Apparatus and Method for Convection Enhanced Therapeutic Delivery

• US 20080287917A1
• Filed: 05/19/2008
• Published: 11/20/2008
• Est. Priority Date: 05/18/2007
• Status: Active Grant

• Current Assignee: Mclean Hospital (Mass General Brigham, Inc.)
• Original Assignee: Mclean Hospital (Mass General Brigham, Inc.)
• Inventors: Cunningham, Miles G.
• Granted Patent: US 8,715,240 B2
• Time in Patent Office: Days
• US Class Current: 604/523
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 2005/0612 using probes penetrating tissue; interstitial probes
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

A system for convection enhanced delivery of therapeutic comprises one or more flexible, biocompatible microcatheters that are directed to a target location to deliver a therapeutic agent. The microcatheter is releasably coupled to a guide tube and directed to the desired location. The microcatheters are small and flexible in order to reach the target areas, minimize trauma at the injection site, and minimize reflux of the injectable therapeutic.

Claims

1. An apparatus for delivering a therapeutic to a location in a body, the apparatus comprising:

a hollow guide tube comprising a lumen therethrough with distal and proximal openings, the guide tube comprising an outer diameter in a range of 0.5 to 1.2 mm;

a stylet, having proximal and distal portions, disposed within the guide tube lumen, wherein the stylet distal portion extends distally from the guide tube distal opening;

a catheter having a catheter lumen running from a distal opening to a proximal opening, the catheter lumen having a diameter in a range of 0.03 to 2.11 mm; and

a loop attached to a catheter distal portion, the loop releasably coupled to the stylet distal portion.

2. The apparatus of claim 1, wherein the loop comprises at least one of:

suture material;

stainless steel; and

a biologically inert material.

3. The apparatus of claim 1, wherein the loop is one of:

welded to the catheter;

wrapped around the catheter;

integral with the catheter; and

glued to the catheter.

4. The apparatus of claim 1, wherein:

the guide tube comprises a threaded portion; and

the stylet comprises a threaded portion,

wherein the tube threaded portion is coupled to the stylet threaded portion.

5. The apparatus of claim 1, wherein the stylet comprises at least one of:

stainless steel, platinum, cobalt, titanium, tantalum, and any alloy thereof.

6. The apparatus of claim 1, wherein the catheter comprises:

optical waveguide material to carry light energy from the proximal opening to the distal opening.

7. The apparatus of claim 1, wherein:

the guide tube comprises a first amount of flexibility; and

the catheter comprises a second amount of flexibility, wherein the catheter is significantly more flexible than the guide tube.

8. The apparatus of claim 1, further comprising:

a strain gauge, coupled to the catheter, to measure force exerted on the catheter during an insertion procedure.

9. The apparatus of claim 8, wherein:

the strain gauge is coupled to the guide tube to measure force exerted on the guide tube during the insertion procedure.

10. The apparatus of claim 9, wherein:

the strain gauge is configured to measure a difference between the force exerted on the catheter and the force exerted on the guide tube.

11. The apparatus of claim 1, wherein the stylet and the catheter are electrically coupled to one another to create a circuit, the apparatus further comprising:

a device configured to detect when the circuit is opened.

12. The apparatus of claim 1, further comprising:

a therapeutic within the catheter lumen.

13. The apparatus of claim 12, wherein the therapeutic comprises at least one of:

a gel;

a liquid;

a solid;

a gas;

a capsule; and

a powder.

14. A method of delivering a therapeutic to a target region in a body, the method comprising:

providing a hollow guide tube comprising a lumen therethrough with distal and proximal openings, the guide tube having an outer diameter in a range of 0.5 mm to 1.2 mm;

disposing a stylet, having proximal and distal portions, within the guide tube lumen, and extending the stylet distal portion distally from the guide tube distal opening;

providing a catheter having a distal portion and releasably coupling the catheter distal portion to the stylet distal portion, the catheter comprising a catheter lumen having a diameter in a range of 0.03 mm to 2.11 mm and running from a distal opening to a proximal opening;

distally inserting the releasably coupled guide tube, stylet and catheter into the body and locating the distal portion of the catheter in the target region;

withdrawing the stylet proximally through the tube and releasing the catheter from the stylet;

withdrawing the guide tube from the body and leaving the distal opening of the catheter in the target region;

coupling the catheter to a source of the therapeutic; and

delivering the therapeutic to the target region through the catheter.

15. The method of claim 14, further comprising:

attaching a loop to the catheter distal portion, and

placing the loop about the stylet distal portion,

wherein the loop comprises at least one of;

suture material;

stainless steel; and

a biologically inert material.

16. The method of claim 15, wherein attaching the loop to the catheter distal portion comprises one of:

welding the loop to the catheter;

wrapping the loop around the catheter;

integrating the loop with the catheter; and

gluing the loop to the catheter.

17. The method of claim 14, further comprising:

providing a threaded portion to the guide tube;

providing a threaded portion on the stylet; and

threading the tube threaded portion to the stylet threaded portion,

wherein withdrawing the stylet comprises;

turning the stylet to facilitate movement of the stylet threaded portion with respect to the tube threaded portion.

18. The method of claim 14, wherein the stylet comprises at least one of:

stainless steel, platinum, cobalt, titanium, tantalum, and any alloy thereof.

