CN101257943B - Balloon catheter - Google Patents
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- CN101257943B CN101257943B CN200680032507.9A CN200680032507A CN101257943B CN 101257943 B CN101257943 B CN 101257943B CN 200680032507 A CN200680032507 A CN 200680032507A CN 101257943 B CN101257943 B CN 101257943B
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- capsule
- outer tube
- pipe
- ductus bursae
- angiopoiesis
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Abstract
The present invention is primarily directed to a balloon catheter system comprising outer and inner conduits, wherein said inner conduit is capable of being moved along its longitudinal axis in relation to said outer conduit. An angioplastic balloon is connected between the distal portions of the two conduits, such that the distal and/or proximal end portions of said balloon is/are capable of intussusception upon proximal movement of said inner conduit in relation to said outer conduit. Finally, the system further comprises means for the introduction of an expansion fluid into the annular space formed between the inner surface of the outer conduit and the outer surface of the inner conduit as well as means for preventing pressure changes within said annular space upon axial movement of said inner conduit in relation to said outer conduit.
Description
Technical field
The present invention relates to a kind of being suitable for reclaims relic and other solid or liquid substance and shifts out the conduit system of described material from health from the health tract.More specifically, the present invention relates to a kind of conduit system, it comprises the pipeline and the inflatable parts that are connected therebetween of two or more arranged concentric, and wherein said inflatable parts are arranged to make it solid or liquid substance can be captured in the interior annular space.
Background technology
Conduit is used for multiple intervention program to send medical treatment device to treatment position (for example, organ or tract for example blood vessel).In a lot of situations, the conduit with little inflatable capsule of far-end is guided to treatment position.In case capsule is in place, the blood vessel that it is in place to be fixed by operator's inflation, block with expansion, to place therapy equipment (for example support) and/or to send operation tool (for example cutter, brill etc.) to the expectation position.In addition, conduit system has also designed and has been used for reclaiming for example object of support from the health tract.
Developed the intravascular conduit of two kinds of fundamental types: by (OTW) (over-the-wire) conduit and the quick conduit of replacing that go between.
The OTW conduit system is characterised in that the appearance of total length lead-in wire, makes that described lead-in wire is by being formed on the whole length of the inner chamber that in the conduit or externally is attached to conduit when conduit during in its operating position.The OTW system has several operability advantages relevant with using the total length lead-in wire, but comprises good rigidity and promotion feature, and described feature is being important when handling ductus bursae along blood vessel complications and/or that part is inaccessible.
US 6,039, and 721 have described a kind of ductus bursae system, and it comprises the pipeline of two arranged concentric, and capsule is connected between its remote area.This conduit system allows the length variations of the expansion of capsule when (in situ) in place/dwindle and capsule, make capsule can extend and intussuscepted configuration between movement.Conduit system is fabricated so that it can be used for two main purposes: at first, different length narrow with single capsule treatment (expansion just) blood vessel, and secondly, delivering stent or medicine are to the vessel inner lesion place, and wherein this support or pharmaceutical pack are contained in the far-end intussusception part of capsule.When being used for a plurality of different length lesion expansion, capsule inserts in the blood vessel to close up the intussuscepted configuration that shortens, and is pushed into up to its arrival and rests in the zone of the shortest lesion to be treated.Thereby capsule is treated (expansion just) then by the inflation lesion.Next capsule dwindles, and the far-end of conduit system moves and makes capsule become to be positioned at the next one to be treated in the zone of short lesion.The effective length of capsule is increased by managing in the near-end pipeline moves then, and next capsule is again by inflation, thereby lesion is treated.By this way, a series of different length stenosis-with from being short to most the single capsule treatment of the longest order-can use.When being used for stent delivery, support is preloaded in as in the formed proximal annular rim of the capsule intussusception result space.Capsule moves to desired locations then and support is sent, and it is by pipe in distally moving (outer tube relatively), thereby " strips off " support from conduit.
WO 00/38776 disclose a kind of basic design class be similar to above-mentioned about US6, the twin flue ductus bursae system in 039,721.This conduit system is intended to vibration mode and uses in order to smash the whole infraction of lumen of vessels.In order to realize this target, outer tube has stiffness variable along its length.In addition, rigidity increases interior Guan Dangqi by the existence of axle tensioned thread during relative flexibility in essence.These pipe design features are used in order to allow the oscillating movement of the near-end of interior pipe is optimally changed into the corresponding vibration of its distal end.
