Balloon catheter sheath

• US 20050159645A1
• Filed: 11/12/2004
• Published: 07/21/2005
• Est. Priority Date: 11/12/2003
• Status: Abandoned Application

• Current Assignee: Endoscopic Technologies Incorporated (Atricure, Inc.)
• Original Assignee: Endoscopic Technologies Incorporated (Atricure, Inc.)
• Inventors: Bertolero, Arthur A., Ibrahim, Tamer
• Application Number:
  US10/988,025
• Publication Number:
  US 20050159645A1
• Time in Patent Office: Days
• US Class Current: 600/116
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• CPC Class Codes: A61B 1/00148 using anchoring means
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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

Abstract

Apparatus and method for using disposable jackets or sheaths with many kinds of surgical devices, such as catheters and endoscopes. An inflatable balloon is mounted on an outside surface of the sheath. The sheath may also include radiopaque markers, a sterility strip, one or more attachment clips, adhesive attachment, an endcap, and/or an inflation lumen formed as a tube that extends beyond the proximal end of the sheath. The balloons of the sheath may have regular or irregular profiles and shapes, including but not limited to: a bowtie shape, a donut shape, helix, spiral, alternating on opposing sides. The balloon may be simultaneously inflated through a common lumen or they may separately inflatable through separate lumens.

Claims

1. A sheath for use with a medical device during a medical procedure, the sheath comprising:

an elongated body having a proximal end and a distal end,

a main lumen extending through said elongated body from said proximal end to said distal end, said main lumen sized and configured to allow insertion of a medical instrument therethrough,

and an inflatable balloon mounted on an outside surface of said elongated body proximate said distal end.

2. The sheath of claim 1, used in combination with said medical instrument, wherein said medical instrument is an endoscope, and wherein said main lumen is sized to allow said endoscope to fit therein.

3. The sheath of claim 2, further comprising an inflation lumen located within said endoscope, said inflation lumen having a distal end connectable with said inflatable balloon and a proximal end connectable with a source of inflation solution.

4. The sheath of claim 1, used in combination with said medical instrument, wherein said medical instrument is a catheter, and wherein said main lumen is sized to allow said catheter to fit therein.

5. The sheath of claim 1, further comprising an inflation lumen extending from said proximal end of said elongated body to said inflatable balloon.

6. The sheath of claim 1, further comprising an adhesive located within the main lumen.

7. The sheath of claim 1, further comprising an endcap covering the distal end of the main lumen.

8. The sheath of claim 1, further comprising a frangible region forming a portion of said elongated body.

9. The sheath of claim 8, wherein said frangible region is a circumferential line around said elongated body.

10. The sheath of claim 8, wherein said frangible region is along a longitudinal axis of said elongated body.

11. The sheath of claim 1, further comprising a clip sized and configured to hold said sheath to the medical instrument.

12. The sheath of claim 11, wherein a proximal end of said inflation lumen is formed by a tube extending beyond said proximal end of said elongated body.

13. The sheath of claim 1, wherein said balloon has an irregular profile.

14. The sheath of claim 13, wherein said profile has a depression forming the balloon into a bowtie shape.

15. The sheath of claim 1, further comprising a plurality of additional inflation balloons and wherein said inflation balloons are located along a length of said elongated body.

16. The sheath of claim 15, wherein said inflatable balloons are alternately located on opposite sides of said elongated body.

17. The sheath of claim 1, further comprising a plurality of additional inflation balloons and wherein said inflation balloons are donut shaped and located in spaced apart relation along a length of said elongated body.

18. The sheath of claim 1, further comprising a second inflatable balloon and wherein said inflatable balloons are independently inflatable.

19. The sheath of claim 1, further comprising a second inflatable balloon and wherein said inflatable balloons have different shapes.

20. The sheath of claim 1, wherein said main lumen is expandable.

21. A sheath for use with a medical device during a medical procedure, the sheath comprising:

an elongated body having a proximal end and a distal end,

a main lumen extending through said elongated body from said proximal end to said distal end, said main lumen sized and configured to allow insertion of a medical instrument therethrough,

an inflatable balloon mounted on an outside surface of said elongated body proximate said distal end,

an inflation lumen extending from said proximal end to said inflatable balloon,

a bendable region of said elongated body, said bendable region being located intermediate said proximal end and said distal end,

a frangible region forming a portion of said elongated body,

a radiopaque marker located on said elongated body,

and a sterilization strip located on an exterior surface of said elongated body.

22. A method of using a balloon sheath, the method comprising the steps of:

(a) inserting a medical instrument into a main lumen of a balloon sheath;

(b) inserting the medical instrument and balloon sheath into a patient;

(c) inflating a balloon located proximate a distal end of the sheath;

(d) performing a surgical procedure with the medical instrument.

23. The method of claim 22, further comprising the step of:

(e) irrigating the end of the medical instrument by passing irrigation fluid through an irrigation lumen of said balloon sheath and over an end of the sheath.

24. The method of claim 23, further comprising the step of;

(f) withdrawing the majority of the irrigation fluid through a suction lumen of said balloon sheath.

25. The method of claim 22, wherein performing step (c) is used to steer the sheath.

26. The method of claim 22, further comprising the step of:

(e) inserting an additional medical instrument into the main lumen.

27. The method of claim 26, wherein the main lumen is expanded in order to perform step (e).

28. The method of claim 22, further comprising the step of removing the sheath from the medical instrument by tearing the sheath along a frangible region.

29. The method of claim 22, further comprising the step of shortening the sheath by tearing the sheath around a frangible line.