SYSTEMS AND METHODS FOR REDUCING OR PREVENTING BACKFLOW IN A DELIVERY SYSTEM

• US 20140171760A1
• Filed: 12/18/2013
• Published: 06/19/2014
• Est. Priority Date: 12/18/2012
• Status: Active Grant

• Current Assignee: Alcyone Therapeutics, Inc.
• Original Assignee: Alcyone Lifesciences, Inc.
• Inventors: Singh, Deep Arjun, Anand, PJ
• Granted Patent: US 8,992,458 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: B29C 33/0061 characterised by the configuration of the material feeding channel sprue channels for injection moulding B29C45/27
• CPC Class Codes: B29C 33/12 with incorporated means for positioning inserts, e.g. labels positioning reinforcements B29C70/541
• CPC Class Codes: B29C 39/10 incorporating preformed parts or layers, e.g. casting around inserts or for coating articles coating a surface by casting in general B05D1/30, B29C39/126 takes precedence

Abstract

Systems and methods are disclosed herein that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Claims

1. A convection-enhanced-delivery (CED) device, comprising:

a micro-tip having a proximal portion, a central portion, a distal portion, and at least one fluid channel extending along said proximal, central, and distal portions, the at least one fluid channel having an outlet port at a distal end thereof and an inlet port at a proximal end thereof;

a first outer sheath disposed coaxially over the distal portion of the micro-tip such that the distal portion of the micro-tip protrudes from a distal end of the first outer sheath;

a first tissue-receiving space defined between an exterior surface of the micro-tip and an interior surface of the distal end of the first outer sheath;

a catheter body extending proximally from the micro-tip such that the at least one fluid channel of the micro-tip is in fluid communication with a respective inner lumen of the catheter body; and

a nose portion disposed over at least the central portion of the micro-tip and extending between the first outer sheath and the catheter body such that the nose portion defines an exterior surface that tapers from a reduced distal diameter corresponding to the outside diameter of the first outer sheath to an enlarged proximal diameter corresponding to the outside diameter of the catheter body.

2. The device of claim 1, wherein the tissue-receiving space is configured to compress tissue received therein as the device is advanced through the tissue.

3. The device of claim 2, wherein tissue compressed by the tissue-receiving space forms a seal that reduces proximal backflow of fluid ejected from the outlet port of the at least one fluid channel beyond the tissue-receiving space.

4. The device of claim 1, further comprising a second outer sheath disposed over the first outer sheath such that a second tissue-receiving space is defined between an exterior surface of the first outer sheath and an interior surface of a distal end of the second outer sheath.

5. The device of claim 1, wherein the interior surface of the distal end of the first outer sheath is shaped to compress tissue received therein as the device is advanced through the tissue.

6. The device of claim 5, wherein the interior surface of the distal end of the first outer sheath is conical.

7. The device of claim 5, wherein the interior surface of the distal end of the first outer sheath is convex.

8. The device of claim 5, wherein the interior surface of the distal end of the first outer sheath is concave.

9. The device of claim 1, wherein an inside diameter of the distal end of the first outer sheath is about 1 μ

m to about 200 μ

m greater than an outside diameter of the distal portion of the micro-tip.

10. The device of claim 1, wherein an inside diameter of the distal end of the first outer sheath is about 10 percent to about 100 percent greater than an outside diameter of the distal portion of the micro-tip.

11. The device of claim 1, wherein the first outer sheath has a circular outside cross-section.

12. The device of claim 1, wherein the at least one fluid channel is formed from at least one of a parylene composition, a silastic composition, a polyurethane composition, and a PTFE composition.

13. The device of claim 1, further comprising a fluid reservoir in fluid communication with the inner lumen of the catheter body and configured to supply a fluid thereto under positive pressure.

14. The device of claim 1, wherein the micro-tip is flexible.

15. The device of claim 1, wherein the micro-tip includes an embedded microsensor.

16. The device of claim 15, wherein the embedded microsensor comprises at least one of an interrogatable sensor, a pressure 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.

17. The device of claim 1, wherein the distal end of the micro-tip has an atraumatic shape configured to penetrate tissue without causing trauma.

18. The device of claim 1, wherein the micro-tip contains a quantity of a drug, is coated with a drug, or is impregnated with a drug.

19. The device of claim 1, wherein the drug comprises at least one of an antibacterial agent, an anti-inflammatory agent, a corticosteroid, and dexamethasone.

20. The device of claim 1, wherein the micro-tip comprises a substrate having the at least one fluid channel formed thereon.

21. The device of claim 20, wherein the substrate has a rectangular transverse cross-section.

22. The device of claim 1, wherein the catheter body is formed from a rigid material and each inner lumen of the catheter body is defined by a sleeve formed from a flexible material.

23. The device of claim 22, wherein the catheter body is formed from at least one of ceramic, PEEK, and polyurethane and wherein each sleeve is formed from at least one of polyimide, pebax, PEEK, polyurethane, silicone, and fused silica.

24. The device of claim 1, wherein the catheter body is formed from a flexible material.

25. A method of assembling the device of claim 1, comprising:

forming the nose portion by molding the nose portion over the first outer sheath;

inserting the micro-tip into a proximal end of the nose portion;

coupling the proximal portion of the micro-tip to the catheter body; and

injecting a flowable material through an inlet port formed in the nose portion to fill the interior of the nose portion and secure the micro-tip and catheter body to the nose portion.

28. The device of claim 24, wherein the device is transparent to allow UV light to pass therethrough to cure mold fluid disposed within the mold cavity.

29. The device of claim 24, wherein the mold cavity is sized and configured to form a bullet nose portion over the micro-tip and over at least a portion of an outer sheath received in the mold cavity.

26. A convection-enhanced-delivery (CED) device, comprising:

a fluid conduit having proximal and distal ends;

a first outer sheath disposed coaxially over the fluid conduit such that the fluid conduit extends out of a distal end of the first outer sheath; and

a first tissue-receiving space defined between an exterior surface of the fluid conduit and an interior surface of the distal end of the first outer sheath.

27. A micro-molding device, comprising:

a mold cavity sized and configured to receive a catheter body and a catheter micro-tip therein such that at least one fluid channel of the micro-tip is at least partially disposed within a corresponding fluid line of the catheter body; and

one or more mold channels though which a mold fluid can be injected to fill the mold cavity and secure the micro-tip to the catheter body such that the at least one fluid channel of the micro-tip is in fluid communication with the at least one fluid line of the catheter body.

30-38. -38. (canceled)