U.S. patent application number 16/415691 was filed with the patent office on 2019-09-05 for negative pressure tissue debridement devices, systems, and methods.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE.
Application Number | 20190269432 16/415691 |
Document ID | / |
Family ID | 53757955 |
Filed Date | 2019-09-05 |
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United States Patent
Application |
20190269432 |
Kind Code |
A1 |
LOCKE; Christopher Brian |
September 5, 2019 |
Negative Pressure Tissue Debridement Devices, Systems, And
Methods
Abstract
In some embodiments, a debridement tool may include a housing, a
reduced-pressure lumen, a debridement head, an impeller, and a
drive system. The debridement head may be moveable relative to the
housing. The impeller may be positioned in fluid communication with
the reduced-pressure lumen and be moveable relative to the housing
by operation of reduced pressure being applied to the impeller. The
drive system may be coupled between the impeller and the
debridement head and be configured to impart movement from the
impeller to the debridement head.
Inventors: |
LOCKE; Christopher Brian;
(Bournemouth, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
53757955 |
Appl. No.: |
16/415691 |
Filed: |
May 17, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14689842 |
Apr 17, 2015 |
10335184 |
|
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16415691 |
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62007775 |
Jun 4, 2014 |
|
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62007790 |
Jun 4, 2014 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00561
20130101; A61B 2017/00553 20130101; A61B 17/3205 20130101; A61B
2017/320004 20130101; A61B 2017/00544 20130101; A61B 2017/00761
20130101; A61B 2217/005 20130101; A61B 2017/320012 20130101; A61B
17/54 20130101 |
International
Class: |
A61B 17/3205 20060101
A61B017/3205; A61B 17/54 20060101 A61B017/54 |
Claims
1. A debridement tool for debriding tissue from a tissue site,
comprising: a housing comprising an interior space; a
reduced-pressure lumen adapted to communicate reduced pressure; a
debridement head moveable relative to the housing; an impeller
moveable relative to the housing and positioned in fluid
communication with the reduced-pressure lumen; and a drive system
coupled between the impeller and the debridement head, the drive
system being configured to impart movement from the impeller to the
debridement head.
2. The debridement tool of claim 1, further comprising a working
surface adapted to face the tissue site, and a working surface port
disposed through the working surface.
3. The debridement tool of claim 2, wherein the working surface is
in fluid communication with the interior space through the working
surface port.
4. The debridement tool of claim 2, wherein the reduced-pressure
lumen is in fluid communication with the working surface through
the working surface port.
5. The debridement tool of claim 1, wherein the reduced-pressure
lumen is in fluid communication with the interior space.
6. The debridement tool of claim 1, further comprising a handle
coupled to the housing, wherein the reduced-pressure lumen is in
fluid communication with the interior space through the handle.
7. The debridement tool of claim 1, further comprising a feedback
pressure lumen adapted to communicate reduced pressure and being
positioned in fluid communication with the interior space.
8. The debridement tool of claim 7, further comprising a handle
coupled to the housing, wherein the feedback pressure lumen is in
fluid communication with the interior space through the handle.
9. The debridement tool of claim 1, wherein the debridement head
comprises a debridement head axis and an exterior surface rotatable
about the debridement head axis, the exterior surface of the
debridement head comprising an abrasive portion.
10. The debridement tool of claim 9, wherein the exterior surface
of the debridement head is cylindrical.
11. The debridement tool of claim 9, wherein the exterior surface
of the debridement head further comprises a non-abrasive
portion.
12. The debridement tool of claim 9, wherein the abrasive portion
is a plurality of abrasive portions, the exterior surface of the
debridement head further comprising a plurality of non-abrasive
portions, the abrasive portions being positioned between the
non-abrasive portions about the exterior surface of the debridement
head.
13. The debridement tool of claim 9, wherein the abrasive portion
is selected from a group consisting of: a coating of grit;
protruding bristles; and protruding wires.
14. The debridement tool of claim 9, wherein the abrasive portion
comprises at least one cutting tooth.
15. The debridement tool of claim 9, wherein the housing further
comprises a working surface adapted to face the tissue site, and a
working surface port disposed through the working surface, at least
a portion of the exterior surface of the debridement head being
adapted to protrude through the working surface port.
16. The debridement tool of claim 15, wherein the exterior surface
of the debridement head is adapted to protrude through the working
surface port and beyond the working surface between about 0.5
millimeters to about 2.0 millimeters.
17. The debridement tool of claim 1, wherein the debridement head
is positioned within the interior space.
18. The debridement tool of claim 1, wherein the impeller comprises
an impeller axis and a plurality of impeller vanes rotatable about
the impeller axis.
19. The debridement tool of claim 18, wherein the impeller is
adapted to rotate by operation of reduced pressure being applied to
the impeller vanes.
20. The debridement tool of claim 1, wherein the impeller is
positioned in fluid communication with the interior space.
21. The debridement tool of claim 1, wherein the impeller is
positioned within the interior space.
22. The debridement tool of claim 1, wherein the drive system
comprises an impeller pulley, a debridement head pulley, and a
drive belt, the impeller pulley being coupled to the impeller and
moveable with the impeller, the debridement head pulley being
coupled to the debridement head and moveable with the debridement
head, the drive belt being positioned about the impeller pulley and
the debridement head pulley.