Although a large amount of ductus bursae systems can use now, for can be effectively and the inner chamber of the tract of health internally of safety for example lesion vessels collect the system that deposits speckle fragment and other particle matter and still have demand.
Therefore, main purpose of the present invention provides a kind of ductus bursae system of the risk of the distal embolization of any material that can be expelled the inflation process for the treatment of position that can collect sample and/or fragment from the body treatment position and be reduced in capsule.
Another target provides a kind of like this system, and wherein capsule length can in use not need exceedingly to increase internal pressure and shortens substantially.
A target provides a kind of like this system again, and wherein duct conduits is the structure that is suitable for bearing the power that produces in airbag deployment and folding process.
Another target provides a kind of like this system again, and wherein capsule is that its shape and structure allow debris catching best in tract to be treated and low gabarit to fold.
Other purpose of the present invention and advantage will become obvious along with the carrying out of describing.
Summary of the invention
Therefore, the present invention relates generally to a kind of ductus bursae system, it comprises at least one interior pipe and outer tube that is arranged in another one inside reciprocally, make its longitudinal axis overlap or parallel to each other in fact, manage (far-end-near-end just) axle layout movably along the longitudinal in described, wherein inflatable parts for example capsule be attached between the remote area of described pipeline the remote area of pipe in the far-end of capsule is attached to, and the near-end of capsule is attached to the remote area of described outer tube.It should be noted that term " far-end " is that relative operator limits with " near-end ", just, proximal direction is the direction in operator's direction, and distal direction is the direction that enters the direction of patient body inside away from the operator.Conduit system be fabricated so that interior pipe relative to the lengthwise position of outer tube can be by pipe in moving near-end (just near operator's end) change.By this way, far-end-the proximal length of the outer surface of capsule can be changed, make to cause capsule to be caused between elongation extension configuration and shortening terminal intussuscepted configuration, little by little moving, wherein in the configuration of back, produce open-ended chamber in the terminal intussusception zone of capsule.In use, this inner chamber can be used to not caught specific fragment, liquid and other object and material and safely it be shifted out from the health tract that the ductus bursae system inserts.The inflatable parts that are used for disclosed herein and the conduit system described are to allow described parts to satisfy the shape of dual needs that effective garbage collection and low gabarit send and reclaim.Like this, in a preferred embodiment, inflatable parts arrange with the form that has the conical in shape of being with rounded distal and/or proximal end at its expansion state capsule.The further feature of system disclosed herein is the existence of the device that changes be used to the internal pressure that prevents from occurring as the result of the length that changes capsule and configuration.
Like this, on the one hand, the invention provides a kind of ductus bursae system, it comprises: outer tube; Interior pipe, it is suitable for by lead-in wire, be arranged in the chamber of described outer tube so that pipe comes down to parallel with the longitudinal axis of outer tube in described, and the location is so that the distal end of described interior pipe extends beyond the end of the far-end of described outer tube, and wherein said interior pipe can move relative to described outer tube along its longitudinal axis; The angiopoiesis capsule, its proximal edge is attached to the outer surface of the distal end of described outer tube, and its remote edge is attached to the outer surface of part of the interior pipe of the distal end that extends beyond described outer tube, and the far-end of wherein said capsule and/or near-end can move and intussusception relative to the near-end of described outer tube by pipe in described; Be used for inflation fluid introduce the inner surface that is formed on described outer tube and described between the outer surface of pipe annular space and enter the chamber of described capsule therefrom and be used for its device that shifts out; Prevent the device of the pressure variation of described annular space when being used for the moving axially of described in the relative described outer tube of pipe.
Reaching in the preferred embodiment of the ductus bursae system that limits at this, described system is fabricated so that the distal portions of capsule can move and intussusception relative to the near-end of described outer tube by pipe in described.
In a preferred embodiment of ductus bursae of the present invention system, described in pipe and outer tube be characterised in that it can bear the axial force of the scope between 2 to 20 newton and not produce tangible distortion.In the context of the present invention, term " significantly distortion " vial road length variations surpasses 5% of described pipeline total length.And these pipelines can be made with any material that is fit to that bears above-mentioned power, in a preferred embodiment, interior pipe and outer tube are to be made up by bioavailable polymer (it is selected from the group that comprises the woven nylon line and stood the nylon wire of directional process in a preferred embodiment) or flexible stainless steel pipe.
