WO2024027903A1 - Tubulure d'irrigation-aspiration multifonction pour dispositifs de chirurgie oculaire - Google Patents

Tubulure d'irrigation-aspiration multifonction pour dispositifs de chirurgie oculaire Download PDF

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Publication number
WO2024027903A1
WO2024027903A1 PCT/EP2022/071645 EP2022071645W WO2024027903A1 WO 2024027903 A1 WO2024027903 A1 WO 2024027903A1 EP 2022071645 W EP2022071645 W EP 2022071645W WO 2024027903 A1 WO2024027903 A1 WO 2024027903A1
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WO
WIPO (PCT)
Prior art keywords
tubing
ridge
aspiration
tube
surgical handpiece
Prior art date
Application number
PCT/EP2022/071645
Other languages
English (en)
Inventor
James Perkins
Original Assignee
Bausch + Lomb Ireland Limited
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 Bausch + Lomb Ireland Limited filed Critical Bausch + Lomb Ireland Limited
Priority to PCT/EP2022/071645 priority Critical patent/WO2024027903A1/fr
Publication of WO2024027903A1 publication Critical patent/WO2024027903A1/fr

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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
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • 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
    • A61F9/00745—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic

Definitions

  • the present disclosure relates to multi-function irrigation-aspiration tubing for ocular surgery devices.
  • a cataract clouds the natural lens of the eye, which includes mostly water and protein. Over time, these proteins may clump together to obscure the lens. This is generally corrected by removing the cataract lens and replacing it with a clear lens implant, such as through phacoemulsification eye surgery.
  • Phacoemulsification is a surgery technique on an eye where the internal lens is emulsified with a phacoemulsification (e.g., phaco) needle tip, which is driven to vibrate ultrasonically by an ultrasonic mechanism in the phaco surgical handpiece.
  • the ultrasonic vibration of the phaco needle creates a significant temperature rise of the needle, which can occur essentially instantaneously.
  • the emulsified lens material (which is mostly fluid) is aspirated from the eye through the phaco needle and replaced with an irrigation fluid (e.g., a balanced salt solution (BSS), etc.).
  • an irrigation fluid e.g., a balanced salt solution (BSS), etc.
  • Intraocular pressure is maintained in the eye while the phaco needle is aspirating ocular material from the eye by continuously infusing saline solution into the eye.
  • the constant replenishment of fluids in the eye is important to avoid collapse of the anterior chamber of the eye.
  • the irrigation fluid also cools the heating effects of the vibrating phaco needle, thus preventing burning of eye tissue at the incision site. Occasionally, large chunks of ocular material clog the phaco needle, which interrupts the aspiration flow and in turn causes interruption in the irrigation flow.
  • a device for ocular surgery includes a surgical handpiece including a power cord and an aspiration needle for removing ocular material from an eye, and co-extruded tubing.
  • the tubing includes an aspiration tube for receiving the ocular material removed from the eye by the surgical handpiece, an irrigation tube integrally formed with the aspiration tube for supplying irrigation fluid to the surgical handpiece, and a ridge defined along at least a majority of a length of the co-extruded tubing, the ridge defining a groove for receiving the power cord of the surgical handpiece.
  • tubing for an ocular surgical handpiece includes an aspiration tube for receiving ocular material removed from the eye by the surgical handpiece, and an irrigation tube integrally formed with the aspiration tube for supplying irrigation fluid to the surgical handpiece.
  • a first ridge is defined along at least a majority of a length of the tubing, and the ridge defines a groove for receiving a power cord of the surgical handpiece.
  • a second ridge is defined along at least a majority of the length of the co-extruded tubing.
  • FIG. 1 is a block diagram of a device for ocular surgery, according to the prior art.
  • Fig. 2 is a sectional view of tubing of the ocular surgery device of Fig. 1 , taken at A-A’.
  • Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
  • Spatially relative terms such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the coextruded tubing may connect a surgical handpiece to a console to control fluid flow to and from the surgical handpiece.
  • the tubing may have any suitable length for performing ocular surgery with the handpiece, and may be up to six feet in length in some cases.
  • the co-extruded tubing may include two tubes separated by a wall, to separately allow fluid flow to and from the surgical handpiece.
  • an irrigation tube may deliver irrigation fluid from a source of balanced salt solution (BSS) to a surgical handpiece and to the eye during surgery.
  • BSS balanced salt solution
  • the delivery of BSS maintains the intra-ocular pressure (IOP) of the eye as tissue and fluid is aspirated from the eye through the surgical handpiece.
  • IOP intra-ocular pressure
  • the other tube is an aspiration tube that connects the surgical handpiece to an aspiration reservoir (e.g., a bag, cassette, etc.) in the console that also houses the aspiration pump source.
  • an aspiration reservoir e.g., a bag, cassette, etc.
  • the aspiration tubing is as non-compliant (e.g., not flexible, resists dilation, resists collapse, etc.) as possible.
