Expandable medical device with beneficial agent delivery mechanism

• US 6,562,065 B1
• Filed: 08/28/2000
• Issued: 05/13/2003
• Est. Priority Date: 03/30/1998
• Status: Expired due to Term

• Current Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Shanley, John F.
• Primary Examiner(s): Bui, Vy Q.
• Application Number:
  US09/649,217
• Time in Patent Office: 988 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.19, 623/1.2, 623/1.21, 623/1.22, 608/108, 608/191, 608/194, 608/195, 608/198, 604/96, 604/104
• US Class Current: 623/1.15
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An expandable tissue supporting device of the present invention employs ductile hinges at selected points in the expandable device. When expansion forces are applied to the device as a whole, the ductile hinges concentrate expansion stresses and strains in small well defined areas. The expandable medical device including ductile hinges provides the advantages of low expansion force requirements, relatively thick walls which are radio-opaque, improved crimping properties, high crush strength, reduced elastic recoil after implantation, and control of strain to a desired level. The expandable tissue supporting device includes a plurality of elongated beams arranged in a cylindrical device and connected together by a plurality of ductile hinges. Although many ductile hinge configurations are possible, the ductile hinges preferably have a substantially constant hinge cross sectional area which is smaller than a beam cross sectional area such that as the device is expanded from a first diameter to a second diameter, the ductile hinges experience plastic deformation while the beams are not plastically deformed.

Claims

1. An expandable medical device comprising:

a cylindrical tube; and

a plurality of axial slots formed in the cylindrical tube in a staggered arrangement to define a network of elongated struts, wherein each of the elongated struts are axially displaced from adjacent struts, the cylindrical tube being expandable or compressible from a first diameter to a second diameter; and

a plurality of ductile hinges formed between the elongated struts, the ductile hinges allowing the cylindrical tube to be expanded or compressed from the first diameter to the second diameter by deformation of the ductile hinges, wherein the ductile hinges are asymmetrically configured to reach a predetermined strain level upon a first percentage of expansion and to reach the predetermined strain level upon a second percentage of compression, the first percentage being larger than the second percentage;

wherein the elongated struts include a plurality of holes for containing a beneficial agent.

2. The expandable medical device according to claim 1, further comprising a beneficial agent disposed within the plurality of holes.

3. The expandable medical device according to claim 2, wherein said beneficial agent is a drug.

4. The expandable medical device according to claim 2, wherein said beneficial agent includes chemotherapy.

5. The expandable medical device according to claim 1, wherein the elongated beams have a thickness of at least 0.002 inch.

6. An expandable medical device comprising:

a plurality of elongated beams, the plurality of elongated beams joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, the plurality of elongated beams each having a beam width in a circumferential direction, wherein the plurality of elongated beams are undeformed during expansion from the first diameter to the second diameter; and

a plurality of ductile hinges connecting the plurality of beams together in the substantially cylindrical device, wherein the ductile hinges have a smaller cross sectional area than the struts;

wherein the elongated beams include a plurality of holes for containing a beneficial agent.

7. The expandable medical device according to claim 6, further comprising a beneficial agent disposed within the plurality of holes.

8. The expandable medical device according to claim 7, wherein said beneficial agent is a drug.

9. The expandable medical device according to claim 7, wherein said beneficial agent includes chemotherapy.

10. The expandable medical device according to claim 6, wherein the elongated beams have a thickness of at least 0.002 inch.

11. An expandable medical device comprising:

a cylindrical tube; and

a plurality of axial slots formed in the cylindrical tube in a staggered arrangement to define a network of elongated struts, wherein each of the elongated struts are axially displaced from adjacent struts, the cylindrical tube being expandable or compressible from a first diameter to a second diameter; and

a plurality of ductile hinges formed between the elongated struts, the ductile hinges allowing the cylindrical tube to be expanded or compressed from the first diameter to the second diameter by deformation of the ductile hinges, wherein the ductile hinges have a smaller cross sectional area than the struts;

wherein the elongated struts include a plurality of holes for containing a beneficial agent.

12. The expandable medical device according to claim 11, further comprising a beneficial agent disposed within the plurality of holes.

13. The expandable medical device according to claim 12, wherein said beneficial agent is a drug.

14. The expandable medical device according to claim 12, wherein said beneficial agent includes chemotherapy.

15. The expandable medical device according to claim 11, wherein the elongated beams have a thickness of at least 0.002 inch.

16. An expandable medical device comprising:

a plurality of elongated beams, the plurality of elongated beams joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, the plurality of elongated beams each having a beam width in a circumferential direction; and

a plurality of ductile hinges connecting the plurality of beams together in the substantially cylindrical device;

wherein the elongated beams include a plurality of holes for containing a beneficial agent;

wherein the ductile hinges have a substantially constant width in a circumferential direction along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the beam width such that as the device is expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the beams are not plastically deformed.