U.S. patent application number 11/927729 was filed with the patent office on 2008-03-06 for imaging method, device and system.
Invention is credited to Daniel A. Shimko.
Application Number | 20080058641 11/927729 |
Document ID | / |
Family ID | 37983894 |
Filed Date | 2008-03-06 |
United States Patent
Application |
20080058641 |
Kind Code |
A1 |
Shimko; Daniel A. |
March 6, 2008 |
IMAGING METHOD, DEVICE AND SYSTEM
Abstract
A method, device and system or kit treat a lesion by injecting a
contrasting agent into a body area to distinguish an osteolytic
lesion for imaging; and delivering an effective amount of a
debridement fluid to debride the distinguished lesion.
Inventors: |
Shimko; Daniel A.;
(Collierville, TN) |
Correspondence
Address: |
PHILIP D FREEDMAN PC;PHILIP D FREEDMAN
317 S. FAYETTE STREET
ALEXANDRIA
VA
22314-5902
US
|
Family ID: |
37983894 |
Appl. No.: |
11/927729 |
Filed: |
October 30, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11295639 |
Dec 7, 2005 |
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11927729 |
Oct 30, 2007 |
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Current U.S.
Class: |
600/433 ;
604/35 |
Current CPC
Class: |
A61B 6/487 20130101;
A61B 50/30 20160201; A61B 6/481 20130101; A61B 2090/376 20160201;
A61M 5/007 20130101; A61F 2/3859 20130101; A61F 2/389 20130101;
A61F 2002/30878 20130101; A61F 2/0095 20130101; A61F 2002/30787
20130101; A61F 2002/488 20130101; A61F 2002/30158 20130101; A61B
2090/3933 20160201; A61F 2002/30785 20130101; A61F 2002/2839
20130101; A61B 17/1604 20130101; A61F 2002/30759 20130101; A61B
17/32037 20130101; A61B 6/4441 20130101; A61B 90/36 20160201; A61F
2/30756 20130101; A61F 2002/3401 20130101; A61F 2002/30673
20130101; A61F 2/34 20130101 |
Class at
Publication: |
600/433 ;
604/035 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61M 1/00 20060101 A61M001/00 |
Claims
1. to 30. (canceled)
31. A method of imaging an osteolytic lesion, comprising: injecting
a contrast agent into synovial fluid in a vicinity of the
osteolytic lesion; permitting contrast agent injected synovial
fluid to circulate to the lesion; positioning an imaging device
responsive to the contrast agent adjacent the vicinity of the
osteolytic lesion; and imaging the osteolytic lesion distinguished
by the contrast agent from adjacent tissue.
32. The method of claim 31, wherein the osteolytic lesion is
fluoroscopically imaged and a location and orientation of a
debridement delivery device is adjusted according to location or
extent of the fluoroscopic image.
33. The method of claim 31, wherein the vicinity is a knee or hip
joint space.
34. The method of claim 31, wherein injecting the contrast agent
comprises: positioning an injection catheter into the vicinity of
the osteoloytic lesion; and injecting the contrast agent into
synovial fluid in the vicinity through the injection catheter.
35. The method of claim 31, further comprising effecting
debridement of the distinguished lesion by a pulse lavage
process.
36. The method of claim 31, further comprising: emitting x-rays
from the imaging device toward the distinguished lesion, detecting
x-rays that have traversed the lesion, constructing a tomographic
image from signals that are responsive to the detected x-rays to
generate a real-time fluoroscopic image on a display monitor
depicting the distinguished lesion and the relationship of a
delivery/aspirator end of a debridement device to the area; and
adjusting the location and orientation of the delivery/aspirator
end of the debridement device according to the display monitor
image to debride the lesion.
37. The method of claim 31, further comprising delivering an
effective amount of a debridement fluid to debride the
distinguished lesion.
38. The method of claim 31, comprising injecting the contrast agent
into synovial fluid in the body area that is in fluid communication
with the osteolytic lesion, wherein the contrast agent migrates to
the lesion by flow or diffusion.
