Method of, and stylet apparatus for, installing a retrograde coronary cannula

• US 5,401,244 A
• Filed: 04/28/1994
• Issued: 03/28/1995
• Est. Priority Date: 11/19/1992
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Minnesota Mining and Manufacturing Co (3M Company)
• Inventors: Boykin, Christopher M., Vaalburg, Thomas T.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/238,416
• Time in Patent Office: 334 Days
• Field of Search: 604/95, 604/170, 604/180, 604/280, 604/282, 604/264, 604/164-166, 604/49-53, 128/657, 128/772
• US Class Current: 604/510
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation

Abstract

A coronary cannula and installation stylet set, the stylet having a shaft extending through the cannula of the coronary cannula to facilitate the installation of the cannula. The shaft has a stiff but resilient proximal portion and a deformable distal portion, shorter than the proximal portion, which can be deformed to hold the distal tip of the coronary cannula in a desired configuration to facilitate the insertion of the cannula into the coronary sinus. According to the method of this invention, the coronary cannula and installation stylet are provided, the distal tip of the coronary cannula is shaped by deforming the deformable distal portion of the stylet therein to facilitate its insertion into the coronary sinus. The tip of the coronary cannula is manipulated into the coronary sinus, and the stylet is removed from the coronary cannula once the coronary canula is in place in the coronary sinus.

Claims

1. A stylet adapted to fit inside a retrograde coronary cannula to facilitate the installation of the cannula into the coronary sinus, the stylet comprising:

a handle;

a shaft extending from the handle and adapted to fit inside the coronary cannula, the shaft comprising;

a generally elongate proximal portion means for providing stiffness to a proximal portion of the cannula in which the stylet is received; and

a generally elongate, deformable distal portion means, shorter than the proximal portion means and extending distally from the proximal portion means, for providing stiffness to a distal portion of the cannula in which the stylet is received, the deformable distal portion means including deformable means, readily deformable in comparison with the proximal portion means, for holding the distal tip of the coronary cannula in a desired configuration in which the distal portion means has been deformed to facilitate the insertion of the cannula into the coronary sinus;

the proximal portion means being relatively stiff in comparison with the deformable distal portion means.

2. The stylet according to claim 1 wherein the shaft comprises a malleable wire forming the deformable means of the distal portion means.

3. The stylet according to claim 2 wherein the wire is an annealed stainless steel.

4. The stylet according to claim 2 wherein the wire has a Tenius-Olsen stiffness of between about 0.005 in/in and about 0.025 in/in.

5. The stylet according to claim 2 wherein the malleable wire includes a distal portion forming the distal portion means and a proximal portion extending proximally of the distal portion;

the proximal portion means comprising the proximal portion of the wire, and a sleeve surrounding the proximal portion of the wire, stiffening the proximal portion means of the shaft, the sleeve being relatively rigid in comparison with the malleable wire, thereby making the proximal portion means less readily deformable than the distal portion means.

6. The stylet according to claim 1 wherein the deformable distal portion means has a length of between about 1.5 and about 6 inches, and the proximal portion means has a length of between about 9 and about 10 inches.

7. A coronary cannula and installation stylet set comprising:

a retrograde coronary sinus cannula having a lumen and defining proximal and distal directions; and

an installation stylet comprising;

a handle defining a proximal end of the stylet; and

a shaft extending distally from the handle and extending through the lumen of the coronary cannula, the shaft comprising;

a generally elongate proximal portion means for providing stiffness to a proximal portion of the cannula in which the stylet is received; and

a generally elongate, deformable distal portion means, shorter than the proximal portion means and extending distally from the proximal portion means, for providing stiffness to a distal portion of the cannula in which the stylet is received, the deformable distal portion means including deformable means, readily deformable in comparison with the proximal portion means, for holding the distal tip of the coronary cannula in a desired configuration in which the distal portion means has been deformed to facilitate the insertion of the cannula into the coronary sinus

the proximal portion means being relatively stiff in comparison with the distal portion means.

8. The coronary cannula and stylet set according to claim 7 wherein the shaft comprises a malleable wire forming the deformable means of the distal portion means.

9. The coronary cannula and stylet set according to claim 8 wherein the wire is an annealed stainless steel.

10. The coronary cannula and stylet set according to claim 8 wherein the wire has a Tenius-Olsen stiffness of between about 0.005 in/in and about 0.025 in/in.

