Luminous Endoscopic Treatment Devices

Abstract

A medical device comprising a distal body coupled to the distal end of a vacuum tube. The distal body may communicate with the lumen of the vacuum tube. The distal body may include a core having multiple openings and one or more layers surrounding the core.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to minimally invasive medical devices. In particular, aspects of the present disclosure relate to medical devices for endoscopic medical procedures such as wound closure and treatment of other tissues.

Background Art

[0002] Endoscopic surgeries and open surgeries of the gastrointestinal (GI) tract include, for example, colectomy, obesity surgery, esophagectomy, gastric bypass surgery, sleeve gastrectomy, etc. These surgeries may cause perforation of the GI tract, postoperative leakage, and other wounds. Patients with perforation, postoperative leakage, and / or other wounds in the GI tract have a high mortality rate, and the treatment options are limited. The options include endoscopic placement of clips and stents, endoscopic suturing and sealants, or surgical reoperation. Surgery is relatively invasive and has a high morbidity and mortality rate. Endoscopic stent placement is a less invasive option, but the stent may move from the target position and / or enclose the infection at the treatment site and prevent drainage.

[0003] The medical device of the present disclosure can improve some of the above-mentioned defects or address other aspects of the technology.

Summary of the Invention

[0004] Each aspect disclosed herein can include one or more of the features described in relation to any of the other disclosed aspects. In one aspect, the medical device can include a distal body coupled to the distal end of a vacuum tube. The distal body can communicate with the lumen of the vacuum tube. The distal body can include a core having a plurality of openings and one or more layers surrounding the core.

[0005] Any embodiment disclosed herein may include any one or any combination of the following features: At least one of the one or more layers may define a plurality of openings; the plurality of openings in the one or more layers may have an average size smaller than the average size of the plurality of openings in the core; the one or more layers may completely surround the core; the one or more layers may surround only a portion of the core; the one or more layers may be coated with an antimicrobial material; at least one of the one or more layers may be attached to the distal end of the vacuum tube via a clip, drawstring, or suture; at least one of the one or more layers may include one or more projections extending radially outward from the outer surface of at least one of the one or more layers; the one or more layers may include a first layer surrounding the core and a second layer surrounding the first layer; the absorbency of the second layer may be greater than that of the first layer, and the absorbency of the first layer may be greater than that of the core. The core may contain a hydrophobic material, and the first and second layers may contain a hydrophilic material. The proximal portion of the outer surface of the second layer may contain an adhesive. One or more layers may be coated with a material containing alginate. The core may contain a first channel and a second channel. The first and second channels may extend from the proximal end to the distal end of the core. The distal ends of the first and second channels may terminate proximal to the most distal end of the core. The first and second channels may join at the proximal end of the core to form a third channel.

[0006] In another example, a medical device may include a distal body coupled to the distal end of a vacuum tube. The distal body may communicate with the lumen of the vacuum tube. The distal body may include a core and at least one layer surrounding the core. The core may include a plurality of openings arranged on its outer surface, a first channel, and a second channel. The first channel and the second channel may meet at the proximal end of the core to form a third channel.

[0007] Any embodiment disclosed herein may include any one or any combination of the following features: The distal ends of the first channel and the second channel may be closed; The third channel may be adjacent to the lumen of the vacuum tube.

[0008] In a further embodiment, the medical device may include a distal body coupled to the distal end of a vacuum tube. The distal body may include a core having a plurality of openings communicating with the lumen of the vacuum tube. The distal body may further include a first layer surrounding the core and a second layer surrounding the first layer. Each of the first and second layers may include a plurality of openings. Each of the plurality of openings in the first and second layers may have an average size smaller than the average size of the plurality of openings in the core. The outer surface of the second layer may include a plurality of projections extending radially outward. [Brief explanation of the drawing]

[0009] The accompanying drawings incorporated herein and forming part thereof illustrate various aspects of this disclosure and, together with the specification, help to illustrate the principles of this disclosure. [Figure 1A] Exemplary medical devices according to aspects of this disclosure are shown. [Figure 1B] Exemplary medical devices according to aspects of this disclosure are shown. [Figure 2] Another exemplary medical device according to aspects of this disclosure is shown. [Figure 3] Further exemplary medical devices according to aspects of this disclosure are shown. [Modes for carrying out the invention]

[0010] Detailed explanation Specific aspects of this disclosure are described in more detail below. In the event of any conflict between terms and definitions provided herein and terms and / or definitions incorporated by reference, the terms and definitions provided herein shall prevail.

