Medical devices with negative pressure sources and related systems and methods of use

Abstract

According to one aspect, a medical device system can include a pouch including a first opening; a gasket coupled to the pouch proximate the first opening; and a tube including a distal portion. The distal portion can be coupled to the gasket and include at least one opening; and the tube can be configured to provide negative pressure therapy to a wound site.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 599,056, filed November 15, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of the present invention generally relate to systems for attaching medical devices to the body, systems for providing negative pressure therapy, and related devices and methods. In particular, various aspects of the present invention relate to devices, systems, and methods for attaching ostomy bags to the body. Background Technology

[0003] In many cases, a consequence of surgery for various gastrointestinal diseases is the creation of an abdominal stoma, such as a colostomy or ileostomy, in the abdominal wall to drain visceral contents. The drainage of visceral contents, including intestinal gas, cannot be regulated at will. Therefore, the patient will need to rely on a device to collect material from such an opening in a bag, such as an ostomy bag, which will then be emptied and / or discarded at an appropriate time. An ostomy involves the removal, bypassing, resection, and / or connection of the colon, ileum, or large intestine to the outside of the body. Stoma sites are often prone to infection or other complications, such as suture dehiscence, stoma site infection, parastomal fistula, skin irritation, pressure ulcers, mucosal separation, and / or skin breakdown.

[0004] This invention can solve one or more of these problems or other problems in the art. Summary of the Invention

[0005] Embodiments of the present invention relate to medical devices and systems for treating patients and / or connecting medical devices to patients, as well as related methods of use. Embodiments of the present invention may promote wound healing, enhance the connection between the medical device and the patient, and / or may help reduce infection at the wound site. Each of the embodiments disclosed herein may include one or more features described in conjunction with any of the other disclosed embodiments.

[0006] According to one aspect, a medical device system may include a bag having a first opening; a liner attached to the bag adjacent to the first opening; and a tube having a distal portion. The distal portion may be attached to the liner and includes at least one opening; and the tube may be configured to provide negative pressure therapy to a wound site.

[0007] In other aspects, the medical device system may include one or more of the following features: A pump assembly may be fluidly coupled to the tubing and may apply negative pressure to the tubing. A liner may be circular and include a central lumen that may be aligned with a first opening. A distal portion of the tubing may extend circumferentially around the central lumen. At least one opening of the tubing may include a plurality of openings that may face toward the liner. A filter assembly may be coupled to the tubing and configured to filter material received from a wound site. The pump assembly may include a pump and a reservoir configured to receive material from the wound site. The liner may include a channel configured to receive the tubing that may extend circumferentially around the central lumen of the liner. The liner may include a perforated portion configured to be removable from the liner. The liner may include a first layer of porous material and a second layer of porous material, and a portion of the tubing may be positioned between the first and second layers of porous material. The liner may include an adhesive on a first side of the liner, and the adhesive may extend across a first portion of the first side of the liner but not across a second portion of the first side of the liner. The medical device system may also include a sheet, with a first side of the sheet configured to attach a bag to the sheet and a second side of the sheet configured to attach a liner to the sheet. The sheet may include a protrusion extending circumferentially around a central cavity of the sheet, and a tube may be located radially outward of the protrusion relative to the central longitudinal axis of the central cavity. The bag may include a pouch, and a pump assembly may be positioned within the pouch. The liner may be C-shaped.

[0008] In other aspects, the medical device system may include a liner configured to be coupled to tissue, wherein the liner includes a central lumen; a first tube having a first distal portion coupled to the liner, extending circumferentially around the central lumen and including at least one opening; and a second tube having a second distal portion coupled to the liner, extending circumferentially around the central lumen and including at least one opening. The first tube is configured to provide negative pressure therapy to a wound site; and the second tube is configured to facilitate coupling of the liner to tissue.

