U.S. patent application number 11/799355 was filed with the patent office on 2007-09-06 for ultrasound bandage.
Invention is credited to Roger J. Talish, Alan A. Winder.
Application Number | 20070208280 11/799355 |
Document ID | / |
Family ID | 22185059 |
Filed Date | 2007-09-06 |
United States Patent
Application |
20070208280 |
Kind Code |
A1 |
Talish; Roger J. ; et
al. |
September 6, 2007 |
Ultrasound bandage
Abstract
Ultrasound bandages and ultrasound transducer array bandages are
provided herein to accelerate the healing of wounds by positioning
the ultrasound transducer array bandages adjacent to a wound and
generating ultrasonic pulses. The ultrasonic bandages generally
include a backing layer and a transducer material disposed on at
least a portion of the adhesive layer. The ultrasound transducer
array bandages generally include a backing layer and an array
comprising a plurality of transducer materials arranged in adjacent
relation to define spaces therebetween, the array being disposed on
at least a portion of the backing layer.
Inventors: |
Talish; Roger J.;
(Hillsborough, NJ) ; Winder; Alan A.; (Westport,
CT) |
Correspondence
Address: |
CHIEF PATENT COUNSEL;SMITH & NEPHEW, INC.
1450 BROOKS ROAD
MEMPHIS
TN
38116
US
|
Family ID: |
22185059 |
Appl. No.: |
11/799355 |
Filed: |
April 30, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09700014 |
Dec 29, 2000 |
7211060 |
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PCT/US99/09875 |
May 6, 1999 |
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11799355 |
Apr 30, 2007 |
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60084453 |
May 6, 1998 |
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Current U.S.
Class: |
601/2 ; 29/25.35;
602/41 |
Current CPC
Class: |
Y10T 29/42 20150115;
A61H 23/0245 20130101; A61N 7/00 20130101; G10K 11/004 20130101;
A61N 2007/0078 20130101 |
Class at
Publication: |
601/002 ;
029/025.35; 602/041 |
International
Class: |
A61N 7/00 20060101
A61N007/00; A61F 13/00 20060101 A61F013/00; H04R 17/00 20060101
H04R017/00 |
Claims
1. An ultrasound bandage which comprises: a) a backing layer
possessing upper and lower surfaces; and b) a transducer material
comprising a fiber sheet formed from a composition containing a
piezoelectric material.
2. The ultrasound bandage of claim 1 wherein the backing layer is a
polyurethane film.
3. The ultrasound bandage of claim 1 further comprising an adhesive
layer substantially coextensive with the lower surface of the
backing layer, wherein the adhesive layer is fabricated from a
material selected from the group consisting of polyacrylic resin,
polyvinylether resin and polyurethane resin.
4. The ultrasound bandage of claim 1 wherein the fiber sheet is a
fabric woven from one or more fibers containing a piezoelectric
material.
5. The ultrasound bandage of claim 1 wherein the piezoelectric
material is selected from the group consisting of PZT powders,
ceramic, PVDF, lead zirconate titanate Pb(Zr,Ti)O.sub.3. lead
metaniobate Pb(Nb.sub.2O.sub.6) modified lead titanate
PbTi.sub.3,(Pb,Ca)TiO.sub.3, (Pb,Sm)TiO.sub.3, barium titanate
BaTiO.sub.3,
PMN--PT(1-x)Pb(Mg.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3,
PZN--PT/BT
Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3--BaTiO.sub.3,
(1-x)Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-x(yPbTiO.sub.3-(1-y)PbZrO.sub.3)
and mixtures thereof.
6. The ultrasound bandage of claim 1 wherein the fiber sheet is
knitted, braided or woven from extruded fibers containing a
piezoelectric material.
7. The ultrasound bandage of claim 1 wherein the extruded fibers
possess a coating formed thereon.
8. The ultrasound bandage of claim 7 wherein the coating comprises
a film-forming polymer solution.
9. The ultrasound bandage of claim 8 wherein the film-forming
polymer solution contains a mixture of a polyvinyl alcohol and
polyvinyl acetate as a major component thereof and polyethylene
glycol as a minor component thereof.
10. The ultrasound bandage of claim 3 further comprising an
electrode surface applied to, and substantially coextensive with,
opposite surfaces of the transducer material and a matching layer
applied to, and substantially coextensive with, one of the
electrode surfaces.
11. The ultrasound bandage of claim 10 wherein the matching layer
comprises a polymeric material and optionally a filler.
12. The ultrasound bandage of claim 11 wherein the polymeric
material is selected from the group consisting of thermoplastics,
thermosets, rubbers, epoxy and mixtures thereof.
13. The ultrasound bandage of claim 11 wherein the matching layer
includes a filler selected from the group consisting of PZT,
tungsten, alumina, silica glass, tungsten carbide and titanium.
14. The ultrasound bandage of claim 11 wherein the matching layer
includes glass powder as a filler.
15. The ultrasound bandage of claim 11 wherein the matching layer
has an acoustic impedance of from about 2.0 to about 7.0
MRayls.
16. The ultrasound bandage of claim 10 further comprising a
coupling pad applied to, and substantially coextensive with, the
matching layer.
17. The ultrasound bandage of claim 16 wherein the coupling pad is
a hydrogel pad.
18. The ultrasound bandage of claim 16 wherein the coupling pad is
configured as a wedge to direct a longitudinal wave from the
transducer material off-axis for to an internal.
19. The ultrasound bandage of claim 1 further comprising connector
assemblies having connectors and leads, the connectors detachably
connect leads to the transducer material and the leads are coupled
to a portable main operating unit.
20. The ultrasound bandage of claim 18 further comprising a cover
covering the adhesive layer and the coupling pad and being applied
to the adhesive layer.
