Classifications

• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/74—Suction control
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/72—Cassettes forming partially or totally the fluid circuit
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/77—Suction-irrigation systems
  • A61M1/772—Suction-irrigation systems operating alternately
• • 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
  • A61M3/00—Medical syringes, e.g. enemata; Irrigators
  • A61M3/02—Enemata; Irrigators
  • A61M3/0201—Cassettes therefor
• • 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
  • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/78—Means for preventing overflow or contamination of the pumping systems
• • 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
  • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
  • A61M2205/123—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs
• • 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
  • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
  • A61M2205/3382—Upper level detectors
• • 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
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/06—Head
  • A61M2210/0612—Eyes

Definitions

• the present invention relates generally to a system useful for various surgical procedures. More specifically, it relates to a surgical system having means for assisting air venting or pressure regulation in an ophthalmic surgical procedure.
• a cataract is an opacity that develops in the crystalline lens of the eye or in its envelope.
• One medical procedure to remove a cataract-affected lens is phacoemulsification (phaco) using ultrasonic sound to break up or emulsify the cataract.
• a phacoemulsification machine typically includes a handpiece with both irrigation and aspiration functions.
• a phaco handpiece aspirates in emulsified fluids and simultaneously replaces those aspirated fluids with balanced salt solution (BSS) to maintain a proper pressure of the anterior chamber of the patient's eye.
• BSS balanced salt solution
• Such a handpiece is connected to a pump generating negative pressure or vacuum to drive aspiration, by which debris from the eye flow through a tube to means for collection such as a cassette, a bag, or bottle.
• a common and potentially dangerous occurrence in ophthalmic surgery is "post- occlusion surge.”
• irrigation fluid is constantly infused into the surgical site and the fluid and emulsified tissue are aspirated away from the surgical site through the phaco handpiece.
• bits of tissue are larger than the aspiration lumen in the phaco handpiece, which can result in a clogged phaco needle.
• surge As long as the aspiration conduit remains clogged, a negative pressure builds up throughout the aspiration system. Then, after the clog has been removed, the system can experience what is commonly referred to as surge.
• Post-occlusion surge can cause serious damage to a patient's eye, such as by rupturing a capsular bag and allowing vitreous to leak from the eye's posterior into the eye's anterior chamber or cause irreparable damage to the cornea's endothelial cells.
• endothelial cells are not regenerated naturally and it is crucial to prevent post-occlusion surge in an ophthalmic operation.
• Air evacuating pumps such as a rotary vane pump and a venturi pump, are widely used as sources of vacuum for surgical aspiration.
• a rotary pump for example, spinning of the rotor is necessary to force fluid to move through a tube to a reservoir where the spinning of the rotor generates vacuum to drive aspiration.
• One way to reduce post-occlusion surge is to sense an occlusion at the tip of the handpiece or the conduit and direct the pump to stop so that vacuum is not generated any more.
• US 3,902,495 describes a control system containing a relief valve discharging undue pressure from the tube upon reaching a predetermined pressure.
• a surgical system comprising means for applying pressure to a venting valve to efficiently remove the undesirable effect of momentum-driven pumping after a stop signal.
• a surgical system for ophthalmic surgery comprising means applying pressure to a venting valve to efficiently remove the undesirable effect of momentum-driven pumping after a stop signal.
• an ophthalmic surgical system for cataract surgery comprising means for applying pressure to a venting valve to efficiently remove the undesirable effect of momentum-driven pumping after a stop signal.
• a surgical system comprising means for applying pressure to a venting valve and a controller to monitor the intra-conduit pressure of the system and send a stop signal to the means for applying pressure.
• a surgical system for ophthalmic surgery comprising means for applying pressure to a venting valve and a controller to monitor the intra-conduit pressure of the system and send a stop signal to the means for applying pressure.
• a surgical system comprising means for applying pressure to a venting valve, one or more additional pressure relief valves to ease the pressure and a controller to monitor the intra-conduit pressure of the system and send a stop signal to the means for applying pressure and the additional pressure relief valves.