23. A debridement tool for debriding tissue from a tissue site,
comprising: a housing comprising an interior space and a working
surface, the working surface being adapted to face the tissue site,
and a working surface port being disposed through the working
surface; a reduced-pressure lumen in fluid communication with the
working surface through the working surface port; a debridement
head moveable relative to the housing; an impeller moveable
relative to the housing and positioned in fluid communication with
the reduced-pressure lumen; and a drive system coupled between the
impeller and the debridement head, the drive system being
configured to impart movement from the impeller to the debridement
head.
24. The debridement tool of claim 23, wherein the working surface
is in fluid communication with the interior space through the
working surface port.
25. The debridement tool of claim 23, wherein the reduced-pressure
lumen is in fluid communication with the interior space.
26. The debridement tool of claim 23, further comprising a handle
coupled to the housing, wherein the reduced-pressure lumen is in
fluid communication with the interior space through the handle.
27. The debridement tool of claim 23, further comprising a feedback
pressure lumen adapted to communicate reduced pressure and being
positioned in fluid communication with the interior space.
28. The debridement tool of claim 23, wherein the debridement head
comprises a debridement head axis and an exterior surface rotatable
about the debridement head axis, the exterior surface of the
debridement head comprising an abrasive portion.
29. The debridement tool of claim 28, wherein the abrasive portion
is a plurality of abrasive portions, the exterior surface of the
debridement head further comprising a plurality of non-abrasive
portions, the abrasive portions being positioned between the
non-abrasive portions about the exterior surface of the debridement
head.
30. The debridement tool of claim 28, wherein the abrasive portion
is selected from a group consisting of: a coating of grit;
protruding bristles; protruding wires; and at least one cutting
tooth.
31. The debridement tool of claim 28, wherein at least a portion of
the exterior surface of the debridement head is adapted to protrude
through the working surface port.
32. The debridement tool of claim 23, wherein the debridement head
is positioned within the interior space.
33. The debridement tool of claim 23, wherein the impeller
comprises an impeller axis and a plurality of impeller vanes
rotatable about the impeller axis.
34. The debridement tool of claim 33, wherein the impeller is
adapted to rotate by operation of reduced pressure being applied to
the impeller vanes.
35. The debridement tool of claim 23, wherein the impeller is
positioned in fluid communication with the interior space.
36. The debridement tool of claim 23, wherein the impeller is
positioned within the interior space.
37. The debridement tool of claim 23, wherein the drive system
comprises an impeller pulley, a debridement head pulley, and a
drive belt, the impeller pulley being coupled to the impeller and
moveable with the impeller, the debridement head pulley being
coupled to the debridement head and moveable with the debridement
head, the drive belt being positioned about the impeller pulley and
the debridement head pulley.
38. A debridement tool for debriding tissue from a tissue site,
comprising: a housing comprising an interior space and a working
surface, the working surface adapted to face a tissue site and
having a working surface port disposed through the working surface,
the working surface being in fluid communication with the interior
space through the working surface port; a handle coupled to the
housing; a reduced-pressure lumen in fluid communication with the
working surface port, the reduced-pressure lumen being adapted to
communicate reduced pressure, the reduced-pressure lumen being in
fluid communication with the interior space through the handle; a
feedback pressure lumen in fluid communication with the interior
space, the feedback pressure lumen being adapted to communicate
reduced pressure, the feedback pressure lumen being in fluid
communication with the interior space through the handle; a
debridement head moveable relative to the housing, the debridement
head having an exterior surface rotatable about a debridement head
axis, the exterior surface of the debridement head comprising an
abrasive portion, the debridement head being positioned within the
interior space and at least a portion of the exterior surface of
the debridement head being adapted to protrude through the working
surface port; an impeller moveable relative to the housing and
positioned in fluid communication with the reduced-pressure lumen,
the impeller comprising a plurality of impeller vanes rotatable
about an impeller axis, the impeller adapted to rotate by operation
of reduced pressure being applied to the impeller vanes, the
impeller being positioned in fluid communication with the interior
space; and a drive system coupled between the impeller and the
debridement head, the drive system comprising an impeller pulley, a
debridement head pulley, and a drive belt, the impeller pulley
coupled to the impeller and rotatable about the impeller axis, the
debridement head pulley coupled to the debridement head and
rotatable about the debridement head axis, the drive belt being
positioned about the impeller pulley and the debridement head
pulley, the drive system being configured to impart movement from
the impeller to the debridement head.
39. A method for debriding tissue at a tissue site, comprising:
providing a debridement tool, comprising: a housing comprising a
working surface, a debridement head moveable relative to the
working surface, an impeller, and a drive system coupled between
the impeller and the debridement head; communicating reduced
pressure to the working surface; communicating reduced pressure to
the impeller, the impeller configured to rotate by operation of
reduced pressure being applied thereto; moving the debridement head
relative to the working surface with the drive system, the drive
system being operable to impart movement from the impeller to the
debridement head; and positioning the debridement head in contact
with the tissue site.
40. The method of claim 39, further comprising dislodging necrotic
tissue from the tissue site by moving the debridement head relative
to the tissue site when the debridement head is in contact with the
tissue site and reduced pressure is being communicated to the
impeller.
41. The method of claim 40, further comprising removing dislodged
necrotic tissue from the tissue site by operation of reduced
pressure being communicated to the working surface.
42. The method of claim 40, further comprising communicating
dislodged necrotic tissue into a canister for disposal by operation
of the reduced pressure being communicated to the working
surface.
