Apparatus for administering reduced pressure treatment to a tissue site

(54) Title: APPARATUS AND METHOD FOR THE ADMINISTRATION OF REDUCED PRESSURE TO A TISSUE SITE (30) Unionist Priority: 02/09/2007 us 60 / 900,415 (73) Holder (s): kci licensing inc.

(72) Inventor (s): blane sanders, christopher brian LOCKE, IAN JAMES HARDMAN, JONATHAN PAUL JAEB, KEITH PATRICKHEATON, KRITINE KIESWETTER, MARKSTEPHAN JAMES BEARD, ROYCE W. JOHNSON, SHANNON C. INGRAM, ΤΙΜΟΤΗΥ MARK ROKINS (74) (s): David do Nascimento Advogados Associados (86) International Request: pct US08001741 of 08/02/02 (87) International Publication: W0 2008 / I00446de2i / 08/2008 (57) Summary: apparatus and method for the administration of REDUCED PRESSURE TO A FABRIC SITE. The illustrative embodiments described in the present invention relate to a system and method for the administration of reduced pressure to a tissue site. The device includes a source of reduced pressure. The reduced pressure source generates reduced pressure. The apparatus includes a tube that has a plurality of lumens. The plurality of lumens includes at least one collection lumen. The reduced pressure source applies reduced pressure to the tissue site through the plurality of lumens in such a way that at least one collection lumen receives fluid from the tissue site. At least one collection lumen stores the fluid received from the tissue site.

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APPARATUS AND METHOD FOR THE ADMINISTRATION OF REDUCED PRESSURE TO A TISSUE SITE

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

The present invention relates generally to the field of tissue treatment and, more specifically, to a system and method for applying reduced pressure to a tissue site.

DESCRIPTION OF THE RELATED TECHNIQUE

Clinical studies and practice have shown that the provision of reduced pressure in proximity to a tissue site increases and accelerates the growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but the application with reduced pressure has been particularly successful in the treatment of wounds. The treatment of wounds using reduced pressure is sometimes referred to in the medical community as treatment of tissue with negative pressure, therapy with reduced pressure or vacuum therapy. This type of treatment provides a series of benefits, which include faster healing and increased formulation of the tissue under healing.

Low pressure treatment systems are often applied to large, highly exuding wounds present in patients who are undergoing acute or chronic care, as well as other serious wounds that are not readily susceptible to healing without application under reduced pressure. Low-severity wounds that are smaller in volume and produce less exudate are usually treated by using advanced dressings instead of treatment with reduced pressure.

Currently, the use of treatment with reduced pressure is not considered a viable or inexpensive option for low-severity wounds due to the labor required

2/36 to monitor and change system components, the need for trained medical personnel to monitor treatment, and the high cost of treatment. For example, the complexity of today's low pressure treatment systems makes it impossible for a person with little specialized knowledge to administer such treatment to himself or others. The characteristics of energy consumption and the size of current low pressure treatment systems also limit the mobility of the treatment system and the person to whom the treatment is being applied. In addition, the high cost of today's low pressure treatment systems may make it impossible for some users to access such treatment systems. Current low pressure treatment systems are also typically not disposable after each treatment.

For example, current low pressure treatment systems require the use of a separate fluid container for storing the exudate that is extracted from the tissue site. However, the inclusion of the added component of a fluid container increases the obstructive character, complexity and weight of the reduced pressure treatment system, thereby increasing discomfort and limiting the patient's mobility.

Current reduced pressure treatment systems also lack non-obstructive methods that are harmless to the user to indicate whether an adequate amount with reduced pressure is being applied to the tissue site by the reduced pressure treatment system. Therefore, people with specialized knowledge are required in order to correctly operate the reduced pressure treatment system, thereby increasing the cost and decreasing the accessibility of using the reduced pressure treatment system.

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Although reduced pressure can be applied to low-volume, low-exudate wounds when using traditional reduced pressure treatment systems, there is a need for a simpler system that allows reduced pressure treatment to be administered without specialized medical training. There is also a need for a system that uses little energy and is compact, allowing a user of the system to continue moving and participate in normal daily activities. Finally, a system that is cheap is needed, so that the system can be used economically by a single patient and is then discarded at the end of treatment by that patient.

BRIEF DESCRIPTION OF THE INVENTION

To minimize the problems with low pressure treatment systems, the illustrative embodiments described in the present invention relate to an apparatus and a method for administering reduced pressure to a tissue site. The device includes a source of reduced pressure. The reduced pressure source generates reduced pressure. The apparatus includes a tube that has a plurality of lumens. The plurality of lumens includes at least one collection lumen. The reduced pressure source applies reduced pressure to the tissue site through the plurality of lumens in such a way that at least one collection lumen receives fluid from the tissue site. At least one collection lumen stores the fluid received from the tissue site.

In another embodiment, the apparatus includes an indicator that can be moved to a plurality of positions. In this embodiment, the indicator moves to a retracted position in the plurality of positions in the presence of reduced pressure from the reduced pressure source. The device can also include a

4/36 compressible element coupled to the indicator. The compressible element exerts a driving force on the indicator towards an extended position in the plurality of positions. Other objectives, characteristics and advantages of the invention will become apparent with reference to the drawings, the detailed description and the following claims.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a block diagram of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 2 is a block diagram of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

to components

Figure 3 is a cross-sectional view of an apparatus for the administration of reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 4 is a cross-sectional view of the components of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 5 is a cross-sectional view of the components of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 6 is a cross-sectional view of the components of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 7 is a cross-sectional view of the components of an apparatus for administering pressure

5/36 reduced to a tissue site according to an illustrative embodiment of the present invention;

Figure 8 is a cross-sectional view of the components of an apparatus for administering reduced pressure to a tissue site according to an embodiment

<td colspan="3">illustrative of the present invention;</td><td rowspan="2">in cross section of the</td>

<td>The</td><td>Figure 9 is</td><td>a view</td>

<td>components</td><td colspan="2">of an appliance for</td><td>pressure management</td>

<td>reduced to</td><td>a place of</td><td>fabric of</td><td>according to an achievement</td>

