4,573,448
`[11] Patent Number:
`[19]
`United States Patent
`
`
`[45] Date of Patent:Kambin Mar. 4, 1986m
`
`[54] METHOD FOR DECOMPRESSING
`HERNIATED INTERVERTEBRAL DISCS
`
`Parviz Kambin, Devon, Pa.
`Inventor:
`[75]
`Pilling Co., Fort Washington, Pa.
`[73] Assignee:
`[21] Appl- No.: 539 256
`.
`’
`[22] Flledi
`OCt- 5, 1933
`[51]
`Int. Cl.4 ........................ A61F 17/32; A61F 5/04;
`A61B 17/16
`[52] US. Cl. ................................. 128/1 R; 128/305.1;
`128/310; 128/92 E; 128/92 EB
`[58] Field of Search .................... 128/1 R, 305, 305.1,
`128/310, 303 R, 329 R, 341, 343, 328, 356, 92
`E, 92 EB, 749-754, 769, 770; 604/22
`References Cited
`U'S' PATENT DOCUMENTS
`1,867,624 7/1932 Hoffman ............................. 128/305
`
`2,850,007 9/1978 Lingley -----------
`123/305
`3,330,278
`7/1967 Santomieri ------
`°~ 128/305
`3,848,601 11/1974 Ma etal. .........
`3.. 128/305
`
`3,964,468
`6/1976 Schulz .........
`128/305
`
`3,995,619 12/1976 Glatzer ................. 128/305
`4,203,444 5/1980 Bonnell et al.
`...................... 128/305
`
`[56]
`
`4,246,902
`1/1981 Martinez ............................. 128/305
`4,320,761
`3/1982 Haddad ...............
`.. 128/305
`4,337,773
`7/1982 Raftopoulos et al.
`1.. 128/305
`
`4,444,184 4/1984 Oretorp ...............
`128/305
`
`. ........ 128/305
`4,461,281
`6/1977 Carson .....
`Primary Examiner—Robert Peshock
`Assistant Examiner—C. W. Shedd
`Attorney, Agent, or Firm—Howson and Howson
`5
`ABSTRACT
`[ 7]
`Decompression of herniated discs in the lumbar Spine is
`carried percutaneously by the insertion of a specially
`designed cannulated trocar over a guide wire extending
`through the patient’s back toward the herniated disc at
`an angle of approximately 35 degrees with respect to
`the patient’s perpendicular line. A thin-walled cannula
`is passed over the trocar, and a hollow cutting instru-
`ment is inserted through the cannula to form a window
`in the disc. Disc fragments are removed through the
`cannula by means of a special punch forceps, after the
`application of suction to the disc nucleus through the
`.
`.
`cuttmg msm‘ment'
`
`11 Claims, 10 Drawing Figures
`
` 1
`
`NUVASIVE 1013
`
`1
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`

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`US Patent Mar. 4, 1986
`
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`US. Patent Mar. 4,1986
`
`Sheet20f2
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`4,573,448
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`3
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`1
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`4,573,448
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`METHOD FOR DECOMPRESSING HERNIATED
`INTERVERTEBRAL DISCS
`
`BRIEF SUMMARY OF THE INVENTION
`
`This invention relates to surgery and specifically to a
`novel method for decompressing herniated interverte-
`bral discs in the lumbar region of a human patient.
`Low back pain syndrome with sciatica secondary to
`herniated intervertebral discs represents a major health
`probelm in the United States. An intervertebral disc is a
`structure which occupies the space between the verte-
`brae. A normal disc consists of two parts: a central part
`known as the “nucleus”, and a surrounding part known
`as the “annulus” or “annulus fibrosis”. The annulus
`degenerates with age, as does the nucleus. Degeneration
`of the annulus is characterized by the formation of cir-
`cumferential tears in the annulus. Degeneration of the
`nucleus, which is initially in the nature of a colloidal gel,
`is characterized by collagenation, in which some of the
`fluid content of the nucleus is lost and fragments of
`collagenized fibrous tissue are formed which float in the
`tissue fluid. At this stage of degeneration, external
`forces can readily increase the hydrostatic pressure on
`the nucleus, causing the fibers of the annulus to rupture.
