CN1822877A

CN1822877A - Haemostatic valve assembly with indicator

Info

Publication number: CN1822877A
Application number: CNA2004800204107A
Authority: CN
Inventors: 埃里克·安德森; F·比尔克彼泽森
Original assignee: Cube Medical AS
Current assignee: Cube Medical AS
Priority date: 2003-06-17
Filing date: 2004-06-17
Publication date: 2006-08-23
Also published as: CN1822876A; CN1822878A

Abstract

The present invention is one hemostasis valve assembly connector, which has one longitudinally extending main section, one longitudinally extending through passage in the near end to the main section of the connector and one valve. The valve has one opened state and one closed state, and when the valve is in its opened state, one slender member may be inserted into the passage. The valve includes one indicator for indicating the state of the valve, and may also include one valve opener capable of being shifted longitudinally along the outer surface of the main section in the connector. The valve has its state altered through shifting the valve opener relatively to the main section, and the colored member may be seen through the valve opener when the valve is in opened state or closed state.

Description

The haemostatic valve assembly of band indicator

Technical field

The present invention relates generally to be used for the field of connectors of haemostatic valve assembly, as used at angioplasty for example.A kind of elongate members as a kind of balloon catheter or a kind of intravascular stent, can be inserted in the biological vascular system by adapter, and above-mentioned adapter comprises that is used for a safe hemostatic haemostatic valve.Especially, the invention provides a kind of mechanism, described mechanism is used to reduce the danger for the treatment of to insert by valve the device generation damage of vascular system.

Background of invention

Operation need enter biological as a cardiac's vascular system, such as being used to insert balloon catheter or mounting system as during angioplasty in blood vessel.Usually, inlet is to provide by a kind of adapter, and described adapter is such as providing and being connected of guiding catheter, and adapter so that an elongated implement can be inserted in the organism, and provides safe hemostasis in conjunction with a haemostatic valve simultaneously.The part of a side arm as this adapter can be set, so that being connected of a kind of and arm is provided, described arm is used for pressure detecting, contrast medium injection and/or normal saline washing.The adapter that has side arm is referred to as " y-shaped adapter " usually.Haemostatic valve guarantees that blood does not flow out adapter, and makes conduit, mounting system or arteriotomy apparatus can pass through adapter simultaneously.At the far-end of adapter, a rotatable Luer can be set, described Luer is used in the proximal end of catheter adapter being fastened to a corresponding member.

U.S. Patent No. 5,195,980 (David G.Catlin) disclose a kind of haemostatic valve that is included in the y-shaped adapter.Haemostatic valve is included in the sectional near-end of adapter master, and described adapter master segmentation comprises a rotatable Luer at its far-end.Side arm is bonded on the main segmentation between far-end and the haemostatic valve.Also disclose a kind of resilient valve element, described resilient valve element comprises a closed usually slit, and described slit is arranged to by an input pipe that passes its extension and opens.Another embodiment of haemostatic valve is from U.S. Patent No. 5,176, known among 652 (the Perry K.Littrell), the haemostatic valve of above-mentioned United States Patent (USP) ' 652 comprises two elastic washers, described two elastic washers have slit, this slit can allow elongate members run through, and slit runs through corresponding packing ring fully simultaneously, and each packing ring is tilted in relation to each other mobile.United States Patent (USP) ' 652 and U.S. Patent No. 4,798,594 (Richard A.Hillstead) also disclose the slit of spiral extension.

The coronary angioplasty technology generally discloses in the document below: Bernhard Meier shows, coronary angioplasty, Grune﹠amp; Stratton, the Inc. distribution, Harcourt BraceJovanovich publishes, and 1987.

Summary of the invention

Generally, the invention provides a kind of adapter, described adapter is used for a kind of haemostatic valve assembly, above-mentioned adapter comprises a vertical upwardly extending main segmentation, described main segmentation has a valve in its proximal end, valve has an open mode and a closure state, an elongate members can be inserted in the passage in above-mentioned open mode.Passing apparatus of adapter adding, such as the support of a conduit or application medicine and insert before the biological vascular system, operator should guarantee that such as the doctor valve suitably opens, because otherwise the outer surface of conduit or support has the danger of the valve member that nuzzles up, consequently damage the surface of apparatus, the pharmaceutical on the rack surface that accurately is arranged on the application medicine is lost.Yet if stipulated external environment condition as mental pressure especially, operator may not determine sometimes that valve was the open mode that is in it before attempting to insert apparatus by valve.After attempting passing the valve insertion apparatus of a closure, operator may always not recognized the surface that medicine has been swiped support or caused the fact damaged apparatus, and he can be after suitably opening valve, with the apparatus that for example damages now or have in its surface under the wrong drug dose situation, insert patient's blood vessel.This mode may seriously be damaged patient's health, and often causes the extra treatment of needs and prolong patient's hospital stays.Therefore, the purpose of the preferred embodiment of the present invention provides a kind of mechanism, and described mechanism is used to reduce the danger that the apparatus that makes the valve for the treatment of by adapter insert vascular system damages.

