CN105228684A

CN105228684A - For length and the adjustable foley's tube of diameter of delivering medicament

Info

Publication number: CN105228684A
Application number: CN201380074562.4A
Authority: CN
Inventors: M.吉亚诺蒂
Original assignee: Abbott Cardiovascular Systems Inc
Current assignee: Abbott Cardiovascular Systems Inc
Priority date: 2013-03-12
Filing date: 2013-03-12
Publication date: 2016-01-06
Also published as: CR20150527A; WO2014142801A1; EP2968858A1

Abstract

A kind of adjustable foley's tube (100), described foley's tube comprises inner tubular element (110), and this inner tubular element comprises the inflation lumen (130) and fluid lumen (152) that are limited to wherein.Expansible elements (140) is coupled to distal portions and has and is limited to room in being communicated with described inflation lumen fluid wherein, and this expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has outer surface, and this outer surface has at least one orifice structure (141) be communicated with fluid lumen fluid be limited to wherein.This outer tubular member (120) can be moved relative to inner tubular element, this outer tubular member can move between extended position and punctured position, and this outer tubular member is positioned at extended position and punctured position selectively to limit the exposed length of the active length of expansible elements.

Description

For length and the adjustable foley's tube of diameter of delivering medicament

Technical field

Disclosed theme relates to the adjustable foley's tube being used for the treatment of patient bore's system.Specifically, disclosed theme relates to conduit, and it has can relative to the outer tubular member of inner tubular element movement, to limit the exposed length of expansible elements.

Background technology

The multiple pipe guide being used for the treatment of patient bore's system is as known in the art.Many all for treatment vascular system in such device, the cardiovascular system comprising patient is unified both peripheral system.Such as, the treatment of cardiovascular system can comprise the conveying of the execution of angioplasty or the interventional device (such as, support, filter, coil pipe) of Balloon-expandable or self inflation.The treatment of peripheral system can include but not limited to treatment carotid artery vascular, leg bending part blood vessel and Renal vascular and Venous system.

A kind of this type of cardiovascular system treatment comprises percutaneous transluminal coronary angioplasty (PTCA); Be used for the treatment of cardiopathic program.This program needs conduit tube component to introduce in the cardiovascular system of patient via brachial artery or femoral artery substantially, and makes conduit tube component be advanced through coronary vasculature, until the balloon portion on it is positioned through the diseased region of blocking.Once on the position passing diseased region, balloon inflation is radially compressed to preliminary dimension with the atheromatous plaque against diseased region, to transform blood vessel wall.Subsequently, sacculus discharge allows conduit tube component to take out from vascular system.

When treating peripheral system, conventional manifold is configured to the diseased region for the treatment of particular type, as short diseased region, Long lesion district, diffusion diseased region or focal change lesion.Therefore, required is select corresponding foley's tube to treat relevant diseased region in advance.But conventional manifold is not configured to treat multiple diseased region at one time.

In addition, the place in occluded lesions district only arrives by the zigzag channel of the vascular system through patient usually.It is enough flexible that difficulty close to this type of district needs that successful conduit must be had in the vertical, with along zigzag channel arrive desired by place, and simultaneously, have enough rigidity in the axial direction, to allow to promote from outside approximated position or the far-end of otherwise control lead.

In order to head it off, have developed the conduit along the vicissitudinous flexibility of its length tool.Such as, authorize Maguire No. the 4th, 782,834, United States Patent (USP) and authorize in No. the 5th, 370,655, the United States Patent (USP) of Burns each all disclose a kind of conduit with section along its length, section is formed by the material with different-stiffness; No. the 4th, 976,690, the United States Patent (USP) authorizing Solar discloses a kind of conduit with central waist part, which provides the flexibility of the increase along conduit axle; No. the 5th, 423,754, the United States Patent (USP) authorizing Cornelius discloses a kind of conduit in its distal portion office with larger flexibility, and this is caused by the dimensional transitions in material and axle; And No. the 5th, 649,909, the United States Patent (USP) authorizing Cornelius discloses a kind of conduit with the larger proximal part of band rigidity, this is applied thereto by polymer coating and causes.

These conventional methods and system are considered to gratifying substantially for its expection object.But, still continue in this area to need the vicissitudinous flexibility of a kind of tool to improve the conduit of the improvement of pushing away property, resisting longitudinal bendability and versatility.

Except PTA, PTCA and atheromatous plaque excision program, usually, adjustable foley's tube is used for the medium peripheral system of such as Venous system.Such as, first adjustable foley's tube moves forward sacculus to be positioned to contiguous stenotic lesion district on wire.Once in place, then balloon inflation, and the restriction of vascular is opened.Usually, foley's tube is configured with sacculus, and sacculus is fastened on the outside of hollow conduit axle at least at one end.The empty internal of sacculus and the empty internal of axle fluidly flowing relation.The fluid under stress thus inside of sacculus can be fed to via axle, to make sacculus expand against blockage.But be different from the sacculus for cardiovascular instruction, the sacculus for around instruction or treatment is longer in length substantially, such as, about 220mm or longer.

Catheter-balloon is generally fixing length and diameter, and this makes the sacculus needing to use different size, such as, with the diseased region of the vascular and variation length for the treatment of diameter change or bottleneck area.

Except foley's tube PTA, PTCA, atheromatous plaque excision and peripheral system program in above-mentioned use except, other foley's tube can be used for delivering therapeutic medicine or preparation.Such as, medicine can be coated on the outside of sacculus.But this layout does not just allow to select desired length or therapeutic dose on the surface being applied to sacculus.In addition, when this type of carrying method is for carrying the medicine of controlled volume to desired tissue location, treatment preparation can be wiped from the surface of sacculus during through the conveying of tortuous inner chamber system, or is otherwise lost in systemic circulation.

In view of above-mentioned, the foley's tube of a kind of improvement that required is, its have raising pushing away property and through property, foley's tube adjustable in vivo, and be positioned at the protectability of raising of any medicine on the expansible elements of foley's tube.The embodiment of disclosed theme provides the solution for these problems.

Summary of the invention

The object of disclosed theme and advantage will be illustrated and in the description that follows from being described clearly subsequently, and by by implementing disclosed theme to recognize.By the device particularly pointed out in written description and claim thereof and from accompanying drawing, by the attendant advantages of the theme disclosed in realization and acquisition.

In order to realize these and other advantage, and according to such as embodying and the object of broadly described disclosed theme, disclosed theme comprises adjustable foley's tube, adjustable foley's tube comprises inner tubular element, it has proximal part, distal portions and length therebetween, and inner tubular element also has the inflation lumen and fluid lumen that are defined in wherein.The distal portions and having that expansible elements is connected to inner tubular element is limited to room in being communicated with inflation lumen fluid wherein, and expansible elements can be changed between discharge configuration and inflation construct.This expansible elements also has the outer surface along its active length, and this outer surface has at least one orifice structure be communicated with fluid lumen fluid be limited to wherein.Outer tubular member can move relative to inner tubular element, outer tubular member comprises far-end, outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, outer tubular member is positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements.

Further according to another aspect of disclosed theme, provide a kind of adjustable foley's tube, it comprises inner tubular element, and inner tubular element has proximal part, distal portions and length therebetween, and inner tubular element also has the inflation lumen be limited to wherein.Expansible elements is connected on the distal portions of inner tubular element, and has and be limited to room in being communicated with inflation lumen fluid wherein, and expansible elements can be changed between discharge configuration and inflation construct.Expansible elements also has the outer surface along its active length, when being in inflation structure along the compartment of the active length of this expansible elements at least partially, described outer surface also has the relative beneficial agent releasing structure be communicated with compartment in described outer surface restriction.Outer tubular member can move relative to inner tubular element, outer tubular member comprises far-end, outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, outer tubular member is positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements.

Further according to another aspect of disclosed theme, provide a kind of method using one of adjustable foley's tube as herein described to carry beneficial agent.Such as, the method can comprise provides adjustable foley's tube, and this adjustable foley's tube comprises inner tubular element, and this inner tubular element has proximal part, distal portions and length betwixt.Inner tubular element also can have the inflation lumen and fluid lumen that are limited to wherein.Expansible elements is coupled to the distal portions of inner tubular element, and has and be limited to room in being communicated with inflation lumen fluid wherein, and expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has the outer surface along its active length, and this outer surface has at least one orifice structure be communicated with fluid lumen fluid be limited to wherein.Outer tubular member can move relative to inner tubular element, outer tubular member comprises far-end, outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, outer tubular member is positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements.The method also comprises: exposed length outer tubular member being shunk the active length to limit expansible elements along proximal direction, and makes the exposed length of expansible elements be inflated to inflation structure.The method also comprises: from least one orifice structure releasing beneficial agent described, and make expansible elements be disposed to discharge configuration.

Further according to the another aspect of disclosed theme, provide a kind of method using one of adjustable foley's tube as herein described to carry beneficial agent.Such as, the method can comprise provides adjustable foley's tube, this adjustable foley's tube comprises inner tubular element, and this inner tubular element has proximal part, distal portions and length betwixt, and inner tubular element also has the inflation lumen and fluid lumen that are limited to wherein.Expansible elements is coupled to the distal portions of inner tubular element, and has and be limited to room in being communicated with inflation lumen fluid wherein, and expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has the outer surface along its active length, when being in inflation structure along the compartment of the active length of this expansible elements at least partially, described outer surface also has the relative beneficial agent releasing structure be communicated with at least one compartment in described outer surface restriction.Outer tubular member can move relative to inner tubular element, outer tubular member comprises far-end, outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, outer tubular member is positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements.Described method also comprises: exposed length outer tubular member being shunk the active length to limit expansible elements along proximal direction, and utilizes the compartment along exposed length to make the exposed length of expansible elements be inflated to inflation structure.Beneficial agent is released to compartment from beneficial agent releasing structure, and expansible elements is disposed to discharge configuration.

It should be understood that above total volume description and following detailed description both exemplary, and aim to provide and require to obtain the further explaination of the disclosed theme of patent protection.

Included be incorporated to this description and the accompanying drawing forming the part of this description illustrates and provide the further understanding of the device of disclosed theme.Accompanying drawing is together with the description for explaining the principle of disclosed theme.

Accompanying drawing explanation

Figure 1A is the side view of the representative foley's tube of the inflation situation that is according to disclosed theme.

Figure 1B is the decomposition side view of the representative foley's tube of Figure 1A according to disclosed theme.

Fig. 2 is the sectional view of the conduit of Figure 1A that 2-2 along the line intercepts, and wherein inner tubular element has the coaxial configuration of the embodiment according to disclosed theme.

Fig. 3 is the sectional view with the inner tubular element of many tube conformation of another embodiment according to disclosed theme.

Fig. 4 is the schematic diagram with the conduit of multiple inflation port according to disclosed theme.

Fig. 5 A-5C is the image of the conduit according to disclosed theme, and wherein collapsible outer tubular member is optionally located to expose the various length of expansible elements according to the embodiment of disclosed theme.

Fig. 6 is the embodiment with the outer tubular member of braided polymer axle of the embodiment according to disclosed theme.

