WO1992009962A1 - Dispositif et procede de detection de la fonction erectile - Google Patents

Dispositif et procede de detection de la fonction erectile Download PDF

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Publication number
WO1992009962A1
WO1992009962A1 PCT/US1991/008965 US9108965W WO9209962A1 WO 1992009962 A1 WO1992009962 A1 WO 1992009962A1 US 9108965 W US9108965 W US 9108965W WO 9209962 A1 WO9209962 A1 WO 9209962A1
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WO
WIPO (PCT)
Prior art keywords
penile
blood flow
signals
electrical
sensor
Prior art date
Application number
PCT/US1991/008965
Other languages
English (en)
Inventor
Alan N. Schwartz
Original Assignee
Schwartz Alan N
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schwartz Alan N filed Critical Schwartz Alan N
Publication of WO1992009962A1 publication Critical patent/WO1992009962A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06Measuring blood flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/43Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4375Detecting, measuring or recording for evaluating the reproductive systems for evaluating the male reproductive system
    • A61B5/4393Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation

Definitions

  • the penis is divided into four hydraulic chambers; two corpora cavernosa, a corpus spongiosum, and a glans. Although all contain spongelike sinusoidal tissue, only the
  • corpora cavernosal sinusoids contain the venous sinusoidal occlusion mechanism.
  • the venous sinusoidal mechanism can transform the corpus cavernosum from an open to a closed chamber capable of trapping blood and thus producing
  • each corpus cavernosum is supplied by its own cavernosal artery. Cavernosal artery flow and pressure determine the competence of the erectile process. The dorsal and bulbar arteries supply blood to the skin of the penis, glans, and corpus
  • the erectile cycle can be divided into four phases: initiation, generation, maintenance, and detumescence.
  • initiation The earliest phase of erection, initiation, occurs when a
  • 25 neurochemical stimulus causes a rapid inflow of arterial blood into the corpora.
  • the sinusoids become engorged.
  • Generation occurs when the venous outflow mechanism closes.
  • Blood is then stored in the corpora cavernosal bodies.
  • the penis expands until full rigidity is achieved.
  • Maintenance occurs when the corporal bodies are fully expanded and the arterial inflow and venous outflow are in an equilibrium state such that full penile expansion and pressure are maintained.
  • Detumescence is the process whereby full erection is lost by either a decrease in arterial inflow or an increase in venous sinusoidal outflow.
  • These erection phases can be characterized by the shape of their cavernosal blood flow wave forms. Erectile dysfunction, impotence, can be caused by physiologic or psychologic factors.
  • the first category of devices measures mechanical penile events. These function by determining the rigidity or circumference of the penis. These devices most frequently measure the degree of erections a patient develops at night i 5 time during REM sleep. These devices are useful in defining whether a patient can or cannot generate a normal nighttime erection. These devices are incapable of defining vascular physiology, and cannot assign a physiologic cause in a patient who fails to achieve erection.
  • the second class of devices available can define vascular physiology. However, these devices require a technician to operate them and an injection of medication into the penis is necessary in order to induce erections and perform these tests. These tests are usually performed in
  • a patient's ability to have a normal erection may be inaccurately diagnosed in the doctor's office due to the inhibition a patient may experience because of the embarrassment when attempting to develop an erection in an office setting in
  • the present invention provides an apparatus and method for sensing and measuring penile blood flow wave forms, and for processing and evaluation of these wave forms to diagnose and categorize penile erectile function or dysfunction.
  • Non-invasive sensors preferably are Doppler piezoelectric transducers.
  • these sensors can be pulse oximetry and/or photoplethysmographic transducers in addition to, or instead of, Doppler piezoelectric transducers.
  • the electrical signals representing penile blood flow wave forms are processed by a digital signal processor (slave) and are then transferred to a host computer (master) where they are compared to normal and/or abnormal reference penile blood flow wave forms stored in memory.
  • This processing and comparison by the digital signal processor and host computer yields the subject's penile erectile function based on penile erection phase, penile blood flow systolic velocity, penile blood flow diastolic velocity, penile intracorporal pressure, penile intracorporal resistance, and penile blood oxygenation.
  • these values and wave forms are displayed on a monitor.
  • these values and wave forms are printed to create a patient report.
  • these values and wave forms are stored on an archive device for future playback.
  • the noninvasive sensors, digital signal processor, and associated memory are separable from the host computer for data gathering outside of the clinical environment.
  • a systemic (non-penile) blood flow wave form is non-invasively sensed with oximetry or photoplethysmographic transducers.
  • the subject's own real time systemic blood flow wave forms, in addition to or instead of reference penile blood flow wave forms, are thus compared to the subject's penile blood flow wave forms by the digital signal processor and host computer to yield penile erectile function.
  • FIG. 2 is a cross-section of the penile transducers of the present invention taken at line 2-2 of FIG. 1.
  • FIG. 3 is a cross-section of the penile transducers of the present invention taken at line 3-3 of FIG. 1.
  • FIG. 4 is a block diagram of the apparatus for measuring penile blood flow wave forms and for evaluation of penile erectile function.
  • FIGS. 5a, b, c, and e are schematics of the electronic circuitry of the wave form collecting and processing components of the present invention.
  • FIG. 5d is a flow chart depicting the programming of the state timing and control circuits.
  • FIG. 6 is a flow chart of the host computer examination program.
  • FIG. 7 is a flow chart of the host computer examination loop subroutine.
  • FIG. 8 is a flow chart of the event recording loop subroutine.
  • FIG. 9 is a flow chart of the digital signal processor
  • FIG. 10 is a flow chart of the Doppler data processing subroutine.
  • FIG. 11 is a graph of Doppler penile blood flow wave forms of erectile phase 0.
  • FIG. 12 is a graph of Doppler penile blood flow wave forms of erectile phase IA.
  • FIG. 13 is a graph of Doppler penile blood flow wave forms of erectile phase IB.
