NL1039169C2

NL1039169C2 - Peri-implant ultrasound debridement device (pius-dd).

Info

Publication number: NL1039169C2
Application number: NL1039169A
Authority: NL
Inventors: Hoshang Komosi
Original assignee: Kamosi Hoshang
Priority date: 2011-11-15
Filing date: 2011-11-15
Publication date: 2013-05-16
Also published as: WO2013073935A1

Description

Title of invention Peri-Implant Ultrasound Debridement Device (PIUS-DD) 1039169 2

Background

As a result of peri-implantitis caused by pathogenic microflora, the implant surface becomes covered by bio-film. The current treatment modalities advocated in the treatment of peri-implantitis have been reported to exert some beneficial and successful effect. Albeit, up to 5 present none of the implemented therapeutic strategies, using variety of physical and or chemical decontamination techniques and devices have proved to be the most efficacious in the treatment of advanced peri-implantitis with specific morphology, extent and severity.

Surgical therapeutic approaches are undertaken: to eliminate intra-lesion granulation tissues via surgical deregulation; to eradicate interfacial biofilm and residual debris consisting of surgical 10 mechanical and chemical surface debridement; to decontaminate the contaminated exposed interface via surgical surface decontamination techniques; to modify the interface architecture via implantoplasty (to reduce the risk for re-establishments of implant surface biofilm); to eliminate intrabony micro-environmental niche for pathogenic micro-organisms via resection, and to restore the bone defects caused by destructive pathologic process via regenerative 15 techniques and to promote the phenomenon of re-osseointegration via: surface bio-modification, augmentation techniques, and GBR.

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The therapeutic strategies involved in the treatment of biomaterial-centred peri-implantitis should consider the following objectives: 1. Reduction and elimination of the supra-gingival bacterial plaque and establishment of an environment unfavourable to the bacterial adhesion & colonisation 5 2. Reduction and elimination of the sub-gingival anaerobic pathogens 3.. Establishment of a surgical approach designed to maximise the 3-D surface access, and efficacy of applied mechanical devices during the process of deregulation, surface debridement and detoxification of the exposed implant surface 4. Dissolving and disrupting the remaining biofilm or protein pellicle using solvents, local 10 antibiotics or oxidizing solutions which effectively remove the micro-organism 5. Elimination of the existing well-established anaerobic micro-ecosystem and establishment of compatible anatomic tissue architecture by undertaking appropriate surgical procedures e.g. gingivectomy, surgical peri-implant pocket reduction and apically repositioned flap 15 6. Re-establishment of a micro-ecological niche non-compatible to the bacterial re-adhesion & re-colonisation 7. Intra-marrow penetration & bleeding into the defect area is obtained by local osteotomy of the adjacent bone leading to implant surface coverage with fresh blood clot fixed by fibrin organization prior to the regenerative procedure.

20 8. Restoration of the compromised anatomical architecture and physiological function by: application of appropriate biological mechanism of regeneration versus repair, recruiting the appropriate regenerative devices, and attracting osteoprogenitor cells by receptor-specific cytokines and signal molecules 9. Maintenance of status sanita by eliminating the risk / confounding factors involved in the 25 aetiopathogenesis of biomaterial-centred peri-implantitis (Supportive Peri-implant Therapy) 4

Rational for invention of a new device to enhance the effectiveness of debridement/decontamination procedures

The extent and quality of bone regeneration and re-osseointegration at the interface following the treatment of peri-implantitis lesions using the regenerative means has been reported to be 5 inconsistent in various trials and case reports. This could be due to the fact that the currently applied interface debridement /decontamination techniques, perquisite for the resolution of peri-implant lesions are not performed effectively according to appropriate clinical protocols within the specific indication criteria.

The Peri-Implant Ultra-sound debridement device (PIUS-DD) is driven via precise and powerful 10 ultrasound oscillation transmitted by a centrally fixated piezo-electric core engineered on the basis of Piezo-ceramic principles applied in dentistry, using 4 piezo-ceramic discs mounted on a core, covered by a hand piece extended to a connector device holding the PIUS debridement device. The piezo-ceramic phenomenon is generated as a result of proportional alternating expansion and contraction of quartz crystals when being charged by alternating positive and 15 negative electrical current.

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Engineering description:

The amplitude of the lateral movement is mainly determined by the material characteristics, the length of active part of the instrument, which could be adjusted using the laser-marked circle lines.

5 The profile and pattern of movement is determined by oscillation frequency (Hz) adjusted by power setting, the instrument’s technical specifications (i.e. weight, EM), tangential contact pressure, irrigation volume and working confinement within the defect area.

Power setting is adjusted to the instrument classification and indication of use according to the stage of debridement process and surface characteristic of the implant involved.

10 The continuous irrigation is mandatory and is regulated until an acoustic cavitation effect is reached.

PUIS-DD manufacturing description

Power generation: Ultrasound oscillation in range of 20-30kHz.

