U.S. patent application number 11/409816 was filed with the patent office on 2007-11-22 for autologous bone harvest during osteotomy and bone drilling procedures.
Invention is credited to Mark Michels, James D. Ralph, Thomas N. Troxell.
Application Number | 20070270771 11/409816 |
Document ID | / |
Family ID | 37192466 |
Filed Date | 2007-11-22 |
United States Patent
Application |
20070270771 |
Kind Code |
A1 |
Ralph; James D. ; et
al. |
November 22, 2007 |
Autologous bone harvest during osteotomy and bone drilling
procedures
Abstract
An apparatus and method for collecting particulate bone from the
operating site during an osteotomy or bone drilling procedure so
that it can be used subsequently to augment the bone fusion
process. A bone cutting or drilling tool is provided with a module
for collecting particulate bone simultaneously with cutting or
drilling the bone. The collected particulate bone is transferred
continuously to a sterile containment module and maintained under
sterile conditions until it is prepared for re-use in the
patient.
Inventors: |
Ralph; James D.; (Bethlehem,
PA) ; Troxell; Thomas N.; (Pottstown, PA) ;
Michels; Mark; (Glen Mills, PA) |
Correspondence
Address: |
NORRIS MCLAUGHLIN & MARCUS, P.A.
P O BOX 1018
SOMERVILLE
NJ
08876
US
|
Family ID: |
37192466 |
Appl. No.: |
11/409816 |
Filed: |
April 24, 2006 |
Current U.S.
Class: |
604/317 |
Current CPC
Class: |
Y10S 606/903 20130101;
A61B 17/1635 20130101; A61B 2217/005 20130101; A61B 17/1739
20130101; A61F 2/4644 20130101; A61B 17/17 20130101; A61B 2217/007
20130101; A61B 17/1695 20130101; A61B 17/1728 20130101; A61B
2017/00969 20130101; A61F 2002/4645 20130101 |
Class at
Publication: |
604/317 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1. Apparatus for collecting particulate bone for use in combination
with a bone cutting or drilling tool during an osteotomy or bone
drilling procedure, the bone cutting or drilling tool having a
distal end with a bone cutting or drilling element, comprising a
collection module adaptable to the distal end, the module
comprising an open distal end and a suction port opening into the
distal end.
2. The apparatus of claim 1 further comprising an irrigation port
opening into the distal end.
3. The apparatus of claim 1 wherein the collection module is
flexible.
4. The apparatus of claim 1 wherein the bone cutting or drilling
element extends beyond the distal end of said module.
5. The apparatus of claim 1 further comprising a means of
containing the particulate bone.
6. The apparatus of claim 1 wherein the collection module is
disposable.
7. Apparatus for cutting or drilling bone and collecting
particulate bone during an osteotomy or a bone drilling procedure
comprising a bone cutting or drilling tool having a distal end
comprising a bone cutting or drilling element, a collection module
adapted to the distal end, the module comprising a suction port
opening into the open distal end.
8. The apparatus of claim 7 wherein the module further comprises an
irrigation port opening into the distal end.
9. The apparatus of claim 7 wherein the collection module is
flexible.
10. The apparatus of claim 7 wherein the bone cutting or drilling
element extends distally from said module through an open distal
end of said module.
11. The apparatus of claim 7 wherein the bone cutting or drilling
tool further comprises an irrigation port opening into the distal
end.
12. Apparatus for cutting or drilling bone and collecting
particulate bone during an osteotomy or bone drilling procedure
comprising a bone cutting or drilling tool having a distal end
comprising a bone cutting or drilling element and a suction port a
collection module adapted to the distal end, said module being
sealingly engaged with the tool at the proximal end of the module
and having an opening at the distal end of the module wherein the
bone cutting or drilling element can extend distally through the
opening and beyond the distal end of the module, and the suction
port is in suctioning communication with the opening.
13. The apparatus of claim 12 wherein the bone cutting or drilling
tool further comprises an irrigation port opening into the distal
end and the irrigation port is in irrigating communication with the
opening.
14. The apparatus of claim 12 wherein the collection module is
flexible.