Fig. 7 is the schematic diagram with the outer tubular member of irrigation ports of the embodiment according to disclosed theme.

Fig. 8 A-8D is the illustrative diagram picture of the conduit of embodiment according to disclosed theme, and wherein collapsible outer tubular member is optionally located to expose various length and the respective diameters of expansible elements.

Fig. 9 is the partial side view in cross section of the far-end of the adjustable foley's tube for carrying beneficial agent according to disclosed theme.

Figure 10 is the partial side view in cross section of the far-end of the adjustable foley's tube for carrying beneficial agent of another embodiment according to disclosed theme.

Figure 11 A is the sectional view of the inner tubular element of Figure 10 that 11-11 along the line intercepts, and wherein inner tubular element has coaxial configuration according to the embodiment of disclosed theme.

Figure 11 B is the alternative in the cross section of the inner tubular element of Figure 10 that 11-11 along the line intercepts, and wherein inner tubular element has many cavity arrangements according to the embodiment of disclosed theme.

Figure 12 is the partial side view in cross section of the far-end of the adjustable foley's tube for carrying beneficial agent of another embodiment according to disclosed theme.

Figure 13 is the partial section substantially with the far-end of the adjustable foley's tube of multiple expansible elements of another embodiment according to disclosed theme.

Figure 14 is the sectional view of the adjustable foley's tube of another embodiment according to disclosed theme.

Figure 15 and 16 is schematic diagrams that outer tubular member is in the distal sections of the conduit of extended position and punctured position respectively, and wherein outer tubular member has distal marker according to the embodiment of disclosed theme.

Figure 17 and 18 is the schematic side elevations being in partial cross section's form of the embodiment of the distal tip of the conduit of punctured position and extended position respectively according to disclosed theme.

Figure 19 A-19C is the illustrative diagram picture of the alternative of the distal tip of conduit according to disclosed theme.

Figure 20 is the schematic section side view with the far-end of the conduit of ladder marker of another embodiment according to disclosed theme.

Figure 21 is the schematic side elevation with the far-end of the conduit of the expansible elements arranged with alternate labels of the embodiment according to disclosed theme.

Detailed description of the invention

As disclosed herein, the device illustrated herein can be used for the inner chamber system for the treatment of patient.Disclosed theme is particularly suitable for carrying beneficial agent, for cardiovascular system and/or the peripheral system for the treatment of patient.The treatment of cardiovascular system can comprise angioplasty or the conveying of the intervention device (such as, support, filter and coil) performing Balloon-expandable or self-expanding.The treatment of peripheral system is including, but not limited to treatment carotid artery vascular, leg bending part blood vessel and Renal vascular.Therefore, current disclosed theme is also suitable for various concrete Ink vessel transfusing blood vessel.

According to an aspect of disclosed theme, provide a kind of adjustable foley's tube.Adjustable foley's tube comprises inner tubular element, and this inner tubular element comprises proximal part, distal portions and length betwixt, and described inner tubular element also comprises the inflation lumen and fluid lumen that are limited to wherein.Expansible elements is connected on the distal portions of inner tubular element, and has the interior room be limited to wherein, and this interior room is communicated with inflation lumen fluid, and described expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has the outer surface along its active length, and described outer surface has at least one orifice structure be communicated with fluid lumen fluid be limited to wherein.Outer tubular member can move relative to inner tubular element, and outer tubular member comprises far-end, outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, outer tubular member can optionally be positioned between extended position and punctured position, to limit the exposed length of the active length of expansible elements.

Further according to the another aspect of disclosed theme, adjustable foley's tube comprises inner tubular element, and this inner tubular element has proximal part, distal portions and length betwixt, and described inner tubular element also has the inflation lumen be limited to wherein.The distal portions that expansible elements is coupled to inner tubular element has and is limited to room in being communicated with inflation lumen fluid wherein, and this expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has the outer surface along its active length, when being in inflation structure along the compartment of the active length of this expansible elements at least partially, described outer surface also has the relative beneficial agent releasing structure be communicated with compartment in described outer surface restriction.Outer tubular member can move relative to inner tubular element, described outer tubular member comprises far-end, described outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, and described outer tubular member can optionally be positioned between extended position and punctured position to limit the exposed length of the active length of expansible elements.

Further according to the another aspect of disclosed theme, there is discussed herein and use one of them adjustable foley's tube to carry the method for beneficial agent.Such as, described method can comprise provides adjustable foley's tube, and this adjustable foley's tube comprises the inner tubular element with proximal part, distal portions and length betwixt.Described inner tubular element also can comprise the inflation lumen and fluid lumen that are limited to wherein.The distal portions and having that expansible elements is coupled to described inner tubular element is limited to room in being communicated with inflation lumen fluid wherein, and this expansible elements can conversion between discharge configuration and inflation structure.This expansible elements also has the outer surface along its active length, and described outer surface has at least one orifice structure be communicated with fluid lumen fluid be limited to wherein.Outer tubular member can move relative to inner tubular element, and this outer tubular member comprises far-end, and this outer tubular member can move at the extended position be arranged on extensible parts and between the punctured position of the nearside of extended position.Described outer tubular member is optionally positioned between extended position and punctured position to limit the exposed length of the active length of expansible elements.The method also comprises: make outer tubular member shrink the exposed length of the active length to limit expansible elements along proximal direction; And make the exposed length of expansible elements be inflated to inflation structure.The method also can comprise: from least one orifice structure releasing beneficial agent; And expansible elements is released to discharge configuration.

Further according to the another aspect of disclosed theme, there is discussed herein and use one of them adjustable foley's tube to carry the method for beneficial agent.Such as, described method can comprise provides adjustable foley's tube, and this adjustable foley's tube comprises the inner tubular element with proximal part, distal portions and length betwixt, and this inner tubular element also has the inflation lumen and fluid lumen that are limited to wherein.The distal portions and having that expansible elements is coupled to described inner tubular element is limited to room in being communicated with inflation lumen fluid wherein, and this expansible elements can conversion between discharge configuration and inflation structure.This expansible elements also has the outer surface along its active length, when being in inflation structure along the compartment of the active length of expansible elements at least partially, described outer surface also has the relative beneficial agent releasing structure be communicated with at least one compartment in described outer surface restriction.Outer tubular member can move relative to inner tubular element, this outer tubular member has far-end, this outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of the nearside of extended position, and described outer tubular member is optionally positioned between extended position and punctured position to limit the exposed length of the active length of expansible elements.The method also comprises: make outer tubular member shrink the exposed length of the active length to limit expansible elements along proximal direction; And utilize the compartment along exposed length to make the exposed length of expansible elements be inflated to inflation structure.Beneficial agent to be released to compartment and expansible elements is disposed to discharge configuration from beneficial agent releasing structure.

With detailed reference to the embodiment of disclosed theme, its example is illustrated in the accompanying drawings.Illustrating of coupling system is described by disclosed theme.

For explain and set forth object but not for restriction object, schematically show the embodiment of adjustable foley's tube in figure ia, being transferred in this vascular system at least partially of this foley's tube.Figure 1B is the exploded view of Figure 1A.Particularly and as directed, adjustable foley's tube 100 comprises inner tubular element (or conduit axle) 110, and it has proximal part, distal portions and length betwixt.Inner tubular element 110 can comprise various suitable constructions.Such as but do not limit, in one embodiment, inner tubular element can comprise seal wire sacculus (OTW) structure.In this embodiment, inner tubular element comprises the guide wire lumen 150 of the entire length extending substantially through inner tubular element.Wire 160 can with in known usual manner lead-in conductor inner chamber 150.

As alternative, conduit can be configured with and exchange structure (RX) fast.In this embodiment, guide wire lumen 150 extends to the proximal part distad isolated proximal guidewire port from inner tubular element.In OTW structure or RX structure, inner tubular element can be provided with coaxially arranged or many cavity arrangements.In addition, inner tubular element can be single pipe, or the assembly of the compartment be linked together along its length.For object for example and not limitation, be presented as that the inner tubular element for the conduit of peripheral vascular purposes comprises L12 axle herein, it has the external diameter of about 1.08mm and the length of about 120cm.Person of skill in the art will appreciate that, other structure and known configuration material can be used when not departing from the scope of disclosed theme.

Such as, and as shown in Figure 2, the unrestriced object for illustrating, provides coaxially arranged typical cross section view.Viewgraph of cross-section intercepts along the line 2-2 in Figure 1A.In this way, inner tubular element also can comprise the conduit 151 guide wire lumen 150 be defined in wherein, and is limited to the inflation lumen 130 between inner tubular element 110 and conduit 151 circlewise.In addition, guide wire lumen can be formed by the thin film of applicable intensity, penetrates therebetween and reduce the increase of the cross-sectional profiles of inner tubular element to greatest extent to prevent wire.As alternative, conduit 151 can be multilamellar configuration, as but be not limited to, nylon-L25 layer, tack coat are as Prim, and high density polyethylene (HDPE) (HDPE) layer.

According to another embodiment, as shown in Figure 3, inner tubular element can be many cavity arrangements.Such as but not limited to, inner tubular element 110 can be the global facility with many cavity arrangements.In this embodiment, inflation lumen 130 and guide wire lumen 150 are defined in wherein by inner tubular element 110.Guide wire lumen 150 allows conduit 100 to carry on wire 151.

In any embodiment, inner tubular element 110 comprises outer surface 111, and inflation lumen 130 is defined in wherein.As further discussed below, inflation lumen is communicated with the interior room fluid of expansible elements 140.Inflation lumen 130 is defined for the path that fluid is advanced along inner tubular element 110, no matter whether fluid can be introduced in inflation lumen 130 in the proximal end of conduit 100 via Rule adapter etc.Inflation lumen 130 can feed inflation medium at a positive pressure, and can from expansible elements such as by negative pressure sucking-off inflation medium.Therefore, as further discussed below, expansible elements inflatable and discharge.

In an alternative embodiment, inflation lumen and guide wire lumen combine and comprise single shared inner chamber.Coaxially arranged for this type of, fluid therefore can the intracavity flowing in sharing when wire 151 is positioned wherein.In this class formation, inner tubular element 110 can comprise in order to engage the proximal guidewire sealing member and distal guidewire sealing member that are arranged on wire 151 in inflation lumen hermetically.The inner chamber shared also can have independent or except sealing member stop part at far-end, and with the far-end allowing wire to be advanced past conduit, and anti-fluid spills shared inner chamber.Sealing member or stop part provide the recess allowing wire to extend in guide wire lumen.This type of coaxial configuration allows the diameter reducing inner tubular element, and therefore reduces profile.

As shown in Figure 1A further, adapter or manifold 101 can be located at the proximal end of conduit, for close to inflation lumen, and are configured for being connected on fluid source (not shown).Manifold can have Y shape, and the luer connector wherein in the proximal end of a branch is in order to receive fluid source, and the independent haemostatic valve in another branch is in order to receive wire.Conventional equipment such as, but not limited to charge and discharge device (indeflator) or syringe can be connected on luer connector introduces inflation lumen by fluid.Locking mechanism also can be provided as the operating position of locking charge and discharge device or syringe.

