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WO2008036890A1 - Procédé et dispositif de mesure de l'impédance de tissus et autres matières - Google Patents

Procédé et dispositif de mesure de l'impédance de tissus et autres matières Download PDF

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Publication number
WO2008036890A1
WO2008036890A1 PCT/US2007/079152 US2007079152W WO2008036890A1 WO 2008036890 A1 WO2008036890 A1 WO 2008036890A1 US 2007079152 W US2007079152 W US 2007079152W WO 2008036890 A1 WO2008036890 A1 WO 2008036890A1
Authority
WO
WIPO (PCT)
Prior art keywords
flow
fluid
pressure
downstream
sensing device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/079152
Other languages
English (en)
Inventor
James H. Philip
Thomas Edrich
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Brigham and Womens Hospital Inc
Original Assignee
Brigham and Womens Hospital Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Brigham and Womens Hospital Inc filed Critical Brigham and Womens Hospital Inc
Publication of WO2008036890A1 publication Critical patent/WO2008036890A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3401—Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means

Definitions

  • the present invention relates to a method and device for measuring impedance that the material to be investigated offers to a fluid that is being injected, more particularly the method utilizes two pressure sensors to measure the flow rate through the device.
  • the impedance of the material that the fluid is being injected into can be calculated using the data from these two pressure sensors.
  • One of the usual methods used by anesthesiologists for locating the epidural space involves the injection of saline through needle as the needle is advanced manually past the tissue planes in the back. The anesthesiologist feels a loss of resistance to injection as the needle tip passes into the epidural space. The medication and/or catheter are then inserted through the needle.
  • 5,517,846 and 5,517,846 use the negative pressure to close an electric circuit, thereby providing the user with an alarm.
  • U.S. Patent No. 5,902,273 pressurizes the epidural needle, providing an early warning once the epidural space is entered and also injecting air, thereby pushing the dura away from the needle tip. This may reduce the likelihood of dural puncture.
  • the present invention does not rely on a set flow rate, but instead lets the user determine the flow rate as the syringe plunger on the device is depressed manually by the user.
  • the user retains the manual "feel" associated with injecting fluid into the tissue, while the device simply measures pressures at two points within the device, thereby calculating the instantaneous flow rate and impedance of the tissue.
  • U.S. Patent No. 6,964,204 describes a device used for measurement of flow rate. It includes pressure sensors locally integrated into the device. This device is not described for the measurement of tissue impedance. In contrast to this device, the present invention does not integrate pressure sensors, but rather provides for connection ports to attach clinically approved pressure transducers. Thus, the present invention is less complex to manufacture since it does not require integrated electronics with the inherent risk of exposing the patient to toxins. It can be manufactured from one single material (e.g. PlexiglassTM). Another advantage is that the present invention makes use of already available and FDA- approved pressure transducers. Thus, there are less patient- safety concerns.
  • IV intravenous
  • an IV catheter is inserted into a suitable vein and joined to an injection port.
  • Caregivers can then either inject liquid into the injection port using a syringe (called an "IV bolus"), or attach an IV infusion system consisting of a liquid-filled bag, connection tubing, and an infusion pump that pushes fluid through the connection tubing and into the vein.
  • Administration of the correct fluid volume is critical: In the case of the IV bolus, the caregiver visually checks the gradations on the syringe to verify the volume administered. In the case of an IV infusion, the infusion pump is set to a rate and/or total volume to be infused.
  • One aspect of the present invention is to facilitate the placement of epidural catheters for anesthesia and analgesia.
  • the present invention provides for a easier, and safer epidural placement.
  • the present invention provides for real-time monitoring of the tissue impedance at the end of the needle and gives early warning of correct needle placement. This may be beneficial in the setting of resident training because an attending anesthesiologist can now supervise as the resident handles the epidural needle. But the attending still has an independent monitor to provide reassurance of the correct placement. Thus, the attending physician is less likely to have to take control of the needle. Safety may also be enhanced because dural punctures and the above-described sequel may be less likely. Likewise, risk management may benefit because the care team is likely to encounter fewer complications. Also, scheduling may be faster due to possibly more efficient epidural placement.