In a preferred embodiment of the invention, capsule is characterised in that at its inflation state to have the pre-folded gabarit, and just it has and can move help and guide the shape of the intussusception of its far-end and/or proximal part by the near-end of interior pipe relative to outer tube.
In a particularly preferred embodiment of conduit system, aforementioned capsule pre-folded gabarit is to realize by making the conical in shape that this capsule makes its (at its inflation state) have band rounded distal end.
In another preferred embodiment, capsule has the conical in shape of band rounded proximal ends end.
Preferably, capsule is to be made up by nylon, Pevax or its mixture.But, should be realized that capsule also can be by any other suitable material construction well known in the art, it does not exceed claim restricted portion of the present invention.
In a preferred embodiment, the above-mentioned needle tubing shape structure that comprises the near-end that is positioned at conduit system be used to the device that prevents the pressure variation, wherein the tube of needle tubing shape structure is that expansion by outer tube forms, and the plunger of wherein said structure centers on the near-end of interior pipe coaxially and is fixed to the upper.
On the other hand, it is a kind of for the method for collecting fragment from the inside tract of mammalian object that the present invention also provides, and it comprises step:
A) by on lead-in wire, ductus bursae recited above system being inserted described inner tract, and advance described conduit to arrive the position that fragment is collected in expectation up to its distal end;
B) with the described capsule of inflation fluid inflation;
C) spur the interior pipe of described ductus bursae at proximal direction, make far-end and/or the near-end intussusception of described capsule;
D) dwindle described capsule, thereby form the chamber that the inside was collected and captured to fragment; With
E) shift out described ductus bursae with the fragment of catching from the inside tract of described object.
In a preferred embodiment of this place disclosed method, above-mentioned inner tract is vein or tremulous pulse.
Of the present invention above all and other feature and advantage will from the exemplary of its following preferred embodiment and indefiniteness example, be further understood.
Description of drawings
Shown in the figure of accompanying drawing, wherein identical labelling is represented identical parts by example in the present invention, and wherein:
The lead-in wire (over-the-wire) that passes through of the schematically illustrated ductus bursae of the present invention of Figure 1A inserts;
Figure 1B illustrates the cross-sectional side view of ductus bursae of the present invention;
Fig. 1 C is schematically illustrated to be positioned at the embodiment of needle tubing shape pressure compensator of the near-end of conduit system;
Fig. 2 schematically illustrated when in the treatment position inflation ductus bursae of the present invention;
After this Fig. 3 and 4 schematically illustrated capsules by folding inflation also dwindle its garbage collection by ductus bursae enforcement of the present invention; With
Fig. 5 illustrates with comprising that the ductus bursae of the present invention of sample collection gets involved the flow chart of the step of program.
The schematically illustrated four seed capsules design of Fig. 6, it is analyzed in The FEM Analysis and compares: 20 ° of taperings of a. standard; B. 20 ° of taperings that have smooth circular distal; C. circular distal; D. the circular distal that has initial withdrawal;
Fig. 7 illustrates for described four seed capsules shape bit phase shifts diagrammatically for retracting force, and it compares 6 atmospheric inflation pressure;
Fig. 8 illustrates diagrammatically along with capsule is folded in the maximum, force that produces in the conduit tract, and it is measured different capsule inflation pressure.
The specific embodiment
The present invention be devoted in order to from the health tract for example blood vessel shift out object (for example atheromatous plaques fragment) or collect the method and apparatus of sample.This place the methods and apparatus disclosed are except also can be used for expanding the zone (for example the atheroma of blood vessel narrows down or blocks) of health tract from wherein shifting out fragment or other material or object.In a preferred embodiment of the invention, the ductus bursae that is suitable for carrying out common intervention program is suitable for utilizing the unique design of capsule and conduit to make expanding health tract zone and collect object or sample from treatment position.
In the following description, belonging to " conduit " and " pipeline " uses interchangeably.
