Drug delivery catheters that attach to tissue and methods for their use

• US 20020082584A1
• Filed: 12/22/2000
• Published: 06/27/2002
• Est. Priority Date: 12/22/2000
• Status: Active Grant

• Current Assignee: Biocardia Deviceco, Inc.
• Original Assignee: Biocardia Deviceco, Inc.
• Inventors: Altman, Peter A., Rosenman, Daniel C., McEtchin, Douglas, Maston, Robert E., Kayser, Daniel J., Hakim, Brian K.
• Granted Patent: US 6,511,471 B2
• Time in Patent Office: Days
• US Class Current: 604/523
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A system and method for delivering a drug to a target site within a patient'"'"'s body. The system and method include a steerable guide catheter and a drug delivery catheter. The steerable guide catheter has a first extension tube and a second extension tube that are joined together and form a shoulder. The delivery catheter has a distal docking segment and a proximal docking segment. The guide catheter is inserted into the patient'"'"'s body, then the delivery catheter is inserted into the guide catheter. The distal docking segment engages the first extension tube, the proximal docking segment engages the second extension tube, and the shoulder limits the distance the delivery catheter can be inserted into the guide catheter. Also, once the delivery catheter is inserted it can be rotated to attach the helical tip to the target site. The guide catheter also includes a steering mechanism as well as a friction mechanism which controls the tension on the steering mechanism. The delivery catheter also includes two luer fittings, each having its own lumen.

Claims

1. A system for delivering a drug to a target site within a patient'"'"'s body comprising a drug delivery catheter that docks onto a steerable guide catheter, wherein:

the steerable guide catheter comprises;

a housing composed of a top half and a bottom half, the housing having a longitudinal axis, a distal end, and a width;

a guide tube protruding out of the distal end of the housing along the longitudinal axis of the housing;

a first extension tube located within the housing and substantially aligned with the longitudinal axis of the housing, the first extension tube is connected to the guide tube, the first extension having a diameter;

a second extension tube located within the housing and substantially aligned with the longitudinal axis of the housing, the second extension tube is connected to the first extension tube, the second tube having a diameter greater than the diameter of the first extension tube;

a shoulder created by the joining of the first extension tube with the second extension tube; and

a steering knob, located outside the top half of the housing, for steering the guide tube;

the delivery catheter comprises;

a handle having a longitudinal axis, a distal end, and a proximal end;

a delivery tube protruding out of the distal end of the handle and aligned substantially along the longitudinal axis of the handle;

a luer fitting attached to the proximal end of the handle;

a proximal docking segment protruding out of the distal end of the handle and encompassing the delivery tube;

a distal docking segment protruding out of the distal end of the handle and encompassing the delivery tube and the proximal docking segment;

a lumen operatively connected to the luer fitting, the lumen runs along the longitudinal axis of the handle up through the delivery tube;

a helical tip, attached to the delivery tube, for injecting a drug into the target site;

wherein when the delivery catheter is inserted into the guide catheter the delivery tube is inserted within the guide tube, the distal docking segment is inserted into the first extension tube, the proximal docking segment is inserted into the second extension tube, and the shoulder limits the distance the delivery catheter inserts into the guide catheter.

2. The system of claim 1 wherein the steerable guide catheter further comprises:

a crank located within the housing, the crank being operatively connected to the steering knob such that rotation of the steering knob causes rotation of the crank;

a pullwire operatively connected to the crank such that rotation of the crank affects the tension on the pullwire; and

a pin operatively connected to the housing and the crank.