  • the irrigation tube may be very compliant and easily expandable so that when a vacuum surge occurs (e.g., typically after a piece of cataract tissue occluding a phacoemulsification needle tip has cleared), there is sufficient irrigation fluid supply to prevent eye chamber collapse, which would be very harmful to the patient.
  • a vacuum surge occurs (e.g., typically after a piece of cataract tissue occluding a phacoemulsification needle tip has cleared)
  • other suitable approaches for dealing with postocclusion surge may be incorporated in the system.
  • the co-extruded tubing may include a center ridge that runs at least a majority of the length of the tubing, and a groove for receiving a power cord for the phacoemulsification handpiece, a fragmentation handpiece, etc. This aids in cord management and may prevent or greatly reduce kinks in the tubes.
  • Some prior art techniques teach embedding wire in one or both tube walls, using cladding, or making the aspiration tube wall thicker than the irrigation tube wall to provide anti-kink benefits.
  • including external ridge(s) along the co-extruded tubing e.g., ribs on an external surface of the tubing, etc.
  • At least one of the external ridges may be configured to allow the electrical cable for the surgical handpiece to be inserted in a groove of the external ridge, therefore reducing the number of lines running through the operating area. This reduces the number of lines that need to be managed by the operating room staff during the surgery.
  • the surgical handpiece ergonomics and reliability are improved because the aspiration and irrigation lines may act as a strain relief. This may also reduce issues at the interface of the handpiece and cable.
  • the co-extruded tubing may be manufactured by producing both the irrigation tube and the aspiration tube from the same material at the same time.
  • Each of the aspiration and irrigation tubes may have a standard circular shape with a uniform wall thickness, although in other embodiments different opening shapes may be used, different wall thicknesses may be used, etc.
  • the tubing As the tubing is packaged, or during surgery if the user is not careful, the tubing can be pulled or placed in a position that may cause the tubing to be pinched or kinked, thus causing a reduction in fluid flow.
  • the reduction in irrigation flow can be detrimental and cause complications (e.g., chamber shallowing, a broken capsule, etc.), during the surgery.
  • Example embodiments described herein may reduce the likelihood of pinched or kinked tubing and resulting complications, via the one or more external ridges located on an exterior of the co-extruded tubing.
  • a device for ocular surgery is illustrated in Fig. 1 and indicated generally by reference number 100.
  • the ocular surgery device 100 includes a surgical handpiece 110 including a power cord 114 and an aspiration needle 112 for removing ocular material from an eye.
  • the device 100 also includes co-extruded tubing 102.
  • the tubing 102 includes an aspiration tube 106 for receiving the ocular material removed from the eye by the surgical handpiece 110, and an irrigation tube 104 integrally formed with the aspiration tube 106 for supplying irrigation fluid to the surgical handpiece 110.
  • a ridge is defined along at least a majority of a length of the co-extruded tubing 102.
  • the ridge defines a groove 108 for receiving the power cord 114 of the surgical handpiece 110.
  • Short tubing sections 101 , 103, 105, and 107 may be provided to facilitate connection of the tubing to the handpiece 110 and the console
  • the device 100 optionally includes a console 122 including a source of balanced salt solution (BSS) 120.
  • the irrigation tube 104 is adapted to supply the irrigation fluid from the source of BSS 120 to the surgical handpiece 110 during the ocular surgery, to maintain an inter-ocular pressure of the eye as the ocular material is aspirated from the eye through the surgical handpiece 110.
  • the irrigation tube 104 may include a compliant material adapted to expand in response to a vacuum surge to supply sufficient irrigation fluid to inhibit eye chamber collapse.
  • Fig. 1 illustrates a BSS source 120 located in the console 122, other embodiments may use other suitable irrigation fluids, may use irrigation sources from locations other than the console 122, etc.
  • the console 122 also includes an aspiration reservoir 116.
  • the aspiration tube 106 is connected between the surgical handpiece 110 and the aspiration reservoir 116 (e.g., to supply fluid that has been aspirated from the eye from the surgical handpiece 110 to the aspiration reservoir).
  • the aspiration tube 106 may include a non-compliant material adapted to inhibit flexion, dilation and collapse of the aspiration tube 106 during the ocular surgery.
  • the aspiration reservoir 116 may include any suitable bag, cassette, etc. for receiving the fluid.
  • An aspiration pump 118 is also housed in the console 122, and may be used to generate a vacuum pressure for suctioning fluid through the aspiration tube 106 from the surgical handpiece 110 to the aspiration reservoir 116.
  • Fig. 1 illustrates the aspiration reservoir 1 16 and the aspiration pump 118 located in the console 122, other embodiments may have the aspiration reservoir 116 and the aspiration pump 118 housed in other locations.
  • the internal lens of the eye is emulsified with the phacoemulsification needle 112, which is driven to vibrate ultrasonically by an ultrasonic mechanism in the surgical handpiece 110.
