Method and apparatus for loading a benefical agent into an expandable medical device

• US 20040238978A1
• Filed: 06/18/2004
• Published: 12/02/2004
• Est. Priority Date: 09/20/2002
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Diaz, Stephen Hunter
• Application Number:
  US10/871,216
• Publication Number:
  US 20040238978A1
• Time in Patent Office: Days
• US Class Current: 264/1.26
• 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

1-76. -76. (cancelled).

77. A method for ensuring accurate dispensing of a beneficial agent into an implantable medical device, the method comprising:

placing an implantable medical device having a plurality of openings on a movable support;

dispensing a beneficial agent into the plurality of openings with a dropwise dispensing device;

recording the dispensing process during dispensing with an observation system including at least one camera; and

verifying that the openings have been filled with the observation system.

78. The method of claim 77, further comprising dispensing the beneficial agent with a piezoelectric micro-jetting dispenser.

79. The method of claim 77, wherein the plurality of openings have different volumes and the amount of beneficial agent dispensed is adjusted based on the size of the opening.

80. The method of claim 77, further comprising adjusting an amount of the beneficial agent dispensed into an opening based on an amount of beneficial agent previously dispensed into the opening.

81. The method of claim 77, wherein the implantable medical device is a stent.

82. The method of claim 77, wherein the movable support is a mandrel having a resilient outer surface which seals a bottom side of the openings.

83. The method of claim 77, wherein the beneficial agent comprises a drug.

84. A method for ensuring accurate dispensing of a beneficial agent into an implantable medical device, the method comprising:

placing an implantable medical device having a plurality of openings on a movable support;

providing a central processing unit connected to a motion system for the movable support and a dispensing system;

delivering to the central processing unit a manufacturing specification for the implantable medical device including the size, shape, and arrangement of the openings;

mapping the implantable medical device on the movable support to obtain an actual specification of the medical device including locations of the openings;

combining the manufacturing specification and a plurality of coordinates from the mapping of the implantable medical device to form a specific map of the implantable medical device which is stored in the central processing unit; and

dispensing a beneficial agent into the plurality of openings in accordance with the specific map.

85. The method of claim 84, further comprising verifying that the openings have been filled with the observation system.

86. The method of claim 84, wherein the mapping is performed by a camera.

87. The method of claim 84, wherein the mapping is performed by a machine vision system.

88. The method of claim 84, further comprising an observation system for observing the dispensing of the beneficial agent into the plurality of openings.

89. The method of claim 84, further comprising verifying the dispensing of the beneficial agent into the plurality of opening of the medical device.

90. An apparatus for ensuring accurate dispensing of a beneficial agent in an implantable medical device, the apparatus comprising:

a movable support configured to receive the implantable medical device having openings;

a motion system for moving the movable support;

a camera for creating images of the implantable medical device;

a central processing unit connected to the motion system creating a specific map of the implantable medical device, wherein the central processing unit is provided with a manufacturing specification for the implantable medical device including the size, shape, and arrangement of the openings, the central processing unit controls the camera to map the implantable medical device on the movable support to obtain an actual location of the openings in the implantable medical device, and the central processing unit combines the manufacturing specification and actual location of the openings determined by mapping of the implantable medical device to create a specific map of the implantable medical device which is stored in the central processing unit; and

a dispenser configured to dispense a beneficial agent into the openings in the implantable medical device in a dropwise manner based on the specific map of the implantable medical device created by the central processing unit.

91. The apparatus of claim 90, wherein the central processing unit controls the dispensing of the beneficial agent into the openings of the implantable medical device with the dispenser.

92. The apparatus of claim 90, further comprising an observation system for verifying dispensing of the beneficial agent into the openings in the implantable medical device.

93. The apparatus of claim 92, wherein the observation system includes a monitor for observing the dispensing of the beneficial agent into the plurality of openings of the expandable medical device.

94. The apparatus of claim 90, wherein the movable support is a mandrel.

95. The apparatus of claim 94, wherein the mandrel is encapsulated with a rubber-like material.

96. The apparatus of claim 90, wherein the dispenser is a piezoelectric micro-jetting dispenser.