KR20000029894A - Male impotence diagnostic ultrasound system - Google Patents

Abstract

The apparatus for diagnosing male soundness by measuring the blood flow rate in the cavernous artery of the male penis according to the present invention comprises: at least one transducer for transceiving energy to measure the rate of blood flow in the cavernous artery and interpreting a corresponding Doppler effect; A transducer housing for supporting the transducer in a substantially fixed direction relative to the penis when the transducer measures the velocity of blood flow in the cavernous artery; And a mechanically coupled to the transducer housing to mechanically secure the actual transducer housing relative to the penis and to hold the at least one transducer in a direction of actual constant angle with respect to the cavernous artery during the sonographic diagnosis. Also disclosed is a method.

Description

Ultrasound system for diagnosing the sonar of a man {MALE IMPOTENCE DIAGNOSTIC ULTRASOUND SYSTEM}

Mutual References to Related Applications

The subject matter of this application is related to the subject matter of 60 / 023,959, filed August 9, 1996, and 60 / 041,361, filed March 21, 1997, both of which are incorporated by reference and 35 USC§119. It is hereby incorporated by priority as set forth in subsection (e).

Male tonicity is defined as a chronic inability to be erection hard enough to have sexual intercourse or to maintain an erection. This problem affects about 10 million Americans, and the incidence is increasing in older men. It is a source of great anxiety for many people and the reason why thousands of people visit physicians and other medical professionals each year.

During normal erections, neurochemical stimulation increases arterial inflow of the penis into paired cavernous arteries. As a result, the blood flow into the cavernous body increases. The subtunical venus plexus is compressed against the tunica albuginea and the venous outflow is reduced, causing blood to collect in the cavernous body. This increase in blood inflow and reduction in blood outflow result in vascular hyperemia of the penis, making it hard enough to erect and intercourse. Abnormal decreases in blood flow into the cavernous arteries and / or excessive venous outflow, ie somatic vessel outflow, are the major physical causes of the lupus. This abnormal blood flow into / out of the cavernous artery is caused by many factors, such as vascular diseases of atherosclerotic, traumatic arterial occlusive disease, or defective venoocclusive mechanisms. May be induced.

By measuring the rate of blood flow in the cavernous body, duplex ultrasonography has been successfully used to diagnose insufficient inflow and outflow of arteries. Typically, the transducer emits ultrasonic energy and the receiver receives ultrasonic energy reflected from the blood. The electronic circuit then measures the frequency difference between the transmitted and received ultrasound energy to measure blood flow velocity.

References:

Bassiouny, et al., "Penile Duplex Sonography in the Diagnosis of Venogenic Impotence," Journal of Vascular Surgery, Vol. 13, No. 1, pp. 75-83, January, 1991;

Cochlin, D.L., et al., Urogenital Ultrasound, A Text Atlas, pp. 257-258;

Kisslo, J., et al., Ed., Basic Doppler Echocardiography, pp. 11-16 and 190;

Levine, L.A., et al., "Measurement of Venogenic Impotence Penile Duplex Ultrasonography," Journal of Urology, 1990, 143: 211A;

Lue, T.F., et al. M "Vasculogenic Impotence Evaluated by High-Resolution Ultrasonography and Pulsed Doppler Analysis," Radiology, 1985, 155: 777-81;

Lue, T.F., et al., "Functional Evaluation of Penile Arteries with Duplex Ultrasound in Vasodilator Induced Erection," Urol Clin North Am 1989, 16: 799-806;

Meuleman, et al., "Alssessment of Penile Blood Flow by Duplex Ultrasonogranphy in 44 Men with Normal Erectile Potency in Different Phases of Erection," Journal of Urology, Vol. 147, pp. 51-56, January, 1992; And

Quam, J. P., et al., "Duplex and Color Doppler Sonographic Evaluation of Venogenic Impotence," AJR, 1989; 159: 1141-7.

See also US Pat. No. 5,482,039, which is all incorporated by reference.

A common method of measuring blood flow rate using Doppler shift is a well known technique. See, for example, US Pat. No. 4,722,347 to Abrams and Hovland. See also US Pat. Nos. 4,334,543, 4,485,821, 5,205,292, and 5,284,146. In addition, U.S. Provisional Application No. 60 / 023,959, attached above, is incorporated in part:

Advanced Technology Laboratories Ultramark 9 Ultrasound System brochure, 1993.

Advanced Technology Laboratories C7-4 HDI Broadband Curved Array Scanhead brochure, 1983.

Advanced Technology Laboratories Ultramark 9 Digital Computed Sonography System brochure.

Medasonics Neuroguard Transcranial Doppler Noninvasive Blood Flow Monitoring System brochure.

