(12) United States Patent
`Hamada
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8.236,006 B2
`Aug. 7, 2012
`
`USOO823 6006B2
`
`(54) ONE STEP ENTRY PEDICULAR
`PREPARATION DEVICE AND DISC ACCESS
`SYSTEM
`
`(75) Inventor: James S. Hamada, Torrance, CA (US)
`(73) Assignee: Life Spine, Inc., Hoffman Estates, IL
`(US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 497 days.
`
`(21) Appl. No.: 12/321,311
`(22) Filed:
`Jan. 15, 2009
`O
`O
`Publication Dat
`O DO
`US 2009/O1871.94 A1
`Jul. 23, 2009
`
`65
`(65)
`
`P
`
`Related U.S. Application Data
`(63) Continuation-in-part of application No. 12/009,496,
`filed on Jan. 17, 2008, now Pat. No. 8,075,579.
`
`(51) Int. Cl.
`(2006.01)
`A6B 7/58
`(52) U.S. Cl. ....................................................... 606/104
`(58) Field of Classification Search .................. 600/426,
`600/427, 429: 606/279, 292, 266, 312,318,
`606/916, 79, 60, 61, 63
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`5,171,279 A * 12/1992 Mathews ...................... 128/898
`6,175,758 B1
`1/2001 Kambin
`
`
`
`606/61
`
`2005. SR i58.
`Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`2006/0079903 A1
`4/2006 Wong
`2007, OO16219 A1
`1/2007 Levine
`2008/0086140 A1
`4, 2008 Wolf
`2009,0254131 A1 10, 2009 ROh
`FOREIGN PATENT DOCUMENTS
`WO WO 2009/09 1616 A3
`T 2009
`OTHER PUBLICATIONS
`Written Opinion of the International Searching Authority for PCT/
`US2009/000393, dated Aug. 27, 2009, 6 pages.
`US Office Action for U.S. Appl. No. 12009,496, mailing date Apr.
`20, 2011, 16 pages.
`k .
`cited by examiner
`Primary Examiner — Eduardo C Robert
`- - -
`-
`Assistant Examiner — Ann Schillinger
`(74) Attorney, Agent, or Firm — Foley & Lardner LLP
`
`ABSTRACT
`(57)
`A one step entry pedicular preparation device works well with
`Minimal Invasive Spine Surgery (MISS) to facilitating such
`approach. A related intervertebral disc access system and
`pedicle screw compatible with the systems is also illustrated.
`The systems include a manipulator having a bar handle and
`main body with main barrel bore a pedicle dart having a
`proximal tip end and a second distal open end selectably
`attachable to the manipulator using a variety of interconnect
`configurations, both of which work in conjunction with a
`guide pin. The pedicle darts can be made of any material,
`disposable or re-usable and can be utilized for a variety of
`purposes, including bone structure formation for faster con
`ventional pedicle screw insertion with precision and vertebra
`fixation.
`
`18 Claims, 23 Drawing Sheets
`
`Globus Medical, Inc. Exhibit 2011, Page 1 of 41
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
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`U.S. Patent
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`Aug. 7, 2012
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`Fig. 1
`(Prior Art)
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`Sheet 2 of 23
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`18
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`Globus Medical, Inc. Exhibit 2011, Page 4 of 41
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`Globus Medical, Inc. Exhibit 2011, Page 5 of 41
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`Globus Medical, Inc. Exhibit 2011, Page 8 of 41
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`Globus Medical, Inc. Exhibit 2011, Page 11 of 41
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`Globus Medical, Inc. Exhibit 2011, Page 12 of 41
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`Globus Medical, Inc. Exhibit 2011, Page 17 of 41
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`U.S. Patent
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`Globus Medical, Inc. Exhibit 2011, Page 18 of 41
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`US 8,236,006 B2
`
`1.
`ONE STEP ENTRY PEDICULAR
`PREPARATION DEVICE AND DISC ACCESS
`SYSTEM
`
`This is a continuation-in-part of U.S. patent application
`Ser. No. 12/009,496 filed Jan. 17, 2008 now U.S. Pat. No.
`8,075,579.
