CN100544787C - Pass the conduit system and the method for blood vessel embolism - Google Patents

Pass the conduit system and the method for blood vessel embolism Download PDF

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Publication number
CN100544787C
CN100544787C CNB2004800198816A CN200480019881A CN100544787C CN 100544787 C CN100544787 C CN 100544787C CN B2004800198816 A CNB2004800198816 A CN B2004800198816A CN 200480019881 A CN200480019881 A CN 200480019881A CN 100544787 C CN100544787 C CN 100544787C
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catheter shaft
sleeve pipe
conduit
assembly
far
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CN1822872A (en
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罗伯特·K·德克曼
埃里克·塞
埃米尔·R·阿吉拉尔
本亚明·J·克拉克
塞尔吉奥·萨利纳斯
丹尼尔·E·弗朗西斯
克特·D·斯帕克斯
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Lumend Inc
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Lumend Inc
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Abstract

Herein disclosed is the system and method that is used to form the original via of passing blood vessel embolism based on interposing catheter.Described conduit system generally comprises two assemblies.First assembly is a passivity subdivision conduit, and it comprises the manual driving member that is positioned at passivity subdivision distal end of catheter end, and described passivity subdivision conduit carries out passivity in blood vessel embolism cuts open, passes the subdivision road or the cat walk of thromboembolism with formation.Second assembly is a sleeve pipe, its as passivity subdivision conduit within it portion freely advance, the pipeline of rollback and rotation.First and second assemblies use with some combining form, to pass the blood vessel embolism in crown and the peripheral vascular system.

Description

Pass the conduit system and the method for blood vessel embolism
Related application
The application requires the U.S. Patent application No.60/477 that submits on June 10th, 2003, and 628 and the No.60/478 that submits on June 13rd, 2003,404 priority.
The application relates to the U.S. Patent application No.09/835 that is filed in April 13 calendar year 2001, and 043, be filed in the No.10/074 on February 12nd, 2002,546 and be filed in the No.10/647 on August 25th, 2003,904.The application also relates to the U.S. Patent application No.08/775 that is filed on February 28th, 1997, and 264, be filed in 8 days mandate U.S. Patent No. 5,968 of JIUYUE in 1998,064,09/149,847, be filed in the mandate U.S. Patent No. 6 on November 19th, 1999,508,825,09/443,924, be filed in the mandate U.S. Patent No. 6 on October 28th, 2003,599,304 and 09/538,441 with authorize U.S. Patent No. 6,638,247.
Technical field
System and method described herein relates to medical apparatus and instruments, more specifically relates to the system based on conduit for the treatment of human body or animal body vascular peg stay plug.
Background technology
Blood vessel embolism is remarkable or the mobile cardiovascular system of total blockage vascular inner blood (comprising heart and periphery vascular) obturation.Cause the course of disease development of blood vessel embolism to be commonly referred to as atherosclerosis, relate to fat, fiber and/or the calcified deposits thing deposition gradually of inside pipe wall along the pulse.This process can slowly take place, and needs several years sometimes.Blood vessel embolism can classify as " functional " or the chronic pathological changes of entirely shutting (CTO).Thromboembolism is functional, for example, blocks most of blood flow when vascular is developed to obvious stenosis, but still remains with the situation of little and limited path in the vascular.Thromboembolism classifies as CTO.
In arterial disease, usually when natural intravascular space begins slow closure, can reply by forming angiogenesis factor by become ischemia and health of the tissue of this natural vascularity, described angiogenesis factor impels near new " side pair " vascular that is created in the thromboembolism position to grow, for the tissue of thromboembolism far-end is sent nutrition.These new vasculars can help to stablize tranquillization or between minimum active stage tissue for the needs of blood flow and oxygen.Manyly in the crown and peripheral vasculature can produce these collateral vessels.Yet when taking exercise, these new collateral vessels can not be kept usually to tissue and carry enough blood and oxygen in the situation of big demand.For the periphery vessel occlusion of for example shank, the patient can progressively demonstrate the clinical symptoms such as lower limb lame (pain on motion), or when coronary vasodilator is inaccessible, and the patient can occur breathing hard when motion or the symptom of chest pain.
The naturopathy of blood vessel embolism can comprise interventional therapy (for example, non-operation, based on the method for conduit) or operation method.The purpose of interventional therapy is pass the initial cat walk of thromboembolism by at first producing, utilize balloon angioplasty to make by the vascular of thromboembolism the method that cat walk radial dilatation to diameter equals the green diameter of vascular before the thromboembolism on paper unobstructed again subsequently.Speckle rotary-cut (athrectomy) conduit and stent (stent) treatment also can be used in this position, and it is unobstructed for a long time to be beneficial to vascular.
Interventional therapy generally include the dedicated line that will be called leading line (guide wire) be incorporated into the approaching vascular of thromboembolism in, adopt fluoroscopic equipment to make leading line pass thromboembolism forward and enter the vascular of thromboembolism far-end.This basic fundamental can be applied to crown (heart) blood vessel and periphery (for example under ilium, femoral surface, the clavicle) blood vessel.In case leading line passes thromboembolism and enters thromboembolism distal vessels chamber, just can send balloon catheter through leading line, carries out balloon angioplasty at the thromboembolism position.
Yet the traditional direction line is not to be that to pass the path of whole thromboembolism designed for formation.On the contrary, it is designed to have very softish far-end, passes the blood vessel that does not block but narrow down to make it usually, thereby sends balloon catheter subsequently to carry out angioplasty at the tremulous pulse place that narrows down.The leading line that design can produce the path that passes whole thromboembolism is challenging work, although leading line must be enough tough to pass the obstructive material, if but leading line does not directly pass thromboembolism, leading line also wants enough soft make it can the penetration rate of blood tube wall.Yet, the path that leading line passes thromboembolism very likely departs from, and this is because the composition of whole thromboembolism may be very uneven, causes leading line influenced and deflection by fiber or hard calcified deposits thing, cause its possibility penetration rate of blood tube wall, this obviously is undesirable.
As mentioned above, the interventional method of the complete thromboembolism of treatment blood vessel can be challenging and problematic, and has high risk factor.Thereby the patient who suffers from the complete thromboembolism of blood vessel directly carries out the treatment of surgical method usually.Scheme as an alternative, the patient can attempt carrying out surgical method again after the failure getting involved usually.Although the surgical method obviously wound to the patient is bigger, the actual skill of this method is more direct, and it is owing to have less complication that this method generally is accepted.
In the surgical method, outer conduit is used for walking around thromboembolism, and wherein conduit one end connects the blood vessel of thromboembolism near-end, and the conduit other end connects the blood vessel of thromboembolism far-end.Like this, blood flow is walked around thromboembolism.Conduit can be tremulous pulse or venous outer planting part, perhaps can be artificial conduit, usually by the manufacturing of terylene (Dacron) compositions.
Yet surgical method neither not have complication.Though surgical method generally causes favourable clinical effectiveness, it is compared with interventional method has invasive very much, causes the longer convalescence of patient afterwards.Therefore, look back the surgical operation and the interventional method for the treatment of chronic complete thromboembolism, obviously wish to take non-operative treatment, and wish to take improved interventional therapy, this therapy can improve success rate and the minimizing complication relevant with this interventional method.
Description of drawings
Fig. 1 comprises passivity subdivision conduit (blunt dissection catheter) and telescopic conduit system according to an embodiment.
Fig. 2 a is passivity subdivision conduit and the sleeve pipe according to the vascular system medium vessels thromboembolism proximal end of an embodiment.
Fig. 2 b illustrates according to an embodiment, and sleeve pipe is retained in the blood vessel embolism proximal end and passivity subdivision conduit is passing blood vessel embolism.
Fig. 2 c illustrates according to an embodiment, and passivity subdivision conduit is passing blood vessel embolism.
Fig. 2 d illustrates according to an embodiment, and passivity subdivision conduit and sleeve pipe are passing blood vessel embolism.
Fig. 2 e illustrates according to an embodiment, and passivity subdivision conduit leaves blood vessel embolism, and sleeve pipe is stayed in the blood vessel embolism.
Fig. 2 f illustrates according to an embodiment, and passivity subdivision conduit and sleeve pipe have all passed blood vessel embolism.
Fig. 2 g illustrates according to an embodiment, and after removing passivity subdivision conduit, sleeve pipe remains on the position of passing blood vessel embolism.
Fig. 2 h illustrates according to an embodiment, and leading line passes sleeve pipe and enters the true chamber of thromboembolism distal vessels.
Fig. 2 i illustrates according to an embodiment, and after removing sleeve pipe, leading line is positioned at the position of passing blood vessel embolism.
Fig. 3 a is the conduit system that comprises sleeve pipe and overcoat conductor according to an embodiment.
Fig. 3 b is the longitdinal cross-section diagram according to the boot proximal end part of an embodiment.
Fig. 3 c is the longitdinal cross-section diagram according to the boot proximal end of an alternate embodiment.
Fig. 3 d is the longitdinal cross-section diagram according to the boot proximal end of another alternate embodiment.
Fig. 3 e is the longitdinal cross-section diagram according to the boot proximal end of another alternate embodiment.
Fig. 3 f is the longitdinal cross-section diagram according to the proximal end joint of an embodiment.
Fig. 4 a is the longitdinal cross-section diagram according to the conductor catheter adapter near-end of an embodiment.
Fig. 4 b is the longitdinal cross-section diagram that has the fluorescent labeling band and have the conductor distal end of catheter part of taper configurations according to an embodiment.
Fig. 4 c is the longitdinal cross-section diagram that has the fluorescent labeling band and have the conductor distal end of catheter part of circular structure according to an embodiment.
Fig. 5 a is the workpiece of passivity subdivision conduit that has two widening parts of Unclosing structure according to showing as of an embodiment.
Fig. 5 b is the workpiece of passivity subdivision conduit that has two widening parts of closing structure according to showing as of an embodiment.
Fig. 5 c is the exploded view according to the workpiece of the passivity subdivision conduit of an embodiment.
In the accompanying drawing, identical Reference numeral is represented identical or basic similarly parts or action.
The specific embodiment
System and method based on interposing catheter described herein is used to form the original via of passing the complete thromboembolism of blood vessel.It should be noted that system described herein does not carry out the treatment function, pass the original via of blood vessel embolism and be not used in the open or blood flow of function that recovers to lead to vascular because conduit system is formed.On the contrary, pass the path of thromboembolism in formation after, conduit system can be extracted out from vascular whole or in part.The path that is produced is used to pass the traditional direction line subsequently, and leading line is carried out the traditional function of delivery treatments device such as airsac tube or stent subsequently, so that the vascular site of thromboembolism is before carried out traditional angioplasty or stent plasty.Thereby the formation of original via only helps placing subsequently the traditional direction line, does not place the leading line that passes thromboembolism, and it is impossible further treating step.System described herein can be used for any vascular system in the body.