Charge and discharge device or other fluid source can be configured to the inflation and the discharge that control expansible elements.Charge and discharge device can be provided with piezometer to monitor and/or keep the pressure system of conduit.Charge and discharge device can allow rapid pressure to discharge equally.Charge and discharge device can have the locking mechanism in order to negative pressure to be kept in the catheter, and it can reduce the profile of conduit.The size of conduit and structure be defined as at bodily lumen as carried in vascular system, and particularly through tortuous tissue.

As mentioned before, expansible elements is connected on the distal portions of inner tubular element, as shown in Figure 1A.Expansible elements 140 or sacculus as shown here have outer surface and inner surface.The inner surface of expansible elements limits the interior room be communicated with inflation lumen 130 fluid of inner tubular element.According to an aspect, inner tubular element can extend through expansible elements at least in part.The unrestriced object for illustrating, Fig. 4 shows the inner tubular element of the whole length extending expansible elements.As used herein as embodied, multiple inflation port 601 can be limited in inner tubular element along the active length of extensible parts, to guarantee to be communicated with the fluid of interior room 35.Multiple inflation port provides inflation and the discharge of the reinforcement of expansible elements by constricted zone.

Expansible elements 140 can be changed between discharge configuration and inflation construct.As described further below, outer tubular member 120 is shunk along proximal direction with the exposed length limiting expansible elements.Expansible elements has total length, has the active length at least partially extending total length.Expansible elements limits longitudinal axis, and can have the non-cylindrical at least partially along its active length when being in inflation structure.As embodied herein, unrestricted in order to illustrate, along the bodily lumen be configured at least partially in order to be in joint patient when inflation constructs at expansible elements of the outer surface of the expansible elements of active length.

According to an aspect of disclosed theme, multiple difformity can be used for expansible elements, and wherein the shape of expansible elements can be depending on desired application, as will be described below.

As previously disclosed, conduit also comprises outer tubular member or sheath.Such as, and as unrestricted in order to illustrate and embodying, Figure 1A, Figure 1B and Fig. 2 show outer tubular member 120, and it has near-end, far-end, certain length, and inner surface 121.Inner tubular element 110 is positioned in outer tubular member 120 at the far-end of conduit 100, makes the outer surface 111 of inner surface 121 direction towards inner tubular element 110 of outer tubular member 120.Outer tubular member 120 can move relative to the length of inner tubular element 110 along inner tubular element 110.Such as, outer tubular member 120 can be shunk along direction A towards the near-end of conduit or distad extend.Outer tubular member 120 can be arranged on the distal portion office of conduit, or the total length of extensible conduit.Outer tubular member has the length at least equaling expansible elements 140 length.

Outer tubular member 120 can move at the extended position be arranged on expansible elements 140 and between the punctured position of the nearside of extended position relative to inner tubular element 110.The active length of expansible elements represents the greatest length can exposed outside outer tubular member.As discussed further herein, outer tubular member is positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements.In addition, as further described herein, outer tubular member is positioned to adjust rigidity characteristic and/or flexibility selectively along the length of conduit selectively.

For explaining and illustrating and unrestriced object, Fig. 5 A to Fig. 5 C depicts the schematic diagram of the typical catheter according to disclosed theme.Adjustable outer tubular member 120 is positioned to the various length exposing expansible elements selectively.Fig. 5 A depicts and shrinks the first distance D1 to expose the adjustable outer tubular member 120 of the first exposed length L1 of the active length of expansible elements along proximal direction A.Fig. 5 B depicts and shrinks second distance D2 to expose the adjustable outer tubular member 120 of the second exposed length L2 of the active length of expansible elements.Fig. 5 C depicts contraction the 3rd distance D3 to expose the adjustable outer tubular member 120 of the 3rd exposed length L3 of the active length of expansible elements.Outer tubular member is shunk larger, then the length of balloon part can exposed is larger.

Multiple actuator can be used for outer tubular member is moved between punctured position and extended position.Such as, move by drawing handle assembly or otherwise actuate the near-end of outer tubular member.Outer tubular member is also by using as United States Patent (USP) 7,780,716 and 7,799,065 and U.S. Patent Application Pub.No 2005/0182475 and 2007/0191864 disclosed in actuator extend and shrink, the content of these documents is incorporated into herein with its entirety.

Outer tubular member can be provided with less constant cross section or diameter.As alternative, outer tubular member can limit the first external diameter in its proximal end, and limits the second different external diameters at its far-end.First diameter can be less than Second bobbin diameter, or vice versa.Such as, and according to the embodiment of disclosed theme, outer tubular member can have first diameter of about 4French and the Second bobbin diameter of about 5French, but these sizes can be depending on desired application and change.

According to this aspect of disclosed theme, step can be provided as the change of the diameter between near-end and far-end allowing outer tubular member.Step allows the change of diameter to depend on application and appears at along the longer distance of outer tubular member or comparatively in short distance.As alternative, if expected, taper more gradually can be provided.

During expansible elements is delivered to objective via the bodily lumen of patient, outer tubular member 120 protects any coating on expansible elements 140 and expansible elements or treatment preparation, as described further below.In in of disclosed theme, outer tubular member can prevent medicine from discharging from the surface of expansible elements before being configured at desired place, made to reduce drug loss to greatest extent.Outer tubular member can be used for protecting the coating for the treatment of preparation to avoid discharging from expansible elements during adjustable foley's tube moves through bodily lumen.In addition, outer tubular member also can shipment before use and protective finish between the storage life.

In the another aspect of disclosed theme, the inner surface of outer tubular member is also formed as having heterogeneous surface, and as being formed at repeat patterns wherein, pattern forms the sinusoid pattern around the circumference of tubular part.By forming surface in this way, the frictional force between the inner surface of outer tubular member and the outer surface of expansible elements contacts by the continuous surface formed between contact point instead of two surfaces between these two surfaces and reduces.Many contact points reduce the friction between outer tubular member and expansible elements, thus need less power to shrink to make outer tubular member during use.Outer tubular member can be fabricated to single part or manufacture more than one element.

The material that outer tubular member can be applicable to by monolayer is formed.Such as, the material be applicable to can include but not limited to polymeric material, as the polyethylene of nylon, urethanes, polyurethanes, PEEK, PTFE, PVDF, Kynoar, PE, HDPE, the trilaminate material comprising L25, Plexar or various applicable density.The thickness of monolayer can change along the length of length-adjustable conduit.As alternative, the thickness of monolayer can remain constant.

According to another aspect of disclosed theme, outer tubular member can comprise multi-layer part, and such as comprises skin and internal layer.Internal layer can be attached to above outer or be formed together with skin.Such as, multilamellar can be formed in multiple applicable mode, includes but not limited to formed separately and adhere to or be bonded together, or jointly extrudes as single parts.Internal layer or lining can comprise lubriation material, so that make outer tubular member slide along proximal direction when outer tubular member is shunk.Such as, the dissimilar polymer of such as PTFE or high density polyethylene (HDPE) (HDPE) can be used for internal layer.In addition, the lubricious polymeric thing that other is applicable to can be used.If expected, then the internal layer of outer tubular member can be formed as the vicissitudinous wall thickness of tool.Such as, wall thickness can be greater than in proximal end at far-end.Independent or enough intensity can be provided to be clamped on wherein by medical treatment device with the skin of inner-layer combination, and allow the movement between extended position and punctured position.In addition, outer tubular member has enough axial strengths or rigidity, with as desired and improve the pushing away property of conduit as further described below like that.

Further according to disclosed theme, outer tubular member can comprise enhancement layer, and as braided material, it is arranged between skin and internal layer.Such as, enhancement layer can be provided as the form of the braiding stainless steel silk with rectangle or other flattened cross-sectional.Other weaving material or braided material can be used equally, as being enclosed in the carbon fiber in polymeric matrix.Equally, during manufacture process, fortifying fibre can be attached between internal layer and/or skin in addition or alternatively or be attached in internal layer and/or skin.Enhancement layer need not be present in the whole length of outer tubular member.And according to another aspect of disclosed theme, enhancement layer can provide along the selected portion of outer tubular member or inner tubular element or change, to change flexibility and/or rigidity characteristic thus in fact.Such as, enhancement layer can only provide along the portions of proximal of outer tubular member.In one embodiment, the unrestriced object for illustrating, outer tubular member can comprise the braiding enhancement layer of 304V stainless steel silk of the PTFE internal layer of the internal diameter with 1.14mm, the 0.0254mmx0.0762mm of 25PIC, and the nylon of the internal diameter with 1.265mm is outer.

According to the embodiment of disclosed theme, outer tubular member can have the wall thickness of about 6.0mil, and wherein internal layer and enhancement layer have the thickness of about 2.0mil, and skin has the thickness of about 4.0mil.Wherein above size is provided as example, and should not regard as and limit by any way.

When outer tubular member is provided with internal layer, skin and enhancement layer, outer tubular member can be formed in the following manner.First, internal layer is formed by pipe expressing technique, and arranges around forming mandrel (not shown).Forming mandrel can have the shape corresponding to shape desired by inside outer tubular member.Enhancement layer can provide with the form of rustless steel braided material, and is positioned on the predetermined length of internal layer, and such as, the distal part of internal layer still can be can't help reinforcing material and be covered.Then, skin is extruded on enhancement layer.Outer can provide with the form of two independent tubular parts, tubular part overlaps on enhancement layer slightly in its end.Outer field various piece can be the different materials being chosen as to provide different hardness as desired.Outer field two parts can be overlapping a certain amount of, e.g., but is not limited to about 2.0MM to 2.5MM.Next, the sleeve of heat-shrinkable material is positioned on whole outer tubular member assembly.When heat is applied on assembly, heat-shrinkable pipeline reduces, and therefore makes internal layer fuse with outer, thus enhancement layer is betwixt clamping.Heating process also makes internal layer meet the shape of forming mandrel.Therefore, if expect to have the outer tubular member of the diameter of the vicissitudinous and/or step of tool as described above, then axle can correspondingly be formed.After assembly cooling, heat-shrinkable pipeline is cut off, and leaves outer tubular member 120.

The inner tubular element of adjustable foley's tube and outer tubular member can be single-piece configuration respectively, or are the assembly of compartment, and can be made up of any applicable material.Such as, the material be applicable to includes but not limited to polymeric material, as the polyethylene of nylon, urethanes, polyurethanes, PEEK, PTFE, PVDF, Kynoar, PE, HDPE, the trilaminate material comprising L25, Plexar or various applicable density.As another alternative, outer tubular member can be made up of composite, and composite comprises the some different materials of manufacture, as jointly extruding of different polymer, or fibre reinforced composites, as fibre reinforced resin material or braided material.Such as but not limited to, as mentioned before, exemplary embodiment can comprise the braided tube with PTFE lining, the polyamide intermediate layer with braid, and Pebax72D is outer.In addition, a part for inner tubular element and/or outer tubular member can be made up of alloy or metal material, and as stainless steel sheet| hemostasis pipeline, it can obtain from the MicroGroup Inc. (Medway, MD) distributors.Other material for outer tubular member comprises: PEEK; The trilaminate material of L25, Plexar, HDPE; Or braided tube, it has PTFE lining, has the polyimides intermediate layer of braid, and Pebax72D is outer.