[0011] In this specification, the terms “proximal” and “distal” are used to refer to the relative locations of components of an exemplary medical device. As used herein, “proximal” refers to a location relatively close to the outside of the body or close to the operator using the medical device. Conversely, “distal” refers to a location relatively far from the operator using the medical device or close to the inside of the body.

[0012] As used herein, the terms “includes,” “contains,” “have,” or other variations thereof are intended to be non-exclusive. That is, a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may also include other elements that are not expressly listed or that are inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” not “ideal.”

[0013] Furthermore, relative terms such as "approximately," "substantially," and "roughly" are used to indicate that the stated numerical value or range may vary by ±10%. Endoluminal vacuum therapy (EVT or EVAC, hereinafter referred to as EVAC) is a procedure to treat wounds in the gastrointestinal tract (GI) such as postoperative leakage or perforation following surgical or endoscopic procedures such as colectomy, bariatric surgery, or esophagectomy. In EVAC, negative pressure is delivered to the wound site in the GI tube, for example, through a nasogastric tube having a sponge / foam (e.g., vacuum-sealed foam) at its distal end. The proximal end of the tube may be connected to a collection container combined with the negative pressure source. The foam is inserted into the perforation, leakage, or other wound by endoscopy. In some cases, EVAC involves endoscopic placement of foam or other similar material into the wound site (e.g., target) such as perforation, leakage, cyst, or anastomosis. Placement of the material may be performed by inserting a catheter, scope (endoscope, bronchoscope, colonoscope, duodenoscope, gastroscopy, etc.), tube, or sheath into the GI tube through a natural opening. The openings mentioned above are, for example, the nose, mouth, or anus, and the material may be placed in any part of the GI tube, including the esophagus, stomach, duodenum, large intestine, or small intestine. The material may also be placed in other organs accessible via the GI tube (e.g., the colon, bile duct, appendix, etc.). Negative pressure is then applied.

[0014] The foam within the wound, combined with negative pressure, can accelerate healing by promoting granulation tissue formation in the local tissue at the wound site. As the wound heals and closes, the foam may be replaced with a smaller size foam. There are limited devices and systems suitable for EVAC. For example, in EVAC, the foam typically needs to be replaced every 3-5 days to reduce the risk of tissue endografting. Furthermore, wound infection can occur, which can prolong wound healing.

[0015] Aspects of this disclosure include devices for reducing the number of foam changes during EVAC. Components of the devices described herein may be packaged as an EVAC kit. For example, the devices disclosed herein may include a distal body coupled to the distal end of a tube. The distal body may include multiple materials. For example, the distal body may include multiple material layers. The distal body may include a central sponge / foam surrounded by one or more other materials covering at least a portion of the sponge. In some embodiments, the distal body may include a textured outer layer (e.g., a drape) that can inhibit tissue infiltration into the distal body. In additional or alternative embodiments, the distal body may include layers having, for example, antimicrobial or antibacterial properties, collagen that promotes tissue growth, enhanced absorbency, properties that provide exudate storage or recovery, properties that assist in the removal of the distal body, properties that prevent migration, and / or hydrophilic or hydrophobic properties. The distal body configuration can provide improved absorption, enhanced fluid flow, promotion of tissue granulation, prevention or inhibition of tissue endoplasmosis, prevention or inhibition of infection, and / or assistance in drying.

[0016] Hereinafter, we refer in detail to the embodiments of this disclosure described above and shown in the attached drawings. Wherever possible, the same or similar parts are referred to using the same reference numeral throughout the drawings. Figures 1A and 1B show the distal end of an exemplary EVAC device 100, which is inserted into a patient for wound treatment or used to aid in tissue healing. Figures 1A and 1B show a cross-sectional view of the EVAC device 100. The EVAC device 100 may include a distal body 102 and a vacuum tube 104 or other type of conduit. The distal body 102 may be fixedly or detachably coupled to the distal end 103 of the vacuum tube 104.