Therefore, the invention provides a kind of adapter that is used for haemostatic valve assembly, described adapter comprises a vertical upwardly extending main segmentation, described vertical upwardly extending main segmentation has the penetrating via of a vertical upwardly extending band valve in the proximal end of adapter, above-mentioned valve has an open mode and a closure state, in the described state of opening, an elongate members can be inserted passage, valve comprises an indicator that is used for the indicator valve state.Indicator can provide a kind of optics and/or tactile feedback to operator, so that operator is by seeing or can be easy to determine by the touch valve state of valve.

In a preferred embodiment, valve comprises a valve opening machine, and described valve opening machine can be in the vertical along the sectional outer surface displacement of adapter master, so the state of valve can change by valve opening machine is moved with respect to main segmentation.Valve opening machine, perhaps under other embodiment situation, the mechanism that other is movable, advantageously can be arranged near the indicator, described indicator can comprise optical facilities, above-mentioned optical facilities are used to be provided at the optical appearance of at least a portion adapter under the open mode, and this optical appearance is different with the optical appearance of that part of adapter under closure state.For example, valve can comprise an elastomeric closure member, as a kind of silicone member, above-mentioned closure member is arranged to the near-end at the closure state lower seal adapter of valve, valve opening machine comprises a puncture member simultaneously, described puncture member is extended with above-mentioned passage coaxial-type, and at least a portion is in above-mentioned channel interior.Puncture member can be arranged like this with respect to closure member, so that it passes closure member under the valve open mode, thereby elastomeric closure member is around the puncture member closure, and it does not pass closure member under the closure state of valve.This embodiment of valve extremely is suitable for the embodiment of valve opening machine, above-mentioned valve opening machine comprises a transparent part and an opaque section, and wherein the main segmentation of adapter comprises a colored segmentation in its proximal end, when valve is in open mode, above-mentioned colored segmentation is covered by the opaque section of valve opening machine, and when valve was in closure state, colored segmentation can be seen by transparent segmentation.Therefore, for example, when valve was in closure state, colored segmentation can be clear that by operator, and when valve was shown in an open position, colored segmentation was covered fully.Therefore, a kind of superficial and quick quick glance just can make operator determine the state of valve at the valve place.Preferably, the proximal end face of valve opening machine is opaque, so operator is not passed proximal end face in colored segmentation under with concealed the sort of valve state and seen coloured sectional danger.

Although be not preferred, but a kind of what is called can be set, and ' Touhy Borst ' valve is as haemostatic valve, and described ' Touhy Borst ' valve itself is known, and it comprises a kind of elastica with opening, conduit runs through described opening, and by swivelling cover around the conduit periphery with the opening closure.Yet from viewpoint easy to use, ' Touhy Borst ' design has individual shortcoming to be, it needs a conductor syringe needle that separates or pipe to pass valve to open film, the not damage so that insert conduit or support.Therefore, because insert and rubbing action and must keep the attention of support position on air bag when generally using intravascular stent (comprising air bag or expandable stent and self-expanding stent) to cause having increased an apparatus passed valve, so that so-called puncture valves has become is more popular.The example of this class puncture valves is those valves described in the relevant preferred embodiment of the present invention of this paper, in U.S. Patent No. 5,195, and disclosed valve and in U.S. Patent No. 5,176 in 980, illustrated valve in 652.

Adapter comprises an embodiment who is used for adapter is connected to the side arm on the arm, that is so-called ' y-shaped adapter ' embodiment, according to the present invention, can be included in the tool set, described tool set also comprises a side arm tube, described side arm tube is used for side arm and piston of possibility, as the standard stop,threeway.Side arm can be such as providing being connected of a kind of and an arm, and above-mentioned arm is used for pressure monitoring, contrast medium injection and/or normal saline washing.Side arm can be arranged to and receive the pipeline that makes side arm and piston interconnection.

