WO2022168126A1 - Dispositif de détection directe de variations de pression d'un fluide dans une cavité corporelle - Google Patents

Dispositif de détection directe de variations de pression d'un fluide dans une cavité corporelle Download PDF

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Publication number
WO2022168126A1
WO2022168126A1 PCT/IT2021/000003 IT2021000003W WO2022168126A1 WO 2022168126 A1 WO2022168126 A1 WO 2022168126A1 IT 2021000003 W IT2021000003 W IT 2021000003W WO 2022168126 A1 WO2022168126 A1 WO 2022168126A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
pressure transducer
cannula
fluid
calibration curve
Prior art date
Application number
PCT/IT2021/000003
Other languages
English (en)
Inventor
Florinda Martena
Stefano Trizzino
Original Assignee
Electronic Systems S.P.A.
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 Electronic Systems S.P.A. filed Critical Electronic Systems S.P.A.
Priority to PCT/IT2021/000003 priority Critical patent/WO2022168126A1/fr
Publication of WO2022168126A1 publication Critical patent/WO2022168126A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/16—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A61B5/6821—Eye
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
    • A61B5/032—Spinal fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery

Definitions

  • the present invention relates to the field, of minimally invasive surgical procedures and in particular relates to a detection device capable of directly measuring pressure variations of a fluid within a body cavity.
  • Possible fields of application of the device according to the Invention are. for example. eye surgical procedures. minimally invasive surgical procedures for the abdomen. e.g. laparoscopic. or for the spinal column. in which it is either necessary or appropriate to measure the cerebrospinal fluid pressure.
  • Pressure values above 60 mmHg which corresponds to retinal perfusion pressure. have been reported in phacoemulsification surgical procedures for cataract fragmentation and aspiration . Large pressure variations have also been measured following eyeball manipulation maneuvers in scleral indentation surgical procedures for the treatment of retinal detachment, with peaks of up to 210 mmHg in the case of external pressures applied to the sclera .
  • the variations in intraocular pressure can increase the risk of intraoperative and postoperative complications, such as expulsive hemorrhage, choroid detachment, and retinal ischemia .
  • Expulsive hemorrhage and choroid detachment can be associated with pressure drops during surgery .
  • Prolonged increases in intraocular pressure can result in a reduction in vascular perfusion pressure with consequent impairment of blood flow to the optic nerve and retina .
  • Pressure variations can also adversely affect visual function recovery after the surgical procedure . Indeed, it has been shown that transient increases in ocular perfusion pressure can lead to morphological and functional alterations in the retina .
  • US 4841984 describes a device which relies on direct measurement of intraocular pressure using a pressure transducer integrated on the surgical instrument inserted into the ocular cavity, which is used for fluid infusion or fragmentation and removal of ocular tissue .
  • a control circuit is also present which automatically adjusts the infusion or aspiration of the instrument in response to the measured intraocular pressure, keeping it within the safe range .
  • a first limitation of such a device is the need for a larger ocular incision for the insertion of the instrument and the integrated transducer .
  • a further disadvantage is the proximity of the transducer to the surgical instrument, the operations of which inevitably lead to disturbances and inaccuracies in intraocular pressure measurement .
  • US 20110118729 Al describes a vitrectome coupled to a control circuit for the purpose of enabling or disabling the instrument based on the measured physical parameter .
  • These parameters can include intraocular pressure, which is used to check whether the vitrectome is positioned correctly within the eye socket . Indeed, to activate the vitrectome, the measured pressure must be equal to the fluid infusion pressure but there is no control over pressure variations relative to the set pressure .
  • US 20140171991 Al describes a vit rectome equipped instead with a pressure transducer to monitor the output pressure of the cutting instrument, but no direct monitoring of intraocular pressure is performed.
  • US 2014194834 Al describes a device for controlling the pressure in the eye consisting four elements : a positioning cannula (housed in the anterior chamber of the eye) , a two-way pump
  • This device is thus equipped with an indirect measurement system, which allows the measurement of intraocular pressure only in presence of infusion or aspiration of fluid.
  • This system does not allow the measurement of pressure variations caused by external factors or eyeball manipulation .
  • US 2006/149194 describes a system for treating eye diseases comprising a micro-cannula in which an internal element, configured to exit the distal end of the micro-cannula, can be slidably inserted.
  • the internal element can be used to carry fluids or sensors .
  • US 2008/0082078 Al describes a surgical assembly for treating glaucoma comprising a laser configured to produce an ablation beam of a region of a trabecular meshwork of the eye and a delivery system configured to direct the laser beam from within the eye to the trabecular meshwork of the eye, wherein the delivery system can include pressure detection circuitry to detect and control pressure at the surgical site .
  • WO2016139587A1 describes a surgical assembly for ophthalmic surgical procedures, comprising an optical fiber pressure transducer coupled to a surgical accessory, such as an endoilluminator or infusion cannula, to be jointly inserted into the ocular cavity through an ocular accessory incision .
  • a surgical accessory such as an endoilluminator or infusion cannula
  • figure 1 is a perspective view of the detection device according to the invention, in an embodiment, e . g .
  • reference numeral 1 refers as a whole to a device for the direct detection of pressure variations of a fluid in a first embodiment , e . g . suitable for use during intraocular surgical procedures (as illustrated in figures 3 and 4 ) or lumbar surgical procedures .
  • the device 1 comprises a pressure transducer
  • the pressure transducer 10 is a piezoelectric transducer .
  • the sensing surface 102 is the surface of the piezoelectric material which generates an electrical voltage difference in response to its mechanical deformation .
