Patent Application
20130072792
The present invention relates to an ultrasonically visible medical balloon assembly and to a method of imaging a balloon. The invention also encompasses balloon catheter assemblies which are echogenic and radiopaque.
The use of balloon catheters is well documented. Common uses include angioplasty procedures, vascular occlusion and for the deployment of implantable medical devices. Typically, such balloons are made of a thin but strong material, Pebax being one example, which is able to be wrapped into a very small diameter around the balloon catheter and yet which is strong when inflated. Cutting or scoring balloons typically have one or more cutting or scoring elements provided on or in the balloon wall which extend beyond the perimeter of the balloon wall in a radially outward direction.
As a result of the structure and materials used for such scoring balloons, they are not particularly suited for traditional angiographic imaging techniques, particularly ultrasonic imaging, thereby having to rely upon less advantageous methods such as fluoroscopy, X-ray or CRT imaging. Specifically, such balloons tend to be very difficult to see and in some instances can be virtually invisible to ultrasonic imaging. In order to avoid having to rely on any of these less advantageous imaging techniques, such balloons can be inflated with a contrast media which is opaque to ultrasonic waves. However, suitable contrast media does not resolve the imaging difficulties when the balloon is in its deflated condition. Moreover, contrast media tends to be relatively more viscous than other fluids which may be used to inflate such balloons, with the result that the time required for inflation and deflation of a balloon with contrast media is increased. The increased viscosity also limits the minimum diameter of the inflation and deflation channels which must be used to feed the contrast media to the balloon and therefore the minimum achievable diameter of the balloon catheter.
Changes to the balloon structure, for instance to incorporate into the balloon walls radiopaque or echogenic elements, can alter the characteristics and performance of the balloon and are therefore not always advantageous.
Balloon catheter assemblies suitable for imaging are disclosed, for example, in U.S. Pat. No. 5,967,988, US-2005/0074406, U.S. Pat. No. 6,106,473, US-2009/0318746 and U.S. Pat. No. 4,349,033.
The present invention seeks to provide an improved balloon catheter assembly and in particular having a balloon which is more readily visible by imaging, in particular ultrasonic or magnetic imaging. The present invention also seeks to provide an improved method of imaging a balloon.
According to an aspect of the present invention, there is provided a medical balloon catheter assembly for endoluminal location within a patient, the assembly including a balloon catheter having a proximal end and a distal end; an inflatable balloon attached to the catheter at or proximate its distal end; the catheter including at least one inflation port at its distal end for the passage of inflation fluid into and out of the balloon; and a source of inflation fluid for inflating the balloon, said inflation fluid including a plurality of radiopaque or echogenic particles therein.
Advantageously, the particles, which may be microcapsules or pellets, are in suspension in the inflation fluid.
The particles, microcapsules or pellets, are preferably substantially spherical and may have a diameter of between 1 to 100 micrometres, advantageously between 2 to 10 micrometres. In the preferred embodiment, the particles, microcapsules or pellets have a diameter smaller than the wavelength of ultrasound used.
The particles affect the passage of ultrasonic waves directed to the balloon, by radiopacity or echogenicity, thereby making the balloon visible under ultrasonic imaging. Providing the particles within the inflation fluid allows the balloon to be of a conventional form and also can avoid the need for contrast media of the type commonly used. In the preferred embodiment, the particles are suspended in saline solution. Saline solution does not have the viscosity of contrast media and therefore can be provided through smaller diameter channels and which can provide faster inflation and deflation of the balloon. Moreover, saline solution does not suffer from the poorer biocompatibility of at least some contrast media.
The particles, microcapsules or pellets may be at least one of: solid and hollow. There is a number of possible particles which would be suitable. Examples include collagen microspheres, iodipamide ethyl ester, which can be used in solid form. Hollow particles could be filled with a contrast media and in one embodiment are filled with a perfluorochemical, that is a perfluorocarbon.
Other embodiments include hollow microcapsules or pellets filled with air, gas, or a gel or fluid of density different to that of blood. Gas filled particles or capsules can be of a heavy gas such as perfluoropropane, dodecafluoropentane, octafluoropropane, perfluorobutane, perfluorocarbon, perfluorohexane, sulphur hexafluoride, nitrogen and so on. These gases can give the particles good longevity as well as good echogenicity. Moreover, heavy gases have relatively low water solubility and thus are less likely to suffer from leakage from the particles or capsules.