Medasonics F3PA Doppler Fetal Pulse Detector Ultrasound Stethoscope brochure.

One of the various requirements for accurate velocity measurement is the angle between the direction of transmitted and received ultrasound and the direction of blood flow. For accurate velocity measurements, this angle (hereinafter referred to as the angle of incidence or Doppler angle) must be accurately distinguished and / or maintained to some degree of precision.

With conventional ultrasonic devices, it is difficult to select and maintain this angle of incidence accurately. Many ultrasound devices suitable for measuring blood flow in the penis are held in hand. A serious limitation of hand held and used devices is that the angle of incidence changes over time as it is unacceptable for each reading, or even unacceptably for one reading.

This change is due to the inherent inaccuracies and inaccuracies in hand-held devices. The urologist does not know what the angle of incidence is, and even if he knows the desired angle, it is very difficult to obtain a desirable angle that can be reproduced by repeating measurements in a diagnostic process requiring multiple measurements. Even though it is not necessary to know the exact angle by using the relevant calculations, ie using the velocity ratio to effectively cancel the angle change, the angle must remain constant. This instability is a serious drawback of conventional ultrasonography devices, which is greater when measuring organs that can easily move, such as the penis.

Another drawback of the prior art ultrasonography devices and, in particular, the ultrasonography devices used to measure blood flow in the penis, is due to the inaccuracy of the current medical system with respect to the precise timing of measuring blood velocity during the diagnostic process. Typically, urologists or other medical professionals measure the flow rate of early cavernous arteries. Then, papaverine or other suitable vasodilator is injected or transfused to induce an erectile response. In addition, an angiography test is performed in which vasodilators are injected followed by continuous velocity measurement over time following patient self-stimulation. Some urologists believe that patients with an increase in blood rate of less than 25% are not sexually capable and are healthy if they are above 75%. If the growth rate is between 25% and 75%, the urologist will perform further tests.

More particularly, urologists measure the highest systolic and final diastolic rates before, during, and after 5, 10, and 30 minutes of vasodilator injection. According to some medical experts, the normal peak systolic speed is about 25 cm / sec. The resistance index is calculated as the difference between the highest systolic and final diastolic speed divided by the highest systolic speed. In other words,

Resistance Index (R.I.) = (best systolic speed-last diastolic speed) / best systolic speed.

A resistance index near or equal to 1 is considered to indicate normal results.

It is a matter of careful consideration to select the correct time of measurement after injecting vasodilator to make an accurate diagnosis. For example, urgent ultrasonography measurements lead to a false positive diagnosis because adult men are slower but often have a normal erectile response. Therefore, a need arises to eliminate the uncertainty due to inspection time.

The present invention is a device and method for diagnosing vasculogenic erectile dysfunction using Doppler frequency shift to more specifically measure the blood flow velocity of the penis for the diagnosis of erectile disfuction. It is about.

Embodiments of the present invention will be described with reference to the drawings, wherein reference numerals denote elements.

1 is an exploded perspective view of a sonic diagnostic device according to an embodiment of the present invention.

2 is a side view of the apparatus shown in FIG. 1.

Figure 3 is a top perspective view of the sonic diagnostic device according to another embodiment of the present invention.

4 is a side view of the apparatus shown in FIG. 3.

5 is a bottom perspective view of the apparatus shown in FIG. 3.

Figure 6 is a side view of a sonic diagnostic device according to another embodiment of the present invention.

7 is a perspective view of the device shown in FIG. 6.

Figure 8 is a plan view of the transducer housing of the sonic diagnostic device according to another embodiment of the present invention.

9 is a rear view of the apparatus shown in FIG. 8.

10 is a plan view of a pair of transducers according to an embodiment of the present invention.

11 is a plan view of a transducer housing according to an embodiment of the present invention.

12 is a side view of the pair of transducers shown in FIG. 10.

FIG. 13 is a side view of the transducer housing shown in FIG. 11.

14 is a perspective view of another transducer housing embodiment of the present invention.

15 is a perspective view of another transducer embodiment of the present invention.

16 is a cross-sectional view of the sound level diagnosis apparatus in the use position according to an embodiment of the present invention.

17-18 illustrate an intersection section of an ultrasound imaging beam in accordance with one embodiment of the present invention.

