Delivery-and-fluid-storage bridges for use with reduced-pressure systems
10279088 ยท 2019-05-07
Assignee
Inventors
- Richard Daniel John COULTHARD (Verwood, GB)
- Christopher Brian Locke (Bournemouth, GB)
- Shannon C. INGRAM (Bulverde, TX, US)
- Timothy Mark Robinson (Basingstoke, GB)
Cpc classification
A61M1/915
HUMAN NECESSITIES
A61M2205/3344
HUMAN NECESSITIES
A61F13/0206
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
A61M1/913
HUMAN NECESSITIES
Y10T29/49826
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61M1/962
HUMAN NECESSITIES
A61M1/73
HUMAN NECESSITIES
A61M2205/7536
HUMAN NECESSITIES
A61M1/966
HUMAN NECESSITIES
A61M2205/3379
HUMAN NECESSITIES
A61F13/0223
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
A61M1/982
HUMAN NECESSITIES
International classification
Abstract
Systems, methods, and apparatuses are presented that facilitate the provision of reduced pressure to a tissue site by using a delivery-and-fluid-storage bridge, which separates liquids and gases and provides a flow path for reduced pressure. In one instance, a delivery-and-fluid-storage bridge includes a delivery manifold for delivering reduced pressure to a treatment manifold at the tissue site and an absorbent layer proximate the delivery manifold adapted to receive and absorb liquids. The delivery manifold and the absorbent layer are encapsulated in an encapsulating pouch. A first aperture is formed proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifold from a reduced-pressure source, and a second aperture is formed on a patient-facing side of the delivery-and-fluid-storage bridge. Reduced pressure is transferred to the tissue site via the second aperture. Other systems, apparatuses, and methods are disclosed.
Claims
1. A delivery-and-fluid-storage bridge, comprising: a delivery manifold extending along a length of the delivery-and-fluid-storage bridge for delivering reduced pressure through the delivery-and-fluid-storage bridge; an absorbent layer proximate the delivery manifold adapted to receive and store fluids, wherein the absorbent layer has an outer surface and an interior portion, the delivery manifold has an outer surface and an interior portion, and the outer surface of the delivery manifold is configured to be adjacent to the outer surface of the absorbent layer; a first encapsulating layer and a second encapsulating layer having an inner surface at least partially enclosing the delivery manifold and the absorbent layer; a first aperture formed proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifold from a reduced-pressure source; a second aperture formed proximate a second longitudinal end of the delivery-and-fluid-storage bridge for transmitting reduced pressure to a tissue site; and a conduit at the second longitudinal end of the delivery-and-fluid-storage bridge, the conduit being a lumen substantially isolated from fluid communication with the delivery manifold and the absorbent layer along the length of the delivery-and-fluid-storage bridge.
2. The delivery-and-fluid-storage bridge of claim 1, wherein the delivery manifold comprises a non-absorbent material and the absorbent layer comprises is a highly-absorbent material.
3. The delivery-and-fluid-storage bridge of claim 1, wherein the delivery manifold comprises a material with a plurality of flow channels that distribute fluids and the absorbent layer comprises at least one of the following: capillary-containing material, super absorbent fibers, hydrofibers, sodium carboxymethyl cellulose, alginate, and sodium polyacrylate.
4. The delivery-and-fluid-storage bridge of claim 1, further comprising an adhesive member proximate the second aperture.
5. The delivery-and-fluid-storage bridge of claim 1, wherein the absorbent layer comprises a capillary-containing material.
6. The delivery-and-fluid-storage bridge of claim 1, further comprising a hydrophobic filter proximate the first aperture for preventing fluids from exiting the delivery-and-fluid-storage bridge.
7. The delivery-and-fluid-storage bridge of claim 1, wherein the delivery-and-fluid-storage bridge has a reservoir portion with a plan view surface area A.sub.1 and a placement portion with a plan view surface area A.sub.2, and wherein A.sub.1>A.sub.2.
8. The delivery-and-fluid-storage bridge of claim 1, wherein the first encapsulating layer and the second encapsulating layer are formed from an integral piece of polyurethane.
