System for loading and implanting shape memory implants - Patents.com
The orthopedic fixation system addresses the challenges of existing shape memory implant devices by providing a method for efficient preloading, precise delivery, and controlled tension release, thereby enhancing surgical efficiency and reducing costs.
Patent Information
- Application Number
- JP2022546045
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-01-29
- Filing Date
- 2021-01-29
- Publication Date
- 2025-03-25
- Estimated Expiration
- 2041-01-29
AI Technical Summary
Existing shape memory implant devices for orthopedic immobilization are cumbersome, require laborious loading during surgery, and can damage implants due to mechanical stress, while also being expensive and requiring frequent sterilization.
An orthopedic fixation system comprising an implant and an implant insertion device that constrains the implant to its insertion shape, allows preloading and sterilization, controls tension release, simplifies implant removal, and eliminates the need for tamping by releasing the implant at the bone surface.
The system enables efficient and precise delivery of shape memory implants, reducing surgical complexity and costs, while ensuring proper implant placement and minimizing damage to the implants.
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Abstract
Description
[Technical field]
[0001] The present invention relates broadly to shape memory implants and their implantation using an implantation device, and more specifically, but without limitation, to an orthopedic fixation system including a shape memory implant and an implantation device designed to be loaded with the shape memory implant and then deliver the shape memory implant using the implantation device. [Background technology]
[0002] Shape memory implants are widely used in surgical procedures requiring reattachment or fusion of tissue or bone. Shape memory implants can be constructed from shape memory materials such as Nitinol such that they have a first final shape and the ability to transition to a second shape. Shape memory implants can be either thermally activated (in which case an external heating source or body heat is required to activate the implant) or mechanically activated (in which case a restraining device is required). Shape memory implants that require mechanical restraints store mechanical energy by elastic recovery and then release the stored mechanical energy when the restraining device is released. In these types of implants, the implants are mechanically transitioned to and maintained in their second shape by instrumentation, such that when released from the instrumentation, the implants elastically recover from their second shape to their first final shape.
[0003] In a surgical procedure, the elastic properties of the constrained shape memory implant are utilized as follows: the bones requiring fixation are aligned and the shape memory implant, mechanically deformed to its second shape, is inserted across the bones while maintained within the instrumentation. Once inserted, the shape memory implant maintains the bones fixed together by elastically attempting to return to its first final shape when it is released from the instrumentation. Because the shape memory implant stores mechanical energy, it exerts a continuous force on the bones to which it is fixed as it transitions from the second shape to the first final shape, thereby aiding in the healing process.
[0004] Various types of instrumentation can be used to either maintain the shape memory implant in its second shape or to transition the implant from a first final shape to a temporary second shape. Some companies use metal forceps to open and insert the shape memory implant. These forceps must be sterilized in the hospital, after which the shape memory implant can be placed on the forceps, opened in the desired position, and used for insertion and implantation. Forceps can be effective, but require the implant to be loaded into the forceps during surgery, which can be laborious and time consuming. Additionally, forceps can be large and can interfere with the implantation of the shape memory implant into the patient during surgery. Physicians using forceps can also damage the shape memory implant in various ways, such as stretching the implant beyond the second shape, tiring the implant, or causing metal-on-metal rubbing between the implant and the instrument. Additionally, forceps can be an expensive instrument that requires cleaning and sterilization after each surgery.
[0005] Other instrumentation includes plastic disposable tools for maintaining the shape memory implant in the second shape. This type of instrumentation may be preloaded and sterilized with the implant already in the second shape, and the implant may be preactivated, so that heating by an external heater or body heat is not required after initiation of use. One type of plastic disposable instrument works by fitting the implant inside a passage of substantially the same diameter as the shape memory implant. Using this method, the instrumentation allows the shape memory implant to be preloaded prior to surgery. However, using instrumentation that substantially matches the shape of the shape memory implant can create several problems for the surgeon. First, this type of instrumentation often makes it difficult to remove the shape memory staples after implantation. Specifically, frictional engagement between the shape memory implant attempting to be compressed and the passage of the instrumentation can cause the shape memory implant to stick to the instrumentation, making the surgical procedure more difficult and resulting in insufficient fixation of the tissue or bone. Second, this type of instrumentation provides an unexpected and sudden release of stored mechanical energy when the implant is removed from the device. Thus, this type of instrumentation does not provide any method for slowly transferring the energy stored within the implant from the instrumentation to the bone it is intended to anchor in. Finally, this type of instrumentation can result in entanglement during release, where the implant begins to compress upon release, thereby making extraction of this type of instrumentation more difficult.
[0006] Another type of plastic disposable instrument includes arms that are movable between disengaged and engaged positions. The arms terminate in the jaws so that when the arms are in their engaged positions, the jaws contact the shape memory implant and keep it open for insertion. The movable arms and jaws release the implant without entanglement and also allow for slow migration of the implant, but the jaws, due to their position when they contact the shape memory implant and the path of movement during removal from the shape memory implant, leave the implant sitting on top of the bone surface, which requires tamping the implant to a position flush with the bone surface. As a result, after the implant is removed from the instrument, it may not always be possible to tamp the implant and thereby seat it flush with the bone surface, especially if the implant includes an anchoring member of limited length, making the instrument impractical in certain procedures. Summary of the Invention [Problem to be solved by the invention]
[0007] Therefore, an instrument that constrains a shape memory implant in its second shape, allows the shape memory implant to be preloaded and sterilized prior to surgery, controls the rate of tension release, simplifies removal of the shape memory implant after implantation, and eliminates the need for tamping by releasing the shape memory implant at the bone surface would be beneficial. [Means for solving the problem]
[0008] In accordance with the present invention, an orthopedic fixation system includes an implant and an implant insertion device. The implant transitions between a natural shape and an insertion shape. The implant insertion device moves between a loaded position that constrains the implant in its insertion shape and an unloaded position that releases the implant so that the implant attempts to transition from its insertion shape to its natural shape. More specifically, when the implant is loaded, the implant insertion device jumps over a bridge of the implant and engages a segment of a first anchoring member of the implant at an engagement point and engages a segment of a second anchoring member of the implant at an engagement point, thereby constraining the implant in its insertion shape.
[0009] The implant insertion device includes a body having a first end and a second end, and an implant grip coupled to the body. The implant grip moves relative to the body between an engaged position and a disengaged position. In the engaged position, the implant grip jumps over a bridge and engages a segment of the first anchoring member at its engagement point and engages a segment of the second anchoring member at its engagement point, thereby constraining the implant in its insertion configuration. In the disengaged position, the implant grip releases the implant.
[0010] The implant of the present invention includes a bridge having a first side and a second side and a first end and a second end, and an anchoring member extending from the bridge according to the following configuration: The implant in a first configuration includes a first anchoring member extending from the bridge at a first end of the bridge and a second anchoring member extending from the bridge at a second end of the bridge. The first anchoring member has a side-to-side width such that the first segment extends on its first side to the exterior of the bridge to provide a first engagement point and the second segment extends on its second side to the exterior of the bridge to provide a second engagement point. The second anchoring member has a side-to-side width such that the first segment extends on its first side to the exterior of the bridge to provide a first engagement point and the second segment extends on its second side to the exterior of the bridge to provide a second engagement point.
[0011] The implant in the second configuration includes a first anchoring member extending from the bridge at a first end of the bridge adjacent a first side of the bridge, a second anchoring member extending from the bridge at a second end of the bridge, and a third anchoring member extending from the bridge at the first end of the bridge adjacent a second side of the bridge. The first anchoring member has a side-to-side width such that a segment of the first anchoring member extends to an exterior of the bridge at its first side to provide an engagement point. The second anchoring member has a side-to-side width such that the first segment extends to an exterior of the bridge at its first side to provide a first engagement point and the second segment extends to an exterior of the bridge at its second side to provide a second engagement point. The third anchoring member has a side-to-side width such that a segment of the third anchoring member extends to an exterior of the bridge at its second side to provide an engagement point.
[0012] The implant in a third configuration includes a first anchoring member extending from the bridge at a first end of the bridge adjacent a first side of the bridge, a second anchoring member extending from the bridge at a second end of the bridge adjacent the first side of the bridge, a third anchoring member extending from the bridge at the first end of the bridge adjacent the second side of the bridge, and a fourth anchoring member extending from the bridge at the second end of the bridge adjacent the second side of the bridge. The first anchoring member has a side-to-side width such that a segment of the first anchoring member extends to an exterior of the bridge at its first side to provide an engagement point. The second anchoring member has a side-to-side width such that a segment of the second anchoring member extends to an exterior of the bridge at its first side to provide an engagement point. The third anchoring member has a side-to-side width such that a segment of the third anchoring member extends to an exterior of the bridge at its second side to provide an engagement point. The fourth anchoring member has a side-to-side width such that a segment of the fourth anchoring member extends outside of the bridge on its second side to provide an engagement point.
[0013] An implant insertion device for use with an implant having a first and second anchoring member includes a body having a first end and a second end, and an implant grip coupled to the body at its second end. The implant grip moves relative to the body between an engaged position and a disengaged position. In its engaged position, the implant grip restrains the implant in its insertion configuration by leaping over a bridge and engaging a first segment and a second segment of the first anchoring member at their first and second engagement points and engaging a first segment and a second segment of the second anchoring member at their first and second engagement points. In its disengaged position, the implant grip releases the implant.
[0014] The implant grip includes a shell coupled to the body. The shell includes an outer surface having an upper surface and a lower surface. The shell further includes an inner surface complementary in shape to the implant, such that the inner surface defines a passageway through the shell complementary in shape to the implant. The shell couples the shell to the body at its upper surface by receiving the body at its second end in the passageway. The shell receives the implant in the passageway at its lower surface. Upon receiving the implant, the shell leaps over the bridge at its inner surface and engages the first and second segments of the first anchoring member at their first and second engagement points and engages the first and second segments of the second anchoring member at their first and second engagement points, thereby retaining the implant within the shell and constraining the implant in its insertion configuration.
[0015] The inner surface of the shell defines first, second, third, and fourth grooves. Each of the first, second, third, and fourth grooves receives therein one of the first and second segments of the first and second anchoring members as the shell leaps over the bridge at its inner surface. Additionally, the inner surface engages the first and second anchoring members at the first, second, third, and fourth grooves, thereby retaining the implant within the shell in its inserted configuration. The inner surface further defines a retention surface at each of the first, second, third, and fourth grooves. When the first, second, third, and fourth grooves receive one of the first and second segments of the first and second anchoring members therein, each of the retention surfaces abuts one of the first and second engagement points of the first and second segments of the first and second anchoring members such that the retention surfaces grip and restrain the first and second anchoring members such that the shell retains the implant therein in its insertion configuration.
[0016] The body of the implant insertion device includes an implant grip receiver at its second end that terminates in a tamp. The implant grip receiver is complementary in shape to the inner surface of the shell, and the implant grip receiver is inserted into the passage of the shell at the upper surface of the shell, thereby coupling the implant grip receiver to the shell. When the implant grip is in its engaged position, the tamp rests on the bridge of the implant. Furthermore, the tamp remaining on the bridge of the implant prevents movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
[0017] The implant grip receiver includes a first notch and a second notch, and the inner surface of the shell includes a detent engageable with the first and second notches. When the implant grip moves to its engaged position, the detent engages the first notch to lock the implant grip in its engaged position. Alternatively, when the implant grip moves to its disengaged position, the detent engages the second notch to lock the implant grip in its disengaged position.
[0018] The implant grip in an alternative embodiment of the implant insertion device includes an actuator coupled to the body and movable relative to the body, where movement of the actuator advances the implant grip between its engaged and disengaged positions. The implant grip further includes first and second blades fixable to the actuator in opposing relationship and defining a passage therebetween. The passage receives a bridge of the implant therein, whereby the first and second blades extend beyond the bridge and engage with the first and second segments of the first and second anchoring members at their first and second engagement points to retain and constrain the implant in its insertion configuration. The actuator includes a first slider, a second slider, and a spacer. The first slider is fixed to the first blade and the second slider is fixed to the second blade. A spacer is secured between the first slider and the second slider such that the first blade and the second blade are spaced apart to define a passage therebetween.
[0019] The body in an alternative embodiment of the implant insertion device defines a tamp at a second end thereof. The body further defines a slot communicating with the exterior of the body for receiving the spacer therein. The first slider is secured to the spacer adjacent a first surface of the body, and the second slider is secured to the spacer adjacent a second surface of the body. The first blade and the second blade extend beyond the tamp such that a passage between the first blade and the second blade is located adjacent the tamp. When the implant grip is in its engaged position, the tamp is located above the bridge of the implant. Furthermore, the tamp remains above the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
[0020] An implant insertion device for use with an implant having a first anchoring member, a second anchoring member, and a third anchoring member includes a body having a first end and a second end, and an implant grip coupled to the body at its second end. The implant grip moves relative to the body between an engaged position and a disengaged position. In its engaged position, the implant grip restrains the implant in its insertion configuration by leaping over a bridge and engaging segments of the first and third anchoring members at their engagement points and engaging first and second segments of the second anchoring member at their first and second engagement points. In its disengaged position, the implant grip releases the implant.
[0021] The implant grip includes a shell coupled to the body. The shell includes an outer surface having an upper surface and a lower surface. The shell further includes an inner surface complementary in shape to the implant such that the inner surface defines a passageway through the shell complementary in shape to the implant. The shell couples the shell to the body at its upper surface by receiving the body at its second end in the passageway. The shell receives the implant in the passageway at its lower surface. Upon receiving the implant, the shell leaps over the bridge at its inner surface and engages segments of the first and third anchoring members at their engagement points and engages first and second segments of the second anchoring member at their first and second engagement points, thereby retaining the implant within the shell and constraining the implant in its insertion configuration.
[0022] The inner surface of the shell defines a first, second, third, and fourth groove. Each of the first, second, third, and fourth grooves receives one of the segments of the first and third anchoring members and the first and second segments of the second anchoring member therein as the shell leaps over the bridge at its inner surface. Additionally, the inner surface engages the first, second, third, and third anchoring members at the first, second, third, and fourth grooves, thereby retaining the implant in its insertion configuration within the shell. The inner surface further defines a retention surface at each of the first, second, third, and fourth grooves. When the first, second, third, and fourth grooves receive one of the segments of the first and third anchoring members and the first and second segments of the second anchoring member therein, each of the retention surfaces abuts one of the engagement points of the segments of the first and third anchoring members and the first and second engagement points of the first and second segments of the second anchoring member, such that the retention surfaces grip and restrain the first, second, and third anchoring members, thereby causing the shell to retain the implant therein in its insertion configuration.
[0023] The inner surface of the shell includes protrusions, which may be resilient. When the shell jumps over the bridge on its inner surface, the protrusions also jump over the bridge and engage one of the first and third anchoring members, thereby holding the implant therein in its insertion shape. If the protrusions are resilient, they jump over the bridge by moving relative to the bridge and engage one of the first and third anchoring members, thereby holding the implant therein in its insertion shape.
[0024] The body of the implant insertion device includes an implant grip receiver at its second end that terminates in a tamp. The implant grip receiver is complementary in shape to the inner surface of the shell such that the implant grip receiver is inserted into the passage of the shell at the top surface of the shell, thereby coupling the implant grip receiver with the shell. When the implant grip is in its engaged position, the tamp rests on the bridge of the implant. Furthermore, the tamp remaining on the bridge of the implant prevents movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
[0025] The implant grip receiver includes a first notch and a second notch, and the inner surface of the shell includes a detent engageable with the first and second notches. When the implant grip moves to its engaged position, the detent engages the first notch to lock the implant grip in its engaged position. Alternatively, when the implant grip moves to its disengaged position, the detent engages the second notch to lock the implant grip in its disengaged position.
[0026] The implant grip in an alternative embodiment of the implant insertion device includes an actuator coupled to the body and movable relative to the body, movement of the actuator advancing the implant grip between its engaged and disengaged positions. The implant grip further includes first and second blades fixable to the actuator in opposing relationship and defining a passage therebetween. The passage receives a bridge of the implant therein, and the first and second blades extend beyond the bridge to engage with segments of the first and third anchoring members at their engagement points and with the first and second segments of the second anchoring member at their first and second engagement points to retain and constrain the implant in its insertion configuration. The actuator includes a first slider, a second slider, and a spacer. The first slider is fixed to the first blade, and the second slider is fixed to the second blade. A spacer is secured between the first slider and the second slider such that the first blade and the second blade are spaced apart to define a passage therebetween.
[0027] The body in an alternative embodiment of the implant insertion device defines a tamp at a second end thereof. The body further defines a slot communicating with the exterior of the body for receiving the spacer therein. The first slider is secured to the spacer adjacent a first surface of the body, and the second slider is secured to the spacer adjacent a second surface of the body. The first blade and the second blade extend beyond the tamp such that a passage between the first blade and the second blade is located adjacent the tamp. When the implant grip is in its engaged position, the tamp is located above the bridge of the implant. Furthermore, the tamp remains above the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
[0028] An implant insertion device for use with an implant having a first anchoring member, a second anchoring member, a third anchoring member, and a fourth anchoring member includes a body having a first end and a second end, and an implant grip coupled to the body at the second end. The implant grip moves relative to the body between an engaged position and a disengaged position. In the engaged position, the implant grip jumps over a bridge and engages segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at their engagement points, whereby the implant grip restrains the implant in its insertion configuration. In the disengaged position, the implant grip releases the implant.
[0029] The implant grip includes a shell coupled to the body. The shell includes an outer surface having an upper surface and a lower surface. The shell further includes an inner surface complementary in shape to the implant such that the inner surface defines a passageway through the shell complementary in shape to the implant. The shell couples the shell to the body at its upper surface by receiving the body at its second end in the passageway. The shell receives the implant in the passageway at its lower surface. Upon receiving the implant, the shell at its inner surface leaps over the bridge and engages segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member at their engagement points, thereby retaining the implant within the shell and restraining the implant in its insertion configuration.
[0030] The inner surface of the shell defines a first, second, third, and fourth groove. When the shell leaps over the bridge at its inner surface, each of the first, second, third, and fourth grooves receives therein one of the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member. Additionally, the inner surface engages the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at the first, second, third, and fourth grooves, thereby retaining the implant in its insertion configuration within the shell. The inner surface further defines a retention surface at each of the first, second, third, and fourth grooves. When the first, second, third, and fourth grooves receive one of the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member therein, each of the retention surfaces abuts one of the engagement points of the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member, and in response, the retention surfaces grip and restrain the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member, thereby causing the shell to retain the implant therein in its insertion configuration.
[0031] The inner surface of the shell includes protrusions, which may be elastic. When the shell jumps over the bridge on its inner surface, the protrusions also jump over the bridge and engage one of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member, thereby holding the implant therein in its insertion shape. If the protrusions are elastic, they jump over the bridge by moving relative to it and engage one of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member, thereby holding the implant therein in its insertion shape.
[0032] The body of the implant insertion device includes an implant grip receiver at its second end that terminates in a tamp. The implant grip receiver is complementary in shape to the inner surface of the shell such that the implant grip receiver is inserted into the passage of the shell at the top surface of the shell, thereby coupling the implant grip receiver with the shell. When the implant grip is in its engaged position, the tamp rests on the bridge of the implant. Furthermore, the tamp remaining on the bridge of the implant prevents movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
[0033] The implant grip receiver includes a first notch and a second notch, and the inner surface of the shell includes a detent engageable with the first and second notches. When the implant grip moves to its engaged position, the detent engages the first notch to lock the implant grip in its engaged position. Alternatively, when the implant grip moves to its disengaged position, the detent engages the second notch to lock the implant grip in its disengaged position.
[0034] The implant grip in an alternative embodiment of the implant insertion device includes an actuator coupled to the body and movable relative to the body, where movement of the actuator advances the implant grip between its engaged and disengaged positions. The implant grip further includes a first blade and a second blade fixable to the actuator in opposing relationship and defining a passage therebetween. The passage receives a bridge of the implant therein, whereby the first and second blades extend beyond the bridge and engage segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at their engagement points, thereby retaining the implant and restraining the implant in its insertion configuration. The actuator includes a first slider, a second slider, and a spacer. The first slider is fixed to the first blade, and the second slider is fixed to the second blade. A spacer is secured between the first slider and the second slider such that the first blade and the second blade are spaced apart to define a passage therebetween.
[0035] The body in an alternative embodiment of the implant insertion device defines a tamp at a second end thereof. The body further defines a slot communicating with the exterior of the body for receiving the spacer therein. The first slider is secured to the spacer adjacent a first surface of the body, and the second slider is secured to the spacer adjacent a second surface of the body. The first blade and the second blade extend beyond the tamp such that a passage between the first blade and the second blade is located adjacent the tamp. When the implant grip is in its engaged position, the tamp is located above the bridge of the implant. Furthermore, the tamp remains above the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
[0036] The implants of the present invention with anchoring members extending from the bridge can be implanted through the use of drill holes formed in the bone, bones, or bone fragments. Furthermore, it is often preferable to introduce the implant into the bone, bones, or bone fragments near a fixation device that holds the bone, bones, or bone fragments in a desired alignment. To allow for such implantation, the drill guide in various embodiments is configured to drill holes in the bone, bones, or bone fragments near the fixation device.
[0037] The drill guide in one embodiment includes first and second passages therethrough, and in an alternative embodiment, third and fourth passages therethrough. The drill guide includes a grip extending from a body and a template depending from the body between the first and second passages. The template includes a slot, the first passage located adjacent a first side of the slot and exterior to the slot, and the second passage located adjacent a second side of the slot and exterior to the slot. Additionally, the distance between the first and second passages is substantially equal to the distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant is in an insertion configuration, plus a distance equal to the thickness of the template.
[0038] Positioning the body over the bone, bones, or bone fragments using the grip introduces the template into the fusion zone of the bone, bones, or bone fragments such that the slot receives therein a fixation device inserted into the bone, bones, or bone fragments. With the template in the fusion zone and the fixation device in the slot, the first passage is located on the bone, bones, or bone fragments near the first side of the fixation device and adjacent to a first side of the fusion zone, and the second passage is located on the bone, bones, or bone fragments near the second side of the fixation device and adjacent to a second side of the fusion zone. Drilling a drill hole into the bone, bones, or bone fragments using the first and second passages results in the drill hole being positioned near the fixation device due to the positioning of the first and second passages on the bone, bones, or bone fragments.
[0039] When the drill guide incorporates a third passage, the body includes a first passage disposed at a first end of the body adjacent a first side of the body, a second passage disposed at the first end of the body adjacent a second side of the body, and a third passage disposed at the second end of the body adjacent one of the first side of the body and the second side of the body. The drill guide includes a grip extending from the body and a template depending from the body between the first, second and third passages. The template includes a slot whereby the first passage is located outside the slot adjacent its first side, the second passage is located outside the slot adjacent its second side, and the third passage is located outside the slot adjacent one of the first and second sides. In addition, the distance between the first and second passages and the third passage is substantially equal to the distance between the first and second anchoring members at the first end of the implant and the third anchoring member at the second end of the implant when the implant is in the insertion configuration, plus a distance equal to the thickness of the template.
[0040] The template is introduced into the fusion zone of the bone, bones, or bone fragments by using the grip to place the body over the bone, bones, or bone fragments such that the slot receives therein a fixation device inserted into the bone, bones, or bone fragments. With the template in the fusion zone and the fixation device in the slot, the first passage is located on the bone, bones, or bone fragments adjacent to a first side of the fusion zone near a first side of the fixation device, the second passage is located on the bone, bones, or bone fragments adjacent to a first side of the fusion zone near a second side of the fixation device, and the third passage is located on the bone, bones, or bone fragments adjacent to a second side of the fusion zone near one of the first side of the fixation device and the second side of the fixation device. When the first, second, and third passages are used to drill holes in the bone, bones, or bone fragments, the drill holes are located near the fixation device due to the location of the first, second, and third passages on the bone, bones, or bone fragments.
[0041] When the drill guide incorporates third and fourth passages, the body includes a first passage disposed at a first end of the body adjacent a first side of the body, a second passage disposed at the first end of the body adjacent a second side of the body, a third passage disposed at the second end of the body adjacent the first side of the body, and a fourth passage disposed at the second end of the body adjacent the second side of the body. The drill guide includes a grip extending from the body and a template depending from the body between the first and second passages and the third and fourth passages. The template includes a slot, the first and third passages being located outside the slot adjacent a first side thereof and the second and fourth passages being located outside the slot adjacent a second side thereof. In addition, the distance between the first and third passages and the second and fourth passages is substantially equal to the distance between the first and second anchoring members at a first end of the implant and the third and fourth anchoring members at a second end of the implant when the implant is in the insertion configuration, plus a distance equal to the thickness of the template.
[0042] The template is introduced into the fusion zone of the bone, bones, or bone fragments by using the grip to place the body over the bone, bones, or bone fragments such that the slot receives therein a fixation device inserted into the bone, bones, or bone fragments. With the template in the fusion zone and the fixation device in the slot, the first passage is located on the bone adjacent to a first side of the fusion zone near a first side of the fixation device, the second passage is located on the bone adjacent to a first side of the fusion zone near a second side of the fixation device, the third passage is located on the bone adjacent to a second side of the fusion zone near a first side of the fixation device, and the fourth passage is located on the bone adjacent to a second side of the fusion zone near a second side of the fixation device. When the first, second, third, and fourth passages are used to drill holes in the bone, bones, or bone fragments, the drill holes are located near the fixation device due to the location of the first, second, third, and fourth passages on the bone, bones, or bone fragments.
[0043] The drill guide in another embodiment includes first and second passages therethrough, and in the alternative embodiment, third and fourth passages therethrough. The drill guide includes a first grip extending from the body adjacent the first passage and a first template depending from the first grip. The drill guide includes a second grip extending from the body adjacent the second passage and a second template depending from the second grip. The first and second templates each include a slot having a first side and a second side, whereby the first passage is located outside the slots of the first and second templates at its first side, and the second passage is located outside the slots of the first and second templates at its second side. Additionally, the distance between the first and second passages is substantially equal to the distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant is in the insertion configuration.
[0044] Using at least one of the first grip and the second grip, the body is positioned over the bone, bones, or bone fragments across its fusion zone, such that the first template is introduced adjacent a first portion of the bone, bones, or bone fragments and the second template is introduced adjacent a second portion of the bone, bones, or bone fragments, such that the slots of the first and second templates receive therein a fixation device inserted through the bone, bones, or bone fragments. With the first and second templates adjacent the bone, bones, or bone fragments and the fixation device within the respective slots, the first passageway is located on the bone, bones, or bone fragments adjacent a first side of the fusion zone near a first side of the fixation device and the second passageway is located on the bone, bones, or bone fragments adjacent a second side of the fusion zone near a second side of the fixation device. When a drill hole is drilled into the bone, bones, or bone fragment using the first and second passageways, the drill hole is positioned near the fixation device due to the positioning of the first and second passageways on the bone, bones, or bone fragment.
[0045] When the drill guide incorporates a third passage, the body includes a first passage disposed at a first end of the body adjacent a first side of the body, a second passage disposed at the first end of the body adjacent a second side of the body, and a third passage disposed at the second end of the body adjacent one of the first side of the body and the second side of the body. The drill guide includes a first grip extending from the body adjacent the first and second passages and a first template depending from the first grip. The drill guide includes a second grip extending from the body adjacent the third passage and a second template depending from the second grip. The first and second templates each include a slot having a first side and a second side, whereby the first passageway is located outside the slots of the first and second templates at its first side, the second passageway is located outside the slots of the first and second templates at its second side, and the third passageway is located outside the slots of the first and second templates at one of its first and second sides. In addition, a distance between the first and second passageway and the third passageway is substantially equal to a distance between the first and second anchoring members at the first end of the implant and the third anchoring member at the second end of the implant when the implant is in the insertion configuration.
[0046] Using at least one of the first grip and the second grip, the body is positioned on the bone, bones, or bone fragments across its fusion zone, such that the first template is introduced adjacent a first portion of the bone, bones, or bone fragments and the second template is introduced adjacent a second portion of the bone, bones, or bone fragments such that the slots of the first and second templates receive therein a fixation device inserted through the bone. With the first and second templates adjacent the bone, bones, or bone fragments and the fixation device within the respective slots, the first passageway is located on the bone, bones, or bone fragments adjacent a first side of the fusion zone near the first side of the fixation device, the second passageway is located on the bone, bones, or bone fragments adjacent the first side of the fusion zone near the second side of the fixation device, and the third passageway is located on the bone, bones, or bone fragments adjacent a second side of the fusion zone near one of the first side of the fixation device and the second side of the fixation device. When drilling holes in the bone, bones, or bone fragments using the first, second, and third passages, the drill holes are positioned near the fixation device due to the positioning of the first, second, and third passages on the bone, bones, or bone fragments.
[0047] When the drill guide incorporates third and fourth passages, the body includes a first passage disposed at a first end of the body adjacent to a first side of the body, a second passage disposed at a first end of the body adjacent to a second side of the body, a third passage disposed at a second end of the body adjacent to the first side of the body, and a fourth passage disposed at a second end of the body adjacent to the second side of the body. The drill guide includes a first grip extending from the body adjacent to the first and second passages, and a first template depending from the first grip. The drill guide includes a second grip extending from the body adjacent to the third and fourth passages. The first and second templates each include a slot having a first side and a second side, whereby the first and third passageways are located outside the slots of the first and second templates on their first side and the second and fourth passageways are located outside the slots of the first and second templates on their second side, and a distance between the first and third passageways and the second and fourth passageways is substantially equal to a distance between the first and second anchoring members at the first end of the implant and the third and fourth anchoring members at the second end of the implant when the implant is in the insertion configuration.
[0048] Using at least one of the first grip and the second grip, the body is positioned on the bone, bones, or bone fragments across the fusion zone thereof, such that the first template is introduced adjacent to a first portion of the bone, bones, or bone fragments and the second template is introduced adjacent to a second portion of the bone, bones, or bone fragments, such that the slots of the first template and the second template receive therein a fixation device inserted through the bone, bones, or bone fragments. With the first and second templates adjacent the bone, bones, or bone fragments and the fixation devices in their respective slots, the first passageway is located on the bone, bones, or bone fragments adjacent a first side of the fixation device, the second passageway is located on the bone, bones, or bone fragments adjacent a first side of the fusion zone, near a second side of the fixation device, the third passageway is located on the bone, bones, or bone fragments adjacent a second side of the fusion zone, near the first side of the fixation device, and the fourth passageway is located on the bone, bones, or bone fragments adjacent a second side of the fusion zone, near the second side of the fixation device. When drilling holes in the bone, bones, or bone fragments using the first, second, third, and fourth passageways, the drill holes are located near the fixation device due to the location of the first, second, third, and fourth passageways on the bone, bones, or bone fragments.
[0049] According to a method of an orthopedic fixation system including an implant having a first anchoring member and a second anchoring member extending from a bridge, an implant insertion device is loaded with an implant. The implant insertion device jumps over the bridge and engages a segment of the first anchoring member at its engagement point and engages a segment of the second anchoring member at its engagement point, whereby the implant insertion device restrains the implant in its insertion configuration. An implant utilizing the implant insertion device is positioned with its first anchoring member in the first bone and its second anchoring member in the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the segments of the first and second anchoring members until the bridge is located adjacent to and spanning the fusion zones of the first and second bones while the implant insertion device is used to insert the first anchoring member into the first bone and the second anchoring member into the second bone. The engagement between the implant insertion device and the segments of the first and second anchoring members is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its insertion shape to its natural shape.