  • Yet another aspect of the present invention is to identify tissues for the purpose of obtaining needle biopsies or fluid samples.
  • interventional radiology procedures are guided by imaging such as ultrasound or CT.
  • the needle is advanced under visualization.
  • both ultrasound and CT cast artifacts around a metal needle, obscuring the exact positioning of the tip.
  • the resolution in space of these imaging techniques may not adequately identify the boundary from one tissue to another. For instance, one may wish to obtain a needle biopsy of a liver tissue, but inadvertently advance the needle into a bile duct that is within the liver. Current imaging may not have the necessary spatial resolution to detect this and therefore lead to a useless biopsy.
  • the present invention can more accurately identify the tissue because, for example, the impedance obtained from within the bile duct is quite different from the impedance in the liver parenchyma.
  • Still another aspect of the present invention is to provide a method of identifying a specific structure in interventional radiology, i.e., drainage of cystic or encapsulated fluid collections.
  • the current state of the art is to insert a needle with or without an imaging device or blindly while aspirating in the hope of entering the collection and identifying it by withdrawing the expected fluid through the needle.
  • the method of the present invention facilitates entry into joint capsules for steroid or other medication injection or for diagnostic fluid withdrawal.
  • Another aspect of the present invention provides a method for quantifying tissue impedance as medications, such as local anesthetics, are injected into tissues.
  • Injection of local anesthetic into tissue for anesthesia is usually performed manually with a syringe and needle and is often painful.
  • Commercially available devices for example, The WandTM manufactured by Milestone Scientific Inc., have the ability to limit pressure applied to the tissues during injection, thus limiting pain. However, this is done without explicit calculation of the tissue impedance.
  • the injection occurs at low flow rates that are adjusted to avoid exceeding preset pressure limits regardless of the tissue impedance.
  • the method of the present invention may be able to further reduce the likelihood of pain by measuring the tissue impedance at a low flow rate which lies well below the pain threshold. Thus, the maximum allowable flow rate could be calculated based on this impedance model. This would avoid simple empirical testing of the pain threshold and would avoid sensitizing the patient during the beginning of the injection.
  • Another aspect of the present invention is to provide a method of quantifying the impedance of tissue to more objectively help delineate the borders of a tumor for operative planning in oncology and surgery. Typically, surgeons must anticipate the extent of the tumor tissue by palpitating the tissue intra-operatively.
  • any possible dislodging of the catheter or needle from the desired tissue space may be detected because the impedance may change, thus providing early warning of incorrect fluid delivery.
  • a method for measuring impedance of tissues or other materials resisting injection of fluid comprising the steps of providing a flow sensing device, the flow sensing device including a fluid flow passage and flow restricting element located within the flow passage. Next the fluid to be measured is delivered through the flow passage. At least one pressure sensing element is provided in communication with the flow passage upstream of the flow restricting element and at least one pressure sensing element is provided downstream of the flow restricting element. The flow of the fluid though the flow sensing device is measured using the pressure difference generated due to the flow restricting element. The downstream fluid pressure of the fluid is measured and the hydraulic impedance is computed from the relationship between the measured downstream fluid pressure and the measured fluid flow.
  • the method of the present invention can measure the impedance of living tissue or other material as fluid is delivered via injection needle or catheter.
  • the device includes a proximal chamber that has a port for measurement of hydraulic pressure, followed by a flow restricting element located within the flow passage, and a distal chamber which has another port for measurement of hydraulic pressure.
  • the flow of the fluid though the flow sensing device is calculated using the pressure difference between the distal and proximal ports.
