Echogenic sleeve

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to means with increased echogenicity for obtaining ultrasonic images. Device contains intervention device, image of which must be received by means of ultrasound, and echogenic polymer sleeve, located near intervention device and containing biocompatible deformable membrane, which covers at least part of intervention device. Topography of echogenic polymer sleeve is adjustable by means of its axial compression, which changes length of echogenic polymer sleeve relative to intervention device and forms riffles on biocompatible deformable membrane, riffles are visible for ultrasound and increase echogenicity of intervention device. Method of increasing echogenicity includes placement of biocompatible membrane near intervention device and compression of sleeve along axis to change its length and form riffles on biocompatible deformable membrane. In second version of device implementation mechanical deformation of echogenic polymer sleeve changes its thickness and forms riffles on biocompatible deformable membrane.

EFFECT: application of invention improves visibility of objects in ultrasound.

16 cl, 4 dwg

 

The technical field to which the invention relates

The present application relates to devices with increased echogenicity for better visualization while obtaining ultrasound images and to methods for increasing the echogenicity of the device.

The prior art inventions

Ultrasonic technology has advantages over other methods of obtaining images. Along with the advantage for health due to the reduction or exclusion of irradiation by x-rays (fluoroscopy) required equipment small enough to move it on a hand truck. It also has advantages in the diagnosis of the morphology of sub-surface tissue. In addition, the ultrasonic transducers can be manufactured small enough to be placed inside the body, where they can provide better resolution than the converters currently available for magnetic resonance imaging and x-ray computed tomography. Additionally, improvements to the tools that enhance their echogenicity in obtaining ultrasound images allow clinicians more quickly and properly to care for patients, saving time and money.

Numerous interventional instruments and tools are designed � polished surface, which make the tools, in fact, invisible in the ultrasound. Interventional tools and instruments are referred to here as "device (s)'. The present invention relates to an improvement that can increase the echogenicity of interventional devices.

The improvement of devices for ultrasound imaging or "echogenicity" have been studied for many years. When sound waves come into contact with a smooth surface, the angle of incidence and angle of reflection are equal. If the object is at an acute angle, most or all of the sound waves reflected from the power transmission/receiver. At such acute angles even devices with high reflectivity can be invisible to ultrasound, if the dispersion does not send the sound back to the source transducer. Conversely, if the object is perpendicular to that of sound waves reflected straight back, can cause the effect of "blinding" and impede the inspection of the object by the operator. This undesirable effect is referred to as specular reflection.

Manufacturers of medical devices have tried many ways to improve the visibility of objects in ultrasound. Examples include roughening the surface of the device, the capture of gas, the adhesion of particles to surfaces of the substrates, creation corner�representations or holes in the substrate and the use of dissimilar materials.

Disclosure of the invention

The object of the present invention is an interventional tool or tools with increased echogenicity, which contains the interventional tool or tools for which must be obtained ultrasonic image, and to echogenic polymeric sleeve with adjustable topography, located within close interventional tool or tools. In one embodiment, the implementation of the echogenic polymeric sleeve covers at least the area of interventional tool or tools. A polymeric sleeve may at least in one place attached to the interventional tool or tools. Provides a means of adjustment, so that the topography of this polymer sleeves when using interventional tool or tools could change.

Another variant of the present invention relates to a method for increasing the echogenicity interventional tool or tools. In this method echogenic polymeric sleeve with adjustable topography is located near the interventional tool or tools. In one embodiment, the implementation of the echogenic polymeric sleeve is positioned so as to cover at least the area of interventional tool or tools�Aria. This method provides a means of adjustment, so that the topography of this polymer sleeves when using interventional tool or tools could change.

In another embodiment, the implementation is provided a polymer sleeve that can slide over or around the interventional tool or tools in the future be attached to the interventional tool or tools at least in one place. Provides a means of adjustment, so that the topography of this polymer sleeves when using interventional tool or tools could change.

Brief description of the drawings

Fig.1 - interventional tool or tools with echogenic polymeric sleeve with adjustable topography, located next to the Toolbox.

Fig.2 - the same interventional tool or tools, in which the topography of a polymer sleeve was adjusted by shortening the length of the sleeve relative to the interventional tool or tools, increasing, thus, the echogenicity.

Fig.3 is a bar chart showing expressed in dB the result of the increased echogenicity compared with the control sample, instrumentation, corresponding to the present invention, with a shortened polymer �ukawa, as shown in Fig.2, and another commercially available device is coated.

Fig.4 is a graph of energy reflected at different angles, which shows enhanced echogenic response.

Detailed description of the invention

Interventional tool or tools with increased echogenicity according to the present invention comprises an interventional tool or tools for which must be obtained ultrasonic image, and an echogenic polymeric sleeve with adjustable topography, located near the interventional device.

Examples of interventional devices, for which there will be improved visibility in obtaining ultrasonic images in accordance with the present invention are, in particular, medical devices such as permanently implanted or temporarily installed devices, such as catheters, wire guides, stents and other accessories and tools, intervention tools and needles, such as septal puncture needle. However, as should be understood specialists in the art after reading the present disclosure, the methods described here improve the visibility of the interventional device in obtaining ultrasound images can be adapted for many other about�ASTA and devices.