21. A method for manufacturing an ultrasound bandage which
comprises: a) providing a backing layer possessing upper and lower
surfaces; and b) disposing a transducer material, comprising a
fiber sheet formed from a composition containing a piezoelectric
material, on at least a portion of the backing layer layer.
22. The method of claim 21 wherein the backing layer is a
polyurethane film.
23. The method of claim 21 further comprising applying an adhesive
layer substantially coextensive with the lower surface of the
backing layer, wherein the adhesive layer is fabricated from a
material selected from the group consisting of polyacrylic resin,
polyvinylether resin and polyurethane resin.
24. The method of claim 21 wherein the fiber sheet is a fabric
woven from one or more fibers containing a piezoelectric
material.
25. The method of claim 21 wherein the piezoelectric material is
selected from the group consisting of PZT powders, ceramic, PVDF,
lead zirconate titanate Pb(Zr,Ti)O.sub.3, lead metaniobate
Pb(Nb.sub.2O.sub.6) modified lead titanate PbTi.sub.3,
(Pb,Ca)TiO.sub.3, (Pb,Sm)TiO.sub.3, barium titanate BaTiO.sub.3,
PMN--PT(1-x)Pb(Mg.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3,
PZN--PT/BT
Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3--BaTiO.sub.3,
(1-x)Pb(Zn.sub.13,Nb.sub.2/3)O.sub.3-x(yPbTiO.sub.3-(1-y)PbZrO.sub.3)
and mixtures thereof.
26. The method of claim 21 wherein the extruded fibers possess a
coating formed thereon.
27. The method of claim 26 wherein the coating comprises a
film-forming polymer solution.
28. The method of claim 27 wherein the film-forming polymer
solution contains a mixture of a polyvinyl alcohol and polyvinyl
acetate as a major component thereof and polyethylene glycol as a
minor component thereof.
29. The method of claim 21 further comprising an electrode surface
applied to, and substantially coextensive with, opposite surfaces
of the transducer material and a matching layer applied to, and
substantially coextensive with, one of the electrode surfaces.
30. The method of claim 29 wherein the matching layer comprises a
polymeric material and optionally a filler.
31. The method of claim 30 wherein the polymeric material is
selected from the group consisting of thermoplastics, thermosets,
rubbers, epoxy and mixtures thereof.
32. The method of claim 30 wherein the matching layer includes, a
filler selected from the group consisting of PZT, tungsten,
alumina, silica glass, tungsten carbide and titanium.
33. The method of claim 30 wherein the matching layer includes
glass powder as a filler.
34. The method of claim 30 wherein the matching layer has an
acoustic impedance of from about 2.0 to about 7.0 MRayls.
35. The method of claim 29 further comprising applying a coupling
pad to, and substantially coextensive with, the matching layer.
36. The method of claim 35 wherein the coupling pad is a hydrogel
pad.
37. The method of claim 35 wherein the coupling pad is configured
as a wedge to direct a longitudinal wave from the transducer
material off-axis for to an internal designated reflection site
and/or for modal conversion.
38. The method of claim 21 further comprising connecting connector
assemblies having connectors and leads to the transducer material
of the ultrasonic bandage.
39. An ultrasound transducer array bandage which comprises: a) a
backing layer possessing upper and lower surfaces; b) an array
comprising a plurality of transducer materials arranged in adjacent
relation to define spaces there between, the array being disposed
on at least a portion of the backing layer; and, c) a connector
assembly applied to the array; wherein each transducer material
comprises a fiber sheet formed from a composition containing a
piezoelectric material.
40. The ultrasound transducer array bandage of claim 39 wherein the
backing layer is a polyurethane film.
41. The ultrasound transducer array bandage of claim 39 further
comprising an adhesive layer applied to, and substantially
coextensive with, the lower surface of the backing layer, wherein
the adhesive layer is fabricated from a material selected from the
group consisting of polyacrylic resin, polyvinylether resin and
polyurethane resin.
42. The ultrasound transducer array bandage of claim 39 wherein the
fiber sheet is a fabric woven from one or more extruded fibers
containing a piezoelectric material.
43. The ultrasound transducer array bandage of claim 39 wherein the
piezoelectric material is selected from the group consisting of PZT
powders, ceramic, PVDF, lead zirconate titanate Pb(Zr,Ti)O.sub.3,
lead metaniobate Pb(Nb.sub.2O.sub.6) modified lead titanate
PbTi.sub.3, (Pb,Ca)TiO.sub.3, (Pb,Sm)TiO.sub.3, barium titanate
BaTiO.sub.3,
PMN--PT(1-x)Pb(Mg.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3,
PZN--PT/BT
Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3--BaTiO.sub.3,
(1-x)Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3x(yPbTiO.sub.3-(1-y)PbZrO.sub.3)
and mixtures thereof.
44. The ultrasound transducer array bandage of claim 39 wherein the
fiber sheet is knitted, braided or woven from extruded fibers
containing a piezoelectric material.
45. The ultrasound transducer array bandage of claim 39 wherein the
extruded fibers possess a coating formed thereon.
46. The ultrasound transducer array bandage of claim 45 wherein the
coating comprises a film-forming polymer solution.
47. The ultrasound transducer array bandage of claim 46 wherein the
film-forming polymer solution contains a mixture of a polyvinyl
alcohol and polyvinyl acetate as a major component thereof and
polyethylene glycol as a minor component thereof.
48. The ultrasound transducer array bandage of claim 39 further
comprising an electrode surface applied to, and substantially
coextensive with, opposite surfaces of each transducer material and
a matching layer applied to, and substantially coextensive with,
one of the electrode surfaces.
49. The ultrasound transducer array bandage of claim 48 wherein the
matching layer comprises a polymeric material and optionally a
filler.
50. The ultrasound transducer array bandage of claim 49 wherein the
polymeric material is selected from the group consisting of
thermoplastics, thermosets, rubbers, epoxy and mixtures
thereof.