`
`FIELD OF THE INVENTION
`
`The present invention relates to improvements in the field
`of spine Surgery and more particular to a system for the ability
`to perform spine Surgery through a small opening, the loca
`tion, placement, and insertion of temporary pedicular
`implants called PediDartTM pedicle darts which are appli
`cable to both MIS and open surgical technique and which
`allows for more exact and rapid placement with correctangu
`lar insertion of fixation members into the spinal pedicle,
`which will facilitate one of the most difficult phases of spine
`Surgery. The result is increased safety of placement and inser
`tion of the pedicle screws, avoiding potential devastating
`complications to the adjacent neurovascular structures as well
`as less time spent on the operating table. The same basic
`design of the PediDartTM pedicle dart system with minor but
`important modifications can then be applied to percutane
`ously access the intervertebral discs for the purpose of biopsy
`or implantation of stabilizing or bioactive materials.
`
`10
`
`15
`
`25
`
`BACKGROUND OF THE INVENTION
`
`2
`structures or inadequate purchase of the screw to the bony
`vertebra resulting in unstable fixation and failure of fusion.
`Malplacement of pedicle screws have been reported to occur
`between 6-12% whenevaluated by plain X-rays and up to 35%
`when examined with the more accurate axial computerized
`tomography techniques. Serious complications from malpo
`sitioned pedicle screws are approximately 2% due to the
`anatomic "safety margin' leaving adequate space between
`the vital neurologic structures and the bony spinal canal to
`accommodate for the error.
`Nevertheless, a more exact and precise way to accurately
`insert a pedicle Screw into the thoracic lumbosacral spine is
`not only desirable but necessary. Improved techniques and
`instruments are especially needed when “percutaneous'
`methods of spinal fixation are utilized such as with the “path
`finder system (Abbot Spine), Expedium (Depuy) or Sextant
`(Medtronics) to name a few systems. The method of pedicle
`screw placement with the percutaneous systems are to first
`localize the entry point with fluoroscopic imaging passing a
`Jamshidi needle/probe through a small skin incision, docking
`into the pedicle entry point and then driving the Jamshidi
`probe through the pedicle into the vertebral body. This is
`followed by the insertion of a guide pin over which a cannu
`lated tap is applied followed by pedicle screw placement.
`Infrared navigational methods can also be used to guide
`placement of the pedicle screw.
`There are several drawbacks and limitations with the cur
`rent technique of pedicle Screw insertion. This technique has
`also been referred to as the “feel technique.
`(1) Entry point location by Surface anatomical features are
`inaccurate due to bony anomalies. Variations of development,
`bony bumps and spurs develop differently with time.
`(2) Incorrect entry points can lead to trajectory error which
`can result in perforation of the pedicular wall. Medial perfo
`ration will jeopardize neural structures or epidermal vessels.
`Lateral perforation will result in lack of stability due to failure
`of the screw engaging the vertebral body.
`(3) The cancellous core of the pedicle may be too small
`(type B pedicle) or non-existent (type C pedicle) or lack
`continuity (type D pedicle) to allow accurate passage through
`the center of the pedicle to engage the vertebral body.
`(4) The use of the hand-held metallic probe is physically
`arduous leading to Surgeon fatigue.
`(5) Additional steps of sequential tapping require time
`prior to final screw placement.
`Further, the percutaneous technique has the following
`drawbacks.
`(1) the Jamshidi probe is too flimsy and often too short,
`making it difficult to properly dock onto the entry point.
`(2) The Jamshidi probe is too flimsy to navigate down a
`hard pedicle without deviating from the center of the pedicle.
`(3) At times even after the vertebral body is reached, the
`guide wire is difficult to advance through hard bone.
`(4) The additional steps of sequential tapping is required
`before placement of the pedicular screw.
`Inaccurate placement of the pedicle screw may result in
`damage to the vertebrae Such that screw insertion may not be
`possible, or if it can be achieved it may require additional
`Surgical procedures for correction to provide the necessary
`holding strength.
`Other conventional techniques for insertion of the pedicle
`screw may involve extensive paraspinous muscle dissection,
`impairment of Surrounding tissue and other compromising
`tissue removal commonly necessary to properly insert a
`pedicle screw. This most often results in significant blood loss
`during this exposure phase of the operation, which is only one
`
`Surgical procedures in general and spine Surgical proce
`dures in particular have progressively evolved to a minimally
`invasive approach over the past two decades. The advantages
`for the patient have been well documented with less pain,
`blood loss and tissue damage all contributing to a faster
`recovery and improved function with fewer complications.