  • the hydraulic impedance is computed from the relationship between the measured downstream fluid pressure and the computed fluid flow.
  • a method of identifying the epidural space around the spinal cord in order to inject fluid medications and/or to place a catheter for the purpose of anesthesia and analgesia comprising the steps of providing a flow sensing device, the flow sensing device including a fluid flow passage and flow restricting element located within the flow passage, and connecting a source of the fluid to an inlet of the flow sensing device.
  • An outlet of the flow sensing device is connected to a medication patient delivery device such as a needle or catheter.
  • the fluid to be measured is delivered through the flow passage.
  • a least one pressure sensing element is provided in communication with the flow passage upstream of the flow restricting element and at least on pressure sensing element is located downstream of the flow restricting element.
  • the flow of the fluid though the flow sensing device is calculated using the pressure differences.
  • the downstream fluid pressure of the fluid is also measured.
  • the hydraulic impedance is computed from the relationship between the measured downstream fluid pressure and the measured fluid flow.
  • the impedance level is monitored to determine the location of medicament patient delivery device, wherein as the epidural space is being entered the impedance will be lowered and an alarm triggered notifying the caregiver to stop advancement.
  • Fig. 1 is a side view of the device of the present invention.
  • Fig. 2 is a perspective view of the system of the present invention.
  • Fig. 3 is a cross-sectional view of the impedance measuring device of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
  • the present invention contemplates a device and method for identifying the impedance of tissues and other substances.
  • the present invention is applicable in numerous settings.
  • an anesthesia care provider can use the system of the present invention to more confidently and quickly identify the epidural space.
  • the present invention is described in relation to locating the epidural space of a patient, other uses are contemplated by the present invention.
  • a short rigid flow and/or impedance sensing device 10 is placed in series between the needle and the syringe.
  • Sensing device 10 has a large diameter with a short resistance piece or stenosis 20.
  • sensing device 10 has attachments 30, 40 to measure the pressure on both sides of stenosis 20.
  • the user injects fluid with the syringe through the impedance sensor 10 and through the needle 60 into the tissue of the patient. Meanwhile, the instantaneous flow rate of the fluid can be calculated from the pressure difference across the resistance 20 according to Poiseuille's effect and the injection pressure can be measured distally to the resistance piece at the port 40.
  • sensing device 10 obtains the flow characteristics as will be described further herein.
  • Sensing device 10 includes a body 12 that has an inlet 14 and an outlet 16. Fluid from the syringe 50 or any other patient medication delivery device, such as an IV 52 (Fig. 2), flows into sensing device 10 via inlet 14 and into a first flow passage 22. From flow passage 22 the fluid flows through flow restricting element/stenosis 20 and into a second flow passage 24. Flow passageways 22, 24 form a flow path through the device. From flow passage 24 the fluid exits sensing device 10 via outlet 16 and into the patient through needle 60.
  • an upstream pressure port 26 is provided to attach the tubing 32 (Fig. 2) leading to a hydraulic pressure sensor 30 (Figs. 2 and 3).
  • the downstream chamber 24 can communicate with a hydraulic pressure sensor 40 (Fig. 2 and 3) via a tubing connection 34 (Fig. 2) to port 28.
  • the pressures can be measured by two single pressure transducers or via a single differential pressure transducer added to on single pressure transducer attached to the distal port 28.
  • pressure sensors can be located within flow passages 22, 24.
  • numerous alternative locations and sensor structures or types can be used and are contemplated by the present invention.
  • the data from pressure sensors 30, 40 can be collected by a microprocessor 70 and used to compute the impedance of the tissue in realtime.
  • the principle of the impedance calculation is that the flow (F) due to the pressure gradient (P 1 -P 2 ) across the impedance Z channe i is the same as the flow through the needle and into the tissue having the impedances Z need i e and Z tlssue . This can be expressed as follows:
  • Z c hannei, Z nee die and Z tlS sue denote the impedances of presented by the channel, needle and tissue.
  • Pi and P 2 are ports meant for a fluid communication with a hydraulic pressure sensor.
  • four quantities must be known to calculate the impedance of the tissue in question: Zchannei, Z nee die, Pi, and P 2 .