  • FIG. 14 is a graph of Doppler penile blood flow wave 10 forms of erectile phase 2.
  • FIG. 15 is a graph of Doppler penile blood flow wave forms of erectile phase 3.
  • FIG. 16 is a graph of Doppler penile blood flow wave forms of erectile phase 4.
  • FIG. 17 is a graph of Doppler penile blood flow wave forms of erectile phage 5A.
  • FIG. 18 is a graph of Doppler penile blood flow wave forms of erectile phase 5B.
  • FIG. 19 is a graph of Doppler penile blood flow wave 20 forms of a male having abnormal penile arterial function.
  • FIG. 20 is a graph of Doppler penile blood flow wave forms of a male having abnormal penile venous function.
  • FIG. 21 is a graph of Doppler penile blood flow wave forms of a male having abnormal penile arterial and venous •25 function. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Penile Wave Form Transducers
  • the apparatus for sensing and measuring penile blood flow wave forms and for evaluation of penile erectile function includes transducers 101, 103, 105 and 107 circumferentially located around the shaft of the penis 109.
  • transducers 101, 103, 105 and 107 are Doppler pulse wave transducers.
  • transducers 101, 103, 105 and 107 may also be pulse oximetry transducers known in the art that sense penile blood oxygenation based on the frequency of the transducer- transmitted light waves that are absorbed by the hemoglobin of the penile blood.
  • the pulse oximetry transducers may be employed either in addition to, or instead of, Doppler piezoelectric transducers. Additionally, these transducers can be photoplethysmographic transducers known in the art.
  • Doppler transducers 101, 103, 105 and 107 are piezoelectric ceramic composite transducers preferably sized and shaped to transmit preferably at 7.5MHz or 10MHz, or a range therebetween.
  • Transducers 101, 103, 105 and 107 are preferably secured in a synthetic elastomeric polymer condom ⁇ like sheath 111 that is less restrictive than a normal condom so that erectile function is not impeded.
  • a condom-like sheath of woven material either with or without elastomeric properties, may be employed. Adhesives may also be employed to secure sheath 111.
  • the transducers 101, 103, 105 and 107 can be secured to the penis 109 with an adhesive alone.
  • the above descriptions of the securing of transducers 101, 103, 105 and 107 are exemplary only, and are not intended to be exhaustive.
  • Electrical leads 113 connect the transducers 101, 103,
  • transducer select-control circuit 409 that sequences the sensing of transducers 101, 103, 105 and 107 such that only one transducer provides penile blood flow wave form data at any given time.
  • the Doppler sensing by tranducers 101, 103, 105 and 107 is thus sequenced to allow real time Doppler detection of penile blood flow wave forms.
  • transducers 101, 103, 105 and 107 The preferred number of transducers 101, 103, 105 and 107 is four, however, a fewer or greater number may be employed. When four transducers 101, 103, 105 and 107 are employed, as shown in FIG. 2, these transducers are preferably circumferentially oriented such that transducers 103 and 107 are located in the dorsal region of penis 109, nearer to transducer 105 than to transducer 101. Referring still to FIGS.
  • the penis 109 includes glans 115, two corpus cavernosa 201, cavernosal artieries 203, dorsal veins 205, dorsal arteries 207, bulbo spongiosum 209, sinusoids 211, and bulbo-urethal artery 213.
  • transducers 101, 103, 105 and 107 are shown. Note that in one embodiment the transducer, in this case 105, is oriented on penis 109 such that transducer elements 301 and 303 are oriented at a fixed angle relative to cavernosal artery 203 by wedge 305. This angular orientation of transducers 101, 103, 105 and 107 allows a Doppler estimate of the angle 0. The angle 0 is required to calculate the velocity of blood flow relative to
  • the angle ⁇ can be calculated, referring to FIG. 3, based on the following equations: cos ⁇ - a (2) d
  • the wave form collecting and processing apparatus of the present invention solves for cosine ⁇ based on equation 4 where a is a known distance and c and d are transducer measured distances. Then, the cosine & value from equation 4 is employed in equation 1 to solve for the velocity of the blood flow v relative to Doppler frequency W d . 11 It is readily apparent, however, that other methods of ultrasound acquisition besides Doppler ultrasound known in the art may be employed.
  • the apparatus for measuring penile blood flow wave forms and for evaluation of penile erectile function optionally includes systemic wave form transducers (e.g., photoplethysmography or oximetry sensors known in the art) to measure the subject's systemic (as opposed to penile) blood
  • systemic wave form transducers e.g., photoplethysmography or oximetry sensors known in the art
  • This comparison may be in addition to, or instead of, the comparison of the subject's penile blood flow wave forms with reference penile blood flow wave forms stored in host computer memory.
  • FIGS. 4 and 5a-d the apparatus for collecting and processing penile blood flow and systemic blood flow wave forms is now described.
  • RF power splitter/combiner 403, RF 25 transmitter control circuits 405, transducer select control circuit 409, RF receiver and time gain circuits 411, state timing and control circuits 421, receive depth track and hold amplifier and analog to digital converter 431, and master clock 453 comprise wave form collecting and processing components 401 further detailed in FIGS. 5a-d.
  • A. RF Power Splitter/Combiner Referring now to FIG.
  • the radio frequency power splitter/combiner circuit 403 of wave form collecting and processing components 401 receives the transmitter RF burst from RF transmitter control circuits 405 and impedance matches the transmit burst to the active transducer elements 101, 103, 105, and 107 by passing the signal out the coaxial cable 407 to the transducer select-control circuit 409.
  • the RF receiver and time gain control circuits 411 are impedance matched by the splitter/combiner 413 such that, during transmit, the load presented by the connector 417 is high, thus preventing transmitter power loss from connection 415 into connection 417 and into RF receiver gain control circuit 411.
  • the coaxial cable 407 of the power splitter/combiner 403 matches the characteristic impedance of the active transducer elements 101, 103, 105, and 107 for both transmit and receive.