11. The coronary cannula and stylet set according to claim 8 wherein the malleable wire includes a distal portion forming the distal portion means and a proximal portion extending proximally of the distal portion;

the proximal portion means comprising a sleeve surrounding the proximal portion of the wire, stiffening the proximal portion means of the shaft, the sleeve being relatively rigid in comparison with the malleable wire, thereby making the proximal portion means less readily deformable than the distal portion means.

12. The coronary cannula and stylet set according to claim 8 wherein the deformable distal portion means has a length of between about 1.5 and about 6 inches, and the proximal portion means has a length of between about 9 and about 10 inches.

13. A method of installing a retrograde coronary cannula in the coronary sinus, the method comprising the steps of:

providing a coronary cannula having a lumen and defining proximal and distal ends and a tip portion adjacent the distal end, and a stylet having a shaft extending through the lumen of the cannula, the shaft having a proximal portion, and a deformable distal portion shorter and more readily deformable than the proximal portion, the shaft being sufficiently long that the deformable distal portion extends within the lumen of the cannula generally to the tip of the coronary cannula, with the proximal portion of the shaft received within the lumen of the cannula;

inserting the stylet into the lumen of the cannula such that the distal and proximal portions of the shaft of the stylet are received in the lumen of the cannula;

either before or after the step of inserting the stylet into the lumen of the cannula, deforming the deformable distal portion of the stylet in order to shape the tip of the cannula into which the stylet shaft is inserted either before or after this step, thereby to facilitate insertion of the cannula into the coronary sinus;

manipulating the tip portion of the coronary cannula into the coronary sinus; and

removing the stylet from the coronary cannula when the coronary cannula is in place in the coronary sinus.

14. The method of installing a retrograde coronary cannula according to claim 13 wherein the deformable distal portion of the stylet shaft comprises a malleable wire between about 1.5 and about 6 inches long, the step of deforming the distal portion of the stylet shaft further comprising deforming the malleable wire.

15. The method of installing a retrograde coronary cannula according to claim 13 wherein the deformable distal portion of the stylet shaft comprises a malleable wire having a Tenius-Olsen stiffness of between about 0.005 in/in and about 0.025 in/in;

the step of deforming the distal portion of the stylet shaft further comprising deforming the malleable wire.

16. A method of installing a retrograde coronary cannula in the coronary sinus, the method comprising the steps of:

providing a coronary cannula with the shaft of a stylet extending through the lumen of the cannula, the shaft comprising a deformable wire and a tube extending over the proximal portion of the wire to make the proximal portion of the shaft stiff but flexible, with the wire protruding from the tube and forming a deformable distal portion comprising less than half the length of the shaft, the shaft being sufficiently long that the deformable distal portion extends generally to the tip of the coronary cannula;

shaping the tip of the coronary cannula by deforming the deformable distal portion of the stylet therein to facilitate its insertion into the coronary sinus;

manipulating the tip of the coronary cannula into the coronary sinus; and

removing the stylet from the coronary cannula when the coronary cannula is in place in the coronary sinus.

17. The method of installing a coronary cannula according to claim 16 wherein the deformable distal portion of the stylet is between about 1.5 and about 6 inches long.

18. The method of installing a retrograde coronary cannula according to claim 16 wherein the deformable distal portion of the stylet shaft has a Tenius-Olsen stiffness of between about 0.005 in/in and about 0.025 in/in.

19. A coronary cannula and installation stylet set comprising:

a retrograde coronary sinus cannula having a lumen and defining proximal and distal ends and a tip portion generally adjacent the distal end; and

an installation stylet comprising;

a handle defining a proximal end of the stylet; and

a generally elongate shaft extending distally from the handle and extending substantially through the lumen of the coronary cannula, the shaft comprising;

a generally elongate malleable wire having proximal and distal portions; and

a generally elongate sleeve surrounding the proximal portion of the malleable wire, the sleeve having a length longer than the length of the distal portion of the malleable wire and being relatively stiff in comparison with the malleable wire to provide stiffness to a proximal portion of the cannula;

the distal portion of the malleable wire extending distally from the sleeve, the distal portion of the malleable wire being readily deformable in comparison with the sleeve, thereby facilitating deforming the malleable wire to hold the distal tip of the coronary cannula in a desired configuration to facilitate the insertion of the cannula into the coronary sinus.

20. The coronary cannula and stylet set according to claim 19 wherein the malleable wire is an annealed stainless steel, the malleable wire having a Tenius-Olsen stiffness of between about 0.005 in/in and about 0.025 in/in.

21. The coronary cannula and stylet set according to claim 19 wherein the deformable distal portion of the malleable wire has a length of between about 1.5 and about 6 inches, and the sleeve has a length of between about 9 and about 10 inches.