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CN207627722U - A kind of foley's tube for expanding aorta petal - Google Patents

A kind of foley's tube for expanding aorta petal Download PDF

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Publication number
CN207627722U
CN207627722U CN201720489287.8U CN201720489287U CN207627722U CN 207627722 U CN207627722 U CN 207627722U CN 201720489287 U CN201720489287 U CN 201720489287U CN 207627722 U CN207627722 U CN 207627722U
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CN
China
Prior art keywords
foley
waist
tube
distal portions
aorta petal
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Application number
CN201720489287.8U
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Chinese (zh)
Inventor
林浩昇
曾敏
訾振军
雷荣军
张志飞
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Hangzhou Qiming Medical Devices Co., Ltd.
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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Priority to CN201720489287.8U priority Critical patent/CN207627722U/en
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Abstract

The utility model discloses a kind of foley's tubes for expanding aorta petal, including conduit, the catheter proximal end side is used for connecting fluid conveying device, distal side is equipped with the sacculus being connected to the fluid delivery system, the sacculus includes distal portions, proximal part and the waist between distal portions and proximal part, under swelling state, the maximum gauge of the waist is less than the maximum gauge of distal portions and proximal part.Aortic stenosis or birth defect and/or impaired leaflet of the utility model foley's tube for treating Calcified, its planform can preferably be fixed on left ventricular outflow tract, meet the physiological make-up at aorta petal position, convenient for control deformation to be bonded aortic valvular ring, annulus damage or tearing caused by excessively expanding are prevented.