<td>illustrative</td><td>of this</td><td>invention;</td><td></td>

Figure 10 is a block diagram of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 11 is a perspective view of the components of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 12 is a perspective view of the components of an apparatus for administering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 13 is a perspective view of the components of an apparatus for the administration of reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 14 is a graphical representation of a system for delivering reduced pressure to a tissue site according to an illustrative embodiment of the present invention;

Figure 15 is a flow chart illustrating a process for delivering reduced pressure to a tissue site according to an illustrative embodiment of the present invention; and Figure 16 is a flow chart that illustrates a process

6/36 for administering the reduced pressure to a tissue site according to an illustrative embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED ACHIEVEMENT

In the detailed description of the preferred embodiments below, reference is made to the accompanying drawings that form part of it and which are shown by the specific preferred embodiments of the illustration in which the invention can be practiced. These achievements are described in sufficient detail to allow elements skilled in the art to practice the invention and it should be understood that other achievements can be used and that logical, structural, mechanical, electrical and chemical changes can be made without deviating from the character or the scope of the invention. To avoid unnecessary details and allow elements skilled in the art to practice the invention, the description may omit certain information known to elements skilled in the art. The following detailed description is therefore not to be considered in a limiting sense, and the scope of the present invention is defined only by the appended claims.

The illustrative embodiments described in the present invention present an apparatus and a method for administering reduced pressure to a tissue site. The reduced pressure generally refers to a pressure less than the ambient pressure at a tissue site that is being treated. In most cases, this reduced pressure will be less than the atmospheric pressure of the location where the patient is located. Although the terms vacuum and negative pressure can be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site can be significantly less than the pressure normally associated with a total vacuum. Consistent with this nomenclature, an increase in pressure

7/36 reduced or vacuum pressure refers to a relative reduction in absolute pressure, whereas a decrease in reduced pressure or vacuum pressure refers to a relative increase in absolute pressure. Similarly, a reduced pressure that is less than a particular reduced pressure refers to an absolute pressure that is greater than the absolute pressure that corresponds to the particular reduced pressure. In addition, a reduced pressure that is greater than a particular reduced pressure refers to an absolute pressure that is less than the absolute pressure that corresponds to the particular reduced pressure.

<td></td><td>The apparatus may include a</td><td>source</td><td>in</td><td>pressure</td>

<td>reduced.</td><td>The reduced pressure source</td><td>generates</td><td>an</td><td>pressure</td>

<td>reduced.</td><td>In one embodiment, the device</td><td>includes</td><td>one</td><td>tube that</td>

it has a plurality of lumens. The plurality of lumens includes at least one collection lumen. The reduced pressure source applies reduced pressure to the tissue site through the plurality of lumens in such a way that at least one collection lumen receives fluid from the tissue site. At least one collection lumen stores the fluid received from the tissue site.

In another embodiment, the apparatus includes an indicator that can be moved to a plurality of positions. For example, the indicator can be a cylindrical indicator contained in an indicator housing that is coupled between two portions of an application tube. The delivery tube can be used to apply reduced pressure to a tissue site. In one example, the indicator moves to a stowed position in the plurality of positions in the presence of reduced pressure from the reduced pressure source. A compressible element can be attached to the indicator. As used in the present invention, the term coupled includes coupling through a separate object. For example, the

8/36 compressible element can be attached to the indicator if the filter set and the tube are attached to a third object. The coupled term also includes directly coupled, in which case the two objects touch in some way. The coupled term also encompasses two or more components that are continuous with each other because each component is formed from the same piece of material. The compressible element can exert a driving force on the indicator towards an extended position in the plurality of positions.

Referring now to Figure 1, a reduced pressure treatment system 100, which applies the reduced pressure to a tissue site 105, is shown according to an illustrative embodiment. The tissue site 105 can be the body tissue of any human, animal or other organism, which includes bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other fabric. Although tissue site 105 may include a wound, diseased tissue or defective tissue, the tissue site may also be healthy tissue that is not injured, diseased or defective. The application with reduced pressure to the tissue site 105 can be used to promote drainage of exudate and other liquids from the tissue site 105, as well as to stimulate the growth of additional tissue. In the case where the tissue site 105 is a wound site, the growth of the tissue under healing and the removal of exudates and bacteria promote wound healing. Application with reduced pressure to an uninjured tissue or

0 Non-defective, which includes healthy tissue, can be used to promote tissue growth that can be collected and transplanted to another tissue site.

The reduced pressure that is applied to the

9/36 fabric 105 is generated by a reduced pressure source 110. The reduced pressure source 110 can be any type of pump operated manually, mechanically or electrically. Non-limiting examples of the reduced pressure source 110 include devices that are powered by stored energy, and that have the capacity to produce reduced pressure. Examples of such sources of reduced pressure with stored energy include, without limitation, pumps powered by piezoelectric energy, spring energy, solar energy, kinetic energy, energy stored in capacitors, combustion and energy developed by Sterling or similar cycles. Other examples of the reduced pressure source 110 include devices that are manually activated, such as bellows pumps, peristaltic pumps, diaphragm pumps, pumps. rotating vanes, linear piston pumps, pneumatic pumps, hydraulic pumps, hand pumps, foot pumps and hand pumps such as those used with manually activated spray bottles. Still other devices and processes that can be used or included in the reduced pressure source 110 include syringes, actuating screws, ratchets, clock-driven devices, pendulum-powered devices, manual generators, osmotic processes, thermal heating processes and processes in that vacuum pressures are generated by condensation.

In another embodiment, the reduced pressure source 110 may include a pump that is moved by a chemical reaction. A tablet, solution, spray or other application mechanism can be applied to the pump and used to initiate the chemical reaction. The heat generated by the chemical reaction can be used to drive the pump to produce the reduced pressure. In another embodiment, a pressurized gas cylinder such as a CO₂ Is it used

10/36 to drive a pump to produce the reduced pressure. However, in another embodiment, the reduced pressure source 110 may be a battery powered pump. Preferably, the pump uses low amounts of energy and can be operated for an extended period of time on a single battery charge.