`However, the smaller exposure of the surgical field has pre
`sented a challenge to the Surgeon to accomplish the same
`goals of a successful open procedure with a technique thatless
`direct visualization of the operative site. To perform surgery
`through a smaller opening with maximum safety to the
`patient, newer tools and inventions have become necessary.
`The PediDartTM pedicle dart system contributes to the grow
`ing but still deficient list of tools required to perform safe,
`minimally invasive spine Surgery.
`Spinal fusion with internal fixation instrumentation using
`pedicle screws have become the “gold standard” for posterior
`thoracic and lumbosacral fusion using internal fixation. For
`optimal results and safety it is required to accurately place
`bone screws (pedicle screws) from the outer surface or cortex
`of the pedicular segment of a vertebrae and advance down the
`cancellous core of the pedicle to engage the threads of the
`screw into the body of the vertebrae. Two or more adjacent
`vertebra are then connected by placement of rods transfixed to
`the pedicle Screws by a locking cap or nut, or by crimping.
`To the accomplished spine Surgeon Such insertion of a
`pedicle Screw is most commonly accomplished by first per
`forating the entry into the pedicle located at the junction of the
`transverse process and Superior facet with a pointed metallic
`probe, and then following the path of least resistance through
`the cancellous core of the pedicle and then into the vertebral
`body. Proper location of the metallic probe is confirmed with
`X-ray or other navigational method. The path created by the
`probe is then tapped or threaded to prepare for placement of
`the pedicle Screw of the proper length and dimension.
`Improper or inaccurate placement of the pedicle Screw can
`result in catastrophic injury to neurological, Vascular or bowel
`
`30
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`35
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`40
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`3
`part of a multiple step operative procedure. Any problems at
`any stage of an operation can risk the patient’s safety and
`Surgical outcome.
`The surgical practitioner is faced with the choice between
`high exposure and a good view but increased tissue damage,
`Versus a more limited exposure with a much poorer view and
`a heightened risk of a wrong insertion of the pedicle screw, but
`with potentially better outcome.
`What is needed is a system which will enable correct place
`ment of a pedicle device, accurately and consistently and
`which will not require extensive paraspinous muscle dissec
`tion for proper placement. The needed device will ideally
`enable a gradual graded introduction into the pedicle and give
`an earlier indication of problems so that any error can be
`quickly corrected at a time before the introduction goes any
`further.
`Currently available surgical retractor systems fail to fulfill
`all of the above requirements. Consequently there is a severe
`need for complementary tools and inventions to meet the
`requirements of precise, safe and timely spine fusion Surgery.
`
`5
`
`10
`
`15
`
`SUMMARY OF THE INVENTION
`
`The system and method of the invention, illustrates a vari
`ety of structures and techniques to enable a staged location
`and entry into the pedicle for providing insertive, progres
`sively larger threaded fixation and Superior Surgical control a
`distance from the spine. The PediDartTM pedicle dart system
`offers a one step preparation for pedicle screw insertion in the
`safest and most accurate way possible with current imaging
`technology which may include X-ray or infrared, or RF navi
`gational guidance. This allows for faster complex spine Sur
`gery procedures, decreased cost, decreased anesthesia time
`and complications such as Surgery time dependent post
`operative infections. The device and method can be utilized
`manually or power driven and can be used open, minimal
`open or percutaneous Surgical approaches.
`The advantages of the PediDartTM pedicle dart system
`includes:
`(1) The larger than usual guide pin (of about 2 millimeters in
`diameter) allowing for a sharper and more stable trocarpoint
`to precisely dock and hold to the entry point without slippage.
`(2) The larger guide pin resists bending and consequently
`binding which is a major drawback to current guide pin sys
`temS.
`(3) The limited exposure length of the guide pin not only
`resists bending, but minimizes excessive penetration in the
`spine and beyond which can result invascular or bowel injury.
`(4) The tip end of the PediDartTM pedicle dart system begins
`with a cutting thread to quickly capture the cancellous bone in
`the case of the bony pedicle.
