Download - clique para assistir

© Copyright Baylis Medical Company 2007. The BMC logo, SInergy, and DataStream are Trademarks or Registered Trademarks of Baylis Medical Company Inc. Patents pending and/or issued. 11

TransDiscal TM System

For intervertebral disc biacuplasty in the management of axial low back pain


Mechanisms of Discogenic Pain

• Irritation of nerve endings in outer third of the annulus (Bogduk J Anat 1981)

• Mechanoreceptors are present in outer posterolateral portion of the lumbar disc

• Sensitization of nociceptors in chronic discogenic pain. (Burke JBJS 2002)

• In-growth of granulation tissue and small unmyelinated nerve fibers are present in degenerative disc. (Freemont AJ Lancet 1997)

• Nerve root irritation in full thickness tears• Increased shear stress across annular wall

Coppes MH et al. Spine 22:2342-50,1997, Roberts S et al. Spine 20:2645-51,1995

Kitano T et al. Clin Orthop 293, 372-377,1993, Bogduk N et al. J Anat 132:39-56,1981

Groen et al. Am J Anat 188:282-296,1990


Potential Mechanisms of Pain Relief by Heating

• Heating nerve tissue at 45 degrees Centigrade causes irreversible neural blockade

• Change the structure of the collagen fibers in the annulus, causing an increase in annular stability

Smith H.P., McWhorter J.M., Challa V.R., "Radiofrequency Neurolysis in a Clinical Model,“ Journal of Neurosurgery, Aug 1981, Vol. 55 pp.248-253

Shah RV, Lutz GE, Lee J, Doty SB, Rodeo S. Intradiskal electrothermal therapy: a preliminary histologic study. Arch.Phys.Med.Rehabil. 2001; ; 82:1230-1237.82:1230-1237.


History of Treating the Disc With Heat

Intradiscal RF Sluijter, 1994

IDET Smith and Nephew, 1998

DiscTRODE Tyco / Radionics, 2000


Patient Selection

Indications• Internal disc disruption• Chronic pain (>6 mo)• Failed conservative

treatment• Axial low back pain greater

than referred leg pain• Positive discography in 1

or 2 discs.• Abnormal disc morphology

Contraindications• Large decrease in disc height >50%• Extruded or sequestered herniation• Severe degeneration• Segmental instability• Neurological deficit• Pregnancy• Endplate damage or Schmorl’s nodes• Systemic infection or at site of

treatement• > 2 discs degenerated on MRI*

Kapural L, Mekhail N, Korunda Z, Basali A. Intradiscal thermal annuloplasty for the treatment of lumbar discogenic pain in patients with multilevel degenerative disc disease. Anesth Analg. 99(2):472-6,2004.


Transdiscal Bipolar RF Disc Treatment

• Radiofrequency current is concentrated between electrodes on two straight probes.

• The electrodes are internally cooled allowing deep, even heating and eliminating tissue adherence.

• Temperature sensors allow monitoring at the electrode tips and disc periphery.

• Heating parameters can be adjusted to achieve a specific thermal dose.

cooled

Tip Temperature

Peripheral Temperature


Transdiscal Bipolar RF Disc Treatment

Heating Profile

• The ideal temperature profile is 55°C in the inner posterior disc decreasing to 45°C in the peripheral edge of the posterior disc.

Temperature vs Distance

Therapeutic Zone

Probe Probe

35

40

45

50

55

30


Initial Introducer Placement


Lateral View- Electrode Position


Anterior-Posterior View


Cleveland Clinic Cadaver Study


Cleveland Clinic Cadaver Study

Disc ArrayDisc 1Disc 2Disc 3

NF ArrayNF 1NF 2NF 3

Epidural ArrayEpidural 1Epidural 2Epidural 3Epidural 4


In vivo porcine safety study

Temperatures monitoring at designated safety zones outside the disc demonstrated maintenance of near-physiologic conditions while

temperature across the posterior annuls reached 65°C1

1 Petersohn J et al. Pain Medicine; 2007: (In Press)


Cleveland Clinic Pilot Study

• Primary Investigator: Dr. Leo Kapural• Consent and approval by IRB-15 patients• Previously denied IDET• MRI and discography within 12 months

• Two patients out of the study, 13 followed


Results

• Notice the rapid decline in pain scores and improvement in function

• In most cases almost a week later!

