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

• US 10,065,016 B2
• Filed: 01/21/2015
• Issued: 09/04/2018
• 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, Sama, Blake
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US14/601,596
• Publication Number:
  US 20150133887A1
• Time in Patent Office: 1,322 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
• 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 convection-enhanced delivery device comprising a distal portion with a first diameter, an intermediate portion with a second diameter that is greater than the first diameter, a proximal portion with a third diameter that is greater than the second diameter, and a fluid lumen extending through the distal, intermediate, and proximal portions into tissue to compress tissue against a distal-facing surface of the intermediate portion and a distal-facing surface of the proximal portion, wherein the distal-facing surfaces of the intermediate and proximal portions are perpendicular to a central axis of the delivery device;

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

wherein the delivery device includes a first tissue receiving space located adjacent to the distal-facing surface of the intermediate portion into which tissue is compressed during advancement of the delivery device; and

wherein the delivery device includes a second tissue receiving space into which tissue is compressed during advancement of the delivery device, the second tissue receiving space being located adjacent to the distal-facing surface of the proximal portion.

2. The method of claim 1, further comprising delivering a sealing gel through the fluid lumen, before delivering the fluid containing the therapeutic agent, to fill one or more voids that exist between the delivery device and tissue.

3. The method of claim 1, wherein advancing the delivery device comprises urging a nose portion of the delivery device into contact with tissue, the nose portion extending between the proximal portion of the delivery device and a proximal catheter body such that the nose portion tapers from a reduced distal diameter corresponding to an outside diameter of the proximal portion of the delivery device to an enlarged proximal diameter corresponding to an outside diameter of the catheter body.

4. The method of claim 1, wherein the delivery device is coupled to a distal end of a flexible catheter and wherein the method further comprises:

inserting the catheter through an incision;

positioning the fluid lumen in proximity to the portion of tissue using stereotactic targeting;

removing a stylet inserted through the catheter;

tunneling a proximal end of the catheter beneath a scalp of the patient; and

coupling one or more proximal fluid connectors of the catheter to a fluid delivery system.

5. The method of claim 1, wherein the tissue comprises brain tissue.

6. A method of delivering a therapeutic agent to a patient, comprising:

advancing a convection-enhanced delivery device comprising a distal cylindrical portion with a first diameter, an intermediate cylindrical portion with a second diameter that is greater than the first diameter, a proximal cylindrical portion with a third diameter that is greater than the second diameter, and a fluid lumen extending through the distal, intermediate, and proximal portions into tissue to compress tissue against a distal-facing surface of the intermediate portion and a distal-facing surface of the proximal portion;

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

wherein the delivery device includes a first tissue receiving space located adjacent to the distal-facing surface of the intermediate portion into which tissue is compressed during advancement of the delivery device; and

wherein the delivery device includes a second tissue receiving space into which tissue is compressed during advancement of the delivery device, the second tissue receiving space being located adjacent to the distal-facing surface of the proximal portion.