HK1155985A - Manually-actuated, reduced-pressure systems for treating wounds - Google Patents

Abstract

A manually-actuated, constant reduced-pressure apparatus for use with a reduced- pressure system (100) for treating tissue at a tissue site (102) includes a flexible, collapsible member (146) that is operable to move between a compressed position and an extended position. The collapsible member may be disposed between a carrier member (156) and a slider member (168) that move between a compressed position and an extended position. The carrier member and slider member are urged away from each other by a constant-force biasing member, e.g., a constant force coil spring. As the apparatus moves from the compressed position to the extended position, a constant reduced-pressure is generated and delivered to a reduced-pressure port (154). Systems, methods of manufacturing a manually-actuated, constant reduced-pressure apparatus, and methods of treating a tissue site are also provided.

Description

Manually actuated reduced-pressure system for treating wounds

Cross Reference to Related Applications

The present invention is in accordance with the benefit of 35U.S. C. § 119(e) U.S. provisional patent application Ser. No. 61/079,866 entitled "Manual-activated, Reduced-Pressure System for Treating a Wund", filed 11.7.2008, this application being incorporated herein by reference for all purposes.

Background

The present invention relates generally to medical treatment systems, and in particular to manually-actuated reduced-pressure systems and devices for treating wounds.

Clinical studies and practice have shown that providing reduced pressure proximate to a tissue site enhances and accelerates the growth of new tissue at the tissue site. The use of this phenomenon is numerous, but the use of reduced pressure has been particularly successful in treating wounds. This treatment (often 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 formation of granulation tissue. Typically, reduced pressure is applied to tissue through a porous pad or other manifold device. The porous pad contains cells or pores that are capable of distributing reduced pressure to the tissue and directing fluids drawn from the tissue. The porous pad may be incorporated into a dressing (dressing) with other components to aid in treatment.

Reduced pressure treatment systems are often applied to large, highly exuding wounds present in patients undergoing urgent or long-term care, as well as other severe wounds that do not readily heal without the application of reduced pressure. Low severity wounds that are less bulky and produce less exudate have generally been treated with dressings without reduced pressure. The need and expense of trained caregivers who apply and maintain reduced pressure systems has been detrimental to use. At the same time, size and power requirements have been detrimental to many patients desiring flexibility and comfort. Further, the expense of the system has made the use of reduced pressure on low severity wounds difficult.

One of the challenges in treating wounds with reduced pressure is providing an effective way to generate a constant reduced pressure source. Currently, battery-powered pumps (battery-operated pumps) are often used to provide reduced pressure to a wound site. However, these pumps are expensive and require maintenance to ensure that the battery is not running out of power while the wound therapy is in progress. Due to the time involved in replacing the battery or making other supplies, a loss of battery power may occur over a long period of time until the reduced pressure is reused in the site. Furthermore, if the reduced pressure at the site is not properly maintained, leaks may occur at the wound site, thereby limiting the effectiveness of the reduced pressure therapy.

SUMMARY

The systems, devices, and methods of the illustrative embodiments described herein solve the problems of existing reduced pressure sources and systems. According to an illustrative embodiment, a manually-actuated reduced-pressure system for treating a wound on a patient includes: a manifold member, a sealing member, a reduced-pressure delivery member, a reduced-pressure interface, and a manually-actuated constant reduced-pressure source for generating a reduced pressure. The manifold is operable to distribute reduced pressure. The sealing member is operable to provide a fluid seal over the manifold member and a portion of the patient. The reduced-pressure delivery member transmits reduced pressure from the manually-actuated constant reduced-pressure source to the reduced-pressure interface. A manually-actuated constant reduced pressure source includes a reduced pressure port fluidly coupled to a first end of a reduced pressure delivery member. The manually-actuated constant reduced pressure source includes a constant-force biasing member.

According to another illustrative embodiment, a manually-actuated reduced-pressure apparatus for use on a reduced-pressure system for treating tissue includes a flexible, collapsible member having a first end, a second end, and an interior space. The flexible and foldable member is operable to move between a compressed position and an extended position. The manually-actuated pressure relief device also includes an evacuation port coupled to the flexible, collapsible member and a pressure relief port coupled to the flexible, collapsible member. A manually-actuated pressure relief device has a carrier member coupled to a first end of a flexible, foldable member and a slider member coupled to a second end of the flexible, foldable member. The slider member is operable to slidably engage the carrier member and move between a compressed position and an extended position. The manually actuated pressure relief device also includes a constant force biasing member associated with the carrier member and the slider member and operable to drive the slider member and the carrier member away from each other between the compressed position and the extended position.