[0050] Loading the implant into the implant insertion device includes moving the implant grip relative to the body, where the implant grip jumps over the bridge and engages a segment of the first anchoring member at its engagement point and engages a segment of the second anchoring member at its engagement point, such that the implant grip constrains the implant in its insertion configuration. Positioning and embedding the implant includes utilizing the body of the implant insertion device to position the implant with the first anchoring member in the first bone and the second anchoring member in the second bone, with the bridge spanning the fusion zone of the first and second bones. The implant grip moves relative to the body, whereby the implant grip retracts from the segments of the first and second anchoring members. Utilizing the body, the first anchoring member is inserted into the first bone and the second anchoring member is inserted into the second bone until the bridge is located adjacent the first and second bones spanning the fusion zones. The implant grip moves relative to the body until the segments of the first and second anchoring members are released by the implant grip, causing the implant grip to jump over the bridge and release the implant, causing the implant to attempt to transition from its insertion shape to its natural shape.
[0051] Positioning and embedding the implant includes positioning the implant utilizing a body of an implant insertion device with its first anchoring member in the first bone and its second anchoring member in the second bone, with the bridge spanning the fusion zones of the first and second bones. The first anchoring member is inserted into the first bone and the second anchoring member is inserted into the second bone utilizing the body until the implant grips contact the first and second bones. More specifically, pushing the body results in the first anchoring member being inserted into the first bone and the second anchoring member being inserted into the second bone, with its second end via the bridge, until the bridge is located adjacent the first and second bones spanning the fusion zones. Further, the implant grip moves relative to the body through contact with the first bone and the second bone until the segments of the first and second anchoring members are released by the implant grip, causing the implant grip to jump over the bridge and release the implant, which then attempts to transition from its insertion shape to its natural shape.
[0052] Loading the implant insertion device according to an alternative embodiment includes positioning the body relative to the implant such that the second end of the body abuts the bridge of the implant. The actuator moves relative to the body such that the first blade and the second blade extend beyond the bridge and engage segments of the first anchor member and the second anchor member, respectively, at their engagement points such that the implant grips restrain the implant in its insertion configuration.
[0053] Positioning and embedding the implant includes utilizing a body of an implant insertion device to position the implant with its first anchoring member in the first bone and its second anchoring member in the second bone, with its bridge spanning the fusion zone of the first and second bones. The actuator moves relative to the body, causing the first blade and the second blade to retract from the segments of the first anchoring member and the second anchoring member, respectively. The first anchoring member is inserted into the first bone and the second anchoring member is inserted into the second bone, using the body, until the bridge is located adjacent the first bone and spanning the fusion zone of the second bone. The actuator moves relative to the body, causing the first blade and the second blade to release the segments of the first anchoring member and the second anchoring member, respectively, causing the first blade and the second blade to jump over the bridge and release the implant, such that the implant attempts to transition from its inserted configuration to its natural configuration.
[0054] When using a drill guide during implantation of the implant, the fixation device is inserted into the first bone and the second bone across their fusion zones. The template is introduced into the fusion zones of the first and second bones using the grips until the slots receive the fixation device therein, the first passage is located on the first bone near the first side of the fixation device and adjacent to the first side of the fusion zone, and the second passage is located on the second bone near the second side of the fixation device and adjacent to the second side of the fusion zone, and the body spans the fusion zones. A first drill hole is formed in the first bone using the first passage and a second drill hole is formed in the second bone using the second passage, and the drill guide is subsequently removed from the first and second bones. The first and second bones are compressed at their fusion zones, thereby shortening their separation distance. The implant insertion device positions the implant with its first anchoring member in the first drill hole of the first bone and its second anchoring member in the second drill hole of the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the segments of the first and second anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone and the second anchoring member into the second drill hole of the second bone until the bridge is located adjacent to the first and second bones spanning their fusion zones. The engagement of the implant insertion device with the segments of the first and second anchoring members is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted shape to its natural shape. If necessary, the fixation device is removed from the first and second bones.The distance between the first and second passages is substantially equal to the distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant is in its insertion configuration plus a distance equal to the thickness of the template, such that removing the template from the fusion zone and compressing the first and second bones at their fusion zones will shorten the separation distance of the first drill hole from the second drill hole to the separation distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant is in its insertion configuration.
[0055] When using the alternative drill guide during implantation, the fixation device is inserted into the first and second bones across the fusion zone. The body of the drill guide is positioned across the fusion zone on the first and second bones using at least one of the first and second grips, whereby the first template is positioned adjacent to the first bone and the second template is positioned adjacent to the second bone, such that the slots of the first and second templates receive the fixation device therein. With the body of the drill guide on the first and second bones, the first passage is positioned on the first bone adjacent to the first side of the fusion zone near the first side of the fixation device and the second passage is positioned on the second bone adjacent to the second side of the fusion zone near the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passageway and a second drill hole is formed in the second bone utilizing the second passageway, followed by removal of the drill guide from the first and second bones. The implant insertion device positions the implant with its first anchoring member in the first drill hole of the first bone and its second anchoring member in the second drill hole of the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the segments of the first and second anchoring members until the bridge is located adjacent the first and second bones spanning their fusion zones while the implant insertion device inserts the first anchoring member in the first drill hole of the first bone and the second anchoring member in the second drill hole of the second bone. The engagement between the implant insertion device and the segments of the first and second anchoring members is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration. Optionally, the fixation devices are removed from the first and second bones.
[0056] According to a method of an orthopedic fixation system including an implant having a first anchoring member, a second anchoring member, and a third anchoring member extending from a bridge, an implant insertion device is loaded with the implant. An implant gripper jumps over the bridge and engages the segments of the first anchoring member and the third anchoring member at their engagement points and engages the first and second segments of the second anchoring member at their first and second engagement points, whereby the implant gripper restrains the implant in its insertion configuration. Utilizing the implant insertion device, the implant is positioned with its first and third anchoring members in the first bone and its second anchoring member in the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the segments of the first and third anchoring members and the first and second segments of the second anchoring member until the bridge is located adjacent to and spanning the fusion zones of the first and second bones while the implant insertion device is being used to insert the first and third anchoring members into the first bone and the second anchoring member into the second bone. Engagement of the implant insertion device with the segments of the first and third anchoring members and the first and second segments of the second anchoring member is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration.
[0057] Loading the implant into the implant insertion device includes moving the implant grip relative to the body, whereby the implant grip jumps over the bridge and engages the segments of the first and third anchoring members at their engagement points and engages the first and second segments of the second anchoring member at their first and second engagement points, whereby the implant grip restrains the implant in its insertion configuration. Positioning and embedding the implant includes utilizing the body of the implant insertion device to position the implant with its first and third anchoring members in the first bone and its second anchoring member in the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant grip moves relative to the body, whereby the implant grip retracts from the segments of the first and third anchoring members and the first and second segments of the second anchoring member. Utilizing the body, the first and third anchoring members are inserted into the first bone and the second anchoring member is inserted into the second bone until the bridge is located adjacent the first and second bones spanning their fusion zones. The implant gripper is moved relative to the body until the segments of the first and third anchoring members and the first and second segments of the second anchoring member are released by the implant gripper, causing the implant gripper to jump over the bridge and release the implant so that it attempts to transition from its insertion configuration to its natural configuration.
[0058] Positioning and embedding the implant includes utilizing a body of the implant insertion device to position the implant with its first and third anchoring members in the first bone and its second anchoring member in the second bone, with the bridge spanning the fusion zones of the first and second bones. Utilizing the body, the first and third anchoring members are inserted into the first bone and the second anchoring member is inserted into the second bone until the implant grips contact the first and second bones. More specifically, pushing the body results in the second end of the body inserting the first and third anchoring members into the first bone and the second anchoring member into the second bone, via the bridge, until the bridge is located adjacent the first and second bones spanning the fusion zones. The implant grip moves relative to the body until contact with the first and second bones causes the segments of the first and third anchoring members and the first and second segments of the second anchoring member to be released by the implant grip, causing the implant grip to jump over the bridge and release the implant, which then attempts to transition from its insertion shape to its natural shape.
[0059] Loading an implant insertion device according to an alternative embodiment includes positioning the body relative to the implant such that the second end of the body abuts the bridge of the implant, and moving the actuator relative to the body such that the first blade and the second blade extend beyond the bridge and engage segments of the first and third anchoring members at their engagement points, respectively, and engage first and second segments of the second anchoring member at their first and second engagement points, whereby the implant grip constrains the implant in its insertion configuration.
[0060] Positioning and embedding the implant includes utilizing a body of the implant insertion device to position the implant with its first and third anchoring members in the first bone and its second anchoring member in the second bone, with its bridge spanning the fusion zones of the first and second bones. The actuator moves relative to the body, whereby the first and second blades retract from the segments of the first and third anchoring members and the first and second segments of the second anchoring member, respectively. Utilizing the body, the first and third anchoring members are inserted into the first bone and the second anchoring member is inserted into the second bone until the bridge is located adjacent the first and second bones spanning the fusion zones. The actuator moves relative to the body until the first blade and the second blade release the segments of the first and third anchoring members and the first and second segments of the second anchoring member, respectively, causing the first blade and the second blade to jump the bridge and release the implant, which then attempts to transition from its insertion shape to its natural shape.
[0061] When using a drill guide during implantation of the implant, the fixation device is inserted into the first and second bones across their fusion zones. The template is introduced into the fusion zones of the first and second bones using the grip until the slot receives the fixation device therein, the first passage is located on the first bone near the first side of the fixation device and adjacent to the first side of the fusion zone, the second passage is located on the first bone near the second side of the fixation device and adjacent to the first side of the fusion zone, and the third passage is located on the second bone near one of the first side of the fixation device and the second side of the fixation device and adjacent to the second side of the fusion zone, and the body spans the fusion zone. A first drill hole is formed in the first bone using the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone using the third passage, and then the drill guide is removed from the first and second bones. The first and second bones are compressed at their fusion zones, thereby reducing their separation distance. The implant insertion device positions the implant with its first anchoring member in the first drill hole of the first bone, its second anchoring member in the second drill hole of the first bone, and its third anchoring member in the drill hole of the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the first anchoring member, second anchoring member, and third anchoring member segments while the implant insertion device inserts the first anchoring member in the first drill hole of the first bone, the second anchoring member in the second drill hole of the first bone, and the third anchoring member in the drill hole of the second bone until the bridge is located adjacent the first and second bones spanning their fusion zones. The engagement between the implant insertion device and the segments of the first anchor member, the second anchor member, and the third anchor member is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration. Optionally, the fixation devices are removed from the first bone and the second bone.The distance between the first and second passages and the third passage is substantially equal to the distance between the first and second anchoring members of the implant and the third anchoring member of the implant when the implant is in its insertion configuration plus a distance equal to the thickness of the template, such that removing the template from the fusion zone and compressing the first and second bones at their fusion zones will shorten the separation distance of the first and second drill holes of the first bone from the drill holes of the second bone to the separation distance between the first and second anchoring members of the implant and the third anchoring member of the implant when the implant is in its insertion configuration.
[0062] When using an alternative drill guide during implantation, a fixation device is inserted into the first and second bones across their fusion zones. The body of the drill guide on the first and second bones is positioned across their fusion zones using at least one of the first and second grips, whereby the first template is positioned adjacent to the first bone and the second template is positioned adjacent to the second bone, such that the slots of the first and second templates receive the fixation device therein. With the body of the template on the first and second bones, the first passage is positioned on the first bone adjacent to the first side of the fusion zone near the first side of the fixation device, the second passage is positioned on the first bone adjacent to the first side of the fusion zone near the second side of the fixation device, and the third passage is positioned on the second bone adjacent to the second side of the fusion zone near one of the first side of the fixation device and the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passageway, a second drill hole is formed in the first bone using the second passageway, and a drill hole is formed in the second bone using the third passageway, followed by removal of the drill guide from the first bone and the second bone. The implant insertion device positions the implant with its first anchoring member in the first drill hole in the first bone, its second anchoring member in the second drill hole in the first bone, and its third anchoring member in the drill hole in the second bone, with the bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the first, second and third anchoring member segments while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone and the third anchoring member into the drill hole of the second bone until the bridge is located adjacent the first and second bones spanning their fusion zones, and engagement between the implant insertion device and the first, second and third anchoring member segments is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration.Optionally, the fixation devices are removed from the first bone and the second bone.
[0063] According to a method of an orthopedic fixation system including an implant having a first anchor member, a second anchor member, a third anchor member, and a fourth anchor member extending from a bridge, an implant insertion device is loaded with the implant. The implant insertion device jumps over the bridge and engages the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member at their engagement points, whereby the implant grips restrain the implant in its insertion configuration. Utilizing the implant insertion device, the implant is positioned with its first and second anchor members on the first bone and its third and fourth anchor members on the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the first, second, third and fourth anchoring member segments until the bridge is located adjacent to and spanning the fusion zones of the first and second bones while the implant insertion device is being used to insert the first and second anchoring members into the first bone and the third and fourth anchoring members into the second bone, and engagement between the implant insertion device and the first, second, third and fourth anchoring member segments is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration.
[0064] Loading the implant into the implant insertion device includes moving the implant grip relative to the body, where the implant grip jumps over the bridge and engages the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member at the engagement point, such that the implant grip restrains the implant in its insertion configuration. Positioning and embedding the implant includes utilizing the body of the implant insertion device to position the implant with its first anchor member and second anchor member in the first bone and its third anchor member and fourth anchor member in the second bone, with its bridge spanning the fusion zone of the first bone and the second bone. The implant grip moves relative to the body, whereby the implant grip retracts from the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member. Utilizing the body, the first and second anchoring members are inserted into the first bone and the third and fourth anchoring members are inserted into the second bone until the bridge is located adjacent the first and second bones spanning their fusion zones. The implant gripper is moved relative to the body until the first, second, third and fourth anchoring member segments are released by the implant gripper, causing the implant gripper to jump over the bridge and release the implant, which then attempts to transition from its insertion configuration to its natural configuration.
[0065] Positioning and embedding the implant includes utilizing a body of the implant insertion device to position the implant with its first and second anchoring members in the first bone and its third and fourth anchoring members in the second bone, with the bridge spanning the fusion zones of the first and second bones. Utilizing the body, the first and second anchoring members are inserted into the first bone and the third and fourth anchoring members are inserted into the second bone until the implant grips contact the first and second bones. More specifically, pushing the body results in the second end of the body inserting the first and second anchoring members into the first bone and the third and fourth anchoring members into the second bone through the bridge until the bridge is located adjacent the first and second bones spanning the fusion zones. The implant grip moves relative to the body through contact with the first bone and the second bone until segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member are released by the implant grip, causing the implant grip to jump over the bridge and release the implant, which then attempts to transition from its insertion shape to its natural shape.
[0066] Loading an implant insertion device according to an alternative embodiment includes positioning the body relative to the implant such that the second end of the body abuts the bridge of the implant. The actuator moves relative to the body such that the first blade and the second blade extend beyond the bridge and engage segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member, respectively, at their engagement points such that the implant grips restrain the implant in its insertion configuration.
[0067] Positioning and embedding the implant includes utilizing a body of the implant insertion device to position the implant with its first and second anchoring members in the first bone and its third and fourth anchoring members in the second bone, with the bridge spanning the fusion zone of the first and second bones. The actuator moves relative to the body, whereby the first and second blades retract from the segments of the first, second, third and fourth anchoring members, respectively. Utilizing the body, the first and second anchoring members are inserted into the first bone and the third and fourth anchoring members are inserted into the second bone until the bridge is located adjacent the first and second bones spanning the fusion zones. The actuator moves relative to the body until the first blade and the second blade release segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member, respectively, causing the first blade and the second blade to jump the bridge and release the implant, which then attempts to transition from its insertion configuration to its natural configuration.
[0068] When using a drill guide during implantation of an implant, a fixation device is inserted into the first and second bones across their fusion zones. The template is introduced into the fusion zones of the first and second bones utilizing the grips until the slot receives the fixation device therein, the first passage is located on the first bone adjacent the first side of the fusion zone near the first side of the fixation device, the second passage is located on the first bone adjacent the first side of the fusion zone near the second side of the fixation device, the third passage is located on the second bone adjacent the second side of the fusion zone near the first side of the fixation device, and the fourth passage is located on the second bone adjacent the second side of the fusion zone near the second side of the fixation device, and the body spans the fusion zones. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, a first drill hole is formed in the second bone using the third passage, and a second drill hole is formed in the second bone using the fourth passage, followed by removing the drill guide from the first bone and the second bone. The first bone and the second bone are compressed at their fusion zones, thereby reducing their separation distance. The implant insertion device positions the implant with its first anchoring member in the first drill hole of the first bone, its second anchoring member in the second drill hole of the first bone, its third anchoring member in the first drill hole of the second bone, and its fourth anchoring member in the second drill hole of the second bone, with its bridge spanning the fusion zones of the first and second bones. The implant insertion device retracts from the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member segments while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone, the third anchoring member into the first drill hole of the second bone, and the fourth anchoring member into the second drill hole of the second bone until the bridge is located adjacent the first bone and across their fusion zones.The engagement between the implant insertion device and the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration. Optionally, the fixation devices are removed from the first bone and the second bone. The distance between the first and third passages and the second and fourth passages is substantially equal to the distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant is in its insertion configuration plus a distance equal to the thickness of the template, such that removing the template from the fusion zone and compressing the first and second bones at their fusion zones will shorten the separation distance of the first drill hole of the first bone from the first drill hole of the second bone, and the separation distance of the second drill hole of the first bone from the second drill hole of the second bone to the separation distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant is in its insertion configuration.
[0069] When using the alternative drill guide during implantation, a fixation device is inserted into the first and second bones across their fusion zones, and the body of the drill guide is positioned across the first and second bones across their fusion zones using at least one of the first and second grips, such that the first template is positioned adjacent the first bone and the second template is positioned adjacent the second bone, such that the slots of the first and second templates receive the fixation device therein. With the body of the drill guide on the first bone and the second bone, a first passageway is located on the first bone adjacent a first side of the fusion zone near a first side of the fixation device, a second passageway is located on the first bone adjacent a first side of the fusion zone near a second side of the fixation device, a third passageway is located on the second bone adjacent a second side of the fusion zone near the first side of the fixation device, and a fourth passageway is located on the second bone adjacent a second side of the fusion zone near the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passageway, a second drill hole is formed in the first bone using the second passageway, a first drill hole is formed in the second bone using the third passageway, and a second drill hole is formed in the second bone using the fourth passageway, and then the drill guide is removed from the first bone and the second bone. The implant insertion device positions the implant with its first anchoring member in the first drill hole of the first bone, its second anchoring member in the second drill hole of the first bone, its third anchoring member in the first drill hole of the second bone, and its fourth anchoring member in the second drill hole of the second bone, with its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member segments while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone, the third anchoring member into the first drill hole of the second bone, and the fourth anchoring member into the second drill hole of the second bone until the bridge is located adjacent the first bone and across their fusion zones.The engagement between the implant insertion device and the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member is removed, causing the implant insertion device to jump over the bridge and release the implant, which then attempts to transition from its inserted configuration to its natural configuration. Optionally, the fixation devices are removed from the first bone and the second bone.
[0070] According to an implantation method including a drill guide having first and second passages, a fixation device is inserted into a first bone and a second bone across their fusion zones. A template is introduced into the fusion zones of the first and second bones utilizing a grip until a slot receives the fixation device therein. As a result, the first passage is located on the first bone adjacent to a first side of the fusion zone near a first side of the fixation device, and the second passage is located on the second bone adjacent to a second side of the fusion zone near a second side of the fixation device, and the body spans the fusion zone. A drill hole is formed in the first bone utilizing the first passage, while a drill hole is formed in the second bone using the second passage. The drill guide is removed from the first bone and the second bone, after which the first bone and the second bone are compressed in their fusion zones, thereby reducing their separation distance. The first anchoring member of the implant is inserted into the drill hole of the first bone and the second anchoring member of the implant is inserted into the drill hole of the second bone until the bridge of the implant is adjacent to the first bone and the second bone across their fusion zones, thereby causing the implant to transition from the insertion configuration to the natural configuration. If necessary, the fixation device is removed from the first bone and the second bone. The distance between the first and second passages is substantially equal to the distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant is in its insertion configuration plus a distance equal to the thickness of the template, so that removing the template from the fusion zone and compressing the first and second bones at their fusion zones will shorten the separation distance of the drill hole of the first bone from the drill hole of the second bone to the separation distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant is in its insertion configuration.
[0071] According to an implantation method including an alternative drill guide having first and second passages, a fixation device is inserted into a first bone and a second bone across their fusion zones. The body of the drill guide is positioned across the first bone and the second bone across their fusion zones using at least one of the first and second grips, whereby the first template is positioned adjacent to the first bone and the second template is positioned adjacent to the second bone, such that the slots of the first and second templates receive the fixation device therein. With the body of the drill guide on the first and second bones, the first passage is positioned on the first bone adjacent to the first side of the fusion zone near the first side of the fixation device and the second passage is positioned on the second bone adjacent to the second side of the fusion zone near the second side of the fixation device. A drill hole is formed in the first bone utilizing the first passageway while a drill hole is formed in the second bone utilizing the second passageway, and then the drill guide is removed from the first and second bones. A first anchoring member of the implant is inserted into the drill hole in the first bone and a second anchoring member of the implant is inserted into the drill hole in the second bone until a bridge of the implant is adjacent to the first and second bones across their fusion zones, thereby causing the implant to transition from the insertion shape to the natural shape. If necessary, the fixation device is removed from the first and second bones.
[0072] According to an implantation method including a drill guide having first, second and third passages, a fixation device is inserted into a first bone and a second bone across their fusion zones. The template is introduced into the fusion zones of the first and second bones using a grip until the slots receive the fixation device therein. As a result, the first passage is located on the first bone adjacent to the first side of the fusion zone near the first side of the fixation device, the second passage is located on the first bone adjacent to the first side of the fusion zone near the second side of the fixation device, and the third passage is located on the second bone adjacent to the second side of the fusion zone near one of the first side of the fixation device and the second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone using the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone using the third passage. The drill guide is removed from the first and second bones, after which the first and second bones are compressed at their fusion zones, thereby reducing their separation distance. The first anchoring member of the implant is inserted into the first drill hole of the first bone, the second anchoring member of the implant is inserted into the second drill hole of the first bone, and the third anchoring member of the implant is inserted into the drill hole of the second bone until the bridge of the implant abuts the first and second bones across their fusion zones, thereby causing the implant to transition from the insertion shape to the natural shape. If necessary, the fixation device is then removed from the first and second bones. The distance between the first and second passages and the third passage is substantially equal to the distance between the first and second anchoring members of the implant and the third anchoring member of the implant when the implant is in its insertion configuration plus a distance equal to the thickness of the template, such that removing the template from the fusion zone and compressing the first and second bones at their fusion zones will shorten the separation distance of the first and second drill holes of the first bone from the drill holes of the second bone to the separation distance between the first and second anchoring members of the implant and the third anchoring member of the implant when the implant is in its insertion configuration.
[0073] According to an implantation method including an alternative drill guide having first, second, and third passages, a fixation device is inserted into a first bone and a second bone across their fusion zones, and a body of the drill guide is positioned on the first bone and the second bone across their fusion zones using at least one of the first and second grips, such that the first template is positioned adjacent the first bone and the second template is positioned adjacent the second bone, such that the slots of the first and second templates receive the fixation device therein. With the body of the template on the first bone and the second bone, the first passage is located on the first bone near the first side of the fixation device and adjacent to the first side of the fusion zone, the second passage is located on the first bone near the second side of the fixation device and adjacent to the first side of the fusion zone, and the third passage is located on the second bone near one of the first side of the fixation device and the second side of the fixation device and adjacent to the second side of the fusion zone. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone using the third passage, and then the drill guide is removed from the first bone and the second bone. A first anchoring member of the implant is inserted into the first drill hole of the first bone, a second anchoring member of the implant is inserted into the second drill hole of the first bone, and a third anchoring member of the implant is inserted into the drill hole of the second bone until a bridge of the implant abuts the first and second bones across their fusion zones, whereby the implant attempts to transition from the inserted configuration to the natural configuration. If necessary, the fixation device is removed from the first and second bones.
[0074] According to an implantation method including a drill guide having first, second, third and fourth passages, a fixation device is inserted into a first bone and a second bone across their fusion zones. The template is introduced into the fusion zones of the first and second bones utilizing a grip until the slots receive the fixation device therein. As a result, the first passage is located on the first bone adjacent to the first side of the fusion zone near the first side of the fixation device, the second passage is located on the first bone adjacent to the first side of the fusion zone near the second side of the fixation device, the third passage is located on the second bone adjacent to the second side of the fusion zone near the first side of the fixation device, and the fourth passage is located on the second bone adjacent to the second side of the fusion zone near the second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, a first drill hole is formed in the second bone using the third passage, and a second drill hole is formed in the second bone using the fourth passage. The drill guide is removed from the first bone and the second bone, after which the first bone and the second bone are compressed at their fusion zones, thereby reducing their separation distance. A first anchoring member of the implant is inserted into the first drill hole of the first bone, a second anchoring member of the implant is inserted into the second drill hole of the first bone, a third anchoring member of the implant is inserted into the first drill hole of the second bone, and a fourth anchoring member of the implant is inserted into the second drill hole of the second bone, until a bridge of the implant abuts the first bone and the second bone across their fusion zones, thereby causing the implant to transition from the inserted shape to the natural shape. Optionally, the fixation devices are then removed from the first bone and the second bone.The distance between the first and third passages and the second and fourth passages is substantially equal to the distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant is in its insertion configuration plus a distance equal to the thickness of the template, such that removing the template from the fusion zone and compressing the first and second bones at their fusion zones will shorten the separation distance of the first drill hole of the first bone from the first drill hole of the second bone, and the separation distance of the second drill hole of the first bone from the second drill hole of the second bone to the separation distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant is in its insertion configuration.
[0075] According to an implantation method including an alternative drill guide having first, second, third, and fourth passages, a fixation device is inserted into a first bone and a second bone across their fusion zones, and the body of the drill guide on the first bone and the second bone is positioned across their fusion zones using at least one of the first and second grips, whereby the first template is positioned adjacent the first bone and the second template is positioned adjacent the second bone, such that the slots of the first and second templates receive the fixation device therein. With the body of the drill guide on the first bone and the second bone, a first passageway is located on the first bone adjacent a first side of the fusion zone near a first side of the fixation device, a second passageway is located on the first bone adjacent a first side of the fusion zone near a second side of the fixation device, a third passageway is located on the second bone adjacent a second side of the fusion zone near the first side of the fixation device, and a fourth passageway is located on the second bone adjacent a second side of the fusion zone near the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passageway, a second drill hole is formed in the first bone using the second passageway, a first drill hole is formed in the second bone using the third passageway, and a second drill hole is formed in the second bone using the fourth passageway, and then the drill guide is removed from the first bone and the second bone. A first anchoring member of the implant is inserted into the first drill hole of the first bone, a second anchoring member of the implant is inserted into the second drill hole of the first bone, a third anchoring member of the implant is inserted into the first drill hole of the second bone, and a fourth anchoring member of the implant is inserted into the second drill hole of the second bone until a bridge of the implant abuts the first and second bones across their fusion zones, whereby the implant attempts to transition from the inserted configuration to the natural configuration. If necessary, the fixation device is removed from the first and second bones.
[0076] SUMMARY OF THE PRESENTLY PREFERRED EMBODIMENTS It is therefore an object of the present invention to provide an implant that includes a bridge and an anchoring member that includes an outer segment of the bridge, thereby transitioning between a natural shape and an insertion shape.
[0077] Another object of the present invention is to provide an implant insertion device that engages the implant at segments of its anchoring member to restrain the implant in its insertion configuration.
[0078] It is a further object of the present invention to provide an implant insertion device that delivers an implant to a surface of a bone, bones, or bone fragments such that tamping of the implant is eliminated.
[0079] It is a further object of the present invention to provide a drill guide that facilitates the introduction of an implant into a bone, bones, or bone fragments adjacent to a fixation device that holds the bone, bones, or bone fragments in a desired alignment.