15. The apparatus of claim 12 wherein the collection module is
disposable.
16. A method of assembling an apparatus for cutting or drilling
bone and collecting particulate bone during an osteotomy procedure
or bone drilling comprising affixing to the distal end of a bone
cutting or drilling tool, the distal end comprising a bone cutting
or drilling element, a collection module having an open distal end,
the bone cutting element capable of extending distally through said
open distal end, the module or the tool comprising a suction port
in suctioning communication with said open distal end.
17. The method of claim 16 wherein the module or the tool further
comprise an irrigation port opening into said open distal end and
in irrigating communication with said open distal end.
18. A method of collecting particulate bone created at the
operating site during an osteotomy or bone drilling procedure
comprising cutting or drilling the bone with a bone cutting or
drilling tool having a distal end, the distal end comprising a bone
cutting or drilling element and a collection module, the bone
cutting element extending distally from an open distal end of the
collection module during cutting, the module or tool comprising a
suction port opening into the open distal end, and suctioning the
particulate bone from the operating site into the collection
module.
19. The method of claim 18, wherein the module or tool further
comprises an irrigation system having an irrigation port opening
into the distal end, further comprising irrigating the operating
site during the osteotomy or bone drilling procedure.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention has to do with apparatus and methods
for performing osteotomies and drilling holes in bones. More
specifically, the invention relates to apparatus and methods for
harvesting bone from the operating site during the osteotomy or
bone drilling procedure so that it can be used to augment the bone
fusion process.
[0003] 2. The Related Art
[0004] Osteotomies are routinely performed for surgical access or
to divide (and reposition) a bone for the correction of a skeletal
deformity. Holes may be drilled in bones for various reasons to
accommodate screws, pins and various other implantable devices and
materials or to take a bone sample for analysis.
[0005] One of the more common examples of an osteotomy for surgical
access is a craniotomy. In this procedure, the surgeon removes a
significant portion of the patient's skull (termed a craniotomy
flap, a cranial flap, a skull flap or bone flap) for access to the
brain. The removed section of the skull is set aside in a sterile
field and at the end of surgery, it is returned to its original
position and affixed to the native skull, typically with plates and
screws. The intent of the surgeon is to restore the patient's skull
to its original contour and to provide physical protection for the
brain. The ideal outcome would be complete fusion of the craniotomy
flap to the native skull, leaving no long term bony deficit or
weakness. In addition, many surgeons would prefer there to be
minimal foreign bodies remaining and no imaging artifacts
postoperatively. Unfortunately this is difficult to accomplish with
the current surgical techniques.
[0006] The surgical instrument used to cut the craniotomy (a
craniotome) utilizes a rotating cutter approximately 2 mm in
diameter. The bone that is removed by this instrument is lost
during surgery and as a result, when the cranial flap is returned
to its original position, there is a gap around the entire
periphery which corresponds to the diameter of the cutter. This gap
creates a number of problems. The most obvious deficiency is that
bone-to-bone contact, essential for achieving bony fusion, is
impossible around the periphery of the cranial flap. This
continuous gap (or kert) creates a surgical "dead space" which is
never desirable, it also allows soft tissue (the scalp and dura) to
intrude into this space and inhibit bony healing. The step-off
between the skull and cranial flap also may result in a cosmetic
deformity for the patient. To combat these problems, surgeons use
one or more strategies which have their own shortcomings. For
example, the surgeon may choose to bias the cranial flap toward one
side of the craniotomy. This produces bone-to-bone contact in a
local area but increases the gap elsewhere around the
periphery.
[0007] The surgeon may also elect to fill the gap between the skull
and skull flap with a material which will encourage bony fusion.
These fill materials can be autologous, allograft, or artificial.
Autologous bone grafts are harvested directly from the patient and
are the "gold standard," since they are inherently biocompatible,
osteoconductive, osteoinductive, and osteogenic. Harvesting
autologous bone is currently carried out by taking bone from a part
of the patient's body other than the surgical site. This results in
additional surgical time and the additional (surgical) harvest has
its own attendant risk of complications such as donor site pain and
morbidity. Allografts, derived from donor (cadaver) tissues, are
only osteoconductive, and they involve considerable cost, pose the
risk of disease transmission and are objectionable to certain
religious groups. Artificial materials such as alloplastic bone
cement are another alternative. These bone cements are almost
always used in conjunction with plates and screws. The drawbacks to
this approach include substantial additional cost, risk of
infection and no certainty that the bone cement will ever remodel
into actual bone.
