WO2016150754A1 - Système de phacoémulsification - Google Patents

Système de phacoémulsification Download PDF

Info

Publication number
WO2016150754A1
WO2016150754A1 PCT/EP2016/055500 EP2016055500W WO2016150754A1 WO 2016150754 A1 WO2016150754 A1 WO 2016150754A1 EP 2016055500 W EP2016055500 W EP 2016055500W WO 2016150754 A1 WO2016150754 A1 WO 2016150754A1
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WO
WIPO (PCT)
Prior art keywords
flow
pump
pressure
aspiration
flow pump
Prior art date
Application number
PCT/EP2016/055500
Other languages
German (de)
English (en)
Inventor
Christoph KÜBLER
Original Assignee
Carl Zeiss Meditec Ag
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 Carl Zeiss Meditec Ag filed Critical Carl Zeiss Meditec Ag
Publication of WO2016150754A1 publication Critical patent/WO2016150754A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00736Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00745Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/77Suction-irrigation systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0612Eyes

Definitions

  • the invention relates to a phacoemulsification system.
  • phacoemulsification In which a thin needle is inserted into the eye lens and excited to vibrate with ultrasound. The vibrating needle emulsifies in its immediate vicinity the lens such that the resulting lens particles can be sucked through a conduit by means of a pump.
  • a flushing fluid Irrigati- onsfluid
  • a new artificial lens can be inserted into the empty capsular bag so that a patient treated in this way can regain good vision.
  • the resulting suction can cause not only small particles and fluid to be drawn to the aspiration needle, but also a portion of the capsular bag to come into contact with the needle. If the capsular bag is punctured, this leads to considerable complications for the patient, which must be avoided at all costs.
  • the peristaltic pump could be operated in such a way that it aspirates aspiration fluid and particles, for example with a high number of revolutions, so that a relatively high negative pressure is created in the aspiration line. Although this could achieve a faster emulsification of the lens, but then the intraocular pressure would drop significantly. A low intraocular pressure is dangerous because the eye can easily collapse at low pressure and, for example, the pupil can be made to feel a noticeable vibration.
  • US 2002/0019607 A1 describes an irrigation system for a medical device.
  • the system may have a control device which is provided with an irri- coupled and a pressure sensor which measures the pressure in an irrigation line.
  • the control device With the control device, the speed of the pump can be varied as a function of the measured pressure in the irrigation line. It is an object of the invention to provide a phacoemulsification system with which it is possible to significantly reduce or even completely compensate for very rapidly occurring fluctuations in intraocular pressure during phacoemulsification in a simple and cost-effective manner. This object is solved by the subject matter of the independent claim.
  • Advantageous developments of the invention are the subject of the dependent claims.
  • the inventive phacoemulsification system has:
  • an irrigation fluid container for receiving irrigation fluid
  • an aspiration pump for aspiration fluid aspiration for aspiration fluid aspiration
  • the phacoemulsification system thus comprises, inter alia, a flow pump through which the irrigation fluid from the irrigation fluid container is conveyed through the irrigation fluid reservoir. can flow fluid line to the flow pump.
  • a flow pump is advantageous because with it very quickly a speed change and thus volume flow change can be achieved up to a maximum value.
  • a maximum volume flow of 150 ml / s required for phacoemulsification can be achieved by using a flow pump in less than 10 milliseconds. This means that by driving the flow pump very quickly a change in the volume flow in the irrigation line and very quickly a change in the pressure within the eye is possible.
  • a flow pump is advantageous because no complex pneumatic or hydraulic pressure controls, pressure chambers or valves must be controlled and operated.
  • the change in the volume flow in the irrigation line or the pressure in the eye takes place in the inventive Phakoemulstechnischssystem only by a change in the speed of the flow pump.
  • the control of such a flow pump can be easily and safely controlled and monitored, for example by means of a digital tachometer.
  • a flow pump can be installed directly in a cassette, which is used in a console of a Phakoemulstechnischssystems.
  • the distance to an eye to be treated is relatively short, so that only a small tube length to a handpiece is required, which has a vibrating needle for emulsification of the eye and supplies irrigation fluid to the eye.
  • a rapidly occurring fluctuation of the intraocular pressure to a dangerously low pressure level can be compensated for by the phacoemulsification system according to the invention by means of a rapid supply of irrigation fluid by use of a flow pump.
  • the control device according to the invention is adapted to adjust the speed of the flow pump with a frequency in the range of 0 to 10 hertz, wherein the Flow pump builds up a dynamic overpressure of up to 0.5 bar. This can also compensate for the pressure fluctuations in the irrigation line occurring during short occlusion processes.
  • the flow pump is integrated in the irrigation line. Irrigation fluid flows directly and indirectly through the flow pump. So there is no bypass or a similar diversion with valves and associated control required. This is additionally advantageous since no time is needed for actuating valves, so that an even higher level of safety can be counteracted by a dangerous pressure fluctuation in the eye of a patient.
  • the Irrigationsfluid employer is not adjustable during a Phakoemu 1 si fikati on in its height. This ensures that there is always a previously set height and thus a previously set hydrostatic pressure. If there is no occlusion during phacoemulsification and therefore no subsequent occlusion breakthrough, a volumetric flow is sufficient, as it results from the hydrostatic pressure at a predetermined height of the irrigation fluid container. The flow pump is then permeable even without control for this relatively small volume flow. If an occlusion breakthrough is present, an additional volume flow can be added in a very short time to this existing by the hydrostatic pressure flow rate by means of the flow pump. The hydrostatic pressure acts as an offset for the flow pump. Due to the fixed height of the Irrigationsfluid mattersers can thus be dispensed with a complex rack drive with damping, as is usual in a phacoemulsification system according to the prior art.
  • the flow pump can be controlled by means of a magnetic coupling.
  • a magnetic coupling allows driving a flow wheel of the flow pump without direct mechanical connection. This makes it possible to skilfully deal with problems with a seal.
