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

• US 9,254,202 B2
• Filed: 01/08/2013
• Issued: 02/09/2016
• Est. Priority Date: 09/20/2002
• Status: Expired due to Fees

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Diaz, Stephen Hunter, Park, Kinam
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US13/736,752
• Publication Number:
  US 20130127089A1
• Time in Patent Office: 1,127 Days
• Field of Search: 427/2.25, 623/1.15
• US Class Current: 1/1
• 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 for loading a beneficial agent into an expandable medical device. The method includes the steps of sealing a plurality of openings extending through the medical device from a first side to a second side with a sealing member to substantially prevent a beneficial agent from passing through the openings, partially filling the openings with the beneficial agent delivered from an automated micro-jetting dispenser, substantially solidifying the beneficial agent, and removing the sealing member from the plurality of openings.

Claims

1. A method for loading a beneficial agent into a medical device, the method comprising:

mounting the medical device over a mandrel, the medical device including a plurality of through-holes extending through a thickness of a wall of the medical device from a first side to a second side, the mandrel having an resilient outer jacket;

sealing one of the plurality of through-holes at the first side of the respective through-hole with the resilient outer jacket of the mandrel to substantially prevent a beneficial agent from leaking at an interface of the resilient outer jacket and the medical device to prevent the beneficial agent from passing to the first side of the respective through-hole;

at least partially filling the respective through-hole with the beneficial agent delivered from an automated micro-jetting dispenser;

substantially solidifying the beneficial agent; and

removing the resilient outer jacket of the mandrel from the respective through-hole.

2. The method of claim 1, wherein the resilient outer jacket of the mandrel is formed of a rubber-like material.

3. The method of claim 2, wherein the resilient outer jacket of the mandrel is formed of the rubber-like material, and the medical device is a stent.

4. The method of claim 1, wherein the plurality of through-holes are formed by lasercutting.

5. The method of claim 1, wherein the medical device is a metallic medical device.

6. The method of claim 1, wherein the respective through-hole has an area of at least 5×

10<sup>−

6</sup> square inches.

7. The method of claim 1, wherein the beneficial agent includes a drug and a polymer matrix.

8. The method of claim 1, wherein the step of substantially solidifying includes drying the beneficial agent.

9. The method of claim 1, wherein the micro jetting dispenser is a piezoelectric micro jetting dispenser.