Luminous Endoscopic Therapeutic Devices and Related Methods

Abstract

The medical device may include an implant having multiple openings, a tube having a through-lumen, a body extending from the distal end of the tube to the proximal end of the implant such that the multiple openings communicate with the lumen, and a gripping portion configured to be grasped by a second medical device.

Description

Technical Field

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

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. The mortality rate of patients with perforation, postoperative leakage, and / or other wounds in the GI tract is high, and the treatment options are limited. The options include endoscopic clip or stent placement, endoscopic suturing or sealants, or surgical reoperation. Surgery is relatively invasive and has a high morbidity and mortality rate. Endoscopic stenting is a less invasive option, but the stent may move from the intended position and / or enclose the infection at the treatment site and prevent drainage.

[0003] The medical devices 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 an implant having a plurality of openings, a tube having a lumen therethrough, and a body extending from a distal portion of the tube to a proximal portion of the implant such that the plurality of openings can communicate with the lumen. The medical device can further include a gripping portion configured to be gripped by a second medical device.

[0005] Any embodiment disclosed herein may include any one or any combination of the following features: The gripping portion may include at least one of a tab, a strap, or an opening. The tube may be removably coupled to the body. The distal portion of the body may be wider than the proximal portion of the body. The distal opening of the body may be configured to receive the proximal portion of the implant, and the proximal opening of the body may be configured to receive the distal portion of the tube. A first portion of the distal opening may be distal to a second portion of the distal opening. The body may include a lumen extending from the distal opening to the proximal opening. The proximal portion of the implant may be compressed within the body. The tube may be configured to supply negative pressure to the implant by being coupled to a vacuum source. The gripping portion may include at least one opening formed on the radially outer surface of the body. The at least one opening may be located adjacent to the distal opening of the body. The gripping portion may include at least one strap fixed to the radially outer surface of the main body. The gripping portion may include at least one tab extending radially outward from the implant. The protruding portion of the at least one tab may extend radially beyond the radially outer surface of the implant. The implant may be positioned on a portion of the main body, and the gripping portion may include a ring positioned on the implant and the main body. The gripping portion may include a tab extending from the ring.

[0006] In another example, the medical device may include an implant having a plurality of openings, a tube having a through-lumen communicating with the plurality of openings, a body extending from a proximal end to a distal end, and a gripping portion configured to be grasped by a second medical device. The body tapers radially inward from the distal end to the proximal end, and the implant can be connected to the tube.

[0007] Any embodiment disclosed herein may include any one or any combination of the following features: The distal end of the body may be angled; the first portion of the distal opening of the body may be distal to the second portion of the distal opening of the body; the gripping portion may include an opening formed on the radially outer surface of the body; the opening may be adjacent to the outer edge of the distal opening.

[0008] In a further embodiment, the medical device may include an implant having a plurality of openings and a tube having a lumen through which it passes. The tube may be configured to be connected to a vacuum source. The medical device may further include a body connecting the implant to the tube so that the plurality of openings communicate with the lumen, and a gripping portion configured to be grasped by a second medical device. The gripping portion may include at least one of a tab, a strap, or an opening. The body may include the gripping portion. [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. [Figure 4] Another exemplary medical device according to aspects of this disclosure is shown. [Figure 5A] Figures 5A to 5D show further exemplary medical devices according to aspects of this disclosure. [Figure 5B] Same as above. [Figure 5C] Same as above. [Figure 5D]Same as above. [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 such as postoperative leakage or perforation in the gastrointestinal tract (GI) after surgical or endoscopic procedures such as colectomy, bariatric surgery, or esophagectomy. In EVAC, negative pressure is applied 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. The sponge is inserted into the perforation, leakage, or other wound by endoscopy. In some cases, EVAC involves endoscopic placement of a sponge or other similar material into the wound site (e.g., target) such as a perforation, leakage, cyst, or anastomosis. Placement of the material is performed by inserting a catheter, scope (endoscope, bronchoscope, colonoscope, duodenoscope, gastroscopy, etc.), tube, or sheath into the GI tube through a natural opening. The above-mentioned opening may be, for example, the nose, mouth, or anus, and the placement may be 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). Negative pressure is then applied.

