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Title:
TUBE-SET FOR PRESSURE MONITORING
Document Type and Number:
WIPO Patent Application WO/2021/209951
Kind Code:
A1
Abstract:
An apparatus for providing instillation and negative pressure therapy to a tissue site may include a first port having a first fluid path and a second fluid path, a second port having a third fluid path, a third port having a fourth fluid path and a fifth fluid path, and a fourth port having have a sixth fluid path. The second fluid path can be independent from the first fluid path and the fifth fluid path can be independent from the fourth fluid path. The apparatus may fluidly couple the first fluid path and the fourth fluid path, the second fluid path and the sixth fluid path, and the third fluid path and the fifth fluid path. The first port and the third port may each be configured to receive a multi-lumen conduit. The second port and the fourth port may each be configured to receive a single lumen conduit.

Inventors:
PRATT BENJAMIN ANDREW (US)
SEDDON JAMES KILLINGWORTH (US)
EDWARDS THOMAS ALAN (US)
Application Number:
PCT/IB2021/053125
Publication Date:
October 21, 2021
Filing Date:
April 15, 2021
Export Citation:
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Assignee:
KCI LICENSING INC (US)
International Classes:
A61M1/00; A61M39/10; F16L37/56; F16L39/02
Foreign References:
US20200054804A12020-02-20
EP3260144A12017-12-27
EP3536246A12019-09-11
US20200086017A12020-03-19
Attorney, Agent or Firm:
ADAMSON, Trisha D., et al. (US)
Download PDF:
Claims:
CLAIMS

What is claimed is:

1. An apparatus for connecting multi-lumen conduits, the apparatus comprising: a first port having a first fluid path and a second fluid path, the second fluid path being independent of the first fluid path; a second port having a third fluid path; a third port having a fourth fluid path and a fifth fluid path, the fifth fluid path being independent of the fourth fluid path, a fourth port having a sixth fluid path; the first fluid path being fluidly coupled to the fourth fluid path; the second fluid path being fluidly coupled to the sixth fluid path; and the third fluid path being fluidly coupled to the fifth fluid path.

2. The apparatus of claim 1, wherein: the first port is configured to receive a multi-lumen tube; at least one lumen of the multi-lumen tube is fluidly coupled to the first fluid path; and at least one other lumen of the multi-lumen tube is fluidly coupled to the second fluid path.

3. The apparatus of claim 2, wherein the second port is configured to receive a single-lumen tube, the lumen of the single-lumen tube is fluidly coupled to the third fluid path.

4. The apparatus of claim 3, wherein: the multi-lumen tube is a first multi-lumen tube; the third port is configured to receive a second multi-lumen tube; at least one lumen of the second multi-lumen tube is fluidly coupled to the fourth fluid path; and at least one other lumen of the second multi-lumen tube is fluidly coupled to the fifth fluid path.

5. The apparatus of claim 4, wherein: the single-lumen tube is a first single-lumen tube; and the fourth port is configured to receive a second single lumen tube, the lumen of the second single lumen tube is fluidly coupled to the sixth fluid path.

6. The apparatus of claim 1, wherein the first port is configured to receive a multi-lumen tube.

7. The apparatus of claim 1, wherein the second port is configured to receive a single-lumen tube.

8. The apparatus of claim 1, wherein the third port is configured to receive a multi-lumen tube.

9. The apparatus of claim 1, wherein the fourth port is configured to receive a single-lumen tube.

10. A connector for inline fluid coupling of fluid paths of multi-lumen conduits, the connector comprising: a first housing comprising: a first receptacle having a first delivery conduit and a first sensing conduit, and a second receptacle; a second housing coupled to the first housing, the second housing comprising; a third receptacle having a second delivery conduit and a second sensing conduit, and a fourth receptacle; and the first sensing conduit being fluidly coupled to the second sensing conduit between the first housing and the second housing.

11. The connector of claim 10, wherein the first housing further comprises: a base comprising: a first planar surface; a second planar surface opposite the first planar surface; a first end; a second end opposite the first end; a first hole extending through the base from the first planar surface to the second planar surface, the first hole proximate to the first end; a second hole extending through the base from the first planar surface to the second planar surface, the second hole proximate to the second end; a first annular wall extending from the first planar surface and substantially surrounding the first hole, the first annular wall having an inner diameter coincident with a diameter of the first hole; a second annular wall extending from the first planar surface and substantially surrounding the second hole, the second annular wall having an inner diameter coincident with a diameter of the second hole; a third annular wall disposed in the first hole and coupled to the base, the third annular wall extending from the first planar surface and the second planar surface, the third annular wall having an outer diameter less than the inner diameter of the first annular wall to form the first sensing conduit between the first annular wall and the third annular wall, and the first delivery conduit inboard of the third annular wall; and a fourth annular wall coupled to the second planar surface inboard of an exterior edge of the base.

12. The connector of claim 11, wherein the second housing further comprises: a second base comprising: a third planar surface; a fourth planar surface opposite the third planar surface; a third end; a fourth end opposite the third end; a third hole extending through the second base from the third planar surface to the fourth planar surface, the third hole proximate to the third end; a fourth hole extending through the second base from the third planar surface to the fourth planar surface, the fourth hole proximate to the fourth end; a fifth annular wall extending from the third planar surface and substantially surrounding the third hole, the fifth annular wall having an inner diameter coincident with a diameter of the third hole; a sixth annular wall extending from the third planar surface and substantially surrounding the fourth hole, the sixth annular wall having an inner diameter coincident with a diameter of the fourth hole; a seventh annular wall disposed in the fourth hole and coupled to the second base, the seventh annular wall extending from the third planar surface and the fourth planar surface, the seventh annular wall having an outer diameter less than the inner diameter of the sixth annular wall to form the second sensing conduit between the sixth annular wall and the seventh annular wall, the second delivery conduit inboard of the seventh annular wall an eighth annular wall coupled to the fourth planar surface inboard of an exterior edge of the second base; and a ninth annular wall coupled to the fourth planar surface at the exterior edge of the second base, the eighth annular wall and the ninth annular wall forming a fifth annulus configured to receive the fourth annular wall of the first housing.

13. The connector of claim 12, wherein: the fourth annular wall of the first housing is disposed in the fifth annulus the second housing; the third annular wall passes through the third hole; the seventh annular wall passes through the second hole; and a cavity is formed inboard of the eighth annular wall, the cavity fluidly coupling the first sensing conduit and the second sensing conduit.

14. The connector of claim 12, wherein the fourth annular wall, the eighth annular wall, and the ninth annular wall are coupled to each other.

15. The connector of claim 14, wherein the fourth annular wall, the eighth annular wall, and the ninth annular wall are coupled by ultrasonic welding.

16. The connector of claim 10, wherein the second housing further comprises: a base comprising: a first planar surface; a second planar surface opposite the first planar surface; a first end; a second end opposite the first end; a first hole extending through the base from the first planar surface to the second planar surface, the first hole proximate to the first end; a second hole extending through the base from the first planar surface to the second planar surface, the second hole proximate to the second end; a first annular wall extending from the first planar surface and substantially surrounding the first hole, the first annular wall having an inner diameter coincident with a diameter of the first hole; a second annular wall extending from the second planar surface and substantially surrounding the second hole, the second annular wall having an inner diameter coincident with a diameter of the second hole; a third annular wall disposed in the second hole and coupled to the base, the third annular wall extending from the first planar surface and the second planar surface, the third annular wall having an outer diameter less than the inner diameter of the first annular wall to form the second sensing conduit between the second annular wall and the third annular wall, the second delivery conduit inboard of the third annular wall; a fourth annular wall coupled to the second planar surface inboard of an exterior edge of the base; and a fifth annular wall coupled to the second planar surface at the exterior edge of the base.