  • a magnetic coupling allows a safe non- invasive operation of the flow pump, which is very advantageous in terms of sterility of Irrigations- fluid.
  • control device of the phacoemulsification system is set up to control the flow pump such that the volume flow generated by the flow pump in the irrigation line is proportional to the volume flow in the aspiration line.
  • the flow pump is a centrifugal pump.
  • a centrifugal pump fluid is supplied to a hub of an impeller of the centrifugal pump and thrown by centrifugal force to an edge of the impeller. There is a conversion of the kinetic energy into a pressure energy.
  • Such a pump is suitable for changing the volume flow and the pressure of the fluid to be delivered.
  • a centrifugal pump is advantageous in the phacoemulsification system according to the invention, since it is simple and robust and, moreover, enables speeds of up to 10,000 revolutions per minute and a very rapid change in the volume flow and the pressure of the fluid to be delivered.
  • FIG. 1 shows a schematic representation of a phacoemulsification system according to the invention
  • FIG. 2 shows a schematic representation of signal curves as a function of time for a volume flow in an aspiration line, a suction pressure in an aspiration line, an intraocular pressure in a phacoemulsification system according to the prior art, a rotational speed of a flow pump and an associated volume flow of the flow pump and a fluid pressure the flow pump in one embodiment of the invention Phakoemulsifi- kationsssystems, and an intraocular pressure when using the Phakoemulstechnischssystems invention;
  • FIG. 3 shows a diagram with a profile of the intraocular pressure as a function of the rotational speed of the flow pump
  • Fig. 5 is a graph showing a curve with respect to the pressure generated by the flow pump as a function of time in the preferred embodiment.
  • FIG. 1 shows a schematic representation of an embodiment of the phacoemulsification system 200 according to the invention.
  • An irrigation fluid container 1 contains an irrigation fluid 2, which can flow off through an irrigation line 3.
  • the irrigation fluid 2 reaches a flow pump 4, which is integrated in the irrigation line 3.
  • the irrigation fluid 2 flows through the flow pump 4 and reaches a handpiece 5 with a ultrasound in the longitudinal direction oscillating needle 6 for emulsification of an eye lens 7 to be treated eye 8.
  • the emulsified lens particles and associated fluid are removed by an aspiration line 9, the suction pressure is generated by an aspiration pump 10.
  • the extracted lens particles and the fluid are collected in a collecting container 11, which is arranged downstream of the aspiration pump 10.
  • a volume flow in the aspiration line 9 or a pressure in the aspiration line 9 is detected, so that from this device 12, a volume flow signal 13 or a pressure signal 14 is generated.
  • the volume flow signal 13 or pressure signal 14 is then passed to a control device 15 and received by this.
  • the control device 15 is set up to send a control signal 16 to the flow pump 4, so that a change in the volume flow or the pressure in the irrigation line 3 takes place.
  • the volume flow signal 13 can be determined by means of a volume flow sensor or by means of the aspiration pump 10.
  • the pressure signal can preferably be determined by means of a pressure sensor.
  • the flow Pump 4 can preferably deliver a maximum of 150 ml / s, more preferably it can deliver a maximum of 120 ml / s.
  • FIG. 2 shows the relevant signal curves in a phacoemulsification system according to the prior art and in the phacoemulsification system according to the invention.
  • a profile of a volume flow (ASP) in the aspiration line is shown.
  • the volumetric flow in the aspiration line 9 increases, see reference numeral 21, until a constant value is reached in accordance with the suction power of the aspiration pump, see reference numeral 22. If occlusion occurs, see diagram 40 and there reference numeral 41 , the volume flow in the aspiration line decreases very rapidly to the value zero, see reference numeral 23.
  • Diagram 30 shows the associated course of the pressure p (ASP) in the aspiration line, with the beginning of the pumping the suction pressure negative pressure) rises to a certain value, see reference numeral 31, which remains constant during the pumping down, if the needle 6 of the phaco handpiece 5 not is clogged.
  • reference numeral 41 the aspiration pump 10 sucks the aspiration line 9 empty until a relatively high negative pressure 33 exists in the aspiration line 9.
  • this behavior of the volume flow and the pressure in the aspiration line sets an intraocular pressure p (IOP1), as shown in diagram 50.
  • IOP1 intraocular pressure
  • FIG. 51 Before surgery has the eye a normal intraocular pressure, see reference numeral 51. With the beginning of aspiration by the aspiration pump decreases despite inflow of irrigation fluid into the eye chamber, the intraocular pressure to a lower amount, see reference numeral 52, and initially remains constant. With the onset of occlusion, see reference numeral 41, fluid can no longer be aspirated through the needle 6 and the aspiration line 9 so that the intraocular pressure p (IOPl) rises again to the previous value, see reference numeral 53.
  • the diagram 60 shows the curve of the rotational speed n (PP) of the flow pump 4 as a function of the time t.
  • the decrease in the intraocular pressure according to reference numeral 52 is counteracted, so that the intraocular pressure p (IOP2 With the onset of an occlusion, the volume flow in the aspiration line decreases rapidly, see reference numeral 23, wherein the S flow pump 4 is driven so that their speed drops to zero, see reference numeral 63. If the occlusion breaks up and a strong suction in the eye occurs due to the high negative pressure in the aspiration, immediately the flow pump is driven to a higher speed, see reference numeral 64 to compensate for the fluctuation of the intraocular pressure, see reference numeral 54. That then the intraocular pressure no longer fluctuates, is from Dia- gram 90 can be seen.
  • FIG. 3 shows a diagram 100 with a change of the intraocular pressure p (IOP2) as a function of the rotational speed of the flow pump 4 in the phacoemulsification system according to the invention, when there is a hydrostatic pressure of 29 mmHg due to the fixed height of the irrigation fluid container.
  • IOP2 intraocular pressure p
  • FIG. 4 shows a profile of the rotational speed n (PP) of the flow pump 4 as a function of time. It can be seen that the control of the flow pump 4 is carried out with a rectangular signal which is applied at a frequency of 10 hertz (period 0.1 seconds). From Fig. 5, the associated pressure curve p (PP) of the flow pump can be seen. At constant speed, the flow pump can generate an overpressure of up to 0.5 bar (5 ⁇ 10 4 N / m 2 ), preferably of up to 0.3 bar (3 ⁇ 10 4 N / m 2 ). The smaller the frequency, the longer the flow pump 4 per period without interruption in operation. By a pulse width modulation of the control and variation of the frequency, the supplied amount of Irrigationsfluid can be varied at the same speed.