[0009] In other aspects, the medical device system may include one or more of the following features: a first distal portion may include a plurality of openings facing the central lumen, and a second distal portion may include a plurality of openings facing away from the central lumen. A first tube may be configured to apply a first negative pressure, a second tube may be configured to apply a second negative pressure, and the first negative pressure may be different from the second negative pressure. The medical device system may also include an ostomy bag, wherein a liner is attached to the ostomy bag.

[0010] In other aspects, the medical device system may include a liner configured to be coupled to tissue, wherein the liner is a porous material; a tube including a distal portion, wherein the distal portion is coupled to the liner and includes a plurality of openings facing the liner; and a pump assembly coupled to a proximal portion of the tube. The pump assembly may be configured to provide negative pressure to the tube, the medical device system may be configured to provide negative pressure therapy to a wound site, and the tube may be positioned within a channel extending circumferentially around a central lumen of the liner.

[0011] It is understood that the foregoing general description and the following detailed description are exemplary and explanatory only, and are not intended to limit the invention as claimed. As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “conventional.” The term “distal” refers to the portion furthest from the user when the device is introduced into the patient’s body. Conversely, the term “proximal” refers to the portion closest to the user when the device is placed in the patient’s body. Although ostomy bags are mentioned herein, reference to ostomy bags should not be construed as limiting the possible applications of the disclosed aspects. For example, the disclosed aspects may be used with wound dressings, such as adhesive bandages, diagnostic or therapeutic tools or devices, or other types of medical devices. Furthermore, relative terms such as, for example, “about,” “substantially,” “approximately,” etc., are used to indicate possible variations of ±10% in a specified value or range. Attached Figure Description

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0013] Figure 1 This is a perspective view of a medical device system connected to a patient according to various aspects of the present invention.

[0014] Figure 2 This is a perspective view of a part of a medical device according to various aspects of the present invention.

[0015] Figure 3 This is a perspective view of a medical device disassembled according to various aspects of the present invention.

[0016] Figure 4 This is a perspective view of a portion of a medical device system according to various aspects of the present invention.

[0017] Figures 5A to 5D This is a perspective view of parts of a medical device system assembled according to various aspects of the present invention.

[0018] Figure 6A perspective and side cross-sectional view of a portion of a medical device system according to various aspects of the present invention are shown.

[0019] Figure 7 A top view of the distal tip section of a medical device according to various aspects of the present invention is shown.

[0020] Figure 8 A side view of a portion of a medical device according to various aspects of the present invention is shown.

[0021] Figure 9 This is a side view of a medical device according to various aspects of the present invention. Detailed Implementation

[0022] Reference will now be made in detail to various aspects of the invention, examples of which are shown in the accompanying drawings. Where possible, the same or similar reference numerals will be used in all the drawings to refer to the same or similar parts.

[0023] Embodiments of the present invention aim to improve the connection between medical devices and patients, reduce infection at the wound site, alleviate pain and complications at the wound site, promote wound healing, and / or facilitate the drainage of fluid from the patient. Embodiments of the present invention also aim to improve ostomy bags and related devices, and to improve treatment methods using negative fluid pressure.

[0024] Figure 1 An exemplary medical device system 100 is illustrated. The medical device system 100 may include a bag 115, a sheet 110, a liner 112, one or more tubes 127, 128, and a pump assembly 135. The bag 115 may be an ostomy bag and may include a distal opening 117 and a proximal opening 114 covered by a proximal cap 116. The bag 115 may be attached to a patient 101 via the sheet 110 and the liner 112. For example, the bag 115 may be attached to the patient's abdomen and may be configured to receive substances and / or fluids from the patient 101's digestive system, such as when the small or large intestine has been removed. The proximal cap 116 may provide the patient with a means of emptying the bag 115, which is done by removing the proximal cap 116 and disposing of the substances collected in the bag 115. The bag 115 may be plastic or any other suitable material.

