CN110339456A - Sacculus dilating catheter and its sacculus - Google Patents
Sacculus dilating catheter and its sacculus Download PDFInfo
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- CN110339456A CN110339456A CN201910775996.6A CN201910775996A CN110339456A CN 110339456 A CN110339456 A CN 110339456A CN 201910775996 A CN201910775996 A CN 201910775996A CN 110339456 A CN110339456 A CN 110339456A
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- sacculus
- balloon
- tapering
- tip
- balloon body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1078—Urinary tract
- A61M2210/1082—Kidney
Abstract
The present invention relates to sacculus dilating catheter and its sacculus.A kind of sacculus for sacculus dilating catheter, along sacculus axially include balloon body, balloon body two sides sacculus tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering are radially made of multiple polymeric layers in sacculus, it is characterized in that, balloon tip includes metal.
Description
Technical field
The present invention relates to sacculus dilating catheter and its sacculus, effective expansion as such as Percutaneous nephrolith-otomy (PCNL) is filled
It sets.Especially, the present invention relates to the sacculus dilating catheters and its sacculus convenient for identification.
Background technique
Sacculus dilating catheter is now widely used in many fields, including blood vessel dilatation, placement bracket and creation kidney stone
Remove channel etc..
Two most important performances of sacculus dilating catheter are high burst pressure and distal end localizability.
Distal end localizability:
For doctor, determine that balloon distal position and sacculus active component are very heavy in the case where unexpected wounded patient
It wants, preferably to treat.
Such as Percutaneous nephrolith-otomy, if being blind puncture in expansion program, this can bring puncture to lose
Lose or damage the high risk of kidney essence.Therefore, surgeon urgently demand can see by medical image method through leather jacket
(especially distal portion) is set, to reduce the risk in puncture process.In the U.S., a kind of measure of visual PCNL is: in X-ray
Under perform the operation, so as to see the device part with X-ray impermeability in the picture.It is well known that X-ray
It radiates harmful to the health of patient and doctor.In addition, radioscopic image is actually shown two-dimensional structure, rather than three-dimensional structure,
To bring difficulty to confirmation device paracentesis depth.
In the market in most of sacculus dilating catheter, distal end is checked by fluoroscopy non-ultrasonic.?
China, most of doctor are ready to perform the operation under B-ultrasound.However, it is difficult in the course of surgery by ultrasonic wave come
Medical device is positioned, this will lead to patient and injures unexpectedly evil.Some doctors inject ultrasonic contrast into balloon body during surgery
Agent is to be detected.But balloon distal still cannot be visual.
Therefore, be increasingly required ultrasonic Detection Method help under carry out PCNL, doctor and medical device factory
Quotient have noticed the safer medical image measure of a kind of couple of patient and the radiationless harm of doctor.With echogenicity
Device can be shown as area pellucida, be easy to see in gray scale ultrasound wave image.
Reecho device is revealed as bright shadow in the gray scale image that B ultrasound instrument grabs, allow an operator to from
The lightness difference between medical device and surrounding tissue is distinguished in image.The key factor for obtaining bright shadow is that probe can be from device table
Face receives more backscatterings.In order to design the surface with higher backscattering, tissue and surfaces of medical devices it
Between creation have acoustic impedance difference (Z) interface, so that high frequency ping can be reflected.For theoretically, interface it is higher
Acoustic impedance difference should be such that 180 ° of reflections are more, and the echogenicity detected is better.Such as equation Z=ρ × v institute
Show, Z is the product of density of material and sound wave propagation rate within this material.Due to the balloon dilatation catheter in kidney during PCNL
Surrounding tissue and environment are the cortex renis filled with physiological saline and renal plevis, therefore the surface of reecho balloon dilatation catheter should
Compared with cortex renis and renal plevis there is significant density variation and sound wave to pass through speed difference.
Effective mode is creation gas-solid interface or liquid-solid boundary, because there is density variation harmony speed difference between them
It is different.In a variety of materials, the Z value of air is extremely low, and the Z value of metal is all higher than any polymer and liquid.Therefore, there are several ways
It is different come the Z value difference that increases interface, such as the processing of integrated metal material, patterned surface or the captured gas on apparatus surface.
United States Patent (USP) US2014/0243845A1 discloses a kind of double-walled balloon conduit, including by 50%-85% metal
A reecho layer or sleeve made of material and mixed with polymers.United States Patent (USP) US2013/0053770A1 also discloses one
Kind has at least two layers of foley's tube, wherein one layer is made of the mixture of 80% tungsten and 20% polymer.