[0014] Foam within a 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. Suitable devices and systems for EVAC are limited. During EVAC, foam can be delivered to the target site using a scope, rat-tooth forceps, and a suture loop at the distal end of the foam. For example, rat-tooth forceps can be extended through the working channel of the scope to grasp the loop at the distal end of the foam. While rat-tooth forceps can be used to move the foam to the target site when maneuvering the scope toward the target site, this can be difficult. For example, when the user moves the foam through the GI tube using rat-tooth forceps, the foam may obstruct the scope's visibility. Furthermore, while the suture loop may be helpful in initially positioning the foam near the target site, its non-rigid structure may prevent it from effectively positioning the foam within or near the target site. For example, suture loops may not be useful for positioning foam in difficult target areas, such as the cardia region in sleeve gastrectomy.

[0015] Removing the foam from the target site during EVAC is also a challenge. For example, if left in the target site for a long period, tissue may grow within the foam, making it difficult to remove the foam from the target site when it needs to be replaced. Therefore, in EVAC, the foam usually needs to be replaced every 3 to 5 days to prevent internal growth and maintain cleanliness of the target site.

[0016] Aspects of the present disclosure include devices and methods for improving the delivery of implants (e.g., foam) to target sites and / or implant replacement during EVAC. For example, aspects of the present disclosure include devices and methods for reducing the time required to deliver implants (e.g., foam) to target sites and / or reducing the time required to remove implants from target sites. For example, aspects of the present disclosure may improve the replacement of implants (e.g., foam) at target sites.

[0017] The components of the devices described herein can be packaged as a kit for EVAC. For example, the devices disclosed herein may include a connector coupled to the proximal end of a foam. In some embodiments, the connector may be configured to connect a vacuum tube to the foam for wound treatment. In some embodiments, the connector may form a rigid bond with the vacuum tube and the foam. In some embodiments, the connector may include an opening or loop configured to receive the distal end of an instrument. In some examples, the connector allows for rapid replacement of the foam during EVAC procedures. In some embodiments, the connector may allow for improved visibility of the foam as it is delivered to the target site.

[0018] 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 that is inserted into a patient for the treatment of a wound or used in some other way to assist in the treatment of tissue. The EVAC device 100 can include a foam 102 (implant), such as a sponge or other porous body, a vacuum tube 104 or other type of conduit, and a connector 114. The connector 114 can include a body 115 that extends from the distal portion 112 of the vacuum tube 104 to the proximal portion 116 of the foam 102. The connector 114 can be at least one of a tab, a ring, or a pocket that extends from the foam 102 and / or the vacuum tube 104. The connector 114 will be described in more detail below.

[0019] The foam 102 can have any characteristics of any foam known in the art for use in an EVAC procedure. For example, the foam 102 can include an open-cell foam. The foam 102 may include openings 106 on its outer surface and / or inside. The openings 106 can be any holes, pores, or channels. The openings 106 can include interconnected channels and / or pores throughout the foam 102. For example, the openings 106 can be the pores of the foam 102. The openings 106 can have various sizes and / or shapes. The characteristics of the openings 106 (e.g., the size and shape of the pores of the foam 102) can be selected based on the location of the treatment in the body, the characteristics of the wound being treated, the stage of the treatment, or other factors. Although the foam 102 is shown as having a cylindrical shape, it can be any shape, such as spherical, cuboid, irregular, etc. The foam 102 can be compressed to a lower-profile shape during insertion into the target site and expanded during deployment at the target site.

[0020] The form 102 can include any suitable biocompatible material that can absorb liquids and / or allow liquids or other substances to pass through, for example, via a negative pressure applied to the form 102. The material of the form 102 can be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. Suitable materials include polyurethane, ester, ether, composite materials, and / or other medical grade materials.

