Classifications

• • 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
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00821—Methods or devices for eye surgery using laser for coagulation
• • 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
  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
• • 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
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
  • A61F2009/0087—Lens

Definitions

• the present invention relates to ophthalmic surgical equipment and more particularly to posterior segment ophthalmic surgical equipment. Even more particularly, the present invention relates to multi-fiber ophthalmic probes.
• Microsurgical instruments typically are used by surgeons for removal of tissue from delicate and restricted spaces in the human body, particularly in surgery on the eye, and more particularly in procedures for removal of the vitreous body, blood, scar tissue, or the crystalline lens.
• Such instruments include a control console and a surgical handpiece with which the surgeon dissects and removes the tissue.
• the handpiece may be a vitreous cutter probe, a laser probe, an illumination probe, or an ultrasonic fragmenter for cutting or fragmenting the tissue and is connected to the control console by a long air- pressure (pneumatic) line and/or power cable, optical cable, or flexible tubes for supplying an infusion fluid to the surgical site and for withdrawing or aspirating fluid and cut/fragmented tissue from the site.
• the cutting, infusion, and aspiration functions of the handpiece are controlled by the remote control console that not only provides power for the surgical handpiece(s) (e.g., a reciprocating or rotating cutting blade or an ultrasonically vibrated needle), but also controls the flow of infusion fluid and provides a source of vacuum (relative to atmosphere) for the aspiration of fluid and cut/fragmented tissue.
• the functions of the console are controlled manually by the surgeon, usually by means of a foot-operated switch or proportional control.
• hubbed cannulae were developed at least by the mid-1980s. These devices consist of a narrow tube with an attached hub. The tube is inserted into an incision in the eye up to the hub, which acts as a stop, preventing the tube from entering the eye completely. Surgical instruments can be inserted into the eye through the tube, and the tube protects the incision sidewall from repeated contact by the instruments. In addition, the surgeon can use the instrument, by manipulating the instrument when the instrument is inserted into the eye through the tube, to help position the eye during surgery.
• the distal tip contain a non-bent straight portion for ease of insertion of the bent portion, which must flexibly straighten as it passes through the hubbed cannula.
• the straight portion of the distal tip allows the bent portion to flexibly pass through the hubbed cannula before the distal cannula of the handpiece enters the hubbed cannula, to allow maximum bending clearance of the flexible portion, thereby minimizing the bending strain and corresponding frictional insertion forces.
• Such a large bend radius, large diameter flexible tube, and straight distal tip cause the useable portion of the fiber to extend a relatively long distance from the distal tip of the probe and limits laser treatment access of the probe.
• a further disadvantage in the known art is the flexibility of the distal cannula, which is a function of the material properties and cross sectional moment of inertia, as determined by the gauge size of the outside diameter of the cannula to fit within the hubbed cannula, and the inside diameter of the cannula to accept the flexible tube.
• the outer and inner diameters of the cannula determine the flexibility of the cannula. This flexibility limits the surgeon's ability to use the instrument to manipulate the position of the eye during surgery.
• a further disadvantage in the known art is that it does not offer a nonarticulating flexible-tip probe providing both laser and illumination delivery through separate paths optimized for each delivery function.
• a need continues to exist for a non-articulating flexible-tip probe that does not require a straight portion of flexible tube at the distal tip, and which thus provides a more compact useable tip length, thereby allowing greater laser treatment access to internal posterior structures of the eye without compromising insertion forces.
• the need also continues to exist for a flexible-tip probe which provides increased rigidity of the distal cannula to facilitate manipulation of the eye position during surgery.
• the need exists for a flexible-tip probe which provides both laser and illumination delivery through separate paths optimized for each delivery function.
• the present invention improves upon prior art by providing a probe having a flexible, small diameter fiber within a flexible tube, comprising the non-articulating distal tip of the probe.
• the small diameter fiber and tube combination allow the fiber to be bent in a tight radius comprising the major portion of the length of the exposed portion of the fiber, minimizing the need for a straight portion to reduce insertion forces.
• Such a tight radius and compact length allow the fiber greater access to the internal posterior structures of the eye; thus increasing the laser treatment area of the probe, without compromising insertion forces.
• an objective of the present invention is to provide a laser probe having a flexible, small diameter non-articulating fiber/tube comprising the distal tip of the probe.
• Another objective of the present invention is to provide a laser probe having a flexible, small diameter fiber/tube comprising the distal tip of the probe that is bent in a tight radius comprising the major portion of the length of the exposed portion of the fiber.
• a further objective of the present invention is to provide a laser probe that allows greater access to the internal posterior structures of the eye.
• a further objective of the present invention is to provide increased rigidity of the distal cannula to facilitate manipulation of the eye position during surgery.
• a further objective of the present invention is to provide a flexible-tip laser probe able to deliver both laser and illumination through separate, optimized fiber optic paths.
• FIG. 1 is a perspective view of the probe of the present invention.
• FIG. 2 is an elevational view of the probe of the present invention.
• FIG. 3 is a cross-sectional view of the probe of the present invention.