In one embodiment, adapter can comprise a main segmentation, and described main segmentation is made with the part of two common extensions that separate, and these two parts interconnect mutually or engage, and two parts are preferably made of plastic.When interconnecting, two parts can bearing certain pressure such as injection pressure in a vertical passage, and above-mentioned vertical passage extends in inside, and is limited by the inner surface of described two parts.Have now found that being difficult to manufacturing sometimes between two parts that separate of an adapter is interconnecting of gummed basically,, bear certain pressure so that the adapter of finishing is sure because perhaps it be not easy to control process for making exactly.Therefore, be desirable to provide a kind of adapter that is used to comprise the haemostatic valve assembly of two separate parts, and guaranteeing a kind of uncomplicated relatively and low process for making of cost simultaneously, above-mentioned adapter does not rely on glue as two interconnective single or main means of parts.Therefore, the main segmentation of longitudinal extension can have a proximal part and a distal part, described proximal part and distal part respectively have a vertical upwardly extending penetrating via, adapter also comprises and is used to provide the mechanism that connects between proximal part and the distal part, thereby, when interconnecting, distal part and proximal part are extended in a longitudinal direction jointly, bindiny mechanism comprises an extension, one of them of described extension and above-mentioned proximal part and distal part becomes integral body, and be suitable for engaging wherein another recessed portion, so that above-mentioned nearside and distal part interfix in a longitudinal direction.Like this, because between proximal part and the distal part is mechanical connection basically, so adapter can be used for bearing the internal pressure of a regulation, the internal pressure of described regulation can accurately be calculated according to the size of the material technology specification of making two parts and each parts.Except the mechanical mechanism that when interconnecting, is provided, interconnect and can strengthen with glue, but, in the preferred embodiment of the present invention, adapter is to assemble under the situation without glue.Preferably, be interconnected to form and be that a kind of latch-type connects, such as from fixed springlock.In a preferred embodiment of the invention, extension is a kind of barbed part.Barbed part can for example provide the part as first parts neighboring in above-mentioned two parts, and its size makes it can surround the end portion of another parts in two parts at least in part.Therefore the part of surrounding can provide a flange or the collar such as the transition part office between a minor diameter segmentation and major diameter segmentation, and the above-mentioned flange or the collar can engage the agnail part.There is the agnail part preferably to comprise several agnails of arranging along first parts periphery.Can slide on second parts for the agnail part of having that makes first parts, it can be flexible in the radial direction that the agnail part is arranged, and that it does not preferably have in a longitudinal direction is flexible or flexible very little at least.This footpath flexible can the providing that make progress by being arranged in first ends vertical upwardly extending slit.In one embodiment of the invention, the end of distal part is suitable for putting into the end of proximal part, have agnail partly to be arranged on the close end office of distal part, recessed portion comprises a collar portion that is arranged on the proximal part outer surface, such as a sharp edge collar portion.In another embodiment, have the agnail part can be arranged on the place, an end of proximal part, an end of distal part can be laid in described end.

For preclude blood and/or other fluid flow out adapter at the place of interconnecting, a sealing mechanism can be set at the place of interconnecting.This sealing mechanism can comprise a resilient member, enclose as O shape, when proximal part and distal part interconnect, above-mentioned resilient member for example is clamped between two parts like this, so that it be assemblied in around and the outer sleeve part of two parts invading the interior of tight closure face component and in the inner sleeve part of mounted inside and two parts China and foreign countries of tight closure face component.

Interconnecting can be like this, so that distal part and proximal part can rotate relative to one another around an axis that extends in a longitudinal direction, such as, if two parts one of them or the two be threaded part and be used to engage the screw thread of a respective members such as guiding catheter, then above-mentioned this rotation is desirable.In a preferred embodiment of the invention, distal part constitutes a rotatable Luer, does not therefore need to make a Luer as the parts that separate.First has screw thread or has slot part can be arranged on the outside of distal part and may be on the wall of taper, and second have threaded portion can be arranged on the inner surface of distal part, under latter event, when present dynasty one sees in the radial direction, run through on having threaded portion to be arranged on to surround vertically between the outer wall of annular wall and distal part encirclement of passage of adapter.

The distal part of adapter and proximal part can be by a kind of plastics manufacturings of injection moulding.

