WO2001013789A1 - Improvements relating to catheter positioning - Google Patents
Improvements relating to catheter positioning Download PDFInfo
- Publication number
- WO2001013789A1 WO2001013789A1 PCT/GB2000/003266 GB0003266W WO0113789A1 WO 2001013789 A1 WO2001013789 A1 WO 2001013789A1 GB 0003266 W GB0003266 W GB 0003266W WO 0113789 A1 WO0113789 A1 WO 0113789A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- pressure
- fluid
- piping
- organ
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
- A61B5/02158—Measuring pressure in heart or blood vessels by means inserted into the body provided with two or more sensor elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/026—Measuring blood flow
- A61B5/0275—Measuring blood flow using tracers, e.g. dye dilution
- A61B5/028—Measuring blood flow using tracers, e.g. dye dilution by thermo-dilution
Definitions
- the present invention relates to improvements for the positioning of catheters monitoring cardiac output data.
- US 5509424 describes a catheter having a heat transfer device near its distal end for use in monitoring cardiac output within an artery.
- the apparatus determines cardiac output using selected features derived from a temperature difference signal based on measurement of average native blood temperature detected at a proximal temperature sensor from the temperature of a heating coil detected by a distal temperature sensor.
- the tip of a catheter after normal flotation of the catheter into the main pulmonary artery (PA) , could be between 0-8 cm in the left or right main branch of the PA.
- PA main pulmonary artery
- this positioning is acceptable.
- the position of the heat transfer element (HTD) is critical. If the HTD is located in a branch, then it will sense part of the flow giving a lower CO. Also if the HTD is near high turbulence, for example, near a valve or bifurcation, it would give higher CO. Hence it is important to control the position of HTD in order to improve the overall accuracy of CO determination.
- One design of a cathater according to US 5509424 has a heat transfer device located at 7.5 cm from the distal tip (figure 1) . This will ensure, based on the clinical study mentioned above, that the HTD would not be in a branch in 95% of the cases. However, based on one clinical study in 20 patients, there appeared to be a position influence in about 20-30% of the time (CO determined by heat transfer was significantly lower than CO determined by thermal dilution) . It is an object of the present invention to provide apparatus and method for a catheter for positional information.
- a catheter which includes means to measure local pressure at two or more points along the catheter body .
- the points are preferably located in two different pressure areas.
- the catheter preferably has a heat transfer device thereon, more preferably at or near its distal end.
- the pressure measuring means may be fluid filled lumens which allow transmission of a pressure waveform to a pressure transducer which may be located outside the patient.
- pressure transduction means may be located at these points and the signal transmitted via electrical cables, fluid or fibre optic.
- the transduction means itself may be optical, semiconductor or some other means.
- the pressure measuring means may be identical or different. The transmission could pass along only one lumen.
- the measuring means is preferably two or more pressure measuring devices such as diaphragms located along the length of the catheter body.
- the information from the different pressure measuring means can be referenced and calculated to indicate the position of the catheter, more particularly the catheter tip and any heat transfer device, in a blood vessel, organ or similar.
- the catheter could use an existing lumen or includes an additional lumen to relay the information from the pressure measuring means to its proximal end.
- a method of gauging the positional location of a catheter in a blood vessel, organ or similar having means to monitor the local pressure at two or more points along the catheter body, wherein the catheter is located along two different pressure areas, and the pressure differential measurements between the points in the two different areas is indicative of the location of the catheter.
- the pressure detecting means of the present invention could be located across a valve in a blood vessel, organ or similar, eg the heart.
- one pressure detecting means is located in the pulmonary artery, and one pressure detecting means is located in an adjoining ventricle.
- the known different pressures of the blood in the pulmonary artery and the ventricle will create a pressure differential, and with knowledge of the artery pressure at the valve, the pressure differential information can be used to ensure that the catheter tip and heat transfer device is located where desired, eg whether the tip is in the atrium, the ventricle or in the pulmonary artery.
- a catheter according to the present invention will have means to locate pressure points so that the heat transfer device is in the centre of the main pulmonary artery.
