WO1999017821A1 - Device for administration of viscoelastic substance - Google Patents

Device for administration of viscoelastic substance Download PDF

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Publication number
WO1999017821A1
WO1999017821A1 PCT/US1998/021001 US9821001W WO9917821A1 WO 1999017821 A1 WO1999017821 A1 WO 1999017821A1 US 9821001 W US9821001 W US 9821001W WO 9917821 A1 WO9917821 A1 WO 9917821A1
Authority
WO
WIPO (PCT)
Prior art keywords
main body
body portion
needle
composition
viscoelastic substance
Prior art date
Application number
PCT/US1998/021001
Other languages
French (fr)
Inventor
David Haselkorn
Original Assignee
Bio-Technology General Corp.
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 Bio-Technology General Corp. filed Critical Bio-Technology General Corp.
Priority to AU96852/98A priority Critical patent/AU9685298A/en
Publication of WO1999017821A1 publication Critical patent/WO1999017821A1/en

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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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
    • 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
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

Definitions

  • This invention is directed toward a device for introducing a viscoelastic substance inlto the intraocular cavity of a patient .
  • Viscoelastic substances are well known for their use in intraocular surgery. These substances are compositions which are introduced into the eye during ocular (ophthalmic) surgery to maintain the ocular structure and protect the ocular tissue. The viscoelastic substance is introduced into the intraocular cavity by means of a syringe and needle (cannula) .
  • U.S. Patent No. 4,361,149 discloses an injection syringe in which the injectable substance is contained in an ampule sealed at the front end with a pierceable seal and at the other end with a plug serving as a piston.
  • the syringe body contains a piercing point which upon piercing the pierceable seal of the ampule permits the pharmacological substance to pass into the needle upon exertion of pressure upon the plunger.
  • the injection is carried out by first moving the needle so as to penetrate the reservoir containing the composition for injection, permitting the composition to enter the needle and hence to be injected into the patient.
  • syringes disclosed in the '473 and '871 patents are described for intravenous (IV) or intramuscular (IM) injection of e.g. drugs and vaccines. Neither of these patents teach or suggest viscoelastic substances, nor the use of these syringes for introducing a viscoelastic substance into the intraocular cavity of the eye of a patient in the course of ophthalmic surgery.
  • the device of this invention is for introduction of a viscous or viscoelastic substance into the intraocular cavity of a patient ' s eye .
  • the syringes of the '871 and '473 patents are intended for administration of compositions comprising non-viscous solutions.
  • the needle appropriate for use with a non-viscous substance is different from the needle appropriate for a viscous or viscoelastic substance.
  • a viscoelastic substance must be administered specifically with a narrow gauge needle which will exert the shear forces necessary to reduce the viscosity of the viscoelastic substance in order to permit injection.
  • a narrow gauge needle also facilitates delicate maneuvering within the eye, and reduces the risk of damage to the tissues and organelles of the eye.
  • the needles disclosed for use with the syringe of the '871 and '473 patents are hypodermic needles and have both ends pointed. One end is pointed to penetrate into the reservoir means containing the injectable composition, and the other end is pointed to penetrate the skin of the patient receiving the injection. Unlike the needle of the prior art syringe which is pointed at both ends, the needle component of the device of the present invention is not pointed but rounded at the end which is used to introduce the viscoelastic substance into the intraocular cavity to permit passage of the needle through an incision previously cut into the eye of the patient's eye.
  • Healon ® is a device comprised of a syringe containing a composition of hyaluronic acid contained in an ampule inside the syringe. Depressing the plunger of the syringe results in the seal of the ampule being punctured by a piercing point integral to the body of the syringe. Further pressure on the plunger results in the expulsion of the hyaluronic acid composition from the ampule into a needle (cannula) and from there into the intraocular cavity. The needle is supplied separately and must be assembled onto the syringe before use.
  • This additional step of assembly of the needle onto the syringe presents an additional complexity in the use of the device. Improper assembly of the needle could lead to disassembly during use with all the problems such an occurrence would cause such as violation of sterility, leakage of the viscoelastic from the syringe, etc. Furthermore, this form of needle has been known to allow the injection of air bubbles into the eye. Additionally, the costs of manufacturing this device are quite considerable due its complexity e.g. need for separate syringe, ampule, plunger, needle, etc. and the assembly and sterilization of this system. The attendant costs result in a high ultimate price of the end-product which poses a considerable burden on consumers of the product i.e. health services and patients.
  • BIOLON ® is a prefilled disposable glass syringe containing a viscoelastic composition of hyaluronic acid.
  • BIOLON ® is equipped with a special needle assembly. This needle assembly consists of two needle components of two different diameters soldered together, and contained inside a metal sleeve to which they also are soldered. The needle assembly was specially designed so that the needle, unlike ordinary needle assemblies, on assembly to the syringe is actually inserted into the body of the syringe. In addition, the needle end is bent to facilitate its use and manipulation by the surgeon.
  • the present invention provides a loaded single use device for introducing a viscoelastic substance into the intraocular cavity of a patient during ophthalmic surgery.
  • This invention also relates to the use of this device for introducing a viscoelastic substance into the intraocular cavity of a patient during ophthalmic surgery.
  • the invention comprises a loaded single-use disposable device for introducing a viscoelastic substance into the intraocular space of a patient which comprises:
  • a syringe such syringe comprising:
  • a neck portion coupled to the needle portion and to the main body portion for directing the viscoelastic substance from the main body portion to the needle portion;
  • the main body portion in response to partial compression of both of the end panels together, the main body portion partially collapses to expel some of the viscoelastic substance out of the main body portion; and wherein the main body portion substantially collapses in response to complete compression of both the end panels together to prevent the main body portion from being reformed and to expel the viscoelastic substance out of the main body portion.
  • Figure 1 is a diagram of the syringe portion of the device of the invention.
  • Figure 2A shows a detail of needle point 16 of Figure 1.
  • Figures 2B shows the corresponding needle point of the syringe disclosed in the '871 and '473 patents.
  • the clinical indications for the introduction of a viscoelastic substance into the intraocular cavity include, but are not limited to ophthalmic or ocular surgery for treatment of cataract comprising intracapsular and extracapsular lens extraction and lens insertion, phacoemulsification, glaucoma surgery, corneal surgery for accidental trauma, retinal detachment and vitreal replacement procedures.
