PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 22 noS. 1 & 2 January –June; July – december 2007 SURGICAL INNOVATIONS AND INSTRUMENTATION PhiliPPine Journal of otolaryngology-head and neck Surgery 27 ABSTRACT Objective: To describe a novel harpoon design for a low cost, self retaining tympanostomy tube with applicator used in a 38-year-old female for otitis media with effusion. Methods: a. Study design: Instrumental Innovation/Case Report b. Setting: Tertiary Hospital in Metro Manila Results: The tympanostomy tube was inserted under endoscopic guidance within 10 seconds, remained in place for two months with relief of symptoms, and spontaneously extruded by the seventh month of follow-up. Conclusion: The harpoon-designed tube with applicator provided ease of insertion and good anchorage in the tympanic membrane. Maximizing the use of a stylet-needle as both perforator and applicator simplified the tympanostomy and ventilating tube insertion procedures into a single maneuver. Key words: middle ear ventilation, tympanostomy tube insertion, grommet insertion, instrumentation The pAThOgeneSiS and natural history of middle ear disease were most strikingly altered with the reintroduction of practical, safe and effective middle ear pressure equalization tube (PET) by Armstrong in 19541. Otitis Media with effusion (OME) is a common sequel of acute otitis media (AOM). Otalgia, aural fullness and hearing loss are the common complaints. Oral antibiotics remain the treatment of choice for acute otitis media. Over 90% of patients are clinically cured two weeks after the onset of therapy2,3. Acute symptomatic failures are observed, in part due to antibiotic resistance, increasing tympanocentesis recommendations for culture purposes in AOM4. For persistent effusion, the most commonly used treatment option for most patients is tube insertion5. Myringotomy without tube insertion is not commonly recommended because of rapid closure of the tympanic membrane fenestration4. Myringotomy with placement of ventilating tubes has become the standard of care for children with OME that has lasted more than three to four months and is unresponsive to conservative treatment6. Tympanostomy tubes are highly effective for children and adults with middle ear effusion, with most remaining free of middle ear disease while the tubes remain patent and functional7. Prolonged middle ear ventilation of approximately 6 to 12 months provided by most first line PETs helps to restore the Eustachian tube- middle ear-mastoid complex to a more normal physiologic state, improving hearing and preventing infection8. Because of prohibitive costs and inavailability of commercial tympanostomy tubes, it is common practice in our institution to fabricate myringotomy tubes from 18-gauge intravenous plastic catheters cut into 5 mm segments and heat-flanged over both ends. We describe a novel low-cost, self retaining harpoon tube with applicator that facilitates both tympanostomy and insertion into, as well as anchorage and retention in, the tympanic membrane. Self-Retaining harpoon Tympanostonomy Tube with Applicator Konrad P. Aguila, MD Department of Otorhinolaryngology-Head & Neck Surgery Jose R. Reyes Memorial Medical Center Correspondence: Konrad P. Aguila, MD Department of Otorhinolaryngology Head & Neck Surgery Jose R. Reyes Memorial Medical Center Rizal Ave., Sta. Cruz, Manila 1003 Philippines Telefax: (632) 743-6921 E-mail: kon_eagle@yahoo.com Reprints will not be available from the author. No funding support was received for this study. The author signed a disclosure that he has no proprietary or financial interest with any organization that may have a direct interest in the subject matter of this manuscript, or in any product cited in this report. Presented at the Surgical Innovation Contest (1st Place) Philippine Society of Otolaryngology Head & Neck Surgery Annual Convention, Westin Philippine Plaza Hotel, Pasay City, December 1, 2005. Philipp J Otolaryngol Head Neck Surg 2007; 22 (1,2): 27-30 c Philippine Society of Otolaryngology – Head and Neck Surgery, Inc. PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 22 noS. 1 & 2 January –June; July – december 2007 SURGICAL INNOVATIONS AND INSTRUMENTATION 28 PhiliPPine Journal of otolaryngology-head and neck Surgery To compute for the total cost in the production of one set of the device, the cost of one piece of IV catheter, one piece of tuberculin syringe and ¼ of the total amount in the fabrication of the tube were added giving a sum of Php57.25. procedure: A. Tympanostomy Tube Fabrication A 2 x 1cm. piece of aluminum foil was rolled around the intravenous plastic catheter about 1 mm from its tip to serve as guide, with the stylet needle used as stopper. The rim edge was smoothened with a sharp blade (Figures 1 & 2). The rolled aluminum foil was slid further away to 2 mm from the catheter tip, and two slits 180o apart were cut into both sides of the catheter, each starting from the edge of