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US20080281292A1 - Retractable Injection Port - Google Patents

Retractable Injection Port Download PDF

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Publication number
US20080281292A1
US20080281292A1 US11/781,719 US78171907A US2008281292A1 US 20080281292 A1 US20080281292 A1 US 20080281292A1 US 78171907 A US78171907 A US 78171907A US 2008281292 A1 US2008281292 A1 US 2008281292A1
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US
United States
Prior art keywords
cannula
needle
orifice
disposed
port
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US11/781,719
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English (en)
Inventor
Dyson W. Hickingbotham
Robert J. Sanchez
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Alcon Research LLC
Original Assignee
Alcon Research LLC
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Filing date
Publication date
Application filed by Alcon Research LLC filed Critical Alcon Research LLC
Priority to US11/781,719 priority Critical patent/US20080281292A1/en
Assigned to ALCON MANUFACTURING, LTD. reassignment ALCON MANUFACTURING, LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HICKINGBOTHAM, DYSON W., SANCHEZ, ROBERT J.
Assigned to ALCON RESEARCH, LTD. reassignment ALCON RESEARCH, LTD. MERGER (SEE DOCUMENT FOR DETAILS). Assignors: ALCON MANUFACTURING, LTD.
Publication of US20080281292A1 publication Critical patent/US20080281292A1/en
Abandoned legal-status Critical Current

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    • A61M5/44—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 having means for cooling or heating the devices or media
    • A61M5/445—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 having means for cooling or heating the devices or media the media being heated in the reservoir, e.g. warming bloodbags
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Definitions

