CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 1
`
` IN THE UNITED STATES DISTRICT COURT
` SOUTHERN DISTRICT OF CALIFORNIA
`- - - - - - - - - - - - - - - X
`WARSAW ORTHOPEDIC, INC., : Case No.:
` Plaintiff, : 3:08-CV-1512 MMA(AJB)
` vs. :
`NUVASIVE, INC., : Judge:
` Defendant. : Hon. Michael M. Anello
`- - - - - - - - - - - - - - - X
`NUVASIVE, INC.,
` :
` Counterclaimant,
` :
` vs.
` :
`MEDTRONIC SOFAMOR DANEK
`USA, INC.; WARSAW :
`ORTHOPEDIC, INC; MEDTRONIC CONFIDENTIAL
`PUERTO RICO OPERATIONS CO.; :
`and MEDTRONIC SOFAMOR DANEK
`DEGGENDORF, GmbH, :
` Counterclaim Defendants. :
`- - - - - - - - - - - - - - - X
`
` Cary, North Carolina
` Friday, December 3, 2010
` Videotaped Deposition of LAWRENCE BOYD, Ph.D.,
`a witness herein, called for examination by counsel for
`the Plaintiff/Counterclaim Defendants in the
`above-entitled matter, pursuant to notice, the witness
`being duly sworn by MAREN M. FAWCETT, a Registered
`Professional Reporter and Notary Public in and for the
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 1
`
`WARSAW2020
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 6
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`09:01:13
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` P R O C E E D I N G S
` THE VIDEOGRAPHER: This is the videotaped
` deposition of Larry Boyd. Today's date is
` December 3rd, 2010. The time is 9:01.
` The court reporter's name is Maren Fawcett.
` The videographer is Larry Schadle. Would counsel
` please introduce themselves.
` MR. DAUCHOT: I'm Luke Dauchot. I'm here on
` behalf of the Plaintiff and the Counterdefendants.
` MR. MILLER: Todd Miller of Fish & Richardson
` on behalf of Nuvasive and Fish & Richardson.
` THE VIDEOGRAPHER: Would the court reporter
` please swear in the witness.
` MR. MILLER: I'm sorry.
` MR. DAUCHOT: You said you're on behalf of
` Fish & Richardson?
` MR. MILLER: It's a little early in the
` morning. On behalf of Nuvasive and Dr. Boyd.
` THE VIDEOGRAPHER: Oh, I'm sorry.
` MR. MILLER: There we go.
` THE WITNESS: You ready?
`Whereupon,
` LAWRENCE BOYD, Ph.D.,
`called as a witness by counsel for the
`Plaintiff/Counterdefendants, and having been duly sworn
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 2
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 7
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`by the Notary Public, was examined and testified as
`follows:
` DIRECT EXAMINATION
`BY MR. DAUCHOT:
` Q. Dr. Boyd, good morning.
` A. Good morning.
` Q. My name is Luke Dauchot. I don't know that
`we've met before.
` A. We haven't, no.
` Q. We haven't. Congratulations on becoming a
`doctor. I guess that's relatively recent.
` A. Last deposition I was not Dr. Boyd, so.
` Q. All right. Well, you've been deposed before,
`I know that.
` A. A few times, yeah.
` Q. A couple reminders to help the process along
`today. First, if you don't understand a question, let
`me know. I'll do what I can to make it clearer. But if
`you do answer, I'll assume you understood. Fair enough?
` A. Fair.
` Q. Be sure to keep all of your answers both
`verbal and audible. I understand a nod of the head, but
`a court reporter can't take that down.
` A. Great. Yeah, I will try to do that.
` Q. All right. Third, let me finish my question
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 3
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`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 25
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`09:25:36
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` MR. MILLER: Why are you giving it a new
` number?
` MR. DAUCHOT: That's a fair question. I'm not
` sure I need to.
` MR. MILLER: Yeah, I think what we've --
` MR. DAUCHOT: The only reason I am giving it a
` new number is because it says Lukianov.
` MR. MILLER: I think what we've done in the
` past is just reuse the exhibit.
` MR. DAUCHOT: Okay. Let's do that. Undo
` here. Do a revision procedure.
` THE WITNESS: Careful.
` MR. DAUCHOT: There we go, I'm going to hand
` you what's been previously marked Lukianov's
` Exhibit 133. Todd, did I hand you that?
` MR. MILLER: You did. Thank you.
`BY MR. DAUCHOT:
` Q. All right. Take a moment to look that over,
