Diagnosis of lower urinary tract dysregulation

• US 20040015100A1
• Filed: 03/07/2003
• Published: 01/22/2004
• Est. Priority Date: 09/13/2000
• Status: Active Grant

• Current Assignee: Richard A. Schmidt
• Original Assignee: Richard A. Schmidt
• Inventors: Schmidt, Richard A.
• Granted Patent: US 7,431,701 B2
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: Y10S 128/923 by comparison of patient data to other data

Abstract

The invention disclosed herein provides a system and method for diagnosing lower urinary system conditions by receiving urodynamic data and subjective symptomatic impressions concerning a patient. The system and method then assigns weighted point values to the urodynamic data, for example, urethal pressure profiles due to sphincter contraction conditions such as urgency (2) and stress incontinence (4), and the subjective symptomatic impressions, quantifies norms for lower urinary system function, as a whole or in part, and quantifies recognized pathologies of lower urinary system conditions as degrees of departure from the norms. The system and method then determines a lower urinary system condition diagnosis of the patient, as a function of the degrees of departure from the norms, by invoking a set of rules to compare the weighted point values assigned and the quantified norms. The invention then reports the lower urinary system condition diagnosis, treatment recommendation, or further diagnostic suggestions.

Claims

1. The method of diagnosing lower urinary system conditions of a patient, the method comprising:

receiving urodynamic data concerning the patient;

receiving subjective symptomatic impressions concerning the patient;

assigning at least one weighted point value to at least one of the urodynamic data and the subjective symptomatic impressions;

quantifying at least one norm for at least one part of lower urinary system function as at least one numeric score;

quantifying at least one recognized pathology of lower urinary system conditions as a degree of departure from the at least one norm;

determining a lower urinary system condition diagnosis of the patient, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one weighted point value assigned to the at least one numeric score quantified; and

reporting the lower urinary system condition diagnosis.

2. The method as described in claim 1 wherein the urodynamic data comprises a urethral pressure profile of the patient.

3. The method as described in claim 2 wherein the urodynamic data further comprises sphincter dynamic data of the patient of a type of at least one the following:

the internal anal sphincter, the external anal sphincter, the internal urethral sphincter, and the external urethral sphincter.

4. The method as described in claim 1 wherein the urodynamic data comprises data generated from at least one of the following diagnostic tools:

radiology, ultrasound, motor sensory evoked response activity, electromyographic recordings, magnetic resonance tomography, computed tomography, and nuclear imaging.

5. The method as described in claim 1 wherein the urodynamic data comprises:

urethra characteristics;

bladder characteristics; and

urinary system flow rates of the patient.

6. The method as described in claim 5 wherein the urethra characteristics and the bladder characteristics are measured in at least one of the qualities of tone, reflex excitability, sensation, and structural change.

7. The method as described in claim 1 wherein the step of receiving urodynamic data further comprises:

recognizing graphical urodynamic patterns; and

converting the graphical urodynamic patterns into the urodynamic data.

8. The method as described in claim 1 further comprising:

receiving a plurality of urodynamic datum and subjective symptomatic impressions concerning a plurality of patients, respectively;

assigning a plurality of weighted point values to the plurality of urodynamic datum and subjective symptomatic impressions, respectively; and

wherein the step of quantifying the at least one norm further comprises;

determining the at least one numeric score as a functional average of the plurality of weighted point values; and

determining the at least one degree of departure from the at least one norm as a functional average of the plurality of weighted point values.

9. The method as described in claim 8 further comprising:

receiving a plurality of additional diagnostic datum concerning the plurality of patients, respectively;

assigning a plurality of second weighted point values to the plurality of additional diagnostic datum, respectively; and

wherein the step of quantifying the at least one norm further comprises;

determining the at least one numeric score as a functional average of a combination of the plurality of weighted point values and the plurality of second weighted point values; and

determining the at least one degree of departure from the at least one norm as a functional average of a combination of the plurality of weighted point values and the plurality of second weighted point values.

10. The method as described in claims 1, 8, or 9 further comprising:

determining a treatment recommendation, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one weighted point value assigned to the at least one numeric score quantified; and

reporting the treatment recommendation.

11. The method as described in claim 10 wherein the step of reporting further comprises:

detailing a severity level of the urinary system condition diagnosis; and

providing a treatment ladder in step with the severity level.

12. The method as described in claims 1, 8, or 9 further comprising:

determining a recommendation for further diagnostic testing, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one weighted point value assigned to the at least one numeric score quantified; and

reporting the recommendation for further diagnostic testing.

13. The method as described in claim 1 wherein the step of reporting further comprises generating a list of references related to the lower urinary system condition diagnosis.

14. The method as described in claim 1 further comprising generating a billing statement for a fee for using the method.

15. The method as described in claim 1 wherein the step of reporting further comprises generating a summarization letter to a medical care provider for the patient.

16. The method as described in claim 1 wherein the at least one part of lower urinary system function comprises the overall lower urinary system function.

17. A system for diagnosing lower urinary system conditions of a patient, the system comprising:

at least one system input that receives urodynamic data and subjective symptomatic impressions concerning the patient;

a memory that stores

at least one numeric score quantifying at least one norm for at least one part of lower urinary system function;

at least one degree of departure from the at least one norm quantifying a recognized pathology of lower urinary system conditions; and

a set of rules for processing the urodynamic data, the subjective symptomatic impressions, the at least one numeric score, and the at least one degree of departure;

a processor that, using the set of rules, determines a urinary system condition diagnosis of the patient by;

assigning at least one weighted point value to at least one of the urodynamic data and the subjective symptomatic impressions; and

as a function of the degree of departure from the at least one norm, comparing the at least one weighted point value assigned to the at least one numeric score quantified;

a system output that reports the lower urinary system condition diagnosis.

18. The system as described in claim 17 wherein the urodynamic data comprises a urethral pressure profile of the patient.

19. The system as described in claim 18 wherein the urodynamic data further comprises sphincter dynamic data of the patient of a type of at least one the following:

the internal anal sphincter, the external anal sphincter, the internal urethral sphincter, and the external urethral sphincter.

20. The system as described in claim 17 wherein the urodynamic data comprises data generated from at least one of the following diagnostic tools:

radiology, ultrasound, motor sensory evoked response activity, electromyographic recordings, magnetic resonance tomography, computed tomography, and nuclear imaging.

21. The system as described in claim 17 wherein the urodynamic data comprises:

urethra characteristics;

bladder characteristics; and

urinary system flow rates of the patient.

22. The system as described in claim 17 wherein the urethra characteristics and the bladder characteristics are measured in at least one of the qualities of tone, reflex excitability, sensation, and structural change.

23. The system as described in claim 17 wherein the at least one system input further comprises:

a means for recognizing graphical urodynamic patterns and converting the graphical urodynamic patterns into the urodynamic data.

24. The system as described in claim 17 wherein the memory further comprises:

a database that stores a plurality of urodynamic datum and subjective symptomatic impressions concerning a plurality of patients, respectively; and

wherein the processor, using the set of rules;

assigns a plurality of weighted point values to the plurality of urodynamic datum and subjective symptomatic impressions, respectively;

determines the at least one numeric score as a functional average of the plurality of weighted point values; and

determines the at least one degree of departure from the at least one norm as a functional average of the plurality of weighted point values.

25. The system as described in claim 24 wherein the database further stores a plurality of additional diagnostic datum concerning the plurality of patients, respectively;

and

wherein the processor, using the set of rules

assigns a plurality of second weighted point values to the plurality of additional diagnostic datum, respectively;

determines the at least one numeric score as a functional average of a combination of the plurality of weighted point values and the plurality of second weighted point values; and

determines the at least one degree of departure from the at least one norm as a functional average of a combination of the plurality of weighted point values and the plurality of second weighted point values.

26. The system as described in claims 17, 24, or 25, wherein the processor, using the set of rules, further determines a treatment recommendation by, as a function of the degree of departure from the at least one norm, comparing the at least one weighted point value assigned to the at least one numeric score quantified;

and

wherein the system output further reports the treatment recommendation.

27. The system as described in claim 26 wherein the system output further reports:

a severity level of the urinary system condition diagnosis; and

a treatment ladder in step with the severity level.

28. The system as described in claims 17, 24, or 25 wherein the processor, using the set of rules, further determines a recommendation for further diagnostic testing by, as a function of the degree of departure from the at least one norm, comparing the at least one weighted point value assigned to the at least one numeric score quantified;

and

wherein the system output further reports the recommendation for further diagnostic testing.

29. The system as described in claim 17 wherein the at least one system input comprises a means for receiving a data transmission over a communications network.

30. The system as described in claim 17 wherein the system output comprises a means for transmitting a data transmission over a communications network.

31. The system as described in claim 17 wherein the system output further reports a list of references related to the lower urinary system condition diagnosis.

32. The system as described in claim 31 wherein the list of references further comprises links to access the references over a communication network.

33. The system as described in claims 29, 30, or 32 wherein the communications network comprises at least one of a local area network, a wide area network, a public network, a private network, an intranet, and the Internet.

34. The system as described in claim 17 wherein system output further reports a billing statement for a fee for using the system.

35. The system as described in claim 17 wherein system output finther reports a summarization letter to a medical care provider for the patient.

36. The system as described in claim 17 wherein the at least one part of lower urinary system function comprises the overall lower urinary system function.

37. A computer program product comprising:

a computer useable medium and computer readable code embodied on the computer useable medium for diagnosing lower urinary system conditions, the computer readable code comprising;

computer readable program code devices configured to cause a computer to accept input of urodynamic data and subjective symptomatic impressions concerning a patient over a communication network from a client machine;

computer readable program code devices configured to cause the computer to effect an assignment of at least one weighted point value to at least one of the urodynamic data and the subjective symptomatic impressions;

computer readable program code devices configured to cause the computer to effect a quantification of at least one nom for at least one part of lower urinary system function, the at least one norm being quantified as at least one numeric score;

computer readable program code devices configured to cause the computer to effect a quantification of at least one recognized pathology of lower urinary system conditions, as a degree of departure from the at least one norm; and

computer readable program code devices configured to cause the computer to effect a determination of a lower urinary system condition diagnosis of the patient, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one weighted point value to the at least one numeric score.

