Anterior to Psoas Instrumentation
20220346766 · 2022-11-03
Inventors
- Abram Reitblat (Monroe, NY, US)
- Steven F. Krause (Oakland, NJ, US)
- Spencer Popejoy (Ringwood, NJ, US)
- Shawn Graham (Morristown, NJ, US)
- Douglas G. Pedrick (Newburgh, NY, US)
Cpc classification
A61B17/0206
HUMAN NECESSITIES
A61B17/846
HUMAN NECESSITIES
International classification
Abstract
In one embodiment, the present disclosure relates to an instrument adapted for use in an anterior to psoas spinal access procedure. The instrument includes a body, a first arm and a second arm. A first rod extends from the first arm at an angle thereto while a second rod extends from the second arm at an angle thereto. Each of the first rod and the second rod include a length with a first portion and a second portion, the first portion having a convex surface perimeter and the second portion having a perimeter different from the first portion and being convex in part. In some embodiments, a kit includes the instrument and a blade adapted for use in conjunction with the instrument in an anterior to psoas spinal access procedure.
Claims
1-6. (canceled)
7. A blade for use in accessing hard tissue of a patient, the blade comprising: a body having a central portion and a distal portion extending from the central portion, a central longitudinal axis of the body being along a center of the central portion and a center of the distal portion, the central portion comprising: first and second lateral sides and an inner surface therebetween; a central longitudinal channel on the inner surface; and first and second longitudinal grooves on the first and second lateral sides, respectively, the first and second longitudinal grooves having a partially cylindrical shape, wherein portions of the inner surface between the central longitudinal channel and the respective lateral sides are concave; the distal portion tapering from the central portion to a tip, the tip being contoured to provide surface area contact when disposed on a curved surface, wherein the distal portion becomes further from a plane through lengths of the first and second longitudinal grooves moving from the central portion toward the tip.
8. The blade of claim 7, wherein the central portion further comprises a sub-channel within the central longitudinal channel, the sub-channel being narrower and shorter than the central longitudinal channel.
9. The blade of claim 7, wherein the distal portion further comprises third and fourth lateral sides, at least a portion of the third and fourth lateral sides defining a convex surface.
10. The blade of claim 9, wherein at least part of a second inner surface on the distal portion is concave.
11. The blade of claim 7, wherein the central longitudinal channel extends into the distal portion.
12. The blade of claim 7, wherein the distal portion is entirely in between a second plane through the first longitudinal groove and a third plane through the second longitudinal groove, wherein the second and third planes are orthogonal to the plane.
13. A blade assembly for use in accessing hard tissue of a patient, the blade assembly comprising: a blade including a central portion and a distal portion, a longitudinal dimension of the blade extending from a proximal end of the central portion to a tip of the distal portion, the central portion comprising: first and second lateral sides with a concave surface therebetween, the first and second lateral sides being oriented along the longitudinal dimension; a first longitudinal groove extending along the first lateral side; wherein a plane passes through the first and second lateral sides such that the concave surface is offset from the plane, the distal portion extending from the central portion to the tip such that the distal portion is furthest from the plane at the tip, and a first pin disposable in the first longitudinal groove, the first pin adapted for anchorage into hard tissue.
14. The blade assembly of claim 13, further comprising a second longitudinal groove extending along the second lateral side of the central portion, the second longitudinal groove sized for receipt of a second pin.
15. The blade assembly of claim 13, wherein the first pin includes a head at a proximal end of the first pin and a threaded portion adjacent a distal end of the first pin, the head having a diameter larger than a diameter of the first longitudinal groove.
16. The blade assembly of claim 13, wherein the distal portion narrows from the central portion to the tip.
17. The blade assembly of claim 13, wherein the blade further comprises a longitudinal central recess extending from the proximal end of the central portion to a location on the distal portion.
18. The blade assembly of claim 17, wherein the blade further comprises a longitudinal sub-recess, the longitudinal sub-recess being entirely within the longitudinal central recess.
19. The blade assembly of claim 18, wherein the longitudinal sub-recess is shorter than the longitudinal central recess.
20. The blade assembly of claim 17, further comprising a light emitting bar slidably engaged to the longitudinal central recess.
21. The blade assembly of claim 13, wherein the blade further comprises a proximal portion angled relative to the central portion, the proximal portion adapted for engagement to a handle or a rigid support.