`(5) The Pedi DartTM pedicle dart systems fluted shaped
`advances Smoothly down the inner pedicle and gradually
`expands the cancellous inner bone so that sequential tapping
`is not necessary.
`(6) The fluted shape can also safely expand immature pedicu
`lar bone such as with adolescent idiopathic scoliosis Surgery
`allowing placement of the largest pedicle screw for the best
`stability.
`(7) The non-cutting threads at the larger end of the flute
`compresses and strengthens the cancellous pedicular bone to
`give better purchase to the pedicle screw.
`(8) The smaller diameter of the entry end of the PediDartTM
`pedicle dart system preserves the bone in the vertebral body
`for best pedicle screw purchase especially important for the
`osteopathic spine.
`
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`(9) The cone shaped channel created by the fluted PediDartTM
`pedicle dart system allows maximum contact to the entire
`length of the pedicle screw.
`(10) The cone shaped channel created by the PediDartTM
`pedicle dart system allows for accurate advancement of the
`pedicle screw.
`(11) The Smooth part of the shank gives greater length to the
`PediDartTM pedicle dart system when used as a temporary
`implant to compress or distract a motion segment such as for
`the placement of an intervertebral or disc space implant.
`(12) The sloped buttress at the tail end of the PediDartTM
`pedicle dart system keeps the system from excessive penetra
`tion.
`(13) The sloped buttress at the tail end provides for a “flared
`entry point for the pedicle screw.
`(14) The inner slot and lock mechanism provides the most
`powerful way to rotate the PediDartTM pedicle dart system
`into and out of the spine.
`(15) The “hockey stick” shaped external slot provides an
`additional way to remove the PediDartTM pedicle dart system
`when it is deeply inserted in a large patient, and particularly
`where some other object or tissues blocks rearward motion of
`the pedicle dart.
`(16) The tapered inner hollow structure facilitates proper
`engagement between the pedicle dart and the manipulator/
`insertion tool.
`(17) The inner spring of the PediDartTM pedicle dart system
`mates to the circular slot of the insertion tool/manipulator
`capturing the pedicle dart but yet still allows for disengage
`ment.
`(18) The handle of the insertion tool/manipulator is designed
`for the best tactile feel and control for the surgical practitio
`.
`(19) The modular end of the insertion tool/manipulator can
`adapt for navigational points, impacting tool or power attach
`ment.
`(20) The length of the insertion tool/manipulator keeps the
`Surgeon’s hands away from the X-ray beam.
`(21) The Pedi)artTM pedicle dart system can serve as a tem
`porary implant, a permanent implant or a structure for a stand
`alone screw and rod system. It can also be adapted for inter
`vertebral disc access (“Disc Pedi DartTM).
`A first embodiment of the pedicle dart system is simple and
`has a small number of components. These components
`include a guide pin, a pedicle dart fastener (preferably having
`Some control structure for easy manual rotation) having a
`central opening to accommodate the guide pin, an indexed
`sleeve (preferably with handle) having a central opening to
`accommodate the threaded pedicle dart fastener to hold the
`dart to the sleeve. The threaded pedicle dart fastener should
`have a manual control Surface which facilitates it axial rota
`tion with respect to the indexed sleeve. The indexed sleeve
`preferably has a handle to enable rotational turning of the
`pedicle dart into the pedicle for ease and control.
`The first embodiment of the pedicle dart system enables
`use of the threaded pedicle dart fastener to both engage and
`disengage from an implaced pedicle dart. The indexed sleeve
`can impart rotational force of the sleeve directly into the
`pedicle dart due to the indexed connection between the
`pedicle dart and indexed sleeve. The threaded pedicle dart
`fastener is used to engaged and pull the pedicle dart to an
`indexed position with respect to the indexed sleeve.
`The preferred method of indexing for the first embodiment
`involves a pair of oppositely located fingers at the end of the
`indexed sleeve which are narrower than indexed slots located
`rearward of each of the pedicle darts. By making the fingers of
`the indexed sleeve narrower than the indexed slots rearward
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`Globus Medical, Inc. Exhibit 2011, Page 26 of 41
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
`

`

`US 8,236,006 B2
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`of each of the pedicle darts, the registry of the fingers of the
`indexed sleeve into the pedicle dart slots will occur much
`more rapidly. This enables easy location and re-attachment of
`the pedicle screw no matter whether the pedicle dart is
`attached away from the patient by hand or whether an
`implaced pedicle dart is re-attached for engagement with the
`pedicle dart system to remove it.
