T HE L ARY NGOSCOPE 88 :19 78
`
`GELFOAM PASTE INJECTION FOR VOCAL CORD PARALYSIS:
`TEMPORARY REHABILITATION OF
`GLOTTIC INCOMPETENCE.*t
`
`VICTOR L. SCHRAMM, JR., M.D.,
`MARK MAY, M.D.,
`and
`ALFRED S. LAVORATO, Ph.D.,
`Pittsburgh, Pa.
`
`ABSTRACT.
`
`Vocal cord paralysis frequently results in open glottic incompetence with aspiration, an
`ineffective cough, and poor voice production. Glottic competence can be restored tempo(cid:173)
`rarily by injecting the true vocal cord with Gelfoam paste. This clinical use of Gelfoam for
`temporary rehabilitation is indicated in: 1) situations in which paralysis may be temporary,
`2) patients for whom an open operative procedure must be delayed, and 3) circumstances
`in which it is desirable to determine the effect of vocal cord injection prior to placement of
`nonabsorbable material. The injection of Gelfoam paste results in minimal tissue reaction.
`Absorption is gradual over a period of six to ten weeks, allowing time for some glottic
`compensation. The injection may be repeated without adverse effects until the paralysis
`resolves or intervention of a permanent nature is indicated.
`
`0
`
`Disturbances of the glottic sphincter which cause open incompetence of
`the glottis may produce major changes in swallowing, coughing, and pho(cid:173)
`nation. Incomplete apposition of the true vocal cords in these situations
`may be corrected temporarily by the injection of Gelfoam®:j: paste. The
`Gelfoam® paste injection technique, its clinical usefulness, and the histo(cid:173)
`logic r esults of injection f orm the basis of this presentation.
`
`REVIEW OF LITERATURE.
`
`Laryngeal disability resulting from incomplete glottic closure may result
`from laryngeal paralysis or from congenital, surgical, or t raumatic vocal
`cord volume deficiency. Injection of the vocal cord has been used for all
`of these situations. Brtinings,t in 1911, injected par affin into vocal cords
`and was the first to report the results of such a procedure. Ar nold 2
`4 in(cid:173)
`vestigated suitable substances for injection, including car tilage, bovine
`bone dust, tantalum powder, and Teflon®§ suspended in glycerine. He
`found that Teflon® is the most suitable material in that it is well-toler ated,
`is not absorbed and is easily injected through the long needle of the Br tin(cid:173)
`ings syringe. 5 The efficacy of Teflon vocal cord injection was established
`by Lewy in his review of the experiences (including his own) of 38 in(cid:173)
`vestigat ors.6
`
`-
`
`*Presented a t the M eeting of t h e E ast ern S ection of the American L a r y ngol og ical, Rhinological
`a n d Ot ologica l Societ y, I n c., P ittsburg h, P a ., J a n uary 7, 1978.
`t From the D ep a rtm ent of Otola r y n g ology, Univer s ity o f P it tsburgh S ch ool of Medicine, E ye a nd
`E a r H ospital, Pittsbu rgh, P a .
`:):T h e U pjohn Compa n y , K a lama zoo, Mich .
`§Codma n a nd Shu r tleff, In c. , R a ndolph, M ass.
`S en d R eprin t R equ es t s t o V ict or L . Schra mm, Jr., M .D ., D ept. of Otola r y n g ology, E ye a n d Ear
`Hospit a l, Pittsburgh, P a. 1 5213 .
`1268
`
`ETHICON EXHIBIT 1007
`
`

