Osseous--ENT_Product_Details---NOBLE_PHARMA

PREPARED BY:

EON MEDITECH PVT. LTD.

R&D DIVISION

THE HUMAN EAR

INTRODUCTION

The ear is divided, semi-artificially, into three regions:

Figure 1: THE HUMAN EAR

The Outer Ear consists of

1. The Pinna or external ear.

2. The Meatus or ear canal.

3. The Tympanic membrane or the eardrum.

The eardrum separates outer and middle ears, so it counts as being in both.

The Middle Ear consists of

4. The Tympanic membrane, or eardrum.

5. The Malleus or hammer.

6. The Incus or anvil.

7. The Stapes or stirrup.

The Inner Ear consists of

8. The Cochlea.

THE MIDDLE EAR

The middle ear is a cavity within the temporal bone of the skull.

Ossicles

There are three ossicles: the malleus, the Incus, and the stapes (Figure 2).

Figure 2: OSSICLES

Malleus

The malleus has two main parts: the manubrium and the head. The manubrium also

has two processes: one anterior and one lateral. The region between the manubrium

and the head is called the neck of the malleus.

Incus

The Incus is divided into 3 principal parts: a body and two processes (named short and

long, respectively). The head of the incus articulates with the head of the malleus. At

the end of the long process of the incus is a small region called the lenticular process?

The lenticular process articulates with the head of the stapes. The short process of the

incus is attached to the cavity wall by the posterior incudal ligament.

Stapes

It has four components: a footplate, two crura (posterior and anterior), and a head.

The head of the stapes articulates with the lenticular process of the Incus. The

footplate of the stapes covers the oval window (an opening into the inner ear cavity).

MIDDLE EAR DISEASES

Otosclerosis

It is defined as abnormal bone growth in the ear, eventually resulting in hearing

loss. It can be an inherited disorder, resulting in abnormal hardening of bone in the

middle ear and sometimes inner ear.

Cholesteatoma

Cholesteatoma is a disease of the ear in which a skin cyst grows into the middle ear

and mastoid.

Otitis Media

Otitis media means inflammation of the middle ear. The inflammation occurs as a

result of a middle ear infection. It can occur in one or both ears. Otitis media is the

most frequent diagnosis recorded for children who visit physicians for illness.

Tinnitus

Tinnitus may be a buzzing, ringing, roaring, whistling, or hissing, or it may involve

more complex sounds that vary over time.

1. TITANIUM MATERIALS :

Two of the greatest benefits of titanium are its high strength-to-weight ratio and its

corrosion resistance. Couple this with its non-toxic state and its ability to fight all

corrosion from bodily fluids.

Titanium is also incredibly durable and long-lasting. When titanium cages, rods,

plates and pins are inserted into the body, they can last for upwards of 20 years.

Due to its non-ferromagnetic property, which allows patients with titanium implants

to be safely examined with MRIs and NMRIs.

Osseo-integration is a unique phenomenon where body’s natural bone and

tissue actually bond to the artificial implant. This firmly anchors the titanium

medical implant into place. Titanium is one of the only metals that allows for this

integration.

Fig : Properties of Titanium as a Medical Material

ADVANTAGES OF TITANIUM MATERIALS :

• Excellent biocompatibility (non-toxic AND not rejected by the body).

• High affinity towards bone (Osseo-integrated behavior).

• No inflammation.

• Good acceptance at chronic inflammation site.

• Light weight and delicate structure facilitate excellent intra operative handling.

• High Corrosion stability.

• High rate of success in revision surgery.

• Secure placement.

• High Stiffness of the titanium relates to the optimal adjustment of the implants to

the elastic properties of the bone.

• Low input impedance for good sound reception.

• Balance between Stiffness and Flexibility.

• Faster surgical procedure and enhanced patient safety.

• MRI compatible (Due to Non-ferromagnetic).

• Flexibility and elasticity rivals that of human bone.

2. PTFE MATERIALS :

Polytetrafluoroethylene (PTFE) is a versatile polymer used in a broad range of

medical, industrial, and high technology applications. PTFE is inert, making it

unreactive to most chemicals, and, it can work in high processing and operating

temperature environments (500°F / 260°C continuous).

PTFE offers excellent thermal, electrical, mechanical, and chemical properties as

well as superior control over pore size, permeability, water entry pressure, and

thickness. PTFE is an ideal choice for a wide variety of demanding applications

requiring one or a combination of these exceptional properties.

ADVANTAGES OF PTFE MATERIALS:

• Chemically inert.

• Thermally resistant (500°F / 260°C continuous use).

• Compatible with ultrasonic/thermal welding and inset molding.

• Hydrophobic and oleo phobic.

• Omni-directional flow.

• High tensile strength.

• Steam and ETO (ethylene oxide) sterilizable.

• Natural white or black colour.

3. SILICONE MATERIALS:

Medical grade silicone is silicone with properties that allow it to be safely used in

contact with living tissue, a characteristic called biocompatibility. Silicones are a

group of synthetic polymers used in many medical devices due to their flexibility,

heat resistance, and low toxicity and chemical reactivity. Medical grade silicone is

used in medical devices such as bandages and medical implants.

ADVANTAGES OF SILICONE MATERIALS:

• Much Biocompatible.

• Thermally resistant.

• High flexibility.

• Hydrophobic and oleo phobic.