`Nucleus fragments protrude. This, in turn, may cause
`pressure on the adjacent nerve root with resultant pain.
`Several methods of treatment already exist. One
`method, usually referred to as “laminectomy”, involves
`the surgical excision of the herniated disc. Laminec-
`tomy is carried out by making an incision in the lower
`part of the spine for posterior exposure, separating' the
`muscle from the bone, removing a portion of the verte-
`bra, visualizing a portion of the nerve root, and surgi—
`cally removing disc material. This method of treatment
`has been in use for nearly fifty years. Typical hospital-
`ization time is around nine days. Recently, microsur-
`gery has been used in the treatment of herniated discs, in
`a procedure known as “microlumbar discectomy”. The
`microsurgical procedure, because it also involves poste-
`rior exposure, carries with it many of the complications
`associated with the older procedure, including injury to
`the nerve root and dural sac, perineural scar formation,
`reherniation at the site of the surgery, and instability
`due to excess bone removal.
`is known as
`Another recent method of treatment
`chemonucleolysis, which is carried out by injection of
`the enzyme chymopapain into the disc structure.
`Chemonucleolysis, unfortunately, has many complica-
`tions including severe pain and spasm, which may last
`up to several weeks following the injection. Sensitivity
`reactions and anaphylactic shock occur in limited but
`significant numbers of patients, and the death rate is
`around 0.5%. Other effects include disc space narrow-
`ing, requiring further treatment, and leakage of chymo-
`papain into the subarachnoid space with damage to the
`thin wall vessels.
`
`The principal object of this invention is to provide a
`relatively safe method for treatment of herniated discs
`which avoids the above-described complications and
`dangers of conventional
`surgical
`treatments
`and
`chemonucleolysis. It is also an object of the invention to
`provide a method of treatment which has the advan-
`tages of low post-operative morbidity, elimination of
`epidural bleeding, elimination of problems associated
`with rehemiation, and the elimination of structural in-
`stability due to excess bone removal. It is also an object
`of the invention to eliminate the need for lengthy sur-
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`gery in a large number of cases and to provide a cost-ef-
`fective procedure for treatment of herniated discs.
`The method in accordance with the invention may be
`carried out under local anesthesia, thus avoiding the risk
`of general anesthetics. In accordance with the method,
`a conventional hollow needle with a stylet is inserted
`through the skin of the patient’s back at a location
`spaced from the midline. The needle is advanced in an
`oblique direction, preferably at an angle of approxi-
`mately 35 degrees with respect to a line perpendicular
`to the patient’s back, until it reaches the outside of the
`annulus fibrosis of the herniated disc. The stylet is then
`withdrawn, and a guide wire is introduced through the
`needle to the disc. The needle is then withdrawn, while
`the guide wire is held in place. A cannulated, blunt—tip
`trocar is passed over the guide wire until the tip reaches
`the outside of the annulus. The guide wire is then with-
`drawn. A thin-walled cannula, which closely fits over
`the trocar, is passed over the trocar until its distal end
`reaches the outside of the annulus. The trocar may then
`be withdrawn, and a cutting instrument inserted. The
`cutting instrument comprises a hollow circular cylindri-
`cal tube having cutting teeth formed in a circular con-
`figuration at its distal end. A window is formed in the
`herniated disc by rotary manipulation of the cutting
`instrument. Fragments of the herniated disc are re-
`moved through the cannula by either or both of two
`methods. In accordance with one method, suction is
`applied to the cutting instrument for the removal of disc
`fragments. The cutting instrument may be moved back
`and forth within the nucleus of the herniated disc as
`suction is applied. Alternatively, suction may be applied
`through the cannula itself. The second method is the
`insertion of punch forceps into the nucleus of the disc
`through the cannula.