Explanation of symbols on the main parts of the drawings

10, 10 ′, 100, 260: test apparatus 20, 170, 210: transducer housing

30, 32, 205: converter 35: coaxial cable

40: thin film 45: border

50: lower housing 55: side wall

60 balun 67 relief valve

70 link portion 73 recess

77 taper 90 strap

93, 213: slot 97: end

110: spring device 120: standing end

130: compression spring 140: connecting piece

180: groove 190: tongue member

200: single converter 215: rail

220: sub-housing 225: finger

230: rider 240: center band

245 arrow 250 cap

255: gel 257: injector

265: elastic strap 270: end

280: fixing device 290: transmission converter

300: penis 305:

320: receiver converter 330, 340: passage

350: intersection

In order to overcome the above and other drawbacks, a device for diagnosing the man's tone in accordance with the present invention is a transducer that transmits and receives ultrasound or other suitable energy to measure the Doppler shift to measure the blood velocity of the penis. It includes. The transducer housing supports the transducer in a constant direction relative to the actual penis and substantially fixes the angle of incidence, ie the angle between the transmitted and received ultrasound or other energy and blood velocity vector. An acoustic coupling film can be used between the transducer and the penis to enhance the transmission of ultrasound energy to and from the penis.

The securing device is mechanically coupled to the transducer housing and at least partially encloses the penis to maintain the transducer housing substantially stable and in place during sonic diagnostics. According to one embodiment, the securing device comprises a pressure balun supported by a disposable housing and supports the penis and enables frictional contact with the penis. According to another embodiment, an elastic strap is used for this purpose. Optionally, adhesive tape secures the transducer housing above the surface of the penis. According to the present invention, the fixation device secures the device to the penis for a long time, actually locks the angle of incidence, and enables continuous measurement and recording of data throughout the entire diagnosis.

According to one embodiment, the transducer or transducers are movably fixed on the transducer housing to enable lateral adjustment of the ultrasonic transmission direction. According to another embodiment the transducers are fixed in the housing. By using multiple transducers, the blood flow in the cavernous artery of the penis can be measured simultaneously or at least immediately continuously.

Therefore, according to the present invention, the features of the invention summarized in summary can be used as part of a larger diagnostic system, including, for example, a monitor or other display device to continuously display speed data or other relevant data. Furthermore, for example for later review and analysis, larger systems may be designed to continuously record relevant data on a computer disk or printer; Real time video is not needed. Consists of portable and desktop computers.

According to another aspect of the present invention, a method for diagnosing a male's penis comprises placing at least one transducer over a penis to transmit energy, such as ultrasound energy, in the cavernous artery. The transducer is preferably supported by a movable or fixed housing. The housing is secured to the penis using a pressure balloon, elastic string, tape, or the like. Once the device is secured, the blood velocity in the cavernous artery is measured continuously, preferably before, during or after injection of the vasodilator. According to one embodiment, the continuous measurement data is stored on disk and / or continuously displayed on a monitor screen, for example.

In accordance with the present invention, the transducer can be used to measure the diameter of the penis during diagnosis to further aid diagnosis. This graphical representation of the penis diameter then appears in relation to each other in relation to the aforementioned blood flow rates.

Embodiments of the present invention have significant advantages in that they are relatively inexpensive, easy to use, relatively operator-free, accurate over a wide range of speeds, and can be measured repeatedly to test the efficacy of treatment over time. to provide.

Detailed description of the preferred embodiment

As noted above, a major advantage according to embodiments of the present invention is that the elements used to transmit and receive energy to measure Doppler frequency variations, i.e. the transducers of the ultrasound according to the present invention, are substantially positioned in the proper position relative to the penis and the cavernous artery. It is fixed. These innovations in positioning establish and fix the angle of energy incidence in the blood flow passages in the cavernous arteries, accurately measure the velocity, and, in turn, allow urologists and other medical professionals to make more accurate diagnoses. In addition, the speed can be measured continuously for a long time, and the inaccuracy related to the timing for measuring the speed disappears.

Embodiments in accordance with the present invention can be used to measure blood flow in various other parts of the body. For example, intravascular flow in arms, legs, fingers, neck, or elsewhere can be measured. Therefore, although the preferred embodiment of the present invention will be described with respect to the process of diagnosing the penis and the genitalia, the present invention is not necessarily limited to such embodiment.

Returning to the drawings, FIGS. 1-2 illustrate a probe apparatus 10 for diagnosing sound levels in accordance with one embodiment of the present invention. Test apparatus 10 may be used as part of a large acoustic diagnostic system, as described below. The test apparatus 10 includes a transducer housing 20 to support at least one transducer, such as transducer 30 and transducer 32, at a substantially fixed angle of incidence. According to one embodiment, the transducers 30, 32 transmit ultrasonic energy, but other transmission / reception mechanisms known to be usable in an environment measuring Doppler shift may be used, for example other types of acoustic or radar instruments.

The transducers 30, 32 (or equivalently used in non-ultrasound systems) are placed on each angle relative to the penis to create a known angular direction, ie a known angle of incidence, for the flow of blood in the cavernous artery. The coaxial cable 35 or other device / system controls the transmission and reception of ultrasonic signals and provides transducers 30 and 32 to electronics (not shown) that calculate and represent Doppler frequency variations, blood velocity measurements and / or other data. Connect.