19. The method of claim 14, wherein the catheter comprises optical waveguide material to carry light energy from a proximal end to a distal end, the method further comprising:

applying light energy to the proximal opening of the catheter and emitting the light energy from the distal opening.

20. The method of claim 14, wherein:

the guide tube comprises a first amount of flexibility; and

the catheter comprises a second amount of flexibility,

wherein the catheter is significantly more flexible than the guide tube.

21. The method of claim 14, further comprising at least one of:

measuring force exerted on the catheter during an insertion procedure; and

measuring force exerted on the guide tube during the insertion procedure.

22. The method of claim 21, further comprising:

measuring a difference between the measured force exerted on the catheter and the measured force exerted on the guide tube.

23. The method of claim 14, further comprising:

electrically coupling the stylet and the catheter to one another to create a circuit; and

detecting when the circuit is opened.

24. The method claim 14, further comprising:

placing therapeutic within the catheter prior to insertion in the body.

25. A method of delivering a therapeutic to a target region in a body, the method comprising:

providing a catheter having a catheter lumen having a diameter in a range of 0.03 mm to 2.11 mm and running from a distal opening to a proximal opening;

disposing a stylet within the catheter lumen;

distally inserting the coupled stylet and catheter into the body and locating the distal opening of the catheter in the target region;

withdrawing the stylet proximally through the catheter and leaving the distal opening of the catheter in the target region;

coupling the catheter to a source of the therapeutic; and

delivering the therapeutic to the target region through the catheter.

26. The method of claim 25, wherein the stylet comprises at least one of:

stainless steel, platinum, cobalt, titanium, tantalum, and any alloy thereof.

27. The method of claim 25, wherein:

the stylet comprises a first amount of flexibility; and

the catheter comprises a second amount of flexibility,

wherein the catheter is significantly more flexible than the guide tube.

28. A kit for delivering a therapeutic by convection enhanced delivery to a location in a body, the kit comprising:

a hollow guide tube comprising a lumen therethrough with distal and proximal openings, wherein the guide tube has an outer diameter in a range of 0.5 mm to 1.2 mm;

a stylet, having proximal and distal portions, configured to be disposed within the guide tube lumen, wherein the stylet distal portion is configured to extend distally from the guide tube distal opening;

a catheter having a catheter lumen running from a distal opening to a proximal opening, the catheter lumen having a diameter in a range of 0.03 mm to 2.11 mm;

a loop coupled to a distal portion of the catheter and configured to be releasably coupled to the stylet distal portion; and

instructions for using the hollow guide tube, stylet, and catheter to deliver a therapeutic by convection enhanced delivery by;

disposing the stylet within the guide tube lumen, and extending the stylet distal portion distally from the guide tube distal opening;

releasably coupling the loop on the catheter distal portion to the stylet distal portion;

distally inserting the releasably coupled tube, stylet and catheter into the body and locating the distal portion of the catheter in a target region;

withdrawing the stylet proximally through the tube and releasing the catheter from the stylet;

withdrawing the guide tube from the body and leaving the catheter distal opening in the target region;

coupling the catheter to a source of the therapeutic; and

delivering the therapeutic to the target region through the catheter.

29. The kit of claim 28, wherein the loop comprises at least one of:

suture material;

stainless steel; and

a biologically inert material.

30. The kit of claim 28, wherein the loop is one of:

welded to the catheter;

wrapped around the catheter;

integral with the catheter; and

glued to the catheter.

31. The kit of claim 28, wherein:

the guide tube comprises a threaded portion; and

the stylet comprises a threaded portion,

wherein the tube threaded portion is configured to be coupled to the stylet threaded portion.

32. The kit of claim 28, wherein the stylet comprises at least one of:

stainless steel, platinum, cobalt, titanium, tantalum, and any alloy thereof.

33. The kit of claim 28, wherein:

the guide tube comprises a first amount of flexibility; and

the catheter comprises a second amount of flexibility,

wherein the catheter is significantly more flexible than the guide tube.

34. The kit of claim 28, further comprising:

a strain gauge configured to be coupled to the catheter to measure force exerted on the catheter during an insertion procedure.

35. The kit of claim 34, wherein:

the strain gauge is further configured to be coupled to the guide tube to measure force exerted on the guide tube during the insertion procedure.

36. The kit of claim 35, wherein:

the strain gauge is further configured to measure a difference between the force exerted on the catheter and the force exerted on the guide tube.

37. The kit of claim 28, wherein:

the stylet and the catheter are configured to be electrically coupled to one another to create a circuit, the kit further comprising;

a device configured to detect when the circuit is opened.

38. A kit for delivering a therapeutic by convection enhanced delivery to a location in a body, the kit comprising:

a catheter having a catheter lumen running from a distal opening to a proximal opening, the catheter lumen having a diameter in a range of 0.03 mm to 2.11 mm;

a stylet, having proximal and distal portions, configured to be disposed within the catheter lumen; and

instructions for using the stylet and catheter to deliver a therapeutic by convection enhanced delivery by;

disposing the stylet within the catheter lumen;

distally inserting the stylet and catheter into the body and locating the distal opening of the catheter in a target region;

withdrawing the stylet proximally through the catheter lumen and leaving the catheter distal opening in the target region;

coupling the catheter to a source of the therapeutic; and

delivering the therapeutic to the target region through the catheter.

39. The kit of claim 38, wherein the stylet comprises at least one of:

stainless steel, platinum, cobalt, titanium, tantalum, and any alloy thereof.