CN103599588B

CN103599588B - Improved balloon catheter exhibiting rapid inflation and deflation

Info

Publication number: CN103599588B
Application number: CN201310453105.8A
Authority: CN
Inventors: K·J·埃伦赖希; J·马加纳; P·孔希尼
Original assignee: Abbott Cardiovascular Systems Inc
Current assignee: Abbott Cardiovascular Systems Inc
Priority date: 2010-04-30
Filing date: 2011-04-29
Publication date: 2017-04-26
Anticipated expiration: 2031-04-29
Also published as: GB2505572B; GB2505572A; GB2505572A8; GB2493120A; GB2493120B; WO2011137372A9; CN102939126A; EP2563446A1; GB201219332D0; GB201315742D0; WO2011137372A1; CN102939126B; CN103599588A

Abstract

The invention relates to a catheter capable of rapid inflation and deflation and operable by one individual.

Description

Rapid expansion and the improved ball ductus bursae for shrinking is presented

It is 2011 that the application is entitled " the improved ball ductus bursae for rapid expansion being presented and shrinking ", international filing date The patent of invention Shen that April 29, international application no are PCT/US2011/034621, national applications number is 201180028064.7 Divisional application please.

Cross reference to related applications

The application is the continuous case in part of following co-pending U.S. Patent application：U.S. that on April 30th, 2010 submits to State Patent Application Serial No.12/771946；The U.S. Patent Application Serial No.12/771968 that on April 30th, 2010 submits to； The PCT/US2010/033270 that on April 30th, 2010 submits to；The PCT/US2010/033276 that on April 30th, 2010 submits to； The U.S. Patent Application Serial No.13/032733 for submitting to on 2 23rd, 2011；The United States Patent (USP) submitted to on 2 23rd, 2011 Application sequence No.13/032743, the content disclosed in each above-mentioned application is from there through being incorporated by this text.

Technical field

The present invention relates to a kind of improved ball ductus bursae, which is configured to make sacculus expand rapidly and shrink for blood Tuboplasty, post processing and other medical operatings.

Background technology

Angioplasty catheter is typically used in execution PCTA.Traditional angioplasty catheter it is known that and be modified or quilt It is configured to therapeutic preparation is partly delivered to the vascular system of destination object.However, to using angioplasty catheter institute Required preparation not only takes, and difficult.In order that the sacculus expansion on angioplasty catheter, not only needs the time accurate Standby sacculus and catheter body, and need two people to carry out operation device.The time lost using traditional angioplasty catheter Sometimes for the patient for needing medical operating can be life-and-death problem.It is then desired to a kind of foley's tube, which is main Can by rapidly use and can easily by operator's promptly management and control.

Disclosed theme is configured to make sacculus expand rapidly and shrink and easily by an operator by providing The conduit system that uses and solve above-mentioned needs.

The content of the invention

According to the one side of disclosed theme, there is provided a kind of improved catheter.The conduit of disclosed theme is in expansion In terms of time and contraction time and in delivering benefit agent（Such as medicine and other therapeutic agents）Aspect presents beyond tradition The improvement of foley's tube.The conduit of disclosed theme can also provide a kind of modified model for performing the uniqueness of post-processing technology Design.

In one embodiment, conduit includes：Sacculus, which is disposed near the distal end of conduit；And catheter shaft, its Limit expansion tube cavity and guidewire lumen.Expansion tube cavity provides fluid communication between inflation port and the inside of sacculus, and leads Fiber tube chamber is suitable to slidably receive the seal wire that proximally guidewire port extends to distal guidewire port.Catheter design can be less than Expand sacculus in the time of about four seconds.In certain embodiments, conduit can make sacculus swollen within the time of less than about one second It is swollen.In yet another embodiment, sacculus can be expanded within the time of half second.

In another embodiment, catheter shaft also includes shrinking tube chamber.Shrink tube chamber to separate with expansion tube cavity, and independently of The expansion tube cavity.Shrink tube chamber fluid communication is provided between constriction and the inside of sacculus.In one embodiment, sacculus Shrink and can occur within the time of less than about five seconds.In one embodiment, conduit can make sacculus so fast at one second Time contract.Catheter-balloon can expand and shrink up to repeatedly circulation.This is particularly useful to perform post-processing technology.

In certain embodiments, conduit can deliver benefit agent.Specifically, conduit may be adapted to include delivery tube Chamber, to deliver one or more benefit agent.In another embodiment, sacculus can include the coating with benefit agent. In one embodiment, benefit agent is contrast media.So, conduit compared with traditional angioplasty catheter using less Contrast media.For example, conduit uses few fortyfold contrast agent than angioplasty catheter.Benefit agent can also be medicine or Other therapeutic agents.In these cases, it has been found that conduit makes absorption of the tissue to benefit agent averagely improve at least 40 Times.Suitable benefit agent is included but is not limited to：Calpain inhibitor, pH stabilizers or endothelin receptor antagonists, Ramulus et folium taxi cuspidatae Alcohol, rapamycin or their analog or derivant.Benefit agent may be at such as PVP, glycerol or the tax of both In shape agent.

In certain embodiments, expansion tube cavity, shrinking tube chamber, guidewire lumen and delivering tube chamber can be with juxtaposition forming I-shaped Beam shape polymer web, the polymer web are laterally aligned with the longitudinal axis of tube chamber.I-beam configuration provides improved Intensity and less profile, to insert in blood vessel and through tortuous vascular system.

According to the inventive subject matter, disclose a kind of conduit for improving patient's heart function.The conduit includes：Sacculus, Which is disposed near the distal end of conduit；And catheter shaft, which limits expansion tube cavity and detached contraction tube chamber.Expansion tube Chamber and contraction tube chamber are there is provided the independent fluid communication between inflation port and retract port and the inside of sacculus.Send out Show conduit by the ejection fraction of destination object（ejection fraction）Bring up at least 30%.30% ejection fraction can be with It is maintained for more than 7 days, and is maintained for more than 28 days in certain embodiments.

According on the other hand, there is provided a kind of conduit system.The conduit system includes：It is disposed in the distal end of conduit Neighbouring sacculus, and fluid circuit.The fluid circuit includes：Contain the expansion reservoir of fluid, expansion tube cavity and detached Shrink tube chamber.Expansion tube cavity and contraction tube chamber provide independent fluid between inflation port and retract port and the inside of sacculus Connection.Control circuit also include irreversible loading attachment with allow expand fluid from reservoir stream to expansion tube cavity.In a reality Apply in example, loading attachment penetrates reservoir to allow expansion fluid is discharged in expansion tube cavity.Expansion fluid is preferably gaseous state Material.

In one embodiment, conduit includes indicator, to indicate that sacculus expands completely.Indicator is arranged sacculus and exists Between the check-valves being associated with contraction tube chamber.Thus, indicator is fool proof for sacculus expansion is indicated.

In certain embodiments, it has been found that conduit after destination object occurs ischemic events contributes to improving target The infarct size and/or risk area of object.

Description of the drawings

With reference to the following accompanying drawing being briefly described as follows there is provided the various aspects to subject matter described herein, feature and enforcement The detailed description of example.Accompanying drawing is schematic, it is not necessary in proportion describing, and some building blocks and feature are risen in order to clear See and be exaggerated.Accompanying drawing shows the various aspects and feature of present subject matter, and can illustrate this entirely or in part One or more embodiments of bright theme or example.

Figure 1A and Figure 1B are the schematic views of the exemplary post-processing technology according to disclosed theme；

Fig. 2 and Fig. 3 are the schematic views of the system of the one embodiment according to disclosed theme；

Fig. 4 A to Fig. 4 C are the principle schematic diagrams of the catheter shaft of the embodiment according to disclosed theme；

Fig. 5 is the figure table according to relevant doctor/operator's concern power of disclosed theme or the contrast of Automobile driving Diagram；

Fig. 6 show according to disclosed theme with regard to the figure to Bulking Time and the result of contraction time comparative study Table；

Fig. 7 A and Fig. 7 B are the viewgraph of cross-section of the catheter shaft of the one embodiment according to disclosed theme；

Fig. 8 A and Fig. 8 B are the perspective views of the embodiment of the sacculus according to disclosed theme；

Fig. 8 C and Fig. 8 D are the perspective views of another embodiment of the sacculus according to disclosed theme；

Fig. 8 E to Fig. 8 F are the perspective views of another embodiment of the sacculus according to disclosed theme, and Fig. 8 G are in figure The end-view of the embodiment of the sacculus of theme disclosed by the basis shown in 8E to Fig. 8 F；

Fig. 9 A and Fig. 9 B are the viewgraph of cross-section of some embodiments of the handle according to disclosed theme；

Fig. 9 C to Fig. 9 R are the perspective views of the various embodiments of the handle according to disclosed theme；

Figure 10 is the exploded view of the fluid circuit of the one embodiment according to disclosed theme；

Figure 11 A to Figure 11 C are the principle schematic diagrams of the pulse valve according to disclosed theme；

Figure 12 is the side view of the fluid circuit according to disclosed theme；

Figure 13 A to Figure 13 T are the perspective views of the exemplary building block of the fluid circuit of Figure 12；

Figure 14 A to Figure 14 C are block diagrams, show fluid circuit by the one embodiment according to disclosed theme Expansion flow of fluid；

Figure 15 A to Figure 15 N are the side views of some embodiments of the loading attachment according to disclosed theme；

Figure 16 is the figure expression figure of the contrast of the contrast agent adopted according to disclosed theme；

Figure 17 be according to disclosed theme, Reperfu- sion circulation in series of steps figure expression figure, its description Go out to balloon distal delivery of contrast agents；

Figure 18 is that the cooperating type mechanical type post processing of the one embodiment according to disclosed theme and local benefit agent are treated The principle schematic diagram of method；

Figure 19 is to illustrate the comparative study according to disclosed theme, tissue resorption to benefit agent in various tissues Result chart；

Figure 20 is the chart of the plasma concentration for illustrating benefit agent according to disclosed theme, after post-treatment；

Figure 21 is to illustrate according to disclosed theme, the figure of the contrast of infarct size and risk area ratio is represented Figure；With

Figure 22 is the figure expression figure of the contrast to ejection fraction according to disclosed theme.

Specific embodiment

I. conduit is summarized

According to this theme, conduit system is configured to allow for the expandable members of such as sacculus and very rapidly expands and receive Contracting, and especially allow the expandable members sequentially（For example interval and repeatedly）Expansion and contraction.In certain embodiments, The sequential inflation of sacculus and contraction are by one touch type（single-touch）Activate to realize.Term " one touch type " used herein Meaning allows expandable members expansion and the actuating shunk to come real by single switch, single button or other single points It is existing.Thus, user simply presses or activate actuator expands sacculus, and press the actuator again so that The contraction of dynamic sacculus.Thus, expand with generally requirement measurement size, preparation and by rotating the screw on dilation device Angioplasty catheter it is different, one embodiment of present system can make its in the case where preparing promptly Use.

Showing to this progressively, many steps of angioplasty balloon catheter requirements are measuring size, preparation, go degasification Bubble and use device, but the conduit system of the embodiment of system according to the invention is much effective, it is shorter so as to provide Operating time simultaneously reduces the risk of patient.Therefore, system as described herein causes post-processing step to reduce, and finally leads to Crossing saving for survival is the time of key factor and has saved life.

Rapid-exchange catheter is removed from patient body, introduces to deliver benefit agent by foley's tube on seal wire no Replaced to balloon distal and then again under the quick additional step for exchanging foley's tube, traditional rapid exchange angioplasty art Foley's tube does not have measure that the benefit agent of such as medicine is delivered to the balloon distal of foley's tube body.

In addition, though foley's tube can block blood flow and deliver substances into catheter body distal end on seal wire Distal end, but conduit embodied herein is provided the advantage that.The quick use for exchanging length wire rod is most common.The present invention's Conduit can be used in the case of switching seal wire not lost time.Switching seal wire（RX is switched to OTW）The consuming time.The present invention Pipe guide allow during seal wire stays in place by operator, and OTW catheter design needs doctor to change and may disturb Move the position of seal wire.Thus, even if benefit agent can be delivered to OTW conduits the distal end of catheter body, change seal wire Lost time.The conduit system of the present invention can extend on seal wire, and sacculus can be delivered to blood vessel in benefit agent Another other region while block blood vessel.In one embodiment, a kind of sacculus for being dimensioned for all sizes is allowed Benefit agent is delivered to operator the position of blood vessel.And, the situation for meeting balloon features with blood vessel is completely contradicted, sacculus symbol The ability of conjunction shape of blood vessel allows to make conduit once in the tube chamber of multiple sizes and in multiple positions.In other devices, If operator wants to deliver medicine or other compounds during angioplasty or post processing are performed the operation, he or she must not Do not obtain various sizes of angioplasty balloon benefit agent is delivered in the diverse location of blood vessel.On the contrary, herein Described conduit allows catheter movement to other positions.Thus, when conduit is used to deliver such as medicine or other therapeutic agents During benefit agent, compared with angioplasty balloon conduit on traditional quick exchange foley's tube or seal wire, reality described herein The advantage with regard to reducing using the step required for conduit and operative procedure quantity for applying example becomes obvious.Thus, when needs make When benefit agent being delivered to balloon distal with conduit, there is no time-saving advantage using rapid-exchange catheter.So far, doctor It is limited to save the seal wire of time advantage on foley's tube with rapid-exchange catheter identical using no.Therefore, present invention system System is provided and is quickly exchanged by the ability of catheter delivery therapeutic agent by while conduit is coupled with quick exchange guidewire The benefit of foley's tube on foley's tube and seal wire.