In the following description, introduce a large amount of details and understand the embodiment of this conduit system and method fully can illustrate and make the reader.But various equivalent modifications will appreciate that these embodiments can lack one or more details or implement with other assembly, system etc.In other example, not shown or unspecified well-known structure or operation are to avoid the feature of shelter disclosed embodiment.
Conduit system described herein generally comprises two assemblies.First assembly is a passivity subdivision conduit, comprises the remote manual driver part that is positioned at distal end of catheter, and it carries out the passivity subdivision passes thromboembolism with formation subdivision road or cat walk in blood vessel embolism.Second assembly is the sleeve pipe as pipeline, as passivity subdivision conduit within it portion can freely advance, the pipeline of rollback or rotation.The use that mutually combines of these assemblies is to pass the complete blood vessel embolism in crown and the peripheral vasculature.Being described as follows of each assembly.
Passivity subdivision conduit in embodiment comprises that far-end ends at the catheter shaft of work package (being also referred to as far-end driven unit or distal component), described catheter shaft comprises one or more vertical arrangements, atraumatic passivity expandable element, each expandable element has and is designed to the free distal end of rotating around the near-end that is hinged on the package base, and described pedestal is not removable and be connected in the catheter shaft far-end.Expandable element is by the long-range driving of catheter proximal end handle, and can advance at conduit, rollback and in blood vessel the appropriate location the normally closed position and carry out moving between the opening of passivity separation process, the activation point.In closed position, the free distal end of expandable element is towards the rotation of the central shaft of catheter shaft, and expandable element forms smoothly at the conduit the tip of the axis, the structure of passivity, bullet shape.In the structure of opening, the far-end of expandable element rotates around the near-end that hinge is connected to pedestal, and expandable element moves and laterally leave the central shaft of conduit with arc.
Driver part is positioned at the catheter shaft of embodiment, and the far-end of this driver part contacts with hinged expandable element, and the near-end of this driver part links to each other with the handle mechanism that near-end drives.For example, handle mechanism can be operated by the doctor.Apply axial force to driver part during driving handle, this axial force applies opening force (oPening force) to the expandable element of work package again.The work package response, wherein one or more are atraumatic, the passivity expandable element is connected to the near-end hinge through of pedestal around it, and the free distal end of expandable element moves and laterally leave the central shaft of conduit with arc.
When position during near blood vessel embolism, the vascular tissue that laterally moves blocking of far-end expandable element applies power, thereby destroys described thromboembolism on the spot, and produces little subdivision road at once at the work package far-end.Can in the little subdivision road, repeat said process to this to distal advancement with rear tube, all produce another little subdivision road at once each time, and conduit enter wherein at conduit work package far-end.Continue this process, advance by blood vessel embolism, and leave in the true chamber of blood vessel that thromboembolism enters the thromboembolism far-end until conduit.The passivity subdivision conduit of first assembly that can be used as described conduit system has been described in related application.
Second assembly of described conduit system is a sleeve pipe, and it is designed to the auxiliary device that passivity subdivision conduit turns round therein.Sleeve pipe in embodiment is flat (low profile) pipe, comprises single chamber, thin-wallconduit axle, and this far-end ends at atraumatic far distance port, and near-end ends at the single port joint.Telescopic wall thickness is wished thin as far as possible, and the internal diameter of sleeve pipe single chamber is designed to provide the high tolerance fit with passivity subdivision conduit external diameter.These two attributes provide the minimal overall profile of this composite conduit system, and this helps conduit system and advances and pass vascular system, and especially crucial is to help the serious symptom zone that blood vessel passes in system.
The outer surface of passivity subdivision conduit and telescopic inner surface are lubricated mutually, and this is because the annulus between two surfaces is minimized; This helps freely rotating and axially-movable of the interior passivity subdivision conduit of sleeve pipe.Realize that by in the internal surface of casing material, comprising lubriation material such as high density polyethylene (HDPE) (HDPE), low density polyethylene (LDPE) (LDPE) or polytetrafluoroethylene (PTFE) this is lubricated.The outer surface of passivity subdivision catheter shaft also can design with analog material or other polymer such as nylon or polyurethane, and can apply hydrophilic coating to increase lubricity to catheter surface.
Passivity subdivision conduit external diameter and the annular spaces between the casing inner diameter in embodiment are about 0.001 inch, but are not limited thereto.Casing wall thickness in embodiment is about 0.003-0.010 inch, but is not limited thereto.Nominal wall thickness is about 0.005 inch.Little annular gap between passivity subdivision conduit and the sleeve pipe combines with the wall thickness that minimizes of sleeve pipe especially end, makes to advance and above passivity subdivision conduit during translation leading edge minimum of its total exposure when conduit in vascular system.
On the program, comprise that passivity subdivision conduit and telescopic conduit system advance in blood vessel, closely contact with blood vessel embolism until the work package of passivity subdivision conduit.In this process, passivity subdivision conduit remains on the position that exceeds boot proximal end, exceeds about 1-15 centimetre usually.In order to carry out passivity subdivision process, utilize by the doctor and import the axial force of passivity subdivision conduit into through proximal handle, the work package of passivity subdivision conduit is applied to enough power in the blood vessel embolism.
Power is promoted by two factors from handle to the transfer of work package.First factor that promotes axial force to shift is the physical support that is provided by sleeve pipe.In itself, passivity subdivision catheter design is for having more flexibility, can easily pass vascular system.Yet, but the purpose that this design is considered also is to reduce the total amount of the inherence " promotion " that conduit self forms.Thereby the physical support that is provided by sleeve pipe has increased total " the promotion ability " of system.Second factor that promotes axial force to shift is the lubricity between internal surface of casing and the passivity subdivision catheter outer surface.The feasible transfer maximization that is passed to the power of passivity subdivision conduit work package of these two factors, and promote whole passivity subdivision process.
The maximization that is passed to the axial force transfer of passivity subdivision conduit work package is first basic function that sleeve pipe provides.The axial force that further transfer is imported by the doctor makes work package engage better with whole thromboembolism and promotes passivity subdivision process.When passivity subdivision conduit advances when passing blood vessel embolism gradually, sleeve pipe also can be in that program and patient are pushed ahead when suitable, so that provide suitable support to passivity subdivision conduit.Usually, telescopic far-end remains on the about 1-5cm distance of contiguous passivity subdivision conduit, so that suitable support to be provided.
When passivity subdivision conduit was advanced further to the angiemphraxis material, sleeve pipe also can be pushed ahead gradually.Along with the carrying out of this process, sleeve pipe will arrive the thromboembolism near-end, and the subdivision road begins to form herein.Until arriving this point, telescopic far-end can advance in the ill part of the diffusion of blood vessel always.Yet when arriving the blood vessel embolism near-end that the subdivision road begins, the working diameter of lumen of vessels will be decreased to the size in the subdivision road that is produced by passivity subdivision conduit.Now sleeve pipe is followed ability that passivity subdivision conduit enters from thromboembolism to distal advancement and is depended on the high tolerance fit between sleeve pipe and the passivity subdivision conduit and flat (the low profile) of sleeve pipe leading edge.Very flat sleeve pipe leading edge makes sleeve pipe follow above passivity subdivision conduit to enter in the subdivision road in the embodiment.
Because passivity subdivision conduit and sleeve pipe all advance by blood vessel embolism gradually, so passivity subdivision conduit finally leaves in the true chamber of blood vessel that blood vessel embolism enters the thromboembolism far-end.Thus, in this process, the position of passivity subdivision conduit is kept, and the further direction distal advancement on passivity subdivision conduit of sleeve pipe, also leaves thromboembolism until sleeve pipe, and enters in the true chamber of blood vessel of thromboembolism far-end.Subsequently, passivity subdivision conduit can be recalled in blood vessel and body fully, stays sleeve pipe and is positioned at the position of passing blood vessel embolism.
Now, the setting that sleeve pipe passes thromboembolism is used as pipeline easily, and wherein the traditional direction line can enter the true chamber of blood vessel of thromboembolism far-end through it.This is second basic function that sleeve pipe provides.After leading line being passed blood vessel embolism, keep its position, and sleeve pipe can be extracted out in blood vessel and body.Thereby leading line is stayed original position, so that delivery treatments apparatus such as balloon catheter or stent, thereby carries out angioplasty or stent plasty to treat the vascular site of previous thromboembolism.
Fig. 1 is the conduit system that comprises passivity subdivision conduit 100 and sleeve pipe 300 in the embodiment.Passivity subdivision conduit 100 and sleeve pipe 300 are expressed as the total system that passivity subdivision conduit 100 is positioned at sleeve pipe 300.Passivity subdivision conduit 100 has the active length longer than total physical length of sleeve pipe 300.Active length is defined as the length available of the catheter shaft that can enter another device usually, enters in the sleeve pipe 300 at this passivity subdivision conduit 100.Active length is the most proximal end on from the end of conduit amount to catheter shaft.In passivity subdivision conduit 100, active length extends to as the far-end of interface connecting duct axle 160 with the strain relief section 150 of handle 110 from work package 120.Passivity subdivision catheter shaft 160 can enter in the sleeve pipe 300, props up proximal end joint 310 until the strain relief section 150 of passivity subdivision conduit.When passivity subdivision conduit 100 entered in the sleeve pipe 300 fully, the distal portions 170 of passivity subdivision conduit stretched out from the far-end 330 of sleeve pipe 300.This length can change in the scope of about 1cm to 15cm usually, but is not limited thereto.The name outreach is about 10cm, but is not limited thereto.
The total length of the active length of passivity subdivision conduit 100 and corresponding sleeve pipe 300 depends on the health area that uses this system in the body, enter that region and conduit take arrive the path of thromboembolism through health.The therapentic part commonly used of peripheral vascular system is arranged in two main vessel branches, and promptly from active distal arteries and veins bifurcated, each bar blood vessel is all to torso area and one leg supply blood.Each iliac artery is tapered through groin and a strand upper area and enters femoral artery, and further is tapered and enters popliteal tremulous pulse in the knee area.