Description

A kind of foley's tube for expanding aorta petal
Technical field
The utility model is related to interventional operation equipment field more particularly to a kind of foley's tubes.
Background technology
In the prior art, foley's tube can be used for the treatment of calcific aortic stenosis, in use, receives The foley's tube of contracting state is inserted into through vein or artery and positions position in need for the treatment of, is then filled with sacculus by gas or liquid Conduit so that balloon catheter expansion struts the valve orifice of lesion, makes the diaphragm of calcification expand and bend, by adjacent diaphragms Be adhered and be partially separated, foley's tube is withdrawn from from vivo again after completing expansion.
The existing foley's tube generally predetermined shape with fixed diameter makes it by pressing by being filled with fluid raising pressure Contracting state is expanded to predetermined shape, applies the extruding force of expansion to valve.
Using the foley's tube (referring mainly to its inflatable position) of non-elastic material, after reaching predetermined shape, even if fluid Pressure increases, and effective treatment at elevated pressures, but non-resilient material may be implemented in the diameter change of foley's tube also very little Its predetermined shape of the foley's tube of material is possible to change during manufacture or collapsible, prepares to withdraw after in addition expanding When, it is also difficult to restore due compactness, larger vessel catheter sheath therefore, when recalling is needed, to increase wound Risk uses
Using the material of higher elasticity, still there is limitation, the diameter of elastic material can constantly increase with pressure, Maximum gauge not inherent limitation injures patient when that foley's tube may be caused to rupture more than its elastic limit, or even tearing Leaflet and contiguous teaming arrangement.
By taking aorta petal position as an example, foley's tube using when distal end stretch into left ventricle, proximal end is in aorta, 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, It is likely to occur axile displacement, such as slides into and stabs left ventricle.
Utility model content
The utility model provides a kind of foley's tube, can be used for treating the aortic stenosis or congenital different of Calcified Normal and/or impaired leaflet, planform can preferably be fixed on left ventricular outflow tract, meet the life at aorta petal position Reason construction prevents annulus damage or tearing caused by excessively expanding convenient for control deformation to be bonded aortic valvular ring.
A kind of foley's tube for expanding aorta petal of the utility model, including conduit, the catheter proximal end side is for connecting Connect fluid delivery system, distal side is equipped with sacculus be connected to the fluid delivery system, and the sacculus includes distal portions, closely End part and the waist between distal portions and proximal part, under swelling state, the maximum gauge of the waist is less than The maximum gauge of distal portions and proximal part.
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, to be placed on actively For at arteries and veins valve, waist is in relatively narrow annulus position, and the distal portions and proximal part expanded are in both sides of annulus and can be with It realizes self-positioning.
Proximal part is contacted with the leaflet of aorta petal, and leaflet is obtained leaflet calcium outwardly against to aortic sinus after expansion Change is partly slit open or ruptures, and to provide extending radially outwardly for big degree than the standard cylindrical balloon of the prior art.Position Distal portions in left ventricular outflow tract (LVOT) help to prevent sacculus during inflation due to blood flow acts on and downstream Migration.
Lumbar region can measure the compliance feature of annulus, to help doctor more to pacify with the diameter of subsidiary annulus Full execution valve expansion.
Preferably, the distal portions and proximal part are the non-elastic material area for first reaching maximum gauge when expansion, Reach the elastic material area of maximum gauge after when the waist is expansion.
Elasticity described in the utility model, it is non-resilient both be in contrast, not to be strict with the absolute number of its performance Value.Such as with ball intraluminal pressure increase inelastic region deformation expansion first to the maximum gauge of its pre-setting, and elastic region exists It just can further be expanded when continuing growing pressure, i.e. inelastic region is expanded to the maximum gauge state of itself first, behind elastic region It is expanded to the maximum gauge state of itself.
The size of proximal part and distal portions is set to completely attach to leaflet and LVOT respectively, and sacculus initially wear by expansion Annulus is crossed, proximal part and distal portions tend to distribute to every side of annulus, as fluid is further injected into ball In capsule, balloon interior pressure increases, and the diameter of waist also further increases.It is big absolutely when inner balloon pressure reaches about 2atm The leaflet of most of patients pushes aortic sinus to outward by proximal part.And under the pressure of about 2atm, distal portions reside in valve In the LVOT of the upstream of ring.
Sacculus is further injected fluid into later, and pressure further increases so that waist further expands and and annulus Contact, the fluid volume being injected into sacculus can continuously be monitored by filling fluid means by measurement, and pass through the pressure in sacculus Force snesor monitors the internal pressure of sacculus, obtains the relation curve between volume change and Pressure rise rates.
Preferably, the distal portions, proximal part and waist are separate bulbec capsule or at least adjacent The two is structure as a whole, and the conduit is equipped with the intercommunicating pore that fluid is filled with for distal end portion, proximal part and waist.
Distal end and proximal end described in the utility model refer to stretching into left ventricle runner in aorta side, if from the apex of the heart one Side is stretched into, then distal end and proximal end are just the opposite, but reason is similar, be can refer to understanding or is considered as equivalent.
In order to during surgery, real-time display or the swelling state for measuring sacculus, preferably, being distributed with around the sacculus aobvious Shadow Marking ring.
The developing mark ring can develop under x-ray fluoroscopy or develop under the ul-trasonic irradiation of 2D or 3D.Development mark Remember that ring can be by being coated in the periphery of sacculus using developing material, or band-like wind again is made in advance and is adhered to the outer of sacculus Week.
Developing mark ring can also be formed by conductive material, and frequency is generated after energization in 2-20MHz oscillating currents for feeling Survey imaging.In a word developing mark ring with regard to its material itself, the prior art may be used.
Preferably, the conduit upper edge is axially arranged with developing mark band.The material of developing mark band is referred to develop The related description of Marking ring.
Preferably, the developing mark ring has one or more, it is distributed in following position one or more:
The diameter maximum position of distal portions, the diameter maximum position of proximal part and waist.
Developing mark ring and developing mark band are in continuously distributed or are spaced apart in multiple dotted.
As a further preference, the developing mark ring has three, be in respectively distal portions diameter maximum position, The diameter maximum position of proximal part and waist;
In continuously distributed, remaining developing mark ring at two divides the wherein developing mark ring of waist in multiple dotted intervals Cloth.
Between distal portions and the non-expansion state and swelling state of proximal part, change in size is larger, therefore selects more A dotted be spaced apart to avoid local laceration or can fall off, and can further increase safety.