43. The method of claim 39, wherein the housing further comprises
an interior space and a working surface port disposed through the
working surface in fluid communication with the interior space, the
method further comprising comparing a reduced pressure output being
communicated to the working surface with a feedback reduced
pressure measured within the interior space of the housing, wherein
the reduced pressure is communicated to the working surface and the
tissue site through the working surface port.
44. The method of claim 43, further comprising signaling a
debridement tubing blockage alarm if the reduced pressure output is
at a maximum reduced pressure and the feedback reduced pressure is
substantially zero.
45. The method of claim 44, wherein the maximum reduced pressure is
between about -300 mm Hg to about -400 mm Hg.
46. The method of claim 43, further comprising signaling a partial
head blockage alarm if the feedback reduced pressure is between
about -5 mm Hg to about -100 mm Hg.
47. The method of claim 43, further comprising: increasing the
reduced pressure output to a maximum reduced pressure for a set
time period if the feedback reduced pressure is greater than -100
mmHg; signaling a full head blockage alarm if the feedback reduced
pressure is greater than -100 mm Hg after the set time period; and
shutting off the reduced pressure output if the feedback reduced
pressure is greater than -100 mmHg after the set time period.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/689,842, filed Apr. 17, 2015, which claims
priority to U.S. Provisional Patent Application Ser. No.
62/007,790, filed Jun. 4, 2014, and U.S. Provisional Patent
Application Ser. No. 62/007,775, filed Jun. 4, 2014. The entire
contents of each of the applications set forth above are expressly
incorporated herein by reference.
FIELD
[0002] This disclosure relates generally to medical treatment
systems and, more particularly, but not by way of limitation, to
debridement devices, systems, and methods suitable for debriding a
tissue site.
BACKGROUND
[0003] Debridement may refer to a process for removing dead,
damaged, or infected tissue from a tissue site for improving the
healing potential of healthy tissue remaining at the tissue site.
Several factors may make proper debridement difficult, such as
challenging wound locations, immobile patients, and environmental
constraints. Further, training in the proper use of debridement
tools may be time consuming, thereby presenting additional
challenges. For example, the action of cutting or abrading away
dislodged eschar or necrotic tissue may be difficult to perform
with conventional debridement tools, which may be capable of
causing damage to healthy tissue and extensive bleeding. Thus,
specialized training may be required in proper debridement
techniques for performing thorough debridement of a tissue site
while minimizing damage to healthy tissue. Therefore, improvements
to debridement tools, systems, and methods that may reduce the
amount of training and risk of damage to healthy tissue associated
with conventional methodologies may be desirable.
SUMMARY
[0004] Shortcomings with certain aspects of tissue debridement
tools, systems, and methods are addressed as shown and described in
a variety of illustrative, non-limiting embodiments herein.
[0005] In some embodiments, a debridement tool for debriding tissue
from a tissue site may include a housing, a reduced-pressure lumen,
a debridement head, an impeller, and a drive system. The housing
may have an interior space. The reduced-pressure lumen may be
adapted to communicate reduced pressure. The debridement head may
be moveable relative to the housing. The impeller may be moveable
relative to the housing and positioned in fluid communication with
the reduced-pressure lumen. The drive system may be coupled between
the impeller and the debridement head. Further, the drive system
may be configured to impart movement from the impeller to the
debridement head.
[0006] In other embodiments, a debridement tool for debriding
tissue from a tissue site may include a housing, a reduced-pressure
lumen, a debridement head, an impeller, and a drive system. The
housing may include an interior space and a working surface. The
working surface may be adapted to face the tissue site, and a
working surface port may be disposed through the working surface.
The reduced-pressure lumen may be adapted to communicate reduced
pressure and may be in fluid communication with the working surface
through the working surface port. The debridement head may be
moveable relative to the housing. The impeller may be moveable
relative to the housing and positioned in fluid communication with
the reduced-pressure lumen. The drive system may be coupled between
the impeller and the debridement head. Further, the drive system
may be configured to impart movement from the impeller to the
debridement head.
[0007] In other embodiments, a debridement tool for debriding
tissue from a tissue site may include a housing, a handle, a
reduced-pressure lumen, a feedback pressure lumen, a debridement
head, an impeller, and a drive system. The housing may include an
interior space and a working surface. The working surface may be
adapted to face a tissue site and may have a working surface port
disposed through the working surface. Further, the working surface
may be in fluid communication with the interior space through the
working surface port. The handle may be coupled to the housing. The
reduced-pressure lumen may be in fluid communication with the
working surface port and may be adapted to communicate reduced
pressure. Further, the reduced-pressure lumen may be in fluid
communication with the interior space through the handle. The
feedback pressure lumen may be in fluid communication with the
interior space and may be adapted to communicate reduced pressure.
Further, the feedback pressure lumen may be in fluid communication
with the interior space through the handle. The debridement head
may be moveable relative to the housing and may have an exterior
surface rotatable about a debridement head axis. The exterior
surface of the debridement head may comprise an abrasive portion.