The position that typical conduit system enters peripheral vascular system is to be positioned at the inguinal femoral artery of side position.From this entry site, one that conduit system can be in the both direction is advanced.If thromboembolism is the tremulous pulse place at the entry site far-end, then conduit system is advanced to far-end and along blood flow direction, until arriving thromboembolism.This method is commonly referred to " homonymy (ipsa-lateral) ", and the same vessel branch that position and therapentic part are arranged in aortic bifurcation " the same side " is gone in fingering.Scheme as an alternative, if thromboembolism is arranged in the relative vessel branch of entry site, then conduit can use identical entry site, but at first contrary blood flow advances to the aorta end, enters the iliac artery branch of opposite side subsequently.Then, conduit can arrive thromboembolism to distal advancement.This method is commonly referred to as " offside (contra-lateral) ", because blood vessel embolism position and entry site are positioned at the offside shank of aorta bifurcated.
In that " " passivity subdivision conduit 100 required nominal active lengths are about 40cm-100cm to homonymy in the application, but are not limited thereto.The exemplary operation length of the passivity subdivision conduit 100 that homonymy is used is about 80cm.Therefore, nominally the total length of sleeve pipe 300 can be about 30cm-90cm, but be not limited thereto than passivity subdivision conduit 130 short about 10cm.
For offside was used, the conduit of passivity subdivision conduit 100 must be at first before entering the iliac artery of offside to far-end, and the iliac artery through being close to entry site arrives terminal aorta.For the blood vessel embolism in the iliac artery of entry site offside, can adopt the only active length of about 60cm.Yet if blood vessel embolism is arranged in femoral artery,superficial (SFA) or Wei Yu popliteal tremulous pulse, active length can reach about 140cm, maybe may be 160cm.The real work length range of passivity subdivision conduit 100 is about 60cm-140cm for offside is used, but is not limited thereto.Therefore, the total length of sleeve pipe 300 can be 50cm-130cm, but is not limited thereto.More than or all conduit sizes of providing of this paper other places all only be example, and can change according to the entry site of blood vessel, the position and the medical procedure of blood vessel embolism.
For entering cardiovascular system, what entry site can be when entering peripheral vascular system is identical, promptly by the femoral artery in the groin.The minimum active length of the passivity subdivision conduit 100 in embodiment is about 110cm.The upper limit is similar to the situation of peripheral-system or for about 140cm.The typical range of total length can be about 110cm-140cm, but is not limited thereto.Therefore, the total length of sleeve pipe 300 can be about 100cm-130cm, but is not limited thereto.
Passivity subdivision conduit 100 is shown as to have proximal handle 110, tack port 130, rotates haemostatic valve 140, strain-relief sections 150, proximal catheter shaft 160, distal catheter shaft 170 and work package 120.The driving conductive pipe work package 120 of handle mechanism 110 is passed on the opening and closing action.Particularly, reduce T-shape handle 110 distal portions and make driver part (not shown) in the catheter shaft 160/170 to the near-end axially-movable, the expandable element 122 of work package 120 is opened in this axially-movable.Reduce T-shape handle 110 proximal parts and make driver part (not shown) in the catheter shaft 160/170 to the far-end axially-movable, the expandable element 122 of work package 120 is closed in this axially-movable.But Handleset 110 can as Merlon or polyoxymethylene resin (Delrin), but be not limited thereto by the plastics manufacturing of general machining.
Tack port 130 provides the path of pump pickle to conduit 100 inside, thus aerofluxus before in inserting body.In the use, rotation haemostatic valve 140 is kept the fluid-tight path between catheter shaft 160/170 inside and the butt end mouth 130, makes catheter shaft 160/170 rotate according to doctor's needs simultaneously.
Sleeve pipe 300 comprises proximal joint 310, axle 320 and far-end 330.As previously mentioned, the total length of sleeve pipe 300 should make that when passivity subdivision conduit 100 enters sleeve pipe 300 fully the passivity subdivision conduit 100 of the 10cm that also has an appointment stretches out from the far-end of sleeve pipe 300, but is not limited thereto.
Fig. 2 a-2i illustrates substantially in the embodiment and comprises the clinical procedure of using conduit system.Fig. 2 a is that the blood vessel embolism proximal end of an embodiment medium vessels system comprises passivity subdivision conduit and telescopic conduit system.Passivity subdivision conduit 100 and sleeve pipe 300 advance simultaneously and arrive the complete thromboembolism 200 of blood vessel.The near-end of blood vessel embolism 200 is the true chambers 180 of blood vessel near-end, and the far-end of thromboembolism 200 is the true chamber 190 of far-end of blood vessel.The work package 120 of passivity subdivision conduit 100 advances until the offside that arrives blood vessel embolism 200.For the support for passivity subdivision conduit 100 is provided, the far-end 330 of sleeve pipe 300 remains on several approximately centimeters of far-end near passivity subdivision conduit 100.By the doctor passivity subdivision conduit 100 is applied axial force, so that passivity subdivision conduit work package 120 suitably engages with thromboembolism 200.
Fig. 2 b illustrates according to an embodiment, and passivity subdivision conduit advances and passes blood vessel embolism, and sleeve pipe remains near the blood vessel embolism place simultaneously.Fig. 2 c illustrates according to an embodiment, and passivity subdivision conduit is passing blood vessel embolism.Fig. 2 d illustrates according to an embodiment, and passivity subdivision conduit and sleeve pipe are passing blood vessel embolism.
When the next-door neighbour's blood vessel embolism 200 of conduit system position, user drives the expandable element 122 of passivity subdivision conduit 100 by handle mechanism 110, force the disorganization of contact expandable element 122, thereby in the thromboembolism of work package 120 far-ends, produce little partly cut-away (Fig. 2 b) at once.Expandable element 122 is closed subsequently, produce be suitable for that far-end enters the subdivision road prevent damage, bullet shaped far-end (Fig. 2 c).When the work package 120 of passivity subdivision conduit 100 passes blood vessel embolism 200 forward, repeat following steps: work package 120 is engaged with thromboembolism under the situation that expandable element 122 is closed,, then close expandable element 122 and enter the subdivision road to open position with rear drive expandable element 122.Under the situation suitable to program, sleeve pipe also passes blood vessel embolism 200 (Fig. 2 d) forward.
Fig. 2 e illustrates according to an embodiment, and passivity subdivision conduit leaves blood vessel embolism, and sleeve pipe is stayed in the blood vessel embolism.When the subdivision road in thromboembolism 200/pass thromboembolism 200 and form and passivity subdivision conduit 100 during to distal advancement, sleeve pipe 300 also can enter the subdivision road in the thromboembolism 200.
Fig. 2 f illustrates according to an embodiment, and passivity subdivision conduit and sleeve pipe all pass blood vessel embolism.The far-end 330 of sleeve pipe 300 advances on passivity subdivision conduit 100 and crosses complete thromboembolism 200.Like this, passivity subdivision conduit 100 can be all from vascular system rollback and taking out, stay sleeve pipe 300 and be positioned at the position of passing blood vessel embolism, far-end 330 is at the far-end of thromboembolism 200 simultaneously.Fig. 2 g illustrates according to an embodiment, and after taking out passivity subdivision conduit, sleeve pipe remains on the position of passing blood vessel embolism.
Fig. 2 h illustrates according to an embodiment, and leading line passes sleeve pipe and enters the true chamber of thromboembolism distal vessels.Leading line 400 can be any one in the multiple leading line type well known in the prior art, and its chamber that passes sleeve pipe 300 enters the true chamber 190 of blood vessel of thromboembolism 200 far-ends.Place after the leading line, sleeve pipe 300 is removed from vascular system, stay leading line 400 and be positioned at the position of passing thromboembolism 200.Then the medical apparatus and instruments used with delivery treatments of positioning and guiding line is to vascular site, as angiopoiesis air bag, speckle rotary cutting apparatus or stent.Fig. 2 i illustrates according to an embodiment, and after removing sleeve pipe, leading line is positioned at the position of passing blood vessel embolism.
In the discussion in front, passivity subdivision conduit and sleeve pipe are delivered to the blood vessel embolism position together, promptly in order to send/between delivery period passivity subdivision catheter cartridge to be loaded in the sleeve pipe.When in crown or peripheral blood vessel, using described system, use above-mentioned structure.Yet, for be applied to as through seen in some coronary artery anatomy of being everlasting to the vascular system with high tortuosity in, can wish to have the alternative approach at intravasation thromboembolism position.If the tortuosity of vascular system for passivity subdivision conduit and sleeve pipe as too extreme for the system motion, so ideal meeting is at first to come delivery cannula by the flexible more scheme of sending, and then sends passivity subdivision conduit to the blood vessel embolism position in sleeve pipe.The sleeve pipe conductor comprises very flexible polymer, thereby sleeve pipe/sleeve pipe conductor combination can provide flexible greatly at the assembly far-end, so that pass the blood vessel complications of higher degree, simultaneously boot proximal end is delivered to desirable vascular site.
In this alternative method, at first directly sleeve pipe is delivered to the blood vessel embolism position by the traditional direction line.Yet although the diameter of typical crown leading line is 0.014 inch, and telescopic nominal internal diameter is about 0.041 inch, because the boot proximal end leading edge exposes in a large number, causes the sleeve pipe cannot be directly and follow the trail of leading line safely.When advancing in vascular system, the leading edge of this exposure can cause cutting scraping blood vessel wall.In order to protect blood vessel wall not to be subjected to the damage of sleeve pipe leading edge, inside pipe casing supports by sleeve pipe conductor (being also referred to as occluder).
The sleeve pipe conductor is the single chamber cover plug along telescopic partial-length snug fit in sleeve pipe, and introduces guide wire lumen to hold standard blood vessel leading line.The distal portions of sleeve pipe conductor can stretch out about 0.5cm-3cm from boot proximal end, but is not limited thereto.The distal portions of sleeve pipe conductor comprises that at least one is beneficial to its tapered distal end of advancing and more atraumatic rounded distal.
In the first embodiment, the sleeve pipe conductor is designed to have the homogeneous external diameter on the whole length of proximal joint.This makes that the sleeve pipe conductor can remove from sleeve pipe easily when sleeve pipe is delivered to the blood vessel embolism position.
In alternate embodiment, the diameter of staying the sleeve pipe conductor cover plug in the sleeve pipe is first homogeneous diameter, and have only the sleeve pipe conductor distal portions that stretches out from boot proximal end can have second diameter that increases a little, make to form mild constant diameter from sleeve pipe conductor to telescopic conversion.In this structure, sleeve pipe conductor distal portions still can stop as described above.
