System and method for automated dosage calculation and patient treatment life cycle

• US 10,573,409 B2
• Filed: 05/06/2019
• Issued: 02/25/2020
• Est. Priority Date: 07/13/2011
• Status: Active Grant

• Current Assignee: The Sottopelle Group LLC
• Original Assignee: The Sottopelle Group LLP
• Inventors: Tutera, Gino
• Primary Examiner(s): Burgess, Joseph D
• Application Number:
  US16/404,713
• Publication Number:
  US 20190333617A1
• Time in Patent Office: 295 Days
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

A system and method for automatically calculating an accurate recommended dosage for hormone replacement therapy and automating the life cycle of a patient'"'"'s treatment over time. The system and method can automatically acquire relevant patient parameters and apply a consistent formulaic approach to help reduce incorrect dosage determinations. A pellet insertion size may be determined and documented based on a calculated dosage, and an insertion side and lot numbers may be tracked and managed. In addition, corresponding revenues may be tracked and profitability may be reported for hormone replacement therapy practices.

Claims

1. A system for determining a dosage of a hormone to be administered to a patient, the system comprising:

an input device;

a display screen; and

a processor configured to;

receive from the input device an input signal of a user indicating an input directed to a patient sex and a patient status;

determine the patient status as at least one of a new patient, a returning patient and a booster patient;

determine the patient sex as male or female based on the input;

determine an effective estradiol dosage and an effective testosterone dosage using a dosage calculation method selected based on the patient status, automated female input parameters, and female tracking parameters by applying a pellet allocation algorithm to determine an estradiol pellet size insertion corresponding to the effective estradiol dosage and a testosterone pellet size insertion corresponding to the effective testosterone dosage when the patient sex is female, wherein a quantity of the estradiol pellet size insertion and a quantity of the testosterone pellet size insertion are minimized;

determine an effective testosterone dosage using a dosage calculation method selected based on the patient status, automated male input parameters, and male tracking parameters by applying a pellet allocation algorithm to determine a testosterone pellet size insertion corresponding to the effective testosterone dosage when the patient sex is male, wherein a quantity of the testosterone pellet size insertion is minimized;

display, on the display screen, one or more of the determined effective dosages; and

a pellet comprising at least one of the determined effective dosages inserted into the patient.

2. The system according to claim 1, wherein the automated female input parameters and the automated male input parameters comprise at least one of a physical activity level, a quantity of patient visits, patient age, patient height, weight, race, number of pregnancies, number of live births, number of abortions, history of renal disease, active liver disease, hysterectomy, history of cervical cancer, history of ovarian cancer, history of fibrocystic breast disease, history of breast cancer, current follical stimulating hormone (FSH) level, current testosterone level, current estradiol level, current non-pellet estradiol dose, current non-pellet testosterone dose, history of acne, history of facial hair, history of hair loss, history of prostate cancer, history of polycystic ovary syndrome (PCOS), history of hysterectomy, history of heavy menses, and history of metabolic syndrome.

3. The system according to claim 1, wherein the dosage calculation method includes tracking at least one of a pellet insertion location, a pellet insertion side, a pellet dose, a pellet lot number, an insertion note, a previous testosterone dose, and a previous estradiol dose.

4. The system according to claim 1, wherein the processor is further configured to:

receive a female non-pellet testosterone usage, an input indicating whether the patient is pre-menopausal, an estradiol level, and an input indicating whether the patient has migraines;

determine an estradiol dosage=0 when an input indicating that the patient is pre-menopausal, an estradiol level greater than 10 milligrams, and an input indicating that the patient has migraines is received; and

determine a testosterone dosage=0 when the computerized device receives a female non-pellet testosterone usage that is greater than zero.

5. The system according to claim 3, wherein tracking the pellet insertion location and the pellet insertion side is based on historical insertion information including at least one of a hip location, an abdominal location, a left side, and a right side.

6. The system according to claim 1, wherein the processor is further configured to apply the pellet allocation algorithm by:

providing a plurality of pellet sizes ordered from largest to smallest;

subtracting a largest of the plurality of pellet sizes from the effective dosage;

assigning the largest of the plurality of pellet sizes as the estradiol pellet size insertion or the testosterone pellet size insertion when a result of the subtraction is greater than zero;

when the result of the subtraction is less than or equal to zero, subsequently subtracting a next smallest one of the plurality of pellet sizes from the effective dosage and repeating this calculation using each successively smaller pellet size until the result is greater than zero;

calculating an absolute value of the result of the subtraction that is less than zero that corresponds with a smallest pellet size resulting in a negative number and of the result of the subtraction that is greater than zero; and

assigning one of the plurality of pellet sizes as the estradiol pellet size insertion or the testosterone pellet size insertion corresponding to the result having a lesser absolute value.

7. The system according to claim 6, wherein:

the display is further configured to display an estradiol pellet size insertion corresponding to the effective estradiol dosage and a testosterone pellet size insertion corresponding to the effective testosterone dosage; and

the processor is further configured to;

receive a user indication of at least one of an increase and a decrease in at least one of the estradiol pellet size insertion and the testosterone pellet size insertion; and

calculate an updated effective estradiol dosage and an updated effective testosterone dosage based on the received user indication.