In traditional angioplasty technology, the size and diameter of sacculus must with wait to expand aortic blocking sections Size and native diameter match.If the size of sacculus and diameter are less than natural tremulous pulse, the result of balloon angioplasty It is less than optimal, need to carry out second expansion with larger sized sacculus.Cause operative failure in some cases and understand Need second individually angioplasty procedures program or replacement pipe operation（bypass surgery）.If sacculus relative to The blocking sections of native blood vessels is excessive, then the inwall of tremulous pulse can be cut open and completely plugged blood vessel from the remainder of tremulous pulse, caused Blood totally terminates to the flowing of myocardium target region.The complication can cause acute myocardial infarction and necessary urgent replacement pipe handss Art.If acute infarct causes bigger infraction, death may be caused.

If patient has single position of being obstructed in right coronary artery service system or left coronary artery system, will be to think The expansion surgical selection wanted has the single foley's tube of matching diameter and size.When sacculus is in natural artery or other blood vessels In blocking sections during expansion, sacculus should maintain initial pre-shaped configuration and diameter under maximum allowable pressure.It is single expanding During injury, although have and initially irrelevantly have selected foley's tube so that having to second foley's tube comes successfully complete Into the situation of operative procedure, but the foley's tube of suitable size is selected to be better simply.

However, in many angiopathys, foley's tube selects to become chaotic and complicated.For example, patient may be coronal on a left side In tremulous pulse have three injuries, these three injuries each can be close to successfully to realize balloon angioplasty. But these injuries are likely to be in the different blood vessel of size.By conventional balloon conduit in the different injury of size Middle execution angioplasty is not that federation is impossible, but this is not only troublesome but also poorly efficient.For each injury, matching Foley's tube is exchanged and is manipulated in target injury.For this purpose, three continuous operations substantially need the operative procedure of three times Time, the radiography dosage of three times, and the detached foley's tube of minimum of three and its auxiliary equipment.

According to the one side of described theme, there is provided a kind of more powerful and balloon catheter system more efficiently. In one embodiment, balloon catheter system is pre-assembled device, with a kind of sacculus for being dimensioned for all sizes, the ball Capsule is designed in various different blood vessels（Such as coronary vasodilator, peripheral blood vessel, spinal column blood vessel, cerebral blood vessel）Used in, from And the device that a kind of operator need not expand selection pressure or volume to sacculus is provided.Therefore, doctor need not lose time On additional step needed for sacculus sizing and preparation, and needed for the exactly traditional angioplasty balloon conduit of these steps Want.Thus, one embodiment of system provides a kind of mode for easily and efficiently using conduit, the conduit quilt for doctor It is designed so that sacculus promptly expands and shrinks, so as to be applied not only to for example reduce after ischemic events or prevent to device Official or the reperfusion injury of tissue（Such as post processing）, operator is additionally operable to typically using traditional angioplasty balloon conduit Other application occasion.

When the system of the present invention is used for after-treatment applications occasion, system can be used for（1）By making sacculus in the blood vessel The expansion regular hour measures to stop the hemoperfusion to organ or tissue；With（2）By make sacculus shrink another a period of time come Allow the Reperfu- sion to organ or tissue, sequentially reexpansion（Stop）And contraction（Perfusion）；Alternatively（3）By such as medicine The benefit agent of thing, contrast agent, therapeutic preparation etc. is delivered to the region of balloon distal.

Sacculus can be configured to blood vessel is blocked in expandable members expansion or during expanding, and and then allow to expand Open component to tighten or recover blood perfusion during shrinking.The vascular system of blocking can include the venous blood such as in retroperfusion Pipe, or the arteries such as in Reperfu- sion.The blood vessel of blocking can come from coronary vasculature, peripheral vasculature, big Brain vascular system or other vascular systems.

As shown in the schematic diagram in Figure 1A and Figure 1B, in one embodiment, by from making catheter-balloon by traumatic part The near-end expansion and contraction one or many circulation of position（Circulate from about 10 seconds to 60 seconds until about 30 minutes every time）To realize Post processing.In one example, sacculus expands and maintains about 30 seconds, and then sacculus shrinks and maintains about 30 seconds（Figure 1A）.Another In one embodiment, sacculus expands and maintains less than 20 seconds, and then sacculus shrinks and maintains contraction state about 20 seconds to about 2 points Clock.Repeat these circulations if necessary to performing post processing therapy.Term as used herein " circulation " refers to once complete Expansion and collapse step.For example, expandable members sequentially shrink and expand with allow hemoperfusion about 10 seconds to about 60 seconds or More long and stop perfusion about 10 seconds to about 60 seconds or more long（For example, 30 minutes）Circulate for one or many.In some enforcements In example, it is repeated about 3 times and is recycled to about 10 times or circulates more times.However, it is possible to adopt other post-processing approachs, for example, exist The post processing that the United States Patent (USP) of Vinten-Johansen et al. is illustrated in disclosing No.2004/0255956 and 2007/0160645 Method, the content disclosed by these patents are incorporated by reference in this text for all purposes.However, conduit system described herein System is not limited to post processing operation or is not limited to prevent or reduces reperfusion injury.

In certain embodiments, foley's tube is designed to beating support in the case where implanted stent size is not changed Ink vessel transfusing expansion.So, expandable members are compliant balloons as described below, and the compliant balloon is swollen in sacculus There is no negative influence to implanted support during swollen and contraction.Thus, according to one embodiment, can be in the pipe of implanted support Intracavity occurs including the medical operating program in making sacculus expansion and being contracted in.

When conduit system is used for post processing, as shown in Figure 1A and Figure 1B, can before support is beaten to blood vessel or Be connected on after support being beaten to blood vessel adopt post-processing technology.With regard to the post processing before or after support is beaten, what here was implemented The embodiment of system is designed such that the post processing to blood vessel by without removing the platelet being fixed in blood vessel wall （plaque）.With regard to the post processing after support is beaten, can be in the inside of the near-end of support, the distal end of support and/or support Carry out post processing.Advantageously, when post processing is adopted in the Ink vessel transfusing for beating support, pipe guide embodied herein does not change exhibition The shape or size of the support opened.Therefore, before or after conduit embodiments of the present invention can be used for placing support in the blood vessel The post processing for carrying out.

As shown in Figure 2, conduit system 10 is generally comprised：Conduit with fore and aft axis 200；Expandable members 300；With Fluid circuit containing the control system 1000 being contained in the handle.

In certain embodiments, handle 100（Fig. 3）Conduit system is attached to by non-removable, it is single to provide Integrated device.Advantageously, the packaged use in sight of integrated device（ready-to-use）State in.In other words, device can To be prefabricated unit, which is ready for the blood vessel of any size, thereby eliminates as required by the device of prior art To measuring patient and selecting the needs of suitable dimension sacculus and conduit.Figure 3 illustrates the exemplary enforcement of prefabricated unit Example.When device is removed and coupled with expansion fluid source from any packaging for being provided, as described in more detail below Ground, the device are ready to use.In addition, in the application scenario of delivering therapeutic agent, the device of present subject matter is provided for more Plus effective operative procedure, because quick exchange guidewire can keep staying in conduit cavity during delivering therapeutic agent.At certain In a little embodiments, expandable members 300 are disposed at the distal section of the fore and aft axis of conduit.

Fore and aft axis 200 includes at least two tube chambers, such as in Fig. 4 A to Fig. 4 C preferably findings.In one embodiment, extremely Few two tube chambers include expansion tube cavity and detached, special, independent contraction tube chamber.Expansion tube cavity and independent contraction tube chamber It is in fluid communication with the interior section of sacculus 300, but does not generally have and fluid communication with each other.Specifically, any pressure fluid （Such as carbon dioxide, containing helium, the noble gases of neon etc）And fluid under pressure（Such as saline or contrast agent etc）Expansion Fluid is incorporated in sacculus 300 via expansion tube cavity expands sacculus, and and then out enters independent contraction tube chamber from sacculus. Expansion fluid is one way by the flowing of fluid circuit.Independent contraction tube chamber allows sacculus to shrink rapidly, and such as will be The contraction of venturi assist type is configured to being described below in one embodiment（Venturi-assisted deflation）.

Handle 100 is disposed at the proximal end of conduit or near the end, and the control system in containing fluid loop System 1000（Fig. 2 and Fig. 3）.Handle 100 is configured to enable the surgeon to easily touch by certain embodiments Formula actuator 101 makes expandable members 300 automatically and sequentially expands and shrink.So, a touch actuator can be switch, Button, lever or other devices, its be adapted to allow for user when expandable members 300 in first position or along a first direction Expand expandable members when activateding, and work as expandable members 300 in the second position or activated along second direction When shrink expandable members.One touch actuator advantage is a lot of.It allows operator by easily using switch come easily Pipe guide is manipulated, there is no the difficult and time-consuming operation requirement of traditional angioplasty catheter.The actuating of one switch adds Corresponding reduction the time required to the reduction and enforcement post processing of upper step, it is allowed to which doctor or other meddlers can be by theirs Attention and concern power be focusing more on patient, rather than as tradition angioplasty catheter needed for be absorbed in step With the arrangement of device building block.

Fig. 5 shows the comparison of requirement of focusing on to doctor/meddler.Conduit described herein is represented as Fig. 5 In " PUFF ", the operating procedure which requires is less, and causes doctor/intervention there is provided with the pre-assembled device of trigger action Person focuses more on attention on patient.Additionally, presently disclosed equipment can be by single doctor/meddler behaviour Make, and traditional angioplasty equipment then needs two doctors to operate.

Allow that expandable members 300 sequentially expand and the touch easy manipulation shunk is by making catheter shaft adaptability Ground includes independent expansion tube cavity and detached independent contraction tube chamber to realize.In certain embodiments, switch is configured to Prevent user is from allowing expandable members 300 excessively to expand.Specifically, system can include pulse valve, and which is expansible The outlet port for leading to expandable members is closed when component is completely expanded, excessively expansion is thus prevented.So, when sacculus quilt When expanding completely, the further actuating of switch does not make sacculus further expand, and thus makes system " anti-misoperation ", and realizes The repeatability for expanding expandable members.Fluid circuit need not electrically or electronically device come realize sacculus expansion or shrinkage, Actuating or expansion flowing of the fluid by loop to expansion or shrinkage.So, when sacculus expands completely, switch enters one Step is activated does not make sacculus further expand, and thus makes system " anti-misoperation ", and realizing makes expandable members expand again Existing property.

In certain embodiments, handle 100 includes the control system 1000 of the fluid circuit being disposed in pipe guide. Control system 1000 is configured to the expansion fluid for helping the fluid circuit through conduit system, so that expansible structure Part 300 expands and shrinks.In certain embodiments, as will be described, fluid circuit and especially independent collapsible tube Chamber can be configured to induce the flowing of venturi assist type, so that expandable members 300 are promptly shunk.

II. catheter body

According to one embodiment, as shown in Figure 4 A, conduit includes the tubulose axle 200 of generally lengthwise, and the axle has and is in The proximal shaft sections 201 and distal shaft sections 202 of fluid communication.Proximal shaft sections 201 and distal shaft sections 202 can be by having The material of same or similar hardness or durometer hardness is formed, to provide uniform flexible along catheter body.Alternatively, closely End joint section can be formed by flexible different material with distal shaft sections, to provide the flexible conduit along length change.Example Such as but without limitation, proximal shaft sections can be formed by hypotube, and distal shaft can be formed by polymeric material, to carry For the flexibility increased along conduit tubulose axle.Thus, proximal shaft sections and distal shaft sections can be formed by identical pipe, or standby Selection of land can be two detached pipes, and the two detached pipes are connected or weld together to form integral type pipe.Conduit can To include one or more polymer, or the polymeric blends with different hardness.

