U.S. patent application number 14/600162 was filed with the patent office on 2015-05-14 for vertebral access system and methods.
The applicant listed for this patent is VIDACARE CORPORATION. Invention is credited to Eric W. EISBRENNER, Larry J. MILLER.
Application Number | 20150129456 14/600162 |
Document ID | / |
Family ID | 40930619 |
Filed Date | 2015-05-14 |
United States Patent
Application |
20150129456 |
Kind Code |
A1 |
MILLER; Larry J. ; et
al. |
May 14, 2015 |
VERTEBRAL ACCESS SYSTEM AND METHODS
Abstract
Medical devices, medical procedure trays, kits and related
methods are provided for use to perform medical procedures that
require access to the interior of a bone. The devices, trays and
methods allow multiple use of non-sterile medical devices with
sterile medical devices for performing medical procedures requiring
sterile conditions.
Inventors: |
MILLER; Larry J.; (Spring
Branch, TX) ; EISBRENNER; Eric W.; (San Antonio,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VIDACARE CORPORATION |
Shavano Park |
TX |
US |
|
|
Family ID: |
40930619 |
Appl. No.: |
14/600162 |
Filed: |
January 20, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12407651 |
Mar 19, 2009 |
8944069 |
|
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14600162 |
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|
11853701 |
Sep 11, 2007 |
8656929 |
|
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12407651 |
|
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60910122 |
Apr 4, 2007 |
|
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60825325 |
Sep 12, 2006 |
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Current U.S.
Class: |
206/571 |
Current CPC
Class: |
A61B 10/025 20130101;
A61B 46/23 20160201; A61B 2017/0649 20130101; A61B 2050/3008
20160201; A61B 50/30 20160201; A61B 2017/0046 20130101; A61B
2050/314 20160201; A61B 46/10 20160201; A61B 50/3001 20160201; A61B
2090/062 20160201; A61B 46/00 20160201; Y10T 29/49826 20150115;
A61B 50/33 20160201; A61B 2017/00734 20130101; A61B 2010/0208
20130101; A61B 2050/0065 20160201; A61B 17/3472 20130101; A61B
2010/0258 20130101; A61B 90/40 20160201 |
Class at
Publication: |
206/571 |
International
Class: |
A61B 19/02 20060101
A61B019/02; A61B 17/34 20060101 A61B017/34; A61B 10/02 20060101
A61B010/02 |
Claims
1. An intraosseous (IO) medical procedures tray comprising: at
least one IO device comprising at least one set of IO needles; the
IO needle set comprising at least one IO needle operable to
penetrate a bone and at least one IO needle operable to deliver a
therapeutic agent to the bone; a coupler assembly comprising a
first end operable to releasably engage one or more IO devices and
a second end operable to releasably engage a powered driver; the
coupler further comprising a sterile containment bag operable to
enclose the powered driver; slots and holders for each component;
and a removable sterile cover over the IO medical procedures tray
to maintain sterility of the components.
2. An intraosseous (IO) medical procedures tray of claim 1, further
comprising other components for placement in the tray from the
group consisting of a containers for sharps, a container for
collecting a medical sample, an ejector funnel, and one or more
smaller trays comprising one or more components of the tray.
3. An intraosseous (IO) medical procedures tray of claim 1, further
comprising selecting IO devices for placement in the tray from the
group consisting of an IO needle operable to penetrate any bone, a
vertebral needle set, a biopsy needle set, an aspiration needle
set, a vertebral needle operable to penetrate a vertebral bone, a
biopsy needle, an aspiration needle, a trocar operable to inject a
therapeutic agent into a bone, an ejector rod operable to inject a
therapeutic agent into a bone, an ejector operable to remove a
biopsy sample from a bone, a rod operable to remove a biopsy sample
from a vertebral bone, a rod operable to be slidably inserted into
a vertebral needle that is operable to penetrate a vertebral bone,
an IO needle operable to inject bone cement into a bone and
combinations thereof.
4. An intraosseous (IO) medical procedures tray of claim 1, wherein
the IO needle set further comprises at least one IO needle operable
to obtain a medical sample from the bone.
5. An intraosseous (IO) medical procedures tray of claim 4, further
comprising other components for placement in the tray from the
group consisting of a containers for sharps, a container for
collecting a medical sample, an ejector funnel, and one or more
smaller trays comprising one or more components of the tray.
6. An intraosseous (IO) medical procedures tray of claim 4, further
comprising selecting IO devices for placement in the tray from the
group consisting of an IO needle operable to penetrate any bone, a
vertebral needle set, a biopsy needle set, an aspiration needle
set, a vertebral needle operable to penetrate a vertebral bone, a
biopsy needle, an aspiration needle, a trocar operable to inject a
therapeutic agent into a bone, an ejector rod operable to inject a
therapeutic agent into a bone, an ejector operable to remove a
biopsy sample from a bone, a rod operable to remove a biopsy sample
from a vertebral bone, a rod operable to be slidably inserted into
a vertebral needle that is operable to penetrate a vertebral bone,
an IO needle operable to inject bone cement into a bone and
combinations thereof.
7. A vertebral medical procedures tray comprising slots and holders
for each component, the components comprising: at least one
vertebral IO device comprising at least one vertebral IO needle
set; the vertebral IO needle set comprising at least one vertebral
IO needle operable to penetrate a vertebral bone and at least one
IO needle operable to deliver a therapeutic agent to the vertebral
bone or a vertebral body; a coupler assembly comprising a first end
operable to releasably engage one or more vertebral IO devices and
a second end operable to releasably engage a non-sterile powered
driver; the coupler further comprising a sterile containment bag
operable to enclose the non-sterile powered driver; and a removable
cover over the vertebral IO medical procedures tray to maintain
sterility of the components.
8. A vertebral medical procedures tray of claim 7, wherein the at
least one IO needle operable to deliver a therapeutic agent to the
vertebral bone or a vertebral body is an IO needle operable to
deliver bone cement into the vertebral bone or the vertebral
body.
9. A vertebral medical procedures tray of claim 7, further
comprising a vertebral biopsy needle set comprising at least one
biopsy needle operable to obtain a medical sample from a vertebral
body.
10. A vertebral medical procedures tray of claim 7, further
comprising a vertebral aspiration needle set comprising at least
one aspiration needle operable to obtain a medical sample from a
vertebral body.
11. A vertebral medical procedures tray of claim 7, further
comprising selecting vertebral IO devices or other components for
placement in the tray from the group consisting of a containers for
sharps, a container for collecting a medical sample, an ejector
funnel, and one or more smaller trays comprising one or more
components of the tray, a vertebral needle set, a biopsy needle
set, an aspiration needle set, a vertebral needle operable to
penetrate a vertebral bone, a biopsy needle, an aspiration needle,
a trocar operable to inject a therapeutic agent into a vertebral
bone, an ejector rod operable to inject a therapeutic agent into a
vertebral bone, an ejector operable to remove a biopsy sample from
a vertebral bone, a rod operable to remove a biopsy sample from a
vertebral bone, a rod operable to be slidably inserted into a
vertebral needle that is operable to penetrate a vertebral bone, an
IO needle operable to inject bone cement into a vertebral body and
combinations thereof.
Description
RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. 120 to U.S.
patent application Ser. No. 12/407,651, filed Mar. 19, 2009, which
is a continuation-in-part application of U.S. patent application
Ser. No. 11/853,701, filed Sep. 11, 2007, which claims the benefit
of U.S. Provisional Patent Application Ser. No. 60/825,325 entitled
"Apparatus and Methods for Biopsy and Aspiration of Bone Marrow"
filed Sep. 12, 2006, and claims the benefit of U.S. Provisional
Patent Application Ser. No. 60/910,122 entitled "Powered Driver
Intraosseous Device and Methods To Access Bone Marrow" filed Apr.
4, 2007. The contents of these applications are incorporated herein
in their entirety by this reference.
TECHNICAL FIELD
[0002] The present disclosure is related generally to non-surgical
medical procedures such as diagnosis, evaluation and treatment of
bones, including factures, vertebral fractures, and/or other
disease or injury to a patient's spine and to medical devices
associated with such procedures. The disclosure also relates to
medical procedure trays and kits for use in conjunction with
diagnostic and therapeutic medical procedures for bone related
disorders.
BACKGROUND OF THE DISCLOSURE
[0003] There are many clinical conditions that require access to
bone tissues, such as bone marrow. In some cases it is important to
access and retrieve bone tissue and/or bone marrow for diagnosis or
treatment of conditions such as but not limited to, osteoporosis,
degenerative bone diseases, fractures, vertebral fractures, cancers
of any type and hematologic disease of any origin. For example, it
may be necessary to access bone tissues and/or bone marrow to
obtain a sample or specimen for diagnostic testing.
[0004] In other cases it may be necessary to introduce a medicament
or a therapeutic agent directly into bone tissue or bone marrow
that may be useful to treat or ameliorate a clinical condition. For
example, it may be necessary to treat diseases with bone marrow or
stem cell transplants to restore functioning blood cells. Such
conditions may include, but are not limited to, acute leukemia,
brain tumors, breast cancer, Hodgkin's disease, multiple myeloma,
neuroblastoma, non-Hodgkin's lymphomas, ovarian cancer, sarcoma and
testicular cancer. In other cases, it may be necessary to treat
conditions such as osteoporosis, degenerative bone disorders, or
fractures by introducing a medicament into the bone or bone
marrow.
[0005] Gaining access to bone and associated bone marrow for a
small biopsy specimen and/or aspiration of a larger quantity of
bone marrow and/or to introduce a medicament may be difficult,
traumatic and occasionally dangerous, depending on each selected
target area for harvesting bone and/or associated bone marrow,
operator expertise and patient. Currently available devices and
techniques for gaining access to a bone and associated bone marrow
may include an intraosseous (IO) needle with a removable trocar
disposed therein. Various shapes and sizes of handles may be used
to apply manual pressure and to manually rotate the IO needle and
removable trocar as a set. Such manual IO devices often require
substantial force to break through the outer cortex of a bone.
Exertion of such force may cause pain to a patient and may
sometimes damage the bone and/or IO device. Such force may
especially cause damage when harvesting bone marrow from children
with softer bone structures or from any patient with bones
deteriorated by disease (osteoporosis, cancer, fractures).
[0006] Occasionally a core specimen of bone and/or bone marrow may
not be successfully retrieved using a standard biopsy needle. Thus,
multiple insertions at different sites may be necessary to obtain a
satisfactory bone and/or bone marrow biopsy specimen. Risks to
health care personnel may be higher because of increased handling
of blood contaminated sharp instruments. Accidental needle sticks
and missed target areas may further complicate procedures and
increase risks to health care personnel and/or patients.
[0007] Conventional bone marrow transplant techniques may require
multiple penetration sites (up to 20 per patient) in order to
obtain enough bone marrow to perform a routine bone marrow
transplant. This procedure is often labor intensive. Conventional
biopsy needles and/or aspiration needles are typically inserted
with considerable manual force. This force may cause loss of
control or operator fatigue. When the biopsy needle or aspiration
needle is in place, an associated trocar is generally removed and a
syringe attached to one end of the needle to aspirate a few cubic
centimeters of bone marrow. The biopsy or aspiration needle is then
withdrawn. A new insertion site may be penetrated, often about a
centimeter from the first insertion site. The procedure may be
repeated multiple times. There is a need for better apparatus and
methods for accessing bone tissue.
[0008] Vertebroplasty may often be performed with a patient sedated
but awake, in a x-ray suite or an operating room. During
vertebroplasty, a bone cement is typically injected under pressure
directly into a fractured vertebra. Once in position, the cement
may harden in about ten minutes or less, depending upon the type of
cement, congealing the fragments of the fractured vertebra and
providing immediate stability.
SUMMARY OF THE DISCLOSURE
[0009] In accordance with the teachings of the present disclosure,
apparatus, devices, medical procedure trays, medical kits, and
therapeutic and diagnostic methods are provided for gaining access
to bone tissue and/or for vascular access through bone tissue.
Access to bone tissue may be used for providing a medicament or a
therapeutic agent to bone tissues and/or to obtain clinical samples
by techniques such as aspiration and/or biopsy of bone marrow. In
some embodiments, the present disclosure provides methods,
apparatus, medical procedure trays and kits for access to vertebral
bones for therapeutic and diagnostic purposes.
[0010] One aspect of the present disclosure may include an
intraosseous (IO) device such as an IO needle set and a coupler
assembly, with a non-sterile driver (manual or power driven)
operable to insert the IO device into a bone and/or associated bone
marrow. The coupler assembly may comprise one end operable to
releasably attach to an IO device and another end operable to
releasably attach to a non-sterile driver. Use of a non-sterile
driver may be facilitated by a containment bag or sterile glove
that is comprised in the coupler assembly and is used to prevent
direct contact of the non-sterile driver with sterile needles and a
patient during a medical procedure such as diagnostic evaluation
and/or providing one or more therapeutic agents to bone. A
non-sterile driver may be used repeatedly in conjunction with
disposable sterile IO needle sets and couplers.
[0011] One aspect of the present disclosure may include placing a
powered driver within a containment bag or sterile enclosure that
may be attached to the first end of a coupler assembly, to provide
isolation between the powered driver and an exterior environment
and maintain a fluid barrier with adjacent portions of driver
housing. The containment bag may be formed from relatively
flexible, lightweight, clear plastic-type materials. The
containment bag may comprise a flexible stay on one side that may
be opened to slide in a powered driver. The containment bag may
further comprise a flap and an adhesive strip that may be used to
seal in the powered driver prior to use, such that a sterile person
does not contact the non-sterile driver. The containment bag may be
attached to the coupler attachment by an adhesive such as hot glue.
However, a wide variety of connecting mechanisms such as, port
assemblies, connectors, receptacles, fittings, hubs, hub
assemblies, latching mechanisms and/or other types of connecting
devices incorporating teachings of the present disclosure may be
satisfactorily used to attach a container bag with the coupler
assembly.
[0012] The end of the coupler assembly at which a containment bag
may be attached may be proximate a tortuous path. A tortuous path
may be a non-linear path and may comprise sharp curves and/or sharp
bends such that bacteria, viruses and/or other pathogens that may
be present on a non-sterile powered driver cannot easily traverse
to cause contamination of a sterile IO device attached at the other
end of the coupler assembly. A tortuous path may also prevent
contamination by bodily fluids that may contain pathogens of
non-sterile and sterile components of medical devices and/or
exposure of personnel performing the medical procedures of the
disclosure to such contaminants.
[0013] A further aspect of the present disclosure may include a
coupler assembly further operable to releasably engage an
intraosseous device with portions of a drive shaft extending from
one end of a powered driver. The coupler assembly may allow the
powered driver to rotate or "spin" an intraosseous device at an
insertion site (power in). The coupler assembly may also allow the
powered driver to rotate or "spin" an intraosseous device during
removal from the insertion site (power out). This feature of the
present disclosure may also be referred to as "power in and power
out."
[0014] Connectors as set forth above may also be used to releasably
engage the coupler with a powered driver and/or the intraosseous
device. In some embodiments, a coupler may comprise a spinner which
may be used to releasably attach an intraosseous device to the
second end of the coupler assembly.
[0015] IO devices and needle sets that may be attached to a coupler
assembly may include one or more of the following: IO
needles/devices/systems operable to provide access to a bone; IO
needles/devices/systems operable to provide one or more therapeutic
agents to bone; IO needles/devices/systems operable to access
vertebral bones; IO needles/devices/systems operable to obtain a
sample of bone and/or bone marrow such as a biopsy needle system or
a bone marrow aspiration system. One or more types of IO
needles/devices/systems may be operable to be releasably attached
to the coupler assemblies of the disclosure based in part by the
application for which the devices, systems and/or methods may be
used for.
[0016] In some aspects, the present disclosure may include medical
procedure trays comprising one or more IO needle sets and/or other
intraosseous devices, a coupler assembly comprising a sterile
containment bag, and optionally comprising a non-sterile power
driver.
