INTRALUMINAL DEVICES FOR THE PREVENTION AND TREATMENT OF VASCULAR DISEASE

• US 20070087028A1
• Filed: 12/05/2006
• Published: 04/19/2007
• Est. Priority Date: 04/16/1998
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Falotico, Robert, Zhao, Jonathon
• Application Number:
  US11/566,707
• Publication Number:
  US 20070087028A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/54 Chiropodists' instruments , e.g. pedicure chiropractic devices A61H1/008
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2002/91533 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 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• 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 2300/42 : Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/43 : Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/45 : Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/606 : Coatings
• CPC Class Codes: A61L 2300/61 : containing two or more active agents in different layers
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 27/12 : containing fluorine atoms

Abstract

An intralumen medical device comprising anti-inflamatory and anti-thrombotic or anti-coagulant drugs, agents or compounds may be utilized in the treatment of vascular disease. The intralumen medical device is selectively coated with the drugs, agents or compounds for local delivery, thereby increasing their effectiveness and reducing potential toxicity associated with systemic use. The selective coating is utilized to ensure that the specific drugs, agents or compounds come into contact with or are delivered to the appropriate tissues and/or fluids for maximum effectiveness.

Claims

1. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body having an inner surface facing the lumen of a blood vessel and an outer surface facing, and in an expanded state, contacting the innermost wall of a blood vessel; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the outer surface of the tubular body.

2. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body.

3. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body.

4. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the stent and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing and in an expanded state contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness.

5. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface;

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-proliferative layer.

6. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the stent and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface;

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-proliferative layer.

7. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness.

8. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface;

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-proliferative layer.

9. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface;

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-proliferative layer.

10. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the wall thickness.

11. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface; and

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the abluminal surface of the wall thickness.

12. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface;

at least one layer of one or more anti-proliferative compounds affixed only to at least a portion of the wall thickness; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-proliferative layer.

13. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body having an inner surface facing the lumen of a blood vessel and an outer surface facing, and in an expanded state, contacting the innermost wall of a blood vessel; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the outer surface of the tubular body.

14. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body.

15. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body.

16. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the stent and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing and in an expanded state contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness.

17. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface;

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-inflamatory layer.

18. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the stent and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface;

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-inflamatory layer.

19. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portion of the wall thickness.

20. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface;

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-inflamatory layer.

21. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface;

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the tubular body and at least a portionof the wall thickness; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-inflamatory layer.

22. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface and an abluminal surface, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the abluminal surface and the luminal surface; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the wall thickness.

23. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface; and

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the abluminal surface of the wall thickness.

24. An intraluminal medical device comprising:

an expandable scaffold structure having a substantially tubular body, the tubular body including one or more hoop elements configured to be the primary radial load-bearing elements of the expandable scaffold structure and one or more connector elements connecting adjacent hoop elements to form a substantially tubular structure having a luminal surface facing the lumen of a blood vessel and an abluminal surface facing, and in an expanded state, contacting the innermost wall of a blood vessel, the one or more connector elements and the one or more hoop elements having a predetermined wall thickness, wherein the wall thickness is defined by the radial distance between the luminal surface and the abluminal surface;

at least one layer of one or more anti-inflamatory compounds affixed only to at least a portion of the wall thickness; and

at least one layer of one or more anti-thrombotic compounds affixed to the at least one anti-inflamatory layer.