With reference to Figure 1A, it illustrates ductus bursae 10 of the present invention to for example insertion of health tract 20 for the treatment of position.As shown, ductus bursae 10 comprises the interior pipe 17 that is positioned at outer tube 18 inside slidably.The near-end (tail end just) of interior pipe 17 comprises entrance 12, and it stretches out by the aperture 29 of the near-end that is arranged on outer tube 18.Pipe 17 external surface peripheral in aperture 29 is a tight fit in, do not need clamping it, move with far-end and move thereby manage 17 near-end in when allowing inner chamber when sealed outer pipe 18.Rule 19 optionally is arranged on the outer surface of interior pipe 17.
The near-end of outer tube 18 also comprise for inject/shift out inflation liquid to/from the fluid port 11 of the inner chamber of outer tube 18, in order to export 15 as long as when the overvoltage situation is formed on the inner chamber of outer tube 18, discharge the excess pressure valve of inflation liquid, and the interior pipe safety lock 14 that is suitable for the outer surface of pipe 17 in the clamping, thereby prevent that its near-end-far-end relative to outer tube 18 from moving.
Excess pressure valve outlet 15 can comprise in order to the opening that seals excess pressure valve outlet 15 with in order to need only the excess pressure valve 16 that passes through its discharge section inflation liquid when overpressure condition reaches in outer tube 18 inner chambers.But, should be realized that this overpressure situation can solve by alternate manner.For example, the inflatable piece (not shown) can be attached to the opening of excess pressure valve outlet 15, and can be removed with this executive mode excess pressure valve 16.And, outer tube 18, perhaps its part can be inflatable so that overpressure condition can be solved by its expansion.
In the outer surface of pipe 17 in the seal orifice contact on the outer surface of the near-end of pipe safety lock 14 by being arranged on outer tube 18.Shown in the viewgraph of cross-section of Figure 1B, pipe safety lock 14 was to be clamped in there at the external surface peripheral of interior pipe 17 with interior pipe 17 by pipe safety lock 14 in the inside promotion and the arm that cooperates clamping clip 24 in U-shaped clamping clip 24 can be attached to.
Shown in Figure 1A, the distal openings of the far-end of interior pipe 17 (guide end) by outer tube 18 stretches out and enters health tract 20.Inflatable piece is for example non-complies with the far-end that capsule 5 is attached to outer tube 18 and interior pipe 17.Capsule 5 is preferably made by having the flexible resilient sleeve pipe that reduces the circular cone end of diameter towards the end of sleeve pipe gradually.Capsule 5 is attached to outer surface near the distal end of outer tube 18 at circumference attachment point 7, and is attached to the outer surface of managing 17 distal end in approaching at circumference attachment point 6, makes the distal openings of its sealed outer pipe 18.
Mention as reaching at this, in a preferred embodiment of the present invention, the device that changes for the pressure that prevents the inflation fluid space comprises the needle tubing shape structure that is positioned at the conduit system near-end, the tube of wherein said needle tubing shape structure is that the expansion by outer tube forms, and the plunger of wherein said structure centers on the near-end of interior pipe coaxially.Referring now to Fig. 1 C, the mechanism in the preferred embodiment comprises a part 26 and arranges the plunger 17a that manages 17 outer surface wherein and being attached in movably.The expanding cavity of plunger 17a sealed bladder conduit 10, the near-end that makes its near-end that responds interior pipe 17 move move the suction that produces inflation medium tube entering part 26.
With reference to the flow chart of Fig. 5, it illustrates the step of the intervention program of carrying out with ductus bursae of the present invention.This program starts from step 50, and wherein ductus bursae 10 is guided to treatment position (for example by lead-in wire).Figure 1A illustrates by lead-in wire and inserts, and wherein the insertion of ductus bursae 10 is 13 to carry out by going between.But, should be clear, the present invention is not limited to a kind of specific insertion method and other suitable also feasible insertion method (for example using guiding catheter) also can be used.
Then, in step 51, the operator is by the inflation capsule 5 via the inner chamber of fluid port 11 and outer tube 18 injection inflation liquid, as shown in the liquid inflation arrow 8a among Figure 1A.When carrying out program in the health tract 20 as shown in Fig. 1-4, inflation liquid is preferably injected and is entered capsule 5 so that its circumference side is expanded and is pressed on the inwall 21 of health tract 20, as shown in Figure 2.Capsule 5 pressure inside can be usually at about 1-25 atmospheric pressure in this case, preferably approximately 6 atmospheric pressure.
