CA2499107A1 - Multi-pressure biocompatible agent delivery device and method - Google Patents

Multi-pressure biocompatible agent delivery device and method Download PDF

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Publication number
CA2499107A1
CA2499107A1 CA002499107A CA2499107A CA2499107A1 CA 2499107 A1 CA2499107 A1 CA 2499107A1 CA 002499107 A CA002499107 A CA 002499107A CA 2499107 A CA2499107 A CA 2499107A CA 2499107 A1 CA2499107 A1 CA 2499107A1
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CA
Canada
Prior art keywords
biocompatible agent
medical gas
biocompatible
agent
pressure
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Granted
Application number
CA002499107A
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French (fr)
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CA2499107C (en
Inventor
John M. Kirwan
Joseph Jeffrey Kablik
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Genzyme Corp
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Individual
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Publication of CA2499107A1 publication Critical patent/CA2499107A1/en
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Publication of CA2499107C publication Critical patent/CA2499107C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B7/00Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas
    • B05B7/02Spray pistols; Apparatus for discharge
    • B05B7/12Spray pistols; Apparatus for discharge designed to control volume of flow, e.g. with adjustable passages
    • B05B7/1209Spray pistols; Apparatus for discharge designed to control volume of flow, e.g. with adjustable passages the controlling means for each liquid or other fluent material being manual and interdependent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B7/00Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas
    • B05B7/24Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas with means, e.g. a container, for supplying liquid or other fluent material to a discharge device
    • B05B7/2402Apparatus to be carried on or by a person, e.g. by hand; Apparatus comprising containers fixed to the discharge device
    • B05B7/2405Apparatus to be carried on or by a person, e.g. by hand; Apparatus comprising containers fixed to the discharge device using an atomising fluid as carrying fluid for feeding, e.g. by suction or pressure, a carried liquid from the container to the nozzle
    • B05B7/2435Apparatus to be carried on or by a person, e.g. by hand; Apparatus comprising containers fixed to the discharge device using an atomising fluid as carrying fluid for feeding, e.g. by suction or pressure, a carried liquid from the container to the nozzle the carried liquid and the main stream of atomising fluid being brought together by parallel conduits placed one inside the other
    • B05B7/2437Apparatus to be carried on or by a person, e.g. by hand; Apparatus comprising containers fixed to the discharge device using an atomising fluid as carrying fluid for feeding, e.g. by suction or pressure, a carried liquid from the container to the nozzle the carried liquid and the main stream of atomising fluid being brought together by parallel conduits placed one inside the other and a secondary stream of atomising fluid being brought together in the container or putting the carried fluid under pressure in the container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B7/00Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas
    • B05B7/24Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas with means, e.g. a container, for supplying liquid or other fluent material to a discharge device
    • B05B7/2402Apparatus to be carried on or by a person, e.g. by hand; Apparatus comprising containers fixed to the discharge device
    • B05B7/2472Apparatus to be carried on or by a person, e.g. by hand; Apparatus comprising containers fixed to the discharge device comprising several containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05CAPPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C17/00Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces
    • B05C17/005Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes
    • B05C17/00553Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes with means allowing the stock of material to consist of at least two different components
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05CAPPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C17/00Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces
    • B05C17/005Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes
    • B05C17/015Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes with pneumatically or hydraulically actuated piston or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • A61B2017/00495Surgical glue applicators for two-component glue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00544Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated pneumatically
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05CAPPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C17/00Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces
    • B05C17/002Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces with feed system for supplying material from an external source; Supply controls therefor

Abstract

A device for application of material to a surface, for example, biocompatible material to a tissue surface in a medical or clinical setting, is adapted to receive one or more biocompatible materials and one or more sources of pressurized medical gas, and to deliver these biocompatible materials via the medical gas(es) to a tissue surface or other surface. A regulation system controls flow of medical gas at a variety of pressures, and flow of biocompatible agent or agents, allowing agents to be sprayed or otherwise deployed onto a tissue surface. Switching apparatus operably connected to the regulation system directs a set of preset treatment positions allowing sequential application of biocompatible materials under various conditions in conjunction with an overall treatment protocol. The device can be used to apply a photoinitiating primer and polymeric sealant to a tissue surface, followed by light activation to form a polymer coating on the surface. The device can easily be operated in a variety of orientations by a user, with switching apparatus arranged for logical, stepwise progression through the protocol in any orientation.

