U.S. patent application number 16/439993 was filed with the patent office on 2019-09-26 for manifolds, systems, and methods for administering reduced pressure to a subcutaneous tissue site.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Douglas A. CORNET, Justin Alexander LONG, Michael E. MANWARING, Carl Joseph SANTORA, Larry D. SWAIN.
Application Number | 20190290835 16/439993 |
Document ID | / |
Family ID | 42316753 |
Filed Date | 2019-09-26 |
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United States Patent
Application |
20190290835 |
Kind Code |
A1 |
SANTORA; Carl Joseph ; et
al. |
September 26, 2019 |
MANIFOLDS, SYSTEMS, AND METHODS FOR ADMINISTERING REDUCED PRESSURE
TO A SUBCUTANEOUS TISSUE SITE
Abstract
Systems, methods, and apparatuses are provided for delivering
reduced pressure to a subcutaneous tissue site, such as a bone
tissue site. In one instance, a manifold for providing reduced
pressure to a subcutaneous tissue includes a longitudinal manifold
body formed with at least one purging lumen and a reduced-pressure
lumen. The manifold further includes a plurality of manifolding
surface features or slits formed on the second, tissue-facing side
of the longitudinal manifold body and a plurality of apertures
formed in the longitudinal manifold body on the second,
tissue-facing side. The plurality of apertures fluidly couple the
reduced-pressure lumen and the manifolding surface features or
slits. The manifold further includes an end cap fluidly coupling
the reduced-pressure lumen and the at least one purging lumen.
Other systems, apparatuses, and methods are presented.
Inventors: |
SANTORA; Carl Joseph;
(Helotes, TX) ; MANWARING; Michael E.; (San
Antonio, TX) ; CORNET; Douglas A.; (Barboursville,
VA) ; LONG; Justin Alexander; (Lago Vista, TX)
; SWAIN; Larry D.; (San Antonio, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
42316753 |
Appl. No.: |
16/439993 |
Filed: |
June 13, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14569436 |
Dec 12, 2014 |
10369269 |
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16439993 |
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12647146 |
Dec 24, 2009 |
8939933 |
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14569436 |
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12540934 |
Aug 13, 2009 |
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12647146 |
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11807834 |
May 29, 2007 |
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12540934 |
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11724072 |
Mar 13, 2007 |
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11807834 |
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11807834 |
May 29, 2007 |
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12540934 |
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11724072 |
Mar 13, 2007 |
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11807834 |
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11724072 |
Mar 13, 2007 |
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11807834 |
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61141728 |
Dec 31, 2008 |
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60782171 |
Mar 14, 2006 |
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60782171 |
Mar 14, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/3662 20130101;
A61F 2310/00592 20130101; A61M 25/0068 20130101; A61M 2025/0003
20130101; A61B 17/88 20130101; A61F 2310/00395 20130101; A61B 17/80
20130101; A61M 2025/0036 20130101; A61M 3/0283 20130101; A61M 27/00
20130101; A61F 2310/00928 20130101; A61F 2/30767 20130101; A61F
2002/3694 20130101; A61F 2002/30968 20130101; A61M 1/0058 20130101;
A61F 2002/3625 20130101; A61B 17/1355 20130101; A61M 25/0032
20130101; A61M 25/0074 20130101; A61F 2002/368 20130101; A61F
2002/3611 20130101; A61M 25/0009 20130101; A61M 2207/00 20130101;
A61M 25/007 20130101; A61M 25/003 20130101; A61M 2210/02 20130101;
A61M 2025/0076 20130101; A61F 2002/30785 20130101; A61M 1/0084
20130101; A61M 25/0071 20130101; A61F 2/36 20130101; A61M 3/0295
20130101; A61M 2025/0034 20130101; A61F 2002/30677 20130101; A61M
1/0088 20130101; A61M 25/0082 20130101; A61F 2002/30787 20130101;
A61M 25/0069 20130101 |
International
Class: |
A61M 3/02 20060101
A61M003/02; A61B 17/88 20060101 A61B017/88; A61M 25/00 20060101
A61M025/00; A61F 2/36 20060101 A61F002/36; A61M 1/00 20060101
A61M001/00; A61M 27/00 20060101 A61M027/00 |
Claims
1. A manifold for providing reduced pressure, the manifold
comprising: a body having a first side and a second side, the first
side and the second side being non-uniform; a reduced-pressure
lumen disposed in the body and extending a length of the body; a
plurality of apertures formed on the second side of the body; and a
plurality of conduits disposed in the body and fluidly coupling the
plurality of apertures to the reduced-pressure lumen.
2. The manifold of claim 1, wherein the first side is curved
relative to the second side.
3. The manifold of claim 1, wherein the first side is curved and
the second side is substantially flat.
4. The manifold of claim 1, wherein the manifold is unibody.
5. The manifold of claim 1, wherein the body is formed from
silicone.
6. The manifold of claim 1, wherein the plurality of apertures have
a symmetrical pattern.
7. The manifold of claim 1, further comprising a plurality of
surface features formed on the second side of the body.
8. The manifold of claim 7, wherein the plurality of surface
features are configured to manifold reduced pressure.
9. The manifold of claim 7, wherein the plurality of surface
features comprise a plurality of standoffs.
10. The manifold of claim 7, wherein the plurality of surface
features comprise a plurality of offsets.
11. The manifold of claim 7, wherein the plurality of surface
features are integral to the body.
12. The manifold of claim 7, wherein the plurality of surface
features comprise a first longitudinal member and a second
longitudinal member, the first longitudinal member and the second
longitudinal member being parallel to each other and extending a
portion of a length of the body, each of the first longitudinal
member and the second longitudinal member separating a portion of
the apertures form the plurality of apertures.
13. The manifold of claim 1, further comprising a purging lumen
disposed in the body and extending a length of the body.
14. The manifold of claim 13, further comprising an end cap
disposed on a distal end of the body and fluidly coupling the
reduced-pressure lumen and the at least one purging lumen through a
header space in the end cap, the end cap being integral to the
body.
15. The manifold of claim 13, wherein the purging lumen comprises a
plurality of purging lumens.
16. The manifold of claim 15, wherein the plurality of purging
lumens are symmetrically spaced about the reduced-pressure
lumen.
17. The manifold of claim 13, wherein the purging lumen comprises a
first purging lumen, the manifold further comprising a second
purging lumen, the first purging lumen and the second purging lumen
symmetrically disposed about the reduced-pressure lumen.
18. The manifold of claim 1, further comprising a pressure-sensing
lumen.
19. The manifold of claim 1, further comprising a connecter coupled
to a proximal end of the body, the connecter configured to fluidly
couple a reduced-pressure delivery tube to the reduced-pressure
lumen.
20. The manifold of claim 1, further comprising one or more
radio-opaque markers configured to be imaged by fluoroscopy.
21. The manifold of claim 1, wherein the body is configured to be
imaged by ultrasound.
22. A system for providing reduced pressure to a tissue site
located proximate to a spine, the system comprising: a
reduced-pressure source; a reduced-pressure delivery conduit
configured to be fluidly coupled to the reduced-pressure source; a
manifold comprising: a body having a first side and a second side,
the first side and the second side being non-uniform, a
reduced-pressure lumen disposed in the body and extending a length
of the body, a plurality of apertures formed on the second side of
the body, and a plurality of conduits disposed in the body and
fluidly coupling the plurality of apertures to the reduced-pressure
lumen; and a connecter configured to be coupled to a proximal end
of the body, the connecter further configured to fluidly couple the
reduced-pressure delivery conduit to the reduced-pressure
lumen.
23. The system of claim 22, wherein the first side is curved
relative to the second side.
24. The system of claim 22, wherein the first side is curved and
the second side is substantially flat.
25. The system of claim 22, wherein the manifold is unibody.
26. The system of claim 22, wherein the body is formed from
silicone.
27. The system of claim 22, wherein the plurality of apertures have
a symmetrical pattern.
28. The system of claim 22, further comprising a plurality of
surface features formed on the second side of the body.
29. The system of claim 28, wherein the plurality of surface
features are configured to manifold reduced pressure.
30. The system of claim 28, wherein the plurality of surface
features comprise a plurality of standoffs.
31. The system of claim 28, wherein the plurality of surface
features comprise a plurality of offsets.
32. The system of claim 28, wherein the plurality of surface
features are integral to the body.
33. The system of claim 28, wherein the plurality of surface
features comprise a first longitudinal member and a second
longitudinal member, the first longitudinal member and the second
longitudinal member being parallel to each other and extending a
portion of a length of the body, each of the first longitudinal
member and the second longitudinal member separating a portion of
the apertures from the plurality of apertures.
34. The system of claim 33, further comprising a purging lumen
disposed in the body and extending a length of the body.
35. The system of claim 34, further comprising an end cap disposed
on a distal end of the body and fluidly coupling the
reduced-pressure lumen and the at least one purging lumen through a
header space in the end cap, the end cap being integral to the
body.
36. The system of claim 34, wherein the purging lumen comprises a
plurality of purging lumens.
37. The system of claim 36, wherein the plurality of purging lumens
are symmetrically spaced about the reduced-pressure lumen.
38. The system of claim 34, wherein the purging lumen comprises a
first purging lumen, the manifold further comprising a second
purging lumen, the first purging lumen and the second purging lumen
symmetrically disposed about the reduced-pressure lumen.
39. The system of claim 22, further comprising a pressure-sensing
lumen.
40. The system of claim 22, further comprising one or more
radio-opaque markers configured to be imaged by fluoroscopy.
41. The system of claim 22, wherein the body is configured to be
imaged by ultrasound.
42. A method of delivering reduced pressure to a tissue site, the
method comprising: inserting a manifold into a subcutaneous
location proximate to a spine, the manifold comprising: a body
having a first side and a second side, the first side and the
second side being non-uniform, a reduced-pressure lumen disposed in
the body and extending a length of the body; a plurality of
apertures formed on the second side of the body, a plurality of
conduits disposed in the body and fluidly coupling the plurality of
apertures to the reduced-pressure lumen, and a connecter coupled to
a proximal end of the body, the connecter configured to fluidly
couple a reduced-pressure delivery tube to the reduced-pressure
lumen; and supplying reduced pressure to the manifold from a
reduced-pressure source.
43. The method of claim 42, wherein the method further comprises
orienting the plurality of apertures to face the tissue site.
44. The method of claim 43, wherein the first side is curved and
the second side is substantially flat, and orienting the plurality
of apertures comprises rotating the manifold so that the second
side faces the tissue site.
45. The method of claim 42, wherein the manifold further comprises
a purging lumen disposed in the body and extending a length of the
body, the method further comprises supplying a purging fluid to the
purging lumen.
46. The method of claim 45, wherein the manifold further comprises
an end cap disposed on a distal end of the body and fluidly
coupling the reduced-pressure lumen and the at least one purging
lumen through a header space in the end cap, the end cap being
integral to the body.
47. The method of claim 42, wherein the manifold further comprises
a pressure-sensing lumen and the method further comprises sensing a
pressure at the tissue site through the pressure-sensing lumen.
48. The method of claim 42, wherein the manifold further comprises
one or more radio-opaque markers and the method further comprises
imaging the manifold using fluoroscopy.
49. The method of claim 42, wherein the method further comprises
imaging the manifold using ultrasound.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/569,436, filed Dec. 12, 2014, which is a
divisional of U.S. patent application Ser. No. 12/647,146, filed
Dec. 24, 2009, which is a continuation-in-part of U.S. patent
application Ser. No. 12/540,934, filed Aug. 13, 2009, a
continuation-in-part of U.S. patent application Ser. No.
11/807,834, filed May 29, 2007, a continuation in part of U.S.
patent application Ser. No. 11/724,072, filed Mar. 13, 2007, and
claims the benefit, under 35 USC .sctn. 119(e), of the filing of
U.S. Provisional Patent Application Ser. No. 61/141,728, filed Dec.
31, 2008. U.S. patent application Ser. No. 12/540,934, filed Aug.
13, 2009 is a continuation-in-part of U.S. patent application Ser.
No. 11/807,834, filed May 29, 2007, and a continuation-in-part of
U.S. patent application Ser. No. 11/724,072, filed on Mar. 13,
2007. U.S. patent application Ser. No. 11/807,834, filed May 29,
2007 is a continuation-in-part of U.S. patent application Ser. No.
11/724,072, filed Mar. 13, 2007, and claims the benefit of U.S.
Provisional Application Ser. No. 60/782,171, filed Mar. 14, 2006.
U.S. patent application Ser. No. 11/724,072, filed Mar. 13, 2007,
claims the benefit of U.S. Provisional Application Ser. No.
60/782,171. All of the above-referenced applications are hereby
incorporated by reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] The illustrative embodiments relate generally to systems,
apparatuses, and methods of promoting tissue growth and more
specifically a system for applying reduced-pressure tissue
treatment to a tissue site, such as a bone.
[0003] Reduced-pressure therapy is increasingly used to promote
wound healing in soft tissue wounds that are slow to heal or
non-healing without reduced-pressure therapy. Typically, reduced
pressure is applied to the wound site through an open-cell foam or
other device that serves as a manifold to distribute the reduced
pressure. The open-cell foam is sized to fit the existing wound,
placed into contact with the wound, and then periodically replaced
with smaller pieces of foam as the wound begins to heal and become
smaller. Frequent replacement of the open-cell foam may be
necessary to minimize the amount of tissue that grows into the
cells of the foam. Significant tissue in-growth can cause pain to
patients during removal of the foam.
[0004] Reduced-pressure therapy may be applied to non-healing, open
wounds. In some cases, the tissues being healed are subcutaneous,
and in other cases, the tissues are located within or on dermal
tissue. Traditionally, reduced-pressure therapy has primarily been
applied to soft tissues. Reduced-pressure therapy has not typically
been used to treat closed, deep-tissue wounds because of the
difficulty of access presented by such wounds. Additionally,
reduced-pressure therapy has not generally been used in connection
with healing bone defects or promoting bone growth, primarily due
to access problems.
BRIEF SUMMARY
[0005] To alleviate the existing problems with reduced-pressure
treatment systems, the illustrative embodiments described herein
are directed to a systems, methods, and apparatuses for applying a
reduced pressure to a subcutaneous tissue site. An apparatus
includes a manifold that is adapted to be inserted for placement at
the subcutaneous tissue site. The manifold may include at least one
purging lumen operable to deliver a fluid to a distal portion of
the manifold. The manifold may also include at least one slit at
the distal portion of the manifold. The manifold may include at
least one reduced-pressure lumen operable to deliver reduced
pressure to the subcutaneous tissue site via the at least one slit.
In one example, the manifold also includes an interlumen channel
fluidly interconnecting the at least one purging lumen, the at
least one reduced-pressure lumen, and the at least one slit at the
distal portion of the manifold.
[0006] According to one illustrative embodiment, a system for
applying a reduced pressure at a subcutaneous tissue site is also
provided. The system includes a reduced-pressure source operable to
supply reduced pressure to a manifold. The manifold may include at
least one reduced-pressure lumen operable to deliver reduced
pressure supplied from the reduced-pressure source to the
subcutaneous tissue site via at least one slit. The system may also
include a delivery tube in fluid communication with the manifold
and the reduced pressure source to deliver reduced pressure to the
at least one reduced-pressure lumen. The delivery tube may also
provide for the delivery of fluid to the at least one purge
lumen.
[0007] According to one illustrative embodiment, a method for
applying a reduced pressure at a subcutaneous tissue site is also
provided. The method may include applying a manifold to the
subcutaneous tissue site. The method may also include supplying a
reduced pressure to the manifold via a delivery tube.
[0008] According to one illustrative embodiment, a method of
manufacturing an apparatus for applying a reduced pressure at a
subcutaneous tissue site on a patient is also provided. The method
may include forming a manifold adapted to be inserted into the
patient and for placement at the subcutaneous tissue site. In one
example, the method may also include providing a delivery tube for
delivering reduced pressure to at least one reduced-pressure lumen
in the manifold and fluid to at least one purge lumen in the
manifold. In this example, the method may also include coupling the
delivery tube to the manifold such that the delivery tube is in
fluid communication with the manifold.
[0009] According to another illustrative embodiment, a manifold for
providing reduced pressure to a subcutaneous tissue site on a
patient includes a longitudinal manifold body formed with at least
one purging lumen and a reduced-pressure lumen. The manifold body
has a first side and a second, tissue-facing side. The manifold
further includes a plurality of manifolding surface features formed
on the second, tissue-facing side of the longitudinal manifold body
and a plurality of apertures formed in the longitudinal manifold
body on the second, tissue-facing side. The plurality of apertures
fluidly couple the reduced-pressure lumen and the manifolding
surface features. The manifold further includes an end cap fluidly
coupling the reduced-pressure lumen and the at least one purging
lumen.
[0010] According to another illustrative embodiment, a system for
treating a subcutaneous tissue site on a patient with reduced
pressure includes a reduced-pressure source, a manifold, and a
reduced pressure delivery tube coupling the reduced-pressure source
and the manifold. The manifold includes a longitudinal manifold
body formed with at least one purging lumen and a reduced-pressure
lumen. The manifold body has a first side and a second,
tissue-facing side. The manifold further includes a plurality of
manifolding surface features formed on the second, tissue-facing
side of the longitudinal manifold body and a plurality of apertures
formed in the longitudinal manifold body on the second,
tissue-facing side. The plurality of apertures fluidly couple the
reduced-pressure lumen and the manifolding surface features. The
manifold further includes an end cap fluidly coupling the
reduced-pressure lumen and the at least one purging lumen.
[0011] According to another illustrative embodiment, a method of
manufacturing a manifold for providing reduced pressure to a
subcutaneous tissue site on a patient includes forming a
longitudinal manifold body with at least one purging lumen and a
reduced-pressure lumen. The manifold body has a first side and a
second, tissue-facing side. The method further includes forming a
plurality of manifolding surface features on the second,
tissue-facing side of the longitudinal manifold body and forming a
plurality of apertures in the longitudinal manifold body on the
second, tissue-facing side. The plurality of apertures fluidly
couple the reduced-pressure lumen and the manifolding surface
features. The method further includes forming an end cap on the
manifold body that fluidly couples the reduced-pressure lumen and
the at least one purging lumen.
[0012] According to an illustrative, non-limiting embodiment, a
system for applying reduced pressure to a subcutaneous tissue site
that includes a reduced-pressure source for supplying reduced
pressure, a fluid source for supplying a fluid, and a manifold
adapted for placement at the subcutaneous tissue site. The manifold
includes a plurality of first conduits, each of the plurality of
first conduits having a wall formed with at least one first
aperture and at least one second aperture. At least one of the
plurality of first conduits is in fluid communication with the
reduced-pressure source and is operable to deliver the reduced
pressure to the subcutaneous tissue site via the at least one first
aperture. The manifold further includes a second conduit formed by
a portion of each wall of the plurality of first conduits. The
second conduit is in fluid communication with the plurality of
first conduits via the at least one second aperture. The system may
further include a delivery conduit fluidly coupled to the manifold
and reduced-pressure source.
[0013] According to another illustrative, non-limiting embodiment,
a manifold for applying reduced pressure to a subcutaneous tissue
site includes a plurality of first conduits, each of the plurality
of first conduits having a wall with at least one first aperture
and at least one second aperture. At least one of the plurality of
first conduits is operable to deliver reduced pressure to the
subcutaneous tissue site via the at least one first aperture. The
plurality of first conduits is coupled in a spaced arrangement that
forms an interior space. The manifold further includes a second
conduit comprising the interior space and formed by a portion of
each wall of the plurality of first conduits. The second conduit is
in fluid communication with the plurality of first conduits via the
at least one second aperture.
[0014] According to another illustrative, non-limiting embodiment,
a method for applying reduced pressure to a subcutaneous tissue
site includes providing a manifold, applying the manifold to the
subcutaneous tissue site, and supplying the reduced pressure to the
manifold via a delivery conduit. The manifold includes a plurality
of first conduits. Each of the plurality of first conduits has a
wall with at least one first aperture and at least one second
aperture. At least one of the plurality of first conduits is
operable to deliver reduced pressure to the subcutaneous tissue
site via the at least one first aperture. The plurality of first
conduits are coupled in a spaced arrangement that forms an interior
space. The manifold further includes a second conduit comprising
the interior space and formed by a portion of each wall of the
plurality of first conduits. The second conduit is in fluid
communication with the plurality of first conduits via the at least
one second aperture.