51. The ultrasound transducer array bandage of claim 49 wherein the
matching layer includes a filler selected from the group consisting
of PZT, tungsten, alumina, silica glass, tungsten carbide and
titanium.
52. The ultrasound transducer array bandage of claim 49 wherein the
matching layer includes glass powder as a filler.
53. The ultrasound bandage of claim 48 wherein the matching layer
has an acoustic impedance of from about 2.0 to about 7.0
MRayls.
54. The ultrasound transducer array bandage of claim 48 further
comprising a coupling pad applied to, and substantially coextensive
with, the matching layer.
55. The ultrasound transducer array bandage of claim 54 wherein the
coupling pad is a hydrogel pad.
56. The ultrasound transducer array bandage of claim 54 wherein the
coupling pad is configured as a wedge to direct a longitudinal wave
from each transducer material off-axis for to an internal
designated reflection site and/or for modal conversion.
57. The ultrasound transducer array bandage of claim 39 wherein the
connector assemblies comprise connectors and leads, the connectors
detachably connect leads to the array and the leads are coupled to
a portable main operating unit.
58. The ultrasound transducer array bandage of claim 41 further
comprising a cover covering the adhesive layer and the coupling pad
and being applied to the adhesive layer.
59. A method for manufacturing an ultrasound transducer array
bandage which comprises: a) providing a backing layer possessing
upper and lower surfaces; b) disposing an array comprising a
plurality of transducer materials arranged in adjacent relation to
define spaces there between on at least a portion of the backing
layer; and, c) applying a connector assembly to the array; wherein
each transducer material comprises a fiber sheet formed from a
composition containing a piezoelectric material.
60. The method of claim 59 wherein the backing layer is a
polyurethane film.
61. The method of claim 59 further comprising applying an adhesive
layer to, and substantially coextensive with, the lower surface of
the backing layer, wherein the adhesive layer is fabricated from a
material selected from the group consisting of polyacrylic resin,
polyvinylether resin and polyurethane resin.
62. The method of claim 59 wherein the piezoelectric material is
selected from the group consisting of PZT powders, ceramic, PVDF,
lead zirconate titanate Pb(Zr,Ti)O.sub.3, lead metaniobate
Pb(Nb.sub.2O.sub.6) modified lead titanate PbTi.sub.3,
(Pb,Ca)TiO.sub.3, (Pb,Sm)TiO.sub.3, barium titanate BaTiO.sub.3,
PMN--PT(1-x)Pb(Mg.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3,
PZN--PT/BT
Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3--BaTiO.sub.3,
(1-x)Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-x(yPbTiO.sub.3-(1-y)PbZrO.sub.3)
and mixtures thereof.
63. The method of claim 59 wherein the fiber sheet is a fabric
woven from one or more fibers containing a piezoelectric
material.
64. The method of claim 59 further comprising the step of forming
the fiber sheet by knitting, braiding or weaving the extruded
fibers.
65. The method of claim 64 further comprising applying a coating to
the extruded fibers prior to forming the fiber sheet.
66. The method of claim 65 wherein the coating comprises a
film-forming polymer solution.
67. The method of claim 66 wherein the film-forming polymer
solution contains a mixture of a polyvinyl alcohol and polyvinyl
acetate as a major component thereof and polyethylene glycol as a
minor component thereof.
68. The method of claim 67 further comprising an electrode surface
applied to, and substantially coextensive with, opposite surfaces
of each transducer material and a matching layer applied to, and
substantially coextensive with, one of the electrode surfaces.
69. The method of claim 68 wherein the matching layer comprises a
polymeric material and optionally a filler.
70. The method of claim 69 wherein the polymeric material is
selected from the group consisting of thermoplastics, thermosets,
rubbers, epoxy and mixtures thereof.
71. The method of claim 69 wherein the matching layer includes a
filler selected from the group consisting of PZT, tungsten,
alumina, silica glass, tungsten carbide and titanium.
72. The method of claim 69 wherein the matching layer includes
glass powder as a filler.
73. The ultrasound bandage of claim 68 wherein the matching layer
has an acoustic impedance of from about 2.0 to about 7.0
MRayls.
74. The method of claim 68 further comprising applying a coupling
pad to, and substantially coextensive with, the matching layer.
75. The method of claim 74 wherein the coupling pad is a hydrogel
pad.
76. The method of claim 74 wherein the coupling pad is configured
as a wedge to direct a longitudinal wave from each transducer
material off-axis for to an internal designated reflection site
and/or for modal conversion.
77. The method of claim 59 wherein the connector assemblies
comprise connectors and leads.
78. A method for accelerating the healing of wounds comprising: a)
positioning at least one ultrasound bandage adjacent to a body at
the site of a wound; b) the ultrasound bandage comprising: i) a
backing layer possessing upper and lower surfaces; and, ii) a
transducer material disposed on at least a portion of the backing
layer, wherein the transducer material comprises a fiber sheet
formed from a composition containing a piezoelectric material; and,
c) causing the transducer material to generate ultrasonic
pulses.
79. The method of claim 78 wherein at least one ultrasound bandage
is positioned adjacent to a body at a plurality of sites of
wounds.
80. The method of claim 78 further comprising applying an electrode
surface to, and substantially coextensive with, opposite surfaces
of the transducer material, applying a matching layer to, and
substantially coextensive with, one of the electrode surfaces and
applying a coupling pad configured as a wedge to the matching
layer.
81. A method for accelerating the healing of wounds comprising: a)
positioning at least one ultrasound transducer array bandage
adjacent to a body at the site of a wound; b) the ultrasound
transducer array bandage comprising: i) a backing layer possessing
upper and lower surfaces; and, ii) an array comprising a plurality
of transducer materials arranged in adjacent relation to define
spaces there between, the array being disposed on at least a
portion of the adhesive layer, wherein the transducer material
comprises a fiber sheet formed from a composition containing a
piezoelectric material, and, c) causing the plurality of transducer
materials to generate ultrasonic pulses.