[0025] Bag 115 may be directly attached to sheet 110, pad 112, or both sheet 110 and pad 112. Sheet 110 and / or pad 112 may include one or more adhesives configured to attach to the skin of patient 101, such as the skin surrounding the wound site of patient 101. Each of sheet 110 and pad 112 may include a central cavity, such as a central cavity 217 configured to align with the wound / resection site of patient 101. Figure 2(As shown in the diagram). Tube 127 may be coupled to liner 112 and / or sheet 110, and tube 127 may be configured to provide negative pressure therapy to patient 101 in close proximity to the wound / resection site. One or more tubes 127, 128 are operatively coupled to pump assembly 135, and pump assembly 135 may apply negative fluid pressure to one or more tubes 127, 128. In some examples, filter assembly 129 may be coupled between pump assembly 135 and sheet 110 and / or liner 112 to one or more tubes 127, 128.

[0026] Pump assembly 135 may include a pump, a reservoir for receiving material from one or more tubes 127, 128, and one or more actuators 130-133. Pump assembly 135 may also include any suitable connectors (e.g., piping for fluidly connecting components of the pump assembly). Pump assembly 135 may be configured to supply negative pressure to one or more tubes 127, 128. Tubes 127, 128 may be releasably coupled to pump assembly 135, allowing a user to connect and disconnect one or more tubes 127, 128 from pump assembly 135. Pump assembly 135 may receive material collected from patient 101 by negative pressure applied to one or more tubes 127, 128, for example, to promote wound healing and assist in attaching bag 115 to patient 101. In some examples, pump assembly 135 may generate a pressure of about 60 mmHg to about 130 mmHg (inclusive), and a user may select any pressure within this range to apply to one or more tubes 127, 128. For example, pump assembly 135 can apply a negative pressure of 125 mmHg to one or more pipes 127, 128. In some examples, pump assembly 135 may be preset to start at a given desired pressure, such as 125 mmHg. The reservoir of pump assembly 135 may be a tank or any other suitable container for collecting substances. Filter assembly 129 may be configured to capture and / or filter solid and / or semi-solid substances and prevent such substances from entering pump assembly 135.

[0027] In some examples, pump assembly 135 may be configured to be portable (e.g., lightweight and sized to fit and be carried by patient 101). For example, bag 115 may include pump assembly 135 delivery devices such as pouches, belts, clips, hooks, and / or loops to maintain access to bag 115 and provide mobility to the patient undergoing negative pressure (i.e., vacuum) therapy. As discussed in further detail below, negative pressure supplied from pump assembly 135 to one or more tubes 127, 128 may provide suction to pad 112 and / or sheet 110 to treat patient 101 and / or facilitate attachment of bag 115 to patient 101.

[0028] Figure 2 An exemplary portion 200 of a medical device system 100 is shown, including a pad 206 and a tube 227. (See diagram below.) Figure 2 As shown, the gasket 206 may include a central cavity 217, and a central axis 240 may extend through the central cavity 217. Figure 2 (Seen as extending through the page). Pad 206 may be made of open-cell foam and / or any porous material configured to allow fluid flow through the material. In some examples, pad 206 may be a layered dressing with channels to provide a fluid pathway to patient tissue. Pad 206 may include a layered dressing with different layers to provide fluid flow, absorbent material, storage of removed fluid and waste, a drying layer, and / or a layer or coating, such as silver, for providing an antimicrobial treatment. Tube 227 may be coupled to a first side 241 of pad 206 (shown facing outwards away from the page), and an adhesive layer may be located on a portion (or all) of a second side 242 (shown facing inwards towards the page), the second side 242 facing in the opposite direction to the first side 241.

[0029] The tube 227 may be attached to the gasket 206, for example, by adhesive or any other connection method known in the art. The distal portion of the tube 227 may be coiled or wound around the central axis 240 and may be attached only to the first side 241 of the gasket 206. The proximal portion (not shown) of the tube 227 may be attached to the pump assembly 135. The tube 227 may include one or more openings 231-233 on a surface of the tube 227 that are radially outward relative to the longitudinal axis of the tube 227, and may also include a distal opening 236. In some examples, the tube 227 may not include the distal opening 236 and may include a closed distal end. In some examples, each of the openings 231-233 may face the first side 241 of the gasket 206. In some examples (not shown), the tube 227 may be arranged on the first side 241 of the gasket 206 in a single-loop pattern, a wavy pattern, a series of connected annular loops, a C-shape, or any other suitable configuration. The liner 206 may be configured to attach to the tissue of the patient 101, and the tube 227 may be configured to apply negative pressure to the liner 206. Thus, the tube 227 may provide suction on the patient tissue via negative pressure applied to one or more openings 231-233, 236 to draw material through the liner 206 to the tube 227.

