# US 12,758,706 B2 · Occlusion detection system and method

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- Number: US 12,758,706 B2
- Document ID: US12758706B2
- Status: Granted
- Kind: B2
- Application number: 18/913,123
- Filed: 2024-10-11
- Published: 2025-01-30
- Granted: 2026-10-13
- Earliest claimed: 2008-10-10
- Assignees: DEKA Products Limited Partnership
- Applicants: DEKA Products Limited Partnership
- Inventors: Marc A. Mandro; Robert J. Bryant
- Web page: https://patentgrep.com/patent/US12758706B2

## CPC

- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/14566: {with a replaceable reservoir for receiving a piston rod of the pump}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 2005/14573: {with a replaceable reservoir for quick connection/disconnection with a driving system}
- A61M 2005/16863
- A61M 2205/332: Force measuring means
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/8206: battery-operated
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method, computer program product, and infusion pump assembly for determining a first rate-of-change force reading that corresponds to the delivery of a first dose of an infusible fluid via an infusion pump assembly. At least a second rate-of-change force reading is determined that corresponds to the delivery of at least a second dose of the infusible fluid via the infusion pump assembly. An average rate-of-change force reading is determined based, at least in part upon the first rate-of-change force reading and the at least a second rate-of-change force reading.

## Claims

### Claim 1

A method for an infusion pump assembly, wherein the infusion pump assembly comprises a reservoir assembly and a pump assembly, the pump assembly including a plunger assembly and a motor assembly, the method comprising:
storing an infusible fluid in the reservoir assembly;
displacing the plunger assembly that is operably connected to the reservoir assembly in response to signals received by the motor assembly from a processing logic;
dispensing the infusible fluid from the reservoir assembly through a cannula assembly
monitoring one or more displaceable mechanical components included within the infusion pump assembly to determine if the one or more displaceable mechanical components were displaced an expected displacement in response to delivery of one or more of the first dose of the infusible fluid and the second dose of the infusible fluid; and
if the one or more displaceable mechanical components were not displaced the expected displacement in response to delivery of one or more of the first dose of the infusible fluid and the second dose of the infusible fluid, initiating an alarm sequence on the infusion pump assembly.

### Claim 2 (depends on 1)

The method of claim 1, wherein the infusion pump assembly includes a processing logic which includes at least one microprocessor configured to interact with a memory system, the method further comprising:
storing instruction sets and subroutines of an occlusion detection process on the memory system; and
accessing and executing said instruction sets and subroutines via the connection between the processing logic and the at least one microprocessor.

### Claim 3 (depends on 1)

The method of claim 1, wherein the infusion pump assembly includes a battery assembly configured to power the infusion pump assembly, the method further comprising:
comparing an actual voltage level of the battery assembly to a minimum voltage requirement to determine if the actual voltage level meets the minimum voltage requirement;
if the actual voltage level does not meet the minimum voltage requirement, initiating an alarm sequence on the infusion pump assembly, wherein the alarm sequence includes any combination of visual-based, audible-based and/or vibration-based alarms.

### Claim 4 (depends on 1)

The method of claim 1, further comprising:
determining a first initial reading prior to dispensing a first dose of an infusible fluid;
dispensing the first dose of the infusible fluid;
monitoring a volume of the infusible fluid dispensed in the first dose;
determining a second initial reading prior to dispensing a second dose of the infusible fluid;
setting a first final reading value as being equal to the second initial reading;
dispensing the second dose of the infusible fluid;
monitoring a volume of the infusible fluid dispensed in the second dose;
determining a second final reading subsequent to dispensing the second dose of the infusible fluid;
determining a first rate-of-change reading that corresponds to the delivery of the first dose of the infusible fluid via an infusion pump assembly by subtracting the first initial reading from the first final reading value;
determining at least a second rate-of-change reading that corresponds to the delivery of the second dose of the infusible fluid via the infusion pump assembly by subtracting the second initial reading from the second final reading;
normalizing the first rate-of-change reading and the second rate-of-change reading to be indicative of the rates-of-change sensed for an equivalent quantity of infusible fluid; and
determining an average rate-of-change reading based, at least in part upon the normalized first rate-of-change reading and the normalized at least a second rate-of-change reading.

### Claim 5 (depends on 1)

The method of claim 1, further comprising:
comparing the average rate-of-change reading to a threshold rate-of-change reading to determine if the average rate-of-change reading exceeds the threshold rate-of-change reading; and
if the average rate-of-change reading exceeds the threshold rate-of-change reading, initiating an alarm sequence on the infusion pump assembly.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
comparing one or more of the first initial reading and the first final reading to a threshold reading to determine if one or more of the first initial reading and the first final reading exceeds the threshold reading; and
if one or more of the first initial reading and the first final reading exceeds the threshold reading, initiating an alarm sequence on the infusion pump assembly.

### Claim 7 (depends on 1)

The method of claim 1, wherein the infusion pump assembly includes a battery assembly configured to power the infusion pump assembly, the method further comprising:
comparing an actual voltage level of the battery assembly to a minimum voltage requirement to determine if the actual voltage level meets the minimum voltage requirement; and
if the actual voltage level does not meet the minimum voltage requirement, initiating an alarm sequence on the infusion pump assembly.

