Catheter device and method for delivering a dose internally during minimally-invasive surgery

• US 7,488,305 B2
• Filed: 08/09/2004
• Issued: 02/10/2009
• Est. Priority Date: 06/17/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Connell, Jeremy L., Christie, Bruce Arthur, Walker, Douglas F., Mickley, Timothy J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US10/913,520
• Publication Number:
  US 20050020986A1
• Time in Patent Office: 1,646 Days
• Field of Search: 604/158, 604/164.01, 604/164.12, 604/165.01, 604/246, 604/131, 604134-136, 604/151, 604156-157, 604/181, 604207-211, 604/186
• US Class Current: 604/164.12
• 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 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

A catheter handpiece apparatus and method for delivering a desired dose with minimal potential for contamination of the injected substance and rapid, accurate delivery of the desired dose. In one embodiment, a carriage assembly affixed to an inner lumen is slidably located within a handpiece housing equipped with an outer lumen. The carriage assembly receives a dose carpule. An actuator knob cocks the carriage assembly and a spring-powered actuator mechanism. After the catheter is maneuvered to a desired injection site and a desired dose is set, depressing a first trigger causes the inner lumen tip to extend beyond the outer lumen into the injection site. Depressing a second trigger causes the actuator mechanism to push the desired dose from the dose carpule through the inner lumen into the injection site. A second embodiment provides a catheter handpiece with a carriage assembly cocking lever and an operator-powered dose delivery mechanism.

Claims

1. A dose delivery device for delivering a desired dose to an injection site within a patient'"'"'s body, comprising:

a housing;

a carriage assembly located within the housing, the carriage assembly sized to accept a removable carpule of therapeutic and movable from a retracted position to an advanced position;

a first lumen in fluid communication with the carriage assembly;

a carpule of therapeutic positioned in the carriage assembly, the carpule of therapeutic removable from the carriage assembly, therapeutic within the carpule being releasable from the carpule into the first lumen;

a dose delivery actuator; and

a dose metering member operable from outside the housing, the dose metering member having a first position and a second position different from said first position;

wherein the dose delivery actuator has a starting position, a first stopped position in which said dose delivery actuator is engaged with said dose metering member when said dose metering member is in its first position, and a second stopped position in which said dose delivery actuator is engaged with said dose metering member when said dose metering member is in its second position;

wherein when the dose metering member is in its first position and the dose delivery actuator is actuated from its starting position, the dose delivery actuator moves from its starting position to its first stopped position, applying a force to the carpule to eject a first desired dose; and

wherein when the dose metering member is in its second position and the dose delivery actuator is actuated from its starting position, the dose delivery actuator moves from its starting position to its second position, applying a force to the carpule to eject a second desired dose different than the first desired dose.

2. The dose delivery device of claim 1 further comprising:

a second lumen, the second lumen surrounding the first lumen, the second lumen coupled to a strain relief portion of the housing.

3. The dose delivery device of claim 2, wherein first lumen is slidable within the second lumen.

4. The dose delivery device of claim 1 wherein the housing further comprises a dose delivery trigger.

5. The dose delivery device of claim 1 wherein the housing includes a sliding member movable between an open position and a closed position, the sliding member providing access to an internal area within the housing when the member is in an open position.

6. The dose delivery device of claim 1 further comprising a dose scale readable to indicate the dosage to be delivered by the dose delivery device, the dose metering member acting as a pointer for the dose scale.

7. The dose delivery device of claim 1, wherein the first lumen is affixed to the carriage assembly and movable with the carriage assembly such that when the carriage assembly is in its retracted position the first lumen is also in a retracted position and when the carriage assembly is in its advanced position the first lumen is also in an advanced position.

8. The dose delivery device of claim 1, further comprising:

an outer lumen, a proximal end of which is affixed to a lumen end of the housing, the first lumen slidably located within the outer lumen, wherein a proximal end of the first lumen is affixed to a lumen end of the carriage assembly and a distal end of the first lumen extends beyond a distal end of the outer lumen when the carriage assembly slides toward the lumen end of the housing;

at least one cocking member for placing the carriage assembly into a cocked condition; and

a carriage assembly release trigger;

wherein the carriage assembly when released from its cocked condition by the carriage assembly release trigger is biased to slide toward the lumen end of the housing, thereby extending a distal end of the first lumen beyond a distal end of the outer lumen.

9. The dose delivery device of claim 8 wherein a spring biases the carriage assembly toward the lumen end of the housing.

10. The dose delivery device of claim 8 wherein the carriage assembly is slidable from its cocked condition in which it is in a retracted position to an advanced position, wherein when the carriage assembly is its retracted position the first lumen is also in a retracted position and when the carriage assembly is in its advanced position the first lumen is also in an advanced position extending beyond a distal end of the outer lumen.

11. A dose delivery device for delivering a desired dose to an injection site within a patient'"'"'s body, comprising:

a housing;

a first lumen;

a carpule of therapeutic positioned in the housing, therapeutic within the carpule being releasable from the carpule into the first lumen;

a dose delivery actuator comprising a rotatable member and a longitudinally movable member in threaded engagement with the rotatable member;

at least one cocking member for placing the dose delivery actuator into a cocked condition;

a dose metering member operable from outside the housing; and

a dose release trigger;

wherein the rotatable member has a starting position when the dose delivery actuator is in its cocked condition and a first stopped position in which said rotatable member is rotated from its starting position, and the longitudinally movable member has a starting position when the dose delivery actuator is in its cocked condition and a first stopped position in which said longitudinally movable member is longitudinally translated from its starting position;

wherein the dose delivery actuator when released from its cocked condition by the dose release trigger is biased to cause the rotatable member to rotate from its starting position, which in turn causes the longitudinally movable member to move longitudinally from its starting position to apply a force to the carpule to eject a desired dose into the first lumen, and wherein dose delivery actuator movement is halted by the dose metering member when the desired dose has been delivered.