`Further, the first embodiment of pedicle dart system also
`contemplates the use of the darts as starter devices to facilitate
`the placement of larger and higher profile conventional
`pedicle screws where necessary. In this limited view of the
`system, it can be viewed as a pedicle screw bore starter while
`eliminating the need to perform undue paraspinous muscle
`disturbance.
`Moreover, as designed, one of the important aspects of the
`pedicle dart system involves the location of smaller fixation
`structures (pedicle darts) which have a lesser upward projec
`tion from the lumbar vertebra during the operation. This
`enables a major advance over the conventional art in which
`the need to place pedicle screw fixation devices before the
`Surgical procedure often get in the way of (a) the ability to
`manipulate manual instrumentation to accomplish the proce
`dure, (b) other structures used with the procedure, and (c)
`general visual obstruction of the Surgical area.
`The pedicle darts can be made in a variety of sizes, all of
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`which can exhibit a much lower profile adjacent the Surgical
`area. Conventional pedicle screws project high on the patient,
`perhaps to overcome the difficulty which would accompany
`conventional methods of accessing the conventional pedicle
`screws. The pedicle dart system provides instrumentation to
`reach in and re-engage otherwise hidden pedicle fixation
`devices. The pedicle dart system of the invention can also
`enable located re-attachment of larger pedicle darts or pedicle
`dart extensions to form the fixation needed. Conventional
`pedicle screws have a proud, high profile proximal connect
`ing end which can impair access to placing intervertebral
`implants such as with a TLIF procedure. The pedicle dart
`system enables a level of flexibility not seen in conjunction
`with other fixation devices.
`Further, it is not required that the darts must be able to be
`inserted using a thread. They can be inserted by pushing or
`turning, such as acting to bore into the bone using a non
`threaded action. Such shapes may be advantageous in remov
`ing bone in a way that will not bind or tend to put significant
`lateral pressure on bone tissue in the pedicle.
`The use of the pedicle dart system provides a high number
`of significant advantages over the use of conventional pedicle
`SCCWS.
`1. The pedicle dart system enables the use of percutaneous
`technique, with the result that there is much less blood loss.
`2. The pedicle dart system is completely compatible with the
`use of bi-planer fluoroscopy or navigational method, espe
`cially with the elongated components, allowing the insertion
`of the pedicle dart in a much can be precise manner.
`3. The pedicle dart system facilitates placement of a tempo
`rary pedicle dart which decreases blood loss from the hole or
`bore in which the pedicle dart is implaced.
`4. The pedicle dart system enables the use of a low-profile
`pedicle dart that does not interfere with retraction blades, thus
`allowing for greater visibility of the surgical field.
`5. The pedicle dart system enables percutaneous localization
`of the pedicle and insertion of the pedicle dart as a marker
`decreases the necessity of wide muscle stripping and there
`fore patient damage.
`6. The pedicle dart system enables the use of a technique that
`allows for the preservation of the vascularity and the inner
`Vation to the longissimus muscle, which always had to pre
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`viously be sacrificed using the traditional (non-pedicle dart
`technique). The avoidance of destruction to the longissimus
`muscle allows for a healthier paraspinous muscle and
`decreases the incidence of chronic pain associated with de
`vascularized fibrotic paraspinous tissue.
`7. Traditional placement of the conventional pedicle screw
`has high incidence of association with breach of the pedicular
`wall, which can lead to serious complications. The precision
`placement of the trans-pedicular path using the pedicle dart
`technique will minimize such complications.
`8. Most important, there is a significant Surgical time-saving
`component, as lengthy muscle dissection and direct exposure
`will no longer be required.
`9. The shortened Surgical time will mean less Surgical time,
`providing significant cost savings for the entire health-care
`system.
`A second embodiment of the pedicle dart system has a
`number of features where it is desired to have a quick-connect
`and quick-disconnect system. A 'T' shaped slot on a pedicle
`screw which may include a number of structures transitioning
`to a higher diameter are illustrates. This second embodiment
`can be left as a marker and can be distracted or compressed
`more directly and more quickly than the first embodiment due
`to the quick engagement bi-directional engagement of the
`“T” shaped slot.