• Chemically inert.

• Steam and ETO (ethylene oxide) sterilizable.

TITANIUM MIDDLE EAR PROSTHESES

INTRODUCTION

Due to diseases trauma, or congenital malformation, the ossicles of the middle ear are

sometimes damaged. If this damage results in a discontinuity of bone between the

tympanic membrane and oval window, no sound conduction and hearing loss results.

Some or all of these ossicles can be replaced with a small prosthesis. Titanium based

Middle Ear Prosthesis is applied for ossicular replacement or reconstruction of the middle

Ear. Ossicular chain reconstruction is the rebuilding of the middle ear ossicular chain which

has been disrupted or destroyed through the use of some interpositioned device. This is to

regain the original mechanics of the ossicular chain and convert this mechanical energy

into the electrical impulse produced by the cochlea.

These types of Titanium Middle Ear Prosthesis consist of a flat coupling body designed to

rest against the Ear Drum, an oblong shank connected to the body for bridging the

tympanic cavity and a base which is joined to the shank and the rest against the base of

the prosthesis in the tympanic cavity. (Figure 3 & 4)

Figure 3 Figure 4

Figure 3: PORP (Partial Ossicular Replacement Prosthesis)

Figure 4: TORP (Total Ossicular Replacement Prosthesis)

APPLICATION OF MIDDLE EAR PROSTHESES (TORP, PORP) : Ossiculoplasty :

The ossicles are the bones of hearing in the middle ear. They are very effective at

transmitting sound, so damage to them results in quite a large hearing loss. The bones

can be damaged by repeated infections or by head injury, or eaten away by a

cholesteatoma.

Ossicuplasty is an operation to

reconnect the bones of hearing. a cut is

made inside the ear canal so the

eardrum can be lifted for access. The

gap between the damaged ossicles is

bridged by a graft. often, the original

incus bone can be reshaped and

reinserted as the graft, or the graft

may be made of plastic or titanium, or

other small pieces of bone cartilage

taken from ear. The reconstruction can

be done alone oras part of a more

complex operation such as

mastoidectomy.

It may be necessary to stay in hospital overnight, but patient will usually be able to go

home the next day. A lightdressing of gauze or pieces of dissolvable dressing is placed in

the ear canal and is removed in the outpatients department after 1-2 weeks.

The graft does not always stick properly. However, 80% of patients find that their hearing

improves, even if it does not return completely to normal.

There is a small risk that the graft may be rejected if artificial materials such as plastic or

titanium are used. They are slowly expelled from the middle ear and eventually fall out,

even after several years. Same way, there is risk f bone or cartilage being resorbed over

several years, if this happens, hearing gets much worse again, and revision surgery is

required.

APPLICATION OF MIDDLE EAR PROSTHESES (STAPES PISTON) : Stapedectomy : Stapedectomy is an operation to treat hearing loss caused by otosclerosis, a hereditary

condition which causes the stapes bone in the middle ear to fuse in place. the operation is

performed under local anaesthesia and takes about 1-2 hours. patient usually have to stay

in hospital overnight.

A cut is made inside the ear canal so the

eardrum can be lifted and the fused stapes

bone removed. a tiny hole (about 0.5 mm

wide) is drilled into the wall of the inner ear

to hold the end of a replacement 'bone' of

plastic or metal. the hole is sealed with a clot

of blood, a piece of fat from the earlobe, or a

patch of dissolvable dressing. The ear drum

is replaced and finally pieces of dissolvable

dressing is placed in the canal for 1-2 weeks

while the cut heals.

After the operation, there is little discomfort,

though it is common to feel slightly dizzy for

1-2 days. patient may return to work after

about a week, but should avoid heavy lifting, diving and flying for 4-6 weeks.

The operation results in a big improvement in hearing in 85% of cases. Approximately

10% of people get very little benefit from the operation, and in up 5% of people it can

cause a permanent loss of hearing in the operated ear. For this reason, some people

choose to use a hearing aid instead of having the operation. The improvement in hearing

is usually noticed as soon as the dressing is removed from the ear canal. In some cases, it

may take a few days longer.

TITANIUM MIDDLE EAR PROSTHESES

E1101 - Tita-prosthesis type Partial Vario Campana

Tita-prosthesis type Partial Vario Campana is used for

partial ossicular chain reconstruction. It is just Malleus and

Incus replacement to connect Tympanic Membrane and Head

of the Stapes. It consists Head Plate (Disk), Shaft, and

Campana type cup.

Design Benefits:

• Partially roughened surface on upper part of disk and

inside cup stabilizes prosthesis placement.

• Low risk of dislocation because of campana shaped

cup.

• Stable design provides maximum sound output.

• Offers best possible length selection.

• Enhanced view capability during implantation because

of four symmetrical bore holes on disk.

• Due to trimmeble shaft it can be use as per patient’s

Anatomical Requirement.

• Radial outer facing of disk minimizes risk of tympanic

membrane injury.

• MRI Compatible.

REF Shaft Disk Functional Total Length Units per

Number Diameter Diameter Length (L) package

E1101 0.30 3.00 1.75-5.00 5.00 1 pc, Gamma Sterile

E1102 - Tita-prosthesis type Total Vario Cask

Tita-prosthesis type Total Vario Cask is used for

total ossicular chain reconstruction. Total Ossicular chain

replacement to connect Tympanic Membrane and

Footplate of the stapes (At Oval Window). It consists Head

Plate (Disk), Shaft, and Cask type cup.