  • the circuitry of power splitter/combiner 403 employs steering diodes and blocking diodes in combination with RF transformer coupling, designed to match the characteristic impedances of each individual port of power splitter/combiner 403.
  • the RF signal used to develop the acoustic energy transmitted by the active transducer elements 101, 103, 105, and 107 is produced by RF transmitter control circuits 405.
  • the transmitter clock 419 is provided by the state timing and control circuit 421. The frequency of this clock would range between 5.0 MHz and 10.0 MHz. Optimally, the frequency of réelle 5 this signal will be 7.5 MHz or 10 Mhz.
  • the RF transmitter and control circuits 405 will logically 'and' the transmit clock 419 with the transmit gate 423 to generate a gated RF burst of 4 cycles of a 7.5 MHz clock to give a theoretical depth resolution of approximately l/2mm, and a practical 10 resolution of 1mm depth discrimination.
  • the digital signal processor 425 sets the transmit power level. This circuit sets the high voltage applied to the transmit output drive circuit. The selection of a power level is done by direct digital control, such as a digital to 15 analog converter to a high voltage regulator bias circuit.
  • the RF receiver and time gain control circuits 411 are impedance matched to the input signal connection 417. To protect the RF-preamplifier, the signal present on connection
  • 20 417 is clipped at a diode conduction potential (i.e., 0.6V).
  • the second stage of RF gain is used to amplify the input signal on connection 417 to a level approximately +60dB.
  • the signal is split into two identical RF signals with significant protection against cross coupling of a signal
  • the two isolated amplified RF signals are down converted to detect useful Doppler information.
  • the detection can be performed by sampling the RF signal at the frequency of the transmit clock 419.
  • the transmit clock 419 is used to detect the Doppler signal content in one of the two isolated amplified RF signals.
  • the second isolated amplified RF signal is mixed against a 90 degree phase shifted version of the transmit clock 419.
  • the lead/lag relationship of the signals allows the digital signal processor 425 to discriminate between a UP Doppler shift (blood flow toward the transducer) , and a DOWN Doppler shift (blood flow away from the transducer) .
  • Mixing and low pass filtering converts the Doppler signal inputs at connection 417 (into RF receiver and gain control circuit 411) to the audio bandwidth Doppler signals 427 and 429.
  • the corner frequency (cut-off frequency) of the low pass filters used to receive the audio bandwidth Doppler signals 427 and 429 must be as low as possible to eliminate aliasing of out-of-band signals, as well as to reduce the noise bandwidth of the recovered Doppler information. However, it is necessary to maintain sufficient signal bandwidth in the recovered bandwidth Doppler signals 427 and 429 to discriminate between signals arriving from different anatomical depths in the body. Discriminating Doppler data received to within a 1mm depth of anatomical origin requires a low pass filter that is matched to the RF transmit burst.
  • An adjustable low pass filter allows the digital signal processor 425 to determine the depth of the blood vessel in order to correctly determine the angle 0 of the transducer 101, 103, 105 and 107 relative to the blood vessel examined. This Doppler angle correction is discussed in further detail above in conjunction with the description of transducers 101, 103, 105 and 107, and below in conjunction with the discussion of the wave form collecting and processing apparatus operation. Once the Doppler angle is determined, the cut-off frequency of the low pass filter can be lowered to reduce the noise bandwidth of the RF receiver and time gain control circuits 411. The anatomy of the penis dictates that no Doppler interference of the vessel blood flow occurs by loss of depth discrimination for the transducer elements 103, 105 and 107.
  • this element 101 does not have its associated low pass filter bandwidth decreased.
  • the ability of the transducer to discriminate between multiple vessels and their associated Doppler signal prevents reducing the low pass filter's corner frequency.
  • T&H Receive Depth Track and Hold Amplifier
  • A/D Converter A/D Converter
  • the Doppler signal depth detection is accomplished by a track and hold (T&H) amplifier and analog to digital converter 431.
  • T&H track and hold
  • the 'hold' is determined by the depth gate 433. State timing and control circuitry 421 generates the depth gate 433 in increments of 1.25 microseconds; this time represents 1mm of sound travel in the acoustic model of body tissue.
  • the digital signal processor 425 is responsible for positioning the depth gate over the region of maximum blood flow. Once positioned over the region of maximum blood flow, the position of the 'hold' gate of receive depth track and hold amplifier and analog to digital converter 431 will remain constant, allowing the digital signal processor 425 to perform pattern recognition algorithms on the Doppler received signal.
  • the signal 'held' by the T&H amplifier is sampled by the A/D converter of 431 and is synchronized by the A/D GO pulse 434 that is generated by the state timing and control circuit 421.
  • This digital representation of the analog receiver's Doppler signal content corresponds to the acoustic Doppler energy of the blood cell scatter in the sample volume, 1mm in size, at a depth in the body determined by the depth gate 433.
  • the signals 427 and 429 must be simultaneously sampled by the T&H amplifier of 431.
  • the simultaneous sampling preserves the phase relationship of the signal 427 relative to signal 429.
  • This information is required by the digital signal processor 425 in order to resolve blood flow direction relative to the transducer 101, 103, 105 and 107.
  • the A/D converter of 431 can be multiplexed between the analog 'held' signal output of the T&H amplifier of 431 or separate A/D converters can be used to sample the T&H outputs independently.
  • the essential feature is the preservation of the phase information of signal 427 and signal 429 in the digital data passed to the digital signal processor 425 on the analog interface bus 435.
  • a standard systemic wave form measurement device 437 such as a photoplethysmograph equipped with an A/D converter 439 to digitize the detected flow output, provides additional information to digital signal processor 425.
  • the systemic flow wave form of blood flow (in the hand or ear of the subject patient) is correlated by the digital signal processor 425 to the blood flow wave form of the penis.
  • the digital systemic blood flow data is passed to the digital signal processor 425 on the interface bus 441.
