Removable stylet for retrograde cardioplegia catheter and methods for use

• US 5,226,427 A
• Filed: 06/04/1991
• Issued: 07/13/1993
• Est. Priority Date: 04/28/1988
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Research Medical, Inc. (Edwards Lifesciences Corporation)
• Original Assignee: Research Medical, Inc. (Baxter International Inc.)
• Inventors: Buckberg, Gerald D., McRea, James C., Todd, Robert J.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Lewis, Ralph A.
• Application Number:
  US07/710,720
• Time in Patent Office: 770 Days
• Field of Search: 128/10, 128/11, 128/207.29, 128/657, 128/772, 604/95, 604/170, 604/280
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

This invention relates to a stylet for use with a retrograde cardioplegia catheter and its methods of use. The stylet includes a stylet rod, a handle on the proximal end of the stylet rod and a predetermined curve in the distal end of the stylet rod. The handle has a thumb rest on the proximal end and a one or two finger loops extending outward from the handle. An obturator is located on the distal end of the predetermined curve to impede blood flow through a tip of the cardioplegia catheter during insertion of the catheter. The invention also contemplates methods for using the stylet.

Claims

1. A removable stylet for use in a retrograde cardioplegia catheter during insertion of the retrograde cardioplegia catheter into the coronary sinus of the heart, the stylet comprising:

(a) a stylet rod constructed of a substantially rigid material such that the stylet can impart the shape thereof upon a flexible cannula during insertion into the coronary sinus of a patient, the stylet rod having a predetermined curve at a distal end of the stylet body;

(b) a handle located at the proximal end of the stylet rod, the handle comprising;

(i) a handle body;

(ii) thumb rest means located at a proximal end of the handle body for securely supporting the thumb of a user; and

(iii) finger placement means, extending outwardly from a position on the handle body distal of the thumb rest means, for supporting at least one finger in order to allow manipulation of the stylet within the heart of a patient.

2. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 1, wherein the finger placement means comprises a substantially rigid wire formed into a loop.

3. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 2, wherein the loop extends outward from the handle in the same general direction as the predetermined curve.

4. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 3, wherein the loop is configured so as to support both the middle and ring fingers.

5. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 1, wherein the cardioplegia catheter with which the stylet is to be used includes an inflatable balloon, and wherein the stylet further comprises an obturator extending from a distal end of the predetermined curve, the obturator being of sufficient diameter to impede the flow of cardioplegic solution into the inflatable balloon of the cardioplegia catheter.

6. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 2, wherein the handle further comprises a second finger placement means, extending from the handle body on a side generally opposite the position on the handle body from which the loop extends, for supporting at least one other finger in order to facilitate manipulation of the stylet within the heart of a patient.

13. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 1, wherein the second support means extends outward from the handle body in the same general direction as the predetermined curve at the distal end of the stylet body.

7. A removable stylet for use in a retrograde cardioplegia catheter during insertion of the retrograde cardioplegia catheter into the coronary sinus of the heart, the stylet comprising:

(a) a stylet rod constructed of a substantially rigid material such that the stylet can impart the shape thereof upon a flexible cannula during insertion into the coronary sinus of a patient, the stylet rod having a predetermined curve at a distal end of the stylet body;

(b) a handle located at the proximal end of the stylet rod, the handle comprising;

(i) a handle body;

(ii) a rigid thumb rest located on a proximal end of the handle body for securely supporting the thumb of a user; and

(iii) a substantially rigid wire formed into a loop extending outwardly from a position on the handle body distal of the thumb rest means, for supporting at least one finger in order to allow manipulation of the stylet within the heart of a patient, the loop extending in a curve in the same general direction as the predetermined curve of the stylet rod; and

(c) blocking means for obstructing the flow of blood located on the distal end of the stylet rod, the blocking means having a sufficient diameter to impede the flow of blood through a tip of a cardioplegia catheter.

8. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 7, wherein the cardioplegia catheter with which the stylet is to be used includes an inflatable balloon, and wherein the blocking means for obstructing the flow of blood is positioned on the stylet rod at a location so as to impede the backflow of blood from the heart before the blood reaches the inflatable balloon on the cardioplegia catheter.

9. A method of placing a retrograde cardioplegia catheter incorporating a stylet with a handle into the coronary sinus of a patient comprising the steps:

(a) obtaining a removable stylet for use in a retrograde cardioplegia catheter during insertion of the catheter into the coronary sinus of the heart, the removable stylet comprising;

(1) a stylet rod constructed of a substantially rigid material such that the stylet can impart the shape thereof upon a flexible cannula during insertion into the coronary sinus of a patient, the stylet rod having a predetermined curve at a distal end of the stylet body;

(2) a handle located at the proximal end of the stylet rod, the handle comprising;

(i) a handle body;

(ii) thumb rest means, located at a proximal end of the handle body, for securely supporting the thumb of the user; and

(iii) finger placement means, extending outwardly from a position on the handle body distal of the thumb rest means, for supporting at least one finger in order to allow manipulation of the stylet with in the heart of a patient;

(b) pressing at least one finger of the user against the finger placement means of the handle of the stylet;

(c) pressing a thumb of the user against the thumb rest means on the stylet handle; and

(d) inserting the retrograde cardioplegia catheter within the coronary sinus of the patient through an incision permitting access to the coronary sinus with a slight movement of the at least one finger towards the user and keeping the thumb of the user relatively stationary.

