EXPANDABLE SPINAL IMPLANTS AND INSTRUMENTS AND METHODS FOR IMPLANT DELIVERY AND DEPLOYMENT
20190365544 ยท 2019-12-05
Inventors
Cpc classification
A61F2/4455
HUMAN NECESSITIES
A61F2002/30131
HUMAN NECESSITIES
A61F2002/30405
HUMAN NECESSITIES
International classification
Abstract
Novel implants, instruments and surgical techniques are provided for manipulating a spinal disc space in order to one or more of: optimize disc space preparation; optimize the positioning of implants within the disc space; achieve and maintain distraction during interbody placement; and provide sagittal balance during fusion.
Claims
1. A modular spinal implant, comprising: a transverse component having a generally convex top surface, a bottom surface, and an emplacement; and a sagittal component having a generally wedge-shaped conformation defined by elongate sides and a wide base that tapers toward a tip portion, and a coupling surface at the base, wherein the coupling surface of the sagittal component and the emplacement of the transverse component are arranged and disposed to engaged to form an attached configuration between the transverse component and the sagittal component, with the tip portion of the sagittal component extending from the bottom surface of the transverse component.
2. The modular spinal implant of claim 1, wherein the sagittal component includes a wedge member and a locking member, the locking member attaching to the wedge member in a locked configuration to retain the transverse component and the sagittal component in the attached configuration.
3. The modular spinal implant of claim 2, wherein either: one of the wedge member and the locking member includes a gear rack and the other of the wedge member and the locking member includes a ratchet; or the wedge member includes an internal threaded surface and the locking member includes an external threaded surface.
4. The modular spinal implant of claim 2, wherein the wedge member includes a slot that opens at the tip portion and extends to the coupling surface disposed, and a first prong and a second prong on either side of the slot and extending away from the coupling surface.
5. The modular spinal implant of claim 4, wherein the slot that extends to the coupling surface is generally U shaped.
6. The modular spinal implant of claim 4, wherein the locking member is arranged and disposed to occupy and substantially fill the slot in the locked configuration.
7. The modular spinal implant of claim 4, wherein the transverse component includes a first aperture and a second aperture adjacent to the emplacement, the first aperture being arranged and disposed to receive the first prong and the second aperture being arranged and disposed to receive the second prong in the attached configuration such that the coupling surface of the sagittal component contacts the emplacement of the transverse component.
8. The modular spinal implant of claim 7, wherein the first aperture and the second aperture extend from the emplacement to a lateral surface of the transverse component.
9. The modular spinal implant of claim 7, wherein the generally convex top surface of the transverse component includes a recess arranged and disposed to engage the base of the slot in the attached configuration.
10. The modular spinal implant of claim 1, wherein the sagittal component and the transverse component are arranged and disposed such that in the attached configuration a center line of the sagittal component extending from the bottom surface of the transverse component to the tip portion of the sagittal component is oblique relative to the bottom surface.
11. The modular spinal implant of claim 1, wherein the coupling surface of the sagittal component is on the base and includes an attachment feature that is complimentary with an attachment feature on the bottom surface of the transverse
12. A modular spinal implant of claim 1, wherein the transverse component has a length dimension, a width dimension and a depth dimension, and wherein the length dimension is greater than the width dimension which is greater than the depth dimension.
13. A modular spinal implant of claim 12, wherein the transverse component includes a first aperture and a second aperture adjacent to the emplacement to define two planar members, wherein the apertures and the emplacement are either centered or off center along the length dimension.
14. A modular spinal implant of claim 12, wherein the transverse component has a generally arcuate shape.
15. A modular spinal implant of claim 1, the transverse component having a length dimension, a width dimension and a depth dimension, wherein the length dimension is greater than the width dimension which is greater than the depth dimension, and having two planar members defined by apertures adjacent to the emplacement, and sagittal component including a wedge member having a slot that opens at the tip portion and extends to the coupling surface to define a first prong and a second prong on either side of the slot and extending away from the coupling surface, wherein the slot has a width dimension between the prongs that is larger than the depth dimension of the transverse component and is smaller than the width dimension of the transverse component 260, wherein, the transverse component is adapted for insertion into the slot of the sagittal component lengthwise with its length dimension parallel with the prongs, and then rotated by about 90 degrees so that its length dimension is perpendicular to the prongs and its width dimension is parallel with the prongs, and then rotated again by about 90 degrees so that its depth dimension is parallel with the prongs such that the transverse component is oriented generally orthogonally with respect to the sagittal component.
