METHOD AND APPARATUS FOR LOADING A BENEFICIAL AGENT INTO AN EXPANDABLE MEDICAL DEVICE

• US 20110017346A1
• Filed: 07/22/2010
• Published: 01/27/2011
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Inventors: PARK, Kinam, DIAZ, Stephen Hunter
• Granted Patent: US 8,349,390 B2
• Time in Patent Office: Days
• US Class Current: 141/2
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B01D 1/18 to obtain dry solids B01D1/24 takes precedence

Abstract

The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a mandrel, the medical device forming a cylindrical device having a plurality of openings and dispensing a beneficial agent into the plurality of openings.

Claims

1-57. -57. (canceled)

58. An apparatus for loading a beneficial agent in a medical device having a plurality of openings, the apparatus comprising:

a dispenser configured to dispense a beneficial agent into the plurality of openings in the medical device;

an observation system configured to locate and identify the plurality of openings; and

a central processing unit for controlling the dispensing of the beneficial agent into the openings of the medical device, wherein an amount and location of droplets of beneficial agent dispensed into each of the openings in the medical device is determined by the central processing unit based on information obtained from the observation system.

59. The apparatus of claim 58, further comprising a mandrel for mounting a plurality of medical devices.

60. The apparatus of claim 59, wherein the mandrel includes a resilient outer surface which seals a bottom side of the opening.

61. The apparatus of claim 58, wherein the plurality of openings have different volumes and the amount of beneficial agent dispensed is adjusted based on the volume of the opening.

62. The apparatus of claim 58, wherein the beneficial agent comprises a drug.

63-70. -70. (canceled)

71. A system for controlling a delivery of a beneficial agent into an opening, the system comprising:

a mandrel having a plurality of expandable medical devices;

a dispenser configured to dispense a first layer and a second layer of a beneficial agent into a plurality of openings in the expandable medical device; and

a central processing unit for controlling the dispensing of the beneficial agent into the openings of the expandable medical device.

72. The system of claim 71, wherein the mandrel includes a resilient outer surface which seals a bottom side of the opening.

73. The system of claim 71, wherein the plurality of opening have different volumes and the amount of beneficial agent dispensed is adjusted based on the volume of the opening.

74. The system of claim 71, wherein the beneficial agent comprises a drug.

75. A method of removing stents from a mandrel, the method comprising:

radially expanding the stents by injecting air into at least a portion of the mandrel to inflate the mandrel and expand the stents;

deflating the mandrel; and

sliding the expanded stents off the mandrel.

76. The method claim 75, wherein the stents are radially constrained by a die during the inflation of the mandrel to prevent over expansion.