In the embodiment, the near-end of sleeve pipe conductor ends at simple joint, and this simple joint comprises standard Lu Er (luer) adapter with the center cavity that is communicated with the guide wire lumen of single chamber cover plug.The proximal joint of sleeve pipe conductor also can be press fit into proximal end, is in suitable axle location to keep sleeve pipe and sleeve pipe conductor, promptly keeps the sleeve pipe conductor to stretch out boot proximal end 1cm-5cm in use.
Sleeve pipe is being introduced in the preparation of vascular system, the far-end of sleeve pipe conductor is loaded into telescopic proximal joint and advances, and is press fit in the casing joint until sleeve pipe conductor joint.In this structure, sleeve pipe conductor distal portions stretches out about 1cm-5cm from boot proximal end, and the combine component that is beneficial to be placed on the leading line is advanced, but is not limited thereto.In case be positioned at desirable vessel position place, sleeve pipe conductor and leading line can all be recalled, stay sleeve pipe at desirable vascular site.For the embodiment that sleeve pipe conductor distal portions diameter equals to overlap external diameter of pipe, sleeve pipe conductor end can make that when the sleeve pipe conductor removed, the end can be subjected to slight extruding in back off procedure by enough low polymer manufacturings of measuring hardness from sleeve pipe.
Durometer used herein is the measuring device of material hardness, but also comprises other suitable qualification known in the art.Therefore, the polymer durometer is the measuring device of polymer hardness.Therefore, durometer relates to the hardness measuring device of the device of being made by polymer.For example, and compare, use the hardness that relative higher degree is provided than the catheter shaft of the polymer lamination of high measurement hardness with the low catheter shaft of measuring the polymer lamination of hardness.In addition, compare, the flexibility of relative higher degree is provided with the low catheter shaft of measuring the polymer lamination of hardness with using catheter shaft than the polymer lamination of high measurement hardness.
Sleeve pipe conductor cover plug in embodiment is once extruded by one or more polymer and is made, described polymer comprises at least a in any multiple combination of polytetrafluoroethylene (PTFE), high density polyethylene (HDPE) (HDPE), low density polyethylene (LDPE) (LDPE) and these materials, but the sleeve pipe conductor is not limited to these polymer.One or more polymer lubricate in the embodiment.These polymer also can classification, so that the low polymer of measuring hardness to be provided at sleeve pipe conductor far-end, thereby provides the flexibility of higher degree.Making very flexible sleeve pipe conductor far-end is desirable feature, because easier like this tracking leading line, and makes in general that sleeve pipe conductor/cannula system is easier and advances.Scheme as an alternative, the sleeve pipe conductor can be made by braided material (rustless steel, polymer filaments) and similar polymerization thing lamination.
When making sleeve pipe conductor/sleeve pipe when target vascular site is advanced, sleeve pipe conductor far-end is exactly the front end of system.Therefore an embodiment middle sleeve conductor/sleeve pipe comprise in the sleeve pipe conductor distal portions/on fluorescent marker.The fluorescent labeling component is the thin-walled platinum band of the about 0.001-0.002 inch of thickness, the about 0.5mm-2mm of length for example, and this component can be embedded in the far-end polymer of sleeve pipe conductor, and perhaps scheme as an alternative uses medical adhesive to be fixed to the sleeve pipe conductor.Described band also can be by rustless steel manufacturing and coated with gold.Scheme as an alternative, described band can adopt stamping method to be embedded in the inner surface or outer surface of cover plug polymer.Scheme as an alternative can be printed on fluorescent ink the distal surface of sleeve pipe conductor, so that similar fluorescent labeling indication to be provided.When this fluoroscopic image arrives the information of blood vessel embolism near-end for the doctor provides indication sleeve pipe conductor/sleeve pipe.
An embodiment middle sleeve comprises axle system and near-end Lu Er joint, but is not limited thereto.This axle system comprise have the interpolymer layer, the assembly of intermediate layer, outer polymeric layer, far-end fluorescent labeling system and external lubrication coating, but be not limited thereto.Each of these assemblies is described as follows.
About the axle system in the embodiment, the interpolymer layer forms telescopic inner surface.For the ease of the passivity subdivision conduit in the sleeve pipe or other conduit advances and rollback, this internal layer comprises lubriation material, as polytetrafluoroethylene (PTFE), polyimides and the polyethylene that comprises high density polyethylene (HDPE) (HDPE), low density polyethylene (LDPE) (LDPE) and/or the two blend, but be not limited to these materials.These polymer are generally used for medical instruments field.This interpolymer layer can be chosen in to have identical materials and measures hardness on the whole casing length, or can selective polymer with the desired operating characteristic (flexible, torque adjustment) of customization along telescopic specific region.
The intermediate layer of the axle system in embodiment comprises the braiding filament, as stainless steel wire, Nitinol line, Kevlar or polyster fibre, but is not limited thereto.The braiding filament forms netted pipe, thinks that as the supporting construction assembly axle system provides hoop intensity.That the filament that is used for making this netted pipe comprises is flat, pros and circular structure at least a, and the combination of these filaments.In fact single quantity of planting filament can be about 8-32 filament, but be not necessarily limited to this.
Can use any filament material that required hoop intensity is provided, to keep the tubular structure of catheter shaft.The quantity of per inch filament (pic) is adjustable to the entire length that meets catheter shaft, perhaps changes the desired operating characteristic (flexible, torque adjustment) of pic to set conduit.Generally speaking, low pic number and low torque adjustment, higher flexibility are relevant with low hoop intensity.In addition, higher pic number is regulated with high torque, low flexibility is relevant with higher hoop intensity.In one embodiment, the pic number can be about 80-120pic/ inch.
The outer polymeric layer of axle system forms telescopic outer surface.This polymer is selected from the multiple polymer that is usually used in medical instruments field, comprise at least a in nylon, polyurethane, polyethylene, polyimides, block polyetheramides (Pebax), polyamide (Grilamid) and the Merlon ammonia ester (carbothane), but outer polymeric layer is not limited thereto.Select the desired operating characteristic (flexible, torque adjustment) of material to set conduit of outer polymeric layer.Select outer layer copolymer to make and on telescopic whole length, have identical materials and measure hardness, perhaps can select outer layer copolymer to provide different operating characteristics with zones of different or part for catheter shaft.
Particularly, with respect to the proximal part of catheter shaft, the distal portions of catheter shaft generally can need flexible largely, advances so that pass vascular bending (especially coronary vasodilator).Scheme as an alternative, the proximal part of catheter shaft can need bigger thrust and torque adjustment feature, is beneficial to the further distal advancement in vascular system of conduit.In order to realize these operating characteristics, be the near-end of conduit and the polymer of distal portions selection different measuring hardness.For example, low one or more distal portions of measuring the polymer formation catheter shaft of hardness are beneficial to flexibility, are beneficial to promote and torque adjustment than one or more proximal parts of the polymer formation catheter shaft of high measurement hardness.Be used for more specifically supporting partly that at catheter proximal end another polymer that promotes with torque adjustment is a polyimides that this polymer generally can not the molding once more by heating as aforesaid thermoforming polymer.
Make as mentioned above and comprise during the sleeve pipe main shaft of internal layer polymer, tubular braid and outer layer copolymer lamination body the mutual physical connection of inner surface or the combination of the outer surface of internal layer polymer lining and outer layer copolymer lamination body.This connection occurs on the cross point of the litzendraht wire that forms braided tubular member.These two surfaces produce the unified structure of quill by the physical engagement of braided tubular member.Yet problem is to be used for the material of the interior lining of an embodiment, and promptly polytetrafluoroethylene (PTFE), high density polyethylene (HDPE) (HDPE) or low density polyethylene (LDPE) (LDPE) all are very difficult to combine with other polymer.
In the first embodiment, when using PTFE,, form outer layer copolymer lamination body on the outer surface and can be incorporated into wherein microscopic voids, and overcome this problem by outer surface with the acid etching PTFE tube as liner.If Pebax or nylon are used for outer layered product, then processing temperature can be about 400 degrees Fahrenheits (F)~450 degrees Fahrenheit, and this temperature is enough to make these polymer flow, but deficiency is so that the space on teflon lined and the liner outer surface is mobile.When being laminated to outer layer copolymer on the quill, outer layer copolymer lamination body flows through or is flowing between the cross point of litzendraht wire, and flows on the outer surface of inner PTFE lining.Regulate the thickness of outer layer copolymer lamination body, make litzendraht wire be included in fully in the outer layered product, and outer layer copolymer lamination body forms level and smooth continuous surface.In the cooling procedure of layered product, the inner surface of outer layer copolymer " lock " is gone in the space of internal layer polymer lining, thereby connects these two kinds of polymer between litzendraht wire.
In the alternate embodiment that the internal layer polymer lining is made of high density or low density polyethylene (LDPE), quill can with any same material lamination.Because these materials have identical melt temperature, internal layer polymer lining and outer layer copolymer lamination body will be easy to be bonded with each other, and make unified reel structure.
Axle system in embodiment comprises far-end fluorescent labeling system, indication distal end of catheter when observing under cryptoscope.One class Mk system comprises that (wall thickness is generally about 0.001-0.002 inch to the platinum loop that embeds in the distal end of catheter polymer; Length is generally about 0.5mm-2mm).Scheme as an alternative, this ring also can be made and coated with gold by rustless steel.This ring is placed on the interior or outside of woven tubular net, and with internal layer polymer or outer layer copolymer lamination.
The Mk system of scheme uses the platinum coil as an alternative.This platinum coil is placed in the mode similar to above-mentioned platinum band, but is not limited thereto.
Another is the adhesive or the chemical compound of the Mk system use radip-opaque of scheme as an alternative, is printed onto on the surface of internal layer polymer, woven tubular net or outer layer copolymer.These adhesive use tantalum, bismuth, gold, silver or platinum usually, but are not limited to these.
The Mk system of another scheme as an alternative comprises gold plating.Gold plating is positioned on the tubular reticulum distal portions, but can be positioned at different positions in alternate embodiment.
Again one as an alternative the Mk system of scheme be included in and use fluorescent material (for example bismuth) in the axle system material.In one embodiment, in the structural polymer with fluorescent material implanted layer gland pipe far-end.
About the external lubrication coating of above-mentioned axle system, the outer layer copolymer surface can apply lubriation material, as silicone dispersant or the hydrophilic coating of scheme (Surmodics) as an alternative.Although the lesion vessels inner surface can contain fibrosis material, calcium, and/or vessel diameter can obviously reduce, this coating is used for further being convenient to delivery catheter and passing vascular system by reducing friction between catheter outer surface and the vascular inner surface.
