Methods and Apparatus for Temporarily Occluding Body Lumens

Abstract

Methods and apparatus are provided for temporarily occluding a body lumen. A method in accordance with one or more embodiments of the invention includes introducing a tip of a catheter into the body lumen, the tip including a central longitudinal axis; expelling a thermosensitive polymer from the tip of the catheter into a portion of the body lumen, with at least a portion of the thermosensitive polymer being expelled from the tip in a direction generally radially outward from the central longitudinal axis to improve adherence of the thermosensitive polymer to a wall defining the body lumen; and at least partially withdrawing the tip from the body lumen and allowing the thermosensitive polymer to harden as it warms to body temperature to form a plug in the body lumen.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a ureter being filled percutaneously with a plug in accordance with one or more embodiments of the invention.

FIG. 2 is a cross-sectional view of a ureter fully occluded with a plug in accordance with one or more embodiments of the invention.

FIGS. 3A and 3B are cross-sectional views of a lumen illustrating the insertion of a capsule in the lumen and its subsequent formation as a plug in accordance with one or more embodiments of the invention.

FIGS. 4A and 4B are cross-sectional views of a lumen illustrating use of scaffolds with plugs in accordance with one or more embodiments of the invention.

FIG. 5 is a cross-sectional view of a lumen with a scaffold inserted therein in accordance with one or more embodiments of the invention.

FIG. 6 is a perspective view of a ureter illustrating use of a plug to form a pressurized bladder and lower ureter below the plug and unpressurized upper ureter and kidney in accordance with one or more embodiments of the invention.

FIG. 7 is a perspective view of a ureter illustrating a percutaneous stone removal procedure with the ureter plugged in accordance with one or more embodiments of the invention.

FIG. 8 is a side view of a delivery system in accordance with one or more embodiments of the invention.

FIGS. 9-13 are perspective views of various catheter tips preloaded with a gel in accordance with one or more embodiments of the invention.

FIG. 14 is a perspective view of a catheter tip preloaded with a material that can be formed into a gel in accordance with one or more embodiments of the invention.

FIGS. 15 and 16 are perspective views of catheter tips of multi-lumen catheters in accordance with one or more embodiments of the invention.

FIGS. 17A and 17B are perspective views of a catheter tip containing a movable end cap in accordance with one or more embodiments of the invention.

FIGS. 18-21B are perspective views of various catheter tips with side openings in accordance with one or more embodiments of the invention.

Claims

1. A method for temporarily occluding a body lumen, comprising the steps of: introducing a tip of a catheter into the body lumen, the tip including a central longitudinal axis;expelling a thermosensitive polymer from the tip of the catheter into a portion of the body lumen, with at least a portion of the thermosensitive polymer being expelled from the tip in a direction generally radially outward from the central longitudinal axis to improve adherence of the thermosensitive polymer to a wall defining the body lumen; andat least partially withdrawing the tip from the body lumen and allowing the thermosensitive polymer to harden as it warms to body temperature to form a plug in the body lumen.

2. The method of claim 1 wherein the thermosensitive polymer comprises a mixture of Poloxamers 338, 407, 237, or 188, or some combination thereof, and water.

3. The method of claim 1 further comprising the step of positioning a scaffolding in the body lumen, and wherein the step of expelling the thermosensitive polymer comprises expelling the thermosensitive polymer on the scaffolding.

4. The method of claim 1 wherein the step of expelling a thermosensitive polymer comprises forcing a thermosensitive polymer preloaded in the tip of the catheter out of the tip.

5. The method of claim 1 wherein the step of expelling a thermosensitive polymer comprises causing the thermosensitive polymer to traverse the length of the catheter.

6. The method of claim 1 wherein the step of expelling a thermosensitive polymer comprises expelling the thermosensitive polymer from one or more openings on a side of the tip.

7. The method of claim 1 further comprising mixing components of the thermosensitive polymer in the tip of the catheter prior to expelling the thermosensitive polymer from the tip.

8. The method of claim 1 further comprising rotating the tip while expelling the thermosensitive polymer from the tip.

9. The method of claim 1 further comprising mixing air into the thermosensitive polymer to create foam prior to expelling the thermosensitive polymer from the catheter.

10. An apparatus for temporarily occluding a body lumen, comprising: a catheter including a tip at one end thereof, the tip being insertable into the body lumen, the tip including a central longitudinal axis; anda mechanism connected to the catheter and operable by a user for expelling a thermosensitive polymer from the tip of the catheter into a portion of the body lumen;wherein the tip includes one or more openings at a side thereof to allow at least a portion of the thermosensitive polymer to be expelled from the tip in a generally radially outward direction from the central longitudinal axis to improve adherence of the thermosensitive polymer to a wall defining the body lumen, the thermosensitive polymer capable of hardening as it warms to body temperature to form a plug in the body lumen.

11. The apparatus of claim 10 wherein the thermosensitive polymer comprises a mixture of Poloxamers 338, 407, 237, or 188, or some combination thereof, and water.

12. The apparatus of claim 10 wherein the tip is preloaded with the thermosensitive polymer.

13. The apparatus of claim 12 further comprising means for inhibiting leakage of the thermosensitive polymer from the tip.

14. The apparatus of claim 10 wherein the catheter is a multi-lumen catheter, and wherein the tip includes space for allowing materials flowing separately through the multi-lumen catheter to mix prior to being expelled from the tip.

15. The apparatus of claim 14 further comprising obstructions in the space to promote mixing of the materials.

16. The apparatus of claim 10 further comprising a cap movably affixed to an end the tip of the catheter, the cap being movable toward and away from the tip to cause a thermosensitive polymer in the tip to be expelled from the tip in a direction generally perpendicular to the longitudinal axis.

17. The apparatus of claim 10 wherein the one more openings comprise a pointed slot, a rounded slot, a square slot, or a hole.

18. The apparatus of claim 10 wherein the tip includes a leading edge that is closed such that the thermosensitive polymer is expelled from the tip only through the one or more openings.

19. The apparatus of claim 10 wherein the tip includes a tapered end.

20. The apparatus of claim 10 wherein the mechanism comprises a hand-crank mechanism including a handle and a lever.

21. The apparatus of claim 10 wherein the mechanism comprises a plunger.

22. The apparatus of claim 10 wherein the catheter includes an insulating material to inhibit premature hardening of the thermosensitive polymer.

23. The apparatus of claim 10 further comprising means for mixing air into the thermosensitive polymer to create foam prior to expelling the thermosensitive polymer from the catheter.

24. An apparatus for temporarily occluding a body lumen, comprising: a catheter including a tip at one end thereof, the tip being insertable into the body lumen, the tip including a central longitudinal axis; andmeans connected to the catheter and operable by a user for expelling a thermosensitive polymer from the tip of the catheter into a portion of the body lumen such that at least a portion of the thermosensitive polymer is expelled from the tip in a direction generally radially outward from the central longitudinal axis to improve adherence of the thermosensitive polymer to a wall defining the body lumen, the thermosensitive polymer capable of hardening as it warms to body temperature to form a plug in the body lumen.