  • the ultrasonic vibration of the needle 112 significantly increases the temperature of the needle 112.
  • the emulsified lens material is aspirated from the eye through the needle 112 and the aspiration tube 106 to the aspiration reservoir 116 in the console 122, and replaced with an irrigation fluid from the BSS source 120 via the irrigation tube 104.
  • Intraocular pressure is maintained in the eye while the needle 112 is aspirating ocular material from the eye by continuously infusing saline solution into the eye.
  • the constant replenishment of fluids in the eye is important to avoid collapse of the anterior chamber of the eye.
  • the irrigation fluid also cools the heating effects of the vibrating needle 112, thus preventing burning of eye tissue at the incision site. Occasionally, large chunks of ocular material clog the needle 112, which may interrupt the aspiration flow through the aspiration tube 106 and may cause an interruption in the irrigation flow through the irrigation tube 104.
  • a ridge 108 is located along at least a majority of the co-extruded tubing 102. As shown in Fig. 1 , the ridge 108 is disposed along an entire length of the co-extruded tubing 102. In other embodiments, the ridge 108 may be disposed along less than the entire length of the tubing 102, may be disposed along at least a majority (e.g., greaterthan half) of the length of the tubing 102, etc.
  • the tubing 102 may have any suitable length for allowing a surgeon to move the handpiece 110 as needed during ocular surgery (e.g., up to six feet, etc.).
  • Fig. 2 illustrates a cross-sectional view of the co-extruded tubing 102 of Fig. 1 , taken at A-A’.
  • the ridge 108 may be disposed along an external surface of the co-extruded tubing 102 to increase bend resistance of the co-extruded tubing 102.
  • the external surface location of the ridge 108 may inhibit kinking of the co-extruded tubing 102 along both vertical and horizontal axes of the co-extruded tubing 102.
  • the tubing 102 includes a second ridge 128 that is located on an external surface of the tubing 102 opposite the ridge 108.
  • the co-extruded tubing 102 may include multiple ridges that are each disposed along at least a majority of the length the tubing 102.
  • Fig. 2 illustrates two ridges 108 and 128 located on opposite sides of the tubing 102, other embodiments may include more or less ridges, ridges positioned at other locations, etc.
  • the groove 109 of the ridge 108 includes two resilient arms 124 and 126.
  • the resilient arms 124 and 126 are adapted to removably retain the power cord 114.
  • a user may insert the power cord 114 into the groove 109 by pressing the power cord 114 between the resilient arms 124 and 126, to hold the power cord 114 in place via a friction fit, a press fit, etc.
  • the resilient arms 124 and 126 facilitate easy removal or positioning of the power cord 114 to fit different surgical setups.
  • a diameter of the groove 109 may be about 0.095 inches.
  • Fig. 2 illustrates the groove 109, in other embodiments the groove may have other suitable shapes for removably retaining the power cord 114. Similarly, other embodiments may have more or less than two resilient arms, resilient arms having different structural shapes, etc.
  • the irrigation tube 104 and the aspiration tube 106 each define a circular opening, and have different wall thicknesses.
  • a diameter of the opening 107 of the aspiration tube 106 is 1/16 of an inch
  • a diameter of the opening 105 of the irrigation tube 104 is 5/32 of an inch.
  • the walls of the irrigation tube 104 and the walls of the aspiration tube 106 may include the same material.
  • the irrigation tube 104 and the aspiration tube may have other diameters, may have the same diameter as one another, may have the same wall thickness as one another, may have openings including shapes other than circular, etc.
  • tubing for an ocular surgical handpiece includes an aspiration tube for receiving ocular material removed from the eye by the surgical handpiece, and an irrigation tube integrally formed with the aspiration tube for supplying irrigation fluid to the surgical handpiece.
  • a first ridge is defined along at least a majority of a length of the tubing, with the ridge defining a groove for receiving a power cord of the surgical handpiece.
  • a second ridge is defined along at least a majority of the length of the co-extruded tubing.
  • the first ridge and the second ridge may be disposed along opposite external sides of the tubing to increase bend resistance of the tubing and to inhibit kinking of the tubing along both vertical and horizontal axes of the tubing.
  • the groove may include first and second resilient arms to removably retain the power cord of the ocular surgical handpiece.
  • the surgical handpeice 110, the console 122, and any control circuits for the components of the device 100 may include a microprocessor, microcontroller, integrated circuit, digital signal processor, etc., which may include memory.
  • the surgical handpeice 110, the console 122, and any control circuits may be configured to perform (e.g., operable to perform, etc.) any processes for controlling the device 100 using any suitable hardware and/or software implementation.
  • the surgical handpeice 110, the console 122, and any control circuits may execute computer-executable instructions stored in a memory, may include one or more logic gates, control circuitry, etc.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Anesthesiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)