The near-end female joint of cannula system comprises the Lu Er adapter of standard.The support of Lu Er adapter is connected to the intervention device of other standard; For example syringe is connected to this joint with irrigating catheter before use.Proximal joint is by the multiple polymer manufacturing that is usually used in medical apparatus and instruments, for example Merlon.
Sleeve pipe in embodiment has the external diameter of about 0.050-0.070 inch, but is not limited thereto.The name external diameter is about 0.0560 inch.
Sleeve pipe in embodiment has the internal diameter of about 0.035-0.050 inch, but is not limited thereto.The name internal diameter is about 0.040 inch.
Sleeve pipe in embodiment has the active length of about 80cm-150cm, but is not limited thereto.The name active length is about 130cm.
Conduit manufacture process in embodiment is included in the woven tubular net (intermediate layer) mobile interior and/or outer in the space.Like this, internal layer polymer merges mutually with outer layer copolymer, forms the bridge of crossing over netted pipe.This obtains whole axle layered product, and it provides intensity, torque adjustment and the reliability of increase for axle construction.
As mentioned above, the polymer that forms the catheter shaft in the embodiment comprises the polymer of different measuring hardness, and it allows to regulate the specific operational characteristics of catheter shaft different piece.In addition, the polymer grade from catheter proximal end to far-end can descend gradually.For example, proximal end region of catheter shaft (the most approaching about 80cm) and Grilamid lamination then are 73D Pebax zone (the about 8cm of length), then are 63D Pebax zone (the about 8cm of length), then are 55D Pebax zone (the about 5cm of length).In this way, the transformation from a kind of polymer to following a kind of polymer is gradual change, and the flexibility of catheter shaft increases gradually.
Fig. 3 a is the conduit system according to an embodiment, comprises sleeve pipe 300 and sleeve pipe conductor 350.Sleeve pipe 300 and sleeve pipe conductor 350 are shown as a system, but are not limited thereto.In this structure, the traditional direction line of the traceable center cavity 365 by sleeve pipe conductor 350 of this system is delivered to position near blood vessel embolism with boot proximal end.In order to see assembly clearly, sleeve pipe conductor 350 is shown as to the near-end rollback with joint 360.Yet between the operating period, sleeve pipe conductor joint 360 can be press fit into casing joint 310, and sleeve pipe 300 and sleeve pipe conductor 350 are linked together.In this structure, the distal portions 380 of sleeve pipe conductor 350 stretches out about 0.5cm-5cm from boot proximal end 330, but is not limited thereto.After the traditional direction line marches to target vascular site, remove leading line and sleeve pipe conductor 350, make boot proximal end 330 be positioned at position near blood vessel embolism, it is that another conduit such as passivity subdivision conduit 100 can be delivered to blood vessel embolism by this pipeline as pipeline that boot proximal end 330 is positioned at herein.
Though sleeve pipe 300 is described to and 100 collaborative works of passivity subdivision conduit, in case when being positioned at vascular site, that sleeve pipe 300 can be used for sending is known in the art, size and sleeve pipe 300 are compatible other type conduit system or apparatus.For example, can at first send the traditional direction line, if desired, attempt before using passivity subdivision conduit 100, at first passing thromboembolism.If leading line can not successfully pass thromboembolism, then removable leading line can advance passivity subdivision conduit 100 in sleeve pipe 300, be used for passing thromboembolism.
Fig. 3 b is the longitdinal cross-section diagram according to sleeve pipe 300 distal portions of an embodiment.The axle of sleeve pipe 300 comprises the internal layer polymer lining 303 that is woven with wire rod 302 on it.This axle and another polymer (304-309) lamination subsequently.Because the Action Target of sleeve pipe 300 provides very flexible distal end portion, so outer layer copolymer lamination body can be from proximal part measures the gradual change of hardness polymer than high measurement hardness polymer to distal portions low.For example, described axle comprises 6 independent outer layered products in the 304-309 part.The outer layered product of 304 parts uses Pebax63D to make, the outer layered product of 308 parts is then made by the low hardness polymer P ebax 55D that measures, the outer layered product of 307 parts then is Pebax 40D, or the like, reduce the hardness of outer layered product polymer gradually, until the distal portions 330 that arrives sleeve pipe 300.Though in the present embodiment, described 6 grades of polymer, can use still less or the polymer of greater number comes to provide appropriate physical characteristic as axle.
Another material that is used for the catheter shaft of alternate embodiment comprises polyethylene, carries out suitable classification at this polyethylene according to the purpose purposes of conduit system.In another embodiment, can change polymer type to obtain suitable flexibility.
The internal layer polymer layer 303 of an embodiment comprises the height lubriation material, and this is because the inner chamber of sleeve pipe 300 is used for back and forth sending other device.Liner 303 for example can be made by polytetrafluoroethylene (PTFE) or high density polyethylene (HDPE) (HDPE), but is not limited thereto.The hardness of liner 303 can be carried out classification as mentioned above, so that suitable soft degree to be provided.For example, low density polyethylene (LDPE) (LDPE) can be used for the distal-most end 330 of sleeve pipe 300, so that the soft degree that is higher than HDPE to be provided.
Torque adjustment, flexibility, hoop intensity and the wall thickness that is fit to concrete application depended in the selection of braided material.For example, litzendraht wire can be the flat stainless steel wire of 0.001-0.003 inch as an example.Litzendraht wire also can be 0.002 inch a round line.The circle litzendraht wire provides overall flexibility, hoop intensity and the torque adjustment of higher degree to the quill structure.Yet the circle litzendraht wire generally obtains than the bigger catheter shaft of the overall wall thickness of flat wire system.Also can use the braided material of scheme as an alternative, as polyster fibre or other suitable polymers; These as an alternative the material of scheme the torque adjustment or the hoop intensity of same degree generally are not provided, but can improve the overall flex of quill.
Sleeve pipe 300 distal portions 330 layered products that comprise atraumatic end 310 and fluorescent labeling band 311 are as follows.Fluorescent labeling band 311 is fixed in quill in many ways.In one embodiment, indicia band 311 is in the outside of wire rod knitted body 302, and lamination outer layer copolymer lamination body 309 from the teeth outwards.Thereby indicia band 311 is encapsulated in outer layer copolymer lamination body inside, and it provides smooth surface for boot proximal end part 330.Continue this embodiment is discussed, the far-end of the far-end of wire rod knitted body 302 and indicia band 311 also can stop mutually simultaneously.In addition, internal layer polymer lining 303 can stretch out about 1mm-10mm from the end of indicia band 311 and litzendraht wire 302, but is not limited thereto.In order to finish manufacturing, outer layer copolymer 309 continues to cover indicia band 311 forming atraumatic polymer end 310 at far-end, and the far-end of itself and liner 303 stops simultaneously.Thereby the length of atraumatic end 310 equals the length that internal layer polymer lining 303 and outer layer copolymer lamination body 309 stretch out indicia band 311.
The shape of atraumatic end 310 presses the distal annular rim edge of body to realize by sphering or the outside the pale of civilization one polymer layer of taper.This process is commonly referred to the end molding, and can place the heated glass mould to come preforming by the assembly that will make, and the in-profile of described mould has fashioned into required end shape.When placing described mould, heat outer layered product so that outer layered product begins to soften and obtain the interior shape of described mould.During mold cools down, end of conduit 310 is retained in the mould, with atraumatic taper or round-shapedly be solidified as the far away by 310 of sleeve pipe 300.When finishing cooling, from mould, remove end of conduit 310.The method of heating mould can be by traditional Convective Heating on the spot, and perhaps scheme also can use radiation frequency can come to heat on the spot atraumatic end 310 as an alternative.
It is long that the size of indicia band generally can be about 0.05mm-3mm, and the 0.001-0.003 inch is thick, but is not limited thereto.Indicia band can be made of a variety of materials.It is a kind of that the material of suitable fluoroscopic image is provided is platinum, or such as the alloy of platinum-iridium or platinum-tungsten.Scheme as an alternative, indicia band is made and coated with gold by rustless steel.In described size, rustless steel itself does not provide suitable fluoroscopic image, therefore applies material such as the gold that has more fluorescence, so that suitable fluoroscopic image to be provided.The gold plating of about 0.0005-0.002 inch provides enough fluoroscopic images usually.
Fig. 3 c is the longitdinal cross-section diagram according to sleeve pipe 300 far-ends of an alternate embodiment.This embodiment comprises two indicia band, internal labeling band 312 and external labeling band 311.Internal labeling band 312 is below litzendraht wire 302 and be close to the proximal part of internal layer polymer lining 303 and the distal portions of polymer inner liner 304.Second indicia band 311 is in the outside of litzendraht wire 302.Like this, litzendraht wire 302 is clipped in the middle of described two indicia band, and should the zone can further weld, bonding or welding, be connected with the firm of litzendraht wire 302 so that indicia band 311/312 to be provided.As mentioned above, litzendraht wire and indicia band can have common far-end terminating point.Equally, the near-end of indicia band 311/312 also can have common near-end terminating point.Scheme as an alternative, the far-end of arbitrary indicia band and/or near-end can be positioned at the near-end or the far-end of another indicia band respective proximal and/or far-end.Further specify this alternate embodiment, internal layer polymer lining 304 and outer layer copolymer lining 310 also can extend beyond the far-end of arbitrary indicia band, so that above-mentioned atraumatic end to be provided.
Fig. 3 d is the longitdinal cross-section diagram according to sleeve pipe 300 far-ends of another embodiment.The far-end of internal layer polymer lining 303 and arbitrary indicia band stops simultaneously, and outer layer copolymer lamination body 309 stretches out from indicia band at far-end, to form atraumatic end 310.This embodiment also can only be made with an indicia band 311, and this indicia band 311 is positioned at the outside of litzendraht wire 302 as mentioned above.
Fig. 3 e is the longitdinal cross-section diagram according to sleeve pipe 300 far-ends of another embodiment.This far-end comprises aforesaid internal labeling band 312 and external labeling band 311.Yet internal labeling band 312 surpasses the far-end of external labeling band at remote extension.This extends to the preformed metal of connection or the polymer nose cone provides annular to connect platform.The metal nose cone can weld or be bonded to internal labeling band 312, perhaps scheme as an alternative, and the polymer nose cone also can be bonded to the extension of internal labeling band 312.Liner 303 can stop simultaneously to remote extension and described nose cone.
