Cost Effective Surgery Bone Mill in the Market

Patent 8, 857, 749 B2

BIO-SAV BONE MILL GUIDE

The Bio-Sav Bone Mill is...

Consistant

Easy to use

Required minimal effort:

Expedites and optimizes preparation of allograph and autograph bone material
Low risk operator injury

Precise yield of bone every process:

Uniform pulverization of bone with repeatable bone preparation
100% reclamation of bone yield
Preserves efficacy of bone during size reduction process

Disposable

Single use bone mill:

No maintenance or sterilization costs
Eliminate risk of cross- contamination

Compact

Pre-assembled bone mill:

No assembly time required and no need for power source
Takes up little space on back table

PROBLEM

Spinal Fusion typically includes a patient’s bone to be harvested for reintroduction into the patient at a later time during surgery. Reducing harvested bone is often technically cumbersome and time consuming in current systems, and problematic in the preservation of its efficacy when surgeries, particularly complex surgeries, demand consistent sized efficacious harvested bone.

Powered bone mill solutions are currently the most commonly employed solutions for reducing harvested bone in the market. Yet these powered bone mills very often prove unreliable because they deliver inconsistent sized bone with possible efficacy issues such as potential bone overheating.

SOLUTION

The Bio-Sav Bone MillTM is the first large case disposable bone mill that ensures maximum safety for both the OR staff and patient, where cell viability within the bone particulate is preserved, where bone particulate is optimally sized every time, and where this recognized cost competitive solution for hospitals helps reduce its OR product spend on a per procedure basis.

RESULTS

SAVES on back table OR support time as a single pass system.
REDUCES general overhead costs versus products that require re-sterilization between surgeries.
PRESERVES bone particulate efficacy for scaffolding purposes.
PREVENTS cross contamination issues akin to capital equipment type bone mills.
OFFERS a new milling option when large case bone harvesting surgeries are scheduled.

Before

After

Features and Benefits

Bio-Sav Bone MillTM is a single-use, disposable bone mill designed to provide reliable efficacious prepared autograft or autograft/allograft scaffold material combinations for orthopedic reconstruction. Applications include Arthoplasty Revisions in Spine, Total Joints and other Orthopedic procedures including Maxillofacial Reconstructions and Trauma where the patient’s bone is being harvested.

Key Features

READY FOR USE -- No down time due to cleaning, assembling or re-sterilization.

STERILE -- Single use, disposability ensuring product is sterile and free from previous surgery cross contamination.

ERGONOMIC FOOTPRINT -- Intuitive design, minimizes operator fatigue and minimizes required space on the surgical back table.

CONTRA ROTATION MILLING DEVICE -- A patented mechanical metal on bone milling process that ideally reduces large bone to scaffold ready autograft.

Benefits

AFFORDABLE – Low barrier pricing for hospitals to procure this product including no upfront capital equipment investments.

ZERO MAINTENANCE -- There are no follow-on maintenance costs when using this product in an OR setting.

AN EXACTING PRODUCT – This product consistently reduces bone to a particulate size (i.e. 1 to 3-mm) that is ideal for graft scaffolding.

INTUITIVE AND EASY TO USE -- Working with this bone mill atop a sterile back table there is little table space required for its operations. The operator simply places the prepared graft material into the bone mill chamber, applies slight downward pressure onto the plunger while turning the milling wheel. The reduced bone drops into the tray below where the particulate is ready for immediate use in the patient.

OPERATOR AND PATIENT PROTECTION -- The complexity and high costs of mills currently in the market often do no justice to the bone being reduced where the particulate is inconsistent in size and quality, as well as exposing the operator to questionable safety factors. Bio-Sav is an operator friendly product that provides a safe experience for the operator. It is a single use product that guarantees a high standard of sterility to protect each patient. The housing design also mitigates glove tears or other type sharp injuries during its operation.