16. A method for surgically modifying a spine with a modular spinal implant, comprising: inserting a transverse component into a distracted disc space of a spinal column, the transverse component having a generally convex top surface, a bottom surface, and an emplacement; inserting a sagittal component into the distracted disc space, the sagittal component having a generally wedge-shaped conformation defined by elongate sides and a wide base that tapers toward a tip portion, and a coupling surface; and attaching the sagittal component to the transverse component in the distracted disc space to form the modular spinal implant in an attached configuration with the coupling surface of the sagittal component engaged to the emplacement of the transverse component, and with the sagittal component extending from the bottom surface of the transverse component with the tip portion of the sagittal component distal from the bottom surface of the transverse component.
17. The method of claim 16, wherein the sagittal component includes wedge member and a locking member, and attaching the sagittal component to the transverse component includes attaching the locking member to the wedge member to form a locked configuration retaining the transverse component and the sagittal component in the attached configuration.
18. The method of claim 17, wherein the wedge member is inserted into the distracted disc space prior to the transverse component being inserted into the distracted disc space.
19. The method of claim 18, wherein the locking member is inserted into the distracted disc space following the transverse component being inserted into the distracted disc space.
20. The method of claim 19, wherein: the transverse component includes a first aperture and a second aperture adjacent to the emplacement; the wedge member includes a slot that opens at the tip portion and extends to a base of the slot, and a first prong and a second prong on either side of the slot; and attaching the sagittal component to the transverse component includes inserting the first prong into the first aperture and the second prong into the second aperture such that the coupling surface of the sagittal component contacts the emplacement of the transverse component.
21. The method of claim 20, wherein the first aperture and the second aperture extend from the emplacement to a lateral surface of the transverse component, and inserting the first prong into the first aperture and the second prong into the second aperture includes rotating the transverse component relative to the wedge member and then inserting the locking member into the slot.
22. The method of claim 21 wherein inserting the locking member into the slot occupies and substantially fills the slot.
23. The method of claim 21, wherein inserting the first prong into the first aperture and the second prong into the second aperture includes engaging the base of the slot with a recess disposed in the generally convex top surface of the transverse component.
24. The method of claim 16, wherein either: one of the wedge member and the locking member includes a gear rack and the other of the wedge member and the locking member includes a ratchet, and attaching the locking member to the wedge member includes engaging the ratchet and the gear rack; or the wedge member includes an internal threaded surface and the locking member includes an external threaded surface, and attaching the locking member to the wedge member includes engaging the external threaded surface with the internal threaded surface.
25. A method for surgically preparing a spinal disc space, comprising the steps: (i) directing at least a first elongate distractor blade having a proximal end and a distal end comprising a flared paddle into a spinal disc space and between adjacent vertebral endplates, the flared paddle of the distractor blade being parallel to the endplates; (ii) advancing the flared paddle into contact with an anterior annulus of the spinal disc space; (iii) actuating the distractor blade by rotation of its proximal end by about 90 degrees whereby the flared paddle is oriented rotated to be approximately perpendicular to the vertebral endplates; (iv) optionally introducing at least a second elongate distractor blade adjacent to the first distractor blade, and repeating each of steps (i), (ii) and (iii), the at least second distractor blade having a flared paddle that is one of dimensionally larger, equivalent to or smaller than the flared paddle of the first distractor; (v) optionally repeating step (vi) with one or more additional elongate distractor blades, each one or more additional elongate distractor blades having a flared paddle that one of dimensionally larger, equivalent to or smaller than the flared paddle of a previously inserted elongate distractor blade; (vi) withdrawing each of the one or more of the elongate distractor blades; (vii) optionally, repeating the steps (i)-(v), one or more times.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Features and advantages of the general inventive concepts will become apparent from the following description made with reference to the accompanying drawings, including drawings represented herein in the attached set of figures, of which the following is a brief description:
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[0052] This disclosure describes exemplary embodiments in accordance with the general inventive concepts and is not intended to limit the scope of the invention in any way. Indeed, the invention as described in the specification is broader than and unlimited by the exemplary embodiments set forth herein, and the terms used herein have their full ordinary meaning.
