Patent Description:
The present invention relates to devices for harvesting and processing bone and/or cellular material for use in various medical treatments.

Pseudarthrosis, also referred to as non-union of bone, is a common complication of fracture treatment. Non-union occurs when a particular patient's fracture site fails to heal within a specified period of time, and thus requires an intervention (e.g., surgical) in order to achieve proper union and mobility. In some cases, non-unions may be treated by bone grafting (e.g., allograft, autograft, or xenograft), through internal or external fixation, or a combination thereof. Bone grafting offers an opportunity to stimulate the fracture site so that bony formation occurs at the site to properly unionize the fracture.

Stem cells (e.g., Mesenchymal stem cells (MSCs), hematopoietic stem cells (HSCs), or other stem cells) are known to be useful with certain graft materials, or by themselves, to facilitate bone growth and formation when used appropriately. For example, adult MSCs are capable of differentiating into a variety of different cell types including osteoblasts (bone cells), chondrocytes (cartilage cells), and adipocytes (fat cells). As such, when incorporated with certain allograft material, stem cells can assist with the proper formation of bone and union of bone parts at a fracture site. Stem cells of the type discussed above must first be extracted from a patient and processed before use. As an example, extracted bone marrow of a patient can provide the necessary stem cells.

Bone marrow is typically extracted in a multi-staged procedure. In a first stage of the procedure, bone marrow is aspirated from a patient and then sent to a laboratory for processing. It is only then, in a second stage of the procedure, that the previously harvested bone marrow is processed for the patient's particular application. Bone marrow from the iliac crest is widely considered the "gold standard" for its superior biologic quality. The drawback of harvesting bone marrow from the iliac crest, however, is that the iliac crest naturally produces a limited quantity of marrow. For surgical interventions requiring a higher volume of bone marrow, such as trauma and orthopedic applications, bone marrow is often harvested from the medullary canal of a long bone (e.g., the femur or tibia), which naturally produces a higher volume of bone marrow than the iliac crest. Bone marrow harvested from the medullary canal has proven to be an effective alternative to bone marrow harvested from the iliac crest and is capable of providing significant regenerative potential.

In order to harvest the desired volume of marrow from the medullary canal, a surgeon must access and aspirate bone marrow located deep within the bone canal. This procedure is often performed using a harvesting system that is typically equipped with a reamer, an irrigation system, a suction source (OR suction) and a filter. Although these systems are generally sufficient in harvesting the desired bone material, they are aggressive and carry significant clinical risks such as severe blood loss that often necessitates blood transfusion treatments. In fact, while the medical community appreciates the regenerative potential of bone marrow harvested from the medullary canal of long bone, some medical professionals have begun to question whether harvesting the autograft materials is worth the significant clinical risks.

<CIT> discloses a bone harvesting device for extraction of bone and/or cellular material from a patient during a surgical procedure, comprising a main body defining an internal cavity including a suction port adapted to be coupled to a suction source and an aspiration assembly.

Known harvesting devices are also susceptible to clogging, which results in decreased aspiration function, especially while positioned deep within the medullary canal. Moreover, the harvested material is often diluted and/or contaminated by the water or other solution introduced by the irrigation system. Such dilution or contamination complicates the processing stage of the procedure and necessitates additional filtering or refining of the harvest. Therefore, new and improved bone harvesting devices and methods that address these shortcomings are desired.

In accordance with a first aspect of the present invention, a device for harvesting bone and/or cellular material (e.g., cancellous bone, bone chips, bone marrow, and stem cells) for use in various medical applications as claimed in claim <NUM> is provided. Among other advantages, the device includes a dual tubed aspiration assembly that reduces clogging and improves aspiration efficiency. In part, due to the improved aspiration efficiency, the device is capable of performing clog-free transportation of even highly viscous material without the irrigation of fluids. As a result, the need for subsequent filtering and excessive processing is eliminated. Furthermore, the improved aspiration function reduces the surgeon's impulse to aggressively drill into the bone and, in turn, reduces the likelihood of severe blood loss and the clinical complications associated with sever blood loss.