`if you would. I know you recognize the document.
` A. I believe I've seen this document a few times.
` Q. All right.
` A. Just give me a second to review it if you
`will.
` Q. Sure.
` A. Okay. I've reviewed it.
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 4
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`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 26
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`09:28:02
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` Q. All right. This is a document that you
`authored?
` A. Yes, I dictated this.
` Q. And at the time that you drafted this
`memorandum, so we're now January 11, '94, according to
`your curriculum vitae, you were a product development
`manager at Sofamor Danek?
` A. Correct.
` Q. All right. Question, why is product -- strike
`the question.
` I take it that you drafted this memo because
`this was something that you did in the ordinary course
`of your -- your practice back then as an employee of
`Sofamor Danek, fair?
` A. You're asking me that I wrote this because it
`was part of my job?
` Q. Yeah.
` A. Yes.
` Q. Okay. Part of your job was to communicate to
`individuals, such as Mr. Pafford, Mr. Brumfield, who are
`the recipients, along with others who you've copied
`about product development meetings that you had with,
`among others, surgeons, fair enough?
` A. To communicate with them in general about any
`activities that I performed in the course of business.
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 5
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 27
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` Q. All right.
` A. Period.
` Q. And this was one such memorandum, what's been
`marked as 133?
` A. Correct.
` Q. Okay. Now, let me flip back, your --
`according to the memorandum, you met with Dr. Michelson
`and others on Tuesday, January 11. Do you see that?
`That's the first line.
` A. Yes.
` Q. Is that the first time you met with
`Dr. Michelson?
` A. Yes. I don't recall meeting him before then.
` Q. Okay. Now, at this meeting -- let me take a
`step back. Do you have an independent recollection of
`Dr. Michelson at this meeting showing you prototypes of
`an interbody fusion cage designed to be inserted
`translaterally?
` MR. MILLER: Objection; vague.
` THE WITNESS: Can you -- independent
` recollection, I'm not familiar with that. What do
` you mean by that?
`BY MR. DAUCHOT:
` Q. What I mean by that is if we put the memo
`aside --
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 6
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 31
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`09:34:35
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`recall Dr. Michelson using.
` Q. Okay. And what do you remember about
`Dr. Michelson using that term?
` A. Just a large diameter cage. So conventional
`cages were in the 18 to 20 range and these were larger
`than those diameters typically. And at the -- I don't
`know when that sort of came into existence in terms of
`terminology, but of course we use that term.
` Q. Okay. And do you recall Dr. Michelson
`explaining that the jumbo cage had an advantage because
`it is one that could be inserted into the intervertebral
`space from a lateral aspect as opposed to a posterior or
`anterior aspect?
` MR. MILLER: Objection; vague.
` THE WITNESS: No, I don't recall that.
`BY MR. DAUCHOT:
` Q. You don't have a memory of that?
` A. I don't.
` Q. Okay.
` MR. MILLER: You get to use that thing after
` all.
` MR. DAUCHOT: See if I can salvage it. I
` don't want to waste the court reporter's perfectly
` good sticker. All right.
`BY MR. DAUCHOT:
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 7
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 32
` Q. I've marked as Exhibit 220 a document bearing
`Bates stamp NUM0278500 through and including 8504.
`Todd, here's your copy.
` MR. MILLER: Thank you.
`BY MR. DAUCHOT:
` Q. And let me take a step back here, Mr. Boyd,
`when is the last time that you saw Exhibit 133?
` A. I don't know. Somehow relative to the
`litigation between Medtronic and Dr. Michelson, but I
`can't tell you when.
` Q. Okay.