the guide aluminum foil and extending 1 mm towards the tip. The stylet prevented each cut from extending to the other side of the catheter (Figure 3). The flaps made on each proximal side of the catheter were then elevated and folded, and the distal side of the catheter was cut 5-7 mm from the tip, and the rim was flared over an open flame. Alternately, two tongue depressors could be used as template, cutting a groove in both tongue depressors for the catheter to fit between them when placed together, exposing 2-3 mm of the tip to be flared. It could then be secured with a clip and heated over an open flame (Figure 4). The procedure was repeated to fashion four tubes (Figure 5). B. Tympanostomy Tube Applicator Set: A second 18 Gauge intravenous plastic catheter was marked alongside the fabricated tympanostomy tube and cut at a point from the tip corresponding to the tube length. The stylet was reinserted into the intravenous catheter, and the cut portion of the intravenous catheter and fabricated tympanostomy tube were reinserted into the stylet (Figure 6). After trimming excess portions of the intravenous catheter that could interfere with insertion (Figure 7), the assembly was attached to a tuberculin syringe to serve as handle (Figure 8) and soaked for 30 minutes in Glutharaldehide 2% (Glutharex™ 3M, Columbia) for sterilization then rinsed with sterile distilled H20. Note that the tube’s end was modified into a harpoon-like structure which was incorporated into the tip of an intravenous catheter system to become a self-retaining tympanostomy tube with applicator. Using the attached tuberculin syringe as a handle, the metal stylet of the intravenous catheter was designed to puncture the tympanic membrane and facilitate tube insertion in one motion. The arrow- FigURe 1: Aluminum foil used a guide FigURe 2: Smoothened edge FigURe 3: Make a slit 180o apart FigURe 4: Tongue depressors as template in burning one end to make a flare end FigURe 5: Finished product of a tympanostonomy tube FigURe 6: Reinsert the new IV catheter and the fabricated tympanostonomy tube into the stylet Table 1. Tympanostomy Tubes Manufactured by Medtronic Xomed, USA locally distributed by FAMED Company Type Price per box(5pcs) Price per piece Sheehy Collar Button Php 5,610 Php 1,122 Shepard Grommet Php 3,300 Php 660 Pediatric Php 3,630 Php 726 Goode T-tube Php 6,930 Php 1,386 PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 22 noS. 1 & 2 January –June; July – december 2007 SURGICAL INNOVATIONS AND INSTRUMENTATION PhiliPPine Journal of otolaryngology-head and neck Surgery 29 head design automatically leaves the tube in place after applicator withdrawal. ReSULTS With institutional review board approval and informed consent, the device was used on a 38-year-old female with eight months’ aural fullness and hearing loss unrelieved by medications diagnosed to have otitis media with effusion. Tympanostomy tube insertion was performed under topical anesthesia using Lidocaine 25 mg, Prilocaine 25 mg, 5% cream (EMLA™ AstraZeneca) applied for 15 minutes. A 2.7 mm Oo rigid scope (model 8670.31 Wolf USA) and Telecam video system (SL NTSC, Karl Storz, Germany) were used to document the procedure (Figures 9&10). The tube was applied within 10 seconds, obtaining clear serous fluid with relief of symptoms. The tube was in place at one week and two months follow-up (Figure 11), and spontaneously extruded by the seventh month follow-up. DiSCUSSiOn There are many different types of tympanostomy tubes currently in use. They differ in size, shape, materials, coatings and theoretical advantages for the surgeon or patient. Commercially available tympanostomy tubes are expensive and burdensome to our financially constrained patients. The cost of a single tympanostomy tube obtained from local suppliers ranges from Php 500 to Php 1,500 depending on the type & brand (Table 1). The fabrication of this device will only cost Php 57.25. In our local hospital setting, tympanostomy tubes were improvised using a gauge 18 intravenous catheter. One IV catheter was cut and reduced into four 10 mm long tubes with both ends of the tubes heated to make patent flared rims. The technique of myringotomy and ventilating tube insertion was the same as the standard procedure. The new self retaining tympanostomy tube with applicator is designed to aid the surgeon in performing myringotomy and ventilating tube insertion in a single maneuver. This instrument was inspired by the principle of inserting a catheter intravenously with the aid of a stylet-needle that is subsequently withdrawn to leave the catheter in place. To keep the new tympanostomy tube in place, it is designed like a harpoon which facilitates smooth insertion but is kept automatically in place upon slight retraction with the aid of the hooks located on each side of the tube (Figures 12-14). The stylet-needle functions as perforator and applicator eliminating the need for a tympanostomy blade further reducing