12. The dose delivery device of claim 11, wherein the dose delivery actuator comprises a dose delivery actuator spring;

wherein the rotatable member comprises an actuator tube rotatable to a cocked condition by actuation of the cocking member;

wherein actuation of the cocking member causes rotation of the actuator tube to the cocked condition, thereby storing energy in the dose delivery actuator spring; and

wherein actuation of the dose release trigger releases the actuator tube from the cocked condition, thereby allowing the actuator tube to rotate and causing the dose delivery actuator to apply a force to the carpule to eject a desired dose into the first lumen.

13. The dose delivery actuator of claim 12, wherein the dose delivery actuator includes a dose stop tab on the actuator tube which cooperates with the dose metering member to halt actuator tube rotation when the desired dose has been delivered.

14. The dose delivery device of claim 12,

wherein the longitudinally movable member comprises a dose delivery actuator rod;

wherein the rotatable member further comprises an actuator drive nut; and

wherein when the actuator tube rotates in response to actuation of the dose release trigger, the actuator nut rotates with the actuator tube and causes the dose delivery actuator rod to advance against the dose carpule until actuator tube rotation is halted by the dose metering member.

15. A dose delivery device for delivering a desired dose to an injection site within a patient'"'"'s body, comprising:

a housing;

a first lumen; and

a dose delivery actuator having a starting position and a first stopped position, the dose delivery actuator comprising a rotatable member and a longitudinally movable member in engagement with the rotatable member;

wherein the rotatable member has a starting position when the dose delivery actuator is in its starting position and a first stopped position in which said rotatable member is rotated from its starting position, and the longitudinally movable member has a starting position when the dose delivery actuator is in its starting position and a first stopped position in which said longitudinally movable member is longitudinally translated from its starting position;

wherein the dose delivery actuator when moved from is starting position to its first stopped position causes the rotatable member to rotate from its starting position to its first stopped position, which in turn causes the longitudinally movable member to move longitudinally from its starting position to its first stopped position to eject a desired dose of therapeutic agent from the first lumen.

16. The dose delivery device of claim 15,

wherein the rotatable member comprises an actuator nut;

wherein the longitudinally movable member comprises a dose delivery actuator rod;

wherein the actuator nut is in threaded engagement with the dose delivery actuator rod; and

wherein rotation of the actuator nut causes the dose delivery actuator rod to move longitudinally to eject a desired dose of therapeutic agent from the first lumen.

17. The dose delivery device of claim 15,

wherein the rotatable member comprises an actuator tube, an actuator nut, and ratchet teeth for selective engagement between the actuator tube and actuator nut, wherein rotation of the actuator tube in a first direction to the starting position does not cause rotation of the actuator nut, wherein rotation of the actuator tube in a second direction away from the starting position does cause rotation of the actuator nut;

wherein the longitudinally movable member comprises a dose delivery actuator rod;

wherein the actuator nut is in threaded engagement with the dose delivery actuator rod;

wherein when the dose delivery actuator is actuated from its starting position, the actuator tube rotates in the second direction away from the starting position, causing rotation of the actuator nut, and thereby causing the dose delivery actuator rod to move longitudinally to eject a desired dose of therapeutic agent from the first lumen; and

wherein when the dose delivery actuator is returned to its staffing position, the actuator tube rotates in the first direction to the starting position, while the actuator nut does not rotate and the dose delivery actuator rod does not move longitudinally.

18. The dose delivery device of claim 15, further comprising:

at least one cocking member for placing the dose delivery actuator into a cocked condition; and

a dose release trigger;

wherein the dose delivery actuator comprises a dose delivery actuator spring;

wherein the rotatable member is rotatable to a cocked condition by actuation of the cocking member;

wherein actuation of the cocking member causes rotation of the rotatable member in a first rotation direction to the cocked condition, thereby storing energy in the dose delivery actuator spring; and

wherein actuation of the dose release trigger releases the rotatable member from the cocked condition, thereby allowing the rotatable member to rotate in a second rotation direction opposite to the first rotation direction and causing the longitudinally movable member to eject a desired dose of therapeutic agent from the first lumen.

19. A dose delivery device for delivering a desired dose to an injection site within a patient'"'"'s body, comprising:

a housing;

a first lumen;

a dose delivery actuator; and

a dose metering member operable from outside the housing, the dose metering member having a first position and a second position different from said first position;

wherein the dose delivery actuator has a starting position, a first stopped position in which said dose delivery actuator is engaged with said dose metering member when said dose metering member is in its first position, and a second stopped position in which said dose delivery actuator is engaged with said dose metering member when said dose metering member is in its second position;

wherein when the dose metering member is in its first position and the dose delivery actuator is actuated from its starting position, the dose delivery actuator moves from its starting position to its first stopped position, ejecting a first desired dose; and

wherein when the dose metering member is in its second position and the dose delivery actuator is actuated from its starting position, the dose delivery actuator moves from its starting position to its second stopped position, ejecting a second desired dose different than the first desired dose.