BIOACTIVE ANEURYSM CLOSURE DEVICE ASSEMBLY AND KIT

• US 20010047202A1
• Filed: 07/12/1999
• Published: 11/29/2001
• Est. Priority Date: 07/12/1999
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: BARRY, JAMES J., EDER, JOSEPH C., SLAIKEU, PAUL C., ABRAMS, ROBERT M., WALLACE, MICHAEL P.
• Granted Patent: US 6,663,607 B2
• Time in Patent Office: Days
• US Class Current: 623/1.46
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof

Abstract

This is an implantable medical device assembly for use in surgical procedures. It is most preferably an implantable structure having stenting properties but only partially coated with or partially associated with a material causing a localized angiogenic response. One variation of is an artificial occlusion kit having the inventive implantable stenting structure situatable and vaso-occlusive devices. The implantable stenting structure is typically situated so to prevent migration of artificial occlusion devices or implants from an occlusion site, such as an aneurysm, and into an adjacent body space, such as a blood vessel.

Claims

1. An artificial occlusion kit for retaining an artificial occlusion device in a body space to be occluded adjacent to and extending from a body lumen in a mammal, comprising:

at least one occlusion device for filling at least a portion of the body space; and

a retaining device deliverable and implantable at a retaining site in the body lumen adjacent to the body space, said retaining device having two opposite ends and forming a first shape with a first outer diameter, said retaining device being expandable to a second shape having a second outer diameter larger than said first outer diameter and sufficient to engage a body lumen wall at the retaining site such that a barrier is formed against migration of said at least one occlusion device out of the body space and into the body lumen, said second diameter being only partially coated or associated with at least one material causing a localized angiogenic response, said second shape also forming a lumen along a longitudinal axis sufficient to allow flow of fluids therethrough.

2. The artificial occlusion kit of

claim 1

wherein said retaining device forms said first shape when constrained for delivery to the retaining site, and forms said second shape upon release from said constraint at the retaining site.

3. The artificial occlusion kit of

claim 2

further comprising

a delivery catheter having a proximal delivery catheter end with a proximal delivery port, an opposite distal delivery catheter end portion with a distal delivery port, and a delivery lumen extending between said delivery ports and having a delivery lumen inner diameter less than said second outer diameter,

wherein said retaining device is sliceable disposable under constraint within said delivery lumen.

4. The artificial occlusion kit of

claim 1

wherein said at least one occlusion device for filling at least a portion of the body space comprises one or more helically wound coil.

5. The artificial occlusion kit of

claim 1

wherein said at least one material causing local angiognic response comprises materials which increase cell attachment or thrombogenicity.

6. The artificial occlusion kit of

claim 5

wherein said materials which increase cell attachment or thrombogenicity are selected from the group consisting of collagen, fibrinogen, vitronectin, other plasma proteins, growth factors (e.g., vascular endothelial growth factor, “

vEGF”

), synthetic peptides of these and other proteins having attached RGD (arginine-glycine-aspartic acid) residues (at one or both termini), and other cell adhesion peptides.

7. The artificial occlusion kit of

claim 6

wherein said materials which increase cell attachment or thrombogenicity are cell adhesion peptides selected from the group consisting of GRGDY, oligonucleotides, full or partial DNA constructs, natural or synthetic phospholipids, and polymers with phosphorylcholine functionality.

8. The artificial occlusion kit of

claim 1

wherein said at least one angiogenic material comprises materials having polynucleotide sequences encoding peptides (e.g., genes) involved in wound healing or promoting cellular attachment.

9. The artificial occlusion kit of

claim 1

wherein said at least one angiogenic material further comprises components having a specific role selected from the group consisting of genes, growth factors, biomolecules, peptides, oligonucleotides, members of the integrin family, RGD-containing sequences, and oligopeptides

10. The artificial occlusion kit of

claim 9

wherein said components having a specific role comprises at least one oligopeptides selected from the group consisting of fibronectin, laminin, bitronectin, hyaluronic acid, silk-elastin, elastin, fibrinogen, and other basement membrane proteins with bioactive agents.

