Intracoronary exchange apparatus and method

• US 5,290,247 A
• Filed: 05/21/1991
• Issued: 03/01/1994
• Est. Priority Date: 05/21/1991
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Crittenden, James F.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Smith, Jeffrey A.
• Application Number:
  US07/703,603
• Time in Patent Office: 1,015 Days
• Field of Search: 604/171, 604/164, 604/170, 604/96, 604/264, 604/280, 604/158, 604/159, 604/102
• US Class Current: 604/171
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intracoronary sheath for use in catheter exchanges has an elongate tubular body with a proximally facing funnel at the proximal end of the sheath. A proximally extending wire for manipulating the sheath is attached to the proximal end of the sheath. The intracoronary sheath is advanced by manipulation of the wire over a first catheter positioned in a guide catheter and extends beyond the distal end of the guide catheter into the patient'"'"'s vascular system. After the first catheter is removed, a second catheter advanced through a guide catheter is guided by the funnel into the intracoronary sheath and through the vascular system to a desired position in the patient'"'"'s body. A second embodiment provides for the exchange of a second guidewire for a first guidewire. A first guidewire is positioned within a monorail-type catheter extending into the patient'"'"'s vascular system. The monorail type catheter is provided with a proximally facing funnel on a proximally facing opening leading into the lumen of the monorail catheter which receives the guidewire. After the first guidewire is removed, the second guidewire introduced. The funnel guides the guidewire into the proximally facing opening and then into the guidewire lumen of the monorail-type catheter.

Claims

1. An improved guidewire exchange apparatus for use in facilitating the substitution of a second guidewire for a first guidewire positioned within a monorail catheter, the monorail catheter having a guidewire lumen passage therethrough and a proximally-facing opening in the lumen passage adapted to receive a guidewire, the improvement comprising means associated with the proximally-facing opening for guiding the second guidewire into the lumen of the catheter while the proximally-facing opening is within a body lumen.

2. The invention of claim 1 wherein the means for guiding comprises a proximally facing funnel, the smaller opening of the funnel being attached to the proximally facing opening in the guidewire lumen, the larger opening being proximal of the smaller opening.

3. The invention of claim 2 wherein the monorail catheter is positioned in a guide catheter and wherein the diameter of the larger opening of the funnel approximates the diameter of the guide catheter.

4. A catheter exchange sheath for use in facilitating the substitution of a second catheter for a first catheter positioned within a guide catheter comprising:

an elongate sheath being of a length shorter than the guide catheter and having distal and proximal ends unattached to the guide catheter;

means associated with the proximal end of the sheath for guiding the second catheter into the elongate sheath;

means for controlling the axial position of the sheath while the second catheter is being substituted for the first catheter.

5. The invention of claim 4 wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximal end of the sheath, the larger opening being proximal of the smaller opening.

6. The invention of claim 4 wherein the means for advancing includes a wire attached to the sheath for moving the sheath through the body lumen a body lumen.

7. The invention of claim 4 wherein the sheath is on the order of 35 cm. in length.

8. The invention of claim 4 wherein the diameter of the sheath is less than the diameter of the guide catheter and the diameter of the larger opening of the funnel approximates the diameter of the guide catheter.

9. A catheter exchange sheath comprising:

a sheath adapted to be inserted into a guide catheter and having distal and proximal ends unattached to the guide catheter, the proximal end having a guide means attached thereto, the sheath further having a control means for controlling the axial position of the sheath within the guide catheter while the second catheter is being substituted for the first catheter, the distal end of the sheath when positioned extending out of the guide catheter with the proximal end of the sheath being in the vicinity of the distal end of the guide catheter.

10. The sheath of claim 9 where the guide means comprises a funnel whose larger opening faces proximally of the sheath and whose small opening is secured to the proximal end of the sheath.

11. The sheath of claim 9 where the control means is a wire attached near the proximal end of the sheath and extends proximally of the sheath.

12. A method for performing catheter exchange of a second catheter for a first catheter, the first catheter having a shaft with distal and proximal ends, the first catheter being positioned within a guide catheter, the distal end of the first catheter extending distally of the distal end of the guide catheter and being located in a desired location within a body lumen, the method comprising:

advancing a sheath having distal and proximal ends unattached to the guide catheter over the proximal end of the first catheter shaft through the guide catheter, the sheath having a means at the proximal end thereof for guiding the second catheter into the sheath;

positioning the sheath with its proximal end at a desired location within the guide catheter and distal end in the body lumen;

removing the first catheter shaft from the body lumen;

advancing a second catheter with distal and proximal ends through the guide catheter,

guiding the second catheter into the sheath via the guiding means; and

,

advancing the second catheter through the sheath and into the body lumen and locating the distal end of the catheter at the desired location within the body lumen.

13. The method of claim 12 wherein the guiding means comprises a proximally-facing funnel, the smaller opening of the funnel being secured to the proximal end of the sheath, the larger opening being proximal of the smaller opening.

