Patent Description:
Clinical studies and practice have shown that providing a reduced pressure in proximity to a tissue site augments and accelerates the growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but application of reduced pressure has been particularly successful in treating wounds. This treatment (frequently referred to in the medical community as "negative pressure wound therapy," "reduced pressure therapy," or "vacuum therapy") provides a number of benefits, including faster healing and increased formulation of granulation tissue. Typically, reduced pressure is applied to tissue through a porous pad or other manifold unit. The porous pad contains cells or pores that are capable of distributing reduced pressure to the tissue and channeling fluids that are drawn from the tissue. The porous pad often is incorporated into a dressing having other components that facilitate treatment.

While existing reduced pressure treatment systems have enjoyed wide commercial and medical success, it would be advantageous to expand the functionality of these systems to provide a more comprehensive treatment regimen.

A need exists, therefore, for an expandable reduced pressure treatment system that allows component modules to be combined with the expandable reduced pressure treatment system and other modules to provide additional treatment features and options. <CIT> discloses a negative pressure treatment system including a recess for receiving a collection canister.

The invention is defined by the independent claim. A selection of optional features of the invention is defined in the dependent claim.

In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific preferred embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical structural, mechanical, and electrical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims.

In the context of this specification, the term "reduced pressure" generally refers to a pressure less than the ambient pressure at a tissue site that is being subjected to treatment. In most cases, this reduced pressure will be less than the atmospheric pressure of the location at which the patient is located. Although the terms "vacuum" and "negative pressure" may be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site may be significantly less than the pressure normally associated with a complete vacuum. Consistent with this nomenclature, an increase in reduced pressure or vacuum pressure refers to a relative reduction of absolute pressure, while a decrease in reduced pressure or vacuum pressure refers to a relative increase of absolute pressure.

<FIG> is a schematic diagram of a reduced pressure treatment system <NUM> according to the present invention. The reduced pressure treatment system <NUM> comprises a dressing <NUM>, which generally includes a manifold unit that is applied to, or within, a tissue site <NUM> for treatment. The dressing <NUM> is fluidly connected to a reduced pressure source <NUM> by a conduit <NUM>. In certain embodiments, the reduced pressure source <NUM> may be integrated with a reduced pressure control unit <NUM>, as described below, and the reduced pressure treatment system <NUM> may also include a canister <NUM> for collecting liquid and other nongaseous exudates extracted from the tissue site.

<FIG> is a block diagram of an exemplary control system <NUM> of the reduced pressure control unit <NUM>. The control system <NUM> includes a treatment controller <NUM> and a graphical user interface (GUI) controller <NUM>. The treatment controller <NUM> may include one or more processors <NUM> that execute software <NUM>. The processor(s) <NUM> may be in communication with a memory <NUM> and input/output (I/O) unit <NUM>. The software <NUM> may be configured to control a number of different operations of the reduced pressure treatment system <NUM>, such as controlling tissue treatment, monitoring sensors and generating alarms and performing communications with systems and devices external to the control unit <NUM> in conjunction with the I/O unit <NUM> and GUI controller <NUM>. It should be understood that the software <NUM> may further be configured to perform different and/or other functions.

The I/O unit <NUM> may enable the control system <NUM> to communicate with external modules, systems, and networks, for example. In one embodiment, the I/O unit <NUM> may operate in conjunction with a controller area network (CAN) or modified CAN, as described further herein. The processor <NUM> may further execute software to receive and process CAN data being received via the I/O unit <NUM>.

A storage unit <NUM>, such as a disk drive or storage medium, may be in communication with the treatment controller <NUM>. Databases 216a-216n (collectively <NUM>) may be used to store treatment or other information. The databases may be configured as relational databases or otherwise. Other information, such as software, may be stored on the storage unit <NUM>.

The GUI controller <NUM> may include one or more processors <NUM> that execute software <NUM>. The software <NUM> may be configured to generate a graphical user interface with which an operator, patient, technician, or other user may interface to control the system <NUM>. The processor <NUM> may be in communication with a memory <NUM>, I/O unit <NUM>, and display driver <NUM>. The memory <NUM> may store current parameters associated with displaying the GUI. For example, if the GUI is being used to display a particular screen shot, the screen shot may be stored in the memory <NUM>. The I/O unit <NUM> may be used to interface with the treatment controller <NUM> and other devices.