Claims (56)

  1. Claims A device constructed and arranged for application of a biocompatible agent to a surface, comprising a regulation system switchable between a first position arranged to direct delivery of a biocompatible agent to the surface via a medical gas at a first medical gas pressure, and a second position arranged to direct delivery of the biocompatible agent to the surface via a medical gas at a second medical gas pressure.
  2. 2. A device as in claim 1, further comprising a first biocompatible agent conduit connectible to a source of a first biocompatible agent, the conduit including a first biocompatible agent outlet adapted to emit the first biocompatible agent for delivery to the surface, and a gas conduit connectable to a source of a pressurized medical gas and having an outlet adapted to emit pressurized medical gas in an orientation carrying the first biocompatible agent from the first biocompatible agent outlet to the surface.
  3. 3. A device as in claim 2, further comprising a second biocompatible agent conduit connectable to a source of a second biocompatible agent, the second conduit including a second biocompatible agent outlet adapted to emit the second biocompatible agent, wherein the second biocompatible agent outlet is positioned to emit the second biocompatible agent in relation to a pressurized medical gas outlet in an orientation carrying the second biocompatible agent from the second biocompatible agent outlet to the surface.
  4. 4. A device as in claim 3, comprising a regulation system having a preset high-flow treatment position arranged to direct delivery of the first biocompatible agent to the surface via a medical gas at a high medical gas pressure, and a preset low-flow treatment position arranged to direct delivery of the second biocompatible agent to the surface via a medical gas at a low medical gas pressure.
  5. 5. A device as in claim 2, comprising a regulation system having a first preset treatment position arranged to direct delivery of the first biocompatible agent to the surface via a medical gas at the first medical gas pressure, and a second preset treatment position arranged to direct delivery of the first biocompatible agent to the surface via a medical gas at a second medical gas pressure.
  6. 6. A device as in claim 5, constructed and arranged such that at the first medical gas pressure the first biocompatible agent is sprayed onto the surface, and at the second medical gas pressure the first biocompatible agent is expelled onto the surface without spraying.
  7. 7. A device as in claim 4, further comprising a material-free preset treatment position arranged to direct delivery of the medical gas to the surface in the absence of any biocompatible agent.
  8. 8. A device as in claim 4, wherein each of the first and second biocompatible agents is deliverable via an outlet surrounded by a flowing stream of the medical gas positioned to deliver the first or second biocompatible agent, respectively, to the surface.
  9. 9. A device as in claim 3, comprising a regulation system having a first preset treatment position arranged to direct delivery of the first biocompatible agent to the surface via a medical gas at a first medical gas pressure, and a second preset treatment position arranged to direct delivery of the medical gas to the surface in the absence of any biocompatible agent.
  10. 10. A device as in claim 9, the regulation system further including a third preset treatment position arranged to direct delivery of the second biocompatible agent to the surface via a medical gas at the first medical gas pressure.
  11. 11. A device as in claim 10, the regulation system further including a fourth preset treatment position arranged to deliver the second biocompatible material to the surface via a medical gas at a second medical gas pressure which is lower than the first pressure.
  12. 12. A device as in claim 11, the regulation system further including a default position arranged to expel medical gas in the vicinity of the first and second biocompatible agent outlets in the absence of delivery of any biocompatible agent.
  13. 13. A device as in claim 12, wherein the regulation system includes at least one switch, operable by a user of the device, each switch biased such that in the absence of its activation by a user of the device the regulation system is set at the default position.
  14. 14. A device as in claim 13, constructed and arranged to deliver each of the first and second biocompatible agents to the surface via a single medical gas which also is expelled from the device in the default position.
  15. 15. A device as in claim 14, wherein the regulation system includes switching apparatus operable by a user of the device, interconnected such that when the device is activated in a preset treatment position, at least one other preset treatment position is inactivatible.