Some preferred embodiments according to adapter of the present invention comprise closure member, so that provide a kind of effective seal between passage in adapter and the atmosphere on every side, especially in the sealing of adapter proximal end, conveniently insert a conduit or mounting system usefulness and can supply to pass closure member simultaneously.In one embodiment, closure member comprises a closure member, the sectional proximal end face of the plane butt connector master of described closure member.For a kind of positiver sealing at adapter master segmented peripheral place is provided, the main sectional proximal end face of closure member plane butt joint, one of them of above-mentioned plane and end surfaces has a projection, and described projection is used for engaging and is arranged on one of them respective dimple of face/surface.Should be appreciated that and compared by traditional sealing that faced washer provided, projection and pit provide another sealing.In a preferred embodiment, closure member is made with a kind of elastomeric material, and when the plane of enclosed elastic spare offset relative to each other with main sectional end face, above-mentioned elastomeric material was suitable for being out of shape in the zone of projection/pit.Therefore, the passage outer circumference at its near-end provides a kind of liquid-tight sealing.Preferably, angle of projection and indentation extend over is 360 °, and therefore sealing is effective along main sectional whole end surfaces.Projection and pit preferably extend along the whole peripheral part such as closure member.Projection can form the integral part of closure member, and it can extend along that the surperficial peripheral part towards the connector end surface.Preferably, projection is extended in a longitudinal direction, that is crosses the plane extension of its end surfaces.Projection can be taper, so it is wideer than far-end in its proximal end.Closure member can limit a core segmentation, and described core segmentation can be assemblied in the interior vertical passage of adapter.The core segmentation can be taper, so its diameter is big at its far-end at its proximal end ratio.

Closure member can be made with a kind of elastomeric material, and comprises a slit, and described slit extends between two facing surfaces.Slit is shaped, a kind of closure member with positiver sealing is provided when running through closure member with convenient conduit or mounting system, perhaps when valve is in closure state, that is when not having conduit or mounting system to run through closure member, provide a kind of reliable sealing.More particularly, closure member can limit first and second end surfaces, and at least one passage slit, above-mentioned closure member is relative with first and second end surfaces, and above-mentioned passage slit is closed usually, and between two end surfaces, extend, passage slit is arranged to and runs through it by a tube-like piece and open, and passage slit has a length for greater than the length at the second surface place at the first surface place.In other words, in surface of closure member, the lateral length of slit is shorter at the lateral length of another surface of closure member than slit.Therefore, when conduit or mounting system were passed closure member, slit limited a conductor that is used for above-mentioned this system, inserted and became a specific theta alignment with closure member in the face of the conductor of closure member passes closure member to small part.In a preferred embodiment, closure member is a kind of washer-shaped member, and described washer-shaped member is made with a kind of resilient or elastomeric material, as making with silicone rubber or latex.Passage slit preferably forms like this, so that it limits first axis of symmetry on first surface, described first axis of symmetry is aimed at second axis of symmetry on the second surface, so conduit or mounting system keep vertical with the end surfaces of closure member basically when running through closure member.By a kind of aforesaid slit is provided, reduce conduit or mounting system and aimed at inappropriate danger with closure member, therefore and conduit or mounting system make the danger of closure member stretchings/distortion in slit areas reach this degree, consequently gap of generation between the outer wall of conduit or mounting system and closure member.

A plurality of passage slit can be set, and described passage slit limits one first shared contact point or cross point on first surface, and they directly upwards stretch out from the contact point of first surface.For example, 3 slits can be set, described 3 slits directly upwards stretch out from contact point, and 4 slits perhaps can be set, and described 4 slits are arranged to and form a kind of cross.On second facing surfaces, each slit preferably limits one second shared contact point, and each slit is than short at the first surface place basically at the second surface place.Preferably, be 1/10 of first surface place slit length at least in the length of each slit of second surface place, more preferably at the most 1/20.In fact, each slit extends a length and is close to zero at the second surface place, so meets in their points on second surface, and above-mentioned point preferably is arranged in central authorities with respect to the surface.

Pass closure member for convenience and insert a conduit or mounting system, among first and second end surfaces one as second end surfaces at least a portion preferably can have a kind of concave.

In the time of in being installed in adapter, second end surfaces is preferably oriented to face the near-end of adapter.

Generally, adapter embodiment of the present invention can be used for assembling various supports, comprising, but be not limited to, Strecker support, Palmaz support, Wallstents, self-expanding formula Nitinol support are as Bard Luminex support, Symphohy support, Smart support and AVE SE support, Perflex support, AVE support, Intrastents, Instents, Herculink and Dynalink.Equally, adapter of the present invention can be used for assembling various conduits, comprising, but be not limited to Mainz balloon catheter, Monorail balloon catheter, PCTA (percutaneous transcoronary angioplasty) conduit, and ultrasound catheter.