According to another illustrative embodiment, a method of manufacturing a manually actuated pressure relief device includes the steps of: the method includes forming a carrier member, forming a slider member, and providing a flexible, collapsible member having a first end, a second end, and an interior space. The slider member and the carrier member are formed to slidably engage with each other. The flexible and foldable member is movable between a compressed position and an extended position. The method of manufacture further comprises the steps of: the method includes coupling a first end of a flexible, foldable member to a carrier member, coupling a second end of the flexible, foldable member to a slider member, and associating a constant force displacement member with the carrier member and the slider member. The constant force biasing member is operable to drive the carrier member and the slider member away from each other between the compressed position and the extended position. The method of manufacture further comprises the steps of: associating a vent with the flexible, foldable member to allow fluid to exit an interior space of the flexible, foldable member when placed in a compressed position, and associating a reduced-pressure port with the flexible, foldable member to convey reduced pressure from the flexible, foldable member.

According to another illustrative embodiment, a method of treating a tissue site on a patient with reduced pressure includes the steps of: the method includes disposing a manifold member proximate to a tissue site, disposing a sealing member over the manifold member and a portion of a patient's epidermis to form a fluid seal, coupling a reduced-pressure interface over the sealing member to provide reduced pressure to the manifold member, and providing a reduced-pressure source, wherein the reduced-pressure source is a manually-actuated constant reduced-pressure source. The manually-actuated constant reduced pressure source includes a reduced pressure port. The reduced-pressure port is fluidly coupled to the first end of the reduced-pressure delivery member and is operable to generate a substantially constant reduced pressure. A manually actuated constant reduced pressure source includes a constant force biasing member. The method of treatment further comprises the steps of: fluidly coupling the reduced-pressure source to the reduced-pressure interface and moving the reduced-pressure source to the compressed position.

Other features and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follow.

Brief Description of Drawings

Figure 1 is a schematic view, partially in cross-section and partially in perspective, of an illustrative embodiment of a manually-actuated, reduced-pressure system for treating a wound;

FIG. 2 is a schematic exploded perspective view of an illustrative embodiment of a manually-actuated pressure relief device for use on a pressure relief system;

FIGS. 3A and 3B are schematic cross-sections of a portion of the device of FIG. 2;

4A, 4B, and 4C represent illustrative embodiments of a manually actuated pressure relief device shown in a compressed position, an intermediate position, and an expanded position, respectively;

FIG. 5 is a schematic perspective view of another illustrative embodiment of a manually-actuated pressure relief device; and

fig. 6 is a schematic perspective view of another illustrative embodiment of a manually-actuated pressure relief device.

Detailed description of illustrative embodiments

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

Referring to fig. 1, a manually-actuated reduced-pressure system 100 for treating a tissue site 102 with reduced pressure is shown. The tissue site 102 may be body tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue.

Reduced pressure may be applied to the tissue site 102 to help promote the removal of exudate or other fluids from the tissue site or to stimulate the growth of additional tissue. As used herein, "or" does not require mutual exclusivity unless otherwise indicated. In the case of a wound at the tissue site 102, the growth of granulation tissue and removal of exudates and bacteria help promote healing of the wound. In the case of non-wounded or defect-free tissue, reduced pressure may be used to promote the growth of tissue that may be harvested and transplanted to another tissue site. As used herein, "reduced pressure" generally refers to a pressure that is less than the ambient pressure at the tissue site being subjected to treatment. In most cases, this reduced pressure will be less than the atmospheric pressure at which the patient is located. Alternatively, the reduced pressure may be less than the hydrostatic pressure at the tissue site 102. Unless otherwise indicated, the values of pressure stated herein are gauge pressures. Although the terms "vacuum" and "negative pressure" may be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site may be greater than the pressure typically associated with a complete vacuum. Consistent with the use herein, an increase in reduced or vacuum pressure generally refers to a relative decrease in absolute pressure.

The manually-actuated reduced-pressure system 100 includes a manifold member 110, a sealing member 114, a reduced-pressure interface 120, and a reduced-pressure source 140 that is a manually-actuated reduced-pressure device. The reduced-pressure delivery member 122 fluidly couples the reduced-pressure source 140 to the reduced-pressure interface 120.

The manifold member 110 is positioned at the tissue site 102. The manifold member 110 may be a biocompatible material that can be placed in contact with the tissue site and distribute reduced pressure to the tissue site. The term "manifold" as used herein generally refers to a substance or structure provided to assist in applying reduced pressure to, delivering fluids to, or removing fluids from a tissue site. The manifold member 110 generally includes a plurality of flow channels or pathways that distribute fluid provided to and removed from the area of tissue surrounding the manifold. The flow channels may be interconnected. Examples of manifolds may include, but are not limited to: tools having structural elements configured to form flow channels, cellular foams (e.g., open cell foams), porous tissue aggregates, and liquids, gels, and foams that include or cure to include flow channels. The manifold member 110 may be porous and may be made of foam, mesh, felted mat, or any other material suitable for a particular biological application.