[0080] Further objects, features, and advantages of the present invention will become apparent to those skilled in the art upon consideration of the following. It will also be understood that the scope of the present invention is intended to be broad, and that any combination of any subset of the features, elements, or steps described herein is part of the intended scope of the invention. [Brief description of the drawings]
[0081] [Figure 1A] FIG. 1 is an isometric view of a shape memory implant according to a first embodiment in its natural shape. [Figure 1B] This is a side view. [Figure 1C] FIG. [Figure 1D] FIG. [Figure 1E] FIG. [Figure 2A] FIG. 1 is an isometric view of a shape memory implant according to a first embodiment in an insertion configuration. [Figure 2B] This is a side view. [Figure 2C] FIG. [Figure 2D] FIG. [Figure 2E]FIG. [Figure 2F] 1A-1C are side views illustrating alternative insertion configurations of the shape memory implant according to the first embodiment. [Figure 3A] FIG. 1 is an exploded isometric view of an implant insertion device according to a first embodiment and a shape memory implant according to the first embodiment in its natural shape. [Figure 3B] FIG. 1 is an exploded front view showing the implant insertion device and the shape memory implant. [Figure 4A] 1 is an isometric view of an implant insertion device according to a first embodiment in an unloaded position and a shape memory implant according to the first embodiment in its natural shape. [Figure 4B] FIG. 1 is a front view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 5A] 1 is an isometric view of an implant insertion device according to a first embodiment in a loaded position constraining a shape memory implant according to the first embodiment in an insertion shape. [Figure 5B] FIG. 1 is a front view showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 5C] FIG. 1 is an isometric view, partially in section, showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 5D] FIG. 5D is an isometric view, cross-sectional along line A of FIG. 5C, showing the implant insertion device in a loaded position constraining the shape memory implant in an insertion configuration. [Figure 6A] FIG. 1 is an isometric view of a body of an implant insertion device according to a first embodiment. [Figure 6B] FIG. 1 is an isometric view of a body of an implant insertion device according to a first embodiment. [Figure 6C] FIG. 2 is a front view showing the body of the implant insertion device. [Figure 6D] FIG. 13 is an end view of the body of the implant insertion device. [Figure 7A]FIG. 2 is an isometric view of an implant grip of the implant insertion device according to the first embodiment. [Figure 7B] FIG. 7B is a cross-sectional isometric view taken along line BB of FIG. 7A showing the implant grip of the implant insertion device. [Figure 7C] FIG. 7B is a top isometric view of the implant grip of the implant insertion device, taken along line CC in FIG. 7A. [Figure 7D] FIG. 7B is a bottom isometric view of the implant grip of the implant insertion device, taken along line CC in FIG. 7A. [Figure 7E] FIG. 2 is a front view showing an implant grip of the implant insertion device. [Figure 7F] FIG. 2 is a top view of an implant grip of the implant insertion device. [Figure 7G] FIG. 13 is a bottom view of the implant grip of the implant insertion device. [Figure 7H] FIG. 7D is an end view of the implant grip of the implant insertion device, taken along line DD in FIG. 7E. [Figure 7I] FIG. 7C is a front view of the implant grip of the implant insertion device, taken along line EE of FIG. 7F. [Figure 8A] FIG. 2 is a front view of an implant grip of an implant insertion device according to a first embodiment, constraining a shape memory implant in an insertion shape. [Figure 8B] 8B is a bottom view, cross-sectional along line FF of FIG. 8A, showing the implant grip of the implant insertion device constraining the shape memory implant in the insertion configuration. [Figure 9A] FIG. 1 is a cross-sectional isometric view showing an implant grip of an implant insertion device constraining a shape memory implant in an insertion configuration. [Figure 9B] FIG. 1 is a cross-sectional isometric view showing an implant grip of an implant insertion device constraining a shape memory implant in an insertion configuration. [Figure 10A]1 is an isometric view of an implant insertion device according to the second embodiment in an unloaded position and a shape memory implant according to the first embodiment in its natural shape. [Figure 10B] FIG. 1 is a front view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 10C] FIG. 13 is an end view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 10D] FIG. 13 is a bottom view of the implant insertion device in the unloaded position. [Figure 11A] 1 is an isometric view of an implant insertion device according to a second embodiment in a loaded position constraining a shape memory implant according to a first embodiment in an insertion shape. [Figure 11B] FIG. 1 is a front view showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 11C] FIG. 13 is an end view showing the implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 11D] FIG. 13 is a bottom view showing the implant insertion device in a loaded position constraining the shape memory implant in an insertion configuration. [Figure 12A] FIG. 13 is an isometric view of a body of an implant insertion device according to a second embodiment. [Figure 12B] FIG. 2 is a front view showing the body of the implant insertion device. [Figure 13A] FIG. 13 is an isometric view of an implant grip of an implant insertion device according to a second embodiment. [Figure 13B] FIG. 13 is an exploded isometric view of an implant grip of an implant insertion device according to a second embodiment. [Figure 14A] FIG. 2 is an isometric view of a shape memory implant according to a second embodiment in its natural shape. [Figure 14B] This is a side view. [Figure 14C] FIG. [Figure 14D]FIG. [Figure 14E] FIG. [Figure 15A] FIG. 2 is an isometric view of a shape memory implant according to a second embodiment in an insertion configuration. [Figure 15B] This is a side view. [Figure 15C] FIG. [Figure 15D] FIG. [Figure 15E] FIG. [Figure 15F] 13A-13C are side views illustrating alternative insertion configurations of a shape memory implant according to a second embodiment. [Figure 16A] FIG. 2 is an exploded isometric view of an implant insertion device according to the third embodiment and a shape memory implant according to the second embodiment in its natural shape. [Figure 16B] FIG. 1 is an exploded front view showing the implant insertion device and the shape memory implant. [Figure 17A] 1 is an isometric view of an implant insertion device according to the third embodiment in an unloaded position and a shape memory implant according to the second embodiment in its natural shape. [Figure 17B] FIG. 1 is a front view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 18A] 13 is an isometric view of an implant insertion device according to a third embodiment in a loaded position constraining a shape memory implant according to a second embodiment in an insertion shape. [Figure 18B] FIG. 1 is a front view showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 18C] FIG. 1 is an isometric view, partially in section, showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 18D] FIG. 18D is an isometric view taken along line G in FIG. 18C, showing the implant insertion device in a loaded position constraining the shape memory implant in an insertion configuration. [Figure 19A]13A is an isometric view of a body of an implant insertion device according to a third embodiment. FIG. [Figure 19B] 13A is an isometric view of a body of an implant insertion device according to a third embodiment. FIG. [Figure 19C] FIG. 2 is a front view showing the body of the implant insertion device. [Figure 19D] FIG. 13 is an end view of the body of the implant insertion device. [Figure 20A] FIG. 13 is an isometric view of an implant grip of an implant insertion device according to a third embodiment. [Figure 20B] FIG. 20B is an isometric view of the implant grip of the implant insertion device taken along line HH in FIG. 20A. [Figure 20C] FIG. 20B is a top isometric view of the implant grip of the implant insertion device, taken along line II of FIG. 20A. [Figure 20D] FIG. 20B is a bottom isometric view of the implant grip of the implant insertion device, taken along line II of FIG. 20A. [Figure 20E] FIG. 2 is a front view showing an implant grip of the implant insertion device. [Figure 20F] FIG. 2 is a top view of an implant grip of the implant insertion device. [Figure 20G] FIG. 13 is a bottom view of the implant grip of the implant insertion device. [Figure 20H] FIG. 20F is an end view of the implant grip of the implant insertion device, taken along line JJ in FIG. 20E. [Figure 20I] FIG. 20C is a front view of the implant grip of the implant insertion device, taken along line KK in FIG. 20F. [Figure 21A] 13 is a front view of an implant grip of an implant insertion device according to a third embodiment, constraining a shape memory implant in an insertion shape. FIG. [Figure 21B]FIG. 21B is a bottom view, cross-sectional along line LL in FIG. 21A, showing the implant grip of the implant insertion device constraining the shape memory implant in the insertion configuration. [Figure 22A] FIG. 1 is a cross-sectional isometric view showing an implant grip of an implant insertion device constraining a shape memory implant in an insertion configuration. [Figure 22B] FIG. 1 is a cross-sectional isometric view showing an implant grip of an implant insertion device constraining a shape memory implant in an insertion configuration. [Figure 23A] FIG. 13 is an isometric view of an implant insertion device according to the fourth embodiment in an unloaded position and a shape memory implant according to the second embodiment in its natural shape. [Figure 23B] FIG. 1 is a front view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 23C] FIG. 13 is an end view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 23D] FIG. 13 is a bottom view of the implant insertion device in the unloaded position. [Figure 24A] 13 is an isometric view of an implant insertion device according to a fourth embodiment in a loaded position constraining a shape memory implant according to a second embodiment in an insertion shape. [Figure 24B] FIG. 1 is a front view showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 24C] FIG. 13 is an end view showing the implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 24D] FIG. 13 is a bottom view showing the implant insertion device in a loaded position constraining the shape memory implant in an insertion configuration. [Figure 25A] FIG. 13 is an isometric view of a body of an implant insertion device according to a fourth embodiment. [Figure 25B] FIG. 2 is a front view showing the body of the implant insertion device. [Figure 26A]FIG. 13 is an isometric view of an implant grip of an implant insertion device according to a fourth embodiment. [Figure 26B] FIG. 13 is an exploded isometric view of an implant grip of an implant insertion device according to a fourth embodiment. [Figure 27A] FIG. 13 is an isometric view of a shape memory implant according to a third embodiment in its natural shape. [Figure 27B] This is a side view. [Figure 27C] FIG. [Figure 27D] FIG. [Figure 27E] FIG. [Figure 28A] FIG. 13 is an isometric view of a shape memory implant according to a third embodiment in an insertion configuration. [Figure 28B] This is a side view. [Figure 28C] FIG. [Figure 28D] FIG. [Figure 28E] FIG. [Figure 28F] 13A-13C are side views illustrating alternative insertion configurations of a shape memory implant according to a third embodiment. [Figure 29A] FIG. 13 is an exploded isometric view showing an implant insertion device according to the fifth embodiment and a shape memory implant according to the third embodiment in its natural shape. [Figure 29B] FIG. 1 is an exploded front view showing the implant insertion device and the shape memory implant. [Figure 30A] 13 is an isometric view of an implant insertion device according to the fifth embodiment in an unloaded position and a shape memory implant according to the third embodiment in its natural shape. FIG. [Figure 30B] FIG. 1 is a front view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 31A] 13 is an isometric view of an implant insertion device according to a fifth embodiment in a loaded position constraining a shape memory implant according to a third embodiment in an insertion shape. [Figure 31B] FIG. 1 is a front view showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 31C] FIG. 1 is an isometric view, partially in section, showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 31D] FIG. 31D is an isometric view taken along line G in FIG. 31C, showing the implant insertion device in a loaded position constraining the shape memory implant in an insertion configuration. [Figure 32A] FIG. 13 is an isometric view of a body of an implant insertion device according to a fifth embodiment. [Figure 32B] FIG. 13 is an isometric view of a body of an implant insertion device according to a fifth embodiment. [Figure 32C] FIG. 2 is a front view showing the body of the implant insertion device. [Fig. 32D] FIG. 13 is an end view of the body of the implant insertion device. [Figure 33A] 13 is an isometric view of an implant grip of an implant insertion device according to a fifth embodiment. FIG. [Figure 33B] FIG. 33B is an isometric view of the implant grip of the implant insertion device taken along line NN in FIG. 33A. [Figure 33C] FIG. 33B is a top isometric view of the implant grip of the implant insertion device, with the cross section taken along line OO of FIG. 33A. [Figure 33D] FIG. 33B is a bottom isometric view of the implant grip of the implant insertion device, taken along line OO in FIG. 33A. [Figure 33E] FIG. 2 is a front view showing an implant grip of the implant insertion device. [Figure 33F] FIG. 2 is a top view of an implant grip of the implant insertion device. [Figure 33G] FIG. 13 is a bottom view of the implant grip of the implant insertion device. [Fig. 33H]FIG. 33E is an end view of the implant grip of the implant insertion device, taken along line PP. [Figure 33I] FIG. 33E is a cross-sectional end view taken along line QQ of FIG. 33E showing the implant grip of the implant insertion device. [Figure 33J] FIG. 33F is a front view of the implant grip of the implant insertion device, taken along line RR. [Figure 34A] 13 is a front view of an implant grip of an implant insertion device according to a fifth embodiment, constraining a shape memory implant in an insertion shape. FIG. [Figure 34B] FIG. 33B is a bottom view, cross-sectional along line SS in FIG. 33A, showing the implant grip of the implant insertion device constraining the shape memory implant in the insertion configuration. [Figure 35A] FIG. 1 is a cross-sectional isometric view showing an implant grip of an implant insertion device constraining a shape memory implant in an insertion configuration. [Figure 35B] FIG. 1 is a cross-sectional isometric view showing an implant grip of an implant insertion device constraining a shape memory implant in an insertion configuration. [Figure 36A] 13 is an isometric view of an implant insertion device according to the sixth embodiment in an unloaded position and a shape memory implant according to the third embodiment in its natural shape. [Figure 36B] FIG. 1 is a front view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 36C] FIG. 13 is an end view showing the implant insertion device and shape memory implant in an unloaded position. [Figure 36D] FIG. 13 is a bottom view of the implant insertion device in the unloaded position. [Figure 37A] 13 is an isometric view of an implant insertion device according to a sixth embodiment in a loading position constraining a shape memory implant according to a third embodiment in an insertion shape. [Figure 37B]FIG. 1 is a front view showing an implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 37C] FIG. 13 is an end view showing the implant insertion device in a loaded position constraining a shape memory implant in an insertion configuration. [Figure 37D] FIG. 13 is a bottom view showing the implant insertion device in a loaded position constraining the shape memory implant in an insertion configuration. [Figure 38A] 13 is an isometric view showing a body of an implant insertion device according to a sixth embodiment. FIG. [Figure 38B] FIG. 2 is a front view showing the body of the implant insertion device. [Figure 39A] 13 is an isometric view of an implant grip of an implant insertion device according to a sixth embodiment. FIG. [Figure 39B] FIG. 13 is an exploded isometric view of an implant grip of an implant insertion device according to a sixth embodiment. [Figure 40A] 1 is an isometric view of a drill guide according to a first embodiment for use in implanting a shape memory implant according to the first embodiment; FIG. [Figure 40B] This is a side view. [Figure 40C] FIG. [Figure 40D] FIG. [Figure 40E] FIG. [Diagram 40F] This is a front view. [Diagram 41] 13 is an isometric view of a drill guide according to a second embodiment for use in implanting a shape memory implant according to the second embodiment. FIG. [Diagram 42] 13 is an isometric view of a drill guide according to a third embodiment for use in implanting a shape memory implant according to the third embodiment. FIG. [Figure 43A] 13 is an isometric view of a drill guide according to a fourth embodiment for use in implanting a shape memory implant according to a first embodiment. FIG. [Figure 43B] This is a side view. [Figure 43C] FIG. [Fig. 43D] FIG. [Figure 43E] FIG. [Figure 43F] This is a front view. [Diagram 44] 13 is an isometric view of a drill guide according to a fifth embodiment for use in implanting a shape memory implant according to a second embodiment. FIG. [Diagram 45] 13 is an isometric view of a drill guide according to a sixth embodiment for use in implanting a shape memory implant according to the third embodiment. FIG. [Figure 46] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using an implant insertion device according to the first embodiment; FIG. [Figure 47] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using an implant insertion device according to the first embodiment; FIG. [Figure 48] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using an implant insertion device according to the first embodiment; FIG. [Figure 49] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using an implant insertion device according to the first embodiment; FIG. [Figure 50A] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the first embodiment and an implant insertion device according to the first embodiment; FIG. [Figure 50B] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the first embodiment and an implant insertion device according to the first embodiment; FIG. [Figure 51]1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the first embodiment and an implant insertion device according to the first embodiment; FIG. [Figure 52] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the first embodiment and an implant insertion device according to the first embodiment; FIG. [Figure 53] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the first embodiment and an implant insertion device according to the first embodiment; FIG. [Figure 54] 1 is an isometric view showing the insertion of a shape memory implant according to a first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the first embodiment and an implant insertion device according to the first embodiment; FIG. [Figure 55A] 1 is an isometric view showing the insertion of a shape memory implant according to the first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the fourth embodiment and an implant insertion device according to the first embodiment. FIG. [Figure 55B] 1 is an isometric view showing the insertion of a shape memory implant according to the first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the fourth embodiment and an implant insertion device according to the first embodiment. FIG. [Figure 56] 1 is an isometric view showing the insertion of a shape memory implant according to the first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the fourth embodiment and an implant insertion device according to the first embodiment. FIG. [Figure 57] 1 is an isometric view showing the insertion of a shape memory implant according to the first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the fourth embodiment and an implant insertion device according to the first embodiment. FIG. [Figure 58]1 is an isometric view showing the insertion of a shape memory implant according to the first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the fourth embodiment and an implant insertion device according to the first embodiment. FIG. [Figure 59] 1 is an isometric view showing the insertion of a shape memory implant according to the first embodiment into a bone, multiple bones, or bone fragments using a drill guide according to the fourth embodiment and an implant insertion device according to the first embodiment. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0082] As required, detailed embodiments of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples of the present invention, which may be embodied in various forms. The figures are not necessarily to scale, and some features may be exaggerated to show details of particular components or steps.
[0083] 1A-1E show an orthopedic implant 5 according to a first embodiment in a natural shape 6, and FIGS. 2A-2E show the orthopedic implant 5 in an insertion shape 7. The implant 5 in the first embodiment may be manufactured from a shape memory material (e.g., Nitinol) having superelastic or temperature-dependent properties, which allows the implant 5 to transition between its natural shape 6 and its insertion shape 7. When the implant 5 is transformed from its natural shape 6 to its insertion shape 7, it stores energy that can be delivered to the bone, bones, or bone fragments. Due to its manufacture from a shape memory material, the implant 5 starts from its natural shape 6 and is capable of transitioning to its insertion shape 7, and when embedded in the bone, bones, or bone fragments, it attempts to transition from its insertion shape 7 to its natural shape 6, thereby allowing the implant 5 to deliver the energy stored therein to the bone, bones, or bone fragments to anchor and promote healing of the bone, bones, or bone fragments. In the first embodiment, the implant 5 attempts to transition from its insertion shape 7 to its natural shape 6, thereby continuously compressing the bone, bones, or bone fragments to promote fusion thereof.
[0084] The implant 5 includes a bridge 8 having upper and lower surfaces 9 and 10, first and second sides 11 and 12, and first and second ends 13 and 14. The first and second sides 11 and 12 and the first and second ends 13 and 14 in the first embodiment of the implant 5 include respective concave portions 11a, 12a, 13a, and 14a along at least a portion thereof. The implant 5 further includes transition portions 15 and 16 at the first end 13 of the bridge 8, and transition portions 17 and 18 at the second end 14 of the bridge 8. More specifically, in the first embodiment, the transition portion 15 is located at a corner 19 of the bridge 8 at its first end 13, and the transition portion 16 is located at a corner 20 of the bridge 8 at its first end 13. Similarly, transition portion 17 is located at corner 21 of bridge 8 at its first end 14 and transition portion 18 is located at corner 22 of bridge 8 at its first end 14 .
[0085] The implant 5 in the first embodiment comprises an anchoring member in the form of a leg 23 extending from the corner 19, in particular from the transition 15 of the corner 19, an anchoring member in the form of a leg 24 extending from the corner 20, in particular from the transition 16 of the corner 20, an anchoring member in the form of a leg 25 extending from the corner 21, in particular from the transition 17 of the corner 21, and an anchoring member in the form of a leg 26 extending from the corner 22, in particular from the transition 18 of the corner 22. In the first embodiment, the legs 23-26 are integrally formed with the bridge 8 at the respective corners 19-22, in particular at the respective transitions 15-18. Each leg 23-26 has a respective tip 27-30 and may further comprise a barb improving the pull-out resistance of the implant 5. To facilitate fixation of the bone, bones, or bone fragments by the implant 5, the implant 5 includes anchoring members in the form of legs 23-26, whereby a bridge 8 between the legs 23-26 crosses a fixation zone of the bone, bones, or bone fragments, whereby the implant 5 delivers energy to the bone, bones, or bone fragments at the fixation zone after attempting to transition from its insertion and insertion shape 7 to its natural shape 6.
[0086] The leg 23 of the first embodiment has a width 31 between sides 32 and 33 such that a segment 34 of the leg 23 extends outside of the bridge 8 at the first side 11 to provide an engagement point 35 whereby the implant engagement device will skip over the bridge 8 at the first side 11 and abut against the engagement point 35. The leg 24 of the first embodiment has a width 36 between sides 37 and 38 such that a segment 39 of the leg 24 extends outside of the bridge 8 at the second side 12 to provide an engagement point 40 whereby the implant engagement device will skip over the bridge 8 at the second side 12 and abut against the engagement point 40. The leg 25 of the first embodiment has a width 41 between sides 42 and 43 such that a segment 44 of the leg 25 extends outside of the bridge 8 at the first side 11 to provide an engagement point 45 whereby the implant engagement device will skip over the bridge 8 at the first side 11 and abut with the engagement point 45. The leg 26 of the first embodiment includes a width 46 between sides 47 and 48 such that a segment 49 of the leg 26 extends outside of the bridge 8 at the second side 12 to provide an engagement point 50 whereby the implant engagement device will skip over the bridge 8 at the second side 12 and abut with the engagement point 50.
[0087] The normal native shape of the implant 5 is its natural shape 6, as shown in Figures 1A-1E, in which the transition sections 15-18 position the bridge 8 in a natural configuration with the legs 23-26 in a natural position, whereby the legs 23-26 converge and are spaced apart a first distance. However, as shown in Figures 2A-2E, the implant 5 is deformable under the action of superelasticity or temperature-dependent shape memory to an insertion configuration 7, whereby the transition sections 15-18 deform and store energy and transition the bridge 8 from the natural configuration to an insertion configuration with the legs 23-26 in an insertion position, whereby the legs 23-26 are substantially parallel and spaced apart a second distance that is greater than the first distance. Because the insertion configuration 7 is not the normal native shape of the implant 5, the bridge 8 is typically mechanically constrained using an implant insertion device, which maintains the bridge 8 in the insertion configuration. To facilitate engagement of the implant insertion device with the implant 5, the legs 23-26 each include an engagement point 35, 40, 45, and 50 that receives the implant insertion device. The implant insertion device extends over the bridge 8 at its first side 11 and second side 12 and abuts against the engagement points 35, 40, 45, and 50. In particular, the implant insertion device extends over the bridge 8 at its first side 11 and second side 12 and abuts against the engagement points 35, 40, 45, and 50, whereby the implant insertion device engages and then retains the legs 23-26, such that the implant insertion device restrains the deformed transition portions 15-18 to maintain the implant 5 in its insertion configuration 7. After implantation into the bone, bones, or bone fragments, including heating of the implant 5 if necessary, and release of the implant insertion device, the implant 5 delivers the energy stored in the transition portions 15-18, which causes the bridge 8 to transition from the inserted configuration to a natural configuration, which in turn causes the legs 23-26 to transition from the inserted position to their natural positions, resulting in the implant 5 anchoring the bone, bones, or bone fragments by the action of a compressive force.
[0088] Although the bridge 8 of the implant 5 according to the first embodiment includes transition portions 15-18, the bridge 8 may alternatively include a transition portion 51 located in a central portion 52 of the implant 5, and thus of the bridge 8. The normal native shape of the implant 5 is the natural shape 6, as shown in Figures 1A-1E, in which the transition portion 51 places the bridge 8 in a natural configuration consisting of a closed or angled profile, whereby the first end 13 and the second end 14 are located at a first distance, and the legs 23-26 are located in a natural position, whereby the legs 23-26 converge and are spaced apart at a first distance. However, as shown in FIG. 2F, implant 5 is deformable under the action of superelasticity or temperature-dependent shape memory to an insertion configuration 53, where transition section 51 deforms to store energy and transitions bridge 8 from its natural configuration to an insertion configuration that is an open or substantially straight profile, whereby first end 13 and second end 14 are positioned at a second distance apart that is greater than the first distance, and legs 23-26 are positioned in an insertion position whereby legs 23-26 are substantially parallel and spaced apart by a second distance greater than the first distance. Because insertion configuration 53 is not the normal native shape of implant 5, bridge 8 is typically mechanically constrained using an implant insertion device that maintains bridge 8 in its insertion configuration. To facilitate engagement of implant insertion apparatus with implant 5, legs 23-26 each include engagement points 35, 40, 45, and 50 that receive an implant insertion device. The implant insertion device extends over the bridge 8 at its first side 11 and second side 12 and abuts against engagement points 35, 40, 45, and 50. In particular, the implant insertion device extends over the bridge 8 at its first side 11 and second side 12 and abuts against engagement points 35, 40, 45, and 50, whereby the implant insertion device engages and then retains the legs 23-26, such that the implant insertion device restrains the deformed transition portion 51 to maintain the implant 5 in its insertion shape 7.After implantation into the bone, bones, or bone fragments, including heating the implant 5 if necessary, and release of the implant insertion device, the implant 5 delivers the energy stored in the transition portion 51, which causes the bridge 8 to transition from its inserted configuration to its natural configuration, which causes the legs 23-26 to move from their inserted positions to their natural positions, resulting in the implant 50 applying a compressive force to the bone, bones, or bone fragments, thereby anchoring them.
[0089] One skilled in the art will appreciate that while the first embodiment of implant 5 includes either transition portions 15-18 or transition portion 51 to effect the deformation, bridge 8 of implant 5 may include both transition portions 15-18 and transition portion 51 to effect the deformation. Additionally, one skilled in the art will appreciate that while bridge 8 in the first embodiment includes an angled profile to the natural shape of implant 5, bridge 8 incorporating transition portions 15-18 may include a substantially linear profile as the natural shape of implant 5.
[0090] 3A-5D show the implant insertion device 60 engaging the implant 5 and holding it in its insertion configuration 7 or 53. FIGS. 4A-4B show the implant insertion device 60 in an unloaded position 61, prior to loading the implant 5 or after delivering the implant 5, whereby the implant 5 is released from the implant insertion device 60 without interference. FIGS. 5A-5D show the implant insertion device 60 in a loaded position 62, where the implant 5 can be loaded into the implant insertion device 60 such that the implant 5 is constrained by the implant insertion device 60 in its insertion configuration 7 or 53. The implant insertion device 60 allows the surgeon to manipulate the implant 5 and insert it into the bone, bones, or bone fragments requiring fixation. Figures 6A-6D show the body 63 of the implant insertion device 60, and Figures 7A-9B show the implant grip 64 of the implant insertion device 60 coupled to the body 63 and movable relative to the body 63 between a disengaged position 65 shown in Figures 4A-4B and an engaged position 66 shown in Figures 5A-5D.
[0091] The implant grip 64 as shown in Figures 7A-9B includes a shell 67 having a passageway 70 that allows the implant grip 64 to interface with the implant 5 and the body 63. The shell 67 includes an outer surface 68 having an upper surface 89 and a lower surface 90, and an inner surface 69 that defines a passageway 70 through the shell, such that the passageway 70 receives the implant 5 at the lower surface 90 and the passageway 70 receives the body 63 at the upper surface 89. The inner surface 69 of the shell 67, and thus of the passageway 70, includes a shape that is complementary to the implant 5, and in particular to the first and second sides 11 and 12 and the first and second ends 13 and 14 of the implant 5, such that the shell 67 grips the implant 5 and retains the implant 5 therein. More specifically, the implant 5 is inserted into the shell 67 via the passage 70 beginning at the underside 90 and is retained therein by frictional engagement between the inner surface 69 and the implant 5 such that the shell 67 surrounds the implant 5 and restrains the implant 5 in its insertion configuration 7 or 53. The inner surface 69 of the shell 67, and therefore of the passage 70, defines grooves 71-74 located at respective corners 75-78 of the inner surface 69 that receive the segments 34, 39, 44, and 49 of the legs 23-26, respectively, in complementarity with the implant 5, such that the inner surface 69 of the grooves 71-74 frictionally engage the legs 23-26 of the implant 5, respectively, thereby retaining the implant 5 within the shell 67. The inner surface 69 of each groove 71-74 further defines a retention surface 79-82 that abuts against engagement points 35, 40, 44, and 50, respectively, of the legs 23-26 to grip and then restrain the legs 23-26, thereby causing the shell 67 to retain the implant 5 in its insertion configuration 7 or 53. While the frictional engagement between the inner surface 69 and the implant 5, specifically between the inner surface 69 and the retention surfaces 79-82 at the grooves 71-74 with the legs 23-26 and their segments 34, 39, 44, and 49, retains the implant 5 within the shell 67, the shell 67 at the inner surface 69 includes projections 83-86 that grip the respective legs 23-26 on the opposite sides of the segments 34, 39, 44, and 49 to provide additional retention of the implant 5 within the shell 67.Upon insertion of the implant 5 into the passage 70, the projections 83-86 will jump over the bridge 8 at its first and second ends 13-14 via its recesses 13a and 14a, respectively, and then frictionally engage the opposing legs 23-26 of the segments 34, 39, 44, and 49, respectively, thereby helping to retain the implant 5 within the shell 67. Alternatively, the projections 83-86 may be resilient, whereby during insertion of the implant 5 into the passage 70, the projections 83-86 will move relative to the bridge 8 at its first and second ends 13-14, respectively, and then return to frictionally engage the opposing legs 23-26 of the segments 34, 39, 44, and 49, respectively, thereby helping to retain the implant 5 within the shell 67, including by acting as stops for the bridge 8 preventing accidental release of the implant 5 from the implant grips 64. The shell 67 includes detents 87 and 88 on the inner surface 69 which engage the body 63 to assist in coupling the shell 67 thereto and also limit movement of the shell 67 relative to the body 63 as the implant grip 64 moves between its disengaged position 65 and its engaged position 66.
[0092] 6A-6D includes a first end 75 defining a handle 76, a second end 77 defining an implant grip receiver 78, and a stop 84 adjacent the implant grip receiver 78 that limits movement of the implant grip 64 relative to the implant grip receiver 78. The handle 76 facilitates gripping of the implant insertion device 60 during its use in implanting an implant 5 into a bone, bones, or bone fragments requiring fixation. The implant grip receiver 78 includes a first side 80 and a second side 81, a first end 82 and a second end 83, and a tamp 79 configured to engage the bridge 8 when the implant 5 is in its insertion configuration 7 or its insertion configuration 53. The implant grip receiver 78, and thus its first and second sides 80 and 81 as well as its first and second ends 82 and 83, include a shape that is complementary to the implant grip 64, and in particular to the inner surface 69 of the shell 67, such that the implant grip receiver 78 holds the implant grip 64 thereon. More specifically, the implant grip receiver 78 is inserted into the shell 67 via the passage 70 that begins at the top surface 89, such that the implant grip receiver 78 holds the shell 67 thereon by frictional engagement between the first and second sides 80 and 81 as well as the first and second ends 82 and 83 of the implant grip receiver 78 and the inner surface 69 of the shell 67. While frictional engagement between the first side 80 and second side 81 and the first end 82 and second end 83 of the implant grip receiver 78 and the inner surface 69 of the implant grip 64 retains the shell 67 on the implant grip receiver 78, the implant grip receiver 78 defines notches 91 and 92 on both its first side 80 and second side 81 that help retain the shell 67 on the implant grip receiver 78 and further position the implant grip 64 in either its disengaged position 65 or its engaged position 66.In particular, during insertion of the implant grip receiver 78 into the shell 67, the detents 87 and 88 on the inner surface 69 of the shell 67 each move into the notch 92, thereby locking the implant grip 64 in its engaged position 66 relative to the implant grip receiver 78, or move into the notch 91, thereby locking the implant grip 64 in its disengaged position 65 relative to the implant grip receiver 78. The first end 82 and the second end 83 each define recesses 93 and 94 that prevent the implant grip receiver 78 from contacting the protrusions 83-86 when the implant grip 64 is in its disengaged position 65. In the first embodiment of the implant insertion device 60, the length of the implant grip receiver 78 of the body 63 is substantially equal to the length of the implant grip 64. With the implant insertion device 60 in its unloaded position 61, the implant grip receiver 78 is substantially fully inserted into the implant grip 64 until the implant grip 64 reaches its disengaged position 65, such that the tamp 79 of the implant grip receiver 78 is positioned on the underside 90 of the implant grip 64, such that the tamp 79 facilitates delivery of the implant 5 from the implant grip 64 into the bone, bones, or bone fragments. With the implant insertion device 60 in its loaded position 62, the implant grip receiver 78 moves within the implant grip 64 until the implant grip 64 reaches its engaged position 66, such that the implant 5 is inserted into the implant grip 64, such that the tamp 79 of the implant grip receiver 78 is positioned adjacent the bridge 8 of the implant 5.
[0093] Loading the implant 5 into the implant insertion device 60 includes the implant grip receiver 78 receiving the implant grip 64 thereon. As shown in FIGS. 3A and 3B, the implant grip receiver 78 is inserted into the implant grip 64 beginning with its tamp 79 positioned on the top surface 89 of the shell 67. After insertion into the implant grip 64, the implant grip receiver 78 moves through the passage 70 within the shell 67 such that frictional engagement between the first and second sides 80 and 81 of the implant grip receiver 78 and the first and second ends 82 and 83 of the implant grip receiver 78 holds the implant grip 64 on the implant grip receiver 78. The implant grip receiver 78 moves through the passage 70 within the shell 67 until the detents 88 and 89 slide into the notches 92, respectively, thereby locking the implant grip 64 in its engaged position 66 relative to the implant grip receiver 78. Detents 88 and 89 and notch 92 cooperate to prevent removal of implant grip 64 from implant grip receiver 78 without application of a removal force to implant grip 64 and implant grip receiver 78. After implant grip receiver 78 is inserted into implant grip 64, implant grip receiver 78 is further inserted into implant grip 64 through passage 70 of shell 67 until top surface 89 of shell 67 abuts stop 84 of body 63, causing detents 88 and 89 to disengage from notch 92 and slide into notch 91, respectively, thereby locking implant grip 64 in its disengaged position 65 relative to implant grip receiver 78.