Also envision inner tubular element and outer tubular member can be made up of other biocompatible material.Therefore, the inner tubular element of adjustable foley's tube and outer tubular member can by the combination of the polymer pointed out above, these polymer or mixture (individually or with other combination of materials), or other bioabsorbable material is formed.

Inner tubular element and outer tubular member can use multiple known technology manufacture, as but be not limited to those technology of discussing above, and extrude, injection molding, blow, stretch, deep-draw, polymerization, crosslinked, leaching solution, powder deposition, sintering, electrostatic spinning, melt spinning, be out of shape at temperature, stretch blow, by any combination above with strengthen element (as, braided metal, coil pipe, glass fibre, the organic fiber of carbon fiber and other type or inorfil, liquid crystal) chemical graft, and the process technology of classics, as milling, boring, grinding etc.When by conjunction with hardware as hypotube, various metal fabrication techniques can be used, as but be not limited to, processing, tube-pulling craft, boring, milling EDM, other deformation method, coating sputtering, electric grafting, sintering and deposition electro-polish etc.In addition, inner tubular element and/or outer tubular member can be made up of by using the expressing technique of extruder polypropylene or urethanes, extruder be such as multiple known supplier (as, MedicalExtrusionTechnologiesInc. any available extruder (Murrieta, the Calif. U.S.)).Biosynthesis polymeric material can according to United States Patent (USP) the 6th in bioreactor, and technique disclosed in 495, No. 152 is formed, and the full content of this patent is incorporated herein by reference.Material can post processing in a plurality of ways, comprises, such as, is not limited to, extrude, molded, and as by injecting or immersing, weaving process is as weaved or weaving, and shaping.Only lift several example, accommodable formation process is by material piece or the roll extrusion of vacuum forming sheet and is welded into tubular form.

Inner tubular element and outer tubular member also can be coated with any one in multiple material, and the technology of carrying out for improving performance (if expectation), comprise the multiple applicable coating and coating technique that belong to the patent had by AbbottLaboratories, as United States Patent (USP) the 6th, 541, No. 116, United States Patent (USP) the 6th, 287, No. 285 and No. 2002/0009535th, U.S. Patent Bulletin, the full content of all these documents is incorporated herein by reference.Such as, possible coating material comprises lubriation material, as can from DuPontDeNemours (Wilmington, DE, the U.S.) Teflon that obtains, and hydrophobic material, as can from AppliedSiliconeCorp (Ventura, CA, the U.S.) the silicone lubricant suspension PN4097 that obtains, or hydrophilic material, as can from Hydromer (Branchburg, NJ, the U.S.) hydrogel that obtains, or lubricant coating, as can from Hydro-Silk (MerrittIsland, FL, U.S.) obtain those.Inner tubular element and outer tubular member can have any applicable cross sectional shape, comprise ellipse, polygon or prismatic, but circular cross-section are conventional.Inner tubular element and outer tubular member also can be depending on desired application and have any applicable size and diameter.In addition, when having the foley's tube of " exchanging fast " (RX) traverse design, adjustable foley's tube can have the total length between about 110 centimetres to 400 centimetres.When having the foley's tube of " on line " (OTW) traverse design, adjustable foley's tube can have the total length between about 110 centimetres to 400 centimetres.In one embodiment, according to the 4French introducer sheath BTK balloon-system that the adjustable foley's tube of disclosed theme is compatible.

According to another aspect of disclosed theme, for illustrating, unrestriced object is referring to Fig. 6, shows the alternative of outer tubular member 120.(such as, distal portions) as shown in the figure at least partially of outer tubular member is formed by the braided polymer sleeve at its far-end with labelling 801.Braided polymer sleeve increases the flexibility of outer tubular member and soft.In addition, in order to improve flexibility, helical plastic can be used for the structure of outer tubular member.Labelling can be radiopaque becket or is applicable to other parts of desired use.As alternative, labelling can use the polymer plastic for improving soft loading tungsten to form.As discussed further herein, the known labelling that other is applicable to can be used.

In another embodiment of disclosed theme, as shown in Figure 7, irrigation lumen 170 is limited between inner tubular element and outer tubular member.According to another aspect, as shown in Figure 7, outer tubular member comprises at least one irrigation ports 901 be defined in therebetween, and it is communicated with irrigation lumen fluid.Such as, but not limited to the fluid of contrast agent or treatment preparation by the adapter that is communicated with irrigation lumen to introduce in irrigation lumen.Contrast agent or preparation can leave irrigation lumen 170 via at least one irrigation ports 901.

According to the another aspect of disclosed theme, conduit has rigidity characteristic and flexibility, at least one wherein in rigidity and flexibility is adjusted, as what discuss in more detail in the PCT application PCT/US2011/052014 be incorporated herein in full relative to the chosen position of inner tubular element selectively by outer tubular member.

Refer again to expansible elements, should be understood that, discuss in detail in 2009/0105686 as announced in the U.S. of " Adjustable-LengthDrugdeliveringBalloon " by name, can adopt various suitable shape and material, the document is incorporated herein in full.

Such as, according to an embodiment, expansible elements can comprise the cylindrical form of the part along active length being in inflation structure.In other embodiments, sacculus can have other suitable shapes, such as non-cylindrical, as PCT/US2011/052018 herein discusses in more detail being incorporated in full.

For explaining and describing and unrestriced object, Fig. 8 A-8D shows the schematic diagram under inflation situation with conical butt, the substantially expansible elements of taper or tapered shape, and wherein narrow section is positioned at the far-end of expansible elements.The external diameter of the expansible elements of this embodiment increases towards the near-end of expansible elements.In this way, the exposed length that the overall diameter of expansible elements when inflation can be depending on expansible elements is selected.That is, as described further below, by shrinking outer tubular member 120, the external diameter of expansible elements based on expansible elements selection exposed length and can be adjusted.Such as, if external diameter is about 6mm in proximal end, and be decreased to about 2mm at balloon distal place, if then only expose the half of active length, the overall diameter in proximal end will be about 4mm.Therefore, the overall diameter of expansible elements is chosen as the maximum gauge of exposed length.

Fig. 8 A shows the outer tubular member 120 extended completely at extended position.Fig. 8 B and Fig. 8 C shows and is positioned at punctured position selectively with the outer tubular member of the various length and diameter of exposing expansible elements.In this embodiment, when outer tubular member is shunk, expansible elements is diameter increase in inflation structure due to the taper configurations of expansible elements.Fig. 8 D shows the outer tubular member of shrinking further.The length of expansible elements can be depending on desired application and desired use and changes.Therefore, by shrinking outer tubular member selectively to adjust length and the diameter of expansible elements.Person of skill in the art will appreciate that, expansible elements can be formed with unshowned various difformity and size, and this does not depart from the scope of disclosed theme.

Although not shown, the sacculus of disclosed theme can have folding non-inflation structure, and its wing centre section holds sacculus to be formed for introducing intracavity in patient body and the low-profile configuration of intracavity reach in patient body.As a result, sacculus is inflated to nominal operation diameter by the molded volume launched and fill sacculus.According to another aspect of disclosed theme, expansible elements can construct relative to outer tubular member, to make the total length of expansible elements expose completely.In this way, when outer tubular member is shunk as described below like that completely, the near-end of expansible elements can not expose, to allow outer tubular member distad move relative to inner tubular element or return.Therefore, folding sacculus structure can be used for expansible elements.Such as, when outer tubular member is in extended configuration and is positioned on expansible elements, expansible elements is in the folding layout in outer tubular member.When outer tubular member shrink and expansible elements inflation time, the active length not refolding of expansible elements.But the proximal part of expansible elements will remain in outer tubular member, and wherein portions of proximal is folded in outer tubular member.Therefore, the folding portions of proximal of expansible elements be convenient in expansible elements discharge and outer tubular member distad mobile after make expansible elements refolding.

For example purposes, can be used for the length of balloon relatively grown as disclosed herein for the conduit of refolding and method, as around sacculus.For example purposes, in one embodiment, expandable parts are long ball capsule, and have the length of about 220mm.The roughly maximum functional length of expansible elements can be about 200mm, and the roughly folding portions of proximal of expansible elements can be about 20mm.Equally, refolding technology can use, as about 120mm in conjunction with the expansible elements with short length.In this embodiment, the maximum functional length of expansible elements can be about 100mm, and the roughly folding portions of proximal remained in outer tubular member can be about 20mm.

Shrink to prevent outer tubular member and exceed desired active length, can stop mechanism be used.Such as but not limited to, be configured to the further movement preventing outer tubular member in order to conduit Rule parts of the near-end against outer tubular member or the far-end of other parts, wherein the near-end of expansible elements still by outer tubular member distal portions cover.

Expansible elements can be formed by multiple applicable material.Multiple applicable material can be used for the expansible elements according to disclosed theme.Such as, expansible elements can be made up of polymeric material, comprises compliance, half compliance or non-compliance polymeric material or polymeric blends.

In one embodiment, polymeric material is polyamide/polyether block copolymer (being commonly referred to PEBA or polyether block copolymer).Polyamide and the polyethers sections of block copolymer carry out bonding by amide or ester bond.Polyamide-block can be selected from various fatty polyamide as known in the art or aromatic polyamides.More aliphatic limiting examples comprise nylon 12, nylon 11, nylon 9, nylon 6, nylon 6/12, nylon 6/11, nylon 6/9 and nylon 6/6.In one embodiment, polyamide is nylon 12.Polyether block can be selected from various polyethers as known in the art.Some limiting examples of polyethers sections comprise poly-(tetramethylene ether), tetramethylene ether, Polyethylene Glycol, polypropylene glycol, poly-(Pentamethylene. ether) and poly-(cyclohexane-ether).Also commercially available PEBA material can be used, such as, as the PEBAX material that Arkema (France) supplies.In addition, sacculus grillamid can be used as the material for expansible elements.As known in the art for being formed the various technology of sacculus by polyamide/polyether block copolymer.Authorize in No. the 6th, 406,457, the United States Patent (USP) of Wang and disclose this type of example, the disclosure of this patent is incorporated herein with its entirety by reference.

In another embodiment, expansible elements is formed by polyamide.Polyamide can have larger tensile strength, even anti-pin-holing after folding and launching, and anti-scratch substantially, as authorized the United States Patent (USP) the 6th of Pinchuk, disclosed in 500, No. 148 those, the disclosure of this patent is incorporated herein with its entirety by reference.Some limiting examples being applicable to the polyamide material of sacculus comprise nylon 12, nylon 11, nylon 9, nylon 69 and nylon66 fiber.For form non-compliance sacculus other be applicable to material be polyester, e.g., polyethylene terephthalate (PET), Hytrel thermoplastic polyester and polyethylene.

