Expandable medical device with beneficial agent delivery mechanism

• US 7,819,912 B2
• Filed: 03/04/2003
• Issued: 10/26/2010
• Est. Priority Date: 03/30/1998
• Status: Expired due to Fees

• Current Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Inventors: Shanley, John F.
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US10/379,983
• Publication Number:
  US 20030167085A1
• Time in Patent Office: 2,793 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.2, 606/108, 606/198
• 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 plurality of elongated struts joined together to form a substantially cylindrical tube which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a plurality of reduced area ductile hinges interconnecting the plurality of elongated struts, wherein the ductile hinges have a cross sectional area smaller than a cross sectional area of the elongated struts, and the ductile hinges deform upon expansion or compression of the cylindrical device while the struts are substantially undeformed; and

a plurality of holes containing a beneficial agent formed in the elongated struts;

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

the total length of a hinge.

2. The expandable medical device according to claim 1, wherein said beneficial agent is a drug.

3. The expandable medical device according to claim 1, wherein said beneficial agent includes chemotherapy drugs.

4. The expandable medical device according to claim 1, further comprising an abrupt transition between each of the elongated beams and each of the ductile hinges.

5. The expandable medical device according to claim 1, further comprising a plurality of axial slots between adjacent elongated beams and a plurality of circumferential slots, wherein the plurality of ductile hinges are each formed between an axial slot and a circumferential slot.

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

7. The expandable medical device according to claim 1, wherein the ductile hinges are asymmetrically configured to reach a predetermined strain level upon a first percentage expansion and to reach the predetermined strain level upon a second percentage of compression, the first percentage being larger than the second percentage.

8. The expandable medical device according to claim 1, wherein the struts have a thickness of at least 0.003 inch.

9. An expandable medical device comprising:

a plurality of elongated struts joined together to form a substantially cylindrical tube which is expandable from a cylinder having a first diameter to a cylinder having a second diameter;

a plurality of reduced area ductile hinges interconnecting the plurality of elongated struts, wherein the ductile hinges deform upon expansion or compression of the cylindrical device while the struts are substantially undeformed; and

a plurality of holes containing a beneficial agent formed in the elongated struts;

wherein the ductile hinges are asymmetrically configured to reach a predetermined strain level upon a first percentage expansion and to reach a predetermined strain level upon a second percentage of compression, the first percentage being larger than the second percentage.

10. The expandable medical device according to claim 9, wherein said beneficial agent is a drug.

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

12. The expandable medical device according to claim 9, wherein the ductile hinges have a substantially constant width in a circumferential dimension 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 do not experience plastic deformation while the beams are plastically deformed.

13. The expandable medical device according to claim 9, further comprising an abrupt transition between each of the elongated beams and each of the ductile hinges.

14. The expandable medical device according to claim 9, further comprising a plurality of axial slots between adjacent elongated beams and a plurality of circumferential slots, wherein the plurality of ductile hinges are each formed between an axial slot and a circumferential slot.

15. The expandable medical device according to claim 9, wherein the elongated beams have a thickness of at least 0.002 inch.

16. The expandable medical device according to claim 9, wherein the struts have a thickness of at least 0.003 inch.