ULTRASONIC SPINAL SURGERY METHOD AND ASSOCIATED SURGICAL INSTRUMENT
20220370094 · 2022-11-24
Inventors
- Nicholas Theodore (Ruxton, MD, US)
- Dan Voic (Cedar Grove, NJ, US)
- Paul MIKUS (Miami, FL, US)
- Christopher BALLOR (Chesterfield, MI, US)
- Sharon KLUGEWICZ (Rockville Centre, NY, US)
Cpc classification
A61B17/320092
HUMAN NECESSITIES
A61B17/320068
HUMAN NECESSITIES
International classification
Abstract
An elongate ultrasonic dissector-shaver probe has a laterally enlarged head extending distally and transversely from a distal end of a shaft and provided with sets of spiraling ribs. In a disc space preparation procedure, the probe is inserted into a spinal disc between two vertebral endplates, ultrasonic vibratory energy is conducted into the probe, and the probe is manipulated to move the laterally enlarged head in three spatial directions within the spinal disc to thereby disrupt and shred the spinal disc material into fragments extracted from the space, in part by suction and in part by using forceps to pull spinal disc fragments from the operative space or surgical site between the vertebral endplates.
Claims
1. A spinal surgery method comprising: providing an ultrasonic probe including an elongate shaft and a laterally enlarged head at a distal end of said shaft; conducting ultrasonic vibratory energy into said ultrasonic probe to generate a standing wave therein; during the conducting of ultrasonic vibratory energy, inserting a distal end of an ultrasonic probe into a spinal disc between two vertebral endplates; thereafter, also during the conducting of ultrasonic vibratory energy, manipulating said ultrasonic probe to move said laterally enlarged head alternately in a distal and a proximal direction. alternately towards left and right within said spinal disc, and alternately towards and away from the vertebral end plate surfaces to thereby disrupt and shred at least a portion of said spinal disc into fragments exhibiting a range of different sizes including segments too large to aspirate from a space occupied by said spinal disc between said vertebral endplates; and extracting said fragments from said space, the extracting of said fragments including using forceps or graspers to pull at least some of said segments from said space.
2. The spinal surgery method defined in claim 1 wherein said laterally enlarged head includes at least one convexly arcuate edge disposed in a major plane orthogonal to a longitudinal axis of said shaft, said laterally enlarged head having largest dimensions orthogonal to said longitudinal axis located in said major plane, said laterally enlarged head tapering down in a proximal direction from said major plane to said shaft, said laterally enlarged head tapering down in a distal direction from said major plane to a free end opposite said shaft.
3. The spinal surgery method defined in claim 2 wherein said at least one convexly arcuate edge is one of two opposed mirror-symmetric convex edge segments disposed in said major plane, further comprising, during the conducting of ultrasonic vibratory energy, manipulating said ultrasonic probe to engage first one and then another of said vertebral endplates with respective ones of said two opposed mirror-symmetric convex edge segments to thereby remove disc material from surfaces of both of said vertebral endplates.
4. The spinal surgery method defined in claim 2, further comprising, during the conducting of ultrasonic vibratory energy, manipulating said ultrasonic probe to engage at least one of said vertebral endplates with said at least one convexly arcuate edge to thereby remove disc material from a surface of said at least one of said vertebral endplates facing said space.
5. The spinal surgery method defined in claim 1 wherein the inserting of the distal end of the ultrasonic probe into the spinal disc includes, during the conducting of ultrasonic vibratory energy, manipulating the ultrasonic probe to perform an annulotomy on the spinal disc.
6. The spinal surgery method defined in claim 5, further comprising operating said ultrasonic instrument, prior to the inserting of the distal end of the ultrasonic probe into the spinal disc and prior to the manipulating of the ultrasonic probe to perform the annulotomy, using said ultrasonic instrument to remove osteophytes from one or both of the vertebral endplates.
7. The spinal surgery method defined in claim 1 wherein the manipulating of said ultrasonic probe includes manipulating said ultrasonic probe to move said laterally enlarged head alternately towards and away from one of said vertebral endplates so as to trap disc material between said laterally enlarged probe head and said one of said vertebral endplates, whereby the trapped disc material is severed.
8. The spinal surgery method defined in claim 1, further comprising, during the conducting of ultrasonic vibratory energy, manipulating said ultrasonic probe to engage said vertebral endplates with said laterally enlarged head and thereby remove disc material soft tissue and cartilage from surfaces of said vertebral endplates.
9. The spinal surgery method defined in claim 1 wherein said range extends from less than one millimeter to more than one centimeter.