82. The method of claim 81 wherein at least one ultrasound
transducer array bandage is positioned adjacent to a body at a
plurality of sites of wounds.
83. The method of claim 81 further comprising applying an electrode
surface to, and substantially coextensive with, opposite surfaces
of each transducer material, applying a matching layer to, and
substantially coextensive with, one of the electrode surfaces and
applying a coupling pad configured as a wedge to the matching
layer.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 09/700,014 to Talish et al., filed Dec. 29, 2000, which claims
the benefit of PCT Application WO 99/56829, PCT/US99/09875, filed
May 6, 1999, entitled ULTRASOUND BANDAGE, the contents of which are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Novel ultrasound bandages and ultrasound transducer array
bandages are described herein. Also described are methods for
manufacturing the ultrasound bandages and ultrasound transducer
array bandages. Additionally, use of the ultrasound bandages and
ultrasound transducer array bandages in medical therapeutic
ultrasound applications, e.g., for promoting the healing of wounds,
i.e., wound healing, such as abrasions, lacerations, incisions and
venous ulcers, are also described herein.
[0004] 2. Description of the Related Art
[0005] The therapeutic value of ultrasonic waves is known. For
example, U.S. Pat. No. 4,530,360 to Duarte describes a basic
non-invasive therapeutic technique and apparatus for applying
ultrasonic pulses externally on the skin of the patient at a
location adjacent to a bone fracture site. The applicator described
in the '360 patent has a plastic tube which serves as a grip for
the operator, an RF plug attached to the plastic tube for
connection to an RF source, and internal cabling connected to a
rigid ultrasonic transducer. To apply the ultrasonic pulses during
treatment, an operator manually holds the applicator in place until
the treatment is complete. The '360 patent also describes a range
of RF signals for creating the ultrasound, ultrasound power density
levels, a range of duration for each ultrasonic pulse, and a range
of ultrasonic pulse frequencies.
[0006] As another example, U.S. Pat. Nos. 5,003,965 and 5,186,162,
both to Talish and Lifshey, describe an ultrasonic body treatment
system in which the RF generator and transducer are both part of a
modular applicator unit which is placed at the skin location. Both
the '965 and '162 patents are concerned with healing, for example,
bone fractures by placing the body treatment system within a cast
and then surrounding the treatment site with the cast.
[0007] Yet another example is U.S. Pat. No. 5,211,160 to Talish and
Lifshey which describes a bandage assembly which is mounted on
uncovered body parts, i.e., without a cast or other medical
wrapping. The bandage assembly is typically wrapped around the
region of the body, e.g., the leg, being subjected to ultrasonic
therapy with a treatment head unit containing an ultrasonic
transducer being removably assembled to the bandage assembly during
treatment.
[0008] While these prior art systems provide accelerative healing
of soft tissue wounds and bone fractures, none of the systems
provide an ultrasound bandage having an adhesive layer with a
transducer material disposed thereon for treatment of wounds.
[0009] Previous attempts have been made to provide a bandage having
a transducer material. For example, U.S. Pat. No. 4,787,888
discloses a bandage assembly for percutaneous administration of a
medicament. The bandage assembly described in the '888 patent has a
bandage member with a cavity containing a medicament and having two
transducer materials, e.g., piezoelectric polymers, extending
thereacross with a pair of electrical contacts disposed adjacent
the opposite surfaces of the transducer material. The transducer
materials, however, are employed to produce sonic vibrations in the
material from a sonic generator to stretch the pores of the skin
thereby inducing the medicament into the pores for therapeutic
treatment.
[0010] It would be desirable to provide an ultrasound bandage
having an adhesive layer with a transducer material disposed on at
least a portion thereof such that the bandage can be applied to the
portion of the skin at or near a wound by way of the adhesive layer
and the transducer material facilitating the transfer of acoustic
energy during each therapeutic application to promote the healing
of the wound with the ultrasound bandage being discarded upon
completion of each application.
SUMMARY OF THE INVENTION
[0011] Novel ultrasound bandages and ultrasound transducer array
bandages for use in therapeutic applications have been discovered.
In one embodiment, the novel ultrasound bandages include at least a
backing layer, an adhesive layer applied to, and substantially
coextensive with, the backing layer, and a transducer material
disposed on at least a portion of the adhesive layer. Electrode
surfaces can be applied to opposite surfaces of the transducer
material with a matching layer being applied to, and substantially
coextensive with, the electrode surface not applied to the adhesive
layer. A coupling pad can then be applied to, and substantially
coextensive with, the matching layer.
[0012] In another embodiment, an ultrasound transducer array
bandage is formed by disposing on at least a portion of an adhesive
layer which is applied to, and substantially coextensive with, a
backing layer, an array comprised of a plurality of transducer
materials arranged in adjacent relation to define spaces
therebetween. Electrode surfaces ban be applied to opposite
surfaces of each transducer material with a matching layer being
applied to, and substantially coextensive with, the electrode
surface not applied to the adhesive layer. A coupling pad can then
be applied to, and substantially coextensive with, the array.
[0013] A method for making the ultrasound bandage has also been
discovered. In the method, an adhesive layer is applied to, and
substantially coextensive with, a backing layer, and a transducer
material is disposed on at least a portion of the adhesive
layer.
[0014] A method for making an ultrasound transducer array bandage
has also been discovered. In the method, an adhesive layer is
applied to, and substantially coextensive with, a backing layer, a
plurality of transducer materials are arranged in adjacent relation
to define spaces therebetween to form an array, the array being
disposed on at least a portion of the adhesive layer, and,
optionally, a coupling pad is applied to, and substantially
coextensive with, the array.