Brief description

Further specify above-mentioned each side of the present invention referring now to accompanying drawing, wherein:

Fig. 1 illustrates according to the adapter first embodiment longitudinal sectional view of the present invention,

Fig. 2 illustrates the adapter of Fig. 1 and the parts decomposition side view of an associated piston,

Fig. 3 illustrates a valve longitudinal sectional view that is included in Fig. 1 and 2 adapter, and valve is in closure state,

The valve that Fig. 4 illustrates Fig. 3 is in open mode,

Fig. 5 illustrates the valve cutaway view of Fig. 3 and 4, and described valve comprises an indicator that is used for the indicator valve state,

Fig. 6 illustrates a colored member longitudinal sectional view in the valve indicator that is included in Fig. 5,

Fig. 7 illustrates according to the adapter second embodiment side view of the present invention,

Fig. 8 illustrates according to adapter the 3rd embodiment side view of the present invention,

Fig. 9 illustrates a kind of valve opening machine among the embodiment of Fig. 7 and 8,

Figure 10 illustrates interconnective longitudinal sectional view between proximal part of adapter of Fig. 1 and 7 and the distal part,

Figure 11 illustrates the distal part longitudinal sectional view of Figure 10,

Figure 12 illustrates the perspective view of Figure 11 proximal part,

The main segmentation that Figure 13 illustrates a kind of adapter has a pit at an one end surfaces place, is used for providing in the adapter proximal end sealing of extending on periphery,

Figure 14 illustrates a closure member end-view that is used to be installed in the adapter proximal end of Figure 13,

Figure 15 is the cutaway view of the embodiment of closure member of Figure 14,

Figure 16 is alternative embodiment cutaway view of closure member of Figure 14.

Accompanying drawing describes in detail

Understandable as the explanation from the following preferred embodiment of the present invention, all above-mentioned aspects of the present invention can comprise in one embodiment.

As illustrated in fig. 1 and 2, a kind of y-shaped adapter 100 comprises a proximal part 102 and a distal part 104, above-mentioned proximal part and distal part are extended in a longitudinal direction jointly, and assemble with end to end mode, simultaneously the distal portions 106 of proximal part 102 is put into the nearly part of distal part 104.Distal part 104 forms a kind of rotary thick head and revolves a mouthful lock, and described thick head revolves a mouthful lockset one first externally grooved or threaded portion 109 and one second internal whorl part 111.In each nearside and distal part, be provided with a vertical upwardly extending penetrating via 110 and 112 respectively.When assembling, proximal part and distal part limit a main segmentation 114 together.Between proximal part and distal part, interconnect the place, distal part limits an extension 116, preferably a kind of have an agnail part, upwards inwardly stretch out in above-mentioned extension 116 footpaths, and the recessed portion 118 of joint proximal part 102, the female part 118 is got a kind of collar shape, and the above-mentioned collar is limited by the external diameter transformation part of proximal part 102.Interconnect and to further specify with reference to Fig. 7-9 below.Extension 116 is shaped, so that provide distal part 104 snap locks on proximal part 102.When assembling, proximal part and distal part are clamped in an O shape circle between them, and described O shape circle is arranged on segmentation place that broadens of segmentation place that diameter reduces of proximal part and the corresponding diameter of distal part inner surface.Side arm 122 provides adapter 100 is connected on the arm (not shown), and described arm is used for pressure monitoring, contrast medium injection and/or normal saline washing.As shown in Figure 2, the connection from side arm 122 to arm can provide by a piston 124 and a side arm tube 126.

The adapter 100 of Fig. 1 comprises in its proximal end: a valve 128, and described valve 128 comprises an elastomeric closure member 130; A valve opening machine 132; With a puncture member 134, described puncture member 134 is shaped, so that an elongated passageway mouth is provided, described elongated passageway mouth is under valve closure state as shown in Figure 3, make the near-end of closure member energy seal channel 110, and under the open mode of valve, as shown in Figure 4, puncture member is passed elastomeric closure member 130, so that make a conduit or a support (not shown) can pass valve.Puncture member 134 becomes integral body with valve opening machine 132 shown in Fig. 3 and 4, above-mentioned valve opening machine 132 can be in the vertical along the outer surface displacement of proximal part 102, indicated as arrow among Fig. 1 138, so that when the proximal most position of valve opening machine, valve is in a kind of closure state, as shown in Figure 3, and when the highest distance position of valve opening machine, valve is in open mode, as shown in Figure 4.The indicator that is used for the indicator valve state comprises a colored member 136, sees Fig. 2.

