Patent Application
20180317975
Spinal stenosis often involves narrowing of the spinal canal and pinching of the spinal cord and nerves, causing pain in the back and legs. Typically, with age, a person's ligaments may thicken, intervertebral discs may deteriorate, and facet joints may break down contributing to spinal stenosis. Injury, heredity, arthritis, changes in blood flow, and other causes may also contribute to spinal stenosis. Treatments for such conditions vary, though such treatments typically involve open surgery to repair tissue and/or allow for implantation of an implant.
A recent advancement, minimally invasive surgery, is becoming increasingly important—patient trauma and recovery time is vastly reduced, amongst other benefits. In general, such surgeries involve making a small incision in the skin and tissue of a patient, inserting a minimally-invasive access portal (e.g., a cannula or retractor) in the incision, and subsequently performing surgery through the access portal in a less-intrusive manner. In spinal surgery, as an example, an implant or other device is moved through the access portal and engaged with part of the patient's spine (e.g., to assist with fusion, stabilization, etc.). Yet, it is often difficult to manipulate the implant or other device through the access portal. It is also desirable to use an access portal with the smallest exposure (e.g., diameter) possible so that the surgery exacts the least trauma on the patient. Current instruments and implants are cumbersome in this regard, and make it difficult to use smaller-footprint access portals.
Therefore, there exists a need for improved surgical instruments, implants, and methods to overcome the foregoing deficiencies.
A first aspect of the invention provides a surgical system comprising an implant and a first instrument. The first instrument comprises a hollow body and an actuation member movably engaged to a locking mechanism, wherein movement of the actuation member from a first position to a second position causes the locking mechanism to move from an unlocked state to a locked state. The first instrument further includes a connection mechanism engageable with the implant, wherein, after engagement of the connection mechanism with the implant, movement of the locking mechanism from its unlocked state to its locked state locks the connection mechanism to the implant, and movement of the locking mechanism from its locked state to its unlocked state unlocks the connection mechanism from the implant, the implant being rotatable while engaged to the connection mechanism from a first orientation in which the implant has a first footprint in a horizontal direction to a second orientation in which the implant has a second footprint in the horizontal direction smaller than the first footprint. The first instrument also has an activation sleeve engaged to a pivoting member, the pivoting member having a surface shaped to contact the implant and retain the implant in its second orientation.
In embodiments of this first aspect, the pivoting member is engaged to the activation sleeve via a spring that biases the pivoting member into a first orientation transverse to the activation sleeve. Further, the system may include a drive shaft operatively engaged to the actuation member and to the locking mechanism, the actuation member comprising a knob rotatably engaged to the instrument, wherein rotation of the knob relative to the instrument causes longitudinal movement of the drive shaft, thereby resulting in movement of the locking mechanism from its unlocked state to its locked state.
A second aspect of the invention includes a method of performing surgery comprising (i) engaging a first surgical instrument with an implant, (ii) moving a pivoting member of the first surgical instrument from a first distal position to a second relatively more proximal position, (iii) rotating the pivoting member from a first orientation in which the pivoting member occupies a first footprint in a horizontal direction to a second orientation in which the pivoting member occupies a second footprint in the horizontal direction smaller than the first footprint, (iv) rotating the implant from a first orientation in which the implant occupies a first footprint in the horizontal direction to a second orientation in which the implant occupies a second footprint in the horizontal direction smaller than the first footprint, (v) subsequently biasing a surface of the pivoting member against the implant so that the pivoting member and the implant are secured in their second orientations, (vi) inserting the instrument with the implant attached in its second orientation through an access portal extending through skin and tissue of a patient, (vii) after the implant passes through the access portal, rotating the pivoting member from its second orientation back to its first orientation, (viii) engaging the pivoting member with the implant so that the implant is rotated from its second orientation back to its first orientation, and (ix) engaging the implant to anatomy in the patient. Although some steps may be numbered in the disclosure, no ordering is implied by the numbering and certain steps of the method may be performed in a different order than set forth by the numbering.