[0094] When receiving an implant 5 in an orthopedic fixation system, the implant insertion device 60 as shown in FIGS. 4A and 4B starts in its unloaded position 61 with the implant grip 64 in its disengaged position 65. The implant 5 is mechanically transformed from its natural shape 6 to its insertion shape 7 as shown in FIGS. 2A-2E or to its insertion shape 53 as shown in FIG. 2F, so that the implant 5 stores mechanical energy. The mechanical transformation of the implant 5 may include cooling the implant 5 such that the implant 5 transitions from its austenite phase to its martensite phase before the implant 5 is loaded onto the implant insertion device 60. After transformation of the implant 5, the deformed implant 5 is positioned adjacent the implant insertion device 60 such that the implant 5 is positioned in the passage 70 inside the shell 67 of the underside 90 of the implant grip 64 such that the tamp 79 of the implant grip receiver 78 of the body 63 rests over the bridge 8 of the implant 5.
[0095] When the shell 67 of the implant grip 64 is aligned with the bridge 8 such that the implant 5 is located in the passageway 70 of the implant grip 64, a force applied to the implant grip 64 transitions the implant insertion device 60 from its unloaded position 61 to its loaded position 62, as shown in Figures 5A-5D, 8A-8B, and 9A-9B, such that the implant insertion device 60 holds the implant 5 in its insertion configuration 7 or 53. In particular, a force applied to the implant grip 64 moves the implant grip 64 from its disengaged position 65 to its engaged position 66 relative to the implant grip receiver 78 of the body 63 such that the detents 88 and 89 disengage from and slide into notches 91 and 92, respectively, thereby locking the implant grip 64 in its engaged position 66 relative to the implant grip receiver 78. Movement of the implant grip 64 from its disengaged position 65 to its engaged position 66 relative to the body 63 inserts the implant 5 into the passage 70 of the shell 67, thereby seating the implant 5 in the implant grip 64 around which the shell 67 is disposed. The passage 70 receives the implant 5 such that the shell 67 retains the implant 5 therein by an inner surface 69 of the shell 67, and thus of the passage 70, including a shape complementary to the implant 5, whereby the inner surface 69 is sized to allow introduction of the implant 5 while frictionally engaging the implant 5 as shown in FIG. 8B. The bridge 8 of the implant 5 is inserted into the passage 70 of the shell 67 at its first and second sides 11 and 12 and its first and second ends 13 and 14, while the inner surface 69 of the shell 67 retains the bridge 8 in the implant grip 64 by frictionally engaging the first and second sides 11 and 12 of the bridge 8 at their recesses 11a and 12a.When the implant 5 is inserted into the implant grip 64 while the implant grip 64 is moving from its disengaged position 65 to its engaged position 66, the shell 67 at its inner surface 69 receives therein and advances over the bridge 8 such that the grooves 71-74 of the inner surface 69 of the shell 67 receive therein the segments 34, 39, 44, and 49 of the legs 23-26, respectively, such that the inner surface 69 frictionally engages the legs 23-26 of the implant 5 at the grooves 71-74, respectively, thereby retaining the implant 5 in its insertion configuration 7 or 53 within the shell 67. Furthermore, the retaining surfaces 79-82 disposed on each of the grooves 71-74 abut against the engagement points 35, 40, 44, and 50 of the legs 23-26 to grip and subsequently restrain the legs 23-26 such that the shell 67 retains the implant 5 in its insertion configuration 7 or 53. Additionally, during insertion of the implant 5 into the passage 70 of the shell 67, the projections 83-86 on the inner surface 69 jump over the bridge 8 at its first and second ends 13 and 14, respectively, via its recesses 13a and 14a, and then frictionally engage the opposing legs 23-26, respectively, of the segments 34, 39, 44, and 49, thereby helping to retain the implant 5 in its insertion configuration 7 or 53 within the shell 67. The projections 83-86, when elastically jumping over the bridge 8, further prevent the implant 5 from being released from the implant grip 64 without the application of a push-out force applied against the implant 5 using the tamp 79 and body 63 of the implant grip receiver 78. After the implant grip 64 reaches its engagement position 66 with the detents 88 and 89 retained in the notches 92, the tamp 79 of the implant grip receiving portion 78 of the body 63 rests on the bridge 8 of the implant 5 while the grooves 71-74 and protrusions 83-86 simultaneously maintain the implant 5 within the implant grip 64 and the retaining surfaces 79-82 of each of the grooves 71-74 defined by the shell 67 restrain the legs 23-26 such that the shell 67 retains the implant 5 in its insertion shape 7 or 53.
[0096] When receiving an implant 5 within an orthopedic fixation system, the implant insertion device 60 may alternatively start in its loading position 62 with the implant grip 64 in its engagement position 66 with the detents 88 and 89 held in the notches 92. As the implant 5 is mechanically transformed from its natural shape 6 to its insertion shape 7 or 53, the transformed implant 5 is positioned adjacent the implant insertion device 60 such that the implant 5 is positioned in the passage 70 of the shell 67 within the underside 90 of the implant grip 64. After the shell 67 of the implant grip 64 is aligned with the bridge 8 such that the implant 5 is positioned in the passage 70 of the implant grip 64, the implant grip 64 is held in place until the tamp 79 of the implant grip receiver 78 of the body 63 abuts the bridge 8 of the implant 5 with the force applied to the body 63 forcing the shell 67 to fit around the implant 5, and the implant insertion device 60 holds the implant 5 in its insertion shape 7 or 53. In particular, a force applied to the body 63 with the implant grip 64 held in place inserts the implant 5 into the passage 70 of the shell 67, thereby seating the implant 5 within the implant grip 64 around which the shell 67 is disposed. The passage 70 receives the implant 5 such that the shell 67 retains the implant 5 therein by the inner surface 69 of the shell 67, and thus of the passage 70, including a shape complementary to the implant 5, whereby the inner surface 69 is sized to allow introduction of the implant 5 while frictionally engaging the implant 5 as shown in FIG. 8B. The bridge 8 of the implant 5 is inserted into the passage 70 of the shell 67 at its first and second sides 11 and 12 and its first and second ends 13 and 14, while the inner surface 69 of the shell 67 frictionally engages the first and second sides 11 and 12 of the bridge 8 at their recesses 11a and 12a to retain the bridge 8 within the implant grip 64.During insertion of the implant 5 into the implant grip 64, the shell 67 receives the bridge 8 therein at its inner surface 69 and advances over the bridge 8, whereby the grooves 71-74 of the inner surface 69 of the shell 67 receive the segments 34, 39, 44, and 49 of the legs 23-26 therein, respectively, whereby the inner surface 69 frictionally engages the legs 23-26 of the implant 5 at the grooves 71-74, respectively, thereby holding the implant 5 in its insertion shape 7 or 53 within the shell 67. Furthermore, the holding surfaces 79-82 arranged in each of the grooves 71-74 abut against the engagement points 35, 40, 44, and 50 of the legs 23-26 to grip and then restrain the legs 23-26, such that the shell 67 holds the implant 5 in its insertion shape 7 or 53. Additionally, during insertion of the implant 5 into the passage 70 of the shell 67, the projections 83-86 on the inner surface 69 jump over the bridge 8 at its first and second ends 13 and 14, respectively, via its recesses 13a and 14a, and then frictionally engage the opposing legs 23-26, respectively, of the segments 34, 39, 44, and 49, thereby helping to retain the implant 5 in its insertion configuration 7 or 53 within the shell 67. The projections 83-86, when elastically jumping over the bridge 8, further prevent the implant 5 from being released from the implant grip 64 without the application of a push-out force applied against the implant 5 using the tamp 79 and body 63 of the implant grip receiver 78. After the tamp 79 of the implant grip receiving portion 78 of the body 63 reaches and seats on the bridge 8 of the implant 5, the grooves 71-74 and protrusions 83-86 maintain the implant 5 within the implant grip 64, and the retention surfaces 79-82 of each of the grooves 71-74 defined by the shell 67 restrain the legs 23-26 such that the shell 67 retains the implant 5 in its insertion shape 7 or 53.
[0097] The implant 5 may be mechanically transformed from its natural shape 6 to its insertion shape 7 or 53 prior to its loading into the implant insertion device 60 in the orthopedic fixation system, or the implant insertion device 60 may be used during loading of the implant 5 to mechanically transform the implant 5 from its natural shape 6 to its insertion shape 7 or 53. The implant 5 in its natural shape 6 is placed adjacent the implant insertion device 60 such that the implant 5 is positioned in the passage 70 within the shell 67 of the underside 90 of the implant grip 64 such that the tamp 79 of the implant grip receiver 78 of the body 63 rests over the bridge 8 of the implant 5. Once the shell 67 of the implant grip 64 is aligned with the bridge 8 such that the implant 5 is located in the passageway 70 of the implant grip 64, a force applied to the implant grip 64 causes the implant insertion device 60 to move from its unloaded position 61 to its loaded position 62, as shown in Figures 5A-5D, 8A-8B, and 9A-9B, thereby causing the implant insertion device 60 to transition the implant 5 from its natural shape 6 to its insertion shape 7 or 53 and then retain the implant 5 in its insertion shape 7 or 53. In particular, a force applied to the implant grip 64 causes the implant grip 64 to move relative to the body 63 from its disengaged position 65 to its engaged position 66, as a result of which the detents 88 and 89 disengage from the notches 91 and slide into the notches 92, respectively, thereby locking the implant grip 64 in its engaged position 66 relative to the implant grip receiver 78. Movement of the implant grip 64 from its disengaged position 65 to its engaged position 66 relative to the body 63 inserts the implant 5 into the passage 70 of the shell 67, thereby seating the implant 5 within the implant grip 64 disposed around the shell 67.The passage 70 receives the implant 5 such that the shell 67 retains the implant 5 therein by the inner surface 69 of the shell 67, and thus the passage 70, including a shape complementary to the implant 5, whereby the inner surface 69 is sized to allow introduction of the implant 5 while frictionally engaging the implant 5 as shown in Figure 8B. The bridge 8 of the implant 5 is inserted into the passage 70 of the shell 67 at its first and second sides 11 and 12 and its first and second ends 13 and 14, while the inner surface 69 of the shell 67 retains the bridge 8 in the implant grip 64 by frictionally engaging the first and second sides 11 and 12 of the bridge 8 at their recesses 11a and 12a. When the implant 5 is inserted into the implant grip 64 while the implant grip 64 is moving from its disengaged position 65 to its engaged position 66, the shell 67 at its inner surface 69 receives therein and advances over the bridge 8 such that the grooves 71-74 of the inner surface 69 of the shell 67 receive therein the segments 34, 39, 44, and 49 of the legs 23-26, respectively, whereby the inner surface 69 frictionally engages the legs 23-26 of the implant 5 at the grooves 71-74, respectively. Furthermore, the retention surfaces 79-82 disposed on each of the grooves 71-74 abut against the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively, thereby gripping the legs 23-26 at the engagement points 35, 40, 44, and 50, respectively, and further imparting a force to the implant 5 that facilitates the transition of the implant 5 from its natural shape 6 to its insertion shape 7 or 53 as the implant grip 64 moves to its engaged position 66. Additionally, abutment of retention surfaces 79-82 of grooves 71-74 with engagement points 35, 40, 44, and 50 of legs 23-26, respectively, further constrains legs 23-26 such that shell 67 retains implant 5 in its insertion configuration 7 or 53.Additionally, during insertion of the implant 5 into the passage 70 of the shell 67, the projections 83-86 on the inner surface 69 jump over the bridge 8 at its first and second ends 13 and 14, respectively, via its recesses 13a and 14a, and then frictionally engage the opposing legs 23-26, respectively, of the segments 34, 39, 44, and 49, thereby assisting in retaining the implant 5 in its insertion configuration 7 or 53 within the shell 67. The projections 83-86, when elastically jumping over the bridge 8, further prevent the implant 5 from being released from the implant grip 64 without the application of a push-out force applied against the implant 5 using the tamp 79 and body 63 of the implant grip receiver 78. After the implant grip 64 reaches its engagement position 66 with the detents 88 and 89 retained in the notches 92, the tamp 79 of the implant grip receiving portion 78 of the body 63 rests on the bridge 8 of the implant 5 while the grooves 71-74 and protrusions 83-86 simultaneously maintain the implant 5 within the implant grip 64 and the retaining surfaces 79-82 of each of the grooves 71-74 defined by the shell 67 restrain the legs 23-26 such that the shell 67 retains the implant 5 in its insertion shape 7 or 53.
[0098] When receiving an implant 5 in an orthopedic fixation system, the implant insertion device 60 may alternatively start in its loading position 62 with the implant grip 64 in its engagement position 66 with the detents 88 and 89 held in the notches 92. The implant 5 in its natural shape 6 is positioned adjacent the implant insertion device 60 such that the implant 5 is positioned in the passage 70 of the shell 67 within the underside 90 of the implant grip 64. After the shell 67 of the implant grip 64 is aligned with the bridge 8 such that the implant 5 is positioned in the passage 70 of the implant grip 64, the implant grip 64 is held until the tamp 79 of the implant grip receiver 78 of the body 63 abuts the bridge 8 of the implant 5 with a force applied to the body 63 forcing the shell 67 to fit around the implant 5 and the implant insertion device 60 transitions the implant 5 from its natural shape 6 to its insertion shape 7 or 53 and then holds the implant 5 in its insertion shape 7 or 53. In particular, a force applied to the body 63 with the implant grip 64 held in place inserts the implant 5 into the passage 70 of the shell 67, thereby seating the implant 5 within the implant grip 64 around which the shell 67 is disposed. The passage 70 receives the implant 5 such that the shell 67 retains the implant 5 therein by the inner surface 69 of the shell 67, and thus of the passage 70, including a shape complementary to the implant 5, whereby the inner surface 69 is sized to allow introduction of the implant 5 while frictionally engaging the implant 5 as shown in FIG. 8B. The bridge 8 of the implant 5 is inserted into the passage 70 of the shell 67 at its first and second sides 11 and 12 and its first and second ends 13 and 14, while the inner surface 69 of the shell 67 frictionally engages the first and second sides 11 and 12 of the bridge 8 at their recesses 11a and 12a to retain the bridge 8 within the implant grip 64.During insertion of the implant 5 into the implant grip 64, the shell 67 receives the bridge 8 therein at its inner surface 69 and advances over the bridge 8 so that the grooves 71-74 of the inner surface 69 of the shell 67 receive the segments 34, 39, 44, and 49 of the legs 23-26 therein, whereby the inner surface 69 at the grooves 71-74 frictionally engage with the legs 23-26 of the implant 5, respectively. Additionally, the retention surfaces 79-82 disposed on each of the grooves 71-74 abut against the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively, thereby gripping the legs 23-26 at the engagement points 35, 40, 44, and 50, and further providing a force to the implant 5 that facilitates the transition of the implant 5 from its natural shape 6 to its insertion shape 7 or 53 as the implant grip 64 receives the implant 5 until the tamp 79 of the implant grip receiving portion 78 of the body 63 abuts the bridge 8 of the implant 5. Additionally, the abutment of the retention surfaces 79-82 of the grooves 71-74 with the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively, further restrains the legs 23-26 such that the shell 67 retains the implant 5 in its insertion shape 7 or 53. Additionally, during insertion of the implant 5 into the passage 70 of the shell 67, the projections 83-86 on the inner surface 69 jump over the bridge 8 at its first and second ends 13 and 14, respectively, via its recesses 13a and 14a, and then frictionally engage the opposing legs 23-26, respectively, of the segments 34, 39, 44, and 49, thereby assisting in retaining the implant 5 in its insertion configuration 7 or 53 within the shell 67. The projections 83-86, when elastically jumping over the bridge 8, further prevent the implant 5 from being released from the implant grip 64 without the application of a push-out force applied against the implant 5 using the tamp 79 and body 63 of the implant grip receiver 78.After the tamp 79 of the implant grip receiver 78 of the body 63 reaches and seats on the bridge 8 of the implant 5, the grooves 71-74 and protrusions 83-86 maintain the implant 5 within the implant grip 64, and the retaining surfaces 79-82 of each of the grooves 71-74 defined by the shell 67 restrain the legs 23-26 such that the shell 67 retains the implant 5 in its insertion shape 7 or 53.
[0099] When delivering an implant 5 to a bone, bones, or bone fragments, the implant insertion device 60 as shown in Figures 5A-5D begins in its loading position 62 with the implant grip 64 in its engaged position 66, restraining the implant 5 in its insertion configuration 7 or 53. To release the implant 5 from the implant insertion device 60, a force applied to the implant grip 64, either applied to the underside 90 of the shell 67 or directly to the implant grip 64 as described herein, advances the implant grip 64 from its engaged position 66 to its disengaged position 65 and abuts the stop 84 adjacent the implant grip receiver 78, resulting in the detents 88 and 89 sliding out of and into notches 92 and 91, respectively, thereby locking the implant grip 64 in its disengaged position 65. The tamps 79 of the implant grip receiver 78 of the body 63 rest on the bridge 8 of the implant 5, thereby preventing movement of the implant 5 relative to the implant grip 64 as the implant grip 64 progresses from its engaged position 66 to its disengaged position 65. As a result, the projections 83-86 of the inner surface 69 jump over the bridge 8 at its first end 13 and second end 14 via the recesses 13a and 14a, respectively, as the implant grip 64 moves from its engaged position 66 to its disengaged position 65, thereby releasing the opposite legs 23-26 of the segments 34, 39, 44, and 49, respectively. The projections 83-86 are inserted into the recesses 93 and 94 in the implant grip receiver 78, thereby preventing the projections 83-86 from impeding movement of the implant grip 64 relative to the implant grip receiver 78, until the tamps 79 finally reach a position adjacent the underside 90 of the shell 67. Similarly, the retaining surfaces 79-82 disposed on each of the grooves 71-74 release the engagement points 35, 40, 44, and 50, respectively, of the legs 23-26, and the grooves 71-74 on the inner surface 69 of the shell 67 are disengaged from the segments 34, 39, 44, and 49, respectively, of the legs 23-26.Furthermore, as the inner surface 69 of the shell 67 disengages from the concave portions 11a and 12a of the first and second sides 11 and 12 of the bridge 8, the inner surface 69 of the shell 67 further jumps over the bridge 8 of the implant 5 at its first and second sides 11 and 12 and its first and second ends 13 and 14, thereby causing the implant 5 to exit the passage 70 of the shell 67, and as a result, after the implant 5 is ejected from the implant grip 64, the implant 5 delivers the energy stored therein to the bone, multiple bones, or bone fragments by attempting to transition from its insertion shape 7 or 53 to its natural shape 6.
[0100] 10A-11D show the implant insertion device 100 according to the second embodiment engaging the implant 5 and holding the implant 5 in its insertion shape 7 or 53. FIGS. 10A-10D show the implant insertion device 100 in an unloaded position 101, before loading the implant 5 or after delivering the implant 5, whereby the implant 5 is released from the implant insertion device 100 without being disturbed. FIGS. 11A-11D show the implant insertion device 100 in a loading position 102, where the implant 5 can be loaded into the implant insertion device 100 such that the implant 5 is held by the implant insertion device 100 in its insertion shape 7 or 53. The implant insertion device 100 allows the surgeon to manipulate the implant 5 and insert it into the bone, bones, or bone fragments requiring fixation. 12A-12B show the body 103 of the implant insertion device 100, and FIGS. 13A-13B show the implant grip 104 of the implant insertion device 100 coupled to the body 103 and movable relative to the body 103 between a disengaged position 105 shown in FIGS. 10A-10D and an engaged position 106 shown in FIGS. 11A-11D.
[0101] The implant grip 104 as shown in Figures 13A-13B includes a first blade 107 and a second blade 108, whereby the first blade 107 and the second blade 108 are secured to an actuator 109 in an opposing relationship defining a passageway 110 therebetween. The first blade 107 and the second blade 108 in the second embodiment each include a first face 111, a second face 112, a first side 115, a second side 116, a first end 113, and a second end 114 defining a leading edge 117 between the first side 115 and the second side 116. The first end 113 of the first blade 107 and the second blade 108 includes an aperture 118 that facilitates securing the first blade 107 and the second blade 108 to the actuator 109. The passage 110 between the first blade 107 and the second blade 108 in the second embodiment receives the bridge 8 of the implant 5 therein, whereby the first blade 107 and the second blade 108 extend beyond the bridge 8 at their leading edges 117 such that the first blade 107 and the second blade 108 abut the engagement points 35, 40, 44, and 50 of the legs 23-26 at their respective first sides 115 and second sides 116, thereby restraining the implant 5 in its insertion shape 7 or 53.
[0102] 13A-13B includes a first slider 120, a second slider 121, and a spacer 122, whereby the first slider 120 and the second slider 121 are coupled with the spacer 122 in an opposing relationship to form the actuator 109 secured to the first blade 107 and the second blade 108. The first slider 120 and the second slider 121 each include a first end 123 and a second end 124, a first side 125 and a second side 126, a front face 127 defining a protrusion 128 that enables manipulation of the first slider 120 and the second slider 121, and a rear face 129 defining a pin 130 and a peg 131. The spacer 122 includes a first end 132 and a second end 133, a first side 134 and a second side 135, a front surface 136, and a rear surface 137. The spacer 122 further includes an opening 138 extending from its first side 134 to its second side 135, and a channel 139 extending from its first side 134 to its second side 135. The pins 130 of the first slider 120 and the second slider 121 are complementary in shape to the opening 138 to provide a complementary fit therewith, while the pegs 131 of the first slider 120 and the second slider 121 are complementary in shape to both the apertures 118 and the channel 139 of the first blade 107 and the second blade 108 to provide a complementary fit therewith. The first slider 120 receives the first blade 107 at its peg 131 through its aperture 118, while the first slider 120 aligns with the spacer 122 at its first side 134, so that its pin 130 is inserted into the opening 138 at the first side 134 of the spacer 122 and its peg 131, with the first blade 107 thereon, is inserted into the channel 139 at the first side 134 of the spacer 122.Similarly, the second slider 121 receives the second blade 108 at its peg 131 through its aperture 118, while the second slider 121 aligns with the spacer 122 at its second side 135, such that its pin 130 is inserted into the opening 138 at the second side 135 of the spacer 122 and its peg 131 with the second blade 108 thereon is inserted into the channel 139 at the second side 135 of the spacer 122. By fixing the first slider 120 to the first blade 107 at the first side 134 of the spacer 122 and fixing the second slider 121 to the second blade 108 at the second side 135 of the spacer 122, the implant grip 104 is constructed. The spacer 122 in the second embodiment is dimensioned such that the first blade 107 and the second blade 108 are positioned by the spacer 122 such that the passageway 110 therebetween receives the bridge 8 of the implant 5 .
[0103] The body 103 as shown in FIGS. 12A-12B includes a first end 145 defining a handle 146 that facilitates gripping of the implant insertion device 100 during its use in implanting the implant 5 into a bone, bones, or bone fragments requiring fixation. The body 103 includes a second end 147 defining a tamp 148 configured to engage the bridge 8 when the implant 5 is in its insertion configuration 7 or 53. The body 103 includes a first surface 149 and a second surface 150, which in the second embodiment have symmetrical and identical shapes. The body 103 defines a slot 151 communicating with the exterior of the body 103 that receives the implant grip 104, which is secured to the body 103 and movable between its disengaged position 105 and its engaged position 106. The slot 151 in the body 103 terminates at a first stop 153 at an upper end 152 and a second stop 155 at a lower end 154. The slot 151 of the second embodiment is sized and shaped to receive therein the spacer 122 of the actuator 109, whereby the spacer 122, along with the first and second sliders 120 and 121 and the first and second blades 107 and 108 of the actuator 109, are coupled with the body 103 to form the actuator 109 and the implant grip 104. The body 103 of the second embodiment can be a single piece or two symmetrical halves that are secured together using any suitable means, such as an adhesive.
[0104] The slot 151 in the body 103 receives the implant grip 104 and secures the implant grip 104 to the body 103 as follows: The spacer 122 of the actuator 109 is inserted into the slot 151 with the spacer 122 oriented such that its first side 134 and opening 138 and channel 139 communicate with the exterior of the slot 151 at the first face 149 of the body 103 and its second side 135 and opening 138 and channel 139 communicate with the exterior of the slot 151 at the second face 150 of the body 103. After the first slider 120 receives the first blade 107 on its peg 131 through its aperture 118, the first slider 120 is positioned on the slot 151 adjacent to the first face 149 of the body 103 so that its pin 130 is inserted into the opening 138 on the first side 134 of the spacer 122 and the peg 131, together with the first blade 107 on the peg, is inserted into the channel 139 on the first side 134 of the spacer 122. Similarly, after the second slider 121 receives the second blade 108 on its peg 131 through its aperture 118, the second slider 121 is positioned on the slot 151 adjacent to the second face 150 of the body 103 so that its pin 130 is inserted into the opening 138 on the second side 135 of the spacer 122 and the peg 131, together with the second blade 108 on the peg, is inserted into the channel 139 on the second side 135 of the spacer 122. Accordingly, the first slider 120 and the second slider 121 frictionally engage with the spacer 122 at their pins 130 and pegs 131, thereby forming the actuator 109 and coupling the actuator to the body 103, as well as positioning the first blade 107 on the first surface 149 of the body 103 and the second blade 108 on the second surface 150 of the body 103 to form the implant grip 104, although an adhesive may be introduced if necessary to help secure the first slider 120 to the second slider 121.
[0105] The first slider 120 and the second slider 121 are coupled together on the spacer 122 to form the actuator 109, which frictionally engages the body 103 to introduce resistance to the movement of the actuator 109 along the body 103, such that a force must be applied to the actuator 109 to move the implant grip 104 between its disengaged position 105 and its engaged position 106. In particular, the back surface 129 of the first slider 120 and the second slider 121 adjacent the pin 130 form a clasp 156 including a clasp surface 157, whereby the clasp surface 157 of the first slider 120 contacts the first surface 149 of the body 103 located around the slot 151, and the clasp surface 157 of the second slider 121 contacts the second surface 150 of the body 103 located around the slot 151, thereby frictionally engaging the clasp 156 with the body 103. The first surface 149 and the second surface 150 of the body 103 in the second embodiment may define a clasp receiving portion 158 specially configured to make frictional contact with a clasp surface 157 of a clasp 156 defined by the first slider 120 and the second slider 121, respectively.
[0106] Engagement of the implant grip 104 with the first end 132 of the spacer 122 of the actuator 109 located adjacent the first stop 153 of the slot 151 results in the implant grip 104 being configured in its disengaged position 105, as shown in Figures 10A-10D. Additionally, frictional engagement of the clasp 156 of the actuator 109 with the body 103 prevents unintended movement of the implant grip 104 from its disengaged position 105, such that the first blade 107 and the second blade 108 are positioned adjacent the tamp 148 at the second end 147 of the body 103, and therefore remain retracted relative to the body 103. Application of force to the actuator 109 (e.g., pushing the actuator 109) advances the implant grip 104 from its disengaged position 105 to its engaged position 106, as shown in Figures 11A-11D. More specifically, the actuator 109 moves along the body 103 toward the second stop 155 of the body 103 until the spacer 122 of the actuator 109 contacts the second stop 155 at the second end 133 such that the actuator 109 advances the first blade 107 and the second blade 108 out of the body 103 via a connection with the first blade 107 and the second blade 108. In the second embodiment, the second stop 155 and the tamp 148 define a rectangular shape similar to the bridge 8 of the implant 5, but are sized smaller than the passage 110 between the first blade 107 and the second blade 108, thereby allowing the first blade 107 and the second blade 108 to overstep the second stop 155 and the tamp 148 and extend outwardly relative to the body 103. By applying a force to the actuator 109 (e.g., pulling the actuator 109) or by applying a force to the leading edges 117 of the first blade 107 and the second blade 108, the implant grip 104 progresses from its engaged position 106 to its disengaged position 105.More specifically, the actuator 109 moves along the body 103 away from and toward the second stop 155 until the spacer 122 of the actuator 109 contacts the first stop 153 at its first end 132 such that the first blade 107 and the second blade 108 are retracted by the actuator 109 to a position at the second end 147 of the body 103 adjacent the tamp 148. When moving the implant grip 104 between its disengaged position 105 and its engaged position 106, one skilled in the art will recognize that the actuator 109, due to frictional engagement with the body 103, may be released at any point between the first stop 153 and the second stop 155 such that the first blade 107 and the second blade 108 extend from the body 103 at any position between the disengaged position 105 and the engaged position 106.
[0107] When receiving an implant 5 in an orthopedic fixation system, the implant insertion device 100 as shown in FIGS. 10A-10D starts in its unloaded position 101 with the implant grip 104 in its disengaged position 105. The implant 5 is mechanically transformed from its natural shape 6 to its insertion shape 7 as shown in FIGS. 2A-2E or to its insertion shape 53 as shown in FIG. 2F, such that the implant 5 stores mechanical energy. The mechanical transformation of the implant 5 may include cooling the implant 5 before the implant 5 is loaded onto the implant insertion device 100 such that the implant 5 transitions from its austenite phase to its martensite phase. After transformation of the implant 5, the implant insertion device 100 is positioned adjacent to the deformed implant 5 such that the tamp 148 of the body 103 contacts the bridge 8.
[0108] Once the body 103 of the implant insertion device 100 is aligned with the bridge 8 of the implant 5, a force applied to the implant grip 104 moves the implant grip 104 from its disengaged position 105 to its engaged position 106 relative to the body 103 such that the implant insertion device 100 transitions from its unloaded position 101 to its loaded position 102 as shown in FIGS. 11A-11D, whereby the implant insertion device 100 holds the implant 5 in its insertion configuration 7 or 53. The implant grip 104 extends from the body 103 such that a passage 110 between the first blade 107 and the second blade 108 allows the first blade 107 and the second blade 108 to leap over the bridge 8 at their leading edges 117 and then extend beyond the bridge such that the first blade 107 and the second blade 108 engage the legs 23-26 at their engagement points 35, 40, 44, and 50, respectively. More specifically, a force applied to the actuator 109 causes the actuator 109 to advance along the body 103 toward the second stop 155 of the body 103 until the spacer 122 of the actuator 109 contacts the second stop 155 at the second end 133, thereby causing the actuator 109 to extend the first blade 107 and the second blade 108 outside the body 103 such that the first blade 107 and the second blade 108 abut on their first side 115 and second side 116 against the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively, thereby restraining the implant 5 in its insertion shape 7 or 53. In the second embodiment, the first blade 107 and the second blade 108 may be spaced apart by a distance that allows the first blade 107 and the second blade 108 to frictionally engage with the first surface 111 and the second surface 12 of the bridge 8 at their first surfaces 111 that define the passage 110.