Design Benefits:

• Partially roughened surface on upper part of disk and

inside cup stabilizes prosthesis placement.



• Enhanced view capability during implantation because

of four symmetrical bore holes on disk.



• Radial outer facing of disk minimizes risk of tympanic

membrane injury.

• MRI Compatible.




E1103 - Tita-prosthesis Piston Type Loop

Tita-prosthesis Piston Type Loop is used for

Stapedioplasty. It is connected between Long process of Incus

and Oval window. It consists Loop (Flat Band) and Piston.

Design Benefits:





• Easy loop introduction.

• Reduced risk of osteonecrosis.

• Atraumatic design (Not produces any Injuries or

Damage).

• MRI Compatible.




E1207 – TitaHAp-prosthesis type Vario Partial (PORP)

A thin layer of Hydroxyapatite (HAP) is coated onto

the top surface of Disk-cylinder for better fixation of

Disk to

Tympanic Membrane (TM).

The HAP coating gives a firmer grip of the

prostheses with the TM. It acts as an intermediate layer

between TM and the titanium disc. The prostheses has

the conducting capabilities of Titanium and the excellent

biocompatibility of HAP which provides excellent

flexibility and comfort for the surgeon.

It consists two units 1) Disk – Cylinder (Coated with Hydroxyapatite) 2) Campana Cup with radial shaft.

Function :

It is a replacement for the malleus & Incus as it connects the TM and the Head of the Stapes. Design Benefits :

• Better fixation of Disk with TM (Fibroblast cell fixation within HAP pores).

• Light Weight compare to conventional HAP prostheses.

• Excellent biocompatibility due to bioactive material.

• Hap Coating on Titanium promote Osseo-integration (the direct structural and functional

Connection between living bone and the surface of an artificial implant).

• Least extrusion due to HAP coating (Dislocation of prosthesis).

• Provides good flexibility.

• Good visibility during implantation of prostheses due to four holes on disk.

• Provides benefits of both: Titanium and Hydroxyapetite (Titanium provides

better conduction and Hap provides better fixation with biological tissues).

• Both Titanium and HAp are biocompatible materials.

• Shaft of PORP is Trimmeable hence it use as per patient anatomical requirement.

• Radial outer facing Disk minimizes risk of tympanic membrane injury.

• Atraumatic Design.

• MRI Compatible.

E1208 – TitaHAp-prosthesis type Vario Total (TORP)

It consists two units 1) Disk – Cylinder (Coated with Hydroxyapatite) . 2) Cask shaped Head with radial shaft.

Function :

It is a replacement for the complete ossicular chain as it connects the TM and the footplate of the stapes (at the oval window).

Design Benefits:

• The Length of the shaft can be cut as per patient’s anatomical requirement and then

shaft inserted into the cylinder on the disk. Hence only one TORP is required for

particular total ossicular reconstruction.

• Better fixation of Disk with TM (Fibroblast cell fixation within HAP pores).

• Light Weight compare to conventional HAP prostheses.

• Excellent biocompatibility due to bioactive material.

• Hap Coating on Titanium promote Osseo-integration (the direct structural and functional

Connection between living bone and the surface of an artificial implant).

• Least extrusion due to HAP coating (Dislocation of prosthesis).

• Provides good flexibility.

• Good visibility during implantation of prostheses due to four holes on disk.

• Provides benefits of both: Titanium and Hydroxyapetite (Titanium provides better

conduction and Hap provides better fixation with biological tissues).

• Both Titanium and HAp are biocompatible materials.

• Radial outer facing Disk minimizes risk of tympanic membrane injury.


• MRI Compatible.

REF Shaft Disk Functional Total Units per

Number Diameter Diameter Length Length (L) package

E1207 0.30 3.00 HAp Coated

1.75-5.00 5.00 1 pc, Gamma Sterile

E1208 0.30 3.00 HAp Coated

3.00-7.00 7.00 1 pc, Gamma Sterile

E4119 – Tita-PTFE Vario Piston type Loop

Function :

Tita-PTFE Vario Piston type Loop replace stapes and then connect long process of Incus and Oval window. (Stapes surgery) Consists : Loop or Flat Band (Titanium) and Shaft (PTFE). Design Benefits:

• Only one OSSEOUS: Tita-PTFE Piston is required due to

best possible length selection.

• Made up of excellent biocompatible Titanium and PTFE

material.


• Easy loop introduction.

• Faster surgical procedure and enhanced patient safety.

• Reduced risk of osteonecrosis (bone death due to poor

blood Supply) because of flat band(loop).

• Reduce Surgery cost.

• Facilitate length selection as per requirement of patient

because shaft is of PTFE material hence it can be easily

trimmed as per required length during surgery using

simple blade or scissor.

• Atraumatic Design (Not produces any kind of Injuries).

• MRI Compatible.