Pass through the axial position of developing mark band and developing mark ring in image, it can be determined that the position of foley's tube It sets, process especially can be further ensured that by image identification when distal portions enter left ventricular outflow tract and expand positioning Foley's tube locating effect.
Relationship between the physical length of developing mark band and re-imaging length can react and be converted to out observation angle.When When being observed from the oblique angle relative to balloon shaft line, developing mark ring is shown as ellipse, and ellipse can be obtained by radiographic measurement Long axis and short axle relative size, be then determined for practical ovality, these parameters can reflect the swollen of sacculus Swollen degree.
The degrees of expansion of sacculus can react proximal part to the extruding of leaflet and waist to annulus to a certain extent Against situation.
Preferably, the maximum gauge of the waist is 16~26mm, the maximum of the distal portions and proximal part is straight Diameter is 20~30mm.
Preferably, the sacculus is circumferentially arranged by multiple bulbec capsules, it is independent sealed between bulbec capsule.Such as it adopts With 2~5 sub- sacculus, can be bonded to each other along the position that they are contacted between adjacent bulbec capsule.The distal end of each bulbec capsule Side is closed, and by manifold to introduce fluid respectively, the central area of multiple bulbec capsules forms channel of blood flow for proximal lateral.
Optionally, in the external capsule of the periphery package of institute's sub-ball capsule.For further bulbec capsule to be engaged with each other or is kept Together, and between external capsule and bulbec capsule spacer region is also will produce, is used for blood flow, outer capsule inner wall may be fixedly attached to Each in bulbec capsule, stability is provided for entire perfusion balloon catheter structure.
The foley's tube of the utility model can more meet the anatomical structure of LVOT, prevent sacculus from moving, additionally by aobvious Shadow marks the axial position in image, it can be determined that the degrees of expansion of sacculus is reacted in the position of foley's tube, also allows in real time Guided operation process.
Description of the drawings
Fig. 1 is the schematic diagram that the utility model foley's tube is placed on aorta petal position;
Fig. 2 is the schematic diagram after the balloon catheter proximal end demi-inflation in Fig. 1;
Fig. 3 is the utility model foley's tube developing mark distribution schematic diagram.
Specific implementation mode
Referring to each attached drawing, for the present embodiment by taking the physiological structure at aortic valve as an example, figure middle and upper part, that is, proximal lateral is swollen Big aortic sinus 1, inside there is leaflet 2, is annulus 4 at most narrow place, then flowed out toward upstream, that is, distal side of blood flow for left ventricle Road 3 (LVOT).Occur 2 calcification of leaflet or to be adhered when lesion.
The present embodiment foley's tube includes elongated conduit 5, and 5 outside of conduit is sacculus 6, sacculus 6 divide for aortic sinus 1 The corresponding proximal part 7 in position, and the distal portions 9 that are anchored in left ventricular outflow tract 3, in proximal part 7 and distal portion It is narrowed waist 8 between points 9, the waist 8 and the position of annulus 4 after positioning are substantially corresponding.
Proximal part 7, waist 8 and distal portions 9 are integrated connectivity structure in the present embodiment, set on conduit 5 there are one Or multiple intercommunicating pore 5a, for being filled with gas or liquid to balloon interior.
In use, distal portions 9 first stretch into left ventricular outflow tract 3 and start to expand, proximal part can also be opened together Begin to expand, after the expansion of distal portions 9 by anchor itself in left ventricular outflow tract 3, prevents sacculus 6 on the whole under blood flow effect It is subjected to displacement, and with the expansion of proximal part 3, squeezes leaflet 2 towards reclining bending to restore certain at 1 inner wall of aortic sinus Compliance, while part calcification can also be adhered and be torn.
Maximum gauge after proximal part 7 expands in the present embodiment is 22-24mm, and the maximum after distal portions 9 expand is straight Diameter is 24-28mm, and the two is generally being expanded into maximum gauge in the pressure of about 2~4atm, and waist 8 is swollen under the pressure of 6atm It is swollen to arrive maximum gauge, about 16~22mm.
In order to control the expansion order of sacculus different parts to a certain extent,
Waist 8 is using elastic material (SC), such as selected from nylon, Surlyn, and vinyl, PVC, polyethylene, polyurethane, The copolymer of Pebax, alkene or these materials.
Proximal part 7 and distal portions 9 are gathered using non-elastic material (NC), such as selected from PET (Dacron), Teflon Acid imide, Kevlar wrappages.
When processing, it can be initially formed the elastomeric layer of balloon features, in the periphery of elastomeric layer and and distal portions Inelastic layer is partly formed accordingly with proximal part.Or it is initially formed the inelastic layer of balloon features, non-resilient The periphery of material layer and it is corresponding with waist be partly modified, obtain elasticity waist.
Developing mark ring has three in the present embodiment, including:
It is in the developing mark ring 9a at distal end portion diameter maximum position;
It is in the developing mark ring 7a at proximal end portion diameter maximum position;
And it is in the developing mark ring 8a of waist.
In continuously distributed, remaining developing mark ring at two is spaced apart wherein developing mark ring 8a in multiple dotted. In addition it is axially arranged with developing mark band 5b in conduit upper edge.
Pass through the axial position of developing mark band and developing mark ring in image, it can be determined that the position of foley's tube It sets, process especially can be further ensured that by image identification when distal portions enter left ventricular outflow tract and expand positioning Foley's tube locating effect.
When forming developing mark band and developing mark ring, the suspension containing label composition granule can be coated in a core On stick, the label nitride layer for being formed in plug outer surface is cut into endless belt after drying, then the endless belt is bound to specific bit It sets.Can also be by the suspension coating containing label composition granule on a substrate, the label that will be formed on substrate after dry Nitride layer is cut into belt strip, then the belt strip is incorporated on designated position around the home.Combined method includes solvent bonding, adhesive Bonding, uses priming paint or various method of plasma processing.
After sacculus expansion completely, waist and annulus location contacts, if observation visual angle is vertical with sacculus axis, each development mark Note ring and developing mark band are illustrated as a line.
Observation visual angle is parallel with sacculus axis, then developing mark band is shown as a bit, and each developing mark ring is circle, at this time It can easily know annulus size, if observation visual angle and sacculus axis have an angle theta, θ=arccos (long axis/short in image Axis), wherein long axis and short axle are elliptical long axis and short axle in image.Once known angle, θ on the contrary, then can determine annulus Oval index (ratio of EI, i.e. long axis and short axle).
In short, by the image size of developing mark band and developing mark ring and actual observation angle is combined, it can be with It is scaled the size of sacculus, convenient for tracking surgical procedure.
Disclosed above is only the embodiments of the present invention, but the utility model is not limited to this, this field Technical staff can carry out the utility model spirit and scope of the various modification and variations without departing from the utility model.Obviously These modification and variations should all belong in the protection domain protection of the requires of the utility model.In addition, although being used in this specification Some specific terms, these terms are merely for convenience of description, is not constituted to the utility model any specifically limited.

