Stepped catheters with flow restrictors and infusion systems using the same

• US 9,539,382 B2
• Filed: 03/12/2013
• Issued: 01/10/2017
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nelson, Brian D.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US13/795,539
• Publication Number:
  US 20140276417A1
• Time in Patent Office: 1,400 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1406 Minimizing backflow along the delivery catheter track
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• 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 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A stepped catheter comprising a distal portion of smaller diameter than a proximal portion, wherein the distal portion defines a flow aperture configured to deliver fluid passing through the catheter from the proximal portion to the flow aperture. The catheter may include a flow restrictor located within a lumen of the catheter at or near the flow aperture. A filter element may also be included and located within the lumen of the catheter at a location upstream of the flow restrictor.

Claims

1. A catheter assembly, comprising:

a tubular catheter body having proximal and distal ends, the body comprising an inner surface defining a body lumen extending between the proximal and distal ends;

a tubular needle comprising a proximal portion fixed relative to the catheter body and located within the body lumen, and a protruding portion extending distally beyond the distal end of the catheter body, wherein the needle further comprises;

an outer surface having a diameter that is less than a diameter of an outer surface of the catheter body; and

an inner surface defining a needle lumen in fluid communication with the body lumen, wherein a flow aperture in fluid communication with the needle lumen is provided along the protruding portion at or near a distal end of the needle;

a flow restrictor located within the needle lumen and fixed in position relative to the needle, the flow restrictor comprising a distal end positioned at or near the flow aperture;

a filter element positioned within the body lumen at or near a proximal end of the flow restrictor; and

a tubular sleeve positioned between the flow restrictor and the filter element.

2. The catheter assembly of claim 1, further comprising a guide tube fixed to the inner surface of the catheter body near the distal end of the catheter body such that the guide tube is at least partially located within the body lumen, the guide tube comprising a distal end face positioned at or near the distal end of the catheter body, and wherein the needle is fixed to the guide tube.

3. The catheter assembly of claim 1, wherein the distal end of the needle comprises a sealed distal tip, and wherein the flow aperture is located proximate to, but offset from, the sealed distal tip.

4. The catheter assembly of claim 1, wherein the flow restrictor is fixed to the needle.

5. The catheter assembly of claim 1, wherein the flow restrictor comprises a fused silica capillary.

6. The catheter assembly of claim 5, wherein the fused silica capillary is positioned such that a distal end of the capillary is at or near, and upstream from, the flow aperture.

7. The catheter assembly of claim 1, wherein the filter element is fixed to the inner surface of the catheter body.

8. The catheter assembly of claim 1, wherein the filter element comprises sintered Titanium.

9. The catheter assembly of claim 1, wherein an upstream end of the filter element defines a counterbored well.

10. A catheter assembly, comprising:

a flexible tubular catheter body having proximal and distal ends, the body comprising an inner surface defining a body lumen extending between the proximal and distal ends;

a guide tube fixed to the inner surface of the body near the distal end of the body such that the guide tube is at least partially located within the body lumen, the guide tube comprising a distal end face positioned at or near the distal end of the body;

a tubular needle comprising a proximal portion extending along an inner surface of the guide tube, and a protruding portion extending distally beyond the distal end face of the guide tube, wherein the needle further comprises;

an outer surface having a diameter that is less than a diameter of an outer surface of the catheter body; and

an inner surface defining a needle lumen in fluid communication with the body lumen, wherein a side flow aperture in fluid communication with the needle lumen is provided along the protruding portion near a distal end of the needle, the side flow aperture defining a flow axis transverse to a longitudinal axis of the needle;

an elongate flow restrictor positioned within the needle, the flow restrictor comprising a proximal end and a distal end, the distal end located at or near the side flow aperture;

a filter element located near the proximal end of the flow restrictor within the body lumen; and

a tubular sleeve positioned between the flow restrictor and the filter element.

11. The catheter assembly of claim 10, wherein the flow restrictor is fixed to one or both of the guide tube and the needle.

12. The catheter assembly of claim 10, wherein the filter element is fixed to the catheter body.

13. The catheter assembly of claim 10, wherein the flow restrictor comprises a fused silica capillary.

14. The catheter assembly of claim 10, wherein the filter element is spaced-apart from the flow restrictor.

15. An infusion catheter system comprising:

a first therapy catheter comprising a proximal end and a distal end, wherein the first therapy catheter defines a first lumen extending from the proximal end of the first therapy catheter to a flow aperture through which fluid flowing distally through the first lumen of the first therapy catheter from the proximal end exits the first therapy catheter;

a second therapy catheter comprising a proximal end and a distal end, wherein the second therapy catheter comprises a second lumen extending from the proximal end of the second therapy catheter to a flow aperture through which fluid flowing distally through the second lumen from the proximal end of the second therapy catheter exits the second therapy catheter;

a flow splitter comprising;

a supply port;

a first exit port in fluid communication with the first lumen of the first therapy catheter; and

a second exit port in fluid communication with the second lumen of the second therapy catheter, wherein fluid entering the flow splitter through the supply port exits the flow splitter through either the first exit port or the second exit port;

a first flow restrictor located within the first lumen near the flow aperture of the first therapy catheter such that the fluid flowing through the first exit port into the first lumen passes through the first flow restrictor;

a second flow restrictor located within the second lumen near the flow aperture of the second therapy catheter such that the fluid flowing through the second exit port into the second lumen passes through the second flow restrictor;

a first filter element positioned within the first lumen between the proximal end of the first therapy catheter and the first flow restrictor;

a second filter element positioned within the second lumen between the proximal end of the second therapy catheter and the second flow restrictor;

a first tubular sleeve positioned between the first flow restrictor and the first filter element;

a second tubular sleeve positioned between the second flow restrictor and the second filter element; and

a burr hole anchor configured to secure to tissue at a cranial burr hole, wherein the anchor is configured to receive and immobilize the first therapy catheter as it passes through the burr hole.

16. The system of claim 15, further comprising a second burr hole anchor configured to secure to the tissue at a second burr hole, wherein the second anchor is configured to receive and immobilize the second therapy catheter as it passes through the second burr hole.

17. The system of claim 15, further comprising an infusion pump fluidly coupled to the supply port of the flow splitter such that fluid contained within the pump is deliverable to the flow apertures of the first and second therapy catheters.

18. The system of claim 15, wherein one or both of the first filter element and the second filter element comprises an elongate cylinder having first and second ends, and wherein one or both of the first filter element and the second filter element is counterbored from each of the first and second ends to form first and second wells, respectively.

19. The system of claim 15, wherein the distal ends of one or both of the first and second therapy catheters comprises a reduced diameter portion.

20. The system of claim 19, wherein one or both of the first and second flow restrictors are positioned within the reduced diameter portion of the first and second therapy catheters, respectively.

21. The system of claim 15, wherein the first and second flow restrictors comprise first and second capillary tubes, respectively.

22. The system of claim 21, wherein the first capillary tube and the second capillary tube are flow-matched capillary tubes.