In embodiments of the second aspect, the method further comprises (i) inserting a second surgical instrument through the first surgical instrument, (ii) engaging the second surgical instrument with the implant, and (iii) moving the second surgical instrument while engaged to the implant so that the implant either expands or contracts.
A third aspect of the invention includes a surgical system comprising an implant and a first instrument. The first instrument includes a body and an actuation member movably engaged to a locking mechanism, wherein movement of the actuation member from a first position to a second position causes the locking mechanism to move from an unlocked state to a locked state. The instrument also has a connection mechanism engageable with the implant, wherein, after engagement of the connection mechanism with the implant, movement of the locking mechanism from its unlocked state to its locked state locks the connection mechanism to the implant, and movement of the locking mechanism from its locked state to its unlocked state unlocks the connection mechanism from the implant, the implant being rotatable while engaged to the connection mechanism from a first orientation in which the implant has a first footprint in a horizontal direction to a second orientation in which the implant has a second footprint in the horizontal direction smaller than the first footprint. The first instrument further comprises an activation sleeve engaged to a pivoting member, the pivoting member being rotatable relative to the activation sleeve from a first orientation in which the pivoting member has a first footprint in the horizontal direction to a second orientation in which the pivoting member has a second footprint in the horizontal direction smaller than the first footprint, wherein the pivoting member has a surface shaped to contact the implant and retain the implant in its second orientation when the pivoting member is in its second orientation.
In certain embodiments, the pivoting member is movable in a longitudinal direction from a first distal position to a second more proximal position and, when the pivoting member is in the first distal position with the surface of the pivoting member engaged to the implant, the pivoting member and the implant are fixedly secured their second orientations.
In a fourth aspect of the invention, a surgical instrument for use in minimally invasive surgery is provided, the surgical instrument comprising a rotational member, a first sliding member, a second sliding member, a compressible member, and a pivoting member, wherein an uninterrupted cannulation extends through each of the rotational member, first sliding member, second sliding member, compressible member and pivoting member, the cannulation adapted to allow passage of a second instrument therethrough. Embodiments of this fourth aspect may encompass wherein the pivoting member includes an end adapted to engage with an implant and rotate the implant from a first position to a second position. In the first position, the implant may have a first footprint and, in the second position, the implant may have a second footprint that is smaller than the first footprint. In other embodiments, the second instrument is engageable with an implant to expand or contract the implant.
The instruments and methods provided herein are useful for inserting implants, in a minimally-invasive manner, through a relatively small access portal in a first orientation where the implant has a first footprint, and then moving the implant into a second orientation once the implant passes through the access portal so that the implant has a second footprint larger than the first footprint. Thus, the trauma and time frame of a surgical procedure can be improved.
A more complete appreciation of the subject matter of the present invention and of the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:
In describing certain aspects of the present invention, specific terminology will be used for the sake of clarity. However, the invention is not intended to be limited to any specific terms used herein, and it is to be understood that each specific term includes all technical equivalents, which operate in a similar manner to accomplish a similar purpose.
Although a variety of implants are usable with the instruments disclosed herein, Applicant has developed a number of implants that are particularly suitable for use with instrument 10. As an example, various implants are disclosed in Applicant's co-pending application U.S. Patent Pub. No. 2013/0144339 (“the '339 Publication”), filed as U.S. application Ser. No. 13/679,986, which is hereby incorporated by reference herein. It is understood that any of the implants disclosed in the '339 Publication are usable with the instruments described herein, although a particular embodiment of an implant from the '339 Publication is referred to throughout the present application as an example. The particular implant of the '339 Publication referenced herein is implant 4100 of
Continuing with the exemplary implant, as reproduced in
Actuator adjuster 4134 also includes one or more female mating features 160 for engaging with a tool 140 (described below). Tool 140 is used to rotate actuator adjuster 4134 and cause expansion or contraction of wings 4110 of implant 4100, as detailed above. Additionally, body 4144 includes female mating features 170 for engaging with a part of instrument 10, as described in more detail below.