[0015] According to another illustrative, non-limiting embodiment,
a method of manufacturing an apparatus that is applying reduced
pressure to a subcutaneous tissue includes providing a plurality of
first conduits. Each of the plurality of first conduits has a wall
formed with at least one first aperture and at least one second
aperture. At least one of the plurality of first conduits is
operable to deliver reduced pressure to the subcutaneous tissue
site via the at least one first aperture. The method further
includes coupling the plurality of first conduits to one another to
form a second conduit. The second conduit is formed by a portion of
each wall of the plurality of first conduits and is in fluid
communication with the plurality of first conduits via the at least
one second aperture.
[0016] According to another illustrative, non-limiting embodiment,
a medical manifold for delivering one or more fluids to a tissue
site includes a plurality of exterior conduits coupled in a spaced
relationships to define an interior space between the plurality of
exterior conduits. The interior space comprises a central conduit.
The medical manifold further includes a plurality of apertures
formed on the plurality of external conduits.
[0017] According to another illustrative, non-limiting embodiment,
a method of manufacturing a medical manifold includes forming four
first conduits with each first conduit touching two other first
conduits, forming a second conduit from the four first conduits,
and using a core pin to create apertures in the first conduits and
the second conduit.
[0018] Other 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
[0019] The patent or application file contains at least one drawing
executed in color. Copies of this patent or patent application
publication with color drawing(s) will be provided by the Office
upon request and payment of the necessary fee.
[0020] FIG. 1 depicts a perspective view of a reduced-pressure
delivery apparatus according to an embodiment of the present
invention, the reduced-pressure delivery apparatus having a
plurality of projections extending from a flexible barrier to
create a plurality of flow channels;
[0021] FIG. 2 illustrates a front view of the reduced-pressure
delivery apparatus of FIG. 1;
[0022] FIG. 3 depicts a top view of the reduced-pressure delivery
apparatus of FIG. 1;
[0023] FIG. 4A illustrates a side view of the reduced-pressure
delivery apparatus of FIG. 1, the reduced-pressure delivery
apparatus having a single lumen, reduced-pressure delivery
tube;
[0024] FIG. 4B depicts a side view of an alternative embodiment of
the reduced-pressure delivery apparatus of FIG. 1, the
reduced-pressure delivery apparatus having a dual lumen,
reduced-pressure delivery tube;
[0025] FIG. 5 illustrates an enlarged perspective view of the
reduced-pressure delivery apparatus of FIG. 1;
[0026] FIG. 6 depicts a perspective view of a reduced-pressure
delivery apparatus according to an embodiment of the present
invention, the reduced-pressure delivery apparatus having a
cellular material attached to a flexible barrier having a spine
portion and a pair of wing portions, the cellular material having a
plurality of flow channels;
[0027] FIG. 7 illustrates a front view of the reduced-pressure
delivery apparatus of FIG. 6;
[0028] FIG. 8 depicts a cross-sectional side view of the
reduced-pressure delivery apparatus of FIG. 7 taken at
VIII-VIII;
[0029] FIG. 8A illustrates a cross-sectional front view of a
reduced-pressure delivery apparatus according to an embodiment of
the present invention;
[0030] FIG. 8B depicts a side view of the reduced-pressure delivery
apparatus of FIG. 8A;
[0031] FIG. 9 illustrates a front view of a reduced-pressure
delivery apparatus according to an embodiment of the present
invention being used to apply a reduced-pressure tissue treatment
to a bone of a patient;
[0032] FIG. 10 depicts a front view of a reduced-pressure delivery
system according to an embodiment of the present invention, the
reduced-pressure delivery system having a manifold delivery tube
that is used to percutaneously insert a reduced-pressure delivery
apparatus to a tissue site;
[0033] FIG. 11 illustrates an enlarged front view of the manifold
delivery tube of FIG. 10, the manifold delivery tube containing a
reduced-pressure delivery apparatus having a flexible barrier or a
cellular material in a compressed position;
[0034] FIG. 12 depicts an enlarged front view of the manifold
delivery tube of FIG. 11, the flexible barrier or cellular material
of the reduced-pressure delivery apparatus being shown in an
expanded position after having been pushed from the manifold
delivery tube;
[0035] FIG. 13 illustrates a front view of a reduced-pressure
delivery system according to an embodiment of the present
invention, the reduced-pressure delivery system having a manifold
delivery tube that is used to percutaneously insert a
reduced-pressure delivery apparatus to a tissue site, the
reduced-pressure delivery apparatus being shown outside of the
manifold delivery tube but constrained by an impermeable membrane
in a compressed position;
[0036] FIG. 14 depicts a front view of the reduced-pressure
delivery system of FIG. 13, the reduced-pressure delivery apparatus
being shown outside of the manifold delivery tube but constrained
by an impermeable membrane in a relaxed position;
[0037] FIG. 15 illustrates a front view of the reduced-pressure
delivery system of FIG. 13, the reduced-pressure delivery apparatus
being shown outside of the manifold delivery tube but constrained
by an impermeable membrane in an expanded position;
[0038] FIG. 15A illustrates a front view of the reduced-pressure
delivery system of FIG. 13, the reduced-pressure delivery apparatus
being shown outside of the manifold delivery tube but surrounded by
an impermeable membrane in an expanded position;
[0039] FIG. 16 depicts a front view of a reduced-pressure delivery
system according to an embodiment of the present invention, the
reduced-pressure delivery system having a manifold delivery tube
that is used to percutaneously insert a reduced-pressure delivery
apparatus to a tissue site, the reduced-pressure delivery apparatus
being shown outside of the manifold delivery tube but constrained
by an impermeable membrane having a glue seal;
[0040] FIG. 16A depicts a front view of a reduced-pressure delivery
system according to an embodiment of the present invention;
[0041] FIG. 17 illustrates a front view of a reduced-pressure
delivery system according to an embodiment of the present
invention, the reduced-pressure delivery system having a manifold
delivery tube that is used to percutaneously inject a
reduced-pressure delivery apparatus to a tissue site;
[0042] FIG. 17A illustrates a front view of a reduced-pressure
delivery system according to an embodiment of the present
invention, the reduced-pressure delivery system having a manifold
delivery tube that is used to percutaneously deliver a
reduced-pressure delivery apparatus to an impermeable membrane
positioned at a tissue site;
[0043] FIG. 18 depicts a flow chart of a method of administering a
reduced-pressure tissue treatment to a tissue site according to an
embodiment of the present invention;
[0044] FIG. 19 illustrates a flow chart of a method of
administering a reduced-pressure tissue treatment to a tissue site
according to an embodiment of the present invention;
[0045] FIG. 20 depicts a flow chart of a method of administering a
reduced-pressure tissue treatment to a tissue site according to an
embodiment of the present invention;
[0046] FIG. 21 illustrates a flow chart of a method of
administering a reduced-pressure tissue treatment to a tissue site
according to an embodiment of the present invention;
[0047] FIG. 22 depicts a cross-sectional front view of a
reduced-pressure delivery apparatus according to an embodiment of
the present invention, the reduced-pressure delivery apparatus
including a hip prosthesis having a plurality of flow channels for
applying a reduced pressure to an area of bone surrounding the hip
prosthesis;
[0048] FIG. 23 illustrates a cross-sectional front view of the hip
prosthesis of FIG. 22 having a second plurality of flow channels
for delivering a fluid to the area of bone surrounding the hip
prosthesis;
[0049] FIG. 24 depicts a flow chart of a method for repairing a
joint of a patient using reduced-pressure tissue treatment
according to an embodiment of the present invention;
[0050] FIG. 25 illustrates a cross-sectional front view of a
reduced-pressure delivery apparatus according to an embodiment of
the present invention, the reduced-pressure delivery apparatus
including a orthopedic fixation device having a plurality of flow
channels for applying a reduced pressure to an area of bone
adjacent the orthopedic fixation device;
[0051] FIG. 26 depicts a cross-sectional front view of the
orthopedic fixation device of FIG. 25 having a second plurality of
flow channels for delivering a fluid to the area of bone adjacent
the orthopedic fixation device;
[0052] FIG. 27 illustrates a flow chart of a method for healing a
bone defect of a bone using reduced-pressure tissue treatment
according to an embodiment of the present invention;
[0053] FIG. 28 depicts a flow chart of a method of administering a
reduced-pressure tissue treatment to a tissue site according to an
embodiment of the present invention;
[0054] FIG. 29 illustrates a flow chart of a method of
administering a reduced-pressure tissue treatment to a tissue site
according to an embodiment of the present invention;
[0055] FIGS. 30-38 depict various views of a reduced-pressure
delivery system according to an embodiment of the present
invention, the reduced-pressure delivery system having a primary
manifold that includes a flexible wall surrounding a primary flow
passage and a plurality of apertures in the flexible wall;
[0056] FIGS. 39-40 illustrate perspective and top cross-sectional
views of a reduced-pressure delivery system according to an
embodiment of the present invention, the reduced-pressure delivery
system having a primary manifold that is integrally connected to a
reduced-pressure delivery tube;
[0057] FIG. 41 is schematic, perspective view of a manifold
according to an illustrative embodiment;
[0058] FIG. 42 is a schematic, longitudinal cross-sectional view of
the manifold of FIG. 2; and
[0059] FIG. 43 is a schematic, lateral cross-sectional view of a
manifold according to another illustrative embodiment;
[0060] FIG. 44A is a schematic longitudinal cross-sectional view of
a manifold according to an illustrative embodiment;
[0061] FIG. 44B is a schematic, lateral cross-sectional view of the
manifold of FIG. 44A;
[0062] FIG. 45 is a schematic cross-sectional view of a manifold
according to an illustrative embodiment;
[0063] FIG. 46 is a schematic cross-sectional view of a manifold
according to an illustrative embodiment;
[0064] FIG. 47 depicts a perspective view of the primary manifolds
of FIGS. 30-40 being applied with a secondary manifold to a bone
tissue site;
[0065] FIG. 48 illustrates a schematic view of a reduced-pressure
delivery system having a valve fluidly connected to a second
conduit according to an embodiment of the present invention;
[0066] FIG. 49 is a schematic plan view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0067] FIG. 50 is a schematic side view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0068] FIG. 51 is a schematic plan view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0069] FIG. 52 is a schematic perspective view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0070] FIG. 53 is a schematic cross-sectional view of a manifold
according to an illustrative embodiment;
[0071] FIG. 54 is a schematic cross-sectional view of a manifold
according to an illustrative embodiment;
[0072] FIG. 55 is a schematic cross-sectional view of a transition
region according to an illustrative embodiment;
[0073] FIG. 56 is a schematic cross-sectional view of a delivery
tube according to an illustrative embodiment;
[0074] FIG. 57 is a schematic plan view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0075] FIG. 58 is a schematic perspective view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0076] FIG. 59 is a schematic cross-sectional view of a manifold
according to an illustrative embodiment;
[0077] FIG. 60 is a schematic cross-sectional view of a transition
region according to an illustrative embodiment;
[0078] FIG. 61 is a schematic cross-sectional view of a delivery
tube according to an illustrative embodiment;
[0079] FIG. 62 is a schematic perspective view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0080] FIG. 63 is a schematic perspective view of an apparatus for
applying reduced pressure to a subcutaneous tissue site according
to an illustrative embodiment;
[0081] FIG. 64 is a schematic perspective view of another
illustrative embodiment of a reduced pressure delivery
apparatus;
[0082] FIG. 65 is a schematic cross sectional view taken along line
65-65 in FIG. 64;
[0083] FIG. 66 is a schematic end view of the reduced pressure
delivery apparatus of FIGS. 64 and 65 showing an end cap;
[0084] FIG. 67 is a schematic perspective view of another
illustrative embodiment of a reduced pressure delivery
apparatus;
[0085] FIG. 68 is a schematic, perspective view of a portion of the
reduced pressure delivery apparatus of FIG. 67 with a portion
broken away to shown an interior portion;
[0086] FIG. 69 is a schematic, cross sectional view taken along
line 69-69 in FIG. 67; and
[0087] FIG. 70 is a schematic, plan view of the reduced pressure
delivery apparatus of FIGS. 67-69.
DETAILED DESCRIPTION
[0088] In the following detailed description of the preferred
embodiments, reference is made to the accompanying drawings that
form a part hereof, and in which is shown by way of illustration
specific preferred embodiments in which the invention may be
practiced. These embodiments are described in sufficient detail to
enable those skilled in the art to practice the invention, and it
is understood that other embodiments may be utilized and that
logical structural, mechanical, electrical, and chemical changes
may be made without departing from the spirit or scope of the
invention. To avoid detail not necessary to enable those skilled in
the art to practice the invention, the description may omit certain
information known to those skilled in the art. The following
detailed description is, therefore, not to be taken in a limiting
sense, and the scope of the present invention is defined only by
the appended claims.
[0089] As used herein, the term "elastomeric" means having the
properties of an elastomer. The term "elastomer" refers generally
to a polymeric material that has rubber-like properties. More
specifically, most elastomers have an ultimate elongation greater
than 100% and a significant amount of resilience. The resilience of
a material refers to the material's ability to recover from an
elastic deformation. Examples of elastomers may include, but are
not limited to, natural rubbers, polyisoprene, styrene butadiene
rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl
rubber, ethylene propylene rubber, ethylene propylene diene
monomer, chlorosulfonated polyethylene, polysulfide rubber,
polyurethane, and silicones.
[0090] As used herein, the term "flexible" refers to an object or
material that is able to be bent or flexed. Elastomeric materials
are typically flexible, but reference to flexible materials herein
does not necessarily limit material selection to only elastomers.
The use of the term "flexible" in connection with a material or
reduced-pressure delivery apparatus of the present invention
generally refers to the material's ability to conform to or closely
match the shape of a tissue site. For example, the flexible nature
of a reduced-pressure delivery apparatus used to treat a bone
defect may allow the apparatus to be wrapped or folded around the
portion of the bone having the defect.
[0091] The term "fluid" as used herein generally refers to a gas or
liquid, but may also include any other flowable material, including
but not limited to gels, colloids, and foams.
[0092] The term "impermeable" as used herein generally refers to
the ability of a membrane, cover, sheet, or other substance to
block or slow the transmission of either liquids or gas.
Impermeability may be used to refer to covers, sheets, or other
membranes that are resistant to the transmission of liquids, while
allowing gases to transmit through the membrane. While an
impermeable membrane may be liquid tight, the membrane may simply
reduce the transmission rate of all or only certain liquids. The
use of the term "impermeable" is not meant to imply that an
impermeable membrane is above or below any particular industry
standard measurement for impermeability, such as a particular value
of water vapor transfer rate (WVTR).
[0093] The term "manifold" as used herein generally refers to a
substance or structure that is provided to assist in applying
reduced pressure to, delivering fluids to, or removing fluids from
a tissue site. A manifold typically includes a plurality of flow
channels or pathways that are interconnected to improve
distribution of fluids provided to and removed from the area of
tissue around the manifold. Examples of manifolds may include
without limitation devices that have structural elements arranged
to form flow channels, cellular foam, such as open-cell foam,
porous tissue collections, and liquids, gels, and foams that
include or cure to include flow channels.
[0094] The term "reduced pressure" as used herein generally refers
to a pressure less than the ambient pressure at a tissue site that
is being subjected to treatment. In most cases, this reduced
pressure will be less than the atmospheric pressure at which the
patient is located. Alternatively, the reduced pressure may be less
than a hydrostatic pressure of tissue at the tissue site. Reduced
pressure may initially generate fluid flow in the tube and the area
of the tissue site. As the hydrostatic pressure around the tissue
site approaches the desired reduced pressure, the flow may subside,
and the reduced pressure is then maintained. Unless otherwise
indicated, values of pressure stated herein are gauge
pressures.
[0095] The term "scaffold" as used herein refers to a substance or
structure used to enhance or promote the growth of cells or the
formation of tissue. Unless otherwise indicated, "or" does not
require mutual exclusivity. A scaffold is typically a
three-dimensional porous structure that provides a template for
cell growth. The scaffold may be infused with, coated with, or
comprised of cells, growth factors, or other nutrients to promote
cell growth. A scaffold may be used as a manifold in accordance
with the embodiments described herein to administer
reduced-pressure tissue treatment to a tissue site.
[0096] The term "tissue site" as used herein refers to a wound or
defect located on or within any tissue, including but not limited
to, bone tissue, adipose tissue, muscle tissue, neural tissue,
dermal tissue, vascular tissue, connective tissue, cartilage,
tendons, or ligaments. The term "tissue site" may further refer to
areas of any tissue that are not necessarily wounded or defective,
but are instead areas in which it is desired to add or promote the
growth of additional tissue. For example, reduced-pressure tissue
treatment may be used in certain tissue areas to grow additional
tissue that may be harvested and transplanted to another tissue
location.
[0097] Referring primarily to FIGS. 1-5, a reduced-pressure
delivery apparatus, or wing manifold 211 according to the
principles of the present disclosure includes a flexible barrier
213 having a spine portion 215 and a pair of wing portions 219.
Each wing portion 219 is positioned along opposite sides of the
spine portion 215. The spine portion 215 forms an arcuate channel
223 that may or may not extend the entire length of the wing
manifold 211. Although the spine portion 215 may be centrally
located on the wing manifold 211 such that the width of the wing
portions 219 is equal, the spine portion 215 may also be offset as
illustrated in FIGS. 1-5, resulting in one of the wing portions 219
being wider than the other wing portion 219. The extra width of one
of the wing portions 219 may be particularly useful if the wing
manifold 211 is being used in connection with bone regeneration or
healing and the wider wing manifold 211 is to be wrapped around
fixation hardware attached to the bone.
[0098] The flexible barrier 213 is preferably formed by an
elastomeric material such as a silicone polymer. An example of a
suitable silicone polymer includes MED-6015 manufactured by Nusil
Technologies of Carpinteria, Calif. It should be noted, however,
that the flexible barrier 213 could be made from any other
biocompatible, flexible material. The flexible barrier 213 encases
a flexible backing 227 that adds strength and durability to the
flexible barrier 213. The thickness of the flexible barrier 213
encasing the flexible backing 227 may be less in the arcuate
channel 223 than that in the wing portions 219. If a silicone
polymer is used to form the flexible barrier 213, a silicone
adhesive may also be used to aid bonding with the flexible backing
227. An example of a silicone adhesive could include MED-1011, also
sold by Nusil Technologies. The flexible backing 227 is preferably
made from a polyester knit fabric, such as Bard 6013 manufactured
by C. R. Bard of Tempe, Ariz. However, the flexible backing 227
could be made from any biocompatible, flexible material that is
capable of adding strength and durability to the flexible barrier
213. Under certain circumstances, if the flexible barrier 213 is
made from a suitably strong material, the flexible backing 227
could be omitted.
[0099] It is preferred that either the flexible barrier 213 or the
flexible backing 227 be impermeable to liquids, air, and other
gases, or alternatively, both the flexible backing 227 and the
flexible barrier 213 may be impermeable to liquids, air, and other
gases.
[0100] The flexible barrier 213 and flexible backing 227 may also
be constructed from bioresorbable materials that do not have to be
removed from a patient's body following use of the wing manifold
211. Suitable bioresorbable materials may include, without
limitation, a polymeric blend of polylactic acid (PLA) and
polyglycolic acid (PGA). The polymeric blend may also include,
without limitation, polycarbonates, polyfumarates, and
capralactones. The flexible barrier 213 and the flexible backing
227 may further serve as a scaffold for new cell-growth, or a
scaffold material may be used in conjunction with the flexible
barrier 213 and flexible backing 227 to promote cell-growth.
Suitable scaffold material may include, without limitation, calcium
phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates,
or processed allograft materials. Preferably, the scaffold material
will have a high void-fraction (i.e., a high content of air).
[0101] In one embodiment the flexible backing 227 may be adhesively
attached to a surface of the flexible barrier 213. If a silicone
polymer is used to form the flexible barrier 213, a silicone
adhesive may also be used to attach the flexible backing 227 to the
flexible barrier 213. While an adhesive is the preferred method of
attachment when the flexible backing 227 is surface bonded to the
flexible barrier 213, any suitable attachment may be used.
