Milestones in herniated disc treatment: Chemonucleolysis 1963

Eugene Jansen and Arnold Ball isolated Chemypapain, a protelyc enzyme, extracted from papaya latex 1941. In 1956, Lewis Thomas injected chemopapain into the ears of a rabitt and recognized that they dropped because the cartilage was decomposed by the chemical substance and lost their hold function.
1963 injected Lyam W. Smith, an orthopedic surgeon and simultaneously owner of Smith Laboratories for the first time Chemypapain between two vertebrae by the posterolateral approach, described by Ottolenghi and Craig for biopsy. Smith called this method "Chemonucleolysis". The chemical substance has been registrated by Smith Laboratories under US. Patent No. 3,320.131 and produced and distributed through Baxter-Travenol Laboratories, Deerfield/Illionois.

Chemical process:

Chemypapain alters the characteristics of the nucleus pulposus by liberation of condroitin sulfate and keratin sulfate by hydrolysis of non collagenous proteins of muscopolysaccharide involvment and leading to polymerization of nucleus pulposus.

Goal of Chemonucleolysis:

The shrinkage of the gelatinous mass within the disc caused by Chemypapain leads to a pressure reduction within the disc and the sinking of the bulging of the anulus fibrosus. Thus reduces the pressure relief of the affected nerve root. Therefore the result is called intradiscal decompression.

Approach and operation technique:

Access path and surgical technique draw on experiences of the intervertebral disc biopsy of Ottolenghi and Craig. The patient is placed either lateral or prone position. By the postero lateral access to the foramen intervertebralis a guidewire is inserted to the center of the disc under bi-planar x-ray control. Subsequently the injection needel is pulled over the guidwire and pushed forward to its tip . The guidewire is removed and by a syringe Chemypapain is injected into the disc. The access diameter is only 2 mm and the opening of the disc closes shortly aterwards.

Necessary technical equipment: X-ray C-arm:

The launch of mobile x-ray device with x-ray and image intensifier technology for bi-planar images by Siemens 1963 with Siretom X-ray C-arm had considerble influence for spreading of biopsy and spinal disc treatment. The safe positioning of guide wire and injection needle is still crucial of a successfull treatment by the posterolateral access to the intervertebral foramen. It is no coincidence that the development of X-ray C-arm machine and the treatment of the disc by the posterolateral access coincide. The development of mobile X-ray C-arm equipment is subject to ongoing changes and improvements to the current state of the art as a mobile 3D robot X-ray machine.

Scientific Documentation:

Smith published his first experiences with Chemonucleolysis in "Journal Of American Medical Association" (JAMA). Subsequently 75 surgeons in the USA and Canada treated 17,000 patients and reported success rates of 83%
According to the study of 104 veterans with herniated disc by the neurosurgeon Bernard J. Sussmann (Walter Reed Military Hospital Washington) who came to a different conclusion the use of Chemypapain for the treatment of herniated discs was eliminated by the FDA within USA in 1975. In Canada, Switzerland and Germany Chemypapain was continously market by Travenol and Chemonucleolysis continue to apply. Many physicians worldwide are still convienced that the treatment is safe, successfull and costeffective and published numerous scientific papers about this operation technique. It is suitable only for treatment of protrusions, as the chemical substance must not leak out of the disc which would happen by treatment of extruded gelatine mass with demaged Anulus Fibrosis.

Complications:

Neurologic transverse myelitis ( Agre 1984, Daniel 1985), allergic reaction (Nietsck et al. 1986, Sutton 1986, Bouillet 1987) back pain after injection (Hedtmann et al. 1986, Bouillet 1987), instability ( Steffen 1993)

Conclusion:

Treatment of disc protrusion by Chemonucleolysis is controversial. Much physicians prefer conservative treatments.Ultimately, today the well-informed patient is involved in the process of decission what kind of treatment will be applyed, while the duration of healing is an important factor related to his profession and living conditiones.