According to a preferred embodiment, each transducer 30, 32 is a split-D transceiver of constant wavelength. It is effective for each transducer to be separated into two separate sides, one side continuously transmitting and the other side continuously. The split-D configuration is very advantageous because it does not need to align several transmitter-receivers in an angular manner and does not need to make other adjustments resulting from the use of separate transmitters and receivers in pairs.

The transducers 30 and 32 can also be used in what is known as the A mode, which uses ultrasound or other energy to measure various related distances. Therefore, the change in the diameter of the cavernous artery can be measured and indicated, as in measuring and indicating the diameter of the penis itself to indicate the change in the erection of the penis. You can also visually identify the location of blood vessels. Measuring and presenting these values combined with blood flow rate values over time provides additional diagnostic tools for urologists. A mode measurements can also be used to accurately align ultrasound or other beams with respect to the cavernous artery.

Of course, other forms and configurations of the transducer are possible. For example, single-converter embodiments such as pulse-wave piezoelectric devices can be considered. Here, the transmission mode is followed by a rest mode, which is then switched to the reception mode to receive the reflected energy. As a result, the pulses are mixed, so comparators and specialists must place the focus depth accurately, which necessitates a somewhat disadvantageous effect for the reasons mentioned above. Even when transducer alignment is used, the angle of incidence is mechanically formed and substantially fixed relative to the direction of blood flow in the cavernous artery.

Continuous ultrasound or other forms of systems may also be considered. This uses separate transceiving transducers, one on top of the penis and one on bottom of the penis. Specific examples according to this embodiment will be described later with reference to FIG. 10.

Two transducers 30, 32 are for each one cavernous artery as shown in FIG. 1. The use of two transducers enables the measurement, display and comparison of blood flow rates in two arteries, before and after vasodilator injection, continuously or simultaneously. In addition to accelerated acceleration, continuous peak systolic velocity and end diastolic velocity can be measured / calculated and displayed for two arteries. Of course, optionally a single transducer or two or more transducers can be used to measure the flow in the various vessels at various locations. For example, the device according to the invention can also be used for making measurements regarding urinary tract.

The transducers 30 and 32 are preferably configured in a finished form that is readily available from companies such as Blatec, Inc. of Pennsylvania State. Such ultrasound transducers typically have a concave lens on the front side and adapt the sound waves to the desired depth, in this case the cavernous artery.

An auxiliary lens can be used to bend the ultrasound wave to the desired angle of incidence. According to one embodiment, an auxiliary lens is placed in the air gap between the transducer and the patient's body, reducing the amount of gel or other acoustic filler material required therein. According to Snell's law, the speed of sound difference between the lens and the patient's tissue affects the degree to which the ultrasound curves as it passes through the tissue. Therefore, the secondary lens lowers the angle between the transducer housing and the tissue to less than 60 degrees, providing a more concentrated and comprehensive device.

As mentioned above, it is preferred to use acoustic fillers in embodiments of the present invention. Since air does not conduct ultrasound energy well, fillers are generally needed to direct ultrasound into the patient's tissue with minimal attenuation.

Among such materials that can be suitably used according to the invention are non-invasive hydrogel skin pads from LecTec Corporation, Mintoka, Minnesota. As shown in FIGS. 1-2, the skin pad 38 includes a thin film material 40 surrounded by the edge 45. According to a preferred embodiment, the top and bottom and edges 45 of the membrane 40 are adhesively adhered to the surface of the penis to be stable. The pad 38 is preferably disposable and can be used alone to assure the patient that the portions of the test apparatus that are kept clean and in direct contact with the penis are clean and sterile.

Instead of or in addition to the pad 38, Omnigel from Echo Ultrasound, Reedsville, Pennsylvania Preference is given to using ultrasonically transmitted gels having a viscosity of at least moderate, such as).

Once a urologist or other medical professional places the pad 38 (or other filler) directly on top of the penis, the transducer housing is placed directly in contact with the membrane 40 for optimal acoustic coupling. 20 is located at the top. Medical professionals then place the fixation around the underside of the penis to secure the transducer housing in place on the penis. According to the embodiment of FIGS. 1-2, the fixing device consists of a disposable lower housing 50 and is fixed to the transducer housing 20 in the manner described.