[0109] The implant 5 may be mechanically transformed from its natural shape 6 to its insertion shape 7 or 53 prior to its loading into the implant insertion device 100, or the implant insertion device 100 may be used during loading of the implant 5 to mechanically transform the implant 5 from its natural shape 6 to its insertion shape 7 or 53. The implant insertion device 100 is positioned in its natural shape 6 adjacent the implant 5 such that the tamp 148 of the body 103 contacts the bridge 8. When the body 103 of the implant insertion device 100 is aligned with the bridge 8 of the implant 5, a force applied to the implant grip 104 causes the implant grip 104 to move relative to the body 103. As a result, the implant grip 104 extends from the body 103 such that the passage 110 between the first blade 107 and the second blade 108 receives the bridge 8 therein, while the first blade 107 and the second blade 108 overhang the bridge 8 at their leading edges 117 and then extend beyond the bridge to engage the legs 23-26 at their engagement points 35, 40, 44, and 50. More specifically, a force applied to the actuator 109 causes the actuator 109 to progress along the body 103 toward the second stop 155 of the body 103 until the spacer 122 of the actuator 109 contacts the second stop 155 at the second end 133, thereby causing the actuator 109 to extend the first blade 107 and the second blade 108 outside the body 103 such that the first blade 107 and the second blade 108 abut on their first side 115 and second side 116 against the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively. Further, a force applied to the first blade 107 and the second blade 108 via the actuator 109 causes the first blade 107 and the second blade 108 to deform the implant 5 through abutment with the engagement points 35, 40, 44, and 50 of the legs 23-26, thereby transitioning the implant 5 from its natural shape 6 to its insertion shape 7 or 53 and constraining the implant 5 as shown in Figures 11A-11D.
[0110] When delivering an implant 5 to a bone, bones, or bone fragments, the implant insertion device 100 as shown in Figures 11A-11D begins in its loading position 102 with the implant grip 104 in its engaged position 106 constraining the implant 5 in its insertion configuration 7 or 53. To release the implant 5 from the implant insertion device 100, the implant grip 104 is advanced from its engaged position 106 to its disengaged position 105 by applying force to either the first and second blades 107 and 108 of the implant grip 104 or the leading edge 117 of the actuator 109. The implant grips 104 disengage from the implant 5 and retract relative to the body 103, thereby further releasing the legs 23-26 at their engagement points 35, 40, 44, and 50, and, if engaged, the bridge 8, such that the implant 5 attempts to transition from its insertion shape 7 or 53 to its natural shape 6, thereby delivering the energy stored therein to the bone, bones, or bone fragments. More specifically, progression of the actuator 109 along the body 103 to the first stop 154 moves the first blade 107 and the second blade 108 such that the first blade 107 and the second blade 108 release the engagement points 35, 40, 44, and 50 of the legs 23-26 at the first side 115 and the second side 116, respectively, while, if engaged, the first blade 107 and the second blade 108 also release the bridge 8 at the first face 111. The first blade 107 and the second blade 108 retract to a position at the second end 147 of the body 103 adjacent the tamp 148, thereby causing the released implant 5 to deliver the energy stored therein to the bone, bones, or bone fragments.
[0111] 14A-14E show an orthopedic implant 175 according to a second embodiment in a natural shape 176, and FIGS. 15A-15E show the orthopedic implant 175 in an insertion shape 177. The implant 175 in the second embodiment may be fabricated from a shape memory material (e.g., Nitinol) that has superelastic or temperature dependent properties such that the implant 175 transitions between its natural shape 176 and its insertion shape 177. When the implant 175 is transformed from its natural shape 176 to its insertion shape 177, it stores energy that can be delivered to a bone, bones, or bone fragments. Due to its fabrication from a shape memory material, the implant 175 can start from its natural shape 176 and transition to its insertion shape 177, and when implanted into the bone, bones, or bone fragments, the implant 175 delivers energy stored therein to the bone, bones, or bone fragments by attempting to transition from its insertion shape 177 to its natural shape 176, thereby anchoring and promoting healing of the bone, bones, or bone fragments. In a first embodiment, the implant 175 attempts to transition from its insertion shape 177 to its natural shape 176, thereby continuously compressing the bone, bones, or bone fragments and promoting fusion thereof.
[0112] The implant 175 includes a bridge 178 having an upper surface 179 and a lower surface 180, first and second sides 181 and 182, and first and second ends 183 and 184. The implant 175 further includes a transition portion 185 at the first end 183 of the bridge 178, and a transition portion 186 at the second end 184 of the bridge 178. The implant 175 in the second embodiment includes an anchoring member in the form of a leg 187 extending from the first end 183, particularly the transition portion 185, and an anchoring member in the form of a leg 188 extending from the second end 184, particularly the transition portion 186. In the second embodiment, the legs 187-188 are integrally formed with the bridge 8 at the respective first and second ends 183-184, particularly at the respective transition portions 185-186. Each leg 187-188 has a respective tip 189-190 and may further include barbs to improve pull-out resistance of the implant 175. To facilitate fixation of the bone, bones, or bone fragments by the implant 175, the implant 175 includes anchoring members in the form of legs 187-188 such that a bridge 178 between the legs 187-188 traverses a fixation zone of the bone, bones, or bone fragments such that the implant 175 delivers energy to the bone, bones, or bone fragments at the fixation zone after the implant 175 attempts to transition from its insertion and insertion configuration 177 to its natural configuration 176.
[0113] The leg 187 of the second embodiment includes a width 191 between sides 192 and 193 such that a first segment 194 of the leg 187 extends outside of the bridge 178 at its first side 181 and a second segment 195 of the leg 187 extends outside of the bridge 178 at its second side 182. The first segment 194 provides an engagement point 196 where an implant engaging device will hop over the bridge 178 at its first side 181 and abut against the engagement point 196. Similarly, the second segment 195 provides an engagement point 197 where an implant engaging device will hop over the bridge 178 at its second side 182 and abut against the engagement point 197. The leg 188 of the second embodiment includes a width 198 between sides 199 and 200 such that a first segment 201 of the leg 188 extends outside of the bridge 178 at its first side 181 and a second segment 202 of the leg 188 extends outside of the bridge 178 at its second side 182. The first segment 201 provides an engagement point 203 where an implant engaging device hops over the bridge 178 at its first side 181 and abuts against the engagement point 203. Similarly, the second segment 202 provides an engagement point 204 where an implant engaging device hops over the bridge 178 at its second side 182 and abuts against the engagement point 204. Although legs 187-188 of the second embodiment include engagement points 196-197 and 203-204, one skilled in the art will recognize that legs 187-188 may each include one engagement point 196 or 197 and 203 or 204, whereby the implant engagement device hops over bridge 178 and abuts one of the respective engagement points 196 or 197 and 203 or 204.
[0114] The normal native shape of the implant 175 is its natural configuration 176, as shown in Figures 14A-14E, in which the transition sections 185-186 position the bridge 178 in a natural configuration that positions the legs 187-188 in a natural position such that the legs 187-188 converge and are spaced apart a first distance. However, as shown in Figures 15A-15E, the implant 175 is deformable under the action of superelasticity or temperature dependent shape memory to an insertion configuration 177 in which the transition sections 185-186 deform to store energy and transition the bridge 178 from the natural configuration to an insertion configuration that positions the legs 187-188 in an insertion position such that the legs 187-188 are substantially parallel and spaced apart a second distance greater than the first distance. Because the insertion configuration 177 is not the normal native configuration of the implant 175, the bridge 178 is typically mechanically constrained using an implant insertion device, which maintains the bridge 178 in the insertion configuration. To facilitate engagement of the implant insertion device with the implant 175, the legs 187-188 include engagement points 196-197 and 203-204, respectively, that receive the implant insertion device. The implant insertion device hops over the bridge 178 at its first and second sides 181 and 182 and abuts against the engagement points 196-197 and 203-204. In particular, the implant insertion device extends over bridge 178 at its first and second sides 181 and 182 and abuts engagement points 196-197 and 203-204, whereby the implant insertion device engages and then retains legs 187-188, such that the implant insertion device restrains deformed transition portions 185-186 to maintain implant 175 in its insertion shape 177.After implantation into the bone, bones, or bone fragments, including heating of the implant 175 if necessary, and release of the implant insertion device, the implant 175 delivers the energy stored in the transition portions 185-186, causing the bridge 178 to transition from the inserted configuration to a natural configuration, which causes the legs 187-188 to transition from the inserted position to their natural positions, such that the implant 175 secures the bone, bones, or bone fragments by application of a compressive force.
[0115] Although the bridge 178 of the implant 175 according to the second embodiment includes transition portions 185-186, the bridge 178 may alternatively include a transition portion 205 located in a central portion 206 of the implant 175, and thus of the bridge 178. The normal native shape of the implant 175 is the natural shape 6, as shown in Figures 14A-14E, in which the transition portion 205 positions the bridge 178 in a natural configuration consisting of a closed or angled shape, whereby the first end 183 and the second end 184 are located at a first distance, and the legs 187 and 188 are located in a natural position, whereby the legs 187 and 188 converge and are spaced apart at a first distance. However, as shown in FIG. 15F, implant 175 is deformable under the action of superelasticity or temperature-dependent shape memory to an insertion configuration 207, where transition portion 205 deforms to store energy and transitions bridge 178 from a natural configuration to an insertion configuration that is an open or substantially straight profile, whereby first and second ends 183 and 184 are positioned at a second distance apart that is greater than the first distance, and legs 187-188 are positioned in an insertion position whereby legs 187-188 are substantially parallel and spaced apart a second distance greater than the first distance. Because insertion configuration 207 is not the normal native shape of implant 175, bridge 178 is typically mechanically constrained using an implant insertion device that maintains bridge 178 in the insertion configuration. To facilitate engagement of implant insertion device with implant 175, legs 187-188 include engagement points 196-197 and 203-204, respectively, that receive an implant insertion device. The implant insertion device flies over bridge 178 at its first and second sides 181 and 182 and abuts engagement points 196-197 and 203-204.In particular, the implant insertion device extends beyond the bridge 178 at its first and second sides 181 and 182 and abuts against the engagement points 196-197 and 203-204, whereby the implant insertion device engages and then holds the legs 187-188, such that the implant insertion device constrains the deformed transition portion 205 to maintain the implant 175 in its insertion configuration 177. After implantation into the bone, bones, or bone fragments, including heating the implant 175 if necessary, and release of the implant insertion device, the implant 175 delivers the energy stored in the transition portion 205, which causes the bridge 178 to transition from its insertion configuration to its natural configuration, which causes the legs 187-188 to move from their insertion position to their natural positions, such that the implant 175 applies a compressive force to the bone, bones, or bone fragments to anchor them.
[0116] While the second embodiment of implant 175 includes either transition portions 185-186 or transition portion 205 to effect the deformation, one skilled in the art will appreciate that bridge 178 of implant 175 may include both transition portions 185-186 and transition portion 205 to effect the deformation. Additionally, while bridge 178 in the second embodiment includes an angled profile to the natural shape of implant 175, one skilled in the art will appreciate that bridge 178 incorporating transition portions 185-186 may include a substantially linear profile as the natural shape of implant 175.
[0117] 16A-18D show an implant insertion device 208 according to a third embodiment engaging an implant 175 and holding the implant 175 in its insertion shape 177 or 207. FIGS. 17A-17B show the implant insertion device 208 in an unloaded position 209, before loading the implant 175 or after delivering the implant 175, whereby the implant 175 is released from the implant insertion device 208 without being disturbed. FIGS. 18A-18D show the implant insertion device 208 in a loaded position 210, where the implant 175 can be loaded into the implant insertion device 208 such that the implant 175 is constrained by the implant insertion device 208 in its insertion shape 177 or 207. The implant insertion device 208 allows the surgeon to manipulate the implant 175 and insert the implant 175 into the bone, bones, or bone fragments requiring fixation. 19A-19D show the body 211 of the implant insertion device 208, and FIGS. 20A-22B show the implant grip 212 of the implant insertion device 208 coupled to the body 211 and movable relative to the body 211 between a disengaged position 213 shown in FIGS. 17A-17B and an engaged position 214 shown in FIGS. 18A-18D.
[0118] The implant insertion device 208 according to the third embodiment, including its body 63 and implant grip 64, is substantially similar in design and operation to the implant insertion device 60 according to the first embodiment, and therefore, for the sake of brevity, only those differences are described herein. Moreover, those skilled in the art will recognize that like portions of the body 211 and implant grip 212 of the implant insertion device 208, labeled with like reference numerals of the body 63 and implant grip 64 of the implant insertion device 60, incorporate designs and functions as previously described in the detailed description of the implant insertion device 60 according to the first embodiment.
[0119] 20A-22B is substantially similar to implant grip 64, with the exception that implant grip 212 includes a shell 67 having an inner surface 69 defining a passageway 70 therethrough, grooves 71-74, retention surfaces 79-82, and detents 87 and 88, and interfaces with implant 175 and body 211, whereas implant grip 64 interfaces with implant 5 and body 63. In accordance therewith, inner surface 69 of shell 67, and thus passageway 70, includes a shape complementary to implant 175, and in particular to first and second sides 181 and 182 and first and second ends 183 and 184 of bridge 178, whereby shell 67 grips implant 175 and retains implant 175 in its insertion shape 177 or 207. Grooves 71-72 located at corners 75-76, respectively, of inner surface 69 receive segments 194-195 of leg 187 of implant 175 therein and frictionally engage segments 194-195, thereby retaining implant 175 within shell 67, while grooves 73-74 located at corners 77-78, respectively, of inner surface 69 receive segments 201-202 of leg 188 of implant 175 therein and frictionally engage segments 201-202, thereby retaining implant 175 within shell 67. Retention surfaces 79-80 abut engagement points 196-197 on legs 187 of implant 175 to grip and then restrain legs 187, respectively, thereby causing shell 67 to retain implant 175 in its insertion shape 177 or 207, while retention surfaces 81-82 abut engagement points 203-204 on legs 188 of implant 175 to grip and then restrain legs 188, respectively, thereby causing shell 67 to retain implant 175 in its insertion shape 177 or 207. Detents 87 and 88 engage body 211 to assist in coupling shell 67 to body 211 and also to limit movement of shell 67 relative to body 211 as implant grip 212 moves between its disengaged position 213 and its engaged position 214.The shell 67 of the implant grip 212 does not have the projections 83-86 on its inner surface 69 based on the fact that the implant 175 has only two legs 187-188.
[0120] The body 211 shown in Figures 19A-19D is substantially similar to the implant grip 63, except for the following: the body 211, including a first end 75 defining a handle 76 and a second end 77 defining an implant grip receiver 78 having a tamp 79 and a stop 84, interfaces with the implant grip 212 and the implant 175, whereas the body 63 interfaces with the implant grip 64 and the implant 5. In accordance therewith, the implant grip receiver 78, and thus its first and second sides 80 and 81 as well as its first and second ends 82 and 83, include a shape complementary to the implant grip 212, and in particular to the inner surface 69 of the shell 67, whereby the implant grip receiver 78 receives and holds the implant grip 212 thereon. The tamp 79 includes a configuration for engaging the bridge 178 when the implant 175 is in its insertion shape 177 or its insertion shape 207. The notches 91 and 92 help retain the shell 67 on the implant grip receiver 78 and also position the implant grip 212 in either its disengaged position 213 or its engaged position 214. In a third embodiment of the implant insertion device 208, the length of the implant grip receiver 78 of the body 211 is substantially equal to the length of the implant grip 212.
[0121] The implant insertion device 208 according to the third embodiment loads the implant 175, restrains the implant 175 in its insertion position 177 or 207, and transitions from its loading position 210 to its unloading position 209, thereby delivering the implant 175 to a bone, multiple bones, or bone fragments, substantially similar to the implant insertion device 60 according to the first embodiment as previously described in the detailed description herein. During loading and subsequently holding the implant 175 in the implant insertion device 208, the tamp 79 of the implant grip receiver 78 of the body 211 seats on the bridge 178 of the implant 175, while the grooves 71-74 maintain the implant 175 within the implant grip 212, and the retaining surfaces 79-82 of each of the grooves 71-74 defined by the shell 67 restrain the legs 187-188 such that the shell 67 holds the implant 175 in its insertion shape 177 or 207. When the implant 175 is delivered to a bone, multiple bones, or bone fragments, the retention surfaces 79-82 disposed on each of the grooves 71-74 release the engagement points 196-197 and 203-204, respectively, of the legs 187-188, and the grooves 71-74 on the inner surface 69 of the shell 67 are disengaged from the segments 194-195 and 201-202, respectively, of the legs 187-188. Further, as the inner surface 69 of the shell 67 disengages from the first and second sides 181 and 182 of the bridge 178, the inner surface 69 of the shell 67 further jumps over the bridge 178 of the implant 175 at its first and second sides 181 and 182 and its first and second ends 183 and 184, thereby causing the implant 175 to exit the passage 70 of the shell 67, such that after the implant 175 is ejected from the implant grip 212, the implant 175 attempts to transition from its insertion shape 177 or 207 to its natural shape 176, thereby delivering the energy stored therein to the bone, multiple bones, or bone fragments.
[0122] 23A-24D show an implant insertion device 300 according to a fourth embodiment engaging an implant 175 and holding the implant 175 in its insertion shape 177 or 207. FIGS. 23A-23D show the implant insertion device 300 in an unloaded position 301, before loading the implant 175 or after delivering the implant 175, whereby the implant 175 is released from the implant insertion device 300 without being disturbed. FIGS. 24A-24D show the implant insertion device 300 in a loaded position 302, where the implant 175 can be loaded into the implant insertion device 300 such that the implant 175 is held in its insertion shape 177 or 207 by the implant insertion device 300. The implant insertion device 300 allows the surgeon to manipulate the implant 175 and insert the implant 175 into the bone, bones, or bone fragments requiring fixation. Figures 25A-25B show the body 303 of the implant insertion device 300, and Figures 26A-26B show the implant grip 304 of the implant insertion device 300 coupled to the body 303 and movable relative to the body 303 between a disengaged position 305 shown in Figures 23A-23D and an engaged position 306 shown in Figures 24A-24D.
[0123] The implant insertion device 300 according to the fourth embodiment, including its body 103 and implant grip 104, is substantially similar in design and operation to the implant insertion device 100 according to the second embodiment, and therefore, for the sake of brevity, only those differences are described herein. Moreover, those skilled in the art will recognize that like portions of the body 303 and implant grip 304 of the implant insertion device 300, labeled with like reference numerals of the body 103 and implant grip 104 of the implant insertion device 100, incorporate designs and functions as previously described in the detailed description of the implant insertion device 100 according to the second embodiment.
[0124] The implant grip 304 shown in Figures 26A-26B is substantially similar to the implant grip 104, with the following exceptions: the implant grip 304 includes a first blade 107 and a second blade 108 defining a passageway 110 therebetween, and an actuator 109, which interfaces with the implant 175 and the body 303, whereas the implant grip 104 interfaces with the implant 175 and the body 103. Accordingly, the actuator 109 in the fourth embodiment, and more specifically its spacer 122, is dimensioned such that the first blade 107 and the second blade 108 are positioned by the spacer 122 such that the passageway 110 therebetween receives the bridge 178 of the implant 175. Accordingly, the passage 110 in the fourth embodiment is dimensioned to receive the bridge 178 of the implant 175 therein, whereby the first blade 107 and the second blade 108 extend beyond the bridge 178 at their leading edges 117 such that the first blade 107 abuts at its first side 115 and second side 116 against engagement points 196 and 203, respectively, of the legs 187-188 of the implant 175, and the second blade 108 abuts at its first side 115 and second side 116 against engagement points 197-204, respectively, of the legs 187-188 of the implant 175, thereby restraining the implant 175 in its insertion shape 177 or 207.
[0125] 25A-25B is substantially similar to the implant grip 103, with the exception that the body 303, including a first end 145 defining a handle 146 and a second end 147 having a tamp 148, interfaces with the implant grip 304 and the implant 175, whereas the body 103 interfaces with the implant grip 104 and the implant 5. Accordingly, the body 303 is dimensioned relative to the implant 175 such that the tamp 79 is configured to engage the bridge 178 when the implant 175 is in its insertion shape 177 or insertion shape 207. Similarly, the body 303, and more specifically the slot 151, is dimensioned relative to the implant grip 304 such that the spacer 122 of the actuator 109 is inserted into the slot 151 with the spacer 122 oriented such that its first side 134 and opening 138 and channel 139 communicate with the exterior of the slot 151 at the first surface 149 of the body 303, and its second side 135 and opening 138 and channel 139 communicate with the exterior of the slot 151 at the second surface 150 of the body 303. Additionally, the second stop 155 and tamp 148 of the body 303 in the fourth embodiment define a rectangular shape similar to the bridge 178 of the implant 175, but are sized smaller than the passage 110 between the first blade 107 and the second blade 108, thereby allowing the first blade 107 and the second blade 108 to extend outwardly relative to the body 303 over the second stop 155 and tamp 148.
[0126] The fourth embodiment implant insertion device 300 loads the implant 175, restrains the implant 175 in its insertion position 177 or 207, and transitions from its loading position 302 to its unloading position 301, thereby delivering the implant 175 to a bone, multiple bones, or bone fragments, substantially similar to the second embodiment implant insertion device 100 as previously described in the detailed description of this specification. During loading and subsequently holding the implant 175 into the implant insertion device 300, the tamp 148 of the body 303 seats on the bridge 178 of the implant 175 and the actuator 109 advances along the body 303 toward the second stop 155 of the body 303 until the spacer 122 of the actuator 109 contacts the second stop 155 at its second end 133, thereby causing the actuator 109 to extend the first blade 107 and the second blade 108 out of the body 303 such that the first blade 107 and the second blade 108 abut at their first and second sides 115 and 116 against the engagement points 196-197 and 203-204 of the legs 187-188 of the implant 175, respectively, thereby restraining the implant 175 in its insertion configuration 177 or 207. When delivering the implant 175 to the bone, bones, or bone fragments, the actuator 109 advances along the body 303 to its first stop 154, whereby the first blade 107 and the second blade 108 release the engagement points 196-197 and 203-204 of the legs 187-188 of the implant 175 at their first side 115 and second side 116, respectively, while the first blade 107 and the second blade 108 also release the bridges 178 at their faces 111, if engaged, resulting in the implant 175 being ejected from the implant grip 304, and the implant 175 then attempting to transition from its insertion shape 177 or 207 to its natural shape 176, thereby delivering the energy stored therein to the bone, bones, or bone fragments.
[0127] 27A-27E show an orthopedic implant 215 according to a third embodiment in a natural shape 216, and FIGS. 28A-28E show the orthopedic implant 215 in an insertion shape 217. The implant 215 in the third embodiment may be fabricated from a shape memory material (e.g., Nitinol) that has superelastic or temperature dependent properties such that the implant 215 transitions between its natural shape 216 and its insertion shape 217. When the implant 215 is transformed from its natural shape 216 to its insertion shape 217, it stores energy that can be delivered to a bone, bones, or bone fragments. Due to its fabrication from a shape memory material, the implant 215 starts from its natural shape 216 and is capable of transitioning to its insertion shape 217, and when embedded in the bone, bones, or bone fragments, it attempts to transition from its insertion shape 217 to its natural shape 216, thereby allowing the implant 215 to deliver energy stored therein to the bone, bones, or bone fragments, thereby anchoring and promoting healing of the bone, bones, or bone fragments. In a first embodiment, the implant 215 attempts to transition from its insertion shape 217 to its natural shape 216, thereby continuously compressing the bone, bones, or bone fragments, promoting their fusion.
[0128] The implant 215 includes a bridge 218 having an upper surface 219 and a lower surface 220, first and second sides 221 and 222, and first and second ends 223 and 224. The first and second sides 221 and 222 and the first and second ends 223 and 224 in the third embodiment of the implant 215 define a substantially triangular shape. The bridge 218 includes a concave portion 223a at its first end 223. The implant 215 further includes transition portions 225 and 226 at the first end 223 of the bridge 218 and a transition portion 227 at the second end 224 of the bridge 218. More specifically, in the third embodiment, the transition portion 225 is located at a corner 229 of the first end 223 of the bridge 218 and the transition portion 226 is located at a corner 230 of the first end 223 of the bridge 218. Similarly, transition portion 227 is located at corner 231 of first end 224 of bridge 218 .
[0129] The implant 215 in the third embodiment includes an anchoring member in the form of a leg 232 extending from a corner 229, particularly at a transition 225 of the corner 229, an anchoring member in the form of a leg 233 extending from a corner 230, particularly at a transition 226 of the corner 230, and an anchoring member in the form of a leg 234 extending from a corner 231, particularly at a transition 227 of the corner 231. In the third embodiment, the legs 232-234 are integrally formed with the bridge 218 at the respective corners 229-231, particularly at the respective transitions 225-227. Each leg 232-234 has a respective tip 235-237 and may further include a barb improving the pull-out resistance of the implant 215. The implant 215 includes anchoring members in the form of legs 232-234 to facilitate fixation of the implant 215 to the bone, bones, or bone fragments, whereby a bridge 218 between the legs 232-234 traverses a fixation zone of the bone, bones, or bone fragments, whereby the implant 215 delivers energy to the bone, bones, or bone fragments at the fixation zone after attempting to transition from its insertion and insertion shape 217 to its natural shape 216.
[0130] The leg 232 of the third embodiment has a width 238 between sides 239 and 240 such that a segment 241 of the leg 232 extends outwardly at a first side 221 of the bridge 218 to provide an engagement point 242 whereby the implant engagement device will overstep the bridge 218 at its first side 221 and abut with the engagement point 242. The leg 233 of the third embodiment includes a width 243 between sides 244 and 245 such that a segment 246 of the leg 233 extends outwardly at a second side 222 of the bridge 218 to provide an engagement point 247 whereby the implant engagement device will overstep the bridge 218 at its second side 222 and abut with the engagement point 247. The leg 234 of the third embodiment includes a width 248 between sides 249 and 250 such that a first segment 251 of the leg 234 extends outwardly at a first side 221 of the bridge 218 and a second segment 252 of the leg 234 extends outwardly at a second side 222 of the bridge 218. The first segment 251 provides an engagement point 253 where an implant engaging device hops over the bridge 218 at its first side 221 and abuts against the engagement point 253. Similarly, the second segment 252 provides an engagement point 254 where an implant engaging device hops over the bridge 218 at its second side 222 and abuts against the engagement point 254. Although the leg 234 of the third embodiment includes engagement points 253-254, one skilled in the art will recognize that the leg may include one engagement point 253 or 254 whereby the implant engagement device hops over the bridge 218 and engages with one of the engagement points 253 or 254.
[0131] The normal native shape of the implant 215 is its natural shape 216, as shown in Figures 27A-27E, in which the transition sections 225-227 position the bridge 218 in a natural configuration that positions the legs 232-234 in a natural position, such that the legs 232-233 converge with and are spaced apart from the leg 234 by a first distance. However, as shown in Figures 28A-28E, the implant 215 is deformable under the effect of superelasticity or temperature dependent shape memory to an insertion configuration 217, in which the transition sections 225-227 deform and store energy and transition the bridge 218 from the natural configuration to an insertion configuration that positions the legs 232-234 in an insertion position, such that the legs 232-233 are substantially parallel to the leg 234 and are spaced apart from the leg 234 by a second distance that is greater than the first distance. Because the insertion configuration 217 is not the normal native configuration of the implant 215, the bridge 218 is typically mechanically constrained using an implant insertion device, which maintains the bridge 218 in the insertion configuration. To facilitate engagement of the implant insertion device with the implant 215, the legs 232-233 include engagement points 242 and 247, respectively, and the legs 234 include engagement points 253 and 254, respectively, that receive the implant insertion device. The implant insertion device hops over the bridge 218 at its first and second sides 221 and 222 and abuts against the engagement points 242, 247, 253, and 254. In particular, the implant insertion device extends beyond bridge 218 on its first and second sides 221 and 222 and abuts engagement points 242, 247, 253, and 254, whereby the implant insertion device engages and then retains legs 232-234, such that the implant insertion device restrains deformed transition portions 225-227 to maintain implant 215 in its insertion shape 217.After implantation into the bone, bones, or bone fragments, including heating of the implant 215 if necessary, and release of the implant insertion device, the implant 215 delivers the energy stored in the transition portions 225-227, causing the bridge 218 to transition from the inserted configuration to a natural configuration, which causes the legs 232-234 to transition from the inserted position to a natural position, such that the implant 215 secures the bone, bones, or bone fragments by application of a compressive force.
[0132] Although the bridge 218 of the implant 215 according to the third embodiment includes transition portions 225-227, the bridge 218 may alternatively include a transition portion 255 located in a central portion 256 of the implant 215, and thus of the bridge 218. The normal native shape of the implant 215 according to the third embodiment is the natural shape 216, as shown in Figures 27A-27E, in which the transition portion 255 places the bridge 218 in a natural configuration consisting of a closed or angled shape, such that the first end 223 and the second end 224 are at a first distance, and the legs 232-234 are in a natural position, such that the legs 232-233 converge with and are spaced a first distance from the leg 234. 28F, implant 215 is deformable under the action of superelasticity or temperature dependent shape memory to an insertion configuration 257, where transition portion 255 deforms to store energy and transitions bridge 218 from the natural configuration to an insertion configuration that is an open or substantially straight profile, whereby first and second ends 223 and 224 are positioned at a second distance greater than the first distance, and legs 232-234 are positioned in an insertion position whereby legs 232-233 are substantially parallel to leg 234 and spaced apart from leg 234 by a second distance greater than the first distance. Because insertion configuration 257 is not the normal native shape of implant 215, bridge 218 is typically mechanically constrained using an implant insertion device that maintains bridge 218 in the insertion configuration. To facilitate engagement of the implant insertion device with implant 215, legs 232-233 include engagement points 242 and 247, respectively, and leg 234 includes engagement points 253 and 254, respectively, for receiving an implant insertion device. The implant insertion device hops over bridge 218 on its first and second sides 221 and 222 and abuts against engagement points 242, 247, 253, and 254.In particular, the implant insertion device extends beyond the bridge 218 at its first side 221 and second side 222 and abuts the engagement points 242, 247, 253, and 254, whereby the implant insertion device engages and then holds the legs 232-234, such that the implant insertion device constrains the deformed transition portion 255 to maintain the implant 215 in its insertion configuration 257. After implantation into the bone, bones, or bone fragments, including heating the implant 215 if necessary, and release of the implant insertion device, the implant 215 delivers the energy stored in the transition portion 255, which causes the bridge 218 to transition from its insertion configuration to its natural configuration, which causes the legs 232-234 to move from their insertion position to their natural positions, such that the implant 215 applies a compressive force to the bone, bones, or bone fragments to secure them.
[0133] While the third embodiment of implant 215 includes either transition portions 225-227 or transition portion 255 to effect the deformation, one skilled in the art will appreciate that bridge 218 of implant 215 may include both transition portions 225-227 and transition portion 255 to effect the deformation. Additionally, while bridge 218 in the third embodiment includes an angled profile of the natural shape of implant 215, one skilled in the art will appreciate that bridge 218 incorporating transition portions 225-227 may include a substantially linear profile as the natural shape of implant 215.
[0134] 29A-31D show the implant insertion device 400 according to the fifth embodiment engaging the implant 215 and holding the implant 215 in its insertion shape 217 or 257. FIGS. 30A-30B show the implant insertion device 400 in an unloaded position 401 before loading the implant 215 or after delivering the implant 215, whereby the implant 215 is released from the implant insertion device 400 without being disturbed. FIGS. 31A-31D show the implant insertion device 400 in a loaded position 402, where the implant 215 can be loaded into the implant insertion device 400 such that the implant 215 is constrained by the implant insertion device 400 in its insertion shape 217 or 257. The implant insertion device 400 allows the surgeon to manipulate the implant 215 and insert the implant 215 into the bone, bones, or bone fragments requiring fixation. Figures 32A-32D show the body 403 of the implant insertion device 400, and Figures 33A-35B show the implant grip 404 of the implant insertion device 400 coupled to the body 403 and movable relative to the body 403 between a disengaged position 405 shown in Figures 30A-30B and an engaged position 406 shown in Figures 31A-31D.