[0102] The flexible barrier 213 includes a plurality of projections
231 extending from the wing portions 219 on a surface of the
flexible barrier 213. The projections 231 may be cylindrical,
spherical, hemispherical, cubed, or any other shape, as long as at
least some portion of each projection 231 is in a plane different
than the plane associated with the side of the flexible barrier 213
to which the projections 231 are attached. In this regard, a
particular projection 231 is not even required to have the same
shape or size as other projections 231; in fact, the projections
231 may include a random mix of different shapes and sizes.
Consequently, the distance by which each projection 231 extends
from the flexible barrier 213 could vary, but may also be uniform
among the plurality of projections 231.
[0103] The placement of projections 231 on the flexible barrier 213
creates a plurality of flow channels 233 between the projections.
When the projections 231 are of uniform shape and size and are
spaced uniformly on the flexible barrier 213, the flow channels 233
created between the projections 231 are similarly uniform.
Variations in the size, shape, and spacing of the projections 231
may be used to alter the size and flow characteristics of the flow
channels 233.
[0104] A reduced-pressure delivery tube 241 is positioned within
the arcuate channel 223 and is attached to the flexible barrier 213
as illustrated in FIG. 5. The reduced-pressure delivery tube 241
may be attached solely to the flexible barrier 213 or the flexible
backing 227, or the reduced-pressure delivery tube 241 could be
attached to both the flexible barrier 213 and the flexible backing
227. The reduced-pressure delivery tube 241 includes a distal
orifice 243 at a distal end of the reduced-pressure delivery tube
241. The reduced-pressure delivery tube 241 may be positioned such
that the distal orifice 243 is located at any point along the
arcuate channel 223, but the reduced-pressure delivery tube 241 is
preferably positioned such that the distal orifice 243 is located
approximately midway along the longitudinal length of the arcuate
channel 223. The distal orifice 243 is preferably made elliptical
or oval in shape by cutting the reduced-pressure delivery tube 241
along a plane that is oriented less than ninety (90) degrees to the
longitudinal axis of the tube 241. While the distal orifice 243 may
also be round, the elliptical shape of the distal orifice 243
increases fluid communication with the flow channels 233 formed
between the projections 231.
[0105] The reduced-pressure delivery tube 241 is preferably made
from paralyne-coated silicone or urethane. However, any
medical-grade tubing material may be used to construct the
reduced-pressure delivery tube 241. Other coatings that may coat
the tube include heparin, anti-coagulants, anti-fibrinogens,
anti-adherents, anti-thrombinogens, and hydrophilic coatings.
[0106] In one embodiment, the reduced-pressure delivery tube 241
may also include vent openings, or vent orifices 251 positioned
along the reduced-pressure delivery tube 241 as either an
alternative to the distal orifice 243 or in addition to the distal
orifice 243 to further increase fluid communication between the
reduced-pressure delivery tube 241 and the flow channels 233. The
reduced-pressure delivery tube 241 may be positioned along only a
portion of the longitudinal length of the arcuate channel 223 as
shown in FIGS. 1-5, or alternatively may be positioned along the
entire longitudinal length of the arcuate channel 223. If
positioned such that the reduced-pressure delivery tube 241
occupies the entire length of the arcuate channel 223, the distal
orifice 243 may be capped such that all fluid communication between
the tube 241 and the flow channels 233 occurs through the vent
orifices 251.
[0107] The reduced-pressure delivery tube 241 further includes a
proximal orifice 255 at a proximal end of the tube 241. The
proximal orifice 255 is configured to mate with a reduced-pressure
source, which is described in more detail below with reference to
FIG. 9. The reduced-pressure delivery tube 241 illustrated in FIGS.
1-3, 4A, and 5 includes only a single lumen, or passageway 259. It
is possible, however, for the reduced-pressure delivery tube 241 to
include multiple lumens, such as a dual lumen tube 261 illustrated
in FIG. 4B. The dual lumen tube 261 includes a first lumen 263 and
a second lumen 265. The use of a dual lumen tube provides separate
paths of fluid communication between the proximal end of the
reduced-pressure delivery tube 241 and the flow channels 233. For
example, the use of the dual lumen tube 261 may be used to allow
communication between the reduced-pressure source and the flow
channels 233 along the first lumen 263. The second lumen 265 may be
used to introduce a fluid to the flow channels 233. The fluid may
be filtered air or other gases, antibacterial agents, antiviral
agents, cell-growth promotion agents, irrigation fluids, chemically
active fluids, or any other fluid. If it is desired to introduce
multiple fluids to the flow channels 233 through separate fluid
communication paths, a reduced-pressure delivery tube may be
provided with more than two lumens.
[0108] Referring still to FIG. 4B, a horizontal divider 271
separates the first and second lumens 263, 265 of the
reduced-pressure delivery tube 241, resulting in the first lumen
263 being positioned above the second lumen 265. The relative
position of the first and second lumens 263, 265 may vary,
depending on how fluid communication is provided between the first
and second lumens 263, 265 and the flow channels 233. For example,
when the first lumen 263 is positioned as illustrated in FIG. 4B,
vent openings similar to vent openings 251 may be provided to allow
communication with the flow channels 233. When the second lumen 265
is positioned as illustrated in FIG. 4B, the second lumen 265 may
communicate with the flow channels 233 through a distal orifice
similar to distal orifice 243. Alternatively, the multiple lumens
of a reduced-pressure delivery tube could be positioned side by
side with a vertical divider separating the lumens, or the lumens
could be arranged concentrically or coaxially.
[0109] It should be apparent to a person having ordinary skill in
the art that the provision of independent paths of fluid
communication could be accomplished in a number of different ways,
including that of providing a multi-lumen tube as described above.
Alternatively, independent paths of fluid communication may be
provided by attaching a single lumen tube to another single lumen
tube, or by using separate, unattached tubes with single or
multiple lumens.
[0110] If separate tubes are used to provide separate paths of
fluid communication to the flow channels 233, the spine portion 215
may include multiple arcuate channels 223, one for each tube.
Alternatively the arcuate channel 223 may be enlarged to
accommodate multiple tubes. An example of a reduced-pressure
delivery apparatus having a reduced-pressure delivery tube separate
from a fluid delivery tube is discussed in more detail below with
reference to FIG. 9.
[0111] Referring primarily to FIGS. 6-8, a reduced-pressure
delivery apparatus, or wing manifold 311 according to the
principles of the present disclosure includes a flexible barrier
313 having a spine portion 315 and a pair of wing portions 319.
Each wing portion 319 is positioned along opposite sides of the
spine portion 315. The spine portion 315 forms an arcuate channel
323 that may or may not extend the entire length of the wing
manifold 311. Although the spine portion 315 may be centrally
located on the wing manifold 311 such that the size of the wing
portions 319 is equal, the spine portion 315 may also be offset as
illustrated in FIGS. 6-8, resulting in one of the wing portions 319
being wider than the other wing portion 319. The extra width of one
of the wing portions 319 may be particularly useful if the wing
manifold 311 is being used in connection with bone regeneration or
healing and the wider wing manifold 311 is to be wrapped around
fixation hardware attached to the bone.
[0112] A cellular material 327 is attached to the flexible barrier
313 and may be provided as a single piece of material that covers
the entire surface of the flexible barrier 313, extending across
the spine portion 315 and both wing portions 319. The cellular
material 327 includes an attachment surface (not visible in FIG. 6)
that is disposed adjacent to the flexible barrier 313, a main
distribution surface 329 opposite the attachment surface, and a
plurality of perimeter surfaces 330.
[0113] In one embodiment the flexible barrier 313 may be similar to
flexible barrier 213 and include a flexible backing. While an
adhesive is a preferred method of attaching the cellular material
327 to the flexible barrier 313, the flexible barrier 313 and
cellular material 327 could be attached by any other suitable
attachment method or left for the user to assemble at the site of
treatment. The flexible barrier 313 or flexible backing serve as an
impermeable barrier to transmission of fluids, such as liquids,
air, and other gases.
[0114] In one embodiment, a flexible barrier and flexible backing
may not be separately provided to back the cellular material 327.
Rather, the cellular material 327 may have an integral barrier
layer that is an impermeable portion of the cellular material 327.
The barrier layer could be formed from closed-cell material to
prevent transmission of fluids, thereby substituting for the
flexible barrier 313. If an integral barrier layer is used with the
cellular material 327, the barrier layer may include a spine
portion and wing portions as described previously with reference to
the flexible barrier 313.
[0115] The flexible barrier 313 is preferably made from an
elastomeric material, such as a silicone polymer. An example of a
suitable silicone polymer includes MED-6015 manufactured by Nusil
Technologies of Carpinteria, Calif. It should be noted, however,
that the flexible barrier 313 could be made from any other
biocompatible, flexible material. If the flexible barrier encases
or otherwise incorporates a flexible backing, the flexible backing
is preferably made from a polyester knit fabric such as Bard 6013
manufactured by C. R. Bard of Tempe, Ariz. However, the flexible
backing could be made from any biocompatible, flexible material
that is capable of adding strength and durability to the flexible
barrier 313.
[0116] In one embodiment, the cellular material 327 is an
open-cell, reticulated polyetherurethane foam with pore sizes
ranging from about 400-600 microns. An example of this foam may
include GranuFoam.RTM. material manufactured by Kinetic Concepts,
Inc. of San Antonio, Tex. The cellular material 327 may also be
gauze, felted mats, or any other biocompatible material that
provides fluid communication through a plurality of channels in
three dimensions.
[0117] The cellular material 327 is primarily an "open cell"
material that includes a plurality of cells fluidly connected to
adjacent cells. A plurality of flow channels is formed by and
between the "open cells" of the cellular material 327. The flow
channels allow fluid communication throughout that portion of the
cellular material 327 having open cells. The cells and flow
channels may be uniform in shape and size, or may include patterned
or random variations in shape and size. Variations in shape and
size of the cells of the cellular material 327 result in variations
in the flow channels, and such characteristics can be used to alter
the flow characteristics of fluid through the cellular material
327. The cellular material 327 may further include portions that
include "closed cells." These closed-cell portions of the cellular
material 327 contain a plurality of cells, the majority of which
are not fluidly connected to adjacent cells. An example of a
closed-cell portion is described above as a barrier layer that may
be substituted for the flexible barrier 313. Similarly, closed-cell
portions could be selectively disposed in the cellular material 327
to prevent transmission of fluids through the perimeter surfaces
330 of the cellular material 327.
[0118] The flexible barrier 313 and cellular material 327 may also
be constructed from bioresorbable materials that do not have to be
removed from a patient's body following use of the reduced-pressure
delivery apparatus 311. Suitable bioresorbable materials may
include, without limitation, a polymeric blend of polylactic acid
(PLA) and polyglycolic acid (PGA). The polymeric blend may also
include without limitation polycarbonates, polyfumarates, and
capralactones. The flexible barrier 313 and the cellular material
327 may further serve as a scaffold for new cell-growth, or a
scaffold material may be used in conjunction with the flexible
barrier 313, flexible backing, or cellular material 327 to promote
cell-growth. Suitable scaffold materials may include, without
limitation, calcium phosphate, collagen, PLA/PGA, coral hydroxy
apatites, carbonates, or processed allograft materials. Preferably,
the scaffold material will have a high void-fraction (i.e. a high
content of air).
[0119] A reduced-pressure delivery tube 341 is positioned within
the arcuate channel 323 and is attached to the flexible barrier
313. The reduced-pressure delivery tube 341 may also be attached to
the cellular material 327, or in the case of only a cellular
material 327 being present, the reduced-pressure delivery tube 341
may be attached to only the cellular material 327. The
reduced-pressure delivery tube 341 includes a distal orifice 343 at
a distal end of the reduced-pressure delivery tube 341 similar to
the distal orifice 243 of FIG. 5. The reduced-pressure delivery
tube 341 may be positioned such that the distal orifice 343 is
located at any point along the arcuate channel 323, but is
preferably located approximately midway along the longitudinal
length of the arcuate channel 323. The distal orifice 343 is
preferably made elliptical or oval in shape by cutting the
reduced-pressure delivery tube 341 along a plane that is oriented
less than ninety (90) degrees to the longitudinal axis of the
reduced-pressure delivery tube 341. While the orifice may also be
round, the elliptical shape of the orifice increases fluid
communication with the flow channels in the cellular material
327.
[0120] In one embodiment, the reduced-pressure delivery tube 341
may also include vent openings, or vent orifices (not shown)
similar to vent openings 251 of FIG. 5. The vent openings are
positioned along the reduced-pressure delivery tube 341 as either
an alternative to the distal orifice 343 or in addition to the
distal orifice 343 to further increase fluid communication between
the reduced-pressure delivery tube 341 and the flow channels. As
previously described, the reduced-pressure delivery tube 341 may be
positioned along only a portion of the longitudinal length of the
arcuate channel 323, or alternatively may be positioned along the
entire longitudinal length of the arcuate channel 323. If
positioned such that the reduced-pressure delivery tube 341
occupies the entire arcuate channel 323, the distal orifice 343 may
be capped such that all fluid communication between the
reduced-pressure delivery tube 341 and the flow channels occurs
through the vent openings.
[0121] Preferably, the cellular material 327 overlays and directly
contacts the reduced-pressure delivery tube 341. The cellular
material 327 may be connected to the reduced-pressure delivery tube
341, or the cellular material 327 may simply be attached to the
flexible barrier 313. If the reduced-pressure delivery tube 341 is
positioned such that it only extends to a midpoint of the arcuate
channel 323, the cellular material 327 may also be connected to the
spine portion 315 of the flexible barrier 313 in that area of the
arcuate channel 323 that does not contain the reduced-pressure
delivery tube 341.
[0122] The reduced-pressure delivery tube 341 further includes a
proximal orifice 355 at a proximal end of the reduced-pressure
delivery tube 341. The proximal orifice 355 is configured to mate
with a reduced-pressure source, which is described in more detail
below with reference to FIG. 9. The reduced-pressure delivery tube
341 illustrated in FIGS. 6-8 includes only a single lumen, or
passageway 359. It is possible, however, for the reduced-pressure
delivery tube 341 to include multiple lumens such as those
described previously with reference to FIG. 4B. The use of a
multiple lumen tube provides separate paths of fluid communication
between the proximal end of the reduced-pressure delivery tube 341
and the flow channels as previously described. These separate paths
of fluid communication may also be provided by separate tubes
having single or multiple lumens that communicate with the flow
channels.
[0123] Referring primarily to FIGS. 8A and 8B, a reduced-pressure
delivery apparatus 371 according to the principles of the present
disclosure includes a reduced-pressure delivery tube 373 having an
extension portion 375 at a distal end 377 of the reduced-pressure
delivery tube 373. The extension portion 375 is preferably
arcuately shaped to match the curvature of the reduced-pressure
delivery tube 373. The extension portion 375 may be formed by
removing a portion of the reduced-pressure delivery tube 373 at the
distal end 377, thereby forming a cut-out 381 having a shoulder
383. A plurality of projections 385 is disposed on an inner surface
387 of the reduced-pressure delivery tube 373 to form a plurality
of flow channels 391 between the projections 385. The projections
385 may be similar in size, shape, and spacing as the projections
described with reference to FIGS. 1-5. The reduced-pressure
delivery apparatus 371 is particularly suited for applying reduced
pressure to and regenerating tissue on connective tissues that are
capable of being received within the cut-out 381. Ligaments,
tendons, and cartilage are non-limiting examples of the tissues
that may be treated by reduced-pressure delivery apparatus 371.
[0124] Referring primarily to FIG. 9, a reduced-pressure delivery
apparatus 411 similar to the other reduced-pressure delivery
apparatuses described herein is used to apply a reduced-pressure
tissue treatment to a tissue site 413, such as a human bone 415 of
a patient. When used to promote bone tissue growth,
reduced-pressure tissue treatment can increase the rate of healing
associated with a fracture, a non-union, a void, or other bone
defects. It is further believed that reduced-pressure tissue
treatment may be used to improve recovery from osteomyelitis. The
therapy may further be used to increase localized bone densities in
patients suffering from osteoporosis. Finally, reduced-pressure
tissue treatment may be used to speed and improve oseointegration
of orthopedic implants such as hip implants, knee implants, and
fixation devices.
[0125] Referring still to FIG. 9, the reduced-pressure delivery
apparatus 411 includes a reduced-pressure delivery tube 419 having
a proximal end 421 fluidly connected to a reduced-pressure source
427. The reduced-pressure source 427 is a pump or any other device
that is capable of applying a reduced pressure to the tissue site
413 through the reduced-pressure delivery tube 419 and a plurality
of flow channels associated with the reduced-pressure delivery
apparatus 411. Applying reduced pressure to the tissue site 413 is
accomplished by placing the wing portions of the reduced-pressure
delivery apparatus 411 adjacent the tissue site 413, which in this
particular example involves wrapping the wing portions around a
void defect 429 in the bone 415. The reduced-pressure delivery
apparatus 411 may be surgically or percutaneously inserted. When
percutaneously inserted, the reduced-pressure delivery tube 419 is
preferably inserted through a sterile insertion sheath that
penetrates the skin tissue of the patient.
[0126] The application of reduced-pressure tissue treatment
typically generates granulation tissue in the area surrounding the
tissue site 413. Granulation tissue is a common tissue that often
forms prior to tissue repair in the body. Under normal
circumstances, granulation tissue may form in response to a foreign
body or during wound healing. Granulation tissue typically serves
as a scaffold for healthy replacement tissue and further results in
the development of some scar tissue. Granulation tissue is highly
vascularized, and the increased growth and growth rate of the
highly vascularized tissue in the presence of reduced pressure
promotes new tissue growth at the tissue site 413.
[0127] Referring still to FIG. 9, a fluid delivery tube 431 may be
fluidly connected at a distal end to the flow channels of the
reduced-pressure delivery apparatus 411. The fluid delivery tube
431 includes a proximal end 432 that is fluidly connected to a
fluid delivery source 433. If the fluid being delivered to the
tissue site is air, the air is preferably filtered by a filter 434
capable of filtering particles at least as small as 0.22 .mu.m in
order to clean and sterilize the air. The introduction of air to
the tissue site 413, especially when the tissue site 413 is located
beneath the surface of the skin, is important to facilitate good
drainage of the tissue site 413, thereby reducing or preventing
obstruction of the reduced-pressure delivery tube 419. The fluid
delivery tube 431 and fluid delivery source 433 could also be used
to introduce other fluids to the tissue site 413, including without
limitation an antibacterial agent, an antiviral agent, a
cell-growth promotion agent, an irrigation fluid, or other
chemically active agents. When percutaneously inserted, the fluid
delivery tube 431 is preferably inserted through a sterile
insertion sheath that penetrates the skin tissue of the
patient.
[0128] A pressure sensor 435 may be operably connected to the fluid
delivery tube 431 to indicate whether the fluid delivery tube 431
is occluded with blood or other bodily fluids. The pressure sensor
435 may be operably connected to the fluid delivery source 433 to
provide feedback so that the amount of fluid introduced to the
tissue site 413 is controlled. A check valve (not shown) may also
be operably connected near the distal end of the fluid delivery
tube 431 to prevent blood or other bodily fluids from entering the
fluid delivery tube 431.
[0129] The independent paths of fluid communication provided by
reduced-pressure delivery tube 419 and fluid delivery tube 431 may
be accomplished in a number of different ways, including that of
providing a single, multi-lumen tube as described previously with
reference to FIG. 4B. A person of ordinary skill in the art will
recognize that the sensors, valves, and other components associated
with the fluid delivery tube 431 could also be similarly associated
with a particular lumen in the reduced-pressure delivery tube 419
if a multi-lumen tube is used. It is preferred that any lumen or
tube that fluidly communicates with the tissue site be coated with
an anti-coagulant to prevent a build-up of bodily fluids or blood
within the lumen or tube. Other coatings that may coat the lumens
or tubes include without limitation heparin, anti-coagulants,
anti-fibrinogens, anti-adherents, anti-thrombinogens, and
hydrophilic coatings.
[0130] Referring primarily to FIG. 10, a reduced-pressure delivery
system 711 according to an embodiment of the present disclosure
delivers reduced-pressure tissue treatment to a tissue site 713 of
a patient. The reduced-pressure delivery system 711 includes a
manifold delivery tube 721. The manifold delivery tube 721 may be a
catheter or cannula and may include features, such as a steering
unit 725 and a guide wire 727 that allow the manifold delivery tube
721 to be guided to the tissue site 713. Placement and direction of
the guide wire 727 and the manifold delivery tube 721 may be
accomplished by using endoscopy, ultrasound, fluoroscopy,
auscultation, palpation, or any other suitable localization
technique. The manifold delivery tube 721 is provided to
percutaneously insert a reduced-pressure delivery apparatus to the
tissue site 713 of the patient. When percutaneously inserted, the
manifold delivery tube 721 is preferably inserted through a sterile
insertion sheath that penetrates the skin tissue of the
patient.