10. The spinal surgery method defined in claim 1 wherein the extracting of said fragments includes aspirating some of said fragments from said space.
11. The spinal surgery method defined in claim 1 wherein said forceps is a Pituitary Rongeurs.
12. An ultrasonic probe comprising: an elongate shaft; a connector at a proximal end of said shaft for operatively coupling said shaft to a source of ultrasonic vibratory energy to generate a mechanical standing wave in the probe; and a laterally enlarged head at a distal end of said shaft, said laterally enlarged head including at least one convexly arcuate edge disposed in a major plane oriented orthogonal to a longitudinal axis of said shaft, said laterally enlarged head being larger in one direction than another direction oriented at an angle thereto in said major plane, said laterally enlarged head tapering down in a proximal direction from said major plane to said shaft, said laterally enlarged head tapering down in a distal direction from said major plane to a free end of the probe opposite said shaft.
13. The ultrasonic probe defined in claim 12 wherein said at least one convexly arcuate edge is one of two opposed mirror-symmetric convex edge segments disposed in said major plane.
14. The ultrasonic probe defined in claim 13 wherein said two opposed mirror-symmetric convex edge elements lie along an ellipse.
15. The ultrasonic probe defined in claim 14 wherein said laterally enlarged head includes a distal end surface and a proximal end surface each in the form of a cross-sectionally elliptical cone, each of said distal end surface and said proximal end surface being contiguous with both of said two opposed mirror-symmetric convex edge segments.
16. The ultrasonic probe defined in claim 15 wherein said two opposed mirror-symmetric convex edge segments, said distal end surface and said proximal end surface are textured or knurled.
17. The ultrasonic probe defined in claim 12 wherein said shaft has a channel or lumen, said laterally enlarged head having an aperture on a distal side, said aperture communicating with said channel or lumen.
18. The ultrasonic probe defined in claim 12 wherein said laterally enlarged head is formed with spiraling ribs.
19. The ultrasonic probe defined in claim 12 wherein said laterally enlarged head has an ellipsoidal or ovoid form.
20. The ultrasonic probe defined in claim 12 wherein said laterally enlarged head is textured or knurled on an outer side.
21. The ultrasonic probe defined in claim 12 wherein said laterally enlarged head includes a distal end surface and a proximal end surface each having an at least approximately elliptical cross-section, said shaft having a channel or lumen, said laterally enlarged head having an aperture on a distal side, said aperture communicating with said channel or lumen.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DEFINITIONS
[0050] The term “discectomy” is used herein to designate a procedure involving removal of spinal disc material from a spinal disc between two vertebrae or vertebral endplates. The disc material being removed may be small, for instance, to prevent impingement of a spinal disc on the spinal cord. Alternatively, a discectomy may entail removal of a substantial portion of a disc, such as the nucleus pulposus, or an entire disc including both the pulposus and the annulus fibrosus.
[0051] A “disc space preparation” procedure pursuant to the present disclosure includes not only a substantial discectomy, or removal of a substantial portion or all of a spinal disc, but also contemplates preparation of the adjacent vertebral end faces so that a prosthesis inserted into the disc space between the two vertebral endplates satisfactorily adheres to the endplates. The preparation of the disc space includes cleaning or removal of disc material, soft tissue and cartilage from the vertebral end faces, thereby increasing the likelihood of proper adhesion of a prosthesis to the vertebrae. The cleaning of the endplate faces or surfaces typically results in possibly undesirable but unavoidable removal of osseous tissue. Vertebral osteophytes may be removed in the process. The use of an ultrasonic probe to clean vertebral endplates is advantageous in that little force need be applied to the vertebrae. Thus greater control is possible, enabling a surgeon to remove just enough disc material and cartilage to enable fusion of a prosthesis with the bony tissue, without unnecessarily increasing the chances of the prosthesis breaking through and rupturing the vertebral end face.
[0052] The term “probe” or “ultrasonic probe” is used herein to designate an elongate metallic tool designed to carry an ultrasonic standing wave of a predetermined ultrasonic frequency, so that an operative surface or edge at the distal end of the probe entertains a maximal movement amplitude at the predetermined ultrasonic frequency and a correspondingly maximized transmission of ultrasonic vibratory energy to a target organic tissue within a patient.
[0053] The term “major plane” is used herein to describe the plane transverse to an ultrasonic probe's longitudinal axis wherein the probe head is widest and thus has its greatest transverse dimension. The probe head preferably has a cutting edge, and more preferably two opposed cutting edges, disposed in the major (transverse) plane.
[0054] The term “laterally enlarged” is used herein to describe a probe head that is wider than the distal end of the probe shaft. The probe head projects to the side beyond the shaft, at least in part facilitating contact with vertebral endplate faces.