[0021] The vacuum tube 104 can include an outer wall 108 that defines one or more lumens 110. The lumen 110 can open at both the proximal end (not shown) and the distal portion 112 of the vacuum tube 104 that is within or coupled to the form 102. The opening 106 of the form 102 can communicate with the distal opening of the vacuum tube 104. The proximal end of the vacuum tube 104 may be connected to a vacuum source (not shown), and the vacuum source can supply a negative pressure to the form 102 through the distal opening of the vacuum tube 104. For example, a negative pressure of about 125 mmHg, or about 17.2 kPa (about 2.5 pounds per square inch (PSI)) can be supplied to the form 102 through the vacuum tube 104. Other suitable amounts of negative pressure can also be used. The negative pressure can promote the healing of the target site by drawing fluids, substances, and / or other debris into the lumen 110 of the vacuum tube 104 through the opening 106 of the form 102.

[0022] As described above, the connector 114 may include a body 115 extending from the distal portion 112 of the vacuum tube 104 to the proximal portion 116 of the form 102. The body 115 of the connector 114 may include a radially outer surface 132, a proximal opening 126 at the nearest end of the body 115, and a distal opening 128 at the most distal end of the body 115. The lumen 120 (shown by a dashed line to indicate the internal features of the body 115) may extend through the body 115 from the proximal opening 126 to the distal opening 128. The most distal end of the body 115 may be tapered or angled such that the first portion 134 of the distal opening 128 is distal to the second portion 138 of the distal opening 128 (as shown in Figure 1B). In other words, the tip of the body 115 has a beveled shape, and the distal opening 128 has an elongated shape. In another example, the distal opening 128 of the connector 114 may be substantially perpendicular to the longitudinal axis of the connector 114, or may have any other suitable shape, size, and / or orientation.

[0023] The body 115 of the connector 114 may taper radially inward from its distal end to its nearest end. The distal portion 122 of the lumen 120 may be wider than the proximal portion 118 of the lumen 120. The proximal portion 118 of the lumen 120 may be configured to receive the distal portion 112 of the vacuum tube 104. For example, the distal portion 112 of the vacuum tube 104 may extend distally through the proximal opening 126 and the proximal portion 118 of the lumen 120 of the body 115. The inner wall of the proximal portion 118 of the lumen 120 may contact a portion of the outer wall 108 of the distal portion 112 of the vacuum tube 104, thereby securely fixing the connector 114 to the distal portion 112 of the vacuum tube 104. In some examples, the connector 114 may be fixed to the distal portion 112 of the vacuum tube 104. In some examples, the connector 114 may consist of a heat-shrinkable or moldable material formed on the outer wall 108 of the distal portion 112 of the vacuum tube 104 and / or on the proximal portion 116 of the form 102, as described later. In some examples, the distal portion 112 of the vacuum tube 104 may extend further through the distal portion 122 of the lumen 120.

[0024] The distal portion 122 of the lumen 120 may be configured to receive the proximal portion 116 of the form 102. For example, the distal portion 122 of the lumen 120 may form a pocket or cavity of a size and shape that can accommodate the proximal portion 116 of the form 102. The proximal portion 116 of the form 102 may be compressed when placed within the distal portion 122 of the lumen 120. Alternatively, the proximal portion 116 of the form 102 may have a smaller diameter / width than the more distal portion of the form 102 in its natural / relaxed configuration. In an assembled configuration, the proximal portion 116 of the form 102 may be positioned adjacent to the distal portion 112 of the vacuum tube 104 within the lumen 120. For example, the distal portion 112 of the vacuum tube 104 may extend to the proximal portion 116 of the form 102. The distal portion 112 of the vacuum tube 104 may be attached to the form 102 via sutures or other knots, adhesives, shrink wrap materials, elastic bodies, etc. In one example, the form 102 (for example, the proximal portion 116 of the form 102) may be provided with a recess or neck (not shown) to receive the distal portion 112 of the vacuum tube 104.