17. A system for providing instillation and negative-pressure therapy, the system comprising: an instillation source configured to provide instillation fluid; a negative-pressure source configured to provide negative -pressure and pressure sensing; a first dressing interface configured to be coupled to a dressing; a second dressing interface configured to be coupled to the dressing; a first single-lumen tube configured to be fluidly coupled to the first dressing interface; a first multi-lumen tube configured to be fluidly coupled to the second dressing interface and having a first delivery lumen and a first pressure -sensing lumen; a second single lumen tube configured to be fluidly coupled to the instillation source; a second multi-lumen tube configured to be fluidly coupled to the negative-pressure source and having a second delivery lumen and a second pressure-sensing lumen; an adapter configured to: fluidly couple the first pressure-sensing lumen of the first multi-lumen tube to the second pressure sensing lumen of the second multi-lumen tube; fluidly couple the first delivery lumen of the first multi-lumen tube to the second single lumen tube; and fluidly coupled the second delivery lumen of the second multi-lumen tube to the first single-lumen tube.

18. The system of claim 17, wherein the adapter comprises: a first housing comprising: a first receptacle having a first delivery conduit and a first sensing conduit, and a second receptacle; a second housing coupled to the first housing, the second housing comprising; a third receptacle having a second delivery conduit and a second sensing conduit, and a fourth receptacle; and the first sensing conduit being fluidly coupled to the second sensing conduit between the first housing and the second housing.

19. The system of claim 18, wherein the first housing further comprises: a base comprising: a first planar surface; a second planar surface opposite the first planar surface; a first end; a second end opposite the first end; a first hole extending through the base from the first planar surface to the second planar surface, the first hole proximate to the first end; a second hole extending through the base from the first planar surface to the second planar surface, the second hole proximate to the second end; a first annular wall extending from the first planar surface and substantially surrounding the first hole, the first annular wall having an inner diameter coincident with a diameter of the first hole; a second annular wall extending from the first planar surface and substantially surrounding the second hole, the second annular wall having an inner diameter coincident with a diameter of the second hole; a third annular wall disposed in the first hole and coupled to the base, the third annular wall extending from the first planar surface and the second planar surface, the third annular wall having an outer diameter less than the inner diameter of the first annular wall to form the first sensing conduit between the first annular wall and the third annular wall, and the first delivery conduit inboard of the third annular wall; and a fourth annular wall coupled to the second planar surface inboard of an exterior edge of the base.

20. The system of claim 19, wherein the second housing further comprises: a second base comprising: a third planar surface; a fourth planar surface opposite the third planar surface; a third end; a fourth end opposite the third end; a third hole extending through the second base from the third planar surface to the fourth planar surface, the third hole proximate to the third end; a fourth hole extending through the second base from the third planar surface to the fourth planar surface, the fourth hole proximate to the fourth end; a fifth annular wall extending from the third planar surface and substantially surrounding the third hole, the fifth annular wall having an inner diameter coincident with a diameter of the third hole; a sixth annular wall extending from the third planar surface and substantially surrounding the fourth hole, the sixth annular wall having an inner diameter coincident with a diameter of the fourth hole; a seventh annular wall disposed in the fourth hole and coupled to the second base, the seventh annular wall extending from the third planar surface and the fourth planar surface, the seventh annular wall having an outer diameter less than the inner diameter of the fifth annular wall to form the second sensing conduit between the fifth annular wall and the seventh annular wall, the second delivery conduit inboard of the seventh annular wall an eighth annular wall coupled to the fourth planar surface inboard of an exterior edge of the second base; and a ninth annular wall coupled to the fourth planar surface at the exterior edge of the second base, the eighth annular wall and the ninth annular wall forming a fifth annulus configured to receive the fourth annular wall of the first housing.

21. The system of claim 20, wherein: the fourth annular wall of the first housing is disposed in the fifth annulus the second housing; the third annular wall passes through the third hole; the seventh annular wall passes through the second hole; and a cavity is formed inboard of the eighth annular wall, the cavity fluidly coupling the first sensing conduit and the second sensing conduit.

22. The system of claim 20, wherein the fourth annular wall, the eighth annular wall, and the ninth annular wall are coupled to each other.

23. The system of claim 22, wherein the fourth annular wall, the eighth annular wall, and the ninth annular wall are coupled by ultrasonic welding.

24. The system of claim 17, further comprising: a tissue interface configured to be positioned at a tissue site; a cover configured to be positioned over the tissue interface and to seal to tissue adjacent to the tissue site; and the first dressing interface and the second dressing interface being coupled to the cover, fluidly coupled to the tissue interface, and spaced from each other.

25. A method for providing instillation therapy and negative-pressure therapy, the method comprising: providing an inline connector comprising: a first port having a first fluid path and a second fluid path, the second fluid path independent of the first fluid path; a second port having a third fluid path; a third port having a fourth fluid path and a fifth fluid path, the fifth fluid path independent of the fourth fluid path; a fourth port having a sixth fluid path; the first fluid path being fluidly coupled to the third fluid path; the second fluid path being fluidly coupled to the sixth fluid path; and the third fluid path being fluidly coupled to the fifth fluid path; providing a therapy unit having a negative-pressure delivery lumen, a pressure sensing lumen, and an instillation therapy lumen; fluidly coupling the negative-pressure delivery lumen to the fifth fluid path of the inline connector; fluidly coupling the pressure sensing lumen to the fourth fluid path of the inline connector; fluidly coupling the instillation therapy lumen to the sixth fluid path of the inline connector; fluidly coupling a first dressing to the third fluid path; and fluidly coupling a second dressing to the first fluid path and the second fluid path.

26. The method of claim 25, wherein further comprises fluidly coupling a multi -lumen tube to the first port.

27. The method of claim 26, wherein the method further comprises fluidly coupling a single-lumen tube to the fourth port, at least one lumen of the multi-lumen tube being fluidly coupled to the lumen of the single-lumen tube and at least one other lumen of the multi -lumen tube being uncoupled from the lumen of the single lumen tube.

28. The method of claim 26, wherein the multi-lumen tube is a first multi-lumen tube and the method further comprises: fluidly coupling a second multi-lumen tube to the third port; at least one of the lumens of the first multi-lumen tube is fluidly coupled to a lumen of the second multi-lumen tube; and at least one other of the lumens of the first multi -lumen tube is uncoupled from at least one other of the lumens of the second multi-lumen tube.

29. The method of claim 28, wherein the second port is configured to receive a single-lumen tube, the at least one other of the lumens of the second multi-lumen tube being fluidly coupled to the lumen of the single-lumen tube.

30. The method of claim 28, wherein the single-lumen tube is a first single-lumen tube and the method further comprises: fluidly coupling a second single lumen tube to the fourth port; and the at least one other lumens of the first multi-lumen tube being fluidly coupled to the lumen of the second single lumen tube.

31. The method of claim 25, wherein the method further comprises fluidly coupling a single-lumen tube to the second port.

32. The method of claim 25, wherein the method further comprises fluidly coupling a single-lumen tube to the fourth port. 33. The method of claim 25, wherein the method further comprises fluidly coupling a multi-lumen tube to the third port.

34. The systems, methods, and apparatuses as described herein.

Description:
TUBE-SET FOR PRESSURE MONITORING

CROSS-REFERENCE TO REUATED APPUICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/012,003, filed on April 17, 2020, which is incorporated herein by reference in its entirety.

TECHNICAU FIELD

[0002] The invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to apparatuses and methods for providing negative-pressure therapy and instillation therapy.

BACKGROUND

[0003] Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven particularly advantageous for treating wounds . Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome . Treatment of wounds or other tissue with reduced pressure may be commonly referred to as "negative-pressure therapy," but is also known by other names, including "negative- pressure wound therapy," "reduced-pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative-pressure," for example. Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.