It is preferred that the particles, microcapsules or pellets are provided in a concentration of 5 to 100 microlitres of particles, microcapsules or pellets per millilitre of inflation fluid. This, it has been found, provides good visibility of the balloon without being of too great a concentration in the carrier fluid.
The particles, microcapsules or pellets can made of polymethylmethacrylate (PMMA), PLA, PLGA, poly (methyl urea), amphiphilic block copolymers or polysaccharides, for example.
Advantageously, the microcapsules or pellets are of a reflective material, an opaque material and/or of a shape to promote Rayleigh scattering.
According to another aspect of the present invention, there is provided a method of inflating a balloon of a medical balloon catheter assembly, which assembly includes a balloon catheter having a proximal and a distal end; an inflatable balloon attached to the catheter at or proximate its distal end; the catheter including at least one inflation port at its distal end for the passage of inflation fluid into and out of the balloon; the method including the step of:
inflating the balloon with an inflation fluid including a plurality of radiopaque or echogenic particles therein.
Advantageously, the particles, which may be microcapsules or pellets, are in suspension in the inflation fluid.
Preferably, the particles, microcapsules or pellets have a diameter smaller that the wavelength of ultrasound applied during the step of inflation of the balloon.
Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which:
Described below are various embodiments of balloon catheter assembly provided with one or more echogenic elements. By echogenic it is meant elements which are visible to imaging, in the preferred embodiment to ultrasound imaging. As will be apparent from the teachings herein, the preferred embodiments provide elements which contribute or cause Rayleigh scattering of ultrasonic wave energy, although the elements could otherwise be absorbent (radiopaque) or reflective of ultrasonic waves.
The teachings herein can be used with any balloon catheters, including dilatation balloons, occlusion balloons, scoring or cutting balloons and other balloon structures used for angioplasty procedures, as well as balloons used in the deployment of implantable medical devices.
Referring to
At the distal end 18, there is provided a medical balloon 20 which comprises proximal and distal ends 22, 24 fixed in fluid-tight manner to the catheter 14. The method of fixing these ends 22, 24 of the medical balloon 20 could be any of the conventional ones known in the art.
The catheter 16 includes therewithin one or more lumens, not shown in
The assembly 10 also includes an inflation fluid source 30 which is coupled by means of a suitable conduit to the catheter 16 and in particular to the inflation/deflation lumen within the catheter 16 used for inflating and deflating the balloon 20. The nature of the inflation fluid source 30 is described in further detail below.
The sheath 12 is able to move along the length of the catheter 14 from the retracted position as shown in
The balloon 20 can be made of any of a variety of balloon materials including, for example polyether block amide (Pebax), nylon, preferably nylon 12, polyethylene, polyurethane and any other suitable material. It may be made of a single layer of material or a plurality of layers of material and may be compliant or non-compliant.
Furthermore, the balloon 20 can be of a type used to perform any of the functions commonly associated with medical balloons, as described above. The balloon 20 can, therefore, have a conventional form of a general cylindrical body portion with generally conical end portions, but may have a variety of other shapes including hourglass and so on. The balloon 20 may also include scoring or cutting elements thereon.
Referring now to
The balloon 20 has a balloon wall 34 which is substantially cylindrical with general conical end portions 22, 24 ending in necks which are sealed to the catheter-in fluid tight manner. The balloon is shown in an inflated condition in
The catheter 14 includes, in this example, first and second lumens 36, 38, which are shown in schematic form in
In the preferred embodiments, the particles 46 are provided in a sufficient o concentration (typically sufficient number per unit volume of liquid 44) to provide an amount of reflection or absorption of ultrasonic waves directed to the balloon 20 to give a measurable effect and in particular to be visible under ultrasonic imaging. It has been found that particles in a concentration of around 5 to 100 microlitres of particles, microcapsules or pellets per millilitre of inflation fluid gives good visibility of the balloon 20 when subjected to ultrasonic imaging. It will be appreciated that larger particle can be less numerous in number, whereas smaller particles would typically be greater in number to provide good characteristics in terms of visibility. The person skilled in the art will be able to determine an optimum particle size for the particular medical balloon within which they are intended to be used.
The particles 46 are preferably substantially spherical or otherwise rounded (for example oval) to give improved echogenicity in in particular to promote Rayleigh scattering of ultrasonic waves. If the case of radiopaque particles 46, these may also be substantially spherical or otherwise rounded but may have other shapes.
It has been found that particles having a diameter of between 1 to 100 micrometres provides good visibility of the balloon. It is preferred that the particles have a diameter of between about 2 to about 10 micrometres, which gives good visibility and good flow characteristics through the lumen 36, allowing the latter to be of small diameter.