In another embodiment, sacculus by polyurethane material as TECOTHANE (Thermedics) is formed.TECOTHANE is the thermoplastic aromatic's polyether polyurethane synthesized by methylene thiophenol (MDI), polytetramethylene ether diol (PTMEG) and the agent of Isosorbide-5-Nitrae chain expansion of succinic acid.TECOTHANE 1065D level can be used, and has the Shore hardness of 65D, the extension at break of about 300%, and the higher breaking strength of about 10,000psi.But the grade that other can be used to be applicable to, comprises the TECOTHANE 1075D of the Shore D hardness with 75.Other compliance polymeric material be applicable to comprises ENGAGE (DuPontDowElastomers (ethylene alpha-olefin polymer)) and EXACT (ExxonChemical), both thermoplastic polymers.Other conforming materials be applicable to includes but not limited to elastomer silicone resin, latex and urethanes.

Conforming materials can be crosslinked or noncrosslinking, and this depends on balloon material needed for application-specific and feature.Polyurethane balloon material is not cross-linked.But other material crosslinkable be applicable to, as polyene adoption compound ENGAGE and EXACT.By making sacculus conforming materials be cross-linked, final balloon inflation size can be controlled.Conventional crosslinking technological can be used, comprise heat treatment and electron beam exposure.After crosslinking, first pressurize, expand and preshrunk, sacculus will be expanded to reproducible diameter in response to given inflation pressure subsequently in a controlled manner, and thus avoids inflation to non-desired larger diameter.

In another embodiment, sacculus is formed, as silicones-polyurethane co-polymer by low stretcher strain polymer.Silicones-polyurethanes can be ether urethanes, and be more specifically aliphatic ether urethanes, as PURSILAL575A and PURSILAL10 (PolymerTechnologyGroup), and ELAST-EON3-70A (Elastomedics), it is silicones polyether urethane copolymer, and is more specifically aliphatic ether urethanes copolymerized siloxanes.In an alternative embodiment, low stretcher strain polymer is diene polymer.Multiple applicable diene polymer can be used, as but be not limited to, isoprene, as AB and ABA poly-(styrene-b-isoprene), neoprene, AB and ABA poly-(styrene-b-butadiene), as styrene butadiene styrene (SBS) and butadiene-styrene rubber (SBR) and 1，4-polybutadiene.In one embodiment, diene polymer is isoprene, comprises isoprene copolymer and isoprene block copolymer, as poly-(styrene-b-isoprene).

In one embodiment, isoprene is styrene isoprene styrene block copolymer (SIS), as the Kraton1161K that can obtain from Kraton, Inc.But, multiple applicable isoprene can be used, the isoprene (that is, 2-methyl isophthalic acid, 3-butadiene) comprising the HT200 that can obtain from ApexMedical, the KratonR310 that can obtain from Kraton and can obtain from DupontElastomers.In disclosed theme, spendable neoprene grade comprises the HT501 that can obtain from ApexMedical, and the neoprene (that is, polychloroprene) that can obtain from DupontElastomers, comprise the NeopreneG that can obtain from DupontElastomers, W, T and A type.Other sacculus that can use according to disclosed theme and the example of conduit embodiments comprise United States Patent (USP) the 4th, 748, No. 982; 5th, 496, No. 346; 5th, 626, No. 600; 5th, 300, No. 085 and the 6th, 406, No. 457, and application sequence the 12/371st, No. 426; 11/539th, No. 944; With the 12/371st, No. 422, wherein each section document is incorporated herein with its entirety all by reference.

According to another aspect of disclosed theme, expansible elements is the sacculus with multilamellar configuration.Multilamellar configuration at least can comprise ground floor and the second layer of the wall thickness with combination.As herein embody, the unrestriced object for illustrating, ground floor is made up of first polymeric material with the first maximum blow-up ratio, and the second layer is made up of second polymeric material with the second maximum blow-up ratio being greater than the first maximum blow-up ratio.At least ground floor and the second layer limit the less compliance of monolayer that the first polymeric material of equaling to combine wall thickness than wall thickness makes.

The multilamellar sacculus of disclosed theme can integrally or partly be formed by the polymeric tubular layer jointly extruded, and provides the easy manufacture of sacculus and the foley's tube formed thus.Multilamellar sacculus is formed by conventional blow is molded usually, and wherein multilayer polymeric property management is radially expanded in sacculus mould.The multilamellar sacculus produced has the inflation shape of the inner surface corresponding to mould, and it has the diameter of the internal diameter approximating greatly sacculus mould, and this is commonly referred to the nominal operation diameter of sacculus.Nominal pressure is for being filled to the inflation pressure needed for nominal operation diameter by sacculus.According to disclosed theme, sacculus is in the very little amount (that is, non-compliance) of the expansion under pressure higher than nominal pressure.As a result, sacculus reduces the injury to patient vessel to greatest extent, and sacculus continues the larger uncontrolled amounts that expands under the inflation pressure of the increase higher than nominal value else if, then there will be injury.In one embodiment, the polymeric material of the ground floor of multilamellar sacculus and the polymeric material of the second layer are elastomer, and it has the flexural modulus lower than inelastic body usually.The elastomer polymer being applicable to the ground floor and/or the second layer forming multilamellar sacculus has the flexural modulus of about 40kpsi to about 110kpsi.Therefore, be different from non-elastomeric material as PET, the multilamellar non-compliance sacculus of disclosed theme can be formed by one or more elastomers of the sacculus flexibility providing improvement.

United States Patent (USP) the 7th, describe additional detail and the example of the multilamellar sacculus be applicable to used in disclosed theme in 828, No. 766, the content of this patent is incorporated into herein with its entirety.

In another embodiment, the proximal part of expansible elements can comprise the proximal sleeve of enhancing.Strengthen proximal sleeve and can contribute to the anti-puncture of expansible elements, e.g., if expansible elements by inflation and discharge repeatedly.The proximal sleeve strengthened also can protect expansible elements from outer tubular member, the effect comprising any enhanced portion (if providing) of outer tubular member.The distal side edge of the proximal sleeve strengthened can comprise radiopaque material, or has the impervious applicable density of permission radiation.The proximal sleeve strengthened also can prevent the loudspeaker effect of outer tubular member, and can reduce the kink stress along expansible elements.The proximal sleeve strengthened also can allow the folding layout refolding making expansible elements in outer tubular member.The compliance of sacculus it should be understood that the degree that the polymer wall of the sacculus when inflation exceedes the nominal diameter of sacculus stretches/expands.Compliance curve represents the sacculus external diameter with the increase inflation pressure change being unit with millimeter/atmospheric pressure (mm/atm), so that steeper curve or curve section are pointed out higher than the compliance compared with horizontal curve.Term " non-compliance " it should be understood that to have and is not more than about 0.03mm/atm and the sacculus being not more than the compliance of about 0.025mm/atm in one embodiment.By contrast, compliant balloon has the compliance being greater than about 0.045mm/atm usually.For the sacculus of the diameter of 3.0mm, the non-compliance sacculus of disclosed theme has the compliance higher than the nominal value at about 0.01mm/atm to about 0.02mm/atm substantially.The compliance of sacculus is usually than having similar wall thickness but the compliance of 100% sacculus be made up of first (such as, maximum hardness) material is low by about 25% to about 50%.

As mentioned above and according to institute's main topic of discussion, adjustable foley's tube allows conveying beneficial agent or treatment preparation in bodily lumen (such as, cardiovascular or peripheral system).Particularly, adjustable foley's tube herein comprises beneficial agent releasing structure, for when outer tubular member moves the exposed length exposing or carry expansible elements relative to inner tubular element from its releasing beneficial agent.By this way, outer tubular member can protect this treatment preparation during conduit is transported to selection part.In addition, the exposed length according to expansible elements is determined by amount and the position of the medicine discharged.Such as and as described in reference to each embodiment herein, beneficial agent releasing structure can be the fluid form utilizing one or more orifice structure, or as the coating be arranged on the outer surface of expansible elements or reservoir.In addition, expansible elements can have following shape, and the active length that this shape is used for when being in inflation structure along expansible elements carries compartment at least partially, and wherein beneficial agent is communicated with this compartment.With reference to the various embodiments according to the adjustable foley's tube of the described theme of unrestricted object for description.

Such as, Fig. 9 shows the far-end of the adjustable foley's tube of the beneficial agent for carrying liquid form.As shown in Figure 9, the distal portions and having that expansible elements 140 is coupled to inner tubular element 110 is limited to room 35 in being communicated with inflation lumen 130 fluid wherein.As mentioned above, expansible elements 140 can conversion between discharge configuration and inflation structure.Outer tubular member 120 is positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements 140.The embodiment of Fig. 9 describes expansible elements 140, and it is in inflation structure and wherein exposed length is limited by the contraction of outer tubular member 120, for description object.

Expansible elements 140 also comprises the outer surface along its active length, and it has at least one orifice structure 141 be communicated with interior room 35 fluid be limited to wherein.Fluid from inflation lumen 130 enters in expansible elements 140 in room 35, is expanded to inflation structure to make expansible elements 140.At least one orifice structure 141 be configured to when expansible elements 140 be in inflation structure and outer tubular member 120 proximad shrink with exposed hole mouth structure 141 at least partially time allow fluid leave from it.In addition or alternatively, orifice structure 141 can be configured to open when expansible elements 140 is in inflation structure.In this embodiment, fluid can comprise useful or medicine or preparation.Therefore, beneficial agent source can be arranged to be communicated with inflation lumen 130 fluid.

Figure 10 shows another embodiment of the far-end of the adjustable foley's tube for carrying beneficial agent.In this embodiment, separation of the fluid inner chamber and room are configured to and inflation fluid delivering therapeutic preparation separately.Coaxially arranged such as and with reference to as conduit axle shown in the sectional view of Figure 11 A, inner tubular element 110 at least can comprise inflation lumen 130 and fluid lumen 132.In this embodiment, inner tubular element 110 comprises the first inner tubular element 110 ' and the second inner tubular element 110 ' that are arranged on wherein '.Therefore, second inner tubular element 110 ' ' limit inflation lumen 130, first inner tubular element 110 ' and the second inner tubular element 110 ' ' between annular space limit fluid lumen 132, wherein each inner chamber at least extends along the distal portions of inner tubular element 110.Figure 11 A is the sectional view of the inner tubular element 110 of Figure 10 that 11-11 along the line intercepts.Only for the purpose of description, outer tubular member 120 and expansible elements 140 are not shown in Figure 11 A.As described herein, inflation lumen 130 can be configured to receive wire wherein similarly, wherein provides sealing member distally to carry out fluid flowing to prevent inflation fluid.Alternatively, inner tubular element 110 also can comprise guide wire lumen 150, and its at least distal portions along inner tubular element 110 extends.With reference to figure 11A, guide wire lumen 150 can be positioned in inflation lumen 130 circlewise, and wherein inflation lumen 130 is positioned in fluid lumen 132 circlewise.As mentioned above, guide wire lumen 150 allows conduit 100 to carry on wire, and inflation lumen 130 limits the path that fluid is advanced along inner tubular element 110, to come inflation and discharge expansible elements 140 via interior room 35.Except inflation lumen 130 and guide wire lumen 150, provide fluid lumen 132 to limit the path or pipeline that are separated, to advance along inner tubular element 110 for the fluid of such as beneficial agent and leave expansible elements 140.