Further, the debridement head may be positioned within the interior
space, and at least a portion of the exterior surface of the
debridement head may be adapted to protrude through the working
surface port. The impeller may be moveable relative to the housing
and may be positioned in fluid communication with the
reduced-pressure lumen. The impeller may include a plurality of
impeller vanes rotatable about an impeller axis and may be adapted
to rotate by operation of reduced pressure being applied to the
impeller vanes. Further, the impeller may be positioned in fluid
communication with the interior space. The drive system may be
coupled between the impeller and the debridement head. The drive
system may include an impeller pulley, a debridement head pulley,
and a drive belt. The impeller pulley may be coupled to the
impeller and rotatable about the impeller axis. The debridement
head pulley may be coupled to the debridement head and rotatable
about the debridement head axis. The drive belt may be positioned
about the impeller pulley and the debridement head pulley such that
the drive system may be configured to impart movement from the
impeller to the debridement head.
[0008] In some embodiments, system for debriding tissue from a
tissue site may include a debridement tool and a reduced-pressure
source. The debridement tool may include a housing, a
reduced-pressure lumen, a debridement head, an impeller, and a
drive system. The housing may have an interior space. The
reduced-pressure lumen may be adapted to communicate reduced
pressure. The debridement head may be moveable relative to the
housing. The impeller may be moveable relative to the housing and
positioned in fluid communication with the reduced-pressure lumen.
The drive system may be coupled between the impeller and the
debridement head. Further, the drive system may be configured to
impart movement from the impeller to the debridement head. The
reduced-pressure source may be in fluid communication with the
impeller through the reduced-pressure lumen.
[0009] In some embodiments, a method for debriding tissue at a
tissue site may include providing a debridement tool. The
debridement tool may include a housing, a debridement head, an
impeller, and a drive system. The housing may include a working
surface, and the debridement head may be moveable relative to the
working surface. The drive system may be coupled between the
impeller and the debridement head. The method may further include
communicating reduced pressure to the working surface, and
communicating reduced pressure to the impeller. The impeller may be
configured to rotate by operation of reduced pressure being applied
thereto. The method may further include moving the debridement head
relative to the working surface with the drive system, and
positioning the debridement head in contact with the tissue site.
The drive system may be operable to impart movement from the
impeller to the debridement head.
[0010] In other embodiments, a system for debriding tissue from a
tissue site may include a debridement tool, a therapy device, and a
multi-lumen conduit. The debridement tool may include a housing, a
handle, a reduced-pressure lumen, a feedback pressure lumen, a
debridement head, an impeller, and a drive system. The housing may
include an interior space and a working surface. The working
surface may be adapted to face a tissue site and may have a working
surface port disposed through the working surface. Further, the
working surface may be in fluid communication with the interior
space through the working surface port. The handle may be coupled
to the housing. The reduced-pressure lumen may be in fluid
communication with the working surface port and may be adapted to
communicate reduced pressure. Further, the reduced-pressure lumen
may be in fluid communication with the interior space through the
handle. The feedback pressure lumen may be in fluid communication
with the interior space and may be adapted to communicate reduced
pressure. Further, the feedback pressure lumen may be in fluid
communication with the interior space through the handle. The
debridement head may be moveable relative to the housing and may
have an exterior surface rotatable about a debridement head axis.
The exterior surface of the debridement head may comprise an
abrasive portion. Further, the debridement head may be positioned
within the interior space, and at least a portion of the exterior
surface of the debridement head may be adapted to protrude through
the working surface port. The impeller may be moveable relative to
the housing and may be positioned in fluid communication with the
reduced-pressure lumen. The impeller may include a plurality of
impeller vanes rotatable about an impeller axis and may be adapted
to rotate by operation of reduced pressure being applied to the
impeller vanes. Further, the impeller may be positioned in fluid
communication with the interior space. The drive system may be
coupled between the impeller and the debridement head. The drive
system may include an impeller pulley, a debridement head pulley,
and a drive belt. The impeller pulley may be coupled to the
impeller and rotatable about the impeller axis. The debridement
head pulley may be coupled to the debridement head and rotatable
about the debridement head axis. The drive belt may be positioned
about the impeller pulley and the debridement head pulley such that
the drive system may be configured to impart movement from the
impeller to the debridement head.
[0011] The therapy device may include a reduced-pressure source, a
pressure sensor, and a canister. The reduced-pressure source may be
in fluid communication with the impeller and the working surface
port. Further, the reduced-pressure source may be in fluid
communication with the reduced-pressure lumen through the canister,
and the feedback pressure lumen may be in fluid communication with
the pressure sensor. The multi-lumen conduit may be coupled in
fluid communication between the debridement tool and the therapy
device. The multi-lumen conduit may include a primary lumen and a
secondary lumen. The primary lumen may be in fluid communication
with the reduced-pressure lumen, and the secondary lumen may be in
fluid communication with the feedback pressure lumen.
[0012] Other aspects, features, and advantages of the illustrative
embodiments will become apparent with reference to the drawings and
detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a cut-away view of an illustrative embodiment of a
system for debriding a tissue site, depicting an illustrative
embodiment of a debridement tool deployed at the tissue site;
[0014] FIG. 2 is a perspective, cut-away view of the debridement
tool of FIG. 1;
[0015] FIG. 3 is a top, cut-away view of the debridement tool of
FIG. 1; and
[0016] FIG. 4 is a bottom view of the debridement tool of FIG. 1,
depicting an illustrative embodiment of a working surface and a
working surface port.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0017] In the following detailed description of non-limiting,
illustrative embodiments, reference is made to the accompanying
drawings that form a part hereof. Other embodiments may be
utilized, and logical, structural, mechanical, electrical, and
chemical changes may be made without departing from the scope of
the appended claims. To avoid detail not necessary to enable those
skilled in the art to practice the embodiments described herein,
the description may omit certain information known to those skilled
in the art. Thus, the following detailed description is
non-limiting with the scope of the illustrative embodiments being
defined by the appended claims. As used herein, unless otherwise
indicated, the use of "or" does not require mutual exclusivity.