` A. You probably have better record of it than I
`do, so.
` Q. All right. Let's look at Exhibit 220. My
`first question is, is that your signature that appears
`on the second page?
` A. Yes, that is my signature.
` Q. All right. The letter is dated January 13th,
`1994. Do you see that?
` A. Well, there is two things attached. There is
`a January 13th and then there is -- a couple pages back
`there is a January 14th. So we've got two -- looks like
`we have two letters here.
` Q. Oh, fair enough. You do. So why don't we
`just cover both at the same time.
`
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`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 8
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 33
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`09:37:49
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` A. Okay.
` Q. Is that your signature that appears on both
`letters?
` A. That's correct.
` Q. January --
` A. Both the letters, right.
` Q. All right.
` A. One letter is three pages and the other is two
`looks like.
` Q. All right. Let's focus on the first letter,
`January 13, '94.
` A. Okay.
` Q. I take it that this letter, Dr. Boyd, as well
`as the one dated January 14, 1994 were authored by you
`in connection with your responsibilities and in the
`ordinary course of your duties for Sofamor Danek; is
`that correct?
` A. That's my belief.
` Q. All right. And it was your job at or about
`this time to make these sorts -- to have these sorts of
`communications, if you will, with individuals such as
`Dr. Michelson?
` A. It was part of my job responsibilities, yes.
` Q. All right. In the -- if we flip to the second
`page of the letter dated January 13, '94.
`
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`
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`Page 9
`
`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 34
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`09:39:16
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` A. Let me just look at the front page for a
`second.
` Q. Sure enough.
` A. Okay. I'm on the second page.
` Q. All right. And just I guess let's add a bit
`more context here. If we look at the first page, first
`paragraph, you state: "Dear, Dr. Michelson, it was good
`to talk with you today." Do you see that?
` A. I see that.
` Q. So apparently you had a follow-up conversation
`with Dr. Michelson after the January 11, 1994 meeting?
` A. This would imply that.
` Q. Right. You state: "I'm very enthusiastic
`about moving forward with the many fusion device
`concepts." Do you see that?
` A. I see that.
` Q. "As we discussed, we would like to begin
`working on the various implant and instrumentation
`designs." Do you see that?
` A. I see that.
` Q. All right. "We covered a great deal of
`information in our discussions, so I have listed some of
`the things we discussed." Do you see that?
` A. I see that.
` Q. Fair to say that you're referring to the
`
`800-826-0277
`
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`Page 10
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`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 130
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` vertebral body, the transverse width of the
` vertebral body. So that's in the range that you
` would use, but I don't know exactly what sizes we
` planned to commercialize today.
`BY MR. MILLER:
` Q. I'm going to show you -- you can keep those
`together. Could you pull out Exhibit 135 from this
`stack.
` A. One thirty-five.
` Q. It looks like this on the top (Indicating).
` A. Oh, Lukianov 135, sorry. What does it look
`like? Is that it? Yeah.
` Q. Okay.
` A. Okay.
` Q. And for the record, Lukianov 165 is
`MNUV274049.
` A. One thirty-five. You said "165."
` Q. Thank you. Exhibit Lukianov 135. And,
`Dr. Boyd, this document is a memo that you created,
`correct?
` A. I believe so, yes.
` Q. All right. And if you'll turn to MNUV274061.
` A. Yes.
` Q. This document refers to "competition." Do you
`see that as the header?
`
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`
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`
`
`Page 11
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`

