Patent Publication Number: US-2023157603-A1

Title: Pressure sensor array for urodynamic testing and a test apparatus including the same

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a continuation application of International Patent Application No. PCT/KR2021/020018, filed on Dec. 28, 2021, which claims priority to Korean patent application No. 10-2021-0163525 filed on Nov. 24, 2021, contents of both of which are incorporated herein by reference in their entireties. 
    
    
     BACKGROUND 
     Technical Field 
     The present disclosure relates to urodynamic testing. More particularly, the present disclosure relates to a pressure sensor array for urodynamic testing capable of simultaneously measuring bladder pressure, prostate pressure, and urethral pressure, and to a test apparatus including the pressure sensor array for urodynamic testing. 
     Description of Related Technology 
     Urinary dysfunction is a symptom observed in patients with various micturition disorders such as urinary incontinence, prostatic hyperplasia, prostate pressure, cystitis, and bladder pressure. In diagnosing urinary dysfunction, a questionnaire, physical examination, radiographic examination, endoscopy, and urodynamic testing (or referred to as urodynamic study) are selectively performed. 
     The urodynamic testing provides important information for diagnosing various urinary dysfunctions, such as dysuria, urinary incontinence, and neurogenic bladder, and determining the treatment policy. The urodynamic testing is an important test that helps a more accurate diagnosis of dysuria disease. The urodynamic testing has an advantage of objectively identifying the physiological functions and conditions of the lower urinary tract, which cannot be known through a questionnaire, physical examination, radiographic examination, and endoscopy, and is therefore a necessary test for patients with urinary incontinence or prostatic hyperplasia. 
     The urodynamic testing consists of three major tests: uroflowmetry, bladder pressure measurement, and sphincter function test. 
     The uroflowmetry is a test to determine whether there is a decrease in the detrusor contraction or obstruction of the bladder outlet in a patient who complains of difficulty urinating. The bladder pressure measurement examines the bladder function while recording pressure changes that occur during bladder filling and urination. The sphincter function test is performed through electromyography, urethral pressure measurement, or urine leakage pressure measurement to determine the function of the sphincter. 
     SUMMARY 
     An object of the present disclosure is to provide a pressure sensor array capable of performing urodynamic testing conveniently and quickly and a test apparatus including the pressure sensor array. 
     Another object of the present disclosure is to provide a pressure sensor array for urodynamic testing capable of simultaneously measuring bladder pressure, prostate pressure, and urethral pressure, and a test apparatus including the same. 
     In order to accomplish the above objects, the present disclosure provides a pressure sensor array for urodynamic testing installed in a catheter, the pressure sensor array including a base substrate having flexibility; a bladder pressure sensor formed on a portion of the base substrate to be positioned in bladder and measuring bladder pressure; a prostate pressure sensor formed on a portion of the base substrate to be positioned in prostate and measuring prostate pressure; and a urethral pressure sensor formed on a portion of the base substrate to be positioned in urethra and measuring urethral pressure. 
     The bladder pressure sensor, the prostate pressure sensor, and the urethral pressure-sensor are sequentially formed on the base substrate. The bladder pressure sensor is an atmospheric pressure sensor for measuring absolute pressure in the bladder. 
     The prostate pressure sensor and the urethral pressure sensor are strain gauges for measuring pressure at which the prostate and urethra are tightened. 
     The bladder pressure sensor may be formed on an upper surface of the base substrate. 
     The prostate pressure sensor and the urethral pressure sensor may be formed on a lower surface of the base substrate. 
     The pressure sensor array for urodynamic testing according to the present disclosure may further include readout elements formed on an upper surface of the base substrate and respectively reading out pressures measured by the bladder pressure sensor, the prostate pressure sensor, and the urethral pressure sensor. 
     In addition, the present disclosure provides a urodynamic test apparatus that includes a catheter inserted into bladder through urethra and prostate; and a pressure sensor array installed in the catheter and measuring bladder pressure, prostate pressure, and urethral pressure. 
     The bladder pressure sensor protrudes out of a tip of the catheter. 
     The prostate pressure sensor and the urethral pressure sensor are located inside the catheter. 
     The pressure sensor array is installed in the catheter such that the lower surface of the base substrate is in close contact with an inner surface of the catheter. 
     According to the present embodiment, it is possible to simultaneously measure the bladder pressure, the prostate pressure, and the urethral pressure through the pressure sensor array provided in the catheter. 
     Because of having a structure that the pressure sensor array is inserted into the catheter, the urodynamic test apparatus according to the present embodiment is capable of simultaneously measuring the bladder pressure, the prostate pressure, and the urethral pressure while minimizing a structural change thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is an exploded perspective view showing a test apparatus including a pressure sensor array for urodynamic testing according to an embodiment of the present disclosure. 
         FIG.  2    is a combined perspective view showing the test apparatus of  FIG.  1   . 
         FIG.  3    is a plan view showing a lower surface of the pressure sensor array of  FIG.  1   . 
         FIG.  4    is a plan view showing an upper surface of the pressure sensor array of  FIG.  1   . 
         FIG.  5    is a cross-sectional view taken along line  5 - 5  of  FIG.  3   . 
         FIG.  6    is a cross-sectional view showing the bladder pressure sensor positioned outside a tip of the catheter. 
         FIG.  7    is a cross-sectional view showing the prostate pressure sensor positioned inside the catheter. 
         FIG.  8    is a cross-sectional view showing readout elements positioned inside the catheter. 
     
    
    
     DETAILED DESCRIPTION 
     Recently, a test method that simultaneously performs the uroflowmetry and the bladder pressure measurement has been implemented, and the electromyography and the imaging tests are sometimes performed selectively. 
     The urodynamic testing is very complex, and the process and technology are also complicated. So, a number of test modules are installed in and connected to the test equipment for the urodynamic testing, resulting in bulky and heavy. 
     Therefore, the urodynamic test equipment is almost impossible to move, so that the patient is to be tested next to it. In general, the hospital separately provides the urodynamic laboratory equipped with the urodynamic test equipment, and the patient is subjected to the urodynamic testing in the laboratory. That is, the patient mounts the test sensor module in a state where the test site is exposed next to the urodynamic test equipment in the laboratory, and receives the urodynamic testing. 
     In the following description, only parts necessary to understand embodiments of the present disclosure will be described, and other parts will not be described to avoid obscuring the subject matter of the present disclosure. 
     Terms used herein should not be construed as being limited to their usual or dictionary meanings. In view of the fact that the inventor can appropriately define the meanings of terms in order to describe his/her own disclosure in the best way, the terms should be interpreted as meanings consistent with the technical idea of the present disclosure. In addition, the following description and corresponding drawings merely relate to specific embodiments of the present disclosure and do not represent all the subject matter of the present disclosure. Therefore, it will be understood that there are various equivalents and modifications of the disclosed embodiments at the time of the present application. 
     Now, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. 
       FIG.  1    is an exploded perspective view showing a test apparatus including a pressure sensor array for urodynamic testing according to an embodiment of the present disclosure. 
       FIG.  2    is a combined perspective view showing the test apparatus of  FIG.  1   . 
     Referring to  FIGS.  1  and  2   , the urodynamic test apparatus  100  according to an embodiment is a test apparatus capable of measuring bladder pressure, prostate pressure, and urethral pressure which are required for urodynamic testing. The urodynamic test apparatus  100  according to this embodiment includes a catheter  10  and a pressure sensor array  60 . The catheter  10  is inserted into the bladder through the urethra and the prostate. The pressure sensor array  60  is installed in the catheter  10  and measures bladder pressure, prostate pressure, and urethral pressure. The pressure sensor array  60  includes a base substrate  20  having flexibility and also includes a bladder pressure sensor  30 , a prostate pressure sensor  40 , and a urethral pressure sensor  50 , which are formed on the base substrate  20 . The bladder pressure sensor  30  is formed on a portion of the base substrate  20  to be positioned in the bladder, and measures the bladder pressure. The prostate pressure sensor  40  is formed on a portion of the base substrate  20  to be positioned in the prostate, and measures the prostate pressure. The urethral pressure sensor  50  is formed on a portion of the base substrate  20  to be positioned in the urethra, and measures the urethral pressure. Because the pressure sensor array  60  is based on the base substrate  20  having flexibility, it can be installed by being inserted into the catheter  10  in a rolled form. The base substrate  20  has a shape of a narrow width and a long length. 
     The bladder pressure sensor  30  installed at a front portion of the pressure sensor array  60  protrudes out of the tip of the catheter  10  to measure the bladder pressure. The prostate pressure sensor  40  and the urethral pressure sensor  50  are located inside the catheter  10 . The prostate pressure sensor  40  and the urethral pressure sensor  50  measure, in the prostate and urethra, the pressure applied to the catheter  10  by urine discharged through the prostate and urethra from the bladder, thereby measuring the prostate pressure and the urethral pressure. 
     Hereinafter, the pressure sensor array  60  according to this embodiment will be described in more detail with reference to  FIGS.  3  to  8   .  FIG.  3    is a plan view showing a lower surface of the pressure sensor array  60  of  FIG.  1   .  FIG.  4    is a plan view showing an upper surface of the pressure sensor array  60  of  FIG.  1   .  FIG.  5    is a cross-sectional view taken along line  5 - 5  of  FIG.  3   .  FIG.  6    is a cross-sectional view showing the bladder pressure sensor  30  positioned outside a tip of the catheter  10 .  FIG.  7    is a cross-sectional view showing the prostate pressure sensor  40  positioned inside the catheter  10 .  FIG.  8    is a cross-sectional view showing readout elements  31 ,  41 , and  51  positioned inside the catheter. 
     The pressure sensor array  60  according to this embodiment includes the base substrate  20 , the bladder pressure sensor  30 , the prostate pressure sensor  40 , and the urethral pressure sensor  50 . 