[0004] There is also widespread acceptance that cleansing a tissue site can be highly beneficial for new tissue growth. For example, a wound or a cavity can be washed out with a liquid solution for therapeutic purposes. These practices are commonly referred to as "irrigation" and "lavage" respectively. "Instillation" is another practice that generally refers to a process of slowly introducing fluid to a tissue site and leaving the fluid for a prescribed period of time before removing the fluid. For example, instillation of topical treatment solutions over a wound bed can be combined with negative- pressure therapy to further promote wound healing by loosening soluble contaminants in a wound bed and removing infectious material. As a result, soluble bacterial burden can be decreased, contaminants removed, and the wound cleansed.

[0005] While the clinical benefits of negative-pressure therapy and instillation therapy are widely known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients. BRIEF SUMMARY

[0006] New and useful systems, apparatuses, and methods for use with negative-pressure therapy and instillation therapy are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.

[0007] Some embodiments are illustrative of an apparatus or system for use with negative pressure therapy and instillation therapy to a tissue site. For example, in some embodiments, an apparatus for connecting multi-lumen conduits is described. The apparatus can comprise a first port having a first fluid path and a second fluid path, a second port having a third fluid path, a third port having a fourth fluid path and a fifth fluid path, and a fourth port having a sixth fluid path. The second fluid path can be independent from the first fluid path and the fifth fluid path can be independent from the fourth fluid path.

[0008] Additionally or alternatively, other example embodiments describe a connector for inline fluid coupling of fluid paths of multi-lumen conduits. The connector can have a first housing and a second housing coupled to the first housing. The first housing can have a first receptacle having a first delivery conduit and a first sensing conduit and a second receptacle. The second housing can have a third receptacle having a second delivery conduit and a second sensing conduit and a fourth receptacle. The first sensing conduit can be fluidly coupled to the second sensing conduit between the first housing and the second housing.

[0009] A system for providing instillation and negative-pressure therapy is also described herein, wherein some example embodiments include an instillation source and a negative-pressure source. The instillation source can deliver instillation fluid. The negative-pressure source can be configured to provide negative-pressure and pressure sensing. The system can also include a first dressing interface and a second dressing interface. The first dressing interface and the second dressing interface can be coupled to the dressing. Embodiments of the system have a first single lumen tube and a first multi -lumen tube. The first single lumen tube can be fluidly coupled to the first dressing interface and the first multi -lumen tube can be fluidly coupled to the second dressing interface. Embodiments of the system also have a second single lumen tube and a second multi -lumen tube. The second single lumen tube can be fluidly coupled to the instillation source and the second multi-lumen tube can be fluidly coupled to the negative pressure source. In some embodiments, the first multi-lumen tube can also include a first delivery lumen and a first pressure sensing lumen and the second multi-lumen tube can include a second delivery lumen and a second pressure-sensing lumen. The system can also include an adapter. The adapter can be configured to fluidly couple the first pressure sensing lumen of the first multi -lumen tube to the second pressure sensing lumen of the second multi -lumen tube. The adapter can also be configured to fluidly couple the first delivery lumen of the first multi-lumen tube to the second single lumen tube. The adapter can also be configured to fluidly couple the second delivery lumen of the second multi-lumen tube to the first single lumen tube. [0010] A method for providing instillation therapy and negative-pressure therapy is also described herein. An inline connector can be provided. The inline connector can include a first port, a second port, a third port, and a fourth port. The first port can include a first fluid path and a second fluid path. The second fluid path can be independent of the first fluid path. The second port can have a third fluid path. The third port can have a fourth fluid path and a fifth fluid path. The fifth fluid path can be independent of the fourth fluid path. The fourth port can have a sixth fluid path. In some embodiments, the first fluid path can be fluidly coupled to the fourth fluid path, the second fluid path can be fluidly coupled to the sixth fluid path, and the third fluid path can be fluidly coupled to the fifth fluid path.

[0011] The method can also include providing a therapy unit. The therapy unit can have a negative pressure delivery lumen, a pressure sensing lumen, and an instillation therapy lumen. The method can include fluidly coupling the negative-pressure delivery lumen to the fifth fluid path of the inline connector. The method can include fluidly coupling the pressure sensing lumen to the fourth fluid path of the inline connector. The method can also include fluidly coupling the instillation therapy lumen to the sixth fluid path of the inline connector. In some embodiments, the method can further include fluidly coupling a first dressing to the third fluid path. The method can also include fluidly coupling a second dressing to the first fluid path and the second fluid path.

[0012] Objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a functional block diagram of an example embodiment of a therapy system that can provide negative-pressure treatment and instillation treatment in accordance with this specification;

[0014] Figure 2 is a schematic diagram of the therapy system of Figure 1;

[0015] Figure 3 is an exploded, perspective view of an adapter of Figure 2, illustrating additional details that may be associated with some embodiments;

[0016] Figure 4 is a cross-sectional view of the adapter taken along line 4 — 4 of Figure 2, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 2;

[0017] Figure 5 is a cross-sectional view of a tube-set with the adapter taken in the plane of Figure 2, illustrating additional details that may be associated with some embodiments;

[0018] Figure 6A is a right-side view of an exterior of a first housing of the adapter of Figure 2, illustrating additional details that may be associated with some embodiments;

[0019] Figure 6B is a left-side view of an interior of the first housing of the adapter of Figure

2;

[0020] Figure 7A is a left-side view of an exterior of a second housing of the adapter of Figure 2, illustrating additional details that may be associated with some embodiments; [0021] Figure 7B is a right-side view of an interior of the second housing of the adapter of Figure 2, illustrating additional details that may be associated with some embodiments;

[0022] Figure 8 is an exploded perspective view of the adapter with the tube set of Figure 2, illustrating additional details that may be associated with some embodiments; and

[0023] Figure 9 is an assembled perspective view of the adapter with the tube set of Figure 2, illustrating additional details that may be associated with some embodiments.

DESCRIPTION OF EXAMPLE EMBODIMENTS

[0024] The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but it may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.

[0025] The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.

[0026] Figure 1 is a simplified functional block diagram of an example embodiment of a therapy system 100 that can provide negative-pressure therapy with instillation of topical treatment solutions to a tissue site in accordance with this specification. The term “tissue site” in this context broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term “tissue site” may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to grow additional tissue that may be harvested and transplanted.

[0027] The therapy system 100 may include a source or supply of negative pressure, such as a negative-pressure source 102, and one or more distribution components. A distribution component is preferably detachable and may be disposable, reusable, or recyclable. A dressing, such as a dressing 104, and a fluid container, such as a container 106, are examples of distribution components that may be associated with some examples of the therapy system 100. As illustrated in the example of Figure 1, the dressing 104 may comprise or consist essentially of a tissue interface 108 and a cover 112, or both in some embodiments. In some embodiments, the dressing 104 may also include a dressing interface 114 to facilitate coupling the negative-pressure source 102 to the dressing 104. [0028] A fluid conductor is another illustrative example of a distribution component. A “fluid conductor,” in this context, broadly includes a tube, pipe, hose, conduit, or other structure with one or more lumina or open pathways adapted to convey a fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary. Moreover, some fluid conductors may be molded into or otherwise integrally combined with other components. Distribution components may also include or comprise interfaces or fluid ports to facilitate coupling and de-coupling other components. In some embodiments, for example, a dressing interface, such as the dressing interface 114, may facilitate coupling a fluid conductor to the dressing 104. For example, such the dressing interface 114 may be a SENSAT.R.A.C.™ Pad available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0029] The therapy system 100 may also include a regulator or controller, such as a controller 116. Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 116 indicative of the operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include a first sensor 118 and a second sensor 120 coupled to the controller 116.