`

`CONFIDENTIAL
`LAWRENCE BOYD, Ph.D. - 12/3/2010
`
`Page 131
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` A. I do.
` Q. All right. This memo is from January 26,
`1994?
` A. Correct.
` Q. Now, Mr. Dauchot asked you about timing as to
`your recollection as to when you first knew about the
`BAK implant and the Ray implant and the Branigan cages.
`Do you recall that?
` A. Yes.
` Q. Does this document help you place in time when
`you would have first learned of those cages?
` A. No.
` Q. Is it safe to say that you knew about these
`cages as of the time you wrote the memo?
` A. Well, I wrote the document. Clearly, I've
`been aware of it.
` Q. This is the point.
` A. Okay.
` MR. DAUCHOT: And I'm going to object, you
` know. This is shameless coaching and trying to
` rehabilitate. I mean, we've gone over this.
` Anyway, it's coaching and let's go on.
`BY MR. MILLER:
` Q. Is it fair to say that you knew about these
`cages at least as early as January 26, 1994?
`
`800-826-0277
`
`Merrill Corporation - Los Angeles
`www.merrillcorp.com/law
`
`
`Page 12
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`

`

`Confidential
`
`MEMORANDUM
`
`To:
`
`John Pafford
`David Brumfield
`
`From:
`
`Larry Boyd
`
`Date:
`
`January 11, 1994
`
`cc: Ted Bird
`Ron·Pickard
`Alex Lukianov
`Rick Duer
`v'Brad Estes
`Roger White
`
`Subject: MEETING WITH DR. GARY KARLIN MICHELSON
`
`On Tuesday, January 11, Ron Pickard, Rick Duerr, Mark Merrill, and I met with Dr.
`Michelson and his attorneys. While the attorneys worked out the details of the various
`agreements, Ron Pickard and I were able to meet with Dr. Michelson to review his various
`ideas on interbody fusion and spinal surgery. Dr. Michelson reviewed with us the many
`assorted prototype implants and instruments covering a wide range of subjects.
`
`Initially, Dr. Michelson pointed out that there are generally three steps performed in a
`spinal surgery. These would be a discectomy, an interbody fusion via either posterior or
`anterior approach, and some form of instrumentation for additional stability. Dr.
`Michelson pointed out that the ideal case would be to eliminate the need for additional
`instrumentation via improving the biomechanical performance of the implant used for .
`interbody fusion. This would appear to be the ultimate goal of the various implant and
`instrumentation systems for interbody fusion that we were to discus with Dr. Michelson..
`
`Next, Dr. Michelson reviewed step-by-step some of the details of the surgical procedure for
`posterior interbody fusion approach:
`
`1.) The first step involved detailed pre-operative planning. This would be via templates of·
`the various implant sizes that would be available in various magnification ranges. A
`lateral X-ray would be used topre-operatively assess the anticipated implant depth and
`allow the surgeon to assess the anticipated implant height required in order to restore
`normal anatomy. An axial CT scan would be used to clarify the actual disc space available
`and the true anticipated implant depth to be used.
`
`~HIBIT NO.J.
`
`W/o.t).-MV "
`
`/./..11 t>
`J. HOSTETlER
`
`'
`~~
`
`Conlldentlallnlonnallon
`
`MaD 1041411
`
`
`Page 13
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`

`

`Meeting with Dr. Gary Michelson
`January 11, 1994
`Page 2
`
`2.) The second step would involve removing some small portion of disc after an exposure
`of the disc from a posterior approach. A simple curette 01' rongeur could be used to
`remove enough disc to allow for placement of the initial bullet-nosed long distractors.
`
`3.) The third portion of the procedure involves placement incrementally of various bullet(cid:173)
`nose long distractors. These will indicate to the surgeon when the normal disc height has
`been restored. The surgeon will be able to feel as the disc space becomes increasingly taut
`and stable. The long distractors also assure that a central axis parallel to the endplates is
`achieved prior to any drilling. Dr. Michelson pointed out that this predistraction phase is
`very critical.
`It is important that the patient be fused in the fully extended, distracted
`position, as opposed to some surgeons who have accidentally fused patients in a collapsed
`p·osition resulting in eventual degeneration of adjacent disc levels. This predistraction is
`critical also to giving the necessary working space for insertion of the instrumentation and
`implant.
`.
`
`tubular
`4.) The next phase involves impacting into the vertebral body an external
`distractor (with engagement teeth) which will be the working channel for the rest of the
`procedure. This helps to maintain distraction throughout the procedure, along with the
`contralateral distractor. At this point, Dr. Michelson pointed out that it will be necessary to
`lock the surgeon into a given depth and diameter instrumentation set. Dr. Michelson
`suggested that the various depths used be color coded and that the surgeon be locked into
`using a given set for a predetermined diameter, also. At this point, the surgeon would
`then work with a specific set of reaming and tapping instrumentation, in order to avoid
`any potential for mixing of different sized instrumentation.
`
`5.) The next phase is the insertion of the diameter-reducing inner sleeve and the protected
`drilling of the disc and bone in preparation for the implant. Having set the stage in terms
`of the surgical procedure, Dr. Michelson discuSsed some of the more specific details of the
`design. He mentioned that cutting an arc is a means of increasing the surface area contact
`and therefore reducing the likelihood of subsidence. He mentioned some data and
`analysis via computer modeling that was performed that clearly shows the advantage of
`both the domed shape as· well as a tooth thread engagement into the vertebral bodies as
`opposed to simply placing a flat member in contact with the vertebral bodies. We will
`need to examine this information, now that the agreement is in place.
`
`Dr. Michelson also mentioned that the device used to remove the disc and bone is riot a
`typical sharp-pointed drill, but a side-cutting reamer that actually draws the disc and bony
`debris into the internal diameter-reducing sleeve. This captures the debris which would
`otherwise migrate about the body and perhaps cause further inflammation.
`
`Conlldlnllal Inlonnatlon
`
`MSD 1041472
`
`
`Page 14
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`