INDICATIONS The Bio-Sav Bone MillTM is indicated and recommended for to following uses: * Any surgical procedure where fusion, reconstruction, or orthopedic arthroplasty revisions are to be performed. *Any Maxillofacial reconstructions that are performed *Any surgical procedure where allograft, autograft and/or other osteo-inductive or conductive materials needs preparation, mixed or ground into an optimized size and consistency to enhance grafting surface area, vascular in-growth and conformability to act as a fusion locus, substrate or void/gap filing material. CONTRAINDICATIONS Use of this product is contraindicated where the use of autograft, allograft or other osteo-inductive and conductive materials may be contraindicated including cases of severe osteopenia or osteoporosis. ADVERSE EFFECTS Use of the product on demineralized osteopenic or osteoporotic bone may yield product too finely pulverized for optimal use. In this case test a small amount of bone to determine sufficient structural integrity. WARNINGS & PRECAUTIONS Do not use this product if the inner packaging has been breached in any manner prior to its usage – prematurely opened or damaged. Do not use this product in a manner inconsistent with product labeling. This device is a single patient use product. As with any surgical procedure, care should be exercised in treating those individuals with underlying pre-existing medical conditions that may affect the surgical success of the procedure. This includes, but is not limited to, those individuals with diabetes, malnutrition, tobacco product use, steroid or non-steriodal anti-inflammatory use (NSAIDS), high dose radiation therapy and or other pathology that may increase surgical risk or affect surgical outcomes and fusion success rates. Use of this product according to its labeling does not constitute any guarantee or warranty, either implied or in writing, with respect to a surgical outcome, fusion rates, or durability of such outcomes. Federal Law (US) restricts this device only to be sold by or on the order of a physician. For Additional Information: Contact your local Bio-Sav Bone Mill Sales Representative

Often asked Questions about The Bio-Save Bone MillTM

Q. Why is the Bio-Sav only used one time?

As a single-use device it was designed predominantly to be the safest most cost effective large case bone mill in the market, and to that end the product was designed intentionally to not be re-sterilized via traditional hospital methods.

Q. What kind of surgeries is best suited for the Bio-Sav Bone MillTM?

Any mid-sized to large case surgeries that require harvested bone graft material. Applications include Complex Spine, Total Joint, Trauma, Maxillofacial orthopedic procedures where bone harvesting is required. As an example, during a multi-level spine procedure where local patient bone is harvested for a 2-level lumbar fusion via an open or minimally invasive procedure the Bio-Sav Bone MillTM is ideal for the bone harvesting procedure. The Bio-Sav Bone MillTM which is a ready to use product is also ideal for unplanned Trauma reconstructive surgeries as well.

Q. Why is the Tray called a Portion Control Bone Tray?

Because inside the Bio-Sav Bone MillTM Tray there is a mid-line rib that allows the surgeon to visually allocate equal parts of harvested particulate bone when such an apportionment is needed (i.e. 2-Level Fusion).

Q. Can The Bio-Sav Bone MillTM be use to mix autograft with other outside Osteobiologics?

Absolutely! It is an ideal mixing system to create uniform biologic mixes of autograft and other supplemental bone products. There is no excessive heat generated during the milling process nor excessive blunt force imposed of the stem cells of the bone due to high speed rotating blades. The low speed cutting process of the Bio-Sav Bone Mill provides optimal bone size for scaffolding while preserving bone efficacy versus its competitors in the market.

Q. What size particulate will be generated by the Bio-Sav Bone MillTM, and is there percentage of bone lost during the bone reduction process?

The Bio-Sav creates an ideal bone particulate that is sized between 1 and 3-mm length where there is little bone loss when the processed bone finds its way into the Bone Portion Management Tray.

Q. Is the Bio-Sav Bone Mill FDA approved?

Bio-Sav is an FDA registered Class I Medical Device.

Q. How easy is the Bio-Sav Bone MillTM to use in a tense OR setting?

The product was designed as an intuitive easy to use product in part to support Trauma Orthopedic procedures. This product is a single use bone mill that is available for use right out of the box! Certainly training is available through local representation, via a training video on this website, and or thru other handout information that can be downloaded from this website.

Q. Can a distributor get involved with representing the Bio-Sav Bone MillTM in his/her respective local marketplace?

MD3 works with competent distributors throughout parts of the US and abroad. If you are a distributor and have an interest in representing this exciting new product, please contact us. We can discuss our different sales representation options to determine what best suits the needs of your organization.