In this state, wherein ductus bursae 10 is anchored, and the inner chamber of interior pipe 17 can be used to operate with different intervention tool (not shown) at treatment position now, can be as required.Step 52 illustrates the probability of carrying out program if desired, and still, in case capsule 5 reaches its inflation state, some programs (for example angiopoiesis) can be accomplished or approach and finish.
Collect sample or other liquid or solid material for example liquid, secretions and/or fragment 25 from treatment position if in step 53, determine, pipe safety lock 14 is stowed in so in step 54, thereby discharge its clamping from interior pipe 17, shown in the arrow 27a among Fig. 2.In step 55, interior pipe 17 is outwards regained by the operator (near-end ground), and is as shown in arrow 28.In the withdrawal process of interior pipe 17, the distal end of capsule 5 closes up and outer surface part is folded inwards on the distal portions of interior pipe 17 and be folded on himself along with more part of closing up of capsule subsequently, as shown in Figure 3.
In pipe 17 withdrawal and due to capsule 5 inside folds shorten the overall length of capsule 5 of inflation, in fact it reduced the volume of the capsule 5 of inflation.As a result, inflation liquid applied pressure increases, and causes pressure considerable in the inner chamber of capsule 5 and outer tube 18 to raise.As long as the pressure in the inner chamber of capsule 5 and outer tube 18 reaches a certain set point (for example 5-20 atmospheric pressure), inflation liquid is just discharged by excess pressure valve outlet 15, shown in the arrow 8b among Fig. 3, make the pressure of inner chamber of capsule 5 and outer tube 18 remain on predetermined pressure range (for example 5-20 atmospheric pressure).In this step, the operator can determine the amount of the length of the interior pipes 17 regained by rule 19, and determine when by this way to stop to regain and by pipe safety lock 14 in pushing away downwards, shown in arrow 27b, and the stopping of pipe 17 (step 58) in recovering.
Next, in step 56, capsule 5 dwindles by regaining inflation liquid via fluid port 11, shown in the arrow 8c among Fig. 4.As a result, the pressure of the inner chamber of capsule 5 and outer tube 18 reduces in fact, thereby capsule 5 is dwindled.The reducing of the volume of capsule 5 causes forming of inner chamber 40 that the outer surface by folding capsule part limits, as shown in Figure 4.In step 57, ductus bursae 10 is regained on operator's near-end ground makes the liquid/secretions part and the fragment 25 that are limited in the inner chamber 40 be drawn back (not shown in FIG.) by ductus bursae 10.Pipe 17 and the folded part of opening capsule 5 recovered the deflated state (shown in Figure 1A) of capsule 5 and collection easily like this in collected fragment, object or sample can promote by far-end when the whole length of ductus bursae 10 is discharged from the health for the treatment of target.
Consider in being applied in the elongation of capsule and the process that shortens axial stretching, extension and tightening force on pipe and the outer tube, described conduit need be fabricated so that it can bear in the axial force of 2-20 cattle scope and not produce distortion.In order to realize this target, pipeline can or have the material construction that limits molecular orientation by braided material.The maximum, force roughly (for the capsule of two kinds of different size scopes) that interior pipe and outer tube need bear is as follows:
The capsule of-2.5-4mm: conduit need bear big to 500g; Can use the polymeric catheter of being made by the nylon of in manufacturing process, strengthening or pevax.
The capsule of-4-5mm (or bigger): conduit should bear big power to 2kg.Be necessary to use braiding conduit (having the polymeric catheter that the metal twine is strengthened) in this case.
The result of the representative studies of the power that produces in the capsule folding process is shown in the example 2, this and after.
In pipe 17 preferably by the bioavailable polymer types of material for example polyurethane or nylon or PET make, and can utilize traditional method for example to extrude manufacturing.In the diameter of pipe 17 inner chamber usually in the 0.2-2.0mm scope, preferably about 0.5mm, and its whole length is usually at ductus bursae 100-2000mm, preferably about 1500mm.
Although be arranged on the suitable seal that the diameter in aperture 29 of the proximal end of outer tube 18 should be suitable for providing the inner chamber of outer tube 18, in it also should approach on the outer surface of pipe 17 so that interior pipe 17 can be by the there with relative low-frictional force displacement.For example, if the diameter of interior pipe 17 is 0.7mm, the diameter in aperture 29 should be 1.0mm so.