  • a penile depth gate sample marker 443 is used to encode the digital data passed on the interface bus 441 from the A/D converter 439. This marker allows the digital signal processor 425 to synchronize, in time, the flow data from transducers 101, 103, 105 and 107 on the penis and systemic blood flow transducer on the hand or ear.
  • DSP Digital Signal Processor
  • the digital signal processor 425 is a slave computer designed for mathematical calculations of Fast Fourier transforms, autocorrelation, crosscorrelation, IIR (Infinite Impulse Response) filters, FIR (Finite Impulse
  • Digital signal processor 425 preferably includes a slave central processor unit chip which may be the "DSP 32C” chip manufactured by American Telephone and Conduct, Inc., or the "TMS 320C25” chip manufactured by Texas Instruments, Inc. Digital signal processor 425 also includes a random access memory and has buffer chips and control logic known in the art.
  • the digital signal processor 425 controls the depth position of the active transducer 101, 103, 105 or 107 with depth gate 433.
  • Digital signal processor 425 sequences the active transducer elements 101, 103, 105 or 107 positioned on the penis, as well as managing the interface bus 441, A/D interface bus 435, and host computer communication bus 445.
  • the digital signal processor algorithms (detailed below) analyze the Doppler flow information and make use of spectral evaluation of flow to correlate the subject penile blood flow wave form data to that of normal penile blood flow wave form data. Both raw data and processed, analyzed data is stored in a RAM memory in digital signal processor 425 and, after a predetermined data collection time period, can be passed to the host computer 449 over the host interface bus 445 for further processing.
  • the host interface bus 451 allows system synchronization between the host computer 449, digital signal processor 425, and master oscillator timing 451 from master clock 453.
  • the time critical nature of real-time signal processing is greatly enhanced by synchronizing all system components to a single master clock 453.
  • Master clock 453 and state timing and control circuits 421 produce coherent digital noise. Coherent noise can be effectively processed by the digital signal processor 425 without degrading the analog Doppler signal information.
  • Asynchronous digital noise can cross modulate with analog signals to produce false Doppler information. Once false Doppler modulation is injected into the analog signal path, it is difficult for the digital signal processor 425 to discriminate Doppler data sensed by transducers 101, 103, 105 and 107 from the false Doppler data.
  • the host computer 449 central processing unit, ROM, RAM
  • the data processed by the digital signal processor 425 is displayed on monitor 455.
  • Essential penile blood flow wave form data is saved in archive device 457 (e.g., hard disk drive, optical disk drive, magnetic tape drive, or floppy drive).
  • a printer 459 creates permanent wave form data records.
  • the monitor 455, archive device 457, and printer 459 are connected to the host computer 449 on standard interface busses 461.
  • the digital signal processor 425 and associated wave form collecting and processing components 401 can be disconnected from host computer 449 at the host interface bus 445 for more convenient subject examination.
  • the digital signal processor 425 and associated wave form collecting and processing components 401 can thus perform the Doppler blood flow signal processing independent of host computer 449, and are subsequenctly reconnected to the host computer 449 through host computer interface bus 445.
  • the data storage device 457 is modified.
  • the data storage device 457 is connected directly to the digital signal processor 425 so that all data is recorded as permanent record of the subject's blood flow wave forms. A complete record of all spectral data is needed to allow physician review of the entire examination.
  • 103, 105 and 107 are standard ceramic piezoelectric elements.
  • the transformers on the output of each relay to the individual transducer elements transform the capacitive load of the transducer element to a 50 ohm real impedance and connect to the relays in the transducer 5 select-control circuits 409.
  • the transducer select signal 509 energizes a single relay switch.
  • the choice of which transducer is enabled is digitally determined by the digital I/O control circuit of digital signal processor 425.
  • the transducer selection is determined by an acquisition software
  • the output of the select-control circuits 409 is directly connected to the power splitter/combiner 403.
  • the power splitter/combiner 403 impedance matches the transmitter output drive to the ceramic piezoelectric crystal selected.
  • the power splitter must impedance match the amplifiers of the RF receiver and time gain control circuits 411 input impedance to the active transducers 101, 103, 105 and 107. Note that the transducers 101, 103, 105 and 107 are attached electrically to the RF receiver and time gain control
  • receiver and time gain control circuits 411 are not functional, and the shunting diodes on the input of the receiver protect the receiver's input circuit from the high voltage developed during transmit.
  • the receiver input transformer 511 boosts the RF signal as well as isolates the RF receiver and time gain control circuits 411 from the transmission line 417.
  • the bias power of the RF receiver and time gain control circuits 411 is indicated by +v and -v.
  • RF pre-amplifier 513 an N channel JFET, is used for RF gain.
  • the common collector amplifier 515 impedance matches the output of the RF pre- amplifier 513 to the input of TGC amplifier 517.
  • TGC amplifier 517 a dual gate MOSFET, has the RF signal applied to the 'signal-input', gate-1, and the gain bias voltage applied to gate-2.
  • the gain bias voltage is developed by the TGC digital-to-analog converter and filter circuit. This voltage is increasing the time from off at transmit in order to blank the transmit burst to a maximum voltage gain at the depth of the receiver gate.
  • Emitter amplifier 519 isolates the drain output of TGC amplifier 517 from the RF channel-splitter-transistors 521 and 523.
  • RF-1 and RF-2 signals are identical in phase and amplitude. The processing of these signals is continued in FIG. 5b. Similarly, the transmitter signal path is described in FIG. 5d.
  • the signals RF-1 and RF-2 are synchronously sampled by RF channel-splitter-transistors at a sample clock of the same frequency as the RF component of the transmitter burst.
  • RF channel-splitter-transistor circuitry 523 samples signal RF-2.
  • An identical circuit 521 23 (not shown) to 523 samples signal RF-1 with a 90 degree phase shift.
  • the transmitter is 7.5MHz.
  • the sampler signal is applied to circuit 525 under control of the state timing and control circuits 421.
  • the phase of the 5 sample clock used to select 525 is identical to the transmit clock. But, the signal used to select 521 is phase shifted by 90 degrees to preserve the lead-lag nature of the Doppler detected signal.
