The present application relates to surgical instruments used during the insertion of spinal implants and methods of using such instruments. More particularly, the embodiments of the invention relate to modular instruments including a handle that can be oriented to various positions and angles suited for various interbody fusion procedures requiring insertion of intervertebral implants.
Intervertebral implants are commonly used in spinal surgery in which an implant (e.g., a spacer or cage) is placed in the disc space between two vertebrae to be fused together. One such type of application is an interbody fusion procedure. At least a portion of the disc is typically removed before the implant is positioned in the intervertebral space. The implant may be supplemented with bone graft material to promote fusion of the vertebrae. These procedures may also be performed in conjunction with other types of fixation, such as pedicle screw fixation, to provide additional stability, particularly while the vertebrae fuse together.
Interbody fusion procedures can be distinguished by the type of implant used, by their location along the spine (cervical, thoracic, or lumbar, for example), and by the surgical approach to the intervertebral space. Different surgical approaches may require the use of certain surgical instruments and implants which are designed or suited for the particular approach (for instance, anterior, posterior, and lateral approaches). Anterior to psoas approach (ATP) and direct lateral interbody fusion (DLIF) are examples of interbody fusion techniques performed along a lateral aspect. ATP techniques typically include positioning an intervertebral implant into the intervertebral space from a direction diagonal to the medial-lateral direction (i.e., an angled approach). On the other hand, DLIF techniques typically include positioning an intervertebral implant into the intervertebral space from a direction directly along the medial-lateral direction (i.e., a non-angled approach).
When it is desired to insert an implant to a final position that is angled with respect to the axis of insertion, particularly in an ATP procedure, specialized instruments are often useful in allowing final placement of the implant while maintaining a small surgical site. For example, angled instruments can permit access to more of the intervertebral disc space than a straight instrument may allow.
Further improvement is desired in the field of spinal implant instrumentation for devices that have increased functionality and durability for multiple uses.
Some aspects herein relate to an implant insertion instrument capable of modulating between straight and angled configurations, the instrument having a handle assembly including a handle extending away from the instrument. The handle assembly may be configured to allow the handle to rotate around the body of the instrument to discrete positions and to pivot between a forward and backward positions along the longitudinal axis of the instrument. In the forward position, the handle may be perpendicular to the longitudinal axis of the body of the instrument, while in the backward position, the handle may be diagonal to the longitudinal axis of the instrument. The handle assembly may also include a casing rotatably disposed around the central body of the handle assembly and having a receptacle extending therefrom, the receptacle configured to receive and attach to an end portion of the handle. The casing may have an interior region wider than the end portion of the handle such that the handle can shift between multiple positions therein.
The handle may be capable of actuating between an engaged state and a disengaged state without being disconnected from the handle assembly. The engaged state may be when a portion of the handle is inserted into a central body of the handle assembly or the instrument thereby creating a connection. The disengaged state may be when this connection is broken between the handle and the central body of the handle assembly or the instrument by temporarily retracting an insertion component of the handle away from the instrument, while the handle remains attached to the casing. The insertion component of the handle may be connected to an external collar that can be used to withdraw the insertion component and place the handle in the disengaged state. When in the disengaged state, the handle may be configured to rotate around and pivot along the longitudinal axis of the instrument while the handle is still connected to the casing. This allows the handle of the instrument to be oriented at different angles and extend in different directions from the instrument. In this manner, the location and angle of the handle can be adjusted to best fit various approaches for implant insertion.
In another aspect, a surgical instrument for implanting spinal implants may include a shaft, a sleeve, and a handle assembly. The shaft, defining a longitudinal axis, may have a slotted portion with first slots and second slots. The sleeve may be rotatably disposed around the slotted portion. The handle assembly may be pivotably attached to the sleeve by a pivot pin and may have a positioning tip that may be sized to be received in the first and second slots. The handle assembly may pivot about the pivot pin between a first position and a second position. In the first position, the positioning tip may engage one of the first slots. In the second position, the positioning tip may engage one of the second slots. In such arrangements, the surgical instrument may further include an actuator that may be disposed adjacent to the sleeve portion for engaging and disengaging the positioning tip with one of the first and second slots. In such arrangements, the actuator may be spring biased to engage the positioning tip with one of the first and second slots.