United States Patent (USP) US2012/0277586A1 discloses a kind of reecho service pipe, has the pipe shaft in balloon interior
The metal sleeve of upper setting, multiple inner sleeves or winding band or looping silk on pipe shaft.US20080058702A1 is disclosed
Winding band or the band with textured surface are tied with catheter tube.Metalwork can also with sandblasting, physical deformation or machine into
Row processing, to improve echogenicity with surface roughness.
US2008/0097213A1, US20150165160A1, US5967988, US5490521A disclose anti-for echo
Penetrate the various patterned surfaces of conduit and biopsy forceps.These patterns include spherical shape on drainage catheter or hemispherical-shaped aperture, are inserting
Metalwork is embedded in the recess with different angle of laser processing, in the catheter main body being perfused for coronary sinus in pipe surface
Bump or other shapes.
The some examples for carrying out reecho improvement using gas, bubble or fluid are as follows.WO2007/102909A2 is disclosed
A kind of reecho by adding polymer fluid hole in balloon body blocks sacculus.US6106473 and WO98/
19713 disclose with bulk gas/non-pneumatic interface porous polymer coating, this is by physical agitation and can to release
Deflation body or H2Built-up or only volatile solvent the volatilization of chemical reaction between the blending constituent of O is built-up.
US6506156B1 discloses reecho coating, has multiple holes or glass microsphere particle.
High burst pressure:
Some materials can be visually under ultrasonic wave.However, it is difficult under high pressure these materials well with
Balloon tip (also referred to as neck) combines.If directly manufacturing balloon tip with these materials, sacculus dilating catheter
Burst pressure will substantially reduce.
Currently, not yet sufficiently developing the ultrasonic equipment and ultrasonic wave for so accurately detecting target as X-ray
Technology, for complicated detection environment.Since kidney stone generally has high ultrasonic echo signal (such as percutaneous
Kidney mirror art), therefore be difficult to distinguish balloon tip and calculus under ultrasonic wave, even if balloon tip is returned with superb sound
It is also such that the material of acoustical signal, which is made,.
Other problems
During surgery, especially intervention procedures, are difficult to measure the size of affected areas, for example, Aneurysmal neck size or
Kidney stone size.Sometimes, it is critically important to understand these information by doctor.
In addition, the only a part of balloon body is inserted into patient's body for certain operations (such as Percutaneous nephrolith-otomy)
It is interior.Doctor's inconvenience detects by an unaided eye insertion depth, so that correct placement medical device and unexpected injury can not be may cause.
Summary of the invention
Present invention seek to address that at least one above-mentioned problem.
According to an aspect of the present invention, the design of special balloon tip facilitates to identify sacculus (including the design to shape)
Tip.
According to another aspect of the present invention, the design of special balloon body also contributes to identification balloon body.
According to another aspect of the invention, scale designation is added on sacculus will be helpful to doctor and detects by an unaided eye be inserted into depth
Degree, so that correct placement medical device is without causing unexpected injury.By the sacculus with scale designation close to affected areas
It places, helps to measure affected areas size.
According to an aspect of the present invention, a kind of sacculus for sacculus dilating catheter is provided, axially includes ball along sacculus
Capsule main body, balloon body two sides sacculus tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, sacculus
Main body and sacculus tapering are radially made of multiple polymeric layers in sacculus, which is characterized in that balloon tip includes metal.
According to an embodiment, balloon tip is made of metal completely.
According to an embodiment, multiple recesses are formed on metal balloon tip.
According to an embodiment, balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymer
Layer is constituted, and is coated with metal sleeve or covering on balloon tip.
According to an embodiment, metal sleeve or covering pass through roughness meter surface treatment.
According to an embodiment, it is surface-treated as sandblasting, physical deformation or machining.
According to an embodiment, balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymer
Layer is constituted, and balloon tip is equipped with multiple axially spaced and circumferentially extending ferrule band.
According to an embodiment, metal sacculus tip end surface carries out patterned process, to form rectangular array, triangle battle array
Column, hemispherical array, diamond shape array, cylindrical array or the multiple parallel slots extended in a circumferential direction.
According to an embodiment, patterned metal sacculus tip end surface is coated with heat-shrinkable polymeric object covering.
According to an embodiment, balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymer
Layer is constituted, and balloon tip is tied with metallic fiber.
According to an embodiment, metal reecho layer is provided under the outermost polymeric layer of sacculus.
According to an embodiment, metal reecho layer includes metal multiple axially spaced and along sacculus circumferentially extending
Band.