[0008] While this problem is illustrated with a craniotomy example,
it occurs whenever an osteotomy is created strictly for surgical
access and the bones must be returned to their original positions
in order to prevent a postoperative deformity or a functional
problem. In the skull alone, this problem exists in skull base
surgery, craniofacial tumor surgery and mandibular osteotomies for
oncologic resection. At the conclusion of all these procedures, the
surgical goal is to restore the original bony anatomy. This
precludes achieving bone-to-bone contact of the severed ends since
they must remain separated by the width of the blade (or cutter)
used for the osteotomy.
[0009] Perforations (or holes) are routinely created in bones for
surgical access and other reasons. These perforations may be
performed for biopsy purposes, to create access for minimally
invasive surgery or as the prelude to an osteotomy. An example of
the latter is the burr hole that is initially created in the skull
which allows the craniotome to be inserted for completion of the
craniotomy. In these cases, it is desirable to close the
perforation, preferably in a manner which restores the bone to its
original condition. Additionally, holes are routinely drilled into
bone as a step in preparation for orthopaedic screw or pin
insertion. Most of these cases would also benefit from the
availability of autologous bone graft.
[0010] When osteotomies are used to divide a bone so that it may be
repositioned to correct a surgical deformity, a different problem
exists. In many cases, bone graft material is needed to fill the
gaps created as the bones are repositioned and severed bony ends
move relative to each other. This is obviously the case where a gap
is intentionally created, such as an osteotomy to elevate a
collapsed tibial plateau. It also may occur when the intent of the
osteotomy is to decrease the bone volume. In these surgeries it is
not uncommon for the contours of the bony ends to be slightly
mismatched and in these cases the surgeon may elect to augment the
fusion with additional bone graft material. As previously
discussed, allograft bone, autogenous bone or alloplastic materials
may all be used in such situations, each with their related
problems.
[0011] In all these procedures where an osteotomy (or perforation)
is necessary, a common problem exists: bone is removed by the
osteotomy or drilling instrument and at the conclusion of surgery,
additional bone is required to complete the reconstruction.
[0012] The current surgical practice is to manually irrigate the
bone as it is cut and also to manually suction off the resulting
solids and liquids into the operating room's non-sterile vacuum
system. These activities are performed concurrently by other
operating room personnel while the surgeon operates the osteotomy
instrument. Some of the shortcomings of these practices are
detailed in the following text which is excerpted from the USC
Neurosurgery website.
(http://uscneurosurgery.com/infonet/ecrani/instruments.htm).
Irrigation
[0013] With even optimal illumination and magnification and
organization of his field, the surgeon is still incapacitated by
obscuring blood, cloudy irrigation fluid, or other debris.
Efficient intracranial surgery requires keeping the operative field
clear of physical and visual obstacles by diligent irrigation,
attentive aspiration, and meticulous hemostasis.
[0014] Irrigation and aspiration are complimentary aspects of
surgical field maintenance. The irrigating-aspirating assistant
must concentrate on following the movements of the surgeon's hands
visually and with irrigant and suction. Areas of surgical interest
are most safely addressed at the time of maximal cleanliness;
immediately after they have been washed clean and aspirated
dry.
[0015] Irrigant should be squirted onto the field under enough
pressure to displace blood, but if the bulb is squeezed too hard
and fluid issues under too much pressure, fluid from the bulb will
be reflected back against the stream because it cannot dissipate
fast enough, with the consequence that a splashing of mixed
blood-irrigant fluid ends up in the surgeon's face and widely
scattered across the field. Better control of the stream from the
irrigation fluid bulb is achieved by manipulating it with the
dominant hand.
[0016] The primarily aqueous solution used for surgical irrigation
not only dilutes the blood but pushes it ahead of the irrigant
stream. This washing force is greatest at the tip of a irrigation
bulb where the irrigant fluid pressure is maximal.