9. A delivery-and-fluid-storage bridge for use with a reduced-pressure treatment system, the delivery-and-fluid-storage bridge comprising: a plurality of delivery manifolds extending along a length of the delivery-and-fluid-storage bridge for delivering reduced pressure to a tissue site; an absorbent layer adapted to receive and absorb fluids, wherein the absorbent layer has an outer surface and an interior portion; wherein the absorbent layer is disposed between at least two delivery manifolds of the plurality of delivery manifolds; an encapsulating pouch encapsulating the plurality of delivery manifolds and the absorbent layer, the encapsulating pouch comprising: a first encapsulating layer and a second encapsulating layer having an inner surface at least partially enclosing the plurality of delivery manifolds and the absorbent layer, the second encapsulating layer comprising a patient-facing side of the delivery-and-fluid-storage bridge, a first aperture formed on the first encapsulating layer proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifolds from a reduced-pressure source, and a second aperture formed on the patient-facing side of the second encapsulating layer for transmitting reduced pressure to the tissue site and a conduit disposed within the encapsulating pouch and extending substantially along the length of the delivery-and-fluid-storage bridge.
10. The delivery-and-fluid-storage bridge of claim 9, wherein the absorbent layer comprises a capillary-containing material.
11. The delivery-and-fluid-storage bridge of claim 9, wherein the plurality of delivery manifolds comprises a plurality of foam members.
12. The delivery-and-fluid-storage bridge of claim 9, further comprising a micro-pump coupled to the first longitudinal end of the delivery-and-fluid-storage bridge.
13. The delivery-and-fluid-storage bridge of claim 9, further comprising a micro-pump coupled to the first longitudinal end of the delivery-and-fluid-storage bridge, wherein the micro-pump comprises a piezoelectric pump.
14. The delivery-and-fluid-storage bridge of claim 9, further comprising a micro-pump and a remote battery, the micro-pump coupled to the first longitudinal end of the delivery-and-fluid-storage bridge, wherein the micro-pump comprises a piezoelectric pump, and wherein the remote battery is coupled to the piezoelectric pump.
15. The delivery-and-fluid-storage bridge of claim 9, further comprising a micro-pump fluidly coupled to the first longitudinal end of the delivery-and-fluid-storage bridge, wherein the micro-pump comprises a piezoelectric pump, and wherein a remote battery is coupled to and proximate to the piezoelectric pump.
16. The delivery-and-fluid-storage bridge of claim 9, further comprising a separation portion formed proximate the first longitudinal end inboard of the first aperture.
17. The delivery-and-fluid-storage bridge of claim 9, further comprising an adhesive member proximate the second aperture on the patient-facing side of the delivery-and-fluid-storage bridge.
18. The delivery-and-fluid-storage bridge of claim 9, further comprising a hydrophobic filter proximate the first aperture.
19. The delivery-and-fluid-storage bridge of claim 9, wherein the delivery-and-fluid-storage bridge has a reservoir portion with a plan view surface area A.sub.1 and a placement portion with a plan view surface area A.sub.2, and wherein A.sub.1>A.sub.2.
20. The delivery-and-fluid-storage bridge of claim 9, further comprising a wicking layer coupled to the patient-facing side of the second encapsulating layer.
21. The delivery-and-fluid-storage bridge of claim 9, further comprising an odor-control layer disposed within the encapsulating pouch.
22. The delivery-and-fluid-storage bridge of claim 9, wherein the conduit is substantially isolated from fluid communication with the plurality of delivery manifolds and the absorbent layer along the length of the delivery-and-fluid-storage bridge.
23. A method for treating a tissue site, the method comprising: providing a delivery-and-fluid-storage bridge, comprising: a delivery manifold extending along a length of the delivery-and-fluid-storage bridge, the delivery manifold comprising a first material, an absorbent layer proximate the delivery manifold adapted to receive and store fluids, the absorbent layer comprising a second material, wherein the absorbent layer has an outer surface and an interior portion, the delivery manifold has an outer surface and an interior portion, and the outer surface of the delivery manifold is configured to be adjacent to the outer surface of the absorbent layer, and an encapsulating pouch having an inner surface encapsulating the delivery manifold and the absorbent layer; placing a second longitudinal end of the delivery-and-fluid-storage bridge at the tissue site; applying a reduced pressure to a first longitudinal end of the delivery-and-fluid-storage bridge; communicating the reduced pressure through the delivery manifold to the tissue site through the second longitudinal end of the delivery-and-fluid-storage bridge; monitoring pressure proximate the tissue site through a conduit having an end positioned at the second longitudinal end of the delivery-and-fluid-storage bridge, the conduit disposed within the encapsulating pouch and being substantially isolated from fluid communication with the delivery manifold and the absorbent layer along the length of the delivery-and-fluid-storage bridge; and wicking liquids extracted from the tissue site through the second longitudinal end into the absorbent layer.