The disposable lower housing 50 includes two upstanding sidewalls 55, between which are supported by a disposable pressure balloon 60. The pressure balloon 60 supports the patient's penis and fits in its shape, expanding along the bottom of the housing 50 and, if necessary, even above the side wall 55. As the size of the penis increases during the erection reactor, the pressure balloon 60 keeps the penis in constant contact with the transducers 30, 32 through the membrane 40. The balloon 60 maintains the position of the penis as it grows, thereby preventing it from moving substantially from side to side. Therefore, a substantially fixed relationship between the penis and transducers 30 and 32 is maintained.

According to one embodiment, the balloon 60 has a slot at the opposite end of the balloon to support and adjust the side wall 55 of the housing 50. While assembling the device, the balloon 60 only slides over the side wall 55 because it is securely fixed on the lower housing 50. The balloon 60 rises above the side wall 55 to centrally position and comfort the penis within the housing 50 and is preferably substantially U-shaped with respect to the bottom of the housing. The balloon 60 does not block blood flow and maintains substantially constant pressure between the transducer and the penis.

According to one embodiment, the balloon 60 includes a fill valve 63 and a relief valve 67 of constant pressure to maintain a constant and desired pressure within the balloon. Optionally, it is not necessary to use valves 63 and 67 to reduce the complexity and cost associated with the number of parts connected to the balloon 60.

As shown in FIG. 2, the lower housing 50, the pad 38 and the transducer housing 20 are all connected by the link portion of the side wall 55. The link portion 70 includes a central recess 73 and a tapered portion opposite, thereby facilitating the interior of the corresponding slot of the transducer housing 20 (93 shown in FIG. 3). Keep it inserted. The link portion 70 is preferably connected in one piece with the side wall 55. Optionally, the sidewalls 55 of the transducer housing 20 and / or the lower housing can be adjusted perpendicularly to one another in order to adjust the size of the space between the lower housing 50 and the transducer housing 20. It may include. Such a structure may have the form of a toothed section extending towards the housing 20 on or near the side wall, for example. For example, the corresponding portions in the form of gears, ratchet wheels, and / or pawls are supported by the transducer housing 20 and engage the teeth with the side walls 55 to engage. . This structure secures the lower housing 50 in the desired position with respect to the transducer housing 20, but still allows for easy adjustment.

The housings 20 and 50 and the link portion 70 are preferably made of injection molded plastic, but other suitable materials may be used, such as, for example, nylon, various polymers or metals.

3-5 illustrate another test embodiment 10 ', wherein the fastening device for securing the transducer housing 20 in place includes a strap 90, such as a string of rope, paper and / or fabric type; It is made of straps and, optionally, Velcro, tape or other forms of fastening to achieve a comfortable tightening around the penis. The tip 97 of the strap 90 facilitates frictional engagement with the penis by passing through the slot 93 in the transducer housing 20. According to this embodiment, even if the strap 90 is potentially retracted and not as comfortable as the patient described above, this has the advantage of being simple to adjust and simple to operate. This is also disposable like the housing 50 of the embodiment described above. Pad 38 may also be used in combination with this embodiment, but is not shown to simplify the drawing.

Other devices or similar transducer supports for securing the transducer housing 20 may be contemplated. For example, a double adhesive tape may be used on the upper surface of the penis to hold the transducer in place and need not extend to the lower surface of the penis.

Whichever fixture is used, it is desirable to arrange the transducers 30 and 32 to span both sides of the dorsal blood vessel along the upper part of the penis so that they do not relatively impede the progression of ultrasound to the cavernous artery. . Finally, the transducer housing 20 may comprise a hinge at the center. The two legs, thus rotating around the housing 20, place the transducers on top of the penis, preferably in the 10 o'clock and 12 o'clock directions, for example. In any case, the direction angle is fixed at 60 °, for example.

6-7 illustrate another diagnostic test apparatus 100, which includes a transducer housing 20 similar or identical to the embodiment described above. However, the test apparatus 100 additionally includes a spring mechanism 110 to apply pressure to the lower housing 50 to engage the penis. The spring device 110 includes a compression spring 130 and is connected to an upstanding end 120 of the lower housing 50 via a connecting piece 140. The spring 130 biases the connecting portion 140 and the upright tip 120 vertically upwards, with the lower housing 50 facing the transducer housing 20 to force the penis between them. In addition to the strap 90 of the embodiment shown above, the spring 130 is in accordance with Hook's law. Therefore, the pressure between the transducer and the penis changes depending on the size of the penis and thus the spring position.

8-9 illustrate another embodiment of a transducer housing. The transducer housing 170 forms an open frame and includes longitudinally extending grooves 180 that fit snugly against the corresponding tongue member 190 of the sole transducer 200. Therefore, the transducers 200 are able to slide in the transducer housing to the desired position for each cavernous artery, if desired, for example to fit the particular patient's body. Therefore, it is possible to adjust the sole transducers laterally, even if the housing actually maintains a constant angle of incidence at about 60 ° or another desired angle.