[0030] The therapy system 100 may also include a source of instillation solution. For example, a solution source 122 may be fluidly coupled to the dressing 104, as illustrated in the example embodiment of Figure 1. The solution source 122 may be fluidly coupled to a positive-pressure source such as a positive-pressure source 124, a negative-pressure source such as the negative-pressure source 102, or both in some embodiments. A regulator, such as an instillation regulator 126, may also be fluidly coupled to the solution source 122 and the dressing 104 to ensure proper dosage of instillation solution (e.g. saline) to a tissue site. For example, the instillation regulator 126 may comprise a piston that can be pneumatically actuated by the negative-pressure source 102 to draw instillation solution from the solution source during a negative-pressure interval and to instill the solution to a dressing during a venting interval. Additionally or alternatively, the controller 116 may be coupled to the negative-pressure source 102, the positive-pressure source 124, or both, to control dosage of instillation solution to a tissue site. In some embodiments, the instillation regulator 126 may also be fluidly coupled to the negative -pressure source 102 through the dressing 104, as illustrated in the example of Figure 1. In some embodiments, the dressing interface 114 may facilitate coupling the solution source 122 to the dressing 104.

[0031] In some embodiments, the instillation regulator 126 may also be fluidly coupled to the negative-pressure source 102. In some embodiments, the instillation regulator 126 may be directly coupled to the negative-pressure source 102, or may be indirectly coupled to the negative-pressure source 102, as illustrated in Figure 1, through other distribution components. For example, the instillation regulator 126 may be fluidly coupled to the negative-pressure source 102 through the dressing 104. [0032] Some components of the therapy system 100 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy. For example, in some embodiments, the negative-pressure source 102 may be combined with the controller 116, the solution source 122, and other components into a therapy unit 128. The therapy unit 128 may be, for example, a V.A.C.ULTA™ Therapy Unit available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0033] In general, components of the therapy system 100 may be coupled directly or indirectly. For example, the negative-pressure source 102 may be directly coupled to the container 106 and may be indirectly coupled to the dressing 104 through the container 106. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts. For example, the negative-pressure source 102 may be electrically coupled to the controller 116 and may be fluidly coupled to one or more distribution components to provide a fluid path to a tissue site. In some embodiments, components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material.

[0034] A negative-pressure supply, such as the negative-pressure source 102, may be a reservoir of air at a negative pressure or may be a manual or electrically-powered device, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro pump, for example. “Negative pressure” generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure. While the amount and nature of negative pressure provided by the negative-pressure source 102 may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges are between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).

[0035] The container 106 is representative of a container, canister, pouch, or other storage component, which can be used to manage exudates and other fluids withdrawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with negative-pressure therapy.

[0036] A controller, such as the controller 116, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as the negative- pressure source 102. In some embodiments, for example, the controller 116 may be a microcontroller, which generally comprises an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the therapy system 100. Operating parameters may include the power applied to the negative-pressure source 102, the pressure generated by the negative-pressure source 102, or the pressure distributed to the tissue interface 108, for example. The controller 116 is also preferably configured to receive one or more input signals, such as a feedback signal, and programmed to modify one or more operating parameters based on the input signals.

[0037] Sensors, such as the first sensor 118 and the second sensor 120, are generally known in the art as any apparatus operable to detect or measure a physical phenomenon or property, and generally provide a signal indicative of the phenomenon or property that is detected or measured. For example, the first sensor 118 and the second sensor 120 may be configured to measure one or more operating parameters of the therapy system 100. In some embodiments, the first sensor 118 may be a transducer configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured. In some embodiments, for example, the first sensor 118 may be a piezo-resistive strain gauge. The second sensor 120 may optionally measure operating parameters of the negative-pressure source 102, such as a voltage or current, in some embodiments. Preferably, the signals from the first sensor 118 and the second sensor 120 are suitable as an input signal to the controller 116, but some signal conditioning may be appropriate in some embodiments. For example, the signal may need to be filtered or amplified before it can be processed by the controller 116. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.

[0038] The tissue interface 108 can be generally adapted to partially or fully contact a tissue site. The tissue interface 108 may take many forms, and may have many sizes, shapes, or thicknesses, depending on a variety of factors, such as the type of treatment being implemented or the nature and size of a tissue site. For example, the size and shape of the tissue interface 108 may be adapted to the contours of deep and irregular shaped tissue sites. Any or all of the surfaces of the tissue interface 108 may have an uneven, coarse, or jagged profile.

[0039] In some embodiments, the tissue interface 108 may comprise or consist essentially of a manifold. A manifold in this context may comprise or consist essentially of a means for collecting or distributing fluid across the tissue interface 108 under pressure. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure through multiple apertures across the tissue interface 108, which may have the effect of collecting fluid from across a tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivering fluid, such as fluid from a source of instillation solution, across a tissue site.

[0040] In some illustrative embodiments, a manifold may comprise a plurality of pathways, which can be interconnected to improve distribution or collection of fluids. In some illustrative embodiments, a manifold may comprise or consist essentially of a porous material having interconnected fluid pathways. Examples of suitable porous material that can be adapted to form interconnected fluid pathways (e.g., channels) may include cellular foam, including open-cell foam such as reticulated foam; porous tissue collections; and other porous material such as gauze or felted mat that generally include pores, edges, and/or walls. Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways. In some embodiments, a manifold may additionally or alternatively comprise projections that form interconnected fluid pathways. For example, a manifold may be molded to provide surface projections that define interconnected fluid pathways.

[0041] In some embodiments, the tissue interface 108 may comprise or consist essentially of reticulated foam having pore sizes and free volume that may vary according to needs of a prescribed therapy. For example, reticulated foam having a free volume of at least 90% may be suitable for many therapy applications, and foam having an average pore size in a range of 400-600 microns (40-50 pores per inch) may be particularly suitable for some types of therapy. The tensile strength of the tissue interface 108 may also vary according to needs of a prescribed therapy. For example, the tensile strength of foam may be increased for instillation of topical treatment solutions. The 25% compression load deflection of the tissue interface 108 may be at least 0.35 pounds per square inch, and the 65% compression load deflection may be at least 0.43 pounds per square inch. In some embodiments, the tensile strength of the tissue interface 108 may be at least 10 pounds per square inch. The tissue interface 108 may have a tear strength of at least 2.5 pounds per inch. In some embodiments, the tissue interface may be foam comprised of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds. In some examples, the tissue interface 108 may be reticulated polyurethane foam such as found in GRANUFOAM™ dressing or V.A.C. VERAFLO™ dressing, both available from Kinetic Concepts, Inc. of San Antonio, Texas.

[0042] The thickness of the tissue interface 108 may also vary according to needs of a prescribed therapy. For example, the thickness of the tissue interface may be decreased to reduce tension on peripheral tissue. The thickness of the tissue interface 108 can also affect the conformability of the tissue interface 108. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.

[0043] The tissue interface 108 may be either hydrophobic or hydrophilic. In an example in which the tissue interface 108 may be hydrophilic, the tissue interface 108 may also wick fluid away from a tissue site, while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface 108 may draw fluid away from a tissue site by capillary flow or other wicking mechanisms. An example of a hydrophilic material that may be suitable is a polyvinyl alcohol, open-cell foam such as V.A.C. WHITEFOAM™ dressing available from Kinetic Concepts, Inc. of San Antonio, Texas. Other hydrophilic foams may include those made from polyether. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity. [0044] In some embodiments, the tissue interface 108 may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, without limitation, polycarbonates, polyfumarates, and capralactones. The tissue interface 108 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 108 to promote cell -growth. A scaffold is generally a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.

[0045] In some embodiments, the cover 112 may provide a bacterial barrier and protection from physical trauma. The cover 112 may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The cover 112 may comprise or consist of, for example, an elastomeric film or membrane that can provide a seal adequate to maintain a negative pressure at a tissue site for a given negative-pressure source. The cover 112 may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least 250 grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at 38°C and 10% relative humidity (RH). In some embodiments, an MVTR up to 5,000 grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.