Referring now to
Continuing with this embodiment, a sleeve 70 is positionable over spring clip 60 and is movable relative thereto for releasably locking arms 62 to female mating features 170, and thus implant 4100. As an example, sleeve 70 includes an opening 74 through which arms 62 may extend. Sleeve 70 is moveable from a first position in which arms 62 extend out of opening 74 and are not covered or are only partly covered by sleeve 70, thereby allowing arms 62 to assume their biased orientation (e.g., spaced apart), to a second position in which sleeve 70 covers part or all of arms 62 causing arms 62 to move toward each other. In use, arms 62 are engageable with female mating features 170 of implant while sleeve 70 is in its first position. Alternatively, in the first position, arms 62 can be positioned adjacent female mating features 170. Sleeve 70 is then movable to its second position to cause arms 62 to move towards each other, or at least prevent arms 62 from moving away from each other. In the second position, hooks 64 securely engage female mating features 170, and arms 62 are locked in position in engagement with female mating features 170. In other words, in the second position, sleeve 70 prevents arms 62 and hooks 64 from disengaging with female mating features 170 since sleeve 70 covers arms 62 and arms 62 are unable to move outwards away from each other.
Movement of sleeve 70 from its first position to its second position is achieved by a user interface, such as a rotatable knob 22 of instrument 10. Indeed, in an embodiment, a set of drive rails 50 are attached (e.g., welded) to slots 72 on sleeve 70 and rotation of knob 22 causes movement of drive rails 50 and sleeve 70. As an example, drive rails 50 extend from sleeve 70 and are connected to a threaded drive insert 36 positioned in a cavity 23 of knob 22. An unthreaded part 38 of drive insert 36 includes a set of cutouts or recesses 40, and drive rails 50 are securely attached to drive insert 36 within such recesses 40 (e.g., by welding). A threaded knob insert 30 is also provided within cavity 23 of knob 22, which is configured to receive the threaded part of drive insert 36. In an embodiment, cavity 23 extends to a proximal bore 26 within knob 22, and knob insert 30 is securely affixed (e.g., welded or adhered) within internal cavity 23 and proximal bore 26, as shown in the cross-section of
Continuing with the embodiment shown in
Spring clip 60 may additionally include slots 66 for accommodating and/or guiding drive rails 50 during rotation of knob 22. In an embodiment, drive rails 50 are not securely attached to slots 66 and, instead, drive rails 50 slide along slots 66. Drive rails are therefore movable relative to and are in part guided by slots 66 of spring clip 60 during rotation of knob 22.
Continuing with the embodiment of
One example of a swivel tip 100 is shown in
In one embodiment, activation sleeve 80 is a hollow sleeve designed to fit over second projection 52 of handle 20 at a first end 84, and receive spring clip 60 and sleeve 70 at a second end 86. Activation sleeve 80 also includes a gripping part 82 and openings 88 and, once first end 84 is positioned over second projection 52 of handle 20, pins 90 are insertable into openings 88 so as to ride within a set of channels 54 of handle 20. Activation sleeve 80 can therefore reciprocate relative to handle 20 in a controlled manner by an amount equal to the length of channels 54.
Activation sleeve 80 is also associated with an activation sleeve collar 120, which has a main body 122 with openings 124, a projection 128 extending from main body 122, and side channels 126 disposed on main body 122. Pins 90 are insertable into openings 88 of activation sleeve 80, through channels 54 of handle 20, and subsequently into openings 124 of activation sleeve collar 120. Additionally, a spring 130 may be positioned in a pocket 58 of handle 20 (
To move activation sleeve 80 proximally, a user may opt to grasp gripping part 82 of activation sleeve 80 and pull it in a proximal direction against the force of spring 130. This causes the step of activation sleeve collar 120 to act on and compress spring 130, moving collar 120 and thus activation sleeve 80 attached thereto in a proximal direction. Through the action of spring 130, and the connection between activation sleeve 80 and activation sleeve collar 120 via pins 90, a user is therefore able to easily move activation sleeve 80 proximally by pulling on gripping part 82, and also move activation sleeve 80 distally by simply releasing gripping part 82. Such movement of activation sleeve 80 facilitates or causes corresponding movement of swivel tip 100, as described below.