[0135] The implant insertion device 400 according to the fourth embodiment, including its body 63 and implant grip 64, is substantially similar in design and operation to the implant insertion device 60 according to the first embodiment, and therefore, for the sake of brevity, only those differences are described herein. Moreover, those skilled in the art will recognize that like portions of the body 403 and implant grip 404 of the implant insertion device 400, labeled with like reference numerals of the body 63 and implant grip 64 of the implant insertion device 60, incorporate designs and functions as previously described in the detailed description of the implant insertion device 60 according to the first embodiment.
[0136] The implant grip 404 shown in Figures 33A-35B is substantially similar to the implant grip 64, except that the implant grip 212 includes a shell 67 having an inner surface 69 defining a passageway 70 therethrough, grooves 71-74, retention surfaces 79-82, and detents 87 and 88, for interfacing with the implant 215 and the body 403, whereas the implant grip 64 interfaces with the implant 5 and the body 63. In accordance therewith, the inner surface 69 of the shell 67, and thus of the passageway 70, includes a substantially triangular shape in the fifth embodiment that is complementary to the implant 215, in particular the first and second sides 181 and 182 and the first and second ends 183 and 184 of the bridge 178, whereby the shell 67 grips the implant 175 and holds the implant 175 in its insertion shape 177 or 207. Grooves 71-72 located at corners 75-76, respectively, of inner surface 69 receive segments 241 and 246 of legs 232-233 of implant 215 therein and frictionally engage segments 241 and 246, respectively, thereby retaining implant 215 within shell 67, while grooves 73-74 located at corners 77-78, respectively, of inner surface 69 receive segments 251-252 of legs 234 of implant 215 and frictionally engage segments 251-252, respectively, thereby retaining implant 215 within shell 67. The retaining surfaces 79-80 abut against the engagement points 242 and 247 on the legs 232-233 of the implant 215 to grip and then restrain the legs 232-233, respectively, thereby causing the shell 67 to retain the implant 215 in its insertion shape 217 or 257, while the retaining surfaces 81-82 abut against the engagement points 253-254 on the legs 234 of the implant 215 to grip and then restrain the legs 234, respectively, thereby causing the shell 67 to retain the implant 215 in its insertion shape 217 or 257. Detents 87 and 88 engage the body 403 to assist in coupling the shell 67 to the body 63 and also to limit movement of the shell 67 relative to the body 403 as the implant grip 404 moves between its disengaged position 405 and its engaged position 406.The shell 67 of the implant grip 404 has protrusions 83-84 on its inner surface 69 based on the fact that the implant 215 has two legs 232-233 at the first end 223 of the bridge 218. The shell 67 of the implant grip 404 does not have protrusions 85-86 on its inner surface 69 based on the fact that the implant 215 has only a leg 234 at the second end 224 of the bridge 218.
[0137] The body 403 shown in Figures 32A-32D is substantially similar to the implant grip 63, with the exception that the body 403, including a first end 75 defining a handle 76 and a second end 77 defining an implant grip receiver 78 having a tamp 79 and a stop 84, interfaces with the implant grip 404 and the implant 215, whereas the body 63 interfaces with the implant grip 64 and the implant 5. In accordance with this, the implant grip receiver 78, and thus its first and second sides 80 and 81 as well as its first and second ends 82 and 83, include a substantially triangular shape in the fifth embodiment complementary to the implant grip 404, in particular a shape complementary to the inner surface 69 of the shell 67, whereby the implant grip receiver 78 receives and holds the implant grip 404 thereon. The tamp 79 includes a substantially triangular configuration in the fifth embodiment for engaging the bridge 218 when the implant 215 is in its insertion configuration 217 or its insertion configuration 257. The notches 91 and 92 help retain the shell 67 on the implant grip receiver 78 and also position the implant grip 404 in either its disengaged position 405 or its engaged position 406. In the fifth embodiment of the implant insertion device 400, the length of the implant grip receiver 78 of the body 403 is substantially equal to the length of the implant grip 404.
[0138] The fifth embodiment implant insertion device 400 loads the implant 215, restrains the implant 215 in its insertion position 217 or 257, and transitions from its loading position 402 to its unloading position 401, thereby delivering the implant 215 to a bone, multiple bones, or bone fragments, substantially similar to the first embodiment implant insertion device 60 as previously described in the detailed description herein. During loading and subsequently holding the implant 215 in the implant insertion device 400, the tamp 79 of the implant grip receiver 78 of the body 403 seats on the bridge 218 of the implant 215, while the grooves 71-74 maintain the implant 215 within the implant grip 404, and the shell 67 holds the implant 215 in its insertion shape 217 or 257 by restraining the legs 232-234 with the respective retention surfaces 79-82 of the grooves 71-74 defined by the shell 67. The projections 83-84 of the inner surface 69 pop over the bridge 218 at its first end 223 via its recesses 13a and 14a and then frictionally engage the opposing legs 232-233 of the segments 241 and 246, respectively, thereby helping to retain the implant 5 in its insertion configuration 217 or 257 within the shell 67. When the implant 175 is delivered to the bone, bones, or bone fragments, the projections 83-84 of the inner surface 69 pop over the bridge 218 at its first end 223 via the recessed sections 223a, respectively, and are inserted into the recesses 93 within the implant grip receiver 78, thereby releasing the opposing legs 232-233 of the segments 241 and 246, respectively. Similarly, the retaining surfaces 79-82 disposed on each of the grooves 71-74 release the engagement points 242, 247, 253, and 254, respectively, of the legs 232-234, and the grooves 71-74 on the inner surface 69 of the shell 67 are disengaged from the segments 241, 246, 251, and 253, respectively, of the legs 232-234.Furthermore, as the inner surface 69 of the shell 67 disengages from the first and second sides 221 and 222 of the bridge 218, the inner surface 69 of the shell 67 further jumps over the bridge 218 of the implant 215 at its first and second sides 221 and 222 and its first and second ends 223 and 224, thereby causing the implant 215 to exit the passage 70 of the shell 67, such that after the implant 215 is ejected from the implant grip 404, the implant 215 attempts to transition from its insertion shape 217 or 257 to its natural shape 216, thereby delivering the energy stored therein to the bone, multiple bones, or bone fragments.
[0139] 36A-37D show an implant insertion device 500 according to a sixth embodiment engaging an implant 215 and holding the implant 215 in its insertion shape 217 or 257. FIGS. 36A-36D show the implant insertion device 500 in an unloaded position 501, before loading the implant 215 or after delivering the implant 215, whereby the implant 215 is released from the implant insertion device 500 without being disturbed. FIGS. 37A-37D show the implant insertion device 500 in a loaded position 502, where the implant 215 can be loaded into the implant insertion device 500 such that the implant 215 is held by the implant insertion device 500 in its insertion shape 217 or 257. The implant insertion device 500 allows the surgeon to manipulate the implant 215 and insert the implant 215 into the bone, bones, or bone fragments requiring fixation. 38A-38B show the body 503 of the implant insertion device 500, and FIGS. 39A-39B show the implant grip 504 of the implant insertion device 300 coupled to the body 503 and movable relative to the body 503 between a disengaged position 505 shown in FIGS. 36A-36D and an engaged position 506 shown in FIGS. 37A-37D.
[0140] The implant insertion device 500 according to the sixth embodiment, including its body 103 and implant grip 104, is substantially similar in design and operation to the implant insertion device 100 according to the second embodiment, and therefore, for the sake of brevity, only those differences are described herein. Moreover, those skilled in the art will recognize that like portions of the body 503 and implant grip 504 of the implant insertion device 500, labeled with like reference numerals of the body 103 and implant grip 104 of the implant insertion device 100, incorporate designs and functions as previously described in the detailed description of the implant insertion device 100 according to the second embodiment.
[0141] The implant grip 504 shown in Figures 38A-38B is substantially similar to the implant grip 104, except that the implant grip 504 includes a first blade 107 and a second blade 108 defining a passageway 110 therebetween and an actuator 109 for interfacing with the implant 215 and the body 503, whereas the implant grip 104 interfaces with the implant 175 and the body 103. Accordingly, the first and second blades 107 and 108 include protrusions 510 extending therefrom at their first faces 111, which protrusions are substantially triangular in the sixth embodiment. The first faces 111 and their protrusions 510 define a passageway 110, whereby the passageway 110 is complementary in shape to the bridge 218 of the implant 215 for receiving the implant 215 therein. The actuator 109 in the fourth embodiment, and more specifically, its spacer 122, is dimensioned so that the spacer 122 positions the first blade 107 and the second blade 108 so that the passage 110 therebetween receives the bridge 218 of the implant 215. Accordingly, the passage 110 in the sixth embodiment is dimensioned to receive the bridge 218 of the implant 215 therein, whereby the first blade 107 and the second blade 108 extend beyond the bridge 218 at their leading edges 117 such that the first blade 107 abuts at its first and second sides 115 and 116 against engagement points 242 and 253 of the legs 232 and 234 of the implant 215, respectively, and the second blade 108 abuts at its first and second sides 115 and 116 against engagement points 247-254 of the legs 233 and 234 of the implant 215, respectively, thereby restraining the implant 215 in its insertion shape 217 or 257.
[0142] 38A-38B is substantially similar to the implant grip 103, with the exception that the body 503, including a first end 145 defining a handle 146 and a second end 147 having a tamp 148, interfaces with the implant grip 504 and the implant 215, whereas the body 103 interfaces with the implant grip 104 and the implant 5. Accordingly, the body 503 is dimensioned relative to the implant 215 such that the tamp 79 is configured to engage the bridge 218 when the implant 215 is in its insertion shape 217 or insertion shape 257. Similarly, the body 503, and more specifically the slot 151, is dimensioned relative to the implant grip 504 such that the spacer 122 of the actuator 109 is inserted into the slot 151 with the spacer 122 oriented such that its first side 134 and opening 138 and channel 139 communicate with the exterior of the slot 151 at the first surface 149 of the body 503, and its second side 135 and opening 138 and channel 139 communicate with the exterior of the slot 151 at the second surface 150 of the body 503. Additionally, the second stop 155 and tamp 148 of the body 503 in the sixth embodiment define a triangular shape similar to the bridge 218 of the implant 215, but are sized smaller than the passage 110 between the first blade 107 and the second blade 108, thereby allowing the first blade 107 and the second blade 108 to overshoot the second stop 155 and tamp 148 and extend externally relative to the body 503.
[0143] The sixth embodiment of the implant insertion device 500 loads the implant 215, restrains the implant 215 in its insertion position 217 or 257, and transitions from its loading position 502 to its unloading position 501, thereby delivering the implant 215 to a bone, multiple bones, or bone fragments, substantially similar to the second embodiment of the implant insertion device 100 as previously described in the detailed description of this specification. During loading and subsequently holding the implant 215 into the implant insertion device 500, the tamp 148 of the body 503 seats on the bridge 218 of the implant 215 and the actuator 109 advances along the body 503 toward the second stop 155 of the body 503 until the spacer 122 of the actuator 109 contacts the second stop 155 at its second end 133, thereby causing the actuator 109 to extend the first blade 107 and the second blade 108 out of the body 503 such that the first blade 107 and the second blade 108 abut at their first and second sides 115, 116 against the engagement points 242, 247, 253, and 254 of the legs 232-234 of the implant 215, respectively, thereby restraining the implant 215 in its insertion configuration 217 or 257. When delivering the implant 215 to the bone, bones, or bone fragments, the actuator 109 advances along the body 503 to its first stop 154, whereby the first blade 107 and the second blade 108 release the engagement points 242, 247, 253, and 254 of the legs 232-234 of the implant 215 on their first and second sides 115, 116, respectively, while the first blade 107 and the second blade 108 also release the bridges 218 on their faces 111, if engaged, resulting in the implant 215 being ejected from the implant grip 504, and subsequently the implant 215 delivering the energy stored therein to the bone, bones, or bone fragments by attempting to transition from its insertion shape 217 or 257 to its natural shape 216.
[0144] 40A-40F show a drill guide 600 according to a first embodiment for use when an implant 5 according to the first embodiment is delivered to a bone, multiple bones, or bone fragments during an orthopedic surgical procedure requiring the drilling of a drill hole adjacent to a fixation device such as a fixation pin or wire (e.g., a K-wire). The drill guide 600 in the first embodiment includes a body 601, a template 612, and a grip 614.
[0145] The body 601 includes a top 602, a bottom 603, a first end 604 and a second end 605, and a first side 606 and a second side 607. The body 601 further includes first, second, third, and fourth passages 608-611 extending from its top 602 to its bottom 603. The first passage 608 and the second passage 609 are located adjacent to the first end 604 of the body 601, while the third passage 610 and the fourth passage 611 are located adjacent to the second end 605 of the body 601. The first passage 608 and the third passage 610 are located adjacent to the first side 606 of the body 601, while the second passage 609 and the fourth passage 611 are located adjacent to the second side 607 of the body 601. Accordingly, the first, second, third and fourth passages 608-611 include complementary geometric configurations relative to the implant 5, particularly to the legs 23-26 thereof, whereby the first, second, third and fourth passages 608-611 assist in the formation of drill holes that facilitate embedding of the implant 5 into a bone, multiple bones or bone fragments.
[0146] The template 612 depends from the bottom 603 of the body 601 between a first passageway 608 and a second passageway 609 adjacent a first end 604 of the body 601 and a third passageway 610 and a fourth passageway 611 adjacent a second end 605 of the body 601. The template 612 includes a slot 613 for receiving therein a fixation device that holds a bone, bones, or bone fragments during an orthopaedic surgical procedure. The slot 613 divides the template 612 such that the first passageway 608 and the third passageway 610 are exterior to the slot 613 at a first side 615 thereof and the second passageway 609 and the fourth passageway 611 are exterior to the slot 613 at a second side 616 thereof. Thus, when the slot 613 receives a fixation device therein, the first passageway 608 and the third passageway 610 are located near the fixation device on one side thereof, while the second passageway 609 and the fourth passageway 611 are located near the fixation device on the opposite side thereof. Thus, the template 612, by their engagement with the fixation device via its slot 613, fixes the body 601 onto the bone, bones, or bone fragments with the first, second, third, and fourth passageways 608-611 proximate the fixation device, thereby allowing drill holes to be formed without contacting the fixation device.
[0147] A grip 614 extends from the body 601 at its second end 605. The grip 614 facilitates positioning and subsequent retention of the drill guide 600 on the bone, bones, or bone fragments. The grip 614 facilitates retention of the drill guide 600 on the bone, bones, or bone fragments, while the frictional engagement between the template 612 and the fixation device in the slots 613 maintains the body 601 on the bone, bones, or bone fragments, such that the grip 614 can be released without changing the position of the body 601 on the bone, bones, or bone fragments.
[0148] During an orthopaedic surgical procedure, the drill guide 600 is placed on the bone, bones, or bone fragments with its bottom 603 adjacent the bone, bones, or bone fragments by its grip 614 and its template 612 introduced into the fusion zone of the bone, bones, or bone fragments, so that its slot 613 receives therein a fixation device inserted into the bone, bones, or bone fragments. The template 612 holds the body 601 on the bone, bones, or bone fragments by frictional engagement with the fixation device, with the first passage 608 positioned on the bone, bones, or bone fragments adjacent a first side of the fusion zone near the first side of the fixation device, the second passage 609 positioned on the bone, bones, or bone fragments adjacent a first side of the fusion zone near the second side of the fixation device, the third passage 610 positioned on the bone, bones, or bone fragments adjacent a second side of the fusion zone near the first side of the fixation device, and the fourth passage 611 positioned on the bone, bones, or bone fragments adjacent a second side of the fusion zone near the second side of the fixation device. With the drill guide 600 positioned on the bone, bones, or bone fragments in this manner, the drill holes formed in the bone, bones, or bone fragments are positioned on either side of the fusion zone near the fixation device.
[0149] In the first embodiment of the drill guide 600, the first passage 608 and the second passage 609 and the third passage 610 and the fourth passage 611 are spaced apart by a distance substantially equal to the distance between legs 23-24 or legs 25-26 of the implant 5 when the implant 5 is located in its insertion position 7 or 53, such that any drill holes formed using the first passage 608 and the second passage 609 or the third passage 610 and the fourth passage 611 will receive legs 23-24 or legs 25-26 of the implant 5. However, the first and third passages 608 and 610, and the second and fourth passages 609 and 611 are spaced apart by a distance greater than the distance between legs 23 and 25, or legs 24 and 26, of the implant 5 when the implant 5 is in its insertion position 7 or 53, on the basis that introduction of the template 612 into the fusion zone of the bone, bones, or bone fragments separates the bone, bones, or bone fragments by a distance equal to the thickness 617 of the template 612. Accordingly, the distance between the first and third passages 608 and 610, and the second and fourth passages 609 and 611 in the first embodiment of the drill guide 600 is substantially equal to the distance between legs 23 and 25, or legs 24 and 26, of the implant 5 when the implant 5 is in its insertion position 7 or 53, plus a distance equal to the thickness 617 of the template 612. Therefore, after removal of the template 612 and compression of the bone, bones, or bone fragments in the fusion zone reducing their spacing by a distance equal to the thickness 617 of the template 612, any drill holes formed using the first passage 608 and the third passage 610 as well as the second passage 609 and the fourth passage 611 will receive the legs 23 and 25 or the legs 24 and 26 of the implant 5, since the drill holes are located at a distance substantially equal to the distance between the legs 23 and 25 or the legs 24 and 26 of the implant 5 when the implant 5 is in its insertion position 7 or 53.
[0150] 41 illustrates a drill guide 630 according to a second embodiment for use when the implant 175 according to the second embodiment is delivered to a bone, multiple bones, or bone fragments during an orthopedic surgical procedure that requires the drilling of a drill hole adjacent to a fixation device such as a fixation pin or wire (e.g., K-wire). The drill guide 630 in the second embodiment includes a body 631, a template 632, and a grip 634. The drill guide 630 according to the second embodiment, including the body 631, the template 642, and the grip 644, is substantially similar in design and operation to the drill guide 600 according to the first embodiment, including its body 601, the template 612, and the grip 614. Furthermore, although the body 631 of the drill guide 630 includes two passages, one skilled in the art will recognize that any similar portions of the drill guide 630 incorporate the design and functionality as previously described in the detailed description of the drill guide 600 according to the first embodiment.
[0151] The body 631 includes a top 632, a bottom 633, a first end 634 and a second end 635, and a first side 636 and a second side 637. The body 631 further includes a first passageway 638 and a second passageway 639 extending from its top 632 to its bottom 633. The first passageway 638 is located adjacent the first end 634 of the body 631, and the second passageway 639 is located adjacent the second end 635 of the body 631. Although the first passageway 638 is located adjacent the second side 637 of the body 631 and the second passageway 639 is located adjacent the first side 636 of the body 631, one skilled in the art will recognize that the locations of the first passageway 638 and the second passageway 639 relative to the first side 636 and the second side 637 may be reversed. Accordingly, the first passageway 638 and the second passageway 639 include a complementary geometric configuration relative to the implant 175, and in particular to the legs 187-188 thereof, such that the first passageway 638 and the second passageway 639 aid in the formation of drill holes that facilitate embedding of the implant 175 into a bone, multiple bones, or bone fragments.
[0152] The template 642 depends from the bottom 633 of the body 631 between a first passageway 638 adjacent a first end 634 of the body 631 and a second passageway 639 adjacent a second end 635 of the body 631. The template 642 includes a slot 643 for receiving therein a fixation device that holds a bone, bones, or bone fragments during an orthopaedic surgical procedure. The slot 643 divides the template 642 such that the second passageway 639 is located exterior to the slot 643 on a first side 645 thereof and the first passageway 638 is located exterior to the slot 643 on a second side 646 thereof. Thus, when the slot 643 receives a fixation device therein, the second passageway 639 is located near one side of the fixation device and the first passageway 638 is located near the fixation device on the opposite side. Thus, the template 642, by their engagement with the fixation device via its slots 613, fixes the body 631 onto a bone, bones, or bone fragments with the first passageway 638 and the second passageway 639 proximate the fixation device, thereby allowing drill holes to be formed without contacting the fixation device.
[0153] A grip 644 extends from the body 631 at its second end 635. The grip 644 facilitates positioning and subsequent retention of the drill guide 630 on the bone, bones, or bone fragments. The grip 644 facilitates retention of the drill guide 630 on the bone, bones, or bone fragments, while the frictional engagement between the template 642 and the fixation device in the slots 643 maintains the body 631 on the bone, bones, or bone fragments, such that the grip 644 can be released without changing the position of the body 631 on the bone, bones, or bone fragments.
[0154] During an orthopaedic surgical procedure, the drill guide 630 is placed on the bone, bones, or bone fragments with its bottom 633 adjacent the bone, bones, or bone fragments by its grip 644 and its template 642 introduced into the fusion zone of the bone, bones, or bone fragments such that its slot 643 receives therein a fixation device inserted into the bone, bones, or bone fragments. The template 642 holds the body 631 on the bone, bones, or bone fragments by frictional engagement with the fixation device, and positions the first passage 638 on the bone, bones, or bone fragments adjacent a first side of the fixation device and adjacent a first side of the fusion zone, and positions the second passage 639 on the bone, bones, or bone fragments adjacent a second side of the fixation device and adjacent a second side of the fusion zone. With the drill guide 630 so positioned on the bone, bones, or bone fragments, drill holes formed in the bone, bones, or bone fragments are positioned on either side of the fusion zone near the fixation device.
[0155] In the second embodiment of the drill guide 630, the first passage 638 and the second passage 639 are spaced apart by a distance greater than the distance between the legs 187 of the implant 175 when the implant 175 is in its insertion position 177 or 207, on the basis that introduction of the template 642 into the fusion zone of the bone, bones, or bone fragments separates the bone, bones, or bone fragments by a distance equal to the thickness 647 of the template 642. Accordingly, the distance between the first passage 638 and the second passage 639 in the second embodiment of the drill guide 630 is substantially equal to the distance between the legs 187 and 188 of the implant 175 when the implant 175 is in its insertion position 177 or 207, plus a distance equal to the thickness 647 of the template 642. Therefore, after removal of the template 642 and compression of the bone, bones, or bone fragments in the fusion zone, shortening the spacing by a distance equal to the thickness 647 of the template 642, any drill holes formed using the first passage 638 and the second passage 639 will receive the legs 187 and 188 of the implant 175, since the drill holes will be located at a distance substantially equal to the distance between the legs 187 and 188 of the implant 175 when the implant 175 is in its insertion position 177 or 207.
[0156] 42 illustrates a drill guide 650 according to a third embodiment for use when the implant 215 according to the third embodiment is delivered to a bone, multiple bones, or bone fragments during an orthopedic surgical procedure that requires the drilling of a drill hole adjacent to a fixation device such as a fixation pin or wire (e.g., K-wire). The drill guide 650 in the third embodiment includes a body 651, a template 662, and a grip 664. The drill guide 650 according to the third embodiment, including the body 651, the template 662, and the grip 664, is substantially similar in design and operation to the drill guide 600 according to the first embodiment, including its body 601, the template 612, and the grip 614. Furthermore, although the body 651 of the drill guide 650 includes three passages, one skilled in the art will recognize that any similar portions of the drill guide 650 incorporate the design and functionality as previously described in the detailed description of the drill guide 600 according to the first embodiment.
[0157] The body 651 includes a top 652, a bottom 653, a first end 654 and a second end 655, and a first side 656 and a second side 657. The body 651 further includes first, second, and third passages 658-660 extending from its top 652 to its bottom 653. The first passage 658 and the second passage 659 are located adjacent the first end 654 of the body 651, and the third passage 660 is located adjacent the second end 655 of the body 651.
[0158] The first passageway 658 and the third passageway 660 are located adjacent a first side 656 of the body 651 and the second passageway 659 is located adjacent a second side 657 of the body 651, although one skilled in the art will recognize that the location of the third passageway 660 may be moved to the second side 657. Accordingly, the first, second, and third passageways 658-660 include complementary geometric configurations with respect to the implant 217, and in particular with respect to the legs 232-234 thereof, whereby the first, second, and third passageways 658-660 aid in the formation of drill holes that facilitate embedding of the implant 217 into a bone, multiple bones, or bone fragments.
[0159] The template 662 depends from a bottom 653 of the body 651 between a first passageway 658 and a second passageway 659 adjacent a first end 654 of the body 651 and a third passageway 660 adjacent a second end 655 of the body 651. The template 662 includes a slot 663 for receiving therein a fixation device that holds a bone, bones, or bone fragments during an orthopaedic surgical procedure. The slot 663 divides the template 662 such that the first passageway 658 and the third passageway 660 are located outside the slot 663 on a first side 665 thereof and the second passageway 659 is located outside the slot 663 on a second side 666 thereof. As such, when the slot 663 receives a fixation device therein, the first passageway 658 and the third passageway 660 are located near the fixation device on one side thereof while the second passageway 659 is located near the fixation device on the opposite side thereof. Thus, the template 662, by their engagement with a fixation device via its slots 663, secures the body 651 onto a bone, bones, or bone fragments with the first, second, and third passages 658-660 proximate the fixation device, thereby allowing drill holes to be formed without contacting the fixation device.
[0160] A grip 664 extends from the body 651 at its second end 655. The grip 664 facilitates positioning and subsequent retention of the drill guide 650 on the bone, bones, or bone fragments. The grip 664 facilitates retention of the drill guide 650 on the bone, bones, or bone fragments, while the frictional engagement between the template 662 and the fixation device in the slots 663 maintains the body 651 on the bone, bones, or bone fragments, such that the grip 664 can be released without changing the position of the body 651 on the bone, bones, or bone fragments.
[0161] During an orthopaedic surgical procedure, the drill guide 650 is placed on the bone, bones, or bone fragments with its bottom 653 adjacent the bone, bones, or bone fragments by its grip 664 and its template 662 introduced into the fusion zone of the bone, bones, or bone fragments such that its slot 664 receives therein a fixation device inserted into the bone, bones, or bone fragments. The template 662 holds the body 651 on the bone, bones, or bone fragments by frictional engagement with the fixation device, and positions the first passage 658 on the bone, bones, or bone fragments adjacent to the first side of the fusion zone near the first side of the fixation device, the second passage 659 on the bone, bones, or bone fragments adjacent to the first side of the fusion zone near the second side of the fixation device, and the third passage 660 on the bone, bones, or bone fragments adjacent to the second side of the fusion zone near the first side of the fixation device. With the drill guide 650 so positioned on the bone, bones, or bone fragments, drill holes formed in the bone, bones, or bone fragments are positioned on either side of the fusion zone near the fixation device.
[0162] In the third embodiment of the drill guide 650, the first passage 658 and the second passage 659 are spaced apart a distance substantially equal to the distance between the legs 232-233 of the implant 215 when the implant 215 is in its insertion position 217 or 257, such that any drill holes formed using the first passage 658 and the second passage 659 receive the legs 232-223 of the implant 215. However, the first passage 658 and the second passage 659 are spaced apart from the third passage 660 a distance greater than the distance between the legs 232-233 and the legs 234 of the implant 215 when the implant 215 is in its insertion position 217 or 257, based on the fact that introduction of the template 662 into the fusion zone of the bone, bones, or bone fragments separates the bone, bones, or bone fragments by a distance equal to the thickness 667 of the template 662. Accordingly, the distance between the first and second passages 658, 659 and the third passage 660 in the third embodiment of the drill guide 650 is substantially equal to the distance between legs 232-233 and leg 234 of the implant 215 when the implant 215 is in its insertion position 217 or 257 plus a distance equal to the thickness 667 of the template 662. Therefore, after removal of the template 662 and compression of the bone, bones, or bone fragments in the fusion zone, shortening the spacing by a distance equal to the thickness 667 of the template 662, any drill holes formed using the first passage 658 and the second passage 659 and the third passage 660 will receive the legs 232-233 and legs 234 of the implant 215, since the drill holes will be located at a distance substantially equal to the distance between the legs 232-233 and legs 234 of the implant 215 when the implant 215 is in its insertion position 217 or 257.
[0163] 43A-43F show a drill guide 900 according to a fourth embodiment for use when an implant 5 according to the first embodiment is delivered to a bone, multiple bones, or bone fragments during an orthopedic surgical procedure requiring the drilling of a drill hole adjacent to a fixation device such as a fixation pin or wire (e.g., a K-wire). The drill guide 900 in the fourth embodiment includes a body 901, a first template 912 and a second template 922, and a first grip 914 and a second grip 924.
[0164] The body 901 includes a top 902, a bottom 903, a first end 904 and a second end 905, and a first side 906 and a second side 907. The body 901 further includes first, second, third, and fourth passages 908-911 extending from its top 902 to its bottom 903. The first passage 908 and the second passage 909 are located adjacent to the first end 904 of the body 901, and the third passage 910 and the fourth passage 911 are located adjacent to the second end 905 of the body 901. The first passage 908 and the third passage 910 are located adjacent to the first side 906 of the body 901, and the second passage 909 and the fourth passage 911 are located adjacent to the second side 907 of the body 901. Accordingly, the first, second, third and fourth passages 908-911 include complementary geometric configurations relative to the implant 5, particularly to the legs 23-26 thereof, whereby the first, second, third and fourth passages 908-911 assist in the formation of drill holes that facilitate embedding of the implant 5 into a bone, multiple bones or bone fragments.
[0165] A first grip 914 extends from the body 901 at its first end 904. Similarly, a second grip 924 extends from the body 901 at its second end 905. The first grip 914 and the second grip 924 facilitate positioning and subsequent retention of the drill guide 900 on a bone, bones, or bone fragments.
[0166] A first template 912 depends from a first grip 914 below the bottom 903 of the body 901 at a location opposite the first end 904. A second template 922 depends from a second grip 924 below the bottom 903 of the body 901 at a location opposite the second end 905. The first template 912 and second template 922 each include a slot 913 and a slot 923 for receiving a fixation device therein that holds a bone, bones, or bone fragments during an orthopaedic surgical procedure. The slots 913 and 923 divide the first template 912 and the second template 922, respectively, such that the first passageway 908 and the third passageway 910 are located outside the slots 913 and 923 on their first sides 915 and 925, and the second passageway 909 and the fourth passageway 911 are located outside the slots 913 and 923 on their second sides 916 and 926. Thus, when the slots 913 and 923 receive a fixation device therein, the first passageway 908 and the third passageway 910 are located near the fixation device on one side thereof, while the second passageway 909 and the fourth passageway 911 are located near the fixation device on the opposite side thereof. Thus, the first and second templates 912 and 922, by engagement with the fixation device via their respective slots 913 and 923, secure the body 901 on the bone, bones, or bone fragments with the first, second, third, and fourth passages 908-911 proximate the fixation device, thereby allowing drill holes to be formed without contacting the fixation device. The first and second grips 914 and 922 facilitate holding the drill guide 900 on the bone, bones, or bone fragments, while the frictional engagement between the first and second templates 912 and 922 and the fixation device at the slots 913 and 923 maintains the body 901 on the bone, bones, or bone fragments, such that the first and second grips 914 and 922 may be released without changing the position of the body 901 on the bone, bones, or bone fragments.
[0167] During an orthopaedic surgical procedure, the drill guide 900, via its first grip 914 and second grip 924, is positioned on the bone, bones, or bone fragments in their fusion zone with its bottom 903 adjacent to the bone, bones, or bone fragments and its first template 912 and second template 922 positioned on either side of the bone, bones, or bone fragments, such that its slots 913 and slots 923 receive a fixation device inserted into the bone, bones, or bone fragments. The first template 912 and the second template 922 hold the body 901 on the bone, bones, or bone fragments by frictional engagement with the fixation device, with the first passageway 908 positioned on the bone, bones, or bone fragments near the first side of the fixation device and adjacent to the first side of the fusion zone, the second passageway 909 positioned on the bone, bones, or bone fragments near the second side of the fixation device and adjacent to the first side of the fusion zone, the third passageway 910 positioned on the bone, bones, or bone fragments near the first side of the fixation device and adjacent to the second side of the fusion zone, and the fourth passageway 911 positioned on the bone, bones, or bone fragments near the second side of the fixation device and adjacent to the second side of the fusion zone. With the drill guide 900 positioned on the bone, bones, or bone fragments in this manner, the drill holes formed in the bone, bones, or bone fragments are positioned near the fixation device and on either side of the fusion zone.
[0168] In the fourth embodiment of the drill guide 900, the first and second passages 908 and 909 and the third and fourth passages 910 and 911 are spaced apart by a distance substantially equal to the distance between legs 23-24 or legs 25-26 of the implant 5 when the implant 5 is in its insertion position 7 or 53, such that any drill holes formed using the first and second passages 908 and 909 or the third and fourth passages 910 and 911 will receive legs 23-24 or legs 25-26 of the implant 5. Similarly, the first passage 908 and the third passage 910 and the second passage 909 and the fourth passage 911 are spaced apart by a distance substantially equal to the distance between legs 23 and 25 or legs 24 and 26 of the implant 5 when the implant 5 is in its insertion position 7 or 53, such that any drill holes formed using the first passage 908 and the third passage 910 or the second passage 909 and the fourth passage 911 will receive legs 23 and 25 or legs 24 and 26 of the implant 5.
[0169] 44 shows a drill guide 930 according to a fifth embodiment used when the implant 175 according to the second embodiment is delivered to a bone, multiple bones, or bone fragments during an orthopedic surgical procedure that requires drilling of a drill hole near a fixation device such as a fixation pin or wire (e.g., K-wire). The drill guide 930 of the fifth embodiment includes a body 931, a first template 940 and a second template 942, and a first grip 944 and a second grip 945. The drill guide 930 according to the fifth embodiment, including its body 931, the first template 940 and the second template 942, and the first grip 944 and the second grip 945, is substantially similar to the drill guide 900 according to the fourth embodiment, including its body 901, the first template 912 and the second template 922, and the first grip 914 and the second grip 924. Further, although the body 931 of the drill guide 930 includes two passages, one skilled in the art will recognize that any similar portion of the drill guide 930 incorporates the design and functionality as previously described in the detailed description of the drill guide 900 according to the fourth embodiment.
[0170] The body 931 includes a top 932, a bottom 933, a first end 934 and a second end 935, and a first side 936 and a second side 937. The body 931 further includes a first passageway 938 and a second passageway 939 extending from its top 932 to its bottom 933. The first passageway 938 is located adjacent the first end 934 of the body 931, and the second passageway 939 is located adjacent the second end 935 of the body 931. Although the first passageway 938 is located adjacent the second side 937 of the body 931 and the second passageway 939 is located adjacent the first side 936 of the body 931, one skilled in the art will recognize that the locations of the first passageway 938 and the second passageway 939 relative to the first side 936 and the second side 937 may be reversed. Accordingly, the first passageway 938 and the second passageway 939 include a complementary geometric configuration with respect to the implant 175, and in particular with respect to the legs 187-188 thereof, such that the first passageway 938 and the second passageway 939 aid in the formation of drill holes that facilitate embedding of the implant 175 into a bone, multiple bones, or bone fragments.
[0171] A first grip 944 extends from the body 931 at its first end 934. Similarly, a second grip 945 extends from the body 931 at its second end 935. The first grip 944 and second grip 945 facilitate positioning and subsequent retention of the drill guide 930 on a bone, bones, or bone fragments.
[0172] The first template 940 depends from a first grip 944 below the bottom 933 of the body 931 at a location opposite the first end 934. The second template 942 depends from a second grip 945 below the bottom 933 of the body 931 at a location opposite the second end 935. The first template 940 and the second template 942 each include a slot 941 and a slot 943 for receiving a fixation device therein that holds a bone, bones, or bone fragments during an orthopaedic surgical procedure. The slots 941 and 943 divide the first template 940 and the second template 942, respectively, such that the second passage 639 is located exterior to the slots 941 and 943 at first sides 946 and 948 thereof and the first passage 638 is located exterior to the slots 941 and 943 at second sides 947 and 949 thereof. Thus, when the slots 941 and 943 receive a fixation device therein, the second passageway 639 is located near one side of the fixation device and the first passageway 638 is located near the opposite side of the fixation device. Thus, the first template 940 and the second template 942, by their engagement with the fixation device via the respective slots 941 and 943, secure the body 931 onto the bone, bones, or bone fragments with the first passageway 638 and the second passageway 639 proximate the fixation device, thereby allowing drill holes to be formed without contacting the fixation device. The first grip 944 and the second grip 945 facilitate holding the drill guide 930 on the bone, bones, or bone fragment, while the frictional engagement between the first template 940 and the second template 942 and the fixation device in the slots 941 and 943 maintains the body 931 on the bone, bones, or bone fragment such that the first grip 944 and the second grip 945 can be released without changing the position of the body 931 on the bone, bones, or bone fragment.
[0173] During an orthopaedic surgical procedure, the drill guide 930, via its first grip 944 and second grip 945, is positioned on the bone, bones, or bone fragments in their fusion zone with its bottom 933 adjacent to the bone, bones, or bone fragments and its first template 940 and second template 942 positioned on either side of the bone, bones, or bone fragments, so that its slots 941 and 943 receive a fixation device inserted into the bone, bones, or bone fragments. The first template 940 and second template 942 hold the body 931 on the bone, bones, or bone fragments by frictional engagement with the fixation device, and position the first passage 938 on the bone, bones, or bone fragments adjacent to a first side of the fusion zone near a first side of the fixation device and position the second passage 939 on the bone, bones, or bone fragments adjacent to a second side of the fusion zone near a second side of the fixation device. With the drill guide 930 positioned on the bone, bones, or bone fragments in this manner, drill holes formed in the bone, bones, or bone fragments are positioned on either side of the fusion zone near the fixation device. In a fifth embodiment of the drill guide 930, the first passageway 938 and the second passageway 939 are spaced apart by a distance substantially equal to the distance between the legs 187 and 188 of the implant 175 when the implant 175 is in its insertion position 177 or 207, such that any drill holes formed using the first passageway 938 and the second passageway 939 receive the legs 187 and 188 of the implant 175.
[0174] 45 shows a drill guide 950 according to a sixth embodiment used when the implant 215 according to the third embodiment is delivered to a bone, multiple bones, or bone fragments during an orthopedic surgical procedure requiring the drilling of a drill hole near a fixation device such as a fixation pin or wire (e.g., K-wire). The drill guide 950 of the fifth embodiment includes a body 951, a first template 961 and a second template 963, and a first grip 965 and a second grip 966. The drill guide 950 according to the sixth embodiment, including its body 951, first template 961 and a second template 963, and first grip 965 and a second grip 966, is substantially similar to the drill guide 900 according to the fourth embodiment, including its body 901, first template 912 and a second template 922, and first grip 914 and a second grip 924. Further, while the body 931 of the drill guide 930 includes three passages, one skilled in the art will recognize that any similar portion of the drill guide 950 incorporates the design and functionality as previously described in the detailed description of the drill guide 900 according to the fourth embodiment.
[0175] The body 951 includes a top 952, a bottom 953, a first end 954 and a second end 955, and a first side 956 and a second side 957. The body 951 further includes first, second, and third passages 958-960 extending from its top 952 to its bottom 953. The first passage 958 and the second passage 959 are located adjacent the first end 954 of the body 951, and the third passage 960 is located adjacent the second end 955 of the body 951. The first passageway 958 and the third passageway 960 are located adjacent a first side 956 of the body 951, and the second passageway 959 is located adjacent a second side 957 of the body 951, although one skilled in the art will recognize that the location of the third passageway 960 may be moved to the second side 957. Accordingly, the first, second, and third passageways 958-960 include complementary geometric configurations relative to the implant 217, and in particular to the legs 232-234 thereof, such that the first, second, and third passageways 958-960 aid in the formation of drill holes that facilitate embedding of the implant 217 into a bone, multiple bones, or bone fragments.
[0176] A first grip 965 extends from the body 951 at its first end 954. Similarly, a second grip 966 extends from the body 951 at its second end 955. The first grip 965 and second grip 966 facilitate positioning and subsequent retention of the drill guide 950 on a bone, bones, or bone fragments.
[0177] A first template 961 depends from a first grip 965 below the bottom 953 of the body 951 at a location opposite the first end 954. A second template 963 depends from a second grip 966 below the bottom 953 of the body 951 at a location opposite the second end 955. The first template 961 and the second template 963 each include a slot 962 and a slot 964 for receiving a fixation device therein that holds a bone, bones, or bone fragments during an orthopaedic surgical procedure. The slots 962 and 964 divide the first template 961 and the second template 963, respectively, such that the first passageway 958 and the third passageway 960 are located outside the slots 962 and 964 on their first sides 967 and 969, and the second passageway 959 is located outside the slots 962 and 964 on their second sides 968 and 970. Thus, when the slots 962 and 964 receive a fixation device therein, the first passageway 658 and the third passageway 660 are located near the fixation device on one side thereof, while the second passageway 659 is located near the fixation device on the opposite side thereof. Thus, the first template 961 and the second template 963, by their engagement with the fixation device via the respective slots 962 and 964, secure the body 951 on the bone, bones, or bone fragments with the first, second, and third passages 958-660 proximate the fixation device, thereby allowing drill holes to be formed without contacting the fixation device. The first and second grips 965 and 966 facilitate holding the drill guide 950 on the bone, bones, or bone fragments, while the frictional engagement between the first and second templates 961 and 963 and the fixation device at the slots 961 and 964 maintains the body 951 on the bone, bones, or bone fragments, such that the first and second grips 965 and 966 may be released without changing the position of the body 951 on the bone, bones, or bone fragments.
[0178] During an orthopaedic surgical procedure, the drill guide 950, via its first grip 965 and second grip 966, is positioned in its fusion zone on the bone, bones, or bone fragments with its bottom 953 adjacent to the bone, bones, or bone fragments and its first template 961 and second template 963 positioned on either side of the bone, bones, or bone fragments, so that its slots 962 and slots 964 receive a fixation device inserted into the bone, bones, or bone fragments. The first template 961 and the second template 963 hold the body 951 on the bone, bones, or bone fragments by frictional engagement with the fixation device, with the first passageway 958 positioned on the bone, bones, or bone fragments near the first side of the fixation device and adjacent to the first side of the fusion zone, the second passageway 659 positioned on the bone, bones, or bone fragments near the second side of the fixation device and adjacent to the first side of the fusion zone, and the third passageway 660 positioned on the bone, bones, or bone fragments near the first side of the fixation device and adjacent to the second side of the fusion zone. With the drill guide 950 positioned on the bone, bones, or bone fragments in this manner, the drill holes formed in the bone, bones, or bone fragments are positioned near the fixation device on either side of the fusion zone.
[0179] In the sixth embodiment of the drill guide 950, the first passage 658 and the second passage 659 are spaced apart a distance substantially equal to the distance between the legs 232-233 of the implant 215 when the implant 215 is in its insertion position 217 or 257, such that any drill holes formed using the first passage 658 and the second passage 659 receive the legs 232-233 of the implant 215. Similarly, the first passage 958 and the second passage 959 are spaced apart from the third passage 960 a distance substantially equal to the distance between the legs 232-233 and the legs 234 of the implant 215 when the implant 215 is in its insertion position 217 or 257, such that any drill holes formed using the first, second, and third passages 958-960 receive the legs 232-234 of the implant 215.
[0180] 46 shows an implant insertion device 60 loaded with the first embodiment implant 5 in an orthopedic fixation system, which holds the implant 5 in its insertion shape 7 or 53, so that the implant 5 is ready to be embedded in a bone, multiple bones, or bone fragments, in particular in a first bone 701 and a second bone 702, presented herein as an example. As shown in FIG. 46, the surgeon aligns the first bone 701 and the second bone 702 at the fixation zone 703 in an orientation that promotes fixation and proper healing of the first bone 701 and the second bone 702. The surgeon then drills a first hole 704 and a second hole 705 in the first bone 701 and a third hole 706 and a fourth hole 707 in the second bone 702. The first, second, third, and fourth holes 704-707 are drilled at desired spacing and locations for inserting legs 23 and 24 into the first bone 701 and legs 25 and 26 into the second bone 702, with bridge 8 spanning fusion zone 703 when implant 5 is in its insertion configuration 7 or 53. Although not required, the surgeon may create grooves in the first bone 701 and second bone 702 that facilitate more flush seating of bridge 8 of implant 5 against the first bone 701 and second bone 702. Next, the surgeon uses the implant insertion device 60 to position the tip 27 of the leg 23 of the implant 5 adjacent to the predrilled hole 704, the tip 28 of the leg 24 of the implant 5 adjacent to the predrilled hole 705, the tip 29 of the leg 25 of the implant 5 adjacent to the predrilled hole 706, and the tip 30 of the leg 26 of the implant 5 adjacent to the predrilled hole 707.
[0181] As shown in FIG. 47, the surgeon manipulates the implant insertion device 60 using its body 63, so that the legs 23-26 enter the respective pre-drilled holes 704-707. The surgeon further manipulates the implant insertion device 60 to insert the legs 23-26 into the respective pre-drilled holes 704-707 until the implant grip 64 is located on the first bone 701 and the second bone 702. More specifically, the surgeon presses the body 63, so that the tamp 79 of the body 63 presses the bridge 8 of the implant 5 through contact with the bridge 8, which in turn transmits the pushing force to the legs 23-26, so that the legs 23-26 are inserted into the respective pre-drilled holes 704-707, until the lower surface 90 of the shell 67 of the implant grip 64 abuts the first bone 710 and the second bone 702 outside the first, second, third, and fourth holes 704-707.
[0182] The surgeon continues to manipulate the implant insertion device 60, as shown in Fig. 48, to insert the legs 23-26 by the tamp 79 and the transmission of its pushing force to the legs 23-26 until the implant 5 at its bridge 8 abuts the first bone 701 and the second bone 702 across their fusion zones 703, in particular until the bridge 8 abuts the first bone 701 and the second bone 702. The surgeon simultaneously advances the implant grip 64 from its engaged position 66 to its disengaged position 65, thereby releasing the implant 5 from the implant insertion device 60. Advancement of the implant grip 64 from its engaged position 66 to its disengaged position 65 also applies a pushing force to the implant grip 64 by contact of the underside 90 of the implant grip's shell 67 with the first bone 701 and the second bone 702. Thus, the shell 67 moves along the implant grip receiver 78 of the body 63 until the shell 67 abuts at its upper surface 89 against the stop 84 adjacent the implant grip receiver 78, causing the detents 88 and 89 to disengage from the notches 92 and slide into the notches 91, respectively, thereby locking the implant grip 64 in its disengaged position 65. If desired, progression of the implant grip 64 from its engaged position 66 to its disengaged position 65 can include the surgeon pulling on the implant grip 64 while inserting the legs 23-26 into the first bone 701 and second bone 702, respectively.
[0183] The tamp 79 of the implant grip receiver 78 of the body 63 rests on the bridge 8 of the implant 5 to prevent movement of the implant 5 relative to the implant grip 64 during the progression of the implant grip 64 from its engaged position 66 to its disengaged position 65. As a result, the projections 83-86 of the inner surface 69 jump over the bridge 8 at its first end 13 and second end 14 through the recesses 13a and 14a, respectively, when the implant grip 64 moves from its engaged position 66 to its disengaged position 65, thereby releasing the opposite legs 23-26 of the segments 34, 39, 44, and 49, respectively. The projections 83-86 are inserted into the recesses 93 and 94 in the implant grip receiver 78, preventing the projections 83-86 from impeding the movement of the implant grip 64 relative to the implant grip receiver 78, until the tamp 79 finally reaches a position adjacent the lower surface 90 of the shell 67. Similarly, the retaining surfaces 79-82 located in each of the grooves 71-74 release the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively, and the grooves 71-74 of the inner surface 69 of the shell 67 are disengaged from the segments 34, 39, 44, and 49 of the legs 23-26, respectively. Furthermore, the inner surface 69 of the shell 67 is disengaged from the first and second sides 11 and 12 of the bridge 8 at their recesses 11a and 12a, causing the inner surface 69 of the shell 67 to jump over the bridge 8 of the implant 5 at its first and second sides 11 and 12 and its first and second ends 13 and 14, causing the implant 5 to exit the passage 70 of the shell 67, and as a result, the implant 5 is ejected from the implant grip 64. Insertion of the implant 5 typically involves pre-drilling first, second, third, and fourth holes 704-707, and then the surgeon can use the implant insertion device 60 to hammer the legs 23-26 into the first bone 701 and second bone 702, respectively, at the desired locations.
[0184] Once the surgeon has implanted the implant 5 into the first bone 701 and the second bone 702 with the bridge 8 spanning the fusion zone 703 using the implant insertion device 60, including moving the implant insertion device 60 to its unloaded position 61, the implant grip 64 releases the implant 5 in its disengaged position 65, and the surgeon removes the implant insertion device 60 from the implant 5, including moving the shell 67 away from the implant 5 and the tamp 79 away from over the bridge 8, as shown in FIG. 49. The implant 5, due to its superelastic or temperature dependent properties, delivers the energy stored in the transitions 15-18 and / or transitions 51, which causes the bridge 8 to move from its inserted configuration to its natural configuration, resulting in the legs 23-26 moving from their inserted positions to their natural positions, thereby applying a compressive force to the fixation zone 703 to secure the first bone 701 and the second bone 702.
[0185] Accordingly, the implant insertion device 60 improves the insertion of the implant 5 because the implant insertion device 60 does not release the constraint of the implant 5 until the legs 23-26 of the implant 5 are inserted into the first, second, third and fourth holes 704-707 of the first bone 701 and the second bone 702, respectively, and the bridge 8 of the implant 5 is fully seated flush on the first bone 701 and the second bone 702. Thus, an extra tamping step that may not be practical or feasible and may cause damage to the implant 5 or may cause breakage in the first bone 701 and the second bone 702 is eliminated by the implant insertion device 60. Furthermore, the implant 5 is prevented by the implant insertion device 60 from prematurely delivering the energy stored therein to the first bone 701 and the second bone 702 at its fixation zone 703.
[0186] When using the implant insertion device 100 to implant an implant 5 into a first bone 701 and a second bone 702, one skilled in the art will recognize that the implant insertion device 100 operates in a substantially similar manner to implanting an implant 5 using the implant insertion device 60 as described above, except that the implant grip 104 of the implant insertion device 100, including an actuator 109 and a first blade 107 and a second blade 108 that contact the first bone 701 and the second bone 702, facilitates delivery of the implant 5 to the first bone 701 and the second bone 702. Alternatively, when using implant insertion device 208 to implant implant 175 or implant insertion device 400 to implant implant 215, those skilled in the art will recognize that implant insertion device 208 or 400 operate in a substantially similar manner with respect to implanting implant 5 using implant insertion device 60 as described above, except that the number of pre-drilled holes corresponds to the location, spacing, and number based on the configuration and number of legs of implants 175 and 215. Further, when using the implant insertion device 300 to implant the implant 175 or the implant insertion device 500 to implant the implant 215, those skilled in the art will recognize that the implant insertion devices 300 and 500 operate substantially similarly to implanting the implant 5 using the implant insertion device 60 as described above, except that the implant grips 304 and 504 of the implant insertion devices 300 and 500, including the actuator 109 and the first blade 107 and the second blade 108 that contact the first bone 701 and the second bone 702, facilitate delivery of the implant 175 or 215 to the first bone 701 and the second bone 702, and the multiple pre-drilled holes correspond in position, spacing, and number based on the configuration and number of the legs of the implants 175 and 215.
[0187] 50A-54 illustrate the use of drill guide 600 according to a first embodiment in combination with an orthopedic fixation system, presented herein by way of example, for implanting an implant into a bone, multiple bones, or bone fragments, specifically into a first bone 801 and a second bone 802. Although FIGS. 50A-54 illustrate drill guide 600 used with an implant insertion device 60 that holds implant 5 in its insertion configuration 7 or 53, those skilled in the art will recognize that drill guide 600 may be used with any tetrapod type implant and alternative techniques or implant insertion devices.
[0188] As shown in FIGS. 50A-50B, the surgeon aligns the first bone 801 and the second bone 802 at the fixation zone 803 in an orientation that promotes fixation and proper healing of the first bone 801 and the second bone 802. After aligning the first bone 801 and the second bone 802 at their fusion zone 803, the surgeon introduces a fixation device into the first bone 801 and the second bone 802. Illustratively, the surgeon inserts a K-wire 810 through the first bone 801 and into the second bone 802, such that the K-wire 810 spans the fixation zone 803 to fix the first bone 801 and the second bone 802 in an orientation that promotes proper healing thereof. The surgeon then places a drill guide 600 across the fixation zone 803 and on the first bone 801 and the second bone 802. More specifically, the surgeon uses the grip 614 of the drill guide 600 to position the body 601 of the drill guide 600 across the fusion zone 803, over the first and second bones 801 and 802, with its bottom 603 abutting the first and second bones 801 and 802, and inserts the template 612 of the drill guide 600 into the fusion zone 803 between the first bone 801 and the second bone 802, such that the slot 613 of the template 612 receives the K-wire 810 therein. The template 612, via its insertion into the fixation zone 803 and engagement with the K-wire 810, fixes the body 601 of the drill guide 600 onto the first bone 801 and the second bone 802, and positions the third passage 610 of the body 601 on the first bone 801 adjacent the first side 804 of the fusion zone 803 near the first side 811 of the K-wire 810 and adjacent the second side 812 of the K-wire 810. A fourth passage 611 is positioned on the first bone 801 adjacent to the first side 804 of the fusion zone 803, a first passage 608 is positioned on the second bone 802 adjacent to the second side 805 of the fusion zone 803 near the first side 811 of the K-wire 810, and a second passage 609 is positioned on the second bone 802 adjacent to the second side 805 of the fusion zone 803 near the second side 812 of the K-wire 810.
[0189] With the body 601 of the drill guide 600 thus positioned on the first bone 801 and the second bone 802, including the template 612 of the drill guide 600 inserted between the first bone 801 and the second bone 802 and engaged with the K-wire 810, the surgeon drills a first hole 806 in the first bone 801 adjacent the first side 804 of the fusion zone 803 near the first side 811 of the K-wire 810, and inserts the K-wire 810 into the first bone 801. A second hole 807 is drilled in the first bone 801 adjacent the first side 804 of the fusion zone 803 near the second side 812 of the K-wire 810, a third hole 808 is drilled in the second bone 802 adjacent the second side 805 of the fusion zone 803 near the first side 811 of the K-wire 810, and a fourth hole 809 is drilled in the second bone 802 adjacent the second side 805 of the fusion zone 803 near the second side 812 of the K-wire 810. Thus, the drill guide 600 facilitates drilling the first, second, third, and fourth drill holes 806-809 proximate the K-wire 810 while preventing a drill bit of a drill used in forming the first, second, third, and fourth drill holes 806-809 from impinging on the K-wire 810. Insertion of the template 613 into the fusion zone 803 separates the first bone 801 from the second bone 802, but the first bone 801 is held aligned with the second bone 802 in an orientation that promotes fixation and proper healing by insertion of K-wires 810 into the first bone 801 and second bone 802 across the fusion zone 803 and engagement with the template 613 via slots 613.
[0190] After drilling the first, second, third, and fourth drill holes 806-809, the surgeon removes the drill guide 600 from the first bone 801 and the second bone 802, as shown in FIG 51, thereby disengaging the template 612 from the K-wire 810 and out of the fusion zone 803. The surgeon then compresses the first bone 801 and the second bone 802 until they abut against their fusion zones 803. Since the distance between the first passage 608 and the third passage 610 and the second passage 609 and the fourth passage 611 in the first embodiment of the drill guide 600 is substantially equal to the distance between the legs 23 and 25 or the legs 24 and 26 of the implant 5 when the implant 5 is in its insertion position 7 or 53, plus a distance equal to the thickness 617 of the template 612, the compression of the first bone 801 and the second bone 802 is substantially equal to the distance between the first hole 806 and the third hole 808 and the second hole 609. The distance between the first hole 806 and the third hole 808, and the second hole 807 and the fourth hole 809 is reduced relative to the distance between the first passage 608 and the third passage 610 and the second passage 609 and the fourth passage 611, but the reduction in distance does not affect the ability of the first hole 806 and the third hole 808, and the second hole 807 and the fourth hole 809 to receive the legs 23 and 25 or the legs 24 and 26 of the implant 5 therein, respectively, when the implant 5 is in its insertion position 7 or 53.
[0191] After making any necessary reorientations of the first bone 801 and the second bone 802, the surgeon is ready to use the implant insertion device 60 to implant the implant 5 in its insertion configuration 7 or 53 into the first bone 801 and the second bone 802. As previously described, the first, second, third, and fourth holes 806-809 are located in the first bone 801 and the second bone 802, respectively, at desired spacing and locations for inserting legs 23 and 24 into the first bone 801 and legs 25 and 26 into the second bone 802, with the bridge 8 spanning the fusion zone 803 when the implant 5 is in its insertion configuration 7 or 53. Although not required, the surgeon may create grooves in the first bone 801 and the second bone 802 that facilitate a more flush seating of the bridge 8 of the implant 5 against the first bone 801 and the second bone 802. Next, the surgeon uses the implant insertion device 60 to position the tip 27 of the leg 23 of the implant 5 adjacent to the predrilled hole 806, the tip 28 of the leg 24 of the implant 5 adjacent to the predrilled hole 807, the tip 29 of the leg 25 of the implant 5 adjacent to the predrilled hole 808, and the tip 30 of the leg 26 of the implant 5 adjacent to the predrilled hole 809.
[0192] As shown in FIG. 52, the surgeon manipulates the implant insertion device 60 using its body 63, so that the legs 23-26 enter the respective pre-drilled holes 806-809. The surgeon further manipulates the implant insertion device 60 to insert the legs 23-26 into the respective pre-drilled holes 806-809 until the implant grip 64 is located on the first bone 801 and the second bone 802. More specifically, the surgeon presses the body 63, so that the tamp 79 of the body 63 presses the bridge 8 of the implant 5 through contact with the bridge 8, which in turn transmits the pushing force to the legs 23-26, so that the legs 23-26 are inserted into the respective pre-drilled holes 806-809, until the lower surface 90 of the shell 67 of the implant grip 64 abuts against the first bone 801 and the second bone 802 outside the first, second, third, and fourth holes 806-809.
[0193] The surgeon continues to manipulate the implant insertion device 60, as shown in Fig. 53, to insert the legs 23-26 by the tamp 79 and the transmission of its pushing force to the legs 23-26 until the implant 5 at its bridge 8 abuts the first bone 801 and the second bone 802 across their fusion zones 803, in particular until the bridge 8 abuts the first bone 801 and the second bone 802. The surgeon simultaneously advances the implant grip 64 from its engaged position 66 to its disengaged position 65, thereby releasing the implant 5 from the implant insertion device 60. Advancement of the implant grip 64 from its engaged position 66 to its disengaged position 65 also applies a pushing force to the implant grip 64 by contact of the underside 90 of the implant grip's shell 67 with the first bone 801 and the second bone 802. Thus, the shell 67 moves along the implant grip receiver 78 of the body 63 until the shell 67 abuts at its upper surface 89 against the stop 84 adjacent the implant grip receiver 78, causing the detents 88 and 89 to disengage from the notches 92 and slide into the notches 91, respectively, thereby locking the implant grip 64 in its disengaged position 65. If desired, progression of the implant grip 64 from its engaged position 66 to its disengaged position 65 can include the surgeon pulling on the implant grip 64 while inserting the legs 23-26 into the first bone 801 and second bone 802, respectively.
[0194] The tamps 79 of the implant grip receiver 78 of the body 63 rest on the bridge 8 of the implant 5, thereby preventing movement of the implant 5 relative to the implant grip 64 as the implant grip 64 progresses from its engaged position 66 to its disengaged position 65. As a result, the projections 83-86 of the inner surface 69 jump over the bridge 8 at its first end 13 and second end 14 via the recesses 13a and 14a, respectively, as the implant grip 64 moves from its engaged position 66 to its disengaged position 65, thereby releasing the opposite legs 23-26 of the segments 34, 39, 44, and 49, respectively. The projections 83-86 are inserted into the recesses 93 and 94 in the implant grip receiver 78, preventing the projections 83-86 from impeding movement of the implant grip 64 relative to the implant grip receiver 78, until the tamps 79 finally reach a position adjacent the underside 90 of the shell 67. Similarly, the retaining surfaces 79-82 located in each of the grooves 71-74 release the engagement points 35, 40, 44, and 50 of the legs 23-26, respectively, and the grooves 71-74 of the inner surface 69 of the shell 67 are disengaged from the segments 34, 39, 44, and 49 of the legs 23-26, respectively. Furthermore, the inner surface 69 of the shell 67 is disengaged from the first and second sides 11 and 12 of the bridge 8 at their recesses 11a and 12a, causing the inner surface 69 of the shell 67 to jump over the bridge 8 of the implant 5 at its first and second sides 11 and 12 and its first and second ends 13 and 14, causing the implant 5 to exit the passage 70 of the shell 67, and as a result, the implant 5 is ejected from the implant grip 64.
[0195] Once the surgeon has implanted the implant 5 into the first bone 801 and the second bone 802 with the bridge 8 spanning the fusion zone 803 using the implant insertion device 60, including moving the implant insertion device 60 to its unloaded position 61, the implant grip 64 releases the implant 5 in its disengaged position 65, and the surgeon removes the implant insertion device 60 from the implant 5, including moving the shell 67 away from the implant 5 and the tamp 79 away from over the bridge 8, as shown in FIG. 54. The implant 5, due to its superelastic or temperature dependent properties, delivers the energy stored in the transitions 15-18 and / or transitions 51, which causes the bridge 8 to transition from its inserted configuration to its natural configuration, resulting in the legs 23-26 moving from their inserted positions to their natural positions, causing the implant 5 to apply a compressive force to the fixation zone 803 to attach the first bone 801 and the second bone 802. Finally, the surgeon removes the K-wires 810 from the first bone 801 and the second bone 802, if desired.
[0196] When an orthopaedic surgical procedure incorporating drill guide 630 is used to implant a bipod implant, such as implant 175, or when an orthopaedic surgical procedure incorporating drill guide 650 is used to implant a tripod implant, such as implant 215, a person skilled in the art will recognize that the orthopaedic surgical procedure incorporating drill guides 630 and 650 will be substantially similar to the orthopaedic surgical procedure incorporating drill guide 600 described above, except that the number of pre-drilled holes will correspond in location, spacing, and number based on the configuration of drill guides 630 and 650.