11. The artificial occlusion kit of

claim 1

wherein said at least one material further comprises components which have one or more functions, including, but not limited to, providing a therapeutic for local or blood borne delivery, or enhancing thrombosis, coagulation, or platelet activity.

12. The artificial occlusion kit of

claim 1

wherein said at least one material causing local angiognic response comprises materials one or more polymers.

13. The artificial occlusion kit of

claim 12

wherein said one or more polymers is selected from the group consisting of polyglycolic acid, polylactic acid, reconstituted collagen, poly-p-dioxanone, and their copolymers such as poly(glycolide-lactide) copolymer, poly(glycolide-trimethylene carbonate) copolymer, poly(glycolide-ε

-caprolactone) copolymer, glycolide-trimethylene carbonate triblock copolymer, and mixtures.

14. A retaining device deliverable and implantable at a retaining site in the body lumen adjacent to a body space, said retaining device having two opposite ends and forming a first shape with a first outer diameter, said retaining device being expandable to a second shape having a second outer diameter larger than said first outer diameter and sufficient to engage a body lumen wall at the retaining site such that a barrier is formed against migration of said at least one occlusion device out of the body space and into the body lumen, said second diameter being only partially coated or associated with at least one material causing a localized angiogenic response, said second shape also forming a lumen along a longitudinal axis sufficient to allow flow of fluids therethrough.

15. The retaining device of

claim 14

wherein said retaining device forms said first shape when constrained for delivery to the retaining site, and forms said second shape upon release from said constraint at the retaining site.

16. The retaining device of

claim 14

wherein said at least one material comprises materials which increase cell attachment or thrombogenicity.

17. The retaining device of

claim 14

wherein said materials which increase cell attachment or thrombogenicity are selected from the group consisting of collagen, fibrinogen, vitronectin, other plasma proteins, growth factors (e.g. vascular endothelial growth factor, “

vEGF”

), synthetic peptides of these and other proteins having attached RGD (arginine-glycine-aspartic acid) residues (at one or both termini), and other cell adhesion peptides.

18. The retaining device of

claim 17

wherein said materials which increase cell attachment or thrombogenicity are cell adhesion peptides selected from the group consisting of GRGDY, oligonucleotides, full or partial DNA constructs, natural or synthetic phospholipids, and polymers with phosphorylcholine functionality.

19. The retaining device of

claim 17

wherein said at least one material comprises materials having polynucleotide sequences encoding peptides (e.g., genes) involved in wound healing or promoting cellular attachment.

20. The retaining device of

claim 17

wherein said at least one material further comprises components having a specific role selected from the group consisting of genes, growth factors, biomolecules, peptides, oligonucleotides, members of the integrin family, RGD-containing sequences, and oligopeptides

21. The retaining device of

claim 20

wherein said components having a specific role comprises at least one oligopeptides selected from the group consisting of fibronectin, laminin, bitronectin, hyaluronic acid, silk-elastin, elastin, fibrinogen, and other basement membrane proteins with bioactive agents.

22. The retaining device of

claim 17

wherein said at least one material further comprises components which have one or more functions, including, but not limited to, providing a therapeutic for local or blood borne delivery, or enhancing thrombosis, coagulation, or platelet activity.

23. The retaining device of

claim 14

wherein said at least one material causing local angiognic response comprises materials one or more polymers.

24. The retaining device of

claim 23

wherein said one or more polymers is selected from the group consisting of polyglycolic acid, polylactic acid, reconstituted collagen, poly-p-dioxanone, and their copolymers such as poly(glycolide-lactide) copolymer, poly(glycolide-trimethylene carbonate) copolymer, poly(glycolide-ε

-caprolactone) copolymer, glycolide-trimethylene carbonate triblock copolymer, and mixtures.