Suction
[0017] Blood accumulates with irrigation fluid in dependent
portions of the field as it escapes and is washed from lacerated
vessels. The bloody fluid then interferes with the working of the
electrocautery devices used to stop further bleeding from the
openings in the vessels. To this is added the problem of blood's
opacity, so that even in small quantities as even a thin layer, it
obscures the surgical field.
[0018] Suction is a maintenance activity, keeping the operative
field clear of debris, blood, or smoke that can obstruct
visualization. Whenever possible the suction attachment should be
held in the non-dominant hand.
[0019] Surgical field suction instrumentation attaches to the same
suction canisters which provide suction for anesthesia. Distally
non-sterile, proximally sterile tubing connects the suction device
to the distal end of the metal suction handle and tip. The proximal
end of the metal sucker connects to the suction tubing.
[0020] The importance and difficulty of performing simultaneous
irrigation and suction in concert with the surgeon's movements are
detailed above. Later in the text they discuss the importance of
irrigation when cutting the bone:
[0021] Bone is perforated and/or cut in the course of any
intracranial trauma surgery. Irrigation accomplishes two purposes
in the setting of drilling bone. First, it cools down the bone.
This is important in terms of the mechanics of bone cutting. The
bits cut more effectively through cooler bone and in the absence of
bone dust that can clog its rotations.
[0022] These comments are directed toward neurosurgical
craniotomies but the same principles apply to all osteotomies and
perforations. Proper irrigation not only improves the efficiency of
the cutting instrument, it also prevents thermal necrosis of the
bone which can later retard the healing process. This principle
takes on even greater importance when one intends to collect the
bone particles generated during the cutting process and reuse them
in surgery. Irrigation has traditionally been conducted using a
liquid. But according to the present invention we can irrigate with
a liquid or compressed gas source or a combination of liquid and a
compressed gas source. The compressed gas can be chilled if
required and also can be intermixed with a fluid (e.g.,
saline).
[0023] Up until now, a reliable and essentially free source of
autogenous bone has been overlooked by the surgical community.
Manufacturers of surgical cutting instruments have incorporated
irrigation on some instruments but none have ever proposed taking
the concept one step further--collecting the bone particulate in a
sterile fashion for later use in the bony reconstructive phase of
the surgery.
[0024] We have now developed apparatus and methods for sterilely
collecting and containing the particulate bone created during
osteotomy and bone drilling procedures. The apparatus and methods
also enable more controlled irrigation of the bone as it is cut or
drilled and a reduction in the amount of patient bone that is
scattered or aerosolized during surgery.
[0025] The terms particulate bone, bone particulate and bone
particles are used interchangeably in this patent and all are
intended to have the same meaning.
SUMMARY OF THE INVENTION
[0026] A collection module is provided on the cutting end, also
referred to herein as the distal end, of a bone cutting tool to
prevent the scatter and loss of particulate bone created at the
operating site during an osteotomy or bone drilling procedure. The
collection module suctions off the bone particulate as well as
irrigant, blood and other body fluids and reduces contamination of
the surgical field from the cutting operation. The module can be
partially or completely disposable.
[0027] The collection module contains a suction port which
evacuates the particulate bone from the cutting operation. A
sterile containment module is provided downstream for collecting
the particulate bone and separating it from irrigant and body
fluids suctioned off from the surgical field.
[0028] An irrigation system is incorporated in some cutting tools
and when it is not, it can be incorporated in the collection module
to provide a reliable and effective source of irrigation to the
cutting area. The irrigant prevents thermal necrosis, prevents the
formation of bone dust, improves cutting efficiency and improves
visibility within the surgical field. As previously disclosed, the
irrigation system in our invention can disperse fluids, gasses or a
combination of the two.
[0029] The sterile bone particles which are harvested according to
the invention are used to augment the reconstructive portion of the
surgery. The particulate bone can be used "as is" or mixed with any
number of readily available additives such as, but not limited to:
[0030] a. Patient's blood; [0031] b. Patient's platelet rich plasma
(PRP); [0032] c. Bone morphogenic proteins; [0033] d. Other bone
growth factors; and [0034] e. Antibiotics.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] The drawing figures are provided for purposes of
illustrating the elements of the invention and are not intended to
be drawn to scale.