  16. 16. A device as in claim 15, wherein the switching apparatus is interconnected such that in the first preset treatment position the second preset treatment position is inactivatible and vice versa, and in the third preset treatment position the fourth preset treatment position is inactivatible and vice versa.
  17. 17. A device as in claim 3, comprising at least two ports connectible to at least two separate reservoirs of biocompatible agent, each port fluidly connected to a conduit including a biocompatible agent outlet adapted to emit biocompatible agent in an orientation allowing medical gas emitted from the outlet of a gas conduit to carry biocompatible agent to the surface.
  18. 18. A device as in claim 3, further comprising at least two separate reservoirs of biocompatible agent, and at least two ports connectible to the at least two separate reservoirs of biocompatible agent, each port fluidly connected to a separate biocompatible agent conduit including a separate outlet.
  19. 19. A device as in claim 18, wherein each of the at least two separate reservoirs is connectible to a source of pressurized medical gas.
  20. 20. A device as in claim 18, wherein each of the at least two separate reservoirs is connectible to the source of pressurized medical gas to which the gas conduit is connectible.
  21. 21. A device as in claim 20, further comprising a source of medical gas at a pressure greater than atmospheric pressure, connected to the gas conduit and connected to the at least two separate reservoirs.
  22. 22. A device as in claim 1, further comprising at least one reservoir of biocompatible agent.
  23. 23. A device as in claim 18, wherein the at least two separate reservoirs contain at least two agents that, when provided in combination, can form a medically-acceptable coating on a tissue surface of a patient.
  24. 24. A device as in claim 23, wherein at least one of the at least two agents comprises a synthetic polymer.
  25. 25. A device as in claim 23, wherein each of the at least two agents comprises a synthetic polymer.
  26. 26. A device as in claim 23, wherein each of the at least two agents consists essentially of a synthetic polymer.
  27. 27. A device as in claim 23, wherein the at least two agents comprise a first biocompatible agent that is a photoinitiator, and a second biocompatible agent.
  28. 28. A device as in claim 27, wherein the second biocompatible agent is polymerizable upon activation by the photoinitiator.
  29. 39. A device as in claim 23, comprising a first biocompatible agent inlet port and a second biocompatible agent inlet port connectible, respectively, to a first detachable biocompatible agent reservoir and a second detachable biocompatible agent reservoir.
  30. 30. A device as in claim 29, wherein each of the first and second biocompatible agent reservoir comprises a syringe housing.
  31. 31. A device as in claim 1, further comprising an emitter of energy mounted so as to direct energy at biocompatible agent delivered from the device onto the surface.
  32. 32. A system comprising the device of claim 1 and, in combination, a separate emitter of energy able to direct energy at biocompatible agent delivered from the device onto the tissue surface, the emitter of energy separate from the device.
  33. 33. A device as in claim 1, comprising:
    a housing with a proximal portion for manipulation of the device by a user, a distal portion for delivery of biocompatible agent to the surface, and a central axis along a proximal/distal line, the proximal portion comprising switching apparatus external to the housing, operable by a user of the device and including at least three switch positions corresponding to at least three settings of the regulation system, wherein switching between any of the at least three switch positions does not result in a change in any switch position along an axis perpendicular to the central axis.
  34. 34. A device as in claim 33, wherein the switching apparatus includes at least four switch positions corresponding to at least four settings of the regulation system, and switching between any of the at least four switch positions does not result in a change in any switch position along an axis perpendicular to the central axis.
  35. 35. A device as in claim 33, wherein the switching apparatus includes at least five switch positions corresponding to at least five settings of the regulation system, and switching between any of the at least five switch positions does not result in a change in any switch position along an axis perpendicular to the central axis.
  36. 36. A device as in claim 33, the switching apparatus falling within a plane whereupon switching between any of the at least three switch positions does not result in movement of any of the switching apparatus relative to the plane.
  37. 37. A device as in claim 1, comprising:

