Needle catheter with an angled distal tip lumen

• US 8,486,022 B2
• Filed: 07/03/2008
• Issued: 07/16/2013
• Est. Priority Date: 07/03/2008
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ludwig, Florian N., Basu, Shubhayu
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Bosques, Edelmira
• Application Number:
  US12/167,791
• Publication Number:
  US 20100004627A1
• Time in Patent Office: 1,839 Days
• Field of Search: 604192-198, 604/272, 604/164.01, 604/164.13, 604/264, 604/508
• US Class Current: 604/164.01
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• 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 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

A needle catheter configured for injecting an agent into a wall of a patient'"'"'s body cavity, which directs a needle from the distal tip of the catheter into the wall of the body cavity at an angle relative to the axis of the shaft. The resulting angled injection pathway improves the retention of the agent in the body cavity wall, while keeping a distal section of the catheter substantially perpendicular to the body cavity wall for optimal push against the tissue at the injection site.

Claims

1. An agent delivery needle catheter configured for injecting an agent at an injection site in a wall of a patient'"'"'s body cavity, comprising:

a) an elongated catheter shaft having a proximal end, a distal end, and a needle-through lumen therein extending from the proximal end to a needle-through port in a distal end face of the catheter, and the distal end face is at least in part substantially perpendicular to a longitudinal axis of a distal section of the shaft such that the distal end face and needle-through lumen port therein are configured to be pushed against the wall of the patient'"'"'s body cavity, and the needle-through lumen has an angled distal portion which extends to the needle-through port at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis; and

b) a hollow needle slidably disposed in the needle-through lumen of the shaft, having a piercing distal tip and a lumen in fluid communication with a port in the piercing distal tip, and having a retracted configuration in which the piercing distal tip of the needle is in the needle-through lumen of the shaft, and an extended configuration in which the piercing distal tip extends distally out the needle-through port, such that the catheter is configured to form an angled injection pathway in the wall of the patient'"'"'s body cavity by directing the needle into the wall of the patient'"'"'s body cavity at the angle of the angled distal portion of the needle-through lumen with the distal end face against the wall of the patient'"'"'s body cavity at the injection site.

2. The catheter of claim 1 wherein the distal end face is rounded.

3. The catheter of claim 2 wherein the shaft has a distal tip member having a distal end forming the rounded distal end face of the catheter, and a proximal end bonded to a distal end of a tubular member of the shaft, and the proximal end of the angled section of the needle-through lumen is radially aligned with or proximal to the distal tip member proximal end.

4. The catheter of claim 3 wherein the distal tip member is formed at least in part of a polymeric material having a lower Shore durometer hardness than a polymeric material forming the shaft tubular member bonded thereto.

5. The catheter of claim 1 wherein the needle-through lumen has an axially aligned portion located proximal to the angled distal portion.

6. The catheter of claim 5 wherein the axially aligned portion of the needle-through lumen is eccentrically located in the shaft, and the angled portion extends across the longitudinal axis of the shaft.

7. The catheter of claim 1 wherein the needle-through lumen extends axially aligned and eccentrically located in the shaft from the angled portion to the proximal end of the needle-through lumen.

8. The catheter of claim 1 wherein the angled portion extends helically along at least a portion of the shaft.

9. The catheter of claim 1 wherein the needle-through lumen is the single lumen of the shaft open to outside of the catheter in the distal shaft section, and the needle-through port is the single port in the distal tip section of the shaft.

10. The catheter of claim 1 wherein the needle-through lumen has a substantially uniform diameter.

11. The catheter of claim 1 wherein the angled portion extends at an angle of about 30 to about 60 degrees relative to the longitudinal axis.

12. A method of delivering an agent to an injection site in a wall of a patient'"'"'s body cavity, comprising:

a) introducing within the patient'"'"'s vasculature a catheter comprising an elongated catheter shaft having a proximal end, a distal end, and a needle-through lumen extending from the proximal end to a needle-through port in a distal end face of the catheter, and the distal end face is at least in part substantially perpendicular to a longitudinal axis of a distal section of the shaft such that the distal end face and needle-through lumen port therein are configured to be pushed against the wall of the patient'"'"'s body cavity, and the needle-through lumen has an angled distal portion which extends to the needle-through port at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis, and a hollow needle slidably disposed in the needle-through lumen of the shaft having a piercing distal tip, a lumen in fluid communication with a port in the piercing distal tip, and a retracted configuration in which the piercing distal tip is within the needle-through lumen of the catheter shaft, and percutaneously advancing the introduced catheter with the needle in the retracted configuration to position the distal end of the catheter in the patient'"'"'s body cavity;

b) pushing the distal end face against the patient'"'"'s body cavity wall at the injection site, and advancing the needle to an extended configuration in which the piercing distal tip of the needle extends distally out the port with the distal end face against the body cavity wall, such that the needle extends into the body cavity wall at the angle of the angled portion of the needle-through lumen and thereby forms an angled injection pathway in the patient'"'"'s body cavity wall; and

c) causing agent from an agent source in fluid communication with the proximal end of the needle to flow through the needle lumen, to thereby deliver the agent into the angled injection pathway in the patient'"'"'s body cavity wall.

13. The method of claim 12 wherein the needle-through lumen includes an axially aligned portion located proximal to the angled distal portion, and b) includes slidably advancing the piercing distal tip of the needle through a lumen bend to the extended configuration.

14. The method of claim 12 wherein the distal end face is rounded, and the port is pushed against the wall of the patient'"'"'s body cavity in b).

15. The method of claim 12 wherein the piercing distal tip of the needle contacts a wall which has a ramp-shape angled toward the needle-through port and which defines the needle-through lumen as the needle is distally advanced in the needle-through lumen, and is thereby directed into the angled portion of the needle-through lumen in b).

16. The method of claim 12 wherein the shaft distal shaft section is oriented substantially perpendicular to the injection site during b) and c), such that push force transmitted axially to the distal end of the catheter pushes the distal end face and port against the wall in b).

17. The method of claim 12 wherein the agent is a biomaterial comprising cells and the body cavity is a chamber of the patient'"'"'s heart, and the needle piercing distal tip is advanced into the myocardium of the patient'"'"'s heart wall in b) for agent delivery into the myocardium in c).