In one embodiment of the present invention, the interventional device may be in itself undetectable by ultrasonic method. For example, the interventional device may have a polished surface, which upon receipt of ultrasound images can make the device virtually invisible.

In another embodiment of the interventional device may be echogenic. In this embodiment of the present invention, the echogenic characteristics of the interventional device can be similar or different from echogenic characteristics coterminous with polymer sleeves.

The echogenicity of this interventional device is increased in accordance with the present invention, positioning the echogenic polymeric sleeve with adjustable topography near the interventional device.

In one embodiment, the implementation of the echogenic polymeric sleeve covers at least the area of interventional devices. The degree to which the polymeric sleeve covers the interventional device, partly depends on how it is attached to the device, and on the orientation of the sleeve on the device relative to the ultrasonic source to produce images.

Echogenic characteristics of the device corresponding to the present invention, actively initsiiruetsya modified by the user, adjusting the topography of the polymeric sleeve. In one of the embodiments of the topography of a polymer sleeve is adjustable by changing the length of the polymeric sleeve relative to the interventional device. For example, in one variation of the implementation shown in Fig. 1 and 2, the length of the echogenic polymeric sleeve is shortened relative to the device, causing, thus, the sleeve will shrink. This shrinkage results in the folds, causing the increase in echogenicity. In other embodiments, the length of the wrinkled echogenic polymeric sleeve may increase relative to the interventional device, to lower the topography and, thus, reduced echogenicity. Change the topography of a polymer sleeve, corresponding to the present invention, can be reversible or irreversible.

In an alternative embodiment of the topography of the sleeve can be adjusted by introducing the fluid to cause a change in echogenicity. In another embodiment, the implement can be adjusted apparent density of the material of the sleeve, inserting the fluid manner, able to influence change in echogenicity; for example, if the porous material and the trapped air is replaced by fluid, echogenic characteristics may change. Adjustment echogenicity may takebut result of a change of thickness of the material. Mentioned the thickness variation can occur due to mechanical deformation, such as, for example, twisting of the material for the application of the voltage, reduce thickness, or extrusion of the material in the axial direction, causing the material shrinks, increasing thickness. Mentioned compression can be the result of rotation or wrap a deformable porous material around the axis of rotation. The term "deformable" as used here, means any material capable to be compressed and/or expanded under the action of external forces, such as foam RATT, silicone foam and foamed fluoropolymers and fluoroelastomers.

May be any biocompatible polymer mesh or film, suitable for echogenic response with minimal impact profile. Examples of polymers used in the sleeve corresponding to the present invention are, in particular, penopolietilen (ePTFE), a deformable polymer foam, porous fluoropolymers, PET, polyurethane, Pebax and its compounds. Among the commercially available polymers for use in the sleeve corresponding to the present invention, it is possible to call Gore DUALMESH.

In one embodiment of the invention, the film contains very thin biocompatible membrane or film, which can be given the shape of the tube or which may b�you stranded on the interventional device by the way for moving along the axis of the device. The choice of material should be such that the wrinkles in the material under axial compression (or allow axial compression) became visible in the ultrasound.

Increased echogenicity of the device corresponding to the embodiment of the present invention, was demonstrated experimentally. The results are presented in Fig. 3, which shows measured in dB increase in echogenicity embodiment corresponding to the present invention, compared with the control device and expressed in dB increase in echogenicity as compared to the control device Angiotech coated.

The following examples are not restrictive, are provided for further explanation of the present invention.

EXAMPLES

Example 1: Materials

The needle is stainless steel with a diameter of 0,040 inches and a length of 4.8 inches was used as the test object to the increase of echogenicity. Needle without modification was used as a control device for comparison with the results of the modification. The echogenicity of the needle is made of stainless steel, surrounded by a polymeric sleeve with adjustable topography in accordance with the present invention, also were compared with the echogenicity of the needle is coated Angiotech (Angiotech Pharmaceuticals, Inc., 1618 Station Street, Vancouver, BC Canada V6A 1B6).

Example 2: With�person

To evaluate and compare the approximate and the control devices were used three different ways.

All samples were exposed to the system for obtaining images using the acoustic wave. Apparatus for testing consisted of a receiving/transmitting transducer with a frequency of 7.5 MHz, mounted on a base with a sample holder located at a distance of approximately 2.5 cm focal length Converter. The transducer frequency of 7.5 MHz was created oscillations with a wavelength (λ) of 200 microns. At a distance of 2.5 cm beam width was approximately 1 mm. the Sample needle was mounted in the holder, located perpendicular to the axis of the radiating transducer. This corresponds to the angle of 0 degrees. The sample holder is removable for easy change of the sample. Holder with a magnet is held in a rotating goniometer to measure the angle of the location of the sample relative to the transmitting and receiving transducer.