10. A method of placing a retrograde cardioplegia catheter incorporating a stylet with a handle into the coronary sinus of a patient comprising the steps:

(a) obtaining a removable stylet for use in a retrograde cardioplegia catheter during insertion of the catheter into the coronary sinus of the heart, the removable stylet comprising;

(1) a stylet rod constructed of a substantially rigid material such that the stylet can impart the shape thereof upon a flexible cannula during insertion into the coronary sinus of a patient, the stylet rod having a predetermined curve at a distal end of the stylet body;

(2) a handle located at the proximal end of the stylet rod, the handle comprising;

(i) a handle body;

(ii) thumb rest means, located at a proximal end of the handle body, for securely supporting the thumb of the user; and

(iii) finger placement means, extending outwardly from a position on the handle body distal of the thumb rest means, for supporting at least one finger in order to allow manipulation of the stylet within the heart of a patient;

(b) pressing an index finger of the user against a side of the stylet handle;

(c) pressing a ring finger or the user against the finger placement means of the stylet handle;

(d) pressing a thumb of the user against a side of the stylet handle, while impressing the thumb rest of the stylet handle in the crotch formed between the index finger and the thumb; and

(e) inserting the retrograde cardioplegia catheter within the coronary sinus of the patient through an incision permitting access to the coronary sinus with a slight movement of the ring finger toward the user while keeping the thumb and index finger of the user relatively stationary.

11. A method of placing a retrograde cardioplegia catheter incorporating a stylet with a handle into the coronary sinus of a patient comprising the steps:

(a) obtaining a removable stylet for use in a retrograde cardioplegia catheter during insertion of the catheter into the coronary sinus of the heart, the removable stylet comprising;

(1) a stylet rod constructed of a substantially rigid material such that the stylet can impart the shape thereof upon a flexible cannula during insertion into the coronary sinus of a patient, the stylet rod having a predetermined curve at a distal end of the stylet body;

(2) a handle located at the proximal end of the stylet rod, the handle comprising;

(i) a handle body;

(ii) a thumb rest, located at a proximal end of the handle body, for supporting the thumb of the user;

(iii) a finger placement means, extending outwardly from a position on the handle body distal of the thumb, for supporting the ring finger in order to allow manipulation of the stylet within the heart of a patient;

(iii) a second finger placement means, extending outwardly from a position on the handle body distal of the thumb rest, for supporting the index finger in order to allow manipulation of the stylet within the heart of a patient; and

(b) pressing an index finger of the user against the second finger placement means of the stylet;

(c) pressing the ring finger of the user against the first finger placement means of the stylet handle;

(d) pressing a thumb of the user against the thumb rest on the stylet handle; and

(c) inserting the retrograde cardioplegia catheter within the coronary sinus of the patient through an incision permitting access to the coronary sinus with a slight movement of the ring finger toward the user and keeping the thumb and index finger of the user relatively stationary.

12. A removable stylet for use in a retrograde cardioplegia catheter during insertion of the retrograde cardioplegia catheter into the coronary sinus of the heart, the stylet comprising:

(a) a stylet rod constructed of a substantially rigid material such that the stylet can impart the shape thereof upon a flexible cannula during insertion into the coronary sinus of a patient, the stylet rod having a predetermined curve at a distal end of the stylet body;

(b) a handle located at the proximal end of the stylet rod, the handle having a surface area which allows tactile feedback and leverage during insertion of the catheter into the patient, the handle comprising;

(i) a handle body;

(ii) first support means, located at a proximal end of the handle body, for securely supporting a digit of a hand of a user so as to allow manipulation of the stylet within the heart of the patient, the first support means configured so as to securely support the digit in position; and

(iii) second support means, extending outwardly from a position on the handle body distal of the first support means, for supporting at least one other digit of a hand of the user on the handle of the stylet in order to allow manipulation of the stylet within the heart of a patient.

14. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 12, wherein the digit supported by the first support means is a thumb, and the at least one other digit supported by the second support means is a finger.

15. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 12, wherein the digit supported by the first support means is a finger, and the at least one other digit supported by the second support means is a thumb.

16. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 12, further comprising a third support means for supporting at least one other digit of the hand of a user.

17. A removable stylet for use in a retrograde cardioplegia catheter as defined in claim 12, wherein the stylet further comprises an obturator located on the distal end of the stylet rod of sufficient diameter to impede the flow of blood through a tip of the cardioplegia catheter.