24. The method of claim 23, further comprising using an adhesive to fluidly seal the second longitudinal end of the delivery-and-fluid-storage bridge over the tissue site.
25. The method of claim 23, further comprising placing a treatment manifold proximate the tissue site; and placing a sealing member over the treatment manifold.
26. The method of claim 23, wherein applying a reduced pressure to the first longitudinal end comprises supplying reduced pressure from a reduced-pressure source to the first longitudinal end, and wherein there is no canister between the reduced-pressure source and the first longitudinal end.
27. The method of claim 23, wherein the absorbent layer comprises a capillary-containing material.
28. The method of claim 23, wherein the first material comprises a non-absorbent material and the second material comprises a highly-absorbent material.
29. The method of claim 23, wherein the first material comprises a material with a plurality of flow channels that distribute fluids and the second material comprises at least one of the following: capillary-containing material, super absorbent fibers, hydrofibers, sodium carboxymethyl cellulose, alginate, and sodium polyacrylate.
30. The method of claim 23, wherein wicking liquids extracted from the tissue site comprises wicking the liquids into the absorbent layer and storing substantially all the liquids received in the absorbent layer.
31. The method of claim 23, wherein wicking liquids extracted from the tissue site comprises wicking the liquids into the absorbent layer and storing substantially all the liquids received in the absorbent layer, and further comprising signaling when the absorbent layer is full.
32. A method of manufacturing a delivery-and-fluid-storage bridge, comprising: providing a delivery manifold; placing an absorbent layer proximate the delivery manifold, wherein the absorbent layer has an outer surface and an interior portion, the delivery manifold has an outer surface and an interior portion, and the outer surface of the delivery manifold is configured to be adjacent to the outer surface of the absorbent layer; encapsulating the delivery manifold and the absorbent layer in an encapsulating pouch, the encapsulating pouch comprising a first encapsulating layer and a second encapsulating layer having an inner surface at least partially enclosing the delivery manifold and the absorbent layer, the second encapsulating layer comprising a second, patient-facing side of the delivery-and-fluid-storage bridge; forming a first aperture proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifold from a reduced-pressure source; forming a second aperture on the second, patient-facing side of the second encapsulating layer for transmitting reduced pressure to a tissue site; and disposing a conduit within the encapsulating pouch, wherein the conduit extends along a length of the delivery-and-fluid-storage bridge.
33. The method of manufacturing of claim 32, wherein the absorbent layer comprises a capillary-containing material.
34. The method of manufacturing of claim 32, wherein the delivery manifold comprises a plurality of foam members.
35. The method of manufacturing of claim 32, further comprising coupling a micro-pump to the first longitudinal end of the delivery-and-fluid-storage bridge.
36. The method of manufacturing of claim 32, further comprising coupling a micro-pump to the first longitudinal end of the delivery-and-fluid-storage bridge, wherein the micro-pump comprises a piezoelectric pump.
37. The method of manufacturing of claim 32, further comprising coupling a micro-pump to the first longitudinal end of the delivery-and-fluid-storage bridge, wherein the micro-pump comprises a piezoelectric pump, the method further comprising coupling a remote battery to the piezoelectric pump.
38. The method of manufacturing of claim 32, further comprising forming a separation portion of the delivery-and-fluid-storage bridge proximate the first longitudinal end and inboard of the first aperture.
39. The method of manufacturing of claim 32, further comprising applying an adhesive member proximate the second aperture on the patient-facing side of the delivery-and-fluid-storage bridge.
40. The method of manufacturing of claim 32, further comprising placing a hydrophobic filter proximate the first aperture.
41. The method of manufacturing of claim 32, wherein the delivery-and-fluid-storage bridge has a reservoir portion with a plan view surface area A.sub.1 and a placement portion with a plan view surface area A.sub.2, and wherein A.sub.1>A.sub.2.
42. The method of manufacturing of claim 32, further comprising coupling a wicking layer to the second, patient-facing side of the second encapsulating layer.
43. The method of manufacturing of claim 32, further comprising disposing an odor-control layer within the encapsulated pouch.
44. The method of manufacturing of claim 32, wherein the conduit is substantially isolated from fluid communication with the delivery manifold and the absorbent layer along the length of the delivery-and-fluid-storage bridge.
45. The delivery-and-fluid-storage bridge of claim 1, wherein the conduit has an end positioned at the second longitudinal end of the delivery-and-fluid-storage bridge, and wherein the conduit extends substantially along the length of the delivery-and-fluid-storage bridge.