One embodiment of the bone harvesting device includes a main body having an internal cavity and a suction port adapted to be coupled to a suction source, an outer tube having an inner surface, an outer surface, a proximal end and a distal end, the proximal end of the outer tube being coupleable to the main body, an inner tube having an inner surface, an outer surface, a proximal end and a distal end, the inner tube being coupleable to the main body and at least partially disposed within the outer tube such that the inner tube is in fluid communication with the internal cavity, and a storage container coupleable to the main body such that the storage container is in fluid communication with the internal cavity for receiving bone and/or cellular material extracted from the patient.

In some embodiments, the storage container includes an outer sidewall extending from a base end to a top end, and an inner sidewall at least partially disposed within the outer sidewall and being concave with respect to the top end, the inner sidewall defining a collection space for receiving the extracted bone and/or cellular material. At least a portion of the inner sidewall is spaced a distance from the outer sidewall.

In another embodiment, the bone harvesting device may include a body having an internal cavity and a suction port adapted to be coupled to a suction source, an outer tube having an inner surface, an outer surface, a proximal end and a distal end, the proximal end of the outer tube being coupleable to the body, and an inner tube having an inner surface, an outer surface, a proximal end and a distal end. The inner tube may be in fluid communication with the internal cavity and at least partially disposed within the outer tube such that a venting channel is defined between at least a portion of the inner tube and at least a portion of the outer tube.

A method of collecting bone and/or cellular material during a bone harvesting procedure is also provided herein. The method includes the steps of (a) operating a reaming, milling, or drilling tool so that the tool reams, mills, or drills into a canal of a bone to generate bone and/or cellular material, (b) inserting a bone harvesting tool into the bone canal, the bone harvesting tool comprising an inner tube at least partially disposed within an outer tube such that a ventilation channel is formed between the inner and outer tubes, (c) generating negative pressure within an internal cavity of a bone harvesting tool, the negative pressure causing the bone and/or cellular material to flow from the patient through the inner tube and into the internal cavity of the bone harvesting tool, and collecting the bone and/or cellular material in a storage container fluidly connected to the internal cavity of the bone harvesting tool.

As used herein, "axial" means along or parallel to the longitudinal axis of the bone harvesting device and "radial" means in the perpendicular direction thereto. "Interior" or "inner" means radially inward, either toward or facing the longitudinal axis, and "exterior" or "outer" means radially outward, or away from the longitudinal axis. The terms "proximal" and "distal" refer, respectively, to the end of the device nearest the surgeon or other user operating the device, and the opposite end of the device furthest from the user operating the device.

Bone harvesting device <NUM>, as shown in <FIG>, includes a body <NUM>, an aspiration assembly <NUM> for aspirating bone and/or cellular material from a patient, and a collection storage container <NUM> for collecting the aspirated material. The phrase bone and/or cellular material refers to material that is extractable from bone, which may optionally then be processed and/or separated to produce another material. For instance, bone and/or cellular material may include cancellous bone, cortical bone (in the form of chips or morselized bone), bone marrow, or stem cells produced from any of the foregoing materials. Such materials are frequently found, for example, in the iliac crest, or the medullary canal of a long bone, as well as the bone surrounding the medullary canal. Bone harvesting device <NUM> may be formed entirely, or in part, from a transparent medical grade glass or plastic, thereby permitting an operator using the device to observe the collection of bone and/or cellular material during a harvesting procedure.

Main body <NUM> includes a first connector, for example, a threaded bore <NUM>, for removably securing aspiration assembly <NUM> to the body, and a second connector, for example, a threaded, lid-shaped platform <NUM> for removably securing storage container <NUM> to the body. It will be appreciated, however, that the first and second connectors need not include threads. Instead, aspiration assembly <NUM> and storage container <NUM> may alternatively be coupled to the main body <NUM> via an interference or snap-fit connection, or any other connector known in the art. Main body <NUM> also defines a suction port <NUM>, for example, in lid-shaped platform <NUM> that is configured to be coupled to a suction source S such as a standard operating room suction source (OR suction). Suction port <NUM> may include a filter to prevent bone and/or cellular material from being drawn from storage container <NUM> into a suction tube connected suction source S.