As the coaxially arranged alternative of conduit axle, Figure 11 B shows the alternative in the cross section of the inner tubular element 110 that 11-11 along the line intercepts, and wherein conduit axle is the monomer structure with many cavity arrangements, is similar to Fig. 3.Only for the purpose of description, not shown outer tubular member 120 and expansible elements 140 in Figure 11 B.Such as but non-for restriction, inner tubular element 110 can be the single component with the inflation lumen 130, fluid lumen 132 and the guide wire lumen 150 that are limited to wherein.Therefore, as described in, guide wire lumen 150, fluid lumen 132 and inflation lumen 130 extend in parallel with each other and/or neighboringly.

Refer again to Figure 10, the expansible elements 140 of this embodiment also can comprise inner membrance 140A and adventitia 140B.Inner membrance 140A and adventitia 140B can along the extension at least partially of the longitudinal length of conduit.As described in, inner membrance 140A and adventitia 140B is limited to fluid chamber 135 therebetween, and wherein fluid chamber 135 is communicated with fluid lumen 132 fluid, enters into fluid chamber 135 to allow the fluid from fluid lumen 132.Adventitia 140B can comprise at least one orifice structure 141 be limited to wherein.Orifice structure 141 be configured to when expansible elements 140 be in inflation structure and outer tubular member 120 proximad be contracted to orifice structure 141 at least partially time allow fluid leave from it.Such as, aperture can be configured to close when expansible elements is in discharge configuration or sealing, then stretches when being in inflation structure to open.

Orifice structure 141 can comprise the multiple apertures in the outer surface being limited to adventitia 140B.Each aperture can with fluid lumen directly fluid to be communicated with and/or fluid is communicated with independently, or can via fluid chamber 135(if any) fluid communication with each other.Such as, in the embodiment in figure 10, orifice structure 141 comprises aperture 141A-141H.Multiple aperture can have any suitable shape and size, and can provide the aperture of any desired amt.In one embodiment, multiple aperture is roughly the same dimensionally.In another embodiment, multiple aperture is different dimensionally, makes the aperture of large-size will discharge more substantial fluid or preparation from it substantially.The pattern along expansible elements 140 can be arranged in multiple aperture.This pattern can be uniform along the active length of expansible elements 140, or alternatively uneven, to provide the gradient of change as required.

As discussed further below, also labelling can be comprised according to the conduit of this theme.Such as, as shown in Figure 10, inner tubular element 110 can be included in the radiopaque labelling 63 of far-end of its distal portions nearside.Inner tubular element 110 also can comprise distally labelling 63 proximad at least one proximal marker 75 isolated.Figure 10 shows the multiple proximal marker 75 along inner tubular element 110 and the spaced apart preset distance of active length along expansible elements 140.Multiple aperture can have the pattern relevant to multiple proximal marker.Such as in the embodiment in figure 10, aperture 141A and 141E, 141B and 141F, 141C and 141G and 141D and 141H is often organized relevant to corresponding radiopaque labelling 75 along the length of inner tubular element 110.Thus, for being selected by means of relative to inner tubular element adjustment outer tubular member from the expectation aperture of its delivery formulations or position.

Further according to the another aspect of disclosed theme, the outer surface of expansible elements can limit compartment at least partially when being in inflation structure.Such as and unrestricted object, Figure 12 shows another embodiment of the far-end of adjustable foley's tube.The outer surface of expansible elements 140 can limit at least one compartment of the active length along expansible elements when being in inflation structure.That is, the unrestricted object for description, the outer surface of expansible elements 140 is being in the fixed compartment C along the active length of expansible elements 140 of inflation duration of structural deformation ₁at least partially.Figure 12 shows the compartment C of the exposed portion of the active length along expansible elements 140 ₁, C ₂and C ₃.If required, by optionally shrinking external part, the compartment of the selection quantity of expansible elements can keep being contained in outer tubular member 120 similarly.Therefore, outer tubular member 120 can determine the compartment quantity exposed for the active length of expansible elements 140 along the contraction of proximal direction.As shown in figure 12, orifice structure 141 comprises and at least one compartment C ₃at least one aperture 141J that fluid is communicated with.In other embodiments, port organization 141 can comprise the multiple apertures be communicated with at least one compartment fluid.In this way, can be introduced in compartment when treatment preparation is in the tissue T of balloon inflation to blood vessel wall.

Expansible elements 140 can comprise any suitable shape, to provide the compartment of separation as required.For describing and the object of example, as shown in figure 12, the outer surface of the exposed length of expansible elements 140 has the approximate sinusoidal shape of the longitudinal axis along conduit in inflation constructs.Alternatively, the compartment of separation can be assigned to limit by the cylinder or tapered portion with difference or diameter change.

According to another embodiment, multiple expansible elements that the compartment of separation can be longitudinally-spaced by the distal portions along inner tubular element limit.Particularly, Figure 13 illustrates the embodiment of the far-end of adjustable foley's tube with partial cross section, and it has multiple expansible elements 140,140C, 140D, 140E.In this embodiment, at least the second expansible elements 140C is connected on the distal portions of close first expansible elements 140 of inner tubular element 110.Second expansible elements 140C also comprises and is limited to room 35C in be communicated with inflation lumen 130 fluid via inflation port 601 wherein.Second expansible elements 140C has restriction compartment C ₁the outer surface of a part, and limit compartment C ₂another part.Therefore, each expansible elements can limit a more than compartment.Each compartment can comprise the orifice structure 602 with at least one aperture, and described aperture is communicated with corresponding compartment and fluid lumen 132 fluid.In other embodiments, orifice structure can comprise the multiple apertures be communicated with at least one compartment fluid.

Multiple expansible elements can have various suitable shape independently or together.As shown in figure 13, multiple expansible elements 140,140C, 140D, 140E have sinusoidal shape with gathering when inflation.As mentioned above, when described expansible elements is against the tissue T inflation of blood vessel wall, treatment preparation can be introduced in the compartment limited by described multiple expansible elements.

As mentioned above, beneficial agent releasing structure is not limited to orifice structure, but can comprise other embodiments as required.Such as and according to another embodiment as shown in figure 14, the outer surface of expansible elements 140 can have relative with compartment C ₄the beneficial agent releasing structure be communicated with.Beneficial agent releasing structure can comprise the close compartment C being arranged on expansible elements 140 ₄outer surface on beneficial agent coating 182.Alternatively or in addition, beneficial agent releasing structure can comprise at least one the reservoir (not shown) in the outer surface being limited at expansible elements 140, to keep compartment C ₄neighbouring treatment preparation.In addition or alternatively, beneficial agent delivery formulations can be arranged on and compartment C ₄microcapsule on the surface be communicated with or spherical form.

As mentioned above and as shown in figure 14, the inner tubular element of adjustable conduit as herein described also can comprise the fluid lumen 132 be limited at wherein, and it extends to the distal portions of inner tubular element 110 from the proximal part of inner tubular element 110.Fluid lumen 132 is via orifice structure 602 and compartment C ₄fluid is communicated with.

As shown in figure 14, when expansible elements 140 is in inflation situation and outer tubular member 120 proximad shrink to expose compartment C ₄time, beneficial agent can be introduced into by fluid lumen 132 tap hole mouth structure 602 and enter into compartment C ₄in.As described in, expansible elements 140 under inflation situation against the tissue T of blood vessel wall.Beneficial agent S source can be communicated with for introducing beneficial agent wherein with fluid lumen fluid.In addition, therefore to be controlled by the fluid stream in fluid lumen and/or expansible elements against the pressure of vascular tissue by adjustment in compartment.Therefore, can to increase, reduce and/or vibrate as required in compartment and therefore against the pressure of blood vessel wall, to take in the medicine controlling or be strengthened in blood vessel wall and tissue.In addition, inflation situation is in and outer tubular member 120 proximad is contracted at least one compartment C at expansible elements 140 ₄when, the vacuum source V be communicated with fluid lumen 132 fluid can extract compartment C ₄in negative pressure.This negative pressure can adjust the pressure in compartment similarly, and/or compartment C is stayed in extraction ₄in beneficial agent S and other materials.

With the previous embodiments of Fig. 9 and Figure 10, the orifice structure 602 of Figure 14 can comprise the multiple apertures in the outer surface being limited to expansible elements 140.Described multiple aperture can be configured to the pattern along expansible elements, and can be along the active length of expansible elements uniform pattern or can be non-uniform patterns.Respective apertures in multiple aperture can have suitable dimension.Aperture can be roughly similar dimensionally, or can be different dimensionally.Inner tubular element also can comprise the radiopaque distal marker 63 near distal portions, it can be used as the stop part in fluid lumen 132, and inner tubular element also can comprise distally labelling proximad at least one proximal marker 75 isolated, it can the position of limiting hole mouth structure 602.

Treatment preparation can be any suitable medicine or preparation, such as, be used for the treatment of medicine or the preparation of disease.The example of suitable beneficial agent or treatment preparation comprises any suitable medicine or preparation, such as anti-malignant cell proliferation agent, antiinflammatory, antitumor agent, anti-platelet agents, anticoagulant, antifibrin, antithrombus formation, resisting mitosis, antibiotic, anti-allergic agent or anti-oxidant compounds.This type for the treatment of preparation can be and be not limited to inorganic compound or organic compound, protein, peptide, polysaccharide and other sugar, lipoid, DNA and RND nucleotide sequence, antisense oligonucleotide, antibody, receptors ligand, enzyme, bonding peptide, the clot preparation comprising streptokinase and tissue plasminogen activation factor, antigen, hormone, growth factor, ribosome enzyme and the retrovirus vector of synthesis.

Such as, beneficial agent or treatment preparation can comprise cytostatic medicament.Term as used herein " cytostatics " is meant to slow down cell proliferation but allows the medicine of cell migration.The unrestriced object for illustrating, these cytostatic medicaments comprise macrolide antibiotic, rapamycin, everolimus, Zo Ta Mosi, biolimus, sirolimus, deforolimus, novolimus, myolimus, the structural derivative of rapamycin and functional analogue, the structural derivative of everolimus and functional analogue, the structural derivative of Zo Ta Mosi and functional analogue, and any macrocyclic lactone immunosuppressive drug.As herein speed the term " cytotoxin " that uses be meant to for cytostatic medicine, as chemotherapeutic agent.Some limiting examples of cytotoxic drugs comprise vincristine, D actinomycin D, cisplatin, taxane, paclitaxel and protaxel.Other medicines comprise dexamethasone, statin, sirolimus and tacrolimus.