39. The method of claim 31, comprising injecting the contrast agent
into synovial fluid in the body area that is in fluid communication
with the osteolytic lesion, wherein the contrast agent migrates to
the lesion by flow or diffusion; and imaging a location or extent
of a lesion in the area that has been distinguished by the
contrasting agent.
40. The method of claim 31, comprising injecting the contrast agent
into synovial fluid in the body area that is in fluid communication
with the osteolytic lesion, wherein the contrast agent migrates to
the lesion by flow or diffusion; imaging a location or extent of a
lesion in the area that has been distinguished by the contrasting
agent; and controlling debridement of the osteolytic lesion
according to the imaging.
41. The method of claim 31, comprising injecting the contrast agent
into synovial fluid in the body area that is in fluid communication
with the osteolytic lesion, wherein the contrast agent migrates to
the lesion by flow or diffusion; imaging a location or extent of a
lesion in the area that has been distinguished by the contrasting
agent; and controlling debridement of the osteolytic lesion
according to the imaging; wherein the debridement comprises
delivering a debridement fluid and intermittently aspirating the
fluid by pulse lavage.
42. The method of claim 31, comprising injecting the contrast agent
into synovial fluid in the body area that is in fluid communication
with the osteolytic lesion, wherein the contrast agent migrates to
the lesion by flow or diffusion; imaging a location or extent of a
lesion in the area that has been distinguished by the contrasting
agent; and controlling debridement of the osteolytic lesion
according to the imaging; wherein the debridement comprises
delivering of a fluid with suspended particulate abrasive and the
delivering is adjusted according to the imaging to direct the fluid
with suspended particulate to the lesion area.
43. The method of claim 31, further comprising: emitting x-rays
toward the lesion area, detecting x-rays that have traversed the
lesion area, constructing a real-time fluoroscopic image of
delivering fluid and the lesion area from signals that are
responsive to the detected x-rays; adjusting the delivering of the
debridement fluid according to the fluoroscopic image to debride to
lesion.
44. The method of claim 31, wherein the contrast agent comprises a
biosorbable material that is capable of being detected or monitored
by fluoroscopy, x-ray photography, CAT scan or ultrasound.
45. The method of claim 31, wherein the contrast agent comprises a
biosorbable material that is capable of being detected or monitored
by fluoroscopy, x-ray photography, CAT scan or ultrasound suspended
or dissolved in a carrying fluid.
46. A debridement system, comprising: a fluid reservoir for a
debridement fluid containing a contrast agent; a delivery section
comprising; an expression cannula connected to the reservoir and an
aspirator cannula concentric to the expression cannula; and an
imaging device responsive to contrast agent injected from the
reservoir by the delivery section.
47. The system of claim 47, wherein the delivery section comprises
a tubular conduit having a pickup end and delivery/aspirator end
and first and second cannulas extending with one another
longitudinally as part of the tubular conduit; the first cannula
having at least one orifice at the delivery/aspirator end of the
tubular conduit to deliver or aspirate debridement fluid to or from
the distinguished lesion; and the second cannula substantially open
at the delivery/aspirator end of the tubular conduit to deliver or
aspirate fluid to or from the distinguished lesion.
48. The system of claim 46, wherein the imaging device comprises a
fluoroscopy imaging device that includes an x-ray source oriented
to emit x-rays toward the lesion area; a radiation detector that
detects x-rays from the source that have traversed the lesion area;
an image display to generate a real-time fluoroscopic image showing
the relationship of the delivery/aspirator end of the tubular
conduit to the area on a display monitor from signals that are
responsive to the detected x-rays.
49. The system of claim 46, wherein the contrast agent comprises a
biosorbable material suspended or dissolved in a carrying
fluid.
50. The system of claim 46, wherein the contrast agent comprises a
biosorbable material that is capable of being detected or monitored
by fluoroscopy, x-ray photography, CAT scan or ultrasound.
Description
BACKGROUND OF THE INVENTION
[0001] The invention relates generally to medical imaging and
particularly to highlighting an osteolytic lesion and debridement
of an imaged highlighted lesion. In an aspect, the invention
relates to a method, device and kit for distinguishing and imaging
a lesion for debridement.