With specific reference to <FIG>, platform <NUM> has an aperture <NUM> that allows harvested bone and/or cellular material to flow from aspiration assembly <NUM> and into storage container <NUM> during a harvesting procedure. As shown, main body <NUM> may also include an ergonomically shaped handle <NUM> to aid a surgeon in positioning the bone harvesting device during operation.

Referring to <FIG>, main body <NUM> defines an internal cavity <NUM> that is in fluid communication with aspiration assembly <NUM> and suction source S. Thus, when OR suction is applied, a negative pressure is produced within internal cavity <NUM>. This negative pressure draws bone and/or cellular material through aspiration assembly <NUM>, into the internal cavity, through the aperture <NUM> and into storage container <NUM>.

Aspiration assembly <NUM>, as shown in <FIG>, includes a generally hollow adapter housing <NUM>, an outer tube <NUM> and an inner tube <NUM>. Outer tube <NUM> and inner tube <NUM> are formed of a resilient and flexible material that allows the tubes to bend, with respect to the main body <NUM> and with respect to one another, as the aspiration assembly navigates through the medullary canal of a long bone. Aspiration assembly <NUM> defines a length between a proximal end <NUM> and a distal end <NUM> of the assembly. Bone harvesting device <NUM> may include a single aspiration assembly <NUM> measuring approximately <NUM> in length, or a plurality of interchangeable aspiration assemblies having various lengths for harvesting bone of different length.

The proximal end <NUM> of aspiration assembly <NUM> includes threads <NUM> for threading adapter <NUM> within the bore <NUM> of main body <NUM>. Adapter <NUM> need not include threads, however, as aspiration assembly <NUM> may instead be removably coupled to main body <NUM> by an interference or snap fit connection, or any other connector known in the art. Adaptor <NUM> may also include a flange <NUM>, or similar protrusion having an ergonomic grip to aid a user in coupling and/or decoupling the aspiration assembly <NUM> to the main body <NUM>.

With specific reference to <FIG>, adaptor <NUM> has one or more annular grooves <NUM> within its exterior surface. A gasket <NUM>, such as an O-ring, is provided within each groove <NUM> to seal the space between the adaptor <NUM> and the bore <NUM> of the main body at each location. Adapter <NUM> also includes first and second inwardly projecting ledges <NUM>, <NUM>. The first ledge <NUM> is provided adjacent the proximal end of adapter <NUM>, while the second ledge <NUM> is positioned between the first ledge and the flange <NUM>. First ledge <NUM> protrudes further into the interior space of the adapter <NUM> than the second ledge <NUM>.

Outer tube <NUM> extends along a longitudinal axis L from a proximal end <NUM> to a distal end <NUM> and includes an exterior surface <NUM> and an interior surface <NUM>. The exterior surface <NUM> of outer tube <NUM> engages the interior surface of adapter <NUM>, while the proximal end <NUM> of the outer tube is bonded, welded, glued or otherwise sealed to a distal facing surface of the second ledge <NUM>. The distal end <NUM> of outer tube <NUM> is preferably rounded, as shown in <FIG>, to reduce trauma as aspiration assembly <NUM> is operated within the medullary canal of bone.

Inner tube <NUM>, which is positioned at least partially within outer tube <NUM>, extends along a longitudinal axis L' from a proximal end <NUM> to a distal end <NUM> and includes an exterior surface <NUM> and an interior surface <NUM>. Inner tube <NUM> is bonded, welded, glued or otherwise sealed to an inwardly facing surface of the first ledge <NUM>, thereby forming a venting channel <NUM> between the inner and outer tubes.

