IP Library › Granted Patent US 12,521,484
Granted Patent B2
US 12,521,484 · App. 18/909,211 · Granted Jan 13, 2026

Irrigation system and methods of use

Inventors: Robert C. Hutton (Dallas, TX); Brian C. de Beaubien (Dallas, TX); Matthew Gill (Dallas, TX); Douglas Lorang (Dallas, TX); James McCrea (Dallas, TX); Jude Paganelli (Dallas, TX); Andrew Sauter (Dallas, TX); Michael Wong (Dallas, TX)
Assignee: Osteal Therapeutics, Inc.
A61M5/16809A61K31/4196A61K31/7036A61K38/14A61M1/772A61M3/0202A61M2005/14208A61M2205/3334
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Quick Facts
Patent No.
US 12,521,484
App. No.
18/909,211
Granted
Jan 13, 2026
Kind
B2
Abstract

A treatment delivery system includes a fluid delivery system connected to a first fluid reservoir and a second fluid reservoir. The system directs a first fluid from the first fluid reservoir to a treatment site and directs a second fluid from the second fluid reservoir to the treatment site and a control unit to control the fluid delivery system according to a treatment process comprising a flow of the first fluid and the second fluid, the treatment process including multiple phases. A first phase includes a controlled delivery of the first fluid from the first fluid reservoir to the treatment site. A second phase of the plurality of phases includes a controlled delivery of the second fluid from the second fluid reservoir to the treatment site, the control unit automatically activating a transition from at least the first phase to the second phase.

Claims (69)

1 . A treatment delivery system for treating an infected treatment site of a patient, said system comprising:

a fluid delivery system for directing a first fluid from a first fluid source to the infected treatment site and for directing a second fluid from a second fluid source to the infected treatment site, wherein the first fluid contains a first therapeutic agent and the second fluid contains a second therapeutic agent, wherein the first therapeutic agent is different from the second therapeutic agent; and

a control unit programmed to control the fluid delivery system according to a treatment process comprising a plurality of phases, wherein

a first phase of the treatment process comprises a controlled delivery of the first fluid to the infected treatment site, maintaining the first fluid at the infected treatment site for a first period of time, and removing a first site fluid from the infected treatment site, said first site fluid comprising at least some of the first fluid,

a second phase of the treatment process comprises a controlled delivery of the second fluid to the infected treatment site, maintaining the second fluid at the infected treatment site for a second period of time, and removing a second site fluid from the infected treatment site, said second site fluid comprising at least some of the second fluid,

a third phase of the treatment process comprises repeating the second phase of the treatment process with the second fluid at least once, and

a fourth phase of the treatment process comprises repeating the first phase of the treatment process with the first fluid at least once,

wherein the treatment process of the control unit automatically activates a first transition from the first phase to the second phase, a second transition from the second phase to the third phase, and a third transition from the third phase to the fourth phase, and wherein, after an initial user activation of the treatment process before the first phase, each of said first, second, third, and fourth phases and the first, second, and third transitions are caused to proceed without further user intervention or input,

wherein the first fluid comprises tobramycin antibiotic fluid and the second fluid comprises vancomycin antibiotic fluid.

2 . The treatment delivery system of claim 1 , wherein the first period of time is different from the second period of time.

3 . The treatment delivery system of claim 1 , wherein the first period of time is longer than the second period of time.

4 . A treatment delivery system for treating an infection of a treatment site of a patient, said system comprising:

a fluid delivery system for directing a first fluid from a first fluid source to the infected treatment site and for directing a second fluid from a second fluid source to the infected treatment site, wherein the first fluid contains a first antibiotic agent for treating the infection and the second fluid contains a second antibiotic agent for treating the infection, wherein the first antibiotic agent is different from the second antibiotic agent; and

a control unit programmed to control the fluid delivery system according to a treatment process comprising a plurality of phases, wherein

a first phase of the treatment process comprises a controlled delivery of the first fluid to the infected treatment site, maintaining the first fluid at the infected treatment site for a first period of time of at least 15 minutes, and removing a first site fluid from the infected treatment site, said first site fluid comprising at least some of the first fluid,

a second phase of the treatment process comprises a controlled delivery of the second fluid to the infected treatment site, maintaining the second fluid at the infected treatment site for a second period of time of at least 15 minutes, and removing a second site fluid from the infected treatment site, said second site fluid comprising at least some of the second fluid, and

a third phase of the treatment process comprises repeating the second phase of the treatment process with the second fluid at least once,

wherein the treatment process of the control unit automatically activates a first transition from the first phase to the second phase, and a second transition from the second phase to the third phase, and wherein, after an initial user activation of the treatment process before the first phase, each of said first, second and third phases and the first and second transitions are caused to proceed without further user intervention or input.