  • the present invention relates to a single-use medical device and more particularly to an ophthalmic drug delivery device with a retractable injection port.
  • Age related macular degeneration (ARMD), choroidal neovascularization (CNV), retinopathies (e.g., diabetic retinopathy, vitreoretinopathy), retinitis (e.g., cytomegalovirus (CMV) retinitis), uveitis, macular edema, glaucoma, and neuropathies are several examples.
  • AMD Age related macular degeneration
  • CNV choroidal neovascularization
  • retinopathies e.g., diabetic retinopathy, vitreoretinopathy
  • retinitis e.g., cytomegalovirus (CMV) retinitis
  • uveitis macular edema
  • glaucoma glaucoma
  • neuropathies are several examples.
  • the only available alternative is to pre-puncture the eye, remove the trocar, and then attempt to insert the cannula into the puncture wound.
  • This procedure introduces significant risks, including but not limited to trauma to the eye at the incision site, increased risk of post-operative infection, and loss of intra ocular tissue and fluid since the eye is a pressurized globe. In addition, this requirement adds significant time to the overall procedure.
  • phase transition or reagent/drug mixtures In addition, advances have been made in the types of drugs used to treat the above mentioned, and other eye diseases. Specifically, several developments have been made utilizing phase transition or reagent/drug mixtures.
  • a drug, or mixture is heated in a delivery device, such as a syringe with needle, and delivered to the posterior chamber of the eye in an injectable state (liquid, gel or semi-solid).
  • an injectable state liquid, gel or semi-solid
  • the drug cools and solidifies. As the solid dissolves, the drug is delivered to the eye over an extended length of time greater than standard liquid injections, thereby reducing the frequency of required treatments.
  • hypodermic needle that will be able to penetrate the eye without the need of pre-puncturing, allows for a suture-less procedure, provides insulation of the drug from the cooler temperature of the eye, and provides a means to trim a roughly spherical shaped bolus from the orifice upon drug delivery.
  • a cannula slidably disposed within a hypodermic needle could be used to provide a means to trim the deposited bolus from the cannula body.
  • the double wall layer created by the needle and the cannula could provide insulation of a melted drug from the cooler temperature of the eye.
  • the device could also be such that the needle is slidably disposed within the cannula resulting in similar benefits.
  • the present invention is a cannula, for delivering a bolus of a pharmaceutically active agent to the posterior chamber of the eye, having an orifice disposed at the distal tip.
  • the cannula is slidably disposed within a hypodermic needle. The sliding action of the cannula within the needle provides a means for trimming a formed bolus of a pharmaceutically active agent from the orifice of the cannula.
  • the double wall formed by the cannula within the needle provides insulation from the cooler temperatures within the eye to allow for the delivery of a phase transition drug formulation.
  • the present invention is a cannula, having an orifice disposed at the distal tip, and having a hypodermic needle slidably disposed within.
  • FIG. 1 is a cross sectional view of a retractable injection port according to a first embodiment of the present invention.
  • FIG. 2 is a cross sectional view of a retractable injection port according to a second embodiment of the present invention.
  • FIG. 3 is a cross sectional view of a retractable injection port according to a third embodiment of the present invention.
  • FIG. 4 is a cross sectional view of a disposable tip segment of a heated syringe that could be used in conjunction with the present invention.
  • FIG. 1 is one view of an ophthalmic medical device including a needle and a cannula according to an embodiment of the present invention.
  • medical device 10 includes cannula 12 and needle 14 .
  • Cannula 12 includes closed distal tip 16 and orifice 18 .
  • Needle 14 includes beveled tip 20 .
  • Cannula 12 is slidably disposed within needle 14 and may be fluidly connected to any appropriate mechanism for storage and delivery of a pharmaceutically active agent, such as a syringe or IV tube, but is most preferably fluidly coupled to a heated syringe as illustrated in FIG. 4 .
  • a pharmaceutically active agent typically a drug suspended in a phase transition compound, is contained within the storage and delivery mechanism.
  • the phase transition compound is in a solid or semi-solid state at lower temperatures and a liquid state at higher temperatures. Such a compound can be heated to a lower viscous liquid state and injected into the eye where it forms a bolus that erodes over time.
  • tip segment 210 includes plunger interface 420 , plunger 415 , dispensing chamber housing 425 , tip segment housing 217 , temperature control device 450 , thermal sensor 460 , needle 14 , dispensing chamber 405 , interface 530 , and tip interface connector 453 .
  • plunger interface 420 is located on one end of plunger 415 .
  • the other end of plunger 415 forms one end of dispensing chamber 405 .
  • Plunger 415 is adapted to slide within dispensing chamber 405 .
  • the outer surface of plunger 415 is fluidly sealed to the inner surface of dispensing chamber housing 425 .
  • Dispensing chamber housing 425 surrounds the dispensing chamber 405 .
  • dispensing chamber housing 425 has a cylindrical shape. As such, dispensing chamber 405 also has a cylindrical shape.
  • Needle 14 is fluidly coupled to dispensing chamber 405 .
  • a substance contained in dispensing chamber 405 can pass through needle 14 and into an eye.
  • Temperature control device 450 at least partially surrounds dispensing chamber housing 425 .
  • temperature control device 450 is adapted to heat and/or cool dispensing chamber housing 425 and any substance contained in dispensing chamber 405 .
  • Interface 530 connects temperature control device 450 with tip interface connector 453 .