The inventor has been found that the shape of capsule 5 is crucial so that described capsule is finished the expectation function in the conduit system of its and requirement open at this place, just:
I. make by applying minimum may being convenient to fold in the mode of the annulus of the far-end formation expectation of intussusception capsule by retracting force with this;
Ii. present the capsule introducing that to be convenient to dwindle and the low gabarit of extracting conduit system and health tract out.
Like this, the relation between the shape of the material of capsule and design, especially distal end taper and far-end and the near-end taper allows capsule successfully and with relatively little pulling force to fold.This has guaranteed that also capsule will only fold its distal side.
The Modeling Research of carrying out from the inventor shows, when comparing with standard taper capsule or capsule with circular distal, it is preferably and have a relatively little retracting force folding to have a taper capsule of smooth circular distal.In a special preferred embodiment, capsule has and is shaped as near-end taper vertebral body with 15-17 degree angle and the circular vertebral body distal end taper of 15 degree, has the radius at the about 0.5mm in the junction of taper and cervical region.The result of aforementioned Modeling Research is shown in the example 2, this and after.
In the pipe safety lock 14 preferably by bioavailable polymer for example Tecoflex make; Its length is usually in the 1-15mm scope, preferably about 5mm.For example, if the cross-sectional diameter of interior pipe safety lock 14 is about 2mm, be preferably about 2.4mm in order to the suitable sealing of the inner chamber of outer tube 18 is provided by pipe safety lock 14 in it near the aperture of the outer surface that is arranged on outer tube 18 of the inner chamber of outer tube 18 so.
Example
Example 1 is used for the finite element analysis (FEA) of garbage collection capsule of the present invention
FEA is a kind of computerization instrument, and it is used to optimize the design of capsule in order to improve it with the folding ability of the mode of expectation.The capsule of FE model description one inflation, its edge is retracted, thereby causes the folding of capsule.Emulation is carried out under the inflation pressure of different capsule designs and variation, considers the mechanical attributes of capsule material, and this capsule material is chosen for nylon 12 or pebax.
Suppose:
I. capsule is to be made by isotropic material of homogeneity.
Ii. the shape of capsule is vertically axisymmetric about it.
Iii. the shape of capsule is about wherein cross-section axisymmetric.
Iv. fold the bending stress that causes in the capsule material.The mechanical attributes (modular ratio and Poisson's ratio) of the material PE analysis that has been considered into when crooked like this.
Method:
A) this analysis is undertaken by using non linear finite element analysis (FEA) program MSC.MARC.This software allow assessment through be heated or structural load due to structural intergrity and the performance (www.mscsoftware.com) of parts of big distortion.
B) this analysis is non-linear, suppose big displacement and consider to change for how much and thing followed power due to stiffness variation.
C) model is that 2D is axisymmetric.
D) model comprises about 1000 nodes and 1000 2D entity units.
E) from capsule, apply constant pressure at Qi Bishang, thus the reflection inflation pressure.Simultaneously, apply the edge that the axial force that increases gradually arrives capsule, cause it folding.The displacement of cyst wall in level (vertically) axle measured with respect to applied force.
F) longitudinal axis of capsule keeps fixing, and the wall of capsule is by moving freely/fold due to the axial load.
G) specification of capsule is listed in following table:
H) design of four seed capsules is analyzed, and wherein difference is the design (see figure 6) of its tapering:
20 ° of taperings of standard
20 ° of taperings have smooth circular distal
Circular distal
Circular distal has initial withdrawal part.
I) under five kinds of different inflation pressure, carry out emulation: 1,3,6,9 and 12 atmospheric pressure.
The result:
Fig. 7 illustrates for four seed capsules shapes at 6 atmospheric inflation pressure bottom offsets with respect to retracting force.Consider the folding required maximum, force of capsule, taper circular distal capsule needs minimum power, and the circular distal capsule needs maximum power with folding.The tapered distal end capsule is between between them.As if the gradient of tapered distal end capsule compared relative moderate with other capsule structure in the starting stage.Moderate gradient shows higher rigidity.In other words, need higher power to cause given displacement.The gradient of taper circular distal capsule is of steepest, shows high relatively folding compliance.