The reduced pressure source 110 provides the reduced pressure to the tissue site 105 through a dressing 115. The dressing 115 includes a dispenser 120, which can be placed adjacent or in contact with the tissue site 105. The dispenser 120 can be a biocompatible and porous material that can be brought into contact with the tissue site 105 and which distributes the reduced pressure to the tissue site 105. The dispenser 120 can be made of foam, gauze, felt mat or any other material suitable for a particular biological application. The dispenser 120 may include a plurality of channels or flow passages to facilitate the distribution of the reduced pressure or fluids to or from the tissue site 105.

In one embodiment, distributor 120 is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be an open cell, polyurethane foam, crosslinked foam such as GranuFoam manufactured by Kinetic Concepts, Inc. of San Antonio, Texas. If an open cell foam is used, the porosity may vary, but is preferably approximately 400 to 600 microns. The flow channels allow fluid communication throughout the portion of the distributor 120 which has open cells. Cells and flow channels can be uniform in shape and size, or they can include modeled or random variations in shape and size. Variations in the shape and size of the distributor cells result in variations

11/36 polyglycolic include, without (PGA). The limitation in the flow channels and such characteristics can be used to change the characteristics of fluid flow through the distributor 120.

The dispenser 120 can also be constructed from bioresorbable materials that do not have to be removed from a patient's body after using the reduced pressure treatment system 100. Appropriate bioresorbable materials may include, without limitation, a polymeric acid mixture polylactic (PLA) and polymeric acid mix can also polycarbonates, polyfumarates and caprolactones. The distributor 120 can additionally serve as a support structure for the growth of new cells, or a support structure material can be used in conjunction with the distributor 120 to promote cell growth. A support structure is a substance or structure used to enhance or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of support structure materials include calcium phosphate, collagen, PLA / PGA, coral apatite hydroxy, carbonates or processed allograft materials. In one example, the material of the support structure has a high fraction of empty spaces (i.e., a high air content).

Dressing 115 also includes a sealing element 125. The dispenser 120 can be attached to the fabric site 105 by using a sealing element 125. The sealing element 125 can be a cover that is used to secure the dispenser 120 to the site of fabric 105. Although sealing element 125 may be impermeable or semi-permeable, in one example, sealing element 125 is able to maintain a reduced pressure at the fabric site 105 after installation of the

12/36 sealing element 125 over dispenser 120. Sealing element 125 can be a bandage or flexible film made of a compound based on silicone, acrylic, hydrogel or hydrogel-forming material, or any other biocompatible material that includes the desired impermeability or permeability characteristics for the tissue site 105. The sealing element 125 can be formed from a hydrophobic material to prevent absorption of moisture by the sealing element 125.

Instead of being provided in the form of a sheet such as a bandage, the sealing element 125 can be provided in a form so that it can be poured or sprayed, to be applied on the dispenser 120 after placing the dispenser 120 in contact with the tissue site 105. Similarly, the sealing element 125 may include a device that is placed over the dispenser 120 and the fabric site 105 to provide sealing functionality, which includes, but is not limited to, a suction cup, a hollow mold and a glass bell jar.

0 In one embodiment, the sealing element 125 is configured to provide a sealed connection with the distributor surrounding the fabric 120 and the fabric site 105. The sealed connection can be provided by an adhesive positioned along a perimeter of the sealing element 125 or on any portion of the sealing element 125 to secure the sealing element 125 to the dispenser 120 or to the surrounding tissue to the tissue site 105. 0 adhesive can be pre-positioned on the sealing element 125 or it can be sprayed or otherwise applied to the sealing element 125 just before installing the sealing element 125.

In some cases, sealing element 125 may not be required to seal tissue site 105. For example,

13/36 the tissue site 105 can be self-sealing to maintain reduced pressure. In the case of deep and subcutaneous wounds in the tissue, cavities and fistulas, maintaining reduced pressure at the tissue site 105 may be possible without the use of the sealing element 125. Since the tissue often surrounds or surrounds these types of tissue sites, tissue, the tissue surrounding the tissue site acts effectively as a sealing element.

The reduced pressure generated by the reduced pressure source 110 can be applied to the tissue site 105 using an application tube 135. The application tube 135 can be any tube through which a gas, liquid, gel or other fluid can flow. For example, exudate from the tissue site 105 can flow through the delivery tube 135. In Figure 1, the connector 150 couples the delivery tube 135 to a fluid collection apparatus 140. However, the delivery tube 135 can directly couple the reduced pressure source 110 to the dressing 115 without the intervention connector 150 or fluid collection apparatus 140.

The application tube 135 can have any shape in cross section, such as circular, oval or polygonal. In addition, application tube 135 can be made of any material and can be flexible or inflexible. In addition, the delivery tube 135 can include one or more passages or lumens through which the fluid can flow. For example, the application tube 135 can include two lumens. In this example, a lumen can be used to pass the exudate from the tissue site 105 to the fluid collection apparatus 140. The other lumen can be used to apply fluids, such as air, antibacterial agents, antiviral agents, promotion agents from the growth of cells, irrigation fluids, or other chemically active agents, to the tissue site 105. The source of fluid from which

14/36 these liquids originate is not shown in Figure 1.

In one embodiment, the delivery tube 135 includes an application lumen and one or more collection lumens to collect exudate from the tissue site 105. These lumens can also include a filter to control the flow of exudate through the lumens. Additional details regarding the inclusion of application lumens, collection lumens and filters in application tube 135 are provided below in Figures 2-10.

In one embodiment, the delivery tube 135 is coupled to the distributor 120 via a connecting element 145. The connecting element 145 allows fluid to pass from the distributor 120 to the application tube 135, and vice versa. For example, exudates collected from tissue site 105 using dispenser 120 can enter application tube 135 through connection element 145. In another embodiment, the reduced pressure treatment system 100 does not include connection element 145. In this embodiment, the application tube 135 can be inserted directly into the sealing element 125 or the distributor 120 in such a way that one end of the application tube 135 is adjacent or in contact with the distributor 120.