Adapter <NUM> further defines a vent <NUM> axially located between the first and second ledges <NUM>, <NUM>. Vent <NUM> is in fluid communication with ambient air and venting channel <NUM>. As shown in <FIG>, this allows ambient air drawn into vent <NUM> to flow through venting channel <NUM> and into the medullary canal adjacent the distal end of the aspiration assembly, while bone and/or cellular material is concurrently aspirated through the inner tube <NUM> in the opposite direction (e.g., from the distal end of the aspiration assembly toward the main body). The ventilated air provides airflow through the medullary canal during the harvesting process and prevents the medullary canal from becoming negatively pressurized during aspiration and, as a result, reduces the amount of blood loss that occurs during bone and/or cellular aspiration as is further explained hereinafter.

In some embodiments, the distal end <NUM> of inner tube <NUM> may be proximal to the distal end <NUM> of outer tube <NUM>. The vented air is thus drawn around the distal end <NUM> of inner tube <NUM> and into the aspiration channel of the inner tube. This reduces clogging at the distal end of the aspiration assembly and maintains optimal suction or aspiration power. Moreover, because inner tube <NUM> is surrounded by the outer tube <NUM>, the inner is protected from being damaged.

Referring to <FIG>, various exemplary configurations of the aspiration assembly are described. <FIG> illustrates a preferred aspiration assembly 200A, in which inner tube 206a is coaxially positioned within outer tube 204a. Venting channel 240a is thus formed around the entire exterior surface of inner tube 206a.

<FIG> shows aspiration assembly 200b, in which the longitudinal axis L'B of inner tube 206b is offset with respect to the longitudinal axis LB of outer tube 204b, and the exterior surface 236b of the inner tube is spaced from the interior surface 230b of the outer tube. Venting channel 240b entirely surrounds inner tube 206b.

<FIG> illustrates a third configuration, aspiration assembly 200c, in which the longitudinal axis L'c of inner tube 206c is offset with respect to the longitudinal axis Lc of outer tube 204c. In this configuration, however, a portion of the exterior surface 236c of inner tube 206c engages a portion of the interior surface 230c of outer tube 204c. Venting channel 240c is thus only formed around a portion of inner tube 206c (i.e., the portion of the exterior surface of the inner tube that is not engaged with the outer tube).

<FIG> illustrates aspiration assembly 200d, which is similar to aspiration assembly 200c, in that the longitudinal axis L'D of inner tube 206d is offset with respect to the longitudinal axis LD of outer tube 204d, and in that a portion of the exterior surface 236d of the inner tube is engaged with a portion of the interior surface 230d of the outer tube such that venting channel 240d is formed only around a portion of the inner tube. In this configuration, however, the cross-section of outer tube 204d is elliptical. It will be appreciated that the inner tube or the outer tube, or both the inner tube and the outer tube, of any of the configurations shown in <FIG>, may have a cross-section forming an ellipse, a rectangle, a hexagon or any other shape.

Aspiration assembly 200e, as shown in <FIG>, includes first and second inner tubes 206e<NUM>, 206e<NUM>. The longitudinal axis L'E1 of first inner tube 206e<NUM> and the longitudinal axis L'E2 of second inner tube 206e<NUM> are offset with respect to the longitudinal axis LE of outer tube 204e. A portion of the exterior surface 236e<NUM> of first inner tube 206e<NUM> and a portion of the exterior surface 236e<NUM> of second inner tube 206e<NUM> are engaged with portions of the interior surface 230e of outer tube 204e. Venting channel 240e is thus formed only around the portions of inner tubes 206e<NUM>, 206e<NUM> that are not engaged with outer tube 204e. It will be understood, however, that one or both of inner tubes 206e<NUM>, 206e<NUM> may instead be spaced from the interior surface 230e of outer tube 204e such that venting channel 240e is formed entirely around the inner tube, or the inner tubes, spaced from the interior surface of the outer tube.