22. A blade assembly for use in accessing hard tissue of a patient, the blade comprising: a blade having a central portion and a distal portion, a central linear axis passing through a centerline of the central portion, the distal portion extending to a tip and curving away from the central linear axis toward the tip, the central portion comprising: first and second longitudinal grooves on respective lateral sides of the central portion, a length of the first and second longitudinal grooves being shorter than a length of the blade, a first pin and a second pin, the first pin disposed in the first longitudinal groove and the second pin disposed in the second longitudinal groove, wherein the first pin is longer than the blade.
23. The blade assembly of claim 22, wherein the first and second longitudinal grooves include proximal openings and distal openings, the distal portion of the blade being entirety in between the distal openings and being offset from a plane through lengths of the first and second longitudinal grooves.
24. The blade assembly of claim 22, wherein the distal portion tapers from the central portion to the tip.
25. The blade assembly of claim 22, wherein the first and second pins include heads, the heads preventing the pins from entirely passing through the respective first and second longitudinal grooves.
26. A method of implanting the blade assembly of claim 22 into a bone, the method comprising: retrieving the blade assembly, positioning the blade at a desired location on a bone such that at least part of the distal portion is pressed against the bone; and driving the first pin and the second pin into respective locations on the bone to fix the blade in position relative to the bone.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The present disclosure will be better understood on reading the following detailed description of non-limiting embodiments thereof, and on examining the accompanying drawings, in which:
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DETAILED DESCRIPTION
[0043] Tools for accessing the spine using an anterior to psoas approach may include any number of retraction instruments and/or blades. For example, access to the spine 2 may be provided through a system that includes a retraction instrument 10 and blade 160 as shown in
[0044] Retraction instrument 10 is shown in more detail in
[0045] A more detailed view of one of the arms and rods is shown in
[0046] Retraction instrument 10 is advantageous in that it includes retraction structures in the form of rods with perimeters defined by convex surfaces, e.g., cylindrically shaped, and occupying a minimal cross-sectional area. The size and shape of the rods reduces the interference of the retraction instrument with the operative space, allowing a surgeon to approach the surgical site from many angles and positions. Additional operative space is also made available in view of the space between the arms from the main body to the rods. Further, the rounded surface of the rods reduces the risk of damaging internal organs of the patient during advancement of the instrument. Moreover, each rod is engineered to withstand a certain amount of deflection under loading. Put another way, the properties of the rods provide sufficient elastic flexibility to withstand deflection that can result from tissue bearing on the rods during use without reaching yield under the highest loads expected within a body of a patient. The rods as described are also usable in a retractor adapted for use in a lateral trans-psoas approach, such as the retractors described in the '328 Publication. Because the rods may be detached and reattached, it is envisioned that rods already attached to the retraction instrument may be detached and then reattached to a lateral trans-psoas retractor.
[0047] The retraction instrument may be varied in many ways. In one embodiment, a retraction instrument 110 is as shown in
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[0049] Turning to the rods used with the retraction instrument, in one example, as shown in
[0050] In one embodiment, a retraction instrument 210, shown in
[0051] In some examples of the retraction instrument, the attached rods may have an oblong, elliptical, ovular or any other cross-sectional shape as desired. In other examples, one or more of the rods may have a pointed tip shaped to engage bone upon loading thereon. Retraction instruments including such rods may be secured to a bone without a separate anchoring structure. Further examples of rod shapes and other rod details are provided in the '328 Publication, incorporated by reference above, and in WO2018/039228, the disclosure of which is hereby incorporated by reference herein in its entirety (“the '228 Publication”). In some examples, the body, arms and/or rods may be comprised of a monolithic structure in whole or in part. Thus, the body and arms may be a monolithic structure or an arm and a rod connected to the arm may be a monolithic structure. Further, the body, arms and rods may all be a single monolithic structure. In other examples, various combinations of the body, arms and rods may be integral. In further examples, a length of a body of a retraction instrument may be at an angle relative to a length of one or more arms attached thereto. Similarly, where the retraction instrument includes a rack, the rack may be at any angle relative to the central body and/or one or more of the arms. The angle between elements in these examples may be such that all structures are in a single plane or one or more structures may be angled out of plane with respect to the others. For example, a retraction instrument may include two arms passing through a single plane while the main body and handle extend at an angle from the arms out of the single plane. Similar variations are contemplated for an angle between the rods and the arms. And, a length of a first arm may be at an angle relative to a length of a second arm.