In an illustrative embodiment, the manifold member 110 is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be a polyurethane open cell reticulated foam, such as the GranuFoam manufactured by Kinetic conjugates, Incorporated of san antonio, texasA material. Other embodiments may include "closing the air holes. In some cases, the manifold may also be used to dispense fluids, such as drugs, antimicrobial agents, growth factors, and other solutions, to the wound. Other layers may be included, such as absorbent materials, wicking materials, hydrophobic materials, and hydrophilic materials.

The sealing member 114 is disposed on the manifold member 110 and provides a fluid seal sufficient for the manually-actuated reduced-pressure system 100 to maintain reduced pressure at the tissue site 102. By "fluid seal" or "seal" is meant a seal sufficient to maintain reduced pressure at a desired location for the particular reduced-pressure subsystem or source involved. The sealing member 114 may be a cover for securing the manifold member 110 at the tissue site 102. While the sealing member 114 may be impermeable or semi-permeable, the sealing member is capable of maintaining a reduced pressure at the tissue site 102 after installation of the sealing member 114 over the manifold member 110 and a portion of the patient's epidermis. The sealing member 114 may be a flexible over-drape (over-drape) or a film formed from silicone based compounds (acrylics), polyurethanes, hydrogels, or materials formed from hydrogels, or any other biocompatible material that includes the desired impermeability or permeability characteristics for the tissue site 102.

The sealing member 114 may also include attachment means 116 to secure the sealing member 114 to the skin of the patient. The attachment tool 116 may take many forms. For example, the adhesive layer 118 may be disposed along the perimeter of the sealing member or any portion of the sealing member to provide a fluid seal. The adhesive layer 118 may also be pre-applied and covered with a release member (release member) that is removed upon application.

The reduced-pressure interface 120 or connector allows the passage of fluids from the manifold member 110 to the reduced-pressure delivery member 122, and vice versa. For example, exudate collected from a tissue site using the manifold member 110 may pass through the reduced-pressure interface 120 into the reduced-pressure delivery member 122. In another embodiment, the system 100 may not include the reduced-pressure interface 120, and the reduced-pressure delivery member 122 may be inserted directly through the sealing member 114 and into the manifold member 110. The reduced pressure delivery member 122 may be a medical tube or tubing or any other means for enabling the transport or delivery of reduced pressure.

The reduced pressure is generated by a reduced pressure source 140 and supplied to the reduced pressure delivery member 122, the reduced pressure source 140 being a manually-actuated reduced pressure device. The reduced-pressure source 140 may include a flexible, collapsible member 146 associated with the carrier member 156 and the slider member 168. As used herein, "associated" means bringing together or bringing into relationship any of a variety of ways, such as permanently coupling one to another, releasably coupling one to another, aligning members to allow one member to push or pull another member, and the like.

Although not explicitly shown in fig. 1, the reduced-pressure source 140 includes a constant-force biasing member that drives the slider member 168 away from the carrier member 156. The reduced-pressure source 140 has a vent 153, the vent 153 allowing air or other fluid in the flexible collapsible member 146 to exit without entering the vent 153. The reduced pressure is transmitted by the reduced-pressure source 140 through the reduced-pressure port 154, the reduced-pressure port 154 being coupled to the reduced-pressure delivery member 122 and operable to allow flow in only one direction, from the reduced-pressure delivery member 122 into the flexible, collapsible member 146. The reduced-pressure source 140 is operable to generate a constant reduced pressure using a constant-force biasing member. As used herein, "constant" means that a particular reduced pressure may be maintained at the reduced-pressure port 154 at a given level of plus or minus five percent. The strength of the constant force deflection member is a variable used to establish the level of reduced pressure generated by reduced pressure source 140.

Many different tools may be added to the central portion 124 of the reduced pressure delivery member 122. For example, a fluid collection member 126 may be added to contain the removed exudate and other fluids (fluids may also be retained within the flexible, collapsible member 146). Other examples of tools that may be included on the central portion 124 of the reduced pressure delivery member 122 include pressure feedback tools, volume detection systems, blood detection systems, infection detection systems, flow monitoring systems, temperature monitoring systems, and the like. Some of these tools, such as the fluid collection member, may be integrally formed with the reduced-pressure source 140. The reduced-pressure port 154 may include a filter member that includes one or more filters and may include a hydrophobic filter that prevents liquid from entering the interior space within the collapsible member 146. An odor filter may also be included.