Anyway Chemonucleolysis as a minimally invasive surgery was a first alternate to open surgery by laminectomy and is therefore a milestone in historical prolapsed disc treatment.

Sources: 

Lyam W. Smith, Chemonucleoysis "Journal of American Medical Association" (1963)

Endoscopic Spine Surgery and Instrumentation, Historical Background of Minimally Invasive Spine Surgery, Mick J. Perez-Cruet, Raju S.V, Balbhadra, Dino Samartzis, Daniel H. Kim, S 3-18, Thieme Verlag (Hsg: Kim, Fessler, Regan) ISBN: 1-58890-225-0

US Patent No: 3,320.131

Bandscheibenbedingte Erkrankungen, Krämer, Matussek, Theodoridis, Thiemeverlag
ISBN: 978-3-13-176166-8

Leu H.J., Panoussolopulous A., Schreiber A., Chemonukleolyse, Perkutane Technik und Laser Technik bei Bandscheibenvorfall in Dahmen G. (Hsg.) Tiefsitzender Rückenschmerz, Verlag CIBA-Geigy, Reihe Reumatologie-Orthopädie Wehr (BRD) 1994, S 49-59

Schreiber, Suezawa, Leu: Therapie des Bandscheibenvorfalls: Chemonucleolyse vs. perkutane Nukleotomie DMW 13 (1988) 1482-1485

Röntgenbasierte Bildgebung mittels robortisierten C-Bogen. Inauguraldissertation: Dipl. Inf. Christoph Bodensteiner, Lübeck, Juni 2009, Instit für Robotik und kongitive Systeme, Direktor Prof. Dr. Ing. Achim Schweikhart

Origin of minimally invasive operation techniques

Origin of minimally invasive operation technique is endoscopy because of avoiding larg cuts. Endoscopy became reality with development of the light conductor by Philipp Bozzini, 1806. Magnifying of the operation field to get detailed informations about tissue structures and pathology was one requriement and this have been solved by the use of lens systems. Over the centuries knowledge in optical calculation and precise lens production grew by several milestones till it reached todays quality standard.

The progress in Minimally Invasive Surgery (M.I.S.) is influenced by much more factors than endoscopy. Between the early 1960s and late 1970s medical innovations reached new dimensions.

• Imaging systems like CT and MRI brought progress to patient diagnosis
• Imaging systems for surgery like advanced Endoscopes and Operation Micoroscopes opened new possibilities of patient treatment because of magnifying the operation field. In the case of Microscopy in three dimensions.
• Devices used in combination with imaging systems like insufflation, fluid- and irrigation systems, video-systems, shaver and drill devices.
• Development of indication relatated specific surgical instruments, combined with quality progress of production by CNC-machining centers.
• Beginning of integration of information technology in patient treatment processes

But all these inventions are only useful in the hands of responsible surgeons, which guided the technical developments, articulated by their anatomical and treatment experiences, in the right direction. They extended interventions, but applying considered and recognized the limitations of the range of indications. This approach is still valid today.

Milestones in Medical History

Mile Stone Definition

A milestone is erected at regular intervals along roads as distance indicator. In Medical History a milestone is a turning point in the development process of patients treatment.

Never in History a single idea created a mileston. In Medicine it is the competent transformation of this idea in an advanced operation technique, combined with adaequate (in most cases new designed) devices. A mile stone operation technique is accepted and practiced by the main part of surgeons around the globe. It is clear ahead to former treatment and becomes therefore "The Gold Standard" till it is replaced by a better one.

10 Rules to identify a milestone in Medicine

1. How can I do better than before?
2. What will be the goal of the action?

• less trauma of the access
• less pain and certain heeling for the patient and fast recovery
• safe operation technique
• less morbity, shorten operation time

3. What has to be changed in equipment?

• precise description and specification of necessary new development
• Qualification of the producer of devices (experience, workmanship, machinery) 

4. Step by Step explanation of the operation technique, advanteges against actual "Gold Standard", combined with advantages of new developed devices.