[0036] FIG. 1 is an expanded perspective view of a bone cutting
tool (a craniotome) of the invention which has been provided with
integral irrigation and suction systems. A collection module of the
invention is illustrated to the left before attachment to the tool.
The craniotome is attached to a handpiece which in turn is attached
to a pneumatic line or an electric power source.
[0037] FIG. 2 is a perspective view of the craniotome of FIG. 1
with the collection module and the pneumatic line attached.
[0038] FIG. 3 is an elevation view of the craniotome of FIG. 2.
[0039] FIG. 3A is a view of the left end of FIG. 3.
[0040] FIG. 4 is a section view of FIG. 3A taken at section line 44
of FIG. 3A and illustrating a portion of the suction system.
[0041] FIG. 4A is a section of FIG. 3A taken at section line 3-3 of
FIG. 3A and illustrating a portion of the irrigation system.
[0042] FIG. 5 is an elevation view of a collection module of the
invention.
[0043] FIG. 6 is a distal end view of the collection module of FIG.
5.
[0044] FIG. 7 is a section view of the collection module of FIGS. 5
and 6.
[0045] FIG. 8 is an expanded elevation view of a standard prior art
craniotome and a collection module of the invention. This
embodiment of a collection module is for use with standard
craniotomes and is illustrated to the left before attachment to the
tool.
[0046] FIG. 9 is an elevation view of the craniotome of FIG. 8 with
the collection module and the pneumatic line attached.
[0047] FIG. 9A is a view of the left end of FIG. 9.
[0048] FIG. 10 is a section view of FIG. 9A taken at section line
10-10 of FIG. 9.
[0049] FIG. 11 is an elevation view of the collection module of
FIGS. 8-10.
[0050] FIG. 12 is a distal end view of FIG. 11.
[0051] FIG. 13 is a section view of the collection module of FIGS.
11 and 12 taken at section line 13-13 of FIG. 12.
[0052] FIG. 14 is an illustration of an apparatus of the invention
in operation during a cranial osteotomy.
[0053] FIG. 15 is a perspective view of a drill guide of the
invention which can suction and collect bone particulate during a
bone drilling procedure.
[0054] FIG. 16 is a bottom view of FIG. 15.
[0055] FIGS. 17 and 18 are partial section views of FIG. 16. FIG.
17 is taken at section line 17-17 of FIG. 16 and FIG. 18 is taken
at section line 18-18 of FIG. 16.
[0056] FIG. 19 is a perspective view of the guide of FIG. 15
illustrating the relationship of the guide to a drill and a bone
plate.
[0057] FIG. 20 is a partial section of FIG. 19 taken at section
line 20-20 of FIG. 19.
[0058] FIG. 21 is a perspective view of another embodiment of a
bone particulate collection system for use with a drill.
[0059] FIG. 22 is a distal end view of FIG. 21.
[0060] FIG. 23 is a section view of FIG. 22 taken at section line
23-23 of FIG. 22.
[0061] FIG. 24 is an elevation view of a transparent embodiment of
the FIG. 21 collection module affixed to a drill.
[0062] FIG. 25 is an enlarged section view of a portion of FIG.
24.
[0063] FIG. 26 illustrates a sterile containment module of the
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0064] FIG. 1 is an expanded perspective view of a bone cutting
tool of the invention having integral irrigation and suction
systems. The tool is a craniotome which is used to cut an opening
in the skull for brain surgery. The craniotome 1 is attached to a
handpiece 2 which in turn is attached to a pneumatic line 3 (see
FIGS. 2-4) or an electric power source. Cutting burr 5 is actuated
by a foot switch (not shown) and the foot plate 6 is used to guide
the tool along the inside of the skull in order to prevent
penetration of the dura. A suction tube 11 is provided with a
barbed fitting 12 and an irrigation tube 13 has a barbed fitting
14. Collection module 10 is illustrated before it is attached to
craniotome 1.