REF Shaft Loop Shaft Functional Length Units per



++

E9131 - Super Titanium Vario Piston type Loop (OSSEOUS: Super Titanium Piston)+ Material: Titanium (Elastic Properties) Medical Grade E9132 - Super Tita-PTFE Vario Piston type Loop (OSSEOUS: Super Tita-PTFE Piston)++ Material: Titanium (Elastic Properties) & PTFE Medical Grade

Flat band loop of Self Crimping Super Titanium material Material Information: Super titanium Piston made up of CP Titanium Medical Grade 2 (ASTM F67) material. A

“Super Titanium” property is because of specialized manufacturing technique at EON

Meditech Pvt. Ltd. After several quality & expertise manufacturing process, we have

achieved special properties of Titanium having elastic properties for self crimping

attachment.

Features:

Insertion of Super Titanium Piston to the long process of Incus is as similar to Self

crimping NITINOL. Unique flat loop design of Super Titanium material provides self

crimping (elastic properties) attachment to Incus and also provides uniform attachment of

loop around total periphery of Incus which reduces the risk of compressive necrosis. A

Superelastic property of loop reduces the surgical process time and crimping difficulties.

• More Elastic Titanium material for self crimping effect.

• Simplified loop introduction to Incus by easy downward movement.

• Elastic self crimping loop shortens the time of surgery.


• Reduced risk of osteonecrosis.

• MRI Compatible.

+

Loop attachment procedure to Incus:

1. The loop attaches to Incus by applying an easy Vertical little force which opens

loop. (Figure 1)

2. The loop will be opened (Figure 2) and again it returns to its original shape due to

its Superelastic properties. (Figure 3)

Figure 1 Figure 2 Figure 3

(Super Titanium Piston – Loop attachment procedure to Incus)

REF Number Item Shaft

Diameter

Loop Shaft

Diameter

Functional Length

Length (L)

Units per package

E9131 Super Titanium Vario

Piston type Loop 0.40 0.20 3.50-5.50 5.50

1 pc, Gamma Sterile

E9132 Super Tita-PTFE Vario

Piston type Loop 0.40 0.20 4.00-6.00 6.00

1 pc, Gamma Sterile

E8130 - Superelastic NITINOL-PTFE Vario Piston type Loop (OSSEOUS: NITINOL-PTFE Piston)

Flat band loop with Super Elastic NITINOL material Material: Super Elastic NITINOL & PTFE Medical Grade

Figure 1 Figure 2 Figure 3

(Superelastic NITINOL Piston – Loop attachment procedure to Incus) Features:

Unique flat loop design of Superelastic NITINOL material provides self crimping attachment

to Incus and also provides uniform attachment of loop around total periphery of Incus

which reduces the risk of compressive necrosis. A Superelastic property of loop reduces

the surgical process time and crimping difficulties.

Loop attachment procedure to Incus:

3. The loop attaches to Incus by applying an easy Vertical little force which opens

loop. (Figure 1)

4. The loop will be opened (Figure 2) and again it returns to its original shape due to

its Superelastic properties. (Figure 3)

REF Number

Shaft Diameter

Loop Shaft Diameter

Functional Length

Length (L)

Units per package

E8130 0.40 0.20 4.00-5.50 5.50 1 pc, Gamma

Sterile

PTFE MIDDLE EAR PROSTHESES

E3133 - PTFE Partial Prostheses (PORP)

Design Benefits:

• Much Biocompatible with biological tissues.

• Easily Trimmeble from 5.00 mm to 2.00 mm in length.

• Reduce surgery cost.

• Conventional design.

REF Number

Shaft Diameter

OD/ID Disk Diameter

Functional Length

Total Length (L)

Units per package

E2133 2.00/1.20 hollow, partially

4.00 5.00 – 2.00 5.00 1 pc, ETO Sterile

E3134 - PTFE Total Prostheses (TORP)

Design Benefits:


• Easily Trimmeble from 7.00 mm to 3.00 mm in length.

• Reduce surgery cost.

• Conventional design.

REF Shaft Flange Functional Total Length Units per


E2134 1.00 3.00 7.00 - 3.00 7.00 1 pc, ETO Sterile

PTFE Stapes Piston Using smooth jaw alligator forceps, the piston loop can be expanded with a pick to slip

over the Incus.

Design Benefits:

• "Plastic memory" provides secure closure.

• Conventional design for easy attachment with Long

process of Incus.

• Can be easily trimmed with scissor or cutting tool from

6.00 mm to 3.50 mm.


REF Piston Loop Inner Functional Length Units per Number Diameter Diameter Length (L) package

E2127 0.50 0.60 3.50-6.00 6.00 1 pc, ETO Sterile

E2128 0.40 0.60 3.50-6.00 6.00 1 pc, ETO Sterile

E2129 0.60 0.60 3.50-6.00 6.00 1 pc, ETO Sterile

MIDDLE EAR RELATED INSTRUMENTS (OSSEOUS INSTRUMENTS)

OSSOUES CUTTER

Osseous cutter is used to trim the Osseous Surgical

implants to optimal length in accordance with the

patient's anatomical condition and surgical

requirement. The following prostheses can be trimmed

using this cutter:

• Tita-prostheses type Partial Vario Campana

• Tita-prostheses type Total Vario Cask

• Tita-Prostheses Piston Type Loop

INSTRUCTIONS FOR OSSOUES CUTTER The purpose of these instructions is to make the handling of the OSSEOUS Cutter and implants as easy and simple as possible for all operating room staff using EON’s OSSEOUS surgical implants. Osseous Cutter is having 3 parts:

A) Cutting Block B) Lever C) Shortening Blade

A) Cutting Block consists: (1) Station for Disk (For Partial Cup or Total Cup Assembly with Disk) (2) Station for Stapes Piston for easy handling.