[0025] The body 115 of the connector 114 may have a shape similar to the strain relief portion. The body 115 may have a tapered shape that gradually extends radially outward from a width / diameter similar to that of the vacuum tube 104 to a width / diameter similar to that of the proximal portion 116 of the form 102. In other words, the connector 114 can transition between the vacuum tube 104 and the form 102.

[0026] In some examples, the body 115 of the connector 114 may be rigid so that the body 115 maintains its original shape, for example, when grasped by an instrument. The connector 114 is firmly coupled to the foam 102 and the vacuum tube 104, so that the movement and / or operation of the connector 114 corresponds approximately one-to-one with the movement and / or operation of the foam 102 and the vacuum tube 104. Furthermore, the rigid coupling between the connector 114 and the foam 102 (and the vacuum tube 104) allows for the transmission of directional forces to move and / or manipulate the foam 102 to a target site. Alternatively, the body 115 may be flexible.

[0027] The body 115 may include a lateral opening 130 formed on the radially outer surface 132 that communicates with the lumen 120. The lateral opening 130 may be located adjacent to the outer edge of the first portion 134 of the distal opening 128. Alternatively, the lateral opening 130 may be located on any portion of the radially outer surface 132. The lateral opening 130 may be configured to receive a gripping device 142 for delivering the form 102 to a target site, or any suitable medical device such as an extension rod or hook. The lateral opening 130 may form a tag 131 (referenced in Figure 1A) between the distal end of the opening 130 and the most distal edge of the body 115. The gripping device 142 can grasp the tag 131. The lateral opening 130 may be of any suitable size and / or shape (e.g., circular or elliptical). For example, the first arm 144 of the gripping device 142 may pass through the side opening 130, and the second arm 146 of the gripping device 142 may be closed on the radially outer surface 132 to grip the connector 114. As shown in Figures 1A and 1B, the distal ends of the arms 144 and 146 may be adjacent to the outer edge of the first portion 134 of the distal opening 128 and coupled to each other. The arrangement of the opening 130 and the gripping device 142 in Figures 1A and 1B is merely illustrative. Alternatively, the tag 131 may be located proximal to the opening 130. The gripping device 142 or another device may face radially outward, distally, and / or proximally when gripping the tag 131.

[0028] Figure 2 shows the distal end of another exemplary EVAC device 200. Unless otherwise specified herein, the EVAC device 200 may have similar characteristics to the EVAC device 100. Where possible, the reference number 100 is added to the reference number associated with the EVAC device 100 for embodiments similar to the EVAC device 200. The EVAC device 200 may include a foam 202 (implant), such as a sponge or other porous material, a vacuum tube 204, and a connector 214. Similar to the vacuum tube 104, the vacuum tube 204 may include an outer wall 208 and a lumen 210, and the proximal end of the vacuum tube 204 may be connected to a vacuum source (not shown). The opening 206 of the form 202 communicates with the lumen 210 of the vacuum tube 204, so that when negative pressure is supplied to the lumen 210, the negative pressure can draw fluid, material, and / or other debris from the target site into the lumen 210 of the vacuum tube 204 through the opening 206 or the form 202.

[0029] Similar to connector 114, connector 214 may include a body 215 extending from the distal portion 212 of the vacuum tube 204 to the proximal portion 216 of the form 202. The body 215 may include a radially outer surface 232, a proximal opening 226, and a distal opening 228. A lumen (not shown in Figure 2, but having any characteristics of lumen 120) may extend through the body 215 from the proximal opening 226 to the distal opening 228. Similar to lumen 120, the distal portion of the lumen of body 215 may be wider than the proximal portion of the lumen of body 215. The proximal portion of the lumen of body 215 may be configured to receive the distal portion 212 of the vacuum tube 204, and the distal portion of the lumen of body 215 may be configured to receive the proximal portion 216 of the form 202. Form 202, vacuum tube 204, and connector 214 may be connected to and / or assembled to each other in the same or similar manner as described above for the EVAC device 100.