The relative original shape of capsule collapsed shape also is studied under different inflation pressure (result is not shown).This result shows that comparing the tapered distal end capsule with the circular distal capsule that shrinks with more suitable cunning and continuous mode shrinks hardly.No matter how this fold its required higher force.
Conclusion:
During determining required folding power and folding type, has important function from can the reach a conclusion physical dimension of inflation pressure and capsule of above-mentioned analysis.It shows that the taper capsule that has smooth circular distal when comparing with standard taper capsule or capsule with circular distal folds preferably and has a relative little retracting force.
Example 2 is determined in different inflation pressure for the folding required power of capsule
Equipment and material:
3.0mm nylon 12 Vestamid L2101F capsules (Interface Associates 316079-1)
The grass tube of internal diameter 3mm
Guidant HI-TORQUE CROSS-IT 200XT 0.014 " lead-in wire
Hounsfield Test Equipment Model TX0927, the 50-N load unit
Feasible stretch-draw, compression, shearing, bending and other the mechanical and physical attribute that can determine material of this computer control test set.This device provides the selection of test speed and direct of travel.But its ergometry and shift value, and also can show described test diagrammatically.
Assouline Compressor model 1.5HP
Fluid dispensing system model 1500XL
Step:
Capsule in straight position or 45 ° the position of tilting be inserted into the grass tube of 3mm.Pipe was in order to stablize folding movement in lead-in wire was inserted into.Capsule is by using the compressor inflation, and inflation pressure is controlled by allotter.The scope of program between 3-7 atmospheric pressure carried out, 1 atmospheric increment.Capsule pushes back up to capsule in identical speed then and opens fully to 20mm by pipe in the speed of 100mm/min is dilatory by using Hounsfield Test folding device.
Under each pressure, carry out four tests to determine that the result can be repeated.
The result:
It is shown in Figure 8 to fold the required maximum, force of capsule under each pressure.All increase along with inflation pressure for two positions (straight with oblique) maximum, force, scope is between 2-3.5N (200-350gr), and per 1 atmospheric pressure increment changes between 0.2-0.4N (20-40gr).Higher inflation pressure needs bigger power with folding capsule.This relation is roughly linear (R
2=0.98).Lower a little for the obliquity maximum, force; But the retest in straight position discloses fatigue of materials and causes littler power.In order to support this hypothesis, show that at the visual inspection that repeats the back capsules for 40 times capsule material loses that it is flexible and look like wrinkle.
Above example and describe that yes and only be provided for the purpose of illustrating property, be not to be intended to limit by any way the present invention.The technical staff will recognize that the present invention can implement in multiple mode, adopt from above-described more than a kind of technology, and it does not exceed scope of the present invention all.
Claims (11)
1. ductus bursae system comprises:
A) outer tube;
B) pipe in, it is suitable for by lead-in wire, be arranged in the chamber of described outer tube so that pipe comes down to parallel with the longitudinal axis of outer tube in described, and the location is so that the distal end of described interior pipe extends beyond the end of the far-end of described outer tube, and wherein said interior pipe can move relative to described outer tube along its longitudinal axis;
C) angiopoiesis capsule, its proximal edge is attached to the outer surface of the distal end of described outer tube, and its remote edge is attached to the outer surface of part of the interior pipe of the distal end that extends beyond described outer tube, and the far-end of wherein said angiopoiesis capsule and/or proximal part can move and intussusception relative to the near-end of described outer tube by pipe in described;
D) be used for inflation fluid introduce the inner surface that is formed on described outer tube and described in annular space between the outer surface of pipe and the device that enters the chamber of described angiopoiesis capsule therefrom and be used for inflation fluid is shifted out;
Prevent the device of the pressure variation of described annular space when e) being used for the moving axially of described in the described relatively outer tube of pipe; With
F) excess pressure valve is used for as long as just pass through this excess pressure valve discharge section inflation fluid when overpressure condition reaches in the inner chamber of described outer tube and described angiopoiesis capsule.
2. ductus bursae as claimed in claim 1 system, wherein, the distal portions of described angiopoiesis capsule can move and intussusception relative to the near-end of described outer tube by pipe in described.
3. ductus bursae as claimed in claim 1 system, wherein, described in pipe and outer tube be characterised in that it can bear the axial force of the scope between 2 to 20 newton and not produce tangible distortion.