  • the detected Doppler signal is coarsely filtered 10 and buffered by buffer amplifier 527.
  • the essential features of the low pass filter are 72dB of dynamic signal range from the pass band to the stop band, and signifcant anti-alias filtering of the low pass filter's 15 internal clock to prevent degrading the Doppler signal that is processed by the low pass filter.
  • the opto-isolation circuit 531 in the digital path between digital signal processor 425 and the low pass filter of 431 is used to suppress digital noise from digital signal 20 processor 425.
  • the isolation is needed to prevent the degradation to the Doppler signal path by digitally modulated noise currents.
  • a second opto-isolation circuit 533 is located between digital signal processor 425 and state timing and control circuits 421. • 25
  • the audio band-width outputs I and Q contain the detected Doppler signal.
  • the phase relationship of I to Q indicates the blood flow direction of the detected signal relative to the transducer element. The further processing of these signals is indicated on FIG 5c.
  • the Doppler detected signals I and Q are sampled at a time delay from transmit that corresponds to the round trip speed of sound in a penis tissue of sample depth D.
  • This time delay is the depth gate, generated by the state timing and control circuit 421.
  • the simultaneous depth sample signal is held in the track and hold amplifier 535 of receive depth track and hold amplifier and analog/digital convertor 431.
  • the held signal levels are multiplexed to the output amplifier and converted by the A/D converter 537 of 431.
  • the PRF pulse repetition frequency
  • the PRF pulse repetition frequency of the transmitter determines the rate the depth gate is sampled.
  • One receive signal pair is processed per transmit burst.
  • the PRF is of sufficient duration to allow the round trip propagation of the transmit burst relative to the blood vessel examined.
  • This PRF timing can be fixed for a maximum usable signal depth, or adjustable, based on the depth needed to sample a specific vessel. If PRF is made adjustable, the detected Doppler shifted signal is compensated based on the PRF used at any specific depth. If the PRF is fixed, the Doppler shift is determined 'constant' for all depths evaluated. The present embodiment employs a fixed PRF for all depths.
  • the state timing and control circuits 421 has a timing circuit that is a logic sequence. The timing of the logic sequence is determined by the resolution required in the Doppler detected signal. The logic sequence is driven by master clock 453. The specific implementation to this circuit is realized by using standard Boolian logic design. Referring specifically to FIG. 5d, the flow chart depicts in detail the programming of the state timing and control . 5 circuits 421.
  • Opto-isolation circuit 539 isolates the A/D digital output to prevent digital noise feedback from the digital signal processor signal bus 435.
  • the RF transmitter control 10 circuit 405 is digital.
  • the digital signal processor 425 in conjunction with transmitter pulse counter 541 sets the number of cycles of the transmit clock 419 that are used to create the burst.
  • the number of transmit clock cycles determines the bandwidth of the RF burst, and the sample 15 resolution of the depth gate.
  • the digital signal processor 425 can employ the Doppler received signal-to- noise as a feedback input to adjust the transmitter signal for the specific blood vessel being examined.
  • the power level of the transmit voltage is also adjustable.
  • the digital signal processor 425 sets the DC voltage applied to the RF transmitter control circuits 405 power driver output by adjusting programmable attenuator 543 • 25 and power source 545 from a minimum power level of approximately 60 VDC. Again, the digital signal processor 425 evaluation of signal-to-noise in the received signal determines the power level chosen for the vessel examined. Note that the transmitter signal of the RF transmitter control circuit 405 that is used to excite the transducer ceramic element is flexible. The signal is modifiable under software control of the digital signal processor 425. Thus, both simple transducer excitation and complex excitation are achievable. The specific excitation signal transmitted can be dynamically determined, as necessary, to optimize the overall instrument's sensitivity to penile blood flow.
  • the wave form collecting and processing apparatus of the present invention employs the below detailed software program to process blood flow wave form data.
  • the software programming of the ditigal signal processor 425 and the host computer 449 is comprised of a host computer examination program (FIG. 6), host computer examination loop subroutine (FIG. 7), event recording loop subroutine (FIG. 8), digital signal processor Doppler flow examination program (FIG. 9), and Doppler data processing subroutine (FIG. 10).
  • FIG. 6 is a flow diagram of the host computer (449) examination program.
  • the host computer 449 initializes peripheral archive devices, tests the user interface, and tests for the on-line presence of digital signal processor (slave) 425.
  • the digital signal processor's software is downloaded for real time patient examination, and the host computer 449 checks for a ready signal from digital signal processor 425 before continuing.
  • Block 605 is a decision block that inquires whether the subject is ready for examination. If the patient is ready, at block 607 the examination clock is set to run for a predetermined time period.
  • Block 611 is a decision block that inquires whether the examination is completed. If the examination is not completed, block 609 is repeated. If the examination is completed, the data from the digital signal processor 425 is, at block 613, analyzed and compared to reference penile blood flow wave forms stored in memory in host computer 449.
  • Block 615 data is saved in a permanent file in archive device 457.
  • a patient report print ⁇ out is generated by printer 459.
  • Block 619 ends the examination.
  • FIG. 7 is a flow diagram of the host examination loop subroutine 609.
  • host computer 449 waits for Doppler penile blood flow wave form data from the digital signal processor (slave) 425.
  • the digital signal processor data, raw transducer data, active transducer number and the time of the data run are all saved in the archive device 457.
  • Block 705 is a decision block that inquires whether penile blood flow wave form processed by digital signal processor 425 is equal to erectile phase 0. If the data is equal to phase 0, at block 707, the data is saved in a buffer of size 3. If the buffer already contains three phase 0 data events, the oldest one is dumped. Block 707 leads to block 701, above.