[0017] The distal body 102 may include a core 120 containing a foam, such as a sponge. The core 120 can have any features of any foam known in the art for use in EVAC procedures. For example, the core 120 may contain open-cell foam. The core 120 may include openings 106 on its outer surface and / or interior. The openings 106 can be any holes, pores, or channels. The openings 106 may contain interconnecting channels and / or pores throughout the core 120. For example, the openings 106 may be pores in the foam of the core 120. The openings 106 may have various sizes and shapes. The features of the openings 106 (e.g., size and shape of the pores in the foam of the core 120) may be selected based on the location of treatment in the body, the characteristics of the wound being treated, the stage of treatment, or other factors. The distal body 102 containing the core 120 is shown to have a rectangular parallelepiped shape, but can have any shape, such as spherical, cylindrical, or irregular. In some examples, the size of the opening 106 may be approximately 500 μm to 1.0 mm in diameter. The opening 106 may be uniform or non-uniform in size, and in some examples, it may be larger than 1.0 mm. The distal body 102 may be compressed to a lower profile during insertion into the target site and expanded during deployment at the target site.

[0018] The core 120 may contain any suitable biocompatible material that can absorb liquids and / or allow liquids or other substances to pass through, for example, the negative pressure applied to the distal body 102. The material of the core 120 may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. For example, the material of the core 120 may be open-cell foam. Suitable materials include polyurethanes, esters, ethers, composites, and / or other medical-grade materials.

[0019] The vacuum tube 104 may include an outer wall 108 defining one or more lumens 110. The lumen 110 may open at both the proximal end (not shown) of the vacuum tube 104 and at the distal end 103, which is either in or connected to the distal body 102. In some examples, the outer wall 108 may include a number of holes along the circumference of the distal end 103 of the vacuum tube 104 that communicate with the lumen 110, thereby increasing the flow of fluid or material into the lumen 110. The distal end 103 of the vacuum tube 104 may be attached to the distal body 102 via sutures or other knots, adhesives, shrink wrap materials, elastic bodies, etc. In one example, a recess (not shown) may be provided in a core 120 (e.g., the proximal end of the core 120) and / or another part of the distal body 102 to receive the distal end 103 of the vacuum tube 104. The proximal end of the vacuum tube 104 may be connected to a vacuum source (not shown) capable of supplying negative pressure to the distal body 102. For example, a negative pressure of about 125 mmHg, or about 17.2 kPa (about 2.5 pounds per square inch (PSI)), may be supplied to the distal body 102, including the core 120. Other appropriate amounts of negative pressure may also be used. The negative pressure may promote healing at the target site by drawing fluid, material, and / or other debris into the lumen 110 of the vacuum tube 104 through the opening 106 of the core 120.

[0020] The distal body 102 may further include a cover 112 that surrounds or covers all or part of the core 120 and optionally part of the distal end 103 of the vacuum tube 104. The cover 112 may include perforations 118, such as microperforations. The perforations 118 may extend throughout the entire thickness of the cover 112 (or may communicate with each other to provide a path through the wall of the cover 112). The perforations 118 of the cover 112 may be sized to be large enough to allow fluid flow through the perforations 118, but small enough to prevent or inhibit tissue infiltration into the cover 112. Similar to the opening 106, the size of the perforations 118 may range from about 500 μm to about 1.0 mm in diameter. In some examples, the size of the opening 106 may be larger than the size of the perforations 118. The cover 112 may have properties that maintain the absorption properties of the core 120, and the cover 112 may form a protective layer around the core 120. Examples of materials for the cover 112 include polyurethane ether, polyurethane ester, polyvinyl alcohol, stretched polytetrafluoroethylene (PTFE), perforated PTFE, polyethylene, ChronoFlex C®, and / or polyvinylidene fluoride (PVDF).

[0021] The proximal end of the cover 112 may include an opening 116, and the distal end of the core 120 can be inserted into the opening 116 of the cover 112. Next, the cover 112 can be pulled proximally over the distal body 102 (or the distal body 102 can be moved distally within the cover 112) so as to cover the core 120 (e.g., so as to completely or partially cover the core 120) and optionally also cover a portion of the distal end 103 of the vacuum tube 104. The cover 112 can then be fixed to the distal end 103 of the vacuum tube 104 or the core 120 by means such as a clip, drawstring, elastomer, suture, heat-shrinkable capture material, etc. In some examples, the cover 112 can be provided as part of an EVAC kit packaged with the core 120 and the vacuum tube 104. The user can attach the cover 112 as described above. In other examples, the EVAC device 100 may come with the cover 112 already attached in a predetermined position. In some examples, the cover 112 can be fixedly coupled to the core 120. In other examples, the cover 112 can be removably coupled to the core 120.