<FIG> illustrates aspiration assembly 200f. In this configuration, first inner tube 206f<NUM> is coaxially positioned within outer tube 204f and second inner tube 206f<NUM> is coaxially positioned within the first inner tube. Venting channel 240f is thus positioned between the first and second inner tubes 206f<NUM>, 206f<NUM>.

It will be appreciated that aspiration assembly <NUM> may be constructed as described in any one of the embodiments shown in <FIG> or as a combination of the same. Regardless of the specific construction, it is generally desirable that the aspiration channel (e.g., the opening of the inner tube(s)) has a cross-sectional area of at least <NUM><NUM>. Moreover, to ensure that sufficient air is vented into the medullary canal, it is desirable that the ratio of the surface area of the cross-section of the venting channel relative to the surface area of the cross-section of the aspiration channel be between <NUM> and <NUM>. It will be understood that <FIG> illustrate the inner and outer tubes in their unbent, or not flexed, condition. Any bending or flexing of inner tube <NUM>, relative to outer tube <NUM>, will change the location of the aspiration channel and, in turn, venting channel <NUM> relative to the outer tube, but will not modify the cross-sectional area of the aspiration channel or the cross sectional area of the venting channel.

Turning now to <FIG>, storage container <NUM> includes a stand <NUM> and a collection bowl <NUM>. Storage container <NUM> is preferably formed as an integral component of a plastic material, for example, through an injection molding process. Alternatively, stand <NUM> and collection bowl <NUM> may be coupled together after the components are separately manufactured.

Stand <NUM> may include a cylindrical sidewall <NUM> that extends from an annular base <NUM> to a top end <NUM> and that defines a diameter and height. Base <NUM> is planar and, thus, configured to rest on a flat surface, for example, an operating table. In a preferred embodiment, the diameter of stand <NUM> is at least <NUM> times greater than the height to save stance on soft and irregular surfaces. Base <NUM> may include a flange <NUM> for added stability.

Top end <NUM> preferably includes an inwardly extending lip <NUM> for receiving a gasket (not shown) to seal the connection between container <NUM> and main body <NUM>. Sidewall <NUM> may include a plurality of ergonomically shaped grips <NUM> to aid a user in connecting the storage container <NUM> to the main body <NUM> and for removing the container from the body. Grips <NUM> are also thickened areas of material that strengthen sidewall <NUM>.

Collection bowl <NUM> includes a sidewall <NUM> that is connected to lip <NUM> such that a first portion <NUM> of the collection bowl sits within the sidewall <NUM> of stand <NUM> and a second portion <NUM> of the collection bowl extends above the top end <NUM> of the stand.

As shown, the second portion <NUM> includes threads <NUM>, for example, steep or bayonet threads for coupling the storage container <NUM> to the lid-shaped platform <NUM> of the main body. Collections bowl <NUM> may alternatively include any connector capable of removably coupling the storage container and the main body.

The inner surface of sidewall <NUM> is preferably smooth and hemispherical in shape. In contrast to an ordinary container having a flat base and a sidewall, the interior surface of hemispherical collection bowl <NUM> is devoid of edges. Because bone and/or cellular material is harvested in relatively small and finite quantities, and through an invasive surgical procedure, it is desirable to preserve all of the material that is harvested from the patient for subsequently processing. The hemispherical shape of the collection bowl <NUM> assists in this effort as it allows a user to easily remove all of the highly viscous bone and/or cellular material without requiring that the user attempt to scrape material from the edges or the corners of the container before inevitably leaving traces of the material behind. Thus, the hemispherical collection bowl <NUM> saves the user both time and hassle and maximizes the bone and/or cellular material that is eventually processed. To aid the user in removing bone and/or cellular material from collection bowl <NUM>, the open end of sidewall <NUM> is preferably at least <NUM> in diameter, thereby allowing the user to easily fit his or her hand into the collection bowl and to scoop out the material, for example, using his or her fingers.