[0131] In FIG. 10, the tissue site 713 includes bone tissue
adjacent a fracture 731 on a bone 733 of the patient. The manifold
delivery tube 721 is inserted through the patient's skin 735 and
any soft tissue 739 surrounding the bone 733. As previously
discussed, the tissue site 713 may also include any other type of
tissue, including, without limitation, adipose tissue, muscle
tissue, neural tissue, dermal tissue, vascular tissue, connective
tissue, cartilage, tendons, or ligaments.
[0132] Referring primarily to FIGS. 11 and 12, the reduced-pressure
delivery system 711 is further illustrated. The manifold delivery
tube 721 may include a tapered distal end 743 to ease insertion
through the patient's skin 735 and soft tissue 739 in FIG. 10. The
tapered distal end 743 may further be configured to flex radially
outward to an open position such that the inner diameter of the
tapered distal end 743 would be substantially the same as or
greater than the inner diameter at other portions of the tube 721.
The open position of the tapered distal end 743 is schematically
illustrated in FIG. 11 by broken lines 737.
[0133] The manifold delivery tube 721 further includes a passageway
751 in which a reduced-pressure delivery apparatus 761, or any
other reduced-pressure delivery apparatus, is contained. The
reduced-pressure delivery apparatus 761 includes a flexible barrier
765 or cellular material 767 similar to that described with
reference to FIGS. 6-8. The flexible barrier 765 or cellular
material 767 is preferably rolled, folded, or otherwise compressed
around a reduced-pressure delivery tube 769 to reduce the
cross-sectional area of the reduced-pressure delivery apparatus 761
within the passageway 751.
[0134] The reduced-pressure delivery apparatus 761 may be placed
within the passageway 751 and guided to the tissue site 713
following the placement of the tapered distal end 743 manifold
delivery tube 721 at the tissue site 713. Alternatively, the
reduced-pressure delivery apparatus 761 may be pre-positioned
within the passageway 751 prior to the manifold delivery tube 721
being inserted into the patient. If the reduced-pressure delivery
apparatus 761 is to be pushed through the passageway 751, a
biocompatible lubricant may be used to reduce friction between the
reduced-pressure delivery apparatus 761 and the manifold delivery
tube 721. When the tapered distal end 743 has been positioned at
the tissue site 713 and the reduced-pressure delivery apparatus 761
has been delivered to the tapered distal end 743, the
reduced-pressure delivery apparatus 761 is then pushed toward the
tapered distal end 743, causing the tapered distal end 743 to
expand radially outward into the open position. The
reduced-pressure delivery apparatus 761 is pushed out of the
manifold delivery tube 721, preferably into a void or space
adjacent the tissue site 713. The void or space is typically formed
by dissection of soft tissue, which may be accomplished by
percutaneous means. In some cases, the tissue site 713 may be
located at a wound site, and a void may be naturally present due to
the anatomy of the wound. In other instances, the void may be
created by balloon dissection, sharp dissection, blunt dissection,
hydrodissection, pneumatic dissection, ultrasonic dissection,
electrocautery dissection, laser dissection, or any other suitable
dissection technique. When the reduced-pressure delivery apparatus
761 enters the void adjacent the tissue site 713, the flexible
barrier 765 or cellular material 767 of the reduced-pressure
delivery apparatus 761 either unrolls, unfolds, or decompresses
(see FIG. 12) such that the reduced-pressure delivery apparatus 761
can be placed in contact with the tissue site 713. Although not
required, the flexible barrier 765 or cellular material 767 may be
subjected to a vacuum or reduced pressure supplied through the
reduced-pressure delivery tube 769 to compress the flexible barrier
765 or cellular material 767. The unfolding of the flexible barrier
765 or cellular material 767 may be accomplished by either relaxing
the reduced pressure supplied through the reduced-pressure delivery
tube 769 or by supplying a positive pressure through the
reduced-pressure delivery tube 769 to assist the unrolling process.
Final placement and manipulation of the reduced-pressure delivery
apparatus 761 may be accomplished by using endoscopy, ultrasound,
fluoroscopy, auscultation, palpation, or any other suitable
localization technique. Following placement of the reduced-pressure
delivery apparatus 761, the manifold delivery tube 721 is
preferably removed from the patient, but the reduced-pressure
delivery tube associated with reduced-pressure delivery apparatus
761 remains in situ to allow percutaneous application of reduced
pressure to the tissue site 713.
[0135] Referring primarily to FIGS. 13-15, a reduced-pressure
delivery system 811 according to an embodiment of the present
disclosure includes a manifold delivery tube 821 having a tapered
distal end 843 that is configured to flex radially outward to an
open position such that the inner diameter of the distal end 843
would be substantially the same as or greater than the inner
diameter at other portions of the manifold delivery tube 821. The
open position of the distal end 843 is schematically illustrated in
FIGS. 13-15 by broken lines 837.
[0136] The manifold delivery tube 821 further includes a passageway
in which a reduced-pressure delivery apparatus 861 similar to the
other reduced-pressure delivery apparatuses described herein is
contained. The reduced-pressure delivery apparatus 861 includes a
flexible barrier 865 or a cellular material 867 that is preferably
rolled, folded, or otherwise compressed around a reduced-pressure
delivery tube 869 to reduce the cross-sectional area of the
reduced-pressure delivery apparatus 861 within the passageway.
[0137] An impermeable membrane 871 having an inner space 873 is
disposed around the reduced-pressure delivery apparatus 861 such
that the reduced-pressure delivery apparatus 861 is contained
within the inner space 873 of the impermeable membrane 871. The
impermeable membrane 871 may be a balloon, a sheath, or any other
type of membrane that is capable of preventing fluid transmission
such that the impermeable membrane 871 can assume at least one of a
compressed position (see FIG. 13), a relaxed position (see FIG.
14), and an expanded position (see FIGS. 15 and 15A). The
impermeable membrane 871 may be sealingly connected to the manifold
delivery tube 821 such that the inner space 873 of the impermeable
membrane 871 is in fluid communication with the passageway of the
manifold delivery tube 821. The impermeable membrane 871 may
alternatively be attached to the reduced-pressure delivery tube 869
such that the inner space 873 of the impermeable membrane 871 is in
fluid communication with the passageway of the reduced-pressure
delivery tube 869. The impermeable membrane 871 instead may be
attached to a separate control tube or control lumen (see for
example FIG. 15A) that fluidly communicates with the inner space
873.
[0138] In one embodiment, the impermeable membrane 871 may be
provided to further reduce the cross-sectional area of the
reduced-pressure delivery apparatus 861 within the passageway. To
accomplish this, a pressure is applied to the inner space 873 of
the impermeable membrane 871 that is less than the ambient pressure
surrounding the impermeable membrane 871. A significant portion of
the air or other fluid within the inner space 873 is thereby
evacuated, placing the impermeable membrane 871 in the compressed
position illustrated in FIG. 13. In the compressed position, the
impermeable membrane 871 is drawn inward such that a compressive
force is applied to the reduced-pressure delivery apparatus 861 to
further reduce the cross-sectional area of the reduced-pressure
delivery apparatus 861. As previously described with reference to
FIGS. 11 and 12, the reduced-pressure delivery apparatus 861 may be
delivered to the tissue site following the placement of the distal
end 843 of the manifold delivery tube 821 at the tissue site.
Placement and manipulation of the impermeable membrane 871 and the
reduced-pressure delivery apparatus 861 may be accomplished by
using endoscopy, ultrasound, fluoroscopy, auscultation, palpation,
or any other suitable localization technique. The impermeable
membrane 871 may include radio-opaque markers 881 that improve
visualization of the impermeable membrane 871 under fluoroscopy
prior to its removal.
[0139] After pushing the reduced-pressure delivery apparatus 861
through the distal end 843, the reduced pressure applied to the
inner space 873 may be eased to place the impermeable membrane 871
in the relaxed position (see FIG. 14), thereby facilitating easier
removal of the reduced-pressure delivery apparatus 861 from the
impermeable membrane 871. A removal instrument 885, such as a
trocar, stylet, or other sharp instrument may be provided to
rupture the impermeable membrane 871. Preferably, the removal
instrument 885 is inserted through the reduced-pressure delivery
tube 869 and is capable of being advanced into contact with the
impermeable membrane 871. After rupture of the impermeable membrane
871, the removal instrument 885 and the impermeable membrane 871
may be withdrawn through the manifold delivery tube 821, allowing
the flexible barrier 865 or cellular material 867 of the
reduced-pressure delivery apparatus 861 to unroll, unfold, or
decompress such that the reduced-pressure delivery apparatus 861
can be placed in contact with the tissue site. The unrolling of the
flexible barrier 865 or cellular material 867 may occur
automatically following the relaxation of reduced pressure to the
inner space 873 and the removal of the impermeable membrane 871. In
some cases, a positive pressure may be delivered through the
reduced-pressure delivery tube 869 to assist in unrolling or
decompressing the flexible barrier 865 or cellular material 867.
Following final placement of the reduced-pressure delivery
apparatus 861, the manifold delivery tube 821 is preferably removed
from the patient, but the reduced-pressure delivery tube 869
associated with the reduced-pressure delivery apparatus 861 remains
in situ to allow percutaneous application of reduced pressure to
the tissue site.
[0140] The impermeable membrane 871 may also be used to dissect
tissue adjacent the tissue site prior to placing the
reduced-pressure delivery apparatus 861 against the tissue site.
After pushing the reduced-pressure delivery apparatus 861 and
intact impermeable membrane 871 through the distal end 843 of the
manifold delivery tube 821, air or another fluid may be injected or
pumped into the inner space 873 of the impermeable membrane 871. A
liquid is preferably used to inflate the impermeable membrane 871
since the incompressibility of liquids allow the impermeable
membrane 871 to expand more evenly and consistently. The
impermeable membrane 871 may expand radially as illustrated in FIG.
15 or directionally depending on its method of manufacture and
attachment to the manifold delivery tube 821. As the impermeable
membrane 871 expands outward into the expanded position (see FIG.
15) due to the pressure of the air or fluid, a void is dissected
adjacent the tissue site. When the void is large enough, the
liquid, air or other fluid may be released from the inner space 873
to allow the impermeable membrane 871 to assume the relaxed
position. The impermeable membrane 871 may then be ruptured as
previously explained and the reduced-pressure delivery apparatus
861 inserted adjacent the tissue site.
[0141] Referring primarily to FIG. 15A, if the impermeable membrane
871 is used primarily to dissect tissue adjacent the tissue site,
the impermeable membrane 871 may be sealingly attached to the
manifold delivery tube 821 such that the inner space 873 fluidly
communicates with a secondary lumen, or tube 891, associated with
or attached to the manifold delivery tube 821. The secondary lumen
891 may be used to deliver a liquid, air, or other fluid to the
inner space 873 to place the impermeable membrane 871 in the
expanded position. Following dissection, the impermeable membrane
871 may be relaxed and ruptured as previously described with
reference to FIG. 14.
[0142] Referring primarily to FIG. 16, a reduced-pressure delivery
system 911 according to an embodiment of the present disclosure
includes a manifold delivery tube 921 having a tapered distal end
943 that is configured to flex radially outward to an open position
such that the inner diameter of the distal end 943 would be
substantially the same as or greater than the inner diameter at
other portions of the manifold delivery tube 921. The open position
of the distal end 943 is schematically illustrated in FIG. 16 by
broken lines 937.
[0143] The manifold delivery tube 921 further includes a passageway
in which a reduced-pressure delivery apparatus 961 similar to the
other reduced-pressure delivery apparatuses described herein is
contained. The reduced-pressure delivery apparatus 961 includes a
flexible barrier 965 or a cellular material 967 that is preferably
rolled, folded, or otherwise compressed around a reduced-pressure
delivery tube 969 to reduce the cross-sectional area of the
reduced-pressure delivery apparatus 961 within the passageway of
the manifold delivery tube 921.
[0144] An impermeable membrane 971 having an inner space 973 is
disposed around the reduced-pressure delivery apparatus 961 such
that the reduced-pressure delivery apparatus 961 is contained
within the inner space 973 of the impermeable membrane 971. The
impermeable membrane 971 includes a glue seal 977 on one end of the
impermeable membrane 971 to provide an alternative method of
removing the reduced-pressure delivery apparatus 961 from the
impermeable membrane 971. The impermeable membrane 971 may be
sealingly connected at another end to the manifold delivery tube
921 such that the inner space 973 of the impermeable membrane 971
is in fluid communication with the passageway of the manifold
delivery tube 921. Alternatively, the impermeable membrane 971 may
be attached to a separate control tube (not shown) that fluidly
communicates with the inner space 973.
[0145] Similar to the impermeable membrane 871 of FIG. 13,
impermeable membrane 971 may be capable of preventing fluid
transmission such that the impermeable membrane 971 can assume at
least one of a compressed position, a relaxed position, and an
expanded position. Since the procedures for placing the impermeable
membrane 971 in a compressed position and an expanded position are
similar to those for impermeable membrane 871, only the differing
process of removing the reduced-pressure delivery apparatus 961 is
described.
[0146] The reduced-pressure delivery apparatus 961 is delivered to
the tissue site within the impermeable membrane 971 and then
properly positioned using endoscopy, ultrasound, fluoroscopy,
auscultation, palpation, or any other suitable localization
technique. The impermeable membrane 971 may include radio-opaque
markers 981 that improve visualization of the impermeable membrane
971 under fluoroscopy prior to its removal. The reduced-pressure
delivery apparatus 961 is then pushed through the distal end 943 of
the manifold delivery tube 921. The reduced pressure applied to the
inner space 973 may be eased to place the impermeable membrane 971
in the relaxed position. The reduced-pressure delivery apparatus
961 is then pushed through the glue seal 977 to exit the
impermeable membrane 971.
[0147] Referring primarily to FIG. 16A, a reduced-pressure delivery
system 985 according to an embodiment of the present disclosure may
not include a manifold delivery tube similar to manifold delivery
tube 921 of FIG. 16. Instead, the reduced-pressure delivery system
985 may include a guide wire 987, a reduced-pressure delivery tube
989, and a reduced-pressure delivery apparatus 991. The
reduced-pressure delivery apparatus 991 includes a plurality flow
channels that is fluidly connected to the reduced-pressure delivery
tube 989. Instead of using an independent manifold delivery tube to
deliver the reduced-pressure delivery apparatus 991, the
reduced-pressure delivery apparatus 991 and reduced-pressure
delivery tube 989 are placed on the guide wire 987, which is
percutaneously guided to a tissue site 993. Preferably, the guide
wire 987 and reduced-pressure delivery tube 989 penetrate the skin
of the patient through a sterile sheath. By guiding the
reduced-pressure delivery tube 989 and reduced-pressure delivery
apparatus 991 along the guide wire 987, the reduced-pressure
delivery apparatus 991 may be placed at the tissue site 993 to
allow percutaneous application of reduced-pressure tissue
treatment.
[0148] Since the reduced-pressure delivery apparatus 991 is not
constrained within a manifold delivery tube during delivery to the
tissue site 993, it is preferable to hold the reduced-pressure
delivery apparatus 991 in a compressed position during delivery. If
an elastic foam is used as the reduced-pressure delivery apparatus
991, a biocompatible, soluble adhesive may be applied to the foam
and the foam compressed. Upon arrival at the tissue site, bodily
fluids or other fluids delivered through the reduced-pressure
delivery tube 989 dissolve the adhesive, allowing the foam to
expand into contact with the tissue site. Alternatively, the
reduced-pressure delivery apparatus 991 may be formed from a
compressed, dry hydrogel. The hydrogel absorbs moisture following
delivery to the tissue site 993 allowing expansion of the
reduced-pressure delivery apparatus 991. Still another
reduced-pressure delivery apparatus 991 may be made from a
thermoactive material (e.g., polyethylene glycol) that expands at
the tissue site 993 when exposed to the body heat of the patient.
In still another embodiment, a compressed reduced-pressure delivery
apparatus 991 may be delivered to the tissue site 993 in a
dissolvable membrane.
[0149] Referring primarily to FIG. 17, a reduced-pressure delivery
system 1011 according to an embodiment of the present disclosure
includes a manifold delivery tube 1021 having a distal end 1043
that is inserted through a tissue of a patient to access a tissue
site 1025. The tissue site 1025 may include a void 1029 that is
associated with a wound or other defect, or alternatively a void
may be created by dissection, including the dissection techniques
described herein.
[0150] Following placement of the distal end 1043 within the void
1029 adjacent the tissue site 1025, an injectable, pourable, or
flowable reduced-pressure delivery apparatus 1035 is delivered
through the manifold delivery tube 1021 to the tissue site 1025.
The reduced-pressure delivery apparatus 1035 preferably exists in a
flowable state during delivery to the tissue site, and then, after
arrival forms a plurality of flow channels for distribution of
reduced pressure or fluids. In some cases, the flowable material
may harden into a solid state after arrival at the tissue site,
either through a drying process, a curing process, or other
chemical or physical reaction. In other cases, the flowable
material may form a foam in situ following delivery to the tissue
site. Still other materials may exist in a gel-like state at the
tissue site 1025 but still have a plurality of flow channels for
delivering reduced pressure. The amount of reduced-pressure
delivery apparatus 1035 delivered to the tissue site 1025 may be
enough to partially or completely fill the void 1029. The
reduced-pressure delivery apparatus 1035 may include aspects of
both a manifold and a scaffold. As a manifold, the reduced-pressure
delivery apparatus 1035 includes a plurality of pores or open cells
that may be formed in the material after delivery to the void 1029.
The pores or open cells communicate with one another, thereby
creating a plurality of flow channels. The flow channels are used
to apply and distribute reduced pressure to the tissue site 1025.
As a scaffold, the reduced-pressure delivery apparatus 1035 is
bioresorbable and serves as a substrate upon and within which new
tissue may grow.
[0151] In one embodiment, the reduced-pressure delivery apparatus
1035 may include poragens, such as NaCl or other salts that are
distributed throughout a liquid or viscous gel. After the liquid or
viscous gel is delivered to the tissue site 1025, the material
conforms to the void 1029 and then cures into a solid mass. The
water-soluble NaCl poragens dissolve in the presence of bodily
fluids leaving a structure with interconnected pores, or flow
channels. Reduced pressure or fluid is delivered to the flow
channels. As new tissue develops, the tissue grows into the pores
of the reduced-pressure delivery apparatus 1035, and then
ultimately replaces the reduced-pressure delivery apparatus 1035 as
it degrades. In this particular example, the reduced-pressure
delivery apparatus 1035 serves not only as a manifold, but also as
a scaffold for new tissue growth.
[0152] In another embodiment, the reduced-pressure delivery
apparatus 1035 is an alginate mixed with 400 .mu.m mannose beads.
The poragens or beads may be dissolved by local body fluids or by
irrigational or other fluids delivered to the reduced-pressure
delivery apparatus 1035 at the tissue site. Following dissolution
of the poragens or beads, the spaces previously occupied by the
poragens or beads become voids that are interconnected with other
voids to form the flow channels within the reduced-pressure
delivery apparatus 1035.
[0153] The use of poragens to create flow channels in a material is
effective, but it also forms pores and flow channels that are
limited in size to approximately the particle size of the selected
poragen. Instead of poragens, a chemical reaction may be used to
create larger pores due to the formation of gaseous by-products.
For example, in one embodiment, a flowable material may be
delivered to the tissue site 1025 that contains sodium bicarbonate
and citric acid particles (non-stoichiometric amounts may be used).
As the flowable material forms a foam or solid in situ, bodily
fluids will initiate an acid-base reaction between the sodium
bicarbonate and the citric acid. The resulting carbon dioxide gas
particles that are produced create larger pore and flow channels
throughout the reduced-pressure delivery apparatus 1035 than
techniques relying on poragen dissolution.
