Retrograde cardioplegia delivery catheter and method for inducing cardioplegic arrest

Patent metadata

Field	Value
Publication number	US-9314587-B2
Application number	US-201213449544-A
Country	US
Kind code	B2
Filing date	Apr 18, 2012
Priority date	Apr 18, 2012
Publication date	Apr 19, 2016
Grant date	Apr 19, 2016

Abstract

A retrograde delivery catheter includes at its distal end an expandable member configured to at least partially occlude the coronary sinus of a patient's heart, and has a length and variable stiffness that allows the distal end to be selectively articulated so as to be positioned in the coronary sinus. The delivery catheter has a triple lumen construction with a primary lumen extending between the proximal and distal ends and configured to allow a cardioplegic fluid to be delivered to the coronary sinus. A second lumen provides for balloon inflation while a third lumen allows monitoring of a pressure within the coronary sinus. A torque may be applied and a reinforcement member within the delivery catheter provides improved torque transmission along the length of the catheter.

First claim

What is claimed is:

1. A retrograde delivery catheter for retrograde delivery of a fluid into a coronary sinus, the retrograde delivery catheter comprising:
a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally through a patient such that when the proximal end is external to the patient, the distal end is positioned in the coronary sinus of the patient, the flexible, elongated shaft defining at least two lumens extending from about the proximal end toward the distal end;
an atraumatic distal tip at about the distal end of the flexible, elongated shaft;
an expandable member positioned at least proximate the distal end of the flexible, elongated shaft, the expandable member being configured to at least partially occlude the patient's coronary sinus; and
a user interface coupled to the flexible, elongated shaft, the user interface being configured to control selective articulation of the distal end of the flexible, elongated shaft, wherein the user interface defines at least one pre-set articulation position of the distal end of the flexible, elongated shaft, wherein at the at least one pre-set articulation position, the flexible, elongated shaft defines multiple sections having differing curvature radii, wherein the multiple sections are positioned in end-to-end relationship to each other along the length of the catheter, the multiple sections having differing curvature radii include at least three sections, the at least three sections each having a different durometer, wherein a first section of the three sections comprises a first section curve radius and a first section deflection, wherein a second section of the three sections comprises a second section curve radius of between 18 cm and 40 cm and a second section deflection of 10 to 20 degrees, wherein a third section of the three sections comprises a third section curve radius of between 5 and 8 cm and a third section deflection of 85 to 95 degrees, wherein the first section curve radius is larger than the second section curve radius, wherein the first section deflection is less than the second section deflection, wherein the first section is proximal to the second section along the length of the catheter, and wherein the second section is proximal of the third section along the length of the catheter.

2. The retrograde delivery catheter recited in claim 1 , wherein the flexible, elongated shaft has a predefined shape that includes an initial bend at the distal end.

3. The retrograde delivery catheter recited in claim 2 , wherein the initial bend is in a range of about 2° to about 20° relative to a longitudinal axis of a proximal portion of the flexible, elongated shaft.

4. The retrograde delivery catheter recited in claim 2 , wherein a first position of the user interface corresponds to the initial bend at the distal end of the flexible, elongated shaft.

5. The retrograde delivery catheter recited in claim 1 , wherein the user interface defines at least:
an engagement position, the engagement position corresponding to a stressed position of the user interface.

6. The retrograde delivery catheter recited in claim 1 , wherein at the at least one pre-set articulation position, the atraumatic distal tip is in a range of about 75° to about 105° relative to a longitudinal axis of a proximal portion of the flexible, elongated shaft.

7. The retrograde delivery catheter recited in claim 1 , further comprising:
a pull-wire attached to the user interface and to the flexible, elongated shaft at about the distal end of the flexible, elongated shaft.

8. The retrograde delivery catheter recited in claim 7 , wherein the pull-wire extends through a primary lumen of the at least two lumens.

9. The retrograde delivery catheter recited in claim 7 , further comprising a reinforcement member, wherein the reinforcement member and pull-wire each extend through a primary lumen of the at least two lumens.

10. The retrograde delivery catheter recited in claim 7 , wherein the pull-wire includes a jacket thereon.

11. The retrograde delivery catheter recited in claim 7 , wherein the user interface includes a multi-position switch, the multi-position switch being linked to the pull-wire.

12. The retrograde delivery catheter recited in claim 11 , wherein the multi-position switch moves at a ratio relative to movement of the pull-wire.

13. The retrograde delivery catheter recited in claim 1 , wherein the user interface includes a switch configured to at least partially control selective articulation of the distal end of the flexible, elongated shaft.

14. The retrograde delivery catheter recited in claim 13 , wherein the switch is a multi-position switch, the multi-position switch including:
a first position corresponding to an insertion position of the distal end of the flexible, elongated shaft;
a second position corresponding to an engagement position of the distal end of the flexible, elongated shaft; and
a third position corresponding to a troubleshooting position of the distal end of the flexible, elongated shaft.

15. The retrograde delivery catheter recited in claim 13 , wherein the switch is a multi-position switch, the multi-position switch including at least three positions, wherein at least one of the three positions is configured to be non-sustainable without user pressure on the switch.

16. The retrograde delivery catheter recited in claim 15 , wherein the at least three positions include first, second and third positions, wherein the third position is non-sustainable and, without user pressure, reverts to the second position.

17. The retrograde delivery catheter recited in claim 16 , wherein the first position and the second position are self-sustaining.

18. The retrograde delivery catheter recited in claim 16 , wherein a plurality of self-sustaining positions exist between the first position and the second position.

19. The retrograde delivery catheter recited in claim 1 , wherein the flexible, elongated shaft is configured to remain in-plane when selectively articulated by the user interface.

20. A retrograde delivery catheter for retrograde delivery of a fluid into a coronary sinus, the retrograde delivery catheter comprising:
an elongated shaft having a proximal end and a distal end, the elongated shaft having sufficient length and flexibility so that the elongated shaft may extend intraluminally through a patient via a peripheral blood vessel such that when the proximal end is external to the patient, the distal end is positioned in the coronary sinus of the patient, wherein a distal portion of the elongated shaft is configured to be selectively articulated between at least two pre-determined curve profiles, the elongated shaft defining at least a fluid delivery lumen and an inflation lumen and a pressure sensing lumen, wherein the fluid delivery lumen is configured to accommodate fluid flow rates of at least 100 ml/minute;
an atraumatic distal tip at the distal end of the elongated shaft, wherein the atraumatic distal tip comprises a durometer of approximately 25 Shore D;
an expandable member positioned at the distal portion of the elongated shaft proximate the atraumatic distal tip, the expandable member being inflatable to at least partially occlude the coronary sinus, wherein the inflation lumen passes along the elongated shaft from the proximal end to the expandable member and is in fluid connection with the expandable member;
a pressure port positioned on t

Assignees

• Arnim Nathan
• Hellewell Matthew
• Edwards Lifesciences Corp

Inventors

• Arnim Nathan
• Hellewell Matthew

Classifications

• A61M25/10

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title

• A61M25/0105

  Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B) · CPC title

• A61M25/0133

  Tip steering devices · CPC title

• A61M25/0026

  Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175) · CPC title

• A61M2210/125

  Heart · CPC title