10-13 show examples of this type of structure in more detail. The transducer 205 is supported by the transducer housing 210 and includes a longitudinally extending rail 215. Transducer 205 actually includes a respective sub-housing with a hard but bendable finger 225, allowing rider 230 to slide and engage rail 215. Fingers 225 may be pressed together while substantially releasing rider 230 from rail 215. When the pressure is released, the finger 225 quickly returns to its original position while frictionally fitting between the rider 230 and the rail 215. According to one embodiment not shown, the rail 215 and the rider 230 are substantially fixed to the side of the housing 210 which still eases the rider 230 and the rail 215 for side adjustment. ) Consists of a series of ridges or teeth paired along its length. The transducer housing 210 also includes a slot 213 to support the upstanding sidewall 55, for example as shown in the previous figure. The housing 210 and subhousing 220 may be made of plastic or similar material.

14 shows another embodiment of a transducer housing 210. Transducer housing 210 includes a central bend 240 which is fixed to achieve a substantially preferred angle, for example, 150 °. Therefore, each "leg" of the transducer housing 210 descends about 15 ° below the horizontal or other related plane. The central bend 240 is positioned about 10 o'clock and 2 o'clock on the penis, reducing the potential up and down motion that may appear in the straight transducer housing 210 without disturbing the blood vessels. Let's do it. The angle of incidence is fixed at 60 °, for example. The transducer 205 also preferably includes an arrow or similar symbol 245 to indicate the proper orientation of the transducer housing 210 relative to the patient. Thus, for example, transducer housing 210 may be arranged such that arrow 245 is aimed at the patient.

As shown in FIG. 15, according to one embodiment, the transducer 205 includes a gap 250 for supplying a gel 255 or similar negative conductive material administered by a suitable dispenser 257. do. The gap 257 must be completely filled with gel 255 to prevent air bubbles from interfering with the transmission of the ultrasonic signal. Gel 255 may be written before or after transducer 205 is inserted into transducer housing 210.

Other features of the embodiment shown in FIGS. 10-15 are as shown and discussed in the foregoing embodiment.

FIG. 16 shows an example of another diagnostic test apparatus 260 having separate transceiving transducers as described above. The test device 260 has a relatively simple structure having one or two elastic straps 265 whose ends 270 are fixed together by a fixing device 280. Strap 265 secures transducer 290, which is a transmission transducer according to one embodiment, on a preferred position, substantially on top of the surface of penis 300 relative to the cavernous artery 310. The elastic strap 265 also actually secures the transducer 320, eg, the receiver transducer, to the bottom of the penis 300 surface. According to one embodiment, the penis 300 is wrapped in a rather sticky fabric or fabric-like material to comfort the patient and secure the band and transducer in place before being tied to the band 265. The elastic band 265 is compressed or inflated according to the size change of the penis.

Of course, alternatively, instead of the four individual transducers shown in FIG. 16, the strap 265 can be used to fix only two transducers or even one sole transducer. This embodiment has a simple and inexpensive structure, although important mechanical angle adjustments are required for the desired angle of incidence and optimal beam placement.

17-18 illustrate transmit and receive converter paths 330 and 340 coupled with the transmit and receive converters 290 and 320 of FIG. 16 for two incident angles of 60 degrees and 72 degrees, respectively. The passages 330 and 340 form an intersection region 350, the size and location of which are varied depending on the angle of incidence and are arranged to cross the cavernous artery in which blood flow velocity is measured.

It is preferable that the incident angle shown in FIG. 17 is 60 degrees. When the angle of incidence increases, the Doppler frequency effect decreases, and when the angle of incidence is 90 degrees, the Doppler frequency becomes zero. On the other hand, when the angle of incidence decreases, sonic contrast energy or other energy must pass through the distant tissue before reaching the intended destination. Such progression is very attenuated and ultimately the signal is lost. It was found that the incidence angle to minimize this loss is 60 degrees.

As discussed above, the electronics combined with the selected test embodiment, when selected by a urologist or other medical practitioner, perform a wide variety of desirable calculations and present graphical representations of a wide variety of variables. Control electronics that can be used in accordance with the present invention are available from various companies. Graphs of velocity versus time in both cavernous arteries can be displayed simultaneously or sequentially at the location of the medical professional during or after the diagnosis process. In addition, the velocity is correlated with an electrocardiogram and / or pulse oximetry reading to indicate a change in blood velocity with respect to the heartbeat. The diameter scale of the penis may also be indicated and correlated.