[0002] Osteolysis is a common complication in total hip
arthroplasty and the most common cause of component failure.
Osteolysis is a response to wear debris. It can develop around a
hip or knee implant as a result of generation of wear debris,
access of the particles to the implant-bone interface and the
biologic response of the implant host to the particles. Osteolysis
is mediated primary by macrophages. Fibroblasts and endothelial
cells also play a role. These cells are activated by the wear
debris, primarily polyethylene, but also metal and
polymethylmethacrylate particles. The biologic reaction to these
particles is a nonspecific foreign-body reaction. Particles in the
submicron size range undergo phagocytosis by macrophages and
release a variety of cytokines which ultimately stimulate
osteoclasts to resorb bone. The most common source of wear debris
is adhesive-abrasive wear between a femoral head and polyethylene
liner. This wear can produce as many as 500,000 particles per gait
cycle.
[0003] Osteolysis can be asymptomatic until the lesions become very
large. While some osteolytic lesions may be cleansed by washing and
conventional debridement, surgery is a typical treatment. The
surgery both treats the lesions and removes particles that could
generate recurrence. With a stable acetabular component in
acceptable alignment and with a modular liner, debridement and bone
grafting of the lesions with retention of the acetabular shell and
replacement of the polyethylene liner can be successful. However,
if the acetabular shell is loose or malpositioned, then revision of
the component is indicated.
[0004] While washing and debridement procedures are preferred
approaches to lesion management, these less invasive procedures are
not always available. First, osteolytic lesions are not easily
diagnosed because they can be hidden well within tissue near an
implant. They can be hidden from x-tray visualization because they
are near obscuring metal implant structure or the like. Or, simply
the lesions are not sufficiently distinguished from adjacent tissue
and structure to be visualized by usual detection mechanisms such
as fluoroscopy. Successful substantially noninvasive treatment of
osteolytic lesions requires that the lesion location including
location and extent in an implant area be identified and imaged
during debridement. Currently there are few strategies for reliably
noninvasively locating and identifying lesions for debridement.
There is a need for a method, device and system or kit for
diagnosing osteolytic lesions and for visualizing the location and
extent of an osteolytic lesion.
BRIEF DESCRIPTION OF THE INVENTION
[0005] The invention provides a method and kit for substantially
noninvasively diagnosing an osteolytic lesion and a method and kit
for distinguishing the location or extent of an osteolytic lesion
for substantially noninvasively debridement of the lesion.
According to the invention, a method for treatment of a lesion
comprises: injecting a contrast agent into a body area to
distinguish an osteolytic lesion for imaging; and delivering an
effective amount of a debridement fluid to debride the
distinguished lesion.
[0006] A system or kit for treatment of a lesion comprises: a
delivery device for injecting a contrast agent into a body area to
distinguish an osteolytic lesion for imaging; a fluid reservoir, a
debridement fluid contained within the fluid reservoir; a tubular
conduit having a pickup end and delivery/aspirator end and first
and second cannulas extending with one another longitudinally as
part of the tubular conduit; the first cannula having at least one
orifice at the delivery/aspirator end of the tubular conduit to
deliver or aspirate debridement fluid to or from the distinguished
lesion; and the second cannula substantially open at the
delivery/aspirator end of the tubular conduit to deliver or
aspirate fluid to or from the distinguished lesion; and an imaging
device to monitor delivery of the debridement fluid to the
distinguished lesion.
[0007] In another embodiment, a diagnostic procedure comprises:
injecting a contrast agent into synovial fluid in a body area in
need of treatment; and imaging a location or extent of a lesion in
the area that has been distinguished by the contrast agent.