46. The delivery-and-fluid-storage bridge of claim 1, wherein the conduit is disposed between the first encapsulating layer and the second encapsulating layer and substantially isolated from fluid communication with the delivery manifold and the absorbent layer between the first longitudinal end and the second longitudinal end of the delivery-and-fluid-storage bridge.
47. The method of claim 23, further comprising determining a fluid saturation level within the delivery-and-fluid-storage bridge based upon a comparison of the reduced pressure applied to the first longitudinal end with a pressure monitored proximate the tissue site, wherein the pressure monitored proximate the tissue site is monitored at the second longitudinal end of the delivery-and-fluid-storage bridge.
48. The method of claim 23, further comprising determining a fluid saturation level within the delivery-and-fluid-storage bridge based upon a comparison of the reduced pressure applied to the first longitudinal end with a pressure monitored proximate the tissue site, wherein the pressure monitored proximate the tissue site is monitored at the tissue site.
49. The method of claim 23, further comprising comparing the reduced pressure applied to the first longitudinal end with a pressure monitored proximate the tissue site by the conduit.
50. A delivery-and-fluid-storage bridge, comprising: a delivery manifold extending along a length of the delivery-and-fluid-storage bridge; an encapsulating pouch having an inner surface enclosing the delivery manifold; a first aperture proximate a first longitudinal end of the delivery-and-fluid-storage bridge; a second aperture proximate a second longitudinal end of the delivery-and-fluid-storage bridge; and a conduit at the second longitudinal end of the delivery-and-fluid-storage bridge, the conduit being substantially isolated from fluid communication with the delivery manifold along the length of the delivery-and-fluid-storage bridge, wherein the conduit is configured to be disposed at or near a tissue site at the second longitudinal end of the delivery-and-fluid-storage bridge.
51. The delivery-and-fluid-storage bridge of claim 50, wherein the conduit extends substantially along the length of the delivery-and-fluid-storage bridge.
52. The delivery-and-fluid-storage bridge of claim 50, wherein the conduit is disposed within the encapsulating pouch.
53. The delivery-and-fluid-storage bridge of claim 50, wherein the delivery manifold comprises a porous material adapted to communicate fluid.
54. The delivery-and-fluid-storage bridge of claim 50, further comprising an absorbent layer proximate the delivery manifold adapted to receive and store fluids, wherein the encapsulating pouch is adapted to enclose the delivery manifold and the absorbent layer.
55. The delivery-and-fluid-storage bridge of claim 54, wherein the conduit is substantially isolated from fluid communication with the delivery manifold and the absorbent layer along the length of the delivery-and-fluid-storage bridge.
56. The delivery-and-fluid-storage bridge of claim 54, wherein the delivery manifold comprises a non-absorbent material and the absorbent layer comprises a highly-absorbent material.
57. The delivery-and-fluid-storage bridge of claim 50, wherein the encapsulating pouch comprises a first encapsulating layer and a second encapsulating layer enclosing the delivery manifold.
58. The delivery-and-fluid-storage bridge of claim 57, wherein the first aperture is formed on the first encapsulating layer.
59. The delivery-and-fluid-storage bridge of claim 57, wherein the second aperture is formed on a second, patient-facing side of the second encapsulating layer.
60. The delivery-and-fluid-storage bridge of claim 50, wherein the first aperture is proximate the delivery manifold.
61. The delivery-and-fluid-storage bridge of claim 50, wherein the conduit has an end disposed at the second longitudinal end of the delivery-and-fluid-storage bridge.
62. The delivery-and-fluid-storage bridge of claim 50, wherein the first aperture is adapted to be fluidly coupled to a reduced-pressure source and the second aperture is adapted to be fluidly coupled to a tissue site.
63. A delivery-and-fluid-storage bridge, comprising: a first manifold having an outer surface an interior portion extending along a length of the delivery-and-fluid-storage bridge; a second manifold having an outer surface and interior portion; an encapsulating pouch having an inner surface enclosing the first manifold and the second manifold; a first aperture proximate a first longitudinal end of the delivery-and-fluid-storage bridge; a second aperture proximate a second longitudinal end of the delivery-and-fluid-storage bridge; and a longitudinal sheet disposed within the encapsulating pouch between the first manifold and the second manifold.