[0052] In other examples, a first rod on a retraction instrument may be different from a second rod. Any combination of the rods described in the '328 Publication and the '228 Publication may be included. In still further examples, the retraction instrument may include three or more rods with corresponding arms. The rod and arm combinations may be parallel with one another or one or more may be at an angle relative to the others. In yet another example, the rods may be attached to a single body without any arms.
[0053] In another aspect, the present disclosure relates to a pin holder 40 as shown in
[0054] The pin holder is advantageous in that it adds a bone securement feature to retraction instrument 10, 110, 210 and it is insertable after a portal is created to avoid having to pass a pointed tip on the bone pin of the pin holder through anatomy of the patient. Further, the position of the internal channel offset from the c-clip structure allows a surgeon to screw in a bone pin while the pin holder is engaged to a rod.
[0055] In another aspect, the present disclosure relates to blades. One embodiment of a blade is a double pin blade 60 shown in
[0056] Turning to central portion 62, central portion 62 has a linear length with a concave surface 71 on one side and a convex surface 81 on an opposite side. On opposite lateral sides of concave surface 71 are longitudinally extending first and second lateral grooves 72, 74, respectively, as best shown in
[0057] Tapered distal portion 63 extends from central portion 62 to a rounded tip 64 of the blade. As shown in
[0058] Opposite concave surface 71 is convex surface 81, as shown in
[0059] In another embodiment, a system includes double pin blade 60 and pins 90A, 90B. Pin 90A includes a cylindrical body extending from a head 91A to a tip 92A. A majority of a length of pin 90A includes a smooth surface, although a distal end portion 94A extending to tip 92A is threaded. Pin 90B is the same as pin 90A. In the system, each pin 90A, 90B is disposed in respective first and second lateral grooves 72, 74, as shown in
[0060] Double pin blade 60 is advantageous in that it is adapted to house up to two pins for securement of blade 60 to a bone structure. Indeed, when two pins are used to secure blade 60 to a bone structure, both rotational and axial securement are realized. Further, blade 60 includes a contoured tip 64 to improve surface area contact with curved surfaces, such as those on the spine.
[0061] In another embodiment, blade 160 is as shown in
[0062] In yet another embodiment, a double pin blade 260 is as shown in
[0063] In yet another embodiment, the present disclosure relates to a composite blade 360 that includes an outer blade component 370 and an inner blade component 380. Inner blade component 380 is narrower than outer blade component and is engageable with a groove 375 in outer blade component 370, as shown in
[0064] Another embodiment of the composite blade is shown in
[0065] The blade may be varied in many ways. Additional examples of blades, along with another view of blades 60 and 260, are illustrated in
[0066] In another aspect, the present disclosure relates to a kit. A kit may be contained in a single package as a system or in multiple packages that may be selected as needed by a surgeon to form a system. In one embodiment, a kit includes a retraction instrument and a blade. When referred to as part of a kit, a blade may be any blade described or otherwise contemplated in this disclosure. In another embodiment, a kit includes a retraction instrument and two or more blades. Any combination of blades may be included, either multiple blades of the same type, or different blade types. In yet another embodiment, a kit includes two or more retraction instruments and a single blade. When two or more retraction instruments are included, each instrument may be the same or may be different. In further embodiments, a kit may include two or more retraction instruments without any blades or may include two or more blades without any retraction instruments. In each of the above embodiments, the kit may also include multiple units of a single type of blade but in different sizes. It is also contemplated that the above kits may be further modified to include other surgical tools used in conjunction with the retraction instrument and blades. In some examples of the above embodiments, the kits contemplated herein may be accompanied by an instruction manual on how to perform one or more of the methods of using the contents of the kit.
[0067] In yet another embodiment of the kit, tools of the described anterior to psoas system are included as part of a larger kit including a lateral trans-psoas system, such as the system and subcomponents described in the '328 Publication. In some examples, such a kit includes a lateral trans-psoas retractor system, an anterior to psoas retraction instrument with two arms and two rods and a composite blade. In other examples, it includes a lateral trans-psoas retractor system and any combination of anterior to psoas tools as described in the other kit embodiments above. The lateral trans-psoas retractor system forming part of the kit may include any number of components and tools described in the '328 Publication.