5 . The treatment delivery system of claim 4 , wherein the first fluid source comprises a first fluid reservoir and the second fluid source comprises a second fluid reservoir, and wherein the first fluid is delivered from the first fluid reservoir to the infected treatment site and wherein the second fluid is delivered from the second fluid reservoir to the infected treatment site.

6 . The treatment delivery system of claim 4 , further comprising:

a first load cell configured to detect a combined weight comprising a first weight of the first fluid and the first fluid source and a second weight of the second fluid and the second fluid source, wherein the control unit processes the combined weight measured at a first point in time and at a second point in time later than the first point, in order to monitor a status of fluid delivery.

7 . The treatment delivery system of claim 6 , wherein the status of fluid delivery comprises at least one of a first volume of the first fluid delivered from the first fluid source and a second volume of the second fluid delivered from the second fluid source.

8 . The treatment delivery system of claim 6 , wherein the first load cell is arranged within a vertical plane of the system and is configured to be contacted horizontally by a cantilevered hanger component.

9 . The treatment delivery system of claim 8 , further comprising a waste fluid canister configured to collect the first site fluid and the second site fluid removed from the infected treatment site.

10 . The treatment delivery system of claim 9 , further comprising a second load cell configured to detect a waste weight of the waste fluid canister and any fluid within the waste fluid canister, wherein the control unit processes the waste weight to monitor a status of fluid removal.

11 . The treatment delivery system of claim 10 , wherein when the waste weight equals or exceeds a threshold, an alarm is triggered.

12 . The treatment delivery system of claim 10 , wherein the second load cell is arranged within the vertical plane of the system and is configured to be contacted horizontally by a second cantilevered hanger component.

13 . The treatment delivery system of claim 9 , further comprising:

a waste fluid canister fill sensor configured to generate a waste fluid canister fill alert indicating a fill level of the waste fluid canister being above a fill threshold during the treatment process, wherein the control unit stops removal of any of the first fluid and the second fluid from the infected treatment site in response to the waste fluid canister fill alert.

14 . The treatment delivery system of claim 6 , further comprising:

an empty fluid reservoir alarm configured to generate an alert indicating that a weight of the first fluid delivered or a weight of the second fluid delivered is below a minimum threshold corresponding to a respective phase of the plurality of phases.

15 . The treatment delivery system of claim 4 , wherein the fluid delivery system further comprises at least one pinch valve controlled by the control unit to open and close according to the treatment process.

16 . The treatment delivery system of claim 15 , wherein the at least one pinch valve of the fluid delivery system comprises a first pinch valve and a second pinch valve, wherein the first pinch valve is configured to receive a first fluid delivery line adapted to be fluidly connected to the first fluid source and the second pinch valve is configured to receive a second fluid delivery line adapted to be fluidly connected to the second fluid source.

17 . The treatment delivery system of claim 16 , wherein the first pinch valve is controlled by the control unit to be open during the first phase and is controlled by the control unit to be closed during the second phase, wherein the second pinch valve is controlled by the control unit to be closed during the first phase and is controlled by the control unit to be open during the second phase.

18 . The treatment delivery system of claim 16 , wherein the first pinch valve has a first inner dimension when in an open configuration and wherein the second pinch valve has a second inner dimension when in an open configuration, wherein the first inner dimension is different than the second inner dimension.

19 . The treatment delivery system of claim 18 , wherein the first fluid delivery line has a smaller outer dimension than the second fluid delivery line, the smaller outer dimension sized to be received within the first inner dimension of the first pinch valve.

20 . The treatment delivery system of claim 18 , wherein the second fluid delivery line has an outer dimension large enough to be unable to be received within the first inner dimension of the first pinch valve.

21 . The treatment delivery system of claim 4 , wherein the control unit comprises:

a pump configured to generate a set vacuum pressure; and

a valve configured to control a vacuum relief.

22 . The treatment delivery system of claim 21 , wherein the pump is powered off during at least the first phase.

23 . The treatment delivery system of claim 21 , wherein the pump is configured to run at an approximately constant voltage during a first phase and at an approximately constant torque during a second phase to generate the set vacuum pressure.

24 . The treatment delivery system of claim 21 , further comprising:

a leak alarm configured to generate an alert indicating a pressure leak determined in response to the control unit detecting a vacuum pressure at the infected treatment site being below a threshold.

25 . The treatment delivery system of claim 4 , further comprising:

a low battery alarm configured to generate an alert indicating a charge level of a battery of the control unit, wherein the charge level of the battery is determined in response to the control unit detecting the charge level of the battery being below a minimum charge level adequate for powering automatic transition between the plurality of phases.