64. The delivery-and-fluid-storage bridge of claim 63, wherein the encapsulating pouch comprises a first encapsulating layer and a second encapsulating layer, and wherein the longitudinal sheet is coupled to at least a portion of the first encapsulating layer and at least a portion of the second encapsulating layer.
65. The delivery-and-fluid-storage bridge of claim 63, wherein at least a portion of the inner surface of the encapsulating pouch and the longitudinal sheet define a conduit having a lumen.
66. The delivery-and-fluid-storage bridge of claim 65, wherein the second manifold is disposed within the lumen.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
(13) In the following detailed description of the illustrative embodiments, reference is made to the accompanying drawings that form a part hereof. 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 embodiments described herein, 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 illustrative embodiments are defined only by the appended claims.
(14) Referring primarily to
(15) The reduced-pressure treatment system 100 may be used with a tissue site at a non-limited-access site or a limited-access site. Other illustrative examples of limited-access tissue sites include on a patient's back, under a compression garment, in a total contact casting (TCC), in a removable walker, in a healing sandal, in a half shoe, or in an ankle foot orthoses. The reduced-pressure treatment system 100 may be used with the bodily tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue.
(16) The delivery-and-fluid-storage bridge 102 provides a low profile source of reduced pressure to be supplied to the tissue site 104 and thereby may increase patient comfort and enhance reliability of the reduced-pressure supply to the tissue site 104. Because of the low profile of the delivery-and-fluid-storage bridge 102, the delivery-and-fluid-storage bridge 102 may readily be used with an offloading device. The low profile of the delivery-and-fluid-storage bridge 102 allows the delivery-and-fluid-storage bridge 102 to be used in numerous situations without raising pressure at a particular location, which can lead to the formation of pressure ulcers. The delivery-and-fluid-storage bridge 102 may allow the patient the benefit of both reduced-pressure treatment as well as the offloading of physical pressure.
(17) With reference to
(18) The first longitudinal end 110 is typically placed at a location on or near the patient that provides convenient access by the healthcare provider, such as a convenient location for applying reduced-pressure to the reduced-pressure-interface site 114. If a reduced-pressure interface 116 is attached at the first longitudinal end 110 at the first aperture 152, any type of reduced-pressure source may be attached to the reduced-pressure interface 116. For example, a pump could be attached to the reduced-pressure interface 116 or a reduced-pressure delivery conduit 118 could be attached with a remote reduced-pressure source. When an offloading device, e.g., offloading boot 108, is utilized, the delivery-and-fluid-storage bridge 102 would extend from the tissue site 104 to a place outside of the offloading device. The actual longitudinal length (L) 132 (see
(19) A reduced-pressure delivery conduit 118 may fluidly couple the reduced-pressure interface 116 to a reduced-pressure source 120 or the reduced-pressure source 120 may be formed integrally with the delivery-and-fluid-storage bridge 102 as discussed further below. The reduced-pressure source 120 may be any device for supplying a reduced pressure, such as a vacuum pump, wall suction, or integrated micro-pump. While the amount and nature of reduced pressure applied to a tissue site will typically vary according to the application, the reduced pressure will typically be between 5 mm Hg (667 Pa) and 500 mm Hg (66.7 kPa) and more typically between 25 mm Hg (3.33 kPa) and 200 mm Hg (26.6 kPa). For example, and not by way of limitation, the pressure may be 12, 12.5, 13, 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25, 25.5, 26, 26.5 kPa or another pressure. For vertical applications of the delivery-and-fluid-storage bridge 102, such as is shown in
(20) As used herein, reduced pressure 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 at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. Although the terms vacuum and negative pressure may be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site may be more than the pressure normally associated with a complete vacuum. Consistent with the use herein, an increase in reduced pressure or vacuum pressure typically refers to a relative reduction in absolute pressure. In one illustrative embodiment, a V.A.C. Therapy Unit by Kinetic Concepts, Inc. of San Antonio may be used as the reduced-pressure source 120.
(21) If the reduced-pressure interface 116 is attached at the first longitudinal end 110 at the first aperture 152, any type of reduced-pressure source 120 may be attached to the reduced-pressure interface 116. For example, a pump, such as micro-pump 128, could be attached to the reduced-pressure interface 116 or a reduced-pressure delivery conduit 118 could be attached with a remote reduced-pressure source.