A display and touch screen assembly <NUM> may be connected to the GUI controller <NUM> and be used to display the GUI generated by the GUI controller <NUM>. The screen <NUM> enables an operator to merely touch the screen with his or her finger or stylus, as understood in the art, to interface with the GUI. By providing a touch screen, inclusion of a keyboard or keypad may be avoided. However, it should be understood that an external keyboard or keypad may be utilized in accordance with the principles of the present invention. A backlight inverter <NUM> may be connected to the GUI controller <NUM> and screen assembly <NUM>. Alternatively, the backlight inverter <NUM> may be incorporated into the screen assembly <NUM>. In operation, the backlight inverter may enable the screen assembly <NUM> to be inverted for different ambient lighting conditions. For example, a user of the system <NUM> may be treating a patient at night and use backlight inverter <NUM> to selectively turn on the backlight of the screen assembly <NUM> so that he or she can see the GUI better. Alternatively, the backlight inverter may be used to turn the light on the screen assembly <NUM> off at night to allow a patient to sleep in a darker environment.

A speaker <NUM> may be in communication with the GUI controller <NUM>. The speaker may be used to provide sound notification to the user when action is required, or when an alarm condition has occurred.

A unified display interface (UDI) <NUM> may be utilized in accordance with the principles of the present invention. The UDI <NUM> may be used as a digital video interface to assist with video presentation. In addition, a number of communication ports <NUM> may be provided to enable a user to connect external devices to the control system <NUM>. For example, the input ports <NUM> may include a CAN port 236a to enable the control system <NUM> to interface with other treatment systems, memory card port 236b to enable a user to transport data from one device to another, universal serial bus (USB) port to enable an operator to connect devices to the control system <NUM>, such as printers, and Infrared Data Association (IrDA) port 236d to enable a user to interface other devices configured with an IrDA port to the system. It should be understood that other communication ports currently available or available in the future may be utilized in accordance with the principles of the present invention. For example, a communication port for connecting to a local or wide area network may be provided to enable a user to connect the control system <NUM> to a network.

A controller area network is a communication bus that was originally developed for automotive applications in the early <NUM>. The CAN protocol was internationally standardized in <NUM> as ISO <NUM>-<NUM> and includes a data link of the seven layer IOS/OSI reference model. CAN, which is now available from a large number of semiconductor manufacturers in hardware form, provides two communication services: (i) sending a message (data frame transmission) and (ii) requesting a message (remote transmission request, RTR). All other services, such as error signaling and automatic re-transmission of erroneous frames, are user-transparent, which means that the CAN circuitry automatically performs these services without the need for specific programming.

A CAN controller is comparable to a printer or typewriter. Language, grammar, and vocabulary is defined for a particular use. CAN provides a multi-master hierarchy that allows for building of intelligent and redundant systems. The use of CAN with the tissue treatment system enables additional component modules, as described further herein, to operate in conjunction with the system. The component modules may operate as nodes, where each node on the CAN receives messages and decides whether a message is relevant. Data integrity is maintained because all devices in the system receive the same information. CAN also provides sophisticated error detection mechanisms and re-transmission of faulty messages.

In one embodiment, the language, grammar, and vocabulary may be customized for the system so that only devices that have the same language, grammar, and vocabulary can communicate with the system. By operating with such a customized or proprietary system, control over the quality of modules and devices that interface with the system may be maintained.

Referring still to <FIG>, in operation, the communication ports <NUM> may be utilized to enable users to import or export data to and from the control system <NUM>. For example, patient information, treatment information, and images associated with patient wounds may be communicated over a communication port <NUM>. Other information, including software updates, may be communicated over one or more communication ports <NUM>.

A lithium-ion (Li-Ion) battery <NUM> and DC socket <NUM> may be connected to the therapy controller <NUM>. An external adapter (not shown) may be connected to a wall socket (not shown) to convert AC power to DC power for supplying DC power to the treatment controller <NUM> and other electrical components within the control system <NUM>. If the external power should fail, then the Li-Ion battery <NUM> powers the control system <NUM>. Alternatively, should the control system <NUM> be used in a location without power or be used in reliance on battery power, the Li-Ion battery <NUM> provides power to the control system <NUM>.