Further to this embodiment, second end 86 of activation sleeve 80, as shown in
In an embodiment, swivel tip 100 needs to be manually placed in the vertical orientation after retraction of activation sleeve 80 due to the constant biasing of torsion springs 112. In other words, once activation sleeve 80 is pulled proximally a sufficient distance, the user must manually rotate swivel tip 100 to its vertical orientation. In an embodiment, activation sleeve 80 may include a lock or other mechanism (not shown) for retaining sleeve 80 in its proximal position. The lock (not shown) may be released using a release mechanism (not shown) after moving swivel tip 100 to its vertical orientation. The interaction of swivel tip 100 with an implant, such as implant 4100, will be discussed below.
Instrument 10 is usable along with instrument 140—and optionally an access portal such as a cannula, retractor, or the like—to insert implant 4100 into the body of a patient in a minimally-invasive manner, as follows. In an embodiment, knob 22 may first be rotated in a counterclockwise direction to cause likewise counterclockwise rotation of knob insert 30, resulting in proximal movement of drive insert 36 (and drive rails 50 and sleeve 70 attached thereto). In this condition, arms 62 of spring clip 60 may extend from opening 74 of sleeve 70 with sleeve 70 in its first position not covering or only covering a portion of arms 62. Arms 62 of spring clip 60 are therefore able to, for example, move slightly (e.g., outwards) and engage with female mating features 170 of body 4144 of implant 4100. As arms 62 pass over female mating features 170, hooks 64 engage with female mating features 170, thereby engaging instrument 10 with implant 4110. Then, knob 22 may be rotated clockwise to cause likewise clockwise rotation of knob insert 30, resulting in distal movement of drive insert 36 (and drive rails 50 and sleeve 70 attached thereto). Knob 22 is rotated until resistance is felt and sleeve 70 is in its second position covering arms 62 of spring clip 60 and placing arms 62 in a locked state. In other words, with sleeve 70 covering arms 62, arms 62 are locked in engagement with female mating features 170 of implant 4110 and instrument 10 is securely engaged with implant 4100. In this condition, implant 4100 and swivel tip 100 are in their horizontal orientations with activation sleeve 80 biased in a distal direction by way of spring 130. Indeed, spring 130 is positioned about projection 128 of activation sleeve collar 120 and within pocket 58 of handle 20. Pins 90 are also inserted through openings 88 of activation sleeve 80, through channels 54 in handle 20, and into openings 124 of activation sleeve collar 120. As spring 130 acts on activation sleeve collar 120 (e.g., the step between main body 124 and projection 128), collar 120 and consequently activation sleeve 80 are forced in a distal direction.
To move swivel tip 100 and implant 4100 from their horizontal orientations to their vertical orientations—for insertion through an access portal in a minimally-invasive manner—the user simply pulls gripping part 82 of activation sleeve 80 to move activation sleeve 80 proximally against the force of spring 130. In particular, activation sleeve collar 120 moves proximally against spring 130, while being guided by pins 90 inserted through openings 88 of activation sleeve 80 and channels 54 of handle 20. As activation sleeve 80 moves proximally, swivel tip 100 also moves proximally creating sufficient spacing from implant 4100 for swivel tip 100 to be rotated to its vertical orientation, as shown in
With implant 4100 and swivel tip 100 in their vertical orientations, instrument 10 with implant 4100 attached can be inserted through the minimally-invasive access portal. Since implant 4100 does not have a large footprint in its vertical orientation, it is possible to insert instrument 10 and implant 4100 through a relatively small access portal (e.g., an access portal having a diameter that is slightly larger than the footprint of implant 4100 in its vertical orientation). As implant 4100 approaches the surgical site, which in some embodiments is the spinal column of a patient, in particular the spinous processes, implant 4100 may exit the access portal and instrument 10 may be actuated to cause implant 4100 and swivel tip 100 to rotate back to their horizontal orientations. In particular, after implant 4100 exits beyond the extent of the access portal (e.g., the tips of the retractor blades or the cannula), the user may pull gripping part 82 of activation sleeve 80 proximally once more to cause swivel tip 100 to move proximally away from wings 4110 of implant 4100. With sufficient clearance between wings 4110 and swivel tip 100, torsion springs 112 may then cause swivel tip 100 to automatically assume its horizontal orientation. In other words, torsion springs 112, due to their natural bias, cause swivel tip 100 to rotate from its vertical orientation to its horizontal orientation. This causes swivel tip 100 to disengage from wings 4110 of implant 4100 and assume its horizontal orientation, while implant 4100 may remain in its vertical orientation.
