Articulating suturing device with improved actuation and alignment mechanisms

• US 10,426,449 B2
• Filed: 02/16/2017
• Issued: 10/01/2019
• Est. Priority Date: 02/16/2017
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fortson, Aaron M.
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/434,907
• Publication Number:
  US 20180228478A1
• Time in Patent Office: 957 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

A vessel closure device that includes improved activation and alignment mechanisms that result in greater control and ease of use for the user.

Claims

1. An improved actuation and control mechanism intended for use in a vessel closure device for closing an opening or puncture in a vessel wall having an elongate shaft having a longitudinal axis, a housing positioned at the proximal end of the shaft, a flexible, atraumatic monorail guidebody positioned at the distal end of the shaft, a foot articulatably mounted proximate the distal end of the shaft, the foot being movable between a first, parked position, in which the foot is substantially aligned along the axis of the shaft, and a second, deployed position, in which the foot extends laterally away from the shaft, the foot having a first and a second end, the first end and the second end each having a needle receptacle with a cuff positioned therein, a length of suture located within the foot and extending between the cuffs, and a pair of needles located within the shaft that can be selectively advanced through the vessel wall adjacent to the opening and into the cuffs located in the needle receptacles in the first and second ends of the foot, and that can be selectively withdrawn thereby drawing the suture through the vessel wall adjacent to the opening, the improved actuation and control mechanism for the vessel closure device comprising:

a foot actuation handle operatively coupled to the foot, the foot actuation handle being selectively moveable linearly along the axis of the device between a distal position whereby the foot is positioned in its first, parked position, and a proximal position whereby the foot is positioned in its second, deployed position, the foot actuation handle comprising a pair of handles that extend laterally from opposing sides of the housing, and wherein the foot actuation handle is configured to be grasped and manipulated by a pair of fingers of one hand of a user; and

a needle actuation handle operatively coupled to the needles, the needle actuation handle being selectively movably linearly along the axis of the device between a proximal position wherein the needles are located within the shaft and a distal position wherein the needles are advanced to engage the cuffs, and wherein the needle actuation handle is configured to be engaged and selectively manipulated by a thumb of the same one hand of the user.

2. The vessel closure device of claim 1, wherein the foot is deployed by axial movement of the foot actuation handle in the proximal direction relative to the needle actuation handle.

3. The vessel closure device of claim 2, wherein, once the foot is deployed by proximal movement of the foot actuation handle, the needles are deployed into engagement with the foot by axial movement of the needle actuation handle in the distal direction relative to the foot actuation handle.

4. The vessel closure device of claim 1 further comprising a first interlock mechanism that prevents the needle actuation handle from being advanced from its proximal position when the foot is positioned in its first, parked position, but allows the needle actuation handle to be advanced from its proximal position to its distal position after the foot is moved to its second, deployed position.

5. The vessel closure device of claim 4, wherein the first interlock mechanism comprises:

a ball formed on a distal end of the needle actuation handle; and

a pair of projections formed on the housing and engaging opposing sides of the ball to constrain movement of the ball until a predetermined amount of pressure is applied to the needle actuation handle force the ball past the projection.

6. The vessel closure device of claim 5, wherein projections are flexible and resilient and are configured bend upon application of the predetermined amount of pressure applied to the needle actuation handle to allow movement of the ball in the distal direction.

7. The vessel closure device of claim 5, wherein projections are configured break upon application of the predetermined amount of pressure applied to the needle actuation handle to allow movement of the ball in the distal direction.

8. The vessel closure device of claim 1 further comprising a second interlock mechanism that temporarily locks the foot actuation handle into place when it is moved from its distal position to its proximal position.

9. The vessel closure device of claim 8 wherein the second interlock mechanism automatically releases the foot actuation handle from its proximal position after the needle actuation handle is returned to its proximal position from its distal position.

10. The vessel closure device of claim 9 further comprising a return bias spring associated with the foot actuation handle for biasing the foot actuation handle toward its distal position.

11. The vessel closure device of claim 10, wherein the second interlock mechanism comprises:

a pair of lock detents positioned on an inner surface of the foot actuation handle;

a pair of lock windows formed in opposing sides of the housing and positioned so as to receive the lock detents when the foot actuation handle is moved to its proximal position and thereby temporarily lock the foot actuation handle in its proximal position; and

a pair of flanges formed on an inner portion of the needle actuation handle, the flanges being configured to engage the lock detents and release the lock detents from the lock windows as the needle actuation handle is withdrawn from its distal position to its proximal position.

12. The vessel closure device of claim 1 further comprising one or more alignment marks positioned on an exterior surface of a distal end of the housing, each alignment mark being located at a pre-selected rotational position relative to the needles.

13. The vessel closure device of claim 12, wherein a first one of the one or more alignment marks is vertically aligned with the needles.

14. The vessel closure device of claim 13, wherein a second one of the one or more alignment marks is located at an angle of about 60 degrees in a clockwise direction relative to the first one of the one or more alignment marks.

15. The vessel closure device of claim 14, wherein a third one of the one or more alignment marks is located at an angle of about 60 degrees in a counter-clockwise direction relative to the first one of the one or more alignment marks.