Deflectable tip access sheath

• US 20070203474A1
• Filed: 01/04/2007
• Published: 08/30/2007
• Est. Priority Date: 01/09/2006
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Vance Products Incorporated (Cook Group Incorporated)
• Inventors: Ryan, Walter, Bunch, Tyler, Drewes, David, DeMars, Bruce, Frankland, Gregory
• Granted Patent: US 7,803,130 B2
• Time in Patent Office: Days
• US Class Current: 604/528
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00424 ergonomic, e.g. fitting in fist
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A disposable access sheath having a deflectable tip is provided. The access sheath is very flexible and allows a physician or other medical professional to provide diagnostic or therapeutic services to a remote body cavity. The access sheath has a deflectable tip that is able to bend at least 90° or 180° or more. This flexibility allows the physician or medical professional to make a very tight turn to visualize or treat the body cavity being treated. The access sheath may include a visualization system, a working channel, an irrigation channel, or other desirable features. The access sheath may include an interface at the proximal end of the working channel for insertion of an instrument for diagnosis or treatment of a human or mammalian patient.

Claims

1. An access sheath, comprising:

a proximal portion comprising at least one interface;

a distal portion adapted for bending at an angle;

an elongated portion extending from the proximal portion through the distal portion, the elongated portion comprising a working lumen and two additional lumens, one of said lumens adapted to receive an optical system; and

at least one deflector filament in at least one of said additional lumens, the at least one deflector filament operatively coupled to the distal portion and extending to the proximal portion.

2. The access sheath of claim 1, further comprising at least one connector mounted to the proximal end of the access sheath.

3. The access sheath of claim 1, wherein at least one of the lumens is formed on the inside of a coiled wire.

4. The access sheath of claim 1, further comprising a handle attached to the proximal end of the sheath, wherein an obturator is attachable to the handle.

5. The access sheath of claim 4, wherein the handle is shaped like a funnel.

6. The access sheath of claim 1, further comprising an insert for mounting to the proximal end of the access sheath, the insert comprising a connector and a mating interface.

7. The access sheath of claim 1, further comprising an insert adapted for removably clipping onto the proximal end of the access sheath.

8. The access sheath of claim 1 further comprising at least one additional lumen around the deflector wire.

9. The access sheath of claim 1, further comprising a coil around one of the lumens, and further comprising a coating on an inside of the coil.

10. The access sheath of claim 1, wherein the elongated portion further comprises a coil in compression around an inner plastic tube, the coil and plastic tube around one of the lumens.

11. The access sheath of claim 1, further comprising a control handle for connection to the at least one deflector wire, the control handle adapted for incremental movement.

12. The access sheath of claim 11, wherein the control handle further comprises an actuator.

13. The access sheath of claim 11, further comprising at least two deflector wires and an actuator assembly;

wherein the deflector wires are in communication with the actuator assembly.

14. The access sheath of claim 1, wherein the distal portion is adapted for bending at an angle of at least 180°

.

15. The access sheath of claim 1, further comprising a removable obturator extending through the distal portion.

16. An access sheath, comprising:

an elongated access sheath extending from a proximal portion to a distal portion, the proximal portion having at least one connector and an interface;

at least one coil embedded within the access sheath, the coil reinforcing at least a portion of a lumen extending from the proximal portion to the distal portion;

at least one additional lumen extending from the proximal portion to the distal portion and adapted to receive an optical system or a portion of an irrigation system; and

at least one deflector filament operatively coupled to the distal portion and extending through the access sheath, the deflector filament and access sheath adapted for bending the distal portion of the access sheath at an angle.

17. The access sheath of claim 16, wherein the distal portion is adapted for bending at an angle of at least 180°

.

18. The access sheath of claim 16, wherein the at least one coil is selected from the group consisting of a coiled wire, a braided wire, a polymeric coil and a filament-reinforced polymeric coil.

19. The access sheath of claim 16, further comprising an insert for mounting to the proximal portion of the access sheath, the insert further comprising a mating interface.

20. The access sheath of claim 16, further comprising an insert for mounting to the proximal portion of the access sheath, the insert further comprising a mating interface and a septum.

21. The access sheath of claim 16, further comprising an insert for mounting to the proximal portion of the access sheath, the insert further comprising a mating interface and at least one connector.

22. The access sheath of claim 16, further comprising a removable obturator extending through the distal portion.

23. The access sheath of claim 16, further comprising a polymeric lining between the lumen and the coil.

24. The access sheath of claim 16, further comprising a handle adapted to deflect the distal portion.

25. A method of making a deflectable tip access sheath, the method comprising:

a. forming a reinforced lumen by encapsulating a coil comprising a plurality of turns into a deflectable tip access sheath comprising a proximal portion and a distal portion;

b. forming at least one additional lumen extending from the proximal portion to the distal portion, the at least one additional lumen adapted to receive an optical system or a portion of an irrigation system; and

c. providing at least one deflector filament and operatively coupling a distal end of the deflector filament to the distal portion of the access sheath and extending a proximal end of the deflector filament to the proximal portion of the access sheath, wherein tensioning of the at least one deflector filament enables the distal portion of the access sheath to bend at an angle.

26. The method of claim 25, wherein encapsulating is accomplished by a method selected from the group consisting of molding, insert molding, fixing the coil between inner and outer tubes, adhering inner and outer tubes around the coil, extruding a polymeric material over the coil, and heat shrinking a tube around the coil.

27. The method of claim 25, further comprising forming an interface in the proximal portion of the access sheath, a proximal portion of the reinforced lumen, or a proximal portion of the at least one additional lumen.

28. The method of claim 25, further comprising forming or molding a connector to the proximal portion of the access sheath, the proximal portion of the reinforced lumen, or the proximal portion of the at least one additional lumen.

29. The method of claim 25, further comprising forming a connector for detachably mounting to the proximal portion of the access sheath.

30. A method of making an access sheath, the method comprising:

providing a first tube having at least two lumens extending therethrough wherein each lumen has an inner diameter;

providing two mandrels having an outer diameter less than the inner diameter of the lumens;

placing one of each mandrel into one of each lumen;

covering the first tube with a heat shrink tube; and

shrinking the inner diameters of the lumens to the outer diameter of the mandrels using a reflow process.

31. The method of claim 30, further comprising:

providing a wire coil having a plurality of turns; and

inserting the wire coil into a lumen.

32. The method of claim 30, further comprising:

providing a liner having an outer diameter less than the inner diameter of the lumen; and

inserting the liner into the lumen.

33. The method of claim 30, wherein the two mandrels further comprise at least three mandrels.