Abstract

L'invention concerne un système de phacoémulsification comprenant : un récipient de fluide d'irrigation pour le recueil du fluide d'irrigation, une conduite d'irrigation à travers laquelle peut couler le fluide d'irrigation, une pompe de circulation grâce à laquelle peut circuler le fluide d'irrigation, une conduite d'aspiration à travers laquelle peut s'écouler le fluide d'aspiration, une pompe d'aspiration pour aspirer le fluide d'aspiration, un dispositif pour la détection d'un signal de pression sur la base d'une pression régnant dans la conduite d'aspiration ou un dispositif pour la détection d'un signal de débit sur la base d'un débit dans la conduite d'aspiration, et un dispositif de commande qui est aménagé pour recueillir le signal de pression ou le signal de débit et pour commander la pompe de circulation sur la base du signal de pression ou du signal de débit de manière à produire une variation de pression ou de débit dans la conduite d'irrigation, le dispositif de commande étant conçu pour régler la vitesse de rotation de la pompe de circulation à une fréquence située dans la plage de 0 à 10 Hertz, la pompe de circulation générant une surpression dynamique pouvant aller jusqu'à 0,5 bar.
PCT/EP2016/055500 2015-03-21 2016-03-15 Système de phacoémulsification WO2016150754A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015003799.4 2015-03-21
DE102015003799.4A DE102015003799B4 (de) 2015-03-21 2015-03-21 Phakoemulsifikationssystem

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WO2016150754A1 true WO2016150754A1 (fr) 2016-09-29