[0030] The body 215 of the connector 214 may include a plurality of lateral openings 230 on its radially outer surface 232 that communicate with the lumen of the body 215. Like the body 115, the body 215 may be rigid. In some examples, the body 215 may be made from a rigid elastomer. Like the lateral openings 130, the lateral openings 230 may be any appropriate size and / or shape configured to receive the distal end of a suitable medical instrument such as a gripper 142 (Figures 1A-1B), extension rod, or hook. The lateral openings 230 allow the gripper 142 to be securely fixed to the connector 214 from multiple sides of the connector 214 (where any of the lateral openings 230 are located) and to deliver the foam 202 to the target site. The plurality of lateral openings 230 allow one or more instruments to simultaneously grip different parts of the body 215 of the connector 214.

[0031] Figure 3 shows the distal end of another exemplary EVAC device 300. Unless otherwise specified herein, the EVAC device 300 may have similar characteristics to the EVAC devices 100 and / or 200. Where possible, a reference number 200 is added to the reference number associated with the EVAC device 100 for similar embodiments of the EVAC device 300. The EVAC device 300 may include a foam 302 (i.e., implant), such as a sponge or other porous material, a vacuum tube 304, and a connector 314. 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 opening 306 of the form 302 communicates with the lumen 310 of the vacuum tube 304, and when negative pressure is supplied to the lumen 310, the negative pressure can draw fluid, material, and / or other debris from the target site into the lumen 310 of the vacuum tube 304 through the opening 306 of the form 302.

[0032] Similar to connector 114, connector 314 may include a body 315 extending from the distal portion 312 of the vacuum tube 304 to the proximal portion 316 of the form 302. The body 315 may include a radially outer surface 332, a proximal opening 326, and a distal opening 328. A lumen having any of the characteristics of the lumen 120 may extend through the body 315 from the proximal opening 326 to the distal opening 328. The distal portion of the lumen of the body 315 may be wider than the proximal portion of the lumen of the body 315. The proximal portion of the lumen of the body 315 may be configured to receive the distal portion 312 of the vacuum tube 304, and the distal portion of the lumen of the body 315 may be configured to receive the proximal portion 316 of the form 302. The form 302, the vacuum tube 304, and the connector 314 may be joined and / or assembled to each other in the same or similar manner as described above for the EVAC device 100. Similar to the body 215, the body 315 may be rigid (e.g., made of a rigid elastomer) or may contain any suitable alternative material.

[0033] The body 315 of the connector 314 may include a number of straps 348 arranged on the radially outer surface 332. Figure 3 shows two straps 348, but in some examples any number of straps 348 may be arranged on the radially outer surface 332. The first end 354 of the strap 348 is fixed to the radially outer surface 332, and the loop portion 356 of the strap 348 may extend radially outward. The second end 357 of the strap 348 may be fixed to the radially outer surface 332. For example, the second end 357 may be fixed distal to the first end 354. The strap 348 may be any appropriate size and / or shape configured to receive the distal end of a suitable medical device such as a gripping device 142, extension rod, or hook. The strap 348 securely fastens the gripping device 142 to the connector 314 from either side of the connector 314, allowing the foam 302 to be delivered to the target site. The strap 348 may be elastic or inelastic and can be made from any suitable material.

[0034] Figure 4 shows the distal end of another exemplary EVAC device 400. Unless otherwise specified herein, the EVAC device 400 may have similar properties to the EVAC device 100. Where possible, the reference number 300 is added to the reference number associated with the EVAC device 100 that is similar to an embodiment of the EVAC device 400. The EVAC device 400 may include a foam 402 (i.e., implant), such as a sponge or other porous material, a vacuum tube 404, and a connector 414. Similar to the vacuum tube 104, the vacuum tube 404 may include an outer wall 408 and a lumen 410, and the proximal end of the vacuum tube 404 may be connected to a vacuum source (not shown). An opening 406 in the foam 402 communicates with the lumen 410 of the vacuum tube 404, and when negative pressure is supplied to the lumen 410, the negative pressure may draw fluid, material, and / or other debris from the target site into the lumen 410 of the vacuum tube 404 through the opening 406.