  • the viscoelastic substance is especially useful for anterior chamber maintenance, but may also be used for posterior chamber maintenance where appropriate .
  • Anterior chamber maintenance is needed to maintain anterior chamber depth, lubrication or opening of capsular bag for lens extractions and intraocular lens implantation, and to create space by maintaining anterior chamber depth and protecting vitreous pressure.
  • a viscoelastic substance into the intraocular cavity also provides cell protection e.g. protection of corneal cells, iris and other delicate structures from intra-operative mechanical damage; replacement of a surgical tool in moving and maneuvering tissues during ophthalmic surgery; separation of tissues and synechiae; reduction or cessation of bleeding; and reduction of mechanical damage from surgical tools and intraocular lenses .
  • Viscoelastic substances have viscous gel-like properties at rest, become thin and watery when subjected to shear forces, and return to their viscous gel-like state when the shear force is removed.
  • An example of shear force is the passage of a viscoelastic substance through a cannula .
  • the viscoelastic substance will be viscous and gellike in the syringe, of thin and watery consistency during passage through the cannula, and will regain its viscous and gel-like consistency in the intraocular cavity of the eye .
  • the viscoelastic substance may be of any source e.g. from animal or plant tissue, by extraction from microorganisms, from production by microorganisms, by recombinant DNA technology or by chemical synthesis.
  • the characteristics of the viscoelastic substance will depend on the source of the material and its intended use. Parameters which determine the nature and characteristics of the viscoelastic substance include, viscosity, molecular weight and concentration in the solution.
  • viscoelastic substances are known to be suitable for introduction into the intraocular cavity during ophthalmic surgery. These substances may be used in the device of the invention.
  • viscoelastic substances suitable for use with the syringes of the invention include but are not limited to: glycosaminoglycans e.g. hyaluronic acid and salts thereof e.g.
  • alkali metal salts chondroitin sulfate, alginic acid, polymannuronic acid, polyglucuronic acid, and other polyglucuronic acids, mucopolysaccharides, polynucleic acids, polynucleosides, po lynuc 1 eo t ide s , polydeoxynuc le i c acids, polydeoxynucleosides, polyamino acids, collagen, and modified collagen, modified cellulose e.g.
  • Other viscoelastic substances are also encompassed by the scope of the invention.
  • the viscoelastic substance is used in the form of a physiologically acceptable solution, i.e. a solution which when in contact with tissues in the body are not harmful thereto.
  • the solution will have a suitable pH preferably in the range 4-8, and may also contain additional pharmacologically acceptable components, e.g. excipients, buffers, or other desired components.
  • the parameters of the viscoelastic substance in the solution are selected according to the desired viscosity.
  • the concentration is usually between 0.1% to 10% ' by weight, preferably 0.5%-4% by weight.
  • the molecular weight of the viscoelastic substance is from 0.05 to 10 million Daltons, preferably from 0.5 - 8 million Daltons, and more preferably from 1-6 million Daltons.
  • the molecular weight and concentration are selected so as to provide the desired viscosity appropriate for the surgical procedure to be performed. Additionally, different viscoelastic substances may be combined to provide a composition having the most optimal characteristics for the surgical procedure to be performed.
  • Preferred embodiments of the viscoelastic substance are solutions of hyaluronic acid or salts thereof, chondroitin sulfate, and hydroxypropylmethylcellulose, each alone or in various combinations of two or more.
  • the particular makeup of the viscoelastic composition will depend on the particular use for which the composition will be used.
  • a more preferred embodiment of the viscoelastic substance is the alkaline earth metal or ammonium salts of hyaluronic acid.
  • a particularly preferable embodiment of the viscoelastic substance comprises solution of sodium hyaluronate of molecular weight 2.5 - 3.5 million Daltons in a concentration of 1 - 1.5%.
  • the loaded single-use disposable device of this invention comprises a syringe and a viscoelastic substance.
  • the syringe includes a needle assembly means for introducing the viscoelastic substance into the intraocular cavity of a patient.
  • the needle is pointed at one end in order to penetrate the reservoir containing the viscoelastic substance, and is rounded at the other end for insertion into an incision made in the eye of the patient.
  • the needle is of a suitable gauge for use with viscoelastic materials, and preferably of 25-30 gauge, more preferably 27-30 gauge, most preferably 27 gauge.
  • the gauge of the needle is also influenced by the nature of the viscoelastic material being used. In this description, the terms “cannula” and “needle” are used interchangeably.
  • the syringe also is provided with a main body portion comprising a reservoir means containing the viscoelastic substance and for expelling the viscoelastic substance into the needle assembly.
  • the main body portion includes two sheets of thermoplastic material, wherein each of the two thermoplastic sheets is comprised of an expanded central portion, an expanded injection neck portion, an expanded filling neck portion, and a substantially flat peripheral portion.
  • the substantially flat peripheral portions of the two sheets of thermoplastic material are opposite and coextensive to each other and are sealed together face-to-face, and the expanded central portions are opposite and coextensive to each other, to form a reservoir for storing the viscoelastic substance.
  • the expanded injection neck portions extend from the expanded central portions to a first end of each sheet, and are opposite and coextensive to each other, to form an injection port extending from the reservoir and connected to the needle assembly means for directing the viscoelastic substance from the main body portion to the needle assembly means.
  • the expanded filling neck portions extend from the expanded central portions to a second end of each sheet, and are opposite and coextensive to each other, to form a filling port extending from the main body portion for filling the reservoir with the viscoelastic substance.
  • the expanded central portions are compressible, and in response to complete compression of both of the central portions together, the main body portion substantially collapses to prevent the reservoir from being reformed, and to expel the viscoelastic substance out of the reservoir.
  • the substantially flat peripheral portions of the two sheets of thermoplastic material are sealed together face-to-face prior to formation of the expanded portions of the two sheets.
  • the central portions of the two sheets, and the injection neck portions and filling neck portions extending therefrom, are expanded to form the reservoir, injection port, and filling port after the peripheral portions are sealed together, by injecting compressed gas between the appropriate portions of the two sheets or by drawing apart the appropriate portions of the two sheets using a vacuum, until those portions expand to fill a cavity of a mold.