5. Concept for reduction of time consuming learning curve (text book with "tips and tricks", workshops, hospitations)

6. Supporters concept (own team, engineers, manufacturers, scientific societies)

7. Launch of Methode and Material

8. Number of Conferences, Workshops, Hospitaions and Publications

9. Action radius (local, Europe, World Wide)

10. Cooperation to spread the medical milestone concept with leading surgeons around the globe

History of prolapsed disc treatment: Volume 2

The posterolateral approach to the spine

 The basis for the treatment of herniated discs through the posterolateral access to the foramen intervertebralis was created by needles gather tissue material from the disc by biopsy. This approach was described for the first time in 1955 by Professor Ottolenghi, an Orthopedist from Buenos Aires.

                                                                Professor Ottolenghi

Biopsy of bone material for the diagnosis of tumors was performed by Mixter 1922, Ward and Fokner 1927. Robertson and Ball devised a technique of vertebral needle biopsy in 1935. The development of a thin Trephine by Siffert and Artkin improved biopsy of bone tumors significantly in 1949.

In 1955 Ottolenghi gathered tissue material of vertebrae using longer and finer biopsy needles and trephines, which he developed especially for this purpose. Related to their dimensions they allowed the postero lateral (tissue protecting) approach to the spine. This approach is still used till today. The break through for this approach came with image guided systems like c-arm x-ray and CT.

Source:
Aspiration Biopsy of the spine / Ottolenghi: J.Bone Jt Surg 51 A 1531 - 1544 (1969)
Closed Vertebral Biopsy, I.S. Fyee, A.P.J. Henry, R.C. Mulholland, 1983, British Editorial Society, Bone and Joint surgery 0301-620X/83/2021-140
Magerl F, Witzmann A, Komplikationen dorsaler Zugänge zur Lendenwirbelsäule und deren Verhütung: Der submuskuläre Zugang. Trauma Berufskrankh 2005-7 (Suppl 2) 292-298

Material:
The technical development of the application of biopsy gegann with the invention of hollow needle and syringe.
1713 the french eye doctor D. Anela used a lachrymal silver syringe, similar to todays models.
1817 the German surgeon Graefe introduced a trocar (trois quarts) with a triangular cut needle surrounded by a hollow needle for puncture into the vein.
1836 The Lyoner Doctor C.G. Pravaz developed together with the French manufacturer J.F. Charriere  also a syringe. The medication dosage was controlled by means of screw thread. Later a stamp was used instead of a screw thread, which is used till today.

1844 Scottish doctor A. Wood and docotor F. Rynd treated neuralgic pain with subcutaneous morphine liquids. The syringe was produced by the London instrument maker D. Ferguson. Ferguson developed the first glass syringe ago with graduated glass cylinder.

1860 The french instrument maker G.G.A.Lüer developed a syringe to which the needle is plugged. This principle is applied in addition to the record-bit on top until today.

Source:
Buess H., Zur Frühgeschichte der intravenösen Injection CIBA-Zeitschrift 9, (1946) 3594-3606
Price J. Dominique Anel and the small lachrymal syringe. Medical History 13 (1969) 340-354
Buess H, Die Entwicklung der subkutanen und intramuskulären Injektion, CIBA Zeitschrift 9 (1946) 3628-3635
Howard-Jones.N: A critical study of the origins and early development of hypodermic medication, Journal of History on Medicine and Allied Sciences 2 (1960), 201-249
Blake, J.B.: Ferguson´s hypodermic syringe. Journal of History of Medicine and Allied Sciences 15 (1960) 337 - 341

The technology of production of injection needles and syringes for medication and biopsy has been developed rapidly like all medical areas within the last fifty years. Cut shapes and special cannulas are used for different types of biopsy. These include fine biopsy, vacuum biopsy and forceps biopsy often associated with endoscopy.
A pioneer in the field of bone marrow aspirate was the Persians Ali Akbar Djamshidi. He is the originator of the jam-shidi puncture needle which is produced by many manufacturers and very well known by orthopedists and trauma surgeons around the globe.

