Multi-pressure biocompatible agent delivery device and method

• US 20040059283A1
• Filed: 09/20/2002
• Published: 03/25/2004
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: Kirwan, John M., Kablik, Joseph Jeffrey
• Granted Patent: US 7,217,254 B2
• Time in Patent Office: Days
• US Class Current: 604/23
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: B05B 7/1209 the controlling means for each liquid or other fluent material being manual and interdependent
• CPC Class Codes: B05B 7/2437 and a secondary stream of atomising fluid being brought together in the container or putting the carried fluid under pressure in the container
• CPC Class Codes: B05B 7/2472 comprising several containers
• CPC Class Codes: B05C 17/002 with feed system for supplying material from an external source; Supply controls therefor B05C17/02 takes precedence
• CPC Class Codes: B05C 17/00553 with means allowing the stock of material to consist of at least two different components
• CPC Class Codes: B05C 17/015 with pneumatically or hydraulically actuated piston or the like B05C17/00543 takes precedence

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

30. A device as in claim 29, wherein each of the first and second biocompatible agent reservoir comprises a syringe housing.

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. 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. 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. 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. 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. 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. 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 valved, quick-release connector associated with the regulator, constructed to receive a medical gas line connectable to the device.

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. 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. A device as in claim 52, wherein the pressure is less than 15 psi.

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. 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.