[0046] In some example embodiments, the cover 112 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. Such drapes typically have a thickness in the range of 25-50 microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained. The cover 112 may comprise, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers. Such materials are commercially available as, for example, Tegaderm® drape, commercially available from 3M Company, Minneapolis Minnesota; polyurethane (PU) drape, commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymer (PEBAX), for example, from Arkema S.A., Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane films, commercially available from Expopack Advanced Coatings, Wrexham, United Kingdom. In some embodiments, the cover 112 may comprise INSPIRE 2301 having an MVTR (upright cup technique) of 2600 g/m 2 /24 hours and a thickness of about 30 microns. [0047] An attachment device may be used to attach the cover 112 to an attachment surface, such as undamaged epidermis, a gasket, or another cover. The attachment device may take many forms. For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover 112 to epidermis around a tissue site. In some embodiments, for example, some or all of the cover 112 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about 25-65 grams per square meter (g.s.m ). Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks. Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.

[0048] The solution source 122 may also be representative of a container, canister, pouch, bag, or other storage component, which can provide a solution for instillation therapy. Compositions of solutions may vary according to a prescribed therapy, but examples of solutions that may be suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic solutions, and isotonic solutions.

[0049] In operation, the tissue interface 108 may be placed within, over, on, or otherwise proximate to atissue site. If the tissue site is a wound, for example, the tissue interface 108 may partially or completely fill the wound, or it may be placed over the wound. The cover 112 may be placed over the tissue interface 108 and sealed to an attachment surface near a tissue site. For example, the cover 112 may be sealed to undamaged epidermis peripheral to a tissue site. Thus, the dressing 104 can provide a sealed therapeutic environment proximate to a tissue site, substantially isolated from the external environment, and the negative-pressure source 102 can reduce pressure in the sealed therapeutic environment. Negative pressure applied across the tissue site through the tissue interface 108 in the sealed therapeutic environment can induce macrostram and microstrain in the tissue site, as well as remove exudates and other fluids from the tissue site, which can be collected in container 106.

[0050] The fluid mechanics of using a negative-pressure source to reduce pressure in another component or location, such as within a sealed therapeutic environment, can be mathematically complex. However, the basic principles of fluid mechanics applicable to negative-pressure therapy and instillation are generally well-known to those skilled in the art, and the process of reducing pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” negative pressure, for example.

[0051] In general, exudate and other fluid flow toward lower pressure along a fluid path. Thus, the term “downstream” typically implies some a position in a fluid path relatively closer to a source of negative pressure or further away from a source of positive pressure. Conversely, the term “upstream” implies a position relatively further away from a source of negative pressure or closer to a source of positive pressure. Similarly, it may be convenient to describe certain features in terms of fluid “inlet” or “outlet” in such a frame of reference. This orientation is generally presumed for purposes of describing various features and components herein. However, the fluid path may also be reversed in some applications, such as by substituting a positive-pressure source for a negative-pressure source, and this descriptive convention should not be construed as a limiting convention.

[0052] Negative pressure applied across the tissue site through the tissue interface 108 in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site. Negative pressure can also remove exudate and other fluid from a tissue site, which can be collected in container 106.

[0053] In some embodiments, the controller 116 may receive and process data from one or more sensors, such as the first sensor 118. The controller 116 may also control the operation of one or more components of the therapy system 100 to manage the pressure delivered to the tissue interface 108. In some embodiments, controller 116 may include an input for receiving a desired target pressure and may be programmed for processing data relating to the setting and inputting of the target pressure to be applied to the tissue interface 108. In some example embodiments, the target pressure may be a fixed pressure value set by an operator as the target negative pressure desired for therapy at a tissue site and then provided as input to the controller 116. The target pressure may vary from tissue site to tissue site based on the type of tissue forming a tissue site, the type of injury or wound (if any), the medical condition of the patient, and the preference of the attending physician. After selecting a desired target pressure, the controller 116 can operate the negative-pressure source 102 in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at the tissue interface 108.

[0054] Therapy systems that provide negative-pressure therapy and instillation therapy may provide both negative pressure and instillation to a tissue site through a same dressing interface. For example, the therapy unit may be coupled to a dressing interface by a multi-lumen tube. A primary lumen of the tube may be used to instill fluid to the dressing through the dressing interface, and at the conclusion of the instillation therapy, the therapy unit may draw fluid from the dressing through the primary lumen to provide negative-pressure therapy. The therapy unit may determine the pressure at the tissue site through a pressure sensor disposed at the tissue site or through a plurality of secondary lumens in the multi-lumen tube. Providing instillation and negative -pressure therapy through a single tube may decrease the efficiency of both therapies. In addition, instilling fluid or drawing fluid across a pressure sensor or across the secondary lumens may interfere with the determination of a pressure at the tissue site.

[0055] Some systems separate the provision of instillation therapy and negative-pressure therapy by using separate dressing interfaces for each therapy. A first dressing interface can be positioned at a first location, and a second dressing interface can be positioned at a second location on the same dressing. Instillation fluid may be delivered to the first dressing interface, and negative pressure may be delivered to the second dressing interface. As the instillation therapy cycle concludes and the negative-pressure therapy cycle begins, the instilled fluid may travel across the dressing from the first location to the second location. While instillation therapy and negative-pressure therapy may be separated into separate dressing interfaces, pressure sensing may still be associated with the negative- pressure therapy. For example, pressure sensing lumens are often located at the second location where negative pressure is being delivered. At the conclusion of the instillation cycle and beginning of the negative-pressure therapy cycle, instilled fluid may be drawn across the pressure -sensing lumens, potentially causing blockages in the pressure-sensing lumens that may inhibit accurate pressure sensing. Furthermore, sensing pressure at the location of delivery of negative-pressure therapy may provide only a partial picture of the pressure at a tissue site.

[0056] These issues and others can be addressed by the therapy system 100, which can position the pressure sensing and negative-pressure therapy at different locations of a tissue site. Sensing pressure at a different location than negative-pressure therapy may improve the efficiency of pressure determination at the tissue site and improve delivery of negative-pressure therapy and instillation therapy. For example, if the pressure sensing lumens are located at the first location where instillation fluid is being delivered, fluid and exudate may flow in a direction away from the pressure sensing lumens and towards the source of negative pressure. Thus, fluid and exudate is less likely to contact the pressure sensing lumens, reducing the risks of clogging and blocking of the pressure sensing lumens. Furthermore, during a negative-pressure therapy cycle, the determined pressure may provide a fuller picture of the pressure at the tissue site.

[0057] Figure 2 is a schematic diagram of an example embodiment of the therapy system 100 configured to apply negative pressure and instillation fluid to a tissue site 202. The therapy system 100 can generally include the therapy unit 128, a tube-set 200, and the dressing 104. The tube-set 200 may fluidly couple the therapy unit 128 to the dressing 104. In some embodiments, the dressing interface 114 may comprise more than one dressing interface. For example, the dressing interface 114 may comprise two dressing interfaces, a first dressing interface 204 and a second dressing interface 206. The first dressing interface 204 and the second dressing interface 206 may be coupled to the cover 112. Each of the first dressing interface 204 and the second dressing interface 206 can be configured to provide a fluid coupling to the tissue interface 108 through the cover 112. In some embodiments, the first dressing interface 204 can be positioned at a first location, and the second dressing interface 206 can be positioned at a second location. For example, the first dressing interface 204 and the second dressing interface 206 may be placed at opposing ends of the tissue site 202. For example, the tissue site 202 may be elongated having a rectangular or elongated ovular shape. The first location may be proximate to a short edge of the tissue site, and the second location may be proximate to another short edge of the tissue site that is separated from the first location by about a maximum length of the tissue site. The negative-pressure source 102 may be fluidly coupled to the first dressing interface 204, and the solution source 122 may be fluidly coupled to the second dressing interface 206.

