Esophageal dilation and stent delivery system and method of use

• US 20070233221A1
• Filed: 03/31/2006
• Published: 10/04/2007
• Est. Priority Date: 03/31/2006
• Status: Abandoned Application

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Raju, Gottumukkala
• Application Number:
  US11/395,727
• Publication Number:
  US 20070233221A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0067 conical
• CPC Class Codes: A61F 2250/0091 transparent or translucent

Abstract

Methods and assemblies for dilating and/or delivering a stent into a body cavity or vessel is described. The assembly is particularly suited for the dilation, delivery and fixation of a stent in a body cavity, such as in a stricture in the esophagus, and includes a guidewire, an endoscope having a dilator cap affixed to its distal end, a stent, and a flexible stent delivery device. The dilator cap can be customized to various sizes, depending upon the interior diameter of the stricture to be dilated, and can be interchanged with the other dilator caps on the distal end of the endoscope. The endoscope-dilator assembly can be slid distally down the guidewire to the stricture to be dilated, and the stent can then be delivered distally along the guidewire using a delivery device. The stent delivery device and the endoscope-dilator assembly can be retracted proximally along the guidewire through the interior of the stent, leaving the stent in place in the stricture.

Claims

1. An assembly for the delivery of a prosthesis in a body vessel or cavity of a mammal, the assembly comprising:

a guide wire;

an endoscope having a distal end and a proximal end;

a dilator cap having a distal end, a proximal end, and a tapered shape wherein the proximal end has a diameter greater than the diameter of the distal end; and

wherein the proximal end of the dilator cap is coupled to the distal end of the endoscope, and

wherein the dilator cap is transparent or translucent.

2. The assembly of claim 1, wherein the dilator cap is selected from a kit comprising a plurality of dilator caps, the plurality of dilator caps each having different proximal end diameters.

3. The assembly claim 1 further comprising a flexible stent delivery device and a stent removably coupled to the device.

4. A method for delivering a prosthesis into a body vessel or cavity of a mammal using the assembly of claim 1, the method comprising:

a) inserting a guide wire within a body vessel or cavity;

b) coupling a first dilator cap to the distal end of an endoscope to form a endoscope-dilator assembly;

c) extending the endoscope-dilator assembly through the interior of the vessel or cavity to a predetermined point so as to effectively dilate the predetermined point; and

d) withdrawing the endoscope-dilator assembly.

5. The method of claim 4, further comprising:

selecting a second dilator cap from a kit comprising a plurality of dilator caps, the second dilator cap having proximal end diameter different from the proximal end diameter of the first dilator cap;

coupling the second dilator cap to the distal end of the endoscope to form a second endoscope-dilator assembly; and

extending the second endoscope-dilator assembly through the interior of the vessel or cavity to the predetermined point.

6. An assembly for the delivery and fixation of a stent in a body vessel or cavity, the assembly comprising:

a guide wire;

an endoscope having a distal end and a proximal end;

a dilator cap having a distal end, a proximal end, and a length no more than one quarter of the length of the endoscope;

a stent; and

a flexible stent delivery device,

the dilator cap being transparent or translucent and coupled to the distal end of the endoscope.

7. The assembly of claim 6, wherein the dilator cap is selected from a kit comprising a plurality of dilator caps, the plurality of dilator caps each having different proximal end and/or distal end diameters.

8. The assembly of claim 6, wherein the stent comprises one or more apertures or rings circumferentially located on a flange of the stent.

9. A method for delivering a stent into a body vessel or cavity, the method comprising:

a) providing a stent delivery device;

b) inserting a guide wire having a distal tip and a proximal end within a body vessel or cavity until the guide wire distal tip reaches a desired location in the body vessel or cavity;

c) extending an endoscope having a dilator attached to the distal end thereof through the interior of the vessel or cavity to a predetermined point;

d) inserting a stent through the vessel or cavity to the predetermined point with a stent delivery device, the stent being slidably disposed on the endoscope;

e) withdrawing the endoscope with attached dilator and the guide wire from the body vessel or cavity; and

f) withdrawing the stent delivery device from the body vessel or cavity, wherein the method of delivering is performed independent of a stent expanding device.

10. The method of claim 9, further comprising attaching the stent to a wall of the vessel or cavity using an attachment means that is capable of passing through one or more apertures or rings in a proximal flange of the stent and into a wall of the vessel or cavity.

11. The method of claim 10, wherein the attachment means comprises a surgical suture.

12. The method of claim 9, wherein the endoscope-dilator assembly, guide wire, and stent delivery device are withdrawn simultaneously.

13. A method for delivering a stent into the esophagus of a mammal for treating esophageal strictures, the method comprising:

a) extending a guide wire into the esophagus and extending the guide wire past a stricture in the esophagus;

b) inserting an endoscope having a dilator affixed thereto into the esophagus, extending through the esophageal stricture;

c) inserting a stent into the esophagus, over the endoscope;

d) inserting the stent into the esophageal stricture using a pusher catheter; and

e) withdrawing the endoscope having the dilator affixed thereto from the stricture.

14. The method of claim 13, further comprising withdrawing the pusher catheter and the guide wire.

15. The method of claim 13, further comprising withdrawing the pusher catheter, guide wire, and endoscope having the dilator affixed thereto simultaneously.

16. The method of claim 13, further comprising attaching the stent to a wall of the vessel or cavity using an attachment means that is capable of passing through one or more apertures or rings in a proximal flange of the stent and into a wall of the vessel or cavity.

17. A kit for use in endoscopic surgery, the kit comprising:

a plurality of conically-shaped dilator caps having a distal end, a proximal end, and a tapered edge between the distal end and the proximal end,

wherein the dilators;

are translucent or transparent;

have a proximal end with a diameter ranging from about 5 mm to about 15 mm; and

have a distal end with a diameter ranging from about 2 mm to about 8 mm.

18. The kit of claim 17, wherein the dilators further comprise at least-one radio-opaque element.

19. The kit of claim 17, wherein at least one of the dilators has graduations.

20. A stent, comprising:

a distal flange;

a proximal flange;

a medial sleeve intermediate between the distal flange and the proximal flange; and

a support structure within the medial sleeve,

wherein the proximal flange comprises one or more attachment means for the attachment of the stent to a biological body.