- a method of gauging the positional location of a catheter in a blood vessel, organ or similar the catheter having means to monitor the local pressure at a point along the catheter body, wherein the catheter is located in a first position in the vessel, organ or similar, and the local pressure measured, and the catheter is then moved to a second position in the vessel, organ or similar, and the local pressure measured, and the pressure measurements at the first and second locations are indicative of the location of the catheter.
- This method would use only one pressure measuring means to detect the pressure waveforms. This allows minimising the size of a catheter for applications requiring the least possible outer diameter, for example in paediatric or neonatal cardiovascular system.
- the catheter would be moved forward until the indicative pressure waveform (measured by the pressure measuring means) changed indicating that the sensor had crossed a valve.
- the catheter could then be withdrawn until the valve is crossed again, to confirm the position. In this way any part of the catheter at fixed, known distances from the pressure sensing means can have location known relative to the position of the valve.
- the catheter could have calibrated distance markings on its outer surface to assist in accurate determination of insertion and withdrawal distances.
- a catheter which includes internal fluid piping whose fluid pressure is relatable to the general pressure of surrounding fluid external to the catheter, and at least one means to measure the fluid pressure in the internal piping.
- the piping could directly use a portion of the fluid surrounding the catheter.
- the piping could relay information from an external pressure measuring means such as a diaphragm.
- the catheter preferably has a heat transfer device at or near its distal end.
- Figure 1 is a cross-sectional view through part of a first catheter according to the present invention
- Figure 2 is a cross-sectional view through a part of a second catheter according to the present invention.
- Figure 3 shows R.V. and PA traces provided by the catheter shown in Figure 2.
- Figure 4 illustrates positioning of a Pulmonary Artery Catheter.
- Figure 1 is a cross sectional view of a section of a first catheter 2, having an internal fluid piping 4. Each end of the piping 4 is covered by a diaphragm 6 aligned with the catheter outer wall 8.
- the piping 4 is filled with a fluid 10 such as a sterile saline solution or gel.
- the fluid should be non-toxic and bio-compatible.
- a third diaphragm 11 connected to a pressure sensor (not shown) at the end of a lumen 14.
- this section of the catheter 2 is intended to be located across a differential pressure boundary (dashed line A-A) such as a heart ventricle valve, such that the pressure on one of the end diaphragms 6 of the piping 4 is different to that on the other.
- a differential pressure boundary dashed line A-A
- the different pressures on the end diaphragms 6 will result (through the internal fluid 10) in movement of the intermediate diaphragm 11, and movement of this diaphragm 11 can be measured by the pressure sensor.
- Figure 2 shows a second catheter body 12 which has two measuring means 13, 14, with respective waveform transmissions means 13a, 14a.
- the dashed line BB indicates a pulmonary valve.
- the pressure waveform trace measured at position 13 would be as shown in Figure 3; the waveform indicative of the right ventricle, R.V.
- position 14 would show the waveform indicative of the pulmonary artery PA also shown in Figure 3.
- the catheter 12 was so positioned as to give these respective waveforms the user would know the location of the pressure measuring means 13, 14 and hence the location of any other part of the catheter 12 which is a fixed distance along the catheter from those means. For example, if the distal tip 16 was 10 cm from point 14, then the user would know that the tip was approximately 10 cm from the pulmonary valve.
- a heat transfer device 15 located for example 1cm from point 14.
- Figure 4 illustrates positioning of a pulmonary artery catheter.
- the catheter (2) extends through the Superior Vena Cava (17) , into the Right Atrium (18) , into the Right Ventricle (19) , into the Main Pulmonary Artery (20) and into the Right Pulmonary Branch (21) .
- Use of pressure detecting means allows the heat transfer device to be positioned in the main pulmonary artery.
- the present invention provides two approaches for actual clinical practice
- a current catheter according to US Patent No 5509424 has a cross section having 6 lumens described as follows:
- the proximal injectate lumen terminates at a port located 30 cm from the distal tip.
- the proximal injectate port resides in the right atrium or vena cava, allowing for bolus cardiac output injections, right arterial pressure monitoring, blood sampling, or infusion of solutions.
- the pulmonary artery (PA) distal infusion lumen terminates at the distal tip.