[0058] In some example embodiments, the tube-set 200 may include an in-line connector, such as an adapter 224, a first single lumen tube 208, and a first multi-lumen tube 210. The first single lumen tube 208 may be configured to be fluidly coupled to the first dressing interface 204, and the first multi- lumen tube 10 may be configured to be fluidly coupled to the second dressing interface 206. The tube- set 200 may further include a second single lumen tube 216, and a second multi-lumen tube 218. The second single lumen tube 216 may be configured to be fluidly coupled to the solution source 122, and the second multi-lumen tube 218 may be configured to be fluidly coupled to the negative-pressure source 102. In some embodiments, the first single lumen tube 208 and the second single lumen tube 216 may be examples of a fluid conductor and can each be an extruded tube having a single lumen. In some embodiments, the first single lumen tube 208 may comprise a first lumen 226, and the second single lumen tube 216 may comprise a second lumen 228.

[0059] In some example embodiments, the first multi-lumen tube 210 and the second multi lumen tube 218 may be examples of a fluid conductor and can each be an extruded tube having at least two lumens. In some embodiments, the at least two lumens may be side-by-side. In other embodiments, the first multi-lumen tube 210 and the second multi-lumen tube 218 may be an extruded tube having a central lumen and a plurality of peripheral lumens surrounding the central lumen. The plurality of peripheral lumens can be a plurality of pressure sensing lumens. In some embodiments, the plurality of pressure sensing lumens may provide lumen redundancy. For example, as fluid is drawn through the first multi-lumen tube 210 and the second multi-lumen tube 218, one or more of the plurality of pressure sensing lumens may become blocked. An availability of additional lumens may permit pressure to continue being sensed at the tissue site. In still other embodiments, the first multi-lumen tube 210 and the second multi-lumen tube 218 may compnse a first film layer welded to a second film layer. A plurality of features may project into a sealed space formed between the first film layer and the second film layer. The plurality of features may maintain an open pathway while also disrupting exudate flow to break up clots and thick exudate.

[0060] The first multi-lumen tube 210 may comprise a first delivery lumen 212 and a first pressure sensing lumen 214. The second multi -lumen tube 218 may comprise a second delivery lumen 220 and a second pressure sensing lumen 222. In some embodiments, the adapter 224 may fluidly couple the first pressure sensing lumen 214 to the second pressure sensing lumen 222 to form a sensing pathway. The sensing pathway may fluidly couple the therapy unit 128 to the second dressing interface 206 for sensing negative pressure at the tissue interface 108. For example, the sensing pathway may be fluidly coupled to one of more of the first sensor 118 and the second sensor 120 for determination of a pressure at the tissue site 202.

[0061] The adapter 224 may also be configured to fluidly couple the second lumen 228 to the first delivery lumen 212 to form an instillation pathway. The instillation pathway may fluidly couple the solution source 122 to the second dressing interface 206 for delivering instillation solution to the tissue interface 108. The adapter 224 may be further configured to fluidly couple the first lumen 226 to the second delivery lumen 220 to form a negative pressure pathway. The negative pressure pathway may fluidly couple the negative-pressure source 102 to the first dressing interface 204 to deliver negative pressure to the tissue interface 108. [0062] Additionally or alternatively, the therapy system 100 may be used without the solution source 122. In some embodiments, the second single lumen tube 216 that fluidly couples the solution source 122 to the adapter 224 may be removed. An end cap or plug having the same inner diameter and outer diameter as the second single lumen tube 216 may be coupled to the adapter 224 in place of the second single lumen tube 216. In some embodiments, the end cap may be bonded to the adapter 224. In some embodiments, the first dressing interface 204 may deliver negative-pressure to the tissue site 202, and the second dressing interface 206 may sense pressure at the tissue site 202 separate from the first dressing interface 204.

[0063] In other example embodiments, the first dressing interface 204 and the second dressing interface 206 may be placed across a plurality of wounds. For example, the first dressing interface 204 may be positioned on a dressing covering a first tissue site, and the second dressing interface 206 may be positioned on a dressing covering a second tissue site. The two dressings may be fluidly coupled by a bridge dressing permitting negative-pressure to be distributed to the two dressings from a single negative-pressure source. Negative-pressure can be provided to the first dressing interface 204, and the pressure sensing components can be fluidly coupled to the second dressing interface 206. The pressure for the first tissue site and the second tissue can be determined by measuring the pressure at the tissue site that is not directly receiving negative-pressure therapy. Additional tissue sites can be monitored provided that the second dressing interface 206 be applied to the tissue site that is last in the fluid chain from the first dressing interface 204.

[0064] Figure 3 is an exploded, perspective view of the adapter 224, illustrating additional details that may be associated with some embodiments. The adapter 224 may comprise a first housing 302 and a second housing 304. The first housing 302 may compnse a base portion, such as a first base 306. The first base 306 may comprise a first planar surface 308 and a second planar surface 310 (not shown) opposite the first planar surface 308. The first base 306 may also include a first end 312 and a second end 314 opposite the first end 312. Additionally, the first housing 302 may comprise a first annular wall 316 proximate to the first end 312 and a second annular wall 318 proximate to the second end 314. The first annular wall 316 and the second annular wall 318 may each be coupled to and extend from the first planar surface 308 of the first housing 302. In some embodiments, the first housing 302 may also include a third annular wall 320 inboard of the first annular wall 316. In some embodiments, the first housing 302 may also include a seventh annular wall 338 coupled to and extending from the second planar surface 310. The seventh annular wall 338 may be inboard of an exterior edge of the first base 306.

[0065] The second housing 304 may comprise a base portion, such as a second base 322. The second base 322 may comprise a third planar surface 324 and a fourth planar surface 326 (not shown) opposite the third planar surface 324. The second base 322 may further comprise a third end 328 and a fourth end 330 opposite the third end 328. Additionally, the second housing 304 may include a fourth annular wall 332 proximate to the third end 328 and a fifth annular wall 334 proximate to the fourth end 330. The fourth annular wall 332 and the fifth annular wall 334 may be coupled to and extend from the fourth planar surface 326. In some embodiments, the second housing 304 may also include a sixth annular wall 336 inboard of the fifth annular wall 334.

[0066] In some embodiments, the second housing 304 may also include an eighth annular wall 340 and a ninth annular wall 342. The eighth annular wall 340 maybe coupled to the third planar surface 324 and extend outward from the third planar surface 324. The eighth annular wall 340 may also be coupled to an exterior edge of the second base 322 and extend outward from the third planar surface 324. The ninth annular wall 342 may be inboard of the exterior edge of the second base 322. In some embodiments, the ninth annular wall 342 is inboard of the eighth annular wall 340. The eighth annular wall 340 and the ninth annular wall 342 may form an annulus 343 adapted to receive a portion of the first housing 302. For example, the annulus 343 may be adapted to receive the seventh annular wall 338 of the first housing 302 to couple the first housing 302 to the second housing 304. In some embodiments, the seventh annular wall 338, the eighth annular wall 340, and the ninth annular wall 342 may be coupled to each other, for example, by ultrasonic welding, a friction fit, or by being adhered to each other.

[0067] Figure 4 is a cross-sectional view of the adapter 224 taken along line 4 — 4 of Figure 2, illustrating additional details that may be associated with some embodiments of the therapy system of Figure 2. In some embodiments, the first housing 302 may comprise a first receptacle 400 and a second receptacle 402. The first annular wall 316 may form the first receptacle 400 and the second annular wall 318 may form the second receptacle 402. The first receptacle 400 may have a first fluid path 404 and a second fluid path 406 independent of the first fluid path 404. The second receptacle 402 may have a third fluid path 408. In some embodiments, the third annular wall 320 may include a portion extending from the first planar surface 308 into a portion of the first receptacle 400 and another portion extending from the second planar surface 310. The third annular wall 320 may have an outer diameter less than an inner diameter of the first annular wall 316 to form the first fluid path 404 through the first receptacle 400 between the first annular wall 316 and the third annular wall 320. The second fluid path 406 may be formed through the first receptacle 400 and inboard of the third annular wall 320.