the expense for the procedure. The attached syringe not only serves as a convenient handle but is also very useful in aspirating discharge for specimen collection, hence, making myringotomy and tympanostomy tube insertion less time consuming. The device can be used under local or general anesthesia. The tympanic membrane can be visualized with or without the use of an aural speculum, under otomicroscopic magnification, or video- endoscopic guidance. During the procedure, care should be given not to injure the external auditory canal or any other part of the tympanic membrane. The plastic IV catheter may be slid gently forward using the middle finger until the posterior flange end touches the tympanic FigURe 7: Remove parts that may interfere with VT insertion FigURe 8: Attach the assembly to a tuberculin syringe to serve as handle FigURe 9: Insertion of the tube FigURe 10: Tympanostomy tube in place FigURe 11: 2 months follow-up PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 22 noS. 1 & 2 January –June; July – december 2007 SURGICAL INNOVATIONS AND INSTRUMENTATION 30 PhiliPPine Journal of otolaryngology-head and neck Surgery membrane. Special attention should be given to introduction of the device, inserting the tube until the hooks have penetrated the tympanic membrane and gently retracted until the hooks are secured. Avoid pushing the device way beyond the tympanic membrane into the middle ear cavity. Such an occurrence is a remote possibility owing to the relatively smaller puncture produced by the needle compared to the larger posterior flange of the device which functions as a stopper, but could potentially happen if extreme force is applied. The device should self-extrude, but removal may be performed with fine serrated end ear microforceps. This modification in the fabrication of a tympanostomy tube from a gauge 18 IV catheter made tube application fast and easy. The harpoon design facilitated tube insertion into the tympanic membrane and helped keep the tube in place. Aside from the low cost of material in the production, maximizing the use of stylet-needle, functioning as perforator and applicator eliminated the need for a tympanostomy blade, which simplified the tympanostomy and ventilating tube insertion procedures. Although the device was used effectively and safely in one patient, evidence is lacking with regards extrusion rate, risks and complications and further studies of its use on a larger sample size with longer duration of follow-up and comparison with commercially available tympanostomy tubes are suggested. ACKnOWLeDgeMenT: I would like to express my sincere gratitude to Jose A. Malanyaon, Jr., MD for his unselfish contribution in supervising the creation of this paper, and to the residents of the Department of ORL-HNS, JRRMMC for their untiring assistance in the documentation of the tympanostomy tube fabrication and performance of surgical procedure. ReFeRenCeS: 1. Armstrong BW. A new treatment for chronic secretory otitis media. Arch Otolaryngol 1954; 59:653-654. 2. McCracken GH, Jr: Treatment of acute otitis media in an era of increasing microbial resistance. Pediatr Infect Dis J 1998; 17:1084-1089; discussion 580. 3. Rosenfeld RM, Verterees JE, Carr J, et al.: Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J pediatr 1994; 124:355-356. 4. Pransky SM: Surgical strategies for otitis media. J Otolaryngol 1998; 27(Suppl 2):37-42. 5. Rosenfeld RM, Post JC; Meta-analysis of antibiotics for the treatment of otitis media with effusion. Otolaryngol Head Neck Surg 1992; 106:378-386. 6. Bower C, Waner,M. Laser Assisted myringotomy. Current Opinion in Otolaryngol Head & Neck Surg 1999 Dec; 7(6) : 335. 7. Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza, RJ. Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Arch Otolaryngol Head Neck Surg 1989; 115:1217-1224. 8. Brodsky L, Brookjauser P, Chait D, Reilly J, Duetsch E, Cook S, et al. Office-based insertion of pressure equalization tubes: The role of laser-assisted tympanic membrane fenestration. Laryngoscope, 1999 Dec 109(12) 2009-2014. 9. Lindstorm R, Reuben, B, Jacobson K, Flanary V, Kerschner J. Long-Term Results of Armstrong Beveled Grommet Tympanostomy Tubes in Children. Laryngoscope 2004 Mar; 114(3): 490-494. FigURe 12: Insertion of the device into the external auditory canal FigURe 13: Insertion of the device through the tympanic membrane FigURe 14: Withdrawal of the device leaving the tube in place MATERIALS AND METHODS Material Manufacturer Amount Cost (PhP) INTRAVENOUS INTROCAN-W, 2 36.50 each CATHETER 18 B.BRAUN Laboratories, GAUGE, 1.3 x 45 mm Brazil TUBERCULIN (1ml) Becton, Dickinson & Co. 1 6.50 each SYRINGE Singapore BLADE No. 11 Feather, Safety Razor Co., LTD, Japan 1 10.00 each CANDLE LIWANAG, Sevilla Candle Factory, Malabon City, Philippines 1 7.00 each TONGUE DEPRESSOR Union Wooden Tongue 2 0.50 each Depressor Manufacturing Co. Philippines ALUMINUM FOIL Paramount Foil Manufacturing, U.S.A 2cm x 1cm negligible