Fig. 5 illustrates the valve cutaway view of Fig. 3 and 4, comprises an indicator that is used for the indicator valve state simultaneously.Indicator comprises a colored member 136, and described colored member 136 its colors can be such as being yellow or any other high saturation color.The nearest segmentation 140 of valve opening machine 132 is opaque, and the distal part 142 of valve opening machine is transparent.Therefore, when valve was in as shown in Figure 5 closure state, colored member 136 can be seen by transparent part 142.Yet when valve is shown in an open position, that is valve opening machine 132 is when being displaced to position shown in Fig. 4, the colored member 136 of opaque segmentation 140 stacks of valve, and above-mentioned then colored member 136 is that operator be can't see basically.For example, if colored member 136 has a kind of high saturated yellow, then when valve is in its closure state, operator can be seen immediately, thereby clearly expression is not attempted conduit or support are passed the valve insertion, and when valve is in open mode, will can't see yellow, thereby clearly expression, conduit or support can pass valve safely.Should be appreciated that valve can alternatively design like this, colored member can be seen when being in its open mode with convenient valve, and when valve was in closure state, colored member be can't see.

Colored member 136 is shown specifically in Fig. 6, obviously can find out from Fig. 6, an extension, as preferably one agnail part 144 is arranged, colored member 136 can be connected on the proximal part 102 of adapter by a springlock, not have longitudinal elasticity basically because there is agnail partly to show a kind of radial elastic.Radial elastic can be provided by vertical upwardly extending slit in the member 136, and these slits form basically has those slits 148 that provided in the zone of agnail part as adapter distal part 104, sees Fig. 9.As shown in Figure 5, proximal part 102 limits a recessed portion of getting the collar 146 shapes, when interconnecting with convenient member 136 and proximal part 102, has the agnail part firmly that member 136 is fixing with respect to proximal part 102.

Fig. 7-9 illustrates a kind of valve opening machine 133 alternative embodiment.Use the label identical to represent at described element aspect Fig. 1-6 above with same parts.Yet, should be appreciated that although in fact represent with identical label, the difference of structure may exist.The adapter 100 of Fig. 7-9 comprises an opaque valve opening machine 133, and described opaque valve opening machine 133 has a segmentation 135 transparent or that cut.A colored member (not shown) is provided, described colored member and top about Fig. 2,5 is similar or identical with 6 described colored members.When valve is in its distal position, that is when valve was opened, colored member can be seen by segmentation 135 transparent or that cut.Under the closure state of valve, that is when valve opening machine 133 was in its proximal position, colored member be can't see.Preferably, proximal end face 137 is opaque, and therefore colored member can not be seen by end surfaces.In some alternative embodiment, segmentation 135 also is opaque, and the medial section 139 of valve 133 can be transparent, and therefore under the open mode of valve or under closure state, colored member all is appreciable.In also having another alternative embodiment, segmentation 135 is transparent or cuts, and medial section 139 also is transparent.Fig. 8 illustrates a kind of adapter 101 that does not have sidewall.

Interconnecting between distal part and

proximal part

102 and 104, correspondingly based on and colored member 136 and proximal part 102 between interconnective same principle, as above with reference to Fig. 5 and 6 described.Like this, as shown in Figure 10 and 11, portions of proximal 102 has one agnail part 116 is arranged, the described collar 118 that has agnail part 116 to engage portions of proximal 102.An annular space 150 can be for O shape circle usefulness, and described O shape circle is not shown in Figure 10, but represents with label 120 in Fig. 1.Distal part 104 separately illustrates in Figure 11 and 12, also obviously can find out from Figure 11 and 12, the proximal part of distal part comprises some barbed parts 116, described have agnail part 116 to arrange along the periphery of distal part 104, and between them, has a slit 148, described slit 48 provides a kind of radial flexibility, and above-mentioned radial flexibility makes second parts 104 that have agnail part 116 can engage the collar 118 of proximal part 102 with the mode of snap lock.

Further specify the preferred embodiment of closure member now with reference to Figure 13-16, parts identical with element described in Fig. 1-12 in Figure 13-16 are represented with same label.Yet, should be appreciated that although use same label, architectural difference may exist.

