SYSTEMS AND METHODS FOR IMPROVED CONNECTION TO WOUND DRESSINGS IN CONJUNCTION WITH REDUCED PRESSURE WOUND TREATMENT SYSTEMS
20220023525 · 2022-01-27
Inventors
- Keith Patrick Heaton (Poole, GB)
- Timothy Mark Robinson (Shillingstone, GB)
- Christopher Brian Locke (Bournemouth, GB)
Cpc classification
A61M1/73
HUMAN NECESSITIES
A61M1/915
HUMAN NECESSITIES
A61M2205/3344
HUMAN NECESSITIES
A61M1/966
HUMAN NECESSITIES
A61M1/743
HUMAN NECESSITIES
International classification
Abstract
A system for applying reduced pressure to tissue includes a multi-lumen reduced pressure delivery tube having a proximate end, a distal end, a primary lumen extending through the conduit from the proximate end to the distal end, and an ancillary lumen extending through the conduit from the proximate end to the distal end. A vacuum pump is coupled to the proximate end of the primary lumen, and a reduced pressure adapter is coupled to the distal end of the reduced pressure delivery tube. The adapter includes channels to direct liquid away from the ancillary lumens and into the primary lumen.
Claims
1. An adapter for reduced-pressure treatment, the adapter comprising: a base; a perimeter ring attached to the base; a first bearing ring within the perimeter ring; a sealing ring within the first bearing ring; a second bearing ring within the sealing ring; and a housing coupled to the perimeter ring and rotatable around the second bearing ring.
2. The adapter of claim 1, wherein the housing comprises: a primary conduit through the housing; and a measurement conduit through the housing.
3. The adapter of claim 1, wherein the housing comprises: a primary conduit through the housing; a measurement conduit through the housing; an entry surface; and channels on the entry surface to preferentially route fluids into the primary conduit.
4. The adapter of claim 1, wherein the housing includes a recessed region defining an entry surface.
5. The adapter of claim 4, further comprising: a primary conduit through the housing in fluid communication with a primary port on the entry surface; at least one ancillary conduit in fluid communication with an ancillary port on the entry surface; and channels positioned on the entry surface to direct fluids away from the ancillary port and to the primary port.
6. The adapter of claim 5, wherein the channels comprise linear channels configured to direct fluids into the primary conduit.
7. The adapter of claim 5, wherein: the channels comprise a linear channel section configured to direct fluids into the primary conduit; and the linear channel section is located in approximately half of the recessed region.
8. The adapter of claim 5, wherein the channels comprise radial channels configured to direct fluids into the primary conduit.
9. The adapter of claim 5, wherein the base further comprises one or more of: radial channels positioned on the base to direct fluids from a periphery of the base away from the ancillary conduit; an intermediate collection channel positioned on the base to direct fluids into the radial channels on the base; and a perimeter collection channel positioned on the base to direct fluids into the radial channels on the base.
10. The adapter of claim 5, wherein: the channels comprise a radial channel section configured to direct fluids into the primary conduit; and the radial channel section is located in approximately a third of the recessed region.
11. The adapter of claim 5, wherein the channels comprise linear channels and radial channels configured to direct fluids into the primary conduit.
12. The adapter of claim 5, further comprising: a wall section supporting and surrounding the ancillary conduit, the wall section having a first surface, a second surface, and guide channels along the second surface extending from proximate the ancillary port toward the primary port.
13. The adapter of claim 4, further comprising a volatile organic compound sensitive strip mounted within the recessed region.
14. The adapter of claim 13, wherein a color pattern is adapted to appear on the volatile organic compound sensitive strip when the volatile organic compound sensitive strip is exposed to one or more microorganisms.
15. The adapter of claim 13, wherein the volatile organic compound sensitive strip can be visually inspected through the housing.
16. A multi-lumen reduced-pressure delivery apparatus having a first end and a second end, comprising: a primary conduit extending from the first end to the second end; and an ancillary conduit extending from the first end to the second end adjacent to the primary conduit; wherein the primary conduit has a first cross-section and the ancillary conduit has a second cross-section substantially smaller than the first cross-section.