(22) Depending on the application, a plurality of devices may be fluidly coupled to the reduced-pressure delivery conduit 118. For example, a fluid canister 122 or a representative device 124 may be included. The representative device 124 may be another fluid reservoir or canister to hold exudates and other fluids removed. Other examples of the representative device 124 that may be included on the reduced-pressure delivery conduit 118 include the following non-limiting examples: a pressure-feedback device, a volume detection system, a blood detection system, an infection detection system, a flow monitoring system, a temperature monitoring system, a filter, etc. Some of these devices may be formed integrally with the reduced-pressure source 120. For example, a reduced-pressure port 126 on the reduced-pressure source 120 may include a filter member that includes one or more filters, e.g., an odor filter.
(23) Referring now primarily to
(24) The delivery-and-fluid-storage bridge 102 has an encapsulating pouch 136 that encapsulates fully or partially at least a first delivery manifold 138 and at least one absorbent layer 140 as shown in
(25) The delivery manifolds 138, 142, 144 and the treatment manifold 109 may be formed from any manifold material for distributing reduced pressure. 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 location, such as a tissue site. The manifold material typically includes a plurality of flow channels or pathways that distribute fluids provided to and removed from locations around the manifold material. In one illustrative embodiment, the flow channels or pathways are interconnected to improve distribution of fluids. Examples of manifold materials may include, without limitation, devices that have structural elements arranged to form flow channels, such as, for example, cellular foam, open-cell foam, porous tissue collections, liquids, gels, non-wovens, and foams that include, or cure to include, flow channels. The manifold material may be porous and may be made from foam, gauze, felted mat, or any other material suited to transport fluids. In one embodiment, the manifold material is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam material manufactured by Kinetic Concepts, Incorporated of San Antonio, Tex. Other embodiments may include closed cells at least on portions.
(26) The delivery manifolds 138, 142, 144 may be formed from a manifold material that may be a high-wicking manifold material, such as a capillary material or non-woven material. The high-wicking material used for the delivery manifold material may allow the delivery-and-fluid-storage bridge 102 to operate removing the fluid through the delivery-and-fluid-storage bridge 102 even without reduced pressure being applied.
(27) The absorbent layer 140 may be formed from any material that is adapted to receive and store fluids. For example, without limitation, the absorbent layer 140 may be formed from one or more of the following: capillary-containing material, super absorbent fiber/particulates, hydrofiber, sodium carboxymethyl cellulose, alginates, sodium polyacrylate, or other suitable material. The absorbent layer 140 and the manifold material used for the delivery manifolds 138, 142, 144 may in some illustrative embodiments be treated with a plasma coating to increase the hydrophilic properties and to thereby aid in fluid transfer through the system. The hydrophilic properties of the manifolds 138, 142, 144 may also be enhanced by coating the manifolds 138, 142, 144 with a dip or spray of a suitable material such as a HYDAK coating. Use of the absorbent layer 140 as an aspect of the reduced-pressure treatment system 100 allows the fluids removed to be stored locally, i.e., fairly close to the tissue site 104, such that the removed fluids are not transported a great distance.
(28) The encapsulating pouch 136 typically is formed with a first encapsulating layer 148 and a second encapsulating layer 150 that at least partially enclose the delivery manifold(s) 138, 142, 144 and absorbent layer 140. The second encapsulating layer 150 is the second, patient-facing side 105 of the delivery-and-fluid-storage bridge 102. The first aperture 152 is formed proximate the first longitudinal end 110 of the delivery-and-fluid-storage bridge 102 on the first encapsulating layer 148. The first aperture 152 is for fluidly communicating reduced pressure to the delivery manifold(s) 138, 142, 144 from the reduced-pressure source 120. A second aperture 154 is formed on the second, patient-facing side 105 of the second encapsulating layer 150 for transmitting reduced pressure from the interior portion 146 to the tissue site 104. An anti-microbial additive may be included in the interior portion 146 to help control bacteria growth.
(29) The first encapsulating layer 148 and the second encapsulating layer 150 have peripheral edges 156 that may be coupled to form the encapsulating pouch 136. The peripheral edges 156 may be coupled using any technique. As used herein, the term coupled includes coupling via a separate object and includes direct coupling. The term coupled also encompasses two or more components that are continuous with one another by virtue of each of the components being formed from the same piece of material. The term coupled may include chemical, such as via a chemical bond, adhesive, mechanical, or thermal coupling. Coupling may include without limitation welding (e.g., ultrasonic or RF welding), bonding, adhesives, cements, etc. Fluid coupling means that fluid is in communication between the designated parts or locations. Thus, the first encapsulating layer 148 and the second encapsulating layer 150 may be coupled among other ways by weld 158.