0 1 3 6

510

1520

2530

Oswestry

Time (Months)

Osw

estr

y S

core

0 1 3 6

2030

4050

6070

8090

SF-36 Physical Functionality

Time (Months)

SF

-36

PF

Sco

re

0 1 3 6

2040

6080

SF-36 Bodily Pain

Time (Months)

SF

-36

BP

Sco

re

0 1 3 6

02

46

810

VAS Pain

Time (Months)

VA

S P

ain

Sco

re

0 1 3 6

050

100

150

Opioid Use

Time (Months)

Opi

oid

Use


Significant declines in functional and VAS but not did not reach statistical decline in opioid use

25th Median 75thBaseline 23.3 7.0 17 25 29

1 16.5 6.8 11 15 203 16.9 7.1 13 16 226 17.1 8.1 13 18 24

Baseline 50.8 17.5 40 55 601 59.4 13.0 50 55 673 65.7 14.4 50 70 756 69.9 16.2 55 70 80

Baseline 37.5 15.0 33 35 451 49.7 19.3 33 45 653 51.2 16.8 45 45 586 53.8 22.7 45 58 68

Baseline 7.2 1.9 6 7 81 3.3 2.1 2 4 53 3.8 1.9 3 4 56 3.4 1.9 2 3 5

Baseline 73.5 59.7 40 40 1201 56.5 62.6 0 40 803 45.0 59.2 0 40 406 38.8 61.6 0 5 40

VAS Pain Score

Opioid Use

Quantiles

Oswestry Score

SF-36 PF Score

SF-36 BP Score

Response Variable

Time (months)

MeanStandard Deviation


Pain Management SInergy TM System

For effective denervation in the treatment of SIJ Syndrome


SI Joint Innervation

Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007.

S1 S3S2


• Joint is predominantly, innervated by posterior primary rami1,3,4

• Nerve location is variable: 2,5

– Person to Person– Side to Side– Level to Level

• Nerves may run along bone, or up to 8 mm superficial from the sacrum 5

SI Joint Innervation

Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007.

1Cohen S. Anesth Analg. 2005: 101: 1440-1453; 2Yin W. et al. Spine. 2003; 28(20):2419-24253Grob K. et al. Z Rheumatol. 1995;27:117-122; 4Fortin J. et al. Spine. 1994;19(13):1475-14825Willard F. et al. World Congress on Low Back and Pelvic Pain. Vienna, Austria, 1998


Diagnosis

• Referral Zones• Screening Exam:

– Best PPV (60%)10, 11 Maximum pain below L5 coupled with pointing to the PSIS or local tenderness just medial to the PSIS has the

– Distraction Tests limited utility

• Imaging: Little value• Intra articular blocks gold

standard?• There is a 37-66% occurrence of

False positive responses from the first injection (22% FP rate)6,12

Fortin. Spine 1994; 19:1475-1482

Sacral Sulcus Tenderness

Buttocks 94%Lower lumbar 72%LE 50%Groin 14%Slipman C 1998

10 Dreyfuss P, Spine 1996; 21:2594-2602, 11 Slipman C, Arch Phys Med Rehabil, 1998; 79:288-92 6 Maigne, Spine 1996, 21:1889-1892, 12 Manchikanti. Pain Physician 4:308-316, 2001


Sacroiliac RF Lesion Requirements

• Level L5– Lesion the primary

dorsal ramus at sacral ala

• Level S1, S2, S3– Lesion all lateral

branches as they exit foramen


Cooled RF Lesions

SACRAL SURFACE

Isotherm MapWhite meat tests comparing SInergy

probe and Standard RF

10 mm

3.5 mm


Physics of Cooled RF Lesions

Non-cooledCooled

Temperature

Distance

80° C

45° C r

• Without cooling, the size of lesion is limited by the heat generated in the tissue adjacent to the electrode

• Cooling the tissue adjacent to the electrode allows effective heating at a greater distance


Perpendicular & Oblique Placement

Spherical lesion shape allows for perpendicular or oblique probe placement near the treatment site.


Electrode Placement

• Spinal needles are used to mark the PSFA

• Introducer and electrode are directed “down the beam” towards the target anatomy

• Electrode is positioned 7-10mm from the PSFA for safety

Image provided courtesy of Dr. Robert E. Wright, Denver Pain Management


Effective Lateral Branch Ablation

• Anatomical studies provide guidance on lateral branch location

• Cooled RF technology allows for controlled and repeatable large volume lesions

• This allows for the effective ablation of lateral branch nerves in the treatment of sacroiliac joint syndrome


SInergyTM System Clinical Outcomes

Prospective Cohort Study by Dr. Robert Wright

• (n = 15, baseline VAS = 7)• >50 % reduction in VAS considered success

PRE OP 3 MONTHS 6 MONTHS

% Responders N/A 73%(11/15)

66%(10/15)

Avg. VAS 7.0 2.4(66% less)

2.9(59% less)

Opioid Use 8 x LA5 x SA2 x none

5 x LA4 x SA6 x none

3 x LA5 x SA7 x none


SInergyTM System Clinical Outcomes

Placebo Controlled Study by Dr. Steven Cohen• 28 patients randomized to RF or sham denervation of L4-S3 • Strict success criteria:

– >50% VAS reduction AND – Positive GPE (Global Perceived Effect) AND

– >10 point ODI improvement

• 6 month follow-up complete with strong results. • Data Release Pending publication in 2007

Download - clique para assistir

Top Related