• FIG. 4 is a cross-sectional view of an alternate embodiment of the present invention, having separate laser and illumination fiber optic delivery paths.
• FIG. 5 is a cross-sectional magnified view of distal end of an embodiment of the present invention shown in FIG. 4.
• Embodiments of the probe of the present invention provide for a flexible illuminated laser probe with separate, optimized fibers for laser and illumination in a single instrument designed for minimally invasive Trocar- entry surgical systems, unlike the prior art which does not provide for separate fibers to deliver laser and illumination light and that can be used in minimally invasive Trocar-entry surgical systems.
• the embodiments of this invention thus can provide a probe having optimal illumination intensity, ease of insertion to a surgical site, and a compact tip for broad treatment access.
• Some of the advantages that can be provided by the embodiments of this invention are: minimally invasive retinal photo-coagulation with directed, optimized illumination of a treatment area; laser and illumination in a single instrument, allowing a surgeon to perform self-scleral depression; compact curved tip and short active length provide broad access to peripheral retina; reduces or eliminates the possibility of elliptical burn associated with straight tipped laser probes; help to avoid lens contact when treating a surgical site opposite to entry port; and facilitate treatment posterior to the sclera buckle.
• probe 10 of the present invention generally consists of handle or body 12, containing or encasing a laser fiber optic 16 and/or an illumination fiber optic 22, flexible tube 21 , distal cannula 18, and fiber optic sheath 14.
• Body 12 is generally hollow and can be made from any suitable material such as stainless steel, titanium or thermoplastic.
• Cannula 18 may be made from any suitable material such as titanium or stainless steel and held within body 12 by any conventional method, such as adhesive or crimping.
• Fiber optic sheath 14 may be any suitable tubing such as thermoplastic or silicone.
• the probe can comprise a plurality of fiber optic cables, each having one or more optical fibers (e.g., fiber optics such as laser fiber optic 16 and illumination fiber optic 22).
• the plurality of fiber optic cables and fiber optics can have the same or similar optical properties or can each have unique optical properties suitable for their purpose (e.g., illumination or laser light).
• Laser fiber optic 16 and illumination fiber optic 22 can be connected on a proximal end (not shown) to any suitable laser or illumination source through a connector of a type well-known in the art and are surrounded by flexible tube 21 with exposed portion 19.
• Flexible tube 21 is made from a shape memory alloy such as Nitinol, and is held within cannula 18 by any conventional method, such as adhesive or crimping, and encases laser fiber optic 16 and/or illumination fiber optic 22, which are held to inner diameter of flexible tube 21 by any conventional method such as adhesive or crimping.
• Laser fiber optic 16, illumination fiber optic 22, and exposed portion 19 of flexible tube 21 extend beyond distal end 20 of cannula 18 a distance of approximately 3 millimeters to 14 millimeters, with approximately 4 millimeters to 6 millimeters or 1 1 millimeters to 13 millimeters being most preferred, respectively for a single fiber optic or a plurality of fiber optics encased in the flexible tube 21.
• Laser fiber optic 16 and illumination fiber optic 22 may be made of any fiber optic material suitable for conducting laser or illumination light, respectively.
• Preferable for a single laser delivery fiber optic is silica (or glass) with an outer diameter of between 100 ⁇ and 125pm with at least exposed portion 19 of flexible tube 21 being a 33 gauge (approximately 0.008 inches OD) flexible nitinol tube bent at an angle of approximately 30-45° on a radius of approximately between 4.5 millimeters and 6 millimeters along exposed section 19.
• the section of laser fiber optic 16 within exposed section 19 can be curved or bent beginning at or near distal end 20 of cannula 18, with minimal or no straight section near distal end 20 of cannula 18.
• Such a construction improves peripheral laser treatment access near the point of entry of cannula 18.
• the simultaneous insertion force of the exposed section 19 with the cannula 18 into a hubbed surgical cannula remains within an optimal range to facilitate manual insertion and extraction.
• Preferable material for a laser fiber optic with additional illumination fiber optic, or for a plurality of fiber optics is silica or plastic or a combination thereof, with outer diameter between 100pm and 250pm with at least exposed portion 19 of flexible tube 21 being a 31 to 28 gauge (approximately 0.010 to 0.015 inches OD) flexible nitinol tube bent at an angle of approximately 30-45° on a radius of approximately between 7 millimeters and 15 millimeters along exposed portion 19.
• the section of laser fiber optic 16 and/or illumination fiber optic 22 within exposed section 19 can be curved or bent beginning at or near distal end 20 of cannula 18, with minimal or no straight section near distal end 20 of cannula 18.
• Such a construction provides both the laser and illumination functions, as well as improved peripheral laser treatment access near the point of entry of cannula 18.
• the insertion force of the exposed section 19 into a hubbed surgical cannula remains within an optimal range to facilitate manual insertion and extraction, while providing the additional illumination function.
• a further reduction of insertion force may be realized by the use of anti-friction coating 23 on the exposed section 19 of flexible tube 21.
• exposed section 19 encasing laser fiber optic 16 and/or illumination fiber optic 22 can be straightened so that exposed section 19 can be inserted into an eye through a 23 gauge or a 25 gauge hubbed cannula. Once in the eye, the shape memory characteristics of the nitinol tube cause exposed section 19 to resume its curved configuration.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Ophthalmology & Optometry (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Vascular Medicine (AREA)
• Optics & Photonics (AREA)
• Physics & Mathematics (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Pathology (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Laser Surgery Devices (AREA)
• Endoscopes (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (10)