17. A system for providing reduced pressure to a tissue site, the system comprising: a delivery lumen fluidly coupled to the tissue site; a reduced-pressure source fluidly coupled to the delivery lumen; a first measurement lumen fluidly coupled to the tissue site; a first pressure sensor fluidly coupled to the first measurement lumen; a first valve fluidly coupled to the first measurement lumen; a second measurement lumen fluidly coupled to the tissue site; a second pressure sensor fluidly coupled to the second measurement lumen; a second valve fluidly coupled to the second measurement lumen; and a controller coupled to the reduced-pressure source, the first pressure sensor, the first valve, the second pressure sensor, and the second valve, the controller configured to: receive data from the first pressure sensor and the second pressure sensor indicative of pressure at the tissue site, compare data from the first pressure sensor and the second pressure sensor, open the first valve if a response time of the first pressure sensor is greater than a response time of the second pressure sensor, and operate the reduced-pressure source based on the data from the second pressure sensor if the response time of the first pressure sensor is greater than the response time of the second pressure sensor.
18. The system of claim 1, wherein the delivery lumen, the first measurement lumen, and the second measurement lumen are disposed within a single multi-lumen reduced-pressure delivery apparatus.
19. The system of claim 2, wherein the delivery lumen has a cross-sectional dimension that is larger than a cross-sectional dimension of the first measurement lumen and a cross-sectional dimension of the second measurement lumen.
20. The system of claim 1, further comprising: a distribution manifold fluidly coupled to the delivery lumen, the first measurement lumen, and the second measurement lumen; and a drape comprising an adhesive surface adapted for securing the distribution manifold to the tissue site.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Although the scope of the present invention is much broader than any particular embodiment, a detailed description of the preferred embodiment follows, together with illustrative figures, wherein like reference numerals refer to like components, and wherein:
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0040] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific preferred embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims.
Reduced Pressure Adapter
[0041] Improvements in an RPWT system are disclosed that provide a reduced pressure adapter to improve the reliability of operation and prevent or reduce instances of unintentional liquid ingress into the measurement lumens of a reduced pressure delivery tube, particularly in conjunction with a low-profile dressing. Traditional adapters typically include both a sensing lumen and a reduced pressure delivery lumen together an elbow-shaped housing. A common cause of failure for these reduced pressure adapters results from liquid ingress into the sensing lumen, which may cause the control of therapy to become unstable and, in extreme cases, may contribute to the eventual shutdown of the device. Part of this problem is due to the location of the fluid conduction and the nature of wound fluid in general. Wound excretions and fluids are generally pseudoplastic in consistency and will splash and foam in the elbow of a reduced pressure apparatus under the influence of reduced pressure. One goal of certain exemplary embodiments of the present invention, therefore, is to prevent the wound liquids and other non-gaseous fluids from entering the sensing lumen.
[0042] One concept of the improved reduced pressure adapter is for the lumens to be separate down to the distribution manifold of the wound dressing so that the distribution manifold becomes the barrier between the sensing lumens and the reduced pressure path. The underside of the reduced pressure adapter is provided with channel features that attract small droplets splashed inside the reduced pressure adapter during periods of high flow or after a large slug of liquid has been pulled into the tubing. This preferencing of the liquid and solid matter into the larger primary lumen, and away from the smaller ancillary measurement lumens, helps prevent the lumens from becoming blocked. The concept further includes providing offset outer measurement lumen ports in the pad, which are designed such that in most orientations one of the two should be above the flow level in the distribution manifold of the dressing. The reduced pressure adapter is further intended to operate in conjunction with the dynamic pressure control methodologies described in more detail below. The reduced pressure adapter may also include an adhesive drape or cover that secures the reduced pressure adapter within the wound. The profile of the reduced pressure adapter is low for increased patient comfort, and the reduced pressure adapter is preferably elbow-shaped such that the connecting tubing is routed cleanly away from the tissue site.