• a system for ophthalmic surgery comprising means for applying pressure to a venting valve, one or more additional pressure relief valves to ease the pressure and a controller to monitor the intra-conduit pressure of the system and send a stop signal to the means for applying pressure and the additional relief valves.
• FIG. 1 is a diagrammatic view of one embodiment of a surgical system comprising means for applying pressure to a venting valve;
• FIG. 2 is a diagrammatic view of another embodiment of a surgical system comprising means for applying pressure to a venting valve, a controller and an optional pressure relief valve.
• the surgical system 10 comprises a source of irrigation fluid 20, a collection cassette 30, a vacuum pump 40, a surgical handpiece 50, conduits 60 and 62 connecting the surgical handpiece to each of the irrigation fluid source and the vacuum pump/the collection cassette, a venting valve 70 and means for applying pressure 80 to a valve 70.
• the surgical system 10 is particularly useful in ophthalmic surgery where it is necessary to break up and remove undesirable biological materials from the patient's eye. Specifically, the surgical system 10 can be used to remove cataract without causing irreparable damage to the eye.
• the source of irrigation fluid 20 typically includes a fluid container 22 and surgical fluid 24.
• the surgical fluid can be any known surgical fluid and an ordinary skilled person in the art can select proper surgical fluid in accordance with the nature of the surgery to be operated.
• the surgical fluid 24 is ophthalmic surgical fluid such as, for example, BSS.
• Each end of the conduit 60 is connected to the container 20 and the phaco handpiece 50 respectively so that the ophthalmic surgical fluid is delivered to the patient's eye through the irrigation sleeve 54 of the phaco handpiece 50.
• the collection cassette 30 typically has a collection chamber and an inlet and an outlet for connection to each of the handpiece 50 and the vacuum pump 40.
• the collection chamber accommodates biological debris aspirated from the surgical site via the phaco needle 52 of the handpiece 50 and the aspiration conduit 62.
• the collection cassette 30 can be selected from any collection means for a surgical system known in the art, regardless of its reusability.
• the cassette 30 can be any known reusable or disposable collection means.
• the collection cassette 30 is installed in operative association with the handpiece 50 and the pump 40 by any means known in the art.
• the vacuum pump 40 is connected to the collection cassette 30 and the handpiece 40 through the aspiration conduit 62 to provide the aspiration system comprising the handpiece, the conduit and the collection cassette with negative pressure or vacuum.
• the vacuum pump 40 can be any pump known in the art as long as it is suitable for a surgical system including the present surgical system.
• the vacuum pump 40 is one suitable for an ophthalmic surgical system.
• Examples of a pump applicable to the present invention are, but not limited to, a venturi pump, a rotary vane pump, a diaphragm pump, a liquid ring pump, a piston pump, a scroll pump, a screw pump, Wankel pump, an external vane pump, a booster pump, a multistage roots pump, a peristaltic pump, and a Toepler pump.
• the pump is selected from a venturi pump, a rotary vane pump and diaphragm pump.
• the surgical handpiece 50 can be a conventional phacoemulsification handpiece comprising a phaco needle 52 and an annular sleeve for irrigation 54 surrounding the needle.
• the surgical handpiece is placed on or into the surgical site to remove undesirable biological materials.
• the phaco handpiece 50 is inserted though an incision in an eye and the phaco needle coupled to an energy source applies energy, such as ultra-sound and laser, to the surgical site to break up undesirable biological materials such as cataract.
• the surgical fluid 24 is infused into the surgical site through the annular sleeve 54 and the phaco needle 52 simultaneously aspirates fluids containing the undesirable materials away from the eye.
• the surgical system 10 typically requires two separate conduits 60 and 62 for the irrigation and aspiration system.
• the irrigation conduit 60 connects the surgical handpiece 50 to the irrigation fluid source 20 to provide the surgical site with the surgical fluid 24, such as BSS.
• the irrigation system may contain one or more valves placeable between the handpiece 50 and the irrigation fluid source 20 to control the irrigation flow rate, thereby helping maintenance of a proper pressure of the surgical site.
• the aspiration conduit 62 connects, for example, the surgical handpiece 50 to the collection cassette 30 and then to the vacuum pump 40, but it is obvious to an ordinary skilled person in the art that it is possible to modify the placement and the connection of the aspiration components.
• the vacuum pump 40 is operatively connected to the collection cassette 30 through the aspiration conduit 62 such that undesirable biological materials from the surgical site are aspirated to the collection cassette 30 for temporary storage and later disposal.
