Medical device introducer and obturator and methods of use

• US 7,427,287 B2
• Filed: 03/03/2005
• Issued: 09/23/2008
• Est. Priority Date: 11/12/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences (Edwards Lifesciences Corporation)
• Inventors: Turovskiy, Roman, Murphy, Richard O.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US11/071,624
• Publication Number:
  US 20050177188A1
• Time in Patent Office: 1,300 Days
• Field of Search: 606/200, 606/184, 606/185, 606/153, 606/127, 128/898, 600/37, 604/264, 604/500, 604/533, 604/535, 604/164.11, 604/167.06, 604/165.04, 604/164.01, 623/1.11, 623/1.12, 623/1.24, 623/1.26
• US Class Current: 606/185
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal

Abstract

An introducer having an elongate tubular member and a device connector releasably attached to a proximal end of the tubular member. The introducer allows exchange of medical instruments, such as a blood filter and cardioplegia catheter, through a single lumen. An obturator having a retractable blade for making incision on a tissue is insertable through the lumen of the introducer. Methods of using the obturator and the introducer for introducing medical device(s) into body cavity, such as a vessel or cardiac tissue, are also disclosed.

Claims

1. A method for introducing a medical device during cardiovascular surgery, comprising the steps of:

providing an elongate tubular member having a proximal end, a distal end, and a lumen therebetween, the distal end adapted to enter a vessel or cardiac tissue, wherein said providing an elongate tubular member further comprises providing an elongate tubular member having a slot in the distal end which extends proximally;

a blade mounted within the slot at the distal end of the elongate tubular member; and

an actuating mechanism having a distal end connected to a proximal end of the blade, and a proximal end operable from the proximal end of the elongate tubular member, the actuating mechanism further comprising a force biasing element, a rotary element, a retaining element, and a release;

providing a device connector having a first end, a second end, and a lumen therebetween, the device connector configured to receive a medical device, the device connector further being shaped to engage the proximal end of the elongate tubular member;

engaging a medical device in the lumen of the device connector;

inserting the elongate tubular member through an incision into the vessel or cardiac tissue;

inserting the medical device into the lumen of the elongate tubular member and advancing the medical device into the vessel or cardiac tissue; and

after engaging the medical device in the lumen of the device connector, engaging the device connector to the proximal end of the elongate tubular member,

wherein said method further comprises making an incision into the vessel or cardiac tissue by activating the blade by advancing the actuating mechanism of the elongate tubular member.

2. The method of claim 1, wherein said making an incision comprises applying a force to the release which slideably rotates the rotary element to disengage the release, causing the blade to advance beyond the slot and applying a force distally to the release, which slideably rotates the rotary element to engage the release, causing the blade to refract into the slot.

3. A method for introducing a medical device during cardiovascular surgery, comprising the steps of:

providing an elongate tubular member having a proximal end, a distal end, and a lumen therebetween, the distal end adapted to enter a vessel or cardiac tissue, the proximal end having a first alignment mechanism, wherein said providing an elongate tubular member further comprises providing an elongate tubular member having a slot in the distal end which extends proximally;

a blade mounted within the slot at the distal end of the elongate tubular member; and

an actuating mechanism having a distal end connected to a proximal end of the blade, and a proximal end operable from the proximal end of the elongate tubular member, the actuating mechanism further comprising a force biasing element, a rotary element a retaining element and a release;

providing a device connector having a first end a second end and a lumen therebetween, the device connector configured to receive the medical device, and being shaped to engage the proximal end of the elongate tubular member, the second end having a second alignment mechanism;

engaging a medical device in the lumen of the device connector;

inserting the elongate tubular member through an incision into the vessel or cardiac tissue;

inserting the medical device into the lumen of the elongate tubular member and advancing the medical device into the vessel or cardiac tissue;

aligning the device connector second alignment mechanism with the elongate tubular member first alignment mechanism; and

engaging the device connector to the proximal end of the elongate tubular member, wherein the first alignment mechanism and the second alignment mechanism cooperate so as to prevent torsional movement of the elongate tubular member in relation to the device connector,

wherein said method further comprises making an incision into the vessel or cardiac tissue by activating the blade by advancing the actuating mechanism of the elongate tubular member.

4. The method of claim 3, wherein said making an incision comprises applying a force to the release which slideably rotates the rotary element to disengage the release, causing the blade to advance beyond the slot and applying a force distally to the release, which slideably rotates the rotary element to engage the release, causing the blade to refract into the slot.

5. A method for introducing a medical device during cardiovascular surgery, comprising the steps of:

providing an elongate tabular member having a proximal end a distal end, and a lumen therebetween, the distal end adapted to enter a vessel or cardiac tissue wherein said providing an elongate tubular member further comprises providing an elongate tubular member having a slot in the distal end which extends proximally;

a blade mounted within the slot at the distal end of the elongate tubular member; and

an actuating mechanism having a distal end connected to a proximal end of the blade, and a proximal end operable from the proximal end of the elongate tubular member, the actuating mechanism further comprising a force biasing element, a rotary element, a retaining element, and a release;

providing a device connector having a first end, a second end, and a lumen therebetween, the device connector configured to receive the medical device, and being shaped to engage the proximal end of the elongate tubular member by operation of a release mechanism;

engaging a medical device in the lumen of the device connector;

inserting the elongate tubular member through an incision into the vessel or cardiac tissue;

inserting the medical device into the lumen of the elongate tubular member and advancing the medical device into the vessel or cardiac tissue; and

engaging the device connector to the proximal end of the elongate tubular member, wherein the release mechanism is engaged to prevent longitudinal movement of the device connector relative to the elongate tubular member; and

disengaging the medical device from the elongate tubular member via the release mechanism such that the device connector and medical device are removed from the elongate member;

wherein said method further comprises making an incision into the vessel or cardiac tissue by activating the blade by advancing the actuating mechanism of the elongate tubular member.

6. The method of claim 5, wherein said making an incision comprises applying a force to the release which slideably rotates the rotary element to disengage the release, causing the blade to advance beyond the slot and applying a force distally to the release, which slideably rotates the rotary element to engage the release, causing the blade to refract into the slot.