[0030] During use, portion 200 may be attached to sheet 110, and then pad 206 may be attached to patient 101 at the wound / resection site. In other examples, medical device system 100 may not include sheet 110, and pad 206 may be directly attached to bag 115. Bag 115 may be attached to sheet 110 and / or pad 206 before or after portion 200 is attached to patient 101. Once attached to patient 101, negative pressure may be applied to one or more tubes 127, 128, 227 to supply negative pressure to openings 231, 232, 233 of tube 227. The supplied negative pressure may apply suction to the tissue of patient 101 at and / or immediately adjacent to the wound site. Substances or fluids from the tissue of patient 101 may be drawn through pad 206 into tube 227 and collected by pump assembly 135. The negative pressure supplied to tube 207 at the wound site promotes tissue healing, helps reduce the risk of wound site contamination, helps prevent infection, facilitates connection of bag 115 to patient 101, and / or allows collection of waste and / or other substances from the patient's digestive tract. Patient 101 or other users can adjust the negative pressure applied to tube 207 by actuating pump assembly 135, for example, to increase or decrease the fluid negative pressure applied to the wound site.

[0031] Figure 3 Another exemplary detachable portion 300 of a medical device system (e.g., medical device system 100) is shown, including pads 306, 307, and tube 327. The first pad 306 may be an absorbent material and may include a central cavity 317 and a channel 350 extending through a first side 341 of the first pad 306. The channel 350 may be configured to receive the tube 327 and may extend around the central cavity 317. The depth of the channel 350 (into the first pad 306) may be equal to or greater than the diameter of the tube 327. In some examples, the channel 350 may be cut into or otherwise formed in the first pad 306 to retain an opening in the first pad 306. For example, the first pad 306 may be cut mechanically or by high heat to vaporize / pyrolyze portions of the first pad 306 so as not to close the opening in the first pad 306. A second side 343 of the first pad 306 may include an adhesive and may be configured to attach to a sheet 110 and / or a bag 115. In some examples, the distal portion 361 of tube 327 may be fixedly connected within channel 350, and one or more openings 331-333 of tube 327 may face opening 363 of channel 350. Although channel 350 is shown as a spiral, channel 350 may have any suitable shape, such as a wavy pattern, connected concentric rings, or any other shape.

[0032] The second liner 307 may be configured to attach to and at least partially align with the first liner 306. The second liner 307 may include a first side 342, a second side 344, and a central lumen 366. The first side 342 of the second liner 307 may include tissue configured to attach to the patient 101. Figure 1 The second side 344 may include an adhesive configured to attach to the first liner 306. In an assembled configuration, the second liner 307 may be positioned on the first liner 306 such that the tube 327 is positioned within the channel 350 and between the first liner 306 and the second liner 307. The second liner 307 may be porous and configured to allow fluid flow through the second liner 307 to the tube 327. In some examples, the first liner 306 and / or the second liner 307 may include one or more perforated portions 355, and the perforated portions 355 may be configured to allow a user to remove a portion of the first liner 306 and / or the second liner 307, for example, to resize the central cavities 317, 366. The perforated portions 355 may allow a user to adjust the size of the liners 306, 307 to accommodate different sized wounds / resections.