- this port is used to monitor catheter location, via transitional pressure measurements.
- this port resides in the pulmonary artery, (allowing for pulmonary artery and pulmonary capillary wedge pressure measurements) or mixed venous blood sampling. This port also allows for infusion of solutions, pressure monitoring or blood sampling.
- the distal and proximal thermistor lumens contain the electrical leads for the thermistors, which are positioned on the catheter surface, approximately 7.5 cm and 11 cm respectively from the distal tip.
- the thermistors are used to measure temperatures and in conjunction with the thermal coil, generate data used to calculate cardiac output.
- the distal thermistor is located immediately below the thermal coil.
- the thermal coil lumen contains leads for the thermal coil, which is located 7.5 cm from the distal tip.
- the thermal coil generates heat necessary for maintenance of a constant temperature differential between the proximal and distal thermistors.
- the energy required to maintain the fixed temperature differential is used to calculate cardiac output continuously.
- the balloon inflation lumen has a one-way stopcock at its proximal end and terminates in a latex balloon at the distal tip.
- the balloon is inflated intermittently for the measurement of pulmonary artery wedge pressure.
- the balloon is inflated by a volume restricted syringe .
- two lumens become available to be used for pressure monitoring.
- PCI heat transfer device
- PC2 right ventricular waveform
- Another approach would be to vacate only one lumen to use only one slot either below or above the HTD.
- the catheter can be advanced until this pressure slot shows a PA trace, then it is withdrawn slightly (e.g. 1 cm increments) until an RV trace is obtained.
- the HTD will then be in the main PA just after the pulmonic valve.
- the slot is placed 2 cm above the HTD.
- withdraw catheter until an RV trace is observed, then advance 4 cm into PA.
- the HTD is then in the main PA above the pulmonic valve .
- the present invention can be used to more accurately have knowledge of the position of the catheter in a blood vessel, organ or similar.
- the catheter includes a heat transfer device
- the position of the heat transfer device can be more accurately calculated, and thus the nature of the heat measurements and associated cardiac information can be more accurately determined.
- the last point is relevant to any pulmonary artery catheter. It is important for the wellbeing of patients that the tip of any pulmonary artery catheter is not allowed too far beyond the pulmonary valve.
- novel apparatus and methods of the present invention could also be used in non-medical fields requiring accurate positioning of elongate tubing and the like in remote locations.
- Such fields include aeronautics, any fluid flow analysis, food and drink processing and monitoring, water and sewerage management, chemical engineering, fuel supply to engines, etc.
- the present invention is also applicable to any device required to be placed beyond a one-way valve in a fluid flow situation, and/or any fluid flow situation which exhibits a pressure differential.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NZ517437A NZ517437A (en) | 1999-08-26 | 2000-08-25 | Improvements relating to catheter positioning |
AU70188/00A AU7018800A (en) | 1999-08-26 | 2000-08-25 | Improvements relating to catheter positioning |
MXPA02002088A MXPA02002088A (en) | 1999-08-26 | 2000-08-25 | Improvements relating to catheter positioning. |
JP2001517935A JP2003507111A (en) | 1999-08-26 | 2000-08-25 | Improvements in catheter positioning |
EP00958766A EP1207783A1 (en) | 1999-08-26 | 2000-08-25 | Improvements relating to catheter positioning |