[0154] The transformation of the reduced-pressure delivery
apparatus 1035 from a liquid or viscous gel into a solid or a foam
can be triggered by pH, temperature, light, or a reaction with
bodily fluids, chemicals, or other substances delivered to the
tissue site. The transformation may also occur by mixing multiple
reactive components. In one embodiment, the reduced-pressure
delivery apparatus 1035 is prepared by selecting bioresorbable
microspheres made from any bioresorbable polymer. The microspheres
are dispersed in a solution containing a photoinitiator and a
hydrogel-forming material, such as hyaluronic acid, collagen, or
polyethylene glycol with photoreactive groups. The microsphere-gel
mixture is exposed to light for a brief period of time to partially
crosslink the hydrogel and immobilize the hydrogel on the
microspheres. The excess solution is drained, and the microspheres
are then dried. The microspheres are delivered to the tissue site
by injection or pouring, and following delivery, the mixture
absorbs moisture, and the hydrogel coating becomes hydrated. The
mixture is then again exposed to light, which cross-links the
microspheres, creating a plurality of flow channels. The
cross-linked microspheres then serve as a manifold to deliver
reduced pressure to the tissue site and as a porous scaffold to
promote new tissue growth.
[0155] In addition to the preceding embodiments described herein,
the reduced-pressure delivery apparatus 1035 may be made from a
variety of materials, including, without limitation, calcium
phosphate, collagen, alginate, cellulose, or any other equivalent
material that is capable of being delivered to the tissue site as a
gas, liquid, gel, paste, putty, slurry, suspension, or other
flowable material and is capable of forming multiple flow paths in
fluid communication with the tissue site. The flowable material may
further include particulate solids, such as beads, that are capable
of flowing through the manifold delivery tube 1021 if the
particulate solids are sufficiently small in size. Materials that
are delivered to the tissue site in a flowable state may polymerize
or gel in situ.
[0156] As previously described, the reduced-pressure delivery
apparatus 1035 may be injected or poured directly into the void
1029 adjacent the tissue site 1025. Referring primarily to FIG.
17A, the manifold delivery tube 1021 may include an impermeable or
semi-permeable membrane 1051 at the distal end 1043 of the manifold
delivery tube 1021. The membrane 1051 includes an inner space 1055
that fluidly communicates with a secondary lumen 1057 attached to
the manifold delivery tube 1021. The manifold delivery tube 1021 is
guided to the tissue site 1025 over a guide wire 1061.
[0157] The reduced-pressure delivery apparatus 1035 may be injected
or poured through the secondary lumen 1057 to fill the inner space
1055 of the membrane 1051. As the fluid or gel fills the membrane
1051, the membrane 1051 expands to fill the void 1029 such that the
membrane is in contact with the tissue site 1025. As the membrane
1051 expands, the membrane 1051 may be used to dissect additional
tissue adjacent or near the tissue site 1025. The membrane 1051, if
impermeable, may be physically ruptured and removed, leaving behind
the reduced-pressure delivery apparatus 1035 in contact with the
tissue site 1025. Alternatively, the membrane 1051 may be made from
a dissolvable material that dissolves in the presence of bodily
fluids or biocompatible solvents that may be delivered to the
membrane 1051. If the membrane 1051 is semi-permeable, the membrane
1051 may remain in situ. The semi-permeable membrane 1051 allows
communication of reduced pressure and possibly other fluids to the
tissue site 1025.
[0158] Referring primarily to FIG. 18, a method 1111 of
administering a reduced-pressure tissue treatment to a tissue site
includes at 1115 surgically inserting a manifold adjacent the
tissue site, the manifold having a plurality of projections
extending from a flexible barrier to create a plurality of flow
channels between the projections. The manifold is positioned at
1119 such that at least a portion of the projections are in contact
with the tissue site. At 1123, a reduced pressure is applied
through the manifold to the tissue site.
[0159] Referring primarily to FIG. 19, a method 1211 of
administering a reduced-pressure tissue treatment to a tissue site
includes at 1215 percutaneously inserting a manifold adjacent the
tissue site. The manifold may include a plurality of projections
extending from a flexible barrier to create a plurality of flow
channels between the projections. Alternatively, the manifold may
include cellular material having a plurality of flow channels
within the cellular material. Alternatively, the manifold may be
formed from an injectable or pourable material that is delivered to
the tissue site and forms a plurality of flow channels after
arriving at the tissue site. At 1219, the manifold is positioned
such that at a least a portion of the flow channels are in fluid
communication with the tissue site. A reduced pressure is applied
to the tissue site through the manifold at 1223.
[0160] Referring primarily to FIG. 20, a method 1311 of
administering a reduced-pressure tissue treatment to a tissue site
includes at 1315 percutaneously inserting a tube having a
passageway through a tissue of a patient to place a distal end of
the tube adjacent the tissue site. At 1319, a balloon associated
with the tube may be inflated to dissect tissue adjacent the tissue
site, thereby creating a void. At 1323, a manifold is delivered
through the passageway. The manifold may include a plurality of
projections extending from a flexible barrier to create a plurality
of flow channels between the projections. Alternatively, the
manifold may include cellular material having a plurality of flow
channels within the cellular material. Alternatively, the manifold
may be formed from an injectable or pourable material that is
delivered to the tissue site as described previously with reference
to FIG. 17. The manifold is positioned in the void at 1327 such
that at least a portion of the flow channels are in fluid
communication with the tissue site. At 1331, a reduced pressure is
applied to the tissue site through the manifold via a
reduced-pressure delivery tube or any other delivery means.
[0161] Referring primarily to FIG. 21, a method 1411 of
administering a reduced-pressure tissue treatment to a tissue site
includes at 1415 percutaneously inserting a tube having a
passageway through a tissue of a patient to place a distal end of
the tube adjacent the tissue site. At 1423, a manifold is delivered
through the passageway to the tissue site within an impermeable
sheath, the impermeable sheath at 1419 having been subjected to a
first reduced pressure less than an ambient pressure of the sheath.
At 1427, the sheath is ruptured to place the manifold in contact
with the tissue site. At 1431, a second reduced pressure is applied
through the manifold to the tissue site.
[0162] Referring primarily to FIGS. 22 and 23, a reduced-pressure
delivery apparatus 1511 according to an embodiment of the present
disclosure includes an orthopedic hip prosthesis 1515 for replacing
the existing femoral head of a femur 1517 of a patient. The hip
prosthesis 1515 includes a stem portion 1521 and a head portion
1525. The stem portion 1521 is elongated for insertion within a
passage 1529 reamed in a shaft of the femur 1517. A porous coating
1535 is disposed around the stem portion and preferably is
constructed from sintered or vitrified ceramics or metal.
Alternatively, a cellular material having porous characteristic
could be disposed around the stem portion. A plurality of flow
channels 1541 is disposed within the stem portion 1521 of the hip
prosthesis 1515 such that the flow channels 1541 are in fluid
communication with the porous coating 1535. A connection port 1545
is fluidly connected to the flow channels 1541, the port being
configured for releasable connection to a reduced-pressure delivery
tube 1551 and a reduced-pressure delivery source 1553. The flow
channels 1541 are used to deliver a reduced pressure to the porous
coating 1535 or the bone surrounding the hip prosthesis 1515
following implantation. The flow channels 1541 may include a main
feeder line 1543 that fluidly communicates with several lateral
branch lines 1547, which communicate with the porous coating 1535.
The lateral branch lines 1547 may be oriented normal to the main
feeder line 1543 as illustrated in FIG. 22, or may be oriented at
angles to the main feeder line 1543. An alternative method for
distributing the reduced pressure includes providing a hollow hip
prosthesis, and filling the inner space of the prosthesis with a
cellular (preferably open-cell) material that is capable of fluidly
communicating with the porous coating 1535.
[0163] Referring more specifically to FIG. 23, hip prosthesis 1515
may further include a second plurality of flow channels 1561 within
the stem portion 1521 to provide a fluid to the porous coating 1535
or the bone surrounding the hip prosthesis 1515. The fluid could
include filtered air or other gases, antibacterial agents,
antiviral agents, cell-growth promotion agents, irrigation fluids,
chemically active fluids, or any other fluid. If it is desired to
introduce multiple fluids to the bone surrounding the hip
prosthesis 1515, additional paths of fluid communication may be
provided. A connection port 1565 is fluidly connected to the flow
channels 1561, the connection port 1565 being configured for
releasable connection to a fluid delivery tube 1571 and a fluid
delivery source 1573. The flow channels 1561 may include a main
feeder line 1583 that fluidly communicates with several lateral
branch lines 1585, which communicate with the porous coating 1535.
The lateral branch lines 1585 may be oriented normal to the main
feeder line 1583 as illustrated in FIG. 23, or may be oriented at
angles to the main feeder line 1583.
[0164] The delivery of reduced pressure to the first plurality of
flow channels 1541 and the delivery of the fluid to the second
plurality of flow channels 1561 may be accomplished by separate
tubes, such as reduced-pressure delivery tube 1551 and fluid
delivery tube 1571. Alternatively, a tube having multiple lumens as
described previously herein may be used to separate the
communication paths for delivering the reduced pressure and the
fluid. It should further be noted that while it is preferred to
provide separate paths of fluid communication within the hip
prosthesis 1515, the first plurality of flow channels 1541 could be
used to deliver both the reduced pressure and the fluid to the bone
surrounding the hip prosthesis 1515.
[0165] As previously described, application of reduced pressure to
bone tissue promotes and speeds the growth of new bone tissue. By
using the hip prosthesis 1515 as a manifold to deliver reduced
pressure to the area of bone surrounding the hip prosthesis,
recovery of the femur 1517 is faster, and the hip prosthesis 1515
integrates more successfully with the bone. Providing the second
plurality of flow channels 1561 to vent the bone surrounding the
hip prosthesis 1515 improves the successful generation of new bone
around the prosthesis.
[0166] Following the application of reduced pressure through the
hip prosthesis 1515 for a selected amount of time, the
reduced-pressure delivery tube 1551 and fluid delivery tube 1571
may be disconnected from the connection ports 1545, 1565 and
removed from the patient's body, preferably without a
surgically-invasive procedure. The connection between the
connection ports 1545, 1565 and the tubes 1551, 1571 may be a
manually-releasable connection that is effectuated by applying an
axially-oriented tensile force to the tubes 1551, 1571 on the
outside of the patient's body. Alternatively, the connection ports
1545, 1565 may be bioresorbable or dissolvable in the presence of
selected fluids or chemicals such that release of the tubes 1551,
1571 may be obtained by exposing the connection ports 1545, 1565 to
the fluid or chemical. The tubes 1551, 1571 may also be made from a
bioresorbable material that dissolves over a period of time or an
activated material that dissolves in the presence of a particular
chemical or other substance.
[0167] The reduced-pressure delivery source 1553 may be provided
outside the patient's body and connected to the reduced-pressure
delivery tube 1551 to deliver reduced pressure to the hip
prosthesis 1515. Alternatively, the reduced-pressure delivery
source 1553 may be implanted within the patient's body, either
on-board or near the hip prosthesis 1515. Placement of the
reduced-pressure delivery source 1553 within the patient's body
eliminates the need for a percutaneous fluid connection. The
implanted reduced-pressure delivery source 1553 may be a
traditional pump that is operably connected to the flow channels
1541. The pump may be powered by a battery that is implanted within
the patient, or may be powered by an external battery that is
electrically and percutaneously connected to the pump. The pump may
also be driven directly by a chemical reaction that delivers a
reduced pressure and circulates fluids through the flow channels
1541, 1561.
[0168] While only the stem portion 1521 and head portion 1525 of
the hip prosthesis 1515 are illustrated in FIGS. 22 and 23, it
should be noted that the flow channels and means for applying
reduced-pressure tissue treatment described herein could be applied
to any component of the hip prosthesis 1515 that contacts bone or
other tissue, including, for example, the acetabular cup.
[0169] Referring primarily to FIG. 24, a method 1611 for repairing
a joint of a patient includes at 1615 implanting a prosthesis
within a bone adjacent the joint. The prosthesis could be a hip
prosthesis as described above or any other prosthesis that assists
in restoring mobility to the joint of the patient. The prosthesis
includes a plurality of flow channels configured to fluidly
communicate with the bone. At 1619, a reduced pressure is applied
to the bone through the plurality of flow channels to improve
oseointegration of the prosthesis.
[0170] Referring primarily to FIGS. 25 and 26, a reduced-pressure
delivery apparatus 1711 according to an embodiment of the present
disclosure includes an orthopedic fixation device 1715 for securing
a bone 1717 of a patient that includes a fracture 1719 or other
defect. The orthopedic fixation device 1715 illustrated in FIGS. 25
and 26 is a plate having a plurality of passages 1721 for anchoring
the orthopedic fixation device 1715 to the bone 1717 with screws
1725, pins, bolts, or other fasteners. A porous coating 1735 may be
disposed on a surface of the orthopedic fixation device 1715 that
is to contact the bone 1717. The porous coating is preferably
constructed from sintered or vitrified ceramics or metal.
Alternatively, a cellular material having porous characteristic
could be disposed between the bone 1717 and the orthopedic fixation
device 1715. A plurality of flow channels 1741 is disposed within
the orthopedic fixation device 1715 such that the flow channels
1741 are in fluid communication with the porous coating 1735. A
connection port 1745 is fluidly connected to the flow channels
1741, the port being configured for connection to a
reduced-pressure delivery tube 1751 and a reduced-pressure delivery
source 1753. The flow channels 1741 are used to deliver a reduced
pressure to the porous coating 1735 or the bone surrounding the
orthopedic fixation device 1715 following fixation of the
orthopedic fixation device 1715 to the bone 1717. The flow channels
1741 may include a main feeder line 1743 that fluidly communicates
with several lateral branch lines 1747, which communicate with the
porous coating 1735. The lateral branch lines 1747 may be oriented
normal to the main feeder line 1743 as illustrated in FIG. 25, or
may be oriented at angles to the main feeder line 1743. An
alternative method for distributing the reduced pressure includes
providing a hollow orthopedic fixation device, and filling the
inner space of the orthopedic fixation device with a cellular
(preferably open-cell) material that is capable of fluidly
communicating with the porous coating 1735.
[0171] The orthopedic fixation device 1715 may be a plate as shown
in FIG. 25, or alternatively may be a fixation device, such as a
sleeve, a brace, a strut, or any other device that is used to
stabilize a portion of the bone. The orthopedic fixation device
1715 may further be fasteners used to attach prosthetic or other
orthopedic devices or implanted tissues (e.g., bone tissues or
cartilage), provided that the fasteners include flow channels for
delivering reduced pressure to tissue adjacent to or surrounding
the fasteners. Examples of these fasteners may include pins, bolts,
screws, or any other suitable fastener.
[0172] Referring more specifically to FIG. 26, the orthopedic
fixation device 1715 may further include a second plurality of flow
channels 1761 within the orthopedic fixation device 1715 to provide
a fluid to the porous coating 1735 or the bone surrounding the
orthopedic fixation device 1715. The fluid could include filtered
air or other gases, antibacterial agents, antiviral agents,
cell-growth promotion agents, irrigation fluids, chemically active
agents, or any other fluid. If it is desired to introduce multiple
fluids to the bone surrounding the orthopedic fixation device 1715,
additional paths of fluid communication may be provided. A
connection port 1765 is fluidly connected to the flow channels
1761, the connection port 1765 being configured for connection to a
fluid delivery tube 1771 and a fluid delivery source 1773. The flow
channels 1761 may include a main feeder line 1783 that fluidly
communicates with several lateral branch lines 1785, which
communicate with the porous coating 1735. The lateral branch lines
1785 may be oriented normal to the main feeder line 1783 as
illustrated in FIG. 23, or may be oriented at angles to the main
feeder line 1783.
[0173] The delivery of reduced pressure to the first plurality of
flow channels 1741 and the delivery of the fluid to the second
plurality of flow channels 1761 may be accomplished by separate
tubes, such as reduced-pressure delivery tube 1751 and fluid
delivery tube 1771. Alternatively, a tube having multiple lumens as
described previously herein may be used to separate the
communication paths for delivering the reduced pressure and the
fluid. It should further be noted that while it is preferred to
provide separate paths of fluid communication within the orthopedic
fixation device 1715, the first plurality of flow channels 1741
could be used to deliver both the reduced pressure and the fluid to
the bone adjacent the orthopedic fixation device 1715.
[0174] The use of orthopedic fixation device 1715 as a manifold to
deliver reduced pressure to the area of bone adjacent the
orthopedic fixation device 1715 speeds and improves recovery of the
fracture 1719 of the bone 1717. Providing the second plurality of
flow channels 1761 to communicate fluids to the bone surrounding
the orthopedic fixation device 1715 improves the successful
generation of new bone near the orthopedic fixation device.
[0175] Referring primarily to FIG. 27, a method 1811 for healing a
bone defect of a bone includes at 1815 fixating the bone using an
orthopedic fixation device. The orthopedic fixation device includes
a plurality of flow channels disposed within the orthopedic
fixation device. At 1819, a reduced pressure is applied to the bone
defect through the plurality of flow channels.
[0176] Referring primarily to FIG. 28, a method 1911 for
administering reduced-pressure tissue treatment to a tissue site
includes at 1915 positioning a manifold having a plurality of flow
channels such that at least a portion of the flow channels are in
fluid communication with the tissue site. A reduced pressure is
applied at 1919 to the tissue site through the flow channels, and a
fluid is delivered at 1923 to the tissue site through the flow
channels.
[0177] Referring primarily to FIG. 29, a method 2011 for
administering reduced-pressure tissue treatment to a tissue site
includes at 2015 positioning a distal end of a manifold delivery
tube adjacent the tissue site. At 2019 a fluid is delivered through
the manifold delivery tube to the tissue site. The fluid is capable
of filling a void adjacent the tissue site and becoming a solid
manifold having a plurality of flow channels in fluid communication
with the tissue site. A reduced pressure is applied at 2023 to the
tissue site through the flow channels of the solid manifold.
[0178] Referring primarily to FIGS. 30-38, a reduced-pressure
delivery system 2111 includes a primary manifold 2115 having a wall
2117 surrounding a primary flow passage 2121. The wall 2117 is
connected at a proximal end 2123 to a reduced-pressure delivery
tube 2125. Since the shape of the reduced-pressure delivery tube
2125 will typically be round in cross-section, and since the shape
of the primary manifold 2115 in cross-section may be other than
round (i.e. rectangular in FIGS. 30-35 and triangular in FIGS.
36-38), a transition region 2129 is provided between the
reduced-pressure delivery tube 2125 and the primary manifold 2115.
The primary manifold 2115 may be adhesively connected to the
reduced-pressure delivery tube 2125, connected using other means,
such as fusing or insert molding, or alternatively may be
integrally connected by co-extrusion. The reduced-pressure delivery
tube 2125 delivers reduced pressure to the primary manifold 2115
for distribution at or near the tissue site.
[0179] The wall 2117 may be made from a flexible material, a rigid
material, or a combination of both flexible and rigid materials.
For example, a medical grade silicone polymer or other flexible
materials may be molded, extruded, or otherwise manufactured to
form a flexible wall 2117. Alternatively, rigid materials including
but not limit to metals, polyvinylchloride (PVC), polyurethane, and
other rigid polymeric materials may be molded, extruded, or
otherwise manufactured to form a rigid wall 2117.
[0180] A blockage prevention member 2135 is positioned within the
primary manifold to prevent collapse of the primary manifold 2115,
and thus blockage of the primary flow passage 2121 during
application of reduced pressure. In one embodiment, the blockage
prevention member 2135 may be a plurality of projections 2137 (see
FIG. 34) disposed on an inner surface 2141 of the wall 2117 and
extending into the primary flow passage 2121. In another
embodiment, the blockage prevention member 2135 may be a single or
multiple ridges 2145 disposed on the inner surface 2141 (see FIGS.
30 and 31). In yet another embodiment, the blockage prevention
member 2135 may include a cellular material 2149 disposed within
the primary flow passage, such as that illustrated in FIG. 37. The
blockage prevention member 2135 may be any material or structure
that is capable of being inserted within the flow passage or that
is capable of being integrally or otherwise attached to the wall
2117. When the wall 2117 is made from a flexible material, the
blockage prevention member 2135 is able to prevent total collapse
of the wall 2117, while still allowing the flow of fluids through
the primary flow passage 2121.
[0181] The wall 2117 further includes a plurality of apertures 2155
through the wall 2117 that communicate with the primary flow
passage 2121. The apertures 2155 allow reduced pressure delivered
to the primary flow passage 2121 to be distributed to the tissue
site. Apertures 2155 may be selectively positioned around the
circumference of the primary manifold 2115 to preferentially direct
the delivery of vacuum.