[0033] Figure 4 An exemplary portion 400 of a medical device system (e.g., medical device system 100) is shown, comprising a bag 415, a sheet 410, and a pad 406. The bag 415 is shown as having a coupling frame 418 having a first opening 417 surrounding the bag 415. The bag 415 is also shown as having a cap 431 on a second opening of the bag 415. Ridges 412 of the sheet 410 may be received by the coupling frame 418 of the bag to attach the bag 415 to the sheet 410. In some examples, the sheet 410 may be screwed into the coupling frame 418 via one or more threads of the sheet 410 and / or the coupling frame 418. The central cavity 426 of the pad 406 and the sheet 410 may be configured to be at least partially aligned with a wound site of the patient 101. Figure 1 The liner 406 is configured to receive waste and / or other substances or fluids from patient 101. In some examples, the liner 406 may include a removable protective cap 471 on one side of the liner 406 configured to attach to tissue of patient 101. The cap 471 may include lugs extending radially outward from / outside the liner 406. A user may remove the protective cap 471 to expose the adhesive on the liner 406 and allow the user to push the adhesive of the liner 406 onto the tissue of patient 101 to attach the liner 406 to patient 101.

[0034] Figures 5A to 5D A method for attaching a disc-shaped vacuum treatment liner 506 to a sheet 510 of an ostomy bag is shown. Figure 5A and Figure 5B The user is shown peeling off the protective cover 571 to expose the adhesive present on the first side 511 of the sheet 510. Figure 5C This illustrates a user pushing or otherwise forcing the liner 506 onto the adhesive exposed on the sheet 510, wherein the tube 527 extends from the liner 506. Figure 5D The user is shown pushing or otherwise forcing the pad 506 onto the first side 511 of the sheet 510 to securely attach the pad 506 to the sheet 510. Once the pad 506 is attached to the sheet 510, the user can attach an ostomy bag (not shown) to the sheet 510 and continue attaching the pad 506 to the patient 101. As mentioned above, the pad 506 can absorb material and / or fluid from the wound site of the patient 101 and can apply negative pressure via the tube 571.

[0035] Figure 6 Various embodiments of a sheet 610 including protruding portions configured to isolate negative pressure treatment applied by a pad 606 from waste contents transferred from patient 101 to bag 115 are shown. A central axis 640 of the cavity 617 of the sheet 610 and pad 606 is shown extending through each example sheet 621-624. Each example sheet 621-624 is shown in a side cross-sectional view to show protruding portions 661-665 of each example sheet 621-624, and each protruding portion 661-665 extends circumferentially completely around the central axis 640. Each example sheet 621-624 includes a wound / resection site configured to attach to patient 101. Figure 1 The adhesive portion 611 of the sheet 621. A first example sheet 621 includes an outwardly curved protrusion 661, configured to contact a portion of the patient 101 when the sheet 621 and the pad 606 are attached to the patient 101. A second example sheet 622 includes a hook-shaped protrusion 662, which is curved toward a central axis 640. A third example sheet 623 includes a hook-shaped protrusion 663, which is curved away from the central axis 640. A fourth example sheet 624 includes protrusions 664 and 665. Protrusion 664 extends outward (towards the patient's tissue). Protrusion 665 extends inward (i.e., toward the central axis 640) and is configured to be flush with the tissue of the patient 101 when the sheet 624 and the pad 606 are attached to the patient 101. Each of sheets 621-624 is configured to isolate the negative pressure treatment applied by pad 606 to a portion located outside the wound / resection opening of patient 101. Each of sheets 621-624 is configured to prevent aspirated waste and / or other substances from being transferred from the patient's digestive tract into bag 115. Figure 1 In some examples, any of the sheets 621-624 may not include the adhesive portion 611.

[0036] Figure 7An exemplary medical device system 700 is shown, which includes a bag 715, a sheet 710, a pad 706, a tube 727, and a pump assembly 725. The medical device system 700 may have any of the features described herein with respect to medical device system 100. Figure 7 As shown, bag 715 may include a pouch portion 755 configured to hold pump assembly 725. Pouch portion 755 may include an opening 776 configured to receive tube 727. In some examples, pouch portion 755 may be positioned on the side of bag 715 opposite to the distal opening 717 of bag 715. A coupling frame 718 of bag 715 may be coupled to sheet 710, for example, by engaging the ridge portion 723 of sheet 710.