The reduced pressure treatment system 100 includes fluid collection apparatus 140. A liquid, such as exudate, from tissue site 105, can flow through the application tube 135 to fluid collection apparatus 140. The apparatus fluid collection tube 140 can be any device or cavity capable of containing a fluid, such as gases and liquids, as well as fluids containing solids. For example, canister 115 may contain exudates from the tissue site 105. The application tube 135 can be directly connected to the fluid collection device 140 or can be coupled to the fluid collection device 140 via

15/36 of a connector, such as connector 150.

The fluid collection apparatus 140 may be a flexible or rigid vessel, a bag or pouch fluidly connected to the dispenser 120 by the delivery tube 135. The fluid collection apparatus 140 may be a separate container or may be combined operably with the reduced pressure source 110 to collect the exudate and liquids. In an illustrative embodiment in which a hand pump, such as a bellows pump, is used as a source of reduced pressure 110, the variable volume chamber that generates the reduced pressure can also serve as a fluid collection device 140, collecting fluid at as the chamber expands. Fluid collection apparatus 140 may include a single chamber for collecting fluids or alternatively may include multiple chambers. A desiccant or absorbent material can be disposed within the fluid collection apparatus 1.4 0 to capture or control the fluid once

The ecoletado. In the absence of the fluid collection device 140, a method can be employed to control the exudate and other fluids in which fluids, especially those that are soluble in water, can evaporate from the dispenser 120. In another embodiment, one or more lumens of collection in the application tube 135, which will be described below in Figure 2-10, can be used in place of or in addition to the fluid collection device 140.

The reduced pressure treatment system 100 includes a reduced pressure feedback system 155 operably associated with the other components of the reduced pressure treatment system 100 to provide information to a user of the reduced pressure treatment system 100 that indicates that a relative or absolute amount of pressure is being applied to the tissue site 105 or is being generated by the reduced pressure source 110.

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Examples of feedback systems include, without limitation, safety valves that are activated when the reduced pressure rises above a selected value, and deflection safety valves. Additional details regarding the feedback systems that include the safety valves and, in particular, the mobile indicators that respond to the reduced pressure in the application tube 135, are provided below with respect to Figures 11-14.

Other non-limiting examples of feedback systems include low power electronic indicators powered by tiny cells, selector indicators that indicate specific values ​​of pressure being applied to the tissue site, polymers with various deflection characteristics and films that move relative to each other to produce visual identifiers that indicate the relative or absolute pressure values ​​that are being generated by the reduced pressure source 110. An example of a base system film can include a yellow film anchored to a first part of the reduced pressure source 110 which can move relative to a blue film anchored to a second part. When the first and second parts are moved relative to each other to apply reduced pressure, the yellow and blue films overlap to create a green indicator. As the pressure increases and the films move away from each other, the loss of green color indicates that the pressure has increased (that is, more reduced pressure needs to be applied).

reduced pressure treatment system 100 may additionally include a volume detection system 157 for detecting the amount of fluid present in the fluid collection apparatus 140, a blood detection system 159 for detecting the presence of blood in the exudate extracted from the site tissue 105, a monitoring system for

17/36 temperature 162 to monitor the temperature of the tissue site 105, an infection detection system 165 to detect the presence of infection at the tissue site 105 and a flow monitoring system to monitor the flow of fluids extracted from the tissue site tissue 105. Infection detection system 165 may include foam or another substance that changes color in the presence of bacteria. The foam or other substance can be operably associated with the dispenser 120 or the application tube 135, in such a way that the color-changing material is exposed to the exudate from the tissue site 105. In addition to the above-mentioned components and systems, the reduced pressure treatment system 100 may include valves, regulators, switches and other electrical, mechanical and fluid components to facilitate administration of the reduced pressure treatment to the tissue site 105.

Referring now to Figure 2, the reduced pressure treatment system 200, which is a non-limiting example of the reduced pressure treatment system 100 in Figure 1, is shown according to an illustrative embodiment. In one embodiment, the fluid collection apparatus 140 in Figure 1 is tube 235 fluidly connected between dressing 215 and the reduced pressure source 210. 0 dressing 215 and reduced pressure source 210 are non-limiting examples of dressing 115 and reduced pressure source 110 in Figure 1, respectively.

tube 235 includes a plurality of lumens. In particular, tube 235 includes an application lumen 270 and a plurality of collection lumens 272. Although Figure 2 shows tube 235 as having a single application lumen 270 and two collection lumens 272, tube 235 can have any number of application and collection lumens. For example, multiple application lumens and a single collection lumen can be

18/36 included in tube 235.

All the lumens of the plurality of lumens in the tube 235, including the application lumen 270 and the plurality of collection lumens 272, are fluidly connected to the reduced pressure source 210 in such a way that all are exposed to the reduced pressure. In this way, the reduced pressure generated by the reduced pressure source 210 can be transmitted through each lumen of the plurality of lumens in the tube 235 to the tissue site 205 through the dressing 215. In one embodiment, the reduced pressure source 210 applies reduced pressure to the tissue site 205 through application lumen 270 and the plurality of collection lumens 272 in such a way that the plurality of collection lumens 272 receives a fluid 274, such as a liquid or a liquid containing solids, from tissue site 205. In one example, fluid 274 is exudate from tissue site 205. The plurality of collection lumens 272 can store fluid 274 received from tissue site 205 . In this way, the need for a separate fluid collection device, such as the fluid collection device 140 in Figure 1, is eliminated.

The reduced pressure treatment system 200 may include at least one filter coupled to tube 235. In particular, tube 235 includes an application lumen filter 276 and a collection lumen filter 278. The application lumen filter 276 and the collection lumen filter 278 prevents fluid 274 from tissue site 205 from passing or flowing near one or more locations in which the filters are located. The application lumen filter 276 and the collection lumen filter 278 can be any type of filter capable of preventing fluid flow 274, such as a hydrophobic filter, a hydrophilic filter and a mechanical valve. In the example where the application lumen filter 276 or the collection lumen filter 278 is a mechanical valve, a

19/36 one way, such as a duckbill valve, can be used.

application lumen filter 276 is coupled to the end of tube 235 which is adjacent to tissue site 205 and dressing 215. As used in the present invention, adjacent means on or near another object. In an example, a first object can be adjacent to a particular object if the first object is closer to the particular object than a second object. Thus, a first end of the tube 235 can be adjacent to the tissue site 205 if the first end of the tube is closer to the tissue site 205 than a second end of the tube. The application lumen filter 276 prevents or prevents fluid 274 from entering application lumen 270 through dressing 215. In this way, the reduced pressure can be continuously applied through the application lumen 270 unobstructed by fluid 274, even if fluid 274 is collected in the plurality of collection lumens 274.