`As the foregoing procedures are carried out under
`local anesthesia, the assistance of the patient is available
`to assess the degree of pain relief following the removal
`of disc fragments. The foregoing procedures are radio-
`graphically monitored using an image intensifier. Local
`anesthetic can be introduced through the needle, the
`trocar, the cannula, and even through the cutting instru-
`ment. Special attachments are provided for introduc-
`tion of anesthetic through the trocar and cannula.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is an elevational view of a needle used in
`accordance with the invention;
`FIG. 2 is an elevational view of a stylet for the needle
`of FIG. 1;
`FIG. 3 is an elevational view of a guide wire or
`“Kirschner wire” used for guiding the trocar;
`FIG. 4 is a partially broken away elevational view of
`the trocar;
`FIG. 5 is an elevational view of an anesthetic adapter
`for the trocar;
`FIG. 6 is a longitudinal section through a thin-walled
`cannula in accordance with the invention;
`FIG. 7 is an elevational view of a suction adapter for
`the cannula;
`FIG. 8 is a partially broken away elevational view of
`the cutting instrument;
`FIG. 9 is an elevational view of a punch forceps used
`in accordance with the invention; and
`FIG. 10 is a sectional view through the spinal column
`of a patient, showing the cannula in place, and the cut-
`
`4
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`

`

`4,573,448
`
`3
`ting instrument extending through the cannula into the
`nucleus of the patient’s herniated disc.
`DETAILED DESCRIPTION
`
`FIG. 1 shows a needle 12 having a Luer lock fitting
`14 at its proximal end for the introduction of a local
`anesthetic. The needle is a hollow, bevelled needle,
`typically having an external diameter of 0.050 inch and
`an internal diameter of about 0.038 inch. The bevel is
`about 23 degrees, and the length of the needle is approx-
`imately 6 inches. The needle is provided with a stylet
`16, as shown in FIG. 2. The stylet is typically about 6%
`inches in length, and has an external diameter of just
`under 0.038 inch, so that it fits within the interior of
`needle 12.
`
`FIG. 3 shows a guide wire 18, which is typically
`about 9 inches in length, and about 0.026 inches in diam-
`eter. It has pointed ends. This wire is used to guide a
`special trocar toward the site of the disc.
`A trocar 20, as shown in FIG. 4 has a blunt tip 21, and
`has a narrow passage 22 extending from the tip and
`meeting a larger passage 24 which extends to the proxi-
`mal end. The exterior of the proximal end is threaded at
`26 to receive an adapter 28 (FIG. 5), having a Luer lock
`fitting 30. This adapter is used for the introduction of
`anesthetic as the trocar is introduced. The trocar is
`
`preferably approximately 0.198 inches in diameter. Pas-
`sage 22 is slightly greater in diameter than the diameter
`of the guide wire 18, so that it can be guided easily over
`the guide wire. Preferably, passage 22 is about 0.050
`inch in diameter.
`The thin-walled cannula 32, as shown in FIG. 6 has a
`threaded proximal end 34 which receives an adapter 36
`(FIG. 7) having a Luer lock fitting 38. The adapter of
`FIG. 7 is similar to the adapter of FIG. 5 except for the
`size of its internal threads. It is used for the application
`of suction for aspiration of disc fragments through the
`cannula.
`
`The exterior of the cannula is approximately 0.250
`inch in diameter, while the interior is at least approxi-
`mately 0.200 inch in diameter, i.e. slightly greater than
`the external diameter of the trocar of FIG. 4. Thus, the
`cannula closely fits the trocar, and can be inserted over
`the trocar, while the trocar is in place with its tip in
`contact with the exterior of the disc which is to be
`decompressed.
`The cutting instrument of FIG. 8 comprises a hollow
`cylindrical
`tubular part 40 having saw-like teeth 42
`arranged in a circular configuration at its distal end. The
`proximal end of the instrument is provided with a grip
`44 which is used to apply a twisting motion to the in-
`strument. The cutting instrument is hollow throughout,
`and is provided with a Luer lock fitting 46 at its proxi-
`mal end for the attachment of a suction apparatus for
`aspiration of disc fragments through the cutting instru-
`ment.