Prolapsed disc treatment

From the roots to the fruits: Milestones in Treatment of Prolapsed Disc

Treatment of herniated discs took his output at the beginning of the 1900s. The aim of any treatment is to find an access to the pathogenic tissue, which will reduce surrounding tissue demage in order to find a better healing process. It is a long way from the first open surgery in disc treatment to minimally invasive operation techniques that are applied today. This path is marked by milestones that have been devised by surgeons using the technological advances in medicine. The milestones are summerized in the sequence, wherein each milestone is written as an article and published as a post in "Endoscopic History"

                                         

• Laminectomy performed by Mixter and Barr 1934
• Postereor Cervical disc surgery performed by Spurling and Coville 1944 
• Cervical Discectomy via anterior approach since 1950
• Biopsie of disc material performed by Argentina 1955 and Craig 1956 
• Chemopapain injected and discribed by Smith et al.  using the posterolateral approach 1963
• Microdiscectomy performed and published by Caspar / Yasargil using a microscope for visualization 1975
• Percutaneous Nucleotomy discribed and performed by Hijikata using the posterolateral approach 1975
• Introdution of Percutaneous Nucleotomy in Europe by Schreiber, Leu, Suezawa 1978
• Endoscopic Assisted Percutaneous Nucleotomy by Schreiber, Leu 1979
• Development of SB-Charité lumbar disc Implant by Karin-Büttner Janz 1984
• Percutaneous Laser Disc Decompression performed and published by Choy 1985
• Development of legentary Minicamera MC-103 by Norbert Lemke as OEM producer for Karl Storz which influenced all endoscopic procedures since 1986 because visualization chanched from direct viewing through an Endoscope to permanent monitor contol.
• Epiduroscopy with a 2.3 mm Micro Endoscope with working channel and angulation of the tip, published by Stoll, Watkins, Mathews 1989
• Thoracic endoscopic acess to the spine by Mack, J.J. Regan, Rosenthal 1990
• Biportal Approach to the spinal canal discribed and performed by Schreiber, Leu 1991
• Foraminoscopy Presented by Hal Mathews at San Francisco Conference using a special designed Scope of  Danek Inc. 1991
• Foraminoscopy presented by Schreiber, Leu using a special designed Scope of Karl Storz for treatment of lumbar extraforaminal herniations1991
• Laparoscopic discectomy published by Obenchain 1991
• Enlargment of Foramen intervertebralis with reamers and special designed instruments for removal of lumbar median, paramedian and foraminal disc herniations and treatment of stenotic foramen under C-Arm control by Thomas Hoogland 1996
• Advanced Foraminoscopy with new designed Foraminoscope in combination with spezialized instruments instruments for lumbar median, paramedian and foraminal disc herniations and treatment of stenotic foramen by full endoscopic visualization performed by T. Hoogland 1998.
• MED Tubular System for microdiscectomy, laminotomy, laminectomy and spinal canal stenosis published by Kevin T. Foley and Medtronic sofamor Danek 1998
• Cervical Endoscopic Ventral Approach by Sang Ho Lee and John C.Chiu since 1998.
  
  

History of prolapsed disc treatment

Laminectomy

Knowledge of the lumbar herniated disc as a common cause of sciata is due William Jason MIXTER (1880 - 1958) and Joseph Seaton BARR (1901 - 1963) On September 30, 1933, the authors working at the Massachusetts General Hospital in Boston refered about  "Ruptures of the interverebral disc with involvement of the spinal canal". When etiting their 25 cases of "spinal cord tumors" they succeeded 19 times the histological detection of nucleus pulposus or anulus fibrosus and only 6 times found themselves cartilaginous or unclussifiable tumors.