DESCRIPTION
[0053] In accordance with the various embodiments, techniques, instruments and implants are provided which can be used individually or together to facilitate the preparation of a spinal disc space for receiving an implant and enhancing the achievement of correction of sagittal balance within the spine. In some embodiments, the techniques enable enhanced preparation of the disc space. In other embodiments, the instruments provide features that are improved over the art and facilitate enhanced disc space preparation. And in yet other embodiments, the implants are adapted for implantation, particularly, though not exclusively through minimally invasive approaches and in situ assembly.
[0054] Technique and Instruments for Disc Preparation
[0055] In some embodiments, provided here is a technique that may be used, particularly during a TLIF procedure, for preparing the disc space for placement of an implant so as to optimize distraction of the disc space and disruption of the contralateral (in some cases, anterior) annulus. According to the technique, a conventional Collis-type Interbody retractor/distractor (essentially an elongate handle at its proximal end and having at its distal end a wide blade with a generally planar surface) is selected, whereby one or more such distractors are passed into the disc space and advanced toward the anterior annulus under X-ray (fluoroscopy) then rotated by 90 degrees to break calcifications and release the annulus. According to the technique, the interspace may be opened to provide enhanced distraction for implanting interbody devices to recreate the anatomically relevant lordosis.
[0056] Referring now to the drawings,
[0057] Referring now to
[0058] As schematically depicted in
[0059] As is further described herein below, a disclosed embodiment of an articulating paddle distractor according to the disclosure enables a similar type of motion to disrupt the annulus using an articulating embodiment of the distractor to further enhance penetration into the disc space along the anterior annulus. Use of this alternate distractor is particularly advantageous in that it avoids the need for rotation of a blade against the vertebral endplates, which can cause undesirable damage to the endplate surface and possibly induce fracture. Further description of the paddle distractor follows.
[0060] Referring again to the drawings, as shown in
[0061] In the various embodiments, the flared paddle 120 has a width dimension in a first plane 121 that is generally the same as or slightly greater than the width dimension of the elongate handle 110 and/or the grip 111, and a length dimension in a second plane 122 that is oriented 90 degrees to the first plane that is greater than the width dimension in the first plane 121. The flared paddle 120 also has a height dimension 125 as measured from the distal most end of the flared base to its point of attachment 130 to the handle. In some embodiments, the height dimension 125 is less than or equal to the width dimension 124, and in other embodiments, the height dimension 125 is greater than the width dimension 124.
[0062] In some embodiments, the flared paddle 120 may be generally block shaped where its width in one or both of the first and second planes does not vary along the height dimension, such as is shown in the depicted embodiments of
[0063] Referring again to
[0064] Implants
[0065] Provided are implants that can be assembled in situ, particularly in the context of a minimally invasive procedure, such as TLIF. Referring to
[0066] Referring now to
[0067] Referring again to
[0068] Referring now to
[0069] Of course, in alternate embodiments, the shapes of each member may be different from one another and their relative dimensions including width and thickness may vary from those as shown in the drawings. Moreover, though the transverse component is depicted as having a curved upper surface and a curved lower surface, and an overall arcuate shape, it will be appreciated that the shape may be flat and planar or may be flat with a convex upper surface. Further, while the emplacement is defined by apertures that extend towards the middle of the component from its sides (lateral edges) and are generally slot shaped, it will be appreciated that the apertures may be other than slot shaped. Further still, the emplacement may be offset from the center of the length dimension, as depicted in the embodiment shown in the drawings, or may be centered therein. And the emplacement may have a cross section that is generally circular (as depicted in the drawings), or square, rectangular, triangular, and the like.
[0070] Referring again to the drawings,
[0071] In an exemplary embodiment, as is generally depicted sequentially in
[0072] Thus, the implant 200 is designed so that it may be inserted piece by piece and assembled within a distracted disc space by first inserting the sagittal component 220 into the space with the elongate tool, the wider flat portion of the sagittal component 220 insertable in a first orientation into the disc space with its planar surfaces parallel to the vertebral endplates and directed toward the anterior wall where is it rotated 90 degrees by actuation of the inserter tool. Referring now to
[0073] Of course, it will be appreciated that the implant assembly 200 may be assembled outside the disc space and subsequently inserted therein. Further, while the above description contemplates that that implant assembly 200 is positioned in the disc space with the transverse component 260 oriented toward the anterior aspect of the disc space, in alternate embodiments, the implant assembly 200 may be positioned in alternate orientations.