In other arrangements, each of the plurality of first slots are aligned with the plurality of second slots. The plurality of first and second slots may be disposed in the slotted section of the body portion. The slotted portion may include a non-angled portion and an angled portion. The first slots may be disposed radially around the non-angled portion, and the second slots may be disposed radially around the angled portion. The sleeve may include inner surfaces complementary to the non-angled and angled portions.
In accordance with another aspect, a handle assembly of an implant inserter may be adjusted by a process. In the process, a tip of a handle may be disengaged from one of a plurality of first slots in a shaft of the inserter. Next, the handle may be pivoted from a first position to a second position. Subsequently, the handle may be rotated about the shaft. Finally, the tip of the handle may engage with one of a plurality of second slots in the shaft. In such arrangements, the tip may be retracted and the handled pivoted back to the first position from the second position. The first position may be orthogonal to the longitudinal axis of the shaft and the second position is diagonal to the longitudinal axis of the shaft.
In other arrangements, in the process, the handle may be rotated about the shaft before engaging the tip of the handle. The tip of the handle may be retracted by retracting a collar disposed around an exterior of the handle and connected to an internal portion of the tip of the handle. After retracting the tip of the handle, rotating the handle by any one of 45°, 90°, 135°, 180°, 225°, 270°, 315°, or 360° around a body portion of the shaft. In such arrangements, the tip may be inserted into any one of a plurality of slots radially disposed around the body portion.
In some other arrangements, in the process, an apparatus may be disposed in a hollow annulus of the shaft. The disengaging of the tip of the handle may include removing the tip from a one of the plurality of first slots by pulling an actuator away from the shaft of the inserter. Retracting the actuator may include compressing a spring disposed within the handle. Engaging the tip may include the tip being inserted into one of the plurality of second slots in the shaft of the inserter by releasing the actuator such that the spring advances the tip toward the shaft of the inserter as the spring expands. Pivoting the handle may include holding the actuator such that the tip remains in a disengaged position.
In accordance with another aspect, a surgical instrument for inserting implants may include a body portion, a handle assembly, a sleeve portion. The body portion, defining a longitudinal axis, may have a first slot and a second slot. The handle assembly may have a handle or handgrip, a positioning tip, and a pivot pin. The sleeve portion may be disposed around the body portion and may have an extension portion that extends away from the body portion. The pivot pin may be rotatably engaged with or attached to the extension portion of the sleeve portion such that the handle may pivot between a first portion and a second position. The handle (i.e., handgrip) may be orthogonal to the longitudinal axis of the body portion in the first position and may be diagonal to the longitudinal axis of the body portion in the second position. The positioning tip of the handle may be coaxially aligned with the first slot in a first segment of the body portion when the handle is in the first position. The positioning tip of the handle may be coaxially aligned with the second slot in a second segment of the body portion when the handle is in the second position. In such arrangements, the body portion may include a plurality of first slots and a plurality of second slots. Both the plurality of first and second slots may be radially disposed around the body portion. The plurality of second slots may be oriented diagonal to the longitudinal axis.
In other arrangements, the body portion may include a distal section, an intermediate section, and a proximal section. The intermediate section may have the first segment and second segment therein. The distal section may have a larger diameter than the intermediate section. The second segment of the body portion may define a diameter that increases in the distal direction. The sleeve portion may be rotatably disposed around the intermediate section of the body portion. The handle may include an elongated slot arranged such that the pivot pin extends therethrough. The body portion may define a hollow annulus extending therethrough. The handle may be threadably attached to a connector component that is configured to connect the handle and the positioning tip, and the handle may extend away from the body portion. The handle assembly may be attached to a proximal end of a barrel portion of the surgical instrument.