[0008] In still another embodiment, a method of imaging an
osteolytic lesion comprises injecting a contrast agent into
synovial fluid in a vicinity of the osteolytic lesion; permitting
contrast agent injected synovial fluid to circulate to the lesion;
positioning an imaging device responsive to the contrast agent
adjacent the vicinity of the osteolytic lesion; and imaging the
osteolytic lesion distinguished by the contrast agent from adjacent
tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1 through 4 are schematic representations of
osteolytic lesion areas nearby hip and knee implants;
[0010] FIG. 5 is a schematic elevation of a lesion debridement
device;
[0011] FIG. 6 is a cross-sectional side view of a tubular flexible
delivery tube end of the FIG. 5 device;
[0012] FIG. 7 is a schematic side elevation of a pulse-generating
mechanism for the debridement device;
[0013] FIG. 8 is a schematic perspective view of a user using a
system or kit including a lesion debridement device and monitoring
fluoroscope; and
[0014] FIG. 9 shows the hip joint of FIG. 1 in need of treatment
for a lesion and placement of a debridement device to effect
irrigation of the lesion
DETAILED DESCRIPTION OF THE INVENTION
[0015] The invention relates to a method that injects a contrast
agent, preferably water miscible, into a contained normal anatomic
cavity of the body in the vicinity of an implant. In a preferred
embodiment, a contrast agent is injected into synovial fluid at a
joint. Synovial fluid is a clear, thixotropic lubricating fluid
secreted by membranes in joint cavities, tendon sheaths, and
bursae. The injected fluid carries a contrast agent that renders a
lesion radio-opaque or identifiable to available non-invasive
imaging technology. The injected material can distribute evenly
within the cavity space by way of diffusion. The distribution can
be enhanced by external ultrasound application, or mechanical
motion of the cavity space. For example, after injection into a
knee, a patient can be asked to walk a number of paces to help
distribute the injected material.
[0016] In the case of a knee or hip replacement, lesions can form
behind or around the implanted medical device. These lesions
otherwise may be undetectable by conventional non-invasive imaging
techniques. The injected contrast agent distributes within the
fluid cavity. If a lesion communicates with the cavity, the
material will also distribute to the previously un-identified
lesion. The inventive method identifies a lesion that communicates
with the fluid filled anatomic cavity, either by natural flow of
the fluid around an implanted device or natural structure or
through emplaced voids in a device such as the holes in an
implanted cup. For example, osteolytic lesions can communicate with
the normal anatomic synovial joint space either around an implant
or through holes in a hip implant. According to the invention, the
synovial fluid is injected with a contrast agent, which then flows
to the lesion and distinguishes to make it identifiable by
non-invasive imaging. The agent can identify the lesion location
and extent to permit debridement.
[0017] Debridement can be by any suitable procedure for wound or
lesion management including lavage, particularly pulse lavage or
pulse irrigation is one. In pulse lavage, a pulsating water jet, is
directed toward the wound or lesion area. This procedure is
effective in removing debris and bacteria from wound and lesion
areas. Pulse irrigation is used as part of a number of orthopedic
procedures such as prosthetic joint replacement, in which it is
used to remove bone fragments from an area of prosthesis.
[0018] The debridement fluid of the invention can be water and
other aqueous compositions, including any other typical irrigating
or debridement solution. Preferably the fluid is a clear
biocompatible debridement fluid such as warm isotonic saline or
normal saline in combination with an antibiotic. However, many
variations are possible. The solution may include buffers and a
bicarbonate, citric acid and tanic acid in very low concentrations.
Or the fluid can be a gas and liquid mixture. The gas can be oxygen
or carbon dioxide or hydrogen peroxide useful for sterilization
purposes. The fluid can include steroid and anti-inflammatory
mendicants.
[0019] A preferred debridement fluid comprises a mixture of
inorganic salts and minerals, compounded to mimic an electrolyte
concentration and a body fluid mixture in an isotonic state. The
fluid typically comprises a halide salt of lithium, sodium,
potassium, calcium, and other cations. Typically the halide is
fluoride, chloride, bromide, or iodide, and most typically
chloride. A typical electrolyzed solution has a pH within the range
of about 2 to about 5, an oxidation reduction potential within the
range of about +600 mV to about +1200 mV, and hypohalous acid
concentration in the range of about 10 ppm to about 200 ppm. The
solution can have bactericidal, fungicidal, and sporicidal
properties.
