Infusion catheter and methods

• US 9,352,117 B2
• Filed: 09/26/2011
• Issued: 05/31/2016
• Est. Priority Date: 10/05/2010
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: O'Day, Therese J.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/814,339
• Publication Number:
  US 20130138077A1
• Time in Patent Office: 1,709 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 25/0013 Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• 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 25/0075 Valve means
• CPC Class Codes: B26F 1/0015 specially adapted for perforating tubes
• CPC Class Codes: Y10T 83/0237 Pricking

Abstract

An infusion catheter includes an elongate catheter body having a longitudinally extending fluid supply passage, and a plurality of stellate side ports for infusing a treatment fluid from the fluid supply passage into a body lumen of a passage. Each of the stellate side ports is defined by sets of at least three convergent leaves having an attached basal edge, a terminal tip, and first and second free edges extending between the attached basal edge and the terminal tip. Making an infusion catheter includes forming a plurality of stellate side ports in fluid communication with a fluid supply passage of an elongate catheter body, each of the stellate side ports being defined by a set of at least three convergent leaves, and setting an infusion length of the infusion catheter during the forming step via spacing the stellate side ports between proximal and distal ends of the elongate catheter body.

Claims

1. An infusion catheter comprising:

an elongate catheter body including an outer body surface, and an inner body surface defining a fluid supply passage extending longitudinally between a proximal body segment having an inlet to the fluid supply passage, and a distal body segment;

a plurality of stellate side ports in fluid communication with the fluid supply passage and having a distribution within the distal body segment which defines a catheter infusion length;

each of the stellate side ports being defined by sets of at least three convergent leaves formed integrally with the elongate catheter body, and each of the convergent leaves having an attached basal edge, a terminal tip, and first and second free edges extending between the attached basal edge and the terminal tip;

the distal body segment terminating in a wire guide opening; and

wherein the infusion catheter has an infusion configuration in which the stellate side ports are open to fluid flow therethrough and the wire guide opening is obstructed to fluid flow therethrough.

2. The infusion catheter of claim 1 wherein each of the stellate side ports includes slits radiating outward from a center port axis, and each of the convergent leaves adjoins two of the slits and includes a taper narrowing toward the corresponding center port axis.

3. The infusion catheter of claim 2 wherein the stellate side ports are open in a rest state.

4. The infusion catheter of claim 2 wherein each of the stellate side ports is radially symmetric and axially asymmetric.

5. The infusion catheter of claim 4 wherein:

each of the convergent leaves defines a triangular shape in a projection plane intersecting and oriented normal to the corresponding center port axis, and curves inwardly from the outer body surface such that the terminal tip is incident to an outward flow of fluid from the fluid supply passage; and

each of the convergent leaves defines a curve in a section plane which includes a plane of the corresponding center port axis, and the curve having a shallower incipient segment and a steeper terminal segment.

6. The infusion catheter of claim 2 wherein the attached basal edge of each one of the convergent leaves defines one edge of a pyramidal polyhedron, and wherein each of the adjoining slits defines one edge of the corresponding pyramidal polyhedron.

7. The infusion catheter of claim 6 wherein a number of the stellate side ports is equal to ten or greater, and wherein the stellate side ports are positioned at a plurality of different radial locations about a longitudinal center axis of the fluid supply passage.

8. The infusion catheter of claim 7 wherein the distal body segment includes a distal tip, and the wire guide opening is a gated wire guide opening formed in the distal tip and communicating with the fluid supply passage, and a plurality of deformable flaps configured to open and close the gated wire guide opening in response to inserting and removing a wire guide through the gated wire guide opening, respectively.

9. A method of making an infusion catheter comprising the steps of:

forming a plurality of stellate side ports in fluid communication with a fluid supply passage in an elongate catheter body, each of the stellate side ports being defined by a set of at least three convergent leaves; and

setting an infusion length of the infusion catheter during the forming step at least in part by spacing the stellate side ports longitudinally between proximal and distal ends of the elongate catheter body.

10. The method of claim 9 wherein the step of forming further includes simultaneously cutting the convergent leaves of each set from material of the elongate catheter body.

11. The method of claim 10 wherein the step of forming further includes forming each of the stellate side ports without removing the material of the elongate catheter body.

12. The method of claim 10 wherein cutting the convergent leaves further includes passing a pyramidal tip of a piercing tool through a body wall of the elongate catheter body.

13. The method of claim 12 wherein cutting the convergent leaves further includes stopping the pyramidal tip at a partial insertion depth within the body wall, and withdrawing the piercing tool from the partial insertion depth.

14. The method of claim 9 further including a step of forming a gated opening in the distal end of the elongate catheter body, for passing the infusion catheter over a wire guide.

15. A method of supplying a treatment fluid into a body lumen of a patient comprising the steps of:

conveying treatment fluid through a longitudinally extending fluid supply passage in an elongate catheter body of an infusion catheter;

infusing the treatment fluid from the elongate catheter body into the body lumen; and

controlling an infusion flow of the treatment fluid at least in part by obstructing a wire guide opening trough a distal tip of the infusion catheter and passing the treatment fluid through a plurality of stellate side ports defined by sets of at least three convergent leaves and fluidly connecting the fluid supply passage with the body lumen.

16. The method of claim 15 wherein the step of controlling further includes limiting distal attenuation of an infusion rate via throttling a flow of the treatment fluid with the stellate side ports.

17. The method of claim 16 wherein the step of controlling further includes limiting the distal attenuation via a non-uniform longitudinal distribution pattern of the stellate side ports.

18. The method of claim 16 wherein passing the treatment fluid further includes passing the treatment fluid through at least three radiating slits of each one of the stellate side ports.

19. The method of claim 18 wherein passing the treatment fluid further includes passing the treatment fluid about sets of at least three convergent leaves defining each of the stellate side ports and having terminal leaf tips positioned incident to a flow of the treatment fluid.

20. The method of claim 16 further comprising the steps of positioning the infusion catheter at a treatment location within the body lumen at least in part by sliding the elongate catheter body over a wire guide passing through a distal opening to the fluid supply passage, and then removing the wire guide from the opening.

21. The method of claim 20 further comprising the steps of elevating fluid pressure within the fluid supply passage in response to throttling the flow of treatment fluid, and blocking the opening after removing the wire guide by way of a plurality of deformable flaps having a closing bias which is insensitive to the elevated fluid pressure.