DETAILED DESCRIPTION
[0055]
[0056] Dissector-shaver probe 10 includes a threaded coupling 26 connectable to a piezoelectric or magnetostrictive transducer 28 in a handle or housing 30 that in turn is operatively connectable to an ultrasonic waveform generator 32. Transducer 28 converts an applied or incoming electrical waveform form generator 32 into a mechanical ultrasonic vibration that produces a standing waveform in probe 10.
[0057] As shown in
[0058] As illustrated in
[0059] Circular edge 20 of head 14 includes a pair of opposed convexly arcuate edge segments 44 and 46 that face major surfaces 48 and 50 of respective vertebral endplates V1 and V2. Circular edge 20 and accordingly convexly arcuate edge segments 44 and 46 lie in and define a major plane 52 of head 14 oriented orthogonally to a longitudinal axis 54 of shaft 12. The term “major plane” is used herein to designate a plane in which head 14 (114, 214, 314, 414) has a larger cross-section than in all other planes parallel to the major plane. Flattened probe heads typically have one major plane perpendicular to the longitudinal axis of the probe and another major plane containing the probe or shaft axis.
[0060] After extraction of the disrupted disc SD or a substantial portion thereof, in part through pulling of large disc fragments 40 out from space S by graspers 42 and in part through aspiration of particulate spinal disc material 39 by means of a suction cannula 56 connected to a suction source 58 (
[0061] Probe 10 works efficaciously in disrupting, shredding and tearing apart the material of spinal disc SD. While probe head 14 functions tolerably well in cleaning and roughening surfaces 48 and 50 of vertebral endplates V1 and V2, a different geometry is optimal for that purpose.
[0062] Arcuate edge segments 144 and 146 are optimally elongated to fit along concave vertebral end plate surfaces 48 and 50, matching curvatures thereof, thus facilitating cleaning of the endplate surfaces after at least substantial removal of the body of the respective spinal disc SD as described hereinabove. Edge segments 144 and 146 constitute two opposed mirror-symmetric knurled abrading edges disposed in major plane MP.sub.1 of head 114. During the conducting of ultrasonic vibratory energy into the ultrasonic probe 110, the probe is manipulated to engage first one and then another of the vertebral endplates V1, V2 with edge segments 144, 146, respectively, with probe 110 being moved alternately back and forth along the vertebral surfaces 48 and 50 in a distal and proximal direction as indicated by arrows 60 and 62 in
[0063] Head 114 has its largest transverse dimensions d.sub.1 and d.sub.2 in the major plane MP′, respectively along a major axis and a minor axis (not separately designated) both orthogonal to the longitudinal axis 154 of shaft 112. Edges 20 and 120 of probe heads 14 and 114 are formed as intersections or joints between two surfaces 44, 46 and 144, 146 of different inclinations.
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[0065] Heads 214 and 314 are both oblate or flattened in a direction transverse to respective shaft axes 254 and 354. Thus each head 214 and 314, like head 114, exhibits an oval or elliptical transverse cross-section in all planes perpendicular to the respective longitudinal shaft axis 254, 354. Each such laterally enlarged head 114, 214, 314 tapers down in a proximal direction from the plane of the respective oval edge 120, 220, 320 to the respective shaft 112, 212, 312 and in a distal direction from the oval edge to a free end opposite the shaft.
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[0067] The present invention mainly contemplates that shafts 12, 112, 212, 312, 412 are formed with respective channels or lumens 64, 164, 264, 364, 464 that communicate with a pressurized supply 66 (
[0068] Disc fragments 38, 39, 40 have sizes in a range from less than one millimeter to more than one centimeter. The larger disc fragments 40 can be as long as two or three centimeters with a width of a few millimeters. While such large fragments are extracted via graspers or forceps 42, smaller, particulate, fragments or particles 39 can be aspirated from the surgical site or operative space S by suction source 58 via cannula 56.
[0069] Edges 120, 220, 320 each incorporate two opposed mirror-symmetric convex edge segments 144, 146 and 244, 246, and 344, 346 disposed in the major plane of the head 114, 214, 314. The two opposed mirror-symmetric convex edge elements 144, 146 and 244, 246, and 344, 346 may each lie along an ellipse. Where the two opposed mirror-symmetric convex edge elements 144, 146 and 244, 246, and 344, 346 both lie along the same ellipse, the respective distal end surface 116, 216, 316 and proximal end surface 118, 218, 318 each take the form of a truncated cross-sectionally elliptical cone, each distal end surface and proximal end surface being contiguous with both of the two opposed mirror-symmetric convex edge segments 144, 146 and 244, 246, and 344, 346.