According to an embodiment, the multiple polymeric layer includes polymeric binder layer, is mixed in polymeric binder layer
Close metal powder.
According to an embodiment, the multiple polymeric layer includes polymeric binder layer, the shape in polymeric binder layer
At having bubble or hole.
According to an embodiment, balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymer
Layer is constituted, and integrated metal ring is equipped on balloon tip, has the reciprocal multiple circumferentially extendings of opening direction logical in ring body
Through groove, they are axially apart from one another.
According to an embodiment, balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymer
Layer is constituted, and integrated metal ring is equipped on balloon tip, has the penetrating slot of continuous helical in ring body.
According to an embodiment, balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymer
Layer is constituted, and integrated metal ring is equipped on balloon tip, has multiple axially aligned windows, adjacent every two row in ring body
Window offsets one from another in the circumferential.
According to an embodiment, the scale designation that can be reflected ultrasonic wave is printed on balloon body outer surface.
According to an embodiment, first scale designation and scale designation and other scale designations every certain interval
Shape is different.
According to an embodiment, the initial position of scale designation may begin at balloon distal tapering, or start from away from balloon tip
At a certain distance from.
On the other hand according to the application, it provides a kind of sacculus dilating catheter, including sacculus as described above and passes through ball
The conduit in intracapsular portion.
Detailed description of the invention
According to the description below with reference to attached drawing to exemplary embodiment, other features of the invention be will be apparent.
Fig. 1 shows the metal tip of reecho sacculus;
Fig. 2 shows the jagged reecho balloon tips of tool;
Fig. 3 shows the reecho balloon tip with metal sleeve or covering;
Fig. 4 shows surface treated reecho balloon tip;
Fig. 5 shows the reecho balloon tip with multiple ferrule bands;
Fig. 6 A, 6B, 6C show the reecho balloon tip with various patterned surfaces;
Fig. 7 A shows the cross-sectional view of the sacculus of the prior art, and Fig. 7 B shows according to the present invention with ferrule band
The cross-sectional view of reecho sacculus;
Fig. 8 shows the reecho balloon tip for being equipped with multiple reecho rings;
Fig. 9 A (side view), 9B (end-view), 9C (perspective view) show a reality of integrated combined type reecho ring
Apply example;
Figure 10 A (side view), 10B (end-view), 10C (perspective view) show the another of integrated combined type reecho ring
A embodiment;
Figure 11 A (side view), 11B (end-view), 11C (perspective view) show the another of integrated combined type reecho ring
A embodiment;
Figure 12 shows an example of balloon body scale designation;
Figure 13 shows another example of balloon body scale designation.
Specific embodiment
Hereinafter, embodiment according to the present invention will be described with reference to the drawings.Reecho sacculus dilating catheter is echo
One example of medical device, such as perform the operation for percutaneous nephrolithy.However, it should be noted that the example of echo medical device is not
It is limited to this.According to the difference of concrete application purposes, echo medical device can be other medical treatment known to those skilled in the art
Device, such as abdomen medical device, gynicologycal medical device, heart medical device etc..
Embodiment described below is intended only as specific example.However, the present invention is not limited to implement described in specification
Example.
Generally speaking, as shown in Figure 1, showing the sacculus for sacculus dilating catheter.Sacculus includes the sacculus master of tubular
Body 1, balloon body two sides sacculus tapering 2 and extend from tapering and be fixed to supravasal balloon tip (or sacculus neck
Portion) 3, converged between balloon body and sacculus tapering by 4 phase of sacculus shoulder.
Reecho sacculus with reecho tip
More particularly it relates to the reecho tip of sacculus.Sacculus with reecho tip can be from week
It encloses and is identified in the physiological saline injected in tissue and renal plevis.The present invention can enhance the sound between balloon tip and ambient enviroment
Resistance difference.
Embodiment 1: the reecho sacculus with metal tip
As shown in Figure 1, the balloon distal tip 3 being connected with sacculus tapering can be made of metal material.Metal is than organ group
Knitting has higher acoustic impedance values (Z value) with organ liquid, facilitates the interface that building has significant Z value difference different.Applicable gold
Belonging to includes but is not limited to titanium, platinum, stainless steel, they have excellent bio-compatibility, can be used for processing metal tube.Pass through welding
Or metal tip is connected to sacculus tapering by bonding.Metal surface enhances sound wave and reflects back into ultrasonic probe.
It is further to improve as shown in Fig. 2, the hemisphere that diameter is 20-50 μm is made of laser ablation on balloon tip
Shape recess (is not limited to hemispherical, be also possible to other shapes), this will enhance reecho, because enhancing dissipating backwards for sound wave
It penetrates.
Embodiment 2: the reecho balloon tip with metal sleeve or covering
As shown in figure 3, the sleeve or covering on balloon tip can improve the echogenicity of balloon tip, this be because
It is increased for the acoustic impedance difference at interface.The advantages of metal sleeve is to be easy to be bonded with glue.It can choose with a thickness of 0.01-
Titanium, platinum or the goldleaf of 0.05mm, because these metals with this thickness are sufficiently flexible to be coated on balloon tip.It can be with
Using all metals with good flexibility.Titanium, platinum or the golden pipe that wall thickness is 0.02-0.05mm are preferably as having this
The pipe of wall thickness is sufficiently rigid to form sleeve.
What the US2014/0243845A1 and US2013/0053770A1 mentioned in background technique was directed to be polymer and
Metal powder composite layer needs to add high level metal to reach the ultrasonic development of polymer/metal powdered compound
Powder leads to the ductility reduction of compound, and extrusion molding is highly difficult, to combine extrusion molding feasibility, the gold of addition
The content for belonging to powder is limited, to limit the ultrasonic development of the composite layer.The present embodiment uses on balloon tip surface
The metal foil or sleeve of entity, this will increase acoustic impedance difference with polymer phase ratio, and manufacturing process is more simplified.
For the US2012/0277586A1 mentioned in background technique, integrated metal is for reecho on inner pipe
Property be unable to say for certain because sound wave in the first reflected at interfaces reached or scattering and balloon wall and will fill in sacculus
Medium caused by decaying will weaken reflection on an internal surface.The present embodiment between tissue and balloon tip first
Hardware is provided at interface (that is, interface that ultrasonic wave arrives first at) position, is not had as caused by other media in this way
Decaying, so that the probability for reflecting sound wave is bigger.
Fig. 4 shows further improvement.With the sandblasting of 60-120 mesh or physical deformation or machining metal sleeve or
The roughness with a few micrometers to some tens of pm is processed on the surface of covering, can further improve echogenicity, because changing
It has been apt to the backscattering of sound.
Embodiment 3: the reecho balloon tip with multiple ferrule bands
As shown in figure 5, being bonded on coiling direction (i.e. circumferencial direction) on balloon tip and axially spaced more
A ferrule band can improve the echogenicity at tip, because the interface between metal and ambient enviroment has big acoustic impedance
Difference.Metal can be titanium, platinum, gold, stainless steel or other metals with excellent bio-compatibility.On balloon tip surface
Bonding band is easy to, and ferrule band need to be only bonded on balloon tip with glue, and either densely cementing is also
It is discontinuously cementing.Such balloon tip can improve identifiability, because the band of bonding can be in ultrasonography
In be revealed as light and shade interval.Band thickness range can be set as 0.01-0.05mm, width range 0.7-2mm, between band
Between be divided into 0.5-2mm.
Embodiment 4: the reecho balloon tip with patterned surface
There is certain pattern in metal sacculus tip end surface.
In addition, patterning balloon tip surface can also be coated with heat-shrinkable polymeric object covering, due on patterned surface
Air gap thus air can be trapped between balloon tip surface and polymer, formed air/polymer interface, the interface
With very loud resistance difference, to improve echogenicity.
Patterned surface can be realized by machining on final metal balloon tip, be included in balloon tip molding
Laser lithography, etching, punching press or ball milling are carried out later.As shown in Fig. 6 A, 6B, 6C, picture on surface can be any shape, such as
Rectangular array, triangular array, hemispherical array, diamond shape array, cylindrical array extend multiple flat in a circumferential direction
Row slot etc..
US2008/0097213A1, US20150165160A1, US5967988, the US5490521A mentioned in background technique
Although disclosing various patterned surfaces, unused hydrophobic coating or covering protect pattern, cannot prevent tissue fluid or blood
Liquid penetrates into and forms polymer/liquid surface in pattern, rather than air/polymer interface, and polymer/liquid surface is to ultrasound
The albedo of wave is much smaller than air/polymer interface to the albedo of ultrasonic wave.In particular, US5967988 discloses one
The complicated method of kind is protected pattern using additional inner cavity, but is also not and is protected using covering.
Embodiment 5: it is wrapped with the echo balloon tip of metallic fiber
According to this embodiment, echo balloon tip is tied with metallic fiber.Advantage is, on the one hand with polymer surfaces and surrounding
Interface between tissue is compared to provide has more acoustic impedance value difference different between metallic fiber surface and surrounding tissue
On the other hand interface is irregularly arranged by metallic fibrous layer and provides rough irregular surface.Fiber cross section is in
Round or rectangle, and diameter is 0.05-0.5mm (circle) or side length is 0.01-0.05mm and 0.05-0.25mm.Metal includes
But it is not limited to silver, platinum, gold, stainless steel or silver-stainless steel composite material.It can be used with good biological compatibility and can be extruded into
Type is any metal of fiber.The US20080058702A1 that background technique is mentioned disclose be tied with catheter tube winding band or
Band with textured surface, but be not disclosed on balloon tip.
Sacculus with reecho main body and tapering
The invention further relates to the reecho sacculus with reecho balloon body and sacculus tapering, are used for percutaneous nephrolithy
Art.
US7309324B2 and US9114236B2 discloses non-compliance fabric sacculus.As shown in Figure 7 A, show as one
Example, the sacculus of the prior art can be made up of multiple layers, including polymeric substrate layers 10, polymeric binder layer 11, polymer film
12, polymer fibres layers 13, polymer coating 14 and outermost polymer protective layer 15.But in the sacculus of the prior art, not
Reecho element is set.
Referring to following non-limiting embodiment, reecho element can be added in sacculus according to the present invention, it is super to improve
Sound wave echoes are reflexive.
Embodiment 1: the reecho sacculus with metal reecho layer
As shown in Figure 7 B, compared with prior art, metal reecho layer 16 is added to as polymer coating 14 and most
Additional layer between outer polymer protective layer 15.As long as alternatively, providing metal reecho under the outermost layer of sacculus
Layer.In addition, in this case, metal reecho layer includes multiple axially spaced and circumferentially extends along sacculus
Band.The metal of band can include but is not limited to silver, gold, platinum, titanium or stainless steel etc., to provide the sound wave reflection of enhancing.It can
Using any metal with good biological compatibility.It is that can use in the advantages of ferrule band in balloon body or tapering
Make scale designation, to indicate balloon position under ultrasonic diagnosis.Band on the region of sacculus tapering can indicate that sacculus is bored
Whether portion is properly placed renal plevis, this judges whether expansion is effectively critically important for surgeon.The width of band in balloon body
Preferably 0.8-3mm, the width of band is preferably 0.8-2mm on the region of sacculus tapering.
Embodiment 2: metal component is mixed into adhesive between the different layers
According to the present embodiment, can also in polymer adhesive mixed metal powder, be capable of increasing so entire compound
The density of object.According to the present invention, for the polymer that polymer fibres layers 13 and outermost polymer protective layer 15 are bonding
Coating 14 (also as an adhesive phase) or for the polymerization that polymeric substrate layers 10 and polymer film 12 are bonding
Mixed metal powder in object adhesive phase 11, especially silver, titanium, Nitinol, bronze end, partial size are 1-10 μm, content 50-
80%, the density of entire sacculus is increased, to enhance the echogenicity in balloon body or tapering.
What the US2014/0243845A1 and US2013/0053770A1 mentioned in background technique was directed to be polymer and
Metal powder composite layer needs to add high level metal to reach the ultrasonic development of polymer/metal powdered compound
Powder leads to the ductility reduction of compound, and extrusion molding is highly difficult, to combine extrusion molding feasibility, the gold of addition
The content for belonging to powder is limited, to limit the ultrasonic development of the composite layer.
Reecho material is mixed (such as with polymer material with before sacculus extrusion molding and blow molding
US2013/0053770A1 is such, discloses the tungsten that 50-80% is added in a polymer matrix) it compares, it is mixed into adhesive
The advantages of reecho material is to be easier.
Embodiment 3: bladdery reecho sacculus within the adhesive layer
According to the present embodiment, the expansion/volatilization effect also generated using poor solvent to solvent type adhesive is in sacculus
Hole is generated in polymeric matrix layer.Specifically, by poor solvent volatilization can make adhesive phase (such as polymer coating 14 or
Polymeric binder layer 11) expansion, solvent molecule penetrates into macromolecular chain, but insoluble macromolecular chain.Then, when solvent from
When adhesive phase volatilizees, sacculus polymeric matrix layer below will irregularly be shunk, with formed it is irregular (such as it is concave-convex not
It is flat) surface, to form reecho gas hole.Interface between polymer and gas orifice gap provides acoustic impedance,
Help to improve echogenicity.
In addition, outermost polymer protective layer 15 can be omitted.In this case, polymer coating 14 can be viscous in itself
Mixture.In this way, being conducive to avoid losing because of bond properties caused by forming hole.