[0017] In accordance with the teachings of the present disclosure,
one or more therapeutic agents may be delivered to a bone of a
patient in need thereof A therapeutic agent delivered using the
methods, devices, medical procedure trays, and/or medical kits of
the disclosure may have direct effects on bone tissue or bone
marrow such as but not limited to inducing bone tissue
regeneration, bone strengthening, bone growth, regeneration of bone
marrow, growth inhibition of cancerous cells in bone or bone marrow
or combinations thereof. Alternatively, therapeutic agents may be
delivered via the bone, using the devices and methods of this
disclosure, to the vasculature or other effector sites and may
mediate their therapeutic effects at such other sites. Some
non-limiting exemplary therapeutic agents that may have direct
effects on bone tissue include bone/surgical cements, bone
morphogenetic factors, cartilage-derived morphogenetic factors,
osteogenic factors, differentiating factors, anti-resorption
agents, hormones, growth hormones, nucleic acid constructs encoding
one or more of such agents, or pharmaceutical chemicals.
[0018] One aspect of the present disclosure may include a
therapeutic method that may comprise accessing bone, such as a
fractured bone, by inserting an intraosseous needle or needle set
into a bone using a non-sterile driver and coupler assembly where
the intraosseous needle is operable to deliver a therapeutic agent,
such as a surgical or bone cement, to the fractured bone; and
delivering the therapeutic agent to the bone. In some aspects, the
one or more therapeutic agents may stabilize, and/or strengthen,
and/or regenerate and/or rebuild a fractured bone.
[0019] In an exemplary procedure, an intraosseous needle set may be
used to initially cut through bone using a powered driver and
coupler assembly (power in). An intraosseous needle set may include
a cannula having a single lumen and a trocar or stylet operable to
be slidably disposed within the lumen of the cannula. Various types
of connections including, but not limited to, Luer lock connections
may be used to releasably engage a trocar within a cannula. After
insertion of a cannula into the bone a trocar maybe filled with
surgical cement and maybe slidably disposed into the lumen of the
cannula to inject or deliver the surgical cement into the fractured
bone. After the surgical cement is delivered the trocar may be
slidably removed followed by withdrawal of the cannula using the
powered driver (power out).
[0020] Some non-limiting exemplary uses for methods, devices, and
medical procedure trays of the present disclosure may include use
during various types of procedures for strengthening or repairing
fractured bones, procedures for strengthening or repairing bones
that are weakened (by osteoporosis, aging, degenerative bone
diseases or cancer), for ameliorating and/or relieving pain due to
compression fractures (such as spinal compression fractures),
vertebroplasty procedures to inject bone cements into spinal bones,
procedures for the delivery of one or more therapeutic agents to a
bone, stem cell transplant procedures. Bones of any kind, such as
but not limited to, vertebral bones, neck bones, sternum, rib,
clavicle, femoral, pelvic, wrist and the distal ends of the long
bones may be accessed, evaluated and treated by the present devices
and methods.
[0021] In some aspects, the present disclosure provides medical
procedure trays comprising intraosseous devices for use in
vertebroplasty methods. In some aspects, a medical procedures tray
of the disclosure may be comprised of several smaller trays. For
example, one tray may comprise an IO device/needle sets (e.g.,
designed to penetrate and deliver a therapeutic agent to bone);
another tray may comprise another intraosseous device (e.g.,
designed to obtain a biological specimen from bone or designed to
deliver another therapeutic agent); yet another tray may comprise a
coupler assembly comprising a sterile containment bag. All these
trays may be then packaged into one bigger tray. Typically all the
devices will be sterilized and packaged with appropriate sterile
techniques. The tray may also optionally comprise a non-sterile
powered driver which may be packaged in a separate section of the
tray or provided separately with the tray.
[0022] A vertebral procedure tray may comprise an IO needle set
designed to penetrate into vertebral bones and deliver at least one
therapeutic agent into the vertebral bone. A vertebral needle set
may include a cannula having a lumen and a trocar or stylet
operable to be slidably disposed within the lumen of the cannula
and/or a cutting tip. The vertebral IO needles may be releasably
attached to a first end of the coupler assembly while the
non-sterile power driver may be attached to a second end of the
coupler assembly.
[0023] As vertebral procedures require imaging, such as fluoroscopy
imaging or x-ray imaging techniques, to position a vertebral needle
at the correct insertion site and/or to monitor the injection of
bone cement into a vertebral body, one aspect of the present
disclosure relates to vertebral needles comprising a small hub for
providing the least obstruction to visually viewing the needle and
bone. Some embodiments, relate to the designing small IO needle
hubs that allow for a clear view to an operator while performing a
medical procedure as set forth in the present disclosure.
[0024] A vertebral/medical procedure tray as set forth above may
also comprise a bone and/or bone marrow biopsy system, having a
biopsy needle or biopsy needle set that may be releasably attached
to the first end of the coupler assembly. The biopsy needle set may
include a trocar operable to be slidably or releasably disposed
within the lumen of the vertebral needle set cannula. A single
helical thread may be provided at one end of a biopsy needle to
enhance capture of a biopsy specimen by screwing the single helical
thread into associated cancellous bone to capture a bone marrow
specimen or bone marrow core. A mandrel may be used to wind the
helical thread of a biopsy needle.
[0025] Another exemplary vertebral/medical procedure tray as set
forth above may further comprise a bone marrow aspiration system
having an aspiration needle set that may be releasably attached to
the first end of a coupler assembly, operable to insert the
aspiration needle set into a bone and associated bone marrow. The
aspiration needle set may include a cannula having a single lumen
and a trocar or stylet operable to be slidably disposed within the
lumen of the cannula. The aspiration needle trocar or stylet may
also be introduced into the same cannula as the other IO
device/needle set of the tray. A medical and/or vertebral
procedures tray may comprise an IO device and/or needle set for
delivering a therapeutic agent (e.g., a bone cement, a
pharmaceutical) to a bone; and a coupler assembly as set forth
above, and optionally a biopsy needle set and/or an IO aspiration
needle set.
[0026] The aspiration system and/or biopsy system trays may
comprise containers to store the aspiration/biopsy samples and may
also comprise suitable containers for sharp disposal. Medical
procedure trays comprising aspiration systems and/or biopsy systems
may be used in connection with detection of various bone diseases,
including bone degenerative diseases, osteoporosis, fractures, bone
cancers, detection of spread of metastatic cancers, detection of
spread of infections, and other bone diseases.
[0027] In some embodiments, a medical procedure tray comprising an
aspiration tray and/or a biopsy tray in addition to another IO
device tray may be used to insert an IO needle comprising a cannula
into a bone to provide access to bone; releasably inserting a
biopsy and/or aspiration stylet or trocar to obtain a biological
bone sample for analysis; releasably inserting another IO needle
trocar into the same cannula to deliver a therapeutic agent in to
the bone. In some aspects of this disclosure, a diagnostic test may
be performed at the same time as a therapeutic procedure thereby
reducing the need for multiple insertions of devices into bone and
reducing trauma associated with such procedures.
[0028] Various teaching of the present disclosure may be used with
other types of intraosseous devices and other types of medical
procedures outside the field of providing bone or vascular access
for treatment of a patient. Examples of such procedures may
include, but are not limited to, placement of wires and screws
associated with replacement of joints and internal fixation of bone
fractures and many other orthopedic procedures. Teachings of the
present disclosure may also be incorporated into various
gastroenterology-urology biopsy devices and procedures. Therapeutic
and diagnostic methods and devices of the disclosure may be used in
both acute care and out-patient facilities.
[0029] Another aspect of the present disclosure may include a
medical kit for diagnosis, evaluation and/or treatment of bone. In
some embodiments, the present disclosure provides a vertebroplasty
kit comprising an intraosseous needle set operable to penetrate
vertebral bones and deliver surgical cement into the vertebral
body. A kit of the disclosure may also include a biopsy system
and/or an aspiration system and for simultaneously obtaining a
biopsy and/or bone marrow sample of bone. A kit of the disclosure
may comprise containers to store the biopsy/aspiration samples. A
biological bone sample may be obtained from the same site as the
site of delivery of therapeutic agent (e.g. cement) or may be
obtained from a different site or a different bone.
[0030] A kit of the disclosure may also include one or more sharps
containers. A coupler assembly, operable to be releasably coupled
to a powered driver, the coupler assembly comprising a sterile
container bag may be included. A coupler assembly may have a means
disposed on a first end to releasably attach a powered driver to
the coupler assembly and may have an additional means on a second
end to releasably attach one or more intraosseous needles or biopsy
needles to the coupler. A powered driver may be optionally provided
with a kit of the disclosure or the kit may be usable with
commercially available powered drivers. A kit may optionally
comprise one or more surgical cements and/or therapeutic
agents.
[0031] A further aspect of the present disclosure may include a
biopsy kit along with an intraosseous procedure kit (for example,
vertebroplasty kit), further having a biopsy needle and an ejector
or ejector rod operable to remove a bone and/or bone marrow
specimen from a biopsy needle. A funnel (sometimes referred to as
an "ejector funnel") may also be included within the biopsy kit.
The funnel may accommodate insertion of the ejector into one end of
the biopsy needle. The funnel may include a reduced inside diameter
portion formed in accordance with teachings of the present
disclosure. For some embodiments, interior portions of the funnel
may function as a "one way connector" which may allow the funnel to
function as a sharps protector for one end of the biopsy needle
disposed therein.
[0032] Each component of a kit of the disclosure may be packaged in
one or more containers. In some embodiments, a kit may comprise one
or more components in a first container and/or one or more
components in a second container and so on. Several smaller
containers may be comprised in a bigger container. Each container
or the entire set of containers may be sealed by a paper or plastic
covering.
[0033] Apparatus and methods incorporating teachings of the present
disclosure may: Reduced physical requirements to insert an IO
device into bone and associated bone marrow.
[0034] Better control of an IO device during insertion.
[0035] Increased speed to complete an IO procedure.
[0036] Reduced discomfort to patients.
[0037] Simple, intuitive systems and procedures for an
operator.
[0038] Multiple use of a non-sterile powered driver.
[0039] Availability of components to perform one or more medical
procedures at the same time by providing components in a medical
procedure tray and/or kit.
[0040] Kits with components for procedures such as
vertebroplasty.
[0041] Kits that may further comprise components for biopsy and/or
aspiration procedures and/or diagnostic and/or other therapeutic
procedures.
[0042] Reduced requirement for multiple medical procedures,
multiple insertions and multiple scheduling for patients.
[0043] This summary contains only a limited number of examples of
various embodiments and features of the present disclosure.
Additional examples of embodiments and features will be discussed
in the Detailed Description of the Disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] A more complete and thorough understanding of the present
embodiments and advantages thereof may be acquired by referring to
the following description taken in conjunction with the
accompanying drawings, in which like reference numbers indicate
like features, and wherein:
[0045] FIG. 1A is a schematic drawing showing a plan view of one
example of a medical procedures tray comprising an intraosseous
needle set and a biopsy needle set, each needle set disposed in a
separate tray, and a coupler assembly operable to be releasably
attached to each needle set and to a non-sterile medical device
(e.g., a powered driver, not expressly shown), the coupler assembly
further attached to a sterile container bag and disposed in another
tray incorporating teachings of the present disclosure;
[0046] FIG. 1B is a schematic drawing showing a plan view of one
example of a medical procedures tray comprising an intraosseous
needle set enclosed in a tray and a coupler assembly operable to be
releasably attached to the needle set and to a powered driver (not
shown), the coupler assembly further attached to a sterile
container bag incorporating teachings of the present
disclosure;
[0047] FIG. 1C is a schematic drawing showing an isometric view of
one example of a medical procedures tray comprising an intraosseous
needle set depicting details of the tray incorporating teachings of
the present disclosure;
[0048] FIG. 1D is a schematic drawing showing an isometric view of
one example of a medical procedures tray comprising an intraosseous
biopsy needle set depicting details of the tray incorporating
teachings of the present disclosure;
[0049] FIG. 1E is a schematic drawing in section with portions
broken away showing one example funnel of a medical procedures tray
incorporating the teachings of the present disclosure;
[0050] FIG. 2A is a schematic drawing showing an isometric view of
one example of a medical procedure tray that may include an
intraosseous needle set and/or a biopsy needle set enclosed, each
optionally enclosed in a separate tray, and a coupler assembly
attached to a sterile container bag disposed in another tray, the
coupler operable to be releasably attached to a powered driver (one
example of a non-sterile medical device) as depicted in accordance
with teachings of the present disclosure;
[0051] FIG. 2B is a drawing of a medical procedures tray showing
one example of a sterile container bag with a non-sterile powered
driver disposed therein and the driver attached releasably to a
sterile coupler assembly in accordance with teachings of the
present disclosure;
[0052] FIG. 3A is a schematic drawing showing an isometric view of
a user attaching a non-sterile powered driver to a sterile coupler
assembly attached to a sterile container bag in accordance with
teachings of the present disclosure;
[0053] FIG. 3B is a schematic drawing showing still another
isometric view of a user raising a sterile container bag of FIG. 3A
with a flap and adhesive strip to enclose the non-sterile powered
driver coupled with a sterile coupler assembly in accordance with
teachings of the present disclosure;
[0054] FIG. 3C is a schematic drawing showing an isometric view of
a non-sterile powered driver enclosed in a sterile container bag
comprising a flap and an adhesive strip, wherein the powered driver
is releasably coupled with a sterile coupler assembly and is
further releasably attached to an intraosseous device assembly, in
accordance with teachings of the present disclosure;
[0055] FIG. 4A is a schematic drawing showing an exploded,
isometric view of a powered driver, coupler assembly with a sterile
bag and an intraosseous device incorporating teachings of the
present disclosure;
[0056] FIG. 4B is a schematic drawing showing another exploded,
isometric view of the coupler assembly with the sterile bag of FIG.
4A incorporating teachings of the present disclosure;
[0057] FIG. 4C is a schematic drawing showing one example of a
powered driver operable for use with intraosseous (IO) devices
incorporating teachings of the present disclosure;
[0058] FIG. 5A is a schematic drawing in section with portions
broken away showing a coupler assembly such as in FIGS. 4A and 4B
in a second position showing release of a powered driver from a
receptacle disposed in the first end of the coupler assembly and
showing attachment of a sterile containment bag and a tortuous path
disposed proximate attachment site of containment bag,
incorporating the teachings of the present disclosure;
[0059] FIG. 5B is a schematic drawing in section with portions
broken away showing another example of a coupler assembly
incorporating teachings of the present disclosure;
[0060] FIG. 5C is a schematic drawing in section taken along lines
5C-5C of FIG. 5B, incorporating teachings of the present
disclosure;
[0061] FIG. 5D is a schematic drawing in section taken along lines
5D-5D of FIG. 5A incorporating teachings of the present
disclosure;
[0062] FIG. 6A is a schematic drawing showing an exploded of one
example of an intraosseous needle incorporating teachings of the
present disclosure;
[0063] FIG. 6B is a schematic drawing showing an isometric view of
an intraosseous biopsy needle incorporating teachings of the
present disclosure;
[0064] FIG. 6C is a schematic drawing showing an isometric view of
another intraosseous needle incorporating teachings of the present
disclosure;
[0065] FIG. 7A is a schematic drawing showing an exploded view with
portions broken away of the tips of an intraosseous needle set
incorporating teachings of the present disclosure;
[0066] FIG. 7B is a schematic drawing showing an exploded view with
portions broken away of a beleved tip of an intraosseous needle set
incorporating teachings of the present disclosure;
[0067] FIG. 7C is a schematic drawing showing an exploded view with
portions broken away of the tips of an intraosseous needle set or a
cannula incorporating teachings of the present disclosure;
[0068] FIG. 7D is a schematic drawing showing an exploded view with
portions broken away of the tips of an intraosseous needle set or a
cannula incorporating teachings of the present disclosure;
[0069] FIG. 7E is a schematic drawing showing an exploded view of
one embodiment of the tip of an intraosseous device or cannula
incorporating teachings of the present disclosure;
[0070] FIG. 7F is a schematic drawing showing an exploded view of
still another embodiment of a tip of an intraosseous needle or
device incorporating teachings of the present disclosure;
[0071] FIG. 8A is a schematic drawing partially in section and
partially in elevation with portions broken away showing an
exploded isometric view of a mandrel operable to install a thread
insert within portions of an intraosseous biopsy needle in
accordance with teachings of the present disclosure;
[0072] FIG. 8B is a schematic drawing showing one example of a
thread insert which may be disposed within the longitudinal bore of
an intraosseous biopsy needle in accordance with teachings of the
present disclosure;
[0073] FIG. 8C is a schematic drawing in section with portions
broken away showing one example of an intraosseous biopsy needle
with a single helical thread disposed within one end of the biopsy
needle incorporating teachings of the present disclosure;
[0074] FIG. 8D is a schematic drawing in section with portions
broken away showing another example of an intraosseous biopsy
needle with a single helical thread disposed within one end of the
biopsy needle in accordance with teachings of the present
disclosure;
[0075] FIG. 8E is a schematic drawing in section and in elevation
with portions broken away showing an intraosseous biopsy needle set
including a trocar and a single helical thread disposed proximate
one end of a generally hollow cannula in accordance with teachings
of the present disclosure;
[0076] FIG. 9 is a schematic drawing partially in section showing
an isometric view of an intraosseous needle set penetrating bone
incorporating teachings of the present disclosure;
[0077] FIG. 10A is a schematic drawing partially in section showing
an example of a vertebral procedure using the intraosseous (IO)
medical devices and medical procedures tray, wherein a powered
driver is used to insert an IO device (needle/cannula) into a
vertebral bone, incorporating teachings of the present
disclosure;
[0078] FIG. 10B is a schematic drawing showing partially in section
an example of a vertebral procedure using the intraosseous (IO)
medical devices and medical procedures tray, wherein the powered
device is detached from the intraosseous medical devices leaving
the IO needle/cannula attached to the vertebral bone, incorporating
teachings of the present disclosure;
[0079] FIG. 10C is a schematic drawing partially in section showing
an example of a vertebral procedure using the intraosseous medical
devices and medical procedures tray, a therapeutic agent may be
delivered into the IO needle/cannula, incorporating teachings of
the present disclosure; and
[0080] FIG. 10D is a schematic drawing partially in section showing
an example of a vertebral procedure using the intraosseous medical
devices and medical procedures tray, wherein a trocar (e.g., for
delivering a therapeutic agent, or for obtaining a biopsy) is
inserted into the cannula attached to a vertebral bone,
incorporating teachings of the present disclosure.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0081] Apparatus, medical procedure trays, kits and methods
incorporating teaching of the present disclosure may by used for
diagnostic evaluation and/or for the treatment of various bone
related ailments. Preferred embodiments of the disclosure and
various advantages may be understood by reference to FIGS. 1A-10D,
wherein like numbers refer to same and like parts.