`
`The forceps of FIG. 9 are similar to a conventional
`punch forceps, and comprise an elongated tube 48, and
`jaws 50 which are controlled by manipulation of handle
`elements 52 and 54. Handle element 52 controls a rod
`which extends through tube 48 and effects pivoting
`motion of the upper jaw of jaws 50. The size of the
`tubular member and of the jaws in FIG. 9 are such as to
`permit insertion through cannula 32 of FIG. 6 into the
`nucleus of the disc through the window formed by the
`cutting instrument of FIG. 8.
`In the procedure in accordance with the invention,
`the patient is placed in a prone position, and two rolled
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`sheets which extend from ileum to the chest are placed .
`under the patient to maintain the patient’s hips in flexion
`to prevent undue pressure on the abdomen and to re-
`duce tension on the sciatic nerve. The patient’s knees
`are also kept in flexion by extra supports under the legs.
`This position is used to minimize movement of the pa-
`tient during the procedure and to maintain the patient as
`comfortable as possible.
`The operation is carried out under continuous radio-
`graphic monitoring using a C-arm image intensifier.
`The lumbar area is prepared and draped in the usual
`manner, and anesthesia is induced by local infiltration of
`a 0.5% Xylocaine solution.
`The skin is punctured about 3.5 to 4 inches from the
`midline by needle 12 with stylet 16 in place within the
`needle. The needle is introduced from the side in which
`radicular pain and neurologic deficit are present. The
`needle is inserted at an angle of approximately 35 de-
`grees with respect to a line perpendicular to a patient’s
`back. The transverse process is bypassed, and the needle
`is advanced to the intervertebral disc space. The needle
`can be redirected if radicular pain is encountered.
`When the needle is correctly positioned and in
`contact with the exterior of the disc, stylet 16 is with-
`drawn and replaced with guide wire 18. The needle is
`then withdrawn while the guide wire is held in place.
`The trocar 20 of FIG. 4 is then passed over the guide
`wire with a twisting motion until it reaches the location
`of the exterior of the annulus. Xylocaine may be intro-
`duced through the trocar as needed, using the adapter
`of FIG. 5.
`
`The use of a guide wire together with a cannulated
`trocar is particularly important to the success of this
`procedure because of the large diameter of the trocar
`(typically 0.198 inch) dictated by the necessarily large
`internal diameter (typically 0.200 inch) of the thin-
`walled cannula. Because of the large diameter of the
`trocar, it is very important that it be guided properly to
`avoid irreversible nerve damage.
`After the trocar is properly positioned, the guide wire
`is removed, and cannula 32 is passed over the trocar.
`When the cannula is in place, it is held firmly against the
`annulus to prevent it from slipping. The trocar is then
`withdrawn, and the cutting instrument of FIG. 8 is
`introduced. The length of the cutting instrument is such
`that it can extend approximately 0.8 inch beyond the
`end of the cannula when fully inserted. The cutting
`instrument is manually rotated until a window is formed
`in the annulus.
`As shown in FIG. 10, cannula 32 extends through the
`sacro spinalis 56, through the quadratus lumbrum 58,
`and through the psoas major 60 to the exterior of annu-
`lus 64 of the disc. The tubular part 40 of the cutting
`instrument extends into the nucleus 62 of the disc, and
`suction is applied to the nucleus by aspiration through
`the cutting instrument. In many cases excellent results
`are achieved by applying suction through the cutting
`instrument while the cutting instrument is moved back
`and forth by manipulation of grip 44. As the disc is
`decompressed, the herniation 66 recedes, and fragments
`are moved to positions within the disc from which they
`can be withdrawn. Withdrawal of fragments is carried
`out by using the punch forceps of FIG. 9, which can be
`inserted through cannula 32 after the cutting instrument
`is removed. In some cases, fragments can be withdrawn
`by aspiration through the cutting instrument or through
`the cannula.
`
`5
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`

`4,573,448
`
`6
`
`5
`In some cases, it is possible to position the instruments
`so that the cutting instrument enters the bulge of hernia-
`tion, in which case the disc fragments can be withdrawn
`directly.
`The procedure described above, by virtue of the
`postero-lateral approach, avoids the need for bone re-
`moval and the resultant complications. As in the case
`with conventional laminectomy, rehemiation through
`the operatively produced annulus fenestration may oc-
`cur. However, the location of the fenestration produced
`in accordance with this new method is such that reher-
`niation is much less likely to apply pressure to the pa-
`tient’s nerve roots.