[0070] After removal of spinal disc SD as described above, vertebral endplates V1 and V2 may be fused to one another. Alternatively, a disc prosthesis or graft may be inserted between the two vertebrae V1, V2. The ultrasonically vibrating of the head 14, 114, 214, 314, 414 during the contacting of the vertebral endplates V1, V2 (arrows 60, 62) serves in part to provide the opposing faces 48, 50 with textured surfaces free of disc material and cartilaginous tissue. The leveling and texturing of the vertebral surfaces opens access to the blood vessels in the vertebrae and facilitates subsequent growth and attachment of the bone to the material of a disc prosthesis or graft.
[0071] Channel or lumen 64, 164, 264, 364, 464 and aperture 68, 168, 268, 368, 468 in probe head 14, 114, 214, 314, 414 communicating therewith are used to convey irrigant to the probe head and to ambient or adjacent tissues during the contacting of the opposing faces 48, 50 of the vertebral endplates V1, V2. In addition, on some occasions, it may be advantageous to use the channel or lumen 64, 164, 264, 364, 464 to aspirate particulate matter 39 formed during the ultrasonic disruption process. The aspirating of particulate disc material either by cannula 56 or probe 10, 110, 210, 310, 410 may occur in part during the generating of the standing wave in the probe. Alternatively, the vibrating of the tool may be momentarily interrupted during the aspiration process. Aspiration and irrigation may be applied in alternation, with the irrigation serving (i) to cool the probe during ultrasonic energization, (ii) to render particulate material into a slurry for extraction via suction and (iii) to dislodge larger fragment than may become wedged into the distal end of the channel or lumen, exemplarily in the probe head.
[0072] Suction source 58 includes a particulates trap and supplies irrigant under pressure to channel or lumen 64, 164, 264, 364, 464 via a manifold 70 (
[0073] A spinal surgical method pursuant to the present invention may rely on and incorporate conventional open surgery or minimally invasive procedures for obtaining access to a target disc space. The surgical method of the present invention proceeds in the same way regardless of the access method used. In addition, the present invention may be used together with robotics and existing navigation systems to facilitate control of instrument movements relative to patient tissue structures. The navigation systems include scanners or trackers and associated computer software that may be used to record 3D structural data of a patient's spinal tissues prior to surgery. The systems track the locations of surgical instruments during surgery and particularly the locations of end effectors or operative tips of the instruments within the patients. A probe may be provided with fiducial markings or electromagnetic wave transmitters or other location-encoding devices to facilitate computer tracking of probe head location and optionally probe orientation relative to spinal structures, and to enable imaging on a computer monitor of the probe together with and in relation to spinal structures. Exemplary navigation systems include Medtronic's Stealth Station S8 EM Navigation System and Stryker's NAV3i Platform. Such systems can be and are used with a variety of different surgical instruments to track the instruments, enhancing surgical accuracy and increasing patient safety.
[0074] The invention effectuates disc disruption and fragmentation primarily through mechanical action of the probe through the disc material. Disc material is highly elastic and frequently impervious to ultrasonic ablation. However, the present method combines the application of ultrasonic vibratory energy with larger-scale mechanical motion that provides a radically improvement over ultrasound and large scale mechanical motion individually. The trapping of disc material between the probe head and a vertebral endplate facilitates selective disruption of elastic disc material. A secondary means of disc fragmentation provided by the present invention is ultrasonic cavitation or sonication, which is made possible with the introduction of liquid irrigant into the disc space. A further technique comprises irradiating a target disc with radio-frequency electromagnetic energy prior to and during the energization and movement of the ultrasonic probe within the disc and/or along the vertebral endplate faces. The radiation reduces the elasticity of the disc material and improves disc fragmentation and vertebral cleaning.
[0075] It is to be noted that an ultrasonic probe 12, 112, 212, 312, 412 as disclosed herein provides tactile feedback so that the operating surgeon can sense immediately when the probe head 14, 114, 214, 314, 414 comes into contact with a surface of a vertebral endplate V1, V2. This feedback prompts a change in force application and possibly direction of probe movement and facilitates cleaning of the endplate surfaces without unduly abrading and ablating bony tissue from the endplates V1, V2.
[0076] A set of surgical instruments peculiar to the disc space preparation procedure described herein may be combined as a kit, including dissector shaver 12, 112, 212, 312, and/or 412, one or more suction cannulas 56, and one or more graspers or forceps 42. These may be packaged together in a single container or otherwise sold together.
[0077] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof