-filled pore 22.The fluid-tight that hermetic unit 36 produces is enclosed in pressure fluid in inner chamber 40 and the sacculus 20, and this just makes sacculus 20 maintain expansion state.The external pressurized fluid source can release and is taken away subsequently.In case pet-valve is closed, inflation adapter 200 can be taken away by opening locker 230, simultaneously conduit 10 and main shaft 33 are shifted out from groove 240.
The inflation adapter of Figure 10 and another embodiment shown in Figure 11, though also can be used for side hand-hole embodiment, it is particularly suitable for operating movably pet-valve.Adapter 300 has an outer sleeve 320 of being made by metal, medical Merlon or similar material.Outer sleeve 320 is overlapping the inner chamber 350 that diminishes gradually.Chamber 350 355 diminishes gradually from major diameter part 352 to small diameter portion, and major diameter part 352 is obviously bigger than the catheter tube external diameter that inserts chambeies 350, and small diameter portion 355 is bigger slightly than this catheter tube external diameter.Chamber 350 is connected with filling channel 312 fluids that joint 310 forms, and makes the pressure inflatable fluid can enter chamber 350.Each end in chamber 350 is all being adorned dismountable sealing 315, and this makes when source of pressurised fluid connects, can produce a fluid-tight inflatable chamber in chamber 350.Removable seal 315 is any sealing known to the same domain person skilled in the art, as Toughy Borst adapter, haemostatic valve etc.Removable seal 315 also can be used for fixing any conduit and the seal member that inserts in the removable seal opening 325.
In the use, will seal 315 open after, conduit shown in Fig. 6-7 and seal member just can insert opening 325.This conduit and seal member are positioned at below the fluid passage 312, and seal member can take out from the cardinal extremity opening of conduit.Between the terminal expansible element of catheter-based end opening and conduit, formed the fluid passage like this.Sealing 350 is shut and is produced a fluid tight chamber, and can produce a vacuum and/or pressure fluid makes balloon expandable or contraction.After desirable expansion or shrinking generation, by the manual or removable actuator (not shown) that unloads, the cardinal extremity opening that seal member is inserted conduit comes annular seal space.Sealing 350 subsequently can take off, and this just can be outwards sliding from an end of conduit and seal member with adapter, thereby the tunnel ends of adapter 300 is shifted out.
Be appreciated that the same domain person skilled in the art can propose some variation of the present invention voluntarily.But these variations are included within the spirit and scope of appended claims of the present invention.

Claims (29)

1. valve is characterized in that it comprises:
A flexible elongate tube body, it has a cardinal extremity and an end, and one extend to terminal inner chamber from cardinal extremity, and this inner chamber has an opening at cardinal extremity;
Expandable member at the body end, this expandable member keeps fluid to be communicated with inner chamber;
Inlet on body, this inlet is communicated with cavity fluid, to allow by making the expandable member expansion in the inlet pressurization;
A seal member, it has a hermetic unit that is used for the sealed tube body surface, the described hermetic unit of sealing parts can move between the two positions with respect to described body surface, one of them position, hermetic unit is positioned at and contacts with the body surface and stop fluid to flow into by inlet or flow out the position of expandable member with the expansion of keeping expandable member, in another position, hermetic unit is positioned at and allows fluid to flow into by inlet or the outflow expandable member, so that the position that makes the expandable member expansion or shrink.
2. valve according to claim 1, it is characterized in that, some cardinal extremity from body of seal member stretches out, apply axial force at extension to cardinal extremity, hermetic unit is moved to cardinal extremity at intracavity, apply adterminal axial force at extension, hermetic unit is moved at the intracavity terminad.
3. valve according to claim 1 is characterized in that its hermetic unit is made by polymeric material.
4. valve according to claim 3 is characterized in that, the part material of its hermetic unit is by from comprising Pebax (TM), and the material of selecting in one group of material of C-Flex (TM) or silicone is made.
5. valve according to claim 1, it is characterized in that, its hermetic unit can bear and reach 10 atmospheric pressure, and when hermetic unit is in position away from inlet, can stops any fluid to flow to by the side entrance in fact fully or flow out inflatable balloon.
6. valve according to claim 5, it is characterized in that, its hermetic unit can stand No. 10 switches circulation of valve under 10 atmospheric pressure, when hermetic unit is in position away from inlet, still can stops any fluid to flow to by inlet fully or flow out sacculus.
7. valve according to claim 1 is characterized in that, it is to be made by NiTi nobelium, rustless steel, Elgiloy (TM) or its mixture that its seal member has a part at least.
8. valve according to claim 1 is characterized in that, the external diameter of its body is greater than any part of seal member or the external diameter of hermetic unit.
9. valve according to claim 8 is characterized in that, the external diameter of its body is not more than 0.038 inch.
10. valve according to claim 9 is characterized in that, the external diameter of its body is not more than 0.020 inch.
11. valve according to claim 10 is characterized in that, the external diameter of its body is not more than 0.014 inch.
12. valve according to claim 1 is characterized in that, it also comprises a stop component, deviates from from opening part to prevent seal member.
13. valve according to claim 2 is characterized in that, also comprises a reinforcement structure, it can increase and is applied to assign to axial force that hermetic unit is moved of extension.
14. valve according to claim 1 is characterized in that, also comprises an inflation adapter that can hold valve, this inflation adapter has a fluid tight chamber, makes the expandable member expansion in order to import pressure fluid.
15. valve according to claim 1 is characterized in that, its inlet comprises that one is positioned on the body, near the side hand-hole of body end.
16. valve according to claim 1 is characterized in that, its inlet is the opening of inner chamber.
17. a device is characterized in that it comprises:
Wire guide with hollow of an inner chamber and a side air-filled pore that is communicated with inner chamber maintenance fluid;
An inflatable balloon that is contained on the seal wire, inflatable balloon is communicated with cavity fluid, and like this, the fluid that imports through the side hand-hole can be used for to inflated;
A valve that is slidingly installed along the surface of seal wire, described valve can move between first and second positions, and inner chamber is sealed in one of described position, makes any fluid all can not pass through the side hand-hole, flows to from inflatable balloon or flows out.
18. device according to claim 17 is characterized in that, the excircle of hollow seal wire has determined first valve, and wherein the circumference of removable valve less than first valve.
19. device according to claim 18 is characterized in that, the excircle of hollow seal wire is 0.044 inch or littler.
20. device according to claim 17 is characterized in that, the not obvious diameter of the diameter of removable valve greater than the hollow seal wire, wherein said valve seal the inner surface of described hollow seal wire.
21. a pet-valve is characterized in that, comprising:
A seal member can slide by the cardinal extremity opening of conduit and insert the inflatable chamber of conduit, and this conduit has a side inflation hand-hole and an inflatable balloon that is communicated with side inflation hand-hole fluid;
Hermetic unit on seal member, hermetic unit can form fluid-tight with the whole circumference of one section inner chamber, thereby any fluid all can not flow through hermetic unit;
Wherein when sealing partly is arranged in inner chamber near the position of side inflation hand-hole, between side inflation hand-hole and sacculus, set up a unimpeded fluid passage, when hermetic unit was positioned at inner chamber away from the position of side inflation hand-hole, any fluid all can not flow into or flows out inflatable balloon through side inflation hand-hole.
22. the method for a catheter-balloon inflation is characterized in that, may further comprise the steps:
A pipe is provided, and this Guan Youyi cardinal extremity and an end, its cardinal extremity have a fill opening to come to the inflatable chamber inflation, and its end has an inflatable balloon, keep fluid to be communicated with inflatable chamber;
Import the pressurization aerated fluid by fill opening, give inflated; And
Under the prerequisite of the pressure that does not reduce pressure fluid, seal up fill opening by hydrodynamic reciprocating sealing parts in inflatable chamber, wherein Mi Feng step is not finish under the situation to inflating balloon venting;
After finishing the sealing step, reduce the pressure of pressure fluid.
23. a low profile catheter valve that uses with the inflation adapter is characterized in that, comprising:
Conduit with a fill opening is used for to inflating with the inflatable element of inflatable open fluid communication;
One movably is assemblied in supravasal seal member, is used for stoping selectively between fill opening and inflatable element fluid flow;
Labelling at least one described conduit and described seal member when the label alignment on described labelling and the corresponding inflation adapter, will make fill opening to going into to inflate the fluid-tight inflatable chamber in the adapter.
24. an inflation adapter that is used for aerated fluid is imported the air-filled pore on the elongated tubular is characterized in that, comprising:
Shell with clip position, this clip position interact can the described pipe of dismountable clamping one section, and described shell has a chamber that holds described air-filled pore, and described shell also comprises:
An inlet, being used to connect to provide the aerated flow of described pressure fluid body source;
A sealing is used for the described part of described shell removably is sealed, and described sealing provides a fluid passage between described inflation inlet and described air-filled pore, and therefore, described pressure fluid offers described air-filled pore; And
An actuator that is contained on the described shell is used for driving an element of described pipe, controls the fluid described air-filled pore of flowing through.
25. inflation adapter according to claim 24 is characterized in that, described sealing by alignment with contact first and second pads and form.
26. inflation adapter according to claim 24 is characterized in that, it also is included in the labelling on described elongated tubular and the described shell, and described labelling is convenient to aim at described air-filled pore and described chamber.
27. inflation adapter according to claim 24 is characterized in that, described actuator is used for controlling the slide plate that drives described tube elements.
28. an inflation adapter that is used for aerated fluid is imported the air-filled pore of elongated tubular is characterized in that it comprises:
A shell comprises top and the lower part that can open assembling relatively, so that hold one section described pipe that comprises air-filled pore, described shell has an inflatable chamber and an inflation inlet that is used for the aerated fluid of pressurization is imported described inflatable chamber, described inflatable chamber removably is sealed to described air-filled pore on the described inflation inlet, so that form the fluid passage between them there.
29. an inflation adapter is used for aerated fluid is imported the elongated tubular air-filled pore, an inflatable part is housed on this slender conduit and an inflatable chamber between air-filled pore and inflatable part is arranged, and it is characterized in that described inflation adapter comprises:
One is used to seal the shell that described pipe forms the fluid-tight inflatable chamber, described shell has an inflation inlet and sets up a fluid passage so that make the inflatable part inflation between inflation inlet and air-filled pore, and described shell can never make on the described pipe of the inflatable part venting of having inflated and pull down.
CN 97196352 1996-05-20 1997-05-19 Low profile catheter valve Pending CN1225027A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 97196352 CN1225027A (en) 1996-05-20 1997-05-19 Low profile catheter valve