Except beneficial agent or treatment preparation, any fluid composition in multiple fluid composition all can be applicable to expansible elements or is transferred from it.Fluid can comprise compound or additive, as polymer, binding agent, plasticizer, solvent, surfactant, additive, chelating agen, filler, excipient etc., or their combination.Be applicable to excipient, binding agent and other composition comprise U.S. Patent Application Serial the 12/636th, in No. 079 describe in detail those, this application is incorporated herein with its entirety by reference.In one embodiment, excipient comprises the poloxamer triblock copolymer of PEG (PEG), polyvinylpyrrolidone (PVP), polyethylene glycol oxide list oleic acid sorbitan ester (Tweens), poly-(oxirane)-poly-(expoxy propane)-poly-(oxirane) (pluoronics), carboxymethyl cellulose (CMC) and PEG phospholipid, as 1,2-distearolyl-sn-glyceryl-3-phosphoethanolamine-N-(methoxy (Polyethylene Glycol))-2000) (PEG-PE).In one embodiment, plasticizer comprises PEG, propylene glycol, N-Methyl pyrrolidone (NMP), glycerol and Tweens.The example of possible compound comprises Zo Ta Mositamosi, PVP and glycerol.In one embodiment, beneficial agent or treatment preparation can provide in liquid form or be dissolved in applicable solvent.In another embodiment, treatment preparation be provided as granule, and be mixed in applicable carrier be used as fluid application.

Such as the fluid composition of beneficial agent or treatment preparation can use multiple known technology to be applied to expandable parts, as, spraying (air atomizing, ultrasound wave, electrostatic, piezoelectricity etc.), spraying dry, pneumatic spraying, with pattern spraying, electrostatic spinning, draw send the application of fluid, dip-coating, spin coating, pipet coating, syringe coating, vapour deposition, print roll coating, microdroplet are coated with, ultrasonic atomization or alternate manner known to the skilled herein.On at least one measured length that coating can be applied to expansible elements or on the whole.Unrestriced mode by way of example, authorizes No. the 6th, 669,980, the United States Patent (USP) of Hansen; Authorize No. the 7th, 241,344, the United States Patent (USP) of Worsham; Authorize No. 2004/0234748th, the U.S. Publication of Stenzel; And U.S. Patent Application Serial the 61/345th, in No. 575, describe some coating process that can use in conjunction with disclosure theme, whole disclosures of these documents are incorporated herein by reference.According to the embodiment of disclosed theme, coating can be applied on the sacculus of folding sacculus or inflation.In addition, coating can directly be applied in the folding part of folding sacculus.The feature of coating can by process variables influence.Such as, for dipping process, the quality of coating and thickness can change with the impact of variable, e.g., immerse number of times, speed and the degree of depth and drying time and temperature.

According to another aspect of disclosed theme, expansible elements can be included in the microcapsule on its outer surface.In this regard, microcapsule structure becomes in order to surround coating and/or treatment preparation.Expansible elements, when inflation, is positioned at the tissue of the microcapsule contact arterial wall on the surface of expansible elements.As alternative, microcapsule can be formed in the wall on expansible elements surface, or is formed on tissue engagement portion part.Fracture by microcapsule and/or be diffused into arterial wall to come from microcapsule release coat and/or treatment preparation from microcapsule.Microcapsule can manufacture according to authorizing method disclosed in No. the 5th, 102,402, the United States Patent (USP) of Dror or the United States Patent (USP) the 6th, 129,705 authorizing Grantz and the patent wherein quoted, and each patent is incorporated into herein with its entirety by reference.

According to the another aspect of disclosed theme, inner tubular element and/or outer tubular member all can comprise distal tip structure.

According to another aspect of the theme disclosed in reference Figure 15 and Figure 16, the unrestriced object for illustrating, be depicted as the delivery configuration being in outer tubular member and extending completely according to the embodiment of the foley's tube of disclosed theme respectively, and be in its expanded configuration of outer tubular member contraction.The far-end 123 of outer tubular member and the distal tip 61 of inner tubular element comprise labelling respectively.As described further herein, the distal tip 61 of inner tubular element can comprise radiopaque labelling 63, to improve the visibility of distal tip in patient's vascular system.Distance between the labelling of the inner tubular element when outer tubular member is shunk and the labelling of outer tubular member points out the active length of the sacculus exposed.

As alternative or in addition, as discussed further herein, scale or labelling can be arranged on conduit near-end on to contribute to length adjustment and drug conveying.Distal tip can be made up of the soft polymetric material comprised as the tungsten of labelling.Soft tip can prevent the destruction to blood vessel wall when conduit is positioned at the vascular system of patient.

In addition, the unrestriced object for illustrating, Figure 17 depicts the expansible elements being in discharge configuration, and wherein outer tubular member extends completely.In this embodiment, outer tubular member does not comprise tip, and outer tubular member does not comprise the labelling of far-end.In this embodiment, the distal tip size of inner tubular element is defined as in order to engage against outer tubular member, and prevents outer tubular member excessively extension distad.Figure 18 depicts the expansible elements being in inflation structure, and wherein outer tubular member is shunk.As shown in the figure, distal tip also can provide sealing member to be exposed to blood samples of patients to prevent or to reduce expansible elements and treat preparation, until conduit is in treatment place and outer tubular member contraction.Distal tip as embodied herein additionally provides the more level and smooth transition between the near-end of tip and the far-end of outer tubular member.In another embodiment, distal tip is formed by making the far-end of inner tubular element become circle.

In another embodiment, outer tubular member is included in the distal tip of its far-end.Figure 19 A depicts the distal tip 71 of the outer tubular member of the metal marker 73 had on the far-end of outer tubular member 120.In this embodiment, inner tubular element 110 is not included in the tip of its far-end.Figure 19 B depicts the distal tip 71 of outer tubular member, and wherein the far-end of outer tubular member comprises the markd soft tip of tool.As described above, a kind of method realizing shown structure is by using the polymer loading tungsten.In other embodiment of disclosed theme, inner tubular element and outer tubular member can comprise distal tip respectively.Figure 19 C depicts the distal tip 61 of inner tubular element and the distal tip 71 of outer tubular member, and they both can comprise labelling, and can be soft at its corresponding far-end.As discussed in the previous article, the tip of inner tubular element and the tip of outer tubular member can contribute to rigidity or the flexibility of conduit.

According to an aspect of disclosed theme, adjustable foley's tube 100 can comprise multiple radiopaque labelling.Labelling can be placed in the multiple applicable position along conduit, includes but not limited to, inner tubular element, outer tubular member and expansible elements.

Referring to Figure 20, the unrestriced object for illustrating, Figure 20 depicts the embodiment of the far-end of adjustable foley's tube.Figure 20 depicts the multiple labellings distributed along length-adjustable conduit.The distal tip 61 of inner tubular element comprises radiopaque labelling 63.In addition, as shown in the figure, inner tubular element is included at least one proximal marker of the nearside of distal marker.In the embodiment of Figure 20, radiopaque labelling is from the far-end of inner tubular element along length towards its proximal extension.Labelling 75 can extend in expansible elements along a part for inner tubular element.At least one proximal marker can be positioned to the center of the active length of contiguous expansible elements.Labelling can proceed to the near-end of inner tubular element, comprises the labelling (if providing) in hypotube.In this embodiment, outer tubular member is included in the labelling 73 of its far-end.Labelling 73 can be positioned on the tip place of outer tubular member, or independent of any tip at outer tubular member place.Comprise in the embodiment of coil configuration at inner tubular element, radiopaque labelling can be provided with coil configuration, or can being made up of radiopaque material at least partially of coil configuration.In this embodiment, labelling can be the independent radiopaque parts be attached on parts, or applies by any applicable method known in the such as industry, includes but not limited to, gas-phase deposition.

In one embodiment, radiopaquely preset distance that strategy is spaced apart from each other is marked at, to measure the active length of expansible elements.Labelling is spaced apart from each other with known increment, the position of the exact length determining the expansible elements exposed to allow doctor and the other parts of determining conduit.Such as, each radiopaque labelling can along the spaced apart about 10mm of a part for inner tubular element.In addition or as alternative, gradient or the similar marking can be located on the near-end of adjustable foley's tube, to identify the distance that outer tubular member has been shunk, and the exposed length of expansible elements is therefore identified.

Expansible elements also can comprise labelling.Labelling can be positioned on multiple applicable position, includes but not limited to the far-end of expansible elements and the near-end of expansible elements.In one embodiment, as shown in Figure 21, when inflation, radiopaque labelling 145 is applied to the outside of expansible elements, and wherein pattern limits length, diameter or further feature.In this embodiment, labelling applies by known vapour deposition in the such as industry.

Labelling can comprise any applicable material.Such as, labelling can be made up of the polymer filling or pour into radiopaque material, and also can include but not limited to PPS, tungsten and fiberglass combination; PA12 and ceramic combination; PEEK and ceramic combination; And PBT and ceramic combination.

Be appreciated that disclosed theme comprises configuration medical treatment device and provides the method for adjustable sacculus from description above.The method comprises the adjustable foley's tube providing any combination comprising feature as previously described.The method also comprises to be inserted conduit in the bodily lumen of patient, and makes outer tubular member shrink the exposed length of the active length to limit expansible elements along proximal direction.Shrink the exposed length that also can comprise and select expansible elements, the external diameter of expansible elements is determined selectively by outer tubular member.The exposed length of expansible elements is inflated to inflation structure, as by being introduced in inflation lumen by fluid.Expansible elements is disposed to discharge configuration, and takes out from the bodily lumen of patient.

Therefore, doctor can expose required sacculus many like that selectively, to perform desired treatment.Therefore, according to disclosed theme, the unrestriced object for diagram, doctor by expose selectively above-mentioned desired by length, use the expansible elements of a length or sacculus to treat the vessel section of variable-length.Clearly, and they are described in detail together with the various features of device for the additional aspect of the method performed as disclosed use conduit and advantage.

According to the another aspect of disclosed theme, provide a kind of method of carrying beneficial agent.The method comprises the adjustable foley's tube providing any embodiment as herein described.In a specific embodiment and refer again to Figure 14, adjustable foley's tube comprises inner tubular element 110, and it has proximal part, distal portions and length betwixt.Inner tubular element 110 also comprises the inflation lumen 130 and fluid lumen 132 that are limited to wherein.Expansible elements 140 is coupled to the distal portions of inner tubular element 110, and has and be limited to room 35 in being communicated with inflation lumen 130 fluid wherein.Expansible elements 140 can conversion between discharge configuration and inflation structure.

As shown in figure 14, expansible elements 140 also has the outer surface along its active length, and this outer surface limits the compartment C when being in inflation structure along the active length of expansible elements ₄at least partially.Described outer surface also has relative with at least one compartment C ₄the beneficial agent releasing structure be communicated with.Outer tubular member 120 can move relative to inner tubular element 110, and outer tubular member 120 comprises far-end.Outer tubular member 120 can move at the extended position be arranged on expansible elements 140 and between the punctured position of extended position nearside, this outer tubular member 120 can be positioned between extended position and punctured position selectively, to limit the exposed length of the active length of expansible elements 140.

The method also comprises: make outer tubular member 120 shrink the exposed length of the active length to limit expansible elements 140 along proximal direction, and makes the exposed length of expansible elements 140 be inflated to inflation structure.Beneficial agent is released to form reservoir from least one orifice structure, and expansible elements 140 is disposed to discharge configuration.