  • the detection device 1 further comprises a cannula 12 which extends along a cannula axis X between a proximal end 122 and a distal end 124 .
  • the proximal end 122 is placed in direct contact with the sensing surface 102 of the pressure transducer 10 .
  • the distal end 124 either forms or is fizidically coupled to hollow insertion means 14 suitable to be inserted into a body cavity, e . g. the eye socket C .
  • the hollow insertion means [ 0028 ] In an embodiment, the hollow insertion means
  • a needle 142 suitable to pierce the tissues to access the body cavity .
  • the principle of operation of the detection device 1 is based on the fact that the cannula 12 and the hollow insertion means 14 form a volume V containing an air column (or possibly another gas or gas mixture) which is either compressible or decompressible due to a variation in intracavitary pressure .
  • the pressure variation of the air column is suitable to cause mechanical deformation of the sensing surface 102 of the pressure transducer .
  • the cannula 12 is a tubular element which is open at both ends, on the one hand directly to the sensing surface 102 of the pressure transducer and on the other hand to the hollow insertion means 14, which form a port which puts the cannula 12 into communication with the inside of the body cavity .
  • the pressure transducer 10 and the cannula 12 are located externally to the body and it is only the needle 142 which is inserted into the cavity .
  • the cannula 12 has a rigid or semi-rigid body tightly coupled to the pressure transducer 10 .
  • the cannula 12 can be a gripping element of the detection device 1 during use .
  • the cannula 12 and the pressure transducer 10 can be made such that the cannula 12 itself also serves as a support for the pressure transducer 10 .
  • the detection device 1 can be formed only of the pressure transducer 10 and the cannula-needle assembly and be connected to a control apparatus 40 only by electrical wires 4 .
  • the detection device 1 can be extremely light and easy to handle .
  • the distal end 124 of the cannula 12 is coupled to a blunt needle 16.
  • the distal end 124 of the cannula 12 is connected to the needle 14 ; 16 by means of a Luer lock type connector 18 .
  • the needle 14 ; 16 is inserted into a guiding cannula 20 of a trocar .
  • the piezoelectric transducer 10 has a sensing surface 102 which extends predominantly on a plane substantially orthogonal to the cannula axis (X) . In this manner, the pressure variation of the air column within the volume V generates a strain on the sensing surface 102 with a prevailing component orthogonal to the sensing surface
  • Figures 5-7 show a detection device 200 in another embodiment suitable, for example, for laparoscopic surgical procedures .
  • the detection device 200 can use the same pressure transducer 10 described above coupled to the cannula 12 .
  • the cannula 12 in this case, is suitable to interface directly with a guiding cannula 220 of a trocar, instead of with a needle, as illustrated in figure 7 .
  • the guiding cannula 220 of the trocar thus constitutes the hollow insertion means 14.
  • the cannula 12 comprise a proximal portion 12a, a distal portion 12b, which is larger in diameter than the diameter of the proximal portion 12a, and an intermediate portion 12c connecting the proximal portion 12a and the distal portion 12b .
  • the proximal portion 12a ends with the proximal end 122 in direct contact with the sensing surface 102 .
  • the distal portion 12b is suitable to be fluid-tightly inserted into the inlet port 222 of the guiding cannula 220 .
  • the distal portion 12b has a diameter corresponding to that of the inlet port 222 of the guiding cannula, the trocar for laparoscopic surgical procedures being larger than, for example, trocars for ocular or lumbar surgical procedures .
  • the pressure transducer 10 is associated with a theoretical calibration curve, i . e . , obtained in a clean room, thus in the absence of any disturbance or perturbation .
  • the pressure transducer 10 is used in the operating room, in close proximity to the patient ’ s eye .
  • the calibration system 30 comprises a second pressure transducer 10a which is identical to the pressure transducer of the intraocular pressure sensing device 10 .
  • a tubular container 32 is fluid-tight ly coupled to the second pressure transducer 10a .
  • This tubular container 32 is suitable to contain a calibration fluid, e . g . a saline solution, so that the calibration fluid applies a predetermined and invariable reference pressure on the sensing surface of the second pressure transducer 10a .
  • a calibration fluid e . g . a saline solution
  • the calibration system 30 includes a control unit 34 configured to perform the steps of : calculating a calibration curve off-set as the difference between the electrical voltage value generated by the second pressure transducer 10a at the reference pressure and the voltage value corresponding to the reference pressure in the theoretical calibration curve; summing the calculated calibration curve offset to all values of the theoretical calibration curve .
  • the calibration system 30 provides an offset reference for self-calibration of the system-preloaded calibration curve of the pressure transducer 10 to be connected to the eye .
  • Such a differential configuration in addition to avoiding calibration procedures when opening the surgical kit, cancels stochastic noise and measurement disturbances to the benefit of the accuracy of the detection device
  • the pressure transducers 10, 10a are calibrated in a clean room at the end of production; the second transducer 10a (subjected to a fixed pressure given by the weight of a predetermined column of the calibration fluid, e . g . a saline solution) updates the offset of the calibration curve of the first pressure transducer 10, to correct the drifts from a variation of environmental conditions between the clean room and the operating room.
  • the second transducer 10a (subjected to a fixed pressure given by the weight of a predetermined column of the calibration fluid, e . g . a saline solution) updates the offset of the calibration curve of the first pressure transducer 10, to correct the drifts from a variation of environmental conditions between the clean room and the operating room.
  • offset voltage value of the reference system at 20 mmHg voltage value at 20 mmHg in the calibration curve .
  • the calibration system 30 is housed in the same control apparatus 40 to which the detection device 1 ; 200 which measures the pressure variation is operatively connected.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