B) Lever is having sharp edge for cutting the prostheses.

C) Shortening Blade consists: (1) various length steps from 1.50 mm to 5.00 mm (Hole Length - H.L.) (2) Two holes on each steps (0.4 mm dia for Stapes Piston & 0.3 mm dia for Partial Cup and Total Cup)

(Figure 1: OSSEOUS CUTTER)

A

B C

A

B

C

CUTTING ACTION Partial Cup/Total Cup/Stapes Piston can be easily trimmed using OSSEOUS Cutter by just pressing the lever down as shown in figure 2.

Cutting PORP The required length is exact the length of Hole (H.L.). Means if 3.5 mm length of Partial Cup required, Surgeons can easily insert Partial Cup into 3.5 mm Hole and cut excess length by just pressing down the lever. (Figure 3) Cutting TORP The required length is Hole Length (H.L.) + 1.00 mm. Means if 4.5 mm length of Total Cup required, Surgeons can easily insert Total Cup into 3.5 mm Hole and cut excess length by just pressing down the lever. So the length will be 3.5 mm + 1.0 mm i.e. 4.5 mm. (Figure 4) Cutting Stapes Piston The required length is exact the length of Hole (H.L.). Means if 4.25 mm length of Piston required, Surgeons can easily insert Piston into 4.25 mm Hole and cut excess length by just pressing down the lever. (Figure 5)

(Figure 3: Inserting PORP & Excessive length comes out from shortening Blade)

(Figure 4: Inserting TORP & Excessive length comes out from shortening Blade)

(Figure 2: Cutting action using lever)

(Figure 4: Inserting Piston & Excessive length comes out from shortening Blade)

(Figure 5: Stations for Disk & Stapes Piston for easy handling) IMPORTANT NOTE: One or two drops of sterile NaCl 0.9% should be placed on the shaft

of Partial Cup / Total Cup / Stapes Piston & nearby shortening blade, all stations.

OSSEOUS SIZER

Osseous Sizer is used to measure the distance between

any two points in the middle ear cavity which is to be

connected using prosthesis. For instance, In a

Stapedioplasty surgery the exact distance between the

long process of the Incus and the footplate can be

measured using the Osseous Sizer and accordingly the

Osseous surgical implants can be trimmed using

Osseous cutter (REF: EI01).

INSTRUCTIONS FOR OSSOUES SIZER

OSSEOUS Sizer is equipped with a pointer for the precise measurement of prostheses for middle ear reconstruction and tympanoplasty. In order to measure the distance between two points during surgery, hold the instrument like as a pen and position the tab at the end of the needle at the level of the first point. With your index finger push the button until the mandrel coming out of the needle reaches the second point. Distances are indicated in millimeters on the instrument's handle. This instrument is made completely of stainless steel which can be sterilized or autoclaved. PARTIAL/ TOTAL OSSICULAR CHAIN RECONSTRUCTION First Point: Near By Tympanic Membrane Second Point: Stapes Head (Partial Prosthesis) or Footplate of the Stapes (Total Prosthesis)

1) Hold the Osseous Sizer like as pen and Put the needle of the measuring device in a position perpendicular to the footplate with the tab at the same level as Tympanic Membrane.

2) With your index finger push the button until the mandrel coming out of the needle reaches the second

point. (Figure 6: OSSEOUS SIZER)

3) Pull the measuring device out and, read the measured distance on the graduated

section on the handle. 4) Required prosthesis length:

• Partial Prosthesis – Distance between Tympanic Membrane and Stapes Head. • Total Prosthesis – Distance between Tympanic Membrane and Footplate of

Stapes plus the depth into the fenestration. 5) Distances are indicated in millimeters on the instrument's handle. 6) Appropriately cut the prostheses in “Osseous Cutter” as per measurement.

STAPES SURGERY First point: Under the long process of the Incus (Medial Side) Second point: Footplate of the Stapes

1. Hold the Osseous Sizer like as pen and Put the needle of the measuring device in a position perpendicular to the footplate with the tab at the same level as under the long process of the incus (Medial Side).

2. With your index finger push the button until the mandrel coming out of the needle reaches the second point.

3. Pull the measuring device out and, read the measured distance on the graduated section on the handle.

4. Required prosthesis length: • PISTON – Distance between long process of the Incus (Medial Side) and

Footplate of the Stapes plus the depth into the fenestration. 5. Distances are indicated in millimeters on the instrument's handle. 6. Appropriately cut the Piston in “Osseous Cutter” as per measurement.

(Figure 7: OSSEOUS SIZER How to measure)

REF Point

VENTILATION TUBES (TITANIUM, PTFE & SILICONE) :

What are Ear Ventilation Tubes?

Vent tubes for the ear are generally only a few millimeters wide.

Fluid trapped behind the eardrum is a breeding ground for

bacteria and infection. An ear ventilation tube (or vent tube) is

a very small tube that’s placed in the eardrum. It’s also called

a myringotomy tube, tympanostomy tube, or pressure

equalization (PE) tube. Vent tubes let fluid trapped behind the

eardrum drain, which helps prevent ear infections (otitis

media).