[0182] The reduced-pressure delivery tube 2125 preferably includes
a first conduit 2161 having at least one outlet fluidly connected
to the primary flow passage 2121 to deliver reduced pressure to the
primary flow passage 2121. A second conduit 2163 may also be
provided to purge the primary flow passage 2121 and the first
conduit 2161 with a fluid to prevent or resolve blockages caused by
wound exudate and other fluids drawn from the tissue site. The
second conduit 2163 preferably includes at least one outlet
positioned proximate to at least one of the primary flow passage
2121 and the at least one outlet of the first conduit 2161.
[0183] Referring more specifically to FIGS. 30 and 31, the
reduced-pressure delivery system 2111 may include multiple conduits
for purging the primary flow passage 2121 and the first conduit
2161. While the end of the wall 2117 opposite the end attached to
reduced-pressure delivery tube 2125 may be open as illustrated in
FIG. 30, it has been found that capping the end of the wall 2117
may improve the performance and reliability of the purging
function. Preferably, a head space 2171 is provided for between the
capped end of the wall and the end of the second conduit 2163. The
head space 2171 allows for a buildup of purge fluid during the
purging process, which helps drive the purge fluid through the
primary flow passage 2121 and into the first conduit 2161.
[0184] Also illustrated in FIG. 31 is the divider that serves as
the blockage prevention member 2135. The centrally-located divider
bifurcates the primary flow passage 2121 into two chambers, which
allows continued operation of the primary manifold 2115 if one of
the chambers becomes blocked and purging is unable to resolve the
blockage.
[0185] Referring primarily to FIGS. 39 and 40, a reduced-pressure
delivery system 2211 includes a primary manifold 2215 that is
integral to a reduced-pressure delivery tube 2217. The
reduced-pressure delivery tube 2217 includes a central lumen 2223
and a plurality of ancillary lumens 2225. While the ancillary
lumens 2225 may be used to measure pressure at or near the tissue
site, the ancillary lumens 2225 may further be used to purge the
central lumen 2223 to prevent or resolve blockages. A plurality of
apertures 2231 communicate with the central lumen 2223 to
distribute the reduced pressure delivered by the central lumen
2223. As illustrated in FIG. 40, it is preferred that the apertures
2231 not penetrate the ancillary lumens 2225. Also illustrated in
FIG. 40 is the countersunk end of the reduced-pressure delivery
tube, which creates a head space 2241 beyond the end of the
ancillary lumens 2225. If tissue, scaffolds, or other materials
were to engage the end of the reduced-pressure delivery tube 2217
during application of reduced pressure, the head space 2241 would
continue to allow purging fluid, which may be a liquid or gas, to
be delivered to the central lumen 2223.
[0186] In operation, the reduced-pressure delivery systems 2111,
2211 of FIGS. 30-40 may be applied directly to a tissue site for
distributing reduced pressure to the tissue site. The low-profile
shape of the primary manifolds is highly desirous for the
percutaneous installation and removal techniques described herein.
Similarly, the primary manifolds may also be inserted
surgically.
[0187] Referring now primarily to FIGS. 41 and 42, a manifold 5115
is shown according to an illustrative embodiment. FIG. 42 is a
longitudinal cross-sectional view of the manifold 5115. The
manifold 5115 is adapted to be inserted into a patient and placed
at the subcutaneous tissue site. The manifold 5115 includes a
plurality of first conduits 5121 that are adjacent to one another
to form an interior space that defines a second conduit 5163
between the first conduits 5121. The plurality of first conduits
5121 may be spaced in a uniform pattern or an irregular pattern and
the members of the first plurality of conduits 5121 may be uniform
in size or vary. The first conduits 5115 may be coupled one to
another by a plurality of bonds, e.g., welds, cement, bonds, etc.
The manifold 5115 provides a reduced-pressure supply function and
purging function using the first conduits 5121 and second conduit
5163. In one non-limiting example, the second conduit 5163 may
communicate with each of the first conduits 5121 via a plurality of
second apertures 5140.
[0188] The manifold 5115 includes first conduits 5121. Each of the
first conduits 5121 has at least one first aperture 5131 and at
least one second aperture 5140 formed in a wall 5125, e.g., an
annular wall. In the non-limiting examples of FIGS. 51 and 52, each
of the first conduits 5121 has a plurality of first apertures 5131
and a plurality of second apertures 5140 formed in the wall 5125.
The first apertures 5131 may be uniformly or non-uniformly spaced
from one another and may be uniform or non-uniform in diameter.
Also, the second apertures 5140 may be uniformly or non-uniformly
spaced from one another and may be uniform or non-uniform in
diameter.
[0189] In one illustrative embodiment, at least one of the first
conduits 5121 is in fluid communication with a reduced-pressure
source, such as the reduced-pressure source 427 in FIG. 9. At least
one of the first conduits 5121 may deliver reduced pressure from
the reduced-pressure source to a tissue site via the first
apertures 5131. The first conduits 5121 may also deliver reduced
pressure to any portion of the manifold 5115, such as a distal end
5182 of the manifold 5115. In another illustrative embodiment, each
of the first conduits 5121 is in fluid communication with a
reduced-pressure source, and each of first conduits 5121 delivers
reduced pressure to a subcutaneous tissue site via the first
apertures 5131. The flow of fluid in a direction away from the
distal end 5182 of the manifold 5115 through the first conduits
5121 is represented by the arrows 5171. The flow of fluid away from
the manifold 5115 in this manner causes a reduced pressure at the
first conduits 5121 or at least a portion of the first conduits to
be transferred to a tissue site via the first apertures 5131.
[0190] Each the first apertures 5131 allow fluid communication
between the first conduits 5121 and a space outside of the manifold
5115, such as a tissue site. In addition to permitting the transfer
of reduced pressure from the first conduits 5121 to a tissue site,
the first apertures 5131 may also allow exudate or other fluid from
the tissue site to enter the first conduits 5121. The flow of fluid
from the space outside of the manifold 5115 into the first conduits
5121 is represented by arrows 5172.
[0191] The first conduits 5121 are shown with a circular
cross-sectional shape. However, the first conduits 5121 may have
any cross-sectional shape, including an elliptical, diamond,
triangular, square, polygonal, etc.
[0192] In addition, although FIG. 41 shows the manifold 5115 having
four first conduits 5121, the manifold 5115 may have any number of
first conduits. For example, the manifold 5115 may have two or more
first conduits 5121 that at least partially encompass and form the
second conduit 5163. The second conduit 5163 may be centrally
disposed between the two or more first conduits 5121 and typically
between at least three of the first conduits 5121.
[0193] Each of the first apertures 5131 is shown to have a circular
cross-sectional shape. However, each of the first apertures 5131
may have any cross-sectional shape, such as an elliptical or
polygonal cross-sectional shape. In another example, each of the
first apertures 5131 may be slits that extend along all or a
portion of the first conduits 5121. As used herein, a "slit" is any
elongated hole, aperture, or channel. In one illustrative
embodiment, each of the slits may be substantially parallel to one
another.
[0194] The second conduit 5163 of the manifold 5115 is formed by a
portion of each of the outer surfaces 5184 and 5186 of the first
conduits 5121. Each of the second apertures 5140 is located on the
portion of each of the outer surfaces 5184 and 5186 of the first
conduits 5121 that form the second conduit 5163. The second conduit
5163 is typically centrally formed, or otherwise disposed, between
the first conduits 5121. The second conduit 5163 is in fluid
communication with the first conduits 5121 via the second apertures
5140.
[0195] The second conduit 5163 may be in fluid communication with a
fluid source (not shown) that supplies a fluid to the tissue site
or portions of the first conduit 5121. The second conduit 5163 may
receive fluid from the fluid source. In one embodiment, the second
conduit 5163 delivers the fluid to each of the first conduits 5121
via the second apertures 5140. The second conduit 5163 may also
deliver a fluid to a distal portion of the manifold 5115, including
the end of the manifold 5115. The second conduit 5163 may also
deliver a fluid to the tissue space around the manifold 5115. The
fluid delivered by the second conduit 5163 may be a gas, such as
air, or a liquid. The flow of fluid delivered by the second conduit
5163 is represented by arrows 5173. In an alternative embodiment,
fluid from a fluid source may be delivered toward the distal end
5182 of the manifold 5115 by any one or more of the first conduits
5121.
[0196] In one non-limiting embodiment, the first conduits 5121 draw
fluid from the second conduit 5163 via the second apertures 5140.
In this embodiment, reduced pressure from a reduced-pressure source
causes the fluid to be drawn from the second conduit 5163 to the
first conduits 5121 via the second apertures 5140. In another
non-limiting embodiment, positive pressure provided by the fluid
source and delivered by the second conduit 5163 forces, or
otherwise causes, the fluid to be transferred from the second
conduit 5163 to the first conduits 5121 via the second apertures
5140. The transfer of fluid from the second conduit 5163 to the
first conduits 5121 via the second apertures 5140 facilitates the
purging function of the manifold 5115 that helps to remove or
reduce any blockages that form in the manifold 5115. The first
conduits 5121 may include any number of second apertures 5140,
which number may control the rate of fluid being transferred from
the second conduit 5163 to the first conduits 5121.
[0197] In one embodiment, the manifold 5115 may also include an end
cap 5170 that is adapted to be coupled or is coupled to the distal
end 5182 of the manifold 5115 to form a distribution space. Fluid
delivered by the second conduit 5163 may be transferred from the
second conduit 5163 to the first conduits 5121 via the space that
is formed by coupling the end cap 5170 to the distal end 5182 of
the manifold 5115. In one embodiment, the space may provide the
sole passageway through which fluid is transferred from the second
conduit 5163 to the first conduits 5121. In this embodiment, no
second apertures 5140 may be present on the first conduits 5121 or
a minimal number of apertures 5140.
[0198] In one illustrative embodiment, the second apertures 5140
are absent or not open to the outside of the manifold 5115 and
fluid, such as liquid or air, may be drawn into the second conduit
5163 by opening a valve to atmosphere (e.g., air purge). The valve
is in fluid communication with the second conduit 5163. Thus, fluid
may be drawn through the second conduit 5163 and back toward a
reduced-pressure device via the first conduits 5121, which, while
under reduced pressure, may supply the force to draw any clot/clog
formations, such as fibrin formations, out of the manifold 5115 and
toward the reduced-pressure source. In this embodiment, no supply
port for the second conduit 5163 may be present on the outer
surface of the manifold 5115. In this illustrative embodiment, the
second conduit 5163 may be completely enclosed by the first
conduits 5121, including a distal end of the second conduit 5163,
and thus may be closed from an outside environment, such as a
tissue space. The second conduit 5163 communicates proximate end
cap 5170 from the second conduit 5163 to the first conduits 5121.
This illustrative embodiment may allow for a fluid to be contained
within the manifold 5115 as the fluid moves from the second conduit
5163 to the first conduits 5121. Thus, in this embodiment, the
likelihood of the fluid moving out into the tissue space is reduced
or eliminated.
[0199] In one illustrative, non-limiting embodiment, the manifold
5115 is formed with four of the first conduits 5121. As before, the
first conduits 5121 form the second conduit 5163. Each of the four
first conduits 5121 touch at least two other of the four first
conduits 5121. In this embodiment, the four first conduits 5121 and
second conduit 5163 are formed by co-extruding the conduits 5121,
5163. After the extruding the conduits 5121, 5163, a core pin may
be used to pierce the conduits straight through to form the first
apertures 5131. Thus, for example, a core pin may pierce the upper
right (for the orientation in FIG. 41) first conduit 5121 and the
lower left first conduit 5121--and concomitantly pierce the second
conduit 5163. This may be repeated as many times as desired and at
various orientations.
[0200] In the example in which the fluid in second conduit 5163 is
a liquid, the liquid may be pumped in or gravity fed down the
second conduit 5163 such that the only pathway for the liquid is
through the second apertures 5140 and into the first conduits 5121,
along the first conduits 5121, and toward the reduced-pressure
source. The manifold 5115 preferably has a symmetrical design, and
the symmetrical design of the manifold 5115 allows the manifold
5115 to be used in any spatial orientation to achieve the same or
similar results in each position.
[0201] In another illustrative embodiment, a supplied fluid may be
allowed to enter the space surrounding the manifold 5115, such as a
tissue space. For example, the fluid may exit the manifold 5115 at
the opening at the distal end 5182 of the second conduit 5163. The
fluid may then be drawn into the first conduits 5121.
[0202] In one illustrative embodiment, a method for applying
reduced pressure to a subcutaneous tissue site includes applying
the manifold 5115 to the subcutaneous tissue site. The manifold
5115 may be percutaneously inserted into a patient, and the
manifold 5115 may be positioned adjacent to or abutting the
subcutaneous tissue site. The symmetrical design of the manifold
5115 may facilitate the implantation of the manifold in any
orientation.
[0203] In one illustrative embodiment, a method of manufacturing an
apparatus for applying reduced pressure to a subcutaneous tissue
site includes providing first conduits 5121. The method may also
include coupling the first conduits 5121 to one another to form the
second conduit 5163. The second conduit 5163 is formed by a portion
of each outer surface 5184 and 5186 of the first conduits 5121. The
method may also include providing a delivery conduit for delivering
reduced pressure to at least one of the first conduits 5121. The
method may also include fluidly coupling the delivery conduit to
the first conduits 5121 and the second conduit 5163.
[0204] Referring now primarily to FIG. 43, another illustrative,
non-limiting embodiment of the manifold 5115 is presented. The
manifold 5115 includes the plurality of first conduits 5121 that
are coupled in a spaced relationship with a plurality of bonds
5117. Each of the plurality of first conduits 5121 may have
differing diameters or the same diameters, and in this illustrative
embodiment, one conduit 5123 of the first conduits conduit 5121 is
shown with a smaller diameter than the others. It should be
understood in this and the other illustrative embodiments that the
diameter of the first conduits may be varied or may be uniform.
[0205] The manifold 5115 includes the second conduit 5163 formed by
a portion of each of the outer surfaces 5184 of the first conduits
5121. The second conduit 5163 is shown with broken lines and in
this illustration is a star-like shape. One or more additional
conduits, such as third conduit 5165, may be disposed within the
second conduit 5163. The additional conduit 5165 may be sized to
touch each of the plurality of first conduits 5121 as shown or may
be smaller in size. The additional conduit, or third conduit 5165,
may be coupled to one or more of the first conduits 5121. In an
alternative embodiment (not shown), the first conduits 5121 may not
form or fully form the second conduit, but the manifold 5115 may
have the additional conduit 5165 at a center position adjacent to
each of the first conduits 5121.
[0206] The additional conduit 5165 may carry a purging fluid or may
be used to carry other fluids to or from a distal end (not shown)
of the manifold 5115. The space 5167 formed exterior to the
additional conduit 5165 and on the interior of the second conduit
5163 may carry a purging fluid to be introduced through apertures
in the outer wall portion 5184 of the first conduits 5121, and the
additional conduit 5165 may carry a purging fluid to an end cap
(e.g., end cap 5170 in FIG. 42) to introduce a purging fluid into
the first conduits 5121 at the distal end. The end cap 5170 may be
attached to the distal end 5182 using interference fit, RF welding,
RF formed tip process, solvent bonding, or any other coupling
technique.
[0207] Referring primarily to FIGS. 44A and 44B, a manifold 5315 is
shown according to an illustrative embodiment. The manifold 5315
includes purging lumen 5363 and reduced-pressure lumens 5321 that
are at least partially separated by lumen walls 5380. In one
non-limiting example, the purging lumen 5363 may communicate with
each of the reduced-pressure lumens 5321 via the interlumen
channels 5340 and head space 5371.
[0208] The manifold 5315 includes reduced-pressure lumens 5321 to
transfer reduced pressure from a reduced-pressure source. The
reduced-pressure lumens 5321 deliver reduced pressure from a
reduced-pressure source to a tissue site, or any portion of the
manifold 5315. The flow of fluid in a direction away from the end
5382 of the manifold 5315 through the reduced-pressure lumens 5321
is represented by the arrows 5369. The flow of fluid away from the
manifold 5315 in this manner causes a reduced pressure at the
reduced-pressure lumens 5321 that may be transferred to a tissue
site, as well as other portions of the manifold 5315. The
reduced-pressure lumens 5321 may have any cross-sectional shape,
including a circular, elliptical, flattened, irregular, or
polygonal cross-sectional shape. In one example, the material from
which the manifold 5315 is made may be flexible, causing the
cross-sectional shape of the reduced-pressure lumens 5321 to vary
depending on fluid flow through the lumens. In addition, although
FIGS. 44A and 44B show the manifold 5315 to have two
reduced-pressure lumens 5321, the manifold 5315 may have any number
of reduced-pressure lumens depending on the particular
implementation.
[0209] The reduced-pressure lumens 5321 also include apertures
5331. Reduced pressure from a reduced-pressure source may be
delivered to a tissue site via the apertures 5331 of the
reduced-pressure lumens 5321. Each of the apertures 5331 allows
fluid communication between the reduced-pressure lumens 5321 and a
space outside of the manifold 5315, such as a tissue site. In
addition to permitting the transfer of reduced pressure from the
reduced-pressure lumens 5321 to a tissue site, the apertures 5331
may also allow exudate or other fluid from the tissue site to enter
the reduced-pressure lumens 5321. The flow of fluid from the space
outside of the manifold 5315 into the reduced-pressure lumens 5321
is represented by arrows 5372.
[0210] Each of the apertures 5331 may have a circular
cross-sectional shape. However, each of the apertures 5331 may have
any cross-sectional shape, such as an elliptical, polygonal,
irregular cross-sectional shape. In another example, each of the
apertures 5331 may be slits that extend along all or a portion of
the reduced-pressure lumens 5321. In this example, each of the
slits may be substantially parallel to one another.
[0211] The manifold 5315 also includes purging lumen 5363. The
purging lumen 5363 is centrally disposed between the
reduced-pressure lumens 5321. The purging lumen 5363, which is
another non-limiting embodiment of the second conduit 2163 in FIGS.
30 and 31, is operable to deliver a fluid to a distal portion of
the manifold 5315, including the end 5382 of the manifold 5315. The
purging lumen 5363 may also deliver a fluid to the tissue space
around the manifold 5315. The fluid delivered by the purging lumen
5363 may be a gas, such as air, or a liquid. The flow of fluid
delivered by the purging lumen 5363 is represented by arrows
5373.
[0212] The purging lumen 5363 may have any cross-sectional shape,
including an circular, elliptical, flattened, irregular, or
polygonal cross-sectional shape. In one example, the material from
which the manifold 5315 is made may be flexible, causing the
cross-sectional shape of the purging lumen 5363 to vary depending
on fluid flow through the lumen, as well as other factors. Although
one purging lumen 5363 is shown, the manifold 5315 may include any
number of purging lumens.
[0213] The purging lumen 5363 is separated from the
reduced-pressure lumens 5321 by lumens walls 5380, which may be
flexible or rigid. The lumens walls 5380 include interlumen
channels 5340. The interlumen channels 5340 fluidly connect, or
otherwise provide fluid communication between, the purging lumen
5363 and the reduced-pressure lumens 5321. In one example, the
reduced-pressure lumens 5321 draw purging fluid from the purging
lumen 5363 via the interlumen channels 5340. In another example,
positive pressure in the purging lumen 5363 forces the fluid from
the purging lumen 5363 to the reduced-pressure lumens 5321 via the
interlumen channels 5340. The positive pressure in the purging
lumen 5363 may be supplied by a positive pressure source. The lumen
walls 5380 may include any number of interlumen channels 5340,
which number may control the rate of fluid being transferred from
the purging lumen 5363 to the reduced-pressure lumens 5321.
[0214] In another example, the transfer of fluid from the purging
lumen 5363 to the reduced-pressure lumen 5321 may occur via the
head space 5371 that is formed by coupling an end of the manifold
5315 to the end cap 5370. In one embodiment, the head space may
provide the sole passageway through which fluid is transferred from
the purging lumen 5363 to the reduced-pressure lumens 5321. In this
embodiment, no interlumen channels 5340 may be present in the
manifold 5315. To facilitate the transfer of fluid from the purging
lumen 5363 to the reduced-pressure lumens 5321, the lumens walls
5380 may terminate without touching the end cap 5370 to form the
head space 5371.