It is some specific examples made according to above-described embodiment below:
1. the example of reecho balloon tip
1.1 in an example of reecho sacculus, and the balloon tip being connected with sacculus tapering is made of metal material,
Specifically it is made of titanium.Titanium balloon tip is adhered on sacculus tapering.It is loud between titanium balloon tip and organ-tissue
Resistance difference constructs the interface with big sound wave backscattering on tip, so that the lightness of titanium balloon tip increases.
The another way for improving metal sacculus spearhead echo reflectivity is to go out diameter with laser ablation on balloon tip
For 45 μm of hemispheric notch.The echogenicity of balloon tip is also enhanced in this way.
1.2 can be arranged clad on balloon tip.Using the stainless steel foil and titanium foil with a thickness of 0.05mm, viscous
Mixture helps lower covering balloon tip, enhances echogenicity.
Another way is to carry out blasting treatment to the titanium foil of thickness 0.05mm and the stainless steel foil of thickness 0.07mm, with shape
It is the rough surface of 60-120 mesh at roughness.This coarse covering also enhances the echogenicity of balloon tip.
1.3 width are 1.0mm and the platinum with a thickness of 0.038mm, gold or silver-colored band are adhered to entire balloon tip periphery
On.Due to enhancing sound wave backscattering, the lightness of entire balloon tip is improved.
1.4 use stainless steel-silver composite fibre looping balloon tip.Stainless steel-silver the composite fibre for being 0.076mm with diameter
It is thickly wrapped on balloon tip as far as possible.The composite fibre of looping helps to substantially improve the echogenicity of balloon tip.
1.5 manufacture patterning balloon tip by machining.For example, one ring recess of machining.As a result, being improved
Tip image identification, in slot region lightness enhancing.
2. reecho balloon body or the example in tapering
2.1 in balloon body bonded metal band specifically can be bonded golden band in the main body of sacculus or tapering and cover
Cover entire tapering.Golden band is with a thickness of 10 μm, width 1mm.Improve the echogenicity in main body or tapering.
2.2 in balloon body bonded metal band specifically can be bonded golden band in the main body of sacculus or tapering and cover
Cover entire tapering.Golden band is with a thickness of 30 μm, width 1mm.Improve the echogenicity in main body or tapering.
2.3 in balloon body bonded metal band specifically can be bonded golden band in the main body of sacculus or tapering and cover
Cover entire tapering.Golden band is with a thickness of 10 μm, width 2mm.Improve the echogenicity in main body or tapering.
2.4 in balloon body bonded metal band specifically can be bonded golden band in the main body of sacculus or tapering.Gold
Band with a thickness of 10 μm, width 1mm, and between each ferrule band between be divided into about 1mm.Improve time in main body or tapering
Sound reflecting.
2.5 in balloon body bonded metal band specifically can be bonded golden band in the main body of sacculus or tapering.Gold
Band with a thickness of 30 μm, width 1mm, and between each ferrule band between be divided into about 1mm.Improve time in main body or tapering
Sound reflecting.
2.6 in balloon body bonded metal foil specifically can be bonded stainless steel foil on the tapering of sacculus or main body.
Stainless steel foil is with a thickness of 0.02mm, width 1cm.Improve the echogenicity of tapering or main body.
2.7 in balloon body bonded metal foil specifically can be bonded titanium foil on the tapering of sacculus or main body.Titanium foil
With a thickness of 0.05mm, width 1cm.Improve the echogenicity of tapering or main body.
Metal powder is mixed into 2.8 adhesive between the layers.Specifically, the silver powder that partial size is 6 μm is mixed into bonding
In agent, content 50%.Improve the echogenicity in entire balloon body or tapering.
2.9 add a strata above the first polymer layer (that is, it needs to layer Nian Jie with the second polymer layer) of sacculus
Urethane adhesive.Then, in polyurethane binder top coating dichloromethane or chloroform poor solvent thin layer, wave it
Hair.Due to foring hole in the polymeric layer below adhesive phase, the echogenicity of sacculus is improved.
The various embodiments described above and example improve the echogenicity of balloon tip, sacculus tapering or balloon body.
According to the invention, it is further possible to improve the echogenicity of balloon tip by other variants below.
Multiple reecho rings are mounted on balloon tip with certain axially spaced-apart, it is easily fabricated in this way, and easily
In progress ultrasound examination.
The material of manufacture reecho ring may is that the metal material for having carried out being surface-treated or be not surface-treated;
The alloy material for being surface-treated or not being surface-treated is carried out;Be surface-treated or has not been surface-treated and is included
The polymer material of microbubble;Or their combination.
