IP Library Granted Patent US 11,972,369
Granted Patent B2
US 11,972,369 · App. 18/138,526 · Granted Apr 30, 2024

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

Inventor: Gino Tutera (Scottsdale, AZ)
Assignee: The SottoPelle Group, LLC
G06Q10/00G16H10/60G16H20/10G16H10/20G16H40/20G16H50/70
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,972,369
App. No.
18/138,526
Granted
Apr 30, 2024
Kind
B2
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 (124)

1. A method of providing hormone replacement therapy, comprising:

determining, by a computerized device, a therapeutically effective amount of a pharmaceutical composition comprising at least one compound selected from the group consisting of an estradiol compound and a testosterone compound based on information about a subject having hormone replacement therapy,

wherein the therapeutically effective amount of the pharmaceutical composition is contained within a quantity of pellets that is minimized; and

subcutaneously administering, by a user, the minimized quantity of pellets containing the pharmaceutical composition to the subject having the hormone replacement therapy.

2. The method of claim 1 , wherein the estradiol compound is a bioidentical estradiol hormone.

3. The method of claim 1 , wherein the testosterone compound is a bioidentical testosterone hormone.

4. The method of claim 1 , wherein the subcutaneous administration of the quantity of minimized pellets occurs at an insertion location selected from the group consisting of:

a hip, a right hip, a left hip, an abdominal wall, an upper abdominal wall, a lower abdominal wall, a mid-abdominal wall, a buttock, an upper buttock, a lower buttock, a middle buttock, a location opposite from a previous insertion, a location relative to a previous insertion, a manually selected location, and a combination of the insertion location.

5. The method of claim 1 , wherein the hormone replacement therapy further comprises a delivery profile configured to deliver the therapeutically effective amount of the pharmaceutical composition over a time period that approximates what a human gonad dependent on heart rate and cardiac output may deliver, and

wherein the delivery profile is selected from a group consisting of:

a consistent delivery of the therapeutically effective amount of the pharmaceutical composition over about a 3 month to about a 5 month time period;

a consistent delivery of the therapeutically effective amount of the pharmaceutical composition over about a 4 month to about a 6 month time period;

a controlled released delivery of the therapeutically effective amount of the pharmaceutical composition over about a 3 month to about a 5 month time period;

a controlled release delivery of the therapeutically effective amount of the pharmaceutical composition over about a 4 month to about a 6 month time period; and

a combination of the delivery profile.

6. The method of claim 1 , wherein the subject is a female patient and determining, by the computerized device, the therapeutically effective amount of the pharmaceutical composition further comprises:

determining, by a processor, a personalized female therapeutically effective dosage of the estradiol compound by:

generating, by the processor, a subject weight to age ratio lookup value from the subject weight to the subject age;

generating, by the processor, a female estradiol age lookup value;

generating, by the processor, a female estradiol FSH lookup value;

generating, by the processor, a female estradiol problem factor;

generating, by the processor, a FSH estradiol adjustment; and

summing, by the processor, the FSH estradiol adjustment with

a multiplication of the female estradiol problem factor by

a summation of:

 the subject weight to age ratio lookup value;

 the female estradiol age lookup value; and

 the female estradiol FSH lookup value; and

determining, by the processor, a personalized female therapeutically effective dosage of the testosterone compound by:

generating, by the processor, a female testosterone weight lookup value;

generating, by the processor, a female testosterone age lookup value;

generating, by the processor a female testosterone testosterone lookup value; and

multiplying, by the processor, the female testosterone age lookup value by

a summation of:

the female testosterone weight lookup value; and

the female testosterone testosterone value.

7. The method of claim 1 , wherein the subject is a female return patient and determining, by the computerized device, the therapeutically effective amount of the pharmaceutical composition further comprises:

determining, by a processor, a personalized female therapeutically effective dosage of estradiol by:

generating, by the processor, a subject weight to age ratio lookup value from the subject weight to the subject age;

generating, by the processor, a female estradiol age lookup value;

generating, by the processor, a female estradiol FSH lookup value;

retrieving, by the processor, a previous personalized female therapeutically effective dosage of estradiol,

wherein the previous personalized female therapeutically effective dosage of estradiol is configured as the personalized female therapeutically effective dosage of estradiol from a previous insertion; and

multiplying, by the processor, the female estradiol problem factor by

a summation of:

the subject weight to age ratio lookup value;

the female estradiol age lookup value;

the female estradiol FSH lookup value; and

the previous personalized female therapeutically effective dosage of estradiol.

8. The method of claim 7 , further comprising:

determining, by the processor, a personalized female therapeutically effective dosage of testosterone by:

generating, by the processor, a female testosterone weight lookup value;

generating, by the processor, a female testosterone age lookup value;

generating, by the processor a female testosterone testosterone lookup value; and

multiplying, by the processor, the female testosterone age lookup value by

a summation of:

the female testosterone weight lookup value; and

the female testosterone testosterone value.

9. The method of claim 7 , wherein the personalized female therapeutically effective dosage of testosterone is reduced by 12.5 mg and multiplied by a historical factor.

