Drug delivery module

• US 6,183,444 B1
• Filed: 05/16/1998
• Issued: 02/06/2001
• Est. Priority Date: 05/16/1998
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Corporation, Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: MicroHeart, Inc. (Boston Scientific Corporation)
• Inventors: Glines, Robert C., Brown, Daniel S., Phipps, Richard D., Lundquist, Lauren
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US09/080,175
• Time in Patent Office: 997 Days
• Field of Search: 606/104, 606/114, 604/131, 604/134-138, 604/144, 604/151, 604/152, 604/181, 604/187, 604/191, 604/197, 604/207, 604/208-211, 604/218, 604/232, 604/234
• US Class Current: 604/187
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• 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 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 5/31531 Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

A modular drug delivery system for use by cardiothoracic surgeons and interventional cardiologists for delivery of molecular and cellular therapies that target genes, molecules and peptides. The regulated drug delivery devices comprise a modular mechanically actuated drug delivery module (DDM) that can be attached to either a surgical viewing endoscope hand-piece or specialized catheter for interventional procedures. The DDM provides metering of drugs to treatment sites and allows for quick interchangeability with other component parts such as a viewing scope end portion for MIS or other surgical procedures or a flexible catheter shaft for percutaneous procedures.

Claims

1. A drug delivery device for medicating internal tissue during minimally invasive surgery and/or other surgical procedures, the device comprising:

(a) a drug delivery needle having a piercing tip and attached to a distal end of a drug conduit, the drug conduit also having a proximal end; and

(b) a detachable drug delivery module for metering the drug, the detachable drug delivery module including;

(i) a housing having a quick-disconnect interface for coupling to said drug conduit;

(ii) at least one drug reservoir communicating with the drug conduit, the at least one reservoir mounted within the housing; and

(iii) an actuating means for (1) advancing the drug delivery needle, (2) displacing drug from the at least one reservoir through the drug delivery needle via the drug conduit, and (3) retracting the drug delivery needle, the actuating means also mounted within the housing;

(c) a body member at the proximal end of said drug conduit, said body member adapted for connecting a visualization scope thereto, the body member being attached to the housing; and

(d) an introducer having a length sufficient to reach a treatment site at target tissue, the introducer defining a working channel wherein the advanceable drug delivery needle with attached drug conduit is disposed therein, the piercing tip of the drug delivery needle being egressable at the introducer'"'"'s distal end.

2. The device of claim 1 which further comprises a rigid endoscope having a visualization scope, the introducer further including:

(i) a rigid tubular member that slidably encompasses the endoscope; and

(ii) a transparent distal tip member that encloses the tubular member'"'"'s distal end, said tip member enabling visualization of the working channel'"'"'s distal end.

3. The device of claim 2, wherein the tubular member and the transparent distal tip member form a unitary member made of an optically transparent polymer material, the unitary member having a uniform wall thickness.

4. The device of claim 2, wherein the endoscope'"'"'s distal end is essentially normal to the axis of the introducer, thereby providing visualization in a forward direction, and the working channel directs the piercing tip of the drug delivery needle past the introducer'"'"'s distal end at an angle essentially parallel to the introducer.

5. The device of claim 2, wherein the endoscope'"'"'s distal end is essentially normal to the axis of the introducer, thereby providing visualization in a forward direction, and the working channel directs the piercing tip of the drug delivery needle past the introducer'"'"'s distal end at an angle to the introducer.

6. The device of claim 2, wherein the endoscope'"'"'s distal end is at an angle with respect to an axis of the introducer, thereby providing visualization in a direction at an angle to the axis of the introducer, and the working channel directs the piercing tip of the drug delivery needle past the introducer'"'"'s distal end in a direction essentially parallel to the axis of the introducer.

7. The device of claim 2, wherein the endoscope'"'"'s distal end is at an angle with respect to an axis of the introducer, thereby providing visualization in a direction at an angle to the axis of the introducer, and the working channel directs the piercing tip of the drug delivery needle past the introducer'"'"'s distal tip at an angle to the axis of the introduce.

8. A drug delivery device for medicating internal body tissue during catheter and/or other percutaneous procedures, the device comprising:

(a) a drug delivery needle having a piercing tip, said needle being attached to a distal end of a drug conduit, the drug conduit also having a proximal end; and

(b) a detachable drug delivery module for metering the drug, the detachable drug delivery module including;

(i) a housing having a quick-disconnect interface for coupling to said drug conduit;

(ii) at least one drug reservoir communicating with the drug conduit, the at least one reservoir mounted within the housing; and

(iii) actuating means for (1) advancing the drug delivery needle, (2) displacing drug from the at least one reservoir through the drug delivery needle via the drug conduit, and (3) retracting the drug delivery needle, the actuating means mounted within the housing;

(c) an introducer having a length sufficient to reach a treatment site at target tissue, the introducer being attached to the quick-disconnect interface, the introducer defining at least one working channel in which said drug delivery needle and said drug conduit are disposed, the piercing tip of the drug delivery needle being egressable at the introducer'"'"'s distal end.

9. A detachable drug delivery module kit for visualizing and medicating internal body tissue during MIS and other surgical procedures and for catheter and/or percutaneous procedures, the kit comprising:

(a) a drug delivery needle having a piercing tip, said needle being attached to a distal end of a drug conduit, the drug conduit also having a proximal end; and

(b) a detachable drug delivery module for metering the drug, the detachable drug delivery module including;

(i) a housing having a quick-disconnect interface for coupling to said drug conduit;

(ii) at least one drug reservoir communicating with the drug conduit, the at least one reservoir mounted within the housing; and

(iii) actuating means for (1) advancing the drug delivery needle, (2) displacing drug from the at least one reservoir through the drum delivery needle via the drug conduit, and (3) retracting the drug delivery needle, the actuating means also mounted within the housing;

(c) a visualization scope having a body member for attachment to said housing, said visualization scope including a viewing means for optical viewing at the distal end of the drug conduit;

(d) an endoscope-type introducer having a length sufficient to reach a treatment site, the endoscope-type introducer defining a working channel in which said drug delivery needle and said drug conduit are disposed, the piercing tip of the drug delivery needle being egressable at the endoscope-type introducer'"'"'s distal end; and

(e) a catheter introducer having a length sufficient to reach a treatment site, the catheter introducer defining a working channel in which said drug delivery needle and said drug conduit are disposed, the piercing tip of the drug delivery needle being egressable at the catheter introducer'"'"'s distal end.