3. A system for delivering a drug to a target site comprising a drug delivery catheter that docks onto a steerable guide catheter, wherein:

the steerable guide catheter comprises;

a housing composed of a top half and a bottom half, the housing having a longitudinal axis, a distal end, and a width;

a guide tube protruding out the distal end of the housing along the longitudinal axis of the housing;

a first extension tube located within the housing and substantially aligned with the longitudinal axis of the housing, the first extension tube is connected to the guide tube, the first extension having a diameter;

a second extension tube located within the housing and substantially aligned with the longitudinal axis of the housing, the second extension tube is connected to the first extension tube, the second tube having a diameter greater than the diameter of the first extension tube;

a shoulder created by the joining of the first extension tube with the second extension tube;

a steering knob, located outside the top half of the housing, for steering the guide tube;

a crank located within the housing, the crank is operatively connected to the steering knob such that rotation of the steering knob causes rotation of the crank;

a pullwire operatively connected to the crank such that rotation of the crank affects the tension on the pullwire;

a friction knob, located outside the bottom half of the housing, for increasing or decreasing the friction on the steering knob;

a pin operatively connected to the bottom half of the housing, the friction knob and the crank; and

a friction plate coupled to the crank and the friction knob by the pin;

wherein rotation of the friction knob in turn rotates the pin which tightens the friction plate down onto the crank;

the delivery catheter comprises;

a handle having a longitudinal axis, a distal end, and a proximal end;

a delivery tube protruding out the distal end of the handle and aligned substantially along the longitudinal axis of the handle;

a first luer fitting attached to the proximal end of the handle;

a second luer fitting attached on the proximal end of the handle;

a proximal docking segment protruding out the distal end of the handle and encompassing the delivery tube;

a distal docking segment protruding out of the distal end of the handle and encompassing the delivery tube and the proximal docking segment;

a dual lumen composed of a first lumen and a second lumen, the first lumen is operatively connected to the first luer fitting, the second lumen is operatively connected to the second luer fitting, the dual lumen runs along the longitudinal axis of the handle up through the delivery tube;

a helical tip, attached to the delivery tube, for injecting a drug into the target site;

wherein when the delivery catheter is docked into the guide catheter the delivery tube is inserted within the guide tube, the distal docking segment is inserted into the first extension tube, the proximal docking segment is inserted into the second extension tube, and the shoulder limits the distance the delivery catheter inserts into the guide catheter.

4. A system for delivering a drug to a target site comprising a drug delivery catheter that docks onto a steerable guide catheter, wherein:

the steerable guide catheter comprises;

a housing composed of a top half and a bottom half, the housing having a longitudinal axis, a distal end, and a width;

a guide tube protruding out the distal end of the housing along the longitudinal axis of the housing;

a first extension tube located within the housing and substantially aligned with the longitudinal axis of the housing, the first extension tube is connected to the guide tube, the first extension having a diameter;

a second extension tube located within the housing and substantially aligned with the longitudinal axis of the housing, the second extension tube is connected to the first extension tube, the second tube having a diameter greater than the diameter of the first extension tube;

a shoulder created by the joining of the first extension tube with the second extension tube;

a steering knob, located outside the top half of the housing, for steering the guide tube, the steering knob having control levers with arms, the control levers extending radially beyond the width of the housing, the arms extending downward from the control levers to limit rotation of the steering knob;

a crank located within the housing, the crank is operatively connected to the steering knob such that rotation of the steering knob causes rotation of the crank;

a pullwire operatively connected to the crank such that rotation of the crank affects the tension on the pullwire;

a friction knob, located outside the bottom half of the housing, for increasing or decreasing the friction on the steering knob;

a pin operatively connected to the bottom half of the housing, the friction knob and the crank; and

a friction plate coupled to the crank and the friction knob by the pin;

wherein rotation of the friction knob in turn rotates the pin which tightens the friction plate down onto the crank;

the delivery catheter comprises;

a handle having a flattened portion, a longitudinal axis, a distal end, and a proximal end;

a delivery tube protruding out the distal end of the handle and aligned substantially along the longitudinal axis of the handle;

a first luer fitting attached to the proximal end of the handle;

a second luer fitting attached on the proximal end of the handle;

a proximal docking segment protruding out the distal end of the handle and encompassing the delivery tube;

a distal docking segment protruding out of the distal end of the handle and encompassing the delivery tube and the proximal docking segment;

a dual lumen composed of a first lumen and a second lumen, the first lumen is operatively connected to the first luer fitting, the second lumen is operatively connected to the second luer fitting, the dual lumen runs along the longitudinal axis of the handle up through the delivery tube; and

a helical tip, attached to the delivery tube, for injecting a drug into the target site;

wherein when the delivery catheter is docked into the guide catheter the delivery tube is inserted within the guide tube, the distal docking segment is inserted into the first extension tube, the proximal docking segment is inserted into the second extension tube, and the shoulder limits the distance the delivery catheter inserts into the guide catheter; and

wherein insertion of the delivery catheter into the guide catheter allows rotation of the delivery catheter handle to attach the helical tip to the target site.