The operation to insert a vent tube is very safe, simple, and quick. The ENT (ear, nose,

and throat) specialist or ear specialist makes a very small cut in the eardrum and puts a

vent tube in one or both ears. The vent tubes cause no pain or hearing loss.

Why is ventilation tube needed?

A child’s Eustachian tubes sometimes can't drain fluid away from the middle ear into the

throat very well. If fluid builds up behind the eardrum, bacteria can grow. This is how ear

infections begin. After an ear

infection is gone, fluid often

remains behind the eardrum.

A very small ear ventilation

tube (vent tube) is put into

the eardrum to allow fluid

drainage and help prevent

further infections.

Detail - Normal ear Detail - Infected middle ear

What is the Eustachian tube?

The Eustachian tube is a canal that runs from the middle part of each ear to the back of

the throat. It does two things. First, it keeps the air pressure inside the middle ear the

same as the air pressure outside the ear. This helps you hear better. Second, it helps fluid

from the middle ear drain into the throat.

In young children, the Eustachian tube is smaller, narrower, and more horizontal. This

makes it easier for germs to move from the throat to the ear and for the tube to become

blocked. Most children stop having ear infections around age 6 because their Eustachian

tubes are more fully developed.

What are the benefits of a ventilation tube?

A vent tube lets fluid drain out of the middle ear, which reduces the chance of ear

infections coming back. It is a very common and standard procedure with little risk.

When should a ventilation tube be used?

A vent tube is usually recommended if your child has several of the following conditions:

• There's been fluid in the middle ear continuously for over 4 months

• There's fluid in both ears

• Recurrent ear infections haven’t responded to continuous antibiotic treatment for

several months

Benefits and Risks – Ventilation Tubes

The risks and benefits of an ear ventilation tube (vent tube) are different for each child.

It’s important to get the answers you need from your pediatrician and ENT or ear

specialist.

Benefits:

• Reduced risk of future ear infections.

• Restored hearing in some children who’ve had hearing problems.

• Allows time for the child’s Eustachian tube to mature and work more effectively. As

a child grows, the Eustachian tube gets longer and wider so it can provide better

drainage of fluid from the ears.

• It’s a very common and quick procedure.

Risks

Some of the risks include:

• Some children may continue to get ear infections, in spite of a vent tube.

• The tube may come out. A vent tube usually falls out in about a year. If it falls out

sooner, it may need to be replaced. Occasionally, the vent tube becomes stuck in

the middle ear. When this happens, it has to be removed by your doctor.

• If the vent tube doesn’t fall out on its own, a surgeon may have to remove it.

• It may leave a small scar on the eardrum, which could cause some hearing loss.

• After the vent tube falls out, a small hole may remain in the eardrum, which might

have to be repaired by your doctor.

Application of Ventilation Tube:

Tympanoplasty

Tympanoplasty is an operation to repair holes (perforations) in the eardrum. It is usually performed under local anaesthesia, but in uncooperative or very anxious patients should be performed under general anaesthesia. It usually takes 1-3 hours depending on other a procedure like ossiculoplasty is required.

A cut is normally made in the

skin crease just behind or just in front of the ear. Often a small amount of hair is shaved off immediately beside the ear. a piece of tissue called a graft is used to patch the eardrum. This graft is normally taken from tissue called fascia that lies just under the skin behind the ear.

The ear drum with some canal

skin is lifted up, and the graft is placed on underside of the hole (inlay) and held in position with small pieces of dissolvable packing. Graft can be placed over the ramnent of ear drum (onlay) or in between the layers of ear drum (interlay). A gauze wick or the same dissolvable material fills the ear canal forwards to protect the ear drum and is removed 1-2 weeks later in outpatient department.

After the operation, there is little discomfort. Any pain is easily controlled with

painkillers. It is quite common to feel slight dizzy for 1-2 days. Most patients go home the same day or the day after surgery. it is best to take about 7 days off work. Patient should not get any water in the ear and should avoid swimming and flying for at least 4 weeks.

The graft fails to take in about 10-20 % of cases. the operation can be repeated if

this happens. If the eardrum heals successfully hearing should improve, though it may not return completely to normal.

Titanium Ventilation Tubes

Tita-prosthesis Vent Tube Type Collar Button

Tita-prosthesis Vent Tube Type Collar Button is used for

implantation in the tympanic membrane to drain and

temporarily aerate the tympanic cavity.

Design Benefits:

• Excellent tissue biocompatibility.

• Antibacterial effect.

• Long-term durability.

• Smooth surfaces that facilitate secretion drainage.

• Simple implantation.


• MRI Compatible.

REF Inner Inner Flange Outer Flange Units per Number Diameter Diameter Diameter package

E1104 1.40 2.55 2.55 1 pc, Gamma Sterile



PTFE Ventilation Tubes

E2124 – Donaldson

Features:

• Short term ventilation tube

• Dual Flange provides good migration and

extrusion resistance.

• Its easy-to-use design has made this one of

the most popular types of ventilation tubes.

REF Inner Inner Flange Outer Flange Total Units per Number Diameter Diameter Diameter Length package

E2124 1.14 2.30 2.30 2.20 1 pc, ETO Sterile

E2123 & E2125 – Collar Button

Features:

• Classic Design.

• Midterm ventilation tube.

• A larger inner diameter reduces the risk of

occlusion.