As shown in Figure 4 B, in one embodiment, fore and aft axis 200 includes independent expansion tube cavity 203, and which is constructed use In the passage or the flowing that provide expansion fluid to expandable members 300, the expandable members are disposed in the distal end of catheter shaft At end 202 or near the end.Fore and aft axis 200 can also include independent contraction tube chamber 204 to provide second fluid stream Dynamic passage, so as to make expansion fluid flow out from expandable members 300 during shrinking.So, during post-processing technology, can Stop and open with contraction and consequential blood flow with the sequential inflation for effectively and quickly carrying out expandable members 300 Begin.For example, in one embodiment of system, can in five seconds or shorter time, preferably in one second or shorter time, Most preferably in 1/15 second or shorter time expand expandable members 300.Furthermore it is possible in five seconds or shorter time, Preferably in three seconds or shorter time, most preferably in 1/4 second or shorter time shrink expandable members.Make expansible Component expands rapidly and is punctured into post-processing technology and provides using the not getable advantage of traditional angioplasty catheter institute.Such as Shown in Fig. 6, carried out comparative study come the Bulking Time of the traditional angioplasty catheter of comparison and conduit system of the present invention with Contraction time.As reported in the figure, angioplasty catheter needs intimate five seconds（4.81 the second）To expand, and present subject matter Conduit system only needs half second.Thus, catheter expansion of the present invention has got up faster than angioplasty catheter intimate ten times.Work as contrast During contraction time required for both conduits of angioplasty catheter and present subject matter, as a result it is similar.Angiopoiesises Art conduit needs about 7 seconds（6.81 the second）To shrink, and PUFF conduits were in one second contract.Therefore, for eight circulation post processings For technology, angioplasty catheter requires more than 93 seconds（Each expansion/shrink circulation for 11.65 seconds）To complete, and PUFF Catheter design is only at 12 seconds（Each expansion/shrink circulation for 1.5 seconds）Circulation is completed inside.Conduit system described herein is presented Go out rapid effectively expansion and shrink circulation, it is possible to optimize post processing.

Fore and aft axis 200 can form various shapes, and for example, in one embodiment, the axle can have as in Fig. 4 B Shown tubular structure.However, it is possible to adopt other shapes known in the art, such as it is oval.

For example, in addition to expansion tube cavity and contraction tube chamber, fore and aft axis 200 can also include guidewire lumen 205.It is concrete and Speech, guidewire lumen 205 can be configured to the tip 400 from the distal end of fore and aft axis 200 and extend to fore and aft axis 200 more The position of near-end, so as to provide conduit on seal wire（over-the-wire catheter）.Or, fore and aft axis 200 can be by shape Become with recess（It is not shown）, the recess is arranged in the position between the distal end 202 of fore and aft axis 200 and proximal end 201 Place is put, to provide rapid exchange catheter.

According to another embodiment, fore and aft axis 200 can also include medicine delivery tube chamber 206 --- such as infusion of medicine Tube chamber, which is configured to partly to deliver such as useful preparation or other preparations of those as described above.In a reality Apply in example, useful preparation is partly delivered to the region that ischemic events occur.In other embodiments, conduit does not have medicine Delivering tube chamber, instead, arranges the sacculus for being coated with medicine for partly delivering useful preparation on catheter shaft.

In certain embodiments, fore and aft axis 200 includes that four separate and independent tube chamber（For example, expansion tube cavity 203, receipts Draw chamber 204, guidewire lumen 205 and medicine delivery tube chamber 206）.However, it is possible to adopt other to construct.In certain embodiments, The diameter of tube chamber is of different sizes.For example, in certain embodiments, shrink tube chamber diameter dimension about expansion tube cavity straight The twice of footpath size.In one embodiment, as shown in FIG. 4 C, the diameter 203d of expansion tube cavity is about 0.100mm, collapsible tube The diameter 204d in chamber is about 0.200mm, and the diameter 205d of guidewire lumen is about 0.400mm, and the diameter 206d of expansion tube cavity About 0.300mm.Therefore, each tube chamber is may be configured to according to being desired to have various sizes of diameter.

In certain embodiments, as shown in figures 7 a and 7b, fore and aft axis 200 can be formed with many by single extrusion Individual tube chamber, such as four tube chambers as described above.As further illustrated, four tube chambers can be taken in extrusion process To so that stay in polymer web between tube chamber, being extruded 208 and form " I-beam " cross section.I-beam configuration is caused Intensity increase with contribute to conduit trace back through vascular system and without the need for the multiple single pipe and/or knit unit on axle, one In a little embodiments, I-beam construction is can be made as with the intensity equal with braiding axle and the wheel less than braiding catheter shaft It is wide.Therefore, the I-beam configuration drawn in Fig. 7 B allows conduit generally less, and allows have multiple dedicated pipes in catheter body Chamber.

I-beam configuration provides effective shape of the bending and shearing for opposing in the plane of polymer web 208 Formula.So, multiple tube chambers 203,204,205,206 are configured to by the polymer web being disposed between these tube chambers The 208 independent tube chambers being physically spaced apart from each other.The advantage of I-beam shape is that catheter shaft is in conduit along specific direction When pulled more resistant against bending.

In certain embodiments, the different tube chamber of size is arranged in extrusion process or is orientated to form pattern so that Each tube chamber of the maximum tube chamber 205 of size in the less tube chamber 203 of size, tube chamber 204, tube chamber 206（Such as Fig. 4 B and figure Shown in 4C）, so as to the polymer web 208 being arranged between tube chamber 203, tube chamber 204 and tube chamber 205 forms I-beam Pattern（As shown in figures 7 a and 7b）.In certain embodiments, the thickness of the polymer web 208 being extruded substantially is equal to In the bending moment of axle.The bending moment being present in when torque is applied on structural detail in the structural detail makes element curved It is bent.Torque and torque are generally measured as the product of power and distance, so they have unit cattle rice（N·m）, or foot Ft lbf（ft-lbf）.So, it is believed that, fore and aft axis 200 will equally resist bending, but regardless of the bending side to catheter shaft To how.It is also believed to, the catheter shaft for not having these features will bend to different degree according to the orientation of internal blood vessel.

Fore and aft axis 200 can also include distal tip 400（Fig. 4 A）, which has adjacent with the distal end 202 of catheter body The proximal end for connecing or overlapping.In one embodiment, catheter tip 400 includes one or more tube chambers.For example, in a reality Apply in example, tip 400 can include the first tube chamber for be directed at the guidewire lumen 205 of fore and aft axis 200 and with inject tube chamber 206 Second tube chamber of alignment.Guidewire lumen 205 and the catheter tip 400 by being disposed at the distal end 202 of catheter shaft Tube chamber is aligned.The tube chamber of these alignments allows conduit to be connected across on seal wire.Additionally, once seal wire is properly inserted, seal wire can To be removed, and fluid can be passed through with Jing tube chambers.

In one embodiment, tip 400 can be formed by the material softer than tube material so that tip has enough Breaking strength come resist insertion during buckling（buckling）, but with enough flexibility so as to there is no the feelings of seal wire Deform when axially or radially load is undergone in the body in tip under condition.Conduit fore and aft axis 200 is constructed such that seal wire During surgical procedure in tube chamber 205 can pass through and longitudinally translate.

Fore and aft axis 200 can include metal, plastics and composite by various material manufactures, the material.In a reality Apply in example, proximal shaft 201 is manufactured to metal tube, for example, rustless steel hypotube, and can be coated with the poly- of such as PTFE Compound material.Metal tube can also be covered by one or more technique using one or more layers plastic material, the work Skill includes common extruding, dipping, thermal contraction and quiet electrically and thermally coats.In another embodiment, fore and aft axis 200 is manufactured For plastic tube.The material being suitably employed in catheter tube is included but is not limited to：Polyurethane（PU）, such as Tecoflex, Pellethene, Bionate, corethane, Elasteon and its mixture；Polyethylene（PE）, such as PET, PBT, PVDF, Teflon, ETFE and its mixture；Polyolefin, such as HDPE, PE, LDPE, LLDPE, polypropylene and its mixture；Polyamides is sub- Amine；Polyamide；The nylon of all ranks, such as nylon 11, nylon 12, nylon 6,6, nylon 6, nylon 7,11, nylon 11,12, And its mixture；Block copolymer；PEBA type polymers, such as ELY, PEBAX, Ubesta and its mixture and biology Degradable polymer.

Mixture and any composite of the suitable material also including above-mentioned material, the such as bilayer of these materials, three layers, Multilamellar.For example, catheter shaft can be manufactured by pipe, and the pipe includes outer layer and the profit by such as polyethylene or PTFE by made by nylon Internal layer made by sliding material.Metal braid or non-metal knitted thing can also be included in the layer of catheter shaft or between layer.

Catheter tip 400 can be configured between fore and aft axis 200 and wall（Fore and aft axis 200 is between surgery average of operation periods May be rubbed against the wall to promote）Not damaged contact is provided.Catheter tip is so structured that soft tip, and the soft tip is in some embodiments In can be made up of soft tube, soft tube is fixed on distal end 202 and extends beyond the end, or alternatively, Soft tube is fixed on the tube chamber of fore and aft axis 200 and extends beyond the tube chamber.Typically, soft tip is solid by welding procedure It is fixed, but also include other technique for fixing, such as bonding within the scope of the invention.Suitable material for sleeve pipe can be selected From any material for being suitable to manufacture fore and aft axis 200.Sleeve pipe can be by the material manufacture softer than fore and aft axis 200, and can be by Formed with 300 identical material of expandable members or formed by different materials, for example, the material by described by with reference to fore and aft axis 200 Material or combination in any one formation.In one embodiment, manufacture sleeve pipe material basic composition with it is expansible 300 material of component or 200 material of lengthwise pipe are identical, but the Shore durometer hardness of the material of manufacture sleeve pipe is less than expansible structure 200 material of 300 material of part or lengthwise pipe.In another embodiment, sleeve pipe can be by PEBAX55D polymer and PEBAX63D The mixture manufacture of polymer.Those skilled in the art will recognize that, sleeve pipe can be by according to each of material described above Other materials manufacture is planted, such as by polyurethane, polyethylene, polyolefin, polyimides, polyamide（Such as nylon）, block copolymer Or the mixture of these materials, synthetic or by these materials double-deck or multilamellar manufacturing.

III. expandable members

According to one embodiment of present invention, expandable members 300 are polymer sacculus.Preferably, sacculus 300 is to comply with Property sacculus.It is different from the typical blood vessel plasty sacculus for being configured to provide new circular open tube chamber, the present embodiment it is poly- Compound sacculus 300 should have enough compliances, to coincide with the anatomical structure of blood vessel.So, sacculus 300 can be blocked With the blood vessel from about 2mm to the diameter of about 30mm, it is for coronary vasodilator, cerebral blood vessel or peripheral blood vessel according to application scenario Situation depending on.In one embodiment, for coronary vasodilator or cerebral blood vessel application scenario, sacculus can be about Block under the pressure of 0.5atm to 2atm with the blood vessel from about 2mm to the diameter of about 4.5mm.For peripheral blood vessel application scenario For, sacculus can be blocked with the blood vessel from about 4mm to the diameter of about 30mm, or any tube chamber aperture of human body is (herein Fluid flow blockage can be curative).

In one embodiment, sacculus is the sacculus of " a kind of size meets all sizes ".Specifically, sacculus must be by Compliance polymeric material is formed.For example but without limitation, compliant balloon 300 is when the Ink vessel transfusing in narrow dimension expands Can elongate, and there can be spherical form when in larger or wider Ink vessel transfusing expansion.Thus, sacculus can be kissed with blood vessel Close.Therefore, doctor need not be in the tremulous pulse of the pre-test patient for carrying out post processing so that sacculus 300 is sized for patient.

In one embodiment, sacculus 300 is mounted to the fore and aft axis 200 of conduit.Sacculus 300 includes hollow inside portion Point, the interior section limits inflation channel, and inflation channel extends longitudinally through the interior section, so as to from fore and aft axis 200 Expansion tube cavity 203 receive expansion fluid.In one embodiment, the proximal part of sacculus 300 can be configured in sacculus It is radially inwardly tapered at 300 proximal end and distal end.The size of the proximal end and distal end of sacculus 300 is set Fixed, to be mounted and sealed to the appropriate section of fore and aft axis 200, and the interior section of sacculus is configured for from unexpanded First state is optionally expanded into the second state of expansion.Therefore, the lateral cross-sectional dimension of the sacculus 300 in expansion state The significantly more than lateral cross-sectional dimension for being inwardly tapered end sections of the proximal end and distal end of sacculus.

When sacculus 300 is mounted to fore and aft axis 200, the expansion tube cavity 203 of fore and aft axis 200 is led to the expansion of sacculus 300 Road is in fluid communication.Therefore, controlled by operating the touch at the proximal end of conduit system as described below System, the interior section of expandable members 300 can optionally be expanded into the second state of expansion from first state.