[0035] Similar to connector 114, connector 414 may include a body 415 extending from the distal portion 412 of the vacuum tube 404 to the proximal portion 416 of the form 402. As shown in Figure 4, the body 415 may be relatively shorter in the longitudinal / axial direction than the bodies 115, 215, and 315. As shown in Figure 4, the distal portion 412 of the vacuum tube 404 may extend into the form 402 (for example, into a recess formed within the form 402). EVAC devices 100, 200, and 300 may have similar arrangements. In some examples, the form 402, the vacuum tube 404, and connector 414 may be coupled and / or assembled to each other in the same or similar manner as described above for EVAC device 100.

[0036] The EVAC device 400 may further include a tab 448 extending radially outward from the side of the form 402 (for example, a portion of the form 402 between the proximal portion 416 and the distal portion 417 of the form 202). For example, the tab 448 may be positioned approximately in the center of the form 402 in the axial direction. In some embodiments, the tab 448 may be positioned at or near the most distal end of the vacuum tube 404. In some examples, the tab 448 may be coupled to the vacuum tube 404 and extend through the sidewall of the form 402. Alternatively, the tab 448 may be positioned at any suitable alternative location along the axial length of the form 402. Although one tab 448 is illustrated, it will be understood that the EVAC device 400 may include any suitable number of tabs at any suitable location. For example, multiple tabs 448 may be positioned along the form 402 at different axial and / or radial locations. The protruding portion 452 of the tab 448 may extend radially beyond the radially outer surface of the form 402.

[0037] The tab 448 and connector 414 may be rigid and / or made of a rigid elastomer. Alternatively, the tab 448 may be flexible (elastic or inelastic). The tab 448 can be of any appropriate size and / or shape configured to receive the distal end of a suitable medical device such as a gripper 142, extension rod, or hook. The tab 448 securely connects the gripper 142 to the foam 402 and / or vacuum tube 404, allowing the foam 402 to be delivered to the target site.

[0038] It will be understood that the bodies 115, 215, 315, and 415 of the connectors 114, 214, 314, and 414 may include at least one and / or any combination of the aforementioned side openings 130, 230, straps 348, or tabs 448 to facilitate delivery of the foams 102, 202, 302, and 402 to the target site. The side openings 130, 230, straps 348, and / or tabs 448 may be located in multiple different areas of the bodies 115, 215, 315, and 415 and may be oriented in any direction, including outward, posterior / proximal, or anterior / distal. This will allow the connectors 114, 214, 314, and 414 to be easily grasped or locked by an instrument.

[0039] Figures 5A–5D show the distal end of another exemplary EVAC device 500. Unless otherwise specified herein, the EVAC device 500 may have similar properties to the EVAC device 100. Where possible, reference numeral 400 is added to the reference numeral associated with the EVAC device 100 for embodiments similar to the EVAC device 500. The EVAC device 500 may include a foam 502 (implant), such as a sponge or other porous material, and a vacuum tube 504. Similar to the vacuum tube 104, the vacuum tube 504 may include an outer wall and a lumen. The proximal end of the vacuum tube 504 may be connected to a vacuum source (not shown). An opening in the foam 502 (having any of the properties of an opening described above) may communicate with the lumen of the vacuum tube 504, and when negative pressure is supplied to the lumen, the negative pressure may draw fluid, material, and / or other debris from the target site into the lumen of the vacuum tube 504 through the opening in the foam 502.

[0040] The connector 514 of the EVAC device 500 may be configured to improve the replacement of the foam 502 during EVAC procedures. For example, the connector 514 allows for easy replacement of a larger size foam 502 with a smaller size foam 502 at the target site as the wound at the target site heals. The distal end of the connector 514 may be positioned within a recess (not shown) of the foam 502.

[0041] In some examples, the connector 514 may include a collet 562 and a housing member 570. In some examples, the form 502 may be positioned on the housing member 570 of the connector 514. The collet 562 may be housed within the lumen of the housing member 570. The collet 562 may have any suitable configuration and may be configured to hold the vacuum tube 504 in a releasable manner. The connector 514 may also include a seal (e.g., an O-ring) or other structure within the housing member 570. The connector 514 may have alternative configurations configured to hold the vacuum tube 504 in a releasable manner. The connector 514 is analogous to a quick-connect or push-to-connect fitting and may have the characteristics of any quick-connect or push-to-connect fitting known in the art.

[0042] As described above, the connector 514 may include a collet 562. The collet 562 may include a flange 566 and a stem 568 (see Figure 5C). The stem 568 may be housed within a housing member 570. The flange 566 may be located on the proximal side of the housing member 570. The collet 562 may be movable in the proximal and / or distal directions relative to the housing member 570. In some examples, the flange 566 may define a stopper that prevents the collet 562 from moving distally beyond the distal wall of the flange 566.

[0043] The flange 566 may define an opening 567 (see Figures 5C and 5D) for receiving the distal end of the vacuum tube 504. The opening 567 may be a proximal opening of a lumen that longitudinally penetrates the collet 562 (including the flange 566 and the stem 568). The lumen may also have a distal end that opens to the distal end of the stem 568 (not shown). The opening 567 may be configured to receive the distal portion 512 of the vacuum tube 504. The vacuum tube 504 may be releasably coupled to the connector 514 via the collet 562. In some examples, the vacuum tube 504 can be secured to the connector 514 by pushing the distal end of the vacuum tube 504 distally through the opening 567 in the flange 566 of the collet 562 (the vacuum tube 504 may also interact with the seal in the housing member 570). In some examples, pushing the flange 566 of the collet 562 distally (for example, relative to the housing member 570) releases the vacuum tube 504 from the connector 514, so that the vacuum tube 504 can be pulled proximal and removed from the lumen of the collet 562 through the opening 567.

[0044] The EVAC device 500 may further include a gripping portion 556. The gripping portion 556 may include a ring portion 558 (see Figure 5B) configured to extend over the housing member 570 (or another part of the connector 514) of the connector 514 and the form 502. The ring portion 558 may be flexible so that it can be stretched and positioned over the form 502. When released, the ring portion 558 can be compressed over the form 502. The ring portion 558 may interact with grooves (not shown) formed on the radially outer surface of the housing member 570 (or another part of the connector 514) of the connector 514 within the form 502. The gripping portion 556 may include a tab 560 (e.g., an extension) extending from the ring portion 558. The tab 560 allows an instrument such as a gripper 142 to be locked onto the tab 560 and move the form 502 to a target site, as described above. In some examples, the tab 560 may be made of a rigid elastomer. Alternatively, the tab 560 (and other parts of the gripping portion 556) may be formed of a flexible material.

[0045] The components of the medical device 500 may be packaged in a kit. For example, the kit may include foams 502 of various sizes, each coupled to a corresponding connector 514, to assist in the treatment of target sites of various sizes. For example, as a wound at a target site begins to heal, the target site shrinks. Therefore, the foam initially used to treat the wound may not be the ideal size for treating the wound several days later. This kit allows the user to select the size of the foam 502 coupled to each connector 514 based on the location or size of the wound. The user can easily connect a vacuum tube 504 to the foam 502 via the connector 514 along with a vacuum source and treat the wound.

[0046] Next, an exemplary method of using the device 500 will be described. The user can select a form 502 of a specific size and its corresponding connector 514 based on the size and location of the target area within the GI tube. The gripping portion 556 can be pre-fixed to the form 502. Alternatively, the user can fix the gripping portion 556 to the form 502 and / or connector 514 by placing the ring portion 558 on the form 502 and positioning the ring portion 558 in a groove on the radially outer surface of the housing member 570 (or another part of the connector 514) of the connector 514. The distal portion 512 of the vacuum tube 504 can then be fixed to the connector 514 via the collet 562. For example, the user can insert the distal portion 512 of the vacuum tube 504 into the opening 567.

[0047] Next, the endoscope can be inserted into the GI tube through the natural opening, and the form 502 can be guided through the endoscope's working channel to position the form 502 at or near the target site. The form 502 can be positioned at the target site by passing an instrument or other accessory, such as a gripping device 142 (Figures 1A-1B), through the working channel to grasp the tab 560 of the gripping section 556. Next, by supplying negative pressure to the vacuum tube 504 via a vacuum source, fluid, material, and / or other debris are drawn into the lumen of the vacuum tube 504 through the opening of the form 502, thereby promoting healing of the target site. The endoscope may be removed, and the form 502 and vacuum tube 504 can remain inside the body of the subject. In some examples, the vacuum tube 504 may be a nasogastric tube that can exit through the nose of the subject.

[0048] After an appropriate period (e.g., 3-5 days), the user can remove the form 502 (e.g., through the mouth of the target) and detach the connector 514 along with the form 502 from the distal portion 512 of the vacuum tube 504, as described above with respect to Figures 5A-5D. The user can then select another form 502 (e.g., a form 502 of a different size) and its corresponding connector 514 based on its characteristics (e.g., the adjusted size of the target site). Next, the distal portion 512 of the vacuum tube 504 can be prepared for placement on the target site by securing it to the connector 514 of the new form 502 via the collet 562 (as described above). The user can then insert the new form 502 using an endoscope.

[0049] It will be apparent to those skilled in the art that various modifications and changes can be made to the disclosed devices and methods 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, An implant having multiple openings, A tube having a through-lumen, A main body extending from the distal portion of the tube to the proximal portion of the implant, such that the multiple openings can communicate with the lumen, A gripping portion configured to be grasped by a second medical device and Medical devices including those mentioned.

2. The medical device according to claim 1, wherein the gripping portion includes at least one of a tab, a strap, or an opening.

3. The medical device according to claim 1 or 2, wherein the tube is detachably connected to the main body.

4. The medical device according to any one of claims 1 to 3, wherein the distal portion of the main body is wider than the proximal portion of the main body.

5. The medical device according to any one of claims 1 to 4, wherein the distal opening of the main body is configured to receive the proximal portion of the implant, and the proximal opening of the main body is configured to receive the distal portion of the tube.

6. The medical device according to claim 5, wherein the first portion of the distal opening is distal to the second portion of the distal opening.

7. The medical device according to claim 5, wherein the main body includes a lumen extending from the distal opening to the proximal opening.

8. The medical device according to any one of claims 1 to 7, wherein the proximal portion of the implant is compressed within the main body.

9. The medical device according to any one of claims 1 to 8, wherein the tube is configured to supply negative pressure to the implant by being connected to a vacuum source.

10. The medical device according to any one of claims 1 to 9, wherein the gripping portion includes at least one opening formed on the radially outer surface of the main body, and the at least one opening is located adjacent to the distal opening of the main body.

11. The medical device according to any one of claims 1 to 10, wherein the gripping portion includes at least one strap fixed to the radially outer surface of the main body.

12. The medical device according to any one of claims 1 to 11, wherein the gripping portion includes at least one tab extending radially outward from the implant.

13. The medical device according to claim 12, wherein the protruding portion of at least one tab extends radially beyond the radially outer surface of the implant.

14. The medical device according to any one of claims 1 to 13, wherein the implant is positioned on a part of the main body, and the gripping portion includes a ring positioned on the implant and the main body.

15. The medical device according to claim 14, wherein the gripping portion includes a tab extending from the ring.

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