`
`I have found that patients treated in accordance with
`this new procedure are generally able to ambulate and
`sit on the day of surgery or one day afterward, and that
`post-operative back pain was minimal and controllable
`by oral medication. Hospitalization time with this new
`procedure is typically two days.
`I claim:
`
`1. A method for decompressing a herniated interver-
`tebral disc in the lumbar region of a human patient
`comprising the steps of:
`inserting a hollow needle with a stylet through the
`skin of the patient’s back at a location spaced from
`the midline of the back and advancing the needle in
`an oblique direction with respect to a line perpen-
`dicular to the patient’s back until it reaches the
`outside of the annulus fibrosis of the herniated disc;
`withdrawing the stylet;
`introducing a guide wire through the needle to the
`disc;
`'
`withdrawing the needle;
`passing a cannulated, blunt-tipped trocar with an
`opening in its tip slightly greater in diameter than
`the diameter of the guide wire, over the guide wire
`until
`the tip reaches the outside of the annulus
`fibrosis of the herniated disc;
`withdrawing the guide wire;
`passing a thin-walled cannula which closely fits the
`trocar, over the trocar until the distal end of the
`cannula reaches outside of said annulus;
`withdrawing the trocar;
`
`introducing through the cannula a cutting instrument
`comprising a hollow circular cylindrical tube hav-
`ing cutting teeth formed in a circle on its distal end;
`with the cannula still in place, forming a window in
`the herniated disc by rotary manipulation of the
`cutting instrument; and
`with the cannula still in place, evacuating fragments
`of the herniated disc through the cannula.
`2. a method according to claim 1 in which the oblique
`direction in which the needle is advanced is at an angle
`of approximately 35 degrees with respect to the perpen-
`dicular line of the patient.
`3. A method according to claim 1 in which anesthetic
`is introduced through the trocar as the trocar is passed
`over the guide wire toward the herniated disc.
`4. A method according to claim 1 in which the inter-
`nal diameter of the thin-walled cannula is at least ap—
`proximately 0.2 inch.
`5. A method according to claim 1 in which the step of
`withdrawing the trocar is carried out while holding the
`cannula firmly against the outside of the annulus fibrosis
`of the herniated disc.
`
`6. A method according to claim 1 in which the cut-
`ting instrument is withdrawn from the cannula, with the
`cannula still in place, and in which evacuation of frag-
`ments is carried out using a punch forceps extending
`through the cannula.
`7. A method according to claim 1 in which the evacu-
`ation of fragments is carried out by aspiration through
`the cannula.
`
`8. A method according to claim 1 in which the evacu-
`ation of fragments is carried out by aspiration through
`the cutting instrument.
`9. A method according to claim 1 in which the evacu-
`ation of fragments is carried out by aspiration through
`the cutting instrument while the distal end of the cutting
`instrument is moved back and forth within the nucleus
`of the herniated disc.
`
`10. A method according to claim 1 in which the evac-
`uation of fragments is carried out by a punch forceps
`extending through the cannula following the applica-
`tion of suction to the nucleus through the cutting instru-
`ment.
`
`11. A method according to claim 10 in which the
`distal end of the cutting instrument is moved back and
`forth within the nucleus of the herniated disc while
`suction is applied.
`it
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`PATENTNO.
`
`:
`
`4,573,448
`
`DATED
`
`: March 4, 1986
`
`INVENTOR(S)
`
`: Parviz Win
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Kindly amend the face of the patent document by inserting the following
`
`—- OIHER REFERENCES CI'IED ”Percutaneous Lateral Discectomy of the Lumbar
`
`Spine", Parviz Kambin, MD. and Harris Gellman, M.D., April, 1983. --
`
`
`
`Signed and Sealed this
`
`Sixth Day of November, 1990
`
`HARRY F. MANBECK, JR.
`
`Attesting Ofl‘icer
`
`Commissioner of Parents and Trademarks
`
`
`
`7
`
`