38. The computer program product as described in claim 37 wherein the computer readable code further comprises:

computer readable program code devices configured to cause the computer to effect a transmission of the urinary system condition diagnosis over the communication network to the client machine.

39. A computer program product comprising:

a computer useable medium and computer readable code embodied on the computer useable medium for diagnosing urinary system conditions, the computer readable code comprising;

computer readable program code devices configured to cause the computer to effect the reception of urodynamic data and subjective symptomatic impressions concerning a patient from a computer input;

computer readable program code devices configured to cause the computer to effect an assignment of at least one weighted point value to at least one of the urodynamic data and the subjective symptomatic impressions;

computer readable program code devices configured to cause the computer to effect a quantification of at least one norm for at least one part of lower urinary system function, the at least one norm being;

computer readable program code devices configured to cause the computer to effect a quantification of at least one recognized pathology of lower urinary system conditions, as a degree of departure from the at least one norm;

computer readable program code devices configured to cause the computer to effect a determination of a lower urinary system condition diagnosis of the patient, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one weighted point value to the at least one numeric score; and

computer readable program code devices configured to cause the computer to effect a reporting of the urinary system condition diagnosis to a computer output.

40. A method for determining the efficacy of a lower urinary system related treatment trial, the method comprising:

receiving first urodynamic data concerning at least one patient undergoing a treatment;

receiving first subjective symptomatic impressions concerning the at least one patient;

assigning at least one first weighted point value to the first urodynamic data and the first subjective symptomatic impressions;

quantifying at least one norm for at least one part of lower urinary system function as at least one numeric score;

quantifying at least one recognized pathology of lower urinary system conditions as a degree of departure from the at least one norm;

receiving second urodynamic data concerning at least one control patient in the treatment trial;

receiving second subjective symptomatic impressions concerning the at least one control patient;

assigning at least one second weighted point value to the second urodynamic data and the second subjective symptomatic impressions;

quantifying at least one recognized pathology of lower urinary system conditions as a second degree of departure from the at least one norm;

determining a lower urinary system condition diagnosis of the at least one patient, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one first weighted point value assigned to the at least one numeric score quantified;

determining a lower urinary system condition diagnosis of the at least one control patient, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one second weighted point value assigned to the at least one numeric score quantified;

determining the efficacy of the treatment by invoking a set of rules to compare the lower urinary system condition diagnosis of the at least one patient with the lower urinary system condition diagnosis of the at least one control patient; and

reporting the efficacy of the lower urinary system related treatment.

41. The method as described in claim 40 wherein the treatment comprises at least one of a drug product, a mechanical device, implant electrical stimulation, biofeedback, reconstructive surgery, a drug delivery system, a bulking agent, and an insertable device.

42. The method as described in claim 40 wherein the treatment trial is limited to patients with a specific pathological condition.

43. A method for determining the efficacy of a treatment for a lower urinary system condition of a patient, the method comprising:

receiving urodynamic data concerning the patient undergoing the treatment;

receiving subjective symptomatic impressions concerning the patient undergoing the treatment;

assigning at least one weighted point value to at least one of the urodynamic data and the subjective symptomatic impressions;

quantifying at least one norm for at least one part of lower urinary system function as at least one numeric score;

quantifying at least one recognized pathology of lower urinary system conditions, as a degree of departure from the at least one norm;

determining a level of improvement of the patient, and thereby the efficacy of the treatment, as a function of the degree of departure from the at least one norm, by invoking a set of rules to compare the at least one weighted point value to the at least one numeric score; and

reporting the efficacy of the treatment.

44. The method as described in claim 43 wherein the step of determining the level of improvement of the patient further comprises comparing the at least one weighted point value assigned to a previous at least one weighted point value assigned before the patient underwent the treatment.

45. The method as described in claim 43 wherein the step of determining the level of improvement of the patient further comprises comparing the at least one weighted point value assigned to a previous at least one weighted point value assigned at an earlier stage of the treatment.

46. The method as described in claim 43 wherein the step of quantifying the at least one norm is based upon the norms of patients with the specific pathological condition.

47. A communicative grading system for lower urinary system conditions classified in terms of urethra characteristics and bladder characteristics,

wherein the urethra characteristics and the bladder characteristics are measured in qualities including at least one of tone, reflex excitability, and sensation;

wherein the qualities are measured in at least one level; and

wherein the at least one level is determined as a function of;

a first plurality of urodynamic dat and subjective symptomatic impressions, wherein at least one member of the first plurality is assigned at least one value of a second plurality of weighted point values according to a set of rules;

wherein at least one norm for at least one part of lower urinary system function is determined as a first functional average of the second plurality of weighted point values as at least one numeric score; and

wherein at least one recognized pathology of lower urinary system conditions is quantified as at least one degree of departure from the at least one norm, the at least one degree of departure being determined as a second functional average of the plurality of weighted point values; and

wherein the at least one level is the difference between the at least one degree of departure and the at least one numeric score.