[0020] In this specification, "biosorbable" means capable of being
harmlessly taken up by the body and "biocompatible" means capable
of harmlessly persisting in the body. The term "biocompatible"
includes biosorbable materials. The debridement fluid of the
invention can include a biocompatible particulate abrasive, which
can be a biosorbable material that dissolves within several days.
Preferably, the abrasive is biosorbable and capable of passing
through small gauge needles under lavage pressure. Calcium sulfate
(CaSO.sub.4) is a preferred material and may be obtained as
MIIG.TM. from Wright Medical Technology, Inc. of Arlington, Tenn.
The particulate abrasive can be present in the debridement fluid in
a percent by weight between 0.1 and 65; desirably between 1 and 40
and preferably between 3 and 15. Other possible particulate
abrasives include the materials disclosed in copending application,
Shimko et al., (attorney docket P23148). For example, these include
injectable forms of: calcium phosphate, tri-calcium phosphate,
hydroxyapatite, coral hydroxyapatite, demineralized bone matrix,
and mineralized bone matrix. Further, the biosorbable material can
be an injectable solid form of a biopolymer, for example,
polylactic acid, polyglycolic acid, polygalactic acid,
polycaprolactone, polyethylene oxide, polypropylene oxide,
polysulfone, polyethylene, polypropylene, hyaluronic acid or
bioglass.
[0021] An embodiment of the invention comprises following progress
of the lesion debridement by fluoroscopy. In this embodiment,
contrast agent is injected into the lesion area through a catheter,
or preferably through the inner expression cannula of the device of
the invention along with debridement fluid. The contrast agent
migrates so that the lesion can be radiographically imaged with a
fluoroscope. The fluoroscope produces a planar (or two dimensional)
image of the lesion area that can be evaluated to monitor the
debridement method. This embodiment is discussed in further detail
in conjunction with the drawings.
[0022] These and other features of the invention will become
apparent from the drawings and following detailed discussion, which
by way of example without limitation describe preferred embodiments
of the invention.
[0023] FIG. 1 and FIG. 2 are views of a hip joint implant and FIG.
3 and FIG. 4 are respectively a tibia implant and a femur implant.
These figures illustrate the difficulty of diagnosing an osteolytic
lesion and determining its location and orientation, particularly
when in proximity to a metal implant as shown in FIG. 4. In these
figures, like structures are identified by the same part
number.
[0024] FIG. 1 and FIG. 2 are anterior to posterior views of pelvis
212, FIG. 3 is an anterior to posterior view of a knee implant into
tibia 214 and FIG. 4 is a medial to lateral view of an implant into
femur 216. FIG. 1 and FIG. 2 how osteolytic lesions 218, 220 buried
deep within the pelvis 212 behind acetabular cup 122 of implant
224. The acetabular cup 222 is also shown in detail in FIG. 1. In
FIG. 2, synovial fluid 228 within joint capsule 230 is in fluid
communication with the lesion 220 around the cup 222. In FIG. 1,
the lesion 218 is completely buried behind the acetabular cup 222.
However, the fluid 228 is in communication with the lesion 220
through holes 226 in the cup 222. Injector 232, which can be a
syringe or other slender non-invasive delivery instrument is shown
injected into the synovial fluid cavity 234 in each of the FIG. 1
and FIG. 2.
[0025] In operation, a contrast agent is injected into the synovial
fluid 228 by the injector 232. The contrast agent is delivered as a
dissolved or suspended fluid that in turn is either dissolved or
suspended in the synovial fluid 228 and is transported by the fluid
228 to the lesion 218, 220 site where it radio-opaquely contrasts
the lesion 218, 220.
[0026] FIG. 3 and FIG. 4 illustrate other lesion locations that can
be identified and controllably treated according to the invention.
FIG. 3 is an anterior to posterior view of tibia 214 with implant
242 with screw holes 244 and upper polyethylene articular surface
246. Lesion 248 has formed beneath the implant, substantially
removed from view of any imaging technique. A contrast agent is
injected by injector 232 into synovial fluid 228 above the
polyethylene articular surface 246. The contrast agent migrates
with the fluid 228 through screw holes 244 and around the implant
to the location of the lesion 248. The lesion is stained for
identification, again as described hereinafter with reference to
FIGS. 5 through 9.