[0074] Embodiments of the present invention are not limited to use in a posterior or transforaminal approach for spinal surgery and may be adapted for uses in other spinal surgical orientations by other means of access within a disc space.
[0075] This disclosure describes exemplary embodiments in accordance with the general inventive concepts and is not intended to limit the scope of the invention in any way. Indeed, the invention as described in the specification is broader than and unlimited by the exemplary embodiments set forth herein, and the terms used herein have their full ordinary meaning.
[0076] The general inventive concepts may be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the general inventive concepts to those skilled in the art.
[0077] As used herein, the singular forms a, an, and the are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term proximal as used in connection with any object refers to the portion of the object that is closest to the operator of the object (or some other stated reference point), and the term distal refers to the portion of the object that is farthest from the operator of the object (or some other stated reference point). The term operator means and refers to any professional or paraprofessional who delivers clinical care to a medical patient, particularly in connection with the delivery of care.
[0078] Anatomical references as used herein are intended to have the standard meaning for such terms as understood in the medical community. For example, the application may include reference to the following terms: cephalad, cranial and superior indicate a direction toward the head, and the terms caudad and inferior indicate a direction toward the feet. Likewise, the terms dorsal and posterior indicate a direction toward the back, and the terms ventral and anterior indicate a direction toward the front. And the term lateral indicates a direction toward a side of the patient. The term medial indicates a direction toward the mid line of the patient, and away from the side, the term ipsalateral indicates a direction toward a side that is proximal to the operator or the object being referenced, and the term contralateral indicates a direction toward a side that is distal to the operator or the object being referenced.
[0079] More specifically with respect to the directional movement of an implant according to the methods of the disclosure, sideways refers to the general direction of movement within the disc space between the endplates from the position of the inserted instruments toward one or the other of the contralateral and ipsilateral portions of the disc space. In the case of a TLIF procedure, such sideways motion will generally be in a medial direction relative to the disc space. Though in other types of surgical access, particularly within the spine, sideways movement may be either medial or lateral relative to the disc space, and in other surgical contexts sideways is away from the initial position of the implant. Further, with respect to the movement of an implant by action of the surgical instruments, the movement may also be rotational, wherein the action of the instruments directs the implant sideways and also in a rotational or pivotal motion. More generally, any and all terms providing spatial references to anatomical features shall have meaning that is customary in the art.
[0080] Unless otherwise indicated, all numbers expressing quantities, properties, and so forth as used in the specification, drawings and claims are to be understood as being modified in all instances by the term about. Accordingly, unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the suitable properties desired in embodiments of the present invention. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the general inventive concepts are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements.
[0081] References to visualization using radiography as may be described in the exemplary techniques herein are merely representative of the options for the operator to visualize the surgical field and the patient in one of many available modalities. It will be understood by one of ordinary skill in the art that alternate devices and alternate modalities of visualization may be employed depending on the availability in the operating room, the preferences of the operator and other factors relating to exposure limits. While confirmation of instrument placement in the course of the technique is appropriate, the frequency and timing relative to the sequence of steps in the technique may be varied and the description herein is not intended to be limiting. Accordingly, more or fewer images, from more or fewer perspectives, may be collected.
[0082] One of ordinary skill will appreciate that references to positions in the body are merely representative for a particular surgical approach. Further, all references herein are made in the context of the representative images shown in the drawings. Fewer or additional instruments, including generic instruments, may be used according to the preference of the operator. Moreover, references herein to specific instruments are not intended to be limiting in terms of the options for use of other instruments where generic options are available, or according to the preference of the operator.
[0083] While the disclosed embodiments have been described and depicted in the drawings in the context of the human spine, it should be understood by one of ordinary skill that all or various aspects of the embodiments hereof may be used in in connection with other species and within any species on other parts of the body where deep access within the tissue is desirable.
[0084] While various inventive aspects, concepts and features of the general inventive concepts are described and illustrated herein in the context of various exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the general inventive concepts. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions (such as alternative materials, structures, configurations, methods, devices and components, alternatives as to form, fit and function, and so on) may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed.
[0085] Those skilled in the art may readily adopt one or more of the inventive aspects, concepts and features into additional embodiments and uses within the scope of the general inventive concepts, even if such embodiments are not expressly disclosed herein. Additionally, even though some features, concepts and aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure; however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.
[0086] Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated.