Endoluminal treatment device

Abstract

Medical devices and related methods are described, including medical devices comprising a tubular assembly comprising a plurality of tubes. Each tube of the plurality of tubes can be configured to be coupled to a vacuum source to deliver negative pressure to a distal end of each respective tube of the plurality of tubes. The medical devices can also comprise a multiwell assembly comprising a plurality of segments and can be coupled to a distal end of the tubular assembly. Each segment of the plurality of segments can be coupled to a respective tube of the plurality of tubes.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 582,954, filed September 15, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention relates generally to minimally invasive medical devices and methods. In particular, aspects of the present invention relate to medical devices and methods for endoscopic medical procedures, such as closing wounds or otherwise treating tissues. Background Technology

[0003] Endoscopic and open surgical procedures of the gastrointestinal tract (GI) include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in GI tract perforation, postoperative anastomotic leakage, or other wounds. Patients with GI tract perforation, postoperative anastomotic leakage, and / or other wounds have a high mortality rate and limited treatment options. Options include endoscopic placement of clips or stents, endoscopic sutures or sealants, or reoperation. The procedures are relatively invasive and have high morbidity and mortality rates. While endoscopic stent placement is a low-invasive option, stents may migrate from their intended location and / or isolate infection at the treatment site, thus inhibiting drainage.

[0004] The medical device and method of the present invention can correct some of the above-mentioned defects or solve other aspects of the technology. Summary of the Invention

[0005] According to some aspects of the invention, a medical device may include a tubular assembly comprising a plurality of tubes. Each of the plurality of tubes may be configured to be coupled to a vacuum source to deliver negative pressure to a distal end of a corresponding tube in the plurality of tubes. The medical device may also include a porous assembly comprising a plurality of segments. The porous assembly may be coupled to a distal end of the tubular assembly, and each of the plurality of segments may be coupled to a corresponding tube in the plurality of tubes.

[0006] According to some aspects, each tube in a plurality of tubes may include one or more walls defining a channel for delivering negative pressure to a segment of a plurality of segments corresponding to the channel. In some examples, a first channel of the innermost tube in the plurality of tubes may extend from the proximal end to the distal end of the innermost tube. In some examples, the central longitudinal axis of the medical device may extend through the first channel. In some examples, a second channel of the outermost tube in the plurality of tubes may extend from the proximal end to the distal end of the outermost tube in the plurality of tubes. In some examples, the second channel extends radially about the central longitudinal axis of the medical device. In some examples, each segment of the plurality of segments may include an opening in fluid communication with the channel of the corresponding tube in the plurality of tubes, and the opening of each segment of the plurality of segments may be independent of the openings of the other segments of the plurality of segments. In some examples, the channel of each tube in the plurality of tubes may have a proximal opening end and a distal opening end, and the proximal opening end of the channel may be coupled to a vacuum source, and the distal opening end may be coupled to the proximal end of the corresponding segment of the plurality of segments. In some examples, the plurality of segments may be configured to be individually removed from a target site within a body cavity. In some examples, the outermost tube in a plurality of tubes may be connected to the outermost segment of a plurality of segments, and proximal movement of the outermost tube relative to the other tubes in the plurality of tubes may cause the outermost segment of the plurality of segments to retract above the remaining segments of the plurality of segments. In some examples, the plurality of tubes may be configured to deliver negative pressure to only one segment of the plurality of segments at a time. In some examples, each segment of the plurality of segments may include an inner surface and an outer surface, and the outer surface of each segment of the plurality of segments may include one or more of a rough portion and a coating, the rough portion being used to collect exudate from a target site, and the coating being used to prevent tissue ingrowth. In some examples, each segment of the plurality of segments may include a cap located at the distal end of each segment of the plurality of segments. In some examples, the diameter of the distal end of each tube in the plurality of tubes may be aligned with the diameter of the proximal end of the corresponding segment of the plurality of segments. In some examples, the porous component may include at least four segments, and the tubular component may include at least four tubes, with a first segment connected to a first tube, a second segment connected to a second tube, a third segment connected to a third tube, and a fourth segment connected to a fourth tube. In some examples, the first segment may be cylindrical, the second segment may extend around the first segment, the third segment may extend around the second segment, and the fourth segment may extend around the third segment. In some examples, the first tube may be nested within the second tube, the second tube may be nested within the third tube, and the third tube may be nested within the fourth tube.

[0007] According to some aspects of the invention, a medical device may include a tubular assembly comprising at least two tubes. Each tube in the tubular assembly may include a channel, and each channel may be configured to be coupled to a vacuum source to deliver negative pressure to the distal end of each tube independently of the other channels. The medical device may also include a porous assembly comprising at least two segments and coupled to the distal end of the tubular assembly. Each segment in the porous assembly may be coupled to a corresponding channel of the at least two tubes. In some examples, the outermost tube of the at least two tubes may be coupled to the outermost segment of the at least two segments, and proximal movement of the outermost tube relative to the innermost tube of the at least two tubes may cause the outermost segment of the at least two segments to move proximally above and above the innermost tube of the at least two segments. In some examples, the channel of the innermost tube of the at least two tubes may be cylindrical, and the channel of the outermost tube may extend radially about the central longitudinal axis of the medical device.