CA002382222A CA2382222A1 (en) | 1999-08-26 | 2000-08-25 | Improvements relating to catheter positioning |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9920104.8A GB9920104D0 (en) | 1999-08-26 | 1999-08-26 | Improvements relating to catheters (II) |
GB9920104.8 | 1999-08-26 | ||
US15334199P | 1999-09-10 | 1999-09-10 | |
US60/153,341 | 1999-09-10 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2001013789A1 true WO2001013789A1 (en) | 2001-03-01 |
Family
ID=26315878
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2000/003266 WO2001013789A1 (en) | 1999-08-26 | 2000-08-25 | Improvements relating to catheter positioning |
Country Status (6)
Country | Link |
---|---|
EP (1) | EP1207783A1 (en) |
AU (1) | AU7018800A (en) |
CA (1) | CA2382222A1 (en) |
MX (1) | MXPA02002088A (en) |
NZ (1) | NZ517437A (en) |
WO (1) | WO2001013789A1 (en) |
Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003053237A3 (en) * | 2001-12-20 | 2003-10-30 | Scimed Life Systems Inc | Pressure-sensing guidewire and sheath |
FR2839438A1 (en) * | 2002-04-26 | 2003-11-14 | E Med Biotech Inc | SPHYGMOGRAPHY AND DEVICE FOR MEASURING PRESSURE AND BLOOD FLOW. |
WO2010064043A1 (en) | 2008-12-03 | 2010-06-10 | Omega Critical Care Limited | Method and device for determining dysfunction of the heart |
WO2014065969A1 (en) * | 2012-10-25 | 2014-05-01 | Medrad, Inc. | Catheters and related equipment |
US9504392B2 (en) | 2011-10-28 | 2016-11-29 | Three Rivers Cardiovascular Systems Inc. | Apparatus, system and methods for measuring a blood pressure gradient |
JP2016209008A (en) * | 2015-04-28 | 2016-12-15 | フクダ電子株式会社 | Cardiac catheter testing device and site discrimination method |
US9539090B2 (en) | 2014-01-16 | 2017-01-10 | Cook Medical Technologies Llc | Transaortic valve access device |
US9567363B2 (en) | 2007-10-16 | 2017-02-14 | Otsuka Pharmaceutical Co., Ltd. | Certain compounds, compositions and methods |
GB2544989A (en) * | 2015-12-02 | 2017-06-07 | Diasolve Ltd | Insert devices for pressure compensation |
US10463259B2 (en) | 2011-10-28 | 2019-11-05 | Three Rivers Cardiovascular Systems Inc. | System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization |
US10722175B2 (en) | 2014-07-13 | 2020-07-28 | Hemocath Ltd. | System and apparatus comprising a multisensor guidewire for use in interventional cardiology |
US10850066B2 (en) | 2006-04-21 | 2020-12-01 | Bayer Healthcare Llc | Catheters and related equipment |
US11272847B2 (en) | 2016-10-14 | 2022-03-15 | Hemocath Ltd. | System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3995623A (en) * | 1974-12-23 | 1976-12-07 | American Hospital Supply Corporation | Multipurpose flow-directed catheter |
US4680957A (en) * | 1985-05-02 | 1987-07-21 | The Davey Company | Non-invasive, in-line consistency measurement of a non-newtonian fluid |
EP0297675A1 (en) * | 1987-06-30 | 1989-01-04 | Stichting Foundation For The Administration Of Patent Rights Of Dr. H. Goslinga Et Al | Flow-directed balloon catheter for carrying out hemodynamic measurements on a patient |
US4815472A (en) * | 1987-06-01 | 1989-03-28 | The Regents Of The University Of Michigan | Multipoint pressure-sensing catheter system |
EP0363117A1 (en) * | 1988-10-06 | 1990-04-11 | Baxter International Inc. | A position-monitoring flow-directed catheter and method |
US5025786A (en) * | 1988-07-21 | 1991-06-25 | Siegel Sharon B | Intracardiac catheter and method for detecting and diagnosing myocardial ischemia |
WO1995005114A1 (en) * | 1993-08-19 | 1995-02-23 | Bard Fiberoptic Technologies, Inc. | Dual pressure sensing catheter |
WO1996032056A2 (en) * | 1995-04-14 | 1996-10-17 | Erik Billiet | System for the measurement of continuous cardiac output |
-
2000
- 2000-08-25 WO PCT/GB2000/003266 patent/WO2001013789A1/en not_active Application Discontinuation
- 2000-08-25 EP EP00958766A patent/EP1207783A1/en not_active Withdrawn