Although Figure 2 shows the application lumen filter 276 preventing fluid 274 from entering application lumen 270, the application lumen filter 276 can also be positioned to prevent fluid 274 from passing from a particular point along application lumen 270. For example, the application lumen filter 276 can be placed inside application lumen 270 at a particular distance from one end of tube 235 in such a way that fluid 274 is drawn into a portion of application lumen 270 unobstructed by the 276 application lumen filter. Additional details regarding the placement and coupling of the 276 application lumen filter are provided in Figures 4-6 below.

The collection lumen filter 278 is coupled to the

20/36 end of tube 235 which is adjacent to the reduced pressure source 210. The collection lumen filter 278 prevents fluid 274 from entering the reduced pressure source 210 or leaving the plurality of collection lumens 272. Due to the location of the collection lumen filter 278, the plurality of collection lumens 272 between the dressing 215 and the collection lumen filter 278 are reservoirs capable of receiving exudate and other fluids from the tissue site 205. Since the plurality of collection lumens 272 is influenced by the reduced pressure source 210, fluids are drawn from the tissue site 205 through the dispenser 220, which is adjacent to the tissue site 205, to the plurality of collection lumens 272 . The volume of space available for the fluid depends on the diameter and number of collection lumens in the plurality of collection lumens 272, as well as the length of each collection lumen between the dressing 215 and the collection lumen filter 278. For example , the plurality of collection lumens 272 may have the capacity to hold approximately 30-60 cubic centimeters of fluid 274. However, the aforementioned physical parameters of the plurality of collection lumens 272 can be adjusted based on the particular design, in such a way that the plurality of collection lumens 272 can store any amount of fluid 274.

As the plurality of collection lumens 272 is filled with fluid, the plurality of collection lumens 272 continues to transmit the reduced pressure from the reduced pressure source 210. When the plurality of collection lumens 272 is completely filled with fluid 274 between the dressing 215 and the collection lumen filter 278, the reduced pressure can no longer be transmitted through the plurality of collection lumens 272. However, application lumen 270 continues to transmit the reduced pressure even after the plurality of collection lumens 272 is full.

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Although the collection lumen filter 278 is shown to be coupled to the end of tube 235 that is adjacent to the reduced pressure source 210, the collection lumen filter 278 can be located anywhere along tube 235. For example, the collection lumen filter 278 can be located at a midpoint along the length of tube 235. In this example, the plurality of collection lumens 272 can be filled with fluid 274 until fluid 274 is blocked by the collection lumen filter 278 at the midpoint of tube 235. In this way, the collection lumen filter 278 prevents fluid 274 passes from the midpoint of tube 235 along the plurality of collection lumens 272. In this example, only a portion of the space defined by the plurality of collection lumens 272 can be filled with fluid 274.

In another example, the reduced pressure treatment system 200 may include multiple collection lumen filters. In this example, each collection lumen filter can be located in a different location along each collection lumen in the plurality of collection lumens 272. Thus, each collection lumen in the plurality of collection lumens 272 can have a capacity of different fluid.

Since the reduced pressure treatment system 200 can be used for the treatment of low exudative tissue sites, the smaller volume of collection fluid provided by the plurality of collection lumens 272 (as opposed to a dedicated canister) has almost no no effect on the capacity of the reduced pressure treatment system 200 to provide treatment for an extended period of time. The compact nature of a fluid collection device that is integrated into an application tube with reduced pressure minimizes patient discomfort and maximizes patient mobility. During treatment, when

22/36 plurality of collection lumens 272 is completely filled with fluid 274, tube 235 can be easily replaced with a new tube. To minimize the risk of spilling fluid during pipe changes, or having a counterflow of fluid in the dispenser 220 during treatment, the plurality of collection lumens 272 can be partially filled or conditioned with desiccants, absorbent materials or other capture agents .

In Figure 2, the portion of the plurality of collection lumens 272 containing fluid 274 is shaded to show that fluid 271 is visible to a user of the reduced pressure treatment system 200. Tube 235 may include at least a portion substantially transparent tube through which fluid 274 can be visible. For example, one or more substantially transparent portions of the tube may be a window in the tube 235 made of a transparent material. Each of these windows can extend through the portions of the tube 235 that are adjacent to each respective collection lumen 272.

In another example, the material from which the tube 235 is made can be a transparent material. In this way, fluid 274 may be visible due to the full transparency of tube 235. Since fluid 274 from tissue site 205, such as exudate, may be darkened in color, fluid levels within the plurality of collection lumens 272 can be easily determined by a user.

Tube 235 also includes demarcations 280. Demarcations 280 indicate an amount of fluid 274 in the plurality of collection lumens 272. In the example where tube 235 includes one or more substantially transparent portions of the tube, such as transparent windows, the demarcations 280 can be included along each of the windows. Each of the 28 0 demarcations can correspond to a volume or to

23/36 a specific amount of fluid 274. For example, the first of the demarcations 280 can be labeled as 5 cc and each following demarcation can be labeled in increments of 5 cubic centimeters. The particular increment used may depend on the execution.

Referring now to Figure 3, a cross-sectional view of tube 300 is shown from the perspective of the cross-section indicator labeled as Fig 3 in Figure 2. As shown in Figure 3, the application lumen 270 has a larger cross section than each of the collection lumens 272. However, in one example, the cross section of the application lumen 270 may be equal to or less than the cross section of each of the collection lumens 272. Application lumen 270 and collection lumens 272 also have a circular cross-sectional shape. However, the application lumen 270 and collection lumens 272 can have any cross-sectional shape, such as an oval, polygonal or irregular cross-sectional shape.