[0008] According to some aspects of the invention, a medical device may include a tubular assembly comprising a plurality of tubes nested within each other. Each of the plurality of tubes may be configured to be coupled to a vacuum source to deliver negative pressure to a distal end of each tube. The medical device may also include a porous assembly comprising a plurality of segments nested within each other and coupled to the distal end of the tubular assembly. The proximal end of each of the plurality of segments may be coupled to the distal end of a corresponding tube in the tubular assembly. In some examples, each of the plurality of tubes may be configured to independently deliver negative pressure to a corresponding segment of the plurality of segments. Attached Figure Description

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0010] Figure 1A The distal portion of an exemplary medical device is depicted in the first stage of use at a target site according to some aspects of the present invention.

[0011] Figure 1B According to some aspects of the present invention Figure 1A An enlarged view of the distal portion of the medical device.

[0012] Figure 1C Depicting some aspects of the invention Figure 1A The remote end of the medical device.

[0013] Figure 1D Depicting some aspects of the invention Figure 1A The proximal end of the medical device.

[0014] Figure 1EThe second stage of use at the target site according to some aspects of the invention is depicted. Figure 1A The remote part of the medical device.

[0015] Figure 1F The third stage of use at the target site according to some aspects of the invention is described. Figure 1A The remote part of the medical device.

[0016] Figure 1G Depicting some aspects of the invention Figure 1A An exemplary handle for a medical device. Detailed Implementation

[0017] Specific aspects of the invention are described in more detail below. In the event of any conflict with terms and / or definitions incorporated by reference, the terms and definitions provided herein shall prevail.

[0018] The terms “proximal” and “distal” are used herein to refer to the relative positions of components of the exemplary medical device. As used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to the operator using the medical device. Conversely, “distal” refers to a position relatively further away from the operator using the medical device or closer to the interior of the body.

[0019] As used herein, the terms “comprising,” “including,” “having,” 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 “model.”

[0020] In addition, relative terms such as “approximately,” “roughly,” and “about” are used to indicate possible variations of ±10% in a specified value or range.

[0021] Endocavitary vacuum therapy (EVT or EVAC, and referred to herein as EVAC) is a procedure for treating wounds, such as postoperative leaks or perforations in the gastrointestinal tract (GI) following surgical or endoscopic procedures, such as colectomy, bariatric surgery, or esophagectomy. In EVAC, negative pressure is delivered to the wound site within the GI tract, for example, via a nasogastric tube having a sponge-like material (e.g., Granufoam™ sponge) or foam (e.g., vacuum-sealed foam) sutured to its distal end. The proximal end of the tube may be connected to a collection container. The foam is placed endoscopically into the perforation, leak, or other wound. In some examples, EVAC involves endocavitary placement of foam or other similar material into wound (e.g., target) sites, including perforations, leaks, cysts, anastomoses, etc. The placement of the material can be achieved via a catheter, endoscope (endoscope, bronchoscope, colonoscope, duodenoscope, gastroscope, etc.), tube, or sheath inserted through a natural orifice into the GI tract. The opening can be, for example, the nose, mouth, or anus, and can be placed in any part of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine.

[0022] A rat-tooth forceps or another accessory device can extend through the working channel of the endoscope and be used to guide the foam to the wound site as the endoscope is navigated. Material placement can also be performed in other organs accessible via the GI channel, such as the colon. Negative pressure is then applied. The foam in the wound, along with the negative pressure, can accelerate healing by promoting local granulation tissue formation at the wound site. As the wound heals and closes, the foam can be replaced with foam of gradually decreasing size. Existing devices and systems suitable for EVAC are limited. For example, EVAC typically requires foam replacement every 3 to 5 days to prevent ingrown tissue.

[0023] Various aspects of the present invention include apparatus and methods for reducing the frequency of foam replacements and / or eliminating the need for foam replacements and / or device replacements during EVAC. Components of the apparatus described herein can be packaged as kits for EVAC. For example, the apparatus disclosed herein may include a porous assembly coupled to a distal end of a tubular assembly. The porous assembly may include multiple porous layers or porous segments that are independent of each other. In some aspects, each porous layer or porous segment may include a coating for preventing tissue ingrown growth, an end cap, and / or a roughened portion on the outer surface of each porous layer or porous segment for storing and / or collecting exudate from the target site. In some aspects, the tubular assembly may include multiple coaxial tubes, and each tube may be coupled to a corresponding porous layer or porous segment. In some aspects, each tube may include a channel configured to deliver negative pressure to its corresponding porous layer or porous segment, the channels being independent or separated from each other. In some aspects, each porous layer or porous segment may be sequentially removed from the target site, starting with the outermost porous layer or porous segment, by withdrawing its corresponding tube.

