Method and apparatus for loading and implanting a shape memory implant

Inventors

Taber, Joseph H.Knight, Adam T.Marcano, Eric A.

Assignees

Biomedical Enterprises Inc

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Publication Number

US-9585656-B2

Patent

Publication Date

2017-03-07

Expiration Date


Abstract

An implant insertion system includes a shape memory implant movable between a first shape a second shape and an implant insertion device movable between an implant disengagement position and an implant engagement position. The implant insertion device receives the shape memory implant in its first shape while in its implant disengagement position. Movement of the implant insertion device from its implant disengagement position to its implant engagement position manipulates the shape memory implant from its first shape to its second shape. The implant insertion device maintains the shape memory implant in its second shape until delivery of the shape memory implant into tissue or bone.

Core Innovation

The disclosed invention relates to an implant insertion device and implant insertion system for moving a shape memory implant from a first shape to a second shape and maintaining the shape memory implant in the second shape until delivery of the shape memory implant into tissue or bone. The device includes a body with a first arm including a first jaw and a second arm including a second jaw, where the first jaw and the second jaw are movable from a disengaged position to an engaged position. A spacer is coupled with the body and movable between an unlocked position and a locked position, and in the spacer’s locked position the spacer inserts between the first jaw and the second jaw to urge the first and second jaws to their engaged positions.

When urged to their engaged positions, the first and second jaws engage the shape memory implant and move the shape memory implant from its first shape to its second shape. The jaws in their engaged positions maintain the shape memory implant in the second shape. In the described system, the implant insertion device is adapted to receive the shape memory implant in its first shape, manipulate the shape memory implant from its first shape to its second shape, and maintain the shape memory implant in its second shape for packaging loaded with the shape memory implant in its second shape.

The disclosed device and system further address delivery and release, where the shape memory implant is delivered into tissue or bone and then the spacer moves from the locked position to the unlocked position, releasing the spacer between the first and second jaws so the jaws disengage the implant. After removal of the implant insertion device from the shape memory implant, the shape memory implant moves from its second shape to its first shape, thereby securing the first bone, bone fragment, or tissue with the second bone, bone fragment, or tissue. The disclosed loading and maintaining concepts include reducing the shape memory implant to a temperature at or below a deformation temperature of the shape memory implant prior to moving the spacer to its locked position and maintaining the implant in the second shape.

Claims Coverage

The partial content includes five independent claims (device, system, securing method, loading method for a device, and loading method for a plurality). Across these independent claims, the core inventive features are: (1) a two-jaw insertion device with a movable spacer that inserts between jaws in a locked position to urge jaw engagement and shape transformation, (2) maintaining the implant in the second shape for packaging and until delivery into tissue or bone, and (3) releasing the implant by moving the spacer back to an unlocked position and disengaging the jaws so the implant can return to the first shape, with loading methods that include temperature reduction relative to a deformation temperature and, in some variants, press-tool based spacer locking.

Shape memory implant insertion device with two jaws and spacer-driven engagement

An implant insertion device having a body with a first arm including a first jaw and a second arm including a second jaw, where the first and second jaws are movable from a disengaged position to an engaged position; and a spacer coupled with the body and movable between an unlocked position and a locked position such that, in its locked position, the spacer inserts between the first jaw and the second jaw and urges the first and second jaws to their engaged positions to engage the shape memory implant and move the shape memory implant from its first shape to its second shape, while the first and second jaws in their engaged positions maintain the shape memory implant in the second shape.

Shape memory implant insertion system maintaining second shape for packaging

An implant insertion system comprising a shape memory implant movable between a first shape and a second shape; and an implant insertion device adapted to receive the shape memory implant in its first shape, manipulate the shape memory implant from its first shape to its second shape, and maintain the shape memory implant in its second shape such that the implant insertion device is adapted for packaging loaded with the shape memory implant in its second shape; the implant insertion device further including a body with first and second arms having first and second jaws movable from a disengaged position to an engaged position, and a spacer movable between an unlocked position and a locked position where, in the locked position, the spacer inserts between the first and second jaws to urge them into engaged positions to engage the shape memory implant, move it from the first shape to the second shape, and maintain it in the second shape.

Securing first bone, bone fragment, or tissue via spacer release and return from second shape

A method of securing a first bone, bone fragment, or tissue with a second bone, bone fragment, or tissue comprising providing a shape memory implant movable between a first shape and a second shape; contacting first and second jaws of an implant insertion device with the shape memory implant in its first shape; moving a spacer from an unlocked position to a locked position so the spacer inserts between the first and second jaws to urge the first and second jaws to engage the shape memory implant and move it from its first shape to its second shape, with the first and second jaws maintaining the shape memory implant in the second shape; positioning the bones/tissue relative to each other and positioning the shape memory implant using the implant insertion device; inserting the shape memory implant into the first bone/bone fragment/tissue and the second bone/bone fragment/tissue using the implant insertion device; moving the spacer from between the first jaw and the second jaw to release the shape memory implant from the first and second jaws; and removing the implant insertion device such that the shape memory implant moves from its second shape to its first shape, thereby securing the first bone/bone fragment/tissue with the second bone/bone fragment/tissue.

Loading an implant insertion device by cooling to deformation temperature and spacer locking

A method of loading an implant insertion device with a shape memory implant comprising providing a shape memory implant movable between a first shape and a second shape; contacting first and second jaws of an implant insertion device with the shape memory implant in its first shape; reducing the shape memory implant to a temperature at or below a deformation temperature of the shape memory implant; and moving a spacer of the implant insertion device from an unlocked position to a locked position so the spacer inserts between the first and second jaws to urge the first and second jaws to engage the shape memory implant and move the shape memory implant from its first shape to its second shape, with the first and second jaws maintaining the shape memory implant in the second shape.

Loading a plurality of implant insertion devices by cooling to deformation temperature and press activation

A method of loading implant insertion devices with shape memory implants comprising providing a plurality of shape memory implants movable between a first shape and a second shape; providing a plurality of implant insertion devices movable between an implant disengagement position and an implant engagement position; contacting each shape memory implant in its first shape with one of the implant insertion devices in its implant disengagement position; reducing each shape memory implant contacted with one of the implant insertion devices to a temperature at or below a deformation temperature of the shape memory implants; placing a shape memory implant contacted with an implant insertion device in a press tool; activating the press tool to press the implant insertion device and the shape memory implant to move the implant insertion device from its implant disengagement position to its implant engagement position, where the implant insertion device moves the shape memory implant from its first shape to its second shape and maintains the shape memory implant in the second shape; removing the implant insertion device loaded with the shape memory implant in its second shape from the press tool; and repeating steps v.-vii until each implant insertion device is loaded with one of the shape memory implants in its second shape.

Across the independent claims, the insertion device uses a spacer that inserts between two movable jaws in a locked position to urge jaw engagement that both moves a shape memory implant from a first shape to a second shape and maintains it in the second shape, and the disclosed methods include releasing the implant by moving the spacer back to an unlocked position and removing the device so the implant returns to its first shape to secure tissues, with loading concepts that reduce temperature to at or below a deformation temperature and, in some variants, use a press tool to actuate the transition.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Packaging loaded with the shape memory implant in its second shape.

Delivery of a shape memory implant into tissue or bone.

Securing a first bone, bone fragment, or tissue with a second bone, bone fragment, or tissue using the shape memory implant.

Loading an implant insertion device with a shape memory implant, including cooling to at or below a deformation temperature prior to moving the spacer to its locked position.

Loading a plurality of implant insertion devices with shape memory implants, including cooling to at or below a deformation temperature and press-tool activation.

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