In yet other arrangements, the extension portion of the sleeve portion may define a hollow interior configured to receive an end portion of the handle. The hollow inter of the extension portion may have an hourglass-like shape to allow the end portion of the handle to pivot between the first and second positions. The sleeve portion and handle may rotate around the body portion in unison. The handle may rotate around the body portion while oriented in the first position or second position. The end portion of the handle may include the positioning tip and the connector component. The connector component may have a hollow chamber configured to receive a spring and at least a portion of the positioning tip. The spring may be disposed between the positioning tip and the connector component within the hollow chamber. The handle may include a collar (i.e., an actuator) that may be slidably disposed around the hollow chamber and configured for engaging and disengaging the positioning tip with either one of the first or second slots. The connector component may include a backstop portion disposed adjacent to the hollow chamber. The backstop portion may extend radially out from the connector component and configured to restrict movement of the collar.
In yet in other arrangements, a cap may be threadably disposed on the proximal section of the body portion such that the cap is adjacent to the sleeve portion. The cap may be configured to prevent the sleeve from moving along the longitudinal axis of the body portion in the proximal direction. In some other arrangements, the first and second slots may have an oval shape. In such arrangements, the positioning tip may have an insertion portion that has an oval shape that conforms to the first and second slots. The insertion portion may have a smaller thickness than the remainder of the positioning tip. The insertion portion of the positioning tip may be the only feature of the handle that contacts the body portion. In some other arrangements, the sleeve portion covers the plurality of the first and second slots such that at least one of each of the plurality of first and second slots are aligned with a hollow interior of the extension portion of the sleeve at any given time or position.
In another arrangement, a surgical instrument for implanting spinal implants may include a shaft, a sleeve, and a handle assembly. The shaft, defining a longitudinal axis, may have a slotted portion that defines a first set of slots and a second set of slots. The sleeve may be rotatably disposed around the slotted portion. The handle assembly may be pivotably attached to the sleeve and may have a positioning tip that may be sized to be received by each of the first and the second set of slots. The handle assembly may pivot about a pivot point between a first position and a second position. In the first position, the positioning tip may be oriented to engage a slot of the first slots. In the second position, the positioning tip may be oriented to engage a slot of the second set of slots. In such arrangements, the surgical instrument may further include an actuator that may be disposed adjacent to the sleeve portion, and the actuator may be configured for engaging and disengaging the positioning tip with a slot of the first and the second set of slots. In such arrangements, the actuator may be spring biased to engage the positioning tip with a slot of the first and the second set of slots.
In other arrangements, each slot of the first set of slots is aligned with a respective slot of the second set slots. The slotted portion may have a non-angled portion that defines a constant diameter and an angled portion that may extend from the non-angled portion to a larger portion that defines a diameter larger than that of the non-angled diameter. The first set of slots may be disposed radially around the non-angled portion, and the second set of slots may be disposed radially around the angled portion. The sleeve may include inner surfaces complementary to the non-angled and angled portions. The handle assembly may be pivotably attached to the sleeve by a pivot pin disposed at the pivot point.
In accordance with another aspect, a surgical instrument for inserting implants may include a body portion, a handle assembly and a sleeve portion. The body portion, defining a longitudinal axis, may have a first slot and a second slot. The handle assembly may have a handle or handgrip and a positioning tip configured to be retracted partially into the handle. The sleeve portion may be disposed around the body portion and may have an extension portion that extends away from the body portion. The handle may be pivotably attached to the sleeve portion such that the handle may pivot between a first portion and a second position. The handle (i.e., handgrip) may be orthogonal to the longitudinal axis of the body portion in the first position and may be oblique to the longitudinal axis of the body portion in the second position. The positioning tip of the handle may be disposed in the first slot in a first segment of the body portion when the handle is in the first position. The positioning tip of the handle may be disposed in the second slot in a second segment of the body portion when the handle is in the second position. In such arrangements, the body portion may include a plurality of first slots and a plurality of second slots. Both the plurality of first and second slots may be radially disposed around the body portion, and a respective longitudinal axis of each slot of the plurality of second slots may be oblique to the longitudinal axis.