The distal shaft 202 of fore and aft axis 200 extends through the inflation channel of sacculus 300, and the wherein distal end of conduit terminates In the far-end of the distal end of sacculus 300.As best illustrated in Figure 4 A, distal shaft 202 extends lengthwise through sacculus 300 interior section, and limit the distal portions of guidewire lumen 205, the distal portions of wherein guidewire lumen 205 terminate at vertical At remote port at the distal end of major axis 200.Therefore, seal wire（It is not shown）May extend through the seal wire of fore and aft axis 200 Tube chamber 205, and by the remote port of distal end of catheter end out.This passage enables conduit along can be tactful Arrangement seal wire in the blood vessel in ground advances.

Sacculus 300 can form variously-shaped, as shown in Figure 8A and 8B.As illustrated, the shape of sacculus 300 can be Spherical, cylindricality or polygon.Can select as will in the art known to various polymer forming sacculus 300.So And, balloon material should have enough compliances so that sacculus 300 can be coincide with the shape of blood vessel.

In one embodiment, sacculus 300 can be by such as（Thermedics）Poly- ammonia Ester material is formed.It is thermoplastic aromatic's EU, which is by methylene diisocyanate （MDI）, polytetramethylene ether diol（PTMEG）Synthesize with the agent of Isosorbide-5-Nitrae chain expansion of succinic acid.Grade 1065D is presently preferred, Shore durometer hardness, about 300% elongation at break and about 10000psi which has 65D High yield tensile strength.However, it is possible to use other appropriate grades, including1075D, its tool There is the Shore hardness of about D75.Other appropriate compliance polymeric materials include：（DuPont Dow Elastomers（Ethylene alpha-olefin polymer）With（Exxon Chemical）, the two is all thermoplasticity polymerization Thing；Elastomer silica gel；And latex.

Conforming materials can be crosslinking or noncrosslinking.Currently preferred polyurethane balloons material is not crosslinking. By the final size that the crosslinking of sacculus conforming materials can be controlled dilatation balloon.

Can use including the traditional crosslinking technological including heat treatment and electron beam exposure.In crosslinking, initial press, expansion After preshrinking, the bulbs of pressure thus in response to giving are expanded to reproducible diameter by sacculus in a controlled manner.

In one embodiment, sacculus 300 is formed by the low drawing and setting polymer of such as silicone-polyurethane copolymer. Preferably, silicone-polyurethane is ether polyurethane, and especially fatty ether polyurethane, such as PURSIL AL575A and PURSIL AL10（Polymer Technology Group）And ELAST-EON3-70A（Elastomedics）, they are silicon Ketone polyether-polyurethane copolymer, and especially fatty ether polyurethane siloxane copolymer.

In an alternative embodiment, low drawing and setting polymer is diene polymer.Can be poly- using various appropriate dienes Compound, such as but not limited to isoprene, such as AB and ABA gather（Styrene-b-isoprene）, neoprene, AB and ABA gathers（Styrene-b-butadiene）, such as styrene butadiene styrene（SBS）And styrene butadiene ribber（SBR） And 1，4-polybutadiene.Diene polymer can be isoprene, and which includes isoprene copolymer and isoprene block altogether Polymers, for example, gather（Styrene-b-isoprene）.Currently preferred isoprene is styrene-isoprene-phenylethene Block copolymer, the Kraton1161K that for example can be obtained from Kraton Inc.However, it is possible to use various appropriate isoamyls two Alkene, including can be from the HT200 that Apex Medical are obtained, the Kraton R310 that can be obtained from Kraton and can be from Dupont The isoprene that Elastomers is obtained（That is 2- methyl isophthalic acids, 3- butadiene）.Neoprene grade useful in the present invention includes Can be from the HT501 that Apex Medical are obtained and the neoprene that can be obtained from Dupont Elastomers（That is polychlorostyrene fourth two Alkene）, including the neoprene G types, W types, T-shaped and A types that can obtain from Dupont Elastomers.

In one embodiment, polymeric material is conforming materials, such as but not limited to：Polyamide/polyether block is common Polymers（Commonly referred to PEBA or polyether block amide）.Preferably, the polyamide of block copolymer and polyethers sections can lead to Superamide or ester are chain attachment.Polyamide-block can be selected from various aliphatic known in the art or aromatic series polyamides Amine.Preferably, polyamide is aliphatic.Some non-limiting examples include nylon 12, nylon 11, nylon 9, nylon 6, nylon 6/12nd, nylon 6/11, nylon 6/9 and nylon 6/6.Preferably, polyamide is nylon 12.Polyether block can be led selected from this technology Known various polyethers in domain.Some non-limiting examples of polyethers sections include gathering（Tetramethylene glycol）, it is tetramethylene ether, poly- It is ethylene glycol, polypropylene glycol, poly-（Pentamethyl ether）With it is poly-（Hexamethyl ether）.Can also use can be commercially available PEBA materials Material, such as by Arkema（France）SupplyMaterial.For forming ball from polyamide/polyether block copolymer The various technologies of capsule are known in the art.Disclose in United States Patent (USP) No.6406457 of Wang one it is this Example, the content disclosed by the patent are incorporated by reference in this text.

In another embodiment, balloon material is formed by polyamide.Preferably, polyamide has suitable stretching strong Degree, or even also can prevent from forming pin hole after folding and opening（pin-holing）, and generally there is scoring resistance, example The polyamide as disclosed in United States Patent (USP) No.6500148 of Pinchuk, the content disclosed by the patent is by quoting It is incorporated in this text.Include nylon 12, nylon 11, nylon 9, Buddhist nun suitable for some non-limiting examples of the polyamide material of sacculus Dragon 69 and nylon66 fiber.Preferably, polyamide is nylon 12.In yet another embodiment, sacculus 300 is by some different layer structures Into each layer is different polyamide or polyamide/polyether block copolymer.

In another embodiment, sacculus 300 is designed to have the minimum volume and with blood vessel wall most for expansion Little contact.As seen in fig. 8 c, sacculus can have bulb columnar structure.As illustrated, sacculus can via sacculus shoulder with lead Pipe axle is associated.The tapered portion of sacculus to balloon diameter maximum point and can be gradual change and/or it is precipitous with minimize with The contact of blood vessel wall.In addition, sacculus is preferably formed by the material of height compliance, such as but not limited to 45 to 50 it is hard Degree meter hardness, silicone or other there is the thermoplastic elastomer (TPE) of height compliance.In certain embodiments, ball Capsule has variable maximum gauge, and the maximum gauge can be added by changing for making the volume of the expansion fluid of sacculus expansion To control.For example, maximum gauge can be changed between about 2mm and 5mm by controlling the introducing of expansion fluid.Expansion and receipts Contracting speed can be with optimised.As the shape of sacculus is configured to the form for being substantially non-columnar, sacculus will with allusion quotation Type semi-compliant or non-compliance spherical balloon are compared less internal volume to reach identical maximum gauge.The inside of reduction Volume can cause expansion and contraction rate faster.In one embodiment, sacculus shoulder can combined it with catheter shaft Before be squeezed.In this aspect, the gradient of tapered portion is maximized, and that further reduces sacculus in expansion with blood vessel wall Contact length.

In another embodiment, sacculus includes the multiple spires along its curved shape.These spires are set For by sacculus initially preferably folding, and in destination object blood vessel is inserted into during preferably chase after along guiding catheter Track.In one embodiment, sacculus does not have spire when heaving or shape.Can be fastened by the side by sacculus（For example, Welding）Balloon material is reversed again to catheter shaft with formed it is spiral-shaped and while torsion formation is kept by the relative of sacculus Side is fixed（For example, weld）Spiral is formed to catheter shaft.However, compliant balloon is typically lost after initial bubble Its shape, even can also remain spiral-shaped after sacculus initial bubble by torsional compliance sacculus in the above described manner. Sacculus is configured to along groove refolding during shrinking, and this makes the sacculus of refolding have less profile.

In yet another embodiment, as shown in Fig. 8 E to Fig. 8 G, sacculus can be with dimpled sacculus（fluted catheter）300"'.Perspective view with dimpled sacculus is shown in Fig. 8 E.Sacculus is included along balloon surface in axial direction Longitudinal fluting on direction.Groove is produced with dimpled balloon surface and pleated portions, and sacculus is carried due to the region of groove For difference of hardness and along the pleated portions refolding.In one embodiment, groove is arranged along the maximum gauge of balloon surface. In one embodiment, sacculus includes multiple grooves of the maximum gauge along balloon surface.Fold was included transverse to sacculus week To the longitudinal fluting of axis shaping, as shown in Fig. 8 F.Sacculus can have the first tapered portion and in the opposite direction the Two tapered portion（For example, near-end tapered portion and distal end taper portion）.The maximum of first tapered portion and the second tapered portion in balloon surface Intersect at diameter.In one embodiment, longitudinal fluting is arranged along first tapered portion and the second tapered portion of sacculus.Groove Shape fully can change.For example, groove can have the substantially shape of " u "-shaped or " V " shape, round-shaped or other shapes Shape, the shape provide the hardness for changing to promote effective refolding of sacculus.

According to some embodiments, sacculus 300 can be made up of single polymeric layer, or can be alternatively multiple stratification ball Capsule, for example Ishida United States Patent (USP) No.5478320, Trotta United States Patent (USP) No.5879369 or the United States Patent (USP) of Lee Those described in No.6620127, the content disclosed by these patents are incorporated by reference in this text.

IV. handle and fluid circuit

As described above, conduit system includes handle 100, and the handle is arranged substantially at the proximal end of conduit Or near the end.The size and dimension of handle is configured to cosily to be received in doctor's handss.Handle 100 can be with Including with variously-shaped and construction shell, as shown in Fig. 9 C to Fig. 9 R.In one embodiment, handle 100 is by can not It is attached to conduit with removing, so as to system becomes the integrated device for needing to assemble before the use.In other words, conduit system can To sell in the state of " i.e. with ", this is different from traditional angioplasty catheter as described above.

Fluid circuit is generally included：Along the expansion tube cavity and independent contraction tube chamber of the arrangement of catheter shaft 200；It is arranged in Control system in handle 100；With multiple valves, controlling and adjust expansion fluid by conduit system pulsation and/or The flowing of regulation and control.Fluid is " closure " fluid circuit, therefore the building block in the loop is not exposed to air.As a result, expand Fluid is down to atmospheric pressure when being comprised in fluid circuit.

In certain embodiments, fore and aft axis 200 includes ingress port and outlet port.Ingress port is by from as fluid The expansion fluid stream pressurization of the first reservoir of 1000 part of loop control system.Expansion flow of fluid is by fore and aft axis 200 Expansion tube cavity 203, enters the interior section of expandable members 300 via ingress port.Expansion fluid enters expandable members 300 Internal flowing causes expandable members expansion and the blood flow in blood vessel is blocked when being placed in the blood vessel.It is arranged in fore and aft axis Outlet port on 200 helps expandable members 300 to shrink by providing opening, described to be open for receiving expansion fluid Flow to contraction tube chamber 204 from expandable members 300 during contracting.

Outlet port is configured to help the venturi assist type flowing in tube chamber 204 is shunk, expansible to make Component 300 shrinks.For example, expansion tube cavity 203 and contraction both tube chambers 204 can be opened wide in expandable members 300.Expansion stream Body can be entered by expandable members 300 from expansion tube cavity 203 and be shunk in tube chamber 204.Expansion tube cavity 203 and contraction tube chamber 204 are coupled together by a series of one way stop peturn valves.In one embodiment, the bulbs of pressure cause contraction check-valves to remain turned-off. In check-valves and the rear side of pulse valve（back side）The pressure of upper accumulation（Figure 10；117th, 112 and 109）Produce venturi effect Should shrink so that promotion is rapid.When actuator being maneuvered to punctured position, the pressure on the rear side for shrinking check-valves is removed. Therefore check-valves are opened, and expandable members 300 can be shunk.The bulbs of pressure exhaust rapidly generation Venturi effect, i.e. expansion Exhausting rapidly for pressure declines balloon pressure（draw down）, and expansion fluid is pulled together by shrinking tube chamber to device Floss hole in handle.Floss hole is not opened wide to air.In fluid circuit between the floss hole in contraction tube chamber and handle It is positioned with valve.When expansion fluid under Venturi effect when pulled, spring up expansion fluid pressure open valve, so as to shrink Fluid can be discharged in handle.When contraction fluid is drained from fluid circuit, valve cuts out to keep fluid circuit to cut out.Cause And, expandable members are in the time contract less than a second, and in certain embodiments, expandable members are less than 1/4 second Time contract.