A manifold controller <NUM> may be connected to the treatment controller <NUM> and be used to control various devices of the dressing <NUM> and receive feedback information from sensors disposed on the dressing <NUM>. The manifold controller <NUM> may communicate with the treatment controller <NUM> while performing treatment. The manifold controller <NUM> may include analog and digital circuitry (not shown) for communicating with the various devices on the dressing <NUM>. In one embodiment, the manifold controller <NUM> may include one or more digital-to-analog (D/A) and analog-to-digital (A/D) converters (not shown) to enable digital and analog signals to be passed between the various devices (e.g., sensors) on the dressing <NUM>. Still yet, one or more amplifiers (not shown) may be included with the manifold controller <NUM>.

As shown, a number of transducers (i.e., sensors) and devices may be connected to the manifold controller <NUM>. A reduced pressure source, such as a vacuum pump <NUM>, may be connected to the manifold controller <NUM>. A valve <NUM> and pump valve <NUM> may be connected to the manifold controller <NUM> and used to control air being moved within the manifold unit. A number of sensors may also be connected to the manifold controller <NUM>, including a flow sensor <NUM>, ambient pressure sensor <NUM>, feedback pressure sensor <NUM>, and pump pressure sensor <NUM>. These sensors may be conventional airflow and pressure sensors as understood in the art. A canister release button LED <NUM> may also be connected to the manifold controller <NUM>.

In operation, the manifold controller <NUM> may communicate signals between the treatment controller <NUM> and devices coupled to the dressing <NUM>. In communicating the signals, the manifold controller <NUM> may condition the signals by converting the signals between analog and digital signals, amplify signals and amplify drive signals for the vacuum pump <NUM> and valves <NUM> and <NUM>. In one embodiment, the manifold controller <NUM> includes a processor (not shown) to perform local processing and control to offload some of the processing and control the processor <NUM> of the treatment controller <NUM>.

<FIG> is a front perspective view of one embodiment of a control unit <NUM> that houses the control system <NUM>. As <FIG> illustrates, the control unit <NUM> includes a housing <NUM> having a shoulder <NUM> and an extension <NUM>. The extension <NUM> includes an end surface <NUM>, a first ridge <NUM>, and a second ridge <NUM>. The second ridge is generally located on the end surface <NUM> substantially opposite the first ridge <NUM>. The general steps of the control unit <NUM> illustrated in <FIG> is an elliptic cylinder, but any geometric configuration that provides sufficient interior capacity for the control system <NUM> and the reduced pressure source <NUM> is acceptable. The extension <NUM> includes an aperture <NUM>, through which the CAN port 236a is exposed to the exterior of the end surface <NUM>.

<FIG> is an enlarged partial cross-section view of a control unit similar to the control unit <NUM> along line <NUM>-<NUM>. In particular, <FIG> illustrates a partial housing <NUM> having a shoulder <NUM> and an extension <NUM>. The extension <NUM> includes an end surface <NUM>, a first ridge <NUM>, and a second ridge <NUM> substantially opposite the first ridge <NUM>. An aperture <NUM> extends from the exterior of the end surface <NUM> to the interior of the housing <NUM>.

<FIG> is an enlarged partial cross-section view of a control unit similar to the control unit <NUM> along line <NUM>-<NUM>. In particular, <FIG> illustrates a partial housing <NUM> having a shoulder <NUM> and an extension <NUM> with an end surface <NUM>.

In any embodiment of the control unit, the housing may be manufactured as separate components and subsequently assembled, or may be manufactured as a single unit.