  • the expanded central portions form a reservoir that comprises a compressible convex first dome, a compressible convex second dome, and a connecting member.
  • the connecting member which is coupled to the first and second domes, is provided for spacing apart the first and second domes, and for enabling the reservoir to substantially collapse in response to complete compression of both of the domes together. In response to complete compression of both of the domes together, each of the domes becomes concave to prevent the reservoir from being reformed .
  • the invention provides a loaded single-use disposable device for introducing a viscoelastic substance into the intraocular space of a patient ' s eye which comprises :
  • a syringe such syringe comprising:
  • a cylindrical bridging member coupled to the first and second end panels, for separating the first and second end panels, to enable each of the end panels to become concave in response to complete compression of the end panels together; and (c) a neck portion coupled to the needle portion and to the main body portion for directing the viscoelastic substance from the main body portion to the needle portion;
  • the main body portion in response to partial compression of both of the end panels together, the main body portion partially collapses to expel some of the viscoelastic substance out of the main body portion; and wherein the main body portion substantially collapses in response to complete compression of both the end panels together to prevent the main body portion from being reformed and to expel the viscoelastic substance out of the main body portion.
  • the device comprises a syringe which includes a needle assembly means for introducing the viscoelastic substance into the intraocular cavity of the patient.
  • the needle assembly means includes a needle.
  • a needle 12 is provided that is pointed at end 14 and round at end 16.
  • the round end of the needle is shown in detail in Figure 2A.
  • Figure 2B For comparison, and to more clearly distinguish from the syringes of the '871 and '473 patents, a detail of the corresponding needle end 16 of the syringes of the '871 and '473 patents is shown in Figure 2B.
  • the needle assembly means contains a hub means fastened to the needle for supporting the needle, and a tube for holding the needle and the hub means, having a closed end connected to an injection port and an open end.
  • the tube is provided by a nozzle 18
  • the hub means is provided by a needle hub 20
  • the closed end of the tube is formed by a pierceable nozzle membrane 22.
  • needle 12 passes through needle hub 20.
  • the needle hub is preferably made of polystyrene and is secured to needle 12 preferably using epoxy resin as an adhesive. Other suitable materials and adhesives may also be used.
  • nozzle 18 and needle hub 20 are cylindrical in shape.
  • needle hub 20 is comprised of a first section 24 of large diameter and a second section 26 of small diameter. The dimensions of large diameter first section 24 and of the internal diameter of nozzle 18 are selected so that needle hub 20 is frictionally held within nozzle 18, but can be moved laterally within nozzle 18 when a force is applied to needle hub 20.
  • the sharp pointed end 14 of needle 12 penetrates nozzle membrane 22 when needle hub 20 is moved toward the nozzle membrane.
  • the round end 16 of needle 12 is used to penetrate an incision made in the eye of the patient so that the viscoelastic substance can be introduced into the intraocular cavity.
  • nozzle 18 also is provided with an internal rib 28 between pierceable nozzle membrane 22 and needle hub 20 to prevent pointed end 14 of the needle from piercing the closed end of the tube (i.e. the nozzle membrane) unless a sufficient force is applied.
  • the dimensions of large diameter first section 24 and of internal rib 28 are selected so that needle hub 20 will not move past rib 28 unless a relatively larger force is applied to needle hub 20. This structure reduces the risk of unintentional piercing of nozzle membrane 22 at times when no one is ready to expel the viscoelastic substance from the main body portion.
  • the syringe portion of the device has a protector cap 30.
  • Protector cap 30 is a cylinder having a closed end 32 and an open end 34.
  • Protector cap 30 is long enough, together with nozzle 18, to enclose needle 12 without permitting the closed end of the protector cap to come into contact with flush end 16 of the needle.
  • the open end of the protector cap fits inside the nozzle, and preferably the external diameter of the open end is selected so that the protector cap is snugly held in position within nozzle 18. As a result, the needle is kept sterile and is not exposed during storage and shipment of the device.
  • protector cap 30 is removed in order to introduce the viscoelastic substance into the intraocular cavity of the patient.
  • the protector cap can be reinserted into nozzle 18 and used as a protective cover over the needle to prevent accidental stabbing by end 16.
  • the protector cap is preferably made of polyethylene.
  • the means for laterally moving the needle within the tube to pierce nozzle membrane 22 with pointed end 14 of needle 12 is provided by pressure of protector cap 30 on needle hub 20.
  • the internal diameter of open end 34 of the protector cap is selected so that the small diameter second section 26 of needle hub 20 fits snugly within the open end of the protector cap.
  • the external diameter of open end 34 of the protector cap is selected so that the protector cap can be moved laterally within nozzle 18. This design permits lateral movement of needle 12 without angular displacement of the needle as it moves toward and through nozzle membrane 22 at the closed end of nozzle 18.
  • the device of the invention can be more convenient for the surgeon to use than devices previously disclosed.
  • the device of the invention is easier to control because unlike existing devices, the device of the invention is held closely adjacent to the neck portion and consequently also to the needle portion. The surgeon is thus more easily able to control the expulsion of the viscoelastic substance from the main body portion, and also the movement of the needle within the eye of the patient in order to place the viscoelastic substance at the desired position within the eye.
  • Sodium hyaluronate was produced by a strain ' of Streptococcus C bacteria as described in U.S. Patent No. 4,784,990.
  • Sodium hyaluronate having a molecular weight of about 3 million daltons was purified from the bacterial culture as described in U.S. Patent No. 4,780,414.
  • a sterile, noninflammatory, non-pyrogenic composition was prepared containing 1% sodium hyaluronate in phosphate- buffered saline at pH 6.5-7.5.
  • the syringe portion of .the device of the invention is provided with a 27 gauge needle pointed at one end for penetration into the reservoir means and rounded at the other end.
  • the syringe is prepared to be sterile, and is sterile-filled through the filling port with the sodium hyaluronate composition free of air bubbles. The filling port is then heat sealed.
  • the syringe is then sealed in a foil packet and the entire packet sterilized.
  • the device of the invention is used during extracapsular cataract extraction (ECCE) to maintain anterior chamber depth and pupillary dilation, prevent curling up of the cut capsule edges, prevent corneal endothelial cell loss, and to serve as a surgical tool .
  • ECCE extracapsular cataract extraction
  • a second device of the invention is used during implantation of an intraocular lens (IOL) to prevent corneal endothelial cell loss and to facilitate the implantation.
  • IOL intraocular lens