In some embodiments, an indicator scale <NUM> may be molded to, or imprinted on, storage container <NUM> such that the user can easily determine the volume of bone and/or cellular material that is present within collection bowl <NUM>.

Bone harvesting device <NUM> may be used to harvest bone and/or cellular material in a harvesting method as provided herein. The method generally includes extracting bone and/or cellular material from a patient and then sending it to a storage, separation and processing facility (e.g., a "biobank") for use in a later surgical procedure involving that patient, or a different patient.

In many instances, a patient is scheduled to undergo a surgical procedure that necessitates resection of bone and/or reaming of a medullary canal of bone, but in which harvesting bone and/or cellular material is not the primary objective of the surgical procedure. For example, intramedullary nailing (IM nail) procedures, hip replacements, and knee revisions, each require a substantial amount of resection and/or reaming of bone, and therefore, generate bone and/or cellular material as a byproduct of the surgery.

During an IM nail procedure, for example, a surgeon seeking to remedy a fracture in the tibia typically first makes an incision in the patient's skin adjacent the knee. A K-wire is then introduced through the patient's skin and into an entry point on the patient's tibial plateau. In a reamed technique, the surgeon then uses the K-wire to guide a reamer through the entry point and into the medullary canal of the long bone. With the K-wire extending into the long bone and past the fracture site (e.g., so that the fracture can be properly reduced), one or more reamers are then used to bore through cortical and cancellous bone, as well as bone marrow of the patient. Because harvesting bone and/or cellular material is not the primary objective of the IM nail procedure, and extraction of these materials can often result in sever blood loss and other complication, bone and/or cellular material is generally only extracted from the medullary canal of the tibia to the extent necessary to make room for the IM implant. Any cortical bone, cancellous bone and bone marrow material that is extracted during the reaming procedure is often discarded. Using harvesting device <NUM>, however, bone and/or cellular materials can be safely extracted from the patient for subsequent processing and reuse without placing the patient at risk.

Referring to <FIG> and <FIG>, a method of extracting bone and/or cellular material from a patient is described, using an IM nail procedure remedying a patient's fractured femur as an illustrative example. It will be understood, however, that bone harvesting device <NUM> significantly reduces surgical complications when used to aspirate bone and/or cellular material within a medullary cavity and, thus, may likewise be used to harvest material from within the medullary canal of the tibia or any other bone from which bone and/or cellular material may be harvested.

In reducing a fractured femur, a surgeon may first approach the fracture by making an incision in the patient's skin adjacent the hip. The surgeon may then resect the greater trochanter, thereby creating an opening to the medullary canal of the femur. Resection of the greater trochanter generates loose cortical and cancellous bone, which may optionally be collected, either by hand or using bone harvesting device <NUM>. To collect the loose cortical and cancellous bone using harvesting device <NUM>, a user turns on the OR suction S, which generates a negative pressure in the internal cavity <NUM> of main body <NUM>. Using handle <NUM>, the user may position the distal end <NUM> of the aspiration assembly adjacent the resected bone, causing the loose cortical and cancellous bone to be drawn through the aspiration channel of inner tube <NUM>, into the internal cavity, through aperture <NUM> in lid <NUM> and into storage container <NUM>. After the loose cortical and cancellous bone has been collected, the user may turn off the OR suction S.

A K-wire may then be introduced through the patient's skin and into the medullary canal of the femur. The surgeon may then use the K-wire to guide one or more reaming, milling or drilling tools through an entry point and into the medullary canal of the femur. With the K-wire extending within the medullary canal and past the fracture site, the tool is used to bore through cortical and cancellous bone, as well as bone marrow of the patient, generating bone and/or cellular material in the medullary canal. After the surgeon is satisfied that a bore of sufficient size has been created to receive the IM implant, the tool may be removed from the patient. The surgeon may then optionally collect the residual bone and/or cellular material that adhered to the tool(s) during the reaming, milling or drilling of the medullary canal.