• the venting valve 70 allows an air inflow into the aspiration conduit 62 to equalize the intra-conduit negative pressure.
• the venting valve 70 can be any valve known in the art suitable for controlling the intra-conduit pressure but which should be configured to be connectable to the means for applying pressure 80 to achieve the object of the present invention. It is obvious to an ordinary skilled person in the art that the venting valve 70 can be one or more and placeable anywhere in the aspiration system.
• the means for applying pressure to the venting valve 80 is connected to the valve 70 such that the pressure generated by the pressurizing means 80 forces atmospheric air into the valve 70.
• the means for applying pressure 80 infuses positive pressure into the valve 80 to equalize the negative pressure built up inside the aspiration conduit 62.
• the pressurizing means 80 can be installed anywhere on the aspiration conduit 62.
• the pressurizing means 80 is designed to generate and apply positive pressure to the valve 70 immediately upon receiving a stop signal, resulting in accelerated venting.
• the means for applying pressure 80 can be a pump known in the art. There is no limitation in selecting a pump suitable for the present invention as long as it can produce positive pressure and be connectable to a venting valve.
• the pressurizing means 80 is a pump suitable for a surgical system including the present surgical system. More preferably, the pressurizing means 80 is a pump tailored to an ophthalmic surgical system.
• the surgical system 12 comprises, in addition to the components illustrated in FIG. 1, a controller 90 which is connected to the means for applying pressure to the venting valve 80.
• the controller 90 is designed to send a stop signal to the means for applying pressure to the venting valve 80 when receiving a manual signal from an operator such as a surgeon or sensing a pre-determined level of pressure difference that can lead to post-occlusion surge.
• the controller 90 may contain means for monitoring the pressure of the aspiration conduit 62 and means for sending a mechanical or electronic signal to the means for applying pressure to the venting valve 80. Therefore, in one embodiment, the controller 90 contains a pressure transducer capable of measuring the vacuum level of the aspiration conduit 62 and generating a signal to the means 80.
• the controller 90 can be computerized by electronic means to optimally control the surgical system based on various parameters where the electronic means determines the best timing for triggering the components to stop the aspiration system.
• the surgical system 12 may have more than one pressurizing means 80a and 80b coupled to each of one or more venting valves to increase their efficiency of pressure equalization.
• one pressurizing means 80a is installed between the cassette 30 and the handpiece 50, and the other 80b is between the pump 40 and the cassette 30 where each pressurized venting system removes negative pressure build-up within the aspiration conduit 62.
• the controller 90 may be linked to each of the pressurizing means to control the pressure equalization processes simultaneously.
• the surgical system 12 optionally comprises a pressure relief valve 100 connected to the aspiration conduit 62 to prevent post-occlusion surge in the surgical site such as the eye chamber.
• the pressure relief valve 100 can be a vacuum level control valve allowing an air flow into the aspiration conduit 62 at a pre-determined pressure.
• the surgical system 10 may have one or more pressure relief valves 90 to maximize the efficiency of preventing post-occlusion surge.
• the controller 80 is linked to each of the pressurizing means 80 and the pressure relief valve 100 so that the controller 90 controls both components simultaneously. A stop signal generated by the controller 90 directs these components to work in unison to prevent post-occlusion surge. In such a system, one signal results in prompt equalization of the negative pressure within the aspiration system.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Engineering & Computer Science (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Vascular Medicine (AREA)
• Pulmonology (AREA)
• External Artificial Organs (AREA)
• Surgical Instruments (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Publications (1)

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• 2007
  • 2007-12-20 US US11/961,293 patent/US8246579B2/en not_active Expired - Fee Related
• 2008
  • 2008-12-18 ES ES08866755T patent/ES2393044T3/es active Active
  • 2008-12-18 KR KR1020107013469A patent/KR20100099187A/ko not_active Withdrawn
  • 2008-12-18 CA CA2709845A patent/CA2709845C/en not_active Expired - Fee Related
  • 2008-12-18 WO PCT/US2008/087392 patent/WO2009085932A1/en not_active Ceased
  • 2008-12-18 EP EP08866755A patent/EP2227264B1/en not_active Not-in-force
  • 2008-12-18 JP JP2010539789A patent/JP5406853B2/ja not_active Expired - Fee Related
  • 2008-12-18 CN CN2008801215342A patent/CN101932348B/zh not_active Expired - Fee Related

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