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

• US 6,511,471 B2
• Filed: 12/22/2000
• Issued: 01/28/2003
• Est. Priority Date: 12/22/2000
• Status: Expired due to Term

• Current Assignee: Biocardia Deviceco, Inc.
• Original Assignee: BioCardia, Inc
• Inventors: Altman, Peter A., Rosenman, Daniel C., McEtchin, Douglas, Maston, Robert E., Kayser, Daniel J., Hakim, Brian K.
• Primary Examiner(s): Hirsch; Paul J.
• Application Number:
  US09/746,986
• Publication Number:
  US 20020082584A1
• Time in Patent Office: 767 Days
• Field of Search: 604/523,528,529
• US Class Current: 604/528
• 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 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 housing, for steering the guide tube; and

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 first 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 first lumen operatively connected to the luer fitting, the lumen running along the longitudinal axis of the handle 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 adapted to be inserted into the guide catheter, the delivery tube is adapted to be inserted within the guide tube, the distal docking segment is adapted to be inserted into the first extension tube, the proximal docking segment is adapted to be 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. The system of claim 2 wherein:

the steerable guide catheter further comprises;

a friction knob, disposed outside the housing, for increasing and decreasing the friction on the steering knob;

wherein the pin is further operatively connected to the friction knob;

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; and

the delivery catheter further comprises;

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

a second lumen operatively connected to the second luer fitting, the second lumen running along the longitudinal axis of the handle through the delivery tube.

4. The system of claim 3 wherein:

the steering knob of the steerable guide catheter has control levers with arms, the control levers extending radially beyond the width of the housing, and the arms extending downward from the control levers to limit rotation of the steering knob; and

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

5. The system of claim 4 wherein the crank of the steerable guide catheter is a U-shaped crank, and the first extension tube passes through the U-shaped crank.

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

providing a system for delivering a drug to a target site, said system comprising a drug delivery catheter that docks onto a steerable guide catheter, wherein;

the steerable guide catheter comprises;

a 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 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 first 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 first lumen operatively connected to the luer fitting, the lumen running along the longitudinal axis of the handle 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 adapted to be inserted into the guide catheter, the delivery tube is adapted to be inserted within the guide tube, the distal docking segment is adapted to be inserted into the first extension tube, the proximal docking segment is adapted to be inserted into the second extension tube, and the shoulder limits the distance the delivery catheter inserts into the guide catheter,

inserting the steerable guide catheter into the patient'"'"'s body;

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

inserting the 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.

7. The method of claim 6 further comprising the steps of:

further providing the steerable guide catheter with;

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; and

manipulating the crank to change the tension on the pullwire.

8. The method of claim 7 comprising the further steps of:

further providing the steerable guide catheter with;

a friction knob, disposed outside the housing, for increasing and decreasing the friction on the steering knob;

wherein the pin is further operatively connected to the friction knob;

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;

further providing the delivery catheter with;

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

a second lumen operatively connected to the second luer fitting, the second lumen running along the longitudinal axis of the handle through the delivery tube; and

manipulating the friction knob to tighten and loosen the friction plate on the crank.

9. The method of claim 8 comprising the further steps of:

further providing the steering knob of the steerable guide catheter with control levers, said control levers having arms, the control levers extending radially beyond the width of the housing, and the arms extending downward from the control levers to limit rotation of the steering knob;

inserting the delivery catheter into the guide catheter to allow rotation of the delivery catheter handle;

rotating the delivery catheter handle; and

using the control levers to limit the rotation of the steering knob.

10. The method of claim 9 comprising the further steps of:

further providing the crank of the steerable guide catheter with a U-shape; and

passing the first extension tube through the U-shaped crank.