<FIG> is a perspective view of a first end of an embodiment of a component module <NUM>. The component module <NUM> may include a variety of equipment that is useful for tissue treatment, including without limitation a wound camera, cyclic/next generation skin stretching, capacitive volume and wound contour mapping, wound bed pH monitoring, wound warming/climate control, wound moisture and temperature monitoring, electrical stimulation, UV therapy, and wound healing marker measurement. The component module <NUM> typically includes a control system similar to the control system <NUM> described above. In particular, the component module <NUM> includes a CAN controller (not shown) and a CAN port (see <FIG>). The component module <NUM> also includes a CAN plug <NUM>, which protrudes through an aperture <NUM> and interfaces with the CAN port 236a of the control system <NUM>. As <FIG> illustrates, the component module <NUM> includes a housing <NUM> having a rim <NUM>, a recessed end surface <NUM>, and notches <NUM>. The component module <NUM> further includes a mounting assembly <NUM> fixed to the recessed end surface <NUM>. The mounting assembly <NUM> includes a first latch <NUM> and a second latch <NUM> that are positioned within the notches <NUM>. The first latch and the second latch each have a fastener bar <NUM> that is substantially flush with the rim <NUM> in the configuration illustrated in <FIG>. The fastener bars <NUM> are configured to overlap the ridges on other modules or on a control unit, such as ridges <NUM> and <NUM> illustrated in <FIG>.

<FIG> is a perspective view of a second end of the component module <NUM> illustrated in <FIG>. This perspective view illustrates a configuration that is substantially similar to the configuration of the control unit <NUM> described above with reference to <FIG>, so that additional component modules may be connected in a chain or series as needed to expand the functionality of a reduced pressure treatment system. In particular, the component module <NUM> includes the outer surface <NUM> having a shoulder <NUM>, an extension <NUM> fixed to the shoulder, and an end surface <NUM>. The extension <NUM> further includes a first ridge <NUM> and a second ridge <NUM>, which is generally located opposite the first ridge <NUM>, and an aperture <NUM>, through which a CAN port may be exposed to the exterior of the end surface <NUM>.

Referring to <FIG> for illustration, the first latch <NUM> and the second latch <NUM> may be extended to mount the component module <NUM> to a control unit or another component module. In alternate embodiments, the first latch <NUM>, the second latch <NUM>, or both may be rotated about a pin so that only the fastener bar of the latch is extended. Extending the mounting assembly <NUM> allows the fastener bars <NUM> to be placed over the ridges on another component module or control unit, and then collapsed onto the extension to secure the component module <NUM>.

<FIG> illustrates the second end of the component module <NUM> shown in <FIG>, with the first latch <NUM> extended.

Claim 1:
An apparatus for use in a reduced-pressure treatment system (<NUM>), the apparatus comprising a control unit (<NUM>) and a component module, the control unit (<NUM>) comprising:
a housing (<NUM>);
a communication controller disposed in the housing (<NUM>);
characterised by an extension (<NUM>) coupled to the housing (<NUM>) and having an end surface (<NUM>), the extension (<NUM>) engaging with the component module (<NUM>); and
a controller area network (CAN) port (236a) coupled to the communication controller and exposed through a first aperture (<NUM>) in the end surface (<NUM>);
a first ridge (<NUM>) located on the end surface (<NUM>); and
a second ridge (<NUM>) located on the end surface (<NUM>) opposite the first ridge (<NUM>); and further characterised by the component module (<NUM>) comprising:
a module housing (<NUM>) having a rim (<NUM>), a recessed end surface (<NUM>), and an extension;
a mounting assembly (<NUM>) fixed to the recessed end surface (<NUM>), the mounting assembly (<NUM>) comprising:
a first latch (<NUM>) positioned in a first notch (<NUM>), and
a second latch (<NUM>) positioned in a second notch (<NUM>),
wherein the first latch (<NUM>) and the second latch (<NUM>) each comprise a fastener bar (<NUM>) that is substantially flush with the rim (<NUM>) when the first latch (<NUM>) and the second latch (<NUM>) are not extended,
wherein the fastener bar (<NUM>) of the first latch (<NUM>) overlaps the first ridge (<NUM>) and the fastener bar (<NUM>) of the second latch (<NUM>) overlaps the second ridge (<NUM>) to secure the component module (<NUM>) to the control unit (<NUM>);
a control system (<NUM>) contained within the module housing (<NUM>), the control system (<NUM>) having a module communication controller configured to communicate with the communication controller of the control unit (<NUM>);
a CAN plug (<NUM>) coupled to the module communication controller and extending through a first aperture in the recessed end surface (<NUM>) and interfacing with the CAN port (236a); and
a communication port coupled to the module communication controller and exposed to a second aperture extending through the extension.