[0082] In some embodiments, teachings of the present disclosure may
be used for therapy and/or repair of fractures, such as but not
limited to, vertebral fractures, or treatment of damaged bones in a
patient's spine. Fractures of the spine are often due to
osteoporosis, a progressive loss of bone tissue which depletes both
collagen and calcium salts from bone. The bone tissue continues to
weaken and is prone to fractures by cracking of the vertebral bones
or by collapsing (compression) of the vertebral bones. People with
osteoporosis rarely have any symptoms until the bone fractures
occur. Vertebral compression fractures may also be caused by
softening of bones due to aging or due to spreading of cancers to
the vertebra or due to other cancers that can weaken bone.
Compression of bony building blocks of the spine (vertebrae) causes
a collapse of the vertebrae much like a sponge collapses under the
pressure of one's hand. A fracture that collapses a spinal vertebra
is called a vertebral compression fracture. Although in some
instances vertebral compression fractures may occur without pain,
these fractures often result in a severe "band-like" pain that
radiates from the spine around both sides of the body. Over many
years, spinal fractures reduce the height of the spine and the
affected person becomes shorter. Conventional treatment of
vertebral compression fractures includes pain medication, resting,
avoiding injury, and using support braces. Therapies such as
vertebroplasty, which involves stabilization of a fractured
vertebral body by injection of a surgical cement, have been used to
treat or ameliorate the symptoms associated with vertebral
fractures.
[0083] Vertebroplasty is a non-surgical procedure, often performed
by a radiologist, and involves inserting a surgical/bone cement
into the center of the collapsed spinal vertebra in order to
stabilize and strengthen the crushed bone. The surgical/bone cement
is a glue-like material (such as poly-methylmethacrylate (PMMA))
and maybe typically inserted with a needle and syringe through
anesthetized skin into the midportion of the vertebra under the
guidance of specialized x-ray equipment. Upon insertion the cement
hardens and forms a cast-like structure within the broken bone. The
casting effect on the broken bone typically provides pain relief
and the newly hardened vertebra protected from further collapse.
Apart from pain relief, vertebroplasty allows better mobility to
patients.
[0084] In some embodiments, the present disclosure provides medical
devices, medical procedure trays, kits and methods for performing
vertebroplasty or other procedures associated with spinal
treatments. A medical procedure tray for performing vetrebroplasty
and/or other spinal procedure may comprise an intraosseous (IO)
device for penetrating vertebral bones such as an vertebral IO
needle set, a coupler assembly, and a driver (manual or power
driven) which may be non-sterile. The coupler assembly may comprise
a containment bag or sterile glove that may be used to prevent
direct contact of a non-sterile driver with a sterile IO device,
operator and patient during a medical procedure. The coupler
assembly may be operable to releasably engage an intraosseous
device with portions of a drive shaft extending from one end of a
powered driver, to obtain a device similar to that depicted in FIG.
3C or 4A. The coupler design allows for multiple use of a
non-sterile driver for such procedures in conjunction with
disposable sterile IO needle sets and couplers. The powered driver
may be used to insert an intraosseous device at an insertion site
(power in) and also allow the powered driver to "spin" the
intraosseous device during removal from the insertion site (power
out). An intraosseous needle set may comprise a cannula having a
lumen and a trocar or a stylet operable to be slidably disposed
within the lumen of the cannula.
[0085] A vertebroplasty method using the devices, kits or trays of
the present disclosure may compose: 1) penetrating a vertebral bone
(fractured/compressed vertebral bone) using an intraosseous needle
comprising a cutting tip and a cannula having a lumen using a
powered driver and coupler assembly in a "power in" mode, the power
driver suitably contained in a containment bag; 2) detaching the
powered driver and coupler assembly from the IO needle inserted
into the bone; 3) filling a trocar or stylet operable to be
slidably disposed within the lumen of the cannula with surgical
cement; 4) slidably disposing the trocar or stylet with surgical
cement into the cannula; 5) injecting the surgical cement into the
fractured bone; 6) detaching the trocar or stylet from the cannula;
7) reattaching the powered driver and coupler assembly to the
cannula; and 8) withdrawing the cannula from the vertebral bone
using the powered driver in a "power out" mode.
[0086] Typically a vertebroplasty procedure in accordance to the
teachings of the disclosure, may utilize a bi-plane fluoroscopy
imaging equipment to achieve accurate needle placement and delivery
of accurate amounts of bone cement. Penetration of bone and depth
of insertion of a needle may be guided by fluoroscopy or other
imaging methods. In some embodiments, an operator may stop
penetration when a decrease in resistance is felt, which may be
indicative of passage through the hard cortex of bone into inner
bone tissues. In some embodiments, for medical procedures that may
require imaging or other visualization to guide an operator to
insert an IO needle/device into a specific insertion site, hubs of
the needle may be designed to be small and unobtrusive to the
visualization method. For other embodiments one or more biopsy
samples may be taken after inserting an intraosseous needle into a
vertebral bone and prior to injecting cement and/or therapeutic
agents into the vertebral bone.
[0087] Various spinal procedures or other medical procedures may be
combined with suitable cleaning, disinfecting the insertion site
prior to insertion of a needle. A patient may be locally or
completely anesthetized based on the need. The site of insertion
may be appropriately dressed and cared for after the procedure.
[0088] The term "containment bag" as used in this application may
include any sterile sleeve, sterile envelope, sterile glove,
sterile enclosure, sterile bag or any other device incorporating
teachings of the present disclosure and operable to allow engaging
a non-sterile device with a sterile device and conducting a medical
procedure requiring a sterile field or sterile environment.
[0089] For some applications a non-sterile powered driver (or
manual driver) may be placed in a containment bag incorporating
teachings of the present disclosure and engaged with a sterile
intraosseous device for use during various medical procedures
requiring a sterile field or sterile environment. Such containment
bags may be attached to a coupler assembly or any other device
incorporating teachings of the present disclosure to prevent the
non-sterile powered driver from contaminating the sterile
intraosseous (IO) device during and after engagement of the
non-sterile powered driver with the IO device.
[0090] The term "driver" as used in this application may include
any type of powered driver (or manual driver) satisfactory for
inserting an intraosseous (IO) device into a selected portion of a
patient's bone. Such powered drivers often rotate a drive shaft
extending therefrom. However, various teachings of the present
disclosure may be used with powered drivers that reciprocate an
associated drive shaft (not expressly shown).
[0091] Various techniques may be satisfactorily used to releasably
engage or attach an IO device with a powered driver in accordance
with teachings of the present disclosure. For example a wide
variety of coupler assemblies, port assemblies, connectors,
receptacles, fittings, hubs, hub assemblies, latching mechanisms
and/or other types of connecting devices incorporating teachings of
the present disclosure may be satisfactorily used to releasably
engage an IO device with a powered driver.
[0092] Various types of coupler assemblies incorporating teachings
of the present disclosure may be satisfactorily used to releasably
engage one end of a shaft extending from a driver with one end of
an intraosseous device. For some embodiments the powered driver may
include a drive shaft having one end with a generally hexagonal
cross section operable to be releasably engaged with a latch
mechanism disposed in one end of a coupler assembly. For some
embodiments a coupler assembly incorporating teachings of the
present disclosure may be referred to as a "hands free" coupler, a
quick disconnect or quick release coupler and/or port assembly.
[0093] Respective latch mechanisms may be disposed proximate a
first end and a second end of a coupler assembly in accordance with
teachings of the present disclosure. Pushing one end of a drive
shaft extending from a powered driver into the second end of the
coupler assembly may result in an annular recess disposed in the
one end of the drive shaft "snapping" into releasable engagement
with the respective latch mechanism. Pushing one end of an
intraosseous device into the first end of the coupler assembly may
result in an annular recess in the one end of the intraosseous
device "snapping" into releasable engagement with the respective
latch mechanism.
[0094] For some embodiments, a coupler assembly or port assembly
may be engaged with a containment bag or sterile sleeve in
accordance with teachings of the present disclosure. Coupler
assemblies and/or hub assemblies incorporating teachings of the
present disclosure allow easy separation of an associated powered
driver from an IO device such that the IO device may remain in
place in a patient to allow bone marrow aspiration or removal of
bone and/or bone marrow biopsy specimens. Such coupler assemblies
and/or port assemblies may also allow an associated powered driver
to "spin" or rotate an attached IO device while withdrawing an IO
device from an insertion site or changing the depth of penetration
of an IO device in a target area. Rotating the IO device during
withdrawal or changing depth (power out) may substantially improve
patient comfort and reduce potential trauma to bone and soft body
tissue proximate an insertion site.
[0095] A powered driver may be used to insert an IO device
incorporating teachings of the present disclosure into a selected
target area or target site in ten seconds or less. However, various
teachings of the present disclosure are not limited to use with
powered drivers. Manual drivers and spring powered drivers may also
be used with IO devices incorporating teachings of the present
disclosure.
[0096] Examples of manual drivers are shown in copending patent
application Ser. No. 11/042,912 entitled Manual Intraosseous Device
filed Jan. 25, 2005 (now U.S. Pat. No. 8,641,715).
[0097] The term "fluid" may be used in this application to include
liquids such as, but not limited to, blood, water, saline
solutions, IV solutions, plasma or any mixture of liquids,
particulate matter, dissolved medication and/or drugs associated
with biopsy or aspiration of bone marrow or communication of fluids
with bone marrow or other target sites. The term "fluid" may also
be used in this patent application to include any body fluids
and/or liquids containing particulate matter such as bone marrow
and/or cells which may be withdrawn from a target area.
[0098] The terms "harvest" and "harvesting" may be used in this
application to include bone and/or bone marrow biopsy and bone
marrow aspiration. Bone and/or bone marrow biopsy (sometimes
referred to as "needle biopsy") may be generally described as
removing a relatively small piece or specimen of bone and/or bone
marrow from a selected target area for biopsy purposes. Bone marrow
aspiration (sometimes referred to as "bone marrow sampling") may be
generally described as removing larger quantities of bone marrow
from a selected target area. Relatively large quantities of bone
marrow may be used for diagnostic, transplantation and/or research
purposes. For example some stem cell research techniques may
require relatively large quantities of bone marrow.
[0099] The terms "insertion site," "penetration site," and
"installation site" may be used in this application to describe a
location on a bone at which an intraosseous device may be inserted
or drilled into the bone and associated bone marrow. Insertion
sites, penetration sites and installation sites are generally
covered by skin and soft tissue. For example, for a vertebral
procedure an insertion site may be a vertebral disc bone.
[0100] The term "intraosseous (IO) device" may be used in this
application to include, but is not limited to, any hollow needle,
hollow drill bit, penetrator assembly, bone penetrator, catheter,
cannula, trocar, stylet, inner penetrator, outer penetrator, IO
needle, biopsy needle, aspiration needle, IO needle set, biopsy
needle set or aspiration needle set operable to penetrate and/or
provide access to an intraosseous space or interior portions of a
bone. Such IO devices may be formed, at least in part, from metal
alloys such as 304 stainless steel and other biocompatible
materials associated with needles and similar medical devices.
[0101] Various types of IO devices may be formed in accordance with
teachings of the present disclosure. Examples of such IO devices
may include, but are not limited to, IO needle sets for delivering
therapeutic agents, IO needle sets for delivering a bone cement,
vertebral IO needles, biopsy needles, biopsy needle sets,
aspiration needles and aspiration needle sets. However, a wide
variety of other IO devices may be formed in accordance with one or
more teachings of the present disclosure. Such IO devices may or
may not include a trocar and/or a stylet.
[0102] For some applications, a trocar and/or a stylet may be
inserted into a generally hollow, longitudinal bore or lumen in an
associated catheter or cannula. The first end of the second hub may
be releasably engaged with second end of the first hub to
releasably dispose the stylet or trocar within the longitudinal
bore of the cannula or catheter. The present disclosure is not
limited to IO needle sets such as therapeutic agent delivery IO
needle sets, vertebral IO needles, aspiration needle sets, or
biopsy needle sets as discussed in this application.
[0103] The term "target area" may be used in this application to
describe selected portions of a bone cavity or locations in a bone
cavity into which a therapeutic agent may be delivered or from
which associated bone tissue and/or bone marrow may be harvested in
accordance with teachings of the present disclosure.
[0104] Many currently available techniques for providing a
therapeutic agent and obtaining a bone sample and/or harvesting
bone and/or bone marrow may require more than one penetration into
a bone and associated bone marrow to retrieve an adequate sample of
bone and/or bone marrow. Separate diagnostic and therapeutic
procedures are normally required even for diagnosis and therapy to
the same bone, thereby requiring multiple insertions into the same
bone at different times. Further, multiple penetration sites may be
required in the same bone if a biopsy specimen is not
satisfactorily retrieved at the first penetration site. Medical
personnel may need to insert an IO needle into several different
penetration sites on the same bone to obtain adequate quantities of
bone marrow for transplant or stem cell research. For example
obtaining sufficient quantities of bone marrow from a patient's
pelvis may require six or more insertion sites. Multiple insertions
may be extremely painful for a patient and may deter some people
from donating bone marrow. Multiple insertions may also cause
fatigue in medical personnel performing such procedures with manual
IO devices. Multiple scheduling for therapeutic procedures separate
from diagnostic procedures also adds to trauma and cost for a
patient.
[0105] For some applications, an IO needle or other IO device may
be formed with a first end operable to penetrate bone and/or
associated bone marrow. A connector or hub may be attached to a
second end of the IO needle or other IO device. Such connectors or
hubs may be operable to releasably engage the IO needle or IO
device with a powered driver, a manual driver and/or a coupler
assembly.