Each of the collection lumens 272 is shown as equidistant from the application lumen 270 in such a way that the collection lumens 272 surround the application lumen 270 in a circular pattern. However, application lumen 270 and collection lumens 272 can have any spatial configuration with respect to each other, including configurations where each collection lumen 272 is at a different distance from application lumen 270. In addition, tube 300 can include two or more application lumens, such as application lumen 270. Any number of collection lumens 272 can also be included in tube 300. In one example, the number of application lumens in the tube 300 exceeds the number of collection lumens.

It is also shown that the application lumen 270 is located along the longitudinal center of the tube 300. In the

However, application lumen 270 can be located along any longitudinal axis that runs the length of tube 300. In one example, application lumen 270 and collection lumens 272 can be defined by the walls extending longitudinally across the length of the tube 300. In this example, two or more intersecting walls can define quadrants, any of which can be an application lumen or a collection lumen.

With reference now to Figure 4, a cross-sectional view of the tube 400 is shown from the perspective of the cross-section indicator labeled as Fig 4 in Figure 2. The tube 400 includes the application tube filter 276, which is coupled to the tube 400 at the opening of the application lumen 270. The application tube filter 276 can have the same cross section or a slightly larger cross section than the application lumen 270 to ensure that the application tube filter 276 can prevent fluid from entering the application lumen 270. 0 application lumen filter 276 can be attached to the end of tube 400 using any method. For example, the application lumen filter 276 can be welded, threaded, glued, screwed, sealed to the air passage, trapped by pressure or pressed at the end of the tube 400.

Referring now to Figure 5, a cross-sectional view of the tube 500 is shown from the perspective of the cross-section indicator labeled as Fig 5 in Figure 4. Figure 5 shows the application lumen opening 270 obstructed by the lumen filter application 276 of a

0 in such a way that the fluid from a tissue site cannot enter the application lumen 270. In particular, it is shown that the application lumen filter 270 is the part located outside the application lumen 270 in such a way

25/36 that the application lumen filter 270 projects over the diameter of the application lumen 270 in the hanging portions 277. The application lumen filter 276 can be of any thickness sufficient to prevent the flow of fluid in the application lumen 270. The openings in the collection lumens 272 are not blocked by the application lumen filter 276 in such a way that the fluid can be received and collected by the collection lumens 272.

Referring now to Figure 6, a cross-sectional view of tube 600 is shown, in which the application lumen filter 276 has a different size and configuration than the application lumen filter 276 in Figure 5

In particular, the application lumen filter 276 has a diameter approximately equal to the diameter of the application tube 270 in such a way that the application lumen filter 276 fits within the space defined by the application lumen 270. Although it is shown that the application lumen filter 276 is positioned at the end of application lumen 270, application lumen filter 276 can be located anywhere along the length of application lumen 270. In this example, the application lumen filter 276 prevents fluid from a tissue site to pass to the location where the application lumen filter 276 is located along application lumen 270.

With reference now to Figure 7, a cross-sectional view of tube 700 is shown from the perspective of the cross-section indicator labeled as Fig 7 in Figure 2. Tube 700 includes the collection lumen filter 278. It is shown that the collection lumen filter 278 is coupled to one end of the tube 700. It is also shown that the collection lumen filter 278 is detached from the end of the tube 700 to better show the shape of the collection lumen filter. The collection lumen filter 278 is a disc

26/36 that has an opening 279. When coupled to the end of tube 700, the collection lumen filter 278 covers collection lumen 272, but does not cover application lumen 270, since opening 279 is located in the opening application lumen 270. In this way, the collection lumen filter 278 can prevent the fluid that was collected by the collection lumen filter 278 from leaving the collection lumen 272 and entering a reduced pressure source, such as the reduced pressure source 210 in Figure 2. However, the reduced pressure can still be applied through the collection lumen filter 278 in such a way that the collection lumens 272 can transmit the reduced pressure to a tissue site. Although it is shown that the application lumen filter 278 has an O shape, it is shown that the collection lumen filter

278 has any shape that can prevent the fluid from leaving one or more collection lumens 272.

collection lumen filter 278 can be attached to the end of tube 700 using any method. For example, the collection lumen filter 278 can be welded, threaded, glued, screwed, sealed to the air passage, trapped by pressure or pressed at the end of the tube 700.

Referring now to Figure 8, a cross-sectional view of tube 500 is shown from the perspective of the cross-section indicator labeled as Fig 8 in

Figure 7. Figure 8 shows the collection lumen opening 272 obstructed by the collection lumen filter 278 in such a way that fluid from a tissue site cannot leave the collection lumens 272 or enter a reduced pressure source . In particular, it is shown that the collection lumen filter 278 is located on the outside of the collection lumens 272 in such a way that the collection lumen filter 278 projects over each diameter of each collection lumen 272. The collection lumen filter 278 can have any

27/36 thick enough to prevent fluid flow out of the collection lumens 278. The opening of the application lumen 270 is not obstructed by the collection lumen filter 278 in such a way that there is no impediment between the opening of the collection lumen. application 270 and a reduced pressure source.

Referring now to Figure 9, a cross-sectional view of tube 900 is shown, in which the collection lumen filter 278 has a different size and configuration than the collection lumen filter 278 in Figure 8. In particular, the filter collection lumen 278 includes multiple collection lumen filters, each of which is located within the space defined by collection lumens 272. 0 diameter of each collection lumen filter 278 is approximately equal to the diameter of each collection lumen 272 in such a way that the collection lumen filter 278 fits into the collection lumens 272. In this example, each of the collection lumen filters it may consist of mechanical valves that prevent the flow of liquid, such as exudate, but do not prevent the flow of gas, thereby allowing the flow of reduced pressure through the collection lumen filter 278. Although the collection lumen filter 278 is shown positioned at the ends of each collection lumen 272, the collection lumen filter 278 can be located anywhere along the length of the collection lumens 272, thereby defining a fluid capacity for each collection lumen 272. Each of the collection lumen filters 278 may also be located at different locations along each respective collection lumen 272 in such a way that each collection lumen 272 has a different fluid capacity.