Fig. 3 f is the longitdinal cross-section diagram according to the proximal joint of the sleeve pipe 300 of an embodiment.At least a the making that proximal joint 310 adopts in Merlon, nylon and other injection moldable polymer, but be not limited thereto.Proximal joint 310 can by bonding, embed a kind of proximal end axle 320 that is connected in molding and the thermal bonding.Proximal joint 310 has near-end Lu Er adapter, is used for being connected to other device as syringe (for example, being used for using before use the normal saline washing conduit).Near-end Lu Er comprises tapered introducing district 318, makes the proximal openings of Lu Er enter in the telescopic near-end chamber 375.Introducing district 318 allows easily with in sleeve pipe conductor 350 or passivity subdivision conduit 100 lead-in bushings 300.
Above-mentioned sleeve pipe 300 comprises unified internal diameter, and itself and passivity subdivision conduit 100 have high tolerance fit.The sleeve pipe of alternate embodiment comprises the distal portions of quill, and the external diameter of itself and passivity subdivision conduit 100 has high tolerance fit, and at the near-end of described part, telescopic internal diameter can increase slightly.This is configured in bigger annular space is provided between passivity subdivision conduit and the sleeve pipe, to improve the overall movement of passivity subdivision conduit in sleeve pipe.
The length that has the described distal portions of high tolerance fit with passivity subdivision conduit 100 external diameters has wide region, and its lower limit only comprises sleeve pipe 300 distal-most end 1cm, and the upper limit then reaches the whole length of sleeve pipe 300.The actual range that has the boot proximal end part of high tolerance fit with passivity subdivision conduit is about 5cm-20cm.The increase of diameter can be about 0.002-0015 inch, but is not limited thereto.As practical embodiment, the internal diameter of boot proximal end part has about 0.042 inch nominal diameter, and the internal diameter that closes on this distal portions can increase to 0.045 or 0.047 inch.A small amount of increase of this annular space can obviously improve motion.Yet, in described two embodiments, all wish between boot proximal end part and passivity subdivision conduit, to keep high closely tolerance fit, provide alap profile (profile) with far-end in whole system.
Fig. 4 a is the longitdinal cross-section diagram according to the proximal end joint of an embodiment.Fig. 4 b is having the fluorescent labeling band and having the longitdinal cross-section diagram of the sleeve pipe conductor distal portions of taper configurations according to an embodiment.Fig. 4 c is having the fluorescent labeling band and having the longitdinal cross-section diagram of the sleeve pipe conductor distal portions of circular structure according to an embodiment.
With reference to Fig. 4 a, 4b and 4c, the sleeve pipe conductor comprises joint 360, axle 370 and fluorescent labeling band 385.Sleeve pipe conductor 350 is configured to insert the inside of sleeve pipe 300, make when inserting fully, the distal portions of sleeve pipe conductor axle 370 stretches out the about 0.5cm-5cm of sleeve pipe 300 far-ends, but is not limited thereto, and sleeve pipe conductor proximal joint 360 is force-fitted in the proximal end joint 310.Sleeve pipe conductor axle 370 external diameters are configured to provide and the closely cooperating of sleeve pipe 300 internal diameters, as above-mentioned cooperation between passivity subdivision conduit 100 and sleeve pipe 300.
As assembly, sleeve pipe conductor/sleeve pipe can be followed the trail of leading line to suitable vascular site by sleeve pipe conductor centre pilot line chamber 365.As previously mentioned, sleeve pipe 300 generally cannot be followed the trail of leading line, because the internal diameter of sleeve pipe 300 has about 0.042 inch nominal diameter, and conventional tube tremulous pulse leading line has about 0.014 inch diameter.Therefore, there is big annular gap, causes telescopic leading edge to come out and withstand blood vessel wall.The sleeve pipe conductor provides physical interface between leading line and sleeve pipe 300, fill the annular gap between described two conduits.
Sleeve pipe conductor axle 370 in embodiment comprises the lubriation material that improvement is advanced with leading line, and when system has entered suitable vascular site, is convenient to sleeve pipe conductor 350 rollback from sleeve pipe 300.The proper lubrication material comprises polytetrafluoroethylene (PTFE), high density polyethylene (HDPE) (HDPE) or low density polyethylene (LDPE) (LDPE).The typical sizes of sleeve pipe conductor comprises the internal diameter of about 0.016-0.022 inch and the external diameter of about 0.039-0.043 inch, but embodiment is not limited to this size.When sleeve pipe conductor 350 was inserted in the sleeve pipe 300 fully, as mentioned above, predetermined sleeve pipe conductor distal portions 370 extended beyond the far-end of sleeve pipe 300.This length allows to seamlessly transit to sleeve pipe 300 and be beneficial to the tracking leading line from sleeve pipe conductor 350.
With reference to Fig. 4 a, described proximal joint 360 is shown is connected to sleeve pipe guidance axis 370.Described proximal joint 360 adopts at least a formation in Merlon, nylon and other the suitable injection molding polymer.Described proximal joint 360 comprises near-end Lu Er adapter 362, is used to be connected to conventional apparatus, as using the syringe in normal saline washing chamber 365 before use.Described proximal joint 360 also comprises leading line leading-in end 367, and it provides seamlessly transitting of near-end chamber from the proximal openings of joint 360 to axle 370, and allows leading line to enter easily in the sleeve pipe conductor 350.Leading line leading-in end 367 also can adopt at least a formation in Merlon, nylon and other the suitable injection molding polymer.Utilize bonding, as to insert molding and thermal bonding a kind of combination to be connected proximal joint 360, leading line leading-in end 367 and axle 370.Scheme as an alternative, leading line leading-in end 367 and proximal joint form the single piece type assembly.
With reference to Fig. 4 b and 4c, the far-end of sleeve pipe conductor axle 370 comprises fluorescent labeling band 385.Described indicia band embeds or is connected to the wall of sleeve pipe conductor axle 370 by several embodiments.In the first embodiment, shown in Fig. 4 b and 4c, indicia band 385 is molded to the body of sleeve pipe conductor axle 370, makes the outer surface of indicia band 385 flush with the outer surface of sleeve pipe conductor axle 370.This fixes on the abundant physical locks of indicia band in the sleeve pipe conductor axle 370, satisfies the minimum overall thickness of sleeve pipe conductor axle 370.The nominal polymer thickness that covers indicia band is about 0.002-0.004 inch, but is not limited thereto.
In second embodiment, the inner surface of the inner surface of indicia band 385 and sleeve pipe conductor axle 370 flushes.This embodiment adopts the sleeve pipe conductor axle 370 of equal thickness.In the 3rd embodiment, indicia band 385 is included in sleeve pipe conductor axle 370 bodies fully, and the thin layer polymer covers on the inside and outside both side surface of indicia band 385.The thickness of described layer is about 0.001-0.003 inch, but is not limited thereto.
Sleeve pipe conductor far-end can terminate as taper or circle.End shape can be similar to the method for distal end of described processing sleeve pipe 300 like that by hot briquetting.These shapes provide seamlessly transitting from leading line to sleeve pipe conductor far-end, and help sleeve pipe conductor far-end to follow the trail of leading line, especially in very serious lesion vessels.
Above-mentioned passivity subdivision conduit can be any a plurality of conduit and/or work package.For example, the visible U.S. Patent No. 5,968,064,6 of the detailed description of representational passivity subdivision conduit, 508,825,6,599,304 and 6,638,247, and U.S. Patent Application Publication No.US-2004-0077999-A1 and U.S. Patent application No.09/835,043.Fig. 5 a is according to an embodiment, has the work package 500 of the passivity subdivision conduit of two expandable elements 506/508 of opening structure.Work package 500 is another embodiment of above-mentioned work package 120 shown in Fig. 1 and the series of drawing 2a-2i, and embodiment is not limited to this.Fig. 5 b is according to an embodiment, has the work package 500 of the passivity subdivision conduit of two expandable elements 506/508 of closing structure.Fig. 5 b is according to an embodiment, the exploded view of the work package 500 of passivity subdivision conduit.
With reference to Fig. 5 c, work package 500 comprises base part 502, driver part 504, first expandable element 506 and second expandable element 508.Hinge pin 510 is connected to driver part 504 and base assembly 502 with the one 506 and the 2 508 expandable element.During expandable element 506/508 launched as mentioned above, each rotated around the near-end of far-end around expandable element 506/508 in hinge pin 510 supports the one 506 and the 2 508 expandable element.Rod pin 512 is connected to driver part 504 each of expandable element 506/508.As a result, the linear driving force 514 that allows will to be applied on the driver part 504 of the connection between driver part 504, hinge pin 510, rod pin 512 and the expandable element 506/508 converts the radial motion of each expandable element around each hinge pin 510 to.
In aforesaid operations, work package 500 contacts with blood vessel embolism and/or blood vessel wall or approximate contact, is beneficial to destroy blood vessel embolism.The linear driving force 514 that applies is applied to driver part 504 on the proximal direction with being included in, (for example convert expansion or mechanical force and motion to, about outside radial force and the motion of expandable element 506/508 with respect to each hinge pin 510), and be applied on the blood vessel wall by expandable element 506/508 subsequently.Be applied to expansion or mechanical force on blood vessel embolism and/or the blood vessel wall and tear, break or otherwise destroy blood vessel embolism, and the blood vessel wall around not injuring.As mentioned above, the lasting linearity of blood vessel embolism is destroyed passage or the runner that generation has sufficient size, be used to make work package 500 and conduit system to pass thromboembolism.Leading line known in the art or other conduit are advanced in the thromboembolism that cuts, carry out optionally medical procedure.
The above-mentioned system and method based on interposing catheter that is used to produce the initial channel of passing blood vessel embolism comprises conduit system, described conduit system comprises: catheter shaft and at least one are arranged in the chamber of catheter shaft, described catheter shaft comprises the woven tubular assembly, wherein at least one internal layer polymer lining is connected to described woven tubular module inner, at least one outer layer copolymer lamination body is connected to described woven tubular module outer surface, and the polymeric material of outer layer copolymer lamination body intersperses among among the described woven tubular assembly and connects (being called lamination and/or bonding alternatively) to the outer surface space of internal layer polymer lining.
An embodiment ectomesoderm polymer multilayer structure comprises multiple polymers, and wherein each forms the one or more parts along catheter shaft length.
Measurement hardness number along the each several part of catheter shaft length direction in embodiment vertically reduces towards the distal direction of catheter shaft.