REF Inner Inner Flange Outer Flange Total Units per

Number Diameter Diameter Diameter Length package

E2123 1.27 3.00 3.00 2.15 1 pc, ETO

Sterile

E2125 1.14 2.30 2.30 2.15 1 pc, ETO

Sterile

E2112 & E2113 – Shah & Mini Shah

Features:

•Mid term ventilation tube.

•Good extrusion resistance.



E2112 1.14 3.40 2.30 2.40 1 pc, ETO

Sterile

E2113 0.76 2.20 1.50 1.50 1 pc, ETO

Sterile

E2114 – Shepard

Features:

• Classic popular grommet design for easy

insertion, adequate ventilation and short

term duration. Available in Fluoroplastic.

• A popular short-term ventilation tube.

• Available with and without tail.

• The average extrusion time was 8.5 ± 4.6

months for Shepard tubes.



E2114 1.14 2.40 2.40 2.20 1 pc, ETO

Sterile

E2116 – Straight Tube

Features:

• Smaller inner flange (Smaller inner flange

facilitates insertion in a smaller incision).

• Longer shaft lengths may help resist water

migration into the middle ear.

• Can be trimmed to length.

• Available both for short-term and long- term use, with different flange diameters.

• The tube for long-term use has a larger outer flange diameter,

preventing the tube from an early extrusion.

REF Inner Inner Flange Outer Flange Total No. of Pcs/

Number Diameter Diameter Diameter Length Package

E2116 1.14 2.70 - 7.25 1 pc, ETO

Sterile

E2117 – Bevel Bobbin

Features:

• The bell-shaped outer flange improves

ventilation and helps viewing through

the lumen.

• Designed to enhance retention and aeration.

• The tapered lumen assists the surgeon in

cleaning if necessary.

• Combining the best features of the Baxter

Bevel Button and the Reuter Bobbin, the

beveled shape resists occlusion and clears easily.


• Excellent secretion drainage

REF Inner Inner Flange Outer Flange Total No. of Pcs/ Number Diameter Diameter Diameter Length Package

E2117 1.14 2.80 2.80 1.70 1 pc, ETO

Sterile

E2136 – Baxter Beveled Bobbin

Features:

• Combine features of Bevel Bobbin and the

Reuter Bobbin.




E2136 1.27 2.80 2.80 2.20 1 pc, ETO

Sterile

E2137 – Reuter Bobbin

Features:

• Classic Design.


• It has an excellent history of providing a

somewhat longer duration for middle ear

ventilation.



E2137 1.14 2.30 2.30 1.60 1 pc, ETO

Sterile

E2109 – Armstrong

Features:

• Mid-term ventilation tube.

• Beveled inner flange (The beveled inner

flange is angled to the shank, which allows

easier insertion and keeps the tube parallel to

the auditory canal.

• Better visibility through tube & Good

extrusion resistance.

REF Inner Inner Flange Outer Flange Total Units per Number Diameter Diameter Diameter Length Package

E2109 1.14 2.5 2.5 3.8 1 pc, ETO

Sterile

E2110 – Modified Armstrong

Features:

• Mid-tern ventilation tube.

• Beveled Inner Flange.

• Good extrusion resistance and easier

insertion.



E2110 1.14 2.5 2.5 2.3 1 pc, ETO

Sterile

Silicone Ventilation Tubes

E3111 – Donaldson

Its easy-to-use design has made this one of the most popular types of ventilation tubes.

The silicone version can be compressed for easy insertion.

Features:

• The large lumen offers good ventilation

and the dual flange design resists

migration and extrusion.

• Short term ventilation tube.



E3111 1.10 2.30 2.30 2.20 1 pc, ETO

Sterile

E3126 – Paparella

Unique design of notched inner flange facilitates insertion through simple "twist-in"

movement. Very stable for short-term implantation. Integral tab for removal with forceps.

This tube is conveniently rotated into position by introducing the lead corner of the flange

into the myringotomy.

Features:

• Notched inner flange is designed for easier

insertion in a smaller incision.

• Short-term ventilation tube.

REF Inner Inner Flange Outer Flange Total Units per Number Diameter Diameter Diameter Length Package

E3126 1.14 2.40 2.10 2.20 1 pc, ETO

Sterile

E3115 – T-Tube

The soft large flanges prevent the tube from extrusion. The tube is easily inserted with the

T-tube inserter. The 12 mm tube can be cut to desired length. A T-tube has two flanges

and is composed of medical grade

silicone. T-tubes are inserted

when long-term ventilation is

required. T-tubes usually remain

in the eardrum for 24 months or

longer. If T-tubes are retained

and are not spontaneously

ejected, they may be removed

and the eardrum may be repaired

with a fat graft or other tissue

(fascia or cartilage).

Features:

• Long-term ventilation tube.

• Shafts and flanges can be partly shortened.

• Proven and popular design.

• Soft flanges open out after insertion into ear drum.

• Opened flanges prevent premature loss.

REF Inner Outer Flange Flange Total No. of Pcs/

Number Diameter Diameter Width Length Package

E3115S 1.14 1.70 8.00 6.00 1 pc, ETO

Sterile

E3115M 1.14 1.70 8.00 9.00 1 pc, ETO

Sterile

E3115L 1.14 1.70 8.00 12.00 1 pc, ETO

Sterile

EAR PVA DRESSINGS

Ear Wick: Soft and resilient, Osseous ear wicks are designed to aid the treatment of otitis

externa. They deliver medication, such as an antibiotics solution, to the ear canal and the

ear canal membrane.