The graphical information can be displayed on the display screen in a number of different formats. For example, the spectral distributed graphics mode displays a gray scale representing both Doppler frequencies. The larger the frequency shift, the further away from the baseline on the display screen. The statistical mean of the Doppler frequencies in the average frequency mode is indicated by colored lines, for example. In the index mode of the display, the rhythm, resistance, spectral distribution and heart rate are displayed. The maximum frequency mode displays the maximum frequency shift, for example in color. Finally, the frequency graphics mode displays a single frequency, often occurring during experimentation, again in color.

The spectral distribution, maximum frequency and average frequency display can be used simultaneously to measure the characteristics of the signal. When adjusting the transducer to measure the velocity in the cavernous artery, the maximum grayscale (spectral distribution) signal should be displayed. If the signal is of good quality, the maximum frequency display and the average frequency display should follow the form of wavelength indicated by spectroscopic analysis. The average frequency should be lower than the maximum frequency and the distance between the two frequencies should be relatively constant.

Although the test device according to the present invention can be placed anywhere on the axis of the penis, it is desirable to be as close as possible to the base of the penis during the diagnosis process, and most preferably during injection of a vasodilator or self-response. Keep it close. This placement makes it possible to perform double scanning on other parts of the penis to find weaknesses in the penis as needed. Therefore, embodiments of the present invention allow for optimal penis access, and also being located at the base increases stability. In addition, by using headphones or external speakers to increase the 'beep' sound detected when ultrasound crosses the cavernous artery, the initial position can be verified.

In a typical patient, it is correct to assume that the cavernous artery runs parallel to the surface of the penis and the actual blood flow rate can be measured. Even in the unusual case where the cavernous artery deviates from the exact parallel of the surface, medical professionals can make an accurate diagnosis according to embodiments of the present invention. Since the angle of incidence is fixed constantly during the time of diagnosis, whether it is sonic or healthy can be diagnosed in relation to the rate of rate, ie the rate of increase of blood velocity over time, without having to know the angle of incidence extremely accurately. In an embodiment of the present invention, the relative velocity calculation is independent of the angle of incidence only if the angle of incidence remains mechanically fixed and constant during the diagnostic process.

Acoustic Output Level

According to one model of continuous wave (CW), the following results are obtained.

Value W ₀ f _c Z _sp X _{-6 ′} Y _{-6 ′} EPD I _SPTA3 78 (+ 22.6 / -14.0) mW / cm ² 1.6 (+ 0.72 / -0.29) mW 7.85 MHz 11 mm 1.0 (= 0.12 / -0), 0.8 (+ 0.10 / 0) mm .76 × .38 cm

The values in parentheses are measurement errors that are calculated using the method of sum of squares, taking into account the maximum errors for stethoscopes, measurements, calculations, and incorrect positions.

Speed range

The maximum speed range detectable at the maximum Doppler frequency is as follows:

Doppler frequency at 0 ° ± 32 kHz: ± 3 m / s (± 7 cm / s)

Doppler frequency at 30 ° ± 32 kHz: ± 3.5 m / s (± 40 cm / s)

Term description

Maximum value: The maximum value given above is less than the intensity measured in water. In reducing the intensity, tissue attenuation is taken into account, and tissue attenuation is estimated at 0.3 dB / cm x MHz. Attenuation is calculated for the focal depth, ie the highest ultrasonic intensity (Z _sp ) point. The measured spatial peak instantaneous mean intensity (I _SPTA ) is reduced by the losses due to attenuation.

W ₀ : This value represents the overall acoustic power delivered by the transducer and is calculated by adding the output intensity on the ultrasound beam.

f _c : Center frequency of the transducer. This value may differ slightly from the actual operating frequency and is calculated from Fourier spectral analysis presented by the transducer.

Z _sp : Axial distance used to calculate the aerated intensity. The distance from the transducer surface at which the peak of reduced strength occurs.

X _{-6 '} Y _-6' : The size of the ultrasonic beam measured at the distance of Z _sp . This value represents the width of the beam with the boundary formed by the acoustic intensity 6 dB less than the maximum intensity.

EBD: Input beam size. Size of the ultrasonic beam at the transducer surface. The transducers have a split-D structure; The transmitting and receiving elements each have the form of a semicircle. The numbers indicate the diameter and radius of the semicircle.

Although the present invention has been described in connection with a preferred embodiment, the present invention is not limited to the embodiment. The invention includes various modifications and changes that can be readily appreciated by those skilled in the art of reading the application. Many elements of the various embodiments described above can be mixed or combined. For example, pad 38 may be used in the embodiments of FIGS. 8-9, although their use is not clearly described in the description. The thin film 40 and the border 45 may be used separately instead of pads connected as one. In addition, as described above, embodiments of the present invention may be applied to diagnostic procedures different from other parts of the body. The invention includes various modifications and changes within the spirit and scope of the invention as defined in the following claims.