In operation, the manifold member 110 is disposed proximate the tissue site 102 and the sealing member 114 is disposed to create a fluid seal over the manifold member 110 and a portion of the patient's epidermis. If not already coupled, the reduced-pressure interface 120 is coupled to the sealing member 114. The reduced-pressure delivery member 122 is coupled between the reduced-pressure interface 120 and the reduced-pressure source 140. The slider member 168 is manually actuated or moved toward the carrier member 156, thereby folding the flexible foldable member 146 and placing the reduced-pressure source 140 in the compressed position. During this movement, air or other fluid in the interior space of the flexible and collapsible member 146 is forced out through the outlet vent 153. Then, once released, as the deflection tool drives the slider member 168 away from the carrier member 156, the deflection forces the flexible, collapsible member 146 toward expansion, which creates a reduced pressure that communicates through the reduced-pressure port 154 to the reduced-pressure delivery member 122 and through the reduced-pressure interface 120 to the manifold member 110 and to the tissue site 102. Because the delivery of reduced pressure causes gas or possibly other fluids to enter the reduced-pressure port 154, the flexible, collapsible member 146 expands and eventually fills to reach the expanded position. Depending on the circumstances, for example, if the flexible foldable member 146 is not contaminated, the (re-prime) flexible foldable member 146 may be reinitialized by placing the flexible foldable member 146 again in the compressed position and starting another cycle. An alarm may be incorporated to emit an audible signal when the inflated position has been reached.

Referring now primarily to FIG. 2, a manually-actuated reduced-pressure source 240 is shown in an exploded perspective view. The manually-actuated reduced-pressure source 240 includes a flexible, collapsible member 246 that is positioned between a carrier member 256 and a slider member 268. The carrier member 256 and the slider member 268 are driven away from each other by the constant force biasing member 278.

The flexible and foldable member 246 has a first end 248 and a second end 250. The flexible, collapsible member 246 may contain air or other fluid in the interior portion. A vent 253 may be located near the first end 248 to allow air or other fluid to exit the interior space of the flexible, collapsible member 246. The reduced-pressure port 254 may be located near the second end 250. During use, the reduced-pressure port 254 is fluidly coupled to a reduced-pressure delivery conduit, such as the reduced-pressure delivery member 122 of fig. 1, to provide reduced pressure to a system for treating tissue at a wound site. These ports 253, 254 can be located anywhere on the flexible and foldable member 246.

In the illustrative embodiment, a nub (node) 255 is coupled to flexible foldable member 246 near second end 250. Nodules 255 are added for safety reasons. In particular, because the first end 248 has one evacuation opening 253 and the second end 250 has a relief opening 254 and nubs 255, the flexible foldable member 246 can only mate with the carrier member 256 and the slider member 268 in one orientation. Thus, the flexible and foldable member 246 can only be mounted in the correct manner.

In one illustrative embodiment, the flexible and foldable member 246 may be formed as a bellows. In such illustrative embodiments, flexible and foldable member 246 is formed to have corrugated side walls 245, corrugated side walls 245 having corrugations that can move toward and away from each other, resulting in compression and expansion of the compressible bellows. The flexible and foldable member 246 may be made of any material that allows for compression and expansion of the bellows, such as a flexible polymer. The shape may be rectangular, circular, or any other shape. The flexible and foldable member 246 may be coupled to the carrier member 256 and the slider member 268 by welding, screwing, bonding, bolting, air-lock sealed, push button connection, or by any other means. The term "coupled" generally includes coupling through a separate object and includes direct coupling. The term "coupled" also includes two or more components that are continuous with each other by virtue of each of the components being formed from the same piece of material. Furthermore, the term "coupled" may include chemical, such as by chemical bonding, mechanical, thermal, or electrical coupling.

The inner chamber of the flexible and foldable member operates as a closed system such that the pressure and volume have a defined relationship, i.e. P₁*V₁＝P₂*V₂. The area of the end wall 251 of the flexible, collapsible member 246 experiences pressure and transmits force to the slider member 268. The force is proportional to the area (F ≈ PA). The resulting reduced pressure may be controlled by selecting the force of the constant force biasing member 278 and controlling the area of the end wall 251. The pressure generated by manually-actuated reduced-pressure source 240 is substantially inversely proportional (P ≈ F/A) to the area on the interior portion of flexible foldable member 246 facing end wall 251 of slider transverse slider member 276.

Carrier member 256 is shown in this illustrative embodiment as having a first socket member 258 and a second socket member 260. As will be explained further below, the socket members 258 and 260 are sized to receive a first constant force coil spring 280 and a second constant force coil spring 282, respectively, and to receive a first arm 270 and a second arm 272, respectively, of the slider member 268.

The first 258 and second 260 socket members are coupled by a transverse carrier member 262. The transverse carrier member 262 is formed with a mouth passage 264. The port channel 264 is sized and configured to securely receive the drain port 253, such as by an interference fit. The socket members 258 and 260 may be formed with indicator windows 266 through which graduations, markings or other visible markings 274 on the exterior surface 273 of the slider member 268 may be viewed. The carrier member 256 may be formed as multiple pieces coupled by welding, adhesives, bolting, snap fitting, screwing, or by any other coupling, or may be formed as an integral unit, such as by casting. The two coil springs 280, 282 may be disposed in a single socket member; in this case, it may be desirable to place the indicator window on the side opposite the side with the spring.

