SYSTEMS AND METHODS FOR SHUNTING FLUID

• US 20170189656A1
• Filed: 03/17/2017
• Published: 07/06/2017
• Est. Priority Date: 01/22/2013
• Status: Active Grant

• Current Assignee: Anuncia Medical Incorporated
• Original Assignee: Alcyone Lifesciences, Inc.
• Inventors: Anand, PJ, Brophy, Morgan, Singh, Deep Arjun, Fallon, Timothy, Degon, Robert, Attar, Matthew, Wong, Anthony, Waller, Allison, East, Andrew, McIntyre, Jon T.
• Granted Patent: US 10,639,461 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2039/0018 designed for flushing a line, e.g. by a by-pass
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/225 Flush valves, i.e. bypass valves for flushing line

Abstract

Systems and methods are provided herein that generally involve shunting fluid, e.g., shunting cerebrospinal fluid in the treatment of hydrocephalus. Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions. Catheters with built-in flow indicators are also provided. Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imageable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI, thereby providing a reliable indication as to whether the catheter is partially or completely blocked. Systems and methods for flushing a shunt system are also disclosed herein, as are various systems and methods for opening auxiliary fluid pathways through a shunt system.

Claims

1. A catheter for shunting fluid built up within a skull of a patient, comprising:

an elongate tubular body having proximal and distal ends;

first and second flexible tips extending from the distal end of the elongate body and having one or more fluid passageways extending therethrough;

a plurality of fluid ports formed in the first and second tips; and

a coupling member configured to hold the first and second tips in a position adjacent to one another.

2. The catheter of claim 1, wherein the first and second flexible tips are sized and configured for placement in a brain ventricle.

3. The catheter of claim 1, wherein the coupling member comprises a peelable sheath disposed around the first and second tips.

4. The catheter of claim 1, wherein the coupling member comprises a seamlessly removable insertion sheath disposed around the first and second tips.

5. The catheter of claim 1, wherein the coupling member comprises a bioabsorbable adhesive disposed between the first and second tips.

6. The catheter of claim 1, wherein the coupling member comprises a stylet or cannula disposed around the first and second tips.

7. The catheter of claim 1, wherein the first and second tips each have a D-shaped cross-section.

8. The catheter of claim 7, wherein the first and second tips together form a circular cross-section when coupled to one another by the coupling member.

9. The catheter of claim 1, wherein the first and second tips each have a circular cross-section.

10. The catheter of claim 1, wherein the plurality of fluid ports are formed in a helical pattern through sidewalls of the first and second tips.

11. The catheter of claim 1, wherein pulsatile flow of fluid in which the first and second tips are disposed is effective to cause the first and second tips to strike one another, thereby dislodging obstructions from the first and second tips.

12. The catheter of claim 1, further comprising a plurality of shrouds, each shroud being disposed over a respective one of the plurality of fluid ports.

13. The catheter of claim 12, wherein the plurality of shrouds are formed as hollow quarter spheres.

14. The catheter of claim 1, wherein at least one of the first and second tips includes an embedded microsensor.

15. The catheter of claim 14, wherein the embedded microsensor comprises at least one of an interrogatable sensor, a pressure sensor, a flow sensor, a tilt sensor, an accelerometer sensor, a glutamate sensor, a pH sensor, a temperature sensor, an ion concentration sensor, a carbon dioxide sensor, an oxygen sensor, and a lactate sensor.

16. The catheter of claim 14, wherein the embedded microsensor is a pressure sensor that supplies an output indicative of a pressure in the environment surrounding the first and second tips to a valve to control a fluid flow rate through the valve.

17. The catheter of claim 1, wherein at least one of the first and second tips contains a quantity of a drug, is coated with a drug, or is impregnated with a drug.

18. The catheter of claim 17, wherein the drug comprises at least one of an antibacterial agent, an anti-inflammatory agent, a corticosteroid, and dexamethasone.

19. The catheter of claim 1, wherein the first and second tips are formed from a polymeric composition.

20. A shunt for draining fluid built up within a skull of a patient, comprising:

the catheter of claim 1;

a skull anchor coupled to the proximal end of the elongate tubular body, the skull anchor including an injection port through which fluid can be supplied to or withdrawn from the elongate tubular body;

a drain catheter extending from the skull anchor; and

a one-directional, pressure-controlled valve disposed in line with at least one of the catheter and the drain catheter.

21. A method of shunting body fluid, comprising:

inserting a catheter having first and second flexible tips extending from a distal end thereof and coupled to one another into a fluid-containing cavity such that fluid can flow out of the cavity through the catheter; and

decoupling the first and second tips such that pulsatile flow of fluid within the cavity causes the first and second tips to strike one another, thereby dislodging obstructions from the first and second tips.

22. The method of claim 21, wherein said decoupling comprises at least one of removing a sheath disposed around the first and second tips, removing a stylet or cannula disposed around the first and second tips, and exposing a bioabsorbable adhesive disposed between the first and second tips to the fluid.

23. The method of claim 21, further comprising adjusting a fluid flow rate through a valve in response to an output of a pressure sensor disposed on at least one of the first and second tips.

24. A catheter, comprising:

an elongate tubular body having proximal and distal ends and a fluid lumen extending therethrough; and

a plurality of flow-indicating projections extending radially inward from an interior surface of the fluid lumen, each of the projections having an imageable portion;

wherein at least the imageable portions of the projections are configured to move relative to the fluid lumen when fluid is flowing through the fluid lumen and to remain stationary relative to the fluid lumen when fluid is not flowing through the fluid lumen.

