Device with higher echogenicity

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to means with higher echogenicity for obtaining ultrasonic images. Intervention device contains intervention device, for which obtained is ultrasonic image, which has external surface, containing one or more topographic irregularities of in other cases smooth surface of intervention device and polymer film, which is in tight contact with external surface and closed at least part of one or more topographic irregularities, with tension of polymer film and resonance characteristic of polymer film are adjustable. In method of increasing echogenicity one or more topographic irregularities of in other cases smooth external surface of intervention film is (are) formed, with polymer film being placed in tight contact with external surface, with tension of polymer film being adjustable. Echogenic response of intervention device is regulated by means of device visualisation of device and regulation of polymer film tension, with adjustment of tension changing resonance characteristics of polymer film, covering one or more topographic irregularities.

EFFECT: application of invention makes it possible to improve visibility of objects in ultrasound.

13 cl, 4 dwg

 

The technical field to which the invention relates

The invention relates to a device 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), the necessary equipment is quite compact, which is convenient to move, and has the advantage in the diagnosis of the morphology of sub-surface tissues. Additionally, 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 devices that increase their echogenicity for the use of ultrasound allows clinicians to quickly and properly to care for patients, saving time and money.

Numerous interventional tools and instruments are designed with polished surfaces, �matured make the tools in essence, invisible to ultrasound. Interventional tools and instruments are referred to here as “device (s)'. The present invention relates to improvements in devices that can improve the echogenicity of interventional devices. To interventional devices include, in particular, septal puncture needle, as well as implantable devices, such as, in particular, stents, filters, stent graphs and/or heart valves.

The improvement of devices for ultrasound imaging or “echogenicity” have been studied for many years. When sound waves come into contact with the 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 of improving� 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, creating indentations or holes in the substrate and the use of dissimilar materials.

Summary of the invention

One object of the present invention relates to an interventional tool or device with increased echogenicity. The interventional tool or device for which must be obtained ultrasonic image, has a surface with one or more holes and a polymer film are in close contact with the surface of the tool or device that covers at least the area of one or more holes.

Another object of the present invention relates to a method for increasing the echogenicity interventional tool or device. In this method, one or more holes are in the surface of the interventional tool or device. The polymer film is then placed in close contact with the surface, covering at least the area of one or more holes.

Brief description of the drawings

Fig.1 - interventional tool or device with a plurality of holes in its surface.

Fig.2A and 2B is the same interventional tool or device shown in Fig.1, with a polymer film on�adaweya in close contact with the surface of the device so openings are closed.

Fig.3 - bar chart showing expressed in dB results increase compared with the control sample for the device corresponding to the present invention, with a polymer film that covers the hole in the surface of the device, as shown in Fig.2A and 2B, and other commercially available device with a coating.

Fig.4 is a graph of the reflected energy at various angles, which reflects the improved echogenic response.

Detailed description of the invention

The present invention relates to an improvement that can improve the echogenicity of these interventional devices. Device with increased echogenicity corresponding to the present invention comprises a device, the image of which must be obtained by means of ultrasound, having a surface with one or more holes. Interventional device corresponding to the present invention, further comprises a polymer film, which is in close contact with the surface of the device covering at one or more of the holes.

Examples of interventional tool or device that may be improved visibility in obtaining ultrasonic images in accordance with the present invention are, in particular, to such medical�e device, as a permanently implanted or temporarily installed devices, such as catheters, wire guides, stands 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 device upon receipt of ultrasound images can be adapted for many other areas and devices.

In accordance with the present invention, one or more holes are in the surface of the interventional tool or device. Holes corresponding to the present invention, there may be slits in the surface, which in other cases is a smooth surface of the device, or through holes through the surface of the device, or grooves formed in the surface of the device, or any other topographic irregularities in that in other cases the smooth surface of the device.

In one of the embodiments, as shown in Fig. 1, in the surface of the interventional tool or device for making the plurality of holes.

In one of variants of implementation, in addition to the holes in the surface of the interventional device�VA surface is also rough. In one of the embodiments of the surface roughness of the device has an average value of surface roughness less than 1 micron.

In embodiments in which the polymeric film is engaged with the device, making the surface roughness can be useful to increase adhesion.

The echogenicity of the present device is increased in accordance with the present invention by placing echogenic polymer film in close contact with the surface of the device to close the at least plot holes or openings in the surface of the interventional tool or device. In one of the embodiments of the polymer film covers the entire hole or holes in the surface of the interventional tool or device. In one of the embodiments of the polymer film covers the entire surface of the interventional tool or device. The coated polymer film can also restore luminal ability to pass medical devices (needles, dermatome, etc.), which must be added through holes. In the case of the slits or grooves, polymer film, especially a film of ePTFE, can restore the smoothness of the surface, which may be useful in most endoluminal procedures.