[0024] Reference will now be made in detail to the examples of the invention described above and shown in the accompanying drawings. Where possible, the same reference numerals will be used in all the drawings to refer to the same or similar parts.

[0025] Figure 1A A cross-sectional view of the distal portion of an EVAC device 100 is shown. The EVAC device includes a porous or foam assembly 104, which can be inserted into a patient to aid in the healing of wounds, anastomoses, etc., or otherwise treat tissue, as described above. Although the EVAC device 100 is shown at a wound site or target site 170 (e.g., anastomosis) within a GI tract, it should be understood that the use of the EVAC device 100 is not limited to the GI tract and can be used in any internal body cavity to treat wounds, leaks, perforations, etc. The foam assembly 104 may be generally cylindrical and coupled to a tubular assembly 116. The central longitudinal axis A of the EVAC device 100 may be aligned with the central longitudinal axis of the foam assembly 104 and the central longitudinal axis of the tubular assembly 116 (in... Figure 1A All are shown aligned with axis A. Foam assembly 104 may include multiple foam layers or foam segments 104d, 104c, 104b, 104a.

[0026] Figure 1C The distal side 111 of the distal end 112 of the foam assembly 104 is shown, which does not have end caps 106d, 106c, 106b, 106a, as described in more detail below. The core foam or central segment 104d may be generally cylindrical (e.g., a solid cylinder), and each of the other segments 104c, 104b, 104a may extend radially around the central segment 104d, thereby forming a coaxial, generally tubular cylindrical layer or segments 104c, 104b, 104a nested together. As will be discussed in more detail below, segments 104a, 104b, 104c, 104d may be removed one at a time from the target site 170 during the treatment process and as the target site 170 heals (i.e., shrinks). Therefore, when segments 104a, 104b and / or 104c are removed, the diameter of foam assembly 104 can be reduced to accommodate wound sizes at different healing stages.

[0027] Each segment 104d, 104c, 104b, 104a may extend longitudinally in the direction of the central longitudinal axis A. In a cross-section perpendicular to the central longitudinal axis A, segment 104d may have a solid circular shape, while segments 104a, 104b, and 104c may have an annular shape. In some examples, segments 104d, 104c, 104b, 104a may have the same thickness measured in the direction perpendicular to the central longitudinal axis A (i.e., the radial direction), and segments 104d, 104c, 104b, 104a may have the same length measured parallel to the central longitudinal axis A (i.e., the axial direction). In other examples, segments 104d, 104c, 104b, 104a may have different thicknesses and / or lengths. When adjacent segments exist (and are not removed), the radial inner surface of each segment 104c, 104b, 104a can contact the radial outer surface of the adjacent segments 104d, 104c, 104b, respectively.

[0028] Each segment 104d, 104c, 104b, 104a can be independent of each other, and each segment 104c, 104b, 104a can be configured to move above the remaining segments of the foam assembly 104. Each segment 104c, 104b, 104a can be configured to move above / alongside and relative to one or more of segments 104d, 104b, 104c. For example, segment 104a can be configured to move above and proximal to segments 104b, 104c, 104d; segment 104b can be configured to move above and proximal to segments 104c, 104d; and segment 104c can be configured to move above and proximal to segment 104d. This allows for the sequential removal of segments 104d, 104c, 104b, and 104a from the target site 170 during treatment, starting from the outermost or most lateral segment (e.g., layer or segment 104a) from the central longitudinal axis A. Alternatively, other removal techniques may be employed (e.g., one or more of segments 104a, 104b, and / or 104c may include perforations or other features to facilitate removal). For example, segment 104a may be removed on day 4, segment 104b on day 8, segment 104c on day 12, and segment 104d on day 16. The timelines provided above are merely exemplary, and any suitable timeline (including oriented patient timelines) may be utilized.

[0029] The dimensions of the foam assembly 104 (including segments 104d, 104c, 104b, 104a) can depend on, for example, the dimensions of the wound or target site. Although the EVAC device 100 is shown as having four segments 104d, 104c, 104b, 104a, it should be understood that the foam assembly 104 may include any number of segments or layers, for example at the start of treatment, and the number of segments or layers may depend on, for example, the expected duration of treatment and / or the dimensions of the wound or target site. The operator may optionally remove one or more of segments 104a, 104b, 104c before initial delivery to customize the dimensions of the foam assembly 104. It should be understood that the foam assembly 104 (including segments 104d, 104c, 104b, 104a) can be of any shape, including spherical, cuboid, irregular, etc.