According to another aspect of the present invention, can expand via trigger as described above or button control sacculus And contraction.This have the advantage that, which allows sacculus promptly to expand and shrink, and allow for example for after-treatment applications When shorter Reperfu- sion circulation time.Figure 11 is illustrated and is implemented for here and described conduit system（Referred to as " PUFF "）And biography System angioplasty catheter device（Referred to as " AngioPC "）Bulking Time and contraction time contrast.As illustrated, of the invention Conduit system compared with traditional angioplasty catheter expand and shrink with the speed of excess.With can be with about 0.50 second The pipe guide of the present invention of speed expansion is compared, and the expansion of plasty conduit is about 4.84 seconds.Shrink result and angiopoiesises are shown Art conduit was shunk with least 6.81 seconds, and the conduit of the present invention can be in about 1.0 seconds contracts.

In one embodiment, as shown in Figure 12, control system 1000 includes actuator 107, and which can be light in finger Hit the lower expansion and contraction for activating expandable members 300.Actuator 107 can activated sacculus is sequentially expanded and shrink with For after-treatment applications occasion or other application occasion.It has been found that the ischemia of a period of time or middle Herba Clinopodii（For example but not limit During STEMI or other infractions）Opening rapidly tremulous pulse afterwards can cause reperfusion injury.A kind of reduction reperfusion injury Method is to be engraved in the tremulous pulse of infraction sequentially to start and stop after initial flow is reopened from STEMI or other obstructions Hemostasis stream is repeatedly circulated.The present invention is designed to realize rapid effective and reproducible post processing for the system that doctor provides.Bag Include control system 1000 fluid circuit 110 be designed to allow need not other be input into or electronic device in the case of by Single actuator 107 carrys out operating system, and which is referred to as " touch ".Actuator 107 can be configurable to include for making to expand Open the first position or direction and the second position or direction for making the contraction of expandable members 300 of the expansion of component 300.For example, Actuator 107 can be button（Fig. 9 F）, switch（Fig. 9 A）Or lever（Fig. 9 B）, which has for activating the instantaneous of sacculus expansion Direction and for activate sacculus contraction can braking direction.By by doctor interact be limited to only one switch, button or Lever, can provide the repeatability in terms of the expansion and contraction of expandable members 300 according to the time requirement of post processing.Cause This, fluid circuit design and a touch are activated and are provided using easiness and degree of reproducibility for post processing.In addition, here is implemented Device allow the doctor of management post processing to pay close attention to watch-dog or miscellaneous equipment instrument, this with must pay close attention to device during use Situation completely contradict.

In one embodiment, expand fluid the regulation that the Fluid pressure of sacculus 300 is led in control is discharged into from reservoir 101 Device or single pressure check valve.As fluid circuit is not opened wide to air, the expansion fluid being conditioned is not lowered to atmospheric pressure Power.The expansion fluid being conditioned is by the stream of suction line 106 to actuator 107（For example switch）, the actuator control expansion stream Body is by check-valves stream is to pulse valve 113 and is flowed to sacculus 115 then.

The permission expansion fluid of pulse valve 113 is in valve with the specified time period from ingress port stream to outlet port.Such as will Ground is described below, can for example by the size of the ingress port in setting pulse valve, outlet port and relative spring pressure To specify the time.Such as in Figure 11 A to Figure 11 C preferably illustratively, in one embodiment, pulse valve 113 includes being disposed in Inwall 1401 in cylindrical body 1400.Cylindrical body 1400 has first end 1410 and relative the second end 1411.Tool There are ingress port 1406 and the inwall 1401 of outlet port 1407 to be disposed between first end 1410 and the second end 1411 Body 1400 in.Preferably, ingress port 1406 is more than outlet port 1407, to make expansion fluid pass through ingress port stream Enter the speed in the cylindrical body between the second end 1411 and inwall 1401 and be faster than and flowed by outlet port 1407 The speed of the cylindrical body between one wall 1410 and inwall 1401.Therefore, with the expansion Fluid Volume phase for leaving outlet port 1407 Expansion Fluid Volume in the entrance ingress port 1406 of contrast causes Fluid pressure to tire out between the second wall 1411 and inwall 1401 Product.As a result, as shown in Figure 11 B, when the pressure of accumulation promotes inwall, the pressure of accumulation applies active force to inwall, and most The intensity of spring 1402 is overcome eventually and causes spring-compressed.The contact of inwall 1401 is disposed in the stop structure in cylindrical body 1400 Part 1405.In certain embodiments, retainer is arranged on the inner surface of cylindrical body.The retainer is disposed in the port of export The near-end of mouth 115, the outlet port are directed to such as sacculus 300（It is not shown）Expandable members path.Such as institute in Figure 11 C Show that the contact retainer 1405 of inwall 1401 becomes axially to be aligned with the outlet port 115 for leading to sacculus 300.When inwall 1401 When being axially aligned with outlet port 115, the path provided by port is blocked so that not expanding that fluid can advance to can Expansion 300.Therefore, pulse valve 113 provides the actuator of a kind of " anti-misoperation ".Specifically, even if doctor continues to press Hydraulic actuator is expanded by expandable members 300, but can not expand further expandable members, because outlet 115 is by inwall 1401 blockings.Thus, even if taking other trial to expand, before more expansion fluids can be by system, it is also necessary to First by the system cut-off.Thus, system can safely control the Fluid Volume into expandable members.Expansion fluid can be this Known various fluids in technical field.For example, it can be gaseous fluid or liquid fluid to expand fluid.In illustrative mesh , expansion fluid can be carbon dioxide or saline.

In another embodiment, fluid circuit includes that the venturi assist type of expandable members shrinks.So, produce Vacuum is so that the expansion fluid from expandable members promptly shrinks.Specifically, when contraction is activated by doctor, pulse valve It is de-energized, the fluid in pulse valve is escaped so as to discharge the pressure on rear side of check-valves, this generates Venturi effect so that ball The time that capsule shrinks shortens.In certain embodiments, expandable members are preferably being lacked in the time contract of less than about 5 seconds In the time contract of about 3 seconds, more preferably in the time contract less than 1 second.

As described herein, control loop 1000 as shown in figure 12 includes fluid circuit 110, and the fluid circuit is substantially It is upper to include pipeline 106（Figure 10）With multiple check-valves, pass through fluid circuit most Zhongdao fore and aft axis 200 to regulate and control expansion fluid The flowing of expansion tube cavity, expansion tube cavity and the fluid circuit 110 and expandable members 300 of fore and aft axis are in fluid communication, and pass through Independent contraction tube chamber is returned.The exploded view of one embodiment of fluid circuit is shown in Figure 10.It is housed in handle 100 Fluid circuit 110 can include consisting of part：For providing the first reservoir 101 of inflating liquid under pressure, for example but not limit In BestWhip（LG）（Genuine Innovations, Part2042 or 4130）（Figure 13 A）；For controllably water conservancy diversion One reservoir 101 penetrates mechanism 103, such as such as lancet assembly, SA00102, SA00068, SA00101 or MM235008- 21N、MM235008-11N（Genuine Innovations）（Figure 13 B to Figure 13 F）；For control from expansion fluid to can expand Open the pressure regulator 104 of the pressure of component 300（MAR-1 is respectively for example（Clippard）Or SA00196（Genuine Innovations）, Figure 13 G to Figure 13 H）.It is alternatively possible to single pressure check valve or constant pressure regulator are used, for example, Qosina-P/N11582 or " Lee Chek " Part Number CCPI2510014S,（Figure 13 P）；To by pressure regulator 104 adapters 105 for being connected to tubular element 106（It is not shown）, for example, UTO-2-PKG（Clippard）（Figure 13 I）；For The actuator 107 of the flowing that control expansion fluid is entered in expandable members 300 from the first reservoir 101, such as master switch, such as FBV-3DMF（Clippard）（Figure 13 K）；For tubular element 106 to be connected to the company of actuator 107 from pressure regulator 104 Connect device 108, for example, CT2-PKG（Clippard）（Figure 13 J）；For the diverter 109 to expanding divided fluid stream, for example, UT0- 2002-PKG（Clippard）（Figure 13 L）；Adapter 111, such as CT2-PKG（Clippard）（Figure 13 M）, the adapter is used for Diverter 109 is connected to into pulse valve 113, such as PV-1 by tubular element 112（Clippard）（Figure 13 N）, so as to by one The controlled pulse for determining the expansion fluid of volume is delivered to expandable members 300；Adapter 114, such as rotational connector, such as UTO-2-PKG（Clippard）（Figure 13 O）, the adapter is to be connected to one way stop peturn valve 115 by pulse valve 113（For example, CCPI2510000S（Lee Company）Or Qosina-P/N11582（Figure 13 P））, one way stop peturn valve permission expansion fluid stream To expandable members, and guarantee that the flow direction for expanding fluid is only unidirectional, i.e., from pulse valve 113 to the swollen of fore and aft axis 200 Tube expansion chamber 203；Diverter 116, such as UT0-2002-PKG（Clippard）（Figure 13 R）, which passes through tubular element 117 and is connected to Diverter 109, wherein diverter self-constriction in 109 future tube chamber 204 it is hose connection to pressure indicator 118；Pressure indicator 118, such as IND-1-WH（Clippard）（Figure 13 S）, which is used to illustrate the pressure shunk in tube chamber 204 to guarantee expansible structure Part 200 is inflated；Double hose barbs 119（It is not shown）, such as C22-PKG（Clippard）（Figure 13 Q）, for by check-valves 120 are connected to the flexible pipe for leading to conduit；And check-valves 120, such as CCPI12510000S（Lee Company）（Figure 13 T）, To guarantee to expand flow direction of the fluid from the outlet tube chamber on conduit pulse valve to entrance tube chamber 203.As shown, Fluid circuit does not need electronic device to operate.

As shown in the block diagram of Figure 14 A, in operation, expand fluid（It is carbon dioxide in this example）By penetrating Storage state of the mechanism 103 from the first reservoir 101 is flowed out.Expansion fluid stream enters in main valve or actuator switch.At some In embodiment, the flowing for expanding fluid is stopped turnover main valve.As shown in Figure 14 B, fluid circuit can be configured to permit Perhaps expand fluid to flow in second check-valve through valve.In certain embodiments, it is allowed to which gas flows about 0.1 second.During this section of Jing Between after, the second valve can be configured to no longer allow expansion flow of fluid.Check-valves allow expansion fluid stream to enter in sacculus but Do not flow out from sacculus.3rd check-valves allow expansion fluid to flow out from sacculus but do not flow into sacculus.When expansion fluid（Such as dioxy Change carbon gas）When flowing expansion check-valves, expansion fluid has higher pressure, so system is now locked（Expansion）.Separately Outward, as shown in Figure 14 C, thus the pressure depletion inside the second valve produces venturi power as mentioned above, with all gas Body is discharged from the top of main valve and sacculus is drawn in punctured position.Now, main valve does not allow gas to flow into.Therefore, fluid is returned Road allows user makes expandable members sequentially expand and shrink in rapid continuous easily mode.Handle can also include arteries and veins Valve is rushed, flowing is delivered to sacculus 300 in the way of by time control or by fixing fabric structure.In this aspect, second pipe Shape component can include one way stop peturn valve, the carbon dioxide delivered by pulse valve is locked in expandable members 300.

V. indicator

Shrinking tube chamber in certain embodiments includes indicator --- such as but not limited to pressure monitor --- to guarantee Sacculus expands.In certain embodiments, pressure monitor is disposed in sacculus and shrinks and expanded with guaranteeing sacculus between check-valves. For example, if conduit can not be allowed expansion by knot, it indicates that device would not indicate and expand.In addition, if conduit is at sacculus There is leakage, it indicates that device would not indicate and expand.Therefore, indicator is the authentic testing of sacculus expansion.

In one embodiment, indicator 118（Fig. 9 A, 9B, 9C and Figure 10）Or pressure marker is arranged in the near of system End end.In one embodiment, indicator 118 includes the protruding member being associated with the contraction tube chamber of system.At some In embodiment, indicator 118 is configured to be extended through when pressure is sensed in the contraction tube chamber of system at least in part Handle 100.So, indicator orientation can be the state that doctor points out expandable members.In other words, when indicator is due to for example Pressure force button to extend and stretch out from handle casing 100 and by doctor it is visible when, doctor can be appreciated that expansion fluid can The fact that in expansion.On the contrary, the indicator do not stretched out from handle 100 informs user expandable members without completely swollen It is swollen.As indicator is associated with the contraction tube chamber at the proximal end of system（For example it is connected）, indicator is only next The pressure of self-inflating fluid has passed through expansion tube cavity and expandable members are in fluid communication and pass through contraction tube chamber and return to system Proximal section till could indicate or extend.Thus, unless expandable members are expanded at the distal section of conduit system, no So indicator 118 would not instruct that pressure.Advantageously, indicator is the instruction of balloon interior true pressure.On the contrary, and collapsible tube The indicator of chamber not in direct fluid communication will not truly indicate that sacculus is swelling state or contraction state.