[0027] In FIG. 4, femur 216 is shows a particularly pernicious
lesion 252. The lesion 252 is situated within an outline of metal
femur implant component 254 and is unobservable by any imaging
technique. In this case, the contrast agent is injected by injector
232 into synovial fluid 228, and then migrates to the lesion 252
with flow of the fluid 228 around the implant component 254 to
highlight the lesion 252.
[0028] The contrasted lesions 218, 220, 248 and 252 are amenable to
imaging diagnoses and fluoroscopic controlled debridement as
described hereinafter with reference to FIGS. 5 through 9.
[0029] The contrast agent is a biocompatible material that is
capable of being detected or monitored by fluoroscopy, x-ray
photography, CAT scan, ultrasound or other such imaging techniques
that can be used to detect and locate contrast distinguished
tissue. The invention may be used as a diagnostic tool to identify
and define previously unknown or undetected hard or soft orthopedic
and skeletal lesions that communicate with normally occurring fluid
filled anatomic spaces in the body, such as the synovial capsule
surrounding articulating joints.
[0030] The contrast agent is suspended or dissolved into a carrying
fluid and is injected into the vicinity of a joint implant with
suspected osteolytic lesions. Preferred contrast agents are
radio-opaque materials. The contrast agent can be either water
soluble or water insoluble. Examples of water soluble contrast
agents include metrizamide, iopamidol, iothalamate sodium, iodomide
sodium, iohexol and meglumine. Examples of water insoluble contrast
agents include tantalum, tantalum oxide, and barium sulfate, each
of which is commercially available. Other water insoluble contrast
agents include gold, tungsten, and platinum powders. Some
radio-opaque contrasting agents are available in liquid form. These
include, for example, OMNIPAQUE from Nycomed, Inc., Princeton, N.J.
Preferably, the contrast agent is water insoluble (i.e., has a
water solubility of less than 0.01 mg/ml at 20.degree. C.).
[0031] The carrying fluid for the contrast agent can be water or
other aqueous compositions. Preferably the fluid is a clear
biocompatible fluid such as warm isotonic saline or normal saline.
However, many variations are possible. The solution may include
materials such as an antibiotic, a buffer or a bicarbonate, citric
acid and tanic acid in very low concentrations.
[0032] As with the debridement fluid, a preferred carrying fluid
comprises a mixture of inorganic salts and minerals, compounded to
mimic an electrolyte concentration and a body fluid mixture in an
isotonic state. The fluid typically comprises a halide salt of
lithium, sodium, potassium, calcium, and other cations. Typically
the halide is fluoride, chloride, bromide, or iodide, and most
typically chloride. A typical electrolyzed solution has a pH within
the range of about 2 to about 5, an oxidation reduction potential
within the range of about +600 mV to about +1200 mV, and hypohalous
acid concentration in the range of about 10 ppm to about 200 ppm.
The solution can have bactericidal, fungicidal, and sporicidal
properties.
[0033] The contrast agent can be dissolved or suspended in the
carrying fluid in a weight percent from 0.001 mg/ml to 1000 mg/ml,
desirably 0.01 mg/ml to 800 mg/ml, and preferably 0.1 mg/ml to 600
mg/ml.
[0034] FIG. 5 shows a debridement device 10 for the washing and
debridement of wounds and lesions of a patient. The system 10
includes housing 12 with conduit 14 for the delivery of fluid under
pressure. With reference to FIGS. 1 and 2, inner expression cannula
18 and outer aspirator circumferential cannula 20 are shown
longitudinally form the conduit 14. The conduit 14 includes a
flexible pickup section 22 and a rigid delivery section 24. The
system 10 includes a pressurized fluid reservoir 40 and a fluid
transfer pump 50, which is in fluid communication with inner
expression cannula 18 and outer aspirator cannula line 20.