[0018] Referring to the drawings, FIG. 1 depicts an illustrative
embodiment of a system 102 for debriding tissue from a tissue site
104 of a patient. The tissue site 104 may extend through or
otherwise involve an epidermis 106, a dermis 108, and a
subcutaneous tissue 110. The tissue site 104 may be a sub-surface
tissue site as depicted in FIG. 1 that extends below the surface of
the epidermis 106. Further, the tissue site 104 may be a surface
tissue site (not shown) that predominantly resides on the surface
of the epidermis 106, such as, for example, an incision. The system
102 may also be utilized without limitation at other tissue
sites.
[0019] The tissue site 104 may be the bodily tissue of any human,
animal, or other organism, including bone tissue, adipose tissue,
muscle tissue, dermal tissue, vascular tissue, connective tissue,
cartilage, tendons, ligaments, or any other tissue. Debriding
tissue from the tissue site 104 may include the removal of fluids,
such as exudate or ascites, and the removal of necrotic tissue 112
from the tissue site 104 in effort to promote the healing of
healthy tissue 114.
[0020] The terms "debride", "debriding", and "debridement" as used
herein may refer to the removal of the necrotic tissue 112 to
improve the healing potential of the remaining healthy tissue 114.
The term "necrotic tissue" as used herein may refer to dead,
damaged, or infected tissue. Although in some embodiments the
debridement of necrotic tissue may involve an incision or cut to be
made at a tissue site, the disclosed embodiments may also be used
to debride necrotic tissue without requiring any such incisions or
cuts.
[0021] Referring to the illustrative embodiments of FIG. 1, the
system 102 may include a therapy device 120 and a debridement tool
124. The therapy device 120 may include a reduced-pressure source
128, a pressure sensor 132, and a canister 136. Components of the
system 102 may be omitted, added, or modified as described herein
in other embodiments. Further, components of the system 102 may be
provided integrally or separate where applicable. For example, the
reduced-pressure source 128, the pressure sensor 132, and the
canister 136 may be provided integrally as part of the therapy
device 120 as shown in FIG. 1, or as separate components.
[0022] The reduced-pressure source 128 may provide reduced pressure
to the debridement tool 124 and the tissue site 104. In some
embodiments, the canister 136 may be in fluid communication between
the reduced-pressure source 128 and the debridement tool 124 for
collecting fluids and other matter, such as exudate, dislodged
necrotic tissue, and waste, from the tissue site 104. For example,
reduced pressure may be communicated to the debridement tool 124
through the canister 136, whereby such fluids can be drawn through
the debridement tool 124 and communicated to the canister 136 by
operation of the reduced pressure being applied. The canister 136
may be any suitable containment device having a sealed internal
volume capable of retaining the fluids and other matter described
above.
[0023] The reduced-pressure source 128 may be any suitable device
for providing reduced pressure, such as, for example, a vacuum
pump, wall suction, hand pump, or other source. In some
embodiments, the reduced-pressure source 128 may be capable of
delivering a flow rate between about 5 liters per minute to about
10 liters per minute. In other embodiments, the flow rate may be
between about 6 liters per minute to about 8 liters per minute. As
an additional example, the reduced-pressure source 128 may be
provided as a component of an InfoV.A.C..RTM. therapy unit or a
V.A.C. Ulta.RTM. therapy unit available from Kinetic Concepts, Inc.
of San Antonio, Tex.
[0024] As used herein, the term "reduced pressure" may refer to a
pressure less than the ambient pressure at a tissue site being
treated or debrided. In some embodiments, the reduced pressure may
be less than the atmospheric pressure. In some embodiments, the
reduced pressure may be less than a hydrostatic pressure at a
tissue site. Unless otherwise indicated, values of pressure stated
herein are gauge pressures. While the amount and nature of reduced
pressure applied to a tissue site may vary according to the
application, the reduced pressure may be between about 0 mm Hg to
about -500 mm Hg. In some embodiments, the reduced pressure may be
between about -75 mm Hg to about -200 mm Hg.
[0025] The reduced pressure delivered may be constant, varied,
patterned, or random, and may be delivered continuously or
intermittently. Although the terms "vacuum" and "negative pressure"
may be used to describe the pressure applied to the debridement
tool 124 and the tissue site 104, the actual pressure may be more
than the pressure normally associated with a complete vacuum.
Further, an increase in reduced pressure may correspond to a
reduction in pressure (more negative relative to ambient pressure),
and a decrease in reduced pressure may correspond to an increase in
pressure (less negative relative to ambient pressure).
[0026] Referring to FIGS. 1-4, the debridement tool 124 may include
a housing 144, a reduced-pressure lumen 148, a debridement head
152, an impeller 156, and a drive system 160. The housing 144 may
include an interior space 162 and a working surface 164. The
working surface 164 may be adapted to face the tissue site 104, and
may have a working surface port 166 disposed through the working
surface 164. The working surface 164 may be in fluid communication
with the interior space 162 through the working surface port 166.