[0068] In some embodiments, the second housing 304 may comprise a third receptacle 410 and a fourth receptacle 412. The fifth annular wall 334 may form the third receptacle 410 and the fourth annular wall 332 may form the fourth receptacle 412. The third receptacle 410 may have a fourth fluid path 414 and a fifth fluid path 416 independent of the fourth fluid path 414. The fourth receptacle 412 may have a sixth fluid path 418. In some embodiments, the sixth annular wall 336 may include a portion extending from the fourth planar surface 326 into a portion of the third receptacle 410 and another portion extending from the third planar surface 324 The sixth annular wall 336 may have an outer diameter less than an inner diameter of the fifth annular wall 334 to form the fourth fluid path 414 through the third receptacle 410 between the fifth annular wall 334 and the sixth annular wall 336. The fifth fluid path 416 may be formed through the third receptacle 410 and inboard of the sixth annular wall 336.

[0069] Figure 5 is a cross-sectional view of the tube-set 200 with the adapter 224 taken in the plane of Figure 2, illustrating additional details that may be associated with some embodiments. In some embodiments, the first receptacle 400 of the adapter 224 may be configured to receive a multi-lumen tube, such as the first multi-lumen tube 210. At least one lumen of the first multi -lumen tube 210 may be fluidly coupled to the first fluid path 404 and at least one other lumen of the first multi-lumen tube 210 may be fluidly coupled to the second fluid path 406. For example, the first pressure sensing lumen 214 of the first multi -lumen tube 210 may be fluidly coupled to the first fluid path 404, and the first delivery lumen 212 of the first multi-lumen tube 210 may be fluidly coupled to the second fluid path 406. The second receptacle 402 of the adapter 224 may be configured to receive a single-lumen tube, such as the first single lumen tube 208. The first lumen 226 of the first single lumen tube 208 may be fluidly coupled to the third fluid path 408.

[0070] The third receptacle 410 of the adapter 224 may be configured to receive another multi lumen tube, such as the second multi-lumen tube 218. At least one lumen of the second multi-lumen tube 218 may be fluidly coupled to the fourth fluid path 414 and at least one other lumen of the second multi -lumen tube 218 may be fluidly coupled to the fifth fluid path 416. For example, the second pressure sensing lumen 222 of the second multi-lumen tube 218 may be fluidly coupled to the fourth fluid path 414, and the second delivery lumen 220 of the second multi-lumen tube 218 may be fluidly coupled to the fifth fluid path 416. The fourth receptacle 412 of the adapter 224 may be configured to receive another single-lumen tube, such as the second single lumen tube 216. The second lumen 228 may be fluidly coupled to the sixth fluid path 418.

[0071] As mentioned above, the first housing 302 may be coupled to the second housing 304. The eighth annular wall 340 and the ninth annular wall 342 of the second housing 304 may receive the seventh annular wall 338 of the first housing 302 to couple the first housing 302 to the second housing 304. In some embodiments, a cavity 500 is formed between the first housing 302 and the second housing 304 when the first housing 302 and the second housing 304 are coupled. The cavity 500 may be formed inboard of the ninth annular wall 342 and between the first housing 302 and the second housing 304. In some embodiments, the first pressure sensing lumen 214 and the second pressure-sensing lumen 222 may be fluidly coupled via the cavity 00 to form the sensing pathway comprising the first fluid path 404, the cavity 500, and the fourth fluid path 414. Additionally, the first delivery lumen 212 of the first multi -lumen tube 210 may be fluidly coupled to the second lumen 228 of the second single lumen tube 216 via the second fluid path 406 and the sixth fluid path 418 to form the instillation pathway. The second delivery lumen 220 of the second multi -lumen tube 218 may be fluidly coupled to the first lumen 226 of the first single lumen tube 208 via the third fluid path 408 and the fifth fluid path 416 to form the negative pressure pathway. [0072] Referring to Figure 6A and Figure 6B, the first housing 302 may comprise a first hole 600 and a second hole 602, each hole extending through the first base 306 from the first planar surface 308 to the second planar surface 310. The first hole 600 may be proximate to the first end 312 and the second hole 602 may be proximate the second end 314. The first hole 600 of the first housing 302 may be associated with the first receptacle 400 and the second hole 602 of the first housing 302 may be associated with the second receptacle 402. The first annular wall 316 may substantially surround the first hole 600 and have an inner diameter coincident with a diameter of the first hole 600. For example, in some embodiments, the inner diameter of the first hole 600 may be about 6 mm to about 8 mm, and the outer diameter of the first annular wall 316 may be about 9 mm to about 12 mm. The second annular wall 318 may substantially surround the second hole 602 and have an inner diameter coincident with a diameter of the second hole 602. For example, in some embodiments the inner diameter of the second hole 602 may be about 5 mm to about 8 mm, and the inner diameter of the second annular wall 318 may be about 8 mm to about 12 mm. Additionally, the third annular wall 320 may be disposed in the first hole 600 and coupled to the first base 306. In some embodiments, the third annular wall 320 may have an inner diameter of about 2 mm to about 4 mm. The first hole 600 may comprise the first fluid path 404 and the second fluid path 406 independent of the first fluid path 404. The second hole 602 may comprise the third fluid path 408

[0073] Referring to Figure 7A and Figure 7B, the second housing 304 may comprise a third hole 700 proximate to the third end 328 and a fourth hole 702 proximate to the fourth end 330. The third hole 700 and the fourth hole 702 may each extend through the second base 322 from the third planar surface 324 to the fourth planar surface 326. The third hole 700 may be associated with the fourth receptacle 412 and the fourth hole 702 may be associated with the third receptacle 410. The fourth annular wall 332 may substantially surround the third hole 700 and have an inner diameter coincident with a diameter of the third hole 700. For example, in some embodiments the inner diameter of the third hole 700 may be about 5 mm to about 8 mm, and the inner diameter of the fourth annular wall 332 may be about 8 mm to about 12 mm. The fifth annular wall 334 may substantially surround the fourth hole 702 and have an inner diameter coincident with a diameter of the fourth hole 702. For example, in some embodiments the inner diameter of the fourth hole 702 may be about 6 mm to about 8 mm, and the outer diameter of the fifth annular wall 334 may be about 9 mm to about 12 mm. In some embodiments, the sixth annular wall 336 may be disposed in the fourth hole 702 and coupled to the second base 322. In some embodiments, the sixth annular wall 336 may have an inner diameter of about 2 mm to about 4 mm. The fourth hole 702 may comprise the fourth fluid path 414 and the fifth fluid path 416 independent of the fourth fluid path 414. The third hole 700 may comprise the sixth fluid path 418.

[0074] Figure 8 is an exploded perspective view of the adapter 224 with the tube-set 200 of Figure 2, illustrating additional details that may be associated with some embodiments. In some embodiments, the portion of the third annular wall 320 extending from the first planar surface 308 may be configured to engage the first multi-lumen tube 210. If the first housing 302 and the second housing 304 are coupled, the portion of the third annular wall 320 extending from the second planar surface 310 may pass through the third hole 700 into a portion of the fourth receptacle 412 of the second housing 304 and be configured to engage the second single lumen tube 216. The third annular wall 320 may fluidly isolate the first delivery lumen 212 from the first pressure sensing lumen 214. The third annular wall 320 may also fluidly couple the first delivery lumen 212 to the second lumen 228 of the second single lumen tube 216. In some embodiments, the portion of the sixth annular wall 336 extending from the fourth planar surface 326 may be configured to engage the second multi-lumen tube 218. If the first housing 302 and the second housing 304 are coupled, the portion of the sixth annular wall 336 extending from the third planar surface 324 may pass through the second hole 602 into a portion of the second receptacle 402 of the first housing 302 and be configured to engage the first single lumen tube 208. The sixth annular wall 336 may fluidly isolate the second delivery lumen 220 from the second pressure sensing lumen 222. The sixth annular wall 336 may also fluidly couple the second delivery lumen 220 to the first single lumen tube 208.

