Treatment of stenotic regions

• US 20040236412A1
• Filed: 05/23/2003
• Published: 11/25/2004
• Est. Priority Date: 05/23/2003
• Status: Active Grant

• Current Assignee: Balbir S. Brar, Harvinder Sahota
• Original Assignee: Balbir S. Brar, Harvinder Sahota
• Inventors: Brar, Balbir S., Sahota, Harvinder
• Granted Patent: US 7,226,473 B2
• Time in Patent Office: Days
• US Class Current: 623/1.31
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: Y10S 623/903 : Blood vessel
• CPC Class Codes: Y10S 623/921 : Blood vessel

Abstract

An improved method and devices for preventing restenosis are provided. The method may include delivering a stent configured to contain a stenosis to a body vessel. The method may also include using atherectomy at the site prior to stent delivery. In one embodiment, the stent has a proximal end, a distal end, and a center portion arranged such that the diameters of the proximal and distal ends are greater than the diameter of the center portion. In one embodiment, the atherectomy device includes a housing to prevent injury to the unaffected areas of the body vessels but the cutter is extendible beyond the housing. In one embodiment, the stent may be impregnated with at least one drug after stent deployment.

Claims

1. A stent comprising:

a tubular member having a proximal end, a distal end, and a center portion,

wherein the diameter of the proximal end and the diameter of the distal end are greater than the diameter of the center portion.

2. The stent of claim 1, wherein the stent is long enough such that the distal end and proximal end each extend about 1-6 mm beyond the stenosis.

3. The stent of claim 1, wherein the distal end and proximal end each extend about 5 mm beyond the stenosis.

4. The stent of claim 1, wherein the distal end and proximal end each extend at least 1 mm beyond the stenosis.

5. The stent of claim 1, wherein the stent is self-expanding.

6. The stent of claim 1, wherein the stent is expanded by a balloon.

7. The stent of claim 1, further comprising at least one drug.

8. The stent of claim 1, further comprising a plurality of drugs.

9. The stent of claim 8, wherein at least one of the plurality of drugs is a time-released drug.

10. The stent of claim 1, wherein the diameter of the proximal end is equal to the diameter of the distal end.

11. The stent of claim 1, wherein the diameter of the proximal end is greater than the diameter of the distal end.

12. The stent of claim 1, wherein the diameter of the distal end is greater than the diameter of the proximal end.

13. An atherectomy device, comprising:

an axially movable cutting element; and

a tubular housing surrounding said cutting element to protect undamaged vessels from the cutting element.

14. A catheter placement device comprising:

a guidewire;

a directional catheter element for directing the guidewire at a bifurcated vessel, wherein the bifurcated vessel comprises a first main vessel and a second vessel, wherein said guiding catheter element is adapted to be delivered over the guidewire and has a diameter at a first end corresponding to the first main vessel and a diameter at a second end corresponding to the second vessel, such that the guidewire is directed from the main vessel to the second vessel via the guiding catheter element; and

a balloon for stabilizing the directional catheter element at the bifurcated vessel.

15. A method of inhibiting restenosis comprising:

performing atherectomy at a vessel site; and

delivering a stent to the site,

wherein the stent comprises a tubular body having a proximal end, a center portion, and a distal end, said proximal end and distal end having a larger diameter than said center portion such that the stent contains a stenosis.

16. A method of inhibiting restenosis comprising:

delivering a stent to a treatment site; and

impregnating the stent with at least one drug at the treatment site.

17. The method of claim 16, wherein the stent is impregnated about 3-6 months after the stent is delivered to the treatment site.

18. The method of claim 16, wherein the stent has a collagen sponge to accept the drug.

19. The method of claim 16, wherein said delivering a stent and said impregnating the stent are performed with a substantial time between the two steps.

20. A drug impregnation catheter comprising:

an elongate tubular body having a proximal end and a distal end; and

a balloon attached to the distal end of the tubular body, wherein said balloon comprises at least one needle element, wherein said needle element is configured to deliver a drug to a treatment site.

21. A stent delivery catheter comprising:

an elongate tubular body having a proximal end and a distal end; and

a balloon attached to the distal end of the tubular body, wherein said balloon comprises a distal portion, a proximal portion, and a center, wherein the diameter of the proximal portion and the diameter of the distal portion are greater than the diameter of the center portion.

22. A mapping balloon catheter comprising:

an elongate catheter shaft having a distal end;

a balloon mounted on said catheter shaft, wherein said balloon is constructed of a material that is sufficiently compliant so that when pressure is applied to the inside of the balloon to inflate the balloon, the balloon conforms to a stenotic region.

23. The mapping balloon of claim 22, wherein the mapping balloon is in fluid communication with an inflation lumen in said catheter shaft, said inflation lumen carrying an inflation medium, wherein the inflation medium is radiopaque.

24. An inspection catheter for use in body lumen comprising:

an elongate catheter shaft;

a first balloon and a second balloon mounted at spaced locations along said catheter shaft;

a optical inspection element positioned on said catheter shaft between the first and second balloons.

25. The inspection catheter of claim 24, wherein said optical inspection element comprises a lens coupled to a fiber-optic in said catheter shaft.

26. The inspection catheter of claim 24, wherein said optical inspection element comprises a CCD.