Further, the reduced-pressure source 128 may be in fluid
communication with the working surface 164 through the working
surface port 166. In some embodiments, a handle 168 may be coupled
to the housing 144 to provide a user with an ergonomic grip for the
debridement tool 124. Components of the debridement tool 124 may be
coupled to or otherwise associated with the housing 144 in any
suitable manner consistent with the operational parameters
described herein.
[0027] The housing 144 of the debridement tool 124 may comprise a
medical-grade polymer, metal, or other suitable material. As
non-limiting examples, the housing 144 may be formed from
polyurethane, polyethylene, polyvinyl chloride (PVC),
fluorosilicone, ethylene-propylene, ABS, or similar material. In
some illustrative, non-limiting embodiments, the housing 144 may be
molded from DEHP-free PVC, ABS or other suitable medical grade
polymer. The housing 144 may be formed in any suitable manner such
as by molding, casting, machining, or extruding. Further, the
housing 144 may be formed as an integral unit or as individual
components.
[0028] The reduced-pressure lumen 148 may be in fluid communication
with the working surface 164 through the working surface port 166
for communicating reduced pressure. In some embodiments, the
reduced-pressure lumen 148 may be in fluid communication with the
interior space 162 through the handle 168. Further, the
reduced-pressure source 128 may be in fluid communication with the
reduced-pressure lumen 148 through the canister 136.
[0029] In some embodiments, a feedback pressure lumen 170 may be in
fluid communication with the interior space 162 of the housing 144.
For example, the feedback pressure lumen 170 may be in fluid
communication with the interior space 162 through the handle 168.
Further, the feedback pressure lumen 170 may be fluidly isolated
from the reduced-pressure lumen 148 along the length of the handle
168. In some embodiments, the feedback pressure lumen 170 may be in
fluid communication with the pressure sensor 132. For example, the
feedback pressure lumen 170 may be adapted to communicate reduced
pressure, such as a reduced pressure feedback signal, from the
debridement tool 124 and/or the tissue site 104 to the pressure
sensor 132. Thus, although in some embodiments the feedback
pressure lumen 170 and the reduced-pressure lumen 148 may be in
fluid communication with the interior space 162, the feedback
pressure lumen 170 and the reduced-pressure lumen 148 may be
physically separate from one another.
[0030] The debridement head 152 may be moveable relative to the
housing 144 and may be cylindrical in shape. In some embodiments,
the debridement head 152 may have an exterior surface 172 rotatable
about a debridement head axis 174. As shown in FIGS. 2-4, the
exterior surface 172 of the debridement head 152 may comprise an
abrasive portion 176. In some embodiments, the exterior surface 172
of the debridement head 152 may comprise the abrasive portion 176
and an optional non-abrasive portion 178. The debridement head 152
may be positioned within the interior space 162, and at least a
portion of the exterior surface 172 of the debridement head 152 may
be adapted to protrude through the working surface port 166. In
some embodiments, the exterior surface 172 of the debridement head
152 may be adapted to protrude through the working surface port 166
and beyond the working surface 164 by a debridement depth 180
between about 0.5 millimeters to about 2.0 millimeters.
[0031] Referring to FIGS. 2-3, in some embodiments, the exterior
surface 172 of the debridement head 152 may comprise a plurality of
the abrasive portions 176 and a plurality of the non-abrasive
portions 178. The abrasive portions 176 may be positioned between
the non-abrasive portions 178 about a circumference of the exterior
surface 172 of the debridement head 152. Such a configuration
alternating the abrasive portions 176 and the non-abrasive portions
178 may enhance the ability of the debridement head 152 to rotate
in contact with the tissue site 104 without becoming bound against
the tissue site 104. The abrasive portions 176 may comprise any
suitable abrasive material such as, for example, a coarse grade
sandpaper, a coating of grit, crushed media, or similar material.
In some embodiments, the abrasive portions 176 may comprise without
limitation protruding polymer bristles, metal wire, fibers, or
cutting teeth. Further, a variety of interchangeable debridement
heads 152 having different combinations of abrasives as described
above may be provided in a kit with the debridement tool 124.
[0032] Continuing with FIGS. 2-3, the impeller 156 may be moveable
relative to the housing 144 and be positioned in fluid
communication with the reduced-pressure lumen 148. In some
embodiments, the impeller 156 may include a plurality of impeller
vanes 184 rotatable about an impeller axis 186. The impeller 156
may be adapted to rotate by operation of reduced pressure being
applied to the impeller vanes 184. For example, the impeller 156
may be positioned within the interior space 162 and/or in fluid
communication with the interior space 162 in the path of reduced
pressure being communicated therethrough. In some embodiments, the
reduced-pressure source 128 may be in fluid communication with the
impeller 156 through the reduced-pressure lumen 148.
[0033] Referring to FIGS. 1-3, the drive system 160 may be coupled
to or between the impeller 156 and the debridement head 152. In
some embodiments, the drive system 160 may include an impeller
pulley 188, a debridement head pulley 190, and a drive belt 192.
The impeller pulley 188 may be coupled to the impeller 156 and be
rotatable with the impeller 156 about the impeller axis 186. The
debridement head pulley 190 may be coupled to the debridement head
152 and be rotatable with the debridement head 152 about the
debridement head axis 174. The drive belt 192 may be positioned
about the impeller pulley 188 and the debridement head pulley 190
such that the drive system 160 may be configured to impart movement
from the impeller 156 to the debridement head 152. Although FIG. 3
depicts the drive system 160 positioned at each opposing end of the
debridement head axis 174 and the impeller axis 186, other
embodiments may use the drive system 160 at only one end of the
debridement head axis 174 and the impeller axis 186. Further,
although not explicitly shown in the drawings, the housing 144 may
have, for example, brackets, pins, axles, bearings and other such
devices for coupling or associating the impeller 156, the
debridement head 152, the drive system 160, and other components of
the debridement tool 124 with the housing 144 as described
herein.
