Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
  • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
• • 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
  • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
• • 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
  • A61F9/00772—Apparatus for restoration of tear ducts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0048—Eye, e.g. artificial tears
  • A61K9/0051—Ocular inserts, ocular implants
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
  • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity

Definitions

• This invention relates broadly to medical devices. More particularly, this invention relates to medical device adapted to store and release medication.
• drugs are administered to the eye.
• the most common form of drug delivery is by topical application to the eye's surface, e.g., by drops.
• the eye is uniquely suited to surface administration because drugs can penetrate through the cornea, rise to therapeutic concentration levels inside the eye, and exert their beneficial effects.
• ninety five percent of drugs delivered to the eye are currently administered through eye drops.
• drugs for the eye administered orally or by injection either because they reach the eye in too low a concentration to have the desired pharmacological effect, or because their use is complicated by significant systemic side effects.
• Topical eye drops are inefficient.
• an eye drop When an eye drop is instilled in the eye, it overfills the conjunctival sac, the pocket between the eye and the lids, causing a substantial portion of the drop to be lost due to overflow of the lid margin onto the cheek.
• a substantial portion of the drop remaining on the ocular surface is washed away into the nasolacrimal duct, thereby diluting the concentration of the drug.
• this portion of the drug dose lost before it can cross the cornea but this excess drug may be undesirably carried into the nose and throat where it is absorbed into the local or general circulation, sometimes leading to serious systemic side effects.
• U.S. Pat. No. 3,949,750 to Freeman describes a punctum plug manufactured of a porous material which stores and slowly dispenses an ophthalmic medication to the eye.
• the Freeman plug overcomes many of the negative of topical administration, as a large proportion of the slowly dispensed medication is subject to a level rate of uptake at the eye without overflow of the conjunctival sac. If there is any drawback to the Freeman plug, it is that the dose of medication which can be stored in a solid porous plug is relatively small.
• U.S. Pat. No. 6,196,993 to Cohan et al. describes a punctum plug having a reservoir within the body of the plug adapted for storing a larger quantity of medication, and a collarette having a pore in communication with the reservoir.
• the reservoir has a closed lower end and an upper portion open to the pore.
• the medication stored in the reservoir is released through the pore to the surface of the eye over time, with pore size adapted to control release rate of the medication.
• a medication-permeable material is provided over the pore.
• the plug itself is shown manufactured in the patent in one piece from silicone or another material that is impermeable to the medication.
• the Cohan device cannot be manufactured as a one-piece plug.
• a lacrimal insert is provided with a reservoir for storing a medication, such as a glaucoma, antimicrobial, anti ⁇ inflammatory, dry-eye syndrome medication and which, for purposes herein, shall also include a therapeutic such as a mydriatic or a cycloplegic.
• the lacrimal insert is a punctum plug comprising a body having a neck end, a tip end and a centrally defined reservoir, and a head provided at the neck end of the body and enclosing the reservoir.
• the body is made from a first material which is substantially impermeable to the medication while the head is made from a second material which is permeable to the medication and adapted to release the medication from the reservoir to the eye at a determinable rate.
• the body in a first step, is molded from the first material to define the reservoir.
• the internal space defining the reservoir is molded open at both the neck and tip ends.
• the head is molded from the second material onto the neck end of the body.
• the medication is injected into the reservoir of the plug through the tip end opening of the body.
• the open tip end of the body is provided with a cork-like seal to close the reservoir.
• the reservoir is sealed at a location away from the area of medication permeability.
• the body is molded with an internal space open only at the neck end.
• the head is then attached to the body prior to filing with medication.
• a needle is punctured through the body to inject the medication and then withdrawn, with the body self- healing to retain the medication.
• a lacrimal insert design is provided which is adapted to release medication into the lacrimal duct, e.g., sinus or throat medications as opposed to at the ocular surface.
• the body is molded of a first relatively impermeable material with head, neck and a flared portions.
• the head portion defines an opening for injecting a medication.
• a tip molded of a second relatively more permeable material is then provided at the end of the flared portion. Medication is injected into the body to fill a reservoir defined between the body and tip, and a seal is then provided in the opening in the head portion to close the reservoir.
• the first and second materials are preferably two types of silicone, one relatively impermeable to the medication, and the other having a suitable rate of permeability for the medication.
• the portion of the insert at which the medication is released is precisely fabricated in order to control release of the medication, and the reservoir is filled and then closed away from the area of permeability.
• Fig. 1 is a schematic section view of a punctum plug according to a first embodiment of the invention
• Figs. 2 through 5 illustrate a method of manufacturing the punctum plug of Fig. 1;
• Figs. 6 and 7 illustrate a method of manufacturing a second embodiment of a punctum plug according to the invention
• Figs. 8 through 10 illustrate a method of manufacturing a third embodiment of a punctum plug according to the invention.
• Fig. 11 is a schematic section view of a monocanalicular insert according to another embodiment of the invention.