[0022] In some examples, the cover 112 may optionally include a protrusion 114 that extends radially outward from the outer surface of the distal body 102 (or from the outer surface of the cover 112). The protrusion 114 can help promote wound healing by contacting and / or rubbing against the tissue wall of the target site to induce tissue inflammation and tissue granulation. The protrusion 114 can be made of the same material as the rest of the cover 112. Alternatively, the protrusion 114 may be made of a different material. The protrusion 114 can have any suitable shape and size. Although the protrusion 114 is not shown in FIG. 1B, it will be understood that the protrusion 114 may be disposed on the cover 112 of FIG. 1B. Alternatively, the protrusion 114 may be omitted.

[0023] FIG. 1B shows the distal body 102 (including the core 120 and the cover 112) disposed at the target site 170. When negative pressure is supplied to the vacuum tube 104, the negative pressure can draw fluid or substances into the lumen 110 through the opening / perforation 118 of the cover 112 and the opening 106 of the core 120. The arrows shown in FIG. 1B indicate the flow of fluid or substances through the opening / perforation 118 and the opening 106. The cover 112 can provide a protective layer around the core 120, for example, by preventing tissue growth into the distal body 102 without inhibiting the flow of fluid from the target site 170 to the distal body 102. As shown in FIG. 1B, it is possible for tissue not to grow in either the cover 112 or the core 120.

[0024] FIG. 2 shows the distal end of another exemplary EVAC device 200. The EVAC device 200 can have characteristics similar to those of the EVAC device 100 unless otherwise described herein. Where possible, 100 is added to the reference numbers related to the EVAC device 100 that are similar to the aspects of the EVAC device 200. The EVAC device 200 can include a multi-layer distal body 202 (e.g., a multi-layer porous distal body 202) and a vacuum tube 204. Similar to the vacuum tube 104, the vacuum tube 204 can include an outer wall 208 and a lumen 210, and the proximal end of the vacuum tube 204 can be connected to a vacuum source (not shown). The outer wall 208 can include a plurality of holes communicating with the lumen 210 along the circumference of the distal end of the vacuum tube 204, thereby increasing the flow of fluid or substances from one or more layers of the distal body 202 to the lumen 210. The distal end 203 of the vacuum tube 204 can be attached to the distal body 202 via a suture, an adhesive, etc. (including the examples described above with respect to the EVAC device 100). In one example, a recess (not shown) for receiving the distal end 203 of the vacuum tube 204 can be provided in the distal body 202.

[0025] In some examples, the distal body 202 may include an inner core 220 covered with or layered with one or more intermediate layers 222 and / or outer layers 224 (e.g., mesh outer layers). In Figure 2, the intermediate layers 222 and / or outer layers 224 are shown partially excised to illustrate the features of the core 220 and / or intermediate layers 222. The core 220 may be referred to herein as one of the layers of the distal body 202. By interposing the intermediate layers 222 and / or outer layers 224, the core 220 can be prevented from contacting the tissue of the target site, while the outer layers 224 can be configured to contact the tissue wall of the target site. The core 220 may include an open-cell foam structure with openings 226 having any of the characteristics of the openings 106 described above. The opening 226 may be any hole, pore, or channel that accesses the interconnecting channels and / or pores of the core 220, allowing fluid and / or material to flow into the lumen 210 of the vacuum tube 204. The size of the opening 226 may be similar to that of the opening 106. For example, the size of the opening 226 may be approximately 500 μm to 1.0 mm in diameter. In some examples, the opening 226 may be of a uniform size. Alternatively, the size of the opening 226 may vary.

[0026] The layers of the distal body 202 may have various features to support the EVAC procedure. The features disclosed below are illustrative and may be used in any combination. In some examples, a single layer 224, 222, 220 may include material having several of the features described below. Features described for use in any of layers 224, 222, 220 may also be used additionally or alternatively in other layers.

