Systems and methods for reducing or preventing backflow in a delivery system

• US 10,363,394 B2
• Filed: 09/20/2017
• Issued: 07/30/2019
• Est. Priority Date: 12/18/2012
• Status: Active Grant

• Current Assignee: Alcyone Therapeutics, Inc.
• Original Assignee: Alcyone Lifesciences, Inc.
• Inventors: Singh, Deep Arjun, Anand, P J, Sama, Blake
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/709,657
• Publication Number:
  US 20180193595A1
• Time in Patent Office: 678 Days
• 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 method of delivering a therapeutic agent to a patient, comprising:

advancing a fluid conduit and a first outer sheath disposed therearound into tissue to compress tissue into a first tissue-receiving space defined between an exterior surface of the fluid conduit having a substantially rectangular cross-sectional shape and an interior surface of a distal end of the first outer sheath having a substantially circular cross-sectional shape; and

delivering fluid containing a therapeutic agent under positive pressure through the fluid conduit and into a portion of tissue adjacent to a distal end of the fluid conduit.

2. The method of claim 1, wherein the fluid conduit includes a substrate having one or more fluid channels formed on an outer surface of the substrate.

3. The method of claim 2, wherein the substrate is formed from silicon.

4. The method of claim 1, further comprising delivering a sealing gel through the fluid conduit, before delivering the fluid containing the therapeutic agent, to fill one or more voids that exist between the fluid conduit and the tissue adjacent to the distal end of the fluid conduit.

5. The method of claim 4, wherein the sealing gel flows back along the exterior surface of the fluid conduit.

6. The method of claim 1, wherein the tissue compressed into the first tissue-receiving space forms a seal that reduces proximal backflow of the fluid delivered through of the fluid conduit beyond the first tissue-receiving space.

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

8. The method of claim 1, wherein the interior surface of the distal end of the first outer sheath is at least one of conical, convex, and concave.

9. The method of claim 1, further comprising controlling delivery of fluid through the fluid conduit based on an output of a microsensor embedded in the fluid conduit.

10. The method of claim 1, wherein the method is used to treat at least one condition selected from central-nervous-system (CNS) neoplasm, intractable epilepsy, Parkinson'"'"'s disease, Huntington'"'"'s disease, stroke, lysosomal storage disease, chronic brain injury, Alzheimer'"'"'s disease, amyotrophic lateral sclerosis, balance disorders, hearing disorders, and cavernous malformations.

11. The method of claim 1, wherein the first outer sheath has a cylindrical outer surface.

12. The method of claim 1, wherein the first outer sheath is disposed coaxially over the fluid conduit such that the fluid conduit extends out of the distal end of the first outer sheath and wherein the first tissue-receiving space is defined by a clearance space between the exterior surface of the fluid conduit and the interior surface of the distal end of the first outer sheath.