[0106] IO needle sets and other IO devices incorporating teachings
of the present disclosure may include a first IO device such as a
cannula, catheter or outer penetrator and a second IO device such
as a stylet, trocar, syringe, or inner penetrator. Various types of
cutting surfaces may be formed proximate a first end of the first
IO device and a first end of the second IO device. The cutting
surface of the first IO device and the cutting surface of the
second IO device may cooperate with each other to penetrate bone
and/or associated bone marrow.
[0107] A first connector or first hub may be used to releasably
engage the first IO needle or IO device with the second IO needle
or IO device. For example an IO needle set may include a first
connector or a first hub with a generally hollow cannula, catheter
or outer penetrator attached thereto and extending from a first end
of the first hub. A second end of the first hub may be operable to
be releasably engaged with a first end of a second connector or a
second hub. A stylet, trocar or inner penetrator may also be
attached to and extend from the first end of the second hub. The
second end of the first hub may include an opening sized to allow
inserting the stylet, trocar or inner penetrator through the
opening and a lumen in the cannula, catheter or outer
penetrator.
[0108] A second end of the second hub may be operable to be
releasably engaged with a first end of a coupler assembly
incorporating teachings of the present disclosure. One end of a
shaft extending from a powered driver or a manual driver may be
releasably engaged with a second end of the coupler assembly.
[0109] In some embodiments of the present disclosure, the
dimensions of the hubs may be designed to be unobtrusive or
minimally obtrusive to an imaging method that may be used to image
the site of insertion and a medical procedure being performed such
as the delivery of a medicament to a specific site.
[0110] Additional details concerning powered drivers, connectors,
hubs, and IO devices may be found in co-pending patent application
entitled "Powered Driver Intraosseous Device and Methods To Access
Bone Marrow," Ser. No. 12/061,944, filed Apr. 3, 2008, which claims
priority from a provisional patent application with the same title
filed on Apr. 4, 2007.
[0111] Various features of the present disclosure may be described
with respect to powered driver 200, coupler assemblies 250 and
250a, hub assemblies 130 (130a, 130b, 130c and 130d), hubs, 96,
140, 150, IO needle sets 100, 100A, 100b, 100c and 100d, including
IO needles, vertebral needles, IO biopsy needles, IO aspiration
needles, and containment bag 170. However, the present disclosure
is not limited to such powered drivers, coupler assemblies, hub
assemblies, IO needle sets, and/or containment bags. A wide variety
of intraosseous devices, hub assemblies, coupler assemblies and/or
containment bags may be formed in accordance with teachings of the
present disclosure with various dimensions and/or
configurations.
[0112] FIGS. 1A and 1B show some examples of medical procedure
trays and/or kits which may contain one or more intraosseous
devices and/or other components incorporating teachings of the
present disclosure. For example, medical procedure tray 20 as shown
in FIG. 1A may include a first tray 20a comprising an intraosseous
needle set with needles 100a and 100b (e.g., an IO needle set for
penetration and delivery of a medicament to a vertebral bone),
funnel 80 and sharps container 64; a second tray 20b comprising an
intraosseous biopsy needle set with needles 100c and 100d, funnel
80 and sharps container 64 incorporating various teachings of the
present disclosure; and a third tray 20c comprising a coupler
assembly 250, containment bag 170, feet 5 and second end of the
coupler assembly 252 that may be releasably attached to power
driver 200 (not expressly shown). Feet 5 provide support for tray
20c. Trays 20a, 20b and 20c may be enclosed in tray 20 and covered
with a detachable paper or plastic wrap 2. In some embodiments, an
additional tray comprising an IO aspiration system for obtaining
bone marrow may also be comprised in tray 20 (not expressly
depicted).
[0113] For delivery of a therapeutic agent to bone and/or for
removal of a biological specimen from a bone the needles 100b or
100d as depicted in FIGS. 1A and 1B may also be referred to as an
"ejector rod." An ejector rod, such as 100b or 100d, may be
slidably disposed into a hollow cannula 100 of an IO needle to
deliver a medicament or obtain a biological sample from a bone. In
the case of a biopsy ejector rod, a helical thread, operable to be
wound back by a mandrel, may be disposed in the cannula. Upon
contact with bone tissue the helical thread may be would back to
retrieve the biopsy sample.
[0114] The length of ejectors 100b or 100d may be selected to be
greater than the length of a lumen in an associated IO needle.
Handle or hub 96 may be disposed on second end 92 of ejectors 100b
or 100d. See FIG. 1D. The dimensions and configuration of first end
91 of ejector rod 100b or 100d may be selected to be compatible
with inserting first end 91 through an opening in the first end 111
of an associated IO and/or biopsy needle 100. Various types of
ejectors, ejector rods, funnels and/or ejector funnels may also be
used with an IO needle, a vertebral needle, an IO biopsy needle, IO
aspirator needle and/or other intraosseous devices incorporating
teachings of the present disclosure.
[0115] Medical procedure tray 20 as shown in FIG. 1B may include
first tray 20a comprising an intraosseous needle set 100a and 100b
(for example, vertebral IO needles), funnels 80 and sharps
container 64; and second tray 20c comprising a coupler assembly
250, containment bag 170, feet 5 and second end of the coupler
assembly 252 that may be releasably attached to power driver 200
(not expressly shown). IO needle sets 100 may comprise one or more
cannulas, stylets, trocars, and/or cutting needle tips. Feet 5
provide support for tray 20c. Trays 20a, 20b and 20c may be
enclosed in tray 20 and covered with a detachable paper or plastic
wrap 2.
[0116] Medical procedure trays and/or kits formed in accordance
with teachings of the present disclosure may provide a support or
base for various components such as one or more of the following:
IO devices and needles 100, coupler assembly 250, funnel 80 and/or
sharps protector 64 to allow an operator or user to perform various
functions without requiring that the operator or user hold or
manipulate the respective component. For example medical procedure
tray 20c as shown in FIGS. 1A and 1B may position and support
coupler assembly 250 such that one end of a powered driver 200 may
be inserted (pushed) into releasable engagement with second end 252
of coupler assembly 250. The powered driver 200 may then be used to
withdraw coupler assembly 250 from medical procedure tray 20c
without requiring an operator or user to directly hold or
manipulate coupler assembly 250.
[0117] FIG. 1E depicts a detailed structure of funnels 80 of FIGS.
1A, 1B, 1C and 1D. Funnel 80a, as in FIG. 1E, may be positioned and
supported within medical procedure trays 20a or 20b such that one
end of an intraosseous device may be inserted (pushed) into funnel
80a. Funnel 80a may be withdrawn from medical procedure tray 20a
and/or 20b without requiring that an operator or user directly hold
or manipulate funnel 80a.
[0118] Funnel 80a may be slidably disposed in holder 56 in medical
procedure tray 20a in a generally vertical position. See FIGS. 1A,
1B, 1C and 1D. As a result, first end 81a of funnel 80a may be
oriented in a position to allow inserting one end of IO biopsy
needles such as the cannula depicted herein as 100a or 100c
therein. Longitudinal passageway 84 proximate first end 81 a may
include a sticking tapered portion operable to maintain contact
with one end of an IO set such as the outer cannula 100a or 100c.
An IO needle set or cannula may then be manipulated to pull funnel
80a from holder 56. Funnel 80a may serve as a sharps protector for
the one end of an intraosseous device inserted therein.
[0119] For some applications, funnels formed in accordance with
teachings of the present disclosure may include a respective first
opening formed at a first end and a respective second opening at a
second end of the funnel. The first opening and the second opening
may have different inside diameters. For example, the first opening
may be sized to accommodate inserting an IO needle, a vertebral
needle and/or a biopsy needle therein while the second opening may
have a reduced inside diameter which prevents inserting the needle
therein. The second opening may be sized to only accommodate one
end of an associated ejector rod. For some applications, a
longitudinal passageway may extend between the first end and the
second end of the funnel. Tapered surfaces may be formed within the
longitudinal passageway adjacent to the first end. The tapered
surfaces may function as a "one way" connector such that when an IO
needle, a vertebral needle, and/or an IO biopsy needle is inserted
therein, the funnel will be securely engaged with the first end of
the needle. The funnel may then function as a sharps protector for
the first end of the needle.
[0120] Each sharps protector 64 may also be positioned and
supported within medical procedure trays 20a and/or 20b to allow
inserting (pushing) one end of an intraosseous device or any other
medical device requiring sharps protection into sharps protector 64
without requiring that an operator or user to directly hold or
manipulate the associated sharps protector 64. Medical procedure
trays 20, 20a, 20b, 20c, coupler assemblies 250 and other
components formed in accordance with teachings of the present
disclosure may substantially reduce the number of opportunities for
an accidental "needle stick" and/or dropping, contaminating or
other problems associated with handling and manipulating various
components disposed within an associated medical procedure
tray.
[0121] Medical procedure trays and kits formed in accordance with
teachings of the present disclosure may have a wide variety of
configurations and/or dimensions. For some applications, a kit
holding intraosseous devices in accordance with teachings of the
present disclosure may have an overall length of approximately four
and one-half inches, a width of approximately three inches and a
depth of approximately two inches. Various heat sealing techniques
may be satisfactorily used to place a removable cover (not
expressly shown) over a medical procedure tray or kit incorporating
teachings of the present disclosure.
[0122] Sharps protectors 64 may include hard foam or claylike
material 66 disposed therein. Intraosseous devices such as
vertebral needle sets, other IO needle sets, aspiration needle sets
and biopsy needle sets typically have respective sharp tips and/or
cutting surface operable to penetrate skin, soft tissue and bone.
The sharp tips and/or cutting surface of such intraosseous devices
may be inserted into hard foam or claylike material 66 after
completion of a medical procedure using the respective intraosseous
device.
[0123] For some applications, medical procedure tray 20 or 20a may
be referred to variously as a `vertebral procedure tray," and/or
"vertebroplasty tray," and/or a "tray for providing access to
deliver therapeutic agents to bone," and/or a "therapeutic and
diagnostic procedures tray." For some applications, medical
procedure tray 20b may sometimes be referred to as "bone and/or
bone marrow biopsy procedure trays" or "biopsy procedure trays" or
"bone marrow biopsy kits." For some applications, medical procedure
tray 20a may be referred to as a "bone marrow aspiration tray,"
"aspiration procedure tray" or "bone marrow aspiration kit". For
some applications, medical procedures tray 20c may be referred to
as "coupler assembly tray" or "sterile glove tray."
[0124] Medical procedure trays 20a, 20b and/or 20c may be formed
from various polymeric materials compatible with sterile packaging
and storage of various components disposed within each medical
procedure tray. For some applications ethylene oxide sterilization
techniques may be used during assembly and packaging of medical
procedure trays 20a, 20b and 20c. However, other sterilization
procedures may be used as appropriate.
[0125] In some embodiments, medical procedures trays of the
disclosure may be stored at temperatures ranging from between about
-20.degree. C. to about 50.degree. C.
[0126] Respective covers (not expressly shown) may be placed over
each medical procedure tray 20a, 20b and 20c as part of an
associated sterilization and packaging process. Such covers may be
removed prior to use of various components disposed within each
medical procedure tray. A respective cover 2 may be placed on the
main tray 20 that comprises two or more of trays 20a, 20b and/or
20c.
[0127] Medical procedure tray, vertebroplasty tray, vertebral
procedure tray, diagnostic and therapeutic tray, or tray for
providing a medicament to a bone, 20a (see FIG. 1C) may include
elongated slot 22 with appropriate dimensions for an associated
intraosseous device such as, but not limited to, IO needle set 100,
or 100a and 100b. The dimensions and configuration of slot 22 may
be selected to accommodate the combined length of hub assembly 130
and cannula 110a extending therefrom. One end of slot 22 may be
sized to accommodate the dimensions and configuration of hub
assembly 130. Enlarged openings or finger slots 24 may also be
provided to accommodate inserting and removing IO needle set 100
from slot 22. Various details associated with IO needle set 100
will be discussed later with respect to FIG. 6A-8E.
[0128] In FIGS. 1C and 1D, sharps protector 64 may be disposed
within holder 26 of medical procedure tray 20a or 20b. A pair of
finger slots 28 may also be formed in tray 20a or 20b to
accommodate inserting and removing sharps protector 64 from holder
26a. Holder 26b may also be formed in tray 20a along with
associated finger slots 28. An additional sharps protector or other
components may be disposed within holder 26b. The
dimensions/configurations of slot 22 and holders 26a and 26b may be
varied as desired for respective components which will be disposed
therein.
[0129] Medical procedure trays 20b (See FIG. 10) may include
elongated slots 30 and 32. The dimensions and configuration of
elongated slot 30 may be selected to accommodate placing ejector
110d therein. The dimensions and configuration of elongated slot 32
may be selected to accommodate placing an intraosseous device such
as a biopsy system with biopsy needle set 100c and 100d therein (as
depicted) or an aspiration system with an aspiration needle (not
depicted).
[0130] One end of elongated slot 30 may have configuration and
dimensions selected to accommodate the configuration and dimensions
of handle 96 disposed on second end 92 of injector rod 100d (See
FIG. 1D). A pair of finger slots 34 may be formed as part of
elongated slot 30 to allow installing and removing ejector 100d.
One end of elongated slot 32 may be operable to accommodate the
configuration and dimensions associated with hub assembly 130a of
IO biopsy needle set 100c. A pair of finger slots 36 may also be
provided as part of elongated slot 32 to accommodate inserting and
removing IO biopsy needle set 100c from elongated slot 32.
[0131] Tray 20b may also include holder 38 disposed adjacent to
elongated slot 30. Holder 38 may have a configuration and
dimensions compatible with releasably placing funnel 80 therein.
One or more specimen or sample containers or cups (not expressly
shown) may be provided in biopsy tray 20b. Biopsy specimen or
sample containers may include a cavity sized to receive a biopsy
specimen from biopsy needle set 100c and 100d. Funnel holders 38
may be formed in biopsy procedure tray 20b adjacent to ejector 100d
to ensure that funnel 80 is readily available to assist with
removing a biopsy specimen from biopsy needle set 100d.
[0132] Medical procedure trays 20 as shown in FIGS. 2A and 2B
represent other example of a medical procedure tray formed in
accordance with teachings of the present disclosure. FIGS. 2A and
2B depict trays that comprise medical procedure tray 20c and either
trays 20a and 20b; or 20c and 20a or 20b. Containment bag 170 and
power driver 200 are also shown. FIG. 2B shows power driver 200
being enclosed in containment bag 170. Containment bag 170 may
comprise a flexible stay 180, a flap 174, and may further comprise
an adhesive strip 4 all of which may be used to contain a
non-sterile power driver 200 and prevent contamination of IO
devices, IO needles or coupler by the non-sterile power driver.
Containment bag 170 may also prevent contamination of the power
driver 200 by pathogens in bodily fluids that may leak out during a
medical procedure. The configuration and dimensions of flexible
stay 180 may be selected to accommodate inserting and removing a
powered driver or other non-sterile medical device therefrom.
[0133] A combined medical procedure tray(s) (such as 20 in FIG. 1A
or 20 in FIG. 1B) may be sterilized after being assembled. One
benefit of such sterilization may include, but is not limited to,
providing a sterilized containment bag which may be used to engage
a non-sterile medical device with a sterile medical device in
accordance with teachings of the present disclosure.
[0134] One of the benefits of the present disclosure may include
being able to releasably engage one end 211 of a powered driver 200
with one end 252 of a coupler assembly 250, releasably engage one
end 102 of an IO needle 100 (such as a vertebral needle or a biopsy
needle) with an opposite end 251 of the coupler assembly 250,
insert "power in" another end 101 of the IO needle 100 into a
selected target area, deliver one or more medicaments into the
target area using one or more components of an IO device or needle
set 100, "power out" the IO needle 100 with a high degree of
confidence that a specimen (such as a biopsy sample) will be
disposed therein and insert the other end 101 of the IO needle into
a funnel to provide both sharps protection and removal/storage of
the specimen. Any direct contact between an operator and the IO
needle may be limited to pushing one end of the IO needle into a
respective end of the coupler assembly.