    a shaft having a proximal portion that is inflexible under conditions of use, and a distal portion that is inelasticly flexible under conditions of use, an inlet associated with the proximal portion connectable to at least one source of biocompatible agent, an outlet associated with the distal portion for release of the biocompatible agent, and a conduit connecting the proximal portion to the outlet.
  38. 38. A device as in claim 1, further comprising a pressure regulator connectable to a source of a medical gas, the regulator having a preset, non-adjustable pressure setting, and a valued, quick-release connector constructed to receive a medical gas line connectable to a device for delivery of the medical gas in a clinical setting.
  39. 39. A device as in claim 1, constructed and arranged to be held by a user of the device in at least two, opposite orientations.
  40. 40. A device as in claim 1, comprising:
    a housing having a proximal portion for manipulation of the device by a user and a distal portion for delivery of at least a first and a second biocompatible agent to a tissue surface;
    a medical gas inlet associated with the proximal portion, connectable to a source of a medical gas;
    an outlet region associated with the distal portion for delivery of the first and second biocompatible agents to the tissue surface via the medical gas;
    a first biocompatible agent conduit connectable to a source of a first biocompatible agent and fluidly connected to the outlet region;
    a second biocompatible agent conduit fluidly connectable to a source of a second biocompatible agent and fluidly connected to the outlet region;
    a medical gas conduit system connecting the medical gas inlet to the outlet region, and fluidly connectable to the first biocompatible agent source and the second biocompatible agent source for pressurization of each, respectively, and including a first, high-pressure conduit region and a second, low-pressure conduit region directly connected to the outlet region; and a regulation system connected to the high-pressure gas conduit region and the first and second biocompatible agent conduits, switchable by a user of the device between a series of preset treatment positions arranged to direct delivery of either the first or second biocompatible agent to the tissue surface from the outlet region via the medical gas, at at least two different preset gas pressures.
  41. 41. A device as in claim 38, wherein the regulation system includes a first preset treatment position arranged to direct delivery of the first biocompatible agent through the outlet region to the tissue surface via medical gas at a first gas pressure; a second preset treatment position arranged to direct delivery of medical gas, absent any biocompatible material, from the outlet region at the first gas pressure; a third preset treatment position arranged to direct delivery of the second biocompatible agent to the tissue surface from the outlet region at the first gas pressure; and a fourth preset treatment position arranged to direct delivery of the second biocompatible agent to the tissue surface from the outlet region at a second gas pressure lower than the first gas pressure.
  42. 42. A device as in claim 41, wherein the first medical gas pressure is selected so as to spray the first or second biocompatible agent to the tissue surface, and the second medical gas pressure is selected so as to expel the second biocompatible agent onto the tissue surface without spraying.
  43. 43. A device as in claim 42, wherein the first medical gas pressure is at least 30 psi, and the second medical gas pressure is no more than 20 psi.
  44. 44. A device as in claim 42, wherein the first medical gas pressure is at least 35 psi, and the second medical gas pressure is no more than 15.
  45. 45. A device constructed and arranged for application of biocompatible agent to a surface, comprising:
    a housing with a proximal portion for manipulation of the device by a user, a distal portion for delivery of biocompatible agent to the surface, and a central axis along a proximal/distal line, the proximal portion comprising switching apparatus external to the housing, operable by a user of the device and including at least three switch positions corresponding to at least three settings of a regulation system associated with the device constructed and arranged for control of delivery of the biocompatible agent to the surface, wherein switching between any of the at least three switch positions does not result in a change in any switch position along an axis perpendicular to the central axis.
