Catheter for balloon angioplasty

• US 4,927,413 A
• Filed: 11/21/1988
• Issued: 05/22/1990
• Est. Priority Date: 08/24/1987
• Status: Expired due to Term

• Current Assignee: Calmedica LLC
• Original Assignee: Progressive Angioplasty Systems, Inc. (Medtronic Plc)
• Inventors: Hess, Robert
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US07/299,149
• Time in Patent Office: 547 Days
• Field of Search: 128/344, 128/348.1, 128/656-658, 128/772, 604/95, 604/96, 604/170, 604/194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other
• CPC Class Codes: A61M 2025/09066 having a coil without a core possibly combined with a sheath
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter for balloon angioplasty includes a flexible shaft (12) defining a hollow passage (18), the shaft having first (14) and second (16) ends. A core means (20) is movably and removably mounted within the hollow passage, the core means having first and second ends adjacent the first and second ends of the shaft. The core means has a first flexible portion (26) adjacent the first end and a second flexible portion (28) of greater flexibility adjacent the second end. The core means may also have an enlarged terminal knob (30) at the second end. A flexible guide wire (32) may be fixed to the second end of either the shaft or the core means. The catheter may be inserted into a vascular tree. After removal of the core means, the core means may be replaced by an exchange wire, an angioscope, a laser fiber, or a rotatable wire. Also, when the core means is replaced by an exchange wire, the shaft may then be removed and replaced by either a different balloon angioplasty catheter or a perfusion catheter.

Claims

1. A catheter for balloon angioplasty comprising:

a flexible shaft having a sealed hollow passage defined therein and having a first proximal end and a second distal end, both said ends being open, said flexible shaft being a coated wire wound member, said coating being fluid impervious and extending along substantially the entire length of the wire wound member, the wire wound member being substantially round in cross-section and resistant to flattening in cross-section when said flexible shaft is bent along the length thereof in the tortuous path of a coronary artery, allowing close tolerances for a member that may be inserted therein, the coated wire wound member inherently having high column strength providing pushability while maintaining a high degree of flexibility and being resistant to a preset in overall shape when the catheter is coiled for storage;

a core means movably, removably and substantially contained within said flexible shaft, said core means having a first proximate end and a second distal end and having a first flexible portion extending from said first proximate end and a second flexible portion terminating in said second distal end of said core means, said second flexible portion being of greater flexibility than said first flexible portion, said second flexible portion having a variable core strength along the length thereof from greater to lesser strength extending toward the second distal end of said core means, said second flexible portion being tapered along the length thereof such that essentially all of said second flexible portion can generally be extended within a coronary artery to maximize the variable stiffness of said catheter, the combination of the core means and the coated wire wound member providing variable trackability, pushability and flexibility of said catheter;

a flexible guide wire fixed to and further axially extending from the second distal end of said core means; and

an inflatable member having a non-inflatable sheath covering an external surface of said flexible shaft near the second distal end of said flexible shaft and further including means for inflating said inflatable member.

2. A catheter as in claim 1 wherein said second flexible portion of said core means comprises a series of tapered sections.

3. A kit comprising:

a catheter having a flexible shaft having a sealed hollow passage defined therein and having a first proximal end and a second distal end, both said ends being open, said flexible shaft being a coated wire wound member, said coating being fluid impervious and extending along substantially the entire length of the wire wound member, the wire wound member being substantially round in cross-section and resistant to flattening in cross-section when said flexible shaft is bent along the length thereof in the tortuous path of a coronary artery, allowing close tolerances for a member that may be inserted therein, the coated wire wound member inherently having high column strength providing pushability while maintaining a high degree of flexibility and being resistant to a preset in overall shape when the catheter is coiled for storage, said catheter including a core means movably, removably and substantially contained within said flexible shaft, said core means having a first proximate end and a second distal end and having a first flexible portion extending from said first proximate end and a second flexible portion terminating in said second distal end of said core means, said second flexible portion being of greater flexibility than said first flexible portion, said second flexible portion having a variable core strength along the length thereof from greater to lesser strength extending toward the second distal end of said core means, said second flexible portion being tapered along the length thereof such that essentially all of said second flexible portion can generally be extended within a coronary artery to maximize the variable stiffness of said catheter, the combination of the core means and the coated wire wound member providing variable trackability, pushability and flexibility of said catheter, said catheter including a flexible guide wire fixed and further axially extending from the second distal end of said core means, said catheter including an inflatable member having a non-inflatable sheath covering an external surface of said flexible shaft near the second distal end of said flexible shaft and further including means for inflating said inflatable member;