[0135] Another benefit of the present disclosure is to insert
"power in" a first IO needle (such as a cannula) into a bone to
provide access to the bone followed by slidably inserting a second
IO needle (such as a trocar) into the first IO needle. The second
needle may be operable to deliver a therapeutic agent to bone or
may be operable to obtain a specimen from bone. The second needle
may be slidably removed from the first IO needle. In one example, a
second needle may be a biopsy needle that may be inserted into the
cannula of a first needle to obtain a biopsy and slidably removed
after the sample is obtained. Another needle, a third IO needle (a
trocar) operable to deliver a therapeutic agent may then be
slidably inserted into the first needle (cannula) and a therapeutic
agent may be delivered. Multiple needles may be inserted for
different diagnostic/therapeutic purposes repeatedly through the
first cannula needle without the need for multiple insertions into
bone. Upon completion of the medical procedures the first needle
may then be "powered out". In some embodiments, the medical
procedure devices and trays and methods of the present disclosure
may be used to perform multiple procedures with one insertion into
the bone.
[0136] A pair of holders or clamps 26, 26a, 26b (FIGS. 2A and 2B)
may also be formed in medical procedure tray 20c adjacent to holder
for coupler assembly 250. Such clamps 26a and 26b may be designed
to respectively accommodate first end 181 and second end 182 of
flexible stay 180 disposed on opening 172 of containment bag 170.
Coupler assembly 250 may also be installed in holder 58 of coupler
assembly tray 20c with first end 251 down and second end 252
looking up. FIGS. 2A and 2B shows a power driver 200 being placed
on second end 252 of a coupler assembly 250 in exemplary tray 20,
where exemplary tray 20 comprises tray 20c as described above and
may comprise trays 20a and 20b or tray 20a or may even comprise a
tray 20d (not depicted). FIG. 2B depicts a raised bag 170 covering
powered driver 200, showing features of the containment bag 170
including flap 174, opening 172, flexible stay 180, respective ends
181 and 182 of the flexible stay, and adhesive strip 4 in an
exemplary medical procedures tray as described earlier in this
paragraph. However, the present disclosure is not limited to using
flaps and adhesive materials to close an opening in a containment
bag and other means may be used to close and seal a containment
bag.
[0137] FIGS. 3A-3C illustrate one procedure for placing a powered
driver 200 within containment bag 170 incorporating teachings of
the present disclosure. Containment bag 170 may be formed from
generally flexible, fluid impervious material such as a plastic,
which may also be sterilized using conventional sterilization
techniques. Containment bag 170 may be used to prevent a
non-sterile powered driver 200 from contaminating a sterile
intraosseous device 100 and/or a patient, particularly during an IO
therapeutic and/or IO diagnostic procedure. Containment bag 170 may
be operable to form a fluid barrier with adjacent portions of
housing assembly 270 of coupler assembly 250. At the same time,
coupler assembly 250 may allow powered driver to rotate an
intraosseous device 100 releasably engaged with first end 251 of
coupler assembly 250 without damage to containment bag 170.
[0138] A non-sterile person (not expressly shown) may next insert
power driver 200 into coupler assembly 250 and extend containment
bag 170 (FIGS. 3A-3C). First end 181 and second end 182 of flexible
stay 180 may be removed from respective clamps or holders in
medical procedure tray 20c to allow manually lifting second opening
172 upwardly relative to powered driver 200. See FIGS. 2A-2B and
3A-3C. Containment bag 170 may continue to be raised to a fully
extended position with powered driver 200 disposed therein. See
FIG. 3B. Flap 174 may then be placed over second opening 172 and
further sealed using the adhesive strip 4 proximate 172.
Containment bag 170 with powered driver 200 disposed therein and
coupler assembly 250 may then be removed from holder 58 of medical
procedure tray 20c (FIGS. 2A-2B). Various commercially available
low strength adhesive materials may be satisfactorily used to
provide releasable engagement between flap 174 proximate opening
172 of containment bag 170.
[0139] Housing assembly 270 and/or housing segments 280 and 290 of
coupler assembly 250 may remain relatively stationary during
rotation of elongated core 260. In some embodiments, spinner 10 may
be rotated for insertion and securing of IO device at end 251. See
FIGS. 3A-3C and 4A-4B. For example portions of housing assembly 270
such as flange 254 extending from second end 252 of coupler
assembly 250 may be attached to containment bag 170 and remain
relatively stationary while powered driver 200 rotates elongated
core 260 and IO needle set 100 extending therefrom.
[0140] For some applications, powered driver 200 may be directly
placed into a containment bag 170 and engaged with coupler assembly
250. For other applications, a non-sterile powered driver may be
inserted into containment bag 170 in connection with removing
coupler assembly 250 from a medical procedure tray.
[0141] For some applications, a protective cover (not expressly
shown) may be removed from medical procedure tray 20c. End 224
extending from drive shaft 222 of powered driver 200 may then be
inserted through opening 172 of containment bag 170 and releasably
engaged with second end 252 of coupler assembly 250 (see FIG. 4C
and FIGS. 3A-3C).
[0142] Typical procedures associated with using a medical procedure
tray or kit incorporating teachings of the present disclosure may
include the following steps. Medical procedure tray 20 may be
placed at a desired location for performing an associated medical
procedure. For example medical procedure tray 20 may be placed on a
table or cart adjacent to a surgical table on which a bone
therapeutic procedure, a vertebral procedure, a bone or bone marrow
biopsy procedure, and/or a bone marrow aspiration procedure may be
performed.
[0143] An associated cover 2 may be removed from medical procedure
tray 20 by a sterile person. A non-sterile person may then pick up
and insert non-sterile powered driver 200 into flexible stay 180
such as shown in FIG. 3A. End 224 of drive shaft 222 of powered
driver 200 may "snap" into place within second end 252 of coupler
assembly 250. A sterile person may then lift containment bag 170 up
and over powered driver 200 (as shown in FIG. 3B), and fold flap
174 over to secure with adhesive strip 4 which will result in
containing the power driver 200 (not expressly shown).
[0144] The sterile person may then grasp handle 214 of powered
driver 200 through containment bag 170 and lift powered driver 200
with coupler assembly 250 attached thereto from holder 58 disposed
in tray 20c. The sterile person may then remove an intraosseous
(IO) device/needle 100 from medical procedure trays 20a or 20b and
insert second end 102 of IO device/needle 100 into first end 251 of
coupler assembly 250. A "snap" may be felt when second end 102 of
IO device/needle 100 (or any other intraosseous device
incorporating teachings of the present disclosure) is releasably
latched within first end 251 of coupler assembly 250. A needle
safety cap (not expressly shown) may be removed from first end 101
of IO needle 100 after releasably engaging second end 102 with
first end 251 of coupler assembly 250.
[0145] Powered driver 200 disposed within containment bag 170 along
with coupler assembly 250 and IO needle 100 extending there from
may be held in one hand while a sterile person identifies the
insertion site with the other hand. Powered driver 200 may be
positioned over the insertion site to introduce first end 101 of IO
needle set 100 through the skin in the direction and towards the
bone. Upon contact with the bone the operator may squeeze button or
trigger 246 and apply relatively steady gentle pressure to handle
214 of powered driver 200. Upon penetration of the bone cortex, the
operator may release trigger 246 to stop further insertion of first
end 101 of IO needle 100.
[0146] First housing segment 280 may then be activated to release
second end 102 of IO needle 110a from engagement with coupler
assembly 250. Second hub 150a may then be rotated counterclockwise
to disengage second hub 150a and associated stylet 120 from first
hub 140a. See FIGS. 5A-5B and 6A-6C. Stylet 120 may then be pulled
out and removed from IO needle or cannula 111a. First end 121 of
stylet 120 (FIG. 6C) may then be inserted into sharps protector 64
of medical procedure tray 20. Upon completion of an appropriate IO
procedure second hub 150a may be reengaged with first hub 140a (see
FIGS. 6A and 6B). First end 251 of coupler assembly 250 may then be
reengaged with second end 102 of IO needle set 100a to rotate or
spin IO needle set 100a while withdrawing from the insertion site.
After removal from the insertion site, second end 102 of IO needle
set 100a may be disengaged from coupler assembly 250. First end 101
of IO needle set 100a may then be inserted into sharps container
64.
[0147] In general, after completion of a bone related medical
procedure, such as vertebroplasty, other spinal procedures,
delivery of a medicament to a bone, a bone marrow aspiration
procedure, a bone and/or bone marrow biopsy procedure and/or other
medical procedures using an IO device 100, the sharp end or sharp
tip of all components of the intraosseous device may be inserted
into material 66 in sharp protector 64 for further disposal in
accordance with the appropriate procedures.
[0148] Powered driver 200 as shown in FIGS. 3A-3C, and 4A-4C may be
satisfactorily used to insert an intraosseous device incorporating
teachings of the present disclosure into a bone and associated bone
marrow. However the disclosure is not limited to this particular
power driver and any power driver may be used to practice the
present embodiments.
[0149] Powered driver 200 may include housing 210 having a general
configuration similar to a small pistol defined in part by handle
214. Various components associated with powered driver 200 may be
disposed within housing 210 including handle 214. For example a
power source such as battery pack 216 may be disposed within handle
214. Battery pack 216 may have various configurations and
dimensions. Battery pack may comprise a lithium chloride
battery.
[0150] Housing 210 including handle 214 may be formed from
relatively strong, heavy duty polymeric materials such as
polycarbonates or other satisfactory materials. For some
applications housing 210 may be formed in two halves (not expressly
shown) which may be joined together with a fluid tight seal to
protect various components of powered driver 200 disposed
therein.
[0151] Motor 218 and gear assembly 220 may be disposed within
portions of housing 210 adjacent to handle 214. Motor 218 and gear
assembly 220 may be generally aligned with each other. Motor 218
may be rotatably engaged with one end of gear assembly 220. Drive
shaft 222 may be rotatably engaged with and extend from another end
of gear assembly 220 opposite from motor 218. For some applications
both motor 218 and gear assembly 220 may have generally cylindrical
configurations.
[0152] Motors and gear assemblies satisfactory for use with powered
driver 200 may be obtained from various vendors. Such motor and
gear assemblies may be ordered as "sets" with one end of each motor
securely attached to an adjacent end of an associated gear
assembly. A drive shaft having various dimensions and/or
configurations may extend from the gear assembly opposite from the
motor. Such gear assemblies may sometimes be referred to as
"reduction gears" or "planetary gears". The dimensions and/or
configuration of housing 210 may be modified to accommodate an
associated motor and gear assembly.
[0153] Distal end or first end 211 of housing 210 may include an
opening (not expressly shown) with portions of drive shaft 222
extending therefrom. For some applications end 224 or the portion
of drive shaft 222 extending from first end 211 of housing 210 may
have a generally hexagonal cross section with surfaces 226 disposed
thereon. Receptacle 263 disposed in second end 252 of coupler
assembly 250 may have a matching generally hexagonal cross section.
See FIGS. 5A-5B.
[0154] Surfaces 226 may extend generally parallel with each other
and parallel with respect to a longitudinal axis or rotational axis
(not expressly shown) associated with drive shaft 222. One or more
tapered surfaces 228 may also be formed on end 224 to assist with
releasably engaging powered driver 200 with coupler assembly 250.
See FIGS. 5A-5B. The end of a drive shaft extending from a powered
driver may have a wide variety of configurations.
[0155] A drive shaft having desired dimensions and configuration
may extend from the gear assembly opposite from the motor. The
drive shaft may be provided as part of each motor and gear assembly
set. The dimensions and/or configuration of an associated housing
may be modified in accordance with teachings of the present
disclosure to accommodate various types of motors, gear assemblies
and/or drive shafts. For example, powered drivers used with
vertebral IO needles, aspiration needles and/or biopsy needles may
include gear assemblies with larger dimensions required to
accommodate larger speed reduction ratios, for example between 60:1
and 80:1, resulting in slower drive shaft RPM's. Powered drivers
used to provide intraosseous access during emergency medical
procedures may operate at a higher speed and may include gear
assemblies having a smaller speed reduction ratio, for example
between 10:1 and 30:1, resulting in higher drive shaft RPM's. For
some applications, the difference in size for gear assemblies may
result in increasing the inside diameter of an associated housing
by approximately two to three millimeters to accommodate larger
gear assemblies associated with powered drivers used to insert
vertebral JO needles, biopsy needles and/or aspiration needles.
[0156] Coupler assemblies having corresponding openings or
receptacles may be releasably engaged with end 224 extending from
first end 211 of powered driver 200 or end 224a extending from
first end 211 of powered driver 200a. For example, end 224
extending from first end 211 of housing 210 may be releasably
engaged with receptacle 264 disposed proximate second end 252 of
coupler assembly 250 as shown in FIGS. 1A-1B, 2A-2B, 3A-3C and
5A-5D.
[0157] For some applications thrust bearing 241 may be disposed
between first end or distal end 211 of housing 210 and adjacent
portions of gear assembly 220. See FIG. 4C. Thrust bearing 242 may
be disposed between second end or proximal end 212 of housing 210
and adjacent portions of motor 218. Thrust bearings 241 and 242 may
limit longitudinal movement of motor 218, gear assembly 220 and
drive shaft 222 within associated portions of housing 210.
[0158] Trigger assembly 244 may also be disposed within housing 210
proximate handle 214. Trigger assembly 244 may include trigger or
contact switch 246. See FIG. 4C. Motor 218 may be energized and
deenergized by alternately depressing and releasing trigger 246.
Electrical circuit board 247 may also be disposed within housing
210. Electrical circuit board 247 may be electrically coupled with
trigger assembly 244, motor 218, power supply 216 and indicator
light 248.
[0159] For some applications indicator light 248 may be a light
emitting diode (LED) or a small more conventional light bulb. For
some applications indicator light 248 may be activated when ninety
percent (90%) of electrical storage capacity of battery pack 216
has been used.
[0160] The configuration and dimensions of an intraosseous device
formed in accordance with teachings of the present disclosure may
vary depending upon respective intended applications for each
intraosseous device. For example, the length of a vertebral IO
needle formed in accordance with teachings of the present
disclosure may vary from approximately about 5 inches to about 10
inches. In one non-limiting example a vertebral IO needle may be
about 6 inches (or 152 millimeters). However, vertebral needles
with other lengths may also be made in accordance with the
teachings of this disclosure.
[0161] The length of a biopsy needle formed in accordance with
teachings of the present disclosure may vary from approximately
five (5) millimeters to thirty (30) millimeters. However, biopsy
needles having other lengths may also be formed in accordance with
teachings of the present disclosure.
[0162] Aspiration needles formed in accordance with teachings of
the present disclosure may have lengths of approximately twenty
five (25) millimeters, sixty (60) millimeters and ninety (90)
millimeters. For some applications an aspiration needle having a
length of ninety (90) millimeters or more may also include one or
more side ports. See for example FIGS. 6A-6C.
[0163] Further details about IO biopsy systems and needle sets and
IO aspirations systems may be found in co-pending U.S. patent
application Ser. No. 11/853,678 filed on Sep. 11, 2007
(073252.0204).
[0164] Intraosseous (IO) devices formed in accordance with
teachings of the present disclosure may have outside diameters and
longitudinal bores or lumens corresponding generally with eighteen
(18) gauge to ten (10) gauge needles. For example, a vertebral IO
needle may have a cannula with an eight (8) gauge to eleven (11)
gauge diameter while an biopsy needle that may be inserted inside
the vertebral cannula may have a diameter of fifteen (15) gauge to
sixteen (16) gauge. The configuration and dimensions of each IO
device may depend upon the size of an associated bone and desired
depth of penetration of associated bone marrow. In one specific
non-limiting example, a vertebral IO needle set may comprise a
beveled cutting tip and a stylet and may be an 11 gauge, 152
millimeter needle, made of 304 stainless steel.
[0165] Combining a powered driver with a coupler assembly and a
vertebral needle set in accordance with teachings of the present
disclosure may allow rapid access to the vertebral or spinal bones
or other insertion sites. Vertebral access systems incorporating
teachings of the present disclosure may be capable of inserting a
vertebral needle to a desired depth in cancellous bone in ten (10)
to fifteen (15) seconds. This same capability may be used to obtain
bone marrow using the bone marrow aspiration systems as well as
biopsy specimen of bone and/or bone marrow using the biopsy needles
of the present disclosure.