In some variations�tah implementation of the present invention, the echogenic characteristics of the device can be adjusted. One embodiment of the adjustable device comprises a hollow with through holes in the surface, a closed thin polymer film. The pressure inside the device can increase or decrease to change the resonance characteristic of the polymer film covering the said openings to create change echogenic characteristics of the device when viewed using ultrasound. In another embodiment, the implementation may be regulated by the tension of the polymeric film covering the opening of the device. Increasing or decreasing the tension of this polymer film, you can adjust the echogenicity of the device. The shape of holes may vary in order to achieve changes in echogenicity.

May be any biocompatible polymer film, suitable for echogenic response with minimal impact profile. In one of the embodiments of the polymer film contains a microporous fluoropolymer, such as penopolietilen (PTFE). In another embodiment of the polymeric film may be a thin polyolefin film, which may or may not be porous. Different thickness of material may change the topography, when the sleeve “activated”. Different topography will alter the echogenicity of the object. The thickness of the mentioned polymer films have bituminise 0.010 in. In another embodiment, the implementation of the thickness of the polymer film is less than 0.006 inches. In another embodiment, the implementation of the thickness of the polymer film is less than 0.003 inch.

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

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 sample to compare the results of the modification. The echogenicity of the needle is made of stainless steel with many holes in it, covered with a polymer film in accordance with the present invention, also were compared with needle coated Angiotech (Angiotech Pharmaceuticals, Inc., 1618 Station Street, Vancouver, BC Canada V6A 1B6). The holes are staggered at an angle of 45° with the diameter 0,178 mm and a gap between them of 0.38 mm.

Example 2. Methods

DL� evaluate and compare the processed samples 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 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 with the transmitter. This was done by increasing the attenuation setting on the controller pulse 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 knob fine adjustment �and the Converter, to achieve maximum return signal. The attenuation is regulated to the reference point, approximately 1 V. Setting the attenuation and the testimony 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 was not saturated, or substantially played at or near the inverter, outputting the signal from the window of data collection. Significant temporal shift was an indicator that the transmitter 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 test device measured the reflection. For data collection and subsequent analysis was performed with 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 sathanae to create a more real environment image. Using ultrasound system with a transducer frequency of 6.5 MHz, the samples were 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).

The third assessment was the analysis of the surface using a Veeco optical comparator Model NT3300. All obtained data were further processed by computer software to better assess the samples. Macroscopic tilt and cylindrical curvature were removed. To filter the frequencies below the 20-1mm was chosen as the Gaussian filter (Fourier). Incomplete intermediate points were restored with a maximum resolution of 3 or 5 pixels. All samples were masked at the edges to remove the areas with large precipitation data and anomalies associated with filtering. Two-dimensional samples were processed first, followed by a three-dimensional samples.

To demonstrate the characteristics of a surface was used on�traveler roughness height, Rt or PV, which is the maximum height from the maximum peak-to-trough on the surface profile within the length of the evaluation.

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) interventional device for which must be obtained ultrasonic image, wherein the said device has an outer surface containing one or more topographical irregularities in other cases, the smooth outer surface of the interventional device; and
(b) a polymer film which is in close contact with the outer surface of the specified interventional device and covers at least the area specified by one or more topographic irregularities,
thus the tension of the polymeric film and the resonant characteristics of the polymer film are adjustable.

2. Interventional device with increased echogenicity according to claim 1, wherein the specified one or more topographic irregularities are completely closed polymer film.

3. Interventional device with increased echogenicity according to claim 1, wherein the surface of the said device contains a variety of hole�rd.

4. Interventional device with increased echogenicity according to claim 1, wherein the polymer film covers the surface of the said device.

5. Interventional device with increased echogenicity according to claim 1, wherein the tension of the polymeric film covering the surface of the said device is adjustable.

6. Interventional device with increased echogenicity according to claim 1, wherein the polymer film contains a microporous fluoropolymer.

7. Interventional device with increased echogenicity according to claim 1, wherein the polymer film contains penopolietilen (PTFE).

8. Interventional device with increased echogenicity according to claim 1, wherein the interventional device is an interventional 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 surface of the interventional device is made rough.

11. Interventional device with increased echogenicity according to claim 9, in which the surface has a roughness less than 1 micron.

12. A method for increasing the echogenicity of interventional device, comprising stages on which:
form one or more topographical irregularities in other�their cases smooth outer surface of the interventional device; and
place the plastic sheeting in close contact with the outer surface, so that covered at least the area specified by one or more topographic irregularities, and the tension of the polymeric film is adjustable, and
regulate the echogenic response of the interventional device, wherein said adjustment includes the stages at which
visualize the device via ultrasound, and
adjust the tension of the polymer film in response to the visualization, this adjustment of tension of the polymer film changes the resonance characteristic of the polymer film covering the specified one or more topographical irregularities.

13. A method according to claim 12, V. polymer film which is placed so as to completely close the specified one or more topographic irregularities of the interventional device.



 

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