- 2000-08-25 CA CA002382222A patent/CA2382222A1/en not_active Abandoned
- 2000-08-25 NZ NZ517437A patent/NZ517437A/en unknown
- 2000-08-25 AU AU70188/00A patent/AU7018800A/en not_active Abandoned
- 2000-08-25 MX MXPA02002088A patent/MXPA02002088A/en unknown
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3995623A (en) * | 1974-12-23 | 1976-12-07 | American Hospital Supply Corporation | Multipurpose flow-directed catheter |
US4680957A (en) * | 1985-05-02 | 1987-07-21 | The Davey Company | Non-invasive, in-line consistency measurement of a non-newtonian fluid |
US4815472A (en) * | 1987-06-01 | 1989-03-28 | The Regents Of The University Of Michigan | Multipoint pressure-sensing catheter system |
EP0297675A1 (en) * | 1987-06-30 | 1989-01-04 | Stichting Foundation For The Administration Of Patent Rights Of Dr. H. Goslinga Et Al | Flow-directed balloon catheter for carrying out hemodynamic measurements on a patient |
US5025786A (en) * | 1988-07-21 | 1991-06-25 | Siegel Sharon B | Intracardiac catheter and method for detecting and diagnosing myocardial ischemia |
EP0363117A1 (en) * | 1988-10-06 | 1990-04-11 | Baxter International Inc. | A position-monitoring flow-directed catheter and method |
WO1995005114A1 (en) * | 1993-08-19 | 1995-02-23 | Bard Fiberoptic Technologies, Inc. | Dual pressure sensing catheter |
WO1996032056A2 (en) * | 1995-04-14 | 1996-10-17 | Erik Billiet | System for the measurement of continuous cardiac output |
Cited By (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8668650B2 (en) | 2001-12-20 | 2014-03-11 | Boston Scientific Scimed, Inc. | Pressure-sensing guidewire and sheath |
US9113790B2 (en) | 2001-12-20 | 2015-08-25 | Boston Scientific Scimed, Inc. | Pressure-sensing guidewire and sheath |
WO2003053237A3 (en) * | 2001-12-20 | 2003-10-30 | Scimed Life Systems Inc | Pressure-sensing guidewire and sheath |
FR2839438A1 (en) * | 2002-04-26 | 2003-11-14 | E Med Biotech Inc | SPHYGMOGRAPHY AND DEVICE FOR MEASURING PRESSURE AND BLOOD FLOW. |
US10850066B2 (en) | 2006-04-21 | 2020-12-01 | Bayer Healthcare Llc | Catheters and related equipment |
US9567363B2 (en) | 2007-10-16 | 2017-02-14 | Otsuka Pharmaceutical Co., Ltd. | Certain compounds, compositions and methods |
WO2010064043A1 (en) | 2008-12-03 | 2010-06-10 | Omega Critical Care Limited | Method and device for determining dysfunction of the heart |
US10463259B2 (en) | 2011-10-28 | 2019-11-05 | Three Rivers Cardiovascular Systems Inc. | System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization |
US9504392B2 (en) | 2011-10-28 | 2016-11-29 | Three Rivers Cardiovascular Systems Inc. | Apparatus, system and methods for measuring a blood pressure gradient |
US11197619B2 (en) | 2011-10-28 | 2021-12-14 | Three Rivers Cardiovascular Systems Inc. | System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization |
WO2014065969A1 (en) * | 2012-10-25 | 2014-05-01 | Medrad, Inc. | Catheters and related equipment |
US9539090B2 (en) | 2014-01-16 | 2017-01-10 | Cook Medical Technologies Llc | Transaortic valve access device |
US10722175B2 (en) | 2014-07-13 | 2020-07-28 | Hemocath Ltd. | System and apparatus comprising a multisensor guidewire for use in interventional cardiology |
JP2016209008A (en) * | 2015-04-28 | 2016-12-15 | フクダ電子株式会社 | Cardiac catheter testing device and site discrimination method |
GB2544989A (en) * | 2015-12-02 | 2017-06-07 | Diasolve Ltd | Insert devices for pressure compensation |
US11272847B2 (en) | 2016-10-14 | 2022-03-15 | Hemocath Ltd. | System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization |
Also Published As
Publication number | Publication date |
---|---|
NZ517437A (en) | 2004-02-27 |
CA2382222A1 (en) | 2001-03-01 |
EP1207783A1 (en) | 2002-05-29 |
AU7018800A (en) | 2001-03-19 |
MXPA02002088A (en) | 2003-09-22 |
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