[0166] Intraosseous (IO) needle sets, such as vertebral IO needles
100a and 100b, biopsy needles 100c and 100d and aspiration needle
100e as shown in FIGS. 1A-1B and/or FIGS. 6A-6C represent only some
examples of intraosseous devices formed in accordance with
teachings of the present disclosure. All the IO needles may have
similar outer penetrators or cannulas 110a and similar inner
penetrators to stylets 120. See FIGS. 6A-6C. Similar or different
hub assemblies 130 or 130a may be used.
[0167] For embodiments represented by IO needle sets 100 and 100a,
first end 111a of cannula 110a and first end 121 of stylet 120 may
be operable to penetrate a bone and/or associated bone marrow.
Various features of first end 111a of cannula 110a and first end
121 of stylet 120 are shown in more detail in FIGS. 7A-7F. First
end 101 of IO needle sets 100 and 100a may correspond generally
with first end 111a of cannula 110a and first end 121 of stylet
120.
[0168] Cannula 110a may have a plurality of markings 104 disposed
on exterior portions thereof Markings 104 may sometimes be referred
to as "positioning marks" or "depth indicators." Markings 104 may
be used to indicate the depth of penetration of the IO needle set
100 or 100a into a bone (e.g. vertebral bone) and/or associated
bone marrow. For some applications cannula 110a may have a length
of approximately sixty (60) millimeters and may have a nominal
outside diameter of approximately 0.017 inches corresponding
generally with a sixteen (16) gauge needle. In some applications, a
cannula 110a may be an 8-11 gauge needle and an inner trocar such
as a biopsy or cement trocar may be a 15-16 gauge needle. Cannula
110a may be formed from stainless steel or other suitable
biocompatible materials. Positioning marks 104 may be spaced
approximately one (1) centimeter from each other on exterior
portions of cannula 110a.
[0169] Hub assembly 130 as shown in FIGS. 6A-6C may be used to
releasably dispose stylet 120 within longitudinal bore or lumen 118
of cannula 110a. Hub assembly 130 may include first hub 140 and
second hub 150. The second end of cannula 110a, opposite from first
end 111a, may be securely engaged with the second end of cannula
110a. The second end of stylet 120, opposite from first end 121,
may be securely engaged with the first end of hub 150.
[0170] As shown in FIG. 6A cannula 110a may extend longitudinally
from first end 141 of hub 140. Stylet 120 may also extend from the
first end of hub 150 (not expressly shown). The second end of hub
140 may include a standard Luer lock fitting which may be
releasably engaged with a corresponding Luer lock fitting disposed
within the first end of second hub 150. Threaded connections may be
present between the second end of first hub 140 and the first end
of second hub 150 (not expressly shown). Examples of Luer lock
connections and/or fittings are shown in more detail in FIGS.
6A-6C. The Luer lock fitting disposed on the second end of hub 140
may be operable to be releasably engaged with a standard syringe
type fitting and/or a standard intravenous (IV) connection.
[0171] Hub 150 includes second end 152 which generally corresponds
with second end 132 of hub assembly 130 and second end 102 of IO
needle set 100. Hub 140 may include first end 141 which may
generally correspond with first end 131 of hub assembly 130.
Cannula 110a may extend longitudinally from first end 141 of hub
140 and first end 131 of hub assembly 130.
[0172] Various types of receptacles may be satisfactory disposed in
second end 152 of hub 150 for use in releasably engaging hub
assembly 130 with a powered driver. For example, a receptacle
having a generally tapered configuration corresponding with the
tapered configuration of one end of a drive shaft extending from a
powered driver may be releasably engaged with second end 152 of hub
150. Powered driver 200 as shown in FIGS. 4A-4C may represent one
example of a powered driver having a drive shaft extending from a
housing with a tapered portion operable to be releasably engaged
with a receptacle having a corresponding generally tapered
configuration. For some applications such powered drivers may be
secured to an intraosseous device by a magnet (not expressly shown)
disposed on the end of the tapered shaft extending from the powered
driver and a metal disk disposed within a corresponding receptacle
in the intraosseous devices. Such powered drivers may also be used
with intraosseous devices used to obtain emergency vascular access
(EVA).
[0173] The coupler assembly as depicted in FIGS. 5A and 5B depicts
how containment bag 170 is attached to the coupler. Containment bag
170 is attached proximate end 252 of the coupler. In some
embodiments, the containment bag may be attached using a hot glue
gun. However, a wide variety of attachment mechanisms such as but
not limited to coupler assemblies, port assemblies, connectors,
receptacles, fittings, hubs, hub assemblies, latching mechanisms
and/or other types of connecting devices incorporating teachings of
the present disclosure may be satisfactorily used to attach the
container bag with the coupler assembly.
[0174] A "tortuous path" 14 is defined proximate attachment of bag
170 and the body of the coupler. A tortuous path 14 may be a
non-linear path such that bodily fluids that may contain bacteria,
viruses or other pathogens cannot easily traverse to cause
contamination of a sterile IO device attached at end 251 of the
coupler. A tortuous path may comprise sharp curves. If a pathogen
falls into a part of the tortuous path the sharp curves and edges
prevent the pathogen from reaching sterile surfaces on the other
side.
[0175] For other embodiments, the second end of a hub assembly may
be operable to be disposed within a receptacle formed in a coupler
assembly incorporating teachings of the present disclosure. One
feature of the present disclosure may include forming a hub
assembly which may be releasably engaged within a first receptacle
disposed in a first end 251 of a coupler assembly 250. See for
example receptacle 263 proximate first end 261 of elongated core
260 as shown in FIG. 5A-5D. The dimensions and configuration of
receptacle 263 may be selected to prevent rotation of hub 150a
relative to hub 140a while inserting (rotating) an IO device into a
bone and associated bone marrow. The powered driver may be
releasably engaged with a second receptacle disposed in a second
end 252 of the coupler assembly. See for example receptacle 264
proximate second end 262 of elongated core 260 as shown in FIGS.
5A-5B.
[0176] At least one portion of hub assembly 130a may have a
generally hexagonal cross section operable to be received within
the generally hexagonal cross section of receptacle 264 disposed
proximate first end 251 of coupler assembly 250. See FIGS. 5C and
5D. For some embodiments portions of first hub 140a disposed
adjacent to reduced outside diameter portion 143 may have generally
hexagonal cross sections. See FIGS. 6A and 6B. Various cross
sections other than hexagonal may be satisfactorily used to
releasably engage a powered driver with one end of a coupler
assembly and an intraosseous device with an opposite end of the
coupler assembly.
[0177] Aspiration needle sets may often include a trocar, stylet or
penetrator in combination with an associated cannula, catheter or
outer penetrator. However, biopsy needles formed in accordance with
teachings of the present disclosure may or may not include a
trocar, stylet or inner penetrator. For example, biopsy needle 100c
is shown in FIG. 6B attached to first end of hub 140a. A stylet or
inner penetrator is not attached to first end 151 of hub 150a.
[0178] For embodiments represented by biopsy needle 100c, hub 140a
may be used to releasably engage biopsy needle 100c in a receptacle
formed in a coupler assembly incorporating teachings of the present
disclosure. Hub 150a may be attached to close of end 141 of hub
140a. However, for many applications hub 140a without hub 150a may
be connected with one end of a coupler assembly in accordance with
teachings of the present disclosure. Biopsy needle 100c may be used
to capture a biopsy specimen of a bone and associated bone marrow.
Placing a trocar within biopsy needle 100c may result in
substantial damage to the bone specimen during penetration of the
bone by the combined tips of the trocar and biopsy needle 100c.
[0179] Hub 140a may include second end 142 with opening 144 formed
therein. Passageway 146 may extend from second end 142 towards
first end 141 of hub 140a. Passageway 146 may be operable to
communicate fluids with lumen 118 of cannula 100a. See FIGS. 6A-6C
and FIGS. 7A-7F. Second end 142 of hub 140 may include various
features of a conventional Luer lock connection or fitting,
including threads 148. Corresponding threads 158 may be formed
within first end 151 of hub 150a. The dimensions and configuration
of receptacle 263 in first end 251 of coupler assembly 250 may be
selected to prevent relative movement between hub 140a and hub 150a
during insertion (rotation) of an IO device into a bone and
associated bone marrow. If such relative movement occurs, threads
148 and 158 may be disconnected.
[0180] For some applications hub 140a and hub 150a may be formed
using injection molding techniques. For such embodiments hub 140a
may include reduced outside diameter portion 143 disposed between
first end 141 and second end 142. In a similar manner a plurality
of void spaces or cutouts 153 may be formed in hub 150a adjacent to
and extending from second end 152 in the direction of first end
151. See for example FIGS. 6A, 6B and 4A. The configuration and
dimensions of reduced diameter portion 143 and/or cutouts 153 may
be varied to optimize associated injection molding techniques and
at the same time provide required configurations, dimensions and
material strength to allow associated hub assembly 130a to function
in accordance with teachings of the present disclosure.
[0181] FIGS. 7A and 7B show one example of cutting surfaces and
tips which may be formed adjacent to the ends of a cannula and an
associated trocar in accordance with teachings of the present
disclosure. For embodiments represented by cannula or outer
penetrator 110a and trocar or inner penetrator 120a, tip 123 of
stylet 120 may be disposed relatively close to tip 113 of cannula
110a. For some applications, first end 121 of trocar 120 and first
end 111 a of cannula 110a may be ground at the same time to form
adjacent cutting surfaces 114 and 124. Grinding ends 111a and 121
at the same time may result in forming a single cutting unit to
form generally matching cutting edges 124e and 114e such as shown
in FIGS. 7A and 7B. Beveled cutting surfaced and/or serrated
cutting surfaces may be used in some embodiments. Other types of
cutting surfaces formed in accordance with teachings of the present
disclosure may be discussed later.
[0182] First end 121 of trocar 120 may extend through opening 144
in second end 142 of hub 140a. See FIG. 6A. Hub 150a disposed on
the second end of trocar 120 may be releasably engaged with the
second end of cannula 110a represented by hub 140a. See FIG.
6B.
[0183] Human bones may generally be described as having a hard
outer lamellae or layer of osseous tissue known as "cortical bone".
Cancellous bone (also known as trabecular or spongy bone) typically
fills an inner cavity associated with cortical bone. Cancellous
bone is another type of osseous tissue with generally low density
and strength but high surface area. Cancellous bone typically
includes spicules or trabeculae which form a latticework of
interstices filled with connective tissue or bone marrow. Exterior
portions of cancellous bone generally contain red bone marrow which
produces blood cellular components. Most of the arteries and veins
of a bone are located in the associated cancellous bone.
[0184] One of the benefits of the present disclosure may include
providing various vertebral intraosseous devices including, but not
limited to, vertebroplasty needles, vertebral biopsy needle sets
configured to reliably provide a therapeutic agent and adapted to
obtain biopsy specimens of cortical bone and/or cancellous bone by
reducing need for multiple procedures/insertions in a patient.
[0185] The configuration of the tip of a cannula or outer
penetrator may be modified in accordance with teachings of the
present disclosure to provide optimum torque during insertion of
the cannula or outer penetrator by a powered driver to penetrate
bone for a therapeutic or diagnostic procedure. A controlled,
steady feed rate when using a powered driver may result in higher
quality delivery of therapeutic agent (cement) and/or obtaining
biopsy specimens as compared to manually inserted IO needles. A
needle comprising a beveled cutting tip, such as a stylet may be
used to initially penetrate bone. The cutting tip may be
retractable and withdrawn after insertion of a cannula comprising
the beveled cutting tip. A rod shaped needle/cannula, containing
one or more therapeutic agents (such as but not limited to a bone
cement), configured to inject the therapeutic agent, may be
disposed within the hollow cannula that has a tip making contact
with the interior of the bone. In embodiments wherein a biopsy
sample is desired, a biopsy rod/trocar may also be inserted into
the hollow cannula. A biopsy rod may have a helical thread disposed
within proximate an associate tip or first end to assist with
capturing a bone and/or bone marrow biopsy specimen.
[0186] The quality and reliability of a medical procedure
incorporating teachings of the present disclosure may be
substantially improved by using an optimum feed rate for inserting
and IO needle into a bone and associated bone marrow. Feed rate or
speed of insertion of an IO biopsy needle incorporating teachings
of the present disclosure may be a function of the pitch of at
least one thread disposed on an interior portion of the biopsy
needle and revolutions per minute (RPM) of the biopsy needle.
RPM=Feed rate.times.Pitch of threads
[0187] Helical thread 190 as shown in FIGS. 8A-8D may have a pitch
of approximately twenty four (24) threads per inch. An optimum
pitch may vary based on factors such as reduction gear ratio (77:1
for some embodiments) and load placed on an associated motor.
[0188] Further technical benefits may include reducing physical
requirements and mental stress on users and decreasing pain and
stress on patients by increasing speed and control of the needle
set insertion during vertebral procedures or other bone procedures
and by decreasing the number of procedures performed and the number
of times a bone is drilled into.
[0189] For some applications, an IO needle formed in accordance
with teachings of the present disclosure may include a hollow
cannula or catheter having one end formed by electrical discharge
machining (EDM) techniques, grinding techniques and/or other
machining techniques. A plurality of teeth may be formed on one end
of the cannula or catheter using EDM techniques, grinding
techniques and/or other machining techniques.
[0190] For some embodiments a stylet or trocar may also be disposed
within the cannula or catheter with a first end of the stylet
extending from a first end of the cannula or catheter. Increasing
the length of the first end of the stylet or trocar extending from
the first end of the cannula or catheter may reduce the amount of
torque or force required to penetrate a bone and may reduce time
required for an associated IO needle set, vertebral needle set,
biopsy needle set, aspiration needle set or to penetrate the bone
and associated bone marrow.
[0191] A specific powered driver, intraosseous device and tip
configuration will generally produce the same torque when drilling
in a hard bone or a soft bone. However, the time required to drill
to a first depth in a hard bone will generally be greater than the
time required to drill to similar depth in a soft bone.
[0192] For still other embodiments, teeth formed on one end of a
cannula or catheter may be bent radially outward to reduce the
amount of time and/or force required to penetrate a bone and
associated bone marrow using the cannula or catheter. For some
applications a powered driver and vertebral needle set, aspiration
needle set or biopsy needle set formed in accordance with teachings
of the present disclosure may provide access to a patient's bone
using a similar amount of torque. The length of time for
penetrating a relatively hard bone may be increased as compared
with the length of time required to penetrate a relatively softer
bone.
[0193] The tips of several stylets and cannulas incorporating
teachings of the present disclosure were slowly ground with coolant
to prevent possible thermal damage to metal alloys or spring
material used to form the stylets and cannulas. The stylets and
cannulas were assembled into respective IO needle sets. The tips of
each needle set were inserted into sawbones blocks under controlled
test conditions. Some testing was conducted with Pacific Research
sawbones blocks. The tips of the needle sets were inserted to a
depth of approximately two centimeters with ten pounds (10 lbs) of
force and twelve volts direct current (12 VDC) applied to an
associated powered driver. There was no measurable or visual wear
of the stylet or cannula tips after completion of the testing.
[0194] For some embodiments a generally hollow biopsy needle may be
substantially continuously rotated at an optimum speed or RPM
during insertion into a selected target area to obtain a biopsy
specimen. The biopsy needle may include a longitudinal bore
extending from a first, open end of the needle to a second, open
end of the needle. A small helical thread may be formed on interior
portions of the longitudinal bore proximate the first end. For some
embodiments the thread may have a pitch similar to threads used on
conventional wood screws. The rate of rotation or revolutions per
minute (RPM) of the biopsy needle may be selected by installing a
gear assembly with a desired speed reduction ratio (typically
between 60:1 and 80:1) between a motor and an associated drive
shaft. For some applications the gear assembly may reduce speed of
rotation of an attached motor at a ratio of approximately 66:1 or
77:1.
[0195] Outer penetrator or cannula 110f as shown in FIG. 7C may
include first end 111f having a plurality of cutting surfaces 114f
formed adjacent to opening 116 in first end 111f. Opening 116 may
communicate with and form a portion of an associated longitudinal
bore or lumen 118. For some applications cutting surfaces 114f may
be formed using electrical discharge machining (EDM)
techniques.
[0196] Cannula 110f as shown in FIG. 7C may have a cutting surface
or tooth 114f protruding outward followed by the next cutting
surface or tooth 114f protruding inward resulting in a cross-cut
saw-type pattern. For some medical applications, a cannula such as
110f may be used effectively. The pattern of the cutting surfaces
may be effective to obtain a biopsy sample since the teeth
extending outward may form a passageway (not expressly shown) with
an inside diameter larger than a corresponding outside diameter of
the cannula. The teeth extending inward may form a sample of bone
and/or bone marrow (not expressly shown), having a generally
cylindrical configuration with an outside diameter smaller than a
corresponding inside diameter of the cannula. The result of such
"cross cutting" may be less friction between exterior portions of
the cannula and adjacent bone and/or bone marrow and less damage to
a biopsy sample disposed within the lumen of the cannula.
[0197] For embodiments such as shown in FIG. 7D, outer penetrator
or cannula 110g may include first end 111g having a generally
tapered configuration or reduced outside diameter as compared with
other portions of cannula 110g. A plurality of cutting surfaces
114g may be disposed on end 111g adjacent to respective opening
116. For some applications, cutting surfaces 114g may be formed
using machine grinding techniques. For embodiments end 111g of
cannula 110g may include six ground cutting surfaces 114g with
respective crowns 115 may be formed therebetween. Forming a biopsy
needle set and/or biopsy needle with tapered end 111g and a
plurality of cutting surfaces 114g and crowns 115 may provide
improved drilling performance when the resulting biopsy needle set
and/or biopsy needle is used with a powered driver in accordance
with teachings of the present disclosure.
[0198] For some applications, helical groove 117 may be formed
within longitudinal bore 118 proximate respective opening 116.
Helical groove 117 may assist with retaining a biopsy specimen or a
bone marrow specimen within longitudinal bore 118.
[0199] Testing conducted with cannulas or outer penetrators formed
in accordance with teachings of the present disclosure indicated
that forming cutting surfaces or cutting teeth with electrical
discharge machining (EDM) sometimes resulted in the associated
cannula or outer penetrator being able to drill through a bone and
associated bone marrow slightly faster than a cannula or outer
penetrator having cutting surfaces formed using grinding
techniques. Some test results also indicated that bending cutting
surfaces formed on one end of a cannula or outer penetrator in
accordance with teachings of the present disclosure may reduce the
amount of time and/or the amount of force required to remove a bone
and/or bone marrow specimen from a target area.
[0200] Intraosseous needle set or biopsy needle set 100g is shown
in FIGS. 7E and 7F. Biopsy needle set 100g may include cannula or
outer penetrator 110g with stylet or inner penetrator 120g slidably
disposed therein. First end 101 of biopsy needle set 100g is shown
in FIGS. 7E and 7F. For some applications first end 101 of biopsy
needle set 100g may minimize damage to skin and soft body tissue at
an insertion site.
[0201] For some applications inner penetrator or trocar 120g may
include first end 121 having a plurality of cutting surfaces 125
and 126 formed on exterior portions thereof extending from
associated tip 123 towards second end of trocar or inner penetrator
120g. For some applications one or more cutting surfaces 125 may be
formed having length 127 extending from tip 123 to associated
cutting surfaces 114g in associated cannula 110g. One or more
cutting surfaces 126 may be formed adjacent to each cutting surface
125 with second length 128. First length 127 may be greater than
second length 128. The ratio of first length 127 and second length
128 may be varied in accordance with teachings of the present
disclosure to provide optimum performance for penetrating a
selected bone and associated bone marrow.
[0202] For some applications, a single thread may be disposed
within the longitudinal bore or lumen of a biopsy needle, cannula,
catheter or outer penetrator in accordance with teachings of the
present disclosure. Various techniques and procedures may be
satisfactorily used to place the single thread within a generally
hollow cannula or outer penetrator proximate one end of the cannula
or outer penetrator having one end operable to penetrate a bone
and/or associated bone marrow. For some embodiments, a helical coil
having a configuration and dimensions associated with the resulting
single thread may be placed on one end of a mandrel such as a spot
welding electrode assembly. The mandrel or electrode assembly may
then be inserted through an opening in the one end of the cannula
or outer penetrator operable to penetrate a bone and/or associated
bone marrow. The helical coil may then be bonded with adjacent
portions of cannula. Coils having a wide variety of dimensions and
configurations may be satisfactorily used to place a single thread
in a biopsy needle.
[0203] For embodiments such as shown in FIGS. 8A-8E, examples of
helical threads are shown disposed in biopsy needles or cannulas
incorporating teachings of the present disclosure. Outer penetrator
or cannula 110h as shown in FIG. 8A may be formed with longitudinal
bore 118 or lumen 118 extending from open 116 through cannula 110h.
Electrode assembly or mandrel 160 may be used to install (spot
weld) a single helical thread in lumen 118 proximate opening
116.
[0204] Helical coil 192 as shown in FIG. 8B may be placed on first
end 161 of electrode assembly 160. Helical coil 192 may have the
cross section of a right triangle. First end or copper electrode
161 may have an appropriate configuration and dimensions to be
slidably received within opening 116 formed in first end 111 of
cannula or outer penetrator 110h. First end or copper electrode 161
of mandrel 160 may include corresponding groove 164 with a
configuration and dimensions satisfactory to receive helical coil
192 therein. Groove 164 may be formed with a desired pitch for
resulting thread 190 when attached to or bonded with interior
portions of cannula 110h.
[0205] For some applications electrode assembly 160 may include
enlarged outside diameter portion or plastic insulator 194 disposed
adjacent to first end 161. The dimensions and/or configuration of
copper electrode 161 and plastic insulator 194 may be selected to
accommodate installing helical coil 192 at an optimum location
relative to end 116 for retaining biopsy specimens in lumen 118.
For example, the dimensions and configuration of plastic insulator
194 may be selected to contact the extreme end of outer penetrator
or cannula 110h proximate crowns 115.
[0206] Copper electrode 161 of electrode assembly 160 with helical
coil 192 attached thereto may be inserted into opening 116 in first
end 111h of cannula 110h. Electrode assembly 160 may be operable to
conduct electricity to copper electrode 161 to accommodate spot
welding helical coil 192 with adjacent interior portions of
longitudinal bore 118 of cannula 110h. For some embodiments mandrel
160 may be formed from materials compatible with laser welding
helical coil 192 with interior portions of lumen or longitudinal
bore 118 of cannula 110h. When attached to interior portions of a
cannula or outer penetrator 110h, helical coil 192 may form a
single thread having shoulder 191 extending generally perpendicular
to adjacent interior portions of lumen 118. The resulting
dimensions and configuration of helical thread 190 may be selected
to optimize retaining a specimen of bone and/or bone marrow on
shoulder 191 of thread 190 within lumen 118.
[0207] Cannula 110c of biopsy needle 100c is shown in FIG. 8C with
helical thread 190 disposed therein. The combination of helical
thread 190 with shoulder 191 extending substantially perpendicular
to interior portions of lumen 118 may increase the reliability of
biopsy needle 100c to retain a specimen of bone and/or bone marrow.
For some applications combining helical thread 190 with cutting
surfaces 114 and crowns 115 may substantially increase the
reliability of obtaining a satisfactory bone specimen when using
biopsy needle 100c with a powered driver in accordance with
teachings of the present disclosure.
[0208] Helical thread 190 may be positioned at an optimum location
relative to opening 116 in cannula 110c to begin capture of a bone
marrow specimen or cancellous bone core. By inserting biopsy needle
100c at an optimum feed corresponding with the pitch of helical
thread 190, helical thread 190 may be "screwed in" cancellous bone
entering opening 116 to substantially increase the probability of
capturing a satisfactory biopsy specimen or bone marrow core.
[0209] For embodiments such as shown in FIG. 8D cannula or outer
penetrator 110d may include first end 111d having a plurality of
exterior cutting surfaces 114d formed thereon and extending
therefrom. The length of cutting surfaces 114d may be longer than
the length of corresponding cutting surfaces 114. Respective crowns
115d may be formed between adjacent cutting surfaces 114d and
114g.
[0210] For some applications a helical thread having a generally
"wedge shaped" cross section similar to an equilateral triangle may
be disposed within the longitudinal bore or lumen of an outer
penetrator or cannula incorporating teachings of the present
disclosure. For example cannula 110d may include helical thread
190a having a generally wedge shaped cross section corresponding
approximately with an equilateral triangle. Helical thread 190a may
be installed within cannula 110d using apparatus and procedures as
previously described with respect to helical thread 190.
[0211] FIG. 8E shows an example of combining inner penetrator or
stylet 120c with cannula or outer penetrator 110c having helical
thread 190 disposed therein to form biopsy needle set 100c in
accordance with teachings of the present disclosure. Biopsy needle
100c is shown in FIGS. 6B and 8C without a stylet or trocar. Biopsy
needle set 100c is shown in FIG. 8E with trocar or stylet 120c
disposed in cannula 110c. Trocar 120c may include end 121c with a
pair of cutting surfaces 125 and a pair of cutting surface 126 as
shown in FIG. 7F. Surfaces 125 and 126 may cooperate with each
other to form a cutting tip on trocar or stylet 120c similar to a
"chisel point" drill bit. The pair of cutting surfaces 125 may be
offset (relief angle) approximately eight degrees relative to the
pair of cutting surfaces 126. The included angle of cutting
surfaces 125 may be approximately thirty four degrees (34.degree.)
plus or minus four degrees (.+-.4.degree.). The included angle of
cutting surfaces 126 may be approximately sixteen degrees
(16.degree.) plus or minus three degrees (.+-.3.degree.).
[0212] For some applications end 121 of trocar 120c may extend from
end 111c of cannula 110c with respective cutting surfaces 114 of
cannula 110g disposed adjacent to the end of each cutting surface
126 (short cutting surface) opposite from tip 123 of trocar 120c.
See FIG. 8E. As a result portions of each cutting surface 125 (long
cutting surface) of trocar 120c may be disposed within end 111 of
cannula 110c. See FIG. 8E.
[0213] Placing portions of cutting surfaces 125 within end 111 of
cannula 110c may result in more uniform forces being applied to end
101 of intraosseous device 100c while penetrating the cortex of an
associated bone using biopsy needle set 100c and a powered driver
in accordance with teachings of the present disclosure. When the
cortex has been penetrated, forces applied to end 101 of biopsy
needle set 100c may decrease sufficiently to indicate that end 101
has now entered associated bone marrow. An operator may then
withdraw trocar 120c from cannula 110c and position end 111c of
cannula 110c at a desired target area to perform a bone marrow
biopsy.
[0214] For some embodiments threads 190 and 190a may extend
approximately 0.005 inch from adjacent portions of an associated
longitudinal bore or lumen 118. The outside diameter of an
associated trocar such as trocar 120c as shown in FIG. 8E may be
reduced to accommodate the height of thread 190 or 190a. The
following test results were obtained during insertion of
intraosseous devices such as biopsy needle set 100c shown in FIG.
8E into sawbones material or blocks with three millimeters (3 mm)
of fifty pound (50#) and forty millimeters (40 mm) of forty pound
(40#) material.
TABLE-US-00001 Test # Motor Torque(g-cm) Time(s) 44 1101 2.23 45
1081 2.49 46 1071 2.36 47 1081 2.50 48 1030 2.46 49 1070 2.33
Average 1072 2.40
[0215] The distance between the end of cutting surface 126 or
trocar 120c and adjacent cutting surface 114 on cannula 110c was
approximately 0.14 inches. End 111 of cannula 110c had six (6)
ground cutting surfaces 114. The outside diameter of trocar 120c
was approximately 0.086 inches.
[0216] Coupler assemblies incorporating teachings of the present
disclosure may function as "quick release mechanisms" operable to
engage and disengage an IO device from a powered driver disposed
within a flexible containment bag or sterile sleeve. Such coupler
assemblies may allow rotation of an IO device without damage to the
flexible containment bag or sterile sleeve. For some applications
the IO device may be a vertebral IO needle or a biopsy needle. One
end of the coupler assembly may be operable to form a fluid seal or
fluid barrier with adjacent portions of the containment bag or
sterile sleeve. A coupler assembly incorporating teachings of the
present disclosure may be used in "non-sterile" environments and/or
medical procedures which do not require the use of a containment
bag or sterile sleeve.
[0217] Coupler assemblies incorporating various teachings of the
present disclosure may be placed in a medical procedure tray or kit
with one end down and an opposite end looking up to allow "hands
free" releasable engagement with a powered driver or a manual
driver. For example, coupler assembly 250 may be disposed in
medical procedure tray 20c with first end 251 insert into holders
58 and second end 252 looking up. See FIGS. 1C and 1D. As a result,
end 224 of drive shaft 222 extending from powered driver 200 may be
inserted into and releasably engaged with second end 252 of coupler
assembly 250 without requiring an operator or user (not expressly
shown) to physically contact or manipulate any portion of coupler
assembly 250. Various features of associated "hands free" latching
mechanisms are depicted in FIGS. 5A-5B.
[0218] As shown in FIGS. 5A-5D, coupler assembly 250 may include
elongated core 260 with housing assembly 270 slidably disposed on
exterior portions of elongated core 260. Housing assembly 270 may
include first end 271 and second end 272 which may be generally
aligned with respective first end 261 and respective second end 262
of elongated core 260. For some applications, elongated core 260
may have a generally cylindrical configuration defined in first
exterior portion 260a and second exterior portion 260b with various
shoulders and/or recesses formed thereon. For some embodiments
first exterior portion 260a may have a larger diameter than second
exterior portion 260b.
[0219] Coupler assembly 250a and coupler assembly 250b may include
respective elongated cores 260a and 260b having similar features
and functions as described with respect to coupler assembly 250.
Coupler assembly 250a may include housing assembly 270a with
substantially the same components, functions and features as
described with respect to housing assembly 270 except for second
end 272a of housing assembly 270a. Coupler assembly 250b may
include housing assembly 270b having substantially similar
components, functions and features as described with respect to
housing assembly 270 except for second end 272b of housing assembly
270b.
[0220] Housing assembly 270 may be described as having a generally
hollow, cylindrical configuration defined in part by first housing
segment 280 and second housing segment 290. See FIGS. 5A and 5B.
The first end of housing segment 280 may generally correspond with
first end 271 of housing assembly 270. The second end of second
housing segment 290 may generally correspond with second end 272 of
housing assembly 270.
[0221] First end 291 of second housing segment 290 may be described
as having a generally cylindrical configuration with an outside
diameter smaller than the adjacent inside diameter of second end
282 of first housing segment 280. First end 291 of second housing
segment 290 may slide longitudinally from a first position to a
second position within second end 282 of first housing segment 280
to release one end of a drive shaft engaged with second end 252 of
coupler assembly 250 (See FIGS. 5A-5D).
[0222] A biasing mechanism such as coiled spring 274 may be
disposed around exterior portion 260a of generally elongated core
260. See for example FIGS. 5A, 5B, 5C and 5D. First end 275 of
coiled spring 274 may contact annular shoulder 284 formed on
interior portions of first housing segment 280. Second end 276 of
coiled spring 274 may contact annular shoulder 278 disposed
proximate first end 291 of second housing segment 290. Coil spring
274, annular shoulder 284 and annular shoulder 278 may cooperate
with each other to generally maintain first housing segment 280 and
second housing segment 290 in a first extended position relative to
each other. See FIGS. 4A and 5A-5D. Other biasing mechanisms such
as, but not limited to, leaf springs and bellows (not expressly
shown) may also be disposed between annular shoulder 284 and
annular shoulder 278.
[0223] Annular shoulder 278, associated with second end 276 of
coiled spring 274, may extend radially outward from generally
cylindrical ring 277. Generally cylindrical ring 277 may be
slidably and rotatably disposed on exterior portion 260a of
elongated core 260. Annular shoulder 279 may be disposed on
interior portions of generally cylindrical ring 277 and may extend
radially inward toward adjacent portions of elongated core 260.
[0224] Annular shoulder 268 may be formed on exterior portion 260a
of elongated core 260 intermediate first end 261 and second end
262. The configuration and dimensions of annular shoulder 268 and
annular shoulder 279 are selected to be compatible with each other
such that engagement between annular shoulder 279 of generally
cylindrical ring 277 with annular shoulder 268 of elongated core
260 may limit movement of second housing segment 290 longitudinally
in the direction of second end 262 of elongated core 260.
