Safety mechanism for an implantable device deployment apparatus

• US 9,526,645 B2
• Filed: 10/30/2012
• Issued: 12/27/2016
• Est. Priority Date: 10/31/2011
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Robinson, Thomas Patrick
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US13/664,234
• Publication Number:
  US 20130116771A1
• Time in Patent Office: 1,519 Days
• Field of Search: 623 111- 112
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

Systems and methods are disclosed for delivering a stent to a lumen internal to a body of a patient and for sheathing a stent just prior to an insertion procedure. One embodiment comprises a delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration. A panchor (combination pusher and anchor) is configured to engage and limit proximal and distal movement of the implantable device. An outer sheath surrounds a distal portion of an inner member and retains the implantable device near the distal end. The outer sheath is slidably moveable relative to the inner member to deploy the implantable device. Proximal movement of a trigger results in movement of the outer sheath to deploy the implantable device. A sheathing mechanism is configured to crimp and fully sheathe the implantable device prior to a deployment procedure.

Claims

1. A delivery system for sheathing a crimpable implantable device and deploying the implantable device within a body of a patient, the delivery system comprising:

a delivery device to position and deploy the implantable device, the delivery device having a tubular member configured to receive and house the implantable device in a crimped state for delivery to a target location within the body of the patient, the delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration, the tubular member comprising a first trigger safety notch and a second trigger safety notch; and

a safety mechanism removably engaged to the delivery device to limit operation of the delivery device and inhibit unintended deployment of the implantable device, the safety mechanism comprising an annular body with a deflectable tab including a first protrusion, the first protrusion extending inward relative to an inner surface of the annular body, wherein the safety mechanism, while engaged around the delivery device, is slidably moveable relative to the delivery device in a single direction from a first trigger safety position with the first protrusion engaging the first trigger safety notch to a second trigger safety position with the first protrusion causing a locking engagement at the second trigger safety notch to permit transition of the delivery device from the partially sheathed configuration at the first trigger safety position to the fully sheathed delivery configuration at the second trigger safety position during a sheathing process, wherein the locking engagement at the second trigger safety notch restricts slidable movement of the safety mechanism relative to the delivery device such that transition of the delivery device from the fully sheathed delivery configuration to the partially sheathed configuration and the deployed configuration at the second trigger safety position is restricted, and wherein the safety mechanism is removable from the delivery device to allow transition of the delivery device from the fully sheathed delivery configuration to the deployed configuration.

2. The delivery system of claim 1, wherein the annular body of the safety mechanism is further configured to restrict transition of the delivery device from the partially sheathed configuration to the deployed configuration to prevent premature full deployment of the implantable device in a partially sheathed state and before a sheathing process to fully sheathe the implantable device.

3. The delivery system of claim 1, wherein the safety mechanism is configured to provide an audible click to indicate that the delivery device has been transitioned to the fully sheathed delivery configuration and that the implantable device is fully sheathed.

4. The delivery system of claim 1, wherein the delivery device further comprises a trigger assembly coupled to the tubular member to facilitate deployment of the implantable device, wherein the safety mechanism is a trigger safety and the annular body comprises one or more radial protrusions configured to engage and limit operation of the trigger assembly of the delivery device.

5. The delivery system of claim 4, wherein the trigger assembly comprises a plurality of triggers, wherein the one or more radial protrusions of the annular body of the trigger safety limit proximal movement of the plurality of triggers, thereby inhibiting unintended deployment of the implantable device, while permitting distal movement of the plurality of triggers.

6. The delivery system of claim 5, wherein the tubular member of the delivery device comprises:

an inner member to couple to the implantable device in the partially sheathed configuration and the fully sheathed delivery configuration; and

an outer sheath coaxially surrounding at least a distal portion of the inner member, and having a distal portion configured to enclose the implantable device in the fully sheathed delivery configuration, wherein the outer sheath is slidably moveable relative to the inner member, and wherein proximal movement of the outer sheath relative to the inner member deploys the implantable device, wherein the trigger assembly is configured to move the outer sheath proximally relative to the inner member to withdraw the implantable device from the tubular member.

7. The delivery system of claim 6, wherein the trigger assembly further comprises an internal connector bonded to the outer sheath,

wherein the plurality of triggers couple to the internal connector,

wherein the trigger safety engages the internal connector to limit operation of the trigger assembly.

8. The delivery system of claim 6,

wherein the delivery device further comprises one or more elongate outer supports configured to support the trigger assembly, including the plurality of triggers,

wherein the trigger safety engages the one or more outer supports to limit operation of the trigger assembly.

9. The delivery system of claim 8, wherein the one or more outer supports define one or more trigger safety notches configured to be engaged by the trigger safety to limit proximal movement of the plurality of triggers.

10. The delivery system of claim 1, wherein the annular body is configured to, in a closed configuration, encircle and engage the delivery device and configured to transition to an open configuration to disengage from the delivery device.

11. The delivery system of claim 10, wherein the safety mechanism further comprises a release tab for opening the annular body to transition the annular body from the closed configuration to the open configuration and to disengage the annular body from the delivery device and thereby release the safety mechanism.

12. The delivery system of claim 10, wherein the annular body comprises a hinge configured to allow the annular body to open to the open configuration and to disengage from the delivery device.

13. The delivery system of claim 10, wherein the annular body further comprises a second protrusion disposed on an inner surface of the annular body, wherein the second protrusion

is configured to restrict movement of an outer sheath of the tubular member of the delivery device relative to the safety mechanism when the annular body is in the closed configuration around the delivery device.