CN107261301A - A kind of foley's tube and preparation method thereof and medical treatment device - Google Patents

Abstract

The invention discloses a kind of foley's tube and preparation method thereof and medical treatment device, foley's tube includes conduit, the catheter proximal end side is used for connecting fluid conveying device, distal side is provided with the sacculus connected with the fluid delivery system, the sacculus includes distal portions, proximal part and the waist between distal portions and proximal part, and the maximum gauge of the waist is less than the maximum gauge of distal portions and proximal part.Foley's tube of the present invention, it can be used for the aortic stenosis or birth defect and/or impaired leaflet for treating Calcified, the distal structure of its taper can preferably be fixed on left ventricular outflow tract, and the physiological make-up at aorta petal position is also more conformed to for its features of shape.

Description

A kind of foley's tube and preparation method thereof and medical treatment device

Technical field

The present invention relates to interventional operation equipment field, more particularly to a kind of foley's tube.

Background technology

Calcific aortic stenosis is falling ill and dead common cause for the valvulopathy day after tomorrow.The hair of gerontal patient Sick rate is exponentially increased.Over time, the fibrosis of valve and calcification can be serious all the more, limit its opening and closing ability.After And blood flow is hindered, cause other various clinical syndromes, such as heart failure.Deformation and narrow aortic valve disease The other reasonses of change include rheumatic heart disease, and congenital heart disease.Valve lesion that rheumatic heart triggers is serious Words need to treat by aortic valve replacement.

In the prior art, the treatment for calcific aortic stenosis can use foley's tube, in use, receive The valve site that the foley's tube of contracting state needs to treat through vein or artery insertion positioning, is then filled with by gas or liquid Foley's tube so that balloon catheter expansion, struts the valve orifice of lesion, the diaphragm of calcification is expanded and is bent, certain Recover the unidirectional of its blood flow in degree to pass through.Balloon dilatation, can enable the valve of calcification recover flexible bending, by adjacent membranes Being adhered for piece is partially separated, and is completed foley's tube after expansion and is withdrawn from again from vivo.

In the prior art, foley's tube typically has the predetermined shape of fixed diameter, is made by being filled with fluid raising pressure It is expanded to predetermined shape by compressive state, applies the extruding force of expansion to valve.

Using the foley's tube (referring mainly to its inflatable position) of non-elastic material, reach after predetermined shape, even if fluid Pressure increase, the diameter change of foley's tube also very little, it is possible to achieve effective treatment at elevated pressures, but non-resilient material Its predetermined shape of the foley's tube of material is possible to change during manufacture or collapsible, prepares to withdraw after expanding in addition When, it is also difficult to recover due compactness, larger vessel catheter sheath therefore, when recalling is needed, so as to add wound Risk, the foley's tube of non-elastic material has the transition region of taper, the transition between larger external diameter position and centre pipe axle Area has larger wall thickness and hardness, and its compliance is poor, also increases the risk of injury of blood vessel, it is difficult to by tortuous Blood vessel is promoted.

Radial dimension is changed greatly when being used due to foley's tube, therefore can also use the material with higher elasticity, Such as latex, but still with significant limitation.The diameter of elastomeric material can constantly increase with pressure, and its maximum gauge does not have There is the limitation of inherence, but more than its elastic limit foley's tube rupture may be caused to injure patient, diameter becomes too big, it is also possible to Cause tear leaflet and contiguous teaming arrangement.

By taking aorta petal position as an example, left ventricle is stretched into distal end when foley's tube is used, and proximal end is in sustainer, middle part Across aortic valvular ring, foley's tube is substantially cylindrical or ellipsoid, is difficult to position under the impact of heartbeat and blood flow, Axile displacement is likely to occur, for example, slides into and stabs left ventricle.

In addition, valve site can be closed after existing balloon catheter expansion, blood flow is hindered, low blood pressure or correlation is caused simultaneously Send out the risk of disease.

Existing foley's tube applies after expansion to aortic valve, and the flexibility of the opening and closing of leaflet still has deficiency, especially For severe fibrosis and the valve of calcification, because the expansion diameter of foley's tube is limited to annulus, it is difficult to meet in sustainer Expanded dimension needed for sinus position, if increase foley's tube diameter can tear aortic valvular ring on the contrary simply, therefore for leaflet Expansion effect it is unsatisfactory.

The content of the invention

The present invention provides a kind of foley's tube, can be used for the aortic stenosis or birth defect for treating Calcified And/or impaired leaflet, the distal structure of its taper can preferably be fixed on left ventricular outflow tract, for its features of shape Also the physiological make-up at aorta petal position is more conformed to.

Foley's tube of the present invention can more be accurately controlled deformation with aortic valvular ring of fitting, and prevent that excessively expansion is caused Annulus damage or tear.

Foley's tube of the present invention may be also used in the narrow of human body other tubular structures, tubular structure such as body it is any Blood vessel, including coronary artery, peripheral arterial, vein, esophagus, tracheae, intestines blood vessel, bile duct, ureter etc..Foley's tube of the present invention It can also be used for being expanded in advance before lesions position displacement or the other prosthetic appliances being implanted into, by changing or changing bigger Or the sacculus of smaller diameter, for the artery of human body, vein in body orifice or other hollow organs, and can measure deformation in real time Degree, generally better than existing standard cylindrical valvoplasty sacculus.

A kind of foley's tube of the present invention, including conduit, the catheter proximal end side are used for connecting fluid conveying device, and distal side is set There is the sacculus connected with the fluid delivery system, the sacculus includes distal portions, proximal part and positioned at distal portions Waist between proximal part, the maximum gauge of the waist is less than the maximum gauge of distal portions and proximal part.

The flexible area of sacculus and inelastic region, when sacculus expands, inelastic region is expanded to most prior to elastic region Major diameter.The waist is elastic region, and the distal portions and proximal part are inelastic region.