[0015] A method for using the ultrasound bandage or ultrasound
transducer array bandage in therapeutic applications has also been
discovered. In the method, the ultrasound bandage or ultrasound
transducer array bandage can be applied to a wound on the human
anatomy or, alternatively, adjacent to the wound, in need of
therapeutic stimulation and that section of the human anatomy is
then exposed to a dosage amount of acoustic energy.
[0016] The term "wound" for the purposes of "wound healing" shall
be understood herein to include ulcers such as venous ulcers,
burns, ulcerated wounds due to, for example, diabetes, incisions
such as surgical incisions or other surgical cuttings including
stitched surgical cuttings, skin grafts, hair transplants,
revascularization, bed sores, tissue dehiscence, ligament and
tendon repair and reconstruction, abrasions and lacerations.
[0017] The ultrasound bandages and ultrasound transducer array
bandages described herein possess at least an adhesive layer having
at least one transducer material disposed on at least a portion
thereof to advantageously permit acoustic energy generated by the
transducer(s) to be efficiently applied and coupled to the contours
of the human anatomy for therapeutic applications. Additionally,
after each application of therapeutic treatment, the ultrasound
bandages and ultrasound transducer array bandages can be
conveniently discarded with a new bandage being applied to the
human anatomy for the next therapeutic application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Preferred embodiments of the invention are described below
with reference to the drawings, which are described as follows:
[0019] FIG. 1 is a schematic cross-sectional view of an ultrasound
bandage in accordance with the present invention;
[0020] FIG. 2A is a schematic cross-sectional view of the
ultrasound bandage of FIG. 1 with a thicker coupling material;
[0021] FIG. 2B is a schematic transverse cross-sectional view of
the ultrasound bandage of FIG. 2A taken along axis 2B-2B
illustrating the coupling material configured as a wedge;
[0022] FIG. 3 is a schematic top view of the ultrasound bandage of
FIG. 1 in an assembly;
[0023] FIG. 4 schematic side view of the ultrasound bandage
assembly of FIG. 3 in accordance with the present invention;
[0024] FIG. 5 schematic cross-sectional view of a ultrasound
transducer array bandage in accordance with the present
invention;
[0025] FIG. 6A is a schematic cross-sectional view of the
ultrasound transducer array bandage of FIG. 5 with a thicker
coupling material;
[0026] FIG. 6B is a schematic transverse cross-sectional view of
the ultrasound transducer array bandage of FIG. 6A taken along axis
6B-6B illustrating the coupling material configured as a wedge;
[0027] FIG. 7 is a schematic top view of the ultrasound transducer
array bandage of FIG. 5 in an assembly;
[0028] FIG. 8 is a schematic top view of ultrasound bandage
possessing indicia thereon;
[0029] FIG. 9 is a perspective view of the ultrasound bandage
assembly of FIG. 3 in use in accordance with the present invention;
and,
[0030] FIG. 10 is a perspective view of the ultrasound transducer
array bandage of FIG. 5 in use in accordance with the present
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0031] One embodiment of an ultrasound bandage in accordance with
the present invention is shown generally in FIG. 1 at 10. In
general, the ultrasound bandage includes a backing layer 12
possessing upper and lower surfaces. Adhesive layer 14 is applied
to, and substantially coextensive with, lower surface 13 of backing
layer 12 for securing the ultrasound bandage 10 to the skin of the
patient. Transducer material 16 can be disposed on at least a
portion of adhesive layer 14 or, alternatively, transducer material
16 can be applied within at least a portion of adhesive layer 14.
In this way, transducer material 16 can be removed, if desired,
prior to disposal of ultrasound bandage 10 after use. Electrode
surfaces 19a and 19b can be applied to, and substantially
coextensive with, opposite surfaces of transducer material 16.
Matching layer 15 can be applied to, and substantially coextensive
with, electrode surface 19b. Coupling pad 18 can be applied to, and
substantially coextensive with, matching layer 15, thereby
providing an efficient coupling path between the transducer
material 16 and the patient's skin and soft tissue for delivery of
acoustic energy to the wound in need of therapeutic treatment.
Alternatively, coupling pad 18 can include end portions (not shown)
which extend beyond and fold over matching layer 15 to adhere to
adhesive layer 14. Release liners 17a and 17b seal and protect
adhesive layer 14, transducer material 16 and coupling pad 18
during the residency of ultrasound bandage 10 within its package
with release liner 17a overlapping release liner 17b.
[0032] In general, backing layer 12 can be any material, woven or
non-woven, synthetic or natural, porous or non-porous, perforated
or non-perforated, elastic or non-elastic, which will provide
support and act as a protective covering for the bandage 10.
Suitable materials include, for example, cellophane, cellulose
acetate, ethyl cellulose, plasticized vinyl acetate-vinyl chloride
copolymers, ethylene-vinyl acetate copolymer, polyethylene
terephthalate, nylon, polyethylene, polypropylene, polyvinylidene,
chloride, paper, cloth, aluminum foil and the like. Preferably,
backing layer 12 is a moisture vapor permeable, liquid impermeable
flexible thin film or sheet with the thin film being more
preferred. A preferred thin film for use herein is a polyurethane
film. If desired, the backing layer 12 can be fabricated from a
composite of films. The composite can be a metallized, e.g.,
aluminized, film or a laminate of two or more films or a
combination thereof. For example, a laminate of polyethylene
terephthalate and polyethylene or a polyethylene/metallized
polyethylene terephthalate/polyethylene laminate can be employed.
Useful polymers include polyethylene, polypropylene, polyvinyl
chloride, polyethylene terephthalate and the like. The width and
thickness of backing layer 12 will vary according to the size of
the bandage employed and are conventional in the art. Therefore,
these widths and thicknesses need not be discussed in detail
herein.
[0033] Adhesive layer 14 of bandage 10 is preferably a pressure
sensitive adhesive layer and can be selected from any of the known
and conventional medical grade adhesives, e.g., those based on
polyacrylic, polyvinylether, or polyurethane resins. Useful
pressure sensitive adhesives include those disclosed in U.S. Pat.