[0197] 55A-59 illustrate the use of drill guide 900 according to a fourth embodiment in combination with an orthopedic fixation system, presented herein by way of example, for implanting an implant into a bone, multiple bones, or bone fragments, specifically into a first bone 851 and a second bone 852. Although FIGS. 55A-59 illustrate drill guide 900 used with an implant insertion device 60 that holds an implant 5 in its insertion configuration 7 or 53, those skilled in the art will recognize that drill guide 900 may be used with any tetrapod type implant and alternative techniques or implant insertion devices.
[0198] As shown in FIGS. 55A-55B, the surgeon aligns the first bone 851 and the second bone 852 at the fixation zone 853 in an orientation that promotes fixation and proper healing of the first bone 851 and the second bone 852. After aligning the first bone 851 and the second bone 852 at their fusion zone 853, the surgeon introduces a fixation device into the first bone 851 and the second bone 852. Illustratively, the surgeon inserts a K-wire 860 through the first bone 851 and the second bone 852, such that the K-wire 860 spans the fixation zone 853 to fix the first bone 851 and the second bone 852 in an orientation that promotes proper healing thereof. The surgeon then places a drill guide 900 across the fixation zone 853 and on the first bone 851 and the second bone 852. More specifically, the surgeon uses the first grip 914 and / or the second grip 924 of the drill guide 900 to position the body 901 of the drill guide 900 over the first bone 851 and the second bone 852 across the fusion zone 853 with the bottom 903 abutting the first bone 851 and the second bone 852. The surgeon further positions the first template 912 of the drill guide 900 adjacent the first bone 851 such that its slot 913 receives the K-wire 860 extending from the first bone 851, and positions the second template 922 of the drill guide 900 adjacent the second bone 852 such that its slot 923 receives the K-wire 860 extending from the second bone 851.The first template 912 and the second template 922, by their respective placement adjacent the first bone 851 and the second bone 852 and engagement with the K-wire 860, secure the body 901 of the drill guide 900 on the first bone 851 and the second bone 852, and secure the first passage 908 of the body 901 on the first bone 851 adjacent the first side 861 of the K-wire 860 and adjacent the first side 854 of the fusion zone 853 near the first side 861 of the K-wire 860, and the first passage 908 of the body 901 on the first bone 851 adjacent the first side 854 of the fusion zone 853 near the first side 861 of the K-wire 860. A second passage 909 is positioned on the first bone 851 adjacent to the first side 854 of the fusion zone 853 near the second side 862 of the wire 860, a third passage 910 is positioned on the second bone 852 adjacent to the second side 855 of the fusion zone 853 near the first side 861 of the K-wire 860, and a fourth passage 911 is positioned on the second bone 852 adjacent to the second side 855 of the fusion zone 853 near the second side 862 of the K-wire 860.
[0199] With the body 901 of the drill guide 900 thus positioned on the first bone 851 and the second bone 852, including the first template 912 and the second template 922 of the drill guide 900 positioned adjacent the first bone 851 and the second bone 852, respectively, and engaged with the K-wire 860, the surgeon may then perform a first drill on the first bone 851 adjacent the first side 861 of the K-wire 860 and adjacent the first side 854 of the fusion zone 853. A first hole 856 is drilled in the first bone 851 adjacent to the first side 854 of the fusion zone 853 near the second side 862 of the K-wire 860, a second hole 857 is drilled in the second bone 852 adjacent to the first side 855 of the fusion zone 853 near the first side 861 of the K-wire 860, and a fourth hole 859 is drilled in the second bone 852 adjacent to the second side 855 of the fusion zone 853 near the second side 862 of the K-wire 860. Thus, the drill guide 900 facilitates drilling the first, second, third, and fourth drill holes 856-859 in proximity to the K-wire 860 while preventing a drill bit of a drill used in forming the first, second, third, and fourth drill holes 866-859 from impinging on the K-wire 860. After drilling the first, second, third, and fourth drill holes 856-859, the surgeon removes the drill guide 900 from the first bone 851 and the second bone 852, as shown in FIG. 56, thereby disengaging the first template 912 and the second template 922 from the K-wire 860.
[0200] After any necessary reorientation of the first bone 851 and the second bone 852 has been performed, the implant 5 in its insertion configuration 7 or 53 is ready for the surgeon to use the implant insertion device 60 to implant the implant 5 into the first bone 851 and the second bone 852. As previously described, based on the location of the first, second, third and fourth passages 908-911 in the body 901, the first, second, third and fourth holes 856-859 are located in the first bone 851 and the second bone 852, respectively, at the desired spacing and location for inserting legs 23 and 24 into the first bone 851 and legs 25 and 26 into the second bone 852, with the bridge 8 spanning the fusion zone 853 when the implant 5 is in its insertion configuration 7 or 53. Although not required, the surgeon may create grooves in the first bone 851 and the second bone 852 that facilitate more flush seating of the bridge 8 of the implant 5 against the first bone 851 and the second bone 852. The surgeon then utilizes the implant insertion device 60 to position the tip 27 of the leg 23 of the implant 5 adjacent to the pre-drilled hole 856, the tip 28 of the leg 24 of the implant 5 adjacent to the pre-drilled hole 857, the tip 29 of the leg 25 of the implant 5 adjacent to the pre-drilled hole 858, and the tip 30 of the leg 26 of the implant 5 adjacent to the pre-drilled hole 859.
[0201] As shown in FIG. 57, the surgeon manipulates the implant insertion device 60 using its body 63, so that the legs 23-26 enter the respective pre-drilled holes 856-859. The surgeon further manipulates the implant insertion device 60 to insert the legs 23-26 into the respective pre-drilled holes 856-859 until the implant grip 64 is located on the first bone 851 and the second bone 852. More specifically, the surgeon presses the body 63, so that the tamp 79 of the body 63 presses the bridge 8 of the implant 5 through contact with the bridge 8, which in turn transmits the pushing force to the legs 23-26, so that the legs 23-26 are inserted into the respective pre-drilled holes 856-859, until the lower surface 90 of the shell 67 of the implant grip 64 abuts against the first bone 851 and the second bone 852 outside the first, second,...
Claims
1. 1. An orthopedic fixation system comprising:
1. An implant capable of transitioning between a natural configuration and an insertion configuration, comprising: Bridge, a first anchoring member extending from the bridge, the first anchoring member including a segment extending outwardly of the bridge to provide an engagement point; a second anchoring member extending from the bridge, the second anchoring member including a segment extending outside of the bridge to provide an engagement point; an implant insertion device movable between a loaded position in which the implant insertion device jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby constraining the implant in its inserted configuration, and an unloaded position in which the implant insertion device releases the implant; the bridge includes first and second sides and first and second ends; the first anchoring member extends from the bridge at the first end of the bridge adjacent the first side of the bridge, the first anchoring member having a side-to-side width such that the segment of the first anchoring member extends outside of the bridge on its first side to provide the engagement point; the second anchoring member extends from the bridge at the second end of the bridge adjacent the first side of the bridge, the second anchoring member having a side-to-side width such that the segment of the second anchoring member extends exterior to the bridge on its first side to provide the engagement point; a third anchoring member extends from the bridge at the first end of the bridge adjacent the second side of the bridge, the third anchoring member having a side-to-side width such that a segment of the third anchoring member extends exterior to the bridge on its second side to provide an engagement point; a fourth anchoring member extends from the bridge at the second end of the bridge adjacent the second side of the bridge, the fourth anchoring member having a side-to-side width such that a segment of the fourth anchoring member extends exterior to the bridge on its second side to provide an engagement point; The implant insertion device comprises: a body including a first end and a second end; an implant grip coupled to the body at a second end thereof, the implant grip movable relative to the body between an engaged position in which the implant grip jumps over the bridge and engages the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at their engagement points, thereby restraining the implant in its insertion configuration, and a disengaged position in which the implant grip releases the implant; the implant grip comprises a shell; the shell includes an exterior surface having an upper surface and a lower surface; the shell includes an inner surface having a shape complementary to the implant, the inner surface defining a passageway through the shell having a shape complementary to the implant; said shell is coupled to said body by receiving said body at its second end in said passageway on said upper surface of said shell; an implant receiving portion configured to receive the implant into the passageway at a lower surface of the shell, the implant then overshooting the bridge at an inner surface of the shell and engaging the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at their engagement points, thereby retaining the implant within the shell and restraining the implant in its insertion configuration.
2. 2. The orthopedic fixation system of claim 1, wherein the inner surface of the shell defines first, second, third, and fourth grooves whereby each of the first, second, third, and fourth grooves receives one of the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member therein as the shell leaps over the bridge at its inner surface, and further whereby the inner surface engages the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at the first, second, third, and fourth grooves, thereby retaining the implant within the shell in its inserted configuration.
3. 3. The orthopedic fixation system of claim 2, wherein the inner surface defines a retaining surface in each of the first, second, third, and fourth grooves such that when the first, second, third, and fourth grooves receive one of the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member therein, each of the retaining surfaces abuts one of the engagement points of the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member, whereby the retaining surfaces grip and restrain the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member such that the shell retains the implant therein in its insertion configuration.
4. 3. The orthopedic fixation system of claim 2, wherein the inner surface of the shell includes a protrusion such that when the shell at its inner surface jumps over the bridge, the protrusion jumps over the bridge and engages one of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member, thereby holding the implant therein in its insertion configuration.
5. 5. The orthopedic fixation system of claim 4, wherein the projection is resilient such that when the shell jumps over the bridge on its inner surface, the projection moves relative to the bridge to jump over the bridge and engage one of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member, thereby holding the implant in its insertion configuration therein.
6. 2. The orthopedic fixation system of claim 1, wherein the body comprises an implant grip receiver at the second end of the body, the implant grip receiver terminating in a tamp, the implant grip receiver being complementary in shape to the inner surface of the shell, and further wherein the implant grip receiver is inserted into the passage of the shell at the upper surface of the shell, thereby coupling the implant grip receiver to the shell.
7. 7. The orthopedic fixation system of claim 6, wherein when the implant grip is in its engaged position, the tamp sits on the bridge of the implant, and further wherein the tamp remains on the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
8. the implant grip receiving portion includes a first notch and a second notch; 7. The orthopedic fixation system of claim 6, wherein the inner surface of the shell includes a detent engageable with the first notch and the second notch, whereby when the implant grip moves to its engaged position, the detent engages with the first notch to lock the implant grip in its engaged position, and further whereby when the implant grip moves to its disengaged position, the detent engages with the second notch to lock the implant grip in its disengaged position.
9. An orthopedic fixation system comprising:
1. An implant capable of transitioning between a natural configuration and an insertion configuration, comprising: Bridge, a first anchoring member extending from the bridge, the first anchoring member including a segment extending outwardly of the bridge to provide an engagement point; a second anchoring member extending from the bridge, the second anchoring member including a segment extending outside of the bridge to provide an engagement point; an implant insertion device movable between a loaded position in which the implant insertion device jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby constraining the implant in its inserted configuration, and an unloaded position in which the implant insertion device releases the implant; the bridge includes first and second sides and first and second ends; the first anchoring member extends from the bridge at the first end of the bridge adjacent the first side of the bridge, the first anchoring member having a side-to-side width such that the segment of the first anchoring member extends outside of the bridge on its first side to provide the engagement point; the second anchoring member extends from the bridge at the second end of the bridge adjacent the first side of the bridge, the second anchoring member having a side-to-side width such that the segment of the second anchoring member extends exterior to the bridge on its first side to provide the engagement point; a third anchoring member extends from the bridge at the first end of the bridge adjacent the second side of the bridge, the third anchoring member having a side-to-side width such that a segment of the third anchoring member extends exterior to the bridge on its second side to provide an engagement point; a fourth anchoring member extends from the bridge at the second end of the bridge adjacent the second side of the bridge, the fourth anchoring member having a side-to-side width such that a segment of the fourth anchoring member extends exterior to the bridge on its second side to provide an engagement point; The implant insertion device comprises: a body including a first end and a second end; an implant grip coupled to the body at a second end thereof, the implant grip movable relative to the body between an engaged position in which the implant grip jumps over the bridge and engages the segments of the first anchoring member, the second anchoring member, the third anchoring member, and the fourth anchoring member at their engagement points, thereby restraining the implant in its insertion configuration, and a disengaged position in which the implant grip releases the implant; The implant grip comprises: an actuator coupled to the body and movable relative to the body, movement of the actuator advancing the implant grip between its engaged and disengaged positions; and a first blade and a second blade securable to the actuator in opposing relationship and defining a passage therebetween, the passage receiving the bridge of the implant therein, and the first blade and the second blade extending beyond the bridge to engage the segments of the first anchor member, the second anchor member, the third anchor member, and the fourth anchor member at their engagement points to retain the implant and restrain the implant in its insertion configuration; The actuator, a first slider that is securable to the first blade; a second slider securable to the second blade; a spacer securable between the first slider and the second slider to space the first blade and the second blade to form the passage therebetween.
10. The body comprises: a tamp at the second end thereof; 10. The orthopedic fixation system of claim 9, further comprising: a slot communicating with an exterior of the body, the slot receiving the spacer therein; the first slider secured to the spacer adjacent a first surface of the body whereby the first blade extends beyond the tamp; and the second slider secured to the spacer adjacent a second surface of the body whereby the second blade extends beyond the tamp, such that the passage between the first blade and the second blade is located adjacent the tamp.
11. 11. The orthopedic fixation system of claim 10, wherein when the implant grip is in its engaged position, the tamp sits on the bridge of the implant, and further wherein the tamp remains on the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
12. An orthopedic fixation system comprising:
1. An implant capable of transitioning between a natural configuration and an insertion configuration, comprising: Bridge, a first anchoring member extending from the bridge, the first anchoring member including a segment extending outwardly of the bridge to provide an engagement point; a second anchoring member extending from the bridge, the second anchoring member including a segment extending outside of the bridge to provide an engagement point; an implant insertion device movable between a loaded position in which the implant insertion device jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby constraining the implant in its inserted configuration, and an unloaded position in which the implant insertion device releases the implant; the bridge includes first and second sides and first and second ends; said first anchoring member extends from said bridge at said first end of said bridge, said first anchoring member including a width between its sides, whereby said segment of said first anchoring member is a first segment and said engagement point is a first engagement point, such that said first segment extends exterior to said bridge at a first side of said bridge to provide said first engagement point, and further whereby said first anchoring member includes a second segment extending exterior to said bridge at a second side of said bridge to provide a second engagement point; the second anchoring member extends from the bridge at the second end of the bridge, the second anchoring member including a width between its sides, whereby the segment of the second anchoring member is a first segment and the engagement point is a first engagement point, such that the first segment extends exterior to the bridge at a first side of the bridge to provide the first engagement point, and further whereby the second anchoring member includes a second segment extending exterior to the bridge at a second side of the bridge to provide a second engagement point; The implant insertion device comprises: a body including a first end and a second end; an implant grip coupled to the body at a second end thereof, the implant grip being movable relative to the body between an engaged position in which the implant grip jumps over the bridge to engage the first and second segments of the first anchoring member at their first and second engagement points and to engage the first and second segments of the second anchoring member at their first and second engagement points, thereby restraining the implant in its insertion configuration, and a disengaged position in which the implant grip releases the implant; The implant grip comprises a shell; the shell includes an exterior surface having an upper surface and a lower surface; the shell includes an inner surface having a shape complementary to the implant, the inner surface defining a passageway through the shell having a shape complementary to the implant; said shell is coupled to said body by receiving said body at its second end in said passageway on said upper surface of said shell; an implant receiving portion for receiving the implant from the passageway at a lower surface of the shell, the implant then overhanging the bridge at an inner surface of the shell and engaging the first and second segments of the first anchoring member at their first and second engagement points, and engaging the first and second segments of the second anchoring member at their first and second engagement points, thereby retaining the implant within the shell and constraining the implant in its insertion configuration.
13. 13. The orthopedic fixation system of claim 12, wherein the inner surface of the shell defines first, second, third, and fourth grooves whereby each of the first, second, third, and fourth grooves receives one of the first and second segments of the first and second anchoring members therein as the shell leaps over the bridge at its inner surface, and further whereby the inner surface engages the first and second anchoring members at the first, second, third, and fourth grooves, thereby retaining the implant within the shell in its inserted configuration.
14. 14. The orthopedic fixation system of claim 13, wherein the inner surface defines a retaining surface in each of the first, second, third, and fourth grooves such that when the first, second, third, and fourth grooves receive one of the first and second segments of the first and second anchoring members therein, each of the retaining surfaces abuts one of the first and second engagement points of the first and second segments of the first and second anchoring members, whereby the retaining surfaces grip and restrain the first and second anchoring members such that the shell retains the implant therein in its insertion configuration.
15. 13. The orthopedic fixation system of claim 12, wherein the body comprises an implant grip receiver at the second end of the body, the implant grip receiver terminating in a tamp, the implant grip receiver being complementary in shape to the inner surface of the shell, and further wherein the implant grip receiver is inserted into the passage of the shell at the top surface of the shell, thereby coupling the implant grip receiver to the shell.
16. 16. The orthopedic fixation system of claim 15, wherein when the implant grip is in its engaged position, the tamp sits on the bridge of the implant, and further wherein the tamp remains on the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
17. the implant grip receiving portion includes a first notch and a second notch; 16. The orthopedic fixation system of claim 15, wherein the inner surface of the shell includes a detent engageable with the first notch and the second notch, whereby when the implant grip moves to its engaged position, the detent engages with the first notch to lock the implant grip in its engaged position, and further whereby when the implant grip moves to its disengaged position, the detent engages with the second notch to lock the implant grip in its disengaged position.
18. An orthopedic fixation system comprising:
1. An implant capable of transitioning between a natural configuration and an insertion configuration, comprising: Bridge, a first anchoring member extending from the bridge, the first anchoring member including a segment extending outwardly of the bridge to provide an engagement point; a second anchoring member extending from the bridge, the second anchoring member including a segment extending outside of the bridge to provide an engagement point; an implant insertion device movable between a loaded position in which the implant insertion device jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby constraining the implant in its inserted configuration, and an unloaded position in which the implant insertion device releases the implant; the bridge includes first and second sides and first and second ends; said first anchoring member extends from said bridge at said first end of said bridge, said first anchoring member including a width between its sides, whereby said segment of said first anchoring member is a first segment and said engagement point is a first engagement point, such that said first segment extends exterior to said bridge at a first side of said bridge to provide said first engagement point, and further whereby said first anchoring member includes a second segment extending exterior to said bridge at a second side of said bridge to provide a second engagement point; the second anchoring member extends from the bridge at the second end of the bridge, the second anchoring member including a width between its sides, whereby the segment of the second anchoring member is a first segment and the engagement point is a first engagement point, such that the first segment extends exterior to the bridge at a first side of the bridge to provide the first engagement point, and further whereby the second anchoring member includes a second segment extending exterior to the bridge at a second side of the bridge to provide a second engagement point; The implant insertion device comprises: a body including a first end and a second end; an implant grip coupled to the body at a second end thereof, the implant grip being movable relative to the body between an engaged position in which the implant grip jumps over the bridge to engage the first and second segments of the first anchoring member at their first and second engagement points and to engage the first and second segments of the second anchoring member at their first and second engagement points, thereby restraining the implant in its insertion configuration, and a disengaged position in which the implant grip releases the implant; The implant grip comprises: an actuator coupled to the body and movable relative to the body, movement of the actuator advancing the implant grip between its engaged and disengaged positions; and a first blade and a second blade securable to the actuator in opposing relationship and defining a passage therebetween, the passage receiving the bridge of the implant therein and the first and second blades extending beyond the bridge to engage the first and second segments of the first and second anchoring members at their first and second engagement points to retain the implant and constrain the implant in its insertion configuration; The actuator, a first slider that is securable to the first blade; a second slider securable to the second blade; a spacer securable between the first slider and the second slider to space the first blade and the second blade to form the passage therebetween.
19. The body comprises: a tamp at the second end thereof; 20. The orthopedic fixation system of claim 18, further comprising: a slot communicating with an exterior of the body, the slot receiving the spacer therein; the first slider secured to the spacer adjacent a first surface of the body whereby the first blade extends beyond the tamp; and the second slider secured to the spacer adjacent a second surface of the body whereby the second blade extends beyond the tamp, such that the passage between the first blade and the second blade is located adjacent the tamp.
20. 20. The orthopedic fixation system of claim 19, wherein when the implant grip is in its engaged position, the tamp sits on the bridge of the implant, and further wherein the tamp remains on the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
21. An orthopedic fixation system comprising:
1. An implant capable of transitioning between a natural configuration and an insertion configuration, comprising: Bridge, a first anchoring member extending from the bridge, the first anchoring member including a segment extending outwardly of the bridge to provide an engagement point; a second anchoring member extending from the bridge, the second anchoring member including a segment extending outside of the bridge to provide an engagement point; an implant insertion device movable between a loaded position in which the implant insertion device jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby constraining the implant in its inserted configuration, and an unloaded position in which the implant insertion device releases the implant; the bridge includes first and second sides and first and second ends; the first anchoring member extends from the bridge at the first end of the bridge adjacent the first side of the bridge, the first anchoring member having a side-to-side width such that the segment of the first anchoring member extends outside of the bridge on its first side to provide the engagement point; the second anchoring member extends from the bridge at the second end of the bridge, the second anchoring member including a width between its sides, whereby the segment of the second anchoring member is a first segment and the engagement point is a first engagement point, such that the first segment extends exterior to the bridge at a first side of the bridge to provide the first engagement point, and further whereby the second anchoring member includes a second segment extending exterior to the bridge at a second side of the bridge to provide a second engagement point; a third tether member extends from the bridge at the first end of the bridge adjacent the second side of the bridge, the third tether member having a side-to-side width such that a segment of the third tether member extends exteriorly of the bridge at the second side of the bridge to provide an engagement point; The implant insertion device comprises: a body including a first end and a second end; an implant grip coupled to the body at a second end thereof, the implant grip movable relative to the body between an engaged position in which the implant grip jumps over the bridge to engage the segments of the first and third anchoring members at their engagement points and engage the first and second segments of the second anchoring member at their first and second engagement points, thereby restraining the implant in its insertion configuration, and a disengaged position in which the implant grip releases the implant; the implant grip comprises a shell; the shell includes an exterior surface having an upper surface and a lower surface; the shell includes an inner surface having a shape complementary to the implant, the inner surface defining a passageway through the shell having a shape complementary to the implant; said shell is coupled to said body by receiving said body at its second end in said passageway on said upper surface of said shell; an implant receiving portion for receiving the implant from the passageway at a lower surface of the shell, whereby the shell overhangs the bridge at an inner surface of the shell to engage the segments of the first and third anchor members at their engagement points and engage the first and second segments of the second anchor member at their first and second engagement points, thereby retaining the implant within the shell and constraining the implant in its insertion configuration.
22. 22. The orthopedic fixation system of claim 21, wherein the inner surface of the shell defines first, second, third, and fourth grooves whereby each of the first, second, third, and fourth grooves receives one of the segments of the first and third anchoring members and the first and second segments of the second anchoring member when the shell leaps over the bridge at its inner surface, whereby the inner surface engages the first, second, and third anchoring members at the first, second, third, and fourth grooves, thereby retaining the implant in its inserted configuration within the shell.
23. 23. The orthopedic fixation system of claim 22, wherein the inner surface defines a retaining surface in each of the first, second, third, and fourth grooves such that when the first, second, third, and fourth grooves receive one of the segments of the first and third anchoring members and the first and second segments of the second anchoring member therein, each of the retaining surfaces abuts one of the engagement points of the segments of the first and third anchoring members and the first and second engagement points of the first and second segments of the second anchoring member, whereby the retaining surfaces grip and restrain the first, second, and third anchoring members such that the shell retains the implant therein in its inserted configuration.
24. 23. The orthopedic fixation system of claim 22, wherein the inner surface of the shell includes a protrusion such that when the shell at its inner surface jumps over the bridge, the protrusion jumps over the bridge and engages one of the first and third anchoring members, thereby holding the implant therein in its insertion configuration.
25. 25. The orthopedic fixation system of claim 24, wherein the projection is resilient such that when the shell jumps over the bridge on its inner surface, the projection moves relative to the bridge to jump over the bridge and engage one of the first and third anchoring members, thereby holding the implant therein in its insertion configuration.
26. 22. The orthopedic fixation system of claim 21, wherein the body comprises an implant grip receiver at the second end of the body, the implant grip receiver terminating in a tamp, the implant grip receiver being complementary in shape to the inner surface of the shell, and further wherein the implant grip receiver is inserted into the passage of the shell at the top surface of the shell, thereby coupling the implant grip receiver to the shell.
27. 27. The orthopedic fixation system of claim 26, wherein when the implant grip is in its engaged position, the tamp sits on the bridge of the implant, and further, the tamp remains on the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
28. the implant grip receiving portion includes a first notch and a second notch; 27. The orthopedic fixation system of claim 26, wherein the inner surface of the shell includes a detent engageable with the first notch and the second notch, whereby when the implant grip moves to its engaged position, the detent engages with the first notch to lock the implant grip in its engaged position, and further whereby when the implant grip moves to its disengaged position, the detent engages with the second notch to lock the implant grip in its disengaged position.
29. An orthopedic fixation system comprising:
1. An implant capable of transitioning between a natural configuration and an insertion configuration, comprising: Bridge, a first anchoring member extending from the bridge, the first anchoring member including a segment extending outwardly of the bridge to provide an engagement point; a second anchoring member extending from the bridge, the second anchoring member including a segment extending outside of the bridge to provide an engagement point; an implant insertion device movable between a loaded position in which the implant insertion device jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby constraining the implant in its inserted configuration, and an unloaded position in which the implant insertion device releases the implant; the bridge includes first and second sides and first and second ends; the first anchoring member extends from the bridge at the first end of the bridge adjacent the first side of the bridge, the first anchoring member having a side-to-side width such that the segment of the first anchoring member extends outside of the bridge on its first side to provide the engagement point; the second anchoring member extends from the bridge at the second end of the bridge, the second anchoring member including a width between its sides, whereby the segment of the second anchoring member is a first segment and the engagement point is a first engagement point, such that the first segment extends exterior to the bridge at a first side of the bridge to provide the first engagement point, and further whereby the second anchoring member includes a second segment extending exterior to the bridge at a second side of the bridge to provide a second engagement point; a third tether member extends from the bridge at the first end of the bridge adjacent the second side of the bridge, the third tether member having a side-to-side width such that a segment of the third tether member extends exteriorly of the bridge at the second side of the bridge to provide an engagement point; The implant insertion device comprises: a body including a first end and a second end; an implant grip coupled to the body at a second end thereof, the implant grip movable relative to the body between an engaged position in which the implant grip jumps over the bridge to engage the segments of the first and third anchoring members at their engagement points and engage the first and second segments of the second anchoring member at their first and second engagement points, thereby restraining the implant in its insertion configuration, and a disengaged position in which the implant grip releases the implant; The implant grip comprises: an actuator coupled to the body and movable relative to the body, movement of the actuator advancing the implant grip between its engaged and disengaged positions; and a first blade and a second blade securable to the actuator in opposing relationship and defining a passage therebetween, the passage receiving the bridge of the implant therein and the first and second blades extending beyond the bridge to engage the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at their first and second engagement points to retain the implant and constrain the implant in its insertion configuration; The actuator, a first slider that is securable to the first blade; a second slider securable to the second blade; a spacer securable between the first slider and the second slider to space the first blade and the second blade to form the passage therebetween.
30. The body comprises: a tamp at the second end thereof; 30. The orthopedic fixation system of claim 29, further comprising: a slot communicating with an exterior of the body, the slot receiving the spacer therein; the first slider secured to the spacer adjacent a first surface of the body whereby the first blade extends beyond the tamp; and the second slider secured to the spacer adjacent a second surface of the body whereby the second blade extends beyond the tamp, such that the passage between the first blade and the second blade is located adjacent the tamp.
31. 31. The orthopedic fixation system of claim 30, wherein when the implant grip is in its engaged position, the tamp sits on the bridge of the implant, and further wherein the tamp remains on the bridge of the implant to prevent movement of the implant relative to the implant grip as the implant grip progresses from its engaged position to its disengaged position.
32. The implant insertion device comprises: a body including a first end and a second end; 32. The orthopedic fixation system of any one of claims 1 to 31, comprising an implant grip coupled to the body, the implant grip movable relative to the body between an engaged position where the implant grip jumps over the bridge and engages the segment of the first anchoring member at its engagement point and engages the segment of the second anchoring member at its engagement point, thereby restraining the implant in its insertion shape, and a disengaged position where the implant grip releases the implant.
33. A drill guide, the drill guide comprising: a body including a first passageway and a second passageway therethrough; a grip extending from the body; 32. The orthopedic fixation system of any one of claims 1 to 31, comprising a template depending from the body between the first passageway and the second passageway, the template including a slot, the first passageway located exterior to the slot on a first side of the slot and the second passageway located exterior to the slot on a second side of the slot.
34. 34. The orthopedic fixation system of claim 33, wherein the template is introduced to a fusion zone of the bone by using the grip to place the body on the bone such that the slot receives therein a fixation device inserted into the bone, and further wherein the first passage is located on the bone near a first side of the fixation device and adjacent a first side of the fusion zone, and the second passage is located on the bone near a second side of the fixation device and adjacent a second side of the fusion zone.
35. 34. The orthopedic fixation system of claim 33, wherein a distance between the first and second passageways is substantially equal to a distance between the first and second anchor members of the implant when the implant is in its insertion configuration plus a distance equal to a thickness of the template.
36. The orthopedic fixation system of claim 33 , wherein the body includes a third passageway therethrough located adjacent the first passageway.
37. The orthopedic fixation system of claim 36, wherein the body includes a fourth passageway therethrough located adjacent the second passageway.
38. A drill guide, the drill guide comprising: a body including a first passageway and a second passageway therethrough; a first grip extending from the body adjacent the first passage; a second grip extending from the body adjacent the second passage; a first template depending from the first grip, the first template including a slot having a first side and a second side; a second template depending from the second grip, the second template including a slot having a first side and a second side; the first passageway is located outside the slot of the first template and the second template on the first side of the slot; The orthopedic fixation system of any one of claims 1 to 31, wherein the second passage is located outside the slot of the first template and the second template on the second side of the slot.
39. 39. The orthopedic fixation system of claim 38, wherein the first template is introduced adjacent a first portion of the bone and the second template adjacent a second portion of the bone using at least one of the first grip and the second grip to position the body on a bone across its fusion zone such that the slots of the first template and the second template receive therein a fixation device inserted through the bone, and further wherein the first passage is located on the bone adjacent a first side of the fusion zone near a first side of the fixation device and the second passage is located on the bone adjacent a second side of the fusion zone near a second side of the fixation device.
40. 39. The orthopedic fixation system of claim 38, wherein a distance between the first and second passageways is substantially equal to a distance between the first and second anchoring members of the implant when the implant is in its insertion configuration.
41. The orthopedic fixation system of claim 38 , wherein the body includes a third passageway therethrough located adjacent the first passageway.
42. The orthopedic fixation system of claim 41 , wherein the body includes a fourth passageway therethrough located adjacent the second passageway.
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