Slider member 268 is formed having a first arm 270 and a second arm 272 and having a transverse slider member 276 coupled between arms 270, 272. Transverse slider member 276 has a first port channel 275 and a second port channel 277, the first port channel 275 and the second port channel 277 being sized and configured to securely receive the relief port 254 and the nub 255 (or simulated port), respectively, such as with an interference fit. A visible marking 274, such as a scale, may be disposed on one of the arms, such as the exterior surface 273 of the second arm 272.

In the present illustrative embodiment, the constant force biasing member 278 includes a first constant force coil spring 280 and a second constant force coil spring 282. The first constant force coil spring 280 has a fixed portion 284 and a coil portion (coil portion) 286. The securing portion 284 is coupled proximate to the socket opening 259 of the first socket member 258, and the socket opening 259 is sized to receive the coil portion 286 of the first constant force coil spring 280. The first arm 270 of the slider member 268 is formed with an interface region 271 or member that may be concave as shown, and which is configured to contact the spiral portion 286 and deploy the spiral portion 286 or deflect the spiral portion 286 upon manual actuation of the slider member 268 toward the carrier member 256.

Referring now primarily to fig. 3A and 3B, the schematic cross-sections of the first socket member 258, the first constant force coil spring 280 and the first arm 270 are first shown in an extended position in fig. 3A and then in a compressed position in fig. 3B. Beginning with the extended position of fig. 3A, the helical portion 286 approaches its natural free position or length. The fixed portion 284 of the first constant force coil spring 280 is coupled using a coupling tool 283 such as a spring retainer or pin. As the first arm 270 is driven into the first socket member 258, the interface region 271 presses against the coil portion 286 of the first constant force coil spring 280 and at least partially uncoils the coil portion 286, and throughout the first constant force coil spring 280 provides a constant force against the load placed on the first constant force coil spring 280.

When the first arm 270 is driven toward its stop point as shown in fig. 3B and released, the first constant force coil spring 280 will continue to drive the first arm 270 away from the first socket member 258 and away from the first socket member 258. Returning again to fig. 2, it will be appreciated that the second constant force coil spring 282 interacts with the second socket member 260 and the second arm 272 in a manner similar to that shown for the first constant force coil spring 280 in fig. 3A and 3B.

In operation, the manually-actuated reduced pressure source 240 generates reduced pressure when the manually-actuated reduced pressure source 240 moves from the compressed position shown in fig. 4A to the intermediate position shown in fig. 4B and ends in the extended position shown in fig. 4C. To prepare the manually-actuated reduced-pressure source 240 for use in a reduced-pressure treatment system, the flexible, collapsible member 246 is positioned with the drain 253 in the port channel 264 of the carrier member 256, and the reduced-pressure port 254 and the nub 255 are positioned in the first port channel 275 and the second port channel 277, respectively. The reduced-pressure delivery conduit may be connected to the reduced-pressure port 254. The slider member 268 is then driven toward the carrier member 256 by, for example, manually squeezing or activating the members together, such as by the hand of a user. When this is done, the constant force coil springs 280 and 282 are uncoiled (unspind) and the manually actuated reduced pressure source 240 reaches the compressed position (see fig. 3B and 4A).

The applied manual force is then removed and the springs 280 and 282 drive the slider member 268 away from the carrier member 256. The actuation begins to inflate the flexible, collapsible member 246 and this sets suction on the relief port 254. When gas or other fluid is received into the reduced-pressure port 254, the manually-actuated reduced-pressure source 240 again reaches equilibrium, at least to some extent, as the slider member 268 is removed from the carrier member. This process continues past the intermediate position until the manually-actuated reduced-pressure source 240 reaches a final or extended position (see fig. 3A and 4C) in which the flexible, collapsible member 246 is fully filled or the springs 280, 282 have reached their starting positions.

Referring now primarily to FIG. 5, another illustrative embodiment of a manually actuated constant reduced pressure source 340 is shown. The manually-actuated constant reduced pressure source 340 includes a flexible, collapsible member 346, a carrier member 356, and a slider member 368. A retention member 383 couples a constant force biasing member (not shown) within a portion of the carrier member 356. The constant force biasing member provides a force that drives the slider member 368 away from the carrier member 356 as the manually actuated constant reduced pressure source 340 moves from the compressed position to the extended position.

Carrier member 356 includes a first socket member 358, a second socket member 360 and a transverse carrier member 362. The carrier member 356 may be formed of coupled components or may be formed as an integral unit, such as by casting. An indicator 365 may be included as part of the manually actuated constant reduced pressure source 340 to indicate remaining capacity or movement. As one example, the indicator 365 may be an indicator window 366 formed on the first or second socket members 358, 360, the indicator window 366 allowing a visible mark attached to a portion of the slider member 368 to be seen and thereby providing an indication of the amount the manually-actuated constant reduced pressure source 340 may be moved further before reaching its fully extended position. An orifice channel 364 may be formed on the transverse carrier member 362 to help maintain an orifice, such as a reduced pressure orifice, through which reduced pressure generated within the flexible foldable member 346 may be delivered to the reduced-pressure delivery conduit 322, which delivers the reduced pressure to a system for treating tissue at a wound site.