[0027] In some examples, the absorbency of the distal body 202 may increase from the outer layer 224 toward the core 220. For example, the core 220 may be more absorbent than layers 222, 224, and as a result, the core 220 may be able to draw fluid or substance away from layers 222, 224. In some examples, the intermediate layer 222 may be more absorbent than the outer layer 224 in order to draw fluid or substance away from the outer layer 224. The absorbency of the distal body 202 may be influenced by the density of the material of the core 220 and / or layers 222, 224, the pore size of the core 220 and / or layers 222, 224, the density of the pores of the core 220 and / or layers 222, 224, and / or the flexibility of the material of the core 220 and / or layers 222, 224.

[0028] In some embodiments, the core 220 or one or more of the layers 222, 224 may contain a material (e.g., an ionic material) that results in the storage or recovery of exudate. In some examples, such a material may be placed in two or more of the core 220 and / or layers 222, 224, and the concentration of the material may increase as it moves inward in the direction toward the core 220. The concentration of such material may be higher in the relatively inner layers than in the relatively outer layers. In one example, the core 220 has a higher concentration than the layers 222, 224, allowing the core 220 to draw exudate from the layers 222, 224. Similarly, the intermediate layer 222 may have a higher concentration than the outer layer 224 in order to draw exudate from the outer layer 224 to the intermediate layer 222. For example, the core 220 or layers 222, 224 may contain a material comprising alginates, such as calcium alginate, sodium carboxylate, or methylcellulose. If a fluid or substance is present at the target site, such material can form a gel or, in other ways, facilitate the storage or recovery of the fluid or substance within the core 220 or layers 222, 224. For example, calcium alginate can form a gel in the presence of a fluid and can hold up to 20 times its own weight. In some examples, alginates may be in suitable forms such as beads, mixtures, bandages, electrospun scaffolds, flexible fibers, films, foams, gels, hydrogels, fine particles, microspheres, nanoparticles, polymer electrolyte complexes, powders, ropes, sheets, and / or sponges, or injectable forms.

[0029] In some cases, the storage or recovery materials listed above may be coated onto one or more of the outer surfaces of the core 220 and / or layers 222, 224, or impregnated into the core 220 and / or layers 222, 224. The use of such materials may aid in the removal of the distal body 202. These can help stop tissue bleeding (and promote wound healing) and prevent or inhibit coagulated exudate from adhering to other layers of the distal body 202. For example, alginate incorporated into the core 220 and / or layers 222, 224 can exchange fluids and ions in the treatment site when the distal body 202 is placed at the treatment site. For example, a calcium alginate nonwoven core 220 and / or layers 222, 224 can exchange sodium ions in the exudate or in the infected treatment site (e.g., wound). Such cores 220 and / or layers 222, 224 may not adhere to the wound bed but self-adhere to the healthy tissue surrounding the wound bed. Furthermore, even if alginate fibers are washed away from the wound site, newly formed tissue may not be affected.

[0030] In one example, the intermediate layer 222 may include one or more of the materials listed above, or other similar materials, that can prevent the intermediate layer 222 from adhering to the core 220 and / or the outer layer 224.

[0031] In some examples, the outer surfaces of the core 220 and / or layers 222, 224 may be lined with a non-adhesive material to help remove the distal body 202 from the body of object. Suitable materials include stretched PTFE, perforated PTFE, polyethylene, ChronoFlex C®, and / or PVDF. For example, the outer layer of outer layer 224 may include such a non-adhesive material.

[0032] The core 220 and / or one or more of the layers 222, 224 may have hydrophobic or hydrophilic properties. In some examples, the core 220 may contain a hydrophobic / non-wetting material so that a fluid or substance can flow through the opening 226 without wetting the inside of the core 220. A non-wetting core 220 can facilitate drainage through the lumen 210. In some examples, the outer layer 224 may be hydrophilic so that it can facilitate (e.g., suction) the fluid through the distal body 202. The intermediate layer 222 may be hydrophobic or hydrophilic to facilitate fluid flow. A hydrophilic material may allow the fluid to pass through the denser cellular structure of the outer layer 224 and / or the intermediate layer 222.

[0033] One or more of the core 220 or layers 222, 224 (e.g., intermediate layer 222) may contain antimicrobial or antibacterial materials such as silver particles or zinc oxide (ZnO), which may help limit and / or reduce bacterial growth at the target site. Such antimicrobial and / or antibacterial materials / agents may be placed on the surface of the core 220 or layers 222, 224, or impregnated into the core 220 or layers 222, 224. One or more layers in contact with the tissue (e.g., outer layer 224, or a portion of the core 220 or intermediate layer 222 not covered by another layer) may contain collagen or other suitable substances to promote tissue growth and structure, thereby facilitating wound healing.