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019069189A1 (fr) * 2017-10-04 2019-04-11 Johnson & Johnson Surgical Vision, Inc. Système et procédé pour augmenter la pression d'irrigation et pour maintenir la pio lors d'un afflux post-occlusion
US11071816B2 (en) 2017-10-04 2021-07-27 Johnson & Johnson Surgical Vision, Inc. System, apparatus and method for monitoring anterior chamber intraoperative intraocular pressure
CN114615959A (zh) * 2019-10-29 2022-06-10 卡尔蔡司医疗技术股份公司 眼科手术器械
US11446424B2 (en) 2017-10-04 2022-09-20 Johnson & Johnson Surgical Vision, Inc. Systems and methods for measuring fluid flow in a venturi based system
US20220409800A1 (en) * 2021-06-24 2022-12-29 Johnson & Johnson Surgical Vision, Inc. Accurate irrigation rate measurment system and method
WO2024081231A1 (fr) * 2022-10-11 2024-04-18 Bausch + Lomb Ireland Limited Détection d'occlusion dans des systèmes chirurgicaux ophtalmiques basés sur le vide
US11969380B2 (en) 2017-10-04 2024-04-30 Johnson & Johnson Surgical Vision, Inc. Advanced occlusion management methods for a phacoemulsification system

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102017213007A1 (de) * 2017-07-27 2019-01-31 Geuder Ag Vorrichtung zur Steuerung eines ophthalmologischen Systems sowie ein ophthalmologisches System
DE102017215677B3 (de) * 2017-09-06 2018-11-08 Geuder Aktiengesellschaft Ophthalmologisches System
DE102021210483B3 (de) * 2021-09-21 2022-09-15 Carl Zeiss Meditec Ag Ophthalmochirurgische Einrichtung

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020019607A1 (en) 1998-05-21 2002-02-14 Hai Bui Constant ocular pressure active infusion system
US20130072853A1 (en) * 2011-09-19 2013-03-21 Abbott Medical Optics Inc. Systems and methods for controlling vacuum within phacoemulsification systems
US20140114236A1 (en) * 2012-10-22 2014-04-24 Alcon Research, Ltd. Pressure Control in Phacoemulsification System
US20140323953A1 (en) * 2013-04-26 2014-10-30 Alcon Research, Ltd. Partial Venting System for Occlusion Surge Mitigation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020019607A1 (en) 1998-05-21 2002-02-14 Hai Bui Constant ocular pressure active infusion system
US20130072853A1 (en) * 2011-09-19 2013-03-21 Abbott Medical Optics Inc. Systems and methods for controlling vacuum within phacoemulsification systems
US20140114236A1 (en) * 2012-10-22 2014-04-24 Alcon Research, Ltd. Pressure Control in Phacoemulsification System
US20140323953A1 (en) * 2013-04-26 2014-10-30 Alcon Research, Ltd. Partial Venting System for Occlusion Surge Mitigation

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019069189A1 (fr) * 2017-10-04 2019-04-11 Johnson & Johnson Surgical Vision, Inc. Système et procédé pour augmenter la pression d'irrigation et pour maintenir la pio lors d'un afflux post-occlusion
US11071816B2 (en) 2017-10-04 2021-07-27 Johnson & Johnson Surgical Vision, Inc. System, apparatus and method for monitoring anterior chamber intraoperative intraocular pressure
US11383020B2 (en) 2017-10-04 2022-07-12 Johnson & Johnson Surgical Vision, Inc. System and method to augment irrigation pressure and to maintain IOP during post occlusion surge
US11446424B2 (en) 2017-10-04 2022-09-20 Johnson & Johnson Surgical Vision, Inc. Systems and methods for measuring fluid flow in a venturi based system
US11969380B2 (en) 2017-10-04 2024-04-30 Johnson & Johnson Surgical Vision, Inc. Advanced occlusion management methods for a phacoemulsification system
CN114615959A (zh) * 2019-10-29 2022-06-10 卡尔蔡司医疗技术股份公司 眼科手术器械
US20220409800A1 (en) * 2021-06-24 2022-12-29 Johnson & Johnson Surgical Vision, Inc. Accurate irrigation rate measurment system and method
US11806465B2 (en) * 2021-06-24 2023-11-07 Johnson & Johnson Surgical Vision, Inc. Accurate irrigation rate measurement system and method
WO2024081231A1 (fr) * 2022-10-11 2024-04-18 Bausch + Lomb Ireland Limited Détection d'occlusion dans des systèmes chirurgicaux ophtalmiques basés sur le vide

Also Published As

Publication number Publication date
DE102015003799A1 (de) 2016-09-22
DE102015003799B4 (de) 2016-12-08

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