Main segmentation 114 shown in Figure 13 has a proximal end face 152, and described proximal end face 152 limits a pit of getting groove 154 forms.Groove 154 is scheduled to hold the projection 158 that is arranged on the closure member 130, sees Figure 14-16.When closure member 130 during towards the surface 152 directions biasing of main segmentation 114, projection 158 is out of shape in groove 154, so that provide reliable sealing along end surfaces 152.Closure member 130 has three slits, and described three slits are represented with label 162 in the embodiment of Figure 15, and represented with label 164 in the embodiment of Figure 16.Slit 162,164 upwards stretches out from the first common contact point, 166 footpaths that are arranged on closure member 130 first surfaces 156.In the embodiment of Figure 15, each slit 162 has a length at first surface 156 places, and described length is substantially equal to their length at closure member second surface 160 places.Yet in the embodiment of Figure 16, each slit 164 has a length at second surface 160 places, and described length approaches zero, that is to say that three slits meet in one second contact point 168.In further embodiments, provide a concave portions 170, so that insert conduit or mounting system by closure member.

Above-mentioned adapter embodiment with reference to accompanying drawing operates as follows:

1. an arm (not shown) is attached on the adapter side arm 122.

2. the far-end with adapter is connected on the near-end of guiding catheter (not shown).

With the normal saline washing adapter so that remove bubble.The flushing of valve 128 is to carry out when valve is in open mode.

4. a pressure/input equipment (not shown) is attached on the arm.For avoiding sucking air, should guarantee that all connections are all firm.

5. the insertion guiding catheter is followed the guiding catheter of being recommended by guiding catheter manufacturing firm usually simultaneously and is inserted operation.

6. with a seal wire (not shown), perhaps a seal wire and a dilating catheter (not shown) insert in the adapter.When only inserting seal wire, should use a wire guide to insert the instrument (not shown), so that the top of protection seal wire.Can under the situation of not opening valve, insert a PTCA dilating catheter separately.Yet to any device greater than dilating catheter, as support, ultrasound catheter etc., valve all should be opened with valve opening machine 132.

7. follow then by the designed any operation of conduit or support manufacturing firm.

The size of adapter 100 preferred embodiments and other specification are as follows:

The internal diameter of narrow part: 2.4mm-9.0mm.

Be inserted into the maximum gauge of apparatus: 2.33mm-8.0mm.

Maximum pressure resistance with PTCA conduit and seal wire: 8Atm or at 1atm under the skin grafting dermepenthesis situation.

The maximum pressure resistance that does not have apparatus: 21Atm-2atm.

Metal inserts tool length: 10cm-2cm.

Metal inserts tool bore: 0.64mm-2.00mm.

First numerical value in above-mentioned numerical value interval relates to PTCA, and the second value in numerical value interval relates to AAA transplanting (the abdominal aortic aneurysm structural transplantation of percutaneous).

Claims

1. an adapter (100), described adapter (100) is used for a kind of haemostatic valve assembly, adapter (100) comprises the main segmentation (114) of a longitudinal extension, and described main segmentation (114) has the through hole (110 of a longitudinal extension in the proximal end of adapter; 112) and a valve (128), above-mentioned valve has an open mode and a closure state, a slender member can be inserted passage (110 in above-mentioned open mode; 112) in, above-mentioned valve comprises an indicator (136 that is used for the indicator valve state; 140; 142).

2. according to the described adapter of claim 1, it is characterized in that valve (128) comprises a valve opening machine (132; 133), described valve opening machine (132; 133) in the vertical can be along the outer surface displacement of the main segmentation (114) of adapter (100), so the state of valve (128) can be by making valve opening machine (132; 133) change with respect to main segmentation (114) displacement.

3. according to the described adapter of claim 2, it is characterized in that indicator (136; 140,142) comprise optical facilities, described optical facilities are used to be provided at the optical appearance of at least a portion adapter (100) under the open mode, and described optical appearance is different with the optical appearance of that part of adapter under closure state.

4. according to one of them described adapter of claim 1-3, it is characterized in that, valve (128) also comprises an elastomeric closure member (130), and described elastomeric closure member (130) is arranged to the near-end at the closure state lower seal adapter (100) of valve (128).

5. according to the described adapter of claim 4, it is characterized in that valve opening machine (132; 133) comprise a puncture member (134), described puncture member (134) and above-mentioned passage (110; 112) coaxial-type extension and at least a portion are at above-mentioned passage (110; 112) inside, and puncture member (134) is arranged with respect to closure member (130) like this, so that under the open mode of valve, penetrate closure member (130), thereby closure member (130) is around puncture member (134) closure, and it does not penetrate closure member (130) under the closure state of valve (128).