`

`SCHRAMM, ET AL.: GELFOAM INJECTION.
`
`1269
`
`Fig. 1. L eft: Gelfoam p aste rolled a nd placed in 5 cc syringe. Right : Paste injected into Arnold(cid:173)
`Brlinings syringe reservoir.
`
`Incomplete glottic closure is the primary indication for Teflon injection.
`Complications of Teflon injection to date have primarily been related to
`mechanical misplacement of the material or over-injection and occur in
`approximately 10 % of cases. Contraindications for Teflon injection include
`paralysis of less than six months duration, lack of attempted rehabilitation
`through voice therapy, and the possibility that the vocal disability is not
`entirely due to inadequate glottic closure. 5
`Three types of materials have been described for temporary vocal cord
`injection. Lewy7 used glycerine injected with a three-ring syringe via
`indirect laryngoscopy. Arnold 2 used liauid gelatin. and Rubin8 reported on
`the use of sesame oil. Because all of these materials have low viscosities,
`the Brlinings gun-type syringe cannot be used to inject them. More im(cid:173)
`portantly, the duration of their effectiveness is less than 1 week and
`usually only 2 or 3 days.
`Gelfoam® was developed as a hemostatic material. It is used widely in
`otologic surgery as a foam or film (the latter is marketed as Gelfilm). The
`foam, when filled with blood, may act as a scaffold for fibrous tissue
`ingrowth9 while Gelfilm10 may provoke a temporary round cell infiltrate
`at the tissue interface but is not permeated by blood, and leaves only a
`thin fibrous scar after absorption. Gelfoam powder is used as a dressing
`material for open wounds and as a hemostatic material for bone bleeding.
`Tissue tolerance has been excellent for all forms of Gelfoam. When Gel(cid:173)
`foam is placed in muscle, it remains for 2 to 5 weeks. 11 The more dense
`Gelfilm remains in the middle ear about 6 weeks. Gelfilm dural or ocular
`implants are gradually absorbed over 8 to 12 weeks. 12 The rate of absorp(cid:173)
`tion depends upon the density of the implanted material and the metabolic
`activity of the receptor tissue.
`
`MATERIALS AND METHODS.
`Sterile Gelfoam powder and physiologic saline are mixed immediately prior to vocal cord in(cid:173)
`jection. One gram of Gelfoam powder is placed in a dish and 4.0 cc of saline is added slowly
`while mixing constantly. The viscosity of the mixture may be varied somewhat, but additional
`saline decreases the duration of Gelfoam retention in the vocal cord. The resulting 5 cc of thick
`paste is placed into the open barrel of a 5 cc syringe and then injected into the Arnold-Briinings
`injection system (Fig. 1). The viscosity of the Gelfoam paste is nearly the same as that of Teflon
`paste, and since the material is cohesive when iniected through a needle, the Teflon injection
`technique with the Amold-Briinings system may be used (Figs. 2 and 3). It is recommended
`that the voice be rested completely for 24 hours following the injection to minimize postoperative
`edema and possible Gelfoam exb"Usion.
`We have injected Gelfoam paste into the b"Ue vocal cords of 25· patients. Vocal cord paralysis
`had followed craniotomy, thyroidectomy, neck or thoracic surgery in 17 patients, and was of
`unknown etiology in 7 patients. One patient was injected to compensate for aspiration following
`supraglottic laryngectomy.
`
`INDICATIONS AND CONTRAINDICATIONS.
`Indications for Gelfoam paste injection complement the indications for
`
`

`

`1270
`
`SCHRAMM, ET AL.: GELFOAM INJECTION.
`
`Fig. 2. Cohesive Gelfoam paste extruded through 18 ga. s ide delivery depth-control needle.
`
`Fig. 3. Gelfoam paste injection of fresh cadaver hemilarynx. Vocal process transected vertical(cid:173)
`ly following injection of Gelfoam (arrow) with s ide delivery needle. Dense Gelfoam paste ,re(cid:173)
`m a ins well localized.
`
`permanent Teflon injection. Any laryngeal abnormality involving open
`glottic incompetence with excessive air escape, poor voice, inability to in(cid:173)
`crease subglottic pressure with coughing, or a chronically open posterior
`commissure with aspiration may benefit from Gelfoam injection. Gelfoam
`should be used in cases of glottic incompetence which are thought to be
`temporary and as a diagnostic test if doubt exists as to the efficacy of
`permanent injection. It may be used at any time following the onset of
`vocal cord paralysis to decrease aspiration or improve voice, and is partic(cid:173)
`ularly useful in association with voice therapy to improve the assessment
`of probable results of a more permanent procedure.
`The only contraindication to vocal cord injection with a temporary ma(cid:173)
`terial remains the possibility of bilateral vocal cord paralysis; a decrease
`in glottic airway without a mobile vocal cord to compensate will not be
`tolerated. A relative contraindication to injection of a temporary sub(cid:173)
`stance exists when the vocal paralysis is known to be permanent and
`immediate permanent rehabilitation is desired.
`
`