Then, after release of gripping part 82, activation sleeve 80 can snap back to its normal distal position due to the force borne on activation sleeve collar 120 via spring 130. Such action causes swivel tip 100—in its horizontal orientation—to contact wings 4110 of implant 4100 and rotate implant 4100 from its vertical orientation (if it did not already rotate) to its horizontal orientation, as shown in
With implant 4100 in its horizontal orientation, wings 4110 can be positioned about the patient's spinous processes, in the manner described in the '339 Publication. Then, to secure implant 4100 to the patient's spinous processes, instrument 140 is used. In a particular embodiment, the user grasps handle 142 and inserts drive shaft 144 through instrument 10, specifically through knob cap 28 and the rest of the continuous cannulation of instrument 10, so that ears 146 engage female mating features 160 of actuator adjuster 4134. Due to knob cap 28's diameter, which is only slightly greater than the diameter of drive shaft 144, instrument 140 can be inserted through instrument 10 in a controlled manner. The user rotates handle 142 with ears 146 engaged to female mating features 160, causing actuator adjuster 4134 to rotate and move actuator 4132 inwards towards wings 4110 within body 4144, resulting in wings 4110 moving towards a compressed state. Wings 4110 can then be clamped to the patient's spinous processes with sufficient force to ensure implant 4100 is stably implanted in the patient. Such clamping is described more particularly in the '339 Publication.
Instrument 140 is subsequently removed from instrument 10 once implant 4100 is secure. The user may then rotate knob 22 counterclockwise so that sleeve 70 moves in a proximal direction back to its first position. Arms 62 of spring clip 60 are then free to disengage with female mating features 170 of body 4144, for instance simply by the user pulling proximally on gripping part 44 of handle 20 and causing hooks 64 to slide off female mating features 170. In other words, in its first position sleeve 70 does not cover or only partly covers arms 62 of spring clip 60 and, by pulling proximally on handle 20, the user can cause hooks 64 to simply slide off female mating features 170 to disconnect instrument 10 from implant 4100. With the above procedure, implant 4100 is implanted on the patient's spinous processes with less trauma, decreased operating time, and decreased recovery time due to the procedure's minimally-invasive nature.
In the devices depicted in the figures, certain structures are referenced. It is understood that other equivalent structures may be used. As an example, although knob 22 is described as being connected to handle 20 via two (2) pins 90 engaged in groove 48, it is contemplated that a single pin or more than two (2) pins 90 could be used. Additionally, groove 48 may extend entirely around first projection 46 of handle 20, or it may extend only partly around first projection 46. Further, biasing members other than spring 130 can be used in instrument 10 (e.g., a flexible/compressible cylinder, etc.)
Additionally, it is contemplated that instruments 10, 140 can be used with different types of implants. As an example,
As shown in
Although aspects of the invention herein have been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of certain features of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. For instance, the features described in connection with individual embodiments may be shared with others of the described embodiments.
It will also be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. In particular, each feature from the dependent claims may be shared with other features of other claims, to the extent technologically feasible, as if the claims were written in multiple dependent format.
This application is a divisional of U.S. application Ser. No. 15/084,020, filed on Mar. 29, 2016, the disclosure of which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15084020 | Mar 2016 | US |
| Child | 15969110 | US |