VI. loading attachment

In one embodiment, as shown in the sectional view in Fig. 9 A and Fig. 9 B, and best referring to Figure 10, fluid is returned The control system 1000 on road 110 generally includes the first reservoir 101（Such as container or tank）, which has the expansion stream for having stored Body.First reservoir 101 can be chosen（Based on size）So that the specific sacculus expansion with special size and contraction.Therefore, Selected reservoir size can prevent from reusing and/or promoting safety, especially when expansion fluid is gas-pressurized（Such as dioxy Change carbon）When.

In certain embodiments, loading attachment 114（Figure 15 A）The near-end of the first reservoir is disposed in, and is constructed use In device is loaded.Loading attachment can be irreversible.In this aspect, " irreversible " means once the device of the present invention It is loaded, then can not be released from loading.Before the use, loading attachment 114 is activated to penetrate containing expansion fluid by doctor Reservoir 110.For example as shown in Figure 15 A and Figure 15 B, when loading attachment 114 is pushed down, the first reservoir 101 is pushed forward, And the ratchet on handle casing 112 is engaged with protuberance 116, so as to prevent loading attachment 114 from returning to its raw bits Put.System is loaded, and thus allows open flow of the fluid from the first reservoir 101.

The other embodiments of loading attachment 114 are shown in Figure 15 C to Figure 15 N.For example, in Figure 15 C and Figure 15 D, dress Carry and put 114 and formed by button 114a and wedge 114b, button and wedge are positioned such that to be applied on button 114a Down force cause wedge 114b along movement in vertical direction, the expansion being stored in from there through release in reservoir 101 Fluid makes the first reservoir 101 move forward in " loaded " position.Protuberance 116 again with the ratchet on the handle casing 112 Engagement, so as to prevent both button 114a and wedge 114b from returning to its home position.

Level type safety device 114 is shown in Figure 15 E to Figure 15 J.As illustrated, doctor must be by lever from first Position moves to the second position, to make the first reservoir 101 proceed in its " loaded " position.Lever loading attachment 114 it is initial Position and final position are dependent only on the manufacture requirements of system.In certain embodiments, on 112 side of handle casing Ratchet is engaged with the both sides of lever loading attachment 114, thus prevents lever loading attachment 114 from returning to its home position.

Can also some embodiments of the invention using pulling-on piece type loading attachment as shown in Figure 15 K to 15L 114.In these embodiments, pulling-on piece type loading attachment 114 can be formed by pulling-on piece 114c and spring mechanism 114d.Spring is inclined It is pressed in the state of contraction, till pulling-on piece is removed.By pulling-on piece 114c being removed from handle 100 allow spring mechanism 114d Elongation, spring apply active force and promote or allow the first reservoir 101 to engage guiding device（Such as lancet）, so as to device is filled Carry.

In other embodiments, loading attachment 114 can be screw type loading attachment, such as the institute in Figure 15 M to Figure 15 N Show.As illustrated, the screw thread 114e on loading attachment 114 engages the opening in shell 112.Rotate along appropriate direction and fill Carry and put 114 and cause loading attachment 114 to advance forward, and cause the first reservoir 101 to proceed in its " loaded " position.At some In embodiment, loading attachment 114 can include locking mechanism（It is not shown）, its prevent the first reservoir 101 be released from load and/ Or rotate along the opposite way round.

As described, loading attachment 114 is by making the first reservoir 101 and penetrating component 103（Fig. 9 A, Figure 10）Engagement and First reservoir 101 is loaded so that reservoir is by water conservancy diversion or penetrates to discharge the expansion fluid for being contained in reservoir inside the shell.Flow out Fluid is into fluid circuit and eventually flows into the expandable members at the distal ports of catheter body for expansion, and via independent receipts Flow out from sacculus in draw chamber.

VII. the local application of benefit agent

As described above, the conduit that here is implemented can be included for delivering the injection tube chamber 206 of benefit agent.Note Enter tube chamber 206 to be configured to before, during or after post-processing technology partly apply medicine or other therapeutic agents To the region that ischemic events occur.In this aspect, the benefit agent of effective dose partly can be applied by the medical treatment for being provided With so as to alleviate the reperfusion injury of the tissue or organ that are already subjected to or are undergoing ischemia.

Therefore, according to one aspect of the present invention, there is provided a kind of to be used to alleviate histic infarct side after ischemic events Method.In one embodiment, the method makes sacculus expand in intravascular, to block blood at least in part in first time period Pipe.First time period can be about five seconds or it is less until the time, ten seconds of five minutes or it is less until five minutes when Between, 15 seconds or less until the time, 20 seconds of five minutes or less until the time, 30 seconds of five minutes or less Until the time of five minutes.Then, sacculus shrinks in intravascular so that allow in second time period Reperfu- sion at least in part Blood flow.Second time period can be longer or shorter than first time period.For illustrative purposes, second time period can be five seconds Or it is less until the time, ten seconds of five minutes or less until the time, 15 seconds of five minutes or less until five points The time of clock, 20 seconds are less until the time, 30 seconds of five minutes or less until time, 40 seconds of five minutes Or it is less until the time, 50 seconds of five minutes or less until time of five minutes.Allowing to fill again at least in part After note, sacculus can be expanded at least in part to block blood vessel in the 3rd time period, and and then sacculus is shunk to allow again Secondary Reperfu- sion at least in part.These steps can repeat in a sequential manner, benefit agent can also during expansion step, Ischemic area is delivered to during collapse step or during two steps partly.In one embodiment, only filling again Benefit agent is applied during note step.In another embodiment, deliver benefit agent to circulate down to eight post processings per 30 seconds. After this manner, circulation refers to expansion step（Blocking）And subsequent collapse step（Reperfu- sion）.

The another aspect of theme according to disclosed by current, the apparatus and method of the present invention were significantly reduced in the post processing phase Between required for radiography dosage.Although contrast agent typically use it is safe, apply various contrast medias can cause it is many Plant health.Reaction can sometimes result in death from slightly to serious.The risk factor of development severe reaction include strongly Allergy, bronchial asthma, heart disease and beta-blocker are used.Therefore, the usage amount for reducing contrast agent is conducive to reduction of patient The risk of untoward reaction.For example, reduce contrast agent use is for diabeticss and other crowds with complication are Preferably.

As shown in Figure 16, the Reperfu- sion system of the present invention by represented by " PUFF " chart has used the contrast agent of 0.37ml To confirm post processing blocking and the Reperfu- sion of eight circulations, and the traditional angioplasty technology by represented by " AngioPC " makes With the contrast agent of 7.75ml.Therefore, the contrast agent needed for traditional angioplasty catheter is almost embodied herein and institute 21 times of the pipe guide of description.Thus, the apparatus and method of the present invention fully reduce contrast agent exposure.It is right as more than In delivering therapeutic agent described by, contrast agent can be delivered to outlet or the end for being positioned in balloon distal by the tube chamber of conduit Mouthful.The a series of images described by Figure 17 illustrates the Reperfu- sion that contrast agent is deployed at the port 250 of 300 distal end of sacculus and follows Ring（Arrow " A " indicates flow direction）.As outlet is disposed in the distal end of sacculus, sacculus can be made first to expand to block blood Stream, then can be with delivery of contrast agents.In the case where blood flow is blocked, contrast agent will not be diluted or be forced downstream.As a result, The present invention provides preferably control and visibility while less contrast agent is needed.

Therapeutic agent delivery and the effect being absorbed by the patient can be strengthened in balloon distal positioning delivery port.Although in Figure 16 In depict single port 250, but according to expecting to include extra port.In addition, contrast agent and therapeutic agent can be with roots It is arranged on according to expectation and has in the detached tube chamber of detached outlet in balloon distal.In another embodiment, retouched at present The catheter shaft for stating theme can include detached tube chamber to deliver contrast agent detached with benefit agent.Tube chamber can be according to expectation Near-end or the distal end of sacculus are disposed in, such that it is able to contrast agent and/or benefit agent to be delivered to near-end or the distal end of sacculus.

VIII. using the exemplary application of conduit

The conduit that here is implemented and described can be used for various application scenarios, including localized drug delivery, post processing and blood Tuboplasty.In such application scenario, there is provided a kind of that ischemic events are subjected to for synergistically alleviating Mammal in reperfusion injury method.The method will during post processing after generally including ischemic events Benefit agent is partly delivered to blood vessel.The cause of ischemic events can be mammal various different vascular systems or Obstruction in microvasculature.For example, specific vascular system can include vascular system, the vascular of dorsal column system of coronary system The vascular system of system, the vascular system of peripheral-system or brain system.After the method for example can be used for alleviating shock Coronary artery lesions, the spinal column after thromboembolism or peripheral damage after cerebral lesion, heart attack, or other include blood supply insufficiency With anoxia in interior disease.

As shown in Figure 1A, show one embodiment of post-processing approach.The foley's tube dress below implemented and describe Put and be incorporated in injury near-end or the position near injury by blood vessel.Sacculus temporarily expansion is with by by blood vessel Blood stops perfusion a certain amount of time, subsequently temporarily shrinks a certain amount of time to allow blood to pass through one section of blood vessel Reperfu- sion Time.For example, post processing operative procedure can be implemented before support is beaten to blood vessel, for example as shown in Figure 1A.As in Figure 1B Shown, post processing can be performed before support is beaten and after beating support.In the case where post processing is performed after support is beaten, Sacculus is preferably expanded and is shunk in mount proximal end, even if sacculus in the tube chamber of support can sequentially expand and shrink.For Schematic purpose, post-processing approach also the United States Patent (USP) of Vinten-Johansen disclose No.2004/0255956 and Described in 2007/0160645, the content disclosed by these patents is by reference to being incorporated herein for all purposes.

Mechanical type post processing is in Reperfu- sion there is provided one or more benefit agent being delivered to ischemic blood vessels and is passed It is sent to the tissue or organ in ischemia downstream（Such as cardiac muscle）Unique opportunity.Benefit agent can be in expansion（Blocking）Or shrink （Do not block）Or blood vessel is directly delivered to during the post processing circulation of the two.So, if Jing intravenous administrations, beneficial system Agent can be with higher than the administration of possible concentration.In addition, in the case of no temporary occlusion, having the benefit agent of concentration in Hou Chu Time of staying when delivering during reason in the blood vessel is more than the time of staying when being delivered by traditional coronary catheter.

In one embodiment, as shown in Figure 18, post processing operative procedure can include the sacculus of circulation in 30 seconds for several times Expansion and contraction, so as to realizing the blood flow of circulation in alternate 30 seconds for several times and not flowing.In addition, post-processing approach and device Benefit agent is delivered during not flow circuit can be included in partly, as shown in the figure.In some embodiments it is possible to for one Secondary or multiple not flow circuit partly applies benefit agent.As shown in Figure 18, one embodiment of the method includes, is lacking Benefit agent is delivered partly during blocking for several times or not each period of flow circuit after blood.However, it is possible in Hou Chu Benefit agent is delivered during both the expansion stage and contraction phase of reason.In this aspect, the benefit agent of delivering will be in expansion It is detained during circulation and flows during circulation is shunk.Local delivery of the benefit agent during post processing is synergistically alleviated again Perfusion injury.

Here is it will be appreciated that various benefit agents can partly be delivered during post processing, scarce so as to synergistically alleviate Reperfusion injury after blood in mammal.It has been found that local delivery of the benefit agent during post processing is significantly Increased absorption of the benefit agent in mammalian tissues.Recognize in order that in the expansion stage of post processing operative procedure, estimating The post processing tissue concentration for going out is C'=（A/V）*K'*Co*Exp-（k+k'）*t'；0<t<T'=Bulking Times.In the contraction phase, The post processing tissue concentration for estimating is considered as C "=（A/V）*K'*C'*Exp-（k'/R）*t"-（A/V）C'*Exp-（k'/ R）*（t-x/V）.On the contrary, operation is considered as C=in the conventional arteria coronaria of no post processing（A/V）*K'C'*Exp-（k'*x/V/ R）f（t-x/V）.Therefore, because the post processing of expansion-contraction is circulated, the benefit agent concentration of tissue is bigger.

" benefit agent " as used herein includes any preparation for promoting health, recover or diagnose.For example, benefit agent Can be medicine, protein or contrast agent.Suitable benefit agent include calpain inhibitor, endothelin receptor antagonists, PH stabilizers, chymase inhibitor, oxygen and oxygen mixture, antithrombotic agents, protein, including the carrier of angiogenesis factor Or cell and biomaterial.The other examples of benefit agent include nitroglycerine, epinephrine, lignocaine, heparin, Hirudin and ReoPro^TM.However, as recognized in the art, other medicines or benefit agent can be adopted.