  • decision block 709 will then inquire whether the buffer has three events. If the buffer does not have three events, all phase 0 data is flushed from the buffer at block 715 and the program goes to block 701. If the buffer has three events, the three phase 0 events are saved and the non-phase 0 event is also saved. The program then proceeds to event recording loop subroutine 713 discussed further in conjunction with FIG. 8. From event recording loop subroutine 713, and program goes to block 701 via block 715, discussed above.
  • FIG. 8 is a flow diagram of the event recording loop subroutine 713.
  • host computer 449 waits for the digital signal processor 425 to process the penile blood flow profile for the active transducer 101, 103, 105 or 107.
  • archive data is saved in the archive device 457 and data is saved to the patient data file for event processing and final examination report.
  • Block 805 is a decision block that inquires whether the digital signal processor calculated event was a phase 0 event. If the event was not a phase 0 event, at block 809 the phase 0 event counter is cleared, and the program goes to block 801, above.
  • Decision block 811 inquires whether the phase 0 event is the third phase 0 event in succession. If the event is the third phase 0 event in succession, the event recording 10 subroutine loop ends at block 813.
  • FIG. 9 is a flow diagram of the digital signal processor Doppler flow examination program.
  • Block 901 tests the host 15 computer's input/output devices and tests the noise level of each Doppler transducer 101, 103, 105 and 107.
  • a ready to process message is sent to host computer 449 at block 903.
  • Block 905 is a decision block that inquires whether to begin, based on host computer command. If the program is not 20 to begin, the program goes to block 903, above. If the program is to begin, the program goes to block 907 where the transducer 101, 103, 105 or 107 is selected, the transducer power is adjusted, the depth of maximum blood flow is ascertained, cosine 0 is calculated, and the low pass filter -25 is adjusted for best signal-to-noise.
  • Block 911 sends the examination results to host computer 449.
  • Block 913 is a decision block that inquires whether the examination is over. If the examination is not over, the program proceeds to block 907, above. If the examination is over, the program proceeds to block 915, which shuts off transducers 101, 103, 105 and 107 and ends the digital signal processor DSP Doppler flow examination program.
  • FIG. 10 is a flow diagram of the Doppler data processing subroutine 909.
  • Block 1001 performs Fast Fourier transform/spectrogram on the Doppler time series data.
  • Block 1003 reads the data from the optional systemic blood flow transducer.
  • the erectile phase 0, IA, IB, 2, 3, 4, 5& or 5B is ascertained based on blood flow wave form parameters.
  • Block 1009 exits the process Doppler data subroutine. Note that the data saved in the present subroutine is passed to host computer 449, and the memory reserved for this subroutine's data collection is reused for the next data event. Penile Blood Flow Wave Form Data
  • penile blood flow wave forms for normal and erectile dysfunctional males are shown.
  • the above wave forms are exemplary of reference penile blood flow wave forms stored in memory of the host computer 449 of the present invention for comparison with the subject's penile blood flow wave forms, as discussed above.
  • the above wave forms are exemplary of the subject's penile blood flow wave forms sensed by penile transducers 101, 103, 105 and 107 that are subsequently compared to the reference penile blood flow wave forms by the present invention, as discussed above.
  • the penile blood flow wave forms of FIGS. 11 through 21 were based on empirical data collection under the following operating conditions.
  • Doppler sensors having the above described operational parameters of penile transducers 101, 103, 105 and 107 in their Doppler measurement embodiment were manually placed adjacent to the subject's penis for penile blood flow data collection. It is readily apparent, however, that pulse oximetry transducers could also be employed.
  • FIGS. 11 through 21 show arterial blood flow into the two corpus cavernosa 201 by cavernosal arteries 203. While cavernosal arterial blood flow is analyzed in FIGS. 11 through 21, it is readily apparent that the present invention can also measure and process penile blood flow wave forms based on venous blood flow and bulbo-urethral 213 or dorsal arterial 207 blood flow.
  • phase 0 of FIG. 11 shows normal penile function
  • the penis is flaccid and blood flow is negligible.
  • phase IA of FIG. 12 shows normal penile function
  • the corpus cavernosum is contracted (low volume) and inelastic. This is because of increased tone in the perisinusoidal smooth muscles.
  • pretumescent intracorporal pressure is low, resistance to arterial inflow is high.
  • penile blood flow appears to be shunted away from the corpora cavernosa and toward the glans, skin, and urethra.
  • Phase IA denotes the transition between undetectable and continuous blood flow.
  • Blood flow progresses from zero flow or intermittent flow to pulsatic flow, with increasing systolic and diastolic velocities. At the beginning of this phase, the initiation of systolic flow is gradual. By the end of the phase, the initiation of systolic flow is rapid. The total flow measured by integration of the wave form increases during this phase from near zero to near maximum. The flow pattern of this phase is commonly detected in both functional and dysfunctional males (see FIGS. 12 and 19-21).
  • phase IB of FIG. 13 shows normal penile function
  • cavernosal artery flow wave forms and velocities are influenced by both cavernosal artery vasodilatation and changing intracorporal pressure.
  • Cavernosal artery flow evolves in response to these dynamic events.
  • the cavernosal artery dilates and the intracorporal resistance is minimal.
  • Continuous flow through the entire cardiac cycle is the key characteristic of this phase IB.
  • Systolic flow is maximum or near maximum. Diastolic flow is maximum. The onset of the systolic inflow is rapid, and the total flow, by wave form integration, is near maximum.
  • phase 2 of FIG. 14 shows normal penile function
  • Phase 2 of FIG. 14 occurs as the sinusoids fill and the venous sinusoidal occlusion mechanism closes. Blood then becomes trapped within the corpora cavernosa. Intracorporal pressure and resistance increase.
  • diastolic inflow decreases. The onset of increased intracorporal resistance is heralded by the dicrotic notch and a decrease in end- diastolic velocity. The diastolic velocity continues to diminish as intracorporal pressure increases. This decrease in diastolic velocity and increase in intracorporal pressure is characteristic of this phase 2.