No. 4,573,996, the contents of which are incorporated by reference
herein. It is an essential requirement that the amount of adhesive
layer 14 applied to lower surface 13 of backing layer 12 be
sufficient to achieve an acceptable level of adhesion of ultrasound
bandage 10 to the skin and to apply and adhere transducers 16.
Thus, the various shapes and sizes of adhesive layer 14 will
depend, for example, on the area of a patient's body to which they
are applied, the size and weight of transducer material 16, the
size and shape of the external wound, etc. The amount of adhesive
that will satisfy this criteria can be readily determined by simple
and routine testing. Ordinarily, a medical grade adhesive applied
to a thickness ranging from about 1.0 mils to about 3.5 mils and
preferably from about 2.0 mils to about 2.5 mils (depending, of
course, on the thickness of the backing layer) will meet this
requirement reasonably well. Adhesive layer 14 may include holes or
a permeable material to allow moisture to escape and provide oxygen
to the skin.
[0034] Transducer material 16 can be formed from any transducer
material known to one skilled in the art, e.g., an air backed
quarter wave matched transducer material, polyvinyledene fluoride
material (PVDF), etc. Preferably, transducer material 16 can be
those disclosed in International PCT Application No.
PCT/US99/06650, filed on Mar. 26, 1999, the contents of which are
incorporated by reference herein. For example, transducer material
16 can be formed from one or more fibers extruded from a
composition containing a piezoelectric material. The extruded
fibers can be knitted, woven or braided in 1, 2 or 3 dimensions to
provide a structure that includes spaces which can be filled with a
polymeric material to form a composite. Fibers made of
piezoelectric material suitable for use herein can be prepared, for
example, by using a viscous suspension spinning process and are
available from Advanced Cerametrics Incorporated (Lambertville,
N.J.). Suitable piezoelectric materials for use in the fibers
include PZT powders commercially available from Morgan Matroc,
Inc., ceramic, lead zirconate titanate Pb(Zr,Ti)O.sub.3, lead
metaniobate Pb(Nb.sub.2O.sub.6), modified lead titanate PbTi.sub.3
such as (Pb,Ca)TiO.sub.3 and (Pb,Sm)TiO.sub.3, barium titanate
BaTiO.sub.3,
PMN--PT(1x)Pb(Mg.sub.1/3,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3,
PZN--PT/BT
Pb(Zn.sub.1/3,.sub.h,Nb.sub.2/3)O.sub.3-xPbTiO.sub.3--BaTiO.sub.3,
(1-x)Pb(Zn.sub.1/3,Nb.sub.2/3)O.sub.3-x(yPbTiO.sub.3-(1-y)PbZrO.sub.3)
and the like. In particularly useful embodiments, the extruded
fibers are knitted, woven, braided or non-woven to form a fiber
sheet. Preferably, a simple woven fabric is used as the fiber
sheet. Optionally, the individual fibers in the fiber sheets can be
coated with a film-forming polymer solution to improve the strength
and wear resistance of the individual fibers prior to weaving,
knitting and braiding. Suitable solutions of film-forming material
are known to those in the textile art. By way of example, the
solution can contain a mixture of a polyvinyl alcohol and polyvinyl
acetate as a major component thereof and polyethylene glycol as a
minor component thereof.
[0035] Transducer material 16 can be of varying shapes and sizes
depending, of course, on the size of the wound to be treated. This
can be determined according to simple and routine experimental
testing. Ordinarily, the thickness of transducer material 16 will
range from about 0.1 mils to about 5 mils and preferably from about
1.5 mils to about 3.0 mils with the width of material 16 ranging
from about 0.1 inch to about 1.5 inches and preferably from about
0.5 inch to about 1 inch.
[0036] Electrode surfaces 19a and 19b are applied to opposite
surfaces of transducer material 16. Typically, electrode surface
19a will be applied onto one surface of the transducer material by
techniques known to one skilled in the art, e.g., utilizing
photolithographic techniques. In general, electrode surface 19b
will be applied to, and substantially coextensive with, the other
surface of the transducer material. Electroding can be achieved
employing techniques known to one skilled in the art, e.g.,
sputtering, painting. Materials useful in forming the electrode
surfaces include copper, silver, nickel, gold, alloys, mixtures
thereof and the like. Typically, electrode surface 19a will be
positively charged and the other electrode surface 19b will serve
as a ground.
[0037] Once electrode surfaces 19a and 19b have been applied,
matching layer 15 can then be applied to, and substantially
coextensive with, electrode surface 19b. Techniques for applying
the matching layer are within the purview of one skilled in the
art. Generally, the thickness of the matching layer can be chosen
to correspond to one-quarter of the wavelength in the matching
layer at the operating frequency of the transducer array. The
acoustic impedance of the matching layer will preferably range from
about 2.0 to about 7.0 MRayls.
[0038] Matching layer 15 will ordinarily be formed from a polymeric
material, and optionally, a filler. The polymeric material should
have good compatibility with the components of the composite,
biocompatibility and flexibility. Useful polymeric materials
include thermoplastics such as high density polyethylenes,
polymethyl methacrylates, polypropylenes, polybutylene
terephthalates, polycarbonates, polyurethanes such as CA 118 and CA
128 available from Morton Chemical and estane polyester, and the
like; thermosets such as epoxies such as Spurr epoxy and Stycast
80, and the like; and rubbers such as silicone rubbers such as
dispersion 236 available from Dow Corning and RTV-141 available
from Rhone-Poulenc, Inc. and the like. A preferred polymeric
material for use herein is Stycast 1365-65. Because the acoustic
impedance of many polymeric materials is less than the preferred
range of 2.0-7.0 MRayls, it is necessary to increase the acoustic
impedance of the polymer. Accordingly, one or more fillers can be
incorporated therein. Suitable fillers include PZT, tungsten,
alumina, silica glass, tungsten carbide, titanium, glass powder and
the like with glass powder being preferred. The size of the filler
particles should be in the range of about 0.1 to about 50 microns
and preferably from about 0.5 to about 5 microns. The amount of
filler employed will be that amount necessary to impart the desired
acoustic impedance. Normally, from about 2 to about 50 percent
filler by volume and preferably from about 5 to about 30 volume
percent filler is employed.