Claims (9)

1. a kind of foley's tube for expanding aorta petal, including conduit, the catheter proximal end side is for connecting fluid conveying dress It sets, distal side is equipped with the sacculus that be connected to the fluid delivery system, which is characterized in that the sacculus includes distal portions, closely End part and the waist between distal portions and proximal part, under swelling state, the maximum gauge of the waist is less than The maximum gauge of distal portions and proximal part.
2. the foley's tube for expanding aorta petal as described in claim 1, which is characterized in that distal portions and close First reach the non-elastic material area of maximum gauge when end is divided into expansion, when the waist is expansion after reach the bullet of maximum gauge Property material sections.
3. the foley's tube for expanding aorta petal as claimed in claim 2, which is characterized in that the distal portions, close End part and waist are that separate bulbec capsule or at least adjacent the two are structure as a whole, and the conduit is equipped with and is used for Distal end portion, proximal part and waist are filled with the intercommunicating pore of fluid.
4. the foley's tube as described in claim 1 for expanding aorta petal, which is characterized in that be distributed with around the sacculus Developing mark ring.
5. the foley's tube as claimed in claim 4 for expanding aorta petal, which is characterized in that on the conduit in an axial direction Equipped with developing mark band.
6. the foley's tube as claimed in claim 5 for expanding aorta petal, which is characterized in that the developing mark ring has One or more, is distributed in following position one or more:
The diameter maximum position of distal portions, the diameter maximum position of proximal part and waist.
7. the foley's tube as claimed in claim 6 for expanding aorta petal, which is characterized in that developing mark ring and development Label band is in continuously distributed or is spaced apart in multiple dotted.
8. the foley's tube as claimed in claim 4 for expanding aorta petal, which is characterized in that the developing mark ring has Three, it is in the diameter maximum position of distal portions, the diameter maximum position of proximal part and waist respectively;
In continuously distributed, remaining developing mark ring at two is spaced apart the wherein developing mark ring of waist in multiple dotted.
9. the foley's tube as described in claim 1 for expanding aorta petal, which is characterized in that the maximum of the waist is straight Diameter is 16~26mm, and the maximum gauge of the distal portions and proximal part is 20~30mm.
CN201720489287.8U 2017-05-04 2017-05-04 A kind of foley's tube for expanding aorta petal Active CN207627722U (en)

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CN201720489287.8U CN207627722U (en) 2017-05-04 2017-05-04 A kind of foley's tube for expanding aorta petal

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110201292A (en) * 2019-06-24 2019-09-06 天津正天医疗器械有限公司 A kind of vertebral body augmentation device
CN111772876A (en) * 2020-06-29 2020-10-16 科凯(南通)生命科学有限公司 A dilatation balloon for vesicular tandem valve
CN113693782A (en) * 2020-05-22 2021-11-26 杭州德晋医疗科技有限公司 Valve dilator and valve dilation system
CN117653436A (en) * 2023-11-28 2024-03-08 无锡市第二人民医院 Accurately-positioned staged saccule-expanded vertebral artery stent system and method

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110201292A (en) * 2019-06-24 2019-09-06 天津正天医疗器械有限公司 A kind of vertebral body augmentation device
CN113693782A (en) * 2020-05-22 2021-11-26 杭州德晋医疗科技有限公司 Valve dilator and valve dilation system
CN111772876A (en) * 2020-06-29 2020-10-16 科凯(南通)生命科学有限公司 A dilatation balloon for vesicular tandem valve
CN111772876B (en) * 2020-06-29 2025-04-01 科凯(南通)生命科学有限公司 A balloon for expanding vesicle-type string valve
CN117653436A (en) * 2023-11-28 2024-03-08 无锡市第二人民医院 Accurately-positioned staged saccule-expanded vertebral artery stent system and method

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Address after: 310051 311, 3 building, 2 building, 88 Jiangling Road, Binjiang District, Hangzhou, Zhejiang.

Patentee after: Hangzhou Qiming Medical Devices Co., Ltd.

Address before: 310051 2 Building 3, No. 88 Jiangling Road, Binjiang District, Hangzhou City, Zhejiang Province

Patentee before: Hangzhou Qiming Medical Device Co., Ltd.