Drug delivery module

• US 6,309,375 B1
• Filed: 05/18/1999
• Issued: 10/30/2001
• Est. Priority Date: 05/16/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: MicroHeart, Inc. (Boston Scientific Corporation)
• Inventors: Brown, Daniel S., Glines, Robert C., Lundquist, Lauren K., Phipps, Richard D.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/314,459
• Time in Patent Office: 896 Days
• Field of Search: 604/207, 604/187, 604/131, 604/134, 604/135, 604/136, 604/138, 604/137, 604/144, 604/151, 604/152, 604/181, 604/191, 604/197, 604/208, 604/209, 604/210, 604/211, 604/218, 604/232, 604/234, 604/240, 606/104, 606/114
• 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. Apparatus for delivery of a drug solution to a target site within a subject by needle injection, comprising

(a) a delivery device having (i) a housing, (ii) a fluid reservoir, (iii) a carriage assembly mounted in said housing for movement between retracted and extended conditions, and (iv) an actuator assembly operatively connected to said carriage and said reservoir, to cause movement of said carriage from its retracted toward its extended position, and cause flow of fluid from said reservoir, as said actuator is moved from open to closed positions, and

(b) an appliance maneuverable within a subject to such target site, said appliance having an elongate hollow body probe defining a length having proximal and distal ends, and an inner lumen extending therebetween, an extension member extending substantially said length of said probe from said proximal probe end to said distal probe end, and a needle carried at said distal probe end of said extension member,

wherein said extension member is operatively connected to said carriage, and said needle is in fluid communication with said reservoir, such that (i) movement of said carriage assembly from its retracted to its extended position is transmitted through said extension member to said needle at said distal probe end, causing said needle to move from a retracted position to an injection position into said target site, and (ii) fluid contained in said reservoir is forced from said reservoir through said needle and delivered into said target site.

2. The apparatus of claim 1, wherein said actuator assembly includes (i) an actuator mounted on said housing for movement between open and closed positions, (ii) advancing means operatively connecting said actuator to said carriage assembly, to advance said carriage assembly toward its extended position when said actuator is moved away from its open position, toward its closed position, and (iii) compressing means operatively connecting said actuator to said reservoir for compressing said reservoir when said actuator is moved from its open position, toward its closed condition.

3. The apparatus of claim 2, wherein said advancing means is effective to advance said carriage assembly toward its extended position when said actuator is moved from its open position, toward a position intermediate its open position and closed position, and said compressing means is effective to compress said reservoir when said actuator is moved from a position intermediate its open position and closed position toward its closed position.

4. The device of claim 2, wherein said reservoir is contained in said housing, and is a syringe barrel having an outlet in fluid communication with said needle, and said compressing means includes a plunger movable within said barrel toward said outlet, to expel fluid from said reservoir.

5. The apparatus of claim 4, wherein said actuator includes a handle operable between said open and closed positions, and a pivoting member mounted in said housing for pivoting movement in forward and reverse directions as said actuator is moved between open and closed positions, respectively, and said compressing means further includes (a) a sliding bar operatively engageable at one bar end with said plunger, (b) a reciprocating bar connected at one bar end to said pivoting member, for movement in forward and reverse directions as said pivoting member is pivoted in forward and reverse directions, respectively, and (c) a releasable locking mechanism operably coupling said sliding bar and reciprocating bar, such that successive actuations of said actuator are effective to advance said sliding bar incrementally in a forward direction effective to expel a defined and incremental quantity of fluid from said reservoir with each such actuation.

6. The apparatus of claim 5, wherein said locking mechanism includes first and second pivot plates, said first plate being operatively connected to said reciprocating bar, and adapted to engage or release said sliding bar, as said reciprocating bar is advanced in a forward or reverse direction, respectively;

and said second plate being pivotally mounted adjacent said sliding bar, and adapted to release or engage said sliding bar as said reciprocating bar is advanced in a forward or reverse direction, respectively.

7. The apparatus of claim 2, wherein said actuator includes a manually operable handle operable between said open and closed positions, and a pivoting member mounted in said housing for pivoting movement in forward and reverse directions, as said actuator is moved toward and away from its closed position, respectively, and said advancing means is (i) a sliding surface contact between said pivoting member and said carriage assembly, or (ii) a two-condition spring interposed between said pivoting member and carriage assembly, effective to flip from one condition to another, when a selected spring tension is reached, to move said carriage toward its extended position.

8. The apparatus of claim 2, wherein said carriage assembly includes a carriage and a conduit attached thereto, and in fluid communication with said reservoir, and said extension member is a hollow tube in fluid communication with said conduit, for transmitting fluid pressure from said reservoir to said needle.

9. The apparatus of claim 8, wherein drug solution is contained in said distal end of said tube.

10. The apparatus of claim 8, wherein drug solution is contained in a drug container adjacent said distal end of said appliance, and fluid pressure transmitted from said reservoir through said tube is effective to drive drug solution from said container through said needle.

11. The apparatus of claim 2, wherein said carriage assembly includes a carriage and a linkage attached thereto, and said extension is a wire member operatively connected to said linkage, and said device further includes a fluid-carrying tube for transmitting fluid pressure from said reservoir to said needle.

12. The apparatus of claim 1, wherein said appliance is a catheter assembly, and said probe is a hollow catheter sleeve.