  • Systolic flow is near maximum and its onset is rapid. The length of the systolic flow cycle begins to shorten. The total flow, as measured by integration, decreases with the decreasing diastolic flow (due to increased intracorporal pressure) . While functional males progress to phase 2, males with severe venous sinusoidal leaks (such that intracorporal pressure is low) most often do not progress past this phase. However, males with venous abnormalities that allow higher intracorporal pressure, as well as males with arterial abnormalities, progress past this phase (see FIGS. 14 and 19-21).
  • phase 3 of FIG. 15 shows normal penile function
  • intracorporal pressure is equal to peak diastolic pressure and the diastolic signal will approximate zero.
  • Blood cannot be pumped into the corpora cavernosa during diastole when the intracorporal pressure exceeds the peak diastolic pressure in the cavernosal artery.
  • inflow is restricted to systole.
  • Systolic velocity is near maximal.
  • the length of the systolic cycle continues to shorten. The total flow continues to diminish.
  • Males with minimal sinusoidal leakage and/or minimal arterial insufficiency as well as normal males progress to phase 3 (see FIGS. 15 and 19-21).
  • phase 5 of FIGS. 17 and 18 (showing normal penile function) , is characterized by the eventual loss of both systolic and diastolic flow signals.
  • the first half of this phase, 5A (FIG. 17) is defined by the loss of both forward systolic and reversed diastolic flow components.
  • Phase 5B (FIG. 18), the second half of phase 5, is the end stage of the flow cycle and is defined by loss of both systolic and diastolic flow. All flow ceases when intracorporal pressure equals or exceeds peak systolic velocity. Phase 5 only occurs in normal males, but not all normal males consistently progress to phase 5 (see FIGS. 17, 18 and 19-21).
  • mean systolic occlusion pressure (mean SYSTOP) maximal systolic velocity and maximal diastolic velocity are shown as a function of systolic occlusion pressure (SYSTOP).
  • SYSTOP denotes the cessation of cavernosal flowduring erection.
  • the above tabulated SYSTOP andmean SYSTOP pressures may bemeasured through the above described use of an invasive needle-based pressure transducer, and the infusion of saline through another needle inserted in the subject's penis (note that an individual may also evidence SYSTOP naturally during full erection) .
  • Table 1 shows a correlation between SYSTOP and both maximal systolic velocity and maximal diastolic velocity. This correlation supports the use of maximal systolic velocity and maximal diastolic velocity to predict arterial integrity (higher velocity and higher SYSTOP pressure denoting greater integrity) .
  • the present invention can predict arterial integrity based on storage of the above SYSTOP pressure, maximal systolic velocity and maximal diastolic velocity of Table 2 in memory for processing by digital signal processor 425 and by host computer 449 with subject wave form data received by penile transducers 101, 103, 105 and 107.
  • mean intracorporal pressure, mean peak systolic velocity, time of systolic cycle and mean peak diastolic velocity are shown as a function of penile erection phases in normal males, as shown in FIGS. 11 through 18.
  • a key aspect of the present invention is the above 5 correlation between mean intracorporal pressure and both penile erection phase and penile blood flow wave form.
  • Storage of the above intracorporal pressure empirical data in memory for processing by digital signal processor 425 and by host computer 449 with wave form data received by penile 0 transducers 101, 103, 105 and 107 from the subject allows the practitioner to ascertain intracorporal pressure without the needle-based pressure transducers inserted in the subject penis.
  • the digital signal processor 425 and host computer 449 can readily derive intracorporal resistance 5 (intracorporal pressure (mmHg)/flow velocity ml per min)) once intracorporal pressure and flow velocity are obtained.
  • FIGS. 19-21 showing abnormal wave form data.
  • males with bilateral severely abnormal cavernosal arteries and normal venous sinusoidal occlusion mechanisms demonstrate decreased peak systolic velocities and an erection pattern to phase 1 or 2.
  • Males with intermediate cavernosal arteries and normal venous sinusoidal occlusion mechanisms have a lower than normal systolic velocity but may demonstrate all phases 1-5, but with a temporal sequence progression that is longer than that of normal males.
  • males with abnormal arteries have lower systolic and diastolic flow velocities, and lower total flow. Also, the wave form will generally not progress to reversed diastolic flow.

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Abstract

L'invention décrit un dispositif et un procédé servant à détecter et mesurer les formes d'ondes du flux sanguin pénien, ainsi qu'à évaluer la fonction érectile pénienne en se basant sur ces formes d'ondes. On fixe au pénis des détecteurs non invasifs tels que des transducteurs à impulsions piézoélectriques ou des détecteurs d'impulsions tels que des transducteurs à impulsions piézoélectriques ou des transducteurs à impulsions oxymétriques (103, 105, 107), produisant des signaux électriques représentant les ondes du flux sanguin pénien. Ces signaux électriques sont conditionnées par un processeur de signaux numériques (asservi) (401) et un ordinateur central (pilote) (449), ainsi que par des programmes associés. Le conditionnement des ondes du flux sanguin pénien comprend la comparaison des ondes du flux sanguin pénien du sujet en temps réel par rapport aux ondes du flux sanguin pénien mémorisées, afin de produire la fonction érectile pénienne en se basant sur la phase d'érection du pénis, les vitesses systoliques et diastoliques du flux sanguin, la pression intracorporelle, la résistance intracorporelle et/ou l'oxygénation sanguine. Ces valeurs et les formes des ondes sont affichées sur un moniteur et mémorisées en vue d'une lecture ultérieure.