[0034] Referring to FIG. 1, the debridement tool 124 may be coupled
in fluid communication with the therapy device 120, or individual
components of the therapy device 120 set forth above. For example,
the reduced-pressure lumen 148 of the debridement tool 124 may be
in fluid communication with the reduced-pressure source 128, and
the feedback pressure lumen 170 of the debridement tool 124 may be
in fluid communication with the pressure sensor 132. In some
embodiments, the reduced-pressure source 128 may be in fluid
communication with the impeller 156 and the working surface port
166. Further, in some embodiments, the reduced-pressure source 128
may be in fluid communication with the impeller 156 through the
reduced-pressure lumen 148. Even further, in some embodiments, the
reduced-pressure source 128 may be in fluid communication with the
reduced-pressure lumen 148 through the canister 136.
[0035] Continuing with FIG. 1, in some embodiments, a multi-lumen
conduit 194 may be coupled in fluid communication between the
debridement tool 124 and the therapy device 120. The multi-lumen
conduit 194 may include multiple lumens, such as a primary lumen
196 and a secondary lumen 198. The reduced-pressure lumen 148 may
be coupled in fluid communication with the primary lumen 196 for
providing fluid communication with the reduced-pressure source 128.
Further, the feedback pressure lumen 170 may be coupled in fluid
communication with the secondary lumen 198 for providing fluid
communication with the pressure sensor 132. The primary lumen 196
may be substantially isolated from fluid communication with the
secondary lumen 198 along the length of the multi-lumen conduit
194. Although shown in FIG. 1 as having a substantially circular
cross-section, the multi-lumen conduit 194 may have any shape to
suit a particular application. Further, the multi-lumen conduit 194
may comprise, for example, a flexible polymer. Each distal end of
the multi-lumen conduit 194 may include a connector 199 for
coupling the multi-lumen conduit 194 in fluid communication between
the therapy device 120 and the debridement tool 124.
[0036] Referring to FIGS. 1-4, in an illustrative embodiment of
operation, the working surface 164 of the debridement tool 124 may
be positioned proximate to or in contact with the necrotic tissue
112 at the tissue site 104. The external surface 172 of the
debridement head 152 may be positioned in contact with the necrotic
tissue 112, and the working surface port 166 may be positioned in
fluid communication with the tissue site 104. Reduced pressure may
be communicated from the reduced-pressure source 128 to the
impeller 156 of the debridement tool 124 and to the tissue site 104
through the working surface port 166. Reduced pressure may induce
fluid flow across the impeller vanes 184 of the impeller 156 to
impart movement or rotation on the impeller 156. Rotation of the
impeller 156 and the impeller pulley 188 coupled to the impeller
156 may be operable to impart rotation on the debridement head 152
in a corresponding manner. For example, the drive belt 192 that may
be coupled between the impeller pulley 188 and the debridement head
pulley 190 may impart rotational movement from the impeller 156 to
the debridement head 152. Such movement of the debridement head 152
while being positioned in contact with the necrotic tissue 112 may
operate to debride or otherwise dislodge the necrotic tissue 112
from the tissue site 104. A saline or water solution may be added
at the tissue site 104 to assist with dislodging the necrotic
tissue 112, preventing blockages, and reducing pain for the
patient.
[0037] Reduced pressure being applied to the tissue site 104 may
extract the dislodged necrotic tissue 112, fluids, wound exudate,
or other waste material from the tissue site 104 without disturbing
the healthy tissue 114 that may surround and/or underlie the
necrotic tissue 112. Further, since the external surface 172 of the
debridement head 152 may protrude through the working surface port
166, the working surface 166 may operate as a guard or guide for
the debridement operation. For example, the working surface 166 may
substantially preclude the debridement head 152 from entering or
engaging the tissue site 104 at a depth beyond the prescribed
debridement depth 180, which may damage or disrupt the healthy
tissue 114. In this manner, the debridement tool 124 according to
this disclosure may provide enhanced control for the user and
safety for the patient, which may also reduce the amount of
training required for use of the debridement tool 124. Further,
since the debridement tool 124 is mechanical in operation by virtue
of reduced pressure incident on the impeller 156, the debridement
tool 124 may provide the user with a low cost, disposable option
for performing debridement.
[0038] Further, the therapy device 120 may be configured to control
the amount of reduced pressure from the reduced-pressure source 128
being applied to the debridement tool 124 and the tissue site 104
according to a user input and/or reduced-pressure feedback signal.
For example, the reduced-pressure feedback signal may be
communicated from the feedback pressure lumen 170 of the
debridement tool 124 to the pressure sensor 132. The therapy device
120 and the system 102 may include additional control circuitry,
processors, and sensors as necessary for processing and monitoring
the reduced pressure being applied to the debridement tool 124 and
the tissue site 104. For example, a processor (not shown) including
a control algorithm may be associated with the pressure sensor 132
in any suitable manner for controlling the output from the
reduced-pressure source 128 according to the reduced-pressure
feedback signal and/or user input.