Abstract

A loaded single use disposable device for introducing a viscoelastic substance into the intraocular space of a patient comprises a syringe (10) comprising a needle (20), a main body portion (40) including a compressible outwardly curved first end panel, a compressible outwardly curved second end panel, a cylindrical bridging member (44) coupled to the first and second end panels for separating the first and second end panels to enable each of the end panels to become concave in response to complete compression of the end panels together, and a neck portion (42) coupled to the needle (12) and to the main body portion (40) for directing the viscoelastic substance from the main body portion (40) to the needle (12).

Description

DEVICE FOR ADMINISTRATION OF VISCOELASTIC SUBSTANCE
This application claims priority of U.S. Serial No. 08/946,552, filed October 7, 1997, the content of which is hereby incorporated into this application by reference.
This invention is directed toward a device for introducing a viscoelastic substance inlto the intraocular cavity of a patient .
BACKGROUND
Many types of syringes are known in the art. All of the known syringes are different from the device of this invention, as will be described herewith.
Viscoelastic substances are well known for their use in intraocular surgery. These substances are compositions which are introduced into the eye during ocular (ophthalmic) surgery to maintain the ocular structure and protect the ocular tissue. The viscoelastic substance is introduced into the intraocular cavity by means of a syringe and needle (cannula) .
U.S. Patent No. 4,361,149 discloses an injection syringe in which the injectable substance is contained in an ampule sealed at the front end with a pierceable seal and at the other end with a plug serving as a piston. The syringe body contains a piercing point which upon piercing the pierceable seal of the ampule permits the pharmacological substance to pass into the needle upon exertion of pressure upon the plunger.
U.S. Patent Nos . 4,883,473 ('473) and 4,995,871 ('871) both assigned to PATH and incorporated by reference into the present specification, disclose a disposable single- use syringe formed of two sheets of expandable thermoplastic material having expanded central portions that form a pair of convex domes which together form a sealed reservoir to contain the injectable composition and which on partial compression are able to reform their original shape, resulting in aspiration of the needle to verify correct location of the needle, and upon complete compression collapse irreversibly to expel the medicament into the needle for injection. In these syringes, the injection is carried out by first moving the needle so as to penetrate the reservoir containing the composition for injection, permitting the composition to enter the needle and hence to be injected into the patient.
The syringes disclosed in the '473 and '871 patents are described for intravenous (IV) or intramuscular (IM) injection of e.g. drugs and vaccines. Neither of these patents teach or suggest viscoelastic substances, nor the use of these syringes for introducing a viscoelastic substance into the intraocular cavity of the eye of a patient in the course of ophthalmic surgery.
The main advantages of these syringes as set forth in the '473 and '871 patents are that (1) after the syringe has been used for its designated purpose, it cannot be reused for any other application, and (2) the design of the syringe permits aspiration of the needle at the start of the injection procedure so as to allow verification of the proper location of the needle i.e. in the vein or muscle as appropriate. These syringes are also said to be inexpensive to manufacture and therefore appropriate for developing countries where there is a need for wide scale immunization together with economic limitations on the use of other known but more expensive syringes. In addition, the extreme ease of use of this syringe in comparison to other syringes, and the feature of non-reusability make it especially suitable for use outside of formal health care facilities and by other than highly trained health care personnel . None of these considerations are relevant to the device of the present invention for introducing a viscoelastic substance into the intraocular cavity of the eye of a patient. Firstly, there is no issue of reuse because the device of the present invention is intended to be used only in formal health care facilities e.g. hospitals, and by highly trained health care personnel i.e. physicians and surgeons. Secondly, there is no need and no advantage for aspiration of the needle at the start of the procedure. None of the prior disclosures teach or suggest the device of the present invention or its intended use for introducing a viscoelastic substance into the intraocular cavity of the eye of a patient during surgery.
Unlike the syringes of the prior art which are disclosed as being used for injection of drugs and vaccines, the device of this invention is for introduction of a viscous or viscoelastic substance into the intraocular cavity of a patient ' s eye .
Furthermore, the syringes of the '871 and '473 patents are intended for administration of compositions comprising non-viscous solutions. The needle appropriate for use with a non-viscous substance is different from the needle appropriate for a viscous or viscoelastic substance. Unlike the '871 and '473 patents which do not disclose the gauge of the needle , a viscoelastic substance must be administered specifically with a narrow gauge needle which will exert the shear forces necessary to reduce the viscosity of the viscoelastic substance in order to permit injection. A narrow gauge needle also facilitates delicate maneuvering within the eye, and reduces the risk of damage to the tissues and organelles of the eye.
The needles disclosed for use with the syringe of the '871 and '473 patents are hypodermic needles and have both ends pointed. One end is pointed to penetrate into the reservoir means containing the injectable composition, and the other end is pointed to penetrate the skin of the patient receiving the injection. Unlike the needle of the prior art syringe which is pointed at both ends, the needle component of the device of the present invention is not pointed but rounded at the end which is used to introduce the viscoelastic substance into the intraocular cavity to permit passage of the needle through an incision previously cut into the eye of the patient's eye.
Different types of devices are known for the introduction of a viscoelastic substance into the intraocular cavity. For example, Healon® is a device comprised of a syringe containing a composition of hyaluronic acid contained in an ampule inside the syringe. Depressing the plunger of the syringe results in the seal of the ampule being punctured by a piercing point integral to the body of the syringe. Further pressure on the plunger results in the expulsion of the hyaluronic acid composition from the ampule into a needle (cannula) and from there into the intraocular cavity. The needle is supplied separately and must be assembled onto the syringe before use.