Before implanting the IM nail, the surgeon may utilize harvesting device <NUM> to safely collect bone and/or cellular material from the medullary canal of the femur. In doing so, the OR suction S is again activated. With a negative pressure generated in the internal cavity <NUM> of main body <NUM>, the surgeon may position the distal end <NUM> of the aspiration assembly into the medullary canal of the femur such that the main body is positioned outside the patient.

Referring to <FIG>, schematically illustrating only inner tube <NUM> for clarity, ambient air enters vent <NUM> (<FIG>) and flows through venting channel <NUM> (<FIG>) and into the medullary canal. At the same time, the negative pressure generated within the internal cavity <NUM> of main body <NUM> draws bone and/or cellular material through the aspiration channel of inner tube <NUM> and into storage container <NUM>. Because air is continually vented within the medullary canal adjacent the distal end <NUM> of aspiration assembly <NUM>, the medullary canal does not become negatively pressurized during aspiration of the bone and/or cellular material. Moreover, in the embodiment in which the distal end <NUM> of inner tube <NUM> is provided proximal to the distal end <NUM> of outer tube <NUM>, the vented air is drawn around the distal end of the inner tube and into the aspiration channel thereof. The curling of the air adjacent the distal end <NUM> of aspiration assembly <NUM> guides bone and/or cellular material into the aspiration channel of inner tube <NUM> such that clogging is reduced and optimal suction or aspiration power is maintained.

In contrast, as is shown in <FIG>, illustrating a known bone harvesting device that does not include the described venting features, as bone and/or cellular material is aspirated though the aspiration assembly, the medullary canal becomes negatively pressurized. The negative pressure results in the aspiration of blood and can result in sever blood loss. Additionally, as the medullary canal drops in pressure, the aspiration power of the assembly is reduced, resulting in decreased aspiration efficiency and often clogging of the assembly.

Referring back to <FIG>, the user may optionally combine the bone and/or cellular materials into a cumulate harvest. In order to do so, the user first uncouples storage container <NUM> from main body <NUM>, sticks his or her hand into collection bowl <NUM> and scoops out all of the bone and/or cellular material. The bone and/or cellular material may then be combined with the residual bone and/or cellular material collected from the reaming, milling or drilling tools and/or the loose bone and/or cellular material generated during the bone resection step.

After the bone and/or cellular material has been harvested, the surgeon may implant the IM nail and finish the IM nail procedure.

The bone and/or cellular material may then be sent to a biobank as separate collections, or as a cumulate harvest, for subsequent processing and use in a later surgical procedure involving that patient, or a different patient.

Claim 1:
A bone harvesting device (<NUM>) for extraction of bone and/or cellular material from a patient during a surgical procedure, the device comprising:
a main body (<NUM>) defining an internal cavity (<NUM>), the main body including a suction port (<NUM>) adapted to be coupled to a suction source (S); and
an aspiration assembly (<NUM>) comprising:
an outer tube (<NUM>) having an interior surface (<NUM>), an exterior surface (<NUM>), a proximal end (<NUM>) and a distal end (<NUM>), the proximal end (<NUM>) of the outer tube (<NUM>) being coupleable to the body (<NUM>); and
an inner tube (<NUM>) having an interior surface (<NUM>), an exterior surface (<NUM>), a proximal end (<NUM>) and a distal end (<NUM>), the inner tube (<NUM>) being in fluid communication with the internal cavity (<NUM>) and at least partially disposed within the outer tube (<NUM>),
such that a venting channel (<NUM>) is defined between at least a portion of the exterior surface (<NUM>) of the inner tube (<NUM>) and at least a portion of the interior surface (<NUM>) of the outer tube (<NUM>) such that ambient air flows through the venting channel (<NUM>) in a proximal-distal direction and curls around the distal end (<NUM>) of the inner tube (<NUM>) while the bone and/or cellular material is aspirated through the inner tube (<NUM>) in a distal-proximal direction.