The sample and the transducer were immersed in a tank of water at room temperature. Before data collection, each sample was aligned so that each of them was located at the same distance from the Converter and had the same orientation. This was done by increasing the attenuation setting on the controller pulse�on the exciter/receiver (approximately 40 dB), to prevent saturation of the received signal. The operator then visually controlled signal, while manually rotating the goniometer and switching fine adjustment knob on the transmitter to achieve maximum return signal. The attenuation is regulated to the reference point, approximately 1 V. Setting the attenuation and indication of the goniometer was recorded. The goniometer was rotated by 10 degrees with respect to the recorded testimony. Since the deviation from the perpendicular direction the signal is usually reduced (mirror reading), the attenuation is decreased. A decreased level allowed us to have a powerful enough signal during data collection, without bringing the receiver to saturation. The sample was rotated around the rotation angle to ensure that the signal is not in saturation, or significantly played at or near the inverter, outputting the signal from the window of data collection. Was controlled by the time shift. Significant temporal shift could indicate that the transducer is not aligned with the center or point of rotation of the sample. When the setup was finished, the goniometer was moved to around 10 degrees and the collection of data points was performed to 50 degrees in increments of 2 degrees. To the inverter connected equipment and testing device measured the reflection. For data collection and�further analysis we used the software Lab View hardware and software.

The second evaluation of samples was performed with a silicone shell that is immersed in the blood of ATS laboratories, to increase damping and to create a more real environment image. Samples using ultrasound system with a transducer at a frequency of 6.5 MHz, inserted into an empty shell. For each sample received still image. These images were compared visually with the reference images and was tested for compatibility with two-dimensional data Converter. Data were collected at three different time points. Between collecting data in the second and third time Converter reset. Thus, although the absolute scale of the graphs in dB is not the same, the focus is on the relative difference (Delta).

Measured in dB increased echogenicity compared with the reference sample device, the corresponding variant of implementation, and a device coated with Angiotech, shown in Fig.3.

1. Interventional device with increased echogenicity containing:
(a) the interventional device, the image which should be obtained by ultrasound; and
(b) echogenic polymeric sleeve, located next to the interventional device comprising a biocompatible deformable membrane, and a biocompatible deformable membrane covered�device at least a portion of the interventional device,
the topography echogenic polymeric sleeve is adjustable by axial compression echogenic polymeric sleeve,
moreover, the axial compression echogenic polymeric sleeve changes the length of the echogenic polymeric sleeve relative to the interventional device and forms wrinkles on biocompatible deformable membrane, these wrinkles are visible to ultrasound and enhance the echogenicity of interventional devices.

2. Interventional device with increased echogenicity according to claim 1, wherein the echogenic polymeric sleeve covers at least the area of the said unit.

3. Interventional device with increased echogenicity according to claim 1, in which the topography of a polymer sleeve is adjustable by changing the length of the polymeric sleeve relative to the interventional device.

4. Interventional device with increased echogenicity according to claim 3, in which the length of the echogenic polymeric sleeve is shortened.

5. Interventional device with increased echogenicity according to claim 3, in which the length of the echogenic polymeric sleeve is extended.

6. Interventional device with increased echogenicity according to claim 3, in which the adjustment by changing the length of the polymeric sleeve relative to the interventional device is reversible.

7. Interventional �disorder with increased echogenicity according to claim 3, in which the adjustment by changing the length of the polymeric sleeve relative to the interventional device is irreversible.

8. Interventional device with increased echogenicity according to claim 1, wherein the interventional device is a surgical instrument.

9. Interventional device with increased echogenicity according to claim 1, wherein the interventional device is a septal puncture needle.

10. Interventional device with increased echogenicity according to claim 1, wherein the interventional device is nechajannyi.

11. Interventional device with increased echogenicity according to claim 1, wherein the interventional device is echogenic.

12. Interventional device with increased echogenicity according to claim 11, in which the interventional device has echogenic characteristics different from characteristics of a polymer sleeve.

13. Interventional device with increased echogenicity according to claim 1, wherein the polymeric sleeve contains penopolietilen (ePTFE).

14. A method for increasing the echogenicity of interventional devices, including
placement of the biocompatible deformable membrane near the interventional device so that at least part of the biocompatible deformable membrane covers at least a portion of the interventional�on the device with the formation of echogenic polymeric sleeve, and
compression specified echogenic polymeric sleeve along the axis to change the length of the echogenic polymeric sleeve relative to the interventional device and formation of wrinkles on biocompatible deformable membrane, these wrinkles are visible to ultrasound and enhance the echogenicity of interventional devices.

15. A method according to claim 14, in which echogenic polymeric sleeve covers at least the area of interventional devices.

16. Interventional device with increased echogenicity containing:
(a) the interventional device, the image which should be obtained by ultrasound; and
(b) echogenic polymeric sleeve containing a biocompatible deformable membrane, and a biocompatible deformable membrane covers at least a portion of the interventional device,
the topography echogenic polymeric sleeve is adjustable by means of mechanical deformation echogenic polymeric sleeve, and
that mechanical deformation echogenic polymeric sleeve changes the thickness of the echogenic polymeric sleeve and forms wrinkles on biocompatible deformable membrane, which are visible to ultrasound and enhance the echogenicity of interventional devices.



 

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