[0037] The sheet 710 may include a protrusion 711, and the protrusion may be associated with other protrusions, such as Figure 6 Any of the protrusions shown are interchangeable. A liner 706 may be coupled to a sheet 710, and a tube 727 may extend to the liner 706 to supply negative pressure to the liner 706. In some examples, the bag 715 may be transparent or at least partially transparent to allow a user to see the contents within the bag 715. The medical device system 700 may be portable and may allow the patient 101 to move while the medical device system 700 is coupled to the patient 101.

[0038] Figure 8 An exemplary liner 806 is shown, which may be incorporated into any of the medical device systems 100, 700 described herein, and may have any of the features of the liners 112, 206, 306, 406, 506, 606, 706 described herein. The liner 806 may be C-shaped or have a shape with an incomplete disc to allow for replacement of the liner 806 without disassembling the entire medical device system 100, 700 (e.g., without removing the pouch 115, etc.). A tube 827 may extend circumferentially around a central lumen 817, and openings 831-833 may face away from the liner 806 to treat the anastomosing tissue with negative pressure. In other examples, openings 831-833 may face the liner 806 and may be configured to treat the anastomosing tissue with negative pressure through the liner 806 (e.g., by extending through the openings / fluid chambers of the liner 806). The gap 826 extends from the central cavity 817 to the outermost radial portion of the liner 806 relative to the central axis 840. To replace the liner 806, the vacuum source (e.g., pump assembly 135, 725) can be shut off, and the liner 806 can be removed. The liner 806 can then be replaced with a new C-shaped liner. By providing the C-shaped liner 806, the user can adjust the size of the central cavity 817 by overlapping a portion of the C-shaped liner (e.g., pulling some portions of the liner 806 together to eliminate the gap 826) to reduce the diameter of the central cavity 817, or by pulling apart the ends of the C-shaped liner 806 to allow for a larger central cavity 817.

[0039] The liner 806 facilitates attachment of the bag 115 to the patient 101, for example, to the stoma site. Alternatively or additionally, the liner 806 may help enhance adhesion of the bag 115 to the patient 101 and / or allow for the use of less adhesive to attach the bag 115 to the patient 101. By reducing the amount of adhesive required to attach the bag 115 to the patient 101, irritation and infection at the stoma site (e.g., wound / resection site) can be reduced.

[0040] Figure 9 An exemplary liner 906 is shown, which may be incorporated into any of the medical device systems 100, 700 described herein, and may have any of the features of liners 112, 206, 306, 406, 506, 606, 706, 806 described herein. The liner 906 may be C-shaped or have a partially disc-like shape to allow for replacement of the liner 906 without disassembling the entire medical device system 100, 700 (e.g., without removing the pouch 115, etc.). A first tube 927 and a second tube 928 may be coupled to a first side 941 of the liner 906. Each of the first tube 927 and the second tube 928 may extend circumferentially about a central cavity (and central axis 940). The first tube 927 may include openings 931-933 opposite to the first side 941, and the second tube 928 may include openings 934-936 opposite to the first side 941. Connector 961 may receive first tube 927 and second tube 928, and connector 961 may be spaced apart from the radially outermost portion of pad 906 relative to central axis 940. Separation portion 955 may extend circumferentially about central axis 940 and may separate distal portion 956 of first tube 927 from distal portion 957 of second tube 928.

[0041] The separating portion 955 may be a protruding portion of the liner 906, a partition wall made of plastic or another impermeable material, an adhesive portion, or any other structure configured to fluidly isolate the distal portion 956 from the distal portion 957. By fluidly isolating the distal portion 956 from the distal portion 957 when the liner 906 is attached to the patient, the first tube 927 may be configured to assist in attaching the liner 906 to the patient 101, and the second tube 928 may be configured to treat the wound site with negative pressure therapy. For example, a higher level of negative pressure may be applied to the first tube 927 to facilitate attachment of the liner 906 to tissue, and a lower level of negative pressure may be applied to the second tube 928 to treat the tissue surrounding the wound site.