Outer layer copolymer lamination body in embodiment also comprises multiple polymers.One or more described polymer can have different measurement hardness numbers, and each of wherein said multiple polymers forms one or more zone of dispersions of outer layer copolymer lamination body.Has zone of dispersion than the polymer formation outer layer copolymer lamination body far-end of low durometer, zone of dispersion with polymer formation outer layer copolymer lamination body near-end of higher hardness value, wherein the remote area of catheter shaft has than the relative higher flexibility of catheter shaft proximal end region.Multiple polymers comprises 6 kinds of polymer in the embodiment.
The far-end end points of the conduit axocoel in embodiment forms the annular opening that is positioned at the catheter shaft far-end.Annular opening comprises the polymer that forms atraumatic end, but is not limited thereto.Atraumatic end can be the single polymers with tapered distal region.Atraumatic end can be the single polymers with rounded distal zone.Atraumatic end can be made up of internal layer polymer and outer layer copolymer.
Catheter shaft in embodiment comprises the fluorescent labeling system.Described fluorescent labeling system comprises first marked region that is positioned at woven tubular assembly outside.Fluorescent labeling system in embodiment comprises second marked region that is positioned at the woven tubular component internal.
Conduit system in embodiment also comprises the sleeve pipe conductor, described sleeve pipe conductor comprises having the assembly that near-end and far-end and formation are configured to follow the trail of the single cavity of leading line, wherein said assembly is configured to insert in the catheter shaft, when described assembly inserted fully, the remote area of described assembly stretched out from the far-end of catheter shaft.Sleeve pipe conductor in embodiment also comprises at least one joint that is positioned at near-end, and described joint construction is for to lock in the proximal joint of described catheter shaft when the sleeve pipe conductor inserts in the catheter shaft fully.The sleeve pipe conductor also can comprise the fluorescent labeling system that is positioned at described assembly remote area.
The above-mentioned system and method based on interposing catheter that is used to produce the initial channel of passing blood vessel embolism comprises conduit system, described conduit system comprises: catheter shaft and conductor, described catheter shaft comprises the woven tubular assembly, wherein at least one internal layer polymer lining is connected to described woven tubular module inner, at least one outer layer copolymer lamination body is connected to described woven tubular module outer surface, the polymeric material of outer layer copolymer lamination body intersperses among among the described woven tubular assembly and connects (lamination, bonding) to the outer surface space of internal layer polymer lining, wherein the internal layer polymer lining forms the chamber in the catheter shaft; Described conductor comprises and has near-end and far-end and form the assembly that structure is followed the trail of the single chamber of leading line, and wherein said assembly is configured to insert in the catheter shaft, and when described assembly inserted fully, the remote area of described assembly stretched out from the far-end of catheter shaft.
Conductor in embodiment also comprises at least one joint that is positioned at near-end, and described joint construction is for to lock in the proximal joint of described catheter shaft when the sleeve pipe conductor inserts in the catheter shaft fully.
At least one catheter shaft and conductor in embodiment comprise the fluorescent labeling system that is positioned at described assembly remote area.
Outer layer copolymer lamination body in embodiment comprises multiple polymers.One or more described polymer can have different measurement hardness numbers, and each of wherein said multiple polymers forms one or more zone of dispersions of outer layer copolymer lamination body.Has the low zone of dispersion of measuring the polymer formation outer layer copolymer lamination body far-end of hardness number, have the zone of dispersion than the polymer formation outer layer copolymer lamination body near-end of high measurement hardness number, wherein the remote area of catheter shaft has than the relative higher flexibility of catheter shaft proximal end region.
The above-mentioned system and method based on interposing catheter that is used to produce the initial channel of passing blood vessel embolism comprises conduit system, described conduit system comprises: sleeve pipe, described sleeve pipe comprises catheter shaft, and described catheter shaft has at least one chamber and the end forms the annular opening that is positioned at the catheter shaft far-end; With the intravascular tissue dilating catheter, it comprises conduit, housing and driver part, wherein said conduit comprises the far-end and the longitudinal axis, at least one pipeline extends along the described longitudinal axis, wherein said housing is formed on the catheter shaft far-end, comprise by pivotally connected at least one yoke assembly that near-end limited and free distal end end to catheter shaft, the arc that described end is passed away from the longitudinal axis of described axle comes the blood vessel dilating tissue, and wherein said driver part disposes so that the distal end of at least one yoke assembly leaves the longitudinal axis of described catheter shaft along catheter shaft.
Yoke assembly comprises one or more hinges (hinge) in the embodiment.
Driver part in embodiment comprises the push mechanism that is connected at least one yoke assembly.Yoke assembly in embodiment uses at least one hinge pin to be connected to housing, supports at least one hinge that at least one yoke assembly rotates to form when the push mechanism edge when the direction of near-end is pushed.
The measurement hardness number that forms the material of trocar guide tube axle vertically reduces towards distal direction, but is not limited thereto.
Trocar guide tube axle in embodiment also comprises the woven tubular assembly, wherein at least one internal layer polymer lining is connected to described woven tubular module inner, at least one outer layer copolymer lamination body is connected to described woven tubular module outer surface, and the polymeric material of outer layer copolymer lamination body intersperses among among the described woven tubular assembly and connects (lamination, bonding) to the outer surface space of internal layer polymer lining.Outer layer copolymer lamination body in embodiment comprises multiple polymers.One or more described polymer can have different measurement hardness numbers, and each of wherein said multiple polymers forms one or more zone of dispersions of outer layer copolymer lamination body.Has the low zone of dispersion of measuring the polymer formation outer layer copolymer lamination body far-end of hardness number, have the zone of dispersion than the polymer formation outer layer copolymer lamination body near-end of high measurement hardness number, wherein the remote area of catheter shaft has than the relative higher flexibility of catheter shaft proximal end region.
Annular opening comprises the polymer that forms atraumatic end in the embodiment.Atraumatic end can be the single polymers with tapered distal region.Atraumatic end can have the single polymers in rounded distal zone.Atraumatic end can be made of internal layer polymer and outer layer copolymer.
An embodiment middle sleeve catheter shaft comprises the fluorescent labeling system.Described fluorescent labeling system comprises first marked region that is arranged in woven tubular assembly outside and is positioned at second marked region at least a of woven tubular component internal.
Conduit system also comprises the sleeve pipe conductor in the embodiment, described sleeve pipe conductor comprises having the assembly that near-end and far-end and formation are configured to follow the trail of the single chamber of leading line, wherein said assembly is configured to insert in the trocar guide tube axle, when described assembly inserted fully, the remote area of described assembly stretched out from the far-end of catheter shaft.An embodiment middle sleeve conductor also comprises at least one joint that is positioned at near-end, and described joint construction is for to lock in the proximal joint of described trocar guide tube axle when the sleeve pipe conductor inserts in the catheter shaft fully.Sleeve pipe conductor in embodiment also comprises the fluorescent labeling system that is positioned at described assembly remote area.
The above-mentioned system and method based on interposing catheter that is used to produce the initial channel of passing blood vessel embolism comprises the method for passing thromboembolism, may further comprise the steps: by assembling conduit system in the sleeve pipe that passivity subdivision conduit is packed into; Make conduit system advance to vascular site and at least one extension element of passivity subdivision conduit is positioned near the thromboembolism; Make the extension element far-end around the extension element proximal deflection by the response expansion force, thereby make the far-end transverse movement of at least one extension element and leave the longitudinal centre line of passivity subdivision conduit, vascular tissue and thromboembolism are applied bursting force; Respond the bursting force that is applied and destroy the obstructive material and also form the path that passes destroyed material; And utilize formed path that at least one passivity subdivision conduit and sleeve pipe are advanced and pass the obstructive material, make at least one passivity subdivision conduit and sleeve pipe pass the obstructive material, and make the obstructive material be retained in this conduit system outside.
Method in embodiment also is included in and removes from blood vessel before the passivity subdivision conduit, sleeve pipe is advanced pass thromboembolism.
Method in embodiment also is included in and removes after the passivity subdivision conduit, removes before the sleeve pipe, utilizes sleeve pipe that leading line is advanced and passes (displaced) thromboembolism of having cut open.
Method in embodiment also comprises to be selected leading line and makes it pass endovascular blood vessel embolism.
Method in embodiment also is included in and removes before the passivity subdivision conduit and leading line is passed before the sleeve pipe, sleeve pipe is advanced pass thromboembolism.
Method in embodiment also is included in and sleeve pipe is advanced pass after the thromboembolism, utilize sleeve pipe that leading line is advanced and pass thromboembolism.
The above-mentioned system and method based on interposing catheter that is used to produce the initial channel of passing blood vessel embolism also comprises the method for passing thromboembolism, may further comprise the steps: make endovascular first leading line of vascular system advance to thromboembolism; By assembling cannula system in the sleeve pipe that the sleeve pipe conductor is packed into; Make cannula system follow first leading line and advance, make the far-end of cannula system near thromboembolism; From vascular system, remove first leading line and sleeve pipe conductor; Passivity subdivision conduit is advanced pass sleeve pipe to be positioned near the thromboembolism with at least one extension element with passivity subdivision conduit; Make the extension element far-end around the extension element proximal deflection by the response expansion force, thereby make the far-end transverse movement of extension element and leave the longitudinal centre line of passivity subdivision conduit, vascular tissue and thromboembolism are applied bursting force; Respond the bursting force that is applied and destroy the obstructive material and also form the path that passes destroyed material; And utilize formed path that at least one passivity subdivision conduit and sleeve pipe are advanced and pass the obstructive material, make at least one passivity subdivision conduit and sleeve pipe pass the obstructive material, and make the obstructive material be retained in this conduit system outside.
Method in embodiment also is included in and removes from blood vessel before the passivity subdivision conduit, sleeve pipe is advanced pass thromboembolism.
Method in embodiment also is included in and removes after the passivity subdivision conduit, removes before the sleeve pipe, utilizes sleeve pipe that second leading line is advanced and passes the thromboembolism of having cut open.
Method in embodiment also comprises to be selected second leading line and it is advanced to pass endovascular blood vessel embolism.
Method in embodiment also is included in and removes before the passivity subdivision conduit and second leading line is passed before the sleeve pipe, sleeve pipe is advanced pass thromboembolism.
Method in embodiment also is included in and sleeve pipe is advanced pass after the thromboembolism, utilize sleeve pipe that second leading line is advanced and pass thromboembolism.