PCT/US1991/008965 1990-11-30 1991-11-29 Dispositif et procede de detection de la fonction erectile WO1992009962A1 (fr)

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2726457A1 (fr) * 1994-11-08 1996-05-10 Lavoisier Pierre Procede de mesure concernant la rigidite d'un penis et dispositif pour la mise en oeuvre de ce procede
EP0806174A1 (fr) * 1996-05-09 1997-11-12 Laborie Medical Technologies, Inc. Procédé et appareil de mesure du flux sanguin artériel et veineux dans des appendices du corps
EP0928158A1 (fr) * 1996-08-09 1999-07-14 Urometrics, Inc. Systeme diagnostiquant l'impuissance masculine a l'aide d'ultrasons
US6251076B1 (en) 1997-08-01 2001-06-26 Urometrics Inc. Male impotence diagnostic ultrasound system
US6485408B2 (en) * 2000-03-14 2002-11-26 Meditron As Erection aid
WO2003022188A1 (fr) * 2001-09-07 2003-03-20 Johannes Hartmann Preservatif dote d'un systeme de stimulation electrique des partenaires sexuels
GB2392242A (en) * 2002-06-14 2004-02-25 Electrode Company Ltd Apparatus with multiple pulse-oximetry sensors
CZ299051B6 (cs) * 2004-03-16 2008-04-09 Saglena@Jan Merítko erektilní funkce
WO2008064195A1 (fr) * 2006-11-20 2008-05-29 Brian Osterberg Préservatif comportant un appareil de transmission
WO2008092264A1 (fr) * 2007-02-02 2008-08-07 Urodynamix Technologies Ltd. Systèmes et procédés permettant de surveiller la fonction érectile et de diagnostiquer une dysfonction érectile
WO2010059064A1 (fr) * 2008-11-21 2010-05-27 Vibrotron As Procédé et moyen d'amélioration d'érection
US8877508B2 (en) 2007-10-30 2014-11-04 The Invention Science Fund I, Llc Devices and systems that deliver nitric oxide
US8980332B2 (en) 2007-10-30 2015-03-17 The Invention Science Fund I, Llc Methods and systems for use of photolyzable nitric oxide donors
WO2017088217A1 (fr) * 2015-11-25 2017-06-01 Cirq Materials Limited Dispositif d'assistance de trouble de l'érection à stimulation pénienne à base de matériau intelligent
US10080823B2 (en) 2007-10-30 2018-09-25 Gearbox Llc Substrates for nitric oxide releasing devices
CN111938624A (zh) * 2020-08-18 2020-11-17 四川安雅仕智能医疗科技有限公司 一种可监测阴茎血流量的物联网传感器装置

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CH671505A5 (en) * 1986-09-17 1989-09-15 Stefan Gabler Diagnostic appts. for inadequacy of leg veins - consists of inner cylinder and outer cylinder with grip ring
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Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2726457A1 (fr) * 1994-11-08 1996-05-10 Lavoisier Pierre Procede de mesure concernant la rigidite d'un penis et dispositif pour la mise en oeuvre de ce procede
EP0806174A1 (fr) * 1996-05-09 1997-11-12 Laborie Medical Technologies, Inc. Procédé et appareil de mesure du flux sanguin artériel et veineux dans des appendices du corps
EP0928158A1 (fr) * 1996-08-09 1999-07-14 Urometrics, Inc. Systeme diagnostiquant l'impuissance masculine a l'aide d'ultrasons
EP0928158A4 (fr) * 1996-08-09 1999-12-08 Urometrics Inc Systeme diagnostiquant l'impuissance masculine a l'aide d'ultrasons
US6251076B1 (en) 1997-08-01 2001-06-26 Urometrics Inc. Male impotence diagnostic ultrasound system
US6485408B2 (en) * 2000-03-14 2002-11-26 Meditron As Erection aid
WO2003022188A1 (fr) * 2001-09-07 2003-03-20 Johannes Hartmann Preservatif dote d'un systeme de stimulation electrique des partenaires sexuels
GB2392242A (en) * 2002-06-14 2004-02-25 Electrode Company Ltd Apparatus with multiple pulse-oximetry sensors
CZ299051B6 (cs) * 2004-03-16 2008-04-09 Saglena@Jan Merítko erektilní funkce
WO2008064195A1 (fr) * 2006-11-20 2008-05-29 Brian Osterberg Préservatif comportant un appareil de transmission
WO2008092264A1 (fr) * 2007-02-02 2008-08-07 Urodynamix Technologies Ltd. Systèmes et procédés permettant de surveiller la fonction érectile et de diagnostiquer une dysfonction érectile
US10080823B2 (en) 2007-10-30 2018-09-25 Gearbox Llc Substrates for nitric oxide releasing devices
US8877508B2 (en) 2007-10-30 2014-11-04 The Invention Science Fund I, Llc Devices and systems that deliver nitric oxide
US8980332B2 (en) 2007-10-30 2015-03-17 The Invention Science Fund I, Llc Methods and systems for use of photolyzable nitric oxide donors
CN101848688A (zh) * 2008-11-21 2010-09-29 维布罗特隆公司 用于增强勃起的方法和装置
US8628466B2 (en) 2008-11-21 2014-01-14 Orbus As Method and means for erection enhancement
EA019052B1 (ru) * 2008-11-21 2013-12-30 Орбус Ас Способ и средство усиления эрекции
CN101848688B (zh) * 2008-11-21 2013-09-18 奥尔巴斯公司 用于增强勃起的方法和装置
WO2010059064A1 (fr) * 2008-11-21 2010-05-27 Vibrotron As Procédé et moyen d'amélioration d'érection
WO2017088217A1 (fr) * 2015-11-25 2017-06-01 Cirq Materials Limited Dispositif d'assistance de trouble de l'érection à stimulation pénienne à base de matériau intelligent
CN108697524A (zh) * 2015-11-25 2018-10-23 Cirq科技有限公司 基于智能材料的阴茎刺激勃起功能障碍辅助设备
US10813829B2 (en) 2015-11-25 2020-10-27 Cirq Technologies Limited Smart material based penile stimulation erectile dysfunction assistance device
CN111938624A (zh) * 2020-08-18 2020-11-17 四川安雅仕智能医疗科技有限公司 一种可监测阴茎血流量的物联网传感器装置
CN111938624B (zh) * 2020-08-18 2023-10-24 四川康励智慧医疗科技有限公司 一种可监测阴茎血流量的物联网传感器装置

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