[0030] Segments 104d, 104c, 104b, and 104a may have any characteristics of any foam known in the art for use in EVAC procedures. For example, segments 104d, 104c, 104b, and 104a may include open-cell foam. Segments 104d, 104c, 104b, and 104a may include openings 105d, 105c, 105b, and 105a on their outer surface and / or interior, respectively. Although Figure 1A For ease of illustration, each segment 104d, 104c, 104b, 104a is depicted as having only one opening 105d, 105c, 105b, 105a. However, it should be understood that each segment 104d, 104c, 104b, 104a may include multiple openings 105d, 105c, 105b, 105a having any suitable shape, size, or location. Openings 105d, 105c, 105b, 105a can be any hole, aperture, or channel. Openings 105d, 105c, 105b, 105a may include interconnecting channels and / or apertures respectively penetrating segments 104d, 104c, 104b, 104a. For example, openings 105d, 105c, 105b, 105a can be apertures in segments 104d, 104c, 104b, 104a, respectively. Openings 105d, 105c, 105b, and 105a may have different sizes and / or shapes. Features of openings 105d, 105c, 105b, and 105a (e.g., the size and shape of the orifices in segments 104d, 104c, 104b, and 104a) may be selected based on the location of treatment within the body, the nature of the wound to be treated, the stage of treatment, or other factors.

[0031] Segments 104d, 104c, 104b, and 104a may comprise any suitable biocompatible material that can absorb fluids and / or allow fluids or other materials to pass through them, for example, through negative pressure applied to segments 104d, 104c, 104b, and 104a. The material of segments 104d, 104c, 104b, and 104a may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. Suitable materials include polyurethanes, esters, ethers, composites, and / or other medical-grade materials.

[0032] like Figure 1A As shown, the inner surfaces 140, 138, and 136 of segments 104c, 104b, and 104a may be coated with material and / or include barriers to prevent fluid and / or other materials from the target portion 170 from passing through the outermost segment, such as segment 104a, and entering the inner segments, such as segments 104b, 104c, and 104d, when, for example, a negative pressure is applied to the outermost segment, such as segment 104a. The material may include polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), high-density polyethylene (HDPE), and / or thermoplastic elastomer (TPE). The coating material on the inner surfaces 140, 138, and 136 of segments 104c, 104b, and 104a may isolate segments 104d, 104c, 104b, and 104a from each other, including openings 105d, 105c, 105b, and 105a. When the outer surfaces 148, 146, 144, and 142 of segments 104d, 104c, 104b, and 104a are exposed to the target portion 170, the outer surfaces 148, 146, 144, and 142 of segments 104d, 104c, 104b, and 104a can allow fluid and / or other materials from the target portion 170 to pass through segments 104d, 104c, 104b, and 104a. For example, when segment 104a is removed from the target portion 170, the outer surface 144 of segment 104b can be exposed to the target portion 170, and fluid and / or materials from the target portion 170 can pass through segment 104b (e.g., when segment 104a is removed from the target portion 170). Figure 1F As shown), due to the coating material on the inner surface 138 of section 104b, fluids and / or materials cannot pass through sections 104c and 104d.

[0033] Each segment 104a, 104b, 104c, 104d may include end caps 106a, 106b, 106c, 106d, rough portions 108a, 108b, 108c, 108d, and / or foam coatings 110a, 110b, 110c, 110d, respectively. Although reference will now be made to end caps 106a, rough portions 108a, and foam coatings 110a, it should be understood that end caps 106b, 106c, 106d may have the same or similar properties as end cap 106a; rough portions 108b, 108c, 108d may have the same or similar properties as rough portion 108a; and foam coatings 110b, 110c, 110d may have the same or similar properties as foam coating 110a.

[0034] End cap 106a may be removably attached to the farthest side of segment 104a. For example, end cap 106a may be attached to the farthest side of segment 104a via an adhesive. The material of end cap 106a may include ePTFE, PTFE, HDPE, and / or TPE. End cap 106a may help retain fluid and / or material from target portion 170 within segment 104a during removal of segment 104a from target portion 170. For example, end cap 106a may prevent fluid and / or material within segment 104a from leaking out from the farthest side of segment 104a during removal of segment 104a from target portion 170. End cap 106a may also prevent fluid and / or material from target portion 170 from entering segment 104a from the farthest side of segment 104a.

[0035] The outer surface 142 of segment 104a may include a roughened portion 108a at the distal end of segment 104a or at another suitable location of segment 104a. The roughened portion 108a may be configured to collect and / or store exudate from target site 170. The roughened portion 108a of the outer surface 142 may extend entirely around the circumference of segment 104a (e.g., forming an annular roughened portion 108a on the outer surface 142), or partially around the circumference of segment 104a (e.g., forming a sheet-like roughened portion 108a). Although the roughened portion 108a is shown at the distal end of segment 104a, it should be understood that the roughened portion 108a may be located at any location along the outer surface 142 (or other portion) of segment 104a.

[0036] The outer surface 142 of segment 104a may include a foam coating 110a at the central portion of segment 104a. The foam coating 110a of the outer surface 142 may extend completely around the circumference of segment 104a, for example, forming an annular foam coating 110a on the outer surface 142. Alternatively, the foam coating 110a may extend only partially around segment 104a (similar to a patch). Although the foam coating 110a is shown at the central portion of segment 104a, it should be understood that the foam coating 110a may be positioned anywhere along the outer surface 142 of segment 104a. The foam coating 110a may be configured to prevent or inhibit inward tissue growth into segment 104a. The material of the foam coating 110a may include PTFE, silicone, polyvinylidene fluoride (PVDF), and / or HDPE. For example, as Figure 1E As shown, as the target area 170 shrinks (i.e., as the wound heals), the tissue T at the target area 170 can contact the outer surface 142 of the segment 104a and compress the segments 104a, 104b, 104c, and 104d, but due to the foam coating 110a, the tissue T may not grow into the segments 104a, 104b, 104c, and 104d.