Abstract

Un dispositif de chirurgie oculaire comprend une pièce à main chirurgicale comprenant un cordon d'alimentation et une aiguille d'aspiration pour retirer le matériau oculaire d'un œil, et un tube co-extrudé. Le tube comprend un tube d'aspiration pour recevoir le matériau oculaire retiré de l'œil par la pièce à main chirurgicale, un tube d'irrigation formé d'un seul tenant avec le tube d'aspiration pour fournir un fluide d'irrigation à la pièce à main chirurgicale, et une crête définie le long d'au moins une majorité d'une longueur du tube co-extrudé, la crête définissant une rainure pour recevoir le cordon d'alimentation de la pièce à main chirurgicale.
PCT/EP2022/071645 2022-08-02 2022-08-02 Tubulure d'irrigation-aspiration multifonction pour dispositifs de chirurgie oculaire WO2024027903A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2022/071645 WO2024027903A1 (fr) 2022-08-02 2022-08-02 Tubulure d'irrigation-aspiration multifonction pour dispositifs de chirurgie oculaire

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2022/071645 WO2024027903A1 (fr) 2022-08-02 2022-08-02 Tubulure d'irrigation-aspiration multifonction pour dispositifs de chirurgie oculaire

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WO2024027903A1 true WO2024027903A1 (fr) 2024-02-08

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994008638A2 (fr) * 1992-10-09 1994-04-28 Symbiosis Corporation Instrument endoscopique d'aspiration/irrigation
FR2740028A1 (fr) * 1995-10-20 1997-04-25 Garnier Bernard Dispositif de regulation d'aspiration, pour appareil de microchirurgie notamment de chirurgie oculaire
US20070149950A1 (en) * 2005-07-21 2007-06-28 Bausch & Lomb Incorporated Thin wall surgical irrigation tubing with longitudinal reinforcements
CN110898316A (zh) * 2019-12-19 2020-03-24 南华大学附属第一医院 用于骨髓腔的灌注与引流系统

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994008638A2 (fr) * 1992-10-09 1994-04-28 Symbiosis Corporation Instrument endoscopique d'aspiration/irrigation
FR2740028A1 (fr) * 1995-10-20 1997-04-25 Garnier Bernard Dispositif de regulation d'aspiration, pour appareil de microchirurgie notamment de chirurgie oculaire
US20070149950A1 (en) * 2005-07-21 2007-06-28 Bausch & Lomb Incorporated Thin wall surgical irrigation tubing with longitudinal reinforcements
CN110898316A (zh) * 2019-12-19 2020-03-24 南华大学附属第一医院 用于骨髓腔的灌注与引流系统

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