26 . The treatment delivery system of claim 4 , further comprising:

an incorrect assembly alarm configured to generate an alert indicating an incorrect assembly of the treatment delivery system, wherein the incorrect assembly is determined in response to the control unit detecting a missing or incorrectly coupled component of the treatment delivery system that prevents an automatic transition between the plurality of phases.

27 . The treatment delivery system of claim 4 , further comprising:

a motion alarm configured to pause fluid delivery and generate an alert indicating an excessive motion that affects a weight sensor reading during fluid delivery.

28 . The treatment delivery system of claim 4 , further comprising a user interface configured to receive a user input comprising a selection of an operation for initiating a sequence comprising the plurality of phases.

29 . The treatment delivery system of claim 4 , wherein the delivery of the first fluid to the infected treatment site comprises directing a discrete volume of about 6 mL to about 500 mL of the first fluid from the first fluid source.

30 . The treatment delivery system of claim 4 , wherein the first antibiotic agent comprises tobramycin and the second antibiotic agent comprises vancomycin.

31 . The treatment delivery system of claim 30 , wherein the first period of time is longer from the second period of time.

32 . The treatment delivery system of claim 4 , wherein maintaining the first fluid at the infected treatment site for the first period of time comprises allowing the first fluid to soak within the infected treatment site after controlled delivery of the first fluid and before removing the first site fluid.

33 . The treatment delivery system of claim 32 , wherein the first period of time is 1 hour to 3 hours.

34 . The treatment delivery system of claim 32 , wherein removing the first site fluid from the infected treatment site comprises removing the first site fluid after allowing the first fluid to soak and before instilling more fluid to the infected treatment site.

35 . The treatment delivery system of claim 4 , wherein maintaining the second fluid at the infected treatment site for the second period of time comprises allowing the second fluid to soak within the infected treatment site after controlled delivery of the second fluid and before removing the second site fluid.

36 . The treatment delivery system of claim 35 , wherein the second period of time is 15 minutes to 45 minutes.

37 . The treatment delivery system of claim 35 , wherein removing the second site fluid from the infected treatment site comprises removing the second site fluid after allowing the second fluid to soak and before instilling more fluid to the infected treatment site.

38 . The treatment delivery system of claim 4 , wherein the controlled delivery of the second fluid to the infected treatment site comprises directing a discrete volume of the second fluid from the second fluid source that is less than a total volume of the second fluid in the second fluid source.

39 . The treatment delivery system of claim 38 , wherein the discrete volume is about 50 mL and the total volume is about 500 mL to about 1500 mL.

40 . The treatment delivery system of claim 4 , further comprising a negative pressure source, wherein the negative pressure source is inactive during the first phase while the first fluid is maintained at the infected treatment site for the first period of time and is also inactive during the second phase while the second fluid is maintained at the infected treatment site for the second period of time, and wherein the first site fluid is removed from the treatment site during the first phase via negative pressure after the control unit activates the negative pressure source, and the second site fluid is removed from the treatment site during the second phase via negative pressure after the control unit again activates the negative pressure source.

41 . The treatment delivery system of claim 4 , wherein a flow rate of the first fluid increases from zero to be within a set flow rate range during the controlled delivery of the first fluid to the treatment site so that a first fluid volume within the treatment site increases, and

wherein the flow rate of the first fluid decreases back to zero during maintaining the first fluid at the infected treatment site so that the first fluid volume within the treatment site remains constant, and

wherein a flow rate of the first site fluid increases from zero to be within a set flow rate range during removing the first site fluid from the infected treatment site so that the first fluid volume within the treatment site decreases.

42 . The treatment delivery system of claim 4 , wherein a flow rate of the second fluid increases from zero to be within a set flow rate range during the controlled delivery of the second fluid to the treatment site so that a second fluid volume within the treatment site increases, and

wherein the flow rate of the second fluid decreases back to zero during maintaining the second fluid at the infected treatment site so that the second fluid volume within the treatment site remains constant, and

wherein a flow rate of the second site fluid increases from zero to be within a set flow rate range during removing the second site fluid from the infected treatment site so that the second fluid volume within the treatment site decreases.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2025
From: HUTTON, ROBERT C.; DE BEAUBIEN, BRIAN; LORANG, DOUGLAS; MCCREA, JAMES; PAGANELLI, JUDE; GILL, MATTHEW; WONG, MICHAEL; SAUTER, ANDREW
To: OSTEAL THERAPEUTICS, INC.
Reel/Frame 071420/0763 →
Continuity (7)
Continuation 18854445
Provisional Application 63613533 · Dec 21, 2023
Provisional Application 63596130 · Nov 3, 2023
Provisional Application 63519923 · Aug 16, 2023
Provisional Application 63493577 · Mar 31, 2023
Provisional Application 63486186 · Feb 21, 2023
Related Publication 20250025629A1 · Jan 23, 2025
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