10. The method of claim 1 , wherein the subject is a female booster patient and the method further comprises:

retrieving, by the processor, a previous personalized female therapeutically effective dosage of estradiol,

wherein the previous personalized female therapeutically effective dosage of estradiol is configured as the personalized female therapeutically effective dosage of estradiol from a previous appointment;

retrieving, by the processor, a previous personalized female therapeutically effective dosage of testosterone,

wherein the previous personalized female therapeutically effective dosage of testosterone is configured as the personalized female therapeutically effective dosage of testosterone from a previous appointment;

dividing, by the processor, the previous personalized female therapeutically effective dosage of estradiol by a female booster estradiol adjustment factor of 2.00; and

dividing, by the processor, the previous personalized female therapeutically effective dosage of estradiol by a female booster estradiol adjustment factor of 3.00.

11. The method of claim 6 ,

wherein the female subject weight to age ratio is selected from the group consisting of:

a subject weight to age ratio lookup value of 1 mg for the subject's weight to age ratio of 0 to 1.5;

a subject weight to age ratio lookup value of 2 mg for the subject's weight to age ratio of 1.6 to 2.5;

a subject weight to age ratio lookup value of 3 mg for the subject's weight to age ratio of 2.6 to 3.9; and

a subject weight to age ratio lookup value of 2 mg for the subject's weight to age ratio greater than 4.

12. The method of claim 6 , wherein the female estradiol age lookup value is selected from a group consisting of:

a female estradiol age lookup value of 3 for the subject's age less than 40;

a female estradiol age lookup value of 5 for the subject's age between 40 and 50;

a female estradiol age lookup value of 15 for the subject's age between 51 and 60;

a female estradiol age lookup value of 12.5 for the subject's age between 61 and 68; and

a female estradiol age lookup value of 4 for the subject's age greater than 68.

13. The method of claim 6 , wherein the female estradiol FSH lookup value is selected from a group consisting of:

a female estradiol FSH lookup value of 0 for the subject's FSH less than 31;

a female estradiol FSH lookup value of 1 for the subject's FSH between 31 and 50;

a female estradiol FSH lookup value of 2 for the subject's FSH between 51 and 100; and

a female estradiol FSH lookup value of 3 for the subject's FSH greater than 100.

14. The method of claim 6 , wherein the female estradiol problem factor is selected from the group consisting of:

a history of acne female problem factor of 0.90;

a history of hair loss female problem factor of 0.88;

a hysterectomy female problem factor of 0.75;

a history of heavy menses female problem factor of 0.88;

a history of metabolic syndrome female problem factor of 0.00;

a persistent breast pain female problem factor of 0.80;

a mid-cycle bleeding female problem factor of 0.80;

a headache female problem factor of 0.75;

a fluid retention female problem factor of 0.75;

a fibrocystic breast disease female problem factor of 0.70; and

a no female problem factor of 1 for no problem adjustment.

15. The method of claim 6 , wherein the FSH estradiol adjustment is selected from the group consisting of:

a FSH adjustment of 12.5 when the subject's age between 20 and 50 and the subject's FSH greater or equal to 30; and

a FSH adjustment of 0 for no history.

16. The method of claim 6 , wherein the female testosterone weight lookup value is selected from a group consisting of:

a female testosterone weight lookup value of 75 for the subject's weight between 75 and 150;

a female testosterone weight lookup value of 87.5 for the subject's weight between 151 and 200; and

a female testosterone weight lookup value of 100 for the subject's weight greater than 200.

17. The method of claim 6 , wherein the female testosterone age lookup value is selected from a group consisting of:

a female testosterone age lookup value of 1 for the subject's age between 0 and 67; and

a female testosterone age lookup value of 0.63 for the subject's age greater than 67.

18. The method of claim 6 , wherein the female testosterone testosterone lookup value is selected from a group consisting of:

a female testosterone testosterone lookup value of 37.5 for the subject's testosterone between 0 and 20;

a female testosterone testosterone lookup value of 25 for the subject's testosterone between 21 and 100; and

a female testosterone testosterone lookup value of 0 for the subject's testosterone greater than 100.

19. The method of claim 1 , wherein the is a male subject and determining, by the computerized device, the therapeutically effective amount of the pharmaceutical composition further comprises:

determining, by a processor, a personalized male therapeutically effective dosage of the testosterone compound by:

generating, by the processor, a male testosterone age lookup value;

generating, by the processor, a male testosterone weight lookup value;

generating, by the processor, a male adjustment factor; and

multiplying, by the processor:

the male testosterone age lookup value;

the male testosterone weight lookup value; and

the male adjustment factor.

20. The method of claim 1 , wherein the subject is a male return patient and further comprises:

retrieving, by the processor, a previous personalized male therapeutically effective dosage of testosterone,

wherein the previous personalized male therapeutically effective dosage of testosterone is configured as the personalized male therapeutically effective dosage of testosterone from a previous appointment;

retrieving, by the processor, a male current testosterone dose lookup value,

wherein the male current testosterone dose lookup value represents the subject's current level of testosterone; and

subtracting, by the processor, 200.00 mg from the previous personalized male therapeutically effective dosage of testosterone if the male current testosterone dose lookup value is less than 400 mg.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2023
From: TUTERA, GINO
To: THE SOTTOPELLE GROUP, LLC
Reel/Frame 063420/0599 →
Continuity (9)
Continuation 17736042 · May 3, 2022
Continuation 16799783 · Feb 24, 2020
Continuation 16404713 · May 6, 2019
Continuation 15164175 · May 25, 2016
Continuation 14306206 · Jun 16, 2014
Continuation In Part 13721949 · Dec 20, 2012
Continuation 13548714 · Jul 13, 2012
Provisional Application 61507318 · Jul 13, 2011
Related Publication 20230259832A1 · Aug 17, 2023