[0068] In another aspect, the present disclosure relates to a method of accessing the spine using an anterior to psoas approach. As noted above, although the specific embodiments described herein are directed to procedures employing an anterior to psoas approach, other procedures, such as an ALIF procedure, are also contemplated. Prior to commencement of the surgical technique using the tools of the present disclosure, preparation of the patient is required. These preliminary steps include but are not necessarily limited to: Positioning the patient; identifying an incision location based on the targeted spinal location; and cutting through muscle layers to create an opening for accessing spine. In an anterior to psoas approach, external oblique, internal oblique, transversus abdominus and transversalis fascia tissues are penetrated to create an initial opening, or initial portal, so that the surgeon may identify the psoas muscle and/or other anatomy and use such anatomy to locate the spine. In certain examples, the techniques described herein may be used to access vertebrae at L3/L4, L4/L5 and L5/S1.
[0069] In one embodiment, with an initial portal 3 opened that is large enough so that tools may be advanced into the patient, as shown in
[0070] With blade 360 in position, rods 30, 34 of retraction instrument 10 are directed to an opposite side of the partially retracted opening from blade 360, as shown in
[0071] Because rods 30, 34 of retraction instrument 10 retract tissue but are also spaced apart, and because arms 20, 24 are spaced apart, retraction instrument 10 provides a unique advantage in that a surgeon has more space to operate once surgical access portal 9 is created. For example, if the surgeon attaches an implant onto an insertion instrument, the surgeon may direct the instrument in between the rods or at steeper angles relative to the surgical access portal than would otherwise be possible with a traditional blade. Similar advantages are available for the insertion of disc preparation instruments.
[0072] Optionally, additional blades 760, shown in phantom in
[0073] In some variations of the method added stability, i.e., rigidity, is provided by attaching a pin holder 40 to one of the rods, such as the pin holder shown in
[0074] In another embodiment, the steps of the surgical technique are the same as those used to create the surgical access portal defined by the instrument and blade shown in
[0075] In yet another embodiment, a surgical technique involves the same steps as described above up to and including advancement and positioning of composite blade 360, although once composite blade 360 is in position over a vertebral body within the patient, two double pin blades 60 are used to complete the requisite retraction to create the surgical access portal, instead of the retraction instrument. Here, each double pin blade 60 is inserted into the surgical access portal using an antero-lateral approach so that respective blades 60 are positioned over a vertebral body, as shown in
[0076] Once double pin blades 60 are in position, they may be manually held in place for the surgical procedure or they may be externally fixed using a rigid arm (not shown). Optionally, one or two bone pins 90A, 90B may be disposed within grooves on blade 60 and advanced into a vertebral body below the blade 60 to provide additional support for the surgical access portal. This may be done for one or both blades. In the embodiment shown in
[0077] Additionally, in other examples of the surgical technique, a light emitting structure, such as a fiber optic light bar (not shown), may be clipped onto upper and lower central recess 76A, 77 of double pin blade 60 and slid down to a desired location on the blade to direct light into the surgical access portal. The blade may further include a preset stop with a highly reflective surface. In this manner, once a distal end of the light bar is positioned at the preset stop, light may be directed into a working area of the surgical portal. Similarly, a light bar or light pipe may be inserted through a cannulation in the rod and advanced to a preset stop at an end of the cannulation on a side of the rod, the preset stop directing light into the portal. The light emitting structure may also be clipped to blade 260 in the same manner. Other lighting technologies contemplated for inclusion on the rods of the retraction instrument and the blades of the present disclosure include those described in WO2019/036048, the disclosure of which is hereby incorporated by reference herein in its entirety.
[0078] In yet another embodiment, the surgical method employs composite blade 760, shown in
[0079] The surgical method may be varied in many ways. Various combinations of the blades disclosed herein, including blades 60, 160, 260, 360, 460, 560, 660 and 760 may be used to create a surgical access portal to access the spine. Any number of these blades may be used in combination with any retraction instrument 10, 110, 210. When blades 160, 260, 460, 560, 660, 760 are used to create a surgical portal, the curved distal end of the applicable blade may also mate with an intervertebral disc or vertebral body to obtain increased surface area contact between the blade and the vertebral surface. Additionally, the rods for each of the retraction instruments may be removed and used interchangeably with lateral trans-psoas retractor systems, such as those described in the '228 Publication.
[0080] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. 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 disclosure as defined by the appended claims.