(30) The encapsulating layers 148, 150 may be formed from any material that provides a fluid seal about the interior portion 146 that allows a reduced-pressure to be maintained therein for a given reduced-pressure source. The encapsulating layers 148, 150 may, for example, be an impermeable or semi-permeable, elastomeric material. For semi-permeable materials, the permeability must be low enough that for a given reduced-pressure source, the desired reduced pressure may be maintained. Elastomeric means having the properties of an elastomer. Elastomeric material generally refers to a polymeric material that has rubber-like properties. More specifically, most elastomers have ultimate elongations 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 (PU), EVA film, co-polyester, and silicones. Additional, specific examples of sealing member materials include a silicone drape, a 3M Tegaderm drape, or a polyurethane (PU) drape such as one available from Avery Dennison Corporation of Pasadena, Calif.
(31) As shown in
(32) An adhesive member or members 161, e.g., adhesive ring 163, may be applied to the second, patient-facing side 105 of the delivery-and-fluid-storage bridge 102 proximate the second aperture 154. The adhesive member(s) 161 helps form a fluid seal proximate the tissue site 104either on a sealing member (see, e.g., 315 in
(33) Additional items may disposed in the interior portion 146 at discrete locations or along the longitudinal length 132 of the delivery-and-fluid-storage bridge 102. For example, as shown in
(34) A color change dye may be included at the first longitudinal end 110 of the delivery-and-fluid-storage bridge 102 in order to provide feedback on the status of the absorbent layer 140. The color change dye may change colors or tone when the color change dye becomes wet thereby providing a visual indication that the delivery-and-fluid-storage bridge 102 is full. Moreover, color change dye may be positioned at various locations or continually along the delivery-and-fluid-storage bridge 102 to provide a progressive indications of capacity used, e.g., 25%, 50%, 75%, 100% used. Electrodes in the delivery-and-fluid-storage bridge 102 may be included at the first longitudinal end to form a galvanic cell that provides a voltage when the electrodes are covered by exudate or other removed liquids. In addition, the lumen 164 could monitor pressure at the second longitudinal end 112 and this information could be compared with pressure at the reduced-pressure source 120 to determine the pressure drop across the system 100 and thereby the saturation determined.
(35) In another embodiment, the lumen 164 may be formed using a portion of the first encapsulating layer 148 or second encapsulating layer 150 and an additional longitudinal sheet secured to an inward-facing surface of the first encapsulating layer 148 or second encapsulating layer 150 to form the lumen 164. In still another embodiment, the lumen 164 may have a manifolding material disposed within the lumen 164. In still another embodiment, a longitudinal manifold material may be placed between the first encapsulating layer 148 and second encapsulating layer 150 near a periphery where the first encapsulating layer 148 and second encapsulating layer 150 otherwise directly touch. A seal or bond may be formed on each side of the longitudinal manifold material to form the lumen 164 with the manifold material therein.
(36) In operation, the treatment manifold 109 may be placed into or proximate the tissue site 104. A sealing member (see, e.g., sealing member 315 in
(37) The longitudinal length 132 of the delivery-and-fluid-storage bridge 102 may be used to position the first longitudinal end 110 at a convenient location to either attach the reduced-pressure interface 116 and reduced-pressure delivery conduit 118 as shown in
(38) As the reduced-pressure source 120 is activated, the reduced-pressure source 120 communicates the reduced pressure along the delivery-and-fluid-storage bridge 102 through the delivery manifold(s) 138, 142, 144 to the second longitudinal end 112 of the delivery-and-fluid-storage bridge 102. The reduced pressure is then applied through the second aperture 154 to the treatment manifold 109 proximate the tissue site 104. In addition, typically, fluids are extracted from the tissue site 104 and received through the second aperture 154. After entering the interior portion 146, the fluids are recruited into the absorbent layer 140 positioned proximate the delivery manifold(s) 138, 142, 144. The fluids are substantially recruited and maintained in the absorbent layer 140. As a result, typically reduced pressure may be transported relatively more efficiently through the delivery manifold(s) 138, 142, 144. In this way, the reduced pressure need not overcome gravity's influence on a column of liquid to the same degree as the reduced pressure otherwise would. Typically, the pressure drop realized over the delivery-and-fluid-storage bridge 102 is constant until the absorbent layer 140 becomes saturated. As previously noted, a high-wicking material may be used for the delivery manifold material in order to allow the delivery-and-fluid-storage bridge 102 to remove the fluid through the delivery-and-fluid-storage bridge 102 even without reduced pressure being applied.