The slider member 368 has a first arm 370 and a second arm 372. The arms 370, 372 are connected by a transverse slider member 376. The lateral slider member 376 may be pressed into position on both arms 370, 372. In a manner similar to that shown in fig. 3A and 3B, arms 370, 372 may push on a constant force biasing member located within socket members 358 and 360.

The flexible foldable member 346 has a first end 348 and a second end 350. A portion of the second end 350 can be formed to contain fluid as intended, such as exudate that can collect within the interior space of the flexible foldable member 346. An absorbent gel or other absorbent material may be disposed within an interior portion of the foldable member, such as proximate the second end 350. In this particular illustrative embodiment, first end 348 of flexible and foldable member 346 includes a pressure relief port that fits within port channel 364 on carrier member 356. A fit, such as an interference fit, may be sufficiently tight to help securely retain first end 348 to carrier member 356, or other means of coupling first end 348 may be utilized, such as fasteners, welding, adhesives, and the like. The second end 350 of the flexible foldable member 346 is formed with a channel or slot or carrier flange 352, the channel or slot or carrier flange 352 being sized and configured to receive the lateral slider member 376 and thereby secure the second end 350 to the slider member 368.

Referring now primarily to fig. 6, another illustrative embodiment of a manually-actuated pressure relief device 440 is shown in an exploded perspective view. The manually-actuated pressure relief device 440 includes a flexible, collapsible member 446, a carrier member 456, and a base member 461, the carrier member 456 including a housing portion 457 or shell. The manually-actuated pressure relief device 440 also includes a slider member 468 and a constant force biasing member 478.

The flexible and foldable member 446 has a first end 448 and a second end 450. In this embodiment, the first end 448 is coupled inside the slider member 468 and the second end 450 is coupled to a base foot (base pod)463 of the base member 461.

The housing portion 457 or the housing of the carrier member 456 is pressed into position with the base member 461 to form an integral unit, and this can be done using both the lip portion 490 and a snap fit (detent) or snap fit arm (detent arm)467 that engages the housing portion 457. The snap arms 467 may be used to engage and accommodate a portion of the housing portion 457, and the lip portion 490 may be included to receive and accommodate the housing portion 457 proximate to the opening 492. The housing portion 457 may include a slider opening 465, in which the slider member 468 may be slidably coupled and may be manually depressed within the slider opening 465.

The base member 461 may include a reduced-pressure port (not shown) similar to the reduced-pressure port 254 of fig. 2 for allowing a delivery conduit to be attached and to receive and transmit reduced pressure. The pressure relief port 254 is fluidly coupled to the interior space of the flexible, collapsible member 446. The pressure relief port 254 may include a counter-bore into the flexible, collapsible member 446 and preferably into a portion of the flexible, collapsible member 446 used to hold any fluids that may enter. The port may further include a filter carrier having a filter member; the filter member may include a charcoal pellet filter and a sintered hydrophobic filter.

The slider member 468 is formed to have an opening 469. The slider member 468 is sized and operable to slide within a portion of the housing portion 457.

The constant force biasing member 478 may be a constant force coil spring 480 having a fixed portion 484 and a coil portion 486. The central opening of the spiral portion 486 may be placed on a barrel or needle 488 located on the housing portion 457. The securing portion 484 may be secured proximate the slider opening 469.

Upon final assembly of manually-actuated pressure relief device 440, flexible foldable member 446 is coupled to base foot 463 where it will be held stationary and at base foot 463, flexible foldable member 446 is placed in fluid contact with the pressure relief port. The first end 448 of the flexible, foldable member 446 is disposed within the opening 469 of the slider member 468 and is coupled to a portion of the slider member 468. The housing portion 457 is placed over the slider member 468 and the flexible, collapsible member 446 is depressed until the snap-in arms 467 engage corresponding receptacles within the openings 492 of the housing portion 457 and the lip 490 engages the openings 492. A constant force biasing member 478, such as a constant force coil spring 480, is coupled to the device 440 by placing a central opening of the coil portion 486 on the barrel 488 of the carrier member 456 and coupling the securing portion 484 proximate to the opening 469 of the slider member 468.

In operation, the reduced-pressure delivery conduit is attached to the reduced-pressure port on the base member 461, and then the slider member 468 can be depressed or manually actuated by further pushing the slider member 468 down into the slider opening 465 to return the manually-actuated pressure relief device 440 to a compressed position in which the flexible, collapsible member 446 is folded. When the flexible foldable member 446 is folded, air or other fluid within the manually-actuated pressure relief device 440 is forced out of the drain, which may also be on the bottom side of the base member 461 (similar to the drain 253 of fig. 2).