Claims (24)

At least one transducer for interpreting the transmission and reception of energy and the corresponding Doppler effect to measure the blood flow velocity of the cavernous artery; A transducer housing for supporting the transducer in a substantially fixed direction relative to the penis when the transducer measures the blood flow velocity of the cavernous artery; And Mechanically coupled to the transducer housing to actually mechanically secure the transducer housing to the penis and to maintain at least one transducer in a substantially constant position relative to the cavernous artery during the impotence diagnostics. Male sound wave diagnostic device by measuring the blood flow rate in the cavernous artery of the male penis. The device of claim 1, wherein the securing device comprises a pressure ballon supported by a disposable housing to substantially maintain a constant pressure between the penis and the transducer. 2. The device of claim 1, wherein the securing device comprises a strap that wraps around the penis. 2. The apparatus of claim 1, wherein the transducers displace relative to each other to direct the transmit and receive energy to a desired position. The device of claim 1, wherein the transducer transmits ultrasonic energy. The device of claim 1, wherein the securing device includes a spring loaded adjustment device to push the device against the penis and to maintain the transducer housing in the proper position. 6. The apparatus of claim 5, wherein the transducer uses ultrasonic energy of continuous wave (CW). The device of claim 1, wherein the transducer continuously transmits and receives energy for a long time to continuously measure the blood flow rate of the penis. The device of claim 1, further comprising an acoustically conductive thin film and / or gel disposed between the transducer housing and the penis. The device of claim 1, wherein the at least one transducer consists of at least two transducers located on each cavernous artery in the penis to measure blood flow on either side of the penis. The device of claim 1, comprising at least one display device for graphically displaying the velocity of blood flow in the cavernous artery in combination with the male sonographic diagnostic system. 2. The apparatus of claim 1, wherein the transducer is comprised of a single transceiving transducer. 2. The transducer according to claim 1, wherein each transducer is supported by a sub-housing, each sub-housing is slidably supported by the transducer housing, and the transducer and the transducer sub-housing are connected to the transducer housing to direct the transmit and receive energy to the desired position. And displaceable relative to the device. 14. The transducer housing of claim 13, wherein each transducer subhousing consists of at least one rider, the transducer housing comprising at least one corresponding rail, and the rider of the transducer subhousing laterally shifts the transducer position. And slides along the rails of the transducer housing for adjustment. 15. The transducer of claim 14, wherein each transducer sub-housing includes a finger to support the rider of each transducer sub-housing, the finger being movable to disengage the rider from the transducer housing rail to enable lateral adjustment. The device characterized in that. Positioning at least one transducer in contact with the penis and allowing the transducer to be supported by the transducer housing; Fixing the transducer housing and the transducer to an appropriate position on the penis using a fixing device to maintain the transducer angular direction relative to the penis substantially fixed; And A method for diagnosing sonar in males comprising measuring the blood flow rate in the penis using energy transmitted and received by at least one transducer. The method of claim 16, further comprising the step of injecting a vasodilator into the penis, and then continuously measuring blood flow rate for a long time. 17. The method of claim 16, further comprising the step of displaying a graphical representation indicative of blood flow rate on the display device. 19. The method of claim 18, further comprising displaying an electrocardiogram or pulse oximetry output correlated with a graphical representation of blood flow rate. 17. The method of claim 16, further comprising maintaining the penis in an actual proper position using a pressure balun device. (a) measuring the rate of blood flow in at least one cavernous artery in the penis; (b) then injecting vasodilators into the penis to induce an erection response; And (c) continuously measuring the rate of blood flow in at least one cavernous artery for at least 10 minutes after vasodilator injection. 22. The method of claim 21, further comprising (d) continuously accumulating blood flow rate data for at least 10 minutes after vasodilator injection. (a) measuring the rate of blood flow in at least one cavernous artery in the penis; (b) then injecting vasodilators into the penis to induce an erection response; (c) continuously measuring the blood flow rate in at least one cavernous artery for a period of time after vasodilator injection; (d) continuously measuring the diameter of the penis over time of step (c); And (e) A method for diagnosing the sonar of male, characterized in that the step of displaying the data on the blood flow rate and the data on the penis diameter graphically and simultaneously displayed over time of step (c). At least one transducer for interpreting the transmission and reception of energy and a corresponding Doppler effect to measure blood flow rates in blood vessels; A transducer housing for supporting the transducer in a substantially fixed direction with respect to the patient when the transducer measures blood flow velocity in the vessel; And Mechanically coupled to the transducer housing to physically fix the transducer housing to the patient and to hold the at least one transducer in relation to the vessel at a substantially constant position to measure blood flow velocity in the patient's blood vessels Device.