[0225] For some applications a plurality of flexible collets or
fingers 477 may extend from generally cylindrical ring 277 opposite
from annular shoulder 278. Respective collet heads 478 may be
formed on the end of each collet 477 opposite from annular shoulder
278. The dimensions and configuration of collet heads 478 may be
selected to be received within respective slots or openings 297
formed in second housing 290. During manufacture of coupler
assembly 250, each collet head 478 may be disposed within
respective slot or opening 297 to securely engage generally
cylindrical ring 277 and annular shoulder 278 proximate first end
291 of second housing segment 290. As a result, second housing
segment 290 and annular shoulder 278 may generally move as a single
unit relative to elongated core 260 and first housing segment
280.
[0226] During disengagement of an intraosseous device from first
end 251 of coupler assembly 250, first housing segment 280 may move
or slide longitudinally toward second housing segment 290. In a
similar manner, second housing segment 290 may move or slide
longitudinally toward first housing segment 280 during
disengagement of a powered driver from second end 252 of coupler
assembly 250.
[0227] Annular shoulder 267 may be formed on exterior portions of
elongated core 260 proximate first end 261. Annular shoulder 267
may engage portions of first end 271 of housing 270 to limit
longitudinal movement of first housing segment 280 during
longitudinal movement of second housing segment 290 towards first
end 261 of elongated core 260 during disengagement of a powered
driver from second end 252 of coupler assembly 250.
[0228] As previously noted, annular shoulder 268 may be formed on
exterior portions of elongated core 260 between first end 261 and
second end 262. Engagement between annular shoulder 268 and annular
shoulder 279 of generally cylindrical ring 277 may limit movement
of second housing segment 290 toward second end 262 of elongated
core 260. Contact between spring 274 and annular shoulder 278 and
annular shoulder 284 of first housing segment 280 may limit the
longitudinal movement of first housing segment 280 in the direction
of second end 262 of elongated core 260 during disengagement of an
intraosseous device from first end 251 of coupler assembly 250.
[0229] Generally cylindrical ring 277 and attached annular shoulder
279 may slide longitudinally on exterior portions of annular core
260 between annual shoulder 268 and annular shoulder 267. First
housing segment 280 may move longitudinally toward second end 262
of elongated core 260 to release one end of intraosseous device
from engagement with first end 251 of coupler assembly 250. In a
similar manner, second housing segment 290 may move longitudinally
toward first end 261 of elongated core 260 to release one end of a
drive shaft extending from a powered driver engaged with second end
252 of coupler assembly 250.
[0230] A wide variety of latches and latch mechanisms may be
satisfactorily used to releasably engage one end of an intraosseous
device within a first end of a coupler assembly incorporating
teachings of the present disclosure. In a similar manner, a wide
variety of latches and latch mechanisms may be satisfactorily used
to releasably engage one end of a drive shaft extending from a
powered driver or manual driver within a second end of the coupler
assembly incorporating teachings of the present disclosure.
[0231] For embodiments represented by coupler assemblies 250, 250a
and 250b, first latch 410 may be disposed on exterior portions of
elongated core 260 proximate receptacle 263 adjacent to first end
261 to releasably engage one end of an IO device such as second end
102 of an IO needle set 100 within receptacle 263 of coupler
assembly 250, 250a and/or 250b. Second latch mechanism 420 may be
disposed on exterior portions of elongated core 260 proximate
receptacle 264 adjacent to second end 262 to releasably engage one
end of a drive shaft with second end 252 of coupler assembly 250.
See FIGS. 4A-4C and FIGS. 5A-5D.
[0232] Second latch 420 may be used to releasably engage one
portion of a drive shaft such as end 224 of drive shaft 222
extending from powered driver 200 within second end 252 of coupler
assembly 250, 250a and/or 250b. Latch 410 may releasably engage an
intraosseous device with first end 251 of coupler assembly 250
substantially the same latch 420 may releasably engage a powered
driver with second end 252 of coupler assembly 250.
[0233] For some applications, latches 410 and 420 may have similar
configurations such as a general "omega" shape. See latch 420 in
FIGS. 5C and 5D. However, latch 410 may have larger dimensions
corresponding generally with exterior portion 260a of elongated
core 260. Latch 420 may have smaller dimensions corresponding
generally with exterior portion 260b of elongated core 260. Various
features of the present disclosure may be described with respect to
latch mechanism 420 as shown in FIGS. 5C and 5D along with adjacent
portions of second housing segment 290 and exterior portion 260b of
elongated core 260.
[0234] Respective detents 421 and 422 may be formed on opposite
ends of generally omega shaped latch 420. See FIGS. 5C and 5D. In a
similar manner, respective detents (not expressly shown) may be
formed on the ends of generally omega shaped latch 410. The
configuration and dimensions of detents 421 and 422 may be
compatible with placing each detent 421 and 422 in respective slot
or opening 431 and 432 extending between exterior portion 260 b of
elongated core 260 to interior portions of receptacle 264 disposed
proximate second end 252 of coupler assembly 250.
[0235] Latch 420 may have a first position such as shown in FIGS.
5A-5D in which portions of detents 421 and 422 may extend through
respective slots 431 and 432. The dimensions and configuration of
detent 421 and 422 may be operable to be securely engaged with
annular groove 402 formed in end 224 of powered driver 200. In a
similar manner, respective detents on associated latch 410 may be
releasably engaged with annular groove 401 disposed in second end
102 of an IO needle 100.
[0236] For some applications, a plurality of tapered surfaces 403
may be formed on exterior portions of hub 140a proximate first end
142 (See FIG. 5A) to radially expand detent mechanisms associated
with omega shaped latch 410 radially outward while inserting second
end 102 of biopsy needle 100b into first end 251 of coupler
assembly 250, 250a or 250b. The detent mechanism may "snap" into
annular groove 401 when aligned therewith. In a similar manner, a
plurality of tapered surfaces 228 may be formed on exterior
portions of end 224 of drive shaft 222 extending from powered
driver 200 to radially expand detent mechanisms 421 and 422
radially outward during the insertion of end 224 of powered driver
200 into second end 252 of coupler assembly 250. Detent mechanisms
421 and 422 will "snap" into annular groove 402 when aligned
therewith. See FIG. 5A.
[0237] Engagement between detent mechanisms associated with latch
410 with annular groove 401 of hub assembly 130a will generally
retain second end 102 of biopsy needle 100b securely engaged with
first end 251 of coupler assembly 250. This engagement may allow
powered driver 200 to rotate or spin cannula or biopsy needle 110
while withdrawing cannula or biopsy needle 110 from an insertion
site. In a similar manner, engagement between detent mechanisms 421
and 422 of omega shaped latch 420 and annular groove 402 of end 224
of powered driver 200 will generally retain second end 252 of
coupler assembly 250 engaged with powered driver 100 during
withdrawal of cannula 110b from an insertion site.
[0238] IO needle set 100 may be released from first end 251 of
coupler assembly 250 by sliding first housing segment 280
longitudinally toward second end 262 of elongated core 260. Such
movement of first housing segment 280 will result in interior
tapered surface 286 contacting exterior portions of omega shaped
latch 410 and compressing omega shaped latch 410 to radially expand
associated detent mechanisms (not expressly shown) from engagement
with annular groove 401 of hub assembly 130a. As a result, IO
needle set 100 may be easily withdrawn from first end 251 of
coupler assembly 250.
[0239] In a similar manner, longitudinal movement of second housing
segment 290 toward first end 251 of coupler assembly 250 will
result in interior tapered surface 296 contacting exterior portions
of omega shaped latch 420 to compress generally omega shaped latch
420 and withdraw or retract detent mechanisms 421 and 422 from
engagement with annular groove 402 of end 224. See FIG. 5B. As a
result, powered driver 200 and second end 252 of coupler assembly
250 may be easily disconnected from each other.
[0240] Coupler assemblies 250 and 250a may have substantially the
same overall configuration and dimensions including respective
flange 254 extending radially from second end 252 and 252a. Flange
254 may be generally described as having an enlarged funnel shaped
or bell shaped configuration. The dimensions and configuration of
flange 254 may be selected to be compatible with end 211 of powered
driver 200. In some embodiments a coupler assembly 250b may not
have a respective flange 254 (not expressly shown). Second end 272b
of housing assembly 270b may terminate proximate first end 262 of
associated elongated core 260 and associated second end 252b of
coupler assembly 250b.
[0241] Further details about coupler assemblies and other latch
mechanisms and release mechanisms may be found in co-pending U.S.
patent application Ser. No. 11/853,678, filed on Sep. 11, 2007
entitled "Apparatus And Methods For Biopsy And Aspiration Of Bone
Marrow" (now U.S. Pat. No. 8,668,698).
[0242] FIG. 9 depicts an example of apparatus and methods which may
be used to insert a first end 111 of the generally hollow cannula
or IO needle 100 into the cortex of a bone and/or associated bone
marrow. Skin and soft tissue 302 generally cover insertion sites in
crest 304 of the bone. All bones generally include a tough, hard to
penetrate layer of cortex 306. FIG. 9 shows enlarged skin and soft
tissue layer 302 and cortex layer 306 for illustration purposes
only. A typical thickness for skin and soft tissue layer 302 may be
seven to eight millimeters (7 mm to 8 mm). A typical thickness for
cortex layer 306 may be approximately two millimeters (2 mm).
[0243] As previously discussed an intraosseous (IO) device or IO
needle set 100 may be inserted in the cortex of a bone with minimum
trauma to deliver a therapeutic medicament and/or obtain bone
and/or bone marrow samples in accordance with teachings of the
present disclosure.
[0244] The medical devices, medical procedure trays, kits and
diagnostic methods and therapeutic methods of the present
disclosure may be used to treat or evaluate any bone, such as but
not limited to, bones of the vertebrae, neck bones, sternum, rib,
clavicle, femoral, pelvic, wrist and the distal ends of the long
bones. Some exemplary conditions that may be diagnosed or treated
may include fractures, osteoporosis, degenerative bone diseases,
bone cancers, metastatic bone disease, osteolytic bone disease,
osteomalacia, osteitis fibrosa, Paget's disease, bone deficiency,
hyperparathyroidism. Fractures or degeneration of bone may result
from osteoporosis which may be age-related osteoporosis,
post-menopausal osteoporosis, juvenile osteoporosis, Cushing's
syndrome osteoporosis, multiple myeloma osteoporosis, leukemia
osteoporosis, Turner's syndrome osteoporosis, alcohol osteoporosis,
chronic liver disease osteoporosis, glucocorticoid-induced
osteoporosis, chronic inflammatory disease induced osteoporosis and
disuse osteoporosis.
[0245] FIGS. 10A-10D depict an exemplary medical procedure
performed on a vertebral disc of a human patient using the methods,
devices, medical procedure trays and kits of the disclosure. In a
non-limiting example, the vertebral procedure may be
vertebroplasty. The teachings of the present disclosure are however
not limited to vertebroplasty or vertebral procedures and
medicaments or therapeutic agents of any type may be delivered to a
vertebral bone (or any other bone) and/or a biological sample may
be obtained for analysis during the same procedure.
[0246] In an example vertebroplasty procedure, depicted in FIGS.
10A-10D, an operator may obtain a medical procedures tray 20
comprising a vertebral IO device as set forth in the present
disclosure, comprising a vertebral IO needle system/set 100, power
driver 200, coupler assembly 250 comprising sterile sleeve 170. An
example vertebral IO device may comprise a vertebroplasty needle
set and may include a beveled needle comprising a cannula 100a and
a stylet with a beveled cutting tip and a serrated cutting edge
(see FIGS. 7B and 7F). The IO device may also comprise a biopsy
needle set, and may comprise a cannula 100d with a helical thread
192 for capturing a bone sample (see FIGS. 8A and 8B). The coupler
assembly 250 may be operable to releasably attach different
vertebral IO needles 100 at end 251 and releasably attach power
driver 200 at end 252.
[0247] The operator may assemble the vertebral system apparatus by
unwrapping a sterile medical procedure tray and attaching a
non-sterile power driver 200 to end 252 of the coupler assembly 250
and covering power driver 250 with sterile glove 170 as shown in
FIGS. 3A and 3B. Sterile vertebral needle 100a may be then attached
to end 251 of the coupler 250 as shown in FIG. 3C. The sterile
vertebral needle 100a attached to the vertebral apparatus as in
FIG. 3C may then be inserted into a vertebral disc "powered in."
Generally, an operator trained to perform such a procedure, may
insert a vertebral needle 100 through the cortex 306 of a vertebral
bone into the vertebral body 307 using powered drill 200 under the
guidance of fluoroscopy or other visual imaging methods. Following
powering in, driver 200 may be released from the coupler 250 and
the stylet comprising a beveled cutting tip and/or a serrated
cutting surface and/or any other suitable cutting tip may be
withdrawn from the cannula 100 of the vertebral needle, thereby
leaving the cannula 100 firmly seated in the vertebral body 307
(see FIG. 10B).
[0248] A trocar, and/or needle, and/or ejector rod, and/or syringe
filled with a bone cement 309 (and/or other medicaments) may be
slidably disposed into cannula 100a as shown in FIG. 10C
(trocar/needle/rod/syringe 100b not expressly shown) and bone
cement 309 may be injected into the vertebral body 307. A
connection (such as a Luer lock) may be used to attach 100b with
100a. The trocar 100b may comprise one or more therapeutic agents
to be delivered into a bone such as a vertebral disc. For example,
a bone strengthening agent/factor may be delivered with the bone
cement. In some embodiments, the bone cement or therapeutic agent
may be delivered directly through the cannula 100a into the
vertebral body (without requiring trocar 100b). The injected bone
cement will typically solidify and strengthen a fractured and/or
compressed vertebra.
[0249] Either preceding or following injection of the bone cement
309 into the vertebral body 307, a biopsy needle 100d comprising
handle 96, first end 91 and second end 92 may be inserted into
cannula 100 and used to obtain a specimen of bone tissue for
diagnostic analysis (see FIG. 10D). The biopsy needle 100d may then
be withdrawn, power driver 200 reattached to coupler assembly 250
at end 251 and the cannula 100 may be withdrawn from the patient
"powered out" (not expressly shown). Thus, a therapeutic procedure
may be combined with a diagnostic procedure using the IO needles,
IO devices, methods, kits and trays of the present disclosure.
[0250] Following the medical and/or diagnostic procedures, the
driver 200 may be detached from the coupler assembly and cleaned
and stored for further use. A non-sterile power driver 200 may be
used with disposable needles 100 and a disposable coupler 250,
comprising a sterile sleeve 170, thereby allowing multiple use of
the non-sterile power driver.
[0251] As described above, for delivery of a therapeutic agent to
bone and/or for removal of a biological specimen from a bone the
needles 100b or 100d as depicted in FIGS. 10A-10D may also be
referred to as an "ejector rod". An ejector rod, such as 100b or
100d, may be slidably disposed into a hollow cannula 100a of an IO
needle to deliver a medicament or obtain a biological sample from a
bone.
[0252] The length of ejector 100b or 100d may be selected to be
greater than the length of a lumen in an associated IO needle 100a.
Handle or hub 96 may be disposed on second end 92 of ejector 100b
or 100d. The dimensions and configuration of first end 91 of
ejector rod 100b or 100d may be selected to be compatible with
inserting first end 91 through an opening in the first end of an
associated IO needle 100a. As set forth above, the teachings of the
present disclosure are not limited to vertebroplasty or vertebral
procedures and medical procedures for delivery of a therapeutic
agent and possibly combining such a therapeutic procedure with a
diagnostic procedure are provided by this disclosure for any bone
and any bone related condition.
[0253] Benefits of the present disclosure may include reducing
physical requirements and mental stress on operators and decreasing
pain and stress on patients by increasing speed and control of the
needle set insertion during vertebral procedures or other bone
procedures and by decreasing the number of procedures performed and
the number of times a bone is drilled into.
[0254] Although the present disclosure and its advantages have been
described in detail, it should be understood that various changes,
substitutions and alternations can be made herein without departing
from the spirit and scope of the invention as defined by the
following claims.
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