With reference now to Figure 10, the reduced pressure treatment system 1000, which is a non-limiting example 28/36 of the reduced pressure system 100 in Figure 1, is shown according to an illustrative embodiment. In particular, the reduced pressure treatment system 1000 includes a non-limiting example of the reduced pressure feedback system 155 in Figure 1. 0 reduced pressure treatment system 1000 includes the reduced pressure source 1010, which generates a reduced pressure that can be applied to the tissue site 1005.

reduced pressure treatment system 1000 also includes the indicator housing 1000, which is disposed between two portions of the application tube 1035. The application tube 1035 is a non-limiting example of the application tube 135 in Figure 1. The housing 1000 of the indicator includes the connecting portion 1086. The connecting portion 1086 transmits the reduced pressure from one portion of the delivery tube 1035 to another portion of the delivery tube 1035. The connection portion 1086 also contains an equal or similar amount of reduced pressure as that contained by the delivery tube 1035. The indicator housing 1000 includes the indicator 1088, which is slidably coupled to an opening along the portion of the pipe 1090 of the indicator housing 1085. The 1088 indicator can be cylindrical in shape. The indicator 1088 can have an oval or polygonal cross-sectional shape. 0 indicator 1088 can also have any color, such as red, orange or yellow.

<td></td><td>0 indicator 1088</td><td>respond to</td><td>an</td><td>amount</td><td>in</td>

<td>pressure</td><td>reduced present</td><td>in the system</td><td>in</td><td>treatment</td><td>with</td>

<td>pressure</td><td>reduced 1000 from a</td><td>such way</td><td>what</td><td colspan="2">a user can</td>

<td colspan="3">determine whether a desired amount</td><td>or</td><td>therapy</td><td>gives</td>

reduced pressure is being applied to tissue site 1005. In particular, indicator 1088 can be moved to a plurality of positions along axis 1092. The plurality of positions can include a retracted position. In position

29/36 retracted, the indicator 1088 can be totally or partially retracted in the portion of the tube 1090 in such a way that the indicator 1088 is totally or partially not visible to a user. The plurality of positions can also include an extended position. In Figure 10, indicator 1088 is shown in the extended position. In the extended position, the indicator 1088 can project totally or partially from the portion of the tube 1090 in such a way that the indicator 1088 is visible by a user. The plurality of positions can also include any position between a fully extended and a fully retracted position.

The reduced pressure treatment system 1000 also includes a compressible element, such as a spring, which is coupled to indicator 1088 and positioned on the portion of tube 1090. The compressible element is not shown in Figure 10, but will be described in more detail. in Figures 11 and 12 below. The compressible element exerts a driving force on the indicator 1088 which pushes the indicator 1088 towards the extended position. The driving force is exerted in the direction indicated by arrow 1093.

Although the casing of indicator 1085 is shown to be disposed between two portions of the application tube 1035, the casing of indicator 1085 can be positioned anywhere in the reduced pressure treatment system 1000 where a reduced pressure being applied to the site of tissue 1005 can be detected. For example, the indicator casing 1085, together with the indicator 1088, can be positioned anywhere on the dressing 1015, including the sealing element 1025 or the connector 1045. The dotted indicator 1094 shows the example where the indicator casing 1085 , together with indicator 1088, is positioned on sealing element 1025. In another example, the housing of indicator 1085, together with indicator 1088,

30/36 can be positioned on either end of a single application tube that couples the 1010 reduced pressure source to the 1015 dressing.

In one embodiment, indicator 1088 moves to a stowed position in the presence of reduced pressure from the reduced pressure source 1010. In particular, indicator 1088 can move to the stowed position when reduced pressure is present in the delivery tube 1035 and in connection portion 1086. When moving to the stowed position, indicator 108 8 must overcome the driving force being exerted by the compressible element in the direction indicated by arrow 1093. A sufficiently high reduced pressure in the connection portion 1086 can overcome this driving force and pull the indicator 1088 to the stowed position. The amount of reduced pressure that is required to overcome the bias force may depend on the amount of bias force exerted by the compressible element. In the example where the compressible element is a spiral spring, the elasticity constant of the spiral spring determines the amount of reduced pressure required to pull the indicator 1088 to the retracted position.

In one example, indicator 108 8 moves to the stowed position when the reduced pressure in the delivery tube 1035 exceeds a first reduced pressure limit. The first limit of the reduced pressure can be determined by a user and can be implemented by varying the driving force exerted by the compressible element. For example, a user can select a compressible element with a constant elasticity that requires the reduced pressure in the 1035 delivery tube to exceed a reduced therapeutic pressure in order for the 1088 indicator to be pulled into the stowed position. In one embodiment, the 1088 indicator moves to the stowed position when an absolute pressure generated

31/36 by the reduced pressure source is equal to or less than approximately 125 millimeters of mercury. In this way, a user of the reduced pressure treatment system 1000 can visually detect when a reduced therapeutic pressure is being applied to tissue site 1005 by noting that indicator 1088 does not protrude from the 1090 tube portion.

In another embodiment, the compressible element can urge the indicator 1088 to the extended position when the reduced pressure in the delivery tube 1035 is less than a second reduced pressure limit. In one example, the first reduced pressure limit is the same as the second reduced pressure limit. In another example, the first reduced pressure limit is different from the second reduced pressure limit in such a way that the indicator is in an entirely retracted position when the reduced pressure exceeds the first reduced pressure limit and is in an entirely extended position when the reduced pressure is less than the second reduced pressure limit. In this embodiment, indicator 1088 may be in an intermediate position between the fully retracted and fully extended position when the reduced pressure is between the first and the second reduced pressure limits.

In another embodiment, the compressible element pushes the indicator 1088 to the extended position in the absence with reduced pressure in the application tube 1035. In one example, the absence with reduced pressure is due to the fact that the reduced pressure source 1010 is turned off. Since the compressible element in the tube portion 1090 pushes the indicator 1088 so that it protrudes from the tube portion 1090 when the reduced pressure is absent or below a threshold amount, a user can visually detect when a therapeutic pressure is not being applied. applied to the site

32/36 tissue 1005 when observing that indicator 1088 projects from the portion of tube 1090. The user can then perform the necessary action to apply a therapeutic pressure to the site of tissue 1005. One reason why the reduced pressure in the application tube 1035 may be absent or below a limit quantity is due to a leak in the 1035 application tube or elsewhere in the reduced pressure treatment system 1000. In this circumstance, a user is alerted to a possible leak when the indicator

1088 is in the extended position.