Instrument holding device: Stainless Steel (Fig.1) 15 PIUS device holder 120°: For the flexible use of PIUS instrument, specially designed for anterior implants.

PIUS device holder 90° : For the flexible use of PIUS instrument, specially designed for posterior implants.

Instrument brush plate: Ni-Ti/SS alloy; H: 8mm; L: 5.23mm; R: 2.5mm (Fig.2, Fig.4, Fig.6) 20 Instrument shaft: Ni-Ti/SS alloy; H: 18mm; R: 0.45mm (Fig.1, Fig.3, Fig.4, Fig.5)

Instrument core: Ni-Ti/SS alloy; H: 2mm; R: 2.5mm -/+ 0.2mm (Fig.2, Fig.3, Fig.4, Fig.5, Fig.6)

Instrument bristles: Nickel -Titanium alloy (Fig.3, Fig.5, Fig.6)

Ni-Ti alloy with 1 EM, t tensile strength (TS), T abrasion resistance, L: 1.5mm 25 The distribution and length of the bristles is designed and arranged in compatibility to the implant systems’ pitch sequence & design (Fig.5)

General instruction for the application of PIUS device

After performing of an atraumatic access flap, the surgical sequence described below should be performed in order to promote effective decontamination of implant surfaces: 30 1. Partial removal of the excessive bone-bound granulation tissue at the defect entrance to create adequate access for the instrumentation procedure OBS: The partial excision of the excessive peri-implant bone-bound granulation tissue at the defect entrance is undertaken in order to promote decontamination of implant surfaces. Albeit, the rational for total removal of the bone-bound granulation tissue is disputable, as during the 35 initial mechanical gross debridement of the infected implant surface, the peri-implant healthy 6 tissues may be contaminated by the disrupted biofilm, or that the detached pathogenic bacteria may be transfused by intra-osseous venous micro-vascular network giving rise to a sub-acute systemic bacteraemia, especially in patients with propensity to endocarditis or in immunocompromised patients.

5 2. Implant surface degranulation 3. Air-abrasive debridement 4. PIUS fine debridement 5. Total removal of the bone-bound granulation tissues and unsupported bone sequesters followed by saline irrigation 10 6. Intra-marrow penetration, bleeding stimulation, fibrin stabilisation 7. Performance of an appropriate regeneration technique.

NB: PIUS debridement device is manufactured for single use only, hence should not be reused due to the risk for organic contamination and cross infection. The damaged device should not be used.

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Claims

1. Metal curette instruments appear to micro-scratch deeply and leave traces in the most implant surface, while the carbon fiber curettes appear to be inefficient debridement procedure. The hair of the PlUS device is designed to thoroughly, but gently debridate the entire implant surface, especially the inner parts of the implant threads, without otherwise being left unaffected by hand or rotating brush that. The tangential brushing action is designed to debridify the organic and inorganic waste into a perimeter pattern, with a soft but optimized polishing effect on the implant surface topography.

2. Compared with the recently introduced rotary instruments, this incipient echo-derived PIUS instrument has been designed and manufactured to optimize peri-implant debridement, disinfection and irrigation, without exerting adverse physical impact on the peri-implant surface texture, or a biological impact on the peri-implant bone and mucosa. Besides, the non-traumatic posterior surface design eliminates the risk for the occurrence of systemic sepsis caused by the spread of dissolved and disrupted biofilm products in the peri-implant healthy hard and soft tissue environment and their vascular delivery during the oscillating movements.

3. In short the PIUS-DD: • Improves the efficiency and effectiveness of the treatment considerably

20. Increases the predictability of the debridement / decontamination procedure • Exercise soft but optimized polishing effect on the implant surfaces • Improves atraumatic access to narrow angular intra-ossal abnormalities with respect to rotating instruments • Optimizes debridement access to and effectiveness within the implant screw Inner 25 spaces • Unlike hand and rotary instruments, where the innermost part of the wires has not been affected yet, the tangential brushing action of PIUS device removes the surface debris in a perimeter pattern

30 Rotary-driven debridement devices Designed to work through rotary action of rotary hand-piece Safety: Inherent risk of traumatizing the peri-implant tissue due to the sharp and hard brush surface of the device toward the healthy tissue, and the rotary action of hair. 1039169 Precision: require more pressure, and increased control and dexterity needed for debridement procedure Effectiveness: Due to the mode of rotary action with lack of cavitation and acoustic streaming effect, and due to the profile of the device, the most intimate becomes biofilm 5 particles are left undisturbed from the implant surface. Ultrasound-driven debridement devices Designed to work via the oscillating effect of piezoelectric technology Safety: Minimal risk for peri-implant tissue trauma due to the smooth surface of the device toward healthy tissue, and non- rotating effect of hairs. Precision: Requires less pressure, which improves manual handling and dexterity. Offers increased precision of maneuvering during the debridement procedure. Effectiveness: Due to the mode of oscillating action, hydrodynamic effect and the profile of the device, the most intimate biofilm particles are disturbed from the implant surface. Bactericidal effect through cavitation and acoustic streaming