This additional step of assembly of the needle onto the syringe presents an additional complexity in the use of the device. Improper assembly of the needle could lead to disassembly during use with all the problems such an occurrence would cause such as violation of sterility, leakage of the viscoelastic from the syringe, etc. Furthermore, this form of needle has been known to allow the injection of air bubbles into the eye. Additionally, the costs of manufacturing this device are quite considerable due its complexity e.g. need for separate syringe, ampule, plunger, needle, etc. and the assembly and sterilization of this system. The attendant costs result in a high ultimate price of the end-product which poses a considerable burden on consumers of the product i.e. health services and patients. Another device for delivery of a viscoelastic is BIOLON® which is a prefilled disposable glass syringe containing a viscoelastic composition of hyaluronic acid. BIOLON® is equipped with a special needle assembly. This needle assembly consists of two needle components of two different diameters soldered together, and contained inside a metal sleeve to which they also are soldered. The needle assembly was specially designed so that the needle, unlike ordinary needle assemblies, on assembly to the syringe is actually inserted into the body of the syringe. In addition, the needle end is bent to facilitate its use and manipulation by the surgeon. The incorporation of all of these features into the needle assembly results in a high cost of manufacture of the needle which cost of course must be included in the price of the device. All these attendant costs result in a high ultimate price of the end-product which poses a considerable burden on consumers of the product i.e. health services and patients.
Other devices for administration of viscoelastic substances for intraocular use are also known. All of these devices consist of a prefilled syringe containing the viscoelastic substance. These devices are expensive to manufacture. In contrast the device of the invention is inexpensive to manufacture, and therefore presents a significant economic advantage to consumers of the product i.e. health service providers and patients.
To solve the aforementioned problems and deficiencies of existing products, the present invention provides a loaded single use device for introducing a viscoelastic substance into the intraocular cavity of a patient during ophthalmic surgery.
This invention also relates to the use of this device for introducing a viscoelastic substance into the intraocular cavity of a patient during ophthalmic surgery. SUMMARY OF INVENTION
The invention comprises a loaded single-use disposable device for introducing a viscoelastic substance into the intraocular space of a patient which comprises:
(1) a syringe, such syringe comprising :
(a) a needle portion for introducing the viscoelastic substance into the intraocular space of the patient's eye;
(b) a main body portion for storing the viscoelastic substance and for expelling the viscoelastic substance into the needle portion, the main body portion including:
(i) a compressible outwardly curved first end panel, (ii) a compressible outwardly curved second end panel, and (iii) a cylindrical bridging member, coupled to the first and second end panels, for separating the first and second end panels, to enable each of the end panels to become concave in response to complete compression of the end panels together; and
(c) a neck portion coupled to the needle portion and to the main body portion for directing the viscoelastic substance from the main body portion to the needle portion;
(2) a composition comprising the viscoelastic substance within the main body portion
wherein in response to partial compression of both of the end panels together, the main body portion partially collapses to expel some of the viscoelastic substance out of the main body portion; and wherein the main body portion substantially collapses in response to complete compression of both the end panels together to prevent the main body portion from being reformed and to expel the viscoelastic substance out of the main body portion.
BRIEF DESCRIPTION OF THE FIGURES
Figure 1 is a diagram of the syringe portion of the device of the invention.
Figure 2A shows a detail of needle point 16 of Figure 1. Figures 2B shows the corresponding needle point of the syringe disclosed in the '871 and '473 patents.
DETAILED DESCRIPTION OF THE INVENTION
An important procedure in the course of many ophthalmic surgical procedures is the introduction of a viscoelastic substance into the intraocular cavity in order to maintain ocular structure and protect ocular tissue.
The clinical indications for the introduction of a viscoelastic substance into the intraocular cavity include, but are not limited to ophthalmic or ocular surgery for treatment of cataract comprising intracapsular and extracapsular lens extraction and lens insertion, phacoemulsification, glaucoma surgery, corneal surgery for accidental trauma, retinal detachment and vitreal replacement procedures. The viscoelastic substance is especially useful for anterior chamber maintenance, but may also be used for posterior chamber maintenance where appropriate .
Anterior chamber maintenance is needed to maintain anterior chamber depth, lubrication or opening of capsular bag for lens extractions and intraocular lens implantation, and to create space by maintaining anterior chamber depth and protecting vitreous pressure.
Uses of viscoelastic substances in ophthalmic surgery are reviewed in Lindstrom et al . Ophthalmology Clinics of North America, Vol. 2, No. 1, pages 173-186 (1989) and Thomas J. Liesegang, Survey of Ophthalmology, Vol 34, No. 4, pages 268-293, (1990).
Introduction of a viscoelastic substance into the intraocular cavity also provides cell protection e.g. protection of corneal cells, iris and other delicate structures from intra-operative mechanical damage; replacement of a surgical tool in moving and maneuvering tissues during ophthalmic surgery; separation of tissues and synechiae; reduction or cessation of bleeding; and reduction of mechanical damage from surgical tools and intraocular lenses .
Viscoelastic substances have viscous gel-like properties at rest, become thin and watery when subjected to shear forces, and return to their viscous gel-like state when the shear force is removed. An example of shear force is the passage of a viscoelastic substance through a cannula . Thus, the viscoelastic substance will be viscous and gellike in the syringe, of thin and watery consistency during passage through the cannula, and will regain its viscous and gel-like consistency in the intraocular cavity of the eye .
The viscoelastic substance may be of any source e.g. from animal or plant tissue, by extraction from microorganisms, from production by microorganisms, by recombinant DNA technology or by chemical synthesis.
The characteristics of the viscoelastic substance will depend on the source of the material and its intended use. Parameters which determine the nature and characteristics of the viscoelastic substance include, viscosity, molecular weight and concentration in the solution.