`

`SCHRAMM, ET AL. : GELFOAM INJECTION.
`
`1271
`
`RESULTS.
`
`In patients injected with Gelfoam paste because of aspiration, return
`of ability to cough effectively and to swallow without aspiration was
`immediate. In eight patients who had not had antecedent tracheostomy but
`who were injected for aspiration, this ability persisted because they were
`able to learn to compensate during the time when the Gelfoam was. gradu(cid:173)
`ally absorbed from the vocal cord. Tracheostomy for respiratory support
`and tracheal suction had been done in seven patients prior to vocal cord
`injection; three of these patients had multiple unilateral cranial nerve
`defects involving combinations of cranial nerves V through XII. The loss
`of pharyngeal and laryngeal sensation, along with cord paralysis, was the
`most difficult rehabilitation problem in these patients, but with instructions
`regarding the method of swallowing with a closed glottis all but one patient
`were extubated. Four of the tracheostomized patients had return of cord
`mobility, and compensation techniques learned during the slow absorption
`of Gelfoam allowed two others to function adequately and to avoid aspira(cid:173)
`tion even with a permanently lateral cord position. The patient with aspi(cid:173)
`ration following supraglottic laryngectomy ultimately required completion
`of the laryngectomy.
`
`Voice improvement was good to excellent in all patients following Gel(cid:173)
`foam injection. Because of the relatively long period of cord stability fol(cid:173)
`lowing Gelfoam injection, the patients were able to practice and to improve
`the quality of their voice with or without speech therapy. The vocal cord
`characteristics following Gelfoam injection were clinically identical to
`those heard following Teflon injection.
`
`The vocal cord reaction to Gelfoam injection was innocuous in all in(cid:173)
`stances. Local mild mucosal edema at the injection sites resolved in 2 or
`3 days, and no further reactions developed. After mucosal edema had
`subsided, the vocal cord appeared to be normal except for the increase
`in its bulk and its near-midline position, both caused by the Gelfoam in(cid:173)
`jection. During the first 3 or 4 weeks following injection, there was little
`change in the appearance of the vocal cords, but after one month a gradual
`decrease in cord bulk then occurred over the next 4 to 6 weeks. By 10 weeks
`after the injection the vocal cords had returned to their appearances be(cid:173)
`fore the injection. Two patients had second Gelfoam injections prior to
`Teflon injections. Their reactions to the second Gelfoam injections were
`identical to those observed for the first injections.
`
`Histologic results of examination of a vocal cord removed at completion
`laryngectomy 8 weeks following Gelfoam paste injection are seen in Figure
`4. No inflammatory reaction or fibrosis is seen within the Gelfoam mass.
`A thin fibrous capsule is present around the Gelfoam and there is minimal
`inflammatory reaction in adjacent vocal cord muscle.
`
`No untoward result occurred from Gelfoam injection, although the Gel(cid:173)
`foam paste was extruded 2 weeks after its injection in one instance. This
`was due to superficial injection with a standard injection needle, a prob(cid:173)
`lem that has subsequently been overcome with the development of a -side
`delivery depth-control needle system. One patient was injected 6 days fol(cid:173)
`lowing mitral valve replacement and 2 days following discontinuation of
`Coumadin anticoagulation therapy. She developed a hypopharyngeal hema(cid:173)
`toma from glossopharyngeal and superior laryngeal nerve blocks but had
`no vocal cord ecchymosis. The hemostatic property of Gelfoam and the
`local tissue pressure resulting from the injection no doubt were beneficial
`
`