[0215] Referring primarily to FIGS. 45 and 46, a manifold 5415 is
shown according to an illustrative embodiment. FIG. 46 is a
cross-sectional view of manifold 5415 taken along line 46-46 in
FIG. 45. The manifold 5415 includes sheets 5580 and 5581. A
perimeter 5590 of the sheet 5580 is attached to a perimeter 5592 of
the sheet 5581 to form a pouch. The manifold 5415 also includes a
reduced-pressure cavity 5421 that is at least partially enclosed by
the pouch. The purging tube 5463 extends into the pouch.
[0216] The sheets 5580 and 5581 may be made from any material, and
may be rigid or flexible. In one example, the sheets 5580 and 5581
are composed of silicone. The low-profile, and potentially
flexible, nature of the manifold 5415 facilitates the movement and
placement of the manifold 5415 at a subcutaneous tissue site. The
low profile of the manifold 5415 may also ease percutaneous removal
of the manifold 5415. The pouch that is formed from the coupling
between the sheets 5580 and 5581 is shown in FIG. 45 to have a "U"
shape. The cross-sectional view of FIG. 46 shows the sheets 5580
and 5581 to have an oval or "eye" shape. However, the pouch may
also have any shape depending on the implementation, such as a
circular, polygonal, or irregular shape. In one example, the
material from which the pouch is made may be flexible, causing the
cross-sectional shape of the pouch, and therefore the
reduced-pressure cavity 5421, to vary depending on fluid flow
through the cavity, as well as other factors.
[0217] In one example, a perimeter 5590 of the sheet 5580 is
fixedly attached to a perimeter 5592 of the sheet 5581 to form
seams 5479. Alternatively, no seams may be present as a result of
the coupling between the sheets 5580 and 5581. In another example,
the sheets 5580 and 5581 are not separate sheets, but are formed
from a single continuous piece of material.
[0218] The reduced-pressure cavity 5421 transfers reduced pressure
from a reduced-pressure source. The reduced-pressure cavity 5421
may deliver reduced pressure from a reduced-pressure source to a
tissue site, or any portion of the manifold 5415. The flow of fluid
away from the end 5482 of manifold 5415 through the
reduced-pressure cavity 5421 is represented by the arrows 5469. The
flow of fluid away from the manifold 5415 in this manner causes a
reduced pressure at the reduced-pressure cavity 5421 that may be
transferred to a tissue site, as well as other portions of the
manifold 5415.
[0219] The sheets 5580 and 5581 include apertures 5531. Reduced
pressure from a reduced-pressure source may be delivered to a
tissue site via the apertures 5531. Each the apertures 5531 allow
fluid communication between the reduced-pressure cavity 5421 and a
space outside of the manifold 5415, such as a tissue site. In
addition to permitting the transfer of reduced pressure from the
reduced-pressure cavity 5421 to a tissue site, the apertures 5531
may also allow exudate or other fluid from the tissue site to enter
the reduced-pressure cavity 5421. The flow of fluid from the space
outside of the manifold 5415 into the reduced-pressure cavity 5421
is represented by arrows 5572.
[0220] Each of the apertures 5531 may have a circular
cross-sectional shape. However, each of the apertures 5531 may have
any cross-sectional shape, such as an elliptical, polygonal,
irregular cross-sectional shape. In another example, each of the
apertures 5531 may be slits that extend along all or a portion of
the sheets 5580 and 5581. In this example, each of the slits may be
substantially parallel to one another. Although the apertures 5531
are shown to be included on both the sheets 5580 and 5581, the
apertures 5531 may also be included on only one of the sheets 5580
and 5581.
[0221] The purging tube 5463 is disposed within the pouch formed by
the sheets 5580 and 5581. The purging tube 5463, which is another
non-limiting embodiment of the second conduit 2163 in FIGS. 30 and
31, is operable to deliver a fluid to a distal portion of the
manifold 5415, including the end 5482 of the manifold 5415. The
purging tube 5463 may also deliver a fluid to the tissue space
around the manifold 5415. The fluid delivered by the purging lumen
5463 may be a gas, such as air, or a liquid. The flow of fluid
delivered by the purging lumen 5463 is represented by arrows
5473.
[0222] The purging tube 5463 may have any cross-sectional shape,
including a circular, elliptical, flattened, irregular, or
polygonal cross-sectional shape. In one example, the material from
which the purging tube 5463 is made may be flexible, causing the
cross-sectional shape of the purging tube 5463 to vary depending on
fluid flow through the tube, as well as other factors. Although one
purging tube 5463 is shown, the manifold 5415 may include any
number of purging lumens.
[0223] The purging tube 5463 includes interlumen channels 5440. The
interlumen channels 5440 fluidly connect, or otherwise provide
fluid communication between, the purging tube 5463 and the
reduced-pressure cavity 5421. In one example, the reduced-pressure
cavity 5421 draws purging fluid from the purging tube 5463 via the
interlumen channels 5440. In another example, positive pressure in
the purging tube 5463 forces the fluid from the purging tube 5463
to the reduced-pressure cavity 5421 via the interlumen channels
5440. The positive pressure in the purging tube 5463 may be
supplied by a positive pressure source. The purging tube 5463 may
include any number of interlumen channels 5440, which number may
control the rate of fluid being transferred from the purging tube
5463 to the reduced-pressure cavity 5421.
[0224] In another example, the transfer of fluid from the purging
tube 5463 to the reduced-pressure cavity 5421 may occur via the
head space 5471. In this example, no end cap, such as the end cap
5470, may be placed on an end of the purging tube 5463 so that the
fluid from the purging tube 5463 may enter the head space 5471. In
one embodiment, the head space may provide the sole passageway
through which fluid is transferred from the purging tube 5463 to
the reduced-pressure cavity 5421. In this embodiment, no interlumen
channels 5440 may be present in the manifold 5415 and no end cap
may be placed on an end of the purging tube 5463. In another
example, the end cap 5470 may be placed on an end of the purging
tube 5463 so that the interlumen channels 5440 provide the sole
passageways through which fluid is transferred from the purging
tube 5463 to the reduced-pressure cavity 5421.
[0225] Referring primarily to FIG. 47, a primary manifolds 5486,
which may any manifold disclosed herein, may be used in conjunction
with a secondary manifold 5488. In FIG. 47, the secondary manifold
5488 includes a two-layered felted mat. The first layer of the
secondary manifold 5488 is placed in contact with a bone tissue
site 5489 that includes a bone fracture 5490 or other defect. The
primary manifold 5486 is placed in contact with the first layer,
and the second layer of the secondary manifold 5488 is placed on
top of the primary manifold 5486 and first layer. The secondary
manifold 5488 facilitates fluid communication between the primary
manifold 5486 and the bone tissue site 5489, yet prevents direct
contact between the bone tissue site 5489 and the primary manifold
5486.
[0226] Preferably, the secondary manifold 5488 is bioabsorbable,
which allows the secondary manifold 5488 to remain in situ
following completion of reduced-pressure treatment. Upon completion
of reduced-pressure treatment, the primary manifold 5486 may be
removed from between the layers of the secondary manifold 5488 with
little or no disturbance to the bone tissue site 5489. In one
embodiment, the primary manifold 5486 may be coated with a
lubricious material or a hydrogel-forming material to ease removal
from between the layers.
[0227] The secondary manifold 5488 preferably serves as a scaffold
for new tissue growth. As a scaffold, the secondary manifold 5488
may be comprised of at least one material selected from the group
of polylactic acid, polyglycolic acid, polycaprolactone,
polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone,
polyorthoesthers, polyphosphazenes, polyurethanes, collagen,
hyaluronic acid, chitosan, hydroxyapatite, calcium phosphate,
calcium sulfate, calcium carbonate, bioglass, stainless steel,
titanium, tantalum, allografts, and autografts.
[0228] The purging function of the reduced-pressure delivery
systems in FIGS. 30-32, 36, 39, and 40 may be employed with any of
the manifolds described herein. The ability to purge a manifold or
a conduit delivering reduced pressure prevents blockages from
forming that hinder the administration of reduced pressure. These
blockages typically form as the pressure near the tissue site
reaches equilibrium and egress of fluids around the tissue site
slows. It has been found that purging the manifold and
reduced-pressure conduit with air for a selected amount of time at
a selected interval assists in preventing or resolving blockages.
For example, purging the manifold may prevent blockages caused by
fibrin.
[0229] More specifically, air is delivered through a second conduit
separate from a first conduit that delivers reduced pressure. An
outlet of the second conduit is preferably proximate to the
manifold or an outlet of the first conduit. While the air may be
pressurized and "pushed" to the outlet of the second conduit, the
air is preferably drawn through the second conduit by the reduced
pressure at the tissue site. It has been found that delivery of air
for two (2) seconds at intervals of sixty (60) seconds during the
application of reduced pressure is sufficient to prevent blockages
from forming in many instances. This purging schedule provides
enough air to sufficiently move fluids within the manifold and
first conduit, while preventing the introduction of too much air.
Introducing too much air, or introducing air at too high of an
interval frequency will result in the reduced-pressure system not
being able to return to the target reduced pressure between purge
cycles. The selected amount of time for delivering a purging fluid
and the selected interval at which the purging fluid is delivered
will typically vary based on the design and size of system
components (e.g., the pump, tubing, etc.). However, purging fluid,
such as air, should be delivered in a quantity and at a frequency
that is high enough to sufficiently clear blockages while allowing
the full target pressure to recover between purging cycles.
[0230] Referring primarily to FIG. 48, in one illustrative
embodiment, a reduced-pressure delivery system 5491 includes a
manifold 5492 fluidly connected to a first conduit 5493 and a
second conduit 5494. The first conduit 5493 is connected to a
reduced-pressure source 5495 to provide reduced pressure to the
manifold 5492. The second conduit 5494 includes an outlet 5496
positioned in fluid communication with the manifold 5492 and
proximate an outlet of the first conduit 5493. The second conduit
5494 is fluidly connected to a valve 5497, which is capable of
allowing communication between the second conduit 5494 and the
ambient air when the valve 5497 is placed in an open position. The
valve 5497 is operably connected to a controller 5498 that is
capable of controlling the opening and closing of the valve 5497 to
regulate purging of the second conduit with ambient air to prevent
blockages within the manifold 5492 and the first conduit 5493.
[0231] It should be noted that any fluid, including liquids or
gases, could be used to accomplish the purging techniques described
herein. While the driving force for the purging fluid is preferably
the draw of reduced pressure at the tissue site, the fluid
similarly could be delivered by a fluid delivery means similar to
that discussed with reference to FIG. 9.
[0232] Referring primarily to FIGS. 49-52, a reduced-pressure
delivery apparatus 5800 is shown according to an illustrative
embodiment. The reduced-pressure treatment apparatus 5800 includes
a manifold 5815, a transition region 5829, and a delivery tube
5825. The reduced-pressure treatment apparatus 5800 delivers
reduced pressure from a reduced-pressure source, such as
reduced-pressure source 5495 in FIG. 48, to a subcutaneous tissue
site through slits 5831. The reduced-pressure treatment apparatus
5800 also includes a purging function that helps to prevent
blockages from forming in the manifold 5815.
[0233] Although not shown in FIGS. 49-52, the manifold 5815 may
include at least one purging lumen operable to deliver a fluid,
such as a gas or liquid, to a distal portion of the manifold 5815.
The manifold 5815 may also include at least one reduced-pressure
lumen operable to deliver reduced pressure to a subcutaneous tissue
site via the slits 5831. The at least one reduced-pressure lumen
may terminate at the slits 5831, which provide an opening though
which reduced pressure may be applied to a subcutaneous tissue
site. In addition, the manifold 5815 may include one or more
interlumen channels that fluidly interconnect any combination of
the at least one reduced-pressure lumen, the at least one purging
lumen, and the slits 5831. In one embodiment, the slits 5831 are
parallel to the at least one reduced-pressure lumen (not shown) and
the at least one purging lumen (not shown). The at least one
purging lumen, reduced-pressure lumen, and interlumen channel are
shown in further detail in FIGS. 53-55.
[0234] The manifold 5815 is adapted to be inserted for placement at
a subcutaneous tissue site. In the embodiment of FIGS. 49-52, the
manifold 5815 has a flattened shape to facilitate the positioning
of the manifold 5815 at a subcutaneous tissue site. In particular,
the manifold 5815 has flat side 5885 and opposing flat side 5886,
as well as curved side 5887 and opposing curved side 5888. In other
examples, each of flat sides 5885 and 5886 and curved sides 5887
and 5888 may be flat, curved, or other shape. The width 5890 of the
manifold 5815 is greater than the height 5891 of the manifold 5815,
which provides the manifold 5815 with flattened shape. However, the
width 5890 may also be equal to or less than the height 5891.
[0235] The manifold 5815 may be composed of any material capable of
being placed at a subcutaneous tissue site. In one example, the
manifold 5815 resists collapse when reduced pressure is applied
through the manifold 5815. Such resistance may be provided, at
least in part, by the structure of the manifold 5815, as well as
the material from which the manifold 5815 is made. For example, the
hardness of the material from which the manifold 5815 is made may
be adjusted such that the manifold 5815 resists collapse when
reduced pressure is applied through the manifold 5815. In one
embodiment, the manifold 5815 may be composed of silicone, such as
medical grade silicone. In another embodiment, the manifold 5815
may be composed of thermoplastic silicone polyetherurethane.
[0236] To facilitate the placement of the manifold 5815 at a
subcutaneous tissue site, the manifold 5815 may be coated with a
lubricant, which may be biocompatible or synthetic. The lubricant
may facilitate percutaneous insertion of the manifold 5815, as well
as subcutaneous movement of the manifold 5815. In one example, the
manifold 5815 is coated with either or both of heparin or
parylene.
[0237] The flat side 5885 of the manifold 5815 includes slits 5831.
The slits 5831 are located on a distal portion of the manifold
5815. Although the manifold 5815 is shown to have three slits 5831,
the manifold 5815 may have any number of slits, such as one slit.
The slits 5831 extend to the distal end of the manifold 5815. In
one example, the slits 5831 may extend across a majority of the
length 5894 of the manifold 5815. In another example, the slits
5831 may extend across the entire length 5894 of the manifold
5815.
[0238] Each of the slits 5831 are located on a single side, in
particular the flat side 5885, of the manifold 5815. However, the
slits 5831 may be located on more than side of the manifold 5815.
For example, all of the sides of the manifold 5815 may include one
or more slits. The slits 5831 may be parallel to one another, and
each has the same length. However, the slits 5831 may have any
orientation relative to one another. For example, a portion of the
slits 5831 may be perpendicular to another portion of the slits
5831. Also, the slits 5831 may have non-uniform lengths, including
an example in which each of the slits 5831 have different
lengths.
[0239] The manifold 5815 may also include an end cap 5870 that is
attachable to an end of the manifold 5815 to form a head space,
such as head space 2171 in FIG. 31. The end cap 5870 may be
permanently or removably attached to the manifold 5815. The head
space may accumulate fluid from the at least one purging lumen
prior to the fluid being drawn via the at least one
reduced-pressure lumen.
[0240] The reduced-pressure treatment apparatus 5800 also includes
the reduced-pressure delivery tube 5825. The delivery tube 5825 is
in fluid communication with the manifold 5815. In one embodiment,
the delivery tube 5825 delivers reduced pressure to the at least
one reduced-pressure lumen and fluid, such as gas or liquid, to the
at least one purge lumen. The delivery tube 5825 may have any
cross-sectional shape, such as a circular, elliptical, polygonal,
or irregular cross-sectional shape.
[0241] The reduced-pressure treatment apparatus 5800 also includes
the transition region 5829 disposed between the delivery tube 5825
and the manifold 5815. In one example, the transition region 5829
facilitates fluid communication between the delivery tube 5825 and
the manifold 5815. One end 5895 may be sized to fit the delivery
tube 5825, while the other end 5896 may be adapted to fit the
manifold 5815.
[0242] Referring primarily to FIGS. 53 and 54, cross-sectional
views of the manifold 5815 are shown according to an illustrative
embodiment. In particular, FIG. 53 is a cross-sectional view of the
manifold 5815 taken along line 53-53 in FIG. 49. FIG. 54 is a
cross-sectional view of the manifold 5815 taken along line 54-54 in
FIG. 49.
[0243] The manifold 5815 includes reduced-pressure lumens 6321 to
transfer reduced pressure from a reduced-pressure source, such as
reduced-pressure source 5495 in FIG. 48. The reduced-pressure
lumens 6321 deliver reduced pressure from a reduced-pressure source
to a tissue site, or any portion of the manifold 5815. The
reduced-pressure lumens 6321 may have any cross-sectional shape,
including a circular, elliptical, flattened, irregular, or
polygonal cross-sectional shape. In one example, the material from
which the manifold 5815 is made may be flexible, causing the
cross-sectional shape of the reduced-pressure lumens 6321 to vary
depending on fluid flow through the lumens, as well as other
factors. In addition, although FIG. 54 shows the manifold 5815 to
have three reduced-pressure lumens 6321, the manifold 5815 may have
any number of reduced-pressure lumens depending on the particular
implementation.
[0244] As the reduced-pressure lumens 6321 extend toward the distal
end of the manifold 5815, the reduced-pressure lumens 6321 may
gradually open toward flat side 5885 to become the slits 5831. In
this manner, each of the reduced-pressure lumens 6321 may terminate
at a respective slit 5831. Thus, at least one wall of each of the
reduced-pressure lumens 6321 may be contiguous with a wall of a
respective slit. The number of reduced-pressure lumens 6321 is
equal to the number of slits 5831 in the manifold 5815.
[0245] Reduced pressure from a reduced-pressure source may be
delivered to a tissue site via the slits 5831. Each the slits 5831
allow fluid communication between the reduced-pressure lumens 6321
and a space outside of the manifold 5815, such as a subcutaneous
tissue site. In addition to permitting the transfer of reduced
pressure from the reduced-pressure lumens 6321 to a tissue site,
the slits 6331 may also allow exudate or other fluid from the
tissue site to enter the reduced-pressure lumens 6321. The
orientation of the slits 6331 relative to the reduced-pressure
lumens 6321, including, in some cases, a perpendicular orientation,
may also help prevent soft tissue from entering the
reduced-pressure lumens 6321, thereby preventing blockages and soft
tissue damage.
[0246] The manifold 5815 also includes purging lumens 6263.
Although the manifold 5815 is shown to have four purging lumens
6263, the manifold 5815 may have any number of purging lumens. The
purging lumens 6263, which are another non-limiting embodiment of
the second conduit 2163 in FIGS. 30 and 31, are operable to deliver
a fluid to a distal portion of the manifold 5815, including the end
of the manifold 5815. The purging lumens 6263 may also deliver a
fluid to the tissue space around the manifold 5815. The fluid
delivered by the purging lumens 6263 may be a gas, such as air, or
a liquid. In one embodiment, one or more of the purging lumens 6263
may be a sensing lumen. The reduced pressure at a subcutaneous
tissue site may be detectable using the one or more sensing
lumens.
[0247] The purging lumens 6263 may have any cross-sectional shape,
including an circular, elliptical, flattened, irregular, or
polygonal cross-sectional shape. In one example, the material from
which the manifold 5815 is made may be flexible, causing the
cross-sectional shape of the purging lumens 6263 to vary depending
on fluid flow through the lumens.
[0248] The manifold 5815 includes interlumen channel 6240. The
interlumen channel 6240 fluidly connects, or otherwise provides
fluid communication between the purging lumens 6263 and either or
both of the reduced-pressure lumens 6321 and the slits 5831. In one
example, the reduced-pressure lumens 6321 draw purging fluid from
the purging lumens 6263 via the interlumen channel 6240. In another
example, positive pressure in the purging lumens 6263 forces the
fluid from the purging lumens 6263 to the reduced-pressure lumens
6321 via the interlumen channel 6240. The positive pressure in the
purging lumens 6263 may be supplied by a positive pressure
source.