### Claim 8

A computer program product residing on a non-transitory computer readable medium in an infusion pump assembly having a plurality of instructions stored thereon which, when executed by a processing logic, cause the processing logic to perform operations comprising:
storing an infusible fluid in a reservoir assembly;
displacing a plunger assembly that is operably connected to the reservoir assembly in response to signals received by a motor assembly from the processing logic;
dispensing the infusible fluid from the reservoir assembly through a cannula assembly
determining a first initial reading prior to dispensing a first dose of an infusible fluid;
dispensing the first dose of the infusible fluid;
monitoring a volume of the infusible fluid dispensed in the first dose;
determining a second initial reading prior to dispensing a second dose of the infusible fluid;
setting a first final reading value as being equal to the second initial reading;
dispensing the second dose of the infusible fluid;
monitoring a volume of the infusible fluid dispensed in the second dose;
determining a second final reading subsequent to dispensing the second dose of the infusible fluid;
determining a first rate-of-change reading that corresponds to the delivery of the first dose of the infusible fluid via an infusion pump assembly by subtracting the first initial reading from the first final reading value;
determining at least a second rate-of-change reading that corresponds to the delivery of the second dose of the infusible fluid via the infusion pump assembly by subtracting the second initial reading from the second final reading;
normalizing the first rate-of-change reading and the second rate-of-change reading to be indicative of the rates-of-change sensed for an equivalent quantity of infusible fluid; and
determining an average rate-of-change reading based, at least in part upon the normalized first rate-of-change reading and the normalized at least a second rate-of-change reading.

### Claim 9 (depends on 8)

The computer program product of claim 8, further comprising instructions for:
comparing the average rate-of-change reading to a threshold rate-of-change reading to determine if the average rate-of-change reading exceeds the threshold rate-of-change reading; and
if the average rate-of-change reading exceeds the threshold rate-of-change reading, initiating an alarm sequence on the infusion pump assembly.

### Claim 10 (depends on 8)

The computer program product of claim 8, further comprising instructions for:
comparing one or more of the first initial reading and the first final reading to a threshold reading to determine if one or more of the first initial reading and the first final reading exceeds the threshold reading; and
if one or more of the first initial reading and the first final reading exceeds the threshold reading, initiating an alarm sequence on the infusion pump assembly.

### Claim 11 (depends on 8)

The computer program product of claim 8, wherein the infusion pump assembly includes a battery assembly configured to power the infusion pump assembly, the computer program product further comprising instructions for:
comparing an actual voltage level of the battery assembly to a minimum voltage requirement to determine if the actual voltage level meets the minimum voltage requirement; and
if the actual voltage level does not meet the minimum voltage requirement, initiating an alarm sequence on the infusion pump assembly.

### Claim 12

An infusion pump assembly configured to perform operations comprising:
storing an infusible fluid in a reservoir assembly;
displacing a plunger assembly that is operably connected to the reservoir assembly in response to signals received by a motor assembly from a processing logic;
dispensing the infusible fluid from the reservoir assembly through a cannula assembly
determining a first initial reading prior to dispensing a first dose of an infusible fluid;
dispensing the first dose of the infusible fluid;
monitoring a volume of the infusible fluid dispensed in the first dose;
determining a second initial reading prior to dispensing a second dose of the infusible fluid;
setting a first final reading value as being equal to the second initial reading;
dispensing the second dose of the infusible fluid;
monitoring a volume of the infusible fluid dispensed in the second dose;
determining a second final reading subsequent to dispensing the second dose of the infusible fluid;
determining a first rate-of-change reading that corresponds to the delivery of the first dose of the infusible fluid via an infusion pump assembly by subtracting the first initial reading from the first final reading value;
determining at least a second rate-of-change reading that corresponds to the delivery of the second dose of the infusible fluid via the infusion pump assembly by subtracting the second initial reading from the second final reading;
normalizing the first rate-of-change reading and the second rate-of-change reading to be indicative of the rates-of-change sensed for an equivalent quantity of infusible fluid; and
determining an average rate-of-change reading based, at least in part upon the normalized first rate-of-change reading and the normalized at least a second rate-of-change reading.

### Claim 13 (depends on 12)

The infusion pump assembly of claim 12, wherein the infusion pump assembly is further configured to perform operations comprising:
comparing the average rate-of-change reading to a threshold rate-of-change reading to determine if the average rate-of-change reading exceeds the threshold rate-of-change reading; and
if the average rate-of-change reading exceeds the threshold rate-of-change reading, initiating an alarm sequence on the infusion pump assembly.

### Claim 14 (depends on 12)

The infusion pump assembly of claim 12, wherein the infusion pump assembly is further configured to perform operations comprising:
comparing one or more of the first initial reading and the first final reading to a threshold reading to determine if one or more of the first initial reading and the first final reading exceeds the threshold reading; and
if one or more of the first initial reading and the first final reading exceeds the threshold reading, initiating an alarm sequence on the infusion pump assembly.

### Claim 15 (depends on 12)

The infusion pump assembly of claim 12, wherein the infusion pump assembly includes a battery assembly configured to power the infusion pump assembly and the infusion pump assembly is further configured to perform operations comprising:
comparing an actual voltage level of the battery assembly to a minimum voltage requirement to determine if the actual voltage level meets the minimum voltage requirement; and
if the actual voltage level does not meet the minimum voltage requirement, initiating an alarm sequence on the infusion pump assembly.