System and methods for pre-injection pressure prediction in injection procedures

Patent metadata

Field	Value
Publication number	US-2017258982-A1
Application number	US-201615066130-A
Country	US
Kind code	A1
Filing date	Mar 10, 2016
Priority date	Mar 10, 2016
Publication date	Sep 14, 2017
Grant date	—

Abstract

A method of predicting peak pressure within a fluid path, which includes a tubing set and a catheter into which at least one fluid is introduced under pressure by a pressurizing system of a fluid injection apparatus, includes (a) inputting an initial injection protocol into the fluid injection apparatus according to which the at least one fluid is intended to be introduced into the fluid path; (b) predicting an expected peak pressure level that would result in the fluid path if the initial injection protocol were to be used as intended to introduce the at least one fluid into the fluid path. The expected peak pressure level is determined before commencement of the initial injection protocol according to at least one model on the basis of a flow rate of the at least one fluid, at least one catheter characteristic, and a viscosity of the at least one fluid. The at least one model is determined experimentally for a plurality of fluids of different viscosities, for a plurality of catheters of different catheter characteristics, and for at least one tubing set of like kind to the tubing set of the fluid path.

First claim

What is claimed is:

1 . A fluid injection apparatus comprising:
at least one pressurizing system; at least a first fluid path operably connectible to the at least one pressurizing system to transport fluid pressurized by the pressurizing system, the at least a first fluid path comprising a tubing set and a catheter; a control system operably associated with the at least one pressurizing system and comprising an input system, a user interface system, a processor system, and a memory system, the input system providing for input of an initial injection protocol of an injection procedure according to which at least one fluid is intended to be injected into a patient, and at least one model stored in the memory system and executable by the processor system to predict, before carrying out the initial injection protocol, if a pressure threshold value would be reached in the at least a first fluid path if the initial injection protocol were carried out, the at least one model determining if the pressure threshold value would be reached on the basis of a flow rate of the at least one fluid, at least one catheter characteristic, and a viscosity of the at least one fluid, the at least one model being determined experimentally for a plurality of fluids of different viscosities, for a plurality of catheters of different catheter characteristics, and for at least one tubing set of like kind to the tubing set of the first fluid path,
upon determining via the at least one model that the pressure threshold value would not be reached, the processor system enabling the initial injection protocol to be carried out by the fluid injection apparatus, and upon determining via the at least one model that the pressure threshold value will be reached, the processor system either (I) alerting an operator via the user interface system, whereupon the operator is enabled to choose between (a) permitting the initial injection protocol to be carried out by the fluid injection apparatus as programmed and (b) effecting a change to update the initial injection protocol for input into the at least one model or (II) automatically effecting a change to update the initial injection protocol to create an updated injection protocol so that the expected pressure level will be determined via the at least one model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be used to introduce the at least one fluid into the fluid path.

2 . The fluid injection apparatus of claim 1 wherein effecting a change to update the initial injection protocol for input into the at least one model comprises at least one of (a) changing the flow rate of the fluid, (b) changing the at least one catheter characteristic, and (c) changing the viscosity of the at least one fluid.

3 . The fluid injection apparatus of claim 2 wherein the at least one model is adapted to receive data from at least one previous injection procedure with the fluid injection apparatus to update the at least one model on the basis of the data from the at least one previous injection procedure with the fluid injection apparatus.

4 . The fluid injection apparatus of claim 3 wherein the at least one model is adapted to receive data from at least one previous injection procedure with another fluid injection apparatus to update the at least one model on the basis of the data from the at least one previous injection procedure with the another fluid injection apparatus.

5 . The fluid injection apparatus of claim 2 wherein the pressure threshold value is set by one of (i) the operator of the fluid injection apparatus and (ii) a manufacturer of the fluid injection apparatus.

6 . The fluid injection apparatus of claim 2 wherein, if it is determined via the at least one model that the pressure threshold value would be reached if the initial injection protocol were carried out, the effecting of a change to update the initial injection protocol as chosen by the operator includes at least one of (i) a flow rate of the at least one fluid, (ii) a concentration of the at least one fluid, (iii) a ratio of one fluid of the at least one fluid to another fluid of the at least one fluid and (iv) a temperature of the at least one fluid.

7 . The fluid injection apparatus of claim 2 wherein the at least one model is determined experimentally for a plurality of fluids of different viscosities and for a plurality of catheters of different gauges used in connection with a plurality of tubing sets, wherein at least one of the plurality of tubing sets is of a like kind to the tubing set.

8 . A method of predicting peak pressure within a fluid path comprising a tubing set and a catheter into which at least one fluid is introduced under pressure by a pressurizing system of a fluid injection apparatus, the method comprising:
(a) inputting an initial injection protocol into the fluid injection apparatus according to which the at least one fluid is intended to be introduced into the fluid path; (b) predicting an expected peak pressure level that would result in the fluid path if the initial injection protocol were to be used as intended to introduce the at least one fluid into the fluid path, the expected peak pressure level being determined before commencement of the initial injection protocol according to at least one model on the basis of a flow rate of the at least one fluid, at least one catheter characteristic, and a viscosity of the at least one fluid, the at least one model being determined experimentally for a plurality of fluids of different viscosities, for a plurality of catheters of different catheter characteristics, and for at least one tubing set of like kind to the tubing set of the fluid path.

9 . The method of claim 8 , further comprising
(c) if the expected pressure level is less than or equal to a pressure threshold value, enabling the initial injection protocol to be used as intended to introduce the at least one fluid into the fluid path; and (d) if the expected pressure level exceeds the pressure threshold value, performing one of:
(I) alerting an operator of the method thereof whereupon the operator is enabled to choose between one of (i) permitting the initial injection protocol to be used as intended to introduce the at least one fluid into the fluid path and (ii) effecting a change to update the initial injection protocol for input into the at least one model; and
(II) automatically effecting a change to update the initial injection protocol to create an updated injection protocol so that the expected pressure level will be determined via the at least one model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be used to introduce the at least one fluid into the fluid path.

10 . The method of claim 9 wherein effecting a change to update the initial injection protocol for input into the at least one model comprises changing the flow rate of the at least one fluid, changing the at least one catheter characteristic, or changing the viscosity of the at least one fluid.

11 . The method of claim 10 further comprising inputting data from at least one previous injection procedure with the fluid injection apparatus into the at least one model and updating the at least one model on the basis of the data from the at least one previous injection procedure with the fluid injection apparatus.

12 . The method of claim 10 further comprising inputting data from at least one previous injection procedure with another fluid injection apparatus into the at least one model and updating the at least one model on the basis of the data from the at least one p

Assignees

• Bayer Healthcare Llc

Inventors

• Kemper Corey

Classifications

• A61M2205/502

  User interfaces, e.g. screens or keyboards · CPC title

• A61M5/007 Primary

  for contrast media · CPC title

• A61M5/16854

  by monitoring line pressure · CPC title

• A61M2205/52

  with memories providing a history of measured variating parameters of apparatus or patient · CPC title

• A61M5/145

  using pressurised reservoirs, e.g. pressurised by means of pistons · CPC title