[0039] In some embodiments, a feedback reduced pressure less than
about -5 mm Hg and decreasing to about 0 mm Hg may be measured at
the working surface 164 and/or the tissue site 104 through the
feedback pressure lumen 170 in normal operation of the system 102.
If the reduced pressure output measured at the reduced-pressure
source 128 reaches a maximum reduced pressure, such as between
about -300 mm Hg to about -400 mm Hg, while the feedback reduced
pressure is less than about -5 mm Hg, or about 0 mm Hg, then a
debridement tubing blockage alarm may be reported. The debridement
tubing blockage alarm may indicate a blockage in the
reduced-pressure lumen 148. In other embodiments, the maximum
reduced pressure may be between about -300 mm Hg to about -380 mm
Hg.
[0040] In some embodiments, if the feedback reduced pressure is
between about -5 mm Hg to about -100 mm Hg, then a partial
head-blockage alarm may be reported. The partial head-blockage
alarm may indicate a partial blockage in the debridement tool 124,
such as, for example, at or among the interior space 162 of the
housing 144, the debridement head 152, the working surface 164, or
the working surface port 166. The partial head-blockage alarm may
serve as an alert to the user that the debridement tool 124
requires cleaning or replacement, but the system 102 may otherwise
remain operable during a partial head-blockage alarm.
[0041] In some embodiments, if the feedback reduced pressure is
greater than about -100 mm Hg, then the reduced-pressure source 128
may increase the reduced pressure output to the maximum reduced
pressure set forth above for a set time period to remediate the
blockage. If the feedback reduced pressure does not decrease or
otherwise move toward normal operational levels, such as about 0 mm
Hg, after the set time period, then a full head blockage alarm may
be reported and the system 102 may shut down.
[0042] Based on the above operational and control parameters, the
system 102 can detect blockages in the debridement tool 124 that
may prevent components of the debridement tool 124 from rotating,
such as the debridement head 152. Further, the system 102 may be
configured to detect if the debridement tool 124 has become sealed
against the tissue site 104, restricting flow and causing an
increase in reduced pressure at the tissue site 104. The system 102
may take the steps described above to alert a user and shut down
the reduced-pressure source 128 as necessary.
[0043] In some illustrative embodiments, a method for debriding the
tissue site 104 may include providing the debridement tool 124. In
some embodiments, the debridement tool 124 may include the housing
144, the debridement head 152, the impeller 156, and the drive
system 160. The housing 144 may include the interior space 162 and
the working surface 164. The working surface port 166 may be
disposed through the working surface 164 and in fluid communication
with the interior space 162. The debridement head 152 may be
moveable relative to the housing 144, and the drive system 160 may
be coupled between the impeller 156 and the debridement head
152.
[0044] The method may further include communicating reduced
pressure to the working surface 164 and communicating reduced
pressure to the impeller 156. In some embodiments, the reduced
pressure may be communicated to the working surface 164 through the
working surface port 166. In other embodiments, the reduced
pressure may be communicated to the working surface 164 and/or the
tissue site 104, for example, by a lumen or conduit (not shown)
that may be separate from, integral with, or attached to the
debridement tool 124. The impeller 156 may be configured to rotate
by operation of reduced pressure being applied to the impeller 156.
Further, the method may include moving the debridement head 152
relative to the housing 144 with the drive system 160, and
positioning the debridement head 152 in contact with the tissue
site 104. In some embodiments, the working surface 164 may be
positioned in contact with the tissue site 104 along with the
debridement head 152. The drive system 160 may be operable to
impart movement from the impeller 156 to the debridement head
152.
[0045] In some embodiments, the method may further include
dislodging the necrotic tissue 112 from the tissue site 104 by
moving the debridement head 152 relative to the tissue site 104
when the debridement head 152 is in contact with the tissue site
104 and reduced pressure is being communicated to the impeller 156.
In some embodiments, the method may further include removing
dislodged necrotic tissue 112 from the tissue site 104 by operation
of reduced pressure being communicated to the working surface 164.
In some embodiments, the method may further include communicating
dislodged necrotic tissue 112 into the canister 136 by operation of
the reduced pressure being applied to the working surface 164.
[0046] In some embodiments, the method may further include
comparing a reduced pressure output being communicated to the
working surface 164 with a feedback reduced pressure measured
within the interior space 162 of the housing 144. In some
embodiments, the method may further include signaling a debridement
tubing blockage alarm if the reduced pressure output is at a
maximum reduced pressure and the feedback reduced pressure is
substantially zero, or between about 0 mm Hg to about -5 mm Hg. In
some embodiments, the method may further include signaling a
partial head-blockage alarm if the feedback reduced pressure is
between about -5 mm Hg to about -100 mm Hg.
[0047] In some embodiments, the method may further include:
increasing the reduced pressure output to a maximum pressure for a
set time period if the feedback reduced pressure is greater than
-100 mm Hg; signaling a full head blockage alarm if the feedback
reduced pressure is greater than -100 mm Hg after the set time
period; and shutting off the reduced pressure output if the
feedback reduced pressure is greater than -100 mm Hg after the set
time period.
[0048] Although this specification discloses advantages in the
context of certain illustrative, non-limiting embodiments, various
changes, substitutions, permutations, and alterations may be made
without departing from the scope of the appended claims. Further,
any feature described in connection with any one embodiment may
also be applicable to any other embodiment.
* * * * *