Similar to the embodiment of Fig. 5, as shown in figure 8, reecho ring is mounted on the balloon tip on the outside of sacculus tapering,
This facilitates the high burst pressure for ensuring sacculus, and the burst pressure of non-reduced sacculus.
Compared with single ring is mounted on balloon tip, since multiple reecho rings are installed with certain axially spaced-apart
On balloon tip and the surface reflection of reecho ring material is stronger than the surface reflection of balloon tip material, therefore can obtain
More reecho surfaces are obtained, so as to enhance the ultrasonic visible and detectability of balloon tip.In addition, in each ring
Between in gap balloon tip material help to capture some air in use, this also contributes to the ultrasound of enhancing balloon tip
It is visual.
On the other hand, due to clinical needs, balloon tip is usually designed to very short and small.Therefore, reecho ring is also answered
The very little, in conjunction with balloon tip, and not too big the outer diameter and length for increasing balloon tip.However, it is difficult to more
A ring is integrated on balloon tip with certain axially spaced-apart.It can solve this problem by integrated combined type reecho ring.
(1) as shown in Fig. 9 A (side view), 9B (end-view), 9C (perspective view), there is opening direction opposite each other in ring body
The penetrating slot of multiple circumferentially extendings, they are axially apart from one another;
(2) as shown in Figure 10 A (side view), 10B (end-view), 10C (perspective view), there is continuous helical penetrating in ring body
Slot;
(3) as shown in Figure 11 A (side view), 11B (end-view), 11C (perspective view), have in ring body multiple axially aligned
Window, adjacent every two rows window offsets one from another in the circumferential.
For example, the specific design requirement of above-mentioned integrated combined type reecho ring can be such that
Ring body entity between opening has 2 to 5;
Ring body entity width between opening is 0.3-4mm;
Opening width is 0.5-2mm;
Ring thickness is 0.01-2mm.
Scale designation
According to another aspect of the present invention, the present invention relates to the scale designations printed on balloon body outer surface.
The scale designation is under fluoroscopy or ultrasonic examination as it can be seen that and also naked eyes are visible.
The scale designation can be used for measuring sacculus insertion depth, position the active component of balloon body and measure during surgery
Affected areas.
Gap between each scale designation can be 1-20mm, for example, 10mm.
In order not to same application purpose, the initial position of scale designation may begin at balloon distal shoulder, to identify that sacculus has
Imitate the position at position.Alternatively, also may begin at away from a certain distance from balloon tip, such as 5mm, with the unexpected wounded patient the case where
Lower determining tube insertion depth.
For ease of identification, first scale designation and every certain interval (such as 50mm) scale designation with it is other
The shape of scale designation is different, such as one thicker than another.
The material of scale designation can be the metal material for having carried out being surface-treated or be not surface-treated;Table is carried out
Surface treatment or the alloy material not being surface-treated;Be surface-treated or has not been surface-treated and includes microbubble
Polymer material;Or their combination.
Scale designation example 1:
As shown in figure 12, scale designation, first distally located sacculus of scale designation are added on balloon body outer surface
At shoulder, the last one scale designation is located at nearside sacculus shoulder.Gap between each scale designation is 1cm.These scales
It marks visible under fluoroscopy or ultrasonic examination.
The sum of scale designation is 16.The first, the six, the 11st and the 16th scale designations are more than other scale designations
Slightly.
PCNL operation in, doctor can by under fluoroscopy or ultrasonic examination calculus size and these scale marks
Note compares and measures calculus size.
In the aneurysm embolism operation using foley's tube, doctor can pass through the handle under fluoroscopy or ultrasonic examination
Tumor neck size measures tumor neck size compared with these scale designations.
Scale designation example 2:
As shown in figure 13, scale designation is added on balloon body outer surface, first scale designation is away from balloon distal point
5mm is held, the last one scale designation is close to balloon body proximal end.Gap between each scale designation is 1cm.These scale designations
It is visually visible.
The sum of scale designation is 12.The first, the six, the 11st scale designations are thicker than other scale designations.
In PCNL operation, doctor need to be put into sacculus internal suitable position, to avoid patient injury.Addition is in sacculus master
Scale designation on external surface can be used as scale, to record sacculus insertion depth.Doctor can be with naked eyes sacculus and sacculus
Conduit is inserted into internal certain depth.
Although describing the present invention by reference to exemplary embodiment it should be appreciated that the present invention is not limited to disclosed
Exemplary embodiment, the various embodiments described above can combine in any way.The scope of the appended claims should assign most wide
The explanation of justice, to cover all modifications and equivalent structure and function.