Many viscoelastic substances are known to be suitable for introduction into the intraocular cavity during ophthalmic surgery. These substances may be used in the device of the invention. Examples of viscoelastic substances suitable for use with the syringes of the invention include but are not limited to: glycosaminoglycans e.g. hyaluronic acid and salts thereof e.g. alkali metal salts; chondroitin sulfate, alginic acid, polymannuronic acid, polyglucuronic acid, and other polyglucuronic acids, mucopolysaccharides, polynucleic acids, polynucleosides, po lynuc 1 eo t ide s , polydeoxynuc le i c acids, polydeoxynucleosides, polyamino acids, collagen, and modified collagen, modified cellulose e.g. methylcellulose, hydroxymethylcellulose, hydroxyethylcellullose, hydroxypropylcellulose, and hydroxypropylmethylcellulose; polyvinyl pyrrolidone, polyacrylamide, polyvinyl alcohol, carboxyvinyl polymer, chitin, polyethyleneimine, polyhydroxyethylmethacrylate and other methacrylic or acrylic acid polymers. Other viscoelastic substances are also encompassed by the scope of the invention.
The viscoelastic substance is used in the form of a physiologically acceptable solution, i.e. a solution which when in contact with tissues in the body are not harmful thereto. The solution will have a suitable pH preferably in the range 4-8, and may also contain additional pharmacologically acceptable components, e.g. excipients, buffers, or other desired components.
The parameters of the viscoelastic substance in the solution are selected according to the desired viscosity. The concentration is usually between 0.1% to 10% 'by weight, preferably 0.5%-4% by weight. The molecular weight of the viscoelastic substance is from 0.05 to 10 million Daltons, preferably from 0.5 - 8 million Daltons, and more preferably from 1-6 million Daltons. The molecular weight and concentration are selected so as to provide the desired viscosity appropriate for the surgical procedure to be performed. Additionally, different viscoelastic substances may be combined to provide a composition having the most optimal characteristics for the surgical procedure to be performed.
Preferred embodiments of the viscoelastic substance are solutions of hyaluronic acid or salts thereof, chondroitin sulfate, and hydroxypropylmethylcellulose, each alone or in various combinations of two or more. The particular makeup of the viscoelastic composition will depend on the particular use for which the composition will be used.
A more preferred embodiment of the viscoelastic substance is the alkaline earth metal or ammonium salts of hyaluronic acid. A particularly preferable embodiment of the viscoelastic substance comprises solution of sodium hyaluronate of molecular weight 2.5 - 3.5 million Daltons in a concentration of 1 - 1.5%.
To achieve the objects and in accordance with the purpose of the invention, as embodied and broadly described herein, the loaded single-use disposable device of this invention comprises a syringe and a viscoelastic substance. The syringe includes a needle assembly means for introducing the viscoelastic substance into the intraocular cavity of a patient. The needle is pointed at one end in order to penetrate the reservoir containing the viscoelastic substance, and is rounded at the other end for insertion into an incision made in the eye of the patient. The needle is of a suitable gauge for use with viscoelastic materials, and preferably of 25-30 gauge, more preferably 27-30 gauge, most preferably 27 gauge. However, the gauge of the needle is also influenced by the nature of the viscoelastic material being used. In this description, the terms "cannula" and "needle" are used interchangeably.
The syringe also is provided with a main body portion comprising a reservoir means containing the viscoelastic substance and for expelling the viscoelastic substance into the needle assembly. The main body portion includes two sheets of thermoplastic material, wherein each of the two thermoplastic sheets is comprised of an expanded central portion, an expanded injection neck portion, an expanded filling neck portion, and a substantially flat peripheral portion. The substantially flat peripheral portions of the two sheets of thermoplastic material are opposite and coextensive to each other and are sealed together face-to-face, and the expanded central portions are opposite and coextensive to each other, to form a reservoir for storing the viscoelastic substance. The expanded injection neck portions extend from the expanded central portions to a first end of each sheet, and are opposite and coextensive to each other, to form an injection port extending from the reservoir and connected to the needle assembly means for directing the viscoelastic substance from the main body portion to the needle assembly means.
The expanded filling neck portions extend from the expanded central portions to a second end of each sheet, and are opposite and coextensive to each other, to form a filling port extending from the main body portion for filling the reservoir with the viscoelastic substance.
The expanded central portions are compressible, and in response to complete compression of both of the central portions together, the main body portion substantially collapses to prevent the reservoir from being reformed, and to expel the viscoelastic substance out of the reservoir.
In one embodiment of the single-use disposable device of the invention, the substantially flat peripheral portions of the two sheets of thermoplastic material are sealed together face-to-face prior to formation of the expanded portions of the two sheets. The central portions of the two sheets, and the injection neck portions and filling neck portions extending therefrom, are expanded to form the reservoir, injection port, and filling port after the peripheral portions are sealed together, by injecting compressed gas between the appropriate portions of the two sheets or by drawing apart the appropriate portions of the two sheets using a vacuum, until those portions expand to fill a cavity of a mold.
In another embodiment of the single-use disposable device, the expanded central portions form a reservoir that comprises a compressible convex first dome, a compressible convex second dome, and a connecting member. The connecting member, which is coupled to the first and second domes, is provided for spacing apart the first and second domes, and for enabling the reservoir to substantially collapse in response to complete compression of both of the domes together. In response to complete compression of both of the domes together, each of the domes becomes concave to prevent the reservoir from being reformed .
Accordingly, the invention provides a loaded single-use disposable device for introducing a viscoelastic substance into the intraocular space of a patient ' s eye which comprises :
(1) a syringe, such syringe comprising :
(a) a needle portion for introducing the viscoelastic substance into the intraocular space of the patient's eye;
(b) a main body portion for storing the viscoelastic substance and for expelling the viscoelastic substance into the needle portion, the main body portion including:
(i) a compressible outwardly curved first end panel, (ii) a compressible outwardly curved second end panel, and
(iii) a cylindrical bridging member, coupled to the first and second end panels, for separating the first and second end panels, to enable each of the end panels to become concave in response to complete compression of the end panels together; and (c) a neck portion coupled to the needle portion and to the main body portion for directing the viscoelastic substance from the main body portion to the needle portion;
(2) a composition comprising the viscoelastic substance within the main body portion
