Abstract (deutsch)
The narrowest point of the entire human airway is at the level of the caudal edge of the triangular cartilage corresponding to the inner nasal valve. The resistance to breathing is largely caused by this narrow point. During inspiration, the Venturi effect on the nasal valve causes the side walls of the nose to be sucked in. Minor constrictions of the nasal valve and instability of the soft tissue of the side walls of the nose cause the nose to collapse. Previous techniques have not been able to achieve safe and permanent stabilization of the nasal valve without additional negative side effects. For over 3 ½ years we have been using a 0.5 mm thick titanium implant to stabilize the soft tissue of the nose. With an open rhinoplasty, the Breathe implant is sewn onto the triangular cartilage with non-absorbable suture material. The permanent spreading of the nasal valve expands the endonasal air space in the area of the critical narrow point. In 53 patients in the pilot study, no infection, exposure or extrusion of an implant occurred. The titanium implant Breathe-Implant is the first stable implant to stabilize the nasal valve. The clinical results to date have been excellent.
Abstract (english)
Objective: To develop a titanium nasal implant that stabilizes and spreads the soft tissue of the nose. The spreading action of Breathe-Implant acts similar to the external spreading strips. The nasal valve should be kept open permanently even in forced inspiration.
Study design and setting: After development of a unique titanium implant for the cartilaginous dorsum of the nose Breathe-Implant has been awarded the European CE-mark and first implantation was in October 2003. The titanium implant is sutured onto the upper lateral cartilage in an open rhinoplasty technique. Currently FDA approval is pending.
Results: In our Pilot Study of 53 patients over three years and in an independent study at the University Clinic of Halle Germany with no infection, exposure, nor extrusion occurred. Cosmetic results are good to excellent. All patients improved significantly in their nasal breathing.
Conclusion and significance: This new nasal implant spreads and stabilizes the nasal valve area. With long-term results of 3 ½ years Breathe-Implant has stood the test of time.
Introduction
The narrowest point of the entire human airway is at the level of the inner nasal valve. The caudal edge of the triangular cartilage forms this inner nasal valve. The resistance to breathing is largely caused by this narrowing. During inspiration, the Venturi effect on the nasal valve causes the side walls of the nose to be sucked in, narrowing the angle. Minor narrowing of the nasal valve and instability of the soft tissues of the side walls of the nose cause the nose to collapse.[1]. The natural angle of the triangular cartilage to the septum is about 15 degrees.
The air jet hits this edge of the nasal valve directly from below the nostril. This explains why patients still experience difficulty breathing through their nose even after perfect septoplasty and conchotomy if the nasal valve narrows too much during inspiration. The Cottle test diagnoses soft tissue instability.
In addition to septal deviation and turbinate hypertrophy, the collapsing nasal valve is the most common and least recognized cause. One reason for the lack of attention to date is that the problem can only be treated insufficiently. The technique of cartilaginous spreader grafts [2], [3], [4], [5] to widen the distance from the septum to the triangular cartilage often does not lead to the desired result. Endoscopic placement does not improve the result either [6]. Sewing on a butterfly graft [7], [8] or other cartilaginous parts [9], [10] can lead to cosmetically unsatisfactory results due to the considerable thickness of the graft. Another soft titanium implant can be pushed into subcutaneous pockets through a median incision on the bridge of the nose [11]. When blowing your nose, the implant is permanently compressed, which closes the nose instead of expanding it. Polyethylene implants have also been suggested [12], [13]. Various previous techniques have not been able to achieve safe and permanent stabilization of the nasal valve without additional negative side effects [14], [15], [16], [17].
Diagnosis
To diagnose nasal valve insufficiency, the nasal endoscope should be held in the vestibule without touching the side wall. During nasal inspiration, suction can be seen in the upper third. Examination with the nasal speculum prevents this diagnosis because it pushes the triangular cartilage to the side and artificially stabilizes it. A positive Cottle test confirms the diagnosis by pulling the facial and nasal soft tissues sideways and stabilizing the valve. This makes nasal breathing easier in patients with nasal valve insufficiency.
The trial with adhesive nasal dilator plasters (Breathe-Right) can convince and motivate patients to receive definitive stabilization with Breathe-Implant. The often atrophic skin of older patients does not tolerate daily application well.
Indications for Breathe-Implant
- Short, small noses with small inner diameter
- High, narrow noses with a tendency to collapse
- Noses of old people with sagging nasal walls
- sportsman
The aim of the titanium implant Breathe-Implant is to keep the nasal valve open even during forced inspiration.
Tips & Tricks
After initial experiments with curved 1.5 mm titanium osteosynthesis plates, a very fine but very stable, anatomically shaped titanium plate of 0.5 mm thickness was developed (Fig. 1). For more than 4 years (October 2003) we have been using Breathe-Implant to stabilize the nasal soft tissue.
The implantation of Breathe-Implant using the open rhinoplasty technique is no problem for the experienced rhinosurgeon. The triangular cartilage should be exposed in its entirety. Gentle preparation with swabs is a good way to do this. We use elastic straps to hold the alar cartilage caudally. Any scroll of the triangular cartilage and the alar cartilage that may be present should only be excised in the area of the alar cartilage in order to preserve the front edge of the triangular cartilage. The front edge of the implant must then be 1 to 2 mm behind the front edge of the triangular cartilage in order to protect the implant from endonasal exposure. (Fig. 2).
The choice of implant width is made intraoperatively using five different dummies placed on the triangular cartilage, thus determining the width of the middle section. Four sizes are available: S, M, L and XL (Fig. 3). To fix the titanium implant we use the non-absorbable suture material Prolen 6-0 with a P3 needle (Fig. 4).
If no additional endonasal procedure is performed, open rhinoplasty with Breathe Implant can also be performed under local anesthesia. After a little practice, the procedure can be performed in less than an hour.
Results & Discussion
This is the first publication worldwide about Breathe-Implant. Since the first implantation in October 2003, we wanted to wait for a safe observation period of over 4 years. The first implantation took place after receiving the CE mark. In a pilot study, we examined the first group of 53 patients. All patients are successfully wearing their Breathe-Implant. There was no rejection reaction. No implant is exposed at any point, either endonasally or externally. There was also no infection or impaired wound healing. In the meantime, over 100 patients have been successfully implanted at several clinics in Germany and Switzerland.
Thanks to the position of the Breathe-Implant between the two cartilage structures of the triangular cartilage and the alar cartilage, the implant is well protected. Because the implant does not protrude beyond the front edge of the triangular cartilage, it cannot be exposed even when picking your nose with your finger.
If the implant width is chosen correctly, the nose will not be aesthetically altered. However, if desired, a nose that is too narrow can be widened to a normal width (Fig. 5).
All patients report significant relief and improvement of nasal breathing through endonasal dilation (Fig. 6). Thanks to the stabilized nasal breathing, athletes can now also rely on their nose even during the strongest inhalation.
The implant is not noticeable to the patient in its position. The implant can only be felt deep in the soft tissue when the nasal soft tissue is compressed by the fingers when blowing the nose. No patient has expressed any negative opinions about this.
The goals of this new titanium implant are:
- expansion of the too narrow nasal valve
- Stabilization of the nasal valve during inspiration and thus prevention of collapse due to the Venturi effect
- No change in the shape of the nose
The titanium implant Breathe-Implant is the first stable implant to stabilize the nasal valve. The clinical results to date have been excellent.
Author's statement
The author would like to thank Mr. Uwe Steinhardt, development engineer at Heinz Kurz GmbH, Dusslingen, Germany, for his excellent cooperation in the development of Breathe-Implant.
Illustrations