[0039] Coupling pad 18 can be selected from any coupling material
known to one skilled in the art. A preferred coupling material for
use herein is a hydrogel pad. Coupling pad 18 can have a
substantially planar surface as depicted in FIG. 1. Alternatively,
coupling pad 18 can be configured, for example, as a wedge, i.e.,
possessing a non-planar surface, as depicted in FIG. 2A and FIG.
2B. Thus, when employing a coupling pad 18 configured as, for
example, a wedge, the longitudinal waves are to be transmitted from
the transducer off-axis, at an angle equal to or slightly greater
than the critical angle, depending on Poisson's ratio for soft
tissue, where the longitudinal waves are converted completely into
shear waves (modal conversion) for therapeutic ultrasonic
stimulation and treatment at the site of the wound.
[0040] Since the delivery of ultrasound to a target injury requires
an efficient coupling path between the transducer material and the
patient's skin and soft tissue, a material for ultrasound coupling
is typically employed to effect a proper interface for propagating
acoustic energy into the patient's body. Commonly used materials
include sonically conductive materials such as, for example,
glycerol, water, oils, lotions, etc., which are applied onto the
coupling pad prior to bandage 10 being placed on the patient's
body.
[0041] Ultrasound bandage 10 is typically employed in an ultrasound
bandage assembly as generally depicted in FIG. 3. Ultrasound
bandage assembly 20 will include at least one or more ultrasound
bandages 10 having connector assemblies 24 with leads 26 for
coupling ultrasound transducers 16 to a portable main operating
unit (MOU). Connector assemblies 24 include detachable connectors
22 for detachably connecting leads 26 to transducers 16 which is
mounted on adhesive layer 14 (see FIG. 4). Connectors 22 are
operatively coupled to transducers 16 and are preferably of the
quick-connected type such that leads 26 may be detached and reused
while ultrasound bandages 10 can be disposed of. The MOU supplies
powers and provides signals for controlling transducers 16. In one
embodiment, the MOU can be a commercially available device such as,
for example, an SAFHS 2000 available commercially from Exogen, Inc.
(Piscataway, N.J.). A preferred MOU is described in further detail
in U.S. application Ser. No. 09/040,157 which is incorporated by
reference herein. The MOU preferably includes a processor which
could be a microprocessor used in conjunction with transducers 16.
The processor generates control signals which are amplified by an
output driver to the desired power level and imparted to the
transducers 16.
[0042] The ultrasound transducer array bandages of the present
invention can be obtained by forming an array of a plurality of the
foregoing transducer materials. The transducer array bandage 30 can
be formed, for example, by disposing an arrangement of transducer
materials 32 in adjacent relation to one another to define spaces
34 therebetween as generally depicted in FIG. 5. It is to be
understood that the transducer materials 32 can be of varying sizes
when forming the array bandage described herein. In general, the
transducer materials 32 can be placed close together or spaced
further apart and the spacings need not be uniform or in perfect
alignment.
[0043] The transducer materials 32 are disposed on or within at
least a portion of adhesive layer 36 which is applied to, and
substantially coextensive with, backing layer 38. Useful materials
for forming backing layer 38 and adhesive layer 36 can be any of
the aforementioned materials. Typically, the spaces between
transducer materials 32 will range from about 0.5 mm to about 10 mm
and preferably from about 1 mm to about 3 mm. The dimensions of the
array will ordinarily range from about 0.5 inch to about 6 inches
wide and from about 0.5 inch to about 12 inches long. The thickness
of the array can effect the frequency of operation and will
ordinarily range from about 0.05 mm to about 10 mm. It should, of
course, be understood that the array can include transducer
materials with different frequencies of operation. These
differences in frequency of operation can be achieved by employing
transducer materials of different thicknesses.
[0044] Electrode surfaces 39a and 39b can be applied to, and
substantially coextensive with, each transducer material 32 in the
array. Once the electrode surfaces have been applied, matching
layers 33 can then be applied to, and substantially coextensive
with, electrode surfaces 39b. Useful materials for forming the
electrode surfaces and the matching layer can be any of the
aforementioned materials.
[0045] Coupling pad 35 can be, for example, a hydrogel pad, and is
typically applied to, and substantially coextensive with, each
matching layer 33, i.e., the array. Alternatively, coupling pad 35
can be applied to, and substantially coextensive with, each
matching layer 33 (not shown). In use, coupling pad 35 can have a
substantially planar surface as depicted in FIG. 5. Alternatively,
coupling pad 35 can be configured, for example, as a wedge, i.e.,
possessing a non-planar surface, as depicted in FIG. 6A and FIG.
6B. Thus, when employing a coupling pad 35 configured as, for
example, a wedge, the longitudinal waves are to be transmitted from
the transducers off-axis, at an angle equal to or slightly greater
than the critical angle, depending on Poisson's ratio for soft
tissue, where the longitudinal waves are converted completely into
shear waves (modal conversion) for therapeutic ultrasonic
stimulation and treatment at the site of the wound. Release liners
37a and 37b seal and protect adhesive layer 36, transducer
materials 32 and coupling pad 35 during the residency of ultrasound
transducer array bandage 30 within its package with release liner
37a overlapping release liner 37b.