14. The method of claim 12 wherein a wire attached to the sheath extends proximally of the sheath and extends through and beyond the guide catheter, and the steps of advancing and positioning the sheath comprise manipulation of the wire.

15. A method for performing the exchange of a second guidewire for a first guidewire, the first and second guidewires having distal and proximal ends, the first guidewire being contained in a monorail catheter, the first guidewire and monorail catheter being positioned within a guide catheter, the method comprising:

removing the first guidewire shaft from the monorail catheter by pulling on its proximal end;

advancing the distal end of the second guidewire through the guide catheter by manipulating its proximal end;

guiding the second guidewire into the monorail catheter via a guiding means; and

,

advancing the second guidewire through the monorail catheter and locating the distal end of the guidewire at the desired location with respect to the monorail catheter.

16. The method of claim 15 wherein the guiding means comprises a proximally facing funnel, the monorail catheter having a guidewire lumen and a proximally facing opening into the guidewire lumen, the smaller opening of the funnel being secured to the proximally facing opening, the larger opening being proximal of the smaller opening.

17. A method for performing catheter exchange of a second catheter for a first catheter, the first catheter having a shaft with distal and proximal ends, the first catheter being positioned within a guide catheter, the distal end of the first catheter extending distally of the distal end of the guide catheter and being located in a desired location within a body lumen, the method comprising:

advancing a sheath having distal and proximal ends unattached to the guide catheter over the proximal end of the first catheter shaft through the guide catheter, the sheath having a means at the proximal end thereof for guiding the second catheter into the sheath;

positioning the sheath with its proximal end at a desired location within the guide catheter and distal end in the body lumen;

removing the first catheter shaft from the body lumen;

advancing a second catheter with distal and proximal ends through the guide catheter,

guiding the second catheter into the sheath via the guiding means; and

,

advancing the second catheter through the sheath and into the body lumen and locating the distal end of the catheter at the desired location within the body lumen; and

further comprising a proximal fitting at the proximal end of the first catheter, and including the step of removing the proximal fitting from the first catheter prior to the step of advancing the sheath.

18. A catheter exchange sheath for use in facilitating the substitution of a second catheter for a first catheter positioned within a guide catheter comprising:

an elongate sheath being of a length shorter than the guide catheter and having distal and proximal ends unattached to the guide catheter;

means associated with the proximal end of the sheath for guiding the second catheter into the elongate sheath;

means for advancing the sheath through a guide catheter;

wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximal end of the sheath, the larger opening being proximal of the smaller opening; and

wherein the funnel further comprises at least one perforation.

19. A catheter exchange sheath for use in a facilitating the substitution of a second catheter for a first catheter positioned within a guide catheter comprising:

an elongate sheath being of a length shorter than the guide catheter and having distal and proximal ends unattached to the guide catheter;

means associated with the proximal end of the sheath for guiding the second catheter into the elongate sheath;

means for advancing the sheath through a guide catheter;

wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximal end of the sheath, the larger opening being proximal of the smaller opening; and

wherein the funnel further comprises at least one slit, extending from the larger opening of the funnel to the smaller opening of the funnel.

20. Apparatus for exchanging a second catheter for a first catheter, the first catheter having a shaft with distal and proximal ends, the first catheter being positioned within a guide catheter, the distal end of the first catheter extending distally of the distal end of the guide catheter and being located in a desired location within a body lumen, comprising:

a sheath adapted to be inserted into the guide catheter over the first catheter and having distal and proximal ends unattached to the guide catheter, the proximal end having attached thereto a means for guiding the second catheter, the sheath further having a control means for advancing the sheath through the positioning the sheath within the guide catheter, the distal end of the sheath when positioned being in the vicinity of the distal end of the first catheter with the proximal end of the sheath being in the vicinity of the distal end of the guide catheter;

means for removing the first catheter shaft by its proximal and from the body lumen;

means for advancing a second catheter with distal end proximal ends through the guide catheter, the guide means guiding the catheter into the sheath; and

means for advancing the second catheter through the sheath and into the body lumen and for locating the distal end of the second catheter at the desired location within the body lumen.

21. A method for performing catheter exchange of a second catheter for a first catheter, the first catheter having a shaft with distal and proximal ends, the first catheter being positioned within a guide catheter, the distal end of the first catheter extending distally of the distal end of the guide catheter and being located in a desired location within a body lumen, the method comprising:

advancing a sheath having distal and proximal lends unattached to the guide catheter over the proximal end of the first catheter shaft through the guide catheter, the sheath having a means at the proximal end thereof for guiding the second catheter into the sheath;

positioning the sheath with its proximal end at a desired location within the guide catheter and distal end in the body lumen;

removing the first catheter shaft from the body lumen;

advancing a second catheter with distal and proximal ends through the guide catheter,

guiding the second catheter into the sheath via the guiding means; and

,

advancing the second catheter through the sheath and into the body lumen and locating the distal end of the catheter at the desired location within the body lumen;

wherein the guiding means comprises a proximally-facing funnel, the smaller opening of the funnel being secured to the proximal end of the sheath, the larger opening being proximal of the smaller opening; and

further comprising at least one slit extending from the larger opening of the funnel at least partially to the small opening of the funnel.

