Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders

Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat.

Apparatus and methods for dilating and modifying ostia of paranasal sinuses and other intranasal or paranasal structures

Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

Devices, systems and methods for diagnosing and treating sinusitis and other disorders of the ears, nose and/or throat

Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Methods and apparatus for treating disorders of the ear, nose and throat

Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies. Access and occluding devices may be used to facilitate insertion of working devices such asendoscopes, wires, probes, needles, catheters, balloon catheters, dilation catheters, dilators, balloons, tissue cutting or remodeling devices, suction or irrigation devices, imaging devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting or delivering devices and implants, etc.

Devices, systems and methods for treating disorders of the ear, nose and throat

The amount of different clinically available lasers is increasing. The ENT surgeon can therefore use the best laser for the planned operation. As the resources of the hospital do not increase with the laser technology, a decision has to be made whether in addition to the universal CO2-laser other types must be acquired and which type is best. This paper presents the characteristics and typical tissue interactions of several lasers for the area of the soft palate. Typical operative examples are shown, e.g. partial resection of the soft palate in patients with bronchopathy and sleep apnoea syndrome, tonsillectomy, tonsillotomy and adenotomy in adults.

Derzeitiger Stand der Laserchirurgie im Bereich des weichen Gaumens und der angrenzenden Regionen

SummaryProgressive miniaturization of rigid and flexible endoscopes enables the practising otorhinolaryngologist (head and neck surgeon) to visually inspect regions of the upper respiratory tract that could never have been inspected directly before, or had only been accessible for direct view by massive traumatization of the anatomic surroundings. For the otologist, microendoscopy opens up the possibility of using an endoscope to assess the luminal situation of the Eustachian tube, in order to detect morphological obstructions of this normally collapsed connection between the middle ear compartment and the nasopharynx. The first basic laser surgery on polyps and oedematous soft tissues to restore the essential proper ventilation and drainage of the tympanic cavity have been performed and data about this topic are soon to be published. The ‘mother-baby endoscope’ technique allows us to reach into the nasopharynx and paranasal sinuses via the natural orifices, for a direct visual diagnosis of chronic secret...

Miniature endoscopes in otorhinolaryngologic applications

Animal experiments in mature guinea pigs were devised to determine whether and to what extent inner ear damage can be caused by in vivo use of the erbium laser for stapedotomy. The present study examined the laser effect in connection with perforation of the basal convolution of the cochlea and subsequent application in the opened cochlea. Acoustic evoked potentials as compound action potentials (CAP) were recorded for changes in inner ear function. Findings demonstrated that five applications of the erbium:YSGG (yttrium-scandium-gallium-garnet) laser (energy, 85 mJ/pulse; energy density, 36 J/cm2) were needed to create a footplate perforation of 500–600 μm and did not lead to CAP alteration in any animal (n = 20). An increase of the repetition rate from 1 to 5 Hz likewise caused no CAP alteration (n = 17). Application of high total energies in the open cochlea (n = 5) to determine the safety of the laser system for stapedotomy revealed that a 10-fold increase in the total energy required for adequate perforation led to irreversible CAP alterations and no CAP could be recorded at a 15-fold increase in total energy. In contrast, a 5-fold maximum increase in total energy caused no CAP alterations. These results demonstrate the safety of the Er:YSGG laser comparable to that of the CO2 laser for stapedotomy, supporting its utility as an alternative method for surgery.

Experimental studies on the suitability of the erbium laser for stapedotomy in an animal model.

Background and Objective

Apart from the ablation properties at the stapes footplate, the degree of thermic loading in the inner ear is important in determining the suitability of pulsed lasers for stapedotomy. The aim of the study is to compare the thermic effects in the vestibule with different pulsed laser systems.



Study Design/Materials and Methods: Temperature increases and heat exchange processes in the fluid (physiological saline) were examined in a calorically and physiologically approximated cochlea model for applying the laser parameters effective in creating footplate perforations.



Results

With all systems, increases in the energy density, number of pulses, and thus resultant total energy lead to higher temperatures. In the effective energy density range, the highest temperature increases achieved with the requisite number of pulses at a distance of 2 mm behind the perforation are 26°C with the Ho:YAG laser. The lowest temperature maxima are 5.5°C with the Er:YAG and <5°C with the Er:YSGG laser. The excimer laser, investigated at only one energy density, showed maximal temperatures of 10°C.



Conclusion

The Er:YSGG and Er:YAG laser can be applied in laser stapedotomy in a relatively broad energy density range without a risk of inner ear damage by thermic loading. On the other hand, the Ho:YAG laser is not recommended for stapedotomy because of the higher energy density and pulse rate required for sufficient perforation and the resultant higher temperature increases in the perilymph. Though likewise achieving perforations with only slight temperature increases in the fluid of the cochlea model, the excimer laser does not seem appropriate for stapedotomy because of the long period of heat exposure (ca. 60 s) due to the lower ablation rate at the stapes necessitating a longer application time. Lasers Surg. Med. 23:7–17, 1998. © 1998 Wiley-Liss, Inc.

Thermic effects in the "vestibule" during laser stapedotomy with pulsed laser systems.

Stapedotomy is not only one of the most successful interventions in otology but also one of the most dangerous for the inner ear. To reduce the risk of damaging middle and inner ear structures through manipulations with conventional instruments, the CO 2 laser beam is used for perforating the footplate and removing the suprastructures. This non-contact technique aims at precise and controlled management of middle ear structures. Consideration is given to the impact of experimental data on the clinical application of the CO 2 laser in stapes surgery. The discussion covers the advantages and disadvantages with regard to optical and tissue-related properties and points out possible dangers to the inner ear. Our experimental and clinical experience is taken as a basis for examining the surgical technique and the varying demands made on the laser beam in treating the stapedial tendon, crura and footplate. Attention is called to the need for additional instruments. Effective energy parameters for CO 2 laser stapedeotomy are evaluated for different lasers. Application of the CO 2 laser contributes towards optimization of this high-precision intervention and promises to reduce the incidence of inner ear damages in large numbers of cases. This technique appears useful particularly in difficult anatomic situations and, above all, for revisional operations.

CO 2 laser in stapes surgery

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