[0042] In some examples, openings 931-933 may be angled away from the wound site to help prevent aspiration of material from the wound site, and openings 934-936 may be angled toward the central axis 940 (i.e., toward the wound site) to facilitate collection of material or fluid from the wound site. In some examples, an adhesive patch 951 may be used with the liner 906 to facilitate attachment of the liner 906 to the tissue of the patient 101. In other examples, the adhesive patch 951 may not be used, and the liner 906 may be directly attached to the tissue of the patient 101. In some examples, the first tube 927 may include additional openings 934-936 facing the sheet 110 to facilitate attachment of the liner 906 to the sheet 110. By providing tubes 927, 928 on the liner 906, two distinct treatment areas can be achieved on the liner 906 and separated by a separation portion 955. In some examples, the padding material of the additional layer (e.g., porous material, dressing, etc.) may cover the first tube 927 but not the second tube 928, or vice versa.

[0043] Any of the medical device systems 100 and 700 described herein may incorporate any and / or any other feature of the pads 112, 206, 306, 406, 506, 606, 706, 806, and 906 described herein.

[0044] In any of the above embodiments, the medical device system 100, 700 may include one or more components that are metal, polymer, machined, molded, stamped, insert-molded, or any combination thereof. Any aspect of any of the above embodiments of the medical device system 100, 700, pads 112, 206, 306, 406, 506, 606, 706, 806, 906, or other parts of the medical device system may be incorporated into any of the other medical device systems 100, 700 described herein.

[0045] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will become apparent to those skilled in the art upon consideration of this specification and the features disclosed herein. This specification and embodiments should be considered as exemplary only.

Claims

1. A medical device system, comprising: A bag with a first opening; A liner attached to the bag immediately adjacent to the first opening; as well as A tube having a distal portion, wherein the distal portion is coupled to the gasket and includes at least one opening; The tube is configured to provide negative pressure therapy to the wound site.

2. The medical device system of claim 1, further comprising a pump assembly fluidly connected to the tube, wherein the pump assembly applies negative pressure to the tube.

3. The medical device system according to any one of the preceding claims, wherein the liner is circular and includes a central cavity, and wherein the central cavity is aligned with the first opening.

4. The medical device system according to any one of the preceding claims, wherein the distal portion of the tube extends circumferentially around the central cavity.

5. The medical device system of claim 4, wherein the at least one opening of the tube comprises a plurality of openings, and wherein the plurality of openings face the liner.

6. The medical device system according to any one of the preceding claims further includes a filter assembly coupled to the tube, the filter assembly being configured to filter substances received from the wound site.

7. The medical device system of claim 2, wherein the pump assembly includes a pump and a reservoir configured to receive material from a wound site.

8. The medical device system according to any one of the preceding claims, wherein the liner includes a channel configured to receive the tube, wherein the channel extends circumferentially around a central cavity of the liner.

9. The medical device system according to any one of the preceding claims, wherein the liner includes a perforated portion configured to be removable from the liner.

10. The medical device system according to any one of the preceding claims, wherein the liner comprises a first layer of porous material and a second layer of porous material, and wherein a portion of the tube is positioned between the first layer of porous material and the second layer of porous material.

11. The medical device system according to any one of the preceding claims, wherein the liner includes an adhesive on a first side of the liner, and wherein the adhesive extends across a first portion of the first side of the liner but not across a second portion of the first side of the liner.

12. The medical device system according to any one of the preceding claims further includes a sheet, wherein a first side of the sheet is configured to attach the bag to the sheet, and wherein a second side of the sheet is configured to attach the pad to the sheet.

13. The medical device system of claim 12, wherein the sheet includes a protrusion extending circumferentially around a central cavity of the sheet, and wherein the tube is located radially outside the protrusion relative to the central longitudinal axis of the central cavity.

14. The medical device system of claim 2, wherein the bag comprises a pouch, and the pump assembly is positioned within the pouch.

15. The medical device system according to any one of the preceding claims, wherein the liner is C-shaped.

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