Method for treating tracheo-esophageal fistulas

• US 6,248,058 B1
• Filed: 04/05/1999
• Issued: 06/19/2001
• Est. Priority Date: 12/11/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Enteric Medical Technologies, Inc. (Boston Scientific Corporation)
• Inventors: Stein, Alan, Silverman, David E.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/286,531
• Time in Patent Office: 806 Days
• Field of Search: 600/29, 606/198
• US Class Current: 600/29
• CPC Class Codes: A61B 1/00133 Drive units for endoscopic tools inserted through or with the endoscope
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

Abstract

A method for treating a tracheo-esophageal fistula. The method comprises the steps of augmenting the wall forming the esophagus in the vicinity of the fistula and placing a stent over the fistula in the esophagus so as to inhibit material traveling down the esophagus from passing into the trachea. The augmenting of the wall facilitates support of the stent in the esophagus so as to enhance isolation of the fistula.

Claims

1. A method for treating a tracheo-esophageal fistula in a body of a mammal having a trachea and an esophagus each extending from a mouth wherein the fistula extends through a wall forming the esophagus into the trachea comprising the steps of augmenting the wall in the vicinity of the fistula and placing a stent over the fistula in the esophagus so as to inhibit material traveling down the esophagus from passing into the trachea, the augmenting of the wall facilitating support of the stent in the esophagus so as to enhance isolation of the fistula.

2. The method of claim 1 wherein the augmenting step includes the step of introducing at least one nonaqueous solution into the wall in the vicinity of the fistula and forming from the at least one nonaqueous solution a nonbiodegradable solid in the wall.

3. The method of claim 2 wherein the at least one solution is a solution of a biocompatible polymer and a biocompatible solvent an wherein the forming step includes the step of precipitatig the biocompatible polymer from the solution so that the biocompatible polymer solidifies in the wall so as to augment the wall and the biocompatible solvent disperses in the body.

4. The method of claim 3 wherein the solution of the biocompatible polymer and the biocompatible solvent has a composition comprising from about 2.5 to about 8.0 weight percent of a biocompatible polymer, from about 10 to about 40 weight percent of water insoluble biocompatible contrast agent and from about 52 to about 87.5 weight percent of a biocompatible solvent.

5. The method of claim 3 wherein the solution of the biocompatible polymer and the biocompatible solvent has a composition comprising from about 2.5 to about 8.0 weight percent of a biocompatible polymer, from about 10 to about 40 weight percent of a water soluble biocompatible contrast agent and from about 52 to about 87.5 weight percent of a biocompatible solvent.

6. The method of claim 3 wherein the introducing step includes the steps of extending a needle into the wall and supplying the biocompatible polymer and the biocompatible solvent through the needle into the wall.

7. The method of claim 2 wherein the forming step includes the step of forming a plurality of discrete nonbiodegradable solids in the wall.

8. The method of claim 2 wherein the forming step includes the step of forming a plurality of discrete nonbiodegradable solids in the wall disposed substantially in a plane extending perpendicularly to a centerline of the esophagus.

9. The method of claim 8 wherein the plane is disposed above the fistula.

10. The method of claim 8 wherein the plane is disposed below the fistula.

11. The method of claim 10 further comprising the step of forming a plurality of discrete nonbiodegradable solids in the wall disposed substantially in an additional plane extending perpendicularly to the centerline, the additional plane being disposed above the fistula.

12. The method of claim 8 wherein the plurality of discrete nonbiodegradable solids are disposed around the periphery of the esophagus.

13. The method of claim 1 wherein the mammal is a human.

14. The method of claim 1 wherein the placing step includes the step of placing a stent having first and second enlarged end portions in the esophagus, the first and second enlarged end portions facilitating retention of the stent in the esophagus.

15. A method for treating a tracheo-esophageal fistula in a body of a mammal having a trachea and an esophagus each extending from a mouth wherein the fistula extends through a wall forming the esophagus into the trachea comprising the steps of forming at least one implant in the wall in the vicinity of the fistula so as to add bulk to the wall and placing a stent over the fistula in the esophagus so as to inhibit material traveling down the esophagus from passing into the trachea, the bulking of the wall facilitating support of the stent in the esophagus and thereby enhancing isolation of the fistula.

16. The method of claim 15 wherein the forming step includes the step of forming at least one nonbiodegradable implant in the wall.

17. The method of claim 15 wherein the forming step includes the step of introducing at least one nonaqueous solution into the wall.

18. The method of claim 15 wherein the placing step includes the step of placing the stent over the implant.

19. A method for treating a tracheo-esophageal fistula in a body of a mammal having a trachea and an esophagus each extending from a mouth wherein the fistula extends through a wall forming the esophagus into the trachea comprising the steps of forming at least one nonbiodegradable implant in the wall in the vicinity of the fistula so as to add bulk to the wall and placing a stent in the esophagus over the at least one implant and the fistula so as to inhibit material traveling down the esophagus from passing into the trachea, the bulking of the wall facilitating support of the stent in the esophagus and thereby enhancing isolation of the fistula.

20. The method of claim 19 wherein the at least one implant is a nonbiodegradable insert.