  46. 46. A device as in claim 45, wherein the switching apparatus includes at least four switch positions corresponding to at least four settings of the regulation system, and switching between any of the at least four switch positions does not result in a change in any switch position along an axis perpendicular to the central axis.
  47. 47. A device as in claim 45, wherein the switching apparatus includes at least five switch positions corresponding to at least five settings of the regulation system, and switching between any of the at least five switch positions does not result in a change in any switch position along an axis perpendicular to the central axis.
  48. 48. A device as in claim 45, the switching apparatus falling within a plane whereupon switching between any of the at least three switch positions does not result in movement of any of the switching apparatus relative to the plane.
  49. 49. A device constructed and arranged for application of one or more biocompatible agents to a surface, comprising:
    apparatus constructed and arranged to deliver at least a first biocompatible agent to the surface; and a regulation system having at least a first medical gas pressure setting and a second medical gas pressure setting lower than the first pressure setting, able to deliver medical gas to the surface at at least the first pressure and the second pressure, the regulation system including at least one preset treatment position delivering the medical gas to the surface at the first pressure in the absence of biocompatible agent.
  50. 50. A device constructed and arranged for application of biocompatible agent, comprising:
    a shaft having a proximal portion that is inflexible under conditions of use, and a distal portion that is inelasticly flexible under conditions of use, an inlet associated with the proximal portion connectable to at least one source of biocompatible agent, an outlet associated with the distal portion for release of the biocompatible agent, and a conduit connecting the proximal portion to the outlet.
  51. 51. Apparatus comprising:
    a device constructed and arranged for delivery of a biocompatible material to a tissue surface via pressurized medical gas in a clinical setting;
    a pressure regulator adapted to receive a pressurized medical gas, the regulator having a pre-set, non-adjustable pressure setting; and a valued, quick-release connector associated with the regulator, constructed to receive a medical gas line connectable to the device.
  52. 52. A device constructed and arranged for application of a biocompatible agent to a surface, comprising a regulation system switchable to a preset treatment position arranged to direct delivery of a biocompatible agent to the surface via a medical gas at a gas pressure of less than 20 psi.
  53. 53. A device as in claim 52, wherein the pressure is selected to deliver the biocompatible agent to the surface without spraying the agent onto the surface.
  54. 54. A device as in claim 52, wherein the pressure is less than 15 psi.
  55. 55. A method comprising:
    applying a biocompatible agent to a tissue surface by spraying the agent onto the surface via a medical gas pressurized at a first preset gas pressure; and applying the biocompatible agent to the tissue surface by spraying the agent via a medical gas pressurized at a second preset gas pressure lower than the first pressure.
  56. 56. A method comprising:
    applying a first biocompatible agent to a tissue surface directing a medical gas, absent any biocompatible agent, at the first biocompatible agent on the surface for a period of time sufficient to alter the first biocompatible agent at the tissue surface; and spraying a second biocompatible agent onto the tissue surface.
CA2499107A 2002-09-20 2003-06-30 Multi-pressure biocompatible agent delivery device and method Expired - Lifetime CA2499107C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/251,618 2002-09-20
US10/251,618 US7217254B2 (en) 2002-09-20 2002-09-20 Multi-pressure biocompatible agent delivery device and method
PCT/US2003/020698 WO2004026145A2 (en) 2002-09-20 2003-06-30 Multi-pressure biocompatible agent delivery device and method

Publications (2)

Publication Number Publication Date
CA2499107A1 true CA2499107A1 (en) 2004-04-01
CA2499107C CA2499107C (en) 2010-12-07

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CA2499107A Expired - Lifetime CA2499107C (en) 2002-09-20 2003-06-30 Multi-pressure biocompatible agent delivery device and method

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US (1) US7217254B2 (en)
EP (1) EP1538990B1 (en)
JP (1) JP2006500100A (en)
AT (1) ATE432653T1 (en)
AU (1) AU2003247666A1 (en)
CA (1) CA2499107C (en)
DE (1) DE60327860D1 (en)
WO (1) WO2004026145A2 (en)

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US7217254B2 (en) 2007-05-15
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