Controllable flexibility catheter with eccentric stiffener

• US 4,909,787 A
• Filed: 08/11/1988
• Issued: 03/20/1990
• Est. Priority Date: 08/14/1986
• Status: Expired due to Fees

• Current Assignee: Danforth Biomedical Incorporated
• Original Assignee: John W. Danforth
• Inventors: Danforth, John W.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/231,625
• Time in Patent Office: 586 Days
• Field of Search: 128/344, 128/348.1, 604/95-103, 604/280-282
• US Class Current: 604/95.03
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A guiding catheter 20 of variable, operator-controlled flexibility to be used in the performance of a percutaneous translumenal coronary angioplasty procedure is described which includes an elongate housing 42 suitable for insertion into an artery, as well as an operator-controlled variable stiffener coupled to the distal aspect of the catheter to permit the operator performing the angioplasty procedure to increase the rigidity of the catheter. In a preferred embodiment the stiffening apparatus consists of a fluid-filled chamber eccentrically displaced along the longitudinal axis of the catheter housing nearly encompassing the housing that contains a segment capable of asymmetric elongation when subjected to hydrostatic pressure resulting in the development of torque and increased rigidity of the distal end as desired by the operator. Increasing the rigidity of the guiding catheter, once installed within the coronary ostium, precludes disengagement of the guiding catheter, thus expediting the performance and enhancing the safety of the procedure.

Claims

1. A catheter comprising:

an elongate housing having an opening extending from a proximal end to a distal end of its length; and

controllable stiffening means coupled to a substantially stiffenable portion of the length of the elongate housing to provide at least a first higher flexibility of said substantially stiffenable portion of the elongate housing and a second lower flexibility of said substantially stiffenable portion of the elongate housing as selected by a user of the catheter, the controllable stiffening means comprising a primary chamber having at least a first wall portion and a second wall portion and adapted to be filled with a fluid, which chamber is eccentrically disposed around the elongate housing along said substantially stiffenable portion of the length, said first wall portion being formed by a portion of said elongate housing, wherein when said chamber is filled with a fluid, said second wall portion is elongate with respect to said first wall portion.

2. A catheter as in claim 1 further comprising a channel extending from the primary chamber to the proximal end to permit pressurization of the primary chamber.

3. A catheter as in claim 2 wherein the primary chamber comprises a cylindrical member disposed around the elongate housing and affixed thereto along a portion of the length of the primary chamber.

4. A catheter as in claim 2 wherein an outer surface of the primary chamber is capable of asymmetric elongation when subjected to hydrostatic pressure, resulting in the development of torque.

5. A catheter as in claim 1 wherein the first higher flexibility causes the catheter to assume a bent configuration.

6. A catheter as in claim 11 wherein the bent configuration is a configuration adapted for manipulating the catheter in a position suitable for the performance of percutaneous coronary angioplasty.

7. A catheter as in claim 1 wherein the said substantially stiffenable portion of the length comprises a region in closer proximity to the distal end than to the proximal end.

8. A catheter as in claim 1 wherein the primary chamber includes at least one kerf therein to allow a sharper radius of curvature at that location.

9. A catheter as in claim 1 wherein the primary chamber includes a region of elastic material to allow a sharper radius of curvature at that location.

10. A catheter as claimed in claim 1, wherein the primary chamber includes:

at least two elastic segments; and

at least one inelastic segment interposed between said two elastic segments.

11. A catheter, as claimed in claim 1, wherein:

said second wall portion comprises a sufficient amount of substantially inelastic material to permit said elongation with respect to said first wall portion.

12. A catheter, as claimed in claim 1, wherein:

said second wall portion includes at least one wedge-shaped portion of elastic material.

13. A catheter, as claimed in claim 2, further comprising:

means or venting air from said catheter when fluid is infused in said channel.

14. A catheter, as claimed in claim 2, further comprising:

a longitudinally extending port configured for venting air when fluid is infused in said channel.

15. A catheter, as claimed in claim 14, further comprising:

valve means for controlling flow through said port.

16. A catheter, as claimed in claim 14, further comprising:

means for venting air from said catheter when fluid is infused in said secondary channel.

17. A catheter, as claimed in claim 13, wherein said secondary chamber is disposed at a predetermined angle with respect to said primary chamber to permit deflecting the distal portion of said catheter.

18. A method, as claimed in claim 17, further comprising:

venting air from said catheter.

19. A catheter comprising:

an elongate housing an opening extending from a proximal end to a distal end of its length;

controllable stiffening means coupled to a portion of the length of the elongate housing to provide at least a first higher flexibility of that portion of the elongate housing and a second lower flexibility of that portion of the elongate housing as selected by a user of the catheter, the controllable stiffening means comprising a primary chamber adapted to be filled with a fluid, which chamber is eccentrically disposed around the elongate housing along the portion of the length;

a channel extending from the primary chamber to the proximal end to permit pressurization of the primary chamber; and

a secondary chamber disposed along the elongate housing more proximal to the distal end than the primary chamber.

20. A catheter as in claim 19 further comprising a secondary channel extending adjacent the opening of the elongate housing from the proximal end and coupled to the secondary chamber to permit pressurization thereof.

21. A catheter as in claim 20 wherein the secondary chamber is positioned axially offset from the primary chamber.

22. A catheter as in claim 21 wherein an outer surface of the secondary fluid-filled chamber is capable of asymmetric elongation when subjected to hydrostatic pressure resulting in deflection of the tip of the catheter.

23. A catheter comprising:

an elongate housing having an opening extending from a proximal end to a distal end of its length;

controllable stiffening means coupled to a portion of the length of the elongate housing to provide at least a first higher flexibility of that portion of the elongate housing as second lower flexibility of that portion of the elongate housing and a selected by a user of the catheter, the controllable stiffening means comprising a primary chamber adapted to be filled with a fluid, which chamber is eccentrically disposed around the elongate housing along the portion of the length; and

an angioplasty dilation catheter disposed within the opening.

24. A method for performing an angioplasty procedure using a guiding catheter having controllable stiffening means comprising a primary chamber adapted to be filled with a fluid which chamber is eccentrically disposed around the guiding catheter and affixed to a portion of the guiding catheter in proximity to the distal end comprising:

introducing the guiding catheter to a desired position within a patient;

employing the controllable stiffening means to increase the rigidity of the portion of the catheter to which the controllable stiffening means is affixed;

performing the angioplasty procedure;

employing the controllable stiffening means to reduce the rigidity of the portion of the catheter; and

removing the catheter.