`Both of embodiments of the dartherein may be expected to
`be disposed of after a single operation. Otherwise the darts
`might become dull with use, including the forward cutting
`edge and the threads. A number of transition Surfaces assist
`the practitioner in making a stop and insuring that the pedicle
`dart can go forward only so much as is necessary. The 'T' slot
`of the second embodiment will also assist the practitioner in
`ascertaining depth, and in watching the number of full rota
`tions. The “T” slot provides for instant rotational engagement
`and actuation in either the clockwise or counter clockwise
`position. Further, the quick connect and disconnect enables
`the Surgical practitioner to start and advance or remove sev
`eral pedicle darts serially, without having to engage and dis
`engage a central member after engagement by finger projec
`tions.
`In the second and further embodiments, the pedicle dart
`may be about five centimeters long and have a number of
`cylindrical and conical Surfaces which increase in diameter
`from the distal tip to the proximal engagement end. The five
`centimeter length may include about two and a half centime
`ters of tapered threaded surfaces, about one and a half to two
`centimeters of a cylindrical portion, and then an optional
`conical transition portion which may have an axial length of
`about two millimeters to about four millimeters in length. An
`engagement portion may have a length of about one centime
`ter.
`The proximal tip may be a diameter of about two millime
`ters. The cutting tip may have a thickness of from about one
`tenth of a millimeter to about five tenths of a millimeter. The
`diameter of the distal portion of the tapered or gentle conical
`threaded portion may be about one half of a centimeter. The
`thread pitch may be from about four to six per centimeter of
`axial length of the pedicle dart. The threads are preferably of
`low height, typically from about two tenths to about six tenths
`of a millimeter and a width from about two tenths to about six
`tenth of a millimeter and having a shape which rises evenly
`about their radially spiral extent from the tapered frusto
`conical shape. Given that bone is soft, the threads are used
`more as a guide to help the practitioner set the rate at which
`the darts are inserted, rather than used to engage and advance
`the dart. Further, the low height threads can be used to advan
`tage for a number of purposes. The shallow threads serve as a
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`Globus Medical, Inc. Exhibit 2011, Page 27 of 41
`Life Spine, Inc. v. Globus Medical, Inc.
`IPR2022-01602
`
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`7
`visual indication of insertion and extraction progress with the
`amount the length of the threads serving as a progress gauge.
`The extent that positive urging force accompanies a rotational
`force, the low height threads, coupled with a visual insertion,
`helps the Surgical practitioner have a better and more cautious
`approach on insertion. The amount of pressure needed for
`insertion will be high for rapid insertion and low for
`extremely slow insertion, but the ability to view the threads
`upon insertion gives the Surgical practitioner a feedback
`which is matched to a rate of insertion. The rate is visually
`ascertainable by seeing whether the insertion of the threaded
`portion enters in a way which either tracks the turning of its
`threads, is ahead of the turning of its threads or lags the
`turning of its threads.
`Further, when the pedicle dart of the invention is used to
`help remove material especially in contemplation of insertion
`of a regular pedicle screw, the turning of the pedicle dart
`without advancing the pedicle dart enables the low height
`threads to act as a gentle auger for removing bone from the
`formed bore and for scrapingly smoothing the formed bore.
`Especially in pediatric patients, the ability to perform agentle
`auguring of the pedicle bore prior especially where the
`pedicle dart is used to lead the way for insertion of a pedicle
`screw, can be advantageously much more safely performed.
`The shallow threads avoid cutting the bone too deeply
`which could weaken the all of the pedicle. The dimensions for
`the second embodiment may preferably protrude above the
`operative field up to about one centimeter when the pedicle
`dart is fully inserted. Further, a larger, longer pedicle dart
`having a series of stepped or conical tapered transitions can
`enable a longer guide pin, and possibly a lager guide pin for
`greater stability, particularly where the intermediate member
`for threaded engagement, which lies between the guide pin
`and the outer housing, is eliminated.
`Further, the second embodiment is particularly amenable
`to have a use as a one step entry pedicular preparation device.
`With one device setup, the Surgical practitioner can, prefer
`ably using fluoroscopy, locate an entry point, insert the guide