It is of the present invention it is elastic, non-resilient be that comparatively, not both be strict with the absolute figure of its performance.Example Such as with ball intraluminal pressure increase inelastic region deformed dilation first to its pre-setting maximum gauge, and elastic region continue increase Just can further it be expanded during plus-pressure, i.e., inelastic region is expanded to after being expanded to the maximum gauge state of itself, elastic region first The maximum gauge state of itself.

Optionally, the distal portions expand before proximal part or expanded simultaneously with proximal part.Utilize material Difference can control the expansion order of different parts under the pressure of fluid.

Optionally, the bulbs of pressure of the distal portions, proximal part and waist expander to itself maximum gauge are each not It is identical, or distal portions are identical with the bulbs of pressure of proximal part, and the bulbs of pressure of waist are more than distal portions and close end The bulbs of pressure divided.

Optionally, it is the dumb-bell shape of big at both ends and small in middle after the sacculus is expanded to maximum gauge at each position.

Exemplified by being placed at aorta petal, dumb-bell shape has center self-positioning and neighbouring on every side of aortic annulus The waist of annulus, proximal part is contacted with the leaflet of aorta petal so that the expansion of sacculus by leaflet outwardly against aortic sinus, Further such that leaflet is split or ruptured at or near the base portion of proximal part, and with the standard cylindrical than prior art Bigger the extending radially outwardly of sacculus offer.Distal portions in left ventricular outflow tract (LVOT) help to prevent sacculus Due to from the blood pressure that beating heart is produced and migrated downstream during inflating.

Lumbar region is used for the diameter for more accurately measuring annulus, is additionally operable to measure the compliance feature of annulus, so as to help Help the execution valve expansion program that doctor is safer to patient's annulus structure.

Oval annulus has error using standard echo sounding, makes undersized, the of the invention bullet of the diameter of measurement Property waist can be good at fit annulus, readjust its shape, and then diameter is more accurately measured.

Proximal part and the subregional size of distal portion are set to and completely attached to respectively with leaflet and LVOT that sacculus is initially swollen Swollen to pass through annulus, proximal part and distal portions tend to distribution to every side of annulus, as fluid is further injected Into sacculus, balloon interior pressure increase, the diameter of waist also further increases.When inner balloon pressure reaches about 2atm, The leaflet of most patients outwards pushes aortic sinus to by near-end.Under about 2atm pressure, distal portions reside in annulus Upstream LVOT in.

Sacculus is further injected fluid into, waist further expands and contacted with annulus, fluid means is filled by measurement The fluid volume being injected into sacculus can be continuously monitored, and passes through the inside of the pressure sensor monitoring sacculus in sacculus Pressure, obtains the relation curve between Volume Changes and Pressure rise rates.

Optionally, the overall internal layer of the sacculus including elastomeric material and distal portions and proximal part are wrapped in Portion outer layer, portion outer layer is non-elastic material.Preferably, being provided with waist prevents the axially extending supporter of waist.

Optionally, the inside of the sacculus is additionally provided with interior sacculus.Interior sacculus can be very good to play a part of being pre-positioned.

Optionally, the sacculus is circumferentially arranged by multiple bulbec capsules and formed, independent sealed between bulbec capsule.For example with The position that can be contacted between five sub- sacculus, adjacent bulbec capsule along them is bonded to each other.Fluid is defeated by the manifold of proximal lateral Deliver in each in five sub- sacculus, and the distal side of each bulbec capsule is closed.The central area of five sub- sacculus Passage for providing blood flow.The inside of general aorta petal can obtain about 0.4 square centimeter of blood perfusion face.

Optionally, the external capsule wrapped up in the periphery of institute's sub-ball capsule.For further five sub- sacculus to be engaged with each other or Keep together, and spacer region can be also produced between external capsule and five sub- sacculus, for blood flow, outer capsule inner wall can be consolidated Surely each in five sub- sacculus is connected to, stability is provided for whole perfusion balloon catheter structure.

Optionally, the distal portions, proximal part and waist for each independent bulbec capsule or at least adjacent two Person is structure as a whole.The corresponding conduit, which is provided with, is used for the company that distal end portion, proximal part and waist are filled with fluid Through hole, intercommunicating pore have three it is corresponding with distal portions, proximal part and waist respectively or have two, distal portion is corresponded to respectively Point, proximal part, waist and distal portions are structure as a whole and share an intercommunicating pore.

Distal end of the present invention and near-end refer to stretch into left ventricle runner in sustainer side, if being stretched from apex of the heart side Enter, then distal end and near-end are just the opposite, but reason is similar, can refer to understanding or be considered as equivalent.

Optionally, the distal end of the conduit is provided with tailfiber, and tailfiber can be that hollow-core construction extends to proximal lateral to measure Pressure pours into medicine.

Optionally, the conduit is provided with filter.Thrombus or other solid contents can be arrested, prevent from flowing into sustainer.

Optionally, the periphery of the sacculus is provided with limitting casing, can limit the maximum gauge of sacculus and place skew, limit Position frame includes the spoke of more than three and two mounting rings of each spoke end of connection, and mounting ring is enclosed on conduit and positioned at ball The axial both sides of capsule.

Optionally in order to detect and track procedure, label is set on sacculus and/or conduit.Utilize radiography hand Section can know balloon position and degrees of expansion.

Optionally, the conduit is in the eccentric position of sacculus, and the channel of blood flow of insertion is provided with the axis part of sacculus. Sacculus can be avoided to block the thrombosis that annulus position is caused for a long time.

Preferably, the channel of blood flow is provided with check valve.It can prevent from backflowing to a certain extent.

Optionally, the conduit is in the axis position of sacculus, and channel of blood flow is set in the eccentric part of sacculus.Channel of blood flow It can set multiple, be interconnected each other or independent.

Channel of blood flow be able to be set with sacculus axis relative tilt with sacculus diameter parallel, i.e., inclined insertion Sacculus.

Due to being narrowed waist in the middle part of sacculus, the channel of blood flow can also be only insertion distal portions, distal portion Divide or the shape of cross section of proximal part can be circular, can also be other shapes, can be considered in circular outer rim there is part Cave in, caving in, position can then also serve as channel of blood flow, can be entered to keep caving in the periphery of sacculus using tightening part The spacing and shaping of row, coating is set in the periphery of sacculus, and between coating inwall and region of caving in is channel of blood flow.

Distal portions have primarily served the grappling effect for stretching into left ventricle runner, therefore its shape can have other changes, Such as anchor, the consumption of fluid when can also reduce expansion.

The spacing valve of wire frame structure is provided with optionally on the conduit, spacing valve can have multiple, be evenly distributed on swollen The periphery of proximal part after swollen.

Leaflet is resisted against on spacing valve when being expanded outwardly by the extruding of proximal part, can also be set on spacing valve Multiple block pieces are put, under block piece effect many places bending occurs for leaflet, and its compliance, which is had, further to be improved.

In order to further improve locating effect, anchor log is provided with conduit, the anchor log is located at the distal end side of sacculus, Further stretch into left ventricular outflow tract.

The present invention also provides a kind of preparation method of the foley's tube, includes the elastomeric layer of formation balloon features, In the periphery of elastomeric layer and part formation inelastic layer corresponding with distal portions and proximal part.

The present invention also provides a kind of preparation method of the foley's tube, including forms the non-elastic material of balloon features Layer, in the periphery of inelastic layer and the waist for being partly modified, obtaining elasticity corresponding with waist.

The present invention also provides a kind of medical treatment device, including the foley's tube and for transporting fluid into foley's tube Driving equipment, the driving equipment detects the pressure of fluid, and obtains according to pressure change the waist of sacculus in foley's tube Diameter.

During typical valvoplasty is operated, the foley's tube of the present invention is inserted into the intravascular of patient and is advanced to Narrow pending valve, the aortic valve for example abutted with the left ventricle of heart.Once the desired locations in valve, Foley's tube is inflated with liquid contrast media, and dilating sacculus forces valve leaflet (leaflet) to be opened.Beaten by the leaflet of short duration time Open, leaflet a certain degree of can recover its original flexible and corresponding cardiovascular function.

Brief description of the drawings

Fig. 1 is the structural representation of foley's tube of the present invention；

Fig. 2 is the schematic diagram that distal portions expand；

Fig. 3 is the schematic diagram of proximal part preexpanding；

Fig. 4 is the schematic diagram after sacculus bulk expansion；

Fig. 5 is sacculus bulbs of pressure change curve schematic diagram；

Fig. 6 is the schematic diagram that sensor is set on sacculus；

Fig. 7 is the driving equipment structural representation for transporting fluid into sacculus；

Fig. 8 is sacculus forming process schematic diagram；

Fig. 9 is the structural representation for adding capsula interna；

Figure 10 is the distribution schematic diagram of bulbec capsule；

Figure 11 is the structural representation of setting blood flow catheter in bulbec capsule；

Figure 12 is the schematic cross-section of sub- balloon structure；

Figure 13 is the schematic diagram that bulbec capsule is interconnected；

Figure 14 is to utilize the enhanced sacculus schematic diagram of fabric；

Figure 15 is the schematic diagram after Figure 14 balloon distal expansion；

Figure 16 is the schematic diagram after Figure 15 balloon proximal expansion；

Figure 17 is the structural representation that sacculus periphery is provided with beam ring；

Figure 18 is the schematic diagram that sacculus axis position sets channel of blood flow；

Figure 19 is the schematic diagram that sacculus periphery sets channel of blood flow；

Figure 20 is the schematic diagram that two sacculus are arranged side by side；

Figure 21 is the schematic diagram that sacculus periphery sets spacing valve；

Figure 22 is the structural representation of spacing valve；

Figure 23 is the schematic diagram that sacculus periphery sets band；

Figure 24 is the schematic diagram that sacculus sets inclined channel of blood flow；

Figure 25 is the structural representation that balloon distal side sets anchor disk.

Embodiment

By taking the physiological structure at aortic valve as an example, referring to Fig. 1~Fig. 4, the elongated conduit 1 of foley's tube of the present invention, The outside of conduit 1 is sacculus 2, and sacculus is divided into proximal part 3 corresponding with aortic sinus position, and is anchored on left ventricular outflow tract (LVOT) distal portions 4, are narrowed waist 5 between proximal part 3 and distal portions 4, the waist 5 after positioning and active The position of arteries and veins annulus is corresponding.

At aortic valve, near-end side is the aortic sinus 6 expanded, has leaflet 7 in it, is annulus 8 at most narrow place, It is again then left ventricular outflow tract 9 toward upstream.Distal portions 4 are anchored on left ventricular outflow tract, and proximal part 3 extrudes annulus after expanding 8 towards bending is reclined at the inwall of aortic sinus 6 to reply certain compliance.

The multiple independent passages that can be set in conduit 1, each passage and is extended in the proximal end opening of conduit The distal end of conduit, is arranged as required to be open or close, conduit has at least three passage in the present embodiment：First passage 1a For connecting seal wire, second channel 1b is used to inflation fluid being passed through proximal part 3 via the intercommunicating pore 10 on duct wall, the Triple channel 1c is used to inflation fluid being passed through the He of proximal part 3 in distal portions 4, Fig. 1 via the intercommunicating pore 11 on duct wall It is that both accordingly match the proximal part having in intercommunicating pore, Fig. 2~Fig. 4 on two each independent capsules, conduit that distal portions 4, which are, 3 and distal portions 4 be then connected as a single entity structure.

The pressure and cubing equipment of outside can be connected by second channel 1b and third channel 1c, to monitor and survey Measure the state of sacculus.

Developing mark 12 is positioned at each supravasal position, to mark the border of proximal part and distal portions, is shown Shadow mark 12, which can be set, distal end, near-end and the middle part for being located at sacculus at 3 respectively in many places, such as Fig. 1.

The tailfiber 13 of curling is located at the distal end of conduit, prevents catheter tip to the mechanical damage of patient, tailfiber 13 can be set Hollow-core construction is set to, its end or side cornice there are some through holes to carry out pressure measxurement or injection developer solution etc..

The foley's tube of prior art may cause the mechanical damage of heart when using, particularly attached at the top of left ventricle Closely, for example in the presence of blood flow, the sacculus of expansion moves back and forth by and contacts aorta petal, and the foley's tube of the present invention Distal portions preferably there is back taper, the diameter close to distal side will be bigger, and by this way, distal portions can more meet LVOT anatomical structure, prevents from moving back and forth suddenly.Certain distal portions can be shaped as different forms, and the purpose is to again More closely engagement LVOT is used for axial restraint.

Distal portions expand under low the blowing pressure, for example, less than about 3atm.Distal portions axial length is about 15- 20mm, a diameter of 24-28mm, proximal end portion diameter is preferably 20-24mm, can be become certainly according to patient anatomies Change so that the size and dimension of distal portions is more closely fitted LVOT.

The periphery of proximal part is circle in Fig. 1 so that leaflet can as broadly as possible be opened and is stretched in aortic sinus, Also bigger valve orifice can be produced, proximal part can obtain about 24mm ball in about 4atm pressure at maximum gauge Footpath, and about 28mm balloon diameter is realized under 6atm pressure, because whole sacculus is two independent capsule knots in Fig. 1 Structure, the axial length about 18mm close to end side, maximum gauge is about 24-30mm.

With reference to Fig. 2~Fig. 4, in operation, placed by femoral artery or arteria brachialis after seal wire, by the foley's tube of the present invention Advance along seal wire, until tailfiber is stretched into and is positioned in left ventricle.

During can combine x-ray fluoroscopy method, be inflated when distal portions are positioned in LVOT using the fluid containing contrast agent Sacculus, proximal part and distal portions first expand until reaching due to the elastic poor or non-elastic material of material, therefore diameter To the maximum gauge state of pre-setting, it is preferred that distal portions can be caused by the separation of material physical properties and sacculus Expansion earlier is simultaneously pressed against LVOT inwalls, and locating effect can be further enhanced in the axial direction, after distal portions positioning, is re-filled with Fluid causes proximal part to expand.

After proximal part and distal portions complete expansion, if further improving pressure, waist is due to using elasticity Material, at least elasticity are better than proximal part and distal portions, cause waist further to be risen and increase diameter, in this process In, the proximal part or waist of different-diameter can be obtained by changing pressure, to realize the flexibility for improving leaflet, and it is therefore real The current gradient for hoping blood stream pressure reduces.In order to ensure having been carried out these targets, distal end can be used after sacculus is recalled Guidewire lumen measures the pressure of aortic valve position, and tailfiber is stayed in LVOT, and pressure biography is connected at the corresponding passage of near-end Sensor, while measuring the pressure of sustainer and left ventricle.

Filter can be set on conduit, the filter is in umbrella shape and is fixed near the proximal part of sacculus, to capture operation The fragment that process is produced, prevents the embolic complications of patient.Filter is made up of the pole of multiple radial distributions, each pole it is remote Against the inwall of aorta ascendens after the expansion of end, the shroud-like structure of closing is formed.

In operation, filter is in sheath in compressive state first, and now each pole, which is pressed against, is covered in conduit Periphery, when user deploys filter in desired position, sheath is proximally retracted, and exposes filter, and each pole can be extensive Multiple pre-setting state is to extend out that the chip in surgical procedure can be intercepted for umbrella shape and against aorta wall, it is necessary to court when removing filter Distal direction pushes sheath, then pole compresses the conduit and together with conduit retraction sheath of reclining once again.The material of filter can be adopted With prior art, such as some memorial alloys.

The outer surface of sacculus can coat silicone oil or hydrophilic coating, can strengthen the center oriented of sacculus as smoothing preparation, And or the outer surface of a part for sacculus can be veining or coarse, help that sacculus is maintained at into suitable after inflation Work as position.

The outer surface of sacculus can also be coated with the medicine for elution.It is, for example, possible to use Olympic department or Japanese yew alcohol type Medicine or other types of medicine offset the local deposits of calcium, and may change the doped calcium of Gegenbaur's cell.

Can be by monitoring change of the change relative to balloon volume of the pressure in sacculus, or fluid injection sacculus Volumetric rate relative to the time change, to determine when waist reaches annulus.

Referring to Fig. 5, fluid volume is so that in constant rate of speed injection sacculus, the pressure in sacculus is (also visual with injection with the time Fluid volume) variation relation.

When sacculus initial bubble, proximal part and distal portions expansion, and waist expander balanced to it, i.e. low pressure shape State.

Because proximal part and distal portions are made up of non-elastic material, when unconstrained sacculus begins to fill with fluid, Volume also expands therewith, therefore pressure is not high and change is slow, i.e., the A sections in corresponding diagram 5.

When proximal part and distal portions reach the limit of its non-elastomeric expansion, the pressure in sacculus starts increase, right The B sections in Fig. 5 are answered, cause waist expander to be balanced more than it, during the further expansion of waist, pressure change generally follows waist The elasticity and compliance of portion's material, which determine B sections of gradient, until waist contacts annulus, now can significantly limit waist Further expansion.Therefore, pressure can produce flex point C and cause the D sections in the obvious increase of slope, i.e. corresponding diagram 5 in sacculus, D sections of ends in order to prevent from pressure from crossing rising sharply brokenly sacculus can tear annulus, pressure can be maintained by limiting mechanism of pressure pressure release Certain level.The absolute volume of sacculus can be controlled and be monitored by constant volume pump.

When more than flex point C, the pressure of waist change is applied to annulus, and D sections of slope also indicates that whether annulus is softer Or whether calcification, operator can assess the effective modulus of annulus by observing the slope of the pressure curve above flex point.

During flex point C, waist may contact annulus, can be at this moment by determining sacculus at various pressures before operation Waist sizes, are then directly viewable the pressure reading of flex point to estimate the size of waist during operation.

Preferably, computer and computer software (for example, special pressure display device or PC) can be used with curve map Form record and display pressure.User can manually determine flex point and it is thus determined that the chi of anchor ring with monitor curve figure It is very little.Or, computer software can monitor pressure data (for example, slope) and automatically determine flex point and the pressure value is converted into waist The diameter dimension in portion.

Referring to Fig. 6, parts numbers can be found in Fig. 1~4, in order to measure annulus size, can set sensor 14 in waist, pass Sensor 14 can be the resistance material around waist or part lumbar region, in stretching waist, and the resistance of material changes, and It can be detected according to the circuit of resistance variations.Sensor 14 can also be located at least one of piezoelectric of waist, make Proper piezoelectric can produce electric signal when being forced to be stretched to different degrees of, sensor 14 passes through leading for being positioned along balloon shaft Line 16 is connected with external circuit.

Sensor 14 can also be the sensor of Capacitance Coupled arranged in pairs or inductive, and it detects a sensor With the degree of approach of another sensor, and the change at the interval between two such sensors can be recognized.

Sonac 15 can also be set, the diameter for measuring the waist when waist contacts annulus.Sonac 15 are arranged on balloon interior, measure and indicate the diameter of annulus by sonac 15 during flex point C, and it can also be recognized The girth of annulus, and the information can be converted into annulus diameter.

Preferably, proximal part is dimensioned slightly smaller than aortic sinus, and proximal part root (it is close to waist location) can be valve Leaf provides bigger expansion, and the standard cylindrical balloon compared to prior art can more effectively rupture doped calcium thing, soften valve Leaf.

Sacculus and its relation for being filled with fluid volume and waist diameter is measured in advance, in flex point C according to the volume of fluid Waist diameter can be learnt.

Fig. 7 shows that the present invention is used for the driving equipment for transporting fluid into sacculus, the compressible drive plunger 18 of handle 17 Along cylinder 19 downwards, to force contrast solution (fluid) to enter sacculus, locating part 20 is used for the extreme position for limiting plunger 18.

In the first stage, fluid is flowed out with faster rate from outflow port 21, with about 1-5 seconds about 90% ball Capsule volume is filled.

In second stage, remaining about 1-2cc fluids are flowed out by the side opening 22 in bottom plunger.

Need from sacculus removing fluids when, start toggle switch 23 with allow handle 17 lift plunger upwards, fluid passes through Check valve 24 flows back and is ready to transport fluid into sacculus next time.

Relative quantity (or the volume that the fluid that variable resistance 25 can be used as fluid volume measurement to track into sacculus is conveyed Change).Sensor 26 also can be used to detect change of fluid positioned at the side-walls of cylinder 19, and the outer wall of cylinder 19 can be set display to show The signal such as volume or flow, can set pressure sensor, and pass through display reading in sacculus and cylinder 19.

The variation relation and relation curve of pressure flow can be calculated using computer or chip, when reach flex point or tiltedly When rate changes, capture and shown together with corresponding balloon diameter at this pressure.

Driving equipment can also make fluid be transported to foley's tube with the speed of constant, in this case, calculate Machine will receive pressure data and store itself and the elapsed time from starting to inject a fluid into sacculus.In this case, will Pressure and the relation of time are drawn, and calculates the slope of a curve and detects the change of the slope.When Pressure versus Time curve When slope reaches flex point, pressure at the point is by computer capture and is converted to waist diameter and is shown.

In sacculus manufacturing process, the elastomeric material (SC) used can be selected from nylon, Surlyn, vinyl, PVC, poly- second The copolymer of alkene, polyurethane, Pebax, alkene or these materials.

Non-elastic material (NC) can be selected from PET (Dacron), Teflon, polyimides, Kevlar wrappages, metal, Polymer or fibrous material.

By applying crosslinking such as electron beam, non-ballistic can be made in chemical or other crosslinking Treatments, elasticity or semi-elastic material Property material.Non-elastic material can by using electron beam, be chemically treated or other PROCESS FOR TREATMENTs so that molecular structure die down and More elastic or semi-elastic material is made.

As shown in figure 8, can be produced by extruding the first pipe 28 of elastomeric material and the second pipe 29 of non-elastic material Sacculus, the second pipe 29 is two sections, and proximal part and distal portions are corresponded to respectively, and the first pipe 28 of waist exposes.By the first pipe 28 and second pipe 29 be put into the mould 27 for the heating to form balloon features, while apply tube assembly inside pressure with keep with The contact of mold profile, can apply adhesive or thin polymeric layers (preferably in molding work between the first pipe 28 and the second pipe 29 Before skill) to strengthen mutual bonding.

In addition, the fiber of axial orientation can adhere to or be embedded in lumbar region, to help the axial deformation for reducing waist. The fiber of axial orientation can be the single polymer or metal strands or multifibres strand in the outside for being adhered to lumbar region, or Person is clipped between two layers of balloon material (the first pipe 28 and the second pipe 29).

In another embodiment, the second pipe 29 can be whole piece, in proximal part, and waist and distal portions cover first The second pipe 29 is used into laser-induced thermal etching or plasma etching in waist after pipe 28, the first pipe 28 and the mutually bonding of the second pipe 29. Machinery etching or chemical etching can be used.Then required balloon features are formed in the mould of heating.Can also be first sharp With mould molding, then waist is performed etching again.

In another embodiment, the second pipe 29 for being pointed to lumbar region processes pressure in axial slits, such waist During increase, it is allowed to realize enlarged-diameter.

In another embodiment, desired balloon features are molded as by elastomeric material first, mask covering are applied in waist, Unmasked region, i.e. distal portions and proximal part coating it is thin and elastic polymer nitride layer, can include polyimides, Polyethylene terephthalate, fiber-reinforced polymer and many polymer for being generally used for non-resilient sacculus.It is non-resilient poly- Compound can be applied by spraying or dip-coating, and can further handle non-resilient to strengthen to provide crosslinking.

In another embodiment, desired balloon features are molded as by non-elastic material first, next passed through in waist Electron beam, chemical treatment or mechanical treatment, reduce the crosslinking in polymeric material, therefore can increase processing region by processing Elasticity, makes the mechanical property of waist meet expection.

In another embodiment, desired balloon features are molded as by elastomeric material first, next apply in waist and cover Mould is covered, and is handled in unmasked region, i.e. distal portions and proximal part, such as in most of hydrocarbon main chains (such as poly- second Alkene) between cause the electron beam of crosslinking, can be non-resilient by unmasked regioinvertions.

In another embodiment, sacculus is made up of non-elastic material, sets elastic component to cause waist to be forced folding in waist It is folded, bending or wrinkle, to allow the expansion for realizing elasticity during use.

In another embodiment, multiple circumferential fiber materials along the axial length positioning of sacculus can be embedded in, pass through increase Or reduce the spacing of these fibers, elasticity can be increased or decreased respectively.In addition, the diameter of fiber can increased or decrease One step changes the elasticity of sacculus.

In another embodiment, sacculus inwall side uses elastomeric material, and outer wall side uses non-elastic material, passes through in waist The mode such as etching or electron beam weakens non-elastic material, obtains the waist of relative resilient.

In another embodiment, balloon waist is provided with braided members, and braided members can be by polyethylene terephthalate The multifibres strand of ester, polyethylene or other polymers or thin metal frame is constituted.Braided members can use the propylene of UV-curable Acid, polyurethane or other adhesive bondings are to sacculus.

Braided members allow the enlarged-diameter of waist, while make the axial length of waist reduce, this balance in waist and Pressure process after annulus contact becomes more apparent upon.Braided members may insure that the diameter of waist excessively will not extend and cause Destruction to annulus.A part for braided members extends to distal portions and proximal part, can prevent extension diametrically, from And help to improve the observation of flex point.

In another embodiment, braided members can when sacculus not yet expands with regard to pre-setting combination on sacculus, near-end Braided members deformation can be caused after part and distal portions expansion, braided members obtain less on the position corresponding with waist Diameter and the deformation that waist is limited with this.

Referring to Fig. 9, in another embodiment of foley's tube of the present invention, be additionally provided with the inside of sacculus 2 one it is less in Portion sacculus 2a, the diameter of annulus is measured by the inner balloon 2a of expansion.

Sacculus 2 and inner balloon 248 are filled with fluid by fluid passage 2c and fluid passage 2d respectively, and wherein fluid leads to Road 2c is connected by intercommunicating pore 2b with inner balloon 248.Interior sacculus 2a expands first when using, and as positioning sacculus, will Sacculus 2 is positioned at aortic valvular ring position, once inner balloon 2a is in place, can use the expanse leaflet of sacculus 2.

The proximal part of sacculus 2 has bigger diameter, is pushed into beneficial to by aortic valve in aortic sinus.

Referring to 10~Figure 13, in other embodiments of foley's tube of the present invention, sacculus is included around balloon shaft wire loop around row Five sub- sacculus 30 of cloth, the sidewall contact position of adjacent sacculus is connected with each other, and the central area of five sub- sacculus forms blood flow Passage 33, typically about 0.48 square centimeter, it is sufficient to keep the abundant blood supply to brain, if similarly using three sacculus, blood flow leads to Road area is preferably from about 0.056 square centimeter, and for four sacculus, it is preferably from about 0.237 square centimeter.

The near-end of each bulbec capsule is attached to center manifold 31 so that institute's sub-ball capsule can expand simultaneously.

In another embodiment, the periphery of five sub- sacculus is additionally provided with coating 34, and coating 34 is thin but can ensure strong The plastic material of degree, the inwall of coating 34 may be coupled to the laminating position of corresponding bulbec capsule, so can also form peripheral channel 35。

Coating 34 is connected on corresponding bulbec capsule, provide not only the stability of global shape, and is allowed by periphery Passage 35 causes the expansion of coating 34, but pressure should be slightly lower than inflated pressure so that sacculus is that the outer wrap is carried For uniform support.The pressure of peripheral channel 35 preferably in 1atm between 6atm, preferably in 2atm between 5atm.Bulbec capsule Internal pressure can be in the range of 2atm to 20atm.

In another embodiment, the periphery of five sub- sacculus is additionally provided with outer sacculus, and outer sacculus is dumb-bell shape, with what is expanded Distal portions and proximal part and the waist collected.The similar function with sacculus 2 in Fig. 1 of outer Saccular function, five sub- sacculus It is main to play internal supporting role.

In another embodiment, the interval position of five sub- sacculus is equipped with the pipe 32 for forming channel of blood flow, it is allowed to Blood flows through from pipe 32.Pipe 32 passes the position of five sub- sacculus and coordinated for sealing.

In another embodiment, five sub- sacculus 30 can also be interconnected.

Referring to Figure 14~Figure 16, in another embodiment of the present invention, in order to realize balloon distal portion 4, proximal part 3 and The expansion sequencing of waist 5, fiber reinforcement is used in proximal part 3, (for example wrapping up or be embedded to yarn), and distal portions 4 are simultaneously It is not provided with fiber reinforcement.Fiber reinforcement or elastic beam ring etc. can be set in waist 5.

When being filled with fluid, distal portions conformably expansion in left ventricular outflow tract serves the effect of grappling, and near-end Partially due to fiber reinforcement can prevent expansion, until the pressure in sacculus further increases, proximal part ability dilatancy.

Fiber is configured as the chi that expected expansion size and dimension, the i.e. proximal part of proximal part is consistent with aortic sinus Very little shape.

Fibre reinforced materials can include being fully oriented or partially oriented polymer yarn, and being fully oriented yarn has more preferably Constraint profile ability, and partially oriented yarn is more submissive in the initial bubble stage, thus when proximal part expands or There is slight deformation, but as further stretching can produce higher intensity and moulding ability.Using the yarn being fully oriented In the embodiment of line, knitted structure is preferably used.

In another embodiment, sacculus is overall uses fiber reinforcement, but because material is different, in distal portions and near-end Different elastic behaviors are presented in part, and the elasticity or compliance of proximal part are better than distal portions, and such as distal portions use PET Or nylon plastic material is constituted, and active proximal arteries and veins part is constituted using elastic filament (such as spandex), when sacculus is filled with fluid When pressure increases, distal portions first expand and are positioned at LVOT positions, and when pressure is further improved, distal portions shape is basic It is constant, and proximal part starts expansion, the optional about 200 danier polyurethane filament of elastic filament.

In another embodiment, sacculus can be the compound of film and fabric, and wherein fabric substantially covers whole sacculus, knits Thing can be made up of the PET yarns of 200-300 daniers for being knitted or weaving, film can by a kind of material (for example, silicones, Polyurethane or some other strong flexible polymers) constitute, the wall thickness of wherein distal portion office is about 0.015 to 0.02 inch, The wall thickness of proximal part is about 0.025 to 0.03 inch.Or in alternative solution, film can by such as silicones a kind of material Material is constituted, but construction silicones causes it to have about 10-15 hardness in distal portions, has about at active proximal arteries and veins 15-25 hardness, can control distal portions by different-thickness or hardness and first expands, and be expanded after proximal part.

Referring to Figure 17, foley's tube of the present invention also includes being used to make leaflet bending improve flexible beam ring, and beam ring is in sacculus Periphery and sacculus interaction clamp leaflet 7, beam ring for can deformation self-expanding material, including the ring with the phase separation of leaflet 7 Body 35 and the support arm 36 being connected in ring body 35, the proximal slide of support arm are arranged in catheter sheath, in retracted mode Under, the diameter of ring body is maintained at minimum dimension by support arm, when support arm distally promotes ring body, and the diameter of ring body expands Greatly.

Beam ring can independently of conduit advance and retract, sacculus be in shape it is elongated upon inflation, in leaflet expand, And leaflet is pressed against to the inner side of ring body.In operation, after proximal part is positioned at leaflet, beam ring stretches out from catheter sheath And deploy to be set in annulus periphery, further expansion presses against annulus in beam ring inner edge to the proximal part of sacculus, is clamping During annulus so that leaflet bending recovers flexible.

The structure of bending point allows broader leaflet to open, so as to allow blood better by valve, and the process can be with Carried out with the beam ring of different diameters repeatedly, multiple bending points are created in leaflet, when it is completed, make Deflation and by ball Capsule is retracted into sheath, then in beam ring retraction sheath, then is removed out of patient body.

Beam ring can set medicine-pouring hole along its inner periphery, for medicine such as anti-restenosis drugs to be filled into leaflet portion Position, injection can be communicated to the injection port at sheath proximal end.

In an alternative embodiment of the invention, the periphery of the sacculus is provided with limitting casing, can limit the maximum gauge of sacculus And skew is placed, limitting casing includes the spoke of more than three and two mounting rings of each spoke end of connection, installs ring set On conduit and positioned at the axial both sides of sacculus.

Referring to Figure 18, in an alternative embodiment of the invention, conduit is in the eccentric position of sacculus, in the axis part of sacculus Channel of blood flow 37 provided with insertion, can avoid sacculus from blocking the thrombosis that annulus position is caused, channel of blood flow 37 for a long time Place can also prevent from backflowing provided with check valve 38.

Blood stream pressure can be alleviated by channel of blood flow, the axial float of sacculus is prevented, check valve 38 can be located at channel of blood flow 37 center, distal end or any position therebetween.

Referring to Figure 19, in an alternative embodiment of the invention, sacculus 2 has two or more blood along conduit circumferentially Circulation road, rather than single central passage.Such as channel of blood flow 37a and channel of blood flow 37b in figure, the side wall of channel of blood flow With preferable intensity and non-resilient, mutual deformable squeeze after other zone broadenings of anti-channel of blood flow and sacculus.

Internal support can also be set on conduit, to keep the spatial shape of channel of blood flow, so as to prevent channel of blood flow Unnecessary expands outwardly.

In another embodiment, with reference to Figure 19, the periphery of sacculus 2 is additionally provided with the film 39 for envelope channel of blood flow, film 39 Cover channel of blood flow whole length direction, but proximally and distally open ended, channel of blood flow and film formation tubular structure, are blood Circulation road provides better structural support, but still allows blood flow to pass through.

Referring to Figure 20, in an alternative embodiment of the invention, sacculus 2 includes two parallel longitudinal sacculus, and two sacculus are total Volume expansion shape is similar to the embodiment described before, with the distal portions to grappling, the close end for expanding leaflet Point, two sacculus can expand successively in order can allow the blood flow of some direct motions to pass through.

In an alternative embodiment of the invention, other shapes can be presented in the distal portions of sacculus, and different shape can pass through fibre Dimension and film it is compound it is moulding realize, such as distal portions are for inverted umbrella or similar to anchor, and this shape is although radial direction Full-size keep constant, but cumulative volume reduced, and the volumetric usage of fluid is reduced when being inflated, therefore can be faster Fill on ground.

Referring to Figure 21~Figure 22, in an alternative embodiment of the invention, the spacing valve 40 of wire frame structure, limit are provided with conduit It is wire frame structure that position valve 40, which can have multiple, is uniformly distributed the periphery of proximal part upon inflation.Leaflet 7 is by close end When the extruding divided is expanded outwardly, it is resisted against on spacing valve 40, multiple block pieces 41 and mark can also be set on spacing valve 40 Remember thing 42, under the effect of block piece 41 many places bending occurs for leaflet 7, and its compliance, which is had, further to be improved.

Spacing valve is located at the bottom of aortic sinus, and against sustainer endwall, this will be stable before and during sacculus expansion And prevent dislocation.Once spacing valve grappling, inflated by leaflet to be pushed against spacing valve and neighbouring sustainer endwall.It is spacing Valve nickel can be titanium alloy material, and pre-setting handle.Block piece may be such that leaflet produces multiple bendings as stress collection knot Point, improves compliance.

Valvoplasty program described in invention, which is usually directed to apply in aortic valve, extends out power, this power And/or similar wound may cause valve ISR, so that valve leaflet is stiff and dumb again, for this reason, it may be necessary to will The therapeutic substance of medicine, interim placement brachytherapy source or other local deliveries is delivered to aortic valve, to prevent Regulation aortic valve ISR or progressive it is narrow.A kind of method for delivering this medicine is to elute to plant by topical remedy Enter thing.

For example, drug eluting implant can deliver taxol or any other taxane/Taxane derivative, thunder handkerchief is mould Element or rapamycin derivative, fluorouracil, other pharmacological agents, antimitotic agent, antiproliferative, protein, gene, Gene therapy vector, RNA/ nucleotides or any other prevents the medicament of valve ISR process.In addition, such device can be with Including decalcifying agent and limitation or the reagent of collagen deposition is reversed, and causes the favourable remodeling of valve leaflet by this way, It is narrow so as to reverse.Such device can also eliminate thrombus/inflammation/calcification.

In an alternative embodiment of the invention, anchor ring and multiple medicament elution finger pieces also can be set, anchoring ring is located at Neighbouring annulus in LVOT, medicament elution finger piece is angled and contact leaflet towards leaflet, the anti-restenosis needed for elution Medicine or material as listed above.Flexibility refers to implant can be by the conveying mechanism of foley's tube of the present invention, or can make Use single conveying mechanism.

As flexible another embodiment for referring to implant, it includes anchor ring and T-shaped medicament elution pod, and anchor ring is neighbouring Annulus, and T-shaped medicament elution pod is fixed to anchor ring and passes through valve, the elongated horizontal portion of T-shaped medicament elution pod towards near-end Tap touches the sustainer side of each leaflet base portion.Can in the way of time correlation by anti-restenosis drugs be transferred to leaflet position Put.T-shaped medicament elution pod can also replace with L-shaped.

In another preferred embodiment, the medicament elution post with single or dual barb is provided with anchor ring. Preferably by radio frequency, laser, high-energy low-frequency ultrasonic waves or other devices create puncture or multiple perforation in each leaflet, To allow medicament elution post to could be also simply pushed into leaflet.

Anchor ring and medicament elution finger piece can be made up of the bioabsorbable material absorbed with the time or allow cell The metal or polymeric web of infiltration and field planting are constituted.

In an alternative embodiment of the invention, the final expansion of sacculus and style characteristic are controlled using fibre reinforced materials, Referring to Figure 23, with reference to Figure 19, sacculus 2 has the channel of blood flow 37a and channel of blood flow 37b along conduit circumferentially, sacculus 2 Periphery is additionally provided with the film 39 for envelope channel of blood flow, the covering channel of blood flow whole length of film 39, in order to construct channel of blood flow 37a There is band 43 with channel of blood flow 37b sacculus peripheral shrouds, the surface that can constrain sacculus is not exclusively expanded.

Sacculus can be manufactured to the cross section of the non-circular shape in expansion, for example, star, triangle or square shape Shape, this may also lead to the formation of channel of blood flow.

Referring to Figure 24, in an alternative embodiment of the invention, the axis oblique of channel of blood flow 37 and sacculus, and in the outer of sacculus Surface opening, is used as the import and export of blood flow.This channel of blood flow being in tilted layout off axis easily allows each rank in balloon inflation Both antegrade during section.

Referring to Figure 25, in an alternative embodiment of the invention, distal end of catheter side is provided with netted anchor disk 44, and anchor disk 44 is swollen When swollen periphery and LVOT inwalls against.Anchor disk

Foley's tube of the present invention can be applied in various blood vessels and vascular system, for example, venous valve, other cardiac valves, Ankylurethria, coronary artery limitation etc..It will thus be appreciated that accompanying drawing and description herein is provided as example, so as to It is of the invention in understanding, and be not necessarily to be construed as limiting its scope.

Claims (10)

1. a kind of foley's tube, including conduit, the catheter proximal end side is used for connecting fluid conveying device, distal side be provided with it is described The sacculus of fluid delivery system connection, it is characterised in that the sacculus includes distal portions, proximal part and positioned at distal portion The waist divided between proximal part, the maximum gauge of the waist is less than the maximum gauge of distal portions and proximal part.

2. foley's tube as claimed in claim 1, it is characterised in that the flexible area of sacculus and inelastic region, in ball When capsule expands, inelastic region is expanded to maximum gauge prior to elastic region.

3. foley's tube as claimed in claim 2, it is characterised in that the waist is elastic region, distal portions and near End is divided into inelastic region.

4. foley's tube as claimed in claim 3, it is characterised in that the distal portions, proximal part and waist expander The bulbs of pressure to itself maximum gauge are different, or distal portions are identical with the bulbs of pressure of proximal part, and waist The bulbs of pressure are more than the bulbs of pressure of distal portions and proximal part.

5. foley's tube as claimed in claim 4, it is characterised in that label is set on sacculus and/or conduit.

6. foley's tube as claimed in claim 5, it is characterised in that the distal portions, proximal part and waist are each From independent bulbec capsule or at least adjacent both are structure as a whole.

7. foley's tube as claimed in claim 6, it is characterised in that the conduit is in the eccentric position of sacculus, in sacculus Axis part be provided with insertion channel of blood flow.

8. the preparation method of the foley's tube described in a kind of any one of claim 1~7, it is characterised in that including forming sacculus The elastomeric layer of shape, corresponding with distal portions and proximal part forms in the periphery of elastomeric layer and partly non-resilient Material layer.

9. the preparation method of the foley's tube described in a kind of any one of claim 1~7, it is characterised in that including forming sacculus The inelastic layer of shape, the periphery of inelastic layer and it is corresponding with waist be partly modified, obtain elasticity Waist.

10. a kind of medical treatment device, including any one of claim 1~7 foley's tube and for transporting fluid into ball The driving equipment of ductus bursae, it is characterised in that the driving equipment detects the pressure of fluid, and obtains sacculus according to pressure change The waist diameter of sacculus in conduit.