Excerpt from the lecture of 1933

That, not an uncommon cause of symptoms is the herniation of the nucleus pulposus into the spinal canal or the rupture of the intervertebral disc, as we call them preferably.  The fact that the lesion was often misunderstood as cartlaginous, emananting from intervertebral disc regeneration.That in reality the rupture of the intervertebral disc ist much more commen than the neoplasia, the treatment of this disease is in our series in the 3 to 1 ratio... it is a surgical one and that the results obtained, provided that the compression was not to long, are very satisfactory".

(Mixter WJ, Barr JS (1934) Rupture of the intervertebral disc with involvement of the spinal canal. New Engl. J Med 211:210-215)

Early Operation techniques by Krause

The first actual operations of lumbar disc herniation were made in the early 1900s, the herniated discs still were called "Ekchondrome" or " Ekchondroma"also "cartilaginous tumors"

.

The type of surgical technique semms from todays´perspective adventurous (Krause 1911): Macro Surgical, so to the naked eye, the dura mater was slit-shaped opened, the cerebrospinal fluid was drained, then the intradural space was inspected, then the front of the Dura opened, and then the herniated disc was removed.

The patient, described by Krause had so far recovered from the surgery that he could lead a normal life 10 month after surgery. What remained was Peroneuspararese which could however, have also existed prior to the OP (Literature: Krause 1911, pp 717 - 719)

Operation technique by Mixter - Barr

For the laminectomy a skin incision above the center line of the spinous process is performed. The cout continous through the supraspinous ligament up to the tips of the spinous processes. There after, the spinal straps are removed, after that the lateral muscle packages are peeled off by chisel or rasp and also the lateral muscels till to the angle joints The muscels are held by a retractor aside and the spinous process is removed with a Luer forceps. Subsequently, the vertebral arches are detached with a laminectomy punch. Through removal of the spinous process and the arch the underlaying nerve was released. This operation technique has been used, with variations, till the end of the sixities last century for prolapsed disc treatment. Nowadays laminectomy is used mainly for tumors and severe spinal stenosis. Prolapsed disc is treated with more advanced operations techniques.

              

Minimally invasive spinal disc treatment

Classification of proapsed spinal disc.

by intensity: Protrusion, Herniation, Sequester

by exit of the prolapsed disc: median, paramedian, foraminal, extraforaminal

by level of the prolapsed disk, cervical, thoracal, lumbal

The different prolapsed disks related to intensitiy, exit of prolaps and level require the determination of the optimized access path, operation technique as well as the appropriate instruments.

Minimally invasive disc treatment

Introduction

Herniated disc are a common musculosketeral disorder that is affected on the one hand by continuing pain and on the other hand the disease considerably restricts the living conditions. This disorder can lead to withdrawal from professional life.

The cause is the leakage of gelatinous mass from the interior of the vertebral disc. Depending on the point where the material exits, it compresses the spinal cord, the nerve root or the exiting spinal nerve, often under servere pain.As a result, it can lead to paralysis of the areas, which supplies the nerve concerned.
The exiting material has only a volume of a few cc. The problem to remedy this defect is located in the access route. The herniated disc is on one hand surrounded by sensitive structures, like spinal cord, nerves, blood vessels, ligaments and muscles, and on the other hand from a stable skeleton. This carries half of the body but also protects the neural structures.

The herniated disc occurs in very different forms, therefore the successfull treatment requires extensive preliminary investigations. These include investigations with MRI, CT and X-ray. If it is decided that after 3-6 month of unsuccessfull conservative treatment, surgery is necessary, it requires a competent surgical planning. Intensity (Protrusion, Herniation, Sequester) Level (Lumbal, thoracal, cervical) and Position (median, paramedian, foraminal, extraforaminal) have to be located and recorded. The combination of different herniated disc options by position, intensity and level require the determination of the optimized access path, the method of operation as well as the appropriate instruments.