6. according to one of them described adapter of claim 2-5, it is characterized in that valve opening machine (132; 133) comprise a transparent part (135; 139; 142) and an opaque section (140), and the main segmentation (114) of adapter comprises a colored segmentation (136) in its proximal end, when valve is in open mode, above-mentioned colored segmentation is covered by opaque section (140), and being in closure state following time when valve, above-mentioned colored segmentation can be by transparent part (135; 139; 142) see.

7. according to the described adapter of claim 6, it is characterized in that, colored segmentation (136) is included in the colored member, described colored member is connected in the main segmentation (114) by a coupling part, above-mentioned coupling part has an extension (144), described extension (144) and above-mentioned segmentation (114; 136) one of them becomes integral body, and is suitable for engaging above-mentioned segmentation (114; 136) therefore another recessed portion (146) in makes two segmentations (114; 136) fastening mutually in a longitudinal direction.

8. according to one of them described adapter of claim 1-6, comprise a side arm (122), described side arm (122) is used for adapter (100) is connected to an arm.

9. according to one of them described adapter of claim 4-8, the proximal end face (152) of main segmentation (114), above-mentioned plane and end surfaces (152 are docked in a plane (156) of closure member (130) herein; 156) one of them has a projection (158), and described projection (158) is used for joint and is arranged on above-mentioned plane and end surfaces (152; 156) respective dimple (154) among in another.

10. according to the described adapter of claim 9, it is characterized in that closure member (130) is made with a kind of elastomeric material, when above-mentioned plane and end surfaces (152; When 156) offseting relative to each other, above-mentioned elastomeric material is suitable for being out of shape in the zone of above-mentioned projection and pit, so that at its proximal end passage (110; 112) provide a kind of liquid-tight sealing near the outer periphery.

11., it is characterized in that closure member (130) limits one first and second relative end surfaces (156 according to one of them described adapter of claim 4-10; 160) and at least one passage slit (164), described passage slit (164) is closed usually, and between two end surfaces, extend, passage slit is arranged to by a tube-like piece (134) and opens, described tube-like piece (134) passes above-mentioned passage slit and extends, passage slit (164) has a length at the first surface place, described length is longer than the length on the second surface.

12. according to the described adapter of claim 11, comprise a plurality of passage slit (164), described a plurality of passage slit (164) go up to limit one first common contact point (166) at first surface (156), and rolls over first make contact (166) from first surface (156) and directly upwards stretch out.

13., it is characterized in that a plurality of passage slit (164) go up at second surface (160) and limit one second common contact point (168) according to the described adapter of claim 12.

14. according to one of them described adapter of claim 11-13, it is characterized in that, at least one passage slit (164) has a length on second surface (160), described length is that passage slit goes up 1/10 of length at first surface (156) at the most.

15. according to one of them described adapter of claim 11-14, it is characterized in that, at least a portion first end surfaces (156) and at least a portion second end surfaces (166) limit two substantially parallel planes, and an axis that extends between the first and second shared contact points is substantially perpendicular to two planes.

16., it is characterized in that first and second end surfaces (156 according to one of them described adapter of claim 11-15; 160) at least a portion of one of them (170) is a concave surface.

17., it is characterized in that above-mentioned concave part (170) is arranged on the second surface (160) according to the described adapter of claim 13.

18., it is characterized in that closure member is arranged near the near-end of adapter according to one of them described adapter of claim 4-17.

19., it is characterized in that the second surface of closure member (160) is orientated the near-end towards adapter according to the described adapter of claim 18.

20. a tool set comprises that described side arm tube (126) is used for the side arm (122) of adapter according to one of them a described adapter (100) of claim 8-19 and a side arm tube (126).

21. according to the described tool set of claim 20, it comprises a piston (124), described piston (124) is connected on the end of side arm tube (126).

22. use a kind of indicator (136; 140; 142) indicate the closure or the open mode of a haemostatic valve (128), above-mentioned haemostatic valve (128) merges in the adapter (100) of a haemostatic valve assembly.

23. the use according to claim 22 is characterized in that, Application Optics mechanism (136; 140; 142) be provided at the optical appearance of at least a portion adapter (100) under the open mode, the optical appearance of that part of adapter is different under described optical appearance and the closure state.