wherein in response to partial compression of both of the end panels together, the main body portion partially collapses to expel some of the viscoelastic substance out of the main body portion; and wherein the main body portion substantially collapses in response to complete compression of both the end panels together to prevent the main body portion from being reformed and to expel the viscoelastic substance out of the main body portion.
Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. 'An embodiment of the syringe portion of the single -use disposable device for introducing a viscoelastic substance into the intraocular cavity of a patient is shown in Figure 1.
In accordance with the invention, the device comprises a syringe which includes a needle assembly means for introducing the viscoelastic substance into the intraocular cavity of the patient. The needle assembly means includes a needle. As embodied in the syringe portion of the device shown in Figure 1, a needle 12 is provided that is pointed at end 14 and round at end 16. The round end of the needle is shown in detail in Figure 2A. For comparison, and to more clearly distinguish from the syringes of the '871 and '473 patents, a detail of the corresponding needle end 16 of the syringes of the '871 and '473 patents is shown in Figure 2B.
The needle assembly means contains a hub means fastened to the needle for supporting the needle, and a tube for holding the needle and the hub means, having a closed end connected to an injection port and an open end. Preferably, the tube is provided by a nozzle 18, the hub means is provided by a needle hub 20, and the closed end of the tube is formed by a pierceable nozzle membrane 22.
As illustrated in Figure 1, needle 12 passes through needle hub 20. The needle hub is preferably made of polystyrene and is secured to needle 12 preferably using epoxy resin as an adhesive. Other suitable materials and adhesives may also be used. In this embodiment, nozzle 18 and needle hub 20 are cylindrical in shape. Preferably, needle hub 20 is comprised of a first section 24 of large diameter and a second section 26 of small diameter. The dimensions of large diameter first section 24 and of the internal diameter of nozzle 18 are selected so that needle hub 20 is frictionally held within nozzle 18, but can be moved laterally within nozzle 18 when a force is applied to needle hub 20. The sharp pointed end 14 of needle 12 penetrates nozzle membrane 22 when needle hub 20 is moved toward the nozzle membrane. The round end 16 of needle 12 is used to penetrate an incision made in the eye of the patient so that the viscoelastic substance can be introduced into the intraocular cavity.
As embodied herein, nozzle 18 also is provided with an internal rib 28 between pierceable nozzle membrane 22 and needle hub 20 to prevent pointed end 14 of the needle from piercing the closed end of the tube (i.e. the nozzle membrane) unless a sufficient force is applied. The dimensions of large diameter first section 24 and of internal rib 28 are selected so that needle hub 20 will not move past rib 28 unless a relatively larger force is applied to needle hub 20. This structure reduces the risk of unintentional piercing of nozzle membrane 22 at times when no one is ready to expel the viscoelastic substance from the main body portion.
Means are provided for protecting the needle. As shown in Figure 1, the syringe portion of the device has a protector cap 30. Protector cap 30 is a cylinder having a closed end 32 and an open end 34. Protector cap 30 is long enough, together with nozzle 18, to enclose needle 12 without permitting the closed end of the protector cap to come into contact with flush end 16 of the needle. The open end of the protector cap fits inside the nozzle, and preferably the external diameter of the open end is selected so that the protector cap is snugly held in position within nozzle 18. As a result, the needle is kept sterile and is not exposed during storage and shipment of the device. Following the piercing of nozzle membrane 22, protector cap 30 is removed in order to introduce the viscoelastic substance into the intraocular cavity of the patient. After the device has been used, the protector cap can be reinserted into nozzle 18 and used as a protective cover over the needle to prevent accidental stabbing by end 16. As embodied herein, the protector cap is preferably made of polyethylene. The means for laterally moving the needle within the tube to pierce nozzle membrane 22 with pointed end 14 of needle 12 is provided by pressure of protector cap 30 on needle hub 20. The internal diameter of open end 34 of the protector cap is selected so that the small diameter second section 26 of needle hub 20 fits snugly within the open end of the protector cap. The external diameter of open end 34 of the protector cap is selected so that the protector cap can be moved laterally within nozzle 18. This design permits lateral movement of needle 12 without angular displacement of the needle as it moves toward and through nozzle membrane 22 at the closed end of nozzle 18.
The device of the invention can be more convenient for the surgeon to use than devices previously disclosed. The device of the invention is easier to control because unlike existing devices, the device of the invention is held closely adjacent to the neck portion and consequently also to the needle portion. The surgeon is thus more easily able to control the expulsion of the viscoelastic substance from the main body portion, and also the movement of the needle within the eye of the patient in order to place the viscoelastic substance at the desired position within the eye.
EXAMPLES
The invention may be better understood with reference to the accompanying examples which are intended to be illustrative only and should not be viewed in any sense as limiting the scope of the invention which is defined hereinafter in the accompanying claims.
Example 1
Sodium hyaluronate was produced by a strain ' of Streptococcus C bacteria as described in U.S. Patent No. 4,784,990. Sodium hyaluronate having a molecular weight of about 3 million daltons was purified from the bacterial culture as described in U.S. Patent No. 4,780,414. A sterile, noninflammatory, non-pyrogenic composition was prepared containing 1% sodium hyaluronate in phosphate- buffered saline at pH 6.5-7.5.
The syringe portion of .the device of the invention is provided with a 27 gauge needle pointed at one end for penetration into the reservoir means and rounded at the other end. The syringe is prepared to be sterile, and is sterile-filled through the filling port with the sodium hyaluronate composition free of air bubbles. The filling port is then heat sealed.
The syringe is then sealed in a foil packet and the entire packet sterilized.
Example 2
The device of the invention is used during extracapsular cataract extraction (ECCE) to maintain anterior chamber depth and pupillary dilation, prevent curling up of the cut capsule edges, prevent corneal endothelial cell loss, and to serve as a surgical tool .
Subsequently in a secondary operation, a second device of the invention is used during implantation of an intraocular lens (IOL) to prevent corneal endothelial cell loss and to facilitate the implantation. REFERENCES ;
1. U.S. Patent No. 4,361,149 to δrder, issued November 30, 1982.
2. U.S. Patent No. 4,883,473 to Thomas, issued November 28, 1989.
3. U.S. Patent No. 4,955,871 to Thomas, issued September 11, 1990.