[0043] Reference is made first to
[0044] Wound dressing 12 is generally comprised of a distribution manifold 24 such as a porous pad or granular foam and a cover or drape 26 that secures the distribution manifold at a tissue site. Dressing 12 also may include improved reduced pressure adapter 22, as shown positioned on distribution manifold 24 and adhered thereto by an adhesive positioned on the reduced pressure adapter 22, the wound drape 26, or a separate adhesive drape associated with reduced pressure adapter 22.
[0045] Reduced pressure delivery tube 14 is a multi-lumen tube, comprised of one or more tubing sections 28 which, as an assembled structure, provide a continuous conduit between reduced pressure adapter 22 and container connector 34 positioned on fluid container 18. As described in more detail below, and as known in the art, liquid and other exudates drawn by RPWT system 10 are removed from the tubing at this point and are retained within container 18. Sections of additional tubing in the form of instrumentation tubing 36a and 36b likewise extend from container connector 34 to instrumentation components 20. In certain embodiments of the present invention, instrumentation components 20 comprise a reduced pressure source 38 and pressure monitoring instrument components 40a and 40b. Described in more detail below, each of these three instrument components 20 is individually associated with one of three isolated conduits (tubes or lumens) that extend from reduced pressure adapter 22 into remote fluid containment and instrumentation 16.
[0046] Reference is now made to
[0047] Reduced pressure adapter 22 generally comprises a base 50, which may be adhered to the distribution manifold, and a conduit housing 62 coupled to the base 50. Conduit housing 62 includes a primary conduit and a pair of ancillary conduits. The base 50 includes an aperture 53, which is positioned over the distribution manifold and through which the liquids and gases (collectively referred to as “fluids”) are drawn from the tissue site. A significant feature of improved reduced pressure adapter 22 is the presence of channel elements positioned near and in fluid communication with aperture 53 and the effective way in which the channel elements direct liquid into the primary conduit for drainage. The routing of liquids into the primary conduit maintains the ancillary conduits of the system open for pressure measurement purposes.
[0048] Referring to
[0049] A second end of the primary conduit terminates at a primary lumen interface 64. Primary lumen interface 64 is generally centrally positioned within aperture 66. Ancillary lumen interfaces 48, 49 (see
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[0053] Internal to conduit housing 62 are primary lumen interface 64 and ancillary lumen interfaces 48 and 49. Ancillary lumen interfaces 48 and 49 align with the corresponding lumens in the delivery tubing by placing the primary lumen in the tubing over the primary lumen interface 64. The structure of one embodiment of multi-lumen tubing used in conjunction with the improved reduced pressure adapter structure of the present invention is described in more detail below.
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[0057] Reference is now made to
[0058] Four basic features within the structure shown in
[0059] The remaining three features that direct liquids into the primary port are structural serrated channels formed on various portions of the entry surface 55 of recessed region 54. A first linear serrated channel section 42 is positioned in association with the approximately half circle section of recessed region 54 that is associated with ancillary port 58. The material that comprises the ceiling of this section of recessed region 54 covers and contains the conduit that extends between ancillary port 58 and its interface (not shown). This ceiling or wall is configured with an array of serrated channels or striations that directs liquids that fall upon this surface towards the primary port at the center of the recessed region 54. Any liquids that are drawn into the opening and fall upon this portion of the entry surface 55 would be channeled directly into primary port 60, rather than being directed into ancillary port 58.
[0060] A similar configuration is constructed in an approximately one-third circular radial serrated channel section 44. Insofar as no internal conduit is contained within this section of the recessed region 54, the serrated channels in section 44 may extend deeper and more directly to the primary port 60. These radial serrated channels are directed from the perimeter of aperture 54 towards the apex of the recessed region 54 that drains into primary port 60. These radial striations or channels extend from a radius adjacent ancillary port 58 radially around approximately one-third of the circle to a radius adjacent ancillary port 56. Any liquids that fall upon this portion of the recessed region 54 will be directed centrally to primary port 60, rather than being conducted to either of the ancillary ports.