Unless context clearly needs, otherwise the wording in description and the claim " comprises ", " comprising " etc. be defined as the containing implication opposite with exclusive or exhaustive implication; That is, be the implication of " including, but are not limited to this ".The wording of use DANFU number also comprises the quantity of plural number or odd number respectively.In addition, term " this paper ", " hereinafter ", " above-mentioned ", " following " and similar terms are used for when of the present invention, refer to integral body rather than the application's of the application specific part.When wording " or " when being used to quote two or more project of enumerating, this wording comprises following all explanations: any project in enumerating, in enumerating all items and enumerate in the combination in any of project.
The above-mentioned illustrative purposes of the exemplary of conduit system is not exhaustive list or described conduit system is restricted to disclosed concrete form.When this paper describes the specific embodiments of embodiment of conduit system for exemplary purpose, can in the scope of the described conduit system that those skilled in the art will recognize that, carry out various equivalent modifications.The instruction of the conduit system that this paper provided can be applicable to other medical apparatus and instruments and system, and is not only above-mentioned conduit system.
The assembly of above-mentioned each embodiment and action can be made up so that other embodiment of conduit system to be provided.Can carry out these or other variation to described conduit system with reference to above-mentioned detailed description.
This paper is all incorporated in all above-mentioned lists of references and United States Patent (USP) and patent application by reference into.If desired, can change the various aspects of conduit system, using system, function and the notion of above-mentioned various patent and application, thereby provide other embodiment of described system.
Generally speaking, in claims, used term is not defined as described conduit system is restricted to disclosed particular in description and the claim, comprises all conduit systems and the medical apparatus and instruments that passes thromboembolism according to claim operation but should be defined as.Therefore, described conduit system is not subjected to the restriction of disclosed content, and the scope of described conduit system is determined by claim fully.
Though with specific claim formal representation the aspect of described conduit system, the inventor considers the various aspects of conduit system of the claim form of any amount.Therefore, the inventor is retained in the right of submitting to the application to increase other claim afterwards, to seek the other claim form of described conduit system others.

Claims (33)

1. conduit system comprises:
Catheter shaft, comprise the woven tubular assembly, wherein at least one internal layer polymer lining is connected to described woven tubular module inner, at least one outer layer copolymer lamination body is connected to described woven tubular module outer surface, and wherein the polymeric material of outer layer copolymer lamination body intersperses among among the described woven tubular assembly and is connected in the outer surface space of internal layer polymer lining; With
Be positioned at least one chamber of described catheter shaft, the distal end of wherein said catheter shaft chamber forms the annular opening that is positioned at described catheter shaft far-end, and described annular opening comprises internal layer polymer and the outer layer copolymer that forms atraumatic end.
2. system according to claim 1, wherein said outer layer copolymer lamination body comprises multiple polymers, wherein each forms along the one or more parts on the described catheter shaft length.
3. system according to claim 2, the measurement hardness number of wherein said part vertically reduces towards described catheter shaft distal direction.
4. system according to claim 1, wherein outer layer copolymer lamination body also comprises multiple polymers.
5. system according to claim 4, wherein multiple described polymer has different hardness numbers, and each of wherein said multiple polymers forms one or more zone of dispersions of outer layer copolymer lamination body.
6. system according to claim 5, wherein has the low zone of dispersion of measuring the polymer formation outer layer copolymer lamination body far-end of hardness number, have the zone of dispersion than the polymer formation outer layer copolymer lamination body near-end of high measurement hardness number, wherein the remote area of catheter shaft has than the relative higher flexibility of catheter shaft proximal end region.
7. system according to claim 4, wherein said multiple polymers comprise 6 kinds of polymer.
8. system according to claim 1, wherein said catheter shaft comprises the fluorescent labeling system.
9. system according to claim 8, wherein said fluorescent labeling system comprises first marked region that is positioned at described woven tubular assembly outside.
10. system according to claim 9, wherein said fluorescent labeling system comprises second marked region that is positioned at described woven tubular component internal.
11. system according to claim 1, also comprise the sleeve pipe conductor, described sleeve pipe conductor comprises having the assembly that near-end and far-end and formation are configured to follow the trail of the single chamber of leading line, wherein said assembly is configured to be inserted in the described catheter shaft, wherein when described assembly inserted fully, the remote area of described assembly stretched out outside the catheter shaft far-end.
12. system according to claim 11, wherein said sleeve pipe conductor also comprises at least one joint that is positioned at near-end, and described joint construction is for locking when described sleeve pipe conductor is inserted in the described catheter shaft fully in the joint on the catheter shaft near-end.
13. system according to claim 11, wherein said sleeve pipe conductor also comprises the fluorescent labeling system that is positioned at described assembly remote area.
14. conduit system comprises:
Catheter shaft, comprise the woven tubular assembly, wherein at least one internal layer polymer lining is connected to described woven tubular module inner, wherein at least one outer layer copolymer lamination body is connected to described woven tubular module outer surface, the polymeric material of wherein said outer layer copolymer lamination body intersperses among among the described woven tubular assembly and is connected in the outer surface space of internal layer polymer lining, wherein the internal layer polymer lining forms the chamber in the catheter shaft, the distal end of described catheter shaft chamber forms the annular opening that is positioned at described catheter shaft far-end, and described annular opening comprises internal layer polymer and the outer layer copolymer that forms atraumatic end; With
Conductor, comprise and have the assembly that near-end and far-end and formation are configured to follow the trail of the single chamber of leading line, wherein said assembly is configured to be inserted in the described catheter shaft, and wherein when described assembly inserted fully, the remote area of described assembly stretched out outside the catheter shaft far-end.
15. system according to claim 14, wherein said conductor also comprises at least one joint that is positioned at near-end, and described joint construction is for locking when described conductor inserts described catheter shaft fully in the joint on the catheter shaft near-end.
16. system according to claim 14, wherein at least one catheter shaft and conductor comprise the fluorescent labeling system that is positioned at described assembly remote area.
17. system according to claim 14, wherein said outer layer copolymer lamination body also comprises multiple polymers.
18. system according to claim 17, wherein multiple described polymer has different measurement hardness numbers, and each of wherein said multiple polymers forms one or more zone of dispersions of described outer layer copolymer lamination body.
19. system according to claim 18, wherein has the low zone of dispersion of measuring the polymer formation outer layer copolymer lamination body far-end of hardness number, have the zone of dispersion than the polymer formation outer layer copolymer lamination body near-end of high measurement hardness number, wherein the remote area of catheter shaft has than the relative higher flexibility of catheter shaft proximal end region.
20. conduit system comprises:
Sleeve pipe comprises catheter shaft, and described catheter shaft has at least one chamber and the end forms the annular opening that is positioned at described catheter shaft far-end, and described annular opening comprises internal layer polymer and the outer layer copolymer that forms atraumatic end; With
The intravascular tissue dilating catheter comprises
Conduit comprises the far-end and the longitudinal axis, and the described longitudinal axis has at least one pipeline that extends along the longitudinal axis;
Housing, be formed on described catheter shaft far-end, wherein said housing comprises by pivotally connected at least one yoke assembly that near-end limited and free distal end end to catheter shaft, described end is come the blood vessel dilating tissue with arc away from the longitudinal axis of described axle, and wherein said at least one yoke assembly comprises integrally formed hinge; With
Driver part is located so that the distal end of at least one yoke assembly leaves the longitudinal axis of described catheter shaft along catheter shaft.
21. system according to claim 20, wherein said at least one yoke assembly comprises one or more hinges.
22. system according to claim 20, wherein said driver part comprises the promotion assembly that is connected at least one yoke assembly.
23. system according to claim 22, wherein said at least one yoke assembly uses at least one hinge pin to be connected to housing, supports at least one hinge that at least one yoke assembly rotates to form when described push mechanism edge when the direction of near-end is pushed.
24. system according to claim 20, the measurement hardness number that wherein forms the material of trocar guide tube axle vertically reduces towards far-end.
25. system according to claim 20, wherein the trocar guide tube axle also comprises the woven tubular assembly, wherein at least one internal layer polymer lining is connected to described woven tubular module inner, at least one outer layer copolymer lamination body is connected to described woven tubular module outer surface, and wherein the polymeric material of outer layer copolymer lamination body intersperses among among the described woven tubular assembly and is connected in the outer surface space of internal layer polymer lining.
26. system according to claim 25, wherein outer layer copolymer lamination body comprises multiple polymers, and wherein each forms along the one or more parts on the described catheter shaft length.
27. system according to claim 26, wherein multiple polymers has different measurement hardness numbers, and each of wherein said multiple polymers forms one or more zone of dispersions of described outer layer copolymer lamination body.
28. system according to claim 27, wherein has the low zone of dispersion of measuring the polymer formation outer layer copolymer lamination body far-end of hardness number, have the zone of dispersion than the polymer formation outer layer copolymer lamination body near-end of high measurement hardness number, wherein the remote area of catheter shaft has than the relative higher flexibility of catheter shaft proximal end region.
29. system according to claim 20, wherein said telescopic catheter shaft comprises the fluorescent labeling system.
30. system according to claim 29, wherein said fluorescent labeling system comprise first marked region that is arranged in described woven tubular assembly outside and are positioned at second marked region at least a of described woven tubular component internal.
31. system according to claim 20, also comprise the sleeve pipe conductor, described sleeve pipe conductor comprises having the assembly that near-end and far-end and formation are configured to follow the trail of the single chamber of leading line, wherein said assembly is configured to insert in the described trocar guide tube axle, wherein when described assembly inserted fully, the remote area of described assembly stretched out outside the catheter shaft far-end.
32. system according to claim 31, wherein said sleeve pipe conductor also comprises at least one joint that is positioned at near-end, and described joint construction is for to lock in the proximal joint of described trocar guide tube axle when the sleeve pipe conductor inserts in the catheter shaft fully.
33. system according to claim 31, wherein said sleeve pipe conductor also comprises the fluorescent labeling system that is positioned at described assembly remote area.
CNB2004800198816A 2003-06-10 2004-06-10 Pass the conduit system and the method for blood vessel embolism Active CN100544787C (en)

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CN112057729A (en) * 2015-07-13 2020-12-11 Cti血管公司 Mechanically driven and functionally integratable catheter system for treating vascular and non-vascular diseases
CN107951539A (en) * 2018-01-16 2018-04-24 陈世辉 A kind of embolism embolus extractor
CN108042174A (en) * 2018-01-16 2018-05-18 陈世辉 A kind of withdrawing device for cerebral embolism embolus
CN109044483A (en) * 2018-07-26 2018-12-21 河南亚都实业有限公司 A kind of conduit for removal of thromboses

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