  • the impedances Z cn annei and Z nee die are constants, and the pressures Piand P 2 are measured in real-time by pressure transducers 30 and 40 and processed in realtime by microprocessor 70.
  • the second sensor must provide the absolute pressure P 2 which is alone in the numerator as highlighted in equation 3 below:
  • the method of the present invention operates in the following manner. While advancing through the interspinous ligament the flow rate will be very low and the pressure high, corresponding to a high impedance. When the epidural space is entered there will be a sudden change to low pressure, possibly with high flow as the user's fingers respond to the change in tissue (low impedance), triggering an alert. This alert will prompt the user to stop advancing the needle.
  • the physician supervisor will not only be able to witness the loss of resistance by watching the trainee perform the injection, but he will also have a more objective measure by watching the display.
  • the impedance can be converted into an audible signal that would not require visualization, thus allowing the supervisor to watch the trainee continuously.
  • IV intravenous
  • an IV catheter is inserted into a suitable vein and joined to an injection port.
  • Caregivers can then either inject liquid into the injection port using a syringe (called an "IV bolus"), or attach an IV infusion system consisting of a liquid-filled bag, connection tubing, and an infusion pump that pushes fluid through the connection tubing and into the vein.
  • Administration of the correct fluid volume is critical.
  • the caregiver visually checks the gradations on the syringe to verify the volume administered.
  • the infusion pump is set to a rate and/or total volume to be infused.
  • Fluid delivery to the patient can also be continuously monitored whether it is delivered by simple IV infusion or by IV pump (Fig. 2).
  • the device may be connected to the patient with tubing 62 instead of a needle 60 as shown in Fig. 1.
  • the device of the present invention may also be used in conjunction with other features, such as a barcode based syringe-identification system to enhance patient safety and an early alarm system.
  • the method of the present invention can also serve to measure the flow of liquid administered intravenously to a patient. This may be useful in the clinical setting because errors in IV fluid or IV medication administration could be detected.
  • the present invention may also have application in the setting of medical simulation training where a team of medical personnel practice mastering critical events using a life-size manikin. Another environment the system and method of the present invention has application is in the automatic recording of drugs administered in OR, ICU, or other care settings.
  • the present invention can independently quantify the fluid rate and volumes administered by the team to the manikin, and thus lend the simulation a further dimension of realism.
  • Any center for medical simulation could use the present device and method to lend further realism to the simulated scenario.
  • this device could be used to provide surveillance over fluid administration and used by nursing or MD personnel.
  • This device could be incorporated into all Anesthesia Information Management Systems (AIMS) as a direct input of time and quantity of liquid injected. This would serve as a time and drug quantity input to the recording system.
  • AIMS Anesthesia Information Management Systems
  • the present invention also provides additional objective quantitative information about fluid administration. As such, the present invention provides the first practical input to simulated patients and to an AIMS.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un procédé de mesure de l'impédance de tissus ou d'autres matières résistant à l'injection de fluide, comprenant les étapes consistant à utiliser un dispositif de détection d'écoulement, ledit dispositif de détection d'écoulement comportant un passage d'écoulement de fluide à l'intérieur duquel est placé un élément limiteur d'écoulement; à introduire le fluide à mesurer dans le passage d'écoulement; à mettre au moins un élément détecteur de pression en communication avec le passage d'écoulement en amont de l'élément limiteur d'écoulement; à placer au moins un élément détecteur de pression en aval de l'élément limiteur d'écoulement; à mesurer l'écoulement du fluide traversant le dispositif détecteur d'écoulement à partir de la différence de pression créée par l'élément limiteur d'écoulement; à mesurer la pression du fluide en aval; et à calculer l'impédance hydraulique à partir de la relation entre la pression mesurée du fluide en aval et l'écoulement mesuré du fluide.
PCT/US2007/079152 2006-09-22 2007-09-21 Procédé et dispositif de mesure de l'impédance de tissus et autres matières Ceased WO2008036890A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US84635106P 2006-09-22 2006-09-22
US60/846,351 2006-09-22