Claims

CLAIMSWhat is claimed is :
1. A loaded single-use disposable device for introducing a solution of hyaluronic acid or a salt thereof into the intraocular space of a patient's eye which comprises :
(1) a syringe, such syringe comprising :
(a) a needle portion for introducing the hyaluronic acid or salt thereof into the intraocular space of a patient's eye; (b) a main body portion comprising a reservoir means for storing the hyaluronic acid or salt thereof and for expelling the hyaluronic acid or salt thereof into the needle portion, the main body portion including:
(i) a compressible outwardly curved first end panel,
(ii) a compressible outwardly curved second end panel, and (iii) a cylindrical bridging member, coupled to the first and second end panels, for separating the first and second end panels, to enable each of the end panels to become concave in response to complete compression of the end panels together; and
(c) a neck portion coupled to the needle portion and to the main body portion for directing the hyaluronic acid or salt thereof from the main body portion to the needle portion; and (2) a composition comprising hyaluronic acid or a salt thereof within the main body portion of the syringe
wherein in response to partial compression of both of the end panels together, the main body portion partially collapses to expel some of the composition of hyaluronic acid or salt thereof out of the main body portion; and wherein the main body portion substantially collapses in response to complete compression of both the end panels together to prevent the main body portion from being reformed and to expel the composition of hyaluronic acid or salt thereof out of the main body portion.
2. The device of claim 1, wherein the needle portion comprises a needle pointed at one end but not at the other end, wherein the pointed end is directed toward the main body portion, and the other end is directed outward from the main body portion.
3. The device of claim 2, wherein the needle is supported in a cylindrical hub portion.
4. The device of claim 3, wherein the cylindrical hub portion has a portion of wider diameter located in the direction of the main body portion, and a portion of narrower diameter axially located adjacent to the wider diameter portion and on the flat end of the wider diameter portion facing opposite to the main body portion.
5. The device of claim 1 wherein the main body portion contains a filling port and which filling port is heat sealable following the filling of the main body portion with the composition of hyaluronic acid' or salt thereof.
6. The device of claim 1 wherein the neck portion is cylindrical and comprises a pierceable membrane.
7. The device of claim 6 wherein the diameter of the neck portion is of an appropriate width so as to provide frictional resistance to movement of the needle assembly in the direction of the pierceable membrane .
8. The device of claim 7 wherein exertion of a sufficient lateral force on the needle portion will cause it to move in the direction of the pierceable membrane, so that the needle punctures the membrane permitting the composition of hyaluronic acid or salt thereof to flow from the main body portion to the needle portion in response to compression of the end panels of the main body portion.
9. The device of claim 1 wherein the composition comprising hyaluronic acid or salt thereof is comprised of sodium hyaluronate.
10. The device of claim 9 wherein the sodium hyaluronate has a molecular weight of 1 - 6 million daltons.
11. The device of claim 9 wherein the sodium hyaluronate is present in the composition in a concentration of 0.5-10%.
12. A method of introducing into the intraocular cavity of a patient a composition comprising hyaluronic acid or salt thereof which comprises so introducing the composition using the device of claim 1.
13. The use of the device of claim 1 for introducing into the intraocular cavity of a patient a composition comprising hyaluronic acid or salt thereof .
14. A loaded, single-use, disposable device for introducing a viscoelastic substance into the intraocular space of a patient's eye which comprises:
(1) a syringe, such syringe comprising :
(a) a needle portion for introducing the viscoelastic substance into the intraocular space of a patient's eye; (b) a main body portion for storing the viscoelastic substance and for expelling the viscoelastic substance into the needle portion, the main body portion including:
(i) a compressible outwardly curved first end panel,
(ii) a compressible outwardly curved second end panel, and (iii) a cylindrical bridging member, coupled to the first and second end panels, for separating the first and second end panels, to enable each of the end panels to become concave in response to complete compression of the end panels together; and c) a neck portion coupled to the needle portion and to the main body portion for directing the viscoelastic substance from the main body portion to the needle portion; and
(2) a composition comprising the viscoelastic substance within the main body portion of the syringe
wherein in response to partial compression of both of the end panels together, the main body portion partially collapses to expel some of the composition of the viscoelastic substance out of the main body portion; and wherein the main body portion substantially collapses in response to complete compression of both the end panels together to prevent the main body portion from being reformed and to expel the composition of the viscoelastic substance out of the main body portion.
15. The device of claim 14, wherein the needle portion comprises a needle pointed at one end but not at the other end, wherein the pointed end is directed toward the main body portion, and the other end is directed outward from the main body portion.
16. A method of introducing into the intraocular cavity of a patient a composition comprising a viscoelastic substance which comprises so introducing the composition using the device of claim 14.
17. The use of the device of claim 14 for introducing into the intraocular cavity of a patient a composition comprising a viscoelastic substance.
PCT/US1998/021001 1997-10-07 1998-10-07 Device for administration of viscoelastic substance WO1999017821A1 (en)

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WO2009063291A1 (en) * 2007-11-13 2009-05-22 Bio-Technology General (Israel) Ltd. Dilute filtration sterilization process for viscoelastic biopolymers
WO2014026694A1 (en) * 2012-08-14 2014-02-20 Injector Aps Disposable injector
US8662349B2 (en) 2009-08-30 2014-03-04 Aktivpak, Inc. Dispensing device incorporating frangible section, along with dispensing method
WO2015070275A1 (en) * 2013-11-18 2015-05-21 Werner Grosschädl Device for rinsing the tear duct of an eye

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US5040706A (en) * 1989-03-17 1991-08-20 Insite Vision, Inc. Liquid droplet dispensing apparatus

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009063291A1 (en) * 2007-11-13 2009-05-22 Bio-Technology General (Israel) Ltd. Dilute filtration sterilization process for viscoelastic biopolymers
JP2011503047A (en) * 2007-11-13 2011-01-27 バイオ−テクノロジー ゼネラル（イスラエル）リミテッド Dilution filtration sterilization process for viscoelastic biopolymers
AU2008322629B2 (en) * 2007-11-13 2013-05-16 Bio-Technology General (Israel) Ltd. Dilute filtration sterilization process for viscoelastic biopolymers
US9896518B2 (en) 2007-11-13 2018-02-20 Bio-Technology General (Israel) Ltd. Dilute filtration sterilization process for viscoelastic biopolymers
US8662349B2 (en) 2009-08-30 2014-03-04 Aktivpak, Inc. Dispensing device incorporating frangible section, along with dispensing method
WO2014026694A1 (en) * 2012-08-14 2014-02-20 Injector Aps Disposable injector
WO2015070275A1 (en) * 2013-11-18 2015-05-21 Werner Grosschädl Device for rinsing the tear duct of an eye

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