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/812,139 1997-03-06
US08/650,464 1997-03-06
CN 97196352 CN1225027A (en) 1996-05-20 1997-05-19 Low profile catheter valve

Publications (1)

Publication Number Publication Date
CN1225027A true CN1225027A (en) 1999-08-04

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Application Number Title Priority Date Filing Date
CN 97196352 Pending CN1225027A (en) 1996-05-20 1997-05-19 Low profile catheter valve

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CN (1) CN1225027A (en)

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US9351873B2 (en) 2003-11-14 2016-05-31 Transcend Medical, Inc. Ocular pressure regulation
US9421130B2 (en) 2006-01-17 2016-08-23 Novartis Ag. Glaucoma treatment device
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US9789000B2 (en) 2006-01-17 2017-10-17 Novartis Ag Glaucoma treatment device
US9421130B2 (en) 2006-01-17 2016-08-23 Novartis Ag. Glaucoma treatment device
US11786402B2 (en) 2006-01-17 2023-10-17 Alcon Inc. Glaucoma treatment device
US10905590B2 (en) 2006-01-17 2021-02-02 Alcon Inc. Glaucoma treatment device
US11839571B2 (en) 2009-01-28 2023-12-12 Alcon Inc. Ocular implant with stiffness qualities, methods of implantation and system
US11344448B2 (en) 2009-01-28 2022-05-31 Alcon Inc. Ocular implant with stiffness qualities, methods of implantation and system
US10531983B2 (en) 2009-01-28 2020-01-14 Novartis Ag Ocular implant with stiffness qualities, methods of implantation and system
US9763828B2 (en) 2009-01-28 2017-09-19 Novartis Ag Ocular implant with stiffness qualities, methods of implantation and system
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US10912676B2 (en) 2012-04-24 2021-02-09 Alcon Inc. Delivery system for ocular implant
US9907697B2 (en) 2012-04-24 2018-03-06 Novartis Ag Delivery system for ocular implant
US9480598B2 (en) 2012-09-17 2016-11-01 Novartis Ag Expanding ocular implant devices and methods
CN102921094A (en) * 2012-10-23 2013-02-13 湖南埃普特医疗器械有限公司 Endovascular dilation guide wire and preparation method thereof
US9763829B2 (en) 2012-11-14 2017-09-19 Novartis Ag Flow promoting ocular implant
CN104043187B (en) * 2013-03-11 2017-07-07 柯惠有限合伙公司 Control conduit flowing
US9463300B2 (en) 2013-03-11 2016-10-11 Covidien Lp Controlling catheter flow
CN104043187A (en) * 2013-03-11 2014-09-17 柯惠有限合伙公司 Controlling Catheter Flow
CN106691630A (en) * 2013-03-14 2017-05-24 斯波瑞申有限公司 Valve loading method, system, and apparatus
CN107980007A (en) * 2015-04-09 2018-05-01 波士顿科学国际有限公司 Capture foley's tube with capture sacculus retainer
CN109715242A (en) * 2016-07-13 2019-05-03 波士顿科学国际有限公司 Infusion catheter with high pressure ability
CN109715242B (en) * 2016-07-13 2021-08-20 波士顿科学国际有限公司 Infusion catheter with high pressure capability
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