The body portion may include a distal section, an intermediate section, and proximal section. The intermediate section may include the first segment and the second segment therein. The second segment may extend between the first segment and the distal section, and the distal section may have a larger diameter than that of the first segment of the intermediate section. The handle may include an elongated slot and a pivot pin that extends through the elongated slot. The handle may be threadably attached to a connector component that connects the handle and the positioning tip, and the handle may extend away from the body portion. The handle portion may include an end portion. The end portion of the handle may be disposed within the hollow interior of the extension portion. When the positioning tip is retracted from the body portion, the sleeve and the handle may rotate around the body portion while the handle is in the first position or the second position. The positioning tip may have an insertion portion having an oval shape that conforms to the first and second slots. The insertion portion may have a smaller thickness than the remainder of the positioning tip. The insertion portion of the positioning tip may be the only feature of the handle that contacts the body portion.
In accordance with yet another aspect, a surgical instrument for inserting implants may include a body portion, a handle assembly and a sleeve portion. The body portion may define a longitudinal axis. The body portion may have a slotted portion that defines a first slot and a second slot that are spaced apart from each other along the longitudinal axis of the body portion. The handle assembly may have a handle and a positioning tip that is slidably attached to the handle. The positioning tip may be partially disposed within the handle. The sleeve portion may be disposed around the slotted portion of the body portion and configured to rotate around the body portion when the positioning tip is retracted into the handle. The sleeve portion may have an extension portion that extends away from the body portion. The handle may be pivotably attached to the sleeve portion such that the handle can pivot between a first position and a second position. The handle may be orthogonal to the longitudinal axis in the first position and oblique to the longitudinal axis in the second position. The positioning tip of the handle may be disposed in the first slot in a first segment of the body portion when the handle is in the first position and may be disposed in the second slot in a second segment of the body portion when the handle is in the second position. The second segment may define a larger diameter than that of the first segment.
A more complete appreciation of the subject matter of the present disclosure and the various advantages thereof may be realized by reference to the following detailed description which refers to the accompanying drawings, in which:
As used herein unless stated otherwise, the term “anterior” means toward the front part of the body, and the term “posterior” means toward the back part of the body. When referring to specific directions in the following discussion of a certain device, the terms “proximal” and “distal” are to be understood in regard to the device's orientation and position during exemplary application to human body. Thus, the term “proximal” means closer to the operator or in a direction toward the operator, and the term “distal” means more distant from the operator or in a direction away from the operator. In addition, the terms “about,” “generally,” and “substantially” are intended to mean that deviations from absolute are included within the scope of the term so modified.
In a first aspect, the present disclosure relates to a modular surgical instrument. The instrument may include a handle configured to pivot in a direction along the longitudinal axis of the shaft of the instrument, such as shown in
In one embodiment, instrument 10 includes a shaft 12, a sleeve 14, and a handle assembly 16 as shown in the drawings. As best shown in
Body portion 6 includes a distal portion 61, an intermediate section 62-63, a proximal portion 64, and a plurality of slots that are radially disposed around shaft 11, as best shown in
Sleeve 14 includes a central anulus 25 that wraps around body portion 6 and an extension portion 21 that extends away from body portion 6, as best shown in
Referring to
Continuing with the embodiments depicted in
As best shown in
Continuing with
As shown in
In another aspect, the present invention relates to a kit that may include a surgical instrument having a rotatable and pivotable handle, such as handgrip 11, along with implants, for example, but no limited to, spinal implants of various shapes and sizes. The kit may also include additional surgical tools such as retractors and cutting tools that may be used in a surgical procedure.