[0034] In some examples, the outer layer 224 and / or intermediate layer 222 may have dense cellular porosity to prevent infiltration through the outer layer 224 and / or intermediate layer 222 into a more porous layer below (e.g., the core 220 or a porous intermediate layer 222). For example, the outer layer 224 and / or intermediate layer 222 may be formed of a fine mesh or cloth. In some examples, the outer layer 224 and / or intermediate layer 222 may contain a woven or open-cell polymer such as cellulose, such as nylon, polyester, urethane, or natural cotton fibers containing sodium sulfate. In some embodiments, the outer layer 224 and / or intermediate layer 222 may be like a sock placed around a particular area of ​​the core 220. In some examples, the area around which such a sock is placed may be the entire tissue contact area of ​​the distal body 202. In other embodiments, the outer layer 224 and / or intermediate layer 222 may completely cover the core 220. As described above, in some examples, one or more of the outer layer 224 and / or intermediate layer 222 may be hydrophilic so that fluid or material from the target site flows through the dense cellular porosity of the layer, while at the same time preventing, for example, the growth of tissue into the distal body 202. The outer layer 224 may also include projections similar to the projections 114 described above with respect to the EVAC device 100.

[0035] In some examples, a portion of the outer surface of the outer layer 224 may include a fixation / anti-movement area to prevent the distal body 202 from moving away from the target site. The fixation area may include an adhesive, be textured (e.g., a gripping structure such as a micropattern), and / or include any structure configured to adhere to a tissue wall. In some examples, the fixation area may be positioned on the outer surface of the outer layer 224 so that it contacts only healthy tissue adjacent to the target site, such as a wound. In some examples, the fixation area may be positioned on the proximal portion of the outer surface of the outer layer 224 so as to engage with healthy tissue and avoid interference with disease treatment.

[0036] In one example, the core 220 may include a highly non-wetting open-cell foam. The intermediate layer 222 may include an antimicrobial coating or be impregnated with an antimicrobial material. Alternatively, the outer surface of the core 220 may have an antimicrobial coating. The outer layer 224 may include a material having dense cellular porosity (e.g., a fine mesh) or may include a hydrophilic coating. The outer layer 224 and the intermediate layer 222 may have different cell sizes and different dispersions. The size of the openings or pores in the outer layer 224 and / or the intermediate layer 222 may, on average, be smaller than the size of the openings in the core 220. In other words, the core 220 may have a larger cell size than the intermediate layer and / or the outer layer 224. The dispersion properties of the intermediate layer 222 and the outer layer 224 may be selected to allow the fluid to move directionally through the distal body 202. Although the intermediate layer 222 and the outer layer 224 are described as separate layers, it will be understood that they may be fixed to each other or form a single layer.

[0037] The outer layer 224 and / or intermediate layer 222 may be fixed onto the core 220, and in some examples, they may be fixed onto a portion of the distal end 203 of the vacuum tube 204. In some examples, the proximal end of the outer layer 224 and / or intermediate layer 222 may include an opening 216 so that the distal end of the core 220 can be inserted into the opening 216 of the outer layer 224 and / or intermediate layer 222. The outer layer 224 and / or intermediate layer 222 can then be pulled proximal to the core 220 (or the core 220 can be moved distally within the outer layer 224) so ​​as to partially or completely cover the core 220 and optionally cover a portion of the distal end 203 of the vacuum tube 204. The outer layer 224 and / or intermediate layer 222 can then be fixed to the distal end 203 of the vacuum tube 204 by a fixing device 240. The fixation device 240 may include clips, drawstrings, elastic bodies, suture heat shrink trapping materials, and the like.

[0038] Figure 3 shows the distal end of another exemplary EVAC device 300. Figure 3 shows a cross-sectional view of the EVAC device 300. The EVAC device 300 may have any characteristics of the EVAC devices 100, 200, unless otherwise noted below. Where possible, similar reference numbers are the reference numbers associated with the EVAC device 200 plus 100. The EVAC device 300 may include a multilayer distal body 302 coupled to the distal end 303 of a vacuum tube 304. Similar to the vacuum tube 104, the vacuum tube 304 may include an outer wall 308 and a lumen 310, and the proximal end of the vacuum tube 304 may be connected to a vacuum source (not shown). The distal end 303 of the vacuum tube 304 can be attached to the distal body 302 via sutures, adhesive, or the like (including any of the mechanisms described above for EVAC devices 100, 200) such that the distal end 303 of the vacuum tube 304 is housed within the opening 342 of the main channel 328 formed in the proximal end 344 of the distal body 302, or so that the lumen 310 communicates with the channel 328. Details of the channel 328 are described below.