Applications Claiming Priority (4)

Publications (1)

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Cited By (3)

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Citations (4)

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• 2010
  • 2010-12-15 KR KR1020127024294A patent/KR20130008556A/ko not_active Withdrawn
  • 2010-12-15 EP EP10846295.3A patent/EP2509526A4/en not_active Withdrawn
  • 2010-12-15 RU RU2012139445/14A patent/RU2012139445A/ru not_active Application Discontinuation
  • 2010-12-15 BR BR112012020778A patent/BR112012020778A2/pt not_active IP Right Cessation
  • 2010-12-15 JP JP2012553880A patent/JP2013519492A/ja active Pending
  • 2010-12-15 PH PH1/2012/501451A patent/PH12012501451A1/en unknown
  • 2010-12-15 CN CN2010800640953A patent/CN102762162A/zh active Pending
  • 2010-12-15 WO PCT/US2010/060538 patent/WO2011102870A1/en not_active Ceased
  • 2010-12-15 AU AU2010346509A patent/AU2010346509A1/en not_active Abandoned
  • 2010-12-15 MX MX2012009035A patent/MX2012009035A/es not_active Application Discontinuation
  • 2010-12-15 CA CA2787024A patent/CA2787024A1/en not_active Abandoned

Patent Citations (4)

Non-Patent Citations (1)

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