`

`Meeting with Dr. Gary Michelson
`January 11, 1994
`.
`Page 3
`
`6.) The next step is to remove a dowel of iliac crest autograft bone and load the implant
`with bone via the implant bone loading device, followed by insertion of the implant. This
`device holds the implant and bone dowel and drives the bone into the device. The bone is
`compacted into the device and extrudes from the pores in the device. Bone tapping. is not
`normally required due to the fact that the implant is self tapping. Tapping could in fact
`result in potential cross threading and a less than ideal fit between the implant and bony
`interface. We will need to do some studies of our own to assess the need for tapping in the
`. various cervical, thoracic, and lumbar applications of the implant and instrumentation.
`
`We then discussed some of the specific implant features. The implant holes were
`contrasted with the two large holes on the Spine Tech BAK system. The width to depth
`ratio has a clear affect on bone ingrowth and incorporation through the implant. Dr.
`Michelson mentioned some studies that exist showing that the- width across a hole must
`be at least as great as the depth, or thickness, of the material through which the bone must
`bridge. However, he pointed out that beyond some certain ratio if the bone width is too
`great incorporation will be less than ideal, as will load bearing capacity. This apparently
`has to do with the amount of support vs. thrugrowth of bony trabeculae provided by the
`I asked Dr. Michelson about the reasons for the small holes along the side of the
`implant.
`implant. This is contrasted with some other devices (BAK, Ray) which have left the sides
`of the implant closed in order to, supposedly, prevent fibrous tissue migration into the
`device. Dr. Michelson pointed out that this was a very clear misunderstanding on some
`investigators part. He stated that, in actuality, the way that he has judged success of a
`fusion has been by noting bony bridging along the outside of the implant. As such, he feels
`that the side holes and the bone that extrudes through them act as an aid in allOWing the
`bone to grow not only through the implant but actually around and encasing the implant.
`
`Dr. Michelson also mentioned that the HA coating is a preferred embodiment for the
`implant design, as this will further encourage active bone bonding and the migration of
`bone along the implant. He discussed the need to look into both short-term tricalcium
`phosphate and longer term hydroxyapatite coatings. The FDA's thoughts on a short-term
`vs. a long-term coating may weigh into this decision. Finally, he pointed out the good
`histology shown in animal studies that has demonstrated complete encasement of
`threaded implants in bone with bone bridging both through and around the implant.
`
`I was
`Dr. Michelson reviewed all the implants and instruments already manufactured.
`most impressed with the manufacturing work done on all these components. Please see
`the attached copies of photographs given to me showing the complete instrumentation set
`for the posterior lumbar. interbody fusion technique. Some additional instruments are
`required for the anterior lumber interbody fusion. We will be in touch with Dr. Michelson
`with the completion of the final agreement to secure several full sets of implants and
`instruments for review with other surgeons and for further design and development of
`this concept.
`
`Confidential lnlormlllion
`
`MSD 1041473
`
`
`Page 15
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`

`

`Meeting with Dr. Gary Michelson
`January 11, 1994
`Page 4
`
`Next, Dr. Michelson discussed application of his device for an anterior lumbar interbody
`fusion. He pointed out that during an anterior lumbar interbody fusion it is necessary to
`clearly visualize the posterior wall in order to remove any extruded disc fragments and
`make sure that all extruded or herniated disc fragments have been retrieved.
`It was not
`extremely clear what method was preferred for disc evacuation. Dr. Michelson implied
`that the method used for the discectomy would be a typical rectangular incision in the
`annulus followed by a use of curette and rongeurs for evacuation of the disc and exposure
`of the vertebral endplates. However, I was somewhat concerned about the lack of any
`central restraining structures such as the anterior longitudinal ligament or medial
`portions of the nucleus to prevent contact between the two bilateral devices. This is a
`subject that I will hope to cover with Dr. Michelson and other surgeons using threaded
`It appears that contact between the devices is
`dowel techniques via an anterior approach.
`not a concern. .
`
`Dr. Michelson pointed out a very interesting concept for attaching a threaded dowel to the
`vertebral.bodies via placement of an external staple. A figure of this is shown below.
`
`This takes advantage of the fact that the threaded cage has a 1 degree of freedom method of
`extrusion, that is, via rotational unscrewing; The staple would have a 1 degree of freedom
`method of extruding via axial pull-out. When one combines these two fixation methods
`they act in concert to seemingly reduce the potential dislocation of the other. Additionally,
`the staples are placed such that they are driven into holes which over estimate their
`angulation and therefore compress down on the implant as they are driven into the
`vertebral bodies. A lock screw fixes the staple to the implant. The staples are low profile
`
`Conl\denllllllnlonnlllion
`
`MSD 1041474
`
`
`Page 16
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`