[0035] The conduit 14 has a pickup end 16 at fluid reservoir 50 to
operatively connect the inner cannula 18 from the reservoir 40
(through fluid transfer pump 50) to fluid aspirator/expression end
26 of rigid section 24. The outer aspirator cannula 20 is
operatively connected from the fluid transfer pump 50 to fluid
delivery/aspirator end 23 to fluid aspirator/discharge end 26 of
rigid section 24. In this example, the fluid within the reservoir
40 is a saline solution. The saline solution comprises 10 weight
percent suspended calcium sulfate particulate having a particle
size of about 150 microns.
[0036] Fluid transfer pump 50 includes a drivable motor 52 having
an elongated rotor shaft 54. A fluid pressure generating pump 58 is
arranged at a first end 56 of the rotor shaft 54. The pump 58
provides fluid pressure to the dual cannula flexible tube 22 from
reservoir 40. A second end 60 of rotatable shaft 54 is attached to
a suction pump 62, also located within the housing 12. Suction pump
is in fluid communication with a screened disposable collection
bottle 34 to provide a vacuum incentive of drainage of fluids to
the bag 34. In this embodiment, a common empowered motor 52 with an
extended shaft 54 provides drive for both pressure pump 58 and
vacuum source 62. The arrangement provides for a dual continuous
pulsed feed of fluid to a patient lesion area shown in FIGS. 1
through 4 for a continuous withdrawal of fluid from the area after
treatment of a wound or lesion.
[0037] FIG. 6 is a cut away depiction of rigid delivery section 24
of the conduit 14 including inner cannula 18 and outer cannula 20.
Inner cannula 18 provides a passageway for fluid from fluid
reservoir 40. The fluid is expressed from syringe end 70 of the
inner cannula 18 to a wound or lesion area. An outer wall 30 of
conduit 14 forms outer cannula 20 with wall 26 of inner cannula 18
to provide a fluid passageway for aspirating fluid from wound or
lesion area after lavage treatment.
[0038] In an embodiment shown in FIG. 7, pulsating pump 84 has a
rotating wheel 88 arranged to spin within sinusoidal inner surface
90. The sinusoidal operation of the wheel 88 intermittently
squeezes and releases flexible fluid feedline 92. Feedline 92
includes pickup end 16 at fluid source 40 (shown in FIG. 5). A
fluid feed section 96 extends to form inner expression cannula 18,
shown in FIG. 6. Rotation of wheel 88 within the sinusoidal surface
90 generates intermittent pulses that are discharged through the
pressured inner expression cannula 18 to be expressed at syringe
end 70. In an embodiment, the suction side of the fluid transfer
pump 50 is effected in a pulsed manner similar to the fluid
pressure side. The suction or vacuum side 62 of the pump 50 can be
in-phase or out-of-phase with the fluid pressure pulsating pump
58.
[0039] FIG. 9 shows the same pelvis 212 in need of treatment for a
lesion 218 as described with reference to FIG. 1. Additionally,
FIG. 9 shows placement of aspirator/expression end 26 of the
debridement device 10 to effect irrigation of the lesion 218.
Further, FIG. 8 illustrates fluoroscopic monitoring of the
debridement.
[0040] First, referring to FIG. 8, a user 112 is shown using a
system or kit (delineated by dashed outline 110) including a
support member 114 supporting a monitoring fluoroscope 116, an
image display 118 such as a flat panel television monitor and a
lesion debridement device 10. The user 112 grasps the rigid
delivery section 24 of the debridement device 10 and inserts it
into a hip joint 124. Shown interiorly in FIG. 5, of a patient (the
patient's outline beneath a sheet is indicated at 126).
[0041] FIG. 9 shows a hip implant 224 that has been surgically
implanted into the pelvis 212. The implant 2324 may be of any form;
for example, fixed, modular, primary, revision, ceramic head or
metal head. In non-diseased portions of pelvis 212, implant 224 is
well-fixed but in a diseased portion, osteolytic lesion 218 takes
up space that would normally be filled with cancellous bone. Lesion
218 is soft and spongy. Though lesion 218 is depicted in this
embodiment as being in the hip above acetabular cup 222, it could
be in the area of the implant 224.