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WO2008036890A1 true WO2008036890A1 (fr) 2008-03-27

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107666933A (zh) * 2015-04-22 2018-02-06 奇斯药制品公司 用于药物有效地呼吸同步递送到肺部的方法和系统
CN108289997A (zh) * 2015-07-13 2018-07-17 崔亨燦 硬膜外检查点
EP3354311A4 (fr) * 2016-04-25 2019-07-31 Saeum Meditec Co., Ltd Dispositif de détection pour reconnaître l'espace épidural

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4175567A (en) 1976-04-28 1979-11-27 The Kendall Company Method of locating the epidural space
US4898576A (en) 1986-06-06 1990-02-06 Philip James H Intravenous fluid flow monitor
US5087245A (en) 1989-03-13 1992-02-11 Ivac Corporation System and method for detecting abnormalities in intravascular infusion
EP0538259A1 (fr) * 1991-02-28 1993-04-28 Industrias Palex, S.A. Methode et appareil de localisation de cavites anatomiques
US5902273A (en) 1997-10-15 1999-05-11 Yang; Ian Y. Pressurizable epidural space identification syringe
US6158965A (en) 1996-07-30 2000-12-12 Alaris Medical Systems, Inc. Fluid flow resistance monitoring system
US6773417B2 (en) 2001-07-06 2004-08-10 Ispg, Inc. Epidural space locating device
US20040215080A1 (en) * 2001-06-20 2004-10-28 Timotheus Joan Marie Lechner Device and method for locating anatomical cavity in a body
WO2005023359A1 (fr) * 2003-08-29 2005-03-17 Medtronic, Inc. Dispositif d'introduction de sonde de stimulation plate par voie percutanee
US6964204B2 (en) 2003-05-21 2005-11-15 Hospira, Inc. Fluid flow measurement device

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4175567A (en) 1976-04-28 1979-11-27 The Kendall Company Method of locating the epidural space
US4898576A (en) 1986-06-06 1990-02-06 Philip James H Intravenous fluid flow monitor
US5087245A (en) 1989-03-13 1992-02-11 Ivac Corporation System and method for detecting abnormalities in intravascular infusion
EP0538259A1 (fr) * 1991-02-28 1993-04-28 Industrias Palex, S.A. Methode et appareil de localisation de cavites anatomiques
US6158965A (en) 1996-07-30 2000-12-12 Alaris Medical Systems, Inc. Fluid flow resistance monitoring system
US5902273A (en) 1997-10-15 1999-05-11 Yang; Ian Y. Pressurizable epidural space identification syringe
US20040215080A1 (en) * 2001-06-20 2004-10-28 Timotheus Joan Marie Lechner Device and method for locating anatomical cavity in a body
US6773417B2 (en) 2001-07-06 2004-08-10 Ispg, Inc. Epidural space locating device
US6964204B2 (en) 2003-05-21 2005-11-15 Hospira, Inc. Fluid flow measurement device
WO2005023359A1 (fr) * 2003-08-29 2005-03-17 Medtronic, Inc. Dispositif d'introduction de sonde de stimulation plate par voie percutanee

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107666933A (zh) * 2015-04-22 2018-02-06 奇斯药制品公司 用于药物有效地呼吸同步递送到肺部的方法和系统
US20180110948A1 (en) * 2015-04-22 2018-04-26 Chiesi Farmaceutici S.P.A Method and system for effective breath-synchronized delivery of medicament to the lungs
CN108289997A (zh) * 2015-07-13 2018-07-17 崔亨燦 硬膜外检查点
EP3354311A4 (fr) * 2016-04-25 2019-07-31 Saeum Meditec Co., Ltd Dispositif de détection pour reconnaître l'espace épidural

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