[0065] FIG. 2 is a perspective view of FIG. 1 with the collection
module 10 of the invention attached to the craniotome. A flexible
bellows 15 is shown in this embodiment with a shield 16 and an
elastomeric seal 17 at the distal end. The shield 16 normally will
be comprised of a relatively stiff, clear plastic tube.
[0066] FIG. 3 is an elevation view of FIG. 2 and FIG. 4 is a
section view of FIG. 3.
[0067] FIG. 4 illustrates suction tube 11 which has an open mouth
23 at its distal end around cutting burr 5. FIG. 4A is a different
section view of FIG. 3 which illustrates irrigation tube 13 of the
irrigation system.
[0068] FIG. 5 illustrates the collection module 10 in an elevation
view and FIG. 6 illustrates the distal end of the collection module
10. FIG. 7 is a section view of the collection module 10.
[0069] FIG. 8 illustrates in expanded elevation another embodiment
of the invention. Collection module 110 is made for use with a
standard prior art craniotome 101. FIG. 9 is an elevation view of
craniotome 101 with collection module 110 affixed thereto. The
collection module 110 comprises a suction tube 111 having a barbed
fitting 112, an irrigation tube 113 having a barbed fitting 114, a
flexible bellows 115 and a clear tubular shield 116. An optional
indicator tab 119 is also illustrated. The craniotome has a foot
plate 106 and a cutting burr 105.
[0070] FIG. 10 is a section view of FIG. 9 illustrating the
relationship of the elements of collection module 110 to the
craniotome 101. In particular, the suction tube 111 connects to a
suction channel 121 and the irrigation tube 113 connects to an
irrigation channel 123.
[0071] FIG. 11 is an elevation view of the collection module 110 by
itself. The collection module 110 provides the irrigation and
suction capability needed to carry out the objectives of the
invention when a standard craniotome having no irrigation or
suction capability is employed. (Some commercially available
craniotomes have irrigation capability in which case the embodiment
of FIG. 11 described herein can be made with suction capability but
without irrigation capability as will be apparent to those skilled
in the art.) This embodiment does not employ a seal of the type
illustrated as element 17 in FIGS. 1-7. In FIG. 12, the distal end
of the module is illustrated with an opening 118 for a cutting burr
and foot plate. An irrigation port 133 is also provided. Referring
to the section view FIG. 13, the irrigation port 133 and the
irrigation channel 123 are illustrated as well as the suction
channel 121 and a suction port 131.
[0072] FIG. 14 illustrates the operation of the distal (cutting)
end of the embodiment of the invention illustrated in FIGS. 1-7.
The craniotome 1 has a cutting burr 5 (and burr shaft 5a) and an
integral foot plate 6. Unlike current instruments, however, the
improved craniotome of the invention has many advantageous
features. In this embodiment, the craniotome also incorporates
internal passages for suction and irrigation. Each of these
terminates proximally in a barbed fitting. The collection module 10
comprises an elastomeric bellows 15, a clear tubular shield 16 and
an elastomeric seal 17. The collection module can constitute a
preassembled, sterile, disposable item, although other
configurations are certainly possible.
[0073] The collection module 10 is adapted to the distal end of the
craniotome 1 (as shown in FIGS. 2-4). Module 10 mates with the
outer diameter of the craniotome 1 and is sealingly engaged
therewith. The two are aligned in the correct orientation to set
the slot 18 in the seal 17 in-line with the footplate 6. Optional
indicator tabs 19 (in the direction that the instrument will cut,
arrow 20) can be used to facilitate correct orientation. The
bellows 15 is constructed from an elastomer, allowing it to flex so
that the distal portion of the collection module 10 can follow the
irregularities of the skull 30 without excessive resistance. On the
other end of the bellows is an internal lip seal 22 which prevents
debris from being forced into the radial space between the
craniotome 1 and the bellows 15. It should be noted that the
cutting burr, or the drill bit or saw blade in other tools, may or
may not extend beyond the distal end of the module when the tool is
not in use. This is because the collection module is sufficiently
flexible to allow such burr, bit or blade to extend beyond the
distal end of the module when the tool is in use.