Osseous ear wicks are designed to deliver antibiotics during the treament of otitis externa.

• Perfect Design to use in treatments for otitis externa

• Deliver medication to ear canal

• Fenestrated variety available

Ear Pack: Designed for use in otic surgery, Osseous ear packs help absorb fluids during

surgery. The soft and porous PVA foam material expands evenly to support the ear canal

after surgery. Osseous ear packs are sterile and come with rounded edges for quick and

easy insertion.

Osseous ear packs are designed for use in otic surgery. They absorb fluids and support

canals after surgery.

• Helps prevent stenosis of the ear canal

• Porous foam for rapid absorption

REF

Number Product Name Specification Product Description Units per

package

E7161 Ear wick Ø 9.0mm x 15.0mm No string 10 pcs,

Gamma Sterile


Gamma Sterile


Gamma Sterile


Gamma Sterile

E7165 Ear Pack Ø 9.0mm x 15.0mm With String 10 pcs,

Gamma Sterile


Gamma Sterile


Gamma Sterile


Gamma Sterile

E7169 Ear wick Ø 9.0mm x 15.0mm Fenestrated 10 pcs,

Gamma Sterile

E7170 Ear wick Ø 9.0mm x 24.0mm Fenestrated 10 pcs,

Gamma Sterile

STANDARD NASAL DRESSINGS

Osseous standard nasal packs are designed for use in a variety of nasal surgeries:

septoplasty, turbinectomy, rhinoplasty, and more. They fill and support nasal cavities

during surgery, allowing smooth septum ventilation to ensure patient comfort. Osseous

nasal packs also absorb post-operative bleeding effectively and efficiently. They are

available with or without String and airway tube.

Standard packs are used in a variety of nasal surgeries to support nasal cavities and

effectively stop nose bleeding.

• Designed for nasal surgeries

• Gentle compression to stop bleeding and absorb blood

• Excellent alternative to cumbersome gauze packing

REF

Number Product Name

Specification Product Description Units per package

E7176 Nasal

Dressing 4.5cm x1.5cm x2.0cm No string

10 pcs, Gamma Sterile

E7177 Nasal

Dressing 4.5cm x1.5cm x2.0cm With String


E7178 Nasal

Dressing 4.5cm x1.5cm x2.0cm With String & Tube


E7179 Nasal

Dressing 4.5cm x1.0cm x2.0cm Thin


E7180 Nasal

Dressing 8.0cm x1.5cm x2.0cm No string


E7181 Nasal



E7182 Nasal



E7183 Nasal



ANATOMICAL NASAL DRESSINGS

Designed to fill the nasal cavity, Osseous anatomical nasal packs are used during and after

nasal surgery. With optional airway tube, they enhance patient comfort by ensuring easy

breathing. Moderately-sized, and with soft yet supportive texture for easy placement and

removal, Osseous anatomical packs effectively reduce patient discomfort.

Anatomical packs are used during and after nasal surgery to support nasal cavities and

facilitate proper breathing.

• Support the nasal cavity after surgery


REF

Number Product Name Specification Product Description Units per package

E7188 Anatomical Nasal









EPISTAXIS NASAL DRESSINGS

Osseous epistaxis nasal packs are used in the treatment of anterior and posterior nose

bleeding. The soft round edges create less friction and reduce irritation during nasal

passage insertion. The epistaxis packs expand to gently compress and effectively stop

nose bleeding.

Epistaxis packs stop nosebleeds, safely and effectively.

• Designed to treat nosebleeds

• Softness reduces irritation

• Quick and uniform expansion

• Fluid absorption causes the packing to expand producing a tamponading effect

REF


E7184 Epistaxis Nasal

Dressing 10.0cm x1.5cm x2.5cm No String











SINUS PACKS

Osseous sinus packs are made with soft, porous, resilient PVA foam. They are designed to

support the sinus cavity and the osteomeatal complex to ensure airflow through nose.

They also expand to stop bleeding through gentle compression, and facilitate faster

recovery. They have rounded edges to allow easy insertion during surgery, and provide

comfort even during removal.

Sinus packs are designed for use after sinus surgery, to ensure proper breathing.

• Ideal for FESS (Functional Endoscopic Sinus Surgery) sinus surgery

• Reduce bleeding and facilitate healing

• Allows the sinus cavity to remain open while absorbing post-operative fluids

• Fine pore construction reduces tissue adherence


REF


E7191 Sinus Pack 3.5cm x1.2cm x0.6cm With String 10 pcs,

Gamma Sterile

E7192 Sinus Pack 3.5cm x1.2cm x0.9cm With String 10 pcs,

Gamma Sterile

Common Advantages for all kind of Osseous PVA dressings:

• Lint and fiber-free • Sterilized by gamma radiation • Packaged in clean-room facilities • Excellent alternative to cumbersome gauze packing • All products have good biocompatibility, low antigenicity, tissue reaction and

transmissibility.

403, B Tower, Diamond World, Mangadh Chowk, Varachha Road, Surat-395006, Gujarat, India. Phone: +91 261 3072190. E-mail ID: [email protected] [email protected] www.eonmeditech.com

Date post:	14-Aug-2015
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