The non-limiting example of calpain inhibitor include ABT-099, A-965431, A705253, A-705239 or Racemate and its mixture.WO98/25899, WO98/25883, WO9954305, WO99/54310, WO99/61423, WO00/78933, WO2008/080969, WO2009/083581, U.S. Publication No.2006/0205671 and 2008/0097385 In disclose the other examples of calpain inhibitor, content of these patents disclosed by each is by reference to being incorporated herein. Carry out in the patient of artery occlusion Reperfu- sion process cause calcium current enters in myocardial cell, stimulate dependence calcium enzyme calpain. The activation of calpain subsequently results in cytoskeletal protein（That is fodrin）Degraded, so as to increased film fragility.Film fragility with Injection of the fluid in ischemic cell is combined and can cause cellular swelling and death.

In one embodiment, benefit agent is the mixture of calpain inhibitor, dexamethasone and adenosine.Another In individual embodiment, the method includes the sustained release knot of the local delivery by calpain inhibitor during post processing and adenosine Altogether.For example, the support of eluting adenosine or its analog can be disposed in the blood vessel.In certain embodiments, support can be with It is designed to a period of time of eluting adenosine more than one day to three days to reduce faint pulse pipe choking.In other embodiments, support Eluting adenosine or its analog are up to seven days or longer a period of time is to prevent stent thrombosis.Thus, the present invention includes Multiple methods are reducing or alleviate faint pulse pipe choking and stent thrombosis." stent thrombosis " refer to arterial injury and sudden and violent The thrombosiss material of dew, this is sometimes due to placing what support caused.

Suitable endothelin receptor antagonists include ET-A and/or ET-B receptor blocking agents, for example, Astrasentan （ABT-627；A-147627）, ABT-546（A-216546）And its racemate.Filling again in the patient of coronary artery blockage Note is typically resulted in promoting the vasoconstriction of distal end vascular system and/or the release of the angiospastic factor.Some factor bags Include Endothelin, serotonin, 5-hydroxy tryptamine, thromboxane and histamine.The vasoconstriction for causing can cause faint pulse pipe choking（Do not have There is backflow）, the faint pulse pipe choking can continue for a couple of days to several weeks and have been found that the omen for being remodeling ventricle.For example, Recognize in order that there is no myocardium capacity and the patient evolution's left ventricular remodeling for flowing back（The relaxing period capacity of increase）Probability it is direct Correlation, and left ventricular remodeling can cause heart failure.In one embodiment, method includes receiving by local delivery Endothelin Body blocker is alleviating remodeling ventricle.Furthermore it is possible to endothelin receptor antagonists are partly delivered during the Reperfu- sion time with Alleviate faint pulse pipe choking and/or reduce infarct size.Endothelin receptor antagonists can be during blocking period in the ball for blocking Capsule downstream by partly delivering, during blocking period and during reflux period injection catheter downstream injection, optionally Be delivered to by cardiac cycle supply Reperfu- sion tissue or organ tremulous pulse, be optionally delivered to and supply during diastole To Reperfu- sion tissue tremulous pulse to be delivered to endocardium.If it is desire to the delivering of benefit agent to ischemic myocardial is maximum Change, then the Systemic Delivery of benefit agent can be supplemented by arteria coronaria delivering, or the arteria coronaria delivering of benefit agent can pass through quiet Delivering in arteries and veins is supplemented.

In the another aspect of the method, the pH of vascular tissue can be stablized with optimization group after ischemic events Knit vigor.So, it may be desirable to pH stabilizers are partly delivered during post processing.As such, it is possible to make up ischemic damage and reperfusion The common drastically change to blood vessel for the treatment of, and reperfusion injury and infarct size can be reduced.In one embodiment, pH Stabilizer is delivered to blood vessel or blood vessel wall.After reperfusion, the pH stabilizers of delivering can be advanced in wounded tissue simultaneously And control oxygen is delivered to the speed in tissue by blood.As the pH changes in Oxygenation and tissue can be adjusted simultaneously And carry out longer a period of time.

Tissue is allowed little by little to realize that homoiostasiss alleviate the stress on histiocyte and optimize organizational vitality.Should recognize Know, regulation and control can be realized by a variety of causes.For example, therapeutic agent can reduce delivering by replacing the capacity in target tissue The speed of oxygen and therefore prevent oxidized blood（At least in part）Into in tissue.Or, benefit agent can be with blood Oxygen present in liquid interacts to produce chemical by-products, and the chemical by-products can enter tissue and rescue slow therein pH.PH stabilizers for example include the mixture of sodium carbonate and citric acid, carbon dioxide, an oxidation of its generation as side-product The mixture of nitrogen and nitric oxide and carbon dioxide.Each of which has the effect for reducing pH and can control tissue The speed of interior pH changes.Suitable pH stabilizers are included but is not limited to：Sodium carbonate and citric acid；Nitric oxide；Nitric oxide And carbon dioxide, all of which all reduces the endovascular pH of infraction.In one embodiment, expand fluid and benefit agent can Being nitric oxide.Therefore, perfusion balloon catheter can be expanded via the nitric oxide as medium.

In one embodiment, benefit agent can be adenosine and neplanocin.Suitable neplanocin includes：Gland Glycosides Al analeptic, such as CVT-510, BN-063, CPA（N6-cyclopentyladenosine）, CCPA（1chloro N6- cyclopentyladenosine）；With 2 analeptic of adenosine A, such as CGS21680, NECA N-ethylcaroxamide adenosine、2HE-NECA、APEC（2[2-aminoethylaminocarbonylethylphenylethylamino]-5'N ethylcarboxamindoadenosine.Adenosine can be applied to realize the sustained release of benefit agent from FirebirdTM. In one embodiment, FirebirdTM can be with eluting adenosine seven days to about two months to three months.So, adenosine or which is anti-depressant Sustained release can alleviate restenosis, stent thrombosis or faint pulse pipe choking（MVO）.

In one embodiment, method includes：The adenosine of sustained release is applied；During Perinatal Therapy program（peri- procedually）Perfusion calpain inhibitor；Mechanical type post processing is carried out with to ischemic blood vessels, so as to realize what is cooperateed with Or the improvement that volume adds is with the infarct size during reducing reperfusion as treatment.

In a further aspect, benefit agent includes chymase inhibitor.Chymase inhibitor presented below Some non-limiting examples.

In one embodiment, benefit agent is oxygen, nitric oxide and oxygen or activity O₂And oxygen.In this aspect, the party Method is included in and is disposed in endovascular sacculus sequential inflation and Oxygen cycle is delivered to blood vessel and/or infraction portion during shrinking Position.For example, the O of circulation pressurization₂Left main coronary artery, left ventricle, left ventricular wall, right atrium passage can be delivered to.At some In embodiment, it is possible to use artificial O₂Carrier, such as rich in O₂Perfluorocarbon fluid.In another embodiment, artificial O₂Carry The circumfusion of body can be introduced into coronary bed.Normal pressure at aorta sinistra is combined with the negative pressure at venous side will draw Enter rich in O₂Instantaneous flow loop.In certain embodiments, the O of pressurization₂The special tube chamber of conduit can be passed through via nanometer gas Bubble is partly delivered to tremulous pulse.In this aspect, conduit can include suction contact and the release nozzle for pressurizeing.In the circulating cycle In distribution pressurization O₂While contact area can tightly be kept by suction.The O of circulation₂Can be delivered to induce infraction Repair, strengthen fibroblastic growth and/or angiogenesis.

In one embodiment, benefit agent includes zinc chelating agen.Zinc chelating agen can be used for the biological material for strengthening perfusion Material gelinite is crosslinked and gelation on the spot.In another embodiment, zinc chelating agen is the side base of biomaterial.

In one aspect of the method, biomaterial（Such as polaxamers, pluronics, PEG-PLLA and PEG-PLGA bis- Block or triblock copolymer）Can be applied to shield receptor, so as to prevent Zn²⁺Damage infarct size.

Other benefit agents can be including but not limited to：There is stroma cell derivative factor（SDF-1）Donor platelet, pancreas Glucagon-like peptide 1（GLP-1）, bleomycin and/or tetracycline.In this aspect, platelet can be obtained from donor.Blood is little Plate can in the case where there is SDF-1 by electroporation increasing platelet SDF-1 content.Can be little by the blood for processing Jing Plate is partly delivered in the coronary artery of the cardiac muscle of supply infraction treating the destination object for being subjected to myocardial infarction.

In one embodiment, platelet can be by cytokine（Such as solubility kit part, rush thrombocytopoiesis Element）Activation.Recognize in the case where any theory is not held in order that Peng is tied up receiving in infarct area by the platelet of Jing process The surface of damaged arteries will assemble faint pulse pipe choking is being formed in infarct area.Platelet activation in infarct area CFU-GM will be stimulated to recover and sequestering, the CFU-GM will be replaced myocardial cell and/or promote the revascularization of infarct area, change Mercy muscular function and reduce the probability of heart failure.

In one embodiment, benefit agent is biomaterial, when biomaterial is discharged during mechanical type post processing The time of staying in vascular system can be increased.The increase of the time of staying can strengthen from infraction induction injury downstream Mass transportation performance in intravasation, and increase the biomaterial absorption in adjacent tissue.Biomaterial absorbs effect Increase the decay by myocardial remodelling is strengthened.Term " myocardial remodelling " refers to the passive geometry of ventricle experience and/or structure change, Myocardial infarction is followed by generally.Typically, the reconstruct includes the expansion blocked and the expansion of healthy ventricle section, and the phase causes wall to be answered Power increases.

For example can by increase with the increase vehicle viscosity of blood compatible polymer and improve stopping for benefit agent Stay the time.Suitable blood compatible polymer includes hyaluronic acid, polyvinylpyrrolidone（PVP）, poloxamer, Pu Langni Gram, sodium alginate, polyglutamic acid, polyacrylic acid（PAA）, Polyethylene Glycol（PEG）, polyethylene glycol oxide, PEG reaction gels, EDTA- Conjugation polyacrylic acid, silk elastin laminin（Such as protein polymer）, it is poly-（NIPAAM）- PAA copolymers, albumin and poly-（Second Enol）PVA.

The various methods for local delivery benefit agent can be adopted.Weight feed method, formula method for designing and pass Delivery method can be designed to specific function or effect as target.In this aspect, design alternative can affect topical remedy Dynamic metabolism（For example, C_max、T_1/2, AUC etc.）, Blood Kit flow into tissue speed, microcirculation blockage, blood contacting surface Product and contacts blood proximity and active force.For example, can be with selection parameter（Such as benefit agent selection, dosage regimen, formula Design, sacculus expansion/contraction algorithm, balloon features, balloon surface, balloon material and order of delivery）To realize desired result.

Balloon features parameter

For example, balloon features can be designed to avoid contacting with blood vessel wall during expanding.So, local delivery Benefit agent can flow between the surface of sacculus and blood vessel wall, so as to the speed that Blood Kit flows into cardiac muscle will be controlled System.The effect of shape includes：（1）Contact during making blocking is minimized, and（2）To allow flowing（Seepage or wriggling）But do not fill The mode of note regulates and controls flow velocity.In one embodiment, balloon features parameter includes that sacculus has larger curvature degree, i.e., low Ratio of the area to capacity, such as but not limited to spherical balloon.Balloon surface can include that gel coat, surfactant are applied Layer, or be coated to realize desired design parameter（Such as active force of contacts blood and the increase against blood vessel wall）.At this In aspect, can select to be coated with the balloon surface of gel and be provided during delivering benefit agent against blood vessel wall more with designing It is big to contact.

Algorithm parameter

Dilation algorithm can be for example selected from including the algorithm including zigzag, oblique zigzag, rectified sine wave.Determine agent Dose rate for example can be with invariable, monotonic increase or dullness with during shrinking both circulations in the expansion cycles of mechanical type post processing Successively decrease.In one embodiment flow velocity is controlled by, such as flow velocity interrupts, is incrementally increased, little by little interrupt, and then gradually Ground increases.

Benefit agent excipient

The design of benefit agent formula can be the saline excipient containing buffer agent, or alternately, excipient can be wrapped Include viscosity improver, suspension, liposome, micelle, nanoparticle, microsphere or biomaterial.

The delivering of benefit agent can be realized by various methods, such as the injection tube chamber, coating in Reperfu- sion device Sacculus, syringe needle sacculus, perfusion balloon catheter.In one embodiment, Reperfu- sion device is configured with tube chamber, and the tube chamber is suitable to will be had Beneficial preparation is partly delivered to the distal end of the infraction in blood vessel or injury.