[0074] The shield 16 is a relatively stiff, clear tubular section
that forms the radial wall of the collection module 10. Attached to
the distal end of the shield 16 is the elastomeric seal 17. Ideally
this would be a relatively clear material as well to aid in
visualizing the cut. The seal 17 has an optionally, outwardly domed
flexible end with a slot 18 to better contain and suction the bone
particulate. The domed shape limits the contact area with the bone
to reduce resistance. As the surgeon operates the craniotome, he
applies both sideways force to cut as well as upward force to keep
the tip of the footplate 6 in contact with the underside of the
skull. This allows the footplate to ride between the dura 4 (the
outer covering of the brain 104) and the inner table of the skull
30. Ahead of the cutting burr 5 is solid skull 30 and trailing the
cutting burr is the kerf 31. The rotation of the cutting burr 5 and
its helical flutes help to draw much of the bone particulate 32
upwards into a collection chamber 24 of the collection module. A
funnel shaped depression or mouth 23 at the junction of the suction
tube 11 and the distal face of the craniotome guides these bone
fragments into the suction tube 11 and draws in by vacuum
additional bone particles, irrigant and bodily fluids. The suction
tube 11 is connected to a sterile vacuum tube 40. A barbed fitting
12 is provided for this connection. The sterile vacuum tube 40 is
connected downstream to a containment module 60 as will be
discussed later. (See FIG. 26.) Suction is applied to tube 40 and
the result is that all material aspirated into the collection
module 10 (bone fragments, irrigant, blood, tissue, etc.) is
evacuated in the direction of arrow 41. The irrigation system is
not illustrated because it is behind the suction system in this
drawing. But the irrigation system is illustrated and discussed
above in connection with FIGS. 1, 2 and 4A. Irrigant supply can be
most easily provided from a pressurized IV bag of saline or from a
hand syringe, peristaltic pump, sterile compressed gas source, or
other common means. When the irrigant is a combination of gas and
liquid an additional channel can be provided in either the
craniotome of the invention (see FIGS. 1-4 and 14) or the
collection module, for the purpose of introducing a second
irrigation means. This additional channel could communicate with
the liquid channel to serve as a mixing device as will be apparent
to those having skill in the art based on the disclosures
herein.
[0075] FIG. 15 is a perspective view of a drill guide of the
invention which can suction and collect bone particulate in a
sterile environment during a bone drilling procedure. The guide 201
comprises a handle 202 and a collection module 210. Sterile vacuum
tube 241 connects to suction tube 211 and irrigant supply tube 243
connects to irrigation tube 213 during operation of the guide.
Opening 218 accommodates a drill bit 205 (see FIGS. 19 and 20) and
irrigation and suctioning take place generally through the same
opening. A bottom view of guide 201 is illustrated in FIG. 16.
[0076] FIGS. 17 and 18 are section views of collection module 210
taken through line A-A and line B-B, respectively, of FIG. 16. The
FIG. 17 section illustrates a barbed fitting 212 at the end of
suction tube 211 and the connection of tube 211 with suction
chamber 221. Irrigation channel 223 and irrigation ports 233 are
illustrated. The FIG. 18 section illustrates another part of
suction chamber 221. The FIG. 18 section also illustrates the
barbed fitting 214 at the end of irrigation tube 213 and the
connection of tube 213 with irrigation channel 223.
[0077] A perspective view illustrating the relationship of the
guide with a drill 203, drill bit 205 and a bone plate 206 is
illustrated in FIG. 19. FIG. 20 is a partial section of FIG. 19
illustrating the relationship of drill bit 205 to the suction
chamber 221, irrigation channel 223 and irrigation ports 233.
During drilling, bone particulate is carried upward by the drill
bit 205 and by suction. Suction vacuum tube 241 is connected to
suction tube 211 and the particulate bone is carried by vacuum to a
sterile containment module 60 (see FIG. 26). The operating area is
irrigated by irrigant exiting irrigation ports 233.