  • Optional thermal sensor 460 provides temperature information to assist in controlling the operation of temperature control device 450 .
  • Thermal sensor 460 may be located near dispensing chamber housing 425 and measure a temperature near dispensing chamber housing 425 or may be located in thermal contact with dispensing chamber housing 425 , in which case it measures a temperature of dispensing chamber housing 425 .
  • Thermal sensor 460 may be any of a number of different devices that can provide temperature information.
  • thermal sensor 460 may be a thermocouple or a resistive device whose resistance varies with temperature. Thermal sensor is also electrically coupled to interface 530 or other similar interface.
  • tip segment 210 The components of tip segment 210 , including dispensing chamber housing 425 , temperature control device 450 , and plunger 415 are at least partially enclosed by tip segment housing 217 .
  • plunger 415 is sealed to the interior surface of dispensing chamber housing 425 . This seal prevents contamination of any substance contained in dispensing chamber 405 . For medical purposes, such a seal is desirable. This seal can be located at any point on plunger 415 or dispensing chamber housing 425 .
  • Cannula 12 is adapted to deliver a pharmaceutically active agent into an eye.
  • Cannula 12 may be of any commonly known configuration, and may be made from any appropriate material.
  • cannula 12 is designed such that its thermal characteristics are conducive to the particular drug delivery application. For example, when a heated drug is to be delivered, cannula 12 may be relatively short (several millimeters) in length to facilitate proper delivery of the drug due to thermal characteristics.
  • Distal tip 16 and orifice 18 of cannula 12 may be of any commonly known configuration.
  • distal tip 16 is blunt or rounded, and orifice 18 is located on a side wall 22 of cannula 20 .
  • distal tip 16 is flat, and orifice 18 is disposed at the distal tip, as shown in FIG. 2 .
  • Orifice 18 may be of any appropriate shape, but most preferably comprises a geometry conducive to producing a roughly spherical bolus of a pharmaceutically active agent.
  • Needle 14 is hollow with cannula 12 slidably disposed within. Needle 14 is adapted to deliver a pharmaceutically active agent to an eye. Needle 14 may be of any commonly known configuration, and may be made from any appropriate material, such as surgical stainless steel. Preferably, needle 14 is designed such that its thermal characteristics are conducive to the particular drug delivery application. For example, when a heated drug is to be delivered, needle 14 may be relatively short (several millimeters) in length to facilitate proper delivery of the drug due to thermal characteristics. Beveled tip 20 may be of any appropriate geometry, but is most preferably an angled cut hypodermic ground bevel.
  • cannula 12 is initially entirely disposed within needle 14 .
  • Beveled tip 20 of needle 14 is used to puncture the sclera of an eye.
  • needle 14 Once needle 14 has entered the posterior chamber of the eye, it is partially withdrawn exposing cannula 12 .
  • the pharmaceutically active agent is then expressed into the eye via orifice 18 .
  • the pharmaceutically active agent could be a heated phase transition compound, in which case a roughly spherical bolus 24 will be created at orifice 18 .
  • the double wall created by needle 14 and cannula 12 insulates the heated compound from the cooler temperatures within the eye. Once deposited in the eye, bolus 24 may then be trimmed from cannula 12 by withdrawing cannula 12 into needle 14 .
  • needle 140 which is similar to needle 14 , is slidably disposed within cannula 120 , which is similar to cannula 12 .
  • cannula 120 is initially withdrawn exposing tip 200 of needle 140 .
  • Needle 140 pierces the sclera and guides cannula 120 into the posterior chamber of the eye. Needle 140 is then withdrawn leaving cannula 120 inserted into the eye.
  • a pharmaceutically active agent is then expressed into the eye via orifice 180 which is located at distal end 160 of cannula 120 .
  • the present invention provides a cannula, for delivering a bolus of a pharmaceutically active agent to the posterior chamber of the eye, having an orifice disposed at the distal tip.
  • the cannula is slidably disposed within a hypodermic needle.
  • the sliding action of the cannula within the needle provides a means for trimming a formed bolus of a pharmaceutically active agent from the orifice of the cannula.
  • the double wall formed by the cannula within the needle provides insulation from the cooler temperatures within the eye to allow/improve the delivery of phase transition substances.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US11/781,719 2006-10-16 2007-07-23 Retractable Injection Port Abandoned US20080281292A1 (en)

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US11/781,719 US20080281292A1 (en) 2006-10-16 2007-07-23 Retractable Injection Port

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US92149906P 2006-10-16 2006-10-16
US92149706P 2006-10-16 2006-10-16
US92149806P 2006-10-16 2006-10-16
US11/781,719 US20080281292A1 (en) 2006-10-16 2007-07-23 Retractable Injection Port

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US12/444,000 Expired - Fee Related US9782541B2 (en) 2006-10-16 2007-10-01 Temperature control device and thermal sensor assembly for medical device
US12/444,011 Abandoned US20100057003A1 (en) 2006-10-16 2007-10-09 Drug Heating Cycle Limiter For Injection Device

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US12/444,011 Abandoned US20100057003A1 (en) 2006-10-16 2007-10-09 Drug Heating Cycle Limiter For Injection Device

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US (3) US20080281292A1 (fr)
EP (3) EP2197398B1 (fr)
JP (3) JP2010506676A (fr)
KR (1) KR20090081402A (fr)
AU (2) AU2007349204B2 (fr)
BR (2) BRPI0717162A2 (fr)
CA (3) CA2920921C (fr)
ES (2) ES2527295T3 (fr)
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