`

`Meeting with Dr. Gary Michelson
`January 11, 1994
`PageS
`
`against the vertebral bodies. The round vertebral body is flattened via rongeurs or burrs to
`further encourage conformation of the staples to the vertebral body.
`
`The methodology of distraction followed by compression is something most surgeons
`would be very familiar with. Testing would certainly be needed on the concept. However,
`this sort of technique of anchoring and attaching an interbody fusion device with some
`sort of an external member for purchase of the vertebral bodies has been contemplated as
`part of the IBFD project with Dr. Kozak, also. Staples are dearly clinically well-known
`devices and likely to be well accepted in this sort of spinal surgery. This technology is not
`covered by the current agreement but. could be added later if there is such an interest. Dr.
`Michelson reinforced the fact that the current device alone is and has been found to be
`very safe without the use of the staples. Therefore, the staples may very well not be
`required in order to achieve a very good and successful result with the threaded dowel in
`an anterior lumbar interbody fusion. We will likely further review this concept later as we
`move forward with the development of this device.
`
`Next, we discussed the difference between Dr. Michelson's concept and that of the BAI<
`implant from Spine Tech. Overall, Dr. Michelson emphasized the fact that the primary
`design philosophy is to gently remove bone so as to not harm in any way the surrounding
`biological structures. Another goal is to maximize the available surface area for load
`bearing in order to reduce the likelihood of implant subsidence. Dr. Michelson discussed
`the Spine Tech device, emphasiZing the limited area available for bone placement. The
`Spine Tech device provides for only a minimal amount of bone autograft placement. The
`polyethylene endcaps, increased sidewall thickness, Acme-type (square) threads, and the
`central strut all take up a great deal of room that is not available for bone. The Spine Tech
`device cannot be preloaded due to the central strut, which is used for strength and for
`driving the implant. The central internal strut has a slot used for engagement and
`insertion of the implant. However, this presents difficulty when one attempts to unthread
`or remove the implant due· to lack of a positive locking onto the implant. This is
`contrasted with the very positive threaded and keyway attachment used with Dr.
`Michelson's technique, as documented in the patent drawings.
`
`The Spine Tech BAK implant provides for a gradual tapered bullet-nosed lead in area to
`distract the disc space as inserted, where Dr. Michelson's technique achieves distraction via
`external means, presenting some very dear biomechanical and sUrgical advantages.
`
`The Spine Tech device provides for no side holes due to their concerns over disc and
`fibrous tissue end growth. However, Dr. Michelson feels very strongly about
`the
`likelihood of bone bridging and incorporation not only through the implant, but along .the
`outer margins.
`
`Conlidenllalintonnllllon
`
`MSD 1041475
`
`
`Page 17
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`

`

`Meeting with Dr. Gary Michelson
`January 11, 1994
`Page 6
`
`Spine Tech's square Acne thread creates potential stress risers. and sets up the potential for
`fracturing and damage to the endplates, where the very frne V-thread of Michelson
`provides for a very strong engagement, yet an a traumatic cutting of the vertebral bone.
`
`The Spine Tech device features polyethylene endcaps thought needed for visualization.
`However, it was found that visualization was still not possible for fusion confirmation
`even with the polyethylene endcaps. As mentioned previously, the true sign of a
`successful fusion has been bridging bone all around the implant between the vertebral
`..
`bodies as a sign of a good surgical result.
`
`Dr. Michelson mentioned some concerns expressed by Dr. Marie-H~lme Plais about
`methods for achieving lordosis with the implant. Dr. Michelson discussed the use of
`various wedge-shaped bullet distractors. The AUF and PLIF distractors provide for a
`trapezoidal shape distraction, as shown below:
`
`AL!F
`
`pLrF
`These would then be followed by a trephine method to cut along these wedge-shaped
`trapezoidal endplates. That is, the long distractors must be left in place in the trephine
`method in order to maintain the lordosis.
`
`We then discussed some additional aspects of the use of the short distractors. These short
`distractors are used for balancing the bilateral placement of the devices. These are the last
`step in the incremental sizing process and may be especially important when reducing a
`spondylolisthesis. Dr. Michelson pointed out that a spondylolisthesis is generally reduced
`by vertical re-establishment of disc space height, rather than trying to horizontally pull the
`vertebral body back. That is, due to the tensile nature of the surrounding aIU).Jllus the
`establishment of disc height tends to swing the vertebral body up and back in a 4-bar
`mechanism-type motion.
`.
`
`conl1dlnUlllnlormellon
`
`MSD 1041476·
`
`
`Page 18
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`

`

`Meeting with Dr. Gary Michelson
`January 11, 1994
`Page 7
`
`Dr. Michelson also pointed out that the external tube used aft