[0078] FIG. 21 is a perspective view of another embodiment of a
bone particulate collection system for use with a drill. Collection
module 310 is comprised of an outer telescoping section 301 and an
inner telescoping section 302. A spring 304 is biased between
section 301 and distal end section 303. When drilling, inner
telescoping section 302 telescopes into outer telescoping section
301 and when the drilling is complete spring 304 returns section
302 to its original position (as illustrated). Sterile vacuum tube
341 and irrigant supply tube 343 are also illustrated.
[0079] FIG. 22 is a distal end view of the collection module 310
also illustrating opening 318 which accommodates a drill bit 305
(see FIGS. 24 and 25) and irrigation and suctioning take place
through the same opening.
[0080] FIG. 23 is a section view of collection module 310
illustrating a collection chamber 321 and irrigation duct 323 in
relation to opening 318.
[0081] FIG. 24 is an elevation view of a transparent embodiment of
collection module 310 affixed to drill 303 having a drill bit 305.
An enlarged section view of a portion of FIG. 24 is provided in
FIG. 25. Arrow 320 illustrates the direction of the telescoping
movement of section 302 into section 301 when the drill bit is
drilled into a bone. Spring 304 causes section 302 to return to the
position illustrated when drilling is completed. Sterile vacuum
tube 341 is in suctioning communication with suction chamber 321
and irrigant supply tube 343 is in irrigating communication with
irrigation duct 323. The suctioning and irrigating operations
function in the same manner as the other embodiments of the
invention discussed above.
[0082] FIGS. 1-25 depict just a few possible configurations of a
cutting or drilling and collection apparatus of the invention which
would be consistent with the method of the invention. The
principles of the invention can easily be adapted to other
osteotomy instruments (e.g. an oscillating saw, a rotary saw or a
reciprocating saw) to achieve the same results.
[0083] According to the method of the invention, a surgeon can
simultaneously cut or drill bone and irrigate and suction with
essentially no additional effort. Eliminated is the splatter of the
irrigant and cutting debris and also the need for an assistant to
precisely coordinate with the movements of the surgeon as he or she
irrigates and suctions. These benefits however, are secondary to
the main purpose of the apparatus and method of the invention,
namely, the ability to collect the sterile bone particulate
generated by the osteotomy or drilling process for use in the
reconstructive portion of the procedure.
[0084] FIG. 26 illustrates an embodiment of a sterile containment
module 60 for the separation of the bone particles 32 from liquids
33, the liquids comprising irrigant and body fluids. Unlike
traditional hospital suction systems, this is a sterile system so
that the bone particles collected can be reused in the
reconstructive portion of surgery.
[0085] The aspirate from the containment chamber is conveyed though
the sterile vacuum tube 40 to the containment module 60. The
aspirate consists of bone particles, irrigant, small amounts of
tissue, blood and other body fluids. The containment module
comprises three sterile parts: the canister 61, the collection cup
62 and the cover 63. Of course, other embodiments are certainly
possible and would be apparent to those skilled in the art based
upon the disclosures herein. It is envisioned that all three items
would be provided as a sterile unit for single use. All could be
produced (molded) from a clear polymer for visualizing the
contents. The suction tube 40 connects to a fitting 64 molded into
the cover. A second fitting 65 is then connected to the hospital
suction system in a sterile fashion through tube 66. The suction
travels in the direction of the arrows 67. When the aspirate enters
the canister 61, a deflector 68 forces the flow downward and
gravity then separates the contents (solid and liquid) from the air
flow. The solids and liquids fall into the cup 62 and settle to the
bottom where perforations 69 allow the liquid to drain into the
bottom of the canister 61. Optionally the cup may be fitted with a
filter to better trap the smaller bone particles. At the conclusion
of the osteotomy or drilling procedure, the bone particles in the
cup can be left to drain until needed, at which point the cover 63
is removed and the cup 62 is extracted with its sterile contents.
As mentioned previously, the bone particles can then be used "as
is" or mixed with other biological additives for use in the
reconstructive portion of the procedure.
[0086] In today's operating room environment, the contents of the
canister 61 described above are simply suctioned into the
non-sterile hospital system and discarded. A valuable and
much-needed commodity, (autologous) bone graft, is simply wasted
and later replaced with autograft harvested from a second site,
allograft or with alloplastic materials.
* * * * *
References