[0037] Figure 1B This is an enlarged cross-sectional view of the proximal end 114 of the foam assembly 104 and the distal end 150 of the tubular assembly 116. The proximal end 114 of the foam assembly 104 may be coupled to the distal end 150 of the tubular assembly 116. The tubular assembly 116 may include multiple coaxial tubes 116a, 116b, 116c, 116d nested among each other. For example, tube 116a (e.g., the outermost tube) may surround tubes 116b, 116c, 116d, tube 116b may surround tubes 116c, 116d, and tube 116c may surround tube 116d (e.g., the innermost tube). The tubular assembly 116 may be and / or form, for example, a nasogastric tube. In the example, each tube 116a, 116b, 116c, 116d may be thin-walled and composed of coils and a polymer covering. Alternatively, tubes 116a, 116b, 116c, and 116d may have any other suitable properties and may be made of any suitable material.

[0038] Tubes 116a, 116b, 116c, and 116d can be fixedly connected to segments 104a, 104b, 104c, and 104d, respectively. The proximal ends of segments 104a, 104b, 104c, and 104d can be attached to the distal ends of tubes 116a, 116b, 116c, and 116d, respectively, via sutures or other ties, adhesives, shrink wrapping materials, elastic elements, etc. In the relaxed state of foam assembly 104, the proximal end 114 of foam assembly 104 can be narrower than the distal end 112 of foam assembly 104 to facilitate, for example, connecting the proximal ends of segments 104a, 104b, 104c, and 104d to the distal ends of tubes 116a, 116b, 116c, and 116d, respectively. The diameter of the distal end of each tube 116a, 116b, 116c, 116d may correspond to or otherwise align with the diameter of the proximal end of each segment 104a, 104b, 104c, 104d to form a one-to-one pairing / connection between tubes 116a, 116b, 116c, 116d and segments 104a, 104b, 104c, 104d. In some examples, the foam assembly 104 may be compressed during transport (e.g., within a transport jacket) such that the distal end 112 has a similar diameter to the proximal end 114 during transport.

[0039] Each tube 116a, 116b, 116c, 116d can be configured to deliver negative pressure independently of each other via channels within each tube 116a, 116b, 116c, 116d. For example... Figure 1B As shown, the distal ends of pipes 116a, 116b, 116c, and 116d can be aligned with the proximal ends of segments 104a, 104b, 104c, and 104d, respectively. This allows negative pressure to be applied to segments 104a, 104b, 104c, and 104d individually. For example, pipe 116a can apply negative pressure to segment 104a, pipe 116b can apply negative pressure to segment 104b, pipe 116c can apply negative pressure to segment 104c, and pipe 116d can apply negative pressure to segment 104d.

[0040] Figure 1D The proximal end 152 of the tubular assembly 116 is shown. The tube 116a may include an outer wall 120a, an inner wall 120b, and a cavity / channel 122 disposed between the walls 120a and 120b. Therefore, the tube 116a may consist of two tubular walls 120a and 120b, which may be concentric with each other (e.g., around a central longitudinal axis A). The channel 122 extends from... Figure 1D The proximal end 152 of the tube 116a shown extends to Figure 1BThe distal end 150 of tube 116a is shown. Channel 122 may extend radially about the central longitudinal axis A of EVAC device 100. The cross-section of channel 122 perpendicular to the central longitudinal axis A may have an annular (ring) shape. Channel 122 may have an open proximal end and a closed distal end. The open proximal end may be coupled to a vacuum source (not shown), and the open distal end may be coupled to the proximal end of segment 104a. Thus, the opening 105a of segment 104a may be in fluid communication with the open distal end of channel 122 of tube 116a. The vacuum source may supply negative pressure to segment 104a via the open distal end of channel 122. For example, a negative pressure of approximately 125 mmHg or approximately 2.5 pounds per square inch (PSI) may be supplied to segment 104a via channel 122 of tube 116a. Other suitable amounts of negative pressure may be used. Negative pressure can draw fluids, materials and / or other debris into the channel 122 of the tube 116a through the opening 105a of the segment 104a, which can promote healing of the target site 170.