Un dispositif de détection directe de variations de pression d'un fluide dans une cavité corporelle comprend un transducteur de pression et une canule ayant une extrémité distale qui forme ou est en communication fluidique avec des moyens d'insertion creux appropriés pour être insérés dans la cavité corporelle. La canule et le moyen d'insertion creux forment un volume qui contient une colonne d'air qui peut être comprimée ou décomprimée par une variation de pression du fluide à l'intérieur de la cavité corporelle, la variation de pression de la colonne d'air étant appropriée pour provoquer une déformation mécanique de la surface de détection.
PCT/IT2021/000003 2021-02-08 2021-02-08 Dispositif de détection directe de variations de pression d'un fluide dans une cavité corporelle WO2022168126A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IT2021/000003 WO2022168126A1 (fr) 2021-02-08 2021-02-08 Dispositif de détection directe de variations de pression d'un fluide dans une cavité corporelle

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2021/000003 WO2022168126A1 (fr) 2021-02-08 2021-02-08 Dispositif de détection directe de variations de pression d'un fluide dans une cavité corporelle

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WO2022168126A1 true WO2022168126A1 (fr) 2022-08-11

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4127110A (en) * 1976-05-24 1978-11-28 Huntington Institute Of Applied Medical Research Implantable pressure transducer
WO1990011717A1 (fr) * 1989-03-31 1990-10-18 Utah Medical Products, Inc. Appareil de mesure de la pression dans des cavites du corps
US5312354A (en) * 1991-11-04 1994-05-17 American Cyanamid Company Safety trocar instrument having a retractable point actuated by a trigger sleeve
CN211749569U (zh) * 2018-03-07 2020-10-27 中国人民解放军第四军医大学 一种一次性使用血压传感器

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4127110A (en) * 1976-05-24 1978-11-28 Huntington Institute Of Applied Medical Research Implantable pressure transducer
WO1990011717A1 (fr) * 1989-03-31 1990-10-18 Utah Medical Products, Inc. Appareil de mesure de la pression dans des cavites du corps
US5312354A (en) * 1991-11-04 1994-05-17 American Cyanamid Company Safety trocar instrument having a retractable point actuated by a trigger sleeve
CN211749569U (zh) * 2018-03-07 2020-10-27 中国人民解放军第四军医大学 一种一次性使用血压传感器

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