(39) Thus, the delivery-and-fluid-storage bridge 102 may be particularly useful in avoiding a situation in which excessive fluid from a tissue site is held against gravity by reduced pressure alone. The delivery-and-fluid-storage bridge 102 moves liquids into storage and provides a flow path for gases. The liquids are drawn into the absorbent layer 140 and the gases are allowed to remain in the delivery manifolds 138, 142, 144. By using this approach, the reduced-pressure source 120 does not have to be modulated as the amount of fluid in the delivery-and-fluid-storage bridge 102 increases. Typically, the pressure drop realized over the delivery-and-fluid-storage bridge 102 is constant until the absorbent layer 140 becomes saturated.
(40) Referring now primarily to
(41) The delivery-and-fluid-storage bridge 202 further includes a reservoir portion 207 and a placement portion 211. The reservoir portion 207 has a first aspect ratio (length/width) AR.sub.1 and the placement portion 211 has a second aspect ratio AR.sub.2. The placement portion has a higher aspect ration to facilitate placement of the second longitudinal end 212 and the reservoir portion 207 has a lower aspect ratio (AR.sub.2>AR.sub.1). Stated in other terms, the area (A.sub.1) in plan view of the reservoir portion 207 is greater than the area (A.sub.2) in plan view of the placement portion 211, i.e., A.sub.1>A.sub.2. The placement portion 211 facilitates easy placement and positioning of the second longitudinal end 212 in limited-access tissue sites and the reservoir portion 207 provides increased space for fluids to be stored.
(42) While the reservoir portion 207 and the placement portion 211 are shown with a specific shape, it should be understood that numerous shapes may be given to the delivery-and-fluid-storage bridge 202. For example, in another illustrative embodiment, the delivery- and storage bridge 202 is shaped like a triangle with the apex being the second longitudinal end. In another illustrative embodiment, the deliver-and-storage bridge 202 may have a shape that resembles a lollipopa thinner section coming away from the first longitudinal end with a larger portion at the first longitudinal end.
(43) Referring now primarily to
(44) The treatment manifold 309 is placed proximate the tissue site 304 and then a fluid seal is formed over the treatment manifold 309 by using a sealing member 315. An adhesive device 317 may be used to help form a fluid seal between the sealing member 315 and the patient's skin 319. The sealing member 315 may have a treatment aperture 321 for providing access to the treatment manifold 309. Thus, the reduced pressure is delivered through a second aperture 354 and through the treatment aperture 321 to the treatment manifold 309.
(45) The delivery-and-fluid-storage bridge 302 has an encapsulation pouch 336 formed with a first encapsulation layer 348 and a second encapsulation layer 350. The encapsulation pouch 336 has disposed within an interior portion a plurality of delivery manifolds 342 and an absorbent layer 340.
(46) A first aperture (not explicitly shown) is formed on the first longitudinal end 310. A reduced-pressure source 320 provides reduced pressure through the first aperture to the interior of the encapsulation pouch 336. From there, the reduced pressure is delivered to the second longitudinal end 312 as previously discussed. In this illustrative, non-limiting example, the reduced-pressure source 320 is a micro-pump 328, which has a piezoelectric pump 330 and a battery, such as battery 331, that are integrated with the delivery-and-fluid-storage bridge 302. In the illustrative embodiment of
(47) As shown in
(48) In the illustrative embodiment of
(49) The low profile of the delivery-and-fluid-storage bridges 102, 202, 302 herein allows for each bridge 102, 202, 302 to be used in numerous situations without raising pressure at a particular point, i.e., without causing a stress riser, which can lead to the formation of pressure ulcers. The delivery-and-fluid-storage bridge 102, 202, 302 separates liquids from gases. The liquids are drawn into the absorbent layer, e.g., absorbent layer 140, until saturation occurs and the gases are allowed to remain in the delivery manifolds 142 or manifold 138 from where the gases may be removed by a reduced pressure source.
(50) 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 connection to any one embodiment may also be applicable to any other embodiment.
(51) It will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments. It will further be understood that reference to an item refers to one or more of those items.
(52) The steps of the methods described herein may be carried out in any suitable order, or simultaneously where appropriate.
(53) Where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems.
(54) It will be understood that the above description of preferred embodiments is given by way of example only and that various modifications may be made by those skilled in the art. The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the invention. Although various embodiments of the invention have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of the claims.