5. A system for local drug delivery comprising a drug delivery catheter that docks onto a steerable guide catheter, wherein:

the steerable guide catheter comprises;

a housing composed of a top half and a bottom half, the housing having a longitudinal axis, a distal end, and a width;

a guide tube protruding out the distal end of the housing along the longitudinal axis of the housing;

a first extension tube centrally located within the housing and substantially aligned with the longitudinal axis of the housing, the first extension tube is connected to the guide tube, the first extension having a diameter;

a second extension tube centrally located within the housing and substantially aligned with the longitudinal axis of the housing, the second extension tube is connected to the first extension tube, the second tube having a diameter greater than the diameter of the first extension tube;

a shoulder created by the joining of the first extension tube with the second extension tube;

a steering knob, located outside the top half of the housing, for steering the guide tube, the steering knob having control levers with arms, the control levers extending radially beyond the width of the housing, the arms extending downward from the control levers to limit rotation of the steering knob;

a U-shaped crank located within the housing, the crank is operatively connected to the steering knob such that rotation of the steering knob causes rotation of the crank, the first extension tube passes through the U-shaped crank;

a pullwire operatively connected to the crank such that rotation of the crank affects the tension on the pullwire;

a friction knob, located outside the bottom half of the housing, for increasing or decreasing the friction on the steering knob;

a pin operatively connected to the bottom half of the housing, the friction knob and the crank; and

a friction plate coupled to the crank and the friction knob by the pin;

wherein rotation of the friction knob in turn rotates the pin which tightens the friction plate down onto the crank;

the delivery catheter comprises;

a handle having a flattened portion, a longitudinal axis, a distal end, and a proximal end;

a delivery tube protruding out the distal end of the handle and aligned substantially along the longitudinal axis of the handle;

a first luer fitting attached to the proximal end of the handle;

a second luer fitting attached on the proximal end of the handle;

a proximal docking segment protruding out the distal end of the handle and encompassing the delivery tube;

a distal docking segment protruding out of the distal end of the handle and encompassing the delivery tube and the proximal docking segment; and

a dual lumen composed of a first lumen and a second lumen, the first lumen is operatively connected to the first luer fitting, the second lumen is operatively connected to the second luer fitting, the dual lumen runs along the longitudinal axis of the handle up through the delivery tube;

wherein when the delivery catheter is docked into the guide catheter the delivery tube is inserted within the guide tube, the distal docking segment is inserted into the first extension tube, the proximal docking segment is inserted into the second extension tube, and the shoulder limits the distance the delivery catheter inserts into the guide catheter; and

wherein insertion of the delivery catheter into the guide catheter allows rotation of the delivery catheter handle.

6. A method for injecting a drug to a target site within a patient'"'"'s body, said method comprising the steps of:

inserting a steerable guide catheter into the patient'"'"'s body, the steerable guide catheter having a guide tube, a first extension tube, a second extension tube and a shoulder created by the joining of the first and second extension tubes;

directing the guide tube to the target site within the patient'"'"'s body;

providing a delivery catheter, the delivery catheter having a proximal docking segment, a distal docking segment, and a helical tip;

inserting a delivery catheter into the guide catheter such that the distal docking segment is inserted into the first extension tube and the proximal docking segment is inserted into the second extension tube, wherein the shoulder limits the distance the delivery catheter can be inserted into the guide catheter;

after inserting the delivery catheter into the guide catheter, rotating the delivery catheter to attach the helical tip to the target site; and

administering the drug to the target site through the helical tip.