As the coil spring 480 drives the slider member 468 away from the base member 461 of the carrier member 456, a reduced pressure is created within the interior space of the flexible, collapsible member 446. The reduced pressure is communicated with the reduced pressure port. Thus, a constant reduced pressure is supplied until the flexible, collapsible member 446 is filled with air or other fluid, or until the rest position or free length of the constant force coil spring 480 is reached. The device provides a constant reduced pressure with only small variations. Over a period of time, the manually-actuated pressure relief device 440 is able to compensate for the ingress of gas or liquid within the flexible, collapsible member 446. The magnitude of the reduced pressure may be designed and controlled by varying the area of the end of the flexible foldable member 446 and the spring force of the constant force coil spring 480.

Although the present invention and its advantages have been disclosed in the context of certain illustrative non-limiting embodiments, it should be understood that various changes, substitutions, permutations and alterations can be made herein without departing from the scope of the invention as defined by the appended claims. It should be appreciated that any feature described in connection with any one embodiment may also be applicable to any other embodiment.

Claims (21)

1. A manually-actuated, reduced-pressure system for treating a wound on a patient, the system comprising:

a manifold member having a first side and a second side facing the patient, the manifold operable to distribute reduced pressure;

a sealing member operable to provide a fluid seal over the manifold member and a portion of a patient;

a reduced-pressure delivery member operable to receive and transmit a reduced pressure, the reduced-pressure delivery member having a first end and a second end;

a reduced-pressure interface fluidly coupled to the second end of the reduced-pressure delivery member and operable to receive reduced pressure from the reduced-pressure delivery member and transmit the reduced pressure to the manifold member; and

a manually-actuated constant reduced pressure source for generating a reduced pressure, the manually-actuated constant reduced pressure source having a reduced pressure port fluidly coupled to the first end of the reduced pressure delivery member, and wherein the manually-actuated constant reduced pressure source comprises a constant force biasing member.

2. The manually-actuated, reduced-pressure system of claim 1, wherein the manually-actuated, constant reduced-pressure source is operable to provide a constant reduced pressure.

3. The manually-actuated, reduced-pressure system of claim 1, wherein the manually-actuated, constant reduced-pressure source is operable to provide a constant reduced pressure, and wherein the manually-actuated, constant reduced-pressure source comprises:

a carrier member;

a slider member slidably coupled to the carrier member;

a flexible, foldable member having a first end and a second end and having an interior space, and the first end being associated with the carrier member and the second end being associated with the slider member;

wherein the carrier member, the constant force biasing member, the slider member, and the flexible and foldable member are sized and configured to allow movement between a compressed position and an expanded position;

a vent operable to allow air or other gas to exit the interior space of the flexibly foldable member; and is

Wherein the constant force biasing member comprises a constant force coil spring operable to drive the carrier member and the slider member away from each other between the compressed position and the extended position.

4. The manually-actuated reduced-pressure system of claim 3, wherein the carrier member is formed with an indicator window therein for viewing a portion of the slider member.

5. The manually-actuated reduced-pressure system of claim 1, wherein the manually-actuated constant reduced-pressure source comprises:

a carrier member having a first socket member formed with a first socket opening, a second socket member formed with a second socket opening, and a carrier cross member coupled to the first socket member and the second socket member;

a slider member having a first arm sized and configured to mate with the first socket opening of the first socket member, a second arm sized and configured to mate with the second socket opening of the second socket member, and a transverse slider member coupled to the first arm and the second arm;

wherein the carrier member and the slider member are operable to slidably engage one another and are operable to move between a compressed position and an expanded position;

a first constant force coil spring coupled to the first socket member proximate the first socket opening, the first constant force coil spring operable to provide a constant force against the first arm to drive the carrier member and the slider member from the compressed position to the extended position;

a second constant force coil spring coupled to the second socket member proximate the second socket opening, the second constant force coil spring operable to provide a constant force against the second arm to drive it from the compressed position to the extended position; and

a flexible and foldable member having a first end and a second end, the first end coupled to the carrier member and the second end coupled to the slider member and operable to move between the compressed position and the extended position.

6. The manually-actuated reduced-pressure system of claim 1, wherein the manually-actuated constant reduced-pressure source comprises:

a flexible and foldable member having a first end, a second end, and an interior space and operable to move between a compressed position and an extended position;

a vent coupled to the flexible and foldable member;

a pressure relief port coupled to the flexible and foldable member;

a carrier member coupled to the first end of the flexibly foldable member;

a slider member coupled to the second end of the flexibly foldable member and operable to slidably engage the carrier member; and is

Wherein the constant force biasing member is associated with the carrier member and the slider member and is operable to drive the slider member and the carrier member away from each other.