components in the form of an exchange wire, an angioscope, a laser fiber, a rotatable wire, and a thermal angioplasty means for thermal oblation and remodeling of tissue, all of said components sized to be insertable within said flexible shaft upon removal of said core means; and

a different balloon angioplasty catheter and a perfusion catheter, said balloon angioplasty catheter and said perfusion catheter sized to be inserted over said exchange wire.

4. A method of performing a combined fixed wire and movable wire angioplasty including the steps of:

(a) inserting a catheter in a vascular tree, said catheter including a flexible shaft having a sealed hollow passage defined therein and having a first proximal end and a second distal end, both said ends being open, said flexible shaft being a coated wire wound member, said coating being fluid impervious and extending along substantially the entire length of the wire wound member, the wire wound member being substantially round in cross-section and resistant to flattening in cross-section when said flexible shaft is bent along the length thereof in the tortuous path of a coronary artery, allowing close tolerances for a member that may be inserted therein, the coated wire wound member inherently having high column strength providing pushability while maintaining a high degree of flexibility and being resistant to a preset in overall shape when the catheter is coiled for storage, said catheter including a core means movably, removably and substantially contained within said flexible shaft, said core means having a first proximate end and a second distal end and having a first flexible portion extending from said first proximate end and a second flexible portion terminating in said second distal end of said core means, said second flexible portion being of greater flexibility than said first flexible portion, said second flexible portion having a variable core strength along the length thereof from greater to lesser strength extending toward the second distal end of said core means, said second flexible portion being tapered along the length thereof such that essentially all of said second flexible portion can generally be extended within a coronary artery to maximize the variable stiffness of said catheter, the combination of the core means and the coated wire wound member providing variable trackability, pushability and flexibility of said catheter, said catheter including a flexible guide wire fixed to and further axially extending from the second distal end of said core means, said catheter including an inflatable member having an integral non-inflatable sheath covering an external surface of said flexible shaft near the second distal end of said flexible shaft and further including means for inflating said inflatable member; and

(b) moving said second flexible portion of said core means axially relative to said second distal end of said flexible shaft, extension of the second flexible portion relative to the second distal end of said flexible shaft increasing pushability of the catheter and decreasing flexibility and trackability, retraction of said second flexible portion from such extended position increasing flexibility and trackability of the catheter with an accompanying decrease in pushability.

5. A method according to claim 4 further including the steps of:

(c) removing said core means through said first proximal end of said flexible shaft;

(d) inserting an exchange wire within said flexible shaft;

(e) removing said flexible shaft; and

(f) inserting a different balloon angioplasty catheter over said exchange wire.

6. A method according to claim 4 further including the steps of:

(c) removing said core means through said first proximal end of said flexible shaft;

(d) inserting an exchange wire within said flexible shaft;

(e) removing said flexible shaft; and

(f) inserting a perfusion catheter over said exchange wire.

7. A method according to claim 4 further including the steps of:

(c) removing said core means through said first proximal end of said flexible shaft; and

(d) inserting an angioscope within said flexible shaft.

8. A method according to claim 4 further including the steps of:

(c) removing said core means through said first proximal end of said flexible shaft; and

(d) inserting a laser fiber within said flexible shaft.

9. A method according to claim 4 further including the steps of:

(c) removing said core means through said first proximal end of said flexible shaft; and

(d) inserting a rotatable wire within said flexible shaft.

10. A method according to claim 4 further including the steps of:

(c) removing said core means through said first proximal end of said flexible shaft; and

(d) inserting within said flexible shaft a thermal angioplasty means for thermal oblation and remodeling of tissue.