Claims (47)
1. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that balloon tip is made of metal completely.
2. sacculus according to claim 1, which is characterized in that be formed with multiple recesses on metal balloon tip.
3. sacculus according to claim 1, which is characterized in that metal sacculus tip end surface carries out patterned process, so as to
It forms rectangular array, triangular array, hemispherical array, diamond shape array, cylindrical array or extends in a circumferential direction more
A parallel slot.
4. sacculus according to claim 3, which is characterized in that patterned metal sacculus tip end surface is coated with thermal contraction
Polymer.
5. sacculus according to claim 1, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
6. sacculus according to claim 5, which is characterized in that first scale designation and the scale every certain interval
It marks different from the shape of other scale designations.
7. sacculus according to claim 5, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
8. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple
Polymeric layer is constituted, and is coated with metal sleeve or covering on balloon tip.
9. sacculus according to claim 8, which is characterized in that metal sleeve or covering pass through roughness meter surface treatment.
10. sacculus according to claim 9, which is characterized in that be surface-treated as sandblasting, physical deformation or machining.
11. sacculus according to claim 8, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
12. sacculus according to claim 11, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
13. sacculus according to claim 11, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
14. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple
Polymeric layer is constituted, and balloon tip is equipped with multiple axially spaced and circumferentially extending ferrule band.
15. sacculus according to claim 14, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
16. sacculus according to claim 15, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
17. sacculus according to claim 15, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
18. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, and balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple polymeric layer structures
At, which is characterized in that balloon tip is tied with metallic fiber.
19. sacculus according to claim 18, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
20. sacculus according to claim 19, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
21. sacculus according to claim 19, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
22. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that metal reecho layer is provided under the outermost polymeric layer of sacculus.
23. sacculus according to claim 22, which is characterized in that metal reecho layer includes multiple axially spaced
And along the ferrule band of sacculus circumferentially extending.
24. sacculus according to claim 22, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
25. sacculus according to claim 24, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
26. sacculus according to claim 24, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
27. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that the multiple polymeric layer includes polymeric binder layer, in polymer adhesive
Mixed metal powder in layer.
28. sacculus according to claim 27, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
29. sacculus according to claim 27, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
30. sacculus according to claim 28, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
31. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that the multiple polymeric layer includes polymeric binder layer, in polymer adhesive
Bubble or hole are formed in layer.
32. sacculus according to claim 1, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
33. sacculus according to claim 32, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
34. sacculus according to claim 32, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
35. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple
Polymeric layer is constituted, and integrated metal ring is equipped on balloon tip, has the reciprocal multiple circumferential directions of opening direction in ring body
Extend penetrating slot, they are axially apart from one another.
36. sacculus according to claim 35, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
37. sacculus according to claim 36, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
38. sacculus according to claim 36, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
39. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple
Polymeric layer is constituted, and integrated metal ring is equipped on balloon tip, has the penetrating slot of continuous helical in ring body.
40. sacculus according to claim 39, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
41. sacculus according to claim 40, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
42. sacculus according to claim 40, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
43. a kind of sacculus for sacculus dilating catheter axially includes balloon body, the sacculus in balloon body two sides along sacculus
Tapering and extend from sacculus tapering and be fixed to supravasal balloon tip, balloon body and sacculus tapering sacculus radially by
Multiple polymeric layers are constituted, which is characterized in that balloon tip, balloon body and sacculus tapering are all in sacculus radially by multiple
Polymeric layer is constituted, and integrated metal ring is equipped on balloon tip, has multiple axially aligned windows in ring body, adjacent
Every two rows window offsets one from another in the circumferential.
44. sacculus according to claim 43, which is characterized in that being printed on balloon body outer surface can reflect ultrasonic wave
Scale designation.
45. sacculus according to claim 44, which is characterized in that first scale designation and the ruler every certain interval
Scale designation is different from the shape of other scale designations.
46. sacculus according to claim 44, which is characterized in that the initial position of scale designation may begin at balloon distal cone
Portion, or start from away from a certain distance from balloon tip.
47. a kind of sacculus dilating catheter, including such as described in any item sacculus of claim 1-46 and leading across balloon interior
Pipe.
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CN113577509A (en) * | 2021-06-16 | 2021-11-02 | 上海脉全医疗器械有限公司 | Medicine balloon |
CN116963799A (en) * | 2021-11-09 | 2023-10-27 | 株式会社钟化 | Balloon catheter |
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