[0041] Unless otherwise stated herein, tubes 116b and 116c may have properties similar to those of tube 116a. Tube 116b may include an outer wall 124a, an inner wall 124b, and a cylindrical cavity / channel 126 disposed between the walls 124a and 124b and configured to apply negative pressure to segment 104b. An opening 105b of segment 104b may be in fluid communication with the channel 126 of tube 116b such that when negative pressure is supplied to the channel 126, the negative pressure may draw fluid, material, and / or other debris from target portion 170 into the channel 126 of tube 116b via the opening 105b when segment 104b is exposed to target portion 170 (e.g., when segment 104a is removed). The tube 116c may similarly include an outer wall 128a, an inner wall 128b, and a cylindrical cavity / channel 130 disposed between the walls 128a and 128b and configured to apply negative pressure to the segment 104c. The opening 105c of the segment 104c may be in fluid communication with the channel 130 of the tube 116c, such that when negative pressure is supplied to the channel 130, the negative pressure may draw fluid, material, and / or other debris from the target portion 170 into the channel 130 of the tube 116c via the opening 105c when the segment 104c is exposed to the target portion 170 (e.g., when segments 104a and 104b are removed).

[0042] The tube 116d may include a wall 132 defining a central cylindrical cavity / channel 134. Channel 134 from... Figure 1D The proximal end of the tube 116d shown extends to Figure 1BThe distal end of tube 116d is shown. The central longitudinal axis A of the EVAC device 100 may extend through the central channel 134 of tube 116d. Similar to channels 122, 126, and 130, channel 134 may have an opening at both a proximal and distal end. The opening 105d of segment 104d may be in fluid communication with the channel 134 of tube 116d, such that when negative pressure is supplied to channel 134, the negative pressure may draw fluid, material, and / or other debris from target portion 170 into the channel 134 of tube 116d via the opening 105d.

[0043] In some examples, the inner surface of each tube 116a, 116b, 116c can contact the outer surface of the adjacent tubes 116b, 116c, 116d, respectively. The inner wall 120b of tube 116a can contact the outer wall 124a of tube 116b, the inner wall 124b of tube 116b can contact the outer wall 128a of tube 116c, and the inner wall 128b of tube 116c can contact the wall 132 of tube 116d.

[0044] Each tube 116a, 116b, 116c can be configured to move above the remaining tubes in the tubular assembly 116. Each tube 116a, 116b, 116c can be configured to move above / alongside and relative to one or more of tubes 116b, 116c, 116d. For example, tube 116a can be configured to move above / alongside and proximal to tubes 116b, 116c, 116d to retract segment 104a from target portion 170, tube 116b can be configured to move above / alongside and proximal to tubes 116c, 116d to retract segment 104b from target portion 170, and tube 116c can move above and proximal to tube 116d to retract segment 104d from target portion 170. For example, the wall 120b of pipe 116a (or the inner surface of pipe 116a) can slide along the wall 124a of pipe 116b (or the outer surface of pipe 116b), the wall 124b of pipe 116b (or the inner surface of pipe 116b) can slide along the wall 128a of pipe 116c (or the outer surface of pipe 116c), and the wall 128b of pipe 116c (or the inner surface of pipe 116c) can slide along the wall 132 of pipe 116d (or the outer surface of pipe 116d). For example, lubricating material or air gaps can exist between adjacent pipes 116a, 116b, 116c, and 116d to facilitate the removal of one or more pipes.

[0045] In an alternative, inner walls 120b, 124b, and 128b can be omitted. Tubes 116a, 116b, and 116c may comprise single tubular walls 120a, 124a, and 128a. Walls 120a, 124a, and 128a may be fixed to the radially outermost portions of segments 104a, 104b, and 104c, respectively. The space / gap between wall 120a and wall 124a may define channel 122. The space between wall 124a and wall 128a may define channel 126. The space between wall 128a and wall 132 may define channel 130. Because walls 120a, 124a, and 128a can be fixed to the outermost radial portions of segments 104a, 104b, and 104c, channels 122, 126, and 130 can provide suction only to segments 104a, 104b, and 104c, respectively, and not to other segments. Because of the space / gap between walls 120a, 124a, 128a, and 132, pipes 116a, 116b, and 116c can be removed, as discussed above.

[0046] It should be understood that the number of tubes in the tubular assembly 116 depends on the number of segments or layers in the foam assembly 104. The EVAC device 100 may include any number of segments or layers (and any corresponding number of tubes), which may depend on, for example, the expected duration of treatment and / or the size of the wound or target site. For example, the EVAC device 100 may include at least two segments or layers and at least two tubes.

[0047] EVAC unit 100 may include an outer casing 118 ( Figure 1A The outer tube 118 can extend over the tubular assembly 116 and the foam assembly 104 during delivery of the EVAC device 100. The outer tube 118 facilitates movement of the EVAC device 100 through the working channel of an endoscope or other medical device. For example, the outer tube 118 can compress the foam assembly 104 into a smaller profile during insertion into the target site 170. Proximal movement of the outer tube 118 relative to the EVAC device 100 can cause the foam assembly 104 to expand during positioning within the target site 170. For example, the foam assembly 104 can have shape memory properties, allowing it to expand to a natural, relaxed shape after the outer tube 118 is withdrawn.

[0048] Figure 1GAn exemplary handle 102 of an EVAC device 100 is shown, configured to be coupled to a tubular assembly 116. The handle 102 is shown with a portion of a housing 103 removed to reveal internal features of the handle 102. The housing 103 may define an internal cavity 101 to movably receive the tubular assembly 116. A proximal end of the housing 103 may define a first opening 107a, and a distal end of the housing 103 may define a second opening 107b. Each of the first opening 107a and the second opening 107b may be in fluid communication with the cavity 101. The tubular assembly 116 may slidably extend through the first opening 107a and the second opening 107b.

[0049] The handle 102 may include a first wheel 172 and a second wheel 174, and each wheel 172, 174 may be configured to rotate within a corresponding slot formed on opposite sides of the housing 103. Each wheel 172, 174 may extend from outside the corresponding slot into the interior of the cavity 101. Each wheel 172, 174 may contact the outer surface of the tubular assembly 116 (e.g., the outer surface of the outermost tube (e.g., tube 116a)). The handle 102 may also include a belt 176 extending from the first wheel 172 (e.g., axle A of the first wheel 172) to the second wheel 174 (e.g., axle B of the second wheel 174). The belt 176 may apply tension (inward force) to the first wheel 172 and the second wheel 174 to maintain frictional engagement between each of the first wheel 172 and the second wheel 174 and the tubular assembly 116.

[0050] Round 172 and Round 174 are in the forward or far-toward direction (i.e., in...) Figure 1G The first round 172 in the view is counterclockwise and in Figure 1G Rotation of the second wheel 174 (clockwise in the view) causes the outermost tube of the tubular assembly 116 (e.g., tube 116a) to move rearward or proximal relative to the inner tubes of the tubular assembly 116 (e.g., tubes 116b, 116c, 116d). For example, friction between the outer surface of the outermost tube and the first wheel 172 (and between the outer surface of the outermost tube and the second wheel 174) causes the first wheel 172 and the second wheel 174 to clamp the outer surface of the outermost tube, causing the outermost tube to move proximal relative to the inner tube. In some examples, wheels 172 and 174 may move in opposite directions to move the outermost tube relative to the inner tube.

[0051] After the outermost tube (e.g., tube 116a) has been retracted proximally and removed, belt 176 can apply tension (inward force) to wheels 172, 174, causing wheels 172, 174 to frictionally engage the tube that is now the outermost tube (e.g., tube 116b). In this way, subsequent (gradually inward) tubes can be moved proximally and removed, as discussed in the method below.

[0052] Although handle 102 is shown with two wheels 172, 174, it should be understood that handle 102 may include only one wheel to move the tubes 116a, 116b, 116c of tubular assembly 116 proximally above the remaining tubes in tubular assembly 116. Wheels 172, 174 may move individually, or may be configured such that when an operator contacts one of wheels 172, 174, both wheels move together. For example, an operator may contact and rotate one of wheels 172, 174, and the other wheel 172, 174 may be passively moved due to the frictional force exerted by tubular assembly 116 on the other wheel 172, 174.

[0053] An exemplary method of using EVAC device 100 will now be described. Figure 1A , Figure 1E and Figure 1F A cross-sectional view of an EVAC device 100 for treating a target site 170 (e.g., wound, leakage, etc.) within a patient's body cavity (e.g., part of the GI tract) is shown. To position the EVAC device 100 at the target site 170, a user can insert an endoscope (or other medical device) into the patient's body through a natural orifice and position the endoscope adjacent to the target site 170. The EVAC device 100 may be provided with an outer sheath 118 positioned on a foam assembly 104. Alternatively, the user can place the outer sheath 118 onto the EVAC device 100. The user can insert the outer sheath 118, together with the EVAC device 100, into the working channel of the endoscope. The user can move the outer sheath 118, together with the EVAC device 100, distally through the working channel. With the distal portion of the endoscope positioned adjacent to the target site 170, the user can move the outer sheath 118, together with the EVAC device 100, distally out of the working channel and position the foam assembly 104 within the target site 170. The outer tube 118 can then be moved proximally (retracted) to expand the foam assembly 104 within the target site 170 and expose a segment 104a of the foam assembly 104 to the target site 170. The outer tube 118 can then be removed from the patient.

[0054] The user can then activate a vacuum source (not shown) to supply negative pressure to segment 104a through channel 122 of tube 116a, which can draw fluid, material, and / or other debris from target site 170 into channel 122 of tube 116a and / or pull a portion of target site 170 toward foam assembly 104. The endoscope can be removed, and the user can then leave the foam assembly 104 and tubular assembly 116 positioned in the patient's body for an appropriate duration (e.g., 3-5 days).

[0055] As the target area 170 heals, it can shrink and become smaller, such as Figure 1E As shown. The size of foam assembly 104 may no longer fit the adjusted size of target portion 170, and the user can remove segment 104a of foam assembly 104 from EVAC device 100 to fully match the adjusted size of target portion 170. The user can first disconnect tube 116a of tubular assembly 116 from the vacuum source. Then, the user can, for example, rotate the first wheel 172 and the second wheel 174 of handle 102 in a distal direction to retract tube 116a above tubes 116b, 116c, 116d, so that segment 104a moves proximally above segments 104b, 104c, 104d and above tubes 116b, 116c, 116d. Segment 104a and tube 116a can be removed from the patient, while segments 104b, 104c, 104d and tubes 116b, 116c, 116d remain within the target site 170, such as Figure 1F As shown. As discussed above, after removing tube 116a, the first wheel 172 and the second wheel 174 of handle 102 can engage tube 116b.