[0042] Typical treatment to debride the lesion 218 is significant
and invasive, sometimes involving removal of the implant 224, open
debridement of the lesion 218 (which enlarges the intramedullary
area even further), and implantation of a revision implant. In
another typical treatment, location of the lesion 218 is identified
by fluoroscope or other imaging process, first and second holes are
bored to access the lesion area and lavage fluid is expressed
through one hole and is suctioned out the second hold. This
procedure operates blindly without assurance that fluid expressed
through the first hole delivers lavage to the lesion area.
Additionally, the lesion can be tough and resistant to a typical
fluid that would be used in the first and second hole
procedure.
[0043] The present invention provides a minimally-invasive and
accurate approach to treating lesions without removal of implants
and revision and without two hole bodily invasion. The invention
accurately delivers lavage to assure complete debridement of the
lesion. In the present invention, a lavage fluid is utilized that
comprises abrasive particles that completely debride even an
osteolytic lesion that may be filled with resistant gelatinous
masses of nacrotic and fibrous tissue. Additionally, in an
embodiment of the invention, insertion of the rigid delivery
section 24 of the debridement device into the hip joint, the
orientation of the syringe expressing end 70 of the delivery
section 24; impingement of expressed debridement fluid the lesion
and aspirating of fluid containing the nacroic and fibrous tissue
and spent fluid and particles can be monitored to assure complete
debridement.
[0044] The lesion debridement is monitored in FIG. 8 by viewing a
fluoroscopic image of the hip joint 124, lesion area 136, and
inserted rigid delivery section 14. The patient 126 resides on
table 120, which is essentially transparent to x-rays. A support
member 122 supports a fluoroscope and a television monitor 118. The
fluoroscope 116 can be supported by a C-shaped arm 142 device, as
shown, Table 120 and patient 126 are positioned within the C formed
by arm 142. Fluoroscope 116 is an x-ray tube unit at a lower end of
the C-shaped arm. The x-ray tube unit 116 emits an x-ray beam in a
generally upward vertical direction through a diaphragm 146. The
x-ray beam is directed upward through the table 120 and the hip
joint 124 of patient 126. The x-ray beam is received by image
intensifier 148, which includes a television camera (not shown). A
fluoroscopic field of view received by the camera at image
intensifier 148 is projected on television monitor 118.
[0045] In operation, patient 126 is aligned between tube unit 116
and image intensifier 148 so that the internal patient's hip joint
124 is visible on television monitor 116. User 112 performs a
puncture of the patient's hip area toward the joint 124 with the
elongated rigid delivery section 24 of debridement device 10. The
user 112 positions the puncture so that the inserted delivery
section 24 syringe end is generally perpendicular to a central axis
of an x-ray beam, which is directed upward from fluoroscope x-ray
tube unit 116 to image intensifier 148. The fluoroscopic field of
view of fluoroscope 116 is then narrowed to display an image on
monitor 116 to permit positioning aspirator/expression end 26 of
delivery section 24 within the cancellous bone 134 of hip joint 124
at a location of the osteolytic lesion 136.
[0046] The user 112 manipulates the aspirator/expression end 26 of
delivery section 24, while remaining outside of the path of the
x-ray beam between x-ray tube unit 116 and image intensifier 148,
as shown in FIG. 4. The suer 112 views the location and orientation
of aspirator/expression end 26 of delivery section 24 on television
monitor 116 while activating the pulse lavage action of the
debridement device 20. Throughout the procedure, the user 112
monitors the location and orientation of the aspirator/expression
end 26 to express the particulate abrasive-containing lavage fluid
from reservoir 40. In an embodiment, the user 112 delivers the
debridement fluid and aspirates the fluid by alternating pulse
lavage. This procedure effectively debrides the lesion 136 and
intermittently aspirates resistant osteolytic lesion constituents
including nacrotic and fibrous tissue and spent particulate
abrasive-containing lavage fluid.
[0047] While preferred embodiments of the invention have been
described, the present invention is capable of variation and
modification and therefore should not be limited to the precise
details of the above examples. For example, the invention relates
to a kit that is packaged to include the above-described components
for sale, shipment. The invention includes changes and alterations
that fall within the purview of the following claims.
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