[0039] In some examples, the distal body 302 may include a core 320 and an outer layer 324. In Figure 3, the outer layer 324 is shown partially excised to illustrate the features of the core 320. The core 320 may have any of the characteristics of the cores 120 and 220 described above. The material of the core 320 may be polyurethane (ester and / or ether), polyvinyl alcohol, composite materials, and / or other medical-grade materials. One or more lumens / channels communicating with the lumen 310 of the vacuum tube 304 may be formed within the core 320. As shown in Figure 3, the core 320 may include channels 328, 328a, and 328b. As described above, channel 328 may be at the proximal end 344 of the core 320 and may receive the distal end 303 of the vacuum tube 304 or be otherwise coupled to communicate with the lumen 310. Channels 328a and 328b may be branches / forks of the main channel 328. Channels 328a and 328b may extend proximal from the distal end 346 of the core 320 to the proximal end 344 of the core 320. The distal ends of channels 328a and 328b may terminate proximal to the most distal end of the core 320 so that channels 328a and 328b have closed distal ends. Alternatively, channels 328a and 328b may extend completely through the distal end 346 of the core 320 so that channels 328a and 328b have open distal ends. Channels 328a and 328b may join at the proximal end 344 of the core 320 to form the main channel 328 adjacent to the lumen 310. The main channel 328 may extend through the proximal end 344 of the core 320 so that it has an open proximal end. It will be understood that the distal body 302 may contain any number of channels that merge with the main channel at the proximal end 344 of the distal body 302. The channels can be in any suitable arrangement (e.g., symmetric, asymmetric, etc.). The openings 326 may be distributed on the outer surface of the core 320 and within the core 320. The openings 326 can be of various sizes and shapes and can communicate with channels 328, 328a, and 328b.Channels 328, 328a, and 328b can be sized and shaped so as not to collapse when negative pressure is applied from the vacuum tube 304. For example, channels 328, 328a, and 328b may have relatively small diameters / widths to prevent them from collapsing. The size of channels 328, 328a, and 328b can be large / wide enough for fluid to pass through. Thus, when negative pressure is supplied to the vacuum tube 304, fluid or substance can flow from the target site through the opening 326 and through channels 328, 328a, and 328b into the lumen 310 of the vacuum tube 304. Channels 328, 328a, and 328b can increase the flow into the lumen 310 compared to a core such as core 220.

[0040] The outer layer 324 may have any of the properties of layers 222 and 224 described above. Similarly, layers 222 and 224 may have any of the properties of the outer layer 324 described below. In some examples, the outer layer 324 may be formed of a fine mesh or cloth. Similar to the outer layer 224, the material of the outer layer 324 may include woven or open-cell polymers such as cellulose, such as nylon, polyester, urethane, or natural cotton fibers containing sodium sulfate. Similar to the outer layer 224, the outer layer 324 may completely enclose or cover the core 320. In other examples, the outer layer 324 may only partially cover the core 320.

[0041] In some examples, the outer layer 324 may be formed from sections of various materials such as nylon, polyester, urethane, and / or cellulose. In some examples, the size and dispersion of openings in each section of the outer layer 324 may differ from section to section. In some examples, the sections of the outer layer 324 may be independent or interconnected. In some embodiments, the outer layer 324 may comprise multiple material layers, which may be formed from the same material or from different materials having different cell sizes and / or different dispersion properties. Similar to the outer layer 224, the outer layer 324 may be hydrophilic so that fluids or substances from the target site can flow through the small openings in the outer layer 324, while simultaneously preventing, for example, the growth of tissue into the distal body 302.

[0042] The outer layer 324, in conjunction with the core 320, can direct the fluid through the distal body 302. For example, the fluid can flow through channels 328, 328a, and 328b along the path of least resistance. The fluid can enter channels 328, 328a, and 328b from the sides (e.g., radially outward) of channels 328, 328a, and 328b through the opening 326, as indicated by the arrows in Figure 3. The fluid can enter the opening 326 through pores / openings / perforations in the outer layer 324. The fluid can also enter through the distal ends of channels 328a and 328b, and through the opening 326 at the distal end 346 of the core 320 (e.g., via the distal opening of the outer layer 324).