Efficacy study

The acute benefits of the percutaneous Ischemia postconditioning after 90 minutes ischemias are induced in the coronary artery of pig are carried out Evaluate.Non- atherosclerosiss pig model is selected, this is because the tremulous pulse of the tremulous pulse of pig and people has as associated class dissecting Structure, FDA's and Schwartz et al. " are used for the pre-clinical assessment of the medicine-FirebirdTM of peripheral applications occasion：From Expert Consensus Group, Circulation, 2004；110：The recommendation of 2498-2505 " is also recommended to use pig model In preclinical study.Animal is with being described with drag：

Species	Pig kind
		Category	Mixing farm pig（Landrace-Yorkshire）
State	Without disease
		Source	Ferme Triporc,Inc.
Pig age	Young adult pig（10 weeks to 16 weeks）
		Weight during implantation	35±10kg
Sex	Sow
		Quantity	39 pigs and 6 standby pigs

Under study for action, animal receives Antiplatelet therapy to prevent or reduce the generation of thrombosiss event.At least exist Animal is allowed to receive oral aspirin daily before three days for being intervened（325mg）And clopidogrel（Predose 300mg is simultaneously And subsequent 75mg）.Before the surgery, make animal calm with midazolam 0.4mg/kg intramuscular injection and 1 minute to 5 minutes it Ketamine 20mg/kg and atropine 0.04mg/kg intramuscular injection is used to apply afterwards.When light anaesthesia is induced, animal by intubation and Supported with force ventilation.By IV, continuously/intermittently row injects propofol 4mg/kg/h and fragrant phthalein Buddhist nun 0.004mg/kg/h（In 5% Portugal In grape sugar juice）Realize anesthesia.Midazolam is applied with the dosage per 15 minutes 0.1mg/kg.Only applied with relatively low amount as needed The anesthesia performed the operation is maintained with isoflurane.

After induction of anesthesia, left or right femoral artery is close to by skin of groin otch.Marcaine is by intramuscular injection Apply to manage perioperative pain.Left coronary artery is proceeded to during guiding catheter is placed on sheath and under guide of fluoroscopy In mouthful.Coronary guide wire is inserted by guiding catheter and proceeds to left anterior descending coronary artery（LAD）In.Sacculus is along before seal wire Enter, till sacculus reaches the distal end of second diagonal branch of LAD.Sacculus is expanded into completely plugged coronal dynamic be enough to The pressure of arteries and veins（1：1：1 size ratio）.LAD is checked to be completely plugged using angiography.Sacculus is made to expand 90 minutes simultaneously And the Reperfu- sion period to animal in two hours observes.

After Reperfu- sion is completed i.e., post processing is performed using the embodiment of system described herein.By making foley's tube Deployed position is proceeded to by guiding catheter on seal wire and device is introduced in coronary artery.Dispose a touch actuator to open Close, and make sacculus prolonged expansion 30 ± 3 seconds.After expansion period, sacculus shrinks, and determines blood by contrast agent injection Pipe is opened（TIMI flowings are evaluated）.During the expansion of 30 ± 3 seconds, the calpain inhibitor of 1mg/kg dosage is applied.In ball Capsule has shunk 30 ± 3 seconds afterwards, and sacculus expands another circulation of 30 seconds.Above-mentioned circulation is repeated, until completing eight second legs 30 seconds expansion/shrink till.Hereafter, delivery apparatus are removed.

With reference to Figure 19, during post processing, the local delivery of calpain inhibitor causes the benefit agent at blocking tissue Tissue resorption is absorbed than the benefit agent at skeletal muscle place and health tissues increases average 40 times.It is beneficial in infarcted myocardium Formulation concentrations are 24.411 μ g/gm, and the benefit agent concentration in skeletal muscle is 0.174 μ g/gm, the beneficial system in health cardiac muscle Agent concentration is 0.457 μ g/gm.It should be understood that the increase of the benefit agent time of staying and distal end are stagnated and generate convection current, from herein Described method result in significantly higher benefit agent and absorb.

Table 1 above is to illustrate the calpain inhibitor detected in the blocking tissue/health tissues of destination object Concentration μ g/gm form.These results astoundingly show the calcium egg in skeletal muscle, blocking tissue and health tissues The absorption of white enzyme inhibitor is increased more than 144 times（Pig 11）, and or even minimum event still increased 4.5 times（Pig 42）.

Figure 20 illustrate post processing perform the operation during, after blood vessel is delivered locally to, 15 minutes time, 30 minutes, 60 Minute, 90 minutes and the chart of the plasma concentration for detecting for 120 minutes.As illustrated, or even two hours after the procedure, The concentration of Plasma Ca protease inhibitor is maintained at 0.0356 μ g/ml levels.Below table 2 is 5 minutes, 10 points time Clock, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes calpain inhibitors in pig vivo detection to blood plasma it is dense The form of degree μ g/ml.As illustrated, the mean concentration of benefit agent reduces over time, but obvious concentration is remained in that, It was 0.615ug/ml at 10 minutes, was 0.318ug/ml at 15 minutes, was 0.145ug/ml at 30 minutes, at 60 minutes When be 0.069ug/ml, at 90 minutes be 0.0469ug/ml, and at 120 minutes be 0.0356ug/ml.

Table 2

Figure 21 illustrates the contrast of the infarct size/risk area ratio between three different sample sets of test：（1） " Control " group, wherein not performing post processing；（2）" AngioPC " group, wherein being performed using traditional angioplasty catheter Post processing；With（3）" PUFF " group, performs post processing operation using in " PUFF " Reperfu- sion system that is embodied herein and describing. The infarct size for each group at seven days and 28 days be the figure shows out relative to risk area（I.e. in infraction Downstream）Ratio.Risk area determines that by T2w-STIR T2w-STIR is to become known for determining the water yield in heart（Edema） Method.

As illustrated, using the post processing of traditional angioplasty catheter and " PUFF " both systems at seven days and two 18 days there is provided significantly more than " Control " group（Post processing is not performed）Advantage." Control " group illustrates infraction chi The ratio of very little/risk area was about 70% at 7 days and was about 58% at 28 days, and AngioPC groups illustrate infarct size/risk The ratio of area is 40% at 7 days about 45%, at 28 days, and PUFF groups illustrate the ratio of infarct size/risk area at 7 days About 53% and be 38% at 28 days.Therefore, compared with the post processing using traditional angioplasty catheter, over time, make The alleviation to reperfusion injury and reduction are improved with the post processing of PUFF systems.

In addition to improved infarct size/risk area, also embodied using the post processing operation of PUFF systems and exceeded The situation of post processing and the improved ejection fraction of the post processing using traditional angioplasty catheter are not carried out.Blood system is penetrated " Number " refers to the blood percentage ratio being pumped out from the ventricle being full of under each heartbeat.Before shrinking in ventricle at once The blood scale of construction is known as end-diastolic volume.Blood volume in the left ventricle at the end of contraction is the end systolic volume.Relax Latter stage capacity and the difference between the end systolic volume are the blood volumes that heartbeat capacity or each heartbeat are projected.Therefore, penetrate blood Fraction is heartbeat capacity divided by end-diastolic volume.Normal LV ejection fractions are 55% to 70%.

Figure 22 be illustrate compared with post processing " Control " group is not performed ischemic events with by traditional blood vessel into The chart of the comparative study result of ejection fraction after the post processing that shape art conduit and PUFF Reperfu- sions conduit are performed.As in chart It is shown, at seven days afterwards, according to use Reperfu- sion system of the present invention（That is " PUFF "）Post processing treatment after destination object exhibition Illustrate to organize with " Control " improved ejection fraction is compared with both " AngioPC " groups.In this aspect, with other other two Individual group is compared, normal ejection fraction of 7 days ejection fractions afterwards closer to 55% to 70%.Additionally, obtained at 28 days When ejection fraction is measured, this improvement compared with " AngioPC " group is maintained and increases really.Any theory is not being held In the case of recognize in order that angioplasty catheter can destroy blood vessel wall and cause ejection fraction to reduce over time, but " PUFF " group surprisingly shows ejection fraction and increases over time.

It should be appreciated that subject matter described herein is not limited to described specific embodiment, and therefore it is of course possible to become Change.It is to be further understood that as the scope of present subject matter is only limited by the appended claims, term used herein Be only used for describe specific embodiment and it is nonrestrictive.When there is provided numerical value scope when, it should be appreciated that the scope it is upper Each intermediate value between limit value and lower limit and any other numerical value being mentioned in mentioned scope or intermediate value It is comprised in disclosed theme.Although being described with reference to exemplary embodiment in detail and indicating the present invention, ability The technical staff in domain will be understood that, can carry out various changes in the case of the spirit without departing from disclosed embodiment, change, Displacement and deletion.It is therefore desirable to the present invention of protection is included within the equivalents in the range of claims below.

Claims

1. a kind of conduit system, including：

Catheter shaft (200) and the sacculus (300) being disposed on the catheter shaft, wherein, the conduit system can be by one People operates, and so as to the expansion of the sacculus is activated within the time less than four seconds, the catheter shaft includes along catheter shaft arranging Expansion tube cavity (203) and independent contraction tube chamber (204)；

Handle (100), the enough hand-held bands of the handle capable of being and including：

Reservoir (101), the reservoir are disposed in the handle, to supply fluid to the catheter shaft and the sacculus,

Actuator (107), the actuator are suitable to the sacculus expansion is allowed when activateding in first position or direction；And

Series of valves (115), which is used to control and adjust expansion fluid by the pulsation and/or regulation and control of the conduit system Flowing,

The control system being arranged in the handle；

Fluid circuit, the fluid circuit include the expansion tube cavity, the independent contraction tube chamber, the control system and described Series of valves,

Wherein, fluid is unidirectional by the flowing of the fluid circuit.

2. conduit system according to claim 1, wherein, the conduit system can make institute within the time less than one second State sacculus expansion.

3. conduit system according to claim 1, wherein, the fluid circuit is also shunk including venturi assist type, its In, the conduit system shrinks within the time less than five seconds the sacculus.

4. conduit system according to claim 1, wherein, the conduit system can make the ball within the time of one second Capsule shrinks.

5. conduit system according to claim 1, wherein, the catheter shaft includes independent tube chamber (206), to deliver One or more of benefit agents.

6. conduit system according to claim 1, wherein, the catheter shaft include from the proximal section of the catheter shaft and (203,204 and 205), and wherein, the tube chamber juxtaposition is forming I-beam for three independent tube chambers that distal section extends Shaped polymer web (208), the I-beam shaped polymer web are laterally aligned with the longitudinal axis of the tube chamber.

7. conduit system according to claim 1, wherein, the sacculus is compliant balloon.

8. conduit system according to claim 7, wherein, the sacculus has enough compliances, to introduce blood The shape of the blood vessel is adapted to when in pipe.

9. conduit system according to claim 1, wherein, the sacculus is spiral or is formed with pit.

10. a kind of conduit system, including：

Catheter shaft (200) and the sacculus (300) being disposed on the catheter shaft,

The reservoir (101) of expansion fluid is contained,

The catheter shaft limits expansion tube cavity (203) and independent contraction tube chamber (204), and ingress port and the port of export Mouth, the expansion tube cavity and the contraction tube chamber are connected by a series of one way stop peturn valves (115), in inflation port and serrated end Unidirectional, independent fluid communication is provided between mouth and the inside of the sacculus, and

Irreversible loading attachment (114), to allow to expand fluid from the reservoir stream to the expansion tube cavity.

11. conduit systems according to claim 10, wherein, the loading attachment be adapted to penetrate through the reservoir with allow by Expansion fluid is discharged in the expansion tube cavity.

12. conduit systems according to claim 11, wherein, the expansion fluid is gaseous material.

13. conduit systems according to claim 10, wherein, the catheter shaft includes pressure indicator (118), the instruction Device is disposed in the sacculus and is shunk between the check-valves that tube chamber is associated with described.

14. conduit systems according to claim 10, wherein, the catheter shaft includes independent tube chamber (206), to pass Send benefit agent to improve the infarct size after ischemic events in destination object.

A kind of 15. systems for implementing Ischemia postconditioning, including：

Conduit (200), the conduit include at least one energy expansion (300), and the conduit is configured for various blood vessels Size, the conduit are configured to receive the seal wire with preliminary dimension, and the conduit with along conduit arrangement Expansion tube cavity (203) and independent contraction tube chamber (204)；

Handle (100), the handle have be entirely located at it is in the handle, for contain expansion fluid reservoir (101)；It is described Reservoir is coupled with the conduit, and at least one energy expansion is arranged to and the reservoir is in fluid communication, and being capable of Jing By expansion tube cavity (203) by expanding fluid expansion for a period of time and can shrink via independent contraction tube chamber (204), its In, the sequential inflation of at least one energy expansion is realized with shrinking by one-touch actuation.

16. systems according to claim 15, the system are configured to treatment system is delivered while post processing is carried out Agent.

17. systems according to claim 16, wherein, the conduit is configured to connect while therapeutic preparation is delivered Receive quick exchange guidewire.

18. systems according to claim 15, wherein, it is described can expansion be constructed having enough compliances with Enable the energy expansion anastomosis of blood vessel shape.