`

`1272
`
`SCHRAMM, ET AL.: GELFOAM INJECTION.
`
`Fig. 4. H and E section of Gelfoam paste in vocal cord 8 weeks following inj ection. Left: G -
`Gelfoam. F - Thin fibrous capsule. M - Vocal cord muscle (original magnification 24X) . Right:
`G - Gelfoam paste with sparse round cell infiltrate. F - Gelfoam-muscle interface with no in(cid:173)
`flammatory reaction. M - Normal muscle ( original magnification 48X).
`
`in this situation. A trial injection was done for one patient who had an
`idiopathic left vocal cord paralysis and a mild right paresis with poor
`voice quality and poor cough. He had marked improvement in his voice
`and cough but felt restricted during active exercise or participation in
`sports. Injection of a permanent material was not done in this case.
`
`SUMMARY.
`The advantages of Gelfoam for temporary injection make it a useful
`addition to compensatory therapy for vocal cord paralysis. Although it is
`a temporary treatment, the duration of the effects of Gelfoam injection
`is 8 to 10 weeks. The effective duration may be decreased, to an extent, by
`increasing the amount of saline used to constitute the paste or decreasing
`the amount of material injected. During the several weeks when the in(cid:173)
`jected volume is relatively constant, speech and swallowing may be prac(cid:173)
`ticed. The slow resorption of the injected material allows for gradual
`compensation in these functions. The injected material has the same con(cid:173)
`sistency as Teflon, which permits use of the same techniques and equip(cid:173)
`ment for injection of both materials. The lack of tissue reaction to Gelfoam
`paste is impressive and clinically is less than for Teflon paste.
`No disadvantages of Gelfoam injection have been noted. The use of
`Gelfoam paste as a temporary remedy for vocal cord incompetence has
`been found to be effective and safe in 25 patients.
`ACKNOWLEDGMENT.
`The authors thank Raimund G. Rueger, M.D. and David R. Rogerson,
`M.D. for allowing the histologic evaluation of the laryngeal specimen.
`
`

`

`SCHRAMM, ET AL.: GELFOAM INJECTION.
`
`1273
`
`BIBLIOGRAPHY.
`
`1. BRUNINGS, W.: Uber eine neue behandlungsmethode der recurrenslahmung. Verh. Deutche
`Laryngol., 18:151, 1911.
`.
`2. ARNOLD, G. E.: Vocal Rehabilitation of Paralytic Dysphonia. IX. Technique of Intra(cid:173)
`chordal Injection. Arch. Otolaryngol., 76:358-368, 1962 ..
`3. ARNoLD, G. E.: Vocal Rehabilitation of Paralytic Dysphonia. X. Functional Results of In(cid:173)
`trachordal Injection. Arch. Otolaryngol., 78:179-186, 1963.
`4. ARNOLD, G. E.: Alleviation of Aphonia or Dysphonia Through lntrachordal Injection of
`Teflon Paste. Ann. Otol. Rhinal. Laryngol., 72:384-395, 1963.
`5. KIRCHNER, F. R., ToLEDO, P. S. and SvoBODA, D. J.: Studies of the Larynx After Teflon In(cid:173)
`jection. Arch. Otolaryngol., 83:350-354, 1966.
`6. LEWY, R. B.: Experience with Vocal Cord Injection. Ann. Otol., 85:440-450, 1976.
`7. LEWY, R. B.: Tracheotomy Avoidance: Glycerine Vocal Cord Injection. Arch. Otolaryngol.,
`92:502-504, 1970.
`8. RuBIN, H. J.: Misadventures with Injectable Polytef (Teflon). Arch. Otolaryngol., 101:
`114-116, 1975.
`9. JosEPH, R. B.: The Effect of Absorable Gelatin Sponge Preparations and Other Agents on
`Scar Formation in the Dog's Middle Ear. THE LARYNGOSCOPE, 72:1528-1548, 1962.
`10. HoLZER, F.: The Fate of Gelatin Film in the Middle Ear. Arch. Otolaryngol., 98:319-321,
`1973.
`11. JENKINS, H. P. and CLARKE, J. S.: Gelatin Sponge, a New Hemo~tatic Substance -
`Studies on Absorbability. Arch. Surg., 51:253-261, 1945.
`12. DANIELE, S., ET AL.: Gelatin as an Absorbable Implant in Scleral Buckling Procedures.
`Arch. Ophthalmol., 80:115-119, 1968.
`See Discussion on Page 1278.
`
`CALL FOR PAPERS.
`
`The 36th Annual Meeting of the American Cleft Palate Association, San
`Diego, California, will be held February 25-March 1, 1979.
`The Program Committee is soliciting from members and friends scien(cid:173)
`tific papers, exhibits, motion pictures, videotapes, and poster sessions
`dealing with all aspects of craniofacial malformation. Entries to be con(cid:173)
`sidered for presentation at the annual meeting must be submitted on
`official forms, which can be obtained from the Program Chairman. The
`deadline for submission of abstracts is September 30, 1978. Acceptance
`letters will be mailed November 22, 1978.
`For more information contact: William S. Garrett, Jr., M.D., Program
`Chairman, 3600 Forbes Avenue, Pittsburgh, Pa. 15213.
`
`