The particles, which most preferably are made of a biocompatible material, may be microcapsules or pellets and may be solid or hollow. In the case of hollow microcapsules or pellets, these may be filled with air, gas, a gel or a fluid. There is a number of possible particles which would be suitable. Examples include collagen microspheres, iodipamide ethyl ester, which can be used in solid form. Hollow particles could be filled with a contrast media and in one embodiment are filled with a perfluorochemical, that is a perfluorocarbon. Other embodiments include hollow microcapsules or pellets filled with air, gas, or a gel or fluid of density different to that of blood. Gas filled particles or capsules can be of a heavy gas such as perfluoropropane, dodecafluoropentane, octafluoropropane, perfluorobutane, perfluorocarbon, perfluorohexane, sulphur hexafluoride, nitrogen and so on. These gases can give the particles good longevity as well as good echogenicity. Moreover, heavy gases have relatively low water solubility and thus are less likely to suffer from leakage from the particles or capsules.
It has been found that particles made of polymethylmethacrylate (PMMA) perform well, that is have good echogenicity in use. Other examples include poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), PCL, poly(methyl urea), amphiphilic block copolymers or polysaccharides.
The particles 46 may equally be made of any other ultrasonically reflective or opaque material.
Although saline solution is the preferred fluid 44, other embodiments may use a fluid which includes a contrast medium. In such embodiments, the fluid 44 may include only a relative weak concentration of contrast medium, thereby to prevent or minimise the problems of relatively high viscosity and toxicity of at least some contrast media known in the art.
It will be appreciated that the port 40 in the catheter 14 as well as the lumen 36, will be of a dimension to be able easily to allow the passage of the particles 46 therethrough when in the fluid 44.
Referring again to
The source 30 can be filled with liquid 44 in which the particles 46 are already in suspension. The source 30 may equally be provided with a mechanism, such as a mixing or shaking device, to ensure that the particles 46 brought into and remain in suspension. In another embodiment, the source 30 may include a separate feed or hopper of particles 46 which are mixed into the liquid 44 at the time of pumping of the fluid into the catheter 14 and therefrom into the balloon 20. Of relevance is that the particles 46 are carried by the liquid 44 into the balloon 20.
It is not necessary for the particles 46 to remain suspended in the liquid 44 once injected into the balloon 20, and it is not excluded that in some embodiments the particles 46 may be of a material which causes them to attach themselves to the inner wall 34 of the balloon. 20 once they have been injected into the chamber 42.
Referring now to
In
An ultrasonic probe 110 is placed in abutment with the body part 104, just above the vessel 102, and coupled with a suitable coupling medium 112, such as a gel, as known in the art. Ultrasonic waves 114 emanating from the probe 110 pass through the body part 104 and the vessel 102. The balloon catheter 120 does not substantially alter the ultrasonic waves 114, which thus pass through the balloon catheter 120 with virtually no absorption or reflection of the waves 114. As a result, the balloon catheter 120 appears substantially invisible under imaging.
The convention in the art is to fill the balloon 120 with a contrast media. However, as explained above, contrast media is generally viscous when in the concentration required to provide adequate radiopacity and also has toxicity, leading to risks to the patient should the balloon 120 burst in use.
Referring now to
In contrast to the example of
These embodiments are able to use an inflation liquid 44 which does not suffer from the disadvantages of known contrast media and in particular can use an inflation liquid 44 which is of relatively low viscosity and low toxicity, such as saline solution.
The embodiments described herein can provide visibility to a medical balloon 20 which would otherwise be substantially invisible under ultrasonic imaging and yet in a manner which does not suffer from the disadvantages of conventional arrangements.
As described above, the balloon 20 could be filled with a liquid 44 which also includes some contrast media to enhance the visibility of the balloon 20. In this embodiment, the contrast media can be of low viscosity and/or low concentration in light of the presence of the particles 46 within the inflation fluid.
It is to be appreciated that the balloon is most preferably impervious. It is not excluded, however, that the balloon wall 34 could be pervious, for instance to allow for the administration of a bioactive agent.
It is to be understood that only some embodiments are described above which would be apparent to the skilled person having regard to the teachings herein and that the described embodiments are not intended to be limiting of these teachings.
Although the claims are set out in single claim dependent form, it is to be understood that the claimed and disclosed features herein can be combined with one another.
| Number | Date | Country | Kind |
|---|---|---|---|
| GB 1116075.1 | Sep 2011 | GB | national |