[0043] The cores 220, 320 and layers 222, 224, 324 of the distal bodies 202, 302 can have various hydrophilic and hydrophobic properties. For example, a preferably hydrophilic layer allows fluids or substances to flow through small openings formed in the layer, or allows fluids or substances to be drawn out from the outer layer. This increases lubrication and allows exudate to pass through the porous structure of the distal bodies 202, 302, thus preventing or inhibiting clogging of the distal bodies 202, 302. In some examples, a preferably hydrophobic layer allows fluids or substances to flow through openings in the layer without wetting the inside of the layer. In some examples, cores 220, 320 may have a larger open-cell / pore structure and / or a looser open-cell structure than layers 222, 224, 324, thereby allowing more fluid or material to flow into the lumens 210, 310 through the openings 226, 326 when negative pressure is supplied to the lumens. The larger open-cell and / or looser open-cell structure of cores 220, 320 may reduce the pressure gradient across the thickness of the distal bodies 202, 302 and / or allow for greater compression of the distal bodies 202, 302 during delivery to the target site. In some examples, layers 222, 224, 324 may have a higher rigidity and / or a smaller pore size than cores 220, 320 to optimize granulation tissue formation and / or control tissue endoplasia. Alternatively, layers 222, 224, and 324 may be flexible to allow the distal bodies 202 and 302 to fit into smaller (e.g., finer) irregular spaces. It will be understood that the distal bodies 202 and 302 may include any combination of the cores 220 and 320 and layers 222, 224, and 324 described above to reduce the number of replacements of the distal bodies 202 and 302 during EVAC procedures and to improve EVAC procedures in other ways.

[0044] It will be apparent to those skilled in the art that various modifications and changes can be made to the disclosed devices without departing from the scope of this disclosure. Other aspects of this disclosure will be apparent to those skilled in the art from the examination of this specification and the practice of the features disclosed herein. Specifications and examples are intended to be considered for illustrative purposes only.

Claims

1. It is a medical device, It includes a distal body connected to the distal end of the vacuum tube, the distal body is in communication with the lumen of the vacuum tube, and the distal body is A core including multiple openings, A medical device comprising one or more layers surrounding the core.

2. The medical device according to claim 1, wherein at least one of the one or more layers defines a plurality of openings.

3. The medical device according to claim 2, wherein the plurality of openings in one or more layers have an average size smaller than the average size of the plurality of openings in the core.

4. The medical device according to any one of claims 1 to 3, wherein the one or more layers completely enclose the core.

5. The medical device according to any one of claims 1 to 4, wherein the one or more layers surround only a portion of the core.

6. The medical device according to any one of claims 1 to 5, wherein one or more of the aforementioned layers are coated with an antimicrobial material.

7. The medical device according to any one of claims 1 to 6, wherein at least one of the one or more layers is connected to the distal end of the vacuum tube via a clip, a drawstring, or a suture.

8. The medical device according to any one of claims 1 to 7, wherein at least one of the one or more layers includes one or more protrusions extending radially outward from the outer surface of at least one of the one or more layers.

9. The medical device according to any one of claims 1 to 8, wherein the one or more layers include a first layer surrounding the core and a second layer surrounding the first layer.

10. The medical device according to claim 9, wherein the absorbency of the second layer is greater than that of the first layer, and the absorbency of the first layer is greater than that of the core.

11. The medical device according to claim 9, wherein the core comprises a hydrophobic material, and the first and second layers comprise a hydrophilic material.

12. The medical device according to claim 9, wherein the proximal portion of the outer surface of the second layer includes an adhesive.

13. The medical device according to any one of claims 1 to 12, wherein one or more of the aforementioned layers are coated with a material containing alginate.

14. The medical device according to any one of claims 1 to 13, wherein the core includes a first channel and a second channel, the first channel and the second channel extending from the proximal end of the core to the distal end of the core, and the distal ends of the first channel and the second channel each terminate proximal to the most distal end of the core.

15. The medical device according to claim 14, wherein the first channel and the second channel join at the proximal end of the core to form a third channel.

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