[0249] The manifold 5815 may include any number of interlumen
channels, such as interlumen channel 6240. For example, the
manifold 5815 may include two or more interlumen channels that are
located at any point along the length 5894 of the manifold 5815. In
one non-limiting example, the interlumen channels 6240 may be
uniformly or non-uniformly spaced apart from one another. In
another non-limiting example, the interlumen channels 6240, or a
number of the interlumen channels 6240, may be closer to one
another at designated portions of the manifold 5815, such as the
portion of the manifold 5815 that includes slits 5831. In another
non-limiting example, all of the interlumen channels 6240 may be
located at the portion of the manifold 5815 that includes slits
5831. The number of interlumen channels may control the rate of
fluid being transferred, or the cross-flow, from the purging lumens
6263 to the reduced-pressure lumens 6321. The inclusion of two or
more interlumen channels 6240 may allow continued fluid
communication between the purging lumens 6263 and the
reduced-pressure lumens 6321 in the event that one or more of the
interlumen channels becomes blocked or occluded by fibrin or other
materials.
[0250] In another example, the transfer of fluid from the purging
lumens 6263 to the reduced-pressure lumens 6321 may occur via the
head space that is formed by coupling an end of the manifold 5815
to the end cap 5870 in FIGS. 49-52. In one embodiment, the head
space may provide the sole passageway through which fluid is
transferred from the purging lumens 6263 to the reduced-pressure
lumens 6321. In this embodiment, no interlumen channel 6240 may be
present in the manifold 5815.
[0251] Referring primarily to FIGS. 55 and 56, cross-sectional
views of the reduced-pressure treatment apparatus 5800 are shown
according to an illustrative embodiment. In particular, FIG. 55 is
a cross-sectional view of the transition region 5829 as shown from
the perspective of cross-sectional indicator 56 in FIG. 49. FIG. 56
is a cross-sectional view of the delivery tube 5825 as shown from
the perspective of cross-sectional indicator 56 in FIG. 49.
[0252] The delivery tube 5825 includes fluid delivery lumens 6430
that may deliver fluid to the purging lumens 6263 in FIGS. 53 and
54. The delivery tube 5825 also includes reduced-pressure delivery
lumens 6428 that may deliver reduced pressure to the
reduced-pressure lumens 6321, as well as other parts of the
manifold 5815 and an adjacent tissue site.
[0253] The number of purging lumens 6263 in the manifold 5815 may
exceed the number of fluid delivery lumens 6430 in the delivery
tube 5825. Also, the number of reduced-pressure lumens 6321 in the
manifold 5815 may exceed the number of reduced-pressure delivery
lumens 6428 in the delivery tube 5825. The number of lumens
increases from the delivery tube 5825 to the manifold 5815 in this
manner at the transition region 5829, which acts as the interface
between the delivery tube 5825 and the manifold 5815.
[0254] In one embodiment, the transition region 5829 includes at
least one cavity. In one example, the fluid delivery lumens 6430
may be in fluid communication with the purging lumens 6263 via the
cavity. In this example, the fluid delivery lumens 6430 may be
coupled, or otherwise fluidly connected, to an end of the cavity
that is nearer the delivery tube 5825. The purging lumens 6263 may
be coupled, or otherwise fluidly connected, to an end of the cavity
that is nearer the manifold 5815. Providing a cavity in this manner
permits the number of the fluid delivery lumens 6430 and the
purging lumens 6263 to be varied while still maintaining fluid
communication between them.
[0255] In another example, the reduced-pressure delivery lumens
6428 may be in fluid communication with the reduced-pressure lumens
6321 via the cavity. In this example, the reduced-pressure delivery
lumens 6428 may be coupled, or otherwise fluidly connected, to an
end of the cavity that is nearer the delivery tube 5825. The
reduced-pressure lumens 6321 may be coupled, or otherwise fluidly
connected, to an end of the cavity that is nearer the manifold
5815. Providing a cavity in this manner permits the number of the
reduced-pressure delivery lumens 6428 and the reduced-pressure
lumens 6321 to be varied while still maintaining fluid
communication between them. In addition, the transition region may
include two cavities, one of which provides fluid communication
between the fluid delivery lumens 6430 and the purging lumens 6263,
the other of which provides fluid communication between the
reduced-pressure delivery lumens 6428 and the reduced-pressure
lumens 6321.
[0256] In another embodiment, the transition region 5829 includes
one or more branching or forking pathways that allow fluid
communication between a lesser number of fluid delivery lumens and
a greater number of purging lumens. The transition region 5829 may
also include one or more branching or forking pathways that allow
fluid communication between a lesser number of reduced-pressure
delivery lumens and a greater number of reduced-pressure
lumens.
[0257] Referring primarily to FIGS. 57 and 58, a reduced-pressure
treatment apparatus 6600 is shown according to an illustrative
embodiment. The reduced-pressure treatment apparatus 6600 includes
a manifold 6615, a transition region 6629, and a delivery tube
6625. The reduced-pressure treatment apparatus 6600 delivers
reduced pressure from a reduced-pressure source, such as
reduced-pressure source 5495 in FIG. 48, to a subcutaneous tissue
site through slits 6631 (only one of which is shown in FIGS. 57 and
58). The reduced-pressure treatment apparatus 6600 also includes a
purging function that helps to prevent blockages from forming in
the manifold 6615.
[0258] In contrast to the manifold 5815 in FIGS. 49-53, the
manifold 6615 has a substantially cylindrical shape, as well as a
substantially circular cross-sectional shape. In other embodiments,
the manifold 5815 may have any cross-sectional shape, such as a
substantially rectangular, substantially polygonal, substantially
triangular, substantially elliptical, star, or irregular
cross-sectional shape.
[0259] Referring primarily to FIG. 59, a cross-sectional view of
the manifold 6615 taken along line 59-59 in FIG. 57 is shown
according to an illustrative embodiment. FIG. 59 shows the spatial
orientation of the purging lumens 6863 and the slits 6631.
[0260] In contrast to the slits 5831 in FIGS. 49, 52, and 53, the
slits 6631 are spaced at equal intervals around an outer surface of
the manifold 6615. In particular, the manifold 6615 includes four
slits 6631 that are spaced at ninety degree intervals from one
another. Also, an axis 6852 formed by a first pair of slits is
perpendicular to an axis 6854 formed by a second pair of slits.
Although four slits 6631 are shown on the manifold 6615, the
manifold 6615 may include any number of slits. Also, the slits 6631
may be spaced at non-uniform intervals from one another, or may all
be located on a single side of the manifold 6615.
[0261] Each of the purging lumens 6863 is substantially pie-shaped.
A pie shape may include a triangle modified in that one or more
sides is/are curved. In addition, the purging lumens 6863 are
spaced at equal intervals around a central longitudinal axis 6856
of the manifold 6615. Each of the four purging lumens 6863 are
located in a separate quadrant of the manifold 6615, and are spaced
at ninety degree intervals from one another. An axis 6857 formed by
a first pair of purging lumens is perpendicular to an axis 6858
formed by a second pair of purging lumens. Although four purging
lumens 6863 are shown in the manifold 6615, the manifold 6615 may
include any number of purging lumens. Also, the purging lumens 6863
may be spaced at non-uniform intervals from one another.
[0262] Referring primarily to FIGS. 60 and 61, cross-sectional
views of the reduced-pressure treatment apparatus 6600 are shown
according to an illustrative embodiment. In particular, FIG. 60 is
a cross-sectional view of the transition region 6629 taken along
line 60-60 in FIG. 57. FIG. 61 is a cross-sectional view of the
delivery tube 6625 taken along line 61-61 in FIG. 57.
[0263] The delivery tube 6625 includes fluid delivery lumen 6930
that may deliver fluid to the purging lumens 6863 in FIGS. 59 and
60. The delivery tube 6625 also includes reduced-pressure delivery
lumen 7028 that may deliver reduced pressure to the
reduced-pressure lumens 6921, as well as other parts of the
manifold 6615 and an adjacent tissue site. The reduced-pressure
delivery lumen 7028 is shown to have a larger diameter than the
fluid delivery lumen 6930, although each of these lumens may have
any size relative to one another.
[0264] The number of lumens increases from the delivery tube 6625
to the manifold 6615 at the transition region 6629, which acts as
the interface between the delivery tube 6625 and the manifold
6615.
[0265] Referring primarily to FIGS. 62 and 63, the application of a
manifold 7115 to a subcutaneous tissue site 7105 is shown according
to an illustrative embodiment. The manifold 7115 includes a felt
envelope 7197 that may cover at least a portion of the outer
surface of the manifold 7115 and may serve as a second manifold,
e.g., second manifold 5488 in FIG. 47. In one example, the felt
envelope 7197 may cover a majority or all of the outer surface of
the manifold 7115. The felt envelope 7197 may help to prevent soft
tissue from blocking openings, apertures, or slits in the manifold
7115, and may help to prevent tissue damage when the manifold 7115
is removed from the subcutaneous tissue site 7105.
[0266] In one embodiment, a method for applying reduced pressure to
the subcutaneous tissue site 7105 includes applying the manifold
7115 to the subcutaneous tissue site 7105. The manifold 7115 may be
percutaneously inserted into a patient, and the manifold 7115 may
be positioned adjacent to or abutting the subcutaneous tissue site
7105. The symmetrical design of the manifold included in at least a
portion of the illustrative embodiments may facilitate the
implantation of the manifold in any orientation.
[0267] In the example in which the subcutaneous tissue site 7105
includes a defect, such as a fracture, a scaffold 7196 may be
positioned at the defect site to improve healing and tissue
generation characteristics. The scaffold 7196 may be adjoined to
the subcutaneous tissue site 7105 using a tibial nail 7198.
[0268] The delivery tube 7125 may be used to facilitate placement
of the manifold 7115 at the subcutaneous tissue site 7105. The
delivery tube 7125 may be coupled to a reduced-pressure source via
a purge/reduced-pressure connector 7195.
[0269] In one embodiment, a method of manufacturing an apparatus
for applying reduced pressure to the subcutaneous tissue site 7105
includes forming manifold 7115. The method may also include
providing the delivery tube 7125 and coupling the delivery tube
7125 to the manifold 7115 such that the delivery tube 7125 is in
fluid communication with the manifold 7115.
[0270] Referring now primarily to FIGS. 64-66, another illustrative
embodiment of a reduced-pressure delivery apparatus 7200 is
presented. The reduced-pressure delivery apparatus 7200 includes a
manifold 7202 having a longitudinal manifold body 7204 and having a
first side 7206 and a second, tissue-facing side 7208. The
reduced-pressured delivery apparatus 7200 delivers reduced pressure
from a reduced pressure source, such as reduced-pressure source
5495 in FIG. 49, to a subcutaneous tissue site, such as a bone or
more particularly a vertebrae or multiple vertebra, through a
plurality of apertures 7210 formed on the second, tissue-facing
side 7208 of the longitudinal manifold body 7204. The plurality of
apertures 7210 may be further distributed or manifolded by a
plurality of manifolding surface features 7212, such as a plurality
of recesses 7214 or rounded grooves. The plurality of recesses 7214
may be asymmetrical to facilitate percutaneous removal.
[0271] The plurality of apertures 7210 are associated with the
plurality of manifolding surface features 7212, which help
distribute the reduced pressure. The plurality of apertures 7210
fluidly couple the plurality of manifold surface features 7212 to
an evacuation lumen or reduced-pressure lumen 7216 by conduits
7218. The reduced-pressure lumen 7216 may be one or a plurality of
conduits for delivering reduced pressure and removing fluids. The
reduced-pressure lumen 7216 runs the longitudinal length of the
longitudinal manifold body 7204. The longitudinal manifold body
7204 also contains at least one purging lumen or conduit 7220. The
one or more purging lumens 7220 also run the longitudinal length of
the longitudinal manifold body 7204. At a distal end 7222 of the
manifold 7202 is an end cap 7224. The end cap 7224 may be formed
integrally as part of the longitudinal manifold body 7204.
[0272] The end cap 7224 provides head space (not shown) that allows
the purging fluid within the one or more purging lumens 7220 to be
fluidly coupled to the reduced-pressure lumen 7216. The first side
7206 of the longitudinal manifold body 7204 near the distal end
7222 may also have a plurality of ridges 7226 and second plurality
of recesses 7228.
[0273] A proximal end 7230 out of the longitudinal manifold body
7204 may have a connector 7232 to facilitate connection with a
reduced-pressure delivery tube or conduit 7234. The
reduced-pressure delivery tube 7234 may be a multi-lumen conduit
that provides reduced pressure from the reduced-pressure source to
the reduced-pressure lumen 7216 of the manifold 7202 and provides a
purging fluid to the one or more purging lumens 7220.
[0274] In operation, the reduced-pressure delivery apparatus 7200
is used in a manner analogous to the embodiments previously
presented. Thus, the second, tissue-facing side 7208 of the
manifold 7202 is positioned proximate the tissue site and reduced
pressure is supplied. The reduced pressure is delivered to the
tissue site through the apertures 7210 and the manifolding surface
features 7212. A purging fluid, e.g., air, is used to help remove
or avoid blocking of the reduced pressure lumen 7216 and to prevent
hydrostatic equilibrium.
[0275] Referring now primarily to FIGS. 67-70, another illustrative
embodiment of a reduced-pressure delivery apparatus 7300 is
presented. The reduced-pressure delivery apparatus 7300 includes a
manifold 7302 having a longitudinal manifold body 7304, which has a
first side 7306 and a second, tissue-facing side 7308. The manifold
7302 may be formed by injection molding. Injection molding of the
manifold 7302 may help to avoid portions breaking or being
otherwise at risk of being left in the patient's body. The manifold
7302 may also be extruded into parts and then bonded or otherwise
coupled to form an integral unit. Alternatively, the manifold 7302
may be extruded and then undergo a secondary controlled melt
"tipping" process to form an integral unit. The manifold 7302 may
be made from a flexible or semi-rigid material. For example, the
manifold 7302 may be made from any medical-grade polymer, such as
polyurethane, etc. In one embodiment, the manifold 7302 is made
from a material with a stiffness of approximately 80 Shore A, but
other stiffnesses may be used. A coating may be added to the
manifold 7302 to avoid material buildup on the manifold 7302.
[0276] A plurality of apertures 7310 are formed on the second,
tissue-facing side 7308 of the longitudinal manifold body 7304 for
providing reduced pressure to a subcutaneous tissue site, such as a
bone. While the apertures are shown in a symmetrical space pattern,
it should be understood that the apertures may be formed with any
pattern or with a random placement. A plurality of manifold surface
features 7312 are formed on the second, tissue-facing side 7308.
The plurality of manifold surface features 7312 may include a
plurality of standoffs or offsets 7314. The plurality of offsets
7314 may be formed integrally with or coupled to the second,
tissue-facing side 7308 of the longitudinal manifold body 7304. The
offsets 7314 may be any surface feature creating effective flow
channels between the second, tissue-facing side 7308 and the tissue
site. The surface features 7312 may detach from the manifold body
7304 when the manifold 7302 is percutaneously removed, and the
surface features 7312 may be bioresorbable.
[0277] The apertures 7310 are fluidly coupled to reduced-pressure
lumen 7316 formed in the longitudinal manifold body 7304. The
reduced-pressure lumen 7316 is fluidly coupled to the apertures
7310 by a plurality of conduits 7318. The reduced-pressure lumen
7316 runs the length 7319 of the longitudinal manifold body 7304.
The longitudinal manifold body 7304 is also formed with one or more
purging lumens 7320 which also run the length 7319 of the
longitudinal manifold body 7304. While the illustrative embodiment
shows two purge lumens 7320, it should be understood that any
number may be used. Additionally, the two purge lumens 7320 are
shown symmetrically spaced about the reduced-pressure lumen 7316,
and while the symmetric orientation of the two purge lumen 7320
does enhance performance in that the performance is not degradated
by different orientations, other orientations may be used.
Additional lumens, such as a pressure sensing lumen, may be
included within the longitudinal manifold body 7304.
[0278] On the distal end 7322 of the longitudinal manifold body
7304 an end cap 7324 is formed or coupled. The end cap 7324 is
formed with a header space 7325 that allows the one or more purging
lumens 7320 to be fluidly coupled to the reduced-pressure lumen
7316. The end cap 7324 is formed integrally to the or as part of
the longitudinal manifold body 7304 and thus, avoids the risk of
the end cap becoming dislodged during removal from the patient's
body.
[0279] At the proximal end 7330 of the longitudinal manifold body
7304, a connector 7332 may be coupled to provide easy connection
with a reduced-pressure delivery tube or conduit 7334, which in
turn is fluidly coupled to a reduced pressure source and also a
source of a purging fluid or liquid. The reduced-pressure delivery
tube 7334 may be a multi-lumen conduit that delivers reduced
pressure to the reduced-pressure lumen 7316 and provides the
purging fluid to the one or more purging lumens 7320. The purging
fluid may be, for example, atmospheric air.
[0280] The longitudinal manifold body 7304 has the length 7319 and
a width 7336. Typically a treatment area 7338, which has a
longitudinal length of 7340 is formed close to the distal end 7322.
The longitudinal manifold body 7304 typically has an aspect ratio,
which is the length 7319 divided by the width 7336, that is greater
than five, and typically greater than 10 or even 20 or more. In one
embodiment for a spinal application, the longitudinal length 7340
of the treatment area 7338 is in the range of about 60 to 80
millimeters, but it should be understood that any dimension may be
used depending on the application involved.
[0281] In one illustrative, non-limiting embodiment, the effective
diameter of the lateral cross section of the longitudinal manifold
body 7304 is eight millimeters and in another illustrative
embodiment is eleven millimeters, but it should be understood that
while specific dimensions are given for an example, any size
effective diameter may be used. It should also be noted that
although a slightly elliptical or triangular shape is presented,
the cross sectional shape of the longitudinal manifold body may be
any of those previously mentioned or even irregular or other
shapes.
[0282] In operation, the manifold 7302 may be inserted surgically
or using minimally invasive surgery. Typically, the manifold 7302
would be removed percutaneously or in one embodiment may be
bio-absorbable and left in place.
[0283] The administration of reduced-pressure tissue treatment to a
tissue site in accordance with the systems and methods described
herein may be accomplished by applying a sufficient reduced
pressure to the tissue site and then maintaining that sufficient
reduced pressure over a selected period of time. Alternatively, the
reduced pressure that is applied to the tissue site may be cyclic
in nature. More specifically, the amount of reduced pressure
applied may be varied according to a selected temporal cycle. Still
another method of applying the reduced pressure may vary the amount
of reduced pressure randomly. Similarly, the rate or volume of
fluid delivered to the tissue site may be constant, cyclic, or
random in nature. Fluid delivery, if cyclic, may occur during
application of reduced pressure, or may occur during cyclic periods
in which reduced pressure is not being applied. While the amount of
reduced pressure applied to a tissue site will typically vary
according to the pathology of the tissue site and the circumstances
under which reduced-pressure tissue treatment is administered, the
reduced pressure will typically be between about -5 mm Hg and -500
mm Hg, but more preferably between about -5 mm Hg and -300 mm
Hg.
[0284] While the systems and methods of the present disclosure have
been described with reference to tissue growth and healing in human
patients, it should be recognized that these systems and methods
for applying reduced-pressure tissue treatment can be used in any
living organism in which it is desired to promote tissue growth or
healing. Similarly, the systems and methods of the present
disclosure may be applied to any tissue, including, without
limitation, bone tissue, adipose tissue, muscle tissue, neural
tissue, dermal tissue, vascular tissue, connective tissue,
cartilage, tendons, or ligaments. While the healing of tissue may
be one focus of applying reduced-pressure tissue treatment as
described herein, the application of reduced-pressure tissue
treatment, especially to tissues located beneath a patient's skin,
may also be used to generate tissue growth in tissues that are not
diseased, defective, or damaged. For example, it may be desired to
use the percutaneous implantation techniques to apply
reduced-pressure tissue treatment to grow additional tissue at a
tissue site that can then be harvested. The harvested tissue may be
transplanted to another tissue site to replace diseased or damaged
tissue, or alternatively the harvested tissue may be transplanted
to another patient.
[0285] It is also important to note that the reduced-pressure
delivery apparatuses described herein may be used in conjunction
with scaffold material to increase the growth and growth rate of
new tissue. The scaffold material could be placed between the
tissue site and the reduced-pressure delivery apparatus, or the
reduced-pressure delivery apparatus could itself be made from
bioresorbable material that serves as a scaffold to new tissue
growth.
[0286] Although the present invention and its advantages have been
disclosed in the context of certain illustrative, non-limiting
embodiments, it should be understood that various changes,
substitutions, permutations, and alterations can be made without
departing from the scope of the invention as defined by the
appended claims. It will be appreciated that any feature that is
described in a connection to any one embodiment may also be
applicable to any other embodiment.
* * * * *