25. The catheter of claim 24, wherein the projections each include a first end fixed to the interior surface of the fluid lumen and a second end free to move relative to the interior surface of the fluid lumen.

26. The catheter of claim 25, wherein the imageable portions are disposed at the second free ends of the projections.

27. The catheter of claim 24, wherein the projections are formed by advancing the projections through openings pierced through a sidewall of the elongate tubular body and then sealing the openings.

28. The catheter of claim 24, wherein the imageable portions are formed from a radiopaque material.

29. The catheter of claim 24, wherein the imageable portions are formed from a metallic material.

30. The catheter of claim 24, wherein the imageable portions are formed from a material that is visible under magnetic resonance imaging (MRI).

31. The catheter of claim 24, wherein the projections are flexible.

32. The catheter of claim 24, wherein the projections are disposed throughout the length of the elongate tubular body.

33. The catheter of claim 24, wherein the projections are grouped in one or more clusters formed at discrete locations within the elongate tubular body.

34. A method of determining whether fluid is flowing through a fluid lumen of an implanted catheter, comprising:

capturing one or more images of the catheter and a plurality of flow-indicating projections extending radially inward from an interior surface of the fluid lumen, each of the projections having an imageable portion;

determining that fluid is flowing through the fluid lumen when the images indicate that the imageable portions are moving relative to the fluid lumen; and

determining that fluid is not flowing through the fluid lumen when the images indicate that the imageable portions are stationary relative to the fluid lumen.

35. The method of claim 34, wherein the images are at least one of magnetic resonance images, computed tomography images, positron emission tomography images, and fluoroscopic images.

36. A catheter comprising:

an elongate body having proximal and distal ends and a plurality of independent fluid lumens extending through at least a portion thereof;

a plurality of fluid openings formed in a sidewall of the elongate body, each fluid opening being in fluid communication with one of the plurality of fluid lumens;

wherein the fluid openings are formed such that fluid openings that are in fluid communication with different ones of the plurality of independent fluid lumens face in different directions.

37. The catheter of claim 36, further comprising a conical tip formed at the distal end of the elongate body, the conical tip having a plurality of fluid openings formed therein, each of the fluid openings being in fluid communication with one or more of the plurality of fluid lumens.

38. A flusher comprising:

a body having an upstream port and a downstream port;

a flush channel extending from a ventricle channel and a drain channel to a dome, the ventricle channel extending from the upstream port to the flush channel and the drain channel extending from the downstream port to the flush channel; and

a valve disposed in the flush channel having a first position in which the ventricle channel and the drain channel are in fluid communication with one another and the dome is not in fluid communication with the ventricle channel or the drain channel via the flush channel, and a second position in which the dome is in fluid communication with the ventricle channel via the flush channel and the drain channel is not in fluid communication with the dome or the ventricle channel;

wherein the dome is collapsible to move the valve to the second position and flush fluid through the ventricle channel.

39. A flushing system, comprising:

a flush component having a collapsible dome;

a valve component coupled to the flush component by a first catheter and having a flush valve and a flapper valve disposed therein; and

a Y adapter coupled to the valve component by a second catheter and coupled to the flush component by a third catheter;

wherein the flush valve is configured to open when a pressure differential across the flush valve exceeds a predetermined threshold;

wherein the flapper valve is configured to open when the flush valve opens to block fluid flow from the valve component to the Y adapter; and

wherein the dome is collapsible to create a pressure differential across the flush valve.

40. A flusher comprising:

a body having an upstream port and a downstream port;

a ventricle channel that extends from the upstream port to a flush valve chamber;

a drain channel that extends from the downstream port to a refill valve chamber;

a flush channel that extends from the flush valve chamber to a dome;

a refill channel that extends from the refill valve chamber to the dome;

a bypass channel that extends from the flush valve chamber to the refill valve chamber;

a flush valve disposed in the flush valve chamber and configured to allow fluid communication between the flush channel and the ventricle channel when a pressure differential cross the flush valve exceeds a predetermined threshold;

a refill valve disposed in the refill valve chamber and configured to allow fluid to flow from the bypass channel into the refill channel and prevent fluid from flowing from the refill channel into the bypass channel; and

a bypass valve disposed in the bypass channel configured to prevent fluid flow through the bypass channel when the fluid pressure in the bypass channel exceeds a predetermined threshold;

wherein the dome is collapsible to force fluid through the flush valve and the ventricle channel while causing the bypass valve to close to prevent fluid from being forced through the drain channel.

41. The flusher of claim 40, further comprising a spring configured to bias the dome to an un-collapsed configuration.

42. A catheter, comprising:

a primary fluid inlet port through which fluid external to the catheter can flow into an inner lumen of the catheter;

an auxiliary fluid inlet port covered by a membrane such that fluid external to the catheter cannot flow through the auxiliary inlet port;

wherein the membrane is configured to rupture when a predetermined threshold force is applied to the membrane by fluid in the inner lumen of the catheter to open the auxiliary fluid inlet port and allow fluid to flow therethrough.

43. The catheter of claim 42, wherein the auxiliary fluid inlet port comprises a rectangular slot with rounded corners.

44. The catheter of claim 42, wherein the primary fluid inlet port includes at least one slit extending therethrough such that the periphery of the inlet port is configured to deform outwards when the catheter is flushed.