7. A manually-actuated reduced-pressure apparatus for use on a reduced-pressure system for treating tissue at a tissue site, the apparatus comprising:

a flexible and foldable member having a first end, a second end, and an interior space and operable to move between a compressed position and an extended position;

a vent coupled to the flexible and foldable member;

a pressure relief port coupled to the flexible and foldable member;

a carrier member coupled to the first end of the flexibly foldable member;

a slider member coupled to the second end of the flexibly foldable member and operable to slidably engage the carrier member and move between the compressed position and the extended position; and

a constant force biasing member associated with a carrier member and a slider member and operable to drive the slider member and the carrier member away from each other between the compressed position and the extended position.

8. The manually-actuated pressure relief device of claim 7, wherein said constant force biasing member comprises a constant force coil spring.

9. The manually-actuated pressure relief device of claim 7, wherein the constant force biasing member comprises a constant force coil spring coupled to the carrier member and operable to provide a constant force that drives the slider member from the compressed position to the extended position.

10. The manually-actuated pressure relief device of claim 7, wherein the constant force bias member comprises first and second constant force coil springs coupled to the carrier member and operable to provide a constant force that drives the slider member from the compressed position to the extended position.

11. The manually-actuated pressure relief device of claim 7, further comprising: an indicator coupled to the carrier member for indicating movement of the device between the compressed position and the extended position.

12. The manually-actuated pressure relief device of claim 7, wherein said carrier member is formed with an indicator window, and further comprising: a visible marking secured to the slider member, and wherein a portion of the visible marking is visible through the indicator window.

13. The manually-actuated pressure relief device of claim 7, wherein said flexible, collapsible member comprises a bellows member.

14. A method of manufacturing a manually actuated pressure relief device, the method comprising the steps of:

forming a carrier member;

forming a slider member, the slider member and the carrier member being formed to slidably engage with each other;

providing a flexible and foldable member having a first end, a second end, and an interior space and movable between a compressed position and an extended position;

coupling the first end of the flexible and foldable member to the carrier member;

coupling the second end of the flexible and foldable member to the slider member;

associating a constant force biasing member with the carrier member and the slider member, the constant force biasing member operable to drive the carrier member and the slider member away from each other between the compressed position and the extended position;

forming a drain on the flexible, foldable member to allow fluid to exit the interior space of the flexible, foldable member when placed in the compressed position; and

a reduced-pressure port is formed in the flexible and foldable member to deliver reduced pressure from the flexible and foldable member.

15. The method of manufacturing a manually actuated pressure relief device according to claim 14, wherein the step of associating a constant force biasing member with the carrier member and the slider member comprises: a constant force coil spring is associated with the carrier member and the slider member.

16. The method of manufacturing a manually actuated pressure relief device according to claim 14, wherein the step of associating a constant force biasing member with the carrier member and the slider member comprises the steps of: coupling a fixed portion of a constant force spring to the carrier member and configuring the slider portion to press against a coil portion of the constant force spring.

17. The method of manufacturing a manually-actuated pressure relief device according to claim 14, wherein the second end of the flexible, foldable member has an area (a), and wherein the area (a) and the force (F) provided by the constant force biasing member are selected to produce a desired Reduced Pressure (RP) at the reduced pressure port, and wherein RP ≈ F/a.

18. The method of manufacturing a manually actuated pressure relief device according to claim 14, further comprising the step of: an indicator is coupled to the carrier member.

19. The method of manufacturing a manually actuated pressure relief device according to claim 14, further comprising the steps of:

attaching a visible marking to a portion of the slider member; and

an indicator window is formed on the carrier member that allows a person to view a portion of the visible indicia.

20. A method of treating a tissue site on a patient with reduced pressure, the method comprising the steps of:

disposing a manifold member proximate to the tissue site;

disposing a sealing member over the manifold member and a portion of the patient's epidermis to form a fluid seal;

coupling a reduced-pressure interface over the sealing member to provide reduced pressure to the manifold member;

providing a reduced-pressure source, wherein the reduced-pressure source comprises a manually-actuated constant reduced-pressure source for generating a reduced pressure, the manually-actuated constant reduced-pressure source having a reduced-pressure port fluidly coupled to a first end of a reduced-pressure delivery member and operable to generate a substantially constant reduced pressure, and wherein the manually-actuated constant reduced-pressure source comprises a constant-force biasing member;

fluidly coupling the reduced-pressure source to the reduced-pressure interface; and

moving the reduced-pressure source to a compressed position.

21. The method of claim 20, wherein the manually-actuated constant reduced pressure source comprises:

a flexible and foldable member having a first end, a second end, and an interior space and operable to move between a compressed position and an extended position;

a vent coupled to the flexible and foldable member;

a pressure relief port coupled to the flexible and foldable member;

a carrier member coupled to the first end of the flexibly foldable member;

a slider member coupled to the second end of the flexibly foldable member and operable to slidably engage the carrier member; and is

Wherein the constant force biasing member is associated with the carrier member and the slider member and is operable to drive the slider member and the carrier member away from each other.