[0056] The user can then reconnect the vacuum source to tube 116b and activate the vacuum source to supply negative pressure to segment 104b, which can draw fluid, material, and / or other debris from target site 170 into the channel 126 of tube 116b and / or draw a portion of target site 170 toward foam assembly 104. Segments 104b, 104c, 104d and tubes 116b, 116c, 116d can remain in the patient for an appropriate duration (e.g., an additional 3-5 days).

[0057] As the target site 170 continues to heal, it can continue to shrink and become smaller. The user can remove segment 104b of the foam assembly 104, allowing the foam assembly to occupy less space within the target site 170 and enabling the target site 170 to continue shrinking as it heals. The user can disconnect tube 116b of the tubular assembly 116 from the vacuum source. The user can then retract tube 116b above tubes 116c and 116d, causing segment 104b to move proximally above segments 104c and 104d and above tubes 116c and 116d. Segment 104b and tube 116b can be removed from the patient, while segments 104c and 104d and tubes 116c and 116d remain within the target site 170.

[0058] The user can repeat these steps until segment 104d (the innermost segment of foam component 104) is exposed to the target site 170. Once treatment is complete, the user can completely remove the EVAC device 100 from the patient by withdrawing tube 116d to remove segment 104d from the target site 170.

[0059] 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 examples should be considered as exemplary only.

Claims

1. A medical device comprising: A tubular assembly comprising a plurality of tubes, wherein each of the plurality of tubes is configured to be coupled to a vacuum source to deliver negative pressure to the distal end of a corresponding tube; and A porous assembly comprising multiple segments and connected to the distal end of the tubular assembly, wherein each of the multiple segments is connected to a corresponding tube among the multiple tubes.

2. The medical device according to claim 1, wherein, Each of the plurality of tubes includes one or more walls that define a channel for delivering negative pressure to a segment of the plurality of sections corresponding to the channel.

3. The medical device according to claim 2, wherein, The first channel of the innermost tube among the multiple tubes extends from the proximal end to the distal end of the innermost tube, and the central longitudinal axis of the medical device extends through the first channel.

4. The medical device according to claim 3, wherein, The second channel of the outermost tube in the plurality of tubes extends from the proximal end to the distal end of the outermost tube in the plurality of tubes, and wherein the second channel extends radially around the central longitudinal axis of the medical device.

5. The medical device according to claim 2, wherein, Each of the plurality of segments includes an opening in fluid communication with the channel of the corresponding pipe in the plurality of tubes, and wherein the opening of each of the plurality of segments is independent of the openings of the other segments in the plurality of segments.

6. The medical device according to claim 2, wherein, Each of the plurality of tubes has a channel with a proximal opening and a distal opening, wherein the proximal opening of the channel is connected to the vacuum source, and the distal opening is connected to the proximal opening of a corresponding segment among the plurality of segments.

7. The medical device according to any one of the preceding claims, wherein, The multiple segments are configured to be removed individually from the target site within the body cavity.

8. The medical device according to any one of the preceding claims, wherein, The outermost tube of the plurality of tubes is connected to the outermost segment of the plurality of segments, and wherein the proximal movement of the outermost tube relative to the other tubes of the plurality of tubes causes the outermost segment of the plurality of segments to retract above the remaining segments of the plurality of segments.

9. The medical device according to any one of the preceding claims, wherein, The multiple pipes are configured to deliver negative pressure to only one of the multiple sections at a time.

10. The medical device according to any one of the preceding claims, wherein, Each of the plurality of segments includes an inner surface and an outer surface, wherein the outer surface of each of the plurality of segments includes one or more of a rough portion and a coating, the rough portion being used to collect exudate from the target site, and the coating being used to prevent tissue from growing inward.

11. The medical device according to any one of the preceding claims, wherein, Each of the plurality of segments includes a cap located at the farthest side of each of the plurality of segments.

12. The medical device according to any one of the preceding claims, wherein, The diameter of the distal end of each of the plurality of tubes is aligned with the diameter of the proximal end of the corresponding segment of the plurality of segments.

13. The medical device according to any one of the preceding claims, wherein, The porous assembly includes at least four segments, and the tubular assembly includes at least four tubes, wherein a first segment is connected to a first tube, a second segment is connected to a second tube, a third segment is connected to a third tube, and a fourth segment is connected to a fourth tube.

14. The medical device according to claim 13, wherein, The first segment is cylindrical, the second segment extends around the first segment, the third segment extends around the second segment, and the fourth segment extends around the third segment.

15. The medical device according to claim 13, wherein, The first tube is nested inside the second tube, the second tube is nested inside the third tube, and the third tube is nested inside the fourth tube.

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