[0075] Figure 9 is an assembled, perspective view of an embodiment of the tube-set 200. As shown in Figure 9, the first housing 302 and the second housing 304 are coupled together to form the adapter 224. The first receptacle 400, the second receptacle 402, the third receptacle 410, and the fourth receptacle 412 of the adapter 224 may be configured to receive a lumen or conduit. For example, the first receptacle 400 may receive the first multi -lumen tube 210, the second receptacle 402 may receive the first single lumen tube 208, the third receptacle 410 may receive the second multi -lumen tube 218, and the fourth receptacle 412 may receive the second single lumen tube 216.

[0076] According to an illustrative embodiment, a method for providing instillation therapy and negative-pressure therapy is further provided. The method includes providing an inline connecter, such as the adapter 224. The adapter 224 may include a plurality of ports, for example, the first receptacle 400, the second receptacle 402, the third receptacle 410, and the fourth receptacle 412. The first receptacle 400 may comprise the first fluid path 404 and the second fluid path 406 independent of the first fluid path 404. The second receptacle 402 may comprise the third fluid path 408. The third receptacle may comprise the fourth fluid path 414 and the fifth fluid path 416 independent from the fourth fluid path 414. The fourth receptacle 412 may comprise the sixth fluid path 418. Additionally, the adapter 224 may fluidly couple the first fluid path 404 to the fourth fluid path 414, the second fluid path 406 to the sixth fluid path 418, and the third fluid path 408 to the fifth fluid path 416.

[0077] The method may further include providing a therapy unit, such as the therapy unit 128. The therapy unit 128 may comprise a negative pressure delivery lumen, at least one pressure sensing lumen, and an instillation therapy lumen. The method may include fluidly coupling the negative pressure delivery lumen, such as the second delivery lumen 220, to the fifth fluid path 416; the at least one pressure sensing lumen, such as the second pressure sensing lumen 222, to the fourth fluid path 414; and the instillation therapy lumen, such as the second single lumen tube 216, to the sixth fluid path 418. The method may further include fluidly coupling the first dressing interface 204 to the third fluid path 408 and fluidly coupling the second dressing interface 206 to both the first fluid path 404 and the second fluid path 406. For example, the first single lumen tube 208 may fluidly couple the first dressing interface 204 to the third fluid path 408, and the first pressure sensing lumen 214 and the first delivery lumen 212 may fluidly couple the second dressing interface 206 to the first fluid path 404 and the second fluid path 406, respectively.

[0078] In some embodiments, the method may comprise fluidly coupling a multi-lumen tube to the first receptacle 400 of the adapter 224. Additionally, the method may comprise fluidly coupling a single lumen tube to the fourth receptacle of the adapter 224. In such an embodiment, at least one lumen of the multi-lumen tube may be fluidly coupled to the single lumen tube and at least one other lumen of the multi-lumen tube may be uncoupled from the single lumen tube. In some embodiments, the method may also comprise fluidly coupling another single lumen tube to the second receptacle 402 and fluidly coupling another multi-lumen tube to the third receptacle 410.

[0079] In other embodiments, the multi-lumen tube may be a first multi-lumen tube, such as the first multi -lumen tube 210, and the method may further comprise fluidly coupling a second multi lumen tube, such as the second multi -lumen tube 218, to the third receptacle 410 of the adapter 224. In such embodiments, at least one lumen of the first multi-lumen tube 210 may be fluidly coupled to a lumen of the second multi -lumen tube 218 and at least one other lumen of the first multi-lumen tube 210 may be uncoupled from at least one other of the lumens of the second multi -lumen tube 218. The method may further comprise fluidly coupling a single lumen tube to the second receptacle 402 of the adapter 224. The single lumen tube may be fluidly coupled to the at least one other lumen of the second multi -lumen tube 218. In some embodiments, the single lumen tube may be a first single lumen tube, such as the first single lumen tube 208. The method may further comprise fluidly coupling a second single lumen tube, such as the second single lumen tube 216, to the fourth receptacle 412. In such embodiments, the at least one other lumens of the first multi-lumen tube 210 may be fluidly coupled to the lumen of the second single lumen tube 216.

[0080] In operation, the negative-pressure source 102 supplies negative pressure to the tissue interface 108 via the tube-set 200 and the first dressing interface 204. For example, negative pressure supplied from the negative-pressure source 102 travels through the second delivery lumen 220 of the second multi -lumen tube 218, through the fifth fluid path 416 and the third fluid path 408 of the adapter 224, and through the first lumen 226 of the first single lumen tube 208 to the first dressing interface 204. The solution source 122 supplies instillation fluid to the tissue interface 108 via the tube-set 200 and the second dressing interface 206. For example, instillation fluid travels through the second lumen 228 of the second single lumen tube 216, through the sixth fluid path 418 and the second fluid path 406 of the adapter 224, and through the first delivery lumen 212 of the first multi -lumen tube 210 to the second dressing interface 206. The instillation fluid then travels across the tissue site 202 from the second dressing interface 206 to the first dressing interface 204. The instillation fluid and any wound exudate may be removed by the negative-pressure source 102. [0081] Pressure at the tissue site 202 may be measured at the second dressing interface 206 where instillation fluid is supplied. The second pressure sensing lumen 222 of the second multi-lumen tube 218 is fluidly coupled to the negative-pressure source 102 and the adapter 224. The first pressure sensing lumens 214 are fluidly coupled to the adapter 224 and the second dressing interface 206. The adapter 224 fluidly isolates the second pressure sensing lumens 222 from the second delivery lumen 220 of the second multi-lumen tube 218. The adapter 224 also fluidly isolates the first delivery lumen 212 from the first pressure sensing lumens 214 of the first multi-lumen tube 210. The adapter 224 fluidly couples the second pressure sensing lumens 222 of the second multi -lumen tube 218 to the first pressure sensing lumens 214 of the first multi-lumen tube 210 via the fourth fluid path 414, the cavity 500, and the first fluid path 404.

[0082] The systems, apparatuses, and methods described herein may provide significant advantages. For example, the embodiments described herein provide a connector or adapter 224 that can fluidly isolate the second delivery lumen 220 from the second pressure sensing lumen 222 of the second multi -lumen tube 218, allowing the second delivery lumen 220 to be fluidly coupled to the first dressing interface 204 and the second pressure sensing lumen 222 to be fluidly coupled to the second dressing interface 206 at opposing sides of the tissue site 202. This arrangement allows pressure sensing to be separate from negative pressure delivery which enables the therapy system to monitor the pressure of the whole wound between the first dressing interface 204 and the second dressing interface 206. Additionally, this arrangement reduces the risk of overpressure and allows the therapy system to ensure that the pressure sensing lumens are subjected to at least -125mmHg.

[0083] Another advantage is that the therapy system can ensure that the dressing interface components are in pneumatic connection with the wound and each other to reduce errors and blockages. Further, the risk of clogging and blocking is reduced because fluid and exudate flows away from the pressure sensing lumens towards the negative pressure lumens rather than towards and over the pressure sensing lumens.

[0084] While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context. Components may be also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations the dressing 104, the container 106, or both may be eliminated or separated from other components for manufacture or sale. In other example configurations, the controller 116 may also be manufactured, configured, assembled, or sold independently of other components.

[0085] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.