8. A computer-implemented method of providing a dosage and a patient treatment life-cycle comprising:

receiving by a computerized device, an input signal from a user indicating an input directed to a patient sex and a patient status;

determining, by the computerized device, the patient status to be at least one of a new patient, a returning patient and a booster patient;

determining by the computerized device, an effective estradiol dosage and an effective testosterone dosage using a dosage calculation method selected based on the patient status, automated female input parameters, and female tracking parameters by applying a pellet allocation algorithm to determine an estradiol pellet size insertion corresponding to the effective estradiol dosage and a testosterone pellet size insertion corresponding to the effective testosterone dosage when the patient sex is female, wherein a quantity of the estradiol pellet size insertion and a quantity of the testosterone pellet size insertion are minimized;

determining by the computerized device, an effective testosterone dosage using a dosage calculation method selected based on the patient status, automated male input parameters, and male tracking parameters by applying a pellet allocation algorithm to determine a testosterone pellet size insertion corresponding to the effective testosterone dosage when the patient sex is male, wherein a quantity of the testosterone pellet size insertion is minimized;

displaying, on a display screen of the computerized device, one or more of the determined effective dosages; and

administering a pellet comprising at least one of the determined effective dosages to the patient.

9. The method according to claim 8, wherein the automated female input parameters and the automated male input parameters comprise at least one of a physical activity level, a quantity of patient visits, patient age, patient height, weight, race, number of pregnancies, number of live births, number of abortions, history of renal disease, active liver disease, hysterectomy, history of cervical cancer, history of ovarian cancer, history of fibrocystic breast disease, history of breast cancer, current follical stimulating hormone (FSH) level, current testosterone level, current estradiol level, current non-pellet estradiol dose, current non-pellet testosterone dose, history of acne, history of facial hair, history of hair loss, history of prostate cancer, history of polycystic ovary syndrome (PCOS), history of hysterectomy, history of heavy menses, and history of metabolic syndrome.

10. The method according to claim 8, wherein the dosage method for a female booster and return patient further comprises:

receiving, by the computerized device, a female non-pellet testosterone usage, an input indicating whether the patient is pre-menopausal, an estradiol level, and an input indicating whether the patient has migraines;

determining, by the computerized device, an estradiol dosage=0 when an input indicating that the patient is pre-menopausal, an estradiol level greater than 10 milligrams, and an input indicating that the patient has migraines is received; and

determining, by the computerized device, a testosterone dosage=0 when the computerized device receives a female non-pellet testosterone usage that is greater than zero.

11. The method according to claim 8, wherein determining the effective dosages is based on input parameters comprising at least one of a physical activity level, a quantity of patient visits, patient age, patient height, weight, race, number of pregnancies, number of live births, number of abortions, history of renal disease, active liver disease, hysterectomy, history of cervical cancer, history of ovarian cancer, history of fibrocystic breast disease, history of breast cancer, current follical stimulating hormone (FSH) level, current testosterone level, current estradiol level, current non-pellet estradiol dose, current non-pellet testosterone dose, history of acne, history of facial hair, history of hair loss, history of prostate cancer, history of polycystic ovary syndrome (PCOS), history of hysterectomy, history of heavy menses, and history of metabolic syndrome.

12. The method according to claim 8, wherein using the dosage calculation method selected based on at least one of the female tracking parameters and the male tracking parameters comprises tracking at least one of a pellet insertion location, a pellet insertion side, a pellet dose, a pellet lot number, an insertion note, a previous testosterone dose, and a previous estradiol dose.

13. The method according to claim 12, wherein tracking the pellet insertion location and the pellet insertion side is based on historical insertion information including at least one of a hip location, an abdominal location, a left side, and a right side.

14. The method according to claim 8, wherein applying the pellet allocation algorithm comprises:

providing a plurality of pellet sizes ordered from largest to smallest;

subtracting, by the computerized device, a largest of the plurality of pellet sizes from the effective dosage;

assigning, by the computerized device, the largest of the plurality of pellet sizes as the estradiol pellet size insertion or the testosterone pellet size insertion when a result of the subtraction is greater than zero;

when the result of the subtraction is less than or equal to zero, subsequently subtracting, by the computerized device, a next smallest one of the plurality of pellet sizes from the effective dosage and repeating this calculation using each successively smaller pellet size until the result is greater than zero;

calculating, by the computerized device, an absolute value of the result of the subtraction that is less than zero that corresponds with a smallest pellet size resulting in a negative number and of the result of the subtraction that is greater than zero; and

assigning, by the computerized device, one of the plurality of pellet sizes as the estradiol pellet size insertion or the testosterone pellet size insertion corresponding to the result having a lesser absolute value.

15. The method according to claim 14, further comprising:

displaying, on the display of the computerized device, an estradiol pellet size insertion corresponding to the effective estradiol dosage and a testosterone pellet size insertion corresponding to the effective testosterone dosage;

receiving, by the computerized device, a user indication of at least one of an increase and a decrease in at least one of the estradiol pellet size insertion and the testosterone pellet size insertion; and

calculating, by the computerized device, an updated effective estradiol dosage and an updated effective testosterone dosage based on the received user indication.