4. ductus bursae as claimed in claim 3 system, wherein, described in pipe and described outer tube made up by bioavailable polymer.
5. ductus bursae as claimed in claim 4 system, wherein, described bioavailable polymer is selected from the group that comprises braided material or have the material that limits molecular orientation.
6. ductus bursae as claimed in claim 3 system, wherein, described in pipe and described outer tube made up by flexible stainless steel pipe.
7. ductus bursae as claimed in claim 1 system, wherein, described angiopoiesis capsule has the shape that can move the intussusception of its far-end of guiding and/or proximal part by pipe in described relative to the near-end of described outer tube at its inflation state.
8. ductus bursae as claimed in claim 7 system, wherein, described angiopoiesis capsule has the distal taper of band rounded distal end at its inflation state.
9. ductus bursae as claimed in claim 7 system, wherein, described angiopoiesis capsule has the near-end tapering of band rounded proximal ends end at its inflation state.
10. ductus bursae as claimed in claim 1 system, wherein, described angiopoiesis capsule is made up by nylon, Pebax or its mixture.
11. ductus bursae as claimed in claim 1 system is wherein, described be used to preventing that the device that pressure changes from comprising:
Be positioned at the needle tubing shape structure of the near-end of described conduit system, the tube of wherein said needle tubing shape structure is that the expansion by described outer tube forms, and the plunger of wherein said needle tubing shape structure is coaxially around the near-end of described interior pipe and be fixed to the upper.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US69586805P | 2005-07-05 | 2005-07-05 | |
| US60/695,868 | 2005-07-05 | ||
| US72616005P | 2005-10-14 | 2005-10-14 | |
| US60/726,160 | 2005-10-14 | ||
| PCT/IL2006/000770 WO2007004221A1 (en) | 2005-07-05 | 2006-07-03 | Balloon catheter |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210018835.0A Division CN102580227B (en) | 2005-07-05 | 2006-07-03 | Balloon catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101257943A CN101257943A (en) | 2008-09-03 |
| CN101257943B true CN101257943B (en) | 2013-10-09 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200680032507.9A Active CN101257943B (en) | 2005-07-05 | 2006-07-03 | Balloon catheter |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN101257943B (en) |
| ES (1) | ES2352568T3 (en) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8252035B2 (en) * | 2007-08-01 | 2012-08-28 | Cappella, Inc. | Device delivery system with two stage withdrawal |
| JP2013022347A (en) * | 2011-07-25 | 2013-02-04 | Goodman Co Ltd | Method for manufacturing balloon catheter |
| US10639016B2 (en) | 2013-02-01 | 2020-05-05 | Boston Scientific Scimed, Inc. | Methods and devices for Fallopian tube diagnostics |
| BR112015018524A2 (en) | 2013-02-01 | 2017-07-18 | Nvision Medical Corp | process to collect cells from an individual's lumen and catheter |
| CN103479453A (en) * | 2013-10-14 | 2014-01-01 | 黄景陶 | Implantation device for precisely locating human body endoluminal stent |
| CN108738301A (en) * | 2016-02-25 | 2018-11-02 | N视野医学有限公司 | Method and apparatus for fallopian tubal diagnosis |
| CN105919649B (en) * | 2016-06-15 | 2018-03-23 | 汕头大学医学院第一附属医院 | A kind of telescopiform vascular inner body withdrawing device |
| CN111449722B (en) * | 2020-04-08 | 2021-03-30 | 上海心玮医疗科技股份有限公司 | Intravascular delivery system |
| CN112933377B (en) * | 2021-01-21 | 2023-03-28 | 温州医科大学附属第一医院 | Cricopharyngeal muscle dysfunction rehabilitation training device |
| CN113750354B (en) * | 2021-09-08 | 2023-08-22 | 北京清华长庚医院 | Biliary tract internal drainage device with bracket |
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| GB2054385A (en) * | 1979-07-25 | 1981-02-18 | Fogarty T J | Dilatation catheter method and apparatus |
| EP0359489A2 (en) * | 1988-09-15 | 1990-03-21 | Baxter International Inc. | Everting balloon catheter with anchor annulus and balloon for same |
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Also Published As
| Publication number | Publication date |
|---|---|
| ES2352568T3 (en) | 2011-02-21 |
| CN101257943A (en) | 2008-09-03 |
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