In yet another aspect, the present disclosure relates to a method of pivoting a handle of a surgical instrument along the longitudinal axis of the shaft of the instrument. For example, handgrip 11 may pivot from a first position to a second position by retracting positioning tip 19 away from a normal slot 65 such that spring 15 is compressed within hollow chamber 76 of connector 13 by pulling actuator 17 toward backstop 74 and holding the actuator in this retracted position. Once the positioning tip 19 is fully disengaged from body portion 6, connector 13 may be tilted by pulling handgrip 11 proximally such that first end 46 of positioning tip 19 pivots about pivot pin 28 toward the distal tip of instrument 10 within cavity 23 of sleeve 14 as the handgrip pivots away from the distal tip of the instrument. In other words, pulling handgrip 11 in a proximal direction causes positioning tip 19, connector 13, and handgrip to pivot about pivot pin 28 such that the central axis of the connector becomes diagonal (i.e., oblique) to the longitudinal axis of body portion 6, as shown in
In another aspect, the present disclosure relates to a method of rotating a handle of a surgical instrument around the longitudinal axis of the shaft of the instrument. For example, handgrip 11 may rotate from a first location to a second location by retracting positioning tip 19 away from body portion 6 such that spring 15 is compressed within hollow chamber 76 of connector 13 by pulling actuator 17 toward backstop 74 and holding the actuator in this retracted position. Once the positioning tip 19 is fully disengaged from body portion 6, handgrip 11 may be rotated by moving handgrip 11 around body portion 6, as shown in
In another aspect, the present disclosure relates to a method of rotating and pivoting a handle of a surgical instrument around and along the longitudinal axis of the shaft instrument. For example, handgrip 11 may rotate from a first location to a second location and pivot from a first position to a second position by retracting positioning tip 19 away from body portion 6 such that spring 15 is compressed within hollow chamber 76 of connector 13 by pulling actuator toward backstop 74 and holding the actuator in this retracted position. Once the positioning tip 19 is fully disengaged from body portion 6, handgrip 11 may be rotated around and pivoted along body portion 6 by moving handgrip 11 around and along the longitudinal axis of the body portion and/or the shaft of instrument 10, as shown in
In another aspect, the present disclosure relates to a method of pivoting a handle of a surgical instrument along the longitudinal axis of the shaft instrument and titling the orientation of an implant attached to the tip of the instrument. For example, handgrip 11 may reorient to a diagonal position by disengaging positioning pin 19 and pivoting the handgrip as described above. Before or after handgrip 11 has been pivoted to the diagonal position and positioning tip 19 has inserted into body portion 6, implant 3 may be connected to instrument 10 by attaching implant to the tip of the instrument via an attachment mechanism. Once implant 3 has been attached to instrument 10, implant 3 may be reoriented by tilting the implant such that the longitudinal axis of the implant is diagonal to the longitudinal axis of the shaft of the instrument, as shown in
It is to be understood that the disclosure set forth herein includes any possible combinations of the particular features set forth above, whether specifically disclosed herein or not. For example, where a particular feature is disclosed in the context of a particular aspect, arrangement, configuration, or arrangement, that feature may also be used, to the extent possible, in combination with and/or in the context of other particular aspects, arrangements, configurations, and arrangements of the technology, and in the technology generally.
Furthermore, although the technology herein has been described with reference to particular features, it is to be understood that these features are merely illustrative of the principles and applications of the present technology. It is therefore to be understood that numerous modifications, including changes in the sizes of the various features described herein, may be made to the illustrative arrangements and that other arrangements may be devised without departing from the spirit and scope of the present technology. In this regard, the present technology encompasses numerous additional features in addition to those specific features set forth in the claims below. Moreover, the foregoing disclosure should be taken by way of illustration rather than by way of limitation as the present technology is defined by the claims set forth below.
The present application claims priority to U.S. Provisional Application No. 63/531,390, filed Aug. 8, 2023, the contents of which are incorporated herein by reference.
Number | Date | Country | |
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63531390 | Aug 2023 | US |