• the punctum plug 10 includes a body 12 defining a reservoir 14, a neck portion 16, a flared portion 18, and a tapered portion 20 terminating in a tip 22.
• a non-porous head 24 is provided over the neck portion 16 of the body 12 and encloses the reservoir.
• a medication 26 is provided in the reservoir.
• the body 12 and head 24 are made of different materials, with the body 12 being made from a biocompatible, preferably soft and flexible first material which is relatively impermeable to the medication, and the head 24 being made from a biocompatible, preferably soft and flexible second material which is permeable to the medication.
• both materials are silicones.
• silicones of selective permeability are available from NuSiI Technology of Carpinteria, CA.
• Other suitable materials may also be used. Materials may be selected to affect the rate of release of medication through the head 24 of the plug 10 (or other plug location, as discussed below with respect to Figs. 8 through 10).
• the second material is preferably chosen for its desired rate of release with respect to a particular medication.
• the body 12 in a first step, is molded from the first material to define the reservoir 14 having a larger diameter neck end 30, a tapered portion 32 and an open tip 34.
• the internal space defining the reservoir is molded open at both the neck and tip ends.
• the head 24 is molded from the second material onto the neck portion 16 of the body 12.
• the end of the neck portion 16 may be provided with a flare 36 to facilitate molded engagement with the head 24.
• the medication 26 is injected with a needle 38 or other suitable device into the reservoir 14 of the plug 10 through the open tip 34.
• a medication impermeable stopper 40 is provided to close the reservoir 14.
• the stopper 40 is preferably made of silicone or PTFE, though other suitable materials can be used.
• a sealant may be 'painted' onto the plug at the site of the opening to provide the seal. Therefore, in accord with the invention, the reservoir 14 is sealed at a location away from the area of medication permeability, and most preferably at a location opposite the head 24.
• the portion of the plug at which the medication is released is precisely fabricated in order to control medication release, and the medication reservoir is closed away from the area of permeability so as not to interfere with such permeability.
• the plug 10 is sized for insertion into a portion of the lacrimal canaliculus of a human eye, with the head and body anchored by the punctum. When so inserted (in accord with technique well known in the art), the medication is released from the plug to the ocular surface over time at the predetermined rate to provide medicinal or therapeutic benefit.
• a second method of manufacturing a plug 110 according to the invention is shown.
• the body 112 of the plug is made from a self-healing material, with an internal space 114 open only at the neck end 136.
• the head 124 is then attached to the body 112 prior to filing the reservoir space 114 with medication.
• a needle 138 or similar device is punctured through the body 112 to inject the medication 126. After injecting the medication 126, the needle 138 is withdrawn, with the body self-healing to retain the medication 126.
• a plug 210 (Fig. 10) is provided adapted to release medication into the lacrimal duct, e.g., allergy, sinus or throat medications, rather than to the surface of the eye.
• the body 212 is molded of the first relatively impermeable material with head 224, neck 216 and a flared open end 218.
• the head portion 224 defines an opening 242.
• a tip 244 of a second relatively more permeable material is molded onto the flared open end 218 to define a reservoir within the body 212 and preferably a portion of the tip 244.
• Medication 226 is injected through the opening 242 into the reservoir 214.
• a stopper 240 is provided in the opening in the head portion to close the reservoir 214.
• This embodiment may also be designed without a seal; i.e., in the manner of using a self-healing body material, as described above.
• a lacrimal insert 310 is shown.
• the insert 310 shown may be manufactured in accord with any of the methods described above to release medication at the head end or tip end.
• the insert 310 is manufactured with a body 312 having an elongate distal tubular portion 360 preferably angled relative to a neck 316 of the body.
• the body 312 and tubing portion 360 define a reservoir 314 of substantially greater volume than in the other embodiments.
• the head 324 is molded onto the neck 316 of the body 312 of a second relatively permeable material.
• Medication 326 is provided in the reservoir through the open end 362 of the tubular portion 360 and a preferably medication-impermeable stopper element 340 is used to close the reservoir 314.
• the portion of the insert at which the medication is released is precisely fabricated in order to control release of the medication, and the reservoir is filled and then closed away from the area of permeability.
• the insert can be adapted in size and shape for insertion into an opening in a cochlea to deliver a medication to the inner ear.
• the insert can be implanted into a hole drilled in bone to deliver into the medullary canal a medication or therapeutic, including a gene- therapeutic agent.
• an insert can be implanted into a hole drilled into the skull to deliver neurological medications to the brain.
• an insert can be anchored at a surgical opening to deliver a medication such as an antibiotic directly to a surgical site.
• the inserts may also be implanted within the nasal cavity.
• Such inserts may be of various shapes, sizes and first and second materials, each suitable for its particular application.
• the devices may be adapted in size and shape for veterinary applications, particularly for, though not limited to, mammals.
• the insert preferably includes a flared or barbed structure or other means for anchoring the insert in the body opening.

Applications Claiming Priority (3)

Publications (1)

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• 2005
  • 2005-07-21 WO PCT/US2005/025998 patent/WO2006014793A1/en active Application Filing
  • 2005-07-21 AU AU2005269599A patent/AU2005269599A1/en not_active Abandoned
  • 2005-07-21 CA CA002573892A patent/CA2573892A1/en not_active Abandoned
  • 2005-07-21 EP EP05773660A patent/EP1778198A1/de not_active Withdrawn

Non-Patent Citations (1)

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