[0046] Once the ultrasound transducer array bandage 30 has been
formed, connector assemblies 40 with leads 42 for coupling
ultrasound transducers 32 to a portable main operating unit (MOU)
are applied to the transducers 32 to form an ultrasound transducer
array bandage assembly 44 as generally depicted in FIG. 7.
Connector assemblies 40 include detachable connectors 48 for
detachably connecting leads 42 to transducers 32 which is mounted
on adhesive layer 36. Connectors 48 are operatively coupled to
transducers 32 and are preferably of the quick-connected type such
that leads 42 may be detached and reused while ultrasound
transducer array bandages 44 can be disposed of.
[0047] The ultrasound bandages and ultrasound transducer array
bandages of this invention can also possess a protective covering
(not shown) instead of release liners 17a and 17b and 37a and 37b,
respectively. Covers of this kind are known from U.S. Pat. No.
4,627,429, the contents of which are incorporated by reference
herein. In general, the protective covering can be made, for
example, of a heat-sealable aluminum foil film laminate with the
heat-sealable surface down. A formed cup, dome or square in the
cover allows room for the transducer materials and coupling pad
with the other portion of the cover being placed over the adhesive
layer.
[0048] The ultrasound bandages and ultrasound transducer array
bandages of this invention can be manufactured in a variety of
sizes and shapes, e.g., rectangular, oval, etc., and can be planar
or three-dimensional. Additionally, the ultrasound bandages and
ultrasound transducer array bandages used herein can contain
indicia thereon, e.g., text, color, etc., to indicate the direction
of the transducer so that the ultrasonic waves can be directed
toward the wound as depicted in FIG. 8.
[0049] The ultrasound bandages and ultrasound transducer array
bandages of this invention are particularly useful in therapeutic
applications. In general, the foregoing bandages will be applied
adjacent to, or directly over, the wound to facilitate the transfer
of acoustic energy to promote the healing of wounds. As noted
above, the term "wound" as used herein has a broad meaning as
generally encompassing addressing damage to, and repair of, or
restoration of soft tissue or wounds to the skin such as abrasions
and lacerations. The present invention can be used, for example, to
prevent surgical adhesions by stimulating the proper repair of
surgical incisions. It can also prevent or arrest wound dehiscence
by promoting vascularization at the surfaces adjacent surgical
incisions. It can also be used in cosmetic surgery, for example, by
enhancing the healing of hair transplants, or by directly
stimulating regeneration of cells.
[0050] In general, once the acoustic energy enters the body, it
passes into internal body tissue and/or fluids. The acoustic
energy, in the form of ultrasonic pulses, is reflected off the
surface of underlying bone or other ultrasound reflective material
and the reflected ultrasound travels toward at least part of the
internal surface or underside of the wound. Healing of the wound at
the internal surface by the generation of epithelial cells is
enhanced via the acoustic stimulation.
[0051] Preferably, a low frequency signal which is present as the
modulation of the carrier frequency is transmitted as a
longitudinal acoustic wave from the transducer material, through
interposed soft tissue, and onto the surface of the bone. The
longitudinal wave incident on the bone surface, or other designated
reflection sites in the body, is reflected toward the internal
surface of the wound as longitudinal and/or shear waves. These
reflected waves flooding a region of the internal surface of the
wound increase vascularization at the internal surface of the wound
thus enhancing growth of epithelial cells. The epithelial cell
growth represents healing of the wound. The technique thus promotes
healing of the wound from the internal surface of the wound.
[0052] The number, position and size of ultrasonic bandages used at
the external skin location are chosen based on the size and
position of the wound and the relative position and proximity of
the bone from which the ultrasonic waves are reflected. Thus, more
than one ultrasound bandage or ultrasound transducer array bandage
can be employed at the site of the wound. For example, bandages 10
can be employed about a wound 50 on a body 52 and positioned and
configured to provide enhanced healing treatment to wound 50 as
generally depicted in FIG. 9 and FIG. 10. A portable MOU is shown
for providing power and control to transducers 16 via connectors
26. Additionally, for example, ultrasound transducer array bandage
30 having a plurality of transducer materials 32 can be disposed
over a wound 54 on a body 56 for treatment thereof with a portable
MOU connected thereto.
[0053] Typically, the frequency of the acoustic energy applied
during treatment will be in the range of from about 20 kHz to about
10 MHZ and preferably from about 0.5 to about 5 MHZ. Features
characterizing the frequency of the acoustic energy are disclosed
in U.S. Pat. No. 5,520,612, the contents of which are incorporated
by reference herein. It is to be understood that multiple sections
of the human anatomy can be treated with multiple ultrasound
bandages or ultrasound transducer array bandages at the same time.
Thus, for example, in the case of an individual suffering from both
an abrasion to the arm and an abrasion to the leg, an ultrasound
bandage or ultrasound transducer array bandage can be applied to
the arm while a second ultrasound bandage or ultrasound transducer
array bandage is being applied to the section of the leg suffering
from the wound. The transmit frequency and acoustic energy applied
to each section can vary according to the foregoing ranges.
[0054] When applying the foregoing bandages to the section of the
human anatomy in need of therapeutic assistance, it is advantageous
to apply a coupling gel to the transducer material prior to its
employment on the part of the body. Additionally, when employing
the foregoing ultrasound transducer array bandages, it may be
desirable in certain cases to use selective energization of the
transducer materials in the array such that certain elements will
generate acoustic energy while other elements will not. This will
permit the spatial, temporal, and frequency control of the
distribution of acoustic energy in the body. Techniques for
altering the acoustic energy of the transducer materials are
disclosed in U.S. Pat. No. 5,520,612.
[0055] Although the present invention has been described in
preferred forms with a certain degree of particularity, many
changes and variations are possible therein and will be apparent to
those skilled in the art after reading the foregoing description.
It is therefore to be understood that the present invention may be
practiced otherwise than as specifically described herein without
departing from the spirit and scope thereof.
* * * * *