     The base substrate  20  is a printed circuit board having flexibility and capable of transmitting pressure values measured by the bladder pressure sensor  30 , the prostate pressure sensor  40 , and the urethral pressure sensor  50  to an external controller through a circuit wiring  25 . 
     The base substrate  20  may be formed of a plastic material having flexibility. The base substrate  20  has a lower surface  21  and an upper surface  23 . 
     On the base substrate  20 , the bladder pressure sensor  30 , the prostate pressure sensor  40 , and the urethral pressure sensor  50  are sequentially formed. In particular, the prostate pressure sensor  40  and the urethral pressure sensor  50  may be formed on the lower surface  21  of the base substrate  20 , and the bladder pressure sensor  30  may be formed on the upper surface  23  of the base substrate  20 . 
     The bladder pressure sensor  30  is an atmospheric pressure sensor that measures absolute pressure in the bladder. For example, the atmospheric pressure sensor may be a parylene-coated MEMS-based absolute pressure sensor. 
     The prostate pressure sensor  40  and the urethral pressure sensor  50  are strain gauges for measuring the pressure at which the prostate and urethra are tightened. The portions of the base substrate  20  on which the prostate pressure sensor  40  and the urethral pressure sensor  50  are formed may have a larger area than the other portions. 
     In addition, the pressure sensor array  60  according to this embodiment may further include readout elements  31 ,  41 , and  51  (readout integrated circuits; ROICs). The readout elements  31 ,  41 , and  51  are formed on the upper surface  23  of the base substrate  20  and respectively read out the pressures measured by the bladder pressure sensor  30 , the prostate pressure sensor  40 , and the urethral pressure sensor  50 . In an example of this embodiment, the readout elements  31 ,  41 , and  51  are connected to the bladder pressure sensor  30 , the prostate pressure sensor  40 , and the urethral pressure sensor  50 , respectively. 
     The readout elements  31 ,  41 , and  51  include a first readout element  31  connected to the bladder pressure sensor  30 , a second readout element  41  connected to the prostate pressure sensor  40 , and a third readout element  51  connected to the urethral pressure sensor  50 . 
     When one of the bladder pressure sensor  30 , the prostate pressure sensor  40 , and the urethral pressure sensor  50  and a corresponding one of the first to third readout sensors are formed on different surfaces of the base substrate  20 , they are electrically connected to each other through a via  27  passing through the base substrate  20 . That is, because the prostate pressure sensor  40  and the urethral pressure sensor  50  are formed on the lower surface  21  of the base substrate  20 , and the second and third readout elements  41  and  51  are formed on the upper surface  23  of the base substrate  20 , the prostate pressure sensor  40  and the urethral pressure sensor  50  are electrically connected to the second and third readout elements  41  and  51  through the vias  27 , respectively. 
     Because the bladder pressure sensor  30  and the first readout element  31  are formed on the same surface, the bladder pressure sensor  30  and the first readout element  31  may be electrically connected to each other through the circuit wiring  25 . 
     The pressure sensor array  60  according to this embodiment may be installed in the catheter  10 , as follows. 
     The pressure sensor array  60  is installed in the catheter  10  such that the lower surface  21  of the base substrate  20  is in close contact with the inner surface of the catheter  10 . The bladder pressure sensor  30  is installed in the catheter  10  to protrude out of the tip of the catheter  10 . An open portion of the tip of the catheter  10  from which the bladder pressure sensor  30  protrudes is sealed with a stopper or a sealing material. 
     In addition, the prostate pressure sensor  40  and the urethral pressure sensor  50  are positioned inside the catheter  10 . At this time, the prostate pressure sensor  40  and the urethral pressure sensor  50  are installed in close contact with the inner surface of the catheter  10 . The prostate pressure sensor  40  and the urethral pressure sensor  50  being in close contact with the inner surface of the catheter  10  measure, in the prostate and urethra, the pressure applied to the catheter  10  by urine discharged through the prostate and urethra from the bladder, thereby measuring the prostate pressure and the urethral pressure. 
     As described above, according to the present embodiment, it is possible to simultaneously measure the bladder pressure, the prostate pressure, and the urethral pressure through the pressure sensor array  60  provided in the catheter  10 . 
     Because of having a structure that the pressure sensor array  60  is inserted into the catheter, the urodynamic test apparatus  100  according to the present embodiment is capable of simultaneously measuring the bladder pressure, the prostate pressure, and the urethral pressure while minimizing a structural change thereof. 
     While the present disclosure has been particularly shown and described with reference to an exemplary embodiment thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the present disclosure as defined by the appended claims.