Alternatively, according to the another aspect of disclosed theme, provide and use another one in adjustable foley's tube as herein described to transmit the method for beneficial agent.Such as, the method can comprise provides adjustable foley's tube, and this adjustable foley's tube comprises inner tubular element, and it has proximal part, distal portions and length betwixt.Inner tubular element also can have the inflation lumen and fluid lumen that are limited to wherein.Expansible elements is coupled to the distal portions of inner tubular element, and has and be limited to room in being communicated with inflation lumen fluid wherein, and expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has the outer surface along its active length, and this outer surface has at least one orifice structure be communicated with fluid lumen fluid be limited to wherein.Outer tubular member can move relative to inner tubular element, and outer tubular member comprises far-end, and outer tubular member can move at the extended position be arranged on expansible elements and between the punctured position of extended position nearside.Outer tubular member is positioned between extended position and punctured position selectively to limit the exposed length of the active length of expansible elements.The method also comprises: make outer tubular member shrink the exposed length of the active length to limit expansible elements along proximal direction, and makes the exposed length of expansible elements be inflated to inflation structure.The method also comprises: from least one orifice structure releasing beneficial agent, and expansible elements is disposed to discharge configuration.

Further according to the another aspect of disclosed theme, provide the method using one of adjustable foley's tube as herein described to carry beneficial agent.Such as, the method can comprise provides adjustable foley's tube, and it comprises inner tubular element, and this inner tubular element has proximal part, distal portions and length betwixt, and this inner tubular element also has the inflation lumen and fluid lumen that are limited to wherein.Expansible elements is coupled to the distal portions of inner tubular element, and has and be limited to room in being communicated with inflation lumen fluid wherein, and expansible elements can conversion between discharge configuration and inflation structure.Expansible elements also has the outer surface along its active length, when being in inflation structure along the compartment of the active length of expansible elements at least partially, this outer surface also has the relative beneficial agent releasing structure be communicated with at least one compartment to the restriction of this outer surface.Outer tubular member can move relative to inner tubular element, this outer tubular member comprises far-end, this outer tubular member can move between the extended position be arranged on expansible elements and the punctured position of extended position nearside, and this outer tubular member is positioned between extended position and punctured position selectively to limit the exposed length of the active length of expansible elements.The method also comprises: make outer tubular member shrink the exposed length of the active length to limit expansible elements along proximal direction, and utilizes the compartment along exposed length to make the exposed length of expansible elements be inflated to inflation structure.Beneficial agent is released to compartment from beneficial agent releasing structure, and expansible elements is disposed to discharge configuration.

Although describe disclosed theme according to some embodiment herein, person of skill in the art will appreciate that and can carry out various changes and improvements when not departing from its scope to disclosed theme.In addition, although the independent characteristic of disclosed theme embodiment can be discussed in this article or do not illustrate in other embodiments shown in the figure of an embodiment, but it should be understood that an embodiment independent characteristic can with one or more characteristics combination of another embodiment or the characteristics combination with multiple embodiment.

Except the various embodiments drawn and propose, disclosed theme is also for having the dependent claims that hereafter proposes and those other embodiment of other possible combination any above-disclosed.Therefore, what exist in dependent claims can, with the mode of the scope of disclosed theme and combination with one another, make disclosed theme should be recognized as also special other embodiment for having other possible combination any with above-disclosed specific embodiment.Therefore, the above description of the specific embodiment of disclosed theme is proposed for the object illustrated and describe.Itself and not intended to be are be intended to disclosed theme to be limited to those disclosed embodiments thoroughly or not.

Many remodeling of specific embodiment mentioned above, modification or other equivalent will be apparent for those skilled in the art.It is desirable that, the scope of disclosed theme is by following claim and be familiar with the apparent remodeling of dealer of this area, modification and equivalents.Therefore, expect that disclosed theme is included in remodeling in the scope of claims and equivalent thereof and modification.

Claims

1. an adjustable foley's tube, comprising:

Inner tubular element, described inner tubular element has proximal part, distal portions and length betwixt, and described inner tubular element also has the inflation lumen and fluid lumen that are limited to wherein;

Expansible elements, the distal portions and having that described expansible elements is coupled to described inner tubular element is limited to room in being communicated with described inflation lumen fluid wherein, described expansible elements can be changed between discharge configuration and inflation structure, described expansible elements also has the outer surface along its active length, and described outer surface has at least one orifice structure be communicated with described fluid lumen fluid be limited to wherein; And

Outer tubular member, described outer tubular member can be moved relative to described inner tubular element, described outer tubular member comprises far-end, described outer tubular member can move at the extended position be arranged on described expansible elements and between the punctured position of described extended position nearside, and described outer tubular member is positioned between described extended position and described punctured position selectively to limit the exposed length of the active length of described expansible elements.

2. the adjustable foley's tube according to aforementioned claim, also comprise the fluid chamber between inner membrance and adventitia being limited at described expansible elements, described fluid chamber is communicated with described fluid lumen fluid, and described adventitia has at least one orifice structure be limited to wherein.

3. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described orifice structure be configured to when described expansible elements be in inflation structure and described outer tubular member proximad be contracted to described orifice structure at least partially time allow fluid leave from it.

4., according to adjustable foley's tube in any one of the preceding claims wherein, also comprise the beneficial agent source be communicated with described fluid lumen fluid.

5. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described orifice structure comprises the multiple apertures in the outer surface being limited at described expansible elements.

6. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described multiple aperture is configured to the pattern along described expansible elements.

7. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described pattern is uniform along the active length of described expansible elements.

8. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described multiple aperture is roughly similar dimensionally.

9. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described multiple aperture is different dimensionally.

10. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described inner tubular element is included in the radiopaque distal marker of described distal portions nearside.

11. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described inner tubular element also comprises from described distal marker proximad at least one proximal marker isolated.

12. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, multiple proximal marker is along active length spaced apart preset distance on described inner tubular element of described expansible elements.

13. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described orifice structure comprises the multiple apertures limited by the outer surface of described expansible elements, and described multiple aperture has the pattern relevant to described multiple proximal marker.

14. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, the outer surface of described expansible elements to limit when being in described inflation and constructing along the compartment of the active length of described expansible elements at least partially.

15. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described orifice structure comprises at least one aperture be communicated with at least one compartment fluid described.

16. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described expansible elements has when described expansible elements is in described inflation structure around the roughly helix of the longitudinal axis of described conduit or spiral shape.

17. according to adjustable foley's tube in any one of the preceding claims wherein, also comprise at least the second expansible elements on the distal portions of close described first expansible elements being coupled to described inner tubular element, described second expansible elements has and is limited to room in being communicated with described inflation lumen fluid wherein, and described second expansible elements also has the outer surface of the another part limiting compartment.

18. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, the outer surface of described expansible elements is limited to the isolated multiple compartment of active length along described expansible elements when being in described inflation structure.

19. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, the longitudinal axis of outer surface when being in described inflation structure along described conduit of the exposed length of described expansible elements has approximate sinusoidal shape.

20. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described inner tubular element also has the guide wire lumen be limited to wherein, and described guide wire lumen extends along at least distal portions of described inner tubular element.

21. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described guide wire lumen, described fluid lumen and described inflation lumen are in coaxial configuration.

22. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described guide wire lumen, described fluid lumen and described inflation lumen extend parallel to each other.

23. 1 kinds of adjustable foley's tubes, comprising:

Inner tubular element, described inner tubular element has proximal part, distal portions and length betwixt, and described inner tubular element also has the inflation lumen be limited to wherein;

Expansible elements, the distal portions and having that described expansible elements is coupled to described inner tubular element is limited to room in being communicated with described inflation lumen fluid wherein, described expansible elements can be changed between discharge configuration and inflation structure, described expansible elements also has the outer surface along its active length, described outer surface is being in the fixed compartment along the active length of described expansible elements of described inflation duration of structural deformation at least partially, and described outer surface also has the beneficial agent releasing structure that relative and described compartment is communicated with; And

24. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described beneficial agent releasing structure comprises the beneficial agent coating on the outer surface being arranged on described compartment nearside.

25. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described beneficial agent releasing structure comprises at least one reservoir limited by the outer surface of the expansible elements of described compartment nearside.

26. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described beneficial agent releasing structure comprises the orifice structure in the outer surface being limited at described expansible elements, and described orifice structure is communicated with described compartment fluid.

27. according to adjustable foley's tube in any one of the preceding claims wherein, wherein, described inner tubular element also has the fluid lumen be limited to wherein, described fluid lumen extends to distal portions from the described proximal part of described inner tubular element, and described orifice structure is communicated with described fluid lumen fluid.

28. according to adjustable foley's tube in any one of the preceding claims wherein, also comprise the beneficial agent source be communicated with described fluid lumen fluid, be in described inflation structure at described expansible elements and described outer tubular member proximad is contracted to described compartment time beneficial agent is introduced through described fluid lumen and flows out described orifice structure and enter into described compartment.

29. according to adjustable foley's tube in any one of the preceding claims wherein, also comprise vacuum source, its be communicated with to be in inflation situation when described expansible elements with described fluid lumen fluid and described outer tubular member proximad is contracted at least one compartment described time extract negative pressure in described compartment.

30. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described orifice structure comprises the multiple apertures in the outer surface being limited at described expansible elements.

31. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described multiple aperture is configured to the pattern along described expansible elements.

32. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described pattern is uniform along the active length of described expansible elements.

33. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described multiple aperture is roughly similar dimensionally.

34. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described multiple aperture is different dimensionally.

35. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described inner tubular element is included in the radiopaque distal marker of described distal portions nearside.

36. according to adjustable foley's tube in any one of the preceding claims wherein, and wherein, described inner tubular element also comprises from described distal marker proximad at least one proximal marker isolated.

37. 1 kinds of methods of carrying beneficial agent, described method comprises:

There is provided adjustable foley's tube, described adjustable foley's tube comprises:

Outer tubular member, described outer tubular member can be moved relative to described inner tubular element, described outer tubular member comprises far-end, described outer tubular member can move at the extended position be arranged on described expansible elements and between the punctured position of described extended position nearside, and described outer tubular member is positioned between described extended position and described punctured position selectively to limit the exposed length of the active length of described expansible elements; And

Described outer tubular member is made to shrink the exposed length of the active length to limit described expansible elements along proximal direction;

The exposed length of described expansible elements is made to be inflated to described inflation structure;

From at least one orifice structure releasing beneficial agent described; And

Described expansible elements is made to be disposed to described discharge configuration.

38. 1 kinds of methods of carrying beneficial agent, described method comprises:

Expansible elements, the distal portions and having that described expansible elements is coupled to described inner tubular element is limited to room in being communicated with described inflation lumen fluid wherein, described expansible elements can be changed between discharge configuration and inflation structure, described expansible elements also has the outer surface along its active length, described outer surface is when being in the fixed compartment along the active length of described expansible elements of described inflation duration of structural deformation at least partially, described outer surface also has the beneficial agent releasing structure that at least one compartment relative and described is communicated with, and

The compartment along described exposed length is utilized to make the exposed length of described expansible elements be inflated to described inflation structure;

Beneficial agent is discharged into described compartment from described beneficial agent releasing structure; And

39. methods according to aforementioned claim, also comprise: after releasing beneficial agent wherein, change the pressure in described compartment.