22. A method for performing catheter exchanger of a second catheter for a first catheter, the first catheter having a shaft with distal and proximal ends, the first catheter being positioned within a guide catheter, the distal end of the first catheter extending distally of the distal end of the guide catheter and being located in a desired location within a body lumen, the method comprising;

advancing a sheath having distal and proximal ends unattached to the guide catheter over the proximal end of the first catheter shaft through the guide catheter, the sheath having a means at the proximal end thereof for guiding the second catheter into the sheath;

positioning the sheath with its proximal end at a desired location within the guide catheter and distal end in the body lumen;

removing the first catheter shaft from the body lumen;

advancing a second catheter with distal and proximal ends through the guide catheter,

guiding the second catheter into the sheath via the guiding means;

advancing the second catheter through the sheath and into the body lumen and locating the distal end of the catheter at the desired location within the body lumen;

wherein the guiding means comprises a proximally-facing funnel, the smaller opening of the funnel being secured to the proximal end of the sheath, the larger opening being proximal of the smaller opening; and

wherein the funnel further comprises at least one perforation.

23. An improved guidewire exchange apparatus for use in facilitating the substitution of a second guidewire for a first guidewire positioned within a monorail catheter, the monorail catheter having a guidewire lumen passage therethrough and a proximally-facing opening in the lumen passage adapted to receive a guidewire, the improvement comprising means associated with the proximally-facing opening for guiding the second guidewire into the lumen of the catheter;

wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximally-facing opening in the guidewire lumen, the larger opening being proximal of the smaller opening; and

wherein the funnel further comprises at least one perforation.

24. An improved guidewire exchange apparatus for use in facilitating the substitution of a second guidewire for a first guidewire positioned within a monorail catheter, the monorial catheter having a guidewire lumen passage therethrough and a proximally-facing opening in the lumen passages adapted to receive a guidewire, the improvement comprising means associated with the proximally-facing opening for guiding the second guidewire into the lumen of the catheter;

wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximally-facing opening in the guidewire lumen, the larger opening being proximal of the smaller opening;

wherein the funnel further comprises at least one perforation; and

further comprising at least one slit extending from the large opening of the funnel at least partially to the smaller opening of the funnel.

25. A catheter exchange sheath for use in facilitating the substitution of a second catheter for a first catheter positioned within a guide catheter comprising:

an elongate sheath being of a length shorter than the guide catheter and having distal and proximal ends unattached to the guide catheter;

means associated with the proximal end of the sheath for guiding the second catheter into the elongate sheath;

means for advancing the sheath through a guide catheter;

wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximal end of the sheath, the larger opening being proximal of the smaller opening; and

further comprising at least one slit extending from the larger opening of the funnel at least partially to the small opening of the funnel.

26. A catheter exchange sheath comprising;

a sheath adapted to be inserted into a guide catheter and having distal and proximal ends unattached to the guide catheter, the proximal end having a guide means attached thereto, the sheath further having a control means for advancing the sheath through and positioning the sheath within the guide catheter, the distal end of the sheath when positioned extending out of the guide catheter with the proximal end of the sheath being in the vicinity of the distal end of the guide catheter;

where the guide means comprises a funnel whose larger opening faces proximally of the sheath and whose small opening is secured to the proximal end of the sheath; and

further comprising at least one slit extending from the larger opening of the funnel at least partially to the small opening of the funnel.

27. A catheter exchange sheath comprising:

a sheath adapted to be inserted into a guide catheter and having distal and proximal ends unattached to the guide catheter, the proximal end having a guide means attached thereto, the sheath further having a control means for advancing the sheath through and positioning the sheath within the guide catheter, the distal end of the sheath when positioned extending out of the guide catheter with the proximal end of the sheath being in the vicinity of the distal end of the guide catheter;

where the guide means comprises a funnel whose larger opening faces proximally of the sheath and whose small opening is secured to the proximal end of the sheath; and

wherein the funnel further comprises at least one perforation.

28. An improved guidewire exchange apparatus for use in a facilitating the substitution of a second guidewire for a first guidewire positioned within a monorail catheter, the monorail catheter having a guide wire lumen passage therethrough and a proximally-facing opening in the lumen passage adapted to receive a guidewire, the improvement comprising means associated with the proximally-facing opening for guiding the second guidewire into the lumen of the catheter;

wherein the means for guiding comprises a proximally-facing funnel, the smaller opening of the funnel being attached to the proximally-facing opening the guidewire lumen, the larger opening being proximal of the smaller opening;

wherein the funnel further comprises at least one perforation;

wherein the monorail catheter is positioned in a guide catheter and wherein the diameter of the larger opening of the funnel approximates the diameter of the guide catheter; and

further comprising at least one slit extending from the larger opening of the funnel at least partially to the smaller opening of the funnel.