[0061] Finally, the wall section that supports ancillary port 56 at the point at which the ancillary port 56 overhangs primary port 60 is structured with serrated or striated channels 46 that extend downward (upward in the normal positioning of the connector) from the opening of ancillary port 56 towards the opening of primary port 60.
[0062] As described above, the various internal features and elements of the recessed region 54 are structured to draw liquid from most points within the recessed region 54 towards the centrally located primary port 60. Only liquid that enters directly into ancillary port 56 or 58 would likely be drawing into an ancillary lumen. Insofar as little or no suction is occurring at these ports, this structure greatly reduces the likelihood of obstructions in the form of liquid or material blockages in an ancillary lumen.
Reduced Pressure Delivery Tube
[0063] Reference is now made to
Dynamic Method of Measuring Wound Pressure
[0064] The system of the present invention also includes an improved and dynamic method of measuring the wound pressure that overcomes problems inherent with current reduced pressure wound treatment control systems. Various methods have been developed in the art to control the operation of reduced pressure wound treatment products and systems to insure that the wound pressure is maintained and that the therapy is safe by effective operation of the prescribed regimens. Currently, wound pressure is measured with the outer lumen or lumens of a multi-lumen tube that are commoned together and connected to one pressure sensor. This structure can suffer certain problems if liquid enters the lumens or they become blocked. If such liquid intrusion or blockages occur, the system can become unstable and alarms or indicators related to pressure become unreliable. Various mechanical remedies for these problems have been attempted and some have been partially successful. Ultimately, however, a system such as described in the prior art will be challenged with liquid in the control lumen unless there is a physical barrier placed against the ingress of liquid into the measurement lumen(s). One goal of the present invention is a system that is more reliable and more robust when challenged with extremes of therapy, as compared to current single sensor measurement lumen systems.
[0065] Reference is made to
Reduced Pressure Adapter with Rotating Function
[0066] Currently, reduced pressure adapters in RPWT systems typically allow for the effective connection of reduced pressure wound therapy to the wound, but do not allow for the tube connection point to be repositioned (for example, in the event that the patient is susceptible to skin breakdown) or for a situation where the user has incorrectly positioned the reduced pressure adapter (for example, in the event that the reduced pressure adapter is facing in the wrong direction). In such instances, the user must remove and discard the reduced pressure adapter, and in some instances the drape, which causes discomfort and is a nuisance to the patient and user as well as an additional cost. Providing a rotation or swivel function to the reduced pressure adapter enables repositioning the tube without having to remove and relocate the reduced pressure adapter. This ability assists in any situation where the tubing requires relocation to avoid tissue damage. One goal of the present invention is to provide a reduced pressure adapter structure that allows for easy relocation of the tubing without removing and relocating the reduced pressure adapter or the wound dressing.
[0067] Reference is made to
[0068] The internal features and elements associated with the reduced pressure adapter as described above in conjunction with a non-rotating embodiment are equally applicable here and may be integrated into the inside structure of top rotating PVC component 112 by direct molding of the component or by positioning a molded insert into a shell to for rotating component 112. In any event, the same benefits of the liquid preferencing structures surrounding the lumen ports described above are obtainable with the rotating functionality of the alternate embodiment described.
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Reduced Pressure Adapter with Microorganism Indication
[0070] Current reduced pressure treatment systems do not generally alert the caregiver to the presence of microorganisms in wound dressings. Many of these microorganisms can be significant factors in controlling infection at the wound site. One goal of the present invention is to provide a system that will alert the caregiver to significant levels of key microorganisms under the classification of aerobic, non-aerobic, gram positive and gram negative. The response or indication is in the form of color patterns discretely reflecting the four classifications mentioned above.
[0071] A volatile organic compound (VOC) sensitive strip mounted on the reduced pressure adapter or its associated drape is utilized in certain embodiments. When exposed to the targeted VOC known to form in the presence of certain microorganisms, a color pattern becomes apparent and thereby identifies the type of microorganism present in the wound fluid. Referencing
[0072] It should be apparent from the foregoing that an invention having significant advantages has been provided. While the invention is shown in only a few of its forms, it is not just limited but is susceptible to various changes and modifications without departing from the spirit thereof.