With reference now to Figure 11, a reduced pressure feedback system 1100, such as that shown in Figure 10, is shown according to an illustrative embodiment. In particular, indicator 1088 is in an extended position in the reduced pressure feedback system 1100.

The connecting portion 1086 is slidably coupled with the two portions of the delivery tube 1035 to form a sealed fit. The connecting portion 1086 of the indicator housing 1085 can also be sealably coupled with the two portions of the delivery tube 1035 in a variety of ways. For example, the connection portion 1086 can be welded, threaded, glued, screwed, sealed to the passage of air or pressurized to the two portions of the 1035 delivery tube.

In the reduced pressure feedback system

1100, the compressible element is a spiral spring. The tube portion 1090 of the indicator housing 1085 includes the base 1096, to which an end of the coiled spring 1095 is attached. However, the end of the spiral spring 1095 that is not attached to the indicator 108 8 can be joined to any other component of the indicator housing with which a spiral spring can be used to exert a force of

33/36 push on indicator 1088. The inner surface of the 1090 tube portion is a tubular opening along which the indicator 1088 can slide into the retracted and extended positions. The coiled spring 1095 is contained by a plurality of corrugations 1097 that form part of a tubular wall. Corrugations 1097 allow the tubular wall to be compressed and expanded without causing lateral stress to the inner wall of the 1090 tubular portion.

The reduced pressure feedback system 1100 10 also includes cover 1098. Cover 1098 can be made of a transparent material that allows a user to view indicator 1088 when indicator 1088 is in the extended position. In one example, the cap 1098 is also sealingly coupled with the rest of the indicator housing 1085 so that the reduced pressure does not escape through the tubular opening in the indicator housing 1085.

As discussed above, spiral spring 1095 can have any elasticity constant. The elasticity constant of the spiral spring 1095 determines the driving force that is exerted on the indicator 1088 to the extended position. In one embodiment, the spiral spring 1095 has a constant elasticity in such a way that the spiral spring 1095 pushes the indicator 1088 to the extended position when an absolute pressure in the application tube

1035 exceeds approximately 125 millimeters of mercury. Other spiral springs that have other spring constants can also be used to urge the 1088 indicator to the extended position when the absolute pressure in the 1035 delivery tube exceeds other absolute pressure limits, such as the desired therapeutic pressure limits.

Referring now to Figure 12, the reduced pressure feedback system 1200, which is a non-limiting example of the reduced pressure feedback system

34/36

1100, is shown according to an illustrative embodiment. In particular, the reduced pressure feedback system 1200 shows indicator 1088 in a stowed position. When indicator 1088 is in a retracted position, the reduced pressure of application tube 1035 is transferred to indicator 1088 through the tubular wall formed from corrugations 1097. This reduced pressure exerts a tensile force on the indicator 1088 which is sufficient to overcome the driving force exerted by the spiral spring 1095 in the opposite direction. The indicator 1088 is thus pulled out of the transparent cover 10 98 and out of a user's view of the reduced pressure treatment system. The absence of indicator 1088 on cover 1098 indicates to a user that a therapeutic pressure is being administered to the tissue site. In another embodiment, the cap 1098 can be coupled to the indicator 1088 in such a way that the cap 1098 is also retracted to the portion of the tube 1090 when the indicator 1088 is in the retracted position.

Referring now to Figure 13, the reduced pressure feedback system 1300, which is a non-limiting example of the reduced pressure feedback system shown in Figure 10, is shown in an illustrative embodiment. The perspective view of Figure 13 shows the circular cross section of indicator 1088, cover 1098, tube portion 1090, as well as the opening 1099 through which indicator 1088 projects. These components, however, can have any shape in cross section, such as oval or polygonal.

Referring now to Figure 14, a graph showing the relationship between the reduced pressure in the application tube 1035 and the position of the indicator 1088 is shown according to an illustrative embodiment. As shown in graph 1400, as the reduced pressure in the

35/36 application 1035 increases, indicator 1088 moves towards the fully retracted position. In one embodiment, indicator 1088 moves to the complete stowed position in a linear fashion, as indicated by the line in graph 1410. The relationship between reduced pressure and the position of indicator 1088 can also follow other patterns, as indicated by graph lines 1415 and 1420. Other patterns, such as a stair step pattern, can also characterize the relationship between the reduced pressure and the position of the 1088 indicator. In one example, the 1088 indicator is in the fully retracted position when the reduced pressure corresponds to an absolute pressure of 125 millimeters of mercury.

With reference now to Figure 15, a process that can be implemented by a reduced pressure treatment system such as the reduced pressure treatment system 200 in Figure 2 is shown according to an illustrative embodiment. The process applies the reduced pressure to a tissue site through a plurality of lumens in an application tube (step 1505). The process stores fluid from the tissue site in at least one collection lumen in the plurality of lumens (step 1510). 0 The process determines a fluid fluid level in at least one collection lumen based on a plurality of markings on the application tube (step 1515).

With reference now to Figure 16, a process that can be implemented by a reduced pressure treatment system such as the reduced pressure treatment system 1000 in Figure 10 is shown according to an illustrative embodiment. The process applies reduced pressure to the tissue site when using a reduced pressure source (step 1605). The process determines whether a reduced pressure limit quantity is present in a

36/36 application or another component of a reduced pressure treatment system (step 1610). If the process determines that a reduced pressure limit quantity is not present, the process moves an indicator to an extended position when using a compressible element. The process then returns to step 1605. Returning to step 1610, if the process determines that a reduced pressure limit quantity is present, the process moves the indicator to the stowed position (step 1620).

The flowcharts and block diagrams in the different described embodiments illustrate the architecture, functionality and operation of some possible implementations of the device and methods. In some alternative embodiments, the function or functions observed in the blocks may occur out of the order observed in the Figures. For example, in some cases, two blocks shown in succession can be substantially executed simultaneously, or the blocks can sometimes be executed in reverse order, depending on the functionality involved.

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